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.

NCT04225026 / TerminatedPhase 2

A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer

GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.

Start Date19 Dec 2019

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.

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 Jan 2025·Advances in Radiation Oncology

Benefit of Avasopasem Manganese on Severe Oral Mucositis in Head and Neck Cancer in the ROMAN Trial: Unplanned Secondary Analysis

Article

Author: Kennedy, Eugene ; Salvaggio, Samuel ; Anderson, Carryn ; De Backer, Mickaël ; Walker, Gary ; Buyse, Marc ; Schoen, Benton ; Beardsley, Robert ; Chiem, Jean-Christophe ; Dunlap, Neal ; Lee, Christopher M ; Saunders, Deborah

Purpose:

Oral mucositis (OM) is a debilitating side effect of cisplatin and intensity-modulated radiation therapy (IMRT) in patients with head and neck cancer. The phase 3 ROMAN trial showed avasopasem manganese (AVA) significantly decreased individual endpoints of incidence and duration of severe oral mucositis (SOM, World Health Organization [WHO] grade 3-4), with nominal decrease in severity (WHO grade 4) and significant increase in the delay in onset of SOM. We sought to determine the Net Treatment Benefit (NTB) of AVA versus placebo (PBO) using the generalized pairwise comparisons (GPC) method.

Methods and Materials:

GPC is a statistical method that permits simultaneous analysis of several prioritized outcomes, comparing all possible pairs of a patient in the active (ie, AVA) group and a patient from the control (ie, PBO) group. NTB is the net benefit across all the outcomes for AVA compared to PBO. Key clinically relevant outcomes from ROMAN were prioritized: (1) WHO grade 4 OM incidence; (2) SOM incidence; (3) days of SOM; (4) days to SOM onset, with 7 days difference defined as the clinical relevance threshold for SOM days and SOM onset.

Results:

GPC analysis of 407 patients (AVA = 241, placebo = 166) stratified by cisplatin schedule and treatment setting resulted in 13,969 pairwise comparisons. AVA showed statistically significant net benefit on all 4 key outcomes with a 53.9% probability that AVA would benefit patients versus a 35.0% probability that PBO would; the difference between these probabilities was a NTB of 18.9% (P = .0012), translating to an AVA number needed to treat of 5.3 patients. All outcomes contributed to NTB, reflecting improvements in SOM incidence, onset and duration, and in grade 4 OM incidence seen in the original ROMAN analysis.

Conclusions:

This GPC analysis shows compelling evidence from the ROMAN trial of AVA's clinical benefit across key parameters of SOM burden.

01 May 2024·DRUG DEVELOPMENT RESEARCH

Comparisons of successful and failed Phase III trials of drugs and biologicals tested for mitigation of oral mucositis in patients being treated with radiotherapy with or without concomitant chemotherapy for cancers of the head and neck

Article

Author: Sonis, Stephen T. ; Liang, Lang

Abstract:

Oral mucositis (OM) remains a significant toxicity among patients being treated with radiotherapy (RT) alone or with concomitant chemotherapy (CRT) for cancers of the head and neck (HNC). Given its clinical significance as an unmet need and its potential commercial viability, the pharmaceutical industry has been actively pursuing an effective intervention. Despite this interest and activity, only a few agents have been studied in Phase III trials (n = 6). The objective of this study was to identify common features that differentiate successful and failed Phase III OM trials. We used the United States Patent and Trademark Office Patent Public Search database to search patents with “oral mucositis” in the claims. We then searched ClinicalTrials.gov and PubMed to determine if Phase III or Phase II trial data for identified biologics/drugs had been published. We assessed each Phase III and Phase II trial for characteristics that may be associated with trial success or failure. We considered a study as a “success” if the primary endpoint reached statistical significance, and we considered a study as “failure” if the primary endpoint did not reach statistical significance. Of the three successful Phase III trials, one investigated avasopasem manganese (Galera Therapeutics) and two examined palifermin (Amgen). The three failed trials included those evaluating dusquetide (Soligenix), iseganan hydrochloride (IntraBiotics Pharmaceuticals), and clonidine (Monopar Therapeutics). We found that differences in the level of sponsor funding, patient inclusion criteria including radiation source and concomitant chemotherapy regimen, and concordance of primary efficacy outcomes between Phase II and Phase III trials influenced outcomes. To properly design clinical trials for OM in HNC patients, it is important that researchers and sponsors take note of specific study characteristics associated with success or failure, particularly with Phase III trials where the risks and costs are the highest.

