XTL Biopharmaceuticals Ltd. · TASE:XTLB
XTL Biopharmaceuticals — Investor Presentation (December 2014)
26 slides from XTL Biopharmaceuticals's investor presentation, December 2014
Slide 1: XTL Biopharmaceuticals
December 2014 XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTL) www.xtlbio.com
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
Slide 3: Investment Proposition
Investment Proposition 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 receipt of Phase II data Three assets in current deve
Slide 4: Corporate Snapshot
Corporate Snapshot Headquarters: Herzliya Pituach, Israel ADRs trading on the NASDAQ (XTLB) and Ordinary Shares on the Tel-Aviv Stock Exchange (XTL) Cash (incl. Short Term Deposits): ~$2.9 m (as of 9/30/14) Capitalization (see Appendix): 231,772,624 Shares Outstanding* ~20 million warran
Slide 5: Management Team Experience
Management Team Experience 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 Lif
Slide 6: hCDR1 for the treatment of Lupus
hCDR1 for the treatment of Lupus 6
Slide 7: Systemic Lupus Erythematosus (SLE)
Systemic “Lupus” Erythematosus (SLE) Lupus is a chronic, debilitating inflammatory autoimmune disease, resulting in rheumatologic, dermatological and end-organ manifestations 7
Slide 8: Lupus: Market Overview
Lupus: Market Overview Prevalence1 1.5 million patients in the U.S. (5 million patients worldwide) varying across ethnicities and geographies 90% are women / majority between ages of 15 and 45 Prognosis Dermatologic & musculoskeletal manifestation most common early on End organs become i
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
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
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
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 12
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
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
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
Slide 16: Clinically Advisory Board
Clinically 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 R
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
Slide 18: rHuEPO for the Treatment of Multiple Myeloma (MM)
rHuEPO for the Treatment of Multiple Myeloma (MM) 18
Slide 19: 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 of ~5 years MM is the second most common hematological cancer (10%) and about 1% of all cancers In the US there
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
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 (1990s; Prof. Mittelman): Corrected the anemia (Hb rise) – known effect A novel biological effect: Patients lived ~36-90 months longer than expected! Extensiv
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
Slide 23: XTLbio – Next Steps
XTLbio – Next Steps1 Finalize CAB/ Regulatory/ Begin enrollment Complete Enrollment Interim data hCDR1 Protocol CMC Phase II trial Phase II trial Phase II trial 2014 2015 2016 rHuEPO Regulatory Begin enrollment Complete Enrollment Phase II trial Phase II trial 1 Subject, in some cases, to necessary
Slide 24: XTLbio – Summary
XTLbio – Summary XTL has three Phase II assets; current focus on two of the assets (hCDR1/rHuEPO) Both address a significant unmet medical need Both have compelling clinical data hCDR1 has robust data on >400 patients on the FDA recommended endpoint rHuEPO for MM has shown significant surv
Slide 25: Appendix
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Slide 26: PRELUDE Secondary Endpoint: BILAG Responders
PRELUDE Secondary Endpoint: BILAG Responders 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 improvem
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