As
filed with the Securities and Exchange Commission on January 19, 2016.
Registration
No. 333- 208818
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
Amendment
No.1
to
FORM
S-1
REGISTRATION
STATEMENT UNDER
THE
SECURITIES ACT OF 1933
RITTER
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
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2834
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26-3474527 |
(State
or other jurisdiction of
incorporation
or organization) |
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(Primary
Standard Industrial
Classification
Code Number) |
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(I.R.S.
Employer
Identification
Number) |
1880
Century Park East #1000
Los
Angeles, CA 90067
(310)
203-1000
(Address,
including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
Michael
D. Step
Chief
Executive Officer
Ritter
Pharmaceuticals, Inc.
1880
Century Park East #1000
Los
Angeles, CA 90067
(310)
203-1000
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Copies
to:
Michael
Sanders, Esq.
David
T. Mittelman, Esq.
Reed
Smith LLP
1901
Avenue of the Stars, Suite 700
Los
Angeles, California 90067-6078
Telephone:
(310) 734-5200
Approximate
date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration
statement.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, check the following box. [X]
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
[ ] |
Accelerated
filer |
[ ]
|
Non-accelerated
filer |
[ ]
(Do not check if a smaller reporting company) |
Smaller reporting
company |
[X] |
The
Registrant is an “emerging growth company,” as defined in Section 2(a) of the Securities Act. This registration statement
complies with the requirements that apply to an issuer that is an emerging growth company.
The
Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until
the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective
on such date as the Commission, acting pursuant to such Section 8(a), may determine.
The
information in this preliminary prospectus is not complete and may be changed. The selling stockholder may not sell these securities
until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is
not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the
offer or sale is not permitted.
PRELIMINARY
PROSPECTUS |
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SUBJECT
TO COMPLETION |
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DATED
January 19, 2016 |
![](http://www.sec.gov/Archives/edgar/data/1460702/000149315216006847/image_001.jpg)
1,577,699
Shares
Common
Stock
This
prospectus relates to the sale of up to 1,577,699 shares of our common stock by Aspire Capital Fund, LLC, or Aspire Capital. Aspire
Capital is also referred to in this prospectus as the selling stockholder. The prices at which the selling stockholder may sell
the shares will be determined by the prevailing market price for the shares or in negotiated transactions. We will not receive
proceeds from the sale of the shares by the selling stockholder. However, we have received proceeds of $1.0 million, and may receive
additional proceeds of up to $9.0 million, for an aggregate of $10.0 million, from the sale of our common stock to the selling
stockholder, pursuant to a common stock purchase agreement entered into with the selling stockholder on December 18, 2015.
The
selling stockholder is an “underwriter” within the meaning of the Securities Act of 1933, as amended. We will pay
the expenses of registering these shares, but all selling and other expenses incurred by the selling stockholder will be paid
by the selling stockholder.
Our
common stock is listed on the Nasdaq Capital Market under the ticker symbol “RTTR.” On January 15, 2016 the
last reported sale price per share of our common stock was $1.33 per share.
You
should read this prospectus and any prospectus supplement, together with additional information described under the headings “Incorporation
of Certain Documents by Reference” and “Where You Can Find More Information,” carefully before you invest in
any of our securities.
Investing
in our securities involves a high degree of risk. See “Risk Factors” on page 8 of this prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is , 201 6 .
TABLE
OF CONTENTS
Neither
we nor the selling stockholder has authorized anyone to provide any information or to make any representations other than as contained
in this prospectus or in any free writing prospectuses we have prepared. We and the selling stockholder take no responsibility
for, and provide no assurance as to the reliability of, any information that others may give you. This prospectus is an offer
to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information
contained in this prospectus is current only as of its date.
For
investors outside of the United States: Neither we nor the selling stockholder have done anything that would permit this offering
or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in
the United States. You are required to inform yourselves about, and to observe any restrictions relating to, this offering and
the distribution of this prospectus outside of the United States.
PROSPECTUS
SUMMARY
This
summary highlights certain information about us, this offering and selected information contained in the prospectus. This
summary is not complete and does not contain all of the information that you should consider before deciding whether to
invest in our common stock. For a more complete understanding of our company and this offering, we encourage you to read
and consider the more detailed information in the prospectus, including “Risk Factors” and the financial statements
and related notes. Unless we specify otherwise, all references in this prospectus to “Ritter Pharmaceuticals,”
“we,” “our,” “us” and “our company” refer to Ritter Pharmaceuticals, Inc.
Our
Business
Ritter
Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal
diseases. We are advancing human gut health research by exploring the metabolic capacity of the gut microbiota and translating
the functionality of prebiotic-based therapeutics into applications intended to have a meaningful impact on a patient’s
health. “Prebiotics” is a general term used to refer to chemicals that induce the growth and/or activity of
commensal microorganisms that contribute to the well-being of their host.
Our
first novel microbiome modulator, RP-G28, an orally administered, high purity galacto-oligosaccharide (a carbohydrate
found naturally, at least in small amounts, in plants, consisting of three to ten simple sugars linked together), is currently
under development for the reduction of symptoms associated with lactose intolerance. RP-G28, is designed to stimulate
the growth of lactose-metabolizing bacteria in the colon, thereby effectively adapting the gut microbiome to assist in
digesting the lactose that reaches the large intestine. RP-G28 has the potential to become the first drug approved by
the U.S. Food and Drug Administration, or FDA, for the reduction of symptoms associated with lactose intolerance. RP-G28
has been studied in a Phase 2a clinical trial and is a first-in-class compound.
Our
Market Opportunity
Lactose
intolerance is a common condition attributed to insufficient levels of the enzyme lactase, which is needed to properly
digest lactose, a complex sugar found in milk and milk-containing foods. People with lactose intolerance who ingest lactose-containing
foods may experience painful and embarrassing digestive symptoms.
Lactose
intolerance is a widespread condition affecting over one billion people worldwide and over 40 million people in the United
States (or 15% of the U.S. population), with an estimated nine million of those individuals demonstrating moderate to
severe symptoms [NIH Consensus Statement, LIH, Vol. 27, #2 (February 2010); Objective Insights, “Market Research
Analysis and Forecasts on Lactose Intolerance and RP-G28,” p. 4 and 7 (June 2012)].
In
the United States alone, we believe lactose intolerance is a large and underserved market. Current annual spending on
over-the-counter lactose intolerance aids in the United States has been estimated at approximately $2.45 billion [Zpryme
Research & Consulting, “The Digestive Health Prescription Drug Market,” (May 2009)]. However, these
options are limited and there is no long-term treatment available.
The
most common therapeutic approach is dairy avoidance, which physicians recommend to the majority of their patients. However,
dairy avoidance may lead to inadequate calcium and vitamin D intake, which can predispose individuals to decreased bone
accrual, osteoporosis, and other adverse health outcomes. The 2010 National Institutes of Health conference on lactose
intolerance highlighted the long-term consequences of dairy avoidance demonstrating both the importance of treating the
condition and the need to find improved solutions for patients.
Our
Leading Product Candidate — RP-G28
We
completed a double-blinded, randomized, multi-center, placebo-controlled Phase 2a clinical study of RP-G28. The purpose
of the study was to assess the effectiveness, safety and tolerability of RP-G28 compared to a placebo when administered
to subjects with symptoms associated with lactose intolerance.
An
additional goal was to establish proof-of-concept that treatment with RP-G28 facilitates improved lactose metabolism via
the adaptation of intestinal bacteria metabolism (i.e., colonic adaptation). The study evaluated RP-G28 in 62 patients
with lactose intolerance over a treatment period of 35 consecutive days. Post-treatment, subjects reintroduced dairy into
their diets and were followed for an additional 30 days. The results of our Phase 2a study were published in Nutrition
Journal in a manuscript entitled, “Improving lactose digestion and symptoms of lactose intolerance with a novel
galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial.”
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Key
findings of the Phase 2a study include: |
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RP-G28
was well tolerated, with no significant adverse events reported. |
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The
combined data suggest that RP-G28 exerted a positive therapeutic effect and clinically meaningful benefits to patients on
treatment, though not all results were statistically significant. |
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Positive
trends were seen when the entire per protocol study population was analyzed, including some statistically significant subgroup
analysis. |
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Treated
subjects reported increased tolerance to lactose and dairy foods: reduced lactose intolerance symptoms (gas, bloating, cramping
and abdominal pain) were reported in subjects on RP-G28, a durable reduction in abdominal pain (p=0.019) was reported, and
treated patients were 6 times more likely to describe themselves as lactose tolerant (p=0.039). We believe these results are
signals of a clinically meaningful benefit to patients treated with RP-G28. P-value is a conventional statistical method for
measuring the statistical significance of clinical results. In clinical trials, the “p-value” is the probability
that the result was obtained by chance. By convention, a “p-value” that is less than 0.05 is considered statistically
significant. |
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Principal
Component Analysis (PCA), a multivariate method that helps transform a number of possibly correlated variables into a smaller
number of uncorrelated variables called principal components, thereby reducing the dimensions of a complex dataset, also showed
statistically significant shifts in the microbiome of subjects fed RP-G28, compared to placebo, at 66 days. |
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In
sum, positive trends were seen when the entire per protocol study population was analyzed,
including some statistically significant subgroup analysis. We believe these positive
trends along with the benign safety profile seen in the Phase 2a study support continued
drug development of RP-G28. We held a Type C meeting with the FDA’s Division of
Gastroenterology and Inborn Errors Products on February 20, 2013. The purpose of the
meeting was to obtain the FDA’s feedback on the planned Phase 2 program and Phase
3 programs, inform the FDA of our ongoing development plans, gain feedback on relevant
clinical trial design and end points related to patient meaningful benefits, and to inform
the FDA of the status of our product characterization. We believe that this meeting was
a significant step forward in streamlining the pathway to initial U.S. approval of RP-G28
to reduce symptoms and frequency of symptomatic episodes associated with lactose intolerance.
Following
analysis of the Phase 2a clinical trial, discussions with the FDA about the clinical development plan, and further discussions
with our regulatory consultants, we intend to conduct our planned Phase 2b clinical trial as an adaptive design Phase
2b/3 clinical trial. A trial that is designed as an adaptive seamless clinical trial refers to a trial that combines the
objectives of what are typically separate trials into a single uninterrupted trial with multiple objectives. We believe
this trial could serve as one of two pivotal trials should the resulting data and the FDA be supportive of this trial
as a pivotal trial. Neither the FDA nor any other comparable governmental agency has considered the Phase 2b/3 study or
our current development plan for RP-G28, and we do not intend to request a meeting with the FDA to discuss these matters.
Regulatory authorities in the United States and Europe have both published guidance documents on the use and implementation
of adaptive design trials. In addition, the regulations governing INDs are extensive and involve numerous notification
requirements including that, generally, an IND supplement must be submitted to and cleared by the FDA before a sponsor
or an investigator may make any change to the investigational plan that may affect its scientific soundness or the rights,
safety or welfare of human subjects. We intend to comply with these requirements. We believe we will need to submit an
IND supplement containing amended protocols for a Phase 2b/3 adaptive trial to FDA for review. These amended protocols
must also be approved by the IRB with responsibility for review and approval of the Phase 2b/3 study.
The
Phase 2b/3 clinical trial that we intend to conduct is being designed as a multi-center double-blinded, placebo controlled
clinical trial of approximately 300 subjects to determine the maximum tolerated dose and optimal dose-escalation schedule
for RP-G28. The trial is going to assess patients with moderate to severe abdominal pain as measured by a pain Likert
scale after a lactose challenge, in which lactose intolerance symptoms and hydrogen production via hydrogen breath test
will be assessed for five hours post-lactose dose, as well as several additional secondary endpoints.
We
have not consulted with the FDA about our intent to use abdominal pain as a primary endpoint for the Phase 2b/3 pivotal
clinical trial. During our Type C Meeting with the FDA in February 2013, we had proposed that future studies with RP-G28
in subjects with lactose intolerance would utilize a total lactose intolerance symptom score, measured by a patient reporting
instrument that we were going to develop, as the primary, stand-alone endpoint. However, based on RP-G28’s mechanism
of action, data from the Phase 2a clinical study, further research conducted after the Type C Meeting in 2013 along with
FDA guidance and products under the review of the Division of Gastroenterology and Inborn Errors Products, we subsequently
decided to use abdominal pain as the primary endpoint for a Phase 2b/Phase 3 study. We believe that evaluation of abdominal
pain is a reliable clinical assessment of treatment response and treatment benefit in a lactose intolerant patient.
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Our
Competitive Strengths
Market
Opportunity
RP-G28
has the potential to become the first approved drug in the United States and Europe for the reduction of symptoms associated
with lactose intolerance.
Renowned
Scientific Team and Management Team
Our
leadership team has extensive biotechnology/pharmaceutical expertise in discovering, developing, licensing and commercializing
therapeutic products. We have attracted a scientific team comprised of innovative researchers who are renowned in their
knowledge and understanding of the host-microbiome in the field of lactose intolerance and gastroenterology.
Substantial
Patent Portfolio and Product Exclusivity
We
have an issued patent in the United Kingdom directed to compositions of non-digestible carbohydrates, and we have issued
patents in the United States directed to methods of using such compositions for the treatment of lactose intolerance and
symptoms. Additional worldwide patent applications are pending. The patent applications include claims covering compositions,
methods, formulations and packaging.
In
addition, in July 2015 we acquired the rights, title and interest to certain patents and related patent applications with
claims covering a process for producing ultra high purity galacto-oligosaccharide active pharmaceutical ingredients, including
RP-G28, from our supplier. See “Business—Clinical Supply and Cooperation Agreement with Ricerche Sperimentali
Montale and Inalco SpA” for additional details regarding the second amendment to the exclusive supply agreement
and our exercise of the exclusive option.
Our
Growth Strategy
In
order to achieve our objective of developing safe and effective applications to treat conditions associated with microbiome
dysfunctions, our near-term and long-term strategies include the following:
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complete
an adaptive design Phase 2b/3 clinical trial and any additional pivotal studies of RP-G28 for the reduction of symptoms associated
with lactose intolerance; |
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seek
regulatory approval of RP-G28 for the reduction of symptoms associated with lactose intolerance if the clinical trials are
successful, initially in the United States and subsequently in the rest of the world; |
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develop
and commercialize RP-G28 either by ourselves or in collaboration with others throughout the world; |
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explore
the use of RP-G28 for additional potential therapeutic indications and orphan indications; |
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establish
the Company as a leader in developing therapeutics that modulate the human gut microbiome; |
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continue
to develop a robust and defensible patent portfolio, including patents we own and those we plan to in-license in the future;
and |
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continue
to optimize our product development and manufacturing capabilities both internally and through outside manufacturers. |
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Risks
Relating to Our Business
We
are an early stage pharmaceutical company, and our business and ability to execute our business strategy are subject to
a number of risks of which you should be aware before you decide to buy our common stock. In particular, you should consider
the risks discussed in the “Risk Factors” section of this prospectus, including, but not limited to, the following:
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We
have incurred net losses in each year since our inception. We expect to incur net losses and negative operating cash flow
for the foreseeable future, and may never achieve or maintain profitability. |
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We
will require substantial additional funding to complete the development and commercialization
of RP-G28 and to fund our operations generally and such funding may not be available
on acceptable terms or at all. |
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We
are substantially dependent on the success of our only product candidate, RP-G28, which is under clinical development. We
cannot be certain that RP-G28 will receive regulatory approval or be successfully commercialized even if we receive regulatory
approval. |
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Future
clinical trials of RP-G28, or other product candidates, may not be successful. If we are unable to obtain required marketing
approvals for, commercialize, obtain and maintain patent protection for or gain sufficient market acceptance by physicians,
patients and healthcare payers of RP-G28, or other product candidates, or experience significant delays in doing so, our business
will be materially harmed and our ability to generate revenue will be materially impaired. |
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RP-G28
and any other product candidates we may develop in the future will be subject to ongoing regulatory requirements and any violations
of these requirements could negatively affect our business and results of operation. |
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Any
delay or disruption in the manufacture and supply of RP-G28 (including delays related to required regulatory approvals) may
negatively impact our operations. |
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We
will be substantially dependent on third-party manufacturers to manufacture our products and key ingredients in sufficient
quantities and on a timely basis, while complying with extensive FDA and European Medicines Agency, or EMA, requirements.
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We
may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants. |
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If
we are unable to maintain valid and enforceable intellectual property rights or if our intellectual property rights are inadequate
for RP-G28 and our product candidates, our competitive position could be harmed. |
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We
could face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail
to compete effectively. |
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Implications
of Being an Emerging Growth Company
We
qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012. As
an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise
applicable generally to public companies. See “Risk Factors — Risks Relating to Our Common Stock
and this Offering — We are an ‘emerging growth company’ and will be able to avail ourselves
of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock less attractive
to investors.” These provisions include:
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being
permitted to provide only two years of audited financial statements in addition to any required unaudited interim financial
statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” disclosure; |
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reduced
disclosure obligations regarding executive compensation arrangements; |
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not
being required to hold a non-binding advisory vote on executive compensation or golden parachute arrangements; and |
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exemption
from the auditor attestation requirement in the assessment of our internal control over financial reporting. |
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We
have elected to use the extended transition period for complying with new or revised
accounting standards under Section 102(b)(1) of the JOBS Act. This election allows us
to delay the adoption of new or revised accounting standards that have different effective
dates for public and private companies until those standards apply to private companies.
As a result of this election, our financial statements may not be comparable to companies
that comply with public company effective dates.
We
will remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following
the fifth anniversary of the date we completed our initial public offering, which was June 29, 2015, (b) in which we have
total annual gross revenue of at least $1.0 billion, or (c) in which we are deemed to be a large accelerated filer, which
means the market value of our common stock that is held by non-affiliates exceeded $700.0 million as of the prior June
30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior
three-year period. We may choose to take advantage of some but not all of these exemptions. We have taken advantage of
reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different than
the information you receive from other public companies in which you hold stock.
We
refer to the Jumpstart Our Business Startups Act of 2012 in this prospectus as the “JOBS Act,” and references
in this prospectus to “emerging growth company” have the meaning associated with that term as used in the
JOBS Act.
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Notwithstanding
the above, we are also currently a “smaller reporting company” meaning that we are not an investment company,
an asset-backed issuer, or a majority-owned subsidiary of a parent company that is not a smaller reporting company and
have a public float of less than $75 million and annual revenues of less than $50 million during the most recently completed
fiscal year. In the event that we are still considered a smaller reporting company at such time as we cease to be an emerging
growth company, the disclosure we will be required to provide in our filings with the Securities and Exchange Commission,
or SEC, will increase, but will still be less than it would be if we were not considered either an emerging growth company
or a smaller reporting company. Specifically, similar to emerging growth companies, smaller reporting companies are able
to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b)
of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) requiring that independent registered public
accounting firms provide an attestation report on the effectiveness of their internal control over financial reporting;
and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being
required to provide two years of audited financial statements in their annual reports.
Corporate
Information
We
were formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC. On September
16, 2008, we converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc. Our principal executive
offices are located at 1880 Century Park East, #1000, Los Angeles, CA 90067, and our telephone number is (310) 203-1000.
Our website address is www.ritterpharmaceuticals.com. The information contained on, or that can be accessed through,
our website is not part of this prospectus.
We
previously marketed a product under the Lactagen trademark. This prospectus may contain references to our trademark and
to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus,
including logos, artwork and other visual displays, may appear without the ® or TM symbols,
but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable
law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use
or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship
of us by, any other company.
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Common
Stock being Offered by the Selling Stockholder |
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1,577,699
shares. |
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Common
Stock Outstanding |
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8,582,009
shares
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Common
Stock Outstanding After the Offering |
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9,470,844
shares |
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Use
of Proceeds |
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The
selling stockholder will receive all of the proceeds from the sale of the shares offered for sale by it under this prospectus.
We will not receive proceeds from the sale of the shares by the selling stockholder. However, we have received proceeds of
$1.0 million, and may receive up to $9.0 million additional proceeds, for an aggregate of $10.0 million from the sale of our
common stock to the selling stockholder under the common stock purchase agreement described below. Any proceeds from the selling
stockholder that we receive under the purchase agreement are expected be used for working capital and general corporate purposes,
including research and development activities. |
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NASDAQ
Capital Market Symbol |
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RTTR |
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Risk
Factors |
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Investing
in our securities involves a high degree of risk. You should carefully review and consider the “Risk Factors”
section of this prospectus for a discussion of factors to consider before deciding to invest in shares of our common stock. |
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The
number of shares of our common stock to be outstanding following this offering is based on an aggregate of 8,582,009 shares outstanding
as of December 30, 2015 and includes the 500,000 Initial Purchase Shares and 188,864 Commitment Shares described below, but excludes:
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1,904,532
shares of common stock issuable upon exercise of outstanding options as of December 30, 2015, at a weighted average exercise
price of $2.73 per share, of which 659,975 shares are vested as of such date; |
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206,448
shares of common stock reserved for future issuance under the 2015 Equity Incentive Plan; and |
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578,321
shares of common stock issuable upon exercise of warrants outstanding as of December 30, 2015. |
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The
information in this prospectus gives effect to the 1-for-7.15 reverse stock split of our common stock which was effected
on June 17, 2015.
Common
Stock Issued and Issuable to the Selling Stockholder
On
December 18, 2015, we entered into a common stock purchase agreement, or the Purchase Agreement, with Aspire Capital Fund,
LLC, an Illinois limited liability company, or Aspire Capital or the selling stockholder, which provides that, upon the
terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an
aggregate of $10.0 million of our shares of common stock over the approximately 30-month term of the Purchase Agreement.
In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement,
we issued to Aspire Capital 188,864 shares of our common stock as a commitment fee, or the Commitment Shares. Upon execution
of the Purchase Agreement, the Company agreed to sell to Aspire Capital 500,000 shares of common stock, or the Initial
Purchase Shares, at $2.00 per share for proceeds of $1.0 million. Concurrently with entering into the Purchase
Agreement, we also entered into a registration rights agreement with Aspire Capital, or the Registration Rights Agreement,
in which we agreed to file one or more registration statements, including the registration statement of which this prospectus
is a part, as permissible and necessary to register under the Securities Act of 1933, as amended, or the Securities Act,
the sale of the shares of our common stock that have been and may be issued to Aspire Capital under the Purchase Agreement.
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As
of December 30, 2015 there were 8,582,009 shares of our common stock outstanding (of
which 5,317,454 shares were held by non-affiliates including Aspire Capital) which includes
the 500,000 Initial Purchase Shares and the 188,864 Commitment Shares that have already
been issued to Aspire Capital, but excludes the 888,835 shares of common stock that we
may issue to Aspire Capital after this registration statement is declared effective under
the Securities Act. If all of such 1,577,699 shares of our common stock offered hereby
were issued and outstanding as of the date hereof, such shares would represent 16.7%
of the total common stock outstanding or 25.4% of the non-affiliate shares of common
stock outstanding as of December 30, 2015.
The
aggregate number of shares that we may issue to Aspire Capital under the Purchase Agreement may in no case exceed 1,577,699
shares of our common stock (which is equal to approximately 19.99% of the common stock outstanding on the date of the
Purchase Agreement), unless (i) stockholder approval is obtained to issue more, in which case this 1,577,699 share limitation
will not apply, or (ii) stockholder approval has not been obtained and at any time the 1,577,699 share limitation is reached
and at all times thereafter the average price paid for all shares issued under the Purchase Agreement (including the Commitment
Shares and the Initial Purchase Shares) is equal to or greater than $1.75, the Minimum Price, a price equal to the closing
sale price of our common stock on the business date of the execution of the Purchase Agreement; provided that at no point
in time shall Aspire Capital (together with its affiliates) beneficially own more than 19.99% of our common stock.
Pursuant
to the Purchase Agreement and the Registration Rights Agreement, we are registering 1,577,699 shares of our common stock
under the Securities Act, which includes the Commitment Shares and the Initial Purchase Shares that have already been
issued to Aspire Capital, and 888,835 shares of common stock which we may issue to Aspire Capital after this registration
statement is declared effective under the Securities Act. All 1,577,699 shares of common stock are being offered pursuant
to this prospectus.
After
the SEC has declared effective the registration statement of which this prospectus is a part, on any trading day on which
the closing sale price of our common stock exceeds $0.50, we have the right, in our sole discretion, to present Aspire
Capital with a purchase notice, or each a Purchase Notice, directing Aspire Capital (as principal) to purchase up to 100,000
shares of our common stock per trading day, up to $9.0 million of our common stock in the aggregate at a per share price,
or the Purchase Price, calculated by reference to the prevailing market price of our common stock (as more specifically
described below).
In
addition, on any date on which we submit a Purchase Notice for 100,000 shares to Aspire Capital and the closing sale price
of our stock is equal to or greater than $0.50 per share of Common Stock , we also have the right, in our sole discretion,
to present Aspire Capital with a volume-weighted average price purchase notice, or each a VWAP Purchase Notice, directing
Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common
stock traded on the Nasdaq Capital Market on the next trading day, or the VWAP Purchase Date, subject to a maximum number
of shares we may determine, or the VWAP Purchase Share Volume Maximum, and a minimum trading price, or the VWAP Minimum
Price Threshold (as more specifically described below). The purchase price per Purchase Share pursuant to such VWAP Purchase
Notice, or the VWAP Purchase Price, is calculated by reference to the prevailing market price of our common stock (as
more specifically described below).
The
Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement
on any purchase date where the closing sale price of our common stock is less than $0.50 per share, or the Floor Price.
This Floor Price and the respective prices and share numbers in the preceding paragraphs will be appropriately adjusted
for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction.
There are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing
and amount of any sales of our common stock to Aspire Capital. Aspire Capital has no right to require any sales by us,
but is obligated to make purchases from us as we direct in accordance with the Purchase Agreement. There are no limitations
on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation
rights, penalties or liquidated damages in the Purchase Agreement. Aspire Capital may not assign its rights or obligations
under the Purchase Agreement. The Purchase Agreement may be terminated by us at any time, at our discretion, without any
penalty or cost to us.
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RISK
FACTORS
Investing
in our common stock involves a high degree of risk. You should carefully consider the following risk factors, as well as the other
information in this prospectus, including our financial statements and related notes, before deciding whether to invest in shares
of our common stock. The occurrence of any of the adverse developments described in the following risk factors could materially
and adversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our
common stock could decline, and you may lose all or part of your investment.
Risks
Relating to Our Financial Position and Need for Additional Capital
We
have incurred net losses in each year since our inception. Currently, we have no products approved for commercial sale. As a result,
our ability to reduce our losses and reach profitability is unknown, and we may never achieve or sustain profitability.
We
have incurred net losses in each year since our inception. The accompanying financial statements have been prepared assuming that
we will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities
in the normal course of business. For the years ended December 31, 2014 and 2013, we had net losses of approximately $2.5 million
and $2.1 million, respectively, and had net cash used in operating activities of approximately $1.2 million and $2.0 million,
respectively. For the nine months ended September 30, 2015 and 2014, we had net losses of approximately $6.6 million and $944,000,
respectively, and had net cash used in operating activities of approximately $4.3 million and $887,000, respectively.
To
date, we have devoted most of our financial resources to our corporate overhead and research and development, including our drug
discovery research, preclinical development activities and clinical trials. We currently have no products that are approved for
commercial sale. We expect to continue to incur net losses and negative operating cash flow for the foreseeable future, and we
expect these losses to increase as we continue our development of, and seek regulatory approvals for, RP-G28, and other product
candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support
our product development efforts and operations as a public company. We anticipate that any such losses could be significant for
the next several years as we begin our Phase 2b/3 and any Phase 3 clinical trials for RP-G28 for the reduction of symptoms associated
with lactose intolerance and related activities required for regulatory approval of RP-G28. If RP-G28 or any of our other product
candidates fails in clinical trials or does not gain regulatory approval, or if our product candidates do not achieve market acceptance,
we may never become profitable. These net losses and negative cash flows have had, and will continue to have, an adverse effect
on our stockholders’ equity and working capital.
Because
of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict
the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses
could increase if we are required by the FDA or the EMA, to perform studies or trials in addition to those currently expected,
or if there are any delays in completing our clinical trials or the development of our product candidates. The amount of future
net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.
We
will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available,
may require us to delay, limit, reduce or cease our operations.
We
are currently advancing RP-G28 through clinical development. Developing pharmaceutical products, including conducting preclinical
studies and clinical trials, is expensive. As of September 30, 2015, we have a total of approximately $16.2 million in cash.
On
June 29, 2015, we closed our initial public offering of 4,000,000 shares of common stock at a public offering price of $5.00 per
share. Total gross proceeds from our initial public offering were $20.0 million before deducting underwriting discounts and commissions
and other offering expenses payable by us, resulting in net proceeds of $17.4 million. We expect our existing cash and cash equivalents,
together with interest, and the net proceeds from our sale of shares to Aspire Capital pursuant to the Purchase Agreement will
be sufficient to fund our current operations through the first quarter of 2017. However, this period could be shortened if there
are any significant increases in planned spending on development programs or more rapid progress of development programs than
anticipated. For example, our clinical trials may encounter technical, enrollment or other difficulties that could increase our
development costs more than we expect.
We
do not expect our existing capital resources will be sufficient to enable us to complete the commercialization of RP-G28, if approved,
or to initiate any clinical trials or additional development work for other product candidates, other than as described above.
We will need to secure additional financing in order to complete clinical development and commercialize RP-G28 and to generally
fund our operations. To complete the work necessary to file a new drug application, or NDA, and a Marketing Authorization Application,
or MAA, for RP-G28 as a treatment for patients with lactose intolerance, which is currently anticipated to occur in 2019, we estimate
that our RP-G28 clinical trials, and our planned clinical and nonclinical studies, as well as other work needed to submit RP-G28
for regulatory approval in the United States, Europe and other countries, will cost approximately $85 million, including the internal
resources needed to manage the program. If the FDA or EMA requires that we perform additional nonclinical studies or clinical
trials, our expenses would further increase beyond what we currently expect and the anticipated timing of any potential NDA or
MAA would likely be delayed.
If
we are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or
development programs. We also could be required to seek funds through arrangements with collaborative partners or otherwise that
may require us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable
to us.
The
extent to which we utilize the Purchase Agreement with Aspire Capital as a source of funding will depend on a number of factors,
including the prevailing market price of our common stock, the volume of trading in our common stock and the extent to which we
are able to secure funds from other sources. The number of shares that we may sell to Aspire Capital under the Purchase Agreement
on any given day and during the term of the agreement is limited. See “The Aspire Capital Transaction” section of
this prospectus for additional information. Additionally, we and Aspire Capital may not effect any sales of shares of our common
stock under the Purchase Agreement during the continuance of an event of default or on any trading day that the closing sale price
of our common stock is less than $0.50 per share. Even if we are able to access the full $10.0 million under the Purchase Agreement,
we will still need additional capital to fully implement our business, operating and development plans.
We
may sell additional equity or debt securities to fund our operations, which would result in dilution to our stockholders and imposed
restrictions on our business.
We
may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding,
commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.
Additional funding may not be available to us on acceptable terms or at all. To the extent that the Company raises additional
funds by issuing equity securities, the Company’s stockholders may experience significant dilution. Any debt financing,
if available, may involve restrictive covenants that impact the Company’s ability to conduct business. If the Company is
not able to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly delay, scale
back or discontinue the development and/or commercialization of one or more product candidates; (ii) seek collaborators for product
candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be
available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that the Company
would otherwise seek to develop or commercialize. In addition, the terms of any financing may adversely affect the holdings or
the rights of our stockholders and the issuance of additional shares by us, or the possibility of such issuance, may cause the
market price of our shares to decline.
Our
financial condition and operating results have varied significantly since our formation and are expected to continue to fluctuate
significantly from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control.
Our
operations since 2010 have been limited to developing our technology and undertaking preclinical studies and clinical trials of
our lead product candidate, RP-G28. We have not yet obtained regulatory approvals for RP-G28, or any other product candidate.
Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had approved
products on the market. Our financial condition and operating results have varied significantly since our formation and are expected
to continue to significantly fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are
beyond our control. Factors relating to our business that may contribute to these fluctuations include:
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any
delays in regulatory review and approval of our product candidates in clinical development, including our ability to receive
approval from the FDA and the EMA for RP-G28 for the reduction of symptoms associated with lactose intolerance in patients
based on our Phase 2b/3 and any Phase 3 trials of RP-G28, and our other completed and planned clinical and nonclinical studies
and other work, as the basis for review and approval of RP-G28 for the reduction of symptoms associated with lactose intolerance
in patients; |
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delays
in the commencement, enrollment and timing of clinical trials; |
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difficulties
in identifying and treating patients suffering from our target indications; |
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the
success of our clinical trials through all phases of clinical development, including our Phase 2b/3 and any Phase 3 trials
of RP-G28 for the reduction of symptoms associated with lactose intolerance in patients; |
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potential
side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the
market; |
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our
ability to obtain additional funding to develop our product candidates; |
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our
ability to identify and develop additional product candidates; |
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market
acceptance of our product candidates; |
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our
ability to establish an effective sales and marketing infrastructure directly or through collaborations with third parties;
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competition
from existing products or new products that may emerge; |
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the
ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products; |
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our
ability to adhere to clinical study requirements directly or with third parties such as contract research organizations, or
CROs; |
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our
dependency on third-party manufacturers to manufacture our products and key ingredients; |
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our
ability to establish or maintain collaborations, licensing or other arrangements; |
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the
costs to us, and our ability and our third-party collaborators’ ability to obtain, maintain and protect our intellectual
property rights; |
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costs
related to and outcomes of potential intellectual property litigation; |
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our
ability to adequately support future growth; |
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our
ability to attract and retain key personnel to manage our business effectively; and |
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potential
product liability claims. |
Accordingly,
the results of any quarterly or annual periods should not be relied upon as indications of future operating performance.
Risks
Relating to Regulatory Review and Approval of Our Product Candidates
We
are substantially dependent on the success of our current product candidate, RP-G28.
We
currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. We currently
invest nearly all of our efforts and financial resources in the research and development of RP-G28, which is currently our only
product candidate. Our business currently depends entirely on the successful development and commercialization of RP-G28.
We
cannot be certain that RP-G28 will receive regulatory approval, and without regulatory approval we will not be able to market
RP-G28 as a prescription drug.
The
development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the
FDA in the United States, the EMA in Europe, and regulatory authorities in other countries, with regulations differing from country
to country. We are not permitted to market our product candidates in the United States or Europe until we receive approval of
a NDA from the FDA or a MAA from the EMA, respectively. We have not submitted any marketing applications for RP-G28.
NDAs
and MAAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s
safety and effectiveness for each desired indication. NDAs and MAAs must also include significant information regarding the chemistry,
manufacturing and controls for the product. Obtaining approval of a NDA or a MAA is a lengthy, expensive and uncertain process,
and we may not be successful in obtaining approval. The FDA and the EMA review processes can take years to complete and approval
is never guaranteed. If we submit a NDA to the FDA, the FDA must decide whether to accept or reject the submission for filing.
We cannot be certain that any submissions will be accepted for filing and review by the FDA. Regulators of other jurisdictions,
such as the EMA, have their own procedures for approval of product candidates. Even if a product is approved, the FDA or the EMA,
as the case may be, may limit the indications for which the product may be marketed, require extensive warnings on the product
labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval. Regulatory authorities
in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must
comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country
does not ensure that we will be able to obtain regulatory approval in any other country. In addition, delays in approvals or rejections
of marketing applications in the United States, Europe or other countries may be based upon many factors, including regulatory
requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory questions regarding different
interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of
new information regarding our product candidates or other products. Also, regulatory approval for any of our product candidates
may be withdrawn.
We
have completed one Phase 2a trial for RP-G28. Before we submit a NDA to the FDA or a MAA to the EMA for RP-G28 for the treatment
of pain and the reduction in the frequency of symptomatic episodes of lactose intolerance, we must successfully complete a Phase
2b/3 trial and Phase 3 trials. Following analysis of the Phase 2a clinical trial, discussions with the FDA during the Type C meeting
in 2013 about our clinical development plan, and further discussions with our regulatory consultants, we intend to conduct our
planned Phase 2b clinical trial as an adaptive design Phase 2b/3 clinical trial. A trial that is designed as an adaptive seamless
clinical trial refers to a trial that combines the objectives of what are typically separate trials into a single uninterrupted
trial with multiple objectives.
Neither
the FDA nor any other comparable governmental agency has considered this Phase 2b/3 study or our current development plan for
RP-G28, and we do not intend to request a meeting with the FDA to discuss these matters. Regulatory authorities in the United
States and Europe have both published guidance documents on the use and implementation of adaptive design trials. These documents
include description of adaptive trials and include a requirement for prospectively written standard operating procedures and working
processes for executing adaptive trials and a recommendation that sponsor companies engage with CROs that have the necessary experience
in running such trials. In addition, the regulations governing INDs are extensive and involve numerous notification requirements
including that, generally, an IND supplement must be submitted to and cleared by the FDA before a sponsor or an investigator may
make any change to the investigational plan that may affect its scientific soundness or the rights, safety or welfare of human
subjects. We intend to comply with these requirements and believe we will need to submit an IND supplement containing amended
protocols for the Phase 2b/3 adaptive trial. There can be no assurance that the FDA will provide clearance for an amended IND
for a Phase 2b/3 trial in a timely manner, if at all, and that this trial and other trials will not be delayed or disrupted as
a result.
In
addition, guidelines adopted by the FDA and established by the International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) require nonclinical studies that specifically address female fertility
to be completed before the inclusion of women of child bearing potential in large-scale or long-duration clinical trials (e.g.,
Phase 3 trials). In the United States, such assessments of embryo-fetal development can be deferred until before Phase 3 using
precautions to prevent pregnancy in clinical trials. As the FDA recommended in their June 28, 2010 advice letter, we will continue
to evaluate females of child-bearing potential who are willing to use appropriate contraception throughout the duration of any
study. To support any Phase 3 study, we plan to perform ICH-compliant embryo-fetal developmental toxicology studies (in two species)
and the ICH-recommended standard battery of genotoxicity tests using RP-G28. We also intend to perform work on the characterization
of compounds and analytical specifications for RP-G28. The design of our Phase 2b/3 trial will need to account for these FDA and
ICH requirements, and we may need to complete all nonclinical studies that specifically address female fertility before we complete
a Phase 2b/3 clinical trial. We cannot predict whether our future trials and studies will be successful or whether regulators
will agree with our conclusions regarding the preclinical studies and clinical trials we have conducted to date.
If
we are unable to obtain approval from the FDA, the EMA or other regulatory agencies for RP-G28, or if, subsequent to approval,
we are unable to successfully commercialize RP-G28, we will not be able to generate sufficient revenue to become profitable or
to continue our operations.
Any
statements in this document indicating that RP-G28 has demonstrated preliminary evidence of efficacy are our own and are not based
on the FDA’s or any other comparable governmental agency’s assessment of RP-G28 and do not indicate that RP-G28 will
achieve favorable efficacy results in any later stage trials or that the FDA or any comparable agency will ultimately determine
that RP-G28 is effective for purposes of granting marketing approval.
The
FDA and other regulatory agencies outside the United States, such as the EMA, may not agree to our proposed endpoint for approval
of RP-G28 for the reduction of symptoms associated with lactose intolerance in patients, in which case we would need to complete
an additional clinical trial in order to seek approval outside the United States.
During
our Type C Meeting with the FDA in February 2013, we had proposed that future studies with RP-G28 in subjects with lactose intolerance
would utilize a total lactose intolerance symptom score, measured by a patient reporting instrument that we were going to develop,
as the primary, stand-alone endpoint. However, based on RP-G28’s mechanism of action, data from the Phase 2a clinical study,
further research conducted after the Type C Meeting with the FDA along with FDA guidance and products under the review of the
Division of Gastroenterology and Inborn Errors Products, we now intend to use abdominal pain, measured by an 11-point validated
scale, as the primary endpoint for the Phase 2b/Phase 3 study that assesses RP-G28 for the management of lactose intolerant patients
with moderate to severe abdominal pain associated with lactose intake. We believe that evaluation of abdominal pain is a reliable
clinical assessment of treatment response and treatment benefit in a lactose intolerant patient. Although no FDA-approved product
exists for lactose intolerance, the use of a pain scale as a primary endpoint has been used as a validated primary measurement
in many approved products, including other gastrointestinal products used to treat diseases such as Irritable Bowel Syndrome (IBS).
We have not consulted with the FDA about our intent to use abdominal pain as a primary endpoint or our plan to convert our Phase
2b clinical trial into an adaptive design Phase 2b/3 pivotal clinical trial.
We
do not know if the FDA, the EMA or regulatory authorities in other countries will agree with our final primary endpoint for approval
of RP-G28. The FDA, the EMA and regulatory authorities in other countries in which we may seek approval for and market RP-G28,
may require additional nonclinical studies and/or clinical trials prior to granting approval. It may be expensive and time consuming
to conduct and complete additional nonclinical studies and clinical trials that the EMA and other regulatory authorities may require
us to perform. As such, any requirement by the EMA or other regulatory authorities that we conduct additional nonclinical studies
or clinical trials could materially and adversely affect our business, financial condition and results of operations. Furthermore,
even if we receive regulatory approval of RP-G28 for the reduction of symptoms associated with lactose intolerance in patients,
the labeling for RP-G28 in the United States, Europe or other countries in which we seek approval may include limitations that
could impact the commercial success of RP-G28.
The
results from our planned Phase 2b/3 trial with adaptive design may not be sufficiently robust to support the submission of marketing
approval for RP-G28.
We
intend to conduct our planned Phase 2b clinical trial as an adaptive design seamless Phase 2b/3 clinical trial. We do not intend
to meet with the FDA to discuss the Phase 2b/3 study design or current development plan for RP-G28. The FDA standard for traditional
approval of a drug generally requires two well-controlled Phase 3 studies. If the FDA disagrees with our choice of primary endpoint
for our Phase 2b/3 trial or the results for the primary endpoint are not robust or significant relative to control, are subject
to confounding factors, or are not adequately supported by other study endpoints, the FDA may not recognize the Phase 2b/3 trial
as one of the required pivotal trials required for FDA approval. If the FDA or other regulatory authorities do not recognize this
trial as a pivotal trial, we would incur increased costs and delays in the marketing approval process, which would require us
to expend more resources than we have available.
Delays
in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our
ability to obtain regulatory approval for RP-G28 or our other product candidates.
Delays
in the commencement, enrollment and completion of clinical trials could increase our product development costs or limit the regulatory
approval of RP-G28 or other product candidates we may develop in the future. Although we believe that our existing cash and cash
equivalents, together with interest, and the net proceeds from our sale of shares to Aspire Capital pursuant to the Purchase Agreement
should be sufficient to fund our projected operating requirements through the completion of the Phase 2b/3 and any Phase 3 trials
of RP-G28, we may not be able to complete these trials on time or we may be required to conduct additional clinical trials or
nonclinical studies not currently planned to receive approval for RP-G28 as a treatment for lactose intolerance. The commencement,
enrollment and completion of clinical trials may be delayed or suspended for a variety of reasons, including:
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inability
to obtain sufficient funds required for a clinical trial; |
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inability
to reach agreements on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive
negotiation and may vary significantly among different CROs and trial sites; |
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clinical
holds, other regulatory objections to commencing or continuing a clinical trial or the inability to obtain regulatory approval
to commence a clinical trial in countries that require such approvals; |
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discussions
with the FDA or non-U.S. regulators regarding the scope or design of our clinical trials; |
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inability
to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial
programs, including some that may be for the same indications targeted by our product candidates; |
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inability
to obtain approval from institutional review boards, or IRBs, to conduct a clinical trial at their respective sites; |
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severe
or unexpected drug-related adverse effects experienced by patients; |
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inability
to timely manufacture sufficient quantities of the product candidate required for a clinical trial; |
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difficulty
recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including meeting the enrollment
criteria for our study and competition from other clinical trial programs for the same indications as our product candidates;
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inability
to get FDA approval of our end points; and |
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inability
to retain enrolled patients after a clinical trial is underway. |
Changes
in regulatory requirements and guidance may also occur and we may need to amend clinical trial protocols to reflect these changes
with appropriate regulatory authorities. Amendments may require us to resubmit clinical trial protocols to IRBs for re-examination,
which may impact the costs, timing or successful completion of a clinical trial. In addition, a clinical trial may be suspended
or terminated at any time by us, our future collaborators, the FDA or other regulatory authorities due to a number of factors,
including:
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our
failure or the failure of our potential future collaborators to conduct the clinical trial in accordance with regulatory requirements
or our clinical protocols; |
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unforeseen
safety issues or any determination that a clinical trial presents unacceptable health risks; |
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lack
of adequate funding to continue the clinical trial due to unforeseen costs or other business decisions; and |
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a
breach of the terms of any agreement with, or for any other reason by, future collaborators who have responsibility for the
clinical development of our product candidates. |
In
addition, if we or any of our potential future collaborators are required to conduct additional clinical trials or other nonclinical
studies of our product candidates beyond those contemplated, our ability to obtain regulatory approval of these product candidates
and to generate revenue from their sales would be similarly harmed.
Clinical
failure can occur at any stage of clinical development. The results of earlier clinical trials are not necessarily predictive
of future results and any product candidate we or our potential future collaborators advance through clinical trials may not have
favorable results in later clinical trials or receive regulatory approval.
Clinical
failure can occur at any stage of our clinical development. Clinical trials may produce negative or inconclusive results, and
we or our collaborators may decide, or regulators may require us, to conduct additional clinical trials or nonclinical studies.
In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret
our data as favorably as we do, which may delay, limit or prevent regulatory approval. Success in preclinical studies and early
clinical trials does not ensure that subsequent clinical trials will generate the same or similar results or otherwise provide
adequate data to demonstrate the efficacy and safety of a product candidate. A number of companies in the pharmaceutical industry,
including those with greater resources and experience than us, have suffered significant setbacks in Phase 2b and/or Phase 3 clinical
trials, including adaptive seamless clinical trials even after seeing promising results in earlier clinical trials.
In
addition, the design of a clinical trial can determine whether its results will support approval of a product and flaws in the
design of a clinical trial may not become apparent until the clinical trial is well-advanced. We may be unable to design and execute
a clinical trial to support regulatory approval. Further, clinical trials of potential products often reveal that it is not practical
or feasible to continue development efforts.
If
RP-G28, or any of our other product candidates, is found to be unsafe or lack efficacy, we will not be able to obtain regulatory
approval for it and our business would be harmed. For example, if the results of our Phase 2b/3 and any Phase 3 trials of RP-G28
do not achieve the primary efficacy endpoints or demonstrate expected safety, the prospects for approval of RP-G28 would be materially
and adversely affected.
In
some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product
candidate due to numerous factors, including changes in trial protocols, differences in composition of the patient populations,
adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. We do not
know whether any Phase 2, Phase 3 or other clinical trials we or any of our potential future collaborators may conduct will demonstrate
the consistent or adequate efficacy and safety that would be required to obtain regulatory approval and market RP-G28. The adaptive
Phase 2b/3 clinical trial for RP-G28 that we intend to conduct may not be deemed to be a pivotal trial by the FDA or may not provide
sufficient support for NDA approval. The FDA may require us to make changes to the proposed study design for this adaptive trial
or may require us to conduct one or more additional clinical trials, possibly involving a larger sample size or a different clinical
trial design, or may require longer follow-up periods, particularly if the FDA does not find the results from an adaptive Phase
2b/3 clinical trial to be sufficiently persuasive as one of the required pivotal trials required for FDA approval. If we are unable
to bring RP-G28 to market, our ability to create long-term stockholder value will be limited.
Our
product candidates may have undesirable side effects which may delay or prevent marketing approval, or, if approval is received,
require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
Unforeseen
side effects from RP-G28, or other product candidates we may develop in the future, could arise either during clinical development
or, if approved, after the approved product has been marketed. The most common side effects observed in clinical trials of RP-G28
were headache (nine out of 57), nausea (three out of 57), upper respiratory tract infection, nasal congestion, and pain (two out
of 57). No patients were withdrawn from the study for these side effects.
The
results of future clinical trials may show that RP-G28 causes undesirable or unacceptable side effects, which could interrupt,
delay or halt clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory
authorities, or result in marketing approval from the FDA and other regulatory authorities with restrictive label warnings.
If
RP-G28, or any other product candidate we develop in the future, receives marketing approval and we or others later identify undesirable
or unacceptable side effects caused by such product:
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regulatory
authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians
and pharmacies; |
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we
may be required to change instructions regarding the way the product is administered, conduct additional clinical trials or
change the labeling of the product; |
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we
may be subject to limitations on how we may promote the product; |
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sales
of the product may decrease significantly; |
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regulatory
authorities may require us to take our approved product off the market; |
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we
may be subject to litigation or product liability claims; and |
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our
reputation may suffer. |
Any
of these events could prevent us or our potential future collaborators from achieving or maintaining market acceptance of the
affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us
from generating significant revenues from the sale of our products.
Reimbursement
decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement
for our products, it is less likely that they will be widely used.
Market
acceptance and sales of RP-G28, or any other product candidates we develop in the future, if approved, will depend on reimbursement
policies and may be affected by, among other things, future healthcare reform measures. Government authorities and third-party
payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish
payment levels. We cannot be certain that reimbursement will be available for RP-G28 or any other product candidates that we may
develop. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, our products.
If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize RP-G28,
or other product candidates that we develop.
In
the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA, changed the way Medicare
covers and pays for pharmaceutical products. The legislation established Medicare Part D, which expanded Medicare coverage for
outpatient prescription drug purchases by the elderly but provided authority for limiting the number of drugs that will be covered
in any therapeutic class. The MMA also introduced a new reimbursement methodology based on average sales prices for physician-administered
drugs. Any negotiated prices for our products covered by a Part D prescription drug plan will likely be lower than the prices
we might otherwise obtain in the United States. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries,
private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction
in payment that results from the MMA may result in a similar reduction in payments from non-governmental payors.
The
United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory
proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy
makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems
with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States,
the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative
initiatives. We expect to experience pricing pressures in connection with the sale of RP-G28, and any other product candidates
that we develop, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and
additional legislative proposals.
In
March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation
Act, or, collectively, the ACA, became law in the United States. The goal of the ACA is to reduce the cost of health care and
substantially change the way health care is financed by both governmental and private insurers. While we cannot predict what impact
on federal reimbursement policies this legislation will have in general or on our business specifically, the ACA may result in
downward pressure on pharmaceutical reimbursement, which could negatively affect market acceptance of RP-G28 or any other product
candidates that we may develop. In addition, some members of the U.S. Congress have been seeking to overturn at least portions
of the legislation and we expect they will continue to review and assess this legislation and alternative health care reform proposals.
We cannot predict whether new proposals will be made or adopted, when they may be adopted or what impact they may have on us if
they are adopted.
If
we do not obtain protection under the Hatch-Waxman Act and similar legislation outside of the United States by extending the patent
terms and obtaining data exclusivity for our product candidates, our business may be materially harmed.
Depending
upon the timing, duration and specifics of FDA marketing approval of RP-G28, one of our U.S. patents may be eligible for a limited
Patent Term Extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (which is sometimes referred to
as the “Hatch-Waxman Act”), provided our U.S. patent claims a method of treating lactose intolerance that is approved
by the FDA. The Hatch-Waxman Act, 35 U.S.C. §156, permits a patent extension of up to five years as compensation for patent
term lost during the FDA regulatory review process. The scope of protection afforded by the patent during the extended term is
not commensurate with the scope of the unextended portion of the patent; for example, the “rights derived” from a
method of use patent during the extended period are “limited to any use claimed by the patent and approved for the product.”
35 U.S.C. §156(b)(2). We may not be granted an extension because of, for example, failing to apply for the extension within
applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable statutory
and/or regulatory requirements including, for example, the requirement that the patent to be extended “claim” the
approved product or a method of using the approved product. Moreover, the applicable period of extension could be less than we
request. If we are unable to obtain patent term extension or if the term of any such extension is shorter than we request, the
period during which we will be able to exclude others from marketing their versions of our product will be shortened and our competitors
may obtain approval of generic products following our patent expiration, and our revenue could be reduced, possibly materially.
Similar concerns are associated with obtaining Supplemental Protection Certificates (SPCs) of certain patents issued in Europe
and owned by Inalco, to which we have an exclusive options of assignment, based upon patent terms lost during European regulatory
review processes. In the event that we are unable to obtain any patent term extension, the issued patents for RP-G28 are expected
to expire in 2030, assuming they withstand any challenge toothier validity and/or patentability.
If
we market products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws,
we may be subject to civil or criminal penalties.
In
addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare laws,
commonly referred to as “fraud and abuse” laws, have been applied in recent years to restrict certain marketing practices
in the pharmaceutical industry. Other jurisdictions such as Europe have similar laws. These laws include false claims and anti-kickback
statutes. If we market our products and our products are paid for by governmental programs, it is possible that some of our business
activities could be subject to challenge under one or more of these laws.
Federal
false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the
federal government or knowingly making, or causing to be made, a false statement to get a false claim paid. The federal healthcare
program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving
remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare
item or service covered by Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted
to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers or formulary managers
on the other. Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities
from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce
prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Most
states also have statutes or regulations similar to the federal anti-kickback law and federal false claims laws, which apply to
items and services covered by Medicaid and other state programs, or, in several states, apply regardless of the payor. Administrative,
civil and criminal sanctions may be imposed under these federal and state laws.
Over
the past few years, a number of pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety
of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other
monetary benefits to prescribers; reporting inflated average wholesale prices that were then used by federal programs to set reimbursement
rates; engaging in off-label promotion; and submitting inflated best price information to the Medicaid Rebate Program to reduce
liability for Medicaid rebates.
Any
delay or disruption in the manufacture and supply of RP-G28 may negatively impact our operations.
We
do not intend to manufacture the pharmaceutical products that we plan to sell. We currently have agreements with contract manufacturers
for the production of the active pharmaceutical ingredients and the formulation of sufficient quantities of drug product for our
Phase 2b/3 and any Phase 3 trials of RP-G28 and the other trials and nonclinical studies that we believe we will need to conduct
prior to seeking regulatory approval. However, we do not have agreements for commercial supplies of RP-G28 and we may not be able
to reach agreements with these or other contract manufacturers for sufficient supplies to commercialize RP-G28 if it is approved.
Reliance
on third-party manufacturers entails risks, to which we would not be subject if we manufactured the product candidates ourselves,
including:
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the
possibility that we are unable to enter into a manufacturing agreement with a third party to manufacture our product candidates;
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the
possible breach of the manufacturing agreements by the third parties because of factors beyond our control; and |
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the
possibility of termination or nonrenewal of the agreements by the third parties before we are able to arrange for a qualified
replacement third-party manufacturer. |
Any
of these factors could cause the delay of approval or commercialization of our product candidates, cause us to incur higher costs
or prevent us from commercializing our product candidates successfully. Furthermore, if RP-G28 or other product candidates are
approved and contract manufacturers fail to deliver the required commercial quantities of finished product on a timely basis and
at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially
equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand
for our products and could lose potential revenue. It may take several years to establish an alternative source of supply for
our product candidates and to have any such new source approved by the government agencies that regulate our products. In the
event we do need to identify alternative manufacturing partners, we may have to secure licenses to manufacturing and/or purification
technologies, including third-party patent licenses, to allow us to manufacture RP-G28 that is suitable for the late-stage regulatory
review process and/or adequate to manufacture commercial quantities of RP-G28.
If
the FDA and EMA and other regulatory agencies do not approve the manufacturing facilities of our future contract manufacturers
for commercial production, we may not be able to commercialize any of our product candidates.
The
facilities used by any contract manufacturer to manufacture RP-G28, or other product candidates we may develop in the future,
must be the subject of a satisfactory inspection before the FDA or the regulators in other jurisdictions approve the product candidate
manufactured at that facility. We are completely dependent on these third-party manufacturers for compliance with the requirements
of U.S. and non-U.S. regulators for the manufacture of our finished products. If our manufacturers cannot successfully manufacture
material that conform to our specifications and current good manufacturing practice requirements of any governmental agency whose
jurisdiction to which we are subject, our product candidates will not be approved or, if already approved, may be subject to recalls.
Even
if our product candidates receive regulatory approval, we may still face future development and regulatory difficulties.
RP-G28
and any other product candidates we develop in the future, if approved, will be subject to ongoing regulatory requirements for
labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information.
In addition, approved products, manufacturers and manufacturers’ facilities are required to comply with extensive FDA and
EMA requirements and requirements of other similar agencies, including ensuring that quality control and manufacturing procedures
conform to current Good Manufacturing Practices, or cGMPs. As such, we and our contract manufacturers are subject to continual
review and periodic inspections to assess compliance with cGMPs. Accordingly, we and others with whom we work must continue to
expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
We will also be required to report certain adverse reactions and production problems, if any, to the FDA and EMA and other similar
agencies and to comply with certain requirements concerning advertising and promotion for our products. Promotional communications
with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the
information in the product’s approved label. Accordingly, we may not promote our approved products, if any, for indications
or uses for which they are not approved.
If
a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or
frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling
of a product, it may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
If our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:
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issue
warning letters; |
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mandate
modifications to promotional materials or require us to provide corrective information to healthcare practitioners; |
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require
us or our potential future collaborators to enter into a consent decree or permanent injunction, which can include imposition
of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
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impose
other administrative or judicial civil or criminal penalties; |
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withdraw
regulatory approval; |
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refuse
to approve pending applications or supplements to approved applications filed by us or our potential future collaborators;
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impose
restrictions on operations, including costly new manufacturing requirements; or |
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detain,
seize and/or condemn and destroy products. |
Risks
Relating to the Commercialization of Our Products
Even
if approved, our product candidates may not achieve broad market acceptance among physicians, patients and healthcare payors,
and as a result our revenues generated from their sales may be limited.
The
commercial success of RP-G28, if approved, will depend upon its acceptance among the medical community, including physicians,
health care payors and patients. The degree of market acceptance of RP-G28, or other product candidates we may develop in the
future, will depend on a number of factors, including:
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limitations
or warnings contained in our product candidates’ FDA-approved labeling; |
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changes
in the standard of care or availability of alternative therapies at similar or lower costs for the targeted indications for
such product candidates; |
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limitations
in the approved clinical indications for such product candidates; |
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demonstrated
clinical safety and efficacy compared to other products; |
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lack
of significant adverse side effects; |
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sales,
marketing and distribution support; |
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availability
of reimbursement from managed care plans and other third-party payors; |
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timing
of market introduction and perceived effectiveness of competitive products; |
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the
degree of cost-effectiveness; |
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availability
of alternative therapies at similar or lower cost, including generics and over-the-counter products; |
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enforcement
by the FDA and EMA of laws and rulings that prohibit the illegal sale of RP-G28 (or any other product candidate) as a dietary
supplement; |
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the
extent to which our product candidates are approved for inclusion on formularies of hospitals and managed care organizations;
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whether
our product candidates are designated under physician treatment guidelines for the treatment of or reduction of symptoms associated
with the indications for which we have received regulatory approval; |
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adverse
publicity about our product candidates or favorable publicity about competitive products; |
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convenience
and ease of administration of our product candidates; and |
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potential
product liability claims. |
If
our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, patients, the medical community
and healthcare payors, sufficient revenue may not be generated from these products and we may not become or remain profitable.
In addition, efforts to educate the medical community and third-party payors on the benefits of our product candidates may require
significant resources and may never be successful.
We
have no internal sales, distribution and/or marketing capabilities at this time and we will have to invest significant resources
to develop those capabilities or enter into acceptable third-party sales and marketing arrangements.
We
have no internal sales, distribution and/or marketing capabilities at this time. To develop these capabilities, we will have to
invest significant amounts of financial and management resources, some of which will be committed prior to any confirmation that
RP-G28 will be approved. For product candidates for which we decide to perform sales, marketing and distribution functions ourselves
or through third parties, we could face a number of additional risks, including:
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we
or our third-party sales collaborators may not be able to attract and build an effective marketing or sales force; |
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the
cost of securing or establishing a marketing or sales force may exceed the revenues generated by any products; and |
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our
direct sales and marketing efforts may not be successful. |
We
may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues
may depend heavily on the success of the efforts of these third parties.
We
may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely
affect our ability to develop RP-G28 or other product candidates and our financial condition and operating results.
Because
developing pharmaceutical products, conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities
and marketing approved products are expensive, we may seek to enter into collaborations with companies that have more experience.
Additionally, if RP-G28, or any other product candidate we develop in the future, receives marketing approval, we may enter into
sales and marketing arrangements with third parties with respect to our unlicensed territories. If we are unable to enter into
arrangements on acceptable terms, we may be unable to effectively market and sell our products in our target markets. We expect
to face competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming
to negotiate, document and implement and they may require substantial resources to maintain. We may not be successful in our efforts
to establish and implement collaborations or other alternative arrangements for the development of our product candidates.
When
we collaborate with a third party for the development and commercialization of a product candidate, we can expect to relinquish
some or all of the control over the future success of that product candidate to the third party. For example, we may relinquish
the rights to RP-G28 in jurisdictions outside of the United States. Our collaboration partner may not devote sufficient resources
to the commercialization of our product candidates or may otherwise fail in their commercialization. The terms of any collaboration
or other arrangement that we establish may not be favorable to us. In addition, any collaboration that we enter into may be unsuccessful
in the development and commercialization of our product candidates. In some cases, we may be responsible for continuing preclinical
and initial clinical development of a product candidate or research program under a collaboration arrangement, and the payment
we receive from our collaboration partner may be insufficient to cover the cost of this development. If we are unable to reach
agreements with suitable collaborators for our product candidates, we would face increased costs, we may be forced to limit the
number of our product candidates we can commercially develop or the territories in which we commercialize them and we might fail
to commercialize products or programs for which a suitable collaborator cannot be found. If we fail to achieve successful collaborations,
our operating results and financial condition will be materially and adversely affected.
The
Company’s pipeline of product candidates beyond RP-G28 is limited.
We
intend to develop and commercialize drug candidates in addition to RP-G28 through our research program. Even if we are successful
in completing preclinical and clinical development and receiving regulatory approval for one commercially viable drug for the
treatment of one disease, we cannot be certain that we will be able to develop and receive regulatory approval for other drug
candidates for the treatment of other forms of that disease or other diseases. If we fail to develop and commercialize RP-G28
for the reduction of symptoms associated with lactose intolerance, we will not be successful in developing a pipeline of potential
drug candidates to follow RP-G28, and our business prospects could be significantly limited.
Risks
Relating to Our Business and Strategy
We
may face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to
compete effectively.
Although
we know of no other drug candidates in advanced clinical trials for treating lactose intolerance, the biotechnology and pharmaceutical
industries are intensely competitive and subject to rapid and significant technological change. We have potential competitors
in the United States, Europe and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology
companies, specialty pharmaceutical and generic drug companies and universities and other research institutions. Many of these
potential competitors have greater financial and other resources, such as larger research and development staff and more experienced
marketing and manufacturing organizations. Large pharmaceutical companies, in particular, have extensive experience in clinical
testing, obtaining regulatory approvals, recruiting patients and manufacturing pharmaceutical products. These companies also have
significantly greater research, sales and marketing capabilities and collaborative arrangements in our target markets with leading
companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and
development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete.
As a result of all of these factors, these potential competitors may succeed in obtaining patent protection and/or FDA approval
or discovering, developing and commercializing drugs for the diseases that we are targeting before we do. Smaller or early-stage
companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established
companies. Some of the pharmaceutical and biotechnology companies we expect to compete with include microbiome based development
companies: Second Genome, Inc., Seres Health, Inc., Enterome SA, Vedanta Biosciences, Inc., and Microbiome Therapeutics, LLC.
In addition, many universities and private and public research institutes may become active in our target disease areas. These
potential competitors may succeed in developing, acquiring or licensing on an exclusive basis, technologies and drug products
that are more effective or less costly than RP-G28 or any other product candidates that we are currently developing or that we
may develop, which could render our products obsolete and noncompetitive.
We
believe that our ability to successfully compete will depend on, among other things:
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the
results of our and our potential strategic collaborators’ clinical trials and preclinical studies; |
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our
ability to recruit and enroll patients for our clinical trials; |
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the
efficacy, safety and reliability of our product candidates; |
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the
speed at which we develop our product candidates; |
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our
ability to design and successfully execute appropriate clinical trials; |
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our
ability to maintain a good relationship with regulatory authorities; |
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the
ability to get FDA approval of our end points; |
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the
timing and scope of regulatory approvals, if any; |
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our
ability to commercialize and market any of our product candidates that receive regulatory approval; |
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the
price of our products; |
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adequate
levels of reimbursement under private and governmental health insurance plans, including Medicare; |
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our
ability to protect intellectual property rights related to our products; |
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our
ability to manufacture and sell commercial quantities of any approved products to the market; and |
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acceptance
of our product candidates by physicians and other health care providers. |
If
our competitors market products that are more effective, safer or less expensive than ours, or that reach the market sooner than
ours, we may not achieve commercial success. In addition, the biopharmaceutical industry is characterized by rapid technological
change. Because our research approach integrates many technologies, it may be difficult for us to stay abreast of the rapid changes
in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological
advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive
or not economical.
We
depend on third-party contractors for a substantial portion of our operations and may not be able to control their work as effectively
as if we performed these functions ourselves.
