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

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

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

    Dr. Carryn Anderson, Clinical Associate Professor…

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

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

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

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

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

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

    An archived version of the webcast will be available for 30 days following the event.

    About Galera Therapeutics

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

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com 



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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    About Galera Therapeutics

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

    Forward-Looking Statements

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

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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

    Presentation Details:

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

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

    Event: Cantor Fitzgerald Global…

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

    Presentation Details:

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

    Date: Monday, September 13, 2021

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

    Event: Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Tuesday, September 21, 2021

    Time: 11:35 a.m. ET

    Event: Cantor Fitzgerald Global Healthcare Conference

    Date: Wednesday, September 29, 2021

    Time: 10:00 a.m. ET

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

    About Galera Therapeutics

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

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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  4. Completed enrollment in pivotal Phase 3 ROMAN trial for severe oral mucositis (SOM) in patients with head and neck cancer; topline data expected in Q4 2021

    Announced near doubling in median overall survival observed in interim analysis of 42-patient placebo-controlled pancreatic cancer trial; final results expected in Q3 2021

    Initiated 160-patient placebo-controlled GRECO-2 pancreatic cancer trial

    Clinical programs triggered two milestone payments from Blackstone Life Sciences

    MALVERN, Pa., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy…

    Completed enrollment in pivotal Phase 3 ROMAN trial for severe oral mucositis (SOM) in patients with head and neck cancer; topline data expected in Q4 2021

    Announced near doubling in median overall survival observed in interim analysis of 42-patient placebo-controlled pancreatic cancer trial; final results expected in Q3 2021

    Initiated 160-patient placebo-controlled GRECO-2 pancreatic cancer trial

    Clinical programs triggered two milestone payments from Blackstone Life Sciences

    MALVERN, Pa., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the second quarter ended June 30, 2021, and highlighted recent corporate accomplishments.

    "We had a highly productive quarter in the clinic, including completion of enrollment in our 455-patient pivotal Phase 3 ROMAN trial of our lead product candidate, avasopasem, for SOM in patients with head and neck cancer, promising tumor outcome and survival data in an interim analysis of our 42-patient pancreatic cancer trial, and initiation of our 160-patient double-blinded placebo-controlled GRECO-2 pancreatic cancer trial," said Mel Sorensen, M.D., President and CEO. "We look forward to reporting clinical trial results from our key programs later this year. In parallel, Galera continues to strengthen our cash position and build our commercial capabilities as we work toward potential FDA approval of avasopasem in radiotherapy-induced SOM."

    Recent Corporate Highlights

    Severe Oral Mucositis (SOM)

    • Completed enrollment in the pivotal Phase 3 ROMAN trial of avasopasem for SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy, which triggered a $37.5 million milestone payment from funds managed by Blackstone Life Sciences (Blackstone) received in July 2021. The Company expects to report topline data in the fourth quarter of 2021.



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

    Locally Advanced Pancreatic Cancer (LAPC)

    • Reported updated data from the placebo-controlled 42-patient trial of Galera's dismutase mimetic in patients with LAPC who are undergoing stereotactic body radiation therapy (SBRT). The updated results include a minimum follow-up of six months on all 42 patients. As of the interim data analysis, median overall survival in the treatment arm (20.1 months) was nearly twice as long as observed in the placebo arm (10.9 months); and positive results were also observed in local tumor control, time to metastases and progression-free survival. The Company expects to report final results from the trial, with at least one year of follow-up on all patients, in the third quarter of 2021.



    • Initiated the 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of GC4711, Galera's second dismutase mimetic product candidate, in combination with SBRT in patients with LAPC in May 2021, which triggered a $20 million milestone payment from Blackstone received in June 2021.

    Non-Small Cell Lung Cancer (NSCLC)

    • Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.

    Esophagitis

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

    Second Quarter 2021 Financial Highlights

    • Research and development expenses were $16.0 million in the second quarter of 2021, compared to $13.8 million for the same period in 2020. The increase was primarily attributable to avasopasem development costs due to increased clinical expenses, primarily related to the ROMAN trial, and an increase in manufacturing and regulatory activities.



    • General and administrative expenses were $5.1 million in the second quarter of 2021, compared to $3.9 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to pre-commercial activities for avasopasem, and increased insurance expense and professional fees.



    • Galera reported a net loss of $(22.4) million, or $(0.88) per share, for the second quarter of 2021, compared to a net loss of $(18.7) million, or $(0.75) per share, for the same period in 2020.



    • As of June 30, 2021, Galera had cash, cash equivalents and short-term investments of $66.5 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the payment from Blackstone in the amount of $37.5 million received in July 2021, will enable Galera to fund its operating expenses and capital expenditure requirements for at least the next twelve months.

    About Galera Therapeutics

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

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: expectations surrounding our growth and the continued advancement of our product pipeline, including the potential, safety, efficacy, clinical development and regulatory approval of Galera's product candidates, including with respect to the updated results from the LAPC pilot trial; plans and timing for the commencement of and the release of data from Galera's clinical trials, including with respect to the Phase 3 ROMAN trial, the Phase 2a EUSOM trial, and the LAPC pilot trial, among others; plans for the commercial launch of avasopasem; 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 or otherwise completing clinical trials; the FDA's acceptance of data from clinical trials conducted outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

            
            
    Galera Therapeutics, Inc.
    Consolidated Statements of Operations
    (unaudited, in thousands except share and per share data)
            
     Three Months Ended June 30, Six Months Ended June 30,
      2021  2020  2021  2020
    Operating expenses:       
    Research and development$15,966  $13,839  $28,389  $28,092 
    General and administrative 5,122   3,874   10,180   7,439 
    Loss from operations (21,088)  (17,713)  (38,569)  (35,531)
    Other income (expense), net (1,298)  (944)  (2,532)  (1,543)
    Net loss$(22,386) $(18,657) $(41,101) $(37,074)
            
    Net loss per share of common stock, basic and diluted$(0.88) $(0.75) $(1.63) $(1.49)
    Weighted average common shares outstanding, basic and diluted 25,401,046   24,832,264   25,195,763   24,823,644 
            





    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)
        
     June 30, December 31,
      2021  2020

        
    Cash, cash equivalents, and short-term investments$66,527  $72,776 
    Total assets 115,269   84,098 
    Total current liabilities 16,843   13,968 
    Total liabilities 140,786   77,980 
    Total stockholders' equity (deficit) (25,517)  6,118 
        

     

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    330-417-6250

    zlockshin@soleburytrout.com

     



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  5. Topline data expected in the second half of 2021

    Triggers $37.5M milestone payment from Blackstone Life Sciences

    MALVERN, Pa., June 28, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced completion of enrollment in its pivotal Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. This achievement has triggered a $37.5 million milestone payment from funds managed by Blackstone…

    Topline data expected in the second half of 2021

    Triggers $37.5M milestone payment from Blackstone Life Sciences

    MALVERN, Pa., June 28, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced completion of enrollment in its pivotal Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. This achievement has triggered a $37.5 million milestone payment from funds managed by Blackstone Life Sciences to Galera under the amended royalty agreement.

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

    The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients designed to evaluate the ability of avasopasem to reduce radiation-induced SOM in patients with locally advanced HNC, receiving seven weeks of standard-of-care radiotherapy plus cisplatin. Patients were randomized to one of the two treatment groups (3:2) to receive 90 mg of avasopasem or placebo by infusion on the days they receive their radiation treatment. The primary endpoint of the trial is the reduction in the incidence of SOM through the radiotherapy period. Secondary endpoints include the reduction in the severity of SOM and the number of days patients experience SOM.

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

    About Oral Mucositis

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

    About Avasopasem

    Galera's lead product candidate is avasopasem manganese (avasopasem, or GC4419), a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC). In addition to the ongoing pivotal Phase 3 ROMAN trial evaluating avasopasem in SOM patients with locally advanced HNC, the Company is conducting a Phase 2a trial of avasopasem assessing its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer as well as a Phase 1/2 trial assessing its anti-tumor effect when used in combination with stereotactic body radiation therapy in patients with locally advanced pancreatic cancer. The FDA has granted Fast Track and Breakthrough Therapy Designation to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

    About the Phase 3 ROMAN Trial

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

    About Galera Therapeutics

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

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: expectations surrounding our growth and the continued advancement of our product pipeline, including plans for reporting topline data from the ROMAN trial in the second half of 2021, potential FDA regulatory approval and the commercial launch of avasopasem; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates, including whether avasopasem could be a potentially transformative therapy for the treatment of SOM; and expected payments from Blackstone, including the receipt of the $37.5 million triggered upon completion of enrollment of the ROMAN trial. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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  6. MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 4:00 p.m. ET.

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

    About

    MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 4:00 p.m. ET.

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

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of GC4419 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer and the GRECO-2 Phase 2b trial in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    330-417-6250

    zlockshin@soleburytrout.com



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

    Triggers $20M milestone payment from Blackstone Life Sciences

    160-patient randomized, multicenter, placebo-controlled trial

    MALVERN, Pa., May 17, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the first patient has been dosed in the randomized Phase 2b GRECO-2 trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). GC4711 is a selective small…

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

    Triggers $20M milestone payment from Blackstone Life Sciences

    160-patient randomized, multicenter, placebo-controlled trial

    MALVERN, Pa., May 17, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the first patient has been dosed in the randomized Phase 2b GRECO-2 trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). GC4711 is a selective small molecule dismutase mimetic being developed to increase the anti-cancer effect of radiation. Enrollment of the first patient in this trial has triggered a $20 million milestone payment from funds managed by Blackstone Life Sciences to Galera under the amended royalty agreement.

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

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

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

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

    About GC4711

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

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of GC4419 in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer and the GRECO-2 Phase 2b trial in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

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

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com 



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  8. Describes mechanism which sensitizes cancer cells to radiotherapy

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

    MALVERN, Pa., May 12, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Science Translational Medicine has published a foundational preclinical article describing the synergy of avasopasem manganese, one of the Company's selective dismutase mimetics, with high fraction…

    Describes mechanism which sensitizes cancer cells to radiotherapy

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

    MALVERN, Pa., May 12, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Science Translational Medicine has published a foundational preclinical article describing the synergy of avasopasem manganese, one of the Company's selective dismutase mimetics, with high fraction dose radiotherapy, such as stereotactic body radiation therapy (SBRT) or stereotactic ablative radiotherapy (SAbR), in killing tumors. The research, a collaboration between scientists at University of Texas Southwestern, University of Iowa and Galera, is part of the basis for two ongoing clinical trials with the Company's dismutase mimetics in combination with SBRT in pancreatic cancer and lung cancer. Galera recently reported clinical results from its placebo-controlled Phase 1/2 pilot trial, showing that the combination of its selective dismutase mimetic with SBRT nearly doubled the median overall survival of patients with locally advanced pancreatic cancer (LAPC).

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

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

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

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer. Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

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

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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

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

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

    MALVERN, Pa., May 11, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the first quarter ended March 31, 2021, and highlighted recent corporate accomplishments.

    "Galera is off to a strong…

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

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

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

    MALVERN, Pa., May 11, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the first quarter ended March 31, 2021, and highlighted recent corporate accomplishments.

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

    Recent Corporate Highlights

    Severe Oral Mucositis (SOM)

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



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

    Locally Advanced Pancreatic Cancer (LAPC)

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

    Non-Small Cell Lung Cancer (NSCLC)

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

    Esophagitis

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

    First Quarter 2021 Financial Highlights

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

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

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



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

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported updated results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer. Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

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





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





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



    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com

     



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  10. MALVERN, Pa., May 05, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at a fireside chat at the BofA Securities 2021 Virtual Healthcare Conference on Wednesday, May 12, 2021, at 8:45 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…

    MALVERN, Pa., May 05, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at a fireside chat at the BofA Securities 2021 Virtual Healthcare Conference on Wednesday, May 12, 2021, at 8:45 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, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer. Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    William Windham

    Solebury Trout

    646-378-2946

    wwindham@soleburytrout.com  

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com



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  11. Near double the median overall survival observed in patients receiving Galera's dismutase mimetic + SBRT versus placebo + SBRT, showing strong therapeutic potential

    Improvements versus placebo also observed in local tumor control, time to metastases and progression-free survival

    Data support Company's 160 patient Phase 2b pancreatic cancer trial, GRECO-2

    MALVERN, Pa., April 28, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer, today announced updated results from its Phase 1/2 pilot trial of GC4419, versus placebo, in patients…

    Near double the median overall survival observed in patients receiving Galera's dismutase mimetic + SBRT versus placebo + SBRT, showing strong therapeutic potential

    Improvements versus placebo also observed in local tumor control, time to metastases and progression-free survival

    Data support Company's 160 patient Phase 2b pancreatic cancer trial, GRECO-2

    MALVERN, Pa., April 28, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer, today announced updated results from its Phase 1/2 pilot trial of GC4419, versus placebo, in patients with locally advanced pancreatic cancer (LAPC) who are undergoing stereotactic body radiation therapy (SBRT). The updated results, as of this data analysis, include a minimum follow up of six months on all 42 patients and were consistent with the positive results reported with a minimum follow up of three months. The Company plans to report final results from the trial after a minimum of one year of follow up, expected during the second half of 2021.

    "The data from this trial continue to impress, showing consistent and durable benefits across multiple measures, including the most important for the patient, overall survival," said Mel Sorensen, M.D., President and CEO of Galera. "These encouraging results informed the design of our Phase 2b GRECO-2 trial and underscore our excitement about the potential to make a meaningful difference for patients with this tough diagnosis."

    As of this data analysis, median overall survival in the treatment arm was nearly twice as long as observed in the placebo arm, 20.1 months compared to 10.9 months, respectively. 29% of patients in the treatment arm achieved a 30% or greater response (partial response) compared to 11% of patients in the placebo arm. Positive results were also observed in local tumor control, time to metastases and progression-free survival. As previously reported, GC4419 was well tolerated as of this data analysis, with similar rates of adverse events in the treatment and placebo arms.

    "There are limited treatment options for patients with locally advanced pancreatic cancer and we are continually looking for innovative approaches," said Sarah Hoffe, M.D., Section Head of GI Radiation Oncology at H. Lee Moffitt Cancer Center and Research Institute. "These pancreatic data are exciting and speak to the potential emergence of an entirely novel class of cancer therapeutics for patients."

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

    The data from this trial support GRECO-2, a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate GC4711, Galera's second dismutase mimetic product candidate, combined with SBRT in patients with LAPC. The primary endpoint of the Phase 2b trial is overall survival. The Company expects to initiate patient dosing in GRECO-2 in the first half of 2021, and the trial is expected to enroll approximately 160 patients.

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), a selective small molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), its lead indication. It is also being studied in the EUSOM Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer, and a Phase 2 trial in hospitalized patients who are critically ill with COVID-19. A pilot Phase 1/2 trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC) has completed enrollment and reported results, with follow-up ongoing. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera's second dismutase mimetic product candidate, GC4711, is being developed specifically to augment the anti-cancer efficacy of SBRT, and is currently being studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer. Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

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

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Zara Lockshin

    Solebury Trout

    646-378-2960

    zlockshin@soleburytrout.com 



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  12. Pivotal Phase 3 ROMAN Trial in Severe Oral Mucositis on Track for Completion of Enrollment in 1H21; Topline Data Readout in 2H21

    Anticipate Final Data Readout from Locally Advanced Pancreatic Cancer (LAPC) Pilot Trial in 2H21

    On Track for Initiation of Phase 2b GRECO-2 Trial of GC4711 in Combination with Stereotactic Body Radiation Therapy (SBRT) for LAPC in 1H21

    MALVERN, Pa., March 11, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the fourth quarter and year ended December 31…

    Pivotal Phase 3 ROMAN Trial in Severe Oral Mucositis on Track for Completion of Enrollment in 1H21; Topline Data Readout in 2H21

    Anticipate Final Data Readout from Locally Advanced Pancreatic Cancer (LAPC) Pilot Trial in 2H21

    On Track for Initiation of Phase 2b GRECO-2 Trial of GC4711 in Combination with Stereotactic Body Radiation Therapy (SBRT) for LAPC in 1H21

    MALVERN, Pa., March 11, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the fourth quarter and year ended December 31, 2020, and highlighted recent corporate accomplishments.

    "In 2020, Galera presented positive interim data demonstrating that our dismutase mimetics have the potential to benefit the anti-cancer side of the therapeutic index of radiotherapy," said Mel Sorensen, M.D., President and CEO of Galera. "This encouraging interim data from our pilot placebo-controlled Phase 1/2 trial in patients with pancreatic cancer was presented at ASTRO in late 2020. We look forward to providing the final data readout from this trial in the second half of 2021 and advancing this regimen with the initiation of our Phase 2b GRECO-2 trial of GC4711 in combination with SBRT in patients with LAPC in the first half of 2021."

    Dr. Sorensen continued, "We are excited for the year ahead, which we believe will be transformative for our company, with the topline data readout of our Phase 3 ROMAN trial. In anticipation, we continue our preparations for the commercial launch of avasopasem manganese."

    Recent Corporate Highlights

    Severe Oral Mucositis (SOM)

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

    • Completed enrollment in the Phase 2a EUSOM multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy. The Company remains on track to report topline data in the second half of 2021.

    Locally Advanced Pancreatic Cancer (LAPC)

    • Presented positive interim data from the pilot placebo-controlled Phase 1/2 anti-cancer trial of avasopasem in combination with SBRT in patients with LAPC at the American Society for Radiation Oncology (ASTRO) virtual Annual Meeting in late 2020. Data on all patients through a minimum follow-up of three months demonstrated better tumor outcomes, including overall survival, with avasopasem compared to placebo. The Company plans to provide final data from this trial with at least one year of follow-up data on all patients in the second half of 2021.

    • Remain on track to initiate the Phase 2b GRECO-2 trial of GC4711, Galera's second superoxide dismutase mimetic candidate, in combination with SBRT in patients with LAPC in the first half of 2021. GRECO-2 is a randomized, double-blind, placebo-controlled trial to evaluate the effect of 100 mg of GC4711 versus placebo in combination with SBRT on overall survival in patients with LAPC. The trial is expected to enroll approximately 160 patients.

    Non-Small Cell Lung Cancer (NSCLC)

    • Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with NSCLC. The Phase 2 portion of GRECO-1 is randomized, double-blind, and placebo-controlled to evaluate the effect of 100 mg of GC4711 versus placebo. The Company continues to expect to report initial data in the first half of 2022.

    Esophagitis

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

    Fourth Quarter 2020 Financial Highlights

    • Research and development expenses were $14.6 million in the fourth quarter of 2020, compared to $13.3 million for the same period in 2019. The increase was primarily attributable to avasopasem and GC4711 development costs, as well as higher employee-related costs due to increased headcount and share-based compensation expense. The increases were partially offset by decreased avasopasem and GC4711 preclinical spend.

       
    • General and administrative expenses were $4.3 million in the fourth quarter of 2020, compared to $2.9 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 $(20.1) million, or $(0.80) per share, for the fourth quarter of 2020, compared to a net loss of $(16.7) million, or $(1.31) per share, for the same period in 2019.



    • As of December 31, 2020, Galera had cash, cash equivalents and short-term investments of $72.8 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. We expect to achieve these clinical enrollment milestones in the first half of 2021.

    Full Year 2020 Financial Highlights

    • Research and development expenses were $54.8 million for the year ended December 31, 2020, compared to $42.3 million for the year ended December 31, 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 AESOP trial and the Phase 2a EUSOM trial, and manufacturing scale-up activities. In addition, employee-related costs also increased due to increased headcount and share-based compensation expense.

    • General and administrative expenses were $15.7 million for the year ended December 31, 2020, compared to $8.4 million for the year ended December 31, 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 $(74.2) million, or $(2.98) per share, for the year ended December 31, 2020, compared to a net loss of $(51.9) million, or $(16.31) per share, for the year ended December 31, 2019.

    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, also referred to as avasopasem), 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 (LAPC) 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 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, including plans for the commercial launch of avasopasem; the potential, safety, efficacy, and regulatory and clinical development of Galera's product candidates; plans and timing for the commencement of and the release of data from Galera's clinical trials; expected payments from Blackstone; and the sufficiency of Galera's cash, cash equivalents and short-term investments. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.





    Galera Therapeutics, Inc.
    Consolidated Statements of Operations
    (in thousands, except share and per share data)
            
     Three Months Ended December 31, Year Ended December 31,
      2020   2019   2020   2019 
    Operating expenses:       
    Research and development$14,620  $13,276  $54,845  $42,333 
    General and administrative 4,323   2,892   15,708   8,358 
    Loss from operations (18,943)  (16,168)  (70,553)  (50,691)
    Other income (expense), net (1,138)  (513)  (3,681)  (1,248)
    Loss before income tax benefit (20,081)  (16,681)  (74,234)  (51,939)
    Income tax benefit 16   9   16   9 
    Net loss (20,065)  (16,672)  (74,218)  (51,930)
    Accretion of redeemable convertible preferred stock to redemption value -   (998)  -   (7,176)
    Net loss attributable to common stockholders$(20,065) $(17,670) $(74,218) $(59,106)
            
    Net loss per share of common stock, basic and diluted$(0.80) $(1.31) $(2.98) $(16.31)
    Weighed average common shares outstanding, basic and diluted 24,955,986   13,489,826   24,869,770   3,625,005 
            





    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (in thousands)
        
     December 31,
      2020   2019 
        
    Cash, cash equivalents, and short-term investments$72,776  $112,290 
    Total assets 84,098   123,376 
    Total current liabilities 13,968   9,694 
    Total liabilities 77,980   53,768 
    Total stockholders' equity 6,118   69,608 



    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com



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  13. MALVERN, Pa., March 10, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021, at 1:50 p.m. ET.

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

    MALVERN, Pa., March 10, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021, at 1:50 p.m. ET.

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

    About Galera Therapeutics

    Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer. Galera's lead product candidate is avasopasem manganese (GC4419, also referred to as avasopasem), 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 (LAPC) 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 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com 



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  14. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com



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  15. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

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  16. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

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  17. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  18. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  19. MALVERN, Pa., Oct. 22, 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 the first patient has been dosed in the Phase 1/2 GRECO-1 clinical trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC).

    GC4711, Galera's second clinical candidate, is a highly selective small molecule superoxide dismutase (SOD) mimetic that is designed to rapidly convert superoxide to hydrogen peroxide and is being developed specifically for use in combination with…

    MALVERN, Pa., Oct. 22, 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 the first patient has been dosed in the Phase 1/2 GRECO-1 clinical trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC).

    GC4711, Galera's second clinical candidate, is a highly selective small molecule superoxide dismutase (SOD) mimetic that is designed to rapidly convert superoxide to hydrogen peroxide and is being developed specifically for use in combination with SBRT. In preclinical studies, GC4711, when added to an SBRT regimen, increased the anti-cancer efficacy of radiotherapy and protected normal lung tissue.

    The trial is supported in part by a recently awarded Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) for the investigation of Galera's dismutase mimetics in combination with SBRT for the treatment of lung cancer. The grant was awarded by the NCI of the NIH under award number 4R44CA206795-02.

    "SBRT holds promise to deliver more efficient, targeted and potent radiotherapy to improve cancer outcomes. This trial builds on the pilot trial in combination with SBRT in patients with locally advanced pancreatic cancer and we are eager to embark on our exploration of the potential of Galera's GC4711 to enhance the anti-cancer efficacy of SBRT," said Mel Sorensen, M.D., President and CEO of Galera. "We're grateful for the support provided by the SBIR grant, which further recognizes the potential of this combination."

    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 the randomized, double-blind, placebo-controlled Phase 2 portion of the GRECO-1 trial. The goals of this trial are to assess the effects of GC4711 in combination with SBRT on tumor outcomes and lung injury.

    Additional information on the trial can be found on clinicaltrials.gov using the identifier NCT04476797.

    About GC4711

    Galera's product candidate, GC4711, is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic in development specifically for use in combination with stereotactic body radiation therapy (SBRT). GC4711 is designed to rapidly convert superoxide to hydrogen peroxide and is being developed to synergize with SBRT to exploit cancer cells' increased sensitivity to hydrogen peroxide to promote cancer cell death. In preclinical studies, GC4711, when added to an SBRT regimen, increased the anti-cancer efficacy of radiotherapy at current doses. GC4711 successfully completed Phase 1a clinical trials in healthy volunteers, and is currently being studied in a Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NSCLC).

    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. Enrollment has also been completed in a pilot Phase 1/2 trial of avasopasem 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'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 Phase 1/2 GRECO-1 clinical trial. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  20. MALVERN, Pa., Sept. 22, 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 it will host a virtual Key Opinion Leader (KOL) event on locally advanced pancreatic cancer on Friday, October 2, 2020, at 11 a.m. EDT.

    Sarah Hoffe, M.D., will provide a review of the management of patients with localized pancreatic cancer, including the current clinical treatment paradigm and the use of stereotactic body radiation therapy (SBRT). Dr. Hoffe is the Section Head of GI Radiation Oncology and Senior Member at Moffitt Cancer Center

    MALVERN, Pa., Sept. 22, 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 it will host a virtual Key Opinion Leader (KOL) event on locally advanced pancreatic cancer on Friday, October 2, 2020, at 11 a.m. EDT.

    Sarah Hoffe, M.D., will provide a review of the management of patients with localized pancreatic cancer, including the current clinical treatment paradigm and the use of stereotactic body radiation therapy (SBRT). Dr. Hoffe is the Section Head of GI Radiation Oncology and Senior Member at Moffitt Cancer Center.

    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 session by submitting pertinent 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 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 a Phase 2 trial in hospitalized patients who are critically ill with COVID-19; and avasopasem completed enrollment 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 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 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; 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.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

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  21. Trial to enroll up to 50 hospitalized adults critically ill with COVID-19

    Company continues to advance its three ongoing trials evaluating the potential of GC4419 to address radiation toxicities and improve the anti-cancer effect of radiation

    MALVERN, Pa., Sept. 16, 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 first patient has been dosed in a pilot Phase 2 clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to improve 28-day mortality in hospitalized patients who are…

    Trial to enroll up to 50 hospitalized adults critically ill with COVID-19

    Company continues to advance its three ongoing trials evaluating the potential of GC4419 to address radiation toxicities and improve the anti-cancer effect of radiation

    MALVERN, Pa., Sept. 16, 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 first patient has been dosed in a pilot Phase 2 clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to improve 28-day mortality in hospitalized patients who are critically ill with COVID-19. GC4419 is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen.

    "The unprecedented medical need of this pandemic has prompted many companies in our industry to test the potential utility of their technology to help fight this infection," said Mel Sorensen, M.D., President and CEO of Galera. "Our corporate mission continues to be that of transforming radiotherapy, and we remain focused on progressing our ongoing trials, most notably, our Phase 3 ROMAN trial for the reduction of radiation-induced severe oral mucositis in patients with head and neck cancer, as well as our Phase 2 anti-cancer trial in locally advanced pancreatic cancer in combination with stereotactic body radiation therapy. We look forward to exploring the potential of GC4419 in patients who are critically ill with COVID-19 while maintaining a disciplined approach to our resource allocation in support of this trial."

    The randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety and efficacy of GC4419 in improving 28-day mortality, compared to placebo. The trial will enroll up to 50 hospitalized adult patients critically ill with COVID-19 at several sites across the U.S. Patients in the trial will receive 90 mg of GC4419 or placebo by infusion twice daily for seven days. The trial will also collect additional data related to the requirement for intensive care, mechanical ventilation, and organ function.

    "Superoxide is reported in internal and published data to play a causative role in the progression of the hyperinflammatory phase of this infection, sometimes referred to as cytokine storm. Galera's dismutase mimetics have shown the ability in preclinical models to protect the lungs and other organs from damage caused by excessive and prolonged superoxide production," said Dennis Riley, Ph.D., Chief Scientific Officer of Galera. "Based upon the guidance of experts in pulmonary disease and viral infections, we have worked with the FDA to initiate this trial having recognized the importance of potentially contributing to the care of those affected by COVID-19."

    Multiple preclinical models suggest that by removing superoxide, GC4419 can potentially break the hyperinflammatory cycle, and reduce acute inflammatory lung injury and acute respiratory distress syndrome (ARDS). In preclinical models, GC4419 has shown it can prevent superoxide damage to the lungs by radiation therapy and other injuries. Other preclinical models also suggest that removing superoxide to inhibit the hyperinflammatory cycle might reduce COVID-19 damage to other organs and the related hypotension.

    For additional information about the trial, visit www.galeratx.com.

    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 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 in a Phase 2 trial in hospitalized patients who are critically ill with COVID-19; and avasopasem completed enrollment 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 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 (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 a Phase 2 trial in hospitalized patients who are critically ill with COVID-19; and avasopasem completed enrollment 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 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, including with respect to the Phase 2 clinical trial of avasopasem manganese (GC4419) for COVID-19. 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.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  22. MALVERN, Pa., Sept. 14, 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 virtually present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 22, 2020, at 1:40 p.m. EDT.

    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…

    MALVERN, Pa., Sept. 14, 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 virtually present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 22, 2020, at 1:40 p.m. EDT.

    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 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 completed enrollment 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 headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  23. MALVERN, Pa., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), 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. Today, Galera announced that data from its double-blind, placebo-controlled pilot Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) for locally advanced pancreatic cancer has been selected for presentation during the Late-breaking Special Session at the 2020 ASTRO Annual Meeting, which is taking place virtually October 25-28, 2020. GC4419 is an investigational, highly selective small molecule…

    MALVERN, Pa., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), 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. Today, Galera announced that data from its double-blind, placebo-controlled pilot Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) for locally advanced pancreatic cancer has been selected for presentation during the Late-breaking Special Session at the 2020 ASTRO Annual Meeting, which is taking place virtually October 25-28, 2020. GC4419 is an investigational, highly selective small molecule superoxide dismutase mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen.

    Details of the presentation are as follows:

    Abstract Title: "Randomized, Double-Blinded, Placebo-controlled Multicenter Adaptive Phase 1-2 Trial of GC4419, a Dismutase Mimetic, in Combination with High Dose Stereotactic Body Radiation Therapy (SBRT) in Locally Advanced Pancreatic Cancer (PC)"

    Session Title: SS 19 – Late-breaking Special Session

    Session Date: Tuesday, October 27, 2020

    Session Time: 3-4:15 p.m. EDT

    Presenter: Cullen Taniguchi, MD, MD Anderson Cancer Center

    For more information about the 2020 ASTRO Annual Meeting, please visit https://www.astro.org/Meetings-and-Education/Micro-Sites/2020/Annual-Meeting.

    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 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 completed enrollment 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 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 (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 completed enrollment 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 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 plans and timing for the release and presentation of data from clinical trials; and 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; 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.

    Investor Contacts:

    Christopher Degnan

    Galera Therapeutics, Inc.

    610-725-1500

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    gcestari@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  24. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    gcestari@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  25. 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

    cdegnan@galeratx.com 

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com 

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    gcestari@6degreespr.com 

    Primary Logo

    View Full Article Hide Full Article
  26. 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

    cdegnan@galeratx.com

    Jennifer Porcelli

    Solebury Trout

    646-378-2962

    jporcelli@soleburytrout.com

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    gcestari@6degreespr.com

     

    Primary Logo

    View Full Article Hide Full Article
  27. 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
    cdegnan@galeratx.com

    Jennifer Porcelli
    Solebury Trout
    646-378-2962
    jporcelli@soleburytrout.com 

    Media Contact:
    Gina Cestari
    6 Degrees
    917-797-7904
    gcestari@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  28. 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
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com 

    Primary Logo

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  29. MALVERN, Pa., May 13, 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 a retrospective analysis of Phase 2b trial data demonstrating the potential renal protective activity of lead candidate avasopasem manganese (GC4419), and two ongoing clinical trials evaluating avasopasem, will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. Abstracts are available now in the ASCO digital program, and presentations will be available for on-demand viewing…

    MALVERN, Pa., May 13, 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 a retrospective analysis of Phase 2b trial data demonstrating the potential renal protective activity of lead candidate avasopasem manganese (GC4419), and two ongoing clinical trials evaluating avasopasem, will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. Abstracts are available now in the ASCO digital program, and presentations will be available for on-demand viewing on May 29, 2020, at 8 a.m. EDT.

    "We look forward to sharing important clinical updates that underscore the potential of avasopasem to address radiation-induced toxicities and enhance the anti-cancer efficacy of chemoradiotherapy," said Mel Sorensen, M.D., President and CEO of Galera. "We're particularly excited to share, for the first time, new data supporting avasopasem's potential to improve chronic kidney disease markers in patients treated with cisplatin, a commonly used chemotherapy for cancer treatment. These data came from patients with head and neck cancer enrolled in our completed Phase 2b trial for the reduction of radiation-induced severe oral mucositis (SOM). In head and neck cancer treatment, where cisplatin is a mainstay, avasopasem may have the ability to prevent or mitigate two devastating toxicities of chemoradiotherapy – radiation-induced SOM and cisplatin-induced kidney damage."

    For the retrospective analysis (abstract 12071), pre- and post-treatment markers of kidney function were evaluated for a subset of patients from Galera's completed Phase 2b trial of avasopasem for the reduction of radiation-induced SOM in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of radiation therapy plus cisplatin, and were treated with either 30 mg or 90 mg of avasopasem or placebo. Kidney function markers indicate that treatment with the higher dose 90 mg avasopasem significantly reduced the incidence and severity of cisplatin-induced chronic kidney disease compared to placebo.

    "Chronic kidney disease is an underrecognized long-term complication of platinum-based chemotherapy occurring in up to 36 percent of patients with cancer receiving it and there is no medication to prevent or minimize it," said Diana Zepeda-Orozco, M.D., Nephrologist, Nationwide Children's Hospital. "These data indicate a promising dose-dependent protective effect of avasopasem that results in reduced incidence and severity of chronic kidney disease after chemotherapy, and further study is warranted."

    In addition to the chronic kidney disease data, two additional trial-in-progress (TIP) posters were selected for presentation during the virtual program. The abstracts describe the ongoing Phase 3 ROMAN clinical trial of avasopasem for the reduction of radiation-induced SOM in patients with locally advanced head and neck cancer receiving radiotherapy plus cisplatin (abstract TPS6596), and the ongoing pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (abstract TPS4670). Galera expects to present topline data from the pancreatic cancer trial in the second half of 2020, and from the ROMAN head and neck cancer trial in the second half of 2021.

    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, upcoming events and presentations, the potential, efficacy, and regulatory and clinical development of Galera's product candidates, and plans and timing for the commencement of and the release of data from Galera's clinical trials. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera's limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA's acceptance of data from clinical trials outside the United States; undesirable side effects from Galera's product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera's reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera's business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's 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
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

    Primary Logo

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  30. ROMAN Phase 3 Trial Topline Data Readout Guidance Updated to 2H21 Due to Impact of COVID-19

    Amendment to Royalty Agreement for Additional $37.5M Extends Cash Runway into 2H22

    Locally Advanced Pancreatic Cancer Phase 1b/2a Trial Topline Data Readout and Initiation of NSCLC Anti-cancer Phase 1b/2a Trial Both Remain On Track for 2H20

    MALVERN, Pa., May 12, 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 first quarter ended March 31, 2020, and provided business updates.

    "Despite these unprecedented…

    ROMAN Phase 3 Trial Topline Data Readout Guidance Updated to 2H21 Due to Impact of COVID-19

    Amendment to Royalty Agreement for Additional $37.5M Extends Cash Runway into 2H22

    Locally Advanced Pancreatic Cancer Phase 1b/2a Trial Topline Data Readout and Initiation of NSCLC Anti-cancer Phase 1b/2a Trial Both Remain On Track for 2H20

    MALVERN, Pa., May 12, 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 first quarter ended March 31, 2020, and provided business updates.

    "Despite these unprecedented times, we have continued to progress patient enrollment in our three ongoing clinical trials of lead candidate avasopasem manganese (GC4419)," said Mel Sorensen, M.D., President and CEO of Galera. "The COVID-19 pandemic has delayed the initiation of our Phase 2a trial in Europe in patients with head and neck cancer indefinitely, which we planned to start in the first half of this year. As a result, we are increasing the size of the Phase 3 ROMAN trial for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer to ensure we are positioned to achieve our targeted number of patients for the NDA safety database, and are updating our guidance for completing enrollment to the first half of 2021 and for reporting topline data to the second half of 2021. Investigator enthusiasm remains high and we are confident in our ability to complete our ongoing trials and maintain our supply chain. In addition, we're pleased to announce that we added $37.5 million in funding under our amended royalty agreement with Blackstone Life Sciences (formerly Clarus Ventures) which further strengthens our financial foundation and extends our cash runway into the second half of 2022."

    "In the near term, we are looking forward to avasopasem data being presented at ASCO, and are preparing to initiate an anti-cancer efficacy trial of our second product candidate, GC4711, in combination with stereotactic body radiation therapy (SBRT) in non-small cell lung cancer (NSCLC) in the second half of this year. We will continue to carefully monitor the COVID-19 situation and remain committed to thoughtfully executing our clinical programs to realize the potential of our pipeline in addressing radiation toxicities and improving the anti-cancer effect of radiation while prioritizing the health and safety of our partners and trial participants."

    Clinical Program Updates

    Galera will continue to assess the rapidly evolving impacts of COVID-19 on clinical programs and operations.

    Radiation-induced toxicity clinical trials:

    • Updated guidance for topline data from the Phase 3 ROMAN clinical trial of avasopasem for the treatment of SOM in patients with locally advanced head and neck cancer receiving radiotherapy to the second half of 2021. COVID-19 has delayed the initiation of the Phase 2a multi-center trial in Europe in patients with head and neck cancer indefinitely. This trial was expected to enroll up to 70 patients and contribute to the safety database for avasopasem for SOM in head and neck cancer. As a result, in order to ensure we are positioned to maintain the size of the safety database, the ROMAN trial target enrollment has been increased to 450 patients.
       
    • 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.

    Anti-cancer efficacy clinical trials:

    • Reaffirmed guidance for topline data from the pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem in combination with SBRT in patients with locally advanced pancreatic cancer in the second half of 2020.
       
    • Reaffirmed guidance for initiation of a Phase 1b/2a trial of GC4711 with SBRT in non-small cell lung cancer in the second half of 2020. GC4711 is Galera's second small molecule superoxide dismutase mimetic being developed to increase the anti-cancer efficacy of radiotherapy. This trial will evaluate GC4711 in combination with SBRT and with SBRT plus concurrent checkpoint inhibitor therapy in approximately 75 patients. A primary objective of the trial will be to assess the effects of GC4711 on measures of pneumonitis, or inflammation of the lungs. Other key objectives will include safety, local tumor control, distant metastasis rate, progression-free survival and overall survival.

    Corporate Updates

    • In May 2020, entered into an amendment to the 2018 royalty purchase agreement with Blackstone Life Sciences, which adds $37.5 million in additional funding to the existing $80 million royalty financing commitment that Blackstone Life Sciences (formerly Clarus Ventures) made in 2018. Under the updated agreement terms, we have agreed to pay Blackstone up to high single-digit percentage 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. Additional information regarding this amendment is included in a Form 8-K filed by the Company with the U.S. Securities and Exchange Commission on May 12, 2020.
       
    • In April 2020, announced three abstracts regarding avasopasem were accepted for presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. The titles of the abstracts are currently available in the ASCO digital program, with the full abstracts scheduled to be published on May 13, 2020. As previously announced, this includes the presentation titled "Effects of GC4419 (avasopasem manganese) on chronic kidney disease in head and neck cancer patients treated with radiation and cisplatin."
       
    • In April 2020, announced the appointment of Linda B. West to our board of directors. Ms. West brings nearly 40 years of business experience to Galera's board of directors, having served in multiple leadership roles of increasing responsibility for E. I. du Pont de Nemours and Company (DuPont) until her retirement in 2019.
       
    • In March 2020, implemented a work-from-home policy for office-based employees for the safety of employees and their families and to reduce the spread of COVID-19, while ensuring essential staffing levels in our operations remain in place, including maintaining key personnel in our laboratory.

    First Quarter 2020 Financial Highlights

    • Research and development expenses were $14.3 million in the first quarter of 2020, compared to $8.5 million for the same period in 2019. The increase was primarily attributable to avasopasem development costs due to greater patient enrollment and additional clinical site initiations in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a trial for the treatment of esophagitis in patients with lung cancer, initiation of additional toxicology studies 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 $3.6 million in the first quarter of 2020, compared to $1.9 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 $(18.4) million, or $(0.74) per share, for the first quarter of 2020, compared to a net loss of $(10.3) million, or $(41.12) per share, for the same period in 2019.
       
    • As of March 31, 2020, Galera had cash, cash equivalents and short-term investments of $120.5 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022.

    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 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, the anticipated direct and indirect impact of COVID-19 on Galera's business and operations, anticipated funding and payments under Galera's amended agreement with Blackstone, and the sufficiency of Galera's cash, cash equivalents and short-term investments, or cash runway. 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.

     
    Galera Therapeutics, Inc.
    Consolidated Statements of Operations
    (unaudited, in thousands except share and per share data)
           
      Three Months Ended March 31,
       2020    2019
    Operating expenses:      
    Research and development $ 14,252     $ 8,502  
    General and administrative   3,566       1,894  
    Loss from operations   (17,818 )     (10,396 )
    Other income (expense)   (599 )     47  
    Net loss   (18,417 )     (10,349 )
    Accretion of redeemable convertible preferred stock to redemption value   -       (2,011 )
    Net loss attributable to common stockholders $ (18,417 )   $ (12,360 )
           
    Net loss per share of common stock, basic and diluted $ (0.74 )   $ (41.12 )
    Weighed average common shares outstanding, basic and diluted   24,815,024       300,597  
           



    Galera Therapeutics, Inc.  
    Selected Consolidated Balance Sheet Data  
    (unaudited, in thousands)  
               
      March 31,
      December 31,
       2020    2019
               
    Cash, cash equivalents, and short-term investments $ 120,517     $ 112,290  
    Total assets   130,813       123,376  
    Total current liabilities   12,648       9,694  
    Total liabilities   77,755       53,768  
    Total stockholders' equity   53,058       69,608  
               

     

    Investor Contacts:
    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

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  31. MALVERN, Pa., May 05, 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 virtually present at the BofA Securities 2020 Health Care Conference on Tuesday, May 12, 2020, at 9:40 a.m. EDT.

    A live audio 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., May 05, 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 virtually present at the BofA Securities 2020 Health Care Conference on Tuesday, May 12, 2020, at 9:40 a.m. EDT.

    A live audio 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 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 a Phase 1 trial 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
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com 

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

    Primary Logo

    View Full Article Hide Full Article
  32. MALVERN, Penn., April 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 three abstracts regarding lead candidate avasopasem manganese (GC4419) were accepted for presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. The titles of the abstracts are currently available in the ASCO digital program, with the full abstracts scheduled to be published on May 13, 2020, at 5 p.m. EDT. Presentations will be available for on-demand viewing on May 29, 2020…

    MALVERN, Penn., April 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 three abstracts regarding lead candidate avasopasem manganese (GC4419) were accepted for presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, taking place May 29-31, 2020. The titles of the abstracts are currently available in the ASCO digital program, with the full abstracts scheduled to be published on May 13, 2020, at 5 p.m. EDT. Presentations will be available for on-demand viewing on May 29, 2020, at 8 a.m. EDT.

    Details of the presentations are as follows:

    Abstract Number: TPS4670

    Poster Number: 278

    Title: Adaptive dose optimization trial of stereotactic body radiation therapy (SBRT) with or without GC4419 (avasopasem manganese) in pancreatic cancer

    Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

    Presenter: Elizabeth C. Moser, M.D., Ph.D., VP of Clinical Development, Galera

    Abstract Number: 12071

    Poster Number: 359

    Title: Effects of GC4419 (avasopasem manganese) on chronic kidney disease in head and neck cancer patients treated with radiation and cisplatin

    Session: Symptoms and Survivorship

    Presenter: Emily J. Steinbach, Radiation Oncology, University of Iowa Hospitals and Clinics

    Abstract Number: TPS6596

    Poster Number: 257

    Title: ROMAN: Reduction in oral mucositis with avasopasem manganese (GC4419)–phase III trial in patients receiving chemoradiotherapy for locally advanced, nonmetastatic head and neck cancer

    Session: Head and Neck Cancer

    Presenter: Jon T. Holmlund, M.D., Chief Medical Officer, Galera

    About Avasopasem Manganese (GC4419)

    Galera's lead product candidate, avasopasem manganese (GC4419), is a 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 with approximately 365 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 is 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 ability 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 a Phase 1 trial 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

    cdegnan@galeratx.com

    Chiara Russo

    Solebury Trout

    617-221-9197

    crusso@soleburytrout.com

    Media Contact:

    Heather Anderson

    6 Degrees

    919-827-5539

    handerson@6degreespr.com

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  33. MALVERN, Pa., April 02, 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 appointment of Linda B. West to its board of directors. Additionally, as part of a planned transition, Jason Fuller, Ph.D., will not stand for re-election at Galera's annual meeting.

    "Linda is a proven and highly regarded business leader with extensive experience in transforming business operations, as well as spearheading governance, compliance and regulatory activities," said Mel Sorensen, M.D., President and CEO of Galera. "Her expertise will…

    MALVERN, Pa., April 02, 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 appointment of Linda B. West to its board of directors. Additionally, as part of a planned transition, Jason Fuller, Ph.D., will not stand for re-election at Galera's annual meeting.

    "Linda is a proven and highly regarded business leader with extensive experience in transforming business operations, as well as spearheading governance, compliance and regulatory activities," said Mel Sorensen, M.D., President and CEO of Galera. "Her expertise will be of tremendous value as we scale our organization and prepare to read out topline data from our Phase 3 ROMAN trial of lead candidate avasopasem manganese for the treatment of severe oral mucositis in people with head and neck cancer as well as the topline data from our pilot Phase 1/2a safety and anti-cancer trial in patients with locally advanced pancreatic cancer."

    Dr. Sorensen added, "I would also like to thank Jason for his many contributions to our board of directors, which were instrumental in helping Galera evolve from a small private company to a growing public company."

    Ms. West brings nearly 40 years of business experience to Galera's board of directors, having served in multiple leadership roles of increasing responsibility for E. I. du Pont de Nemours and Company (DuPont) until her retirement in 2019. She most recently served as Vice President for DuPont Corporate Planning & Analyses, where she led the execution of transformational transactions. Earlier in her tenure, Ms. West served in roles including Vice President & General Manager of DuPont Imaging Technologies, and Vice President & General Auditor and Chief Ethics & Compliance Officer. She holds a B.S. in accounting from the University of Delaware.

    "As Galera embarks on a period of growth, I look forward to bringing my experience in corporate planning and operations to bear to help chart a successful path forward for the company," said Ms. West. "I am enthusiastic about the potential of Galera's pipeline to make a difference in the lives of cancer patients receiving radiation treatment by reducing serious and debilitating radiation toxicities as well as increasing the anti-cancer effect of radiation."

    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 a Phase 1 trial 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
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com 

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

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  34. - Expanded Lead Product Candidate Avasopasem Manganese into Second Radiation Toxicity Indication -

    - Presented Data Demonstrating Avasopasem Manganese Maintained Anti-Cancer Benefit of Chemoradiotherapy for Head and Neck Cancer While Substantially Reducing Radiation-Induced Severe Oral Mucositis at 2020 Multidisciplinary Head and Neck Cancers Symposium -

    MALVERN, Pa., March 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 fourth quarter and year ended December 31, 2019, and highlighted recent…

    - Expanded Lead Product Candidate Avasopasem Manganese into Second Radiation Toxicity Indication -

    - Presented Data Demonstrating Avasopasem Manganese Maintained Anti-Cancer Benefit of Chemoradiotherapy for Head and Neck Cancer While Substantially Reducing Radiation-Induced Severe Oral Mucositis at 2020 Multidisciplinary Head and Neck Cancers Symposium -

    MALVERN, Pa., March 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 fourth quarter and year ended December 31, 2019, and highlighted recent corporate accomplishments.

    "Galera capped off a strong 2019 with the closing of an IPO for total gross proceeds of approximately $65 million, which positions us for growth and the continued advancement of our pipeline in 2020," said Mel Sorensen, M.D., President and CEO of Galera. "We kicked off 2020 by taking a critical step toward broadening our understanding of the breadth of our lead candidate avasopasem manganese's (GC4419) utility in addressing radiation toxicities with the initiation of a Phase 2a trial in a second radiation toxicity, esophagitis, in patients with lung cancer. We also presented data showing that avasopasem manganese maintained tumor outcomes, and remain on track to read out data from our ongoing pilot Phase 1b/2a safety and anti-cancer trial in patients with locally advanced pancreatic cancer in the second half of this year. The Phase 3 ROMAN trial continues to progress, and we look forward to reporting topline data in the first half of next year."

    Recent Corporate Highlights

    • In February 2020, presented full tumor outcomes results from the two-year follow-up of patients with head and neck cancer treated with avasopasem manganese (GC4419) for severe oral mucositis (SOM) in a Phase 2b clinical trial in a late-breaking oral presentation at the 2020 Multidisciplinary Head and Neck Cancers Symposium. At the final two-year mark, tumor outcomes were maintained in both avasopasem manganese dose groups (30 mg and 90 mg) compared to placebo. Specifically, outcomes for the 90 mg dose group, the dose currently being evaluated in the ongoing Phase 3 ROMAN trial, were comparable to placebo across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival.
       
    • In February 2020, received a $20.0 million payment from Clarus, investment funds managed by Blackstone Life Sciences, for achievement of the third specified clinical milestone in our Phase 3 ROMAN trial under our royalty purchase agreement with Clarus.
       
    • In January 2020, announced the first patient dosed in a Phase 2a clinical trial of avasopasem manganese to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer. Esophagitis, or mucositis of the esophagus, is a common and painful complication of radiation therapy for lung cancer. Symptoms can be life-threatening and include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss, and may require hospitalization.
       
    • In the fourth quarter of 2019, completed an initial public offering of common stock and raised net proceeds of $58.0 million.
       
    • Continued enrollment in two ongoing clinical trials evaluating avasopasem manganese. Enrollment in the Phase 3 ROMAN clinical trial of avasopasem manganese for the treatment of SOM in patients with locally advanced head and neck cancer receiving radiotherapy is on track to be completed in the second half of 2020, with topline data anticipated in the first half of 2021. Topline data from the pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem manganese in patients with locally advanced pancreatic cancer are expected in the second half of 2020.

    Fourth Quarter 2019 Financial Highlights

    • Research and development expenses were $13.3 million in the fourth quarter of 2019, compared to $7.1 million for the same period in 2018. The increase was primarily attributable to avasopasem manganese and GC4711 development costs. Galera initiated the Phase 3 ROMAN clinical trial in October 2018, progressed chronic toxicology studies of avasopasem manganese to support registration, and progressed a Phase 1 clinical trial and additional toxicology studies of GC4711.
       
    • General and administrative expenses were $2.9 million in the fourth quarter of 2019, compared to $1.7 million for the same period in 2018. The increase was primarily the result of employee-related costs from increased headcount and increased insurance, professional fees and other operating costs as a result of becoming a public company.
       
    • Galera reported a net loss of $(16.7) million, or $(1.31) per share, for the fourth quarter of 2019, compared to a net loss of $(8.6) million, or $(35.24) per share, for the same period in 2018.
       
    • As of December 31, 2019, Galera had cash, cash equivalents and short-term investments of $112.3 million. Galera expects that its existing cash, cash equivalents and short-term investments, including the $20.0 million payment received from Clarus in February 2020 for the achievement of the third clinical milestone in the Phase 3 ROMAN clinical trial, together with the $20.0 million payment from Clarus expected to be received upon the achievement of the remaining specified clinical milestone in the ROMAN trial, will enable Galera to fund its operating expenses and capital expenditure requirements into 2022.

    Full Year 2019 Financial Highlights

    • Research and development expenses were $42.3 million for the year ended December 31, 2019, compared to $18.7 million for the year ended December 31, 2018. The increase was primarily attributable to avasopasem manganese and GC4711 development costs. Galera initiated the Phase 3 ROMAN clinical trial in October 2018, began chronic toxicology studies of avasopasem manganese to support registration, and initiated a Phase 1 clinical trial and additional toxicology studies of GC4711.
       
    • General and administrative expenses were $8.4 million for the year ended December 31, 2019, compared to $5.6 million for the year ended December 31, 2018. The increase was primarily the result of employee-related costs from increased headcount and increased insurance, professional fees and other operating costs as a result of becoming a public company.
       
    • Galera reported a net loss of $(51.9) million, or $(16.31) per share, for the year ended December 31, 2019, compared to a net loss of $(23.7) million, or $(98.42) per share, for the year ended December 31, 2018.

    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 a Phase 1 trial 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 release of data from Galera's clinical trials, 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; risks related to ownership of Galera's common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in Galera's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

                   
    Galera Therapeutics, Inc.
    Consolidated Statements of Operations
    (in thousands, except share and per share data)
                   
      Three Months Ended December 31,   Year Ended December 31,
      2019   2018   2019   2018
    Operating expenses:              
    Research and development $ 13,276     $ 7,112     $ 42,333     $ 18,663  
    General and administrative   2,892       1,746       8,358       5,592  
    Loss from operations   (16,168 )     (8,858 )     (50,691 )     (24,255 )
    Other income (expense)   (513 )     213       (1,248 )     356  
    Loss before income tax benefit   (16,681 )     (8,645 )     (51,939 )     (23,899 )
    Income tax benefit   9       82       9       223  
    Net loss   (16,672 )     (8,563 )     (51,930 )     (23,676 )
    Accretion of redeemable convertible preferred stock to redemption value   (998 )     (2,031 )     (7,176 )     (5,910 )
    Net loss attributable to common stockholders $ (17,670 )   $ (10,594 )   $ (59,106 )   $ (29,586 )
                   
    Net loss per share of common stock, basic and diluted $ (1.31 )   $ (35.24 )   $ (16.31 )   $ (98.42 )
    Weighed average common shares outstanding, basis and diluted   13,489,826       300,597       3,625,005       300,597  
                   


           
    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (in thousands)
           
      December 31,
      2019
      2018
           
    Cash, cash equivalents, and short-term investments $ 112,290     $ 81,517  
    Total assets   123,376       88,056  
    Total current liabilities   9,694       6,444  
    Total liabilities   53,768       26,974  
    Redeemable convertible preferred stock   -       165,902  
    Total stockholders' equity (deficit)   69,608       (104,820 )
           

    Investor Contacts:
    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com 

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

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  35. MALVERN, Pa., Feb. 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 full tumor outcomes results from the two-year follow-up of patients with head and neck cancer treated with avasopasem manganese (GC4419), Galera's lead product candidate for severe oral mucositis (SOM), in a Phase 2b clinical trial. The results will be presented February 28, 2020, during a late-breaking oral presentation at the 2020 Multidisciplinary Head and Neck Cancers Symposium in Scottsdale, Ariz.

    "There is currently no drug to prevent or treat…

    MALVERN, Pa., Feb. 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 full tumor outcomes results from the two-year follow-up of patients with head and neck cancer treated with avasopasem manganese (GC4419), Galera's lead product candidate for severe oral mucositis (SOM), in a Phase 2b clinical trial. The results will be presented February 28, 2020, during a late-breaking oral presentation at the 2020 Multidisciplinary Head and Neck Cancers Symposium in Scottsdale, Ariz.

    "There is currently no drug to prevent or treat SOM, one of the most common and disruptive side effects of radiation therapy that severely impacts both a patient's quality of life and treatment experience," said Mel Sorensen, M.D., President and CEO of Galera Therapeutics. "Avasopasem manganese's efficacy and tumor outcomes in SOM underscore its potential to complement a standard radiation therapy regimen and change the standard of care for the reduction of SOM in patients with head and neck cancer receiving radiotherapy. We look forward to the continued evaluation of avasopasem manganese for the treatment of SOM in our ongoing Phase 3 ROMAN trial, as well as for other radiation-induced toxicities, such as esophagitis in lung cancer in our ongoing Phase 2a trial."

    Avasopasem manganese is a highly selective small molecule superoxide dismutase (SOD) mimetic initially being developed for the reduction of radiation-induced SOM defined by the World Health Organization as Grade 3 or 4, a common side effect characterized by significant pain and the inability to eat solid food or drink liquids. Galera's completed Phase 2b clinical trial evaluated avasopasem manganese in patients with locally advanced head and neck cancer. Patients in the trial received seven weeks of radiation therapy plus cisplatin, and were treated with either 30 mg or 90 mg of avasopasem manganese or placebo by infusion on the days they received their radiation treatment.

    As part of the trial, Galera assessed tumor outcomes of the patients over a two-year period following radiation therapy. At both the one-year interim assessment and final two-year mark, tumor outcomes were maintained in both avasopasem manganese dose groups compared to placebo. Specifically, outcomes for the 90 mg dose group, the dose currently being evaluated in the ongoing Phase 3 ROMAN trial, were comparable to placebo across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival.

    "Radiation-induced toxicities like SOM are prevalent and debilitating complications of cancer treatment," said Carryn Anderson, M.D., Radiation Oncologist, University of Iowa Hospitals and Clinics, and lead investigator. "SOM in head and neck cancer patients, in particular, may be associated with dose reductions and / or radiation treatment breaks which can limit the antitumor efficacy of radiation therapy and impede successful tumor management. The tumor outcomes resulting from treatment with avasopasem manganese were consistent with expectations for concurrent intensity-modulated radiation therapy (IMRT)/cisplatin in patients with head and neck cancer and demonstrate avasopasem manganese's potential to mitigate this devastating side effect while maintaining radiation efficacy."

    Trial results previously disclosed also demonstrated that adding a 90 mg dose of avasopasem manganese to a standard radiotherapy regimen produced a statistically significant reduction in duration of SOM from 19 days to 1.5 days (92 percent), and clinically meaningful reductions in SOM incidence through completion of radiation by 34 percent and in the severity of oral mucositis (OM) (incidence of Grade 4 OM) by 47 percent.

    About Avasopasem Manganese (GC4419)

    Galera's lead product candidate, avasopasem manganese (GC4419), is a 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 with approximately 365 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 is 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 ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer, 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 a Phase 1 trial 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 the potential, efficacy, and regulatory and clinical development of Galera's product candidates, including the Phase 3 ROMAN trial and the Phase 2a clinical trial of avasopasem manganese to reduce the incidence of radiation-induced esophagitis in patients with lung cancer. 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; 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; 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 quarter ended September 30, 2019 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contacts:
    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

     

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  36. MALVERN, Pa., Feb. 24, 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 a late-breaker presentation at the 2020 Multidisciplinary Head and Neck Cancers Symposium, which is taking place February 27-29, 2020, in Scottsdale, Ariz. The presentation includes final data from the two-year tumor outcomes follow up of patients with head and neck cancer treated with Galera's lead product candidate, avasopasem manganese (GC4419), for severe oral mucositis (SOM) in a Phase 2b clinical trial.

    Details of the presentation are as follows…

    MALVERN, Pa., Feb. 24, 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 a late-breaker presentation at the 2020 Multidisciplinary Head and Neck Cancers Symposium, which is taking place February 27-29, 2020, in Scottsdale, Ariz. The presentation includes final data from the two-year tumor outcomes follow up of patients with head and neck cancer treated with Galera's lead product candidate, avasopasem manganese (GC4419), for severe oral mucositis (SOM) in a Phase 2b clinical trial.

    Details of the presentation are as follows:

    Presentation Number: LBA 2
    Title: Tumor Outcomes of Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer 
    Session: Oral Abstract Session
    Date/Time: Friday, February 28, 2020, 10:45 a.m. – 12:15 p.m. MST
    Presenter: Carryn Anderson, M.D., Radiation Oncologist, University of Iowa Hospitals and Clinics

    The 2020 Multidisciplinary Head and Neck Cancers Symposium brings the head and neck cancer community together to provide the most up-to-date information on multidisciplinary therapies, clinical research, treatment strategies, supportive care, scientific breakthroughs and toxicity mitigation. The meeting is cosponsored by the American Society for Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO), the American Head and Neck Society (AHNS) and the Society for Immunotherapy of Cancer (SITC). For more information, visit https://www.headandnecksymposium.org/.

    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, severity and duration of radiation-induced SOM in patients with locally advanced head and neck cancer being treated with radiotherapy, its lead indication, and in the Phase 2a trial for its ability to reduce the incidence of radiation-induced esophagitis 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 a Phase 1 trial 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
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

     

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  37. MALVERN, Pa., Feb. 19, 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 Cowen and Company 40th Annual Health Care Conference in Boston on Wednesday, March 4, 2020, at 9:20 a.m. EST.

    A live audio 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…

    MALVERN, Pa., Feb. 19, 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 Cowen and Company 40th Annual Health Care Conference in Boston on Wednesday, March 4, 2020, at 9:20 a.m. EST.

    A live audio 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 manganese is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence, severity and duration of radiation-induced SOM in patients with locally advanced head and neck cancer being treated with radiotherapy, its lead indication, and in the Phase 2a trial for its ability to reduce the incidence of radiation-induced esophagitis 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 a Phase 1 trial 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
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com

    Media Contact:
    Heather Anderson
    6 Degrees
    919-827-5539
    handerson@6degreespr.com

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  38. -- Evaluates avasopasem manganese's ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer --

    -- Marks expansion of lead product candidate avasopasem manganese into second radiation toxicity indication --

    MALVERN, Pa., Jan. 07, 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 first patient has been dosed in a Phase 2a clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients…

    -- Evaluates avasopasem manganese's ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer --

    -- Marks expansion of lead product candidate avasopasem manganese into second radiation toxicity indication --

    MALVERN, Pa., Jan. 07, 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 first patient has been dosed in a Phase 2a clinical trial of lead product candidate avasopasem manganese (GC4419) to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer.

    The open-label, multi-center trial will evaluate the efficacy of avasopasem manganese, a highly selective small molecule superoxide dismutase (SOD) mimetic, in reducing the incidence of severe (Grade 2 or worse on the NCI Common Terminology Criteria for Adverse Events scale) acute radiation-induced esophagitis in patients with lung cancer receiving chemoradiotherapy. Approximately 60 adult patients with pathologically confirmed unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers will be enrolled at approximately 10 sites. Patients in the trial will receive 90 mg of avasopasem manganese by infusion on the days they receive their radiation therapy.

    "Radiation-induced esophagitis is a common, debilitating side effect that can delay or prevent curative cancer treatment, and no FDA-approved therapies to treat it currently exist," said Lawrence Berk, M.D., Ph.D., Professor of Radiation Oncology at the University of South Florida and lead investigator of the Phase 2a trial. "The initiation of this trial is a critical step toward addressing this urgent unmet need for a treatment option. The results of the Phase 2b trial of avasopasem manganese which demonstrated its ability to reduce the incidence of radiation-induced severe oral mucositis – another debilitating radiotherapy side effect – in patients with head and neck cancer support the further evaluation of avasopasem manganese for the treatment of other related radiation toxicities like esophagitis."

    There are approximately 230,000 new lung cancer patients diagnosed annually in the United States, and approximately 50,000 of those are treated with radiation therapy. Esophagitis, or mucositis of the esophagus, is a common and painful complication of radiation therapy for lung cancer. Symptoms can be life-threatening and include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss, and may require hospitalization.

    "We're pleased to expand the evaluation of avasopasem manganese into a second radiation toxicity, esophagitis, in patients with lung cancer," said Mel Sorensen, M.D., President and CEO of Galera. "Galera is committed to improving the quality of life for patients suffering from cancer. This trial will broaden our understanding of the utility of avasopasem manganese in the treatment of radiotherapy toxicities beyond our first indication, radiation-induced severe oral mucositis in patients with head and neck cancer."

    About Avasopasem Manganese (GC4419)

    Galera's lead product candidate, avasopasem manganese (GC4419), is a 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.

    GC4419 is currently being studied in the ROMAN trial, a randomized, double blind, placebo-controlled Phase 3 trial with 365 patients (NCT03689712 available at clinicaltrials.gov) to determine the efficacy and safety of avasopasem manganese in patients with locally advanced head and neck cancer and radiation-induced OM. In Galera's 223-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial in patients with locally advanced head and neck cancer receiving concurrent radiation therapy, avasopasem manganese significantly reduced the duration of SOM by 92 percent (from 19 days to 1.5 days in the 90 mg treatment arm). The incidence of SOM and the incidence of Grade 4 OM were also significantly reduced (by 34 percent and 47 percent, respectively, in the 90 mg treatment arm) in patients treated with avasopasem manganese. No significant safety signals were observed demonstrating avasopasem manganese is 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 ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer, 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 the duration, incidence and severity 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, severity and duration of radiation-induced SOM in patients with locally advanced head and neck cancer being treated with radiotherapy, its lead indication. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem manganese for the reduction of the duration, incidence and severity of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, which successfully completed a Phase 1 trial 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 the potential, efficacy, and regulatory and clinical development of Galera's product candidates, including the Phase 2a clinical trial of avasopasem manganese to reduce the incidence of radiation-induced esophagitis in patients with lung cancer. 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; 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; 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 quarter ended September 30, 2019 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contacts:
    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500
    cdegnan@galeratx.com

    Chiara Russo
    Solebury Trout
    617-221-9197
    crusso@soleburytrout.com 

    Media Contact:
    Heather Anderson
    6 Degrees
    980-938-0260
    handerson@6degreespr.com

     

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  39. - Completed Initial Public Offering of Common Stock That Raised Approximately $58 Million in Net Proceeds -

    - Progressed Pivotal Clinical Trial of GC4419 in Head & Neck Cancer with Topline Data Expected in 1H 2021 - 

    MALVERN, Pa., Dec. 10, 2019 (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, 2019, and highlighted recent corporate accomplishments.

    "2019 has been a momentous year for Galera, culminating in the closing of our IPO last month," said Mel Sorensen, M.D…

    - Completed Initial Public Offering of Common Stock That Raised Approximately $58 Million in Net Proceeds -

    - Progressed Pivotal Clinical Trial of GC4419 in Head & Neck Cancer with Topline Data Expected in 1H 2021 - 

    MALVERN, Pa., Dec. 10, 2019 (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, 2019, and highlighted recent corporate accomplishments.

    "2019 has been a momentous year for Galera, culminating in the closing of our IPO last month," said Mel Sorensen, M.D., President and CEO of Galera. "We look forward to continuing to advance our clinical development of GC4419 and GC4711, which we believe could change the management of radiation therapy by both protecting normal tissue and improving the effectiveness of radiation."

    Third Quarter 2019 and Recent Corporate Highlights

    • In November 2019, completed an initial public offering of common stock and raised net proceeds of approximately $58.1 million, after deducting the underwriting discounts and other offering expenses, through the sale of 5,445,690 common shares, including shares sold pursuant to the partial exercise of the underwriters' option to purchase additional shares in December 2019, at a public offering price of $12.00 per share.
       
    • Continued enrollment in the Phase 3 ROMAN clinical trial of GC4419 for the treatment of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer receiving radiotherapy with enrollment expected to be completed by the second half of 2020. Galera anticipates reporting topline data in the first half of 2021.
       
    • Continued enrollment in the pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of GC4419 in patients with locally advanced pancreatic cancer with topline data expected in the second half of 2020.
       
    • In December 2019, full results from the 223-patient, randomized, double-blind Phase 2b clinical trial of GC4419 for the treatment of SOM in patients with locally advanced head and neck cancer receiving radiotherapy were published in the Journal of Clinical Oncology, a journal of the American Society of Clinical Oncology (ASCO). The paper, titled, "Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer," reinforces the potential of GC4419 to address a serious unmet need for a therapy to reduce the incidence and severity of radiation-induced SOM, for which there is currently no FDA-approved drug.
       
    • In October 2019, announced final data from the two-year tumor outcomes follow up of patients enrolled in the Phase 2b clinical trial of GC4419 for the treatment of SOM in patients with locally advanced head and neck cancer receiving radiotherapy. At both the one-year interim assessment and final two-year mark, tumor outcomes were maintained across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival – in both GC4419 dose groups (30 mg and 90 mg) compared to placebo.
       
    • In October 2019, strengthened Galera's leadership team with the appointment of Christopher Degnan as Chief Financial Officer.

    Third Quarter Financial Highlights

    • Research and development expenses were $11.0 million in the third quarter of 2019, compared to $4.2 million for the same period in 2018. The increase was primarily attributable to GC4419 and GC4711 development costs. Galera initiated the Phase 3 ROMAN trial in October 2018, began chronic toxicology studies of GC4419 to support registration, and initiated a Phase 1 clinical trial and additional toxicology studies of GC4711.
       
    • General and administrative expenses were $1.8 million in the third quarter of 2019, compared to $1.2 million for the same period in 2018. The increase was primarily the result of employee-related costs from increased headcount.
       
    • Galera reported a net loss of $(13.4) million, or $(51.43) per share, for the third quarter of 2019, compared to a net loss of $(5.2) million, or $(22.35) per share, for the same period in 2018.
       
    • As of September 30, 2019, Galera had cash, cash equivalents, and short-term investments of $67.9 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the net proceeds from the IPO and assumed payments from Clarus in the amount of $40 million upon the achievement of the two remaining specified clinical milestones in the ROMAN trial, will enable Galera to fund its operating expenses and capital expenditure requirements into 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 GC4419 (avasopasem manganese), a potent and highly selective small molecule dismutase mimetic being developed for the reduction of severe oral mucositis (SOM). GC4419 is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence, severity and duration of SOM in patients with locally advanced head and neck cancer, its lead indication. The FDA granted Fast Track and Breakthrough Therapy designations to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiotherapy. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations surrounding the potential, efficacy, and regulatory and clinical development of Galera's product candidates, plans and timing for the release of data from Galera's clinical trials, 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 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; 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 quarter ended September 30, 2019 filed with the U.S. Securities and Exchange Commission (SEC) and Galera's other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


    Galera Therapeutics, Inc.
    Consolidated Statements of Operations
    (unaudited, in thousands except share and per share data)
                   
      Three Months Ended
    September 30,
      Nine Months Ended
    September 30,
        2019       2018       2019       2018  
    Operating expenses:              
    Research and development $ 11,040     $ 4,162     $ 29,057     $ 11,551  
    General and administrative   1,816       1,245       5,466       3,846  
    Loss from operations   (12,856 )     (5,407 )     (34,523 )     (15,397 )
    Other income (expense)   (495 )     106       (735 )     143  
    Loss before income tax benefit   (13,351 )     (5,301 )     (35,258 )     (15,254 )
    Income tax benefit   -       52       -       141  
    Net loss   (13,351 )     (5,249 )     (35,258 )     (15,113 )
    Accretion of redeemable convertible preferred stock to redemption value   (2,108 )     (1,468 )     (6,178 )     (3,879 )
    Net loss attributable to common stockholders $ (15,459 )   $ (6,717 )   $ (41,436 )   $ (18,992 )
                   
    Net loss per share of common stock, basic and diluted $ (51.43 )   $ (22.35 )   $ (137.85 )   $ (63.18 )
    Weighed average common shares outstanding, basis and diluted   300,597       300,597       300,597       300,597  


    Galera Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)
           
      September 30, 2019   December 31, 2018
           
    Cash, cash equivalents, and short-term investments $ 67,945     $ 81,517  
    Total assets   79,758       88,056  
    Total current liabilities   9,083       6,444  
    Total liabilities   52,298       26,974  
    Redeemable convertible preferred stock   172,080       165,902  
    Total stockholders' deficit   (144,620 )     (104,820 )


    Investor Contact:

    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500
    cdegnan@galeratx.com

    Media Contact:
    Heather Anderson
    6 Degrees
    980-938-0260
    handerson@6degreespr.com

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  40. MALVERN, Pa., Dec. 05, 2019 (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 full results from the 223-patient, randomized, double-blind Phase 2b clinical trial of lead candidate GC4419 (avasopasem manganese) in patients with locally advanced head and neck cancer have been published in the Journal of Clinical Oncology, a journal of the American Society of Clinical Oncology (ASCO).

    Data in the paper, titled, "Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent…

    MALVERN, Pa., Dec. 05, 2019 (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 full results from the 223-patient, randomized, double-blind Phase 2b clinical trial of lead candidate GC4419 (avasopasem manganese) in patients with locally advanced head and neck cancer have been published in the Journal of Clinical Oncology, a journal of the American Society of Clinical Oncology (ASCO).

    Data in the paper, titled, "Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer," demonstrated that adding a 90 mg dose of GC4419 to a standard radiotherapy regimen produced a significant reduction of severe oral mucositis (SOM) duration from 19 days to 1.5 days (92 percent), and improvement in SOM incidence through completion of radiation by 34 percent and improvement in oral mucositis (OM) severity (Grade 4 OM incidence) by 47 percent.

    Carryn Anderson, M.D., Radiation Oncologist, University of Iowa Hospitals and Clinics, and lead investigator, said, "The clinically meaningful Phase 2b data highlight the potential of GC4419 to address a serious unmet need for a therapy to reduce the incidence and severity of radiation-induced severe oral mucositis, for which there is currently no FDA-approved drug. I look forward to the results of the pivotal ongoing ROMAN clinical trial which will potentially reinforce these promising findings."

    "We are pleased that our GC4419 Phase 2b data have been published in the preeminent peer-reviewed oncology journal. These data, like the data previously presented at ASCO, ASTRO and MASCC, reinforce GC4419's potential to make a meaningful difference for head and neck cancer patients suffering from severe oral mucositis, a debilitating toxicity," said Mel Sorensen, M.D., President and CEO of Galera. "Enrollment in our Phase 3 ROMAN clinical trial of GC4419 in patients with locally advanced head and neck cancer continues, and we anticipate reporting topline data in the first half of 2021."

    About GC4419 (Avasopasem Manganese)
    Galera's lead product candidate, GC4419 (avasopasem manganese), is a potent and highly selective small molecule dismutase mimetic that is being developed for the reduction of SOM. GC4419 is designed to rapidly convert superoxide to hydrogen peroxide, reducing mucosal damage and thereby the incidence and severity of mucositis. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis, which can limit the anti-tumor efficacy of radiation therapy.

    GC4419 is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence, severity and duration of SOM in patients with locally advanced head and neck cancer, its lead indication. In Galera's 223-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial, GC4419 demonstrated the ability to reduce the duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients' OM by 47 percent, and GC4419 was well tolerated in the trial when added to a standard radiotherapy regimen. The two-year tumor outcomes follow up of patients enrolled in the trial also demonstrated that GC4419, when added to a standard radiotherapy regimen, maintained the efficacy of treatment, with tumor outcomes maintained across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival – in both GC4419 dose groups (30 mg and 90 mg) compared to placebo. GC4419 is also currently being studied in combination with SBRT for its anti-tumor effect in a pilot Phase 1b/2a trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

    The U.S. Food and Drug Administration granted Fast Track and Breakthrough Therapy designations to GC4419 for the reduction of the duration, incidence and severity 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 GC4419 (avasopasem manganese), a potent and highly selective small molecule dismutase mimetic being developed for the reduction of severe oral mucositis (SOM). GC4419 is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence, severity and duration of SOM in patients with locally advanced head and neck cancer, its lead indication. The FDA granted Fast Track and Breakthrough Therapy designations to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiotherapy. Galera is headquartered in Malvern, PA.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations surrounding the potential, efficacy, and regulatory and clinical development of Galera's product candidates, and plans and timing for the release of data from Galera's clinical trials. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following:  Galera's limited operating history;  anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera's dependence on 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; 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 prospectus filed with the U.S. Securities and Exchange Commission (SEC) pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, on November 8, 2019, 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.                 

    Media Contact:
    Heather Anderson
    6 Degrees
    980-938-0260
    handerson@6degreespr.com

    Investor Contact:
    Christopher Degnan
    Galera Therapeutics, Inc.
    610-725-1500
    cdegnan@galeratx.com

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