Financial Data and Key Metrics Changes - Cash-based operating expenses for Q2 2026 totaled $28.5 million, up from $18.2 million in the same period last year, indicating a significant increase in operational costs [17] - Net loss for Q2 2026 was $33.7 million, compared to a net loss of $41.9 million in the same period last year, showing an improvement in financial performance [17] - Cash flows used in operating activities were $34.5 million for Q2 2026, compared to $19.1 million in the same period last year, reflecting increased operational spending [17] - The company ended the quarter with cash, cash equivalents, and investments of $83.8 million [17] Business Line Data and Key Metrics Changes - CYB003, a proprietary deuterated psilocin analog, is in phase 3 studies for major depressive disorder, while CYB004, a deuterated dimethyltryptamine program, is in phase 2 for generalized anxiety disorder [5][8] - The phase 3 CYB003 program has received breakthrough therapy designation and has been granted additional clearances to commence a second phase 3 study in new geographies [5] - Enrollment for the phase 2 CYB004 study has been completed, with top-line data expected in the first calendar quarter of 2026 [9] Market Data and Key Metrics Changes - The phase 3 study for CYB003 targets approximately 330 participants across about 60 clinical sites globally, indicating a broad market reach [8] - The design of the studies aims to reflect real-world clinical populations, allowing for concomitant antidepressants or anxiolytics [9] Company Strategy and Development Direction - The company is focused on patient-centered care, rigorous science, and clear communication, with an emphasis on operational efficiency and scalability in clinical settings [3][4] - The capital plan is aligned with advancing programs towards major data readouts, following a recent financing of $175 million [4][14] - The strategy includes making therapies practical for clinics, with predictable session scheduling and minimal infrastructure requirements [11][12] Management's Comments on Operating Environment and Future Outlook - Management emphasized a conservative regulatory posture and disciplined capital deployment to navigate upcoming data events [20] - The company is preparing for scale with a model built for clinical reality, aiming to deliver clean data on time [20] - The CEO search is active, and the company is focused on maintaining operational stability during the transition [19][20] Other Important Information - The company has strengthened its capital position through a registered direct offering, which provides flexibility to execute its plans [14] - The repayment of $20 million in convertible debt to High Trail was completed, with a 10% prepayment penalty [61] Q&A Session Summary Question: What would give confidence to move forward with CYB004 into phase 3? - Management is looking for directional data and trends in separation between the two arms of the study, with statistical significance being a bonus [24][25] Question: What is the minimum durability threshold needed to compete with Spravato for CYB003? - A minimum of 12 weeks of maintained effects is expected, with hopes for better durability based on phase 2 data showing effects lasting up to a year [30][31] Question: What is the operational status of the Approach trial and site activations? - Enrollment for CYB003 is on track to complete by mid-next year, with top-line data expected by the end of next year [34][35] Question: What engagement has occurred with payers regarding CYB003 and CYB004? - Preliminary market research has begun, but it is still early for detailed payer engagement [38] Question: What criteria were used for selecting clinical trial sites for the Approach trial? - A mix of experienced and less experienced sites were chosen, focusing on those with a proven track record in delivering high-quality data [44][45] Question: What is the status of the preclinical CYB005 program? - Preclinical profiling studies are ongoing, with no specific updates available yet [46] Question: How important is patient compliance with background antidepressant use in the pivotal trial for CYB003? - Patients are required to remain on their background antidepressant medication during the treatment period [69]

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]