# EDGAR Filing Document

**Accession Number:** 0001133416
**File Stem:** 0001140361-25-034242
**Filing Date:** 2025-9
**Character Count:** 37378
**Document Hash:** 0667bc9a39b8b78a6f6458d2598d79a0
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001140361-25-034242.hdr.sgml**: 20250908

**ACCESSION NUMBER**: 0001140361-25-034242

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 53

**CONFORMED PERIOD OF REPORT**: 20250908

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250908

**DATE AS OF CHANGE**: 20250908

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** GALECTIN THERAPEUTICS INC
- **CENTRAL INDEX KEY:** 0001133416
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 043562325
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-31791
- **FILM NUMBER:** 251298601

**BUSINESS ADDRESS:**
- **STREET 1:** 4960 PEACHTREE INDUSTRIAL BOULEVARD
- **STREET 2:** SUITE 240
- **CITY:** NORCROSS
- **STATE:** GA
- **ZIP:** 30071
- **BUSINESS PHONE:** 678-620-3186

**MAIL ADDRESS:**
- **STREET 1:** 4960 PEACHTREE INDUSTRIAL BOULEVARD
- **STREET 2:** SUITE 240
- **CITY:** NORCROSS
- **STATE:** GA
- **ZIP:** 30071

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** PRO PHARMACEUTICALS INC
- **DATE OF NAME CHANGE:** 20010612

?xml version='1.0' encoding='ASCII'?

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

#### PURSUANT TO SECTION 13 OR 15(d) OF THE

#### SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): **September 8, 2025**

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

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| | | |
|:---|:---|:---|
| **Nevada** | **001-31791**<br>| **04-3562325**<br>|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |

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#### 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)

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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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol** | **Name of each exchange on which**<br> **registered** |
| Common Stock $0.001par value per share | GALT | The Nasdaq Stock Market<br>|

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

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On September 8, 2025, Galectin Therapeutics Inc. (the "Company") posted to its website an updated Corporate Presentation attached hereto as Exhibit 99.1. A copy of the presentation is furnished herewith as Exhibit 99.1 and incorporated herein by reference.

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.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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(d) Exhibits.

<u> Exhibit No. </u> <u> Exhibit Description </u> <br> [99.1](ef20055150_ex99-1.htm) Galectin Therapeutic Inc. Corporate Presentation, updated September 8, 2025 <br> 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.

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| | | |
|:---|:---|:---|
|  | Galectin Therapeutics Inc. | Galectin Therapeutics Inc. |
| Date: September 8, 2025 | By: | /s/ Jack W. Callicutt |
|  |  | Jack W. Callicutt |
|  |  | Chief Financial Officer |

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## Exhibit 99.1

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**Exhibit 99.1**<br>

**** 

<br> **![](ef20055150_ex99-1slide41.jpg)

Galectin TherapeuticsCorporate OverviewSeptember 2025

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![](ef20055150_ex99-1slide42.jpg)

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," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements.These statements include those regarding potential therapeutic benefits of our drugs, expectations, plans and timelines related to our clinical trials, supporting activities, potential partnering opportunities and estimated spending for 2025 and beyond. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not product positive data.Future phases or future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Strategies and spending projections may change. We may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to complete our clinical trials or further develop and/or fund any future studies or trials.To date, we have incurred operating losses since our inception, and our future success may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2024, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements. Forward-Looking Statements

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![](ef20055150_ex99-1slide43.jpg)

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 efficacy observed in cirrhotic patients without varices Promising NAVIGATE results at 18 month read out, ≥40% reduction in new varices vs placebo in ITT; significantly lower incidence of new varices in per protocol population Encouraging clinical response in difficult-to-treat cancers in combination with checkpoint inhibitor IND filed and approval to proceed received from FDA (Head & Neck cancer) Developing galectin-based therapeutics to improve the lives of patients with chronic liver diseases and cancer Focused Pipeline MASH Cirrhosis Oncology (Combination Therapy) Investment Highlights 3

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![](ef20055150_ex99-1slide44.jpg)

