Cybin (NYSEAM:CYBN) FY Conference Transcript

Summary of Cybin Inc. Conference Call Company Overview - Company: Cybin Inc. - Lead Product: CYB003, a deuterated psilocybin compound in clinical development for adjunctive treatment of major depressive disorder (MDD) [1][2] Key Points Product Advantages - Deuterated Psilocybin: CYB003 offers advantages over naturally occurring psilocybin by removing the metabolic step, leading to reduced variability and a more stable formulation [2][3] - Intellectual Property: Cybin holds over 100 granted patents and more than 250 pending patents related to CYB003, establishing a strong intellectual property position [4][5] Clinical Program - Paradigm Program: The Phase 3 program includes pivotal studies named Approach and Embrace, with a total enrollment of 550 patients across both studies [7][9] - Study Designs: - Approach: Two-arm study comparing 16 mg of CYB003 with placebo, with a primary endpoint at six weeks and a secondary endpoint at 12 weeks [8][9] - Embrace: Three-arm study including an inert placebo, an intermediate dose of 8 mg, and the active dose of 16 mg, with a total of 330 patients [9][13] - Enrollment Status: Enrollment for Approach is underway in the US, with approximately 45 sites involved, aiming for top-line data by the end of 2026 [9][12] Efficacy and Safety - Expected Outcomes: Previous Phase 2 data showed a differentiation of about 14 points on the MADRS scale from placebo. Even a reduced effect in Phase 3 would still be significant compared to historical data for SSRIs [28][29] - Durability of Effect: The long-term extension study aims to demonstrate the durability of the treatment effects, with expectations of data on how long patients remain in response or remission [32][29] Regulatory and Design Considerations - FDA Guidance: The study designs have been endorsed by the FDA, which allows for regular discussions regarding the trial's progress and design [18][19] - Blinding Measures: The studies will employ a randomized double-blind approach, with measures in place to reduce functional unblinding [19][23] Commercial Strategy - Market Positioning: CYB003 is positioned as a treatment for patients with inadequate responses to traditional SSRIs and SNRIs, with a focus on interventional psychiatry centers [41][36] - Partnerships: Cybin has partnered with Osmind to better understand patient experiences and clinical workflows relevant to commercialization [38][39] Future Developments - CYB004 for GAD: Cybin is also developing CYB004, a deuterated DMT for generalized anxiety disorder (GAD), with a Phase 2 study expected to deliver top-line data in Q1 2026 [42][45] - Study Design for GAD: The Phase 2 study will compare a low-dose control with an active dose, focusing on the HAM-A scale for primary endpoints [46][47] Additional Insights - Patient Experience: The treatment is designed to be administered in a day treatment setting, allowing for a streamlined patient experience [40][36] - Market Need: There is a significant market opportunity for GAD treatments, with a global prevalence of approximately 300 million patients [42][43]