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XTL Biopharmaceuticals Ltd.

Investor Presentation Jan 5, 2017

7116_rns_2017-01-05_28e8b053-8a06-49ad-b257-cdc9d5e44c7f.pdf

Investor Presentation

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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 January, 2017

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 _ 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).

On January 5, 2017, XTL Biopharmaceuticals Ltd. (the "Company") made available an updated investor presentation on its website. A copy of the investor presentation is attached hereto as Exhibit 99.1 and may be viewed on the home page of the Company's website at www.xtlbio.com.

Exhibit No. Description

99.1 Investor Presentation – January 2017

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: January 5, 2017 By: /s/ Josh Levine

Josh Levine Chief Executive Officer

January 2017

XTL Biopharmaceuticals

(NASDAQ: XTLB) (TASE: XTLB.TA)

www.xtlbio.com

Forward Looking Statements

Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on XTL Biopharmaceuticals Ltd.'s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those inclicated by such forward-looking statements. These factors include, but are not limited to, the accuracy of our financial forecasts in our product candidates development activity and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; the timing and cost of the inlicensing, partnering and acquisition of new product opportunities; the timing of expenses associated with product development and manufacturing of the proprietary product candidates that we have acquired, and those that may be inlicensed, partnered or acquired; substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government; and risks related to failure to obtain regulatory clearances or approvals and noncompliance with applicable drug development regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this presentation will be completed or that any product candidate will receive regulator any indication or prove to be commercially successful. Investors should read the risk factors set forth in our Form F-1/A filed with the Securties and Exchange Commission and periodic reports filed with the Securities and Exchange Commission and the Tel Aviv Stock Exchange. While the ist of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and we do not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances, except as required by law.

Highlights

  • · Developing clinical assets for the treatment of autoimmune diseases
    • · Address large markets with high unmet clinical needs
    • · Well-defined clinical pathway and relatively quick time to market
    • · Partner with large Pharma to help fund late stage development
  • · Initial focus on hCDR1 asset for the treatment of:
Indication Preclinical Phase Phase Phase b Phase
SLE (lupus)
Sjogren's Syndrome

· Anticipated Key Development Milestones1:

Indication 2017 2018 2019
SLE IND Approval Last Patient In Final Data
Phase 2b trial initiation Interim Analysis
SS IND Approval Last Patient In
Phase 2 trial initiation Final Data

1 - Future financing may impact development timeline

Corporate Overview

  • = Lead product candidate (hCDR1 or Edratide): for treatment of autoimmune diseases
    • · Novel compound with unique mechanism of action
    • · Clinical data in >400 patients with Systemic Lupus Erythematosus (SLE)
      • · Demonstrated favorable safety profile and well tolerated by patients
      • · "Demonstrated efficacy in ... clinically meaningful endpoints" (Lupus Science & Medicine Journal - August 2015)

  • · Encouraging preliminary data in primary Sjogren's Syndrome (pSS) exhibited, similar to data previously obtained in SLE
  • = Lead indications represent significant unmet medical needs in area of interest
    • · GSK acquired HGS in 2012 primarily for its SLE drug Benlystafor \$3 billion
    • · No effective therapeutic on the market for either indication and weak competitive pipeline
  • · Aim to replicate results achieved in previous Phase 2b trial in SLE
    • · FDA supports efficacy endpoint based on the BILAG index
    • " Improved trial design for SLE based on previous Phase 2b study; FDA "buy in"

hCDR1: Phase II Ready in Two Autoimmune Indications

  • · Peptide that down-regulates autoimmune processes
  • · Developed by Prof. Edna Mozes from Weizmann Institute of Science (Israel)
  • = >40 peer reviewed journal articles; >200 animal experiments
  • · Three clinical studies completed on hCDR1 treating over 400 SLE patients
  • Intellectual Property I
    • Minimum of data/regulatory exclusivity

      • · US: 6.5 7.5 years from approval (5 years plus variable litigation time)
      • EU: 10 years from approval
    • Recently filed two new U.S. Patent Applications for treatment of SLE covering:

      • 0.5 mg and lower doses
      • Specific patient population and/or treatment regimen
    • Recently filed Provisional U.S. Patent Application for treatment of Sjogren's Syndrome

"First in Class" and "Best in Class" Candidate

hCDR1: Unique Mechanism of Action (MOA)

MOA of hCDR1: Different than existing late stage pipeline candidates

Specific upstream immunomodulation through generation of regulatory T cells

6

hCDR1: Treatment of SLE/Lupus

SLE: Affected Organs & Symptoms

· Chronic, debilitating inflammatory autoimmune disease

X

· Resulting in rheumatologic, dermatological and end-organ manifestations

SLE/Lupus: Market Overview

  • Prevalence1 I
    • = 1.5 million patients in U.S. (5 million worldwide) across various ethnicities/geographies
    • · Vast majority at onset are women / majority between ages of 15 and 45
  • I Prognosis
    • · Dermatologic & musculoskeletal manifestations are the most common but major organ involvement such as renal, central nervous system and serosal occur frequently
    • · Major organs may become involved as disease progresses
    • · Most common causes of death
      • · Initial active disease or infection
      • · Later Renal failure, Cardiovascular disease, CNS disorders
    • · 80-90% of patients survive beyond 10 years1
  • · Market expected to grow dramatically

1Lupus Foundation of America

SLE/Lupus: Competitive Landscape

  • · Current treatments: anti-malarials, corticosteroids, immunosuppressants, cytotoxics
    • · Problems with current treatments: severe side effects (hypertension, osteoporosis, bone marrow suppression, increased cancer risk, etc.)
  • · Benlysta (HGS/GSK): approved by FDA March 2011
    • · Only lupus drug approved in the last 50+ years; 2015 sales of £230m (GSK 2015 francials)
  • · Current pipeline: primarily B-cell inhibitors like Benlysta
    • · Recent Phase III failures: UCB/Lilly/Anthera
    • · Aurinia "success" in Lupus Nephritis: FDA allows single Phase 3 study (following P2b study); recently raised \$28M to fund Phase 3 program

hCDR1 (Edratide): Clinical Trial History

  • · Three clinical trials completed (by Teva): Phase la, Ib and Ilb trials
    • · Over 400 patients enrolled in prior trials
    • · Well tolerated and demonstrated favorable safety profile
  • · Phase Ilb (PRELUDE) trial (conducted by Teva)
    • · Did not meet primary endpoint (SLEDAI)
    • · Did not enforce steroid withdrawal algorithm
    • Encouraging results in secondary clinical endpoint, BILAG index (see below)
      • = 0.5 mg weekly dose showed a substantial effect
  • Opportunity
    • Teva returned to Yeda in 2009 and XTL in-licensed in 2014
    • · FDA published revised guidelines in 2010 with BILAG as preferred primary endpoint

Encouraging Phase Ilb results based on secondary endpoint (BILAG index) Primary endpoint confirmed by FDA pre-IND written response for planned XTL sponsored trial

PRELUDE - Secondary Endpoint (Pre-defined/ITT Cohort)

BILAG Responder Analysis at LOV Compared to Baseline (Placebo vs. Edratide 0.5 mg)

PRELUDE - Secondary Endpoint (Post Hoc)

BILAG Complete Responder Analysis (Placebo vs. Edratide 0.5 mg)

PRELUDE: Peer-Reviewed Publication (August 2015)

Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study

Murray B Urowitz,1 David A Isenberg,2 Daniel J Wallace3

· Edratide demonstrated efficacy in one and pos-
sibly more clinically meaningful endpoints.
Dose ranging studies demonstrated the 0.5 mg
subcutaneous weekly was the most effective
dose.
There were no satety signals in this 26 week
study.
TILbio Urowitz MB, Isenberg DA, Wallace DJ. Lupus Science & Medicine 2015:2:000104. doi:10.1136/lupus-2015-000104

5-Jan-17

XTL Sponsored Trial: Improve Probability of Success

Proposed trial design based on: (1) FDA written guidance; (2) Benlysta trials; and (3) clinical data from PRELUDE - especially the 0.5 mg results in BILAG endpoint

PRELUDE Trial Proposed Trial
Primary endpoint SLEDAl only BILAG Substantial Responders
Dose 0.5, 1, 2.5 mg 0.5 mg and lower
Steroid Use < 40 mg daily dose at baseline
Steroid sparing not enforced
Lower daily dose at baseline (<15 mg)
Defined steroid reduction regimen
Trial duration 26 weeks 26 weeks
Execution Site discrepancies in disease matrices
Suboptimal sample & data handling
Training and monitoring
Specialized CRO

FDA Guidance (written response dated January 19, 2016)

  • · Phase 2 study with a primary efficacy endpoint to be based on BILAG index
  • · Reduced steroid usage and elevated anti ds-DNA levels in patient population (and other inclusion citeria)
  • · Reasonable number of patients required to prove safety for marketing approval

hCDR1 for SLE: Development Milestones

Milestone 2016 2017 2018
Pre-IND Meeting V
Finalize phase 2b trial design V
CMC - Drug Product production & testing V
New Patent Applications filed V
IND Approval *
Trial Enrollment
Initial Clinical Data *

16

hCDR1: treatment of Sjögren's Syndrome (SS)

SS: Affected Organs & Symptoms

Chronic autoimmune inflammatory disorder characterized by diminished lacrimal and salivary gland function that may affect multiple organs/systems

Two types of SS (~50/50):

  • · Primary SS (pSS): SS patient who does not have another major rheumatic and/or autoimmune disease
  • · Secondary SS: secondary to another autoimmune disease

SS: Market Overview

  • Prevalence I
    • = ~ 0.7% of U.S. population-estimated 2.5 to 4 million patients2
    • · Vast majority at onset are women (at least 9:1)2
    • · Average age at diagnosis: 40-50 years2
    • · Market expected to grow to 3.5 million cases globally by 20241
  • . Prognosis
    • · Hallmark symptoms are dry eyes/mouth, fatigue and joint pain
    • · May impact other organs (extra-glandular): kidneys, gastrointestinal system, blood vessels, lungs, liver, pancreas and nervous system
    • · Increased risk of non-Hodgkin's B cell lymphoma (relative risk: 13x chance of developing disease vs. general population)1
    • = ~ 70% of patients have anti-Ro (SS-A) ; ~ 40% of patients have anti-La (SS-B)2

1 Global Data Research 2016 2 Sjogren's Syndrome Foundation

SS: Competitive Landscape

  • · No approved treatment for the systemic manifestations of the disease
  • · Two approved symptomatic treatments
    • · Salagen (pilocarpine; Eisai, 1998) and Evoxac (cevilemine; Daichi, 2000)
  • · Immunomodulatory treatments (usually for extra-glandular disease)
    • · Cyclosporine (ocular inflammation)
    • = Hydroxychloroquine (mild inflammatory symptoms of joints, muscles & skin)
    • · Corticosteroids (for serious symptoms)
    • · Immunosuppressive agents: used to treat serious internal organ manifestations
    • · Biologic agents: rituximab (off-label use)
  • · Competitive pipeline: only 1 Phase III product
    • · Orencia (BMS) approved for Rheumatoid Arthritis
      • · 1 open-label proof-of-concept study and then straight to Phase 3
    • · Other trials off-label use of drugs approved for other autoimmune diseases

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hCDR1: Pre-clinical Study Data on pSS Patients

  • · Blood mononuclear cells (PBMC) from blood samples of patients with pSS incubated in-vitro with hCDR1 and a control peptide
  • · Promising in-vitro/ex-vivo study results:
    • = Significant reduction in gene expression of 3 cytokines considered to be pathogenic in SS
    • · Similar to results in SLE patients using same method
  • · Similar studies in PBMCs of RA and APS patients yielded no significant effect

Reduction in Gene Expression of 3 Cytokines

hCDR1: Upcoming (Phase 2) Study in pSS

  • · Safety of hCDR1 in humans already established in SLE patients
  • = First clinical trial in pSS will be a controlled Phase 2 study
    • · Study objectives: Safety & efficacy of different doses of hCDR1 in pSS patients
    • · 3-arm study 2 doses plus control
    • · Study duration: 3 months active treatment
    • N~50 patients .
Milestone 2017 2018
Patent Application Filed *
IND Approval *
Trial Initiation (FPI)
Clinical Data

22

Management Team

Josh Levine, CEO

CEO, Proteologics; Senior Director, Teva Pharmaceuticals (Innovative Ventures); Partner, Platinum Neurone Ventures; Corporate Finance Head, Patterson Travis; Attorney, WF&G

David Kestenbaum, CPA & MBA, CFO

CFO, ZenithSolar; Finance Director, Colbar Lifescience (division of J&J (NYSE:JNJ)); CFO, ZAG Industries (division of The Stanleyworks (NYSE:SWK)); CFO, Lever Israel (division of Unilever (NYSE:UN)); Sr. Associate, PwC; New York

Dr. Daphna Paran, Medical Director

Senior lecturer: Tel Aviv University; Head of Day Care unit/Deputy Head of the Department of Rheumatology; Tel Aviv Medical Center (Ichilov Hospital); Trained at Rayne Institute, St. Thomas Hospital, London; Published/co-authored >60 articles on rheumatology and lupus

Monique Ben Am, MSc, Clinical Development Lead

VP Clinical Development, BioCancell; Director, TevaPharmaceuticals Ltd.; VP Clinical, Topspin; Associate Director, Novartis (development of Gleevec™)

Clinical Advisory Board

  • · Dr. Daniel Wallace, Cedars-Sinai Medical Center; Largestlupuspractice of its kind in the US
    • = Former Chairman of the Lupus Foundation of America (LFA), received LFA Award, Lupus Research Institute Achievement Award and others
  • · Professor David Isenberg, University College London Hospitals
    • · Chair of the British Isles Assessment Group (BILAG), President of the British Society for Rheumatology (2004-2006) and Chair of its Biologics Register Committee (2006-2011)
  • = Dr. Murray Urowitz, University of Toronto; Lupus Clinic at Toronto Western Hospital
    • Established University of Toronto Lupus Clinic and Lupus Databank Research Program.
    • = Founding member/president of numerous lupus associations and recipient of numerous awards for his contributions to lupus research.
  • · Dr. Lee Simon, Former Division Director, US FDA
    • · Former US FDA Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products and practicing Rheumatologist for 36 years.
    • = Awarded 2003 ACR Distinguished Service Award and Scientific Leadership Award of the Lupus Research Institute.

Corporate Snapshot

  • · Headquarters: Raanana, Israel
  • · Member: Corporate Advisory Council of the Lupus Foundation of America
  • = ADRs trading on NASDAQ (XTLB) and Ordinary Shares on TASE (XTLB.TA)
  • · Capitalization (as of December 31, 2016):
    • · 274,205,799 Shares Outstanding*
    • · Warrants to purchase 961,111 ADRs* @ \$2.25 (expire March 2020)
  • · Member, Corporate Advisory Council, Lupus Foundation of America

Summary

  • Lead candidate (hCDR1): for treatment of autoimmune diseases
    • · Novel compound with unique mechanism of action
    • · Ready for two Phase 2 studies in different autoimmiune indications
    • · Clinical data in > 400 SLE patients
      • = "Demonstrated efficacy in ... clinically meaningful endpoints"
    • Encouraging preliminary data in primary Sjogren's Syndrome (pSS)
      • · Similar to data previously obtained in SLE
  • · Lead indications represent unmet medical needs in areas of interest
    • · GSK acquired HGS/Benlystain 2012 for \$3 billion
    • · No effective therapeutic on the market for either indication
    • · Weak competitive pipeline
  • · Aim to replicate results achieved in previous Phase 2b trial
    • = FDA supports efficacy endpoint based on the BILAG index

XTLbio

Thank You

www.xtlbio.com

27

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