RAANANA, Israel, Sept. 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,
today provided its financial and operational results for the second
quarter and the six months ended June 30,
2015.
Josh Levine, Chief Executive
Officer of XTL, commented, "During the second quarter, we made
significant progress towards developing our clinical asset for
lupus/SLE and preparing it for a planned clinical trial. In
April 2015, we closed a US$4 million registered direct offering with a
US-based healthcare-dedicated investor and with existing
shareholders, which we believe will allow us to progress towards
the commencement of advanced clinical trials for our lead drug
candidate, hCDR1, a peptide for the treatment of lupus, a
significant unmet clinical need with no effective available
solution. Recently, we added Monique Ben
Am, MSc, to our team to lead our clinical development
efforts. Ms. Ben Am has significant clinical development experience
at large pharmaceutical companies like Novartis, where she was
involved with the development of Gleevec™, and Teva
Pharmaceuticals, Ltd. and several smaller drug development
companies."
"We are pleased with the recent publication of a peer reviewed
article in the Lupus Science and Medicine journal (full article)
authored by world leading rheumatologists and members of our
Clinical Advisory Board, which analyzed the results of a Phase 2b
trial on hCDR1 (the PRELUDE trial), showing favorable safety and
efficacy data on over 300 patients. In addition, the recently
announced news from UCB regarding their drug candidate,
epratuzumab, not meeting its primary endpoints in two Phase 3
studies, further emphasizes the unmet need for patients suffering
from lupus. With few, if any, significant Phase 3 studies ongoing
in this space, we believe there is a substantial opportunity for
our lead drug candidate, hCDR1."
Financial Overview
Following XTL's registered direct offering in April, 2015, XTL
had US$4.8 million in cash and cash
equivalents as of June 30, 2015.
Research and development expenses for the three months ended
June 30, 2015 were US$69,000 compared to US$34,000 in the same period in 2014. Research
and development expenses for the three months ended
June 30, 2015 were comprised mainly
of expenses related to preparations for initiating the clinical
trial of XTL's drug candidate: hCDR1. The increase in expenses in
2015 compared to 2014 for this period is mainly due to the
Company's focus on preparing for the upcoming clinical trial
including the completion of production of the drug substance for
hCDR1.
General and administrative expenses for the three months ended
June 30, 2015 were US$0.4 million in line with general and
administrative expenses for the same period in 2014.
Financial income, net for the three months ended June 30, 2015 was US$54,000 compared to US$20,000 in the three months ended June 30, 2014. The increase in financial income,
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
June 30, 2015 was US$0.4 million compared to US$0.4 million in the same period last year.
Total loss for the three months ended June 30, 2015 was US$0.4
million compared to US$0.7
million in the same period last year. The decrease in loss
was due to losses in 2014 from discontinued operations related to
InterCure, a former subsidiary.
Research and development expenses for the six months ended
June 30, 2015 were US$111,000 compared to US$81,000 for the same period in 2014. Research
and development expenses for the six months ended June 30, 2015 were comprised mainly of expenses
related to preparations for initiating a clinical trial of XTL's
drug candidate: hCDR1. The increase in expenses in 2015 compared to
2014 for this period is mainly due to XTL's focus on preparing its
asset for the upcoming clinical trial including the completion of
production of the drug substance for hCDR1.
General and administrative expenses for the six months ended
June 30, 2015 were US$0.7 million compared with US$0.9 million for the same period in 2014. The
decrease in general and administrative expenses was due to lower
salary and share-based compensation costs in the six months ended
June 30, 2015.
Financial expense, net for the six months ended June 30, 2015 was US$186,000 compared to financial income, net of
US$17,000 for the six months ended
June 30, 2014. The decrease in
financial income, net, was mainly due to losses incurred from the
disposal of XTL's investment in InterCure, a former subsidiary.
Loss from continuing operations for the six months ended
June 30, 2015 was US$1.0 million, in line with loss from continuing
operations for the same period last year.
Total loss for the six months ended June
30, 2015 was US$1.5 million,
in line with total loss in the same period last year. The loss from
discontinued operations for the six months ended June 30, 2015 and 2014 relates to losses from
XTL's investment in InterCure, a former subsidiary.
XTL's consolidated financial results for the six months ended
June 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
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
2014
|
|
|
|
|
|
|
|
Cash, Cash
Equivalents and bank deposits
|
|
$
4,820
|
|
$
2,676
|
|
$
2,159
|
Working
Capital
|
|
5,026
|
|
3,076
|
|
2,102
|
Total
assets
|
|
7,861
|
|
7,224
|
|
5,644
|
|
|
|
|
|
|
|
Long term
liabilities
|
|
$
-
|
|
$
27
|
|
$
-
|
Total shareholders'
equity
|
|
7,630
|
|
5,708
|
|
4,660
|
Non-controlling
interests
|
|
-
|
|
141
|
|
19
|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(USD in
thousands, except per share amounts)
|
Consolidated
Statements of Comprehensive Loss
|
|
|
|
Six months
ended
June
30,
|
|
Three months
ended
June
30,
|
|
Year
ended
December
31,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
2014
|
|
|
Unaudited
|
|
Audited
|
Research and
development expenses
|
|
(111)
|
|
(81)
|
|
(69)
|
|
(34)
|
|
(278)
|
General and
administrative expenses
|
|
(746)
|
|
(916)
|
|
(412)
|
|
(369)
|
|
(1,744)
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
$ (857)
|
|
$ (997)
|
|
$ (481)
|
|
$ (403)
|
|
$
(2,022)
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income
|
|
19
|
|
22
|
|
14
|
|
20
|
|
41
|
Finance
expenses
|
|
(205)
|
|
(5)
|
|
40
|
|
-
|
|
(138)
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
(expenses), net
|
|
$ (186)
|
|
$
17
|
|
$
54
|
|
$
20
|
|
$
(97)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing
operations
|
|
$ (1,043)
|
|
$ (980)
|
|
$ (427)
|
|
$ (383)
|
|
$
(2,119)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
discontinued operations
|
|
$ (460)
|
|
$ (491)
|
|
$
-
|
|
$ (327)
|
|
$
(746)
|
|
|
|
|
|
|
|
|
|
|
|
Total loss for the
period
|
|
$ (1,503)
|
|
$ (1,471)
|
|
$ (427)
|
|
$ (710)
|
|
$
(2,865)
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period
attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
(1,505)
|
|
(1,249)
|
|
(427)
|
|
(563)
|
|
(2,527)
|
Non-controlling
interests
|
|
2
|
|
(222)
|
|
-
|
|
(147)
|
|
(338)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ (1,503)
|
|
$ (1,471)
|
|
$ (427)
|
|
$ (710)
|
|
$
(2,865)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share from continuing and
discontinued operations (in U.S. dollars):
|
|
|
|
|
|
|
|
|
|
|
From continuing
operations
|
|
(0.004)
|
|
(0.004)
|
|
(0.001)
|
|
(0.001)
|
|
(0.009)
|
From discontinued
operations
|
|
(0.002)
|
|
(0.001)
|
|
-
|
|
(0.001)
|
|
(0.002)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share for
the period
|
|
$ (0.006)
|
|
$ (0.005)
|
|
$ (0.001)
|
|
$ (0.002)
|
|
$
(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.
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
Arrowhead Business and Investment Decisions, LLC
140
Broadway, 46th Floor, New York, NY
10005
Daniel Renaud or Thomas Renaud
+1 212 619 6889
enquire@arrowheadbid.com
www.abid.co/NASDAQ.XTLB
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-second-quarter-2015-results-300135872.html
SOURCE XTL Biopharmaceuticals Ltd.