Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced its financial results for the third quarter ended
September 30, 2016.
Dave Gonyer, R.Ph., President and CEO, stated,
“The third quarter was a very active time for Evoke. After
receiving results from our Phase 3 clinical trial of Gimoti™ for
the relief of symptoms associated with acute and recurrent diabetic
gastroparesis in women, we began extensive data analysis to better
understand the outcome. We also completed a pre-New Drug
Application (NDA) meeting with the U.S. Food and Drug
Administration (FDA) related to various regulatory, chemistry,
manufacturing, and control (CMC), and non-clinical requirements in
connection with the Company’s potential Gimoti NDA submission.
Based on the review, discussion, and minutes received, it was
determined that the available data would be sufficient for
submission of that portion of an NDA utilizing the 505(b)(2)
pathway, with acceptance of the final NDA subject to their review
of the complete package. We consider this non-clinical pre-NDA
meeting a positive discussion based on these areas of development
which will serve as a precursor to a future meeting to discuss the
clinical portion of the NDA submission.”
Mr. Gonyer continued, “While our Phase 3 trial
did not meet its primary endpoint, there was a wealth of
affirmative information gained from this study and our Phase 2b
trial, as well as data from over 35 years of patients using the
oral and IV formulations of metoclopramide for the relief of
symptoms associated with gastroparesis, particularly nausea and
vomiting, all of which we believe will be important for our next
meeting with the FDA. As we continue to explore the options for
Gimoti, we have a strong balance sheet to support our efforts
following two financings during the quarter. We look forward to our
continued discussions with the FDA and are hopeful about the future
for Gimoti and its potential to provide women suffering from
diabetic gastroparesis with a needed non-oral therapeutic
option.”
Third Quarter 2016 Financial
Review
For the third quarter of 2016, net loss was
approximately $3.0 million, or $(0.29) per share, compared to a net
loss of approximately $2.7 million or $(0.42) per share, for the
three month period ended September 30, 2015.
Research and development expenses totaled
approximately $1.3 million for the three months ended September 30,
2016, compared to approximately $1.8 million for the three months
ended September 30, 2015.
For the third quarter of 2016, general and
administrative expenses were approximately $830,000 compared with
approximately $820,000 for the third quarter of 2015.
Total operating expenses for the three months
ended September 30, 2016 were approximately $2.2 million, compared
to total operating expenses of approximately $2.7 million for the
three months ended September 30, 2015.
As of September 30, 2016, the Company's cash and
cash equivalents were approximately $10.4 million.
Conference Call and Webcast
Evoke will hold a conference call on November
9th, 2016, at 4:30 p.m. ET to discuss the results. The dial-in
numbers are 1-877-407-0789 for domestic callers and 1-201-689-8562
for international callers. The conference ID number for both is
13648936. A live webcast of the conference call will also be
available on the investor relations page of the Company's corporate
website at www.EvokePharma.com.
After the live webcast, the event will remain
archived on Evoke’s website for one year. In addition, a telephonic
replay of the call will be available until November 16, 2016. The
replay dial-in numbers are 1-844-512-2921 for domestic callers and
1-412-317-6671 for international callers. Please use event passcode
13648936.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company
focused primarily on the development of drugs to treat GI disorders
and diseases. The Company is developing Gimoti, a metoclopramide
nasal spray for the relief of symptoms associated with acute and
recurrent gastroparesis in women with diabetes mellitus. Diabetic
gastroparesis is a GI disorder afflicting millions of sufferers
worldwide, in which the stomach takes too long to empty its
contents resulting in serious digestive system symptoms.
Metoclopramide is the only product currently approved in the United
States to treat gastroparesis, and is currently available only in
oral and intravenous forms. Gimoti is a novel formulation of this
drug, designed to provide systemic delivery of metoclopramide
through nasal administration. Visit www.EvokePharma.com for
more information.
