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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): September 12, 2014

 

 

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 8 – OTHER ITEMS

 

Item 8.01 Other Items.

On September 12, 2014, Galectin Therapeutics Inc. posted a corporate presentation on its website that contains a summary of the summary of the Company’s business, which is attached as Exhibit 99.1.

SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS

 

Item 9.01 Financial Statements and Exhibits.

(a) Financial Statements of Businesses Acquired.

Not applicable.

(b) Pro Forma Financial Information.

Not applicable.

(c) Shell Company Transactions.

Not applicable.

(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: September 12, 2014     By:  

/s/ Jack W. Callicutt

      Jack W. Callicutt
      Chief Financial Officer

 

- 3 -

EX-99.1
Corporate Presentation
September 12, 2014
NASDAQ: GALT
www.galectintherapeutics.com
©
2014 Galectin Therapeutics Inc
Exhibit 99.1

Forward-Looking Statement Disclaimer
2
©
2014 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 2014. 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.

Biopharmaceutical Company Focused On Major
Unmet Medical Needs
3
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
Organ Fibrosis
•
45%
of
US
deaths
associated
with
fibrotic
disease
1
•
Lead indication: liver fibrosis/cirrhosis due to fatty liver
disease
(75%
of
all
liver
disease
in
US)
2
•
Potentially applicable to other fibrotic diseases
•
Phase 1 clinical trial will complete in 2014; Phase 2
clinical trial starts H1 2015
Cancer
Immunotherapy
•
Focus on combination immunotherapy with GR-MD-02
•
Lead indication is advanced melanoma
•
Technology applicable to other cancers and
immunotherapies
•
Phase 1B clinical trial in progress
Drugs Target
Galectin Proteins
•
Novel complex carbohydrate drugs that block galectin-3
protein, which is involved in multiple disease processes
•
Robust efficacy in pre-clinical animal models of disease
•
Lead candidate (GR-MD-02) patent protection (Dec. 2031)
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

Pipeline
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
4
*Galectin Sciences, LLC
H1 2015
Clinical Focus
Stage of Development
Drug
Indication
Discovery
Pre-clinical
Phase 1
Phase 2
Phase 3
Fibrosis
GR-MD-02
NASH cirrhosis
Lung fibrosis
Kidney fibrosis
Cardiovascular fibrosis
Cancer Immunotherapy
GR-MD-02
Melanoma
Galectin-3 Inhibitors
GR-MD-03
Subcutaneous
GR-MD-04
Oral
G-XXX*
Oral

Function of Galectin Proteins And Drug Inhibition
5
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
Expression &
Function
•
Gal-3 widely expressed; highest in macrophages
•
Modulates cell signaling and immune cell function
•
Promote cell-cell and cell-matrix interactions
Role in Disease
•
Gal-3 expression increased in areas of inflammation
and fibrogenesis
•
Knockout of gal-3 gene in mice prevents fibrosis in
liver, lung, kidney and heart
•
The majority of cancers express high levels of gal-3
Molecular
Interactions
•
Proteins bind to galactose residues in glycoproteins
•
Promote interactions between glycoproteins
•
15 protein family; Gal-3 critical target for therapy
Drug Mechanism
•
GR-MD-02 is a complex carbohydrate with terminal
galactose residues
•
Drug binds to gal-3 and disrupts interaction with
glycoproteins

CIRRHOSIS DUE TO NASH
(NON-ALCOHOLIC STEATOHEPATITIS)
Lead Indication in Organ Fibrosis
6
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

NASH Is Epidemic And There Are
No Approved Therapies
7
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
Diabetes
Fatty Liver
NASH
US prevalence in
asymptomatic, middle-aged
adults
US
(%
of
population)
2
Obesity
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 US adults
1, 2
: > 28 million
1
Based on July 2013 US census data for people >20 years old (233,880,752)

The End Stage of Fibrosis (Cirrhosis) Is When Patients
With NASH Experience Symptoms And Complications
8
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
NASH
Complications
(variceal
bleed,
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
:      ~ 2 million
Approximately 1/3 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
1
3

GR-MD-02 Has Robust Therapeutic Effect On NASH
With Fibrosis And Cirrhosis In Rodent Models
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
9
•
GR-MD-02 decreases:
•
NASH Activity
•
Collagen (fibrosis)
•
Galectin-3 protein
1
Traber, et al. PLOS ONE 2013;8:e83481
Normal Stain
Collagen Stain
Gal-3 Stain
Mouse NASH Model
Rat Cirrhosis Model
2
Traber, et al. PLOS ONE 2013;8:e75361
Untreated
GR-MD-02
•
Cirrhosis induced by toxin and
continued with therapy
•
Four, once weekly doses of GR-MD-02
•
Marked reduction in fibrosis, thinned
broken bands (arrow)
•
Cirrhosis reversed
N=nodule
2
1
Fat
Inflammation
Ballooning

GR-MD-02 Is Being Developed For The Indication Of
Cirrhosis Due To NASH
•
Cirrhosis is late disease that is closer to adverse clinical outcomes;
cannot predict which patients with early disease will progress to
cirrhosis
•
Goal of therapy is to reverse fibrosis and cirrhosis, thereby reducing
likelihood of adverse clinical outcomes and transplantation
•
Regulatory pathway to approval better defined because potential
surrogates of clinical outcomes are more developed for late disease
•
This is an appropriate target population because GR-MD-02 treats
NASH and reduces existing fibrosis and reverses cirrhosis in pre-
clinical models
•
Majority of companies developing NASH therapies are targeting early
disease, including:
•
Intercept, Genfit, Galmed, Raptor, and others
•
Only company with phase 2 program in NASH cirrhosis is Gilead   (anti-
LOXL2 monoclonal antibody)
10
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

Phase 1 Clinical Trial Of GR-MD-02 In NASH With
Advanced Fibrosis: Fast Track FDA Designation
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
11
Biomarkers
Biomarkers
Patient:
Biopsy proven NASH with advanced fibrosis (at least stage 3)
Ascending
dose
cohort;
single
and
multiple
dose
First 2 cohorts enrolled, have at least 8 patients (6 active, 2 placebo);
Third cohort has up to 20 patients total 
Doses:
2 mg/kg, 4 mg/kg, and 8 mg/kg in the three cohorts, respectively
Primary endpoints:
Safety
Pharmacokinetics (PK)
Secondary endpoints:
Disease-related serum biomarkers to assess for
potential treatment effect
http://clinicaltrial.gov/ct2/show/NCT01899859?term=GR-MD-02&rank=2
1 week
1 week
3/4 weeks
Design
:

Primary Endpoints Were Met In Cohort 1 and 2
•
GR-MD-02 was safe and well tolerated at doses of 2 mg/kg and 4 mg/kg
•
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 up to 4 mg/kg, a dose that correlates with a
therapeutic dose in animal model of NASH.
12
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

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. (note: these biomarkers are not clinically validated as an
acceptable primary endpoint for efficacy in fibrosis treatment).
•
While the overall impression of biomarker analysis suggested there may be
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.
13
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

Next Steps: Completion of Phase 1 Trial
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
14
•
The dose of GR-MD-02 was 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 up to 20 total
patients (12 active drug and 8 placebo) which will allow comparison of a larger
number of patients.
•
Blood biomarker analysis will be conducted at four time points during the study
to account for potential sample timing differences following drug infusion.
•
Nine
(9)
patients
are
currently
enrolled
in
cohort
3
and
results
are
expected
in
November 2014.

