Galectin Therapeutics 8K This presentation contains, in addition to historical information, forward-looking statements | GALT 5 Feb 13

Corporate Summary

February 5, 2013

NASDAQ: 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.

2013 Galectin Therapeutics

NASDAQ:GALT

Proprietary

Compounds

•

First in class, proprietary compounds that inhibit galectin proteins

•

Complex carbohydrate drugs with highly favorable safety profile

•

GM-CT-01: Enhanced ability of immune cells to kill of cancer cells

•

GR-MD-02: Potential to treat non-alcoholic steatohepatitis (NASH)

and other causes of liver fibrosis

Validated Science

•

Pre-clinical models show galectins are critical targets for intended

diseases with mechanisms that would be novel in the market

Large Market

Opportunities

•

Enhancing the ability of immune system to kill cancer cells is

synergistic with many current and experimental therapies

•

NASH and liver fibrosis indications would be first therapies for

completely unmet medical needs, representing a multi-billion

dollar market

Intellectual Property

•

Sole ownership, no licenses granted

•

GM-CT-01: Matter and methods granted (expire 2023)

•

GR-MD-02: Use in liver fibrosis (expire 2026); Matter pending

(priority of 2011)

Experienced

Management Team

•

Management team has collective experiencer in multiple biotech

and Pharmaceutical companies and relevant scientific areas

Investment Highlights

2013 Galectin Therapeutics

NASDAQ:GALT

Experienced Management Team

Peter G. Traber, MD

President, CEO, CMO

•

Over 25 years experience in biomedicine and pharmaceutical industries in research

and development, clinical medicine, management and leadership, and business

development. Medical expertise in liver disease

•

GlaxoSmithKline (CMO), Un of Pennsylvania (CEO), Baylor College of Medicine (CEO)

Harold H. Shlevin, PhD

COO

•

Over

years

senior

management

experience

the

development

and

commercialization of pharmaceuticals, diagnostics and vaccines

•

Solvay Pharmaceuticals (CEO), CIBA Vision Ophthalmics (co-founder), Tikvah

Therapeutics (Founder, CEO), Georgia Institute of Technology’s Advanced Technology

Development Center, Altea Therapeutics Corporation

Eliezer Zomer, PhD

EVP, Product

Development

•

Over

years

experience

biotechnology

engineering

and

regulatory

pharmaceuticals and

diagnostics.

•

Koor Biotechnologies, Charm Sciences, Glycogenesis, HU Medical School

(Jerusalem), Harvard University

Thomas A. McGauley

CFO (acting)

•

Over 10 years in accounting and finance with life science and technology companies

•

PricewaterhouseCoopers, Pro-Pharmaceuticals, deCode Genetics

Anatole Klyosov, PhD

Chief Scientist

•

Over 30 years’

experience in business and operations management for public and

private scientific, and biotech corporations and startup companies

•

eHealthDirect, Signatron, ArsDigita and Thermo Fibergen

J. Rex Horton

Executive Director,

Regulatory Affairs and

Quality Assurance

•

Over 20 years of experience working in the biotech and life sciences industries,

regulatory affairs and manufacturing.

•

Solvay Pharmaceuticals, Chelsea Therapeutics, Georgia Institute of Technology.

2013 Galectin Therapeutics

NASDAQ:GALT

•

Science of Galectins

•

Galectin Function

•

Galectin Inhibitors

•

Intellectual Property

•

Immune Enhancement in Cancer Therapy

•

Mechanism of Action

•

Regulatory and Clinical Plan

•

Competitive Positioning

•

Liver Fibrosis

•

Mechanism of Action

•

Regulatory and Clinical Plan

•

Competitive Positioning

•

Milestones

2013 Galectin Therapeutics

NASDAQ:GALT

Galectin Proteins Are Critical Participants In

Pathogenesis of Many Fibrotic and Neoplastic

Diseases

Bind to cell surface

and matrix

glycoproteins

(galactose residues)

