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Psyence Biomed Names Albert P. Garcia-Romeu, Ph.D. as Chair of its Newly Created Scientific Advisory Board

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Psyence Biomedical (Nasdaq: PBM) has appointed Dr. Albert P. Garcia-Romeu as Chair of its newly established Scientific Advisory Board (SAB). Dr. Garcia-Romeu, currently Associate Professor at Johns Hopkins University School of Medicine and Associate Director of the Johns Hopkins Center for Psychedelic and Consciousness Research, brings extensive expertise in psilocybin research and clinical trials.

The appointment comes as the company prepares for the randomization of its first patient in the Pallicybin Phase IIb clinical trial, investigating psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The company is also advancing preparations for a second development indication in Alcohol Use Disorder.

The SAB currently includes Dr. Clive Ward Able, Medical Director of Psyence Biomedical, and Dr. Seth Feuerstein from Yale University's Department of Psychiatry, with plans to recruit additional members.

Psyence Biomedical (Nasdaq: PBM) ha nominato il Dr. Albert P. Garcia-Romeu come Presidente del suo nuovo Comitato Consultivo Scientifico (SAB). Il Dr. Garcia-Romeu, attualmente Professore Associato presso la Johns Hopkins University School of Medicine e Direttore Associato del Johns Hopkins Center for Psychedelic and Consciousness Research, porta con sé una vasta esperienza nella ricerca e nelle sperimentazioni cliniche sulla psilocibina.

La nomina avviene mentre l'azienda si prepara alla randomizzazione del suo primo paziente nel trial clinico Pallicybin Phase IIb, che indaga sulla psilocibina come potenziale trattamento per il Disturbo di Adattamento nella Cure Palliative. L'azienda sta anche avanzando nei preparativi per una seconda indicazione di sviluppo nel Disturbo da Uso di Alcol.

Il SAB include attualmente il Dr. Clive Ward Able, Direttore Medico di Psyence Biomedical, e il Dr. Seth Feuerstein del Dipartimento di Psichiatria dell'Università di Yale, con piani per reclutare ulteriori membri.

Psyence Biomedical (Nasdaq: PBM) ha nombrado al Dr. Albert P. Garcia-Romeu como Presidente de su recién establecido Consejo Asesor Científico (SAB). El Dr. Garcia-Romeu, actualmente Profesor Asociado en la Escuela de Medicina de la Universidad Johns Hopkins y Director Asociado del Centro de Investigación Psicodélica y de la Conciencia de Johns Hopkins, aporta una amplia experiencia en la investigación y ensayos clínicos de psilocibina.

La designación se produce mientras la empresa se prepara para la aleatorización de su primer paciente en el ensayo clínico Pallicybin Phase IIb, que investiga la psilocibina como un posible tratamiento para el Trastorno de Ajuste en Cuidados Paliativos. La empresa también está avanzando en los preparativos para una segunda indicación de desarrollo en el Trastorno por Uso de Alcohol.

El SAB incluye actualmente al Dr. Clive Ward Able, Director Médico de Psyence Biomedical, y al Dr. Seth Feuerstein del Departamento de Psiquiatría de la Universidad de Yale, con planes de reclutar miembros adicionales.

사이언스 바이오메디컬 (Nasdaq: PBM)은 알버트 P. 가르시아-로메우 박사를 새로 설립된 과학 자문 위원회(SAB)의 의장으로 임명했습니다. 가르시아-로메우 박사는 현재 존스 홉킨스 대학교 의과대학의 부교수이자 존스 홉킨스 정신과 및 의식 연구 센터의 부소장으로, 실로시빈 연구 및 임상 시험에 대한 폭넓은 전문 지식을 보유하고 있습니다.

이번 임명은 회사가 팔리시빈 2b 임상 시험에서 첫 번째 환자의 무작위 배정을 준비하는 가운데 이루어졌으며, 이는 완화 치료에서 조정 장애에 대한 잠재적 치료제로서 실로시빈을 조사하고 있습니다. 회사는 또한 알코올 사용 장애에 대한 두 번째 개발 적응증 준비를 진행하고 있습니다.

