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, 2022 ☐ 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) (I.R.S. Employer Identification No.) Nevada 04-3562325 4960 Peachtree ...

Corporate Overview October 2022 2022 Galectin Therapeutics | NASDAQ: GALT www.galectintherapeutics.com Forward-looking statements This presentation contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factor ...

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, 2022 ☐ 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 ...

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, 2022 ☐ 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 Peacht ...

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 ...

Table of Contents 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, 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) 4960 Peachtr ...

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].