•

GALECTINS

PROMOTE

PATHOLOGY

Markedly Increased in:

Inflammation

Fibrosis

Cancer

*Secreted in small amounts normally

by a number of cells, predominantly

macrophages

Galectin-3 is most

prominent galectin

secreted in disease

2013 Galectin Therapeutics

NASDAQ:GALT

Promote cell-

matrix interactions

Promote cell-cell

interactions

Modulate cell

signaling

Secreted

Galectin

Proteins*

Galectin

Proteins

Galectin

Inhibitor

Galectin Inhibitors: A New Class of

Pathology Modulators

•

Novel complex carbohydrate drugs that target

secreted and membrane-associated galectins by

virtue of high molecular weight

•

Strongest binding to galectin-3, most prominent

galectin in disease processes

•

Binding to galectins disrupts function and

modulates multiple

cellular pathways in

pathology representing a potential new class of

therapeutic agents

•

Low toxicity potential as a carbohydrate

with no toxic metabolites

•

Two classes of compounds under development

•

GM-CT

•

GR-MD

•

Low manufacturing costs; abundant natural

plant product starting materials

2013 Galectin Therapeutics

NASDAQ:GALT

Intellectual Property

•

GM-CT Class (current NCE is GM-CT-01)

•

US Composition of matter patent Issued 2011 (expires 2023)

•

Five US issued method of use patents in combination with cancer therapy for

increased efficacy and reduced side effects

•

International Patents: 14 granted and 5 pending

•

Method of use in liver fibrosis issued 2012 (expires 2026)

•

Method of use in NASH patent pending (priority 2011)

•

GR-MD Class (current NCE is GR-MD-02)

•

Method of use in liver fibrosis patent issued (expires 2026)

•

Composition of matter patent pending (priority 2011)

•

Method of use in NASH patent pending (priority 2011)

•

All intellectual property generated in house with no encumbrances

•

No established generic pathway for such complex carbohydrate drugs

2013 Galectin Therapeutics

NASDAQ:GALT

•

Science of Galectins

•

Galectin Function

•

Galectin Inhibitors

•

Intellectual Property

•

Immune Enhancement in Cancer Therapy

•

Mechanism of Action

•

Regulatory and Clinical Plan

•

Competitive Positioning

•

Liver Fibrosis

•

Mechanism of Action

•

Regulatory and Clinical Plan

•

Competitive Positioning

•

Milestones

2013 Galectin Therapeutics

NASDAQ:GALT

The Vast Majority of Cancers Secrete Large Amounts

of Galectins Which Have Multiple Roles in Tumor

Pathogenesis

•

Tumor cell invasion:

extracellular matrix

adhesion & detachment

•

Metastasis:

cell invasion and migration

•

Angiogenesis

•

Tumor immunity has

recently been shown to be

critically affected by

galectins

The “Galectin Effect”

protects tumors from

immune system

2013 Galectin Therapeutics

NASDAQ:GALT

Cytokines

Galectin-3

Cytokines

Kill tumor cells

GM-CT-01

Galectin-3 secreted by

tumor cells binds to surface

of T-cells and inhibits

cytokine secretion

Treatment with GM-CT-01

blocks Galectin-3 and

restores T-cell cytokine

secretion and tumor killing

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

Brussels, Belgium in collaboration with Galectin Therapeutics

Tumors Evade the Immune System Using the

“Galectin Effect”

and GM-CT-01 Reverses This Effect

2013 Galectin Therapeutics

NASDAQ:GALT

Tumor

Cells

T-Cells

Tumor

Cells

GM-CT-01

Has

Demonstrated

Safety

over

100

Human Subjects in Phase I and Partially Completed

Phase II Clinical Trials with Some Evidence of Efficacy

•

Phase I trial (DAVFU-001) in 40 subjects with end stage cancer showed GM-

CT-01 was safe alone and in combination with the chemotherapy 5-FU

•

Three Phase II trials were conducted, but only partially completed

•

One Phase II trial (DAVFU-001) of 5-FU plus GM-CT-01 in line 3/4 therapy

of metastatic colorectal cancer showed 6.7 months median survival. In

similar patients, Erbitux

®*

had a 6.1 month survival compared to 4.6 months

with no therapy

•

When

the

data

from

the

three

partially

completed

Phase

trials

were

pooled, the serious adverse events associated with 5-FU were reduced

when compared to historical controls

•

Our preclinical efficacy and clinical safety data were strong enough to obtain an

