<SEC-DOCUMENT>0001157523-21-001090.txt : 20210825
<SEC-HEADER>0001157523-21-001090.hdr.sgml : 20210825
<ACCEPTANCE-DATETIME>20210825090038
ACCESSION NUMBER:		0001157523-21-001090
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20210824
FILED AS OF DATE:		20210825
DATE AS OF CHANGE:		20210825

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			FSD Pharma Inc.
		CENTRAL INDEX KEY:			0001771885
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			A6
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39152
		FILM NUMBER:		211204095

	BUSINESS ADDRESS:	
		STREET 1:		FIRST CANADIAN PLACE
		STREET 2:		100 KING STREET WEST, SUITE 3400
		CITY:			TORONTO
		STATE:			A6
		ZIP:			M5X 1A4
		BUSINESS PHONE:		(416) 854-8884

	MAIL ADDRESS:	
		STREET 1:		FIRST CANADIAN PLACE
		STREET 2:		100 KING STREET WEST, SUITE 3400
		CITY:			TORONTO
		STATE:			A6
		ZIP:			M5X 1A4
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a52479125.htm
<DESCRIPTION>FSD PHARMA INC. 6-K
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      <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">UNITED STATES</div>
      <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
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    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-weight: bold;">Washington, D.C. 20549</div>
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      <div style="text-align: center; color: rgb(35, 31, 32); font-weight: bold;">Form 6-K</div>
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    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER</div>
    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-weight: bold;">PURSUANT TO RULE 13a-16 OR 15d-16</div>
    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-weight: bold;">UNDER THE SECURITIES EXCHANGE ACT OF 1934</div>
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    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">For the month of: <font style="font-weight: bold;"><u>August 2021</u></font></div>
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    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">Commission File Number: <font style="font-weight: bold;"><u>001-39152</u></font></div>
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                <div style="text-align: center;"><font style="font-size: 16pt;">FSD PHARMA INC.</font> <br>
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                <div style="text-align: center;">(Translation of registrant&#8217;s name into English) <br>
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                <div style="text-align: center;">&#160;</div>
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                <div style="text-align: center;">First Canadian Place <br>
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                <div style="text-align: center;">100 King Street West, Suite 3400 <br>
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                <div style="text-align: center;">Toronto, ON M5X 1A4, Canada <br>
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                <div style="text-align: center;">(Address of principal executive office) <br>
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    <div style="color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</div>
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    <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">Form 20-F&#160;</font><font style="font-family: 'Times New Roman',Times,serif;">&#9744;</font><font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; width: 144pt; font-family: 'Times New Roman',Times,serif;">&#160;</font><font style="font-family: 'Times New Roman',Times,serif;"><font style="color: rgb(35, 31, 32);">Form 40-F </font><font style="color: rgb(35, 31, 32);">&#9746;</font></font></div>
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    <div style="color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
      ____</div>
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    </div>
    <div style="color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
      ____</div>
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    <div style="text-align: center; margin-top: 12pt; margin-bottom: 12pt; font-family: 'Times New Roman',Times,serif; font-weight: bold;">INCORPORATION BY REFERENCE</div>
    <div style="margin-top: 12pt; margin-bottom: 12pt; font-family: 'Times New Roman',Times,serif;">The Registrant&#8217;s Press Release dated August 24, 2021 and entitled &#8220;FSD Pharma Inc. Announces Termination of
      FSD-201 Phase 2 Clinical Trial&#8221;, included as Exhibit 99.1 of this Form 6-K (Commission File No. 001-39152), furnished to the Commission on the date hereof, is incorporated by reference into the Registrant&#8217;s Registration Statements on Form F-10
      (Commission File Nos. 333-236780 and 333-254995).</div>
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    <div style="text-align: center; margin-top: 3pt; margin-bottom: 3pt; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-weight: bold;">SIGNATURES</div>
    <div style="text-indent: 36pt; margin-top: 3pt; margin-bottom: 3pt; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">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, thereunto duly authorized.</div>
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              <div>&#160;</div>
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            <td style="width: 4%;" rowspan="1" colspan="2">FSD Pharma Inc.</td>
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            <td style="width: 50%;" rowspan="1">&#160;</td>
            <td style="width: 4%;" rowspan="1" colspan="2">(Registrant) <br>
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              <div>&#160;</div>
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              <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(0, 0, 0);">Date:&#160; August 25, 2021</font><font style="display: inline-block; text-indent: 0px; width: 216pt; font-family: 'Times New Roman',Times,serif;">&#160;</font> <br>
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              <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(0, 0, 0);"><font style="color: rgb(0, 0, 0);">By:</font></font> <br>
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              <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(0, 0, 0);"><font style="color: rgb(0, 0, 0);">/s/ Nathan Coyle</font></font> <br>
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              <div>&#160;</div>
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              <div>&#160;</div>
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              <div>Nathan Coyle, Chief Financial Officer <br>
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    <div style="text-align: center; margin-top: 3pt; margin-bottom: 3pt; font-family: 'Times New Roman',Times,serif; font-weight: bold;">EXHIBIT INDEX</div>
