Optimi Health (OPTI) H.C. Wainwright 28th Annual Global Investment Conference summary

Commercial operations and product portfolio

• Currently commercial, shipping psilocybin and MDMA to Australia and Canada, with ibogaine in development and expected to be ready by year-end.

• Vertically integrated manufacturing facility in British Columbia produces naturally extracted psilocybin and synthetic MDMA capsules for clinical and commercial use.

• Products are supplied to 26 clinics in Australia, aiming for 100 clinics by end of 2027, and are used for treatment-resistant depression and PTSD.

• Insurance reimbursement for treatments is available in Australia, including coverage by Medibank and government support for veterans.

• Expansion into new markets is planned as global regulatory frameworks evolve, with a focus on Canada, the U.S., and Europe.

Regulatory landscape and market dynamics

• Australia serves as a case study for successful commercialization and regulatory acceptance of psychedelics, with zero serious adverse effects reported.

• Canada is advancing with Bill C-286 and other initiatives, potentially moving faster than the U.S. in rescheduling psychedelics.

• U.S. regulatory momentum is increasing, with FDA hearings and executive orders potentially leading to rescheduling of psilocybin and MDMA to Schedule III.

• The company holds an FDA site license and is prepared to enter the U.S. market upon federal approval.

• Global inquiries and interest in ibogaine have surged following recent U.S. policy announcements.

Strategic positioning and financial highlights

• Differentiated by a regulatory-first approach and focus on manufacturing, enabling commercial sales outside clinical trials.

• Management team includes experienced founders and industry leaders, with significant investment from founders and notable backers.

• Recent $15 million offering in May, with $9.2 million net proceeds and total capital raised at $30 million, mostly from founders and insiders.

• Positioned as the only NASDAQ-listed company with natural psilocybin in-market, competing directly with synthetic-focused peers.

• Anticipates significant revenue growth as more clinics and countries adopt regulated psychedelic therapies.