Financial Performance - The company reported a net loss of $1,388,000 for the three months ended September 30, 2025, compared to a net loss of $5,581,000 for the same period in 2024, indicating a 75.2% improvement[16]. - The company incurred a net loss of $14.0 million for the nine months ended September 30, 2025, compared to a net loss of $4.1 million for the same period in 2024[39]. - The company reported a net loss of $19.0 million for the year ended December 31, 2024, compared to a net loss of $59.1 million for 2023[96]. - The company reported a net loss of $4.1 million for the three months ended September 30, 2025, compared to a net loss of $5.6 million for the same period in 2024, reflecting a decrease of $1.5 million[115]. Assets and Liabilities - As of September 30, 2025, total assets decreased to $5,002,000 from $10,101,000 as of December 31, 2024, representing a 50.5% decline[13]. - Total liabilities as of September 30, 2025, were $151,647,000, slightly down from $153,770,000 as of December 31, 2024, a decrease of 1.4%[13]. - The accumulated deficit increased to $460,418,000 as of September 30, 2025, from $456,363,000 as of December 31, 2024, an increase of 0.8%[13]. - The company has an accumulated deficit of $460.4 million and expects existing cash and proceeds from asset sales to fund operations for at least twelve months[27]. Cash Flow and Financing - Cash and cash equivalents at the end of the period were $4,473,000, down from $8,289,000 at the beginning of the period, reflecting a decrease of 46.0%[21]. - The company reported cash used in operating activities of $4,451,000 for the nine months ended September 30, 2025, compared to $9,806,000 for the same period in 2024, a reduction of 54.5%[21]. - The company expects existing cash and cash equivalents will fund operations for at least twelve months from the filing date of the Quarterly Report[134]. - The company anticipates needing to raise substantial additional financing to fund operations through equity or debt financings[138]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $130,000, down from $305,000 in the same period of 2024, a decrease of 57.4%[16]. - Research and development expenses for the three months ended September 30, 2025, totaled $130,000, while general and administrative expenses were $1.3 million, leading to a net loss of $1.4 million for the quarter[39]. - Research and development expenses decreased by $2.9 million from $3.2 million for the nine months ended September 30, 2024, to $0.3 million for the nine months ended September 30, 2025[118]. - The company is conducting a Phase 1/2 trial of its pan-NOS inhibitor in combination with nab-paclitaxel and alpelisib for MpBC, with promising initial clinical data reported[26]. Acquisitions and Strategic Focus - The company completed the acquisition of Nova Pharmaceuticals, Inc. on December 30, 2024, issuing 119,318 shares of Series B Non-Voting Convertible Preferred Stock[24]. - Following the acquisition of Nova Pharmaceuticals, the company shifted its strategic focus to developing treatments for advanced breast cancer, including metaplastic breast cancer and triple-negative breast cancer[93]. Stock and Equity - The weighted-average shares of common stock outstanding increased to 98,503,430 for the nine months ended September 30, 2025, compared to 54,392,170 for the same period in 2024, an increase of 81.1%[16]. - The total number of stock options outstanding as of September 30, 2025, was 10,969,734, compared to 5,345,910 in 2024[50]. - The outstanding stock options increased to 10,969,734 shares as of September 30, 2025, with a weighted average exercise price of $1.27 per share[79]. - As of September 30, 2025, there were 2,498,979 shares available for future issuance under the 2019 Incentive Award Plan[75]. Legal and Compliance - The company is not currently involved in any legal proceedings that are likely to materially affect its business or financial results[157]. - No changes in internal control over financial reporting were identified during the quarter ended September 30, 2025, that materially affected internal control[155]. - Management evaluated the effectiveness of disclosure controls and procedures, concluding they were effective at the reasonable assurance level as of September 30, 2025[154]. Miscellaneous - The company completed a private placement on December 30, 2024, issuing 21,070,220 shares and pre-funded warrants for 23,041,040 shares at an offering price of $0.065 per share, generating net proceeds of approximately $2.9 million after costs[25][28]. - The company received an upfront payment of $3.5 million from Biossil for the sale of its assets related to avasopasem and rucosopasem, with potential additional payments of up to $105.0 million based on future milestones[89]. - The company has no ongoing material financing commitments expected to affect liquidity over the next five years[128].

