A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)

A Trial of GC4419 in Patients with Critical Illness due to COVID-19

Start Date09 Sep 2020

Sponsor / Collaborator

Galera Therapeutics, Inc.

NCT05412472 / CompletedPhase 1

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419

The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.

Start Date04 Apr 2019

Sponsor / Collaborator

Galera Therapeutics, Inc.

NCT03792971 / CompletedPhase 1

Phase 1, Open-label, One-arm, Fixed-sequence Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects

This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.

Start Date10 Feb 2019

Sponsor / Collaborator

Galera Therapeutics, Inc.

100 Clinical Results associated with Avasopasem manganese

100 Translational Medicine associated with Avasopasem manganese

100 Patents (Medical) associated with Avasopasem manganese

Literatures (Medical) associated with Avasopasem manganese

01 Apr 2024·Redox biology

The antioxidant and anti-inflammatory activities of avasopasem manganese in age-associated, cisplatin-induced renal injury

Article

Author: Wen, Hsiang ; Zepeda-Orozco, Diana ; Spitz, Douglas R ; Beardsley, Robert ; Dayal, Sanjana ; Griffin, Benjamin R ; Mapuskar, Kranti A ; Pulliam, Casey F ; Allen, Bryan G ; Kennedy, Eugene P ; Rastogi, Prerna ; Anderson, Carryn M ; Sindler, Amy L ; Tomanek-Chalkley, Ann

PURPOSE:

Cisplatin contributes to acute kidney injury (AKI) and chronic kidney disease (CKD) that occurs with greater frequency and severity in older patients. Age-associated cisplatin sensitivity in human fibroblasts involves increased mitochondrial superoxide produced by older donor cells.

EXPERIMENTAL DESIGN:

Young and old C57BL/6 J murine models of cisplatin-induced AKI and CKD were treated with the SOD mimetic avasopasem manganese to investigate the potential antioxidant and anti-inflammatory effects. Adverse event reporting from a phase 2 and a phase 3 randomized clinical trial (NCT02508389 and NCT03689712) conducted in patients treated with cisplatin and AVA was determined to have established the incidence and severity of AKI.

RESULTS:

Cisplatin-induced AKI and CKD occurred in all mice, however, was more pronounced in older mice. AVA reduced cisplatin-induced mortality, AKI, and CKD, in older animals. AVA also alleviated cisplatin-induced alterations in mitochondrial electron transport chain (ETC) complex activities and NADPH Oxidase 4 (NOX4) and inhibited the increased levels of the inflammation markers, TNFα, IL1, ICAM-1, and VCAM-1. Analysis of age-stratified subjects treated with cisplatin from clinical trials (NCT02508389, NCT03689712) also supported that the incidence of AKI increased with age and AVA reduced age-associated therapy-induced adverse events (AE), including hypomagnesemia, increased creatinine, and AKI.

CONCLUSIONS:

Older mice and humans are more susceptible to cisplatin-induced kidney injury, and treatment with AVA mitigates age-associated damage. Mitochondrial ETC and NOX4 activities represent sources of superoxide production contributing to cisplatin-induced kidney injury, and pro-inflammatory cytokine production and endothelial dysfunction may also be increased by superoxide formation.

28 Dec 2023·Brain communications

Role of oxidative stress in neurodegenerative disorders: a review of reactive oxygen species and prevention by antioxidants

Review

Author: Houldsworth, Annwyne

Abstract:

