Relmada Therapeutics(RLMD)2024-05-10 11:13Financial Data and Key Metrics - Net loss for Q1 2024 was $21.8 million ($0.72 per share), compared to $26.3 million ($0.87 per share) in Q1 2023 [23] - Cash, cash equivalents, and short-term investments stood at $83.6 million as of March 31, 2024, down from $96.3 million at the end of 2023 [23] - Cash used in operations for Q1 2024 was $13 million [23] - R&D expenses decreased by $2.6 million to $13.3 million in Q1 2024 compared to Q1 2023 [61] - G&A expenses decreased by $2.6 million to $9.7 million in Q1 2024 compared to Q1 2023 [38] Business Line Data and Key Metrics - The company is advancing its Phase 3 program for REL-1017 as an adjunctive treatment for Major Depressive Disorder (MDD) [17][34] - Reliance II (Study 302) is expected to complete enrollment of 300 patients with top-line data anticipated in H2 2024 [18] - Relight (Study 304) is also enrolling approximately 300 patients, with the primary endpoint being the change in MADRS total score from baseline to day 28 [34] - The company is initiating a Phase 1 trial for its modified release psilocybin formulation in obese patients in H1 2024, with data expected in H1 2025 [1][36] Market Data and Key Metrics - The company operates in a niche space with lower competition, particularly in adjunctive treatment for depression [5][52] - Competition exists in the broader psychedelic space, particularly with psilocybin trials for depression, PTSD, and MDD, but the company's focus on specific indications reduces direct competition [5][52] Company Strategy and Industry Competition - The company has implemented revisions to its screening and enrollment processes to improve patient quality and reduce placebo response, increasing the screen failure rate to 80% compared to 50% in previous trials [19][33] - The company is leveraging its close relationships with clinical sites to drive trial awareness and enrollment [33] - The company is confident in its financial position, with cash on hand expected to fund operations into 2025 [21][23] Management Commentary on Operating Environment and Future Outlook - Management emphasized the importance of patient selection and quality control in clinical trials, with ongoing monitoring of blinded data to ensure consistency [40][41][65] - The company is optimistic about the potential of its REL-1017 program and the novel psilocybin derivative program, with key milestones expected over the next 12-18 months [36][82] - Management highlighted the safety and tolerability of REL-1017, with no significant safety concerns reported [46] Other Important Information - The company has completed preclinical manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing, with a focus on completing the remaining Phase 3 studies [35] - The company is exploring the metabolic benefits of low-dose psilocybin, with preclinical data showing potential improvements in lipids and glucose levels [20] Q&A Session Summary Question: Monitoring of blinded data in Reliance and Relight trials - Management explained that blinded data is used to monitor consistency and quality, with a focus on identifying inconsistencies in patient responses (e.g., zigzag patterns in MADRS scores) [40][41][63] - Sites with inconsistent data may be closed or paused from enrollment to maintain trial integrity [68][69] Question: Interim analysis and DSMB role - No interim analysis is planned for Reliance II, but the DSMB will review data close to the end of the trial to assess sample size adequacy and monitor safety [45][46] Question: Competition and site selection - The company faces limited competition in adjunctive depression trials, with site selection being an ongoing process to ensure quality and avoid over-enrollment [52][53][73] Question: Phase 1 psilocybin trial design - The Phase 1 trial will involve a single ascending dose of modified release psilocybin in obese healthy volunteers, with a focus on pharmacokinetic data [54][84] Question: Screening failure rates - The screening failure rate for Reliance II is approximately 80%, driven by stricter inclusion criteria and the requirement for medical and pharmacy records [19][77][88] - Management is working to optimize enrollment rates without compromising trial quality [86]