We
outsource substantial portions of our operations to third-party service providers, including the conduct of preclinical studies
and clinical trials, collection and analysis of data, and manufacturing. Our agreements with third-party service providers and
CROs are on a study-by-study and project-by-project basis. Typically, we may terminate the agreements with notice and are responsible
for the supplier’s previously incurred costs. In addition, any CRO that we retain will be subject to the FDA’s and
EMA’s regulatory requirements and similar standards outside of the United States and Europe and we do not have control over
compliance with these regulations by these providers. Consequently, if these providers do not adhere to applicable governing practices
and standards, the development and commercialization of our product candidates could be delayed or stopped, which could severely
harm our business and financial condition.
Because
we have relied on third parties, our internal capacity to perform these functions is limited to management oversight. Outsourcing
these functions involves the risk that third parties may not perform to our standards, may not produce results in a timely manner
or may fail to perform at all. Although we have not experienced any significant difficulties with our third-party contractors,
it is possible that we could experience difficulties in the future. In addition, the use of third-party service providers requires
us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated.
There are a limited number of third-party service providers that specialize or have the expertise required to achieve our business
objectives. Identifying, qualifying and managing performance of third-party service providers can be difficult, time consuming
and cause delays in our development programs. We currently have a small number of employees, which limits the internal resources
we have available to identify and monitor third-party service providers. To the extent we are unable to identify, retain and successfully
manage the performance of third-party service providers in the future, our business may be adversely affected, and we may be subject
to the imposition of civil or criminal penalties if their conduct of clinical trials violates applicable law.
A
variety of risks associated with our possible international business relationships could materially adversely affect our business.
We
may enter into agreements with other third parties for the development and commercialization of RP-G28, or other product candidates
we develop in the future, in international markets. International business relationships subject us to additional risks that may
materially adversely affect our ability to attain or sustain profitable operations, including:
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differing
regulatory requirements for drug approvals internationally; |
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potentially
reduced protection for intellectual property rights; |
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potential
third-party patent rights in the United States and/or in countries outside of the United States; |
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the
potential for so-called “parallel importing,” which is what occurs when a local seller, faced with relatively
high local prices, opts to import goods from another jurisdiction with relatively low prices, rather than buying them locally;
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unexpected
changes in tariffs, trade barriers and regulatory requirements; |
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economic
weakness, including inflation, or political instability, particularly in non-U.S. economies and markets, including several
countries in Europe; |
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compliance
with tax, employment, immigration and labor laws for employees traveling abroad; |
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taxes
in other countries; |
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foreign
currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident
to doing business in another country; |
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workforce
uncertainty in countries where labor unrest is more common than in the United States; |
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production
shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
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business
interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes,
volcanoes, typhoons, floods, hurricanes and fires. |
We
will need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.
As
we increase the number of ongoing product development programs and advance our product candidates through preclinical studies
and clinical trials, we will need to increase our product development, scientific and administrative headcount to manage these
programs. In addition, to meet our obligations as a public company, we will need to increase our general and administrative capabilities.
Our management, personnel and systems currently in place may not be adequate to support this future growth. Our need to effectively
manage our operations, growth and various projects requires that we:
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successfully
attract and recruit new employees or consultants with the expertise and experience we will require; |
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manage
our clinical programs effectively, which we anticipate being conducted at numerous clinical sites; |
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develop
a marketing and sales infrastructure; and |
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continue
to improve our operational, financial and management controls, reporting systems and procedures. |
If
we are unable to successfully manage this growth and increased complexity of operations, our business may be adversely affected.
We
may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants.
We
may not be able to attract or retain qualified management, finance, scientific and clinical personnel and consultants due to the
intense competition for qualified personnel and consultants among biotechnology, pharmaceutical and other businesses. If we are
not able to attract and retain necessary personnel and consultants to accomplish our business objectives, we may experience constraints
that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our
ability to implement our business strategy.
We
are highly dependent on the development, regulatory, commercialization and business development expertise of Michael D. Step,
our Chief Executive Officer, Andrew J. Ritter, our Founder and President, and Ira E. Ritter, our Executive Chairman and Chief
Strategic Officer. If we were to lose one or more of these key employees, our ability to implement our business strategy successfully
could be seriously harmed. Any of our executive officers may terminate their employment at any time. Replacing any of these persons
would be difficult and could take an extended period of time because of the limited number of individuals in our industry with
the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully.
There
is also a risk that other obligations could distract our officers and employees, including any of our other part-time employees,
from our business, which could have negative impact on our ability to effectuate our business plans.
In
addition, we have scientific and clinical advisors and consultants who assist us in formulating our research, development and
clinical strategies. Competition to hire and retain consultants from a limited pool is intense. Further, because these advisors
are not our employees, they may have commitments to, or consulting or advisory contracts with, other entities that may limit their
availability to us, and typically they will not enter into non-compete agreements with us. If a conflict of interest arises between
their work for us and their work for another entity, we may lose their services. In addition, our advisors may have arrangements
with other companies to assist those companies in developing products or technologies that may compete with ours.
Failure
to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the
financial reporting and internal controls requirements for publicly traded companies.
As
a public company, we will operate in an increasingly demanding regulatory environment, which requires us to comply with the Sarbanes-Oxley
Act, and the related rules and regulations of the SEC, expanded disclosure requirements, accelerated reporting requirements and
more complex accounting rules. Company responsibilities required by the Sarbanes-Oxley Act include establishing corporate oversight
and adequate internal control over financial reporting and disclosure controls and procedures. Effective internal controls are
necessary for us to produce reliable financial reports and are important to help prevent financial fraud.
We
have begun implementing our system of internal controls over financial reporting and preparing the documentation necessary to
perform the evaluation needed to comply with Section 404(a) of the Sarbanes-Oxley Act. However, we anticipate that we will need
to retain additional finance capabilities and build our financial infrastructure as we transition to operating as a public company,
including complying with the requirements of Section 404 of the Sarbanes-Oxley Act. As we continue to operate as a public company,
we will continue improving our financial infrastructure with the retention of additional financial and accounting capabilities,
the enhancement of internal controls and additional training for our financial and accounting staff.
Section
404(a) of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial
reporting, starting with the second annual report that we would expect to file with the SEC. However, for as long as we remain
an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions from various
reporting requirements that are applicable to other public companies that are not “emerging growth companies” including,
but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley
Act. We may take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We will
remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary
of the date we completed our initial public offering, which was June 29, 2015, (b) in which we have total annual gross revenue
of at least $1.0 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common
stock that is held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (ii) the date on which
we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
Until
we are able to expand our finance and administrative capabilities and establish necessary financial reporting infrastructure,
we may not be able to prepare and disclose, in a timely manner, our financial statements and other required disclosures or comply
with the Sarbanes-Oxley Act or existing or new reporting requirements. If we cannot provide reliable financial reports or prevent
fraud, our business and results of operations could be harmed and investors could lose confidence in our reported financial information.
Our
employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
and insider trading, which could significantly harm our business.
We
are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply
with the regulations of the FDA and non-U.S. regulators, provide accurate information to the FDA and non-U.S. regulators, comply
with health care fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately
or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the health care industry
are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive
practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion,
sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper
use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our
reputation. We have adopted an employee handbook, but it is not always possible to identify and deter employee misconduct, and
the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or
losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with
these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or
asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines
or other sanctions.
We
face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability
for a product candidate and may have to limit its commercialization.
The
use of our product candidates in clinical trials and the sale of any products for which we may obtain marketing approval expose
us to the risk of product liability claims. Product liability claims may be brought against us or our potential future collaborators
by participants enrolled in our clinical trials, patients, health care providers or others using, administering or selling our
products. If we cannot successfully defend ourselves against any such claims, we would incur substantial liabilities. Regardless
of merit or eventual outcome, product liability claims may result in:
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withdrawal
of clinical trial participants; |
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termination
of clinical trial sites or entire trial programs; |
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costs
of related litigation; |
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substantial
monetary awards to patients or other claimants; |
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decreased
demand for our product candidates and loss of revenues; |
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impairment
of our business reputation; |
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diversion
of management and scientific resources from our business operations; and |
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the
inability to commercialize our product candidates. |
We
expect to obtain product liability insurance coverage for our clinical trials in the United States and in selected other jurisdictions
where we intend to conduct clinical trials at levels we believe are sufficient and consistent with industry standards for companies
at our stage of development. However, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for
any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we
may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due
to product liability. We intend to expand our insurance coverage for products to include the sale of commercial products if we
obtain marketing approval for our product candidates in development, but we may be unable to obtain commercially reasonable product
liability insurance for any products approved for marketing. Large judgments have been awarded in class action lawsuits based
on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly
if judgments exceed our insurance coverage, could decrease our cash resources and adversely affect our business.
Our
insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured
liabilities.
We
do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain
include general liability ($2.0 million coverage), employment practices liability, workers’ compensation, and directors’
and officers’ insurance at levels we believe are typical for a company in our industry and at our stage of development.
We do not currently carry clinical trial liability insurance or products liability insurance, but we are currently seeking to
purchase such insurance prior to the beginning of our clinical trials at levels we believe are sufficient and consistent with
industry standards for companies at our stage of development. We do not know, however, if we will be able to maintain insurance
with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely
affect our financial position and results of operations.
If
we engage in an acquisition, reorganization or business combination, we will incur a variety of risks that could adversely affect
our business operations or our stockholders.
From
time to time we have considered, and we will continue to consider in the future, strategic business initiatives intended to further
the expansion and development of our business. These initiatives may include acquiring businesses, technologies or products or
entering into a business combination with another company. If we pursue such a strategy, we could, among other things:
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issue
equity securities that would dilute our current stockholders’ percentage ownership; |
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incur
substantial debt that may place strains on our operations; |
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spend
substantial operational, financial and management resources to integrate new businesses, technologies and products; |
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assume
substantial actual or contingent liabilities; |
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reprioritize
our development programs and even cease development and commercialization of our product candidates; or |
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merge
with, or otherwise enter into a business combination with, another company in which our stockholders would receive cash and/or
shares of the other company on terms that certain of our stockholders may not deem desirable. |
Although
we intend to evaluate and consider acquisitions, reorganizations and business combinations in the future, we have no agreements
or understandings with respect to any acquisition, reorganization or business combination at this time.
Risks
Relating to Our Intellectual Property
It
is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position
does not adequately protect our product candidates, others could compete against us more directly, which would harm our business,
possibly materially.
Our
commercial success will depend in part on obtaining, maintaining and enforcing patent protection and on developing, preserving
and enforcing current trade secret protection. In particular, it will depend in part on our ability to obtain, maintain and enforce
patents, especially those related to methods of using our current product, RP-G28, and other future drug candidates, and those
related to the methods used to develop and manufacture our products, as well as successfully defending these patents against third-party
challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our products depends
on the extent to which we have rights under valid and enforceable patents (and/or trade secrets) that cover these activities.
We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent
applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted
to us in the future will withstand subsequent challenges to their validity and or patentability, or if they will be commercially
useful in protecting our product candidates, discovery programs and processes. Furthermore, we cannot be sure that our existing
patents and patent applications will embrace (or “claim”) the particular uses for RP-G28 that will be approved by
FDA.
The
patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions
for which important legal principles remain unresolved.
No
consistent policy regarding the patentability and/or validity of patent claims related to pharmaceutical patents has emerged,
to date, in the United States or in most jurisdictions outside of the United States. Changes in either the patent laws (be they
substantive or procedural) or in the interpretations of patent laws in the United States and other countries may diminish the
value of our intellectual property. Accordingly, we cannot predict the breadth of claims that will issue or will be enforceable
in the patents that have or may be issued from the patents and applications we currently own or may in the future own or license
from third parties. Further, if any patents we obtain, or to which we obtain licenses, are deemed invalid, unpatentable and unenforceable,
our ability to commercialize or license our technology could be adversely affected.
In
the future others may file patent applications covering products, uses for products, and manufacturing techniques and related
technologies that are similar, identical or competitive to ours or important to our business. We cannot be certain that any patent
application owned by a third party will not have priority over patent applications filed or in-licensed by us in the future, or
that we or our licensors will not be involved in interference, opposition, inter partes review or invalidity proceedings before
U.S. or non-U.S. patent offices or courts.
The
degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may
not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:
| ● | others
may be able to develop a platform similar to, or better than, ours in a way that is not
covered by the claims of our patents; |
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may be able to make compounds that are similar to our product candidates but that are
not covered by the claims of our patents; |
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may be able to manufacture compounds that are similar or identical to our product candidates
using processes that are not covered by the claims of our method of making patents; |
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may obtain regulatory approval for uses of compounds, similar or identical to our product,
that are not covered by the claims of our method of use patents; |
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may not be able to obtain licenses for patents that are essential to the process of making
the product; |
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might not have been the first to make the inventions covered by our pending patent applications; |
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might not have been the first to file patent applications for these inventions; |
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may independently develop similar or alternative technologies or duplicate any of our
technologies; |
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patents that we obtain may not provide us with any competitive advantages; |
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may not develop additional proprietary technologies that are patentable; or |
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patents of others may have an adverse effect on our business. |
Patents
covering methods of using RP-G28 expire in 2030 if the appropriate maintenance fee renewal, annuity, or other government fees
are paid, unless a patent term extension based on regulatory delay is obtained. We expect that expiration in 2030 of some of our
method-of-use patents covering use of RP-G28 for treating lactose intolerance will have a limited impact on our ability to protect
our intellectual property in the United States, where we have additional issued patents covering this use that extend until 2030.
In other countries, our pending patent applications covering use of RP-G28 for treating other indications, if issued, would expire
in 2030. We will attempt to mitigate the effect of patent expiration by seeking data exclusivity, or the foreign equivalent thereof,
in conjunction with product approval, as well as by filing additional patent applications covering improvements in our intellectual
property.
We
expect that the other patent applications for the RP-G28 portfolio, if issued, and if the appropriate maintenance, renewal, annuity
or other governmental fees are paid, would expire in 2030. We own pending applications in the United States and Europe covering
RP-G28 analogs, and uses of such analogs as therapeutics to treat a variety of disorders, including lactose intolerance. Patent
protection, to the extent it issues, would be expected to extend to 2030, unless a patent term extension based on regulatory delay
is obtained.
Due
to the patent laws of a country, or the decisions of a patent examiner in a country, or our own filing strategies, we may not
obtain patent coverage for all of our product candidates or methods involving these candidates in the parent patent application.
We plan to pursue divisional patent applications or continuation patent applications in the United States and other countries
to obtain claim coverage for inventions which were disclosed but not claimed in the parent patent application.
We
may also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate
or feasible. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets,
our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully
disclose our information to competitors. Enforcing a claim that a third party illegally obtained and is using any of our trade
secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes
less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
RP-G28
does not have composition of matter patent protection.
Although
we own certain patents and patent applications with claims directed to specific methods of using RP-G28 to treat lactose intolerance,
RP-G28 has no composition of matter patent protection in the United States or elsewhere. As a result, we may be limited in our
ability to list our patents in the FDA’s Orange Book if the use of our product, consistent with its FDA-approved label,
would not fall within the scope of our patent claims. Also, our competitors may be able to offer and sell products so long as
these competitors do not infringe any other patents that we (or third parties) hold, including patents with claims directed to
the manufacture of RP-G28 and/or method of use patents. In general, method of use patents are more difficult to enforce than composition
of matter patents because, for example, of the risks that FDA may approve alternative uses of the subject compounds not covered
by the method of use patents, and others may engage in off-label sale or use of the subject compounds. Physicians are permitted
to prescribe an approved product for uses that are not described in the product’s labeling. Although off-label prescriptions
may infringe our method of use patents, the practice is common across medical specialties and such infringement is difficult to
prevent or prosecute. FDA approval of uses that are not covered by our patents would limit our ability to generate revenue from
the sale of RP-G28, if approved for commercial sale. Off-label sales would limit our ability to generate revenue from the sale
of RP-G28, if approved for commercial sale.
We
may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property
rights.
If
we choose to go to court to stop another party from using the inventions claimed in any patents we obtain, that individual or
company may seek a post grant review (including inter parte review) of our patents, and has the right to ask the court to rule
that such patents are invalid or should not be enforced against that third party. These lawsuits and administrative proceedings
are expensive and would consume time and resources and divert the attention of managerial and scientific personnel even if we
were successful in stopping the infringement of such patents. In addition, there is a risk that the court or administrative body
will decide that such patents are not valid or unpatentable and that we do not have the right to stop the other party from using
the inventions. There is also the risk that, even if the validity/patentability of such patents is upheld, the court will refuse
to stop the other party on the ground that such other party’s activities do not infringe our rights to such patents. In
addition, the U.S. Supreme Court and the Court of Appeals for the Federal Circuit have recently articulated and/or modified certain
tests used by the U.S. Patent and Trademark Office, or USPTO, in assessing patentability and by the courts in assessing validity
and claim scope, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood that others
may succeed in challenging any patents we obtain or license.
We
may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us
from commercializing or increase the costs of commercializing our product candidates.
Our
success will depend in part on our ability to operate without infringing the proprietary rights of third parties. We cannot guarantee
that our products, our methods of manufacture, or our uses of RP-G28 (or our other product candidates), will not infringe third-party
patents. Furthermore, a third party may claim that we or our manufacturing or commercialization collaborators are using inventions
covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities,
including making or selling our product candidates. These lawsuits are costly and could affect our results of operations and divert
the attention of managerial and scientific personnel. There is a risk that a court would decide that we or our commercialization
collaborators are infringing the third party’s patents and would order us or our collaborators to stop the activities covered
by the patents. In that event, we or our commercialization collaborators may not have a viable way around the patent and may need
to halt commercialization of the relevant product. In addition, there is a risk that a court will order us or our collaborators
to pay the other party damages for having violated the other party’s patents. In the future, we may agree to indemnify our
commercial collaborators against certain intellectual property infringement claims brought by third parties. The pharmaceutical
and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants, including
us, which patents cover various types of products or methods of use. The scope of coverage of a patent is subject to interpretation
by the courts, and the interpretation is not always uniform. If we are sued for patent infringement, the patentee would need to
demonstrate, by a preponderance of the evidence that our products or methods infringe the patent claims of the relevant patent,
and we would need to demonstrate either that we do not infringe or, by clear and convincing evidence, that the patent claims are
invalid; we may not be able to do this. Proving invalidity is difficult. For example, in the United States, proving invalidity
requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if
we are successful in these proceedings, we may incur substantial costs and divert management’s time and attention in pursuing
these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of
others, we may be required to seek a license, which may not be available, defend an infringement action or challenge the validity
of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions
to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend
an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter
significant delays in bringing our product candidates to market and be precluded from manufacturing or selling our product candidates.
We
cannot be certain that others have not filed patent applications for technology covered by our pending applications, or that we
were the first to invent the technology, because:
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some
patent applications in the United States may be maintained in secrecy until the patents are issued; |
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patent
applications in the United States are typically not published until at least 18 months after the earliest asserted priority
date; and |
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publications
in the scientific literature often lag behind actual discoveries. |
Our
competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent
application may have priority over our patent applications, which could further require us to obtain rights to issued patents
covering such technologies. If another party has filed a U.S. patent application on inventions similar to ours, we may have to
participate in an interference proceeding declared by the USPTO to determine priority of invention in the United States. The costs
of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful if, unbeknownst to us, the
other party had independently arrived at the same or similar invention prior to our own invention, resulting in a loss of our
U.S. patent position with respect to such inventions. Other countries have similar laws that permit secrecy of patent applications,
and may be entitled to priority over our applications in such jurisdictions.
Some
of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have
substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation
could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
Obtaining
and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other
requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance
with these requirements.
Periodic
maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to
be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime
of the patents and/or applications. We employ an outside firm and rely on our outside counsel to pay these fees due to non-U.S.
patent agencies and this outside firm has systems in place to ensure compliance on payment of fees. The USPTO and various non-U.S.
governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases,
an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However,
there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting
in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to
enter the market and this circumstance would have a material adverse effect on our business.
We
may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology
and products could be significantly diminished.
As
is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology
or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees,
or we, have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.
Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation
could result in substantial costs and be a distraction to management.
We
rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate
or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees,
consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other
proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide
an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently
discover our trade secrets and proprietary information. For example, the FDA, as part of its Transparency Initiative, is currently
considering whether to make additional information publicly available on a routine basis, including information that we may consider
to be trade secrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies
may change in the future, if at all. Costly and time-consuming litigation could be necessary to enforce and determine the scope
of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business
position.
Failure
to secure trademark registrations could adversely affect our business.
We
have not developed a trademark for our RP-G28 product. Hence, we do not currently own any actual or potential trademark rights
associated with our RP-G28 product. If we seek to register additional trademarks, including trademarks associated with our RP-G28
product, our trademark applications may not be allowed for registration or our registered trademarks may not be maintained or
enforced. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond
to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many
other jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered
trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such
proceedings. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against
third parties than we otherwise would.
Risks
Relating to Our Common Stock and this Offering
An
active trading market may not develop or be sustained.
Prior
to our initial public offering, there was no public market for our common stock. Since our initial public offering in June 2015,
there has been, and we expect that there will continue to be, only a limited volume of trading in our common stock. An active
trading market in our common stock may not develop or, if developed, may not be sustained. The lack of an active market may impair
your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an
active market may also reduce the fair market value of your shares. An inactive market may also impair our ability to raise capital
to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using
our shares as consideration.
Our
share price may be volatile, which could subject us to securities class action litigation and prevent you from being able to sell
your shares at or above your purchase price.
The
market price of shares of our common stock could be subject to wide fluctuations in response to many risk factors listed in this
section, and others beyond our control, including:
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results
of our clinical trials; |
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results
of clinical trials of our competitors’ products; |
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regulatory
actions with respect to our products or our competitors’ products; |
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actual
or anticipated fluctuations in our financial condition and operating results; |
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actual
or anticipated changes in our growth rate relative to our competitors; |
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actual
or anticipated fluctuations in our competitors’ operating results or changes in their growth rate; |
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competition
from existing products or new products that may emerge; |
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announcements
by us, our potential future collaborators or our competitors of significant acquisitions, strategic collaborations, joint
ventures, or capital commitments; |
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issuance
of new or updated research or reports by securities analysts; |
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fluctuations
in the valuation of companies perceived by investors to be comparable to us; |
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share
price and volume fluctuations attributable to inconsistent trading volume levels of our shares; |
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additions
or departures of key management or scientific personnel; |
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disputes
or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent
protection for our technologies; |
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announcement
or expectation of additional financing efforts; |
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sales
of our common stock by us, our insiders or our other stockholders; |
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market
conditions for biopharmaceutical stocks in general; and |
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general
economic and market conditions. |
Furthermore,
the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market
prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating
performance of those companies. These broad market and industry fluctuations, as well as general economic, political and market
conditions such as recessions, interest rate changes or international currency fluctuations, may negatively impact the market
price of shares of our common stock. In addition, such fluctuations could subject us to securities class action litigation, which
could result in substantial costs and divert our management’s attention from other business concerns, which could seriously
harm our business.
We
have three significant stockholders, which will limit your ability to influence corporate matters and may give rise to conflicts
of interest.
Javelin
Venture Partners I SPV I, LLC, or Javelin SPV, Javelin Venture Partners, L.P., or Javelin, and Stonehenge Partners LLC, or Stonehenge,
are our largest stockholders. Javelin SPV beneficially owns shares representing approximately 3.8% of our common stock outstanding,
Javelin beneficially owns shares representing approximately 23.9% of our outstanding common stock, and Stonehenge beneficially
owns shares representing 9.5% of our common stock. Further, Noah Doyle, one of our directors, is a managing director of Javelin
SPV and Javelin, and Andrew Ritter and Ira Ritter, members of management and directors on our board of directors, are managing
partners of Stonehenge. Accordingly, Javelin SPV, Javelin and Stonehenge may exert significant influence over us and any action
requiring the approval of the holders of our common stock, including the election of directors and the approval of significant
corporate transactions. This concentration of voting power makes it less likely that any other holder of our common stock will
be able to affect the way we are managed and could delay or prevent an acquisition of us on terms that other stockholders may
desire. Furthermore, the interests of Javelin SPV, Javelin and Stonehenge may not always coincide with your interests or the interests
of other stockholders and Javelin SPV, Javelin and Stonehenge may act in a manner that advances their best interests and not necessarily
those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market
price for our common stock.
Being
a public company has increased our expenses and administrative burden.
As
a public company, we have incurred and will continue to incur significant legal, insurance, accounting and other expenses that
we did not incur as a private company. In addition, our administrative staff is required to perform tasks they did not perform
when we were a private company. For example, as a public company, we must bear all of the internal and external costs of preparing
and distributing periodic public reports in compliance with our obligations under the securities laws. In addition, laws, regulations
and standards applicable to public companies relating to corporate governance and public disclosure, including the Sarbanes-Oxley
Act and related regulations implemented by the SEC and NASDAQ, create uncertainty for public companies, increasing legal and financial
compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying
interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over
time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance
matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We have invested and will continue
to invest resources to comply with evolving laws, regulations and standards, and this investment will result in increased general
and administrative expenses and may divert management’s time and attention from product development activities. If our efforts
to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to
ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.
In the future, it may become more expensive for us to maintain director and officer liability insurance, and we may be required
to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult
for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation
committee, and qualified executive officers.
We
are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable
to emerging growth companies, which could make our common stock less attractive to investors.
We
are an “emerging growth company,” as defined in the JOBS Act and we intend to take advantage of certain exemptions
from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”
including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act,
reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from
the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute
payments not previously approved. We cannot predict if investors will find our common stock less attractive because we may rely
on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market
for our common stock and our stock price may be more volatile.
We
may take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We will remain
an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary
of the date we completed our initial public offering, which was June 29, 2015, (b) in which we have total annual gross revenue
of at least $1.0 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common
stock that is held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (ii) the date on which
we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
The
sale of our common stock to Aspire Capital may cause substantial dilution to our existing stockholders and the sale of the shares
of common stock acquired by Aspire Capital could cause the price of our common stock to decline.
We
are registering for sale the Commitment Shares and Initial Purchase Shares that we have issued to Aspire Capital and an additional
888,835 shares that we may issue to Aspire Capital after this registration statement is declared effective under the Securities
Act. It is anticipated that shares registered in this offering will be sold over a period of up to approximately 30 months after
this registration statement is declared effective under the Securities Act. The number of shares ultimately offered for sale by
Aspire Capital under this prospectus is dependent upon the number of shares we elect to sell to Aspire Capital under the Purchase
Agreement. Depending on a variety of factors, including market liquidity of our common stock, the sale of shares under the Purchase
Agreement may cause the trading price of our common stock to decline.
Aspire
Capital may ultimately purchase all, some or none of the $9.0 million of common stock that, together with the $1.0 million Initial
Purchase Shares and the Commitment Shares, are the subject of this prospectus. Aspire Capital may sell all, some or none of our
shares that it holds or comes to hold under the Purchase Agreement. Sales by Aspire Capital of shares acquired pursuant to the
Purchase Agreement under the registration statement, of which this prospectus is a part, may result in dilution to the interests
of other holders of our common stock. The sale of a substantial number of shares of our common stock by Aspire Capital in this
offering, or anticipation of such sales, could cause the trading price of our common stock to decline or make it more difficult
for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise desire. However,
we have the right under the Purchase Agreement to control the timing and amount of sales of our shares to Aspire Capital, and
the Purchase Agreement may be terminated by us at any time at our discretion without any penalty or cost to us.
Future
sales of our common stock, or the perception that future sales may occur, may cause the market price of our common stock to decline,
even if our business is doing well.
Sales
of a substantial number of shares of our common stock in the public market could occur in the future. These sales, or the perception
in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price
of our common stock. We had 8,582,009 outstanding shares of common stock as of December 30, 2015, which includes the 500,000 Initial
Purchase Shares and 188,864 Commitment Shares that have been issued to Aspire Capital, but excludes the 888,835 shares which we
may issue to Aspire Capital after this registration statement is declared effective under the Securities Act. Of these shares,
a total of 5,865,861 shares may be resold in the public market at any time after this registration statement is declared effective
under the Securities Act (including the shares registered in this offering) and the remaining 2,716,148 shares are currently restricted
under securities laws. We have also registered 2,111,682 shares of common stock that we may issue under our equity compensation
plans. These shares can be sold in the public market upon issuance and once vested.
If
securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our
share price and trading volume could decline.
The
trading market for our common stock will depend on the research and reports that securities or industry analysts publish about
us or our business. We do not have any control over these analysts. There can be no assurance that analysts will cover us or provide
favorable coverage. If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our
share price would likely decline. If one or more of these analysts cease coverage of our company or fail to regularly publish
reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.
Our
failure to meet the continued listing requirements of NASDAQ could result in a de-listing of our common stock.
If
we fail to satisfy the continued listing requirements of NASDAQ, such as the corporate governance requirements or the minimum
closing bid price requirement, NASDAQ may take steps to de-list our common stock. Such a de-listing would likely have a negative
effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do
so. In the event of a de-listing, we would take actions to restore our compliance with NASDAQ’s listing requirements, but
we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the
market price or improve the liquidity of our common stock, prevent our common stock from dropping below the NASDAQ minimum bid
price requirement or prevent future non-compliance with NASDAQ’s listing requirements.
Provisions
in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to
our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions
in our amended and restated certificate of incorporation and our amended and restated bylaws may discourage, delay or prevent
a merger, acquisition or other change in control of our company that stockholders may consider favorable, including transactions
in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might
be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition,
because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate
or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders
to replace members of our board of directors. Among other things, these provisions provide that:
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the
authorized number of directors can be changed only by resolution of our board of directors; |
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our
bylaws may be amended or repealed by our board of directors or our stockholders; |
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stockholders
may not call special meetings of the stockholders or fill vacancies on the board of directors; |
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our
board of directors is authorized to issue, without stockholder approval, preferred stock, the rights of which will be determined
at the discretion of the board of directors and that, if issued, could operate as a “poison pill” to dilute the
stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors does not approve; |
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our
stockholders do not have cumulative voting rights, and therefore our stockholders holding a majority of the shares of common
stock outstanding will be able to elect all of our directors; and |
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our
stockholders must comply with advance notice provisions to bring business before or nominate directors for election at a stockholder
meeting. |
Moreover,
because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation
Law, or DGCL, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with
us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding
voting stock, unless the merger or combination is approved in a prescribed manner.
Claims
for indemnification by our directors and officers may reduce our available funds to satisfy successful stockholder claims against
us and may reduce the amount of money available to us.
As
permitted by Section 102(b)(7) of the DGCL, our amended and restated certificate of incorporation limits the liability of our
directors to the fullest extent permitted by law. In addition, as permitted by Section 145 of the DGCL, our amended and restated
certificate of incorporation and our amended and restated bylaws provide that we shall indemnify, to the fullest extent authorized
by the DGCL, each person who is involved in any litigation or other proceeding because such person is or was a director or officer
of our company or is or was serving as an officer or director of another entity at our request, against all expense, loss or liability
reasonably incurred or suffered in connection therewith. Our amended and restated certificate of incorporation provides that the
right to indemnification includes the right to be paid expenses incurred in defending any proceeding in advance of its final disposition,
provided, however, that such advance payment will only be made upon delivery to us of an undertaking, by or on behalf of the director
or officer, to repay all amounts so advanced if it is ultimately determined that such director is not entitled to indemnification.
If we do not pay a proper claim for indemnification in full within 60 days after we receive a written claim for such indemnification,
except in the case of a claim for an advancement of expenses, in which case such period is 20 days, our restated certificate of
incorporation and our restated bylaws authorize the claimant to bring an action against us and prescribe what constitutes a defense
to such action.
Section
145 of the DGCL permits a corporation to indemnify any director or officer of the corporation against expenses (including attorney’s
fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with any action, suit or
proceeding brought by reason of the fact that such person is or was a director or officer of the corporation, if such person acted
in good faith and in a manner that he reasonably believed to be in, or not opposed to, the best interests of the corporation,
and, with respect to any criminal action or proceeding, if he or she had no reason to believe his or her conduct was unlawful.
In a derivative action, (i.e., one brought by or on behalf of the corporation), indemnification may be provided only for
expenses actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action
or suit if such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the
best interests of the corporation, except that no indemnification shall be provided if such person shall have been adjudged to
be liable to the corporation, unless and only to the extent that the court in which the action or suit was brought shall determine
that the defendant is fairly and reasonably entitled to indemnity for such expenses despite such adjudication of liability.
The
rights conferred in the restated certificate of incorporation and the restated bylaws are not exclusive, and we are authorized
to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify
such persons. We have entered into indemnification agreements with each of our officers and directors.
The
above limitations on liability and our indemnification obligations limit the personal liability of our directors and officers
for monetary damages for breach of their fiduciary duty as directors by shifting the burden of such losses and expenses to us.
Although we plan to increase the coverage under our directors’ and officers’ liability insurance, certain liabilities
or expenses covered by our indemnification obligations may not be covered by such insurance or the coverage limitation amounts
may be exceeded. As a result, we may need to use a significant amount of our funds to satisfy our indemnification obligations,
which could severely harm our business and financial condition and limit the funds available to stockholders who may choose to
bring a claim against our company.
We
have never paid dividends on our common stock and do not anticipate paying dividends for the foreseeable future, and accordingly,
stockholders must rely on stock appreciation for any return on their investment.
We
have never paid dividends on our common stock and we do not anticipate paying dividends on our common stock for the foreseeable
future. Accordingly, any return on an investment in our common stock will be realized, if at all, only when stockholders sell
their shares. In addition, our failure to pay dividends may make our stock less attractive to investors, adversely impacting trading
volume and price.
Our
ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
As
of December 31, 2014, we had federal net operating loss carryforwards, or NOLs, of approximately $9.7 million which begin to expire
in 2028. Our ability to utilize our NOLs may be limited under Section 382 and 383 of the Internal Revenue Code. The limitations
apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders
increase their aggregate ownership by more than 50 percentage points over their lowest ownership percentage in a testing period
(typically three years). Although we have not undergone a Section 382 analysis, it is possible that the utilization of the NOLs,
could be substantially limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be utilized against
future taxes. As a result, we may not be able to take full advantage of these carryforwards for federal and state tax purposes.
Future changes in stock ownership may also trigger an ownership change and, consequently, a Section 382 limitation.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.. All statements other than statements of historical facts contained
in this prospectus, including statements regarding our strategy, future operations, future financial position, future revenue,
projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements
involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
The
words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include,
among other things, statements about:
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our
ability to sell shares of common stock to Aspire Capital pursuant to the Purchase Agreement and our ability to register and
maintain the registration of the shares issued and issuable thereunder; |
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our
ability to obtain additional financing; |
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the
accuracy of our estimates regarding expenses, future revenues and capital requirements; |
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the
success and timing of our preclinical studies and clinical trials; |
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our
ability to obtain and maintain regulatory approval of RP-G28 and any other product candidates we may develop, and the labeling
under any approval we may obtain; |
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regulatory
developments in the United States and other countries; |
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the
performance of third-party manufacturers; |
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our
plans to develop and commercialize our product candidates; |
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our
ability to obtain and maintain intellectual property protection for our product candidates; |
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the
successful development of our sales and marketing capabilities; |
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the
potential markets for our product candidates and our ability to serve those markets; |
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the
rate and degree of market acceptance of any future products; |
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the
success of competing drugs that are or become available; and |
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the
loss of key scientific or management personnel. |
These
forward-looking statements are only predictions and we may not actually achieve the plans, intentions or expectations disclosed
in our forward-looking statements, so you should not place undue reliance on our forward-looking statements. Actual results or
events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends
that we believe may affect our business, financial condition and operating results. We have included important factors in the
cautionary statements included in this prospectus, particularly in the “Risk Factors” section, that could cause actual
future results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements
do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
The
forward-looking statements in this prospectus represent our views as of the date of this prospectus. We anticipate that subsequent
events and developments will cause our views to change. However, while we may elect to update these forward-looking statements
at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should,
therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this
prospectus.
This
prospectus contains estimates made, and other statistical data published, by independent parties and by us relating to market
size and growth and other data about our industry. We obtained the industry and market data in this prospectus from our own research
as well as from industry and general publications, surveys and studies conducted by third parties. This data involves a number
of assumptions and limitations and contains projections and estimates of the future performance of the industries in which we
operate that are subject to a high degree of uncertainty. We caution you not to give undue weight to such projections, assumptions
and estimates.
THE
ASPIRE CAPITAL TRANSACTION
General
On
December 18, 2015, we entered into the Purchase Agreement which provides that, upon the terms and subject to the conditions and
limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of our shares of common
stock over the term of the Purchase Agreement. Upon execution of the Purchase Agreement, the Company agreed to sell to Aspire
Capital 500,000 Initial Purchase Shares for proceeds of $1.0 million. In consideration for entering into the Purchase Agreement,
concurrently with the execution of the Purchase Agreement, we issued to Aspire Capital 188,864 Commitment Shares. Concurrently
with entering into the Purchase Agreement, we also entered into the Registration Rights Agreement, in which we agreed to file
one or more registration statements as permissible and necessary to register under the Securities Act, the sale of the shares
of our common stock that have been and may be issued to Aspire Capital under the Purchase Agreement.
As
of December 30, 2015 there were 8,582,009 shares of our common stock outstanding (of which 5,317,454 shares were held by non-affiliates
including Aspire Capital), which includes the 500,000 Initial Purchase Shares and 188,864 Commitment Shares that have already
been issued to Aspire Capital, but excludes the 888,835 shares which we may issue to Aspire Capital after this registration statement
is declared effective under the Securities Act. If all 1,577,699 shares of our common stock issuable to Aspire Capital had been
issued and outstanding as of December 30, 2015, such shares would have represented 16.7% of the total common stock outstanding,
or 25.4% of the non-affiliate shares of common stock outstanding, as of December 30, 2015. The number of shares of our common
stock ultimately offered for sale by Aspire Capital is dependent upon the number of shares purchased by Aspire Capital under the
Purchase Agreement.
The
aggregate number of shares that we may issue to Aspire Capital under the Purchase Agreement may in no case exceed 1,577,699 shares
of our common stock (which is equal to approximately 19.99% of the common stock outstanding on the date of the Purchase Agreement),
unless (i) shareholder approval is obtained to issue more, in which case this 1,577,699 share limitation, will not apply, or (ii)
shareholder approval has not been obtained and at any time the 1,577,699 share limitation is reached and at all times thereafter
the average price paid for all shares issued under the Purchase Agreement (including the Commitment Shares) is equal to or greater
than $1.75, the Minimum Price, a price equal to the closing sale price of our common stock on the business date of the execution
of the Purchase Agreement; provided that at no one point in time shall Aspire Capital (together with its affiliates) beneficially
own more than 19.99% of our common stock.
Pursuant
to the Purchase Agreement and the Registration Rights Agreement, we are registering 1,577,699 shares of our common stock under
the Securities Act, which includes the Initial Purchase Shares and the Commitment Shares that have already been issued to Aspire
Capital and 888,835 shares of common stock that we may issue to Aspire Capital after this registration statement is declared effective
under the Securities Act. All 1,577,699 shares of common stock are being offered pursuant to this prospectus. Under the Purchase
Agreement, we have the right but not the obligation to issue more than the 1,577,699 shares of common stock included in this prospectus
to Aspire Capital. As of the date hereof, we do not have any plans or intent to issue to Aspire Capital any shares of common stock
in addition to the 1,577,699 shares of common stock offered hereby.
After
the SEC has declared effective the registration statement of which this prospectus is a part, on any trading day on which the
closing sale price of our common stock is not less than $0.50 per share, or the Floor Price, we have the right, in our sole discretion,
to present Aspire Capital with a Purchase Notice, directing Aspire Capital (as principal) to purchase up to 100,000 shares of
our common stock per business day, up to $9.0 million of our common stock in the aggregate over the term of the Purchase Agreement,
at a Purchase Price calculated by reference to the prevailing market price of our common stock over the preceding 12-business
day period (as more specifically described below); however, no sale pursuant to a Purchase Notice may exceed $500,000 per trading
day.
In
addition, on any date on which we submit a Purchase Notice to Aspire Capital for 100,000 shares and the closing price of our common
stock is not less than the Floor Price per share, we also have the right, in our sole discretion, to present Aspire Capital with
a VWAP Purchase Notice directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the
Company’s common stock traded on the Nasdaq Capital Market on the next trading day, subject to the VWAP Purchase Share Volume
Maximum and the VWAP Minimum Price Threshold. The VWAP Purchase Price is calculated by reference to the prevailing market price
of our common stock (as more specifically described below).
The
Purchase Agreement provides that neither we nor Aspire Capital will effect any sales under the Purchase Agreement on any purchase
date where the closing sale price of our common stock is less than the Floor Price. There are no trading volume requirements or
restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Aspire
Capital. Aspire Capital has no right to require any sales by us, but is obligated to make purchases from us as we direct in accordance
with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future
financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. Aspire Capital
may not assign its rights or obligations under the Purchase Agreement. The Purchase Agreement may be terminated by us at any time,
at our discretion, without any penalty or cost to us.
Purchase
Of Shares Under The Common Stock Purchase Agreement
Under
the terms of the Purchase Agreement, on any trading day selected by us on which the closing sale price of our common stock exceeds
the Floor Price, we may direct Aspire Capital to purchase up to 100,000 shares of our common stock per trading day. The Purchase
Price of such shares is equal to the lesser of:
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the
lowest sale price of our common stock on the purchase date; or |
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the
arithmetic average of the three lowest closing sale prices for our common stock during the ten consecutive trading days ending
on the trading day immediately preceding the purchase date. |
In
addition, on any date on which we submit a Purchase Notice to Aspire Capital for purchase of 100,000 shares and on which the closing
price of our common stock exceeds the Floor Price, we also have the right to direct Aspire Capital to purchase an amount of stock
equal to up to 30% of the aggregate shares of our common stock traded on the Nasdaq Capital Market on the next trading day, subject
to the VWAP Purchase Share Volume Maximum and the VWAP Minimum Price Threshold, which is equal to the greater of (a) 80% of the
closing price of the Company’s common stock on the business day immediately preceding the VWAP Purchase Date or (b) such
higher price as set forth by the Company in the VWAP Purchase Notice. The VWAP Purchase Price of such shares is the lower of:
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the
Closing Sale Price on the VWAP Purchase Date; or |
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97%
of the volume-weighted average price for our common stock traded on the Nasdaq Capital Market: |
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on
the VWAP Purchase Date, if the aggregate shares to be purchased on that date have not exceeded the VWAP Purchase Share Volume
Maximum; or |
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during
that portion of the VWAP Purchase Date until such time as the sooner to occur of (i) the time at which the aggregate shares
traded on the Nasdaq Capital Market exceed the VWAP Purchase Share Volume Maximum or (ii) the time at which the sale price
of the Company’s common stock falls below the VWAP Minimum Price Threshold. |
The
Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction
occurring during the trading day(s) used to compute the Purchase Price. We may deliver multiple Purchase Notices and VWAP Purchase
Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has
been completed.
Minimum
Share Price
Under
the Purchase Agreement, we and Aspire Capital may not effect any sales of shares of our common stock under the Purchase Agreement
on any trading day that the closing sale price of our common stock is less than the Floor Price.
Events
of Default
Generally,
Aspire Capital may terminate the Purchase Agreement upon the occurrence of any of the following, among other, events of default:
|
● |
the
effectiveness of any registration statement that is required to be maintained effective pursuant to the terms of the Registration
Rights Agreement between us and Aspire Capital lapses for any reason (including, without limitation, the issuance of a stop
order) or is unavailable to Aspire Capital for sale of our shares of common stock, and such lapse or unavailability continues
for a period of ten consecutive business days or for more than an aggregate of thirty business days in any 365-day period,
which is not in connection with a post-effective amendment to any such registration statement; in connection with any post-effective
amendment to such registration statement that is required to be declared effective by the SEC such lapse or unavailability
may continue for a period of no more than 40 consecutive business days; |
|
|
|
|
● |
the
suspension from trading or failure of our common stock to be listed on our principal market for a period of three consecutive
business days; |
|
● |
the
delisting of our common stock from our principal market, provided our common stock is not immediately thereafter trading on
the New York Stock Exchange, the NYSE MKT, the Nasdaq Capital Market, the Nasdaq Global Select Market, the Nasdaq Global Market,
the OTB Bulletin Board or the OTCQB marketplace or OTCQX marketplace of the OTC Markets Group; |
|
|
|
|
● |
our
transfer agent’s failure to issue to Aspire Capital shares of our common stock which Aspire Capital is entitled to receive
under the Purchase Agreement within five business days after an applicable purchase date; |
|
|
|
|
● |
any
breach by us of the representations or warranties or covenants contained in the Purchase Agreement or any related agreements
which could have a material adverse effect on us, subject to a cure period of five business days; |
|
|
|
|
● |
if
we become insolvent or are generally unable to pay our debts as they become due; or |
|
|
|
|
● |
any
participation or threatened participation in insolvency or bankruptcy proceedings by or against us. |
Our
Termination Rights
The
Purchase Agreement may be terminated by us at any time, at our discretion, without any penalty or cost to us.
No
Short-Selling or Hedging by Aspire Capital
Aspire
Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect
short-selling or hedging of our common stock during any time prior to the termination of the Purchase Agreement.
Effect
of Performance of the Purchase Agreement on Our Stockholders
The
Purchase Agreement does not limit the ability of Aspire Capital to sell any or all of the 1,577,699 shares registered in this
offering. It is anticipated that shares registered in this offering will be sold over a period of up to approximately 30 months
after this registration statement is declared effective under the Securities Act. The sale by Aspire Capital of a significant
amount of shares registered in this offering at any given time could cause the market price of our common stock to decline and/or
to be highly volatile. Aspire Capital may ultimately purchase all, some or none of the 888,835 shares of common stock not yet
issued but registered in this offering, and it may sell all, some
or none of the shares issued to it by us (including the Initial Purchase Shares, the Commitment Shares and any shares issued to
it in the future). Therefore, sales to Aspire Capital by us pursuant to the Purchase Agreement also may result in substantial
dilution to the interests of other holders of our common stock. However, we have the right to control the timing and amount of
any sales of our shares to Aspire Capital and the Purchase Agreement may be terminated by us at any time at our discretion without
any penalty or cost to us.
Percentage
of Outstanding Shares After Giving Effect to the Purchased Shares Issued to Aspire Capital
In
connection with entering into the Purchase Agreement, we authorized the sale to Aspire Capital of up to $10.0 million of our shares
of common stock, $1.0 million of which were issued to Aspire Capital upon the signing of the Purchase Agreement. The remaining
$9.0 million shares may be sold by us to Aspire Capital over a period of approximately 30 months after this registration statement
is declared effective under the Securities Act. We estimate that we will sell no more than 888,835 additional shares to Aspire
Capital under the Purchase Agreement (exclusive of the 188,864 Commitment Shares and the 500,000 Initial Purchase Shares), all
of which are included in this offering. Subject to any required approval by our board of directors, we have the right but not
the obligation to issue more than the 1,577,699 shares included in this prospectus to Aspire Capital under the Purchase Agreement.
In the event we elect to issue more than 1,577,699 shares under the Purchase Agreement, we will be required to file a new registration
statement and have it declared effective by the SEC. The number of shares ultimately offered for sale by Aspire Capital in this
offering is dependent upon the number of shares purchased by Aspire Capital under the Purchase Agreement. The following table
sets forth the number and percentage of outstanding shares to be held by Aspire Capital after giving effect to the sale of shares
of common stock issued to Aspire Capital at varying purchase prices:
Assumed
Average
Purchase Price | | |
Proceeds
from the
Sale of Additional
Shares to
Aspire Capital Under
the Purchase
Agreement
Registered in this
Offering | | |
Number
of Additional
Shares to be Issued in this Offering at the Assumed Average Purchase Price (1) | | |
Percentage
of
Outstanding Shares
After Giving Effect to the
Purchased Shares Issued
to Aspire Capital (2) | |
$ | 1.50 | | |
$ | 1,333,253 | | |
| 888,835 | | |
| 16.7 | % |
$ | 2.00 | | |
$ | 1,777,670 | | |
| 888,835 | | |
| 16.7 | % |
$ | 2.50 | | |
$ | 2,222,088 | | |
| 888,835 | | |
| 16.7 | % |
$ | 3.00 | | |
$ | 2,666,505 | | |
| 888,835 | | |
| 16.7 | % |
$ | 5.00 | | |
$ | 4,444,175 | | |
| 888,835 | | |
| 16.7 | % |
$ | 10.00 | | |
$ | 8,888,350 | | |
| 888,835 | | |
| 16.7 | % |
$ | 10.13 | | |
$ | 9,000,000 | | |
| 888,450 | | |
| 16.7 | % |
$ | 11.00 | | |
$ | 9,000,000 | | |
| 818,181 | | |
| 16.0 | % |
$ | 15.00 | | |
$ | 9,000,000 | | |
| 600,000 | | |
| 14.0 | % |
(1) |
Excludes
188,864 Commitment Shares and 500,000 Initial Purchase Shares issued under the Purchase Agreement between the Company and
Aspire Capital. |
|
|
(2) |
The
denominator is based on 8,582,009 shares outstanding as of December 30, 2015, which includes the 500,000 Initial Purchase
Shares and 188,864 Commitment Shares previously issued to Aspire Capital plus the potential number of shares we may issue
to Aspire Capital in the future under the Purchase Agreement. |
USE
OF PROCEEDS
This
prospectus relates to shares of our common stock that may be offered and sold from time to time by Aspire Capital. We will not
receive any proceeds upon the sale of shares by Aspire Capital. However, we have received proceeds of $1.0 million, and may receive
additional proceeds up to $9.0 million, for an aggregate of $10.0 million gross proceeds, under the Purchase Agreement with Aspire
Capital. The proceeds received from the sale of the shares under the Purchase Agreement will be used for working capital and general
corporate purposes, including research and development activities. This anticipated use of net proceeds from the sale of our common
stock to Aspire Capital under the Purchase Agreement represents our intentions based upon our current plans and business conditions.
PRICE
RANGE OF COMMON STOCK
Our
common stock began trading on the NASDAQ Capital Market under the ticker symbol “RTTR” on June 24, 2015. Prior to
that date, there was no public market for our common stock. Our initial public offering was priced at $5.00 per share on June
24, 2015. The table sets forth, for the periods indicated below, the high and low intra-day sales prices per share of our common
stock as reported on the New York Stock Exchange since June 24, 2015.
| |
High | | |
Low | |
2015 | |
| | | |
| | |
Second Quarter (beginning June 24, 2015) | |
$ | 5.50 | | |
$ | 3.80 | |
Third Quarter | |
$ | 4.70 | | |
$ | 2.00 | |
Fourth Quarter (through December 30,
2015) | |
$ | 2.63
| | |
$ | 1.61
| |
2016 | |
| | | |
| | |
First Quarter (through January 15, 2016) | |
$ | 1.76 | | |
$ | 1.12 | |
On January
15, 2016, the closing price for our common stock as reported on the NASDAQ Capital Market was $1.33 per
share.
As
of December 30, 2015, we had 47 holders of record of our common stock. The actual number of stockholders is greater than
this number of record holders, and includes stockholders who are beneficial owners but whose shares are held in street name by
brokers and other nominees. The number of record holders also does not include stockholders whose shares may be held in trust
by other entities.
DIVIDEND
POLICY
We
have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our
common stock in the foreseeable future. We intend to retain all available funds and any future earnings to fund the development
and expansion of our business. Any future determination to pay dividends will be at the discretion of our board of directors and
will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual
restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant. See “Risk
Factors — Risks Relating to Our Common Stock and this Offering — We have never paid dividends on our common stock
and do not anticipate paying dividends for the foreseeable future, and accordingly, stockholders must rely on stock appreciation
for any return on their investment.”
DILUTION
The
sale of our common stock to Aspire Capital pursuant to the Purchase Agreement will have a dilutive impact on our stockholders.
As a result, our net income/(loss) per share would decrease/increase in future periods and the market price of our common stock
could decline. In addition, the lower our stock price is at the time we exercise our right to sell shares to Aspire Capital, the
more shares of our common stock we will have to issue to Aspire Capital pursuant to the Purchase Agreement and our existing stockholders
would experience greater dilution.
After
giving effect to (i) the issuance of the 500,000 Initial Purchase Shares for gross proceeds of $1.0 million, (ii) the issuance
of the 188,864 Commitment Shares, and (ii) the sale of 888,835 shares of common stock (the approximate number of
additional shares that can be sold so as not to exceed 19.99%) at an assumed offering price of $1.75 per share (the closing
price of our common stock on December 18, 2015), and after deducting estimated offering expenses of $100,000 payable by us, our
pro forma net tangible book value as of September 30, 2015 would have been $17.9 million, or $1.91 per share of common
stock. This represents an immediate decrease in pro forma net tangible book value of $0.07 per share to our existing shareholders
and an immediate dilution in pro forma net tangible book value of $0.07 per share to investors participating in this offering.
The
following table illustrates this dilution on a per share basis:
Assumed public offering price per share |
|
| |
|
$ | 1.75 | |
Net tangible book value per share as of September 30, 2015 |
|
$ | 1.98 |
|
| | |
Decrease in net
tangible book value per share attributable to this offering |
|
$ | (0.07 |
) |
| | |
Pro forma net tangible book value per
share after this offering |
|
| |
|
$ | 1.91 | |
Dilution per share to investors participating
in this offering |
|
| |
|
$ | 0.07 | |
The
shares sold in this offering, if any, in addition to the 188,864 Commitment Shares and 500,000 Initial Purchase Shares,
may be sold from time to time at various prices.
Each
$1.00 increase in the per share price at which we sell shares to Aspire Capital under the Purchase Agreement from the assumed
offering price of $1.75 per share would increase our pro forma net tangible book value by $0.9 million, our pro
forma net tangible book value per share by $0.095 and dilution per share to new investors purchasing shares of common stock
in this offering by $0.095, assuming that the number of shares of common stock offered, as set forth on the cover page of this
prospectus, remains the same and after deducting estimated aggregate offering expenses payable by us. This information is supplied
for illustrative purposes only.
The
table and calculations set forth above are based on the number of shares of common stock outstanding as of September 30, 2015
and assumes no exercise of any outstanding options or warrants. To the extent that options or warrants are exercised, there will
be further dilution to new investors.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion and analysis of our financial condition and results of operations together with “Selected
Financial Data” and our financial statements and the related notes appearing elsewhere in this prospectus. In addition to
historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and
assumptions. See “Cautionary Statements Regarding Forward-Looking Statements and Industry Data” for a discussion of
the uncertainties and assumptions associated with these statements. Our actual results may differ materially from those discussed
below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and
those discussed in the section titled “Risk Factors” included elsewhere in this prospectus. All common share
amounts and per share amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operation
have been adjusted to reflect the 1-for-7.15 reverse stock split of our common stock effected on June 17, 2015.
Overview
Ritter
Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases.
We are advancing human gut health research by exploring the metabolic capacity of the gut microbiota and translating the functionality
of prebiotic-based therapeutics into applications intended to have a meaningful impact on a patient’s health. We have completed
a Phase 2a clinical trial of our leading product candidate, RP-G28, an orally administered, high purity oligosaccharide.
We
have devoted substantially all of our resources to development efforts relating to RP-G28, including conducting clinical trials
of RP-G28, providing general and administrative support for these operations and protecting our intellectual property. We currently
do not have any products approved for sale and we have not generated any revenue from product sales since our inception. From
our inception through June 28, 2015, we funded our operations primarily through the private placement of preferred stock, common
stock and promissory notes.
On
June 24, 2015, our registration statement on Form S-1 (File No. 333-202924) relating to our initial public offering of our common
stock was declared effective by the SEC. The shares began trading on the NASDAQ Capital Market on June 24, 2015. The initial public
offering closed on June 29, 2015, and 4,000,000 shares of common stock were sold at an initial public offering price of $5.00
per share, for aggregate gross proceeds to us of $20 million.
We
paid to the underwriters underwriting discounts and commissions of approximately $1.6 million in connection with the offering.
In addition, we incurred expenses of approximately $1.0 million in connection with the offering. Thus, the net offering proceeds
to us, after deducting underwriting discounts and commissions and offering expenses, were approximately $17.4 million.
We
have incurred net losses in each year since our inception, including net losses of approximately $6.6 million for the nine months
ended September 30, 2015. We had an accumulated deficit of approximately $24.9 million as of September 30, 2015. Substantially
all our net losses resulted from costs incurred in connection with our research and development programs, stock-based compensation,
and from general and administrative costs associated with our operations.
We
expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We anticipate
that our expenses will increase substantially as we:
|
● |
complete
the development of our lead product candidate, RP-G28, for the reduction of symptoms associated with lactose intolerance in
patients; |
|
|
|
|
● |
seek
to obtain regulatory approvals for RP-G28; |
|
|
|
|
● |
outsource
the commercial manufacturing of RP-G28 for any indications for which we receive regulatory approval; |
|
|
|
|
● |
contract
with third parties for the sales, marketing and distribution of RP-G28 for any indications for which we receive regulatory
approval; |
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|
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|
● |
maintain,
expand and protect our intellectual property portfolio; |
|
|
|
|
● |
continue
our research and development efforts; |
|
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|
|
● |
add
operational, financial and management information systems and personnel, including personnel to support our product development
and commercialization efforts; and |
|
|
|
|
● |
operate
as a public company. |
We
do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing
approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant
uncertainty. Accordingly, we anticipate that we will need to raise additional capital in addition to the net proceeds received
in our initial public offering prior to the commercialization of RP-G28 or any other product candidate. Until such time, if ever,
as we can generate substantial revenue from product sales, we expect to finance our operating activities through a combination
of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements
and other collaborations, strategic alliances and licensing arrangements. However, we may be unable to raise additional funds
or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such
other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our product
candidates.
Financial
Overview
Revenue
We
have not generated any revenue since our inception. Our ability to generate revenue in the future will depend almost entirely
on our ability to successfully develop, obtain regulatory approval for and then successfully commercialize RP-G28 in the United
States. In the event we choose to pursue a partnering arrangement to commercialize RP-G28 or other products outside the United
States, we would expect to initiate additional research and development and clinical trial activities in the future.
Research
and Development Expenses
Since
our inception, we have focused our resources on our research and development activities, including conducting nonclinical studies
and clinical trials, manufacturing development efforts and activities related to regulatory filings for RP-G28. Our research and
development expenses consist primarily of:
|
● |
fees
paid to consultants and CROs, including in connection with our nonclinical and clinical trials, and other related clinical
trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical
trial material management and statistical compilation and analysis; |
|
|
|
|
● |
costs
related to acquiring and manufacturing clinical trial materials; |
|
|
|
|
● |
depreciation
of leasehold improvements, laboratory equipment and computers; |
|
|
|
|
● |
costs
related to compliance with regulatory requirements; and |
|
|
|
|
● |
overhead
expenses for personnel in research and development functions. |
From
inception through September 30, 2015, we have incurred approximately $5.3 million in research and development expenses. We plan
to increase our research and development expenses for the foreseeable future as we continue the development of RP-G28 for the
reduction of symptoms associated with lactose intolerance in patients and other indications, subject to the availability of additional
funding.
The
successful development of our clinical and preclinical product candidates is highly uncertain. At this time, we cannot reasonably
estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of any
of our clinical or preclinical product candidates or the period, if any, in which material net cash inflows from these product
candidates may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty
of:
|
● |
the
scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development
activities; |
|
|
|
|
● |
future
clinical trial results; and |
|
|
|
|
● |
the
timing and receipt of any regulatory approvals. |
A
change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant
change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory
authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion
of clinical development of a product candidate or if we experience significant delays in enrollment in any of our clinical trials,
we could be required to expend significant additional financial resources and time on the completion of clinical development.
RP-G28
The
majority of our research and development resources are focused on the Phase 2b and Phase 3 RP-G28 trials and our other planned
clinical and nonclinical studies and other work needed to submit RP-G28 for the reduction of symptoms associated with lactose
intolerance in patients for regulatory approval in the United States and Europe. We have incurred and expect to continue to incur
expenses in connection with these efforts, including:
|
● |
conduct
our Phase 2b/3 clinical trials as an adaptive design Phase 2b/3 clinical trials; |
|
|
|
|
● |
working
with our CRO to prepare for launch of the Phase 2b/3 and Phase 3 trials; and |
|
|
|
|
● |
working
with our third-party drug formulator to produce sufficient drug product for the adaptive design Phase 2b/3 clinical trials
and other contemplated trials. |
Patent
Costs
Patent
costs consist primarily of professional fees for legal services to prosecute patents and maintain patent rights.
General
and Administrative Expenses
General
and administrative expenses include allocation of facilities costs, salaries, benefits, and stock-based compensation for employees,
professional fees for directors, fees for independent contractors and accounting and legal services.
We
expect that our general and administrative expenses will increase as we operate as a public company and due to the potential commercialization
of RP-G28. We believe that these increases will likely include increased costs for director and officer liability insurance, and
increased fees for outside consultants, lawyers and accountants. We also expect to incur increased costs to comply with corporate
governance, internal controls and similar requirements applicable to public companies.
Interest
Income and Interest Expense
Interest
income consists of interest earned on our cash. We expect our interest income to increase due to the receipt of net proceeds from
our initial public offering as we invest the net proceeds from the offering pending their use in our operations.
Interest
expense pertains to interest accrued on our promissory notes.
Critical
Accounting Policies and Estimates
This
Management’s Discussion and Analysis of our Financial Condition and Results of Operations is based on our financial statements,
which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation
of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities,
revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis,
we evaluate our estimates and judgments, including those related to fair value of financial instruments, research and development
costs, accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events
and various other factors we believe to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results
may differ from these estimates under different assumptions or conditions.
While
our significant accounting policies are more fully described in Note 3 to our financial statements appearing elsewhere in this
prospectus, we believe that the following accounting policies are the most critical for fully understanding and evaluating our
financial condition and results of operations.
Fair
Value of Financial Instruments
FASB
ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell
an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC
820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement
purposes. The estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized
on disposition of the financial instruments.
FASB
ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable
or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market
assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities
(Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
The
three levels of the fair value hierarchy are as follows:
|
Level
1 — |
Quoted
prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement
date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded
instruments and listed equities. |
|
|
|
|
Level 2 —
|
Inputs
other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider
various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial
instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data
or are supported by observable levels at which transactions are executed in the marketplace. |
|
|
|
|
Level 3 —
|
Unobservable
inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using
pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.
|
The
carrying amounts reported in the balance sheet for cash and cash equivalents, prepaid expenses, accounts payable, accrued expenses,
and the notes payable approximate the fair values due to the short-term nature of the instruments.
Research
and Development Costs
We
expense the cost of research and development as incurred. Research and development expenses comprise costs incurred in performing
research and development activities, including clinical study costs, contracted services, and other external costs. Nonrefundable
advance payments for goods and services that will be used in future research and development activities are expensed when the
activity is performed or when the goods have been received, rather than when payment is made, in accordance with ASC 730, Research
and Development.
The
successful development of RP-G28 is uncertain. At this time, other than as discussed below, we cannot reasonably estimate the
nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of RP-G28 or the period,
if any, in which material net cash inflows from the sale of RP-G28 may commence. This is due to the numerous risks and uncertainties
associated with developing product candidates, including those described in “Risk Factors” in this prospectus. Development
timelines, probability of success and development costs vary widely. As a result of these risks and uncertainties, we cannot currently
estimate with any degree of certainty the amount of time or money that will be required to expend in the future on the research
and development of RP-G28.
Accrued
Expenses
As
part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves
reviewing quotations and contracts, identifying services that have been performed on our behalf and estimating the level of service
performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual
cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones
are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and
circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make
adjustments if necessary. The significant estimates in our accrued research and development expenses include fees due to service
providers.
We
base our expenses on our estimates of the services received and efforts expended pursuant to quotes and contracts with our service
providers that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation,
vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors
will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service
fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period.
If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual accordingly.
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status
and timing of services performed relative to the actual status and timing of services performed may vary and could result in us
reporting amounts that are too high or too low in any particular period.
Stock-based
Compensation
In
June 2015, we adopted a new equity incentive plan, or the 2015 Equity Incentive Plan, to replace our prior 2008 Stock Plan and
2009 Stock Plan. Terms of our share-based compensation are governed by the 2015 Equity Incentive Plan, 2009 Stock Plan and 2008
Stock Plan, or collectively the Plans. The Plans permit us to grant non-statutory stock options, incentive stock options and other
equity awards to our employees, outside directors and consultants; however, incentive stock options may only be granted to our
employees. Beginning June 29, 2015, no further awards may be granted under the 2009 Stock Plan or 2008 Stock Plan. As of September
30, 2015, the aggregate number of shares of common stock available for issuance under the 2015 Equity Incentive Plan was 206,448.
However, to the extent awards under the 2008 Plan or 2009 Plan are forfeited or lapse unexercised or are settled in cash, the
common stock subject to such awards will be available for future issuance under the 2015 Equity Incentive Plan.
The
exercise price for options issued under the Plans is determined by our Board of Directors, but will be (i) in the case of an incentive
stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the
fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value
per share on the date of grant; and (ii) in the case of a nonstatutory stock option, no less than 100% of the fair market value
per share on the date of grant. The options awarded under the Plans shall vest as determined by our Board of Directors but shall
not exceed a ten-year period.
Options
Issued to Directors and Employees as Compensation
We
recognize compensation costs related to stock options granted to employees based on the estimated fair value of the awards on
the date of grant, net of estimated forfeitures. We estimate the grant date fair value, and the resulting stock-based compensation
expense, using the Black-Scholes option-pricing model. The grant date fair value of stock-based awards is expensed on a straight-line
basis over the vesting period of the respective award. Performance-based awards vest and are expensed over the performance period
when the related performance goal is probable of being achieved.
