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): February 24, 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 February 24, 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: February 24, 2015 By: /s/ Jack W. Callicutt
Jack W. Callicutt
Chief Financial Officer

 

- 3 -



Corporate Presentation
February 24, 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,
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.
Forward-Looking Statements

3
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
•
45%
of
U.S.
deaths
are
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
•
Phase 1 clinical trial completed
•
Phase 2 clinical trials to start Q2 2015
•
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
Cancer
Immunotherapy
Organ Fibrosis

4
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
•
Multiple composition-of-matter patents and method patents
•
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
•
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
•
GR-MD-02 is also being studied in advanced melanoma in combination
with two different cancer immunotherapeutic agents
•
Multiple mid-term clinical and regulatory milestones and potential for
Phase 2 program under an SPA for 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
Knowledge
Strong Intellectual
Property
NASH with
Advanced Fibrosis
Large Market &
Unmet Need
Defined Regulatory
Pathway
Melanoma
Potential Partnering
Experienced Team

5
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
•
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
•
Binds to galactose residues in glycoproteins and promotes
interactions
•
High expression in immune cells (macrophages)
•
Modulates cell signaling and immune cell function
•
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
Galectin-3 Protein
Function
Role in Disease
Lead Drug
Candidate
GR-MD-02

©
2015 Galectin Therapeutics  |  NASDAQ:GALT
6
*Galectin Sciences, LLC
Deep Product Pipeline

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)
2
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

9
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Complications
(variceal
bleeding,
ascites,
encephalopathy)
Liver Transplantation (projected to be leading reason)
Liver-Related Death
Estimated prevalence of advanced fibrosis
1,2
:         ~ 6 million
Estimated 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

10
*Traber PG and Zomer E. Therapy of Experimental NASH and Fibrosis with Galectin Inhibitors. PLOS ONE 2013;8:e83481
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
*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.
Robust
Preclinical
Data:
GR-MD-02
Reversed
Cirrhosis
And Improved Portal Hypertension In Rat Model*

•
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
•
https://clinicaltrials.gov/ct2/show/NCT01899859?term=GR-MD-02&rank=2
•
Primary Endpoints:
Safety and Pharmacokinetics
•
Exploratory
Endpoints:
Potential
serum
biomarkers,
FibroScan
®
12
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.
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase 1 Clinical Trial (GT-020): Completed
December 2014

13
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
SUSAR (Suspected
unexpected serious
adverse reactions)
0
0
0
0
0
0
Serious Adverse Events
0
0
1*
0
0
0
TEAE’s probably related
0
0
0
0
0
0
TEAE’s possibly related **
0
2
2
0
0
2
*The female partner of one male patient in cohort 2 had a spontaneous abortion following the study. Conception was
predicted to be more than 30 days past last infusion. The Principal Investigator determined that this event was
unrelated to study drug and the DSMB concurred.
**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
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase
1
Trial:
GR-MD-02 Was Found To Be Safe And
Well Tolerated

14
•
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

15
A
Significant
Reduction
In
FibroTest
®
Scores
Were
Seen At The 8 mg/kg Dose
FibroTest
®
scores are calculated from age, gender, alpha-2-macroglobulin, haptoglobin,
apolipoprotein A1, gamma-glutamyl transpeptidase (GGT), and total bilirubin
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Legend and Notes:
1.
Mean ±
Standard Deviation
2.
Placebo values (change from
baseline) were combined for
all three cohorts because there
were no differences (n=19)
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)

16
©
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
®
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
17
•
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
18
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).

•
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 an end-of-phase 1 meeting, the FDA provided feedback on
Phase 2 program and advice on most relevant trial endpoints.
•
FDA agreed to review a potentially pivotal Phase 2 trial under a
Special Protocol Assessment
19
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Results
Of
Phase
1
Trial
Provide
Firm
Foundation
For
Entry Into A Phase 2 Development Program

Phase 2 NASH Clinical Development Program
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
20
1 Year of
Therapy
Patient
Population
Cirrhosis due
to NASH
Objective
Expectation From
Successful Study
Reduction of portal
pressure as a result
of reversing fibrosis
Could serve as a 
pivotal trial for
marketing approval
NASH-CX
4 Months of
Therapy
Reduction of liver
stiffness as a result
of reversing fibrosis
and comparison of
non-invasive
assessments
Could serve as basis
for P2b and P3 trials
NASH-FX
NASH with
Advanced
Fibrosis

Patients
Portal hypertension with NASH cirrhosis
Design
•
Randomized, controlled, blinded, multicenter trial
•
Three groups of 52 subjects for a total of 156 subjects
Dose &
Duration
•
Placebo and two doses of GR-MD-02 (2 mg/kg and 8 mg/kg)
•
Randomized 1:1:1
•
52 week treatment period with drug administration every other week for a
total of 26 doses
Primary
endpoint
Evaluate the efficacy of GR-MD-02 on reducing hepatic venous pressure
gradient (HVPG) as a measure of portal pressure compared to placebo at 1
year of treatment
Secondary
endpoints
•
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
Trial Sites
45-60 in US and Canada (Contract Research Organization is PPD)
Expected
Milestones
First Patent Screened: May 2015
Last Patient Enrolled: July 2016
Last Patient, Last Visit: Aug 2017
Top Line Data: Q4 2017
21
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
The NASH-CX Trial (GT-026)

Complications of Portal Hypertension in Cirrhosis
(Portal Hypertension = High Blood Pressure in Portal Vein)
©
2015 Galectin Therapeutics  |  NASDAQ: GALT
The Goal is to:

Assessment Methods for Liver Fibrosis in
NASH-CX Trial
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
23

Key Points of NASH-CX Clinical Trial
•
FDA in agreement with endpoint of HVPG
•
Reduction in HVPG is reasonably likely to predict clinical
benefit and therefore can be considered a surrogate
marker for clinical outcome
•
FDA has agreed to review protocol under Special Protocol
Assessment
•
Trial could serve as a pivotal trial for approval
•
The endpoint of HVPG will be evaluated for correlation
with liver biopsy and non-invasive measures of the liver
which may be used in future studies
24
©
2015 Galectin Therapeutics  |  NASDAQ: GALT

Patients
NASH with advanced fibrosis (>Brunt stage 3 fibrosis)
Design
•
Randomized, controlled, blinded, single center trial
•
Two groups for a total of 30 subjects
Dose &
Duration
•
Placebo and 8 mg/kg GR-MD-02
•
Randomized 1:2
•
16 week treatment period with drug administration every other week for a
total of 9 doses
Primary
Endpoint
Evaluate the efficacy of GR-MD-02 on reducing liver fibrosis as assessed by
MR-elastography
Secondary
Endpoints
•
FibroScan
®
Score
•
Multi-parametric
magnetic
resonance
imaging
(LiverMultiScan
®
)
Trial Site
Brooke Army Medical Center (Dr. Stephen Harrison)
Expected
Milestones
First Patent Enrolled: June 2015
Top Line Data: June 2016
25
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
The NASH-FX Trial (GT-028)

Non-Invasive Assessments of Liver Fibrosis in
NASH-FX trial
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
26
Transient Elastography
(FibroScan™)
MR-Elastography
LiverMultiScan*
*Perspectum Diagnostics™
Whole liver assessment of
stiffness using magnetic
resonance imaging with
mechanical pulse
Whole liver assessment of
fibrosis using multi-
parametric magnetic
resonance imaging
Regional assessment of
liver for tissue stiffness
(FDA approved)
Echosense™

Key Points of NASH-FX Clinical Trial
•
Different population of patients than NASH-CX trial with
advanced fibrosis, but not necessarily cirrhosis
•
Shorter term treatment than NASH-CX trial
•
Evaluation of three promising non-invasive tests for
assessment of liver fibrosis
•
A positive study might be supportive of a clinical effect
which could be used in a Breakthrough Designation
application to the FDA
27
©
2015 Galectin Therapeutics  |  NASDAQ: GALT

ADVANCED MELANOMA
Lead Indication in Cancer Immunotherapy
28
©
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
29
The Vast Majority of Cancers Secrete Large Amounts
of Galectins, Which Have Multiple Roles In Tumor
Pathogenesis
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

30
Potential sites of action for galectin inhibition in
tumor immunology
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”
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

31
©
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
Cancer Therapy Strategy
*Siegel, et al. CA Cancer J Clin 2012;62:10

32
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
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
33
Hypothesis: GR-MD-02 May Be A Complementary
Therapy To Enhance Efficacy Of Immune Checkpoint
Blockade Therapies
Note:
these
are
illustrative
curves
not
representative
of
actual
data;
redrawn
from figure of the American Association for Cancer Research, 2013

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
Cohort 1 completed—no dose limiting toxicity
Cohort 2 underway
34
©
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
®

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 Q2 2015
35
©
2015 Galectin Therapeutics  |  NASDAQ:GALT
Phase 1b Clinical Trial In Patients With Advanced
Melanoma
Using
GR-MD-02
In
Combination
With
Keytruda
®

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
Phase 1b:
Keytruda
®
Advanced
melanoma
Safety
ir-RECIST
Immune markers
Q2 2015
TBD
36
©
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
Q4 2017
GT-028
“NASH-FX”
NASH with
advanced fibrosis
Liver stiffness
(magnetic resonance
elastography); 
comparisons include
FibroScan
®
and
multi-
parametric MRI
Q2 2015
Q2 2016
Expected Development Program Milestones

37
Experienced Leadership Team
©
2015 Galectin Therapeutics  |  NASDAQ:GALT

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
Galectin Therapeutics (NASDAQ:GALT)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Galectin Therapeutics Charts.
Galectin Therapeutics (NASDAQ:GALT)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Galectin Therapeutics Charts.