Ritter Pharmaceuticals Reports Financial Results for the Three and Six Months Ended June 30, 2018 and Recent Progress
2018年8月15日 - 5:15AM
Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter
Pharmaceuticals” or the “Company”), a developer of novel
therapeutic products that modulate the gut microbiome to treat
gastrointestinal diseases with an initial focus on the development
of RP-G28, a drug candidate with the potential to be the first
FDA-approved treatment for lactose intolerance, today reports
financial results for the three and six months ended June 30, 2018.
Recent Corporate Highlights
- Initiated first pivotal Phase 3 trial (“Liberatus”) of RP-G28
for the treatment of lactose intolerance
- Presented Phase 2b clinical trial data on RP-G28 at Digestive
Diseases Week 2018
- Andrew J. Ritter named chief executive officer
- John W. Beck appointed as chief financial officer
“In the second quarter, we accomplished
several key milestones including, most importantly, commencement of
our first Phase 3 pivotal clinical trial for RP-G28 in the
treatment of lactose intolerance,” said Andrew J. Ritter, chief
executive officer of Ritter Pharmaceuticals. “With encouraging
results from our Phase 2b trial for RP-G28, we retained many key
protocol design components from our prior trials, and developed
enhanced controls based on lessons learned from those trials and
incorporated guidance and recommendations from our End-of-Phase 2
meeting with the FDA to enhance the design of our Phase 3
program. As a result, we are optimistic about the prospects
for our Phase 3 clinical trial and the potential for RP-G28 to
become the first FDA-approved treatment for lactose
intolerance. Meanwhile, we continue to focus on the clinical
and regulatory advancement of RP-G28 and its eventual
commercialization, including our development of a more robust
strategic commercialization plan and pricing and reimbursement
analysis. In addition, we have begun to explore additional
indications for RP-G28 in order to expand and enhance our product
pipeline.”
Corporate Priorities for Second Half of
2018 include:
- Continue to enroll Liberatus study participants and closely
monitor the clinical sites in our Phase 3 clinical trial of
RP-G28
- Conduct a panel discussion with leading GI experts Bill
Sandborn, M.D. & Bill Chey, M.D. to cover emerging trends
in Gastroenterology and the need for new LI treatments
- Present additional Phase 2b microbiome data at the American
College of Gastroenterology Conference 2018
- Explore additional indications for RP-G28
Financial Results
The Company's net loss for the three and six
months ended June 30, 2018 was $3.6
million and $5.6 million, or $0.71 per share
and $1.12 per share, respectively, compared to $2.0
million and $3.6 million, or $1.41 per share
and $2.84 per share, for the same periods in 2017,
respectively. Net loss for the three and six months ended June
30, 2018, included non-cash, stock-based compensation expense
of $178,000 and $391,000, respectively, compared
to $249,000 and $543,000, for the same periods in
2017, respectively. As of June 30, 2018, the Company had cash
and cash equivalents of approximately $16.3 million.
About Ritter
PharmaceuticalsRitter Pharmaceuticals, Inc.
(www.RitterPharma.com, @RitterPharma) develops novel therapeutic
products that modulate the gut microbiome to treat gastrointestinal
diseases. The Company’s lead product candidate, RP-G28, has the
potential to become the first FDA-approved treatment for lactose
intolerance, a condition that affects millions of people worldwide.
RP-G28 is currently in Phase 3 clinical development. The Company is
further exploring the therapeutic potential that gut microbiome
changes may have on treating/preventing a variety of diseases
including: gastrointestinal diseases, cancer, metabolic, and liver
disease.
Forward-Looking StatementsThis
press release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that express the current beliefs and expectations of Ritter
Pharmaceuticals’ management, including statements regarding its
Phase 3 pivotal clinical trial for RP-G28 in the treatment of
lactose intolerance and other research and development initiatives
of the Company. Any statements contained herein that do not
describe historical facts are forward-looking statements that are
subject to risks and uncertainties that could cause actual results,
performance and achievements to differ materially from those
discussed in such forward-looking statements. Factors that could
affect our actual results are included in the Company’s most
recently filed periodic reports on Form 10-K and Form 10-Q and
subsequent filings that we make with the Securities and Exchange
Commission. These forward-looking statements are made only as of
the date hereof, and the Company undertakes no obligation to update
or revise the forward-looking statements, except as otherwise
required by law, whether as a result of new information, future
events or otherwise.
