Relmada Therapeutics(RLMD)2025-05-12 21:30Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of approximately 44.9 million as of December 31, 2024 [21] - Cash used in operations for Q1 2025 was 13 million for the same period in 2024 [22] - The net loss for Q1 2025 was 0.58 per share, compared to a net loss of 0.72 per share, for Q1 2024 [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2025 totaled 13.3 million in Q1 2024, primarily due to lower study costs [22] - General and administrative expenses for Q1 2025 were 9.7 million in Q1 2024, mainly due to a decrease in stock-based compensation [23] Market Data and Key Metrics Changes - The market opportunity for NDV-one includes approximately 75,000 new bladder cancer cases diagnosed each year in the U.S., with about 50% classified as high-grade disease [8] - Prader Willi syndrome, the first candidate indication for sopranolone, is estimated to affect approximately 350,000 people worldwide, including about 20,000 in the U.S. [16] Company Strategy and Development Direction - The company aims to advance its pipeline with two innovative product candidates, NDV-one for bladder cancer and sopranolone for Prader Willi syndrome and Tourette syndrome, both showing promising Phase two data [5][24] - The strategic plan includes securing U.S. IND clearance for NDV-one and progressing sopranolone into clinical development in early 2026 [15][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NDV-one to improve care for bladder cancer patients, citing strong Phase two data and a favorable safety profile [14][32] - The company is optimistic about the upcoming discussions with the FDA regarding the registration study for NDV-one, highlighting the well-known efficacy and safety of the drug combination [30][32] Other Important Information - NDV-one is designed to be administered in less than ten minutes in a doctor's office, contrasting with conventional chemotherapy that requires lengthy preparation and administration [10] - The company has a clean balance sheet and a disciplined approach to its development plan, positioning it well for advancing its clinical milestones [6][25] Q&A Session Summary Question: What gives confidence that the current data from the Phase two study would be sufficient for the FDA to agree for NDV-one to move into registrational study? - Management highlighted the established use of gemcitabine and docetaxel, the safety profile of NDV-one, and the ease of administration as key factors for confidence in FDA discussions [30][32] Question: Could you elaborate on scaling up supply? - Management indicated that scaling up supply involves preparing for commercial quantities and ensuring multiple manufacturers for risk management [44] Question: When should we look forward to sharing the complete response rate for the entire population? - The next data point will be the six-month assessment, expected around June or July, with further updates planned for nine and twelve months [48][49] Question: What would you want the phase three trial to look like in terms of time points, endpoints, and types of patients? - Management discussed potential routes for the phase three trial, including a single-arm chemoablation route or a randomized trial against placebo, depending on FDA feedback [56][58]