EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other EventsItem 8.01Other Events.
On March 21, 2018, Evoke Pharma, Inc. (“Evoke” or the “Company”) entered into an Amendment to Asset Purchase Agreement (the “Amendment”) with Mallinckrodt ARD Inc. (formerly known as Questcor Pharmaceuticals, Inc.) (“Mallinckrodt”) to amend certain terms of the Asset Purchase Agreement, dated as of June 1, 2007 (as subsequently amended, the “Asset Purchase Agreement”). to the Amendment, Mallinckrodt has agreed to modify the two milestone payments, namely the $1.5 million payments due upon acceptance of the new drug application (“NDA”) for Gimoti and the $3.0 million due upon approval of the Gimoti NDA by the Food and Drug Administration (“FDA”), to a single $5.0 million milestone payment due one year after FDA approval, if any, of the Gimoti NDA.
As a result of the Amendment, Evoke believes that its existing cash and cash equivalents will be sufficient to fund its operations into January 2019.
The foregoing summary of the material terms of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which will be filed with the Securities and Exchange Commission by Evoke on its Quarterly Report on Form 10-Q for the period ending March 31, 2018.
Safe Harbor Statement
The Company 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: anticipated timing to submit an NDA for Gimoti; the potential timing of FDA approval, if any, of the NDA for Gimoti; and Evoke’s projected cash runway. 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: Evoke may spend its available cash faster than it anticipates; the FDA may disagree that the existing safety database is sufficient to allow an NDA submission and approval; risks associated with FDA review of the final results from the comparative exposure pharmacokinetic (PK) trial, including the FDA may not agree with Evoke's interpretation of such results; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings and most recent correspondence; 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; Evoke will require substantial additional funding to conduct any new safety trials required by the FDA, and may be unable to raise capital when needed, including to fund ongoing operations; 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.
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.