Pursuant
to the terms of the Plans, from inception to December 31, 2013, we issued options to purchase an aggregate of 206,172 shares to
our executive officers and employees. The exercise prices of these option grants, as determined by our Board of Directors, range
from $0.79 to $1.27 per share, and a portion of these vest subject to certain performance conditions. In addition, we granted
additional non-qualified 10-year term options to our executive officers to purchase an aggregate of 1,790,540 shares of our common
stock in December 2014. As of December 31, 2014, an aggregate of 82,107 options were expired or exercised, and an aggregate of
1,914,605 issued to executive officers and employees options remained outstanding.
During
the nine months ended September 30, 2015, no additional options were granted and an aggregate of 41,958 options to purchase our
common stock were automatically terminated due to certain performance conditions not being met. As of September 30, 2015, we had
a total of 1,872,647 options issued to our executive officers and employees outstanding.
We
recognized stock based compensation expense for these services within general and administrative expense of approximately $2.4
million and $2,500 for the nine months ended September 30, 2015 and 2014, respectively. As of September 30, 2015, there was approximately
$2.4 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements. This cost is
expected to be recognized over a weighted average period of 1.6 years.
In
addition to annual cash compensation payable to certain non-employee directors for their services on the Board and its committees,
the Board of Directors determined to award certain non-employee directors an option to acquire 10,000 shares of our common stock
to vest 25% upon the first anniversary of the nonemployee director’s approximate date of joining the Board of Directors
with the remaining options vesting monthly in equal amounts over 36 months. As of September 30, 2015, no stock based compensation
had been granted to the nonemployee directors.
Options
Issued to Non-Employees for Service Received
We
account for stock-based compensation arrangements with non-employees using a fair value approach. The fair value of these options
is measured using the Black-Scholes option-pricing model reflecting the same assumptions as applied to employee options in each
of the reported periods, other than the expected life, which is assumed to be the remaining contractual life of the option. The
compensation costs of these arrangements are subject to re-measurement over the vesting terms as earned.
From
inception to September 30, 2015, we had issued options to our consultants to purchase an aggregate of 106,573 shares of our common
stock under the Plans. Of these, 73,985 options were forfeited or exercised, and 32,588 options remain outstanding as of September
30, 2015. The exercise prices of the outstanding options, as determined by our board of directors, range from $0.72 to $1.14 per
share. These outstanding options, with the exception of an option to purchase an aggregate of 7,271 shares granted to a consultant,
vest 25% upon the first anniversary of the vesting commencement date with the remaining options vesting monthly in equal amounts
over 36 months. In March 2011, we granted an option to a consultant to purchase an aggregate of 7,271 shares with an exercise
price of $1.00 which vests 25% on the date of grant with the remaining options vesting monthly in equal amounts over 36
months. We recognized stock based compensation expense for these services of approximately $700 and $1,000 for the nine months
ended September 30, 2015 and 2014, respectively, within research and development expense.
Option
Valuation
We
calculate the fair value of stock-based compensation awards granted to employees and nonemployees using the Black-Scholes option-pricing
method. If we determine that other methods are more reasonable, or other methods for calculating these assumptions are prescribed
by regulators, the fair value calculated for our stock options could change significantly. Higher volatility and longer expected
lives would result in an increase to stock-based compensation expense to non-employees determined at the date of grant. Stock-based
compensation expense to non-employees affects our general and administrative expenses and research and development expenses.
The
Black-Scholes option-pricing model requires the use of highly subjective and complex assumptions, which determine the fair value
of stock-based awards. The assumptions used in the Black-Scholes option-pricing method for the nine months ended September 30,
2015 and 2014 are set forth below:
| |
Nine
months ended September 30, | |
| |
2015 | | |
2014 | |
Expected dividend yield | |
| 0.00 | | |
| 0.00 | |
Expected stock-price volatility | |
| 51.45%
- 67.08 | % | |
| 55.32%
- 64.24 | % |
Risk-free interest rate | |
| 0.77%
- 2.07 | % | |
| 0.94%
- 3.04 | % |
Expected term of options | |
| 10 | | |
| 10 | |
Stock price | |
$ | 5.86 | | |
$ | 1.17
- $5.86 | |
|
● |
Expected
dividend. The expected dividend is assumed to be zero as we have never paid dividends and have no current plans to pay
any dividends on our common stock. |
|
|
|
|
● |
Expected
volatility. As our common stock only recently became publicly traded, the expected volatility is derived from the average
historical volatilities of publicly traded companies within our industry that we consider to be comparable to our business
over a period approximately equal to the expected term. |
|
|
|
|
● |
Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero
coupon U.S. Treasury notes with maturities approximately equal to the expected term. |
|
|
|
|
● |
Expected
term. The expected term represents the period that the stock-based awards are expected to be outstanding. Our historical
share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a
lack of sufficient data. Therefore we estimate the expected term by using the simplified method provided by the SEC. The simplified
method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. |
In
addition to the assumptions used in the Black-Scholes option-pricing model, we also estimate a forfeiture rate to calculate the
stock-based compensation for our equity awards. We will continue to use judgment in evaluating the expected volatility, expected
terms and forfeiture rates utilized for our stock-based compensation calculations on a prospective basis.
Significant
factors, assumptions and methodologies used in determining the estimated fair value of the Company’s common stock
We
are also required to estimate the fair value of the common stock underlying our stock-based awards when performing the fair value
calculations using the Black-Scholes option-pricing model. Our Board of Directors, with the assistance of management, determined
the fair value of our common stock on each grant date. Option grants are based on the estimated fair value of our common stock
on the date of grant, which is determined by taking into account several factors, including the following:
|
● |
the
prices at which we sold our convertible preferred stock and the rights, preferences, and privileges of the convertible preferred
stock relative to those of our common stock, including the liquidation preferences of the convertible preferred stock; |
|
|
|
|
● |
important
developments in our operations; |
|
|
|
|
● |
our
actual operating results and financial performance; |
|
|
|
|
● |
conditions
in our industry and the economy in general; |
|
|
|
|
● |
stock
price performance of comparable public companies; |
|
|
|
|
● |
the
estimated likelihood of achieving a liquidity event, such as an IPO or an acquisition, given prevailing market conditions;
and |
|
|
|
|
● |
the
illiquidity of the common stock underlying stock options. |
The
table below presents the prices received from sales to third parties of our common stock and various classes of our preferred
stock from inception to date:
Year | |
Share
Class | |
Price
per Share | |
2005 | |
Common Stock(a) | |
$ | 1.79 | |
2006 | |
Series A-2 Preferred Stock(a)(b)
| |
$ | 0.40 | |
2008 – 2009 | |
Series A-3 Preferred Stock(b)
| |
$ | 0.62 | |
2010 – 2013 | |
Series B Preferred Stock(b)
| |
$ | 1.19 | |
2014 | |
Series C Preferred Stock(b)
| |
$ | 1.30 | |
(a) |
After
giving effect to our conversion from an LLC to a corporation. |
|
|
(b) |
Each
share of preferred stock is convertible into shares of our common stock on a 7.15-for-1 basis, after giving effect to the
reverse stock split effected June 17, 2015. |
For
options issued from inception to November 7, 2013, in determining the estimated fair value of our common stock, our Board of Directors,
with the assistance of management, used the market approach to estimate the enterprise value of the Company in accordance with
the American Institute of Certified Public Accountants (“AICPA”) Accounting and Valuation Guide, Valuation of Privately-Held
Company Equity Securities Issued as Compensation (the “AICPA Guide”) for the three valuation dates of November 7,
2013, July 31, 2012, and December 31, 2010. The Market Approach is one of the three approaches (along with the Income Approach
and Asset Approach) used to estimate enterprise and equity value. The market approach employs analysis using comparable companies
in determining the value of the entity. Both public and private companies, if publicly available information exists, are considered
in the market approach. Two information points commonly available – company valuation and transaction value — are
used for their respective methodologies. There are a number of different methods within the Market Approach that may be used:
the three main methods utilized are: the Guideline Pubic Companies Method; the Guideline Transactions Method; and the Backsolve
Method.
Given
the early stage of our company, the Backsolve Method was used to estimate the fair value of our securities. This method derives
an implied market value of invested capital from a transaction involving a company’s own securities. The price of a company’s
security that was involved in a recent arms-length transaction is used as a reference point in an allocation of value. We first
raised additional capital through the sales of our LLC units. These units later converted into common shares and preferred shares
upon our conversion to a corporation. Subsequent to our corporation conversion, we raised additional capital through the sales
of our Series A-1, Series A-2, Series A-3, Series B, and Series C preferred shares at the price of $0.07, $0.40, $0.62,
$1.19, and $1.30, respectively.
We
valued LLC units and common stock (after converting to a corporation) from inception through 2009 by reference to our sales of
units and/or common stock and preferred stock over the period. Beginning in 2010, we valued our common stock using the Backsolve
Method. The Backsolve Method requires considering the rights and preferences of each class of equity and solving for the total
market value of invested capital that is consistent with a recent transaction in our own securities, considering the rights and
preferences of each class of equity. However, our management has decided that the liquidation preferences between our preferred
shares and common shares are immaterial for a pre-revenue company.
Per
the AICPA Guide, the Backsolve Method is generally the most reliable indicator of value of early-stage enterprises with no product
revenue or cash flow, if relevant and reliable transactions have occurred in the company’s equity securities. This methodology
is also prescribed by the AICPA when a valuation is conducted in close proximity to the date of a financing transaction, and when
other methodologies are deemed less reliable.
The
stage of development of our compound was reflected in our selection of the term and volatility estimates used in the analysis.
The estimate of the term considers our existing cash runway and the time to the next potential financing or liquidity event, while
the volatility estimate reflects the relative riskiness of our equity securities (or asset base) relative to the general stock
market.
Our
management estimated the implied market value of invested capital of our company by backsolving for the purchase price of our
preferred shares for one common share through the option-pricing method. The premise of this method is that the transaction implied
a market price for a share which in turn implied values for the other classes of equity based on relative claims on equity value,
such as liquidation preferences and conversion rights. The application of the backsolve method considering our capital structure
yielded a total market value of invested capital of approximately $15.5 million, $14.4 million, and $8.9 million, of which approximately
$819,000, $870,000, and $670,000 were allocated to the total value of common stock as of our three valuation dates of November
7, 2013, July 31, 2012, and December 31, 2010, respectively.
On
the three valuation dates of November 7, 2013, July 31, 2012, and December 31, 2010, after estimating the market value of invested
capital, we allocated it to the various equity classes comprising our capitalization table. This process ultimately results in
creating a final estimate of value for our underlying equity interests. While there are many different value allocation methods,
these various methods can be grouped into three general categories as defined by the AICPA Guide, one of which is the Option-Pricing
Method (OPM).
We
used the OPM to allocate market value of invested capital to the various equity classes and debt comprising our capitalization
structure. We chose the OPM over other acceptable methods due to the complex capital structure of our company, the uncertainty
related to market conditions, and the lack of visibility on an imminent exit event. Under the OPM, each equity class is modeled
as a call option with a distinct claim on the equity of our company. The option’s exercise price is based on our company’s
total equity value available for each participating equity holder. The characteristics of each equity class determine the equity
class’ claim on the total equity value. By constructing a series of options in which the exercise price is set at incremental
levels of value, which correspond to the equity value necessary for each level of equity to participate, we determined the incremental
option value of each series. When multiplied by the percentage of ownership of each equity class participating under that series,
the result is the incremental value allocated to each class under that series.
The
OPM relies on the Black-Scholes option-pricing model to value the call options on our invested capital. The following inputs were
applied in the Black-Scholes calculations of the OPM:
| |
Valuation
Date | |
| |
November
7, 2013 | | |
July
31, 2012 | | |
December
31, 2010 | |
Risk-free rate | |
| 0.55 | % | |
| 0.57 | % | |
| 2.01 | % |
Maturity (years) | |
| 3.00 | | |
| 4.00 | | |
| 5.00 | |
Volatility | |
| 58.00 | % | |
| 61.00 | % | |
| 61.00 | % |
Discounts
ranging from 35.8% to 40% were applied for lack of control and lack of marketability for the common stock. The calculation resulted
in a fair value for the common stock of $1.17, $1.19, and $1.03 per share as of our three valuation dates of November
7, 2013, July 31, 2012, and December 31, 2010, respectively.
For
options issued in 2014, given our distinct possible exit scenarios of an initial public offering, we used the probability weighted
expected return method (PWERM) to estimate the fair value of our common equity. Under this method, an analysis of future values
of a company is performed for several likely liquidity scenarios. The value of the common stock is determined for each scenario
at the time of each future liquidity event and discounted back to the present using a risk-adjusted discount rate. The present
values of the common stock under each scenario are then weighted based on the probability of each scenario occurring to determine
the value for the common stock. Our management determined the probability weighting of potential liquidity events to be 45% for
an initial public offering and 55% for other scenarios, which represents all other likely outcomes for our company.
Management
estimated the implied market value of invested capital of our company by backsolving for the purchase price of our preferred shares
for one common share through the use of OPM. The application of the backsolve method considering our capital structure yielded
a total market value of invested capital of approximately $25.2 million, of which approximately $1.4 million was allocated to
the total value of common stock as of our valuation date of October 31, 2014.
Given
the lack of marketability for the common stock, we applied a discount of 21.4% for using the average strike put option approach.
This resulted in a probability weighted common share value, after adjustment, of $5.86 per share as of valuation date
of October 31, 2014.
Stock-based
Compensation Summary Tables
Information
regarding our stock option grants to our employees and non-employees, along with the estimated fair value per share of the underlying
common stock, for stock options granted since 2005 is summarized as follows:
Grant
Date | |
Number
of Common
Shares Underlying
Options Granted | | |
Exercise
Price
per Common Share | | |
Estimated
Fair Value
per Share of
Common Stock | | |
Intrinsic
Value
Option | |
2005 | |
| 58,321 | | |
$0.07 | | |
$ | 1.79 | | |
| $1.72 | |
2009 | |
| 60,559 | | |
$0.72 – $0.79 | | |
$ | 4.43 | | |
| $3.71
– $3.64 | |
2011 | |
| 33,846 | | |
$1.00 | | |
$ | 1.00 | | |
| $0.00 | |
2012 | |
| 60,019 | | |
$1.14 | | |
$ | 1.14 | | |
| $0.00 | |
2013 | |
| 100,000 | | |
$1.14
– $1.30 | | |
$ | 1.14 | | |
| $0.00 | |
2014 | |
| 1,626,740 | | |
$5.86
– $13.23 | | |
$ | 5.86 | | |
| $0.00 | |
The
following represents a summary of the options granted to employees and non-employees outstanding at September 30, 2015 and changes
during the period then ended:
| |
Options | | |
Weighted
Average Exercise Price | |
Outstanding at December 31, 2014 | |
| 1,952,516 | | |
$ | 7.022 | |
Granted | |
| — | | |
| — | |
Exercised/Expired/Forfeited | |
| (47,281 | ) | |
| (1.249 | ) |
Outstanding at September 30, 2015 | |
| 1,905,235 | | |
$ | 7.165 | |
Exercisable at September 30, 2015 | |
| 584,960 | | |
$ | 5.202 | |
Expected to be
vested | |
| 1,320,275 | | |
$ | 8.034 | |
JOBS
Act
On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can
take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (the
Securities Act), for complying with new or revised accounting standards. In other words, an “emerging growth company”
can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have
elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of
the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective
dates for public and private companies until those standards apply to private companies. As a result of this election, our financial
statements may not be comparable to companies that comply with public company effective dates.
We
are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the
JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely
on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system
of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any
requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report
providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth
anniversary of the date we completed our initial public offering, which was June 29, 2015, (b) in which we have total annual gross
revenue of at least $1.0 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value
of our common stock that is held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (ii) the
date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
Results
of Operations
Comparison
of the Nine Months Ended September 30, 2015 and 2014
The
following table summarizes our results of operations for the nine months ended September 30, 2015 and 2014, together with the
changes in those items in dollars and as a percentage:
| |
For
the Nine Months Ended
September 30, | | |
Dollar | | |
Percentage | |
| |
2015 | | |
2014 | | |
Change | | |
Change | |
Statement of Operations
Data: | |
| | | |
| | | |
| | | |
| | |
Operating costs
and expenses | |
| | | |
| | | |
| | | |
| | |
Research
and development | |
$ | 1,584,086 | | |
$ | 69,161 | | |
$ | 1,514,925 | | |
| 2,190 | % |
Patent costs | |
| 160,033 | | |
| 94,055 | | |
| 65,978 | | |
| 70 | % |
General
and administrative | |
| 4,860,676 | | |
| 763,388 | | |
| 4,097,288 | | |
| 537 | % |
Total
operating costs and expenses | |
| 6,604,795 | | |
| 926,604 | | |
| 5,678,191 | | |
| 613 | % |
Loss from operations | |
| (6,604,795 | ) | |
| (926,604 | ) | |
| (5,678,191 | ) | |
| 613 | % |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest income
(expense), net | |
| 23,157 | | |
| (17,210 | ) | |
| 40,367 | | |
| 235 | % |
Other
income | |
| 16,682 | | |
| — | | |
| 16,682 | | |
| | |
Total
other income (expense) | |
| 39,839 | | |
| (17,210 | ) | |
| 57,049 | | |
| 331 | % |
Net
Loss | |
$ | (6,564,956 | ) | |
$ | (943,814 | ) | |
$ | (5,621,142 | ) | |
| 596 | % |
Research
and Development Expenses
Research
and development expenses were approximately $1.6 million and $70,000 for the nine months ended September 30, 2015 and 2014, respectively.
The increase in research and development expenses of approximately $1.5 million, or 2,190%, primarily reflects our manufacturing
ramp-up costs to prepare product for clinical trials.
Patent
Costs
Patent
costs were approximately in $160,000 and $94,000 for the nine months ended September 30, 2015 and 2014, respectively, representing
an increase of $66,000, or 70%. This increase was primarily due to our transition to a new service provider.
General
and Administrative Expenses
General
and administrative expenses were approximately $4.9 million and $800,000 for the nine months ended September 30, 2015 and 2014,
respectively. The increase in general and administrative expenses is $4.1 million, or 537%. This increase in general and administrative
expenses was primarily due to the increase in stock based compensation related to the options granted to our executives and employees
in December 2014, increase in headcount and in salary for our officers in 2015, and the increase in expenses related to the closing
of our initial public offering.
Other
Income
The
increase in net interest income was approximately $40,000, or 235%. Net interest income for the nine months ended September 30,
2015 was approximately $23,000, which was primarily a result of increased cash resulting from the net proceeds of our initial
public offering. Net interest expense for the nine months ended September 30, 2014 was approximately $17,000, which primarily
represented interest costs associated with our outstanding promissory notes.
Other
income was $16,682 and $0 for the nine months ended September 30, 2015 and 2014, respectively. The increase of $16,682 was a result
of a gain on the settlement of accounts payable.
Comparison
of the Year Ended December 31, 2014 and the Year Ended December 31, 2013
The
following table summarizes our results of operations for the years ended December 31, 2014 and 2013, together with the changes
in those items in dollars and as a percentage:
| |
For
the Year Ended
December 31, | | |
Dollar | | |
Percentage | |
| |
2014 | | |
2013 | | |
Change | | |
Change | |
Statement of Operations
Data: | |
| | | |
| | | |
| | | |
| | |
Operating costs
and expenses | |
| | | |
| | | |
| | | |
| | |
Research
and development | |
$ | 113,931 | | |
$ | 461,551 | | |
$ | (347,620 | ) | |
| (75 | )% |
Patent costs | |
| 197,731 | | |
| 292,358 | | |
| (94,627 | ) | |
| (32 | )% |
General
and administrative | |
| 1,969,960 | | |
| 1,356,888 | | |
| 613,072 | | |
| 45 | % |
Total
operating expenses | |
| 2,281,622 | | |
| 2,110,797 | | |
| 170,825 | | |
| 8 | % |
Loss from operations | |
| (2,281,622 | ) | |
| (2,110,797 | ) | |
| (170,825 | ) | |
| 8 | % |
Other expense (income): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| (525 | ) | |
| (1,677 | ) | |
| 1,152 | | |
| (69 | )% |
Interest expense | |
| 213,516 | | |
| 6,076 | | |
| 207,440 | | |
| 3,414 | % |
Other
income | |
| (21,148 | ) | |
| (19,365 | ) | |
| (1,783 | ) | |
| 9 | % |
Total
other expense (income) | |
| 191,843 | | |
| (14,966 | ) | |
| 206,809 | | |
| (1,382 | )% |
Net
Loss | |
$ | (2,473,465 | ) | |
$ | (2,095,831 | ) | |
$ | (377,634 | ) | |
| 18 | % |
Research
and Development Expenses
Research
and development expenses were approximately $114,000 and $462,000 for the years ended December 31, 2014 and 2013, respectively.
The decrease in research and development expenses of approximately $348,000, or 75%, primarily reflects our preparation work for
our Type C meeting with the FDA in 2013, including the assistance of clinical, medical and biostatistician consultants in data
analyses. This work was largely completed in 2013, and therefore the observed decrease in research and development expense reflects
the discontinuation of their services.
Patent
Costs
Patent
costs were approximately in $198,000 and $292,000 for the years ended December 31, 2014 and 2013, respectively, representing a
decrease of $95,000, or 32%. This decrease was primarily due to Patent Cooperation Treaty, or PCT, filings, which took
place in 2013. We incurred no significant PCT costs in 2014.
General
and Administrative Expenses
General
and administrative expenses were approximately $2.0 million and $1.4 million for the years ended December 31, 2014 and 2013, respectively.
The increase in general and administrative expenses is $613,000 or 45%. This increase in general and administrative expenses was
primarily due to the salary for our new Chief Executive Officer starting in October 2014, and the increase in stock based compensation
related to the options granted to our executives and employees in 2014, partially offset by a reduction in our staffing of independent
contractors and public relations effort in 2014.
Other
Income (Expense)
Interest
expense, net of interest income was approximately $213,000 and $4,000 for the years ended December 31, 2014 and 2013, respectively.
The increase of approximately $209,000 in net interest expense was primarily a result of a non-cash charge of approximately $184,000
related to the conversion of convertible promissory notes in December 2014 and interest costs associated with convertible promissory
notes used to finance our operations in 2014.
Liquidity
and Capital Resources
Sources
of Liquidity
Since
our inception, we have incurred net losses and negative cash flows from operations, and, as of September 30, 2015, we had an accumulated
deficit of approximately $24.9 million. Substantially all our net losses resulted from costs incurred in connection with our research
and development programs, stock-based compensation, and from general and administrative costs associated with our operations.
At
September 30, 2015, after consummation of our initial public offering, we had working capital of $15.4 million, and cash of $16.2
million. We have not generated any product revenues and have not achieved profitable operations.
Cash
Flows
The
following table sets forth the significant sources and uses of cash for the periods set forth below:
| |
For
the Year Ended
December 31, | | |
For
the Nine Months Ended
September 30, | |
| |
2014 | | |
2013 | | |
2015 | | |
2014 | |
Net cash used in: | |
| | | |
| | | |
| | | |
| | |
Operating
activities | |
$ | (1,157,385 | ) | |
$ | (1,956,914 | ) | |
$ | (4,302,569 | ) | |
$ | (886,543 | ) |
Investing activities | |
| (1,166 | ) | |
| (8,692 | ) | |
| (10,100 | ) | |
| (1,166 | ) |
Financing
activities | |
| 3,457,573 | ) | |
| 643,995 | ) | |
| 17,810,162 | | |
| 439,483 | |
Net
decrease in cash | |
$ | 2,299,022 | | |
$ | (1,321,611 | ) | |
$ | 13,497,493 | | |
$ | (448,226 | ) |
Operating
Activities
Net
cash used in operating activities of approximately $4.3 million during the nine months ended September 30, 2015 was primarily
a result of our net loss of approximately $6.6 million, offset by stock based compensation of approximately $2.4 million and an
increase in prepaid and other assets of approximately $251,000 and a decrease in accounts payable and accrued expenses of approximately
$343,000.
Net
cash used in operating activities of approximately $887,000 during the nine months ended September 30, 2014 was primarily a result
of our net loss of approximately $944,000 and an increase of approximately $50,000 in prepaid and other assets, offset by an increase
in accounts payable and accrued expenses of approximately $95,000.
Net
cash used in operating activities of approximately $1.2 million during the year ended December 31, 2014 was primarily a result
of our net loss of approximately $2.5 million offset by stock based compensation of approximately $707,000 and a non-cash charge
of approximately $184,000 to interest expense related to the conversion of convertible promissory notes and an increase of approximately
$249,000 in accounts payable and an increase in accrued expenses of approximately $160,000.
Net
cash used in operating activities of approximately $2.0 million during the year ended December 31, 2013 was primarily a result
of our net loss of approximately $2.1 million, offset by an increase of approximately $120,000 in accounts payable.
Investing
Activities
Net
cash used in investing activities of approximately $10,000 during the nine months ended September 30, 2015 was primarily a result
of our purchasing office furniture and equipment.
Net
cash used in investing activities of approximately $1,000 during the year ended December 31, 2014 primarily reflected our use
of cash to purchase equipment, offset partially by our proceeds from the disposal of property and equipment. Net cash used in
investing activities during the year ended December 31, 2013 of approximately $9,000 primarily reflected our use of cash to purchase
equipment.
Financing
Activities
Net
cash provided by financing activities of approximately $17.8 million during the nine months ended September 30, 2015 resulted
from net proceeds received upon closing of our initial public offering, selling 4,000,000 shares of our common stock offset partially
by commissions and issuance costs of approximately $2.2 million.
Net
cash provided by financing activities during the nine months ended September 30, 2014 of $455,000 resulted from proceeds borrowed
under notes payable, partially offset by repayment of a note payable of $27,000.
Net
cash provided by financing activities of approximately $3.5 million in the year ended December 31, 2014 mainly resulted from approximately
$3.0 million in net proceeds received on sales of preferred stock subject to redemption and warrants to purchase common stock
and approximately $605,000 in net proceeds from the sale of convertible notes offset partially by deferred offering costs of approximately
$143,000.
Net
cash provided by financing activities in the year ended December 31, 2013 of approximately $644,000 resulted from net proceeds
from the issuance of shares of Series B preferred stock and issuance of a prepaid forward sale contract on shares of Series B
preferred stock.
Future
Funding Requirements
To
date, we have not generated any revenue. We do not know when, or if, we will generate any revenue from product sales. We do not
expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize
RP-G28 or any of our other product candidates. At the same time, we expect our expenses to increase in connection with our ongoing
development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval
for, our product candidates. We have incurred and will continue to incur costs associated with operating as a public company that
we did not incur as a private company. In addition, subject to our obtaining regulatory approval for any of our product candidates,
we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate
that we will need substantial additional funding in connection with our continuing operations.
Based
upon our current operating plan, we believe that our existing cash and cash equivalents, together with interest, and the net proceeds
from our sale of shares to Aspire Capital pursuant to the Purchase Agreement will enable us to fund our operating expenses and
capital expenditure requirements through the first quarter of 2017. We intend to devote our existing financial resources to fund
the continued clinical development of RP-G28 for the reduction of symptoms associated with lactose intolerance, including our
anticipated Phase 2b/3 trials; to fund expenses associated with the manufacture and product development of RP-G28; to explore
potential orphan indications; and for general corporate purposes, general and administrative expenses, capital expenditures, working
capital and prosecution and maintenance of our intellectual property.
Our
future capital requirements will depend on many factors, including:
|
● |
the
progress, costs, results of and timing of implementing a Phase 2b/3 clinical trials for the reduction of symptoms associated
with lactose intolerance in patients; |
|
|
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the
willingness of the EMA or other regulatory agencies outside the United States to accept our Phase 2b/3 and any Phase 3 trials
of RP-G28, as well as our other completed and planned clinical and nonclinical studies and other work, as the basis for review
and approval of RP-G28 in the European Union for the reduction of symptoms associated with lactose intolerance in patients;
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● |
the
outcome, costs and timing of seeking and obtaining FDA, EMA and any other regulatory approvals; |
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● |
the
number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;
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● |
the
ability of our product candidates to progress through clinical development successfully; |
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● |
our
need to expand our research and development activities; |
|
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● |
the
costs associated with securing and establishing commercialization and manufacturing capabilities; |
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● |
market
acceptance of our product candidates; |
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● |
the
costs of acquiring, licensing or investing in businesses, products, product candidates and technologies; |
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● |
our
ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of
any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense
and enforcement of any patents or other intellectual property rights; |
|
● |
our
need and ability to hire additional management and scientific and medical personnel; |
|
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● |
the
effect of competing technological and market developments; |
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● |
our
need to implement additional internal systems and infrastructure, including financial and reporting systems; |
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● |
the
economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or
other arrangements into which we may enter in the future; and |
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the
costs of operating as a public company. |
Until
such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination
of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements
and other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through
the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the
terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders.
Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific
actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through
government or other third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic
alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future
revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
Contractual
Obligations and Commitments
Lease
Agreement
Until
September 30, 2015, we leased office and storage space for our headquarters in California pursuant to a two-year agreement which
called for a minimum monthly rent of approximately $5,000 and an annual increase of 3%. Rent expense, recognized on a straight-line
basis, was approximately $45,000 in each of the nine months ended September 30, 2015 and 2014 and approximately $60,000 and $79,000
for each of the years ended December 31, 2015 and 2014, respectively. Rent expense is recorded in salaries, general and administrative
expenses in the Unaudited Condensed Statements of Operations.
On
July 9, 2015, we entered into a new lease with Century Park, pursuant to which we are leasing approximately 2,780 square feet
of office space in Los Angeles, California for our headquarters. The lease provides for a term of sixty-one (61) months, which
commenced October 1, 2015. We paid no rent for the first month of the term and will pay base rent of $9,174 per month for months
2 through 13 of the term, with increasing base rent for each twelve month period thereafter under the term of the lease to a maximum
of $10,325 per month for months 50 through 61. We have the option to extend the term of the lease for one five-year term, provided
that the rent would be subject to market adjustment at the beginning of the renewal term.
Employment
Agreements
Michael
Step
On
December 2, 2014, Michael Step accepted an offer letter from us setting forth the terms of his employment as Chief Executive Officer.
The offer letter provides that Michael Step is entitled to an annual base salary of $360,000 and a total of three grants of options
to purchase our common stock.
The
first two options entitle Michael Step to purchase 646,537 and 73,777 of our shares, respectively, for an exercise price of $5.86
per share. Each of these options was immediately exercisable in full as of the date of the grant, with 44/48ths of the total number
of shares covered by each option subject to a right of repurchase by us upon termination of Michael Step’s employment with
us for any reason. This right of repurchase lapses over a period of 44 months, with 1/44th of the total number of shares subject
to the right of repurchase lapsing on January 1, 2015 and on the first day of each month thereafter. In addition, the right of
repurchase will lapse in its entirety upon a termination of the employment under certain circumstances.
The
third option became exercisable upon the closing of our initial public offering on June 29, 2015. The option is for a total of
163,799 shares of our common stock, which, together with the shares subject to the first option, represents 7.5% of the shares
of common stock deemed to be outstanding at June 29, 2015 on a fully-diluted basis after giving effect to the number of shares
subject to the third option. Seventy-five percent (75%) of the shares subject to the third option are subject to a right of repurchase
by us upon termination of Michael Step’s employment for any reason. This right of repurchase lapses with respect to 1/36th
of the total number of shares subject to the right of repurchase on the first day of each month following the date on which the
third option became exercisable. In addition, the right of repurchase will lapse in its entirety upon Michael Step’s termination
of employment under certain circumstances.
Additionally,
under the terms of his Executive Severance and Change in Control Agreement, also effective on December 2, 2014, Michael Step is
entitled to receive certain payments in the event his employment is terminated under certain scenarios.
Andrew
Ritter and Ira Ritter
On
September 25, 2013, our Board of Directors approved the Executive Compensation Plan, or the Compensation Plan, setting forth certain
compensation to be paid to Andrew Ritter, our current President and former Chief Executive Officer, and Ira Ritter, our current
Chief Strategic Officer, or CSO, for their contributions to our company. Effective June 29, 2015, in connection with our initial
public offering, Andrew Ritter and Ira Ritter accepted offer letters from us setting forth the terms of their employment as President
and CSO, respectively, of the Company.
Their
respective offer letters provide that that Andrew Ritter is entitled to an annual base salary of $310,000 and Ira Ritter is entitled
to an annual base salary of $295,000. In accordance with his offer letter, Andrew Ritter also became entitled to receive up to
$180,000 payable over a three-year period for tuition reimbursement. As of September 30, 2015, we paid an aggregate of $60,000
and accrued $92,500 in tuition reimbursement for Andrew Ritter and recognized such amount in general and administrative expenses
in the accompanying Unaudited Condensed Statements of Operations in the three and nine month periods ending September 30, 2015.
Additionally,
under the terms of their Executive Severance and Change in Control Agreements, also effective on June 29, 2015, Andrew Ritter
and Ira Ritter are entitled to receive certain payments in the event their employment is terminated under certain scenarios.
Pursuant
to their respective offer letters, Andrew Ritter and Ira Ritter each have the opportunity to earn an annual bonus based upon a
percentage of their base salary and the achievement of specific performance as determined by the Company. The initial target bonus
opportunities are 40% and 35% of the base salary for Andrew Ritter and Ira Ritter, respectively.
Pursuant
to the Compensation Plan, as in effect prior to entering into their offer letters, Andrew Ritter and Ira Ritter had bonus opportunities
to, upon the satisfaction of the events described below, each potentially receive the following cash payments and each potentially
receive the following options to purchase up to 48,951 shares of our common stock, or the Executive Options:
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FDA
Meeting Bonus Opportunities. Each executive was entitled to receive, and in April 2013 each executive received, a one-time
cash bonus of $10,000 for a milestone associated with meeting with the FDA regarding RP-G28’s path to FDA approval.
In addition, upon satisfaction of this milestone, the executives became entitled to 3,496 of the Executive Options. 2,360
shares of the Executive Options vested and became exercisable as of the grant date of September 25, 2013, with the balance
of the 1,136 shares vesting ratably in 36 equal monthly installment beginning on September 30, 2013. |
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Clinical
Trial Funding Commitment Bonus Opportunities. Each executive was entitled to receive a one-time cash bonus of
$75,000 upon our receipt of a commitment by a third party to fund a Phase 2 or later clinical trial; provided, however, that
no such bonus would be paid at any time we had less than $2,000,000 in available cash. In addition, upon the satisfaction
of this milestone, 35% of 10,489 shares of the Executive Options would vest and become exercisable, with the balance of the
10,489 shares vesting in 36 equal monthly installments beginning on the last day of the following month. The Board of Directors
determined that this milestone was satisfied; accordingly, each executive received a bonus of $75,000, which has been recognized
in general and administrative expenses in the accompanying Unaudited Condensed Statements of Operations in the nine month
periods ending September 30, 2015. In addition, 3,671 shares of the Executive Options vested and became exercisable as of
June 29, 2015, with the balance of 6,818 shares vesting ratably on a monthly basis beginning July 31, 2015. |
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Fundraising
Bonus Opportunities. Each executive was entitled to receive (i) a one-time cash bonus of $50,000 upon the sale
of additional equity capital for cash, in one or more closings after July 17, 2012, and/or the actual deployment of funds
by a third party for a clinical trial in an aggregate amount in excess of $2,000,000 and (ii) a one-time cash bonus
of $150,000 upon the sale of additional equity capital for cash, in one or more closings after July 17, 2012 and/or
the actual deployment of funds by a third party for a clinical trial in an aggregate amount in excess of $10,000,000 (which
such bonus would be reduced by any cash bonus paid under subsection (i)); provided, however, that no bonus under subsection
(i) or (ii) would be paid at any time we had less than $2,000,000 in available cash. In addition, upon the satisfaction of
the milestone described in subsection (i), 35% of 6,993 shares of the Executive Options would vest and become exercisable,
with the balance of the 6,993 shares vesting in 36 equal monthly installments beginning on the last day of the following month,
and, upon satisfaction of the milestone described in subsection (ii), 35% of 13,986 shares of the Executive Options would
vest and become exercisable, with the balance of the 13,986 shares vesting in 36 monthly installments beginning on the last
day of the following month. The Board of Directors determined that this milestone as described in subsection (ii) above was
satisfied upon the closing of our initial public offering on June 29, 2015 raising approximately $17.4 million, net of offering
costs; accordingly, each executive received a bonus of $150,000 which has been recognized in general and administrative expenses
in the accompanying Unaudited Condensed Statements of Operations in the nine month periods ending September 30, 2015. In addition,
4,895 shares of the Executive Options vested and became exercisable as of June 29, 2015, with the balance of 9,091 shares
vesting ratably on a monthly basis beginning July 31, 2015. |
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License
Event Bonus Opportunities. Each executive was entitled to receive the following bonus payments in connection with the
closing of an exclusive license of RP-G28 and/or any future product candidate developed by the Company from time to time during
the term of the Compensation Plan by and/or any option to exclusively license such product candidate to a third party (referred
to under the Compensation Plan as a “License Event”) with a minimum upfront payment to the Company of
$2,000,000: |
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●
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A
graduated cash bonus equal to (i) 5% of the Initial Period License Payment (as defined in the Compensation Plan) up to $5,000,000;
(ii) 4% of the Initial Period License Payment in excess of $5,000,000 up to $10,000,000; and (iii) 3% of the Initial
Period License Payment in excess of $10,000,000. In addition, upon our receipt of an Initial Period License Payment of more
than $2,000,000, 35% of 45,454 shares of their Executive Options will vest and become exercisable, with the balance of the
45,454 shares vesting in 36 monthly installments beginning on the last day of the following month. |
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●
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A
cash bonus equal to 3% of any Annual Excess Milestone Payments (as defined in the Compensation Plan); provided, however that
no such bonus may be paid at any time the Company has less than $1,000,000 in available cash. In addition, upon our receipt
of an Annual Excess Milestone Payment, 35% of 6,993 shares of their Executive Options will vest and become exercisable, with
the balance of the 6,993 shares vesting in 36 monthly installments beginning on the last day of the following month. |
As
of September 30, 2015, 27,972 of the maximum 48,951 Executive Options potentially issuable to each executive had been issued to
each executive subject to the vesting conditions described above.
Research
and Development Arrangements
Clinical
Supply and Cooperation Agreement with Ricerche Sperimentali Montale and Inalco SpA
Effective
July 24, 2015, we entered into a second amendment to the Clinical Supply and Cooperation Agreement, or the Supply Agreement, with
Ricerche Sperimentali Montale SpA, or RSM, and Inalco SpA, or Inalco, dated December 16, 2009, and amended September 25, 2010.
Under
the Supply Agreement, RSM granted us an exclusive worldwide option in a specified field and territory to assignment of all right,
title and interest to a purified Galacto-oligosaccharides product, or Improved GOS, the composition of matter of the Improved
GOS and any information relating to the Improved GOS, including certain specified technical information and other intellectual
property rights, or the Improved GOS IP. Pursuant to the second amendment to the Supply Agreement, we could exercise the option
by paying RSM $800,000 within ten days after the effective date of the amendment. We exercised the option on July 30, 2015 and
RSM transferred the Improved GOS IP to us. Under the terms of the Supply Agreement, if a further option payment due in the future
is not made, we may be required to return the Improved GOS IP to RSM.
The
second amendment to the Supply Agreement also provides that we must pay RSM $400,000 within 10 days following FDA approval of
a new drug application for the first product owned or controlled by us using Improved GOS as its active pharmaceutical ingredient.
In addition, we agreed to purchase 350 kilos of Improved GOS for the sum of $250 per kilo for clinical supply of Improved GOS
instead of $2,000 per kilo as under the Supply Agreement.
Under
the terms of, and in consideration for RSM entering into, the second amendment to the Supply Agreement, we were to issue 100,000
shares of our common stock, or the RSM Shares, to RSM. The RSM Shares were issued pursuant to a stock purchase agreement, dated
as of November 30, 2015. The stock purchase agreement includes a lock-up agreement by RSM in favor of us pursuant to which RSM
will not be able to sell the RSM Shares for a period ending on the earlier of (i) the public release by us of the final results
of our Phase 2b/3 clinical trial of RP-G28 and (ii) the filing of our Form 10-Q with the Securities and Exchange Commission for
the fiscal quarter in which we receive the results of our Phase 2b/3 clinical trial of RP-G28.
We
recognized the agreement for 100,000 shares issuance to RSM as a fully prepaid forward sale contract on our common stock. The
fully prepaid forward sale contract is a hybrid instrument comprising (1) a debt host instrument and (2) an embedded forward sale
contract, requiring us to issue 100,000 shares of our common stock for no further consideration. Fair value of these shares as
of effective date of the agreement totaling $416,000 was recognized in stockholders’ equity in the Condensed Balance Sheet
as of September 30, 2015.
Master
Service Agreement with Covance Inc.
On
December 30, 2015, we entered into a Master Service Agreement with Covance Inc., or Covance, with an effective date of December
29, 2015. Pursuant to the terms of the Master Service Agreement, Covance (or one or more of its affiliates) will provide Phase
I/II/II/IV clinical services for a clinical study or studies to us, and, at our request, assist us with the design of such studies,
in accordance with the terms of separate individual project agreements to be entered into by the parties. The term of the agreement
is for three years and will renew automatically for successive one year periods unless Covance is no longer providing services
under the agreement or either party has terminated the agreement upon written notice.
Off-Balance
Sheet Arrangements
We
did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements as defined under SEC
rules.
Recent
Accounting Pronouncements
In
June 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-10, Development
Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest
Entities Guidance in Topic 810, Consolidation. This ASU removes the definition of a development stage entity from the ASC, thereby
removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP. In
addition, the ASU eliminates the requirements for development stage entities to (1) present inception-to-date information in the
statements of operations, cash flows, and stockholders’ equity, (2) label the financial statements as those of a development
stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose
in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development
stage. In addition, ASU 2014-10 requires an entity that has not commenced principal operations to provide disclosures about the
risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those
activities are being directed toward. This ASU is effective for annual reporting periods beginning after December 15, 2014, and
interim periods therein. Early adoption is permitted. The Company has elected to adopt this ASU and its adoption resulted in the
removal of previously required development stage disclosures. Adoption of this ASU enabled the Company to eliminate the cumulative
statements of operations and statements of cash flows information, which did not impact the Company’s financial position,
operations, or cash flows.
In
August 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-15, Presentation
of Financial Statements — Going Concern (Subtopic 205-40) — Disclosure of Uncertainties
about an Entity’s Ability to Continue as a Going Concern, which provides guidance regarding management’s responsibility
to assess whether substantial doubt exists regarding the ability to continue as a going concern and requires related footnote
disclosures. In connection with preparing financial statements for each annual and interim reporting period, management should
evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to
continue as a going concern within one year after the date that the financial statements are issued (or within one year after
the date that the financial statements are available to be issued when applicable). This ASU is effective for the annual period
ending after December 15, 2016, and for annual periods and interim periods thereafter. Management is currently evaluating the
new guidance and has not determined the impact this standard may have on our financial statements.
BUSINESS
Our
Business
Ritter
Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases.
We are advancing human gut health research by exploring the metabolic capacity of the gut microbiota and translating the functionality
of prebiotic-based therapeutics into applications intended to have a meaningful impact on a patient’s health.
Our
first novel microbiome modulator, RP-G28, an orally administered, high purity galacto-oligosaccharide, is currently under development
for the reduction of symptoms associated with lactose intolerance. RP-G28 is designed to stimulate the growth of lactose-metabolizing
bacteria in the colon, thereby effectively adapting the gut microbiome to assist in digesting the lactose that reaches the large
intestine. RP-G28 has the potential to become the first FDA-approved drug for the reduction of symptoms associated with lactose
intolerance. RP-G28 has been studied in a Phase 2a clinical trial and is a first-in-class compound.
The
Gut Microbiome
The
human gut is a relatively under-explored ecosystem but provides a great opportunity for using dietary intervention strategies
to reduce the impact of gastrointestinal disease. The human body carries about 100 trillion microorganisms in the intestines,
which is 10 times greater than the number of cells in the human body. This microbial population is responsible for a number of
beneficial activities such as fermentation, strengthening the immune system, preventing growth of pathogenic bacteria, providing
nutrients, and providing hormones. Recent major initiatives such as the Human Microbiome Project (HMP) by the National Institutes
of Health have further validated the significance of the microbial population that exists in our bodies. Publications on the gut
microbiome have increased from less than 50 papers annually in 2004 to more than 1,300 today [PubMed Search “Gut Microbiome”
(2013)]. The increasing knowledge of how these microbial populations impact human health provides opportunities for novel
therapies to treat an assortment of diseases such as neurological disease, cardiovascular disease, obesity, irritable bowel syndrome,
inflammatory bowel disease, colon cancer, allergies, autism and depression.
Platform
Approach
Our
platform is based on selectively colonizing microbiota (increasing beneficial bacteria) in the colon, and thus changing the colon’s
composition of microbiota. The process has been shown to stimulate the growth of endogenous bifidobacteria, which after a short
feeding period become predominant in the colon [Gibson. Dietary Modulation of the Human Colonie Microbiota: Introducing the
Concept of Prebiotics. J. Nutr. 125: 1401-1412, 1995]. The result is believed to reduce inflammation and improve digestion,
thereby potentially reducing digestive symptoms.
RP-G28
selectively increases colonization of lactose-metabolizing bacteria in the colon, such as bifidobacteria and lactobacilli, without
increasing the growth of harmful bacteria, such as Escherichia coli, or E. coli. Increased colonization of lactose-metabolizing
colonic microbiota is associated with increased lactase activity, thereby increasing the fermentation of lactose into galactose,
glucose and short chain fatty acids. We believe this process could reduce lactose-derived gas production and thereby mitigate
the symptoms of lactose intolerance.
Lactose
Intolerance
Lactose
intolerance is a widespread condition affecting over one billion people worldwide and over 40 million people in the United States
(or 15% of the U.S. population), with an estimated nine million of those individuals demonstrating moderate to severe symptoms
[NIH Consensus Statement, LIH, Vol. 27, #2 (February 2010); Objective Insights, “Market Research Analysis and Forecasts
on Lactose Intolerance and RP-G28,” p. 4 and 7 (June 2012)].
Current
annual spending on over-the-counter lactose intolerance aids in the United States has been estimated at approximately $2.45 billion
[Zpryme Research & Consulting, “The Digestive Health Prescription Drug Market,” (May 2009)]. However, these
options are limited and there is no long-term treatment available.
Lactose
intolerance develops in lactose maldigesters when consuming too much lactose or when lactose is added to a previously low-lactose
diet. People with lactose maldigestion have a low activity level of lactase, the enzyme responsible for breaking down human lactose,
located in the brush border membrane of the small intestine. Lactose intolerance is characterized by one or more of the cardinal
symptoms; including abdominal pain/cramps, bloating, gas, and diarrhea following the ingestion of lactose or lactose-containing
foods.
In
lactose maldigesters, unhydrolyzed lactose passes into the large intestine, where it is fermented by the indigenous microflora
into gases and short chain fatty acids. The excessive gas production and the osmotic effects of excessive undigested lactose cause
the symptoms of lactose intolerance [Jiang T, Mastapha A, Savaiano DA, Improvement of lactose digestion in humans by ingestion
of unfermented milk containing Biofidobacterium longum, J Dairy Sci. 1996; 79:750-757]. Symptoms begin about 30 minutes to
two hours after eating or drinking foods containing lactose. The severity of symptoms depends on many factors, including the amount
of lactose a person can tolerate and a person’s age, ethnicity, and digestion rate [Lomer MC, Parkes GC, Sanderson JD,
Review article: lactose intolerance in clinical practice — myths and realities, Aliment Pharmacol Ther. 2008; 27(2):93-103;
National Digestive Diseases Information Clearinghouse (NDDIC), Lactose intolerance, http://digestive.niddk.nih.gov/ddiseases/pubs/lactoseintolerance/].
The symptoms of lactose intolerance are caused by gases and toxins produced by anaerobic bacteria in the large intestine. The
problem of lactose intolerance has been exacerbated because many foods and drinks contain traces of lactose without lactose being
clearly stated on the product’s label [Jiang T, Mastapha A, Savaiano DA, Improvement of lactose digestion in humans by
ingestion of unfermented milk containing Biofidobacterium longum, J Dairy Sci. 1996; 79:750-757]. According to the American
Academy of Pediatrics Committee on Nutrition (2006), “the symptoms of lactose intolerance can lead to significant discomfort,
disruption of the quality of life, and loss of school attendance, leisure and sports activities, and work time, all at a cost
to individuals, families and society.”
Diagnosis
Lactose
intolerance is often diagnosed by evaluating an individual’s clinical history, which reveals a relationship between lactose
ingestion and onset of symptoms. Hydrogen breath tests may also be utilized to diagnose lactose malabsorption and a milk challenge
may be used to differentiate between lactose malabsorption and lactose intolerance. Further tests can be conducted to rule out
other digestive diseases or conditions, including: stool examination to document the presence of a parasite, blood tests to determine
the presence of celiac disease, and intestinal biopsies to determine mucosal problems leading to malabsorption, such as inflammatory
bowel disease or ulcerative colitis.
Health
Consequences
Substantial
evidence indicates that lactose intolerance is a major factor in limiting calcium intake in the diet of individuals who are lactose
intolerant. These individuals avoid milk and dairy products, resulting in an inadequate intake of calcium and significant nutritional
and health risks [Alaimo K., McDowell M.A., Briefel R.R., et al., Dietary intake of vitamins, minerals, and fiber of persons
ages 2 months and over in the United States: Third National Health and Nutrition Examination Survey, Phase 1, 1988-91, Adv. Data,
1994;(258):1-28; and Kranz S., Lin P.J., Wagstaff D.A., Children’s dairy intake in the United States: too little, too fat?,
J Pediatr. 2007; 151(6):642-6.]
Dairy
foods account for 73% of the calcium available in the U.S. food supply and 51% of the total intake [Gerrior S, Bente L., Nutrient
content of the U.S. food supply, 1909-94, Washington DC: U.S. Department of Agriculture, Center for Nutrition Policy and Promotion;
1997, Home Economics Research Report No. 53; and Weinberg L.G., Berber L.A., Groves J.E., Nutrient contributions of dairy foods
in the United States, Continuing Survey of Food Intakes by Individuals, 1994-1996, 1998., J Am Diet Assoc., 2004; 104(6):895-902.]
Research
shows that lactose intolerant individuals have a higher prevalence and risk for osteoporosis, hypertension, decreased bone mineral
density and several cancers, including colon and breast cancer from the lack of milk consumption [McCarron D.A., Heaney, R.P.,
Estimated healthcare savings associated with adequate dairy food intake, Am J Hypertens. 2004; 17 (1):88-97; Szilagyi A, Nathwani
U, Vinokuroff C., et al., The effect of lactose maldigestion on the relationship between dairy food intake and colorectal cancer:
a systematic review, Nutr Cancer. 2006; 55(2):141-150; and Suarez F.L., Adshead J., Furne J.K. and Levitt M.D., Amer. J Clin.
Nutrition. 1998; 68:1118-22].
Decreased
Calcium Intake Increases the Risk for Hypertension
Over
30 published reports show that chronic calcium depletion may lead to increased arterial blood pressure. Many additional papers
have corroborated this relationship between hypertension and a low calcium intake [Millen BE, Quatromoni PA, Nam BH, et al.
Framingham Nutrition Studies. Dietary Patterns, Smoking, and Subclinical Heart Disease in Women: Opportunities for Primary Prevention
from the Framingham Nutrition Studies. J Amer Dietetic Assoc. 2004; 104:208-214].
A
growing body of evidence indicates that a nutritionally sound diet rich in fruits, vegetables and a generous component of low-fat
dairy foods, or DASH diet, is optimal for reducing the risk of hypertension [Conlin, P. R., Chow, D., Miller, E. R., 3rd, Svetkey,
L. P., Lin, P. H., Harsha, D. W., et al. (2000), The effect of dietary patterns on blood pressure control in hypertensive patients:
results from the Dietary Approaches to Stop Hypertension (DASH) trial. Am J Hypertens, 13(9), 949-955]. Several recent reports
have confirmed this finding in middle-aged and elderly women [Wang, L, Manson, J, Buring, J, Lee, I-M, Sesso, D. Dietary Intake
of Dairy Products, Calcium, and Vitamin D and the Risk of Hypertension in Middle-Aged and Older Women Hypertension 2008; 51:1073].
Further, it appears that the DASH diet with generous low-fat dairy is associated with low prevalence of metabolic syndrome. The
levels of dairy foods (three-four servings per day) required to achieve these effects are well above current U.S. averages and
even further above that of lactose intolerant individuals who are avoiding dairy due to symptoms [Lovelace, H.Y. and Barr,
S.I., Diagnosis, symptoms, and calcium intakes of individuals with self-reported lactose intolerance, Journal of the American
College of Nutrition, 24(1), 51-57, 2005; Carroccio, A., Montalto, G., et al., Lactose intolerance and self-reported milk intolerance:
relationship with lactose maldigestion and nutrient intake, Journal of the American College of Nutrition, 17, 631-636, 1998; and
Mainguet, P., Faille, I., et al., Lactose intolerance, calcium intake and osteopenia, Lancet, 338, 1156-1157, 1991.
Decreased
Calcium Intake Increases the Risk for Colon and Breast Cancers
A
national symposium as long ago as 1993 reported that there was a relationship between dietary calcium and both colon and breast
cancer. Clearly, several other factors are involved, and the role of calcium has not yet been fully elucidated from the others.
Nonetheless, there is evidence of a relationship [Barger-Lux, M.J. and Heaney, R.P., The role of calcium intake in preventing
bone fragility, hypertension and certain cancers, Journal of Nutrition, 124, 1406S-1411S, 1994].
Our
History
We
were formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC. Our first prototype,
Lactagen™, was an alternative lactose intolerance treatment method. In 2004, clinical testing was conducted,
which included a 60 subject double-blind placebo controlled clinical trial. The results were published in the Federation of American
Societies for Experimental Biology in May 2005 and demonstrated Lactagen™ to be an effective and safe product
for reducing symptoms for nearly 80% of the clinical participants who were on Lactagen™.
The
following four years were devoted to operations, launching marketing efforts in various distribution channels, developing an online
storefront (www.Lactagen.com) and establishing production and fulfillment partners. Our focus was on testing the market
potential for an alternative lactose intolerance treatment method. Extensive efforts were established to track and evaluate customer
experiences with email, direct mail and telecommunication programs. Marketing funds were used to launch radio and television ads,
as well as expand online marketing outreach.
In
2008, we expanded our focus by developing a prescription drug development program. We initiated the program by developing RP-G28,
a second generation edition of Lactagen™. We believe that RP-G28 enables us to state stronger claims, garner
more medical community support and reach a wider market in the effort to treat lactose intolerance. Extensive efforts during this
period focused on assembling highly regarded regulatory, clinical, medical and manufacturing personnel, as well as conducting
technical, regulatory and market analysis to prepare for the FDA approval process.
To
help fund the development of RP-G28, we were awarded a grant from the United States government’s Health Care Bill program,
the Qualifying Therapeutic Discovery Project, or QTDP, in 2008. The grant program provides support for innovative projects that
are determined by the U.S. Department of Health and Human Services to have reasonable potential to result in new therapies that
treat areas of unmet medical need and/or prevent, detect or treat chronic or acute diseases and conditions.
On
September 16, 2008, we converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc.
By
2009, over 15,000 customers had purchased Lactagen™ and we had accumulated a database of the names of over 75,000
sufferers.
By
the end of 2009, we successfully secured a GMP compliant manufacturer and produced RP-G28 drug supplies. We successfully filed
our Investigational New Drug, or IND, Application for RP-G28 to be able to move into Phase 2 studies in June 2010. In December
2010, we took Lactagen™ off the market to solely focus on our drug development efforts.
In
June 2011, we began a Phase 2a clinical trial on RP-G28 to validate the efficacy, safety, and tolerance of RP-G28 compared to
placebo when administered to subjects with symptoms of lactose intolerance. The clinical results from the study, which concluded
at the end of 2011, showed that RP-G28 improved lactose digestion versus placebo as measured by the improvement in digestive symptoms
associated with lactose intolerance and decline in hydrogen production present in a hydrogen breath test. See the section below
entitled “Clinical and Regulatory” for additional information regarding our Phase 2a clinical trial.
Our
Leading Product Candidate — RP-G28
Overview
RP-G28
is a novel highly purified galacto-oligosaccharide, or GOS, which is synthesized enzymatically. The product is being developed
to reduce the symptoms and frequency of episodes of abdominal pain associated with lactose intolerance. The therapeutic is taken
orally (a powder solution mixed in water) for 30 consecutive days. The proposed mechanism of action of RP-G28 is to increase the
intestinal growth and colonization of bacteria that can metabolize lactose to compensate for a patients intrinsic inability to
digest lactose. Once colonization of bacteria has occurred, it is hypothesized that patients will continue to tolerate lactose
as long as they maintain their microflora balance. RP-G28 has the potential to become the first FDA-approved drug for the reduction
of symptoms associated with lactose intolerance.
Galacto-oligosaccharides
(GOS)
RP-G28
is a >95% purified GOS product. GOS refers to a group of compounds containing β-linkages of 1 to 6 galactose units with
a single glucose on the terminal end and are found at low levels in human milk. GOS products resist hydrolysis by salivary and
intestinal enzymes because of the configuration of their glycosidic bonds and reach the colon virtually intact. The undigested
GOS enhances the growth of beneficial, lactose metabolizing, colonic bacteria that already exist in the subject’s digestive
track, including multiple species and strains of bifidobacteria and lactobacilli. Once colonies of these bacteria have increased,
continued lactose exposure should maintain tolerability of lactose without further exposure to RP-G28.
The
significance of a higher purity GOS, namely RP-G28, was highlighted in a 2010 study by Klaenhammer. The in vitro study concluded
that RP-G28 promoted growth of lactobacilli and bifidobacteria, but did not promote multiple strains of E. coli. In contrast,
lower purity GOS stimulated both bifidobacteria as well as the strains of E. coli evaluated. (As seen below in Figure 2, NCK 430
(e. coli) grew in the presence of low purity GOS (GOS 2). Alternatively, the higher purity GOS (RP-G28/GOS 1) did not promote
the growth of E. coli.).
Figure
2
Mechanism
of Action
RP-G28
selectively increases colonization of lactose-metabolizing bacteria in the colon, such as bifidobacteria and lactobacilli, without
increasing the growth of harmful bacteria, such as E. coli. Increased colonization of lactose-metabolizing colonic bacteria
is associated with increased lactase activity and GOS utilization, thereby increasing the fermentation of lactose into galactose,
glucose and short chain fatty acids. Digestion of lactose reduces lactose-derived gas production and thereby mitigates the symptoms
of lactose intolerance.
![](http://www.sec.gov/Archives/edgar/data/1460702/000149315216006847/img_67.jpg)
Safety
& Toxicology of GOS
Clinical
studies of GOS products were reviewed as part of the safety evaluation to support the IND for RP-G28. The safety of GOS products
in humans has been evaluated in 486 adults at doses of 2.5 to 15 gm/day for up to 14 weeks, 342 children at doses of 2.0 –
2.4 gm/day for up to 1 year, and in 2415 newborns and infants for up to 6 months. Overall, no reports of severe adverse events
attributable to the consumption of GOS were reported in the literature.
Among
the studies that included tolerance endpoints, side effects were limited to reports of flatulence, fullness, GI symptoms, and
changes in stool consistency and frequency when GOS was consumed on a repeat basis at quantities of between 5.5 to 15 g/day (Ito
1990; Deguchi 1997; Teuri 1998); however, this effect was not consistently reported in all studies (Teuri and Korpela 1998; Depeint
2008; Drakoularako 2010; van de Heuval 1998; van Dokkum 1999; Bouhnik 2004; Sairanen and Piirainen 2007; Shadid 2007). Similar
observations of increased flatulence have been reported following the consumption of fructooligosaccharides (15 gm/day) over a
7-day period (Alles 1996), and this symptom represents a localized effect that is expected in association with the consumption
of indigestible fiber in large quantities. There were no reports of events in other System Organ Class (SOC) suggestive of systemic
toxicity.
RP-G28
Clinical Safety
In
addition to the nonclinical studies evaluating GOS products, the safety of RP-G28 for clinical investigation is supported by clinical
safety results from the recently completed Phase 2a study, G28-001. In this study, RP-G28 was escalated from 1.5 grams per day
to 15 grams per day over a 35-day dosing period.
RP-G28
was well-tolerated. There were no serious adverse effects. The most common adverse effects were headache, dizziness, nausea, upper
respiratory tract infection, nasal congestion and pain. All adverse effects were mild or moderate in severity, and event occurrence
was distributed over the treatment and post-treatment follow-up phase. No clinically significant changes or findings were noted
from clinical lab evaluations, vital sign measurements, physical exams, or 12-lead electrocardiograms.
Our
Market Opportunity
Unmet
Medical Needs
Lactose
intolerance is a challenging condition to manage. Not only can symptoms be painful and embarrassing, they can also dramatically
affect one’s quality of life, social activities, and health. Currently there are few reliable, or effective, treatments
available that provide consistent or satisfactory relief. According to a market research study conducted by Objective Insights
in April 2012, approximately 60% of lactose intolerant sufferers reported experiencing symptoms daily, or bi-weekly [Objective
Insights, “Market Research Analysis and Forecasts on Lactose Intolerance and RP-G28,” June 2012.]
Over
75% of patients modify their diets, and 80% of patients have reported altering their daily activities, to better manage their
lactose intolerance symptoms [Objective Insights, “Market Research Analysis and Forecasts on Lactose Intolerance and
RP-G28,” June 2012]. According to the American Academy of Pediatrics Committee on Nutrition (2006), “the symptoms
of lactose intolerance can lead to significant discomfort, disruption of the quality of life, and loss of school attendance, leisure
and sports activities, and work time, all at a cost to individuals, families and society.”
Currently,
there is no approved prescription treatment for lactose intolerance. Most persons with lactose intolerance avoid ingestion of
milk and dairy products while others substitute non-lactose-containing foods in their diet. However, complete avoidance of lactose-containing
foods is difficult to achieve (especially for those with moderate to severe symptoms) and can lead to significant long-term morbidity,
i.e., dietary deficiencies of calcium and vitamin D.
At
the 2010 National Institute of Health, or NIH, Consensus Development Conference: Lactose Intolerance and Health, the NIH highlighted
numerous health risks tied to lactose intolerance such as: osteoporosis; hypertension; and low bone density [Such F., Brannon
P., Varpenter T., et al. NIH Consensus Development Conference Statement: Lactose Intolerance and Health, 2010: 1-27]. There
is substantial evidence indicating that lactose intolerance is a major factor in limiting calcium and nutrient intake in the diet
of people who are lactose intolerant. Adequate calcium intake is essential to reducing the risks of osteoporosis and hypertension
[McCarron and Heaney (2004)]. In addition, chronic calcium depletion has been linked to increased arterial blood pressure,
thereby establishing a relationship between hypertension and a low calcium intake [Karania et al. (1994)]. Moreover, there
is evidence of a correlation between calcium intake and both colon and breast cancer [Objective Insights, “Market Research
Analysis and Forecasts on Lactose Intolerance and RP-G28,” June 2012].
Over
50% of lactose intolerant patients are very concerned that they may be susceptible to one of these health risks, as a result of
their lactose intolerance [Objective Insights, “Market Research Analysis and Forecasts on Lactose Intolerance and RP-G28,”
(June 2012)].
Treatment
Options
Doctors
generally recommend the following treatments for the management of lactose intolerance: (1) dairy avoidance; (2) lactase supplements;
(3) probiotics/dietary supplements; and (4) dairy substitutes/lactose free products. Despite educating their patients on all viable
treatment options, physicians tend to advise their patients to refrain from consuming any dairy products whatsoever. However,
47% of lactose intolerance sufferers report that this method is not effective. Further, only 30% of lactose intolerance sufferers
report lactase supplements are effective in managing their lactose intolerance [Survey conducted by Engage Health in May – June
2008]. These statistics suggest that the majority of lactose intolerance patients are dissatisfied with current treatment
options.
Patients
Unsatisfied with Current Management Options
Dairy
Avoidance
Lactose
intolerance has had a dramatic effect on peoples’ lifestyles. Although the most utilized approach to date has been the avoidance
of dairy products, this approach fails to realize that it is not always easy to discern the foods that contain milk, milk products,
or other dairy ingredients. Despite closely monitoring everything they eat, lactose intolerance sufferers are still at risk of
symptoms due to hidden dairy products in ingredients. To avoid any possible embarrassing or physically painful episode, lactose
intolerance sufferers may choose to avoid restaurants, going out, traveling, and limit their social interactions.
Lactase
Supplements
A
wide variety of nutritional supplements are sold to reduce symptoms of lactose intolerance, but there is few rigorous clinical
data to substantiate their benefit. Lactase supplements are taken to aid in the digestion of dairy products. The supplements act
as an enzyme replacement, supplying consumers with lactase, the enzyme necessary to break down lactose. These supplements must
be taken prior to ingestion of dairy products. Consequently, consumers are forced to carry lactase supplements with them. These
pills do not work consistently and dosages can be difficult to determine because dairy foods have varying amounts of lactose.
