Vancouver, British Columbia--(Newsfile Corp. - January 6, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in natural psilocybin and MDMA, is pleased to announce the completion of its second shipment of GMP-certified MDMA capsules to Australia.
Optimi has also increased its 2025 production forecast to supply enough MDMA capsules for over 5,000 patients globally. This expanded capacity highlights the Company's commitment to ensuring healthcare providers in Australia have consistent access to high-quality GMP-certified products while also supporting ongoing and future clinical trials.
Key Highlights
Second Export Complete: The second shipment of GMP-certified MDMA capsules has arrived in Australia and will support PTSD treatments throughout 2025.
Increasing Demand: Optimi's production forecast has been increased to supply enough MDMA capsules for over 5,000 patients globally.
On-Site Manufacturing: Optimi's MDMA capsules are produced at its purpose-built facilities under the Company's Drug Establishment Licence and are distributed through a regulated pharmacy network in partnership with Mind Medicine Australia.
Data Collection Advancements: Patient-reported outcomes (PROs) are being gathered via the Australian National University's registry, creating one of the largest Real World Evidence (RWE) datasets on MDMA-assisted therapy to date.
Dane Stevens, CEO of Optimi Health
"With the completion of our second shipment of GMP-certified MDMA capsules to Australia, we're making meaningful progress in delivering high-quality therapeutic options to patients today," said Dane Stevens, CEO of Optimi Health. "This milestone, supported by approvals from both Health Canada and the Therapeutic Goods Administration, underscores the trust in our GMP manufacturing processes and the growing demand for these transformative therapies.
"Following recent purchase orders, the Company has updated its 2025 production forecast to supply enough MDMA capsules for over 5,000 patients globally, ensuring our customers and patients alike have consistent and reliable access to MDMA-assisted therapy," Stevens added.
Partnership with Mind Medicine Australia
"This milestone highlights the growing confidence in MDMA-assisted therapy as an effective treatment for PTSD," said Peter Hunt, Chairman of Mind Medicine Australia. "Through our partnership with Optimi Health, we are ensuring that practitioners have the tools, resources, and tailored training needed to safely deliver these therapies while also collecting vital real-world data to guide global mental health strategies.
"This partnership furthers our charitable mission by making medicines available to patients at the best possible price, promoting equitable access for all. By prioritizing affordability and quality, we are setting a strong foundation for the future of mental health treatment."
Global Context
PTSD affects millions worldwide, including 6% of U.S. adults during their lifetime (PTSD.va.gov). The economic burden in the U.S. alone is estimated at $232 billion annually (ScienceDaily). Optimi's efforts in Australia provide a scalable model for addressing this unmet need and supporting the global adoption of psychedelic-assisted therapies. By leading advancements in Australia, Optimi is paving the way for global adoption and improved mental health outcomes worldwide.
Access for Authorised Prescribers in Australia
Healthcare professionals and Authorised Prescribers seeking access to Optimi's GMP MDMA and psilocybin products can contact Mind Medicine Australia via their website.
About Optimi Health Corp.
Optimi Health Corp. is a Health Canada-licensed, GMP-compliant manufacturer and supplier of natural psilocybin and MDMA. The Company focuses on scalable production and distribution to regulated markets, including the development of innovative psychedelic products to support the mental health and wellness of patients worldwide. Optimi is dedicated to advancing psychedelic therapies with a commitment to quality, compliance, and accessibility.
On behalf of the Board of Directors, OPTIMI HEALTH CORP.
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements") that relate to Optimi's current expectations and views of future events. 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. 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.
