Galectin Therapeutics (GALT) 8-K Results of Second Cohort

GT-020 Phase 1 Clinical Trial:

Results of Second Cohort

July 29, 2014

NASDAQ: GALT

www.galectintherapeutics.com

©

2014 Galectin Therapeutics inc.

Exhibit 99.1

Forward-Looking Statement

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 GR-MD-02 and expectations regarding the clinical trial,

including the future enrollment of patients and the timing of results from the third cohort. Factors that

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

statements include, among others, that results from the first and second cohorts of Phase 1 may differ

materially from future results, and there is no guarantee that the current clinical trial will lead to positive

outcomes or that GR-MD-02 will ever be approved by the FDA.  We may experience delays in the

current

trial,

and

we

may

have

difficulty

enrolling

patients

and

processing

the

resulting

data.

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.

Regardless

of

the

results

of

current

or

future

studies,

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. To date, we have incurred operating losses since our

inception, and our ability to successfully develop and market drugs 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.

2

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Our Pipeline Of Galectin-3 Inhibitors

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

3

Clinical Focus

Stage of Development

Drug

Indication

Discovery

Pre-clinical

Phase 1

Phase 2

Phase 3

Fibrosis

GR-MD-02

Fatty liver disease with

advanced fibrosis

Lung fibrosis

Kidney fibrosis

Cardiac fibrosis

Cancer Immunotherapy

GR-MD-02

Melanoma

Galectin-3 Inhibitors

GR-MD-03

Subcutaneous

GR-MD-04

Oral

GS compound*

Oral

*Galectin Sciences, LLC

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

NASH With Advanced Fibrosis (Stage 3 and 4)

4

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Obesity/Insulin Resistance/Diabetes

Steatosis (fatty liver)

NASH (inflammation, cell death)

Stage 1       2       3

Fibrosis

Stage 4

Cirrhosis

•

No certainty of progression from early to late disease in an individual

•

Late disease much closer to clinical outcomes

•

Surrogates of clinical outcomes are better developed for late disease

•

GR-MD-02 reduces inflammation, ballooning and fat in NASH and reduces

existing fibrosis and reverses cirrhosis in animal models

Early Disease

Late Disease

Clinical Outcomes:

Complications

Transplant

Death

Targeting Late Disease

Summary

of

Findings:

Primary Endpoints Were Met In Cohort 2

•

GR-MD-02 was safe and well tolerated at dose of 4 mg/kg (80/160 mg/m

2

),

similar to the findings of the 2 mg/kg dose in the first cohort.

•

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 4 mg/kg, a dose that correlates with a therapeutic dose in

animal model of NASH.

5

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Summary of Findings:

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.

•

While the overall impression of biomarker analysis suggests 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.

6

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

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

Advanced Fibrosis

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

7

Changes in Cohort 2 Protocol:

•

Based on the pharmacokinetics of the drug determined from the first cohort, the protocol

was shortened by 18 days:

•

The second dose was given on day 21 instead of day 28

•

The

timing

of

serum

biomarker

evaluations

were

shortened

from

14

to

3

days

after

the

fourth and final infusion

•

FibroScan evaluation was added to obtain experience with the method

1

st

Infusion

Cohort

Patients

(A/P)

6/2

1

(2 mg/kg)

*BM=Serum Biomarkers

**FS=FibroScan

®

2

nd

Infusion

3

rd

Infusion

4

th

Infusion

Cohort 3 Plan For Phase 1 Clinical Trial Of GR-MD-02

In NASH With Advanced Fibrosis

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

8

12/8

BM*/FS**

BM*/FS**

BM*/FS**

BM*

*BM=Serum Biomarkers

**FS=FibroScan

®

3

(8 mg/kg)

0

28

35

42

56

Day

1

st

Infusion

-1

BM*/FS**

BM*/FS**

Cohort

Patients

(A/P)

6/2

7/2

21

28

35

0

-1

1

(2 mg/kg)

38

BM*

BM*

2

(4 mg/kg)

2

nd

Infusion

3

rd

Infusion

4

th

Infusion

Day

Cohort 3 incorporates four time points for comparative evaluation

21

28

35

49

0

-1

38

Day

9

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Cohort 1 (2 mg/kg)

Cohort 2 (4 mg/kg)

Patients Enrolled

8

10

Male/Female

2/6

6/4

Age Range (Mean)

40-64 (54)

34-69 (51.5)

BMI (Mean)

39

39.6

Diabetic Patients

6

4

Fibrosis Stage

Stage 3: 7 patients

Stage 4:1 patient

Stage 3: 6 patients

Stage 3/4: 4 patients

Patient Characteristics

10

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Cohort 1 (2 mg/kg)

Cohort 2 (4 mg/kg)

Completed Protocol

8

9

(One patient withdrawn because of

baseline (pre-drug) borderline QTc

interval prolongation)

Serious Adverse Events

0

0

Treatment Emergent AE’s

scored as probably related to

drug

0

0

Treatment Emergent AE’s

scored as possibly related to

drug

0

Patient 1:

transient yellow

toenails and left ankle edema

which were mild (grade 1) and of

<1 day duration. Intermittent PRI

prolongation unrelated to infusion

(grade 1).

Patient 2:

right swollen wrist and

painful right ankle which were

mild (grade 1) and of <1 day

duration.

Patient Safety: GR-MD-02 At Doses Of 2 And 4 mg/kg

Were Safe And Well Tolerated

Independent

Data

Safety

Monitoring

Board

Approved

Proceeding

to

Cohort

3

Mean GR-MD-02 Plasma Concentration-Time Profiles

After First And Fourth Doses In Cohorts 1 And 2

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

11

There was a proportional increase in total drug exposure with doubling

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

2 mg/kg (1

st

/4

th

dose)

C

max

= 16.3/17.7 µg/mL

T

1/2

= 19.9/20.5 h

AUC = 573/645 h*µg/mL

V

ss

= 5.2/4.7 L

Variability

15/24%

4 mg/kg (1

st

/4

th

dose)

C

max

= 30/31 µg/mL

T

1/2

= 19.8/19.5 h

AUC = 1039/1075 h*µg/mL

V

ss

= 6.4/6.0 L

Variability

25/35%

Exploratory Serum Biomarkers Of Fibrosis And

Inflammation In NASH

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

12

Fibrosis Composite Scores

FibroTest™

(FibroSURE™)

•

Indirect biomarker of fibrosis

•

Age and gender, Alpha-2-

macroglobulin, Haptoglobin,

Apolipoprotein A1, GGTP, Total

bilirubin

ELF (Enhanced Liver Fibrosis)

Score

•

Direct biomarker of fibrosis

•

Hyaluronic acid

•

TIMP1 (tissue inhibitor of

metalloproteinase-1)

•

P3NP (amino terminal

propeptide of type III pro-collagen)

For

more

information

and

references

on

biomarkers:

http://bit.ly/1jzFK50

Inflammatory Cytokines

Cellular Injury

Serum Transaminases

•

ALT and AST

•

Enzymes released from liver cells

•

2/3 of NASH patients have normal

levels at any given time

•

Entire spectrum of disease can be

seen with normal levels

ELF Scores In GR-MD-02 Treated Patients of Both

Cohorts

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

13

•

ELF scores tended to be reduced in the patients in the first cohort

•

ELF scores in the second cohort were more dispersed and tended to

increase over placebo

Interpretation:

•

There is an indication of an effect in

both cohorts, while not statistically

significant.

•

However, there are differences in the

biomarker data between the cohorts,

potentially due to sampling dates.

•

Cohort 1 last sample was taken 14

days after the last infusion, after the

drug has been eliminated.

•

Cohort 2 last sample was taken 3

days after last infusion, a time when

drug is still present.

•

Since ELF is a marker of fibrotic

tissue turnover, there may be

increased turnover at 3 days which

has reached a new lower state at 14

days after last infusion.

Note: Placebo patients from both cohorts were included in analysis

FibroTest

™

(FibroSURE

™

)

Scores

In

GR-MD-02 Treated

Patients of Both Cohorts

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

14

•

FibroTest scores were significantly reduced in the patients in the first cohort

•

Scores were more variable in the second cohort and change did not reach significance

•

The patient with the greatest reduction in score (green circle) was also the patient with

the highest starting score (0.83; range of test is 0 to 1.0)

Note: Placebo patients from both cohorts were included in analysis

Interpretation:

•

Similar to ELF scores, the

differences in the biomarker data

between the cohorts is possibly due

to differences in sampling dates.

•

Cohort 1 last sample was taken 14

days after the last infusion, after the

drug has been eliminated.

•

Cohort 2 last sample was taken 3

days after last infusion, a time when

drug is still present.

•

The greater dispersion of scores in

cohort 2 may also indicate a

fluctuation in the changes in fibrous

tissue.

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

15

TGF-ß

Levels In GR-MD-02 Treated Patients In

Both Cohorts

•

TGF-ß

levels in the patients in the first cohort were unchanged from placebo

•

TGF-ß

levels increased in patients in the second cohort and the change was

significantly increased over placebo and first cohort patients

Note: Placebo patients from both cohorts were included in analysis

Interpretation:

•

These data provide another

indication that there are 

differences in the biomarker data

between the cohorts, potentially due

to sampling dates.

•

Since it is not clear whether

circulating TGF-ß

levels are active, it

is difficult to assign a biological

meaning to these data.

•

However, the data do indicate that

there is some activity at 3 days

following the infusion that is not

identified at 14 days.

