WAYNE, PA — Palvella Therapeutics, Inc. announced the recent initial closing of its Series D financing of up to $37.7 million. The financing was led by Petrichor and included new investor Gore Range Capital. Existing investors Samsara BioCapital, BVF Partners L.P., Agent Capital, Nolan Capital, and BioAdvance also participated in the financing. Tadd Wessel, Founder and Managing Partner of Petrichor, has joined the Palvella Board of Directors.
Proceeds from the financing will be used to advance the development of Palvella’s lead product candidate QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of Pachyonychia Congenita (PC), treatment of Microcystic Lymphatic Malformations (Microcystic LM), and for the prevention of Basal Cell Carcinomas (BCCs) in Gorlin Syndrome (GS). These three initial clinical indications for QTORIN™ rapamycin share similarities in the underlying disease pathology whereby the mammalian target of rapamycin, or mTOR, pathway is overactivated leading to chronically debilitating disease burdens for affected individuals. By inhibiting the mTOR pathway and limiting the systemic exposure of rapamycin, we believe QTORIN™ rapamycin has the potential to become the first approved therapy and standard of care for these indications. QTORIN™ rapamycin has received FDA Fast Track Designation for PC, Microcystic LM, and for the prevention of BCCs in GS.
“We greatly appreciate the support of our investors, new and existing, and their conviction in our ability to develop and commercialize novel therapies for serious, rare genetic skin diseases,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “The funding will accelerate our efforts to develop and commercialize QTORIN™ rapamycin for individuals suffering from Pachyonychia Congenita, Microcystic Lymphatic Malformations, and Gorlin Syndrome.”
Palvella anticipates several key catalysts within the next three fiscal quarters, including reporting Phase 2 top-line results in Microcystic LM in the first quarter of 2023, Phase 2b top-line results in GS in the first half of 2023, and Phase 3 top-line results in PC in mid-2023.
“Palvella has advanced clinical development of its product candidates in multiple underserved indications with high unmet medical need, generating compelling clinical evidence that supports the ongoing and planned Phase 3 studies,” said Mr. Wessel. “We are pleased to partner with the Palvella team to help them realize their vision of becoming the leading rare disease company focused on novel therapies for serious, rare genetic skin diseases.”
Cowen served as exclusive placement agent on the financing. Troutman Pepper Hamilton Sanders LLP served as legal counsel to Palvella.
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