Galectin Therapeutics Reports 2014 Financial Results, Provides Business Update
March 18 2015 - 4:15PM
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and
cancer, today reported financial results for the year ended
December 31, 2014. These results are included in the Company's
Annual Report on Form 10-K, which has been filed with the U.S.
Securities and Exchange Commission.
"I am pleased with our many accomplishments during 2014 as we
continue to advance programs with GR-MD-02 for the treatment of
nonalcoholic steatohepatitis (NASH) with advanced fibrosis. We
completed a successful Phase 1 clinical trial and announced final
data in January 2015 that were supportive of our plans to begin a
Phase 2 program with GR-MD-02 in advanced fatty liver disease, or
NASH with fibrosis and cirrhosis," said Peter G. Traber, M.D.,
president, chief executive officer and chief medical officer of
Galectin Therapeutics. "As announced last month, we submitted the
Phase 2 clinical trial protocol to the U.S. Food and Drug
Administration (FDA) to evaluate the safety and efficacy of
GR-MD-02 for the treatment of liver fibrosis and resultant portal
hypertension in patients with NASH cirrhosis, the primary endpoint
being to determine the change in the hepatic venous pressure
gradient (HVPG) as compared with placebo. The FDA has indicated
that HVPG may serve as a surrogate primary endpoint for NASH
cirrhosis. We submitted a request for a Special Protocol Assessment
with the clinical protocol for this trial. Additionally, we are
planning to conduct a separate, shorter Phase 2 trial in NASH
patients with advanced fibrosis. We expect to begin enrolling
patients in both trials during the second quarter of 2015."
Dr. Traber continued, "We are also supporting independent
research with GR-MD-02 in combination with two commercial melanoma
drugs, as preclinical research has shown our compound enhances the
efficacy of immune checkpoint blockade therapies. Currently
GR-MD-02 is in a Phase 1b study in combination with Yervoy®, and a
Phase 1b study in combination with Keytruda® is expected to be
initiated in the second quarter of 2015. Preclinical work in mouse
cancer models with GR-MD-02 added to checkpoint inhibitors shows a
boost in anti-tumor immunity, a reduction in tumor size and
increased survival.
"We have an exciting year ahead of us, and we look forward to
advancing GR-MD-02 through various clinical trials with the goal of
providing a new treatment to the nearly 28 million Americans
afflicted with NASH, of which up to 6 million have advanced
fibrosis," Dr. Traber concluded.
For the year ended December 31, 2014, the Company reported a net
loss applicable to common stockholders of $17.0 million, or ($0.78)
per share, compared with a net loss applicable to common
stockholders of $21.9 million, or ($1.30) per share, for 2013. The
decrease in net loss applicable to common stockholders is largely
due to an $8.8 million or ($0.53) per share one-time, non-cash
charge related to the modification of certain warrants recorded in
the second quarter of 2013 and an unrelated one-time, non-cash
stock compensation charge of $1.0 million or ($0.06) per share
recorded in the third quarter of 2013, which were partially offset
by increased research and development expenses primarily related to
our clinical program.
Research and development expense for the 2014 was $8.4 million,
compared with $5.7 million for 2013. The increase primarily relates
to increased costs for our Phase 1 clinical trial, which was
completed in 2013, and increases in preclinical and drug
manufacturing costs, and in planning activities in preparation for
our Phase 2 clinical program.
General and administrative expense for 2014 was $7.0 million,
compared with $6.4 million for 2013. The primary reasons for the
increase were related to increased legal and insurance expense.
As of December 31, 2014, the Company had $29.1 million of
non-restricted cash and cash equivalents available to fund future
operations. In January and February of 2015, the Company received
$4.1 million in net proceeds from the issuance of common shares
through its At-the-Market stock issuance program. The Company
believes that cash on hand of $29.7 million as of March 13, 2015,
is sufficient to fund its operations and research and development
activities through September 30, 2016.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based
therapies for the treatment of fibrotic liver disease and cancer
based on the Company's unique understanding of galectin proteins,
which are key mediators of biologic function. Galectin seeks to
leverage extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. The Company is pursuing a
development pathway to clinical enhancement and commercialization
for its lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains 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 management's current
expectations and are subject to factors and uncertainties that
could cause actual results to differ materially from those
described in the statements. These statements include those
regarding the hope that Galectin's development program for GR-MD-02
will lead to the first therapy for the treatment of fatty liver
disease with cirrhosis. Factors that could cause actual performance
to differ materially from those discussed in the forward-looking
statements include, among others, that Galectin may not be
successful in developing effective treatments and/or obtaining the
requisite approvals for the use of GR-MD-02 or any of its other
drugs in development. The Company's current clinical trial and any
future clinical studies may not 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 Galectin's drugs are subject to change at any time based on the
changing needs of the Company as determined by management and
regulatory agencies. There is no certainty that FDA and Company
will agree on a SPA or that a SPA would ultimately be acceptable to
FDA nor result in approval of GR-MD-02. Regardless of the results
of any of its development programs, Galectin may be unsuccessful in
developing partnerships with other companies or raising additional
capital that would allow it to further develop and/or fund any
studies or trials. Galectin has incurred operating losses since
inception, and its ability to successfully develop and market drugs
may be impacted by its ability to manage costs and finance
continuing operations. For a discussion of additional factors
impacting Galectin's business, see the Company's Annual Report on
Form 10-K for the year ended December 31, 2014, and subsequent
filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause
its views to change, management disclaims any obligation to update
forward-looking statements.
Galectin Therapeutics and its associated logo is a registered
trademark of Galectin Therapeutics Inc.
Yervoy® is a registered trademark of Bristol-Myers Squibb
Condensed Consolidated Statements of
Operations
|
Year
Ended December 31, |
|
2014 |
2013 |
|
(in thousands, except per share
data) |
Operating expenses: |
|
|
Research and development |
$ 8,425 |
$ 5,688 |
General and administrative |
7,005 |
6,416 |
Total operating expenses |
15,430 |
12,104 |
Total operating loss |
(15,430) |
(12,104) |
Other income: |
|
|
Interest and other |
(358) |
16 |
Total other income |
(358) |
16 |
Net loss |
$(15,788) |
$(12,088) |
Preferred stock dividends and accretion
costs |
(1,172) |
(1,096) |
Modification of warrants |
-- |
(8,763) |
Net loss applicable to common stock |
$(16,960) |
$(21,947) |
Basic and diluted net loss per share |
$ (0.78) |
$ (1.30) |
Shares used in computing basic and diluted
net loss per share |
21,849 |
16,874 |
|
|
|
Condensed Consolidated Balance Sheet
Data
|
December 31,
2014 |
December 31,
2013 |
|
(in thousands) |
Cash and cash equivalents |
$29,128 |
$10,489 |
Total assets |
29,677 |
10,713 |
Total current liabilities |
1,703 |
2,486 |
Total liabilities |
1,703 |
2,486 |
Total redeemable, convertible preferred
stock |
6,779 |
6,746 |
Total stockholders' equity |
$21,195 |
$1,481 |
CONTACT: Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com.
LHA
Kim Golodetz
(212) 838-3777
kgolodetz@lhai.com
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