<SEC-DOCUMENT>0001157523-21-000348.txt : 20210317
<SEC-HEADER>0001157523-21-000348.hdr.sgml : 20210317
<ACCEPTANCE-DATETIME>20210317060110
ACCESSION NUMBER:		0001157523-21-000348
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20210316
FILED AS OF DATE:		20210317
DATE AS OF CHANGE:		20210317

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:		21748329

	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>a52397247.htm
<DESCRIPTION>FSD PHARMA INC. FORM 6-K
<TEXT>
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      <div style="text-align: center; margin-right: 14.2pt; margin-left: 16.3pt; margin-top: 4.55pt; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">UNITED STATES</div>
      <div style="text-align: center; margin-right: 14.1pt; margin-left: 16.3pt; margin-top: 0.5pt; 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; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">Washington, D.C. 20549</div>
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      <div style="text-align: center; margin-right: 13.3pt; margin-left: 16.3pt; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">Form 6-K</div>
      <div style="text-align: center; margin-right: 13.75pt; margin-left: 16.3pt; margin-top: 12.9pt; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
        UNDER THE SECURITIES EXCHANGE ACT OF 1934</div>
      <div style="margin-top: 0.35pt;"><br>
      </div>
      <div style="margin-right: 277.15pt; margin-left: 8.25pt;">For&#160; the month of<u>&#160; &#160; &#160; &#160; &#160; March&#160; &#160; &#160; &#160; &#160; &#160;&#160; </u>, 20<u>&#160; &#160;&#160; 21</u><font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; font-size: 1px; width: 265.95pt">&#160;</font>. Commission File Number <u>&#160; &#160; 001-39152</u><font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; font-size: 1px; width: 12pt">&#160;</font></div>
      <div style="text-align: center; margin-top: 0.45pt;"><font style="font-size: 16pt;">FSD PHARMA INC.</font>
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      <div style="text-align: center; margin-right: 13.85pt; margin-left: 16.3pt;">(Translation of registrant&#8217;s name into English)</div>
      <div><br>
      </div>
      <div style="text-align: center; margin-top: 0.35pt;">First Canadian Place, 100 King Street West, Suite 3400, Toronto, ON M5X 1A4, Canada
        <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; margin-left: auto; margin-right: auto; border: none;"></div>
      <div style="text-align: center; margin-right: 13.6pt; margin-left: 16.3pt;">(Address of principal executive office)</div>
      <div style="margin-top: 0.35pt;"><br>
      </div>
      <div style="margin-right: 52.7pt; margin-left: 8.25pt; margin-top: 0.05pt;">Indicate by
          check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font>&#160;Form 40-F &#9746;</div>
      <div style="margin-right: 52.7pt; margin-left: 8.25pt; margin-top: 0.05pt;"> <br>
      </div>
      <div style="font-family: 'Times New Roman',Times,serif; margin-left: 18pt;">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 style="margin-top: 0.3pt;"><br>
      </div>
      <div style="margin-left: 8.25pt; margin-top: 0.05pt;"><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 style="margin-left: 8.25pt; margin-top: 9.65pt;">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): <font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; font-size: 1px; width: 12pt">&#160;</font></div>
      <div style="margin-top: 0.45pt;"><br>
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      <div style="margin-right: 8.3pt; margin-left: 8.25pt; margin-top: 4.6pt;"><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; margin-right: 14.45pt; margin-left: 16.3pt; font-weight: bold;">SIGNATURES</div>
      <div style="margin-top: 0.45pt;"><br>
      </div>
      <div style="text-indent: 18pt; margin-left: 8.25pt;">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;FSD Pharma Inc.</div>
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          <td valign="top" align="left" style="width: 35%;" rowspan="1">&#160;(Registrant)</td>
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            <div align="left" style="margin-left: 0pt; text-indent: 0pt; margin-right: 0pt">Date&#160;&#160;&#160; March 16, 2021</div>
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            <div align="left" style="margin-left: 0pt; text-indent: 0pt; margin-right: 0pt">/s/ Donal Carroll</div>
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            <div align="justify">Donal Carroll, Chief Financial Officer</div>
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      EXHIBIT INDEX</div>
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                <div style="text-align: left; margin-right: 7.35pt; margin-top: 0.05pt;"><u>Exhibit</u><font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; font-size: 1px; width: 144pt">&#160;</font></div>
              </div>
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              <div>&#160;<u>Description</u></div>
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                <div style="text-align: left; margin-right: 7.35pt; margin-top: 0.05pt;"><a href="a52397247ex99_1.htm">Exhibit 99.1<font id="TRGRRTFtoHTMLTab" style="display: inline-block; text-indent: 0px; font-size: 1px; width: 144pt"> <br>
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              <div>&#160;</div>
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              <div><a href="a52397247ex99_1.htm">&#160;News Release dated March 16, 2021</a></div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a52397247ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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            <div style="text-align: right;">&#160;Exhibit 99.1</div>
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      <div class="bw-release">
        <h1 style="text-align: center; list-style-position: inside;FONT-SIZE: 14pt;font-weight:normal;"> <b>FSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases in Dogs and Cats</b>
        </h1>
        <div class="bw-release-subhead">
          <p style="text-align: center; list-style-position: inside;font-weight:normal;"><b> <b>-Announces Filing of Year-End 2020 Results and Provides Corporate Update</b> </b></p>
        </div>
        <div class="bw-release-body">
          <div class="bw-release-table-js bw-release-story">
            <p>TORONTO--(BUSINESS WIRE)--March 16, 2021--FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) (&#8220;FSD Pharma&#8221; or the &#8220;Company&#8221;) today announces that it has entered into a license agreement (the &#8220;License Agreement&#8221;) with Innovet Italia S.R.L.
              (&#8220;Innovet&#8221;), under which Innovet granted the Company a license to use ultramicronized-palmitoylethanolamide (or ultramicronized PEA) (&#8220;ultra-micro PEA&#8221;) to develop U.S. Food and Drug Administration (&#8220;FDA&#8221;) approved veterinary drugs for the
              treatment of gastro-intestinal diseases in Canine and Feline (Dogs and Cats). In addition, the Company today announces the filing of its year-end results and provides corporate updates. </p>
            <p> &#8220;The licensing agreement with Innovet Italia S.R.I, to evaluate the use of ultra- micro PEA as a veterinary anti-inflammatory prescription drug, is an exciting opportunity for the company to enter into a new and untapped market,&#8221; said Dr.
              Raza Bokhari, Executive Chairman &amp; CEO. &#8220;With a balance sheet that is stronger today than it was when we began our journey nearly three years ago, we are actively exploring other M&amp;A and licensing opportunities to expand our drug
              development pipeline.&#8221; </p>
            <p> <b>License Agreement</b> </p>
            <p> The License Agreement grants the Company an exclusive, worldwide license (excluding Italy, and subject to a first refusal right maintained by Innovet, any other country in Europe) to research, manufacture and commercialize products using
              certain proprietary formulations of ultra-micro PEA (the &#8220;Licensed Products&#8221;) to treat gastro-intestinal diseases in canines and felines. The License Agreement provides that the Company shall develop the Licensed Products with a view to
              submitting an Investigational Animal Drug Application with the FDA within thirty-six (36) months of the date of the agreement and shall submit a New Animal Drug Application within sixty (60) months of the effective date of the agreement. </p>
            <p> Under the terms of the License Agreement, the Company is required to make payments to Innovet upon the achievement of specified milestones. An initial non-refundable sum of US$500,000 is due and payable to Innovet on the effective date of
              the License Agreement and a second non-refundable sum of US$250,000 will be due and payable to Innovet on the first anniversary of the effective date of the License Agreement. Within thirty business days of the first notification of approval
              of a New Animal Drug Application by the FDA of the first Licensed Product to receive such approval in the United States, the Company is required to pay an additional non-refundable sum of US$750,000 to Innovet. </p>
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            </div>
            <p> The License Agreement also specifies certain royalty payments. Pursuant to the License Agreement, the Company is required to pay Innovet 14% of any one-off lump sum payments it receives as consideration for granting a sub-license to a
              third-party with respect to a Licensed Product. In addition, the Company is required to pay 5% of net sales of the Licensed Products. </p>
            <p> The above description of the License Agreement is qualified in its entirety by reference to the full text of such agreement, a copy of which will be available under the Company&#8217;s SEDAR and EDGAR profiles. </p>
            <p> <b>Corporate Update</b> </p>
            <p> The Company's annual and special meeting of shareholders for 2021 ("<b>2021 AGM</b>") has been scheduled for May 14, 2021. April 15, 2021 has been fixed as the record date for voting at the 2021 AGM. The Company's management information
              circular and related proxy materials will be delivered to shareholders and made available under the Company's SEDAR profile on or before April 23, 2021. This 2021 AGM is being held in lieu of Annual meeting of the Shareholders meeting
              announced earlier for June 29<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">th</sup> 2021. </p>
            <p> The Company also has recently retained Randell J Mack, a veteran pharmaceutical executive as President of FSD BioSciences, Inc. Dr. Edward Brennan, has been named the Chief Medical Officer. </p>
            <p> <b>Filing of Year-End Results</b> </p>
            <p> The Company also reported its audited financial results for the fourth quarter and full year ended December 31, 2020. 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, ultra-micro 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>
            <div> </div>
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            <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>About Innovet </b> </p>
            <p> Innovet Italia is an innovative animal health company, founded in Italy in 1996. Its main goal is to bring scientific innovation in niche fields of the veterinary market. The philosophy that drives Innovet's development is to follow where
              nature leads, studying and mimicking natural protective body responses rather than "artificially" fighting the mechanisms of diseases. Based on such a strategic idea, Innovet's research team discovered and patented a family of bioactive lipid
              amides (i.e., aliamides, whose parent compound is palmitoylethanolamide, PEA) able to naturally restore the physiological balance of the hyper-reactive tissues. PEA, its micronized and ultramicronized forms and various other congeners, are
              the main components of Innovet's innovative products. Innovet's commercial effort is mainly focused on the small animal health field, in many market segments (i.e. dermatology, orthopedics, oral health, uro-nephrology, behavior,
              gastroenterology, ophthalmology and algology). For more information: http://www.innovet.it </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 press release. </p>
            <p> Certain statements contained in this press release constitute &#8220;forward-looking information&#8221; and &#8220;forward-looking statements&#8221; within the meaning of applicable Canadian and U.S. securities laws (collectively, &#8220;Forward-Looking Information&#8221;).
              Forward-Looking Information includes, but is not limited to, information with respect to FSD Pharma&#8217;s strategy, plans or future financial or operating performance, receipt of any FDA or other regulatory approvals, the completion of any trials
              regarding the use of FSD201 to treat COVID-19 or to treat canine and feline gastro-intestinal diseases, the safety of FSD201 or whether FSD201 may be effective in treating COVID-19 or to treat canine and feline gastro-intestinal diseases, the
              costs associated with such planned trials and our belief that we have sufficient cash to complete any clinical trials or studies with respect to the foregoing, our ability to obtain required funding and the terms and timing thereof. The use
              of words such as &#8220;budget&#8221;, &#8220;intend&#8221;, &#8220;anticipate&#8221;, &#8220;believe&#8221;, &#8220;expect&#8221;, &#8220;plan&#8221;, &#8220;forecast&#8221;, &#8220;future&#8221;, &#8220;target&#8221;, &#8220;project&#8221;, &#8220;capacity&#8221;, &#8220;could&#8221;, &#8220;should&#8221;, &#8220;focus&#8221;, &#8220;proposed&#8221;, &#8220;scheduled&#8221;, &#8220;outlook&#8221;, &#8220;potential&#8221;, &#8220;estimate&#8221; and other similar
              words, and similar expressions and statements relating to matters that are not historical facts, or statements that certain events or conditions &#8220;may&#8221; or &#8220;will&#8221; occur, are intended to identify Forward-Looking Information and are based on FSD
              Pharma&#8217;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&#8217;s continuous disclosure filings available under the Company&#8217;s SEDAR profile at www.sedar.com and under 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>
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          <div class="bw-release-contact">
            <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
            <p> Donal Carroll, Chief Financial Officer, FSD Pharma Inc. <br>
              Dcarroll@fsdpharma.com </p>
            <p> <b>Investor Relations </b><br>
              IR@fsdpharma.com </p>
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