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 October, 2015
Commission File Number: 000-36000
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. 194338).
XTL
Biopharmaceuticals announces agreement with yeda research and development company ltd. to amend license agreement for lupus asset
RAANANA,
Israel - (October 13, 2015) – XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL) (“XTL”
or the “Company”), a clinical-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical
products for the treatment of unmet clinical needs with a focus on treatments for autoimmune diseases, today announced that it
has reached agreement with Yeda Research and Development Company Ltd. (“Yeda”) to amend the development milestones
in the License Agreement signed between the parties in January 2014 for the development of hCDR1 for the treatment of systemic
lupus erythematosus (SLE).
The amended agreement extends the time
for achievement of key development milestones by approximately five additional months including delivery to Yeda of a full protocol
for an upcoming clinical trial on hCDR1, raising an aggregate of US$5 million (of which US$4 million was raised in April 2015),
and commencing a clinical trial on hCDR1 by January 2017.
Josh Levine, Chief Executive Officer of XTL, commented, “We
are pleased with Yeda’s affirmation of their support and confidence in our ability to develop hCDR1 for the treatment of
SLE. The amended agreement recognizes XTL’s efforts to date to advance hCDR1to a clinical trial including: assembling a world-class
Clinical Advisory Board with leading names in SLE, strengthening the Company’s Board with Directors with drug development
and financial market experience, transferring the IND relating to hCDR1from Teva Pharmaceutical Industries Limited to the Company,
manufacturing the drug substance for the upcoming trial, engaging in ongoing discussions with the FDA to seek opportunities to
strengthen hCDR1intellectual property and optimize the regulatory pathway, and raising US $4 million out of the aggregate amount
of US $5 million as required by the License Agreement.”
“We believe the amended agreement
provides XTL with the time needed to properly develop our hCDR1 program and bring the product to an advanced clinical trial in
the near future. We believe our operational plan and activities over the last several months should allow us to achieve the amended
development milestones well within the revised timeline. The recent publication of the encouraging results of a previous Phase
2b trial (the PRELUDE trial) on hCDR1in a peer reviewed article in the Lupus Science and Medicine journal (http://lupus.bmj.com/content/2/1/e000104.full),
showing favorable safety and efficacy data on over 300 patients, further strengthens our commitment to advance the development
of hCDR1 as soon as possible.”
Amir Naiberg, Chief Executive Officer of
Yeda commented: “We are encouraged by the progress that XTL has made to date with hCDR1. We look forward to XTL’s continued
development of the drug for the treatment of SLE.”
| XTL Biopharmaceuticals Ltd. 5 Hacharoshet Street, Raanana, 43656, Israel Tel: +972 9 955 7080; email: ir@xtlbio.com | Page 1 |
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 over 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., a biopharmaceutical
company, focuses on the acquisition, development, and commercialization of pharmaceutical products for the treatment of unmet clinical
needs with a focus on treatments for autoimmune diseases.
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.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals
Ltd.
Tel: +972 9 955 7080
Email: ir@xtlbio.com
www.xtlbio.com
Arrowhead Business and Investment Decisions,
LLC
140 Broadway, 46th Floor, New York, NY
10005
Daniel Renaud or Thomas Renaud
+1 212 619 6889
enquire@arrowheadbid.com
www.abid.co/NASDAQ.XTLB
| XTL Biopharmaceuticals Ltd. 5 Hacharoshet Street, Raanana, 43656, Israel Tel: +972 9 955 7080; email: ir@xtlbio.com | Page 2 |
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 Annual Report on Form 20-F as filed with
the U.S. Securities and Exchange Commission on April 28 2015.
| XTL Biopharmaceuticals Ltd. 5 Hacharoshet Street, Raanana, 43656, Israel Tel: +972 9 955 7080; email: ir@xtlbio.com | Page 3 |
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.
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XTL BIOPHARMACEUTICALS LTD. |
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Date: October 13, 2015 |
By: |
/s/ Josh Levine |
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Josh Levine |
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Chief Executive Officer |
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