RAANANA, Israel, Sept. 27, 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 reported financial results for the three and six months ended
June 30, 2016, as well as a clinical
and operational update on the development program for its lead drug
candidate hCDR1 in the treatment of Systemic Lupus Erythematosus
(SLE).
"In the first half of 2016 we achieved important milestones
towards commencing our Phase 2 hCDR1 study, which we believe is
designed to reveal strong efficacy results for our drug in the
treatment of SLE. The trial design is based on very encouraging
feedback from the U.S. FDA regarding BILAG as the efficacy endpoint
and 0.5 mg as the weekly dosage of hCDR1. These are parameters that
produced successful results in a prior trial," stated Josh Levine, CEO of XTL. "We continue to build
our hCDR1 IP portfolio with the filing of two patent applications
in the US, as well as working on chemistry, manufacturing and
controls for Phase 2, future trials, and future commercial
production."
Clinical and Operational Update:
- Prepared to Commence Phase 2 Trial
During the first half of 2016, XTL completed the clinical trial
design of its Phase 2 study of hCDR1 in the treatment of SLE. The
protocol was designed in consultation with its world renowned
Clinical Advisory Board and based on encouraging feedback from a
pre-investigational new drug (IND) meeting package submission to
the U.S. FDA. The trial design includes a treatment arm dosing
weekly at 0.5 mg hCDR1 and BILAG, a measure of lupus disease
activity, 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 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.
- Production Batches of hCDR1 Ready for Phase 2 Trial
XTL completed production of representative batches of hCDR1, with
BioConnection NV during the first half of 2016. These manufactured
batches advance XTL's chemistry, manufacturing and controls (CMC)
program for the planned Phase 2 trial of hCDR1.
- Strengthened Intellectual Property Portfolio
hCDR1 was recently granted an important patent in Europe titled "Parenteral Formulations of
Peptides for the Treatment of Systemic Lupus Erythematosus," which
addresses non-oral drug formulations of hCDR1 in the treatment of
SLE. In a move to further broaden hCDR1's intellectual property
rights, XTL filed two new patent applications with the U.S.
Patent and Trademark Office to protect doses of hCDR1 lower than
0.5 mg weekly in the treatment of SLE.
Financial Overview
XTL reported $2.6 million in cash
and cash equivalents as of June 30,
2016. Funds will be used to advance the hCDR1 clinical
program for the treatment of SLE.
Research and development expenses for the quarter ended
June 30, 2016 were $122,000 compared with $69,000 for the same period in 2015. For the six
months ended June 30, 2016 research
and development expenses were $355,000 compared with $111,000 for the same period in 2015. The three
and six-month period increases reflect the Company's increased
investment in the hCDR1 clinical program and preparations for a
Phase 2 clinical trial. First and second 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. The initiation of
the clinical trial will require the Company to raise additional
capital.
General and administrative expenses for the three months ended
June 30, 2016 were $344,000 compared with $412,000 for the same period in 2015. For the six
months ended June 30, 2016 general
and administrative expenses were $713,000 compared to $746,000 in the first half of 2015.
XTL reported an operating loss for the quarter ended
June 30, 2016 of $466,000 compared with $481,000 for the same period in 2015. For the
six-month period ended June 30, 2016
XTL reported an operating loss of $1,068,000 as compared to $857,000 in the first half of the prior year.
The Company reported a total comprehensive loss for the quarter
ended June 30, 2016 of $393,000 or $0.002
per share, compared to $427,000 or
$0.001 per share in the same period
in 2015. For the six months ended June 30,
2016 XTL reported a total net loss of $943,000 or $0.004
per share, compared to $1,503,000 or
$0.006 per share in the first half of
2015. Total net loss in the first six months of 2015 included a
loss from discontinued operations of $689,000, or $0.002
per share.
|
|
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|
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XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands)
|
Consolidated
Statements of Financial Position - Selected Data
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
2016
|
|
2015
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
Cash, Cash
Equivalents and bank deposits
|
$
|
2,605
|
|
$
|
4,820
|
|
$
|
3,817
|
Other current
assets
|
|
612
|
|
|
405
|
|
|
448
|
Non-current
assets
|
|
1,120
|
|
|
2,636
|
|
|
1,058
|
Total
assets
|
|
4,337
|
|
|
7,861
|
|
|
5,323
|
|
|
|
|
|
|
|
|
|
Total
liabilities
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$
|
258
|
|
$
|
231
|
|
$
|
436
|
Total shareholders'
equity
|
|
4,079
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|
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7,630
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4,887
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|
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|
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|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
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|
(USD in
thousands, except per share amounts)
|
|
Consolidated
Statements of Comprehensive Loss
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|
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|
|
Six months
ended
|
|
Three months
ended
|
|
Year
ended
|
June
30,
|
June
30,
|
December
31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
2015
|
|
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Unaudited
|
|
|
Audited
|
Research and
development expenses
|
|
-355
|
|
-111
|
|
-122
|
|
-69
|
|
-578
|
General and
administrative expenses
|
|
-713
|
|
-746
|
|
-344
|
|
-412
|
|
-1,419
|
Impairment of
intangible asset
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-1,604
|
Other loss
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-10
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
$
(1,068)
|
|
$
(857)
|
|
$
(466)
|
|
$
(481)
|
|
$
(3,611)
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income
|
|
19
|
|
19
|
|
-
|
|
14
|
|
4
|
Finance
expenses
|
|
-5
|
|
-205
|
|
11
|
|
40
|
|
-15
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
(expenses), net
|
|
$
14
|
|
$
(186)
|
|
$
(11)
|
|
$
54
|
|
$
(11)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing
operations
|
|
$
(1,054)
|
|
$
(1,043)
|
|
$
(477)
|
|
$
(427)
|
|
$
(3,622)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
discontinued operations
|
|
$
-
|
|
$
(460)
|
|
$
-
|
|
$
-
|
|
$
(689)
|
|
|
|
|
|
|
|
|
|
|
|
Total loss for the
period
|
|
$
(1,054)
|
|
$
(1,503)
|
|
$
(477)
|
|
$
(427)
|
|
$
(4,311)
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
Revaluation of AFS
financial assets
|
|
111
|
|
-
|
|
84
|
|
-
|
|
-
|
Total
comprehensive loss for the period
|
|
$
(943)
|
|
$
(1,503)
|
|
$
(393)
|
|
$
(427)
|
|
$
(4,311)
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period
attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
-1,054
|
|
-1,505
|
|
-477
|
|
-427
|
|
-4,313
|
Non-controlling
interests
|
|
-
|
|
2
|
|
-
|
|
-
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
(1,054)
|
|
$
(1,503)
|
|
$
(477)
|
|
$
(427)
|
|
$
(4,311)
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
for the period attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
-943
|
|
-1,505
|
|
-393
|
|
-427
|
|
-4,313
|
Non-controlling
interests
|
|
-
|
|
2
|
|
-
|
|
-
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
(943)
|
|
$
(1,503)
|
|
$
(393)
|
|
$
(427)
|
|
$
(4,311)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share from continuing and
|
|
|
|
|
|
|
|
|
|
|
discontinued
operations (in U.S. dollars):
|
From continuing
operations
|
|
-0.004
|
|
-0.004
|
|
-0.002
|
|
-0.001
|
|
-0.014
|
From discontinued
operations
|
|
-
|
|
-0.002
|
|
-
|
|
-
|
|
-0.003
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share for
the period
|
|
$
(0.004)
|
|
$
(0.006)
|
|
$
(0.002)
|
|
$
(0.001)
|
|
$
(0.017)
|
For more detailed financial information and accompanying notes
please review the Company's unaudited financial statements as of
and for the periods ended June 30,
2016 filed in the Company's current report on Form 6-K on
September 27, 2016.
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 inflammatory 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 dysregulation of 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