[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [ITEM 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Galectin Therapeutics Inc.'s unaudited condensed consolidated financial statements for Q2 2025, detailing balance sheets, operations, cash flows, and stockholders' deficit, with notes on accounting policies and financial instruments [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and an increase in total liabilities from December 31, 2024, to June 30, 2025, primarily driven by changes in convertible notes payable and derivative liabilities, leading to an increased stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :------------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $13,771 | $15,120 | $(1,349) | -8.92% | | Total current assets | $15,427 | $17,252 | $(1,825) | -10.58% | | Total assets | $15,602 | $17,495 | $(1,893) | -10.82% | | Total current liabilities | $10,774 | $35,409 | $(24,635)| -69.57% | | Total liabilities | $132,769 | $120,565 | $12,204 | 10.12% | | Total stockholders' deficit | $(118,890) | $(104,793) | $(14,097)| 13.45% | - Convertible notes payable and accrued interest (non-current) increased significantly from **$10,733,000** at December 31, 2024, to **$32,308,000** at June 30, 2025[7](index=7&type=chunk) - Borrowing and accrued interest under convertible lines of credit (related party) increased from **$74,376,000** to **$88,150,000**[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a reduced net loss for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to a significant decrease in research and development expenses, despite an increase in interest expense and change in fair value of derivative liabilities Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $3,261 | $9,813 | $9,746 | $17,867 | | General and administrative | $1,364 | $1,478 | $2,776 | $3,072 | | Total operating expenses | $4,625 | $11,291 | $12,522 | $20,939 | | Total operating loss | $(4,625) | $(11,291) | $(12,522) | $(20,939) | | Interest expense | $(1,826) | $(1,269) | $(3,570) | $(2,321) | | Change in fair value of derivative | $(1,096) | $109 | $(1,121) | $(760) | | Net loss | $(7,521) | $(12,371) | $(17,152) | $(23,860) | | Net loss per common share | $(0.12) | $(0.20) | $(0.27) | $(0.39) | - Research and development expenses decreased by **67%** for the three months ended June 30, 2025, and by **45%** for the six months ended June 30, 2025, compared to the prior year periods[9](index=9&type=chunk) - Net loss applicable to common stockholders decreased from **$(12,435,000)** to **$(7,584,000)** for the three months ended June 30, 2025, and from **$(23,932,000)** to **$(17,189,000)** for the six months ended June 30, 2025[9](index=9&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to lower net loss and adjustments for non-cash items. However, net cash flows from financing activities also decreased, leading to a larger net decrease in cash and cash equivalents Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(17,152) | $(23,860) | | Net cash from operating activities | $(14,291) | $(20,438) | | Net cash flows from financing activities | $12,942 | $20,376 | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(1,349) | $(62) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $13,771 | $25,598 | - Net cash used in operating activities decreased by **$6,147,000**, from **$(20,438,000)** in 2024 to **$(14,291,000)** in 2025[11](index=11&type=chunk) - Net cash flows from financing activities decreased by **$7,434,000**, from **$20,376,000** in 2024 to **$12,942,000** in 2025, primarily due to decreased borrowings under related party lines of credit[11](index=11&type=chunk)[160](index=160&type=chunk) [Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) The statements detail changes in preferred stock and stockholders' deficit, reflecting net losses, preferred stock dividends, common stock issuances from option/warrant exercises, and conversions, leading to an increased accumulated deficit - Total stockholders' deficit increased from **$(104,793,000)** at December 31, 2024, to **$(118,890,000)** at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Common stock outstanding increased from **63,157,235** shares at December 31, 2024, to **64,060,262** shares at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Additional paid-in capital increased from **$296,217,000** to **$299,318,000**, while retained deficit increased from **$(401,572,000)** to **$(418,761,000)** due to net losses and preferred stock dividends[7](index=7&type=chunk)[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical context to the financial statements, detailing the company's business, liquidity challenges, related-party debt, fair value measurements, stock-based compensation, and clinical development activities, highlighting the going concern uncertainty and reliance on future financing [1. Basis of Presentation and Liquidity](index=10&type=section&id=1.%20Basis%20of%20Presentation%20and%20Liquidity) Galectin Therapeutics Inc. is a clinical-stage biopharmaceutical company facing going concern uncertainty due to historical losses and no revenue, despite having $13.8 million cash and a new $10 million credit line to fund operations through June 2026 - The Company is a clinical stage biopharmaceutical company developing therapies for fibrotic disease and cancer by targeting galectin proteins[17](index=17&type=chunk) - The Company has operated at a loss since its inception and has had no revenues, anticipating continued losses[20](index=20&type=chunk) Liquidity Position (in thousands) | Metric | June 30, 2025 | | :-------------------------------- | :------------ | | Unrestricted cash and cash equivalents | $13,771 | | New line of credit (July 8, 2025) | $10,000 | - The Company believes it has sufficient cash, including the new line of credit, to fund planned operations through **June 30, 2026**, but needs to raise additional capital thereafter[20](index=20&type=chunk) [2. Accrued Expenses and Other](index=10&type=section&id=2.%20Accrued%20Expenses%20and%20Other) Accrued expenses decreased significantly from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued research and development costs and accrued compensation. The company accrues clinical trial expenses based on estimated work completed by CROs Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Legal and accounting fees | $71 | $74 | | Accrued compensation | $844 | $1,523 | | Lease liability | $52 | $19 | | Accrued research and development costs | $3,879 | $6,588 | | Total | $4,846 | $8,204 | - Accrued research and development costs decreased by **$2,709,000**, from **$6,588,000** to **$3,879,000**[22](index=22&type=chunk) - Accrued compensation decreased by **$679,000**, from **$1,523,000** to **$844,000**[22](index=22&type=chunk) [3. Convertible Notes Payable – Related Party](index=12&type=section&id=3.