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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): January 7, 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 January 7, 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, 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: January 7, 2015     By:  

/s/ Jack W. Callicutt

      Jack W. Callicutt
      Chief Financial Officer

 

- 3 -

EX-99.1
Corporate Presentation
January 7, 2015
NASDAQ: GALT
www.galectintherapeutics.com
©
2015 Galectin Therapeutics Inc.
Exhibit 99.1

2
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
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. 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,
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.

3
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Organ Fibrosis
•
45% of U.S. deaths are associated with fibrotic disease
•
Lead indication is liver fibrosis/cirrhosis due to fatty liver
disease (75% of all liver disease in U.S.)
•
Potentially applicable to other fibrotic diseases
•
Phase 1 clinical trial completed
•
Phase 2 clinical trials to start Q2 2015
Cancer
Immunotherapy
•
Focus on combination immunotherapy, one of the most
prominent approaches to cancer therapy
•
Lead indication is advanced melanoma
•
Technology applicable to other cancers
•
Phase 1b clinical trial in progress
•
Second trial to start Q2 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
2
1

4
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Strong Intellectual
Property
•
Multiple composition-of-matter patents and method patents
Knowledge
•
Expertise with complex carbohydrate drugs that promote galectin-3
inhibition, with applicability to large patient populations
•
Initial focus on the treatment of NASH with advanced fibrosis, with
encouraging data in early human trials and preclinical data showing
potential for reversal of disease
Investment Highlights
NASH with
Advanced Fibrosis
•
Lead compound, GR-MD-02, directed to a potential cirrhosis and
advanced fibrosis market, currently approximately 6 million people in
the U.S. and growing
Large Market &
Unmet Need
Melanoma
Experienced Team
Defined Regulatory
Pathway
•
GR-MD-02 is also being studied in advanced melanoma in combination
with two different cancer immunotherapeutic agents
Potential Partnering
•
Multiple near-term clinical and regulatory milestones and potential for
Phase 2 program under an SPA, which may include a registration trial
•
A product pipeline that may be attractive to licensing agreements with
large pharmaceutical companies
•
An accomplished management team with significant large pharma and
entrepreneurial experience

5
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Role in Disease
•
Gal-3 is increased in inflammation and fibrogenesis
•
Elimination of gal-3 in mice 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
•
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 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

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
6
*Galectin Sciences, LLC
Deep Product Pipeline
Q2 2015
Clinical Focus
Stage of Development
Drug
Indication
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
Fibrosis (monotherapy)
GR-MD-02
NASH cirrhosis
Lung fibrosis
Kidney fibrosis
Cardiovascular fibrosis
Cancer Immunotherapy (combination therapy)
GR-MD-02
Melanoma
Galectin-3 Inhibitors
GR-MD-03
Subcutaneous
GR-MD-04
GM-CT-04
Oral
G-XXX*
Oral

ADVANCED FIBROSIS AND
CIRRHOSIS DUE TO NASH
(NON-ALCOHOLIC STEATOHEPATITIS)
Lead Indication in Organ Fibrosis
7
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

8
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
U.S. Prevalence in
Asymptomatic, Middle-Aged
Adults (% of population)
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 U.S. adults
1, 2
> 28 million
1
Based on July 2013 US census data for people >20 years old (233,880,752)
Obesity
Diabetes
Fatty Liver
NASH
NASH: An Epidemic With No Approved Therapies
2

9
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
NASH
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
Asymptomatic
Estimated prevalence of advanced fibrosis
1,2
:         ~ 6 million
Estimated prevalence of cirrhosis
:      ~ 1-2 million
Approximately one-third 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
End-Stage Fibrosis (Cirrhosis) Is When Patients With
NASH Experience Symptoms And Complications
1
3

10
Normal
NASH: Control
NASH: GR-MD-02
GR-MD-02 Effects
NAFLD Activity Score
Fat
Cell death
Inflammation
Collagen
(Fibrosis)
Collagen Stain
Cellular Stain
*Traber PG and Zomer E. Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors. PLOS ONE 2013;8:e83481
Galectin-3
Protein
Galectin-3 Stain
GR-MD-02 reduces Gal-3, which results in reduction in
liver inflammation and fibrosis
Robust Preclinical Data: GR-MD-02 Has Therapeutic
Effect On NASH With Fibrosis In Mouse Model*

11
Vehicle-Treated
GR-MD-02-Treated
(90 mg/kg, 1/W x 4)
*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.
N=10
N=10
N=10
Robust
Preclinical
Data:
GR-MD-02
Reversed
Cirrhosis
And Improved Portal Hypertension In Rat Model*
N=10
N=10
Portal Pressure
Collagen

•
Safety
•
GR-MD-02 was safe and well tolerated after IV administration of four doses of
2 mg/kg, 4 mg/kg and 8mg/kg lean body weight
•
Drug Levels
•
Pharmacokinetics
revealed
drug
exposure
in
humans
at
the
8
mg/kg
dose
that was equivalent to the upper range of the targeted therapeutic dose
determined from effective doses in NASH animal models
•
Disease Serum Marker Effect
•
There
was
a
statistically
significant,
dose-dependent
reduction
in
FibroTest
®
scores due to a statistically significant reduction in alpha-2 macroglobulin
serum levels
•
Liver Stiffness Effect
•
There was a signal of reduced liver stiffness in patients receiving GR-MD-02
as
measured
by
FibroScan
®
12
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
See Appendix for additional detailed Phase 1 results
Successful Phase 1 Clinical Trial In NASH Patients
With Advanced Fibrosis Met Key Endpoints

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
ns³
ns
4
Legend and Notes:
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Highly
Significant
Reduction
In
Alpha-2
Macroglobulin
(A2M) Serum Levels Seen At The 8 mg/kg Dose
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)

•
FibroTest
®
is a composite fibrosis score that is calculated from serum A2M
levels
and four other tests, including GGTP, total bilirubin, haptoglobin and
apolipoprotein A1
•
FibroTest
®
has been shown to correlate with stage of fibrosis, changes with
fibrosis regression and progression, and may predict liver-related mortality*
•
A reduction in FibroTest
®
would suggest an improvement in liver fibrosis
•
In this acute setting, following four doses of 8 mg/kg GR-MD-02, the reduction in
FibroTest
®
is due entirely to reduced serum levels of A2M
•
A2M is a relevant marker for liver fibrosis because it is known to:
•
Inhibit proteases such as collagenase, which may promote fibrosis
•
Is increased in fibrogenic stellate cells in liver fibrosis
•
Serum levels have been shown to correlate with liver fibrosis
•
The reduction seen in A2M does not necessarily mean fibrosis got better in this
short study, but does suggest changes in the fibrogenic process that might lead
to an improvement in fibrosis with longer-term therapy
14
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Reduction In A2M Is Encouraging For GR-MD-02
Effect On Liver Fibrosis
*Ratziu, et al. BMC Gastro, 2006; Poynard, et al. BMC Gastro, 2007; Poynard, et al. J. Hepatology, 2012; Poynard, et al. J. Hepatology, 2013

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
15
•
FibroScan uses an
electromechanical vibrator and
pulse-echo ultrasound to evaluate
the elastic shear wave in liver
tissue
•
The volume of liver tissue
assessed is ~100-times greater
than volume assessed by liver
biopsy
•
The stiffness of the liver is
recorded as the pressure
measurement of kiloPascals
•
The stiffness of the liver
correlates with the degree of liver
fibrosis as assessed by liver
biopsy
•
FibroScan represents a promising
non-invasive, out-patient method
for measuring changes in liver
fibrosis over time
FibroScan
®
Is A Non-Invasive, Ultrasound-Based
Method For Assessing Liver Stiffness, Which
Correlates With Liver Fibrosis

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
16
Placebo
GR-MD-02 (8 mg/kg)
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
80%
100%
150
100
50
0
150
100
50
0
Day -1
Day 38
Day 63
Day -1
Day 38
Day 63
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).
®

GR-MD-02 at doses up to 8 mg/kg IV is safe and well tolerated in
NASH patients with advanced fibrosis
A dose of 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
In conclusion, these results provide a firm foundation for entry
into a Phase 2 development program
17
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Conclusions From Results Of Phase 1 Trial In NASH
Patients With Advanced Fibrosis

•
Multiple, concurrent Phase 2 clinical trials will be conducted
•
Two indications in patients with NASH will be evaluated
•
Cirrhosis with portal hypertension
•
Advanced fibrosis as indicated by liver stiffness
•
Multiple
modalities
for
the
assessment
of
liver
fibrosis
will
be
used
in the trials, depending on the design
•
Hepatic venous wedge pressure (measure portal pressure)
•
Liver biopsy (assess degree of liver fibrosis)
•
FibroScan (assess liver stiffness)
•
Magnetic resonance elastography (assess liver stiffness)
•
Multi-parametric magnetic resonance imaging (LiverMultiScan) (assess liver
inflammation and fibrosis)
•
C-methacetin
breath
test
(assess
liver
metabolism)
•
Trial design and timetables will be presented in February 2015 and
trials will commence in the second quarter of 2015
18
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Goals of the Phase 2 Development Program
13

ADVANCED MELANOMA
Lead Indication in Cancer Immunotherapy
19
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

•
Tumor cell invasion:
extracellular matrix
adhesion and detachment
•
Metastasis:
cell invasion and migration
•
Angiogenesis
•
Tumor immunity has
recently been shown to be
critically affected by
galectins
20
The Vast Majority of Cancers Secrete Large Amounts
of Galectins, Which Have Multiple Roles In Tumor
Pathogenesis
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

21
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Advanced
Melanoma as
Initial Indication
•
In U.S. 76,000 new diagnoses and 9,100 deaths*
•
Even with newly approved drugs, a substantial
unmet medical need remains
Focus on
Immunotherapy
•
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
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 and
tumor immunology basic science research
•
Ability to conduct clinical trials and assist in funding
Cancer Therapy Strategy
*Siegel, et al. CA Cancer J Clin 2012;62:10

22
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

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
23
CTLA-blockade
(Yervoy
®
)
PD-1-blockade
(Keytruda
®
)
Hypothetical:
Immune checkpoint blockade
Plus GR-MD-02
Hypothesis: GR-MD-02 May Be A Complementary
Therapy To Enhance Efficacy Of Immune Checkpoint
Blockade Therapies
1
2
3
4
Years

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
®
1
endpoint
Determine a safe dose of GR-MD-02 used in combination with the approved dose
of
Yervoy
®
2
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
Actively recruiting: Three patients enrolled in cohort 1, one drop out
24
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
http://clinicaltrial.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
®

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
®
1
endpoint
Determine a safe dose of GR-MD-02 used in combination with the approved dose of
Keytruda
®
2
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 Q2 2015
25
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase 1b Clinical Trial In Patients With Advanced
Melanoma
Using
GR-MD-02
In
Combination
With
Keytruda
®

26
Experienced Leadership Team
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
James
Czirr, Executive
Chairman
Peter G. Traber, M.D.
President, CEO, CMO
Harold H. Shlevin, Ph.D.
COO & Corporate
Secretary
Jack W. Callicutt
CFO
Eliezer Zomer, Ph.D.
Pharmaceutical
Development
J. Rex Horton
Executive Director,
Regulatory Affairs and
Quality Assurance
Manager and general partner of 10X Fund, L.P., Co-Founder, Pro-Pharmaceuticals,
CEO, Minerva Biotechnologies Corporation
Over 28 years experience in biomedicine and pharmaceutical industries in research
and development, clinical medicine and business development.
GlaxoSmithKline (CMO), Un of Pennsylvania (CEO, Chief of GI, Chairman of
Medicine), Baylor College of Medicine (CEO)
Over 32 years of senior experience in the development and commercialization
of pharmaceuticals and business development including mergers and acquisitions.
Solvay Pharmaceuticals (CEO), CIBA Vision Ophthalmics  (n/k/a Novartis Vision)
(SVP & co-founder), Tikvah Therapeutics (Founder, CEO)
Over 24 years in accounting and finance with life science and technology
companies
with
significant
experience
in
negotiating
and
closing
financing
transactions.
CFO Reach Health, CFO of Vystar Corporation, CFO Corautus Genetics, Deloitte
Over 30 years
experience in biotechnology engineering  and regulatory in
pharmaceuticals and
diagnostics.
Koor Biotechnologies, Charm Sciences, Glycogenesis, HU Medical School
(Jerusalem), Harvard University
Over 24 years of experience working in the biotech and life sciences
industries, regulatory affairs and manufacturing.
Director Regulatory Affairs at Solvay Pharmaceuticals and Chelsea Therapeutics,
Georgia Institute of Technology.

Study
Indication
Endpoints
Start
Data Reporting
Phase 1b:
Yervoy
®
Advanced
melanoma
Safety
ir-RECIST
Immune markers
Underway
Cohort 1:  1H 2015
Phase 1b:
Keytruda
®
Advanced
melanoma
Safety
ir-RECIST
Immune markers
Q2 2015
TBD
27
©
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)
Q2 2015
The full trial design
and the expected
timings for top-line
results will be outlined
in detail in February
2015.
GT-027
“NASH-FX”
NASH with
advanced fibrosis
Liver stiffness
(FibroScan
®
)
Q2 2015
GT-028
“NASH-DX”
NASH with
advanced fibrosis
Liver stiffness
(magnetic resonance
elastography)
Q2 2015
Development Program Milestones

APPENDIX
28
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2015 Galectin Therapeutics  |  NASDAQ:GALT

A Multi-Center, Partially Blinded, Maximum Tolerated Multiple Dose
Escalation, Phase 1 Clinical Trial to Evaluate the Safety of
GR-MD-02 in Subjects with Non-Alcoholic Steatohepatitis (NASH)
with Advanced Hepatic Fibrosis
•
Overall Objective:
•
Evaluate safety and pharmacokinetics of GR-MD-02 to provide
information and support to design a Phase 2 clinical program to
assess efficacy of GR-MD-02 in patients with NASH with advanced
fibrosis and cirrhosis. 
•
Clinical trial sites
•
Brooke Army Medical Center, Fort Sam Houston, TX
•
Indiana University School of Medicine, Indianapolis, IN
•
The Texas Liver Institute, San Antonio, TX
•
University of Southern California, Los Angeles, CA
•
VCU Medical Center, Richmond, VA
•
Icahn School of Medicine at Mount Sinai, New York, NY
•
St. Louis University, St. Louis, MO
29
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

•
Subjects:
Biopsy
proven
NASH
with
Brunt
Stage
3
fibrosis
•
Design:
•
Blinded, placebo controlled, sequential dose escalation
•
Three cohorts: Four doses over 6-7 weeks of 2, 4, and 8 mg/kg
lean body weight administered by IV infusion over one hour
•
Primary
Endpoints:
Safety
and
Pharmacokinetics
•
Exploratory
Endpoints:
Potential
serum
biomarkers
30
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
3-Cohort Design Of Phase 1 Clinical Trial
The red triangles indicate timing of blood draws for assessment of exploratory biomarkers and the blue triangles indicate timing of
FibroScan assessment. After the last infusion, biomarkers assessed at 3 days and 14 days after infusion and FibroScan at 3 days and
28 days after infusion.

Cohort 1
(2 mg/kg)
Cohort 2
(4 mg/kg)
Cohort 3
(8 mg/kg)
Enrolled
8
10
13
Completed
8
9
13
Completed Patients
Age Range (Mean)
40-64 (54)
34-69 (52)
31-69 (57)
Sex (M/F)
2/6
6/4
6/7
BMI (Mean)
39
40
36
BMI
30
8
9
8
Diabetes
6
4
6
31
Phase 1 Trial:
Patient Characteristics
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

32
Cohort 1
(2 mg/kg)
Cohort 2
(4 mg/kg)
Cohort 3
(8 mg/kg)
Active
Placebo
Active
Placebo
Active
Placebo
Completed protocol
6
2
7
2
7
6
Serious Adverse Events
0
0
0
0
0
0
TEAE’s probably related
0
0
0
0
0
0
TEAE’s possibly related
0
2
2
0
0
2
•
Therapy Emergent Adverse Events, possibly related to study drug were
reported in 4 subjects who received placebo and 2 subjects who received
GR-MD-02.  All adverse events were mild (grade 1) and transient.
•
An independent Data Safety Monitoring Board (DSMB) reviewed all data
after first and second cohorts.
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase 1 Trial:
Safety Data

33
•
Proportional increase in drug coverage (AUC) for 2 mg/kg, 4 mg/kg,
and first dose of 8 mg/kg
•
Increase in AUC after four doses of 8 mg/kg indicates a saturable
compartment model
Cmax
µg/mL
T1/2
H
AUC
µg*h/mL
2 mg/kg x1
16.3
19.9
573
2 mg/kg x4
17.7
20.5
645
4 mg/kg x1
30
19.8
1039
4 mg/kg x4
31
19.5
1075
8 mg/kg x1
99.5
18.2
2449
8 mg/kg x4
169.9
18.4
4909
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Mean GR-MD-02 Plasma Concentration-Time Profiles
After First And Fourth Doses In All 3 Cohorts

34
Target
Therapeutic
Window
•
The best therapeutic dose in mouse NASH was between 10 and 30 mg/kg
•
Relationship between AUC and dose shows mouse and human equivalency
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Pharmacokinetics Indicates 8 mg/kg Dose Is Within
The Upper Range Of The Targeted Therapeutic Window
AUC of Human 8 mg/kg dose
AUC of Human 2 mg/kg dose

35
p < 0.05
5
p < 0.01
5
ns
5
2    dose
4   dose
+ 14 da
4   dose
+ 3 da
Cohort 3
4    dose
+ 14 da
Cohort 1
4    dose
+ 3 da
Cohort 2
ns³
ns
4
Legend and Notes:
A
Significant
Reduction
In
FibroTest
®
Scores Were
Seen At The 8 mg/kg Dose
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
FibroTest
®
scores are calculated from age, gender, alpha-2-macroglobulin, haptoglobin,
apolipoprotein A1, gamma-glutamyl transpeptidase (GGT), and total bilirubin
Mean ±
Standard Deviation
Placebo values (change from
baseline) were combined for all
three cohorts because there were
no differences (n=19)
Not significant versus placebo,
two-sided t-test (n=6)
Not significant versus placebo,
two-sided t-test (n=7)
Significant for three groups
versus placebo, ANOVA with
Dunnett’s test for multiple
comparisons (n=7)
5.
1.
2.
3.
4.
th
th
th
th
nd

36
p < 0.005
5
p < 0.001
5
p < 0.05
5
Cohort 3
8 mg/kg
Cohort 1
2 mg/kg
Cohort 2
4 mg/kg
ns³
ns
4
©
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
®
4
th
dose
+ 14 da
4
th
dose
+ 3 da
2
nd
dose
4
th
dose
+ 14 da
4
th
dose
+ 3 da
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)

Existing Patent Position Supporting Fibrosis Program
Using GR-MD-02
Patent
Title
Priority
Issued
International
US 8,236,780
Galactose-pronged polysaccharides in a
formulation for anti-fibrotic therapies
5/16/2006
8/7/2012
None
US 8,658,787
Galacto-rhamnogalacturonate compositions for the
treatment of non-alcoholic steatohepatitis and non-
alcoholic fatty liver disease
9/16/2011
2/25/2014
Pending
US 8,722,645
Galactose-pronged polysaccharides in a
formulation for anti-fibrotic therapies
5/16/2006
5/13/2014
None
US 8,828,971
Galactose-Pronged Carbohydrate Compounds for
the Treatment of Diabetic Nephropathy and
Associated Disorders
10/2011
9/9/2014
Pending
US 8,871,925
Composition of Novel Carbohydrate Drug for
Treatment of Human Diseases
12/28/2011
10/28/2014
Pending
US 14/456,644
Composition of Novel Carbohydrate Drug for
Treatment of Human Diseases
12/28/2011
10/15/2014
(NOA)
Pending
37
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
•
Method of use patents for GR-MD-02 are pending in cancer Immunotherapy,
diseases related to inducible nitric oxide (iNOS) activity, and lung fibrosis
•
Company also has multiple composition and method patents for GM-CT-01,
another inhibitor not currently in clinical trials

38
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
$3.47       $3.00
-
$19.11
Shares Outstanding
22.3 million
Daily Volume (3-month average)
154,000 shares
Market Capitalization
$89 million
Debt
$0
Cash & Equivalents
$29.1 million
Estimated Spending in 2015
$20 million
Financial
Key
Facts
–
As
Of
December
31,
2014
©
2015 Galectin Therapeutics  |  NASDAQ:GALT