Galectin Therapeutics 8K Regulation FD Disclosure | GALT 10 Sep 15

Rodman

Renshaw

Annual

Global

Investment Conference

September 10, 2015

NASDAQ: GALT

www.galectintherapeutics.com

Exhibit 99.1

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 2015. 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,

2014,

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

James Czirr, Executive

Chairman

Peter G. Traber, M.D.

President, CEO, CMO

Harold

H. Shlevin, Ph.D.

COO & Corporate

Secretary

Jack

W. Callicutt

CFO

Experienced Executive Leadership Team

Organ Fibrosis

•

45% of U.S. deaths estimated to be associated with

fibrotic disease

•

Lead indication is liver fibrosis/cirrhosis due to fatty liver

disease

(75%

all

liver

disease

U.S.

)

•

Potentially applicable to other fibrotic diseases based on

pre-clinical studies

Cancer

•

Focus on combination immunotherapy, one of the most

promising approaches to cancer therapy

•

Lead indication is advanced melanoma, but technology

applicable to other cancers

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

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

Developing Products For Major Unmet Medical Needs

Role in Disease

•

Gal-3 is increased in inflammation and fibrogenesis

•

Genetic modification in mice that eliminates gal-3 prevents

fibrosis in liver, lung, kidney and heart

•

The majority of cancers express high levels of gal-3, which

promotes tumor growth and inhibits immune response

Galectin-3 Protein

•

Binds to galactose residues (sugars) in glycoproteins and

promotes interactions between these proteins

•

High expression in immune cells (macrophages)

•

Modulates cell signaling and immune cell function

Lead Drug

Candidate

GR-MD-02

Lead Drug

Candidate

GR-MD-02

•

complex carbohydrate that disrupts gal-3 function,

particularly affecting immune/repair function in macrophages

•

Extensive analytical analysis using state-of-the-art methods to

support human use

•

Existing patent coverage through 2031 with 2 composition

and 5 method patents issued

•

Efficacy in preclinical models with encouraging human results

Drugs That Target Galectin-3 Protein May Address These

Unmet Medical Needs

Clinical Focus

Stage of Development

Drug

Indication

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

Fibrosis

GR-MD-02

NASH cirrhosis

NASH advanced fibrosis

Lung, Kidney,

Cardiovascular

fibrosis

Cancer Immunotherapy (combination therapy)

GR-MD-02 +

Yervoy

Melanoma

GR-MD-02 +

Keytruda

Melanoma

Plaque Psoriasis (exploratory)

GR-MD-02

Moderate-severe

New Galectin-3

Inhibitors

Discovery program to identify

subcutaneous and oral forms of

carbohydrates

and oral small molecules

Pipeline of Indications for GR-MD-02

2H 2015

Sept 2015

ADVANCED FIBROSIS AND CIRRHOSIS

DUE TO FATTY LIVER DISEASE

NASH:

(NON-ALCOHOLIC STEATOHEPATITIS)

Lead Indication in Organ Fibrosis

Fatty Liver Disease (NASH) Is An Epidemic With

No Approved Therapies

•

Estimates for number of people with NASH is 18-30M in the US

•

5-9M people in U.S. may have NASH AND advanced fibrosis (Stage 2/3).

1-2M people may have cirrhosis (stage 4), the most advanced disease.

•

Major global problem driven by increasing obesity & diabetes.

•

NASH causes need for liver transplants and affects survival. Patients

with NASH on transplant list increasing nearly 15% per year, while

number of patients with hepatitis C and B are decreasing.

•

U.S. NASH market could be $25 Billion by 2025

•

Based on 1 million patients with advanced NASH being treated in the U.S.

•

Global market (U.S., E.U., and Japan) could be $35-40 Billion by 2025

Who will be the kings of NASH-ville? Key players and an overview. May 21, 2015, Alethia

Young,

Deutsche Bank Markets Research

Extracted

from

Deutsche

Bank

Markets

Research

Fibrosis

Progression

Stage 1

Stage 2

Stage 3

Stage 4

Liver

biopsy

(Blue = fibrosis)

Cirrhosis

Scarring (Fibrosis) Of The Liver In Advanced NASH

Leads To Patient Morbidity and Mortality

Early Disease (low stage fibrosis)

Late Disease (advanced fibrosis)

No increased mortality*

Increased mortality*

*All cause mortality as compared to reference group with prospective follow-up of up to 33

years (Ekstedt, et al. Hepatology 2015;61:1547-1554)

Galectin Therapeutics Is Targeting Late-Stage NASH

•

GR-MD-02 (Galectin)

•

Reduce inflammation*

•

Reduce fibrosis progression*

•

Reverse existing fibrosis*

•

Simtuzumab

(Gilead)

•

Reduce fibrosis progression*

Companies in Phase 2; multiple other companies in discovery and Phase 1

Early Disease (low stage fibrosis)

Late Disease (advanced fibrosis)

Stage 1

Stage 2

Stage 3

Stage 4 (Cirrhosis)

•

Obeticholic

Acid (Intercept)

•

GFT505 (Genfit)

•

Liraglutide

(Novo Nordisk)

•

Aramchol

(Galmed)

•

Cysteamine

(Raptor)

•

Cenicriviroc

(Tobira)

•

Emricasan

(Conatus)

•

PX104 (Gilead/Phenex)

•

KD025 (Kadmon)

•

NGM282 (NGM (Merck))

•

Pradigastat

(Novartis)

•

Roflumilast/Pioglitazone (Takeda)

*Based on effects seen in preclinical studies and mechanisms of action

Strong Scientific Basis For GR-MD-02 Development

Published in Peer-Reviewed Scientific Journals

•

Mouse model of NASH

•

Reduces inflammation, fat, and cell death

•

Prevents as well as reverses fibrosis

•

Rat model of liver cirrhosis

•

Reduces inflammation and cell death

•

Reverses fibrosis and cirrhosis

•

Reduces portal hypertension associated with cirrhosis

Control (No treatment)

GR-MD-02 (4 weekly doses)

•

Study GT-020: Multiple dose escalation, double-blind, placebo-

controlled trial in NASH patients with advanced fibrosis

•

GR-MD-02 was safe and well tolerated

•

Doses in targeted therapeutic window for drug administration

•

Highest dose tested may have an effect on liver fibrosis

•

Reduced serum alpha-2 macroglobulin, a marker of fibrosis

•

Reduced

liver

stiffness

assessed

FibroScan

•

Study GT-029: No interaction between GR-MD-02 and midazolam

•

Adds to strong safety profile

•

Allows for expansion of number of patients eligible to be included in

Phase 2 clinical trials and future commercial population

•

In total, 38 subjects receiving 132 doses of GR-MD-02 showed

excellent safety profile

•

Fast Track designation from FDA

Two Completed Phase 1 Trials Provide Strong

Foundation For Phase 2 Clinical Program

80%

120%

Placebo

GR-MD-02 (8 mg/kg)

3 of 5 patients treated with GR-MD-02 had reduction in liver stiffness to

below 80% of baseline values (red squares)*

Evidence Of Reduced FibroScan

Scores In Cohort 3

Patients Treated With GR-MD-02

*FS added during cohort 2, but only available at most centers for cohort 3. In cohort 3 there were technically adequate scans at

baseline, Day 38 and Day 63 in 5 patients administered GR-MD-02 and 3 patients administered placebo. Five patients in cohort 3 were

not available for FibroScan

analysis (3 placebo and 2 active) because of unavailability of the instrument at the site (1 placebo and 1

active), unavailability of the appropriate instrument probe (1 active), a technically inadequate baseline scan (1 placebo), and the Day

63 scan not being performed (1 placebo).

