Scientific Advisory Board will bring significant expertise in psilocybin research and clinical trial design
NEW YORK, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced that it will work closely with Albert P. Garcia-Romeu, Ph.D., to chair and develop its newly created Scientific Advisory Board (SAB).
Dr. Garcia-Romeu is a leading psychedelics researcher currently serving as Associate Professor in the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, as well as Associate Director, Johns Hopkins Center for Psychedelic and Consciousness Research and the Susan Hill Ward Professor in Psychedelics and Consciousness. He is a highly sought after speaker on the therapeutic potential of psilocybin, with a particular emphasis on substance use disorder, and has been extensively published. Dr. Garcia-Romeu has also served as co-investigator and co-primary investigator for numerous psilocybin clinical trials.
“With the imminent randomization of the first patient into our Pallicybin Phase IIb clinical trial of psilocybin as a potential treatment for Adjustment Disorder in Palliative Care, we welcome Dr. Garcia-Romeu, who brings invaluable expertise to our SAB as both a psilocybin researcher and clinical trial investigator,” stated Dr. Neil Maresky, M.B.,B.Ch., Chief Executive Officer of Psyence Biomed. “We will rely heavily on Dr. Garcia-Romeu’s experience as we design the optimal Phase III program in Adjustment Disorder while in parallel advancing preparations for our second development indication in Alcohol Use Disorder.”
The Company will continue to recruit additional members for its SAB, which also includes Dr. Clive Ward Able, Medical Director of Psyence Biomedical, and Dr. Seth Feuerstein, Department of Psychiatry at Yale University.
“I am excited to join Psyence Biomed’s Scientific Advisory Board as the company works to introduce a new class of psychedelic-based therapeutics to treat a range of conditions in mental health and addiction,” stated Dr. Garcia-Romeu. “The two indications that PBM are developing are both areas that have not had much attention paid to them by the pharmaceutical industry and psychedelics have already shown promise in treating both conditions.”
About Psyence Biomed: Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few vertically integrated biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. The first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, FDA-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders.
Forward Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the progress of the Phase IIb clinical trial and preparations for the Company's second development indication. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule and patient recruitment, and that data from trials in Adjustment Disorder and Alcohol Use Disorder will remain positive. There can be no assurance that the Company will continue to maintain compliance with Nasdaq’s continued listing requirements.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Company’s final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the “SEC”) on January 24, 2025 and other documents filed by Psyence Biomed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence Biomed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