Next Steps: Phase 2 Clinical Trial
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
15
•
Planning for phase 2 clinical trials is ongoing
•
Phase 2 trial will be initiated in H1 2015; details of the trial(s) will be
announced when planning is complete
•
The results of the first and second cohort suggest that 2 mg/kg and 4 mg/kg
are safe and well-tolerated doses, and we are now testing 8 mg/kg.
•
The doses for evaluation in Phase 2 will be chosen using the correlation of
therapeutic doses in pre-clinical animal studies and blood levels of GR-MD-02
determined
in
the
Phase
1
trial.
Biomarkers
in
Phase
1
study
are
not
integral
to choosing Phase 2 doses. 8 mg/kg dose is expected to be well within
therapeutic dose range.
•
Patient population will have cirrhosis due to NASH
•
Study endpoints and other particulars of clinical trials, including duration, are
under discussion with the FDA

Fibrosis Program Summary
•
First liver fibrosis indication: NASH with cirrhosis, a major
unmet medical need
•
Current Phase 1 trial results shows safety of four doses of 2
mg/kg and 4 mg/kg.
•
Controlled phase 2 clinical trial program to follow completion of
phase 1 trial.
•
The current results of the Phase 1 trial this defines at least two
potential dose levels for phase 2 clinical trials
•
Other Organ Fibrosis
•
Pre-clinical efficacy results in lung, kidney and cardiovascular fibrosis
•
Considering prospects for entering clinical development
•
Ongoing discussions with large pharmaceutical companies
•
Discussions
will
provide
foundation
for
partnering
opportunities
at
the
most opportune time
16
©
2014 Galectin Therapeutics  
NASDAQ:GALT

ADVANCED MELANOMA
Lead Indication in Cancer Immunotherapy
17
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

The Vast Majority of Cancers Secrete Large Amounts
of Galectins Which Have Multiple Roles In Tumor
Pathogenesis
•
Tumor cell invasion:
extracellular matrix
adhesion & detachment
•
Metastasis:
cell invasion and migration
•
Angiogenesis
•
18
©
2014 Galectin Therapeutics  
NASDAQ:GALT
Tumor immunity
has
recently been shown to be
critically affected by
galectins

Cancer Therapy Strategy
•
Focus on cancer immunotherapy based on the hypothesis that
galectin inhibitors will enhance efficacy of immunotherapies
•
Many cancers secrete large amounts of galectins & have multiple roles in
tumor pathogenesis –
importantly on tumor immunity
•
Metastatic melanoma is initial cancer indication
•
In US 76,000 new diagnoses and 9,100 deaths annually
•
Even with newly approved drugs, still a substantial unmet medical need
•
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
•
Tumor immunology basic science research
•
Ability to conduct clinical trials and assist in funding
19
©
2014 Galectin Therapeutics  
NASDAQ:GALT

Checkpoint Inhibitors Plus GR-MD-02 Boosts Anti-
Tumor Immunity, Reduces Tumor Size And Increases
Survival In Mouse Cancer Models
20
aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy, BMS)]
aPD-1 = anti-PD-1 mAb [positive results in clinical trials, BMS, 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
©
2014 Galectin Therapeutics  
NASDAQ:GALT
*p<0.05
These studies on TC-1 prostate cancer cells (also effective in breast
cancer, melanoma, and sarcoma)

Hypothesis: GR-MD-02 May Be A Complimentary Therapy To
Enhance Efficacy Of Immune Checkpoint Blockade Therapies
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
21
ICB = Immune Checkpoint Blockade

Phase 1B Clinical Trial in patients with advanced melanoma
using GR-MD-02 in combination with Yervoy®
(ipilimumab):
Actively Enrolling
22
1
23
43
64
85
Day
Infusion:
GR-MD-02
followed
by
Yervoy®
at
standard
doses
Endpoints:
Followed every 12 weeks for survival
Biopsy
Biopsy
©
2014 Galectin Therapeutics  
NASDAQ:GALT
http://clinicaltrial.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=1
Patient inclusion:
Design: 3+3 dose escalation (3 patients if no adverse events); 10 patients treated with
maximum tolerated dose
Dose: Starting dose of 1 mg/kg
Advanced
melanoma
with
indication
for
Yervoy®
treatment
Safety; Pharmacokinetics
Tumor response: immune response RECIST criteria
Biological responses including memory CD4+ T-cells, memory CD8+ T-cells, melanoma
specific T-cells, and composition of tumor immune infiltrate from tumor biopsies when
available.

