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8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 11, 2015

 

 

GALECTIN THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

 

 

Nevada   001-31791   04-3562325

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

4960 PEACHTREE INDUSTRIAL BOULEVARD, Ste 240

NORCROSS, GA 30071

(Address of principal executive office) (zip code)

Registrant’s telephone number, including area code: (678) 620-3186

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

SECTION 7 – REGULATION FD

 

Item 7.01 Regulation FD Disclosure.

On May 11, 2015, Galectin Therapeutics Inc. posted a corporate presentation on its website that contains, among other information, a summary of development of GR-MD-02 for Non-Alcoholic Steatohepatitis (NASH) With Advanced Fibrosis and Cirrhosis, which presentation is attached as Exhibit 99.1.

The information in this report is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this report.

SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

   

Description

99.1    Corporate presentation

 

- 2 -

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, Galectin Therapeutics Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Galectin Therapeutics Inc.
Date: May 11, 2015 By:

/s/ Jack W. Callicutt

Jack W. Callicutt
Chief Financial Officer

 

- 3 -

EX-99.1
Corporate Presentation
May 11, 2015
NASDAQ: GALT
www.galectintherapeutics.com
©
2015 Galectin Therapeutics Inc.
Exhibit 99.1

2
©
2015 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 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

3
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Organ Fibrosis
•
45% of U.S. deaths estimated to be associated with
fibrotic
disease
1
•
Lead indication is liver fibrosis/cirrhosis due to fatty liver
disease
(75%
of
all
liver
disease
in
U.S.
2
)
•
Potentially applicable to other fibrotic diseases based on
pre-clinical studies
•
Phase 1 clinical trial completed
•
Phase 2 trials in two NASH indications to start Q2 2015
Cancer
Immunotherapy
•
Focus on combination immunotherapy, one of the most
prominent approaches to cancer therapy
•
Lead indication is advanced melanoma, but technology
applicable to other cancers
•
Phase
1b
trial
in
combination
with
Yervoy
3
in
progress
•
Phase
1b
trial
in
combination
with
KEYTRUDA
4
expected
to start Q3 2015
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
Developing Products For Major Unmet Medical Needs
3
Registered trademark, Bristol Myers Squib
4
Registered trademark, Merck Sharp Dome

4
Experienced Leadership Team
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

5
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
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 and inhibits immune response
Galectin-3 Protein
Function
•
Binds to galactose residues 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
•
A complex carbohydrate with terminal galactose residues
that binds to gal-3 and disrupts function, particularly
affecting immune/repair function in macrophages
•
Efficacy in preclinical models of fibrotic disease and cancer
immunotherapy with encouraging early human results
•
Existing patent coverage through 2031 with 2 composition
and 4 method patents issued
Lead Drug Candidate Targets Galectin-3 Protein

ADVANCED FIBROSIS AND
CIRRHOSIS DUE TO NASH
(NON-ALCOHOLIC STEATOHEPATITIS)
Lead Indication in Organ Fibrosis
6
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

7
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
U.S. Prevalence in
Asymptomatic Adults
(%
of
population
studied)
2
45%
17%
46%
12%
2
Prospective evaluation of NAFLD and NASH prevalence (Williams, et al. Gastro. 2011;140:124-131)
Note: population recruited for this study were between ages 18 and 70
Estimated prevalence of NASH in U.S. adults
1, 2
> 28 million
1
Based on July 2013 US census data for people >20 years old
Obesity
Obesity
Diabetes
Diabetes
Fatty Liver
Fatty Liver
NASH
NASH
NASH: An Epidemic With No Approved Therapies

8
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Complications (variceal bleeding, 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
Estimated US prevalence of advanced fibrosis
1,2
:         ~ 6 million
Estimated
US
prevalence
of
cirrhosis
1
:
~
1-2
million
Approximately one-third will
advance
to
Stage
3/4
fibrosis
3
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
End-Stage Fibrosis (Cirrhosis) Is When Patients With
NASH Experience Symptoms And Complications
Early Disease (low stage fibrosis)
Late Disease (advanced fibrosis)

