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 March 31, 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.
Dr. Pol Boudes, Chief Medical Officer, stated: “As we hear more
about difficulties of reading and interpreting liver biopsies in
pre-cirrhotic NASH, the feedback we get from our investigators
reinforces our belief that using the prevention of esophageal
varices as our primary outcome of efficacy in NAVIGATE is the
appropriate efficacy outcome. Patients that are enrolled in our
program have advanced to the cirrhotic stage of NASH and have
developed portal hypertension, a severe complication of cirrhosis
that impacts their prognosis. This also means that many of our
patients have low platelet counts, and because this increases the
risk of bleeding, it makes a liver biopsy far too dangerous.
These are some of the reasons why we do not believe that biopsies
are appropriate for patient selection or endpoints in our target
population and is also why we even removed the requirement for
baseline biopsies in our NAVIGATE trial. Preventing the
development of an esophageal varix, on the other hand, is a very
relevant and pragmatic clinical outcome. Unfortunately, too many
cirrhotic patients bleed from these varices, and this can be a
life-threatening event. Preventing the development of varices
eliminates this potentially significant adverse outcome related to
cirrhosis. We believe the design of the NAVIGATE study is truly
innovative and allows us to move clinical research for liver
cirrhosis forward.”
Joel Lewis, Chief Executive Officer and President, said: “I am
proud of our team and their accomplishments this quarter. Most
importantly, as a Company, we achieved an extremely significant
milestone. Our previous phase 2 trial, NASH-RX, indicated a
favorable safety profile for belapectin over one year of treatment.
As of today, due to the length of our adaptively designed phase
2b/3 NAVIGATE trial, our safety profile has been further evaluated
by an independent data safety monitoring board who recommended the
trial continue as designed. Additionally, our
innovative trial design allows trial participants to move directly
into the phase 3 treatment course for an additional 18 months. As
these and additional patients continue receiving treatment, we
continue to expand our data on the safety profile of belapectin.
The significance of this safety profile in a severely compromised
patient population cannot be overstated.
“We continued to make progress towards our primary goal of
completing enrollment in our adaptively designed Phase 2b/3
NAVIGATE trial for the prevention of esophageal varices in patients
with NASH cirrhosis. Our strategy to further expand our trial sites
in Mexico and Latin America is well underway. We recently conducted
a very productive in-person investigator meeting in Mexico where we
have added more than 10 new sites. I attended the meeting with my
clinical operations staff, and we are extremely enthusiastic about
the ability of these sites to quickly enroll patients. I am
grateful to all of our investigators and their teams, as well as
our consultants in Mexico, for their time and dedication to our
trial. Enrollment in the United States continued steadily; however,
enrollment in Europe still lags far behind our expectations. We
currently expect enrollment to conclude for the Phase 2b portion
around the end of the third quarter of this year.”
Mr. Lewis continued: “Additionally, we are making progress and
are working to compile an Investigational New Drug (IND) package,
including the development of a phase 2 trial protocol, with the
objective for the Company to file an IND with the FDA oncology
division for the treatment of recurrent or metastatic head and neck
cancer for belapectin in combination with Keytruda®, an immune
checkpoint inhibitor. The lack of current treatments for these
patients, the low response rates of monotherapy with check-point
inhibitors, the limited number of therapies in development, and the
resulting very high medical need make this an important area for
new combination therapies.”
Financial Results
For the three months ended March 31, 2022, the Company
reported a net loss applicable to common stockholders of $9.9
million, or ($0.17) per share, compared to a net loss applicable to
common stockholders of $6.3 million, or ($0.11) per share for the
three months ended March 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 three months
ended March 31, 2022, was $8.1 million compared with $4.9
million for the three months ended March 31, 2021. 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, 2022, were $1.9 million,
compared to $1.4 million for the three months ended March 31, 2021.
The increase was primarily due to non-cash stock-based compensation
expense.
As of March 31, 2022, the Company had $31.6
million of cash and cash equivalents. The Company believes it
has sufficient cash to fund currently planned operations and
research and development activities through at least May 16,
2023.
The Company expects that it will require more cash to fund
operations after May 16, 2023, and believes it will be able to
obtain additional financing as needed. Currently, we expect to
require an additional approximately $40-$45 million to cover
costs of the NAVIGATE trial to reach the planned interim analysis
estimated to occur in mid-2024, along with drug manufacturing and
other research and development 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
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 March 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
Operating expenses: |
|
|
Research and development |
$ |
8,058 |
|
$ |
4,899 |
|
General and administrative |
|
1,877 |
|
|
1,418 |
|
Total operating expenses |
|
9,935 |
|
|
6,317 |
|
Total operating loss |
|
(9,935 |
) |
|
(6,317 |
) |
Other income (expense): |
|
|
Interest income |
|
1 |
|
|
1 |
|
Interest expense |
|
(227 |
) |
|
(22 |
) |
Change in fair value of derivatives |
|
229 |
|
|
— |
|
Total other income |
|
3 |
|
|
(21 |
) |
Net loss |
$ |
(9,932 |
) |
$ |
(6,338 |
) |
Preferred stock dividends |
|
16 |
|
|
(2 |
) |
Net loss applicable to common stock |
$ |
(9,916 |
) |
$ |
(6,340 |
) |
Basic and diluted net loss per share |
$ |
(0.17 |
) |
$ |
(0.11 |
) |
Shares used in computing basic and diluted net loss per share |
|
59,354 |
|
|
57,132 |
|
Condensed Consolidated Balance Sheet Data
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
31,606 |
|
$ |
39,648 |
Total assets |
|
33,615 |
|
|
41,827 |
Total current liabilities |
|
9,535 |
|
|
9,033 |
Total liabilities |
|
39,808 |
|
|
39,211 |
Total redeemable, convertible
preferred stock |
|
1,723 |
|
|
1,723 |
Total stockholders’ (deficit)
equity |
$ |
(7,916 |
) |
$ |
893 |
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