Cancer Therapy Summary
•
Two immunotherapy agents have been approved for use to
date, with many more vaccines and activators in development
•
Our strategy is to leverage world class expertise in basic tumor
immunology and in the conduct of melanoma clinical trials.
•
Providence Portland Medical Center and Earle A. Chiles
Research
Institute
(EACRI)
accepted for  phase 1B clinical trial in patients with advanced
melanoma treated with a combination of Yervoy and GR-MD-02
•
Initial funding of clinical trial by PPMC/EACRI. Galectin is providing
GR-MD-02 study drug, reference to its IND, and PK analysis
•
Ongoing discussions with large pharmaceutical companies in
the immunotherapy space to seek a partnering opportunity at
the most opportune time
23
©
2014 Galectin Therapeutics  
NASDAQ:GALT
Ongoing pre-clinical studies; IND
:

Milestones
24
©
2014 Galectin Therapeutics  |  NASDAQ:GALT
Compound
Program
Milestone
Timing
GR-MD-02
NASH Cirrhosis
Complete Phase 1 Trial
End 2014
Start Phase 2 Trial
H1 2015
Phase 2 Results
TBD
GR-MD-02
Melanoma
Complete Phase 1B Trial
End 2015

Key Executive Officers
•
Peter G. Traber, MD –
CEO & CMO
•
President & CEO of Baylor College of Medicine
•
Sr. VP
Clinical
Development
and
CMO
–
GlaxoSmithKline
plc
•
Chairman & CEO of TerraSep, LLC
•
President & CEO of University of Pennsylvania Health System,
•
Chair of Internal Medicine and Chief of Gastroenterology, University of Pennsylvania School of Medicine
•
James Czirr, Exec. Chairman
•
Cofounder of 10X Fund and Managing Member
•
Cofounder of GalectinTherapeutics
•
CEO of Minerva Biotechnologies Corp.
•
Harold H. Shlevin, PhD –
COO & Corporate Secretary
•
Principle/Manager of Bioscience Commercialization
–
Georgia Institute of Technology
•
VP
Operations
&
Commercial
Development
–
Altea
Therapeutics
Inc.
•
President & CEO –
Tikvah Therapeutics
•
President & CEO –
Solvay Pharmaceuticals
•
Cofounder and Sr VP –
Ciba Vision Ophthalmics
•
Jack W. Callicutt –
CFO & Corporate Treasurer
•
CFO of Reach Health, Inc.
•
CFO of Vystar Corporation
•
CFO of IVOX, Inc., Tikvah Therapeutics & Corautus Genetics
•
Deloitte
25
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

Key Employees/Consultants
•
J. Rex Horton –
Executive Director of Regulatory Affairs and Quality
Assurance
•
Director
of
Regulatory
Affairs
–
Chelsea
Therapeutics
•
Director
of
Regulatory
Affairs
–
Solvay
Pharmaceuticals,
Inc.
•
Eliezer Zomer, PhD –
Manufacturing and Product Development Head
•
Executive
VP
of
Manufacturing
&
Product
Development
–
Galectin
Therapeutics
•
Founder of Alicon Biological Control
•
VP
of
Product
Development
-
Safe
Sciences,
Inc.
•
VP of R&D –
Charm Sciences, Inc.
•
Elena Chekova, PhD –
Program Manager
•
Director
of
Business
Development
&
Project
Management
–
Pro-Pharmaceuticals
•
Founder
and
CEO
-
Biotine
Consulting
•
VP
of
Business
Development
–
Chiral
Quest
•
Analyst
–
McKinsey
&
Berteslmann
AG
26
©
2014 Galectin Therapeutics  |  NASDAQ:GALT

Financial
Key
Facts
–
As
of
September
8,
2014
27
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
$5.81        $4.28
-
$19.11
Shares Outstanding
22 million
Daily Volume (3-month average)
733,000 shares
Market Capitalization
$128 million
Debt
$0
Cash & Equivalents (June 30, 2014)
$34.4 million
Estimated Spending in 2014
$14 million
©
2014 Galectin Therapeutics  
NASDAQ:GALT