Product Development - Galectin Therapeutics is focused on developing therapies for fibrotic diseases, cancer, and other conditions, utilizing proprietary complex carbohydrates targeting galectin proteins[54] - The lead product candidate, belapectin, has shown potential in reversing liver fibrosis and cirrhosis, with completed Phase 1 and Phase 2 clinical studies demonstrating its efficacy[55] - A global Phase 2b/3 clinical trial, NAVIGATE, is currently underway to evaluate belapectin for preventing esophageal varices in NASH cirrhosis patients, with patient enrollment starting in Q2 2020[56] - The company has established a joint venture, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding treatment options beyond belapectin[58] - A Phase 2 trial is planned for advanced or metastatic head and neck cancer using belapectin in combination with a PD-1 inhibitor, following previous successful collaborations[59] Clinical Trials - The NASH-FX trial, a Phase 2a pilot study, involved 30 patients and did not meet its primary endpoint but indicated that belapectin was safe and well tolerated[67] - Belapectin has been shown to reduce liver fat, inflammation, and portal pressure in preclinical models, supporting its development for NASH cirrhosis[63] - The NASH-CX trial involved 162 patients with well-compensated NASH cirrhosis and portal hypertension, randomized to receive either belapectin or placebo[68] - In the total patient population, 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 of belapectin, compared to a 0.3 mm Hg change in placebo[69] - 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)[70] - The belapectin 2 mg/kg LBM group had a 0% incidence of new varices, compared to 18% in the placebo group, indicating a significant reduction in the development of esophageal varices[72] - Belapectin demonstrated a statistically significant improvement in hepatocyte ballooning and a reduction in new esophageal varices development (p=0.02) compared to placebo[73] - The NAVIGATE trial is designed to evaluate belapectin's efficacy in preventing esophageal varices in NASH cirrhosis patients, with a primary endpoint focused on the incidence of new varices[76] - The NAVIGATE trial will compare two belapectin doses (2 mg/kg LBM and 4 mg/kg LBM) against placebo, with an interim analysis planned to select the optimal dose[76] - Approximately 140 clinical trial sites have been activated across 15 countries for the NAVIGATE trial[84] - The Company has commenced a Hepatic Impairment Study involving 40 patients to evaluate the effects of cirrhosis on serum belapectin levels[85] - Promising results from a Phase 1b trial combining belapectin with KEYTRUDA showed a 50% objective response rate in advanced melanoma patients[88] Financial Performance - The company has incurred significant operating losses since inception and relies on external capital for continued development[54] - Research and development expenses increased to $8,058,000 for the three months ended March 31, 2022, compared to $4,899,000 in the same period of 2021, representing a 64% increase[92] - Clinical activities accounted for $6,869,000 of the research and development expenses, up from $4,283,000, indicating a significant rise in clinical trial costs[92] - The company had $31.6 million in unrestricted cash and cash equivalents as of March 31, 2022, to fund future operations[96] - Net cash used in operations rose by $1,660,000 to $8,042,000 for the three months ended March 31, 2022, compared to $6,382,000 in the same period of 2021[97] - The company anticipates requiring an additional $40-$45 million to cover costs related to the NAVIGATE Phase 2b/3 clinical trial, expected to reach interim analysis in mid-2024[96] - General and administrative expenses decreased to $1,418,000 for the three months ended March 31, 2022, from $1,877,000 in the same period of 2021, a reduction of 32%[95] - The increase in general and administrative expenses was primarily due to a rise in non-cash stock-based compensation expenses of approximately $446,000[95] - The company has raised a net total of $234.5 million from public and private offerings since its inception[96] - The company has operated at a loss since inception and anticipates that losses will continue for the foreseeable future[96] - The company does not have any off-balance sheet arrangements that could materially affect its liquidity or capital resources[98] Regulatory Environment - The FDA has provided guidance on the NAVIGATE trial, which is designed to confirm previous Phase 2 data and evaluate the risk/benefit of belapectin[56] - Galectin Therapeutics is subject to extensive regulation by the FDA and other authorities, which could impact the commercialization of its product candidates[54]

Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2021 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) (I.R.S. Employer Identification No.) UNITED STATES SECURITIES AND EXCHANGE COMMISSION 4960 Peachtree ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2021 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) (I.R.S. Employer Identification No.) 4960 P ...

