Galera Therapeutics Announces Workforce Reduction and Restructuring

Galera Therapeutics, a clinical-stage biopharmaceutical company, has announced a significant workforce reduction of 70% as part of a strategic restructuring plan. This decision comes in response to the Food and Drug Administration’s (FDA) recent decision regarding Galera’s new drug application for avasopasem manganese.

The FDA expressed concerns over the trial data’s efficacy and safety in reducing severe oral mucositis in patients with head and neck cancer. In light of this, Galera intends to request a Type A meeting with the FDA to discuss the decision’s rationale and determine the necessary steps to support a resubmission of the new drug application for approval.

Alongside the workforce reduction, Galera will also wind down its commercial readiness efforts. The company plans to allocate its resources towards defining a clear path forward for avasopasem and advancing the ongoing clinical trials for rucosopasem. Rucosopasem is Galera’s second product candidate, aimed at enhancing the anti-cancer efficacy of stereotactic body radiation therapy for patients with non-small cell lung cancer and locally advanced pancreatic cancer.

Regulatory filings indicate that as of March 1, Galera had 31 employees. The company estimates that its balance of cash, cash equivalents, and marketable securities as of June 30 stands at $38.8 million.