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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549



FORM 8-K



CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):  June 16, 2025



GALECTIN THERAPEUTICS INC.
 (Exact name of registrant as specified in its charter)



Nevada
001-31791
04-3562325
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)

4960 PEACHTREE INDUSTRIAL BOULEVARD, STE 240
NORCROSS, GA 30071
(Address of principal executive office) (zip code)

Registrant’s telephone number, including area code: (678) 620-3186

N/A
(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol
Name of each exchange on which registered
Common Stock $0.001par value per share
GALT
The Nasdaq Stock Market



Item 7.01
Regulation FD Disclosure.

On June 16, 2025, Galectin Therapeutics Inc. (the “Company”) posted to its website the presentation Belapectin for MASH Cirrhosis and Portal Hypertension attached hereto as Exhibit 99.1. A copy of the presentation is furnished herewith as Exhibit 99.1 and incorporated herein by reference.   Additionally, a webcast discussing the presentation will occur on June 16, 2025 at 12:00 p.m. ET and may be accessed (live or replay afterwards) via the following link: https://lifescievents.com/event/galectin/.

In accordance with General Instruction B.2 of Form 8-K, the information furnished under this Item 7.01 of this Current Report on Form 8-K and the exhibits attached hereto are deemed to be “furnished” and shall not be deemed “filed” for the purpose of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall such information and exhibits be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

This Current Report on Form 8-K and Exhibit 99.1 hereto contain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit No.
 
Exhibit Description
 
Galectin Therapeutic Inc. Corporate Presentation, updated June 16, 2025
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, Galectin Therapeutics Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Galectin Therapeutics Inc.



Date: June 16, 2025
By:
 /s/ Jack W. Callicutt
 

 
Jack W. Callicutt
   
Chief Financial Officer


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EX-99.1 2 ef20050576_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 Belapectin for MASH Cirrhosis and Portal Hypertension  June 2025 
 

 Khurram   Today’s Agenda  01  02  03  04  05  06  Moderator Michael Cozart, LifeSci Consulting  Galectin Company Introduction Joel Lewis (CEO & President)  Belapectin as Galectin-3 Inhibitor for MASH cirrhosis & Portal Hypertension Khurram Jamil, M.D. (CMO)  Unmet Need & Patient Landscape Naga Chalasani, M.D.   Clinical Results – NAVIGATE Trial design & Results Naim Alkhouri & Naga Chalasani  Closing Remarks Joel Lewis (CEO & President)  2 
 

 Company introduction  Joel Lewis  CEO & President  
 

 Belapectin as Galectin-3 Inhibitor for MASH cirrhosis & Portal Hypertension  Khurram Jamil, M.D.  Chief Medical Officer  
 

 5  Belapectin for MASH Cirrhosis and Portal Hypertension  Galectin-3, a β-galactoside-binding lectin, is upregulated in fibrosis and promotes fibroblast activation1  Belapectin a galectin-3 inhibitor reduced galectin-3 expression and fibrogenic activity in pre-clinical studies2,3,4  In a phase 2b trial(GT-026), Belapectin 2 mg dose significantly improved portal pressure (HVPG) and reduced the incidence of esophageal varices in patients without baseline varices at 52 week5  Currently no FDA approved therapies exist to reverse fibrosis in MASH cirrhosis  Compensated MASH cirrhosis with portal hypertension remains a high-risk and under served population with significant unmet need. 
 

 Belapectin Preclinical Data:  In animal models of MASH (streptozotocin High-Fat Diet mice1) and cirrhosis (thioacetamide treated rats2) belapectin was associated with decreased:  Galectin-3 staining and galectin-3 expression in macrophages  NAFLD Activity Scores  Collagen-1 expression  Hepatic collagen deposition  Hepatic fibrosis   Portal pressure  In toxicology studies, including monkeys, belapectin:  Was well-tolerated even at high doses  Accumulated in macrophages with a residence time longer than in plasma  1. Traber PG, et al. PLoS One. 2013;8(12):e83481. 2. Traber PG, et al. PLoS One. 2013; ;8(10):e75361.  6  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 
 

 Unmet Need & Patient Landscape  Naga Chalasani, M.D. 
 

