Palvella Therapeutics and Pieris Pharmaceuticals to Merge
DENVER, Colo., Jul 24, 2024 (247marketnews.com)- Palvella Therapeutics, Inc. and Pieris Pharmaceuticals, Inc. (Nasdaq:PIRS) announced that they agreed to an all-stock merger transaction and combine the companies, which will focus on developing and commercializing Palvella’s lead clinical product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), for the treatment of microcystic lymphatic malformations (microcystic LMs), cutaneous venous malformations, and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway.
Once combined, the company will operate under the name Palvella Therapeutics, Inc., and is expected to trade on The Nasdaq Capital Market (Nasdaq).
Palvella’s Founder and CEO, Wes Kaupinen, stated, “We are pleased to announce our merger with Pieris, allowing Palvella to become a publicly traded company and pursue our vision of becoming the leading rare disease company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases.
“The expected proceeds from the merger and concurrent private financing are expected to fund us through multiple clinical trial milestones, including generating results from the single-arm, baseline-controlled Phase 3 clinical trial of QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, a serious, rare and chronically debilitating genetic disease for which there are currently no FDA-approved therapies.”
Palvella secured commitments from a healthcare-dedicated investor syndicate in an oversubscribed $78.9 million private financing that’s concurrent with the proposed merger.
Stephen S. Yoder, President and CEO of Pieris, commented, “This transaction represents Pieris’ deep commitment to delivering value to its stockholders by preserving the future potential milestone and royalty streams from our partnered immuno-oncology bispecifics franchise for Pieris legacy stockholders through the CVRs, while also providing the opportunity for upside in an attractive, late-stage, rare disease company.
“With the anticipated funding and an accomplished management team, we believe Palvella is well-positioned to advance a Phase 3 clinical program with the FDA’s Breakthrough, Fast Track, and Orphan Drug Therapy Designations. This transaction is the culmination of a comprehensive review of strategic alternatives, and our board of directors believes that the merger with Palvella is in the best interests of our stockholders.”
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