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, 2017.
Dave Gonyer, R.Ph., President and CEO, stated,
“We would like to reiterate the incredibly important milestone we
achieved with the success of our comparative exposure PK trial,
which demonstrated that two separate doses of Gimoti met the
selection criteria with similar systemic exposure to that of the
reference listed drug, Reglan Tablets. We believe the trial
results, which were in line with our expectations and consistent
with our prior discussions with FDA, mark the final clinical
milestone needed to complete our NDA submission package for Gimoti.
We remain confident that Gimoti holds significant potential to
bring a new treatment option to those suffering from acute and
recurrent diabetic gastroparesis."
Mr. Gonyer continued, “As we prepare to submit
our 505(b)(2) NDA to FDA in the first quarter of 2018, we have
effectively managed our resources to provide us the cash runway
past NDA submission and through June 2018. This extension from our
prior estimate is primarily due to projected cost savings related
to the management of our pre-commercialization activities. We are
careful stewards of our financial resources and have continued to
prudently manage our expenses and will continue to do so as we move
toward our NDA submission and a potential approval.”
Third Quarter 2017 Financial
Review
For the third quarter of 2017, net loss was
approximately $5.2 million, or $(0.34) per share, compared to a net
loss of approximately $3.0 million, or $(0.29) per share, for the
three-month period ended September 30, 2016.
Research and development expenses totaled
approximately $2.7 million for the three months ended September 30,
2017, compared to approximately $1.3 million for the three months
ended September 30, 2016.
For the third quarter of 2017, general and
administrative expenses were approximately $984,000, compared to
approximately $830,000 for the third quarter of 2016.
Total operating expenses for the three months
ended September 30, 2017 were approximately $3.7 million, compared
to approximately $2.2 million for the same period in 2016.
Included in net loss for the third quarter of
2017 was approximately $1.5 million of non-cash expense incurred
due to the change in the fair value of the 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 September 30, 2017, our cash and cash
equivalents were approximately $10.4 million.
Conference Call and Webcast
Evoke will hold a conference call on Tuesday,
November 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 November 21, 2017. The
replay can be accessed by dialing 1-844-512-2921 (United States) or
1-412-317-6671 (International) with confirmation code 13672618.
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 adults with diabetes mellitus. Diabetic
gastroparesis is a GI disorder afflicting millions of sufferers
worldwide, in which stomach emptying is unpredictable and
associated 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 spray 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
beliefs about the PK study data, including that the PK study was
successful and represents the final clinical milestone needed to
complete the Gimoti NDA submission package; the timing of the
submission of the Gimoti NDA to FDA; potential to receive
regulatory approval of Gimoti; and that Evoke’s current cash will
be sufficient to fund operations through June 2018. 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 topline data Evoke has
reported from the PK study is based on preliminary analysis of key
data, and such data may change following a more comprehensive
review of the data related to the PK study and such topline data
may not accurately reflect the complete results of the study, and
FDA may not agree with Evoke's interpretation of such results,
including risks associated with Cmax falling below the
bioequivalence range; 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; risks that FDA may require additional efficacy or
safety studies prior to submission or approval of the NDA; 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; Evoke’s
dependence on third parties for the manufacture of Gimoti as well
as the completion of the analysis of the PK trial data; Evoke may
require additional funding to 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.
(Financial Statements to Follow)
Evoke Pharma, Inc. |
Condensed Balance Sheets |
|
|
|
September
30,2017 |
|
December
31,2016 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
10,412,968 |
|
|
$ |
9,007,071 |
|
Prepaid
expenses |
|
|
334,728 |
|
|
|
267,711 |
|
Other
current assets |
|
— |
|
|
|
7,997 |
|
Total current
assets |
|
|
10,747,696 |
|
|
|
9,282,779 |
|
Other assets |
|
|
11,551 |
|
|
|
11,551 |
|
Total assets |
|
$ |
10,759,247 |
|
|
$ |
9,294,330 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
1,720,816 |
|
|
$ |
478,223 |
|
Accrued
compensation |
|
|
927,843 |
|
|
|
933,450 |
|
Total current
liabilities |
|
|
2,648,659 |
|
|
|
1,411,673 |
|
Warrant liability |
|
|
6,050,901 |
|
|
|
4,095,019 |
|
Total liabilities |
|
|
8,699,560 |
|
|
|
5,506,692 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
|
|
Common
stock |
|
|
1,541 |
|
|
|
1,235 |
|
Additional paid-in capital |
|
|
72,788,358 |
|
|
|
62,595,546 |
|
Accumulated deficit |
|
|
(70,730,212 |
) |
|
|
(58,809,143 |
) |
Total stockholders'
equity |
|
|
2,059,687 |
|
|
|
3,787,638 |
|
Total liabilities and
stockholders' equity |
|
$ |
10,759,247 |
|
|
$ |
9,294,330 |
|
|
|
|
|
|
|
|
|
|
|
Evoke Pharma, Inc. |
Condensed Statement of
Operations |
(Unaudited) |
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
2,717,698 |
|
|
$ |
1,339,343 |
|
|
$ |
5,505,953 |
|
|
$ |
5,449,568 |
|
General
and administrative |
|
|
984,047 |
|
|
|
830,092 |
|
|
|
3,065,595 |
|
|
|
2,770,500 |
|
Total operating
expenses |
|
|
3,701,745 |
|
|
|
2,169,435 |
|
|
|
8,571,548 |
|
|
|
8,220,068 |
|
Loss from
operations |
|
|
(3,701,745 |
) |
|
|
(2,169,435 |
) |
|
|
(8,571,548 |
) |
|
|
(8,220,068 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
(expense), net |
|
|
2,822 |
|
|
|
(123,209 |
) |
|
|
5,452 |
|
|
|
(268,483 |
) |
Financing costs
related to warrant liability |
|
— |
|
|
|
(533,692 |
) |
|
— |
|
|
|
(533,692 |
) |
Change in fair
value of warrant liability |
|
|
(1,544,138 |
) |
|
|
(198,945 |
) |
|
|
(3,354,973 |
) |
|
|
(198,945 |
) |
Total other expense,
net |
|
|
(1,541,316 |
) |
|
|
(855,846 |
) |
|
|
(3,349,521 |
) |
|
|
(1,001,120 |
) |
Net loss |
|
$ |
(5,243,061 |
) |
|
$ |
(3,025,281 |
) |
|
$ |
(11,921,069 |
) |
|
$ |
(9,221,188 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic |
|
$ |
(0.34 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.89 |
) |
|
$ |
(1.11 |
) |
Weighted-average shares
used to compute basic net loss per share |
|
|
15,351,295 |
|
|
|
10,614,692 |
|
|
|
14,740,977 |
|
|
|
8,341,750 |
|
Weighted-average shares
used to compute diluted net loss per share |
|
|
15,351,295 |
|
|
|
10,614,692 |
|
|
|
14,766,853 |
|
|
|
8,341,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:The Ruth GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Apr 2023 to Apr 2024