Xtl Biopharmaceuticals Ltd. · TASE:XTLB
Xtl Biopharmaceuticals — IPO Roadshow (September 2014)
31 slides from Xtl Biopharmaceuticals's IPO roadshow presentation, Sep 26, 2014
Slide 1: XTL Biopharmaceuticals Issuer Free Writing Prospectus
September 2014 www.xtlbio.com XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTL) Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 194338 September 26 , 2014
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: Offering and registration statement notice
This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing in the ADSs. We have filed a registration statement (including a prospectus) with the United States Securities and
Slide 4: Offering Summary
Offering Summary Issuer XTL Biopharmaceuticals Ltd. Exchange: Ticker Nasdaq Capital Markets: XTLB Securities Offered American Depositary Shares (ADSs) Offering Size Approximately $4,000,000 of ADSs (100% Primary) Over - Allotment 15% (100% Primary) Use of Proceeds Use of proceeds will be concentra
Slide 5: Investment Proposition
Investment Proposition ▪ Focusing on the in - licensing and development of late - stage clinical assets to treat serious unmet medical needs in large markets ▪ Assets have a well - defined path, quick time to market ▪ Partner drug to big pharma after receipt of Phase II data ▪ Three assets in curren
Slide 6: Corporate Snapshot
Corporate Snapshot ▪ Headquarters: Herzliya Pituach , Israel ▪ ADRs trading on the NASDAQ (XTLB) and Ordinary Shares on the Tel - Aviv Stock Exchange (XTL) ▪ Cash (incl. Short Ter m Deposits): ~$ 3.2 m (as of 6 / 30 / 14 ) ▪ Capitalization (see Appendix): ▪ 231 , 772 , 624 Shares Outstanding* ▪ ~ 20
Slide 7: 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, Colb
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 r heumatologic, dermatological and end - organ manifestations
Slide 10: Lupus: Market Overview
Lupus: Market Overview ▪ Prevalence 1 ▪ 1.5 million patients in the U.S. ( 5 million patients worldwide) v a r ying across ethnicities and geographies ▪ 90 % are women / majority between ages of 15 and 45 ▪ Prognosis ▪ Dermatologic & musculoskeletal manifestation most common early on ▪ End organs be
Slide 11: 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 suppressi
Slide 12: hCDR1: General & Mechanism of Action
hCDR 1 : General & Mechanism of Action (MOA) hCDR 1 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
Slide 13: 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 trial ▪ Did not meet primary endpoin
Slide 14: PRELUDE (Phase II) Trial Design
PRELUDE (Phase II) Trial Design ▪ 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 Non - compliance with Steroid Withdrawal Phase not a protocol violation
Slide 15: BILAG Responder Analysis at LOV
BILAG Responder Analysis at LOV Compared to Baseline (Placebo vs. Edratide 0.5 mg) PRELUDE - Secondary Endpoint (Pre - defined/ITT Cohort) n= 83 n= 76 Substantial effect (p= 0.03 ) even though steroid withdrawal not enforced (see below)
Slide 16: BILAG Complete Responder Analysis
BILAG Complete Responder Analysis (Placebo vs. Edratide 0.5 mg) Subjects with BL Steroids < 20 mg daily dosage (n= 137 ; p= 0.007 ) Subjects with no Steroids at Baseline (n= 29 ; p= 0.05 ) PRELUDE - Secondary Endpoint (Post Hoc) n= 69 n= 68 n= 16 n= 13 Clear trend toward even more substantial effect
Slide 17: PRELUDE – Trends in other Secondary Endpoints
PRELUDE – Trends in other Secondary Endpoints * Predefined: an increase of ≥ 5 mg daily steroids compared to baseline ** Post Hoc: increase of ≥ 5 mg daily steroids vs. lowest previous dose SLE Responder Index* (Post Hoc/ITT Cohort) p= 0.058 Medicinal Flare Analysis (Post Hoc/ITT Cohort) p= 0.04
Slide 18: 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 Lupu
Slide 19: New Phase 2b Trial: Improve Probability of Success
New Phase 2 b 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 S
Slide 20: rHuEPO for the Treatment of Multiple Myeloma
rHuEPO for the 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 of ~ 5 years ▪ MM is the second most common hematological cancer ( 10 %) and about 1 % of all cancers ▪ In the U
Slide 22: 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 23: 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 ▪ A novel biological effect: Patients lived ~ 36 - 90 months longer than expected! ▪ Extensive clinical/basic research with human patients and m
Slide 24: rHuEPO for MM: Phase II 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
Slide 25: XTLbio – Next Steps
2014 2015 2016 XTLbio – Next Steps 1 hCDR 1 rHuEPO Finalize CAB/ Protocol Regulatory/ CMC Begin enrollment Phase II trial Complete Enrollment Phase II trial Interim data Phase II trial End of trial Begin enrollment Phase II trial Regulatory Complete Enrollment Phase II trial 1 Subject, in some ca
Slide 26: XTLbio – Summary
XTLbio – Summary ▪ XTL has three Phase II assets; current focus on two of the assets (hCDR 1 / rHuEPO ) ▪ Both address a significant unmet medical need ▪ Both have compelling clinical data ▪ hCDR 1 has robust data on > 400 patients on the FDA recommended endpoint ▪ rHuEPO for MM has shown significan
Slide 27: Appendix
Appendix
Slide 28: Summary Financial Outlook and Capitalization
Summary Financial Outlook $ 3.2 M in cash and short term deposits at June 30 , 2014 Capitalization Ordinary Shares Issued & Outstanding ( excluding ~ 4.4 m treasury shares) 231 , 772 , 624 Warrants Series 2 (until 10 / 28 / 14 @ $ 0.28 *) 12 , 217 , 106 Warrants Series B (until 3 / 17 / 15 @ $ 0.30
Slide 29: BILAG Responder Definition
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 LOV, and no de
Slide 30: SAM-101 for the Treatment of Schizophrenia
SAM - 101 for the Treatment of Schizophrenia Schizophrenia networks in prefrontal cortex
Slide 31: SAM-101 for Schizophrenia: Drug Overview
▪ SAM - 101 is a combination therapy: existing antipsychotic drug + minocycline ▪ Minocycline is a commonly prescribed anti - microbial and anti - inflammatory drug ▪ Effectively crosses the blood - brain barrier ▪ Neuro - protective activity in animal models of various neurodegenerative diseases ▪
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