Galectin Therapeutics Inc. · NASDAQ:GALT

Galectin Therapeutics — Investor Presentation (March 2025)

33 slides from Galectin Therapeutics's investor presentation, Mar 5, 2025

  1. Slide 1: Galectin Therapeutics Corporate Overview February 2025

    Galectin TherapeuticsCorporate OverviewFebruary 2025

  2. Slide 2: Forward-Looking Statements

    2 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,” “expe

  3. Slide 3: Investment Highlights

    Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track Designation Low toxicity as a carbohydrate-based molecule which is degraded by natural processes Patent protection through 2032 Only company to exclusively focus on treatment for MASH cirrhosis and portal hypertension Significant ef

  4. Slide 4: Highly Experienced Leadership Team

    Highly Experienced Leadership Team 4 Over 32 years of public and private company experience including more than a decade of audit, tax and SEC registrant experience with a major accounting firm. JACK W. CALLICUTT Chief Financial Officer Over 28 years of experience working in the pharmaceutical indus

  5. Slide 5: Laser-Focused Pipeline

    Clinical Program Development Stage Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis Belapectin MASH Cirrhosis and Portal Hypertension Cancer Immunotherapy (Combination therapy) Belapectin + Keytruda Melanoma + Head / Neck Cancer Oral Galectin-3 Inhibitors Discovery program to i

  6. Slide 6: Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases

    Galectin 3 is part of the galectin family of sugar-binding proteins that act as a “molecular glue”, it is: Predominantly produced by activated macrophages Involved in a wide number of biological and pathological processes Galectin-3 recruits macrophages to injury sites and promotes chronic inflammat

  7. Slide 7: Belapectin: a Proprietary Galectin-3 Inhibitor with Low Toxicity and Anti-fibrotic Activity

    Belapectin: a Proprietary Galectin-3 Inhibitor with Low Toxicity and Anti-fibrotic Activity Belapectin is a polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars Belapectin Preclinical Data: In animal models of MASH (streptozotocin Hi

  8. Slide 8: MASH Cirrhosis

    MASH Cirrhosis Galectin gy

  9. Slide 9: MASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment

    MASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment Metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH), is characterized by fat accumulation, inflammation and fibrosis of the liver1 3%-5%

  10. Slide 10: Belapectin is a Novel Therapy with First- and Best-in-Class Potential in MASH Cirrhosis

    10 3rd Party Market Opportunity Assessment Suggests1 Potential 35-100% Adoption Rate Limited current treatment options: Cirrhotic management focuses on stabilization and delaying progression Management directed towards comorbidities Highly favorable perception of belapectin indication, MoA and safet

  11. Slide 11: When to Intervene in Cirrhosis - Before It's Too Late

    HPVG=hepatic venous pressure gradient. There are no approved therapies to reverse portal hypertension once it develops in MASH Cirrhosis When to Intervene in Cirrhosis- before its too late! 11 Compensated cirrhosis Decompensated cirrhosis No Portal Hypertension Portal Hypertension Stage 2 Stage 3 an

  12. Slide 12: Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial

    Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial 12 Placebo n=54 Screen Belapectin 8 mg/kg/LBM Q2W n=54 52 Weeks Belapectin 2 mg/kg/LBM Q2W n=53 Randomize (N=162 1:1:1) Main inclusion criteria MASH cirrhosis (biopsy) Portal Hypertension: HVPG ≥ 6 mmHg No cirrhosis complicat

  13. Slide 13: Belapectin Impact on HVPG at One Year

    Belapectin Impact on HPVG at One Year1,* 13 HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass, N.S.=non significant. *ITT with LOCF, ANCOVA with baseline as covariate and treatment as factors, Bonferroni-Holm.1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45. N.S. N.S. Baseline 1 yr Ba

  14. Slide 14: Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis

    Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis1,* 14 Significantly fewer new varices on belapectin vs placebo No patients on 2 mg/kg/LBM developed new varices Belapectin demonstrated efficacy on a clinically-meaningful endpoint where no current therapies exist LBM=lean body

  15. Slide 15: NAVIGATE Trial: Belapectin for Prevention of Varices in MASH Cirrhosis and Portal Hypertension

    NAVIGATE Trial: Belapectin for Prevention of Varices in Patients with MASH cirrhosis and Portal Hypertension 15 Placebo n=119 Screen Belapectin 2 mg/kg/LBM Q2W n=119 78 Weeks Belapectin 4 mg/kg/LBM Q2W n=119 Randomize (N=357 1:1:1) Patient Population MASH cirrhosis Diagnosis of Portal Hypertension u

  16. Slide 16: NAVIGATE Study: Patient Population and Efficacy Endpoints

    NAVIGATE Study: Patient Population and Efficacy Endpoints 16 MASH cirrhosis No varices on EGD CTP Scores <7 Portal hypertension: Thrombocytopenia or at least AST/ALT > 1 Spleen ≥ 14 cm Collaterals by imaging Stiffness ≥ 20 kPa Development of new varices (composite strategy) in ITT population- Number

  17. Slide 17: NAVIGATE Trial: Baseline Demographics

    NAVIGATE Trial: Baseline demographics © 2014 Galectin Therapeutics | NASDAQ: GALT Baseline Demographics and Clinical Characteristics (N=355) Placebo (N = 118) 2mg/kg LBM (N = 119) 4mg/kg LBM (N = 118) Mean (Standard Deviation) Mean (Standard Deviation) Mean (Standard Deviation) Age (years) 60.4 (8.5

