Evoke Pharma to Resubmit Gimoti™ NDA Based on FDA Meeting Minutes and Announces Second Quarter 2019 Financial Results
August 08 2019 - 5:30AM
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that following receipt of U.S. Food and Drug
Administration (FDA) minutes from a type A meeting held on July 25,
2019, the Company intends to resubmit its New Drug Application
(NDA) for Gimoti™ in the fourth quarter of 2019. The Company also
announced its financial results for the second quarter ended June
30, 2019.
The purpose of the type A meeting was to obtain
the Agency’s feedback and agreement on the Company’s plan to
address deficiencies cited in the April 2019 Complete Response
Letter (CRL) in support of a resubmission of the Gimoti NDA.
The focus of the discussion was on topics noted in the CRL,
including the root cause analysis of low drug exposure in the
comparative bioavailability study and additional product
quality/device quality control testing.
Based on FDA feedback and the meeting minutes,
the Company will include its root cause analysis and previously
collected patient use and experience information in its
resubmission package. The Company also agreed to provide an
analysis of pump performance characteristics of the nasal spray
devices used in the comparative bioavailability study and 3-month
stability data from commercial scale batches of Gimoti which the
Company initiated manufacturing in June 2019. FDA did not request
additional human clinical trials be completed for resubmission.
“We are very pleased with the outcome of our
meeting with FDA and appreciate their thoughtful approach in
considering the totality of the data from our previously submitted
NDA, along with a root cause analysis summary and additional
quality data that will be referenced in our planned resubmission,”
said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma,
Inc. “We now have the clarity required to resubmit our Gimoti NDA
in the fourth quarter of 2019, and we believe we have sufficient
funds to support our operations into the second quarter of
2020.”
Second Quarter 2019 Financial
Review
For the second quarter of 2019, net loss was
approximately $2.1 million, or $0.09 per share, compared to a net
loss of approximately $2.3 million, or $0.14 per share for the
second quarter of 2018.
Research and development expenses totaled
approximately $1.2 million for the second quarter of 2019, compared
to approximately $1.4 million for the second quarter of 2018.
Research and development expenses were primarily related to
responding to requests for additional information from FDA and
manufacturing registration batches of Gimoti.
For the second quarter of 2019, general and
administrative expenses were approximately $0.9 million compared to
approximately $0.9 million for the second quarter of 2018.
Total operating expenses for the second quarter
of 2019 were approximately $2.1 million, compared to total
operating expenses of approximately $2.3 million for the second
quarter of 2018.
As of June 30, 2019, the Company’s cash and cash
equivalents were approximately $7.4 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: Evoke’s
plan to resubmit the Gimoti NDA in the fourth quarter of 2019;
Evoke’s specific plans on the inclusion of certain analysis and
date in the resubmission; and Evoke’s belief that it can address
the approvability issues raised by the FDA in the CRL and during
the Type a meeting. 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: FDA
may disagree that the root cause analysis and additional patient
data will address the PK variability or droplet size distribution
issues raised by FDA; the stability data from the commercial scale
batches manufactured in June 2019 may not address the FDA’s
concerns or support approval of the NDA; later developments with
FDA that may be inconsistent with the already completed meetings,
and the risk that the resubmitted NDA may still not be accepted by
the FDA; FDA may not agree with Evoke’s interpretation of the
results of clinical trials of Gimoti; the inherent risks of
clinical development of Gimoti; Evoke may still incur significant
additional expenses prior to the Gimoti NDA resubmission which
could significantly shorten our projected cash runway; Evoke’s
reliance on a third party, Novos Growth Partners (NGP), for
critical aspects of the commercialization of Gimoti; Evoke’s
ability to timely secure a contract sale organization; Evoke could
face unexpected costs due to additional regulatory requests,
litigation or other events; 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 and NGP will successfully
commercialize Gimoti; Evoke may require substantial additional
funding, and may be unable to raise capital or obtain funds under
the working capital loan or line of credit 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.
Condensed Balance Sheets
|
|
June 30,2019 |
|
|
December 31,2018 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,440,079 |
|
|
$ |
5,319,004 |
|
Prepaid expenses |
|
|
109,739 |
|
|
|
329,218 |
|
Other current assets |
|
|
11,551 |
|
|
— |
|
Total current assets |
|
|
7,561,369 |
|
|
|
5,648,222 |
|
Operating lease right-of-use asset |
|
|
69,795 |
|
|
— |
|
Other assets |
|
— |
|
|
|
11,551 |
|
Total assets |
|
$ |
7,631,164 |
|
|
$ |
5,659,773 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
407,517 |
|
|
$ |
476,202 |
|
Accrued compensation |
|
|
807,706 |
|
|
|
1,158,251 |
|
Operating lease liability |
|
|
69,795 |
|
|
— |
|
Total current liabilities |
|
|
1,285,018 |
|
|
|
1,634,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
2,411 |
|
|
|
1,743 |
|
Additional paid-in capital |
|
|
89,027,832 |
|
|
|
82,628,312 |
|
Accumulated deficit |
|
|
(82,684,097 |
) |
|
|
(78,604,735 |
) |
Total stockholders' equity |
|
|
6,346,146 |
|
|
|
4,025,320 |
|
Total liabilities and stockholders' equity |
|
$ |
7,631,164 |
|
|
$ |
5,659,773 |
|
|
|
|
|
|
|
|
|
|
Evoke Pharma, Inc.
Condensed Statements of
Operations
(Unaudited)
|
|
Three Months EndedJune
30, |
|
Six Months EndedJune 30, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,205,599 |
|
|
$ |
1,388,791 |
|
|
$ |
1,952,481 |
|
|
$ |
2,774,157 |
|
General and administrative |
|
|
918,139 |
|
|
|
917,305 |
|
|
|
2,141,152 |
|
|
|
1,949,550 |
|
Total operating expenses |
|
|
2,123,738 |
|
|
|
2,306,096 |
|
|
|
4,093,633 |
|
|
|
4,723,707 |
|
Loss from operations |
|
|
(2,123,738 |
) |
|
|
(2,306,096 |
) |
|
|
(4,093,633 |
) |
|
|
(4,723,707 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
9,642 |
|
|
|
2,902 |
|
|
|
14,271 |
|
|
|
4,335 |
|
Gain from change in fair value of warrant liability |
|
— |
|
|
— |
|
|
— |
|
|
|
433,392 |
|
Total other income |
|
|
9,642 |
|
|
|
2,902 |
|
|
|
14,271 |
|
|
|
437,727 |
|
Net loss |
|
$ |
(2,114,096 |
) |
|
$ |
(2,303,194 |
) |
|
$ |
(4,079,362 |
) |
|
$ |
(4,285,980 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.09 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used
to compute basic and diluted net loss per share |
|
|
23,258,567 |
|
|
|
16,425,468 |
|
|
|
20,371,442 |
|
|
|
15,926,253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Investor Contact:The Ruth GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
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