Galera Therapeutics Inc. has settled a lawsuit against Alira Health Clinical, LLC, and IQVIA Biotech, LLC, related to a statistical programming error in the Phase 3 ROMAN trial. The settlement, finalized on August 2, 2024, involves the CROs paying Galera $975,000, and the termination of contracts between the parties. The lawsuit, initially filed on May 30, 2023, in the Court of Common Pleas in Chester County, Pennsylvania, alleged breach of contract, professional negligence, and negligence.
The error occurred in 2021 during the statistical analysis for the Phase 3 ROMAN trial, which evaluated avasopasem for reducing severe oral mucositis induced by radiotherapy in patients with locally advanced head and neck cancer. Oral mucositis is a common and debilitating side effect of radiation therapy, affecting a significant portion of patients undergoing treatment for head and neck cancers. Effective management of this condition is crucial for maintaining patients' quality of life and adherence to cancer therapy.
Following the settlement, Galera filed a Praecipe to Settle, Discontinue, and End the Litigation on August 8, 2024. The company had engaged Stifel, Nicolaus & Company, Inc. as a financial advisor to explore strategic alternatives after announcing a Complete Response Letter (CRL). These alternatives aimed to maximize stockholder value and included potential mergers, asset sales, or other strategic transactions. However, stockholders did not approve the proposed Plan of Dissolution, leading the board to continue exploring available options.
The company acknowledges that these strategic evaluations may incur significant costs, including legal, accounting, and advisory fees. There is no assurance that any pursued strategic alternative will positively impact the company's operations or financial condition. Galera may also consider voluntary dissolution at a later time or seek bankruptcy protection if net assets decline to critical levels. The company urges caution regarding investments in its securities, citing speculative trading risks due to the failure to receive stockholder approval for dissolution.
