Palvella Therapeutics and Pieris Pharmaceuticals Reach Merger Agreement
25 July 2024
Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in novel treatments for rare genetic skin disorders without FDA-approved options, has agreed to merge with Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS) in an all-stock transaction. The merger will result in a new entity named Palvella Therapeutics, Inc., based in Wayne, PA, and listed on The Nasdaq Capital Market.
The merger will be supported by a concurrent private financing of $78.9 million, led by BVF Partners, L.P., and Frazier Life Sciences, with participation from several new and existing investors. This financing includes $18.9 million from convertible notes issued by Palvella, which will convert into shares of the merged company.
Post-merger, the new company will have approximately $80.5 million in cash and equivalents, expected to fund operations and clinical milestones through mid-2027. The merger is anticipated to finalize in the fourth quarter of 2024, contingent on shareholder approval and regulatory conditions.
Palvella’s flagship product, QTORIN™ 3.9% rapamycin anhydrous gel, is designed to address severe genetic skin diseases driven by mTOR pathway overactivation. This gel is currently in development for microcystic lymphatic malformations (microcystic LMs), a rare condition marked by abnormal lymphatic vessels that leak and bleed, affecting over 30,000 U.S. patients with no FDA-approved treatments.
QTORIN™ rapamycin has received FDA Breakthrough Therapy Designation for microcystic LMs, following positive Phase 2 trial results. The FDA has also granted Fast Track and Orphan Drug Designations for this therapy. A pivotal Phase 3 trial, named SELVA, will commence in the third quarter of 2024.
Furthermore, Palvella is developing QTORIN™ rapamycin for cutaneous venous malformations, another rare genetic disorder involving abnormal vein growth. The FDA granted Fast Track Designation for this indication in April 2024, and a Phase 2 trial is expected to begin in the latter half of 2024.
Source: palvellatx.com
