Earnings Releases·Nov 5, 2026, 7:30 AM ET

Palvella Therapeutics — Third Quarter 2026 Earnings Summary

**Financial Results:** Net loss widened to $24.6 million ($1.70/share) from $11.3 million ($1.03/share) in the prior year period, driven by R&D expenses rising to $10.8 million and G&A expenses increasing to $11.9 million; cash and investments stood at $236.7 million as of September 30, 2026.
**Regulatory & Commercial Outlook:** The FDA granted Priority Review for the QTORIN® rapamycin NDA in microcystic lymphatic malformations with a PDUFA target date of February 28, 2027, positioning the company for a potential standalone U.S. commercial launch in the first half of 2027.
**Pipeline Progress:** Phase 3 initiation for QTORIN® rapamycin in cutaneous venous malformations and Phase 2 initiation for QTORIN® pitavastatin are both scheduled for Q4 2026, with topline results for the LOTU Phase 2 trial expected in H2 2027.
**Strategic & Leadership Updates:** The company appointed Dr. James R. Treat as Chief Medical Officer effective December 21, 2026, and plans to announce a fourth QTORIN® indication and a third product candidate in Q4 2026.