Galectin Therapeutics (GALT) 8-K Other Events

Corporate Presentation

September 12, 2014

NASDAQ: GALT

www.galectintherapeutics.com

©

2014 Galectin Therapeutics Inc

Exhibit 99.1

Forward-Looking Statement Disclaimer

2

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

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. These statements include

those regarding potential therapeutic benefits of our drugs, expectations, plans and timelines related to

our clinical trials, potential partnering opportunities and estimated spending for 2014. Factors that could

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

include, among others, our trials may not lead to positive outcomes or regulatory approval.  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

further develop and/or fund any studies or trials. We are currently the subject of litigation, which may

impact our human and capital resources. 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,

2013,

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.

Biopharmaceutical Company Focused On Major

Unmet Medical Needs

3

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Organ Fibrosis

•

45%

of

US

deaths

associated

with

fibrotic

disease

1

•

Lead indication: liver fibrosis/cirrhosis due to fatty liver

disease

(75%

of

all

liver

disease

in

US)

2

•

Potentially applicable to other fibrotic diseases

•

Phase 1 clinical trial will complete in 2014; Phase 2

clinical trial starts H1 2015

Cancer

Immunotherapy

•

Focus on combination immunotherapy with GR-MD-02

•

Lead indication is advanced melanoma

•

Technology applicable to other cancers and

immunotherapies

•

Phase 1B clinical trial in progress

Drugs Target

Galectin Proteins

•

Novel complex carbohydrate drugs that block galectin-3

protein, which is involved in multiple disease processes

•

Robust efficacy in pre-clinical animal models of disease

•

Lead candidate (GR-MD-02) patent protection (Dec. 2031)

1

Wynn, TA. Nat Rev Immunol. 2004;4:583–594. doi:10.1038/nri1412

2

Younossi, et al. Clin. Gasto. Hepatol. 2011;9:524-530

Pipeline

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2014 Galectin Therapeutics  |  NASDAQ:GALT

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*Galectin Sciences, LLC

H1 2015

Clinical Focus

Stage of Development

Drug

Indication

Discovery

Pre-clinical

Phase 1

Phase 2

Phase 3

Fibrosis

GR-MD-02

NASH cirrhosis

Lung fibrosis

Kidney fibrosis

Cardiovascular fibrosis

Cancer Immunotherapy

GR-MD-02

Melanoma

Galectin-3 Inhibitors

GR-MD-03

Subcutaneous

GR-MD-04

Oral

G-XXX*

Oral

Function of Galectin Proteins And Drug Inhibition

5

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Expression &

Function

•

Gal-3 widely expressed; highest in macrophages

•

Modulates cell signaling and immune cell function

•

Promote cell-cell and cell-matrix interactions

Role in Disease

•

Gal-3 expression increased in areas of inflammation

and fibrogenesis

•

Knockout of gal-3 gene in mice prevents fibrosis in

liver, lung, kidney and heart

•

The majority of cancers express high levels of gal-3

Molecular

Interactions

•

Proteins bind to galactose residues in glycoproteins

•

Promote interactions between glycoproteins

•

15 protein family; Gal-3 critical target for therapy

Drug Mechanism

•

GR-MD-02 is a complex carbohydrate with terminal

galactose residues

•

Drug binds to gal-3 and disrupts interaction with

glycoproteins

CIRRHOSIS DUE TO NASH

(NON-ALCOHOLIC STEATOHEPATITIS)

Lead Indication in Organ Fibrosis

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2014 Galectin Therapeutics  |  NASDAQ:GALT

NASH Is Epidemic And There Are

No Approved Therapies

7

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Diabetes

Fatty Liver

NASH

US prevalence in

asymptomatic, middle-aged

adults

US

(%

of

population)

2

Obesity

45%

16.5%

46%

12.2%

2

Prospective evaluation of NAFLD and NASH prevalence (Williams, et al. Gastro. 2011;140:124-131)

Estimated prevalence of NASH in US adults

1, 2

: > 28 million

1

Based on July 2013 US census data for people >20 years old (233,880,752)

The End Stage of Fibrosis (Cirrhosis) Is When Patients

With NASH Experience Symptoms And Complications

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2014 Galectin Therapeutics  |  NASDAQ:GALT

NASH

Complications

(variceal

bleed,

ascites,

encephalopathy)

Liver Transplantation (projected to be leading reason)

Liver-Related Death

Fibrosis

Progression

Stage 1

Stage 2

Stage 3

Stage 4

Liver

biopsy

(Blue = fibrosis)

