[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited interim consolidated financial statements and management's discussion and analysis of its financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited interim consolidated financial statements, including balance sheets, statements of operations, changes in stockholders' deficit, and cash flows, along with detailed notes explaining the company's organization, accounting policies, recent acquisition, fair value measurements, and equity structure [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' deficit at specific points in time Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | Change (%) | | :-------------------------------- | :------------ | :---------------- | :----- | :--------- | | Cash and cash equivalents | $5,230 | $8,289 | $(3,059) | -36.9% | | Total current assets | $5,947 | $10,001 | $(4,054) | -40.5% | | Total assets | $6,048 | $10,101 | $(4,053) | -40.1% | | Total current liabilities | $347 | $1,666 | $(1,319) | -79.2% | | Total liabilities | $151,396 | $153,770 | $(2,374) | -1.5% | | Total stockholders' deficit | $(147,945) | $(148,041) | $96 | -0.1% | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) This section presents the company's financial performance over specific periods, detailing revenues, expenses, and net loss Consolidated Statements of Operations Highlights (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | Change (%) | | :------------------------------------------ | :--------------------------- | :--------------------------- | :----- | :--------- | :--------------------------- | :--------------------------- | :----- | :--------- | | Research and development | $84 | $1,430 | $(1,346) | -94.1% | $177 | $2,918 | $(2,741) | -93.9% | | General and administrative | $1,051 | $2,779 | $(1,728) | -62.2% | $2,921 | $5,868 | $(2,947) | -50.2% | | Loss from operations | $(1,135) | $(4,209) | $3,074 | -73.0% | $(3,098) | $(8,786) | $5,688 | -64.7% | | Net loss | $(1,075) | $(4,064) | $2,989 | -73.5% | $(2,667) | $(8,445) | $5,778 | -68.4% | | Net loss per share (basic and diluted) | $(0.00) | $(0.07) | $0.07 | -100.0% | $(0.01) | $(0.16) | $0.15 | -93.8% | [Consolidated Statements of Changes in Stockholders' Deficit](index=7&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Deficit) This section outlines the changes in the company's equity over time, including preferred stock, common stock, additional paid-in capital, and accumulated deficit Changes in Stockholders' Deficit Highlights (in thousands) | Item | January 1, 2025 | March 31, 2025 | June 30, 2025 | | :------------------------------------------ | :-------------- | :------------- | :------------ | | Redeemable convertible preferred stock | $4,372 | $2,864 | $2,597 | | Common stock | $75 | $75 | $75 | | Additional paid-in capital | $308,247 | $310,653 | $311,010 | | Accumulated deficit | $(456,363) | $(457,955) | $(459,030) | | Total Stockholders' Deficit | $(148,041) | $(147,227) | $(147,945) | - Share-based compensation expense: **$227 thousand** (total for 6 months)[19](index=19&type=chunk) - Accretion of redeemable convertible preferred stock to redemption value: **$(1,775) thousand** (total for 6 months)[19](index=19&type=chunk) - Reclassification of pre-funded stock warrants: **$761 thousand**[19](index=19&type=chunk) - Net loss: **$(2,667) thousand** (total for 6 months)[19](index=19&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section details the cash inflows and outflows from operating, investing, and financing activities over specific periods Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :----- | | Net cash used in operating activities | $(3,694) | $(7,508) | $3,814 | | Net cash provided by financing activities | $635 | $0 | $635 | | Net decrease in cash and cash equivalents | $(3,059) | $(7,508) | $4,449 | | Cash and cash equivalents at end of period | $5,230 | $10,749 | $(5,519) | [Notes to Unaudited Interim Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the interim consolidated financial statements, covering accounting policies, acquisitions, and equity [Note 1. Organization and description of business](index=9&type=section&id=Note%201.%20Organization%20and%20description%20of%20business) This note describes the company's biopharmaceutical focus, strategic shift post-FDA setback, acquisition of Nova Pharmaceuticals, and ongoing going concern challenges - Galera Therapeutics, Inc. is a biopharmaceutical company focused on developing small molecule dismutase (SOD) mimetics to improve radiotherapy in cancer. Its lead product candidate, avasopasem, received Fast Track and Breakthrough Therapy designations for reducing severe oral mucositis (SOM) induced by radiotherapy[24](index=24&type=chunk) - In August 2023, the FDA issued a Complete Response Letter (CRL) for avasopasem's NDA, requiring an additional Phase 3 trial, which the company deemed infeasible with current resources. This led to winding down commercial readiness, a **70% workforce reduction**, and exploration of strategic alternatives[25](index=25&type=chunk)[26](index=26&type=chunk) - After stockholders rejected a liquidation plan, Galera acquired Nova Pharmaceuticals, Inc. in December 2024, shifting its strategic focus to developing a pan-inhibitor of nitric oxide synthase for highly resistant breast cancers (MpBC and TNBC). The company's clinical portfolio now includes this pan-NOS inhibitor and two SOD mimetics[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) - The company has incurred recurring losses and negative cash flows, with an accumulated deficit of **$459.0 million** as of June 30, 2025. Management concluded that substantial doubt exists about the company's ability to continue as a going concern beyond the first quarter of 2026, necessitating additional capital or expense deferrals[31](index=31&type=chunk) [Note 2. Basis of presentation and significant accounting policies](index=11&type=section&id=Note%202.%20Basis%20of%20presentation%20and%20significant%20accounting%20policies) This note details the accounting principles used in preparing the financial statements, including U.S. GAAP conformity, segment reporting, and treatment of warrants and R&D costs - The interim consolidated financial statements are prepared in conformity with U.S. GAAP and include all normal and recurring adjustments. They do not include adjustments for liquidation basis accounting, despite the going concern doubt[34](index=34&type=chunk)[35](index=35&type=chunk) - The company's CEO manages business activities as a single operating and reportable segment, using consolidated income/loss from operations and net income/loss to assess performance and allocate resources[39](index=39&type=chunk) - Pre-funded warrants issued in December 2024 were initially classified as liabilities due to redemption terms outside the company's control but were reclassified to equity in March 2025 after an amendment[42](index=42&type=chunk) - Research and development costs are expensed as incurred, based on estimates of work completed by third parties. Net loss per share calculations treat Series B preferred stock as a second class of common stock due to similar characteristics and pro rata loss allocation[44](index=44&type=chunk)[46](index=46&type=chunk) [Note 3. Asset acquisition](index=16&type=section&id=Note%203.%20Asset%20acquisition) This note describes the acquisition of Nova Pharmaceuticals, Inc. in December 2024, including the consideration issued and conversion terms of Series B preferred stock - On December 30, 2024, Galera acquired Nova Pharmaceuticals, Inc., issuing **119,318 shares of Series B preferred stock** with an aggregate fair value of **$2.6 million** as upfront consideration. Stockholder approval is required for the conversion of Series B into common stock, to be sought 12-18 months post-closing[53](index=53&type=chunk)[54](index=54&type=chunk) [Note 4. Fair value measurements](index=16&type=section&id=Note%204.%20Fair%20value%20measurements) This note provides details on the fair value of financial instruments, including money market funds and warrant liabilities, and changes in their valuation Fair Value Measurements (in thousands) | Asset/Liability | June 30, 2025 (Level 1) | December 31, 2024 (Level 1) | December 31, 2024 (Level 2) | | :------------------------------------ | :---------------------- | :------------------------ | :------------------------ | | Money market funds | $5,131 | $6,115 | — | | Warrant liability | — | — | $1,055 | Change in Fair Value of Warrant Liability (6 months ended June 30, 2025, in thousands) | Item | Amount | | :--------------------------- | :----- | | Balance at December 31, 2024 | $1,055 | | Change in fair value | $(294) | | Reclassification to equity | $(761) | | Balance at June 30, 2025 | $0 | [Note 5. Prepaid expenses and other current assets](index=18&type=section&id=Note%205.%20Prepaid%20expenses%20and%20other%20current%20assets) This note details the composition of prepaid expenses and other current assets, including prepaid insurance and other miscellaneous prepayments Prepaid Expenses and Other Current Assets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid insurance | $392 | $795 | | Other prepaid expenses and other current assets | $325 | $282 | | Total | $717 | $1,077 | [Note 6. Property and equipment](index=18&type=section&id=Note%206.%20Property%20and%20equipment) This note explains the write-off of fixed assets and the impact on depreciation and amortization expenses due to office lease termination - The company wrote off its remaining fixed assets in Q3 2024 due to office lease termination. Depreciation and amortization expense was **$15,000** for the six months ended June 30, 2024, but **zero** for the same period in 2025[60](index=60&type=chunk) [Note 7. Accrued expenses](index=19&type=section&id=Note%207.%20Accrued%20expenses) This note provides a breakdown of accrued expenses, including compensation, research and development, and professional fees Accrued Expenses (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Compensation and related benefits | $14 | $48 | | Research and development expenses | $32 | $31 | | Professional fees and other expenses | $99 | $312 | | Total | $145 | $391 | [Note 8. Royalty purchase liability](index=19&type=section&id=Note%208.%20Royalty%20purchase%20liability) This note details the Royalty Agreement with Blackstone Life Sciences, its accounting as a debt instrument, and the suspension of interest expense recognition - Galera has a Royalty Agreement with Blackstone Life Sciences, under which it received **$117.5 million** in proceeds. This is accounted for as a debt instrument, with interest imputed based on estimated royalty repayment[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) - Interest expense recognition on the royalty purchase liability was suspended after October 2023 due to uncertainty of future royalties following the discontinuation of rucosopasem trials and the infeasibility of a new avasopasem Phase 3 trial. No interest expense was recognized in the first six months of 2025 or 2024[65](index=65&type=chunk)[68](index=68&type=chunk) - The agreement grants Blackstone a **high single-digit percentage** of worldwide net sales of avasopasem and rucosopasem (the Products) during the Royalty Period. If no Products are commercialized, the company has no obligation to make Product Payments[66](index=66&type=chunk)[67](index=67&type=chunk) [Note 9. Leases](index=20&type=section&id=Note%209.%20Leases) This note describes the termination of a previous office lease and the commencement of a new operating lease, along with associated rental expenses - The company terminated its previous office lease in August 2024 for a **$0.4 million** fee and entered into a new 12-month operating lease in Malvern, Pennsylvania, commencing February 1, 2025[69](index=69&type=chunk)[70](index=70&type=chunk) Operating Lease Costs (in thousands) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Operating lease rental expense | $4 | $54 | $7 | $108 | | Operating cash flows for operating leases | N/A | N/A | $7 | $88 | [Note 10. Commitments and contingencies](index=21&type=section&id=Note%2010.%20Commitments%20and%20contingencies) This note outlines Nova's exclusive license agreement with Houston Methodist, including due diligence requirements, milestone payments, and royalty obligations - Nova, a Galera subsidiary, holds an exclusive worldwide license with Houston Methodist for oncology patents. The license includes due diligence requirements for IND submission by **January 31, 2028**, and subsequent clinical trials and BLA filing by specified dates[71](index=71&type=chunk)[72](index=72&type=chunk) - Fees are payable upon commercial milestones and **low-to-mid single-digit royalties** on net sales if FDA approval is received. An assignment fee of **$200,000** is payable if the license is assigned before the first Phase III trial[72](index=72&type=chunk)[74](index=74&type=chunk) [Note 11. Equity](index=21&type=section&id=Note%2011.%20Equity) This note details changes in the company's equity structure, including the termination of the Stockholder Rights Agreement, private placement, Series B Preferred Stock issuance, and share-based compensation - The Stockholder Rights Agreement, which declared a dividend of one preferred share purchase right for each common stock share, terminated upon the closing of the Nova acquisition[75](index=75&type=chunk) - In December 2024, a private placement generated **$2.9 million net proceeds** from issuing common stock and pre-funded warrants. The pre-funded warrants were initially liability-classified but reclassified to equity in March 2025 after an amendment[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - **119,318.285 shares of Series B Preferred Stock** were issued to Nova securityholders, convertible into **1,000 common shares each**, subject to stockholder approval 12-18 months post-issuance. If not approved within 24 months, holders can elect cash redemption at fair value[80](index=80&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk)[87](index=87&type=chunk) - Share-based compensation expense for the six months ended June 30, 2025, was **$227,000**, a significant decrease from **$1,598,000** in the prior year, primarily due to reduced R&D and G&A personnel[96](index=96&type=chunk) Stock Option Activity (6 months ended June 30, 2025) | Item | Shares | Weighted-average exercise price per share | | :-------------------------------- | :------- | :-------------------------------------- | | Outstanding at January 1, 2025 | 4,384,108 | $6.01 | | Granted | 8,488,000 | $0.02 | | Forfeited/Expired | (1,756,041) | $6.57 | | Outstanding at June 30, 2025 | 11,116,067 | $1.35 | | Vested and exercisable at June 30, 2025 | 2,562,871 | $5.58 | [Note 12. Related party transactions](index=28&type=section&id=Note%2012.%20Related%20party%20transactions) This note discloses transactions with related parties, including fees paid to IntellectMap Advisory Services and equity issued to board members post-Nova acquisition - Fees incurred with IntellectMap Advisory Services, whose CEO is the brother of Galera's CEO, were **$73,000** for the six months ended June 30, 2025, down from **$92,000** in 2024[103](index=103&type=chunk) - In connection with the Nova acquisition, Dr. Chang and Mr. Friedman (now board members) received Series B shares convertible into **1,841,920** and **8,326,269 common shares**, respectively. Mr. Friedman also entered an Independent Contractor Agreement for corporate and business development services, incurring **$60,000** in fees[104](index=104&type=chunk)[105](index=105&type=chunk) [Note 13. Subsequent events](index=28&type=section&id=Note%2013.%20Subsequent%20events) This note addresses the assessment of new budget and tax legislation signed in July 2025 and its expected impact on the financial statements - New budget and tax legislation signed on **July 4, 2025**, is being assessed for its effect on consolidated financial statements. However, due to a full valuation allowance against U.S. federal deferred tax assets, no material impact is currently expected[106](index=106&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, emphasizing the strategic shift post-Nova acquisition, ongoing liquidity challenges, and the need for future financing [Overview](index=29&type=section&id=Overview) This overview summarizes Galera's strategic pivot from SOD mimetics to a pan-NOS inhibitor for advanced breast cancers following FDA setbacks and the Nova acquisition, highlighting ongoing going concern issues - Galera Therapeutics, a biopharmaceutical company, initially focused on SOD mimetics to reduce radiotherapy side effects. Its lead candidate, avasopasem, received Fast Track and Breakthrough Therapy designations for severe oral mucositis (SOM)[108](index=108&type=chunk) - In August 2023, the FDA issued a Complete Response Letter for avasopasem, requiring a second Phase 3 trial, which was not feasible. This led to winding down avasopasem commercial efforts, significant headcount reduction, and halting rucosopasem clinical trials[109](index=109&type=chunk) - Following stockholder rejection of a liquidation plan, Galera acquired Nova Pharmaceuticals in December 2024, shifting its strategic focus to developing a pan-inhibitor of nitric oxide synthase for advanced breast cancers (MpBC and TNBC)[110](index=110&type=chunk)[111](index=111&type=chunk) - The current lead program is an investigator-sponsored Phase 1/2 trial of the pan-NOS inhibitor for MpBC, funded by an NIH grant. A second trial for TNBC is planned, and an investigator-sponsored trial for avasopasem in HR+ breast cancer is expected to commence in **H2 2025**[112](index=112&type=chunk) - The company has an accumulated deficit of **$459.0 million** as of June 30, 2025, and **$5.2 million** in cash and cash equivalents, expected to fund operations only through **Q1 2026**, raising substantial doubt about its ability to continue as a going concern[115](index=115&type=chunk)[116](index=116&type=chunk) [Critical Accounting Policies and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms the consistency of critical accounting policies and estimates with the prior year's Form 10-K, noting no material changes - The company's critical accounting policies and estimates are consistent with those discussed in the 2024 Form 10-K, with no material changes identified during the six months ended June 30, 2025[119](index=119&type=chunk) [Components of Results of Operations](index=31&type=section&id=Components%20of%20Results%20of%20Operations) This section details the nature of research and development, general and administrative expenses, and the company's tax loss carryforwards and valuation allowance - Research and development expenses are expensed as incurred, primarily covering third-party services for product candidate development, clinical trials, manufacturing, and regulatory compliance. Internal R&D expenses are not tracked program-by-program[120](index=120&type=chunk)[123](index=123&type=chunk) - General and administrative expenses include personnel costs (salaries, benefits, share-based compensation), corporate facility costs, legal fees, and accounting/consulting services. These expenses are expected to increase with continued R&D and operational expansion, assuming additional capital is secured[130](index=130&type=chunk)[131](index=131&type=chunk) - The company had federal and state net operating loss carryforwards of **$209.5 million** and **$231.9 million**, respectively, and federal R&D tax credit carryforwards of **$9.0 million** as of December 31, 2024. A full valuation allowance is recorded against deferred tax assets due to uncertainty of utilization[133](index=133&type=chunk)[134](index=134&type=chunk) [Results of Operations - Comparison of the Three and Six months ended June 30, 2025 and 2024](index=35&type=section&id=Results%20of%20Operations%20-%20Comparison%20of%20the%20Three%20and%20Six%20months%20ended%20June%2030,%202025%20and%202024) This section compares the company's financial performance for the three and six months ended June 30, 2025 and 2024, highlighting significant reductions in R&D and G&A expenses Results of Operations (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | | :------------------------------------------ | :--------------------------- | :--------------------------- | :----- | :--------------------------- | :--------------------------- | :----- | | Research and development | $84 | $1,430 | $(1,346) | $177 | $2,918 | $(2,741) | | General and administrative | $1,051 | $2,779 | $(1,728) | $2,921 | $5,868 | $(2,947) | | Loss from operations | $(1,135) | $(4,209) | $3,074 | $(3,098) | $(8,786) | $5,688 | | Interest income | $60 | $149 | $(89) | $137 | $345 | $(208) | | Change in fair value of warrant liability | $0 | $0 | $0 | $294 | $0 | $294 | | Net loss | $(1,075) | $(4,064) | $2,989 | $(2,667) | $(8,445) | $5,778 | - Research and development expense decreased significantly by **$1.3 million (94.1%)** for the three months and **$2.7 million (93.9%)** for the six months ended June 30, 2025, primarily due to the termination of R&D employees and halting rucosopasem trials[138](index=138&type=chunk)[139](index=139&type=chunk) - General and administrative expense decreased by **$1.7 million (62.2%)** for the three months and **$3.0 million (50.2%)** for the six months ended June 30, 2025, mainly due to reduced headcount, vested stock options, and lower legal/professional fees[140](index=140&type=chunk)[141](index=141&type=chunk) - Interest income decreased due to a reduction in investable cash and securities. A **$0.3 million** change in the fair value of warrant liability was recognized in the six months ended June 30, 2025, prior to reclassification to equity[142](index=142&type=chunk)[143](index=143&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, accumulated deficit, and the substantial doubt about its ability to continue as a going concern without additional financing - As of June 30, 2025, the company had **$5.2 million** in cash and cash equivalents and an accumulated deficit of **$459.0 million**. Existing cash is expected to fund operations only through **Q1 2026**, indicating substantial doubt about its ability to continue as a going concern[148](index=148&type=chunk) - The company has historically funded operations through equity sales and **$117.5 million** from the Royalty Agreement with Blackstone Life Sciences, totaling **$379.9 million** in aggregate gross proceeds[145](index=145&type=chunk) - Future funding requirements are substantial and uncertain, dependent on clinical trial progress, regulatory review, collaborations, intellectual property costs, and manufacturing. The company anticipates needing to raise additional financing through equity, debt, or strategic transactions, which may result in significant dilution or restrictive covenants[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) [Cash Flows](index=39&type=section&id=Cash%20Flows) This section summarizes the company's cash flows from operating and financing activities, noting a decrease in cash used in operations and proceeds from financing Summary of Cash Flows (in thousands) | Activity | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(3,694) | $(7,508) | | Net cash provided by financing activities | $635 | $0 | | Net decrease in cash and cash equivalents | $(3,059) | $(7,508) | - Net cash used in operating activities decreased from **$7.5 million** in H1 2024 to **$3.7 million** in H1 2025, reflecting a reduced net loss and changes in operating assets and liabilities[150](index=150&type=chunk)[151](index=151&type=chunk) - Financing activities provided **$0.6 million** in H1 2025 from the sale of common stock in a December 2024 private placement[152](index=152&type=chunk) [Key Agreements](index=43&type=section&id=Key%20Agreements) This section outlines significant agreements, including the Royalty Agreement with Blackstone Life Sciences, the Master Manufacturing Services Agreement with Patheon, and Nova's License Agreement with Houston Methodist - The Royalty Agreement with Blackstone Life Sciences provided **$117.5 million** in proceeds, in exchange for a **high single-digit percentage** of worldwide net sales of avasopasem and rucosopasem. The agreement remains in effect until Product Payments exceed a fixed multiple of the purchase price[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk) - Galera has a Master Manufacturing Services Agreement with Patheon for avasopasem manganese, with an initial term expiring **December 31, 2027**. There are no current contractual commitments to purchase avasopasem under this agreement[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - Nova's License Agreement with Houston Methodist grants exclusive rights to oncology patents, with due diligence requirements for IND submission and clinical trials. Fees and **low-to-mid single-digit royalties** are payable upon commercial milestones and net sales[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Galera Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[173](index=173&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management acknowledges the inherent limitations of controls and procedures, providing only reasonable assurance, and concluded that disclosure controls were effective with no material changes in internal control over financial reporting - Management recognizes that controls and procedures provide only reasonable assurance and require judgment in balancing benefits and costs[174](index=174&type=chunk) - As of **June 30, 2025**, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[175](index=175&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended **June 30, 2025**[176](index=176&type=chunk) [PART II. OTHER INFORMATION](index=48&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to materially affect its business or financial results - The company is not currently involved in any legal proceedings deemed likely to materially affect its business or financial results[179](index=179&type=chunk) [Item 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) Investing in the company's common stock involves a high degree of risk, with no material changes to the risk factors previously described in the 2024 Form 10-K - Investing in the company's common stock involves a high degree of risk. No material changes to the risk factors described in the 2024 Form 10-K have occurred[180](index=180&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds to report[181](index=181&type=chunk) [Item 3. Defaults Upon Senior Securities](index=48&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[182](index=182&type=chunk) [Item 4. Mine Safety Disclosures](index=48&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[183](index=183&type=chunk) [Item 5. Other Information](index=48&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025 - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended **June 30, 2025**[184](index=184&type=chunk) [Item 6. Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed or furnished with the report, including corporate governance documents, registration rights agreements, and certifications - The report includes a list of exhibits, such as the Restated Certificate of Incorporation, Certificate of Designation for Series B Preferred Stock, Amended and Restated Bylaws, Stockholder Rights Agreement, and various certifications[187](index=187&type=chunk) [Signatures](index=50&type=section&id=Signatures) The report is duly signed on behalf of Galera Therapeutics, Inc. by its Chief Executive Officer and President, J. Mel Sorensen, M.D., and Chief Accounting Officer, Joel Sussman, as of August 13, 2025 - The report is signed by J. Mel Sorensen, M.D., Chief Executive Officer and President, and Joel Sussman, Chief Accounting Officer, on **August 13, 2025**[193](index=193&type=chunk)

FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39114 Galera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 46-1454898 (State ...

or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39114 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company's financial position significantly weakened by September 30, 2024, marked by substantial decreases in cash and total assets, a reduced net loss due to expense cuts, and negative operating cash flow without 2024 financing activities [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of September 30, 2024, total assets sharply declined to $8.9 million from $26.1 million, primarily due to reduced cash and asset write-offs, while total liabilities decreased slightly and the stockholders' deficit widened Consolidated Balance Sheet Highlights (in thousands) | Metric | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,455 | $18,257 | | Total Assets | $8,901 | $26,141 | | Total Liabilities | $151,963 | $157,326 | | Royalty purchase liability | $151,049 | $151,049 | | Total stockholders' deficit | $(143,062) | $(131,185) | - In August 2024, the company wrote off its IPR&D asset (**$2.3 million**) and related goodwill (**$0.9 million**) in their entirety after the board approved a Plan of Dissolution, concluding the assets were impaired[48](index=48&type=chunk) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For the nine months ended September 30, 2024, the company significantly reduced its net loss to $14.0 million from $53.5 million in 2023, driven by sharp cuts in R&D and G&A expenses, alongside asset write-offs and a litigation settlement gain Operating Results (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Research and development | $3,223 | $20,926 | | General and administrative | $9,307 | $20,849 | | Write-off of intangible asset & goodwill | $3,139 | $0 | | Gain on litigation settlement | $(975) | $0 | | Loss from operations | $(14,694) | $(44,084) | | Net loss | $(14,026) | $(53,495) | | Net loss per share | $(0.26) | $(1.30) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased to $9.8 million for the nine months ended September 30, 2024, with no financing activities, resulting in a $9.8 million reduction in cash and cash equivalents Cash Flow Summary (in thousands) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,806) | $(34,933) | | Net cash provided by investing activities | $4 | $23,318 | | Net cash provided by financing activities | $0 | $31,728 | | Net (decrease) increase in cash | $(9,802) | $20,113 | | Cash and cash equivalents at end of period | $8,455 | $24,429 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Following the cessation of clinical development and unapproved dissolution plan, management is exploring strategic alternatives, with operations scaled back and current cash expected to fund operations for at least twelve months despite Nasdaq delisting - Following the FDA's CRL for avasopasem requiring an additional trial, the company halted development, wound down commercial readiness, and reduced its workforce by approximately **70%** in August 2023[30](index=30&type=chunk)[31](index=31&type=chunk)[95](index=95&type=chunk) - A plan of dissolution and liquidation was not approved by stockholders on October 17, 2024. The company is now exploring other alternatives, including a merger, asset sale, or another dissolution attempt later[34](index=34&type=chunk)[99](index=99&type=chunk)[101](index=101&type=chunk) - The company's common stock was delisted from Nasdaq and began trading on the OTC Pink Market on June 4, 2024, which may negatively impact stock price and liquidity[103](index=103&type=chunk) - As of September 30, 2024, the company had **$8.5 million** in cash and cash equivalents, which is expected to fund operating expenses for at least twelve months[135](index=135&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Operating expenses significantly decreased in the first nine months of 2024 due to reduced R&D and G&A following clinical trial cessation, alongside non-cash impairment charges and a litigation settlement gain Comparison of Operating Results (in thousands) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $3,223 | $20,926 | $(17,703) | | General and administrative | $9,307 | $20,849 | $(11,542) | | Write-off of intangible asset & goodwill | $3,139 | $— | $3,139 | | Gain on litigation settlement | $(975) | $— | $(975) | | Restructuring costs | $— | $2,309 | $(2,309) | | Loss from operations | $(14,694) | $(44,084) | $29,390 | [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) The company, historically funded by equity and a royalty agreement, holds $8.5 million in cash as of September 30, 2024, expected to fund operations for twelve months, with no 2024 financing activities and suspended interest accretion on its royalty liability - The company has funded operations through **$377.0 million** in aggregate gross proceeds from equity sales and **$117.5 million** from a Royalty Agreement with Blackstone Life Sciences[132](index=132&type=chunk) - The company suspended accreting interest on its royalty purchase liability in October 2023 due to the unlikelihood of generating future royalties after halting its clinical programs[66](index=66&type=chunk)[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company as defined in Rule 12b-2 of the Exchange Act, the company is not required to provide the information otherwise required under this Item 3[154](index=154&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2024, with no material changes to internal control over financial reporting identified during the quarter - Based on an evaluation as of the end of the reporting period, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[157](index=157&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[158](index=158&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) On August 2, 2024, the company settled a lawsuit against its CROs, receiving $975,000 in exchange for mutual releases and termination of the litigation - The company settled litigation against its CROs for **$975,000** on August 2, 2024, related to an error in the Phase 3 ROMAN trial statistical program[161](index=161&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company highlights substantial risks for investors, including the failure to approve dissolution, stock delisting to the OTC Pink Market impacting liquidity, and a history of significant, ongoing operating losses - The failure of stockholders to approve the Plan of Dissolution means the company must continue to explore other, potentially less valuable, strategic alternatives like a merger, asset sale, or bankruptcy[165](index=165&type=chunk) - The company's common stock is quoted on the OTC Pink Market, which is less regulated than Nasdaq and may result in lower liquidity and a depressed trading price[171](index=171&type=chunk) - The company has a history of significant operating losses (**$59.1 million** in 2023) and an accumulated deficit of **$437.4 million** as of December 31, 2023, with losses expected to continue[167](index=167&type=chunk)[168](index=168&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the reporting period - None[175](index=175&type=chunk) [Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - None[176](index=176&type=chunk) [Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[177](index=177&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) This section discloses material impairments to the company's IPR&D asset and goodwill, resulting in non-cash charges of $2.3 million and $0.9 million respectively, with no Rule 10b5-1 trading plan changes by officers or directors - The company recognized non-cash impairment charges of **$2.3 million** for its IPR&D asset and **$0.9 million** for goodwill during the third quarter of 2024[180](index=180&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or furnished with the quarterly report, including corporate governance documents, a separation agreement, and officer certifications

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39114 Galera Therapeutics, Inc. (I.R.S. Employer Identification No.) (610) 725-1500 (Registrant's telephone numbe ...

[Company Overview & Strategic Updates](index=1&type=section&id=Company%20Overview%20%26%20Strategic%20Updates) Galera Therapeutics is a clinical-stage biopharmaceutical company evaluating strategic alternatives and implementing stockholder protection measures [Introduction and Strategic Review](index=1&type=section&id=Introduction%20and%20Strategic%20Review) Galera Therapeutics, a clinical-stage biopharmaceutical company, is evaluating strategic alternatives including mergers, asset sales, or dissolution to maximize stockholder value - Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to transform radiotherapy in cancer[1](index=1&type=chunk) - The company is actively evaluating potential strategic alternatives, including mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions, which may encompass a development path for avasopasem or culminate in company dissolution[2](index=2&type=chunk) [General Corporate Updates](index=1&type=section&id=General%20Corporate%20Updates) Galera continues its strategic review with Stifel, Nicolaus & Company, Inc. and adopted a stockholder rights agreement to protect stockholder interests - Galera remains actively engaged with Stifel, Nicolaus & Company, Inc. to undertake a comprehensive review of strategic alternatives for the Company and its portfolio, with no fixed timeline for completion[4](index=4&type=chunk) - On May 3, 2024, the Board of Directors adopted a limited duration stockholder rights agreement to protect stockholder interests by reducing the likelihood of control acquisition without an appropriate premium[4](index=4&type=chunk) [About Galera Therapeutics](index=2&type=section&id=About%20Galera%20Therapeutics) Galera Therapeutics historically developed novel therapeutic candidates like avasopasem and rucosopasem to transform radiotherapy in cancer - Galera Therapeutics historically focused on developing novel, proprietary therapeutic candidates with the potential to transform radiotherapy in cancer[5](index=5&type=chunk) - Avasopasem manganese (avasopasem) was being developed for radiation-induced and cisplatin-related toxicities, receiving FDA Fast Track and Breakthrough Therapy designations[5](index=5&type=chunk) - Rucosopasem manganese (rucosopasem) was being developed to augment anti-cancer efficacy in non-small cell lung cancer and locally advanced pancreatic cancer, receiving Orphan Drug designation from the FDA and EMA[5](index=5&type=chunk) [First Quarter 2024 Financial Results](index=1&type=section&id=First%20Quarter%202024%20Financial%20Results) Galera reported significantly reduced operating expenses and net loss in Q1 2024, with cash expected to fund operations into Q3 2025 [Financial Highlights](index=1&type=section&id=First%20Quarter%202024%20Financial%20Highlights) Galera significantly reduced Q1 2024 operating expenses and net loss, with **$13.5 million** cash expected to fund operations into Q3 2025 First Quarter Financial Performance | Metric | Q1 2024 (Millions USD) | Q1 2023 (Millions USD) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | R&D Expenses | $1.5 | $7.3 | -79.5% | | G&A Expenses | $3.1 | $6.6 | -53.0% | | Net Loss | $(4.4) | $(17.7) | -75.1% | | Net Loss Per Share (USD) | $(0.08) | $(0.50) | -84.0% | - The decrease in research and development expenses was primarily attributable to the cessation of all clinical trial activity and suspension of clinical development for product candidates[3](index=3&type=chunk) - The decrease in general and administrative expenses was primarily due to the cessation of avasopasem commercial preparations and medical affairs activities, and reduced personnel-related expenses from an August 2023 workforce reduction[7](index=7&type=chunk) - As of March 31, 2024, Galera had cash and cash equivalents of **$13.5 million**, which are expected to fund operating expenses and capital expenditure requirements into the third quarter of 2025[7](index=7&type=chunk) [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations) Galera's consolidated statements of operations for the three months ended March 31, 2024, reflect a substantial reduction in operating expenses and net loss compared to the prior year, driven by decreased research and development and general and administrative costs Consolidated Statements of Operations Data | Metric (in thousands) | 2024 | 2023 | | :-------------------- | :--- | :--- | | 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) | | Weighted average common shares outstanding, basic and diluted | 54,392,170 | 35,196,134 | [Selected Consolidated Balance Sheet Data](index=3&type=section&id=Selected%20Consolidated%20Balance%20Sheet%20Data) As of March 31, 2024, Galera's selected consolidated balance sheet data shows a decrease in cash and cash equivalents, total assets, and total current liabilities compared to December 31, 2023, while total stockholders' deficit increased Selected Consolidated Balance Sheet Data | Metric (in thousands) | March 31, 2024 | December 31, 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) | [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements subject to significant risks, including funding needs, clinical trial uncertainties, and the potential for operational cessation [Disclaimer and Key Risks](index=3&type=section&id=Disclaimer%20and%20Key%20Risks) Forward-looking statements are subject to significant risks including funding, clinical trials, regulatory approvals, and the potential inability to secure strategic alternatives or additional funding - Forward-looking statements are subject to known and unknown risks, uncertainties, and other important factors that may cause Galera's actual results, performance, or achievements to be materially different[6](index=6&type=chunk) - Key risks include limited operating history, anticipated continued losses, the need for substantial funding, dependence on avasopasem, uncertainties in clinical trials, regulatory approval risks, and the inability to enter into any desired strategic alternative or partnership, which could lead to the cessation of operations[6](index=6&type=chunk)[8](index=8&type=chunk) - Galera's ability to fund its operating expenses and capital expenditure requirements into the third quarter of 2025 is a forward-looking statement[6](index=6&type=chunk) [Investor & Media Contacts](index=4&type=section&id=Investor%20%26%20Media%20Contacts) This section provides essential contact information for investor relations and media inquiries for Galera Therapeutics [Contact Information](index=4&type=section&id=Contact%20Information) This section provides contact details for investor relations and media inquiries for Galera Therapeutics, Inc - Investor contacts are Christopher Degnan from Galera Therapeutics, Inc. and William Windham from Solebury Strategic Communications[12](index=12&type=chunk) - Media contact is Timothy Biba from Solebury Strategic Communications[12](index=12&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39114 Galera Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 46-1454898 (State or other jurisdicti ...

