Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for its third fiscal quarter, which ended
September 30, 2018, and provided a business update. 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.
Harold H. Shlevin, Ph.D., President and Chief
Executive Officer of Galectin Therapeutics, said, “Our central
focus remains advancing our plan for a Phase 3 clinical trial
program with GR-MD-02 in NASH cirrhosis, for which we continue to
make progress. Importantly, we have been collaborating with leading
NASH experts who have been enlisted to help strengthen the overall
plan. We are simultaneously scaling up manufacture of clinical
supplies and conducting other required activities prior to starting
the Phase 3 trial.
“In addition, we are pursuing other opportunities
where our galectin-3 inhibitor GR-MD-02 has demonstrated
encouraging clinical results. On September 20, 2018, we reported
that the investigators were encouraged by the reported Objective
Response Rate (ORR) of the GR-MD-02 and KEYTRUDA combination
immunotherapy trial for all cohorts relative to the ORR from
randomized studies with KEYTRUDA alone in patients with advanced
melanoma. The investigators also reported on six patients with head
and neck cancer that exhibited a 33% ORR and 67% Disease Control
Rate (DCR). As a result of these encouraging preliminary findings,
the investigators will be expanding the trial to include additional
patients. Further details are available in that press release. As a
company, we are very pleased with our productive collaboration with
Providence Cancer Institute.
“We continued to enhance the scope of our
intellectual property protections and expand basic patent approvals
in key markets and countries. During this quarter, we had the
following patents either granted or allowed:
- Galactose-pronged carbohydrate compounds for the treatment of
diabetic nephropathy and associated in Europe, Australia, and
China
- Composition of novel carbohydrate drug for treatment of human
disease in Japan
- Method for enhancing specific immunotherapies in China, Israel,
and Japan
- Compositions of novel carbohydrate drugs for treatment of NASH
and NAFLD in Mexico and South Africa
- We also note that patent applications have been filed on behalf
of Galectin Sciences LLC related to small molecule inhibitors of
galectin-3 and various other activities
“At quarter end, our funding is sufficient to
support continued pursuit of this multi-pronged strategy, all based
upon the strong foundation of our proprietary molecule and the
potential it represents. Our goal is to unlock the value of our
proprietary technology and capitalize on the pressing need for
solutions to the growing NASH epidemic and other diseases where our
anti-fibrotic compound can be therapeutic.”
Richard E. Uihlein, Chairman of the Board, added,
“This has been another quarter of steady progress across the broad
range of possibilities for GR-MD-02. I am pleased with the progress
Dr. Shlevin and the team are making and look forward to the
ultimate submission of our Phase 3 plan and the exciting
opportunities it can create.”
Summary of Key Development Programs and
Updates
- Continuing to develop plans for a Phase 3 clinical trial
program with our galectin-3 inhibitor GR-MD-02 in NASH cirrhosis,
incorporating advice and guidance obtained in a meeting with the
FDA and our external advisors. Details of the Phase 3 clinical
trial design, including projected timings and costs, will be
announced once the planning phase has been completed and the
Company has a final clinical trial protocol that is acceptable to
the FDA
- As highlighted above, in conjunction with Providence Cancer
Institute, announced additional preliminary clinical data from
cohort 3 of an investigator-initiated Phase 1b clinical trial of
GR-MD-02 used in combination with KEYTRUDA® (pembrolizumab) in
patients with metastatic melanoma for which KEYTRUDA is indicated
or those patients whose melanoma progressed during or recently
after KEYTRUDA monotherapy. Those results
indicated:• Combination immunotherapy of GR-MD-02 and KEYTRUDA
for all cohorts reported showed an Objective Response Rate of 50%
(seven of fourteen patients). These response rates from this small
cohort are encouraging as they were higher than expected with
KEYTRUDA alone• A Disease Control Rate of nine out of fourteen
patients (64%) with advanced melanoma, which the principal
investigator characterized as ‘very encouraging’• The
combination was also very well tolerated, and treatment appears to
be associated with fewer adverse events than expected with KEYTRUDA
alone• When aggregated with the cohorts previously reported,
the data shows a 50% Objective Response Rate in advanced melanoma
with GR-MD-02 in combination with KEYTRUDA whereas the published
response rate of KEYTRUDA alone is 33% in advanced
melanoma
- In addition to advanced melanoma patients, the Providence
Cancer Institute clinical trial enrolled six patients with head and
neck cancer in this Phase 1b trial with a 33% Objective Response
Rate and a 67% Disease Control Rate
- Providence Portland will be expanding the size of the 4 mg/kg
GR-MD-02 cohort including additional melanoma patients as well as
head and neck cancer patients. These results together with earlier
results will help guide decision on advancing development to Phase
2
- Back Bay Life Science Advisors, under contract with the
Company, continues to support the Company’s exploration of
strategic alternatives
Upcoming Scientific Presentations and
Conferences
- Dr. Harold H. Shlevin will be making a presentation, titled
“Physiological Control Systems Involving Galectins in the Treatment
of Diseases,” at the 2nd Annual Anti-Fibrotic Drug Development
Summit (AFDD) on November 29
- A poster presentation titled “The noninvasive point of care MBT
accurately predicts decompensation events better than MELD in
compensated (MELD<15) NASH cirrhotics” authored by Naga
Chalasani, et al. and based on results obtained from Galectin
Therapeutics’ NASH-CX Phase 2 Clinical Trial will be presented by
Exalenz Bioscience at The Liver Meeting, the annual meeting of the
American Association for the Study of Liver Diseases (AASLD) on
November 9-13, 2018. The poster illustrates Exalenz Bioscience’s
13C-Methacetin Breath Test’s (MBT) ability to predict
decompensation in compensated NASH cirrhotics
Other Activities
- Management participated with a number of other companies
pursuing a NASH therapy in the ROTH Capital Battle of the NASH
Thrones Investor Conference on October 17
- Dr. Harold H. Shlevin participated in the H.C.
Wainwright 20th Global Investment Conference on
September 6, 2018
Dr. Shlevin concluded, “Galectin Therapeutics
has developed a novel compound, GR-MD-02, a galectin-3 inhibitor,
which we believe has the potential to be effective in treating a
wide range of diseases wherein elevated levels of galectin protein
and inflammation play key roles in the pathophysiology of the
diseases. Most immediately, we are focused on advancing our Phase 3
trial in NASH Cirrhosis. However, we continue to investigate a
variety of other preclinical applications where research shows that
GR-MD-02’s antifibrotic capabilities may help provide more
effective treatment in a variety of conditions. We believe this is
the best path to build value in our overall galectin franchise and
maximize potential of this platform technology to treat other
diseases.” Financial Results
For the three months ended September 30, 2018, the
Company reported a net loss applicable to common stockholders of
$3.0 million, or $0.07 per share, compared with a net loss
applicable to common stockholders of $4.7 million, or $0.13 per
share, for the three months ended September 30, 2017. The decrease
is largely due to lower research and development expenses primarily
related to the winding down of the Phase 2 NASH clinical program
somewhat offset by higher non-cash stock compensation expenses.
Research and development expense for the three
months ended September 30, 2018, was $1.5 million, compared with
$3.5 million for the three months ended September 30, 2017. The
decrease primarily reflects lower research and development expenses
primarily related to the winding down of the Phase 2 NASH clinical
program somewhat offset by higher non-cash stock compensation
expenses.
General and administrative expense for the three
months ended September 30, 2018, was $1.2 million, compared with
$0.9 million for the three months ended September 30, 2017, with
the increase being primarily related to higher investor relations,
business development and non-cash stock compensation expenses.
As of September 30, 2018, the Company had $10.1
million of non-restricted cash and cash equivalents. The Company
believes current cash on hand and access to a $10 million line of
credit (unused at September 30, 2018) are sufficient to fund
currently planned operations and research and development
activities through at least September 30, 2019.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel
therapies to improve the lives of patients with chronic liver
disease 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; advancement of these additional clinical programs is
largely dependent on finding a suitable partner. 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 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 the treatment of severe atopic
dermatitis, moderate-to-severe plaque psoriasis and in cancer
immunotherapy and in other therapeutic indications. 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 may
not be successful in scaling up manufacturing and meeting
requirements related to chemistry, manufacturing and control
matters; 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, 2017, 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.
Contact: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, |
|
2018 |
2017 |
2018 |
2017 |
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
1,505 |
|
$ |
3,503 |
|
$ |
5,279 |
|
$ |
10,719 |
|
General
and administrative |
|
1,175 |
|
|
911 |
|
|
5,338 |
|
|
3,155 |
|
Total
operating expenses |
|
2,680 |
|
|
4,414 |
|
|
10,617 |
|
|
13,874 |
|
Total
operating loss |
|
(2,680 |
) |
|
(4,414 |
) |
|
(10,617 |
) |
|
(13,874 |
) |
Other
income: |
|
|
|
|
Interest
and other |
|
(72 |
) |
|
6 |
|
|
(233 |
) |
|
21 |
|
Total
other income |
|
(72 |
) |
|
6 |
|
|
(233 |
) |
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(2,752 |
) |
$ |
(4,408 |
) |
$ |
(10,850 |
) |
$ |
(13,853 |
) |
Preferred stock dividends and accretion costs |
|
(294 |
) |
|
(254 |
) |
|
(848 |
) |
|
(827 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
applicable to common stock |
$ |
(3,046 |
) |
$ |
(4,662 |
) |
$ |
(11,698 |
) |
$ |
(14,680 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
$ |
(0.07 |
) |
$ |
(0.13 |
) |
$ |
(0.30 |
) |
$ |
(0.42 |
) |
Shares used in computing basic and diluted net loss per share |
|
40,921 |
|
|
35,165 |
|
|
38,822 |
|
|
34,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Data
|
|
September 30,
2018 |
|
|
December 31,
2017 |
|
|
|
(in thousands) |
Cash and
cash equivalents |
$ |
10,136 |
|
$ |
3,053 |
|
Total
assets |
|
10,616 |
|
|
4,161 |
|
Total
current liabilities |
|
1,646 |
|
|
2,968 |
|
Total
liabilities |
|
1,646 |
|
|
2,968 |
|
Total
redeemable, convertible preferred stock |
|
1,723 |
|
|
1,723 |
|
Total
stockholders’ equity |
$ |
7,247 |
|
$ |
(530 |
) |
|
|
|
|
|
|
|
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