Optimi Health Provides Corporate Update

Rhea-AI Summary

Optimi Health (OTCQX: OPTHF) announced it passed a Health Canada Drug Establishment Licence inspection with no critical observations, receiving a GMP-compliant rating to fabricate, label, package, distribute and wholesale pharmaceutical-grade psychedelic finished drug products and APIs.

The Company stated its MDMA capsules for PTSD and psilocybin capsules for treatment-resistant depression are being prescribed in Australia under the Authorized Prescriber Scheme. Optimi also signed a market‑making agreement with Independent Trading Group on Sept 30, 2025, subject to CSE approval, at CDN$6,500 per month with automatic one‑month renewals.

Positive

• Health Canada DEL with GMP-compliant rating, no critical observations
• Authorized prescriptions in Australia for MDMA and psilocybin capsules
• Market-making agreement aims to improve liquidity on the CSE

Negative

• Market-maker compensation is fixed at CDN$6,500 per month
• Agreement contains no performance-based incentives for liquidity
• Finished drug prescriptions currently limited to Australia under Authorized Prescriber Scheme

Vancouver, British Columbia--(Newsfile Corp. - October 21, 2025) -  Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of pharmaceutical psychedelics including MDMA and naturally-derived psilocybin, is pleased to announce that it has passed its Drug Establishment Licence (DEL) inspection by Health Canada, with no critical observations, resulting in a GMP-compliant rating for the fabrication and distribution of pharmaceutical-grade psychedelic finished drug products and active pharmaceutical ingredients (API).

This certification formally authorizes Optimi to perform the following activities under its DEL:

Fabricate (API and Pharmaceutical)
Label (API and Pharmaceutical)
Package (API and Pharmaceutical)
Distribute (Pharmaceutical)
Wholesale (Prescription Drug List, Schedule G, and/or Narcotics, or a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act)

The finished psychedelic drug products manufactured under the Company's Drug Establishment Licence, including MDMA capsules for the treatment of Post-Traumatic Stress Disorder (PTSD) and psilocybin capsules for the treatment of Treatment-Resistant Depression (TRD), are currently being prescribed to patients in Australia under the Authorized Prescriber Scheme.

The Company also announces that it has entered into a market making service agreement (the "Agreement") with Independent Trading Group ("ITG") dated September 30, 2025, subject to approval by the Canadian Securities Exchange (the "CSE"). Under the Agreement, ITG will provide market-making services in accordance with CSE policies, trading shares of the Company on the CSE and other trading venues with the objective of maintaining an orderly market and improving the liquidity of Optimi's common shares. ITG will receive compensation of CDN$6,500 per month. The Agreement has an initial one-month term and will automatically renew for successive one-month periods unless terminated by either party with 30 days' notice. The Agreement contains no performance-based factors, and ITG will not receive shares or options as compensation. ITG and the Company are unrelated and unaffiliated entities, and at the time of the Agreement, neither ITG nor its principals hold any direct or indirect interest in the securities of the Company.

How to Access Optimi's MDMA and Psilocybin Capsules

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

For Authorized Prescribers in Australia, please contact Mind Medicine Australia at medicines@mindmedicineaustralia.org.

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

About Optimi Health Corp.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi") is a Canadian Good Manufacturing Practices ("GMP") compliant, pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. From two 10,000-square-foot facilities in British Columbia and operating under a Drug Establishment License from Health Canada, 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"), including with respect to the role of psychedelic medicines in insured mental health care. 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 the Company'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 continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. Except as expressly required by applicable law, the Company 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 the Company 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/271090

FAQ

What did Optimi Health (OPTHF) receive from Health Canada on October 21, 2025?

Optimi received a Drug Establishment Licence (DEL) with a GMP-compliant rating and no critical observations.

What activities does Optimi's Health Canada DEL authorize for OPTHF?

The DEL authorizes Optimi to fabricate, label, package, distribute pharmaceutical APIs and finished drug products and to wholesale listed prescription drugs.

Are Optimi's MDMA and psilocybin products being prescribed now for patients?

Yes; the release says MDMA capsules for PTSD and psilocybin capsules for TRD are currently prescribed in Australia under the Authorized Prescriber Scheme.

What are the terms of Optimi's market-making agreement with ITG for OPTHF shares?

The agreement dated Sept 30, 2025 pays ITG CDN$6,500/month, has one‑month initial term with automatic monthly renewals, and is subject to CSE approval.

Will ITG receive shares or options as compensation under the OPTHF market‑making agreement?

No; the company disclosed ITG will not receive shares or options and the parties are unrelated.