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.

News (Medical) associated with Avasopasem manganese

14 Aug 2024

·www.fiercebiotech.com

Gone are the days of Galera: Biotech says goodbye to staffers and initiates wind-down

The liquidation plans come almost exactly a year after the FDA denied approval for Galera’s radiotherapy complication drug avasopasem. Galera Therapeutics is shuttering, with the biotech’s board OK'ing a liquidation plan that whittles down the company’s workforce to just three people.The clinical-stage company—which was working on therapeutics designed to improve the radiotherapy process for oncology patients—will ask for stockholder approval of the dissolution in October, according to a second-quarter earnings release shared Aug. 14.The move follows “extensive consideration of potential strategic alternatives” over the past year, Galera President and CEO Mel Sorensen, M.D., said in the release.Back in August 2023, the FDA rejected approval for Galera’s radiotherapy complication drug, dubbed avasopasem. The agency deemed that the phase 3 results were “not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer,” according to a Galera release last year. Instead, the FDA asked for a new trial to be conducted before Galera could resubmit the application for avasopasem, a selective dismutase mimetic. The investigational candidate had snagged both FDA fast-track and breakthrough designations for reducing severe oral mucositis tied to radiotherapy. The biotech, which had been building out a commercial leadership team in preparation for an anticipated U.S. drug launch, then jettisoned 70% of its employees. The company also stopped all clinical trial activity as it evaluated strategic alternatives—including partnering—for avasopasem and rucosopasem, a second asset designed to help patients receiving radiotherapy for non-small cell lung cancer or locally advanced pancreatic cancer. Galera will continue to assess possible sale options for its assets while preparing for the potential dissolution, according to the company. In the meantime, the business is shedding all staff but three by the end of August. The remaining workers will be current Chief Financial Officer Chris Degnan, Chief Legal and Compliance Officer Jennifer Stacey and Sorensen. The former two will transition out of their roles at the end of August and enter consulting agreements with Galera to guide the wind-down. As of June 30, Galera had $10.7 million on hand, money that’s expected to carry the company for at least 12 months, including through the dissolution process.

