Psyence Biomedical says ‘foundation in place’ to be R&D leader in psilocybin

Psyence Biomedical issued a letter to shareholders, which read in part, “Having recently commenced trading on the Nasdaq stock exchange under the ticker “PBM,” following the completion of our business combination with Newcourt Acquisition Corp., I am happy to write to update you on our recent progress and upcoming milestones. Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company. These include expanded access to capital to fund our development programs and the opportunity to share the Psyence story more broadly and garner support from more sophisticated long-term institutional life sciences investors to further enhance our value. Recall that we are exploring the therapeutic potential of nature-derived psilocybin, beginning with a focus on adjustment disorder in Palliative Care. While other companies are exploring synthetic psilocybin, Psyence is the world’s first Nasdaq traded biopharmaceutical company researching a nature-derived psilocybin candidate. Furthermore, Psyence is the only publicly traded company to research a non-synthetic psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care. Our proprietary market research suggests that the U.S. Palliative Care market will grow at a compound annual growth rate of 9.4% through 2030, reaching $28.6 billion in annual market opportunity…To that end, we are in the process of initiating a Phase IIb clinical trial of 25mg nature-derived Psilocybin in Australia and have recently received approval of our trial protocol by Australia’s Human Research Ethics Committee. It is worth noting that we obtained approval for a similar, though not identical, trial protocol in the U.K., but shifted our focus to Australia to capture the economic benefits, including significant R&D tax credits, of executing trials in that country. Running the trial in Australia also gives us the opportunity to partner with iNGEN, a leading Contract Research Organization with specific expertise in executing psychedelic clinical trials. The trial will be a double-blind, randomized, controlled trial of three doses of psilocybin – 1mg, 10mg and 25mg with psychotherapy. We plan to randomize the first patient in the second quarter of 2024, and we anticipate topline results in 2025. If successful, we would move to initiate a registrational Phase III trial as expeditiously as possible. Longer-term, we have identified opportunities to evaluate nature-derived psilocybin in a broad range of indications with unmet medical needs, and in parallel with our lead clinical program, we also hope to advance a pipeline of additional large-market indications. Our in-licensed technology is protected by an extensive intellectual property portfolio spanning five distinct patent families, including process patents covering the extraction, purification, and standardization of nature-derived psilocybin. In addition, we have an opportunity to secure additional regulatory protections that provide for market exclusivity for new chemical entities upon approval. Finally, we are well financed, with up to $10.0 million of cash and equivalents following the offering of senior secured convertible notes. We believe our current resources are sufficient to complete the Phase IIb study in for Adjustment Disorder in the context of Palliative Care, while pursuing a follow-on indication. In closing, the completion of our merger with Newcourt and concurrent listing on the Nasdaq stock exchange is a significant achievement for our company. We believe we have the foundation in place to be a leader in the research and development of nature-derived psilocybin-based therapeutics to treat a range of medical conditions where safer and more effective treatment options are desired.”