GRTX Galera Therapeutics Inc.

1.82
-0.18  -9%
Previous Close 2.01
Open 1.95
52 Week Low 1.96
52 Week High 15
Market Cap $48,117,278
Shares 26,365,632
Float 15,528,662
Enterprise Value $-9,912,204
Volume 3,089,080
Av. Daily Volume 838,867
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Upcoming Catalysts

Drug Stage Catalyst Date
GC4711 (GRECO-1)
Non-Small Cell Lung Cancer (NSCLC)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Avasopasem (GC4419) - ROMAN
Oral mucositis
Phase 3
Phase 3
Phase 3 completion of enrollment announced June 28, 2021. Phase 3 trial did not meet primary endpoint, noted October 19, 2021.
Avasopasem (GC4419)
Pancreatic cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial final results announced - GC4419 was well tolerated, with similar rates of early and late adverse events in the active and placebo arms September 8, 2021.
GC4711 (GRECO-2)
Pancreatic Cancer
Phase 2b
Phase 2b
Phase 2b initiated in May 2021
Avasopasem (GC4419) - (AESOP)
Esophagitis
Phase 2a
Phase 2a
Phase 2a top-line data due 1H 2022.

Latest News

  1. Primary endpoint of reduction in incidence of severe oral mucositis (SOM) not met

    Trial demonstrated relative reduction in all key SOM endpoints, including more than halving the median duration

    Avasopasem was generally well tolerated compared to placebo

    MALVERN, Pa., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced results from the Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy…

    Primary endpoint of reduction in incidence of severe oral mucositis (SOM) not met

    Trial demonstrated relative reduction in all key SOM endpoints, including more than halving the median duration



    Avasopasem was generally well tolerated compared to placebo

    MALVERN, Pa., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced results from the Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company is continuing to analyze the results.

    "While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint," said Mel Sorensen, M.D., Galera's President and CEO. "We would like to extend our heartfelt thanks to the patients who participated in this trial while they underwent radiotherapy for head and neck cancer. As we evaluate next steps for this program, we remain committed to our goal of transforming radiotherapy in cancer treatment with our selective dismutase mimetics."

    Key findings include:

    • 16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%) (p=0.113) (primary endpoint)
    • 56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days) (p=0.011) (secondary endpoint)
    • 27% relative reduction in the severity (incidence of Grade 4 OM) of SOM in the avasopasem treatment group (24%) vs. placebo group (33%) (p=0.167) (secondary endpoint)
    • Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms

    Dr. Sorensen continued, "We continue to be excited about the potential of our second dismutase mimetic product candidate, GC4711, in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC) and locally advanced pancreatic cancer (LAPC). We recently initiated a Phase 2b trial of GC4711 in combination with SBRT in LAPC based on promising tumor and survival outcome benefits observed in a Phase 1/2 pilot trial. In addition, enrollment is ongoing in a Phase 1/2 trial of GC4711 in combination with SBRT in patients with NSCLC. We look forward to providing updates as these trials progress." 

    The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients with locally advanced HNC receiving seven weeks of standard-of-care radiotherapy plus cisplatin. Patients were randomized to one of the two treatment groups (3:2) to receive 90 mg of avasopasem or placebo by infusion on the days they receive their radiation treatment.

    About Oral Mucositis

    Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration and bleeding of the mouth. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy for head and neck cancer develop severe oral mucositis (SOM), defined by the inability to eat solid food (Grade 3) or drink liquids (Grade 4). The impact on patients who develop SOM is substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat SOM.

    About Avasopasem

    Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

    About the Phase 3 ROMAN Trial

    The ROMAN trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the ability of avasopasem to reduce the incidence and severity of radiation-induced SOM in patients with locally advanced head and neck cancer, receiving seven weeks of radiotherapy plus cisplatin. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03689712.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's technology consists of selective small molecule dismutase mimetics that are in late-stage development in patients with cancer. Avasopasem is in development for radiotherapy-induced toxicities, including SOM in patients with head and neck cancer and esophagitis in patients with lung cancer. Avasopasem has been granted FDA Fast Track and Breakthrough Therapy designations for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: expectations surrounding the continued advancement of our product pipeline; the potential safety and efficacy of Galera's product candidates and their regulatory and clinical development, including the interpretation of the safety and efficacy results from the Phase 3 ROMAN trial and expectations surrounding the progress of the Phase 2b trial of GC4711 in patients with LAPC and the Phase 1/2 trial of GC4711 in patients with NSCLC; the Company's ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics; and the potential of GC4711 to augment the anti-cancer efficacy of SBRT in patients with NSCLC and LAPC. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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  2. MALVERN, Pa., Oct. 12, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the appointment of Mark J. Bachleda, Pharm.D., M.B.A., as Chief Commercial Officer (CCO) and Jennifer Evans Stacey, Esq., as Chief Legal and Compliance Officer (CLCO) and Secretary. Both executives join Galera with over 25 years of leadership experience within the biopharmaceutical industry.

    "We are thrilled to welcome Mark and Jennifer to Galera at this critical point in the Company's growth," said Mel Sorensen, M.D., Galera's President and CEO…

    MALVERN, Pa., Oct. 12, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the appointment of Mark J. Bachleda, Pharm.D., M.B.A., as Chief Commercial Officer (CCO) and Jennifer Evans Stacey, Esq., as Chief Legal and Compliance Officer (CLCO) and Secretary. Both executives join Galera with over 25 years of leadership experience within the biopharmaceutical industry.

    "We are thrilled to welcome Mark and Jennifer to Galera at this critical point in the Company's growth," said Mel Sorensen, M.D., Galera's President and CEO. "As we begin to expand our focus toward becoming a commercial-stage company, we will leverage our two new colleagues' executive-level experiences to continue shaping Galera's corporate and regulatory strategy. We look forward to their invaluable contributions that will help position us to achieve our mission of delivering novel therapies that improve outcomes for patients with cancer undergoing radiotherapy."

    Prior to joining Galera, Mark served as Vice President & U.S. Business Unit Head for Bristol Myers Squibb's (BMS) CAR T cell therapy franchise. At BMS, he was responsible for building core U.S. commercial capabilities and the successful launch execution of Breyanzi® and Abecma®. Prior to BMS, Mark was Vice President of Sales at Juno Therapeutics, a biotechnology company acquired by Celgene in 2018. Prior to Juno, Mark worked at Amgen for 15 years in a variety of U.S. and international commercial operations roles. His most recent role was General Manager of Amgen Czech Republic, where he led an enterprise of 11 commercialized therapies including launches of Kyprolis®, Blincyto®, and Repatha®. Mark is a registered pharmacist and received his Pharm.D. degree from the University of Illinois at Chicago. He completed a post-doctoral fellowship in health policy and economics at Thomas Jefferson University and earned M.B.A. degrees from both Columbia University and the University of California, Berkeley.

    "I am delighted to join Galera as the Company prepares for potential commercialization of its lead asset, avasopasem," commented Mark J. Bachleda, Pharm.D., M.B.A. "In only a few years, the Company has advanced avasopasem into a pivotal Phase 3 trial, which has the potential to become the new standard of care for severe oral mucositis in patients with head and neck cancer. I am eager to collaborate with the Galera management team as we dedicate our efforts to bringing this therapy to market and making it available for cancer patients in need."

    Previously, Jennifer served as Vice President, General Counsel, Secretary and Government Relations at The Wistar Institute, an independent international biomedical research institution. During her tenure, she drafted and negotiated license and equity agreements to launch six start-ups that helped advance Wistar technology. Prior to her role at Wistar, Jennifer was the Senior Vice President, General Counsel, Human Resources and Secretary for Antares Pharma, a publicly traded pharmaceuticals company. Before that, Jennifer was Executive Vice President, General Counsel, Human Resources and Secretary for Auxilium Pharmaceuticals, Inc., a publicly traded biopharmaceutical company acquired by Endo International plc. Jennifer earned her J.D. from the University of Pennsylvania Law School and her A.B. from Princeton University.

    "I am excited to partner with Galera's driven and dynamic management team to help advance the Company's novel dismutase mimetic product candidates through late-stage development," said Jennifer Evans Stacey, Esq. "Galera's assets have the potential to significantly improve quality of life for patients. I look forward to leading the Company's legal, compliance and human resources divisions during this significant time."

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (avasopasem, or GC4419), a selective small molecule dismutase mimetic in late-stage development to reduce the incidence and severity of radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. Avasopasem is also in development for radiotherapy-induced esophagitis in patients with lung cancer. Avasopasem has been granted FDA Fast Track and Breakthrough Therapy designations for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: expectations surrounding our growth and the continued advancement of our product pipeline; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates; plans for the commercial launch of avasopasem; and expected contributions from the newly hired executives. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com

     



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  3. Event to be webcast on Thursday, September 23 at 11:00 a.m. ET

    Phase 3 ROMAN trial of avasopasem manganese, Galera's lead candidate for SOM in patients with head and neck cancer, expected to read out in 4Q 2021

    MALVERN, Pa., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that the Company will host a virtual Key Opinion Leader event on radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer on Thursday, September 23 at 11:00 a.m. ET.

    Dr. Carryn Anderson, Clinical Associate Professor…

    Event to be webcast on Thursday, September 23 at 11:00 a.m. ET

    Phase 3 ROMAN trial of avasopasem manganese, Galera's lead candidate for SOM in patients with head and neck cancer, expected to read out in 4Q 2021

    MALVERN, Pa., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that the Company will host a virtual Key Opinion Leader event on radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer on Thursday, September 23 at 11:00 a.m. ET.

    Dr. Carryn Anderson, Clinical Associate Professor of Radiation Oncology at the University of Iowa, will provide a review of the current clinical treatment paradigm for patients with locally advanced head and neck cancer, including the use of intensity-modulated radiation therapy.

    Dr. Anderson's presentation will be followed by a video from a head and neck cancer survivor on his experience with SOM and a presentation from Galera's President and CEO, Mel Sorensen, M.D., with an overview of the SOM market in patients with head and neck cancer.

    The live audio webcast of the event will be accessible from the News & Events section of the Investors page of Galera's website at investors.galeratx.com. Individuals can participate in an interactive Q&A session by submitting questions via the webcast platform.

    An archived version of the webcast will be available for 30 days following the event.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (avasopasem, or GC4419), a selective small molecule dismutase mimetic in late-stage development to reduce the incidence and severity of radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. Avasopasem is also in development for radiotherapy-induced esophagitis in patients with lung cancer. Avasopasem has been granted FDA Fast Track and Breakthrough Therapy designations for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com 



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  4. Improvements observed in overall survival, progression-free survival, local tumor control, time to metastases, and tumor response rate

    Hazard ratios better than 0.5 on all survival and tumor outcome endpoints

    Combination with SBRT was well tolerated in the active and placebo arms

    Results reinforce rationale for GRECO-2, Galera's ongoing 160-patient Phase 2b pancreatic cancer trial

    MALVERN, Pa., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer, today announced final results from its Phase 1/2 pilot trial of its dismutase…

    Improvements observed in overall survival, progression-free survival, local tumor control, time to metastases, and tumor response rate

    Hazard ratios better than 0.5 on all survival and tumor outcome endpoints

    Combination with SBRT was well tolerated in the active and placebo arms

    Results reinforce rationale for GRECO-2, Galera's ongoing 160-patient Phase 2b pancreatic cancer trial

    MALVERN, Pa., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer, today announced final results from its Phase 1/2 pilot trial of its dismutase mimetic, GC4419, versus placebo, in patients with unresectable or borderline resectable locally advanced pancreatic cancer (LAPC), who are undergoing stereotactic body radiation therapy (SBRT). The results include a minimum of one year of follow up on all 42 patients enrolled in the trial.

    In this proof-of-concept trial, improvements were observed in overall survival (HR=0.48; 95% CI: 0.20-1.14; p=0.090), progression-free survival (HR=0.46; 95% CI: 0.22-0.98; p=0.040), local tumor control (HR=0.30; 95% CI: 0.08-1.10; p=0.055) and time to distant metastases (HR=0.39; 95% CI: 0.16-0.93; p=0.028). 46% of patients in the active arm were alive at last follow-up (11 out of 24) compared to 33% in the placebo arm (6 out of 18). As previously reported, 29% of patients in the active arm achieved a 30% or greater decrease in primary tumor size (partial response) compared to 11% of patients in the placebo arm. GC4419 was well tolerated, with similar rates of early and late adverse events in the active and placebo arms. For more information related to this trial, please see the Company's updated corporate presentation on the Investors page of Galera's website at investors.galeratx.com.

    "We are very pleased with the survival and tumor outcome benefits observed in the final analysis of this proof-of-concept trial," said Mel Sorensen, M.D., President and CEO of Galera. "The improvements across multiple efficacy parameters, together with the safety data, are encouraging and underpin the rationale for our 160-patient blinded, randomized GRECO-2 trial of GC4711 with SBRT in pancreatic cancer, where the primary endpoint is overall survival. These are exciting times for Galera as we also look forward to announcing topline data from our ROMAN Phase 3 trial for the reduction of severe oral mucositis in patients with head and neck cancer later this year."

    "We are excited to see the final results from this trial and enthusiastic to participate in the Phase 2b GRECO-2 trial," said Sarah Hoffe, M.D., Section Head of GI Radiation Oncology at H. Lee Moffitt Cancer Center and Research Institute. "These observed overall survival rates are particularly encouraging in pancreatic cancer, as this patient population faces a difficult diagnosis with high rates of distant metastasis and low rates of cure."

    Galera's selective dismutase mimetic product candidates are small molecules being developed to protect normal cells and sensitize cancer cells to radiotherapy. The Phase 1/2 pilot trial was a randomized, double-blind, multicenter, placebo-controlled trial in 42 patients diagnosed with LAPC evaluating the safety and efficacy of SBRT and the dismutase mimetic, GC4419, compared to SBRT and placebo. Patients were randomized (1:1) to receive GC4419 or placebo by intravenous infusion one hour prior to SBRT.

    GRECO-2 is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating Galera's second dismutase mimetic product candidate, GC4711, compared to placebo in patients with LAPC undergoing SBRT. The trial was initiated in May 2021 and is expected to enroll approximately 160 patients. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, local tumor control, time to distant metastases and surgical resection rate, in addition to safety.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (avasopasem, or GC4419), a selective small molecule dismutase mimetic in late-stage development to reduce the incidence and severity of radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. Avasopasem is also in development for radiotherapy-induced esophagitis in patients with lung cancer. Avasopasem has been granted FDA Fast Track and Breakthrough Therapy designations for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: expectations surrounding our growth and the continued advancement of our product pipeline; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates, including the interpretation of the safety and efficacy results from the Phase 1/2 LAPC pilot trial and whether such results underpin the rationale for the ongoing GRECO-2 trial; and plans and timing for the commencement of and the release of data from Galera's clinical trials. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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  5. MALVERN, Pa., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at three upcoming virtual investor conferences in September.

    Presentation Details:

    Event: H.C. Wainwright 23rd Annual Global Investment Conference
    Date: Monday, September 13, 2021
    Time: On-demand beginning at 7:00 a.m. ET

    Event: Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date: Tuesday, September 21, 2021
    Time: 11:35 a.m. ET

    Event: Cantor Fitzgerald Global…

    MALVERN, Pa., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at three upcoming virtual investor conferences in September.

    Presentation Details:

    Event: H.C. Wainwright 23rd Annual Global Investment Conference

    Date: Monday, September 13, 2021

    Time: On-demand beginning at 7:00 a.m. ET

    Event: Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Tuesday, September 21, 2021

    Time: 11:35 a.m. ET

    Event: Cantor Fitzgerald Global Healthcare Conference

    Date: Wednesday, September 29, 2021

    Time: 10:00 a.m. ET

    Live webcasts from the three presentations will be accessible from the Investors page of Galera's website, investors.galeratx.com. Following the events, archived webcasts will be available on the Galera website for 30 days.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (avasopasem, or GC4419), a selective small molecule dismutase mimetic in late-stage development to reduce the incidence and severity of radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. Avasopasem is also in development for radiotherapy-induced esophagitis in patients with lung cancer. Avasopasem has been granted FDA Fast Track and Breakthrough Therapy designations for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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