EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Results of Operations and Financial Condition

ME Staff 8-k
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EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Results of Operations and Financial Condition
Item 2.02

On January 13, 2021, Evoke Pharma, Inc. (the “Company”) disclosed that its cash and cash equivalents were approximately $8.1 million as of December 31, 2020. This amount has not been audited, reviewed or compiled by our independent registered public accounting firm and is preliminary, and does not present all information necessary for an understanding of our financial condition as of December 31, 2020. The audit of our financial statements for the year ended December 31, 2020 is ongoing and could result in changes to this amount.

On January 13, 2021, the Company announced that during December 2020, the Company, through its marketing partner, Eversana Life Science Services, LLC (“Eversana”), conducted an ATU (Awareness, Trial, and Usage) Study, a quantitative survey to measure physician awareness, trial, and product usage, for GIMOTI. Approximately 104 total physician responses were captured. Survey respondents were split into three groups drawn from the healthcare practitioner (“HCP”) community; “target” gastroenterologists currently being called on by the field sales force (n = 61), other “non-target” gastroenterologists (n = 19), and primary care physicians (PCPs) who are not currently targeted for messaging (n = 24). Areas of interest that were queried included initial and future potential prescribing trends, and how HCPs viewed the suitability of GIMOTI in certain gastroparesis patient populations. The results of the ATU survey may not predict prescribing trends by doctors or acceptance by patients, and are not intended to reflect or imply actual prescriptions or sales to date.

Key Findings:

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 unaudited cash and cash equivalents as of December 31, 2020; potential future prescribing trends for GIMOTI based on this survey of HCPs or the Company’s marketing efforts; and the Company’s commercialization plans, including its plans to increase awareness and access to GIMOTI. 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 report due to the risks and uncertainties inherent in the Company’s business, including, without limitation: risks related to the preliminary, unaudited financial results, including the risks that the unaudited financial results reported herein reflect information available to the Company only at this time and may differ from actual results, including in connection with the Company’s completion of financial closing procedures; the Company’s and Eversana’s ability to successfully drive market demand for GIMOTI; the results of the ATU survey may not predict prescribing trends by doctors or acceptance by patients, and are not intended to reflect or imply actual prescriptions or sales to date; the Company’s ability to obtain additional financing as needed to support its operations, including through the Eversana line of credit which is subject to certain customary conditions; the COVID-19 pandemic may disrupt the Company’s and Eversana’s business operations impairing the ability to commercialize GIMOTI and the Company’s ability to generate any product revenue; the Company’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; the Company’s ability to obtain and maintain intellectual property protection for GIMOTI; and other risks detailed in the Company’s 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 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.