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.

Core Insights - HOPE Therapeutics, Inc. has acquired a strategic interest in Cohen and Associates, LLC, integrating it into the HOPE Network, with Dr. Rebecca Cohen appointed as Medical Director overseeing care standards in Florida [1][9] Company Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focusing on building a network of interventional psychiatry clinics offering treatments such as ketamine and Transcranial Magnetic Stimulation (TMS) for patients with suicidal depression and related disorders [7] - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal depression and PTSD, with products like NRX-100 and NRX-101 [6] Leadership and Expertise - Dr. Rebecca Cohen is a recognized expert in TMS and has a strong academic background, having founded her practice in 2014 as one of the first dedicated interventional psychiatry practices in the U.S. [3][9] - The leadership team at HOPE, including Dr. Cohen and Stephen Durand, RN, aims to advance interventional psychiatry and expand treatment options for patients [4][5] Strategic Goals - The acquisition of Cohen, LLC is expected to enhance HOPE Therapeutics' revenue and EBITDA, with immediate expansion plans in Western Florida and Palm Beach [9]