For example, the most widely used supplement in the United States is Lactaid®, which has been marketed for over
30 years to people with symptoms of lactose intolerance. Lactaid® is commonly used in conjunction with dairy avoidance
or lactose-free products. Depending on the amount of lactose consumed, patients may need to ingest five or more pills a day to
manage their symptoms of lactose intolerance. As a result, enzyme supplementation is an adjunct to, not a substitute for, dietary
dairy restriction. In 2008, 32% of lactose intolerant sufferers reported often or occasional use of lactase supplements, compared
to only 22% reporting usage of these supplements five years ago. These findings suggest that there is a need for a tolerable
and convenient medical treatment that allows for normal intake of milk and dairy product consumption in people with lactose intolerance.
Probiotics/Dietary
Supplements
There
are many complementary products that can be taken to help reduce gastrointestinal symptoms, and/or promote digestive health in
general. Included in this category are probiotics and digestive enzymes. These products are not specifically marketed for lactose
intolerance; rather they are directed towards general gastrointestinal symptoms.
Probiotics
help to increase “friendly flora” in the digestive tract by aiding in proper bowel function, easing digestion, and
reducing overall digestive distress. Probiotic consumption over the past ten years has dramatically increased as many yogurt manufacturers
are starting to promote and market its benefits.
Digestive
enzymes are considered indirect options because lactose intolerant sufferers may opt to consume such products in place of lactase
supplements. Digestive supplements mainly aid and support one’s digestive system, helping break down general foods consumed,
but don’t directly help with lactose intolerance.
Dairy
Substitutes/Lactose-Free Products
Dairy-free
and lactose-free dairy products allow lactose intolerant sufferers the ability to enjoy the benefits of dairy without suffering
symptoms. Dairy substitutes are items that do not contain lactose, but instead contain a substitute such as soy or rice. Lactose-free
and dairy-free products are easier for lactose intolerant individuals to digest because lactose sugar is taken out of the product
or lactase enzymes are added enabling easier digestion.
Most
dairy products can now be found in a “dairy-free” alternative, including milk, ice cream, cheese, butter, creams,
yogurt and milk chocolate. Although these products are available in stores, they are rarely found in restaurants, and are hard
to find while traveling. Moreover, the taste tends to be different than their original counterparts, and they tend to be more
expensive.
Growing
Awareness
Lactose
intolerance is a condition that continues to expand as society advances and evolves. Education and awareness have increased, and
the American diet has greatly changed over the past decade to include more dairy-based goods. As the populace is growing older,
the prevalence of lactose intolerance is increasing because more people tend to develop lactose intolerance later in life. Increased
education and diagnosis is making more people aware of their allergies and digestive conditions. Physicians may compound the growth
of lactose intolerance prevalence and its associated disorders by recommending individuals to avoid dairy products, a practice
which in and of itself may increase severity of the intolerance.
At
least 75% of lactose intolerance patients would like to see a treatment, and believe that it is “very important” to
find an adequate and satisfactory treatment [Objective Insights, “Market Research Analysis and Forecasts on Lactose Intolerance
and RP-G28” (June 2012)]. Results from a recent market survey study indicate that 54% of respondents suffering from
moderate symptoms would likely ask their physician for a prescription [Engage Health Inc., “Market Potential for an Rx
and Nutritional Supplement Product for Lactose Intolerance in the US” (June 2008)]. Additionally, 61% of individuals
suffering from severe lactose intolerance symptoms would be likely to ask their physician for treatment [Engage Health Inc.,
“Market Potential for an Rx and Nutritional Supplement Product for Lactose Intolerance in the US” (June 2008)]. These
results suggest that the need for treatment increases with the severity of a patient’s symptoms.
Physician
Awareness
Doctors
report that there is an unmet need in the current reduction of symptoms associated with lactose intolerance, especially for those
patients with moderate to severe symptoms [Objective Insights, “Market Research Analysis and Forecasts on Lactose Intolerance
and RP-G28” (June 2012)]. Patients with moderate to severe symptoms have a challenging time completely avoiding dairy
foods all together. Physicians experience a steady stream of lactose intolerance cases. It is estimated that gastroenterologists
see approximately 15 new patients with lactose intolerance each month [Objective Insights, “Market Research Analysis
and Forecasts on Lactose Intolerance and RP-G28” (June 2012)].
Doctors
tend to diagnose lactose intolerance in a patient before the patient is able to self-diagnose it [Objective Insights, “Market
Research Analysis and Forecasts on Lactose Intolerance and RP-G28” (June 2012)]. However, patients tend to initiate
discussion about lactose intolerance with their doctors. This is indicative of broad public awareness of lactose intolerance.
Doctors often administer two tests for diagnosing lactose intolerance: (i) a symptom history test and (ii) a hydrogen breath test.
Approximately 50% of people diagnosed with lactose intolerance undergo a symptom history test [Objective Insights, “Market
Research Analysis and Forecasts on Lactose Intolerance and RP-G28” (June 2012)]. A symptom history test is the foundation
for diagnosis of lactose intolerance reported by all physicians interviewed [Objective Insights, “Market Research Analysis
and Forecasts on Lactose Intolerance and RP-G28” (June 2012)].
Our
Competitive Strengths
Market
Opportunity
RP-G28
has the potential to become the first approved drug in the United States and Europe for the reduction of symptoms associated with
lactose intolerance.
Renowned
Scientific Team and Management Team
Our
leadership team has extensive biotechnology/pharmaceutical expertise in discovering, developing, licensing and commercializing
therapeutic products. We have attracted a scientific team comprised of innovative researchers who are renowned in their knowledge
and understanding of the host-microbiome in the field of lactose intolerance and gastroenterology.
Substantial
Patent Portfolio and Product Exclusivity
We
have an issued patent in the United Kingdom directed to the composition of non-digestible carbohydrates, and we have issued patents
in the United States directed to methods of using such compositions for the treatment of lactose intolerance and symptoms. Additional
worldwide patent applications are pending. The patent applications include claims covering compositions, methods, formulations
and packaging.
In
addition, in July 2015 we acquired the rights, title and interest to certain patents and related patent applications with
claims covering a process for producing ultra high purity galacto-oligosaccharide active pharmaceutical ingredients,
including RP-G28 from our supplier. See “Business—Clinical Supply and Cooperation Agreement with Ricerche
Sperimentali Montale and Inalco SpA” for additional details regarding the second amendment to the exclusive supply
agreement and our exercise of the exclusive option.
See
“Business—Intellectual Property” for additional information regarding our patent portfolio.
Our
Growth Strategy
In
order to achieve our objective of developing safe and effective applications to treat conditions associated with microbiome disfunctions,
our near-term and long-term strategies include the following:
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Complete
an adaptive design Phase 2b/3 clinical trial and any additional pivotal studies of RP-G28 for the reduction of symptoms associated
with lactose intolerance; |
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seek
regulatory approval of RP-G28 for the reduction of symptoms associated with lactose intolerance if the clinical trials are
successful, initially in the United States and subsequently in the rest of the world; |
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develop
and commercialize RP-G28 either by ourselves or in collaboration with others throughout the world; |
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explore
the use of RP-G28 for additional potential therapeutic indications and orphan indications; |
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establish
the Company as a leader in developing therapeutics that modulates the human gut microbiome; |
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continue
to develop a robust and defensible patent portfolio, including those we own and those we plan to in-license in the future;
and |
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continue
to optimize our product development and manufacturing capabilities both internally and externally through outside manufacturers.
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Clinical
and Regulatory
IND
Application/Phase 1
The
IND application for RP-G28 was submitted to the FDA in June 2010. The safety and tolerability profile, pharmacokinetics and dose
response curve of GOS products are well understood. Therefore, as part of the IND submission, we proposed that the data supporting
the IND was sufficient to support a Phase 2 proof-of-concept study in a small number of lactose-intolerant patients. The FDA agreed
with this proposal and the typical Phase 1 clinical program in healthy volunteers was replaced by a Phase 2a program in subjects
with lactose intolerance.
On
June 28, 2010, we received an advice letter from the FDA regarding our IND submission. The FDA suggested that we (1) consider
expanding our inclusion criteria to include females of childbearing potential who are willing to use appropriate contraception
throughout the duration of the protocol; (2) follow the FDA’s guidance regarding Patient-Reported Outcome Measures; and
(3) include a pharmacokinetic study in our proposed Phase 2a trial to determine the extent of systemic exposure of RP-G28.
Phase
2a Study
On
June 12, 2013, we announced positive data from our Phase 2a first-in-human, proof of concept clinical study of RP-G28. The purpose
of the study was to assess the effectiveness, safety and tolerability of RP-G28 compared to a placebo when administered to subjects
with symptoms associated with lactose intolerance. The results were presented at Digestive Diseases Week and the New York Academy
of Sciences Conference on Probiotics, Prebiotics and the Host Microbiome: The Science of Translation, and co-sponsored by the
Sackler Institute for Nutrition Science and the International Scientific Association of Probiotics and Prebiotics.
The
double-blinded, randomized, multi-center, placebo-controlled Phase 2a study evaluated RP-G28 in 62 patients with lactose intolerance
over a treatment period of 35 consecutive days. Post-treatment, subjects reintroduced dairy into their diets and were followed
for an additional 30 days to evaluate lactose digestion, as measured by hydrogen production and symptom improvements. In order
to confirm lactose intolerance and study participation, subjects underwent a 25-gram lactose challenge in the clinic. Lactose
intolerance symptoms and hydrogen production via hydrogen breath test were assessed for six hours post-lactose dose. Eligible
subjects were required to demonstrate a minimum symptom score and a “positive” hydrogen breath test in order to be
eligible for randomization. A “positive” breath test was defined as a hydrogen gas elevation of 20 parts per million
(ppm) at two time-points within the six hours following a lactose-loading dose. The primary endpoints included tracking patients’
gastrointestinal symptoms via a patient-reported symptom assessment instrument (a Likert Scale, measuring individual symptoms
of flatulence, bloating, cramping, abdominal pain and diarrhea, on a scale of 0 (none) to 10 (worst)) at baseline, day 36 and
day 66; as well as the measurement of hydrogen gas levels in their breath following a 25-gram lactose challenge.
RP-G28
was well tolerated, with no significant adverse events reported. The Phase 2a study demonstrated clinically meaningful benefits
to patients on treatment, whereas treated subjects reported increased tolerance to lactose and dairy foods: reduced lactose intolerance
symptoms (gas, bloating, cramping and abdominal pain) were reported in subjects on RP-G28, a durable reduction in abdominal pain
(p=0.019) was reported, and treated patients were six times more likely to describe themselves as lactose tolerant (p=0.039).
In sum, positive trends were seen when the entire per protocol study population was analyzed, including some statistically significant
subgroup analysis, suggesting that a therapeutically positive effect is seen. Although there were few primary and secondary efficacy
endpoints with statistically significant results, the combined data suggest that RP-G28 is exerting a positive therapeutic effect.
We believe these positive drug effect trends combined with the benign safety profile support continued drug development of RP-G28.
Key
findings of the Phase 2a study include:
|
● |
RP-G28
was well tolerated with no significant study-drug related adverse effects. The benign adverse event safety profile of RP-G28
with dose levels up to 15 gm/day observed in this study is consistent with the known safety of GOS products administered up
to 20 gm/day reported in literature. |
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Subjects
in the RP-G28 group reported a reduction in total symptoms after treatment. Reported symptom improvement continued 30 days
post-treatment. Improvement in symptoms was assessed in the study using several different measures, including a pain Likert
scale and a patient global assessment. Subjects receiving RP-G28 had greater improvement in most of their symptoms (cramps,
bloating and gas) following lactose challenge compared to placebo, but the differences were not statistically significant
given the small cohort size. However, a clinically meaningful reduction in abdominal pain was seen in subjects receiving RP-G28
compared to placebo. |
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An
analysis of “responders” for abdominal pain (defined as subjects who reported a score of zero in abdominal
pain severity following a lactose challenge at Day 36/Hour 6 and Day 66/Hour 6) was performed. In the 55 subjects who noted
abdominal pain following the baseline (Day 0) lactose challenge, 50% of RP-G28-treated subjects reported no abdominal pain
compared to 17% of the placebo-treated subjects. This difference was statistically significant (p = 0.0190). See Figure 3
below. |
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Further,
an analysis of “responders” for abdominal pain (defined as subjects who reported a greater than 50% decrease
in abdominal pain severity following lactose challenge between Day 0/Hour 6 and Day 36/Hour 6) was performed. In the 55 subjects
who noted abdominal pain following the baseline (Day 0) lactose challenge, 72.2% of RP-G28-treated subjects reported a >50%
reduction in abdominal pain severity compared to 42.1% of the placebo-treated subjects. This difference was also statistically
significant (p=0.0288). |
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To
better explore a meaningful benefit to patients, a global assessment was explored. Six times as many patients in the treatment
group versus the placebo group described themselves as lactose tolerant and did not report symptoms associated with lactose
intolerance on Day 66. After completion of study treatment at Day 36, subjects were encouraged to re-introduce dairy foods
into their diet. Thirty days later (Day 66), subjects were asked to provide an assessment of their symptom status, i.e., whether
they considered themselves still lactose intolerant compared with subjects receiving placebo (Yes/No). As seen below in Figure
3 below, in the 58 subjects providing responses, a significantly larger percentage of subjects receiving RP-G28 (30%) considered
themselves no longer lactose intolerant compared with subjects receiving placebo (5.6%); this result was statistically significant
(p=0.0389). |
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The
reduction in total symptoms following a post-treatment lactose challenge was consistent with the improvement in post-treatment
hydrogen breath test results as compared to baseline (pre-treatment) results. Although rarely used in clinical practice and
primarily used to identify lactase deficiency, hydrogen measurements were used as an eligibility criterion as well as an outcome
measure in our Phase 2a proof-of-concept study. Our intent was to better understand how lactose intolerant symptoms and hydrogen
values correlated and whether a treatment effect could be detected by hydrogen production. In the RP-G28 group, the median
peak hydrogen production was 113 ppm on Day 0 and 110 ppm on Day 36. In the placebo group, the median peak hydrogen production
was 94 ppm at Day 0 and 113 on day 36. At Day 0 and Day 36, the median total hydrogen production was 385 ppm and 367 ppm,
respectively, for the RP-G28 group and 347 and 436 ppm, respectively, for the placebo group. Comparison of the hydrogen breath
test results between RP-G28 and placebo shows that median hydrogen production was generally similar between the two treatment
groups at Day 0 while at Day 36, median hydrogen production was lower in the RP-G28 group compared to placebo at the peak
time points of 2 to 4 hours. While the differences were not large, the RP-G28 group had consistently lower levels of breath
hydrogen production from Hours 2 to 6 following lactose challenge, but the results did not correlate with clinical symptoms.
In the Placebo group, differences in hydrogen production following lactose challenge were not apparent. |
Figure
1
In
the Phase 2a study, changes in the fecal microbiome were investigated using both Terminal Restriction Fragment Length Polymorphisms
(TRFLP), a molecular biology technique for profiling microbial communities based on the position of a restriction site closest
to a labeled end of an amplified gene, and microme analysis of 16S rRNA genex by pyrosequencing, a method of DNA sequencing (determining
the order of nucleotides in DNA).
Figure
2
In
addition, Principal Component Analysis (PCA), a multivariate method that helps transform a number of possibly correlated variables
into a smaller number of uncorrelated variables called principal components, thereby reducing the dimensions of a complex dataset,
showed statistically significant shifts in the microbiome of subjects fed RP-G28, compared to placebo, at 66 days. Specifically,
RP-G28 significantly altered the microbiomes of 82% of the study participants who received the treatment.
Pre-treatment,
three distinct clusters were identified, whereas post-treatment (Day 66) two distinct clusters were identified, showing a clear
shift in certain species represented before and after treatment.
Principal
Coordinates Analysis (PCoA), a multivariate method that helps visualize similarities and dissimilarities in large datasets, was
also utilized to analyze the microbiome data. For analysis of 16S amplicon sequencing data, we created Unweighted Unifrac similarity
matrices (that is we conducted PCoA) and applied ANOSIM (Analysis of Similarities) and PERMANOVA (Permutational Analysis of Variance)
statistical analyses. Our analysis showed a significant association between Day (day 0 or baseline, and day 36 and 66 as categories)
and microbiome composition (ANOSIM R = 0.218, P = 0.0001, PERMANOVA Pseudo-F = 3.4318, P = 0.0001). These data indicate that RP-G28
and subsequent introduction of lactose into the diet had impacted the fecal microbiome of participants. Further, lactose metabolizing
bacteria were shown to increase in the treatment group.
The
results of our Phase 2a study were published in Nutrition Journal in a manuscript entitled “Improving lactose digestion
and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial.”
We
held a Type C meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products on February 20, 2013. The purpose
of the meeting was to obtain the FDA’s feedback on the planned Phase 2 program and Phase 3 programs, inform the FDA of our
ongoing development plans, gain feedback on relevant clinical trial design and end points related to patient meaningful benefits,
and to inform the FDA of the status of our product characterization. We believe that this meeting was a significant step forward
in streamlining the pathway to initial U.S. approval of RP-G28 to reduce symptoms and frequency of symptomatic episodes associated
with lactose intolerance. The meeting and official meeting minutes provided valuable guidance on the development path of RP-G28:
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The
FDA agreed with our decision to develop and validate a new analytical assay for RP-G28 drug substance and drug product. This
adjustment will provide additional information about GOS components and non-GOS impurities, which the FDA agrees should be
in place before we prepare batches of the drug substance for use in any pivotal Phase 3 clinical trials. |
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Based
on our plan to conduct ICH-compliant GLP embryo-fetal development toxicology studies (in two species) and the ICH standard
battery of genotoxicity tests using RP-G28, the FDA agreed that no additional nonclinical studies are needed at this time
to support Phase 3 studies. |
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The
FDA advised us on potential end points and clinical trial design. |
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We
addressed the FDA’s recommendation in its June 28, 2010 advice letter that we include a pharmacokinetic study in the
Phase 2b study to assess the extent of systemic exposure of RP-G28. We explained to the FDA that we did not collect serum
samples for pharmacokinetic measurement in the Phase 2a study because at the time assays for measuring RP-G28 were not available
and significant systemic absorption was not anticipated. We then informed the FDA of our plan to evaluate alternatives, as
a surrogate for RP-G28 systemic exposure as part of our Phase 2b program. The FDA agreed with this approach. |
Following
analysis of the Phase 2a clinical trial, discussions with the FDA in 2013 about our clinical development plan, and further discussions
with our regulatory consultants, we intend to conduct our planned Phase 2b clinical trial as an adaptive design Phase 2b/3 clinical
trial. We believe this trial could serve as one of two pivotal trials should the resulting data and the FDA be supportive of this
trial as a pivotal trial. We do not intend to discuss the Phase 2b/3 study design and development plan with the FDA, though we
are required to and will submit a supplement to the IND detailing the protocols for the adaptive study.
We
plan to commence this clinical program in the first quarter of 2016. The Phase 2b/3 study will be designed to evaluate dosing,
safety and efficacy of RP-G28 to decrease abdominal pain and other symptoms related to lactose intolerance. The plans for the
Phase 2b/3 study are to (1) evaluate the efficacy of multiple dose levels of RP-G28, and (2) collect qualitative and quantitative
evidence to finalize development of its end points to be studied during the later Phase 3 pivotal trial.
Nonclinical
Safety Plans
Given
the established safety profile of GOS in humans and the lack of significant safety concerns with RP-G28 administered to subjects
in the Phase 2a study, no additional non-clinical safety studies are planned to support continued evaluation of RP-G28 in the
Phase 2 program.
Guidelines
adopted by the FDA and established by ICH require nonclinical studies that specifically address female fertility to be completed
before the inclusion of women of child bearing potential in large-scale or long-duration clinical trials (e.g., Phase 3 trials).
In the United States, such assessments of embryo-fetal development can be deferred until before Phase 3 using precautions to prevent
pregnancy in clinical trials. As the FDA recommended in their June 28, 2010 advice letter, we will continue to evaluate females
of child-bearing potential who are willing to use appropriate contraception throughout the duration of any study. In addition,
to support Phase 3 studies, we plan to perform ICH-compliant embryo-fetal development toxicology studies of RP-G28. We will then
confirm any negative findings from these toxicology studies in a standard battery of ICH-compliant genotoxicity tests using RP-G28.
As
FDA recommended in their June 28, 2010 advice letter, we will continue to evaluate females of child-bearing potential who are
willing to use appropriate contraception throughout the duration of the protocol. To support Phase 3 studies, we plan to perform
ICH-compliant GLP embryo-fetal development toxicology studies of RP-G28. Ritter also plans to confirm the negative findings in
a standard battery of ICH-compliant, GLP genotoxicity tests using RP-G28.
Planned
Phase 2b/3 Study
The
Phase 2b/3 clinical trial that we intend to conduct is being designed as a multi-center double-blinded, placebo controlled clinical
trial of approximately 300 subjects to determine the maximum tolerated dose and optimal dose-escalation schedule for RP-G28. The
trial is going to assess patients with moderate to severe abdominal pain as measured by a pain Likert scale after a lactose challenge.
The Phase 2b/3 clinical trial is being designed to measure additional lactose intolerance symptoms (gas, bloating, diarrhea, cramps)
as secondary endpoints. Entry criteria in the Phase 2b/3 study will include a hydrogen breath test to validate lactase deficiency.
The Phase 2b/3 study design includes a screening phase; a 30-day course treatment phase and a 30-day post-treatment evaluation
phase. The study is designed to gradually escalate the dose beyond the 15 gm/day dose level evaluated in the Phase 2a study. Study
subjects are going to abstain from lactose containing food products and then be randomized evenly (1:1:1:1) to receive one of
three doses of RP-G28 or placebo for 30 days. Subjects are then going to be followed post-treatment for an additional 30 days
while lactose containing food products are re-introduced into their diets. The primary endpoint for the Phase 2b/3 clinical study
will be a durable reduction in abdominal pain, with secondary endpoints measuring changes in individual lactose intolerance symptoms
(gas, bloating, diarrhea, cramps). The Phase 2b/3 study is also designed to include collection of blood samples to assess systemic
exposure to RP-G28 using measurement of serum concentrations of a trisaccharide. This is going to be monitored as a surrogate
to assess the systemic bioavailability of orally administered RP-G28. Additionally, the study will require the collection of fecal
samples from patients enrolled to evaluate the baseline and changes to the patient’s microbiome that correlate to symptom
reduction and lactose tolerance.
In
order to gather long-term data on subjects exposed to RP-G28, we also intend for subjects completing the Phase 2b/3 protocol to
be offered enrollment in an observational extension study, G28-004. As RP-G28 is expected to provide extended relief from lactose
intolerance symptoms beyond the initial 30-day treatment phase, this extension study for the Phase 2b/3 program is going to assess
the long-term treatment effect. We intend for the results from this study to guide the need to evaluate an additional 30-day course
of treatment in Phase 3 in subjects who experience the return of lactose intolerance symptoms after an initial course of RP-G28.
Adaptive
seamless phase 2b/3 designs, such as the Phase 2b/3 pivotal clinical trial for RP-G28 that we are contemplating, are aimed at
interweaving the two phases of full development by combining them into one single, uninterrupted study conducted in two steps.
Adaptive seamless phase 2b/3 designs enable a clinical trial to be conducted in steps with the sample size calculation selected
on the basis of data observed in the first step to continue along to the second step. The main statistical challenge in such a
design is ensuring control of the type I error rate. Most methodology for such trials is based on the same endpoint being used
for interim and final analyses. A type I error is one in which the adaptation process leads to design, analysis, or conduct flaws
that introduce bias that increases the chance of a false conclusion that a treatment is effective (a type I error). Controlling
type I error can be accomplished by prospectively specifying and including in the statistical analysis plan all possible adaptation
plans that may be considered during the course of the trial. We intend to work with a CRO to determine how best to control type
I error in our Phase 2b/3 study.
Research
and Development Agreement with Kolu Pohaku Technologies and Kolu Pohaku Management, LLC
As
described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” on November
30, 2010, we entered into the R&D Agreement with KPT and KPM. The R&D Agreement called for KPT to make a series of payments
to us totaling $1,750,000 in exchange for us performing certain research and development activities in Hawaii for the benefit
of KPT (referred to herein as the KP Research), from the effective date of the agreement through December 31, 2014. The KP Research
consisted of the initial phase of research, including the conduct of Phase 2 clinical trials in Hawaii for RP-G28. Under the terms
of the R&D Agreement, we maintained sole and exclusive control over the manner in which we and our employees and contractors
performed the KP Research and ownership of the results of our ongoing research related to RP-G28, although KPT maintained ownership
of the results of the KP Research. Inventions, developments, and improvements arising out of the KP Research were owned by KPT.
Under the terms of the R&D Agreement we would bear any costs involved in obtaining patents for any inventions, developments
or improvements resulting from the KP Research. In exchange for the irrevocable, perpetual, exclusive, worldwide right and license
to the results of the KP Research, we agreed to pay a quarterly royalty payment to KPT of $32,000 commencing March 31,
2015 and continuing through December 31, 2035 or until such time as the KPM Option (describe below) was exercised. The license
included, without limitation, our right to sublicense the KP Research and to make, have made, use, sell, offer for sale and import
products based, in whole or in part, on the KP Research. The R&D Agreement was subsequently amended on, July 6, 2011, September
30, 2011, February 6, 2012 and November 4, 2013 to increase the funding to be received by us thereunder and to add royalty payments
made by us for years subsequent to the original agreement.
In
connection with the R&D Agreement, we also granted an option, the KPM Option, to KMP. Pursuant to the terms of the KPM Option
Agreement, we had the right to put to KPM and KPM had the right to call from us 1,469,994 shares of our Series B preferred stock
at any time after December 31, 2014. The number of shares was determined by dividing the $1,750,000 of payments made by KPT to
us under the R&D Agreement by the Series B preferred stock original issue price of $1.19 per share. On March 26, 2015,
we exercised our right to put the KPM Option and issued 1,469,994 shares of Series B preferred stock to KPM, or the KPM Shares.
Pursuant to the terms of the KPM Option Agreement, our issuance of the KPM Shares to KPM resulted in the full satisfaction of
our obligation to make royalty payments to KPT under the R&D Agreement and also resulted in the termination of the R&D
Agreement and therefore KPM’s and KPT’s right, title, and interest in the KP Research under the R&D Agreement
is assigned to Ritter. KPM and KPT have agreed to take all steps necessary to perfect the assignment of such right, title, and
interest to Ritter.
Clinical
Supply and Cooperation Agreement with Ricerche Sperimentali Montale and Inalco SpA
In
December 2009, we entered into a Clinical Supply and Cooperation Agreement, or the Supply Agreement, with Ricerche Sperimentali
Montale, or RSM, and Inalco SpA, or Inalco. Pursuant to the terms of the Supply Agreement, RSM has exclusively manufactured for
us, and will continue to manufacture for us in connection with our Phase 2b/3 study, an improved form of GOS (higher purity),
or Improved GOS. RSM also agreed that it will not, except as necessary for RSM to perform its obligations under the Supply Agreement,
market or sell Improved GOS, or any galacto-oligosaccharides that are of greater purity to any third party. In addition to our
payments to RSM for the GOS manufactured or to be manufactured by RSM for us in connection with our clinical trials, we agreed
to pay RSM certain milestone payments including a payment of $50,000 as consideration for its assistance in seeking the
necessary regulatory approvals for RP-G28 (consisting of a payment of $25,000 upon the effective date of the Supply Agreement
and a payment of $25,000 upon completion to our satisfaction of the drug master file submission to the FDA related to
RP-G28 or another product using Improved GOS). We also agreed to pay a monthly fee of $7,000 in consideration of the services
provided by RSM under the agreement, which will become payable 30 days after our receipt of $10,000,000 from a financing
transaction, or the Financing Receipt, until such time as the parties agree that RSM’s support for regulatory approval is
no longer required, which is expected to be after the completion of our Phase 3 studies. Pursuant to the terms of the Supply Agreement,
we also agreed to reimburse RSM for its reasonable costs actually incurred in purchasing certain equipment required to perform
its analysis methods for Improved GOS, which equipment we will own upon payment.
Pursuant
to the terms of the Supply Agreement, RSM granted us an exclusive worldwide option to the assignment of all right, title and interest
to the Improved GOS, or the Improved GOS IP, which we could exercise by paying RSM $1,000,000, within 10 days of a Financing Receipt,
which would include our initial public offering. As additional consideration for the assignment of the Improved GOS IP, we agreed
to pay RSM an additional $1,000,000 within 10 days of the approval by the FDA of the NDA for our first product containing Improved
GOS. Under the terms of the Supply Agreement, we would continue to make the monthly payments to RSM until such time as the parties
agree that RSM’s support for regulatory approval is no longer required. See the section below entitled “Intellectual
Property — Patents and Proprietary Rights Covering Our Drug Candidates” for additional information regarding
the Improved GOS IP.
Pursuant
to the terms of the Supply Agreement, the parties to the Supply Agreement agreed that in the event we are able to obtain a Financing
Receipt, the parties will enter into a further agreement, or the Proposed Agreement, for the purpose of clarifying future manufacturing
services to be provided by RSM to us regarding Improved GOS and payment by us for such services. The Supply Agreement sets forth
certain terms and conditions that the parties to the agreement have agreed will be included in the Proposed Agreement, including,
among other things, a provision that calls for certain milestone payments to be paid to RSM by us in the event we receive approval
from the FDA to market RP-G28 or another product using Improved GOS, which milestone payments will be based upon the number of
“units” sold by us containing Improved GOS. The Proposed Agreement will terminate upon the expiration of the first
patent filed by RSM regarding Improved GOS.
The
Supply Agreement was amended in September 2010. Pursuant to the terms of this amendment, we have paid all obligations to RSM in
satisfaction of the payment due to RSM upon completion to our satisfaction of the drug master file submission to the FDA related
to RP-G28 (as described above). The amendment also further defined the terms and conditions of the supply of Improved GOS by RSM
to us to ensure adequate and timely delivery of Improved GOS to us.
The
Supply Agreement was further amended on July 24, 2015. Pursuant to the terms of the second amendment to the Supply Agreement,
the provisions related to the exclusive worldwide option to the assignment of all right, title and interest to the Improved GOS
IP were amended to provide that we could exercise the option by paying RSM $800,000 within ten days after the effective date of
Amendment No. 2. We exercised the option on July 30, 2015 and RSM transferred the Improved GOS IP to us. Under the terms of the
Supply Agreement, as amended, if we fail to make any future option payment required under the terms of the Supply Agreement, we
may be required to return the Improved GOS IP to RSM. The terms of the second amendment to the Supply Agreement require us to
pay RSM $400,000 within 10 days following FDA approval of a new drug application for the first product owned or controlled by
us using Improved GOS as its active pharmaceutical ingredient and to pay RSM the sum of $250 per kilo for clinical supply of Improved
GOS instead of $2,000 per kilo as was previously required.
In
consideration for RSM entering into the second amendment to the Supply Agreement, we issued 100,000 shares of our common stock
to RSM pursuant to a stock purchase agreement. The shares issued to RSM are subject to a lock-up agreement, pursuant to which
RSM has agreed that it will not sell these shares for a period ending on the earlier of (i) the public release by us of the final
results of our Phase IIb/III clinical trial of RP-G28 and (ii) the filing of a Form 10-Q with the SEC for the fiscal quarter in
which we receive the results of our Phase IIb/III clinical trial of RP-G28.
Master
Service Agreement
On
December 30, 2015, we entered into a Master Service Agreement with Covance, with an effective date of December 29, 2015. Pursuant
to the terms of the Master Service Agreement, Covance (or one or more of its affiliates) will provide Phase I/II/II/IV clinical
services for a clinical study or studies to us, and, at our request, assist us with the design of such studies, in accordance
with the terms of separate individual project agreements to be entered into by the parties. The term of the agreement is for three
years and will renew automatically for successive one year periods unless Covance is no longer providing services under the agreement
or either party has terminated the agreement upon written notice. We may terminate the Master Service Agreement or any individual
project agreement entered into under the Master Service Agreement prior to the applicable study’s completion at any time
for any reason upon 30 days written notice to Covance, except when the reason for termination is the safety of subjects, in which
case it may be terminated immediately. Covance may not terminate any individual project agreement without cause, except when the
reason for the termination is the safety of subjects, in which case it may be terminated immediately. In the event of a termination
of the Master Service Agreement, Covance will be entitled to full payment for (i) work performed on the applicable project upon
through the date work on such project is concluded and (ii) reimbursement for all non-cancellable and non-refundable expenses
and financial obligations which Covance (or an affiliate) has incurred or undertaken on our behalf.
Commercialization
Given
our stage of development, we have not yet established a commercial organization or distribution capabilities. RP-G28, if approved,
is intended to be prescribed to patients suffering from lactose intolerance. These patients are normally under the care of a gastroenterologist
and/or a primary care physician. Our current plan is to evaluate a possible partnership to commercialize RP-G28 for the reduction
of symptoms associated with lactose intolerance in patients in the United States and Europe if it is approved. We may also build
our own commercial infrastructure or utilize contract reimbursement specialists, sales people and medical education specialists,
and take other steps to establish the necessary commercial infrastructure at such time as we believe that RP-G28 is approaching
marketing approval. Outside of the United States and Europe, subject to obtaining necessary marketing approvals, we will likely
seek to commercialize RP-G28 through distribution or other collaboration arrangements for patients suffering from lactose intolerance.
Competition
The
biopharmaceutical industry is characterized by intense competition and rapid innovation. Although we know of no other drug candidate
in advanced clinical trials for treating lactose intolerance, other biopharmaceutical companies may be able to develop other compounds
or drugs that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceutical
companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements
with large, established companies. We believe the key competitive factors that will affect the development and commercial success
of our product candidates are efficacy, safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.
Intellectual
Property
The
proprietary nature of, and protection for, our product candidates and our discovery programs, processes and know-how are important
to our business. We have sought patent protection in the United States and internationally for uses of RP-G28 and our discovery
programs, and any other inventions to which we have rights, where available and when appropriate. Our policy is to pursue, maintain
and defend patent rights, whether developed internally or licensed from third parties, and to protect the technology, inventions
and improvements that are commercially important to the development of our business. We also rely on trade secrets that may be
important to the development of our business. We do not have composition of matter patent protection for RP-G28, which may result
in competitors being able to offer and sell products so long as these competitors do not infringe any other patents that we hold,
or that third parties hold, including patents in Europe to which we have an exclusive option of assignment, which are directed
to methods of manufacturing and purified RP-G28, and U.S. patents that we own, that are directed to methods of using RP-G28.
Our
commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current
and future product candidates and the methods used to develop and manufacture them, as well as successfully defending these patents
against third-party challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our
products depends on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.
We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent
applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted
to us in the future will be commercially useful in protecting our product candidates, discovery programs and processes from commercial
competition. Furthermore, we cannot be sure that issued patents will not be challenged in court as invalid or in the Patent Office
as unpatentable. For this and more comprehensive risks related to our intellectual property, please see “Risk Factors — Risks
Relating to Our Intellectual Property.”
Patents
and Proprietary Rights Covering Our Drug Candidates
We
strive to protect our product candidates and exclusivity rights, as well as both maintain and fortify our position in the field
of reduction of symptoms associated with lactose intolerance. We believe our intellectual property portfolio consists of early
and broad filings in the area. We have focused on patents and patent applications relating to where possible, use of our products
in disease treatment. We have sought and continue to seek the strongest possible intellectual property protection available to
us in order to prevent others from directly competing with us, as well as to exclude competition around our products where possible,
their manufacture, and methods for use of the products in disease treatment. Our intellectual property portfolio related to RP-G28
contains four issued patents and at least 15 other related, pending patent applications in the United States and worldwide for
Ritter Pharmaceuticals-owned inventions. As described above, Ritter Pharmaceuticals also holds an option to acquire a patent family,
currently owned and controlled by Inalco, S.p.A., including claims generally directed to processes for producing an improved form
of galactoologosaccharides (GOS) mixtures (higher purity); this family includes issued patents in Italy (not expiring until 2029),
Germany, and the Netherlands (not expiring until 2030), as well as applications pending in the United States, China, India, and
other jurisdictions that, if issued, will not expire until 2030.
This
portfolio includes patents and proprietary rights related to:
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U.S.
Patent No. 8,486,668, which has a current expiry date of February 17, 2030, includes claims generally directed to methods
for treating lactose intolerance comprising administering, for a predetermined number of days, a high purity galactooligosaccharides
(GOS) pharmaceutical composition, and wherein the administration leads to a persistent decrease in at least one symptom of
lactose intolerance; |
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U.S.
Patent No. 8,492,124, which has a current expiry date of February 17, 2030, includes claims generally directed to methods
for treating lactose intolerance comprising administering, for a predetermined number of days, a controlled release pharmaceutical
composition that contains galoctooligosaccharides (GOS), but does not contain a probiotic; |
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U.S.
Patent No. 8,785,160, which has a current expiry date of February 17, 2030, includes claims generally directed to methods
for treating lactose intolerance comprising administering a hydrogen breath test, diagnosing lactose intolerance based upon
the hydrogen breath test, and administering a high purity galactooligosaccharides (GOS) pharmaceutical composition; and |
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United
Kingdom Patent No. GB2480042, which has a current expiry date of February 16, 2030, includes claims generally directed to
a solid oral unit-dosage form of a high purity galactoologosaccharides (GOS). |
The
Company is pursuing patent applications. These applications are pending in the United States, Europe, Japan and other jurisdictions,
and, if they issue as patents, will not expire until at least 2030, and include claims generally directed to (i) oral dosage forms
of a higher purity galactoologosaccharides (GOS), (ii) use of galactoologosaccharides (GOS) for treating lactose intolerance,
and (iii) methods of preventing or reducing certain symptoms of lactose intolerance using galactoologosaccharides (GOS) dosage
forms.
Intellectual
Property Strategy
We
continually assess our intellectual property strategy in order to fortify our position in our market space. To that end, we are
prepared to file additional patent applications in any of the above families should our intellectual property strategy require
such filings and/or where we seek to adapt to competition or seize business opportunities. Further, we are prepared to file patent
applications relating to the other products in our pipeline soon after the experimental data necessary for a strong application
become available and our cost-benefit analyses justify filing such applications. In addition to filing and prosecuting patent
applications in the United States, we typically file counterpart patent applications in Europe and additional countries where
we think such foreign filing is likely to be beneficial.
We
do not know if patents will be issued for all of the patent applications in our portfolio. Furthermore, for patent claims now
issued and for claims to be issued in the future, we do not know if such claims will provide significant proprietary protection
to our drug candidates and proprietary technologies or if they will be challenged, circumvented, or invalidated. Our success will
in part depend on our ability to obtain and maintain patents protecting our drug candidates, technologies and inventions, to operate
without infringing the proprietary rights of third parties, and to enforce and defend our patents and ensure others do not infringe
on our proprietary rights.
The
term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries
in which we file, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United
States, a patent’s term may be shortened if a patent is terminally disclaimed over another patent or as a result of delays
in patent prosecution by the patentee, and a patent’s term may be lengthened by patent term adjustment, which compensates
a patentee for administrative delays by the U.S. Patent and Trademark Office in granting a patent.
The
patent term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent
term restoration as compensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition
and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, permits a patent term extension of up to five years
beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug or biologic
is under regulatory review. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the
date of product approval and only one patent applicable to an approved drug or biologic may be extended. Similar provisions are
available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug or biologic. In
the future, if and when our pharmaceutical products receive FDA approval we expect to apply for patent term extensions on patents
covering those products. We anticipate that some of our issued patents may be eligible for patent term extensions. For more information
regarding U.S. patent laws, see “Business — Government Regulation.”
In
addition to the patent term extension rights described above, any of our product candidates that receive FDA approval may also
be eligible for market exclusivity protection under the Federal Food, Drug and Cosmetic Act or the Biologics Price Competition
and Innovation Act of 2009. For more information regarding market exclusivity laws, see “Business — United
States Government Regulation.”
Many
pharmaceutical companies, biotechnology companies and academic institutions are competing with us in the field of the reduction
of symptoms associated with lactose intolerance and the manufacture of purified galactooligosaccharides, generally, and are filing
and prosecuting patent applications potentially relevant to our business. In order to contend with the inevitable possibility
of third party intellectual property conflicts, from time to time, we review and assess the third-party intellectual property
landscape for competitive and other developments that may inform or impact our intellectual property development and commercialization
strategies. From time to time, we may find it necessary or prudent to obtain licenses from third party intellectual property holders.
Where licenses are readily available at reasonable cost, such licenses are considered a normal cost of doing business. In other
instances, however, where a third party holds relevant intellectual property and is a direct competitor, a license might not be
available on commercially reasonable terms or available at all. Accordingly, we attempt to manage the risk that such third party
intellectual property may pose by conducting, among other measures, patent landscape studies to guide our early-stage research
away from areas where we are likely to encounter obstacles in the form of third party intellectual property. As our programs advance,
we continue to monitor the intellectual property landscape in an effort to assess the advisability of licensing third party intellectual
property or taking other appropriate steps to address such development issues in the manner we deem in the best interests of the
Company.
With
respect to third party intellectual property, it is impossible to establish with certainty that our product candidates will be
free of claims by third party intellectual property holders or whether we will require licenses from such third parties. Even
with modern databases and on-line search engines, literature searches are imperfect and may fail to identify relevant patents
and published applications. Further, pending patent applications may not be published or otherwise accessible through literature
searches. Even when a third party patent is identified, we may conclude upon a thorough analysis that we do not infringe the patent
or that the patent is invalid. If the third party patent owner disagrees with our conclusion and we continue with the business
activity in question, we might have patent litigation thrust upon us. Alternatively, we might decide to initiate litigation (or
an administrative proceeding in the Patent Office) in an attempt to have a court declare the third party patent invalid or we
may decide to initiate litigation in an attempt to have a court declare the third party patent not infringed by our existing or
planned activity. In either scenario, patent litigation or post-grant challenges in the Patent Office typically are costly and
time-consuming, and the outcomes are uncertain. The outcome of patent litigation and/or post-grant challenges in the Patent Office
are subject to uncertainties that cannot be quantified in advance, for example, the credibility of expert witnesses who may disagree
on technical interpretation of scientific data. Ultimately, in the case of an adverse outcome in litigation, we could be prevented
from commercializing a product or using certain aspects of our discovery platform as a result of patent infringement claims asserted
against us. This could have a material adverse effect on our business.
To
protect our competitive position, it may be necessary to enforce our patent rights through litigation against infringing third
parties. Litigation to enforce our own patent rights is subject to the same uncertainties discussed above. In addition, however,
litigation involving our patents carries the risk that one or more of our patents will be held invalid (in whole or in part, on
a claim-by-claim basis), being held unenforceable, or being subject to a post-grant challenge in the Patent Office and deemed
unpatentable. Such adverse court rulings could allow third parties to commercialize virtual copies our products, and then compete
directly with us, without payment to us.
Trade
Secrets
In
addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. Trade secrets and
know-how can be difficult to protect. We seek to protect our proprietary processes, in part, by confidentiality agreements and
invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners. These
agreements are designed to protect our proprietary information. We also seek to preserve the integrity and confidentiality of
our data, trade secrets and know-how by maintaining physical security of our premises and physical and electronic security of
our information technology systems.
Option
to Acquire Inalco Patent
We
are party to a Clinical Supply and Cooperation Agreement with Richerche Sperimental Montale spA, or RSM, and Inalco SpA, related
to the manufacture and supply of galactooligosaccharides with high purity. Under that Agreement, RSM granted us an exclusive option
to assignment of all “Improved GOS IP,” which we understand to include certain pending patent applications related
to method for the manufacture of highly purified galactooligosaccharides, as used in RP-G28. The Agreement provided for conditions
under which we may exercise that exclusive option. We may be unable to satisfy those conditions. Even if we are able to satisfy
those conditions, the parties to the Agreement may be unwilling to assign the pending application to us. Furthermore, those pending
application may be deemed unpatentable, and therefore never be issue as enforceable patents.
Manufacturing
We
do not own or operate manufacturing facilities for the production of any of our product candidates, nor do we have plans to develop
our own manufacturing operations in the foreseeable future. We currently rely on third-party contract manufacturers for all of
our required raw materials, active pharmaceutical ingredient and finished product for our preclinical research and clinical trials.
We do not have long-term agreements with any of these third parties. We also do not have any current contractual relationships
for the manufacture of commercial supplies of any of our product candidates if they are approved. If any of our products are approved
by any regulatory agency, we intend to enter into agreements with a third-party contract manufacturer and one or more back-up
manufacturers for the commercial production of those products. Development and commercial quantities of any products that we develop
will need to be manufactured in facilities, and by processes, that comply with the requirements of the FDA and the regulatory
agencies of other jurisdictions in which we are seeking approval. We currently employ internal resources to manage our manufacturing
contractors.
Government
Regulation and Product Approval
Governmental
authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other
things, the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing
and export and import of products such as those we are developing. Our product candidates must be approved by the FDA through
the NDA process before they may be legally marketed in the United States and by the EMA through the MAA process before they may
be legally marketed in Europe. Our product candidates will be subject to similar requirements in other countries prior to marketing
in those countries. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state,
local and foreign statutes and regulations require the expenditure of substantial time and financial resources.
United
States Government Regulation
NDA Approval
Processes
In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and implementing regulations.
Failure to comply with the applicable U.S. requirements at any time during the product development process or approval process,
or after approval, may subject an applicant to administrative or judicial sanctions, any of which could have a material adverse
effect on us. These sanctions could include:
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an approval; |
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imposition of
a clinical hold; |
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warning letters;
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product seizures
and/or condemnation and destruction; |
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suspension of production or distribution; or |
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The
process required by the FDA before a drug may be marketed in the United States generally involves the following:
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completion
of nonclinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practices,
or GLPs, or other applicable regulations; |
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submission
to the FDA of an IND, which must become effective before human clinical trials may begin; |
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performance
of adequate and well-controlled human clinical trials according to Good Clinical Practices, or GCPs, to establish the safety
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submission
to the FDA of a NDA; |
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satisfactory
completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance
with current Good Manufacturing Practices, or cGMPs, to assure that the facilities, methods and controls are adequate to preserve
the drug’s identity, strength, quality and purity; and |
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review and approval of the NDA. |
Once
a pharmaceutical candidate is identified for development, it enters the preclinical or nonclinical testing stage. Nonclinical
tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor
must submit the results of the nonclinical tests, together with manufacturing information and analytical data, to the FDA as part
of the IND. Some nonclinical testing may continue even after the IND is submitted. In addition to including the results of the
nonclinical studies, the IND will also include a protocol detailing, among other things, the objectives of the clinical trial,
the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated if the first phase lends itself
to an efficacy determination. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within
the 30-day time period, places the IND on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding
concerns before clinical trials can begin. A clinical hold may occur at any time during the life of an IND, and may affect one
or more specific studies or all studies conducted under the IND.
All
clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCPs. They must
be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject selection and exclusion
criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA as part of the
IND, and progress reports detailing the status of the clinical trials must be submitted to the FDA annually. Sponsors also must
timely report to FDA serious and unexpected adverse reactions, any clinically important increase in the rate of a serious suspected
adverse reaction over that listed in the protocol or investigation brochure, or any findings from other studies or animal or in
vitro testing that suggest a significant risk in humans exposed to the drug. An institutional review board, or IRB, at each institution
participating in the clinical trial must review and approve the protocol before a clinical trial commences at that institution
and must also approve the information regarding the trial and the consent form that must be provided to each research subject
or the subject’s legal representative, monitor the study until completed and otherwise comply with IRB regulations.
Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:
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Phase
1. The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism,
distribution and elimination. In the case of some products for severe or life-threatening diseases, such as cancer, especially
when the product may be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often
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Phase
2. Clinical trials are performed on a limited patient population intended to identify possible adverse effects and safety
risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance
and optimal dosage. Although there are no statutory or regulatory definitions for Phase 2a and Phase 2b, Phase 2a is commonly
used to describe a Phase 2 clinical trial designed to evaluate efficacy, adverse effects and safety risks and Phase 2b is
commonly used to describe a subsequent Phase 2 clinical trial that also evaluates dosage tolerance and optimal dosage. |
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3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population
at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit ratio of
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Adaptive
seamless phase 2b/3 designs, such as the Phase 2b/3 pivotal clinical trial for RP-G28 that we are contemplating, are aimed at
interweaving the two phases of full development by combining them into one single, uninterrupted study conducted in two steps.
Adaptive seamless phase 2b/3 designs enable a clinical trial to be conducted in steps with the sample size calculation selected
on the basis of data observed in the first step to continue along to the second step. The main statistical challenge in such a
design is ensuring control of the type I error rate. Most methodology for such trials is based on the same endpoint being used
for interim and final analyses. A type I error is one in which the adaptation process leads to design, analysis, or conduct flaws
that introduce bias that increases the chance of a false conclusion that a treatment is effective (a type I error). Controlling
type I error can be accomplished by prospectively specifying and including in the statistical analysis plan all possible adaptation
plans that may be considered during the course of the trial. We intend to work with a CRO to determine how best to control type
I error in our Phase 2b/3 study.
Human
clinical trials are inherently uncertain and Phase 1, Phase 2 and Phase 3 testing may not be successfully completed. The FDA or
the sponsor may suspend a clinical trial at any time for a variety of reasons, including a finding that the research subjects
or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical
trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the
drug has been associated with unexpected serious harm to patients.
During
the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior
to the submission of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may be requested. For
instance, we held a Type C meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products on February 20,
2013. The purpose of the meeting was to obtain the FDA’s feedback on the planned clinical development program and future
necessary clinical studies, inform the FDA of our ongoing development plans, gain feedback on relevant clinical trial design and
end points related to patient meaningful benefits, and to inform the FDA of the status of our product characterization. At the
time of our meeting, we were not contemplating an adaptive design Phase 2b/3 clinical trial. Based on RP-G28’s mechanism
of action, data from the Phase 2a clinical study, and further research conducted after the Type C Meeting in early 2013, however,
we now intend to conduct our next clinical trial as an adaptive design Phase 2b/3 clinical trial. We do not intend to request
an additional meeting to seek FDA guidance about this specific clinical development plan.
FDA
meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide
advice on the next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical
results and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the new
drug. If a Phase 2 clinical trial is the subject of discussion at the end of Phase 2 meeting with the FDA, a sponsor may be able
to request a Special Protocol Assessment, or SPA, the purpose of which is to reach agreement with the FDA on the Phase 3 clinical
trial protocol design and analysis that will form the primary basis of an efficacy claim.
According
to published guidance on the SPA process, a sponsor which meets the prerequisites may make a specific request for a SPA and provide
information regarding the design and size of the proposed clinical trial. The FDA is supposed to evaluate the protocol within
45 days of the request to assess whether the proposed trial is adequate, and that evaluation may result in discussions and a request
for additional information. A SPA request must be made before the proposed trial begins, and all open issues must be resolved
before the trial begins. If a written agreement is reached, it will be documented and made part of the record. The agreement will
be binding on the FDA and may not be changed by the sponsor or the FDA after the trial begins except with the written agreement
of the sponsor and the FDA or if the FDA determines that a substantial scientific issue essential to determining the safety or
efficacy of the drug was identified after the testing began.
Concurrent
with clinical trials, sponsors usually complete additional animal safety studies and also develop additional information about
the chemistry and physical characteristics of the drug and finalize a process for manufacturing commercial quantities of the product
in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the
drug and the manufacturer must develop methods for testing the quality, purity and potency of the drug. Additionally, appropriate
packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug candidate does not
undergo unacceptable deterioration over its proposed shelf-life.
The
results of product development, nonclinical studies and clinical trials, along with descriptions of the manufacturing process,
analytical tests and other control mechanisms, proposed labeling and other relevant information are submitted to the FDA as part
of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of user fees, but a waiver
of such fees may be obtained under specified circumstances. The FDA has 60 days from its receipt of an NDA to determine whether
the application will be accepted for filing based on the agency’s threshold determination of whether it is sufficiently
complete to permit substantive review. It may request additional information rather than accept an NDA for filing. In this event,
the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review before the
FDA accepts it for filing.
Once
the submission is accepted for filing, the FDA begins an in-depth review. NDAs receive either standard or priority review. A drug
representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review. The FDA may
refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data.
Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. The FDA
reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its
manufacturing is cGMP-compliant. The FDA may refer the NDA to an advisory committee for review and recommendation as to whether
the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee,
but it generally follows such recommendations. Before approving an NDA, the FDA will inspect the facility or facilities where
the product is manufactured and tested.
Patent
Term Restoration and Marketing Exclusivity
Depending
upon the timing, duration and specifics of FDA marketing approval of RP-G28, one of our U.S. patents may be eligible for limited
patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman
Act. The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost during product
development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent
beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the
time between the effective date of an IND, and the submission date of an NDA, plus the time between the submission date of an
NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the extension and the
application for extension must be made prior to expiration of the patent. The United States Patent and Trademark Office, in consultation
with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply
for restorations of patent term for some of our currently owned or licensed patents to add patent life beyond their current expiration
date, depending on the expected length of clinical trials and other factors involved in the submission of the relevant NDA.
Market
exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides
a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an
NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing
the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity
period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another
company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required
for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or
non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an approved
NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are
deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages or strengths of
an existing drug. This three-year exclusivity covers only the conditions associated with the new clinical investigations and does
not prohibit the FDA from approving ANDAs for drugs containing the original active agent. Five-year and three-year exclusivity
will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct
or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to
demonstrate safety and effectiveness.
Pediatric
Exclusivity and Pediatric Use
Under
the Best Pharmaceuticals for Children Act, or BPCA, certain drugs may obtain an additional six months of exclusivity, if the sponsor
submits information requested in writing by the FDA (a Written Request) relating to the use of the active moiety of the drug in
children. The FDA may not issue a Written Request for studies on unapproved or approved indications or where it determines that
information relating to the use of a drug in a pediatric population, or part of the pediatric population, may not produce health
benefits in that population.
We
have not received a Written Request for such pediatric studies, although we may ask the FDA to issue a Written Request for such
studies in the future. To receive the six-month pediatric market exclusivity, we would have to receive a Written Request from
the FDA, conduct the requested studies in accordance with a written agreement with the FDA or, if there is no written agreement,
in accordance with commonly accepted scientific principles, and submit reports of the studies. A Written Request may include studies
for indications that are not currently in the labeling if the FDA determines that such information will benefit the public health.
The FDA will accept the reports upon its determination that the studies were conducted in accordance with and are responsive to
the original Written Request or commonly accepted scientific principles, as appropriate, and that the reports comply with the
FDA’s filing requirements.
In
addition, the Pediatric Research Equity Act, or PREA, requires all applications (or supplements to an application) submitted under
section 505 of the FDCA (21 U.S.C. §355) for a new active ingredient, new indication, new dosage form, new dosing regimen
or new route of administration to contain a pediatric assessment unless the applicant has obtained a waiver or deferral. It also
authorizes the FDA to require holders of approved NDAs for marketed drugs to conduct pediatric studies under certain circumstances.
In general, PREA applies only to those drugs developed for diseases and/or conditions that occur in both the adult and pediatric
populations. Products intended for pediatric-specific indications will be subject to the requirements of PREA only if they are
initially developed for a subset of the relevant pediatric population.
As
part of the Food and Drug Administration Safety and Innovation Act, Congress reauthorized both BPCA and PREA, which were slated
to expire on September 30, 2012, and made both laws permanent.
Orphan
Drugs
Under
the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition,
defined as a disease or condition with a patient population of fewer than 200,000 individuals in the United States, or a patient
population greater than 200,000 individuals in the United States and when there is no reasonable expectation that the cost of
developing and making available the drug or biologic in the United States will be recovered from sales in the United States for
that drug or biologic.
If
a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for
the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA
may not approve any other applications, including a full NDA, to market the same product for the same indication for seven years,
except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if the
FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities
of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan drug
exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same
drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for
certain research and a waiver of the NDA application user fee.
A
designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication
for which it received orphan designation. Orphan drug exclusive marketing rights in the United States also may be lost if the
FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient
quantities of the product to meet the needs of patients with the rare disease or condition.
We
intend to explore orphan drug designation for RP-G28 for any orphan indication in which there is a medically plausible basis for
treatment of the indication through colonic adaptation of gut bacteria.
Post-approval
Requirements
Once
an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements is not maintained or if problems
occur after the product reaches the market. Later discovery of previously unknown problems with a product may result in restrictions
on the product or even complete withdrawal of the product from the market. After approval, some types of changes to the approved
product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review
and approval. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products that
have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of
these post-marketing programs.
Any
drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including,
among other things:
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providing the
FDA with updated safety and efficacy information; |
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notifying the
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Drug
manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their
establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and some
state agencies for compliance with cGMP and other laws.
We
rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products.
Future FDA and state inspections may identify compliance issues at the facilities of our contract manufacturers that may disrupt
production or distribution, or require substantial resources to correct.
From
time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of products regulated by the FDA. In addition, FDA regulations and guidance
are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible
to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact
of such changes, if any, may be.
Regulation
Outside of the United States
In
addition to regulations in the United States, we will be subject to regulations of other countries governing clinical trials and
commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval
by the comparable regulatory authorities of countries outside of the United States before we can commence clinical trials in such
countries and approval of the regulators of such countries or economic areas, such as the European Union, before we may market
products in those countries or areas. The approval process and requirements governing the conduct of clinical trials, product
licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required
for FDA approval.
Under
European Union regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized
procedure. The centralized procedure, which is compulsory for medicines produced by biotechnology or those medicines intended
to treat AIDS, cancer, neurodegenerative disorders or diabetes and optional for those medicines which are highly innovative, provides
for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure
provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization
may submit an application to the remaining member states. Within 90 days of receiving the applications and assessments report,
each member state must decide whether to recognize approval. If a member state does not recognize the marketing authorization,
the disputed points are eventually referred to the European Commission, whose decision is binding on all member states.
Reimbursement
Sales
of our products will depend, in part, on the extent to which the costs of our products will be covered by third-party payors,
such as government health programs, commercial insurance and managed healthcare organizations. These third-party payors are increasingly
challenging the prices charged for medical products and services. Additionally, the containment of healthcare costs has become
a priority of federal and state governments and the prices of drugs have been a focus in this effort. The U.S. government, state
legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price
controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and
cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could
further limit our net revenue and results. If these third-party payors do not consider our products to be cost-effective compared
to other therapies, they may not cover our products after approved as a benefit under their plans or, if they do, the level of
payment may not be sufficient to allow us to sell our products on a profitable basis.
The
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, imposed new requirements for the distribution
and pricing of prescription drugs for Medicare beneficiaries. Under Part D, Medicare beneficiaries may enroll in prescription
drug plans offered by private entities which will provide coverage of outpatient prescription drugs. Part D plans include both
stand-alone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare Advantage plans. Unlike
Medicare Part A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for
all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and
at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category and class
of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D prescription
drug plan must be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of
prescription drugs may increase demand for our products for which we receive marketing approval. However, any negotiated prices
for our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover,
while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and
payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar
reduction in payments from non-governmental payors.
The
American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different
treatments for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the
Agency for Healthcare Research and Quality and the National Institutes for Health, and periodic reports on the status of the research
and related expenditures will be made to Congress. Although the results of the comparative effectiveness studies are not intended
to mandate coverage policies for public or private payors, it is not clear what effect, if any, the research will have on the
sales of any product, if any such product or the condition that it is intended to treat is the subject of a study. It is also
possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect
the sales of our product candidates. If third-party payors do not consider our products to be cost-effective compared to other
available therapies, they may not cover our products as a benefit under their plans or, if they do, the level of payment may not
be sufficient to allow us to sell our products on a profitable basis.
The
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010
(collectively, the “ACA”), enacted in March 2010, is expected to have a significant impact on the health care industry.
The ACA is expected to expand coverage for the uninsured while at the same time containing overall healthcare costs. With regard
to pharmaceutical products, among other things, the ACA is expected to expand and increase industry rebates for drugs covered
under Medicaid programs and make changes to the coverage requirements under the Medicare Part D program. We cannot predict the
impact of the ACA on pharmaceutical companies, as many of the ACA reforms require the promulgation of detailed regulations implementing
the statutory provisions which has not yet occurred. In addition, some members of the U.S. Congress have been seeking to overturn
at least portions of the legislation and we expect they will continue to review and assess this legislation and alternative health
care reform proposals. Any legal challenges to the ACA, as well as Congressional efforts to repeal the ACA, add to the uncertainty
of the legislative changes enacted as part of the ACA.
In
addition, in some non-U.S. jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed.
The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options
for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement
and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product
or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product
on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical
products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched
in the European Union do not follow price structures of the United States and generally tend to be significantly lower.
Legal
Proceedings
From
time to time, we are involved in various legal proceedings arising in the ordinary course of our business. We are not presently
a party to any legal proceedings the outcome of which, if determined adversely to us, would individually or in the aggregate have
a material adverse effect on our business, operating results or financial condition.
Facilities
On
July 9, 2015, we entered into a new lease with Century Park, pursuant to which we are leasing approximately 2,780 square feet
of office space in Los Angeles, California for our headquarters. The lease provides for a term of sixty-one (61) months, which
commenced October 1, 2015. We paid no rent for the first month of the term and will pay base rent of $9,174 per month for months
two through 13 of the term, with increasing base rent for each twelve month period thereafter under the term of the lease to a
maximum of $10,325 per month for months 50 through 61. We have the option to extend the term of the lease for one five-year term,
provided that the rent would be subject to market adjustment at the beginning of the renewal term. We believe that our facility
is suitable and adequate for our current needs.
Employees
As
of the date of this prospectus, we had seven employees, all of whom were full time employees. None of our employees are represented
by a labor union, and we consider our relationship with our employees to be good.
MANAGEMENT
Executive
Officers and Directors
The
following table sets forth certain information about our executive officers and directors as of the date of this prospectus:
Name |
|
Age |
|
Position(s) |
Executive
Officers: |
|
|
|
|
Michael D. Step |
|
56 |
|
Chief Executive
Officer and Director |
Andrew J. Ritter |
|
33 |
|
President and
Director |
Ira E. Ritter |
|
66 |
|
Executive Chairman,
Chief Strategic Officer and Director |
Ellen Mochizuki |
|
49 |
|
Vice President
Finance |
|
|
|
|
|
Non-Employee
Directors: |
|
|
|
|
Noah Doyle |
|
48 |
|
Director |
Matthew W. Foehr |
|
43 |
|
Director |
Paul V. Maier |
|
68 |
|
Director |
Gerald T. Proehl |
|
56 |
|
Director |
Executive
Officers
Michael
D. Step became our Chief Executive Officer on October 1, 2014. He has served as a director of the Company since 2012.
Mr. Step has over 20 years of business development and corporate development experience in the pharmaceutical industry. Prior
to joining the Company as its Chief Executive Officer, Mr. Step served as Senior Vice President of Corporate Development at Santarus,
Inc., or Santarus, and a member of its executive committee, from 2005 to January 2014, when Santarus was sold to Salix Pharmaceuticals,
Ltd. At Santarus, Mr. Step was responsible for corporate development activities. Prior to joining Santarus, he served as Vice
President, Corporate Development for Amylin Pharmaceuticals, Inc., or Amylin, from 2000 to 2005. In this capacity, he was responsible
for leading corporate development activities, including product licensing, strategic planning, and mergers and acquisitions evaluations.
Before joining Amylin, Mr. Step served as Senior Director, Business Development at Dura Pharmaceuticals, Inc., or Dura Pharmaceuticals,
from 1997 to 2000. In this position, his duties included licensing of marketed pharmaceutical products. Prior to joining Dura
Pharmaceuticals, he served in corporate development and strategic planning at Hoffmann-La Roche, from 1996 to 1997, and held various
sales and management roles at Roche Labs, from 1994 to 1996, and Syntex Labs, from 1992 to 1994. Mr. Step holds a B.A. in political
science from Vanderbilt University and a M.B.A. from the University of Southern California.
Qualifications:
We believe that Mr. Step is well qualified to serve on our board of directors and as Chief Executive Officer of the Company due
to his over 20 years’ experience in the pharmaceutical industry, serving in senior leadership roles within public pharmaceutical
companies including in the gastrointestinal disease segment. Mr. Step has served in various executive management positions in
sales and sales management, many aspects of pharmaceutical commercialization, strategic planning, business development and licensing
providing both strategic and operational vision and guidance. His extensive experience gives him valuable insight into our industry
as well as seasoned business judgment.
Andrew
J. Ritter co-founded the Company in March 2004 and has served as its President and Chief Executive Officer since that
time, until relinquishing the role of Chief Executive Officer to Mr. Step in October 2014. Mr. Ritter has also been a member of
our board of directors since he founded the Company in 2004. Mr. Ritter has been actively studying the field of lactose intolerance
for over 15 years and currently holds six patents and over fifteen pending international patent applications. In addition, he
has co-published articles in Nutrition Journal, Gastroenterology and Food Technology. He has also given presentations at major
healthcare and medical conferences such as Digestive Disease Week, among others, and has been a guest lecturer of entrepreneurship
at various graduate and undergraduate schools throughout Los Angeles including: University of Southern California Marshall School
of Business, University of California at Los Angeles Anderson School of Business and Pepperdine University Graziadio School of
Business and Management. Since 2010, Mr. Ritter has also acted as a managing partner of Stonehenge Partners, a private investment
fund which provides working capital and executive leadership to a variety of businesses and industries including: real estate,
technology, biotechnology, entertainment and service businesses. Mr. Ritter served as a Los Angeles City Commissioner on the Commission
for Children, Youth and Their Families from 2000 to 2002. He holds a B.A. in Political Science and a minor in Business from the
University of Southern California and was a member of the 2002 Pac-10 Championship baseball team. He graduated from the Stanford
Graduate School of Business’ Executive Education on Influence and Negotiation Strategies.
