Financial Data and Key Metrics Changes - Relmada closed 2025 with a cash balance of $93 million, an increase from approximately $45 million at December 31, 2024, due to net proceeds from a $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, primarily due to reduced study costs [21] - General and administrative expenses increased to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, driven by higher compensation costs [22] - 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] - The planned phase III RESCUE program will evaluate NDV-01 in both second-line BCG unresponsive disease and as adjuvant therapy for intermediate-risk bladder cancer [14][15] Market Data and Key Metrics Changes - The U.S. market for intermediate-risk bladder cancer is estimated to have about 75,000-80,000 patients, with only 35% currently receiving adjuvant therapy [53] - The second-line treatment population for BCG unresponsive patients is estimated at about 5,000 patients per year in the U.S. [15] Company Strategy and Development Direction - The company aims to initiate the phase III RESCUE program for NDV-01 in mid-2026, focusing on two independent registrational pathways [6][14] - The strategy includes addressing unmet needs in bladder cancer treatment with a unique sustained-release formulation [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical programs and long-term prospects for Relmada, highlighting the importance of execution in the upcoming RESCUE program [24] - The company anticipates 2026 to be another significant year for value creation, with the initiation of key clinical trials [8] Other Important Information - The company has strengthened its development team with the appointment of Dr. Raj S. Pruthi as Chief Medical Officer-Oncology [7] - A successful $160 million private financing was completed, providing capital through 2029 [8] Q&A Session Summary Question: Will additional data from the phase II study be presented? - Management confirmed that updated 12-month data will be presented at the AUA and plans to share data every three months as the RESCUE trial progresses [29][30] 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 [31] Question: What is the expected enrollment cadence across the studies? - Management indicated that the unique in-office profile of NDV-01 could serve as a recruitment advantage, and they expect rapid enrollment [34] Question: What is the FDA's requirement for follow-up duration prior to submitting the NDA? - The FDA has not stipulated a minimum follow-up duration but is interested in the totality of the data, including response and durability [36] Question: How does the company expect to compare against competitors in terms of CR rates? - Management indicated that they are targeting a two-year RFS of 75% and believe they can exceed this based on their data [42] Question: How does the company plan to build the market for intermediate-risk patients? - Management noted that the market is currently underserved, with only 35% receiving adjuvant therapy, and expects this number to grow as data from their studies becomes available [54]