SAB에는 현재 사이언스 바이오메디컬의 의료 책임자인 클라이브 워드 에이블 박사와 예일 대학교 정신과의 세스 파이어스타인 박사가 포함되어 있으며, 추가 회원을 모집할 계획입니다.

Psyence Biomedical (Nasdaq: PBM) a nommé le Dr. Albert P. Garcia-Romeu comme Président de son nouveau Conseil Consultatif Scientifique (SAB). Le Dr. Garcia-Romeu, actuellement Professeur Associé à la Johns Hopkins University School of Medicine et Directeur Associé du Johns Hopkins Center for Psychedelic and Consciousness Research, apporte une vaste expertise dans la recherche et les essais cliniques sur la psilocybine.

Cette nomination intervient alors que l'entreprise se prépare à la randomisation de son premier patient dans l', qui examine la psilocybine comme un traitement potentiel pour le Trouble d'Adaptation en Soins Palliatifs. L'entreprise avance également dans les préparatifs pour une deuxième indication de développement dans le Trouble de l'Usage de l'Alcool.

Le SAB comprend actuellement le Dr. Clive Ward Able, Directeur Médical de Psyence Biomedical, et le Dr. Seth Feuerstein du Département de Psychiatrie de l'Université de Yale, avec des plans pour recruter des membres supplémentaires.

Psyence Biomedical (Nasdaq: PBM) hat Dr. Albert P. Garcia-Romeu zum Vorsitzenden seines neu gegründeten Wissenschaftlichen Beirats (SAB) ernannt. Dr. Garcia-Romeu ist derzeit außerordentlicher Professor an der Johns Hopkins University School of Medicine und stellvertretender Direktor des Johns Hopkins Center for Psychedelic and Consciousness Research und bringt umfangreiche Erfahrung in der Forschung und klinischen Studien zu Psilocybin mit.

Die Ernennung erfolgt, während das Unternehmen sich auf die Randomisierung seines ersten Patienten in der Pallicybin Phase IIb-Studie vorbereitet, die Psilocybin als potenzielle Behandlung für Anpassungsstörungen in der Palliativversorgung untersucht. Das Unternehmen arbeitet auch an den Vorbereitungen für eine zweite Entwicklungsindikation bei Alkoholgebrauchsstörungen.

Der SAB umfasst derzeit Dr. Clive Ward Able, medizinischer Direktor von Psyence Biomedical, und Dr. Seth Feuerstein von der Psychiatrischen Abteilung der Yale-Universität, mit dem Plan, weitere Mitglieder zu rekrutieren.

Positive
  • Appointment of renowned psilocybin researcher as SAB Chair
  • Phase IIb clinical trial reaching patient randomization stage
  • Development pipeline includes two distinct therapeutic indications
  • Strong academic expertise on Scientific Advisory Board
Negative
  • Both targeted conditions lack significant pharmaceutical industry attention
  • Clinical trials still in early/mid-stage phases

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.

Learn more at www.psyencebiomed.com and on LinkedIn.

Contact Information for Psyence Biomedical Ltd.
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708

Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com

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.


FAQ

What is the focus of Psyence Biomedical's (PBM) Phase IIb clinical trial?

PBM's Phase IIb trial is testing Pallicybin (psilocybin) as a potential treatment for Adjustment Disorder in Palliative Care patients.

Who are the current members of Psyence Biomedical's (PBM) Scientific Advisory Board?

The SAB includes Dr. Albert Garcia-Romeu as Chair, Dr. Clive Ward Able as Medical Director, and Dr. Seth Feuerstein from Yale University.

What are the two main development indications for Psyence Biomedical (PBM)?

PBM is developing treatments for Adjustment Disorder in Palliative Care and Alcohol Use Disorder.

What is Dr. Garcia-Romeu's current role at Johns Hopkins University?

He serves as Associate Professor in Psychiatry and Behavioral Sciences and Associate Director of the Center for Psychedelic and Consciousness Research.

Psyence Biomedical Ltd.

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