GALECTIN THERAPEUTICS INC. Galectin Therapeutics Corporate Overview
April 2024
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 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 2022 and beyond. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, our trials and supporting CMC information may be impacted by COVID-19.
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, 2022, 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.
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Investment Highlights
Developing galectin-based therapeutics to improve the lives of patients with chronic liver diseases and cancer
Focused Pipeline
NASH Cirrhosis
Oncology (Combination Therapy)
Finance
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 NASH 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)
$20.4M* cash as of September 30, 2023 and $30M remaining under line of credit provided by GALT Chairman
Cash runway expected through 2024
*As of September 30, 2023. | 3 |
Highly Experienced Leadership Team
JOEL LEWIS
Chief Executive Officer &
President
POL F. BOUDES, M.D. | Over 25 years experience in drug development | |
in a variety of therapeutic areas including NASH | ||
Chief Medical Officer | and early-stage oncology, contributing to | |
multiple drug approvals in the U.S. and globally. | ||
Financial executive with over 25 years of management experience in a taxation, restructuring, acquisition, and private equity ventures.
Khurram Jamil, M.D.
VP, Clinical Development
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.
JACK W. CALLICUTT
Chief Financial Officer
SUE THORNTON
VP Regulatory Affairs
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.
More than 20 years of domestic and international drug development experience encompassing all aspects of global Regulatory Affairs and Quality Assurance.
JESSICA KOPACZEWSKI
Senior Director, Clinical Operations
SETH ZUCKERMAN
Senior Director,
Biostatistics
Over 25 years diverse experience in the pharmaceutical research industry supporting global study operations from site to personnel management.
Over 28 years of experience working in the pharmaceutical industry in clinical data and trial management with 23 years as statistician.
JEFF KATSTRA | Highly experienced in pharmaceutical | |
VP, CMC / Pharmaceutical | development of novel formulations and | |
medicines with advanced manufacturing | ||
Development | ||
techniques and bringing them to approval. | ||
EZRA LOWE, Ph.D.
VP, Clinical and Preclinical Pharmacology
Extensive experience in clinical pharmacology, drug metabolism, and pharmacokinetics with various drug formats and across therapeutic areas, leading to 10 different global drug approvals.
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Laser-Focused Pipeline
Clinical Program
Drug
Indication
Development Stage
Discovery | Preclinical |
Phase 1
Phase 2
Phase 3
Fibrosis
Belapectin
NASH 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
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Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases1,2
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
Galectin-3 drives many pathophysiological process in
fibrotic diseases and cancer Inflammation
Migration | Apoptosis |
Proliferation | Galectin-3 | Adhesion |
Differentiation | Angiogenesis |
Tumor Growth | Fibrosis | Metastasis |
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. | 6 |
Belapectin: a Proprietary Galectin-3 Inhibitor with Low Toxicity and Anti-fibrotic Activity
Belapectin Preclinical Data:
In animal models of NASH (streptozotocin High-Fat Diet mice1) and cirrhosis (thioacetamide treated rats2) belapectin was associated with decreased:
- Galectin-3staining and galectin-3 expression in macrophages
- NAFLD Activity Scores
- Collagen-1expression
- 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
Belapectin is a polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars
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1. Traber PG, et al. PLoS One. 2013;8(12):e83481. 2. Traber PG, et al. PLoS One. 2013; ;8(10):e75361.
NASH Cirrhosis
NASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No FDA-Approved Treatment
Non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), is characterized by fat accumulation, inflammation and fibrosis of the liver1
Addressable market in the U.S.
100M
Americans have fatty liver disease (most don't know it)1
3%-5% of the global population is estimated to be affected by NASH, though the disease is considered to be underdiagnosed2
There are genetic predisposition to NASH, yet certain health conditions put patients at increased risk:3
20M | Prevalence increased >2x |
Develop liver fibrosis1 | in the past decade 4 |
5M
Progress to NASH cirrhosis1
- Being overweight or obese
- Having hypertension, high cholesterol or high triglyceride levels
- Having type 2 diabetes, insulin resistance or prediabetes
Only curative treatment is
liver transplant1
~8.7K
Liver transplantations
in the U.S.5
30% of those listed for liver transplant will die waiting1
NASH cirrhosis is expected to become the most frequent reason for a liver transplant6
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 NASH. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/symptoms-causes. 4. Datamonitor Healthcare. NASH 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. | 9 |
Intervention Before Escalation: When to Intervene in Cirrhosis
Compensated | Decompensated | ||||
Cirrhosis | Cirrhosis | ||||
Liver Function | Despite histological findings, | timing | Liver is | ||
liver still able to function | treatment | irreversibly failing | |||
Symptoms | Usually no or minimal symptoms | Esophageal Varices (first | Varices Bleeding, ascites, | ||
clinical expression of PH) | encephalopathy | ||||
Ideal | |||||
No Portal Hypertension | Portal Hypertension | Portal Hypertension | |||
Portal hypertension (PH) | HPVG < 6 mm Hg | 6mm Hg < HPVG | HPVG > 10 mmHg | ||
≤ 10 mmHg | |||||
Mortality | One year mortality 1-3% | One year |
mortality ~50% | ||
There are no specific therapies available for patients with portal hypertension who have not yet developed varices
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HPVG=hepatic venous pressure gradient.
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Galectin Therapeutics Inc. published this content on 17 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 April 2024 07:59:03 UTC.
