XTL Biopharmaceuticals Ltd. · TASE:XTLB

XTL Biopharmaceuticals — Investor Presentation (May 2015)

25 slides from XTL Biopharmaceuticals's investor presentation, May 2015

  1. Slide 1: XTL Biopharmaceuticals

    May 2015 XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTL) www.xtlbio.com

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements The following slides contain forward-looking statements that include, but are not limited to, projections about our business and our future revenues, expenses, activities and profitability. Forward-looking statements involve known and unknown risks, uncertainties and other

  3. Slide 3: XTLbio – Overview

    XTLbio – Overview  XTL is focused on two assets (hCDR1 for SLE/rHuEPO for MM)  Both address a significant unmet medical need  Both have exciting/compelling clinical data  hCDR1 has robust data on >400 patients; efficacy on the FDA recommended endpoint  rHuEPO for MM has shown significant surviv

  4. Slide 4: XTL Assets are Complementary

    XTL Assets are Complementary hCDR1 for SLE Reward rHuEPO for MM Risk (Cost of Development/Time to Additional Data) 4

  5. Slide 5: Corporate Snapshot

    Corporate Snapshot  Headquarters: Raanana, Israel  ADRs trading on NASDAQ (XTLB) Ordinary Shares on Tel-Aviv Stock Exchange (XTL)  Cash (incl. Short Term Deposits): ~$2.2 m (as of Year End 2014)  Raised $4m in Q1 2015 from a large US healthcare fund + existing shareholders  Capitalization:  27

  6. Slide 6: 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 (US) & MBA, CFO CFO, ZenithSolar; Finance Director, Colbar Lifescien

  7. Slide 7: hCDR1 for the treatment of Lupus

    hCDR1 for the treatment of Lupus 8

  8. Slide 8: Lupus: Market Overview

    Lupus: Market Overview Systemic “Lupus” Erythematosus (SLE) is a chronic, debilitating inflammatory autoimmune disease, resulting in rheumatologic, dermatological and end-organ manifestations  Prevalence1  1.5 million patients in the U.S. (5 million patients worldwide) varying across ethnicities a

  9. Slide 9: 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

  10. Slide 10: hCDR1: General & Mechanism of Action (MOA)

    hCDR1: General & 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

  11. Slide 11: Clinical Trial History of hCDR1

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

  12. Slide 12: PRELUDE (Phase II) Trial Design

    PRELUDE (Phase II) Trial Design Non-compliance with Steroid Withdrawal Phase not a protocol violation  Primary endpoint (SLEDAI ) was not met  Secondary and Exploratory Endpoints (BILAG, Flares) showed effect/trends  Edratide seems to have a favorable safety profile and is well tolerated 13

  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 14

  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: 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

  17. Slide 17: New Phase 2b Trial: Improve Probability of Success

    New Phase 2b Trial: 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 Phase 2b Primary endpoint SLEDAI only BILAG Substant

  18. Slide 18: rHuEPO for the Treatment of Multiple Myeloma (MM)

    rHuEPO for the Treatment of Multiple Myeloma (MM) 19

  19. Slide 19: Multiple Myeloma (“MM”): Market Overview

    Multiple Myeloma (“MM”): Market Overview  MM is a severe/incurable malignant hematological cancer of plasma cells  2nd most common hematological cancer (10%) and about 1% of all cancers  In the US there are ~75,000* people living with MM  ~20K* new cases diagnosed annually; ~45K new cases in the

  20. Slide 20: rHuEPO – Drug Overview

    rHuEPO – Drug Overview  Recombinant human erythropoietin (rHuEPO) is a hormone, produced by the kidneys, and is responsible for red blood cell production in bone marrow  Leading branded medicine forms of rHuEPO, include J&J (Procrit® and Eprex®); Roche (NeoRecormon®); and Amgen (Epogen® and Aranes

  21. Slide 21: Clinical Trial History of rHuEPO for Use with MM Patients

    Clinical Trial History of rHuEPO for Use with MM Patients  Clinical observation on advanced MM patients treated with rHuEPO for anemia  A novel biological effect: Patients lived ~36-90 months longer than expected!  Extensive clinical/basic research with human patients and mice models:  rHuEPO ha

  22. Slide 22: rHuEPO for MM: Phase 2 Study

    rHuEPO for MM: Phase 2 Study  Study Design: Study to assess the safety and effect on survival of rHuEpo in patients with advanced multiple myeloma  ~30 patient, open label study to be conducted primarily in Israel  Company already started the regulatory work with the FDA  Regulatory approvals fo

  23. Slide 23: XTLbio – Development Timeline

    XTLbio – Development Timeline1 Publish PRELUDE Begin enrollment Complete Enrollment Interim data Trial Results Regulatory/ CMC Phase II trial Phase II trial Phase II trial 2015 2016 2017 Begin enrollment Complete Enrollment Regulatory Data Phase II trial Phase II trial Phase II trial 1 Subject, in s

  24. Slide 24: XTLbio – Summary

    XTLbio – Summary  XTL is focused on two assets (hCDR1 for SLE/rHuEPO for MM)  Both address a significant unmet medical need  Both have exciting/compelling clinical data  hCDR1 has robust data on >400 patients; efficacy on the FDA recommended endpoint  rHuEPO for MM has shown significant surviva

  25. Slide 25: Thank You

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