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 year ended
December 31, 2019. These results are included in the Company's
Annual Report on Form 10-K, 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, “The focus of the
past few months has been on finalizing the refinements to our
planned NASH-RX trial based on feedback from the U.S. Food and
Drug Administration (FDA). Our Adaptive-Designed Phase 2b/3
trial protocol is nearly complete, and we anticipate initiating the
trial in the second quarter of 2020. We have been very successful
working with our partners to modify our initial trial design,
incorporating a new biostatistics element to verify the rate of
varices development and accordingly adjust trial sizing to help
assure a key assumption related to the rate of varices development
is met. Most recently, we strengthened our executive team with the
addition of Dr. Pol F. Boudes, a Chief Medical Officer who has
experience running NASH drug trials. In addition, as a result of
the modifications to our trial, our clinical research organization
Covance has been able to identify additional international clinical
trial sites. Drug manufacturing capacity has been established to
meet the needs of the entire trial. 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.”
Richard E. Uihlein, Chairman of the Board, added,
“I am extremely pleased with the progress achieved over the past
few months. We are now in the final stages of finalizing our
NASH-RX trial, which improves the likelihood of showing
belapectin’s effects. And, with the recent addition of Dr. Boudes
as Chief Medical Officer, we have a strong executive with extensive
experience conducting trials of this nature. As always, our goal is
to provide a therapy for the growing NASH epidemic around the
world.”
NASH-RX Trial Update The NASH-RX
trial is planned to 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 adaptive design being considered allows pre-planned
adjustments of the trial that may include, amongst other factors,
optimization of dose selection, confirmation of efficacy and proof
of concept observed in the NASH-CX trial, optimized sizing and
statistical powering of the Phase 3 component, and possible
inclusion of more advanced cirrhotic patients. We believe that
these adaptations taken together should optimize conduct of the
NASH-RX trial giving belapectin (GR-MD-02) the best opportunity to
show a positive therapeutic effect. 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.
The trial protocol is based on feedback from
several interactions with the FDA during the last few months of
2019, including the November 14, 2019, telephone conference which
included the FDA and Company representatives along with its
co-primary investigators, biostatistical experts and other experts
at Covance. In this meeting, the FDA indicated the new design was
reasonable (subject to review of the protocol), and FDA indicated
that they were still supportive of the surrogate end-point concepts
originally proposed.
We believe the study design potentially could
improve the likelihood of showing drug efficacy because:
- It clarifies and reaffirms NASH-CX efficacy and safety at two
distinct drug doses supported by robust pharmacokinetic
analysis
- It provides for appropriate selection of optimal dose – e.g.,
single dose (2 or 4 mg/kg) for Phase 3 component
- A separate Hepatic Impairment study may allow inclusion of more
severe patients who are believed to have a much higher rate of
esophageal varices progression and bleeding and other
decompensating events
- Reduced frequency of esophagogastroduodenoscopys (EGD),
elimination of biopsy endpoints and elimination of hepatic venous
pressure gradient (HVPG) testing may make it easier to enroll trial
patients and retain these patients during the duration of the
trial
- Adaptation to size and power calculations based on sample size
re-estimation and the interim analysis will allow better estimates
of Phase 3 cohort sizing and of statistical power
- A planned interim analysis after 18 months of completed
treatment will assess affirmation of Phase 2 efficacy and safety
results, help select a single optimal dosage, and inform the Phase
3 stage of the study, including its size
In the Phase 3 component of this trial, the primary
endpoint is development of new esophageal varices. Patients already
enrolled for the Phase 2b component of the trial will continue on
the selected single dose into the Phase 3 component of the trial.
Patient selection for both Phase 2b and 3 components will be based
on routine clinical signs of portal hypertension, including,
amongst others, the presence or absence of varices, depressed
platelet count (thrombocytopenia), enlargement of the spleen size
and evidence of collateral blood vessels by imaging. The current
study design and protocol are subject to modification after review
by FDA.
The focus and goal of the therapeutic program is to
prevent the development of large esophageal varices, which are
strongly correlated with patient mortality due to sudden and severe
bleeding. Based on the results of the NASH-CX trial, the clinical
program will focus on patients who are at increased risk of
developing varices, i.e. patients who have clinical signs of portal
hypertension, such as low platelet counts or increased spleen size
(splenomegaly).
The key milestones and associated target dates for
the NASH-RX trial will be announced as elements of design of the
trial are finalized based on the recent FDA feedback. However, we
currently expect the first patient to be initiated in the second
quarter of 2020. The study overall will likely involve
approximately 130 sites in 11 countries in North America, Europe,
Asia, and Australia.
Other Updates
- Announced that Pol F. Boudes, M.D. has been appointed Chief
Medical Officer - a key development for the company as it nears
launch of its NASH-RX trial, an adaptively-designed Phase 3 trial
in NASH cirrhosis. Dr. Boudes’ diverse background in drug
development, especially his experience in NASH and other liver
diseases, bolsters Galectin's global advanced clinical development
of belapectin for NASH cirrhosis. Peer-reviewed
publication, Scientific Presentations and Conferences
- Gastroenterology, a prominent journal in the field of
gastrointestinal disease, published a peer reviewed paper titled,
“Effects of Belapectin, an Inhibitor of Galectin-3, in Patients
with Nonalcoholic Steatohepatitis with Cirrhosis and Portal
Hypertension,” highlighting the potential prevention of esophageal
varices of its NASH-CX Phase 2 clinical trial in NASH cirrhosis. We
were greatly honored that such a prestigious, peer-reviewed
publication felt the quality of our science merited the
industry-wide attention they provide.
- Initial results of the efforts at Galectin Sciences LLC (our
majority-owned subsidiary) were presented by Dr. E. Zomer, Ph.D.,
Vice President, Discovery Research and Product
Development, at the 3rd Annual Anti-Fibrotic Drug Development
(AFDD) Summit regarding Galectin’s discovery program of its next
generation of oral galectin-3 inhibitors. The presentation
entitled “Therapeutic Integrin Inhibition,” discussed the next
generation of galectin-3 inhibitors, as well as the discovery of
functional allosteric inhibitors.
Financial Results
For the year ended December 31, 2019, the
Company reported a net loss applicable to common stockholders of
$13.6 million, or ($0.26) per share, compared to a net loss
applicable to common stockholders of $15.0 million, or ($0.38) per
share for the full year 2018. The decrease is largely due a
decrease in general and administrative expenses, primarily
stock-based compensation, and preferred stock dividends, somewhat
offset by an increase in research and development expense. Research
and development expense for 2019 was $7.5 million compared with
$6.5 million for 2018. 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,
somewhat offset by lower non-cash stock compensation expenses.
General and administrative expenses for 2019 were $6.0 million,
down from $7.1 million for the full year 2018, primarily due to a
decrease in non-cash stock-based compensation expenses. As
of December 31, 2019, the Company had $47.5
million of cash and cash equivalents. During 2019, the company
effected a Rights Offering which, together with other common stock
and warrants issued, raised $50.5 million in net proceeds. 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 efficacy 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 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 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
|
Year Ended December
31, |
|
2019 |
2018 |
|
Operating expenses: |
|
|
Research and development |
$ |
7,467 |
$ |
6,471 |
General and administrative |
5,971 |
7,131 |
Total operating expenses |
13,438 |
13,602 |
Total operating loss |
(13,438) |
(13,602) |
Other income (expense): |
|
|
Interest income |
231 |
38 |
Interest expense |
(87) |
(336) |
Total other income |
144 |
(298) |
Net loss |
$ |
(13,294) |
$ |
(13,900) |
Preferred stock dividends |
(263) |
(1,147) |
Warrant modification |
(6,622) |
- |
Net loss applicable to common stock |
$ |
(20,179) |
$ |
(15,047) |
Basic and diluted net loss per share |
$ |
(0.39) |
$ |
(0.38) |
Shares used in computing basic and diluted net loss per share |
52,238 |
39,414 |
Condensed Consolidated Balance Sheet
Data
|
|
December 31, 2019 |
|
December 31, 2018 |
|
|
(in thousands) |
Cash and cash equivalents |
$ |
47,480 |
$ |
8,253 |
Total assets |
|
48,467 |
|
9,006 |
Total current liabilities |
|
2,820 |
|
2,108 |
Total liabilities |
|
2,872 |
|
2,108 |
Total redeemable, convertible preferred stock |
|
1,723 |
|
1,723 |
Total stockholders’ equity |
$ |
43,872 |
$ |
5,175 |
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