World-Renowned Neurosurgeon Dr. Ben Carson, Sr. Joins Galectin Therapeutics as Special Consultant to Accelerate and Enhance D...
April 19 2021 - 8:00AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today announced it has
engaged Dr. Ben Carson, Sr., a world-renowned neurosurgeon and the
17th Secretary of the U.S. Department of Housing and Urban
Development, as a special consultant to assist with development of
the Company’s galectin-3 inhibitor, belapectin, as a treatment for
NASH cirrhosis and in combination with immunotherapy for the
treatment of cancers.
The Company engaged
Dr. Carson to increase awareness of Galectin Therapeutics including
its ongoing Phase 2b/3 NAVIGATE clinical trial in NASH cirrhosis,
its continuing research in combination with cancer immunotherapy,
and its potential in addressing other fibrotic diseases. Dr. Carson
will also assist in the formation of a scientific advisory
committee for the Company, recruit potential members of the
committee, and identify potential strategic commercial and/or
academic partners for the Company.
The Company also
announced that it has entered into a $10 million convertible debt
financing with Richard E. Uihlein, the Company’s Chairman and
largest individual stockholder. The $10 million convertible debt
financing is unsecured and bears interest at a rate of 2%
compounded annually. Additional interest of 2.5% per quarter will
accrue but will only be paid if the debt and interest are converted
into shares of the Company’s common stock, at Mr. Uihlein’s option,
on or prior to maturity, which is four years from the date of the
loan. The conversion price of the debt and interest is fixed at
$5.00 per share of common stock.
“We are proud to
announce our engagement with Dr. Carson, whose scientific and
medical knowledge will be invaluable to the Company as we move
forward with our current trials in NASH cirrhosis and cancer
immunotherapy,” said Joel Lewis, president and Chief Executive
Officer of Galectin Therapeutics. “Additionally, we are grateful
for the continued leadership and support of Mr. Uihlein. We
continue to make progress in our NAVIGATE trial for patients with
NASH cirrhosis, and this financing will support those efforts.”
Dr. Carson stated,
“Galectin Therapeutics and its drug candidate, belapectin, are at
the forefront of research into galectin inhibition, which appears
to be implicated in many diseases, including NASH cirrhosis, which
is a large unmet medical need. More broadly, early results and
potential for belapectin’s use in combination with immunotherapy in
cancer suggests belapectin could address a multitude of indications
where galectin-3 is involved. This has motivated me to apply my
scientific and business skills developed over my long medical
career to help steer the Company forward in navigating its clinical
trials and identifying partnerships.”
Richard E. Uihlein,
Chairman of Galectin Therapeutics, commented on his $10 million
investment, “This financing clearly illustrates that I remain
deeply committed to the Company’s success and its goal of
addressing large, unmet medical needs. On behalf of the Board of
Directors, we are honored to welcome Dr. Carson to the Galectin
Therapeutics team and look forward to working with him to enhance
and accelerate our progress.”
About
Belapectin (GR-MD-02)
Belapectin (GR-MD-02)
is a complex carbohydrate drug that targets galectin-3, a critical
protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays
a major role in diseases that involve scarring of organs including
fibrotic disorders of the liver, lung, kidney, heart and vascular
system. Belapectin binds to galectin-3 and disrupts its function.
Preclinical data in animals have shown that belapectin has robust
treatment effects in reversing liver fibrosis and cirrhosis. A
Phase 2 study showed belapectin may prevent the development of
esophageal varices in NASH cirrhosis, and these results provide the
basis for the conduct of the NAVIGATE trial. The NAVIGATE trial
(NAVIGATEnash.com), entitled “A Seamless Adaptive Phase 2b/3,
Double-Blind, Randomized, Placebo-controlled Multicenter,
International Study Evaluating the Efficacy and Safety of
Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in
NASH Cirrhosis” began enrolling patients in June 2020 and is posted
on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a
significant role in cancer, and the Company is supporting a Phase 1
study in combined immunotherapy of belapectin and KEYTRUDA® in
treatment of advanced melanoma and in head and neck cancer.
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 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. 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 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 current NAVIGATE 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 COVID-19 may limit access to
NASH patient populations around the globe and slow trial enrollment
and prolong the duration of the trial and significantly impact
associated costs as well as impact other trial related activities
including, amongst others, manufacturing and regulatory reviews.
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.
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