Matthew Barcus's questions to RELMADA THERAPEUTICS (RLMD) leadership • Q1 2025
Question
Matthew Barcus from Jefferies inquired about the timeline for the complete response rate data for the full NDV-01 patient cohort, future data updates, and the company's ideal design for a potential Phase III trial, including endpoints and patient populations.
Answer
Executive Sergio Traversa stated that 6-month data for the initial 20 patients in the NDV-01 study will be available around June/July, with 9 and 12-month data to follow. Dr. Yair Lotan, a clinical expert, highlighted that the safety profile is the most reassuring aspect of the data so far. For the Phase III design, Dr. Lotan outlined two potential efficient pathways: a single-arm chemoablation trial, pending FDA's view on a similar competitor product, or a randomized trial against placebo in intermediate-risk patients, which he noted would likely enroll quickly.