Phase 3Fast TrackDrug Approval

14 Aug 2024

·www.globenewswire.com

Galera Announces Board Approval of Complete Liquidation and Dissolution

Company reports second quarter 2024 financial resultsMALVERN, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company historically 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 has approved a Plan of Liquidation and Dissolution (Plan of Dissolution), which provides for the dissolution of the Company under Delaware law, and plans to seek stockholder approval of the Plan of Dissolution at a special meeting of stockholders to be held on or around October 17, 2024. If the Plan of Dissolution is approved by the Company’s stockholders, the Company intends to file a certificate of dissolution with the Delaware Secretary of State and distribute all remaining cash, including any proceeds from the potential sale of any pipeline assets, to stockholders, subject to first completing the wind down of the Company’s operations and paying or providing for the Company’s creditors and potential liabilities (the Dissolution). The Board may also, in its sole discretion, decide to delay the filing or not file the certificate of dissolution. The Company also announced financial results for the second quarter ended June 30, 2024. "Following extensive consideration of potential strategic alternatives for the Company for close to a year and in order to maximize stockholder value, the Board of Directors has unanimously voted to approve and recommend for the stockholders to approve the Plan of Dissolution," said Mel Sorensen, M.D., Galera’s President and CEO. “On behalf of the management team, we extend our appreciation to all the patients, the clinical trial staff, our employees, the Board of Directors and our investors who have supported Galera throughout its journey.” Corporate Update As previously reported, the Company had engaged Stifel, Nicolaus & Company, Inc., as its financial advisor, to assist in reviewing strategic alternatives with the goal of maximizing value for its stockholders. The Board has determined that there are no suitable options available to the Company at this time. However, the Company will continue to evaluate potential sale options for its pipeline assets while it continues to prepare for the planned Dissolution and, in the event that the Company is successful in a sale of any of its pipeline assets, the proceeds would be distributed to stockholders in accordance with the Plan of Dissolution. Moreover, in order to further reduce costs, the Company will reduce its workforce to three remaining employees, effective as of August 31, 2024, when the positions of Chief Financial Officer, held by Chris Degnan, and Chief Legal & Compliance Officer, held by Jennifer Evans Stacey, will be eliminated. Mel Sorensen will continue to serve as the Company’s President and Chief Executive Officer through the transition to Development Specialists, Inc., the firm engaged by the Company to help with the wind-up activities and administration of the Plan of Dissolution. The Company expects to enter into consulting agreements with Mr. Degnan and Ms. Stacey pursuant to which they will continue to provide services to the Company in furtherance of its wind-up activities. Second Quarter 2024 Financial Results Research and development expenses were $1.4 million in the second quarter of 2024, compared to $7.6 million for the same period in 2023. The decrease was primarily attributable to a decrease in avasopasem and rucosopasem development costs and reduced personnel-related expenses due to the workforce reduction announced in August 2023. The Company ceased all clinical trial activity and suspended the clinical development of its product candidates as it explored potential strategic alternatives.General and administrative expenses were $2.8 million in the second quarter of 2024, compared to $9.2 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 $(4.1) million, or $(0.07) per share, for the second quarter of 2024, compared to a net loss of $(20.7) million, or $(0.48) per share, for the same period in 2023.As of June 30, 2024, Galera had cash and cash equivalents of $10.7 million. Galera expects that its existing cash and cash equivalents will enable Galera to fund its operating expenses, including costs related to the Dissolution, for at least the next twelve months. 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 plans and expectations regarding its Plan of Dissolution and the timing thereof; Galera’s ability to sell or otherwise dispose of any of its remaining assets in Dissolution and the timing thereof; Galera’s ability to make liquidating distributions and the timing thereof; the timing of management transitions; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; Galera’s ability to fund its operating expenses for at least the next twelve months. 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’s ability to receive stockholder approval of Dissolution; Galera’s ability to sell or otherwise dispose of any of its remaining assets in Dissolution; Galera’s ability to make liquidating distributions and the timing thereof; the impact of general economic conditions on its business and operations; 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, 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. Stockholder Approval The Company intends to file a proxy statement with respect to a special meeting of the Company’s stockholders, at which meeting the Company’s stockholders will be asked to, among other items, consider and approve the Plan of Dissolution. Additional Information About the Dissolution and Where to Find It This communication is being made in respect of the proposed Plan of Dissolution. Galera expects to file with the SEC a definitive proxy statement and other relevant documents in connection with the Plan of Dissolution. The definitive proxy statement will be sent or given to the stockholders of Galera and will contain important information about the proposed Plan of Dissolution and related matters. INVESTORS AND STOCKHOLDERS OF GALERA ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT AND OTHER RELEVANT MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT GALERA AND THE PLANNED DISSOLUTION. Investors may obtain a free copy of these materials (when they are available) and other documents filed by Galera with the SEC at the SEC’s website at www.sec.gov. Participants in the Solicitation Galera and certain of its directors, executive officers and other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed Plan of Dissolution. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of Galera’s stockholders in connection with the proposed Plan of Dissolution will be set forth in Galera’s definitive proxy statement for its stockholder meeting at which the proposed Plan of Dissolution will be submitted for approval by Galera’s stockholders. You may also find additional information about Galera’s directors and executive officers in Galera’s Annual Report on Form 10-K for the year ended December 31, 2023, and in subsequently filed Current Reports on Form 8-K and Quarterly Reports on Form 10-Q. 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, 2024 2023 2024 2023 Operating expenses: Research and development$1,430 $7,561 $2,918 $14,833 General and administrative 2,779 9,246 5,868 15,855 Loss from operations (4,209) (16,807) (8,786) (30,688)Other income (expense), net 145 (3,905) 341 (7,734)Net loss$(4,064) $(20,712) $(8,445) $(38,422) Net loss per share of common stock, basic and diluted$(0.07) $(0.48) $(0.16) $(0.98)Weighted average common shares outstanding, basic and diluted 54,392,170 42,916,962 54,392,170 39,077,876 Galera Therapeutics, Inc.Selected Consolidated Balance Sheet Data(unaudited, in thousands) June 30, December 31, 2024 2023 Cash and cash equivalents$10,749 $18,257 Total assets 16,383 26,141 Total current liabilities 2,126 4,957 Total liabilities 154,415 157,326 Total stockholders' deficit (138,032) (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

