Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results and provided a business update for the year ended
December 31, 2020. 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.
Joel Lewis, Chief Executive Officer and President
of Galectin Therapeutics, said, “I am very encouraged by the
progress achieved in fiscal 2020, and remain extremely optimistic
for 2021. Given the current challenging environment, I am proud of
our success, highlighted by site activations and ongoing enrollment
of our innovative NAVIGATE study. This global program continues to
be the only active late-stage trial of patients with compensated
NASH cirrhosis, where the medical need is greatest and with a
clinically meaningful endpoint. Our concurrent hepatic impairment
study will also provide important information on belapectin
tolerance, safety and exposure in advanced cirrhotic patients.
Over the course of the last year at the Board’s
direction we have taken aggressive steps to strengthen our
organization, adding Pol Boudes as Chief Medical Officer, as well
as Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of
Directors. These changes informed my decision to accept the role of
Chief Executive Officer, and they afforded me the confidence to
receive 80% of my compensation in the form of Galectin stock.
Additionally, I believe this breadth of talent reinvigorated
Galectin and placed the Company in a position to monetize our
assets. This has served to strengthen my commitment to my
compensation strategy, which aligns my interests with all
shareholders.
More recently, the peer-reviewed publication of a
well-recognized mouse model has shown that the combination of
belapectin, a galectin-3 inhibitor, with immunotherapy reprograms
the tumor microenvironment. This favors anti-tumor immunity,
results in better anti-tumor activity, and most importantly, brings
further rationale for our ongoing cancer trial combining belapectin
with Keytruda®, a potent PD-1 inhibitor. Providence Cancer
Institute is currently conducting the study and preliminary results
suggest improved activity and, potentially, improved tolerance of
this regimen.
I am extremely confident in our science, our team,
and our progress,” concluded Lewis. The upcoming year will be
dedicated to advancing our trial in NASH cirrhosis and supporting
investigations of belapectin’s safety and efficacy in other
indications, such as the ongoing cancer trial in conjunction with
the Providence Cancer Institute. I also want to recognize the
outstanding efforts of our entire team, who persevered through the
challenges precipitated by COVID-19 in the interest of developing a
therapy for NASH cirrhosis, a critical, unmet medical need. Let me
once again thank the investigators and patients participating in
our NAVIGATE trial, where a positive outcome would be very
clinically relevant for patients with NASH cirrhosis.”
Richard E. Uihlein, Chairman of the Board, added,
“I want to echo Joel’s sentiment and thank Pol, Jack and our entire
team for their dedication throughout this past year, especially
their commitment to initiating our exciting NAVIGATE trial under
less than optimal circumstances due to the global pandemic. Joel
has proven to be the leader we all expected, and I am pleased with
the progress he has achieved since assuming the role and confident
in his ability to unlock the value of our proprietary compound,
belapectin. Peer-reviewed research, such as that recently published
in OncoImmunology, clearly confirms our basic scientific premise
regarding belapectin’s anti-inflammatory characteristics in a broad
range of fibrosis as well as its ability to potentially enhance the
efficacy of cancer therapies. As such, the NAVIGATE trial
represents an opportunity to further demonstrate the
anti-inflammatory activity of belapectin, which would open up vast
new opportunities to investigate other indications and establish
our compound as a foundation for a platform technology.”
NAVIGATE Trial Update
- The NAVIGATE trial uses a seamless,
adaptive design to confirm dose selection and reaffirm the observed
efficacy of belapectin to prevent the development of esophageal
varices in the NASH-CX trial. Pre-planned adaptations will inform
the larger Phase 3 trial component.
- Key clinical study milestones:
- First patient randomized August
2020
- 130+ sites, 12 countries in North
America, Europe, Asia and Australia
- Phase 2b part to Interim Analysis will
be ~315 patients
- Recruiting period for phase 2b portion
now expected to conclude around the end of 2021 due to COVID-19
impact on recruitment
- Key inclusion criteria - NASH
cirrhosis (baseline or historical liver biopsy), clinical sign of
portal hypertension, no esophageal varices (esophago-gastro
endoscopy)
- Interim analysis expected late
2023
Peer-reviewed publication, Scientific
Presentations and Conferences
- OncoImmunology published a
peer-reviewed article describing how belapectin, a potent
galectin-3 inhibitor, in combination with an anti-OX40 (CD134)
monoclonal antibody, reduces tumor progression compared to either
agent alone. The paper, titled “Galectin-3 inhibition with
belapectin combined with anti-OX40 therapy reprograms the tumor
microenvironment to favor anti-tumor immunity,” describes results
from a collaboration between Galectin Therapeutics and Providence
Cancer Institute highlighting the mechanism of action of the
combination which is explained by a reduction in myeloid-derived
suppressor cell infiltration and function coupled to an increase in
T-cell effector function. For many years, galectin-3 has been known
to play a key role in the control of tumor-induced
immunosuppression. Galectin-3 acts to maintain tumor growth, in
part, by supporting the generation of suppressive macrophages and
inhibiting T cell function. This creates an attractive rationale
for the use of a galectin-3 inhibitor, such as belapectin, to
improve anti-tumor activities of multiple cancer therapies.
Financial Results
For the year ended December 31, 2020, the Company
reported a net loss applicable to common stockholders of $23.6
million, or ($0.41) per share, compared to a net loss applicable to
common stockholders of $20.2 million, or ($0.39) per share for the
full year 2019. The increase is largely due to an increase in
research and development expenses related to our NAVIGATE clinical
trial, partially offset by a non-cash, one-time warrant
modification charge of $6.6 million in 2019.Research and
development expense for 2020 was $18.0 million compared with $7.5
million for 2019. The increase was primarily due to costs related
to our NAVIGATE clinical trial, along with preparations and some
preclinical activities incurred in support of the clinical program,
such as development and reproductive toxicity studies, clinical
supplies and other supportive activities. General and
administrative expenses for 2020 were $5.5 million, down from $6.0
million for the full year 2019, primarily due to decreases in
legal, investor relations and non-cash stock-based compensation
expenses partially offset by an increase in insurance expenses.As
of December 31, 2020, the Company had $27.1 million of
cash and cash equivalents. The Company also has a $10 million
unsecured line of credit, under which no borrowings have been made
to date. 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, 2022.The Company expects that it will require more cash
to fund operations after March 31, 2022, and believes it will be
able to obtain additional financing as needed. The currently
planned operations include costs related to our adaptively designed
NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require
an additional approximately $45-$50 million to cover costs of the
trial to reach the planned interim analysis estimated to occur in
the second half of 2023 along with drug manufacturing and other
scientific support activities and general and administrative costs
and further amounts to complete the Phase 3 portion of the trial.
However, there can be no assurance that we will be successful in
obtaining such new financing or, if available, that such financing
will be on terms favorable to us.
About Galectin
TherapeuticsGalectin Therapeutics is dedicated to
developing novel therapies to improve the lives of patients with
chronic liver disease and cancer. Galectin’s lead drug belapectin
(formerly known as 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, for which
it has Fast Track designation by the U.S. Food and Drug
Administration. 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 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 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
belapectin 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 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 trial
endpoints required by the FDA may not be achieved; Galectin may not
be successful in developing effective treatments and/or obtaining
the requisite approvals for the use of belapectin 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
currently planned clinical trial and any future clinical studies as
modified to meet the requirements of the FDA may not produce
positive results in a timely fashion, if at all, and could require
larger and longer trials, which would be 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. Global factors such as coronavirus may continue to
impact NASH patient populations around the globe and slow trial
enrollment and prolong the duration of the trial and significantly
impact associated costs. 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, 2020, 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.
Company 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. Belapectin is
the USAN assigned name for Galectin Therapeutics’ galectin-3
inhibitor GR-MD-02.
Condensed Consolidated Statements of
Operations
|
Year Ended December 31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
Operating expenses: |
|
|
Research and
development |
$ |
17,976 |
|
$ |
7,467 |
|
General and
administrative |
|
5,468 |
|
|
5,971 |
|
Total operating expenses |
|
23,444 |
|
|
13,438 |
|
Total operating
loss |
|
(23,444 |
) |
|
(13,438 |
) |
Other income (expense): |
|
|
Interest
income |
|
66 |
|
|
231 |
|
Interest
expense |
|
(87 |
) |
|
(87 |
) |
Total other income
|
|
(21 |
) |
|
144 |
|
|
|
|
|
|
|
|
Net loss |
$ |
(23,465 |
) |
$ |
(13,294 |
) |
Preferred stock
dividends |
|
(137 |
) |
|
(263 |
) |
Warrant modification |
|
- |
|
|
(6,622 |
) |
|
|
|
|
|
|
|
Net loss applicable to common
stock |
$ |
(23,602 |
) |
$ |
(20,179 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
$ |
(0.41 |
) |
$ |
(0.39 |
) |
Shares used in computing basic and diluted net loss per
share |
|
57,029 |
|
|
52,238 |
|
Condensed Consolidated Balance Sheet
Data
|
|
December 31, 2020 |
|
December 31, 2019 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
27,142 |
$ |
47,480 |
Total assets |
|
29,600 |
|
48,467 |
Total current liabilities |
|
5,399 |
|
2,820 |
Total liabilities |
|
5,407 |
|
2,872 |
Total redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
Total stockholders’ equity |
$ |
29,600 |
$ |
43,872 |
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