Optimi Health launches psilocybin capsules in Australia

Mr. Dane Stevens reports OPTIMI HEALTH ANNOUNCES LAUNCH OF PSILOCYBIN CAPSULES IN AUSTRALIA FOR TREATMENT-RESISTANT DEPRESSION Optimi Health Corp. has commercially launched 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 five milligrams 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 licence, 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 co-ordination 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 posttraumatic 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 five mg natural psilocybin finished drug product alongside our 40 mg and 60 mg 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 About Optimi Health Corp. Optimi Health is a leading producer of prescribed psychedelic treatments for mental health therapies. As a Health Canada-licensed, GMP-compliant pharmaceutical manufacturer producing validated MDMA and botanical psilocybin products from two 10,000-square-foot facilities in British Columbia, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. We seek Safe Harbor.