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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(IRS Employer</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:6pt;">&#160;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Securities registered pursuant to Section 12(b) of the Exchange Act</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;;font-size:6pt;">&#160;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;;font-size:6pt;">&#160;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;;font-size:6pt;">&#160;</p></td>
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<td valign="top">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Title of each class</p></td>
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<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 (<span style="font-style:italic;">see</span> General Instruction A.2. below): </p>
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<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter).</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 8.01&#160;&#160;&#160;&#160; Other Events.&#160;&#160; </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On September 20, 2022, Evoke Pharma, Inc.&#160;(&#8220;Evoke&#8221; or the &#8220;Company&#8221;) announced <span style="color:#000000;">the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Application No. 16/469,092 for the </span>Company&#8217;s product, <span style="color:#000000;">GIMOTI&#174; (metoclopramide) nasal spray</span>. <span style="color:#000000;">The patent application, entitled &#8220;Treatment of Moderate and Severe Gastroparesis,&#8221; covers methods for treating moderate-to-severe gastroparesis with metoclopramide with an intranasal route of administration. The U.S. patent scheduled to issue from this application will expire in 2039 and will be listed in the U.S. Food and Drug Administration&#8217;s Orange Book.</span></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Safe Harbor Statement</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 &#8220;may,&#8221; &#8220;will,&#8221; &#8220;should,&#8221; &#8220;expect,&#8221; &#8220;plan,&#8221; &#8220;anticipate,&#8221; &#8220;could,&#8221; &#8220;intend,&#8221; &#8220;target,&#8221; &#8220;project,&#8221; &#8220;contemplates,&#8221; &#8220;believes,&#8221; &#8220;estimates,&#8221; &#8220;predicts,&#8221; &#8220;potential&#8221; or &#8220;continue&#8221; or the negatives of these terms or other similar expressions. These statements are based on the company&#8217;s current beliefs and expectations. These forward-looking statements include statements regarding: the anticipated scope and term of any patent protection for GIMOTI and the expected inclusion of any new patent in the U.S. Food and Drug Administration&#8217;s Orange Book. 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&#8217;s business, including, without limitation: Evoke&#8217;s ability to obtain, maintain and successfully enforce intellectual property protection for GIMOTI&#59; Evoke&#8217;s and EVERSANA&#8217;s ability to successfully drive market demand for GIMOTI&#59; Evoke&#8217;s ability to obtain additional financing as needed to support its operations&#59; the COVID-19 pandemic may continue to disrupt Evoke&#8217;s and EVERSANA&#8217;s business operations impairing the ability to commercialize GIMOTI and Evoke&#8217;s ability to generate any product revenue&#59; Evoke&#8217;s dependence on third parties for the manufacture of GIMOTI&#59; Evoke is entirely dependent on the success of GIMOTI&#59; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims&#59; and other risks and uncertainties detailed in Evoke&#8217;s prior press releases and in the periodic reports it files with the&#160;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.</p>
<p style="margin-bottom:10pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><br /></p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&#160;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:11pt;">&#160;</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">EVOKE PHARMA, INC.</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:11pt;">&#160;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">By:&#160;&#160;<span style="text-decoration:underline;">/s/ Matthew J. D&#8217;Onofrio</span>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;Matthew J. D&#8217;Onofrio</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;Executive Vice President,</p></td>
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evok-8k_20220920.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
September 20, 2022
EVOKE PHARMA, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
001-36075
20-8447886
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
420 Stevens Avenue
,
Suite 370
Solana Beach
,
California
92075
(Address of Principal Executive Offices)
(Zip Code)
Registrant's telephone number, including area code:
(858)
345-1494
(Former Name or Former Address, if Changed Since Last Report.)
Securities registered pursuant to Section 12(b) of the Exchange Act
Title of each class
Trading symbol
Name of each exchange on which registered
Common Stock,
par value $0.0001 per share
EVOK
The
Nasdaq
Capital Market
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):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 20, 2022, Evoke Pharma, Inc. ("Evoke" or the "Company") announced
the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Application No. 16/469,092 for the
Company's product,
GIMOTI® (metoclopramide) nasal spray
.
The patent application, entitled "Treatment of Moderate and Severe Gastroparesis," covers methods for treating moderate-to-severe gastroparesis with metoclopramide with an intranasal route of administration. The U.S. patent scheduled to issue from this application will expire in 2039 and will be listed in the U.S. Food and Drug Administration's Orange Book.
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 anticipated scope and term of any patent protection for GIMOTI and the expected inclusion of any new patent in the U.S. Food and Drug Administration's Orange Book. 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's ability to obtain, maintain and successfully enforce intellectual property protection for GIMOTI; Evoke's and EVERSANA's ability to successfully drive market demand for GIMOTI; 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.
September 20, 2022
EVOKE PHARMA, INC.
By:
/s/ Matthew J. D'Onofrio
Matthew J. D'Onofrio
Executive Vice President,
Chief Business Officer and Secretary