Item 8.01Other Events.
On January 27, 2020, Evoke Pharma, Inc. (the "Company") announced that the
United States Patent and Trademark Office (USPTO) issued a Notice of Allowance
for the Gimoti™ trademark.
Gimoti is Evoke's nasal spray product candidate for the relief of symptoms in
adult women with acute and recurrent diabetic gastroparesis. The U.S. Food and
Drug Administration (FDA) is currently reviewing the New Drug Application (NDA)
for Gimoti and has set a target goal date under the Prescription Drug User Fee
Act (PDUFA) of June 19, 2020.
Safe Harbor Statement
The Company cautions you that statements included in this report 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 potential timing of
FDA action on the NDA and potential approval and product launch for Gimoti; the
timing and results of any decision regarding the Gimoti NDA from the FDA,
including whether FDA will act by the PDUFA target goal date; the Company's
belief that Gimoti, if approved, can will provide an alternative to patients
suffering from gastroparesis; and whether the Company's partnership with
EVERSANA Life Sciences has laid the foundation for efficient and rapid
commercialization of Gimoti, if approved. The inclusion of forward-looking
statements should not be regarded as a representation by the Company that any of
its plans will be achieved. Actual results may differ from those set forth in
this report due to the risks and uncertainties inherent in the Company's
business, including, without limitation: the scope of trademark protection may
not provide the protections the Company expects; the potential for the FDA to
delay the PDUFA target goal date due to the FDA's internal resource constraints
or other reasons; the Company may be unable to timely and successfully address
the deficiencies raised in the Complete Response Letter (CRL) regarding Gimoti,
including as a result of adverse findings from a root cause analysis or data
from the newly manufactured product batches not fully addressing issues raised
by the FDA in the CRL and type A meeting; FDA may not agree with the Company's
conclusion of the results from the manufacturing testing or the root cause
analysis, or may require the Company to conduct additional studies; the inherent
risks of clinical development and regulatory approval of Gimoti; Evoke's
dependence on third parties for the manufacture of Gimoti and analysis of the
manufacturing data; the Company is entirely dependent on the success of Gimoti;
the Company will require substantial additional funding to continue its
operations into the second quarter of 2020, and may be unable to raise capital
or obtain funds when needed, including to fund ongoing operations; the Company
could face significant additional costs due to litigation or other events; and
other risks detailed in the Company's 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 the Company undertakes no obligation to revise or update this report
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.
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