Relmada Therapeutics(RLMD)2024-08-09 10:25Financial Data and Key Metrics Changes - Research and development expenses for Q2 2024 were approximately 3 million from 8.1 million, down from 17.8 million, or 25.3 million, or 70.4 million, down from $96.3 million at the end of 2023 [13] Business Line Data and Key Metrics Changes - The company is focused on the Phase 3 program for REL-1017, which is designed as a potential adjunctive treatment for major depressive disorder (MDD) [4][6] - Two pivotal Phase 3 studies, Reliance II and Relight, are currently enrolling up to 340 subjects each, with a focus on patients with documented clinical depression [6][8] - The ongoing studies are designed to assess the impact of REL-1017 on the MADRS score, with a target delta of 2 to 2.5 points at day 28 [6] Market Data and Key Metrics Changes - The company is targeting the central nervous system disorder market, specifically focusing on major depressive disorder and metabolic diseases [4][10] - REL-P11, a proprietary psilocybin program, is in development for metabolic diseases, with plans to initiate a Phase 1 study shortly [10][11] Company Strategy and Development Direction - Completing the Phase 3 program for REL-1017 is the company's top priority, with plans for an interim analysis by year-end 2024 [5][14] - The company aims to utilize its current cash position to support operations into 2025, focusing on key clinical milestones [13][14] - The decision to conduct the psilocybin study in Canada is due to favorable regulatory conditions and infrastructure for Phase 1 trials [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical program's progress and the potential for REL-1017 to meet important milestones [3][4] - The company is taking a cautious approach to patient enrollment and study design to mitigate risks associated with clinical trials [7][8] - Management emphasized the importance of the upcoming interim analysis as a tool to assess the study's viability and make informed decisions moving forward [9][24] Other Important Information - The company is observing an approximately 80% screen failure rate in the ongoing studies, indicating stringent enrollment criteria [8] - The interim analysis will include a futility analysis and may lead to adjustments in sample size if necessary [9][25] Q&A Session Summary Question: Can you remind us the baseline measures for the ongoing Reliance II study? - The baseline MADRS average for the patient population is in the mid-30s, around 33-34 for all studies [15] Question: Will the sample size re-estimation impact the timeline for the second trial? - It may impact the timeline, but not materially; the company is confident in finishing enrollment in about six months [16][19] Question: Why did the estimated patient enrollment number change to 340? - The number is a guideline for the FDA and does not mean the company will necessarily enroll 340 patients [21][22] Question: Is there a statistical penalty with the futility option? - There is no alpha penalty in the futility analysis as it does not involve early stopping for efficacy [26] Question: What would be the threshold for futility? - The threshold has not been finalized, but it will be set close to a non-clinically meaningful threshold [27] Question: What proportion of the study will be completed ahead of the interim analysis? - The interim analysis is expected to take place when approximately 70-80% of the trial is completed, likely by the end of the year [30][31] Question: Why is the psilocybin study being conducted in Canada? - Canada has a favorable regulatory environment and good facilities for Phase 1 trials, making it easier than in the U.S. [32]