Optimi Health launches psilocybin microdose products

Optimi Health Corp. filed a Form 6-K highlighting the launch of two standardized microdose psilocybin capsule products for clinical research, formulated at 1 mg and 2 mg.

Rhea-AI Filing Summary

Optimi Health Corp. filed a Form 6-K highlighting the launch of two standardized microdose psilocybin capsule products for clinical research, formulated at 1 mg and 2 mg. These naturally derived, GMP-manufactured finished drug products are designed to give research organizations consistent, validated doses for controlled microdosing studies.

The new formats expand Optimi’s psilocybin range alongside its existing 5 mg capsule, which is commercially prescribed for treatment-resistant depression in Australia under the Authorized Prescriber Scheme. Optimi manufactures the products end-to-end at its Health Canada-licensed GMP facility in Princeton, British Columbia, and supplies psilocybin and MDMA products to regulated clinical and therapeutic programs internationally.

Key Figures

Microdose strength 1: 1 mg psilocybin Microdose strength 2: 2 mg psilocybin Existing capsule strength: 5 mg psilocybin +3 more

6 metrics

Microdose strength 1 1 mg psilocybin New finished drug product dosage for microdosing research

Microdose strength 2 2 mg psilocybin New finished drug product dosage for microdosing research

Existing capsule strength 5 mg psilocybin Currently prescribed in Australia for treatment-resistant depression

Fadiman protocol pattern 1 day on, 2 days off Example microdosing regimen mentioned for psychedelics

Stamets protocol pattern 4 days on, 3 days off Example microdosing regimen mentioned for psychedelics

Head office phone 778-761-4551 CEO contact number in company information

Key Terms

microdosing, Authorized Prescriber Scheme, Special Access Program, Drug Establishment License (DEL), +1 more

5 terms

microdosing medical

"Microdosing refers to taking low, sub-perceptual doses of a psychedelic on a repeated schedule."

Microdosing is the practice of giving people very small, sub‑therapeutic amounts of a drug—often a fraction of a typical dose—aimed at producing subtle benefits without the full effects or side effects of a standard dose. For investors, microdosing matters because it can change the safety profile, required testing, regulatory pathway and market appeal of a drug program; think of it like adding a tiny amount of seasoning to a recipe to alter flavor without changing the whole dish.

Authorized Prescriber Scheme regulatory

"5 mg capsule formulation currently prescribed for treatment-resistant depression 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.

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.

Drug Establishment License (DEL) regulatory

"under its Health Canada Drug Establishment License (DEL)."

A drug establishment license (DEL) is an official permit that allows a company’s facility to manufacture, store or distribute pharmaceutical products under a regulator’s safety and quality rules. Think of it like a health department permit for a commercial kitchen: without it the facility cannot legally operate, and having one signals to investors that the business meets regulatory standards, reducing the risk of shutdowns, fines or product recalls.

GMP pharmaceutical manufacturer technical

"a commercial-stage GMP pharmaceutical manufacturer of regulated psychedelic drug products"

FAQ

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

What new products did Optimi Health (OPTH) introduce in this Form 6-K?

Optimi Health introduced two standardized microdose psilocybin capsule products at 1 mg and 2 mg. These finished drug products target qualified clinical research organizations needing consistent, validated low doses for controlled psychedelic microdosing studies.

How do Optimi Health’s new psilocybin microdose products support clinical research?

The capsules deliver naturally derived psilocybin at a validated, consistent dose, replacing variable dried mushrooms. This consistency helps clinical researchers design controlled studies using defined microdosing regimens, such as Fadiman or Stamets-style schedules with built-in rest days.

What existing psilocybin product does Optimi Health (OPTH) already supply?

Optimi already offers a 5 mg psilocybin capsule that is commercially prescribed in Australia for treatment-resistant depression under the country’s Authorized Prescriber Scheme. The new 1 mg and 2 mg microdose products extend this existing psilocybin product range.

Where are Optimi Health’s new psilocybin microdose capsules manufactured?

Optimi manufactures the microdose psilocybin capsules at its GMP-compliant facility in Princeton, British Columbia. The company cultivates mushrooms, produces a full-spectrum extract API, then formulates, encapsulates, and packages finished products under a Health Canada Drug Establishment License.

Who can access Optimi Health’s new microdose psilocybin products?

