Dev Prasad's questions to Palvella Therapeutics Inc (PVLA) leadership • Q2 2025
Question
Dev Prasad of Lucid Capital Markets inquired about the anticipated clinical development timelines for the two new Qtorin programs and the company's approach to commercial manufacturing, including whether it would be in-house or with a CMO and any capacity planning.
Answer
CEO Wes Kaupinen and CSO Jeff Martini clarified that the new Qtorin rapamycin indication is closer to the clinic, while the new molecule program is expected to yield Phase II data in under 2.5 years for less than $10M. Wes Kaupinen confirmed the manufacturing strategy relies on multiple US-based third-party CDMOs for both the drug product and API, with capacity planning managed by their Head of CMC to ensure supply.