Optimi Health names clinical chief for psychedelic trials

Optimi Health creates a new Chief Clinical Development Officer role to strengthen oversight of planned psilocybin and MDMA trials.

Rhea-AI Filing Summary

Optimi Health Corp. (OPTH) reported the appointment of Michael Blough, Ph.D. as Chief Clinical Development Officer, a newly created role overseeing clinical development strategy and operations. He has worked with Optimi on Health Canada-authorized clinical trial applications since 2022.

Dr. Blough will lead protocol execution, site activation, regulatory interactions, and data generation for Optimi’s planned Phase 2 psilocybin-assisted psychotherapy trial in major depressive disorder and Phase 3 MDMA-assisted psychotherapy trial in PTSD. He brings more than 20 years of research experience, including leadership of multiple psychedelic clinical trials and extensive work in brain cancer research. Optimi highlights this hire as support for advancing its psychedelic drug products toward potential registration and broader therapeutic use.

Key Figures

Research experience: More than 20 years Psilocybin trial phase: Phase 2 MDMA trial phase: Phase 3 +3 more

6 metrics

Research experience More than 20 years Dr. Blough’s experience directing research programs and clinical trials

Psilocybin trial phase Phase 2 Planned psilocybin-assisted psychotherapy trial for major depressive disorder

MDMA trial phase Phase 3 Planned MDMA-assisted psychotherapy trial for PTSD

Brain cancer research tenure 15 years Time spent in brain cancer research before focusing on psychedelic medicine

Peer-reviewed papers on glioblastoma Over 30 Publications on glioblastoma and therapeutic response mechanisms

National initiative duration Seven years Terry Fox Research Institute-funded project to identify new glioblastoma treatments

Key Terms

Phase 2 clinical trial, Phase 3 clinical trial, psilocybin-assisted psychotherapy, MDMA-assisted psychotherapy, +2 more

6 terms

Phase 2 clinical trial medical

"the Company’s planned Phase 2 clinical trial evaluating naturally derived psilocybin-assisted"

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.

Phase 3 clinical trial medical

"the Phase 3 clinical trial evaluating MDMA-assisted psychotherapy for the treatment of PTSD"

A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.

psilocybin-assisted psychotherapy medical

"Phase 2 clinical trial evaluating naturally derived psilocybin-assisted psychotherapy to treat"

A treatment approach that combines a guided course of psychotherapy with supervised doses of psilocybin, the active compound found in certain mushrooms. Investors care because it pairs a novel drug with a structured service model—like pairing a new tool with professional training—so clinical trial results, regulatory approval, and the ability to scale trained providers directly affect potential market size, reimbursement and business risk.

MDMA-assisted psychotherapy medical

"Phase 3 clinical trial evaluating MDMA-assisted psychotherapy for the treatment of PTSD"

Special Access Program regulatory

"accessible in Canada through the 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

"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 executive appointment did Optimi Health Corp. (OPTH) announce?

Optimi Health Corp. announced the appointment of Michael Blough, Ph.D. as its new Chief Clinical Development Officer, a role overseeing clinical development strategy, protocol execution, site activation, and Health Canada interactions for its psychedelic drug trials.

What clinical trials will the new Chief Clinical Development Officer at OPTH oversee?

He will oversee Optimi’s planned Phase 2 clinical trial of naturally derived psilocybin-assisted psychotherapy for major depressive disorder and a Phase 3 clinical trial of MDMA-assisted psychotherapy for the treatment of PTSD.

What relevant experience does Dr. Michael Blough bring to Optimi Health (OPTH)?

Dr. Blough has more than 20 years of research experience, including directing bench science, pre-clinical studies, and clinical trials, leading multiple Health Canada-authorized psilocybin and MDMA trials, and 15 years in brain cancer research with over 30 peer-reviewed papers on glioblastoma.

How does this appointment relate to Optimi Health’s (OPTH) regulatory strategy?

Dr. Blough will manage Health Canada interactions and oversee datasets intended to support registration of Optimi’s psychedelic drug products, aligning clinical trial design, regulatory approvals, and data generation with the company’s commercialization plans.

What psychedelic products and markets does Optimi Health Corp. (OPTH) focus on?

Optimi is a commercial-stage pharmaceutical company manufacturing GMP-grade MDMA and botanical psilocybin in British Columbia. It supplies active ingredients and finished dosage forms to regulated programs internationally, including prescriptions in Australia’s Authorized Prescriber Scheme and access in Canada via the Special Access Program.

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

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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 22, 2026		/s/ Dane Stevens
		Dane Stevens
		Chief Executive Officer, Chief Marketing Officer and Director

EXHIBIT 99.1

 

Optimi Health Appoints Dr. Michael Blough as Chief Clinical Development Officer

Supports Optimi’s planned Phase 2 psilocybin trial in major depressive disorder and Phase 3 MDMA trial in PTSD

VANCOUVER, British Columbia, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) ("Optimi" or the "Company"), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today announced the appointment of Michael Blough, Ph.D., as Chief Clinical Development Officer.

Dr. Blough has significant experience leading Health Canada-authorized clinical trials and has worked with Optimi on clinical trial applications since 2022. In this newly created position, he will oversee Optimi’s clinical development strategy and related operations. This includes the Company’s planned Phase 2 clinical trial evaluating naturally derived psilocybin-assisted psychotherapy to treat patients with major depressive disorder and the Phase 3 clinical trial evaluating MDMA-assisted psychotherapy for the treatment of PTSD. Dr. Blough will be responsible for protocol execution, site activation, Health Canada interactions, and the datasets the Company intends to use to support registration of its drug products.

"Michael brings to Optimi a valuable combination of clinical trial expertise in psychedelics, a strong working relationship with Health Canada, and a commitment to scientific rigor at a pivotal moment for our Company. His experience running psychedelic trials in Canada, combined with years of collaborating with our team, positions him well to advance our Phase 2 psilocybin trial in major depressive disorder and our Phase 3 MDMA trial in PTSD," said Dane Stevens, Optimi Chief Executive Officer and Co-Founder. “With both trials expected to begin enrolling patients next year, this timely appointment strengthens our ability to generate the data to bring these treatments to the underserved patient populations who need them most."

Dr. Blough is a medical researcher with more than 20 years of experience directing research programs spanning bench science, pre-clinical studies, and clinical trials. His work has included leading the development and Health Canada authorization of multiple clinical trials evaluating psilocybin and MDMA for mental health conditions including post-traumatic stress disorder and treatment-resistant depression. Before moving into psychedelic medicine, he spent 15 years in brain cancer research, publishing over 30 peer-reviewed papers on glioblastoma and the molecular mechanisms of therapeutic response, as well as leading a seven-year national initiative funded by the Terry Fox Research Institute to identify new treatments for the disease.

"Working closely with the Optimi team, I've seen firsthand the quality and care they bring to psychedelic drug manufacturing and clinical development. Joining as Chief Clinical Development Officer lets me bring my experience in protocol design, regulatory approval, and trial management to two of the most important studies in our field right now. I look forward to working with Health Canada and our clinical sites to move these trials forward for patients with major depressive disorder and for veterans and front-line workers living with PTSD," said Dr. Blough.

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 potential benefits of psilocybin and MDMA, 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 8.1 KB