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 three
months ended September 30, 2022. 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, stated: “The
Company made outstanding progress this quarter. In addition to
securing the largest financing in the Company’s history, which
extended our cash runway for planned trial expenditures through
2024, we accelerated recruitment on NAVIGATE, our global pivotal
NASH cirrhosis trial, and continue to progress towards our goal of
full enrollment around the end of 2022. We
presented at multiple conferences culminating in our submission of
five scientific presentations that were accepted and presented at
the American Association for the Study of Liver Diseases (AASLD) in
the first week of November. During AASLD, we had
the opportunity to host some of our investigators and their staff.
I want to thank all of those who attended for their dedication to
our program and for the insight they shared with us. I truly
believe the knowledge you shared will enable us to reach our
enrollment goals, as well as our overall goals for our study.
“Additionally, as recently announced, our team successfully
completed an Investigational New Drug (IND) application and
received a Study May Proceed letter from FDA, for belapectin in
combination with a Keytruda for the treatment of Head and Neck
cancers.”
Dr. Pol Boudes, Chief Medical Officer, stated: “I, along with
several other team members, have visited multiple sites and
investigators over the past few months, in addition to meeting with
several more at recent industry conferences. We continue to receive
consistent and supportive feedback from investigators regarding the
importance and uniqueness of NAVIGATE and the potential to bring a
therapy to patients with cirrhosis and portal hypertension for this
large unmet medical need. We have now randomized 279 patients of
the planned 315 patients with an additional 74 patients currently
in screening.”
Financial Results
For the three months ended September 30, 2022, the Company
reported a net loss applicable to common stockholders of $8.6
million, or ($0.14) per share, compared to a net loss applicable to
common stockholders of $8.6 million, or ($0.14) per share for the
three months ended September 30, 2021.
Research and development expenses for the three months
ended September 30, 2022, were $6.6 million compared with $6.6
million for the three months ended September 30, 2021. These are
primarily due to costs related to the NAVIGATE clinical trial and
other supportive activities. General and administrative expenses
for the three months ended September 30, 2022 were $1.5
million, compared to $1.6 million for the three months ended
September 30, 2021. The decrease was primarily due to a decrease in
legal expenses.
As of September 30, 2022, the Company had $15.8
million of cash and cash equivalents. The Company believes it
has sufficient cash, including availability under its $60 million
line of credit, to fund currently planned operations and research
and development activities through at least December 31,
2024.
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 (www.NAVIGATEnash.com),
titled “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 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
Company-sponsored Phase 2 development program, which the company is
exploring.
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 9,000 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, 2021, 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
belapectin (GR-MD-02).
Condensed Consolidated Statements of Operations
|
Three Months Ended September
30, |
Nine Months Ended September
30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
Research and development |
$6,598 |
|
$6,613 |
|
$22,730 |
|
$17,962 |
|
General and administrative |
|
1,524 |
|
|
1,631 |
|
|
4,989 |
|
|
4,792 |
|
Total operating expenses |
|
8,122 |
|
|
8,244 |
|
|
27,719 |
|
|
22,754 |
|
Total operating loss |
|
(8,122 |
) |
|
(8,244 |
) |
|
(27,719 |
) |
|
(22,754 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
18 |
|
|
1 |
|
|
22 |
|
|
3 |
|
Interest expense |
|
(269 |
) |
|
(111 |
) |
|
(725 |
) |
|
(217 |
) |
Change in fair value of derivative |
|
(224 |
) |
|
(166 |
) |
|
280 |
|
|
(338 |
) |
Total other income |
|
(475 |
) |
|
(276 |
) |
|
(423 |
) |
|
(552 |
) |
Net loss |
$(8,597 |
) |
$(8,520 |
) |
$(28,142 |
) |
$(23,306 |
) |
Preferred stock dividends |
|
16 |
|
|
(37 |
) |
|
(32 |
) |
|
(104 |
) |
Warrant modification |
|
|
|
|
Net loss applicable to common stock |
$(8,581 |
) |
$(8,557 |
) |
$(28,174 |
) |
$(23,410 |
) |
Basic and diluted net loss per share |
$(0.14 |
) |
$(0.14 |
) |
$(0.47 |
) |
$(0.40 |
) |
Shares used in computing basic and diluted net loss per share |
|
59,396 |
|
|
59,290 |
|
|
59,380 |
|
|
58,253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
(in thousands) |
Cash and cash equivalents …… |
$ |
15,831 |
|
$ |
39,648 |
Total assets……………………...… |
|
17,914 |
|
|
41,827 |
Total current
liabilities…..….. |
|
9,588 |
|
|
9,033 |
Total
liabilities.………………..….. |
|
40,249 |
|
|
39,211 |
Total redeemable, convertible
preferred stock…. |
|
1,723 |
|
|
1,723 |
Total stockholders’ (deficit)
equity ….. |
$ |
(24,058) |
|
$ |
893 |
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