Core Insights - Galera Therapeutics has entered into an Asset Purchase Agreement with Biossil for its dismutase mimetics portfolio, which includes avasopasem and rucosopasem formulations and indications [1][3] - The agreement entails an upfront payment of $3.5 million, with potential future regulatory and commercial milestones, and contingent value rights totaling up to $105 million [1][3] - Biossil will assume all obligations under the Royalty Agreement with Blackstone Life Sciences, which includes a 4% royalty if avasopasem or rucosopasem reaches commercialization [2][3] Company Developments - Galera's lead program is a pan-inhibitor of Nitric Oxide Synthase (NOS), currently in a multicenter Phase 2 trial for metaplastic breast cancer, in combination with alpelisib and nab-paclitaxel [2][4] - Avasopasem has shown promising results in a Phase 3 trial, demonstrating a 16% relative reduction in severe oral mucositis incidence and a 56% relative reduction in duration among patients receiving chemoradiotherapy for head and neck cancer [5] - The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for reducing radiotherapy-induced oral mucositis [6] Strategic Implications - The agreement with Biossil is expected to enhance the prospects for avasopasem's development and commercialization, benefiting both companies and their shareholders [7] - Biossil aims to leverage its expertise and financing to advance avasopasem through clinical and regulatory challenges, addressing the urgent need for treatments that improve the tolerability of chemoradiotherapy [7][10]

[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)

Financial Performance - Net loss for the three months ended March 31, 2025, was $1,592,000, compared to a net loss of $4,381,000 for the same period in 2024, representing a 63.7% improvement[17] - The net loss per share of common stock improved from $(0.08) in Q1 2024 to $(0.01) in Q1 2025, indicating a positive trend in financial performance[17] - The company has incurred an accumulated deficit of $458.0 million as of March 31, 2025, and anticipates further losses until significant sales can be generated from product candidates[32] - The company reported a net loss of $1.592 million for the three months ended March 31, 2025, compared to a net loss of $4.381 million for the same period in 2024, reflecting a 63.7% improvement[42] - Net loss improved by $2.8 million, from a loss of $4.4 million in Q1 2024 to a loss of $1.6 million in Q1 2025[145] Cash and Liquidity - As of March 31, 2025, the company had cash and cash equivalents of $6,686,000, down from $8,289,000 at the beginning of the period, reflecting a decrease of 19.4%[22] - The company expects its existing cash and cash equivalents will not fund operations for more than one year after the issuance of the financial statements, raising substantial doubt about its ability to continue as a going concern[32] - As of March 31, 2025, Galera had $6.7 million in cash and cash equivalents and an accumulated deficit of $458.0 million[118] - The company expects existing cash will fund operations into Q1 2026, but there is substantial doubt about its ability to continue as a going concern beyond that[144][149] Research and Development - Research and development expenses significantly decreased from $1,488,000 in Q1 2024 to $93,000 in Q1 2025, a reduction of approximately 93.8%[17] - Total research and development expenses for the three months ended March 31, 2025, were $93,000, a decrease of 93.7% from $1.488 million in the same period of 2024[42] - Research and development expenses decreased by $1.4 million from $1.5 million in Q1 2024 to $0.1 million in Q1 2025, primarily due to halted clinical trials and reduced personnel costs[137] - The company halted clinical trials for rucosopasem following a futility analysis, indicating a strategic shift in its clinical development pipeline[28] - Galera's lead program is now a Phase 1/2 trial of a pan-NOS inhibitor in combination with nab-paclitaxel and alpelisib for metaplastic breast cancer[115] Acquisitions and Strategic Initiatives - The company completed the acquisition of Nova Pharmaceuticals, Inc. on December 30, 2024, issuing 119,318 shares of Series B Non-Voting Convertible Preferred Stock[30] - Galera completed the acquisition of Nova Pharmaceuticals on December 30, 2024, shifting its strategic focus to advanced breast cancer treatments[114] - The company received $2.9 million from a syndicate of investors led by Ikarian Capital to support the acquisition of Nova[114] Expenses and Cost Management - General and administrative expenses for the three months ended March 31, 2025, totaled $1.870 million, down 39.4% from $3.089 million in the same period of 2024[42] - The company reduced its workforce by 22 employees, or approximately 70%, as part of cost-reduction initiatives following the FDA's Complete Response Letter regarding avasopasem[27] - The company recorded a share-based