HERZLIYA, Israel, April 2, 2014 /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 its financial and operational results for the year
ended December 31,
2013.
Company Highlights:
- Reorganized and strengthened management team
- Appointed Josh Levine as CEO in
October 2013
- Named David Kestenbaum as CFO in
January 2014
- Entered exclusive licensing agreement to acquire hCDR1, a
peptide for the treatment of Lupus (Systemic Lupus Erythematosus -
SLE)
- Retained two leading Rheumatology experts as consultants for
initiation of Phase 2 clinical trial for Lupus
- Initiated trading of ADRs on Nasdaq under the ticker symbol
"XTLB"
"We have made significant progress implementing our new strategy
over the past several months by expanding our pipeline of
therapeutic candidates to include a licensing agreement for our
Lupus asset, hCDR1. We have commenced regulatory work for
implementing a Phase 2 clinical trial of rHuEPO for the treatment
of Multiple Myeloma patients. We also expect to initiate a new
Phase 2 trial for hCDR1 by the end of 2014 or early 2015," stated
Josh Levine, CEO of XTL. "To further
strengthen our clinical and corporate operations, we recently
bolstered our team with the appointment of our new CFO,
David Kestenbaum, and the hiring of
key consultants."
"Since there has only been one drug approved in the last 50
years addressing Lupus, there is broad interest among many
physicians that want to be part of our new program. To support the
development of hCDR1, well-known industry experts in the
rheumatology field, Daniel J.
Wallace, MD and Murray
Urowitz, MD, have been retained to assist XTL with our
upcoming Phase 2 trial. We expect to announce additional
appointments that offer us specific expertise as we move ahead with
the Lupus program."
Mr. Levine continued, "In respect to our rHuEPO drug for the
treatment of Multiple Myeloma, we are planning to conduct a
placebo-controlled, double-blind Phase 2 trial to test safety and
efficacy. We have begun the regulatory process to receive an IND
for the drug, which we expect to receive in the second half of
2014. As an expert on multiple myeloma as well as the effect of EPO
on such patients, our medical director, Professor Mittelman, will
be instrumental in all processes related to the Phase 2 clinical
trial.
"Now that we have a strategic plan in place with a strong
product portfolio and have resumed trading on the NASDAQ, I am
confident that we are on track toward advancing our clinical assets
and enhancing shareholder value," concluded Mr.
Levine.
Financial Overview
The Company reported research and
development expenses for the year ended December 31, 2013 of $113,000 compared to $99,000 for the year ended December 31, 2012. General and administrative
expenses for the year ended December 31,
2013 were $2.0 million
compared to $2.8 million for the year
ended December 31, 2012. Excluding
expenses associated with InterCure, Ltd., the Company's medical
device subsidiary, these costs would have been $1.3 million and $2.4
million for the years ended December
31, 2013 and 2012, respectively. This reduction is a result
of lower share-based compensation to officers and directors in
2013.
XTL reported an operating loss for the year ended December 31, 2013 of $2.9
million compared with $2.4
million for the year ended December
31, 2012. The Company reported a net loss for the year ended
December 31, 2013 of $3.7 million compared with $1.7 million for the year ended December 31, 2012. The increased loss was due to
an impairment charge on the intangible assets related to the
InterCure investment.
The Company reported $4.2 million
in cash, cash equivalents and bank deposits as of December 31, 2013.
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, multiple myeloma and schizophrenia.
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 ADRs 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 2,
2014.
Investor Contacts:
Jeffrey
Goldberger / Garth
Russell
KCSA Strategic Communications
Phone: 212-896-1249 / 212-896-1250
Email: jgoldberger@kcsa.com / grussell@kcsa.com
(Tables to Follow)
XTL
Biopharmaceuticals, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Consolidated
Statements of Financial Position - Selected Data
|
|
For the years
ended
|
December
31,
|
|
2013
|
|
2012
|
|
|
|
|
Cash, Cash
Equivalents and bank deposits
|
$
4,165
|
|
$
3,312
|
Working
Capital
|
3,870
|
|
2,143
|
Total
assets
|
8,015
|
|
11,086
|
|
|
|
|
Long term
liabilities
|
$
11
|
|
$
13
|
Total shareholders'
equity
|
6,265
|
|
7,353
|
Non-controlling
interests
|
520
|
|
2,071
|
|
|
|
|
|
Consolidated
Statements of Comprehensive Income
|
|
For the years
ended
|
December
31,
|
|
2013
|
|
2012
|
Revenues
|
$
2,369
|
|
$
938
|
Cost of
Sales
|
(741)
|
|
(380)
|
|
|
|
|
Gross
Profit
|
$
1,628
|
|
$
558
|
|
|
|
|
Research and
Development costs
|
(113)
|
|
(99)
|
Selling and marketing
expenses
|
(1,691)
|
|
(848)
|
General and
administrative expenses
|
(2,048)
|
|
(2,769)
|
Impairment of
intangible assets
|
(1,729)
|
|
-
|
Other gains,
net
|
1,059
|
|
802
|
Operating
Loss
|
$
(2,894)
|
|
$
(2,356)
|
Finance
income
|
$
61
|
|
$
60
|
Finance
expenses
|
(35)
|
|
(15)
|
Financial income,
net
|
$
26
|
|
$
45
|
Earnings (losses)
from investment in associate
|
$
(845)
|
|
$
569
|
Loss for the
Year
|
$
(3,713)
|
|
$
(1,742)
|
|
|
|
|
Other
comprehensive income (loss):
|
|
|
|
Items that might be
classified to profit or loss:
|
|
|
|
Foreign currency
transaction adjustments
|
$
108
|
|
$
114
|
Reclassification of
foreign currency transaction adjustments to Other gains,
net
|
(221)
|
|
-
|
Total other
comprehensive income (loss)
|
$
(113)
|
|
$
114
|
|
|
|
|
Total
comprehensive loss for the year
|
$
(3,826)
|
|
$
(1,628)
|
|
|
|
|
Loss for the year
attributable to:
|
|
|
|
Equity holders of the
Company
|
$
(2,476)
|
|
$
(1,390)
|
Non-controlling
interests
|
(1,237)
|
|
(352)
|
|
$
(3,713)
|
|
$
(1,742)
|
Total
comprehensive loss for the year attributable to:
|
|
|
|
Equity holders of the
Company
|
$
(2,589)
|
|
$
(1,276)
|
Non-controlling
interests
|
(1,237)
|
|
(352)
|
|
$
(3,826)
|
|
$
(1,628)
|
|
|
|
|
Basic and diluted
loss per share (in U.S. dollars)
|
$
(0.01)
|
|
$
(0.01)
|
Weighted average
number of issued ordinary shares
|
223,605,181
|
|
217,689,926
|
SOURCE XTL Biopharmaceuticals Ltd.