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
May 26, 2011
Date of Report (Date of earliest event reported)
PRO-PHARMACEUTICALS, 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 Pro-Pharmaceuticals, Inc. (“Company”), announced the Company’s new name and presented a corporate update contained in the slide presentation attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) at the Company’s Annual Stockholders Meeting held on May 26, 2011.
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 | 2011 Annual Stockholders Meeting Presentation Slides - dated May 26, 2011. | |
| 99.2 | Press Release entitled “Pro-Pharmaceuticals Changes Company Name to Galectin Therapeutics” dated May 26, 2011. | |
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.
| PRO-PHARMACEUTICALS, INC. | ||
| By: |
/s/ ANTHONY SQUEGLIA | |
| Anthony Squeglia | ||
| Chief Financial Officer | ||
Date: May 26, 2011
Exhibit Index
| Exhibit Number |
||
| 99.1 |
2011 Annual Stockholders Meeting Presentation Slides dated May 26, 2011. | |
| 99.2 |
Press Release entitled “Pro-Pharmaceuticals Changes Company Name to Galectin Therapeutics” dated May 26, 2011. | |
 Annual Stockholders Meeting
May 26, 2011
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.
©
2011 Galectin Therapeutics
2 |
 Annual
Stockholders Meeting Highlights
All resolutions passed
•
Authorized Board of Directors to change name
•
All BOD members elected
•
BOD may expand to 11 members
•
Increased stock incentive plan to 20,000,000 shares
•
Ratified appointment of McGladrey & Pullen as auditor for 2011
©
2011 Galectin Therapeutics
3 |
 Pro-Pharmaceuticals
is now
Galectin Therapeutics
New company name reflects our leadership in
galectin science and drug development
©
2011 Galectin Therapeutics
4 |
 Galectin Proteins Are Important In
Disease Pathogenesis
©
2011 Galectin Therapeutics
5
Secreted
Galectin
Proteins
1.
Bind to cell
surface and
matrix
glycoproteins
(galactose residues)
2.
Modulate cell
signaling
3.
Promote cell-cell
interactions
4.
Promote cell-
matrix interactions
PROMOTE
PATHOLOGY
Markedly Increased in:
1.
Fibrosis
2.
Cancer
3.
Inflammation |
 Galectin
Proteins
Galectin
Inhibitor
Our Galectin Inhibitors Are Novel
Carbohydrate-Based Drug Compounds
©
2011 Galectin Therapeutics
6
Carbohydrate-based, galactose-containing
drugs that bind to and inhibit galectin proteins
•
Target
secreted
galectins
and
those
associated
with
cell
membrane
•
Strong
binding
to
multiple
galectin
proteins
and
multiple
galectins
per
drug
molecule
•
High
molecular
weight
allows
long
exposure
to
galectin
containing
compartment
•
Low
toxicity
potential
as
a
carbohydrate
with no toxic metabolites
•
Low manufacturing costs
•
Strong composition of matter patent protection
•
Two major classes of compounds under
development:
GM-CT
and
GR-MD |
 We Are
The Leaders In Galectin Inhibitor Drug Development
•
Only company with galectin inhibitors in clinical
development
•
Published authoritative books in the field
©
2011 Galectin Therapeutics
7 |
 Galectins Are Involved In The
Pathogenesis Of Many Diseases
•
Fibrosis of organs
•
Nearly all cancers
•
Heart failure
•
Ischemic cardiovascular and cerebrovascular disease
•
Arthritis
•
Allergic disease
•
Eczema and skin inflammation
•
Inflammatory bowel disease
•
Eye inflammation
•
Inflammatory and autoimmune disorders
•
Response to infections
•
Kidney disease
©
2011 Galectin Therapeutics
8
Galectins implicated in: |
 How Do
We Choose Diseases For Drug Development?