Safe Harbor Statement
Evoke cautions you that statements included in
this press release that are not a description of historical facts
are forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as "may," "will,"
"should," , or expect," "plan," "anticipate," "could," "intend,"
"target," "project," "contemplates," "believes," "estimates,"
"predicts," "potential" or "continue" or the negatives of these
terms or other similar expressions. These statements are based on
the company's current beliefs and expectations. These
forward-looking statements include statements regarding: a future
meeting with the FDA to discuss the clinical portion of an NDA
submission; the potential for NDA submission, regulatory approval
and commercialization of Gimoti; and Gimoti’s potential to benefit
women suffering from diabetic gastroparesis;. The inclusion of
forward-looking statements should not be regarded as a
representation by Evoke that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Evoke's
business, including, without limitation: additional analyses of
data from the Phase 3 trial may produce negative or inconclusive
results, or may be inconsistent with previously announced topline
results; later developments with the FDA that may be inconsistent
with the already completed pre-NDA meeting; the inherent risks of
clinical development of Gimoti; Evoke is entirely dependent on the
success of Gimoti, and Evoke cannot be certain that it will be able
to conduct additional trials of Gimoti or obtain regulatory
approval for or successfully commercialize Gimoti; Evoke will
require substantial additional funding to continue to develop and
commercialize Gimoti, and may be unable to raise capital when
needed, including to fund ongoing operations; Evoke may not be able
to successfully commercialize Gimoti, if approved, as a
result of risks associated with market acceptance, coverage
and reimbursement and competing products; and other risks detailed
in Evoke's prior press releases and in the periodic reports it
files with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof, and Evoke
undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
(Financial Statements to follow)
|
|
Evoke Pharma, Inc. |
|
Condensed Balance Sheets |
|
|
|
|
|
September
30,2016 |
|
|
December 31,2015 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,379,882 |
|
|
$ |
8,691,155 |
|
Prepaid expenses |
|
|
425,246 |
|
|
|
833,276 |
|
Other current assets |
|
|
7,997 |
|
|
— |
|
Total current assets |
|
|
10,813,125 |
|
|
|
9,524,431 |
|
Other assets |
|
— |
|
|
|
7,997 |
|
Total assets |
|
$ |
10,813,125 |
|
|
$ |
9,532,428 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
498,134 |
|
|
$ |
927,606 |
|
Accrued compensation |
|
|
513,509 |
|
|
|
760,782 |
|
Current portion of long-term
debt |
|
— |
|
|
|
146,052 |
|
Total current liabilities |
|
|
1,011,643 |
|
|
|
1,834,440 |
|
Warrant liability |
|
|
5,098,404 |
|
|
— |
|
Long-term debt, net of current portion |
|
— |
|
|
|
4,233,059 |
|
Total liabilities |
|
|
6,110,047 |
|
|
|
6,067,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
1,235 |
|
|
|
720 |
|
Additional paid-in capital |
|
|
61,983,643 |
|
|
|
51,524,821 |
|
Accumulated deficit |
|
|
(57,281,800 |
) |
|
|
(48,060,612 |
) |
Total stockholders' equity |
|
|
4,703,078 |
|
|
|
3,464,929 |
|
Total liabilities and stockholders' equity |
|
$ |
10,813,125 |
|
|
$ |
9,532,428 |
|
|
|
|
|
|
|
|
|
|
|
|
Evoke Pharma, Inc. |
|
Condensed Statements of
Operations |
|
(Unaudited) |
|
|
|
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months EndedSeptember
30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,339,343 |
|
|
$ |
1,837,743 |
|
|
$ |
5,449,568 |
|
|
$ |
6,445,842 |
|
General and administrative |
|
|
830,092 |
|
|
|
819,703 |
|
|
|
2,770,500 |
|
|
|
2,821,382 |
|
Total operating
expenses |
|
|
2,169,435 |
|
|
|
2,657,446 |
|
|
|
8,220,068 |
|
|
|
9,267,224 |
|
Loss from
operations |
|
|
(2,169,435 |
) |
|
|
(2,657,446 |
) |
|
|
(8,220,068 |
) |
|
|
(9,267,224 |
) |
Other expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(123,209 |
) |
|
|
(77,954 |
) |
|
|
(268,483 |
) |
|
|
(230,087 |
) |
Financing costs related to warrant
liability |
|
|
(533,692 |
) |
|
— |
|
|
|
(533,692 |
) |
|
— |
|
Change in fair value of warrant
liability |
|
|
(198,945 |
) |
|
— |
|
|
|
(198,945 |
) |
|
— |
|
Total other
expense |
|
|
(855,846 |
) |
|
|
(77,954 |
) |
|
|
(1,001,120 |
) |
|
|
(230,087 |
) |
Net loss |
|
$ |
(3,025,281 |
) |
|
$ |
(2,735,400 |
) |
|
$ |
(9,221,188 |
) |
|
$ |
(9,497,311 |
) |
Net loss per common
share, basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.11 |
) |
|
$ |
(1.51 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
used to compute basic and diluted net loss per share |
|
|
10,614,692 |
|
|
|
6,494,845 |
|
|
|
8,341,750 |
|
|
|
6,271,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:
The Ruth Group
David Burke
Tel: 646-536-7009
dburke@theruthgroup.com
Media Contact:
The Ruth Group
Kirsten Thomas
Tel: 646-536-7014
kthomas@theruthgroup.com
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