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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 (GRTX) announced positive results from its Phase 3 ROMAN trial of avasopasem, demonstrating a significant reduction in severe oral mucositis (SOM) in patients undergoing radiotherapy for head and neck cancer. The trial involved 455 patients and showed over a 50% reduction in the median duration of SOM. Avasopasem has received Breakthrough Therapy and Fast Track Designations from the FDA, with a New Drug Application submission expected by the end of 2022. Results will be presented at the ASCO Annual Meeting on June 3, 2022.
Galera Therapeutics (GRTX) plans to submit a New Drug Application (NDA) for avasopasem, targeting radiotherapy-induced severe oral mucositis, by the end of 2022. The Phase 3 ROMAN trial results will be presented at the ASCO Annual Meeting. Positive topline data from the Phase 2a AESOP trial showed avasopasem significantly reduced the incidence of severe esophagitis in lung cancer patients undergoing chemoradiotherapy. Financially, Galera reported a net loss of $15.4 million for Q1 2022, down from $18.7 million in Q1 2021, with cash reserves of $60.9 million expected to sustain operations into late 2023.
Galera Therapeutics (GRTX) announced plans to file a New Drug Application (NDA) for avasopasem by the end of 2022 to treat severe oral mucositis (SOM) resulting from radiotherapy in patients with head and neck cancer. This follows positive data from the Phase 3 ROMAN trial and the Phase 2b trial. There are currently no FDA-approved treatments for SOM, affecting over 40,000 patients annually in the U.S. The FDA has granted Fast Track and Breakthrough Therapy Designations for avasopasem.
Galera Therapeutics (GRTX) announced promising topline results from the Phase 2a AESOP trial of avasopasem, aimed at reducing severe acute radiation-induced esophagitis in lung cancer patients undergoing chemoradiotherapy. Out of 29 patients evaluated, only 2 (7%) experienced Grade 3 esophagitis, with no reports of Grade 4 or 5. This is a significant improvement compared to the 20-30% incidence reported in literature. Avasopasem was well tolerated, suggesting a potential breakthrough in treating radiation-induced toxicities.
Galera Therapeutics (GRTX) announced that clinical data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be presented at the 2022 ASCO Annual Meeting from June 3-7, 2022, in Chicago, Illinois.
The oral presentation, led by Dr. Carryn M. Anderson, is titled 'ROMAN: Phase 3 trial of avasopasem manganese for severe oral mucositis in patients receiving chemoradiotherapy for locally advanced head and neck cancer.' The abstract number is 6005.
Additionally, the Phase 2 GRECO-2 study of rucosopasem will also be included in a poster session on June 4, 2022.
Galera Therapeutics (Nasdaq: GRTX) announced successful Phase 3 ROMAN trial results for avasopasem, aiming at severe oral mucositis in head and neck cancer patients. The trial met key endpoints, leading to an upcoming FDA meeting regarding a New Drug Application (NDA). 2021 saw a net loss of $80.5 million, or $3.12 per share, with a cash reserve of $71.2 million expected to last into 2H 2023. The firm plans to report additional data in 2022 from ongoing trials for esophagitis and lung cancer treatments.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that its President and CEO, Mel Sorensen, M.D., will present at the H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will be available via webcast on January 10 at 7:00 a.m. ET on Galera's Investors page. This event highlights the company's focus on developing novel therapeutics aimed at transforming cancer radiotherapy. Galera's lead product candidates include avasopasem manganese and rucosopasem manganese, which target radiotherapy-induced toxicities and enhance treatment efficacy.
Galera Therapeutics (GRTX) announced corrected topline data from its Phase 3 ROMAN trial for avasopasem, indicating statistical significance in reducing the incidence of severe oral mucositis (p=0.045) in patients undergoing radiotherapy for head and neck cancer. The trial demonstrated a 16% relative reduction in incidence compared to placebo. The company plans to discuss this data with the FDA in 2022 and will hold a conference call on December 14. The trial results align with earlier Phase 2a EUSOM results, confirming the drug's potential in managing radiotherapy-induced toxicities.
Galera Therapeutics (Nasdaq: GRTX) announced that Mel Sorensen, M.D., CEO, will present at two investor conferences this November. The first event is the Jefferies London Healthcare Conference on November 18, 2021, available on-demand from 8:00 a.m. GMT. The second event is the Piper Sandler Annual Healthcare Conference on November 22, 2021, starting at 10 a.m. ET. Webcasts can be accessed from the investors.galeratx.com page and will be archived for 30 days.
Galera Therapeutics, Inc. (Nasdaq: GRTX) reported its Q3 2021 financial results, showcasing a net loss of $(22.6) million, or $(0.86) per share, compared to $(17.1) million, or $(0.69) per share in Q3 2020. The company maintains a solid cash position of $89 million, expected to last into 2023. Despite the Phase 3 ROMAN trial of avasopasem for severe oral mucositis not meeting its primary endpoint, it demonstrated tolerability and reduced severity duration. Enrollment continues in GRECO-1 and GRECO-2 trials for rucosopasem in lung and pancreatic cancers, with data expected in 2022.
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