•
Galectins are proven important in the mechanism of
disease
•
There are serious, life threatening consequences to
patients
•
There are no, few, or ineffective therapies
•
Our drug compounds can make a major impact
©
2011 Galectin Therapeutics
9
Treat important diseases where: |
 Strategic Approach To Drug
Development
•
Choose the right disease target and patient population
•
Design clinical development approaches that add value to
the company in shortest time possible
•
Seek partners when development program becomes
advanced and requires resources and capabilities for
managing large programs
©
2011 Galectin Therapeutics
10 |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Chemotherapy
Immunotherapy
GALECTINS
©
2011 Galectin Therapeutics
11 |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Chemotherapy
Immunotherapy
GALECTINS
©
2011 Galectin Therapeutics
12 |
 Galectin Therapeutics’
Development
Program In Liver Fibrosis
•
Liver fibrosis represents a very large unmet medical need
•
Liver fibrosis and the end stage of cirrhosis is the result of all
diseases that affect the liver
•
The only available therapy is liver transplantation
•
Galectin-3 protein is directly involved in promoting the
formation of fibrotic tissue in the liver
•
Our proprietary drug compounds reverse liver fibrosis in
pre-clinical studies
•
There are rapid clinical development pathways available
©
2011 Galectin Therapeutics
13 |
 Multiple Diseases Lead To Liver Fibrosis
And Cirrhosis With Serious Medical
Consequences
ONLY CURRENT THERAPY FOR CIRRHOSIS IS LIVER TRANSPLANTATION
•
Alcoholic liver disease
•
Chronic hepatitis C
•
Chronic hepatitis B/D
•
Steatohepatitis (NASH)
•
Autoimmune hepatitis
•
Bile ducts
•
Inherited diseases
•
Drugs and toxins
•
Other infections
ETIOLOGIES
•
GI tract bleeding
•
Jaundice
•
Ascites
•
Anemia
•
Edema
•
Encephalopathy/coma
•
Infections
•
Kidney failure
MEDICAL
©
2011 Galectin Therapeutics
14 |
 Fibrosis Of The Liver Leads To
Scarring (Cirrhosis)
Healthy
Cirrhosis
©
2011 Galectin Therapeutics
15 |
 The
Liver Fibrosis Iceberg Transplants
(8,000*)
Wait List
(17,000**)
Death from Cirrhosis
(60,000*)
Cirrhosis
(450,000**)
Liver Disease
(25,000,000**)
* Per annum in US
* * Prevalence in US
Huge medical problem in US and even bigger in rest of world
©
2011 Galectin Therapeutics
16 |
 Galectin-3 Is Markedly Increased In
Human Liver Cirrhosis
Henderson, et al. PNAS, 103:5060-5065, 2006
Normal Human Liver
Fibrotic Human Liver (Cirrhosis)
©
2011 Galectin Therapeutics
17 |
 Fibrosis Does Not Occur In Mice Where
The Galectin-3 Gene Has Been Eliminated
Henderson, et al. PNAS, 103:5060-5065, 2006
Fibrotic Mouse Liver
Gal-3 Knock Out Mouse Liver
©
2011 Galectin Therapeutics
18 |
 Fibrotic Protein
The Fibrogenic Cells In Human Liver
Are Regulated By Galectins
©
2011 Galectin Therapeutics
19
Stellate Cells |
 Galectin Inhibitors Effectively Treat
Liver Fibrosis in Rats
Liver Fibrosis induced by injection of
chemical toxin for 8 weeks
Regression of Fibrosis after 4 weeks
of treatment with GR-MD-01
©
2011 Galectin Therapeutics
20 |
 Goals
For Fibrosis Program •
Nominate optimal drug candidate to move into clinical
development (Q4 2011)
•
Submit IND to treat patients with liver fibrosis
•
Select clinical patient population for study to enable fast
track designation and seek orphan disease status
©
2011 Galectin Therapeutics
21 |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Chemotherapy
GALECTINS
Immunotherapy
©
2011 Galectin Therapeutics
22 |
 Roles
Of Secreted Galectins In Cancer The vast majority of cancers secrete large
amounts of galectins •
Tumor cell invasion:
extracellular matrix
adhesion & detachment
•
Stromal cell function
•
Metastasis:
cell invasion and
migration
•
Angiogenesis
•
Tumor immunity
©
2011 Galectin Therapeutics
23 |
 Our
Drug GM-CT-01 (DAVANAT ®
)
Shows Activity In Treatment Of
Cancer
•
Clinical studies (Phase 1 and 2 clinical trials) showed
activity of treatment of metastatic colorectal cancer
•
Phase 2 trial of 5-FU plus GM-CT-01 in line 3/4 therapy of
metastatic colorectal cancer showed 6.7 months median
survival. In similar patients, Erbitux
®
had a 6.1 month
survival compared to 4.6 months with no therapy
•
Notably, serious adverse events were markedly lower in
our studies with 5-FU/GM-CT-01 than in comparison to
other studies using 5-FU
©
2011 Galectin Therapeutics
24
ERBITUX
®
is a registered trademark of ImClone LLC, a wholly-owned
subsidiary of Eli Lilly and Company. |
 GM-CT-01 Reduces 5-FU
Chemotherapy Related Side Effects
Simultaneous
improved
efficacy
with
reduction
in
side
effects
of
standard
chemotherapy would be desirable in cancer therapeutics
Data
on
5-FU+GM-CT-01
compiled
