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 quarter
ended March 31, 2021. 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.
Joel Lewis, Chief Executive Officer and President of Galectin
Therapeutics, said, “The start to the new year has been an exciting
and productive time for Galectin Therapeutics in both our NAVIGATE
Phase 2b/3 clinical trial in NASH cirrhosis as well as the cancer,
combination immunotherapy trial being conducted in collaboration
with the Providence Cancer Institute in Portland, Oregon. In
addition, since the beginning of the year, we have raised fresh
capital and brought on Dr. Ben Carson, Sr., a world-renowned
physician and former Secretary of Housing and Urban Development, as
a special consultant. We very much look forward to working with Dr.
Carson.
“In support of our innovative NAVIGATE study,” continued Lewis,
“we launched NAVIGATEnash.com, a new information resource about
NASH cirrhosis for both patients and physicians. NASH cirrhosis is
still largely overlooked and remains a major unmet medical need.
I’ve been deeply moved by the determination of this community of
NASH cirrhosis patients and the physicians who treat them.
“In our cancer, combination immunotherapy trial, results of the
Phase 1 trial were published in the highest ranked fully open
access peer-reviewed immunology journal. The study suggests
combination therapy with belapectin results in a better objective
response rate with fewer adverse events than pembrolizumab
(KEYTRUDA®) alone. Brendan Curti, M.D., the first author of the
paper, noted galectin-3 is an important driver of tumor-induced
immunosuppression. This clinical study constitutes proof-of-concept
that the addition of our galectin-3 inhibitor, belapectin, to a
PD-1 inhibitor can benefit cancer patients.
“Of course,” concluded Lewis, “I would be remiss if I did not
thank our Chairman, Mr. Richard Uihlein, who continues to
demonstrate his strong support and provided additional funding to
help advance our NAVIGATE trial, and for which we are deeply
grateful.”
Richard E. Uihlein, Chairman of the Board, added, “This quarter
has been an important one for Galectin Therapeutics, and having Dr.
Ben Carson on our team is an investment in the future. The progress
being made in both our NASH cirrhosis study and our collaboration
on cancer immunotherapy demonstrates the important science behind
what we are doing. Galectin-3 is involved in a wide range of human
diseases, and my recent investment in the company underscores my
commitment to develop belapectin to its full potential.”
Dr. Ben Carson, Sr., Engaged as Special
Consultant
- Engaged Ben Carson, Sr., M.D., 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. In particular, Dr. Carson will help increase
awareness of Galectin Therapeutics including our ongoing Phase 2b/3
NAVIGATE clinical trial in NASH cirrhosis, our 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.
Recent Financings
- Raised $10 million in a convertible debt financing with Richard
E. Uihlein, the Company’s Chairman and largest individual
stockholder. The debt 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.
NAVIGATE Trial Update
- Launched NAVIGATEnash.com, a trial website dedicated to
educating patients and physicians about liver cirrhosis resulting
from non-alcoholic steatohepatitis (NASH) as well as support
NAVIGATE, the Company’s innovative, seamless adaptive Phase 2b/3
study in NASH cirrhosis.
- Galectin Therapeutics continues to actively recruit patients
into NAVIGATE, its seamless, adaptive Phase 2b/3 study of
belapectin for the prevention of esophageal varices in NASH
cirrhosis.
Peer-reviewed publications, Scientific Presentations and
Conferences
- Published in the Journal for ImmunoTherapy of Cancer
(JITC), the highest ranked fully open access immunology
journal, a peer-reviewed paper entitled, “Enhancing Clinical
and Immunological Effects of anti-PD-1 with Belapectin, a
Galectin-3 Inhibitor” (doi:10.1136/jitc-2021-002371), provided
further clinical evidence that using belapectin, a potent
galectin-3 inhibitor, in combination with pembrolizumab
(KEYTRUDA®), a PD-1 inhibitor, significantly enhances tumor
response to immunotherapy in patients with advanced metastatic
melanoma (MM) and head and neck squamous cell carcinoma (HNSCC).
The paper describes results from an ongoing Phase 1 clinical study,
a collaboration between Galectin Therapeutics and Providence Cancer
Institute in Portland, Oregon. An objective response was observed
in 50% of MM (7/14) and 33% of HNSCC (2/6) patients. This compares
favorably to published response rates on pembrolizumab alone.
- At the 4th Global NASH Congress, which took place
virtually on April 29, 2021, Pol F. Boudes, M.D., Chief
Medical Officer, reviewed Galectin Therapeutics’ scientific and
clinical activities in NASH cirrhosis in a presentation entitled,
“An innovative clinical development program: belapectin for NASH
cirrhosis.”
Financial Results
For the three months ended March 31, 2021, the Company
reported a net loss applicable to common stockholders of $6.3
million, or ($0.11) per share, compared to a net loss applicable to
common stockholders of $3.6 million, or ($0.06) per share for the
three months ended March 31, 2020. The increase is largely due an
increase in 2021 research and development expenses related to the
Company’s NAVIGATE trial.
Research and development expense for the three months
ended March 31, 2021, was $4.9 million compared with $2.1
million for the three months ended March 31, 2020. The increase was
primarily due to costs related to our NAVIGATE clinical trial and
other supportive activities. General and administrative expenses
for the three months ended March 31, 2021, were $1.4 million,
compared to $1.4 million for the three months ended March 31,
2020.
As of March 31, 2021, the Company had $20.8
million of cash and cash equivalents. On April 16, 2021, the
Company received $10,000,000 in proceeds from an unsecured
convertible promissory note from its Board Chairman, Richard E.
Uihlein. 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 September
30, 2022.
The Company expects that it will require more cash to fund
operations after September 30, 2022 and believes it will be able to
obtain additional financing as needed. Currently, we expect to
require an additional approximately $35-$40 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. 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 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 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
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
|
Three Months Ended March 31, |
|
|
2021 |
|
|
2020 |
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
4,899 |
|
$ |
2,144 |
|
General and administrative |
|
1,418 |
|
|
1,440 |
|
Total operating expenses |
|
6,317 |
|
|
3,584 |
|
Total operating loss |
|
(6,317 |
) |
|
(3,584 |
) |
Other income (expense): |
|
|
Interest income |
|
1 |
|
|
50 |
|
Interest expense |
|
(22 |
) |
|
(22 |
) |
Total other income |
|
(21 |
) |
|
28 |
|
|
|
|
|
|
|
|
Net loss |
$ |
(6,338 |
) |
$ |
(3,556 |
) |
Preferred stock dividends |
|
2 |
|
|
6 |
|
|
|
|
|
|
|
|
Net loss applicable to common stock |
$ |
(6,340 |
) |
$ |
(3,550 |
) |
Basic and diluted net loss per share |
$ |
(0.11 |
) |
$ |
(0.06 |
) |
Shares used in computing basic and diluted net loss per share |
|
57,132 |
|
|
56,956 |
|
Condensed Consolidated Balance Sheet Data
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
27,760 |
$ |
27,142 |
Total assets |
|
22,897 |
|
29,600 |
Total current liabilities |
|
4,663 |
|
5,399 |
Total liabilities |
|
4,663 |
|
5,407 |
Total redeemable, convertible
preferred stock |
|
1,723 |
|
1,723 |
Total stockholders’
equity |
$ |
16,511 |
$ |
22,470 |
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