Galectin Therapeutics 8K This presentation contains, in addition to historical information, forward-looking statements | GALT 9 Jan 12

Company Overview

January 2012

OTC: GALT

Exhibit 99.1

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 which could cause actual results to differ

materially from those described in the statements. Factors that could cause our actual

performance to differ materially from those discussed in the forward-looking statements

include, among others: incurrence of operating losses since our inception, uncertainty as to

adequate financing of our operations, extensive and costly regulatory oversight that could

restrict or prevent product commercialization, inability to achieve commercial product

acceptance, inability to protect our intellectual property, dependence on strategic

partnerships, product competition, and others stated in risk factors contained in our SEC

filings. We cannot assure that we have identified all risks or that others may emerge which

we do not anticipate. 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.

2012 Galectin Therapeutics

OTC:GALT

Galectin Therapeutics Highlights

•

Leader in galectin science

•

Pipeline of carbohydrate-based drug compounds that inhibit

galectins

•

Focus on proven galectin activity in fibrosis and cancer

•

Liver Fibrosis

•

Target validated in convincing pre-clinical data

•

Two indications: NASH and Post-transplantation fibrosis

•

Clinical trials expected to begin in end of 2012

•

Cancer Therapy

•

Galectin inhibitor added to chemotherapy

•

Enhancement of immune function activates patient’s own immune

system to kill tumor cells

•

Clinical trial to begin January 2012

2012 Galectin Therapeutics

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2012 Galectin Therapeutics

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Galectin Proteins Are Normal Cell Proteins

That Promote Interactions Between

Glycoproteins

Galectin Proteins Are Important In

Disease Pathogenesis

2012 Galectin Therapeutics

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Secreted

Galectin

Proteins

PROMOTE

PATHOLOGY

Markedly Increased in:

Fibrosis

Cancer

Inflammation

Bind to cell

surface and matrix

glycoproteins

Modulate cell

signaling

Promote cell-cell

interactions

Promote cell-

matrix interactions

(galactose residues)

Galectin

Proteins

Galectin

Inhibitor

Our Galectin Inhibitors Are Novel

Carbohydrate-Based Drug Compounds

2012 Galectin Therapeutics

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•

Target secreted galectins and those

associated with cell membrane

•

Strong binding to multiple galectin proteins

and multiple galectins per drug molecule

•

High molecular weight allows long exposure to

galectin containing compartment

•

Low toxicity potential as a carbohydrate

with no toxic metabolites

•

Low manufacturing costs

•

Strong patent protection with no licensing

encumbrance

•

Two major classes of compounds under

development: GM-CT and GR-MD

Galectins Are Involved In The

Pathogenesis Of Many Diseases

•

Fibrosis of organs

•

Nearly all cancers

•

Heart failure

•

Ischemic cardiovascular and cerebrovascular disease

•

Arthritis

•

Allergic disease

•

Eczema and skin inflammation

•

Inflammatory bowel disease

•

Eye inflammation

•

Inflammatory and autoimmune disorders

•

Response to infections

•

Kidney disease

2012 Galectin Therapeutics

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Galectins implicated in:

Disease Area Development Programs

Cancer

Fibrosis

Liver Fibrosis

Immunotherapy

Chemotherapy

GALECTINS

2012 Galectin Therapeutics

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Disease Area Development Programs

Cancer

Fibrosis

Liver Fibrosis

Immunotherapy

Chemotherapy

GALECTINS

2012 Galectin Therapeutics

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Healthy

Cirrhosis

2012 Galectin Therapeutics

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Hepatitis C (57%)

Alcoholic liver disease (24%)

Non-alcoholic fatty liver (9.1%)

Hepatitis B (4.4%)

Miscellaneous (5.5%)

Source: Burden of liver disease in the United States: Summary of a

workshop. American Association for the Study of Liver Disease, May 2001

Multiple Diseases Lead To Liver Fibrosis And

Cirrhosis With Serious Medical Consequences

Liver Cirrhosis Is A Major Problem In

The United States

Transplants

(6,291*)

Wait List

(17,000**)

Death

(44,677

)

Cirrhosis

(400,000

)

Millions of people with liver disease that may progress to cirrhosis

* Performed in US in 2010 (UNOS)

* * Prevalence in US 2010 (UNOS)

The ONLY current therapy is liver transplantation

2012 Galectin Therapeutics

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Deaths in 1998 (AASLD Workshop, 2001)

Prevalence in US 1976-1980 (NIDDK)

Galectin-3 Is A Critical Target For

Therapy of Liver Fibrosis

Galectin-3 is produced in large amounts by human fibrotic liver.

