Batch sufficient to supply the proposed Canadian Phase 3 trial, a clinical trial in Israel in partnership with MAPS and a commercial export to treat PTSD in Australia
Batch sufficient to supply the proposed Canadian Phase 3 trial, a clinical trial in Israel in partnership with MAPS and a commercial export to treat PTSD in Australia
Health Canada-authorized trial to evaluate efficacy and safety of two sessions of MDMA-assisted therapy in up to 100 veterans and frontline workers
VANCOUVER, British Columbia, Oct. 20, 2026 — Optimi Health Corp. (Nasdaq: OPTH, CSE: OPTI, FSE: 8BN) (“Optimi” or the “Company”), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today announced the completion of its latest production batch of its MDMA (3,4-methylenedioxymethamphetamine) finished drug product. 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.
“Veterans in Australia can already access MDMA-assisted therapy through their own government. Veterans in Canada cannot,” said Dane Stevens, Optimi Chief Executive Officer and Co-Founder. “The Canadian Phase 3 trial is how we hope to close that gap, and the medicine for that trial is already made. We are proud to supply MDMA commercially to clinics in Australia, and we are keeping a keen eye on the United States and other jurisdictions as access expands.”
The safety and efficacy of MDMA-assisted therapy to treat PTSD is still under investigation in Canada, and none of Optimi’s MDMA drug products have received market authorization by Health Canada.
As previously announced on November 26, 2025, Optimi supplies the MDMA capsules for MAPS Israel’s Healing October 7th project, which includes a clinical trial for PTSD that has received formal approval from the Israeli Ministry of Health. Further details on this clinical trial can be found in Optimi’s November 26, 2025 press release.
About Optimi Health Corp.
Optimi Health Corp. is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. Optimi supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country’s Authorised Prescriber Scheme and accessible in Canada through the Special Access Program.
For more information, please visit optimi.net.