[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section provides the company's financial statements and management's analysis of its financial condition and operations [Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, highlighting a net loss of **$14.8 million** and future financing needs - The company is a clinical-stage biopharmaceutical firm focused on therapies for fibrotic disease and cancer by targeting galectin proteins[19](index=19&type=chunk) - The company has operated at a loss since inception and anticipates continued losses, with current cash of **$31.6 million** plus a **$10 million** line of credit expected to fund operations through September 30, 2022, but an additional **$30-$35 million** will be needed for the NAVIGATE trial's interim analysis in the second half of 2023[21](index=21&type=chunk)[98](index=98&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202021%20and%20December%2031%2C%202020) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $31,598 | $27,142 | | Total current assets | $33,334 | $29,465 | | **Total assets** | **$33,405** | **$29,600** | | Total current liabilities | $6,054 | $5,399 | | Convertible note payable - related party | $9,643 | $0 | | **Total liabilities** | **$16,289** | **$5,407** | | **Total stockholders' equity** | **$15,393** | **$22,470** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202021%20and%202020) This section outlines the company's revenues and expenses over specific periods, culminating in its net income or loss Operating Results (in thousands, except per share data) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,450 | $4,681 | $11,349 | $6,825 | | General and administrative | $1,743 | $1,421 | $3,161 | $2,861 | | **Total operating loss** | **($8,193)** | **($6,102)** | **($14,510)** | **($9,686)** | | **Net loss** | **($8,449)** | **($6,114)** | **($14,787)** | **($9,670)** | | Net loss per common share | ($0.15) | ($0.11) | ($0.26) | ($0.17) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202021%20and%202020) This section details the cash inflows and outflows from operating, investing, and financing activities over specific periods Cash Flow Summary for Six Months Ended June 30 (in thousands) | Category | 2021 | 2020 | | :--- | :--- | :--- | | Net cash flows from operating activities | $(12,359) | $(6,975) | | Net cash flows from financing activities | $16,815 | $263 | | **Net increase (decrease) in cash** | **$4,456** | **$(6,712)** | | Cash and cash equivalents, end of period | $31,598 | $40,768 | - Financing activities in the first six months of 2021 included **$10 million** from a convertible note payable, **$6.8 million** from issuance of common stock, and non-cash financing activities related to a derivative liability of **$420,000**[12](index=12&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides additional details and explanations for the figures presented in the financial statements, including significant accounting policies and material transactions - On April 16, 2021, the company received **$10 million** from a convertible promissory note issued to Richard E. Uihlein, Chairman of the Board, which matures in 2025, has a **2% interest rate**, and is convertible at **$5.00 per share**[27](index=27&type=chunk)[28](index=28&type=chunk) - The company has a **$10 million** undrawn line of credit with Richard E. Uihlein, available through December 31, 2021, with repayment due December 31, 2022[25](index=25&type=chunk) - During the six months ended June 30, 2021, the company issued **845,214 shares** of common stock under its "At Market Issuance Sales Agreement" for net proceeds of **$3.9 million**[43](index=43&type=chunk) - The company's ownership in its joint venture, Galectin Sciences, LLC, was **84%** as of June 30, 2021, accounted for as a consolidated, less-than-wholly-owned subsidiary[49](index=49&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business, clinical development, and financial performance, focusing on the belapectin trial and increased R&D expenses, while noting future capital requirements - The company's lead drug candidate is belapectin (GR-MD-02), a galectin-3 inhibitor being developed for NASH with cirrhosis, with the ongoing NAVIGATE trial being a seamless, adaptively-designed Phase 2b/3 study to evaluate belapectin for preventing esophageal varices in these patients[56](index=56&type=chunk)[57](index=57&type=chunk) - The COVID-19 pandemic has delayed patient enrollment for the NAVIGATE trial, with the company now estimating enrollment completion around the end of 2021[83](index=83&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Research and Development | $11,349 | $6,825 | +66% | | General and Administrative | $3,161 | $2,861 | +10% | - The **66% increase** in R&D expenses for the six months ended June 30, 2021, was primarily driven by costs related to the NAVIGATE clinical trial[95](index=95&type=chunk) - As of June 30, 2021, the company had **$31.6 million** in cash and a **$10 million** undrawn line of credit, expected to fund operations through September 30, 2022, but an additional **$30-$35 million** is required to fund the NAVIGATE trial to its interim analysis[98](index=98&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that it is not subject to any material market risk exposure, preserving