GRTX Galera Therapeutics Inc.

7.93
+0.12  (+2%)
Previous Close 7.81
Open 8.03
52 Week Low 5.58
52 Week High 19.5
Market Cap $196,859,260
Shares 24,824,623
Float 7,259,849
Enterprise Value $77,086,999
Volume 2,309
Av. Daily Volume 87,875
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Upcoming Catalysts

Drug Stage Catalyst Date
GC4419
Pancreatic cancer
Phase 1/2
Phase 1/2
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GC4419 ROMAN
Oral mucositis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
GC4711
Non-Small Cell Lung Cancer (NSCLC)
Phase 1/2
Phase 1/2
Phase 1b/2a trial to be initiated 2H 2020.
GC4419
Esophagitis
Phase 2a
Phase 2a
Phase 2a dosing of first patient announced January 7, 2020.

Latest News

  1. Completed Enrollment of Randomized, Blinded, Placebo-controlled Trial of GC4419 in Combination with Radiotherapy in Locally Advanced Pancreatic Cancer; Topline Data Readout Expected in 2H20

    Phase 3 ROMAN Trial Remains on Track for Completion of Enrollment in 1H21

    MALVERN, Pa., Aug. 10, 2020 (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 second quarter ended June 30, 2020, and provided business updates.

    "During the second quarter, we continued to advance the development of our small molecule…

    Completed Enrollment of Randomized, Blinded, Placebo-controlled Trial of GC4419 in Combination with Radiotherapy in Locally Advanced Pancreatic Cancer; Topline Data Readout Expected in 2H20

    Phase 3 ROMAN Trial Remains on Track for Completion of Enrollment in 1H21

    MALVERN, Pa., Aug. 10, 2020 (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 second quarter ended June 30, 2020, and provided business updates.

    "During the second quarter, we continued to advance the development of our small molecule superoxide dismutase mimetics in clinical trials evaluating their ability to address radiation toxicities and augment the anti-cancer efficacy of radiation," said Mel Sorensen, M.D., President and CEO of Galera. "We were pleased to announce the completion of enrollment in our randomized, blinded, placebo-controlled, adaptive Phase 1b/2a trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer (LAPC). We expect to report topline data from that trial as well as initiate a Phase 1b/2a trial of GC4711 with SBRT in non-small cell lung cancer in the second half of this year. We also remain on track to complete enrollment of the Phase 3 ROMAN trial of avasopasem in the first half of next year and to report topline data from the ROMAN trial in the second half of 2021."

    Second Quarter 2020 and Recent Corporate Highlights

    • In July, announced the completion of patient enrollment in the randomized, blinded, placebo-controlled, adaptive Phase 1b/2a clinical trial of avasopasem in combination with SBRT in patients with LAPC. Topline data from this trial are expected in the second half of this year.

       
    • In June, dosed the first patient in a Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with head and neck cancer (HNC) undergoing standard-of-care radiotherapy.

       
    • Continued enrollment in the Phase 2a clinical trial of avasopasem to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer.

       
    • In May, presented new data at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, which demonstrated statistically significant reductions by avasopasem on markers of chronic kidney disease due to concurrent cisplatin chemoradiation in a retrospective analysis of the completed Phase 2b trial for the reduction of severe oral mucositis in patients with HNC. As a result, the assessment of these markers has been incorporated into the ROMAN Phase 3 trial.

       
    • In May, entered into an amendment to the royalty purchase agreement with Blackstone Life Sciences (Blackstone), which adds $37.5 million in additional funding to the existing $80 million royalty financing commitment that Blackstone (formerly Clarus Ventures) made in 2018. Under the updated agreement terms, Galera agreed to pay Blackstone up to a high single-digit percentage of future commercial royalties from the sales of avasopasem and GC4711 until the total royalty amount achieves an unchanged fixed single-digit multiple of the aggregate financing sum received, upon which the royalty terminates. As partial consideration for the amendment, Galera issued two warrants to Blackstone to purchase an aggregate of 550,661 shares of its common stock at an exercise price of $13.62 per share, each of which will become exercisable upon the receipt by Galera of the applicable specified milestone payment. 



    • In April, announced the appointment of Linda B. West to its Board of Directors. Ms. West most recently served as Vice President for DuPont Corporate Planning & Analyses, where she led the execution of transformational transactions.

