Psyence Biomedical Ltd (Nasdaq: PBM) is poised to hit several psilocybin-related “milestones” in coming months, including the acquisition of drug developer Clairvoyant, the launch of research into psilocybin as a treatment for substance use disorders and ongoing clinical trials in Australia for psilocybin in treating adjustment disorder.
CEO Dr. Neil Maresky shared details on the company’s ongoing moves in a shareholder update issued this week.
Psyence signed a conditional binding term sheet earlier this month to acquire Clairvoyant in an all-stock deal reportedly worth $500,000. Clairvoyant has its own clinical trials underway to evaluate psilocybin as a treatment for alcohol use disorder, with topline data expected in the second half of next year.
Maresky wrote that the acquisition “makes strategic sense for Psyence” because it runs parallel to Psyence’s own aims of mainstreaming psilocybin.
The acquisition also “expands our pipeline into AUD – a high-value indication – with a regulatory pathway that, if successful, will transition us to a commercial-stage, revenue-generating company,” he wrote.
The deal also connects directly to a business opportunity Psyence was eyeballing: substance use disorder treatment. The company has also been organizing new research into how psilocybin can be used to help patients with alcohol use disorder or other drug problems, and has signed a deal with Psylabs for “highly purified psilocybin extract” to be used in research.
“Numerous prior academic studies suggest that psilocybin, when combined with psychotherapy, can be a safe and effective treatment option for these individuals (with substance use disorder) – something that we aim to confirm in rigorously designed clinical studies,” Maresky wrote, noting there were 44 million people in the U.S. alone diagnosed with the ailment in 2021.
Psyence is also busy recruiting patients for an upcoming Phase 2b clinical trial in Australia for adjustment disorder treatments with psilocybin, from which it hopes to get topline data late next year that will support Phase 3 clinical trials. Those trials are being done in partnership with Fluence and iNGENū CRO Pty Ltd, and are evaluating two doses of naturally grown psilocybin, one at a 10 milligram dose and another with 25 milligrams.
To that end, Psyence also signed a supply contract with Canada-based Optimi, which ships naturally grown psilocybin and extracts all over the globe for medical research and treatments.
Psyence, which is still pre-revenue and working to bring psychedelic treatments to market, went through a merger in the spring to get uplisted to the Nasdaq from the Canadian Securities Exchange, and it appears the move has paid off.
Maresky wrote that in order to further the goals outlined in the update, Psyence has a “strengthened financial position” achieved by lining up “agreements that are expected to provide us with sufficient capital,” which may not have been possible without the Nasdaq.
However, the company has struggled to maintain the Nasdaq’s required Market Value of Listed Securities and Market Value of Publicly Held Shares. Last week, the exchange notified the Psyence Biomedical that it is at risk of being delisted. Psyence intends to request a hearing on the matter.
[[{“value”:”The advancements have focused on developing treatments for substance use disorders, including alcohol.
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