Optimi Health Provides Corporate Update

Rhea-AI Summary

Optimi Health (OTCQX: OPTHF), a GMP-compliant manufacturer of botanical psilocybin and MDMA, has announced several key developments. The company has secured additional import permits for 1,000 doses of GMP MDMA capsules in Australia, following previous shipments of 860 doses in 2024.

The company obtained a important BICON import permit for natural psilocybin extract capsules in Australia, enabling authorized prescribers to access their treatment for resistant depression. A partnership with ATMA CENA Healthcare Solutions has been established for Phase 2 clinical trials, testing psilocybin-assisted therapy for major depressive disorder in 200 patients, with dosing beginning Q2 2025.

Optimi recently completed a harvest of high-potency Psilocybe cubensis for GMP extraction and 5mg dose encapsulation. The company maintains over 200 natural psilocybin genetic varieties. Additionally, Optimi will issue 100,000 common shares for advisory services and settle $20,000 in fees through share issuance, both subject to a four-month hold period.

Positive

• Secured permits for 1,000 additional MDMA doses in Australia, expanding international market presence
• Obtained BICON approval for psilocybin imports to Australia, opening new revenue stream
• Initiated 200-patient Phase 2 clinical trial for psilocybin therapy
• Completed harvest of high-potency Psilocybe cubensis for GMP production
• Maintains extensive bank of 200+ psilocybin genetic varieties

Negative

• Share dilution through issuance of 100,000 new shares for services
• Additional dilution from $20,000 debt settlement through share issuance

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.

Share Transactions

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

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.com. 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/244300

FAQ

What is the significance of Optimi Health's new Australian MDMA import permits for OPTHF stock?

The permits allow Optimi to export 1,000 additional doses of GMP MDMA capsules to Australia, expanding their market presence and revenue potential following previous successful shipments totaling 860 doses in 2024.

How many patients will be involved in Optimi Health's Phase 2 psilocybin clinical trial?

The Phase 2 clinical trial with ATMA CENA will evaluate psilocybin-assisted therapy for major depressive disorder in 200 patients, starting Q2 2025.

What is the size of Optimi Health's psilocybin genetics bank?

Optimi maintains one of the world's largest banks of natural psilocybin genetics, with over 200 varieties on-site for pharmaceutical and clinical applications.

How many shares will Optimi Health issue for advisory services in March 2025?

Optimi will issue 100,000 common shares at market price for advisory services, subject to a four-month hold period.