RITTER PHARMACEUTICALS,
INC.
CONDENSED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
For the Three Months Ended June
30, |
|
|
For the Six Months Ended June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Operating costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
1,871,242 |
|
|
$ |
774,476 |
|
|
$ |
2,720,925 |
|
|
$ |
1,206,630 |
|
Patent
costs |
|
|
48,263 |
|
|
|
50,661 |
|
|
|
111,351 |
|
|
|
128,363 |
|
General
and administrative |
|
|
1,686,903 |
|
|
|
1,144,220 |
|
|
|
2,812,794 |
|
|
|
2,315,545 |
|
Total
operating costs and expenses |
|
|
3,606,408 |
|
|
|
1,969,357 |
|
|
|
5,645,070 |
|
|
|
3,650,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(3,606,408 |
) |
|
|
(1,969,357 |
) |
|
|
(5,645,070 |
) |
|
|
(3,650,538 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
21,756 |
|
|
|
6,333 |
|
|
|
47,728 |
|
|
|
14,279 |
|
Total
other income |
|
|
21,756 |
|
|
|
6,333 |
|
|
|
47,728 |
|
|
|
14,279 |
|
Net
loss |
|
$ |
(3,584,652 |
) |
|
$ |
(1,963,024 |
) |
|
$ |
(5,597,342 |
) |
|
$ |
(3,636,259 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share – basic and diluted |
|
$ |
(0.71 |
) |
|
$ |
(1.41 |
) |
|
$ |
(1.12 |
) |
|
$ |
(2.84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding – basic and diluted |
|
|
5,064,805 |
|
|
|
1,395,330 |
|
|
|
5,005,116 |
|
|
|
1,278,625 |
|
RITTER PHARMACEUTICALS, INC.
CONDENSED BALANCE
SHEETS
|
|
June 30, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
16,254,455 |
|
|
$ |
22,631,971 |
|
Prepaid
expenses |
|
|
538,537 |
|
|
|
167,400 |
|
Total
current assets |
|
|
16,792,992 |
|
|
|
22,799,371 |
|
Other assets |
|
|
10,326 |
|
|
|
10,326 |
|
Property and equipment,
net |
|
|
23,087 |
|
|
|
23,873 |
|
Total
Assets |
|
$ |
16,826,405 |
|
|
$ |
22,833,570 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,361,268 |
|
|
$ |
2,237,579 |
|
Accrued
expenses |
|
|
534,222 |
|
|
|
454,252 |
|
Other
liabilities |
|
|
14,850 |
|
|
|
15,757 |
|
Total
current liabilities |
|
|
1,910,340 |
|
|
|
2,707,588 |
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.001
par value; 15,000,000 shares authorized, 7,560 and 9,140 shares
issued and outstanding as of June 30, 2018 and December 31, 2017,
respectively |
|
|
4,241,983 |
|
|
|
5,128,536 |
|
Common stock, $0.001
par value; 225,000,000 shares authorized, 5,334,639 and 4,940,652
shares issued and outstanding as of as of June 30, 2018 and
December 31, 2017, respectively |
|
|
5,335 |
|
|
|
4,941 |
|
Additional paid-in
capital |
|
|
69,597,523 |
|
|
|
68,323,939 |
|
Accumulated
deficit |
|
|
(58,928,776 |
) |
|
|
(53,331,434 |
) |
Total
stockholders’ equity |
|
|
14,916,065 |
|
|
|
20,125,982 |
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
16,826,405 |
|
|
$ |
22,833,570 |
|
Contacts
John Beck
310-203-1000
John@ritterpharma.com
Ritter Pharmaceuticals (NASDAQ:RTTR)
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