from
patients
receiving
full
dose
therapy
in
studies
DAVFU-001,
003,
006,
and
007
©
2011 Galectin Therapeutics
25 |
 Development Approach In
Colorectal Cancer
•
Studies demonstrate potential utility of galectin inhibitors in
combination with chemotherapy in cancer
•
FDA has confirmed that preclinical and clinical data are
adequate to proceed with large clinical trials
•
Our colorectal cancer program remains active, but we are
deferring new clinical trials pending data from the tumor
immunology clinical trial that may improve the design of future
studies
•
More rapid international registration is an approach that may
provide revenue to support development programs and gain
additional clinical experience with GM-CT-01
©
2011 Galectin Therapeutics
26 |
 Registration And Marketing GM-CT-01
In Colombia And Latin America
•
The
government
of
Colombia,
and
oncology
key
opinion
leaders
in
that
country,
expressed
an
interest
in
making
GM-CT-01
available
for
use
in
Colombia
for
patients
with
metastatic
colorectal
cancer
•
Equally
interested
in
the
increased
tumor
efficacy
and
reduction
in
5-
FU
related
side
effects
•
Our
partner
Pro-Caps
has
submitted
a
marketing
application
to
INVIMA
(FDA
equivalent)
and
has
indicated
our
clinical
data
should
be
sufficient
for
approval
•
With
approval,
Pro-Caps
expects
sales
to
begin
in
2012
•
Upon
success
in
Colombia,
we
have
the
opportunity
to
seek
approval
in
other
Latin
American
countries
(reciprocity
with
12
other
countries)
©
2011 Galectin Therapeutics
27 |
 Goals
for Cancer Chemotherapy Program
•
Receive approval, market and sell GM-CT-01 in Colombia
for use in combination with 5-FU in metastatic colorectal
cancer
•
Pursue post-marketing clinical trials in Colombia to
acquire additional data on use of GM-CT-01
©
2011 Galectin Therapeutics
28 |
 Disease Area Development Programs
Cancer
Fibrosis
Liver Fibrosis
Chemotherapy
Immunotherapy
GALECTINS
©
2011 Galectin Therapeutics
29 |
 Enhancing Anti-Tumor Immunity Is A
Promising Effect Of Blocking Galectins
©
2011 Galectin Therapeutics
30
•
Tumor cell invasion:
extracellular matrix
adhesion & detachment
•
Stromal cell function
•
Metastasis:
cell invasion and
migration
•
Angiogenesis
•
Tumor immunity |
 Development Program In Cancer
Immunotherapy
•
Galectin proteins secreted by tumor cells are directly
responsible for inhibiting the ability of immune cells to kill
tumors
•
We have shown that GM-CT-01 inhibits galectin proteins and
restores the ability of immune cells to kill tumor cells, in
collaboration with The Ludwig Institute in Brussels, Belgium
•
This approach is being tested in patients in a clinical trial for
treatment of metastatic malignant melanoma
•
Market for tumor vaccines is expected to grow to $7B by 2015
©
2011 Galectin Therapeutics
31 |
 Tumor-Specific
Cytotoxic T-Cell
Lymphocytes
Blocking Galectins Enhances Tumor
Killing By Immune System
This mechanism is important in cancer treatment, but can also be
used to
boost the activity of tumor vaccines
©
2011 Galectin Therapeutics
32
Tumor Cells
Cytotoxicity |
 GM-CT-01 In Tumor Immunotherapy
•
This
mechanism
may
boost
the
activity
of
tumor
vaccines,
and
may
be
important
generally
in
cancer
treatment
•
A
Phase
1/2
study
is
scheduled
to
begin
Q3
2011
•
Patients
with
advanced
metastatic
melanoma
•
Treatment
Regimen:
tumor-specific
peptide
vaccination
combined
with
systemic
and
intra-tumor
GM-CT-01
•
Galectin
Therapeutics:
provides
study
drug
•
The
Ludwig
Institute:
funds
and
conducts
the
clinical
trial
©
2011 Galectin Therapeutics
33 |
 Goals
for Tumor Vaccine Program •
Initiate clinical trial in patients with metastatic melanoma
vaccine (Q3 2011)
•
Seek collaborative programs with companies developing
tumor vaccines
©
2011 Galectin Therapeutics
34 |
 Pipeline
Pre-Clinical
Phase 1
Phase 2
Phase 3
Registration
Submitted
Colorectal Cancer
GM-CT-01
•
International (Colombia)
•
United States
Tumor Vaccine
GM-CT-01
Liver Fibrosis
GM-CT-01
GM-CT-02
GM-MD-01
GM-MD-02
©
2011 Galectin Therapeutics
35 |
 Condensed Balance Sheet
March 31, 2011
Assets
(in 000’s)
Cash and cash equivalents
$ 6,948
Total assets
$ 7,124
Liabilities and Stockholders Equity (Deficit)
Accounts payable and accrued expenses
$ 364
Deferred revenue
200
Warrant liabilities
294
Total liabilities
865
Series B-1 and B-2
4,196
Series C
2,203
Total stockholders' equity (deficit)
(140)
Total liabilities and stockholders´
equity
$ 7,124
36
©
2011 Galectin Therapeutics |
 Galectin Therapeutics Highlights
•
Leader
in
galectin
science
and
drug
development
with
a
pipeline
of
novel
and
proprietary
carbohydrate-based
drug
compounds
that
inhibit
galectins
•
Galectins
are
implicated
in
a
wide
variety
of
serious
disease.
Active
programs
in
liver
fibrosis,
cancer
immunotherapy
and
cancer
chemotherapy
•
Liver
fibrosis
program
is
a
novel
approach
to
treat
a
serious
and
significant
unmet
medical
condition
which
is
poised
to
enter
clinical
trials
•
Cancer immunotherapy Phase 1/2 trial starting Q3 2011 in collaboration
with
The
Ludwig
Institute,
Brussels,
Belgium
•
Cancer
chemotherapy
program
with
promising
results
37
©
2011 Galectin Therapeutics |
 Annual Stockholders Meeting
Thank you for your attention |
Exhibit 99.2
Pro-Pharmaceuticals Changes Company Name
to Galectin Therapeutics
New Name Highlights Company’s Scientific Expertise in Galectins Applied to the
Treatment of Serious Diseases Such as Fibrosis and Cancer
Newton, MA – May 26, 2011 – Pro-Pharmaceuticals, Inc. (OTC BB: PRWP) today announced that it has changed its name to Galectin Therapeutics Inc. to more accurately reflect the Company’s core expertise in galectin science and its leading platform for the creation of galectin inhibitors to treat serious diseases including fibrosis and cancer. The name change was implemented by Galectin’s Board of Directors pursuant to authorization by the Company’s shareholders in a vote recorded at the Annual Stockholders Meeting on May 26, 2011. Galectin Therapeutics’ stock will continue to trade under the symbol “PRWP” but the Company anticipates that it will begin trading under a new ticker symbol in the near future.
“Galectin proteins are critical drug targets because they play a fundamental role in the progression of a wide variety of serious diseases,” commented James Czirr, Executive Chairman. “We are naming our company Galectin Therapeutics based on the combination of our pioneering galectin science coupled with our novel carbohydrate drug discovery platform.”
“We anticipate exciting developments in each of the programs in our promising portfolio of galectin inhibitors over the near-term,” said Peter G. Traber, M.D., President and CEO. “We are enthusiastic about our liver fibrosis program which is in late pre-clinical development. The mechanism of galectin inhibition is well suited to the treatment of liver fibrosis, a critical condition with a high patient mortality, high cost to the healthcare system and no therapeutic options other than liver transplantation. In tumor immunology, a Phase 1/2 study of GM-CT-01 in combination with various tumor antigens for metastatic melanoma is planned for the third quarter of this year through our collaboration with The Ludwig Institute of Cancer Research in Belgium. Additionally, we are seeking approval for GM-CT-01 used in combination with 5-FU to treat colorectal cancer in Colombia as part of a South American commercialization effort with a decision anticipated in early 2012.”
Galectin Therapeutics Portfolio Overview
Galectin Therapeutics is focusing its galectin inhibitor development efforts in two key disease areas: fibrosis and cancer.
| • | Liver Fibrosis: The Company is developing galectin inhibitors to treat liver fibrosis, the end-stage of cirrhosis, caused by a variety of serious conditions. Liver fibrosis is a disease with no current treatment options except liver transplantation. Galectin Therapeutics candidates have demonstrated the ability to arrest and reverse liver fibrosis in pre-clinical studies. |
Galectin Therapeutic’s efforts in cancer encompass two distinct programs, cancer chemotherapy and cancer immunotherapy:
| • | Cancer Immunotherapy: The Ludwig institute is planning a Phase 1/2 trail of GM-CT-01 for patients with advanced metastatic melanoma. Patients will receive a tumor-specific peptide vaccination combined with systemic and intra-tumor GM-CT-01. |
| • | Cancer Chemotherapy: The Company is currently pursuing marketing approval in Colombia for the use of GM-CT-01 (formerly known as DAVANAT) in combination with 5-FU for metastatic colorectal cancer. GM-CT-01 will be commercialized by Galectin Therapeutic’s partner, Pro-Caps, pending regulatory approval in Colombia. Further development and commercialization of GM-CT-01 is dependent on the outcome of approval and marketing efforts in South America and the design of clinical trials in the United States. |
Forward Looking Statements
This press release 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.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for fibrotic liver disease and cancer based on the company’s unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com
Contact
Anthony D. Squeglia
Chief Financial Officer
617.559.0033
squeglia@galectintherapeutics.com.