Xtl Biopharmaceuticals Ltd. · TASE:XTLB
Xtl Biopharmaceuticals — Investor Presentation (January 2014)
48 slides from Xtl Biopharmaceuticals's investor presentation, Jan 24, 2014
Slide 1: XTL Biopharmaceuticals
January 2014 www.xtlbio.com XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTL)
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 an
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 ▪
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: Com
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
Slide 6: Mid to Late Stage Focus: Ideal Investment Opportunity
Mid to Late Stage Focus: Ideal Investment Opportunity
Slide 7: Product Pipeline
Product Pipeline Biologic Agent! Therapeutic Area rug Compound Preclinical Phase! © Phasell Phasellb _Phase'lll SLE ‘Multiple Myeloma THUEPO Schizophrenia ‘SAM-101 XTLbio
Slide 8: hCDR1 for the treatment of Lupus
hCDR 1 for the treatment of Lupus
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
Slide 10: Lupus: Market Overview
Lupus: Market Overview ▪ Prevalence ▪ 1.5 million patients in the U.S. ( 5 million patients worldwide) 1 v a r ying 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
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.
Slide 12: hCDR1 for the treatment of Lupus
hCDR 1 for the treatment of Lupus hCDR 1 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 exclusiv
Slide 13: Animal Data: Beneficial Effects of hCDR1
(NZBxNZW)F 1 Lupus - prone mice 10 s.c. weekly injections with Edratide or control peptide (or just vehicle) BALB/c mice with induced Lupus Anti - dsDNA antibodies * p< 0.05 Proteinuria * p< 0.05 Animal Data: Beneficial Effects of hCDR 1 Immune complex deposits
Slide 14: Clinical Trial History of hCDR1
Clinical Trial History of hCDR 1 ▪ 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 prima
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
Slide 16: PRELUDE - Secondary Endpoint
Post - Hoc Post - Hoc Pre Defined 36 40 43 50 13 15 16 15 27 23 20 18 N= 88 N= 59 N= 169 OR (Odds Ratio) [95%CL] Value Lower Limit Upper Limit LR Test P-Value Comparison 0.5 mg vs Placebo 2.09 1.07 4.14 0.03 1 mg vs Placebo 1.85 0.94 3.68 0.07 2.5 mg vs Placebo 1.26 0.65 2.45 0.50 BILAG Complete Res
Slide 17: BILAG Responder Analysis at LOV Compared to Baseline
BILAG Responder Analysis at LOV Compared to Baseline (Placebo vs. Edratide 0.5 mg) PRELUDE - Secondary Endpoint (Pre - defined) n= 83 n= 76 Substantial effect even though steroid withdrawal was not enforced (see below)
Slide 18: BILAG Complete Responder Analysis
BILAG Complete Responder Analysis (Placebo vs. Edratide 0.5 mg) Subjects with BL Steroids < 20 mg daily dosage (n= 137 ) Subjects with no Steroids at BL (n= 29 ) PRELUDE - Secondary Endpoint (Post Hoc) n= 69 n= 68 n= 16 n= 13 Clear trend toward even more substantial effect with reduced steroid use
Slide 19: New Phase IIb Trial: To Improve Probability of Success
New Phase 2 b 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 Ster
Slide 20: rHuEPO for treatment of multiple myeloma (MM)
rHuEPO for treatment of multiple myeloma (MM)
Slide 21: Multiple Myeloma: 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 m edian survival is still: 4 - 5 years ▪ MM is the second most common hematological cancer ( 10 %) and about 1 % of all cancers ▪
Slide 22: 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: Melphalan; Cyclophosphamide; Doxorubicin, e
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
Slide 24: Clinical Trial History of rHuEPO for use with MM Patients
▪ Clinical observation on advanced MM patients treated with rHuEPO for anemia ( 1990 s; Prof. Mittelman) : ▪ Corrected the anemia (Hb rise) – known effect ▪ Reduced blood transfusion requirements ▪ Improved quality of life ▪ A novel biological effect: Patients lived 38 - 94 months longer than expect
Slide 25: rHuEPO for MM: Phase II 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
Slide 26: SAM-101 for treatment of schizophrenia
SAM - 101 for treatment of schizophrenia Schizophrenia networks in prefrontal cortex
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
Slide 28: 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 blood - brain barrier ▪ Neuro - prote
