Evoke Pharma, Inc. (Nasdaq:EVOK) (the “Company"), a specialty
pharmaceutical company focused on treatments for gastrointestinal
diseases, today announced its financial results for the second
quarter ended June 30, 2016.
Dave Gonyer, R.Ph., President and CEO, stated,
“Following the results of our recently concluded Phase 3 study of
Gimoti™, our nasally delivered metoclopramide product for the
treatment of diabetic gastroparesis in women, we continue to
analyze the incoming data to further understand the trial outcome.
While conducting our review, we are also developing potential
regulatory submission strategies based on our findings.
“Although this trial with Gimoti did not
demonstrate a statistically significant improvement over placebo
for the primary endpoint, it is important to remember that
metoclopramide, in oral and IV dose forms, is the only drug
approved by the FDA to treat symptoms associated with diabetic
gastroparesis. In previous pharmacokinetic and placebo controlled
clinical trials, we have demonstrated that dosing with
metoclopramide nasal spray achieves comparable blood levels in both
healthy volunteers and diabetic gastroparesis patients.
Additionally, in our Phase 2b study, Gimoti provided statistically
significant improvement in the symptoms of gastroparesis in female
subjects, and we will continue to work with the FDA to pursue a
path to approval of Gimoti.
“Importantly, we recently completed financings for
$14.5 million in gross proceeds to support the continued review and
development of potential clinical and regulatory strategies for
Gimoti. This represents a significant investment in Evoke, which we
believe demonstrates investor confidence in Gimoti’s potential to
benefit patients suffering from gastroparesis and helps position us
to explore potential options as we work to get Gimoti to market. We
appreciate the support of our shareholders and continue to believe
nasal delivery of metoclopramide is a clinically‑important
alternative to oral and injectable formulations in this symptomatic
population of diabetic gastroparesis patients.”
Second Quarter 2016 Financial
Review
For the second quarter of 2016, net loss was
approximately $3.0 million, or $(0.41) per share, compared to a net
loss of approximately $3.2 million, or $(0.52) per share, for the
quarter ended June 30, 2015. Research and development expenses were
approximately $2.1 million for the three-month period ended June
30, 2016, compared to approximately $2.2 million in the previous
interim year period. The decrease was due to higher outside
clinical trial costs incurred in 2015 offset by higher consultant
costs incurred during the second quarter of 2016.
General and administrative expenses for the second
quarter were approximately $803,000 versus approximately $976,000
for the three months ended June 30, 2015. The decrease was
due to costs incurred in 2015 associated with market research
activities.
For the second quarter of 2016, total operating
expenses were approximately $2.9 million, compared to total
operating expenses of approximately $3.2 million for the three
months ended June 30, 2015.
As of June 30, 2016, the Company's cash and cash
equivalents were approximately $4.1 million.
Conference Call and WebcastEvoke
will hold a conference call on, August 15, 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 13643126. 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 August 22, 2016. The
replay dial-in numbers are 1-877-870-5176 for domestic callers and
1-858-384-5517 for international callers. Please use event passcode
13643126.
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: Gimoti’s potential to benefit patients
suffering from gastroparesis; potential regulatory submission
strategies for Gimoti; Evoke's plans to conduct additional analysis
of the trial data; and the potential for regulatory approval and
commercialization of 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 risk 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; 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)
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Evoke Pharma, Inc. Condensed
Balance Sheets |
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June 30, 2016 |
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December 31, 2015 |
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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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$ |
4,129,051 |
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$ |
8,691,155 |
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Prepaid expenses |
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499,324 |
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833,276 |
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Other current assets |
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7,997 |
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— |
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Total current assets |
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4,636,372 |
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9,524,431 |
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Other assets |
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— |
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7,997 |
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Total assets |
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$ |
4,636,372 |
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$ |
9,532,428 |
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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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$ |
1,264,145 |
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$ |
927,606 |
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Accrued compensation |
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499,305 |
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760,782 |
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Current portion of long-term
debt |
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4,399,835 |
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146,052 |
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Total current liabilities |
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6,163,285 |
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1,834,440 |
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Long-term debt, net of current portion |
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— |
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4,233,059 |
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Total liabilities |
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6,163,285 |
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6,067,499 |
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Evoke Pharma, Inc.Condensed
Statements of Operations(Unaudited) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Operating
expenses: |
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Research and development |
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$ |
2,095,149 |
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$ |
2,188,138 |
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$ |
4,110,225 |
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$ |
4,608,099 |
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General and administrative |
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802,655 |
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976,418 |
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1,940,408 |
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2,001,679 |
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Total operating
expenses |
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2,897,804 |
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3,164,556 |
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6,050,633 |
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6,609,778 |
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Loss from
operations |
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(2,897,804 |
) |
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(3,164,556 |
) |
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(6,050,633 |
) |
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(6,609,778 |
) |
Other expense |
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(72,694 |
) |
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(76,607 |
) |
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(145,274 |
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(152,133 |
) |
Net loss |
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$ |
(2,970,498 |
) |
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$ |
(3,241,163 |
) |
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$ |
(6,195,907 |
) |
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$ |
(6,761,911 |
) |
Net loss per common
share, basic and diluted |
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$ |
(0.41 |
) |
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$ |
(0.52 |
) |
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$ |
(0.86 |
) |
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$ |
(1.10 |
) |
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Weighted-average shares
used to compute basic and diluted net loss per
share |
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7,217,577 |
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6,212,803 |
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7,192,791 |
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6,157,226 |
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Investor Contact:
The Ruth Group
David Burke
O: 646-536-7009
C: 917-618-2651
dburke@theruthgroup.com
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