XTL Biopharmaceuticals Ltd. · TASE:XTLB

XTL Biopharmaceuticals — Investor Presentation (January 2014)

48 slides from XTL Biopharmaceuticals's investor presentation, January 2014

  1. Slide 1: XTL Biopharmaceuticals

    January 2014 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: Investment Proposition

    Investment Proposition (NASDAQ: XTLB / TASE:XTL)  Focusing on the in-licensing and development of late-stage clinical assets to treat serious unmet medical needs in large markets  Assets have a well-defined path, quick time to market  Partner drug to big pharma after Phase II development  Three

  4. Slide 4: Corporate Snapshot

    Corporate Snapshot (Nasdaq: XTLB)  Headquarters: Herzliya Pituach, Israel  ADRs trading on the NASDAQ (symbol: XTLB) and on the Tel-Aviv Stock Exchange(symbol: XTL)  Current Price: $3.80 (as of 1/22/14)  Average Volume (3 months): 7,834  Market Cap: ~$53 million  Cap Structure: Common, no debt

  5. Slide 5: Management Team Experience

    Management Team Experience  Josh Levine, CEO CEO, Proteologics Ltd; Senior Director, Teva Pharmaceuticals (Innovative Ventures); Partner, Platinum Neurone Ventures (Israeli VC); Head of Corporate Finance, Patterson Travis; Corporate Attorney, Willkie Farr & Gallagher  David Kestenbaum, CPA & MBA,

  6. Slide 6: Mid to Late Stage Focus: Ideal Investment Opportunity

    Mid to Late Stage Focus: Ideal Investment Opportunity 6

  7. Slide 7: Product Pipeline

    Product Pipeline Bris Qommund Preclinical Phase! Phase ll ~Phase lb Phase Ill Therapeutic Area SLE Multiple Myeloma EC Schizophrenia 11 XTLbio

  8. Slide 8: hCDR1 for the treatment of Lupus

    hCDR1 for the treatment of Lupus 8

  9. Slide 9: Systemic Lupus Erythematosus (SLE)

    Systemic “Lupus” Erythematosus (SLE) Lupus is a chronic, debilitating inflammatory autoimmune disease, resulting in rheumatologic, dermatological and end-organ manifestations 9

  10. Slide 10: Lupus: Market Overview

    Lupus: Market Overview  Prevalence  1.5 million patients in the U.S. (5 million patients worldwide)1 varying across ethnicities and geographies  90% are women / 80% between ages of 15 and 45  Prognosis  Dermatologic & musculoskeletal manifestation most common early on  End organs become involv

  11. Slide 11: Lupus: Competitive Landscape

    Lupus: Competitive Landscape  Current treatments used for Lupus (NO completely effective treatments in market):  Corticosteroids, cytotoxic immune-suppressants (palliative care)  Non specific, severe side effects (hypertension, osteoporosis, bone marrow suppression, increased cancer risk, etc.) 

  12. Slide 12: hCDR1 for the treatment of Lupus

    hCDR1 for the treatment of Lupus hCDR1 is a peptide that down-regulates the SLE-related autoimmune process  Specific upstream immunomodulation through the generation of regulatory T cells  Developed by Prof. Edna Mozes of the The Weizmann Institute of Science (Israel)  XTL obtained exclusive lice

  13. Slide 13: Animal Data: Beneficial Effects of hCDR1

    Animal Data: Beneficial Effects of hCDR1 (NZBxNZW)F1 Lupus-prone mice BALB/c mice with induced Lupus 10 s.c. weekly injections with Edratide or control peptide (or just vehicle) Anti-dsDNA antibodies Proteinuria * p< 0.05 * p< 0.05 Immune complex deposits 13

  14. Slide 14: 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 (PRELUDE) trial  Did not meet primar

  15. Slide 15: PRELUDE Trial Design

    PRELUDE Trial Design  Primary endpoint (SLEDAI ) was not met  Secondary and Exploratory Endpoints (BILAG, Flares) showed positive trends  Edratide seems to have a favorable safety profile and is well tolerated 15

  16. Slide 16: PRELUDE - Secondary Endpoint

    PRELUDE - Secondary Endpoint PrePost-Hoc Defined Post-Hoc BILAG Complete Responder at LOV compared to baseline ITT Cohort (N=316) OR (Odds Ratio) [95%CL] LR Test The 0.5 mg dose had Lower Upper Value Limit Limit P-Value a substantial effect Comparison (see next slide) 0.5 mg vs Placebo 2.09 1.07 4.1

  17. Slide 17: PRELUDE - Secondary Endpoint (Pre-defined)

    PRELUDE - Secondary Endpoint (Pre-defined) BILAG Responder Analysis at LOV Compared to Baseline (Placebo vs. Edratide 0.5 mg) Substantial effect even though steroid withdrawal was not enforced (see below) n=83 n=76 17

