Danielle Brill's questions to PALVELLA THERAPEUTICS (PVLA) leadership • Q2 2025
Question
Danielle Brill of Truist Securities asked about the enrollment pace for the Phase II TOYVA study in CVM, the rate-limiting factors for enrollment, and how to contextualize potential efficacy results compared to the MLM Phase II data, given the disease's heterogeneity.
Answer
President and CEO Wes Kaupinen confirmed the study is on track for a Q4 data readout and that the rate-limiting step is the careful selection of patients with significant cutaneous disease. He contextualized success by noting that in rare diseases with no approved therapies, an efficacy rate around 30%, combined with a clean safety profile, would be considered highly successful and supportive of advancing to a Phase III trial.