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 December, 2016
Commission File Number:
001-36000
XTL Biopharmaceuticals Ltd.
(Translation of registrant’s name
into English)
5 HaCharoshet
St., Raanana,
4365603, Israel
(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
¨
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): ____
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): ____
Incorporation by Reference: This Form
6-K of XTL Biopharmaceuticals Ltd. is hereby incorporated by reference into the registration statements on Form S-8 (File No. 333-148085,
File No. 333-148754 and File No. 333-154795) and Form F-3 (File No. 333-194338).
xtl
biopharmaceuticals reports THIRD quarter 2016
FINANCIAL results & provides CLINIcAL and Operational UPDATE
RAANANA,
Israel
- (December 6, 2016) –
XTL Biopharmaceuticals Ltd.
(NASDAQ:
XTLB, TASE: XTLB.TA)
(“XTL” or the “Company”), a clinical-stage biopharmaceutical company developing
its lead product for the treatment of autoimmune diseases including lupus, today reported financial results for the three and
nine months ended September 30, 2016, as well as a clinical and operational update on the development program for its lead drug
candidate hCDR1 in the treatment of Systemic Lupus Erythematosus (SLE).
“During the first nine months of
2016 we achieved important milestones towards commencing our Phase 2 hCDR1 study, which we believe is designed to reveal strong
efficacy results for our drug in the treatment of SLE. The trial design is based on very encouraging feedback from the U.S. FDA
regarding BILAG as the efficacy endpoint and 0.5 mg as the weekly dosage of hCDR1. These are parameters that produced successful
results in a prior trial,” stated Josh Levine, CEO of XTL. “We continue to build our hCDR1 IP portfolio with three
patents granted for hCDR1 and the filing of two new patent applications in the US since the beginning of the year. We are also
investigating hCDR1's potential use in other autoimmune indications.”
Clinical and Operational Update:
|
·
|
Prepared to Commence Phase 2 Trial
|
XTL completed the clinical trial
design of its Phase 2 study of hCDR1 in the treatment of SLE. The protocol was designed in consultation with its world renowned
Clinical Advisory Board and based on encouraging feedback from a pre-investigational new drug (IND) meeting package submission
to the U.S. Food and Drug Administration (FDA). The trial design includes a treatment arm dosing weekly at 0.5 mg hCDR1 and BILAG,
a measure of lupus disease activity, as the measure for the primary efficacy endpoint. Data from the prior Phase 2 study clearly
showed a statistically significant effect of a 0.5 mg dose of hCDR1 on the BILAG index. XTL believes the FDA’s guidance will
improve the likelihood of a successful trial. The FDA’s guidance also included parameters on patient inclusion criteria and
patient population for safety requirements for marketing approval.
|
·
|
Production Batches of hCDR1 Ready for
Phase 2 Trial
|
XTL completed production of representative
batches of hCDR1 with BioConnection NV earlier in 2016. These manufactured batches advance XTL’s chemistry, manufacturing
and controls (CMC) program for the planned Phase 2 trial of hCDR1.
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
2
|
|
·
|
Strengthened Intellectual Property
Portfolio
|
During the third quarter, hCDR1
was granted an important patent in Europe titled, “Parenteral Formulations of Peptides for the Treatment of Systemic Lupus
Erythematosus,” which addresses non-oral drug formulations of hCDR1 in the treatment of SLE. Patents were also issued for
hCDR1 in Hungary and Israel earlier this year. In a move to further broaden hCDR1’s intellectual property rights, two new
patent applications were filed with the U.S. Patent and Trademark Office to protect doses of hCDR1 at and below 0.5 mg weekly in
the treatment of SLE.
Financial Overview
XTL reported $2.3 million in cash and cash
equivalents as of September 30, 2016. Funds will be used to advance the hCDR1 clinical program for the treatment of SLE, to investigate
its use in other indications and to identify additional assets for the treatment of other autoimmune diseases.
Research and development expenses for the
quarter ended September 30, 2016 were $35,000 compared with $134,000 for the same period in 2015. For the nine months ended September
30, 2016 research and development expenses were $390,000 compared with $245,000 for the same period in 2015. The year to date increase
reflects the Company's increased investment in the hCDR1 clinical program and preparations for a Phase 2 clinical trial. Development
activities include the completion of the trial design for the planned Phase 2 trial of hCDR1 for the treatment of SLE, production
of the drug product for that trial and investigation of the use of hCDR1 in other autoimmune indications. Initiation of the Phase
2 clinical trial in SLE will require the Company to raise additional capital.
General and administrative expenses for
the three months ended September 30, 2016 were $265,000, in line with the expenditure for the same period in 2015. For the nine
months ended September 30, 2016 general and administrative expenses were $978,000 compared to $1,008,000 in the first nine months
of 2015.
XTL reported an operating loss for the
quarter ended September 30, 2016 of $300,000 compared with $396,000 for the same period in 2015. For the nine-month period ended
September 30, 2016 XTL reported an operating loss of $1,368,000 as compared to $1,253,000 in the first nine months of the prior
year.
The Company reported a total comprehensive
loss for the quarter ended September 30, 2016 of $279,000, or $0.001 per share, compared to $443,000 or $0.002 per share, in the
same period in 2015. For the nine months ended September 30, 2016 XTL reported a total net loss of $1,222,000 or $0.005 per share,
compared to $1,946,000 or $0.008 per share, in the first nine months of 2015. Total net loss in the first nine months of 2015 included
a loss from discontinued operations of $460,000, or $0.002 per share.
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
3
|
XTL Biopharmaceuticals, Ltd. and Subsidiaries
(USD in thousands)
Consolidated Statements of Financial Position - Selected Data
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Cash, Cash Equivalents and bank deposits
|
|
$
|
2,322
|
|
|
$
|
4,300
|
|
|
$
|
3,817
|
|
Other current assets
|
|
|
612
|
|
|
|
487
|
|
|
|
448
|
|
Non-current assets
|
|
|
1,122
|
|
|
|
2,698
|
|
|
|
1,058
|
|
Total assets
|
|
|
4,056
|
|
|
|
7,485
|
|
|
|
5,323
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
$
|
231
|
|
|
$
|
262
|
|
|
$
|
436
|
|
Total shareholders’ equity
|
|
|
3,825
|
|
|
|
7,223
|
|
|
|
4,887
|
|
XTL Biopharmaceuticals, Ltd. and Subsidiaries
(USD in thousands, except per share amounts)
Consolidated Statements of Comprehensive Loss
|
|
Nine
months ended
September
30,
|
|
|
Three
months ended
September
30,
|
|
|
Year
ended
December
31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
2015
|
|
|
|
Unaudited
|
|
|
Audited
|
|
Research and
development expenses
|
|
|
(390
|
)
|
|
|
(245
|
)
|
|
|
(35
|
)
|
|
|
(134
|
)
|
|
|
(578
|
)
|
General and administrative
expenses
|
|
|
(978
|
)
|
|
|
(1,008
|
)
|
|
|
(265
|
)
|
|
|
(262
|
)
|
|
|
(1,419
|
)
|
Impairment of intangible
asset
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,604
|
)
|
Other
loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(10
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
$
|
(1,368
|
)
|
|
$
|
(1,253
|
)
|
|
$
|
(300
|
)
|
|
$
|
(396
|
)
|
|
$
|
(3,611
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
|
34
|
|
|
|
29
|
|
|
|
15
|
|
|
|
10
|
|
|
|
4
|
|
Finance expenses
|
|
|
(6
|
)
|
|
|
(262
|
)
|
|
|
(1
|
)
|
|
|
(57
|
)
|
|
|
(15
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income (expenses), net
|
|
$
|
28
|
|
|
$
|
(233
|
)
|
|
$
|
14
|
|
|
$
|
(47
|
)
|
|
$
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(1,340
|
)
|
|
$
|
(1,486
|
)
|
|
$
|
(286
|
)
|
|
$
|
(443
|
)
|
|
$
|
(3,622
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from discontinued operations
|
|
$
|
-
|
|
|
$
|
(460
|
)
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
(689
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