cash for operations by holding cash and equivalents in bank accounts and money market funds - The company's investment activities aim to preserve cash until required for operations[105](index=105&type=chunk) - To minimize risk, the portfolio of cash and cash equivalents is maintained in operating bank accounts and money market funds, making it not subject to material market risk from interest rate changes[105](index=105&type=chunk) [Controls and Procedures](index=24&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, 2021, with no material changes in internal control over financial reporting during the quarter - Management evaluated disclosure controls and procedures and concluded they were effective as of June 30, 2021[106](index=106&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2021, that materially affected, or are reasonably likely to materially affect, internal controls[108](index=108&type=chunk) [PART II — OTHER INFORMATION](index=25&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, equity sales, and exhibits [Legal Proceedings](index=25&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reported no significant pending legal proceedings as of the filing date - None[110](index=110&type=chunk) [Risk Factors](index=25&type=section&id=ITEM%201A.%20Risk%20Factors) This section directs readers to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2020 - The report refers to the risk factors detailed in Item 1A of the company's Form 10-K for the year ended December 31, 2020[111](index=111&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[112](index=112&type=chunk) [Defaults Upon Senior Securities](index=25&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[112](index=112&type=chunk) [Mine Safety Disclosures](index=25&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[112](index=112&type=chunk) [Other Information](index=25&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information for this item - Not Applicable[112](index=112&type=chunk) [Exhibits](index=25&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, primarily including CEO and CFO certifications and financial data in Inline XBRL format - The exhibits filed include CEO and CFO certifications pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002[112](index=112&type=chunk) - The filing includes financial statements formatted in Inline Extensible Business Reporting Language (Inline XBRL)[112](index=112&type=chunk)[114](index=114&type=chunk)

Table of Contents Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2021 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., Suite 240, Norcross ...

Financial Performance - Net cash used in operations increased by $9,753,000 to $20,601,000 in 2020, compared to $10,848,000 in 2019, driven by higher research and development activities [196]. - The company raised a net total of $197.7 million from public and private offerings since inception, with $27.1 million in unrestricted cash available as of December 31, 2020 [195]. - Other income for 2020 included $66,000 in interest income, offset by $87,000 in interest expense related to debt discount amortization [189]. - The company has not generated any revenue to date and is dependent on additional outside capital for future operations [182]. Research and Development - Research and development expenses increased by 141% from $7,467,000 in 2019 to $17,976,000 in 2020, primarily due to costs related to the NAVIGATE clinical trial [185]. - Clinical program expenses rose from $4,826,000 in 2019 to $14,229,000 in 2020, reflecting increased activities in clinical trials [186]. - The company expects to require an additional $45-$50 million to cover costs for the NAVIGATE Phase 2b/3 clinical trial, with an interim analysis estimated for the second half of 2023 [195]. - The impact of COVID-19 has caused delays in clinical trials and development efforts, affecting the company's operations and capital market access [187]. Administrative Expenses - General and administrative expenses decreased by 8% from $5,971,000 in 2019 to $5,468,000 in 2020, mainly due to reductions in legal and investor relations expenses [188]. Financial Reporting and Estimates - Significant estimates in financial reporting include stock option valuations, accrued liabilities, and deferred income taxes, which require management's judgment [207]. - Research and development expenses are charged as incurred, with significant factors for estimating accruals including patient enrollment and active clinical sites [210]. - Stock-based compensation is measured at grant date fair value and recognized as expense over the service period, including estimates for forfeitures [211]. Liquidity and Capital Resources - The Company has not created any off-balance sheet entities that could materially affect liquidity or capital resources [206]. - The Company is not exposed to significant market risks due to the nature of its operations and absence of debt as of December 31, 2020 [212]. - The Company has not drawn on a $10 million unsecured line of credit available from a stockholder and director [195]. Lease Obligations - The Company entered into a one-year operating lease for office and lab space in Natick, MA, at a rate of $15,000, which has continued on a month-to-month basis since October 1, 2013 [204].

