EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other Events
Item 8.01Other Events.
On September 17, 2019, Evoke Pharma, Inc. (“Evoke” or “Company”) announced that it has completed manufacturing commercial scale batches of its product candidate Gimoti (metoclopramide nasal spray) with its partner Thermo Fisher Scientific, a leading global contract development and manufacturing organization that specializes in the preparation, fill and finish of nasal spray products.
Evoke plans to collect Chemistry, Manufacturing and Controls (“CMC”) data from these registration batches, which were requested in the complete response letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”). These data will be used to support the proposed acceptance criteria for droplet size distribution and other performance characteristics and device quality control and will be included in Evoke’s planned resubmission of the 505(b)(2) New Drug Application (“NDA”) for Gimoti in the fourth quarter of this year.
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 Company’s plans to use the CMC data from the registration batches to support the resubmission of the Gimoti NDA; the addressability of the approvability issues cited by FDA in the CRL, including with respect to the performance characteristics and root cause analysis regarding the pharmacokinetic variability; and the potential for an NDA resubmission in the fourth quarter. 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 CMC data from the registration batches may not support the acceptance criteria for droplet size distribution and other performance characteristics and device quality control; Evoke may be unable to timely and successfully address the deficiencies raised in the CRL, including as a result of adverse findings from a root cause analysis or data from the completed registration manufactured product batches; FDA may not agree with the Company’s conclusion of the root cause analysis or analysis of the CMC data from the registration batches or may require the Company to conduct additional studies; the inherent risks of clinical development of Gimoti; the Company’s dependence on third parties for the manufacture of Gimoti and analysis of the PK data; the Company is entirely dependent on the success of Gimoti, and the Company cannot be certain that FDA will accept or approve an NDA resubmission for Gimoti; The Company will require substantial additional funding to address the deficiencies raised in the CRL, 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; the Company’s ability to maintain the continued listing of its common stock on the Nasdaq Capital Market; and other risks detailed in the Company’s prior reports filed 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.