Evoke Pharma
Mar 21, 2017

Evoke Pharma's Phase 3 Results for Gimoti Accepted as Late-Breaker for Presentation at Digestive Disease Week 2017

SOLANA BEACH, Calif., March 21, 2017 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company's abstract detailing compelling Phase 3 trial data for Gimoti™ (metoclopramide nasal spray) for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women, was accepted for a poster presentation at Digestive Disease Week® (DDW) 2017.

The poster presentation is entitled: Symptom Severity Influences Drug Efficacy in Women with Diabetic Gastroparesis: Results of a Phase 3 Study with Metoclopramide Nasal Spray.

"We are honored to be chosen to present the data from our Phase 3 trial for Gimoti at the upcoming DDW meeting," stated Marilyn R. Carlson, DMD, MD, Chief Medical Officer at Evoke Pharma. "It is an opportunity to share the benefits demonstrated in patients with moderate to severe gastroparesis symptoms who are most in need of effective treatment. We believe the presentation will prove valuable to scientists and clinicians who attend the meeting to learn more about the latest research and the promising new treatments in the field of GI motility. Evoke shares their commitment to improving the quality of life and the well-being of patients with diabetic gastroparesis."

The lead author, Richard McCallum, MD, Professor and Founding Chair, Department of Medicine & Director of the Center for Neurogastroenterology & GI Motility at Texas Tech University Health Sciences Center, El Paso, and a key opinion leader in gastroparesis stated, "Patients suffering from moderate to severe gastroparesis symptoms are limited in their day-to-day activities and require frequent interactions with the healthcare system. As a clinical researcher and treating physician, I am well aware of the treatment options currently available and the protracted timeline for new therapies entering early phase clinical trials. These encouraging data from Evoke's Phase 3 trial for Gimoti, help validate the therapeutic benefits of nasal delivery of metoclopramide and provide hope that there will be a non-oral treatment option for patients suffering from diabetic gastroparesis in the near future."

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: Evoke's plans to present at DDW and discuss the data from its Phase 3 trial for Gimoti; the benefits Gimoti may have for patients with moderate to severe gastroparesis symptoms; the utility of the Gimoti data to scientists and clinicians at DDW. 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 pharmacokinetic (PK) trial; later developments with the Food and Drug Administration (FDA) that may be inconsistent with the already completed pre-new drug application (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 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.

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