Clinical Development - Galectin Therapeutics is focused on developing belapectin (GR-MD-02) as a treatment for liver fibrosis associated with non-alcoholic steatohepatitis (NASH), with significant preclinical evidence supporting its efficacy[55]. - The company has completed two Phase 1 clinical studies and two Phase 2 clinical trials (NASH-FX and NASH-CX) for belapectin, with top line results from the NASH-CX trial published in Gastroenterology in 2020[55][62]. - A seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, has been initiated to evaluate the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients, with patient enrollment starting in June 2020[58][62]. - Belapectin has shown promise in treating moderate to severe plaque psoriasis and severe atopic dermatitis, with positive interim data reported from early trials[61][63]. - The Phase 2b NASH-CX trial enrolled 162 patients with compensated cirrhosis, randomized to receive either 2 mg/kg or 8 mg/kg of belapectin, or placebo, with a primary endpoint of reducing hepatic venous pressure gradient (HVPG)[68]. - In the total patient population, the mean change in HVPG from baseline was -0.37 mm Hg for the 2 mg/kg dose and -0.42 mm Hg for the 8 mg/kg dose, compared to a 0.3 mm Hg change in placebo[69]. - In patients without varices at baseline, the 2 mg/kg dose of belapectin showed a statistically significant effect on HVPG with a change of -1.08 mm Hg (p<0.01)[70]. - The NASH-CX trial demonstrated a statistically significant reduction in the development of new esophageal varices in drug-treated patients compared to placebo (0% and 4% in the belapectin groups vs 18% in placebo)[72]. - The NASH-RX trial is designed to evaluate the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients, with a primary endpoint focused on the incidence of new varices[76]. - The NASH-RX trial will compare two belapectin doses (2 mg/kg and 4 mg/kg) against placebo, with an interim analysis planned after 18 months of treatment[76]. - A Hepatic Impairment Study will run in parallel with the NASH-RX trial, involving approximately 40 patients to assess the effects of cirrhosis on serum belapectin levels[85]. - Preclinical studies indicate that belapectin enhances immune response against cancer cells, showing increased tumor shrinkage and survival in mice when combined with immune checkpoint inhibitors[86]. - The company has initiated Phase 1B studies of belapectin in combination with Yervoy® and KEYTRUDA in patients with metastatic melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma[86]. - The NASH-CX trial results support further development of belapectin in NASH, with a favorable safety profile and evidence of pharmacodynamic effects[67]. - The Phase 1b trial combining belapectin with pembrolizumab (KEYTRUDA®) showed a 50% objective response rate in advanced melanoma patients[88]. - In the ongoing trial, 14 advanced melanoma patients have data on Objective Response Rate (ORR) and Disease Control Rate (DCR), with cohort 2 showing a 100% ORR[88]. - A patient in the NASH fibrosis trial experienced complete resolution of plaque psoriasis after treatment with belapectin, remaining symptom-free for 17 months[89]. - The Phase 2a trial for moderate to severe plaque psoriasis reported an average improvement of 50% across five patients, with one patient achieving an 82% improvement[91]. Financial Performance - Galectin Therapeutics has incurred significant operating losses since inception and relies on external capital for continued development and commercialization of its product candidates[54]. - Research and development expenses for the three months ended September 30, 2020, increased by 218% to $4,780,000 compared to $1,503,000 in 2019[94]. - General and administrative expenses decreased by 16% to $1,146,000 for the three months ended September 30, 2020, compared to $1,360,000 in 2019[99]. - As of September 30, 2020, the company had $32.6 million in unrestricted cash and cash equivalents available for future operations[100]. - Net cash used in operations increased by $8,098,000 to $15,187,000 for the nine months ended September 30, 2020, compared to $7,089,000 in 2019[101]. - The company anticipates requiring an additional approximately $40 million to cover costs for a planned Phase 2b/3 clinical trial[100]. - Net cash provided by financing activities for the nine months ended September 30, 2020, was $263,000, significantly lower than $49,173,000 in the same period of 2019[102]. Regulatory Environment - The company is subject to extensive regulation by the FDA and other authorities, which could impact the approval and marketing of its products[54]. - The company has received FDA feedback on its clinical trial protocols, which has been incorporated into the study designs to ensure compliance and feasibility[56][58]. Strategic Collaborations - The company has established collaborations with external experts to enhance drug development efficiency and has filed multiple patents for new carbohydrate molecules targeting galectin proteins[59]. - Galectin Therapeutics aims to leverage its scientific expertise and established relationships to achieve cost-effective drug development and expand its product pipeline[59]. Future Directions - Galectin Therapeutics is exploring additional indications for belapectin, including lung and kidney fibrosis, as well as cancer immunotherapy[62][63].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2020 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2020 Securities registered or to be registered pursuant to Section 12(b) of the Act. | | Trading | Name of each exchange | | --- | --- | --- | | Title of each class | Symbol(s) | on which registered | | Common Stock | GALT | Nasdaq | ☐ Transition report pursuant to Section 13 or 1 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2019 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., Suite 240, Norcross ...