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
February 14, 2012
Date of Report (Date of earliest event reported)
GALECTIN THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
| NEVADA | 000-32877 | 04-3562325 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
7 WELLS AVENUE
NEWTON, MASSACHUSETTS
02459
(Address of Principal Executive Offices) (Zip Code)
(617) 559-0033
(Registrant’s telephone number, including area code)
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)) |
| Item 7.01. | Regulation FD Disclosure. |
Peter G. Traber, M.D., President and Chief Executive Officer of Galectin Therapeutics, Inc. (“Company”), is presenting a corporate update at the BIOCEO & Investor Conference on February 14, 2012 contained in the slide presentation attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).
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.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Corporate Update Presentation Slides - dated February 14, 2012. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GALECTIN THERAPEUTICS, INC. | ||
| By: | /s/ Anthony Squeglia | |
| Anthony Squeglia | ||
| Chief Financial Officer | ||
Date: February 14, 2012
Exhibit Index
| Exhibit Number |
||
| 99.1 | Corporate Update Presentation Slides dated February 14, 2012. | |
 Corporate Summary
February 2012
OTC: GALT
Exhibit 99.1 |
 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. Factors that could
cause our actual performance to differ materially from those discussed in
the forward-looking statements include, among others: incurrence of
operating losses since our inception, uncertainty as to adequate financing
of our operations, extensive and costly regulatory oversight that could
restrict or prevent product commercialization, inability to achieve commercial
product acceptance, inability to protect our intellectual property,
dependence on strategic partnerships, product competition, and others stated
in risk factors contained in our SEC filings. We cannot assure that we have
identified all risks or that others may emerge which we do not anticipate.
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.
©
2012 Galectin Therapeutics
OTC:GALT
2 |
 HIGHLIGHTS
Proprietary
Compounds
•
First in class, proprietary compounds that inhibit galectin proteins
•
Novel class of safe, complex carbohydrate drugs
•
GR-MD-02: Non-alcoholic steatohepatitis (NASH) and other causes of
liver fibrosis (clinical Q1 2013)
•
GM-CT-01: Enhance immune cell killing of cancer cells (Phase I/II)
Validated Science
•
Pre-clinical models demonstrate that galectins are critical targets for
intended diseases and mechanisms that would be novel in the market
Large Market
Opportunities
•
NASH
and
liver
fibrosis
indications
would
be
first
therapies
for
completely
unmet medical needs, representing a multi-billion dollar market
•
Enhanced
immune
killing
of
cancer
cells
is
synergistic
with
many
current
and experimental therapies, expected to be a $7 billion market by 2015
Intellectual Property
•
Control 100% of commercial rights
•
GR-MD-02: Matter and Methods pending (priorities of 2006-2011)
•
GM-CT-01: Matter and Methods granted (expire 2023, priority 2003)
Experienced
Management Team
•
Management team has collective experience in multiple biotechnology
and large Pharma companies and relevant scientific areas
©
2012 Galectin Therapeutics
OTC:GALT
3 |
 Experienced Management Team
©
2012 Galectin Therapeutics
OTC:GALT
4
Peter G. Traber, MD
President, CEO, CMO
•
Over 25 years experience in biomedicine and pharmaceutical industries in research
and development, clinical medicine, management and leadership, and business
development. Medical expertise in liver disease
•
GlaxoSmithKline, University of Pennsylvania, Baylor College of Medicine
Anatole Klyosov, PhD
Chief Scientist
•
Over 35 years experience in biochemical reactions and their mechanisms,
biotechnology, and carbohydrate research
•
Moscow University, Russian Academy of Sciences, Harvard Medical
School
Eliezer Zomer, PhD
EVP, Product
Development
•
Over 30 years
experience in biotechnology engineering and regulatory
in
pharmaceuticals and
diagnostics.
•
Koor Biotechnologies, Charm Sciences, Glycogenesis, HU Medical School
(Jerusalem), Harvard University
Anthony Squeglia, MBA
CFO
•
Over 25 years in finance, strategic planning, marketing & investor relations
with technology companies
•
ITT,
ATT,
Ascom
Timeplex,
Quentra
Networks.
BBA
from
The
Wharton
School,
University of Pennsylvania; MBA from Pepperdine University
Maureen Foley
COO
•
Over 30 years experience in business and operations management for public and
private scientific, and biotech corporations and startup companies
•
eHealthDirect, Signatron, ArsDigita and Thermo Fibergen
Elena Chekhova, PhD
Program Manager
•
Over10 years of experience working in the biotech and life sciences industries,
project management, manufacturing and business development.
•
Regis Tech., Decode, Zafgen, Boston College, Tokai Pharma, MIT, University of
Dortmund, Harvard University |
 NASH
and Liver Fibrosis are Multi- Billion Dollar Markets In US Alone
Transplants
(6,291*)
Wait List
(17,000**)
Death From Cirrhosis
(44,677
#
)
Cirrhosis
(400,000
##
)
NASH: 9-15 Million
&
* Performed in US in 2010 (UNOS)
* * Prevalence in US 2010 (UNOS)
•
The ONLY current therapy for advanced fibrosis (cirrhosis) is liver
transplantation •
No approved medical therapy for fibrosis
•
While there are treatments for some underlying etiologies (Hepatitis C and B), there
is no approved therapy for NASH
©
2012 Galectin Therapeutics
OTC:GALT
5
#
Deaths in 1998 (AASLD Workshop, 2001)
##
Prevalence in US 1976-1980 (NIDDK)
Hepatitis C, Hepatitis B, Alcohol
&
Prevalence in US 2011 (NIH) |
 Immune
Enhancement is Synergistic With Many Emerging Cancer Immunotherapies
•
Enhancing the ability of the immune system to recognize and kill
tumor cells is a very active area in the personalized approach to
cancer therapy
•
Two agents have been approved for use to date
•
Dendritic cell vaccine: Provenge (Dendreon)
•
T-cell activator (CTLA4 receptor mAb): Ipilimumab (Yervoy, BMS)
•
Many more vaccines and activators in development
•
Our
drugs
reverse
the
“Galectin
Effect”
by
which
tumors
inhibit
the
immune system and will be synergistic
with all tumor
immunotherapies. May be effective with unaltered immune system
•
While
tumor
vaccines
are
patient
and
tumor
specific,
reversal
of
the
“Galectin Effect”
is universal
•
The tumor vaccine market is forecast to be over $7 billion by 2015
©
2012 Galectin Therapeutics
OTC:GALT
6 |
 •
Science of Galectins
•
Galectin Function
•
Galectin Inhibitors
•
Liver Fibrosis
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
•
Immune Enhancement in Cancer Therapy
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
©
2012 Galectin Therapeutics
OTC:GALT
7 |
 Galectin Proteins Are Critical Participants In
Pathogenesis of Many Fibrotic and Neoplastic
Diseases
©
2012 Galectin Therapeutics
OTC:GALT
8
PROMOTE
PATHOLOGY
Markedly Increased in:
1.
Inflammation
2.
Fibrosis
3.
Cancer
*Galectin-3 is key galectin in pathological processes
Secreted
Galectin
Proteins*
Bind to cell surface
and matrix
glycoproteins
(galactose residues)
Modulate cell
signaling
Promote cell-cell
interactions
Promote cell-
matrix interactions |
 Galectin
Proteins
Galectin
Inhibitor
Galectin Inhibitors: A New Class of
Pathology Modulators
©
2012 Galectin Therapeutics
OTC:GALT
9
•
Novel complex carbohydrate drugs that target
secreted and membrane-associated galectins by
virtue of high molecular weight
•
Strongest binding to galectin-3, most prominent
galectin in disease processes
•
Binding to galectins disrupts function and modulates
multiple
cellular pathways in pathology representing
a new class of therapeutic agents
•
Low toxicity potential as a carbohydrate
with no toxic metabolites
•
Two classes of compounds under development
•
GM-CT
•
GR-MD
•
Low manufacturing costs; abundant natural plant
product starting materials
•
Strong patent position; developed in house; no
encumbrances |
 •
Science of Galectins
•
Galectin Function
•
Galectin Inhibitors
•
Liver Fibrosis
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
•
Immune Enhancement in Cancer Therapy
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
©
2012 Galectin Therapeutics
OTC:GALT
10 |
 Galectin-3 Is A Critical Target For
Therapy of Liver Fibrosis
Galectin-3 is produced in large amounts by fibrotic liver (animal and
human)
Galectin-3 is essential in mice for the development of liver fibrosis.
Fibrosis due to toxin exposure or fatty liver DOES NOT occur in
mice that lack the galectin-3 gene.
