Galectin Therapeutics Reports 2017 Third Quarter Financial Results and Provides Business Update
November 07 2017 - 8:15AM
All 52 weeks of infusions and 100% of the doses
have been administered in the NASH Cirrhosis, NASH-CX Phase 2b
Clinical Trial Top Line Results of NASH-CX Phase 2b Clinical Trial
Expected to be announced in early December 2017
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for the three months ended September 30, 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.
“All of the patients in our NASH Cirrhosis, NASH-CX
Phase 2b Clinical Trial have completed all 52 weeks of infusions
and 100% of the doses have been administered,” said Peter G.
Traber, M.D., president, chief executive officer and chief medical
officer of Galectin Therapeutics. “The dropout rate was well
below expectations, with 151 subjects out of the 162 enrolled
having completed the full trial regimen. The data will be
compiled and analyzed in expectation that we will meet our original
target of reporting top line data in early December 2017.”
Expected Upcoming Milestones
- Company remains on track to report top line data from the
NASH-CX Phase 2b Clinical Trial in December 2017.
Summary of Key Development Programs and
Updates
- Company is funded through February 2018, which is sufficient to
report top line data of the NASH-CX Phase 2b Clinical Trial.
- Dr. Peter G. Traber, M.D., the Company’s president, chief
executive officer and chief medical officer was Chair of the
Conference for NASH Summit Europe 2017, an industry
nonalcoholic steatohepatitis (NASH) drug development forum that was
held in Frankfurt, Germany from October 10-12, 2017.
- The Company received a Decision to Grant from the Chinese
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 coverage of the
Company's lead compound, GR-MD-02, to China, where the
prevalence of fatty liver disease has approximately doubled over
the past two decades, with around 15% of the population
experiencing NASH.
Financial Results
For the three months ended September 30, 2017,
the Company reported a net loss applicable to common stockholders
of $4.7 million, or $0.13 per share, compared with a net loss
applicable to common stockholders of $4.5 million, or $0.16 per
share, for the three months ended September 30, 2016. The decrease
is largely due to lower general and administrative expenses and to
lower stock compensation expenses. Research and development expense
for the three months ended September 30, 2017 was $3.5 million,
compared with $3.3 million for the three months ended September 30,
2016. The increase primarily is primarily related to higher
pre-clinical and drug manufacturing expenses. General and
administrative expense for quarter was approximately $900,000,
compared with $1.2 million for the prior year, with the decrease
being primarily related to lower investor relations and non-cash
stock compensation expenses. As of September 30, 2017, the Company
had $7.0 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.
Contacts:Jack Callicutt, Chief Financial
Officer(678) 620-3186ir@galectintherapeutics.com
Galectin Therapeutics and its associated logo is
a registered trademark of Galectin Therapeutics Inc.
Condensed Consolidated Statements of
Operations
|
Three Months EndedSeptember
30, |
Nine Months
EndedSeptember 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
Research and development |
$ |
3,503 |
|
$ |
3,289 |
|
$ |
10,719 |
|
$ |
11,892 |
|
General and administrative |
|
911 |
|
|
1,248 |
|
|
3,155 |
|
|
4,990 |
|
Total operating expenses |
|
4,414 |
|
|
4,537 |
|
|
13,874 |
|
|
16,882 |
|
Total operating loss |
|
(4,414 |
) |
|
(4,537 |
) |
|
(13,874 |
) |
|
(16,882 |
) |
Other
income: |
|
|
|
|
Interest and other |
|
6 |
|
|
11 |
|
|
21 |
|
|
37 |
|
Total other income |
|
6 |
|
|
11 |
|
|
21 |
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(4,408 |
) |
$ |
(4,526 |
) |
$ |
(13,853 |
) |
$ |
(16,845 |
) |
Preferred stock dividends and accretion costs |
|
(254 |
) |
|
(119 |
) |
|
(827 |
) |
|
(639 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock |
$ |
(4,662 |
) |
$ |
(4,645 |
) |
$ |
(14,680 |
) |
$ |
(17,484 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
$ |
(0.13 |
) |
$ |
(0.16 |
) |
$ |
(0.42 |
) |
$ |
(0.60 |
) |
Shares used in computing basic and diluted net loss per share |
|
35,165 |
|
|
29,282 |
|
|
34,600 |
|
|
29,045 |
|
Condensed Consolidated Balance Sheet
Data
|
|
September 30, |
|
December 31, |
|
|
2017 |
|
2016 |
|
|
(in thousands) |
Cash and
cash equivalents |
$ |
6,958 |
$ |
15,362 |
Total
assets |
|
7,011 |
|
15,795 |
Total
current liabilities |
|
4,341 |
|
3,780 |
Total
liabilities |
|
4,341 |
|
3,780 |
Total
redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
Total
stockholders’ equity |
$ |
947 |
$ |
10,292 |
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