Financial Data and Key Metrics Changes - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $13.9 million, down from $44.9 million as of December 31, 2024, excluding net proceeds of approximately $94 million from a recent $100 million underwritten offering [19][20] - The net loss for Q3 2025 was $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share for Q3 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 totaled $4 million, a decrease of $7.1 million from $11.1 million in Q3 2024, primarily due to lower study costs [21] - General and administrative expenses for Q3 2025 were $6.3 million, down from $11.9 million in Q3 2024, driven by a decrease in stock-based compensation and administrative expenses [22] Market Data and Key Metrics Changes - The company is developing NDV-01 for non-muscle-invasive bladder cancer (NMIBC), which affects about 68,000 new patients annually in the U.S. and has a prevalence of approximately 744,000 patients [4][9] - Sopranalone is being developed for Prader-Willi syndrome, which has a U.S. prevalence of approximately 20,000 patients [5] Company Strategy and Development Direction - The company aims to advance two late-stage clinical programs: NDV-01 for NMIBC and Sopranalone for Prader-Willi syndrome, with both expected to initiate studies in the first half of 2026 [6][19] - The FDA has aligned on key elements of the phase 3 program for NDV-01, allowing for two distinct registrational tracks, which is seen as a significant de-risking milestone [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the NDV-01 clinical development program based on positive nine-month results and constructive discussions with the FDA [17] - The company is well-capitalized following a recent $100 million financing, which is expected to support operations into 2028 [6][20] Other Important Information - The company has established a clinical advisory board for NDV-01, chaired by a renowned urologic oncologist, to provide guidance for the pivotal program [8] - The company plans to initiate a proof of concept study for Sopranalone in the first half of 2026 [19] Q&A Session Summary Question: Can you help us understand the market opportunity for the two indications and the sequence of studies? - The refractory second-line BCG unresponsive population is about 8,000 patients annually, while the intermediate-risk population is estimated at 80,000 patients, with over half likely to receive adjuvant therapy [25][27] - Both trials are planned to start in Q2 2026, with the refractory study expected to provide three-month data by Q4 2026 and top-line data by Q2 2028 [29] Question: What potential pricing could look like? - Current therapies set a benchmark around $700,000 for the first year, and the company will base pricing on data and market reception [30][32] Question: How does the product's ease of use open up the market? - The new formulation allows for a five-minute installation without the need for specialized pharmacies, making it more accessible for community urologists [34][35] Question: What if the BRIDGE study succeeds? - If the BRIDGE study shows that gemcitabine and docetaxel are non-inferior to BCG, it could significantly expand the market opportunity for the product, especially in off-label use [36][38]