%20Convertible%20Notes%20Payable%20%E2%80%93%20Related%20Party) The company has three convertible promissory notes totaling $30 million from a related party (Richard E. Uihlein), all of which had their maturity dates extended to September 30, 2026. These notes bear 2% annual interest and include a contingent interest component recognized as a derivative liability, which has seen significant fair value changes - Three convertible promissory notes (April 2021, September 2021, December 2021), each for **$10,000,000**, were issued by Richard E. Uihlein[24](index=24&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk) - All three notes' maturity dates were extended to **September 30, 2026**, in connection with the July 2025 Supplemental Line of Credit[27](index=27&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk)[103](index=103&type=chunk) - Contingent interest components of these notes are bifurcated and recognized as derivative liabilities, with fair values increasing significantly from December 31, 2024, to June 30, 2025[26](index=26&type=chunk)[29](index=29&type=chunk)[31](index=31&type=chunk)[34](index=34&type=chunk) [4. Fair Value of Financial Instruments](index=13&type=section&id=4.%20Fair%20Value%20of%20Financial%20Instruments) The company's Level 3 derivative liabilities, primarily contingent interest on convertible notes, increased substantially from December 31, 2024, to June 30, 2025. These are valued using a Monte Carlo Geometric Brownian Stock Path Model, with key assumptions including stock price, term, risk-free rate, credit-adjusted discount rate, and volatility Level 3 Derivative Liabilities (in thousands) | Derivative Liability | June 30, 2025 | December 31, 2024 | | :------------------------------------- | :------------ | :---------------- | | Contingent Interest April Note | $650 | $47 | | Contingent Interest September Note | $298 | $94 | | Contingent Interest December Note | $589 | $275 | | Total | $1,537 | $416 | - The fair value adjustment for the April Note derivative liability was **$603,000** for the six months ended June 30, 2025[35](index=35&type=chunk) - Key valuation assumptions for derivatives include a stock price of **$2.11** at June 30, 2025 (up from **$1.29** at Dec 31, 2024) and volatility ranging from **101%** to **102%**[35](index=35&type=chunk) [5. Stock-Based Compensation](index=16&type=section&id=5.%20Stock-Based%20Compensation) Total stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to 2024. Stock option activity included significant grants and exercises, while restricted stock units were issued to employees with vesting tied to a partnership or year-end Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $254 | $386 | $530 | $709 | | General and administrative | $246 | $352 | $436 | $633 | | Total stock-based compensation expense | $500 | $738 | $966 | $1,342 | - **1,211,000** stock options were granted during the six months ended June 30, 2025, with a weighted-average grant date fair value of **$0.87**[37](index=37&type=chunk) - **504,000** restricted stock units valued at **$620,000** were issued to employees during the six months ended June 30, 2025, vesting on the earlier of a partnership or December 31, 2025[40](index=40&type=chunk) [6. Common Stock Warrants](index=18&type=section&id=6.%20Common%20Stock%20Warrants) The number of common stock warrants outstanding increased slightly from December 31, 2024, to June 30, 2025, with new grants and some forfeitures. The weighted average exercise price remained stable Common Stock Warrant Activity | Metric | Shares | Weighted Average Exercise Price | | :-------------------------- | :------- | :------------------------------ | | Outstanding, Dec 31, 2024 | 9,595,940| $4.22 | | Granted | 220,000 | $3.00 | | Forfeited/cancelled | (111,510)| $3.00 | | Outstanding, June 30, 2025 | 9,704,430| $4.20 | - The weighted average expiration of warrants outstanding as of June 30, 2025, is **1.6 years**[46](index=46&type=chunk) [7. Loss Per Share](index=18&type=section&id=7.%20Loss%20Per%20Share) Basic and diluted net loss per common share decreased for the six months ended June 30, 2025, compared to 2024. A significant number of potential common shares from warrants, options, convertible notes, and preferred stock were anti-dilutive and thus excluded from diluted EPS calculation Net Loss Per Common Share | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss per common share — basic and diluted | $(0.27) | $(0.39) | Anti-Dilutive Shares (shares) | Instrument | June 30, 2025 | June 30, 2024 | | :------------------------------------------------ | :------------ | :------------ | | Warrants to purchase shares of common stock | 9,704,430 | 9,426,853 | | Options to purchase shares of common stock | 7,541,818 | 7,369,758 | | Restricted stock units | 496,520 | 408,000 | | Shares from convertible notes payable – related party | 7,327,374 | 6,721,188 | | Shares from convertible line of credit – related party | 29,621,834 | 21,016,837 | | Shares from preferred stock conversion | 495,007 | 499,174 | | Total Anti-Dilutive Shares | 55,186,983 | 45,441,810 | [8. Common Stock](index=18&type=section&id=8.%20Common%20Stock) The company issued 419,904 shares of common stock under its At Market Issuance Sales Agreement for net proceeds of $1,218,000 during the quarter ended June 30, 2025. Additionally, shares were issued for preferred stock dividends and conversions - **419,904** shares of common stock were issued under the 2020 At Market Agreement for net proceeds of approximately **$1,218,000** during the quarter ended June 30, 2025[49](index=49&type=chunk) - No shares were issued under the 2020 At Market Agreement during the quarter ended June 30, 2024[49](index=49&type=chunk) - **25,000** shares of Series A Convertible Preferred Stock were converted into **4,167** shares of common stock during the three months ended June 30, 2025[50](index=50&type=chunk) [9. Convertible Line of Credit – Related Party and Supplemental Convertible Lines of Credit – Related Party](index=19&type=section&id=9.