 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% of the global population is estimated to be affected by MASH, though the disease is considered to be underdiagnosed2  There are genetic predisposition to MASH, yet certain health conditions put patients at increased risk:3   1. Fatty Liver Foundation. https://www.fattyliverfoundation.org/#gsc.tab=0. .2. Sherif ZA, et al. Dig Dis Sci. 2016;61(5):1214-25. 3. NIDDK. NAFLD and MASH. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/symptoms-causes. 4. Datamonitor Healthcare. MASH Disease Analysis. 5. Scientific Registry of Transplant Recipients. OPTN/SRTR 2021 Annual Data Report: Liver. https://srtr.transplant.hrsa.gov/annual_reports/2021/Liver.aspx. 6. Stepanova M, et al. Hepatol Commun. 2022;6(7):1506-1515. 7. Zobair M. Younossi, et al, Prevalence and predictors of cirrhosis and portal hypertension in the United States, American Association for the Study of Liver Disease, DOI: 10.1097/HEP.0000000000001243.  Being overweight or obese  Having hypertension, high cholesterol or high triglyceride levels  Having type 2 diabetes, insulin resistance or prediabetes  8  MASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment  30% of those listed for liver transplant will die waiting1  MASH cirrhosis is expected to become the most frequent reason for a liver transplant6  Prevalence increased >2x in the past decade 4  Addressable market in the U.S.  ~8.7K  Liver transplantations in the U.S.5   100M   Americans have fatty liver disease (most don’t know it)1  20M   Develop liver fibrosis1  5M   Progress to MASH cirrhosis1  3.3M  MASH cirrhosis and portal hypertension7  Only curative treatment is liver transplant1  ~8.7K  Liver transplantations in the U.S.5  
 

 HPVG=hepatic venous pressure gradient.   There are no approved therapies to reverse portal hypertension once it develops in MASH Cirrhosis  9  When to Intervene in Cirrhosis- before its too late!  Compensated cirrhosis  Decompensated cirrhosis  No Portal Hypertension   Portal Hypertension  No varices  No varices  Varices,   small to large  Varices Bleeding, ascites, encephalopathy  ≥10   One year mortality 1-3%  ≥6   One year mortality ~50% 
 

 Cirrhosis  Current Treatment Paradigm  Lifestyle Interventions ± co-morbidity management  NASHFibrosis Stage: 3/4   NASHFibrosis Stage: 1/2  NAFL/NASHFibrosis Stage: 0  Bariatric Surgery  Pharmacologic TherapyNon selective beta-blockers, statisn  Liver Transplantation  Non-Metabolic Disease Agents  Vitamin E  Pioglitazone  Metabolic Disease Agents  SGLT2 inhibitor   GLP-1RA Pemafibrate  Screening for Varices and HCC  Lifestyle interventions are used to promote weight-loss, a key component to improve the histopathologic feature of this disease  Pharmacologic therapy Non-selective beta blockers (NSBB) and statins to manage portal hypertension.  Non-Metabolic disease agents: vitamin E may be used in patients without diabetes, data is mixed with potential safety concerns (e.g., increase in mortality); Pioglitazone has been shown to reduce the incidence of NAFLD in T2D/obese patients and improve fibrosis  Metabolic disease agents may be prescribed to NASH patients with diabetes, depending on physician preference   Bariatric surgery is promising for patients who are unable to achieve sufficient weight loss at 6 months; histologic improvement has been observed post-operatively  Screening is recommended every 6 mos. for ≥3 fibrosis or for those with non-invasive markers highly suggestive of advanced fibrosis  Liver transplant is typically considered when patients have developed cirrhosis, complications (e.g., ascites), or a MELD score ≥15. Transplant is currently the only option for advanced cirrhotic patients  Treatment Progression  Disease Progression  Goal  Hepatic Lipid Reduction  Improved NASH  Regressed Fibrosis  Madrigal’s THR- agonist Rezdiffra approved for F2/3 population  Madrigal’s Rezdiffra recently approved for F2/3 patients; Limited late-stage options  Sources: 1. Up to Date; 2. Zhang et al 2021; 3. Paternostro et al 2022; 4. Chalasani et al 2017; 5. Chalasani et al 2018; 6. Canbay et al 2016  10 
 

 11  Belapectin is a Novel Therapy with First- and Best-in-Class Potential in MASH Cirrhosis  3rd Party Market Opportunity Assessment Suggests1  Potential 35-70% 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 safety by HCPs   Payers believe in the high unmet need in MASH cirrhosis  1. LifeSci Consulting Belapectin Commercial Opportunity Assessment contracted by the Company.   United States Estimates1  A significant unmet need exists for MASH compensated cirrhosis patients with portal hypertension due to disease severity and risk of decompensation  $18B  5M  1.7M  Patients with compensated MASH cirrhosis in 2024   Patients with compensated cirrhosis and portal hypertension with no varices in 2024   Peak belapectin sales in U.S.  
 

 Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial   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.  Subjects with no varices at baseline  p=0.02  p=0.44  Baseline   1 year  Baseline   1 year  Baseline   1 year  Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis1,*   No patients on 2 mg/kg/LBM developed new varices 
 

 Clinical Results – NAVIGATE Trial design & Results  Naim Alkhouri, M.D.  Naga Chalasani, M.D.  
 