Galectin-3 is essential in mice for the development of liver fibrosis.

Fibrosis due to toxin exposure or fatty liver does not occur in mice

that lack the galectin-3 gene.

Galectin inhibitors block production of fibrogenic markers in the key

human cell (stellate cells) responsible for liver fibrosis.

Galectin inhibitors reverse experimental fibrosis in rats induced by

both fibrosis and fatty liver.

2012 Galectin Therapeutics

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Key Evidence:

Galectin Inhibitors Effectively Treat

Toxin-Induced Liver Fibrosis in Rats

Liver Fibrosis, induced by injection

of chemical toxin for 8 weeks

Regression of Fibrosis after 4 weeks

of treatment with GR-MD-02

2012 Galectin Therapeutics

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Study performed under contract by Dr. Ji-yao Wang of Fudan University, Shanghai, China

GR-MD-02 is Most Effective in Reducing

Collagen Content in Fibrotic Rats

2012 Galectin Therapeutics

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% Collagen

Vehicle

GR-MD-01

GR-MD-02

N=8

One way ANOVA

Bondferroni

P<0.001

P<0.05

Mouse NASH Model (Non-Alcoholic

Steatohepatitis, “Fatty Liver Disease”)

2012 Galectin Therapeutics

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GM-CT-01

(120 mg/kg 2X/week)

GR-MD-02

(60 mg/kg 2X/week)

Early Rx

Late Rx

Early Rx

Late Rx

2012 Galectin Therapeutics

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GR-MD-02 Markedly Improves NASH in a Mouse Model When it is

Administered During Development of Disease and After

Establishment of Disease

Early Rx

Vehicle

GR-MD-02

Vehicle

GR-MD-02

Late Rx

In a Mouse NASH Model GR-MD-02 Prevents

and Completely Reverses Fibrosis

2012 Galectin Therapeutics

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normal

mouse 0.33

Early Rx

Late Rx

Development Program & Markets

•

Pursue two indications for human proof of concept

•

NASH

•

Post-Transplant Hepatitis C Fibrosis

•

NASH

•

NIH estimates 5% of US population has NASH

•

Projected to become the number one reason for liver transplant

•

Multiple candidates in development but none have multiple sites of action,

effect on fibrosis, or safety profile

•

Post-Transplant Hepatitis C Fibrosis

•

Much smaller population but high unmet medical need

•

Orphan disease status possible

•

Expansion to other indications is possible

•

Other liver diseases such as hepatitis and alcoholic disease

•

Pulmonary, renal, and heart fibrosis

2012 Galectin Therapeutics

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2012 Galectin Therapeutics

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2012

2013

2014

Phase II Post Tx Fibrosis Trial

Phase I DE

NASH

GR-MD-02

Design Phase II Trial

NASH

Fibrosis Development Program

Preclinical Efficacy Studies

GR-MD-02

First patient

enrolled

Pre-Clinical (Target SQ)

Oral Formulation

Development

Lung fibrosis: Bleomycin

and radiation

Kidney fibrosis: Ureteral

obstruction; diabetic

nephropathy

Heart fibrosis: Heart failure

and arrhythmia

First patient

enrolled

Top line

results

Top line results

Pursue

Partnering

Discussions

GR-MD-02

Post Transplant Fibrosis

Summary Of Development Program In

Liver Fibrosis

•

Liver fibrosis represents a very large unmet medical need

•

Galectin-3 protein is proven target

•

Drugs reverse liver fibrosis in animals and show efficacy

in human cell culture models of fibrosis

•

Non toxic drugs with little likelihood of drug interactions

•

Rapid clinical development pathways

•

Evaluation of two clinical indications

2012 Galectin Therapeutics

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Disease Area Development Programs

Cancer

Fibrosis

Liver

Fibrosis

Immunotherapy

GALECTINS

Chemotherapy

2012 Galectin Therapeutics

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Roles Of Secreted Galectins In Cancer

The vast majority of cancers secrete large amounts of galectins

•

Tumor cell invasion:

extracellular matrix

adhesion & detachment

•

Stromal cell function

•

Metastasis:

cell invasion and

migration

•

Angiogenesis

•

Tumor immunity

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Clinical Trial Performed In Metastatic

Colorectal Cancer (DAVFU-003)

Cancer Trial

(DAVFU-003)

Day 0

Day 28

GM-CT-01

Chemo (5-FU)

•

Phase 2 trial of 5-FU plus GM-CT-01 in line 3/4 therapy of metastatic colorectal

cancer

showed

6.7

months

median

survival.

