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.

NCT04529850

/ CompletedPhase 2

An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

Start Date30 Jun 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.

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 Feb 2025·CANCER TREATMENT REVIEWS

Managing strategies of chemotherapy and radiotherapy-induced oral mucositis

Review

Author: Li, Chunyu ; Chen, Qianming ; Jiang, Yuchen ; Liu, Xiangfei ; Shi, Wenjin ; Qiu, Yan ; Luo, Xiaobo ; Wu, Yuqi

Radiotherapy and chemotherapy are widely employed as primary non-surgical cancer treatments; however, their non-selective cytotoxicity often leads to adverse events such as oral mucositis (OM), particularly in head and neck cancer therapies. International guidelines provide recommendations for managing chemoradiotherapy-induced OM in various clinical contexts. Subsequently, emerging researches have introduced evidence supporting novel approaches or existing regimens for OM prevention and treatment. The repurposing of established drugs has garnered significant interest due to its shorter development timeline, improved safety profiles, and lower costs compared to new drug development. For example, clinical trials assessing established drugs such as melatonin, clonidine, and pentoxifylline indicate promising potential for managing OM. Additionally, several emerging pharmacological interventions have demonstrated considerable efficacy; SAMITAL and rhIL-11 are supported by phase II clinical trials and prospective studies, while probiotics like Streptococcus salivarius K12 and curcumin have shown effectiveness in randomized clinical trials. Furthermore, recent high-level studies have reinforced the efficacy of non-pharmacological interventions, such as photobiomodulation (PBM) and cryotherapy, over the past two years. In all, given the evidence supporting different strategies, PBM and oral cryotherapy are highly recommended for managing OM when feasible. Topical clonidine, melatonin, oral pentoxifylline, topical SAMITAL or rhIL-11, oral SsK12, and curcumin may also be utilized but would benefit from validation in larger trials. Besides, Verbascoside, Palifermin, Amifostine, and Avasopasem manganese can be suggested for OM management, while the side effects should be monitored. The accessibility and cost/effectiveness of specific managing strategies of OM should be considered when selecting appropriate options.

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.

News (Medical) associated with Avasopasem manganese

05 Jan 2025

·www.globenewswire.com

Galera Therapeutics completes acquisition of Nova Pharmaceuticals

Galera’s development strategy shifts from toxicity reduction to anti-cancer therapeutics, with three trials in patients with highly resistant subsets of advanced breast cancer. Lead program is Phase 1/2 trial of Nova Pharmaceutical’s Clinical Stage Nitric Oxide Synthase (NOS) Inhibitor on top of standard-of-care nab-paclitaxel and alpelisib in metaplastic breast cancer. Concurrent financing when added to Galera’s existing cash balance, is anticipated to fund operations through data readout of its lead program and into 2026. Galera intends to leverage NCI grants, academic partnerships and the I-SPY 2 network for efficient and cost-effective clinical dataset expansion. Dec. 31, 2024 -- Galera Therapeutics, Inc. (OTC: GRTX) announced today it has completed the acquisition of Nova Pharmaceuticals, Inc. (“Nova”), a privately held biotechnology company advancing a pan-NOS Inhibitor to treat patients with highly resistant forms of breast cancer, including metaplastic breast cancer and other refractory subsets of triple-negative breast cancer (“TNBC”). In support of the acquisition, a syndicate of investors led by Ikarian Capital has invested approximately $3 million to purchase Galera common stock. Galera’s new lead program is the Investigator-sponsored Phase 1/2 trial of a pan-NOS Inhibitor on top of standard-of-care nab-paclitaxel and alpelisib in metaplastic breast cancer. The Company’s cash balance at closing is anticipated to fund operations into 2026 and through data readout from its lead program in metaplastic breast cancer. A second trial is planned for this agent in TNBC in collaboration with the I-SPY 2 consortium. The Company intends to support a third trial of Avasopasem, one of its small molecule dismutase mimetics, in patients with hormone-receptor positive (HR+) advanced breast cancer who have become resistant to conventional therapy. This trial is expected to commence enrollment in the first half of 2025. “Dismutase Mimetics and NOS inhibitors involve complementary pathways that play important roles in cancer, in the tumor microenvironment, in resistance to conventional chemoradiotherapy and in immuno-oncology,” said Mel Sorensen, M.D., President & CEO of Galera. “Substantial mechanistic and preclinical rationale for both agents in solid tumors, especially in breast cancer, has been generated by the companies and their collaborators. Both product candidates are in clinical stage development, having been well-characterized in many patients both in oncologic and non-oncologic indications. Galera has decided to focus its near-term development on the hardest-to-treat subsets of advanced breast cancer.” The Company continues as Galera Therapeutics, Inc. (OTC:GRTX) and will be led by Dr. Sorensen, as President and Chief Executive Officer and Joel Sussman, as Chief Accounting Officer. A team of consultants comprising people from both Galera and Nova will manage the R&D of the company, in a capital efficient manner. “I am excited about the ability to combine our technologies to address the unmet need of many breast cancer patients,” said Par S Hyare CEO of Nova Pharmaceuticals. “This agreement allows Galera and our collaborators the opportunity to advance our product candidates to the next stage of clinical development. The investigators at Houston Methodist have presented data showing several responses in the ongoing trial and we look forward to the data readout in the next nine to fifteen months under the capable leadership of Galera’s team.” Under the terms of the merger agreement and the securities purchase agreement, Galera has issued approximately 21.1 million shares of common stock plus pre-funded warrants exercisable for approximately 23 million shares of common stock, and approximately 119,318 shares of Series B non-voting (1:1000) convertible preferred stock in a private placement. At the closing, Galera stockholders will own approximately 55.2% of the common shares (assuming that the pre-funded warrants are exercised in full). The shares of Series B non-voting convertible preferred stock will be convertible into shares of common stock, subject to stockholder approval at a subsequent meeting of the Company’s stockholders. Following that approval, on an as-converted basis, the pre-acquisition Galera stockholders will own approximately 25% of the combined Company and the new investors and Nova stockholders will own approximately 75% of the combined Company (assuming that the pre-funded warrants are exercised in full). The transaction was unanimously approved by the Board of Directors of both companies and by the stockholders of Nova. The Board of Directors includes three current Galera board members, Mr. Larry Alleva and Mr. Kevin Lokay and Dr. Sorensen, and two additional board members selected by Nova, Mr. Michael Friedman and Dr. Nancy T. Chang. Mr. Friedman has an MBA from the University of Chicago and brings over 20 years’ experience in investment banking, in finance and in the life science industry to the Board of Galera. Dr. Chang is a PhD biochemist who has spent her career in leadership roles in academia, in large and small pharma companies and in the venture capital world and she has extensive experience in biopharma boards. Stifel, Nicolaus & Company served as the financial advisor to Galera. Lucid Capital Markets, LLC has provided a fairness opinion to Galera's Board of Directors. Sidley Austin LLP is serving as legal counsel to Galera. Cooley LLP is serving as legal counsel to Nova. Galera Therapeutics, Inc. is a biopharmaceutical company with a portfolio of small molecule superoxide dismutase mimetics. It was historically focused on developing these agents in combination with chemoradiotherapy to reduce the toxicities of the conventional regimens in patients with head and neck cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy and has demonstrated toxicity reduction in phase 2 and 3 trials. Dismutase mimetics also have a well-developed mechanistic role in anti-cancer therapeutics in preclinical studies, and Galera completed a pilot of avasopasem combined with stereotactic radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (Taniguchi, Cullen M et al. The Lancet Oncology, Volume 24, Issue 12, 1387 – 1398). Nova Pharmaceuticals is a clinical stage biotechnology company focused on targeting the molecular mechanisms driving resistance to current treatments in triple negative and metaplastic breast cancer and improving outcomes for patients. Nova Pharmaceuticals’ pan-nitric oxide synthase (NOS) inhibitor is currently being studied in a Phase 1/2 study at Houston Methodist Hospital and has completed a Phase 1/2 study in triple negative breast cancer patients. The content above comes from the network. if any infringement, please contact us to modify.

Executive ChangeFast Track

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

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	United States	Galera Therapeutics, Inc.	12 Dec 2022
ulcerative oral mucositis due to radiation	NDA/BLA	United States	Galera Therapeutics, Inc.	-
COVID-19	Phase 2	United States	Galera Therapeutics, Inc.	09 Sep 2020
Critical Illness	Phase 2	United States	Galera Therapeutics, Inc.	09 Sep 2020
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Belgium	Galera Therapeutics, Inc.	30 Jun 2020
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Czechia	Galera Therapeutics, Inc.	30 Jun 2020
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Germany	Galera Therapeutics, Inc.	30 Jun 2020
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Poland	Galera Therapeutics, Inc.	30 Jun 2020
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Spain	Galera Therapeutics, Inc.	30 Jun 2020
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Switzerland	Galera Therapeutics, Inc.	30 Jun 2020

