RAANANA, Israel, June 1, 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 three months ended
March 31, 2016 and provided an update
on the development program for its lead drug candidate hCDR1 in the
treatment of Systemic Lupus Erythematosus (SLE).
"We achieved numerous milestones in the first quarter including
key clinical events that move hCDR1 towards an upcoming Phase 2
trial designed to have a high likelihood of success based on prior
clinical study findings. We strengthened our intellectual property
portfolio, advanced chemistry, manufacturing and controls for
hCDR1, and added a world renowned thought leader as our Medical
Director," said Josh Levine, CEO of
XTL.
Clinical and Operational Update
- Received Encouraging Feedback from U.S. FDA
In January, XTL announced it 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.
- Received European Medicines Agency's SME Status
In February, XTL announced it 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.
- Completed Production of Representative Batches of hCDR1
In February, XTL completed production of representative batches of
drug product with BioConnection NV to advance its chemistry,
manufacturing and controls (CMC) program for the planned Phase 2
trial of hCDR1.
- Granted Patent in Israel
In February, XTL announced hCDR1 was granted a patent in
Israel titled, "Pharmaceutical
Compositions Comprising a Peptide and a Substituted ß Cyclodextrin
for use in Treating Systemic Lupus Erythematosus and Processes for
their Manufacture," which addresses the pharmaceutical composition
and manufacturing processes of hCDR1.
- Completed Phase 2 Trial Design
In March, XTL announced completion of 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.
- Granted Patent in Hungary
In March, XTL announced the Hungarian Intellectual Property Office
granted a patent for hCDR1 in the treatment of lupus titled
"Synthetic Human Peptides and Pharmaceutical Compositions
Comprising Them for the Treatment of Systemic Lupus
Erythematosus."
- Appointed Medical Director
In March, XTL appointed Dr. Daphna
Paran, a world renowned expert in the treatment of lupus and
an internal medicine and rheumatology specialist, as Medical
Director.
Financial Overview
XTL reported $3.1 million in cash,
cash equivalents and bank deposits as of March 31, 2016. Funds will be used to advance the
hCDR1 clinical program for the treatment of SLE.
Research and development expenses for the quarter ended
March 31, 2016 were $233,000 compared with $42,000 for the same period in 2015, reflecting
the Company's increased investment in the hCDR1 clinical program
and preparations for a Phase 2 clinical trial. First quarter
development activities included the completion of the trial design
for the planned Phase 2 trial of hCDR1 for the treatment of SLE and
production of the drug product for that trial.
General and administrative expenses for the three months ended
March 31, 2016 were $369,000 compared with $334,000 for the same period in 2015.
XTL reported an operating loss for the quarter ended
March 31, 2016 of $602,000 compared with $376,000 for the same period in 2015 reflecting
increased spending on research and development. The Company
reported a total net loss for the period ended March 31, 2016 of approximately $600,000 or $0.002
per share, compared to $1.1 million
or $0.005 per share in the same
period in 2015. Total net loss in the first quarter of 2015
included a loss from discontinued operations of approximately
$689,000.
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands)
|
Consolidated
Statements of Financial Position - Selected Data
|
|
|
As
of
|
|
|
March
31,
|
|
|
2016
|
|
2015
|
Cash, Cash
Equivalents and bank deposits
|
|
$
3,109
|
|
$
1,753
|
Other current
assets
|
|
527
|
|
636
|
Non-current
assets
|
|
1,122
|
|
2,624
|
Total
assets
|
|
4,758
|
|
5,013
|
|
|
|
|
|
Total
liabilities
|
|
$
372
|
|
$
376
|
Total shareholders'
equity
|
|
4,386
|
|
4,637
|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
(USD in
thousands, except per share amounts)
|
Consolidated
Statements of Comprehensive Income - Selected
Data
|
|
For the three
months ended
|
March
31,
|
|
2016
|
|
2015
|
Research and
Development expenses
|
(233)
|
|
(42)
|
General and
administrative expenses
|
(369)
|
|
(334)
|
Operating
Loss
|
$
(602)
|
|
$
(376)
|
Finance
income
|
$
27
|
|
$
5
|
Finance
expenses
|
(2)
|
|
(16)
|
Finance income
(expenses), net
|
$
25
|
|
$
(11)
|
Total loss from
continuing operations
|
$
(577)
|
|
$
(387)
|
|
|
|
|
Total loss from
discontinued operations
|
$
-
|
|
$
(689)
|
Total loss for the
period
|
$
(577)
|
|
$
(1,076)
|
|
|
|
|
Other
comprehensive income (loss):
|
|
|
|
Revaluation of AFS
financial assets
|
$
27
|
|
$
-
|
Total
comprehensive loss for the period
|
$
(550)
|
|
$
(1,076)
|
|
|
|
|
Total loss for the
period attributable to:
|
|
|
|
Equity holders of the
Company
|
$
(577)
|
|
$
(1,078)
|
Non-controlling
interests
|
-
|
|
2
|
|
$
(577)
|
|
$
(1,076)
|
|
|
|
|
Total
comprehensive loss for the period attributable to:
|
|
|
|
Equity holders of the
Company
|
$
(550)
|
|
$
(1,078)
|
Non-controlling
interests
|
-
|
|
2
|
|
$
(550)
|
|
$
(1,076)
|
|
|
|
|
Basic and diluted
loss per share from continuing and discontinued operations (in U.S.
dollars):
|
|
|
|
From continuing
operations
|
(0.002)
|
|
(0.003)
|
From discontinued
operations
|
-
|
|
(0.002)
|
Total basic and
diluted loss per share (in U.S. dollars)
|
$
(0.002)
|
|
$
(0.005)
|
Weighted average
number of issued ordinary shares
|
273,646,688
|
|
233,561,229
|
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. Robust clinical
data on hCDR1 has been produced 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.
For further information, please contact:
Investor
Relations, XTL Biopharmaceuticals Ltd.
Tel: +972 9 955
7080
Email: ir@xtlbio.com
www.xtlbio.com
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 prices 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, except as may be required
under applicable law. 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.
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SOURCE XTL Biopharmaceuticals Ltd