RAANANA, Israel, June 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 announced that following an evaluation of the market
opportunity for it pipeline products, the Company has decided to
focus its efforts and expenditures exclusively on its two core
assets: hCDR1 for the treatment of SLE/lupus and rHuEPO for
"no-option" multiple myeloma patients. XTL also provided its
financial and operational results for the first quarter ended
March 31, 2015.
Focus on Core Assets
Josh Levine, Chief Executive
Officer of XTL, commented, "Following our analysis of the market
opportunity and commercial prospects for our leading clinical
assets, we have decided to focus our resources and efforts
exclusively behind the development of hCDR1 for the treatment of
lupus and rHuEPO for "no-option" multiple myeloma patients and to
withdraw from further progress on a combination therapy for
schizophrenia in-licensed by the Company in 2011.
Lupus is a debilitating autoimmune disease and represents a
large unmet medical need, with only one new treatment approved by
the FDA in the past 50 years. A fourth quarter announcement by Eli
Lilly that it discontinued development of a Phase III asset in this
space further emphasized the unmet need and positions the Company
to garner significant interest in our lupus asset from clinicians,
lupus patients and partners which will no doubt lead to "game
changing" opportunities for us.
rHuEPO has demonstrated a significant survival benefit for a
number of end-stage multiple myeloma patients and results have been
published in medical journals. XTL owns a use patent and has
obtained orphan drug designation for this application of the drug
in the United States."
First Quarter 2015 Financial Overview
XTL reported US$1.8 million in
cash and cash equivalents as of March 31,
2015. The additional funds from the US$4 million fundraise in April 2015, will allow the Company to advance its
hCDR1 program for the treatment of SLE and initiate a clinical
trial on its rHuEPO for multiple myeloma asset.
The Company reported research and development expenses for the
quarter ended March 31, 2015 of
US$42,000 compared with US$47,000 in the first quarter of 2014. General
and administrative expenses for the quarter ended March 31, 2015 remain under tight control with
US$0.3 million in the first quarter
compared with US$0.5 million for the
same period in 2014.
XTL reported an operating loss for the quarter ended
March 31, 2015 of US$0.3 million compared to US$0.6 million for the same period last
year. Finance expenses of US$0.2
million related to its investment in InterCure contributed
to a net loss from continuing operations for the quarter ended
March 31, 2015 of US$0.6 million, in line with results for the same
period last year.
Mr. Levine commented: "Our first quarter financial results are
in line with our expectations and following the recent closing of a
US$4 million registered direct
offering with a US based healthcare dedicated investor and existing
shareholders, we are ready to execute our strategic plan with the
goal of bringing our programs to the clinic in the near future. We
continue our discussions with the FDA regarding the regulatory
pathway for both drugs and have made progress on the chemistry,
manufacturing and control (CMC) activities for hCDR1 including the
production of the drug substance. We look forward to the expected
publication of the results of a Phase 2b trial on our lupus drug
(PRELUDE trial) which shows favorable safety and efficacy data on
over 300 patients and are pleased with the coverage initiated
recently by a US research analyst confirming our belief that our
assets provide significant upside as compared to our current
valuation."
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 focused on late stage clinical development of drugs for the
treatment of lupus and multiple myeloma.
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.
Cautionary Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. 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.
Investor Contacts:
Arrowhead BID, New York
Daniel Renaud or Thomas
Renaud
+1 212 619 6889
enquire@arrowheadbid.com
www.xtlbio.com
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(in US$
thousands, except share and per share amounts)
|
|
Consolidated
Statements of Financial Position - Selected Data
|
|
As
of
|
March
31,
|
|
2015
|
|
2014
|
|
|
|
|
Cash, Cash
Equivalents and bank deposits
|
$
1,753
|
|
$
2,595
|
Working
Capital
|
2,033
|
|
3,485
|
Total
assets
|
5,013
|
|
7,743
|
|
|
|
|
Long term
liabilities
|
$
-
|
|
$
10
|
Total shareholders'
equity
|
4,637
|
|
6,142
|
Non-controlling
interests
|
-
|
|
286
|
|
|
|
|
|
XTL
Biopharmaceuticals, Ltd. and Subsidiaries
|
(in US$
thousands, except share and per share amounts)
|
Consolidated
Statements of Comprehensive Income
|
|
For the three
months ended
|
March
31,
|
|
2015
|
|
2014
|
Research and
Development expenses
|
(42)
|
|
(47)
|
General and
administrative expenses
|
(334)
|
|
(547)
|
Operating
Loss
|
$
(376)
|
|
$
(594)
|
Finance
income
|
$
5
|
|
$
2
|
Finance
expenses
|
(245)
|
|
(5)
|
Finance income
(expenses), net
|
$
(240)
|
|
$
(3)
|
Total loss from
continuing operations
|
$
(616)
|
|
$
(597)
|
|
|
|
|
Total loss from
discontinued operations
|
$
(460)
|
|
$
(164)
|
|
|
|
|
Total loss for the
period
|
$
(1,076)
|
|
$
(761)
|
|
|
|
|
Total loss for the
period attributable to:
|
|
|
|
Equity holders of the
Company
|
$
(1,078)
|
|
$
(686)
|
Non-controlling
interests
|
2
|
|
(75)
|
|
$
(1,076)
|
|
$
(761)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share from continuing and discontinued operations (in U.S.
dollars):
|
|
|
|
From continuing
operations
|
(0.003)
|
|
(0.003)
|
From discontinued
operations
|
(0.002)
|
|
-
|
Total basic and
diluted loss per share (in U.S. dollars)
|
$
(0.005)
|
|
$
(0.003)
|
Weighted average
number of issued ordinary shares
|
233,561,229
|
|
228,309,044
|
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SOURCE XTL Biopharmaceuticals Ltd.