Optimi Health Completes Psilocybin Export to Australia for Patients With Treatment-Resistant Depression

Executive Summary

• Optimi Health Corp. completed its third commercial export of 5mg psilocybin capsules to Australia, marking continued commercial supply of the drug for treatment-resistant depression (TRD).
• The specific shipment consisted of 1,000 capsules produced in-house at the company’s GMP facility in Princeton, British Columbia.
• The product is prescribed under Australia’s Authorized Prescriber Scheme, with reimbursement available from major public and private payers, including the Department of Veterans’ Affairs and Medibank.

Key Details

• Shipment Volume: 1,000 capsules of 5mg psilocybin.
• Commercial Milestone: This is the third commercial shipment since the launch of the 5mg psilocybin capsules in September 2025.
• Product Origin: Produced start-to-finish in-house at Optimi’s wholly owned Good Manufacturing Practice (GMP) facility in Princeton, British Columbia, under Health Canada’s Drug Establishment Licence.
• Regulatory Status in Australia: Psilocybin is rescheduled as a controlled medicine for TRD (effective July 1, 2023) under the Therapeutic Goods Administration’s Authorized Prescriber Scheme.
• Reimbursement Payers: Public and private payers include the Department of Veterans’ Affairs, the National Disability Insurance Scheme, WorkCover, and Medibank.
• Clinical Safety Data: The company reports no known serious adverse events since inception based on data collected through December 31, 2025, following over two years of regulated commercial use.
• Market Context: Australia is the first country to recognize psilocybin as a medicine for TRD; Optimi is among a small number of GMP-licensed manufacturers supplying naturally derived psilocybin to this market.
• Additional Products: Optimi also manufactures MDMA, which was rescheduled for PTSD treatment in Australia on the same date as psilocybin.

Notable Quotes

• "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."