Optimi Health Corp. (NASDAQ: $OPTH; also CSE: $OPTI) is a small-cap Canadian pharmaceutical manufacturer focused on GMP-grade psychedelic drug products
—primarily naturally derived psilocybin and MDMA capsules.
It operates a Health Canada Drug Establishment–licensed cGMP facility in Princeton, British Columbia, and positions itself as an end-to-end supplier (cultivation/processing through finished capsules) for authorized clinics, research trials, and limited commercial channels. CEO is Dane Stevens. Headquarters listed as Squamish/Princeton, BC. Founded 2020. Very small team (often cited around 9–11 employees).
earnings.
Business
• Commercial: 5 mg natural psilocybin capsules prescribed in Australia for treatment-resistant depression (TRD) under the TGA Authorised Prescriber Scheme, with some payer coverage (DVA, NDIS, etc.). Multiple small export shipments since a September 2025 launch.
• Clinical supply: Psilocybin and MDMA for Health Canada Special Access Program and authorized trials in Canada, plus exports (e.g., UK Phase 2 support).
• Pipeline / trials announced:
◦ Phase 2 open-label psilocybin-assisted therapy for major depressive disorder (MDD): up to 200 participants, multisite Canada, single supervised dose; dosing targeted to complete by end of 2027.
◦ Phase 3 MDMA-assisted therapy for PTSD: up to 100 veterans and frontline workers; Health Canada–authorized; expected to start in 2027.
• Also developing ibogaine finished product after securing supply (U.S. policy interest cited as a tailwind).
• Functional mushroom / nutraceutical side exists but is secondary to the controlled-substance manufacturing story.
No U.S. FDA-approved products yet; U.S. path is described as waiting on federal rescheduling.
Recent news (with links)
Sep 23, 2026 — Completed and quality-released an in-house cGMP batch of 5 mg natural psilocybin capsules. Same batch supplies the planned Canadian Phase 2 MDD trial and Australian commercial TRD clinics.
https://www.globenewswire.com/news-release/2026/09/23/3367523/0/en/optimi-health-completes-psilocybin-production-for-health-canada-approved-phase-2-mdd-trial-and-commercial-trd-supply.html
IR listing: https://ir.optimi.net/press-releases
Sep 22, 2026 — Appointed Michael Blough, Ph.D., as Chief Clinical Development Officer to oversee the Phase 2 psilocybin MDD and Phase 3 MDMA PTSD programs.
https://www.globenewswire.com/search/organization/optimi%20health%20corp (Sep 22 release)
https://www.stocktitan.net/news/OPTH/
Company IR / press list: https://ir.optimi.net/press-releases
Corporate site: https://www.optimi.net/
Investor site: https://ir.optimihealth.ca/
Not investment advice. This is a speculative micro-cap; confirm latest quote, filings, and 6-Ks on EDGAR or the company IR page before acting.