<SEC-DOCUMENT>0001183740-25-000008.txt : 20250108
<SEC-HEADER>0001183740-25-000008.hdr.sgml : 20250108
<ACCEPTANCE-DATETIME>20250107184641
ACCESSION NUMBER:		0001183740-25-000008
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20250107
FILED AS OF DATE:		20250108
DATE AS OF CHANGE:		20250107

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BRIGHT MINDS BIOSCIENCES INC.
		CENTRAL INDEX KEY:			0001827401
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			A1
		FISCAL YEAR END:			0930

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-40997
		FILM NUMBER:		25516120

	BUSINESS ADDRESS:	
		STREET 1:		19 VESTRY STREET
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10013
		BUSINESS PHONE:		6474072515

	MAIL ADDRESS:	
		STREET 1:		19 VESTRY STREET
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10013
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<TYPE>6-K
<SEQUENCE>1
<FILENAME>f6k-20250107im.htm
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<DIV style=margin-left:64.8pt;width:482.4pt><P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><B>UNITED STATES</B><BR><B>SECURITIES AND EXCHANGE COMMISSION</B><BR><B>Washington, D.C. &nbsp;20549</B></P>
<P align=center style='font:14pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><B>FORM 6-K</B></P>
<P align=center style='font:12pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><B>REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934</B></P>
<P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'>For the month of <B>January 2025</B></P>
<P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'>Commission File No. <B>001-40997</B></P>
<P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><FONT style='font-size:13pt;border-bottom:1px solid #000000'><B>BRIGHT MINDS BIOSCIENCES INC.</B></FONT><BR>(Translation of registrant's name into English)</P>
<P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><B>19 Vestry Street,</B><BR><FONT style='border-bottom:1px solid #000000'><B>New York, NY &nbsp;10013</B></FONT><BR>(Address of principal executive office)</P>
<P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'>Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F</P>
<P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><B>Form 20-F</B>&#160;&#160;<B>[ X ]</B> &nbsp;Form 40-F<B>&#160;&#160;[ &nbsp;]</B></P>
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<P align=center style='font:11pt Times New Roman;margin:0;background-color:#FFFFFF'><A name=_DV_M0 /><B>SUBMITTED HEREWITH</B></P>
<TABLE align=center style=border-collapse:collapse;width:475.45pt><TR><TD valign=top style=width:56.95pt><P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt;margin-left:5.4pt;color:#000000'><FONT style='border-bottom:1px solid #000000'><B>Exhibits</B></FONT></P>
</TD><TD valign=top style=width:418.5pt><P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt;margin-left:4.5pt;margin-right:7.65pt;color:#000000'>&nbsp;</P>
</TD></TR>
<TR><TD valign=top style=width:56.95pt><P style='font:11pt Times New Roman;margin-top:6pt;margin-bottom:6pt;margin-left:5.4pt;color:#000000'>99.1</P>
</TD><TD valign=top style=width:418.5pt><P style='font:11pt Times New Roman;margin-top:6pt;margin-bottom:6pt;margin-left:2.6pt;margin-right:1.95pt;color:#000000'><FONT style='color:#0000FF;border-bottom:1px solid #0000FF'><A href=ex991-20250107.htm style=text-decoration:none>News Release dated </A><A href=ex991-20250107.htm style=text-decoration:none>January 7, 2025</A></FONT></P>
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<DIV style=margin-left:72pt;width:468pt><HR style='border:0;height:0;width:0;margin:14pt 0 0 0'><P align=center style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'><B>SIGNATURE</B></P>
<P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'>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.</P>
<P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'>&nbsp;</P>
<P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt;margin-left:216pt'><B>BRIGHT MINDS BIOSCIENCES INC.</B></P>
<P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt;margin-left:216pt'><I>/s/ Ian McDonald</I><BR>__________________________<BR>Ian McDonald<BR>President and Chief Executive Officer</P>
<P style='font:11pt Times New Roman;margin-top:12pt;margin-bottom:0pt'>Date:  January 7, 2025</P>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex991-20250107.htm
<DESCRIPTION>NEWS RELEASE
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<DIV style=margin-left:72pt;width:468pt><P align=center style='font:14pt Calibri;margin-top:0pt;margin-bottom:8pt'><B>Bright Minds Biosciences Appoints Pharmaceutical Leader, Stephen Collins, M.D., Ph.D., as Chief Medical Officer</B></P>
<P align=center style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt;color:#000000'>-- Dr. Collins brings extensive drug development and clinical expertise in epilepsy --</P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>New York and Vancouver, BC &#8211;&nbsp;January 7, 2025 &#8211;&nbsp;Bright Minds Biosciences, Inc. (&#8220;Bright Minds,&#8221; &#8220;BMB&#8221; or the &#8220;Company&#8221;) (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, today announced that Stephen D. Collins, M.D., Ph.D., will join the Company as Chief Medical Officer (CMO), effective immediately. The Company also announces that Mark A. Smith M.D., Ph.D., will retire from his role as Acting CMO, but will continue to serve in an advisory capacity.</P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>&#8220;As Bright Minds continues to evolve its focus to address conditions with high unmet medical need, including epilepsy, depression, and other central nervous system (CNS) disorders, we are thrilled to welcome Dr. Collins at this pivotal time. Throughout his distinguished career as an R&amp;D leader, Steve has a demonstrated track record of leadership and strategic oversight from pre-clinical development through successful commercialization of several drugs across therapeutic areas. His experience advancing novel therapeutics in the CNS space aligns perfectly with our mission to develop the next generation of serotonin drugs to improve patient outcomes,&#8221; said Ian McDonald, CEO and Co-founder of Bright Minds Biosciences.</P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>&#8220;I am delighted to join the Bright Minds team and to continue investigating new chemical entities to treat rare epilepsies, an important and underserved area of therapeutics. With the recent initiation of the BREAKTHROUGH Study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101 in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE), I look forward to bringing my experience to guide the Company through its next phase of clinical development,&#8221; stated Dr. Collins.</P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>Prior to joining Bright Minds, Dr. Collins simultaneously served as CEO of Biscayne Neurotherapeutics, a small molecule clinical stage company focused on CNS disorders, and CEO and President of Biscayne Pharmaceuticals. Biscayne was sold to Supernus Pharmaceuticals in October of 2018 for future development. </P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>Before heading the two Biscayne companies, Dr. Collins held several top leadership positions at companies targeting CNS disorders, including as CEO of Neurotherapeutics Pharma and Chief Scientific Officer &amp; VP for Clinical Affairs of Ovation Pharmaceuticals, a CNS-focused biopharmaceutical company acquired by Lundbeck A/S for US $963 million. Three anti-convulsant therapies were developed and approved there, including Sabril for Infantile Spasms and Frisium for Lennox-Gastaut Syndrome. </P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>Prior to Ovation, Steve served as a Global Director at Johnson &amp; Johnson, overseeing early-stage development of a variety of CNS agents and as a member of the global in-licensing advisory team. Prior to Johnson and Johnson, he worked in Abbott Laboratories&#8217; Pharmaceutical and Hospital </P>
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<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>Products Divisions, where he developed drugs for a range of CNS indications, including Depakote, Depakote ER, Depacon, and Gabitril, as well as a range of older seizure medicines. He was responsible for all preclinical and clinical programs supporting the successful approval of multiple NDA and sNDA submissions. </P>
<P align=justify style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>Dr. Collins has served on several Boards of companies that have developed epilepsy drugs, including Spinifex Pharmaceuticals, which was acquired by Novartis, and Engage Therapeutics, which was sold to UCB S.A.</P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>Prior to industry, Dr. Collins served on the faculty of medicine at Case Western Reserve University and the University of California-San Francisco and was principal investigator or investigator on over 40 drug and device trials. He earned his MD and PhD at Case Western Reserve University after completing undergraduate studies in Biophysics at the University of California, Berkeley.</P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'><B>About Bright Minds Biosciences</B></FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients&#8217; lives.</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>Bright Minds Biosciences has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry.</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'> <B>About BMB-101</B></FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>BMB-101 is a novel scaffold 5-HT2CGq-protein biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively via the Gq-protein signaling pathway and avoids beta-arrestin activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. This provides a novel mechanism, anti-epileptic drug designed to provide sustained seizure relief in hard-to-treat patient populations. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of Dravet Syndrome and numerous models of generalized seizures.</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>In Phase 1 clinical studies, BMB-101 was demonstrated to be safe and well tolerated at all doses. No Serious Adverse Events (SAEs) were observed, and Adverse Events (AEs) were mild in nature and in line with on-target effects for serotonergic drugs. An extensive target-</FONT></P>
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<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed in this study which could indicate the potential for improved cognition.</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>On September 12th, Bright Minds Biosciences announced the initiation of the BREAKTHROUGH Study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'><B>Forward-Looking Statements</B><B> </B></FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>This news release contains &#8220;forward-looking information&#8221;. Often, but not always, forward-looking statements can be identified by the use of words such as &#8220;plans&#8221;, &#8220;expects&#8221;, &#8220;is expected&#8221;, &#8220;budget&#8221;, &#8220;scheduled&#8221;, &#8220;estimates&#8221;, &#8220;forecasts&#8221;, &#8220;intends&#8221;, &#8220;anticipates&#8221;, or &#8220;believes&#8221; or variations (including negative variations) of such words and phrases, or state 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 in this news release include progress, and completion of the BREAKTHROUGH Study, future clinical development of BMB-101, and future intended use or therapeutic benefit of BMB-101 to treat epilepsy disorders. &nbsp;A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company&#8217;s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company&#8217;s public filings under the Company&#8217;s SEDAR+ profile at www.sedarplus.ca. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management&#8217;s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.</FONT></P>
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<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'>The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'><B>Contact Information</B></FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>Alex Vasilkevich</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>Chief Operating Officer</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>Bright Minds Biosciences Inc.</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>T: 414-731-6422</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>E: alex@brightmindsbio.com</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>Website: www.brightmindsbio.com</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'><FONT style='font-family:Calibri'> </FONT>&nbsp;</P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>Investor Relations</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>Lisa M. Wilson</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>T: 212-452-2793</FONT></P>
<P style='font:12pt Calibri;margin:0'><FONT style='font-family:Calibri'>E: lwilson@insitecony.com</FONT></P>
<P style='font:12pt Calibri;margin-top:0pt;margin-bottom:8pt'>&nbsp;</P>
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