similar

patients,

Erbitux

had

6.1 month survival compared to 4.6 months with no therapy

•

Notably, serious adverse events were markedly lower in our studies with 5-

FU/GM-CT-01 than in comparison to other studies using 5-FU

2012 Galectin Therapeutics

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Development Approach In

Colorectal Cancer

•

Studies demonstrate potential utility of galectin inhibitors in

combination with chemotherapy in cancer

•

FDA has confirmed that preclinical and clinical data are

adequate to proceed with large clinical trials

•

We are deferring new clinical trials pending data from the tumor

immunology clinical trial that may improve the design of future

studies

•

More rapid international registration is an approach that may

provide revenue to support development programs and gain

additional clinical experience with GM-CT-01

2012 Galectin Therapeutics

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Tumor-Specific

Cytotoxic T-Cell

Lymphocytes

Blocking Galectins Enhances Tumor

Killing By Immune System

2012 Galectin Therapeutics

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Tumor Cells

Cytotoxicity

There are tumor specific cytotoxic T-cells in

patients with cancer that are capable of killing

tumor cells

Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in

Brussels, Belgium as a collaboration with Galectin Therapeutics

Tumor-Specific

Cytotoxic

T-Cell

Lymphocytes

Blocking Galectins Enhances Tumor

Killing By Immune System

2012 Galectin Therapeutics

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Tumor

Cells

However, these T-cells lose the ability to kill

tumor cells. A key reason is that Galectin-3

secreted by tumors bind to T-cells and turn off

their ability to kill tumor cells

Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in

Brussels, Belgium as a collaboration with Galectin Therapeutics

Tumor-Specific

Cytotoxic T-Cell

Lymphocytes

Blocking Galectins Enhances Tumor

Killing By Immune System

2012 Galectin Therapeutics

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Tumor Cells

Cytotoxicity

Addition

our

drugs,

which

inhibit galectins,

Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in

Brussels, Belgium as a collaboration with Galectin Therapeutics

restore

the

ability

T-cells

kill tumor

cells

GM-CT-01 Restores Ability of Immune

Cells to Kill Tumor Cells

2012 Galectin Therapeutics

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Melanoma Clinical Trial Design (I)

2012 Galectin Therapeutics

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Phase I/II study of peptide vaccination associated with GM-CT-01,

a galactomannan oligomer that inhibits galectin-3, in patients with

advanced metastatic melanoma

IMPD approved by EMA

Tumor Immune Enhancement Development Program

2012 Galectin Therapeutics

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2012

2013

2014

Preclinical Efficacy Studies

GM-CT-01 & GR-MD-02

GM-CT-01

Phase I/II Melanoma Trial

Top line

results in

Stage 1

First patient

enrolled

Top line

results in

Stage 2

Human CD8 T-Cell/Tumor

assay

Efficacy in immune

competent mice with

syngeneic tumors

Efficacy in combination

with a tumor vaccine

(partnership)

Pursue

Partnering

Discussions

Development Program In Cancer

Immunotherapy

•

Galectin proteins secreted by tumor cells are directly

responsible for inhibiting the ability of immune cells to kill

tumors

•

GM-CT-01 restores the ability of immune cells to kill tumor cells

•

Initial clinical trial for treatment of metastatic malignant

melanoma

•

Market for tumor vaccines is expected to grow to $7B by 2015

•

Potential important therapy for many cancers

2012 Galectin Therapeutics

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Pipeline

2012 Galectin Therapeutics

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Pre-Clinical

Registration

Submitted

Chemotherapy

Colorectal Cancer:

GM-CT-01

•

International (Colombia)

•

United States

Immune Enhancer

Melanoma: GM-CT-01

Liver Fibrosis

Post Tx: GR-MD-02

NASH: GR-MD-02

Phase 1

Phase

Phase 2

Galectin Therapeutics Highlights

•

Leader in galectin science

•

Pipeline of carbohydrate-based drug compounds that inhibit

galectins

•

Focus on proven galectin activity in fibrosis and cancer

•

Liver Fibrosis

•

Target validated in convincing pre-clinical data

•

Two indications: NASH and Post-transplantation fibrosis

•

Clinical trials expected to begin in end of 2012

•

Cancer Therapy

•

Galectin inhibitor added to chemotherapy

•

Enhancement of immune function activates patient’s own immune

system to kill tumor cells

•

Clinical trial to begin January 2012

2012 Galectin Therapeutics

OTC:GALT

Galectin Therapeutics (GALT) 8-KThis presentation contains, in addition to historical information, forward-looking statements