    Second Quarter 2020 Financial Highlights

    • Research and development expenses were $13.8 million in the second quarter of 2020, compared to $9.5 million for the same period in 2019. The increase was primarily attributable to avasopasem development costs due to increased expenses in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a trial for the treatment of esophagitis in patients with lung cancer and the Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC, and costs associated with manufacturing scale-up activities. Employee-related costs also increased due to increased headcount and share-based compensation expense.

       
    • General and administrative expenses were $3.9 million in the second quarter of 2020, compared to $1.8 million for the same period in 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.

       
    • Galera reported a net loss of $(18.7) million, or $(0.75) per share, for the second quarter of 2020, compared to a net loss of $(11.6) million, or $(45.30) per share, for the same period in 2019.

       
    • As of June 30, 2020, Galera had cash, cash equivalents and short-term investments of $104.4 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.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is 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. Galera's lead product candidate is avasopasem manganese (GC4419), a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial for 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 a Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, a Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer and in a randomized Phase 1/2 trial in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, specifically for use in combination with SBRT, which successfully completed Phase 1 trials in healthy volunteers. 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, 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 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 Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC), Annual Report on Form 10-K for the year ended December 31, 2019 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 June 30, Six Months Ended June 30,
       2020   2019   2020   2019 
    Operating expenses:                
    Research and development $13,839  $9,515  $28,092  $18,017 
    General and administrative  3,874   1,756   7,439   3,650 
    Loss from operations  (17,713)  (11,271)  (35,531)  (21,667)
    Other income (expense), net  (944)  (287)  (1,543)  (240)
    Net Loss  (18,657)  (11,558)  (37,074)  (21,907)
    Accretion of redeemable convertible preferred stock to redemption value  -   (2,060)  -   (4,071)
    Net loss attributable to common stockholders $(18,657) $(13,618) $(37,074) $(25,978)
                     
    Net loss per share of common stock, basic and diluted $(0.75) $(45.30) $(1.49) $(86.42)
    Weighed average common shares outstanding, basic and diluted  24,832,264   300,597   24,823,644   300,597 
                     



    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)
        
     June 30, December 31,
     2020 2019
        
    Cash, cash equivalents, and short-term investments$104,409 $112,290
    Total assets 114,295  123,376
    Total current liabilities 12,402  9,694
    Total liabilities 74,058  53,768
    Total stockholders' equity 40,237  69,608
          

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    Primary Logo

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  2. MALVERN, Pa., July 30, 2020 (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 participate in an analyst-led fireside chat at the 2020 BTIG Virtual Biotechnology Conference on Monday, August 10, 2020, at 9:30 a.m. EDT.

    A live webcast of the event 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…

    MALVERN, Pa., July 30, 2020 (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 participate in an analyst-led fireside chat at the 2020 BTIG Virtual Biotechnology Conference on Monday, August 10, 2020, at 9:30 a.m. EDT.

    A live webcast of the event 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 therapeutics that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419), a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer, its lead indication. It is also being studied in a Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer and in a pilot Phase 1/2 trial in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, for SBRT which successfully completed Phase 1 trials in healthy volunteers. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

     

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

     

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

     

    Primary Logo

    View Full Article Hide Full Article
  3. MALVERN, Pa., July 13, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary small molecule therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has completed patient enrollment in its pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).

    Galera's investigational, highly selective small molecule superoxide dismutase (SOD) mimetics are designed to rapidly and selectively convert superoxide to hydrogen peroxide…

    MALVERN, Pa., July 13, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary small molecule therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has completed patient enrollment in its pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).

    Galera's investigational, highly selective small molecule superoxide dismutase (SOD) mimetics are designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. These dismutase mimetics have potential anti-cancer synergy supported by positive results in multiple preclinical models. The randomized Phase 1b/2a trial is evaluating the safety, progression-free survival and overall response rate of GC4419 in combination with SBRT, compared with SBRT and placebo, in LAPC patients. The trial is also assessing safety and tolerability to determine the recommended dose of SBRT when combined with GC4419 or placebo.

    "Pancreatic cancer has one of the poorest survival prognoses of common cancers and better treatments are urgently needed. Even when the disease is locally advanced, treatment options have limited impact on this difficult-to-treat cancer," said Mel Sorensen, M.D., President and CEO of Galera. "This pilot trial is the first to evaluate the anti-cancer effects of our dismutase mimetics in combination of SBRT in patients. We look forward to reporting topline data from this trial in the second half of 2020."

    Additional information on the trial can be found on clinicaltrials.gov using the identifier NCT03340974.