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 industry in clinical data and trial management with 23 years as statistician. SETH ZUCKERMANSenior Director, Biostatistics Over 25 years diverse experience in the pharmaceutical research industry supporting global study operations from site to personnel management. JESSICA KOPACZEWSKI Senior Director, Clinical Operations Highly experienced in pharmaceutical development of novel formulations and medicines with advanced manufacturing techniques and bringing them to approval. JEFF KATSTRA VP, CMC / Pharmaceutical Development Extensive experience in clinical pharmacology, drug metabolism, and pharmacokinetics with various drug formats and across therapeutic areas, leading to 10 different global drug approvals. EZRA LOWE, Ph.D. VP, Clinical and Preclinical Pharmacology Financial executive with over 25 years of management experience in a taxation, restructuring, acquisition, and private equity ventures. JOEL LEWIS Chief Executive Officer & President Have two decades of expereince leading drug development across various stages of clinical trials in the pharmaceutical industry. Led multiple new drug application filings and secured approvals from several regulatory agencies. KHURRAM JAMIL, M.D.Chief Medical Officer

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![](ef20055150_ex99-1slide5.jpg)

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 identify subcutaneous forms of carbohydrates and oral small molecules 5 Laser-Focused Pipeline

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![](ef20055150_ex99-1slide6.jpg)

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 inflammation by activating proinflammatory pathways 1. Marino KV, et al. Nat Rev Drug Discov. 2023;22(4):295-316. 2. Henderson NC, et al. Proc Natl Acad Sci U S A. 2006;103(13):5060-5. Galectin-3 drives many pathophysiological process in fibrotic diseases and cancer 6 Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases1,2 Proliferation Inflammation Fibrosis Apoptosis Adhesion Angiogenesis Metastasis Tumor Growth Differentiation Migration Galectin-3

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![](ef20055150_ex99-1slide7.jpg)

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 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. 7

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![](ef20055150_ex99-1slide8.jpg)

MASH Cirrhosis

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![](ef20055150_ex99-1slide9.jpg)

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% 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. 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. Being overweight or obese Having hypertension, high cholesterol or high triglyceride levels Having type 2 diabetes, insulin resistance or prediabetes 9 ~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

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![](ef20055150_ex99-1slide10.jpg)

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 safety by HCPs Payers believe in the high unmet need in MASH cirrhosis Belapectin is a Novel Therapy with First- and Best-in-Class Potential 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 Peak belapectin sales in U.S. Patients with compensated cirrhosis and portal hypertension with no varices in 2024

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![](ef20055150_ex99-1slide11.jpg)

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 and 4 No varices No varices Varices, small to large Varices Bleeding, ascites, encephalopathy HVPG1 mm Hg One year mortality 1-3% One year mortality ~50% ≥6 >10

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![](ef20055150_ex99-1slide52.jpg)

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 complications No varices/varices (50:50) Primary endpoint Portal pressure (HPVG) change from baseline to Week 54 Secondary endpoints at Week 54 Liver biopsy Varices (esophago-gastric endoscopy) Cirrhosis decompensation HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass. 1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45.

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![](ef20055150_ex99-1slide53.jpg)

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 Baseline 1 yr Baseline 1 yr Baseline p=0.02 p=0.44 ITT Population Subjects with no varices at baseline 1 yr Baseline Baseline 1 yr

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![](ef20055150_ex99-1slide54.jpg)

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 mass. \*Chi square 1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45. p=0.02 p=0.12

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![](ef20055150_ex99-1slide15.jpg)

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 15 Originally the NAVIGATE trial was designed as an adaptive Phase 2b/3 trial for 36-month duration. However, based on FDA feedback, the Company made the decision to analyze the stage 1 (18 month) as stand-alone clinical trial. LBM- Lean body mass; EGD=Esophagogastroduodenoscopy; 1- Noureddin M, et al. Gastroenterology 2020 8;159(2):422-427 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.

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![](ef20055150_ex99-1slide16.jpg)

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 Development of new varices (composite strategy) 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 Non-invasive biomarkers 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 Secondary endpoint 16

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![](ef20055150_ex99-1slide17.jpg)

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 months 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 17

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![](ef20055150_ex99-1slide18.jpg)

NAVIGATE Trial: Baseline Demographics© 2014 Galectin Therapeutics \| NASDAQ: GALT Baseline Demographics and Clinical Characteristics (N=355)&nbsp;&nbsp;&nbsp;&nbsp; Placebo (N = 118) Belapectin 2 mg (N = 119) Belapectin 4 mg (N = 118)&nbsp;&nbsp;&nbsp;&nbsp; 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) Weight (kg) 94.2 (21.68) 98.1 (24.30) 94.6 (20.95) 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) MELD Score 7.6 (1.65) 7.9 (2.46) 7.5 (1.55) Child Pugh Score 5.1 (0.29) 5.1 (0.31)&nbsp;&nbsp;&nbsp;&nbsp;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) 18

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![](ef20055150_ex99-1slide19.jpg)

Key points NAVIGATE 18-Month Primary Analyses Result – ITT Population 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) 19

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![](ef20055150_ex99-1slide20.jpg)

NAVIGATE: Intercurrent Events breakdown by category© 2014 Galectin Therapeutics \| NASDAQ: GALT n = 118 Subject % Intercurrent Event Category 20 Key points No subject met intercurrent event category for Trans-jugular intrahepatic portosystemic shunt(TIPS) or ≥12-month use of non-selective beta-blocker NSBB ITT Population 6.3% subjects received concomitant NSBB, none for ≥ 12 months

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![](ef20055150_ex99-1slide21.jpg)

NAVIGATE: Significantly Lower Incidence of Varices in Completers at 18 months© 2014 Galectin Therapeutics \| NASDAQ: GALT 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 21 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.

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![](ef20055150_ex99-1slide22.jpg)

NAVIGATE: Incidence of Varices by Size at 18-months© 2014 Galectin Therapeutics \| NASDAQ: GALT Number of subjects with new varices Subjects with new varices New varices at 18 months in Per Protocol Population 22 Key points Placebo Treatment Group: N = 94 2mg/kg Belapectin Treatment Group: N = 97 4mg/kg Belapectin Treatment Group: N = 96 Varices grade definition Large > 5 mm in diameter, occupying more than 1/3 of esophageal lumen Medium >5 mm in diameter, occupying less than 1/3 of esophageal lumen Small <5 mm in diameter, minimally elevated above esophageal mucosa. p=0.04

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![](ef20055150_ex99-1slide63.jpg)

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 23

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![](ef20055150_ex99-1slide24.jpg)

Use of GLP-1 and Statin was Higher in Patients in the U.S. 24&nbsp;&nbsp;&nbsp;&nbsp; Treatment Group&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Placebo Belapectin 2mg/kg LBM Belapectin 4mg/kg LBM Total U.S.&nbsp;&nbsp;&nbsp;&nbsp; (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.&nbsp;&nbsp;&nbsp;&nbsp; (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%)&nbsp;&nbsp;&nbsp;&nbsp; Concomitant medication Use U.S. vs Ex- U.S.- Per Protocol 24

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![](ef20055150_ex99-1slide25.jpg)

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, additional drug molecules do not enhance efficacy Higher doses may exceed the macrophage-specific uptake mechanisms, resulting in altered drug distribution and clearance Higher drug concentrations have been associated with reduced efficacy, as observed in the GT-026 cohort, where subjects receiving 8 mg/kg (with higher AUC) exhibited lower pharmacodynamic (PD) effects. Similar PK profile shown by monoclonal antibodies and interferon among other agents. 2 mg/kg dose demonstrated consistent and most optimum efficacy response Similar PK-PD effects were observed across the GT-026 trial and the NAVIGATE 18-month results 25 Chalasani et al. Gastroenterology 2020; 158: 1334-1345 Pharmacokinetic-Pharmacodynamic (PK-PD)

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![](ef20055150_ex99-1slide26.jpg)

NAVIGATE: Improvement in LSM - Baseline to 18 monthsFull Analysis Set-FAS© 2014 Galectin Therapeutics \| NASDAQ: GALT ITT Population (n: 315) 26 N=97 N=96 Liver Stiffness kPa mean change % Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (N=102) (N=107) (N=106) Baseline LSM Value (kPA)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean (SD) 23.6 (11.44) 25.1 (15.04) 25.8 (12.91) Median 22.5 21.8 23.6 18-month LSM Value (kPa)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean (SD) 22.7 (13.71) 21.1 (12.88) 22.9 (13.40) Change from Baseline in LSM Value (kPa) @ 18 months&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean (SD) -0.6 (11.38) -2.9 (11.61) -2.2 (10.54) % Change from Baseline @ 18 months LSM Value (kPa) \*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean % 1.8 (47.26) -6.3 (39.13) -4.5 (37.30) \* Calculated percentage change for each subject

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NAVIGATE: Improvement in LSM - Baseline to 18 monthsPer-Protocol– Subjects with all available valid LSM© 2014 Galectin Therapeutics \| NASDAQ: GALT Per-Protocol (Completers n: 234) 27 N=97 N=96 Liver Stiffness kPa mean change % Belapectin Placebo 2mg/kg LBM 4mg/kg LBM (N=76) (N=81) (N=77) Baseline LSM Value (kPA)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean (SD) 22.6 (10.31) 24.6 (13.71) 25.7 (12.26) Median 22.4 21.8 23.4 18-month LSM Value (kPa)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean (SD) 21.9 (12.54) 21.4 (13.32) 23.4 (13.85) Change from Baseline in LSM Value (kPa) @ 18 months&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean (SD) -0.7 (10.71) -3.2 (12.05) -2.4 (10.90) % Change from Baseline @ 18 months LSM Value (kPa) \*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mean % 1.7 (46.78) -8.4 (38.33) -5.0 (38.05) \* Calculated percentage change for each subject

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28 Fewer Subjects Showed Worsening in Liver Stiffness Measure - LSM (kPa) Per-Protocol – Subjects with all available valid LSM Statistics based on Cochran-Mantel-Haenszel test; differences for placebo vs 4 mg not significant. NASDAQ: GALT Increase in LSM of >30% or >5 kpa from baseline; Per-Protocol (n = 234) Gawrieh S. et al. JHep 2024:81.600-608 p 0.09 p 0.03

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Key points Fewer Subjects Progressed to High-Risk ELF Category (ELF ≥13)Per-Protocol (n=280)© 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 Baseline to 18 months Per-Protocol (n=280) Belapectin Baseline ELF Value Placebo 2mg/kg LBM 4mg/kg LBM&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; N 89 96 95 Mean 10.67 10.54 10.59 SD 1.155 0.965 1.039 Number of subjects ELF score Category @ 18 month 29 Enhanced liver fibrosis (ELF) score predicts hepatic decompensation and mortality. Pearson M, et al JHEP Rep. 2024 Mar 11;6(6):101062.

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30 Incidence of Varices at 18 Months by Baseline ELF Categories© 2014 Galectin Therapeutics \| NASDAQ: GALT Per protocol population (n = 279) N = 30 N = 25 N = 25 n = 3/18 n = 3/19 n = 3/17 n = 1/21 n = 3/19 n = 9/50 n = 5/53 n = 6/53 n = 9/21 n = 5/22 n = 4/23

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Subjects Clinical Outcomes or MACE at 18 months© 2014 Galectin Therapeutics \| NASDAQ: GALT Per Protocol population&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Belapectin Placebo (N = 95) n (%) 2mg/kg LBM (N = 97) n (%) 4mg/kg LBM (N = 98) n (%) Subjects with Composite Clinical Outcomes, n (%) 4 (4.2) 3 (3.1) 7 (7.1) Varices (Esophageal or Gastric) Requiring Treatment 3 (3.2) 3 (3.1) 3 (3.1) Variceal Bleed Requiring Hospitalization 0 0 0 Clinically Significant Ascites Requiring Hospitalization 0 0 0 Spontaneous Bacterial Peritonitis 0 0 0 Overt Hepatic Encephalopathy (West Haven Score ≥2 and Requiring Hospitalization) 0 0 1 (1.0) Liver Transplant 0 0 0 Model End Stage Liver Disease (MELD) Score ≥ 15 0 0 1 (1.0) MI or Hospitalization for Unstable Angina 0 0 1 (1.0) Stroke or Transient Ischemic Attack 1 (1.1) 0 1 (1.0) MACE- major adverse cardiovascular events 31

