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 ...

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 September 30, 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, ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ 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., Suite 240, Norcross, GA 30071 (Address of Principal Executive Offices) (Zip Code) (I.R.S. Employer Identification No.) Washington, D.C. 20549 FORM 10-Q ☒ Quarterly r ...

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, 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. Nevada 04-3562325 (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., Suite 240, Nor ...

Corporate Overview H.C. Wainwright Global Life Sciences Conference London, UK April 9, 2019 NASDAQ: GALT www.galectintherapeutics.com Harold H. Shlevin, Ph.D. Chief Executive Officer 2019 Galectin Therapeutics | NASDAQ: GALT For more information, see 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 event ...

Commission File No. 001-31791 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, 2018 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., S ...