IMPD for Phase I/II trial in metastatic melanoma with a combination of a tumor

vaccine and GM-CT-01 to test the efficacy of blocking the “Galectin Effect”

[Study not being conducted under FDA IND, but there is open IND for GM-CT-01

*“Erbitux®

is a registered trademark of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company.“

2013 Galectin Therapeutics

NASDAQ:GALT

Preclinical efficacy and clinical safety data sufficient to

obtain an IMPD for treatment of metastatic melanoma to test

the efficacy of blocking the “Galectin Effect”

Melanoma “Proof of Concept”

Trial:

Patients:

Advanced metastatic melanoma

Design:

Two Stage (6 X 2 cohorts in stage 1 and 23 X 2

cohorts in stage 2)

Regimen:

Prime with melanoma specific peptide vaccine

Treat with GM-CT-01 to block “Galectin Effect”

Endpoint:

Partial or complete response by imaging

Group 2 patients have additional injection of GM-CT-01 in cutaneous tumors

2013 Galectin Therapeutics

NASDAQ:GALT

Tumor Immune Enhancement Development Program

2012

2013

2014

GM-CT-01

Phase I/II Melanoma Trial*

Pursue Partnering

Discussions

*Conducted in Belgium under an IMPD. Not conducted under FDA IND, but there is an open IND for GM-CT-01

At conclusion of Stage 1 of study:

•

2013 Galectin Therapeutics

NASDAQ:GALT

Stage 2 TBD

Top line

results in

Stage 1

Continue to Stage 2 with some

efficacy

Consider Phase IIb controlled trial

with strong efficacy

Seek partnership with company with

marketed or late stage cancer

immunotherapy

Stop for lack of efficacy

Immune Enhancement by Blocking “Galectin

Effect”

is Synergistic With Many Emerging

Cancer Immunotherapies

•

Enhancing

the

ability

the

immune

system

recognize

and

kill

tumor

cells is a very active area in the personalized approach to cancer therapy.

The “Galectin Effect”

inhibits the immune system

•

Two agents have been approved for use to date

•

Dendritic cell vaccine: Provenge®

(Dendreon)

•

T-cell activator (CTLA4 receptor mAb): Yervoy®

(Ipilimumab, BMS)

•

Many more vaccines and activators in development

•

Our drugs reverse the “Galectin Effect”

by which tumors inhibit the

immune system and may be synergistic

with all tumor immunotherapies.

•

While

tumor

vaccines

are

patient

and

tumor

specific,

reversal

the

“Galectin Effect”

appears to be universal. Initial Phase I/II clinical trial in

Belgium in combination with a vaccine to treat metastatic melanoma

•

The tumor vaccine market is forecast to be over $7 billion by 2015

2013 Galectin Therapeutics

NASDAQ:GALT

May be effective with unaltered immune system

Best Positioned to Advance Tumor

Immunotherapy with Galectin Inhibitor

•

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

ipilimumab (Yervoy ®, BMS) is included, market is even larger

•

Blocking the “Galectin Effect”

would be synergistic with all types of tumor

vaccines or immune stimulatory approaches

•

In this regard, competition will come from other galectin-inhibitors

•

Galecto Biotech AG (Sweden): Discovery phase focusing on small molecule inhibitors.

Development program focused on lung fibrosis.