Cirrhosis

Asymptomatic

Estimated prevalence of advanced fibrosis

1,

2

:      ~ 6 million

Estimated prevalence of cirrhosis

:      ~ 2 million

Approximately 1/3 will advance to

Stage 3/4 fibrosis

2

Williams, et al. Gastro. 2011;140:124-131

1

Kleiner, et al. Hepatology 2005;41:1313-1320

3

Caldwell, et al. Dig Dis 2010;28:162–168

1

3

GR-MD-02 Has Robust Therapeutic Effect On NASH

With Fibrosis And Cirrhosis In Rodent Models

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2014 Galectin Therapeutics  |  NASDAQ:GALT

9

•

GR-MD-02 decreases:

•

NASH Activity

•

Collagen (fibrosis)

•

Galectin-3 protein

1

Traber, et al. PLOS ONE 2013;8:e83481

Normal Stain

Collagen Stain

Gal-3 Stain

Mouse NASH Model

Rat Cirrhosis Model

2

Traber, et al. PLOS ONE 2013;8:e75361

Untreated

GR-MD-02

•

Cirrhosis induced by toxin and

continued with therapy

•

Four, once weekly doses of GR-MD-02

•

Marked reduction in fibrosis, thinned

broken bands (arrow)

•

Cirrhosis reversed

N=nodule

2

1

Fat

Inflammation

Ballooning

GR-MD-02 Is Being Developed For The Indication Of

Cirrhosis Due To NASH

•

Cirrhosis is late disease that is closer to adverse clinical outcomes;

cannot predict which patients with early disease will progress to

cirrhosis

•

Goal of therapy is to reverse fibrosis and cirrhosis, thereby reducing

likelihood of adverse clinical outcomes and transplantation

•

Regulatory pathway to approval better defined because potential

surrogates of clinical outcomes are more developed for late disease

•

This is an appropriate target population because GR-MD-02 treats

NASH and reduces existing fibrosis and reverses cirrhosis in pre-

clinical models

•

Majority of companies developing NASH therapies are targeting early

disease, including:

•

Intercept, Genfit, Galmed, Raptor, and others

•

Only company with phase 2 program in NASH cirrhosis is Gilead   (anti-

LOXL2 monoclonal antibody)

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Phase 1 Clinical Trial Of GR-MD-02 In NASH With

Advanced Fibrosis: Fast Track FDA Designation

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2014 Galectin Therapeutics  |  NASDAQ:GALT

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Biomarkers

Biomarkers

Patient:

Biopsy proven NASH with advanced fibrosis (at least stage 3)

Ascending

dose

cohort;

single

and

multiple

dose

First 2 cohorts enrolled, have at least 8 patients (6 active, 2 placebo);

Third cohort has up to 20 patients total 

Doses:

2 mg/kg, 4 mg/kg, and 8 mg/kg in the three cohorts, respectively

Primary endpoints:

Safety

Pharmacokinetics (PK)

Secondary endpoints:

Disease-related serum biomarkers to assess for

potential treatment effect

http://clinicaltrial.gov/ct2/show/NCT01899859?term=GR-MD-02&rank=2

1 week

1 week

3/4 weeks

Design

:

Primary Endpoints Were Met In Cohort 1 and 2

•

GR-MD-02 was safe and well tolerated at doses of 2 mg/kg and 4 mg/kg

•

The independent Data Safety Monitoring Board (DSMB) approved moving

forward with Cohort 3.

•

Pharmacokinetics revealed a proportional increase in total drug exposure with

doubling of the dose of GR-MD-02 with no accumulation after four doses.

•

A dose of 4 mg/kg provided drug exposure in humans that was roughly

equivalent to the lowest therapeutic dose used in NASH animal model.

•

The drug half-life in humans is approximately 4 times longer than in mouse at

similar doses providing a more extended exposure in humans.

GR-MD-02 was safe, well tolerated, and has predictable pharmacokinetics

when administered at up to 4 mg/kg, a dose that correlates with a

therapeutic dose in animal model of NASH.

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Exploratory Secondary Endpoints

•

While the current gold standard for the evaluation of NASH with advanced

fibrosis is liver biopsy, it is not appropriate to subject individuals to serial liver

biopsies over a short Phase 1 clinical trial. Biopsy assessment of liver fibrosis

will be the primary endpoint in the Phase 2 clinical trial to follow this trial.

•

To

potentially

gain

some

understanding

of

drug

effect

and

to

aid

in

planning

of

a Phase 2 clinical trial, exploratory biomarkers were evaluated before and

after therapy. (note: these biomarkers are not clinically validated as an

acceptable primary endpoint for efficacy in fibrosis treatment).

•

While the overall impression of biomarker analysis suggested there may be

an effect of the drug, there are differences in biomarker changes depending

on the timing of blood sampling with respect to drug dose.

•

Since biomarker results are not directly comparable between cohort 1 and

cohort 2, a comparison of the effect of timing on biomarkers will be evaluated

in cohort 3.

