Planning for Phase 3 clinical trial (NASH-RX)
nearing completion for GR-MD-02, the first drug to show positive
results in a clinical trial in patients with compensated NASH
cirrhosis
Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for the year ended December 31, 2018. 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.
Harold H. Shlevin, Ph.D., President and Chief
Executive Officer of Galectin Therapeutics, said, “Over the
last year we have been positioning the company to undertake a Phase
3 clinical trial -- the NASH-RX trial -- with our proprietary
compound GR-MD-02, the first drug to show positive results in a
clinical trial in patients with compensated NASH cirrhosis without
esophageal varices. Our trial will be noteworthy because it is
investigating NASH cirrhosis, a condition that is more closely
linked to liver failure and its life-threatening implications than
earlier stages of NASH, which are the focus of the majority of NASH
drugs in development. Leading NASH experts have been engaged
throughout the process to provide advice and counsel to strengthen
our plan for the NASH-RX Phase 3 clinical trial.
“Since presenting the results of the NASH-CX
trial, the Company has had ongoing discussions with U.S. Food and
Drug Administration (FDA), including a Type C Meeting with the
Agency on February 6, 2019. At that meeting we discussed our
proposal to use progression to varices as the primary surrogate
endpoint in the NASH-RX trial. In this meeting, the FDA confirmed
it is supportive of the use of progression to varices as a
potential surrogate endpoint and progression to large varices as a
component of a composite clinical benefit endpoint, pending
additional requested information. Galectin will address and
implement additional FDA requests and considerations for the Phase
3 trial, when and where possible. Given the newness of the
endpoint and the new information to be generated in the trial, some
information requests may not be able to be addressed fully until
data from the NASH-RX Phase 3 trial is available. We are very
pleased with the progress achieved thus far and anticipate that the
plan that is now in the process of finalization will provide
meaningful clinical outcomes.
“Beyond our NASH trial, we will continue to pursue
other paths forward for GR-MD-02, such as the significant market
for evolving new combination cancer therapies. Illustrative
of these opportunities, investigators plan to expand a combination
immunotherapy trial involving GR-MD-02 and KEYTRUDA as a result of
the favorable Objective Response Rate (ORR) reported in the first 3
cohorts. “Throughout fiscal 2018, we also continued to strengthen
our global intellectual property portfolio with a number of new
patents awarded and/or submitted. As the understanding of
GR-MD-02 improves, it is becoming increasingly clear that
galectins, and specifically galectin-3, play an important role in a
number of critical pathologies, contributing value to our patent
portfolio.
“Finally, we believe that our capital structure is
substantially improved as a result of the recent conversion of the
preferred stock by 10X Fund L.P. into common stock.”
Richard E. Uihlein, Chairman of the Board, added,
“The work on our NASH-RX Phase 3 plan remains paramount.
There is a clear need for a treatment for what the medical
community has identified as an unmet need in the rising incidence
of NASH around the world. Given the biological response
GR-MD-02 has elicited in both the laboratory and in human trials, a
well-planned NASH-RX Phase 3 trial informed by some of the top
researchers on NASH can help ensure that hope is provided for the
many cirrhotic patients who may benefit from the therapy once
approved and for which there are no therapeutic options.”
Summary of Key Development Programs and
Updates
- Continued to develop plans for its NASH-RX Phase 3 clinical
trial program with the 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 NASH-RX
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.
- Received a three-year extension on the $10 million unsecured
line of credit entered into on December 19, 2017, for both
borrowings and maturity. The line of credit arrangement with
Richard E. Uihlein, Chairman of the Board of Directors and a
shareholder, originally provided for borrowings to occur through
December 31, 2018, with all principal and any interest maturing and
coming due on December 31, 2019. There were two amendments
that extended borrowings through December 31, 2021, and
maturity of principal and interest to December 31, 2022. To date,
the Company has not made any borrowings under this line of
credit.
- Announced that its largest institutional shareholder, 10X Fund
L.P., has converted all of its Series B Convertible Preferred Stock
into Common Stock of Galectin Therapeutics. All special voting
rights and protective provisions that previously benefited the
Series B Preferred Stock were extinguished by the conversion to
Common Stock.
Scientific Presentations and
Conferences
- Dr. Harold H. Shlevin presented at the 2nd Annual Anti-Fibrotic
Drug Development Summit (AFDD) on November 29. In his presentation,
titled “Physiological Control Systems Involving Galectins in the
Treatment of Diseases,” Dr. Shlevin discussed the following: The
significant involvement of galectins in various biological
functions and pathologies and how this has driven recent interest
in therapeutic discovery and development for clinical intervention
against fibrosis, cancer, and other disorders; and the role of
galectins in mediating physiological control processes, including
an understanding of structure-function relationships, the
mechanisms of action at the molecular level, and the evolving
clinical data on their role in the treatment of various
diseases.
- Dr. Harold H. Shlevin will be presenting at the H.C. Wainwright
Global Life Sciences Conference being held in London April 7 – 9,
2019.
Dr. Shlevin concluded, “Galectin Therapeutics
continues to advance GR-MD-02 as a potential therapy for NASH
cirrhosis where elevated levels of galectin protein and
inflammation play key roles in the pathophysiology of the
diseases. This past year has been a period of steady
progress, culminating in the collaboration of a number of leading
clinicians in the formulation of our NASH-RX Phase 3 trial plan in
selected NASH cirrhosis patients and the recent meeting with the
FDA. We believe this methodical approach to Phase 3 planning is the
best path to build value in our galectin franchise in NASH and,
secondarily, to maximize potential of this platform technology to
treat other diseases.” Financial Results
For the year ended December 31, 2018, the
Company reported a net loss applicable to common stockholders of
$15.0 million, or $0.38 per share, compared to a net loss
applicable to common stockholders of $17.5 million, or $0.49 per
share, for the full year 2017. The decrease is largely due to lower
preclinical and clinical costs somewhat offset by higher business
development and non-cash stock-based compensation expenses.
Research and development expense for 2018 was $6.5 million compared
with $11.7 million for 2017. The decrease primarily relates to a
reduction in costs for the NASH-CX Phase 2 clinical trial as it
wound down, and lower preclinical costs. General and
administrative expense for 2018 were $7.1 million, compared to $4.5
million for the full year 2017, primarily due to an increase in
business development and non-cash stock-based compensation
expenses. As of December 31, 2018, the Company had $8.3
million of cash and cash equivalents. In December 2017, the
Company entered into a $10 million unsecured line of credit and
received $4.5 million in proceeds in January 2018 from common stock
warrant exercises. There have not been, and currently are no,
borrowings under the line of credit. The Company believes it
has sufficient cash, including availability under the line of
credit, to fund currently planned operations and research and
development activities through at least March 31, 2020.
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, 2018, 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
|
|
|
Year
EndedDecember 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
(in thousands, exceptper share data) |
|
Operating expenses: |
|
|
|
Research and development |
$ |
6,471 |
|
$ |
11,721 |
|
General and administrative |
|
7,131 |
|
|
4,526 |
|
Total operating expenses |
|
13,602 |
|
|
16,247 |
|
Total operating loss |
|
(13,602) |
|
|
(16,247) |
|
Other
income: |
|
|
Interest and other |
|
(298) |
|
|
12 |
|
Total other income |
|
(298) |
|
|
12 |
|
Net
loss |
$ |
(13,900) |
|
$ |
(16,235) |
|
Preferred stock dividends |
|
(1,147) |
|
|
(1,232) |
|
Net loss applicable to common stock |
$ |
(15,047) |
|
$ |
(17,467) |
|
Basic
and diluted net loss per share |
$ |
(0.38) |
|
$ |
(0.49) |
|
Shares
used in computing basic and diluted net loss per share |
|
39,414 |
|
|
35,521 |
|
|
Condensed Consolidated Balance Sheet
Data
|
|
|
December 31,2018 |
|
December 31, 2017 |
|
|
(in thousands) |
Cash and cash
equivalents |
$ |
8,253 |
$ |
3,053 |
|
Total
assets |
|
9,006 |
|
4,161 |
|
Total
current liabilities |
|
2,108 |
|
2,968 |
|
Total
liabilities |
|
2,108 |
|
2,968 |
|
Total
redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
|
Total
stockholders’ equity |
$ |
5,175 |
$ |
(530) |
|
|
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