UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
EVOKE PHARMA, INC.
(Exact Name of Registrant as Specified in its Charter)
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Securities registered pursuant to Section 12(b) of the Exchange Act |
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par value $0.0001 per share |
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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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 September 29, 2021, Evoke Pharma, Inc. (“Evoke” or the “Company”) and EVERSANA™, the Company’s commercialization partner, announced that PM360, a publication for marketing decision makers in the pharmaceutical, biotech, and medical device industries named both companies as the Sales Aid Silver Award Winner for GIMOTI® under the Trailblazer Initiative Awards during PM360’s annual awards ceremony on September 23, 2021.
Received as a result of the “Spray Away Campaign” developed by Evoke Pharma and EVERSANA ENGAGE, the Sales Aid Award is in recognition of the creative execution of the overall campaign and clarity of message emphasizing the “spray” component of the solution which is the novel element of GIMOTI, especially since these patients typically have compromised absorption of oral medications. This campaign reflects the insight gained from patient market research and listening to patients with diabetic gastroparesis on social media which are filled with posts of patients seeking relief of symptoms and chronicle their difficulties in taking oral medicines. The companies’ winning application for the 2021 PM360 Trailblazer Award in the Sales Aid Category titled, “Engaging Sales Collateral to Bring New Hope and Treatment for Patients with Diabetic Gastroparesis” described the use of visuals to reinforce the merits of GIMOTI’s route of administration and prominently showcases the GIMOTI nasal spray system and container and mist underscoring the point of differentiation for GIMOTI.
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 size of the gastroparesis market and the potential of GIMOTI to treat patients with diabetic gastroparesis. 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 EVERSANA’s ability to successfully drive market demand for GIMOTI; 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; the Company 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 prior reports 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 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.
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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EVOKE PHARMA, INC. |
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Date: September 29, 2021 |
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By: |
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/s/ Matthew J. D’Onofrio |
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Matthew J. D’Onofrio |
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Executive Vice President, |