<SEC-DOCUMENT>0001157523-21-000634.txt : 20210510
<SEC-HEADER>0001157523-21-000634.hdr.sgml : 20210510
<ACCEPTANCE-DATETIME>20210510083046
ACCESSION NUMBER:		0001157523-21-000634
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20210510
FILED AS OF DATE:		20210510
DATE AS OF CHANGE:		20210510

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:		21905364

	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>a52426277.htm
<DESCRIPTION>FSD PHARMA INC. 6-K
<TEXT>
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      <div style="text-align: center; margin-right: 14.1pt; margin-left: 16.3pt; margin-top: 0.5pt; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; margin-right: 13.8pt; margin-left: 16.3pt; margin-top: 0.5pt; color: #231F20; font-weight: bold;">Washington, D.C. 20549</div>
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      <div style="text-align: center; margin-bottom: 8pt; font-family: 'Times New Roman',Times,serif; font-size: 16pt;"><font style="font-weight: bold;">Form 6-K</font></div>
      <div style="text-align: center; margin-bottom: 8pt; font-family: 'Times New Roman',Times,serif;"><font style="font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE<br>
          SECURITIES EXCHANGE ACT OF 1934</font></div>
      <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">For&#160; the month of </font><u><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">May</font><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">, 20</font><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">21</font></u><font style="display: inline-block; width: 265.95pt; font-family: 'Times New Roman',Times,serif;" id="TRGRRTFtoHTMLTab">.</font><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);"></font></div>
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      <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">Commission File Number&#160; <u>001-39152</u></font></div>
      <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);"><u> <br>
          </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, 100 King Street West, Suite 3400, 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><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);"> <br>
      </font></div>
    <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</font></div>
    <div><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">Form 20-F </font><font style="font-family: 'Times New Roman',Times,serif;">&#9744;</font><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">&#160;</font><font style="font-family: 'Times New Roman',Times,serif; color: rgb(35, 31, 32);">Form 40-F &#9746;</font>
      <div style="font-family: 'Times New Roman',Times,serif;"><br>
      </div>
      <div style="font-family: 'Times New Roman',Times,serif;">
        <div style="color: #231F20; 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>
        <div><br>
        </div>
        <div style="color: #231F20; font-family: 'Times New Roman', Times, serif;"><font style="font-weight: bold;">Note</font>: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached
          annual report to security holders.</div>
        <div><br>
        </div>
        <div style="color: #231F20; 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>
        <div><br>
        </div>
        <div style="color: #231F20; font-family: 'Times New Roman', Times, serif;"><font style="font-weight: bold;">Note</font>: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other
          document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant&#8217;s &#8220;home country&#8221;), or under the rules of
          the home country exchange on which the registrant&#8217;s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant&#8217;s security holders, and, if discussing
          a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.</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="margin-top: 0.45pt; font-family: 'Times New Roman',Times,serif;"><br>
      </div>
      <div style="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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            <td colspan="1" style="width: 5%; padding-bottom: 2px;">&#160;</td>
            <td rowspan="1" colspan="2" style="text-indent: 32pt; border-bottom: 2px solid rgb(0, 0, 0);"><font style="font-family: 'Times New Roman',Times,serif;">FSD Pharma Inc.</font>&#160; <br>
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            <td colspan="1" style="width: 40%; text-indent: 32pt;">(Registrant) <br>
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            <td style="width: 5%; padding-bottom: 2px;">Date&#160; <br>
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            <td colspan="1" style="width: 45%; border-bottom: 2px solid rgb(0, 0, 0);">May 10, 2021 <br>
            </td>
            <td colspan="1" style="width: 5%; padding-bottom: 2px;">&#160;</td>
            <td colspan="1" style="width: 5%; padding-bottom: 2px; text-align: center;">By <br>
            </td>
            <td colspan="1" style="width: 40%; padding-bottom: 2px; text-indent: 24pt;">/s/ Raza Bokhari <br>
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            <td colspan="1" style="width: 5%; border-bottom: 2px solid rgb(0, 0, 0);">&#160;</td>
            <td colspan="1" style="width: 40%; text-indent: 32pt; border-bottom: 2px solid rgb(0, 0, 0);">(Signature) * <br>
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            <td rowspan="1" colspan="1" style="width: 5%;">&#160;</td>
            <td rowspan="1" colspan="2" style="text-indent: 32pt;">Raza Bokhari, Chief Executive Officer&#160; <br>
            </td>
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    __________________
    <div style="margin-top: 0.6pt; color: rgb(35, 31, 32); font-family: 'Times New Roman',Times,serif;">* Print the name and title under the signature of the signing officer.<font style="display: inline-block; width: 12pt;" id="TRGRRTFtoHTMLTab">&#160;</font></div>
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    <div style="text-align: center; margin-top: 0.05pt; font-family: 'Times New Roman',Times,serif;">EXHIBIT INDEX</div>
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            <div style="margin-top: 0.05pt;"><font style="font-family: 'Times New Roman',Times,serif;"><u>Exhibit</u></font></div>
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          <td colspan="1" style="width: 80%; text-align: left; vertical-align: bottom;"><font style="font-family: 'Times New Roman',Times,serif;"><u>Description</u></font> <br>
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          <td style="width: 20%; text-align: left; vertical-align: bottom;" rowspan="1"><a href="a52426277_ex991.htm">Exhibit 99.1</a> <br>
          </td>
          <td colspan="1" style="width: 80%; text-align: left; vertical-align: bottom;" rowspan="1"><a href="a52426277_ex991.htm">News Release dated May 10, 2021</a><br>
          </td>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a52426277_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>
  </div>
  <div style="text-align: right;"><font style="font-weight: bold;"> <br>
    </font></div>
  <div>
    <div class="bw-release">
      <h1 style="text-align: center; list-style-position: inside;FONT-SIZE: 14pt;"> <strong>FSD Pharma Announces Investigational New Animal Drug Filing With the FDA to Treat Dogs With Enteropathy </strong> </h1>
      <div class="bw-release-subhead">
        <ul style="list-style-type: disc;">
          <b>
            <li> <b><i>The FDA has accepted the Investigational new Animal Drug application for review</i></b> </li>
            <li> <b><i>The proposed trial is expected to be conducted at 5-10 sites in USA and will enroll up to 200 dogs</i></b> </li>
            <li> <b><i>Shareholders URGED to Vote the BLUE proxy by 9:00 a.m. on May 12, 2021</i></b> </li>
            <li> <b><i>Contact Gryphon Advisors Inc. for assistance at 1.833.292.5847 or by email at inquiries@gryphonadvisors.ca</i></b> </li>
          </b>
        </ul>
      </div>
      <div class="bw-release-body">
        <div class="bw-release-table-js bw-release-story">
          <p>TORONTO--(BUSINESS WIRE)--May 10, 2021--<b>FSD Pharma Inc. </b>(Nasdaq: HUGE) (CSE: HUGE.CN) (&#8220;<b>FSD Pharma</b>&#8221; or the &#8220;<b>Company</b>&#8221;)<b> </b>today announced that it has submitted to the U.S. Food and Drug Administration (&#8220;<b>FDA&#8221;</b>)
            an Investigational New Animal Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat Gastrointestinal enteropathy in dogs. The application has been accepted for review. </p>
          <p> <b>The proposed trial design is a randomized, double-blind, placebo-controlled, crossover, trial comparing FSD201 (ultramicronized Palmitoylethanolamide (PEA)) dosed twice daily for 30 days to placebo for the treatment of canine inflammatory
              bowel disease. The primary endpoint will be a validated diarrhea score, evaluated by both treating veterinarian and dog owner. The trial will be conducted at 5-10 sites in the USA, and will enroll up to 200 dogs.</b> </p>
          <p> <b>Vote Only the <u>BLUE</u> Proxy FOR the Management Director Nominees</b> </p>
          <p> FSD Pharma thanks shareholders for the strong support the Company has received ahead of its upcoming Annual and Special Meeting of Shareholders (the &#8220;Meeting&#8221;). </p>
          <p> On May 5, FSD Pharma announced that Institutional Shareholder Services Inc. (&#8220;ISS&#8221;), a leading independent international corporate governance analysis and proxy advisory firm, had recommended that shareholders vote FOR all Management Director
            Nominees i and FOR the elimination of the dual-class share structure (the "Dual-Class Sunset") at the Meeting. </p>
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          </div>
          <p> FSD Pharma urges shareholders to go to FSD Pharma&#8217;s website www.fsdfuture.com to cast their vote electronically and for additional information on how the Company has the right strategy and the right Management Director Nominees to build on
            its positive momentum towards value creation for all shareholders. Shareholders should contrast this plan with that of the Dissidents, whose self-serving approach pulls the Company backwards, making promises that are unlikely to materialize
            into real shareholder value creation. </p>
          <p> Shareholders are urged to vote immediately to ensure their proxies are received by the proxy voting deadline &#8211; no later than 9:00 a.m. (Toronto time) on May 12, 2021. Shareholders with questions or who require assistance voting their shares
            should contact the Company's proxy solicitation agent, Gryphon Advisors Inc. at 1.833.292.5847 toll-free in North America (1.416.902.5565 by collect call) or by email at inquiries@gryphonadvisors.ca. </p>
          <p> <b>Filing of Quarter-End Results</b> </p>
          <p> The Company also reported its reviewed financial results for the first quarter ended March 31, 2021. These filings are available for review under the Company's SEDAR profile at www.sedar.com. </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 over time multiple applications of its lead compound, ultramicro PEA by down-regulating the cytokines to effectuate
            an anti-inflammatory response. </p>
          <p> The Company filed an IND with the FDA on August 28, 2020 and was approved on September 25, 2020 to initiate a phase 2 clinical trial for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus. The trial is currently
            underway and is expected to randomize 352 patients in a controlled, double-blind multicenter study. </p>
          <p> Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. The Company is focused on developing ultra-micro PEA for its anti-inflammatory properties to avoid the
            cytokine storm associated with acute lung injury in hospitalized COVID-19 patients. </p>
          <p> The Company is not making any express or implied claim that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) infection at this time. </p>
          <p> <b>Forward-Looking Statements</b> </p>
          <p> Neither the Canadian Securities Exchange nor its regulation services provider accept responsibility for the adequacy or accuracy of this release. </p>
          <div> </div>
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          <p> The Company's subject area experts continue to review the scientific evidence/claims/research relevant to the application of PEA and ultramicronized-PEA. The company is not making any express or implied claims that its product has the ability
            to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time. </p>
          <p> The Phase 2 clinical trial program is subject to a favorable toxicology study and successful completion of ongoing laboratory studies, access to additional financing and review by the FDA of our IND application. The duration and cost of
            clinical trials can vary significantly depending on multiple factors, including the enrollment rate of patients, country in which trials are conducted, and specific trial protocols required. The process of developing pharmaceutical products and
            receiving the necessary regulatory approvals for commercialization typically takes several years. Accordingly, no near-term revenues from product sales or services are expected from our ultramicronized-PEA candidate(s). The milestones described
            above represent customary inflection points for financing by clinical-stage biotech companies. However, there is no assurance that the Company will be able to achieve these clinical milestones, nor, if successful in doing so, that the Company
            will be able to access additional financing on terms or timing acceptable to the Company. </p>
          <p> Certain statements contained in this press release constitute "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and U.S. securities laws (collectively, "Forward-Looking Information").
            Forward-Looking Information includes, but is not limited to, information with respect to FSD Pharma's strategy, plans or future financial or operating performance, receipt of any FDA approvals, including the approval of our IND submission, the
            completion of any trials regarding the use of FSD201 to treat COVID-19 or whether FSD201 may be effective in treating COVID-19, the costs associated with such planned trials, our ability to obtain required funding and the terms and timing
            thereof and the ultimate development of any FDA approved synthetic compounds. The use of words such as "budget", "intend", "anticipate", "believe", "expect", "plan", "forecast", "future", "target", "project", "capacity", "could", "should",
            "focus", "proposed", "scheduled", "outlook", "potential", "estimate" and other similar words, and similar expressions and statements relating to matters that are not historical facts, or statements that certain events or conditions "may" or
            "will" occur, are intended to identify Forward-Looking Information and are based on FSD Pharma's current beliefs or assumptions as to the outcome and timing of such future events. Such beliefs or assumptions necessarily involve known and
            unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such Forward Looking Information. Certain of these risks and uncertainties are described in the Company's continuous
            disclosure filings available under the Company's SEDAR profile at www.sedar.com and on the Company&#8217;s EDGAR profile at www.sec.gov. Forward Looking Information is not a guarantee of performance. The Forward-Looking Information contained in this
            press release is made as of the date hereof, and FSD Pharma is not obligated to update or revise any Forward-Looking Information, whether as a result of new information, future events or otherwise, except as required by law. Because of the
            risks, uncertainties and assumptions contained herein, investors should not place undue reliance on Forward Looking-Information. The foregoing statements expressly qualify any Forward-Looking Information contained herein. </p>
        </div>
        <div class="bw-release-contact">
          <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
          <p> <b>For further information:</b> </p>
          <p> <b>Investors: </b><br>
            Gryphon Advisors Inc. <br>
            1.833.292.5847 toll-free in North America <br>
            (1.416.902.5565 by collect call) <br>
            inquiries@gryphonadvisors.ca<br>
            www.fsdfuture.com </p>
          <p> Nathan Coyle, Interim Chief Financial Officer, FSD Pharma Inc. <br>
            ncoyle@fsdpharma.com </p>
          <p> <b>Media: </b><br>
            Joel Shaffer <br>
            Longview Communications and Public Affairs <br>
            jshaffer@longviewcomms.ca </p>
        </div>
      </div>
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