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Optimi Health (OPTHF) advances 6% psilocybin extract for TRD use

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Optimi Health Corp. reported a manufacturing milestone with completion of a production run of naturally derived psilocybin extract containing approximately 6% psilocybin, the highest-purity botanical extract the company has produced so far. This reflects gains in its mushroom cultivation program and extraction process.

A portion of this higher-purity extract is earmarked for upcoming sponsor-led clinical research programs in Europe, while the remainder supports ongoing product development and future regulated supply. The milestone also strengthens Optimi’s commercial supply of naturally derived 5 mg psilocybin capsules for treatment-resistant depression under Australia’s Authorised Prescriber Scheme, where aggregated data show no serious adverse events as of December 2025.

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Psilocybin extract purity 6% psilocybin content Highest-purity naturally derived botanical extract produced by Optimi to date
Mushroom genetics library More than 200 distinct genetics Proprietary mushroom genetics maintained at Optimi’s facilities
Psilocybin capsule strength 5 mg psilocybin per capsule Naturally derived capsules prescribed in Australia for treatment-resistant depression
Australian safety data cutoff December 2025 No serious adverse events reported under Authorised Prescriber Scheme as of this date
Supply start to Australia September 2025 Date since which Optimi has supplied psilocybin finished products to the Scheme
Form type Form 6-K Report of foreign private issuer with attached press release
Authorised Prescriber Scheme regulatory
"being prescribed for treatment-resistant depression under the Therapeutic Goods Administration’s Authorised Prescriber Scheme"
A government-authorised prescriber scheme lets designated healthcare professionals routinely prescribe a specific medicine or class of medicines for a group of patients without needing case-by-case approvals, similar to giving a trusted chef a standing recipe rather than checking each meal. For investors, it matters because such a scheme can speed patient access, increase predictable demand, and reduce regulatory hurdles for manufacturers, affecting sales and revenue forecasts.
GMP-grade regulatory
"expected to supply GMP-grade finished material into sponsor-led studies"
GMP-grade means a drug substance, ingredient or product was manufactured under Good Manufacturing Practice standards — a set of rules and documented controls that ensure consistent cleanliness, quality and traceability. For investors, GMP-grade items matter because they lower regulatory and safety risk, make products eligible for approval and sale in regulated markets, and reduce the chance of costly recalls or supply disruptions; think of it like food prepared in a certified commercial kitchen rather than a home stove.
treatment-resistant depression medical
"use in patients suffering from treatment-resistant depression under Australia’s Authorised Prescriber Scheme"
A form of major depression that does not improve after a person has tried standard treatments such as common antidepressant medications and therapy; think of it as a stubborn problem that doesn’t respond to the usual fixes. It matters to investors because it represents a large unmet medical need and a higher-risk, higher-reward area for drug developers, with potential for premium pricing, regulatory scrutiny, and durable demand if an effective new therapy is approved.
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.
forward-looking statements regulatory
"This press release contains forward-looking statements within the meaning of applicable securities laws"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
 
 

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 May 2026

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.

 

1


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: May 26, 2026

   

By:

 

/s/ Dane Stevens

   

Name:

 

Dane Stevens

   

Title:

 

Chief Executive Officer, Chief Marketing Officer and Director

 

2

Exhibit 99.1

 

LOGO

Optimi Health Advances Highest-Purity Natural Psilocybin Extract to Date

The 6% naturally derived extract is set to be encapsulated for use in patients suffering from treatment-resistant depression under Australia’s Authorised Prescriber Scheme, where no serious adverse events have been reported as of December 2025

Vancouver, British Columbia - (May 26, 2026) - Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) (the “Company” or “Optimi”), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today announced the completion of a production run of naturally derived psilocybin extract measuring approximately 6% psilocybin content, representing the highest-purity botanical psilocybin extract produced by the Company to date.

The milestone reflects sustained gains across Optimi’s cultivation program. Drawing on a proprietary library of more than 200 distinct mushroom genetics maintained at the Company’s facilities, Optimi has selectively advanced cultivars demonstrating increasingly elevated psilocybin content. Those cultivation improvements, combined with refinements to the Company’s extraction process, have produced a botanical extract substantially more concentrated than prior production cycles while maintaining its naturally derived profile.

A portion of the completed extract has been earmarked to support upcoming clinical research programs in Europe, where Optimi is expected to supply GMP-grade finished material into sponsor-led studies. Consistent with the Company’s role as a regulated manufacturer rather than a drug-development sponsor, Optimi’s contribution is the supply of psilocybin-containing finished drug products.

Remaining biomass from the psilocybin production cycle will be retained at Optimi’s facilities for ongoing product development, formulation refinement, and future regulated supply initiatives as international access pathways continue to expand.

The milestone also reinforces Optimi’s commercial supply in Australia, where the Company’s naturally derived 5 mg psilocybin capsules are being prescribed for treatment-resistant depression (“TRD”) under the Therapeutic Goods Administration’s Authorised Prescriber Scheme. The higher-purity extract strengthens the material base supporting that supply. Optimi remains among a small number of commercial-stage companies worldwide whose psilocybin drug products are reaching patients through reimbursed treatment pathways, with eligible Australian patients accessing psilocybin-assisted therapy for TRD supported by established reimbursement initiatives.

Aggregated data published in connection with Australia’s Authorised Prescriber Scheme, under which Optimi has supplied psilocybin finished products since September 2025, indicate that no serious adverse events have been reported among patients treated with psilocybin under the Scheme as of December 2025.

“Higher purity from naturally derived material is a manufacturing achievement,” said Dane Stevens, CEO and Co-Founder of Optimi Health. “We have spent years building a cultivation and extraction platform that gets stronger with every cycle. Reaching 6% psilocybin while maintaining the botanical footprint at scale is exactly the kind of progress we strive for. It strengthens supply for Australian patients, supports clinical research opportunities, and expands the development potential of infrastructure we own and operate.”


LOGO

 

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.

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 within the meaning of applicable securities laws. Forward-looking statements are based on several 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. Accordingly, there are or will be important factors that may cause actual results to differ from expected


LOGO

 

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 US Securities and Exchange Commission that we make from time to time which are available at www.sec.gov or 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.

FAQ

What did Optimi Health Corp. (OPTHF) announce in this 6-K filing?

Optimi Health announced it completed a production run of naturally derived psilocybin extract with approximately 6% psilocybin content. This is the company’s highest-purity botanical psilocybin extract to date and supports both clinical research and commercial treatment programs.

How pure is Optimi Health’s new psilocybin extract and why is it important?

The new extract contains approximately 6% psilocybin, the highest botanical purity Optimi has achieved. Higher concentration means more potent material from the same biomass, which can improve manufacturing efficiency and support broader clinical and therapeutic use in regulated settings.

How will Optimi Health’s 6% psilocybin extract be used in patients?

The 6% extract is expected to be encapsulated for patients with treatment-resistant depression under Australia’s Authorised Prescriber Scheme. It also underpins Optimi’s naturally derived 5 mg psilocybin capsules already prescribed in Australia through regulated and, in some cases, reimbursed treatment pathways.

What role does Optimi Health play in European clinical research programs?

Optimi plans to supply GMP-grade psilocybin finished drug products for sponsor-led clinical studies in Europe. The company focuses on manufacturing and distributing regulated psychedelic products, rather than running the trials itself, providing standardized material for mental health research programs.

What safety data are noted about psilocybin use in Australia’s Authorised Prescriber Scheme?

Aggregated data from Australia’s Authorised Prescriber Scheme indicate that no serious adverse events were reported among patients treated with psilocybin under the Scheme as of December 2025. Optimi has supplied psilocybin finished products into this program since September 2025.

What products does Optimi Health (OPTHF) currently manufacture and supply?

Optimi manufactures GMP-grade psychedelic drug products, including validated MDMA and botanical psilocybin, at facilities in British Columbia. It supplies active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, including Australia’s Authorised Prescriber Scheme and Canada’s Special Access Program.

Filing Exhibits & Attachments

1 document