Xtl Biopharmaceuticals Ltd. · TASE:XTLB

Xtl Biopharmaceuticals — Investor Presentation (November 2015)

20 slides from Xtl Biopharmaceuticals's investor presentation, November 2015

  1. Slide 1: XTL Biopharmaceuticals

    XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTL) www.xtlbio.com Josh Levine CEO

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements The following slides 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. Forward-looking statement

  3. Slide 3: Introduction: What is XTL?

    Introduction: What is XTL?  XTLbio is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of unmet clinical needs in large markets  Our lead drug is a “world-class” clinical asset: hCDR1 for treatment of SLE (lupus)  SLE is a significant unmet

  4. Slide 4: Corporate Snapshot

    Corporate Snapshot  Headquarters: Raanana, Israel  ADRs trading on the NASDAQ (XTLB) and Ordinary Shares on the Tel-Aviv Stock Exchange (XTL)  Cash ≈ $4.8 million (as of 6/30/2015)  In Q2 2015 raised $4 million from a large US healthcare fund and existing shareholders  Research Coverage: HC Wai

  5. Slide 5: Management Team

    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 (d

  6. Slide 6: Clinical Advisory Board

    Clinical Advisory Board  Dr. Daniel Wallace, Cedars-Sinai Medical Center  Largest lupus practice of its kind in the US; currently running >30 clinical trials  Served as Chairman of the Lupus Foundation of America, receiving the Lupus Foundation of America Award, Achievement Award of the Lupus Res

  7. Slide 7: hCDR1 for the treatment of Lupus

    hCDR1 for the treatment of Lupus 7

  8. Slide 8: SLE: General & Affected Organs & Symptoms

    SLE: General & Affected Organs & Symptoms Systemic “Lupus” Erythematosus (SLE) is a chronic, debilitating inflammatory autoimmune disease, resulting in rheumatologic, dermatological and end-organ manifestations 8

  9. Slide 9: Lupus: Market Overview

    Lupus: Market Overview  Prevalence1  1.5 million patients in U.S. (5 million worldwide) varying across ethnicities/geographies  Vast majority are women / majority between ages of 15 and 45  Prognosis  Dermatologic & musculoskeletal manifestation most common early on  End organs become involved

  10. Slide 10: Lupus: Competitive Landscape

    Lupus: Competitive Landscape  NO completely effective treatments for lupus in the market:  Current treatments: corticosteroids, cytotoxic immune-suppressants (palliative care)  Problems with current treatments: non specific, severe side effects (hypertension, osteoporosis, bone marrow suppression

  11. Slide 11: hCDR1: Unique Mechanism of Action (MOA)

    hCDR1: Unique Mechanism of Action (MOA) hCDR1 is a peptide that down-regulates the SLE-related autoimmune process; potential to be “first in class” and “best in class” drug  Specific upstream immunomodulation through the generation of regulatory T cells  Developed by Prof. Edna Mozes of the The We

  12. Slide 12: Clinical Trial History of hCDR1

    Clinical Trial History of hCDR1  Three clinical trials completed (by Teva): Phase Ia, Ib trials and a Phase II trial  Studies included over 400 patients  Demonstrated to be well tolerated by patients and to have a favorable safety profile  Phase II (PRELUDE) trial  Did not meet primary endpoint

  13. Slide 13: PRELUDE - Secondary Endpoint (Pre-defined/ITT Cohort)

    PRELUDE - Secondary Endpoint (Pre-defined/ITT Cohort) BILAG Responder Analysis at LOV Compared to Baseline (Placebo vs. Edratide 0.5 mg) Substantial effect (p= 0.03) even though steroid withdrawal not enforced (see below) n=83 n=76 13

  14. Slide 14: PRELUDE - Secondary Endpoint (Post Hoc)

    PRELUDE - Secondary Endpoint (Post Hoc) BILAG Complete Responder Analysis (Placebo vs. Edratide 0.5 mg) Subjects with BL Steroids <20 mg daily dosage Subjects with no Steroids at Baseline (n=137; p=0.007) (n=29; p=0.05) n=69 n=68 n=16 n=13 Clear trend toward even more substantial effect with reduced

  15. Slide 15: PRELUDE – Trends in other Secondary Endpoints

    PRELUDE – Trends in other Secondary Endpoints Medicinal Flare Analysis (Post Hoc/ITT Cohort) SLE Responder Index* (Post Hoc/ITT Cohort) p=0.04 p=0.058 * Predefined: an increase of ≥ 5mg daily steroids compared to baseline * SRI in PRELUDE trial was composite measure of disease activity based ** Post

  16. Slide 16: PRELUDE: Recent Peer-Reviewed Article (8/15)

    16 PRELUDE: Recent Peer-Reviewed Article (8/15) Confidential 3-Nov-15

  17. Slide 17: New Trial (2b or 2/3): Improve Probability of Success

    New Trial (2b or 2/3): Improve Probability of Success Proposed trial design is based on: (1) new FDA guidelines; (2) Benlysta trials; and (3) clinical data from PRELUDE - especially the 0.5 mg results in the secondary endpoints PRELUDE Trial Proposed Trial Primary endpoint SLEDAI only BILAG Substant

  18. Slide 18: hCDR1 Development Milestones

    hCDR1 Development Milestones Milestone 2015 2016 2017 Publish PRELUDE Study Results √ CMC – Drug Substance √ Pre-IND Meeting * CMC – Drug Product IND * Trial Enrollment Interim Analysis * √ activity complete 18

  19. Slide 19: Summary

    Summary  hCDR1 for SLE has the potential to be a “first in class” and “best in class” drug  hCDR1 has a unique mechanism of action  SLE is a significant unmet medical need; has shown high interest from Big Pharma  There is no current effective solution on the market  There is a very weak compet

  20. Slide 20: Thank You

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