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| 8-K - FORM 8-K - GALECTIN THERAPEUTICS INC | d602065d8k.htm |
 Corporate Presentation
September 2013
NASDAQ: GALT
www.galectintherapeutics.com
Exhibit 99.1 |
 Forward Looking Statements
This presentation contains, in addition to historical information, statements that
look forward in time or that express management’s beliefs, expectations
or hopes. Such statements are 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 risks and uncertainties that could cause actual results to differ
materially from those described in the statements.
These
statements
include
our
plans,
expectations
and
goals
regarding
drugs
in
development,
clinical
trials
and regulatory approval for any of our drugs or treatments, the anticipated
timeline for clinical trials and results, related market opportunities for
our drugs, potential benefits of our drugs, efforts related to partnering opportunities with other
companies, estimates regarding cash, liquidity and funding requirements for
clinical trials, and estimates regarding those impacted by NASH, liver
fibrosis and cirrhosis. The risks and uncertainties impacting these statements include that our
plans, expectations and goals regarding drugs in development, clinical trials and
regulatory approval are subject to factors beyond
our
control.
Our
clinical
trials
may
not
begin
or
produce
positive
results
in
a
timely
fashion,
if
at
all,
and
any
necessary changes during the course of such trials could prove time consuming and
costly. We may have difficulty in enrolling candidates for testing and we
may not be able to achieve the desired results. Upon receipt of regulatory approval
for any drug or treatment, we may face competition with other drugs and treatments
that are currently approved or those that are currently in development,
which could have an adverse impact on our ability to achieve revenues from the
approved indication. 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. Estimates
regarding the potential benefits of our drugs and the potential market for any of our drugs may be inaccurate
and, to the extent the estimates are correct, we may not be successful in achieving
revenues from any such drugs, as the successful marketing of any approved
drugs will be subject to strong competition within the health care industry and
patient and physician acceptance of our drugs as safe, affordable and
effective. Our ongoing discussions with other companies may not lead
to partnering opportunities, and if we are unable to partner with other companies and/or raise
additional capital, we will likely be unable to complete future stages of clinical
trials and ultimately produce revenue from our drugs in development.
Funding from potential sources of capital, including the potential exercise of warrants, may not
materialize. To date, we have incurred operating losses since our inception,
and our ability to successfully develop and market drugs 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 most recent Annual Report on
Form 10-K 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. 2
©
2013 Galectin Therapeutics
NASDAQ:GALT |
 Agenda
•
The Company and Key Team Members
•
Galectin Inhibitors
•
Fibrosis Program –
our key focus
•
Tumor Immunotherapies
•
Summary
©
2013 Galectin Therapeutics
NASDAQ:GALT
3 |
 What
We Do •
Clinical stage biopharmaceutical company targeting
fibrotic diseases and cancer with novel compounds that
inhibit galectin proteins
•
Galectin proteins are important in the development and promotion
of many fibrotic and neoplastic diseases
•
Currently in clinical trials with 2 compounds
•
GR-MD-02 for the indication of NASH (Fatty Liver Disease) with
advanced liver fibrosis: Phase 1
•
GM-CT-01 and GR-MD-02 in targeting cancer, enhance ability of
immune system to kill cancer cells. GM-CT-01 in Phase 2a
clinical trial in combination with peptide vaccine for advanced
melanoma ©
2013 Galectin Therapeutics
NASDAQ:GALT
4 |
 Key
Facts - September 20, 2013
5
©
2013 Galectin Therapeutics
NASDAQ:GALT
Trading Symbol
Nasdaq: GALT
Corporate Headquarters
Norcross, GA (suburb of Atlanta)
Stock Price; 52 Week Range
$9.34 $1.60 -
$13.21
Shares Outstanding
17.6 million
Daily Volume (50 day average)
197,930 shares
Market Capitalization
$164.4 million
Debt
$0
Cash & Equivalents
$9.8 million
Estimated Cash Runway
Funded through Q2 2014
Fiscal Year Ends
December 31
Accounting Firm
McGladrey LLP |
 Experienced Leadership Team
6
©
2013 Galectin Therapeutics
NASDAQ:GALT |
 Agenda
•
The Company and Key Team Members
•
Galectin Inhibitors
•
Fibrosis Program –
our key focus
•
Tumor Immunotherapies
•
Summary
©
2013 Galectin Therapeutics
NASDAQ:GALT
7 |
 Galectins Inhibitors
•
Galectin family (15 members) are classified by structure and the
number of
carbohydrate binding domains (CRD).
•
Galectins bind via their CRD to oligosaccharides containing terminal galactose
residues on macromolecules such as glycoproteins.
•
Function through binding glycoproteins on cell surface and extracellular space
to modulate cellular and immune system function.
•
Galectin-3 is widely expressed in mesenchymal and epithelial cells
•
Under normal physiological situations, galectin-3 is expressed at low
levels •
In areas of acute or chronic inflammation and fibrogenesis, the gal-3
expression is markedly increased. The majority of cancers express high
levels of galectin-3 •
Our proprietary drugs are complex carbohydrates with galactose residues that bind
galectin proteins (galectin-3 > galectin-1)
•
Galactomannan (GM) class: GM-CT-01
•
Galacto-rhamnogalaturonate (GR) class: GR-MD-02
•
Discovery pipeline
•
Derivatives of GM and GR for subcutaneous administration
•
Synthetic carbohydrates
•
Small organic molecule galectin inhibitors
©
2013 Galectin Therapeutics
NASDAQ:GALT
8 |
 Intellectual Property
•
GM-CT Class (current NCE is GM-CT-01)
•
US Composition of matter patent issued 2011 (expires 2023)
•
Five US issued method of use patents in combination with cancer therapy
for increased efficacy and reduced side effects
•
International Patents: 14 granted and 5 pending
•
Method of use in liver fibrosis issued 2012 (expires 2026)
•
Method of use in NASH patent pending (priority 2011)
•
Method of use for Immune Enhancement pending (priority 2011)
•
GR-MD Class (current NCE is GR-MD-02)
•
Method of use in liver fibrosis patent issued (expires 2026)
•
Method of use in NASH patent issued (expires 2031)
•
Composition of matter patent pending (priority 2011)
•
Method of use for Immune Enhancement pending (priority 2011)
9
©
2013 Galectin Therapeutics
NASDAQ:GALT
Sole ownership of compounds in development |
 Agenda
•
The Company and Key Team Members
•
Galectins and Disease
•
Fibrosis Program –
our key focus
•
Tumor Immunotherapies
•
Summary
©
2013 Galectin Therapeutics
NASDAQ:GALT
10 |
 Galectin-3 is critically important in the
development of organ fibrosis
•
Galectin-3 null mice (no galectin-3) are resistant to fibrosis
due to toxin-induced liver toxicity
•
Galectin-3 null mice are also resistant to fibrosis in:
•
Fatty liver disease
•
Kidney fibrotic disease
•
Lung fibrotic disease
©
2013 Galectin Therapeutics
NASDAQ:GALT
11
Normal mouse
No gal-3 mouse
Red stain is collagen,
the principal
component of fibrotic
tissue
Henderson, et al 2006
Mice treated with liver toxin to induce fibrosis
Normal mice develop
fibrosis whereas
those without gal-3
do not |
 Galectin Inhibitors Reverse Cirrhosis in Rat
©
2013 Galectin Therapeutics
NASDAQ:GALT
12
GR-MD-02
Vehicle
GM-CT-01
•
Animal
model
presented
a
very
high
hurdle
for
drug
treatment:
Cirrhosis induced with high dose
toxin and continued throughout drug
treatment
•
Treatment with four weekly doses
Broad bands of
collagen with nodule
formation (N)
indicates advanced
fibrosis and cirrhosis
Reduction in
collagen with thin
and broken bands
(arrow) indicates
resolving fibrosis
and cirrhosis |
 Galectin Inhibitor GR-MD-02 Improved Fat, Liver Cell
Death, Inflammation, and Fibrosis in Mouse Model of
Fatty Liver Disease with Fibrosis
GR-MD-02
©
2013 Galectin Therapeutics
NASDAQ:GALT
13
Control
Control
GR-MD-02
GR-MD-02
Fat
Cell death
Inflammation
Fat
Cell death
Inflammation
Red =
Collagen
Red =
Collagen |
 Potential Use in Lung Fibrosis: GR-MD-02
Reduces Fibrosis in Mouse Model
©
2013 Galectin Therapeutics
NASDAQ:GALT
14
Vehicle
Normal
GR-MD-02
Marked reduction in
area and severity of
fibrosis without
aggregation into larger
formations
Large areas of
confluent fibrosis.
Lung fibrosis induced by tracheal
instillation of bleomycin followed by
four infusions of either vehicle or
GR-MD-02 |
 Potential Use in Kidney Fibrosis: GR-MD-
02 Reduces Fibrosis in Diabetic Mouse
©
2013 Galectin Therapeutics
NASDAQ:GALT
15
Vehicle
Normal
GR-MD-02
Reduction in interstitial
fibrosis
Arrows show areas
of interstitial fibrosis |
 Liver
Fibrosis Development Program NASH (Non-Alcoholic SteatoHepatitis)
•
Multiple liver diseases lead to fibrosis
•
End stage fibrosis, or cirrhosis, leads to liver failure,
medical complications, and death
•
Only current therapy is liver transplant
•
There is no approved medical therapy for liver fibrosis
•
Very large unmet medical need
•
First indication is fatty liver disease with fibrosis (non-
alcoholic steatohepatitis, or NASH).
•
Prevalence of NASH in U.S. is between 9-15 million people
•
Over 25% will develop cirrhosis
•
NASH cirrhosis projected to be primary reason for liver transplant
©
2013 Galectin Therapeutics
NASDAQ:GALT
16 |
 NASH
with Fibrosis Development Program: Accomplishments
•
NASH indication chosen based on pre-clinical experiments
•
Multiple studies in animal models confirmed robust effect on
inhibition and regression of fibrosis, as well as reduction in
inflammation and cell death in the liver.
•
GR-MD-02 more effective than GM-CT-01
•
GMP drug substance and product produced by CMO
•
Studies completed in multiple species elucidating
pharmacology, pharmacokinetics, and toxicology.
•
FDA review of IND for GR-MD-02 submitted Jan. 30, 2013
resulted in approval for human clinical studies.
•
Phase 1 trial underway-
enrolling first cohort
•
FDA Fast Track designation received August 2013
©
2013 Galectin Therapeutics
NASDAQ:GALT
17 |
 Development Program: Targeting
Therapy In The Progression of NASH
18
Development of Obesity
Insulin Resistance/Diabetes
Steatosis (fatty liver)
NASH
Fibrosis
Cirrhosis
Decades
Because of effect on inflammation in NASH and ability to reduce existing
fibrosis, our clinical program will target NASH patients with advanced
fibrosis ©
2013 Galectin Therapeutics
NASDAQ:GALT |
 19
M
J
J
A
S
O
N
D
J
F
M
A
M
J
2013
2014
Cohort-1
Phase 1 Clinical Trial
©
2013 Galectin
Therapeutics
NASDAQ:GALT
•
Sites:
Top academic investigators in NASH; all US sites
•
Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3)
•
Design: Dose escalation combining single and multiple dose in design. Single IV
dose followed by three additional weekly doses in each cohort. At least
three dose escalation cohorts guided by PK. Option to add additional
cohorts. •
Dose: Starting dose of 2 mg/kg
which is within the presumptive therapeutic range
•
Primary endpoints:
•
Patient safety
•
Pharmacokinetics
•
Secondary endpoints:
•
Exploratory serum biomarkers to assess for potential treatment effect
including markers for inflammation, cell death, and fibrogenesis
Cohort-2
Cohort-3
Guided by exposure from previous cohort |
 20
Phase 2 Clinical Trial Plans
©
2013 Galectin Therapeutics
NASDAQ:GALT
•
Patient
inclusion:
Biopsy
proven
NASH
with
advanced
fibrosis
(stage 3 and potentially stage 4 with well compensated cirrhosis)
•
Design:
Randomized,
placebo
controlled,
and
double
blind.
•
Dose:
One
or
two
dosage
groups
chosen
based
on
data
from
Phase
1 trial
•
Treatment
Duration:
6-12
months,
TBD
•
Primary
endpoint:
Liver
biopsy:
Collagen
proportional
area
•
FDA-AASLD liver fibrosis endpoints workshop, September 2013
•
Galectin human NASH biopsy study ongoing
•
Secondary endpoints:
•
Liver Biopsy: NASH Activity Score and Fibrosis Stage
•
Imaging methods –
MR-fat, MR-elastography
•
Serum biomarkers based on analysis of Phase 1 data
•
Estimated
Timeline:
Start
2H
2014;
Top
line
data:
1H
2016. |
 Competition in NASH
•
Most drugs in development focus on improving NASH
activity score (fat, inflammation, and cell death) with
minimal amounts of fibrosis.
