Annual Report · 10-K
Palvella Therapeutics, Inc.
Annual Report
Company context
We are a clinical-stage biopharmaceutical company whose vision is to become the leading rare disease biopharmaceutical company focused on developing and, if approved, commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases, for which there are no FDA approved therapies. We intend to leverage our versatile QTORIN™ platform to treat these patients. The QTORIN platform is designed to generate new therapies that penetrate the deep layers of the skin to locally treat a broad spectrum of rare, genetic skin diseases. Our lead product candidate, QTORIN 3.9% rapamycin anhydrous topical gel, or “QTORIN rapamycin”, is in clinical development for two of these diseases: microcystic lymphatic malformations, or “microcystic LM”, and cutaneous venous malformations. QTORIN rapamycin contains the active pharmaceutical ingredient rapamycin, also known as sirolimus, which is an inhibitor of mammalian target of rapamycin, or “mTOR”, a kinase that plays a key role in cell growth and proliferation. The QTORIN platform is novel and has only generated one program to date, QTORIN rapamycin, and clinical evidence to support this candidate is preliminary and limited at this time.
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