Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for the year ended December 31, 2016. 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.
Galectin Therapeutics management will host a
conference call at 9:00 a.m. Eastern time March 28, 2017 to discuss
this press release.
To access the conference call dial 844-899-6544
and provide the operator with Pin Number 89964111.
Galectin also invites all interested parties to
listen to its conference call via webcast at
http://edge.media-server.com/m/p/exukm2jh. The webcast will also be
available on the investor relations portion of the Company’s
website at http://galectintherapeutics.com/. The webcast will be
archived on the Company’s website within two hours of the live
call. The webcast will be available on the Company’s website at
www.galectintherapeutics.com for 90 days.
Management Commentary“Galectin
Therapeutics achieved a number of significant milestones in the
development of our lead compound, GR-MD-02, during 2016,” said
Peter G. Traber, M.D., president, chief executive officer and chief
medical officer of Galectin Therapeutics. “Furthermore, we’ve
recently completed equity financings that have generated sufficient
funding to cover currently planned expenditures through 2017.
"While non-alcoholic steatohepatitis (NASH)
cirrhosis remains GR-MD-02’s primary disease target, a number of
additional trials have provided encouraging early results that
provide additional insight on the clinical effect of
GR-MD-02. In total, what we have seen in our early trials in
moderate-to-severe plaque psoriasis and severe atopic dermatitis
have consistently shown that GR-MD-02 demonstrates clinically
significant, biological activity in humans.
“NASH cirrhosis represents a large unmet medical
need with no currently approved therapies, and we are very pleased
with our progress in the NASH-CX trial. A drug that can halt
progression of, or reverse existing fibrosis, in NASH cirrhosis
patients would be a breakthrough therapeutic intervention that may
prevent complications, alleviate the need for liver transplant, and
even prevent death.
“Our Phase 2b NASH-CX clinical trial enrollment
exceeded its target and, to date, 71 patients have completed all 52
weeks of infusions with GR-MD-02, and 155 patients have completed
26 weeks of infusions. More than 3,400 infusions (or 85% of the
maximum infusions in the trial) have been administered, with no
drug-related serious adverse reactions and a dropout rate that is
below the rate included in the trial design. The top-line
data readout of the NASH-CX trial remains on track for early
December 2017.
“The Providence Cancer Center is continuing two
investigator-initiated Phase 1 clinical trials of GR-MD-02 used in
combination with approved immunotherapies, Yervoy® and Keytruda® in
patients with advanced melanoma, oral/head and neck cancer (OHN)
and non-small cell lung cancer (NSCLC). There have been no safety
concerns in either of these studies. Of the five patients with
advanced melanoma who underwent combination therapy with GR-MD-02
(2 mg/kg) and Keytruda®, one had an impressive partial response,
heading towards a complete response, and one had a mixed
response.
“Galectin Therapeutics also announced positive
results in studies of GR-MD-02 for patients with serious skin
diseases. This is an encouraging new indication for GR-MD-02 and
one of the previously mentioned demonstrations that the drug is
biologically active in humans.
“A Phase 2, exploratory study of GR-MD-02 in
patients with severe plaque psoriasis showed all five patients
enrolled had significant clinical improvement (mean of 52%
improvement) as measured by an objective measurement, the PASI
(Psoriasis Area and Severity Index). After receiving 8 mg/kg doses
of GR-MD-02 for up to 24 weeks, the fifth patient, who also had the
most severe baseline disease, had an 82% PASI improvement
approximately one month following the full thirteen infusions (24
weeks).
“In an investigator-initiated protocol, GR-MD-02
was also used to treat three adult patients with severe atopic
dermatitis, each of whom had been recalcitrant to multiple
therapies over many years. All three patients have had a marked
clinical effect with near resolution of pruritus, or itching, and
regression of skin lesions. Two patients achieved a 64% and
74% reduction in Eczema Area and Severity Index (EASI), after only
6 weeks and 3 drug infusions. These findings are believed to
demonstrate a clinically significant effect of this novel
investigational drug in this patient population.”
“In summary, we believe that Galectin is in a
solid position from clinical, financial and leadership
perspectives,” Dr. Traber concluded.
Financial Results
For the year ended December 31, 2016, the
Company reported a net loss applicable to common stockholders of
$22.4 million, or $0.76 per share, compared with a net loss
applicable to common stockholders of $21.1 million, or $0.88 per
share, for 2015. The increase is largely due to higher
research and development expenses primarily related to the Phase 2
clinical program.
Research and development expense for 2016 was
$15.3 million, compared with $13.1 million for 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 2016 was
$6.2 million, compared with $7.0 million for 2015, primarily due to
a decrease in stock based compensation.
As of December 31, 2016, the Company had $15.4
million of non-restricted cash and cash equivalents. In January and
February 2017, the Company raised a total of $1.5 million in net
proceeds from issuance of common stock. 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 which 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 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, 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.
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, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
$ |
15,325 |
|
|
$ |
13,114 |
|
General and administrative |
|
|
6,156 |
|
|
|
6,965 |
|
Total operating expenses |
|
|
21,481 |
|
|
|
20,079 |
|
Total operating loss |
|
|
(21,481 |
) |
|
|
(20,079 |
) |
Other
income: |
|
|
|
Interest and other |
|
|
45 |
|
|
|
52 |
|
Total other income |
|
|
45 |
|
|
|
52 |
|
Net
loss |
|
$ |
(21,436 |
) |
|
$ |
(20,027 |
) |
Preferred stock dividends and accretion costs |
|
|
(914 |
) |
|
|
(1,097 |
) |
Net loss applicable to common stock |
|
$ |
(22,350 |
) |
|
$ |
(21,124 |
) |
Basic
and diluted net loss per share |
|
$ |
(0.76 |
) |
|
$ |
(0.88 |
) |
Shares used in computing basic and diluted net loss per share |
|
|
29,216 |
|
|
|
24,120 |
|
Condensed Consolidated Balance Sheet
Data |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,2016 |
|
|
|
|
December 31,2015 |
|
|
|
|
(in thousands) |
Cash and
cash equivalents |
|
|
$ |
15,362 |
|
|
|
$ |
25,846 |
Total
assets |
|
|
|
15,795 |
|
|
|
|
26,408 |
Total
current liabilities |
|
|
|
3,780 |
|
|
|
|
1,360 |
Total
liabilities |
|
|
|
3,780 |
|
|
|
|
1,360 |
Total
redeemable, convertible preferred stock |
|
|
|
1,723 |
|
|
|
|
7,008 |
Total
stockholders’ equity |
|
|
$ |
10,292 |
|
|
|
$ |
18,040 |
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com.
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