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 September 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.
Joel Lewis, Chief Executive Officer and President of Galectin
Therapeutics, said, “With the June launch of our innovative NASH-RX
clinical trial, we now have one of the very few, if not only,
active late stage trial of patients with compensated
NASH-cirrhosis, where the medical need is greatest.
Continuing our progress, the first patient was randomized in August
and we are enrolling patients and adding sites to this global
clinical trial of belapectin, our proprietary galectin-3 inhibiting
compound. We believe our innovative trial design, experienced
medical and clinical teams and clear primary endpoint provide a
strong foundation for success. A positive result will be very
clinically relevant. If the trial shows that belapectin is
effective and safe, it will be a medical breakthrough for patients
with NASH cirrhosis.”
“As I close out my first quarter as the head of Galectin
Therapeutics, I want to reiterate how excited I am to be leading
this team,” concluded Lewis. “I also want to thank the
investigators and patients who will participate in our NASH-RX
trial. Without your commitment, there is no way the company
would be where we are today nor would we have a future.”
Richard E. Uihlein, Chairman of the Board, added, “Galectin
Therapeutics is competitively well-positioned in the industry, and
we are fortunate to have Joel leading these efforts. I am also glad
to welcome Mr. Richard Zordani and Dr. Elissa Schwartz to our Board
of Directors, both seasoned professionals that will strengthen our
financial and clinical capabilities, respectively.”
“Success in NASH cirrhosis potentially opens new treatment
possibilities for belapectin's use in other types of liver
cirrhosis and in other forms of organ fibrosis affecting kidney,
lung, as well as other organs. More research is warranted to expand
our understanding of galectins and the role that a galectin-3
inhibitor like belapectin may play in preventing and treating
disease. Thus, our NASH-RX trial will set the stage for realizing
the full potential of our proprietary compound, belapectin.”
Summary of Key Development Programs and
Updates
- On June 30 announced that we had enrolled our first patients in
the NASH-RX trial. NASH-RX is an international, seamless,
adaptively-designed Phase 2b/3 trial of our galectin-3 inhibitor
belapectin (GR-MD-02), the company's lead compound, in nonalcoholic
steatohepatitis (NASH) cirrhosis patients who have clinical signs
of portal hypertension and are at risk of developing esophageal
varices. Belapectin had previously been shown that it could prevent
the development of new varices in this patient population in the
Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:1334–1345
or https://doi.org/10.1053/j.gastro.2019.11.296).
- Announced the appointment of current board member, Joel Lewis,
to the position of Chief Executive Officer (CEO) and President. In
this position, Mr. Lewis will set corporate strategy and oversee
operations, most importantly the Company’s global NASH-RX
adaptively-designed trial for the prevention of varices in NASH
cirrhosis patients using its proprietary galectin-3 inhibiting
compound, belapectin (GR-MD-02).
- Engaged Dr. Harold Shlevin, who retired from the CEO position,
to a consulting agreement through which he has agreed to devote
significant effort to advancing the NASH-RX trial and will remain a
member of the Board of Directors.
- Enhanced its Board of Directors with the addition of two
additional directors, Mr. Richard Zordani and Dr. Elissa Schwartz.
Mr. Zordani is a seasoned financial executive with extensive public
accounting and Family Office experience and has assumed the role of
Audit Committee Chairman. Dr. Schwartz has extensive experience in
epidemiology and clinical research, biomathematics, and
biostatistics, which complements the Company's clinical development
capabilities.
- Hosted a virtual conference call and webinar with the
investment community on September 29th that provided a
comprehensive description and update on the status of the NASH-RX
trial and introduced our new CEO, Joel Lewis. A replay
of the Investor Call can be accessed at this link:
https://edge.media-server.com/mmc/p/hmudntyg
About the NASH-RX Trial
- The NASH-RX trial will use a seamless, adaptive design to
confirm dose selection and reaffirm the observed efficacy of
belapectin to prevent the development of esophageal varices in the
NASH-CX trial. Pre-planned adaptations will inform the larger Phase
3 trial component. NASH-RX is expected to enroll approximately 315
NASH cirrhotic patients in the Phase 2b part of the trial at
approximately 130 sites in 12 countries in North America, Europe,
Asia and Australia.