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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. 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 Adverse Events Treatment-Emergent Adverse Events (TEAEs) Treatment-Emergent Serious Adverse Events (TESAEs) 32

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Assessment of Results 33 Belapectin 2 mg reduced varices incidence by 43.2% compared to placebo in the overall population(ITT); results were not statistically significant. In the per-protocol population/completer (18-month treatment + end-of-treatment EGD), the reduction was 48.9%. Initial sample size assumed 52.5% lower varices incidence with Belapectin vs. placebo. Per-protocol population definition (18-month treatment + EGD) parallels completer biopsy definition in MASH trials. U.S. enrolled patient results suggest synergistic benefit with GLP-1 therapy, highlighting Belapectin's potential as both monotherapy and in combination regimens. Less worsening in key markers of liver fibrosis marker provide further confidence in reduction in varices endpoint Belapectin maintained a clean safety profile with low discontinuation rates and no drug-related serious adverse events. Likely reasons for not achieving statistical significance in ITT; Fewer recorded varices than expected; mid-study sample size re-estimation based on composite endpoint, not varices. Shorter treatment duration; primary analysis at 18 months instead of 36 months. Higher dropout rate (18.3% observed vs. 10% expected), mostly during COVID and first 4 months.

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Key Takeaways and Next Steps 34 NAVIGATE enrolled the most advanced patients of recent MASH trials, requiring both MASH cirrhosis and portal hypertension. A robust reduction in new varices was observed in both ITT and completer populations after 18 months of treatment. Non-invasive biomarkers results, including LSM and ELF, aligned with clinical outcomes and provide pharmacodynamic proof of effect. The 2 mg dose of Belapectin has demonstrated consistent, clinically meaningful effects across multiple trials\*. The unique mechanism of Galectin-3 inhibition positions Belapectin as a differentiated and complementary candidate for MASH cirrhosis therapy. FDA feedback on NAVIGATE results planned by the year-end. Partnership opportunities are being actively pursued. \*Chalasani N, et al. Gastroentrol. 2020;158:1334-45

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Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)

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36 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 Cancer. 2024;12(10):e009952. Number of patients with or without progressive disease in hi/lo Galectin-3 expression in metastatic melanoma number of patients p=0.3 progression free Time to progression

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Increased progression-free survival in patients with higher trough level of pembrolizum1,\* 37 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 belapectin and pembrolizumab correlated with better clinical outcome including progression free survival in patients with MM and HNSCC \*Patients were grouped based on the trough levels of pembrolizumab at day 43: Q1Q2 (below population mean) and Q3Q4 (above population mean). \*\*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. Curti B. J Immunother Cancer. 2021;9:e002371.

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Phase 1 (Investigator-Initiated) of belapectin + pembrolizumab (Keytruda®) Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 11 38 Objective response observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients Extension in more advanced patients showed stable disease in 56% MM (5/9) and 40% in HNSCC (2/5) Combination treatment was well tolerated with no dose-limiting toxicity observed Fewer immune adverse events than expected Increased baseline expression of Gal3+ tumor cells, periphery PD-1+CD8+ T cells and reduced clearance of pembrolizumab correlated with clinical response IND filed and approval to proceed received from FDA (Head and Neck cancer) HNSCC=head and neck squamous cell carcinoma; MM=metastatic melanoma. 1. Curti B. J Immunother Cancer. 2021;9:e002371. Objective response to belapectin+pembrolizumab therapy at Day 85

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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 efficacy observed in cirrhotic patients without varices Promising NAVIGATE results at 18 month read out, ≥40% reduction in new varices vs placebo in ITT; significantly lower incidence of new varices in per protocol population Encouraging clinical response in difficult-to-treat cancers in combination with checkpoint inhibitor IND filed and approval to proceed received from FDA (Head & Neck cancer) Developing galectin-based therapeutics to improve the lives of patients with chronic liver diseases and cancer Focused Pipeline MASH Cirrhosis Oncology (Combination Therapy) Investment Highlights 39

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Thank you!

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