Fast TrackFinancial StatementBreakthrough TherapyExecutive ChangeOrphan Drug

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

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
Small Cell 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

Clinical Result

Indication

Phase

Evaluation

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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	vancjklgsn(vwmqcmqjvy) = nauwypmrqp dvtfmiadks (zxzugwqnbp, kowswdigyv - vrbrdguuef) View more	-	15 Dec 2023
ROMAN, GT-201 (ESMO2023)	Phase 2/3	Locally Advanced Head and Neck Squamous Cell Carcinoma	551	Avasopasem manganese 90mg	qpxqyhqekz(efgspwqsej) = vgqpqpmpgj gwdhntnfvh (rwfiyzrhrf ) View more	Positive	22 Oct 2023
				Placebo	qpxqyhqekz(efgspwqsej) = uhvwmikbha gwdhntnfvh (rwfiyzrhrf ) View more
NCT03689712 (ROMAN, ASCO 12023 \| ASCO 22023) Manual	Phase 3	Chronic Kidney Diseases	407	avasopasem manganese	yrqvundtvs(rlhngwlmaf) = updjogsiff ctdyaxfmwf (ijuosuwexy ) View more	Positive	26 May 2023
				placebo	yrqvundtvs(rlhngwlmaf) = igkyvwgrhn ctdyaxfmwf (ijuosuwexy ) View more
NCT03689712 (ROMAN \| Phase IIb, CTgov)	Phase 3	radiation oral mucositis	455	Placebo	gevyeyfcpn(cvtfxvjutl) = eukwnvkaxj lnscxijolp (meifvfxhui, ibkgruzsdd - ofoxqmrvfq) View more	-	13 Apr 2023
NCT04225026 (AESOP, CTgov)	Phase 2	Lung Cancer \| Small Cell Lung Cancer \| Esophagitis	39	GC4419 (avasopasem manganese)	zexbaexlej(zmvcbgfvmo) = rpwhlcsvuq uzgwkedoun (pwtdeklwyv, tfnouftkib - dksugiiapi) View more	-	23 Mar 2023
NCT03689712 (ROMAN, ASCO2022) Manual	Phase 3	Stomatitis \| Head and Neck Neoplasms	407	Intensity-modulated radiotherapy+Cisplatin+Avasopasem	aunehmjuvy(ahrpbbxmiz) = fdahwfwgnr soqokcrhcg (giblqmmkyt ) View more	Positive	02 Jun 2022
				Intensity-modulated radiotherapy+Cisplatin+placebo	aunehmjuvy(ahrpbbxmiz) = fvmmjlphvm soqokcrhcg (giblqmmkyt ) View more
NCT04225026 (AESOP, GlobeNewswire) Manual	Phase 2	Esophagitis	39	Avasopasem manganese	shrgtmekri(arbnndifdo) = 17% (grade 2)；3% (grade 3) luspqqxwmx (iraukpxnjn ) View more	Positive	02 May 2022
NCT04555096 (CTgov)	Phase 2	COVID-19 \| Critical Illness	16	GC4419 (Active GC4419)	ttjwcxkple(qyffpluxjl) = wivekwqnlj gaupeodtdg (ujsbwpxgij, vngwtzzqrt - fmonwymrsv) View more	-	18 Mar 2022
				Placebo (Placebo)	ttjwcxkple(qyffpluxjl) = dzhyivjhwm gaupeodtdg (ujsbwpxgij, rpxdodjzkh - nuovzhxfws) View more
NCT03689712 (ROMAN, Corporate Publications) Manual	Phase 3	Stomatitis	-	avasopasem manganese	pdknfejbpf(wehsdrffzi) = wtswyhntkd seyzadbnri (yipgbhwgua ) View more	Negative	19 Oct 2021
				Placebo	pdknfejbpf(wehsdrffzi) = nfhunzppdd seyzadbnri (yipgbhwgua ) View more
NCT03340974 (Corporate Publications) Manual	Phase 1/2	Locally Advanced Pancreatic Adenocarcinoma	42	GC4419	jirchpdijy(afrtixtnop) = no significant differences qynkbruiqe (vmeycctkne ) View more	Positive	27 Oct 2020
				Placebo

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