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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) reported its Q1 2021 financial results, showing a net loss of $(18.7) million or $(0.75) per share. Research and development expenses decreased to $12.4 million, while general and administrative expenses rose to $5.1 million. The company highlighted significant advancements in clinical trials, including a near doubling of median overall survival in a Phase 1/2 trial for pancreatic cancer. The Phase 3 ROMAN trial in severe oral mucositis is expected to complete enrollment in 1H21, with topline data anticipated in 2H21.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that its CEO, Mel Sorensen, M.D., will present at the BofA Securities 2021 Virtual Healthcare Conference on May 12, 2021, at 8:45 a.m. ET. The presentation can be viewed live on the company's Investors page, with an archived version available for 30 days post-event.
Galera is focused on innovative therapeutics for cancer treatment, notably avasopasem manganese (GC4419), aimed at reducing severe oral mucositis from radiotherapy. Various clinical trials are ongoing to evaluate its effectiveness in multiple cancer types.
Galera Therapeutics (GRTX) reported significant findings from its Phase 1/2 pilot trial of GC4419 in patients with locally advanced pancreatic cancer (LAPC). The median overall survival was 20.1 months for patients receiving GC4419 plus SBRT, nearly double the 10.9 months seen with placebo. The trial also demonstrated improvements in local tumor control, time to metastasis, and progression-free survival. The upcoming Phase 2b GRECO-2 trial aims to enroll 160 patients, further exploring the efficacy of GC4711 combined with SBRT.
Galera Therapeutics (GRTX) announced its financial results for Q4 and the full year 2020, reporting a net loss of $20.1 million for Q4 and $74.2 million for the year. Research and development expenses rose to $54.8 million due to trials related to avasopasem. The company remains on track for pivotal data readouts in 2021, including results from the Phase 3 ROMAN trial for Severe Oral Mucositis and the Phase 1/2 trial in pancreatic cancer. As of December 31, 2020, cash on hand was $72.8 million, which is expected to fund operations into H2 2022.
Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that its CEO, Mel Sorensen, M.D., will present at the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 1:50 p.m. ET. A live webcast of the presentation will be available on the company's Investors page, with an archived version accessible for 30 days post-event.
Galera is focused on developing innovative therapies for cancer treatment, including avasopasem manganese (GC4419), aimed at reducing radiation-induced oral mucositis. The drug is under various trials, including Phase 3 and Phase 2 studies.
MALVERN, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company, announced that Mel Sorensen, M.D., CEO, will engage in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. The pre-recorded event will be available from November 23, 2020, on Galera's Investor page for 60 days. Galera focuses on innovative therapeutics for cancer radiotherapy, including lead candidate avasopasem manganese (GC4419), targeting radiation-induced severe oral mucositis.
Galera Therapeutics (GRTX) reported promising interim data from its placebo-controlled pilot trial of GC4419 combined with SBRT for pancreatic cancer, showcasing improved tumor responses and potential survival benefits. The company also initiated the GRECO-1 Phase 1/2 trial for NSCLC and remains on track with the ongoing Phase 3 ROMAN trial. For Q3 2020, Galera's R&D expenses increased to $12.1 million, leading to a net loss of $(17.1) million. However, the company has sufficient cash reserves of $89.2 million to support operations into H2 2022.
Galera Therapeutics (Nasdaq: GRTX) announced that Mel Sorensen, M.D., its CEO, will present at the 29th Annual Credit Suisse Virtual Healthcare Conference on November 10, 2020, at 11:45 a.m. ET. A live webcast of the presentation will be available on the investors page of Galera's website, with an archived version accessible for 30 days post-event. Galera is focused on developing innovative therapeutics for cancer treatment, notably avasopasem manganese, aimed at reducing severe oral mucositis from radiotherapy.
Galera Therapeutics (GRTX) has announced interim results from its Phase 1/2 clinical trial of avasopasem manganese (GC4419) combined with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). The trial included 42 patients, revealing that the median overall survival in the GC4419 group was not reached, while the placebo group had a median of 38.7 weeks (p=0.06). Seven patients underwent surgical resection, achieving favorable outcomes. The study highlights the potential for GC4419 to enhance treatment efficacy, warranting further investigation.
Galera Therapeutics (GRTX) has released interim data from its pilot Phase 1/2 clinical trial of avasopasem manganese (GC4419) combined with stereotactic body radiation therapy (SBRT) for locally advanced pancreatic cancer. The results show that the median overall survival for the treatment group has not yet been reached, compared to 40.4 weeks for the placebo group (HR=0.3; p=0.046). The trial also indicated better progression-free survival and locoregional control. Full data from 42 patients will be presented at the ASTRO meeting on October 27.
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