Financial Results
For the three months ended September 30, 2020, the Company
reported a net loss applicable to common stockholders of $5.955
million, or ($0.10) per share, compared to a net loss applicable to
common stockholders of $2.819 million, or ($0.05) per share for the
three months ended September 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 September 30, 2020 was $4.780 million compared with
$1.503 million for the three months ended September 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 September 30, 2020, were $1.146 million,
down from $1.360 million for the three months ended September 30,
2019, primarily due to a decrease in stock-based compensation
expenses.
As of September 30, 2020, the Company had $32.6
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 December 31, 2021.
The Company expects that it will require more cash to fund
operations after December 31, 2021 and believes it will be able to
obtain additional financing as needed. Currently, we expect to
require an additional approximately $40 million to cover costs of
the trial to reach the planned interim analysis estimated to occur
in the second quarter of 2023 along with drug manufacturing and
other scientific support activities and general and administrative
costs. These costs will require additional funding. There can be no
assurance that we will be successful in obtaining financing to
support our operations beyond December 31, 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 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. Galectin-3 has a
significant role in cancer and the Company is supporting a Phase 1
study in combined immunotherapy of belapectin and Keytruda in
treatment of advanced melanoma and in head and neck cancer.
About Non-alcoholic steatohepatitis (NASH) with Advanced
Fibrosis and CirrhosisNASH 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 currently the only
curative treatment available. 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 for
NASH cirrhosis 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 EndedSeptember
30, |
Nine Months EndedSeptember
30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,780 |
|
$ |
1,503 |
|
$ |
11,605 |
|
$ |
3,671 |
|
General and administrative |
|
1,146 |
|
|
1,360 |
|
|
4,007 |
|
|
4,579 |
|
Total operating expenses |
|
5,926 |
|
|
2,863 |
|
|
15,612 |
|
|
8,250 |
|
Total operating loss |
|
(5,926 |
) |
|
(2,863 |
) |
|
(15,612 |
) |
|
(8,250 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
5 |
|
|
101 |
|
|
64 |
|
|
158 |
|
Interest expense |
|
(22 |
) |
|
(22 |
) |
|
(65 |
) |
|
(65 |
) |
Total other income |
|
(17 |
) |
|
79 |
|
|
(1 |
) |
|
93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,943 |
) |
$ |
(2,784 |
) |
$ |
(15,613 |
) |
$ |
(8,157 |
) |
Preferred stock dividends |
|
(12 |
) |
|
(35 |
) |
|
(72 |
) |
|
(198 |
) |
Warrant modification |
|
|
|
|
(6,622 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock |
$ |
(5,955 |
) |
$ |
(2,819 |
) |
$ |
(15,685 |
) |
$ |
(14,977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.10 |
) |
$ |
(0.05 |
) |
$ |
(0.28 |
) |
$ |
(0.27 |
) |
Shares used in computing basic and diluted net loss per share |
|
57,047 |
|
|
56,631 |
|
|
57,013 |
|
|
55,494 |
|
Condensed Consolidated Balance Sheet Data
|
|
September 30,2020 |
|
|
December 31,2019 |
|
|
|
(in thousands) |
Cash and cash
equivalents |
$ |
32,556 |
|
$ |
47,480 |
|
Total assets |
|
34,049 |
|
|
48,467 |
|
Total current liabilities |
|
2,488 |
|
|
2,820 |
|
Total liabilities |
|
2,507 |
|
|
2,872 |
|
Total redeemable, convertible
preferred stock |
|
1,723 |
|
|
1,723 |
|
Total stockholders’
equity |
$ |
29,819 |
|
$ |
43,872 |
|
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