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	vhuarzgrjm = xvgogsiifh zghcyopcuk (wfgzqebrwi, scddfvsowp - xrqipdzdyz) View more	-	15 Dec 2023
NCT02508389 \| NCT03689712 (ROMAN, GT-201, ESMO2023)	Phase 2/3	Locally Advanced Head and Neck Squamous Cell Carcinoma	551	Avasopasem manganese 90mg	fsxrajlvnp(wksmgetibo) = nwmiraadpr anuogiopal (cemwwsygjh ) View more	Positive	22 Oct 2023
NCT02508389 \| NCT03689712 (ROMAN, GT-201, ESMO2023)	Phase 2/3	Locally Advanced Head and Neck Squamous Cell Carcinoma	551	Placebo	fsxrajlvnp(wksmgetibo) = vuwhfhoyww anuogiopal (cemwwsygjh ) View more	Positive	22 Oct 2023
NCT03689712 (ROMAN, ASCO 12023 \| ASCO 22023) Manual	Phase 3	Chronic Kidney Diseases	407	avasopasem manganese	woldoalyeo(ivtpefocig) = gqaswrlgmd eqfwtzotrn (fsoejzhcgw ) View more	Positive	26 May 2023
NCT03689712 (ROMAN, ASCO 12023 \| ASCO 22023) Manual	Phase 3	Chronic Kidney Diseases	407	placebo	woldoalyeo(ivtpefocig) = dqaqunsxrb eqfwtzotrn (fsoejzhcgw ) View more	Positive	26 May 2023
NCT03689712 (ROMAN \| Phase IIb, CTgov)	Phase 3	radiation oral mucositis	455	Placebo	cdrsyeclmg = gipkmsbopz wnxrrzuvra (tsosuxmrfx, pgqupdpsxs - tmzuvyspia) View more	-	13 Apr 2023
NCT04225026 (AESOP, CTgov)	Phase 2	Lung Cancer \| Small Cell Lung Cancer \| Esophagitis	39	GC4419 (avasopasem manganese)	tuxlyriptn = dxpkzxdfba jrkvabwzsd (kovqfpqrob, aukuwkpmfh - jmxuhoizld) View more	-	23 Mar 2023
NCT04529850 (AESOP, ASTRO2022)	Phase 2	Esophagitis	39	Avasopasem Manganese (GC4419) 90 mg	iysyumowgh(kydxbrkadv) = 21% of patients experienced dizziness wuzzkrnxlj (frdvezkwqt ) View more	Positive	01 Nov 2022
NCT04529850 (AESOP, CTgov)	Phase 2	Otitis Media With Effusion \| Stomatitis \| Locally Advanced Head and Neck Squamous Cell Carcinoma ... View more	38	Intensity-modulated radiation therapy (IMRT)+cisplatin+Drug: GC4419	wvmrgsqtwi = wwakzhcpkt zjhpnaeyow (ztpmzjyhez, tdwfjuwtqp - iqgwurulin) View more	-	16 Aug 2022
NCT03689712 (ROMAN, ASCO2022) Manual	Phase 3	Stomatitis \| Head and Neck Neoplasms	407	Intensity-modulated radiotherapy+Cisplatin+Avasopasem	bbojcehqjo(kfljzgawhv) = zefgbxxjea mysrglqlmy (lwvyrweink ) View more	Positive	02 Jun 2022
NCT03689712 (ROMAN, ASCO2022) Manual	Phase 3	Stomatitis \| Head and Neck Neoplasms	407	Intensity-modulated radiotherapy+Cisplatin+placebo	bbojcehqjo(kfljzgawhv) = liywjqtkfe mysrglqlmy (lwvyrweink ) View more	Positive	02 Jun 2022
NCT04225026 (AESOP, GlobeNewswire) Manual	Phase 2	Esophagitis	39	Avasopasem manganese	rxagyfthak(uzledbmvuq) = 17% (grade 2)；3% (grade 3) fckxdtwkea (ydhfoiiowm ) View more	Positive	02 May 2022
NCT04555096 (CTgov)	Phase 2	COVID-19 \| Critical Illness	16	GC4419 (Active GC4419)	jtmlcavkro = mgnetahvuz kfkhdcvfyh (plpnbwakhv, hsnfedywgp - viyhbukmte) View more	-	18 Mar 2022
NCT04555096 (CTgov)	Phase 2	COVID-19 \| Critical Illness	16	Placebo (Placebo)	jtmlcavkro = ylhuqzspyn kfkhdcvfyh (plpnbwakhv, jhplnaztkk - rxdvynlaxe) View more	-	18 Mar 2022

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