NASH Stage 2 Competitive Landscape*
9
•
Simtuzumab (Gilead)
•
Emricasan (Conatus)
•
GR-MD-02 (Galectin)
•
Obeticholic Acid (Intercept)
•
GFT505 (GenFit)
•
Liraglutide (Novo-Nordisk)
•
Aramchol (Galmed)
•
Cysteamine (Raptor)
•
Cenicriviroc (Tobira)
•
Emricasan (Conatus)
©
2015 Galectin Therapeutics   NASDAQ:GALT
•
Regulatory endpoints for late stage disease better defined and closer to
clinical outcomes including complications of cirrhosis, liver transplant,
and death
•
Ultimately, combination therapies may be employed with agents that are
tailored to different disease stages
* Multiple other companies in discovery and Phase 1
Stage 1
Stage 2
Stage 3
Stage 4
Early Disease (low stage fibrosis)
Late Disease (advanced fibrosis)

Published Preclinical Data Shows That GR-MD-02 Can
Reverse NASH, Fibrosis, and Cirrhosis
•
Mouse model of NASH
•
Reduces inflammation, fat, and cell death
•
Prevents as well as reverses fibrosis
•
Targets macrophages and reduces galectin-3
•
Peer reviewed publication:
•
Traber PG and Zomer E. Therapy of Experimental NASH and Fibrosis
with Galectin Inhibitors. PLOS ONE 2013;8:e83481
•
Rat model of liver fibrosis/cirrhosis
•
Reduces inflammation and cell death
•
Reverses fibrosis and cirrhosis
•
Reduces portal hypertension associated with cirrhosis
•
Targets macrophages and reduces galectin-3
•
Peer reviewed publication:
•
Traber PG, Chou H, Zomer E, Hong F, Klyosov A Fiel M-I, Friedman,
SL. Therapy of Regression of fibrosis and reversal of cirrhosis in
rats by galectin inhibitors in thioacetamide-induced liver disease.
PLOS ONE 2013;8:e75361.
10
©
2015 Galectin Therapeutics  |  NASDAQ: GALT

11
Vehicle-Treated
GR-MD-02-Treated
(4 weekly doses)
*Traber PG, Chou H, Zomer E, Hong F, Klyosov A Fiel M-I, Friedman, SL. Therapy of Regression of
fibrosis and reversal of cirrhosis in rats by galectin inhibitors in thioacetamide-induced liver disease.
PLOS ONE 2013;8:e75361.
GR-MD-02 Reversed Cirrhosis In Rat Model*
Toxin induced cirrhosis in rats; toxin continued during GR-MD-02 treatment
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Reduces portal pressure which correlates with primary endpoint in planned cirrhosis trial

•
Multiple dose escalation, double-blind, placebo
controlled trial in NASH patients with advanced fibrosis
•
GR-MD-02 up to 8 mg/kg IV was safe and well tolerated
•
8 mg/kg IV is in the upper range of the targeted
therapeutic window for drug administration
•
The combined results of a reduction in serum alpha-2
macroglobulin and a reduction in liver stiffness as
assessed by FibroScan
®
suggests that GR-MD-02 at the
highest dose tested may have an effect on liver fibrosis
•
Results provide strong foundation for entering Phase 2
12
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase 1 Trial Completed December 2014

13
p < 0.005
5
p < 0.001
5
p < 0.05
5
2
nd
dose
4
th
dose
+ 14 da
4
th
dose
+ 3 da
Cohort 3
8 mg/kg
4
th
dose
+ 14 da
Cohort 1
2 mg/kg
4
th
dose
+ 3 da
Cohort 2
4 mg/kg
ns
3
ns
4
Legend and Notes:
1.
Mean ±
standard deviation
2.
Placebo values were combined
for all three cohorts because
there were no differences
(n=19 separate data points)
3.
Not significant versus
placebo, two-sided t-test (n=6)
4.
Not significant versus placebo,
two-sided t-test (n=7)
5.
Significant for three groups
versus placebo, ANOVA with
Dunnett’s test for multiple
comparisons (n=7)
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Highly Significant Reduction In Alpha-2 Macroglobulin
Serum Levels Seen At The 8 mg/kg Dose
A
reduction
in
serum
alpha-2-macroglobulin
accounted
for
the
reduction
in
FibroTest
®

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
14
80%
100%
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
*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 NASH Clinical Development Program Includes Trials
In Two Separate Indications In NASH With Advanced Fibrosis
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
15
1 Year of
Therapy
Indication
NASH with
Cirrhosis
(Stage 4)
Objective
Expectation From
Successful Study
Reduction of portal
pressure and fibrosis
based on HVPG, liver
biopsy, and non-
invasive tests
•
Could be a pivotal
trial in conjunction
with another P3 trial
•
Could be basis for
FDA Breakthrough
Designation
NASH-CX
4 Months of
Therapy
Reduction of liver
fibrosis as assessed
using three non-
invasive tests
•
Could serve as basis
for P2b or P3 trials
•
Could be basis for
FDA Breakthrough
Designation
NASH-FX
NASH with
Advanced
Fibrosis, but
not Cirrhosis
(Stage 3)

16
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
The NASH-CX Trial (GT-026)
•
Primary Endpoint:
•
Reduction of hepatic venous pressure gradient (HVPG) as a measure of portal
pressure compared to placebo at 1 year of treatment
•
Secondary Endpoints:
•
At least one stage change in histopathological fibrosis stage
•
Liver collagen on liver biopsy (digital morphometric analysis)
•
Liver
stiffness
as
determined
by
FibroScan
®
Score
•
Metabolic
capacity
of
the
liver
as
determined
by
13
C
methacetin
breath
test
•
Progression of cirrhosis as determined by complications

Complications of Portal Hypertension in Cirrhosis
Varices
Ascites
Shunting
Encephalopathy
Liver Cell Function
Fibrosis         Portal Pressure         Complications       
Morbidity and Mortality
©
2015 Galectin Therapeutics  |  NASDAQ: GALT
The Goal is to:
17
(Portal Hypertension = High Blood Pressure in Portal Vein)

18
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
The NASH-FX Trial (GT-028)
Primary Endpoint:
•
Difference between placebo and GR-MD-02 in the baseline adjusted mean change
in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from
LiverMultiScan (LMS), a multi-parametric MRI protocol.
Secondary Endpoints:
•
To determine the baseline-adjusted change in magnetic resonance elastography (as
measured in kPa)
•
To
determine
the
baseline-adjusted
change
in
FibroScan
®
Score
(as
measured
in
kPa)
https://clinicaltrials.gov/ct2/show/NCT02421094?term=GR-MD-02&rank=3

Non-Invasive Assessments of Liver Fibrosis in
NASH-FX trial
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
19
Transient Elastography
(FibroScan™)
LiverMultiScan*
*Perspectum Diagnostics™
Whole liver assessment of
fibrosis using multi-
parametric magnetic
resonance imaging
Regional assessment of
liver for tissue stiffness
(FDA approved)
Echosense™
Normal
MR-Elastography
Whole liver assessment of
stiffness using magnetic
resonance imaging with
mechanical pulse
Vibrator
Probe
Ribs
Transducter

Summary of NASH Advanced Fibrosis Program
•
Galectin-3 a well-validated target in pre-clinical studies
•
GR-MD-02 binds gal-3 and is targeted to macrophages
•
In pre-clinical 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
•
In NASH patients with advanced fibrosis, GR-MD-02 is safe, well
tolerated and therapeutic doses have been defined
•
GR-MD-02 is well suited to target NASH with advanced fibrosis and
cirrhosis, an area with less competition than early NASH
•
Phase 2 clinical trial program address 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
20
©
2015 Galectin Therapeutics  |  NASDAQ: GALT

ADVANCED MELANOMA
Lead Indication in Cancer Immunotherapy
21
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

CD8+
T-Cells
Cytokines (kill tumor cells)
T-Cells
22
Tumor
Cells
Potential Sites Of Action For Galectin Inhibition In
Tumor Immunology
Galectin-3
CD8+
T-Cells
Clonal
Expansion
Potential for galectin
inhibitors to enhance
anti-tumor immune
response
Potential for galectin inhibitors
to enhance anti-tumor activity
of T-cells by blocking
“Galectin Effect”
Galectin-3
Immunotherapies
Checkpoint Inhibitor
Blockage:
anti-CTLA4
anti-PD1
Tumor Vaccines
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

23
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
•
In U.S. 76,000 new diagnoses and 9,100 deaths*
•
Even with newly approved drugs, a substantial unmet
medical need remains
•
Immunotherapy is a major breakthrough in cancer
therapeutics
•
Galectin-3 has an important role in reducing the ability of
immune system to fight cancer
•
GR-MD-02 is efficacious on tumors in combination with
other immunotherapies in animal models
•
Robert W. Franz Cancer Research Center, Earle A. Chiles
Research Institute (EACRI) Providence-Portland Medical
Center, Portland Oregon
•
Demonstrated clinical trial expertise in melanoma and
tumor immunology basic science research
•
Ability to conduct clinical trials and assist in funding
*Siegel, et al. CA Cancer J Clin 2012;62:10
Cancer Therapy Strategy
Focus on
Immunotherapy
Advanced
Melanoma as
Initial Indication
Critical
Collaboration
Established

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
24
1
2
3
4
Years
CTLA-blockade
(Yervoy
®
)
PD-1-blockade
(KEYTRUDA
®
)
Immune checkpoint blockade
Plus GR-MD-02
GR-MD-02 May Be A Complementary Therapy To
Enhance Efficacy Of Immune Checkpoint Blockade
Therapies
Natural History
Note:
these
are
illustrative
curves
not
representative
of
actual
data;
redrawn
from
figure
of
the
American
Association
for
Cancer
Research,
2013

25
aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy
®
, BMS)]
aPD-1 = anti-PD-1 mAb [pembrolizumab in humans (KEYTRUDA
®
) 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
*p<0.05
These data are on TC-1 prostate cancer cells (also effective in breast
cancer, melanoma, and sarcoma)
Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-
Tumor Immunity, Reduces Tumor Size And Increases
Survival In Mouse Cancer Models
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

Patients
Advanced
melanoma
with
indication
for
Yervoy
®
treatment
Design
Three patients per cohort (+3 if serious adverse events) with 10
patients
treated with maximum dose achieved
Dose
GR-MD-02 starting at dose of 1 mg/kg and escalating following each cohort to
8 mg/kg
followed
by
standard
dose
of
Yervoy
®
Primary
Endpoint
Determine
a
safe
dose
of
GR-MD-02
used
in
combination
with
the
approved
dose
of
Yervoy
®
Secondary
Endpoints
•
Measure the response rate as assessed by ir-RECIST criteria
•
Assess the biological activity by measuring:
-
CD4+ T cells with a memory phenotype
-
CD8+ T cells with effector phenotype
-
Melanoma-specific T cells using autologous and/or HLA-matched tumor
-
Examine composition of the tumor immune infiltrate from tumor biopsies
•
Assess quality of life during therapy using the FACT-M questionnaire.
Trial Site
Providence-Portland Medical Center (Dr. Brendan Curti)
Status
26
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
http://clinicaltrials.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=1
Phase 1b Clinical Trial In Patients With Advanced
Melanoma
Using
GR-MD-02
In
Combination
With
Yervoy
®
Cohort 1 completed—no dose limiting toxicity
Cohort 2 underway (2 patients enrolled)

Patients
•
Patients
who
have
had
melanoma
progression
after
Yervoy
®
and/or
BRAF
targeted therapy in melanomas with a BRAF mutation
•
Patients
who
have
had
melanoma
progression
after
Keytruda
®
monotherapy
Design
Three patients per cohort (+3 if adverse events) with 10 patients treated with
maximum dose achieved
Dose
GR-MD-02 IV starting at dose of 1 mg/kg and escalating following each cohort
to 8 mg/kg followed by standard dose of Keytruda
®
Primary
Endpoint
Determine a safe dose of GR-MD-02 used in combination with the approved
dose of Keytruda
®
Secondary
Endpoints
•
Measure the response rate as assessed by ir-RECIST criteria
•
Assess the biological activity by measuring:
-CD4+ T cells with a memory phenotype
-CD8+ T cells with an effector phenotype
-Melanoma-specific T cells using autologous and/or HLA-matched tumor
-Examine composition of the tumor immune infiltrate from tumor biopsies
•
Assess quality of life during therapy using the FACT-M questionnaire
Trial Site
Providence-Portland Medical Center (Dr. Brendan Curti)
Status
Plan to initiate study July 2015
27
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase 1b Clinical Trial In Patients With Advanced Melanoma
Using GR-MD-02 In Combination With KEYTRUDA
®

Summary of Cancer Immunotherapy Program
•
Collaboration with investigative group at Providence Portland
Medical Center (PPMC) who have significant expertise in basic
tumor immunology and translational clinical trials
•
Pre-clinical 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 with GR-MD-02 in combination with
Yervoy (ongoing) and KEYTRUDA (planned), funded by PPMC
•
Advanced immune response markers being used to evaluate
drug effect in addition to tumor response
28
©
2015 Galectin Therapeutics  |  NASDAQ: GALT

MODERATE TO SEVERE
PLAQUE PSORIASIS
Other Potential Indications in Inflammatory Disease
29
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30
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Exploratory Phase 2a Trial In Moderate to
Severe Plaque Psoriasis
•
Patient in Phase 1 trial had apparent remission of severe psoriasis while
receiving GR-MD-02
•
Galectin-3 is increased in skin lesions of patients with psoriasis
https://clinicaltrials.gov/ct2/show/NCT02407041?term=GR-MD-02&rank=4
Primary Endpoint:
•
Evaluate the number of patients who have 75% improvement in Psoriasis Activity Severity
Index (PASI-75) following 12 weeks of therapy with GR-MD-02  
Secondary Endpoints:
•
PASI-50 and PASI-100 scores following 12 weeks of therapy with GR-MD-02
•
Determine the durability of response to therapy in responders over a one year period
following the end of therapy
•
Determine whether there is any change in disease status of patients who also have
psoriatic arthritis

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
31
Q2 2015
Product and Program Pipeline
Q2 2015
Q2 2015
7/2015
Clinical Focus
Stage of Development
Drug
Indication
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Fibrosis (monotherapy)
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
GR-MD-02
Moderate-severe
Galectin-3 Inhibitors
Discovery program to identify
subcutaneous and oral forms of
carbohydrates and oral small molecules

Study
Indication
Endpoints
Start
Data Reporting
Phase 1b:
Yervoy
®
Advanced
melanoma
Safety
ir-RECIST
Immune markers
Underway
Dose Group 1: complete
Dose Group 2: initiated,
two patients enrolled
Phase 1b:
KEYTRUDA
®
Advanced
melanoma
Safety
ir-RECIST
Immune markers
July 2015
TBD
32
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Advanced Liver Fibrosis/Cirrhosis
Advanced Melanoma
Study
Indication
Endpoints
Start
Data Reporting
GT-026
“NASH-CX”
NASH with cirrhosis
Portal pressure (HVPG);
liver biopsy
June 2015
End 2017
GT-028
“NASH-FX”
NASH with
advanced fibrosis
Multi-parametric MRI
Comparisons include
MRE and FibroScan
®
July 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)
July 2015
July 2016
Psoriasis