RAANANA, Israel, Dec. 1, 2015 /PRNewswire/ -- XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL) ("XTL" or the
"Company"), a clinical-stage biopharmaceutical company focused on
the acquisition, development and commercialization of
pharmaceutical products for the treatment of unmet clinical needs,
particularly for autoimmune diseases, today provided its financial
and operational results for the third quarter and the nine months
ended September 30, 2015.
Josh Levine, Chief Executive
Officer of XTL, commented, "During the third quarter we continued
to make significant strides in developing our clinical asset, hCDR1
for the treatment of lupus (SLE) and preparing it for advanced
clinical trials."
"Following the publication in August by the Lupus Science and
Medicine journal of a peer reviewed article
(http://lupus.bmj.com/content/2/1/e000104.full) analyzing the
results of a Phase 2b trial on our lupus drug (PRELUDE trial)
showing favorable safety and efficacy data on over 300 patients,
the Company convened a meeting of its Clinical Advisory Board in
September at which the Company finalized a draft protocol for its
planned clinical trial. In November, the Company submitted a
request to the FDA for a pre-IND meeting and expects a written
response to its pre-meeting package in early 2016. Also in
November, the Company contracted with BioConnection
(www.bioconnection.eu) for the production of drug product for the
upcoming clinical trial expected to commence in the middle of 2016.
With few Phase 3 studies ongoing in this space and with hCDR1's
unique mechanism of action, we believe there remains a substantial
opportunity for the Company's lead drug candidate."
Financial Overview
The Company reported US$4.3
million in cash and cash equivalents as of September 30, 2015.
Research and development expenses for the three months ended
September 30, 2015 were US$134,000 compared to US$40,000 for the same period in 2014. Research
and development expenses for the three months ended September 30, 2015 were comprised mainly of
expenses related to preparations for initiating an advanced
clinical trial of the Company's clinical asset, hCDR1. The increase
in research and development expenses reflects the Company's
increased investment in bringing hCDR1 to an advanced clinical
trial in the middle of 2016.
General and administrative expenses for the three months ended
September 30, 2015 were US$262,000 compared to US$327,000 for the same period in 2014.
Financial expenses, net for the three months ended September 30, 2015 were US$47,000 compared to US$72,000 in the three months ended September 30, 2014. The decrease in financial
expenses, net, was mainly due to changes in fair value of
marketable securities held in InterCure, a former subsidiary.
Loss from continuing operations for the three months ended
September 30, 2015 was US$443,000, compared to US$439,000 in the same period last year.
Total loss for the quarter ended September 30, 2015 was $443,000 compared to $568,000 during the same period in 2014. The
decrease in loss was primarily attributable to an increase in
research and development expenses offset by losses in 2014 from
discontinued operations related to InterCure, a former
subsidiary.
Research and development expenses for the nine months ended
September 30, 2015 were US$245,000 compared to US$121,000 for the same period in 2014. Research
and development expenses for the nine months ended September 30, 2015 were comprised mainly of
expenses related to preparations for initiating an advanced
clinical trial of the Company's clinical asset, hCDR1. The increase
in research and development expenses reflects the Company's
increased investment in bringing hCDR1 to an advanced clinical
trial in the middle of 2016.
General and administrative expenses for the nine months ended
September 30, 2015 were US$1,008,000 compared to US$1,243,000 for the same period in 2014. The
decrease in general and administrative expenses was due to lower
rent and maintenance costs, reflecting the Company's continued
efforts to reduce overhead costs, as well as a reduction in salary
and share based compensation costs in the nine months ended
September 30, 2015.
Financial expenses, net for the nine months ended September 30, 2015 were US$233,000 compared to US$55,000 in the nine months ended September 30, 2014. The increase in financial
expenses, net, was mainly due to changes in fair value of
marketable securities held in InterCure, a former subsidiary.
Loss from continuing operations for the nine months ended
September 30, 2015 was US$1,486,000, compared to US$1,419,000 for the same period last year.
Total loss for the nine months ended September 30, 2015 was US$1,946,000 compared to US$2,039,000 for the same period last year. The
loss from discontinued operations for the nine months ended
September 30, 2015
and 2014 relates to losses from XTL's
investment in InterCure, a former subsidiary.
