Ritter Pharmaceuticals Reports Financial Results for the Three and Six Months Ended June 30, 2019 and Provides a Corporate Up...
2019年8月15日 - 6:11AM
Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter
Pharmaceuticals” or the “Company”), a developer of innovative
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 (“LI”), today
reported financial results for the three and six months ended June
30, 2019 and provided a corporate update.
Recent Highlights
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● |
Completed last-patient last-visit in the Phase 3 “Liberatus”
clinical trial for RP-G28 for LI and commenced a finalization stage
leading to data lock and topline data release, which is expected
early in Q4 2019. |
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|
● |
Hosted lactose intolerance market research call to discuss recent
findings demonstrating the unmet need for better lactose
intolerance treatments and interest from both patients and
physicians in the RP-G28 drug profile. |
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|
● |
Appointed esteemed gastroenterologist, Anthony Lembo, MD to Medical
Advisory Board. Dr. Lembo is the Director of the GI Motility and
Functional Bowel Disorder Center at Beth Israel Deaconess Medical
Center and Professor of Medicine at Harvard Medical School. |
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|
● |
Confirmed alignment with FDA on key elements of the Phase 3
“Liberatus” trial’s Statistical Analysis Plan, including the
primary endpoint, secondary endpoints and other critical
components |
“Our focus in Q2 2019 was to ensure completion
of all patient visits in our Phase 3 Liberatus clinical trial and
to expand on our understanding of the lactose intolerance market. I
am proud of our team for successfully completing these objectives,”
said Andrew J. Ritter, Chief Executive Officer of Ritter
Pharmaceuticals. “Our focus for the rest of 2019 will be on the
finalization of the Liberatus study and the reporting of topline
results in early Q4, followed by sharing detailed results more
broadly at a clinical conference.”
Financial Results for the Three and Six
Months Ended June 30, 2019
The Company’s net loss for the three and six
months ended June 30, 2019 was $2.8 million and $7.5 million, or
$0.31 per share and $0.88 per share, respectively, compared to $3.6
million and $5.6 million, or $0.71 per share and $1.12 per share,
for the same periods in 2018, respectively. Net loss for the three
and six months ended June 30, 2019, included non-cash, stock-based
compensation expense of $123,000 and $269,000, respectively,
compared to $178,000 and $391,000, for the same periods in 2018,
respectively. As of June 30, 2019, the Company had cash and cash
equivalents of approximately $4.4 million compared to $7.8 million
in cash and cash equivalents as of December 31, 2018.
The net decrease in cash and cash equivalents in
2019 was due to the Company’s use of cash to fund the Phase 3
Liberatus clinical trial. The decrease in net loss for the three
months ended June 30, 2019 and net loss per share for both the
three- and six-month periods in 2019 compared to 2018 was primarily
due to the winding down of development efforts as the Liberatus
clinical trial enters its finalization stage.
About Ritter
Pharmaceuticals
Ritter Pharmaceuticals, Inc.
(www.ritterpharma.com, @RitterPharma) develops innovative
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 worldwide. RP-G28 is in Phase 3 clinical development with
its first Phase 3 clinical trial, known as “Liberatus,” currently
in its finalization stage with top-line data expected in early Q4
2019. 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 Statements
This 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. Any statements
contained herein that do not describe historical facts, including
statements related to anticipated timing for the release of data
from the Phase 3 Liberatus clinical trial are forward-looking
statements. Forward-looking statements 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. Some of the factors that could affect
actual results are included in the periodic reports on Form 10-K
and Form 10-Q that we file with the Securities and Exchange
Commission. Ritter cautions readers not to place undue reliance on
any forward-looking statements, which speak only as of the date
they were made. The Company undertakes no obligation to update or
revise forward-looking statements, except as otherwise required by
law, whether as a result of new information, future events or
otherwise.
ContactsInvestor
Contact:JohnBeck 310-203-1000 john@ritterpharma.com
RITTER PHARMACEUTICALS,
INC.CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited)
|
|
For the Three Months EndedJune
30, |
|
|
For the Six Months EndedJune
30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,433,036 |
|
|
$ |
1,871,242 |
|
|
$ |
5,007,891 |
|
|
$ |
2,720,925 |
|
Patent costs |
|
|
69,944 |
|
|
|
48,263 |
|
|
|
118,569 |
|
|
|
111,351 |
|
General and administrative |
|
|
1,345,486 |
|
|
|
1,686,903 |
|
|
|
2,499,063 |
|
|
|
2,812,794 |
|
Total operating costs and expenses |
|
|
2,848,466 |
|
|
|
3,606,408 |
|
|
|
7,625,523 |
|
|
|
5,645,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(2,848,466 |
) |
|
|
(3,606,408 |
) |
|
|
(7,625,523 |
) |
|
|
(5,645,070 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
33,314 |
|
|
|
21,756 |
|
|
|
104,605 |
|
|
|
47,728 |
|
Total other income |
|
|
33,314 |
|
|
|
21,756 |
|
|
|
104,605 |
|
|
|
47,728 |
|
Net loss |
|
$ |
(2,815,152 |
) |
|
$ |
(3,584,652 |
) |
|
$ |
(7,520,918 |
) |
|
$ |
(5,597,342 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on debt securities |
|
|
(588 |
) |
|
|
― |
|
|
|
923 |
|
|
|
― |
|
Comprehensive loss |
|
|
(2,815,740 |
) |
|
|
(3,584,652 |
) |
|
|
(7,519,995 |
) |
|
|
(5,597,342 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.71 |
) |
|
$ |
(0.88 |
) |
|
$ |
(1.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding – basic and diluted |
|
|
9,042,331 |
|
|
|
5,064,805 |
|
|
|
8,551,851 |
|
|
|
5,005,116 |
|
RITTER PHARMACEUTICALS,
INC.BALANCE SHEETS
|
|
June 30, 2019 |
|
|
December 31, 2018 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,380,494 |
|
|
$ |
7,812,259 |
|
Accrued interest receivable |
|
|
3,438 |
|
|
|
54,456 |
|
Investments in marketable securities |
|
|
― |
|
|
|
6,988,780 |
|
Prepaid expenses44 |
|
|
442,287 |
|
|
|
421,522 |
|
Total current assets |
|
|
4,826,219 |
|
|
|
15,277,017 |
|
Other assets |
|
|
|
|
|
|
|
|
Right-of-use assets |
|
|
146,504 |
|
|
|
― |
|
Other assets |
|
|
22,725 |
|
|
|
22,725 |
|
Total other assets |
|
|
169,229 |
|
|
|
22,725 |
|
Property and equipment,
net |
|
|
18,742 |
|
|
|
20,160 |
|
Total
Assets |
|
$ |
5,014,190 |
|
|
$ |
15,319,902 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,428,750 |
|
|
$ |
4,512,316 |
|
Accrued expenses |
|
|
292,654 |
|
|
|
1,407,843 |
|
Lease liabilities |
|
|
116,413 |
|
|
|
― |
|
Other liabilities |
|
|
― |
|
|
|
13,359 |
|
Total current liabilities |
|
|
2,837,817 |
|
|
|
5,933,518 |
|
Lease liabilities,
non-current |
|
|
40,790 |
|
|
|
― |
|
Total
Liabilities |
|
|
2,878,607 |
|
|
|
5,933,518 |
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Series A preferred stock,
$0.001 par value; 9,500 shares authorized; 4,080 shares issued and
outstanding as of June 30, 2019 and December 31, 2018 |
|
|
2,289,324 |
|
|
|
2,289,324 |
|
Series B preferred stock,
$0.001 par value; 6,000 shares authorized; 3,000 and 5,608 shares
issued and outstanding as of June 30, 2019 and December 31, 2018,
respectively |
|
|
2,090,199 |
|
|
|
3,906,931 |
|
Series C preferred stock,
$0.001 par value; 1,880 shares authorized; 240 and 1,880 shares
issued and outstanding as of June 30, 2019 and December 31, 2018,
respectively |
|
|
240,000 |
|
|
|
1,880,000 |
|
Common stock, $0.001 par
value; 225,000,000 shares authorized, 9,042,330 and 6,036,562
shares issued and outstanding as of June 30, 2019 and December 31,
2018, respectively |
|
|
9,042 |
|
|
|
6,037 |
|
Additional paid-in
capital |
|
|
75,228,081 |
|
|
|
71,505,160 |
|
Accumulated other
comprehensive income (loss) |
|
|
― |
|
|
|
(923 |
) |
Accumulated deficit |
|
|
(77,721,063 |
) |
|
|
(70,200,145 |
) |
Total stockholders’ equity |
|
|
2,135,583 |
|
|
|
9,386,384 |
|
Total Liabilities and
Stockholders’ Equity |
|
$ |
5,014,190 |
|
|
$ |
15,319,902 |
|
Ritter Pharmaceuticals (NASDAQ:RTTR)
過去 株価チャート
から 6 2024 まで 7 2024
Ritter Pharmaceuticals (NASDAQ:RTTR)
過去 株価チャート
から 7 2023 まで 7 2024