Ed Arce's questions to TALPHERA (TLPH) leadership • Q2 2025
Question
Ed Arce from WestPark Capital asked for clarification on the expected enrollment acceleration for the NEFRO study and inquired about leveraging data from the compassionate use program for future publications or commercial support.
Answer
CEO Vincent Angotti stated that the enrollment target can be met by maintaining the current per-site run rate as new, larger sites are added, not necessarily by accelerating the rate at existing sites. Chief Medical Officer Dr. Shakil Aslam added that data from the compassionate use program, while not for the primary efficacy submission, will be included in the safety dataset for the FDA and used for publications to support commercial efforts, particularly for patient populations with contraindications to existing anticoagulants.