US-based Palvella Therapeutics (Nasdaq: PVLA) announced the commencement of an underwritten public offering of USD 150 million of shares of its common stock. The Palvella Therapeutics public offering includes an option for underwriters to purchase up to an additional USD 22.5 million of common stock, bringing the maximum potential size of the transaction to USD 172.5 million. No closing date was specified.
Palvella stated it intends to use net proceeds to support the development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, as well as for working capital and general corporate purposes.
Company overview and pipeline
Palvella Therapeutics is a specialist in rare skin disease therapeutics and vascular malformations for which no FDA-approved treatments currently exist. The firm’s pipeline is built around its proprietary QTORIN platform, a patented drug delivery technology for topical formulations. The lead product candidate is QTORIN 3.9% rapamycin anhydrous gel, a topical formulation of the mTOR inhibitor rapamycin.
QTORIN rapamycin is currently in development for three indications: microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. The program in microcystic lymphatic malformations is the most advanced, with a Phase III trial (SELVA) under way. Microcystic lymphatic malformations are chronic, disfiguring conditions characterized by clusters of fluid-filled vesicles, typically affecting the skin and mucosal surfaces, with no FDA-approved treatment. A Phase II trial in cutaneous venous malformations is also in progress.
Palvella’s second product candidate, QTORIN pitavastatin, is a topical formulation being developed for disseminated superficial actinic porokeratosis, a chronic skin disorder characterized by multiple keratotic lesions.