RAANANA, Israel, March 31, 2016 /PRNewswire/ -- XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA)
("XTL" or the "Company"), a clinical-stage biopharmaceutical
company developing its lead product for the treatment of lupus,
today announced financial results for the year ended December 31, 2015 and provided an update on the
development program for its lead drug candidate hCDR1.
"2015 was a pivotal year for us, laying the foundation for the
advancement of hCDR1 towards a global Phase 2 trial designed to
have a high likelihood of success based on prior clinical study
findings. We're proud of having assembled a world class team of
lupus experts at XTL. In the year ahead, we intend to execute on
the advancement of hCDR1, which we believe holds tremendous promise
for lupus patients currently in need of an effective treatment,"
said Josh Levine, CEO of XTL.
Clinical and Operational Update
- XTL received very encouraging feedback from the U.S. Food and
Drug Administration (FDA) in response to its pre-investigational
new drug (IND) meeting package for hCDR1. This successful outcome
included BILAG, a measure of lupus disease activity, as the primary
efficacy endpoint. Based on prior positive efficacy data using
BILAG as the measure, XTL believes the FDA's guidance will improve
the likelihood of a successful trial. The FDA's guidance also
included parameters on patient inclusion criteria and patient
population for safety requirements for marketing approval.
- XTL completed the Phase 2 clinical trial design for hCDR1 in
the treatment of SLE, in consultation with its world renowned
Clinical Advisory Board. The trial design includes a treatment arm
dosing weekly at 0.5 mg hCDR1 and BILAG as the measure for the
primary efficacy endpoint. Data from the prior Phase 2 study
clearly showed a statistically significant effect of a 0.5 mg dose
of hCDR1 on the BILAG index.
- XTL joined the Lupus Foundation of America's Corporate Advisory
Council. In 2015 XTL's Scientific Advisor, Dr. Murray Urowitz of the University of Toronto University Health Network,
provided the Lupus Foundation of America with an analysis of data
from the Phase 2 clinical study of hCDR1 in the treatment of
SLE.
- Lupus Science & Medicine Journal published results
from the Phase 2b study on the safety and efficacy of hCDR1 for the
treatment of SLE. The study showed that hCDR1 was safe, well
tolerated, and met the secondary endpoint, BILAG, when treated with
0.5 mg dose of hCDR1.
- hCDR1 was granted a patent for pharmaceutical composition and
manufacturing processes in Israel;
and granted a patent for synthetic human peptides and
pharmaceutical compositions for peptides in the treatment of SLE in
Hungary.
- XTL appointed Dr. Daphna Paran,
a world renowned expert in the treatment of lupus and an internal
medicine and rheumatology specialist, as Medical Director.
- XTL received the European Medicines Agency's Small or
Medium Sized Business Enterprise (SME) status in Europe, offering numerous benefits including
fee reductions for pre and post marketing phases, scientific and
procedural advice, and eligibility for funding and grants.
- XTL advanced its chemistry, manufacturing and controls (CMC)
for hCDR1 through an agreement with CyDex Pharmaceuticals for the
use of and supply of Captisol® and BioConnection for the production
of hCDR1.
Financial Overview
XTL reported $3.8 million in cash,
cash equivalents and bank deposits as of December 31, 2015. Funds will be used to advance
the hCDR1 clinical program for the treatment of SLE.
Research and development expenses for the year ended
December 31, 2015 were $578,000 compared with $278,000 for 2014, reflecting increased
investment in the hCDR1 clinical program and preparations for a
Phase 2 clinical trial. General and administrative expenses for the
year ended December 31, 2015 were
$1.4 million compared with
$1.7 million in 2014, reflecting the
Company's continued efforts to reduce overhead costs and lower
share-based compensation expenses.
XTL reported an operating loss for the year ended December 31, 2015 of $3.6
million compared with $2.0
million for 2014. The 2015 loss includes a $1.6 million impairment in the Company's
intangible asset related to its secondary clinical asset as it
focuses its efforts and resources on the development of its lead
asset, hCDR1 for the treatment of SLE. The Company reported a total
net loss for the year ended December 31,
2015 of $4.3 million or 0.017
per share, compared to $2.9 million
or 0.011 per share in 2014. Total net loss included a loss from
discontinued operations of approximately $689,000 in 2015 and $746,000 in 2014.
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands)
|
Consolidated
Statements of Financial Position - Selected Data
|
|
|
As
of
|
|
|
December
31,
|
|
|
2015
|
|
2014
|
Cash, Cash
Equivalents and bank deposits
|
|
$
3,817
|
|
$
2,159
|
Other current
assets
|
|
448
|
|
963
|
Non-current
assets
|
|
1,058
|
|
2,522
|
Total
assets
|
|
5,323
|
|
5,644
|
|
|
|
|
|
Total
liabilities
|
|
$
436
|
|
$
965
|
Total shareholders'
equity
|
|
4,887
|
|
4,660
|
Non-controlling
interests
|
|
-
|
|
19
|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
(USD in
thousands, except per share amounts)
|
Consolidated
Statements of Comprehensive Income - Selected
Data
|
|
|
|
|
|
|
|
Year
ended
December
31,
|
|
|
2015
|
|
2014
|
|
|
Audited
|
Research and
development expenses
|
|
(578)
|
|
(278)
|
General and
administrative expenses
|
|
(1,419)
|
|
(1,744)
|
Impairment of
intangible assets
|
|
(1,604)
|
|
-
|
Other gains (losses),
net
|
|
(10)
|
|
-
|
|
|
|
|
|
Operating
loss
|
|
$
(3,611)
|
|
$
(2,022)
|
|
|
|
|
|
Finance income
(expenses), net
|
|
$
(11)
|
|
$
(97)
|
|
|
|
|
|
Loss from continuing
operations
|
|
$
(3,622)
|
|
$
(2,119)
|
|
|
|
|
|
Loss from
discontinued operations
|
|
$
(689)
|
|
$
(746)
|
|
|
|
|
|
Total loss for the
period
|
|
$
(4,311)
|
|
$
(2,865)
|
|
|
|
|
|
Loss for the period
attributable to:
|
|
|
|
|
Equity holders of the
Company
|
|
(4,313)
|
|
(2,527)
|
Non-controlling
interests from discontinued operations
|
|
2
|
|
(338)
|
|
|
|
|
|
|
|
$
(4,311)
|
|
$
(2,865)
|
|
|
|
|
|
Basic and diluted
loss per share (in U.S. dollars):
|
|
|
|
|
From continuing
operations
|
|
(0.014)
|
|
(0.009)
|
From discontinued
operations
|
|
(0.003)
|
|
(0.002)
|
|
|
|
|
|
Loss per share for
the period
|
|
$
(0.017)
|
|
$
(0.011)
|
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and
has clinical data on over 400 patients in three clinical
studies. The drug has a favorable safety profile, is well
tolerated by patients and has demonstrated efficacy in at least one
clinically meaningful endpoint. For more information please see a
peer reviewed article in Lupus Science and Medicine journal (full
article).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in
the human body, including joints, kidneys, central nervous system,
heart, hematological system and others. The biologic basis of the
disease is a defect in the immune (defense) system, leading to
production of self (auto) antibodies, attacking the normal organs
and causing irreversible damage. According to the Lupus Foundation
of America, at least 1.5 million Americans have the disease (more
than 5 million worldwide) with more than 16,000 new cases diagnosed
each year. The majority of patients are women of childbearing
years. There has been only one drug approved by the FDA in the last
50 years and recently two of the few drugs in advanced development
did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd. is a clinical-stage biotech
company focused on the development of pharmaceutical products for
the treatment of autoimmune diseases including lupus. The Company's
lead drug candidate, hCDR1, is a world-class clinical asset for the
treatment of systemic lupus erythematosus (SLE). Treatments
currently on the market for SLE are not effective enough for most
patients and some have significant side effects. hCDR1 has robust
clinical data in three clinical trials with 400 patients and over
200 preclinical studies with data published in more than 40
peer reviewed scientific journals.
XTL is traded on the Nasdaq Capital Market (NASDAQ: XTLB)
and the Tel Aviv Stock Exchange (TASE: XTLB.TA). XTL shares are
included in the following indices: Tel-Aviv Biomed, Tel-Aviv
MidCap, and Tel-Aviv Tech Index.
Cautionary Statement
This press release may contain forward-looking statements, about
XTL's expectations, beliefs or intentions regarding, among other
things, its product development efforts, business, financial
condition, results of operations, strategies or prospects. In
addition, from time to time, XTL or its representatives have made
or may make forward-looking statements, orally or in writing.
Forward-looking statements can be identified by the use of
forward-looking words such as "believe," "expect," "intend,"
"plan," "may," "should" or "anticipate" or their negatives or other
variations of these words or other comparable words or by the fact
that these statements do not relate strictly to historical or
current matters. These forward-looking statements may be included
in, but are not limited to, various filings made by XTL with the
U.S. Securities and Exchange Commission, press releases or oral
statements made by or with the approval of one of XTL's authorized
executive officers. Forward-looking statements relate to
anticipated or expected events, activities, trends or results as of
the date they are made. Because forward-looking statements relate
to matters that have not yet occurred, these statements are
inherently subject to risks and uncertainties that could cause
XTL's actual results to differ materially from any future results
expressed or implied by the forward-looking statements. Many
factors could cause XTL's actual activities or results to differ
materially from the activities and results anticipated in such
forward-looking statements, including, but not limited to, the
factors summarized in XTL's filings with the SEC and in its
periodic filings with the TASE. In addition, XTL operates in an
industry sector where securities values are highly volatile and may
be influenced by economic and other factors beyond its control. XTL
does not undertake any obligation to publicly update these
forward-looking statements, whether as a result of new information,
future events or otherwise. Please see the risk factors associated
with an investment in our ADSs or ordinary shares which are
included in our Form 20-F filed with the U.S. Securities and
Exchange Commission on March 31,
2016.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel: +972-9-955-7080
Email: ir@xtlbio.com
www.xtlbio.com
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SOURCE XTL Biopharmaceuticals Ltd