•

LaJolla Pharmaceuticals (CA): In Jan. 2012, they purchased GCS-100 from Solana

Therapeutics (formally Prospect Therapeutics, formally Glycogenesis). GCS-100 is a

natural product compound with claims for binding galectins; focused on blood cancers;

significant side effects reported. Progressing in development for cancer and kidney

fibrosis.

•

Mandel Med (Oakland, CA): Truncated galectin-3 protein. Not progressed into human

trials and no active program currently.

•

Galectin Therapeutics is best positioned with a human trial in cancer

immunotherapy; GM-CT-01 has proved safe in Phase I and three partially

completed Phase II trials.

2013 Galectin Therapeutics

NASDAQ:GALT

•

Science of Galectins

•

Galectin Function

•

Galectin Inhibitors

•

Intellectual Property

•

Immune Enhancement in Cancer Therapy

•

Mechanism of Action

•

Regulatory and Clinical Plan

•

Competitive Positioning

•

Liver Fibrosis

•

Mechanism of Action

•

Regulatory and Clinical Plan

•

Competitive Positioning

•

Milestones

2013 Galectin Therapeutics

NASDAQ:GALT

NASH and Liver Fibrosis are Multi-

Billion Dollar Markets In US Alone

Transplants

(6,291*)

Wait List

(17,000**)

Death From Cirrhosis

(44,677

)

Cirrhosis

(400,000

)

NASH: 9-15 Million

* Performed in US in 2010 (UNOS)

* * Prevalence in US 2010 (UNOS)

Deaths in 1998 (AASLD Workshop, 2001)

Prevalence in US 1976-1980 (NIDDK)

Hepatitis C, Hepatitis B, Alcohol

Prevalence in US 2011 (NIH)

•

The ONLY current therapy for advanced fibrosis (cirrhosis) is liver transplantation

•

No approved medical therapy for fibrosis

•

While there are treatments for some underlying etiologies (Hepatitis C and B), there is

no approved therapy for NASH

2013 Galectin Therapeutics

NASDAQ:GALT

Galectin-3 Is A Critical Protein Target

For Therapy of Liver Fibrosis

Galectin-3 is produced in large amounts by fibrotic liver (animal and

human)

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

Fibrosis

due

toxin

exposure

fatty

liver

does

not

occur

mice that lack the galectin-3 gene

Galectin inhibitors reverse experimental fibrosis in rats induced by

both fibrosis and fatty liver

Key Evidence:

2013 Galectin Therapeutics

NASDAQ:GALT

Galectin Inhibitor GR-MD-02 Effectively

Treats Toxin-Induced Liver Fibrosis in Rats

Treatment with vehicle alone for

four weeks (Control) shows

robust fibrosis

Treatment with GR-MD-02 for four

weeks shows dramatic regression

of fibrosis

Galectin Therapeutics Data

Liver fibrosis induced in all rats by injection of chemical

toxin (thioacetimide) for 8 weeks

2013 Galectin Therapeutics

NASDAQ:GALT

2013 Galectin Therapeutics

NASDAQ:GALT

GR-MD-02 Markedly Improved NASH (Non-Alcoholic

Steatohepatitis) in a Mouse Model

Vehicle

GR-MD-02

NASH was induced in mice by rendering them diabetic and

feeding them a high fat diet

2013 Galectin Therapeutics

NASDAQ:GALT

GR-MD-02 Prevented and Completely Reversed

Fibrosis in NASH Mouse Model

Early Treatment

Late Treatment

normal

mouse 0.33

2013 Galectin Therapeutics

NASDAQ:GALT

Early and Late Therapy Compiled Data

2013 Galectin Therapeutics

NASDAQ:GALT

Treatment with GR-MD-02 Markedly

Reduces Galectin-3 in NASH Mice

Vehicle

GR-MD-02

Immunohistochemistry for detection of Galectin-3

2013 Galectin Therapeutics

NASDAQ:GALT

Inhibition of Gal-3 May Have Multiple Sites

of Action in Therapy of NASH

Extracellular

Matrix

Cytokines

ECM Dissolution

MMPs

Inflammation

ceases

Stellate Cells

Macrophages

Gal-3

Stellate Cell

Release of multiple inflammatory

cytokines,

including

TGF-

critical

mediator of fibrosis

Quiescent

Activated

Hepatocyte

Macrophage

T-Cell

Bile Duct Cell

Lipo-peroxidation Products

Scavenger receptor increases

cellular uptake of toxic products

Inhibit scavenger mechanism

and reduce cellular toxicity

Galectin

GR-MD-02

Increases

TGF-

receptor

signaling

Reduce

cell

membrane

TGF-

receptor activity

Promotes activation of stellate

cells to myofibroblasts

Reduces activation of stellate

cells

? Effect on ECM dissolution;

Macrophages

2013 Galectin Therapeutics

NASDAQ:GALT

Gal-3 expression and activation

of macrophages

Reduces Gal-3 and activation of

macrophages; changes in

macrophage subtypes?

Hyperglycemia

Adipocytokines

Free Fatty Acids

Metabolic Syndrome

Glucose

Intolerance

Fat

Accumulation

Impaired Lipid

Metabolism

Cause of

Liver Injury

Mediators

Inflammation

Fibrosis

Resolution

Targeting Anti-Galectin Therapy In The

Progression of NASH

Decades

Because of effect on inflammation in NASH and ability to reduce existing

fibrosis,

our

clinical

program

will

target

NASH

patients

with

advanced

fibrosis

2013 Galectin Therapeutics

NASDAQ:GALT

Development of Obesity

Insulin Resistance/Diabetes

Steatosis (fatty liver)

NASH

Fibrosis

Cirrhosis

2012

2013

2014

Phase 1 NASH trial

NASH

NASH Development Program: GR-MD-02

Phase 2 NASH Trial

File Fast Track Designation to be filed; Breakthrough Designation following Phase 1

IND

Submitted

Phase 1 Trial:

Patient

Inclusion:

Phase 2 Trial:

Patient Inclusion:

Biopsy proven NASH with advanced fibrosis

2013 Galectin Therapeutics

NASDAQ:GALT

Timelines on final design

First patient

enrolled

Top line

results

First patient

enrolled

Pre-Clinical Completed

Serum

biomarkers

assess

for

pharmacodynamic

effect

Patient

safety

Four

weekly

doses

per

cohort

with

escalation

target

dose

Biopsy

proven

NASH

with

advanced

fibrosis

Design

Primary

Endpoint

Secondary

Endpoints

Secondary

Endpoints

Safety;

Serum

biomarkers,

MR-fat

and

elastography

Primary Endpoint

Liver biopsy evaluated for percent area collagen

Design

Randomized, controlled, double blinded study with at least six

months of therapy

Examples of Therapeutic Approaches Under

Investigation for Therapy of NASH

General Mechanism

Examples

Comments

Obesity

•

Lifestyle, dieting

•

Can be beneficial; not effective in advanced NASH

Treat Diabetes and

Insulin Resistance

•

Pioglitazone

•

Failed to achieve significant endpoints in phase 2 and

phase 3 clinical trials, but some evidence of effect

Lipid Metabolism

•

Aramchol & others

•

Cholesterol inhibition, no clinical results

Modulate the

Immune System

•

EGS21 (Enzo)

•

Pentoxifylline

•

Abandoned after phase 2 trial

•

Non significant phase 3 results

Protease Inhibition

•

GS-9450 (Gilead)

•

Liver toxicity in phase 2: abandoned

Bile salt metabolism

•

Colesevelam

•

Obeticolic acid

•

Intestinal bile salt binder, Phase 2 trial failed

•

FXR agonist; Phase 2 coming to conclusion

Anti-Oxidant / toxin

metabolism

•

Vitamin E

•

MND-21 (Mochida)

•

Cysteamine

•

Effective in NASH score in phase 3, but not fibrosis

•

Omega-3 fatty acid (phase 2 trial)

•

Phase 2 trial in adolescents underway

Anti-collagen cross-

linking

•

Lysyl oxidase-like-2

mAb (GS-6624,

Gilead)

•

Initiated Phase 2 trials in 2012 in patients with NASH and

fibrosis, top line data Q3 2015.

