QTORIN pitavastatin

May 7, 2026: Palvella Therapeutics, Inc. (NASDAQ: PVLA) reported Q1 2026 financial results and provided pipeline/regulatory updates for its QTORIN™ platform.

QTORIN™ rapamycin (3.9% anhydrous gel) — microcystic lymphatic malformations (microcystic LMs): The company reported positive topline Phase 3 SELVA results with statistically significant outcomes on the primary and all pre-specified secondary endpoints. FDA granted a Pre-NDA meeting, expected in Q2 2026; NDA submission remains on track for 2H 2026. SELVA data will be presented at the ISSVA World Congress 2026 on May 20, 2026.

QTORIN™ rapamycin — cutaneous venous malformations (cutaneous VMs): Phase 2 TOIVA results are slated for presentation at the Society for Investigative Dermatology meeting (May 12, 2026) and ISSVA World Congress (May 20, 2026). An FDA Breakthrough Therapy Designation application was submitted in Q2 2026. Phase 3 initiation is anticipated in 2H 2026.

QTORIN™ rapamycin — clinically significant angiokeratomas: First patients dosed in the Phase 2 LOTU trial; topline results expected in 2H 2027.

QTORIN™ pitavastatin — disseminated superficial actinic porokeratosis (DSAP): Phase 2 trial initiation expected in 2H 2026.

Corporate: Completed an upsized, oversubscribed equity offering (February 2026) raising $230.0M gross; cash/cash equivalents/short-term investments were $261.9M as of March 31, 2026.