Qualifications:
We believe that Mr. Ritter is well qualified to serve on our board of directors due to his over 15 years of research experience
working in lactose intolerance and digestive diseases. Having founded the Company and invented Lactagen™, Mr.
Ritter has an in depth knowledge of the Company, and provides senior leadership on the clinical and product development matters
facing the Company. Mr. Ritter also brings to the board of directors an extensive scientific and operational background gained
previously at Ritter Natural Sciences and over the years at Ritter Pharmaceuticals, Inc.
Ira
E. Ritter has served as our Co-Founder, Chief Strategic Officer and Executive Chairman of the board of directors since
2004. Mr. Ritter has extensive experience creating and building diverse business enterprises and has provided corporate management,
strategic planning and financial consulting for a wide range of market segments. Since 2010, Mr. Ritter has also acted as a managing
partner of Stonehenge Partners. Mr. Ritter served as President and Vice Chairman of Quality King, Inc., a national wholesale distributor
of healthcare products, from 1992 to 2000. From 1998 to 2001, he served as President and Chairman of Rockwood Investments Inc.,
a business he developed which produced private label health and beauty products for major national retailers, including GNC and
K-Mart. He also served as Chairman of ON-TV, a division of Oak Industries, Inc., from 1982 to 1985, where he managed the television
division initiating exclusive broadcasts of Los Angeles, Chicago, and New York professional baseball, basketball, and hockey games.
During this tenure, he produced the first televised home shopping program and directed development of the largest “pay-per-view”
channel system for its time. Mr. Ritter served on the board of directors for Martin Lawrence Art Galleries from 1980 to 1985 helping
take it public on The New York Stock Exchange. During his 20 years as a publisher, he produced monthly national consumer magazines
focused on health & fitness, women’s issues and the environment. Mr. Ritter also has a long history of public service
that includes appointments by three Governors to several State of California Commissions including eight years served as Commissioner
on the California Prison Industry Authority. He has guest lectured at University of Southern California Marshall School of Business
and Pepperdine University Graziadio School of Business where he also serves as an advisory board member to Pepperdine’s
Graduate School of Education and Psychology, Social Entrepreneurship and Change Program. Presently he serves on the board of directors
for Vitavis Laboratories. In 1981, Mr. Ritter was honored with the City of Hope’s Man of the Year award.
Qualifications:
We believe that Mr. Ritter is well suited to serve on our board of directors due to his over 40 years’ experience overseeing
daily operations of diverse business enterprises, and his managing public as well as private companies. Mr. Ritter provides our
board of directors with extensive background in operational and strategic planning, as well as general executive and leadership
expertise. Mr. Ritter has served on the boards of several companies during his career.
Ellen
Mochizuki has served as our Vice President, Finance since September 18, 2015. From August 2014 to June 2015, Ms. Mochizuki
consulted with various biopharmaceutical clients with respect to their initial public offerings and related financial statements.
From 2007 to 2014, she was a Director of Accounting (Benefits) for Northrop Grumman Corporation, or NGC, and was responsible for
the overall accounting and accounting operations of its benefit assets. From 2006 to 2007, Ms. Mochizuki consulted with NGC. From
2002 to 2005, she was a Senior Vice President at IndyMac Bank, overseeing human resources operations. Ms. Mochizuki started her
career as an auditor with PricewaterhouseCoopers. Ms. Mochizuki is an adjunct faculty at Pasadena City College teaching accounting
(2014 to present) and is licensed in the State of California as a certified public accountant though is currently on inactive
status.
Non-Employee
Directors
Noah
Doyle has served as a director of the Company since September 2008. He has been an entrepreneur and investor for over
20 years. Mr. Doyle is the managing director of Javelin Venture Partners GP, LLC, the general partner of Javelin Venture partners
GP, L.P., which is the general partner of Javelin and the manager of Javelin SPV. Prior to forming the first Javelin entities
in 2008, Mr. Doyle supported over a dozen start-ups as an angel investor, including Keyhole, Inc., or Keyhole, (acquired by Google
Inc. in 2004), Cantametrix, Inc. (acquired by Gracenote, Inc. in 2002), Amae Software (acquired by Verint Systems, Inc. in 2006),
Nuvon, Inc., Aquea Scientific Corporation, Emdigo Inc., Magnacash Inc. (acquired by Yaga, Inc. in 2001), and i-mint India. Mr.
Doyle most recently directed the enterprise product line for Google’s geospatial products, Google Earth and Google Maps,
from 2004 to 2007. From 2002 to 2004 he managed the Sales and Corporate Development functions at Keyhole, which created the first
Web hosted digital earth model. Prior to Keyhole, Mr. Doyle helped establish the Internet loyalty rewards marketplace as a co-founder
of MyPoints.com, or MyPoints, the largest Internet loyalty program with over 6 million active members, where he led product management
and business development functions from the company’s inception in 1996 through its initial public offering and subsequent
acquisition by United Airlines in 2002. Prior to joining MyPoints, Mr. Doyle was based in Tokyo where he managed overseas sales
and marketing for the OEM channel of Matsushita’s (Panasonic) communications equipment subsidiary in Japan, from 1990 to
1994. He was chairman of the management board of the University of California, Berkeley’s campus bookstore, a $17 million
retail operation, and also held product management and operations management roles at IBM/Rational (Pure Atria) and Oracle, from
1989 to 1990. Mr. Doyle holds M.B.A. and B.A. Economics degrees, as well as certificates in Management of Technology and Global
Management from University of California — Berkeley.
Qualifications:
We believe that Mr. Doyle is well suited to serve on our board of directors due to his over 20 years of experience as an entrepreneur
and investor. Mr. Doyle has experience as a venture capitalist building and serving on the boards of many public and private emerging
companies in leadership roles providing guidance on finance, development and operational growth. Mr. Doyle holds an M.B.A, as
well as certificates in Management of Technology and Global Management from University of California — Berkeley.
Matthew
W. Foehr has served as a director of the Company since February 1, 2015. He currently serves as President and Chief Operating
Officer at Ligand Pharmaceuticals Incorporated. Prior to joining Ligand in 2011, Mr. Foehr was Vice President and Head of Consumer
Dermatology R&D, as well as Acting Chief Scientific Officer of Dermatology, in the Stiefel division of GlaxoSmithKline, or
GSK. Following GSK’s acquisition of Stiefel in 2009, Mr. Foehr led the R&D integration of Stiefel into GSK. At Stiefel
Laboratories, Inc., Mr. Foehr served as Senior Vice President of Global R&D Operations, Senior Vice President of Product Development
& Support, and Vice President of Global Supply Chain Technical Services. Prior to Stiefel, Mr. Foehr held various executive
roles at Connetics Corporation including Senior Vice President of Technical Operations and Vice President of Manufacturing. Currently,
he is a member of the board of directors of Viking Therapeutics Inc. Mr. Foehr is the author of multiple scientific publications
and is a named inventor on numerous U.S. patents. He received his Bachelor of Science degree in Biology from Santa Clara University.
Qualifications:
We believe that Mr. Foehr is well suited to serve on our board of directors due to his more than 20 years of experience in the
pharmaceutical industry and his experience managing global operations and research and development programs.
Paul
V. Maier has served as a director of the Company since April 9, 2015. From November 2009 through June 2014, Mr. Maier
served as the Chief Financial Officer of Sequenom Inc., a publicly held company serving the discovery, clinical research, and
diagnostics market. From February 2007 until November 2009, he served as an independent financial consultant. Previously, Mr.
Maier was Senior Vice President and Chief Financial Officer of Ligand Pharmaceuticals Inc., a commercial stage biopharmaceutical
company, a position he held from 1992 through 2007. From 1990 to 1992, Mr. Maier served as Vice President, Finance of DFS West,
a division of DFS Group LP, a private multinational retailer. From 1984 to 1990, Mr. Maier was employed by ICN Pharmaceuticals,
a pharmaceutical and biotechnology research products company, where he held various executive positions in finance and general
management in ICN as well as SPI Pharmaceuticals, a publicly held subsidiary. Mr. Maier currently serves on the Board of Directors
of International Stem Cell Corporation, Apricus Biosciences, MabVax Therapeutics, and Biological Dynamics. Mr. Maier received
an MBA from Harvard Business School and a BS from Pennsylvania State University.
Qualifications:
We believe that Mr. Maier is well suited to serve on our board of directors due to his over 25 years of experience as a senior
executive in biotechnology and pharmaceutical companies and his extensive experience in finance.
Gerald
T. Proehl has served as a director of the Company since April 2014. Currently, Mr. Proehl
is President, CEO, Founder and Director of Dermata Therapeutics, LLC, a private biopharmaceutical company. From January
2002 to January 2014, he was the President, Chief Executive Officer and a Director of Santarus, Inc. (“Santarus”),
a company that he helped to found in 1999 and sold to Salix Pharmaceuticals in January 2014 for $2.6 billion. From March 2000
through December 2001, Mr. Proehl was President and Chief Operating Officer of Santarus, and from April 1999 to March 2000, Mr.
Proehl was Vice President, Marketing and Business Development of Santarus. Prior to joining Santarus, Mr. Proehl was with Hoechst
Marion Roussel, Inc. (“Hoechst”), a global pharmaceutical company, for 14 years, where he served in various capacities,
including Vice President of Global Marketing. During his career at Hoechst he worked across numerous therapeutic areas, including
CNS, cardiovascular, and gastrointestinal. Mr. Proehl currently serves on the board of directors of two other public company boards,
Sophiris Bio Inc. and Tenax Therapeutics, Inc. Mr. Proehl also serves on a number of private company boards including Kinetek
Sports, Patara Pharma LLC, MDRejuvena, Inc. and Dermata Therapeutics, LLC. He also served on the board of directors of Auspex
Pharmaceuticals, Inc. from January 2014 to May 2015. Mr. Proehl holds a B.S. in education from the State University of New York
at Cortland, an M.A. in exercise physiology from Wake Forest University and an M.B.A. from Rockhurst College.
Qualifications:
We believe that Mr. Proehl is well suited to serve on our board of directors due to his general business and commercial experience
in the pharmaceutical industry, as well as his strong background in business operations developed through his leadership at other
companies.
Medical
Advisory Board
Roger
Clemens, Ph.D., Adjunct Professor in Pharmacology and Pharmaceutical Sciences at University of Southern California’s
School of Pharmacy, is one of the world’s leading experts in human nutrition. Dr. Clemens joined the USC School of Pharmacy
after serving as the Scientific Advisor for Nestlé USA for more than 20 years. Dr. Clemens spent much of his career in
industry working as scientific advisor for Carnation/Nestlé USA from 1978 – 1999. He has published
more than 30 original manuscripts and participated in more than 70 invited lectures on the topics of food science and nutrition.
Dr. Clemens has served as an expert panel member for the FDA, International Food Information Council, California Dairy Council,
and the Life Sciences Research Organization. Dr. Clemens is an active leader and professional member of the Institute of Food
Technologists. He is also a member of the American Institute of Nutrition and a Fellow of the American College of Nutrition. Dr.
Clemens holds both doctorate and master’s degrees of Public Health in Nutrition from UCLA.
Byron
L. Cryer, M.D., Professor of Medicine in the Division of Digestive and Liver Diseases and an Associate Dean at the University
of Texas Southwestern Medical Center at Dallas and the North Texas VA Health Care System, is active in the gastroenterology professional
associations and was an associate chairman of the Esophagus, Stomach, and Duodenum section of the American Gastroenterological
Association. His clinical interests are in general gastroenterology. Dr. Cryer’s specific areas of interest are acid-peptic
diseases of the upper gastrointestinal tract. His primary research interest has been in the pathogenesis of peptic ulcer disease.
His research focus has been clinically oriented in that he has exclusively studied the pathophysiology of these processes in humans.
Dr. Cryer has distinguished himself as an internationally recognized clinical investigator and thought leader in the field of
the gastrointestinal adverse effects of medications. Most of this focus has been to study the gastrointestinal consequences of
aspirin and the non-steroidal anti-inflammatory drugs (NSAIDS). Among the contributions which Dr. Cryer has made to the area of
medication-induced gastrointestinal disease, his most recent contributions have been in the evaluation of COX-2 specific inhibitors
as a strategy to improve the gastrointestinal safety of NSAIDS. Additionally, he has regulatory experience having served a five
year term as a member of the FDA Advisory Committee for Gastrointestinal Drugs and as a Special Government Consultant to the Center
for Drug Evaluation Research in Gastrointestinal Drugs. Dr. Cryer holds an M.D. degree from the Baylor college of Medicine and
a bachelor’s degree from Harvard University. Dr. Cryer completed his gastroenterology fellowship training at the University
of Texas Southwestern Medical Center.
Harry
Greene, M.D., Professor Emeritus of Pediatrics and Biochemistry/Nutrition at Vanderbilt School of Medicine, served as
chief, Division of Pediatric Gastroenterology/Nutrition and director of the NIH sponsored Clinical Nutrition Research Unit at
Vanderbilt. He is currently Visiting Professor of Medicine (Endocrinology) at the University of Kentucky and has served on multiple
advisory boards for the NIH. He is a past President of the American Society of Clinical Nutrition and the North American Society
of Pediatric Gastroenterology, Nutrition and Liver Disease. He has authored over 200 publications in medical journals and continues
to consult on issues of obesity management and nutrition. In 1993, Dr. Greene moved to the private sector first as senior director
of Nutritional Sciences for Bristol Myers Squibb/Mead Johnson and later as vice president and medical director for Unilever/Slim-Fast
Foods Company, West Palm Beach, FL. He retired from Unilever in 2003.
Warren
Grundfest, M.D., FACS, Professor Department of Bioengineering, Electrical Engineering and Surgery at University of California,
Los Angeles, currently serves as a professor in the department of bioengineering, electrical engineering and surgery at UCLA.
In 2008, he was selected as one of 100 notable people in the medical device industry by MDDI magazine published by Cannon Communications.
He has also served as a consultant to the FDA Office of Device Evaluation and Office of Science and Engineering. In 1995, Dr.
Grundfest was appointed as a research professor of biomedical engineering at the University of Southern California and as a visiting
associate in mechanical engineering at California Institute of Technology (Caltech). Dr. Grundfest served as director of the Cedars-Sinai
Laser Research and Technology Development Program from 1989 to 2001, holding the Dorothy and E. Philip Lyon Chair in Laser Research.
Dr. Grundfest was appointed assistant director of surgery and assistant clinical professor of surgery at UCLA in 1987. Dr. Grundfest
received his MD degree from Columbia University, College of Physicians and Surgeons and trained in General Surgery at UCLA and
Cedars-Sinai Medical Center.
Todd
Klaenhammer, Ph.D., Director of the Southeast Dairy Foods Research Center and Distinguished University Professor and William
Neal Reynolds Professor Food Microbiology, Genetics, Genomics, Bioprocessing and Fermentation at North Carolina State University,
has directed research programs on the genetics of lactic acid bacteria used as probiotics or as starter cultures for food bioprocessing
and biotechnology applications for thirty years. He is a fellow in the American Academy of Microbiology, the Institute of Food
Technologists, the American Dairy Science Association and the American Association for the Advancement of Science. In 2001, he
was elected into the National Academy of Sciences.
William
J. Sandborn, M.D., Chief, Division of Gastroenterology and Director at University of California San Diego Inflammatory
Bowel Disease Center and Professor of Clinical Medicine. He has published more than 408 articles including articles in the New
England Journal of Medicine, the Lancet, JAMA, the Annals of Internal Medicine, and Gastroenterology. His research includes clinical
development and clinical pharmacology related to inflammatory bowel disease. From April 1993 to December 2010, Dr. Sandborn was
head of the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN and from January 2011 to present, the Division
of Gastroenterology, University of California San Diego, La Jolla. Dr. Sandborn is extremely well regarded and well known within
the investment community and is considered one of the key leading gastroenterologists in the United States for pharmaceutical
research and clinical trial work.
Dennis
Savaiano, Ph.D., Professor of Foods and Nutrition and Former Dean at Purdue University, has researched lactose intolerance
for the past 20 years, where he has attempted to identify the dietary factors that can improve lactose tolerance. Formerly, he
served as the associate dean and assistant director of the Agricultural Experiment Station Human Ecology at the University of
Minnesota. Dr. Savaiano is a native Californian with degrees from Claremont McKenna College (BA in Biology) and the University
of California at Davis (MS and PhD in Nutrition). He was a Professor in the Department of Food Science and Nutrition at the University
of Minnesota from 1980 through 1995, and moved to Purdue University in 1995.
W.
Allan Walker, M.D., Director of the Division of Nutrition at Harvard Medical School, has a longstanding interest and commitment
to nutrition research, particularly on the role of nutritional factors in maintaining the integrity of the intestinal mucosal
barrier to host defense during the perinatal period. He was the first recipient of the Conrad Taff Professorship in Nutrition
at Harvard Medical School in 1990. The research efforts of his laboratory have contributed substantially to a better understanding
of the role of breast milk and its inherent growth factors on the development of the gastrointestinal tract and the role of short
and long term malnutrition on the integrity of the mucosal barrier to host defense against bacterial colonization and against
the uptake of macromolecules (antigens and toxins) which may result in neonatal and childhood intestinal disease states (necrotizing
enterocolitis and gastrointestinal allergy). He served for six years on the Committee of Nutrition of the American Academy of
Pediatrics (1977 – 1983) and received the Nutrition Research Award (Borden Award) of the American Academy
of Pediatrics in 1984 and the Hugh Butt Award for Excellence in Clinical Nutrition Research from the American Gastroenterologic
Association in 1998. He has also served on Nutrition study sections at the NICHD and NIDDK institutes and the Advisory Council
of NIDDK at NIH and recently served as a member of the task force to establish a five-year nutrition research plan at NICHD. Dr.
Walker is the author of 12 textbooks and over 500 research and review articles.
Composition
of our Board of Directors
Our
board of directors currently consists of seven members, four of whom are non-employee directors. Our directors hold office until
their successors have been elected and qualified or until the earlier of their death, resignation or removal. There are no family
relationships among any of our directors or executive officers, other than Ira and Andrew Ritter, who are father and son.
Our
amended and restated bylaws provides that the authorized number of directors comprising our board of directors shall be fixed,
from time to time, by a majority of the total number of directors.
Director
Independence
Under
Rules 5605 and 5615 of NASDAQ’s continued listing requirements, a majority of a listed company’s board of directors
must be comprised of independent directors, subject to certain exceptions and phase-in rules. In addition, NASDAQ’s continued
listing requirements require that, subject to certain exceptions and phase-in rules, each member of a listed company’s audit,
compensation and governance and nominating committees must be independent. Audit committee members must also satisfy the independence
criteria set forth in Rule 10A-3 under the Exchange Act (subject to certain phase-in rules). Under Rule 5605(a)(2) of NASDAQ’s
continued listing requirements, a director will only qualify as an “independent director” if, in the opinion of that
company’s board of directors, that person does not have a relationship that would interfere with the exercise of independent
judgment in carrying out the responsibilities of a director.
Based
upon information requested from and provided by each director concerning their background, employment and affiliations, including
family relationships, our board of directors has determined that each of Messrs. Doyle, Foehr, Maier and Proehl are independent
under the applicable rules and regulations of the NASDAQ Stock Market. In making such determinations, the board of directors considered
the relationships that each such non-employee director has with our company and all other facts and circumstances the board of
directors deemed relevant in determining their independence.
Board
Diversity
Upon
completion of our initial public offering, our nominating and governance committee will be responsible for reviewing with the
board of directors, on an annual basis, the appropriate characteristics, skills and experience required for the board of directors
as a whole and its individual members. In evaluating the suitability of individual candidates (both new candidates and current
members), the nominating and corporate governance committee, in recommending candidates for election, and the board of directors,
in approving (and, in the case of vacancies, appointing) such candidates, will take into account many factors, including the following:
|
● |
diversity
of personal and professional background, perspective, experience, age, gender, ethnicity and country of citizenship; |
|
|
|
|
● |
personal
and professional integrity and ethical values; |
|
|
|
|
● |
experience
in one or more fields of business, professional, governmental, scientific or educational endeavors, and a general appreciation
of major issues facing public companies similar in scope and size to us; |
|
|
|
|
● |
experience
relevant to our industry or with relevant social policy concerns; |
|
|
|
|
● |
relevant
academic expertise or other proficiency in an area of our operations; |
|
|
|
|
● |
objective
and mature business judgment and expertise; and |
|
|
|
|
● |
any
other relevant qualifications, attributes or skills. |
Committees
of the Board of Directors
Our
board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee.
Each committee operates under a charter. Copies of each committee’s charter are posted on the Investor Relations section
of our website, which is located at www.ritterpharmaceuticals.com. The composition and function of each of these committees
are described below.
Audit
Committee. NASDAQ rules require that each listed company must have an audit committee of at least three members, each
of whom must: (i) be “independent” as defined under NASDAQ Rule 5605(a)(2) (subject to limited exceptions, including
the phase-in rules described above); (ii) meet the criteria for independence set forth in Rule 10A-3(b)(1) under the Exchange
Act (subject to certain exemptions in including the phase-in rules described above); (iii) not have participated in the preparation
of the financial statements of the company or any current subsidiary of the company at any time during the past three years; and
(iv) be able to read and understand fundamental financial statements, including a company’s balance sheet, income statement,
and cash flow statement. Additionally, each company must certify that it has, and will continue to have, at least one member of
the audit committee who has past employment experience in finance or accounting, requisite professional certification in accounting,
or any other comparable experience or background which results in the individual’s financial sophistication, including being
or having been a chief executive officer, chief financial officer or other senior officer with financial oversight responsibilities.
The
current members of our audit committee are Matthew Foehr, Paul Maier and Gerald Proehl, with Mr. Maier serving as chairman. Our
board of directors has determined that each member of our audit committee is independent under Rule 10A-3 of the Exchange Act
and the applicable listing requirements of NASDAQ, and that each member of our audit committee satisfies the other listing requirements
of NASDAQ for audit committee membership. Our board of directors has also determined that Mr. Maier qualifies as an “audit
committee financial expert,” as such term is defined by the SEC, and that he has the requisite level of financial sophistication
required by the continued listing standards of NASDAQ.
Under
the audit committee charter, our audit committee is authorized to take the following actions, among others:
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approve and retain
the independent auditors to conduct the annual audit of our financial statements; |
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review the proposed
scope and results of the audit; |
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review and pre-approve
audit and non-audit fees and services; |
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review accounting
and financial controls with the independent auditors and our financial and accounting staff; |
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review and approve
transactions between us and our directors, officers and affiliates; |
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recognize and
prevent prohibited non-audit services; |
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establish procedures
for complaints received by us regarding accounting matters; |
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oversee internal
audit functions, if any; and |
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prepare the report
of the audit committee that the rules of the SEC require to be included in our annual meeting proxy statement. |
Compensation
Committee. NASDAQ rules require that each listed company have a compensation committee comprised of at least two members,
each of whom is independent under NASDAQ’s general director independence requirements and meets the enhanced independence
requirements for compensation committee members set forth in NASDAQ Rule 5605(d)(2)(A).
The
current members of our compensation committee are Matthew Foehr, Paul Maier and Gerald Proehl, with Mr. Foehr serving as chairman.
Our board of directors has determined that each member of our compensation committee is independent under the applicable listing
requirements of NASDAQ.
Under
the compensation committee charter, our compensation committee is authorized to take the following actions, among others:
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review
and recommend the compensation arrangements for management, including the compensation for our president and chief executive
officer; |
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establish
and review general compensation policies with the objective to attract and retain superior talent, to reward individual performance
and to achieve our financial goals; |
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administer
our stock incentive plans; and |
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prepare
the report of the compensation committee that the rules of the SEC require to be included in our annual meeting proxy statement.
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Nominating
and Corporate Governance Committee. NASDAQ does not require a separate nominations committee. However, if a company does
not have a separate committee, certain nominating decisions must be made by a majority of the independent directors of the board.
The
current members of our nominating and corporate governance committee are Noah Doyle, Paul Maier and Gerald Proehl, with Mr. Proehl
serving as chairman. Our board of directors has determined that each member of our nominating and corporate governance committee
is independent under the applicable listing requirements of NASDAQ.
Under
the nominating and corporate governance committee charter, our nominating and corporate governance committee is authorized to
take the following actions, among others:
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identify and nominate
members of the board of directors; |
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develop and recommend
to the board of directors a set of corporate governance principles applicable to our company; and |
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oversee the evaluation
of our board of directors. |
Compensation
Committee Interlocks and Insider Participation
No
member of our compensation committee has at any time been an employee of ours. None of our executive officers serves as a member
of another entity’s board of directors or compensation committee that has one or more executive officers serving as a member
of our board of directors or compensation committee.
Code
of Business Conduct and Ethics
We
adopted a code of business conduct and ethics that applies to all of our employees, officers and directors, including those officers
responsible for financial reporting prior to the closing of our initial public offering. The code of business conduct and ethics
is available on our website at www.ritterpharmaceuticals.com. Any amendments to the code, or any waivers of its requirements,
will be disclosed on our website.
Board
of Directors Leadership Structure
Our
Chief Strategic Officer also serves as the Executive Chairman of our board of directors. Our board of directors does not have
a lead independent director. Our board of directors has determined its leadership structure is appropriate and effective for us
at this time, given our stage of development.
Board’s
Role in Risk Oversight
Risk
is inherent with every business, and how well a business manages risk can ultimately determine its success. We face a number of
risks, including risks relating to product candidate development, technological uncertainty, dependence on collaborative partners
and other third parties, uncertainty regarding patents and proprietary rights, comprehensive government regulations, having no
commercial manufacturing experience, marketing or sales capability or experience and dependence on key personnel, as more fully
discussed under “Risk Factors” in this prospectus. Management is responsible for the day-to-day management of risks
we face, while our board of directors, as a whole and through its committees, has responsibility for the oversight of risk management.
In its risk oversight role, our board of directors has the responsibility to satisfy itself that the risk management processes
designed and implemented by management are adequate and functioning as designed.
Our
board of directors is actively involved in oversight of risks that could affect us. This oversight is conducted primarily through
committees of the board of directors, but the full board of directors has retained responsibility for general oversight of risks.
Our board of directors satisfies this responsibility through full reports by each committee chair regarding the committee’s
considerations and actions, as well as through regular reports directly from officers responsible for oversight of particular
risks within our company as our board of directors believes that full and open communication between management and the board
of directors is essential for effective risk management and oversight.
Limitation
of Directors’ and Officers’ Liability and Indemnification
The
Delaware General Corporation Law authorizes corporations to limit or eliminate, subject to specified conditions, the personal
liability of directors to corporations and their stockholders for monetary damages for breach of their fiduciary duties. Our amended
and restated certificate of incorporation limits the liability of our directors to the fullest extent permitted by Delaware law.
We
have obtained director and officer liability insurance to cover liabilities our directors and officers may incur in connection
with their services to us. Our amended and restated certificate of incorporation and amended and restated bylaws also provide
that we will indemnify and advance expenses to any of our directors and officers who, by reason of the fact that he or she is
one of our officers or directors, is involved in a legal proceeding of any nature. We will repay certain expenses incurred by
a director or officer in connection with any civil, criminal, administrative or investigative action or proceeding, including
actions by us or in our name. Such indemnifiable expenses include, to the maximum extent permitted by law, attorney’s fees,
judgments, fines, ERISA excise taxes, penalties, settlement amounts and other expenses reasonably incurred in connection with
legal proceedings. A director or officer will not receive indemnification if he or she is found not to have acted in good faith
and in a manner he or she reasonably believed to be in, or not opposed to, our best interest.
We
have entered into indemnification agreements with each of our directors and certain of our officers. These agreements provide
that we will, among other things, indemnify and advance expenses to our directors and officers for certain expenses, including
attorneys’ fees, judgments, fines and settlement amounts incurred by any such person in any action or proceeding, including
any action by us arising out of such person’s services as our director or officer, or any other company or enterprise to
which the person provides services at our request. We believe that these provisions and agreements are necessary to attract and
retain qualified persons as directors and officers.
Such
limitation of liability and indemnification does not affect the availability of equitable remedies. In addition, we have been
advised that in the opinion of the SEC, indemnification for liabilities arising under the Securities Act is against public policy
as expressed in the Securities Act and is therefore unenforceable.
There
is no pending litigation or proceeding involving any of our directors, officers, employees or agents in which indemnification
will be required or permitted. We are not aware of any threatened litigation or proceeding that may result in a claim for such
indemnification.
EXECUTIVE
AND DIRECTOR COMPENSATION
Summary
Compensation Table (2015 and 2014)
The
following table sets forth the compensation paid or earned for the fiscal years ended December 31, 2015 and 2014 to our named
executive officers for each of those years, who are comprised of (1) our principal executive officer for such year, and
(2) our next two highest compensated executive officers other than the principal executive officer (whose compensation exceeded
$100,000).
Name and Principal
Position | |
Year | | |
Salary
($) | | |
Bonus ($) | | |
Option
Awards(1) ($) | | |
Nonequity
Incentive
Compensation
($) | | |
All
Other Compensation
($) | | |
Total
($) | |
Michael D. Step | |
| 2015 | | |
$ | 348,692 | | |
$ | — | | |
$ | — | | |
| — | | |
$ | — | | |
$ | 348,692 | |
Chief Executive
Officer | |
| 2014 | | |
$ | 90,000 | | |
$ | — | | |
$ | 2,332,410 | | |
| — | | |
$ | — | | |
$ | 2,422,410 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
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Andrew J. Ritter | |
| 2015 | | |
$ | 259,260 | | |
$ | | (2) | |
$ | — | | |
| 225,000 | (3) | |
$ | 109,952 | (4) | |
$ | 594,212 | |
President | |
| 2014 | | |
$ | 204,070 | | |
$ | — | | |
$ | 1,253,638 | | |
| — | | |
$ | 7,428 | | |
$ | 1,465,136 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
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Ira E. Ritter | |
| 2015 | | |
$ | 249,980 | | |
$ | | (2) | |
$ | — | | |
| 225,000 | (3) | |
$ | 7,157 | (4) | |
$ | 482,137 | |
Executive Chairman
and | |
| 2014 | | |
$ | 182,922 | | |
$ | — | | |
$ | 1,253,638 | | |
| — | | |
$ | 13,082 | | |
$ | 1,449,642 | |
Chief Strategic
Officer | |
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(1) |
Represents
the aggregate grant date fair value of awards computed in accordance with FASB ASC Topic 718. For a discussion of the assumptions
and methodologies used to value the options awards granted, see Note 8 – “Stock Based Compensation” to our
accompanying financial statements in this prospectus. |
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(2) |
Pursuant
to their respective offer letters, Andrew Ritter and Ira Ritter each have the opportunity to earn an annual bonus based upon
a percentage of their base salary and the achievement of specific performance goals. The initial target bonus opportunities
are 40% and 35% of the base salary for Andrew Ritter and Ira Ritter, respectively. For 2015 performance, bonus amounts have
not been determined. Such bonus amounts are expected to be determined during the first quarter of 2016. |
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(3) |
Represents
cash bonuses of $75,000 and $150,000 attributable to the Clinical Trial Funding Commitment Bonus Opportunities and the Fundraising
Bonus Opportunities, respectively, paid to each of Andrew Ritter and Ira Ritter. |
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(4) |
Represents
auto allowances of $4,952 and $7,157 paid on behalf of Andrew Ritter and Ira Ritter, respectively. Also represents $105,000
paid as tuition reimbursement pursuant to Andrew Ritter’s offer letter. |
Narrative
to Summary Compensation Table
Letter
Agreement with Michael D. Step
On
December 2, 2014, we entered into a letter agreement, or the Step Letter Agreement, with Mr. Step, our current Chief Executive
Officer, setting forth the terms of his employment. The Step Letter Agreement provides that Mr. Step will be entitled to an annual
base salary of $360,000. Pursuant to the Step Letter Agreement, Mr. Step was also entitled to receive three stock options.
The
first two options entitle Mr. Step to purchase 646,537 and 73,377 shares of common stock of the Company, respectively, for an
exercise price of $5.86 per share. Each of these options is immediately exercisable in full as of the date of the grant,
with 44/48ths of the total number of shares covered by each option subject to a right of repurchase by the Company
upon termination of Mr. Step’s employment with us for any reason. This right of repurchase will lapse over a period of 44
months, with 1/44th of the total number of shares subject to the right of repurchase lapsing on January 1, 2015 and
on the first day of each month thereafter. In addition, the right of repurchase will lapse in its entirety upon a termination
of the employment of Mr. Step by us without Cause or by Mr. Step with Good Reason and upon a Termination upon a Change in Control
Agreement.
The
third option became exercisable upon the closing of our initial public offering on June 29, 2015. Pursuant to the terms of the
agreement, the option is exercisable for a total of 163,799 shares of our common stock, which, together with the shares subject
to the first option, represent 7.5% of the shares of common stock deemed to be outstanding at June 29, 2015 on a fully-diluted
basis, after giving effect to the number of shares subject to the third option. Seventy-five percent of the shares subject to
the third option are subject to a right of repurchase by us upon termination of Mr. Step’s employment for any reason. This
right of repurchase will lapse with respect to 1/36th of the total number of shares subject to the right of repurchase
on the first day of each month following the date on which the third option first becomes exercisable. In addition, the right
of repurchase will lapse in its entirety upon Mr. Step’s termination of employment under certain circumstances.
For
purposes of the Step Letter Agreement, the terms “Cause,” “Good Reason,” and “Termination upon a
Change in Control” each have the meanings ascribed to such terms in the Executive Severance & Change in Control Agreement
described below.
Compensation
Arrangements with Andrew Ritter and Ira Ritter
On
September 25, 2013, our board of directors approved the Executive Compensation Plan setting forth certain compensation to be paid
to Andrew Ritter and Ira Ritter for their contributions to the Company. Effective June 29, 2015, in connection with our initial
public offering, Andrew Ritter and Ira Ritter accepted offer letters from us setting for the terms of their employment as President
and Chief Strategic Officer, respectively. The offer letter superseded the Executive Compensation Plan.
Executive
Compensation Plan
Pursuant
to the terms of the Executive Compensation Plan Andrew Ritter’s salary was $225,000 per year and Ira Ritter’s salary
was $210,000 per year. Andrew Ritter was entitled to an annual car allowance of up to $8,400 and Ira Ritter was entitled to an
annual car allowance of up to $12,000. Any car allowance claimed by Andrew or Ira Ritter would result in an automatic reduction
in such person’s base salary then in effect.
Under
the Executive Compensation Plan, each of Andrew and Ira Ritter had bonus opportunities to receive cash payments and options to
purchase up to 48,951 shares of the Company’s common stock (each referred to in this section as an “Executive Option
Grant”) as described below. On December 2, 2014, they also each received an option to purchase up to 432,434 shares of the
Company’s common stock. See “Outstanding Equity Awards at Fiscal Year-End” for additional information regarding
these options.
Pursuant
to the terms of the Executive Compensation Plan, Andrew and Ira Ritter were entitled to the following cash and equity payments
upon the satisfaction of the events described below:
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FDA
Meeting Bonus Opportunities. In April 2013, Andrew and Ira Ritter each received a one-time cash bonus of $10,000
for meeting with the FDA regarding RP-G28’s pathway to FDA approval. Upon satisfaction of this milestone, 2,360 shares
under the Executive Option Grant vested and became exercisable as of September 25, 2013. An additional 1,136 shares were to
vest ratably on a monthly basis beginning on September 30, 2013. |
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Clinical
Trial Funding Commitment Bonus Opportunities. Pursuant to the terms of the Executive Compensation Plan, Andrew and Ira
Ritter were each entitled to receive a one-time cash bonus of $75,000 upon the Company’s receipt of a commitment by
a third party to fund a Phase 2 or later clinical trial whether or not any such committed funds were paid directly to the
Company; provided, however, that no such bonus would be paid at any time the Company has less than $2,000,000 in available
cash. In addition, the Executive Compensation Plan provided that upon the satisfaction of this milestone, 35% of 10,489 shares
of each of their Executive Option Grants would vest, with the balance of such 10,489 shares vesting in 36 equal monthly installments
beginning on the last day of the following month. The Board of Directors determined that this milestone was satisfied; accordingly,
each executive received the cash bonus and 3,671 shares of the Executive Options vested and became exercisable as of June
29, 2015, with the balance of 6,818 shares vesting ratably on a monthly basis beginning July 31, 2015. |
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Fundraising
Bonus Opportunities. Pursuant to the terms of the Executive Compensation Plan, Andrew and Ira Ritter were each entitled
to receive (i) a one-time cash bonus of $50,000 upon the sale of additional equity capital for cash, in one or more
closings after July 17, 2012, and/or the actual deployment of funds by a third party for a clinical trial in an aggregate
amount in excess of $2,000,000 and (ii) a one-time cash bonus of $150,000 upon the sale of additional equity capital
for cash, in one or more closings after July 17, 2012 and/or the actual deployment of funds by a third party for a clinical
trial in an aggregate amount in excess of $10,000,000 (which such bonus would be reduced by any cash bonus paid under
subsection (i)); provided, however, that no bonus under subsection (i) or (ii) would be paid at any time the Company has less
than $2,000,000 in available cash. In addition, upon the satisfaction of the milestone described in subsection (i), 35% of
6,993 shares of each of their Executive Option Grants would vest, with the balance of the 6,993 shares vesting in 36 equal
monthly installments beginning on the last day of the following month, and, upon satisfaction of the milestone described in
subsection (ii), 35% of 13,986 shares of each of their Executive Option Grants would vest, with the balance of the 13,986
shares vesting in 36 monthly installments beginning on the last day of the following month. The Board of Directors determined
that this milestone as described in subsection (ii) above was satisfied upon the closing of the Company’s initial public
offering on June 29, 2015 raising approximately $17.4 million, net of offering costs; accordingly, each executive received
a bonus of $150,000 and 4,895 shares of the Executive Options vested and became exercisable as of June 29, 2015, with the
balance of 9,091 shares vesting ratably on a monthly basis beginning July 31, 2015. |
Further,
pursuant to the terms of the Executive Compensation Plan, Andrew and Ira Ritter were each entitled to receive the following cash
and equity bonus payments in connection with the closing of an exclusive license of RP-G28 and/or any future product candidate
developed by the Company from time to time during the term of the Executive Compensation Plan by and/or any option to exclusively
license such product candidate to a third party (referred to under the Executive Compensation Plan as a “License Event”)
with a minimum upfront payment to the Company of $2,000,000:
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A
graduated cash bonus equal to (i) 5% of the Initial Period License Payment (as defined below) up to $5,000,000; (ii) 4% of
the Initial Period License Payment in excess of $5,000,000 up to $10,000,000; and (iii) 3% of the Initial Period License
Payment in excess of $10,000,000. In addition, upon the Company’s receipt of an Initial Period License Payment
of more than $2,000,000, 35% of 45,454 shares of their Executive Option Grants would vest, with the balance of the 45,454
shares vesting in 36 monthly installments beginning on the last day of the following month. |
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A
cash bonus equal to 3% of any Annual Excess Milestone Payments (as defined below); provided, however that no such bonus would
be paid at any time the Company has less than $1,000,000 in available cash. In addition, upon the Company’s receipt
of an Annual Excess Milestone Payment, 35% of 6,993 shares of their Executive Option Grants would vest and become exercisable,
with the balance of the 6,993 shares vesting in 36 monthly installments beginning on the last day of the following month.
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Notwithstanding
any of the vesting provisions described above, the total potential number of shares under the Executive Option Grant that could
vest would not exceed 48,951 and the Executive Option Grant automatically terminated for any shares for which a vesting date or
performance condition had not been met by September 25, 2015. Accordingly, as of September 30, 2015, 27,972 of the maximum 48,951
Executive Option Grants potentially issuable to Andrew and Ira Ritter had been issued to each executive subject to the vesting
conditions described above.
For
purposes of the Executive Compensation Plan, the term “Initial Period License Payment” meant the aggregate
amount in cash received by the Company (not including any amount placed in escrow or subject to earn-outs, contingencies or other
deferrals or earmarked to pay or reimburse the Company for research and development activities) in respect of the License Event
over a 24 month period beginning on the closing date of such License Event (which period is referred to therein as the “Initial
Period”). The term “Annual Excess Milestone Payments” meant the amount in cash in excess of
$2,000,000 (not including any amounts placed in escrow or subject to earn-outs, contingencies or other deferrals) that was received
by the Company in respect of any Post-Closing Milestones (as defined below) in each 12-month period beginning on the expiration
of the Initial Period. The term “Post-Closing Milestones” meant any post-closing payouts set forth in the definitive
transaction documentation executed in connection with a License Event; provided, however, that such amounts would not include
any amounts that were determined by the board of directors to comprise all or any portion of any upfront payment made in connection
with a License Event and any royalty payment based on product sales.
Under
the terms of the Executive Compensation Plan, receipt by the Company of more than one bona fide term sheet for a
proposed License Event with respect to RP-G28 would result in the payment of an additional 10% of any cash bonus earned as Clinical
Trial and Fundraising Bonus or a License Event Bonus.
Offer
Letters with Andrew Ritter and Ira Ritter
The
compensation terms outlined in the offer letters, which became effective June 29, 2015, superseded and replaced those provided
in the Executive Compensation Plan, which is described above, other than the provisions related to the bonus opportunities. The
offer letters provide that Andrew Ritter is entitled to an annual base salary of $310,000 and Ira Ritter is entitled to an annual
base salary of $295,000. In accordance with his offer letter, Andrew Ritter also became entitled to receive up to $180,000 payable
over a three year period for tuition reimbursement.
Pursuant
to their respective offer letters, Andrew Ritter and Ira Ritter each have the opportunity to earn an annual bonus based upon a
percentage of their base salary and the achievement of specific performance as determined by the Company. The initial target bonus
opportunities are 40% and 35% of the base salary for Andrew Ritter and Ira Ritter, respectively.
2008
Stock Plan
Our
2008 Stock Plan permitted us to grant non-statutory stock options, incentive stock options and restricted stock to our employees,
directors and consultants; however, incentive stock options may only be granted to our employees. The maximum aggregate number
of shares of common stock that were issuable under the 2008 Stock Plan was 2,046,158 shares, after giving effect to the 1-for-7.15
reverse stock split. Beginning June 29, 2015, no further awards may be issued under the 2008 Stock Plan.
The
2008 Stock Plan is administered by either our board of directors or a committee of our board of directors, which in either case,
we refer to as the Administrator. The Administrator has full authority and discretion to, among other things, determine the terms
and conditions of any awards granted under the 2008 Stock Plan, and construe and interpret the terms of the 2008 Stock Plan and
any awards granted thereunder.
Stock
Options. Each option will be designated in the option agreement as either an incentive stock option or a nonstatutory stock
option. Notwithstanding such designation, however, to the extent that the aggregate Fair Market Value (as defined in the 2008
Stock Plan) of the shares with respect to which an incentive stock option is exercisable for the first time by the optionee during
any calendar year (under all plans of the Company and any parent or subsidiary) exceeds $100,000, such options will be treated
as nonstatutory stock options. The term of any stock option awarded under the 2008 Stock Plan will not exceed 10 years from the
date of grant. In the case of an incentive stock option granted to a person who, at the time the stock option is granted, owns
stock representing more than 10% of the voting power of all classes of our stock or any parent or subsidiary, who we refer to
as a 10% Holder, the term of the option will be five years from the date of grant or such shorter period as may be provided in
the option agreement. The per share exercise price for shares to be issued upon exercise of an option will be such price as is
determined by the Administrator, but will be (i) in the case of an incentive stock option, (A) granted to an employee who, at
the time of grant of such option, is a 10% Holder, no less than 110% of the Fair Market Value per share on the date of grant;
or (B) granted to any other employee, no less than 100% of the Fair Market Value per share on the date of grant; and (ii) in the
case of a nonstatutory stock option, no less than 100% of the Fair Market Value per share on the date of grant. The consideration
to be paid for the shares to be issued upon exercise of a stock option, including the method of payment, will be determined by
the Administrator (and, in the case of an incentive stock option, will be determined at the time of grant). Such consideration
may consist of, without limitation, (1) cash, (2) check, (3) promissory note, (4) other shares (provided that such shares have
a Fair Market Value on the date of surrender equal to the aggregate exercise price of the shares as to which such option may be
exercised and provided that accepting such shares, in the sole discretion of the Administrator, will not result in any adverse
accounting consequences to the Company), (5) consideration received by us under a cashless exercise program we have implemented
in connection with the 2008 Stock Plan, or (6) such other consideration and method of payment for the issuance of shares to the
extent permitted by applicable laws, or (7) any combination of the foregoing methods of payment.
Restricted
Stock. Restricted stock may be issued either alone, in addition to, or in tandem with other awards granted under the 2008
Stock Plan and/or cash awards made outside of the 2008 Stock Plan, at a purchase price determined by the Administrator. Any restricted
stock granted under the 2008 Stock Plan will be subject to the terms and conditions of a restricted stock purchase agreement,
which, unless the Administrator determines otherwise, will grant us a repurchase option according to terms the Administrator determines.
The term of each restricted stock award will be no more than 10 years from the date of grant.
Under
the 2008 Stock Plan, if an optionee ceases to be an employee, director, consultant, such optionee may exercise his or her option
within 30 days of termination, or such longer period of time as specified in the option agreement, to the extent that the option
is vested on the date of termination (but in no event later than the expiration of the term of the option as set forth in the
option agreement). Unless the Administrator provides otherwise, if, on the date of termination, the optionee is not vested as
to his or her entire option, the shares covered by the unvested portion of the option will revert to the 2008 Stock Plan. If,
after termination, the optionee does not exercise his or her option within the time specified by the Administrator, the option
will terminate, and the shares covered by such option will revert to the 2008 Stock Plan. Unless the Administrator provides otherwise,
or except as otherwise required by applicable laws, vesting of options granted to employees, officers and directors will be suspended
during any unpaid leave of absence. For purposes of incentive stock options, no such leave may exceed 90 days, unless reemployment
upon expiration of such leave is guaranteed by statute or contract. If reemployment upon expiration of a leave of absence approved
by us is not so guaranteed, then six months following the first day of such leave, any incentive stock option held by the optionee
will be treated for tax purposes as a nonstatutory stock option.
If
an optionee ceases to be an employee, director, consultant as a result of the optionee’s Disability (as defined in the 2008
Stock Plan), the optionee may exercise his or her option within six months of termination, or such longer period of time as specified
in the option agreement, to the extent the option is vested on the date of termination (but in no event later than the expiration
of the term of the option as set forth in the option agreement). Unless the Administrator provides otherwise, if, on the date
of termination, the optionee is not vested as to his or her entire option, the shares covered by the unvested portion of the option
will revert to the 2008 Stock Plan. If, after termination, the optionee does not exercise his or her option within the time specified,
the option will terminate, and the shares covered by such option will revert to the 2008 Stock Plan.
If
an optionee dies while an employee, director, consultant, the option may be exercised within six months following the optionee’s
death, or such longer period of time as specified in the option agreement, to the extent the option is vested on the date of termination
(but in no event later than the expiration of the term of the option as set forth in the option agreement) by the optionee’s
designated beneficiary; provided such beneficiary has been designated prior to optionee’s death in a form acceptable to
the Administrator. If no such beneficiary has been designated by the optionee, then such option may be exercised by the personal
representative of the optionee’s estate or by the person(s) to whom the option is transferred pursuant to the optionee’s
will or in accordance with the laws of descent and distribution. If, at the time of death, the optionee is not vested as to his
or her entire option, the shares covered by the unvested portion of the option will revert to the 2008 Stock Plan. If the option
is not so exercised within the time specified, the option will terminate, and the shares covered by such option will revert to
the 2008 Stock Plan.
If
an option or restricted stock purchase right expires or becomes unexercisable without having been exercised in full, or is surrendered
pursuant to an exchange program, the unpurchased shares that were subject to such award will become available for future grant
or sale under the 2008 Stock Plan (unless the 2008 Stock Plan has terminated). However, shares that have actually been issued
under the 2008 Stock Plan, upon exercise of either an option or restricted stock purchase right, will not be returned to the 2008
Stock Plan and will not become available for future distribution under the 2008 Stock Plan, except that if unvested shares of
restricted stock are repurchased by us at their original purchase price, such shares will become available for future grant under
the 2008 Stock Plan.
Unless
determined otherwise by the Administrator, options and restricted stock purchase rights may not be sold, pledged, assigned, hypothecated,
transferred or disposed of in any manner, and may be exercised only by the optionee during such person’s lifetime.
In
the event that any dividend or other distribution (whether in the form of cash, shares, other securities, or other property),
recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase
or exchange of our shares or other securities, or other change in our corporate structure affecting the shares occurs, the Administrator,
in order to prevent diminution or enlargement of the benefits or potential benefits intended to be made available under the 2008
Stock Plan, will adjust the number of and class of shares that may be delivered under the 2008 Stock Plan and/or the number, class
and price of shares covered by each outstanding option or stock purchase right; provided, however, that the Administrator will
make such adjustments to the extent required by Section 25102(o) of the California Corporations Code.
The
board of directors may at any time amend, alter, suspend or terminate the 2008 Stock Plan, but must obtain stockholder approval
of any amendment to the extent necessary and desirable to comply with applicable laws. No amendment, alteration, suspension or
termination of the 2008 Stock Plan may impair the rights of any optionee, unless otherwise mutually agreed in writing by the optionee
and the Administrator. The 2008 Stock Plan will continue in effect for a term of ten years from the later of (a) the effective
date of the Plan or (b) the earlier of the most recent board or stockholder approval of an increase in the number of shares reserved
for issuance under the 2008 Stock Plan.
2009
Stock Plan
Our
2009 Stock Plan permitted us to grant non-statutory stock options, incentive stock options and stock purchase rights to our employees,
outside directors and consultants; however, incentive stock options could only be granted to our employees. The maximum aggregate
number of shares of common stock that were issuable under the 2009 Stock Plan was 69,930 shares, after giving effect to the 1-for-7.15
reverse stock split. Beginning June 29, 2015, no further awards may be issued under the 2009 Stock Plan.
The
2009 Stock Plan is administered by either our board of directors or a committee of our board of directors, which in either case,
we refer to as the Administrator. The Administrator has full authority and discretion to, among other things, determine the terms
and conditions of any awards granted under the 2009 Stock Plan, and construe and interpret the terms of the 2009 Stock Plan and
any awards granted thereunder.
Stock
Options. Each option will be designated in the option agreement as either an incentive stock option or a nonstatutory stock
option. Notwithstanding such designation, however, to the extent that the aggregate Fair Market Value (as defined in the 2009
Stock Plan) of the shares with respect to which an incentive stock option is exercisable for the first time by the optionee during
any calendar year (under all plans of the Company and any parent or subsidiary) exceeds $100,000, such options will be treated
as nonstatutory stock options. The term of any stock option awarded under the 2009 Stock Plan shall not exceed 10 years from the
date of grant. In the case of an incentive stock option granted to a person who, at the time the stock option is granted, owns
stock representing more than 10% of the voting power of all classes of our stock or any parent or subsidiary of, who we refer
to as a 10% Holder, the term of the option will be five years from the date of grant or such shorter period as may be provided
in the option agreement. The per share exercise price for shares to be issued upon exercise of an option will be such price as
is determined by the Administrator, but will be (i) in the case of an incentive stock option, (A) granted to an employee who,
at the time of grant of such option, is a 10% Holder, no less than 110% of the Fair Market Value per share on the date of grant;
or (B) granted to any other employee, no less than 100% of the Fair Market Value per share on the date of grant; and (ii) in the
case of a nonstatutory stock option, no less than 100% of the Fair Market Value per share on the date of grant. The consideration
to be paid for the shares to be issued upon exercise of a stock option, including the method of payment, will be determined by
the Administrator (and, in the case of an incentive stock option, will be determined at the time of grant). Such consideration
may consist of, without limitation, (1) cash, (2) check, (3) promissory note, (4) other shares (provided shares acquired directly
from us (x) have been owned by the optionee for more than six months of the date of surrender and (y) have a Fair Market Value
of the date of surrender equal to the aggregate exercise price of the shares as to which such option may be exercised), (5) consideration
received by us under a cashless exercise program we have implemented in connection with the 2009 Stock Plan, or (6) any combination
of the foregoing methods of payment.
Stock
Purchase Rights. Stock Purchase Rights may be issued either alone, in addition to, or in tandem with other awards granted
under the 2009 Stock Plan and/or cash awards made outside of the 2009 Stock Plan, and will entitle the recipient to purchase shares
of our common stock at a purchase price determined by the Administrator. Any stock purchase rights granted under the 2009 Stock
Plan will be subject to the terms and conditions of a restricted stock purchase agreement, which, unless the Administrator determines
otherwise, will grant us a repurchase option exercisable within 90 days of the voluntary or involuntary termination of the purchaser’s
service with us for any reason (including death or disability) at the original price paid by the purchase, which may be paid by
us by cancellation of any indebtedness of the purchaser to us, and which right will lapse at such rate as the Administrator may
determine.
Under
the 2009 Stock Plan, if an optionee ceases to be an employee, director, consultant (or other permitted recipient under Rule 701
under the Securities Act), such optionee may exercise his or her option within 30 days of termination, or such longer period of
time as specified in the option agreement, to the extent that the option is vested on the date of termination (but in no event
later than the expiration of the term of the option as set forth in the option agreement, and in the case of an incentive stock
option, in no event later than the earlier of three months after the date of termination and the expiration of the term of the
option as set forth in the option agreement). If, on the date of termination, the optionee is not vested as to his or her entire
option, the shares covered by the unvested portion of the option will revert to the 2009 Stock Plan. If, after termination, the
optionee does not exercise his or her option within the time specified by the Administrator, the option will terminate, and the
shares covered by such option will revert to the 2009 Stock Plan. Unless the Administrator provides otherwise, vesting of options
granted to employees, officers and directors will be suspended during any unpaid leave of absence. For purposes of incentive stock
options, no such leave may exceed 90 days, unless reemployment upon expiration of such leave is guaranteed by statute or contract.
If reemployment upon expiration of a leave of absence approved by us is not so guaranteed, then following the 91st
day of such leave, any incentive stock option held by the optionee will cease to be treated as an incentive stock option and will
instead be treated for tax purposes as a nonstatutory stock option.
If
an optionee ceases to be an employee, director, consultant (or other permitted recipient under Rule 701 under the Securities Act),
as a result of the optionee’s Disability (as defined in the 2009 Stock Plan), the optionee may exercise his or her option
within six months of termination, or such longer period of time as specified in the option agreement, to the extent the option
is vested on the date of termination (but in no event later than the expiration of the term of the option as set forth in the
option agreement, and in the case of an incentive stock option, in no event later than the earlier of three months after the date
of termination and the expiration of the term of the option as set forth in the option agreement). If, on the date of termination,
the optionee is not vested as to his or her entire option, the shares covered by the unvested portion of the option will revert
to the 2009 Stock Plan. If, after termination, the optionee does not exercise his or her option within the time specified by the
Administrator, the option will terminate, and the shares covered by such option will revert to the 2009 Stock Plan.
If
an optionee dies while an employee, director, consultant (or other permitted recipient under Rule 701 under the Securities Act),
the option may be exercised within six months following the optionee’s death, or such longer period of time as specified
in the option agreement, to the extent the option is vested on the date of termination (but in no event later than the expiration
of the term of the option as set forth in the option agreement) by the optionee’s designated beneficiary; provided such
beneficiary has been designated prior to optionee’s death in a form acceptable to the Administrator. If no such beneficiary
has been designated by the optionee, then such option may be exercised by the personal representative of the optionee’s
estate or by the person(s) to whom the option is transferred pursuant to the optionee’s will or in accordance with the laws
of descent and distribution. If, at the time of death, the optionee is not vested as to his or her entire option, the shares covered
by the unvested portion of the option will revert to the 2009 Stock Plan. If the option is not so exercised within the time specified
above, the option will terminate, and the shares covered by such option will revert to the 2009 Stock Plan.
If
an option or stock purchase right expires or becomes unexercisable without having been exercised in full, the unpurchased shares
that were subject to such award will become available for future grant or sale under the 2009 Stock Plan (unless the 2009 Stock
Plan has terminated). However, shares that have actually been issued under the 2009 Stock Plan, upon exercise of either an option
or stock purchase right, will not be returned to the 2009 Stock Plan and will not become available for future distribution under
the 2009 Stock Plan, except that if unvested shares of restricted stock are repurchased by us at their original purchase price,
such shares will become available for future grant under the 2009 Stock Plan.
Unless
determined otherwise by the Administrator, options and stock purchase rights may not be sold, pledged, assigned, hypothecated,
transferred or disposed of in any manner, and may be exercised only by the optionee during such person’s lifetime.
In
the event that any dividend or other distribution (whether in the form of cash, shares, other securities, or other property),
recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase
or exchange of our shares or other securities, or other change in our corporate structure affecting the shares occurs, the Administrator,
in order to prevent diminution or enlargement of the benefits or potential benefits intended to be made available under the 2009
Stock Plan, may (in its sole discretion) adjust the number of and class of shares that may be delivered under the 2009 Stock Plan
and/or the number, class and price of shares covered by each outstanding option or stock purchase right; provided, however, that
the Administrator will make such adjustments to the extent required by Section 25102(o) of the California Corporations Code.
The
board of directors may at any time amend, alter, suspend or terminate the 2009 Stock Plan, but must obtain stockholder approval
of any amendment to the extent necessary and desirable to comply with applicable laws. The 2009 Stock Plan will also be subject
to approval by our stockholders prior to the later of (i) 12 months after the 2009 Stock Plan is adopted or (ii) the date
of first grant of an option or stock purchase right to an employee, director or consultant (or other permitted recipient under
Rule 701 under the Securities Act) in California. No amendment, alteration, suspension or termination of the 2009 Stock Plan may
impair the rights of any optionee, unless otherwise mutually agreed in writing by the optionee and the Administrator.
2015
Equity Incentive Plan
On
June 17, 2015, we adopted a new equity incentive plan. The following description of the 2015 Equity Incentive Plan, or the 2015
Plan, is qualified in its entirety by the full text of the plan,
which is incorporated by reference as an exhibit to the registration statement of which this prospectus is a part.
Purpose.
The purposes of the 2015 Plan are to optimize the profitability and growth of the Company through long-term incentives that
are consistent with the Company’s objectives and that link the interests of award recipients, or Grantees, to those of the
Company’s stockholders; to give award recipients an incentive for excellence in individual performance; to promote teamwork
among Grantees; and to give the Company flexibility in attracting and retaining key employees, directors and consultants.
Eligibility.
Selected employees, officers and directors of the Company or any subsidiary, and consultants, advisors and independent service
providers to the Company and any subsidiary who qualify as a “consultant” under the applicable rules of the SEC for
registration of shares on a Form S-8 registration statement, are eligible to receive awards under the 2015 Plan. The plan administrator
may also grant awards to individuals in connection with hiring, retention or otherwise before the date the individual first performs
services for the Company or any subsidiary; provided, however, that those awards will not become vested or exercisable before
the date the individual first performs services for the Company or any subsidiary.
Shares
subject to the 2015 Plan. The number of shares of common stock that we may issue pursuant to awards under the 2015 Plan is
(i) 328,289 plus (ii) any shares which are subject to awards under the 2008 Plan and/or the 2009 Plan, or the Prior Plans, which
after the effective date of the 2015 Plan are forfeited or lapse unexercised or are settled in cash and are not issued under the
Prior Plans. No more than 328,289 shares of common stock may be issued pursuant to incentive stock options intended to qualify
under section 422 of the Internal Revenue Code, or the Code. After the effective date of the 2015 Plan, no awards may be granted
under any Prior Plan; however, any awards granted under any Prior Plan that are outstanding as of the effective date of the 2015
Plan will continue to be subject to the terms and conditions of such Prior Plan.
The
maximum number of shares of common stock subject to awards of any combination that may be granted under the 2015 Plan during any
calendar year to any one individual will be limited to 65,657 shares; provided, however, that the foregoing limitation will not
apply until the earliest of (a) the first material modification of the 2015 Plan (including any increase in the number
of shares reserved for issuance under the 2015 Plan); (b) the issuance of all of the shares reserved for issuance under the 2015
Plan; (c) the first meeting of stockholders at which members of the board of directors are elected that occurs after the close
of the third calendar year following the calendar year in which occurred the first registration of an equity security of the Company
under Section 12 of the Exchange Act; or (d) such other date required by section 162(m) of the Code.
These
limits will be appropriately adjusted to reflect any stock dividend, stock split, combination or exchange of shares, merger, consolidation
or other distribution and/or similar transactions. To the extent that (i) an award terminates, expires, lapses or is forfeited
for any reason, (ii) any award is settled in cash (in whole or in part) without the delivery of shares to the Grantee, or (iii)
any shares subject to an award under any Prior Plan terminate, expire, lapse or are forfeited for any reason or an award under
any Prior Plan is settled for cash (in whole or in part), then any shares subject to the award, to the extent of such termination,
expiration, lapse, forfeiture or cash settlement, will again be available for the grant of an award pursuant to the 2015 Plan.
Any shares tendered or withheld to satisfy the grant or exercise prior or tax withholding obligation pursuant to any award will
again be available for the grant of an award pursuant to the 2015 Plan.
Administration.
The 2015 Plan will be administered by a committee or subcommittee of the board of directors as the board of directors may
appoint from time to time, or by our full board of directors if no committee is designated or for other specific purposes. The
plan administrator has the full authority and discretion to administer the 2015 Plan and to take any action that is necessary
or advisable in connection with the administration of the 2015 Plan, including without limitation the authority and discretion
to interpret and administer the plan and any award agreement relating to the plan or any award made thereunder, the authority
to designate Grantees to receive awards under the plan and to determine the type or types of awards to be granted to such Grantees,
the authority to determine the terms and conditions of awards granted under the plan, and the authority to determine whether,
to what extent, and pursuant to what circumstances and award may be settled in, or the exercise price of an award may be paid
in, cash, shares, other awards, or other property, or an award may be canceled, forfeited or surrendered. The plan administrator’s
determinations will be final and conclusive. The plan administrator may delegate certain of its authority to others as specified
in the plan.
Types
of awards. The 2015 Plan provides for grants of stock options (including incentive stock options qualifying under section
422 of the Code and nonstatutory stock options), restricted stock awards, stock appreciation rights, restricted stock units, performance
awards, other stock-based awards or any combination of the foregoing. No awards have been granted under the 2015 Plan as of the
date of this prospectus. The benefits or amounts that will be allocated to any participant or group of participants are indeterminable
at this time because participation and the types of awards (including options) available under the 2015 Plan are subject to the
discretion of the plan administrator.
Stock
options. The 2015 Plan allows the plan administrator to grant incentive stock options, as that term is defined in section
422 of the Code, or nonqualified stock options. No incentive stock option award may be granted to any person who is not an employee
of the Company or any subsidiary. Options must have an exercise price at least equal to the fair market value of the underlying
shares on the date of grant. In addition, in the case of incentive stock options granted to a greater than 10% stockholder of
the Company, such exercise price may not be less than 110% of the fair market value of the underlying shares on the date of grant.
The option holder may pay the exercise price in cash or by check, by tendering shares of common stock (including shares issuable
in settlement of the award), payment through a broker or by any other means that the plan administrator approves. Options granted
under the 2015 Plan will have a term of no more than 10 years, or five years in the case of incentive stock options granted to
a greater than 10% stockholder of the Company; however, the options will expire earlier if the option holder’s service relationship
with us terminates or as otherwise provided in an award agreement.
Restricted
stock awards. The 2015 Plan allows the plan administrator to grant restricted stock awards, which issue to the holder a certain
number of shares of common stock that are subject to restrictions or conditions as the plan administrator deems appropriate, such
as time-based or performance-based criteria, and which become vested upon the lapse or satisfaction of such conditions. The plan
administrator may apply limitations to any restricted stock award and establish the purchase price (or provide for no purchase
price), provided that if a purchase price is established, it may not be less than par value of the shares to be purchased.
Stock
appreciation rights. The 2015 Plan allows the plan administrator to grant awards of stock appreciation rights, which entitle
the holder to receive a payment in cash, in shares of common stock, or in a combination of both, having an aggregate value equal
to the spread on the date of exercise between the fair market value of the underlying shares on that date and the base price of
the shares specified in the grant agreement, multiplied by the number of shares specified in the award being exercised and as
otherwise provided in an award agreement. Stock appreciation rights may not have a base price of less than 100% of the fair market
value of the underlying shares on the date of grant.
Restricted
stock units. The 2015 Plan allows the plan administrator to grant awards of restricted stock units, or RSUs, which entitle
the holder to a number of shares of common stock, a cash payment or some combination thereof, upon satisfaction of vesting and
other criteria for issuance or upon such later date as specified in the award agreement, as established by the plan administrator
in the award agreement.
Other
stock-based awards. The 2015 Plan allows the plan administrator to grant other stock-based stock awards to eligible participants,
including dividend equivalent rights, stock payments and/or deferred stock. A dividend equivalent may be granted alone or in conjunction
with another type of award, and generally provides for payment, in cash, common stock or some combination thereof, of an amount
equal to the dividends that would have been payable with respect to a specified number of underlying shares. A stock payment is
an award to a Grantee, only upon satisfaction of performance-based criteria or other criteria specified by the plan administrator,
of a specified number of shares of common stock, or an option to purchase common stock, which may be (but is not required to be)
in lieu of base salary, bonus, fees or other cash consideration to the Grantee. A deferred stock award is a grant to a Grantee,
only upon satisfaction of performance-based criteria or other criteria specified by the plan administrator, of a specified number
of shares of common stock.
