UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For the month of August, 2008.
Commission
File Number:
000-51310
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant's name into English)
711
Executive Blvd., Suite Q
Valley
Cottage, New York 10989
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F.
Form
20-F
x
Form
40-F
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
o
Indicate
by check mark whether by furnishing the information contained in this Form,
the
registrant is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o
No
x
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
N/A
Incorporation
by Reference: This Form 6-K of XTL Biopharmaceuticals Ltd. dated August 14,
2008
is hereby incorporated by reference into the registration statements on Form
F-3
(File No. 333-141529 and File No. 333-147024) filed by XTL Biopharmaceuticals
Ltd. with the Securities and Exchange Commission on March 23, 2007 and October
30, 2007, respectively, and the registration statements on Form S-8 (File No.
333-148058 and File No. 333-148574) filed by XTL Biopharmaceuticals Ltd. with
the Securities and Exchange Commission on December 14, 2007 and January 18,
2008, respectively.
XTL
Biopharmaceuticals Announces First Half 2008 Financial
Results
Valley
Cottage, New York, August 14, 2008
-
XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB; TASE: XTL), a biopharmaceutical company
engaged in the acquisition and development of therapeutics for the treatment
of
unmet medical needs, particularly diabetic neuropathic pain and hepatitis C,
today announced its financial results for the first half ended June 30,
2008.
At
June
30, 2008, the Company had cash, cash equivalents and short-term bank deposits
of
$8.3 million, compared to $13.0 million at December 31, 2007. The decrease
of
$4.7 million during the six months ended June 30, 2008 was attributable
primarily to operating expenditures associated with the Company’s ongoing
Bicifadine clinical program and to the preclinical hepatitis C program, which
was out-licensed to Presidio Pharmaceuticals, Inc., or Presidio, at the end
of
March 2008, offset by the $4.0 million upfront license payment received from
Presidio. The Company's cash, cash equivalents and short-term bank deposits
of
$8.3 million at June 30, 2008 does not reflect the $2 million due to XTL
pursuant to the amendment of the Presidio license that was signed last week.
The
loss
for the six months ended June 30, 2008 was $7.1 million, or $0.02 per ordinary
share, compared to a loss of $14.6 million, or $0.07 per ordinary share, for
the
comparable period last year, representing a decrease in net loss of $7.5
million. The decreased loss was primarily attributable to a $4.5 million
decrease in research and development costs and the recognition in the 2008
period of the $4.0 million upfront license fee received from Presidio. The
$4.5
million decrease in research and development costs was primarily due to the
absence in the current period of the $7.5 million initial license fee for
Bicifadine incurred during the comparable period last year and the absence
of
$1.3 million in expenses related to the Company’s legacy hepatitis C clinical
programs, offset by a $5.3 million increase in expenses associated with the
ongoing Bicifadine clinical program. For the six months ended June 30, 2008
and
2007, the Company’s losses of $7.1 million and $14.6 million, respectively,
included $1.3 million and $1.0 million, respectively, of non-cash stock option
compensation expense and also included the recognition of a $0.7 million and
$0.6 million charge recorded during the current and comparable period last
year
relating to the fair-value of stock appreciation rights granted as a transaction
advisory fee to certain third party intermediaries in connection with the
Bicifadine transaction.
Commenting
on the results, Ron Bentsur, Chief Executive Officer of XTL, said, “During the
first half of 2008, we consummated the out-licensing of our preclinical
hepatitis C program to Presidio Pharmaceuticals, Inc.” Mr. Bentsur added, “In
June we completed patient randomization into our multi-center, double-blind,
placebo-controlled Phase 2b clinical trial with Bicifadine in diabetic
neuropathic pain. We remain focused on completing this study and expect to
announce results in the fourth quarter of 2008.”
ABOUT
XTL BIOPHARMACEUTICALS LTD.
XTL
Biopharmaceuticals Ltd. (“XTL”) is engaged in the development of therapeutics
for the treatment of diabetic neuropathic pain and HCV. XTL is developing
Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment
of diabetic neuropathic pain, which is currently in a Phase 2b study. XTL has
out-licensed its novel pre-clinical HCV small molecule inhibitor program. XTL
also has an active in-licensing and acquisition program designed to identify
and
acquire additional drug candidates. XTL is publicly traded on the NASDAQ and
Tel-Aviv Stock Exchanges (NASDAQ: XTLB; TASE: XTL).
Contact:
Ron
Bentsur, Chief Executive Officer
Tel:
+1-(845)-267-0707 ext. 225
Cautionary
Statement
Some
of the statements included in this press release, particularly those
anticipating future financial performance, clinical and business prospects
for
our clinical compound for neuropathic pain, Bicifadine, and for our compounds
from our hepatitis C pre-clinical program which was recently out-licensed to
Presidio Pharmaceuticals, Inc., growth and operating strategies and similar
matters, 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. Among the factors that could cause our actual results to
differ materially is our ability to complete in a timely and cost effective
manner clinical trials on Bicifadine, which could directly impact our ability
to
continue to fund our operations; our ability to meet anticipated development
timelines for all of our drug candidates due to recruitment, clinical trial
results, manufacturing capabilities or other factors; the success of our drug
development and marketing arrangements with third parties; and other risk
factors identified from time to time in our reports filed with the Securities
and Exchange Commission, including our annual report on Form 20-F filed with
the
Securities and Exchange Commission on March 27, 2008, including Risks Related
to
Our Financial Condition. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release and prior
releases are available at http://www.xtlbio.com. The information in our website
is not incorporated by reference into this press release and is included as
an
inactive textual reference only.