%20Convertible%20Line%20of%20Credit%20%E2%80%93%20Related%20Party%20and%20Supplemental%20Convertible%20Lines%20of%20Credit%20%E2%80%93%20Related%20Party) The company has multiple convertible lines of credit from a related party, totaling $81 million, with various draws made and associated warrants issued. All maturity dates for these lines of credit were extended to September 30, 2026. Interest rates vary, and the principal and accrued interest are convertible into common stock at the lender's option - The original Line of Credit (July 2022) provided up to **$60 million**, with its maturity extended to **September 30, 2026**[51](index=51&type=chunk)[52](index=52&type=chunk)[103](index=103&type=chunk) - Several promissory notes were executed under this line, each for **$10 million**, with associated warrants issued to the lender[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) - New supplemental lines of credit were established in March 2024 (**$10M**), November 2024 (**$6M**), and March 2025 (**$5M**), with draws made and warrants issued under each[69](index=69&type=chunk)[76](index=76&type=chunk)[82](index=82&type=chunk) - Accrued interest on these lines of credit increased significantly from December 31, 2024, to June 30, 2025, reflecting ongoing borrowings[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk)[73](index=73&type=chunk)[80](index=80&type=chunk) [10. Segments](index=24&type=section&id=10.%20Segments) The company operates as a single segment focused on fibrotic disease therapeutics, with no product revenue. The Chief Executive Officer, as CODM, assesses performance based on net loss, net cash used in operating activities, and cash on hand, using cash forecast models for resource allocation - The Company's operations are viewed as one operating segment, focused on creating new therapies for fibrotic disease based on targeting galectin proteins[89](index=89&type=chunk) - The Company has not generated any product revenue and expects to incur significant expenses and operating losses for the foreseeable future[91](index=91&type=chunk) Segment Operating Results (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Total operating expenses | $12,522 | $20,939 | | Total operating loss | $(12,522) | $(20,939) | | Net loss | $(17,152) | $(23,860) | | Net cash used in operating activities | $(14,300) | $(20,400) | [11. Commitments and Contingencies](index=25&type=section&id=11.%20Commitments%20and%20Contingencies) The company has no significant pending legal proceedings and accrues for contingencies when probable and estimable. Clinical trial and research commitments are generally cancellable with 30 days' notice, and the company is negotiating with a contract vendor for clinical trial management services - There are no significant pending legal proceedings[98](index=98&type=chunk) - Agreements with contractors for R&D activities are generally cancellable with **thirty days' notice**[99](index=99&type=chunk) - The Company has accrued its estimate of the amount owed to a contract vendor for clinical trial management services[99](index=99&type=chunk) [12. Leases](index=26&type=section&id=12.%20Leases) The company has one operating lease for office space, renewed in March 2025 for twelve months. The lease liability and right-to-use asset are $52,000 as of June 30, 2025 - The Company renewed its office space lease in March 2025 for **twelve months**, effective March 1, 2022[100](index=100&type=chunk) Operating Lease Maturity (in thousands) | Year | Amount | | :--- | :----- | | 2025 | $33 | | 2026 | $22 | | Total| $55 | | Less imputed interest | $(3) | | Present value of lease liability | $52 | - The discount rate used for lease payments is **14%**[101](index=101&type=chunk) [13. Galectin Sciences LLC](index=26&type=section&id=13.%20Galectin%20Sciences%20LLC) Galectin Therapeutics Inc. co-owns Galectin Sciences LLC, a joint venture for galectin-3 inhibitor research. The company's ownership increased to 85.4% as of June 30, 2025, due to disproportionate funding contributions, and it accounts for the LLC as a consolidated, less than wholly owned subsidiary - Galectin Sciences LLC is a collaborative joint venture co-owned by SBH Sciences, Inc., focused on researching and developing small organic molecule inhibitors of galectin-3[102](index=102&type=chunk) - As of June 30, 2025, the Company's ownership percentage in the LLC was **85.4%**, up from an initial **50%**, due to providing more funding[102](index=102&type=chunk) - The Company has contributed a total of **$4,166,000** to the LLC cumulatively as of June 30, 2025[102](index=102&type=chunk) [14. Subsequent Event](index=26&type=section&id=14.%20Subsequent%20Event) On July 8, 2025, the company secured a new $10 million Supplemental Line of Credit from its chairman, Richard E. Uihlein, extending the maturity dates of all existing convertible notes and lines of credit to September 30, 2026. This new line also includes the issuance of warrants to the lender - On July 8, 2025, the Company entered into a new **$10 million** Supplemental Line of Credit with Richard E. Uihlein[103](index=103&type=chunk) - The maturity dates of all Convertible Notes Payable – Related Party and all borrowings under Convertible Lines of Credit – Related Party were extended to **September 30, 2026**[103](index=103&type=chunk) - In connection with this new line, the Company agreed to issue warrants to purchase up to **200,000** shares of common stock to the lender[106](index=106&type=chunk)[107](index=107&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operations, focusing on its clinical-stage drug development, particularly belapectin for NASH and cancer, and financial performance for Q2 2025, including R&D, G&A, and liquidity [Overview](index=29&type=section&id=Overview) Galectin Therapeutics is a clinical-stage biopharmaceutical company developing therapies for fibrotic diseases and cancer by targeting galectin proteins, particularly galectin-3. Its lead candidate, belapectin, is in development for NASH cirrhosis (NAVIGATE trial results presented) and cancer immunotherapy (Phase 2 trial planned for head and neck cancer) - The company is a clinical stage biopharmaceutical company focused on developing new therapies for fibrotic disease, cancer, and other conditions by targeting galectin proteins[112](index=112&type=chunk) - Belapectin (GR-MD-02) is the lead galectin-3 inhibitor, demonstrated in preclinical models to reverse liver fibrosis and cirrhosis, and in clinical studies to decrease portal hypertension[113](index=113&type=chunk) - Top-line results from the NAVIGATE Phase 2b/3 clinical trial for NASH cirrhosis showed a **49.3%** reduction in varices incidence in the per-protocol population (p<0.05) and a **68.1%** reduction in U.S. completer patients (p=0.02) for the belapectin **2 mg/kg** dose group[115](index=115&type=chunk)[140](index=140&type=chunk) - A Phase 2 trial for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint inhibitor is planned, pending financing[121](index=121&type=chunk)[152](index=152&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses decreased significantly for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by a substantial reduction in research and development expenses due to the conclusion of the NAVIGATE