Interleukin-8 Levels In GR-MD-02 Treated Patients In

Both Cohorts

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

16

Cohort 1*

Cohort 2*

NAFLD**

Obese

Controls**

IL-8

pg/mL

28.0 ±

8.6

22 ±

9.7

24.1 ±

38.5

7.8 ±

3.6

*Baseline levels

**Jarrar, et al. Aliment. Pharmacol. Ther. 2007

Note: Placebo patients from both cohorts were included in analysis

Interpretation:

•

Baseline IL-8 levels were elevated in

both cohorts.

•

IL-8 levels were significantly

reduced  in cohort 1 but not changed

in cohort 2.

•

These data, along with the TGF-ß

data suggest that the cytokine milieu

is different when sampled at 3 days

versus 14 days following final infusion.

Interleukin-6 Levels In GR-MD-02 Treated Patients In

Both Cohorts

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

17

Cohort 1*

Cohort 2*

NAFLD**

Obese

Controls**

IL-6

pg/mL

6.1 ±

2.5

5.3 ±

1.3

23.1±72.9

7.6±6.3

*Baseline levels

**Jarrar, et al. Aliment. Pharmacol. Ther. 2007

Note: Placebo patients from both cohorts were included in analysis

Interpretation:

•

Baseline IL-6 levels were not

elevated in either cohort.

•

IL-6 levels were significantly

reduced in cohort 1 but not changed

in cohort 2.

•

These data, along with the TGF-ß

data suggest that the cytokine milieu

is different when sampled at 3 days

versus 14 days following final infusion

•

Moreover, IL-6 may not be a good

marker since the levels are not

increased over obese controls.

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

18

TNF-

Levels In GR-MD-02 Treated Patients In

Both Cohorts

Note: Placebo patients from both cohorts were included in analysis

Interpretation:

•

Baseline TNF-

levels were elevated

in both cohorts.

•

TNF-

levels were previously

reported to be significantly reduced

in cohort 1, but this did not hold up

with the additional two placebo

patients included in the analysis.

•

While the variation in placebo values

is large, these data suggest that

there are not changes in TNF-

levels regardless of the timing of

samples after infusion.

*Baseline levels

**Jarrar, et al. Aliment. Pharmacol. Ther. 2007

Alanine Aminotransferase (ALT) Levels In The Two

Cohorts

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

19

Cohort 1 ALT Levels

•

Both

cohorts

had

a

broad

range

of

baseline

ALT

levels,

which

are

known

not

to

correlate with degree of fibrosis or activity of NASH.

•

The first cohort had two patients with ALT over 100 which improved with therapy.

•

There

were

no

patients

with

ALT

over

100

in

second

cohort

and

no

decreases

were seen with therapy.

Patients Had A Normal Range Of Blood Galectin-3

Levels At Baseline And No Change With Treatment

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

20

•

Blood levels of Galectin-3 do not correlate with liver levels in animal models of NASH

•

Blood levels of Galectin-3 do not correlate with severity of disease in human NASH

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

21

FibroScan

®

Analysis In Second Cohort

•

FibroScan

®

is an ultrasound-based measure of shear wave speed in the liver which

correlates with liver stiffness.

•

Approved

by

FDA

as

an

aid

to

clinical

management

of

patients

with

liver

disease.

Not

approved for following changes in liver fibrosis.

•

Test was done primarily to gain experience with the test prior to use in Phase 2 and was

performed

at

sites

where

available

(6

patients

were

evaluated

at

days

-1

and

38.)

All patients had FibroScan

values above the values

predictive of advanced,

stage 3 fibrosis (7.9 kPa).

There were no consistent

changes with therapy.

The large difference in one

placebo patient suggests

more experience is required

with this method in

longitudinal studies.

Summary of Findings:

Primary Endpoints Were Met In Cohort 2

•

GR-MD-02 was safe and well tolerated at dose of 4 mg/kg (80/160 mg/m²),

similar to the findings of the 2 mg/kg dose in the first cohort.

•

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 models.

•

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

safe,

well

tolerated,

and

has

predictable

pharmacokinetics

when

administered

at

4

mg/kg,

a

dose

that

correlates

with

a

therapeutic

dose

in

animal

models

of

NASH.

22

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Summary of Findings:

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.

•

While the overall impression of biomarker analysis suggests 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.

23

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

Next Steps: Completion of Phase 1 Trial

©

2014 Galectin Therapeutics  |  NASDAQ:GALT

24

•

The dose of GR-MD-02 will be 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 to 20 total patients

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

patients in

each group in analysis of the data (including 4 placebos from previous

cohorts).

•

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

study to account for potential sample timing differences following drug

infusion.

•

Patient screening and enrollment for cohort 3 has begun and results are

expected in November 2014.

•

Planning for phase 2 clinical trials is ongoing. The results of the first and

second cohort suggest that 2 and 4 mg/kg are safe and well-tolerated doses,

defining a dose range for phase 2 clinical trials.