compensation expense of $137,000 for the three months ended March 31, 2025, a decrease of 84.4% compared to $875,000 for the same period in 2024[99] Liabilities and Financial Position - Total current assets decreased from $10,001,000 on December 31, 2024, to $7,560,000 on March 31, 2025, a decline of approximately 24.4%[14] - The total liabilities decreased slightly from $153,770,000 on December 31, 2024, to $152,024,000 on March 31, 2025, a reduction of approximately 1.1%[14] - The balance of warrant liabilities decreased from $1,055,000 at December 31, 2024, to $0 due to a change in fair value of $(294,000) and reclassification to equity of $(761,000)[60] Legal and Compliance - The company is not currently involved in any legal proceedings that are likely to materially affect its business or financial results[175] - The company has not filed a registration statement with the SEC as of the filing date, which could result in penalties up to 5% of the amount received in the private placement, approximately $145,000[82] Accounting and Reporting - The company is assessing the impact of new accounting standards issued by FASB, including ASU 2023-09 and ASU 2024-03, on its consolidated financial statements[52][53] - Management evaluated the effectiveness of disclosure controls and procedures, concluding they were effective at the reasonable assurance level as of March 31, 2025[172] - There were no changes in internal control over financial reporting that materially affected the company during the quarter ended March 31, 2025[173] Risk Factors - Investing in the company's common stock involves a high degree of risk, with no material changes to previously described risk factors[176]

FDA Designations and Clinical Trials - The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for reducing severe oral mucositis (SOM) induced by radiotherapy [18]. - Avasopasem demonstrated a statistically significant 16% relative reduction in the incidence of SOM (p=0.045) and a 56% relative reduction in the number of days of SOM (median of 18 days in placebo arm vs. 8 days in avasopasem arm) in the Phase 3 ROMAN trial [36]. - The ROMAN trial included 455 patients, with a primary endpoint focused on the reduction of SOM incidence during radiotherapy [33]. - The GT-201 trial showed a 92% reduction in median duration of SOM in the 90 mg treatment arm compared to placebo [44]. - Avasopasem demonstrated a 54.5% incidence of severe oral mucositis (SOM) with a median duration of 9 days in the EUSOM trial, consistent with the ROMAN trial results [52]. - In the Phase 1b/2a trial, 29% of patients receiving 6-7 weeks of avasopasem experienced SOM, with a median duration of 2.5 days, and no patients had Grade 4 oral mucositis [54]. - In the AESOP trial, avasopasem reduced the incidence of severe esophagitis in lung cancer patients receiving chemoradiotherapy, with 35 patients completing treatment [57]. - The one-year follow-up for tumor outcomes in the Phase 1b/2a trial showed a local recurrence control (LRC) rate of 93% and overall survival (OS) rate of 93% among evaluable patients [55]. - The GRECO-1 trial reported that 46% of patients in the active arm were alive at last follow-up compared to 33% in the placebo arm, with 29% achieving a partial response [60]. - The GRECO-2 trial was halted in October 2023 due to a futility analysis indicating it was unlikely to succeed as designed [68]. Financial Performance and Projections - The company reported net losses of $59.1 million for the year ended December 31, 2023, and $19.0 million for the year ended December 31, 2024, with an accumulated deficit of $456.4 million as of December 31, 2024 [183]. - The company has incurred significant operating losses since its inception in 2012, primarily due to research and development expenses and ongoing operations [183]. - None of the company's clinical products have been approved for commercialization, which has contributed to the ongoing financial losses [183]. - The company anticipates continued losses for the foreseeable future as it invests in identifying, acquiring, and developing product candidates [183]. - The company has incurred recurring losses and negative cash flows since inception, with existing cash expected to fund operations only into Q1 2026, raising substantial doubt about its ability to continue as a going concern beyond this period [185]. - Legislative changes, such as the Inflation Reduction Act, may impose inflation rebates on drug manufacturers, affecting pricing and revenue potential [169]. Regulatory and Compliance Challenges - The FDA imposes substantial regulatory requirements on the company for drug development, including compliance with the FDCA [93][95]. - The company must complete preclinical studies and submit an IND to the FDA before initiating human clinical trials [96][99]. - Clinical trials are conducted in three phases, with the FDA and IRB overseeing compliance and safety throughout the