 14  NAVIGATE Trial Design  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)  Trial Design  Patient Population  MASH cirrhosis based on Liver Forum Recommended Criteria for Clinical Trials1  Diagnosis of Portal Hypertension as per Baveno VI criteria (via non-invasive markers)  No gastroesophageal varices by endoscopy at baseline  Assessment of Varices thru central adjudication of endoscopy videos by multiple blinded reviewers based on standardized protocol. 
 

 15  NAVIGATE Study: Patient Population and Efficacy Endpoints  MASH cirrhosis  No varices on EGD  CTP Scores <7  Evidence of Portal hypertension:  Platelet count <150,000/mm3. Or at least two of the following  AST/ALT > 1  Spleen ≥ 14 cm  Collaterals by imaging  Stiffness ≥ 20 kPa  Composite primary end point in ITT population  Incidence of Varices in per protocol population (Completers)  Hepatic decompensation events  All-cause mortality  Proportion of patients with large varices or red wale sign  Varices requiring treatment  MELD ≥ 15   Liver transplant  ALT=alanine aminotransferase ; AST=aspartate transaminase; CTP=Child-Turcotte-Pugh; EGD=Esophagogastroduodenoscopy; MELD=model for end-stage liver disease.  *Intercurrent events include; Liver related clinical events, any AE leading to discontinuation, TIPS Trans-jugular intrahepatic portosystemic shunt; ≥12-month use of GLP-1 or NSBB  ITT- Intent to Treat  Key inclusion criteria  Primary endpoint  Composite secondary endpoint 
 

 16  Key Populations for Assessment of Varices Outcome  ITT population- All randomized subjects minus two subjects who had varices at baseline;  Per- Protocol or completer population- All subjects who completed 18 month of therapy and had an EGD at baseline and 18 month  Subject were required to complete the study even after development of varices unless subject dropped out for other reasons  Composite Primary end point: Any subject who developed esophageal varices or had an intercurrent event or dropouts without an EGD/intercurrent event  Intercurrent events included;   Liver related clinical events,   AE leading to discontinuation  TIPS-Trans-jugular intrahepatic portosystemic shunt   ≥12-month use of GLP-1 or NSBB    
 

 NAVIGATE Trial: Baseline Demographics   (N=355)     Placebo (N = 118)  Belapectin 2 mg (N = 119)  Belapectin 4 mg (N = 118)     Mean (Standard Deviation)  Mean (Standard Deviation)  Mean (Standard Deviation)  Age (years)  60.4 (8.50)  60.6 (8.82)  59.0 (9.14)  Gender (female), n  72 (61.0)  75 (63.0)  83 (70.3)  Ethnicity (Hispanic), n  34 (28.8)  39 (32.8)  33 (28.0)  Race (white), n  104 (88.1)  107 (89.9)  111 (94.1)  BMI (Kg/m2)  33.82 (6.46)  34.88 (6.68)  34.53 (6.22)  Hypertension  89 (75.4)  89 (74.8)  82 (69.5)  Type 2 Diabetes  80 (67.8)  79 (66.4)  79 (66.9)  HbA1C %  6.4 (1.27)  6.3 (1.13)  6.4 (1.09)  Alanine Aminotransferase (ALT), U/L  46.3 (29.92)  38.9 (26.88)  39.7 (20.22)  Aspartate Aminotransferase (AST), U/L  46.7 (23.52)  41.8 (24.40)  43.6 (21.90)  Platelets (per µL)  130.1 (39.66)  127.6 (48.39)  136.4 (53.62)  Liver Stiffness Measurement (kPa)  24.22 (12.17)  24.63 (13.54)  25.67 (13.19)  Spleen (cm)  13.79 (2.7)  13.97 (2.6)  13.87 (2.4)  Child Pugh Score   5.1 (0.29)  5.1 (0.31)    5.0 (0.18)  Statins (n)  49 (41.5)  55 (46.2)  47 (39.8)  GLP-1 agonist (n)  24 (20.3)  26 (21.8)  27 (22.9)  17 
 

 NAVIGATE 18-Month Primary Analyses Result – ITT Population  Key points  Intent to Treat (ITT) -All randomized subjects  Primary end point composite strategy i.e. new varices and/or intercurrent events or drop out  Intercurrent events (ICEs) include; Liver related clinical events, AE leading to discontinuation, TIPS; ≥12-month use of GLP-1 or NSBB   Overall Target Significance level– 2-sided p value of 0.05; p: 0.048, using CMH test, stratified by Type 2 diabetes status at randomization.  p 0.139  p 0.552  n = 118   n = 119   n = 118   ITT Population  Number of subjects with new varices  Composite Primary Endpoint, ITT (All Randomized)  18 
 

