RAANANA, Israel, Dec. 6, 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 autoimmune
diseases including lupus, today reported financial results for the
three and nine months ended September 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).
"During the first nine months 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 three patents granted
for hCDR1 and the filing of two new patent applications in the US
since the beginning of the year. We are also investigating
hCDR1's potential use in other autoimmune indications."
Clinical and Operational Update:
- Prepared to Commence Phase 2 Trial
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. Food and Drug
Administration (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 earlier in 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
During the third quarter, hCDR1 was 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. Patents were also issued for hCDR1 in
Hungary and Israel earlier this year. In a move to further
broaden hCDR1's intellectual property rights, two new patent
applications were filed with the U.S. Patent and Trademark Office
to protect doses of hCDR1 at and below 0.5 mg weekly in the
treatment of SLE.
Financial Overview
XTL reported $2.3 million in cash
and cash equivalents as of September 30,
2016. Funds will be used to advance the hCDR1 clinical
program for the treatment of SLE, to investigate its use in other
indications and to identify additional assets for the treatment of
other autoimmune diseases.
Research and development expenses for the quarter ended
September 30, 2016 were $35,000 compared with $134,000 for the same period in 2015. For the
nine months ended September 30, 2016
research and development expenses were $390,000 compared with $245,000 for the same period in 2015. The year to
date increase reflects the Company's increased investment in the
hCDR1 clinical program and preparations for a Phase 2 clinical
trial. Development activities include the completion of the
trial design for the planned Phase 2 trial of hCDR1 for the
treatment of SLE, production of the drug product for that trial and
investigation of the use of hCDR1 in other autoimmune indications.
Initiation of the Phase 2 clinical trial in SLE will require the
Company to raise additional capital.
General and administrative expenses for the three months ended
September 30, 2016 were $265,000, in line with the expenditure for the
same period in 2015. For the nine months ended September 30, 2016 general and administrative
expenses were $978,000 compared to
$1,008,000 in the first nine months
of 2015.
XTL reported an operating loss for the quarter ended
September 30, 2016 of $300,000 compared with $396,000 for the same period in 2015. For the
nine-month period ended September 30,
2016 XTL reported an operating loss of $1,368,000 as compared to $1,253,000 in the first nine months of the prior
year.
The Company reported a total comprehensive loss for the quarter
ended September 30, 2016 of
$279,000, or $0.001 per share, compared to $443,000 or $0.002
per share, in the same period in 2015. For the nine months ended
September 30, 2016 XTL reported a
total net loss of $1,222,000 or
$0.005 per share, compared to
$1,946,000 or $0.008 per share, in the first nine months of
2015. Total net loss in the first nine months of 2015 included a
loss from discontinued operations of $460,000, or $0.002
per share.
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands)
|
Consolidated
Statements of Financial Position - Selected Data
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
2015
|
|
|
|
|
|
|
|
Cash, Cash
Equivalents and bank deposits
|
|
$
2,322
|
|
$
4,300
|
|
$
3,817
|
Other current
assets
|
|
612
|
|
487
|
|
448
|
Non-current
assets
|
|
1,122
|
|
2,698
|
|
1,058
|
Total
assets
|
|
4,056
|
|
7,485
|
|
5,323
|
|
|
|
|
|
|
|
Total
liabilities
|
|
$
231
|
|
$
262
|
|
$
436
|
Total shareholders'
equity
|
|
3,825
|
|
7,223
|
|
4,887
|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
|
(USD in
thousands, except per share amounts)
|
|
Consolidated
Statements of Comprehensive Loss
|
|
|
|
|
|
Nine months
ended
September
30,
|
|
Three months
ended
September
30,
|
|
Year
ended
December
31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
2015
|
|
|
Unaudited
|
|
|
Audited
|
Research and
development expenses
|
|
(390)
|
|
(245)
|
|
(35)
|
|
(134)
|
|
(578)
|
General and
administrative expenses
|
|
(978)
|
|
(1,008)
|
|
(265)
|
|
(262)
|
|
(1,419)
|
Impairment of
intangible asset
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(1,604)
|
Other loss
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(10)
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
$
(1,368)
|
|
$
(1,253)
|
|
$
(300)
|
|
$
(396)
|
|
$
(3,611)
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income
|
|
34
|
|
29
|
|
15
|
|
10
|
|
4
|
Finance
expenses
|
|
(6)
|
|
(262)
|
|
(1)
|
|
(57)
|
|
(15)
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
(expenses), net
|
|
$
28
|
|
$
(233)
|
|
$
14
|
|
$
(47)
|
|
$
(11)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing
operations
|
|
$
(1,340)
|
|
$
(1,486)
|
|
$
(286)
|
|
$
(443)
|
|
$
(3,622)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
discontinued operations
|
|
$
-
|
|
$
(460)
|
|
$
-
|
|
$
-
|
|
$
(689)
|
|
|
|
|
|
|
|
|
|
|
|
Total loss for the
period
|
|
$
(1,340)
|
|
$
(1,946)
|
|
$
(286)
|
|
$
(443)
|
|
$
(4,311)
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
Revaluation of AFS
financial assets
|
|
118
|
|
-
|
|
7
|
|
-
|
|
-
|
Total
comprehensive loss for the period
|
|
$
(1,222)
|
|
$
(1,946)
|
|
$
(279)
|
|
$
(443)
|
|
$
(4,311)
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period
attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
(1,340)
|
|
(1,948)
|
|
(286)
|
|
(443)
|
|
(4,313)
|
Non-controlling
interests
|
|
-
|
|
2
|
|
-
|
|
-
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
(1,340)
|
|
$
(1,946)
|
|
$
(286)
|
|
$
(443)
|
|
$
(4,311)
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
for the period attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
(1,222)
|
|
(1,948)
|
|
(279)
|
|
(443)
|
|
(4,313)
|
Non-controlling
interests
|
|
-
|
|
2
|
|
-
|
|
-
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
(1,222)
|
|
$
(1,946)
|
|
$
(279)
|
|
$
(443)
|
|
$
(4,311)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share from continuing and
discontinued operations (in U.S. dollars):
|
|
|
|
|
|
|
|
|
|
|
From continuing
operations
|
|
(0.005)
|
|
(0.006)
|
|
(0.001)
|
|
(0.002)
|
|
(0.014)
|
From discontinued
operations
|
|
-
|
|
(0.002)
|
|
-
|
|
-
|
|
(0.003)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share for
the period
|
|
$
(0.005)
|
|
$
(0.008)
|
|
$
(0.001)
|
|
$
(0.002)
|
|
$
(0.017)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
three 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.
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 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 F-1/A filed with the U.S.
Securities and Exchange Commission on November 8, 2016.
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SOURCE XTL Biopharmaceuticals Ltd