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 announced the issuance of U.S. Patent No. 12,636,273 by the United States Patent and Trademark Office. The issued patent, exclusively licensed by Palvella from Yale University, supports the Company's QTORIN™ pitavastatin program for porokeratosis, including disseminated superficial actinic porokeratosis (DSAP).

"This issued patent strengthens the IP position supporting QTORIN™ pitavastatin and represents an important step in advancing our pathogenesis-directed approach to porokeratosis," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella Therapeutics. "QTORIN™ pitavastatin is designed to combine a potent, next-generation statin with Palvella's QTORIN™ platform to enable pathogenesis-directed inhibition of the mevalonate pathway on-target and directly within DSAP-affected tissue. We believe QTORIN™ pitavastatin has the potential to become a first-in-disease therapy for DSAP, a serious, rare, premalignant genetic skin disease affecting an estimated more than 50,000 diagnosed patients in the U.S., with no FDA-approved therapies."

The issued patent, exclusively licensed from Yale University, strengthens Palvella's intellectual property position supporting QTORIN™ pitavastatin for porokeratosis, including DSAP. Building on pioneering work by Keith Choate, M.D., Ph.D., Chair and Professor of Dermatology, Pathology, and Genetics at Yale School of Medicine, the issued claims cover topical administration of HMG-CoA reductase inhibitors, including pitavastatin, for the treatment of porokeratosis, providing protection into 2043 for this pathogenesis-directed treatment approach. In addition to the newly issued Yale IP, Palvella has filed an additional pending application covering the novel  QTORIN-derived formulation of pitavastatin and other statins and methods of use.

QTORIN™ pitavastatin is an investigational topical therapy designed to enable pathogenesis-directed inhibition of the mevalonate pathway on-target and directly within affected skin tissue in porokeratosis. Developed with Palvella's proprietary QTORIN™ platform for generating novel topical therapies for serious, rare skin diseases and vascular malformations, QTORIN™ pitavastatin combines a potent, next-generation statin with Palvella's targeted topical approach. Palvella plans to initiate a Phase 2 clinical trial in DSAP in the second half of 2026.