 NAVIGATE: Significantly Lower Incidence of Varices in Completers at 18 month  N = 97  N = 98  N = 95  n = 94   n =97   n = 96   p=0.04  p=0.13  Number of subjects  Subjects with new varices  Key points  NAVIGATE 18-month Primary Analyses Result; Per protocol population n= 287  Completer/Per Protocol: All ITT subjects who completed 18 months of treatment with an end of treatment (EOT) EDG  Overall Target Significance level – 2-sided p value of 0.05; using CMH test, stratified by Type 2 diabetes status at randomization.  19 
 

 NAVIGATE: Improvement in LSM- Baseline to 18 months  Per-Protocol (Completers n: 269)  Liver Stiffness kPa mean change %   Placebo   (N=88)  2mg/kg LBM (N=94)  4mg/kg LBM (N=87)  Baseline LSM Value (kPA)            Mean (SD)  23.4 (11.46)  23.6 (13.19)  25.5 (11.84)   Median  22.4  21.5  23.4  18-month LSM Value (kPa)            Mean (SD)  22.7 (13.62)  20.7 (12.66)  22.4 (12.20)  Change from Baseline in LSM Value (kPa) @ 18 months            Mean (SD)  -0.7 (10.81)  -2.9 (11.50)  -3.1 (9.94)  % Change from Baseline @ 18 months LSM Value (kPa) *            Mean %  -3.1 (41.10)  -12.3 (38.73)  -12.1 (35.60)  Belapectin  20 
 

 21  Significantly Fewer Subjects Showed Worsening in Liver Stiffness Measure - LSM (kPa)  Increase in LSM of >30% or >10 kpa from baseline; Per-Protocol (n = 269)  p 0.03  p 0.02 
 

 22  Safety Summary  Discontinuation of the study due to Adverse Events was similar across 3 cohorts:  7 (5.9%) in the Pbo  5 (4.2%) in 2 mg/kg Belapectin  8 (6.7%) in 4 mg/kg Belapectin  One subject in each of the three cohorts discontinued the study due to death  No drug related SAE reported in the entire trial  No Adjudicated Drug-Induced Liver Injury (DILI) Events.  Adverse Events  Treatment-Emergent Adverse Events (TEAEs)  Treatment-Emergent Serious Adverse Events (TESAEs)  Similar proportion of subjects reported Treatment-Emergent Adverse Events TEAEs across 3 cohorts:  112 (94.9%) in Pbo  116 (97.5%) in 2 mg/kg Belapectin   116 (96.7%) in 4 mg/kg Belapectin  Similar proportion of subjects reported Treatment-Emergent Serious Adverse Events (TESAEs) across 3 cohorts:  23 (19.5%) in Pbo  27 (22.7%) in 2 mg/kg Belapectin   25 (20.8%) in 4 mg/kg Belapectin 
 

 23  Incidence of New Varices was Significantly Lower in Patients in the U.S.   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 
 

 Use of GLP-1 and Statin was Higher in Patients in the U.S.  24        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%)  11 (5.9%)  Concomitant Use of Statins n (%)  34 (54.8%)  31 (51.7%)  26 (40.6%)  93 (48.9%)  Concomitant Use of ACE Inhibitors n (%)  15 (23.8%)  17 (28.3%)  18 (27.7%)  50 (26.6%)  EX-U.S.     (N=32)  (N=37)  (N=32)  (N=101)  Concomitant Use of GLP-1 n (%)  5 (15.6%)  8 (21.6%)  12 (37.5%)  25 (24.5%)  Concomitant Use of NSBBs n (%)  2 (6.3%)  2 (5.4%)  3 (9.4%)  7 (6.9%)  Concomitant Use of Statins n (%)  8 (25.0%)  14 (37.8%)  16 (50%)  38 (37.6%)  Concomitant Use of ACE Inhibitors n (%)  4 (12.5%)  12 (32.4%)  11 (34.4%)  28 (27.5%)  Concomitant medication Use U.S. vs Ex- U.S.- Per Protocol  24 
 

 Key Takeaways   Belapectin 2 mg/kg significantly reduced the incidence of new esophageal varices at 18 months in patients with MASH cirrhosis and portal hypertension  Categorical changes in LSM mirror the higher incidence of new varices in the placebo compared to the 2 mg cohort.  These findings validate prior favorable observations from the GT-026 trial.  Favorable safety profile with adverse events, serious adverse events, and discontinuation rates comparable to placebo.  Belapectin has the potential to address the critical unmet need of patients with MASH cirrhosis and portal hypertension  25  01  02  03  04  05 
 

 Thank you!