Shares of Psyence Biomedical Ltd. (NASDAQ: PBM) experienced a significant uptick in pre-hour trading, climbing 27.05% to $2.63. This surge follows the announcement of a binding agreement with Optimi Health Corp., marking a pivotal step in Psyence’s global drug development strategy for palliative care applications.
Key Agreement Details
The newly executed agreement transitions from the previously announced non-binding Letter of Intent (LOI) to a binding commitment. Optimi Health Corp. is now the exclusive supplier of Good Manufacturing Practice (GMP)-certified, nature-derived psilocybin extract for Psyence’s clinical and commercial initiatives.
This partnership positions Optimi as a critical supplier for PBM’s FDA-approved therapeutic programs, particularly in the context of palliative care. Additionally, Optimi will provide robust Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions. Psyence secures exclusive rights to Optimi’s drug candidate, fortifying its drug development pipeline for potential global applications.
Strategic Clinical Advancements
This collaboration strategically supports Psyence Biomedical’s clinical efforts, including its ongoing Phase IIb trial for Adjustment Disorder in palliative care. The agreement ensures a steady supply of high-quality, natural psilocybin for anticipated Phase III registrational studies. Optimi’s involvement also sets the stage for commercial-scale production, pending regulatory approvals, and the exploration of new therapeutic indications.
The agreement underscores Psyence’s commitment to advancing psilocybin-based treatments, an area gaining global recognition. Optimi Health’s comprehensive support reinforces its role as a preferred partner for innovative companies in the psychedelic drug development space.
Equity Realignment with Psyence Group
In a complementary move, Psyence Group Inc. announced an addendum to its debt-for-equity swap agreements with PBM. Under the revised terms, Psyence Biomedical will issue 337,750 common shares at $3.88 per share to Psyence Group. This transaction resolves outstanding financial obligations tied to previous agreements and PBM’s NASDAQ listing earlier in 2024.
This suite of strategic initiatives strengthens Psyence Biomed’s operational and financial positioning as it progresses toward pivotal clinical milestones and potential commercialization.