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Optimi Health Corp (2)
Symbol OPTI
Shares Issued 5,725,867
Close 2026-09-23 C$ 7.01
Market Cap C$ 40,138,328
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Optimi completes psilocybin batch for phase 2 trial

2026-09-23 17:57 ET - News Release

Mr. Dane Stevens reports

OPTIMI HEALTH COMPLETES PSILOCYBIN PRODUCTION FOR HEALTH CANADA-APPROVED PHASE 2 MDD TRIAL AND COMMERCIAL TRD SUPPLY

Optimi Health Corp. has completed, including the quality release, of a production batch of five-milligram naturally derived psilocybin capsules, manufactured end to end at the company's cGMP (current good manufacturing practice) facility in Princeton, B.C., 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 five mg 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.

"Since 2025, Optimi has supplied this psilocybin product commercially to licensed clinics in Australia, where it is prescribed and reimbursed for treatment-resistant depression," said Dane Stevens, Optimi chief executive officer and co-founder. "We are excited to be collecting our own clinical data on the same product in our Health Canada-approved phase 2 clinical trial for major depressive disorder. One drug, two indications with significant unmet need, one batch serving both. Because we manufacture, encapsulate and release-test within our own licensed facility, the trial product and the commercial product are the same formulation from the same batch, and the chemistry, manufacturing and controls file that supports registration is already ours."

The safety and efficacy of psilocybin assisted therapy to treat MDD is still under investigation and none of Optimi's psilocybin drug products received market authorization by Health Canada.

About Optimi Health Corp.

Optimi Health 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.

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