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, 2020. 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.
Harold H. Shlevin, Ph.D., President and Chief Executive Officer
of Galectin Therapeutics, said, “We are excited to have recently
submitted the NASH-RX clinical trial protocol to the U.S. Food and
Drug Administration (FDA). Taken together, the adaptations in this
protocol should optimize the conduct of the NASH-RX trial to give
belapectin (GR-MD-02) the best opportunity to show a positive
therapeutic effect. Most notably, if the results of the NASH-RX
trial are compelling, there could be the potential for accelerated
FDA approval and/or partnership opportunity with a large
pharmaceutical company. While the filing currently anticipates
clinical trials will begin in the second quarter of this year, this
is a particularly challenging time to start a new clinical trial.
Factors beyond our control, specifically related to the COVID-19
pandemic, may delay the trial’s initiation. Notwithstanding that,
we remain optimistic in moving forward. The unmet medical need for
an effective treatment for patients with NASH cirrhosis remains an
important motivation.”
Richard E. Uihlein, Chairman of the Board, added, “I am very
proud of our entire team at Galectin Therapeutics. Their efforts,
along with invaluable assistance from our Co-Primary Investigators
and based on input received from the FDA, resulted in a trial
protocol which is designed to give our drug the best chance of
demonstrating efficacy and safety. Additionally, it should also
help to maximize patient retention and enhance participation. Our
goal of slowing or otherwise preventing the development of new
varices in our target clinical trial patient population, NASH
patients with compensated cirrhosis, if attained, can help patients
to avoid further cirrhosis complications. These include variceal
bleeding and other decompensating events accompanying disease
progression, which could ultimately lead to liver failure. Since
there are currently no treatment options for NASH cirrhosis, liver
transplantation is the only viable option. Alternatively, a
reduction in the number of patients who progress to liver failure
has the potential to save many lives.”
Belapectin (formerly known as GR-MD-02) is the first drug that
has been shown to prevent the development of esophageal varices in
patients with compensated NASH cirrhosis. If confirmed, these
results would constitute a significant benefit for patients.
NASH-RX Trial Update
The NASH-RX trial will use an adaptive design, confirm dose
selection, and reaffirm the efficacy data observed in the NASH-CX
trial and, with pre-planned adaptations, inform the larger Phase 3
trial component.
- The protocol for a seamless adaptively-designed Phase 2b/3
clinical study, the NASH-RX trial, was submitted to the U.S. Food
and Drug Administration (FDA) on April 30, 2020. Details are
available at www.clinicaltrials.gov NCT 04365868
- The filing currently anticipates clinical trials will begin in
the second quarter of this year.
- The design of this trial reflects the unmet medical needs of
the target patient population for belapectin treatment: NASH
patients with compensated cirrhosis who develop esophageal varices.
Bleeding varices are a cause of death in about one-third of
cirrhotic patients. Currently, there is no approved treatment for
preventing varices in these patients. The development of new
varices reflects the progression of hepatic cirrhosis and thus
portends the development of other cirrhosis complications and
outcomes such as significant ascites, hepatic encephalopathy, and
eventual liver failure.
- In addition on March 31, 2020, the Company also filed with the
FDA a protocol for the hepatic impairment study
(www.clinicaltrials.gov NCT04332432), with the study also
currently anticipated to begin in the second quarter of this
year.
Galectin Therapeutics will share more details about the protocol
at the time the clinical trial begins.
Other Updates
- Pol F. Boudes, M.D. has now joined the company as Chief Medical
Officer, where his background in NASH and other liver disease drug
development has proven instrumental to the filing of the NASH-RX
protocol and is expected to add significantly to the conduct of the
trial.
New Articles Published to the Company’s
Website
- Shamseddeen H, Vilar-Gomez E, Chalasani N, Myers RP,
Subramanian GM, Shlevin HH, Allgood AE, Orman ES (2020) Spontaneous
Fluctuations in Liver Biochemistries in Patients with Compensated
NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring.
Drug Safety 43:281–290. doi.org/10.1007/s40264-019-00896-1
- Patients with cirrhosis may have spontaneous fluctuations in
liver enzymes, which may confound the detection of drug-induced
liver injury (DILI), but these fluctuations have not been
described.
- Study concluded that spontaneous liver enzyme abnormalities are
common in patients with NASH cirrhosis in clinical trials, and
these abnormalities rarely met criteria for DILI suspicion. Further
work to better define these abnormalities and continued vigilance
to detect DILI in this population is needed.
- Chalasani N, Abdelmalek MF, Garcia-Tsao G, Vuppalanchi R,
Alkhouri N, Rinella M, Noureddin M, Pyko M, Shiffman M, Sanyal A,
Allgood A, Shlevin H, Horton R, Zomer E, Irish W, Goodman Z,
Harrison SA, Traber PG (2019) Effects of Belapectin, an Inhibitor
of Galectin-3, in Patients with Nonalcoholic Steatohepatitis With
Cirrhosis And Portal Hypertension. Gastroenterology
S0016-5085(19)41895-7.
