Galectin Therapeutics Reports Financial Results for the Quarter Ended June 30, 2020, and Provides Business Update
August 10 2020 - 8:00AM
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 June 30, 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 initiated
the NASH-RX trial, having enrolled our first patient in June and
continuing to enroll patients at several of our sites in our
clinical trial of belapectin targeting cirrhotic NASH patients. 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 pharmaceutical company. Later this quarter, we
plan to host a conference call with the Investment Community for a
more thorough discussion of the NASH-RX trial, its current status,
our updated strategy, and to take questions.”
Richard E. Uihlein, Chairman of the Board, added, “The protocol
of the NASH-RX trial has been designed to provide belapectin with
the best chance to demonstrate efficacy and safety, and I am very
pleased this trial is now underway. Belapectin is targeting NASH
cirrhosis patients, those who can no longer expect to benefit from
increased exercise or an improved diet as may benefit many of those
with earlier stages of NASH. And, 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. Consequently, we believe our drug
targets NASH at a very critical point of its development, as it
represents an opportunity to prevent the progression of liver
damage, and thereby save lives.”
The NASH-RX trial will use an adaptive design to 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. In June 2020, we enrolled our first patients in
the NASH-RX trial. NASH-RX is expected to enroll approximately 315
NASH patients in the Phase 2b part of the trial at approximately
130 sites in 12 countries in North America, Europe, Asia and
Australia.
Galectin plans to host a conference call with the investment
community in the third quarter to provide a more comprehensive
description and update on the status of the trial and to take
questions. The date and time of the call and how to participate
will be published in advance of the planned call.
Financial Results
For the three months ended June 30, 2020, the Company
reported a net loss applicable to common stockholders of $6.2
million, or ($0.11) per share, compared to a net loss applicable to
common stockholders of $3.1 million, or ($0.06) per share for the
three months ended June 30, 2019. The increase is due to 2020
research and development expense related to the Company’s NASH-RX
trial. Research and development expense for the three months
ended June 30, 2020 was $4.7 million compared with $1.5
million for the three months ended June 30, 2019. The increase was
primarily due to costs related to our NASH-RX clinical trial, along
with preparations and some preclinical activities incurred in
support of the clinical program, such as development and
reproductive toxicity studies, clinical supplies and other
supportive activities. General and administrative expenses for the
three months ended June 30, 2020, were $1.4 million, down from
$1.5 million for the three months ended March 31, 2019, primarily
due to a decrease in stock-based compensation expenses. As
of June 30, 2020, the Company had $40.8 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 $90 million. 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 belapectin 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 EndedJune 30, |
Six Months EndedJune 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
Research and development |
$ |
4,681 |
|
$ |
1,522 |
|
$ |
6,825 |
|
$ |
2,168 |
|
General and administrative |
|
1,421 |
|
|
1,498 |
|
|
2,861 |
|
|
3,219 |
|
Total operating expenses |
|
6,102 |
|
|
3,020 |
|
|
9,686 |
|
|
5,387 |
|
Total operating loss |
|
(6,102 |
) |
|
(3,020 |
) |
|
(9,686 |
) |
|
(5,387 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
9 |
|
|
43 |
|
|
59 |
|
|
57 |
|
Interest expense |
|
(21 |
) |
|
(21 |
) |
|
(43 |
) |
|
(43 |
) |
Total other income |
|
(12 |
) |
|
22 |
|
|
16 |
|
|
14 |
|
Net loss |
$ |
(6,114 |
) |
$ |
(2,998 |
) |
$ |
(9,670 |
) |
$ |
(5,373 |
) |
Preferred stock dividends |
|
(66 |
) |
|
(67 |
) |
|
(60 |
) |
|
(163 |
) |
Warrant modification |
|
|
|
|
(6,622 |
) |
Net loss applicable to common stock |
$ |
(6,180 |
) |
$ |
(3,065 |
) |
$ |
(12,158 |
) |
$ |
(12,158 |
) |
Basic and diluted net loss per share |
$ |
(0.11 |
) |
$ |
(0.06 |
) |
$ |
(0.17 |
) |
$ |
(0.26 |
) |
Shares used in computing basic and diluted net loss per share |
|
57,035 |
|
|
50,301 |
|
|
56,995 |
|
|
47,653 |
|
Condensed Consolidated Balance Sheet Data
|
|
June 30, 2020 |
|
December 31, 2019 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
40,768 |
$ |
47,480 |
Total assets |
|
41,317 |
|
48,467 |
Total current liabilities |
|
4,274 |
|
2,820 |
Total liabilities |
|
4,305 |
|
2,872 |
Total redeemable, convertible
preferred stock |
|
1,723 |
|
1,723 |
Total stockholders’
equity |
$ |
35,289 |
$ |
43,872 |
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