Galectin Therapeutics Announces Closing of $10 Million in Debt Financing from Its Chairman, Richard E. Uihlein
December 21 2021 - 8:00AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today announced that it
has closed on the second $10 million convertible note pursuant to a
financing agreement entered in September, 2021, with Richard E.
Uihlein, the Company’s Chairman and largest individual stockholder.
In total, the Company has received $30 million in three convertible
notes from Mr. Uihlein in 2021.
The convertible notes are unsecured and bear 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 each loan closing. The conversion price of the debt and
interest is fixed at 228% above the price per share of common stock
on the day prior to each closing or $5.00 per share, whichever is
greater.
Richard E. Uihlein, Chairman of Galectin Therapeutics,
commented, “As I have stated many times, I remain deeply committed
to the Company’s success and our goal of addressing large, unmet
medical needs. I am proud of our progress in 2021 and look forward
to achievement of additional significant milestones in 2022 and
beyond. I have confidence in our team and our science, and I look
forward to furthering our programs.”
“I thank Mr. Uihlein for his remarkable commitment to the
Company. As I have said previously, the impact of his financial
backing and leadership as Chairman cannot be overstated,” said Joel
Lewis, president and Chief Executive Officer of Galectin
Therapeutics. “We expect to continue making significant progress in
our NAVIGATE trial for patients with NASH cirrhosis, and we also
are exploring how to best move forward in the treatment of advanced
head and neck cancer, where we have seen promising early results of
belapectin in combination with KEYTRUDA. Earlier this month,
following our Annual Stockholders Meeting, I outlined our
achievements in 2021 and our goals for 2022, which you may review
at https://investor.galectintherapeutics.com/node/16661/html. We
look forward to reporting our progress in 2022.”
About Belapectin
Belapectin 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 randomization of patients in August, 2020,
and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3
has a significant role in cancer, and the Company has supported a
Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA
in advanced melanoma and in head and neck cancer. This trial
provided a strong rationale for moving forward into a Phase 2
development program which the company is considering.
About Fatty Liver Disease with Advanced Fibrosis and
Cirrhosis
Non-alcoholic steatohepatitis (NASH) has become a common disease
of the liver with the rise in obesity and other metabolic diseases.
NASH is estimated to affect up to 28 million people in the U.S. It
is characterized by the presence of excess fat in the liver along
with inflammation and hepatocyte damage (ballooning) in people who
consume little or no alcohol. Over time, patients with NASH can
develop excessive fibrosis, or scarring of the liver, and
ultimately liver cirrhosis. It is estimated that as many as 1 to 2
million individuals in the U.S. will develop cirrhosis as a result
of NASH, for which liver transplantation is the only curative
treatment available. Approximately 8,890 liver transplants are
performed annually in the U.S. There are no drug therapies approved
for the treatment of liver fibrosis or cirrhosis.
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. 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
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
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.
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