Optimi Health (NASDAQ: OPTH) makes third psilocybin shipment for TRD
Rhea-AI Filing Summary
Optimi Health Corp. reports completing an export of its 5mg psilocybin capsules to Australia, marking the company’s third commercial shipment since launching the product in September 2025. The shipment contained 1,000 capsules that are being prescribed for treatment-resistant depression, a severe form of major depression that has not improved with multiple standard therapies.
Australia rescheduled psilocybin to a controlled medicine for treatment-resistant depression effective July 1, 2023, and Optimi is one of a small number of GMP-licensed manufacturers supplying naturally derived psilocybin to that market. Management notes that its psilocybin is being prescribed under the Therapeutic Goods Administration’s Authorized Prescriber Scheme, reimbursed by public and private payers, and that more than 750 clinicians have been trained to deliver the therapy, with no serious adverse events known to the company after more than two years of regulated commercial use.
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Insights
Third psilocybin shipment to Australia reinforces Optimi’s early commercial footing but financial scale is not disclosed.
Optimi Health highlights its third commercial export of 5mg psilocybin capsules to Australia, with 1,000 capsules in this shipment. The product targets treatment-resistant depression under Australia’s Authorized Prescriber Scheme, which allows regulated patient access with reimbursement from public and private payers.
The company positions itself among a small group of GMP-licensed suppliers of naturally derived psilocybin to this market and also manufactures MDMA. Management cites expanding reimbursement coverage and more than 750 trained clinicians, suggesting a growing treatment ecosystem. Actual revenue or margin contribution from these recurring orders is not quantified in the disclosure.
Forward-looking statements emphasize expectations for continued exports, prescribing, reimbursement, and recurring commercial orders. The durability of this opportunity will depend on ongoing regulatory support in Australia, prescriber adoption, and the company’s ability to maintain GMP-compliant production and export authorizations at its Canadian facility.
Key Figures
Key Terms
treatment-resistant depression medical
Authorized Prescriber Scheme regulatory
GMP facility technical
Drug Establishment Licence regulatory
Special Access Program regulatory
forward-looking statements regulatory
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 29, 2026 | By: | /s/ Dane Stevens | ||||
| Name: | Dane Stevens | |||||
| Title: | Chief Executive Officer, Chief Marketing Officer and Director | |||||
Exhibit 99.1
Optimi Health Completes Psilocybin Export to Australia for Patients With Treatment-Resistant Depression
Optimi’s 5mg psilocybin capsules are prescribed in Australia for treatment-resistant depression.
The export marks Optimi’s third commercial shipment since launching the 5mg psilocybin capsules in September 2025.
VANCOUVER, British Columbia, June 29, 2026 (GLOBE NEWSWIRE) - 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 its latest export of 5mg psilocybin finished drug product to Australia, marking its third commercial shipment since the September 2025 launch of its 5mg psilocybin capsules.
The shipment included 1,000 capsules of 5mg psilocybin, which are being prescribed in Australia for treatment-resistant depression (“TRD”), an indication for which regulated patient access is available. TRD refers to major depression that has not responded to multiple standard antidepressant treatments and represents a significant unmet medical need.
“We are proud to be among the few Nasdaq-listed companies commercially supplying psilocybin to patients with treatment-resistant depression outside of clinical trials,” said Dane Stevens, CEO and Co-Founder of Optimi. “Our medicine is produced start to finish in Canada and shipped to pharmacy partners globally, and we are seeing expanding reimbursement coverage from both private and public insurers. We believe Australia is providing an early model for how naturally derived psilocybin can be safely prescribed for TRD in real-world practice, and we are not aware of any serious adverse events reported since inception based on data collected through December 31, 2025.”
Australia became the first country in the world to recognize psilocybin as a medicine, rescheduling it from a prohibited substance to a controlled medicine for the treatment of TRD, effective July 1, 2023. MDMA was rescheduled for the treatment of post-traumatic stress disorder on the same day, and Optimi manufactures both psilocybin and MDMA. Patients have since gained broader access under an updated Authorized Prescriber framework that expanded therapist eligibility and treatment settings, as detailed in the Company’s news release dated May 29, 2026.
Under the Therapeutic Goods Administration’s Authorized Prescriber Scheme, Optimi’s psilocybin is being prescribed to patients in Australia and reimbursed by both public and private payers, including the Department of Veterans’ Affairs, the National Disability Insurance Scheme, WorkCover, and Medibank. More than 750 clinicians have been trained to deliver the therapy, and the Company is not aware of any serious adverse events that have been reported under the scheme after more than two years of regulated commercial use.
The exported capsules were produced start to finish in-house at Optimi’s wholly owned GMP facility in Princeton, British Columbia, Canada, under its Health Canada Drug Establishment Licence, and shipped under export authorization issued by Health Canada. Optimi is among a small number of GMP-licensed manufacturers supplying naturally derived psilocybin to the Australian market, where recurring orders contribute to commercial revenue for the Company.
Optimi supplies finished psilocybin and MDMA drug products to regulated markets internationally, in support of both patient access and clinical research. Inquiries regarding product for special access programs and clinical trial supply 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 continued and future exports and supply of the Company’s psilocybin products to Australia, continued prescribing, patient access and reimbursement in the Australian market, recurring commercial orders and revenue, 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 are often identified by words such as “expects,” “anticipates,” “believes,” “intends,” “plans,” “estimates,” “may,” “will,” “would,” “could,” or similar expressions. Forward-looking statements 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 or 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.