Evoke Pharma Reports Third Quarter 2018 Results
November 13 2018 - 4:05PM
April 1, 2019 PDUFA date for Gimoti™ NDA
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, 2018.
“This quarter we continued to make progress with
Gimoti™, our novel nasal delivery of metoclopramide, to offer a new
path for the treatment of women suffering from
gastroparesis,” said, Dave Gonyer, R.Ph., President and CEO.
“The NDA review process with FDA is underway as well as
preparations for potential commercialization of Gimoti. We project
our cash runway to be through June 2019, past the Prescription User
Fee Act (PDUFA) target date of April 1, 2019.”
Third Quarter 2018 Financial
Review
For the third quarter of 2018, net loss was
approximately $1.5 million, or $(0.09) per share, compared to a net
loss of approximately $5.2 million, or $(0.34) per share, for the
three-month period ended September 30, 2017.
Research and development expenses totaled
approximately $625,000 for the three months ended September 30,
2018, compared to approximately $2.7 million for the same period in
2017. For the third quarter of 2018, general and administrative
expenses were approximately $897,000, compared to approximately
$984,000 for the third quarter of 2017.
Total operating expenses for the three months
ended September 30, 2018 were approximately $1.5 million, compared
to approximately $3.7 million for the same period in 2017.
As of September 30, 2018, our cash and cash
equivalents were approximately $6.6 million.
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 nasal spray
formulation of metoclopramide, for the relief of symptoms
associated with acute and recurrent diabetic gastroparesis in adult
women.
Diabetic gastroparesis is a GI disorder
affecting millions of patients worldwide, in which the stomach
takes too long to empty its contents resulting in serious digestive
system symptoms. The gastric delay caused by gastroparesis can
compromise absorption of orally administered medications.
Metoclopramide is currently available only in oral and injectable
formulations and is the only drug currently approved in the United
States to treat gastroparesis. 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," "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: the
potential timing of FDA action on the NDA for Gimoti; Evoke’s plans
for commercialization of Gimoti; Evoke’s projected cash runway; and
the potential of Gimoti to offer a new treatment option for women
suffering from 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: the potential for the FDA to delay the PDUFA target
action date due to the FDA's internal resource constraints or other
reasons; the FDA may disagree that the existing safety database and
efficacy data is sufficient to allow approval of the NDA, including
as a result of the potential review issues identified by the FDA in
the Day-74 Letter such as, among others, Cmax falling below the
bioequivalence range in the comparative exposure PK trial, the
proposed duration of use for Gimoti being shorter as compared to
the maximum approved dosing duration for the referenced listed
drug, Reglan Tablets, and the available safety database supporting
such duration, the adequacy of the proposed REMS included in the
NDA, and the existing data supporting a female-only indication; the
FDA may not agree with Evoke's interpretation of the results of
clinical trials of Gimoti; later developments with the FDA that may
be inconsistent with the already completed pre-NDA meetings; the
possibility of an advisory committee meeting related to the NDA;
the inherent risks of clinical development of Gimoti; the
possibility of the FDA failing to finally approve Evoke’s proposed
proprietary name through the NDA review process; Evoke is entirely
dependent on the success of Gimoti, and Evoke cannot be certain
that FDA will approve the NDA for Gimoti or that Evoke will
successfully commercialize Gimoti; Evoke will require substantial
additional funding to conduct any new trials required by the FDA,
and to conduct pre-commercialization activities and to
commercialize Gimoti, if approved, and may be unable to raise
capital when needed, including to fund ongoing operations; 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.Balance Sheet
|
September
30,2018 |
|
|
December 31,2017 |
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
6,567,918 |
|
|
$ |
7,679,267 |
|
Prepaid
expenses |
|
438,957 |
|
|
|
251,046 |
|
Total current
assets |
|
7,006,875 |
|
|
|
7,930,313 |
|
Other assets |
|
11,551 |
|
|
|
11,551 |
|
Total assets |
$ |
7,018,426 |
|
|
$ |
7,941,864 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
625,994 |
|
|
$ |
1,048,927 |
|
Accrued
compensation |
|
984,683 |
|
|
|
1,025,911 |
|
Total current
liabilities |
|
1,610,677 |
|
|
|
2,074,838 |
|
Warrant liability |
— |
|
|
|
3,701,277 |
|
Total liabilities |
|
1,610,677 |
|
|
|
5,776,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
|
Common
stock |
|
1,743 |
|
|
|
1,541 |
|
Additional paid-in capital |
|
82,250,109 |
|
|
|
73,202,863 |
|
Accumulated deficit |
|
(76,844,103 |
) |
|
|
(71,038,655 |
) |
Total stockholders'
equity |
|
5,407,749 |
|
|
|
2,165,749 |
|
Total liabilities and
stockholders' equity |
$ |
7,018,426 |
|
|
$ |
7,941,864 |
|
|
|
|
|
|
|
|
|
Evoke Pharma,
Inc.Statements of
Operations(Unaudited)
|
Three Months EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
625,497 |
|
|
$ |
2,717,698 |
|
|
$ |
3,399,654 |
|
|
$ |
5,505,953 |
|
General
and administrative |
|
897,060 |
|
|
|
984,047 |
|
|
|
2,846,611 |
|
|
|
3,065,595 |
|
Total operating
expenses |
|
1,522,557 |
|
|
|
3,701,745 |
|
|
|
6,246,265 |
|
|
|
8,571,548 |
|
Loss from
operations |
|
(1,522,557 |
) |
|
|
(3,701,745 |
) |
|
|
(6,246,265 |
) |
|
|
(8,571,548 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
3,089 |
|
|
|
2,822 |
|
|
|
7,425 |
|
|
|
5,452 |
|
Change in
fair value of warrant liability |
— |
|
|
|
(1,544,138 |
) |
|
|
433,392 |
|
|
|
(3,354,973 |
) |
Total other income
(expense) |
|
3,089 |
|
|
|
(1,541,316 |
) |
|
|
440,817 |
|
|
|
(3,349,521 |
) |
Net loss |
$ |
(1,519,468 |
) |
|
$ |
(5,243,061 |
) |
|
$ |
(5,805,448 |
) |
|
$ |
(11,921,069 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic |
$ |
(0.09 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, diluted |
$ |
(0.09 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.84 |
) |
Weighted-average shares
used to compute basic net loss per share |
|
17,129,649 |
|
|
|
15,351,295 |
|
|
|
16,327,385 |
|
|
|
14,740,977 |
|
Weighted-average shares
used to compute diluted net loss per share |
|
17,129,649 |
|
|
|
15,351,295 |
|
|
|
16,327,385 |
|
|
|
14,766,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:The Ruth GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
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