clinical trial. General and administrative expenses also saw a modest decrease Operating Expenses (in thousands) | Expense Category | 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 | $3,261 | $9,813 | -67% | $9,746 | $17,867 | -45% | | General and administrative | $1,364 | $1,478 | -8% | $2,776 | $3,072 | -10% | | Total operating expenses | $4,625 | $11,291 | -59% | $12,522 | $20,939 | -40% | - The decrease in research and development expenses is primarily due to lower expenses related to the NAVIGATE clinical trial, which ended in the first quarter of 2025[155](index=155&type=chunk) - General and administrative expenses decreased due to lower stock compensation expense and investor relations/business development expense[158](index=158&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents stood at $13.8 million as of June 30, 2025, supplemented by a new $10 million line of credit, which is expected to fund operations through June 30, 2026. Net cash used in operations decreased, but cash provided by financing activities also declined, indicating a continued need for future capital Liquidity and Cash Flow (in thousands) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------- | :------------ | :------------ | | Cash and cash equivalents | $13,800 | $25,600 | | Net cash used in operations (6 months) | $(14,291) | $(20,438) | | Cash from financing activities (6 months) | $12,942 | $20,376 | - The Company had **$13.8 million** in unrestricted cash and cash equivalents at June 30, 2025, and secured a new **$10 million** line of credit in July 2025[159](index=159&type=chunk) - Management believes current cash and available credit are sufficient to fund operations through **June 30, 2026**, but additional financing will be required thereafter[159](index=159&type=chunk) [Off-Balance Sheet Arrangements](index=39&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements that are reasonably likely to materially affect its liquidity or capital resources - The Company has not created, and is not a party to, any special-purpose or off-balance sheet entities[161](index=161&type=chunk) [Application of Critical Accounting Policies and Estimates](index=39&type=section&id=Application%20of%20Critical%20Accounting%20Policies%20and%20Estimates) The preparation of financial statements requires significant estimates and judgments, particularly concerning accrued expenses, stock-based compensation, and contingencies. Critical accounting policies include stock-based compensation, accrued expenses, and income taxes - Critical accounting policies include stock-based compensation, accrued expenses, and income taxes[163](index=163&type=chunk) - Estimates are based on historical experience, contract terms, industry trends, and other factors, with actual results potentially differing under various assumptions[162](index=162&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk exposure is to changes in U.S. interest rates. However, due to its short-term investments in operating bank accounts and money market funds, the company believes it is not subject to any material market risk - The primary market risk is the risk of loss due to changes in U.S. interest rates[164](index=164&type=chunk) - The Company maintains its cash and cash equivalents in operating bank accounts and money market funds[164](index=164&type=chunk) - Due to the short-term duration of investments, the Company believes it is not subject to any material market risk exposure[164](index=164&type=chunk) [ITEM 4. Controls and Procedures](index=40&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2025**[165](index=165&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[167](index=167&type=chunk) - Management acknowledges that no control system can provide absolute assurance against all errors and fraud[166](index=166&type=chunk) [PART II — OTHER INFORMATION](index=40&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [ITEM 1. Legal Proceedings](index=40&type=section&id=ITEM%201.%20Legal%20Proceedings) There are no significant pending legal proceedings to report - No significant pending legal proceedings are reported[169](index=169&type=chunk) [ITEM 1A. Risk Factors](index=40&type=section&id=ITEM%201A.%20Risk%20Factors) The company refers readers to the comprehensive list of risk factors detailed in its Annual Report on Form 10-K for the year ended December 31, 2024, which could materially impact its business, financial condition, or future results - Readers are directed to the risk factors in the Annual Report on Form 10-K for the year ended December 31, 2024[170](index=170&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&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 - No unregistered sales of equity securities or use of proceeds to report[171](index=171&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=40&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - No defaults upon senior securities to report[171](index=171&type=chunk) [ITEM 4. Mine Safety Disclosures](index=40&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable[171](index=171&type=chunk) [ITEM 5. Other Information](index=40&type=section&id=ITEM%205.%20Other%20Information) The company announced its 2025 Annual Meeting of Stockholders will be a virtual meeting on December 3, 2025, and provided updated deadlines for stockholder proposals and nominations. Additionally, all three executive officers adopted Rule 10b5-1 trading arrangements during the quarter - The 2025 Annual Meeting of Stockholders is scheduled for **December 3, 2025**, as a virtual meeting[171](index=171&type=chunk) - Stockholder proposals for inclusion in the proxy statement must be received by **September 1, 2025**[173](index=173&type=chunk) - All three executive officers adopted Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025[176](index=176&type=chunk) [ITEM 6. Exhibits](index=41&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications, XBRL taxonomy documents, and the interactive data file - Exhibits include Certifications Pursuant to Rule 13a-14(a) and 18 U.S.C. Section 1350[177](index=177&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are also included[177](index=177&type=chunk)[178](index=178&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) The report is duly signed on behalf of Galectin Therapeutics Inc. by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer, on August 14, 2025 - The report was signed by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer[183](index=183&type=chunk) - The signing date for the report was **August 14, 2025**[182](index=182&type=chunk)