process [106][108]. - The FDA conducts a preliminary review of an NDA within 60 days and informs the sponsor by the 74th day whether the application is sufficiently complete for substantive review [115]. - The goal for review of most standard applications is within 10 months from the date of filing, while for "priority review" products, the goal is within 6 months [123]. - The FDA may require an applicant to develop a Risk Evaluation and Mitigation Strategies (REMS) as a condition of approval, which can materially affect the potential market and profitability of a product [118]. - The FDA may issue a complete response letter outlining deficiencies in the submission, which may require substantial additional testing or information [125]. - Drugs manufactured under FDA approvals are subject to ongoing regulation, including periodic reporting and compliance with cGMP requirements [127]. - The FDA may withdraw approval if compliance with regulatory requirements is not maintained or if new problems are discovered post-market [129]. - The FDA strictly regulates marketing and promotion of products, allowing promotion only for approved indications [131]. Intellectual Property and Patent Issues - The company holds approximately 21 issued U.S. patents and 94 issued foreign patents related to its product candidates as of December 31, 2024 [77]. - Avasopasem's U.S. patent covering the method of treating oral mucositis has a natural expiration date in late 2027, with a potential patent term extension of up to five years [81]. - Rucosopasem is covered by a U.S. composition of matter patent with a natural expiration date in 2036, also eligible for a potential five-year extension [81]. - The company has a patent life limitation of 14 years from the product's approval date, affecting potential marketing time [83]. - The company has a limited operating history and is highly dependent on key executives, with potential risks related to employee retention and morale following the Workforce Reduction [203]. - The company acknowledges the risk of potential infringement claims from third parties, which could hinder its operations [211]. - The company may not be able to secure patent protection in all jurisdictions, potentially allowing competitors to use its technologies in unprotected areas [213]. - There is uncertainty regarding the issuance, scope, validity, and enforceability of the company's patent rights, which may affect its competitive advantage [215]. - The company faces challenges in protecting its intellectual property rights in foreign jurisdictions, where laws may not be as favorable as in the United States [215]. - The process of obtaining patent protection is expensive and time-consuming, which may limit the company's ability to prosecute necessary patent applications [212]. Workforce and Operational Changes - The company completed the acquisition of Nova Pharmaceuticals for $2.885 million, shifting focus to developing therapies for advanced breast cancer, including metaplastic breast cancer (MpBC) [21]. - The company anticipates its cash balance will fund operations into 2026, with a reduced headcount of 3 employees as of December 31, 2024 [25]. - A $2.3 million charge was incurred in Q3 2023 due to a Workforce Reduction aimed at reducing operating expenses, which included severance payments and related costs [207]. - The Workforce Reduction may lead to unintended consequences such as loss of institutional knowledge, decreased employee morale, and challenges in redistributing duties among remaining staff [208]. - As of March 28, 2025, the company had 3 employees, with no collective bargaining agreements in place [176]. Market and Commercialization Risks - Coverage and reimbursement from third-party payors are critical for the commercialization of product candidates, with potential delays in obtaining coverage [156]. - The process for obtaining adequate reimbursement is time-consuming and costly, requiring scientific and clinical support for each third-party payor [158]. - State and federal healthcare reforms may limit payments for healthcare products, potentially reducing demand for pharmaceutical products [160]. - The U.S. healthcare reform initiatives may lead to more rigorous coverage criteria and lower reimbursement rates, putting additional pressure on product pricing [172]. - The company must succeed in developing and commercializing product candidates to generate significant revenue and achieve profitability [184]. - The company is heavily dependent on the success of its product candidates, none of which have received regulatory approval, and clinical testing is expensive and time-consuming [189]. - The company relies on third parties for clinical trials, and any failure in their performance could materially affect business prospects [190]. - The company may face dilution of stockholder equity if additional capital is raised through securities offerings or debt financings [186].

