U.S. markets closed

Galera Therapeutics, Inc. (GRTX)

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
Add to watchlist
6.97+0.50 (+7.73%)
At close: 4:00PM EDT

7.05 +0.08 (1.15%)
After hours: 5:21PM EDT

Full screen
Trade prices are not sourced from all markets
Gain actionable insight from technical analysis on financial instruments, to help optimize your trading strategies
Chart Events
Bullishpattern detected
Outside Bar (Bullish)

Outside Bar (Bullish)

Previous Close6.47
Open6.06
Bid6.93 x 800
Ask7.15 x 1400
Day's Range6.01 - 7.19
52 Week Range5.87 - 15.00
Volume349,646
Avg. Volume579,138
Market Cap176.021M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
Fair Value is the appropriate price for the shares of a company, based on its earnings and growth rate also interpreted as when P/E Ratio = Growth Rate. Estimated return represents the projected annual return you might expect after purchasing shares in the company and holding them over the default time horizon of 5 years, based on the EPS growth rate that we have projected.
Fair Value
XX.XX
Overvalued
Research that delivers an independent perspective, consistent methodology and actionable insight
Related Research
View more
  • Galera Reports First Quarter 2021 Financial Results and Recent Accomplishments
    GlobeNewswire

    Galera Reports First Quarter 2021 Financial Results and Recent Accomplishments

    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 $72,776Total assets 70,486 84,098Total current liabilities 15,855 13,968Total liabilities 81,059 77,980Total stockholders' equity (deficit) (10,573) 6,118 Investor Contacts:Christopher DegnanGalera Therapeutics, Inc.610-725-1500cdegnan@galeratx.com William WindhamSolebury Trout646-378-2946wwindham@soleburytrout.com Media Contact:Zara LockshinSolebury Trout646-378-2960zlockshin@soleburytrout.com

  • Galera to Participate in the BofA Securities 2021 Virtual Healthcare Conference
    GlobeNewswire

    Galera to Participate in the BofA Securities 2021 Virtual Healthcare Conference

    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 DegnanGalera Therapeutics, Inc.610-725-1500cdegnan@galeratx.com William WindhamSolebury Trout646-378-2946wwindham@soleburytrout.com Media Contact:Zara LockshinSolebury Trout646-378-2960zlockshin@soleburytrout.com

  • Galera Announces Updated Data from its Randomized, Multicenter, Placebo-Controlled Trial in Patients with Pancreatic Cancer
    GlobeNewswire

    Galera Announces Updated Data from its Randomized, Multicenter, Placebo-Controlled Trial in Patients with Pancreatic Cancer

    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 DegnanGalera Therapeutics, Inc.610-725-1500cdegnan@galeratx.com Jennifer PorcelliSolebury Trout646-378-2962jporcelli@soleburytrout.com Media Contact:Zara LockshinSolebury Trout646-378-2960zlockshin@soleburytrout.com