Relmada Therapeutics(RLMD) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Relmada closed 2025 with a cash balance of $93 million, an increase from approximately $45 million at the end of 2024, primarily due to a successful $160 million private financing [19][20] - Research and development expenses for Q4 2025 totaled $8.1 million, a decrease from $11 million in Q4 2024, driven by reduced study costs from completed trials [20] - General and administrative expenses increased to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, primarily due to higher compensation costs [21] - The net loss for Q4 2025 was $19.9 million, or $0.27 per share, compared to a net loss of $18.7 million, or $0.62 per share, in Q4 2024 [23] Business Line Data and Key Metrics Changes - The NDV-01 program reported a 12-month complete response rate of 76% in high-risk NMIBC patients, with an 80% response rate in the BCG unresponsive population [11][12] - Sepranolone is preparing for a proof of concept study in Prader-Willi syndrome, with plans to initiate in mid-2026 [18] Market Data and Key Metrics Changes - The U.S. market for intermediate-risk bladder cancer patients is estimated at 70,000-75,000 annually, while the second-line treatment for BCG unresponsive patients is about 5,000 annually [13][15] - Only 35% of intermediate-risk patients currently receive adjuvant therapy, indicating significant market potential for new treatments [53] Company Strategy and Development Direction - The company plans to initiate the phase 3 RESCUE program for NDV-01 in mid-2026, with two registrational pathways focusing on intermediate-risk and BCG unresponsive patients [5][13] - The strategic focus includes enhancing clinical data presentation and establishing a robust supply chain for sepranolone [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical programs and long-term prospects, emphasizing the importance of execution in the upcoming RESCUE program [24][57] - The company aims to redefine the standard of care in bladder cancer with NDV-01, leveraging its unique sustained-release formulation [17] Other Important Information - The company has strengthened its development team with the appointment of Dr. Raj S. Pruthi as Chief Medical Officer-Urology [6] - A successful $160 million private financing was completed, providing capital through 2029 [8][20] Q&A Session Summary Question: Will additional data from the phase two study be presented? - Management confirmed that updated 12-month data will be presented at AUA and plans to share data every three months [26][29] Question: How will the company ensure that second-line patients are accurately categorized? - The company will limit prior therapy lines to two and will monitor patient characteristics closely to ensure accurate categorization [27][30] Question: What is the expectation for enrollment cadence across the studies? - Management indicated that the unique in-office profile of NDV-01 could serve as a recruitment advantage, despite a crowded market [34][35] Question: What is the FDA's requirement for follow-up duration before submitting the NDA? - The FDA has not stipulated a minimum follow-up duration but is interested in the totality of the data regarding response and durability [36] Question: How do the complete response rates compare between phase 2 and phase 3? - Management expects to exceed the benchmark of 75% two-year recurrence-free survival based on the statistics structured for the trial [42]