Galectin Therapeutics Reports Second Quarter 2013 Financial Results

Galectin Therapeutics Reports Second Quarter 2013 Financial Results

NORCROSS, Ga., Aug. 14, 2013 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc.
(Nasdaq:GALT), the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, today reported its financial results
for the second quarter and first six months ended June 30, 2013. These results
are included in the Company's Quarterly Report on Form 10-Q, which has been
filed with the Securities and Exchange Commission.

"During the second quarter, we continued preparing for our Phase 1 clinical
trial of GR-MD-02 for patients with nonalcoholic steatohepatitis (NASH or
fatty liver disease) with advanced fibrosis and in July, we successfully dosed
the first patient. Additionally, we recently announced the FDA has granted
Fast Track status for GR-MD-02 for NASH. The successful first patient dosing
in the clinical trial of GR-MD-02 and Fast Track designation are critical
milestones in Galectin's development program and there are currently no
treatments for fatty liver disease with advanced fibrosis; these milestones
take us closer to bringing a first-in-class treatment to the millions of
Americans suffering from this silent epidemic," said Peter G. Traber, M.D.,
Chief Executive Officer, President and Chief Medical Officer, Galectin
Therapeutics. "This first-in-man study will evaluate the safety, tolerability,
and exploratory biomarkers for efficacy for single and multiple doses of
GR-MD-02 when administered to patients with fatty liver disease with advanced
fibrosis, and we expect top line clinical results for Phase 1 sometime late in
2013 or early 2014."

At June 30, 2013, the Company had $5.1 million of non-restricted cash and cash
equivalents available to fund future operations. Subsequent to quarter end,
the Company received $2.4 million from the exercise of warrants. The Company
believes that the cash on hand at quarter end and received subsequently is
sufficient to fund operations and planned research and development through the
first quarter of 2014. The Company is currently exploring and evaluating
several alternatives for obtaining additional funding.

For the second quarter of 2013, the Company reported a net loss applicable to
common stock of $11.6 million, or ($0.72) per share, basic and diluted,
compared with a net loss applicable to common stock of $3.0 million or ($0.19)
per share for the same period in 2012. The increase in net loss applicable to
common stock is primarily due to an $8.8 million or ($0.54) per share
one-time, non-cash charge related to the extension of the exercisable period
of certain warrants. Research and development expense for the second quarter
of 2013 was $1.3 million, compared with $1.2 million for the same period in
2012. The increase is due primarily to clinical program expenses related to
the Phase I clinical trial. General and administrative expense for the second
quarter of 2013 was $1.2 million, compared with $1.5 million for the same
period in 2012. The primary reasons for the decrease are due to decreased
stock-based compensation and rent, offset by increased legal expenses.

For the six months ended June 30, 2013, the Company reported a net loss
applicable to common stock of $15.1 million, or ($0.94) per share, basic and
diluted, compared with a net loss of $5.2 million, or ($0.36) per share for
the same period in 2012. The increase in net loss applicable to common stock
is primarily due to an $8.8 million or ($0.54) per share non-cash charge as
disclosed above. Research and development expense for the six-months ended
June 30, 2012 increased to $3.1 million compared with $2.1 million for the
same period in 2012, due primarily to clinical program expenses related to the
Phase I clinical trial. As we continue to enroll patients in the Phase I
trial, we expect our clinical activities costs may increase and fluctuate from
quarter to quarter as the trial progresses. General and administrative expense
for the six-months ended June 30, 2013 increased to $2.7 million compared with
$2.5 million for the same period in 2012, due primarily to increased legal
expenses related to ongoing litigation with the Company's former CEO and
investor relations expenses, offset by decreased rent expense due to our
relocation to Georgia in October 2013.

About Galectin Therapeutics

Galectin Therapeutics (Nasdaq:GALT) 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, 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.

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. These statements
include those regarding our plans, expectations and goals regarding the
clinical trial, our Fast Track submission and the potential benefits of a Fast
Track designation, and the sufficiency of cash on hand to fund future
operations and planned research and development into the first quarter of
2014. Factors that could cause our actual performance to differ materially
from those discussed in the forward-looking statements include, among others,
that our plans, expectations and goals regarding the clinical trial are
subject to factors beyond our control and that the receipt of a Fast Track
designation from FDA is no guarantee that we avoid delays in the development
of our drug product and provide no assurance of FDA approval of our drug
development plans. Our clinical trial may not produce positive results in a
timely fashion, if at all, and any necessary changes during the course of the
trial could prove time consuming and costly.We may have difficulty in
enrolling candidates for testing, which would impact our estimates regarding
timing, and we may not be able to achieve the desired results. Upon receipt of
FDA approval, 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 this proposed
indication. Plans regarding development, approval and marketing of any of our
drugs, including GR-MD-02, are subject to change at any time based on the
changing needs of our company as determined by management and regulatory
agencies. 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 Annual Report
on Form 10-K for the year ended December31, 2012, 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.

Galectin Therapeutics and its associated logo is a trademark of Galectin
Therapeutics Inc.

                                                                
Condensed Consolidated Statements of                              
Operations
                                                      
                                 Three Months          Six Months
                                Ended                  Ended
                                 June 30,               June 30,
                                2013        2012       2013        2012
                                (in thousands, except per share data)
                                 (unaudited)
Operating expenses:                                             
Research and development       $1,349      $1,215     $3,101      $2,116
General and administrative     1,198       1,453      2,654       2,505
Total operating expenses       2,547       2,668      5,755       4,621
Total operating loss           (2,547)     (2,668)    (5,755)     (4,621)
Other income:                                                    
Interest                       3           8          8           11
Total other income             3           8          8           11
Net loss                        $(2,544)  $(2,660) $(5,747)  $(4,610)
Preferred stock dividends and    (334)       (324)      (603)       (578)
accretion costs
Modification of warrants        (8,763)     --         (8,763)     --
Net loss applicable to common   $(11,641) $(2,984) $(15,113) $(5,188)
stock
Basic and diluted net loss per   $(0.72)   $(0.19)  $(0.94)   $(0.36)
share
Shares used in computing basic   16,236      15,710     16,158      14,360
and diluted net loss per share

                                               
                                               
Condensed Consolidated Balance Sheet Data
                                               
                                    June 30,    December 31,
                                     2013        2012
                                    (in thousands, unaudited)
Cash and cash equivalents            $5,099    $9,364
Total assets                         5,225       9,561
Total current liabilities            1,493       1,638
Total liabilities                    1,498       1,644
Total stockholders' equity (deficit) $(3,089)  $1,165

CONTACT: Jack Callicutt
         Chief Financial Officer
         678-620-3186
         ir@galectintherapeutics.com

Galectin Therapeutics, Inc. Logo
 
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