Optimi Health (NASDAQ: OPTH) secures ibogaine supply and starts GMP product work
Rhea-AI Filing Summary
Optimi Health Corp. reported progress on its ibogaine initiative, securing naturally derived ibogaine from two sources in both hydrochloride and freebase forms. The company plans to begin finished drug product development this summer at its GMP facility in British Columbia, initially targeting encapsulated 50mg and 100mg doses.
The update follows an April 2026 U.S. executive order that prioritized ibogaine and other psychedelic therapies for accelerated FDA review and expanded patient access, increasing demand for reliable GMP-grade supply. In Canada, ibogaine is regulated as a prescription drug rather than a controlled substance, which, combined with Optimi’s existing Health Canada licenses, positions the company to manufacture and supply ibogaine for research and regulated access.
Optimi already produces validated MDMA and botanical psilocybin products and supplies active ingredients and finished dosages to international clinical and therapeutic programs, including Australia’s Authorized Prescriber Scheme and Canada’s Special Access Program.
Positive
- None.
Negative
- None.
Insights
Optimi moves into ibogaine, leveraging existing GMP psychedelic platform.
Optimi Health is expanding beyond psilocybin and MDMA by securing ibogaine supply and starting encapsulated product development at its GMP facility. This aligns the company with growing public and state-backed interest in ibogaine research, including a $50 million Texas program.
The regulatory contrast is important: ibogaine is a prescription drug in Canada but a Schedule I substance in the U.S. This makes Canadian GMP production and export for regulated channels a key part of the model. Actual commercial impact will depend on clinical trial demand and access programs adopting ibogaine products.
Investors may focus on how quickly Optimi can complete its in-house development program and secure clinical or special access supply agreements. Subsequent disclosures could clarify manufacturing scale, margins relative to existing MDMA and psilocybin lines, and the breadth of research partnerships using its ibogaine products.
Key Figures
Key Terms
GMP technical
Schedule I substance regulatory
Special Access Program regulatory
Authorized Prescriber Scheme regulatory
forward-looking statements regulatory
FAQ
What did Optimi Health (OPTH) announce about its ibogaine initiative?
How is Optimi Health (OPTH) planning to manufacture ibogaine products?
Why is the regulatory status of ibogaine important for Optimi Health (OPTH)?
How does recent U.S. policy affect Optimi Health’s ibogaine plans?
What other psychedelic products does Optimi Health (OPTH) currently manufacture?
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 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 | |
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 8, 2026 | By: | /s/ Dane Stevens | ||||
| Name: | Dane Stevens | |||||
| Title: | Chief Executive Officer, Chief Marketing Officer and Director | |||||
Exhibit 99.1
Optimi Health Secures Ibogaine Supply and Commences Finished Drug Product Development
Recent US executive order named ibogaine compounds among the psychedelic therapies prioritized for
accelerated FDA review and expanded patient access
Ibogaine is under investigation to treat PTSD, opioid use disorder and traumatic brain injury
VANCOUVER, British Columbia, June 8, 2026 – via IBN – Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) (the “Company” or “Optimi”), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today provided an update on its recently announced Ibogaine Initiative. Optimi has secured naturally derived ibogaine from two sources, in both hydrochloride (HCl) and freebase form. Development work on the finished drug product is anticipated to commence this summer at the Company’s GMP facility in British Columbia, Canada.
“We are seeing a growing number of research institutions interested in ibogaine, and there is real public funding behind it now, including the $50 million program in Texas[1],” said Dane Stevens, CEO and Co-Founder of Optimi. “We are excited to develop and supply this product from Canada, where we have the facility, the licensing, and the experience to make it into standardized pharmaceutical dosages.”
Two dosage sizes, 50mg and 100mg, are planned in encapsulated format. The in-house development program covers standard operating procedures (SOPs) for finished drug encapsulation, dosage strengths, bottling, labeling, and packaging, alongside validation of the Company’s manufacturing and analytical testing methods. The Company will provide an update upon completion of the program.
On April 18, 2026, a U.S. Executive Order named ibogaine compounds among the psychedelic therapies prioritized for accelerated Food and Drug Administration review and expanded patient access, and directed federal funding to match state investments in psychedelic research.[2] This has intensified attention on ibogaine and on the need for a reliable, GMP-grade supply.
In Canada, ibogaine is not a controlled substance under Canada’s Controlled Drugs and Substances Act[3]; rather, it is regulated under the Food and Drugs Act (Canada) and is listed on Health Canada’s Prescription Drug List.[4] In contrast, ibogaine remains a Schedule I substance in the United States. Combined with Optimi’s GMP infrastructure and current Health Canada licensing, this regulatory environment positions Canada, and Optimi specifically, as an advantageous base for the compliant manufacture and supply of ibogaine to support research and regulated access.
Ibogaine is a naturally occurring alkaloid derived from the root bark of the Tabernanthe iboga shrub, native to Central and West Africa. It has been studied for its potential to interrupt opioid withdrawal and craving, and for its effects on substance-use disorders, post-traumatic stress disorder (PTSD), and traumatic brain injury (TBI). A 2024 Stanford-led study of U.S. Special Operations veterans, published in Nature Medicine, reported reductions in PTSD, depression, anxiety, and functional disability in a cohort following a single ibogaine treatment protocol.[5]
Optimi is developing its ibogaine product at the Company’s wholly owned GMP facility, which it also uses to manufacture psilocybin and MDMA. The Company supplies finished drug products and active pharmaceutical ingredients for clinical research and regulated patient access. 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
Notes and Sources
[1] UTHealth Houston. “UTHealth Houston, in collaboration with UTMB Health, awarded $50 million by the state of Texas to lead ibogaine clinical trials.”
[2] The White House. “Accelerating Medical Treatments for Serious Mental Illness.” Presidential Actions, April 18, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/
[3] Government of Canada. Controlled Drugs and Substances Act. Ibogaine is not listed in the schedules to the Act. https://laws-lois.justice.gc.ca/eng/acts/c-38.8/
[4] Health Canada. “Notice-Prescription Drug List (PDL): Multiple additions” (2017). https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notice-prescription-drug-list-multiple-additions-2.html
https://www.uth.edu/news/story/uthealth-houston-in-collaboration-with-utmb-health-awarded-50-million-by-the-state-of-texas-to-lead-ibogaine-clinical-trials
[5] Cherian, K.N., et al. “Magnesium-ibogaine therapy in veterans with traumatic brain injuries.” Nature Medicine (2024). https://www.nature.com/articles/s41591-023-02705-w
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 Company’s development of an ibogaine initiative, ability to supply finished product and the anticipated benefits and uses of ibogaine and the Company’s ibogaine initiative. Forward-looking statements are often identified by words such as “expects,” “anticipates,” “believes,” “intends,” “plans,” “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.
InvestorWire Service Contact:
IBN
Austin, Texas
www.InvestorBrandNetwork.com
512.354.7000 Office
Editor@InvestorBrandNetwork.com