GRTX Galera Therapeutics Inc.

10
-0.01  -0%
Previous Close 10.01
Open 9.95
52 Week Low 5.58
52 Week High 18.5733
Market Cap $249,513,520
Shares 24,951,352
Float 7,386,578
Enterprise Value $160,968,520
Volume 73,085
Av. Daily Volume 81,567
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Upcoming Catalysts

Drug Stage Catalyst Date
GC4419
COVID-19
Phase 2
Phase 2
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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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GC4711 (GRECO-1)
Non-Small Cell Lung Cancer (NSCLC)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
GC4711 (GRECO-2)
Pancreatic Cancer
Phase 2b
Phase 2b
Phase 2b trial to be initiated1H 2021.
GC4419
Esophagitis
Phase 2a
Phase 2a
Phase 2a dosing of first patient announced January 7, 2020.

Latest News

  1. MALVERN, Pa., Nov. 20, 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 a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020.

    The pre-recorded fireside chat can be accessed beginning November 23, 2020, from the Investors page of Galera's website, investors.galeratx.com, and will remain available for 60 days following the conference.

    About Galera Therapeutics

    Galera Therapeutics…

    MALVERN, Pa., Nov. 20, 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 a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020.

    The pre-recorded fireside chat can be accessed beginning November 23, 2020, from the Investors page of Galera's website, investors.galeratx.com, and will remain available for 60 days following the conference.

    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 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 has completed enrollment and reported interim 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 clinical trial in combination with SBRT in patients with non-small cell lung cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539



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  2. Presented Promising Interim Data from Placebo-controlled Pilot Dismutase Mimetic SBRT Combination Trial for Pancreatic Cancer

    Announced Planned Phase 2b GC4711 SBRT Combination Trial for Pancreatic Cancer (GRECO-2)

    Initiated Randomized Phase 1/2 GC4711 SBRT Combination Trial for NSCLC (GRECO-1)

    Remain on Track with Ongoing Phase 3 ROMAN Trial and Other Radiation-Induced Toxicity Trials of Avasopasem

    MALVERN, Pa., Nov. 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 third quarter ended…

    Presented Promising Interim Data from Placebo-controlled Pilot Dismutase Mimetic SBRT Combination Trial for Pancreatic Cancer

    Announced Planned Phase 2b GC4711 SBRT Combination Trial for Pancreatic Cancer (GRECO-2)

    Initiated Randomized Phase 1/2 GC4711 SBRT Combination Trial for NSCLC (GRECO-1)

    Remain on Track with Ongoing Phase 3 ROMAN Trial and Other Radiation-Induced Toxicity Trials of Avasopasem

    MALVERN, Pa., Nov. 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 third quarter ended September 30, 2020, and provided business updates.

    "We continue to make great strides advancing the clinical development of our small molecule superoxide dismutase mimetics' ability to address radiation toxicities and augment the anti-cancer efficacy of radiation," said Mel Sorensen, M.D., President and CEO of Galera. "We are delighted with the encouraging data from our placebo-controlled trial of GC4419 in combination with stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer (LAPC), which were presented during a late-breaker session at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting. The findings are the first clinical evidence supporting our extensive preclinical science that showed synergy of our dismutase mimetics with SBRT. In this first trial with the addition of a dismutase mimetic to SBRT in patients, we observed better tumor responses, saw more patients succeed in going to surgical resection, and are particularly pleased by the initial signal in survival. With these promising early activity results in hand, coupled with the preliminary safety findings of the combination, we look forward to continuing to advance the potential of our dismutase mimetics to enhance the anti-cancer efficacy of SBRT and improve outcomes for cancer patients. We have initiated the GRECO-1 Phase 1/2 trial of GC4711 with SBRT in non-small cell lung cancer (NSCLC), and also anticipate initiating a Phase 2b trial of GC4711 with SBRT in pancreatic cancer (GRECO-2) in the first half of 2021. Our most advanced program, the ROMAN Phase 3 trial, continues to enroll well and we look forward to reporting topline results in the second half of 2021."

    Third Quarter 2020 and Recent Corporate Highlights

    • In October, presented interim efficacy and safety data from the randomized, double-blind, multicenter, placebo-controlled pilot Phase 1/2 clinical trial of avasopasem manganese (GC4419) in combination with SBRT in patients with LAPC at ASTRO. In the analysis of the intent-to-treat population, multiple endpoints to date show a positive trend in favor of improved anti-cancer efficacy with avasopasem compared to placebo. While many of the patients are early in their follow-up post treatment, addition of the dismutase mimetic to SBRT appears to improve overall survival (OS) versus placebo (HR=0.4, 95% CI: 0.12-1.11; median OS not yet reached for avasopasem vs. 38.7 weeks for placebo; p=0.06). Best overall response within the SBRT field was partial response, according to modified RECIST criteria, or better in 33% of avasopasem patients versus 17% of placebo patients. Five patients in the avasopasem arm and two in the placebo arm were surgically resected. Among the resected avasopasem patients, all five achieved clear margins (R0), compared to only one of the two in the placebo arm. Progression-free survival hazard ratio as of the cut-off date also appears to favor the avasopasem arm (HR=0.6, 95% CI: 0.23-1.56; p=0.29). Toxicity was comparable across both treatment arms, with no significant differences in overall or Grade 3 GI toxicity post-SBRT. The data presented included all patients followed for a minimum of three months and 19 for more than one year, with data through August 24, 2020. The Company plans to provide an update on this trial with at least one year of follow-up on all patients in the second half of 2021.



    • In October, announced that the first patient had been dosed in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with central or large peripheral NSCLC tumors. GC4711 is Galera's second highly selective small molecule superoxide dismutase mimetic candidate and is being developed specifically for use in combination with SBRT. Following a safety run-in cohort, up to 66 NSCLC patients with locally advanced disease will receive GC4711 with SBRT or placebo with SBRT over five consecutive weekdays in a first stage of the randomized, double-blind, placebo-controlled Phase 2 portion of the GRECO-1 trial. A second stage is planned to add a checkpoint inhibitor to the SBRT combination. The GRECO-1 trial is supported in part by a recently awarded Small Business Innovation Research grant (4R44CA206795-02) from the National Cancer Institute of the National Institutes of Health. The Company anticipates reporting topline data from the first stage of this trial in the first half of 2022.



    • In October, hosted a virtual Key Opinion Leader (KOL) event featuring Sarah Hoffe, M.D., Section Head of GI Radiation Oncology and Senior Member at Moffitt Cancer Center. Dr. Hoffe provided an overview of the management of patients with localized pancreatic cancer, including the current clinical treatment paradigm and the use of SBRT.



    • In September, announced the first patient had been dosed in a pilot Phase 2 clinical trial of avasopasem to evaluate its ability to improve 28-day mortality in hospitalized patients who are critically ill with COVID-19. The Company anticipates reporting topline data from this trial in the first half of 2021.



    • Continued enrollment in multiple clinical trials of avasopasem for radiation-induced toxicities, including the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of severe oral mucositis induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), the Phase 2a EUSOM multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, as well as the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company remains on track to announce topline data from the ROMAN trial in the second half of 2021.

    Third Quarter 2020 Financial Highlights

    • Research and development expenses were $12.1 million in the third quarter of 2020, compared to $11.0 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. In addition, employee-related costs also increased due to increased headcount and share-based compensation expense. The increases were partially offset by decreased avasopasem preclinical spend and decreased GC4711 development expenses.



    • General and administrative expenses were $3.9 million in the third 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 $(17.1) million, or $(0.69) per share, for the third quarter of 2020, compared to a net loss of $(13.4) million, or $(51.43) per share, for the same period in 2019.



    • As of September 30, 2020, Galera had cash, cash equivalents and short-term investments of $89.2 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 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 has completed enrollment and reported interim 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 clinical trial in combination with SBRT in patients with non-small cell lung cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations surrounding our growth and the continued advancement of our product pipeline, the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates, plans 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 September 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 September 30, Nine Months Ended September 30,
     2020

     2019

     2020

     2019

    Operating expenses:       
    Research and development$12,133  $11,040  $40,225  $29,057 
    General and administrative 3,945   1,816   11,384   5,466 
    Loss from operations (16,078)  (12,856)  (51,609)  (34,523)
    Other income (expense), net (1,000)  (495)  (2,543)  (735)
    Net Loss (17,078)  (13,351)  (54,152)  (35,258)
    Accretion of redeemable convertible preferred stock to redemption value -   (2,108)  -   (6,178)
    Net loss attributable to common stockholders$(17,078) $(15,459) $(54,152) $(41,436)
            
    Net loss per share of common stock, basic and diluted$(0.69) $(51.43) $(2.18) $(137.85)
    Weighed average common shares outstanding, basic and diluted 24,874,805   300,597   24,840,822   300,597 
            



        
    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)
        
     September 30, December 31,
      2020  2019
        
    Cash, cash equivalents, and short-term investments$89,151 $112,290
    Total assets 98,075  123,376
    Total current liabilities 10,503  9,694
    Total liabilities 73,380  53,768
    Total stockholders' equity 24,695  69,608

     

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539



    Primary Logo

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  3. MALVERN, Pa., Nov. 03, 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 present at the 29th Annual Credit Suisse Virtual Healthcare Conference on Tuesday, November 10, 2020, at 11:45 a.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…

    MALVERN, Pa., Nov. 03, 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 present at the 29th Annual Credit Suisse Virtual Healthcare Conference on Tuesday, November 10, 2020, at 11:45 a.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 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 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 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 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 was completed. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second SOD mimetic product candidate, GC4711, is initially being developed to augment the anti-cancer efficacy of radiation and is currently being studied in a Phase 1/2 clinical trial in combination with SBRT in patients with non-small cell lung cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    Primary Logo

    View Full Article Hide Full Article
  4. Initial results from pilot Phase 1/2 clinical trial in patients with locally advanced pancreatic cancer presented during virtual ASTRO Annual Meeting

    First trial to evaluate anti-cancer activity of one of Galera's dismutase mimetics in combination with SBRT

    Management will host a live audio webcast at 4:30 p.m. EDT

    MALVERN, Pa., Oct. 27, 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 interim data from the full patient population (n=42) in its Phase 1/2 clinical trial of avasopasem manganese (GC4419) in…

    Initial results from pilot Phase 1/2 clinical trial in patients with locally advanced pancreatic cancer presented during virtual ASTRO Annual Meeting

    First trial to evaluate anti-cancer activity of one of Galera's dismutase mimetics in combination with SBRT

    Management will host a live audio webcast at 4:30 p.m. EDT

    MALVERN, Pa., Oct. 27, 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 interim data from the full patient population (n=42) in its Phase 1/2 clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). The data were presented today during the late-breaker special session of the 2020 American Society for Radiation Oncology (ASTRO) virtual Annual Meeting.

    GC4419 is an investigational, highly selective small molecule superoxide dismutase mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. The randomized, double-blind, multicenter, placebo-controlled pilot dose escalation Phase 1/2 trial was designed to evaluate the safety and efficacy of GC4419 in combination with SBRT, compared with SBRT and placebo, in patients with LAPC. The trial assessed safety and efficacy of SBRT when combined with GC4419 or placebo. After completion of induction chemotherapy, patients were randomized (1:1) to receive five-fraction SBRT and 90 mg of GC4419 or placebo control by intravenous infusion one hour prior to each SBRT fraction.

    In the interim analysis of the intent-to-treat population (n=42), median overall survival (OS) had not been reached at the data cutoff (date of August 24, 2020) in the GC4419 arm, compared to 38.7 weeks (HR=0.4; 95% CI: 0.12-1.11; p=0.06) in the placebo arm. Six-to-eight weeks post-SBRT, patients underwent protocol-specified evaluation for resection, and seven underwent resection. Of the patients in the GC4419 arm who were surgically resected (n=5), all achieved clear / negative margins (R0), one achieved pathological complete response (pCR) and four achieved pathological partial response (pPR), compared to one R0 and pPR of the two surgically resected patients in the placebo arm. No statistically significant differences in progression-free survival (PFS) were observed between GC4419 and placebo (HR=0.6; 95% CI: 0.23-1.56; p=0.29). However, patients were censored for PFS at the date of surgical resection or due to short interval follow up. Toxicity was comparable across both treatment arms, with no significant differences in acute (<90 days) or late (91-365 days) Grade 3+ toxicity post-SBRT.

    "The survival rate in pancreatic cancer is dismal. Our goals for treatment are to extend survival and improve the potential for surgical resection, as surgery remains the only potentially curative therapy for pancreatic cancer," said Sarah Hoffe, M.D., Section Head of GI Radiation Oncology and Senior Member at Moffitt Cancer Center, trial first author and investigator. "These interim data signal the potential of dismutase mimetics, when combined with SBRT, to prolong survival in patients with LAPC. Further study of dismutase mimetics to expand the utility of SBRT in pancreatic cancer treatment is warranted."

    The interim data includes all patients followed for a minimum of three months and 19 for more than one year, with data through August 24, 2020. The Company plans to provide an additional update on this trial with at least one year of follow up on all patients in the second half of 2021.

    "We're encouraged by the favorable overall survival benefit in this difficult-to-treat cancer observed in the interim data in this trial, which is the first trial evaluating the anti-cancer activity of one of Galera's dismutase mimetics in combination with SBRT," said Mel Sorensen, M.D., President and CEO of Galera. "Galera's dismutase mimetics are designed to improve radiation therapy by both increasing therapeutic anti-tumor efficacy at higher doses of radiation and by protecting normal cells, and we look forward to advancing the development of this potential combination therapy and expanding into other cancers to improve outcomes for patients undergoing radiotherapy for the treatment of cancer."

    The Company plans to leverage observations from this pilot trial to further develop GC4711, its second superoxide dismutase mimetic clinical candidate, specifically for use in combination with SBRT, and anticipates initiating a follow-on Phase 2 trial in pancreatic cancer with GC4711 in combination with SBRT in the first half of 2021. Galera recently announced it is also evaluating the anti-cancer activity of GC4711 in an ongoing Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NSCLC).

    The presentation is available for on-demand viewing for registered ASTRO attendees for the next 30 days.

    Conference Call

    Galera will host a live audio webcast at 4:30 p.m. EDT today 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 60 days following the event.

    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 locally advanced 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 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 safety findings for 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 events. 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 in a Phase 2 trial in hospitalized patients who are critically ill with COVID-19 (NCT04555096, available at clinicaltrials.gov); and a pilot Phase 1/2 trial (NCT03340974, available at clinicaltrials.gov) of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer was completed.

    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 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 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 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 was completed. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second SOD mimetic product candidate, GC4711, is initially being developed to augment the anti-cancer efficacy of radiation and is currently being studied in a Phase 1/2 clinical trial in combination with SBRT in patients with non-small cell lung 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 the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates, including with respect to the pilot Phase 1/2 clinical trial of GC4419 in combination with SBRT for LAPC and related data readouts, as well as the development of GC4711; and Galera's participation in upcoming events and presentations. 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; results of earlier studies and trials may not be predictive of future trial results; interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; 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 for which we have not yet received such designations; 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.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    Primary Logo

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  5. Interim data on first 19 patients released in ASTRO Annual Meeting late-breaker presentation abstract showed improvement in overall survival and multiple anti-cancer efficacy measures

    Interim data from full patient population to be presented during ASTRO Late-breaking Special Session October 27

    MALVERN, Pa., Oct. 23, 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 the release of the abstract containing interim data from the first 19 patients in its pilot Phase 1/2 clinical trial designed to evaluate the…

    Interim data on first 19 patients released in ASTRO Annual Meeting late-breaker presentation abstract showed improvement in overall survival and multiple anti-cancer efficacy measures

    Interim data from full patient population to be presented during ASTRO Late-breaking Special Session October 27

    MALVERN, Pa., Oct. 23, 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 the release of the abstract containing interim data from the first 19 patients in its pilot Phase 1/2 clinical trial designed to evaluate the safety and efficacy of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT), compared with SBRT and placebo, in patients with locally advanced pancreatic cancer (LAPC).

    The interim data were shared in abstract #LBA5 on the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting virtual program website. 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 based on positive results in multiple preclinical models.

    In the initial analysis of the intent-to-treat cohort (n=19) enrolled in the first, single-center stage of the trial, which comprises all patients followed for over a year, median overall survival (OS) had not yet been reached in the GC4419 arm, compared to 40.4 weeks (HR=0.3; 95% CI 0.09-1.05; p=0.046) in the placebo arm. The GC4419 arm also demonstrated favorable progression-free survival, locoregional control and time-to-distant metastases compared to the placebo arm. The incidence of acute (<90 days) or late (91-365 days) Grade 3+ toxicity post-SBRT was similar in both arms.

    "LAPC is a devastating diagnosis with limited treatment options. By combining our investigational dismutase mimetics with SBRT, we believe we have an opportunity to improve tumor response and survival outcomes. This is the first clinical data assessing the anti-cancer activity of one of our dismutase mimetics, and we are encouraged by this analysis of the initial cohort which suggests a meaningful survival benefit in pancreatic cancer," said Mel Sorensen, M.D., President and CEO of Galera. "We look forward to presenting the interim data from the full patient population in this pilot trial on October 27."

    The interim data from the full patient population (n=42) will be presented during the 2020 ASTRO Annual Meeting Late-breaking Special Session on October 27 beginning at 3 p.m. EDT. Galera will also host a management conference call and live audio webcast at 4:30 p.m. EDT on October 27.

    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 locally advanced 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 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 safety findings for 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 events. 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 in a Phase 2 trial in hospitalized patients who are critically ill with COVID-19 (NCT04555096, available at clinicaltrials.gov); and a pilot Phase 1/2 trial (NCT03340974, available at clinicaltrials.gov) of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer was completed.

    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 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 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 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 was completed. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second SOD mimetic product candidate, GC4711, is initially being developed to augment the anti-cancer efficacy of radiation and is currently being studied in a Phase 1/2 clinical trial in combination with SBRT in patients with non-small cell lung 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 the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates, including with respect to the pilot Phase 1/2 clinical trial of GC4419 in combination with SBRT for LAPC and related data readouts, as well as the development of GC4711; and Galera's participation in upcoming events and presentations. 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; results of earlier studies and trials may not be predictive of future trial results; interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; 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 for which we have not yet received such designations; 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.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    Primary Logo

    View Full Article Hide Full Article
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