EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other Events
Item 8.01Other Events.
On July15, 2020, Evoke Pharma, Inc. (the “Company”) announced that it has initiated the commercial manufacturing of GIMOTI™ (metoclopramide) nasal spray with its manufacturing partner, Patheon, a division of Thermo Fisher Scientific, Inc. GIMOTI was approved by the U.S. Food and Drug Administration on June 19, 2020 for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The Company plans to launch sales of GIMOTI in the fourth quarter 2020 with its partner EVERSANA.
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 timing of completing the commercial manufacturing of GIMOTI and other pre-commercialization activities; the timing of the commercial launch of GIMOTI and commercial activities to be conducted by EVERSANA; and the size of the gastroparesis market and the potential of GIMOTI to provide an important new alternative to current treatment options. 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 Company’s and Patheon’s ability to successfully complete the commercial manufacturing of GIMOTI; the Company’s and EVERSANA’s ability to successfully launch and drive market demand for GIMOTI and the timing thereof; the Company’s ability to obtain additional financing as needed to support its operations, including through its existing line of credit with EVERSANA which is subject to certain customary conditions; the COVID-19 pandemic may disrupt the Company’s, Patheon’s and EVERSANA’s business operations impairing the ability to manufacture or commercialize GIMOTI and the Company’s ability to generate any product revenue; the Company’s dependence on third parties for the manufacture of GIMOTI; the Company is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could delay or prevent commercialization, or that could result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for GIMOTI; and other risks detailed in the Company’s prior 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.
About EVOKE PHARMA, INC. (NASDAQ:EVOK)
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.
