Ritter Pharmaceuticals Reports Financial Results for the Three and Nine Months Ended September 30, 2019 and Provides Business...
November 13 2019 - 7:35PM
Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter
Pharmaceuticals” or the “Company”), a developer of therapeutic
products that modulate the gut microbiome to treat gastrointestinal
diseases, today reported recent business developments and financial
results for the three and nine months ended September 30, 2019.
Recent Developments
- In September 2019, the Company
announced that its Phase 3 clinical trial of RP-G28 for lactose
intolerance (LI), known as “Liberatus,” failed to demonstrate
statistical significance in its pre-specified primary and secondary
endpoints. Following a more in-depth review of the data, the
Company believes that while there was significant treatment benefit
to patients (39% of patients in the trial reported a meaningful
treatment benefit), the trial failed to demonstrate statistical
significance due, in part, to a high placebo response.
- The Company continues to believe that it has a number of viable
routes forward based on RP-G28’s portfolio of clinical and
microbiome data:
- LI continues to be a large and
underserved market and RP-G28 has demonstrated value as a treatment
for LI. The Company is currently reviewing its lactose intolerance
program, including its protocol design and endpoints to determine
whether there is a supportable clinical path forward. The Company
is also evaluating the consumer healthcare market as an
alternative, lower barrier and quicker route to market, given the
fact that RP-G28’s underlining starting material is generally
regarded as safe (GRAS) and based on the safety profile
demonstrated by RP-G28 in its clinical program to date.
- Given the beneficial shifts in
microbiome populations observed with RP-G28 treatment in clinical
studies, the Company continues to explore the therapeutic potential
of RP-G28 as an adjunctive or single therapeutic in other
indications, such as irritable bowel syndrome and inflammatory
bowel disease, which are also characterized by microbiome
dysbiosis.
- As announced in early October, the
Company has retained Alliance Global Partners (A.G.P.) as financial
advisor to explore and evaluate strategic alternatives to enhance
shareholder value. Alternatives may include an acquisition, merger,
reverse merger, other business combination, sale of assets,
licensing or other strategic transactions.
“We continue to believe there is significant
value in our late-stage clinical asset, RP-G28, and backed by our
resilient development team, we believe we have a number of viable
options,” said Andrew J. Ritter, Chief Executive Officer of Ritter
Pharmaceuticals. “We are committed to diligently managing our
resources as we assess all strategies to create value for our
shareholders.”
Financial Results for the Three and Nine
Months Ended September 30, 2019
The Company’s net loss for the three and nine
months ended September 30, 2019 was $2.2 million and $9.8 million,
or $0.23 per share and $1.09 per share, respectively, compared to
$4.7 million and $10.3 million, or $0.86 per share and $2.00 per
share, for the same periods in 2018, respectively. Net loss for the
three and nine months ended September 30, 2019, included non-cash,
stock-based compensation expense of $95,000 and $364,000,
respectively, compared to $171,000 and $562,000, for the same
periods in 2018, respectively. As of September 30, 2019, the
Company had cash and cash equivalents of approximately $2.0 million
compared to $14.8 million in cash, cash equivalents and
investment in marketable securities as of December 31, 2018.
The net decrease in cash and cash equivalents in
2019 was due to our use of cash to fund the Liberatus clinical
trial. The decrease in net loss for the three months ended
September 30, 2019 and net loss per share for both the three and
nine-month periods in 2019 compared to 2018, was primarily due to
the winding down of development efforts as the Liberatus clinical
trial entered its finalization stage.
The Company has significantly reduced its cash
burn moving forward, including reducing executive management and
board compensation and non-essential operating expenses to extend
its runway while keeping its core team and expertise intact.
About Ritter
PharmaceuticalsRitter Pharmaceuticals, Inc.
