The shipment included 1,000 capsules of 5mg psilocybin, which are being prescribed in Australia for treatment-resistant depression ("TRD"), an indication for which regulated patient access is available. TRD refers to major depression that has not responded to multiple standard antidepressant treatments and represents a significant unmet medical need.
"We are proud to be among the few Nasdaq-listed companies commercially supplying psilocybin to patients with treatment-resistant depression outside of clinical trials," said Dane Stevens, CEO and Co-Founder of Optimi. "Our medicine is produced start to finish in Canada and shipped to pharmacy partners globally, and we are seeing expanding reimbursement coverage from both private and public insurers. We believe Australia is providing an early model for how naturally derived psilocybin can be safely prescribed for TRD in real-world practice, and we are not aware of any serious adverse events reported since inception based on data collected through December 31, 2025."
Australia became the first country in the world to recognize psilocybin as a medicine, rescheduling it from a prohibited substance to a controlled medicine for the treatment of TRD, effective July 1, 2023. MDMA was rescheduled for the treatment of post-traumatic stress disorder on the same day, and Optimi manufactures both psilocybin and MDMA. Patients have since gained broader access under an updated Authorized Prescriber framework that expanded therapist eligibility and treatment settings, as detailed in the Company’s news release dated May 29, 2026.
Under the Therapeutic Goods Administration’s Authorized Prescriber Scheme, Optimi’s psilocybin is being prescribed to patients in Australia and reimbursed by both public and private payers, including the Department of Veterans’ Affairs, the National Disability Insurance Scheme, WorkCover, and Medibank. More than 750 clinicians have been trained to deliver the therapy, and the Company is not aware of any serious adverse events that have been reported under the scheme after more than two years of regulated commercial use.
The exported capsules were produced start to finish in-house at Optimi’s wholly owned GMP facility in Princeton, British Columbia, Canada, under its Health Canada Drug Establishment Licence, and shipped under export authorization issued by Health Canada. Optimi is among a small number of GMP-licensed manufacturers supplying naturally derived psilocybin to the Australian market, where recurring orders contribute to commercial revenue for the Company.
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