On August 9, 2023, Galera Therapeutics, Inc. announced that it had received a Complete Response Letter (CRL") from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA") for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM") in patients with head and neck cancer undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem's effectiveness and safety for reducing SOM in patients with head and neck cancer. FDA stated that results from an additional clinical trial will be required for resubmission.

The Company intends to request a Type A meeting with the FDA to understand the FDA's rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem. The Company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem.