Optimi Health Announces Launch of Psilocybin Capsules in Australia for Treatment-Resistant Depression

Vancouver, British Columbia--(Newsfile Corp. - September 3, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP psychedelic medicines, is pleased to announce the commercial launch of its natural psilocybin capsules in Australia, which are now being prescribed to patients with Treatment-Resistant Depression ("TRD") under the Authorised Prescriber Scheme.

The initial shipment of 1,000 psilocybin capsules, each containing 5mg of standardized naturally-derived psilocybin, was manufactured entirely in-house at Optimi's GMP-licensed facility in British Columbia, Canada. Optimi's vertically integrated process spans cultivation, extraction, formulation, and encapsulation under its Health Canada-issued Drug Establishment License, enabling the finished drug product to be prescribed for the indication of TRD in Australian patients. Following independent Certificate of Analysis ("COA") testing confirming compliance with Australia's Therapeutic Goods Administration ("TGA") specifications, the export was completed with clearance from Health Canada, the TGA, and Australia's BICON Biosecurity Authority.

Mind Medicine Australia, Optimi's authorized commercial partner, will oversee distribution and patient coordination through Australia's network of clinics and hospitals. Patient-reported outcome data where possible will be collected throughout treatment, supporting one of the most comprehensive real-world evidence sets for psilocybin to date.

This launch follows Optimi's successful introduction of MDMA sales in Australia for Post-Traumatic Stress Disorder ("PTSD") in October 2024, marking two psychedelic finished drug products now commercially available under a government-sanctioned prescription framework.

Dane Stevens, Chief Executive Officer of Optimi, said: "Launching our 5mg natural psilocybin finished drug product alongside our 40mg and 60mg MDMA capsules is an exciting milestone for Optimi. For the first time, both of our GMP psychedelic medicines are available through a regulated government program — a major step forward in our mission to deliver scalable psychedelic treatments directly to clinics."

Peter Hunt AM, Chair of Mind Medicine Australia, added: "This is a significant step for Australian patients suffering from TRD. Much of this initial shipment will be allocated across our network of clinics, underscoring the growing demand in the market today. We look forward to continuing our collaboration with Optimi to ensure broad, cost-effective access to patients throughout the country."

How to Access Optimi's Capsules

To learn more about accessing Optimi's psilocybin or MDMA capsules, please contact sales@optimihealth.ca.

For patients in Australia, please contact Optimi's authorized partner Mind Medicine Australia at medicines@mindmedicineaustralia.org.