•

GR-MD-02 is well positioned with respect to competition

•

Most attractive mechanism: multiple sites of action in disease

•

Independent of hyperglycemia or hyperlipidemia

•

May reverse established fibrosis

•

Low toxicity potential as a carbohydrate with no toxic metabolites

2013 Galectin Therapeutics

NASDAQ:GALT

Science of Galectins

Galectin Function

Galectin Inhibitors

Intellectual Property

Immune Enhancement in Cancer Therapy

Mechanism of Action

Regulatory and Clinical Plan

Competitive Positioning

Liver Fibrosis

Mechanism of Action

Regulatory and Clinical Plan

Competitive Positioning

Milestones

2013 Galectin Therapeutics

NASDAQ:GALT

Key Company Milestones: 12 months

•

Cancer

•

Phase I/II (IIa) metastatic melanoma trial, first patient infused 5/12

•

Five patients currently enrolled; stage 1 data likely available in first

half of 2013.

•

NASH with Advanced Fibrosis (Fatty Liver Disease)

•

1/30/13: IND Submitted to FDA

•

3-4/13: Initiate Phase 1 NASH trial

•

1/14: Phase 1 NASH trial results

•

Q1 2014: Initiate Phase 2 NASH trial

•

Top line data from Phase 2 trial TBD based on design

2013 Galectin Therapeutics

NASDAQ:GALT

Finances & Capitalization

Common Stock

Shares (9/30/12)

Common Shares

15,966,437

Preferred Series A

(converted)

260,430

Preferred: Series B

(converted)

2,000,000

Preferred: Series C

(converted)

366,680

Warrants: Series B*

5,000,000

Other Warrants**

2,424,241

Options Outstanding***

3,541,630

Total Outstanding

29,559,418

* Exercise Price: $3.00 (all controlled by 10X Fund)

** Weighted Average Exercise Price: $4.97

Cash on Hand: $11.1 million (at 9/30/12)

Funded to Jan 2014 (based on current planned R&D)

*** Weighted Average Exercise Price: $5.88

2013 Galectin Therapeutics

NASDAQ:GALT

Total Outstanding

Management,

Officers and

Directors

10X Fund

(includes Series

B Shares)

Series A Shares

Series C Shares

Other Warrants

and Options

Publicly Traded

Warrants

Public Float

Proprietary

Compounds

•

First in class, proprietary compounds that inhibit galectin proteins

•

Complex carbohydrate drugs with highly favorable safety profile

•

GM-CT-01: Enhanced ability of immune cells to kill of cancer cells

•

GR-MD-02: Potential to treat non-alcoholic steatohepatitis (NASH)

and other causes of liver fibrosis

Validated Science

•

Pre-clinical models show galectins are critical targets for intended

diseases with mechanisms that would be novel in the market

Large Market

Opportunities

•

Enhancing the ability of immune system to kill cancer cells is

synergistic with many current and experimental therapies

•

NASH and liver fibrosis indications would be first therapies for

completely unmet medical needs, representing a multi-billion

dollar market

Intellectual Property

•

Sole ownership, no licenses granted

•

GM-CT-01: Matter and methods granted (expire 2023)

•

GR-MD-02: Use in liver fibrosis (expire 2026); Matter pending

(priority of 2011)

Experienced

Management Team

•

Management team has collective experiencer in multiple biotech

and Pharmaceutical companies and relevant scientific areas

Investment Highlights

2013 Galectin Therapeutics

NASDAQ:GALT

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