Palvella Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Update

New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs) on track for planned submission in second half of 2026

Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic LMs; potential to become the first FDA-approved therapy and first-line, standard-of-care treatment for serious, lifelong disease affecting an estimated more than 30,000 diagnosed patients in the U.S.

Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026

Initiation of Phase 2 trial of QTORIN™ rapamycin for the treatment of clinically significant angiokeratomas planned for second quarter of 2026

Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis planned for second half of 2026

Pro forma cash of approximately $274 million as of December 31, 2025 reflects net proceeds from a February 2026 equity financing; cash and cash equivalents of $58.0 million as of December 31, 2025

Company to host conference call at 8:30 a.m. ET today

WAYNE, Pa., March 31, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today reported financial results for the full year ending December 31, 2025 and provided a corporate update.

“2025 was a landmark year for Palvella, and we carried that momentum into 2026 with positive Phase 3 SELVA results in microcystic lymphatic malformations, marking a major milestone for the company and putting us on a path toward our first potential FDA approval in the first half of 2027,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Following SELVA results, we significantly strengthened our balance sheet through an oversubscribed $230.0 million financing, enabling us to accelerate U.S. launch readiness and continue advancing novel topical product candidates from our QTORIN™ platform. Supported by Breakthrough Therapy, Fast Track, and Orphan designations, we are now focused on advancing QTORIN™ rapamycin toward an NDA submission while preparing for a planned standalone U.S. commercial launch. We believe this momentum positions us to advance our vision of building the leading rare disease biopharmaceutical company addressing serious, rare skin diseases and vascular malformations with no FDA-approved therapies.”

Recent Research and Development Highlights

QTORIN™ rapamycin for microcystic LMs

• In February 2026, reported positive topline results from the Phase 3 SELVA study:
  • Primary endpoint met with statistically significant improvement (mean change of +2.13; p