Core Viewpoint - Galectin Therapeutics Inc. has secured a new $10 million unsecured line of credit from Richard E. Uihlein, the Chairman and largest individual stockholder, to support its MASH cirrhosis program and ongoing operations [1][2]. Financial Details - The new credit line allows borrowings at the company's discretion until April 30, 2026, with an interest rate of 6.05% (4.05% plus 2%) [2]. - Principal and interest are due on September 30, 2026, and can be converted into shares at a minimum price of $3.00 per share [2]. - Up to 200,000 stock purchase warrants will be issued to Mr. Uihlein, with exercise prices ranging from $3.00 to $10.00 per share [2]. Existing Financial Obligations - The maturity dates for three existing $10 million convertible notes payable to Mr. Uihlein and $81 million in borrowings under other lines of credit have been extended to September 30, 2026 [3]. Company Strategy and Development - The financing is expected to cover projected expenditures through June 2026, allowing the company to focus on its NAVIGATE trial and potential FDA presentations [4]. - The company is actively seeking partnerships to support the development and commercialization of its lead drug, belapectin, for MASH cirrhosis and portal hypertension [4][5]. Product Information - Galectin Therapeutics is focused on developing therapies for chronic liver disease and cancer, with belapectin being its lead drug targeting galectin-3, which is involved in various diseases [5]. - The company has received Fast Track designation from the FDA for belapectin, which is aimed at treating MASH cirrhosis, a significant unmet medical need [5].

Belapectin for MASH Cirrhosis and Portal Hypertension - Belapectin, a galectin-3 inhibitor, has shown potential in reducing galectin-3 expression and fibrogenic activity in preclinical studies[7] - A Phase 2b trial (GT-026) indicated that Belapectin at a 2 mg dose significantly improved portal pressure (HVPG) and reduced the incidence of esophageal varices in patients without baseline varices at 52 weeks[7] - There are currently no FDA-approved therapies to reverse fibrosis in MASH cirrhosis, highlighting a significant unmet need[7] Market Opportunity and Patient Landscape - MASH cirrhosis affects an estimated 3%-5% of the global population and is considered underdiagnosed[14] - In the U S, approximately 5 million people progress to MASH cirrhosis, with 3.3 million having cirrhosis and portal hypertension[16] - The addressable market in the U S for compensated MASH cirrhosis is significant, with peak Belapectin sales estimated at $18 billion[28] NAVIGATE Trial Results - The NAVIGATE trial design involved randomizing 357 patients with MASH cirrhosis and no varices at baseline into three groups: Placebo, Belapectin 2 mg/kg/LBM, and Belapectin 4 mg/kg/LBM[37] - In the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of varices compared to placebo (11 3% vs 22 3%, p=0 04)[48] - In the U S subgroup of the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of new esophageal varices compared to placebo (6 7% vs 21 0%, p=0 02)[56] - The study showed a favorable safety profile for Belapectin, with adverse events and discontinuation rates comparable to placebo[59]

Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]

Company Overview - Galectin Therapeutics Inc. is focused on developing therapeutics targeting galectin-3 for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension [1][8] - The lead drug, belapectin, is a carbohydrate-based drug that inhibits galectin-3, which is involved in inflammatory, fibrotic, and malignant diseases [8] Upcoming Event - A virtual key opinion leader (KOL) event is scheduled for June 16, 2025, to discuss the unmet needs and treatment landscape for MASH cirrhosis and portal hypertension [1][2] - The event will feature results from the NAVIGATE Phase 3 clinical trial evaluating belapectin for MASH cirrhosis and portal hypertension, highlighting its potential as the first treatment for this condition [2] Clinical Significance - There are currently no approved therapies to prevent or treat varices in MASH cirrhosis, making belapectin a significant potential treatment option [2] - The event will include a live Q&A session following the presentations, allowing for further discussion on the findings [3] Key Opinion Leaders - Featured KOLs include Dr. Naga P. Chalasani, a prominent figure in gastroenterology and hepatology, and Dr. Naim Alkhouri, an expert in MASH therapeutics [4][5][7] - Both KOLs have extensive backgrounds in research and clinical practice, contributing to the credibility of the event and the findings presented [4][5] Research and Development Focus - Galectin Therapeutics is dedicated to addressing significant medical needs in chronic liver disease and cancer, with belapectin being central to its development program [8] - The company is also exploring additional development programs in combination immunotherapy for advanced cancers, dependent on finding suitable partnerships [8]

Core Viewpoint - Galectin Therapeutics reported promising results for its lead drug belapectin in treating MASH-associated liver cirrhosis and portal hypertension, highlighting significant clinical efficacy and potential as a new treatment option [2][3][4]. Financial Highlights - As of March 31, 2025, the company had $7.4 million in cash and cash equivalents and $11 million available under credit lines [12]. - Research and development expenses for Q1 2025 were $6.5 million, down from $8.1 million in Q1 2024, primarily due to timing of expenditures related to the NAVIGATE clinical trial [12]. - General and administrative expenses decreased to $1.4 million in Q1 2025 from $1.6 million in Q1 2024 [12]. - The net loss applicable to common stockholders for Q1 2025 was $9.6 million, or ($0.15) per share, compared to a net loss of $11.5 million, or ($0.19) per share in Q1 2024 [12][20]. Clinical Trial Results - The NAVIGATE trial demonstrated that the 2 mg/kg dose of belapectin significantly reduced the incidence of new varices compared to placebo, validating earlier Phase 2 findings [2][3]. - Liver stiffness measurements (LSM) showed statistically significant reductions in the belapectin 2 mg/kg treatment arm at Weeks 26, 52, and 78 [11][20]. - The analysis indicated that 64% more patients in the placebo group experienced an absolute increase in LSM of >10 kPa compared to the 2 mg/kg group, reinforcing the treatment's efficacy [8][11]. Belapectin Program Highlights - Belapectin targets galectin-3, a protein involved in the pathogenesis of MASH and fibrosis, and has received Fast Track Designation from the FDA [5][16]. - The NAVIGATE trial is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin for preventing esophageal varices in MASH cirrhosis [7][20]. Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting MASH-related fibrosis [16].

