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, 2015. 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 and is available at www.sec.gov.
Management Commentary
“Numerous clinical advancements during 2015 with
our lead compound GR-MD-02 form the basis for a productive 2016,
and we look forward to reporting on a number of important
development milestones throughout the year,” said Peter G. Traber,
M.D., president, chief executive officer and chief medical officer
of Galectin Therapeutics. “Of particular note, during 2015 we
began two Phase 2 studies with GR-MD-02 in non-alcoholic
steatohepatitis, or NASH, a disease that has been gaining
considerable awareness not only among clinicians, but also among
the general population. NASH is a significant and growing problem,
and treatment will require considerable healthcare resources.
Our compound is being investigated in NASH with cirrhosis in our
NASH-CX trial, and in NASH with advanced fibrosis in our NASH-FX
trial. We expect to report top-line data from our NASH-FX
trial by the end of September of this year. Enrollment in our
NASH-CX trial is on schedule and we expect to report top-line data
by the end of 2017. We are very excited about the potential
for GR-MD-02 in the treatment paradigm of a global market estimated
to reach $35 billion by the middle of the next decade.”
Dr. Traber continued, “In addition to data from
the NASH-FX trial, we expect to report data from a 10-patient Phase
2 open-label study with GR-MD-02 in moderate-to-severe plaque
psoriasis in September 2016. Also, our partners at the Providence
Portland Cancer Center are studying GR-MD-02 in combination with
the checkpoint inhibitors Yervoy® and Keytruda® in two separate
Phase 1b studies in advanced metastatic melanoma. We look
forward to initial data from select cohorts in both studies later
this year, but are dependent on the Providence Portland Cancer
Center to conduct and fund these trials. Preclinical work in cancer
models with GR-MD-02 added to checkpoint inhibitors showed a boost
in anti-tumor immunity, a reduction in tumor size and increased
survival, and we are eager to learn if this activity will be
duplicated in humans.
“We strengthened our U.S. patent position during
2015 and more recently obtained an extension of coverage for method
of use patents of pectin compounds in a number of fibrotic
diseases, including pulmonary fibrosis. We are formulating plans to
leverage our intellectual property. Also in recent weeks we
named lead independent director Marc Rubin, M.D. as chairman of our
board of directors. Dr. Rubin is a leading bioscience industry
executive with more than 25 years of senior management and board
experience in the development and commercialization of
pharmaceuticals.
“In January 2016, we announced that the United
States District Court for Northern Georgia had dismissed all claims
against it and certain officers, directors and shareholder 10X Fund
L.P. alleged in a Consolidated Securities Class Action originally
filed in July 2014 and all claims against certain officers and
directors alleged in a Consolidated Shareholder Derivative Action
originally filed in August 2014. The Court entered final
judgments of dismissals in both actions, that is, dismissals 'with
prejudice,' based on the Court’s finding that any further amendment
of the complaints would be futile. Plaintiffs have filed
notice of intent to appeal in both matters. On March 3,
2016, the Nevada State Court dismissed a shareholder derivative
complaint filed against the Company’s officers and directors in
Nevada and entered a final judgment in favor of the
defendants. The plaintiff has 30 days to appeal after the
final judgment order. We are pleased that these matters
appear very close to final resolution in favor of the Company and
our officers and directors."
“In summary, we believe that Galectin is in a
solid position from clinical, financial and leadership
perspectives. I look forward to continuing consistent
outreach to the investment community via frequent CEO Perspective
blog postings and conference participation, among other activities
to keep our shareholders informed of our plans, accomplishments and
milestones,” Dr. Traber concluded.
Financial
Results
For the year ended December 31, 2015, the
Company reported a net loss applicable to common stockholders of
$21.1 million, or $0.88 per share, compared with a net loss
applicable to common stockholders of $17.0 million, or $0.78 per
share, for 2014. The increase is largely due to higher
research and development expenses primarily related to the Phase 2
clinical program.
Research and development expense for 2015 was
$13.1 million, compared with $8.4 million for 2014. The
increase primarily relates to costs for the Phase 2 clinical trials
begun in 2015, partially offset by lower preclinical costs.
General and administrative expense for 2015 was
$7.0 million, compared with $7.0 million for 2014.
As of December 31, 2015, the Company had $25.8
million of non-restricted cash and cash equivalents. The Company
believes it has sufficient cash to fund currently planned
operations and research and development activities through March
31, 2017.
Conference Call and Webcast
Galectin Therapeutics management will host a
conference call at 8:30 a.m. Eastern time today to provide a
business update and discuss fourth quarter financial results.
To access the conference call, U.S.-based
listeners should dial 844-236-5620 and international listeners
should dial 330-863-3454. All listeners should provide the
following passcode: 65873987. Individuals interested in listening
to the live conference call via the Internet may do so by logging
on to the Company’s website at www.galectintherapeutics.com.
Following the conclusion of the conference call,
a replay will be available through March 21, 2016 and can be
accessed by dialing (855) 859-2056 from within the U.S. or (404)
537-3406 from outside the U.S. All listeners should provide
passcode 65873987. The webcast will be available on the Company’s
website at www.galectintherapeutics.com for 90 days.
About Galectin
TherapeuticsGalectin Therapeutics is developing promising
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 StatementsThis
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 and those regarding the hope that our lead
compounds will be successful in connection with cancer
immunotherapy. 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; 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, 2015, 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.
Contacts: Jack Callicutt, Chief Financial Officer (678)
620-3186 ir@galectintherapeutics.com
or
LHA Kim Golodetz (212) 838-3777 kgolodetz@lhai.com
Galectin Therapeutics and its associated logo is
a registered trademark of Galectin Therapeutics Inc.
Yervoy® is a registered trademark of
Bristol-Myers Squibb
Keytruda® is a registered trademark of Merck
& Co.
Condensed Consolidated Statements of
Operations
|
Year Ended December
31, |
|
|
2015 |
|
|
2014 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
Research and development |
$ |
13,114 |
|
$ |
8,425 |
|
General and administrative |
|
6,965 |
|
|
7,005 |
|
Total operating expenses |
|
20,079 |
|
|
15,430 |
|
Total operating loss |
|
(20,079 |
) |
|
(15,430 |
) |
Other
income: |
|
|
Interest and other |
|
52 |
|
|
(358 |
) |
Total other income |
|
52 |
|
|
(358 |
) |
Net
loss |
$ |
(20,027 |
) |
$ |
(15,788 |
) |
Preferred stock dividends and accretion costs |
|
(1,097 |
) |
|
(1,172 |
) |
Net loss applicable to common
stock |
$ |
(21,124 |
) |
$ |
(16,960 |
) |
Basic
and diluted net loss per share |
$ |
(0.88 |
) |
$ |
(0.78 |
) |
Shares used in computing basic and diluted net loss per share |
|
24,120 |
|
|
21,849 |
|
Condensed Consolidated Balance Sheet
Data
|
|
December 31, 2015 |
|
December 31, 2014 |
|
|
(in thousands) |
Cash and
cash equivalents |
$ |
25,846 |
$ |
29,128 |
Total
assets |
|
26,408 |
|
29,677 |
Total
current liabilities |
|
1,360 |
|
1,703 |
Total
liabilities |
|
1,360 |
|
1,703 |
Total
redeemable, convertible preferred stock |
|
7,008 |
|
6,779 |
Total
stockholders’ equity |
$ |
18,040 |
$ |
21,195 |
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