GRTX Galera Therapeutics Inc.

8.38
-0.38  -4%
Previous Close 8.76
Open 8.64
52 Week Low 5.87
52 Week High 15
Market Cap $211,629,626
Shares 25,254,132
Float 14,417,162
Enterprise Value $164,237,196
Volume 17,140
Av. Daily Volume 162,297
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Upcoming Catalysts

Drug Stage Catalyst Date
Avasopasem (GC4419)
COVID-19
Phase 2
Phase 2
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Avasopasem (GC4419) - ROMAN
Oral mucositis
Phase 3
Phase 3
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Avasopasem (GC4419)
Pancreatic cancer
Phase 1/2
Phase 1/2
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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) - (AESOP)
Esophagitis
Phase 2a
Phase 2a
Phase 2a top-line data due 1H 2022.
GC4711 (GRECO-2)
Pancreatic Cancer
Phase 2b
Phase 2b
Phase 2b initiation of dosing announced May 17, 2021.

Latest News

  1. Topline data expected in the second half of 2021

    Triggers $37.5M milestone payment from Blackstone Life Sciences

    MALVERN, Pa., June 28, 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 completion of enrollment in its pivotal Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. This achievement has triggered a $37.5 million milestone payment from funds managed by Blackstone…

    Topline data expected in the second half of 2021

    Triggers $37.5M milestone payment from Blackstone Life Sciences

    MALVERN, Pa., June 28, 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 completion of enrollment in its pivotal Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. This achievement has triggered a $37.5 million milestone payment from funds managed by Blackstone Life Sciences to Galera under the amended royalty agreement.

    "We are extremely pleased to announce completion of enrollment of the pivotal ROMAN trial, laying the groundwork for the potential regulatory approval and commercialization of avasopasem, our lead dismutase mimetic product candidate," said Mel Sorensen, M.D., Galera's President and CEO. "About 65% of patients diagnosed with HNC will receive standard-of-care chemoradiotherapy and approximately 70% of those patients will develop SOM. Radiation oncologists describe SOM — which can lead to the inability to eat and drink in addition to causing severe pain — as the most burdensome toxicity patients can face. With no approved product to treat SOM, we are eager to report results in the second half of 2021 for this potentially transformative therapy."

    The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients designed to evaluate the ability of avasopasem to reduce radiation-induced SOM in 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. The primary endpoint of the trial is the reduction in the incidence of SOM through the radiotherapy period. Secondary endpoints include the reduction in the severity of SOM and the number of days patients experience SOM.

    The FDA has granted Fast Track and Breakthrough Therapy Designation to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

    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

    Galera's lead product candidate is avasopasem manganese (avasopasem, or GC4419), 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). In addition to the ongoing pivotal Phase 3 ROMAN trial evaluating avasopasem in SOM patients with locally advanced HNC, the Company is conducting a Phase 2a trial of avasopasem assessing its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer as well as a Phase 1/2 trial assessing its anti-tumor effect when used in combination with stereotactic body radiation therapy in patients with locally advanced pancreatic cancer. The FDA has granted Fast Track and Breakthrough Therapy Designation 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 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, including plans for reporting topline data from the ROMAN trial in the second half of 2021, potential FDA regulatory approval and the commercial launch of avasopasem; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates, including whether avasopasem could be a potentially transformative therapy for the treatment of SOM; and expected payments from Blackstone, including the receipt of the $37.5 million triggered upon completion of enrollment of the ROMAN trial. 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 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

    William Windham

    Solebury Trout

    646-378-2946

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960



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  2. MALVERN, Pa., May 26, 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 the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 4:00 p.m. ET.

    A live webcast of the presentation will be accessible from the Investors page of Galera's website, investors.galeratx.com. An archived version of the webcast will be available in the News & Events section of the Investors page of Galera's website for 30 days following the event.

    About

    MALVERN, Pa., May 26, 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 the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 4:00 p.m. ET.

    A live webcast of the presentation will be accessible from the Investors page of Galera's website, investors.galeratx.com. An archived version of the webcast will be available in the News & Events section of the Investors page of Galera's website 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 (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of GC4419 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer and the GRECO-2 Phase 2b trial in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    William Windham

    Solebury Trout

    646-378-2946

    Media Contact:

    Zara Lockshin

    Solebury Trout

    330-417-6250



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  3. Initiation builds on positive overall survival and tumor control data from Phase 1/2 trial

    Triggers $20M milestone payment from Blackstone Life Sciences

    160-patient randomized, multicenter, placebo-controlled trial

    MALVERN, Pa., May 17, 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 first patient has been dosed in the randomized Phase 2b GRECO-2 trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). GC4711 is a selective small…

    Initiation builds on positive overall survival and tumor control data from Phase 1/2 trial

    Triggers $20M milestone payment from Blackstone Life Sciences

    160-patient randomized, multicenter, placebo-controlled trial

    MALVERN, Pa., May 17, 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 first patient has been dosed in the randomized Phase 2b GRECO-2 trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). GC4711 is a selective small molecule dismutase mimetic being developed to increase the anti-cancer effect of radiation. Enrollment of the first patient in this trial has triggered a $20 million milestone payment from funds managed by Blackstone Life Sciences to Galera under the amended royalty agreement.

    "We are excited to start this large Phase 2b trial in pancreatic cancer following the promising data from our initial trial in these patients, a placebo-controlled Phase 1/2 pilot trial, in which we saw a near doubling of overall survival in patients receiving a dismutase mimetic with SBRT," said Mel Sorensen, M.D., President and CEO of Galera. "In addition, the $20 million milestone payment from Blackstone ensures we are well capitalized to advance this trial in addition to our programs in lung cancer and radiation-induced severe oral mucositis as we prepare for the potential regulatory approval and commercialization of avasopasem, our lead dismutase mimetic product candidate."

    GRECO-2 is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating the effect of 100 mg of GC4711 or placebo in combination with SBRT on overall survival (OS), the trial's primary endpoint, in patients with LAPC. Secondary endpoints include progression-free survival (PFS), locoregional control (LRC), time to distant metastases (TDM) and surgical resection, in addition to safety. The trial is expected to enroll approximately 160 patients.

    "In the fight against pancreatic cancer, which has a 10% five-year survival rate and few treatment options, clinical trials are critical," said Julie Fleshman, J.D., MBA, President and CEO of the Pancreatic Cancer Action Network (PanCAN). "Galera's GRECO-2 study, as well as the other studies in our comprehensive database of pancreatic cancer clinical trials available in the U.S., investigates cutting edge research and has the potential to improve patient outcomes."

    Additional information on GRECO-2 can be found on clinicaltrials.gov using the identifier NCT04698915.

    About GC4711

    Galera's selective dismutase mimetic product candidates, GC4711 and GC4419, are small molecules being developed to protect normal cells and sensitize cancer cells to radiotherapy. GC4711 is in development specifically to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT). The molecule is currently being studied in a Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NCT04476797) and a Phase 2b trial in combination with SBRT in patients with locally advanced pancreatic cancer (NCT04698915).

    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 (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of GC4419 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer and the GRECO-2 Phase 2b trial in combination with SBRT in patients with LAPC. 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, including plans for the commercial launch of avasopasem; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates; and expected payments from Blackstone. 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 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

    William Windham

    Solebury Trout

    646-378-2946

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

     



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  4. Describes mechanism which sensitizes cancer cells to radiotherapy

    Supports recent results showing a near doubling of median overall survival observed in patients with pancreatic cancer by combining Galera's dismutase mimetic with radiation therapy

    MALVERN, Pa., May 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 that Science Translational Medicine has published a foundational preclinical article describing the synergy of avasopasem manganese, one of the Company's selective dismutase mimetics, with high fraction…

    Describes mechanism which sensitizes cancer cells to radiotherapy

    Supports recent results showing a near doubling of median overall survival observed in patients with pancreatic cancer by combining Galera's dismutase mimetic with radiation therapy

    MALVERN, Pa., May 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 that Science Translational Medicine has published a foundational preclinical article describing the synergy of avasopasem manganese, one of the Company's selective dismutase mimetics, with high fraction dose radiotherapy, such as stereotactic body radiation therapy (SBRT) or stereotactic ablative radiotherapy (SAbR), in killing tumors. The research, a collaboration between scientists at University of Texas Southwestern, University of Iowa and Galera, is part of the basis for two ongoing clinical trials with the Company's dismutase mimetics in combination with SBRT in pancreatic cancer and lung cancer. Galera recently reported clinical results from its placebo-controlled Phase 1/2 pilot trial, showing that the combination of its selective dismutase mimetic with SBRT nearly doubled the median overall survival of patients with locally advanced pancreatic cancer (LAPC).

    "We are gratified to have these results published in Science Translational Medicine describing the strong scientific rationale which underpin the promising clinical data seen in our pancreatic cancer trial," said Mel Sorensen, M.D., President and CEO of Galera. "We thank our research collaborators who have helped us lay out the novel scientific basis for this potentially groundbreaking therapy for patients."

    The publication, "Avasopasem manganese synergizes with hypofractionated radiation to ablate tumors through the generation of hydrogen peroxide," reports from preclinical cell and tumor models that the selective dismutase mimetic — by converting superoxide produced as a byproduct of radiotherapy into hydrogen peroxide — increased cancer cell killing with radiation. The synergy between the mimetic and radiotherapy increased with larger daily doses ("fractions") of radiation. Moreover, in the range of fraction sizes typical of SBRT, the combination ablated many of the tumors. In addition, as previously published, the authors report that by removing the superoxide, the dismutase mimetics protected normal cells from radiation toxicity. These two separate benefits of the dismutase mimetics with radiotherapy act through the differential responses to superoxide and hydrogen peroxide by normal cells and cancer cells and are at the core of Galera's clinical programs.

    Consistent with today's publication, Galera recently reported updated clinical results from a randomized, placebo-controlled Phase 1/2 pilot trial in which a near doubling of median overall survival was observed in patients with LAPC treated with a dismutase mimetic combined with SBRT versus placebo plus SBRT. Final results from this trial are expected in the second half of 2021. Building on the pilot trial, the Company expects to open the randomized Phase 2b GRECO-2 trial of GC4711, its second dismutase mimetic product candidate, in combination with SBRT in patients with LAPC in the first half of this year. Galera's Phase 1/2 GRECO-1 trial of GC4711 is ongoing, testing its dismutase mimetic in combination with SBRT for patients with non-small cell lung cancer.

    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 (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer. Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC. 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, including plans for the commercial launch of avasopasem; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates; 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 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

    William Windham

    Solebury Trout

    646-378-2946

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960



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  5. Phase 3 ROMAN trial in severe oral mucositis expected to complete enrollment in 1H21; topline data expected in 2H21

    Recently announced near doubling of median overall survival observed in placebo-controlled pancreatic cancer trial

    Phase 2b pancreatic cancer trial, GRECO-2, expected to commence enrollment in 1H21

    MALVERN, Pa., May 11, 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 financial results for the first quarter ended March 31, 2021, and highlighted recent corporate accomplishments.

    "Galera is off to a strong…

    Phase 3 ROMAN trial in severe oral mucositis expected to complete enrollment in 1H21; topline data expected in 2H21

    Recently announced near doubling of median overall survival observed in placebo-controlled pancreatic cancer trial

    Phase 2b pancreatic cancer trial, GRECO-2, expected to commence enrollment in 1H21

    MALVERN, Pa., May 11, 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 financial results for the first quarter ended March 31, 2021, and highlighted recent corporate accomplishments.

    "Galera is off to a strong start in 2021, as we continue to progress our clinical oncology programs in radiation-induced severe oral mucositis (SOM), locally advanced pancreatic cancer (LAPC) and non-small cell lung cancer (NSCLC) with our dismutase mimetics," said Mel Sorensen, M.D., President and CEO of Galera. "We recently reported updated data from our placebo-controlled Phase 1/2 pilot trial, in which a near doubling of median overall survival was observed in patients with pancreatic cancer. Building on the positive results from this trial, we anticipate initiating a Phase 2b trial in the first half of 2021 in patients with LAPC, with overall survival as the primary endpoint. Importantly, we look forward to announcing topline data in the pivotal Phase 3 trial in SOM and potential regulatory approval and commercialization of avasopasem, our lead dismutase mimetic product candidate."

    Recent Corporate Highlights

    Severe Oral Mucositis (SOM)

    • Continued enrollment in the pivotal Phase 3 ROMAN trial of avasopasem for the treatment of SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The Company remains on track to report topline data in the second half of 2021.



    • The Company expects to report topline data from the Phase 2a EUSOM multi-center trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy in the second half of 2021.

    Locally Advanced Pancreatic Cancer (LAPC)

    • Reported updated data from the placebo-controlled Phase 1/2 pilot trial of Galera's dismutase mimetic in patients with LAPC who are also undergoing stereotactic body radiation therapy (SBRT). As of the data analysis, median overall survival (OS) in the treatment arm (20.1 months) was nearly twice as long as observed in the placebo arm (10.9 months); 29% of patients in the treatment arm achieved a partial response compared to 11% of patients in the placebo arm; and positive results were also observed in local tumor control, time to metastases and progression-free survival. The Company expects to report final results from the trial with at least one year of follow-up on all patients in the second half of 2021.

    Non-Small Cell Lung Cancer (NSCLC)

    • Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711, Galera's second dismutase mimetic product candidate, in combination with SBRT in patients with NSCLC. The Company remains on track to report initial data in the first half of 2022.

    Esophagitis

    • Continued enrollment in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company expects to report topline data in the first half of 2022.

    First Quarter 2021 Financial Highlights

    • Research and development expenses were $12.4 million in the first quarter of 2021, compared to $14.3 million for the same period in 2020. The decrease was primarily attributable to avasopasem development costs, due to decreased expenses related to the ROMAN trial and a decrease in preclinical expenses.

       
    • General and administrative expenses were $5.1 million in the first quarter of 2021, compared to $3.6 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, and increased expenses related to pre-commercial activities for avasopasem.

       
    • Galera reported a net loss of $(18.7) million, or $(0.75) per share, for the first quarter of 2021, compared to a net loss of $(18.4) million, or $(0.74) per share, for the same period in 2020.



    • As of March 31, 2021, Galera had cash, cash equivalents and short-term investments of $57.5 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022. The Company expects to achieve these clinical enrollment milestones in the first half of 2021.

    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 (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer. Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC. 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, including plans for the commercial launch of avasopasem; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates; plans and timing for the commencement of and the release of data from Galera's clinical trials; expected payments from Blackstone; and the sufficiency of Galera's cash, cash equivalents and short-term investments. 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.





    Galera Therapeutics, Inc.
    Consolidated Statements of Operations
    (unaudited, in thousands except share and per share data)
        
     Three Months Ended March 31,
      2021   2020 
    Operating expenses:   
    Research and development$12,423  $14,252 
    General and administrative 5,058   3,566 
    Loss from operations (17,481)  (17,818)
    Other income (expense), net (1,234)  (599)
    Net loss$(18,715) $(18,417)
        
    Net loss per share of common stock, basic and diluted$(0.75) $(0.74)
    Weighed average common shares outstanding, basic and diluted 24,988,198   24,815,024 





    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)
        
     March 31, December 31,
     2021 2020
        
    Cash, cash equivalents, and short-term investments$57,520  $72,776
    Total assets 70,486   84,098
    Total current liabilities 15,855   13,968
    Total liabilities 81,059   77,980
    Total stockholders' equity (deficit) (10,573)  6,118



    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    William Windham

    Solebury Trout

    646-378-2946

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

     



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