Announcement • Apr 17
Psyence Biomedical Ltd Advances Nature-Derived Psilocybin And Ibogaine Therapies Psyence Biomedical Ltd. acknowledged recent reports that the U.S. administration is preparing an executive order to further evaluate the safety and therapeutic potential of ibogaine, a naturally occurring compound being studied for its potential in treating post-traumatic stress disorder (PTSD), addiction, and other serious neurological and mental health conditions. The anticipated executive action reflects growing recognition of the need for rigorous, regulated research into novel therapies, particularly in areas where current treatment options remain limited. Ibogaine remains a Schedule I substance in the United States, and patients often seek access through unregulated settings outside the country. Psyence BioMed believes that advancing controlled clinical research and regulated development pathways is essential to improving both patient safety and long-term access. Through its strategic investment in PsyLabs, Psyence BioMed has established a leading position in the GMP-compliant manufacturing of ibogaine and ibogaine derivatives, with operations aligned to support global clinical research and future therapeutic development. The Company has also previously announced the development of a responsible and ethically sourced ibogaine supply chain, working within the compound’s native African ecosystem to ensure sustainability, traceability, and respect for traditional and environmental considerations. As global interest in ibogaine accelerates, Psyence BioMed’s integrated platform – combining ethical sourcing, GMP manufacturing, and clinical development capabilities – positions the Company to play a meaningful role in supporting the next phase of research and potential regulatory evolution. The availability of standardized, responsibly sourced ibogaine will be critical to enabling credible scientific progress. Announcement • Mar 03
Psyence Biomedical Ltd. Announces Export Of GMP-Manufactured Natural Psilocybin NPX-5 To Australia For Ongoing Phase IIb Clinical Trial Psyence Biomedical Ltd. had announced the successful export of fully GMP-compliant manufactured psilocybin product NPX-5 (1mg and 5mg capsules) to Australia. The product was manufactured at the Psyence Labs Ltd. GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development. The shipment represents an operational achievement for both Psyence BioMed and PsyLabs, reinforcing their shared commitment to establishing a regulated global supply chain for nature-derived psychedelic therapeutics. The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia – a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context. The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth. Psyence BioMed is currently the only company conducting a Phase IIb clinical trial using natural psilocybin to study Adjustment Disorder in a palliative oncology population. Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5. The Phase IIb trial focuses on Adjustment Disorder, an excessive and sometimes debilitating psychological response to a significant life stressor – in this case, advanced cancer. The study aims to evaluate the efficacy, safety, and durability of a psycho-therapeutic approach utilizing nature-derived psilocybin to reduce anxiety and depressive symptoms in this vulnerable patient population. As a regulated, nature-derived formulation rather than a synthetic analogue, Psyence BioMed’s approach represents a differentiated pathway within psychedelic therapeutics – integrating pharmaceutical-grade manufacturing with clinical rigor in palliative mental health care. PsyLabs operates a GMP-compliant production and analytical facility capable of manufacturing pharmaceutical-grade natural psilocybin and ethically sourced ibogaine at scale. The successful export of NPX-5 capsules to Australia demonstrates: Full GMP compliance. International regulatory authorization for shipment. Operational global supply chain capability. Vertical integration across cultivation, extraction, manufacturing, and quality assurance. Announcement • Feb 11
Psyence Biomedical Ltd. Enters into Settlement Agreement to Resolve Direct Shareholder Claim Made by KAOS Capital Ltd Psyence Biomedical Ltd. has entered into a settlement agreement to resolve a direct shareholder claim made by KAOS Capital Ltd. The claim, originally made on January 14, 2026, and amplified on January 26, 2026, alleged improper and oppressive actions on the part of the Company against KAOS, resulting in KAOS suffering alleged damages. The Company, its board of directors and officers have denied the allegations and believe they are unsubstantiated and meritless. On January 16, 2026, KAOS issued a notice of application in the Ontario Superior Court with respect to the KAOS Allegations and sought, among other remedies, to adjourn the shareholders' meeting of the Company originally scheduled for January 22, 2026. On January 21, 2026, the Court dismissed the Application and ordered KAOS to pay the Company's costs fixed in the amount of CDN 75,000. Under the terms of the settlement, the Company will pay an aggregate amount of USD 1,500,000 to KAOS and the Company has agreed to release KAOS from any obligation to pay the Costs Award. KAOS agrees that it will sell, or cause to be sold, all the common shares held by it in the Company to a third party designated by the Company at a price of USD 5 per share. The settlement also includes a full retraction of the unproven KAOS Allegations, a full mutual release of all claims between the parties and such other customary undertakings of a settlement of this nature. The settlement represents a compromise of disputed claims and does not constitute an admission of liability or wrongdoing by the Company, the Board or any of its officers. The Company expects that the settlement will be funded by cash on hand and will be recorded in accordance with applicable accounting standards. Although the Company, the Board and its officers deny any wrongdoing, they have opted for a settlement to avoid further litigation, disruption to the Company's business, and the significant costs related thereto.