Optimi Health Announces Launch of Psilocybin Capsules in Australia for Treatment-Resistant Depression

Rhea-AI Summary

Optimi Health (OTCQX: OPTHF) has launched natural psilocybin capsules in Australia for treating Treatment-Resistant Depression (TRD) under the Authorised Prescriber Scheme. The company has shipped 1,000 capsules containing 5mg of standardized naturally-derived psilocybin, manufactured at their GMP-licensed facility in British Columbia.

The launch follows Optimi's successful introduction of MDMA sales for PTSD treatment in Australia in October 2024. Mind Medicine Australia, Optimi's commercial partner, will manage distribution and patient coordination through Australian clinics and hospitals, while collecting patient-reported outcome data to build comprehensive real-world evidence for psilocybin treatment.

Positive

• First commercial launch of natural psilocybin capsules in Australia for TRD treatment
• Successful vertical integration from cultivation to encapsulation under Health Canada Drug Establishment License
• Second psychedelic product commercially available through government-sanctioned framework
• Partnership with Mind Medicine Australia enables broad distribution network

Negative

• None.

Export of 1,000 natural psilocybin capsules for prescription use under Australia's Authorised Prescriber Scheme follows the Company's successful launch of MDMA sales in 2024

Vancouver, British Columbia--(Newsfile Corp. - September 3, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP psychedelic medicines, is pleased to announce the commercial launch of its natural psilocybin capsules in Australia, which are now being prescribed to patients with Treatment-Resistant Depression ("TRD") under the Authorised Prescriber Scheme.

The initial shipment of 1,000 psilocybin capsules, each containing 5mg of standardized naturally-derived psilocybin, was manufactured entirely in-house at Optimi's GMP-licensed facility in British Columbia, Canada. Optimi's vertically integrated process spans cultivation, extraction, formulation, and encapsulation under its Health Canada-issued Drug Establishment License, enabling the finished drug product to be prescribed for the indication of TRD in Australian patients. Following independent Certificate of Analysis ("COA") testing confirming compliance with Australia's Therapeutic Goods Administration ("TGA") specifications, the export was completed with clearance from Health Canada, the TGA, and Australia's BICON Biosecurity Authority.

Mind Medicine Australia, Optimi's authorized commercial partner, will oversee distribution and patient coordination through Australia's network of clinics and hospitals. Patient-reported outcome data where possible will be collected throughout treatment, supporting one of the most comprehensive real-world evidence sets for psilocybin to date.

This launch follows Optimi's successful introduction of MDMA sales in Australia for Post-Traumatic Stress Disorder ("PTSD") in October 2024, marking two psychedelic finished drug products now commercially available under a government-sanctioned prescription framework.

Dane Stevens, Chief Executive Officer of Optimi, said: "Launching our 5mg natural psilocybin finished drug product alongside our 40mg and 60mg MDMA capsules is an exciting milestone for Optimi. For the first time, both of our GMP psychedelic medicines are available through a regulated government program — a major step forward in our mission to deliver scalable psychedelic treatments directly to clinics."

Peter Hunt AM, Chair of Mind Medicine Australia, added: "This is a significant step for Australian patients suffering from TRD. Much of this initial shipment will be allocated across our network of clinics, underscoring the growing demand in the market today. We look forward to continuing our collaboration with Optimi to ensure broad, cost-effective access to patients throughout the country."

How to Access Optimi's Capsules

To learn more about accessing Optimi's psilocybin or MDMA capsules, please contact sales@optimihealth.ca.

For patients in Australia, please contact Optimi's authorized partner Mind Medicine Australia at medicines@mindmedicineaustralia.org.

About Optimi Health Corp.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) is a leading producer of prescribed psychedelic treatments for mental health therapies. As a Health Canada-licensed, GMP compliant pharmaceutical manufacturer producing validated MDMA and botanical psilocybin products from two 10,000-square-foot facilities in British Columbia, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. For more information, please visit www.optimihealth.ca.

Forward-Looking Statements

This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"). Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.

Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's long form prospectus dated February 12, 2021, a copy of which is available on SEDAR+ at www.sedarplus.ca. Except as expressly required by applicable law, Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.

For more information, please contact:
Dane Stevens, CEO
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca

Investor Relations Contact
Lucas A. Zimmerman
Managing Director
MZ Group - MZ North America
(262) 357-2918
OPTHF@mzgroup.us
www.mzgroup.us

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/264871

FAQ

What is the dosage of Optimi Health's psilocybin capsules for Treatment-Resistant Depression?

Optimi Health's psilocybin capsules contain 5mg of standardized naturally-derived psilocybin per capsule.

How many psilocybin capsules did Optimi Health (OPTHF) ship to Australia?

Optimi Health shipped an initial quantity of 1,000 psilocybin capsules to Australia.

Who is distributing Optimi Health's psilocybin capsules in Australia?

Mind Medicine Australia is Optimi's authorized commercial partner responsible for distribution and patient coordination through Australian clinics and hospitals.

What regulatory approvals did Optimi Health receive for Australian psilocybin distribution?

The export received clearance from Health Canada, Australia's Therapeutic Goods Administration (TGA), and Australia's BICON Biosecurity Authority.

How can patients access Optimi Health's psilocybin capsules in Australia?

Australian patients can access the capsules through Mind Medicine Australia by contacting medicines@mindmedicineaustralia.org.