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 and quality release of a production batch of 5mg naturally derived psilocybin capsules, manufactured end to end at the Company’s cGMP facility in Princeton, British Columbia, under a Health Canada Drug Establishment Licence. The batch will supply the recently announced Phase 2 clinical trial of psilocybin-assisted therapy evaluating psilocybin-assisted therapy in the treatment of major depressive disorder ("MDD") and commercial customers in Australia.

This Health Canada-authorized trial is a multisite, open-label study of up to 200 participants, each receiving a single supervised dose of Optimi’s . Patient dosing is expected to be completed by the end of 2027. Data from the trial are intended to assess the safety and efficacy of psychedelic-assisted therapy in the hope of building the necessary evidentiary base to support registration in Canada and other jurisdictions.

The same batch will also supply the Company’s Australian customer base of licensed clinics, where 5mg psilocybin capsules are prescribed to patients with treatment-resistant depression 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 since commercial supply began in 2025.