  18. Slide 18: NAVIGATE 18-Month Primary Analyses Result – ITT Population

    NAVIGATE 18-Month Primary Analyses Result – ITT Population © 2014 Galectin Therapeutics | NASDAQ: GALT ITT: Intent to Treat -All randomized subjects Primary end point composite strategy i.e. new varices and or intercurrent events or drop out ICEs (intercurrent events) include; Liver related clinical

  19. Slide 19: Belapectin 2 mg Led to 49% Reduction in Incidence of New Varices

    Belapectin 2 mg Led to 49% Reduction in Incidence of New Varices © 2014 Galectin Therapeutics | NASDAQ: GALT NAVIGATE 18-month Primary Analyses Result; Per protocol population n= 287 N = 97 N = 98 N = 95 Per Protocol: All ITT subjects who completed 18 months of treatment and an end of treatment (EOT

  20. Slide 20: Incidence of New Varices was Significantly Lower in Patients in the U.S.

    Incidence of New Varices was Significantly Lower in Patients in the U.S. © 2014 Galectin Therapeutics | NASDAQ: GALT n=13/62 n=4/60 n=8/64 n=8/32 n=7/37 n=5/ 32 p=0.02 p=0.54 p=0.35 NAVIGATE 18-month; Per protocol population (n=287) p=0.2 20

  21. Slide 21: Use of GLP-1 and Statin was Higher in Patients in the U.S.

    Use of GLP-1 and Statin was Higher in Patients in the U.S. 21 Treatment Group Placebo Belapectin 2mg/kg LBM Belapectin 4mg/kg LBM Total U.S. (N=62) (N=60) (N=64) (N=186) Concomitant Use of GLP-1 n (%) 28 (45.2%) 22 (36.7%) 18 (28.1%) 68 (36.6%) Concomitant Use of NSBBs n (%) 5 (7.9%) 3 (5.0%) 3 (4.6

  22. Slide 22: Numerically Fewer Subjects Showed Worsening in Liver Stiffness Measure

    22 Numerically Fewer Subjects Showed Worsening in Liver Stiffness Measure- LSM (kPa) © 2014 Galectin Therapeutics | NASDAQ: GALT Belapectin Placebo (N = 92) 2mg/kg LBM (N = 93) 4mg/kg LBM (N = 92) Baseline LSM Value (kPA) Mean (SD) 23.3 (11.1) 22.9 (10.6) 24.4 (11.8 ) Median 22.4 21.5 23.4 W78/EOT L

  23. Slide 23: Fewer Subjects Progressed to High-Risk ELF Category

    Fewer Subjects Progressed to High-Risk ELF Category © 2014 Galectin Therapeutics | NASDAQ: GALT ELF Enhanced Liver Fibrosis Score- combined for HA, PIIINP and TIMP-1 ELF: Risk of disease progression. < 9.8 Low risk, ≥11.3 mid risk, highest risk ≥13 Belapectin Placebo 2mg/kg LBM 4mg/kg LBM Baseline E

  24. Slide 24: Lack of Dose Response at Higher Doses of Belapectin

    Lack of Dose Response at Higher Doses of Belapectin in GT-026 were also observed in NAVIGATE trial Based on findings from preclinical and clinical trials to date, Belapectin likely demonstrates target-mediated drug disposition (TMDD) Once Galectin-3 binding sites within macrophages are saturated, ad

  25. Slide 25: Summary of Safety Results

    Summary of safety results Similar proportion of subjects discontinued the study treatment in each arm due to Adverse Events: 7 (5.9%) in the Placebo arm, 6 (5.0%) in the Belapectin 2 mg/Kg arm and 9 (7.5%) in the Belapectin 4 mg/Kg arm. Similar proportion of subjects discontinued the study due to Ad

  26. Slide 26: Assessment of Results

    Assessment of Results Belapectin 2 mg reduced varices incidence by 43.2% compared to placebo in the overall population; results were not statistically significant (ITT). In the per-protocol population (18-month treatment + end-of-treatment EGD), the reduction was 48.9%. Initial sample size assumed 5

  27. Slide 27: Key Takeaways and Next Steps

    Key Takeaways and Next Steps 2 mg dose demonstrated a meaningful reduction in the development of new esophageal varices in patients with MASH cirrhosis and portal hypertension validating the findings observed in GT-026 trial. Non-invasive markers provide supportive evidence showing a lower incidence

  28. Slide 28: Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)

    Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)

  29. Slide 29: Higher Galectin-3 Tumor Levels are Associated with Metastatic Melanoma Progression

    29 Higher Galectin-3 Tumor Levels are Associated with Metastatic Melanoma Progression **p<0.01, ***p<0.001. CR=complete response; HNSCC=head and neck squamous cell carcinoma; MM=metastatic melanoma; PD=progressive disease; PR=partial response; SD=stable disease. 1. Greisen SR, et al. J Immunother Ca

  30. Slide 30: Reduced PD-1 Clearance Correlates with Better Survival in Patients with MM and HNSCC

    Increased progression-free survival in patients with higher trough level of pembrolizum1,* 30 Reduced PD-1 Clearance Correlates with Better Survival in Patients with MM and HNSCC Serum trough levels of pembrolizumab in patients with disease control or progressive disease1 Increased trough levels of

  31. Slide 31: Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 1

    Phase 1 (Investigator-Initiated) of belapectin + pembrolizumab (Keytruda®) Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 11 31 Objective response observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients Extension in more advanced patients showed stable

  32. Slide 32: Investment Highlights

    Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track Designation Low toxicity as a carbohydrate-based molecule which is degraded by natural processes Patent protection through 2032 Only company to exclusively focus on treatment for MASH Cirrhosis and Portal Hypertension Consistent and

  33. Slide 33: Galectin gy

    Galectin gy > fo) > =x c © a= E

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