Galectin inhibitors block production of fibrogenic markers in the key
human cell (stellate cells) responsible for liver fibrosis
Galectin inhibitors reverse experimental fibrosis in rats induced by both
fibrosis and fatty liver
©
2012 Galectin Therapeutics
OTC:GALT
11
Key Evidence:
Key Evidence: |
 Galectin Inhibitor GR-MD-02 Effectively
Treats Toxin-Induced Liver Fibrosis in Rats
©
2012 Galectin Therapeutics
OTC:GALT
12
Galectin Therapeutics Data: Study performed under
contract by Dr. Ji-yao Wang of Fudan University, Shanghai, China
Liver Fibrosis, induced by injection
of chemical toxin for 8 weeks
Regression of Fibrosis after 4 weeks
of treatment with GR-MD-02 |
 GR-MD-02 Prevents and Completely Reverses
Fibrosis in Non-Alcoholic Steatohepatitis (NASH)
©
2012 Galectin Therapeutics
OTC:GALT
13
normal
mouse 0.33
GR-MD-02 also reduces fat, liver cell death, and inflammation
Early Rx
Late Rx |
 ©
2012 Galectin Therapeutics
OTC:GALT
14
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
2012
2013
2014
Post Transplant Fibrosis
Phase II Post Tx Fibrosis Trial
Phase I DE
NASH
NASH
Fibrosis Development Program: GR-MD-02
Phase II NASH with Fibrosis Trial
Plan to File Fast Track Designation
Plan to File Orphan Disease Status
Plan to File Fast Track Designation
Pre-Clinical (Target SQ)
Top line
results
Top line
results
Top line
results |
 Competitive Positioning in NASH
©
2012 Galectin Therapeutics
OTC:GALT
15
General Mechanism
Examples
Comments
Treat Diabetes and
Insulin Resistance
•
Pioglitazone
•
Failed to achieve significant endpoints in phase II and
phase III clinical trials
Inhibit Lipid
Metabolism
•
Aramchol
•
Colesevelam
•
Cholesterol inhibition, no clinical results; weak
mechanism
•
Intestinal bile salt binder, no clinical results, weak
mechanism
Modulate the
Immune System
•
EGS21 (Enzo)
•
Pentoxifylline
•
Abandoned after phase II trial
•
Non significant phase III results
Protease Inhibition
•
GS-9450 (Gilead)
•
Liver Tox: abandoned (caspase inhibitor)
Anti-Oxidant
•
MND-21 (Mochida)
•
Cysteamine (Raptor)
•
Omega-3 fatty acid (phase II trial)
•
Increase glutathione in liver cells (phase II)
GR-MD-02:
Most attractive mechanism: multiple sites of action in disease
Independent of glucose or lipid metabolism
Reverses established fibrosis
Strong safety profile: Little chance of toxicity
|
 •
Science of Galectins
•
Galectin Function
•
Galectin Inhibitors
•
Liver Fibrosis
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
•
Immune Enhancement in Cancer Therapy
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
©
2012 Galectin Therapeutics
OTC:GALT
16 |
 The
Vast Majority of Cancers Secrete Large Amounts of Galectins Which Have Multiple
Roles in Tumor Pathogenesis
•
Tumor cell invasion:
extracellular matrix
adhesion & detachment
•
Stromal cell function
•
Metastasis:
cell invasion and migration
•
Angiogenesis
•
Tumor immunity has
recently been shown to be
critically affected by
galectins
©
2012 Galectin Therapeutics
OTC:GALT
17 |
 GM-CT-01 Has Proven Safe in Over 100 Human
Subjects and Has Been Shown to Have Effect In
Colorectal Cancer
Cancer Trial
(DAVFU-003)
Day 0
Day 28
GM-CT-01
Chemo (5-FU)
•
Phase II trial of 5-FU plus GM-CT-01 in line 3/4 therapy of metastatic
colorectal cancer
•
6.7 months median survival and reduced 5-FU related side effects
•
In similar patients, Erbitux
®
had a 6.1 month survival compared to 4.6
months with no therapy
•
FDA
confirmed
that
preclinical
and
clinical
data
are
adequate
to
proceed
with
large clinical trials
•
Deferring clinical trials in colorectal cancer to explore new exciting role for
galectin inhibitors in cancer immunotherapy
©
2012 Galectin Therapeutics
OTC:GALT
18 |
 Tumor
Infiltrating T-Cells Are Able to Recognize and Kill Tumor Cells
©
2012 Galectin Therapeutics
OTC:GALT
19
Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in
Brussels, Belgium in collaboration with Galectin Therapeutics
Cytokines (e.g., INF)
Kill tumor cells
Tumor-Infiltrating
Cytotoxic T-Cells
(CD8+ T-Cells)
Tumor Cells |
 “Galectins Effect”: Tumors Inactivate Tumor-Infiltrating
T-Cells Through Secretion of Galectin-3 Which Coats
Surface of T-Cells and Alters Receptor Function
©
2012 Galectin Therapeutics
OTC:GALT
20
Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in
Brussels, Belgium in collaboration with Galectin Therapeutics
Cytokines (e.g., INF)
Kill tumor cells
Galectin-3
Tumor-Infiltrating
Cytotoxic T-Cells
Tumor Cells |
 GM-CT-01
Blocks
the
“Galectins
Effect”
and
the
Restores the Ability of Tumor-Infiltrating T-Cells to Kill
Tumor Cells
©
2012 Galectin Therapeutics
OTC:GALT
21
Experiments performed by Dr. Pierre van der Bruggen of the Ludwig Institute in
Brussels, Belgium in collaboration with Galectin Therapeutics
Cytokines (e.g., INF)
Kill tumor cells
Galectin-3
GM-CT-01
Tumor-Infiltrating
Cytotoxic T-Cells
Tumor Cells |
 Melanoma “Proof of Concept”
Clinical
Trial Design
©
2012 Galectin Therapeutics
OTC:GALT
22
Phase I/II study of peptide vaccination associated with GM-CT-01
in patients with advanced metastatic melanoma
IMPD approved by EMA
Group 2 patients have additional injection of GM-CT-01 in cutaneous
tumors |
 Tumor
Immune Enhancement Development Program ©
2012 Galectin Therapeutics
OTC:GALT
23
2012
2013
2014
Preclinical Efficacy Studies
GM-CT-01
Phase I/II Melanoma Trial
Top line
results in
Stage 1
Top line
results in
Stage 2
Efficacy in immune
competent mice with
syngeneic tumors
Pursue
Partnering
Discussions
Q1
Q2
Q4
Q1
Q3
Q2
Q3
Q4
Q1
Q2
Q3
Q4 |
 Competitive Positioning In Tumor
Immunotherapy
•
Market for tumor vaccines is expected to grow to $7B by 2015. If
ipilimumab (Yervoy, BMS) is included, market is even larger.
•
Blocking
the
“Galectin
Effect”
would
be
synergistic
with
all
types
of
tumor vaccines or immune stimulatory approaches.
•
In this regard, competition will come from other galectin-blockers.
While
there
are
several
companies
exploring
galectin
inhibitors,
they
are early in development or have disadvantages related to our drugs.
•
Galectin Therapeutics is best positioned with a human trial in cancer
immunotherapy
using
a
demonstrated
safe
drug.
©
2012 Galectin Therapeutics
OTC:GALT
24 |
 •
Science of Galectins
•
Galectin Function
•
Galectin Inhibitors
•
Liver Fibrosis
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
•
Immune Enhancement in Cancer Therapy
•
Mechanism of Action
•
Regulatory and Clinical Plan
•
Competitive Positioning
©
2012 Galectin Therapeutics
OTC:GALT
25 |
 SUMMARY
Novel Mechanism &
Compounds
•
First in class, proprietary compounds that inhibit galectin proteins.
•
Novel class of safe, complex carbohydrate drugs.
•
Strong patent position; Own 100% of commercial rights.
Large Market
Opportunities
•
NASH
and
liver
fibrosis
indications
would
be
first
therapies
for
completely
unmet medical needs, representing a multi-billion dollar market.
•
Enhanced
immune
killing
of
cancer
cells
is
synergistic
with
many
current
and experimental therapies, expected to be a $7 billion market by 2015.
Near Term Milestones
•
GR-MD-02: IND Dec 2012; Phase I Q1 2013 with results Q3 2013;
Phase II results end of 2014.
•
GM-CT-01: Phase I/II interim results Dec. 2012.
Experienced
Management Team
and Board
•
Management team has collective experience in multiple biotechnology
and large Pharma companies and relevant scientific areas. Can deliver
on the program.
•
Strong Board with experience in large and entrepreneurial companies
and pharma/biotechnology. James Czirr, Executive Chair.
©
2012 Galectin Therapeutics
OTC:GALT
26 |