Optimi Health plans 200-patient psilocybin MDD trial

Optimi Health is moving into clinical drug development with a large Phase 2 psilocybin trial in major depressive disorder, fully funded from existing cash.

Rhea-AI Filing Summary

Optimi Health Corp. (OPTH) plans to launch a multisite Phase 2 clinical trial of psilocybin-assisted therapy for major depressive disorder (MDD) in the first half of 2027, with dosing expected to be completed by the end of 2027. The Health Canada–authorized study will enroll up to 200 participants across multiple Canadian sites and test the safety and efficacy of a single supervised dose of naturally derived psilocybin. The primary efficacy endpoint is change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline. Optimi will supply its own GMP-manufactured psilocybin, retain exclusive ownership of trial results, and states it can comfortably fund the trial with current cash on hand.

Positive

• Advances into Phase 2 clinical development with a Health Canada–authorized, multisite trial in major depressive disorder, signaling a step toward potential registration of its psilocybin-assisted therapy.
• Large planned sample size of up to 200 participants makes this among the larger studies of naturally derived psilocybin, potentially providing more robust safety and efficacy data.
• Trial funded with current cash on hand, reducing near-term financing risk for this clinical milestone according to the company’s statement.

Negative

• None.

Filing Explained

The study is authorized but not yet underway, and Optimi still lacks Health Canada market authorization for its psilocybin products.

Under Form 6-K, a foreign private issuer furnishes material information published in its home market. Optimi Health reports that Health Canada has authorized its planned Phase 2 trial to proceed, but initiation remains planned for the first half of 2027; the disclosed consequence is advancement toward clinical development, not a completed trial or a market-authorized product.

The authorization covers the study itself: the company separately states that none of its psilocybin products has received Health Canada market authorization.

The company expects periodic interim safety and efficacy readouts, while full topline results are expected only after dosing and follow-up evaluations for all 200 participants are completed.

The next specified milestones are trial initiation in the first half of 2027 and expected dosing completion by the end of 2027; full results remain dependent on subsequent dosing and follow-up.

Key Figures

Planned trial participants: Up to 200 participants Trial initiation timing: First half of 2027 Dosing completion target: End of 2027 +1 more

4 metrics

Planned trial participants Up to 200 participants Maximum enrollment for the Phase 2 psilocybin-assisted therapy trial in MDD

Trial initiation timing First half of 2027 Planned start of the Phase 2 clinical trial

Dosing completion target End of 2027 Expected timing for completion of dosing in the Phase 2 trial

Global MDD prevalence 332 million people Estimated number of people affected by major depressive disorder worldwide, per WHO 2025 fact sheet

Key Terms

Phase 2 clinical trial, psilocybin-assisted therapy, Montgomery-Åsberg Depression Rating Scale (MADRS), Drug Establishment Licence, +2 more

6 terms

Phase 2 clinical trial medical

"plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy"

A phase 2 clinical trial is a research study that tests a new medical treatment or drug to see if it is effective and safe for a specific condition. It involves a larger group of people than earlier trials and helps determine whether the treatment should move forward to more extensive testing. For investors, successful phase 2 results can signal potential for future approval and commercial success, while setbacks may indicate challenges ahead.

psilocybin-assisted therapy medical

"Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder"

Psilocybin-assisted therapy combines a controlled dose of psilocybin, the active compound in certain mushrooms, with supervised psychological support to help treat mental health conditions such as depression or PTSD; sessions follow clinical protocols and are delivered by trained professionals. It matters to investors because successful clinical results, regulatory approvals, and reimbursement decisions can create new markets and revenue streams, while failures, safety concerns, or slow approvals can sharply reduce a company’s value—think of the drug as a tool and the therapy as the trained coach that makes it useful.

Montgomery-Åsberg Depression Rating Scale (MADRS) medical

"The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS)"

A 10-question clinician-rated scale that measures the severity of depressive symptoms and tracks changes over time, often used in clinical trials as a standardized “thermometer” for depression. Investors watch MADRS results because improvements or lack of change can drive trial success, regulatory decisions and ultimately a drug’s commercial prospects, much like an exam score signals whether a new product meets expectations.

Drug Establishment Licence regulatory

"In Canada, we already hold a Drug Establishment Licence and supply psilocybin"

Special Access Program regulatory

"psilocybin through Health Canada's Special Access Program"

A special access program is a regulated pathway that lets patients use an experimental drug, vaccine, or medical device outside clinical trials when no approved options are available. Think of it like allowing a small number of people to try a prototype product before wide release; for investors it can create early, limited revenue, generate real‑world safety and use data, and carry regulatory and reputational risks that can affect a company’s valuation.

Authorized Prescriber Scheme regulatory

"products currently prescribed to patients in Australia under the country’s Authorized Prescriber Scheme"

An authorized prescriber scheme lets a qualified clinician or group of clinicians prescribe a specific medicine to eligible patients without obtaining individual approvals each time, under rules set by health regulators. For investors, it matters because the scheme can speed access to medicines and broaden sales once clinicians are approved, similar to giving a trusted shopkeeper a standing license to sell a product rather than requiring a new permit for every sale.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What clinical trial did Optimi Health (OPTH) announce on this Form 6-K?

Optimi Health announced plans for a multisite Phase 2 clinical trial of psilocybin-assisted therapy in individuals with major depressive disorder, using a single supervised dose of naturally derived psilocybin at sites across Canada.