[Executive Summary and Business Update](index=1&type=section&id=Executive%20Summary%20and%20Business%20Update) Galectin Therapeutics reported Q1 2025 financial results and a business update, highlighting positive clinical findings for belapectin from the NAVIGATE trial [Report Overview](index=1&type=section&id=Report%20Overview) Galectin Therapeutics reported its financial results and provided a business update for the three months ended March 31, 2025, focusing on the advancement of its lead therapeutic, belapectin - Galectin Therapeutics (NASDAQ: GALT) reported **Q1 2025 financial results** and a business update[1](index=1&type=chunk) - The company is a leading developer of therapeutics targeting **galectin proteins**[1](index=1&type=chunk) [CEO and CMO Commentary](index=1&type=section&id=CEO%20and%20CMO%20Commentary) CEO Joel Lewis and CMO Khurram Jamil highlighted positive feedback and significant clinical findings for belapectin from the NAVIGATE trial, presented at EASL. Key results include a clinically significant response in liver stiffness (Fibroscan®) and a reduction in new varices, particularly medium and large ones, reinforcing belapectin's potential as a treatment for MASH-associated liver cirrhosis and portal hypertension - CEO Joel Lewis emphasized continued focus on advancing belapectin analyses and **positive feedback from EASL**[2](index=2&type=chunk) - CMO Khurram Jamil noted that approximately **double the number of patients on placebo showed worsening liver stiffness** compared to belapectin[4](index=4&type=chunk) - The **2 mg/kg dose of belapectin** led to a significantly lower incidence of new varices compared to placebo, primarily driven by a reduction in **medium and large varices**[2](index=2&type=chunk)[4](index=4&type=chunk) - Belapectin has **Fast Track Designation**, supporting its potential as the first targeted treatment for **MASH cirrhosis and portal hypertension**[5](index=5&type=chunk) [Belapectin Program Details](index=3&type=section&id=Belapectin%20Program%20Details) This section details belapectin's mechanism of action, the design of the NAVIGATE Phase 2b/3 trial, and comprehensive clinical results demonstrating its efficacy [Drug Mechanism and Development Status](index=3&type=section&id=Drug%20Mechanism%20and%20Development%20Status) Belapectin is a carbohydrate-based drug designed to inhibit galectin-3, a protein central to the pathogenesis of MASH and fibrosis. It holds Fast Track designation from the FDA for MASH with cirrhosis - Belapectin is a complex carbohydrate drug targeting **galectin-3**, a protein critical in **MASH and fibrosis pathogenesis**[6](index=6&type=chunk) - Belapectin has **Fast Track designation** by the U.S. Food and Drug Administration for **MASH with cirrhosis**[15](index=15&type=chunk) [NAVIGATE Phase 2b/3 Trial Design](index=3&type=section&id=NAVIGATE%20Phase%202b%2F3%20Trial%20Design) The NAVIGATE trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled Phase 2b/3 study. It evaluates the efficacy and safety of intravenous belapectin (2 mg/kg or 4 mg/kg LBM) administered every other week for 18 months to prevent esophageal varices in MASH cirrhosis patients - NAVIGATE is a **global, randomized, double-blind, placebo-controlled Phase 2b/3 trial**[7](index=7&type=chunk) - The trial evaluates belapectin (**2 mg/kg or 4 mg/kg LBM**) every other week for **18 months** for the prevention of **esophageal varices in MASH cirrhosis**[7](index=7&type=chunk) [Detailed Clinical Results](index=3&type=section&id=Detailed%20Clinical%20Results) Detailed analysis of the NAVIGATE trial, including biomarker data presented at EASL, showed statistically significant reductions in liver stiffness (LSM) from baseline in the belapectin 2 mg/kg arm at Weeks 26, 52, and 78. The 2 mg/kg group also demonstrated significantly fewer patients experiencing worsening liver stiffness compared to placebo, with a notable reduction in the incidence of new varices - **Statistically significant reductions in liver stiffness** from baseline were observed in the **belapectin 2 mg/kg treatment arm** at **Week 26, Week 52, and Week 78**[7](index=7&type=chunk) - Belapectin **2 mg/kg treatment** may lead to **regression of liver stiffness** in high-risk MASH populations, while placebo-treated patients showed no improvement[8](index=8&type=chunk) - Significantly fewer patients (**51% fewer**) in the **belapectin 2 mg/kg group** experienced **>30% worsening in liver stiffness** compared to placebo (p=0.03)[10](index=10&type=chunk) Liver Stiffness Worsening (NAVIGATE Trial) | | placebo | 2 mg/kg belapectin | 4mg/kg belapectin | |---|---|---|---| | N= | 88 | 94 | 87 | | >10 increase in kPa from baseline | 11 (12.5%) | 4 (4.3%) | 9 (10.3%) | | >30% increase from baseline | 21 (23.9%) | 11 (11.7%) | 13 (14.9%) | | >10 kPa + 30% increase from baseline | 10 (11.4%) | 4 (4.3%) | 9 (10.3%) | LSM Mean Change from Baseline (Belapectin 2 mg/kg) | Time Point | LSM Mean Change from Baseline | p-value | |---|---|---| | Week 26 | -3.48 | 0.005 | | Week 52 | -4.60 | < 0.0001 | | Week 78 | -2.72 | 0.0197 | [Financial Performance](index=5&type=section&id=Financial%20Performance) This section provides an overview of Galectin Therapeutics' Q1 2025 financial results, including a reduced net loss, detailed statements of operations, and key balance sheet data [Q1 2025 Financial Summary](index=5&type=section&id=Q1%202025%20Financial%20Summary) Galectin Therapeutics reported a net loss applicable to common stockholders of $9.6 million, or ($0.15) per share, for Q1 2025, an improvement from $11.5 million, or ($0.19) per share, in Q1 2024. The company had $7.4 million in cash and equivalents and access to an additional $11 million in credit, sufficient to fund operations through August 2025. Research and development expenses decreased due to the timing of NAVIGATE trial expenditures Q1 2025 Financial Highlights (in millions) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | |---|---|---|---| | Cash and Cash Equivalents | $7.4 | N/A | N/A | | R&D Expenses | $6.5 | $8.1 | -$1.6 (Decrease) | | G&A Expenses | $1.4 | $1.6 | -$0.2 (Decrease) | | Net Loss Applicable to Common Stockholders | $9.6 | $11.5 | -$1.9 (Improvement) | | Basic and Diluted Net Loss Per Share | ($0.15) | ($0.19) | $0.04 (Improvement) | - The company believes it has sufficient cash to fund planned operations and R&D activities through **August 2025**, supplemented by **$11 million available under lines of credit**[11](index=11&type=chunk) - The decrease in R&D expenses was primarily due to the **timing of expenditures related to the NAVIGATE clinical trial**[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations show a reduced net loss for Q1 2025 compared to Q1 2024, driven by lower operating expenses and a decrease in interest expense and change in fair value of derivatives Condensed Consolidated Statements of Operations (Three Months Ended March 31, in thousands) | Metric (in thousands) | 2025 | 2024 | |---|---|---| | Research and development | $6,485 | $8,054 | | General and administrative | $1,412 | $1,594 | | Total operating expenses | $7,897 | $9,648 | | Total operating loss | ($7,897) | ($9,648) | | Interest income | $35 | $80 | | Interest expense | ($1,744) | ($869) | | Change in fair value of derivatives | ($25) | ($1,052) | | Total other income (expense) | ($1,734) | ($1,841) | | Net loss | ($9,631) | ($11,489) | | Preferred stock dividends | $26 | ($8) | | Net loss applicable to common stock | ($9,605) | ($11,497) | | Basic and diluted net loss per share | ($0.15) | ($0.19) | | Shares used in computing basic and diluted net loss per share | 63,204 | 61,976 | [Condensed Consolidated Balance Sheet Data](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of March 31, 2025, the company's cash and cash equivalents decreased significantly from December 31, 2024. Total assets also declined, while total current liabilities saw a substantial increase Condensed Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2025 | December 31, 2024 | |---|---|---| | Cash and cash equivalents | $7,431 | $15,120 | | Total assets | $9,528 | $17,495 | | Total current liabilities | $110,840 | $35,409 | | Total liabilities | $121,789 | $120,565 | | Total redeemable, convertible preferred stock | $1,723 | $1,723 | | Total stockholders' equity (deficit) | ($113,984) | ($104,793) | [Corporate Information](index=6&type=section&id=Corporate%20Information) This section provides an overview of Galectin Therapeutics, outlines the nature of forward-looking statements, and lists key company contacts [About Galectin Therapeutics](index=6&type=section&id=About%20Galectin%20Therapeutics) Galectin Therapeutics is dedicated to developing novel therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting galectin-3 for MASH cirrhosis. The company seeks partnerships for its additional clinical programs in cancer immunotherapy - Galectin Therapeutics focuses on developing therapies for **chronic liver disease and cancer**[15](index=15&type=chunk) - Belapectin, the lead drug, inhibits the **galectin-3 protein** involved in inflammatory, fibrotic, and malignant diseases[15](index=15&type=chunk) - Additional development programs in **cancer immunotherapy** are largely dependent on finding suitable partners[15](index=15&type=chunk) [Forward-Looking Statements](index=7&type=section&id=Forward-Looking%20Statements) The report contains forward-looking statements regarding future events and financial performance, which are subject to risks and uncertainties. These include the potential for belapectin to become the first MASH cirrhosis therapy, success in cancer immunotherapy, and the ability to secure partnerships or additional capital. Actual results may differ materially due to various factors, and management disclaims any obligation to update these statements - Statements regarding future events and financial performance are **forward-looking** and subject to **risks and uncertainties**[17](index=17&type=chunk) - Factors that could cause actual performance to differ include **trial data not being positive, failure to obtain approvals, manufacturing challenges, and inability to secure partnerships or capital**[17](index=17&type=chunk) [Company Contacts](index=8&type=section&id=Company%20Contacts) Contact information for the company's Chief Financial Officer and Investor Relations is provided for inquiries - Company contact: **Jack Callicutt, Chief Financial Officer** (678) 620-3186, ir@galectintherapeutics.com[18](index=18&type=chunk) - Investor Relations contact: **Kevin Gardner**, kgardner@lifesciadvisors.com[18](index=18&type=chunk)

