Vancouver, British Columbia–(Newsfile Corp. – March 12, 2025) – Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) (“Optimi” or the “Company“), a GMP-compliant, Health Canada-licensed manufacturer specializing in botanical psilocybin and MDMA, is pleased to provide the following corporate update, highlighting key regulatory milestones, clinical trial progress, and expanded market access.
Expansion of MDMA Exports to the Australian Market
Optimi has received additional import permits for 1,000 doses of its GMP MDMA in 40mg and 60mg capsule formulations. This follows earlier shipments of 160 doses in August 2024, and 700 doses in October 2024, highlighting the expanding use of MDMA-assisted therapy and growing confidence in Optimi’s pharmaceutical-grade capsules throughout Australia.
Regulatory Progress: Australian BICON Permit Granted for Psilocybin Import
Optimi has obtained the necessary BICON import permit for its natural psilocybin extract capsules, enabling their legal entry into Australia.
BICON (Biosecurity Import Conditions) is an Australian regulatory framework governing the importation of biological materials to ensure compliance with strict biosecurity and safety standards. Securing this permit is a key milestone, particularly for botanical-derived products like natural psilocybin, and reinforces Optimi’s ability to meet international pharmaceutical requirements.
With this approval, Authorized prescribers in Australia can now access Optimi’s natural psilocybin for treatment-resistant depression (TRD), expanding therapeutic options for patients who have not responded to conventional treatments.
ATMA CENA Partnership: Advancing Phase 2 & Phase 3 Psilocybin Clinical Trials
Optimi has finalized a supply agreement with ATMA CENA Healthcare Solutions to provide its GMP psilocybin extract capsules for a Phase 2 clinical trial evaluating psilocybin-assisted therapy for major depressive disorder (MDD) in 200 patients.
The trial is set to begin patient dosing in Q2 2025, with cohorts enrolling throughout the year.
Additionally, Optimi is working with ATMA CENA on a Phase 3 trial submission, representing a key step toward broader regulatory approvals for its natural psilocybin drug candidate within Canada.
Psilocybin Production and Clinical Trial Supply Updates
The Company recently completed a significant harvest of its genetically isolated, high-potency Psilocybe cubensis. This biomass will undergo Optimi’s validated GMP extraction process later this month to optimize potency and ensure pharmaceutical-grade consistency ahead of encapsulation.
The extracted active pharmaceutical ingredient (API) will be encapsulated into 5mg doses to support upcoming clinical trial initiatives in Canada and facilitate international distribution to Australia, Asia, and Europe.
To date, Optimi maintains one of the most extensive banks of natural psilocybin genetics in the world, with over 200 varieties on-site. This diverse genetic library allows the Company to refine and develop optimized psilocybin formulations tailored for pharmaceutical and clinical applications.
Optimi has finalized an advisory agreement to secure specialized expertise in business development and corporate strategy. In consideration of past services, the Company will issue 100,000 common shares at a deemed price per share equal to the closing price on the Canadian Securities Exchange (CSE) on the last trading day prior to issuance. The shares will be subject to a hold period of four months and one day from the date of issuance.
Additionally, the Company is settling $20,000 in outstanding service fees by issuing common shares at a deemed price per share equal to the closing price on the CSE on the last trading day prior to issuance. The shares will be subject to a four-month and one-day hold period.
Both share transactions are expected to be completed on or around March 19, 2025.
How to Access Optimi’s MDMA and Psilocybin Capsules
Australia: Mind Medicine Australia
Global Inquiries: sales@optimihealth.ca
About Optimi Health Corp.
Optimi Health Corp. is a Health Canada-licensed, GMP-compliant manufacturer and supplier of natural psilocybin and MDMA. Dedicated to producing high-quality psychedelic products, the Company aims to support the global advancement of mental health therapies through rigorous compliance, innovation, and collaboration.
On Behalf of the Board
JJ Wilson, Chair of the Board
For more information, please contact:
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca