Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of
therapeutics that target galectin proteins, today reported
financial results for its second fiscal quarter, which ended June
30, 2018, and provided a business update. 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.
Key Highlights
- Company has initiated Phase 3 preparation of GR-MD-02 for NASH
cirrhosis
- Reported a net operating loss of $4.1M and has sufficient cash
resources to fund operations at least through June 2019
- Has received notice of issuance of additional patents
surrounding GR-MD-02
- Board of Directors elected Richard E. Uihlein as Chairman and
Kevin D. Freeman as Vice Chairman
- Engaged Back Bay Life Science Advisors to pursue strategic
alternatives
"The second quarter was another active quarter with
significant progress advancing our proprietary compound GR-MD-02 to
a pivotal Phase 3 trial and preparing for the opportunities it
represents to our business,” said Dr. Harold H. Shlevin,
Ph.D., President and Chief Executive Officer of Galectin
Therapeutics. “Most importantly, we announced that we are
proceeding with plans for a Phase 3 clinical trial program with
GR-MD-02 in NASH cirrhosis, incorporating advice and guidance
obtained in a meeting with the US Food and Drug Administration
(FDA), and based on the positive effects of GR-MD-02 on HVPG and
the possible prevention or postponement of development of
esophageal varices in the Phase 2 NASH-CX trial, which we believe
is the first large, randomized clinical trial of any drug to
demonstrate a clinically meaningful improvement in these
patients.”
Richard Uihlein, Chairman of the Board, added,
“Galectin’s new leadership is focused on planning and conducting
additional supportive work to prepare for a Phase 3 trial for
GR-MD-02 in NASH cirrhosis based on the positive effects of
GR-MD-02 on HVPG. However, we believe our galectin-3 inhibitor
GR-MD-02 has widespread applicability for a range of diseases.
Consequently, we are simultaneously pursuing other opportunities
and, most immediately, anticipate results on our combination
immunotherapy clinical trial. We also now have a potential pathway
forward in pulmonary fibrosis, where GR-MD-02 was recently granted
a patent. Finally, on behalf of the Board, we are extremely pleased
that Dr. Harold Shlevin has agreed to take on the broader role of
CEO, and we are all confident in his ability to drive Galectin
Therapeutics forward across all our multiple programs.”
Expected Upcoming Milestones
Enrollment in cohort 3 (GR-MD-02 8 mg/kg) of the pembrolizumab
combination immunotherapy Phase 1 clinical trial has completed and
will likely include up to 10 evaluable patients with melanoma and
head & neck cancer, to provide a larger group of and different
type of cancer patients in this initial evaluation. It is hoped
that these additional data can be reported in the near term when we
anticipate a decision on progressing this program to the next
phase.
Summary of Key Development Programs and
Updates
- Announced that we are proceeding with plans for a Phase 3
clinical trial program with our galectin-3 inhibitor GR-MD-02 in
NASH cirrhosis, incorporating advice and guidance obtained in a
meeting with the FDA. Details of the Phase 3 clinical trial
design, including projected timings and costs, will be announced
once the planning phase has been completed and the Company has
submitted a final clinical trial protocol with the FDA.
- At the Company’s Annual Meeting of Shareholders on May 22,
2018, it was announced that the Board of Directors had elected
Richard E. Uihlein, who has been a member of the Board since 2017,
as Chairman and Kevin D. Freeman, who has been a member of the
Board since 2011, as Vice Chairman.
- The Company received notice of issuance of U.S. Patent
Number 9,968,631 titled "Method and Treatment of Pulmonary
Fibrosis,” covering method of use of GR-MD-02 as a means to treat
pulmonary fibrosis. Pharmaceutical companies may have an interest
in this molecule as there is a sizeable section of the population
in need of treatment and well defined regulatory pathways for
approval of agents to treat pulmonary fibrosis.
- The Company received notice of issuance on May 22, 2018 of U.S.
Patent Number 9,974,802 titled “Composition of Novel Carbohydrate
Drug for Treatment of Human Diseases” covering a composition
comprising its galectin inhibitor, GR-MD-02, and an
immunotherapeutic agent or a vaccine directed against CTLA4, OX40,
PD-1, PD-L1 or combinations thereof (and the composition for use in
cancer disorders). This patent complements USP
9,872,909 issued on January 23, 2018 which covers
method of treating cancer by administering GR-MD-02 and an
immunomodulatory agent wherein the cancer is one of
gastrointestinal cancer, pancreatic cancer, bile duct cancer,
sarcoma, myosarcoma, breast cancer, lung cancer, head and neck
cancer, mouth cancer, skin cancer, melanoma, kidney cancer, urinary
tract cancer, prostate cancer, testicular cancer, ovarian cancer,
endometrial cancer, neurological cancer, endocrine gland cancer,
bone cancer, hematological cancers, multiple myeloma, and
myelofibrosis.
- The Company has engaged Back Bay Life Science Advisors, a
Boston-based, internationally focused integrated strategy and
transaction advisory organization, to support the Company’s
exploration of strategic alternatives.
Dr. Shlevin concluded, “Galectin Therapeutics has
developed a novel compound, GR-MD-02, a galectin-3 inhibitor, which
we believe has the potential to be effective in treating a wide
range of diseases wherein elevated levels of galectin protein and
inflammation play key roles in the pathophysiology of the diseases.
Most immediately, we are focused on advancing our Phase 3 trial in
NASH Cirrhosis. However, we continue to investigate a variety of
other preclinical applications where research shows that GR-MD-02’s
antifibrotic capabilities may help provide more effective treatment
in a variety of conditions. We believe this is the best path to
build value in our overall galectin franchise.”
Financial Results
For the three months ended June 30, 2018, the
Company reported a net loss applicable to common stockholders of
$4.1 million, or $0.11 per share, compared with a net loss
applicable to common stockholders of $4.8 million, or $0.14 per
share, for the three months ended June 30, 2017. The decrease is
largely due to lower research and development expenses primarily
related to the winding down of the Phase 2 NASH clinical program
somewhat offset by higher non-cash stock compensation expenses.
Research and development expense for the three
months ended June 30, 2018 was $1.5 million, compared with $3.4
million for the three months ended June 30, 2017. The decrease
primarily reflects lower research and development expenses
primarily related to the winding down of the Phase 2 NASH clinical
program somewhat offset by higher non-cash stock compensation
expenses.
General and administrative expense for quarter was
$2.3 million, compared with $1.1 million for the prior year, with
the increase being primarily related to higher investor relations,
business development and non-cash stock compensation expenses.
As of June 30, 2018, the Company had $10.5 million
of non-restricted cash and cash equivalents. The Company believes
it has sufficient cash on hand in addition to its $10 million line
of credit (untapped at June 30, 2018) to fund currently planned
operations and research and development activities through at least
June 30, 2019.
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 (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. 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 severe atopic dermatitis, moderate-to-severe plaque
psoriasis, and in 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
GR-MD-02 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 the treatment of severe atopic
dermatitis, moderate-to-severe plaque psoriasis and 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 Galectin may not be successful in developing effective
treatments and/or obtaining the requisite approvals for the use of
GR-MD-02 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 may not produce positive results in a timely
fashion, if at all, and could prove 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. 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, 2017, 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.
Contacts:Jack Callicutt, Chief Financial
Officer(678) 620-3186ir@galectintherapeutics.com.
Galectin Therapeutics and its associated logo is a
registered trademark of Galectin Therapeutics Inc.
Condensed Consolidated Statements of
Operations
|
Three Months EndedJune
30, |
Six Months EndedJune
30, |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
1,476 |
|
$ |
3,444 |
|
$ |
3,774 |
|
$ |
7,216 |
|
General
and administrative |
|
2,283 |
|
|
1,070 |
|
|
4,163 |
|
|
2,244 |
|
Total
operating expenses |
|
3,759 |
|
|
4,514 |
|
|
7,937 |
|
|
9,460 |
|
Total
operating loss |
|
(3,759 |
) |
|
(4,514 |
) |
|
(7,937 |
) |
|
(9,460 |
) |
Other
income: |
|
|
|
|
Interest
and other |
|
(81 |
) |
|
6 |
|
|
(161 |
) |
|
15 |
|
Total
other income |
|
(81 |
) |
|
6 |
|
|
(161 |
) |
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(3,840 |
) |
$ |
(4,508 |
) |
$ |
(8,098 |
) |
$ |
(9,445 |
) |
Preferred stock dividends and accretion costs |
|
(268 |
) |
|
(301 |
) |
|
(553 |
) |
|
(573 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
applicable to common stock |
$ |
(4,108 |
) |
$ |
(4,809 |
) |
$ |
(8,651 |
) |
$ |
(10,018 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
$ |
(0.11 |
) |
$ |
(0.14 |
) |
$ |
(0.23 |
) |
$ |
(0.29 |
) |
Shares used in computing basic and diluted net loss per share |
|
38,227 |
|
|
34,692 |
|
|
37,755 |
|
|
34,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Data
|
|
June 30, 2018 |
|
December 31, 2017 |
|
|
(in thousands) |
Cash and
cash equivalents |
$ |
10,497 |
$ |
3,053 |
|
Total
assets |
|
11,210 |
|
4,161 |
|
Total
current liabilities |
|
1,435 |
|
2,968 |
|
Total
liabilities |
|
1,435 |
|
2,968 |
|
Total
redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
|
Total
stockholders’ equity |
$ |
8,052 |
$ |
(530 |
) |
|
|
|
|
|
|
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