<SEC-DOCUMENT>0001144204-16-089049.txt : 20160321
<SEC-HEADER>0001144204-16-089049.hdr.sgml : 20160321
<ACCEPTANCE-DATETIME>20160321083022
ACCESSION NUMBER:		0001144204-16-089049
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160321
FILED AS OF DATE:		20160321
DATE AS OF CHANGE:		20160321

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			XTL BIOPHARMACEUTICALS LTD
		CENTRAL INDEX KEY:			0001023549
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36000
		FILM NUMBER:		161517592

	BUSINESS ADDRESS:	
		STREET 1:		XTL BIOPHARMACEUTICALS LTD
		STREET 2:		C/O ALSTON & BIRD LLP, 90 PARK AVENUE
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10016
		BUSINESS PHONE:		972 9 955 7080

	MAIL ADDRESS:	
		STREET 1:		85 MEDINAT HAYEHUDIM ST.
		STREET 2:		PITUACH, PO BOX 4033
		CITY:			HERZLIYA
		STATE:			L3
		ZIP:			46140
</SEC-HEADER>
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<FILENAME>v434831_6k.htm
<DESCRIPTION>FORM 6-K
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Form 6-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Report of Foreign Private Issuer</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Rule 13a-16 or 15d-16</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of the Securities Exchange Act of 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">For the month of March, 2016</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Commission File Number: <B>000-36000</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>XTL Biopharmaceuticals Ltd.</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Translation of registrant&rsquo;s name
into English)</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>5 HaCharoshet St.,</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Raanana 4365603</B><BR>
<B><U>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Israel&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark whether the registrant files or will
file annual reports under cover Form 20-F or Form 40-F.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif">Form
20-F&nbsp;</FONT><FONT STYLE="font-family: Wingdings">x</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form
40-F&nbsp;<FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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): ____</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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): ____&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>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).</B></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"><FONT STYLE="text-transform: uppercase"><B>xtl
biopharmaceuticals completes phase 2 trial design for lead compound hcdr1 in the treatment of lupus</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>Company to file IND with FDA and plans
to commence trial in 2016</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="text-transform: uppercase"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="text-transform: uppercase"><B>RAANANA,
Israel</B></FONT><B> - (March 21, 2016) &ndash; XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) </B>(&ldquo;XTL&rdquo;
or the &ldquo;Company&rdquo;), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus,
today announced it has completed the clinical trial design for its upcoming Phase 2 study of hCDR1 in the treatment of systemic
lupus erythematosus (SLE). The global study is planned to commence in 2016, following the Company&rsquo;s investigational new drug
(IND) filing with the U.S. Food and Drug Administration (FDA).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The study, developed in consultation with
XTL&rsquo;s Clinical Advisory Board, is based on encouraging feedback received from the FDA in response to the Company&rsquo;s
pre-IND meeting package.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The planned global Phase 2 trial is a double-blind,
placebo controlled 26 week study to evaluate the safety and efficacy of hCDR1 in the treatment of SLE. The study will include three
arms. Two arms will treat subjects with a different hCDR1 weekly dose, one of which will be the 0.5 mg dose which was the most
effective dose tested in the previous Phase 2 study, and the third arm will be placebo. The primary efficacy endpoint of the study
will be the proportion of subjects achieving a favorable response at 26 weeks in at least one organ system. BILAG is a standard
diagnostic measure of the severity of lupus in organ systems and the recommended measure for efficacy for our trial by the FDA.
Data from a prior Phase 2 study clearly showed a statistically significant effect of a 0.5 mg dose of hCDR1 on the BILAG index.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-size: 10pt">Secondary
endpoints include proportions of patients achieving a substantial response by BILAG 2004, </FONT>proportion of patients achieving
a response by SLEDAI-2K Responder Index 50, and additional endpoints presented and accepted by the FDA<FONT STYLE="font-size: 10pt">.
Steroid dosing of subjects will be restricted to improve patient outcomes. Prior studies showed that reduced steroid usage corresponded
with improved efficacy in patients treated with hCDR1.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&ldquo;We worked closely with the world-renowned
lupus experts on our Clinical Advisory Board to develop this study design based on the BILAG index as a measure of hCDR1&rsquo;s
efficacy. The FDA&rsquo;s recent guidance indicating that BILAG is an appropriate efficacy endpoint for our trial was a very significant
and positive milestone. It enabled us to optimize our study design, and in our opinion, improves the likelihood of the study&rsquo;s
success based on the efficacy results of the prior Phase 2 trial when a 0.5 mg dose of hCDR1 was used with the BILAG index,&rdquo;
said Josh Levine, CEO of XTL. &ldquo;We look forward to filing our IND in the U.S. and commencing the trial this year.&rdquo;</P>



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                                         +972 9 955 7080; email: <FONT STYLE="color: Blue"><U>ir@xtlbio.com</U></FONT></P></TD><TD STYLE="width: 33%; text-align: right">&nbsp;Page <!-- Field: Sequence; Type: Arabic; Name: PageNo -->1<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>About hCDR1</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For more information please see a peer
reviewed article in Lupus Science and Medicine journal (<FONT STYLE="color: Blue"><U>http://lupus.bmj.com/content/2/1/e000104.full</U></FONT>).
</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>About Systemic Lupus Erythematosus (SLE)</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>About XTL Biopharmaceuticals Ltd.
(XTL)</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">XTL Biopharmaceuticals
Ltd., is a&nbsp;clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune
diseases including lupus. The Company&rsquo;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&nbsp;40 peer reviewed scientific journals. Based on encouraging safety and efficacy data&nbsp;shown
in a completed Phase 2 study, the Company expects to initiate a Phase 2 trial in 2016.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">XTL is&nbsp;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.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>For further information, please contact:</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Investor Relations, XTL Biopharmaceuticals
Ltd.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Tel: +972 9 955 7080</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Email: <FONT STYLE="color: Blue"><U>ir@xtlbio.com</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Blue"><U>www.xtlbio.com</U></FONT>&#9;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>Cautionary Statement</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This press release may contain forward-looking
statements, about XTL&rsquo;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 &quot;believe,&quot; &quot;expect,&quot; &quot;intend,&quot; &quot;plan,&quot; &quot;may,&quot;
&quot;should&quot; or &quot;anticipate&quot; 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&rsquo;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&rsquo;s actual results to differ materially from any future results expressed or implied by the forward-looking
statements. Many factors could cause XTL&rsquo;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&rsquo;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 Registration Statement
on Form F-1 as filed with the U.S. Securities and Exchange Commission on December 31, 2015.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; text-indent: 0; margin-top: 0pt; margin-bottom: 6pt">&nbsp;</P>

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    <TD COLSPAN="2"><B>XTL BIOPHARMACEUTICALS LTD.</B></TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; width: 50%">Date: March 21, 2016&#9;</TD>
    <TD STYLE="width: 4%">By:&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 46%">/s/ Josh Levine</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top; border-top: #000000 1px solid">Josh Levine<BR>Chief Executive Officer</TD></TR>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