XTL's consolidated financial results for the nine months ended
September 30, 2015 are presented in
accordance with International Financial Reporting Standards.
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands)
|
Consolidated
Statements of Financial Position - Selected Data
|
|
|
As
of
|
|
|
September
30,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
2014
|
|
|
|
|
|
|
|
Cash, Cash
Equivalents and bank deposits
|
|
$
4,300
|
|
$
2,905
|
|
$
2,159
|
Other current
assets
|
|
518
|
|
994
|
|
963
|
Non-current
assets
|
|
2,667
|
|
2,789
|
|
2,522
|
Total
assets
|
|
7,485
|
|
6,688
|
|
5,644
|
|
|
|
|
|
|
|
Total
liabilities
|
|
$
262
|
|
$
1,211
|
|
$
965
|
Total shareholders'
equity
|
|
7,223
|
|
5,393
|
|
4,660
|
Non-controlling
interests
|
|
-
|
|
84
|
|
19
|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands, except per share amounts)
|
Consolidated
Statements of Comprehensive Income
|
|
|
|
Nine months
ended
September
30,
|
|
Three months
ended
September
30,
|
|
Year
ended
December
31,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
2014
|
|
|
Unaudited
|
|
Audited
|
Research and
development expenses
|
|
(245)
|
|
(121)
|
|
(134)
|
|
(40)
|
|
(278)
|
General and
administrative expenses
|
|
(1,008)
|
|
(1,243)
|
|
(262)
|
|
(327)
|
|
(1,744)
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
$ (1,253)
|
|
$ (1,364)
|
|
$ (396)
|
|
$ (367)
|
|
$
(2,022)
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income
|
|
29
|
|
15
|
|
10
|
|
(7)
|
|
41
|
Finance
expenses
|
|
(262)
|
|
(70)
|
|
(57)
|
|
(65)
|
|
(138)
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
(expenses), net
|
|
$ (233)
|
|
$ (55)
|
|
$ (47)
|
|
$ (72)
|
|
$
(97)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing
operations
|
|
$ (1,486)
|
|
$ (1,419)
|
|
$ (443)
|
|
$ (439)
|
|
$
(2,119)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
discontinued operations
|
|
$ (460)
|
|
$ (620)
|
|
$
-
|
|
$ (129)
|
|
$
(746)
|
|
|
|
|
|
|
|
|
|
|
|
Total loss for the
period
|
|
$ (1,946)
|
|
$ (2,039)
|
|
$ (443)
|
|
$ (568)
|
|
$
(2,865)
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period
attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
(1,948)
|
|
(1,759)
|
|
(443)
|
|
(510)
|
|
(2,527)
|
Non-controlling
interests
|
|
2
|
|
(280)
|
|
-
|
|
(58)
|
|
(338)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ (1,946)
|
|
$ (2,039)
|
|
$ (443)
|
|
$ (568)
|
|
$
(2,865)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share from continuing and discontinued operations
(in U.S. dollars):
|
|
|
|
|
|
|
|
|
|
|
From continuing
operations
|
|
(0.006)
|
|
(0.005)
|
|
(0.002)
|
|
(0.001)
|
|
(0.009)
|
From discontinued
operations
|
|
(0.002)
|
|
(0.003)
|
|
-
|
|
(0.002)
|
|
(0.002)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share for
the period
|
|
$ (0.008)
|
|
$ (0.008)
|
|
$ (0.002)
|
|
$ (0.003)
|
|
$
(0.011)
|
About XTL Biopharmaceuticals Ltd. ("XTL")
XTL Biopharmaceuticals Ltd., a biopharmaceutical company,
focuses on the acquisition, development, and commercialization of
pharmaceutical products for the treatment of unmet clinical needs.
Currently, XTL is focused on late stage clinical development of its
drug for the treatment of lupus.
XTL is a public company, traded on the Nasdaq Capital Market
(NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTL). 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 Annual Report on Form 20-F as
filed with the U.S. Securities and Exchange Commission on
April 28 2015.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/xtl-biopharmaceuticals-reports-third-quarter-2015-results-and-confirms-intention-to-start-lupus-trial-in-2016-300185973.html
SOURCE XTL Biopharmaceuticals Ltd.