Optimi Health Completes First Export of Psilocybin to the United Kingdom for Phase 2 Clinical Trial

Executive Summary

• Optimi Health Corp. completed its first export of naturally derived psilocybin (biomass and 5mg capsules) to the United Kingdom to support a planned Phase 2 clinical trial.
• The exported product is manufactured in-house at the company's GMP facility in Princeton, BC, utilizing proprietary extraction methods under a Health Canada Drug Establishment Licence.
• The shipment highlights Optimi's vertically integrated supply chain, capable of serving both commercial patient markets (currently in Australia) and clinical research from a single licensed facility.

Key Details

• First export of naturally derived psilocybin to the United Kingdom.
• Shipment comprises psilocybin biomass and finished 5mg psilocybin capsules.
• Product intended to support a planned Phase 2 clinical trial in the UK (trial partner and specific indication to be announced at a later date).
• Capsules utilize the exact same formulation currently prescribed to patients in Australia for treatment-resistant depression (TRD).
• Manufactured in-house at Optimi's GMP facility in Princeton, British Columbia, Canada.
• Shipped under export authorization issued by Health Canada and import authorization from the UK Home Office.
• Follows a recently completed GMP production run of 5mg psilocybin drug product, with a portion specifically earmarked for European clinical research.
• Company cultivated biomass and produced finished capsules in-house, extracting the active pharmaceutical ingredient (API) using proprietary methods under its Health Canada Drug Establishment Licence (DEL).
• Positions Optimi as a vertically integrated GMP supplier for regulated psychedelic research and medicine, capable of supplying both biomass and finished drug product from a single licensed facility.
• Company supplies finished psilocybin and MDMA drug products to regulated markets internationally for both patient access and clinical research.

Notable Quotes

• "This is our first shipment into the United Kingdom, and it is the same psilocybin we already supply to patients in Australia," said Dane Stevens, CEO and Co-Founder of Optimi. "We can serve a commercial market and a clinical trial from the same GMP facility, on our own licence. That is a rare position, and one we have spent years building."