GALERA THERAPEUTICS INC - GRTX STOCK NEWS

Galera Therapeutics announces financial results for Q1 2023 and recent corporate updates, including FDA priority review for avasopasem NDA and $30 million raised in direct offering.

Galera Therapeutics, a clinical-stage biopharmaceutical company, has appointed new sales, market access, and commercial operations executives to its senior commercial leadership team. The team will be responsible for preparing for the potential U.S. commercial launch of avasopasem, a new oncology product. The appointments include Patrick Campbell as VP of Sales & Account Management, Elizabeth Turner as VP of Market Access, and Henning Thorsen as VP of Commercial Operations.

Galera Therapeutics (Nasdaq: GRTX) announced a significant finding from the Phase 3 ROMAN trial that focuses on reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer. This analysis will be presented at the 2023 ASCO Annual Meeting scheduled for June 2-6, 2023 in Chicago, IL. The presentation, titled One-year reductions in CKD in patients with HNC cancer treated with avasopasem manganese, is set for June 5, 2023, from 1:15 PM to 4:15 PM ET. Avasopasem is currently under priority review by the FDA for severe oral mucositis, with a decision expected by August 9, 2023.

Galera Therapeutics, Inc. (Nasdaq: GRTX) announced a net treatment benefit analysis of the Phase 3 ROMAN trial results at the 10th ECHNO conference in Lisbon, Portugal, highlighting its drug avasopasem manganese's impact on severe oral mucositis (SOM) in head and neck cancer patients. The company’s New Drug Application (NDA) for avasopasem is currently under priority review by the FDA with a PDUFA date set for August 9, 2023. Galera is in discussions with European regulatory authorities for potential approval in Europe, emphasizing the drug's first-in-class potential to improve patient quality of life following radiotherapy.

Galera Therapeutics (GRTX) announced a pivotal year ahead with FDA's Priority Review for its NDA on avasopasem, aimed at reducing radiotherapy-induced severe oral mucositis (SOM) in head and neck cancer patients. The PDUFA target date is set for August 9, 2023. The company raised $30 million through a direct offering to support operations and upcoming commercial efforts. Financially, Q4 2022 showed research and development expenses of $8.1 million, with a net loss narrowing to $(16.2) million. For the entire year, 2022's net loss was $(62.2) million, a significant improvement from $(80.5) million in 2021.

Galera Therapeutics (GRTX) announced a registered direct offering of 14,320,000 shares of common stock and accompanying warrants at an offering price of $2.095 per share. The gross proceeds are expected to be approximately $30 million before fees and expenses. The warrants are set to expire five years from issuance and have an exercise price of $1.97 per share. This offering is slated to close around February 17, 2023, pending customary conditions. Galera is actively pursuing the development of innovative cancer therapeutics, with avasopasem under priority review by the FDA for treating radiation-induced oral mucositis.

Galera Therapeutics, Inc. (GRTX) announced that the FDA has accepted its New Drug Application (NDA) for avasopasem manganese, targeting radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC). This priority review designation has set a PDUFA target date of August 9, 2023.

Avasopasem, if approved, would be the first drug to address SOM, impacting approximately 42,000 patients annually in the U.S. The NDA is backed by two significant clinical trials, showing meaningful reductions in SOM incidence and severity, suggesting potential cost savings by reducing hospitalizations and treatment interruptions.