Neurological disorders include a variety of conditions, including Alzheimer’s disease, motor neuron disease and Parkinson’s disease, affecting longevity and quality of life, and their pathogenesis is associated with oxidative stress. Several of the chronic neurodegenerative pathologies of the CNS share some common features, such as oxidative stress, inflammation, synapse dysfunctions, protein misfolding and defective autophagia. Neuroinflammation can involve the activation of mast cells, contributing to oxidative stress, in addition to other sources of reactive oxygen species. Antioxidants can powerfully neutralize reactive oxygen species and free radicals, decreasing oxidative damage. Antioxidant genes, like the manganese superoxide dismutase enzyme, can undergo epigenetic changes that reduce their expression, thus increasing oxidative stress in tissue. Alternatively, DNA can be altered by free radical damage. The epigenetic landscape of these genes can change antioxidant function and may result in neurodegenerative disease. This imbalance of free radical production and antioxidant function increases the reactive oxygen species that cause cell damage in neurons and is often observed as an age-related event. Increased antioxidant expression in mice is protective against reactive oxygen species in neurons as is the exogenous supplementation of antioxidants. Manganese superoxide dismutase requires manganese for its enzymic function. Antioxidant therapy is considered for age-related neurodegenerative diseases, and a new mimetic of a manganese superoxide dismutase, avasopasem manganese, is described and suggested as a putative treatment to reduce the oxidative stress that causes neurodegenerative disease. The aim of this narrative review is to explore the evidence that oxidative stress causes neurodegenerative damage and the role of antioxidant genes in inhibiting reactive oxygen species damage. Can the neuronal environment of oxidative stress, causing neuroinflammation and neurodegeneration, be reduced or reversed?

01 Dec 2023·The Lancet. Oncology

Stereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial

Article

Author: Moningi, Shalini ; Katz, Matthew H G ; Thall, Peter F ; Palta, Manisha ; Holmlund, Jon ; Yuan, Ying ; Tzeng, Ching-Wei D ; Beardsley, Robert A ; Kim, Dae Won ; Slack Tidwell, Rebecca S ; Wolff, Robert A ; Herman, Joseph M ; Colbert, Lauren E ; Aguilera, Todd A ; Frakes, Jessica M ; Koay, Eugene J ; Pant, Shubham ; Taniguchi, Cullen M ; Bhutani, Manoop S ; Abi Jaoude, Joseph ; Rebueno, Neal ; Beddar, Sam ; Czito, Brian ; Sawakuchi, Gabriel O ; Das, Prajnan ; Bernard, Vincent ; Malafa, Mokenge ; Ludmir, Ethan B ; Costello, James ; Hoffe, Sarah E ; Mathew, Geena

BACKGROUND:

Stereotactic body radiotherapy (SBRT) has the potential to ablate localised pancreatic ductal adenocarcinoma. Selective dismutase mimetics sensitise tumours while reducing normal tissue toxicity. This trial was designed to establish the efficacy and toxicity afforded by the selective dismutase mimetic avasopasem manganese when combined with ablative SBRT for localised pancreatic ductal adenocarcinoma.

METHODS:

In this adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial, patients aged 18 years or older with borderline resectable or locally advanced pancreatic cancer who had received at least 3 months of chemotherapy and had an Eastern Cooperative Oncology Group performance status of 0-2 were enrolled at six academic sites in the USA. Eligible patients were randomly assigned (1:1), with block randomisation (block sizes of 6-12) with a maximum of 24 patients per group, to receive daily avasopasem (90 mg) or placebo intravenously directly before (ie, within 180 min) SBRT (50, 55, or 60 Gy in five fractions, adaptively assigned in real time by Bayesian estimates of 90-day safety and efficacy). Patients and physicians were masked to treatment group allocation, but not to SBRT dose. The primary objective was to find the optimal dose of SBRT with avasopasem or placebo as determined by the late onset EffTox method. All analyses were done on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, NCT03340974, and is complete.

FINDINGS:

Between Jan 25, 2018, and April 29, 2020, 47 patients were screened, of whom 42 were enrolled (median age was 71 years [IQR 63-75], 23 [55%] were male, 19 [45%] were female, 37 [88%] were White, three [7%] were Black, and one [2%] each were unknown or other races) and randomly assigned to avasopasem (n=24) or placebo (n=18); the placebo group was terminated early after failing to meet prespecified efficacy parameters. At data cutoff (June 28, 2021), the avasopasem group satisfied boundaries for both efficacy and toxicity. Late onset EffTox efficacy response was observed in 16 (89%) of 18 patients at 50 Gy and six (100%) of six patients at 55 Gy in the avasopasem group, and was observed in three (50%) of six patients at 50 Gy and nine (75%) of 12 patients at 55 Gy in the placebo group, and the Bayesian model recommended 50 Gy or 55 Gy in five fractions with avasopasem for further study. Serious adverse events of any cause were reported in three (17%) of 18 patients in the placebo group and six (25%) of 24 in the avasopasem group. In the placebo group, grade 3 adverse events within 90 days of SBRT were abdominal pain, acute cholangitis, pyrexia, increased blood lactic acid, and increased lipase (one [6%] each); no grade 4 events occurred. In the avasopasem group, grade 3-4 adverse events within 90 days of SBRT were acute kidney injury, increased blood alkaline phosphatase, haematoma, colitis, gastric obstruction, lung infection, abdominal abscess, post-surgical atrial fibrillation, and pneumonia leading to respiratory failure (one [4%] each).There were no treatment-related deaths but one late death in the avasopasem group due to sepsis in the setting of duodenal obstruction after off-study treatment was reported as potentially related to SBRT.

INTERPRETATION:

SBRT that uses 50 or 55 Gy in five fractions can be considered for patients with localised pancreatic ductal adenocarcinoma. The addition of avasopasem might further enhance disease outcomes. A larger phase 2 trial (GRECO-2, NCT04698915) is underway to validate these results.

FUNDING:

Galera Therapeutics.

News (Medical) associated with Avasopasem manganese

13 May 2024

·www.globenewswire.com

Galera Reports First Quarter 2024 Financial Results and Recent Corporate Updates

Company’s evaluation of potential strategic alternatives progresses with goal to maximize stockholder valueMALVERN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing 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, 2024, and provided recent corporate updates. "Our review of strategic options continues, as we strive to maximize value for our stockholders," said Mel Sorensen, M.D., Galera’s President and CEO. “Potential options may include mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions and may encompass a potential development path for avasopasem. The process could ultimately culminate in the dissolution of the Company.” General Corporate Updates Galera remains actively engaged with Stifel, Nicolaus & Company, Inc. to undertake a comprehensive review of strategic alternatives for both the Company and its portfolio of dismutase mimetics. The Company has not set a fixed timeline for completing this evaluation process and does not intend to disclose further updates unless and until it is determined that further disclosure is appropriate or necessary.On May 3, 2024, the Company announced that its Board of Directors (the “Board”) unanimously resolved to adopt a limited duration stockholder rights agreement (the “Rights Agreement”) to protect stockholder interests. The Board resolved to adopt the Rights Agreement in response to recent accumulations of the Company’s common stock, and the Rights Agreement is intended to enable all Galera stockholders to realize the full potential value of their investment in Galera and to protect the interests of the Company and its stockholders by reducing the likelihood that any person or group gains control of Galera without paying an appropriate control premium. In addition, the Rights Agreement provides the Board with time to make informed decisions that are in the best long-term interests of Galera and its stockholders. It does not deter the Board from considering any offer or proposal that is fair and otherwise in the best interest of Galera stockholders. First Quarter 2024 Financial Highlights Research and development expenses were $1.5 million in the first quarter of 2024, compared to $7.3 million for the same period in 2023. The decrease was primarily attributable to a decrease in avasopasem and rucosopasem development costs. The Company has ceased all clinical trial activity and suspended the clinical development of its product candidates as it explores potential strategic alternatives.General and administrative expenses were $3.1 million in the first quarter of 2024, compared to $6.6 million for the same period in 2023. The decrease was primarily attributable to the cessation of avasopasem commercial preparations and medical affairs activities and reduced personnel-related expenses due to the workforce reduction announced in August 2023.Galera reported a net loss of $(4.4) million, or $(0.08) per share, for the first quarter of 2024, compared to a net loss of $(17.7) million, or $(0.50) per share, for the same period in 2023.As of March 31, 2024, Galera had cash and cash equivalents of $13.5 million. Galera expects that its existing cash and cash equivalents will enable Galera to fund its operating expenses and capital expenditure requirements into the third quarter of 2025. About Galera Therapeutics Galera Therapeutics, Inc. is a biopharmaceutical company that was historically focused on developing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) was being developed for radiation-induced and cisplatin-related toxicities. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy. The Company’s second product candidate, rucosopasem manganese (rucosopasem), was being developed to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Rucosopasem has been granted orphan drug designation and orphan medicinal product designation by the FDA and EMA, respectively, for the treatment of pancreatic cancer. 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: Galera’s pursuit of strategic alternatives and the ability of any such strategic alternative to provide stockholder value, including a potential development path for avasopasem; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; Galera’s ability to fund its operating expenses and capital expenditure requirements into the third quarter of 2025; and Galera’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics. 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, Orphan Drug or Fast Track Designations 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; 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; environmental, health and safety laws and regulations; Galera may not be able to enter into any desired strategic alternative or partnership on a timely basis, on acceptable terms, or at all; if Galera is unable to secure additional funding or enter into any desired strategic alternative or partnership, it may need to cease operations; risks related to ownership of Galera’s common stock; the possibility of Galera’s common stock being delisted from The Nasdaq Global Market; 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, 2023 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, 2024 2023 Operating expenses: Research and development$1,488 $7,272 General and administrative 3,089 6,609 Loss from operations (4,577) (13,881)Other income (expense), net 196 (3,829)Net loss$(4,381) $(17,710) Net loss per share of common stock, basic and diluted$(0.08) $(0.50)Weighed average common shares outstanding, basic and diluted 54,392,170 35,196,134 Galera Therapeutics, Inc.Selected Consolidated Balance Sheet Data(unaudited, in thousands) March 31, December 31, 2024 2023 Cash and cash equivalents$13,466 $18,257 Total assets 19,651 26,141 Total current liabilities 2,013 4,957 Total liabilities 154,342 157,326 Total stockholders' deficit (134,691) (131,185) Investor Contacts:Christopher DegnanGalera Therapeutics, Inc.610-725-1500cdegnan@galeratx.com William WindhamSolebury Strategic Communications646-378-2946wwindham@soleburystrat.com Media Contact:Timothy BibaSolebury Strategic Communications646-378-2927tbiba@soleburystrat.com

Financial StatementFast TrackBreakthrough TherapyOrphan DrugRadiation Therapy

13 May 2024

·www.biospace.com

Galera Reports First Quarter 2024 Financial Results and Recent Corporate UpdatesCompany’s evaluation of potential strategic alternatives progresses with goal to maximize stockholder value

MALVERN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing 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, 2024, and provided recent corporate updates. "Our review of strategic options continues, as we strive to maximize value for our stockholders," said Mel Sorensen, M.D., Galera’s President and CEO. “Potential options may include mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions and may encompass a potential development path for avasopasem. The process could ultimately culminate in the dissolution of the Company.” General Corporate Updates Galera remains actively engaged with Stifel, Nicolaus & Company, Inc. to undertake a comprehensive review of strategic alternatives for both the Company and its portfolio of dismutase mimetics. The Company has not set a fixed timeline for completing this evaluation process and does not intend to disclose further updates unless and until it is determined that further disclosure is appropriate or necessary. On May 3, 2024, the Company announced that its Board of Directors (the “Board”) unanimously resolved to adopt a limited duration stockholder rights agreement (the “Rights Agreement”) to protect stockholder interests. The Board resolved to adopt the Rights Agreement in response to recent accumulations of the Company’s common stock, and the Rights Agreement is intended to enable all Galera stockholders to realize the full potential value of their investment in Galera and to protect the interests of the Company and its stockholders by reducing the likelihood that any person or group gains control of Galera without paying an appropriate control premium. In addition, the Rights Agreement provides the Board with time to make informed decisions that are in the best long-term interests of Galera and its stockholders. It does not deter the Board from considering any offer or proposal that is fair and otherwise in the best interest of Galera stockholders. First Quarter 2024 Financial Highlights Research and development expenses were $1.5 million in the first quarter of 2024, compared to $7.3 million for the same period in 2023. The decrease was primarily attributable to a decrease in avasopasem and rucosopasem development costs. The Company has ceased all clinical trial activity and suspended the clinical development of its product candidates as it explores potential strategic alternatives. General and administrative expenses were $3.1 million in the first quarter of 2024, compared to $6.6 million for the same period in 2023. The decrease was primarily attributable to the cessation of avasopasem commercial preparations and medical affairs activities and reduced personnel-related expenses due to the workforce reduction announced in August 2023. Galera reported a net loss of $(4.4) million, or $(0.08) per share, for the first quarter of 2024, compared to a net loss of $(17.7) million, or $(0.50) per share, for the same period in 2023. As of March 31, 2024, Galera had cash and cash equivalents of $13.5 million. Galera expects that its existing cash and cash equivalents will enable Galera to fund its operating expenses and capital expenditure requirements into the third quarter of 2025. About Galera Therapeutics Galera Therapeutics, Inc. is a biopharmaceutical company that was historically focused on developing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) was being developed for radiation-induced and cisplatin-related toxicities. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy. The Company’s second product candidate, rucosopasem manganese (rucosopasem), was being developed to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Rucosopasem has been granted orphan drug designation and orphan medicinal product designation by the FDA and EMA, respectively, for the treatment of pancreatic cancer. 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: Galera’s pursuit of strategic alternatives and the ability of any such strategic alternative to provide stockholder value, including a potential development path for avasopasem; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; Galera’s ability to fund its operating expenses and capital expenditure requirements into the third quarter of 2025; and Galera’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics. 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, Orphan Drug or Fast Track Designations 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; 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; environmental, health and safety laws and regulations; Galera may not be able to enter into any desired strategic alternative or partnership on a timely basis, on acceptable terms, or at all; if Galera is unable to secure additional funding or enter into any desired strategic alternative or partnership, it may need to cease operations; risks related to ownership of Galera’s common stock; the possibility of Galera’s common stock being delisted from The Nasdaq Global Market; 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, 2023 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, 2024 2023 Operating expenses: Research and development $ 1,488 $ 7,272 General and administrative 3,089 6,609 Loss from operations (4,577 ) (13,881 ) Other income (expense), net 196 (3,829 ) Net loss $ (4,381 ) $ (17,710 ) Net loss per share of common stock, basic and diluted $ (0.08 ) $ (0.50 ) Weighed average common shares outstanding, basic and diluted 54,392,170 35,196,134 Galera Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited, in thousands) March 31, December 31, 2024 2023 Cash and cash equivalents $ 13,466 $ 18,257 Total assets 19,651 26,141 Total current liabilities 2,013 4,957 Total liabilities 154,342 157,326 Total stockholders' deficit (134,691 ) (131,185 ) Investor Contacts: Christopher Degnan Galera Therapeutics, Inc. 610-725-1500 cdegnan@galeratx.com William Windham Solebury Strategic Communications 646-378-2946 wwindham@soleburystrat.com Media Contact: Timothy Biba Solebury Strategic Communications 646-378-2927 tbiba@soleburystrat.com

