Cybin (CYBN) investor relations material

Clinical program updates

• CYB003, a deuterated psilocybin, is in phase 3 development for adjunctive major depressive disorder, with a more stable formulation and robust intellectual property protection, including over 100 granted patents and earliest expiry in 2042.

• The Paradigm phase 3 program includes two pivotal studies, Approach (two-arm, 16mg vs placebo) and Embrace (three-arm, 8mg, 16mg, placebo), enrolling a total of 550 patients, with a long-term extension (Extend) for durability assessment.

• Approach has begun enrollment at 45 US sites, with top-line data expected before the end of 2026; Embrace is set to start imminently, aiming for NDA filing by end of 2027.

• Study designs were endorsed by the FDA, with measures to maintain blinding, including remote blinded raters and expectation management; primary endpoint is MADRS, assessed by independent raters.

• No retreatment in the main studies, but the Extend phase allows for additional dosing based on relapse or non-response, providing key data on durability and long-term safety.

Differentiation and commercial strategy

• CYB003 aims to differentiate through potential for long-lasting efficacy (up to 12 months) with infrequent dosing, compared to more frequent treatments like Spravato.

• Commercial strategy targets interventional psychiatry centers, leveraging existing infrastructure and a partnership with Osmind to optimize patient journey, workflows, and reimbursement.

• Ideal patients are those with inadequate response to SSRIs/SNRIs, seeking alternatives after first- or later-line treatment failure.

• CYB003 is designed for in-clinic, day treatment, fitting within an eight-hour clinic shift and requiring minimal additional resources.

Pipeline and future outlook

• CYB004, a deuterated DMT, is in phase 2 for generalized anxiety disorder, targeting a large unmet need with a two-arm study (2mg vs 20mg, IM), primary endpoint HAM-A at six weeks, and top-line data expected Q1 2026.

• The phase 2 study will inform phase 3 design, focusing on dose response, patient selection, and within-subject improvement.

• DSMBs review safety data quarterly across trials.