Relmada Therapeutics(RLMD)2023-08-09 01:46Financial Data and Key Metrics - For Q2 2023, the net loss was $25.3 million ($0.84 per share), compared to a net loss of $39.9 million ($1.33 per share) in Q2 2022 [28] - For the six months ended June 30, 2023, the net loss was $51.6 million ($1.72 per share), compared to $79.7 million ($2.73 per share) in the same period of 2022 [29] - Cash, cash equivalents, and short-term investments stood at $118.5 million as of June 30, 2023, down from $148.3 million as of December 31, 2022 [29] - Total R&D expenses for Q2 2023 were $13.7 million, a decrease of $17.2 million compared to $30.9 million in Q2 2022 [60] - Total G&A expenses for Q2 2023 were $12.3 million, a decrease of $2.3 million compared to $14.6 million in Q2 2022 [67] Business Line Data and Key Metrics - The Phase 3 program for REL-1017 in major depressive disorder (MDD) is progressing as planned, with RELIANCE II (Study 302) expected to complete in H1 2024 and Relight (Study 304) in H2 2024 [4][58][65] - Enrollment targets for RELIANCE II and Relight are approximately 300 patients each, with screening and enrollment actively underway [65] - The open-label safety study (Study 310) for REL-1017 has concluded, with data expected to be available in the current quarter [66] Market Data and Key Metrics - The company has a significant presence at upcoming scientific conferences, including the 36th Annual ECNP Congress in October 2023, where multiple posters will be presented [26] Company Strategy and Industry Competition - The company remains focused on developing REL-1017 as an adjunctive treatment for MDD, with critical protocol amendments to reduce placebo response and improve trial efficiency [57][64] - The company believes its drug, if approved, would be a once-daily treatment add-on, aligning with FDA expectations for MDD drug development [49] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the approvability of REL-1017 and the execution of the Phase 3 trials, with sufficient funding to reach data readouts for both RELIANCE II and Relight [53][59][62] - The company has seen an uptick in screening and randomization for RELIANCE II, with positive feedback from investigators on the streamlined protocols [10][33][71] Other Important Information - The company has published human abuse potential data for REL-1017 in the peer-reviewed journal Translational Psychiatry [59] - The company has fulfilled ICH guidelines for drug exposure, with the open-label study providing long-term safety data required for NDA filing [81] Q&A Session Summary Question: Enrollment progress for Study 302 and confidence in completing it by H1 2024 - The company has seen an uptick in screening and randomization, with 50 sites targeted for both Study 302 and 304 [10][69] - Feedback on the streamlined protocols has been positive, with efficient site operations and data entry [12][33] Question: Potential for interim analysis in the trials - An interim analysis is possible, but the company has not disclosed specific details on timing or assessment criteria [73] Question: Impact of FDA CRL for zuranolone on RELIANCE II and Relight - The company does not believe the FDA CRL for zuranolone impacts its development plans, as REL-1017 has a traditional mode of administration and chronic treatment approach [21][79] Question: Primary endpoint measurement for Relight study - The primary endpoint for both RELIANCE II and Relight is the change in MADRS total score from baseline to day 28 [41][58] Question: Data sharing plans for the open-label study - The company plans to share efficacy, safety, and tolerability data from the open-label study, providing a comprehensive picture of patient improvement over 12 months [44][51]