Press Release: Psyence Group’s NASDAQ Listed Associate, Psyence Biomedical Partners with Fluence and iNGENū CRO to Train Research Therapists for Phase IIb Psilocybin Trial

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) — Psyence Group Inc (“Psyence Group“) (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ listed associate, Psyence Biomedical Ltd (NASDAQ: PBM) (“PBM” or “Psyence Biomed“), has announced that its Australian subsidiary, Psyence Australia Pty Ltd (“Psyence Australia“), has entered into a partnership with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū“), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.

According to a news release issued by PBM on April 8, 2024, Fluence’s highly credentialed and widely published faculty members are recognized as the global experts in professional psychedelic therapy education; psychiatrists, psychologists, psychotherapists, physicians, and nurse practitioners have completed its comprehensive certification programs. Fluence is authorized by the American Psychological Association (APA), the National Association of Social Workers (NASW), and other professional organizations as a provider of professional continuing education for clinicians.

“We are very pleased with the progress being made by PBM, and the recent partnership with Fluence shows that the management team has maintained the momentum of the Psyence Biomed business following the implementation of the January 2024 business combination and is executing on its strategy,” said Jody Aufrichtig, Executive Chairman of the board of Psyence Group.

Dr Clive Ward-Able, MD, Psyence Biomed’s Chief Medical Officer is quoted as saying: “Fluence brings unparalleled expertise in psychedelic therapy training to the collaboration,” going on to say that: “[PBM] expect[s] that Fluence’s participation in this trial will ensure both quality of care for patients and also significantly contribute to the critical body of research needed to evaluate how best to integrate psychedelic-assisted therapy for cancer patients into the standard of care for palliative medicine.“

The double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. According to the news release, Psyence Biomed anticipates enrolling the first patient subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.

Psyence Group holds 5,000,000 common shares in PBM, equal to an approximate minority interest in PBM of 37%.

About Psyence Group and Psyence Biomed:

Psyence Group is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG), with a focus on natural psychedelics. Psyence Biomed is the world’s first life science biotechnology company traded on the Nasdaq (NASDAQ: PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines, and works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.

Informed by nature and guided by science, Psyence Group has built and operates one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development. We work to develop advanced natural psilocybin products for clinical research and development.

Learn more at www.psyence.com and on Twitter, Instagram and LinkedIn.

About Fluence
Fluence is the global leader in providing comprehensive, evidence-based training in psychedelic therapy and integration to healthcare professionals. With a mission to equip clinicians with the clinical skills and knowledge necessary for effective, evidence-based psychedelic therapy and integration services, Fluence offers ethical, dynamic, interactive training both online and in-person. Since its inception, Fluence has educated over 7,000 practitioners, establishing itself as a frontrunner in psychedelic therapy training for private enterprises and research organizations.

About iNGENū
iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. iNGENū’s core mission is to create access to high quality clinical research globally by removing financial and other unnecessary barriers. iNGENū is a physician-led, full-service CRO with in-house access to an established network of clinical trial research professionals.