Galera Therapeutics Inc.

08/08/2024 | Press release | Distributed by Public on 08/08/2024 18:01

Regulation FD Disclosure Form 8 K

Item 7.01 Regulation FD Disclosure.

On May 30, 2023, Galera Therapeutics, Inc. (the "Company") filed a lawsuit in the Court of Common Pleas in Chester County, Pennsylvania, or the Court, against Alira Health Clinical, LLC and IQVIA Biotech, LLC, (the "CROs"), seeking damages and alleging breach of contract, professional negligence, and negligence related to an error by the defendants in 2021 in their statistical program for the Phase 3 ROMAN trial of avasopasem for the reduction of severe oral mucositis induced by radiotherapy in patients with locally advanced head and neck cancer (the Phase 3 ROMAN trial) (the "Litigation"). Galera and the CROs have entered into an agreement to settle the Litigation, pursuant to which, in exchange for mutual releases, the CROs have paid to Galera the amount of $975,000, and the parties have terminated the contracts between Galera and the CROs, with no further obligations under the parties' contracts. The Company expects to file a Praecipe to Settle, Discontinue, and End the Litigation on or before August 8, 2024.