Clinical Trials and Efficacy - The company has completed randomizations totaling 357 patients in the NAVIGATE trial, a Phase 2b/3 clinical study evaluating the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients [97]. - In the intent-to-treat population (N=355), the incidence of varices was reduced by 43.2% in the belapectin 2 mg/kg dose group compared to placebo, although the composite endpoint did not reach statistical significance [98]. - In the per-protocol population (n=287), the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg dose group, with a p-value of less than 0.05 [98]. - In the U.S. cohort (n=186), the incidence of varices was significantly reduced by 68.1% in patients treated with belapectin 2 mg compared to placebo (4 out of 60 vs 13 out of 62) [98]. - The Phase 2b NASH-CX trial enrolled 162 patients with compensated cirrhosis and portal hypertension, evaluating belapectin's safety and efficacy [113]. - In the NASH-CX trial, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose, compared to a 0.3 mm Hg change in placebo [114]. - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01) [115]. - The NASH-CX trial demonstrated a 0% incidence of new varices in the 2 mg/kg LBM group compared to 18% in the placebo group, indicating a significant clinical benefit [117]. - The NAVIGATE trial reported a 43.2% reduction in the incidence of varices in the belapectin 2 mg/kg group compared to placebo, although the composite endpoint did not reach statistical significance [122]. - In the per-protocol population of the NAVIGATE trial, the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg group (p<0.05) [122]. - The NAVIGATE trial showed a significant reduction of 68.1% in the incidence of varices in U.S. patients treated with belapectin 2 mg/kg (p=0.02) [122]. Safety Profile - The safety profile of belapectin remains encouraging, with rates of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported in the NAVIGATE trial [99]. - The safety profile of belapectin in the NAVIGATE trial was comparable to placebo, with no drug-related serious adverse events reported [123]. - The Hepatic Impairment Study indicated that belapectin exposure did not increase with the degree of hepatic insufficiency, supporting its safety profile [130]. Financials and Expenses - Research and development expenses for Q1 2025 were $8,054,000, a decrease of $1,569,000 or 19.5% compared to Q1 2024 [136]. - Clinical activities expenses decreased from $5,872,000 in Q1 2024 to $4,466,000 in Q1 2025, primarily due to the timing of expenditures related to the NAVIGATE clinical trial [137]. - General and administrative expenses decreased by $182,000 or 11.4%, from $1,594,000 in Q1 2024 to $1,412,000 in Q1 2025 [140]. - As of March 31, 2025, the company had $7.4 million in unrestricted cash and cash equivalents, with an additional $11 million available under two lines of credit [141]. - Net cash used in operations decreased by $4,415,000 to $7,689,000 for Q1 2025 compared to $12,105,000 for Q1 2024 [142]. - The company has raised a net total of $314.5 million from public and private offerings since its inception [141]. Product Development and Future Plans - The company has a lead product candidate, belapectin, which has shown promise in treating liver fibrosis, severe skin disease, and cancer, particularly focusing on NASH cirrhosis and head and neck cancer [107]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND with the FDA for advanced or metastatic head and neck cancer in combination with a PD-1 inhibitor [104]. - The company plans to file a Phase 2 trial with the FDA for belapectin in combination with an immune checkpoint inhibitor targeting recurrent or metastatic head and neck cancer [134]. - The company continues to analyze data from approximately 55 patients who completed 36 months of treatment, which may attract interest from potential strategic partners [100]. - The company has established a joint venture subsidiary, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding the uses of galectin-3 inhibitors beyond belapectin [103]. Combination Therapies - The Phase 1b trial combining belapectin with pembrolizumab (KEYTRUDA) showed a 50% objective response rate in advanced melanoma and a 33% response rate in head and neck cancer patients [133]. - The combination of belapectin with pembrolizumab may reduce autoimmune side effects associated with pembrolizumab [133]. Challenges and Limitations - The company is unable to provide accurate estimates for the costs and timing of bringing a drug candidate to market due to numerous variables [138].

Data presentation included efficacy and biomarker analyses from the NAVIGATE trial (n=287). Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). Significantly fewer patients in the belapectin treatment arms experienced worsening of liver stiffness as measured by FibroScan®, reinforcing the potential beneficial effect of belapectin in halting the progression of MASH cirrhosis. NORCROSS, Ga., May 12, 2025 (GLOBE NEWSWIRE) -- ...

Core Insights - Galectin Therapeutics Inc. is set to present data from its NAVIGATE study on belapectin, a galectin-3 inhibitor, at the EASL 2025 meeting, highlighting its significance in the hepatology community [1][2] - The NAVIGATE study focuses on patients with MASH cirrhosis and portal hypertension, conditions that have been historically overlooked despite their severe impact on patients [2] - The company is also analyzing biomarker data from the NAVIGATE study, with additional results expected to be shared in the second quarter of 2025 [2] Company Overview - Galectin Therapeutics is dedicated to developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3, which is involved in various inflammatory and fibrotic diseases [3] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily focused on treating metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, representing a significant drug development opportunity [3] - The company is also exploring additional development programs in cancer immunotherapy, contingent on finding suitable partnerships for efficient development [3]