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, 2022. 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: “As previously reported, we completed
recruitment in late December 2022 and randomization by the end of
February 2023 in our adaptively designed Phase 2b/3 NAVIGATE trial
for the prevention of esophageal varices in patients with NASH
cirrhosis with a total of 357 patients. We randomized more patients
than we had anticipated, potentially adding power to the study.
From the beginning of December until the end of February, we
randomized more than 5 patients per week, notwithstanding the
holiday season. Typically, clinical trials become more efficient as
time elapses over the screening window.
“We look forward to managing this trial and obtaining interim
analysis results from the Phase 2b portion in the fourth quarter of
2024. The Company’s results will be the first, and as of now, the
only late-stage trial in compensated cirrhosis that has advanced to
include portal hypertension caused by NASH. This patient population
has no current therapeutic option, other than a liver
transplantation.
“Additionally, we are furthering our efforts by continuing to
evaluate options and develop plans for a potential Phase 2 clinical
trial of belapectin in combination with Keytruda in patients with
advanced head and neck cancers. Our team is fully committed to
maximize the value of our company for the stockholders by advancing
our programs for patients.”
Dr. Pol Boudes, Chief Medical Officer, stated: “Compared to NASH
pre-cirrhotic stages, cirrhosis of the liver is characterized by a
distinct pathophysiology, with activated macrophages, the target of
belapectin, playing a central role in the progression to portal
hypertension and, ultimately, liver failure. As recently announced,
the third Data Safety Monitoring Board (“DSMB”) evaluation of
NAVIGATE was positive, and the study can continue as planned. This
is a significant milestone for us because with 357 patients
randomized we now have a large database of patient exposure to
belapectin, and some of these patients have received more than a
year and a half of treatment. The safety and tolerance of candidate
drugs can be a significant problem for cirrhotic patients who are
compromised by their liver disease and may have difficulty
metabolizing drugs. We are very encouraged by the developing safety
profile of belapectin, and we to continue to be optimistic that the
results of NAVIGATE can one day bring a therapy to patients with
NASH cirrhosis that currently can only contemplate a liver
transplantation as a therapeutic option.”
Financial Results
For the year ended December 31, 2022, the Company reported
a net loss applicable to common stockholders of $38.9 million, or
($0.65) per share, compared to a net loss applicable to common
stockholders of $30.7 million, or ($0.52) per share for the year
ended December 31, 2021. The increase is largely due to an increase
in 2022 research and development expenses related to the Company’s
NAVIGATE trial.
Research and development expenses for the year
ended December 31, 2022, were $31.7 million compared with
$23.8 million for the year ended December 31, 2021. The increase
was primarily due to costs related to our NAVIGATE clinical trial
and other supportive activities, including hiring additional
employees. General and administrative expenses for the year
ended December 31, 2022, were $6.6 million, compared to $6.4
million for the year ended December 31, 2021. The increase was
primarily due to non-cash stock-based compensation expense
partially offset by decreases in legal and insurance expenses.
As of December 31, 2022, the Company had $18.6
million of cash and cash equivalents. Additionally, the
Company has $50 million remaining available under a $60 million
line of credit provided by its chairman to fund operations. The
Company believes it has sufficient cash to fund currently planned
operations and research and development activities through at
least December 31, 2024.
The Company expects that it will require more cash to fund
operations after December 31, 2024 and believes it will be able to
obtain additional financing as needed. 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
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,” completed randomization of
357 patients in February 2023 with top-line data expected from the
Phase 2b portion in the fourth quarter of 2024, 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), also known as fatty liver
disease, 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, 2022, 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
|
Year EndedDecember 31, |
|
2022 |
|
2021 |
|
|
|
Operating expenses: |
|
|
Research and development |
$ |
31,737 |
|
|
$ |
23,818 |
|
General and administrative |
|
6,615 |
|
|
|
6,361 |
|
Total operating expenses |
|
38,352 |
|
|
|
30,179 |
|
Total operating loss |
|
(38,352 |
) |
|
|
(30,179 |
) |
Other income (expense): |
|
|
Interest income |
|
52 |
|
|
|
3 |
|
Interest expense |
|
(1,033 |
) |
|
|
(489 |
) |
Change in fair value of derivatives |
|
557 |
|
|
|
138 |
|
Total other income |
|
(424 |
) |
|
|
(348 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(38,776 |
) |
|
$ |
(30,527 |
) |
Preferred stock dividends |
|
(97 |
) |
|
|
(171 |
) |
|
|
|
|
|
|
|
|
Net loss applicable to common stock |
$ |
(38,873 |
) |
|
$ |
(30,698 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.65 |
) |
|
$ |
(0.52 |
) |
Shares used in computing basic and diluted net loss per share |
|
59,391 |
|
|
|
58,527 |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data
|
|
December 31, 2022 |
|
|
December 31, 2021 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
18,592 |
|
|
$ |
39,648 |
|
Total assets |
|
21,285 |
|
|
|
41,827 |
|
Total current liabilities |
|
13,012 |
|
|
|
9,033 |
|
Total liabilities |
|
53,479 |
|
|
|
39,211 |
|
Total redeemable, convertible
preferred stock |
|
1,723 |
|
|
|
1,723 |
|
Total stockholders’ equity
(deficit) |
$ |
(33,917 |
) |
|
$ |
893 |
|
|
|
|
|
|
|
|
|
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