Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced its financial results for the second quarter ended
June 30, 2017.
Dave Gonyer, R.Ph., President and CEO, stated,
“Throughout the first half of the year, we worked diligently toward
initiation of our PK study to ensure that the design, which was
reviewed by FDA at a Type A meeting in March, was appropriate to
demonstrate comparative exposure to the listed drug, Reglan®
Tablets. In the second quarter, we announced that we re-engaged
Spaulding Clinical Research, LLC, the firm that completed our
successful thorough ECG study, for the comparative exposure PK
study. Today, we announced the initiation of the PK study marking
another milestone in our development path for Gimoti and moving us
closer to our planned 505(b)(2) NDA filing. In parallel with the PK
study, we have continued preparation of the NDA for submission as
quickly as possible following completion of the study. The NDA is
being prepared in partnership with Rho, a well-established Contract
Research Organization (CRO) that has worked on other successful
gastrointestinal NDA submissions in the recent past, and we are
leveraging their dedicated team to help prepare a successful NDA
for Gimoti. We expect to complete the analysis of the trial data
and announce results in the fourth quarter of 2017, followed by a
potential NDA submission by the end of this year or in early
2018.”
Mr. Gonyer continued, “As we prepare for the
remainder of the year, we believe that we have laid the necessary
groundwork to successfully bring Gimoti to potential approval. We
have a balance sheet which will allow us to complete the PK study
and submit our NDA. Our three meetings with FDA over the past year
have reaffirmed our path to submission for Gimoti, and we remain
confident that we will be able to introduce a much-needed
alternative treatment for patients suffering from diabetic
gastroparesis.”
Second Quarter 2017 Financial
Review
For the second quarter of 2017, net loss was
approximately $1.6 million, or $(0.11) per basic share, compared to
a net loss of approximately $3.0 million, or $(0.41) per share, for
the three-month period ended June 30, 2016. Research and
development expenses totaled approximately $2.0 million for the
three months ended June 30, 2017, compared to approximately $2.1
million for the three months ended June 30, 2016.
For the second quarter of 2017, general and
administrative expenses were approximately $872,000 compared to
approximately $803,000 for the second quarter of 2016.
Total operating expenses for the three months
ended June 30, 2017 and 2016 were approximately $2.9 million.
The net loss for the second quarter of 2017 was
partially offset by a gain of approximately $1.3 million due to the
change in the fair value of warrant liability. The warrant
liability is subject to remeasurement at each reporting period and
we recognize any change in the fair value of the warrant liability
in the statement of operations. We anticipate that the value of the
warrants could fluctuate from quarter to quarter and that such
fluctuation could have a material impact on our financial
statements from quarter to quarter and year to year.
As of June 30, 2017, our cash and cash
equivalents were approximately $12.6 million.
Conference Call and Webcast
Evoke will hold a conference call on Monday,
August 14, 2017 at 4:30 pm ET to discuss the results. Participants
should dial 1-877-407-0789 (United States) or 1-201-689-8562
(International) and mention Evoke Pharma. 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 be
archived on Evoke's website for one year. In addition, a telephonic
replay of the call will be available until August 21, 2017. The
replay can be accessed by dialing 1-844-512-2921 (United States) or
1-412-317-6671 (International) with confirmation code 13666527.