(www.RitterPharma.com, @RitterPharma) develops innovative
therapeutic products that modulate the gut microbiome to treat
gastrointestinal diseases. The Company is 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. Any statements contained herein that
do not describe historical facts, including statements related to
potential future RP-G28 development activities and potential
strategic transactions 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 are filed 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:John Beck 310-203-1000
john@ritterpharma.com
RITTER PHARMACEUTICALS,
INC.CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited)
|
|
For the Three Months EndedSeptember
30, |
|
|
For the Nine Months EndedSeptember
30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,036,689 |
|
|
$ |
3,459,681 |
|
|
$ |
6,044,580 |
|
|
$ |
6,180,607 |
|
Patent costs |
|
|
20,867 |
|
|
|
59,068 |
|
|
|
139,436 |
|
|
|
170,418 |
|
General and administrative |
|
|
1,122,825 |
|
|
|
1,144,750 |
|
|
|
3,621,888 |
|
|
|
3,957,545 |
|
Total operating costs and expenses |
|
|
2,180,381 |
|
|
|
4,663,499 |
|
|
|
9,805,904 |
|
|
|
10,308,570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(2,180,381 |
) |
|
|
(4,663,499 |
) |
|
|
(9,805,904 |
) |
|
|
(10,308,570 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
13,172 |
|
|
|
17,237 |
|
|
|
117,777 |
|
|
|
64,965 |
|
Total other income |
|
|
13,172 |
|
|
|
17,237 |
|
|
|
117,777 |
|
|
|
64,965 |
|
Net loss |
|
$ |
(2,167,209 |
) |
|
$ |
(4,646,262 |
) |
|
$ |
(9,688,127 |
) |
|
$ |
(10,243,605 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on debt securities |
|
|
― |
|
|
|
― |
|
|
|
923 |
|
|
|
― |
|
Comprehensive loss |
|
|
(2,167,209 |
) |
|
|
(4,646,262 |
) |
|
|
(9,687,204 |
) |
|
|
(10,243,605 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.86 |
) |
|
$ |
(1.09 |
) |
|
$ |
(2.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding – basic and diluted |
|
|
9,507,636 |
|
|
|
5,373,769 |
|
|
|
8,873,947 |
|
|
|
5,129,351 |
|
RITTER PHARMACEUTICALS,
INC.CONDENSED BALANCE SHEETS
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,957,395 |
|
|
$ |
7,812,259 |
|
Accrued interest receivable |
|
|
1,469 |
|
|
|
54,456 |
|
Investments in marketable securities |
|
|
― |
|
|
|
6,988,780 |
|
Prepaid expenses |
|
|
771,199 |
|
|
|
421,522 |
|
Total current assets |
|
|
2,730,063 |
|
|
|
15,277,017 |
|
Other assets |
|
|
|
|
|
|
|
|
Right-of-use assets |
|
|
119,978 |
|
|
|
― |
|
Other assets |
|
|
32,725 |
|
|
|
22,725 |
|
Total other assets |
|
|
152,703 |
|
|
|
22,725 |
|
Property and equipment,
net |
|
|
17,199 |
|
|
|
20,160 |
|
Total
Assets |
|
$ |
2,899,965 |
|
|
$ |
15,319,902 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,566,485 |
|
|
$ |
4,512,316 |
|
Accrued expenses |
|
|
141,222 |
|
|
|
1,407,843 |
|
Lease liabilities |
|
|
119,074 |
|
|
|
― |
|
Other liabilities |
|
|
― |
|
|
|
13,359 |
|
Total current liabilities |
|
|
2,826,781 |
|
|
|
5,933,518 |
|
Lease liabilities,
non-current |
|
|
10,274 |
|
|
|
― |
|
Total
Liabilities |
|
|
2,837,055 |
|
|
|
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 September 30, 2019 and December 31, 2018 |
|
|
2,289,324 |
|
|
|
2,289,324 |
|
Series B preferred stock,
$0.001 par value; 6,000 shares authorized; 1,850 and 5,608 shares
issued and outstanding as of September 30, 2019 and December 31,
2018, respectively |
|
|
1,288,956 |
|
|
|
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 September 30, 2019 and December 31,
2018, respectively |
|
|
240,000 |
|
|
|
1,880,000 |
|
Common stock, $0.001 par
value; 225,000,000 shares authorized, 9,926,956 and 6,036,562
shares issued and outstanding as of September 30, 2019 and December
31, 2018, respectively |
|
|
9,927 |
|
|
|
6,037 |
|
Additional paid-in
capital |
|
|
76,122,975 |
|
|
|
71,505,160 |
|
Accumulated other
comprehensive loss |
|
|
― |
|
|
|
(923 |
) |
Accumulated deficit |
|
|
(79,888,272 |
) |
|
|
(70,200,145 |
) |
Total stockholders’ equity |
|
|
62,910 |
|
|
|
9,386,384 |
|
Total Liabilities and
Stockholders’ Equity |
|
$ |
2,899,965 |
|
|
$ |
15,319,902 |
|
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