XTL
Biopharmaceuticals Ltd.
Selected
Consolidated Financial Data
(Thousands
of US Dollars, Except Share and Per Share Data)
Statements
of Operations Information:
|
|
|
Six
months ended June 30,
|
|
|
|
|
(unaudited)
|
|
|
|
|
2008
|
|
2007
|
|
License
Revenues
|
|
|
$
|
3,940
|
|
$
|
227
|
|
Cost
of license revenues
(with respect
to
royalties)
|
|
|
|
--
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
Gross
margin
|
|
|
|
3,940
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
Research
and development costs
(includes
$7,500
initial upfront license fee for the
six
months ended June 30, 2007 and also
includes
non-cash stock option compensation
of
$100 and $66, for the six months ended
June
30, 2008 and 2007, respectively)
|
|
|
|
7,564
|
|
|
12,118
|
|
Less
- participations
|
|
|
|
--
|
|
|
56
|
|
|
|
|
|
7,564
|
|
|
12,062
|
|
General
and administrative expenses
(includes
non-cash
stock option compensation of $1,115
and
$892, for the six months ended
June
30, 2008 and 2007, respectively)
|
|
|
|
2,676
|
|
|
2,523
|
|
|
|
|
|
|
|
|
|
|
Business
development costs
(includes stock
appreciation
rights compensation of $688 and
$565,
and also includes non-cash stock
option
compensation of $48 and $11, for the
six
months ended June 30, 2008 and 2007,
respectively)
|
|
|
|
960
|
|
|
828
|
|
Operating
loss
|
|
|
|
7,260
|
|
|
15,213
|
|
Financial
and other income,
net
|
|
|
|
158
|
|
|
351
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
|
7,102
|
|
|
14,862
|
|
Income
taxes
|
|
|
|
13
|
|
|
(213
|
)
|
|
|
|
|
|
|
|
|
|
Loss
for the period
|
|
|
$
|
7,115
|
|
$
|
14,649
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per ordinary share
|
|
|
$
|
0.02
|
|
$
|
0.07
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of shares used in
computing
basic and diluted loss per
ordinary
share
|
|
|
|
292,732,918
|
|
|
220,145,233
|
|
Balance
Sheet Information:
|
|
|
June
30,
2008
(unaudited)
|
|
December
31,
2007
(audited)
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
|
$
|
3,088
|
|
$
|
2,377
|
|
Short-term
bank deposits
|
|
|
|
5,200
|
|
|
10,600
|
|
Other
receivables and prepaid expenses
|
|
|
|
857
|
|
|
924
|
|
Total
current assets
|
|
|
|
9,145
|
|
|
13,901
|
|
|
|
|
|
|
|
|
|
|
Employee
severance pay funds
|
|
|
|
45
|
|
|
48
|
|
Restricted
long-term deposits
|
|
|
|
62
|
|
|
61
|
|
Property
and equipment - net
|
|
|
|
83
|
|
|
106
|
|
Intangible
assets - net
|
|
|
|
--
|
|
|
11
|
|
Other
Assets
|
|
|
|
50
|
|
|
--
|
|
Total
assets
|
|
|
$
|
9,385
|
|
$
|
14,127
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and shareholders’ equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
|
$
|
4,237
|
|
$
|
3,809
|
|
Other
current liabilities (stock
appreciation
rights)
|
|
|
|
2,248
|
|
|
1,560
|
|
Total
current liabilities
|
|
|
|
6,485
|
|
|
5,369
|
|
|
|
|
|
|
|
|
|
|
Liability
in respect of employee
severance
obligations
|
|
|
|
155
|
|
|
194
|
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
|
6,640
|
|
|
5,563
|
|
|
|
|
|
|
|
|
|
|
Shareholders’
equity:
|
|
|
|
|
|
|
|
|
Ordinary
shares of NIS 0.02 par value
(500,000,000
authorized, 292,805,326 and
292,654,785
issued and outstanding, at June
30,
2008 and December 31, 2007,
respectively)
|
|
|
|
1,445
|
|
|
1,444
|
|
Additional
paid in capital
|
|
|
|
148,277
|
|
|
146,982
|
|
Deficit
accumulated during the
development
stage
|
|
|
|
(146,977
|
)
|
|
(139,862
|
)
|
Total
shareholders’ equity
|
|
|
|
2,745
|
|
|
8,564
|
|
Total
liabilities and shareholders’ equity
|
|
|
$
|
9,385
|
|
$
|
14,127
|
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
|
|
|
|
XTL
BIOPHARMACEUTICALS LTD.
|
|
|
|
Date:
August 14, 2008
|
By:
|
/s/ Ron
Bentsur
|
|
|
|
Ron
Bentsur
Chief
Executive Officer
|