Optimi Health Completes Latest Production Batch Of Its MDMA Finished Drug Product; Proposed Phase 3 Trial Expected To Begin In 2027

The capsules were manufactured at Optimi’s GMP facility in Princeton, British Columbia, under its Health Canada Drug Establishment Licence, and are expected to supply three programs: the recently announced proposed Phase 3 clinical trial of MDMA-assisted therapy in Canada (the "Proposed Phase 3 Trial") for the treatment of post-traumatic stress disorder ("PTSD"), its next commercial export to Australia planned before the end of 2026, and a previously announced clinical trial in Israel in partnership with the Multidisciplinary Association for Psychedelic Studies ("MAPS").

The Proposed Phase 3 Trial is intended to enroll up to 100 participants across multiple sites in Canada, focusing on veterans and current or former frontline workers. Participants are expected to receive the Company's synthetic MDMA hydrochloride, supplied in two dosage formats, during two supervised sessions combining MDMA and psychotherapy spaced several weeks apart, with follow-up evaluations after the final session. The primary efficacy endpoint will be change in the Clinician-Administered PTSD Scale (CAPS-5), which is the standard clinician-rated instrument for assessing PTSD severity. The Proposed Phase 3 Trial is expected to begin in 2027.

Optimi has received Australian import permits for MDMA, with the next shipment planned before the end of 2026 to supply clinics and pharmacies across the country through Optimi Australia. In Australia, clinicians are authorized to prescribe MDMA capsules to patients with PTSD under the Therapeutic Goods Administration's Authorised Prescriber Scheme, with reimbursement from public and private payers including the Department of Veterans' Affairs, the National Disability Insurance Scheme, WorkCover, and Medibank. More than 750 clinicians have completed Mind Medicine Australia’s Certificate in Psychedelic-Assisted Therapies, and Optimi is not aware of any reported serious adverse events among patients since commercial supply began in 2024.