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 24, 2013
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)
Registrants 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 September 24, 2013, Galectin Therapeutics Inc. (the Company) posted a slide presentation on its website that contains a corporate summary of the Companys business. The slide presentation, which is being furnished and not filed, and is attached hereto 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.
(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 | Slide 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 24, 2013 | By: | /s/ Jack W. Callicutt | ||||
Jack W. Callicutt | ||||||
Chief Financial Officer |
- 3 -
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 managements 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
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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
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2013 Galectin Therapeutics
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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
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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
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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
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NASDAQ:GALT
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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
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NASDAQ:GALT
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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
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2013 Galectin Therapeutics
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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
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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
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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
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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
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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
©
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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
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27
Potential sites for galectin inhibition in
tumor immunology
©
2013 Galectin Therapeutics
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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
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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
©
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*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
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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
©
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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 |