Phase 2 Clinical Trials Focus On Two Indications In

NASH Patients With Advanced Fibrosis

1 Year of

Therapy

Indication

NASH with

Cirrhosis

(Stage 4)

Objective

Expectation From

Successful Study

Reduction of

portal pressure

and liver fibrosis

Has potential to be

a pivotal trial

NASH-CX

Months of

Therapy

Reduction of liver

fibrosis as assessed

using three non-

invasive tests

Basis for future

Phase 2b or

Phase 3 trials

NASH-FX

NASH with

Advanced

Fibrosis, but

not Cirrhosis

(Stage 3)

With positive results, either of these studies could be basis for FDA Breakthrough application

For more details on clinical trials, please visit clinicaltrials.gov

Summary of NASH Advanced Fibrosis Program

•

Preclinical studies show galectin-3 to be a well-validated target that is

inhibited by GR-MD-02

•

In preclinical models GR-MD-02 has multiple effects

•

Reduces inflammation, fat and ballooning hepatocytes in NASH

•

Reduces and reverses liver fibrosis and cirrhosis

•

Reduces portal pressure, an endpoint of NASH-CX trial

•

NASH is an unmet medical need with a very large potential market

•

GR-MD-02 is well suited to target NASH with advanced fibrosis and

cirrhosis, an area with less competition than early NASH

•

In NASH patients with advanced fibrosis, GR-MD-02 is safe and well

tolerated, therapeutic doses have been defined, and there is evidence

of effect on fibrogenic process in patients

•

Phase 2 clinical trial program addresses different patient populations

•

NASH-CX trial in cirrhosis with top line results end of 2017

•

NASH-FX trial in stage 3 fibrosis with top line results 2H 2016

ADVANCED MELANOMA

Lead Indication in Cancer Immunotherapy

Focus on

Immunotherapy

Focus on

Immunotherapy

•

Immunotherapy is a major breakthrough in cancer

•

Galectin-3 plays an important role in reducing the

ability of immune system to fight cancer

Critical

Collaboration

Established

Critical

Collaboration

Established

•

Robert W. Franz Cancer Research Center, Earle A.

Chiles Research Institute Providence-Portland Medical

Center (PPMC), Portland Oregon

•

Demonstrated clinical trial expertise in melanoma and

tumor immunology basic science research

•

Ability to conduct clinical trials and assist in funding

Cancer Therapy Strategy

Advanced

Melanoma as

Initial Indication

Advanced

Melanoma as

Initial Indication

•

In U.S. 76,000 new diagnoses and 9,100 deaths per year*

•

Even with newly approved drugs, a substantial unmet

medical need remains

*Siegel, et al. CA Cancer J Clin

2012;62:10

GR-MD-02 May Be Used In Combination With Other

Immunotherapies To Enhance Patient Survival

Note: these are illustrative

curves not representative of

actual data; redrawn from

figure of the American

Association for Cancer

Research, 2013

PPMC preclinical studies in mice demonstrated that GR-MD-02 has a

synergistic effect on multiple tumors in combination with other immunotherapies

PPMC Conducting Two Melanoma Phase 1b

Clinical Trials With GR-MD-02

•

Phase 1b Clinical Trial In Patients With Advanced Melanoma

Using GR-MD-02 In Combination With Yervoy®

•

Advanced melanoma with indication for Yervoy

treatment

•

Dose

escalation

with

GR-MD-02

plus

standard

Yervoy

•

Measure tumor and immune system response

•

Two dosing groups complete showing no dose-limiting toxicity

•

Study details on clinicaltrials.gov

•

Phase 1b Clinical Trial In Patients With Advanced Melanoma

Using

GR-MD-02

Combination

With

KEYTRUDA

•

Melanoma

progression

after

Yervoy

and/or

BRAF

targeted

therapy

•

Melanoma progression after KEYTRUDA

monotherapy

•

Remainder of design mirrors first study

•

Plan to initiate in 2H 2015

Summary of Cancer Immunotherapy Program

•

Collaboration with investigative group at PPMC who have

significant expertise in basic tumor immunology and

translational clinical trials

•

Preclinical studies demonstrate in multiple cancers that GR-MD-

02 augments the anti-tumor effects of monoclonal antibody

checkpoint inhibitors

•

Initial target is advanced melanoma, but also applicable to other

cancer types

•

Two Phase 1b clinical trials funded by PPMC

•

May get early evidence of effect since advanced immune

response markers being used to evaluate drug effect in addition

to tumor response

Exploratory Indication

•

Moderate-to-severe plaque psoriasis

•

Patient in Phase 1 trial had apparent remission of severe psoriasis

while receiving 4 mg/kg of GR-MD-02

•

Galectin-3 plays important role in skin and there is increase in skin

vessels of patients with psoriasis

1,2

•

Open-label, single-site, 10-patient study to evaluate the effect of 3

months of GR-MD-02 on the number of patients who have at least

75% improvement in Psoriasis Activity Severity Index (PASI-75)

•

Details on clinicaltrials.gov

•

https://clinicaltrials.gov/ct2/show/NCT02407041?term=GR-MD-02&rank=5

Larsen L, et al. J. Derm

Sci. 2011;64:85-91

Lacina

L, et al. Folia Biologica. 2006;52:10-15

Study

Indication

Endpoints

Start

Data Reporting

Phase 1b:

Yervoy

Advanced

melanoma

Safety

ir-RECIST

Immune

markers

Underway

Dose

Group

complete

Dose

Group

complete

Dose Group 3: initiated

Phase 1b:

KEYTRUDA

Advanced

melanoma

Safety

ir-RECIST

Immune

markers

2h 2015

TBD

Advanced Liver Fibrosis/Cirrhosis

Advanced Melanoma

Study

Indication

Endpoints

Start

Data

Reporting

GT-026

“NASH-CX”

NASH with cirrhosis

Portal pressure (HVPG);

liver biopsy

Underway

End 2017

GT-028

“NASH-FX”

NASH with

advanced fibrosis

Multi-parametric MRI

Comparisons

include

MRE and FibroScan

Sept.

2015

2H 2016

Expected Development Program Milestones

Study

Indication

Endpoints

Start

Data Reporting

Phase 2a:

GT-030

Moderate-to-severe

plaque psoriasis

Psoriasis Activity

Severity Index (PASI

75)

Sept. 2015

Q3 2016

Psoriasis

Program Summary

•

NASH (non alcoholic steatohepatitis) is an unmet medical need

with a very large potential global market

•

Late-stage NASH, with advanced fibrosis/cirrhosis is desirable

from regulatory and commercial perspectives

•

Preclinical studies with GR-MD-02 indicated positive effects on

multiple aspects of NASH, including fibrosis reversal

•

Completed Phase 1 studies demonstrated drug was safe and well

tolerated and provided proof-of-concept on anti-fibrotic activity

•

Currently engaged in two Phase 2 NASH clinical trials in cirrhosis

and advanced fibrosis without fibrosis

•

Investigator-initiated studies in cancer immunotherapy and

psoriasis enhance the GR-MD-02 opportunity

•

Strong executive leadership team with extensive experience

Company Blog: CEO Perspectives

•

New communication feature to provide in depth information on clinical

development programs and other news

•

http://perspectives.galectintherapeutics.com/

•

Most recent posts

•

The Potential for Treatment of Liver Fibrosis With Galectin’s Drug Candidate GR-MD-02

•

Clinical Development Program in Liver Fibrosis

•

Successful Phase 1 Clinical Trial Supports Phase 2 Clinical Development Program

•

Clinical Trial to Establish Efficacy of GR-MD-02 in NASH Cirrhosis

•

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NASDAQ: GALT

Galectin Therapeutics (GALT) 8-KRegulation FD Disclosure