Psyence Biomed Signs Conditional Term Sheet to Acquire Clairvoyant

Psyence Biomedical Ltd. (Nasdaq: PBM) has announced a conditional binding term sheet with Clairvoyant Therapeutics Inc, a clinical-stage developer of psilocybin-based therapeutics. The proposed acquisition would see Psyence Biomed acquiring 100% of Clairvoyant's shares. As part of the deal, Psyence Biomed will issue $500,000 worth of its common shares to Clairvoyant’s shareholders at the time of closing. There are also provisions for two additional potential share-based payments of $250,000 each, contingent on meeting certain milestones by December 2026. Additionally, Psyence Biomed will provide up to $1,800,000 to Clairvoyant to cover its liabilities, mainly related to clinical trial expenses.

Clairvoyant is conducting a Phase IIb clinical trial (CLA-PSY-201) to evaluate a synthetic psilocybin candidate for treating Alcohol Use Disorder (AUD). They have successfully enrolled and treated 154 randomized double-blind subjects in this study, with topline results expected in early 2025.

Dr. Neil Maresky, CEO of Psyence Biomed, stated that the acquisition is strategically beneficial as it introduces a synthetic psilocybin-based therapeutic candidate that complements their current nature-derived psilocybin program. This program is focused on treating Adjustment Disorder in palliative care settings. The acquisition could also expand Psyence Biomed’s pipeline into AUD, potentially leading the company to a commercial-stage, revenue-generating status.

Dr. Maresky emphasized that with this acquisition, Psyence Biomed would have access to two critical Phase II data read-outs. If successful, these results could position the company as a leader in developing psychedelic-based therapeutics for various mental health disorders that currently lack effective treatment options.

Damian Kettlewell, CEO of Clairvoyant, expressed enthusiasm for the partnership, highlighting the significant unmet need for AUD treatments. He noted that 15% of adult drinkers in the EU, Canada, and the UK are at risk for AUD, yet fewer than 1% seek drug therapy. Current treatments have limited efficacy and poor compliance.

Kettlewell cited prior research, including a study by NYU Langone published in JAMA Psychiatry in 2022, which showed an 83% average reduction in alcohol consumption with psilocybin-assisted psychotherapy. Another study from August 2024 indicated that a single dose of psilocybin was safe and effective in reducing alcohol consumption in AUD patients. These findings provide strong scientific support for ongoing development in this area.

The ongoing Phase IIb clinical trial by Clairvoyant is a 24-week, multi-center, randomized, double-blind, placebo-controlled study. It involves two administrations of 25mg psilocybin at weeks five and nine, combined with psychotherapy, compared to a placebo. Twelve study sites across the EU and Canada are participating, with 154 subjects diagnosed with moderate to severe AUD based on DSM-5 criteria. All participants have expressed a desire to reduce or stop their alcohol consumption.

The proposed acquisition is subject to the finalization of a definitive share purchase agreement and several conditions, including board and regulatory approvals, satisfactory due diligence, and other customary conditions.

Psyence Biomedical Ltd. is a pioneering life science biotechnology company focused on developing botanical psilocybin-based psychedelic medicine. The company's name combines "psychedelics" and "science," reflecting its commitment to evidence-based innovation. Psyence Biomed aims to create safe and effective nature-derived psychedelic therapeutics to address a wide range of mental health disorders, initially focusing on those within palliative care contexts.

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