Performance
awards. The 2015 Plan allows the plan administrator to grant performance awards which become payable in common stock, in cash
or in a combination of common stock and cash, on account of attainment of one or more performance goals established by the plan
administrator on one or more specified dates or over a specified period or periods. The plan administrator may establish performance
goals relating to any of the following: (i) gross or net earnings (either before or after one or more of the following: interest,
taxes, depreciation and amortization); (ii) gross or net sales or revenue; (iii) gross or net income or adjusted income (either
before or after taxes); (iv) operating earnings or profit; (v) cash flow (including, but not limited to, operating cash flow and
free cash flow); (vi) return on assets; (vii) return on capital; (viii) return on stockholders’ equity; (ix) return on sales;
(x) gross or net profit or operating margin; (xi) costs; (xii) funds from operations; (xiii) expenses; (xiv) working capital;
(xv) earnings per share or adjusted earnings per share; (xvi) price per share of common stock; (xvii) regulatory body approval
for commercialization of a product; (xviii) implementation or completion of critical projects; (xix) market share; or (xx) total
stockholder return; any of which may be measured either in absolute terms or as compared to any incremental increase or decrease
or as compared to results of a peer group or to market performance indicators or indices.
The
plan administrator may, in its sole discretion, provide that one or more objectively determinable adjustments will be made to
one or more of the performance goals described above, such as adjustments to account for changes in the Company’s or segment’s
business (e.g., restructuring, acquisition or disposal or discontinuance of a business segment), accounting or financial reporting
(e.g., change in accounting principles, significant income or expense or amortization of assets) or for other unusual or non-recurring
events, all as further detailed in the 2015 Plan. For all awards intended to qualify as performance-based compensation, such determinations
shall be made within the time periods prescribed by, and otherwise in compliance with, section 162(m) of the Code.
Amendment
and termination. The 2015 Plan became effective June 17, 2015. Awards may be granted prior to stockholder approval, provided
that awards may not be exercisable, will not vest, restrictions thereupon will not lapse, nor will shares be issued pursuant to
such awards, prior to approval by the stockholders. No award will be granted under the 2015 Plan after the tenth anniversary of
the effective date of the plan. Subject to applicable laws and exchange limitations, our board of directors or the plan administrator
may terminate, amend or modify the 2015 Plan, or any portion thereof, at any time. Stockholder approval will be required to (i)
increase the limits imposed on the maximum number of shares which may be issued under the 2015 Plan or as incentive stock options
(other than an appropriate adjustment due to stock dividend, stock split, combination or exchange of shares, merger, consolidation
or similar circumstance), (ii) reduce the price per share of any outstanding option or stock appreciation right or cancel any
such award in exchange for cash when the exercise price per share exceeds the fair market value of the underlying shares, or (iii)
materially change the class of persons who are eligible to participate in the 2015 Plan; provided, however, that no amendment,
suspension or termination of the 2015 Plan may, without the consent of the Grantee, materially impair any rights or obligations
under any award granted or awarded thereunder, unless the award itself otherwise expressly so provides.
Outstanding
Equity Awards at 2015 Fiscal Year-End
The
following table presents the outstanding equity awards held by each of the named executive officers as of December 31, 2015.
Name |
|
Number of
Securities
Underlying
Unexercised
Options
Exercisable |
|
|
Number of
Securities
Underlying
Unexercised
Options
Unexercisable |
|
|
Option
Exercise
Price
($) |
|
Option
Expiration
Date |
Michael
D. Step |
|
|
22,893 |
(1) |
|
|
3,270 |
(1) |
|
$ |
1.14 |
|
8/16/2022 |
|
|
|
646,537 |
(2) |
|
|
— |
|
|
$ |
5.86 |
|
12/2/2024 |
|
|
|
73,377 |
(3) |
|
|
— |
|
|
$ |
5.86 |
|
12/2/2024 |
|
|
|
163,799 |
(4) |
|
|
— |
|
|
$ |
5.86 |
|
12/2/2024 |
Andrew J. Ritter
|
|
|
14,461 |
(5) |
|
|
13,511 |
(5) |
|
$ |
1.27 |
|
9/25/2023 |
|
|
|
20,979 |
(6) |
|
|
— |
|
|
$ |
5.86 |
|
12/2/2024 |
|
|
|
135,136 |
|
|
|
297,299 |
(7) |
|
|
|
(7) |
12/2/2024 |
Ira E. Ritter
|
|
|
14,461 |
(8) |
|
|
13,511 |
(8) |
|
$ |
1.27 |
|
9/25/2023 |
|
|
|
20,979 |
(9) |
|
|
— |
|
|
$ |
5.86 |
|
12/2/2024 |
|
|
|
135,136 |
|
|
|
297,299 |
(10) |
|
|
|
(10) |
12/2/2024 |
(1) |
This
option was granted to Michael Step on August 16, 2012 and vests as follows: 25% of the shares became exercisable on June 25,
2013 and the remaining 75% of the shares are exercisable in 36 equal monthly installments beginning on the last day of
the first full month thereafter. |
|
|
(2) |
This
option was granted to Michael Step on December 2, 2014 and was immediately exercisable in full as of the date of grant. Of
the shares subject to this option, 592,659 shares are subject to a right of repurchase in favor of us at a price of $5.86
per share, which right expires ratably over 44 months commencing January 1, 2015 and in full upon a change of control or upon
Mr. Step’s employment termination by us without Cause, subject to his continued employment with us (as described in
the stock option award agreement). |
|
|
(3) |
This
option was granted to Michael Step on December 2, 2014 and was immediately exercisable in full as of the date of grant. Of
the shares subject to this option, 67,262 shares are subject to a right of repurchase in favor of us at a price of $5.86
per share, which rights expires ratably over 44 months commencing January 1, 2015 and in full upon a change of control or
upon Mr. Step’s employment termination by us without Cause, subject to his continued employment with us (as described
in the stock option award agreement). |
|
|
(4) |
This
option was granted to Michael Step on December 2, 2014. The total number of shares issued under this option equaled the number
of shares of common stock, together with the 646,537 shares subject to the option granted to Mr. Step on December 2, 2014,
representing in the aggregate 7.5% of the shares of common stock deemed to be outstanding on a fully-diluted basis as of the
date that we raised in the aggregate a minimum of $15,000,000 in one or more private and/or public offerings, or a
Qualified Financing, after giving effect to (i) the issuance of the shares issued in the Qualified Financing, (ii) the issuance
of this option and (iii) any adjustments. See “Narrative to Summary Compensation Table— Letter Agreement with
Michael D. Step” for additional details regarding this stock option, which became exercisable for 163,799 shares of
common stock upon the closing of our initial public offering. |
(5) |
This
option was granted to Andrew Ritter on September 25, 2013 for an aggregate of up to 48,951 shares, subject to the
achievement of certain milestones. The option included 2,360 shares that vested and became exercisable as of the date of
grant (with a balance of 1,137 shares vesting ratably on a monthly basis from September 30, 2013 over 36 months)
attributable to the FDA Meeting Bonus Opportunities milestone. An additional 3,671 shares vested and became exercisable
as of June 29, 2015 (with a balance of 6,818 shares vesting ratably on a monthly basis from July 31, 2015 over 36 months)
attributable to the Clinical Trial Funding Commitment Bonus Opportunity milestone. An additional 4,895 shares vested and
became exercisable as of June 29, 2015 (with a balance of 9,091 shares vesting ratably on a monthly basis beginning July
31, 2015 over 36 months) attributable to the Fundraising Bonus Opportunities milestone. The option for the remaining
balance of the 20,979 shares expired unvested on September 30, 2015. |
|
|
(6) |
This
option was granted to Andrew Ritter on December 2, 2014 and was vested in full and exercisable, in whole or in part, as of
the date of grant. |
|
|
(7) |
This
option was granted to Andrew Ritter on December 2, 2014 and vests as follows: 25% of the shares vest on September 1, 2015
and the remaining 75% of the shares will vest in 36 equal monthly installments beginning on the last day of the first full
month thereafter, subject to his continued employment with us. The exercise price for this option is as follows: (i) $5.86
for the first 152,347 shares; (ii) $9.30 for the next 140,044 shares; and (iii) $13.23 for the remaining 140,043 shares. |
|
|
(8) |
This
option was granted to Ira Ritter on September 25, 2013 and is subject to the same vesting schedule as the option granted to
Andrew Ritter on this date as reflected in footnote (5) above. |
|
|
(9) |
This
option was granted to Ira Ritter on December 2, 2014 and was vested in full and exercisable, in whole or in part, as of the
date of grant. |
|
|
(10) |
This
option was granted to Ira Ritter on December 2, 2014 and vests as follows: 25% of the shares vest on September 1, 2015 and
the remaining 75% of the shares will vest in 36 equal monthly installments beginning on the last day of the first full month
thereafter, subject to his continued employment with us. The exercise price for this option is as follows: (i) $5.86 for the
first 152,347 shares; (ii) $9.29 for the next 140,044 shares; and (iii) $13.23 for the remaining 140,043 shares. |
Payments
Due Upon Termination of Employment or a Change in Control
Executive
Severance & Change in Control Agreements
We
have entered into Executive Severance & Change in Control Agreements, or the Severance Agreements, with each of our executive
officers. The Severance Agreements provide that if we terminate the executive’s employment without Cause, or the executive
terminates his employment for Good Reason, the executive will be entitled to: (i) the Accrued Obligations; (ii) an amount equal
to twelve (12) months of base salary, as in effect immediately prior to the termination date; (iii) medical, dental benefits provided
by the Company to the executive and his spouse and dependents at least equal to the levels of benefits provided to other similarly
situated active employees of the Company and its subsidiaries until the earlier of (a) the twelve (12) month anniversary of the
date of termination or (b) the date that the executive becomes covered under a subsequent employer’s medical and dental
plans; and (iv) acceleration of vesting of all equity and equity-based awards.
Pursuant
to the terms of the Severance Agreements, in the event that within one (1) month prior to or the twelve (12) months following
a Change in Control, the Company terminates the executive’s employment without Cause, or the executive terminates his employment
for Good Reason, then, in lieu of the payments and benefits otherwise due to the executive in the preceding paragraph, the executive
will be entitled to: (i) the Accrued Obligations; (ii) an amount equal to the sum of twelve (12) months of base salary, as in
effect on the date of termination or the date of the Change in Control, whichever is greater; (iii) medical, dental benefits provided
by the Company to the executive and his spouse and dependents at least equal to the level of benefits provided to other similarly
situated active employees of the Company and its subsidiaries until the earlier of (a) the twelve (12) month anniversary of the
date of termination or (b) the date that the executive becomes covered under a subsequent employer’s medical and dental
plans; and (iv) acceleration of vesting of all equity and equity-based awards.
In
the event the executive’s employment is terminated by him without Good Reason, by the Company for Cause or due to the executive’s
death or disability, the executive and/or his estate or beneficiaries will be solely entitled to the Accrued Obligations.
The
executive’s entitlement to the payments (other than the Accrued Obligations) and benefits described above is expressly contingent
upon him providing the Company with a signed release satisfactory to the Company.
For
purposes of the Severance Agreements:
“Accrued
Obligations” means (i) earned but unpaid base salary through the date of termination; (ii) payment of any annual, long-term,
or other incentive award which relates to a completed fiscal year or performance period, as applicable, and is payable (but not
yet paid) on or before the date of termination; (iii) a lump-sum payment in respect of accrued but unused vacation days at the
executive’s per-business-day base salary rate in effect as of the date of termination; and (iv) any unpaid expense or reimbursements
due pursuant to Company expense reimbursement policy.
“Cause”
means a finding by the Company that the executive has (i) been convicted of a felony or crime involving moral turpitude; (ii)
disclosed trade secrets or confidential information of the Company (or any parent or subsidiary) to persons not entitled to receive
such information; (iii) engaged in conduct in connection with the executive’s employment or service to the Company (or any
parent or subsidiary), that has, or could reasonably be expected to result in, material injury to the business or reputation of
the Company (or any parent or subsidiary), including, without limitation, act(s) of fraud, embezzlement, misappropriation and
breach of fiduciary duty; (iv) violated the operating and ethics policies of the Company (or any parent or subsidiary) in any
material way, including, but not limited to those relating to sexual harassment and the disclosure or misuse of confidential information;
(v) engaged in willful and continued negligence in the performance of the duties assigned to the executive by the Company, after
the executive has received notice of and failed to cure such negligence; or (vi) breached any material provision of any agreement
between the executive and the Company (or any parent or subsidiary), including, without limitation, any confidentiality agreement.
“Change
in Control” means the occurrence of any of the following events:
|
(i) |
Any
“person” (as such term is used in sections 13(d) and 14(d) of the Exchange Act) becomes a “beneficial owner”
(as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing more
than 50% of the voting power of the then outstanding securities of the Company; provided that a Change of Control will not
be deemed to occur as a result of a change of ownership resulting from the death of a shareholder, and a Change of Control
will not be deemed to occur as a result of a transaction in which the Company becomes a subsidiary of another corporation
and in which the shareholders of the Company, immediately prior to the transaction, will beneficially own, immediately after
the transaction, shares entitling such shareholders to more than 50% of all votes to which all shareholders of the parent
corporation would be entitled in the election of directors (without consideration of the rights of any class of stock to elect
directors by a separate class vote); |
|
|
|
|
(ii) |
A
change in the effective control of the Company which occurs on the date that a majority of members of the board of directors
is replaced during any twelve (12) month period by Directors whose appointment or election is not endorsed by a majority of
the members of the board of directors prior to the date of the appointment or election; or |
|
|
|
|
(iii) |
The
consummation of (A) a merger or consolidation of the Company with another corporation where the shareholders of the
Company, immediately prior to the merger or consolidation, will not beneficially own, immediately after the merger or consolidation,
shares entitling such shareholders to more than 50% of all votes to which all shareholders of the surviving corporation would
be entitled in the election of directors (without consideration of the rights of any class of stock to elect directors by
a separate class vote); (B) a sale or other disposition of all or substantially all of the assets of the Company; or (C) a
liquidation or dissolution of the Company. |
“Good
Reason” means, without the executive’s express written consent, the occurrence of any one or more of the following:
(i) a substantial and material diminution in the executive’s duties or responsibilities; (ii) a material reduction in the
executive’s Base Salary; or (iii) the relocation of the executive’s principal place of employment to a location more
than 50 miles from the executive’ principal work location to a location that is more than 50 miles from the prior location.
Notwithstanding the foregoing, a relocation of Mr. Step’s principal place of employment to a location closer to Mr. Step’s
principal residence in San Diego, California shall not constitute “Good Reason.” A termination of employment by the
executive for Good Reason will be effectuated by giving the Company written notice, or Notice of Termination for Good Reason,
not later than 90 days following the occurrence of the circumstance that constitutes Good Reason, setting forth in reasonable
detail the specific conduct of the Company that constitutes Good Reason and the specific provision(s) of this Agreement on which
the executive relied. The Company will be entitled, during the 30-day period following receipt of a Notice of Termination for
Good Reason, to cure the circumstances that gave rise to Good Reason, provided that the Company shall be entitled to waive its
right to cure or reduce the cure period by delivery of written notice to that effect to the executive (such 30-day or shorter
period, the “Cure Period”). If, during the Cure Period, such circumstance is remedied, the executive will not be permitted
to terminate his employment for Good Reason as a result of such circumstance. If, at the end of the Cure Period, the circumstance
that constitutes Good Reason has not been remedied, the executive will terminate employment for Good Reason on the date of expiration
of the Cure Period.
2008
Stock Plan
The
2008 Stock Plan provides that in the event of a merger or a Change in Control (as defined below) occurs, each outstanding award
will be treated as the administrator determines, including, without limitation, that each award be assumed or an equivalent award
be substituted by the successor corporation or a parent or subsidiary of the successor corporation. In the event of a Change in
Control in which the successor corporation does not assume or substitute for the award, awards outstanding under the 2008 Plan
will become fully vested and exercisable, including shares as to which such award would not otherwise be vested or exercisable,
and all restrictions on outstanding restricted stock awards will lapse.
For
purposes of the 2008 Stock Plan, “Change in Control” means the occurrence of any of the following events:
|
(i) |
A
change in the ownership of the Company which occurs on the date that any one person, or more than one person acting as a group
(“Person”), acquires ownership of the stock of the Company that, together with the stock held by such Person,
constitutes more than 50% of the total voting power of the stock of the Company, except that any change in the ownership of
the stock of the Company as a result of a private financing of the Company that is approved by the board of directors will
not be considered a Change in Control; |
|
|
|
|
(ii) |
If
the Company has a class of securities registered pursuant to Section 12 of the Exchange Act, a change in the effective control
of the Company which occurs on the date that a majority of members of the board of directors is replaced during any twelve
(12) month period by directors whose appointment or election is not endorsed by a majority of the members of the board of
directors prior to the date of the appointment or election. |
|
|
|
|
(iii) |
A
change in the ownership of a substantial portion of the Company’s assets which occurs on the date that any person acquires
(or has acquired during the twelve month period ending on the date of the most recent acquisition by such person or persons)
assets from the Company that have a total gross fair market value equal to or more than 50% of the total gross fair market
value of all of the assets of the Company immediately prior to such acquisition or acquisitions. |
2009
Stock Plan
The
2009 Stock Plan provides that in the event we merge with or into another corporation, or a Change in Control (as defined below)
occurs, each outstanding option and stock purchase right will be assumed or an equivalent option substituted by the successor
corporation or a parent or subsidiary of the successor corporation. In the event that the successor corporation in a merger or
Change in Control refuses to assume or substitute for the option or stock purchase right, then the optionee will fully vest in
and have the right to exercise the option or stock purchase right as to all of the optioned stock, including shares as to which
it would not otherwise be vested or exercisable; provided, however, that such exercise will only be permitted as and to the extent
it complies with Code Section 409A or does not cause the option or stock purchase right to cease to be exempt from that statute.
For
purposes of the 2009 Stock Plan, “Change in Control” means the occurrence of any of the following events:
|
(i) |
Any
“person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the “beneficial
owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of securities representing fifty percent
(50%) or more of the total voting power represented by our then outstanding voting securities; or |
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|
|
|
(ii) |
The
consummation of the sale or disposition by us of all or substantially all of our assets; or |
|
|
|
|
(iii) |
The
consummation of a merger or our consolidation with any other corporation, other than a merger or consolidation which would
result in our voting securities outstanding immediately prior thereto continuing to represent (either by remaining outstanding
or by being converted into voting securities of the surviving entity or its parent) at least 50% of the total voting power
represented by the our voting securities or such surviving entity or its parent outstanding immediately after such merger
or consolidation. Notwithstanding the foregoing, only a Change in Control event that also qualifies as a “change in
the ownership” or a “change in the effective control” of the Company or a “change in the ownership
of a substantial portion” of our assets within the meaning of Treasury Regulation Section 1.409A-3(i)(5) shall be recognized
as a Change of Control for purposes of triggering exercise, distribution or settlement rights under any option or stock purchase
right granted under the Stock Plan that is subject to Code Section 409A. |
2015
Equity Incentive Plan
The
2015 Equity Incentive Plan provides that notwithstanding any other provision of the 2015 Plan, in the event of a Change in Control
(as defined below), unless otherwise determined by the plan administrator, each outstanding award under the plan will be assumed
or an equivalent award substituted by the successor corporation or a parent or subsidiary of the successor corporation. In the
event that, or to the extent that, the successor corporation in a Change in Control refuses to assume or substitute for the award,
or if the plan administrator determines that such assumption or substitution is not desirable or is only desirable for a portion
of any outstanding award, then the plan administrator may take any or all of the following actions: (i) determine that an outstanding
award will accelerate and become exercisable, or determine that the restrictions and conditions on an outstanding award will lapse,
in whole or in part, as applicable, upon the Change of Control or upon such other event as the plan administrator determines;
(ii) require that a Grantee surrender his or her outstanding award, or any portion of such outstanding award, in exchange for
a payment by the Company, in cash or stock, as determined by the plan administrator, in an amount equal to the fair market value
of the vested portion of the award (with respect to options or stock appreciation rights, or other similar appreciation value
awards, such value shall be determined by the amount by which the then fair market value of the shares subject to the Grantee’s
unexercised award exceeds the any applicable exercise price or other grant price or base value or the award); or (iii) after giving
the Grantee an opportunity to exercise the vested portion of his or her outstanding award, terminate any or all unexercised portion
of the award at such time as the plan administrator deems appropriate. Such surrender or termination will take place as of the
date of the Change of Control or such other date as the plan administrator may specify.
For
purposes of the 2015 Plan, “Change in Control” means the occurrence of any of the following events:
(i)
A change in our ownership which occurs on the date that any one person, or more than one person acting as a group, or Person,
acquires ownership of our stock that, together with the stock held by such Person, constitutes more than 50% of the total voting
power of our stock, except that any change in the ownership of our stock as a result of a private financing that is approved by
our board of directors will not be considered a Change in Control; or
(ii)
If we have a class of securities registered pursuant to Section 12 of the Exchange Act, a change in our effective control which
occurs on the date that a majority of members of our board of directors is replaced during any twelve (12) month period by directors
whose appointment or election is not endorsed by a majority of the members of our board of directors prior to the date of the
appointment or election. For purposes of this clause (ii), if any Person is considered to be in effective control of our company,
the acquisition of additional control of our company by the same Person will not be considered a Change in Control; or
(iii)
A change in the ownership of a substantial portion of our assets which occurs on the date that any Person acquires (or has acquired
during the twelve (12) month period ending on the date of the most recent acquisition by such person or persons) assets from us
that have a total gross fair market value equal to or more than 50% of the total gross fair market value of all of our assets
immediately prior to such acquisition or acquisitions. For purposes of this subsection (iii), gross fair market value means the
value of our assets, or the value of the assets being disposed of, determined without regard to any liabilities associated with
such assets.
Persons
will be considered to be acting as a group if they are owners of a corporation that enters into a merger, consolidation, purchase
or acquisition of stock, or similar business transaction with us.
Compensation
of Directors
Non-Employee
Director Compensation Program
Prior
to our initial public offering, we did not pay compensation to our directors for their service on our board of directors. Effective
upon the closing of our initial public offering, our non-employee directors are entitled to receive the following compensation
for their services:
|
● |
Annual Cash Retainer — $20,000
|
|
|
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|
● |
Chairman of the
Board Cash Retainer — $15,000 |
|
|
|
|
● |
Audit Committee
Chair Retainer — $7,500 |
|
|
|
|
● |
Compensation Committee
Chair Retainer — $5,000 |
|
|
|
|
● |
Nominating and
Corporate Governance Committee Chair Retainer — $3,500 |
|
|
|
|
● |
Initial Equity
Grant — 10,000 shares |
|
|
|
|
● |
Annual Equity
Grant — 7,000 shares |
2015
Director Compensation
The
following table sets forth the compensation paid or earned for the fiscal year ended December 31, 2015 to our non-employee directors.
Compensation paid to Michael Step, Andrew Ritter, and Ira Ritter is presented as part of the “Summary Compensation Table
(2015 and 2014)” above. Our employee directors do not receive compensation for their service as directors.
Name
of Director | |
Fees
Earned and
Paid in Cash
($) | | |
Option
Awards(2)
($) | | |
All
other
compensation
($) | | |
Total
($) | |
Noah Doyle(1) | |
$ | — | | |
$ | — | | |
| — | | |
$ | — | |
Matthew W. Foehr | |
$ | 12,500 | | |
$ | 22,500 | | |
| — | | |
$ | 35,000 | |
Paul V. Maier | |
$ | 13,750 | | |
$ | 22,500 | | |
| — | | |
$ | 36,250 | |
Gerald T. Proehl | |
$ | 11,750 | | |
$ | 22,500 | | |
| — | | |
$ | 34,250 | |
(1) |
Mr.
Doyle has declined to receive any compensation for his service as director. |
|
|
(2) |
Represents
the aggregate grant date fair value of the Initial Equity Grants to acquire 10,000 shares of our common stock granted to our
non-employee directors (other than Mr. Doyle) during the 2015 fiscal year, computed in accordance with ASC 718. These options
vest 25% upon the first anniversary of the nonemployee director’s approximate date of joining the Board
of Directors with the remaining options vesting monthly in equal installments over 36 months. For a
discussion of the assumptions and methodologies used to value the options awards granted, see Note 8 –
“Stock Based Compensation” to our accompanying financial statements in this prospectus. As of
December 31, 2015, each of our non-employee directors (other than Mr. Doyle) held one option award to
purchase an aggregate of 10,000 shares of our common stock and no stock awards. Mr. Doyle held no stock awards or
option awards as of December 31, 2015. |
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth certain information regarding the beneficial ownership of our common stock as of December 30, 2015,
by:
|
● |
our named executive
officers; |
|
|
|
|
● |
each of our directors;
|
|
|
|
|
● |
all of our current
directors and executive officers as a group; and |
|
|
|
|
● |
each stockholder
known by us to own beneficially more than five percent of our common stock. |
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
Shares of common stock that may be acquired by an individual or group within 60 days of December 30, 2015, pursuant to the exercise
of options are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group, but
are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table.
The percentage of beneficial ownership of our common stock is calculated based on an aggregate of 8,582,009 shares outstanding
as of December 30, 2015.
Except
as indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment
power with respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by
such stockholders. Unless otherwise indicated, the address for each director and executive officer listed is: c/o Ritter Pharmaceuticals,
Inc., 1880 Century Park East #1000, Los Angeles, California 90067.
Beneficial
Owner | |
Number
of Shares
Beneficially Owned | | |
Percentage
of Common
Stock
Beneficially Owned | |
| |
| | |
| |
Five
Percent Stockholders | |
| | | |
| | |
Aspire
Capital Fund, LLC(1) | |
| 801,264 | | |
| 9.3 | % |
Javelin
Venture Partners GP, L.P.(2) | |
| 2,776,534 | | |
| 30.9 | % |
Stonehenge
Partners LLC(3)(4)(5) | |
| 817,271 | | |
| 9.5 | % |
Broadfin
Capital, LLC(6) | |
| 778,000 | | |
| 9.1 | % |
| |
| | | |
| | |
Executive
Officers, Directors and Director Nominees | |
| | | |
| | |
Michael
D. Step(7) | |
| 907,151 | | |
| 9.9 | % |
Andrew
J. Ritter(4)(8) | |
| 997,330 | | |
| 11. 4 | % |
Ira
E. Ritter(5)(9) | |
| 997,330 | | |
| 11. 4 | % |
Ellen
Mochizuki | |
| — | | |
| | * |
Noah Doyle(2)
(10) | |
| 2,799,261 | | |
| 31.1 | % |
Matthew
W. Foehr (11) | |
| 4,000 | | |
| | * |
Paul
V. Maier | |
| — | | |
| | * |
Gerald
T. Proehl | |
| 50,000 | | |
| | * |
All current executive
officers and directors as a group (8 persons) | |
| 4,937,801 | | |
| 48.1 | % |
* |
Represents beneficial
ownership of less than 1% of the shares of common stock. |
|
|
(1) |
The
address of Aspire Capital Fund, LLC is 155 North Wacker Drive, Suite 1600, Chicago, Illinois 60606. Consists of 188,864 Commitment
Shares, 500,000 Initial Purchase Shares and 112,400 shares purchased in the open market (based upon information provided to
us by Aspire Capital). |
(2)
|
Based
upon information contained in a Schedule 13D filed with the SEC on July 10, 2015 by Javelin Venture Partners, L.P. (“Javelin”),
Javelin Venture Partners I SPV I, LLC (“Javelin SPV”), Javelin Venture Partners GP, L.P. (“Javelin GP”)
and Javelin Venture Partners GP, LLC (“Javelin GP-GP,” together with Javelin, and Javelin SPV the “Javelin
Entities”). Javelin holds 2,047,804 shares directly and has the right to acquire 83,224 shares upon exercise of a warrant.
Javelin SPV holds 322,753 shares directly and has the right to acquire 322,753 shares upon exercise of a warrant. The address
of the Javelin Entities is One Rincon Center, 101 Spear Street, Suite 255, San Francisco, California 94105. As a Manager of
Javelin GP-GP, Noah Doyle may be deemed the beneficial owner of these shares. Mr. Doyle expressly disclaims beneficial ownership
over these shares except to the extent of his pecuniary interest therein. |
|
|
(3) |
The
address of Stonehenge Partners LLC is 21800 Oxnard Street, Suite 250, Woodland Hills, California 91367. |
|
|
(4) |
As
a managing partner of Stonehenge Partners LLC, Andrew Ritter may be deemed the beneficial owner of these shares. Andrew Ritter
expressly disclaims beneficial ownership of these shares except to the extent of his pecuniary interest therein. |
|
|
(5) |
As
a managing partner of Stonehenge Partners LLC, Ira Ritter may be deemed the beneficial owner of these shares. Ira Ritter expressly
disclaims beneficial ownership of these shares except to the extent of his pecuniary interest therein. |
|
|
(6) |
Based
upon information contained in a Schedule 13G filed with the SEC on July 1, 2015 by Broadfin Capital, LLC (“Broadfin
Capital”), Broadfin Healthcare Master Fund, Ltd. (“Broadfin Healthcare”), and Kevin Kotler with respect
to their shared power to vote and dispose of shares of common stock as of June 24, 2015. Mr. Kotler is the managing member
of Broadfin Capital and a director of Broadfin Healthcare. The address of Broadfin Capital and Mr. Kotler is 300 Park Avenue,
25th Floor, New York, NY 10022. The address of Broadfin Healthcare is 20 Genesis Close, Ansbacher House, Second Floor, P.O.
Box 1344, Grand Cayman KY1-1108, Cayman Islands. |
|
|
(7) |
Represents
shares underlying stock option awards that are currently exercisable or exercisable within 60 days of December 30, 2015. The
number of shares issuable upon the exercise of options includes 545,495 shares subject to options that are currently exercisable
but that are not subject to vesting within 60 days of December 30, 2015 and accordingly, if exercised, are subject to a repurchase
right until vested. In addition, Mr. Step acquired 27,000 shares in an open market purchase on January 7, 2016. |
|
|
(8) |
Includes
180,059 shares underlying stock option awards that are currently exercisable or exercisable within 60 days of December
30, 2015 and the shares beneficially owned by Stonehenge Partners LLC reflected in footnote (3) above. |
|
|
(9) |
Includes
180,059 shares underlying stock option awards that are currently exercisable or exercisable within 60 days of December
30, 2015 and the shares beneficially owned by Stonehenge Partners LLC reflected in footnote (3) above. |
|
|
(10) |
Includes
22,727 shares owned directly by Mr. Doyle and the shares beneficially owned by the Javelin Entities reflected in footnote
(2) above. |
|
|
(11) |
In addition, Mr. Foehr acquired 13,000 shares
in an open market purchase on January 8, 2016. |
CERTAIN
RELATIONSHIPS AND RELATED PERSON TRANSACTIONS
In
addition to the director and executive officer compensation arrangements discussed above in “Executive and Director Compensation,”
since January 1, 2013, we have been a party to the following transactions in which the amount involved exceeded $120,000 and in
which any director, executive officer or holder of more than 5% of our voting securities, whom we refer to as our principal stockholders,
or affiliates or immediate family members of our directors, executive officers and principal stockholders had or will have a material
interest. We believe that all of these transactions were on terms as favorable as could have been obtained from unrelated third
parties. All share numbers have been adjusted to reflect the 1-for-7.15
reverse stock split of our common stock. Preferred share issuances referred to below are as of their date of issuance. The preferred
stock described below converted into shares of our common stock on a 7.15-for-1 basis prior to the closing of our initial public
offering.
Transactions
with Andela Group Inc.
Prior
to and during his employment with the Company, Ira Ritter served as the chief executive officer of Andela Group Inc, or Andela,
a company he founded in 1987, which is involved in corporate management, strategic and financial consulting. From January 1, 2013
until the date of this prospectus, the Company incurred approximately $635,000 of expenses for services received from Andela.
Promissory
Notes issued to Javelin Venture Partners, L.P.
In
May, September and October of 2014, we issued three subordinated convertible promissory notes, or the 2014 Notes, in the aggregate
principal amount of $510,000 to Javelin. The 2014 Notes each bore interest at a rate of 8% per annum. On October 9, 2014,
we issued an unsecured promissory note in the principal amount of $70,000 to Javelin, which bore interest at a rate of 5% per
annum. These notes were converted into an aggregate of 595,052 shares of our Series C preferred stock in the Initial Series C
Closing (as described below).
Since
January 1, 2013, the largest principal amount outstanding to Javelin with respect to the 2012 Notes, the 2014 Notes and the October
2, 2014 unsecured note described above was $776,446.
Noah
Doyle, one of our directors, is the managing director of Javelin.
Series
B Preferred Stock issued to Javelin Venture Partners, L.P.
In
November 2013, we issued 293,999 shares of Series B preferred stock to Javelin for an aggregate purchase price of approximately
$350,000 (which consisted of cash and the cancellation of the 2012 Notes).
Series
C Preferred Stock Closings
On
December 4, 2014, we issued an aggregate of 595,052 shares of Series C preferred stock and warrants to purchase 83,224 shares
of our common stock to Javelin and 473,764 shares of Series C preferred stock and warrants to purchase 66,260 shares of our common
stock to Javelin SPV in the Initial Series C Closing for an aggregate purchase price of approximately $1.21 million (consisting
of cash and the cancellation of the 2014 Notes and the October 2, 2014 unsecured promissory note described above).
On
December 8, 2014, we issued 1,833,927 shares of Series C preferred stock and warrants to purchase 256,493 shares of our common
stock at an exercise price of $9.30 per share, to Javelin SPV in the Second Series C Closing for an aggregate cash purchase
price of approximately $2.39 million.
Initial
Public Offering
Certain
of our existing stockholders, as well as certain of our directors, purchased an aggregate of $4.3 million of shares of our common
stock in our initial public offering at the initial public offering price of $5.00 per share. Specifically, Javelin purchased
800,000 shares, Gerald Proehl purchased 50,000 shares, and Matthew Foehr purchased 4,000 shares.
Policy
for Approval of Related Person Transactions
Pursuant
to the written charter of our audit committee, the audit committee is responsible for reviewing and approving, prior to our entry
into any such transaction, all transactions in which we are a participant and in which any parties related to us, including our
executive officers, our directors, beneficial owners of more than 5% of our securities, immediate family members of the foregoing
persons and any other persons whom our board of directors determines may be considered related parties under Item 404 of Regulation
S-K, has or will have a direct or indirect material interest.
In
reviewing and approving such transactions, the audit committee will obtain, or will direct our management to obtain on its behalf,
all information that the committee believes to be relevant and important to a review of the transaction prior to its approval.
Following receipt of the necessary information, a discussion will be held of the relevant factors if deemed to be necessary by
the committee prior to approval. If a discussion is not deemed to be necessary, approval may be given by written consent of the
committee. This approval authority may also be delegated to the chair of the audit committee in some circumstances. No related
party transaction will be entered into prior to the completion of these procedures.
The
audit committee or its chair, as the case may be, will approve only those related party transactions that are determined to be
in, or not inconsistent with, the best interests of us and our stockholders, taking into account all available facts and circumstances
as the committee or the chair determines in good faith to be necessary in accordance with principles of Delaware law generally
applicable to directors of a Delaware corporation. These facts and circumstances will typically include, but not be limited to,
the benefits of the transaction to us; the impact on a director’s independence in the event the related party is a director,
an immediate family member of a director or an entity in which a director is a partner, stockholder or executive officer; the
availability of other sources for comparable products or services; the terms of the transaction; and the terms of comparable transactions
that would be available to unrelated third parties or to employees generally. No member of the audit committee shall participate
in any review, consideration or approval of any related party transaction with respect to which the member or any of his or her
immediate family members has an interest.
Indemnification
Agreements
We
have entered into indemnification agreements with each of our directors and officers. The indemnification agreements and our amended
and restated certificate of incorporation and amended and restated bylaws require us to indemnify our directors and officers to
the fullest extent permitted by Delaware law. See “Management — Limitation of Directors’ and Officers’
Liability and Indemnification.”
DESCRIPTION
OF CAPITAL STOCK
General
Our
authorized capital stock consists of 30,000,000 shares, all with a par value of $0.001 per share, 25,000,000 of which are designated
as common stock and 5,000,000 of which are designated as preferred stock.
The
following description of our capital stock and certain provisions of our amended and restated certificate of incorporation and
amended and restated bylaws are summaries and are qualified by reference to our amended and restated certificate of incorporation
and our amended and restated bylaws.
All
share numbers have been adjusted to reflect the 1-for-7.15 reverse stock split of our common stock. Preferred share issuances
referred to below are as of their date of issuance. The preferred stock described below converted into shares of our common stock
on a 7.15-for-1 basis prior to the closing of our initial public offering.
As
of December 30, 2015, we had 8,582,009 shares of our common stock outstanding which includes the 500,000 Initial Purchase Shares
and 188,864 Commitment Shares issued to Aspire Capital under the Purchase Agreement and zero shares of preferred stock outstanding.
As of December 30, 2015, we also had outstanding options to acquire 1,904,532 shares of our common stock, having a weighted-average
exercise price of $2.73 per share, and warrants to purchase an aggregate of 578,321 shares of our common stock.
Common
Stock
Pursuant
to the terms of our amended and restated certificate of incorporation, the holders of common stock are entitled to one vote per
share on all matters to be voted upon by the stockholders, except on matters relating solely to terms of preferred stock. Subject
to preferences that may be applicable to any outstanding preferred stock, the holders of common stock will be entitled to receive
ratably such dividends, if any, as may be declared from time to time by the board of directors out of funds legally available
therefor. See “Dividend Policy.” In the event of our liquidation, dissolution or winding up, the holders of our common
stock will be entitled to share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights
of preferred stock, if any, then outstanding. The holders of our common stock will have no preemptive or conversion rights or
other subscription rights. There will be no redemption or sinking fund provisions applicable to our common stock.
Warrants
In
December 2014, we issued an aggregate of 2,369,228 shares of Series C preferred stock and warrants, or the 2014 Warrants, to purchase
a like number of shares of our common stock, for aggregate gross proceeds of $3,081,893. All of the shares of Series C
preferred stock were converted into 331,358 shares of our common stock prior to the closing of the initial public offering. Each
2014 Warrant has a term of seven years and provides for the holder to purchase each share of our common stock covered thereby
at a purchase price of $9.30 per share of common stock.
In
connection with the Series C Financing, all of the 2014 Notes were converted into shares of Series C preferred stock. A total
of $535,000 unpaid principal plus accrued interest of $18,342 on the convertible notes converted into 567,529 shares of Series
C preferred stock, which were later converted into 79,374 shares of our common stock prior to the closing of our initial public
offering, and 79,374 2014 Warrants. A total of $70,000 unpaid principal plus accrued interest of $537 on a note payable was extinguished
and converted into 54,259 shares of Series C preferred stock, which were later converted into 7,589 shares of our common stock
prior to the closing of our initial public offering and 7,589 2014 Warrants.
Warrants
to Representative in Initial Public Offering
In
connection with our initial public offering, we issued to the representative of the underwriters warrants to purchase up to a
total of 160,000 shares of common stock. The warrants are exercisable at any time, and from time to time, in whole or in part,
during the four-year period commencing one year from the effective date of our initial public offering, and ending on the date
that is five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(i). The warrants are exercisable
at a per share price equal to $6.25 per share. The warrants provide for registration rights upon request, in certain cases. The
demand registration right provided will not be greater than five years from the effective date of the offering in compliance with
FINRA Rule 5110(f)(2)(G)(iv). The piggyback registration right provided will not be greater than seven years from the effective
date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(v). We will bear all fees and expenses attendant to registering
the securities issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The
exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including
in the event of a stock dividend or our recapitalization, reorganization, merger or consolidation. However, the warrant exercise
price or underlying shares will not be adjusted for issuances of shares of common stock at a price below the warrant exercise
price.
Preferred
Stock
Pursuant
to the terms of our amended and restated certificate of incorporation, our board of directors has the authority to issue preferred
stock in one or more classes or series and to fix the designations, powers, preferences and rights, and the qualifications, limitations
or restrictions thereof, including dividend rights, conversion right, voting rights, terms of redemption, liquidation preferences
and the number of shares constituting any class or series, without further vote or action by the stockholders. Although we have
no present plans to issue any shares of preferred stock, the issuance of shares of preferred stock, or the issuance of rights
to purchase such shares, could decrease the amount of earnings and assets available for distribution to the holders of common
stock, could adversely affect the rights and powers, including voting rights, of the common stock, and could have the effect of
delaying, deterring or preventing a change of control of us or an unsolicited acquisition proposal.
Registration
Rights
On
September 15, 2008, we entered into an Investors’ Rights Agreement with certain holders of our preferred stock. Such Investors’
Rights Agreement was amended and restated on November 17, 2010. The Amended and Restated Investors’ Rights Agreement was
amended on each of January 13, 2011, February 6, 2012, December 4, 2014 and June 9, 2015. The Amended and Restated Investors’
Rights Agreement, as amended, provides such holders with certain demand and piggyback registration rights with respect to shares
of our common stock into which the shares of our preferred stock are convertible.
Aspire
Capital Registration Rights
Concurrently
with entering into the Purchase Agreement, we also entered into the Registration Rights Agreement, in which we agreed to file
one or more registration statements as permissible and necessary to register under the Securities Act, the sale of the shares
of our common stock that have been and may be issued to Aspire Capital under the Purchase Agreement. This registration statement
is being registered pursuant to the Registration Rights Agreement.
Anti-Takeover
Effects of Delaware Law and Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
The
provisions of Delaware law and our amended and restated certificate of incorporation and amended and restated bylaws, could discourage
or make it more difficult to accomplish a proxy contest or other change in our management or the acquisition of control by a holder
of a substantial amount of our voting stock. It is possible that these provisions could make it more difficult to accomplish,
or could deter, transactions that stockholders may otherwise consider to be in their best interests or in our best interests.
These provisions are intended to enhance the likelihood of continuity and stability in the composition of our board of directors
and in the policies formulated by the board of directors and to discourage certain types of transactions that may involve an actual
or threatened change of our control. These provisions are designed to reduce our vulnerability to an unsolicited acquisition proposal
and to discourage certain tactics that may be used in proxy fights. Such provisions also may have the effect of preventing changes
in our management.
Delaware
Statutory Business Combinations Provision. We are subject to the anti-takeover provisions of Section 203 of the Delaware General
Corporation Law, or the DGCL. Section 203 prohibits a publicly-held Delaware corporation from engaging in a “business combination”
with an “interested stockholder” for a period of three years after the date of the transaction in which the person
became an interested stockholder, unless the business combination is, or the transaction in which the person became an interested
stockholder was, approved in a prescribed manner or another prescribed exception applies. For purposes of Section 203, a “business
combination” is defined broadly to include a merger, asset sale or other transaction resulting in a financial benefit to
the interested stockholder, and, subject to certain exceptions, an “interested stockholder” is a person who, together
with his or her affiliates and associates, owns, or within three years prior, did own, 15% or more of the corporation’s
voting stock.
Election
and Removal of Directors. Except as may otherwise be provided by the DGCL, any director or the entire board of directors may
be removed, with or without cause, at an annual meeting or a special meeting called for that purpose, by the affirmative vote
of the majority of the votes cast by the shares of our capital stock present in person or represented by proxy at such meeting
and entitled to vote thereon, provided a quorum is present. Vacancies on our board of directors resulting from the removal of
directors and newly created directorships resulting from any increase in the number of directors may be filled solely by the affirmative
vote of a majority of the remaining directors then in office (although less than a quorum) or by the sole remaining director.
This system of electing and removing directors may discourage a third party from making a tender offer or otherwise attempting
to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of our directors.
Our amended and restated certificate of incorporation and amended and restated bylaws do not provide for cumulative voting in
the election of directors.
Advance
Notice Provisions for Stockholder Proposals and Stockholder Nominations of Directors. Our amended and restated bylaws provide
that, for nominations to the board of directors or for other business to be properly brought by a stockholder before a meeting
of stockholders, the stockholder must first have given timely notice of the proposal in writing to our Secretary. For an annual
meeting, a stockholder’s notice generally must be delivered not less than 90 days or more than 120 days prior to the anniversary
of the previous year’s annual meeting.
Special
Meetings of Stockholders. Special meetings of the stockholders may be called at any time only by the board of directors, the
Chairman of the board of directors, the Chief Executive Officer or the President, subject to the rights of the holders of any
series of preferred stock then outstanding.
Blank-Check
Preferred Stock. Our board of directors will be authorized to issue, without stockholder approval, preferred stock, the rights
of which will be determined at the discretion of the board of directors and that, if issued, could operate as a “poison
pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors
does not approve.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Corporate Stock Transfer, Inc.
Stock
Market Listing
Our
common stock is listed on The NASDAQ Capital Market under the symbol “RTTR.”
SELLING
STOCKHOLDER
The
selling stockholder may from time to time offer and sell any or all of the shares of our common stock set forth below pursuant
to this prospectus. When we refer to the “selling stockholder” in this prospectus, we mean the entity listed in the
table below, and its respective pledgees, donees, permitted transferees, assignees, successors and others who later come to hold
any of the selling stockholder’s interests in shares of our common stock other than through a public sale.
The
following table sets forth, as of the date of this prospectus, the name of the selling stockholder for whom we are registering
shares for sale to the public, the number of shares of common stock beneficially owned by the selling stockholder prior to this
offering, the total number of shares of common stock that the selling stockholder may offer pursuant to this prospectus and the
number of shares of common stock that the selling stockholder will beneficially own after this offering. Except as noted below,
the selling stockholder does not have, or within the past three years has not had, any material relationship with us or any of
our predecessors or affiliates and the selling stockholder is not or was not affiliated with registered broker-dealers.
Based
on the information provided to us by the selling stockholder, assuming that the selling stockholder sells all of the shares of
our common stock beneficially owned by it that have been registered by us and does not acquire any additional shares during the
offering, the selling stockholder will not own any shares other than those appearing in the column entitled “Beneficial
Ownership After This Offering.” We cannot advise you as to whether the selling stockholder will in fact sell any or all
of such shares of common stock. In addition, the selling stockholder may have sold, transferred or otherwise disposed of, or may
sell, transfer or otherwise dispose of, at any time and from time to time, the shares of our common stock in transactions exempt
from the registration requirements of the Securities Act of 1933 after the date on which it provided the information set forth
in the table below.
|
|
|
|
|
|
|
|
|
|
|
Beneficial
Ownership After
this Offering(1) |
|
Name |
|
Shares
of Beneficially Owned Prior to this Offering |
|
|
Percentage
of Outstanding Shares Beneficially Owned Prior to this Offering |
|
|
Shares
of Common to be Sold in the Offering |
|
|
Number
of Shares |
|
|
%(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aspire Capital Fund,
LLC(3) |
|
|
801,264 |
(4) |
|
|
9.3 |
% |
|
|
1,577,699 |
|
|
|
112,400 |
|
|
|
1.2 |
% |
(1) |
Assumes
the sale of all shares of common stock registered pursuant to this prospectus, although the selling stockholder is under no
obligation known to us to sell any shares of common stock at this time. |
|
|
(2) |
Based
on 8,582,009 shares of common stock outstanding on December 30, 2015. |
|
|
(3) |
Aspire
Capital Partners LLC, or Aspire Partners, is the Managing Member of Aspire Capital Fund LLC, or Aspire Fund. SGM Holdings
Corp, or SGM, is the Managing Member of Aspire Partners. Mr. Steven G. Martin is the president and sole shareholder of SGM,
as well as a principal of Aspire Partners. Mr. Erik J. Brown is the president and sole shareholder of Red Cedar Capital Corp.,
or Red Cedar, which is a principal of Aspire Partners. Mr. Christos Komissopoulos is president and sole shareholder of Chrisko
Investors Inc., or Chrisko, which is a principal of Aspire Partners. Each of Aspire Partners, SGM, Red Cedar, Chrisko, Mr.
Martin, Mr. Brown, and Mr. Komissopoulos may be deemed to be a beneficial owner of common stock held by Aspire Fund. Each
of Aspire Partners, SGM, Red Cedar, Chrisko, Mr. Martin, Mr. Brown, and Mr. Komissopoulos disclaims beneficial ownership of
the common stock held by Aspire Fund. |
|
|
(4) |
As
of the date hereof, Aspire Capital holds 801,264 shares of our common stock, which includes 688,864 shares of our common stock
that have been acquired by Aspire Capital under the Purchase Agreement (consisting of the 500,000 Initial Purchase Shares
sold to Aspire Capital and the 188,864 shares we issued to Aspire Capital as a commitment fee) and 112,400 shares of our common
stock that were purchased by Aspire Capital in the open market (based upon information provided to us by Aspire Capital).
We may elect in our sole discretion to sell to Aspire Capital up to an additional 888,835 shares under the Purchase Agreement,
but Aspire Capital does not presently beneficially own those shares as determined in accordance with the rules of the SEC. |
PLAN
OF DISTRIBUTION
The
common stock offered by this prospectus is being offered by Aspire Capital, the selling stockholder. The common stock may be sold
or distributed from time to time by the selling stockholder directly to one or more purchasers or through brokers, dealers, or
underwriters who may act solely as agents at market prices prevailing at the time of sale, at prices related to the prevailing
market prices, at negotiated prices, or at fixed prices, which may be changed. The sale of the common stock offered by this prospectus
may be effected in one or more of the following methods:
|
● |
ordinary
brokers’ transactions; |
|
|
|
|
● |
transactions
involving cross or block trades; |
|
|
|
|
● |
through
brokers, dealers, or underwriters who may act solely as agents; |
|
|
|
|
● |
“at
the market” into an existing market for the common stock; |
|
|
|
|
● |
in
other ways not involving market makers or established business markets, including direct sales to purchasers or sales effected
through agents; |
|
|
|
|
● |
in
privately negotiated transactions; or |
|
|
|
|
● |
any
combination of the foregoing. |
In
order to comply with the securities laws of certain states, if applicable, the shares may be sold only through registered or licensed
brokers or dealers. In addition, in certain states, the shares may not be sold unless they have been registered or qualified for
sale in the state or an exemption from the registration or qualification requirement is available and complied with.
The
selling stockholder may also sell shares of common stock under Rule 144 promulgated under the Securities Act, if available, rather
than under this prospectus. In addition, the selling stockholder may transfer the shares of common stock by other means not described
in this prospectus.
Brokers,
dealers, underwriters, or agents participating in the distribution of the shares as agents may receive compensation in the form
of commissions, discounts, or concessions from the selling stockholder and/or purchasers of the common stock for whom the broker-dealers
may act as agent. Aspire Capital has informed us that each such broker-dealer will receive commissions from Aspire Capital which
will not exceed customary brokerage commissions.
Aspire
Capital is an “underwriter” within the meaning of the Securities Act.
Neither
we nor Aspire Capital can presently estimate the amount of compensation that any agent will receive. We know of no existing arrangements
between Aspire Capital, any other stockholder, broker, dealer, underwriter, or agent relating to the sale or distribution of the
shares offered by this prospectus. At the time a particular offer of shares is made, a prospectus supplement, if required, will
be distributed that will set forth the names of any agents, underwriters, or dealers and any compensation from the selling stockholder,
and any other required information.
We
will pay all of the expenses incident to the registration, offering, and sale of the shares to the public other than commissions
or discounts of underwriters, broker-dealers, or agents. We have agreed to indemnify Aspire Capital and certain other persons
against certain liabilities in connection with the offering of shares of common stock offered hereby, including liabilities arising
under the Securities Act or, if such indemnity is unavailable, to contribute amounts required to be paid in respect of such liabilities.
Aspire Capital has agreed to indemnify us against liabilities under the Securities Act that may arise from certain written information
furnished to us by Aspire Capital specifically for use in this prospectus or, if such indemnity is unavailable, to contribute
amounts required to be paid in respect of such liabilities.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling
persons, we have been advised that in the opinion of the SEC this indemnification is against public policy as expressed in the
Securities Act and is therefore, unenforceable.
Aspire
Capital and its affiliates have agreed not to engage in any direct or indirect short selling or hedging of our common stock during
the term of the Purchase Agreement.
We
have advised Aspire Capital that while it is engaged in a distribution of the shares included in this prospectus it is required
to comply with Regulation M promulgated under the Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation
M precludes the selling stockholder, any affiliated purchasers, and any broker-dealer or other person who participates in the
distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase any security which is the
subject of the distribution until the entire distribution is complete. Regulation M also prohibits any bids or purchases made
in order to stabilize the price of a security in connection with the distribution of that security. All of the foregoing may affect
the marketability of the shares offered hereby this prospectus.
We
may suspend the sale of shares by Aspire Capital pursuant to this prospectus for certain periods of time for certain reasons,
including if the prospectus is required to be supplemented or amended to include additional material information.
This
offering will terminate on the date that all shares offered by this prospectus have been sold by Aspire Capital.
LEGAL
MATTERS
Reed
Smith LLP, Los Angeles, California will pass upon the validity of the shares of common stock offered hereby.
EXPERTS
Mayer
Hoffman McCann P.C., our independent registered public accounting firm, has audited our balance sheets as of December 31, 2014
and 2013, and the related statements of operations, changes in securities subject to redemption and shareholders’ deficit
and cash flows for each of the two years in the period ended December 31, 2014, as set forth in their report, which report expresses
an unqualified opinion and includes an explanatory paragraph relating to our ability to continue as a going concern. We have included
our financial statements in this prospectus and in this registration statement in reliance on the report of Mayer Hoffman McCann
P.C. given on their authority as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a Registration Statement on Form S-1 under the Securities Act in connection with this offering of our
common stock by our selling stockholders. This Prospectus, which constitutes a part of the Registration Statement, does not contain
all of the information set forth in the registration statement, some items of which are contained in exhibits to the Registration
Statement as permitted by the rules and regulations of the SEC. For further information with respect to us and our common stock,
we refer you to the Registration Statement, including the exhibits and the financial statements and notes filed as a part of the
Registration Statement. Statements contained in this prospectus concerning the contents of any contract or any other document
are not necessarily complete. If a contract or document has been filed as an exhibit to the Registration Statement, please see
the copy of the contract or document that has been filed. Each statement in this prospectus relating to a contract or document
filed as an exhibit is qualified in all respects by the filed exhibit. The exhibits to the Registration Statement should be referenced
for the complete contents of these contracts and documents. A copy of the Registration Statement and the exhibits filed therewith
may be inspected without charge at the public reference room of the SEC, located at 100 F Street, N.E., Room 1580, Washington,
D.C. 20549. You may obtain information on the operation of the public reference rooms by calling the SEC at 1-800-SEC-0330. The
SEC also maintains an Internet website that contains reports, proxy statements, and other information about issuers, like us,
that file electronically with the SEC. The address of that website is www.sec.gov.
We
are subject to the information and reporting requirements of the Exchange Act and, in accordance with this law, we file periodic
reports, proxy statements, and other information with the SEC. These periodic reports, proxy statements, and other information
are available for inspection and copying at the SEC’s public reference facilities and the website of the SEC referred to
above. We also maintain a website at www.ritterpharmaceuticals.com. You may access our annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a)
or 15(d) of the Exchange Act with the SEC free of charge at our website (www.ritterpharmaceutical.com) as soon as reasonably
practicable after such material is electronically filed with, or furnished to, the SEC. The information contained in, or that
can be accessed through, our website is not incorporated by reference into this Prospectus.
RITTER
PHARMACEUTICALS, INC.
INDEX
TO FINANCIAL STATEMENTS
Report
of Independent Registered Public Accounting Firm
To the Board
of Directors and Stockholders
RITTER
PHARMACEUTICALS, INC.
We
have audited the accompanying balance sheets of Ritter Pharmaceuticals, Inc. (the “Company”) as of December 31, 2014
and 2013, and the related statements of operations, statements of changes in securities subject to redemption and stockholders’
deficit, and cash flows for each of the two years in the period ended December 31, 2014, and the related notes to the financial
statements. These financial statements are the responsibility of the Company’s management. Our responsibility is to express
an opinion on these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are
free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control
over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing
audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness
of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing
the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In
our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Ritter
Pharmaceuticals, Inc. as of December 31, 2014 and 2013, and results of its operations and its cash flows for each of the two years
in the period ended December 31, 2014, in conformity with accounting principles generally accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 2 to the financial statements, the Company has incurred recurring operating losses and is dependent on additional financing
to fund operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
Management’s plans in regard to these matters are described in Note 2 to the financial statements. The financial statements
do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the
amounts and classification of liabilities that may result from the outcome of this uncertainty.
/s/ Mayer Hoffman McCann P.C. |
|
|
|
Orange County, California |
|
March 13, 2015, except
for the matters noted in Note 11, as to which the date is April 24, 2015, and except for the effects of the reverse stock
split as described in Note 2 and Note 3, as to which the date is June 19, 2015. |
RITTER
PHARMACEUTICALS, INC.
BALANCE
SHEETS
| |
December
31, | |
| |
2014 | | |
2013 | |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash
and cash equivalents | |
$ | 2,747,248 | | |
$ | 448,226 | |
Prepaid expenses | |
| 57,115 | | |
| 76,636 | |
Total current assets | |
| 2,804,363 | | |
| 524,862 | |
Other assets | |
| 10,331 | | |
| 15,359 | |
Deferred offering costs | |
| 143,454 | | |
| — | |
Property and equipment, net | |
| 5,172 | | |
| 7,485 | |
Total Assets | |
$ | 2,963,320 | | |
$ | 547,706 | |
LIABILITIES AND STOCKHOLDERS’
DEFICIT | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,083,597 | | |
$ | 834,496 | |
Accrued expenses | |
| 168,635 | | |
| 27,443 | |
Notes payable | |
| — | | |
| 31,500 | |
Other liabilities | |
| 2,518 | | |
| 4,517 | |
Total current liabilities | |
| 1,254,750 | | |
| 897,956 | |
Preferred stock subject to redemption,
$0.001 par value, 16,378,646 and 11,878,646 shares authorized as of December 31, 2014 and December 31, 2013, respectively,
13,399,668 and 10,408,652 shares issued and outstanding at December 31, 2014 and December 2013, respectively. $9.1 million
aggregate liquidation preference of Series B cumulative preferred stock at December 31, 2014 | |
| 16,203,612 | | |
| 12,413,876 | |
Stockholders’ deficit | |
| | | |
| | |
Preferred stock, par value $0.001,
8,887,500 shares authorized, issued and outstanding as of December 31, 2014 and December 31, 2013 | |
| 8,888 | | |
| 8,888 | |
Common stock, par value $0.001, 50,000,000
and 26,500,000 shares authorized as of December 31, 2014 and December 31, 2013, respectively; 465,384 and 451,398 shares issued
and outstanding as of December 31, 2014 and December 31, 2013, respectively | |
| 465 | | |
| 451 | |
Additional paid-in
capital | |
| 3,399,924 | | |
| 2,059,347 | |
Accumulated
deficit | |
| (17,904,319 | ) | |
| (14,832,812 | ) |
Total
stockholders’ deficit | |
| (14,495,042 | ) | |
| (12,764,126 | ) |
Total Liabilities and Stockholders’
Deficit | |
$ | 2,963,320 | | |
$ | 547,706 | |
See
accompanying notes to financial statements
RITTER
PHARMACEUTICALS, INC.
STATEMENTS
OF OPERATIONS
| |
For
the Years Ended December 31, | |
| |
2014 | | |
2013 | |
Operating costs and expenses: | |
| | | |
| | |
Research
and development | |
$ | 113,931 | | |
$ | 461,551 | |
Patent costs | |
| 197,731 | | |
| 292,358 | |
General and administrative | |
| 1,969,960 | | |
| 1,356,888 | |
Total operating
expenses | |
| 2,281,622 | | |
| 2,110,797 | |
Operating loss | |
| (2,281,622 | ) | |
| (2,110,797 | ) |
Other expense (income): | |
| | | |
| | |
Interest income | |
| (525 | ) | |
| (1,677 | ) |
Interest expense | |
| 213,516 | | |
| 6,076 | |
Other income | |
| (21,148 | ) | |
| (19,365 | ) |
Total
other expense (income) | |
| 191,843 | | |
| (14,966 | ) |
Net loss | |
$ | (2,473,465 | ) | |
$ | (2,095,831 | ) |
Cumulative preferred stock dividends | |
| 589,462 | | |
| 547,303 | |
Accretion of discount on Series C preferred
stock | |
| 8,580 | | |
| — | |
Net loss applicable
to common stockholders | |
$ | (3,071,507 | ) | |
$ | (2,643,134 | ) |
Net loss per
common share – basic and diluted | |
$ | (6.79 | ) | |
$ | (5.86 | ) |
Weighted average common shares outstanding – basic
and diluted | |
| 452,509 | | |
| 451,398 | |
See
accompanying notes to financial statements
RITTER
PHARMACEUTICALS, INC.
STATEMENTS
OF CHANGES IN SECURITIES SUBJECT TO REDEMPTION AND STOCKHOLDERS’ DEFICIT
| |
Preferred | | |
Stockholders’
Deficit | | |
| |
| |
Stock
Subject to Redemption | | |
Preferred
Stock | | |
Common
Stock | | |
Additional
Paid-in | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
Balance at December
31, 2012 | |
| 9,885,423 | | |
$ | 11,093,677 | | |
| 8,887,500 | | |
$ | 8,888 | | |
| 451,398 | | |
$ | 451 | | |
$ | 2,032,697 | | |
$ | (12,189,678 | ) | |
$ | (10,147,642 | ) |
Conversion of note payable into shares | |
| 103,234 | | |
| 122,901 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 12,253 | | |
| — | | |
| 12,253 | |
Prepaid forward sale of Series B preferred
stock | |
| — | | |
| 150,000 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Issuance of shares subject to redemption | |
| 419,995 | | |
| 499,995 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Stock based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 14,397 | | |
| — | | |
| 14,397 | |
Cumulative dividends on Series B preferred
stock | |
| — | | |
| 547,303 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (547,303 | ) | |
| (547,303 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,095,831 | ) | |
| (2,095,831 | ) |
Balance at December 31, 2013 | |
| 10,408,652 | | |
$ | 12,413,876 | | |
| 8,887,500 | | |
$ | 8,888 | | |
| 451,398 | | |
$ | 451 | | |
$ | 2,059,347 | | |
$ | (14,832,812 | ) | |
$ | (12,764,126 | ) |
Conversion of notes payable into preferred
stock subject to redemption and warrants to purchase common stock | |
| 621,788 | | |
| 660,635 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 136,733 | | |
| — | | |
| 136,733 | |
Issuance of preferred stock subject
to redemption and warrants to purchase common stock, net of offering cost of $68,767 | |
| 2,369,228 | | |
| 2,531,059 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 482,068 | | |
| — | | |
| 482,068 | |
Exercise of options on common stock | |
| — | | |
| — | | |
| — | | |
| — | | |
| 13,986 | | |
| 14 | | |
| 14,386 | | |
| — | | |
| 14,400 | |
Stock based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 707,390 | | |
| — | | |
| 707,390 | |
Cumulative dividends on Series B preferred
stock | |
| — | | |
| 589,462 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (589,462 | ) | |
| (589,462 | ) |
Accretion of discount on Series C preferred
stock | |
| — | | |
| 8,580 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (8,580 | ) | |
| (8,580 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,473,465 | ) | |
| (2,473,465 | ) |
Balance at December 31, 2014 | |
| 13,399,668 | | |
$ | 16,203,612 | | |
| 8,887,500 | | |
$ | 8,888 | | |
| 465,384 | | |
$ | 465 | | |
$ | 3,399,924 | | |
$ | (17,904,319 | ) | |
$ | (14,495,042 | ) |
See
accompanying notes to financial statements
RITTER
PHARMACEUTICALS, INC.
STATEMENTS
OF CASH FLOWS
| |
For
the Years Ended December 31, | |
| |
2014 | | |
2013 | |
Cash flows from operating activities
| |
| | | |
| | |
Net
loss | |
$ | (2,473,465 | ) | |
$ | (2,095,831 | ) |
Adjustments to reconcile
net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 3,479 | | |
| 2,139 | |
Stock based compensation | |
| 707,390 | | |
| 14,397 | |
Change in fair value
of put embedded in convertible debt | |
| (21,148 | ) | |
| — | |
Accretion of discount
on convertible debt | |
| 10,192 | | |
| — | |
Non-cash interest
on conversion of debt | |
| 184,445 | | |
| — | |
Increase (decrease)
in cash attributable to changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses | |
| 19,521 | | |
| 1,655 | |
Other assets | |
| 5,028 | | |
| (7,903 | ) |
Accounts payable | |
| 249,101 | | |
| 119,742 | |
Accrued expenses | |
| 160,071 | | |
| 4,370 | |
Other
liabilities | |
| (1,999 | ) | |
| 4,517 | |
Net cash used in operating activities
| |
| (1,157,385 | ) | |
| (1,956,914 | ) |
Cash flows from investing activities
| |
| | | |
| | |
Purchase
of property and equipment | |
| (1,166 | ) | |
| (8,692 | ) |
Net cash used in investing activities
| |
| (1,166 | ) | |
| (8,692 | ) |
Cash flows from financing activities
| |
| | | |
| | |
Deferred offering
costs | |
| (143,454 | ) | |
| — | |
Proceeds from borrowing
under notes payable | |
| 605,000 | | |
| — | |
Repayment of borrowing
under note payable | |
| (31,500 | ) | |
| (6,000 | ) |
Net proceeds from
issuance of preferred stock subject to redemption and warrants to purchase common stock | |
| 3,013,127 | | |
| 499,995 | |
Proceeds received
on prepaid forward sale of preferred stock subject to redemption | |
| — | | |
| 150,000 | |
Proceeds from exercise
of options on common stock | |
| 14,400 | | |
| — | |
Net cash provided by financing activities
| |
| 3,457,573 | | |
| 643,995 | |
Net increase (decrease) in cash | |
| 2,299,022 | | |
| (1,321,611 | ) |
Cash at beginning of period | |
| 448,226 | | |
| 1,769,837 | |
Cash at end of period | |
$ | 2,747,248 | | |
$ | 448,226 | |
Non-cash financing activities: | |
| | | |
| | |
Conversion of account
payable to note payable | |
$ | — | | |
$ | 37,500 | |
Conversion of notes
payable into preferred stock subject to redemption and warrants to purchase common stock | |
$ | 612,923 | | |
$ | 135,154 | |
Cumulative preferred
stock dividends | |
$ | 589,462 | | |
$ | 547,303 | |
Accretion of Series
C | |
$ | 8,580 | | |
| | |
Cash paid for interest | |
$ | — | | |
$ | — | |
Cash paid for taxes | |
$ | — | | |
$ | — | |
See
accompanying notes to financial statements
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
NOTE
1 — ORGANIZATION AND PRINCIPAL ACTIVITIES
Ritter
Pharmaceuticals, Inc. (“Ritter” or the “Company”) is a Delaware corporation headquartered in Los Angeles,
California. The Company was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences,
LLC, and converted into a Delaware corporation on September 16, 2008.