Shelf Registration Statement
The Company has filed a “shelf” registration statement on Form
S-3 (the “Registration Statement”) with the Securities and Exchange
Commission (the “SEC”) for the registration of up to $100.0 million
of any combination of shares of the Company’s common stock,
warrants, or rights (collectively, the “Securities”). The
Registration Statement is being filed to replace the Company’s
current “shelf” registration statement, which expires on June 1,
2020.
When the Registration Statement is declared effective by the
SEC, Securities may be offered, separately or together, from time
to time and in one or more offerings. A prospectus supplement
related to the offer and sale of shares of common stock to be sold
pursuant to an At The Market Issuance Sales Agreement with H. C.
Wainwright & Co., LLC, is included within the Registration
Statement. The terms of any other offering, including the specific
terms and prices of the Securities, will be determined at the time
of such offering and be made solely by means of the prospectus
included in the Registration Statement and any prospectus
supplement that may be filed with the SEC relating to such
offering.
The Registration Statement has been filed with the SEC but has
not yet become effective. The Securities may not be sold, nor may
offers to buy the Securities be accepted, prior to the time the
Registration Statement becomes effective. This press release shall
not constitute an offer to sell or the solicitation of an offer to
buy, nor shall there be any sale of the Securities in any state in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities law of any such
state.
Financial Results
For the three months ended March 31, 2020, the Company
reported a net loss applicable to common stockholders of $3.6
million, or ($0.06) per share, compared to a net loss applicable to
common stockholders of $9.1 million, or ($0.20) per share for the
three months ended March 31, 2019. The decrease is largely due to a
one-time, non-cash $6.6 million charge in the period ended March
31, 2019, related to extending the life of warrants held by the
holder of the Company’s Series B preferred stock in connection with
the conversion of all the Series B preferred stock into common
stock, somewhat offset by an increase in 2020 research and
development expense related to the Company’s planned NASH-RX
trial.
Research and development expense for the three months
ended March 31, 2020, was $2.1 million compared with $0.6
million for the three months ended March 31, 2019. The increase was
primarily due to costs related to our NASH-RX clinical trial
planning and site start-up and qualification processes globally,
along with preparations and some preclinical activities incurred in
support of the planned clinical program, such as development and
reproductive toxicity studies, clinical supplies and other
supportive activities. General and administrative expenses for the
three months ended March 31, 2020, were $1.4 million, down
from $1.7 million for the three months ended March 31, 2019,
primarily due to a decrease in legal expenses partially offset by
an increase in insurance expenses.
As of March 31, 2020, the Company had $43.3
million of cash and cash equivalents. 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, 2021.
The Company expects that it will require more cash to fund
operations after September 30, 2021, and believes it will be able
to obtain additional financing as needed. The total cost to obtain
the interim analysis data of the planned trial, including general
overhead, is currently estimated to be approximately
$125 million; however, the costs and timing of such trial are
not yet completely finalized. These costs will require additional
funding. There can be no assurance that we will be successful in
obtaining financing to support our operations beyond September 30,
2021, or, if available, that any such financing will be on terms
acceptable 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 fatty liver disease 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. The drug binds to galectin
proteins and disrupts their function. Preclinical data in animals
have shown that GR-MD-02 has robust treatment effects in reversing
liver fibrosis and cirrhosis.About Fatty Liver Disease with
Advanced Fibrosis and CirrhosisNon-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 TherapeuticsGalectin 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 StatementsThis 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 limit access to
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, 2019, 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, |
|
2020 |
2019 |
|
|
Operating expenses: |
|
|
Research and development |
$ |
2,144 |
|
$ |
646 |
|
General and administrative |
|
1,440 |
|
|
1,721 |
|
Total operating expenses |
|
3,584 |
|
|
2,367 |
|
Total operating loss |
|
(3,584 |
) |
|
(2,367 |
) |
Other income (expense): |
|
|
Interest income |
|
50 |
|
|
14 |
|
Interest expense |
|
(22 |
) |
|
(22 |
) |
Total other income |
|
28 |
|
|
(8 |
) |
Net loss |
$ |
(3,556 |
) |
$ |
(2,375 |
) |
Preferred stock dividends |
|
6 |
|
|
(96 |
) |
Warrant modification |
|
- |
|
|
(6,622 |
) |
Net loss applicable to common stock |
$ |
(3,550 |
) |
$ |
(9,093 |
) |
Basic and diluted net loss per share |
$ |
(0.06 |
) |
$ |
(0.20 |
) |
Shares used in computing basic and diluted net loss per share |
|
56,956 |
|
|
44,975 |
|
Condensed Consolidated Balance Sheet Data
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
43,328 |
$ |
47,480 |
Total assets |
|
44,111 |
|
48,467 |
Total current liabilities |
|
1,316 |
|
2,820 |
Total liabilities |
|
1,358 |
|
2,872 |
Total redeemable, convertible
preferred stock |
|
1,723 |
|
1,723 |
Total stockholders’
equity |
$ |
41,030 |
$ |
43,872 |
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