How many participants will be enrolled in Optimi Health’s Phase 2 psilocybin trial?

The Phase 2 trial is expected to enroll up to 200 participants across multiple sites in Canada, making it one of the larger clinical studies of naturally derived psilocybin reported to date.

When will Optimi Health’s (OPTH) Phase 2 psilocybin trial start and finish dosing?

The company plans to initiate the trial in the first half of 2027, with dosing expected to be completed by the end of 2027, followed by follow-up evaluations and topline data.

What is the primary endpoint of Optimi Health’s Phase 2 MDD trial?

The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline, a widely used clinician-rated measure of depressive symptom severity in similar trials.

Does Optimi Health currently have market authorization for its psilocybin products?

No. The company states that the safety and efficacy of psilocybin-assisted therapy for MDD remain under investigation and that none of its psilocybin drug products has received market authorization by Health Canada.

How is Optimi Health currently using its psychedelic products commercially?

Optimi manufactures GMP-grade psilocybin and MDMA and supplies them as active ingredients and finished dosage forms to regulated programs, including prescriptions in Australia’s Authorized Prescriber Scheme and access in Canada through the Special Access Program.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/10/2026 - 08:45 AM Accepted by SEC EDGAR 09/10/2026 - 08:45 AM Learn about SEC filing dates

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of September 2026

Commission File Number: 001-43304

Optimi Health Corp.
(Translation of registrant's name into English)

269 David Brown Way
Princeton, B.C. V0X 1W0
Canada
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

EXHIBIT INDEX

Exhibit		Description of Exhibit
99.1		Press Release

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		Optimi Health Corp.
		(Registrant)
Date: September 10, 2026		/s/ Dane Stevens
		Dane Stevens
		Chief Executive Officer, Chief Marketing Officer and Director

EXHIBIT 99.1

 

Optimi Health to Initiate Phase 2 Clinical Trial Evaluating Psilocybin-Assisted Therapy for Major Depressive Disorder

Health Canada-authorized trial to evaluate a single supervised dose of natural psilocybin, with dosing expected to be completed by the end of 2027

Up to 200 participants at sites across Canada, among the largest studies of naturally derived psilocybin to date

VANCOUVER, British Columbia, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Optimi Health Corp. (Nasdaq: OPTH) (“Optimi” or the “Company”), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder ("MDD"). The trial is planned to be initiated in the first half of 2027, with dosing expected to be complete by the end of 2027.

The Phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline, the most widely used clinician-rated measure of depressive symptom severity in trials of this kind.

"A 200-subject Phase 2 trial in major depressive disorder is the largest clinical commitment Optimi has made to date. We will supply our own naturally derived psilocybin, manufactured at our GMP facility, and we will have exclusive ownership of the trial results," said Dane Stevens, Optimi Chief Executive Officer and Co-Founder. "As we broaden our strategy to include clinical drug development, this Phase 2 trial is an initial step toward potential registration. Few companies in this sector are commercial today while also advancing their own clinical development. In Canada, we already hold a Drug Establishment Licence and supply psilocybin through Health Canada's Special Access Program. This trial builds directly on that foundation, and we can comfortably fund it with current cash on hand."

The clinical trial is set to be one of the largest clinical studies of naturally derived psilocybin to date, and will include periodic interim safety and efficacy readouts, with full topline results available after dosing and follow-up evaluations are completed for all 200 participants.

MDD is among the most common mental health conditions worldwide, affecting an estimated 332 million people, according to the World Health Organization.¹ A substantial proportion of patients do not respond adequately to existing antidepressant treatments, which typically require weeks of continuous use before clinical benefits emerge.

¹World Health Organization, Depressive disorder (depression) fact sheet, 2025. Available at: https://www.who.int/news-room/fact-sheets/detail/depression

The safety and efficacy of psilocybin assisted therapy to treat MDD is still under investigation and none of Optimi’s psilocybin drug products received market authorization by Health Canada.

About Optimi Health Corp.

Optimi Health Corp. is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. Optimi supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country’s Authorized Prescriber Scheme and accessible in Canada through the Special Access Program.

For more information, please visit optimi.net.

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

Investor Relations Contact:
CORE IR
ir@optimi.net

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, including statements regarding the proposed clinical trial, the availability and enrolment of patients in the trial, the utilization of the data derived from the trial, and the ability to conduct evaluations as part of the trial, the Company’s ability to manufacture and ship products from its Canadian facility, and the Company’s positioning in the regulated psychedelic medicine market. Forward-looking statements and forward-looking information are often identified by words such as “expects,” “anticipates,” “believes,” “intends,” “plans,” “estimates,” “may,” “will,” “would,” “could,” or similar expressions. Forward-looking statements and forward-looking information are based on several assumptions and are subject to a number of known and unknown 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. Accordingly, there are or will be important factors that may cause actual results to differ from expected results. These factors include those described under “Risk Factors” in the Company’s registration statement on Form F-1, as amended, and other filings with the U.S. Securities and Exchange Commission made from time to time which are available at www.sec.gov and on SEDAR+ at www.sedarplus.ca and in the Company’s continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. These forward-looking statements reflect current expectations of management regarding future events and speak only as of the date of this press release. 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. 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 press 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.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE 8.0 KB