Galectin Therapeutics Reports 2013 Financial Results
March 21 2014 - 4:45PM
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 year ended December 31, 2013. These results are included in the
Company's Annual Report on Form 10-K, which has been filed with the
Securities and Exchange Commission.
"Many important milestones and objectives were achieved in 2013
and continuing into the first quarter of 2014. During this period,
we had significant activity involving our lead compound, GR-MD-02.
We received notification from the U.S. Food and Drug Administration
(FDA) that we may proceed with our Phase 1 clinical trial for
GR-MD-02 in patients with fatty liver disease (NASH) with advanced
fibrosis. Subsequently, we received FDA Fast Track designation for
GR-MD-02 for fatty liver disease with advanced fibrosis, and we
completed enrollment of the first cohort of patients in our Phase 1
clinical trial. Additionally, we enhanced our patent portfolio, and
we have raised funds sufficient to finance our currently planned
operations through 2015. Looking ahead, we expect to announce
the results of the first cohort of patients in our Phase 1 clinical
trial in early April 2014," said Peter G. Traber, M.D., Chief
Executive Officer, President and Chief Medical Officer, Galectin
Therapeutics. "This Phase 1 first-in-man study is evaluating the
safety, tolerability, pharmacokinetics 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."
The Company also is working with Providence Portland Medical
Center in planning for an investigator sponsored Phase 1 clinical
trial to evaluate the combination of Bristol-Myers Squibb's Yervoy®
(ipilimumab) and the Company's GR-MD-02 in patients with metastatic
melanoma. This trial is based on pre-clinical data obtained in
collaboration with Dr. Will Redmond at the center which
demonstrated that the combination of immune checkpoint inhibitors
like ipilimumab with GR-MD-02 enhances the antitumor effect in
syngeneic mouse cancer models. This trial recently was
approved by the FDA and expected to commence in the second quarter
of 2014.
At December 31, 2013, the Company had $10.5 million of
non-restricted cash and cash equivalents available to fund future
operations. In January and February 2014, the Company received $1.5
million from warrant exercises and $28.2 million in net proceeds
from the issuance of common shares through its At Market stock
issuance program. The Company believes that the cash on hand of
$37.6 million as of March 21, 2014, is sufficient to fund its
currently planned operations and research and development through
2015.
For the year ended December 31, 2013, the Company reported a net
loss applicable to common stock of $21.9 million, or ($1.30) per
share, basic and diluted, compared with a net loss applicable to
common stock of $10.9 million or ($0.72) per share, basic and
diluted, for 2012. The increase in net loss applicable to
common stock is largely due to an $8.8 million or ($0.53) per share
one-time, non-cash charge related to 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.
Research and development expense for the 2013 was $5.7 million,
compared with $4.5 million for 2012. The increase in research
and development expense in 2013 over 2012 primarily relates to
increased costs for our Phase I clinical trial offset somewhat by
lower pre-clinical and drug manufacturing costs.
General and administrative expense for 2013 was $6.4 million,
compared with $5.4 million for 2012. The primary reasons for the
increase were non-cash stock-based compensation and legal expense
offset somewhat by decreased rent expense.
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 clinical trials, including
our expectation that clinical data from the first cohort should be
available in April 2014, the Company's plans regarding a Phase 1
clinical trial to evaluate the combination of Bristol-Myers
Squibb's Yervoy® (ipilimumab) and the Company's GR-MD-02 in
patients with metastatic melanoma, and plans regarding future
funding alternatives and the sufficiency of cash on hand to fund
future operations and planned research and development through
2015. 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 any clinical trial or any future trials are
subject to factors beyond our control and there is no guarantee
that we will avoid delays in the development of our drug products
or receive FDA approval for any of our drugs in development. Any
current clinical trials and any future trials may not produce
positive results in a timely fashion, if at all, and any necessary
changes during the course of a 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 any proposed indications. 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 December 31, 2013, 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 registered
trademark of Galectin Therapeutics Inc.
Yervoy® is a registered trademark of Bristol-Myers Squibb
Condensed Consolidated
Statements of Operations |
|
|
|
|
Year
Ended |
|
December 31, |
|
2013 |
2012 |
|
(in thousands, except |
|
per share data) |
Operating expenses: |
|
|
|
|
|
Research and
development |
$5,688 |
$4,527 |
General and
administrative |
6,416 |
5,372 |
Total operating
expenses |
12,104 |
9,899 |
Total operating
loss |
(12,104) |
(9,899) |
Other income: |
|
|
Interest and other |
16 |
224 |
Total other
income |
16 |
224 |
Net loss |
$(12,088) |
$ (9,675) |
Preferred stock dividends and accretion
costs |
(1,096) |
(1,206) |
Modification of warrants |
(8,763) |
-- |
Net loss applicable to common
stock |
$(21,947) |
$(10,881) |
Basic and diluted net loss per
share |
$ (1.30) |
$ (0.72) |
Shares used in computing basic and diluted
net loss per share |
16,874 |
15,131 |
|
|
|
Condensed Consolidated
Balance Sheet Data |
|
|
|
|
December 31, |
December 31, |
|
2013 |
2012 |
|
(in
thousands) |
Cash and cash equivalents |
$ 10,489 |
$ 9,364 |
Total assets |
10,713 |
9,561 |
Total current liabilities |
2,486 |
1,638 |
Total liabilities |
2,486 |
1,644 |
Total redeemable, convertible preferred
stock |
6,746 |
6,752 |
Total stockholders' equity |
$ 1,481 |
$ 1,165 |
CONTACT: Jack Callicutt,
Chief Financial Officer,
678-620-3186,
ir@galectintherapeutics.com
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