Cybin (NYSEAM:CYBN) FY Conference Transcript

Summary of Cybin (NYSEAM:CYBN) FY Conference Call - November 10, 2025 Company Overview - Company: Cybin - Industry: Biotechnology, specifically focusing on psychedelic treatments for psychiatric conditions Key Clinical Programs - Programs: Two clinical-stage programs targeting major depressive disorder (MDD) and generalized anxiety disorder (GAD) using psychedelics - Patient Population: Approximately 20 million patients in the U.S. suffer from anxiety and depression each [2][4] Core Products - CYB003: Deuterated psilocin, currently in Phase 3 for MDD - FDA Designation: Granted Breakthrough Therapy Designation - Study Design: Enrolling 550 patients across two pivotal studies (Approach and Embracing) with a long-term extension study [4][10] - Dosing: Two doses three weeks apart; robust effects observed with lower doses compared to traditional psilocybin [6][10] - Efficacy: Phase 2 results showed a 13- to 14-point separation from placebo; 71% remission at 12 months after two doses [9][10] - CYB004: Deuterated DMT, currently in Phase 2 for GAD - Study Completion: Enrollment completed as of September; results expected in Q1 next year [5][41] - Dosing: Two intramuscular doses of 20 mg for the active group, with a control group receiving 2 mg [41] Clinical Insights - Psychedelic Mechanism: Psychedelics are believed to offer rapid and long-lasting relief for psychiatric conditions [2][3] - Patient Experience: Patients experience rapid onset of effects (within 15 minutes) with a duration of 4-6 hours [6][7] - Safety Profile: Favorable safety profile observed in Phase 2; no serious adverse events reported [26][27] Study Design and Regulatory Considerations - Phase 3 Studies: Both studies include placebo controls; one study also includes a mid-dose arm to address functional unblinding [14][15] - Regulatory Strategy: Plans to submit data from both Phase 3 studies and the long-term extension for FDA approval [21][25] Financial Position - Capitalization: As of Q2, Cybin had $119 million; recently completed financing of $175 million, ensuring funding for key readouts in the upcoming year [49] Additional Considerations - Adjunctive Treatment Approach: Targeting MDD as an adjunctive treatment allows for a broader patient population and reduces barriers to adoption [32][33] - Future Directions: Data from CYB004 may inform potential applications in depression, although currently focused on anxiety [45] This summary encapsulates the key points discussed during the conference call, highlighting Cybin's innovative approach to treating psychiatric disorders through psychedelic compounds and its strategic positioning within the biotechnology industry.