    About GC4419 (Avasopasem Manganese)

    Galera's lead product candidate, avasopasem manganese, is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic that is initially being developed for the reduction of radiation-induced severe oral mucositis (SOM) which is not yet approved. Avasopasem is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy.

    Avasopasem is currently being studied in the ROMAN trial, a randomized, double blind, placebo-controlled Phase 3 trial of approximately 450 patients (NCT03689712, available at clinicaltrials.gov) to investigate the effects of avasopasem on radiation-induced OM in patients with head and neck cancer. In Galera's 223-patient, double-blind, randomized, placebo-controlled Phase 2b trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem produced a statistically significant reduction in duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent) in the 90 mg treatment arm. Avasopasem also demonstrated clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg treatment arm. The overall adverse event profile of avasopasem in the Phase 2b trial was similar to that of placebo and consistent with the known adverse effects of chemoradiation, with reductions of blood cell counts, particularly low lymphocyte counts, the most prominent adverse effects. Adverse events considered attributable to avasopasem were limited to mild, transient postural light-headedness or decreased blood pressure. Patients were followed for two years after enrollment and showed no difference in tumor outcomes between active and control, consistent with expectations for combinations with intensity-modulated radiation therapy (IMRT)/cisplatin, suggesting that the efficacy of the chemoradiation therapy was not compromised.

    Avasopasem is also currently being studied in a Phase 2a trial for its potential to reduce the incidence of radiation-induced esophagitis in patients with lung cancer (NCT04225026, available at clinicaltrials.gov); and a pilot Phase 1/2 trial (NCT03340974, available at clinicaltrials.gov) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer.

    The U.S. Food and Drug Administration granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is 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. Galera's lead product candidate is avasopasem manganese (GC4419), a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer, its lead indication. It is also being studied in a Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer and in a pilot Phase 1/2 trial in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, for SBRT which successfully completed Phase 1 trials in healthy volunteers. 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 the potential, efficacy, and regulatory and clinical development of Galera's product candidates, and plans and timing for the release of data from 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC), Annual Report on Form 10-K for the year ended December 31, 2019 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

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

     

    Primary Logo

    View Full Article Hide Full Article
  4. MALVERN, Penn., May 29, 2020 (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 new data from a retrospective analysis of pre- and post-treatment markers of kidney function of patients treated with lead candidate avasopasem manganese in its Phase 2b trial for the reduction of chemoradiation-induced severe oral mucositis (SOM). The data are featured in an American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program poster presentation now available for on-demand viewing in ASCO's virtual program.

    Avasopasem is…

    MALVERN, Penn., May 29, 2020 (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 new data from a retrospective analysis of pre- and post-treatment markers of kidney function of patients treated with lead candidate avasopasem manganese in its Phase 2b trial for the reduction of chemoradiation-induced severe oral mucositis (SOM). The data are featured in an American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program poster presentation now available for on-demand viewing in ASCO's virtual program.

    Avasopasem is a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced toxicity severe oral mucositis (SOM). Galera's completed Phase 2b clinical trial evaluated avasopasem in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of concurrent radiation therapy and cisplatin, the current standard of care for head and neck cancer patients, plus either 30 mg or 90 mg of avasopasem or placebo.

    Each year in the United States, approximately 65,000 patients are diagnosed with head and neck cancer, according to the American Cancer Society, and nephrotoxicity from cisplatin-based chemotherapy occurs in up to 68 percent of head and neck cancer patients treated.

    The retrospective analysis evaluated changes in kidney function markers in a subset of 52 Phase 2b trial participants and 7 matched comparator patients who all received high dose (100 mg/m²) cisplatin once every three weeks. Post-treatment kidney function markers indicated patients who received 90 mg avasopasem had significantly less cisplatin-induced chronic kidney disease (CKD) compared to placebo.

    "Cisplatin, which is commonly used as part of the treatment regimen for patients with head and neck cancer, is associated with robust survival outcomes, but its use can be limited due to nephrotoxicity. There is a serious and unmet need for therapies to prevent or minimize kidney injury associated with cisplatin in order to sustain the survival benefit and ensure clinicians are able to optimize the clinical utility of chemotherapies, including platinum agents, for the up to 40 percent of head and neck cancer patients that develop a loco-regional recurrence," said Bryan Allen, M.D., Ph.D., Radiation Oncologist, University of Iowa Hospitals & Clinics. "The effect of avasopasem on markers of chronic kidney disease is an exciting preliminary finding and warrants continued study."

