Uy Ear's questions to RELMADA THERAPEUTICS (RLMD) leadership • Q2 2025
Question
Uy Ear from Mizuho Financial Group inquired about the strategic direction for NDV-01 following its encouraging six-month data and a competitor's recent approval, questioning the focus between high-grade versus low-to-intermediate-grade bladder cancer. He also asked about the objectives for the upcoming FDA meeting, the potential risks of each clinical path, and the rationale behind the recent significant decrease in R&D spending.
Answer
Chief Medical Officer, Dr. Raj Pruthi, explained that while NDV-01 shows strong efficacy in high-grade disease, the low-to-intermediate-grade market presents a larger, potentially faster path to approval, citing UroGen's success as a precedent. He stated the primary goal of the FDA meeting is to discuss the viability of a similar single-arm study design. CEO Sergio Traversa clarified that the drop in R&D spending is temporary, reflecting a period without active patient enrollment, and confirmed expenses will increase in 2026 with the initiation of new trials.