On September 7, 2016, Evoke Pharma, Inc. (the Company) announced that it
has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti, its patented nasal delivery formulation of metoclopramide for the
relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical
sections of the Companys planned NDA filing for Gimoti.
Prior to the pre-NDA meeting, the Company submitted an information package describing the
proposed content and format of the regulatory, CMC, and non-clinical sections of the Gimoti NDA. The subsequent face-to-face pre-NDA meeting afforded the Company the opportunity to gain further understanding of the FDAs expectations regarding
these key sections of the NDA.
Based on the FDAs response to the information package and the pre-NDA meeting discussion, the Company believes it
now has the information needed to complete these sections of the NDA in a manner that will be acceptable for the FDAs review of the complete package.
The Company expects to request an additional pre-NDA meeting with the FDA in the near future regarding the clinical data to be included in the NDA.
Forward-Looking Statements.
The Company cautions you
that statements included in this Current Report on Form 8-K 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 Companys current beliefs and expectations. These forward-looking statements
include statements regarding: Gimotis potential to benefit patients suffering from gastroparesis; potential NDA submission and regulatory pathway submission strategies for Gimoti, including the Companys belief that the sections of the
NDA regarding the regulatory, CMC and non-clinical information will be acceptable to the FDA; the timing, if any, of an additional pre-NDA meeting with the FDA to discuss the clinical sections of the NDA; and the potential for regulatory approval
and commercialization of Gimoti. 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 press release due
to the risk and uncertainties inherent in the Companys business, including, without limitation: additional analyses of data from the Phase 3 trial may produce negative or inconclusive results and may not serve as the basis for an NDA
submission or regulatory approval; the final FDA minutes may be inconsistent with the Companys understanding of the FDAs position on the matters addressed at the meeting;, or may be inconsistent with previously announced topline results;
the inherent risks of clinical development of Gimoti; the Company is entirely dependent on the success of Gimoti, and it cannot be certain that it will be able to conduct additional trials of Gimoti or obtain regulatory approval for or successfully
commercialize Gimoti; the Company 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; the Company 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 the periodic reports the Company 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.