Palvella Therapeutics and Pieris Pharmaceuticals Finalize Merger to Focus on Rare Disease Treatments

Palvella Therapeutics

WAYNE, PA — Palvella Therapeutics, Inc. has completed its merger with Pieris Pharmaceuticals, Inc., forming a unified company under the name Palvella Therapeutics, Inc. Shares of the newly combined company will begin trading on the Nasdaq Capital Market on December 16, 2024, under the ticker symbol “PVLA.” The merger positions the company as a leader in rare disease biopharmaceuticals, advancing a late-stage clinical pipeline aimed at addressing serious, rare genetic conditions.

The post-merger entity is led by Palvella Founder and CEO Wes Kaupinen and supported by a leadership team dedicated to advancing innovative therapies. Backed by approximately $80 million in cash, including proceeds from a private placement financing co-led by BVF Partners, L.P., and Frazier Life Sciences, the company is financially prepared to fund operations into the second half of 2027.

A key focus is the continued development of QTORIN™ rapamycin, a patented anhydrous gel designed to treat microcystic lymphatic malformations (microcystic LMs) and cutaneous venous malformations (cutaneous VMs). QTORIN™ rapamycin represents a potential first-in-class therapy for these conditions, which affect thousands in the United States. The drug has received critical designations from the FDA, including Breakthrough Therapy, Fast Track, and Orphan Drug status for microcystic LMs.

“Palvella is well-positioned to enter the public markets and deliver on our vision of becoming the leading rare disease company,” said Wes Kaupinen, CEO of Palvella Therapeutics. “This merger enables us to accelerate the development of QTORIN™ rapamycin, while continuing to expand our QTORIN™ platform to address additional rare genetic skin diseases.”

The company’s lead product, QTORIN™ rapamycin, is currently in a Phase 3 SELVA clinical trial for microcystic LMs and a Phase 2 trial for cutaneous VMs. Palvella is leveraging its patented delivery platform to enhance therapeutic precision while minimizing systemic side effects often associated with treatments for rare genetic diseases.

The merger also incorporated a private equity infusion from respected healthcare investors such as Blue Owl Healthcare Opportunities and Nantahala Capital. Palvella now holds a controlling stake in the combined company, with Pieris shareholders retaining contingent rights related to legacy assets, including partnerships with Pfizer and Boston Pharmaceuticals.

With a strong financial foundation, focused leadership, and a clear mission, Palvella Therapeutics is poised to deliver groundbreaking therapies for rare genetic diseases while driving long-term growth in the biopharmaceutical sector.

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