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Next Steps: Completion of Phase 1 Trial

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2014 Galectin Therapeutics  |  NASDAQ:GALT

14

•

The dose of GR-MD-02 was increased to 8 mg/kg (320 mg/m

2

) in the third and

final

cohort,

a

dose

projected

to

be

well

within

the

therapeutic

range

as

predicted in pre-clinical studies.

•

The number of patients in the third cohort will be expanded up to 20 total

patients (12 active drug and 8 placebo) which will allow comparison of a larger

number of patients.

•

Blood biomarker analysis will be conducted at four time points during the study

to account for potential sample timing differences following drug infusion.

•

Nine

(9)

patients

are

currently

enrolled

in

cohort

3

and

results

are

expected

in

November 2014.

Next Steps: Phase 2 Clinical Trial

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2014 Galectin Therapeutics  |  NASDAQ:GALT

15

•

Planning for phase 2 clinical trials is ongoing

•

Phase 2 trial will be initiated in H1 2015; details of the trial(s) will be

announced when planning is complete

•

The results of the first and second cohort suggest that 2 mg/kg and 4 mg/kg

are safe and well-tolerated doses, and we are now testing 8 mg/kg.

•

The doses for evaluation in Phase 2 will be chosen using the correlation of

therapeutic doses in pre-clinical animal studies and blood levels of GR-MD-02

determined

in

the

Phase

1

trial.

Biomarkers

in

Phase

1

study

are

not

integral

to choosing Phase 2 doses. 8 mg/kg dose is expected to be well within

therapeutic dose range.

•

Patient population will have cirrhosis due to NASH

•

Study endpoints and other particulars of clinical trials, including duration, are

under discussion with the FDA

Fibrosis Program Summary

•

First liver fibrosis indication: NASH with cirrhosis, a major

unmet medical need

•

Current Phase 1 trial results shows safety of four doses of 2

mg/kg and 4 mg/kg.

•

Controlled phase 2 clinical trial program to follow completion of

phase 1 trial.

•

The current results of the Phase 1 trial this defines at least two

potential dose levels for phase 2 clinical trials

•

Other Organ Fibrosis

•

Pre-clinical efficacy results in lung, kidney and cardiovascular fibrosis

•

Considering prospects for entering clinical development

•

Ongoing discussions with large pharmaceutical companies

•

Discussions

will

provide

foundation

for

partnering

opportunities

at

the

most opportune time

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©

2014 Galectin Therapeutics  

NASDAQ:GALT

ADVANCED MELANOMA

Lead Indication in Cancer Immunotherapy

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2014 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

•

18

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2014 Galectin Therapeutics  

NASDAQ:GALT

Tumor immunity

has

recently been shown to be

critically affected by

galectins

Cancer Therapy Strategy

•

Focus on cancer immunotherapy based on the hypothesis that

galectin inhibitors will enhance efficacy of immunotherapies

•

Many cancers secrete large amounts of galectins & have multiple roles in

tumor pathogenesis –

importantly on tumor immunity

•

Metastatic melanoma is initial cancer indication

•

In US 76,000 new diagnoses and 9,100 deaths annually

•

Even with newly approved drugs, still a substantial unmet medical need

•

Critical collaboration established

•

Robert W. Franz Cancer Research Center, Earle A. Chiles Research

Institute (EACRI) Providence-Portland Medical Center, Portland Oregon

•

Demonstrated clinical trial expertise in melanoma

•

Tumor immunology basic science research

•

Ability to conduct clinical trials and assist in funding

19

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2014 Galectin Therapeutics  

NASDAQ:GALT

Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-

Tumor Immunity, Reduces Tumor Size And Increases

Survival In Mouse Cancer Models

20

aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy, BMS)]

aPD-1 = anti-PD-1 mAb [positive results in clinical trials, BMS, Merck]

Unpublished data 2013: Stefanie N. Linch, Melissa J. Kasiewicz, Peter G. Traber, and William L.

Redmond, Galectin Therapeutics and Earle A. Chiles Research Institute (EACRI), Portland Oregon

©

2014 Galectin Therapeutics  

NASDAQ:GALT

*p<0.05

These studies on TC-1 prostate cancer cells (also effective in breast

cancer, melanoma, and sarcoma)

Hypothesis: GR-MD-02 May Be A Complimentary Therapy To

Enhance Efficacy Of Immune Checkpoint Blockade Therapies

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2014 Galectin Therapeutics  |  NASDAQ:GALT

21

ICB = Immune Checkpoint Blockade

Phase 1B Clinical Trial in patients with advanced melanoma

using GR-MD-02 in combination with Yervoy®

(ipilimumab):

Actively Enrolling

22

1

23

43

64

85

Day

Infusion:

GR-MD-02

followed

by

Yervoy®

at

standard

doses

Endpoints:

Followed every 12 weeks for survival

Biopsy

Biopsy

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2014 Galectin Therapeutics  

NASDAQ:GALT

http://clinicaltrial.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=1

Patient inclusion:

Design: 3+3 dose escalation (3 patients if no adverse events); 10 patients treated with

maximum tolerated dose

Dose: Starting dose of 1 mg/kg

Advanced

melanoma

with

indication

for

Yervoy®

treatment

Safety; Pharmacokinetics

Tumor response: immune response RECIST criteria

Biological responses including memory CD4+ T-cells, memory CD8+ T-cells, melanoma

specific T-cells, and composition of tumor immune infiltrate from tumor biopsies when

available.

