Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for the three months ended June 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.
“Our major program in treating patients with NASH
cirrhosis with our galectin-3 inhibitor GR-MD-02 is progressing
very well,” said Peter G. Traber, M.D., president, chief executive
officer and chief medical officer of Galectin Therapeutics.
“The DSMB (data safety monitoring board) concluded its third review
of the safety and conduct of our trial and we were lauded for both
the manner in which this trial is being conducted as well as its
safety profile. Over 99% of the doses have already been
administered. The dropout rate remains well below
expectations, which may increase the power of the trial. We
currently expect approximately 151 subjects will complete the trial
by September 2017, which will give the study a power of over 95% to
detect a difference if there is one. After completion of
tests to determine the study endpoints and initial analysis of
data, we are on track to report top line data in early December
2017.”
Summary of Key Development Programs and
Updates
- As of August 11, 2017, 130 patients (80%) have completed all 52
weeks of infusions in the Company’s NASH-CX Phase 2b Clinical
Trial. Approximately 99% of the entire study’s total number
of infusions have been administered.
- Announced that in June, the DSMB concluded that, from a safety
perspective, the Company's NASH-CX trial should continue. As of the
time of their evaluation, therapy had been completed in 68% of
subjects in the NASH-CX trial. The feedback from the committee to
the Company was positive, with the panel congratulating the company
for a trial that has run very smoothly.
- Company remains on track to report top line data from the
NASH-CX Phase 2b Clinical Trial in December 2017.
- Company is funded through January 2018, which is sufficient to
report top line data of the NASH-CX Phase 2b Clinical Trial.
- Received notice of allowance for a U.S. Patent for
“Galacto-Rhamnogalacturonate compositions for the treatment of a
number of diseases associated with elevated inducible nitric oxide
synthase” (iNOS). The patent's principal claims cover method of use
for GR-MD-02 in a broad category of diseases in which there is an
inflammatory response characterized by an increase in the enzyme
iNOS.
- Issued U.S. Patent 9,649,327 for "Composition of
Novel Carbohydrate Drug for Treatment of Human Diseases." The
patent's principal claims cover method of use for GR-MD-02 in
patients with an autoimmune disease. The breadth of coverage for
the patent portfolio includes; various types of organ fibrosis
(liver, lung, kidney), non-alcoholic steatohepatitis, kidney
disease, and cancer, including combination cancer
immunotherapy. This method of use patent protects the use of
GR-MD-02 in the general category of autoimmune disease, which
covers multiple types of human diseases and strengthens our other
patents.
- In partnership with the Providence Cancer Center, progressed
our combination cancer immunotherapy program. The Phase 1b
clinical trial that combines GR-MD-02 with pembrolizumab
(KEYTRUDA®) continues to enroll patients and recently completed the
second cohort, which used 4 mg/kg GR-MD-02. The third cohort, which
will start 85 days following the final patient enrollment in the
second cohort, will enroll 10 patients at a dose of 8 mg/kg
GR-MD-02. There will likely be additional data reported in early
2018.
- As of June 2017, completed the 24-week Phase 1 study in three
patients with severe atopic dermatitis, with the last 12 weeks at
the increased dose of 12 mg/kg. All three patients had
approximately 50% improvement in their atopic dermatitis disease
scores, with no increased improvement at the higher dose.
- Launched the Liver Line, an online community and
publication on liver health and liver disease, which has already
had 95,000 readers.
Management Commentary
“Many NASH trials are focused on NASH Stages I, II,
and III, while our NASH-CX trial is focused on NASH cirrhosis
(Stage IV), the only stage of NASH where it is believed an
effective treatment can halt the progression of, or reverse,
existing fibrosis. This would represent a breakthrough therapeutic
intervention that may prevent complications, alleviate the need for
liver transplant, and even save lives. We are pleased that our
Phase 2b trial in NASH cirrhosis is fully enrolled as there are
other NASH clinical trials that have reported challenges meeting
their original enrollment goals. Some trials have even had to
modify the veracity of their clinical endpoints, all of which makes
the imminent reporting of our top line results in December that
much more important. It is also reassuring to hear the
independent DSMB laud our CX trial for the safe, consistent and
efficient manner in which it is being conducted. This trial
was designed, and is being conducted, with a primary endpoint that
the U.S. Food and Drug Administration views may be a
surrogate for outcomes for registration trials in this patient
population.”
"In this past quarter, we have received new patents
that have extended the intellectual property protection of GR-MD-02
into multiple potential disease indications. For instance, we
recently received a patent extending claims to a wide-range of
diseases with an inflammatory response and another patent for the
use of GR-MD-02 in patients with an autoimmune disease. The
breadth of coverage for the patent portfolio includes; various
types of organ fibrosis (liver, lung, kidney), non-alcoholic
steatohepatitis, kidney disease, and cancer, including combination
cancer immunotherapy. In particular, our combination cancer
immunotherapy method of use patent protects the use of GR-MD-02 in
the general category of autoimmune disease which covers multiple
types of human diseases and strengthens our other patents.
Galectin Therapeutics has additional patent applications
pending, both domestically in the United States, as well as in a
number of international markets.”
“Liver Line is a central, online gathering
place we have built for patients, medical professionals and
researchers to learn about the latest developments in liver health
and the treatment of diseases such as non-alcoholic steatohepatitis
(NASH), liver fibrosis, and cirrhosis. This online community
is an educational effort to ensure important stakeholders in drug
development and research in NASH have access to the most up to date
information. Most people don’t realize liver health is as important
as heart health, and informing primary-care physicians is key, as
they are on the front lines of liver health. Since its launch
in May, Liver Line has reached over 95,000 readers and was
featured as a model campaign to raise awareness of liver disease in
The Wall Street Journal.”
“While our main focus continues to be on the
NASH-CX trial, we are also supporting parallel trials in skin
disease and cancer where we have evidence that GR-MD-02 could have
a therapeutic effect. Many organizations throughout the
pharmaceutical industry have taken notice and informally shown
interest in our trails. Our team is dedicated to demonstrating the
value of our proprietary molecule, GR-MD-02, and will continue to
conduct our trials, while also exploring additional uses that have
the potential to enlarge our growth prospects.”
Financial Results
For the three months ended June 30, 2017, the
Company reported a net loss applicable to common stockholders of
$4.8 million, or $0.14 per share, compared with a net loss
applicable to common stockholders of $5.8 million, or $0.20 per
share, for the three months ended June 30, 2016. The decrease is
largely due to lower research and development expenses primarily
related to pre-clinical and drug manufacturing and to lower stock
compensation expenses.
Research and development expense for the three
months ended June 30, 2017 was $3.4 million, compared with $4.2
million for the three months ended June 30, 2016. The decrease
primarily relates lower research and development expenses primarily
related to pre-clinical and drug manufacturing.General and
administrative expense for quarter was $1.0 million, compared with
$1.3 million for the prior year, with the decrease being primarily
related to lower investor relations and non-cash stock compensation
expenses.
As of June 30, 2017, the Company had $9.1 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
TherapeuticsGalectin 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 June
30, |
Six Months Ended
June 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
Research and development |
$ |
3,444 |
|
$ |
4,226 |
|
$ |
7,216 |
|
$ |
8,603 |
|
General and administrative |
|
1,070 |
|
|
1,305 |
|
|
2,244 |
|
|
3,742 |
|
Total operating expenses |
|
4,514 |
|
|
5,531 |
|
|
9,460 |
|
|
12,345 |
|
Total
operating loss |
|
(4,514 |
) |
|
(5,531 |
) |
|
(9,460 |
) |
|
(12,345 |
) |
Other
income: |
|
|
|
|
Interest and other |
|
6 |
|
|
12 |
|
|
15 |
|
|
26 |
|
Total other income |
|
6 |
|
|
12 |
|
|
15 |
|
|
26 |
|
Net
loss |
$ |
(4,508 |
) |
$ |
(5,519 |
) |
$ |
(9,445 |
) |
$ |
(12,319 |
) |
Preferred stock dividends and accretion costs |
|
(301 |
) |
|
(308 |
) |
|
(573 |
) |
|
(518 |
) |
Net loss applicable to common stock |
$ |
(4,809 |
) |
$ |
(5,827 |
) |
$ |
(10,018 |
) |
$ |
(12,837 |
) |
Basic
and diluted net loss per share |
$ |
(0.14 |
) |
$ |
(0.20 |
) |
$ |
(0.29 |
) |
$ |
(0.44 |
) |
Shares used in computing basic and diluted net loss per share |
|
34,692 |
|
|
29,023 |
|
|
34,312 |
|
|
29,001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Data
|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
(in thousands) |
Cash and
cash equivalents |
$ |
9,127 |
$ |
15,362 |
Total
assets |
|
9,329 |
|
15,795 |
Total
current liabilities |
|
3,512 |
|
3,780 |
Total
liabilities |
|
3,512 |
|
3,780 |
Total
redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
Total
stockholders’ equity |
$ |
4,094 |
$ |
10,292 |
|
|
|
|
|
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com.
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