Top-line data from NASH-FX trial in NASH patients
with advanced fibrosis expected to be reported by the end of
September
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 three and six
months ended June 30, 2016. These results are included in the
Company’s 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, Updates and
Anticipated Milestones
- Completed recruitment in a Phase 2 clinical trial with GR-MD-02
in patients with non-alcoholic steatohepatitis (NASH) with
cirrhosis (stage 4) (the NASH-CX trial), wherein patient
recruitment was completed slightly ahead of our original
expectations
- Completed enrollment in Phase 2 clinical trial with GR-MD-02 in
patients with non-alcoholic steatohepatitis (NASH) with advanced
fibrosis (stage 3) (the NASH-FX trial)
- Positive preclinical results were presented at the American
Thoracic Society (ATS) 2016 International Conference in which
GR-MD-02 had shown a positive effect on vascular remodeling in an
animal model of pulmonary arterial hypertension (PAH)
- Presented interim results from an exploratory, open-label,
Phase 2a clinical trial with GR-MD-02 in patients with
moderate-to-severe plaque psoriasis in which patients showed
significant improvement in their plaque psoriasis
Management Commentary
“We are very pleased with the significant progress
achieved this quarter completing enrollment in two important
clinical trials, gaining further global protection of our
intellectual property, and presenting further evidence of the
positive effects of GR-MD-02 in new and exciting applications,”
said Peter G. Traber, M.D., president, chief executive officer and
chief medical officer of Galectin Therapeutics. “Most immediately,
with enrollment in our NASH-FX trial in NASH patients with advanced
fibrosis (stage 3) having been completed on schedule in May, we are
on pace to report top-line data assessing the efficacy of GR-MD-02
by the end of September. And, with recruitment also completed for
our Phase 2 NASH-CX trial, we will be able to assess the efficacy
of GR-MD-02 in up to 156 patients with non-alcoholic
steatohepatitis (NASH) with cirrhosis. Patient recruitment for this
trial was completed slightly ahead of our original expectations and
we anticipate to report top line results in December 2017, as
previously planned.” With its NASH trials investigating liver
applications, Galectin is also exploring other applications of its
lead compound. This quarter, the Company received encouraging
results on two early stage studies. In an early stage investigation
of applicability to vascular remodeling in pulmonary arterial
hypertension (PAH), investigators from the Vascular Biology Center
and the Department of Pharmacology and Toxicology at Augusta
University presented data at the American Thoracic Society (ATS)
2016 International Conference, in which GR-MD-02 had shown a
positive effect in an animal model of PAH. David Fulton, Ph.D.,
director of the Vascular Biology Center at Augusta University,
noted that the alterations in cardiopulmonary function and vascular
proliferation, as well as in fibrosis were significantly attenuated
by in vivo treatment with specific gal-3 inhibitors, with our lead
compound obviously being a gal-3 inhibitor.
Separately, interim results from an exploratory,
open-label, Phase 2a clinical trial with GR-MD-02 in patients with
moderate-to-severe plaque psoriasis, in which four patients who
received 12 weeks of therapy had significant improvement in their
plaque psoriasis, led to the extension of the treatment duration to
24 weeks. These interim results demonstrate a potentially important
clinical effect of GR-MD-02 in clearing moderate-to-severe plaque
psoriasis.
In the quarter, the Company also received Notice of
Allowance from the Australian Government Patent Office for patent
application for "Composition of Novel Carbohydrate Drug for
Treatment of Human Diseases" that, from the date they are issued
and through 2032, will extend coverage of GR-MD-02 to Australia to
treat patients at risk of non-alcoholic steatohepatitis (NASH),
fibrosis, inflammatory and autoimmune disorders in which galectins
are at least in part involved. The allowance of these claims
further strengthens the protection of the intellectual property
behind GR-MD-02. This is but one of more than 50 patent
applications the Company has pending in 10 foreign countries, all
of which are viewed as significant markets for the active
pharmaceutical ingredient (API) or the manufacture of the API. When
issued, this patent will augment Galectin’s current intellectual
property portfolio for treatment of liver fibrosis, kidney
fibrosis, lung fibrosis or heart fibrosis. The
investigator-sponsored trials utilizing GR-MD-02 in combination
with checkpoint inhibitors being conducted by Galectin’s partners
at the Providence Portland Cancer Center, who are also funding the
studies, continue to advance. The study of GR-MD-02 in combination
with Yervoy® and Keytruda® in two separate Phase 1b trials in
patients with metastatic melanoma is expected to yield data from
the Yervoy combination trial by the end of the year.”
Galectin Therapeutics is exhibiting a steady
pattern of progress throughout and across the organization not only
with its primary investigations, but in new and evolving
applications as well. As such, its addressable market increases
from the still very large $35 billion, understood to be available
just from the treatment of NASH, to an even larger sum when
considering psoriasis, PAH and potentially other maladies. Each of
these efforts is based on a very systematic approach to advancing
development whereby Galectin is moving methodically along the
development path while simultaneously branching out into adjacent
and complementary markets whenever the science warrants a new
investigation. Allied with very strong medical professionals who
are conducting these trials and investigations, Galectin’s
management team is doing everything within its power to optimize
the value of the organization, its intellectual property, and the
other assets at its disposal.
Financial
Results
For the three months ended June 30, 2016, the Company reported a
net loss applicable to common stockholders of $5.8 million, or
$0.20 per share, compared with a net loss applicable to common
stockholders of $4.9 million, or $0.21 per share, for the three
months ended June 30, 2015. The increase is largely due to higher
research and development expenses primarily related to the Phase 2
clinical program in NASH.
Research and development expense for the three months ended June
30, 2016 was $4.2 million, compared with $2.6 million for the three
months ended June 30, 2015. 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 quarter was $1.3 million,
compared with $2.1 million for the prior year, with the decrease
being to severance and non-cash stock compensation and lower legal
and accounting fees.
As of June 30, 2016, the Company had $18.0 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 June 30, 2017.
About Galectin Therapeutics Galectin
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 Statements This 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 current
or future 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.
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
|
|
|
|
|
|
Three Months Ended June
30, |
Six Months Ended June
30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
|
Research and development |
|
$ |
4,226 |
|
$ |
2,600 |
|
$ |
8,603 |
|
$ |
5,736 |
|
General and administrative |
|
|
1,305 |
|
|
2,057 |
|
|
3,742 |
|
|
3,761 |
|
Total operating expenses |
|
|
5,531 |
|
|
4,657 |
|
|
12,345 |
|
|
9,497 |
|
Total operating loss |
|
|
(5,531 |
) |
|
(4,657 |
) |
|
(12,345 |
) |
|
(9,497 |
) |
Other
income: |
|
|
|
|
|
Interest and other |
|
|
12 |
|
|
14 |
|
|
26 |
|
|
28 |
|
Total other income |
|
|
12 |
|
|
14 |
|
|
26 |
|
|
28 |
|
Net
loss |
|
$ |
(5,519 |
) |
$ |
(4,643 |
) |
$ |
(12,319 |
) |
$ |
(9,469 |
) |
Preferred stock dividends and accretion costs |
|
|
(308 |
) |
|
(288 |
) |
|
(518 |
) |
|
(536 |
) |
Net loss applicable to common
stock |
|
$ |
(5,527 |
) |
$ |
(4,931 |
) |
$ |
(12,837 |
) |
$ |
(10,005 |
) |
Basic
and diluted net loss per share |
|
$ |
(0.20 |
) |
$ |
(0.21 |
) |
$ |
(0.44 |
) |
$ |
(0.43 |
) |
Shares used in computing basic and diluted net loss per share |
|
|
29,023 |
|
|
23,731 |
|
|
29,001 |
|
|
23,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Data
|
|
|
|
|
|
|
|
|
June 30, 2016 |
|
December 31, 2015 |
|
|
|
(in thousands) |
Cash and
cash equivalents |
|
$ |
18,003 |
$ |
25,846 |
Total
assets |
|
|
18,247 |
|
26,408 |
Total
current liabilities |
|
|
3,636 |
|
1,360 |
Total
liabilities |
|
|
3,636 |
|
1,360 |
Total
redeemable, convertible preferred stock |
|
|
7,124 |
|
7,008 |
Total
stockholders’ equity |
|
$ |
7,487 |
$ |
18,040 |
|
|
|
|
|
|
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com.
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