Relmada Therapeutics(RLMD)2024-11-10 14:39Financial Data and Key Metrics Changes - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of approximately 96.3 million as of December 31, 2023 [12] - Cash used in operations in Q3 2024 was 11.6 million for the same period in 2023 [12] - The net loss for Q3 2024 was 0.72 per share, compared to a net loss of 0.73 per share in Q3 2023 [15] Business Line Data and Key Metrics Changes - Total research and development expense was approximately 10.5 million in the same period of 2023, primarily due to ramp-up expenses related to studies 302 and 304 [13] - Total general and administrative expense for Q3 2024 was approximately 12.2 million in Q3 2023, driven by a reduction in stock-based compensation [14] Market Data and Key Metrics Changes - Approximately 10 million people were treated for a major depressive episode in the last year in the U.S., with 40% of these patients requiring combination therapy [5] Company Strategy and Development Direction - The company's primary focus is on advancing the development of new treatments for CNS disorders, particularly major depressive disorder (MDD) [4] - The company aims to complete the Phase 3 program and the NDA package for REL-1017, with an interim analysis expected by year-end 2024 [5][16] - The clinical program for REL-1017 includes two studies, Reliance II and Relight, designed to evaluate the drug in patients with clinical depression [6] Management's Comments on Operating Environment and Future Outlook - Management believes the interim analysis for the Reliance 2 Phase 3 study could be an important derisking event for the study and the REL-1017 program [5] - The company plans to begin the Phase 2a study for the psilocybin-based metabolic disease program in 2025 [10] Other Important Information - The company expects its current cash position to support operations through key near-term milestones into 2025 [12] Q&A Session Summary Question: What can be expected in the interim release? - Management indicated that the details will depend on the outcome and will provide as much information as possible [16] Question: Clarification on the futility threshold? - The futility threshold is set at approximately 2 points, which is the delta between drug and placebo [18] Question: Will additional patient data be available in the interim readout? - Management confirmed that only the three potential outcomes will be shared, maintaining data integrity [21] Question: If no changes are recommended, what will be the enrollment strategy? - The planned number for enrollment is between 300 and 340, with a slight increase to account for dropouts [23] Question: Confirmation on alpha penalty for interim analysis? - Management confirmed there is no alpha penalty as the interim analysis does not involve an early stop [24] Question: Update on screen failure rates in Reliance II? - The dropout rate is in the mid-single digits, lower than previous trials, indicating good patient compliance [24]