NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context.

The Company previously announced that it had entered into partnerships 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 the study. Following a recent site visit by Psyence Biomed leadership to partners and trial sites in Australia, the Company is preparing to initiate the study shortly following the recent successful export of drug candidate, PEX010, from its current supplier, Filament Health.

“Over the past several months, we have made substantial progress preparing for our Phase IIb study, and following my recent site visit to Australia, I am pleased to report that all parties, including Psyence and our partners, Fluence and iNGENū, are poised to initiate the study imminently,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “With the successful export of PEX010, we now plan to focus on the efficient enrollment of patients into this important study.”

The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 84 patients in conjunction with psychotherapy. Psyence aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies.

More information on the study can be found at: 12624000449538p.

Filament Health Commercial Licensing Agreement Update

Psyence Biomed’s commercial licensing agreement with Filament Health, which covered supply of PEX010 for pivotal Phase III studies in Adjustment Disorder and also granted Psyence Biomed the worldwide right to commercialize PEX010 (25 mg) within the context of Palliative Care, remained subject to further negotiations between the parties and the completion of a subsequent definitive agreement within a predefined time period.

Following further discussions, both parties have mutually agreed to terminate the commercial licensing agreement. Filament Health will continue to support the supply PEX010 for the upcoming Phase IIb trial, as previously announced. Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America. The Company intends to provide further updates on such agreements as they are executed. However, there can be no guarantees that such agreements will be finalized.

“We have made significant progress identifying alternative suppliers of nature-derived, non-synthetic psilocybin for use in subsequent clinical studies, and we look forward to securing a partner that can support our needs over the long-term,” stated Dr. Neil Maresky, CEO of Psyence Biomed. “Importantly, this change should have minimal impact on our internal development timelines for our Phase IIb program, and we remain committed to introducing a novel therapy for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context as efficiently as possible.”