Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal diseases, today
announced its financial results for the first quarter ended March
31, 2017.
Dave Gonyer, R.Ph., President and CEO, stated,
“We started 2017 with a number of positive developments that bring
us closer to filing the 505(b)(2) NDA for Gimoti™. This includes
reaching agreement with FDA that a Human Factors (HF) Validation
Study, a requirement for drug/device combinations, is not needed
for Gimoti. Additionally, before the close of the quarter, we
completed a positive Type A meeting in which FDA confirmed the
acceptability of the design of our planned comparative exposure PK
study for Gimoti, as well as certain other chemistry, manufacturing
& controls (CMC) items associated with the proposed NDA. This
PK trial in healthy volunteers, which is designed to establish
comparative exposure of Gimoti to the listed drug, Reglan® Tablets,
will serve in part as the basis for a 505(b)(2) NDA submission for
Gimoti. We recently announced our partnership with Spaulding
Clinical Research to conduct the PK trial and expect to initiate
and complete the study in the second half of 2017. Finally, we
believe that the pre-NDA agreements with FDA further reduce
potential risks and save additional resources as we continue to
prepare the NDA for submission in late 2017 or early 2018.”
Mr. Gonyer continued, “From a financial
perspective, Evoke completed a capital raise in March, which
significantly enhanced our balance sheet and will allow us to
complete the PK trial and focus on the NDA filing. We believe this
capital infusion confirms our investors’ confidence in our strategy
and intent to seek approval for Gimoti as rapidly and efficiently
as possible. As we look forward to the rest of the year, we believe
there is a clear path for an NDA submission and we are working hard
to bring Gimoti to those patients suffering from diabetic
gastroparesis.”
First Quarter 2017 Financial
Review
For the first quarter of 2017, net loss was
approximately $5.1 million, or $(0.37) per share, compared to a net
loss of approximately $3.2 million, or $(0.45) per share, for the
three-month period ended March 31, 2016. The year-over-year
increase in net loss was primarily due to adjusting for the fair
value of the warrant liability at March 31, 2017, which resulted in
a significant non-cash expense.
Research and development expenses totaled
approximately $771,000 for the three months ended March 31, 2017,
compared to approximately $2.0 million for the three months ended
March 31, 2016. The decrease was due primarily to the expenses
related to our Phase 3 clinical trial which was still being
conducted during the three months ended March 31, 2016. This
trial was completed in the second quarter of 2016 and the analysis
of the trial data occurred during the second half of 2016.
For the first quarter of 2017, general and
administrative expenses were approximately $1.2 million compared
with approximately $1.1 million for the first quarter of 2016.
Total operating expenses for the three months
ended March 31, 2017 were approximately $2.0 million, compared to
total operating expenses of approximately $3.2 million for the
three months ended March 31, 2016.
Included in net loss for the first quarter of
2017 was an increase of net loss due to the change in the fair
value of the warrant liability of approximately $3.1 million.
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.
In March 2017, we completed a public offering of
approximately 2.8 million shares of common stock at $2.90 per
share, with gross proceeds of approximately $8.0 million, before
underwriting discounts and commissions and estimated offering
costs.
As of March 31, 2017, our cash and cash
equivalents were approximately $14.7 million.
Conference Call and Webcast
Evoke will hold a conference call on Monday, May
15, 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 May 22, 2017. The replay
can be accessed by dialing 1-844-512-2921 (United States) or
1-412-317-6671 (International) with confirmation code 13660963.
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," "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 clear
path forward with respect to submission of an 505(b) (2) NDA
submission for Gimoti based on a comparative exposure PK trial;
Evoke’s plans to initiate and complete the PK trial and submit the
NDA and potentially receive regulatory approval of Gimoti; and the
timing thereof, and Evoke’s expectation that it will not need to
raise additional capital to complete the comparative exposure PK
trial and submit the NDA for Gimoti. 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: risks associated with
successfully commencing and receiving favorable results from the
planned comparative exposure PK trial; later developments with the
FDA that may be inconsistent with the already completed pre- NDA
meetings, including inconsistent conclusions reflected in the
official meeting minutes from the FDA; 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 comparative
exposure PK trial; Evoke’s dependence on third parties for the
manufacture of Gimoti as well as the conduct of the PK trial; Evoke
may require additional funding to complete the PK trial 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; 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.
Evoke Pharma, Inc. |
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|
Condensed Balance Sheets |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
14,654,998 |
|
|
$ |
9,007,071 |
|
Prepaid
expenses |
|
|
171,524 |
|
|
|
267,711 |
|
Other
current assets |
|
|
— |
|
|
|
7,997 |
|
Total current
assets |
|
|
14,826,522 |
|
|
|
9,282,779 |
|
Other assets |
|
|
11,551 |
|
|
|
11,551 |
|
Total assets |
|
$ |
14,838,073 |
|
|
$ |
9,294,330 |
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
549,039 |
|
|
$ |
478,223 |
|
Accrued
compensation |
|
|
586,772 |
|
|
|
933,450 |
|
Total current
liabilities |
|
|
1,135,811 |
|
|
|
1,411,673 |
|
Warrant liability |
|
|
5,768,675 |
|
|
|
4,095,019 |
|
Total liabilities |
|
|
6,904,486 |
|
|
|
5,506,692 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
Common
stock |
|
|
1,539 |
|
|
|
1,235 |
|
Additional paid-in capital |
|
|
71,793,230 |
|
|
|
62,595,546 |
|
Accumulated deficit |
|
|
(63,861,182 |
) |
|
|
(58,809,143 |
) |
Total stockholders'
equity |
|
|
7,933,587 |
|
|
|
3,787,638 |
|
Total liabilities and
stockholders' equity |
|
$ |
14,838,073 |
|
|
$ |
9,294,330 |
|
Evoke Pharma, Inc. |
|
|
|
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Condensed Statements of Operations
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
Research
and development |
|
$ |
770,686 |
|
|
$ |
2,015,076 |
|
General
and administrative |
|
|
1,209,570 |
|
|
|
1,137,753 |
|
Total operating
expenses |
|
|
1,980,256 |
|
|
|
3,152,829 |
|
Loss from
operations |
|
|
(1,980,256 |
) |
|
|
(3,152,829 |
) |
Other expenses: |
|
|
|
|
Interest
income (expense), net |
|
|
964 |
|
|
|
(72,580 |
) |
Change in
fair value of warrant liability |
|
|
(3,072,747 |
) |
|
|
— |
|
Total other
expenses |
|
|
(3,071,783 |
) |
|
|
(72,580 |
) |
Net loss |
|
$ |
(5,052,039 |
) |
|
$ |
(3,225,409 |
) |
Net loss per share of
common stock, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
Weighted-average shares
used to compute basic and diluted net loss per share |
|
|
13,528,311 |
|
|
|
7,168,005 |
|
Investor Contact:
The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
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