Psyence Biomedical Ltd. Issues Shareholder Letter Recapping Recent Progress and Outlining Key Future Milestones - Seite 2

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 (HREC). 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 iNGENū, a leading Contract Research Organization (CRO) 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 (NCEs) upon approval.

Finally, we are well financed, with up to US$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.