Financial StatementBreakthrough TherapyFast TrackOrphan DrugRadiation Therapy

03 May 2024

·www.biospace.com

Galera Adopts Limited Duration Stockholder Rights Agreement - May 03, 2024

MALVERN, Pa., May 03, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that its Board of Directors (the “Board”) has unanimously resolved to adopt a limited duration stockholder rights agreement (the “Rights Agreement”) to protect stockholder interests. The Board resolved to adopt the Rights Agreement in response to recent accumulations of the Company’s common stock and the Rights Agreement is intended to enable all Galera stockholders to realize the full potential value of their investment in the company and to protect the interests of the company and its stockholders by reducing the likelihood that any person or group gains control of Galera without paying an appropriate control premium. In addition, the Rights Agreement provides the Board with time to make informed decisions that are in the best long-term interests of Galera and its stockholders. It does not deter the Board from considering any offer or proposal that is fair and otherwise in the best interest of Galera stockholders. In connection with the Rights Agreement, Galera will issue, by means of a dividend, one preferred share purchase right for each outstanding share of Galera common stock to stockholders of record as of the close of business on May 20, 2024. Initially, these rights will not be exercisable and will trade with, and be represented by, the shares of Galera common stock. The Rights Agreement has an expiration date of May 2, 2025, and the Board will consider whether to terminate the Rights Agreement earlier than such date if warranted. The Rights Agreement is similar to other rights plans adopted by publicly-held companies. Under the Rights Agreement, the rights generally become exercisable only if a person or group (each, an “acquiring person”) acquires beneficial ownership of ten percent (10%) or more of the outstanding shares of Galera common stock in a transaction not approved by the Board. In that situation, each holder of a right (other than the acquiring person, whose rights will become void and will not be exercisable) will be entitled to purchase, at the then-current exercise price, additional shares of Galera common stock at a fifty percent (50%) discount. In addition, the rights also become exercisable if Galera is acquired in a merger or other business combination after an unapproved party acquires more than ten percent (10%) of the outstanding shares of Galera common stock. The Board, at its option, may exchange each right (other than rights owned by the acquiring person that have become void) in whole or in part, at an exchange ratio of one share of Galera common stock per outstanding right, subject to adjustment. Except as provided in the Rights Agreement, the Board is entitled to redeem the rights at $0.001 per right. If a person or group that beneficially owns ten percent (10%) or more of the outstanding shares of Galera common stock prior to Galera’s announcement of its adoption of the Rights Agreement, then that person’s or group’s existing ownership percentage will be grandfathered at their current ownership levels, although, with certain exceptions, the rights will become exercisable for stockholders other than that person or group, if at any time after the announcement of the adoption of the Rights Agreement such person or group increases its ownership of Galera common stock. Additional information regarding the Rights Agreement will be contained in a current report on Form 8-K to be filed by Galera with the U.S. Securities and Exchange Commission. Sidley Austin LLP is acting as legal counsel to Galera. About Galera Therapeutics, Inc. Galera Therapeutics, Inc. is a biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) has been in development for radiation-induced and cisplatin-related toxicities. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy. The Company’s second product candidate, rucosopasem manganese (rucosopasem), has been in 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. Rucosopasem has been granted orphan drug designation and orphan medicinal product designation by the FDA and EMA, respectively, for the treatment of pancreatic cancer. Galera is headquartered in Malvern, PA. Investor Contacts: Christopher Degnan Galera Therapeutics, Inc. 610-725-1500 cdegnan@galeratx.com William Windham Solebury Strategic Communications 646-378-2946 wwindham@soleburystrat.com