    <div style="margin-top: 3pt; margin-bottom: 3pt; font-family: 'Times New Roman',Times,serif;">&#160;</div>
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            <div style="color: rgb(0, 0, 0); font-weight: bold;"><u>Description</u></div>
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            <div style="color: rgb(0, 0, 0);">&#160;</div>
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            <div style="color: rgb(0, 0, 0);"><a href="a52479125_ex991.htm">99.1</a></div>
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          <td style="width: 85%; vertical-align: top; font-family: 'Times New Roman',Times,serif;">
            <div><a href="a52479125_ex991.htm">Press Release dated August 24, 2021 and entitled &#8220;FSD Pharma Inc. Announces Termination of
                FSD-201 Phase 2 Clinical Trial&#8221;</a></div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a52479125_ex991.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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  <div style="text-align: right;"><font style="font-weight: bold;">Exhibit 99.1</font><br>
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      <h1 style="text-align: center; list-style-position: inside;FONT-SIZE: 14pt;"> <b>FSD Pharma Inc. Announces Termination of FSD-201 Phase 2 Clinical Trial</b> </h1>
      <div class="bw-release-subhead">
        <p style="text-align: center; list-style-position: inside;"><b> <b>However, will continue to evaluate other potential commercial opportunities with FSD-201</b> </b></p>
      </div>
      <div class="bw-release-body">
        <div class="bw-release-table-js bw-release-story">
          <p>TORONTO--(BUSINESS WIRE)--August 24, 2021--FSD Pharma Inc. (Nasdaq:HUGE) (CSE:HUGE) (FRA:0K9) (the &#8220;<b>Company</b>&#8221; or &#8220;<b>FSD</b>&#8221;) announced today that it intends to terminate the Phase 2 clinical trial of ultra-micronized
            palmitoylethanolamide ("PEA"), or FSD-201, for use in treating COVID-19. </p>
          <p> FSD-201 stabilizes mast cells and down-regulates the pro-inflammatory cytokines to effectuate an anti-inflammatory response; it is also known to target the CB2 receptors of the endocannabinoid system of the human body.<b> </b> </p>
          <p> The Company has previously successfully completed a Phase 1 first-in-human safety and tolerability study for FSD-201 and the compound to be safe with no serious adverse side effects. In June 2020, the United States Food and Drug
            Administration (the "FDA") approved the submission of an Investigational New Drug Application ("IND") for the use of FSD-201 to treat COVID-19 and in September 2020, a randomized, controlled, double-blind, multicenter Phase 2 clinical study was
            approved by the FDA. The Company is working to complete and publish these findings in the near future. </p>
          <p> As previously disclosed, following the May 14, 2021 annual general and special meeting of shareholders, the Company retained Bloom Burton Securities Inc. (&#8220;Bloom Burton&#8221;) to undertake a review of its Phase 2 clinical program to assist the
            Company in determining its viability and, more broadly, evaluating the general current commercial viability of FSD-201. In particular, the Company was concerned with the pace of progress in advancing the Phase 2 clinical study during a period
            in which COVID-19 treatments evolved significantly and competitive products were being successfully advanced. Bloom Burton recently reported its findings and the Company concluded that, while there are potential commercial opportunities for
            FSD-201, specifically the treatment of COVID-19 by FSD-201 is unlikely to be commercially viable. Based on this information, the Company has elected to terminate the current Phase 2 clinical study in order to concentrate its resources on more
            commercially viable opportunities. </p>
          <p> &#8220;We remain committed to fulfilling the strategic and operational goals outlined in our communications to shareholders prior to the May 14, 2021 shareholder meeting. Objectively evaluating the commercial viability of this Phase 2 study of
            FSD-201 was one of our immediate priorities. While we are disappointed that the Phase 2 study commenced under the Company&#8217;s prior management was not productive, we are pleased that the independent review did support the belief that there are
            other viable commercial opportunities for FSD-201,&#8221; said Zeeshan Saeed, the Company&#8217;s President. &#8220;We will continue to explore these potential opportunities to advance the commercialization of FSD-201 and it&#8217;s potential on the human
            endocannabinoid system,&#8221; he added. </p>
          <p> <b>About FSD Pharma</b> </p>
          <p> FSD Pharma Inc. (www.fsdpharma.com) is a publicly-traded holding company. </p>
          <p> FSD BioSciences, Inc., a wholly-owned subsidiary, is a specialty biotech pharmaceutical R&amp;D company focused on developing multiple applications of its lead compound, ultramicro PEA by down-regulating the cytokines to effectuate an
            anti-inflammatory response. </p>
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          <p> <b>Forward Looking Information</b> </p>
          <p> Certain statement contained herein are &#8220;forward-looking statements&#8221;. Often, but not always, forward-looking statement can be identified by the use of words such as &#8220;plans&#8221;, &#8220;expects&#8221;, &#8220;expected&#8221;, &#8220;scheduled&#8221;, &#8220;estimates&#8221;, &#8220;intends&#8221;,
            &#8220;anticipates&#8221; or &#8220;believes&#8221;, or variations of such words and phrases, or states that certain actions, events or results &#8220;may&#8221;, &#8220;could&#8221;, &#8220;would&#8221;, &#8220;might&#8221; or &#8220;will&#8221; be taken, occur or be achieved. Forward-looking statements contained in this
            press release include the comments made with respect to the Company&#8217;s clinical trial, the evaluation of the commercial viability of its principal drug compound, and the statements made by Zeeshan Saeed regarding the commercial opportunities the
            Company&#8217;s principal drug compound and other commercial opportunities and fulfilling strategic and operational goals outlined in prior communications to shareholders. FSD cannot give any assurance that such forward-looking statements will prove
            to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. </p>
        </div>
        <div class="bw-release-contact">
          <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
          <p> Anthony Durkacz <br>
            1-844-978-3540 <br>
            adurkacz@fsdpharma.com </p>
          <p> Zeeshan Saeed <br>
            1-844-978-3540 <br>
            zsaeed@fsdpharma.com </p>
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