<SEC-DOCUMENT>0001157523-23-000798.txt : 20230510
<SEC-HEADER>0001157523-23-000798.hdr.sgml : 20230510
<ACCEPTANCE-DATETIME>20230510073342
ACCESSION NUMBER:		0001157523-23-000798
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20230510
FILED AS OF DATE:		20230510
DATE AS OF CHANGE:		20230510

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:		23904356

	BUSINESS ADDRESS:	
		STREET 1:		FIRST CANADIAN PLACE
		STREET 2:		100 KING STREET WEST, SUITE 4000
		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 4000
		CITY:			TORONTO
		STATE:			A6
		ZIP:			M5X 1A4
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a53397039.htm
<DESCRIPTION>FSD PHARMA INC. 6-K
<TEXT>
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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>
    <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>May 2023</u></font></div>
    <div style="font-family: 'Times New Roman',Times,serif;"><br>
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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; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">FSD PHARMA INC.</div>
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    <div style="text-align: center; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">(Translation of registrant&#8217;s name into English)</div>
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    <div style="text-align: center; font-family: 'Times New Roman',Times,serif;">199 Bay St., Suite 4000</div>
    <div style="text-align: center; font-family: 'Times New Roman',Times,serif;">Toronto, Ontario M5L 1A9, Canada</div>
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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>
    <div style="font-family: 'Times New Roman',Times,serif;"><br>
    </div>
    <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">Form 20-F&#160;&#9746;</font><font class="TRGRRTFtoHTMLTab" style="text-indent: 0px; font-family: 'Times New Roman',Times,serif;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font style="font-family: 'Times New Roman',Times,serif;"><font style="color: rgb(35, 31, 32);">Form 40-F </font>&#9744;</font></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)(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; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-weight: bold;">SIGNATURES</div>
    <div style="font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-indent: 36pt; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">&#160;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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              <div>FSD Pharma Inc.</div>
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              <div>&#160;</div>
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              <div>&#160;</div>
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              <div>(Registrant)</div>
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              <div>&#160;</div>
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              <div>Date:&#160; May 10, 2023</div>
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              <div>By:</div>
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              <div> /s/ Nathan Coyle</div>
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              <div>&#160;</div>
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              <div>&#160;</div>
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              <div>Nathan Coyle, Chief Financial Officer</div>
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    <div style="text-align: center; font-family: 'Times New Roman',Times,serif; font-weight: bold;">EXHIBIT INDEX</div>
    <div style="font-family: 'Times New Roman',Times,serif;">&#160;</div>
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            <div style="color: rgb(0, 0, 0); font-weight: bold;"><u>Exhibit</u></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);"><a href="a53397039ex99_1.htm">Exhibit 99.1</a> <br>
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          <td style="width: 85.52%; vertical-align: middle; font-family: 'Times New Roman',Times,serif;">
            <div style="color: rgb(0, 0, 0);"><a href="a53397039ex99_1.htm">Press Release &#8211; Dated May 10, 2023 - FSD Pharma Completes Dosing of First Cohort
                in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee Recommends Commencing Dosing of Second Cohort</a></div>
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<TYPE>EX-99.1
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<FILENAME>a53397039ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
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  <div style="text-align: right;"><font style="font-weight: bold;">Exhibit 99.1<br>
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      <h1 style="text-align: center; list-style-position: inside;FONT-SIZE: 14pt;"> <b>FSD Pharma Completes Dosing of First Cohort in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee
          Recommends Commencing Dosing of Second Cohort</b> </h1>
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          <p>TORONTO--(BUSINESS WIRE)--May 10, 2023--FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) (&#8220;<b>FSD Pharma</b>&#8221; or the &#8220;<b>Company</b>&#8221;), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech
            solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, today announced the completion of dosing the first cohort of patients in the Company&#8217;s Phase I clinical trial of Lucid-21-302 (&#8220;Lucid-MS&#8221;). The
            clinical trial (ClinicalTrials.gov Identifier: NCT05821387), being conducted by FSD Pharma through the Company&#8217;s wholly owned subsidiary Lucid Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a small molecule inhibitor of
            hypercitrullination, as a novel drug candidate for the treatment of Multiple Sclerosis (&#8220;MS&#8221;). </p>
          <p> &#8220;Our clinical development team and international advisory committee are delighted at the progress of this milestone and completing dosing the first cohort,&#8221; said Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals. &#8220;The safety review committee
            has recommended to move forward with the next cohort dosing, which we are thrilled to say is expected to commence in the next few days.&#8221; </p>
          <p> The clinical trial is a randomized, double-blind, placebo controlled, single ascending dose (&#8220;SAD&#8221;) and multiple ascending dose (&#8220;MAD&#8221;) study with the primary outcomes evaluating the safety, tolerability, and pharmacokinetics of Lucid-MS in
            healthy volunteers under fed and fasted conditions. Enrollment will be comprised of five SAD cohorts and two MAD cohorts. Each SAD and MAD cohort will enroll eight participants (for a total of 56 participants) randomized to six active and two
            placebo groups. Participants in the active group will receive single or multiple doses of Lucid-MS. For the SAD cohort with food effect, all eight participants will receive Lucid-MS. </p>
          <p> Lucid-MS is a patented first-in-class, New Chemical Entity (&#8220;NCE&#8221;) and a neuroprotective compound with a novel mechanism of action for the treatment of MS. In preclinical models, Lucid-MS has been shown to prevent myelin degradation
            (demyelination), a hallmark pathology feature of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers in the central nervous system. Preclinical evidence has demonstrated Lucid-MS to
            promote functional recovery in experimental animal models of MS (https://fsdpharma.com/our-science/). Based on current evidence, Lucid-MS is non-immunomodulatory agent, an important distinction in the potential for developing new, safe options
            for treating MS. </p>
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          </div>
          <p> <b>About FSD Pharma</b> </p>
          <p> FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc., a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, FSD201, a
            proprietary ultra-micronized PEA formulation, for the treatment of inflammatory diseases. Lucid Psychss Inc., a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-Psych and Lucid-MS. Lucid-Psych is
            a molecular compound identified for the potential treatment of mental health disorders, and expanding this category, the Company is investigating other products addressing acute medical needs due to the abuse of drugs such as alcohol. Lucid-MS
            is a molecular compound identified for the potential treatment of neurodegenerative disorders. </p>
          <p> <b>Forward Looking Information</b> </p>
          <p> This press release contains forward-looking statements and forward-looking information (collectively, "<b>forward-looking statements</b>")<b> </b>within the meaning of applicable securities laws. Any statements that are contained in this
            press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as &#8220;plans&#8221;, &#8220;expects&#8221;, &#8220;expected&#8221;, &#8220;scheduled&#8221;, &#8220;estimates&#8221;, &#8220;intends&#8221;,
            &#8220;anticipates&#8221;, &#8220;hopes&#8221;, &#8220;planned&#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;, &#8220;potentially&#8221; or &#8220;will&#8221; be taken, occur or be achieved. More
            particularly, and without limitation, this press release contains forward-looking statements contained in this press release include statements concerning the future of FSD Pharma Inc. and are based on certain assumptions that FSD Pharma has
            made in respect thereof as of the date of this press release. FSD Pharma cannot give any assurance that such forward-looking statements will prove to have been correct. </p>
          <p> Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it believes the expectations and
            material factors and assumptions reflected in these forward-looking statements are reasonable as of the date hereof, there can be no assurance that these expectations, factors and assumptions will prove to be correct and these risks and
            uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to a
            number of known and unknown risks and uncertainties including, but not limited to: the fact that the drug development efforts of both Lucid and FSD BioSciences are at a very early stage; the fact that preclinical drug development is uncertain,
            and the drug product candidates of Lucid and FSD BioSciences may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials;
            the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of Lucid and FSD BioSciences; the uncertain clinical development process, including the risk that clinical trials may not have an
            effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of Lucid and FSD BioSciences; the introduction of competing drugs that are safer, more effective or
            less expensive than, or otherwise superior to, the drug product candidates of Lucid and FSD BioSciences; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected, or impacted by
            COVID-19 related issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of Lucid and FSD BioSciences; and other risks.
            Accordingly, readers should not place undue reliance on the forward-looking statements contained in this press release, which speak only as of the date of this press release. </p>
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          </div>
          <p> Further information regarding factors that may cause actual results to differ materially are included in the Company&#8217;s annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR (www.sedar.com) and
            with the U.S. Securities and Exchange Commission on EDGAR (www.sec.gov), including the Company&#8217;s Annual Report on Form 20-F for the fiscal year ended December 31, 2021, under the heading &#8220;Risk Factors.&#8221; This list of risk factors should not be
            construed as exhaustive. Readers are cautioned that events or circumstances could cause results to differ materially from those predicted, forecasted or projected. The forward-looking statements contained in this document speak only as of the
            date of this document. FSD Pharma does not undertake any obligation to publicly update or revise any forward-looking statements or information contained herein, except as required by applicable laws. The forward-looking statements contained in
            this document are expressly qualified by this cautionary statement. </p>
          <p> <i>Neither the Canadian Securities Exchange nor its regulation services provider accept responsibility for the adequacy or accuracy of this release.</i> </p>
        </div>
        <div class="bw-release-contact">
          <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
          <p> Zeeshan Saeed, Founder, President and Executive Co-Chairman of the Board, FSD Pharma Inc. <br>
            Email: Zsaeed@fsdpharma.com<br>
            Telephone: (416) 854-8884 </p>
          <p> Investor Relations: <br>
            Email: ir@fsdpharma.com, info@fsdpharma.com<br>
            Website: www.fsdpharma.com<br>
            ClearThink <br>
            Email: nyc@clearthink.capital<br>
            Telephone: (917) 658-7878 </p>
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