loss for the period
|
|
$
|
(1,340
|
)
|
|
$
|
(1,946
|
)
|
|
$
|
(286
|
)
|
|
$
|
(443
|
)
|
|
$
|
(4,311
|
)
|
Other comprehensive income
(loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revaluation
of AFS financial assets
|
|
|
118
|
|
|
|
-
|
|
|
|
7
|
|
|
|
-
|
|
|
|
-
|
|
Total
comprehensive loss for the period
|
|
$
|
(1,222
|
)
|
|
$
|
(1,946
|
)
|
|
$
|
(279
|
)
|
|
$
|
(443
|
)
|
|
$
|
(4,311
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period attributable
to:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
|
(1,340
|
)
|
|
|
(1,948
|
)
|
|
|
(286
|
)
|
|
|
(443
|
)
|
|
|
(4,313
|
)
|
Non-controlling
interests
|
|
|
-
|
|
|
|
2
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
|
$
|
(1,340
|
)
|
|
$
|
(1,946
|
)
|
|
$
|
(286
|
)
|
|
$
|
(443
|
)
|
|
$
|
(4,311
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
for the period attributable to:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
|
(1,222
|
)
|
|
|
(1,948
|
)
|
|
|
(279
|
)
|
|
|
(443
|
)
|
|
|
(4,313
|
)
|
Non-controlling
interests
|
|
|
-
|
|
|
|
2
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
|
$
|
(1,222
|
)
|
|
$
|
(1,946
|
)
|
|
$
|
(279
|
)
|
|
$
|
(443
|
)
|
|
$
|
(4,311
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share from continuing and discontinued operations (in U.S. dollars):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From continuing operations
|
|
|
(0.005
|
)
|
|
|
(0.006
|
)
|
|
|
(0.001
|
)
|
|
|
(0.002
|
)
|
|
|
(0.014
|
)
|
From
discontinued operations
|
|
|
-
|
|
|
|
(0.002
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(0.003
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share
for the period
|
|
$
|
(0.005
|
)
|
|
$
|
(0.008
|
)
|
|
$
|
(0.001
|
)
|
|
$
|
(0.002
|
)
|
|
$
|
(0.017
|
)
|
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
4
|
About hCDR1
hCDR1 is a novel compound with a unique
mechanism of action and has clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile,
is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. For more information
please see a peer reviewed article in Lupus Science and Medicine journal (
full article
).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic inflammatory autoimmune
disease involving many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system
and others. The biologic basis of the disease is dysregulation of the immune (defense) system, leading to production of self (auto)
antibodies attacking the normal organs and causing irreversible damage. According to the Lupus Foundation of America, at least
1.5 million Americans have the disease (more than 5 million worldwide) with more than 16,000 new cases diagnosed each year. The
majority of patients are women of childbearing years. There has been only one drug approved by the FDA in the last 50 years and
recently three of the few drugs in advanced development did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd.
(XTL)
XTL Biopharmaceuticals
Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune
diseases including lupus. The Company’s lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of
systemic lupus erythematosus (SLE). Treatments currently on the market for SLE are not effective enough for most patients and some
have significant side effects. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical
studies with data published in more than 40 peer reviewed scientific journals.
XTL is traded
on the Nasdaq Capital Market (NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTLB.TA). 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
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
5
|
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
Form
F-1/A
filed with the U.S. Securities and
Exchange Commission on
November 8
, 2016.
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
6
|
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
|
XTL BIOPHARMACEUTICALS LTD.
|
|
|
|
|
|
|
|
|
|
Date: December 6, 2016
|
By:
|
/s/ Josh Levine
|
|
|
|
Josh Levine
|
|
|
|
Chief Executive Officer
|
|
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