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Cybin (CYBN) investor relations material

Cybin TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary17 Sep, 2025

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.

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Q2 202611 Nov, 2025
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Frequently asked questions

Cybin Inc. is a clinical-stage biopharmaceutical company dedicated to developing psychedelic-based therapeutics. The company focuses on creating treatments for mental health conditions through innovative drug discovery platforms, drug delivery systems, and formulation approaches. Cybin is developing a range of proprietary psychedelic molecules, including CYB003, a deuterated psilocybin analog for major depressive disorder, and CYB004, a deuterated DMT molecule for generalized anxiety disorder. These efforts are part of Cybin's broader mission to address unmet needs in mental healthcare with novel therapeutic options. The company is headquartered in Toronto, Canada, and its shares are listed on the NYSE.

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