aibioPieris (now Palvella Therapeutics) files merger partner's Phase 3 dosing news
Tickers PVLA
Palvella said the first patient was dosed in its SELVA Phase 3 trial. Later, Pieris added merger disclosures after nine stockholder demands and two lawsuits alleging disclosure gaps, which the defendants deny.
Key facts
- Company
- Palvella Therapeutics, Inc. (NASDAQ: PVLA)
- News type
- Mergers
- Primary source
- Palvella Therapeutics, Inc. 425 (2024-11-07)
Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS), the listed company now named Palvella Therapeutics, filed a Palvella Therapeutics, Inc. press release on November 7, 2024 as a communication about the two companies' planned merger. The release said the first patient had been dosed in SELVA, Palvella's Phase 3 trial of QTORIN rapamycin for microcystic lymphatic malformations.
Pieris agreed on July 23, 2024 to combine with Palvella, then a private clinical-stage company, in an all-stock transaction. A Pieris subsidiary, Polo Merger Sub, Inc., will merge into Palvella, leaving Palvella as a wholly owned subsidiary of Pieris. The release said the trial is expected to enroll approximately 40 participants and that Palvella was awarded up to $2.6 million from the FDA's Office of Orphan Products Development to support it.
Pieris's registration statement on Form S-4 for the deal was declared effective on November 8, 2024. In a later 8-K, Pieris said it had received nine demands from purported stockholders seeking more information in that registration statement. Two purported stockholders also filed lawsuits on November 15, 2024 in the Supreme Court of the State of New York, County of New York, naming Pieris and its board and alleging disclosure deficiencies.
Pieris and the other defendants deny violating any laws or breaching any duties. Pieris said it added supplemental disclosures solely to avoid the burden and expense of litigation and any disruption to the merger.