  18. Slide 18: PRELUDE - Secondary Endpoint (Post Hoc)

    PRELUDE - Secondary Endpoint (Post Hoc) BILAG Complete Responder Analysis (Placebo vs. Edratide 0.5 mg) Subjects with BL Steroids Subjects with no Steroids <20 mg daily dosage (n=137) at BL (n=29) n=69 n=68 n=16 n=13 Clear trend toward even more substantial effect with reduced steroid use 18

  19. Slide 19: New Phase 2b Trial: To Improve Probability of Success

    New Phase 2b Trial: To Improve Probability of Success Proposed trial design is based on:  FDA guidelines*  Benlysta trials as a case study  Lessons learned from PRELUDE PRELUDE Trial Proposed Phase 2b Primary endpoint SLEDAI only BILAG Substantial Responders Dose 0.5, 1, 2.5 mg 0.5, 0.25 mg Corti

  20. Slide 20: rHuEPO for treatment of multiple myeloma (MM)

    rHuEPO for treatment of multiple myeloma (MM) 20

  21. Slide 21: Multiple Myeloma (MM): Market Overview

    Multiple Myeloma (“MM”): Market Overview  MM is a severe and incurable malignant hematological cancer of plasma cells  Average age at diagnosis is 65-70 years; with a median survival is still: 4-5 years  MM is the second most common hematological cancer (10%) and about 1% of all cancers  In the

  22. Slide 22: Multiple Myeloma – Competitive Landscape

    Multiple Myeloma – Competitive Landscape  There are several lines of treatment – mainly combinations of drugs/treatments  IMIDs: Thalidomide ®, Lenalidomide (Revlimid ®), Pomalidomide (Pomalis®)  Proteasome inhibitors: Bortezomib (Velcade ®), Carfilzomib (Kyprolis®) (+Steroids)  Chemotherapy: Me

  23. Slide 23: 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 the bone marrow  Leading branded medicine forms of rHuEPO, include J&J (Procrit® and Eprex®); Roche (NeoRecormon®); and Amgen (Epogen® and Ar

  24. Slide 24: 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 (1990s; Prof. Mittelman):  Corrected the anemia (Hb rise) – known effect  Reduced blood transfusion requirements  Improved quality of life  A novel biological e

  25. Slide 25: rHuEPO for MM: Phase 2 Study

    rHuEPO for MM: Phase 2 Study  Received patent (in U.S., Europe, Israel, Canada, Hong Kong and Japan) and orphan drug designation  Provides 7 years marketing exclusivity in the U.S., from the date of drug approval  Company already started the regulatory work toward receipt of the IND  IND expecte

  26. Slide 26: SAM-101 for treatment of schizophrenia

    SAM-101 for treatment of schizophrenia Schizophrenia networks in prefrontal cortex 26

  27. Slide 27: Schizophrenia: Market Overview

    Schizophrenia: Market Overview Schizophrenia is a severe brain disorder in which people interpret reality abnormally, which may result in some combination of hallucinations, delusions, and disordered thinking and behavior. Estimated market of $6.4 billion in 2010 (According to Decision Resources). A

  28. Slide 28: SAM-101 for Schizophrenia: Drug Overview

    SAM-101 for Schizophrenia: Drug Overview  SAM-101 is a combination therapy: existing antipsychotic drug + minocycline (acts synergistically to provide an optimal treatment of schizophrenia)  Minocycline is a commonly prescribed anti-microbial and anti-inflammatory drug  Effectively crosses the bl

  29. Slide 29: SAM-101: Addresses unmet needs

    SAM-101: Addresses unmet needs Negative symptoms SAM101 showed significant improvement in treatment negative symptoms Cognitive symptoms SAM101 showed significant improvement in treatment various cognitive symptoms Better side- Less patients in treatment group showed weight gain and effect profile m

  30. Slide 30: SAM-101: Independent Clinical Studies: Schizophrenia Patients

    SAM-101: Independent Clinical Studies: Schizophrenia Patients Independent studies demonstrate efficacy of combination therapy, SAM-101 Daily # of pat. Duration Stage of Location Dose Type of trial Study Endpoints (C/R) (months) (mino) disease Primary: negative Secondary: 200 mg First episode - Doubl

  31. Slide 31: SAM-101: Independent Clinical Study Results

    SAM-101: Independent Clinical Study Results Israeli Study Manchester Study Results Reduced Negative Symptoms (SANS): Reduced Negative Symptoms (PANSS Negative): flattening, apathy, alogia, asociality, flattening, apathy, alogia, asociality, disturbance in disturbance in attention attention Improved

