Palvella Therapeutics Announces Closing of Merger with Pieris Pharmaceuticals and Concurrent Private Placement of $78.9 Million
Summary
Palvella Therapeutics to debut on Nasdaq under the ticker symbol PVLA as a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic diseasesStrong balance sheet with approximately $80.0 million of cash and cash equivalents, including proceeds from a PIPE financing co-led by BVF Partners, L.P. and Frazier Life SciencesCash expected to fund operations into the second half of 2027, including through Phase 3 SELVA clinical trial of QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) and Phase 2 clinical trial in cutaneous venous malformations (cutaneous VMs)Microcystic LMs is a chronically debilitating and lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S.QTORIN rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs and cutaneous VMsWAYNE, Pa., Dec. 13, 2024 (GLOBE NEWSWIRE) -- (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the completion of its previously announced merger with Pieris Pharmaceuticals, Inc. (Pieris). Holders of the CVR will be entitled to receive payments from proceeds received by the combined company, if any, under Pieris existing partnership agreements with Pfizer and Boston Pharmaceuticals, in addition to other potential licensing agreements involving certain of Pieris legacy assets, as well as certain potential payments related to historical research and development tax credits, which may or may not be realized.TD Cowen served as lead placement agent and Cantor served as a placement agent for Palvellas concurrent financing. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis that can cause hospitalization. The natural history of microcystic LMs are persistent and progressive without spontaneous resolution, with symptoms generally worsening during life, including increases in the number and size of malformed vessels that lead to complications and lifetime morbidity. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature.