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 June, 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 first quarter 2016 FINANCIAL results & provides CLINIcAL and Operational UPDATE
RAANANA,
Israel
- (June 1, 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 lupus, today announced financial results for the three months ended March 31, 2016 and provided
an update on the development program for its lead drug candidate hCDR1 in the treatment of Systemic Lupus Erythematosus (SLE).
“We achieved numerous milestones
in the first quarter including key clinical events that move hCDR1 towards an upcoming Phase 2 trial designed to have a high likelihood
of success based on prior clinical study findings. We strengthened our intellectual property portfolio, advanced chemistry, manufacturing
and controls for hCDR1, and added a world renowned thought leader as our Medical Director,” said Josh Levine, CEO of XTL.
Clinical and Operational Update
|
·
|
Received Encouraging Feedback from
U.S. FDA
|
In January, XTL announced it
received very encouraging feedback from the U.S. Food and Drug Administration (FDA) in response to its pre-investigational new
drug (IND) meeting package for hCDR1. This successful outcome included BILAG, a measure of lupus disease activity, as the primary
efficacy endpoint. Based on prior positive efficacy data using BILAG as the measure, 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.
|
·
|
Received European Medicines Agency’s
SME Status
|
In February, XTL announced it
received the European Medicines Agency’s Small or Medium Sized Business Enterprise (SME) status in Europe, offering numerous
benefits including fee reductions for pre and post marketing phases, scientific and procedural advice, and eligibility for funding
and grants.
|
·
|
Completed Production of Representative
Batches of hCDR1
|
In February, XTL completed production
of representative batches of drug product with BioConnection NV to advance its chemistry, manufacturing and controls (CMC) program
for the planned Phase 2 trial of hCDR1.
|
·
|
Granted Patent in Israel
|
In
February, XTL announced hCDR1 was granted a patent in Israel titled, “Pharmaceutical Compositions Comprising a Peptide and
a Substituted ß Cyclodextrin for use in Treating Systemic Lupus Erythematosus and Processes for their Manufacture,”
which addresses the
p
harmaceutical composition
and manufacturing processes of hCDR1.
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
1
|
|
·
|
Completed Phase 2 Trial Design
|
In March, XTL announced completion
of the Phase 2 clinical trial design for hCDR1 in the treatment of SLE, in consultation with its world renowned Clinical Advisory
Board. The trial design includes a treatment arm dosing weekly at 0.5 mg hCDR1 and BILAG 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.
|
·
|
Granted Patent in Hungary
|
In March, XTL announced the Hungarian
Intellectual Property Office granted a patent for hCDR1 in the treatment of lupus titled "Synthetic Human Peptides and Pharmaceutical
Compositions Comprising Them for the Treatment of Systemic Lupus Erythematosus."
|
·
|
Appointed Medical Director
|
In March, XTL appointed Dr. Daphna
Paran, a world renowned expert in the treatment of lupus and an internal medicine and rheumatology specialist, as Medical Director.
Financial Overview
XTL reported $3.1 million in cash, cash
equivalents and bank deposits as of March 31, 2016. Funds will be used to advance the hCDR1 clinical program for the treatment
of SLE.
Research and development expenses for the
quarter ended March 31, 2016 were $233,000 compared with $42,000 for the same period in 2015, reflecting the Company's increased
investment in the hCDR1 clinical program and preparations for a Phase 2 clinical trial. First quarter development activities included
the completion of the trial design for the planned Phase 2 trial of hCDR1 for the treatment of SLE and production of the drug product
for that trial.
General and administrative expenses for
the three months ended March 31, 2016 were $369,000 compared with $334,000 for the same period in 2015.
XTL reported an operating loss for the
quarter ended March 31, 2016 of $602,000 compared with $376,000 for the same period in 2015 reflecting increased spending on research
and development. The Company reported a total net loss for the period ended March 31, 2016 of approximately $600,000 or $0.002
per share, compared to $1.1 million or $0.005 per share in the same period in 2015. Total net loss in the first quarter of 2015
included a loss from discontinued operations of approximately $689,000.
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
2
|
XTL Biopharmaceuticals, Ltd. and Subsidiaries
(USD in thousands)
Consolidated Statements of Financial Position - Selected Data
|
|
As of
|
|
|
|
March 31,
|
|
|
|
2016
|
|
|
2015
|
|
Cash, Cash Equivalents and bank deposits
|
|
$
|
3,109
|
|
|
$
|
1,753
|
|
Other current assets
|
|
|
527
|
|
|
|
636
|
|
Non-current assets
|
|
|
1,122
|
|
|
|
2,624
|
|
Total assets
|
|
|
4,758
|
|
|
|
5,013
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
$
|
372
|
|
|
$
|
376
|
|
Total shareholders’ equity
|
|
|
4,386
|
|
|
|
4,637
|
|
XTL Biopharmaceuticals, Ltd. and Subsidiaries
(USD in thousands, except per share amounts)
Consolidated Statements of Comprehensive Income
- Selected Data
|
|
For the three months ended
|
|
|
|
March 31,
|
|
|
|
2016
|
|
|
2015
|
|
Research and Development expenses
|
|
|
(233
|
)
|
|
|
(42
|
)
|
General and administrative expenses
|
|
|
(369
|
)
|
|
|
(334
|
)
|
Operating Loss
|
|
$
|
(602
|
)
|
|
$
|
(376
|
)
|
Finance income
|
|
$
|
27
|
|
|
$
|
5
|
|
Finance expenses
|
|
|
(2
|
)
|
|
|
(16
|
)
|
Finance income (expenses), net
|
|
$
|
25
|
|
|
$
|
(11
|
)
|
Total loss from continuing operations
|
|
$
|
(577
|
)
|
|
$
|
(387
|
)
|
|
|
|
|
|
|
|
|
|
Total loss from discontinued operations
|
|
$
|
-
|
|
|
$
|
(689
|
)
|
Total loss for the period
|
|
$
|
(577
|
)
|
|
$
|
(1,076
|
)
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
Revaluation of AFS financial assets
|
|
$
|
27
|
|
|
$
|
-
|
|
Total comprehensive loss for the period
|
|
$
|
(550
|
)
|
|
$
|
(1,076
|
)
|
|
|
|
|
|
|
|
|
|
Total loss for the period attributable to:
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
$
|
(577
|
)
|
|
$
|
(1,078
|
)
|
Non-controlling interests
|
|
|
-
|
|
|
|
2
|
|
|
|
$
|
(577
|
)
|
|
$
|
(1,076
|
)
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period attributable to:
|
|
|
|
|
|
|
|
|
Equity holders of the Company
|
|
$
|
(550
|
)
|
|
$
|
(1,078
|
)
|
Non-controlling interests
|
|
|
-
|
|
|
|
2
|
|
|
|
$
|
(550
|
)
|
|
$
|
(1,076
|
)
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share from continuing and discontinued operations (in U.S. dollars):
|
|
|
|
|
|
|
|
|
From continuing operations
|
|
|
(0.002
|
)
|
|
|
(0.003
|
)
|
From discontinued operations
|
|
|
-
|
|
|
|
(0.002
|
)
|
Total basic and diluted loss per share (in U.S. dollars)
|
|
$
|
(0.002
|
)
|
|
$
|
(0.005
|
)
|
Weighted average number of issued ordinary shares
|
|
|
273,646,688
|
|
|
|
233,561,229
|
|
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
3
|
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 (
http://lupus.bmj.com/content/2/1/e000104.full
).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic 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 a defect in 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 two 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. Robust clinical data on hCDR1 has been produced 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
4
|
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 prices 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, except as may be required
under applicable law. Please see the risk factors associated with an investment in our ADSs or ordinary shares which are included
in our Form 20-F filed with the U.S. Securities and Exchange Commission on March 31, 2016.
|
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080; email:
ir@xtlbio.com
|
Page
5
|
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: June 1, 2016
|
|
By:
|
|
/s/
Josh Levine
|
|
|
|
|
|
Josh
Levine
|
|
|
|
|
|
Chief Executive Officer
|
|
XTL Biopharmaceuticals (NASDAQ:XTLB)
Historical Stock Chart
From Jun 2024 to Jul 2024
XTL Biopharmaceuticals (NASDAQ:XTLB)
Historical Stock Chart
From Jul 2023 to Jul 2024