UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On February 24, 2022, Evoke Pharma, Inc. (“Evoke” or the “Company”) announced that the results of a retrospective analysis of United States administrative claims data that examined the association between metoclopramide-induced tardive dyskinesia (TD) and potential risk factors will be presented at the annual Digestive Disease Week Meeting (DDW 2022) taking place in San Diego, California from May 21-24, 2022.
The Company’s product, GIMOTI, is an FDA-approved novel nasal formulation of metoclopramide that is commercially available and specifically designed to deliver a non-oral dose of metoclopramide for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Selected as a poster of distinction during DDW 2022, the presentation titled “Revisiting the Risk of Tardive Dyskinesia with Metoclopramide Use: A Real-World Data Driven Epidemiology Study From 2011-2021” will cover the data analytics of an 80 million patient database (Truven Health MarketScan®) used to conduct the most comprehensive analysis to date on the risk of metoclopramide-induced TD. In the limited literature available, the reported incidence of TD varies widely. The approved labeling for Gimoti includes a black box warning regarding the risks of tardive dyskinesia, a serious movement disorder that is often irreversible, associated with metoclopramide.
Details of the poster presentation are as follows:
Session Title: Gastroparesis and Small Intestinal Dysmotility
Presentation Title: “Revisiting the Risk of Tardive Dyskinesia with Metoclopramide Use: A Real-World Data Driven Epidemiology Study From 2011-2021”
Date: May 21, 2022
Time: 12:30 p.m. – 1:30 p.m. PDT
Location: San Diego Convention Center
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: the association between TD and metoclopramide to be presented in the poster at DDW 2022. 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: the data from a retrospective analysis may not be as robust as data from a controlled clinical trial and such data does not otherwise effective the black box warning on the Gimoti label related to TD; Evoke’s ability to obtain additional financing as needed to support its operations; the COVID-19 pandemic may continue to disrupt Evoke’s and EVERSANA’s business operations impairing the ability to commercialize GIMOTI and Evoke’s ability to generate any product revenue; Evoke’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; and other risks and uncertainties 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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February 24, 2022 |
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EVOKE PHARMA, INC. |
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By: /s/ Matthew J. D’Onofrio |
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Matthew J. D’Onofrio |
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Executive Vice President, |
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Chief Business Officer and Secretary |
Document and Entity Information |
Feb. 24, 2022 |
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| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Feb. 24, 2022 |
| Entity Registrant Name | EVOKE PHARMA, INC. |
| Entity Central Index Key | 0001403708 |
| Entity Emerging Growth Company | false |
| Entity File Number | 001-36075 |
| Entity Incorporation, State or Country Code | DE |
| Entity Tax Identification Number | 20-8447886 |
| Entity Address, Address Line One | 420 Stevens Avenue |
| Entity Address, Address Line Two | Suite 370 |
| Entity Address, City or Town | Solana Beach |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 92075 |
| City Area Code | (858) |
| Local Phone Number | 345-1494 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock,par value $0.0001 per share |
| Trading Symbol | EVOK |
| Security Exchange Name | NASDAQ |