The
Company is a privately held pharmaceutical company that develops novel therapeutic products that modulate the human gut microbiome
to treat gastrointestinal diseases. The Company’s leading compound, RP-G28, is currently under development for the treatment
of lactose intolerance. RP-G28 has the potential to become the first FDA-approved drug for the reduction of symptoms associated
with lactose intolerance, a debilitating disease that affects over 1 billion people worldwide.
NOTE
2 — BASIS OF PRESENTATION
The
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United
States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s
financial position for the periods presented.
All
common share amounts and per share amounts have been adjusted to reflect a 1-for-7.15 reverse stock split of the Company’s
common stock effected on June 17, 2015.
The
Company currently operates in one business segment focusing on the development and commercialization of RP-G28. The Company is
not organized by market and is managed and operated as one business. A single management team reports to the chief operating decision
maker, the Chief Executive Officer, who comprehensively manages the entire business. The Company does not currently operate any
separate lines of business or separate business entities.
Going
Concern
The
accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates,
among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company has
not yet realized any significant revenues from its planned principal operations. The Company had net losses of approximately $2.5
million and $2.1 million for the years ended December 31, 2014 and 2013, respectively, and had net cash used in operating activities
of approximately $1.2 million and $2 million for the years ended December 31, 2014 and 2013, respectively. These matters, among
others, raise substantial doubt about the Company’s ability to continue as a going concern.
Since
inception, the operations of the Company have been funded through the sale of common shares, preferred shares and convertible
debt. Management cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that
the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant
dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company’s ability to conduct
business. If the Company is not able to raise additional capital when required or on acceptable terms, the Company may have to
(i) significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates;
(ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less
favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates
or products that the Company would otherwise seek to develop or commercialize.
The
financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
NOTE
3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates
The
preparation of these financial statements in accordance with GAAP requires management to make estimates and assumptions that affect
the amounts reported in the financial statements and disclosed in the accompanying notes. Actual results may differ from those
estimates and such differences may be material to the financial statements. The more significant estimates and assumptions by
management include among others: the valuation allowance of deferred tax assets resulting from net operating losses and the valuation
of the Company’s common stock and options on the Company’s common stock.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Concentration
of Credit Risk
Cash
consists of checking accounts. While cash held by financial institutions may at times exceed federally insured limits, management
believes that no material credit or market risk exposure exists due to the high quality of the institutions. The Company has not
experienced any losses on such accounts.
Deferred
Offering Costs
Deferred
offering costs, which primarily consist of direct, incremental banking, legal and accounting fees relating to a planned public
offering of the Company’s common stock, are capitalized within long term assets. The deferred offering costs will be reclassified
to additional paid-in capital upon the consummation of the offering. In the event the offering is terminated, deferred offering
costs will be expensed.
Accrued
Expenses
The
Company incurs periodic expenses such as research and development, salaries, taxes, and professional fees. An adjusting entry
to accrue expenses is necessary when expenses have been incurred by the Company prior to them being paid. When a vendor’s
invoice is not received, the Company is required to estimate its accrued expenses. This process involves reviewing quotations
and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service
performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of
the actual cost. The majority of the Company’s service providers invoice monthly in arrears for services performed or when
contractual milestones are met. The Company estimates accrued expenses as of each balance sheet date based on facts and circumstances
known at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments
if necessary.
Property
and Equipment
Property
and equipment is carried at cost and depreciated on a straight-line basis over the estimated useful lives of assets, generally
five to seven years. Leasehold improvements are depreciated over the shorter of their estimated useful lives or the term of the
respective lease on a straight line basis. The cost of repairs and maintenance is expensed as incurred; major replacements and
improvements are capitalized. When assets are retired or disposed of, the cost and accumulated depreciated are removed from the
accounts, and any resulting gains or losses are included in income in the year of disposition. The Company examines the possibility
of decreases in the value of fixed assets when events or changes in circumstances reflect the fact that their recorded value may
not be recoverable.
Accounting
for Income Taxes
Deferred
tax assets and liabilities are recognized for the expected future consequences of events that have been reflected in the financial
statements. Deferred tax assets and liabilities are determined based on the differences between the book and tax basis of assets
and liabilities and operating loss carryforwards, using tax rates expected to be in effect for the years in which the differences
are expected to reverse. Such differences arise primarily from stock-based compensation and net operating loss carryforwards.
The Company records a valuation allowance to reduce deferred income tax assets when it is more likely than not that some portion
or all of the deferred tax asset will not be realized. Prior to September 15, 2008, the Company was a limited liability company
and the Company’s tax losses and credits generally flowed directly to the members.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Research
and Development
The
Company expenses the cost of research and development as incurred. Research and development expenses comprise costs incurred in
performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical
materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods
and services that will be used in future research and development activities are expensed when the activity is performed or when
the goods have been received, rather than when payment is made, in accordance with ASC 730, Research and Development.
Patent
Costs
The
Company has no historical data to support a probable future economic benefit for the arising patent applications, filing and prosecution
costs. Therefore, patent costs are expensed as incurred. Should the Company experience a legal cost to defend a patent in the
future, that cost would be capitalized only when it is part of the cost of retaining and obtaining the future economic benefit
of the patent. Costs related to an unsuccessful outcome would be expensed.
Fair
Value Measurements
Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the
inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).
These tiers include:
|
● |
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets; |
|
|
|
|
● |
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as
quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that
are not active; and |
|
|
|
|
● |
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own
assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value
drivers are unobservable. |
Fair
Value of Financial Instruments
ASC
820, Fair Value Measurement and Disclosures, requires all entities to disclose the fair value of financial instruments,
both assets and liabilities for which it is practicable to estimate fair value, and defines fair value of a financial instrument
as the amount at which the instrument could be exchanged in a current transaction between willing parties. As of December 31,
2014 and 2013, the recorded values of cash and cash equivalents, prepaid expenses, accounts payable, accrued expenses, and notes
payable approximate the fair values due to the short-term nature of the instruments.
Employee
Stock-based Compensation
Stock-based
compensation issued to employees and members of the Company’s Board of Directors is measured at the date of grant based
on the estimated fair value of the award, net of estimated forfeitures. The grant date fair value of a stock-based award is recognized
as an expense over the requisite service period of the award on a straight-line basis.
For
purposes of determining the variables used in the calculation of stock-based compensation issued to employees, the Company
performs an analysis of current market data and historical data to calculate an estimate of implied volatility, the expected term
of the option and the expected forfeiture rate. With the exception of the expected forfeiture rate, which is not an input, the
Company uses these estimates as variables in the Black-Scholes option pricing model. Depending upon the number of stock options
granted, any fluctuations in these calculations could have a material effect on the results presented in the Company’s statements
of operations. In addition, any differences between estimated forfeitures and actual forfeitures could also have a material impact
on the Company’s financial statements.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Stock-based
Compensation Issued to Non-employees
Common
stock issued to non-employees for acquiring goods or providing services is recognized at fair value when the goods are obtained
or over the service period, which is generally the vesting period. If the award contains performance conditions, the measurement
date of the award is the earlier of the date at which a commitment for performance by the non-employee is reached or the date
at which performance is reached. A performance commitment is reached when performance by the non-employee is probable because
of sufficiently large disincentives for nonperformance.
Net
Loss Per Share
The
Company determines basic loss per share and diluted loss per share in accordance with the provisions of ASC 260, “Earnings
per Share.” Basic net loss per share is calculated by dividing net loss by the weighted-average common shares outstanding.
Diluted net loss per share is calculated by dividing net loss by the weighted-average common shares outstanding during the period
using the treasury stock method or the two-class method, whichever is more dilutive. The potentially dilutive stock options issued
under the 2008 Stock plan and 2009 Stock Plan (described in Note 8, below) and the Series B preferred stock issuable under the
Put/Call (described in Note 7, below) were not considered in the computation of diluted net loss per share because they would
be anti-dilutive.
All
common share amounts and per share amounts have been adjusted to reflect a 1-for-7.15 reverse stock split of the Company’s
common stock effected on June 17, 2015.
Comprehensive
Income (Loss)
Comprehensive
income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner
sources. The Company is required to record all components of comprehensive loss in the financial statements in the period in which
they are recognized. Net income (loss) and other comprehensive loss, including foreign currency translation adjustments and unrealized
gains and losses on investments are reported, net of their related tax effect, to arrive at a comprehensive loss. For the years
ended December 31, 2014 and 2013, comprehensive loss was equal to the net loss.
Recent
Accounting Pronouncements
In
June 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an
Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. This ASU removes the definition of a development
stage entity from the ASC, thereby removing the financial reporting distinction between development stage entities and other reporting
entities from GAAP. In addition, the ASU eliminates the requirements for development stage entities to (1) present inception-to-date
information in the statements of operations, cash flows, and stockholders’ equity, (2) label the financial statements as
those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged,
and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been
in the development stage. In addition, ASU 2014-10 requires an entity that has not commenced principal operations to provide disclosures
about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what
those activities are being directed toward. This ASU is effective for annual reporting periods beginning after December 15, 2014,
and interim periods therein. Early adoption is permitted. The Company has elected to adopt this ASU and its adoption resulted
in the removal of previously required development stage disclosures. Adoption of this ASU did not impact the Company’s financial
position, operations or cash flows.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
In
August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic
205-40) — Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern,
which provides guidance regarding management’s responsibility to assess whether substantial doubt exists regarding the ability
to continue as a going concern and to provide related footnote disclosures. In connection with preparing financial statements
for each annual and interim reporting period, management should evaluate whether there are conditions or events, considered in
the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after
the date that the financial statements are issued (or within one year after the date that the financial statements are available
to be issued when applicable). This ASU is effective for the annual period ending after December 15, 2016, and for annual periods
and interim periods thereafter. Management is currently evaluating the new guidance and has not determined the impact this standard
may have on the Company’s financial statements.
NOTE
4 — PROPERTY AND EQUIPMENT
Property
and equipment consists of the following:
| |
| |
As
of December 31, | |
| |
Estimated
Life | |
2014
| | |
2013
| |
Computers
and equipment | |
5
years | |
$ | 5,487 | | |
$ | 4,320 | |
Furniture
and fixtures | |
7
years | |
| 4,270 | | |
| 4,270 | |
Leasehold
improvements | |
7
years | |
| — | | |
| 3,500 | |
Total
property and equipment | |
| |
| 9,757 | | |
| 12,090 | |
Accumulated
depreciation | |
| |
| (4,585 | ) | |
| (4,605 | ) |
Total
property and equipment, net of accumulated depreciation | |
| |
$ | 5,172 | | |
$ | 7,485 | |
In
2014, the Company disposed its leasehold improvements. Depreciation expense of approximately $3,500 and $2,100 was recognized
for the years ended December 31, 2014 and 2013, respectively, and is classified in general and administrative expense in the accompanying
Statements of Operations.
NOTE
5 — NOTES PAYABLE AND CONVERTIBLE NOTES PAYABLE
In
November 2013, the Company converted $37,500 of accounts payable into a note payable resulting from a compromise settlement with
a vendor to complete satisfaction of all rights, claims, causes of action, indebtedness, and assertions that the vendor may have
against the Company. The note payable has a term of one year and requires payments of $3,000 per month. The note payable
has no stated interest rate and, due to the short-term nature of the note, the Company did not impute interest on the note. The
note was fully paid in October 2014.
In
2014, the Company issued a combination of convertible notes payable and a note payable for a total principal balance of
$605,000 (the “2014 Notes”) to two investors and converted all of these outstanding notes, plus accrued interest,
into Series C preferred stock and warrants to purchase the Company’s common stock. These notes were convertible upon a qualified
equity financing, pursuant to which the Company sold, with the principal purpose of raising capital, a new class of preferred
stock with an aggregate sales price of not less than $3,000,000, including the principal and accrued but unpaid interest of any
notes which are converted into the preferred securities (“Qualified Equity Financing”), or upon a change of control.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
The
convertible notes payables with a principal balance of $535,000 settle by providing the holder with a variable number
of the Company’s shares with an aggregate fair value determined by reference to the debt principal outstanding. Because
the value that the holder receives at settlement does not vary with the value of the Company’s equity shares, the settlement
provision is not considered a conversion option for financial accounting purposes. Rather, these notes are recognized as share-settled
debt at amortized cost.
Details
of the 2014 Notes are as follows:
|
(a) |
In
May and September 2014, the Company issued a total of $455,000 of subordinated convertible promissory notes. These
notes have a term of 12 months and bear interest at a rate of 8% per annum until paid in full. These notes are convertible
upon a Qualified Equity Financing or upon a change of control at a price per share equal to seventy-five percent (75%) of
the price per share paid by the investors (other than the 2014 Note holders) participating in the Qualified Equity Financing.
The Company evaluated the change of control put embedded in these notes, which provides for cash settlement of these notes
at two (2) times the principal amount upon a change of control, in accordance with ASC 815-15-25. The embedded change of control
put is not clearly and closely related to the debt host instrument and therefore has been separately measured at fair value.
The proceeds received upon issuing these notes was first allocated to the fair value of the embedded put with the remainder
to the debt host instrument, resulting in a discount of approximately $21,000 to the face amount of the notes. The discount
is amortized to interest expense over the term of the debt. The Company amortized approximately $10,000 to interest expense
in the year ended December 31, 2014. Additionally, the Company recognized a gain of approximately $21,000 in the year ended
December 31, 2014 due to the reduction in fair value of the put resulted from the decreased probability of a change in control
occurring as the notes approached maturity and ultimate conversion. |
|
|
|
|
(b) |
In
October 2014, the Company issued an $80,000 subordinated convertible promissory note. These notes have a term of 12 months
and bear interest at a rate of 8% per annum until paid in full. The terms of this note provided an automatic conversion upon
a Qualified Equity Financing at a price per share equal to seventy-five percent (75%) of the price per share paid by the investors
(other than the 2014 Note holders) participating in the Qualified Equity Financing. |
|
|
|
|
(c) |
In
addition, the Company issued a $70,000 principal amount unsecured promissory note on October 9, 2014. This note bears interest
at a rate of 5% per annum until paid in full. All principal and accrued interest under this note must be paid upon demand
of the holder at any time after one year of the date of the note. |
As
described in Note 7, all of the Company’s outstanding debt was converted or exchanged for Series C preferred stock and warrants
to purchase common stock in December 2014.
NOTE
6 — COMMITMENTS AND CONTINGENCIES
Employment
Agreements
Michael
Step
On
December 2, 2014, the Company entered into a letter agreement (the “Step Letter Agreement”), with Michael Step, the
Company’s current Chief Executive Officer, setting forth the terms of his employment. The Step Letter Agreement provides
that Michael Step will be entitled to an annual base salary of $360,000 and a total of three grants of options to purchase
the Company’s common stock.
The
first two options entitle Michael Step to purchase 646,537 and 73,377 of the Company’s shares, respectively, for an exercise
price of $5.86 per share. Each of these options is immediately exercisable in full as of the date of the grant, with 44/48ths
of the total number of shares covered by each option subject to a right of repurchase by the Company upon termination of
Michael Step’s employment with the Company for any reason. This right of repurchase will lapse over a period of 44 months,
with 1/44th of the total number of shares subject to the right of repurchase lapsing on January 1, 2015 and on the
first day of each month thereafter. In addition, the right of repurchase will lapse in its entirety upon a termination of the
employment.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
The
third option will only become exercisable if by October 1, 2015, the Company has raised a minimum of $15,000,000 in one
or more public and/or private equity financing transactions during the prior twelve (12) month period. In the event the Company
closes such a qualified financing (a “Qualified Financing”), the third option will become immediately exercisable
for such number of shares of common stock as will, together with the shares subject to the first option, represent 7.5% of the
shares of common stock deemed to be outstanding on a fully-diluted basis after giving effect to the issuance of the third option.
In the event the Company does not close a Qualified Financing on or before October 1, 2015, the third option will terminate in
its entirety and be of no further force or effect. Seventy-five percent (75%) of the shares subject to the third option are subject
to a right of repurchase by the Company upon termination of Michael Step’s employment for any reason. This right of repurchase
will lapse with respect to 1/36th of the total number of shares subject to the right of repurchase on the first day
of each month following the date on which the third option first becomes exercisable. In addition, the right of repurchase will
lapse in its entirety upon Michael Step’s termination of employment.
Under
the terms of the agreement, Michael Step will be entitled to receive certain payments in the event his employment is terminated
under certain scenarios.
Andrew
Ritter and Ira Ritter
On
September 25, 2013, the Company’s Board of Directors approved the Executive Compensation Plan (the “Compensation Plan”)
setting forth the compensation to be paid to Andrew Ritter and Ira Ritter, the Company’s current President and also the
Company’s former Chief Executive Officer, and Chief Strategic Officer (“CSO”), respectively, for their contributions
to the Company. Pursuant to the terms of the Compensation Plan, the CEO’s salary is $225,000 per year and the CSO’s
salary is $210,000 per year. Each executive under the Compensation Plan is entitled to an annual car allowance which, if utilized,
results in a reduction of their base salary for the amount used in any one year.
Each
executive received options to purchase up to 48,951 shares of the Company’s common stock (each referred to in this section
as “Executive Options”) pursuant to the 2009 Stock Plan, which options will vest based on specific performance conditions,
described below.
Cash
Bonus and Executive Options Performance Conditions
Under
the Compensation Plan, each covered executive is entitled to the following cash payments and vests in Executive Options upon the
satisfaction of the events described below:
|
● |
FDA
Meeting Bonus Opportunities. In April 2013, each executive received a one-time cash bonus of $10,000 for meeting
with the FDA regarding RP-G28’s path to FDA approval. In addition, 2,360 shares of the Executive Options vested and
became exercisable as of grant date of September 25, 2013. The balance of the 3,496 shares vests ratably on a monthly basis
beginning on September 30, 2013. |
|
|
|
|
● |
Clinical
Trial Funding Commitment Bonus Opportunities. Each executive is entitled to receive a one-time cash bonus of $75,000
upon the Company’s receipt of a commitment by a third party to fund a Phase 2 or later clinical trial; provided, however,
that no such bonus may be paid at any time the Company has less than $2,000,000 in available cash. In addition, upon the satisfaction
of this milestone, 35% of 10,489 shares of the Executive Options will vest and become exercisable, with the balance of the
10,489 shares vesting in 36 equal monthly installments beginning on the last day of the following month. |
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
|
● |
Fundraising
Bonus Opportunities. Each executive is entitled to receive (i) a one-time cash bonus of $50,000 upon the sale
of additional equity capital for cash, in one or more closings after July 17, 2012, and/or the actual deployment of funds
by a third party for a clinical trial in an aggregate amount in excess of $2,000,000 and (ii) a one-time cash bonus
of $150,000 upon the sale of additional equity capital for cash, in one or more closings after July 17, 2012 and/or
the actual deployment of funds by a third party for a clinical trial in an aggregate amount in excess of $10,000,000 (which
such bonus will be reduced by any cash bonus paid under subsection (i)); provided, however, that no bonus under subsection
(i) or (ii) may be paid at any time the Company has less than $2,000,000 in available cash. In addition, upon the satisfaction
of the milestone described in subsection (i), 35% of 6,993 shares of the Executive Options will vest and become exercisable,
with the balance of the 6,993 shares vesting in 36 equal monthly installments beginning on the last day of the following month,
and, upon satisfaction of the milestone described in subsection (ii), 35% of 13,986 shares of the Executive Options will vest
and become exercisable, with the balance of the 13,986 shares vesting in 36 monthly installments beginning on the last day
of the following month. |
|
|
|
|
● |
License
Event Bonus Opportunities. Each executive is entitled to receive the following bonus payments in connection with the closing
of an exclusive license of RP-G28 and/or any future product candidate developed by the Company from time to time during the
term of the Compensation Plan by an/or any option to exclusively license such product candidate to a third party (referred
to under the Compensation Plan as a “License Event”) with a minimum upfront payment to the Company of
$2,000,000: |
|
● |
A
graduated cash bonus equal to (i) 5% of the Initial Period License Payment (as defined below) up to $5,000,000; (ii) 4% of
the Initial Period License Payment in excess of $5,000,000 up to $10,000,000; and (iii) 3% of the Initial Period License
Payment in excess of $10,000,000. In addition, upon the Company’s receipt of an Initial Period License Payment of more
than $2,000,000, 35% of 45,454 shares of their Executive Options will vest and become exercisable, with the balance of the
45,454 shares vesting in 36 monthly installments beginning on the last day of the following month. |
|
|
|
|
● |
A
cash bonus equal to 3% of any Annual Excess Milestone Payments (as defined below); provided, however that no such bonus may
be paid at any time the Company has less than $1,000,000 in available cash. In addition, upon the Company’s receipt
of an Annual Excess Milestone Payment, 35% of 6,993 shares of their Executive Options will vest and become exercisable, with
the balance of the 6,993 shares vesting in 36 monthly installments beginning on the last day of the following month. |
Notwithstanding
any of the vesting provisions set forth above, the total potential number of Executive Options that may vest will not exceed 48,951
and the Executive Options will automatically terminate for any options for which a vesting date or performance condition has not
been met by September 25, 2015.
For
purposes of the Compensation Plan, the term “Initial Period License Payment” means the aggregate amount in
cash received by the Company (not including any amount placed in escrow or subject to earn-outs, contingencies or other deferrals
or earmarked to pay or reimburse the Company for research and development activities) in respect of the License Event over a 24
month period beginning on the closing date of such License Event (which period is referred to therein as the “Initial
Period”). The term “Annual Excess Milestone Payments” means the amount in cash in excess of
$2,000,000 (not including any amounts placed in escrow or subject to earn-outs, contingencies or other deferrals) that is received
by the Company in respect of any Post-Closing Milestones (as defined below) in each 12-month period beginning on the expiration
of the Initial Period. The term “Post-Closing Milestones” means any post-closing payouts set forth in the definitive
transaction documentation executed in connection with a License Event; provided, however, that such amounts will not include any
amounts that are determined by the Board of Directors to comprise all or any portion of any upfront payment made in connection
with a License Event and any royalty payment based on product sales.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
The
Compensation Plan provides that in the event that the Company enters into more than one License Event with respect to a single
product candidate (i.e., for a separate field of use), then the proceeds of any such additional License Event will be included
with the proceeds of the original License Event for purposes of meeting any of the financial thresholds set forth above. Under
the terms of the Compensation Plan, receipt by the Company of more than one bona fide term sheet for a proposed
License Event with respect to RP-G28 will result in the payment of an additional 10% of any cash bonus earned as Clinical Trial
and Fundraising Bonus or a License Event Bonus.
Under
the terms of the Compensation Plan, each executive is entitled to receive certain payments in the event their employment is terminated
under certain scenarios.
On
December 2, 2014, the Company granted an aggregate of 453,413 options to the President and the CSO to purchase the Company’s
common stock listed as follow:
|
(i) |
20,979
fully vested options with an exercise price of $5.86, |
|
|
|
|
(ii) |
432,434
options which vest 25% upon the first anniversary of the vesting commencement date with the remaining options vesting monthly
in equal amounts over 36 months with an exercise price equal to $5.86 for the first 152,347 options covered thereby, $9.30
for the next 140,044 options covered thereby, and $13.23 for the remaining balance; |
Leases
The
Company leases office and storage space for its headquarters in California. Starting September 1, 2013, the Company ended its
previous lease agreement and executed a new office and storage lease agreement pursuant to a two-year agreement ending September
30, 2015, which calls for a minimum monthly rent of approximately $5,000 and an annual increase of 3%. Rent expense, recognized
on a straight-line basis, was approximately $60,000 and $79,000 for the years ended December 31, 2014 and 2013, respectively,
and is classified in general and administrative expenses in the accompanying Statements of Operations.
Legal
The
Company is not currently involved in any legal matters arising in the normal course of business. From time to time, the Company
could become involved in disputes and various litigation matters that arise in the normal course of business. These may include
disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically,
the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential
loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for
the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such
uncertainties, accruals are based on the best information available at the time. As additional information becomes available,
the Company reassesses the potential liability related to pending claims and litigation.
NOTE
7 — STOCKHOLDERS’ DEFICIT AND PREFERRED STOCK SUBJECT TO REDEMPTION
As
of December 31, 2014, the Company is authorized to issue 50,000,000 shares of common stock with a par value of $0.001
per share and 7,200,000 shares, 1,687,500 shares, 4,220,464 shares, 7,658,182 shares, and 4,500,000 shares of Series A-1, Series
A-2, Series A-3, Series B, and Series C preferred stock, respectively, with a par value of $0.001 per share. As of December
31, 2014, the Company has a total of 465,384 common shares issued and outstanding, and has 7,200,000, 1,687,500, 4,220,464, 6,188,188,
and 2,991,016 shares of Series A-1, Series A-2, Series A-3, Series B, and Series C preferred stock issued and outstanding, respectively.
The holders of outstanding shares of preferred stock will receive dividends, when, as and if declared by the Company’s Board
of Directors. The annual dividend rate is $0.00556 per share for the Series A-1 preferred stock, $0.032 per share for the Series
A-2 preferred stock, $0.04957 per share for the Series A-3 preferred stock, $0.09524 per share for the Series B preferred stock,
and $0.104 for Series C preferred stock (subject to adjustment). The right to receive dividends on shares of Series B preferred
stock is cumulative and the dividends accrue to holders of Series B preferred stock whether or not dividends are declared or paid
in a calendar year. Undeclared dividends in arrears for the Series B preferred stock was approximately $1.7 million and $1.1 million
as of December 31, 2014 and 2013, respectively. The right to receive dividends on shares of Series A and Series C preferred stock
is not cumulative and no right to such dividends shall accrue to holders of Series A or Series C preferred stock.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Each
share of the preferred stock will be automatically converted into fully-paid, non-assessable shares of common stock on a 7.15-for-1
basis, after giving effect to the Company’s reverse stock split, which was effected on June 17, 2015, (i) immediately prior
to the closing of a firm commitment underwritten initial public offering provided that the aggregate gross proceeds to the Corporation
are greater than $10,000,000 (“Qualified Public Offering”), or (ii) upon the written request for such conversion from
the holders of a majority of outstanding preferred stock.
In
the event of any liquidation, dissolution or winding up of the Company, either voluntary or involuntary, Series B and Series C
preferred stockholders receive an amount per share equal to the sum of the original purchase price of $1.19 plus all cumulative
but unpaid dividends for Series B, and $1.30 for Series C. If upon the liquidation, the available assets are insufficient to permit
payments to Series B and Series C holders, the entire assets legally available will be distributed in a pro rata basis among the
holders in proportion to the full amounts they would otherwise be entitled to receive. Upon the completion of the distribution
to the holders of the Series B and Series C preferred stock, the holders of the Series A preferred stock shall be entitled to
receive, prior and in preference to any distribution of any of the assets of the Company to the holders of all other capital stock
by reason of their ownership of such stock, an amount per share equal to the sum of the original issue price per share of
$0.07, $0.4, and $0.62 for Series A-1, Series A-2, and Series A-3 preferred stock, respectively, plus any accrued but unpaid dividends
on the preferred stock. Any remaining assets are distributed pro rata among the preferred and common shareholders.
At
any time after five years following the date of the initial issuance of the Series A-3, Series B, or Series C preferred stock,
as applicable, and at the option of the holders of a majority of the then outstanding shares of Series A-3, Series B, and Series
C preferred stock, voting together as a single class, the Company shall redeem any outstanding shares that have not been converted
by paying cash in an amount per share equal to the liquidation preference of $0.62 and $1.30 for the Series A-3 and Series
C preferred stock, respectively, and $1.19 per share, plus any accrued but unpaid dividends, for the Series B preferred stock.
Given the holders’ redemption option, the Series A-3, Series B, and Series C preferred stock is classified as preferred
stock subject to redemption in the accompanying Balance Sheets.
In
November 2013, the Company entered into a Series B Preferred Stock Purchase Agreement with certain investors raising approximately
$500,000, selling 419,995 shares of Series B preferred stock. Also in November 2013, the Company converted a total of approximately
$135,000 in convertible notes, including accrued interest of approximately $9,000, into 103,235 shares of Series B preferred stock.
In
December 2014, the Company issued an aggregate of 2,369,228 shares of Series C preferred stock, and warrants to purchase an aggregate
of 331,361 shares of the Company’s common stock (the “Warrants”), for aggregate gross proceeds of $3,081,893
(the “Series C Financing”). Each Warrant has a term of seven (7) years and provides for the holder to purchase one
share of the Company’s common stock at a purchase price of $9.30 per share of common stock. The Warrants are indexed
to the Company’s own stock and classified within stockholders’ equity pursuant to ASC 815-40. The gross proceeds were
allocated to the Series C preferred stock and Warrants on a relative fair value basis, resulting in a value of $1.10 for
the Series C preferred stock. The allocation of proceeds to the Warrants creates a discount of $0.20 in the initial carrying
value of the Series C preferred stock, which will be recognized as accretion, similar to preferred stock dividends, over the five-year
period prior to optional redemption by the holders.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
In
connection with the Series C Financing, all of the 2014 Notes were converted into shares of Series C preferred stock and Warrants
as follows:
|
● |
$535,000
unpaid principal plus accrued interest of $18,342 on convertible notes described in Note 5 converted into 567,529
shares of Series C preferred stock and 79,374 Warrants |
|
|
|
|
● |
$70,000
unpaid principal plus accrued interest of $537 on note payable described in Note 5 extinguished and converted into
54,259 shares of Series C preferred stock and 7,588 Warrants |
Notes
with an unpaid principal balance of $535,000 were converted into shares of Series C preferred stock and warrants to purchase
shares of common stock at 75% of the price paid by other purchasers of the Series C Financing. The Company recognized additional
interest expense of $184,445 upon conversion, calculated as the fair value of incremental shares and warrants received
by the holders compared to converting the outstanding debt and accrued interest at 100% of the price paid by purchasers of the
Series C Financing. The note with an unpaid principal balance of $70,000 was exchanged for shares of Series C preferred
stock and warrants to purchase shares of common stock at a price per share equal to the price per share paid by purchasers of
the Series C Financing. As such, there was no gain recognized or loss incurred upon extinguishment of the note.
Prepaid
Forward Sale of Preferred Stock
On
November 30, 2010, the Company concurrently entered into a Research and Development Agreement & License (“R&D Agreement”)
and a Put and Call Option Agreement (“Put/Call”) with two commonly controlled entities, Kolu Pohaku Technologies,
LLC (“KPT”) and Kolu Pohaku Management, LLC (“KPM”). The agreement was subsequently amended on July 6,
2011, September 30, 2011, February 6, 2012 and November 4, 2013 to increase the funding received by the Company.
Research
and Development Agreement & License
The
R&D Agreement between the Company and KPM and KPT, a Qualified High Technology Business within the meaning of Hawaii Revised
Statutes, call for KPT to make a series of payments to the Company totaling $1,750,000 in exchange for the Company performing
research and development activities in Hawaii for the benefit of KPT. The research project covered by the R&D Agreement is
for the initial phase of research performed in Hawaii, including the conduct of Phase II clinical trials, for RP-G28, the Company’s
drug candidate (the “KP Research”). Pursuant to the terms of the R&D Agreement, we maintain ownership of the results
of our ongoing research related to RP-G28, but KPT maintains ownership of the results of the KP Research. Inventions, developments,
and improvements arising out of the KP Research are owned by KPT. The Company bears any costs involved in obtaining patents for
any inventions, developments or improvements resulting from the KP Research. In exchange for the irrevocable, perpetual, exclusive,
worldwide right and license to the results of the KP Research, as they are generated under this R&D Agreement, the Company
will pay a quarterly royalty payment to KPT of $32,000 commencing March 31, 2015 and continuing through December 31, 2035.
Put
and Call Option Agreement
Anytime
after December 31, 2014, the Company has the option to put 1,469,994 shares of the Company’s Series B Preferred Stock (“Series
B”) to KPM and KPM has the option to call the same amount of shares of Series B from the Company. The number of shares was
determined by dividing the $1,750,000 of payments made by KPT to the Company under the R&D Agreement by the Series B original
issue price of $1.19. Irrespective of whether the above exercise date has passed, the Put/Call automatically exercises
immediately prior to any of the following events: (i) a qualified public offering by the Company, (ii) any liquidation or winding
up of the Company, (iii) license of the Company’s RP-G28 technology, or (iv) complete redemption or conversion of the Company’s
outstanding Series B. Exercise of the Put/Call under any scenario results in full satisfaction of the Company’s obligation
to make royalty payments to KPT under the R&D Agreement and KPT’s right, title and interest in the research conducted
pursuant to the R&D Agreement becomes the property of the Company. In the event of a breach of the R&D Agreement by the
Company, KPM & KPT’s sole remedy is to either exercise the call option, even if before December 31, 2014, or institute
an action for money damages in an amount not to exceed the payments under the R&D Agreement.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
The
R&D Agreement and the Put/Call have been recognized on a combined basis, pursuant to ASC 815-10-15-9, as a fully prepaid forward
sale contract on the Company’s Series B preferred stock. The fully prepaid forward sale contract is a hybrid instrument
comprising (1) a debt host instrument and (2) an embedded forward sale contract, requiring the Company to issue 1,469,994 shares
of the Company’s Series B for no further consideration. Payments received by the Company, totaling $1,750,000, are recognized
as preferred stock subject to redemption in the Balance Sheet.
NOTE
8 — STOCK-BASED COMPENSATION
Terms
of the Company’s share-based compensation are governed by the Company’s 2009 Stock Plan and 2008 Stock Plan (collectively
the “Plans”.) The Plans permit the Company to grant non-statutory stock options, incentive stock options and stock
purchase rights to the Company’s employees, outside directors and consultants; however, incentive stock options may only
be granted to the Company’s employees. As of December 31, 2014, the maximum aggregate number of shares of common stock that
may be issued is 69,930 and 2,046,158 shares under the 2009 Stock Plan and 2008 Stock Plan, respectively, after giving effect
to the 1-for-7.15 reverse stock split. The exercise price for each option is determined by the Board of Directors, but will be
(i) in the case of an incentive stock option, (A) granted to an employee who, at the time of grant of such option, is a 10% Holder,
no less than 110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than
100% of the fair market value per share on the date of grant; and (ii) in the case of a nonstatutory stock option, no less than
100% of the fair market value per share on the date of grant. The options awarded under the Plans shall vest as determined by
the Board of Directors but shall not exceed a ten-year period.
Options
Issued to Directors and Employees as Compensation
Pursuant
to the terms of the Plans, from inception to 2013, the Company has issued an aggregate of 206,172 options to its executive officers
and employees of the Company. Of these, 26,163 options were forfeited during 2013 and 180,009 options remain outstanding as of
December 31, 2013. The exercise prices of these option grants, as determined by the Company’s Board of Directors, range
from $0.79 to $1.27 per share, and a portion of these vest subject to certain performance conditions described in Note 6. The
Company’s management estimated that all of the performance conditions for the options granted to its executive officers
would be met by September 25, 2015.
In
2014, the Company granted an aggregate of 1,626,740 non-qualified 10-year term options to purchase the Company’s common
stock to its executive officers. As of December 31, 2014, 1,750,806 options remain outstanding. The exercise prices of these option
grants, as determined by the Company’s Board of Directors, range from $5.86 to $13.23 per share. The Company has recognized
an expense for these services within general and administrative expense in the accompanying Statements of Operations of approximately
$695,000 and $6,000 for the years ended December 31, 2014 and 2013, respectively. As of December 2014, there was approximately
$4.3 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements. This cost is
expected to be recognized over a weighted average period of 1.9 years.
Options
Issued to Nonemployees for Services Received
The
Company has issued options to purchase an aggregate of 106,573 shares of the Company since inception to its consultants under
the Plans. Of these, 68,662 options were forfeited or exercised, while 37,911 options remain outstanding as of December 31, 2014.
The exercise prices of the outstanding options, as determined by the Company’s Board of Directors, range from $0.72 to $1.14
per share. These outstanding options, with the exception of an option to purchase an aggregate of 7,271 shares granted to a consultant,
vest 25% upon the first anniversary of the vesting commencement date with the remaining options vesting monthly in equal amounts
over 36 months. In March 2011, the Company granted an option to a consultant to purchase an aggregate of 7,271 shares with an
exercise price of $1.00 which vests 25% on the date of grant with the remaining options vesting monthly in equal amounts
over 36 months. The Company recognized an expense for these services of approximately $13,000 and $8,400 for the years ended December
31, 2014 and December 31, 2013, respectively, within research and development expense in the accompanying Statements of Operations.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Options
Valuation
The
Company calculates the fair value of stock-based compensation awards granted to employees and nonemployees using the Black-Scholes
option-pricing method. If the Company determines that other methods are more reasonable, or other methods for calculating these
assumptions are prescribed by regulators, the fair value calculated for the Company’s stock options could change significantly.
Higher volatility and longer expected lives would result in an increase to stock-based compensation expense to non-employees determined
at the date of grant. Stock-based compensation expense to non-employees affects the Company’s selling, general and administrative
expenses and research and development expenses.
The
Black-Scholes option-pricing model requires the use of highly subjective and complex assumptions, which determine the fair value
of stock-based awards. The assumptions used in the Black-Scholes option-pricing method for the year ended December 31, 2014 is
set forth below:
| |
Year
ended December 31, 2014 | |
| |
Low
| | |
High
| |
Expected
dividend yield | |
| 0.00 | % | |
| 0.00 | % |
Expected
stock-price volatility | |
| 51.45 | % | |
| 64.24 | % |
Risk-free
interest rate | |
| 0.88 | % | |
| 3.04 | % |
Expected
term of options | |
| 5 | | |
| 10 | |
Stock price
| |
$ | 1.14 | | |
$ | 5.86 | |
|
● |
Expected
term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s
historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because
of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by
the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life
of the options. |
|
|
|
|
● |
Expected
volatility. As the Company’s common stock has never been publicly traded, the expected volatility is derived from
the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers
to be comparable to the Company’s business over a period approximately equal to the expected term. |
|
|
|
|
● |
Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero
coupon U.S. Treasury notes with maturities approximately equal to the expected term. |
|
|
|
|
● |
Expected
dividend. The expected dividend is assumed to be zero as the Company has never paid dividends and have no current plans
to pay any dividends on the Company’s common stock. |
In
addition to the assumptions used in the Black-Scholes option-pricing model, the Company also estimates a forfeiture rate to calculate
the stock-based compensation for the Company’s equity awards. The Company will continue to use judgment in evaluating the
expected volatility, expected terms and forfeiture rates utilized for the Company’s stock-based compensation calculations
on a prospective basis.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Significant
factors, assumptions and methodologies used in determining the estimated fair value of the Company’s common stock
The
Company is also required to estimate the fair value of the common stock underlying the Company’s stock-based awards when
performing the fair value calculations using the Black-Scholes option-pricing model. The Company’s Board of Directors, with
the assistance of management, determined the fair value of the Company’s common stock on each grant date. Option grants
are based on the estimated fair value of the Company’s common stock on the date of grant, which is determined by taking
into account several factors, including the following:
|
● |
the
prices at which the Company sold the Company’s convertible preferred stock and the rights, preferences, and privileges
of the convertible preferred stock relative to those of the Company’s common stock, including the liquidation preferences
of the convertible preferred stock; |
|
|
|
|
● |
important
developments in the Company’s operations; |
|
|
|
|
● |
the
Company’s actual operating results and financial performance; |
|
|
|
|
● |
conditions
in the Company’s industry and the economy in general; |
|
|
|
|
● |
stock
price performance of comparable public companies; |
|
|
|
|
● |
the
estimated likelihood of achieving a liquidity event, such as an IPO or an acquisition of the Company, given prevailing market
conditions; and |
|
|
|
|
● |
the
illiquidity of the common stock underlying stock options. |
The
table below presents the prices received from sales to third parties of the Company’s common stock and various classes of
the Company’s preferred stock from inception to date:
Year | | |
Share
Class | |
Price
per Share | |
2005 | | |
Common
Stock(a) | |
$ | 1.79 | |
2006 | | |
Series
A-2 Preferred Stock(a)(b) | |
$ | 0.40 | |
2008 – 2009 | | |
Series
A-3 Preferred Stock(b) | |
$ | 0.62 | |
2010 – 2013 | | |
Series
B Preferred Stock(b) | |
$ | 1.19 | |
2014 | | |
Series
C Preferred Stock(b) | |
$ | 1.30 | |
(a) |
After
giving effect to the Company’s conversion from an LLC to a corporation |
|
|
(b) |
Each
share of preferred stock is convertible into shares of the Company’s common stock on a 7.15-for-1 basis, after giving
effect to the Company’s reverse stock split, which was effected on June 17, 2015. |
For
options issued from inception to 2013, in determining the estimated fair value of the Company’s common stock, the Company’s
Board of Directors, with the assistance of management, used the market approach to estimate the enterprise value of the Company
in accordance with the American Institute of Certified Public Accountants (“AICPA”) Accounting and Valuation Guide,
Valuation of Privately-Held Company Equity Securities Issued as Compensation (the “AICPA Guide”) for the three valuation
dates of November 7, 2013, July 31, 2012, and December 31, 2010. The Market Approach is one of the three approaches (along with
the Income Approach and Asset Approach) used to estimate enterprise and equity value. The market approach employs analysis using
comparable companies in determining the value of the entity. Both public and private companies, if publicly available information
exists, are considered in the market approach. Two information points commonly available — company valuation
and transaction value — are used for their respective methodologies. There are a number of different methods
within the Market Approach that may be used: the three main methods utilized are: the Guideline Pubic Companies Method; the Guideline
Transactions Method; and the Backsolve Method.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
Given
the early stage of the Company, the Backsolve Method was used to estimate the fair value of the Company’s securities. This
method derives an implied market value of invested capital from a transaction involving a company’s own securities. The
price of a company’s security that was involved in a recent arms-length transaction is used as a reference point in an allocation
of value. The Company first raised additional capital through the sales of the Company’s LLC units. These units later converted
into common shares and preferred shares upon the Company’s conversion to a corporation. Subsequent to the Company’s
corporation conversion, the Company raised additional capital through the sales of the Company’s Series A-1, Series A-2,
Series A-3, Series B, and Series C preferred shares at the price of $0.07, $0.40, $0.62, $1.19, and $1.30, respectively.
The
Company valued LLC units and common stock (after converting to a corporation) from inception through 2009 by reference to the
Company’s sales of units and/or common stock & preferred stock over the period. Beginning in 2010, the Company valued
the Company’s common stock using the Backsolve Method. The Backsolve Method requires considering the rights and preferences
of each class of equity and solving for the total market value of invested capital that is consistent with a recent transaction
in the Company’s own securities, considering the rights and preferences of each class of equity. However, management has
decided that the liquidation preferences between the Company’s preferred shares and common shares are immaterial for a pre-revenue
company.
Per
the AICPA Guide, the Backsolve Method is generally the most reliable indicator of value of early-stage enterprises with no product
revenue or cash flow, if relevant and reliable transactions have occurred in the Company’s equity securities. This methodology
is also prescribed by the AICPA when a valuation is conducted in close proximity to the date of a financing transaction, and when
other methodologies are deemed less reliable.
The
stage of development of the Company’s compound was reflected in the Company’s selection of the term and volatility
estimates used in the analysis. The estimate of the term considers the Company’s existing cash runway and the time to the
next potential financing or liquidity event, while the volatility estimate reflects the relative riskiness of the Company’s
equity securities (or asset base) relative to the general stock market.
Management
estimated the implied market value of invested capital of the Company by backsolving for the purchase price of the Company’s
preferred shares for one common share through the option-pricing method. The premise of this method is that the transaction implied
a market price for a share which in turn implied values for the other classes of equity based on relative claims on equity value,
such as liquidation preferences and conversion rights. The application of the backsolve method considering the Company’s
capital structure yielded a total market value of invested capital of approximately $15.5 million, $14.4 million, and $8.9 million,
of which approximately $819,000, $870,000, and $670,000 were allocated to the total value of common stock as of the Company’s
three valuation dates of November 7, 2013, July 31, 2012, and December 31, 2010, respectively.
On
the three valuation dates of November 7, 2013, July 31, 2012, and December 31, 2010, after estimating the market value of invested
capital, the Company allocated it to the various equity classes comprising the subject company’s capitalization table. This
process ultimately results in creating a final estimate of value for the subject company’s underlying equity interests.
While there are many different value allocation methods, these various methods can be grouped into three general categories as
defined by the AICPA Guide, one of which is the Option-Pricing Method (OPM).
The
Company used the OPM to allocate market value of invested capital to the various equity classes and debt comprising the Company’s
capitalization structure. The Company chose the OPM over other acceptable methods due to the complex capital structure, the uncertainty
related to market conditions, and the lack of visibility on an imminent exit event. Under the OPM, each equity class is modeled
as a call option with a distinct claim on the equity of the Company. The option’s exercise price is based on the Company’s
total equity value available for each participating equity holder. The characteristics of each equity class determine the equity
class’ claim on the total equity value. By constructing a series of options in which the exercise price is set at incremental
levels of value, which correspond to the equity value necessary for each level of equity to participate, the Company determined
the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating
under that series, the result is the incremental value allocated to each class under that series.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
The
OPM relies on the Black-Scholes option-pricing model to value the call options on the Company’s invested capital. The following
inputs were applied in the Black-Scholes calculations of the OPM:
| |
Valuation
Dates | |
| |
November
7, 2013 | | |
July
31, 2012 | | |
December
31, 2010 | |
Risk-free
rate | |
| 0.55 | % | |
| 0.57 | % | |
| 2.01 | % |
Maturity
(years) | |
| 3.00 | | |
| 4.00 | | |
| 5.00 | |
Volatility
| |
| 58.00 | % | |
| 61.00 | % | |
| 61.00 | % |
Discounts
ranging from 35.8% to 40% were applied for lack of control and lack of marketability for the common stock. The calculation resulted
in a fair value for the common stock of $1.17, $1.19, and $1.03 per share as of the Company’s three valuation dates
of November 7, 2013, July 31, 2012, and December 31, 2010, respectively.
For
options issued in 2014, given the Company’s distinct possible exit scenarios of an initial public offering, the Company
used the probability weighted expected return method (PWERM) to estimate the fair value of the Company’s common equity.
Under this method, an analysis of future values of a company is performed for several likely liquidity scenarios. The value of
the common stock is determined for each scenario at the time of each future liquidity event and discounted back to the present
using a risk-adjusted discount rate. The present values of the common stock under each scenario are then weighted based on the
probability of each scenario occurring to determine the value for the common stock. The Company’s management determined
the probability weighting of potential liquidity events to be 45% for an initial public offering and 55% for other scenarios,
which represents all other likely outcomes for the Company.
Management
estimated the implied market value of invested capital of the Company by backsolving for the purchase price of the Company’s
preferred shares for one common share through the use of OPM. The application of the backsolve method considering the Company’s
capital structure yielded a total market value of invested capital of approximately $25.2 million, of which approximately $1.4
million was allocated to the total value of common stock as of the Company’s valuation date of October 31, 2014.
Given
the lack of marketability for the common stock, the Company applied a discount of 21.4% for using the average strike put option
approach. This resulted in a probability weighted common share value, after adjustment, of $5.86 per share as of valuation
date of October 31, 2014.
Stock-based
Compensation Summary Tables
Information
regarding the Company’s stock option grants to the Company’s employees and non-employees, along with the estimated
fair value per share of the underlying common stock, for stock options granted since 2005 is summarized as follows:
Grant
Date | | |
Number
of Common Shares
Underlying Options Granted | | |
Exercise
Price per Common
Share | | |
Estimated
Fair Value per Share
of
Common Stock | | |
Intrinsic
Value Option | |
2005 | | |
| 58,321 | | |
$ | 0.07 | | |
$ | 1.79 | | |
$ | 1.72 | |
2009 | | |
| 60,559 | | |
$ | 0.72 – $0.79
| | |
$ | 4.43 | | |
$ | 3.71 – $3.64 | |
2011 | | |
| 33,846 | | |
$ | 1.00 | | |
$ | 1.00 | | |
$ | 0.00 | |
2012 | | |
| 60,019 | | |
$ | 1.14 | | |
$ | 1.14 | | |
$ | 0.00 | |
2013 | | |
| 100,000 | | |
$ | 1.14 – $1.30 | | |
$ | 1.14 | | |
$ | 0.00 | |
2014 | | |
| 1,626,740 | | |
$ | 5.86 – $13.23 | | |
$ | 5.86 | | |
$ | 0.00 | |
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
The
following represents a summary of the options granted to employees and non-employees outstanding at December 31, 2014 and changes
during the period then ended:
| |
Options
| | |
Weighted
Average
Exercise Price | |
Outstanding
at December 31, 2013 | |
| 226,793 | | |
$ | 1.083 | |
Granted
| |
| 1,626,740 | | |
| 7.722 | |
Exercised/Expired/Forfeited
| |
| (64,816 | ) | |
| (0.888 | ) |
Outstanding
at December 31, 2014 | |
| 1,788,717 | | |
$ | 7.128 | |
Exercisable
at December 31, 2014 | |
| 162,237 | | |
$ | 4.053 | |
Expected
to be vested | |
| 1,626,480 | | |
$ | 7.434 | |
NOTE
9 — Related Party Transactions
A
director of the Company is a managing director of Javelin Venture Partners GP, LLC, the general partner of Javelin Venture Partners
GP, L.P., which holds a significant investment in the Company’s Series A-1, Series A-2, Series A-3, Series B, and Series
C preferred stock.
Prior
to and during his employment with the Company, Mr. Ira Ritter served as CEO of Andela Group Inc, (“Andela”) a company
he founded in 1987, which is involved in corporate management, strategic and financial consulting. During the years ended December
31, 2014 and 2013, the Company incurred approximately $176,000 and $197,000, respectively, of expenses for services received from
Andela, all of which were classified in general and administrative expenses in the Statements of Operations as Mr. Ritter was
an employee of the Company at the time of the services.
Other
than disclosed, the Company has not entered into or been a participant in any transaction in which a related party had or will
have a direct or indirect material interest.
NOTE
10 — INCOME TAXES
As
of December 31, 2014, the Company has net operating loss carryforwards of approximately $9.7 million available to reduce future
taxable income, if any, for Federal and state income tax purposes. The U.S. federal and state net operating loss carryforwards
will begin to expire in 2028.
As
of December 31, 2014, the Company has research and development credit carryforwards of approximately $200,000 available to reduce
future taxable income, if any, for Federal and state income tax purposes. The Federal credit carryforwards begin to expire in
2028. California credits have no expiration date.
Under
the Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss and research
tax credit carryforwards to offset taxable income may be limited based on cumulative changes in ownership. The Company has not
completed an analysis to determine whether any such limitations have been triggered as of December 31, 2014. The Company has no
income tax affect due to the recognition of a full valuation allowance on the expected tax benefits of future loss carry forwards
based on uncertainty surrounding realization of such assets.
RITTER
PHARMACEUTICALS, INC.
NOTES
TO FINANCIAL STATEMENTS
A
reconciliation of the statutory income tax rates and the Company’s effective tax rate is as follows:
| |
December
31, | |
| |
2014
| | |
2013
| |
Statutory
U.S. federal rate | |
| 34.0 | % | |
| 34.0 | % |
State
income tax, net of federal benefit | |
| 3.9 | % | |
| 3.9 | % |
Meals
& entertainment | |
| (0.3 | )% | |
| (0.4 | )% |
Others | |
| (0.5 | )% | |
| (2.8 | )% |
Forward
sale of preferred stock | |
| (2.3 | )% | |
| 0.0 | % |
Non-cash
interest on conversion | |
| (2.8 | )% | |
| 0.0 | % |
Valuation
allowance | |
| (32.0 | )% | |
| (34.7 | )% |
Provision
for income taxes | |
| 0.0 | % | |
| 0.0 | % |
The
tax effects of the temporary differences and carry forwards that give rise to deferred tax assets consist of the following:
| |
As
of December 31, | |
| |
2014
| | |
2013
| |
Deferred
tax assets: | |
| | | |
| | |
Net
operating loss carry forwards | |
$ | 3,675,012 | | |
$ | 3,306,227 | |
Patent
costs | |
| 318,652 | | |
| 243,722 | |
Capitalized
interest | |
| 85,568 | | |
| 8,518 | |
Accrued
vacation | |
| 10,237 | | |
| 6,192 | |
Research
and development credit | |
| 200,482 | | |
| 73,484 | |
Stock
based compensation | |
| 383,381 | | |
| 115,314 | |
Other
| |
| 4,460 | | |
| 4,828 | |
Gross
deferred tax assets | |
| 4,677,792 | | |
| 3,758,285 | |
Valuation
allowance | |
| (4,677,792 | ) | |
| (3,758,285 | ) |
Net
deferred tax assets | |
$ | — | | |
$ | — | |
In
2009 the Company adopted the accounting guidance for uncertainty in income taxes pursuant to ASC 740-10. The adoption of this
guidance did not have a material impact on the Company’s financial statements. The Company did not record any accruals for
income tax accounting uncertainties for the year ended December 31, 2014 and 2013, respectively.
The
Company’s policy is to recognize interest and penalties that would be assessed in relation to the settlement value of unrecognized
tax benefits as a component of income tax expense. The Company did not accrue either interest or penalties from inception through
December 31, 2014.
The
Company does not have any unrecognized tax benefits that will significantly decrease or increase within 12 months of December
31, 2014.
The
Company’s major tax jurisdictions are the United States and California. All of the Company’s tax years will remain
open three and four years for examination by the Federal and state tax authorities, respectively, from the date of utilization
of the net operating loss. The Company does not have any tax audits pending.
NOTE
11 — SUBSEQUENT EVENTS
On
March 26, 2015, the Company exercised its option to put 1,469,994 shares of the Company’s Series B to KPM (see Note 7).
The
Company has evaluated subsequent events through April 24, 2015, which is the date the financial statements were available to be
issued.
RITTER
PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS
| |
September
30, 2015 | | |
December
31, 2014 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current
assets | |
| | | |
| | |
Cash
and cash equivalents | |
$ | 16,244,741 | | |
$ | 2,747,248 | |
Prepaid
expenses | |
| 303,073 | | |
| 57,115 | |
Total
current assets | |
| 16,547,814 | | |
| 2,804,363 | |
Other
assets | |
| 15,624 | | |
| 10,331 | |
Deferred
offering costs | |
| — | | |
| 143,454 | |
Property
and equipment, net | |
| 14,250 | | |
| 5,172 | |
Total
Assets | |
$ | 16,577,688 | | |
$ | 2,963,320 | |
LIABILITIES
AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Current
liabilities | |
| | | |
| | |
Accounts
payable | |
$ | 836,953 | | |
$ | 1,083,597 | |
Accrued
expenses | |
| 296,109 | | |
| 168,635 | |
Other
liabilities | |
| — | | |
| 2,518 | |
Total
current liabilities | |
| 1,133,062 | | |
| 1,254,750 | |
Preferred
stock subject to redemption, $0.001 par value, no shares authorized, issued and outstanding as of September 30, 2015; 16,378,646
shares authorized, 13,399,668 shares issued and outstanding as of December 31, 2014 | |
| — | | |
| 16,203,612 | |
Stockholders’
deficit | |
| | | |
| | |
Preferred
stock, $0.001 par value, 5,000,000 shares authorized, no share issued and outstanding as of September 30, 2015; 8,887,500
shares authorized, issued and outstanding as of December 31, 2014 | |
| — | | |
| 8,888 | |
Common
stock, $0.001 par value; 25,000,000 shares authorized, 7,792,433 shares issued and outstanding as of September 30, 2015; 50,000,000
shares authorized, 465,378 shares issued and outstanding as of December 31, 2014 | |
| 7,792 | | |
| 465 | |
Additional
paid-in capital | |
| 40,296,961 | | |
| 3,399,924 | |
Accumulated
deficit | |
| (24,860,127 | ) | |
| (17,904,319 | ) |
Total
stockholders’ deficit | |
| 15,444,626 | | |
| (14,495,042 | ) |
Total
Liabilities and Stockholders’ Deficit | |
$ | 16,577,688 | | |
$ | 2,963,320 | |
See
accompanying notes to unaudited condensed financial statements
RITTER
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
| |
For
the Three Months Elided
September 30, | | |
For
the Nine Months Ended
September 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
Operating
costs and expenses | |
| | | |
| | | |
| | | |
| | |
Research
and development | |
$ | 1,505,116 | | |
$ | 57,745 | | |
$ | 1,584,086 | | |
$ | 69,161 | |
Patent
costs | |
| 47,611 | | |
| 29,891 | | |
| 160,033 | | |
| 94,055 | |
General
and administrative | |
| 1,555,938 | | |
| 166,301 | | |
| 4,860,676 | | |
| 763,388 | |
Total
operating costs and expenses | |
| 3,108,665 | | |
| 253,937 | | |
| 6,604,795 | | |
| 926,604 | |
| |
| | | |
| | | |
| | | |
| | |
Operating
loss | |
| (3,108,665 | ) | |
| (253,937 | ) | |
| (6,604,795 | ) | |
| (926,604 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other
income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest
income (expense), net | |
| 18,853 | | |
| (12,471 | ) | |
| 23,157 | | |
| (17,210 | ) |
Other
income | |
| 9,590 | | |
| - | | |
| 16,682 | | |
| - | |
Total
other income (expense) | |
| 28,443 | | |
| (12,471 | ) | |
| 39,839 | | |
| (17,210 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net
loss | |
$ | (3,080,222 | ) | |
$ | (266,408 | ) | |
$ | (6,564,956 | ) | |
$ | (943,814 | ) |
| |
| | | |
| | | |
| | | |
| | |
Cumulative
preferred stock dividends | |
| - | | |
| 147,128 | | |
| 327,569 | | |
| 441,913 | |
Accretion
of discount on Series C preferred stock | |
| - | | |
| - | | |
| 63,283 | | |
| - | |
Net
loss applicable to common stockholders | |
$ | (3,080,222 | ) | |
$ | (413,536 | ) | |
$ | (6,955,808 | ) | |
$ | (1,385,727 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net
loss per common share - basic and diluted | |
$ | 0.40 | | |
$ | (0.92 | ) | |
$ | (2.35 | ) | |
$ | (3.07 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted
average common shares outstanding - basic and diluted | |
| 7,792,050 | | |
| 451,393 | | |
| 2,961,263 | | |
| 451,393 | |
See
accompanying notes to unaudited condensed financial statements
RITTER
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
| |
For
the Nine Months Ended
September 30, | |
| |
2015 | | |
2014 | |
Cash
flows from operating activities | |
| | | |
| | |
Net
loss | |
$ | (6,564,956 | ) | |
$ | (943,814 | ) |
Adjustments
to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 1,022 | | |
| 3,175 | |
Stock
based compensation | |
| 2,432,045 | | |
| 3,448 | |
Accretion
of debt discount | |
| — | | |
| 6,416 | |
Prepaid
forward sale to supplies (Note 5) | |
| 416,000 | | |
| — | |
Changes
in operating assets and liabilities: | |
| | | |
| | |
Prepaid
expenses | |
| (245,958 | ) | |
| (54,921 | ) |
Other
assets | |
| (5,293 | ) | |
| 5,033 | |
Accounts
payable | |
| (246,644 | ) | |
| 90,545 | |
Accrued
expenses | |
| (86,087 | ) | |
| 4,734 | |
Other
liabilities | |
| (2,698 | ) | |
| (1,159 | ) |
Net
cash used in operating activities | |
| (4,302,569 | ) | |
| (886,543 | ) |
Cash
flows from investing activities | |
| | | |
| | |
Purchase
of property and equipment | |
| (10,100 | ) | |
| (1,166 | ) |
Net
cash used in investing activities | |
| (10,100 | ) | |
| (1,166 | ) |
Cash
flows from financing activities | |
| | | |
| | |
Commissions
and issuance costs of initial public offering | |
| (2,194,375 | ) | |
| — | |
Proceeds
from issuance of shares upon closing of initial public offering | |
| 20,000,000 | | |
| — | |
Proceeds
from exercising of stock options on common stock | |
| 4,537 | | |
| — | |
Bank
overdraft | |
| — | | |
| 11,483 | |
Net
proceeds of borrowing under notes payable | |
| — | | |
| 455,000 | |
Repayment
of note payable | |
| — | | |
| (27,000 | ) |
Net
cash provided by financing activities | |
| 17,810,162 | | |
| 439,483 | |
Net
increase (decrease) in cash | |
| 13,497,493 | | |
| (448,226 | ) |
Cash
at beginning of period | |
| 2,747,248 | | |
| 448,226 | |
Cash
at end of period | |
$ | 16,244,741 | | |
$ | — | |
Non-cash
financing activities: | |
| | | |
| | |
Accrual
of commissions and issuance costs of the initial public offering | |
$ | 213,561 | | |
$ | — | |
Deferred
offering costs reclassified to additional paid-in capital | |
$ | 665,603 | | |
$ | — | |
Conversion
of all outstanding preferred stock into common stock | |
$ | 8,888 | | |
$ | — | |
Conversion
of all outstanding preferred stock subject to redemption into common stock | |
$ | 16,594,464 | | |
$ | — | |
Common
stock subject to repurchase | |
$ | 180 | | |
$ | — | |
Cumulative
preferred stock dividends | |
$ | 327,569 | | |
$ | 441,913 | |
Accretion
of Series C | |
$ | 63,283 | | |
$ | — | |
Cash
paid for interest | |
$ | — | | |
$ | — | |
Cash
paid for taxes | |
$ | — | | |
$ | — | |
See
accompanying notes to unaudited condensed financial statements
RITTER
PHARMACEUTICALS, INC.
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
NOTE
1 — ORGANIZATION AND PRINCIPAL ACTIVITIES
Ritter
Pharmaceuticals, Inc. (“Ritter” or the “Company”) is a Delaware corporation headquartered in Los Angeles,
California. The Company was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences,
LLC, and converted into a Delaware corporation on September 16, 2008.
Ritter
Pharmaceuticals, Inc. develops therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases.
The Company conducts human gut health research by exploring metabolic capacity of the gut microbiota and translating the functionality
of prebiotic-based therapeutics. The Company’s lead compound, RP-G28 is currently under development for the treatment of
lactose intolerance. There currently is no drug approved by the Food and Drug Administration (“FDA”) for the treatment
of lactose intolerance, a debilitating disease that affects over 1 billion people worldwide.
On
June 24, 2015, the Company’s registration statement on Form S-1 (File No. 333-202924) relating to its initial public offering
of its common stock was declared effective by the Securities and Exchange Commission (“SEC”). The shares began trading
on the NASDAQ Capital Market on June 24, 2015. The initial public offering closed on June 29, 2015, and 4,000,000 shares of common
stock were sold at an initial public offering price of $5.00 per share.
The
Company paid to the underwriters underwriting discounts and commissions of approximately $1.6 million in connection with the offering.
In addition, the Company incurred expenses of approximately $1 million in connection with the offering. Thus, the net offering
proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses, were approximately $17.4
million.
NOTE
2 — BASIS OF PRESENTATION
The
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United
States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s
financial position for the periods presented. All common share amounts and per share amounts reflected in this Registration Statement
on Form S-1 have been adjusted to reflect a 1-for-7.15 reverse stock split of the Company’s common stock effected on June
17, 2015.
The
accompanying interim period unaudited condensed financial statements have also been prepared in accordance with GAAP and applicable
rules and regulations of the SEC regarding interim financial reporting. The condensed balance sheet as of September 30, 2015,
the condensed statements of operations for the three and nine months ended September 30, 2015 and 2014, and the condensed statements
of cash flows for the nine months ended September 30, 2015 and 2014, are unaudited, but include all adjustments, consisting only
of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating
results and cash flows for the periods presented. The condensed balance sheet at December 31, 2014 has been derived from audited
financial statements included in the Registration Statement on Form S-1 declared effective by the SEC on June 24, 2015. The results
for the three and nine months ended September 30, 2015 are not necessarily indicative of the results expected for the full fiscal
year or any other period.
The
accompanying interim period unaudited condensed financial statements and related financial information included in this Registration
Statement on Form S-1 should be read in conjunction with the audited financial statements and notes thereto included in the Company’s
Registration Statement on Form S-1 declared effective by the SEC on June 24, 2015.
The
Company currently operates in one business segment focusing on the development and commercialization of RP-G28. The Company is
not organized by market and is managed and operated as one business. A single management team reports to the chief operating decision
maker, the Chief Executive Officer, who comprehensively manages the entire business. The Company does not currently operate any
separate lines of business or separate business entities.