  32. Slide 32: SAM-101: Potential for Phase 2b

    SAM-101: Potential for Phase 2b  Ongoing market research is currently being conducted with KOLs (Defined Health)  KOLs interviewed to date agree that SAM101 promises to address a major unmet need in the treatment of schizophrenia  Key points of KOL interest in the SAM-101 program:  MoA - combine

  33. Slide 33: Summary and Next Steps

    Summary and Next Steps XTLbio

  34. Slide 34: XTLbio – Next Steps

    XTLbio – Next Steps1  hCDR1:  Finalizing CAB/Protocol ongoing  Regulatory work including CMC for 0.25 mg dose  “First Patient In” Phase IIb expected end 2014/beginning 2015  “Last Patient In” expected 12 months later  Interim data (mid-2016) 2  rHuEPO for MM  Regulatory process with FDA ongo

  35. Slide 35: XTLbio – Summary

    XTLbio – Summary  Company has three Phase II assets  Each addresses a significant unmet medical need  Each has interesting and/or compelling clinical data  Each has a game plan that, if successful, should result in significant value appreciation  Such game plan should result in significant clin

  36. Slide 36: Thank you!

    > Oo > =~ Cc © <= = XTLbio

  37. Slide 37: Backup Slides – hCDR1 for Lupus

    Backup Slides – hCDR1 for Lupus 37

  38. Slide 38: PRELUDE – Secondary Endpoint; BILAG Responders

    PRELUDE – Secondary Endpoint; BILAG Responders Pre Defined BILAG Responder Definition: Substantial Responder (SR) - All systems at LOV are either C or D/E provided that at least one system was either A or B at baseline. Partial Responder (PR) - At least one system improved and at least one system wi

  39. Slide 39: Backup Slides – SAM 101

    Backup Slides - SAM 101 XTLbio

  40. Slide 40: Israeli Phase IIa SAM-101 Study Design

    Israeli Phase IIa SAM-101 Study Design Large-scale (54 randomized patients), prospective, double blind, placebo control trial Phase I – 3 w Phase II – 24 w Stabilization Continuation Open phase Double-blind Screening Baseline Randomization n=36 n=13 Minocycline + AP n=70 Placebo + AP n=18 Placebo +

  41. Slide 41: SAM101 Reduces Negative Symptoms (Israel trial)

    SAM101 Reduces Negative Symptoms (Israel trial) Sanss Total NEGATIVE (SANS) 60 50 * * 40 No. 30 20 10 0 Week 1 (V1) Week 3 (V3) Week 9 (V6) Week 17 (V8) Week 25 (V10) Placebo Minocycline 20 POSITIVE (PANSS) 15 Score 10 5 0 -2 0 Base line Week 6 Week 14 Week 22 No difference in positive symptoms Mino

  42. Slide 42: SAM101 in Cognitive Functions (Israel trial)

    SAM101 in Cognitive Functions (Israel trial) 42

  43. Slide 43: SAM101 Improves General Function (Israel trial)

    SAM101 Improves General Function (Israel trial) 43

  44. Slide 44: SAM101 Prevents Weight Gain (Israel trial)

    SAM101 Prevents Weight Gain (Israel trial) 0.2 = 20% of patients 44

  45. Slide 45: Safety and Tolerability (Israel trial)

    Safety and Tolerability (Israel trial) Minocycline-related Adverse Events: Minocycline + atypical Two patients Two patients with antipsychotics suffered from mild pigmentation GIT symptoms Placebo + atypical none antipsychotics Minocycline + atypical antipsychotics Placebo + atypical antipsychotics

  46. Slide 46: SAM101 Reduces Negative Symptoms (Manchester trial)

    SAM101 Reduces Negative Symptoms (Manchester trial) PANSS NEGATIVE PANSS Negative 25 Baseline-1Y 20 * P<0.01 15 score 10 5 0 baseline 1 year Placebo Minocycline PANSS Positive POSITIVE (PANSS) 20 15 score 10 5 0 baseline 1 year No significant difference in positive symptoms Placebo Minocycline 46

  47. Slide 47: SAM101 Improves Cognitive Functions (Manchester trial)

    SAM101 Improves Cognitive Functions (Manchester trial) Stroop Word Color 140 Baseline-1Y 120 * P<0.03 100 score 80 60 40 20 0 baseline 1 year Placebo Minocycline Stroop Color 250 Baseline-1Y 200 P<0.07 150 score 100 50 0 baseline 1 year Placebo Minocycline 47

  48. Slide 48: Combination Therapy Reduces Weight Gain (Manchester trial)

    Combination Therapy Reduces Weight Gain (Manchester trial) 48

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