Cancer Therapy Summary

•

Two immunotherapy agents have been approved for use to

date, with many more vaccines and activators in development

•

Our strategy is to leverage world class expertise in basic tumor

immunology and in the conduct of melanoma clinical trials.

•

Providence Portland Medical Center and Earle A. Chiles

Research

Institute

(EACRI)

accepted for  phase 1B clinical trial in patients with advanced

melanoma treated with a combination of Yervoy and GR-MD-02

•

Initial funding of clinical trial by PPMC/EACRI. Galectin is providing

GR-MD-02 study drug, reference to its IND, and PK analysis

•

Ongoing discussions with large pharmaceutical companies in

the immunotherapy space to seek a partnering opportunity at

the most opportune time

23

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2014 Galectin Therapeutics  

NASDAQ:GALT

Ongoing pre-clinical studies; IND

:

Milestones

24

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Compound

Program

Milestone

Timing

GR-MD-02

NASH Cirrhosis

Complete Phase 1 Trial

End 2014

Start Phase 2 Trial

H1 2015

Phase 2 Results

TBD

GR-MD-02

Melanoma

Complete Phase 1B Trial

End 2015

Key Executive Officers

•

Peter G. Traber, MD –

CEO & CMO

•

President & CEO of Baylor College of Medicine

•

Sr. VP

Clinical

Development

and

CMO

–

GlaxoSmithKline

plc

•

Chairman & CEO of TerraSep, LLC

•

President & CEO of University of Pennsylvania Health System,

•

Chair of Internal Medicine and Chief of Gastroenterology, University of Pennsylvania School of Medicine

•

James Czirr, Exec. Chairman

•

Cofounder of 10X Fund and Managing Member

•

Cofounder of GalectinTherapeutics

•

CEO of Minerva Biotechnologies Corp.

•

Harold H. Shlevin, PhD –

COO & Corporate Secretary

•

Principle/Manager of Bioscience Commercialization

–

Georgia Institute of Technology

•

VP

Operations

&

Commercial

Development

–

Altea

Therapeutics

Inc.

•

President & CEO –

Tikvah Therapeutics

•

President & CEO –

Solvay Pharmaceuticals

•

Cofounder and Sr VP –

Ciba Vision Ophthalmics

•

Jack W. Callicutt –

CFO & Corporate Treasurer

•

CFO of Reach Health, Inc.

•

CFO of Vystar Corporation

•

CFO of IVOX, Inc., Tikvah Therapeutics & Corautus Genetics

•

Deloitte

25

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Key Employees/Consultants

•

J. Rex Horton –

Executive Director of Regulatory Affairs and Quality

Assurance

•

Director

of

Regulatory

Affairs

–

Chelsea

Therapeutics

•

Director

of

Regulatory

Affairs

–

Solvay

Pharmaceuticals,

Inc.

•

Eliezer Zomer, PhD –

Manufacturing and Product Development Head

•

Executive

VP

of

Manufacturing

&

Product

Development

–

Galectin

Therapeutics

•

Founder of Alicon Biological Control

•

VP

of

Product

Development

-

Safe

Sciences,

Inc.

•

VP of R&D –

Charm Sciences, Inc.

•

Elena Chekova, PhD –

Program Manager

•

Director

of

Business

Development

&

Project

Management

–

Pro-Pharmaceuticals

•

Founder

and

CEO

-

Biotine

Consulting

•

VP

of

Business

Development

–

Chiral

Quest

•

Analyst

–

McKinsey

&

Berteslmann

AG

26

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2014 Galectin Therapeutics  |  NASDAQ:GALT

Financial

Key

Facts

–

As

of

September

8,

2014

27

Trading Symbol

Nasdaq: GALT

Corporate Headquarters

Norcross, GA (suburb of Atlanta)

Fiscal Year End

December 31

Accounting Firm

McGladrey LLP

Stock Price; 52 Week Range

$5.81        $4.28

-

$19.11

Shares Outstanding

22 million

Daily Volume (3-month average)

733,000 shares

Market Capitalization

$128 million

Debt

$0

Cash & Equivalents (June 30, 2014)

$34.4 million

Estimated Spending in 2014

$14 million

©

2014 Galectin Therapeutics  

NASDAQ:GALT