Slide 29: SAM-101: Addresses unmet needs
SAM - 101 : Addresses unmet needs Compliance improvement Treatment for partial responders Cognitive symptoms treatment Negative symptoms treatment Better side - effect profile SAM 101 was effective in treatment of acute, stabilized and treatment - resistant patients SAM 101 showed significant improv
Slide 30: SAM-101: Independent Clinical Studies
SAM - 101 : Independent Clinical Studies: Schizophrenia Patients Location # of pat. (C/R) Duration (months) Daily Dose (mino) Stage of disease Type of trial Study Endpoints Israel 21/54 6 200 mg O.D First episode - acute Double - blind, placebo - controlled Primary: negative Secondary: cognitive s
Slide 31: SAM-101: Independent Clinical Study Results
SAM - 101 : Independent Clinical Study Results Israeli Study Manchester Study Results Reduced Negative Symptoms (SANS): flattening, apathy, alogia , asociality , disturbance in attention : Reduced Negative Symptoms (PANSS Negative) flattening, apathy, alogia , asociality , disturbance in attention I
Slide 32: SAM-101: Potential for Phase 2b
▪ Ongoing market research is currently being conducted with KOLs (Defined Health) ▪ KOLs interviewed to date agree that SAM 101 promises to address a major unmet need in the treatment of schizophrenia ▪ Key points of KOL interest in the SAM - 101 program: ▪ MoA - combines anti - inflammatory and neu
Slide 33: Summary and Next Steps
Summary and Next Steps XTLbio
Slide 34: XTLbio – Next Steps
XTLbio – Next Steps 1 ▪ hCDR 1 : ▪ 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 F
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 cl
Slide 36: Thank you!
Thank you!
Slide 37: Backup Slides – hCDR1 for Lupus
Backup Slides – hCDR 1 for Lupus
Slide 38: 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 without improvement from A or B to C or D/E at LO
Slide 39: Backup Slides - SAM-101
Backup Slides - SAM 104 XTLbio
Slide 40: Israeli Phase IIa SAM-101 Study Design
Phase I – 3 w Stabilization Open phase Randomization Placebo + AP Minocycline + AP Screening Baseline Phase II – 24 w Continuation Double - blind Parameters Tested Primary: Negative (SANS) Secondary: Cognitive (CANTAB), Function, Positive (PANSS) Large - scale ( 54 randomized patients), prospective,
Slide 41: SAM-101 Reduces Negative Symptoms (Israel trial)
Sanss Total 0 10 20 30 40 50 60 Week 1 (V1) Week 3 (V3) Week 9 (V6) Week 17 (V8) Week 25 (V10) No. Placebo Minocycline * * SAM 101 Reduces Negative Symptoms (Israel trial) 0 5 10 15 20 -2 0 Base line Week 6 Week 14 Week 22 Score Minocycline+atypical antipsychotics Placebo+atypical antipsychotics NEG
Slide 42: SAM in Cognitive Functions (Israel trial)
SAM 101 in Cognitive Functions (Israel trial)
Slide 43: SAM Improves General Function (Israel trial)
SAM 101 Improves General Function (Israel trial)
Slide 44: SAM Prevents Weight Gain (Israel trial)
SAM 101 Prevents Weight Gain (Israel trial) 0.2 = 20 % of patients
Slide 45: Safety and Tolerability (Israel trial)
Safety and Tolerability (Israel trial) Minocycline - related Adverse Events: Two patients with mild pigmentation Two patients suffered from GIT symptoms Minocycline + atypical antipsychotics none Placebo + atypical antipsychotics Minocycline + atypical antipsychotics Placebo + atypical antipsychotic
Slide 46: SAM Reduces Negative Symptoms (Manchester trial)
SAM 101 Reduces Negative Symptoms (Manchester trial) POSITIVE (PANSS) No significant difference in positive symptoms PANSS Positive 0 5 10 15 20 baseline 1 year score Placebo Minocycline PANSS Negative 0 5 10 15 20 25 baseline 1 year score Placebo Minocycline PANSS NEGATIVE * Baseline - 1 Y P< 0.01
Slide 47: SAM Improves Cognitive Functions (Manchester trial)
SAM 101 Improves Cognitive Functions (Manchester trial) Stroop Word Color 0 20 40 60 80 100 120 140 baseline 1 year score Placebo Minocycline Stroop Color 0 50 100 150 200 250 baseline 1 year score Placebo Minocycline * Baseline - 1 Y P< 0.03 Baseline - 1 Y P< 0.07
Slide 48: Combination Therapy Reduces Weight Gain (Manchester trial)
Combination Therapy Reduces Weight Gain (Manchester trial)
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