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

Financial Performance - The company reported a net loss of $4.4 million for the three months ended March 31, 2024, compared to a net loss of $17.7 million for the same period in 2023, indicating a 75% improvement in losses year-over-year [20]. - The net loss for the three months ended March 31, 2024, was $4.4 million, a decrease of $13.3 million from a net loss of $17.7 million in the same period in 2023 [114]. - The company utilized $4.8 million of net cash in operating activities for the three months ended March 31, 2024, compared to $11.7 million in the same period in 2023 [125]. Assets and Cash Position - As of March 31, 2024, total assets decreased to $19.7 million from $26.1 million as of December 31, 2023, representing a decline of approximately 25% [14]. - Cash and cash equivalents at the end of Q1 2024 were $13.5 million, down from $18.3 million at the end of 2023, reflecting a decrease of about 26% [24]. - As of March 31, 2024, cash and cash equivalents amounted to $13.1 million, a decrease from $18.0 million as of December 31, 2023 [53]. - The company expects its existing cash will fund operations into the third quarter of 2025 [32]. - As of March 31, 2024, the company had $13.5 million in cash and cash equivalents and an accumulated deficit of $441.8 million [123]. Research and Development - Research and development expenses significantly decreased to $1.5 million in Q1 2024 from $7.3 million in Q1 2023, a reduction of approximately 80% [17]. - Research and development expenses for the three months ended March 31, 2024, totaled $549,000, significantly down from $2.7 million in the same period of 2023 [56]. - For the three months ended March 31, 2024, research and development expenses decreased by $5.8 million to $1.5 million from $7.3 million in the same period in 2023 [115]. - The company has ceased all clinical trial activity and suspended the clinical development of its product candidates [102]. - The FDA issued a Complete Response Letter for avasopasem, requiring an additional Phase 3 trial for NDA resubmission, which is currently not feasible for the company [90]. Strategic Alternatives and Workforce - The company is currently exploring strategic alternatives, including potential mergers or asset divestitures, to maximize shareholder value [31]. - A workforce reduction of approximately 70% was implemented in August 2023, resulting in the layoff of 22 employees [29]. - The company is exploring strategic alternatives, including potential mergers or acquisitions, to secure future funding [129]. - The company anticipates that failure to identify strategic alternatives may lead to consideration of dissolution and liquidation [93]. Compliance and Legal Matters - The company received notices from Nasdaq regarding non-compliance with the minimum Market Value of Listed Securities of $50 million and the minimum bid price requirement of $1.00 per share [94]. - The company did not regain compliance with Nasdaq requirements by the specified deadlines and is appealing the delisting decisions [96]. - A lawsuit was filed against Alira Health Clinical, LLC and IQVIA Biotech, LLC for damages related to a breach of contract and negligence in the Phase 3 ROMAN trial [148]. Expenses and Liabilities - General and administrative expenses decreased by $3.5 million to $3.1 million for the three months ended March 31, 2024, compared to $6.6 million in 2023 [116]. - The company incurred total restructuring-related charges of $2.3 million during the year ended December 31, 2023, with $100,000 remaining unpaid as of March 31, 2024 [45]. - The company incurred a restructuring charge of $2.3 million in Q3 2023 due to a workforce reduction of approximately 70% [84]. - The company has recorded a valuation allowance on substantially all deferred tax assets due to uncertainty over the ability to utilize net operating losses and credits [112]. Royalty Agreement - The Royalty Agreement with Blackstone Life Sciences allows for up to $80.0 million in payments upon achieving specified clinical milestones [133]. - The Royalty Purchase Price was increased by $37.5 million to a total of $117.5 million, with a new $20.0 million tranche received in June 2021 upon achieving a clinical enrollment milestone [135]. - The company agreed to sell a high single-digit percentage of worldwide net sales of the Products to Blackstone during the Royalty Period, which lasts until the 12th anniversary of the product's commercial launch or the expiration of patent protections [136]. - The amended Royalty Agreement will remain effective until the total Product Payments exceed a fixed single-digit multiple of the Royalty Purchase Price received [137]. - Two warrants were issued to the Blackstone Purchaser for 550,661 shares at an exercise price of $13.62 per share, exercisable upon receipt of specified milestone payments [138]. Accounting and Reporting - The company is assessing the impact of new accounting standards issued by FASB, effective for future reporting periods [48][51]. - The company opted out of the extended transition period under the JOBS Act, committing to comply with new accounting standards as required for non-emerging growth companies [139]. - The company remains classified as an emerging growth company until total annual gross revenues exceed $1.235 billion or other specified conditions are met [140]. - No changes in internal control over financial reporting were identified that materially affected the company's reporting [144]. Stock Options and Compensation - The company has 5,570,963 stock options outstanding as of March 31, 2024, with a weighted average exercise price of $5.87 [77]. - The company has 1,500,000 shares available for issuance under the 2023 Employment Inducement Award Plan as of March 31, 2024 [76]. - Share-based compensation expense for the three months ended March 31, 2024, was $875,000, a decrease from $1.458 million in the same period of 2023 [77]. - The expected term of employee stock options is 6.2 years, with an expected stock price volatility of 94.9% and a risk-free interest rate of 4.13% [82]. Other Financial Metrics - The company recognized $4.2 million in noncash interest expense during the three months ended March 31, 2023 [61]. - The company suspended recognizing interest expense on the royalty purchase liability after October 2023 due to uncertainty regarding future royalties [65]. - The company completed a registered direct offering in February 2023, resulting in the issuance of 14,320,000 shares and net proceeds of $27.6 million [70]. - The company reported a cash paid for operating leases of $53,000 for the three months ended March 31, 2024, compared to $44,000 in the same period of 2023 [69].

[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)

Regulatory Designations and Trials - Avasopasem has received Fast Track and Breakthrough Therapy designations from the FDA for the reduction of severe oral mucositis (SOM) induced by radiotherapy in head and neck cancer (HNC) patients[18]. - The FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of avasopasem, requiring an additional Phase 3 trial for resubmission, which is currently not feasible with existing resources[19]. - The Phase 2b GRECO-2 trial of rucosopasem in locally advanced pancreatic cancer (LAPC) was halted due to a futility analysis indicating low likelihood of success[21]. - The GRECO-1 trial for rucosopasem was halted in October 2023 following a futility analysis[78]. - The GRECO-2 trial for rucosopasem was also halted in October 2023 due to a futility analysis indicating it was unlikely to succeed as designed[80]. - The AESOP trial demonstrated that avasopasem substantially reduced the incidence of severe esophagitis in lung cancer patients receiving chemoradiotherapy[65]. Financial and Workforce Changes - The company reduced its workforce by 22 employees, approximately 70%, as part of cost-reduction initiatives following the CRL for avasopasem[20]. - A workforce reduction was implemented in August 2023, resulting in a $2.3 million charge primarily for severance payments and related costs[135]. - The ongoing evaluation of strategic alternatives may incur significant costs, including legal and advisory fees, with no assurance of a positive impact on financial results[116]. - The company has incurred net losses of $59.1 million and $62.2 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $437.4 million as of December 31, 2023[117]. Strategic Alternatives and Partnerships - The company engaged Stifel, Nicolaus & Company, Inc. as a financial advisor to explore strategic alternatives, including potential mergers or asset divestitures[22]. - The company is exploring potential strategic alternatives, including mergers, sales, or divestitures, to maximize shareholder value[116]. - The company entered into a Royalty Agreement with Blackstone Life Sciences, which could provide up to $117.5 million upon achieving specified clinical milestones[97][98]. - The company has received a total of $80 million in tranches under the Royalty Agreement, with the latest tranche received in July 2021[99]. - The Royalty Agreement allows Blackstone to receive a high single-digit percentage of worldwide net sales of the products during the Royalty Period[100]. Intellectual Property and Patent Issues - As of December 31, 2023, the company has a patent portfolio consisting of approximately 18 issued U.S. patents, 112 issued foreign patents, and 12 pending U.S. patent applications[89]. - The two most advanced product candidates, avasopasem and rucosopasem, are protected by issued patents with expiration dates in 2027 and 2036, respectively, with potential patent term extensions available[91][92]. - The process of obtaining patent protection is expensive and time-consuming, which may limit the company's ability to secure necessary patents in a timely manner[141]. - The company may not be able to obtain meaningful patent coverage for clinically relevant dosages or infusion rates for its product candidates, avasopasem and rucosopasem, in commercially significant markets[143]. - The issuance of patents is uncertain, and existing or future patents may be challenged, narrowed, or invalidated, limiting the company's ability to prevent competitors from developing similar products[142]. - The company may face significant litigation costs and time commitments in enforcing its intellectual property rights, which could detract from its core business activities[148]. - The company may need to alter its development or commercial strategies if third-party patents are issued that cover its product candidates[152]. - The company could be blocked from commercializing its product candidates if third-party patents are held to cover their manufacturing processes or final products[153]. Compliance and Regulatory Risks - The company's operations are subject to healthcare regulatory laws, which could expose it to penalties and affect business arrangements[186]. - The company faces substantial costs to ensure compliance with healthcare laws and regulations, including the U.S. federal Anti-Kickback Statute and civil false claims laws[187]. - Non-compliance with applicable laws could result in significant penalties, including civil, criminal, and administrative penalties, as well as exclusion from government-funded healthcare programs[188]. Market and Economic Conditions - The global economic conditions have experienced extreme volatility, which could adversely affect the company's financial condition and operations[189]. - The company is currently not in compliance with the minimum Market Value of Listed Securities (MVLS) of $50.0 million required for continued listing on The Nasdaq Global Market[216]. - The bid price for the company's common stock has closed below the required minimum for the last 30 consecutive business days[216]. Cybersecurity and Data Protection - Cybersecurity threats are increasing in frequency and sophistication, posing risks to the company's information technology systems and operations[192]. - The company has been targeted by cybersecurity breach attempts, which could disrupt operations and lead to significant costs if data is lost or compromised[193]. - Compliance with evolving data protection laws, such as GDPR and CCPA, imposes high costs and could result in liabilities for non-compliance[198]. - The company may face fines of up to €20 million or 4% of annual global revenues for non-compliance with GDPR regulations[198]. - The UK GDPR mirrors the GDPR fines, with potential penalties of up to £17.5 million or 4% of global turnover[200]. Environmental and Safety Risks - The company faces potential liabilities under environmental, health, and safety laws, which could result in substantial costs, including fines and penalties[202]. - The company does not maintain insurance for environmental liability or toxic tort claims, exposing it to significant financial risks[204]. - The complexity and frequent changes in environmental laws may lead to increased compliance costs for the company[203]. Employee and Operational Risks - The workforce reduction may lead to unintended consequences, such as loss of institutional knowledge and decreased employee morale[136]. - Misconduct by employees or third parties could lead to significant regulatory penalties and reputational harm for the company[210]. - The company's insurance coverage is becoming increasingly expensive, which may limit its ability to protect against various business risks[206].

[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) |