    Specifically, treatment with 90 mg avasopasem demonstrated statistically significant improvements (p<0.05) in return of kidney function to normal ranges after chemoradiotherapy, as measured by serum creatinine (sCr) levels between three and 24 months, estimated glomerular filtration rate (eGFR) between three and 24 months, and blood urea nitrogen (BUN) levels at three, six and 18 months, compared to placebo. A significant reduction (p<0.05) in the incidence of CKD at 12 months (GFR categories G3a-G5), compared to placebo, was also observed.

    "This new analysis demonstrating an improvement in markers of kidney function following cisplatin therapy further strengthens the body of evidence for the potential of avasopasem to be an important part of the treatment armamentarium for cancer," said Mel Sorensen, M.D., President and CEO of Galera. "We look forward to the continued evaluation of the potential of avasopasem in the reduction of chemoradiation-induced toxicities in our ongoing Phase 3 ROMAN trial for the treatment of SOM in head and neck cancer and our Phase 2a trial for the treatment of esophagitis in lung cancer."

    About Avasopasem Manganese (GC4419)

    Galera's lead product candidate, avasopasem manganese (GC4419), is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic that is initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem manganese is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy.

    Avasopasem manganese is currently being studied in the ROMAN trial, a randomized, double blind, placebo-controlled Phase 3 trial of approximately 450 patients (NCT03689712 available at clinicaltrials.gov) to investigate the effects of avasopasem manganese on radiation-induced OM in patients with head and neck cancer. In Galera's 223-patient, double-blind, randomized, placebo-controlled Phase 2b trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem manganese produced a statistically significant reduction in duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent) in the 90 mg treatment arm. Avasopasem manganese also demonstrated clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg treatment arm. No significant safety signals were observed, demonstrating avasopasem manganese was well tolerated when added to a standard radiotherapy regimen. The two-year tumor outcomes follow-up of patients enrolled in the trial were consistent with expectations for intensity-modulated radiation therapy (IMRT)/cisplatin alone suggesting that radiation efficacy was maintained.

    Avasopasem manganese is also currently being studied in a Phase 2a trial for its potential to reduce the incidence of radiation-induced esophagitis in patients with lung cancer (NCT04225026 available at clinicaltrials.gov), as well as in a pilot Phase 1/2 trial (NCT03340974 available at clinicaltrials.gov) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer.

    The U.S. Food and Drug Administration granted Fast Track and Breakthrough Therapy designations to avasopasem manganese for the reduction of SOM induced by radiotherapy.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is 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. Galera's lead product candidate is avasopasem manganese (GC4419), a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem manganese is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer, its lead indication, and in the Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem manganese for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, which successfully completed Phase 1 trials in healthy volunteers. 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 our beliefs about clinical data, and the potential, efficacy, and regulatory and clinical development of Galera's product candidates. 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC), Annual Report on Form 10-K for the year ended December 31, 2019 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

    Jennifer Porcelli
    Solebury Trout
    646-378-2962
     

    Media Contact:
    Gina Cestari
    6 Degrees
    917-797-7904

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  5. MALVERN, Pa., May 18, 2020 (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, announced today that it will host a virtual Key Opinion Leader (KOL) event on cisplatin-induced chronic kidney disease on Friday, May 22, 2020, from 10 a.m. to 11 a.m. EDT.

    The event will feature a panel discussion regarding the clinical challenges of nephrotoxicity of platinum-based chemotherapy (cisplatin) in the treatment of patients with head and neck cancer, and a summary of the preliminary findings from a retrospective analysis of Phase 2b trial data in patients…

    MALVERN, Pa., May 18, 2020 (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, announced today that it will host a virtual Key Opinion Leader (KOL) event on cisplatin-induced chronic kidney disease on Friday, May 22, 2020, from 10 a.m. to 11 a.m. EDT.

    The event will feature a panel discussion regarding the clinical challenges of nephrotoxicity of platinum-based chemotherapy (cisplatin) in the treatment of patients with head and neck cancer, and a summary of the preliminary findings from a retrospective analysis of Phase 2b trial data in patients with head and neck cancer and the potential role of avasopasem manganese (GC4419) in this patient population.

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

    An archived version of the webcast will be available in the News & Events section of the Investors page of Galera's website for 60 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 therapeutics that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419), a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem manganese is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer, its lead indication, and in the Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem manganese for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, which successfully completed Phase 1 trials in healthy volunteers. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:
    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500

    Chiara Russo
    Solebury Trout
    617-221-9197

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
     

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