Cybin (NYSEAM:CYBN) FY Conference Transcript

Summary of Cybin Inc. FY Conference Call (September 08, 2025) Company Overview - Company: Cybin Inc. (NYSEAM:CYBN) - Industry: Neuropsychiatry, focusing on next-generation psychedelics and neuromodulators for mental health - Key Products: - CYB003: Deuterated psilocin analog for major depressive disorder (MDD) - CYB004: Deuterated DMT compound for generalized anxiety disorder (GAD) [1][2] Core Points and Arguments Treatment Landscape - Traditional treatments for mood disorders like depression and anxiety often involve chronic daily dosing with SSRIs and SNRIs, with two-thirds of patients not responding initially [2] - Side effects from current treatments can be significant, including sexual dysfunction and weight gain [2] - Interventional psychiatry has emerged, utilizing treatments like TMS and S-Ketamine, but access remains limited due to administrative burdens [3][4] Cybin's Approach - Cybin aims to evolve the interventional paradigm by offering treatments that require significantly less frequent dosing, potentially only two doses per year [4] - CYB003 has received FDA Breakthrough Therapy Designation and is currently in a phase 3 program (APPROACH) for MDD, with a second study (EMBRACE) expected to start soon [4][5] Clinical Data - In a phase 2 trial for CYB003, a 100% response rate and a 71% remission rate at 12 months were reported, with an average drop of 23 points on the MADRS scale [10][11] - The phase 3 program (PARADIGM) includes 550 patients across two studies, with a long-term extension to assess durability and redosing profiles [13][14][18] Mechanism of Action - CYB003 acts as an agonist at various serotonin receptors, hypothesized to induce a window of plasticity in the brain, allowing for rapid reorganization of maladaptive thinking patterns [9] - CYB004 is delivered via intramuscular injection, with a shorter duration of effect, aimed at treating moderate to severe GAD [26] Market Opportunity - The U.S. market for SSRIs and SNRIs is substantial, with approximately 15% of the population on these medications [36] - Spravato, a similar treatment, has generated $1.6 billion in sales, indicating a significant market potential for Cybin's products [36] Future Directions - Cybin is exploring potential expansions for both CYB003 and CYB004 into other mood and behavioral disorders, including addiction [33][34] - The collaboration with OZMINE, which operates an 800 clinic network, is expected to enhance clinical and commercial readiness for Cybin's treatments [35] Important but Overlooked Content - The long-term extension study (EXTEND) aims to understand the efficacy and durability of treatment effects over time, as well as the redosing profile for patients who may relapse [18][20] - The company anticipates providing top-line data for CYB004 in Q1 of the following year, with expectations for the first phase 3 study (APPROACH) data by the end of the current year [41]