Fast TrackOrphan Drug

100 Deals associated with Avasopasem manganese

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
radiation oral mucositis	NDA/BLA	US	Galera Therapeutics, Inc.	12 Dec 2022
ulcerative oral mucositis due to radiation	NDA/BLA	US	Galera Therapeutics, Inc.	-
COVID-19	Phase 2	US	Galera Therapeutics, Inc.	09 Sep 2020
Critical Illness	Phase 2	US	Galera Therapeutics, Inc.	09 Sep 2020
Esophagitis	Phase 2	US	Galera Therapeutics, Inc.	19 Dec 2019
Lung Cancer	Phase 2	US	Galera Therapeutics, Inc.	19 Dec 2019
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	US	Galera Therapeutics, Inc.	12 Feb 2018
Squamous Cell Carcinoma of Head and Neck	Phase 1	US	Galera Therapeutics, Inc.	01 Aug 2013
Squamous cell carcinoma of the oral cavity	Phase 1	US	Galera Therapeutics, Inc.	01 Aug 2013
Squamous Cell Carcinoma of the Oropharynx	Phase 1	US	Galera Therapeutics, Inc.	01 Aug 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03340974 (CTgov)	Phase 1/2	Locally Advanced Pancreatic Adenocarcinoma	42	Stereotactic Radiation Therapy (SBRT) 50 Gy	wqiwzukqtk(pkqkhpdkkk) = ejxnuyumpa ehumupgwhd (gqlhqbpywp, zwkhjwvknv - bppocxbjmv) View more	-	15 Dec 2023
ROMAN, GT-201 (ESMO2023)	Phase 2/3	Locally Advanced Head and Neck Squamous Cell Carcinoma	551	Avasopasem manganese 90mg	dilevifoas(miavcgmixe) = zmywqjwxjb usbqhqfpnk (ghmmkgovzp ) View more	Positive	22 Oct 2023
				Placebo	dilevifoas(miavcgmixe) = ncmwaqnbsn usbqhqfpnk (ghmmkgovzp ) View more
NCT03689712 (ROMAN, ASCO2023) Manual	Phase 3	Chronic Kidney Diseases	407	avasopasem manganese	edqjlglncl(vnicnaucjv) = blfxzbwrfz ekrceqqffd (ibnumhasgn ) View more	Positive	26 May 2023
				placebo	edqjlglncl(vnicnaucjv) = bxioxyzsvn ekrceqqffd (ibnumhasgn ) View more
NCT03689712 (ROMAN, ASCO2022) Manual	Phase 3	Locally Advanced Malignant Neoplasm \| Stomatitis	407	Intensity-modulated radiotherapy+Cisplatin+Avasopasem	ojfbrtuxdy(iyyehwjiye) = hduuvtvwln ztsjswqpju (izwozjaxhx ) View more	Positive	02 Jun 2022
				Intensity-modulated radiotherapy+Cisplatin+placebo	ojfbrtuxdy(iyyehwjiye) = vbsqypnpuw ztsjswqpju (izwozjaxhx ) View more
NCT04225026 (AESOP, GlobeNewswire) Manual	Phase 2	Esophagitis	39	Avasopasem manganese	ysfidajjqu(snmppztuot) = 17% (grade 2)；3% (grade 3) sgewblloak (txabjcpqwu ) View more	Positive	02 May 2022
NCT04555096 (CTgov)	Phase 2	Critical Illness \| COVID-19	16	GC4419 (Active GC4419)	yrnlgzwrwf(iefhzixyfg) = ailvkpuogs ytzxslnybq (iyctgjogbz, wcjwbddmoq - csmyippreg) View more	-	18 Mar 2022
				placebo (Placebo)	yrnlgzwrwf(iefhzixyfg) = fwtvmcguir ytzxslnybq (iyctgjogbz, ensvmxxpmv - ssxkohimpl) View more
NCT03689712 (ROMAN, Corporate Publications) Manual	Phase 3	Stomatitis	-	avasopasem manganese	bdmngzlwoj(gbfbpxarpp) = gfncadlcte jwumxsczgi (pjawgdlbyr ) View more	Negative	19 Oct 2021
				Placebo	bdmngzlwoj(gbfbpxarpp) = xcrhhpeltj jwumxsczgi (pjawgdlbyr ) View more
NCT03340974 (GlobeNewswire) Manual	Phase 1/2	Locally Advanced Pancreatic Adenocarcinoma	42	stereotactic body radiation therapy+GC4419	dddiweikym(aukgpjnxcy) = wkhxhwlirc ccmwswirhk (lihvpdlxav ) View more	Positive	27 Oct 2020
				stereotactic body radiation therapy+Placebo	dddiweikym(aukgpjnxcy) = ariponggxe ccmwswirhk (lihvpdlxav ) View more
NCT03340974 (Corporate Publications) Manual	Phase 1/2	Locally Advanced Pancreatic Adenocarcinoma	42	GC4419	qsunrnhscd(zcrgmkrfnj) = no significant differences ygjjmpqfmh (jpoxflmbel ) View more	Positive	27 Oct 2020
				Placebo
NCT03689712 (ROMAN, ASCO2020)	Phase 3	Locally Advanced Malignant Neoplasm	335	GC4419 90 mg	uhmuygildm(bzeoxcawbb) = rndkitjvrl teiqshgllc (jmierpbmev ) View more	Positive	25 May 2020
				Placebo	uhmuygildm(bzeoxcawbb) = qdfjyqnhqq teiqshgllc (jmierpbmev ) View more

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