[Corporate Overview and Strategic Direction](index=1&type=section&id=Corporate%20Overview%20and%20Strategic%20Direction) Galera is implementing cost-saving measures and exploring strategic alternatives, including potential dissolution, after FDA feedback and program discontinuations [Strategic Review and Corporate Actions](index=1&type=section&id=Strategic%20Review%20and%20Corporate%20Actions) Galera implemented significant cost-saving measures, including a 70% workforce reduction, and is exploring strategic alternatives - The company is exploring strategic options to maximize shareholder value, including a **potential new development path for avasopasem** or the **dissolution of the company**[2](index=2&type=chunk) - In August 2023, the company reduced its workforce by approximately **70%** to lower operational costs[4](index=4&type=chunk) - Stifel, Nicolaus & Company, Inc. was engaged in October 2023 as a financial advisor to assist in reviewing strategic alternatives[4](index=4&type=chunk) [Clinical Development Updates](index=1&type=section&id=Clinical%20Development%20Updates) Clinical development updates include FDA's requirement for an additional avasopasem trial and the discontinuation of rucosopasem programs [Avasopasem Program Updates](index=1&type=section&id=Avasopasem%20Program%20Updates) FDA issued a CRL for avasopasem NDA, requiring an additional trial for SOM, while ROMAN trial showed 50% CKD reduction - In August 2023, the FDA issued a Complete Response Letter (CRL) for the avasopasem NDA, deeming the Phase 2b and Phase 3 data **insufficient for approval**[4](index=4&type=chunk) - A Type A meeting with the FDA in September 2023 confirmed the need for an **additional Phase 3 trial** to support an NDA resubmission for avasopasem[8](index=8&type=chunk) - Data presented at ASN Kidney Week 2023 showed a **50% reduction** in the incidence of cisplatin-related Chronic Kidney Disease (CKD) at one year in the avasopasem arm compared to placebo[5](index=5&type=chunk) [Rucosopasem Program Updates](index=2&type=section&id=Rucosopasem%20Program%20Updates) Galera discontinued its rucosopasem development programs, halting GRECO-2 due to futility and subsequently GRECO-1 - The Phase 2b GRECO-2 trial of rucosopasem in patients with LAPC was halted in October 2023 following an **unsuccessful futility analysis**[9](index=9&type=chunk) - Following the GRECO-2 futility analysis, the company also decided to **halt the Phase 1/2 GRECO-1 trial** of rucosopasem in patients with NSCLC[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) The company significantly reduced operating expenses and net loss in Q4 2023, with a modest improvement in full-year net loss [Fourth Quarter 2023 Financial Highlights](index=2&type=section&id=Fourth%20Quarter%202023%20Financial%20Highlights) In Q4 2023, Galera significantly reduced operating expenses and net loss, ending the year with **$18.3 million** in cash Q4 2023 vs Q4 2022 Financials (in thousands, except per share data) | Metric | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | | Research & Development Expenses | $3,189 | $8,137 | | General & Administrative Expenses | $1,987 | $5,021 | | Net Loss | $(5,587) | $(16,188) | | Net Loss Per Share | $(0.10) | $(0.58) | - As of December 31, 2023, the company had cash and cash equivalents of **$18.3 million**, which is expected to fund operations into the second quarter of 2025[9](index=9&type=chunk) [Full Year 2023 Financial Highlights](index=3&type=section&id=Full%20Year%202023%20Financial%20Highlights) For FY2023, R&D expenses decreased, G&A rose, and the net loss was **$59.1 million**, including **$2.3 million** in restructuring charges Full Year 2023 vs 2022 Financials (in thousands, except per share data) | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Research & Development Expenses | $24,115 | $31,012 | | General & Administrative Expenses | $22,836 | $20,214 | | Net Loss | $(59,082) | $(62,222) | | Net Loss Per Share | $(1.33) | $(2.30) | - The company incurred restructuring-related charges of **$2.3 million** in Q3 2023, primarily for severance and employee benefits from the workforce reduction[13](index=13&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) This section presents detailed Consolidated Statements of Operations and Balance Sheet Data for 2023 and 2022 Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended Dec 31, | Year Ended Dec 31, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $3,189 | $8,137 | $24,115 | $31,012 | | General and administrative | $1,987 | $5,021 | $22,836 | $20,214 | | Restructuring costs | $— | $— | $2,309 | $— | | **Loss from operations** | **$(5,176)** | **$(13,158)** | **$(49,260)** | **$(51,226)** | | **Net Loss** | **$(5,587)** | **$(16,188)** | **$(59,082)** | **$(62,222)** | | **Net loss per share** | **$(0.10)** | **$(0.58)** | **$(1.33)** | **$(2.30)** | Selected Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $18,257 | $31,597 | | Total assets | $26,141 | $44,036 | | Total liabilities | $157,326 | $153,217 | | Total stockholders' deficit | $(131,185) | $(109,181) |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39114 Galera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 46-1454898 (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) (Exact name of registrant as specified in its charter) Delaware 46-1454898 (State or other jurisdiction of incorporation or organization) 45 Liberty Blvd, Suite 230 Malvern, Pennsylvania 19355 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ ...