Optimi Health Corp. (OPTH) announced it established Optimi Australia Pty Ltd as a wholly owned subsidiary for distribution and business development in Australia, and appointed Adrian Jones as Director of Australian Operations. The subsidiary will manage sales, distribution and prescriber relationships, selling 5 mg naturally derived psilocybin capsules and 40 mg and 60 mg MDMA capsules to clinics and pharmacies under Australia's Authorised Prescriber Scheme.
Optimi says the products are manufactured at its Health Canada-licensed GMP facility in Princeton, British Columbia. Jones joins after more than 15 years at Bristol Myers Squibb, most recently leading sales and marketing for its Australian oncology and cardiovascular portfolios.
Optimi Health Corp. completed production of its latest batch of finished MDMA capsules at its GMP facility in Princeton, British Columbia. The company expects the batch to supply its proposed Phase 3 PTSD trial in Canada, a clinical trial in Israel with the Multidisciplinary Association for Psychedelic Studies (MAPS), and a commercial export to Australia planned before the end of 2026.
The proposed Canadian study is expected to begin in 2027 and enroll up to 100 veterans and current or former frontline workers. Participants are expected to receive two supervised MDMA-assisted therapy sessions combining MDMA and psychotherapy, spaced several weeks apart, with follow-up evaluations. The primary efficacy endpoint is change in the Clinician-Administered PTSD Scale (CAPS-5). Optimi states that MDMA safety and efficacy remain under investigation in Canada and its products have not received Health Canada market authorization.
Optimi Health Corp. (OPTH) announced it will participate in the ThinkEquity Conference on October 15, 2026, at the Mandarin Oriental Hotel in New York City. Management will present a corporate overview at 4:00 p.m. Eastern time.
Optimi Health Corp. is the issuer whose common stock is covered by YA II PN, Ltd.’s amended ownership report. YA II reports beneficial ownership of 173,000 shares, or 3.0% of the class, with shared voting and dispositive power over 173,000 shares and no sole voting or dispositive power. The disclosure says YA Global Investments II (U.S.), LP, Yorkville Advisors Global, LP, Yorkville Advisors Global II, LLC, YAII GP, LP, YAII GP II, LLC, and Mark Angelo may be deemed affiliates and beneficial owners of the same shares. Yorkville Advisors Global is the investment manager to YA II, and Mark Angelo makes investment decisions on its behalf. David Gonzalez, General Counsel, and Mark Angelo signed the report.
Optimi Health Corp. (OPTH) appointed Melanie Pump to its Board of Directors on September 29, 2026. Pump is Chief Financial Officer of Qu Data Centres and has more than 25 years of experience across technology, digital infrastructure, software, fintech and emerging growth companies. She also serves on the board of Mobio Technologies Inc. and previously served as a director of BTCS Inc.
Leah Hodges resigned as Corporate Secretary, and Chief Executive Officer Dane Stevens was appointed to fill the role.
Optimi Health Corp. (OPTH) completed and quality-released a batch of 5mg naturally derived psilocybin capsules, manufactured at its Princeton, British Columbia facility under a Health Canada Drug Establishment Licence. The batch will supply a Health Canada-authorized, multisite, open-label Phase 2 trial evaluating psilocybin-assisted therapy for major depressive disorder (MDD) and licensed Australian clinics prescribing the capsules for treatment-resistant depression (TRD) under the Therapeutic Goods Administration’s Authorised Prescriber Scheme. Optimi says the trial and commercial products are the same formulation from the same batch. The trial may include up to 200 participants, with patient dosing expected to be completed by the end of 2027. Optimi states that safety and efficacy for MDD remain under investigation and none of its psilocybin drug products has received Health Canada market authorization.
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.
Optimi Health Corp. (OPTH) reported that it plans to initiate a Health Canada-authorized Phase 3 clinical trial of MDMA-assisted therapy for post-traumatic stress disorder (PTSD), with the trial expected to begin in 2027. The study is intended to enroll up to 100 veterans and frontline workers at multiple Canadian sites and will use Optimi’s synthetic MDMA HCl in two supervised MDMA-plus-psychotherapy sessions per participant, spaced several weeks apart. The primary efficacy endpoint will be change in the CAPS-5 clinician-rated PTSD severity score. The company notes that the safety and efficacy of MDMA-assisted therapy for PTSD remain under investigation and that none of its MDMA products has market authorization from Health Canada, though its MDMA is being prescribed in Australia under that country’s Authorized Prescriber Scheme.
Optimi Health Corp. (OPTH) plans to launch a multisite Phase 2 clinical trial of psilocybin-assisted therapy for major depressive disorder (MDD) in the first half of 2027, with dosing expected to be completed by the end of 2027. The Health Canada–authorized study will enroll up to 200 participants across multiple Canadian sites and test the safety and efficacy of a single supervised dose of naturally derived psilocybin. The primary efficacy endpoint is change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline. Optimi will supply its own GMP-manufactured psilocybin, retain exclusive ownership of trial results, and states it can comfortably fund the trial with current cash on hand.
Optimi Health Corp. (OPTH), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, reported that it will participate in the H.C. Wainwright 28th Annual Global Investment Conference in New York, held September 14-16, 2026. A company presentation will be available on demand starting September 11, 2026, at 7:00 a.m. ET, and management plans to be available for one-on-one meetings throughout the conference. Optimi manufactures and distributes GMP-grade MDMA and botanical psilocybin drug products from its facilities in British Columbia, supplying active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally.