Optimi Health (OPTI) investor relations material

Commercial footprint and market access

• Direct-to-clinic natural psilocybin distribution is active in Australia, where access opened for clinical use in 2024; products are supplied to 26 clinics, with expansion to ~100 targeted over the next year.

• Australian patients receive reimbursement for treatment time and the drug; the speaker described the market as a large real-world clinical setting for natural psilocybin.

• Patient cost for the product was cited at CAD 300–CAD 500, depending on dose; the speaker said therapist time is the larger cost and insurance coverage is important for affordability.

• Potential expansion includes discussions with a Czech distributor, U.K. trials using the product, and Swiss medical tourism; broader Canadian access may depend on parliamentary action over the next one to two years.

Pipeline and regulatory outlook

• A phase II natural psilocybin trial and a phase III MDMA trial were acquired; the trials are Canadian and may support U.S. phase III development, potentially entering that stage around 2028 if they progress as planned.

• Ibogaine production was accelerated, with availability targeted by year-end primarily for research; the speaker flagged cardiac risk and described the program as a research-focused offering.

• A Canadian bill proposed in June would shift Special Access Program decisions toward doctors and patients; passage could broaden access, while timing depends on parliamentary progress.

• U.S. rescheduling and an April executive order were described as policy tailwinds, but any change would still require FDA, DEA and related regulatory steps; potential MDMA Schedule III action was speculative.

• Potential U.S. commercial catalysts include Australian clinic expansion, progress in phase II and phase III trials, and possible future MDMA rescheduling; Compass was described as potentially reaching commercialization next year.

Manufacturing and product differentiation

• Production is vertically integrated at a GMP vaccine-level facility in British Columbia, from cultivation and extraction through formulation, quality control, release, export and dispensing.

• A selected cubensis strain was developed through screening hundreds of strains; the speaker described testing as showing consistent results for the natural product.

• Products are supplied for research in markets including the U.S., U.K. and Australia, subject to applicable licensing and regulatory requirements.

• The speaker positioned natural psilocybin as differentiated from synthetic candidates, citing potential price advantages and a distinct product; comparative efficacy was presented as a market argument, not a trial result.