Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG)
(“
Bright Minds” or the
“
Company”), 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 the expansion of its
Scientific Advisory Board (SAB) to include five distinguished
experts in epilepsy research:
- Dennis Dlugos, MD, MSCE
- Jacqueline French, MD
- Terrence O'Brien, MD
- Jo Sourbron, MD, PhD, MPharm
- Joseph Sullivan, MD
“The addition of these five esteemed scientists
to our SAB reflects our deepening clinical focus on epilepsy.
Together with our current SAB members, their expertise will be
invaluable as we continue our Phase 2 BREAKTHROUGH study of BMB-101
in adult patients with classic Absence Epilepsy and Developmental
Epileptic Encephalopathy (DEE). Their cumulative experience
advising on clinical trials across numerous epilepsy and related
brain diseases, both in pediatric and adult patient populations,
will help shape our trajectory as we seek to advance our pipeline
of product candidates,” said Stephen Collins, Chief Medical Officer
of Bright Minds Biosciences.
“We are fortunate to welcome these accomplished
and highly respected researchers to the Bright Minds team at this
exciting juncture. As we advance our clinical programs through the
regulatory process, their perspectives and real-world experience
will provide important guidance around our development efforts.
Epilepsy affects more than 70 million people worldwide, and we are
committed to pursuing therapies that reduce seizure frequency and
improve the quality of life for patients with drug-resistant
epilepsy,” said Ian McDonald, CEO and Co-founder of Bright Minds
Biosciences.
Dennis J. Dlugos, MD, MSCE, is
Professor of Neurology and Pediatrics at the University of
Pennsylvania; and Director, Pediatric Epilepsy Program at
Children’s Hospital of Philadelphia (CHOP). Dr. Dlugos currently
serves as a Vice-President of the Epilepsy Study Consortium,
Incorporated (ESCI). As Vice-President, he coordinates reviews and
adjudications for pediatric epilepsy trials and participated in
discussions with FDA regarding extrapolation of efficacy for
focal-onset seizures to one-month to age, and the validity of
Developmental and Epileptic Encephalopathy broadly (DEE Other) as a
clinical indication for pivotal trials and FDA labelling. Dr.
Dlugos is also a member of AES and the Pediatric Epilepsy Research
Consortium (PERC). He received his MD from Columbia University
College of Physicians and Surgeons, New York. He completed his
internship in Pediatrics at the National Naval Medical Center,
Bethesda, Maryland; residency in Neurology-Child Neurology at the
University of Pennsylvania/CHOP; and Epilepsy fellowship at CHOP.
Articles authored or co-authored by Dr. Dlugos have been published
in Neurology, Annals of Neurology, Lancet Neurology, Epilepsia,
Lancet, Nature, the New England Journal of Medicine, and other
journals.
Jacqueline French, MD, is a
professor of Neurology in the Comprehensive Epilepsy Center at NYU
Grossman School of Medicine and Founder/Director of the Epilepsy
Study Consortium, an academic group that has performed a number of
early phase epilepsy trials. Dr. French trained in Neurology at
Mount Sinai Hospital in New York and did her fellowship at Mount
Sinai hospital and Yale University. Dr. French serves as the
Medical Director of the Epilepsy Foundation. She is the past
president of the American Epilepsy Society. She has authored over
300 articles and chapters, and lectures internationally on use of
antiseizure medicines.
Terence J. O’Brien, MD, is
Chair of Medicine (Neurology) and Head, The School of Translational
Medicine, Monash University and Program Director, Alfred Brain and
Deputy Director of Research, Alfred Health. He is a specialist in
neurology and clinical pharmacology, with particular expertise in
epilepsy and neurodegenerative diseases, pre-clinical and clinical
trials, and in-vivo imaging in animal models and humans. He leads a
large translational research team undertaking both basic studies
and clinical studies focused on developing improved treatments for
people with epilepsy and related brain diseases, including
traumatic brain injury, dementias and brain tumors. He has
published >850 peer-reviewed original papers which have been
highly cited (>42,000 times GS). He has been a PI on >200
clinical trials, including 8 that have been translated from his
basic discovery research program. He has received 18 research
awards from national and international scientific bodies.
Dr. Jo Sourbron, MD, PhD,
MPharm, is a physician scientist with a clinical practice
at the University Hospitals of Ghent (UZ Ghent, Belgium) and a
postdoctoral researcher at the University of Leuven (UZ/KU Leuven,
Belgium). Dr. Sourbron has a special interest in genetic forms of
epilepsy and clinical trials for drug-resistant forms of epilepsy.
He has been a preclinical researcher for over a decade, focused on
finding novel serotonergic (5-HT) compounds for drug-resistant
epilepsies. Dr. Sourbron has explored the efficacy and safety of a
variety of anti-epileptic drugs including, 5-HT2 agonists like
fenfluramine and lorcaserin in various animal models. For the past
five years, he has been particularly involved in research involving
epilepsy with eyelid myoclonia (EEM) with prominent photic
induction (Sunflower syndrome). Concomitantly, he was involved in
the pilot clinical trial of fenfluramine in Sunflower syndrome
patients. Finally, he participated in several other clinical trials
for drug-resistant epilepsies, such as cannabidiol in the treatment
of drug-resistant epileptic disorders.
Joseph Sullivan, MD, is a
professor of neurology and pediatrics at the University of
California, San Francisco (UCSF) and director of the UCSF Pediatric
Epilepsy Center of Excellence at Benioff Children’s Hospital. He
has served as principal investigator for numerous clinical trials
in pediatric epilepsy and has a particular interest in Dravet
syndrome and PCDH19 related epilepsy. He completed a pediatric
residency at the Ann & Robert H. Lurie Children’s Memorial
Hospital of Northwestern University in Chicago, where he spent an
additional year as pediatric chief resident. He then completed his
neurology, child neurology and epilepsy training at the Hospital of
the University of Pennsylvania and at The Children’s Hospital of
Philadelphia, both in Philadelphia, before taking his first faculty
position at UCSF in 2007. He currently serves on the Board of
Directors and medical advisory board for the Dravet Syndrome
Foundation and is chair of the PCDH19 Alliance scientific advisory
board.
Drs. Dlugos, French, O'Brien, Sourbron, and
Sullivan join the Company’s current SAB members, Michael P.
Bogenschutz, MD, Robert C. Malenka, MD, PhD, Herbert Y. Meltzer,
MD, and Dr. Peter Hendricks, PhD.
Grant of Equity Incentive
Awards
The Company has granted stock options (the
“Options”) to certain directors, officers and
consultants of the Company to purchase an aggregate 161,000 common
shares (the “Shares”) in the capital of the
Company pursuant to the Company’s share option plan and 600
Restricted Stock Units (the “RSUs”). The Options
are exercisable at an exercise price of US$35.00 per Share for a
period of four (4) years from the date of grant. The Options are
subject to vesting periods over the course of the term of the
Options.
About Bright Minds
Bright Minds 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' lives.
Bright Minds 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.
Forward-Looking Statements
This news release contains “forward-looking
information”. Often, but not always, forward-looking statements can
be identified by the use of words such as “plans”, “expects”, “is
expected”, “budget”, “scheduled”, “estimates”, “forecasts”,
“intends”, “anticipates”, or “believes” or variations (including
negative variations) of such words and phrases, or state that
certain actions, events or results “may”, “could”, “would”, “might”
or “will” 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. 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’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’s public filings under the Company’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’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.
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.
Contact Information
Alex VasilkevichChief Operating OfficerBright Minds
Biosciences Inc.T: 414-731-6422E: alex@brightmindsbio.comWebsite:
www.brightmindsbio.com
Investor Relations
Lisa M. WilsonT: 212-452-2793E:
lwilson@insitecony.com
The securities of the Company referred to in
this news release have not been and will not be registered under
the United States Securities Act of 1933, as amended (the
“U.S. Securities Act”), or any state securities
laws. Accordingly, the securities of the Company may not be offered
or sold within the United States unless registered under the U.S.
Securities Act and applicable state securities laws or pursuant to
an exemption from the registration requirements of the U.S.
Securities Act and applicable state securities laws. This news
release does not constitute an offer to sell or a solicitation of
any offer to buy any securities of the Company in any jurisdiction
in which such offer, solicitation or sale would be unlawful.
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