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Galera Therapeutics, Inc. (Nasdaq: GRTX), headquartered in Malvern, Pennsylvania, is a clinical-stage biopharmaceutical company dedicated to transforming radiotherapy in cancer through innovative therapeutics. The company is currently focused on the development and commercialization of two primary product candidates: avasopasem manganese (avasopasem) and rucosopasem manganese (rucosopasem).
Avasopasem, a selective dismutase mimetic, has been developed to reduce radiation-induced severe oral mucositis (SOM) in patients with head and neck cancer. Despite receiving Fast Track and Breakthrough Therapy designations from the FDA, the company's New Drug Application (NDA) for avasopasem was met with a Complete Response Letter, requiring additional clinical trials for resubmission.
Rucosopasem aims to enhance the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Though rucosopasem has been granted orphan drug designation by the FDA, the company recently made the difficult decision to halt the Phase 2b GRECO-2 trial and the Phase 1/2 GRECO-1 trial due to a futility analysis of the GRECO-2 trial.
Following these setbacks, Galera has taken decisive steps to extend its cash runway, including workforce reductions and shifting focus towards strategic alternatives such as partnerships, mergers, and asset sales. As of the latest financial updates, the company estimates its balance of cash, cash equivalents, and marketable securities to support operations into the second quarter of 2024. Galera is actively evaluating these strategic options to maximize shareholder value while continuing its mission to improve cancer treatment outcomes.
For more information, visit the Investors page of Galera’s website.
Galera Therapeutics has submitted a New Drug Application (NDA) to the FDA for avasopasem, targeting severe oral mucositis (SOM) in head and neck cancer patients undergoing radiotherapy. Supported by two rigorous trials involving 678 patients, avasopasem has shown significant reductions in SOM incidence and severity. The drug, which also received Fast Track and Breakthrough Therapy designations, addresses an unmet need as no FDA-approved treatment currently exists for SOM, affecting about 42,000 U.S. patients annually.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that President and CEO Mel Sorensen, M.D., will present at the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, at 11:10 a.m. E.T. A live webcast will be available on Galera's Investors page and archived for 30 days post-event. Galera is focused on developing innovative treatments to enhance cancer radiotherapy, notably its product candidates avasopasem manganese and rucosopasem manganese, aimed at reducing toxicities and improving efficacy in cancer treatments.
Galera Therapeutics (GRTX) is poised to submit a New Drug Application (NDA) for avasopasem to the FDA by year-end 2022, aimed at treating radiotherapy-induced severe oral mucositis (SOM). Recent data presented at the ASTRO Annual Meeting revealed significant findings: tumor outcomes and overall survival rates were consistent with placebo, and a 50% reduction in chronic kidney disease incidence was noted in avasopasem patients. Financially, the company reported a reduced net loss of $16 million for Q3 2022, improving from $22.6 million in Q3 2021, supported by lower operational expenses.
Galera Therapeutics (GRTX) announced positive outcomes from its Phase 3 ROMAN trial for avasopasem, aimed at treating radiotherapy-induced severe oral mucositis (SOM) in head and neck cancer patients. One-year data demonstrated comparable tumor outcomes and overall survival between avasopasem and placebo groups. Notably, chronic kidney disease incidence in avasopasem patients was reduced by 50%. The company plans to submit a New Drug Application (NDA) to the FDA by the end of 2022, continuing its focus on addressing significant unmet needs in cancer treatment.
Galera Therapeutics (GRTX) announced significant presentations at the upcoming ASTRO Annual Meeting, scheduled for October 23-26, 2022, in San Antonio, Texas. Key highlights include tumor outcomes from the Phase 3 ROMAN trial of avasopasem for severe oral mucositis, and final data from the Phase 2 AESOP trial for chemoradiotherapy-induced esophagitis. Additionally, the company will showcase the Phase 2 EUSOM trial of avasopasem and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that its CEO, Mel Sorensen, M.D., will speak at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 4:30 p.m. E.T. A live webcast of the presentation will be available on Galera's Investors page, with an archived version accessible for 30 days post-event. Galera focuses on developing innovative therapeutics to enhance radiotherapy for cancer patients, notably its candidates avasopasem manganese and rucosopasem manganese, targeting radiotherapy-induced toxicities and enhancing cancer treatment efficacy.
Galera Therapeutics (Nasdaq: GRTX) has appointed Dr. Eugene P. Kennedy as its new Chief Medical Officer, effective immediately. Dr. Kennedy, a seasoned oncologist with over 15 years of clinical development experience, will succeed Dr. Jon T. Holmlund, who is set to retire this year. The transition aims to support the NDA submission for avasopasem, an innovative treatment for radiotherapy-induced toxicities, expected by the end of 2022. Galera's leadership believes Dr. Kennedy's expertise will enhance their long-term clinical strategy and product development.
Galera Therapeutics (GRTX) announced its progress in clinical trials and financial results for Q2 2022. The company aims to submit a New Drug Application for avasopasem by year-end 2022. An oral presentation at the ASCO Annual Meeting highlighted positive outcomes from the Phase 3 ROMAN trial for treating radiotherapy-induced oral mucositis. Phase 1 data from the GRECO-1 trial demonstrated that rucosopasem combined with SBRT was well tolerated, with signs of anti-cancer activity. The company reported a net loss of $(14.6) million for the quarter.
Galera Therapeutics (GRTX) announced promising Phase 1 results from the GRECO-1 trial of rucosopasem combined with stereotactic body radiation therapy (SBRT) for non-small cell lung cancer. Safety was confirmed, with common adverse effects, including fatigue and cough. Of seven patients, six showed tumor response or stability, with significant tumor reductions. Notably, no Grade 2-4 declines in pulmonary function were observed, contrasting previous studies. The ongoing Phase 2 stage aims to evaluate efficacy in a larger group, with enrollment expected to complete in late 2023.
Galera Therapeutics (Nasdaq: GRTX) announced that Dr. Mel Sorensen, CEO, will present at the 2022 Jefferies Healthcare Conference on June 9 at 2:00 p.m. E.T. The presentation will highlight the company's innovative therapies aimed at transforming cancer radiotherapy. Investors can access a live webcast on Galera's investor page, and an archived version will be available for 30 days post-event. Galera's leading products include avasopasem manganese and rucosopasem manganese, focused on mitigating radiotherapy-induced toxicities and enhancing treatment efficacy in specific cancers.
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