Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for the three months ended March 31, 2017. These
results are included in the Company’s Quarterly Report on Form
10-Q, which has been filed with the U.S. Securities and Exchange
Commission and is available at www.sec.gov.
Summary of Key Development Programs and
Updates
- Received a Decision to Grant from the Japanese Patent
Office for its patent application for "Composition of Novel
Carbohydrate Drug for Treatment of Human Diseases," which, when
issued, will extend composition of matter patent coverage of the
Company's lead compound, GR-MD-02, to Japan through 2032.
- Presented a late-breaking abstract at The International Liver
Congress™ 2017 with data demonstrating the effectiveness of the
Exalenz 13C-Methacetin Breath Test (MBT) as a non-invasive test of
liver function.
- As of May 9, 2017, 92 patients have completed all 52 weeks of
infusions and 155 patients have completed 26 weeks of infusions in
the Company’s NASH-CX Phase 2b Clinical Trial. Approximately 92% of
the entire study’s total number of infusions have been
administered.
- Company remains on track to report top line data from the
NASH-CX trial in December 2017.
- Company is funded through the end of 2017, which is sufficient
to report top line data of NASH-CX.
Management Commentary
“Galectin Therapeutics continues to make steady
progress in the development of our lead compound, GR-MD-02, both in
our NASH-CX trial for NASH liver cirrhosis, as well as in related
ailments such as psoriasis and atopic dermatitis,” said Peter G.
Traber, M.D., president, chief executive officer and chief medical
officer of Galectin Therapeutics. “As was clearly demonstrated at
April’s International Liver Congress, NASH has become an area of
significant interest to the medical community, and Galectin is
currently the only company with a fully enrolled trial in NASH
cirrhosis, which is the most advanced stage of the disease. With
the NASH-CX trial on target to report top line data well before the
other two NASH cirrhosis trials underway, we are very pleased that
we addressed this growing epidemic early and are developing a
compound that is focused on a stage of NASH where an effective
treatment can halt the progression of, or reverse, existing
fibrosis, a breakthrough therapeutic intervention that may prevent
complications, alleviate the need for liver transplant, and even
save lives.”
“We are also very pleased to have continued to
expand our intellectual property protection on a global basis, most
recently in Japan, which was recently declared the second most
attractive drug market and third largest pharmaceutical market in
the world. We have 50 additional patent applications pending in 10
foreign countries.
“And, finally, in our efforts to help develop a
non-invasive test for diagnosing and following treatment of fatty
liver disease, NASH, and cirrhosis, we recently announced important
results of a study we sponsored that found that MBT non-invasively
detects clinically significant portal hypertension with high
sensitivity and specificity (CSPH, defined as HVPG ≥ 10 mmHg), a
main predictor of decompensation in NASH cirrhosis. Since the only
broadly accepted ways to currently assess a patient's condition is
via a liver biopsy or HVPG, both invasive tests with potential side
effects, a simple, non-invasive test that would enable us to
diagnose and track the progression of disease would significantly
benefit physicians and patients alike.
“Galectin continues to remain focused on the
NASH-CX trial, while also supporting and encouraging complementary
trials in skin disease and cancer. As is customary in our industry,
many organizations throughout the pharmaceutical industry have
shown interest in our trials, all strictly informal. More recently,
we have seen the increase in the number of NASH trials create new
challenges for the industry, such as the difficulty in finding
trial participants, which makes us feel fortunate with the timing
chosen to initiate and report on the NASH-CX trial. Our team is
dedicated to unlocking the value of our proprietary GR-MD-02
molecule and will continue to vigorously conduct our trials, while
also examining additional potential uses that could enlarge our
growth opportunity.
“Finally, we are pleased to highlight that Mr.
Richard Uihlein recently filed a Form 3 indicating an approximate
10% ownership in Galectin. Mr. Uihlein is long-time shareholder and
supporter of the Company, and we are fortunate to have such a
supportive investor with his means, interested in our
programs.”
Financial Results
For the three months ended March 31, 2017, the
Company reported a net loss applicable to common stockholders of
$5.2 million, or $0.15 per share, compared with a net loss
applicable to common stockholders of $7.0 million, or $0.24 per
share, for the three months ended March 31, 2016. The decrease is
largely due to lower pre-clinical research expenses and lower
non-cash stock based compensation expense in the three months ended
March 31, 2017, and also the three months ended March 31, 2016,
included a severance accrual and non-cash stock based compensation
related to the termination of the Company’s former executive
chairman.
Research and development expense for the three
months ended March 31, 2017, was $3.8 million, compared with $4.4
million for first quarter of 2016. The decrease primarily relates
to a reduction in preclinical research and drug manufacturing
costs.
General and administrative expense for the three
months ended March 31, 2017, was $1.2 million, compared with $2.4
million for first quarter of 2016, primarily due to the accrual for
severance and non-cash stock based compensation expense related to
the termination of the Company’s former executive chairman in
January 2016.
As of March 31, 2017, the Company had $13.6
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 December
31, 2017.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to
developing novel therapies to improve the lives of patients with
chronic liver and skin diseases and cancer. Galectin's lead drug
(GR-MD-02) is a carbohydrate-based drug that inhibits the
galectin-3 protein that is directly involved in multiple
inflammatory, fibrotic, and malignant diseases. The lead
development program is in non-alcoholic steatohepatitis (NASH) with
cirrhosis, the most advanced form of NASH related fibrosis. This is
the most common liver disease and one of the largest drug
development opportunities available today. Additional development
programs are in treatment of severe atopic dermatitis,
moderate-to-severe plaque psoriasis, and in combination
immunotherapy for advanced melanoma and other malignancies.
Galectin seeks to leverage extensive scientific and development
expertise as well as established relationships with external
sources to achieve cost-effective and efficient development.
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 the treatment of severe
atopic dermatitis, moderate-to-severe plaque psoriasis and in
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, 2016, 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.
|
Condensed Consolidated Statements of
Operations |
|
|
Three Months Ended March
31, |
|
|
2017 |
|
|
2016 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
Research and development |
$ |
3,772 |
|
$ |
4,377 |
|
General and administrative |
|
1,174 |
|
|
2,437 |
|
Total operating expenses |
|
4,946 |
|
|
6,814 |
|
Total operating loss |
|
(4,946 |
) |
|
(6,814 |
) |
Other
income: |
|
|
Interest and other |
|
9 |
|
|
14 |
|
Total other income |
|
9 |
|
|
14 |
|
Net
loss |
$ |
(4,937 |
) |
$ |
(6,800 |
) |
Preferred stock dividends and accretion costs |
|
(272 |
) |
|
(210 |
) |
Net loss applicable to common stock |
$ |
(5,209 |
) |
$ |
(7,010 |
) |
Basic
and diluted net loss per share |
$ |
(0.15 |
) |
$ |
(0.24 |
) |
Shares used in computing basic and diluted net loss per share |
|
33,928 |
|
|
28,827 |
|
Condensed Consolidated Balance Sheet Data |
|
|
|
March 31, 2016 |
|
December 31, 2016 |
|
|
(in thousands) |
Cash and
cash equivalents |
$ |
13,644 |
$ |
15,362 |
Total
assets |
|
13,997 |
|
15,795 |
Total
current liabilities |
|
4,362 |
|
3,780 |
Total
liabilities |
|
4,362 |
|
3,780 |
Total
redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
Total
stockholders’ equity |
$ |
7,912 |
$ |
10,292 |
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
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