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 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," "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
plans for a successful 505(b)(2) NDA submission for Gimoti; the
timing of announcement of the results of the PK study and the
timing of the submission of the NDA to the FDA; Evoke’s belief that
it has laid the necessary groundwork for potential approval of
Gimoti; Evoke’s current resources being sufficient to allow Evoke
to complete the PK study and submit the NDA; and Evoke’s belief
that there is a large unmet need for an effective treatment for
diabetic gastroparesis. 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: risks
associated with successfully initiating, conducting and receiving
favorable results from the PK study; later developments with the
FDA that may be inconsistent with the already completed pre-NDA
meetings; 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 submit an NDA for Gimoti
or obtain regulatory approval for or successfully commercialize
Gimoti; risks associated with manufacturing new formulations of
Gimoti for use in the PK study; Evoke’s dependence on third parties
for the manufacture of Gimoti; Evoke’s dependence on Spaulding
Clinical Research to conduct the PK study; Evoke’s depending on
Rho, Inc. to assist with the NDA submission for Gimoti; Evoke may
require additional funding to complete the PK study and submit the
NDA, and will require substantial additional funding to
commercialize Gimoti, 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. |
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Condensed Balance Sheet |
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June 30,2017 |
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December 31,2016 |
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(Unaudited) |
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Assets |
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Current Assets: |
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Cash and
cash equivalents |
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$ |
12,556,280 |
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$ |
9,007,071 |
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Prepaid
expenses |
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587,932 |
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267,711 |
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Other
current assets |
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— |
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7,997 |
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Total current
assets |
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13,144,212 |
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9,282,779 |
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Other assets |
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11,551 |
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11,551 |
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Total assets |
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$ |
13,155,763 |
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$ |
9,294,330 |
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Liabilities and
stockholders' equity |
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Current
Liabilities: |
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Accounts
payable and accrued expenses |
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$ |
1,121,519 |
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$ |
478,223 |
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Accrued
compensation |
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757,492 |
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933,450 |
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Total current
liabilities |
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1,879,011 |
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1,411,673 |
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Warrant liability |
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4,506,763 |
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4,095,019 |
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Total liabilities |
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6,385,774 |
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5,506,692 |
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Stockholders'
equity: |
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Common
stock |
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1,539 |
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1,235 |
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Additional paid-in capital |
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72,255,601 |
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62,595,546 |
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Accumulated deficit |
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(65,487,151 |
) |
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(58,809,143 |
) |
Total stockholders'
equity |
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6,769,989 |
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3,787,638 |
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Total liabilities and
stockholders' equity |
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$ |
13,155,763 |
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$ |
9,294,330 |
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Evoke Pharma, Inc. |
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Condensed Statement of
Operations |
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(Unaudited) |
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Three Months EndedJune
30, |
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Six Months EndedJune
30 |
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2017 |
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2016 |
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2017 |
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2016 |
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Operating
expenses: |
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Research
and development |
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$ |
2,017,569 |
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$ |
2,095,149 |
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$ |
2,788,255 |
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$ |
4,110,225 |
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General
and administrative |
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871,979 |
|
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|
802,655 |
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2,081,549 |
|
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|
1,940,408 |
|
Total operating
expenses |
|
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2,889,548 |
|
|
|
2,897,804 |
|
|
|
4,869,804 |
|
|
|
6,050,633 |
|
Loss from
operations |
|
|
(2,889,548 |
) |
|
|
(2,897,804 |
) |
|
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(4,869,804 |
) |
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(6,050,633 |
) |
Other income
(expense): |
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Interest income
(expense), net |
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1,667 |
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(72,694 |
) |
|
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2,631 |
|
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(145,274 |
) |
Change in fair
value of warrant liability |
|
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1,261,912 |
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— |
|
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(1,810,835 |
) |
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— |
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Total other income
(expense), net |
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1,263,579 |
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(72,694 |
) |
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(1,808,204 |
) |
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(145,274 |
) |
Net loss |
|
$ |
(1,625,969 |
) |
|
$ |
(2,970,498 |
) |
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$ |
(6,678,008 |
) |
|
$ |
(6,195,907 |
) |
Net loss per
share of common stock, basic |
|
$ |
(0.11 |
) |
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$ |
(0.41 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.86 |
) |
Net loss per
share of common stock, diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.41 |
) |
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$ |
(0.55 |
) |
|
$ |
(0.86 |
) |
Weighted-average shares
used to compute basic net loss per share |
|
|
15,343,325 |
|
|
|
7,217,577 |
|
|
|
14,435,818 |
|
|
|
7,192,791 |
|
Weighted-average shares
used to computediluted net loss per share |
|
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15,421,057 |
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|
7,217,577 |
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|
14,474,684 |
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7,192,791 |
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Investor Contact:
The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
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