Liquidity
At
September 30, 2015, after consummation of the Company’s initial public offering, the Company had working capital of approximately
$15.4 million, an accumulated deficit of approximately $24.9 million, and cash and cash equivalents of approximately $16.2 million.
The Company has not generated any product revenues and has not achieved profitable operations. There is no assurance that profitable
operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities,
clinical and pre-clinical testing, and commercialization of the Company’s products will require significant additional financing.
The
Company believes that its existing cash will be sufficient to enable the Company to continue as a going concern for at least the
next twelve months. However, the Company will need to secure additional funding in the future, from one or more equity or debt
financings, collaborations, or other sources, in order to carry out all of its planned research and development activities. If
the Company is unable to obtain additional financing or generate license or product revenue, the lack of liquidity could have
a material adverse effect on the Company’s future prospects.
NOTE
3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
Company’s significant accounting policies are disclosed in Note 3 of the audited financial statements for the year ended
December 31, 2014 included in this Registration Statement on Form S-1. Since the date of such financial statements, there have
been no changes to the Company’s significant accounting policies, other than those detailed below.
Cash
and Cash Equivalents
The
Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents.
Deferred
Offering Costs
Deferred
offering costs, which primarily consist of direct, incremental banking, legal and accounting fees relating to the initial public
offering of the Company’s common stock, are capitalized within long term assets. The deferred offering costs were reclassified
to additional paid-in capital upon the consummation of the offering on June 29, 2015.
Net
Loss Per Share
The
Company determines basic loss per share and diluted loss per share in accordance with the provisions of Accounting Standards Codification
(“ASC”) 260, “Earnings per Share.” Basic net loss per share was calculated by dividing net loss
by the weighted-average common shares outstanding during the period. Diluted net loss per share was calculated by dividing net
loss by the weighted-average common shares outstanding during the period using the treasury stock method or the two-class method,
whichever is more dilutive. The potentially dilutive stock options issued under the 2015 Equity Incentive Plan (described in Note
8) and warrants on the Company’s common stock (described in Note 7) were not considered in the computation of diluted net
loss per share because they would be anti-dilutive.
All
common share amounts and per share amounts have been adjusted to reflect a 1-for-7.15 reverse stock split of the Company’s
common stock effected on June 17, 2015.
Recent
Accounting Pronouncements
In
August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40) — Disclosure of Uncertainties
about an Entity’s Ability to Continue as a Going Concern, which provides guidance regarding management’s responsibility
to assess whether substantial doubt exists regarding the ability to continue as a going concern and requires related footnote
disclosures. In connection with preparing financial statements for each annual and interim reporting period, management should
evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s
ability to continue as a going concern within one year after the date that the financial statements are issued (or within one
year after the date that the financial statements are available to be issued when applicable). This ASU is effective for the annual
period ending after December 15, 2016, and for annual periods and interim periods thereafter. Management is currently evaluating
the new guidance and has not determined the impact this standard may have on the Company’s financial statements.
NOTE
4 — PROPERTY AND EQUIPMENT
Property
and equipment consists of the following:
| |
Estimated
Life | |
September
30, 2015 | | |
December
31, 2014 | |
Computers
and equipment | |
5
years | |
$ | 6,636 | | |
$ | 5,487 | |
Furniture
and fixtures | |
7
years | |
| 13,221 | | |
| 4,270 | |
Total
property and equipment | |
| |
| 19,857 | | |
| 9,757 | |
Accumulated
depreciation | |
| |
| (5,607 | ) | |
| (4,585 | ) |
Total
property and equipment, net of accumulated depreciation | |
| |
$ | 14,250 | | |
$ | 5,172 | |
Depreciation
expense of approximately $400 and $600 was recognized for the three months ended September 30, 2015 and 2014, respectively, and
approximately $1,000 and $3,000 for the nine months ended September 30, 2015 and 2014, respectively and is classified in general
and administrative expense in the accompanying Unaudited Condensed Statements of Operations.
NOTE
5 — COMMITMENTS AND CONTINGENCIES
Employment
Agreements
Michael
Step
On
December 2, 2014, Michael Step accepted an offer letter from the Company setting forth the terms of his employment as Chief Executive
Officer. The offer letter provides that Michael Step is entitled to an annual base salary of $360,000 and a total of three grants
of options to purchase the Company’s common stock.
The
first two options entitle Michael Step to purchase 646,537 and 73,777 of the Company’s shares, respectively, for an exercise
price of $5.86 per share. Each of these options was immediately exercisable in full as of the date of the grant, with 44/48ths
of the total number of shares covered by each option subject to a right of repurchase by the Company upon termination of Michael
Step’s employment with the Company for any reason. This right of repurchase lapses over a period of 44 months, with 1/44th
of the total number of shares subject to the right of repurchase lapsing on January 1, 2015 and on the first day of each month
thereafter. In addition, the right of repurchase will lapse in its entirety upon a termination of the employment under certain
circumstances.
The
third option became exercisable upon the closing of the Company’s initial public offering on June 29, 2015. The option is
for a total of 163,799 shares of the Company’s common stock, which, together with the shares subject to the first option,
represents 7.5% of the shares of common stock deemed to be outstanding at June 29, 2015 on a fully-diluted basis after giving
effect to the number of shares subject to the third option. Seventy-five percent (75%) of the shares subject to the third option
are subject to a right of repurchase by the Company upon termination of Michael Step’s employment for any reason. This right
of repurchase lapses with respect to 1/36th of the total number of shares subject to the right of repurchase on the first day
of each month following the date on which the third option became exercisable. In addition, the right of repurchase will lapse
in its entirety upon Michael Step’s termination of employment under certain circumstances. Additionally, under the terms
of his Executive Severance and Change in Control Agreement, also effective on December 2, 2014, Michael Step is entitled to receive
certain payments in the event his employment is terminated under certain scenarios.
Andrew
Ritter and Ira Ritter
On
September 25, 2013, the Company’s Board of Directors approved the Executive Compensation Plan (the “Compensation Plan”)
setting forth certain compensation to be paid to Andrew Ritter, the Company’s current President and former Chief Executive
Officer, and Ira Ritter, the Company’s current Chief Strategic Officer (“CSO”) for their contributions to the
Company. Effective June 29, 2015, in connection with the Company’s initial public offering, Andrew Ritter and Ira Ritter
accepted offer letters from the Company setting forth the terms of their employment as President and CSO, respectively, of the
Company. The offer letters superseded the Compensation Plan.
Their
respective offer letters provide that that Andrew Ritter is entitled to an annual base salary of $310,000 and Ira Ritter is entitled
to an annual base salary of $295,000. In accordance with his offer letter, Andrew Ritter also became entitled to receive up to
$180,000 payable over a three year period for tuition reimbursement. As of September 30, 2015, the Company paid an aggregate of
$60,000 and accrued $92,500 in tuition reimbursement for Andrew Ritter and recognized such amount in general and administrative
expenses in the accompanying Unaudited Condensed Statements of Operations in the three and nine month periods ending September
30, 2015.
Additionally,
under the terms of their Executive Severance and Change in Control Agreements, also effective on June 29, 2015, Andrew Ritter
and Ira Ritter are entitled to receive certain payments in the event their employment is terminated under certain scenarios.
Pursuant
to their respective offer letters, Andrew Ritter and Ira Ritter each have the opportunity to earn an annual bonus based upon a
percentage of their base salary and the achievement of specific performance as determined by the Company. The initial target bonus
opportunities are 40% and 35% of the base salary for Andrew Ritter and Ira Ritter, respectively.
Pursuant
to the Compensation Plan, as in effect prior to entering into their offer letters, Andrew Ritter and Ira Ritter had bonus opportunities
to, upon the satisfaction of the events described below, each potentially receive the following cash payments and each potentially
receive the following options to purchase up to 48,951 shares of the Company’s common stock (the “Executive Options”)
pursuant to the 2008 Stock Plan:
FDA
Meeting Bonus Opportunities. Each executive was entitled to receive, and in April 2013 each executive received, a one-time
cash bonus of $10,000 for a milestone associated with meeting with the FDA regarding RP-G28’s path to FDA approval. In addition,
upon satisfaction of this milestone, the executives became entitled to 3,496 of the Executive Options. 2,360 shares of the Executive
Options vested and became exercisable as of the grant date of September 25, 2013, with the balance of the 1,136 shares vesting
ratably in 36 equal monthly installment beginning on September 30, 2013.
Clinical
Trial Funding Commitment Bonus Opportunities. Each executive was entitled to receive a one-time cash bonus of $75,000 upon
the Company’s receipt of a commitment by a third party to fund a Phase 2 or later clinical trial; provided, however, that
no such bonus would be paid at any time the Company had less than $2,000,000 in available cash. In addition, upon the satisfaction
of this milestone, 35% of 10,489 shares of the Executive Options would vest and become exercisable, with the balance of the 10,489
shares vesting in 36 equal monthly installments beginning on the last day of the following month. The Board of Directors determined
that this milestone was satisfied; accordingly, each executive received a bonus of $75,000 which has been recognized in general
and administrative expenses in the accompanying Unaudited Condensed Financial Statements.
Fundraising
Bonus Opportunities. Each executive was entitled to receive (i) a one-time cash bonus of $50,000 upon the sale of additional
equity capital for cash, in one or more closings after July 17, 2012, and/or the actual deployment of funds by a third party for
a clinical trial in an aggregate amount in excess of $2,000,000 and (ii) a one-time cash bonus of $150,000 upon the sale of additional
equity capital for cash, in one or more closings after July 17, 2012 and/or the actual deployment of funds by a third party for
a clinical trial in an aggregate amount in excess of $10,000,000 (which such bonus would be reduced by any cash bonus paid under
subsection (i)); provided, however, that no bonus under subsection (i) or (ii) would be paid at any time the Company had less
than $2,000,000 in available cash. In addition, upon the satisfaction of the milestone described in subsection (i), 35% of 6,993
shares of the Executive Options would vest and become exercisable, with the balance of the 6,993 shares vesting in 36 equal monthly
installments beginning on the last day of the following month, and, upon satisfaction of the milestone described in subsection
(ii), 35% of 13,986 shares of the Executive Options would vest and become exercisable, with the balance of the 13,986 shares vesting
in 36 monthly installments beginning on the last day of the following month. The Board of Directors determined that this milestone
as described in subsection (ii) above was satisfied upon the closing of the Company’s initial public offering on June 29,
2015 raising approximately $17.4 million, net of offering costs; accordingly, each executive received a bonus of $150,000 which
has been recognized in general and administrative expenses in the accompanying Unaudited Condensed Statements of Operations in
the nine month periods ending September 30, 2015. In addition, 4,895 shares of the Executive Options vested and became exercisable
as of June 29, 2015, with the balance of 9,091 shares vesting ratably on a monthly basis beginning July 31, 2015.
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License
Event Bonus Opportunities. Each executive was entitled to receive the following bonus payments in connection with the
closing of an exclusive license of RP-G28 and/or any future product candidate developed by the Company from time to time during
the term of the Compensation Plan by and/or any option to exclusively license such product candidate to a third party (referred
to under the Compensation Plan as a “License Event”) with a minimum upfront payment to the Company of $2,000,000: |
A
graduated cash bonus equal to (i) 5% of the Initial Period License Payment (as defined in the Compensation Plan) up to $5,000,000;
(ii) 4% of the Initial Period License Payment in excess of $5,000,000 up to $10,000,000; and (iii) 3% of the Initial Period License
Payment in excess of $10,000,000. In addition, upon the Company’s receipt of an Initial Period License Payment of more than
$2,000,000, 35% of 45,454 shares of their Executive Options will vest and become exercisable, with the balance of the 45,454 shares
vesting in 36 monthly installments beginning on the last day of the following month.
A
cash bonus equal to 3% of any Annual Excess Milestone Payments (as defined in the Compensation Plan); provided, however that no
such bonus may be paid at any time the Company has less than $1,000,000 in available cash. In addition, upon the Company’s
receipt of an Annual Excess Milestone Payment, 35% of 6,993 shares of their Executive Options will vest and become exercisable,
with the balance of the 6,993 shares vesting in 36 monthly installments beginning on the last day of the following month.
As
of September 30, 2015, 27,972 of the maximum 48,951 Executive Options potentially issuable to each executive had been issued to
each executive subject to the vesting conditions described above.
Research
and Development Arrangement
Effective
July 24, 2015, the Company entered into an amended Clinical Supply and Cooperation Agreement (the “Amended Supply Agreement”)
with Ricerche Sperimentali Montale SpA (“Ricerche”) and Inalco SpA (collectively, “RSM”). The Amended
Supply Agreement amends certain terms of the Clinical Supply and Cooperation Agreement, dated December 16, 2009, amended on September
25, 2010 (the “Existing Supply Agreement”).
Under
the Existing Supply Agreement, RSM granted the Company an exclusive worldwide option in a specified field and territory to assignment
of all right, title and interest to a purified Galacto-oligosaccharides product (“Improved GOS”), the composition
of matter of the Improved GOS and any information relating to the Improved GOS, including certain specified technical information
and other intellectual property rights (the “Improved GOS IP”). Pursuant to the amended terms, the Company may exercise
the option by paying RSM $800,000 within ten days after the effective date of the Amended Supply Agreement. The Company exercised
the option on July 30, 2015 and RSM is transferring the Improved GOS IP to the Company. Under the terms of the existing agreement,
if a further option payment of $1 million due in the future is not made, the Company may be required to return the Improved GOS
IP to RSM.
The
Amended Supply Agreement also provides that the Company must pay RSM $400,000 within 10 days following FDA approval of a new drug
application for the first product owned or controlled by the Company using Improved GOS as its active pharmaceutical ingredient.
In addition, the Company agreed to purchase 350 kilos of Improved GOS for the sum of $250 per kilo for clinical supply of Improved
GOS instead of $2,000 per kilo as under the Existing Supply Agreement.
In
consideration for RSM entering into the Amended Supply Agreement, the Company will issue 100,000 shares of the Company’s
common stock, par value $0.001 per share (the “Shares”), to RSM. The Shares are to be issued within 90 days of the
effective date of the Amended Supply Agreement pursuant to a stock purchase agreement to be negotiated by the parties in good
faith. The stock purchase agreement is to include a lock-up agreement by RSM in favor of the Company pursuant to which RSM will
not be able to sell the Shares for a period ending on the earlier of (i) the public release by the Company of the final results
of its Phase 2b/3 clinical trial of RP-G28 and (ii) the filing of its Form 10-Q with the Securities and Exchange Commission for
the fiscal quarter in which the Company receives the results of its Phase 2b/3 clinical trial of RP-G28. The shares will be issued
to RSM upon the execution of the stock purchase agreement by
RSM.
The
agreement for 100,000 shares issuance to RSM has been recognized pursuant to ASC 815-10-15-9 as a fully prepaid forward sale contract
on the Company’s common stock. The fully prepaid forward sale contract is a hybrid instrument comprising (1) a debt host
instrument and (2) an embedded forward sale contract, requiring the Company to issue 100,000 shares of the Company’s common
stock for no further consideration. Fair value of these shares as of effective date of the agreement totaling $416,000 was recognized
in stockholders’ equity in the Condensed Balance Sheet as of September 30, 2015.
Leases
Until
September 30, 2015, the Company leased office and storage space for its headquarters in California pursuant to a two-year agreement
which called for a minimum monthly rent of approximately $5,000 and an annual increase of 3%. Rent expense, recognized on a straight-line
basis, was approximately $15,000 for each of the three months ended September 30, 2015 and 2014. The Company recognized approximately
$45,000 in each of the nine months ended September 30, 2015 and 2014 in rent expense. Rent expense is recorded in general and
administrative expenses in the Unaudited Condensed Statements of Operations.
On
July 9, 2015, the Company entered into a lease with Century Park, a California limited partnership, pursuant to which the Company
is leasing approximately 2,780 square feet of office space in Los Angeles, California for the Company’s headquarters. The
lease provides for a term of sixty-one (61) months, commencing on October 1, 2015. The Company will pay no rent for the first
month of the term and base rent of $9,174 per month for months 2 through 13 of the term, with increasing base rent for each twelve
month period thereafter under the term of the lease to a maximum of $10,325 per month for months 50 through 61. The base rent
payments do not include the Company’s proportionate share of any operating expenses, including real estate taxes. The Company
has the option to extend the term of the lease for one five-year term, provided that the rent would be subject to market adjustments
at the beginning of the renewal term. The Company will recognize rent expense in a straight-line basis over the lease term.
Legal
The
Company is not currently involved in any legal matters arising in the normal course of business. From time to time, the Company
could become involved in disputes and various litigation matters that arise in the normal course of business. These may include
disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically,
the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential
loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for
the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such
uncertainties, accruals are based on the best information available at the time. As additional information becomes available,
the Company reassesses the potential liability related to pending claims and litigation.
NOTE
6 — STOCKHOLDERS’ EQUITY (DEFICIT) AND PREFERRED STOCK SUBJECT TO REDEMPTION
Common
Stock
As
of December 31, 2014, the Company was authorized to issue 50,000,000 shares of common stock with a par value of $0.001 per share.
Effective June 17, 2015, the Company effected a 1-for-7.15 reverse stock split and all common share amounts and per share amounts
reflected in this Registration Statement Form S-1 have been adjusted to reflect that reverse stock split. The Company amended
and restated its Certificate of Incorporation on June 29, 2015 (“the Amended Certificate”) and reduced the authorized
shares of the Company’s common stock to 25,000,000 with a par value of $0.001 per share.
As
of September 30, 2015, the Company has a total of 7,792,433 shares of common stock issued and outstanding.
Preferred
Stock
The
Company’s Board of Directors is authorized, subject to any limitations prescribed by law, to provide for the issuance of
the authorized shares of preferred stock in series and to establish the number of shares to be included in each such series, and
to fix the designation, powers, preferences and rights of the shares of each such series and any qualifications, limitations or
restrictions thereon.
Pursuant
to the Amended Certificate, as of June 29, 2015, the Company was authorized to issue 5,000,000 shares of preferred stock, $0.001
par value per share. Prior to the Amended Certificate and as of December 31, 2014, the Company was authorized to issue 7,200,000
shares, 1,687,500 shares, 4,220,464 shares, 7,658,182 shares, and 4,500,000 shares of Series A-1, Series A-2, Series A-3, Series
B, and Series C preferred stock, respectively, with a par value of $0.001 per share.
Upon
the closing of the Company’s initial public offering, all outstanding shares of convertible preferred stock and preferred
stock subject to redemption were converted into an aggregate of 3,322,650 shares of common stock. The following provides material
terms and certain historical information regarding the Series A-1, Series A-2, Series A-3, Series B and Series C Preferred Stock
prior to their conversion to common stock:
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Redemption.
At any time after five years following the date of the initial issuance of the Series A-3, Series B, or Series C preferred
stock, as applicable, and at the option of the holders of a majority of the then outstanding shares of Series A-3, Series
B, and Series C preferred stock, voting together as a single class, the Company was required to redeem any outstanding shares
that have not been converted by paying cash in an amount per share equal to the liquidation preference of $0.62 and $1.30
for the Series A-3 and Series C preferred stock, respectively, and $1.19 per share, plus any accrued but unpaid dividends,
for the Series B preferred stock. Given the holders’ redemption option, the Series A-3, Series B, and Series C preferred
stock is classified as preferred stock subject to redemption in the accompanying unaudited Condensed Balance Sheets. |
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Dividends.
The holders of outstanding shares of preferred stock were entitled to receive dividends, when, as and if declared by the
Company’s Board of Directors. The annual dividend rate was $0.00556 per share for the Series A-1 preferred stock, $0.032
per share for the Series A-2 preferred stock, $0.04957 per share for the Series A-3 preferred stock, $0.09524 per share for
the Series B preferred stock, and $0.104 for Series C preferred stock (subject to adjustment). The right to receive dividends
on shares of Series B preferred stock was cumulative and the dividends accrue to holders of Series B preferred stock whether
or not dividends are declared or paid in a calendar year. Undeclared dividends in arrears for the Series B preferred stock
was approximately $2 million and $1.7 million as of June 29, 2015 and December 31, 2014, respectively. The right to receive
dividends on shares of Series A and Series C preferred stock was not cumulative and no right to such dividends accrued to
holders of Series A or Series C preferred stock. |
|
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Liquidations.
In the event of any liquidation, dissolution or winding up of the Company, either voluntary or involuntary, Series B and
Series C preferred stockholders receive an amount per share equal to the sum of the original purchase price of $1.19 plus
all cumulative but unpaid dividends for Series B, and $1.30 for Series C. If upon the liquidation, the available assets are
insufficient to permit payments to Series B and Series C holders, the entire assets legally available will be distributed
in a pro rata basis among the holders in proportion to the full amounts they would otherwise be entitled to receive. Upon
the completion of the distribution to the holders of the Series B and Series C preferred stock, the holders of the Series
A preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company
to the holders of all other capital stock by reason of their ownership of such stock, an amount per share equal to the sum
of the original issue price per share of $0.07, $0.40, and $0.62 for Series A-1, Series A-2, and Series A-3 preferred stock,
respectively, plus any accrued but unpaid dividends on the preferred stock. Any remaining assets are distributed pro rata
among the preferred and common shareholders. |
Stock
Transactions
Initial
Public Offering
On
June 29, 2015, the Company closed its initial public offering, selling 4,000,000 shares of the Company’s common stock at
an initial public offering price of $5.00 per share, for aggregate gross proceeds to the Company of $20 million. The Company paid
to the underwriters underwriting discounts and commissions of approximately $1.6 million in connection with the offering, and
approximately $1 million of other expenses in connection with the offering. Effective prior to the closing of the initial public
offering, the Company converted all of its outstanding shares of Series A-1, Series A-2, Series A-3, Series B, and Series C preferred
into an aggregate of 3,322,650 shares of the Company’s common stock.
Series
C Financing
In
December 2014, the Company issued an aggregate of 2,369,228 shares of Series C preferred stock and warrants to purchase an aggregate
of 331,358 shares of the Company’s common stock (the “Warrants”), for aggregate gross proceeds of $3,081,893
(the “Series C Financing”). All of these shares of Series C preferred stock were converted into 331,358 shares of
the Company’s common stock prior to the closing of the initial public offering. Each Warrant has a term of seven years and
provides for the holder to purchase one share of the Company’s common stock at a purchase price of $9.30 per share of common
stock. The Warrants are indexed to the Company’s own stock and classified within stockholders’ equity pursuant to
ASC 815-40. The gross proceeds were allocated to the Series C preferred stock and Warrants on a relative fair value basis, resulting
in a value of $7.83 for the Series C preferred stock. The allocation of proceeds to the Warrants creates a discount of $1.47 in
the initial carrying value of the Series C preferred stock, which was recognized as accretion, similar to preferred stock dividends,
over the five-year period prior to optional redemption by the holders.
In
connection with the Series C Financing, all of the 2014 Notes were converted into shares of Series C preferred stock and Warrants
as follows:
|
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$535,000
unpaid principal plus accrued interest of $18,342 on convertible notes converted into 567,529 shares of Series C preferred
stock, which was later converted into 79,374 shares of the Company’s common stock, and 79,374 Warrants |
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|
|
● |
$70,000
unpaid principal plus accrued interest of $537 on note payable extinguished and converted into 54,259 shares of Series C preferred
stock, which was later converted into 7,589 shares of the Company’s common stock and 7,589 Warrants |
Notes
with an unpaid principal balance of $535,000 were converted into shares of Series C preferred stock and warrants to purchase shares
of common stock at 75% of the price paid by other purchasers of the Series C Financing. The Company recognized additional interest
expense of $184,445 upon conversion, calculated as the fair value of incremental shares and warrants received by the holders compared
to converting the outstanding debt and accrued interest at 100% of the price paid by purchasers of the Series C Financing. The
note with an unpaid principal balance of $70,000 was exchanged for shares of Series C preferred stock and warrants to purchase
shares of common stock at a price per share equal to the price per share paid by purchasers of the Series C Financing. As such,
there was no gain recognized or loss incurred upon extinguishment of the note in 2014.
Prepaid
Forward Sale of Preferred Stock
On
November 30, 2010, the Company concurrently entered into a Research and Development Agreement & License (“R&D Agreement”)
and a Put and Call Option Agreement (“Option Agreement”) with two commonly controlled entities, Kolu Pohaku Technologies,
LLC (“KPT”) and Kolu Pohaku Management, LLC (“KPM”). The R&D Agreement was subsequently amended on
July 6, 2011, September 30, 2011, February 6, 2012 and November 4, 2013 to increase the funding received by the Company.
Research
and Development Agreement & License
The
R&D Agreement between the Company and KPM and KPT, a Qualified High Technology Business within the meaning of Hawaii Revised
Statutes, called for KPT to make a series of payments to the Company totaling $1,750,000 in exchange for the Company performing
research and development activities in Hawaii for the benefit of KPT (referred to herein as the KP Research). The KP Research
consisted of the initial phase of research, including the conduct of Phase II clinical trials in Hawaii for RP-G28. Pursuant to
the terms of the R&D Agreement, the Company maintained ownership of the results of the Company’s ongoing research related
to RP-G28, but KPT maintained ownership of the results of the KP Research. Inventions, developments and improvements arising out
of the KP Research were owned by KPT. Under the terms of the R&D Agreement, the Company would bear any costs involved in obtaining
patents for any inventions, developments or improvements resulting from the Research Project. In exchange for the irrevocable,
perpetual, exclusive, worldwide right and license to the results of the KP Research, as they are generated under this R&D
Agreement, the Company agreed to pay a quarterly royalty payment to KPT of $32,000 commencing March 31, 2015 and continuing through
December 31, 2035 or until such time as the KPM put or call option (as described below) was exercised. On March 26, 2015, the
Company exercised the KPM put option and issued 1,469,994 shares of Series B preferred stock to KPM, resulting in the full satisfaction
of the Company’s obligation to make royalty payments to KPT.
Option
Agreement
Pursuant
to the terms of the KPM Option Agreement, the Company had the right to put 1,469,994 shares of the Company’s Series B Preferred
Stock (“Series B”) to KPM and KPM had the option to call the same amount of shares of Series B from the Company at
any time after December 31, 2014. The number of shares was determined by dividing the $1,750,000 of payments made by KPT to the
Company under the R&D Agreement by the Series B original issue price of $1.19. Exercise of the put or call option would result
in full satisfaction of the Company’s obligation to make royalty payments to KPT under the R&D Agreement and KPT’s
right, title and interest in the research conducted pursuant to the R&D Agreement would become the property of the Company.
On March 26, 2015, the Company exercised its right to the KPM put option and issued 1,469,994 shares of Series B preferred stock
to KPM. Pursuant to the terms of the KPM Option Agreement, this resulted in the full satisfaction of the Company’s obligation
to make royalty payments to KPT under the R&D Agreement and also resulted in the termination of the R&D Agreement and
all of KPT’s right, title and interest in and to the KP Research, which rights now belong to the Company.
The
R&D Agreement and the put or call option have been recognized on a combined basis, pursuant to ASC 815-10-15-9, as a fully
prepaid forward sale contract on the Company’s Series B preferred stock. The fully prepaid forward sale contract is a hybrid
instrument comprising (1) a debt host instrument and (2) an embedded forward sale contract, requiring the Company to issue 1,469,994
shares of the Company’s Series B for no further consideration. Payments received by the Company, totaling $1,750,000, are
recognized as preferred stock subject to redemption in the Condensed Balance Sheet as of December 31, 2014. The Company converted
these shares into an aggregate of 205,593 shares of the Company’s common stock upon the closing of the IPO.
As
described in Note 6, in 2014, the Company issued seven-year warrants (the “Warrants”) to investors for the purchase
of 418,321 shares of the Company’s common stock at an exercise price of $9.30 per share.
The
Company analyzed the Warrants in accordance with ASC Topic 815 to determine whether the Warrants meet the definition of a derivative
and, if so, whether the Warrants meet the scope exception that provides for equity classification of derivative instruments issued
or held by the reporting entity that are both (1) indexed to its own stock and (2) classified in stockholders’ equity. The
Company concluded these Warrants should be classified as equity since they contain no provisions, which would require recognition
as a liability.
The
following represents a summary of the warrants outstanding at September 30, 2015 and changes during the period then ended:
| |
Weighted
Average | | |
Weighted
&Average | |
Warrants | |
Exercise
Price | | |
Exercise
Price | |
Outstanding
at December 31, 2014 | |
| 418,321 | | |
$ | 9.30 | |
| |
| - | | |
| - | |
Granted | |
| - | | |
| - | |
Outstanding
at September 30, 2015 | |
| 418,321 | | |
$ | 9.30 | |
Exercisable
at September 30, 2015 | |
| 418,321 | | |
$ | 9.30 | |
NOTE
8 — STOCK-BASED COMPENSATION
Terms
of the Company’s share-based compensation are governed by the Company’s 2015 Equity Incentive Plan, 2009 Stock Plan
and 2008 Stock Plan (collectively the “Plans”.) The Plans permit the Company to grant non-statutory stock options,
incentive stock options and other equity awards to the Company’s employees, outside directors and consultants; however,
incentive stock options may only be granted to the Company’s employees. Beginning June 29, 2015, no further awards may be
granted under the 2009 Stock Plan or 2008 Stock Plan. As of September 30, 2015, the aggregate number of shares of common stock
available for issuance under the 2015 Equity Incentive Plan is 206,448. However, to the extent awards under the 2008 Plan or 2009
Plan are forfeited or lapse unexercised or are settled in cash, the common stock subject to such awards will be available for
future issuance under the 2015 Equity Incentive Plan.
The
exercise price for an option issued under the Plans is determined by the Board of Directors, but will be (i) in the case of an
incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than
110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair
market value per share on the date of grant; and (ii) in the case of a nonstatutory stock option, no less than 100% of the fair
market value per share on the date of grant. The options awarded under the Plans shall vest as determined by the Board of Directors
but shall not exceed a ten-year period.
Options
Issued to Directors and Employees as Compensation
Pursuant
to the terms of the Plans, from inception to December 31, 2013, the Company issued options to purchase an aggregate of 206,172
shares to its executive officers and employees of the Company. The exercise prices of these option grants, as determined by the
Company’s Board of Directors, range from $0.79 to $1.27 per share, and a portion of these vest subject to certain performance
conditions described in Note 5. In addition, the Company granted additional non-qualified 10-year term options to its executive
officers to purchase an aggregate of 1,790,540 shares of the Company’s common stock in December 2014. As of December 31,
2014, an aggregate of 82,107 options were expired or exercised, and an aggregate of 1,914,605 options issued to executive officers
and employees remained outstanding.
During
the nine months ended September 30, 2015, no additional options were granted and an aggregate of 41,958 options to purchase the
Company’s common stock were automatically terminated due to certain performance conditions not being met. As of September
30, 2015, the Company has a total of 1,872,647 options issued to its executive officers and employees outstanding.
The
Company recognized stock based compensation expense for these services within general and administrative expense in the accompanying
Unaudited Condensed Statements of Operations of approximately $2.4 million and $2,500 for the nine months ended September 30,
2015 and 2014, respectively. As of September 30, 2015, there was approximately $2.4 million of total unrecognized compensation
cost related to non-vested share-based compensation arrangements. This cost is expected to be recognized over a weighted average
period of 1.6 years.
In
addition to annual cash compensation payable to the Company’s non-employee directors for their services on the Board and
its committees, the Board of Directors determined to award non-employee director an option to acquire 10,000 shares of the Company’s
common stock to vest 25% upon the first anniversary of the nonemployee director’s approximate date of joining the Board
of Directors with the remaining options vesting monthly in equal amounts over 36 months. As of September 30, 2015, no stock based
compensation had been granted to the nonemployee directors.
Options
Issued to Nonemployees for Services Received
From
inception to September 30, 2015, the Company issued options to consultants to the Company to purchase an aggregate of 106,573
shares of the Company’s common stock under the Plans. Of these, 73,985 options were forfeited or exercised, and 32,588 options
remain outstanding as of September 30, 2015. The exercise prices of the outstanding options, as determined by the Company’s
Board of Directors, range from $0.72 to $1.14 per share. These outstanding options, with the exception of an option to purchase
an aggregate of 7,271 shares granted to a consultant, vest 25% upon the first anniversary of the vesting commencement date with
the remaining options vesting monthly in equal amounts over 36 months. In March 2011, the Company granted an option to a consultant
to purchase an aggregate of 7,271 shares with an exercise price of $1.00 which vests 25% on the date of grant with the remaining
options vesting monthly in equal amounts over 36 months. The Company recognized stock based compensation expense for these services
of approximately $700 and $1,000 for the nine months ended September 30, 2015 and 2014, respectively, within research and development
expense in the accompanying Unaudited Condensed Statements of Operations.
Options
Valuation
The
Company calculates the fair value of stock-based compensation awards granted to employees and nonemployees using the Black-Scholes
option-pricing method. If the Company determines that other methods are more reasonable, or other methods for calculating these
assumptions are prescribed by regulators, the fair value calculated for the Company’s stock options could change significantly.
Higher volatility and longer expected lives would result in an increase to stock-based compensation expense to non-employees determined
at the date of grant.
Stock-based
compensation expense to non-employees affects the Company’s general and administrative expenses and research and development
expenses.
The
Black-Scholes option-pricing model requires the use of highly subjective and complex assumptions, which determine the fair value
of stock-based awards. The assumptions used in the Black-Scholes option-pricing method for the three months and nine months ended
September 30, 2015 and 2014 are set forth below:
| |
Three
months ended September 30,
| | |
Nine
months ended September 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
Expected
dividend yield | |
| (1 | ) | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
Expected
stock-price volatility | |
| (1 | ) | |
| 56.12%
- 64.24 | % | |
| 51.45%
- 67.08 | % | |
| 55.32%
- 64.24 | % |
Risk-free
interest rate | |
| (1 | ) | |
| 0.94%
- 2.58 | % | |
| 0.77%
- 2.07 | % | |
| 0.94%
- 3.04 | % |
Term of options | |
| (1 | ) | |
| 10 | | |
| 10 | | |
| 10 | |
Stock price | |
| (1 | ) | |
$ | 5.86 | | |
$ | 5.86 | | |
$ | 1.17
- $5.86 | |
(1)
During the three months ended September 30, 2015, the Company has no unvested options for non-employees and no new option was
granted to either employees and non-employees during the period.
|
● |
Expected
dividend yield. The expected dividend is assumed to be zero as the Company has never paid dividends and has no current
plans to pay any dividends on the Company’s common stock. |
|
|
|
|
● |
Expected
stock-price volatility. As the Company’s common stock only recently became publicly traded, the expected volatility
is derived from the average historical volatilities of publicly traded companies within the Company’s industry that
the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. |
|
|
|
|
● |
Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero
coupon U.S. Treasury notes with maturities approximately equal to the expected term. |
|
|
|
|
● |
Expected
term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s
historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because
of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by
the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life
of the options. |
In
addition to the assumptions used in the Black-Scholes option-pricing model, the Company also estimates a forfeiture rate to calculate
the stock-based compensation for the Company’s equity awards. The Company will continue to use judgment in evaluating the
expected volatility, expected terms and forfeiture rates utilized for the Company’s stock-based compensation calculations
on a prospective basis.
Stock-based
Compensation Summary Tables
Information
regarding the Company’s stock option grants to the Company’s employees and non-employees, along with the estimated
fair value per share of the underlying common stock, for stock options granted since 2005 is summarized as follows:
Grant
Date | |
Number
of Common Shares Underlying Options Granted | | |
Exercise
Price per Common Share | | |
Estimated
Fair Value per Share of
Common Stock | | |
Intrinsic
Value Option | |
2005 | |
| 58,321 | | |
$ | 0.07 | | |
$ | 1.79 | | |
$ | 1.72 | |
2009 | |
| 60,559 | | |
$ | 0.72
- $0.79 | | |
$ | 4.43 | | |
$ | 3.71
- $3.64 | |
2011 | |
| 33,846 | | |
$ | 1.00 | | |
$ | 1.00 | | |
$ | 0.00 | |
2012 | |
| 60,019 | | |
$ | 1.14 | | |
$ | 1.14 | | |
$ | 0.00 | |
2013 | |
| 100,000 | | |
$ | 1.14
- $1.30 | | |
$ | 1.14 | | |
$ | 0.00 | |
2014 | |
| 1,626,740 | | |
$ | 5.86
- $13.23 | | |
$ | 5.86 | | |
$ | 0.00 | |
The
following represents a summary of the options granted to employees and non-employees outstanding at September 30, 2015 and changes
during the period then ended:
| |
| | |
Weighted
Average | |
| |
Options | | |
Exercise
Price | |
Outstanding
at December 31, 2014 | |
| 1,952,516 | | |
$ | 7.022 | |
Granted | |
| - | | |
| - | |
Exercised/
Expired/ Forfeited | |
| (47,281 | ) | |
| (1.249 | ) |
Outstanding
at September 30, 2015 | |
| 1,905,235 | | |
$ | 7.165 | |
Exercisable
at September 30, 2015 | |
| 584,960 | | |
$ | 5.202 | |
Expected
to be vested | |
| 1,320,275 | | |
$ | 8.034 | |
NOTE
9 — RELATED PARTY TRANSACTIONS
A
director of the Company is a managing director of Javelin Venture Partners GP, LLC, the general partner of Javelin Venture Partners
GP, L.P., which held a significant investment in the Company’s Series A-2, Series A-3, Series B, and Series C preferred
stock that was converted to common stock prior to the Company’s initial public offering. Two directors of the Company have
acted as a managing director of Stonehenge Partners LLC, which held a significant investment in the Company’s Series A-1
preferred stock and also held investments in the Company’s Series A-2 and Series B preferred stock that was converted to
common stock prior to the Company’s initial public offering.
Prior
to and during his employment with the Company, Mr. Ira Ritter served as CEO of Andela Group Inc., (“Andela”) a company
he founded in 1987, which is involved in corporate management, strategic and financial consulting. The Company incurred no expenses
for services received from Andela during the three months and nine months ended September 30, 2015, and approximately $48,000
and $146,000, respectively, during the three months and nine months ended September 30, 2014, all of which were classified in
general and administrative expenses in the Unaudited Condensed Statements of Operations.
Other
than disclosed, the Company has not entered into or been a participant in any transaction in which a related party had or will
have a direct or indirect material interest.
1,577,699
Shares
Common Stock
![](http://www.sec.gov/Archives/edgar/data/1460702/000149315216006847/image_001.jpg)
PROSPECTUS
________, 2016
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution
The
following table sets forth the estimated costs and expenses to be incurred in connection with the issuance and distribution of
the securities registered under this Registration Statement. All the amounts shown are estimates except the SEC registration fee.
| |
Total | |
SEC
registration fee | |
$ | 299 | |
Printing
and engraving expenses | |
$ | 10,000 | |
Legal
fees and expenses | |
$ | 50,000 | |
Accounting
fees and expenses | |
$ | 25,000 | |
NASDAQ
listing fee | |
$ | 5,000 | |
Transfer
agent and registrar fees | |
$ | 5,000 | |
Miscellaneous
fees and expenses | |
$ | 4,701 | |
Total | |
$ | 100,000 | |
Item
14. Indemnification of Directors and Officers
Our
amended and restated certificate of incorporation provides that we shall indemnify, to the fullest extent authorized by the Delaware
General Corporation Law, each person who is involved in any litigation or other proceeding because such person is or was a director
or officer of Ritter Pharmaceuticals, Inc. or is or was serving as an officer or director of another entity at our request, against
all expense, loss or liability reasonably incurred or suffered in connection therewith. Our amended and restated certificate of
incorporation provides that the right to indemnification includes the right to be paid expenses incurred in defending any proceeding
in advance of its final disposition, provided, however, that such advance payment will only be made upon delivery to us of an
undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately determined that
such director is not entitled to indemnification. If we do not pay a proper claim for indemnification in full within 30 days after
we receive a written claim for such indemnification, our certificate of incorporation and our bylaws authorize the claimant to
bring an action against us and prescribe what constitutes a defense to such action.
Section
145 of the Delaware General Corporation Law permits a corporation to indemnify any director or officer of the corporation against
expenses (including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in
connection with any action, suit or proceeding brought by reason of the fact that such person is or was a director or officer
of the corporation, if such person acted in good faith and in a manner that he reasonably believed to be in, or not opposed to,
the best interests of the corporation, and, with respect to any criminal action or proceeding, if he or she had no reason to believe
his or her conduct was unlawful. In a derivative action, (i.e., one brought by or on behalf of the corporation), indemnification
may be provided only for expenses actually and reasonably incurred by any director or officer in connection with the defense or
settlement of such an action or suit if such person acted in good faith and in a manner that he or she reasonably believed to
be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be provided if such person
shall have been adjudged to be liable to the corporation, unless and only to the extent that the court in which the action or
suit was brought shall determine that the defendant is fairly and reasonably entitled to indemnity for such expenses despite such
adjudication of liability.
Pursuant
to Section 102(b)(7) of the Delaware General Corporation Law, our certificate of incorporation eliminates the liability of a director
to us or our stockholders for monetary damages for such a breach of fiduciary duty as a director, except for liabilities arising:
|
● |
from
any breach of the director’s duty of loyalty to us or our stockholders; |
|
|
|
|
● |
from
acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; |
|
|
|
|
● |
under
Section 174 of the Delaware General Corporation Law; or |
|
|
|
|
● |
from
any transaction from which the director derived an improper personal benefit. |
We
carry insurance policies insuring our directors and officers against certain liabilities that they may incur in their capacity
as directors and officers.
In
addition, we have entered into indemnification agreements with each of our current directors and executive officers. These agreements
require us to indemnify these individuals to the fullest extent permitted under Delaware law against liabilities that may arise
by reason of their service to us and to advance expenses incurred as a result of any proceeding against them as to which they
could be indemnified. We also intend to enter into indemnification agreements with our future directors and executive officers.
Item
15. Recent Sales of Unregistered Securities
In
the three years preceding the filing of this registration statement, we have issued the following securities that were not registered
under the Securities Act. The following issuances have been adjusted to reflect the 1-for-7.15 reverse stock split of our common
stock. Preferred share issuances referred to below are as of their date of issuance. The preferred stock described below converted
into shares of our common stock on a 7.15-for-1 basis prior to the closing of our initial public offering.
(a)
Issuances of Capital Stock
In
November 2013, we entered into a Series B Preferred Stock Purchase Agreement with certain investors raising approximately $500,000,
selling 419,995 shares of Series B preferred stock. Also in November 2013, we converted a total of approximately $135,000 in convertible
notes, including accrued interest of approximately $9,000, into 103,235 shares of Series B preferred stock.
On
December 4, 2014, we issued an aggregate of 1,149,397 shares of our Series C Preferred Stock and warrants to purchase an aggregate
of 160,754 shares of our common stock to certain investors, including Javelin and Javelin SPV, in the Initial Series C Closing
pursuant to the Series C Preferred Stock Purchase Agreement. The aggregate purchase price paid by the investors was approximately
$1.31 million (consisting of cash and cancellation of certain promissory notes issued in 2014, as described below).
On
December 8, 2014, we issued an aggregate of 1,833,927 shares of our Series C Preferred Stock and warrants to purchase an aggregate
of 256,493 shares of our common stock to Javelin SPV in our Second Series C Closing pursuant to the Series C Preferred Stock Purchase
Agreement. The aggregate purchase price paid by Javelin was approximately $2.39 million.
On
December 19, 2014, we issued an aggregate of 7,692 shares of our Series C Preferred Stock and warrants to purchase an aggregate
of 1,075 shares of our common stock to one investor in our Third Series C Closing pursuant to the Series C Preferred Stock Purchase
Agreement. The aggregate purchase price paid by the investor was $10,007.
As
consideration for Ricerche Sperimentali Montale SpA, or RSM, entering into Amendment No. 2 to the Clinical Supply and Cooperation
Agreement, on November 30, 2015, we issued 100,000 shares of common stock to RSM pursuant to a stock purchase agreement, dated
as of November 30, 2015.
On
December 18, 2015, we entered into the Common Stock Purchase Agreement with Aspire Capital Fund, LLC, or Aspire Capital, which
provides that, upon the terms and subject to the conditions and limitations set forth in the agreement, Aspire Capital is committed
to purchase up to an aggregate of $10.0 million shares of our common stock, or the Purchase Shares, over the 30-month term of
the agreement. Pursuant to the terms of this agreement, Aspire Capital purchased 500,000 shares of our common stock at $2.00 per
share and we issued 188,864 shares of our common stock to Aspire Capital in consideration for entering into the agreement. The
Purchase Shares may be sold by us to Aspire Capital on any business day we select in two ways: (i) through a regular purchase
of up to 100,000 shares at a known price based on the market price of our common stock prior to the time of each sale, and (ii)
through a VWAP purchase of a number of shares up to 30% of the volume traded on the purchase date at a price equal to the lesser
of the closing sale price or 97% of the volume weighted average price for such purchase date.
Except
with respect to the Aspire Capital transaction, no underwriters were used in the foregoing transactions. The securities described
above were issued and sold in reliance on the exemptions from registration provided by Section 4(a)(2) of the Securities Act and/or
Rule 506 of Regulation D promulgated under the Securities Act. Each of the purchasers in these transactions represented to us
in connection with its purchase that it was acquiring the securities for investment and not for distribution and that it could
bear the risks of the investment. Each purchaser received written disclosures that the securities had not been registered under
the Securities Act and that any resale must be made pursuant to a registration statement or an available exemption from registration.
All of the foregoing securities were deemed restricted securities for the purposes of the Securities Act, except for the securities
that have been issued to or will be issued to Aspire Capital, which are being registered for sale by Aspire Capital in this prospectus.
(b)
Promissory Notes
In
November 2013, we converted $37,500 of accounts payable into a note payable resulting from a compromise settlement with a vendor
to complete satisfaction of all rights, claims, causes of action, indebtedness, and assertions that the vendor may have against
us. The note payable had a term of one year and required payments of $3,000 per month. The note payable had no stated
interest rate and, due to the short-term nature of the note, we did not impute interest on the note. The outstanding balance of
the note was $31,500 as of December 31, 2013. This note payable was fully paid during 2014.
We
issued two subordinated convertible notes with principal amounts of $25,000 and $350,000 on May 23, 2014, an $80,000 principal
amount subordinated convertible note on September 8, 2014, and an $80,000 principal amount subordinated convertible note on October
20, 2014, which notes bore interest at a rate of 8% per annum until paid in full. Each of these notes was converted into shares
of Series C preferred stock in the Series C Financing.
In
addition, we issued a $70,000 principal amount unsecured promissory note on October 9, 2014. This note bore interest at a rate
of 5% per annum until paid in full. This note was converted into shares of Series C preferred stock in the Series C Financing.
No
underwriters were used in the foregoing transactions. The securities described above were issued and sold in reliance on the exemptions
from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated under the Securities
Act. Each of the purchasers in these transactions represented to us in connection with its purchase that it was acquiring the
securities for investment and not for distribution and that it could bear the risks of the investment. Each purchaser received
written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant
to a registration statement or an available exemption from registration. All of the foregoing securities were deemed restricted
securities for the purposes of the Securities Act.
(c)
Grants and Exercises of Stock Options
Since
December 1, 2011, we have granted stock options to purchase an aggregate of 1,786,759 shares of our common stock, with 62,116
of such stock options having an exercise price of $1.14 per share (of which 33,855 have forfeited as of December 31, 2014),
1,066,567 of such stock options having an exercise price of $5.86 per share, 97,902 of such stock options having an exercise
price of $1.27, 280,086 of such stock options having an exercise price of $9.29, and 280,086 of such stock options
having an exercise price of $13.22 per share to employees and non-employees pursuant to our stock plans.
As
described in the section above entitled “Outstanding Equity Awards at Fiscal Year-End,” we also granted an option
to Michael Step on December 2, 2014 for a number of shares of common stock as would, together with the 646,537 shares subject
to the option granted to Mr. Step on December 2, 2014, represent in the aggregate 7.5% of the shares of common stock deemed to
be outstanding on a fully-diluted basis as of the date that we raised in the aggregate a minimum of $15,000,000 in one
or more private and/or public offerings, or a Qualified Financing, after giving effect to (i) the issuance of the shares issued
in the Qualified Financing, (ii) the issuance of this option, and (iii) any adjustments. This option became exercisable upon the
closing of our initial public offering on June 29, 2015. Pursuant to the terms of the agreement, the option is exercisable for
a total of 163,799 shares of our common stock, which, together with the shares subject to an option granted to Mr. Step on December
2, 2014 to purchase 646,537 shares, represents 7.5% of the shares of common stock deemed to be outstanding at June 29, 2015 on
a fully-diluted basis, after giving effect to the number of shares subject to this option.
No
underwriters were used in the foregoing transactions. The securities were issued in reliance on the exemptions from registration
provided by Section 4(a)(2) of the Securities Act and/or Rule 701 promulgated under Section 3(b) of the Securities Act as a transaction
pursuant to a compensatory benefit plan or contract relating to compensation. Each purchaser received written disclosures that
the securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration statement
or an available exemption from registration. All of the foregoing securities were deemed restricted securities for the purposes
of the Securities Act.
(d)
Prepaid Forward Sale of Preferred Stock
On
November 30, 2010, we concurrently entered into a Research and Development Agreement & License, or the R&D Agreement,
and a Put and Call Option Agreement, or the KPM Option Agreement, with two commonly controlled entities, Kolu Pohaku Technologies,
LLC, or KPT, and Kolu Pohaku Management, LLC, or KPM. The agreement was subsequently amended on, July 6, 2011, September 30, 2011,
February 6, 2012 and November 4, 2013 to increase the funding received by us.
Pursuant
to the terms of the KPM Option Agreement, we had the right to put to KPM and KPM had the right to call from us 1,469,994 shares
of our Series B preferred stock at any time after December 31, 2014. The number of shares was determined by dividing the $1,750,000
of payments made by KPT to us under the R&D Agreement by the Series B preferred stock original issue price of $1.19
per share. On March 26, 2015, we exercised our right to put the KPM Option and issued 1,469,994 shares of Series B preferred stock
to KPM.
Item
16. Exhibits and Financial Statement Schedules
(a)
Exhibits
See
the Exhibit Index on the page immediately preceding the exhibits for a list of exhibits filed as part of this registration statement
on Form S-1, which Exhibit Index is incorporated herein by reference.
(b)
Financial Statement Schedules
Schedules
have been omitted because the information required to be set forth therein is not required or is shown either in the financial
statements or notes thereto.
Item
17. Undertakings
|
(a) |
The undersigned registrant
hereby undertakes: |
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(1) |
To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
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(i) |
To include
any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
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(ii) |
To reflect
in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in
the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration
statement; |
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(iii) |
To include
any material information with respect to the plan of distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement; |
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(2) |
That,
for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof. |
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(3) |
To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering. |
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(4) |
That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser: each prospectus filed pursuant
to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on
Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration
statement as of the date it is first used after effectiveness; provided, however , that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated
by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser
with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document immediately prior to such
date of first use. |
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(h) |
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling
persons of the registrant pursuant to the provisions described under Item 14 above, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the
registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
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SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the Registrant has duly caused this Amendment No.1 to the
Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of
Los Angeles, California, on the 19th day of January, 2016.
|
RITTER PHARMACEUTICALS, INC. |
|
By: |
/s/
Michael D. Step |
|
Name: |
Michael D.
Step |
|
Title: |
Chief Executive
Officer |
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Amendment No.1 to the Registration Statement has been
signed by the following persons in the capacities and on the dates indicated below .
Signature |
|
Title |
|
Date |
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|
|
|
/s/
Michael D. Step |
|
Chief
Executive Officer and Director |
|
January
19, 2016 |
Michael
D. Step |
|
(Principal
Executive Officer) |
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/s/
Ellen Mochizuki |
|
Vice
President Finance |
|
January
19, 2016 |
Ellen
Mochizuki |
|
(Principal
Financial and Accounting Officer) |
|
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|
|
/s/ Ira
E. Ritter |
|
Executive
Chairman, Chief Strategic Officer |
|
January
19, 2016 |
Ira
E. Ritter |
|
and
Director |
|
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|
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|
|
/s/ Andrew
J. Ritter |
|
President
and Director |
|
January
19, 2016 |
Andrew
J. Ritter |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
January
19, 2016 |
Noah
Doyle |
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* |
|
Director |
|
January
19, 2016 |
Matthew
W. Foehr |
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* |
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Director |
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January
19, 2016 |
Paul
V. Maier |
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* |
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Director |
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January
19, 2016 |
Gerald
T. Proehl |
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By: |
/s/
Andrew J. Ritter |
|
|
Andrew J. Ritter |
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|
Attorney-in-fact |
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EXHIBIT
INDEX
|
|
|
|
Incorporated
by Reference |
Exhibit
No. |
|
Description
|
|
Form |
|
File
No. |
|
Exhibit |
|
Filing
Date |
3.1 |
|
Amended
and Restated Certificate of Incorporation of Ritter Pharmaceuticals, Inc. |
|
8-K |
|
001-37428 |
|
3.1 |
|
7/1/2015 |
3.2 |
|
Amended
and Restated Bylaws of Ritter Pharmaceuticals, Inc. |
|
8-K |
|
001-37428 |
|
3.2 |
|
7/1/2015 |
4.1 |
|
Form
of Common Stock Certificate of Ritter Pharmaceuticals, Inc. |
|
S-1/A |
|
333-202924 |
|
4.1 |
|
5/22/2015 |
4.2 |
|
Amended
and Restated Investors’ Rights Agreement, dated as of November 17, 2010, by and among Ritter Pharmaceuticals, Inc. and
the persons and entities named therein |
|
S-1 |
|
333-202924 |
|
4.2 |
|
3/23/2015 |
4.3 |
|
Amendment
No. 1 to the Amended and Restated Investors’ Rights Agreement, dated as of January 13, 2011, by and among Ritter Pharmaceuticals,
Inc. and the persons and entities named therein |
|
S-1 |
|
333-202924 |
|
4.3 |
|
3/23/2015 |
4.4 |
|
Amendment
No. 2 to the Amended and Restated Investors’ Rights Agreement, dated as of February 6, 2012, by and among Ritter Pharmaceuticals,
Inc. and the persons and entities named therein |
|
S-1 |
|
333-202924 |
|
4.4 |
|
3/23/2015 |
4.5 |
|
Amendment
No. 3 to the Amended and Restated Investors’ Rights Agreement, dated as of December 4, 2014, by and among Ritter Pharmaceuticals,
Inc. and the persons and entities named therein |
|
S-1 |
|
333-202924 |
|
4.5 |
|
3/23/2015 |
4.6 |
|
Amendment
No. 4 to the Amended and Restated Investors’ Rights Agreement, by and among Ritter Pharmaceuticals, Inc. and the persons
and entities named therein |
|
S-1 |
|
333-208818 |
|
4.6 |
|
12/31/2015 |
4.7 |
|
Form
of Common Stock Purchase Warrant |
|
S-1 |
|
333-208818 |
|
4.7 |
|
12/31/2015 |
4.8 |
|
Form
of Representative’s Warrant Agreement |
|
S-1/A |
|
333-202924 |
|
4.7 |
|
5/8/2015 |
4.9 |
|
Registration
Rights Agreement, dated December 18, 2015, by and between Ritter Pharmaceuticals, Inc. and Aspire Capital Fund, LLC |
|
8-K |
|
001-37428 |
|
4.1 |
|
12/21/2015 |
5.1 |
|
Opinion
of Reed Smith LLP |
|
S-1 |
|
333-208818 |
|
5.1 |
|
12/31/2015 |
10.1 |
|
Office
Lease, dated June 25, 2013, by and between Douglas Emmett 1997, LLC and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.1 |
|
5/8/2015 |
10.2+ |
|
Offer
Letter, dated December 2, 2014, by and between Michael D. Step and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.2 |
|
5/8/2015 |
10.3+ |
|
Executive
Compensation Plan |
|
S-1 |
|
333-202924 |
|
10.3 |
|
5/8/2015 |
10.4+ |
|
Executive
Severance & Change in Control Agreement, dated October 1, 2014, by and between Ritter Pharmaceuticals, Inc. and Michael
D. Step |
|
S-1 |
|
333-202924 |
|
10.4 |
|
5/8/2015 |
10.5+ |
|
2008
Stock Plan |
|
S-8 |
|
333-207709 |
|
99.1 |
|
10/30/15 |
10.6+ |
|
2009
Stock Plan |
|
S-1 |
|
333-202924 |
|
10.6 |
|
3/23/2015 |
10.7+ |
|
2015
Equity Incentive Plan |
|
S-8 |
|
333-207709 |
|
99.3 |
|
10/30/15 |
10.8+ |
|
Form
of Notice of Grant of Stock Option under the 2015 Equity Incentive Plan |
|
S-8 |
|
333-207709 |
|
99.4 |
|
10/30/15 |
10.9+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Michael D. Step |
|
S-1 |
|
333-202924 |
|
10.8 |
|
5/8/2015 |
10.10+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Michael D. Step |
|
S-1 |
|
333-202924 |
|
10.9 |
|
5/8/2015 |
10.11+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Michael D. Step |
|
S-1 |
|
333-202924 |
|
10.10 |
|
5/8/2015 |
10.12+ |
|
Stock
Option Agreement, dated September 25, 2013, by and between Ritter Pharmaceuticals, Inc. and Andrew J. Ritter |
|
S-1 |
|
333-202924 |
|
10.11 |
|
5/8/2015 |
10.13+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Andrew J. Ritter |
|
S-1 |
|
333-202924 |
|
10.12 |
|
5/8/2015 |
10.14+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Andrew J. Ritter |
|
S-1 |
|
333-202924 |
|
10.13 |
|
5/8/2015 |
10.15+ |
|
Stock
Option Agreement, dated September 25, 2013, by and between Ritter Pharmaceuticals, Inc. and Ira E. Ritter |
|
S-1 |
|
333-202924 |
|
10.14 |
|
5/8/2015 |
10.16+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Ira E. Ritter |
|
S-1 |
|
333-202924 |
|
10.15 |
|
5/8/2015 |
10.17+ |
|
Stock
Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc. and Ira E. Ritter |
|
S-1 |
|
333-202924 |
|
10.16 |
|
5/8/2015 |
10.18 |
|
Research
and Development Agreement & License, dated November 30, 2010, by and among Kolu Pohaku Technologies, LLC, Kolu Pohaku
Management, LLC and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.17 |
|
5/8/2015 |
10.19 |
|
Amendment
No. 1 to Research and Development Agreement & License, dated July 6, 2011, by and among Kolu Pohaku Technologies, LLC,
Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.18 |
|
5/8/2015 |
10.20 |
|
Amendment
No. 2 to Research and Development Agreement & License, dated September 30, 2011, by and among Kolu Pohaku Technologies,
LLC, Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.19 |
|
5/8/2015 |
10.21 |
|
Amendment
No. 3 to Research and Development Agreement & License, dated February 6, 2012, by and among Kolu Pohaku Technologies,
LLC, Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.20 |
|
5/8/2015 |
10.22 |
|
Amendment
No. 4 to Research and Development Agreement & License, dated November 4, 2013, by and among Kolu Pohaku Technologies,
LLC, Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc. |
|
S-1 |
|
333-202924 |
|
10.21 |
|
5/8/2015 |
10.23 |
|
Put
and Call Option Agreement, dated November 30, 2010, by and between Kolu Pohaku Technologies, LLC and Ritter Pharmaceuticals,
Inc. |
|
S-1 |
|
333-202924 |
|
10.22 |
|
5/8/2015 |
10.24 |
|
Subordinated
Convertible Promissory Note to SJ Investment Company, LLC, dated May 23, 2014, in the principal amount of $25,000.00
|
|
S-1 |
|
333-202924 |
|
10.23 |
|
5/8/2015 |
10.24 |
|
Subordinated
Convertible Promissory Note to Javelin Venture Partners, L.P., dated May 23, 2014, in the principal amount of $350,000.00
|
|
S-1 |
|
333-202924 |
|
10.24 |
|
5/8/2015 |
10.26 |
|
Subordinated
Convertible Promissory Note to Javelin Venture Partners, L.P., dated September 8, 2014, in the principal amount of
$80,000.00 |
|
S-1 |
|
333-202924 |
|
10.25 |
|
5/8/2015 |
10.27 |
|
Unsecured
Promissory Note to Javelin Venture Partners, L.P., dated October 9, 2014, in the principal amount of $70,000.00 |
|
S-1 |
|
333-202924 |
|
10.26 |
|
5/8/2015 |
10.28 |
|
Subordinated
Convertible Promissory Note, dated October 20, 2014, in the principal amount of $80,000.00 |
|
S-1 |
|
333-202924 |
|
10.27 |
|
5/8/2015 |
10.29 |
|
Series
C Preferred Stock and Warrant Purchase Agreement, dated December 4, 2014, by and among Ritter Pharmaceuticals, Inc. and the
Investors named therein |
|
S-1 |
|
333-202924 |
|
10.28 |
|
5/8/2015 |
10.30+ |
|
Form
of Indemnification Agreement between Ritter Pharmaceuticals, Inc. and each of its directors and executive officers |
|
S-1/A |
|
333-202924 |
|
10.29 |
|
4/24/2015 |
10.31 |
|
Clinical
Supply and Operation Agreement, dated December 16, 2009, by and among Ritter Pharmaceuticals, Inc. and Ricerche Sperimentali
Montale SpA and Inalco SpA |
|
S-1/A |
|
333-202924 |
|
10.30 |
|
4/24/2015 |
10.32 |
|
Amendment
1 to the Clinical Supply and Cooperation Agreement, dated September 25, 2010, by and among Ritter Pharmaceuticals, Inc. and
Ricerche Sperimentali Montale SpA and Inalco SpA |
|
S-1/A |
|
333-202924 |
|
10.31 |
|
4/24/2015 |
10.33+ |
|
Offer
Letter, by and between Ritter Pharmaceuticals, Inc. and Andrew J. Ritter |
|
10-Q |
|
001-37428 |
|
10.1 |
|
8/12/2015 |
10.34+ |
|
Offer
Letter, by and between Ritter Pharmaceuticals, Inc. and Ira E. Ritter |
|
10-Q |
|
001-37428 |
|
10.2 |
|
8/12/2015 |
10.35+ |
|
Executive
Severance & Change in Control Agreement, by and between Ritter Pharmaceuticals, Inc. and Andrew J. Ritter |
|
10-Q |
|
001-37428 |
|
10.3 |
|
8/12/2015 |
10.36+ |
|
Executive
Severance & Change in Control Agreement, by and between Ritter Pharmaceuticals, Inc. and Ira E. Ritter |
|
10-Q |
|
001-37428 |
|
10.4 |
|
8/12/2015 |
10.37 |
|
Lease
Agreement, dated July 9, 2015, between the Company and Century Park |
|
10-Q |
|
001-37428 |
|
10.1 |
|
11/10/2015 |
10.38 |
|
Amendment
No. 2 to Clinical Supply and Cooperation Agreement, effective July 24, 2015, between Ritter Pharmaceuticals, Inc., Ricerche
Sperimentali Montale SpA, and Inalco SpA |
|
10-Q |
|
001-37428 |
|
10.2 |
|
11/10/2015 |
10.39+ |
|
Offer
Letter, dated August 14, 2015, by and between Ritter Pharmaceuticals, Inc. and Ellen Mochizuki |
|
10-Q |
|
001-37428 |
|
10.3 |
|
11/10/2015 |
10.40+ |
|
Letter
of Agreement, dated October 20, 2015 between Ritter Pharmaceuticals, Inc. and Chord Advisors, LLC |
|
10-Q |
|
001-37428 |
|
10.4 |
|
11/10/2015 |
10.41 |
|
Common
Stock Purchase Agreement, dated December 18, 2015, by and between Ritter Pharmaceuticals, Inc. and Aspire Capital Fund, LLC |
|
8-K |
|
001-37428 |
|
10.1 |
|
12/21/2015 |
10.42 |
|
Master
Services Agreement, effective December 29, 2015, by and between Covance Inc. and Ritter Pharmaceuticals , Inc. |
|
S-1 |
|
333-208818 |
|
10.42 |
|
12/30/2015 |
23.1* |
|
Consent
of Mayer Hoffman McCann P.C., independent registered public accounting firm |
|
|
|
|
|
|
|
|
23.2 |
|
Consent
of Reed Smith LLP (included in Exhibit 5.1) |
|
S-1 |
|
333-208818 |
|
5.1 |
|
12/30/2015 |
24.1 |
|
Power
of Attorney (included on applicable signature pages) |
|
S-1 |
|
333-208818 |
|
- |
|
12/30/2015 |
* Filed herewith.
+
Indicates management contract or compensatory plan or arrangement.
Exhibit
23.1
![](http://www.sec.gov/Archives/edgar/data/1460702/000149315216006847/image_002.jpg)
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
As
independent registered public accountants, we hereby consent to the use in this Amendment No.1 to the Registration
Statement on Form S-1 and related Prospectus of our report dated March 13, 2015 (except for the matters noted in Note 11, as to
which the date is April 24, 2015, and except for the effects of the stock split as described in Note 2 and Note 3, as to which
the date is June 19, 2015) relating to the financial statements of Ritter Pharmaceuticals, Inc, (which report includes an explanatory
paragraph relating to the uncertainty of the Company’s ability to continue as a going concern) and to the reference to us
under the caption “Experts” which is contained in this Prospectus.
/s/
Mayer Hoffman McCann P.C. |
|
Orange
County, California |
|
January 19, 2016 |
|
Ritter Pharmaceuticals (NASDAQ:RTTR)
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Ritter Pharmaceuticals (NASDAQ:RTTR)
過去 株価チャート
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