Xtl Biopharmaceuticals Ltd. · TASE:XTLB
Xtl Biopharmaceuticals — Investor Presentation (September 2015)
20 slides from Xtl Biopharmaceuticals's investor presentation, Sep 10, 2015
Slide 1: XTL Biopharmaceuticals September 2015
September 2015 www.xtlbio.com XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTL)
Slide 2: Forward Looking Statements
Forward Looking Statements The following slides contain forward-looking statements, about XTL’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. Forward-looking statement
Slide 3: Introduction: What is XTL?
Introduction: What is XTL? • XTLbio is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of unmet clinical needs in large markets • Our lead drug is a “world-class” clinical asset: hCDR1 for treatment of SLE (lupus) • • SLE is a significant unme
Slide 4: Corporate Snapshot
Corporate Snapshot Headquarters: Raanana, Israel ADRs trading on the NASDAQ (XTLB) and Ordinary Shares on the Tel-Aviv Stock Exchange (XTL) Cash ≈ $4.8 million (as of 6/30/2015) In Q2 2015 raised $4 million from a large US healthcare fund and existing shareholders HC Wainwright research analyst init
Slide 5: 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 & MBA, CFO CFO, ZenithSolar; Finance Director, Colbar Lifescience (d
Slide 6: 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 Researc
Slide 7: hCDR1 for the treatment of Lupus
hCDR1 for the treatment of Lupus
Slide 8: SLE: General & Affected Organs & Symptoms
SLE: General & Affected Organs & Symptoms Systemic “Lupus” Erythematosus (SLE) is a chronic, debilitating inflammatory autoimmune disease, resulting in rheumatologic, dermatological and end-organ manifestations 8
Slide 9: Lupus: Market Overview
Lupus: Market Overview • Prevalence 1 1.5 million patients in U.S. (5 million worldwide) varying across ethnicities/geographies Vast majority are women / majority between ages of 15 and 45 • Prognosis Dermatologic & musculoskeletal manifestation most common early on End organs become involved as dis
Slide 10: 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 11: hCDR1: Unique Mechanism of Action (MOA)
hCDR1: Unique 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 Weizma
Slide 12: Clinical Trial History of hCDR1
Clinical Trial History of hCDR1 • Three clinical trials completed (by Teva): Phase Ia, Ib trials and a Phase II 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 primary endpoint (SLED
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) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% SOC + {Placebo n=83 SOC + Edratide 0.5 mg n=76 Substantial Responder Partial Responder Non-Responders Substantical effec
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) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% SOC + {Placebo n=83 SOC + Edratide 0.
Slide 15: PRELUDE – Trends in other Secondary Endpoints
PRELUDE – Trends in other Secondary Endpoints Medicinal Flare Analysis (Post Hoc/ITT Cohort) p=0.04 SLE Responder Index* (Post Hoc/ITT Cohort) p=0.058 40% 35% 30% 25% 20% 15% 10% 5% 0% 0.5 mg Edratide Placebo Predefined Medicinal Flare* Post-hoc Medincal Flare** Predefined: an increase of ≥ 5mg dail
Slide 16: PRELUDE: Recent Peer-Reviewed Article (8/15)
16 PRELUDE: Recent Peer-Reviewed Article (8/15) Confidential 8-Sep-15
Slide 17: New Trial (2b or 2/3): Improve Probability of Success
New Trial (2b or 2/3): 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 Trial Primary endpoint Dose Steroid Use Trial dura
Slide 18: hCDR1 Development Milestones
hCDR1 Development Milestones Milestone 2015 2016 2017 Publish PRELUDE Study Results ã CMC . Drug Substance ã Pre - IND Meeting CMC . Drug Product IND Trial Enrollment Interim Analysis * * * activity complete 18
Slide 19: Summary
Summary • hCDR1 for SLE has potential to be “first in class” and “best in class” drug • hCDR1 has a unique mechanism of action SLE is a significant unmet medical need; has shown high interest from Big Pharma There is no current effective solution on the market There is a very weak competitive pipeli
Slide 20: Thank You
Thank You 20
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