Full Press Release Details
Galectin TherapeuticsCorporate OverviewAugust 2024
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 2024 and beyond. Factors that could cause our actual
performance to differ materially from those discussed in the forward-looking statements include, among others, that our trials and supporting CMC information may be impacted by a resurgence of COVID-19 or a similar outbreak of an infectious
disease.We may experience delays in our trials, which could include enrollment delays. 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, 2023, 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
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 2035 Only company to exclusively focus on treatment for the cirrhotic stage of MASH Significant efficacy observed
in cirrhotic patients without varices Ongoing adaptively-designed pivotal Phase 2b/3 trial; interim readout expected in Q4 2024 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 $23.6M* cash and $20M remaining under line of credit provided
by GALT Chairman* Cash runway expected through May 2025 *As of March 31, 2024. Focused Pipeline MASH Cirrhosis Oncology (Combination Therapy) Finance Investment Highlights 3
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 More than 20 years of domestic and international drug development experience encompassing all aspects of global Regulatory Affairs and Quality Assurance. SUE THORNTON VP Regulatory
Clinical Program Development
Stage Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis Belapectin MASH Cirrhosis 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
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
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
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. 5M Progress to MASH cirrhosis1 20M Develop liver fibrosis1 100M Americans have fatty liver disease (most don't know it)1 Only curative treatment is liver transplant1 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 Being
overweight or obese Having hypertension, high cholesterol or high triglyceride levels Having type 2 diabetes, insulin resistance or prediabetes 9
10 3rd Party Market Opportunity Assessment Suggests1 Potential 50-100%
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.
May 2024. United States Estimates1 A significant unmet need exists for MASH compensated cirrhosis patients with portal hypertension due to disease severity and risk of decompensation $8.8B 2.1M 331K 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
Compensated Cirrhosis Decompensated Cirrhosis Decompensated
Cirrhosis Liver Function Liver is irreversibly failing Liver is irreversibly failing Symptoms Usually no or minimal symptoms Esophageal Varices (first clinical expression of PH) Varices Bleeding, ascites, encephalopathy Varices
Bleeding, ascites, encephalopathy Portal hypertension (PH) No Portal Hypertension Portal Hypertension Portal Hypertension Stage 3 and 4 HPVG < 6 mm Hg 6mm Hg < HPVG 10 mmHg HPVG > 10 mmHg Mortality One year
mortality 1-3% One year mortality ~50% HPVG=hepatic venous pressure gradient. Ideal treatment timing There are no specific therapies available for patients with portal hypertension who have not yet developed varices Intervention Before
Escalation: When to Intervene in Cirrhosis Despite histological findings, liver still able to function 11
LBM=lean body mass.1. Chalasani N, et al. Gastroentrol 2020;158:1334-45. 2.
Curti B. J Immunother Cancer. 2021;9:e002371. Belapectin Demonstrated Efficacy and Safety in Clinical Trials1,2 12 Belapectin was well-tolerated and appeared safe in Phase 1 and Phase 2b clinical studies No adverse safety signal
identified Phase 2 study with one year of biweekly infusion: Completion rate was 94% Well-tolerated in doses up to 8 mg/kg LBM Belapectin exposure did not appear to increase with higher degree of hepatic insufficiency Encouraging data
from Phase 2 Study; Phase 2b/3 Adaptive Trial currently underway The Phase 2b MASH cirrhosis study provided a proof of concept for: Efficacy Choice of a relevant clinical outcome (prevention of varices) Dose range
selection Efficacy Safety
Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: Study
Design1 13 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.
Total Patient Population: Belapectin Impact on HPVG at One Year1,* 14 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
Patients without Varices: Belapectin Significantly Reduced HVPG at One
Year1,* 15 HVPG = Hepatic Venous Pressure Gradient; LBM=lean body mass. *ITT with LOCF, ANCOVA with baseline as covariate and treatment varices, and treatment/varices interaction as factors, LOCF, Bonferroni-Holm1. Chalasani N, et al.
Gastroentrol. 2020;158:1334-45. Statistically significant effect of 2 mg/kg/LBM dose on change in HVPG from baseline at 1 year p=0.02 p=0.44 Baseline 1 yr Baseline 1 yr Baseline 1 yr
Belapectin Reduces Emergence of Varices1,* 16 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
Next Step: NAVIGATE Belapectin's Seamless, Adaptive Study *Minimum number of
additional patients in Phase 3, sample size adjusted based on Interim Analysis results. Screen Randomize (1:1:1) Interim analysis to inform potential filling/Phase 3 Final analysis Placebo (minimum additional 70 patients*) Sample
size re-estimation Randomize (2:1) Belapectin 4 mg/kg/LBM Q2W n=119 Belapectin 2 mg/kg/LBM Q2W n=119 Placebo n=119 Belapectin 4 mg/kg/LBM Q2W (minimum additional 140 patients*) Phase 3 (18 months) Phase 2b (18 months) 17
NAVIGATE Study: Patient Population and Efficacy Endpoints 18 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 Hepatic decompensation
events All-cause mortality Proportion of patients with large varices or red wales 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. Key inclusion criteria Primary endpoint Secondary endpoint
NAVIGATE Update 19 No systematic liver biopsies required Pre-screening on
portal hypertension clinical criteria Central review of esophago-gastro-endoscopies Interim analysis phase 2b expected December 2024 130+ 15 5 sites countries continents Approximately Recruitment complete 357 patients
randomized in Phase 2b portion of trial
Cancer Immunotherapy Program (Belapectin + checkpoint inhibitor)
Phase 1 (Investigator-Initiated) of belapectin + pembrolizumab
(Keytruda ) Belapectin in Combination with Pembrolizumab Showed Clinical Efficacy and Safety in Phase 11 21 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
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 2035 Only company to exclusively focus on treatment for the cirrhotic stage of MASH Significant efficacy observed
in cirrhotic patients without varices Ongoing adaptively-designed pivotal Phase 2b/3 trial; interim readout expected in Q4 2024 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 $23.6M* cash and $20M remaining under line of credit provided
by GALT Chairman* Cash runway expected through May 2025 *As of March 31, 2024. Focused Pipeline MASH Cirrhosis Oncology (Combination Therapy) Finance Investment Highlights 22