The new 1 mg and 2 mg psilocybin finished drug products are available to qualified, authorized clinical research organizations. Optimi supplies these products internationally to regulated markets, supporting both clinical trials and patient access programs where legally permitted.

What therapeutic programs currently use Optimi Health’s psychedelic drug products?

Optimi supplies GMP-grade psilocybin and MDMA to regulated clinical and therapeutic programs internationally. Its products are prescribed to patients in Australia under the Authorized Prescriber Scheme and are accessible in Canada through the federal Special Access Program framework.

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

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Accepted by SEC EDGAR 06/16/2026 - 08:30 AM EDT Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13A-16 OR 15D-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of June

Commission File Number: 001-43304

OPTIMI HEALTH CORP.

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 ☒   Form 40-F ☐

EXHIBIT INDEX

Exhibit		Description of Exhibit
99.1		Press Release

SIGNATURE

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

				OPTIMI HEALTH CORP.
Date: June 16, 2026				By:		/s/ Dane Stevens
				Name:		Dane Stevens
				Title:		Chief Executive Officer, Chief Marketing Officer and Director

Exhibit 99.1

Optimi Health Launches Standardized Microdose Psilocybin Products for Clinical Research

Two naturally derived finished drug products, at 1mg and 2mg, give research organizations the consistent, validated doses required for controlled studies

New microdose formats extend Optimi’s psilocybin range, which includes a 5mg formulation currently commercially prescribed for treatment-resistant depression in Australia under the country’s Authorized Prescriber Scheme

VANCOUVER, British Columbia, June 16, 2026 – via GlobeNewswire – Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) (the “Company” or “Optimi”), a commercial-stage GMP pharmaceutical manufacturer of regulated psychedelic drug products, today announced it has completed production of two microdose psilocybin finished drug products, formulated at 1 mg and 2 mg dosages. The products are available to qualified, authorized clinical research organizations.

Microdosing refers to taking low, sub-perceptual doses of a psychedelic on a repeated schedule. Common regimens include the Fadiman protocol (one day on, two days off) and the Stamets protocol (four days on, three days off), which build in rest days to limit tolerance.

CEO and Co-Founder Dane Stevens said: “Most microdosing relies on dried mushrooms, whose psilocybin content varies widely from batch to batch. Optimi’s capsules instead deliver naturally derived psilocybin at a validated, consistent dose, pairing the natural source many researchers prefer with the accurate dosage that controlled research requires. The 1mg and 2mg dosage formats extend Optimi’s psilocybin range, which already includes the 5 mg capsule formulation currently prescribed for treatment-resistant depression in Australia.”

Optimi produces these products start to finish in-house, cultivating and harvesting the mushrooms, generating a full-spectrum mushroom extract as the active pharmaceutical ingredient (API), and formulating, encapsulating, and packaging the finished product for export to clinical research organizations. Every stage is completed on-site Optimi’s wholly owned GMP facility in Princeton, British Columbia, Canada, under its Health Canada Drug Establishment License (DEL).

Optimi supplies finished psilocybin and MDMA drug products to regulated markets internationally, supporting both patient access and clinical research. Inquiries about product supply for special access programs and clinical trials may be directed to sales@optimihealth.ca.

About Optimi Health Corp.

Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) 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 www.optimihealth.ca or 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:

Lucas A. Zimmerman

Managing Director

MZ Group - MZ North America

(262) 357-2918

OPTHF@mzgroup.us

www.mzgroup.us

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 availability, intended use and potential benefits of the Company’s 1 mg and 2 mg microdose psilocybin finished drug products, the Company’s ability to supply finished psilocybin and MDMA drug products and other psychedelic drug products to qualified, authorized clinical research organizations and regulated markets internationally; the anticipated demand for, benefits of and commercial opportunities associated with the Company’s psilocybin product portfolio and supply operations; the Company’s ability to maintain applicable licenses, authorizations and regulatory approvals; and the Company’s ability to support patient access, special access programs, authorized prescriber programs and clinical research. Forward-looking statements are often identified by words such as “expects,” “anticipates,” “believes,” “intends,” “plans,” “estimates,” “seeks,” “may,” “will,” “would,” “could,” or similar expressions. Forward-looking statements are based on a number of assumptions and estimates 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 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.

InvestorWire Service Contact:

IBN

Austin, Texas

www.InvestorBrandNetwork.com

512.354.7000 Office

Editor@InvestorBrandNetwork.com

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EX-99.1 11.8 KB