NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced that it has progressed beyond the previously-announced non-binding Letter of Intent (LOI) and executed binding agreements with Optimi Health Corp. Under the terms of the agreements, Optimi becomes the exclusive supplier of GMP-certified, nature-derived (non-synthetic) psilocybin extract for Psyence’s global drug development and commercialization initiatives for FDA-approved uses in the Palliative Care context.
Optimi will provide comprehensive Chemistry, Manufacturing, and Control (“CMC”) support for regulatory submissions related to Psyence’s clinical trials in Palliative Care and any future Investigational New Drug (“IND”) applications. Psyence will obtain exclusive rights to Optimi’s drug candidate for treatment use in the Palliative Care context.
Dane Stevens, Chief Executive Officer of Optimi Health, stated, “We are very excited to have the opportunity to support Psyence Biomed as it works toward the potential initiation of pivotal registrational Phase III studies in Adjustment Disorder. As psychedelic research and development activities gain traction globally, we strive to be the partner-of-choice for companies like Psyence Biomed who are on the leading edge of psilocybin-based drug development. We look forward to a mutually successful partnership.”
“As we continue to efficiently advance our Phase IIb clinical trial for Adjustment Disorder in Palliative Care, these binding agreements with Optimi ensure that we have a consistent supply of very high quality, nature derived psilocybin for pivotal registrational Phase III studies, commercial production if approved, and potential expansion into new indications,” said Dr. Neil Maresky, M.B.,B.Ch., Chief Executive Officer of Psyence Biomed. “We are pleased to have found a partner in Optimi that shares our commitment to the development of psilocybin-based therapeutics as potential treatments for a broad range of underserved mental health conditions.”
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines 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, regulatory-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Email: ir@psyencebiomed.com
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General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com