•
Few companies are focused on fibrosis which is the key
cause of liver failure in patients
•
Galectin: GR-MD-02
•
Gilead: Lysyl oxidase-like-2 mAb (GS-6624): Monoclonal antibody
that blocks the enzyme which cross links collagen fibers
•
Initiated Phase 2 trials in 2012 in patients with NASH and
fibrosis
•
Top line data Q3 2015
©
2013 Galectin Therapeutics
NASDAQ:GALT
21 |
 Fibrosis Strategy Summary
•
NASH with Advanced Fibrosis: Evidence of efficacy of
GR-MD-02 from well controlled phase 2 clinical trial
•
Other Organ Fibrosis: Potential for partnering
opportunities
•
Lung fibrosis –
pre-clinical results suggest possible use in
Idiopathic Pulmonary Fibrosis
•
Kidney fibrosis
•
Ongoing discussions with large pharmaceutical
companies
•
Discussions will provide foundation for partnering opportunities
at
the most opportune time
©
2013 Galectin Therapeutics
NASDAQ:GALT
22 |
 Agenda
•
The Company and Key Team Members
•
Galectin Inhibitors
•
Fibrosis Program –
our key focus
•
Tumor Immunotherapies
•
Summary
©
2013 Galectin Therapeutics
NASDAQ:GALT
23 |
 ©
2013 Galectin Therapeutics
NASDAQ:GALT
24
•
Marketed:
•
CTLA4 receptor mAb: Yervoy®
(Ipilimumab, BMS)
•
In Development:
•
Anti-PD-1 (nivolumab BMS; lambrolizumab Merck)
•
Anti PD-L1 (MPDL3280A , Roche)
May 22, 2010
Checkpoint Inhibitor Blockade |
 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
•
Tumor immunity has
recently been shown to be
critically affected by
galectins
25
©
2013 Galectin Therapeutics
NASDAQ:GALT |
 Cancer Therapy Strategy
•
Focus on tumor immunotherapy
•
Hypothesis: galectin inhibitors will enhance efficacy of
immunotherapies
•
Metastatic melanoma is initial cancer indication
•
We have sought collaborations with institutions that have:
•
Demonstrated clinical trial expertise in melanoma
•
Tumor immunology basic science research
•
Ability to conduct clinical trials and assist in funding
•
Two collaborations have been established
•
Ludwig Cancer Institute, Brussels Belgium
•
Robert W. Franz Cancer Research Center, Earle A. Chiles
Research Institute (EACRI) Providence-Portland Medical Center,
Portland Oregon
©
2013 Galectin Therapeutics
NASDAQ:GALT
26 |
 27
Potential sites for galectin inhibition in
tumor immunology
©
2013 Galectin Therapeutics
NASDAQ:GALT
Immunotherapies
Checkpoint Inhibitor
Blockade:
anti-CTLA4
anti-PD1
Tumor Vaccines
1. Potential for
galectin inhibitors to
enhance anti-tumor
immune response
2. Potential for galectin
inhibitors to enhance anti-
tumor activity of T-cells by
blocking “Galectin Effect” |
 Ludwig
Institute
Clinical
Trial
to
Evaluate
combination
of
melanoma
vaccine
with
GM-CT-01
28
Melanoma “Proof of Concept”
Trial:
Patients:
Metastatic melanoma
Design:
Two stage Phase 2a (6x2 cohorts in stage 1 and 23x2 cohorts in stage 2)
Regimen:
Prime with melanoma specific peptide vaccine (overall 60% of melanoma
patients express one or the other antigens) then treat with
GM-CT-01 Endpoint:
Partial or complete response by imaging
Study sites:
Ludwig Institute, Brussels Belgium; second site Antwerp
Study funding: Ludwig Institute (stage 1; 12 patients)
Group 2 patients have additional injection of GM-CT-01 in cutaneous
tumors ©
2013 Galectin Therapeutics
NASDAQ:GALT |
 Clinical Trial LUC10-001: Accrual
©
2013 Galectin Therapeutics
NASDAQ:GALT
29
•
No grade 3/4 adverse events or serious adverse events
•
Two out of three mixed responses encouraging, but no responses by RECIST
•
Patient accrual continuing
Note:
one
center
at
initiation
and
first
patient
completed
protocol
before
more
enrolled;
once
safety
confirmed
additional
patients
enrolled
and
second
center
initiated |
 30
Potential sites for galectin inhibition in
tumor immunotherapy
©
2013 Galectin Therapeutics
NASDAQ:GALT
Collaboration established in 2012 with Earle A. Chiles Research Institute
(EACRI) to evaluate the effect of galectin inhibitors on the induction of T-cell
activity alone and in combination with checkpoint inhibitor blockade.
|
 Checkpoint inhibitor blockage plus GR-MD-02 boosts
anti-tumor immunity in syngeneic mouse models of
prostate and breast cancer
©
2013 Galectin Therapeutics
NASDAQ:GALT
31
*p<0.05
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 |
 Cancer Therapy Strategy: 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.
•
Ludwig
Cancer
Institute:
Complete
ongoing
clinical
trial
with
interim results reported at appropriate intervals
•
Earle
A.
Chiles
Research
Institute
(EACRI):
Ongoing
pre-clinical
studies; phase 1 clinical trial in melanoma with combination of
Yervoy and GR-MD-02 in design phase
•
Ongoing discussions with large pharmaceutical
companies in the immunotherapy space to seek a
partnering opportunity to take beyond proof of concept
from initial clinical trials
32
©
2013 Galectin Therapeutics
NASDAQ:GALT |
 Agenda
•
The Company and Key Team Members
•
Galectins and Disease
•
Fibrosis Program –
our key focus
•
Tumor Immunotherapies
•
Summary
©
2013 Galectin Therapeutics
NASDAQ:GALT
33 |
 Finances
•
September 20, 2013 cash balance: $9.8 million
•
Raised $6 million from private placement and warrant exercises in
July/August 2013
•
Funded through Q2 2014 and completion of Phase I clinical trial
for GR-MD-02
•
Additional funding required for a Phase 2 clinical trial for
GR-MD-02
•
Ongoing discussions with potential partners
•
Actively supporting Investor Relations: Talking to new and
interested fundamental investors; growing interest in
funding Phase 2 program
•
Fundamental investors are value investors with 3-5 year
time horizon who are interested in investing at market
©
2013 Galectin Therapeutics
NASDAQ:GALT
34 |
 Development Program
•
Liver Fibrosis
•
First indication: GR-MD-02 in NASH with advanced fibrosis
•
Phase 1 clinical trial underway; interim data Jan. 2014
•
Other Organ Fibrosis: Studies to demonstrate broad
application of drugs in organ fibrosis; seek partner
•
Cancer Therapy: Combination immunotherapy to enhance
the ability of the immune system to recognize and kill tumor
cells in metastatic melanoma
•
Leverage world class expertise in basic tumor immunology and in
the conduct of melanoma clinical trials.
•
Ongoing discussions with large pharmaceutical companies
to provide foundation for partnering opportunities at the
most opportune time
©
2013 Galectin Therapeutics
NASDAQ:GALT
35 |
 Proprietary
Compounds
•
First in class, proprietary compounds that inhibit galectin proteins
•
Complex carbohydrate drugs with favorable safety profile
•
GR-MD-02: Potential to treat non-alcoholic steatohepatitis (NASH) and
other causes of liver fibrosis
•
GM-CT-01: Potential to enhance cancer immunotherapy
Validated Science
•
Pre-clinical models show galectins are critical targets for intended
diseases with 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
•
Enhancing the ability of immune system to kill cancer cells is synergistic
with many current and experimental therapies
Intellectual Property
•
Strong patent position
•
Sole ownership of compounds in development
•
No licenses granted
Experienced
Management Team
•
Management team has significant collective experience in multiple
biotech and pharmaceutical companies and relevant scientific areas
36
Investment Highlights
©
2013 Galectin Therapeutics
NASDAQ:GALT |
 APPENDIX
©
2013 Galectin Therapeutics
NASDAQ:GALT
37 |
 Inhibition of Gal-3 May Have Multiple Sites
of Action in Therapy of NASH
Stellate Cells
Macrophages
Inhibit scavenger receptor
mechanism and reduce
cellular toxicity
Potential sites of anti-galectin activity
Reduces activation of stellate
cells. TGF-
receptor activity
ECM dissolution by
macrophage action
©
2013 Galectin Therapeutics
NASDAQ:GALT
Reduce Gal-3 activation
and/or shift polarity of
macrophages
38
CONFIDENTIAL |