Xtl Biopharmaceuticals Ltd. · TASE:XTLB
Xtl Biopharmaceuticals — Investor Presentation (January 2017)
27 slides from Xtl Biopharmaceuticals's investor presentation, January 2017
Slide 1: XTL Biopharmaceuticals
January 2017 XTL Biopharmaceuticals (NASDAQ: XTLB) (TASE: XTLB.TA) www.xtlbio.com
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimate
Slide 3: Highlights
Highlights Developing clinical assets for the treatment of autoimmune diseases Address large markets with high unmet clinical needs Well-defined clinical pathway and relatively quick time to market Partner with large Pharma to help fund late stage development Initial focus on hCDR1 asset f
Slide 4: Corporate Overview
Corporate Overview Lead product candidate (hCDR1 or Edratide): for treatment of autoimmune diseases Novel compound with unique mechanism of action Clinical data in >400 patients with Systemic Lupus Erythematosus (SLE) o Demonstrated favorable safety profile and well tolerated by patients o “De
Slide 5: hCDR1: Phase II Ready in Two Autoimmune Indications
hCDR1: Phase II Ready in Two Autoimmune Indications Peptide that down-regulates autoimmune processes Developed by Prof. Edna Mozes from Weizmann Institute of Science (Israel) >40 peer reviewed journal articles; >200 animal experiments Three clinical studies completed on hCDR1 treating over 4
Slide 6: hCDR1: Unique Mechanism of Action (MOA)
hCDR1: Unique Mechanism of Action (MOA) MOA of hCDR1: Different than existing late stage pipeline candidates Specific upstream immunomodulation through generation of regulatory T cells Unique MoA – potential as standalone therapy or in combination with other lupus drugs 6
Slide 7: hCDR1: Treatment of SLE/Lupus
hCDR1: Treatment of SLE/Lupus 7
Slide 8: SLE: Affected Organs & Symptoms
SLE: Affected Organs & Symptoms Chronic, debilitating inflammatory autoimmune disease Resulting in rheumatologic, dermatological and end-organ manifestations 8
Slide 9: SLE/Lupus: Market Overview
SLE/Lupus: Market Overview Prevalence1 1.5 million patients in U.S. (5 million worldwide) across various ethnicities/geographies Vast majority at onset are women / majority between ages of 15 and 45 Prognosis Dermatologic & musculoskeletal manifestations are the most common but major organ
Slide 10: SLE/Lupus: Competitive Landscape
SLE/Lupus: Competitive Landscape Current treatments: anti-malarials, corticosteroids, immunosuppressants, cytotoxics Problems with current treatments: severe side effects (hypertension, osteoporosis, bone marrow suppression, increased cancer risk, etc.) Benlysta (HGS/GSK): approved by FDA Marc
Slide 11: hCDR1 (Edratide): Clinical Trial History
hCDR1 (Edratide): Clinical Trial History Three clinical trials completed (by Teva): Phase Ia, Ib and IIb trials Over 400 patients enrolled in prior trials Well tolerated and demonstrated favorable safety profile Phase IIb (PRELUDE) trial (conducted by Teva) Did not meet primary endpoint (S
Slide 12: 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 12
Slide 13: 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 14: PRELUDE: Peer-Reviewed Publication (August 2015)
14 PRELUDE: Peer-Reviewed Publication (August 2015) Confidential 5-Jan-17
Slide 15: XTL Sponsored Trial: Improve Probability of Success
XTL Sponsored Trial: Improve Probability of Success Proposed trial design based on: (1) FDA written guidance; (2) Benlysta trials; and (3) clinical data from PRELUDE - especially the 0.5 mg results in BILAG endpoint PRELUDE Trial Proposed Trial Primary endpoint SLEDAI only BILAG Substantial Responde
Slide 16: hCDR1 for SLE: Development Milestones
hCDR1 for SLE: Development Milestones Milestone 2016 2017 2018 * Pre-IND Meeting √ * Finalize phase 2b trial design √ CMC – Drug Product production & testing √ * New Patent Applications filed √ Glossary IND of Terms Approval PRELUDE – name of Phase 2b trial performed by Teva on hCDR1 * IND – Enrollm
Slide 17: hCDR1: treatment of Sjögren's Syndrome (SS)
hCDR1: treatment of Sjӧgren’s Syndrome (SS) 17
Slide 18: SS: Affected Organs & Symptoms
SS: Affected Organs & Symptoms Chronic autoimmune inflammatory disorder characterized by diminished lacrimal and salivary gland function that may affect multiple organs/systems Two types of SS (~50/50): • Primary SS (pSS): SS patient who does not have another major rheumatic and/or autoimmune diseas
Slide 19: SS: Market Overview
SS: Market Overview Prevalence ~0.7%1 of U.S. population– estimated 2.5 to 4 million patients2 Vast majority at onset are women (at least 9:1)2 Average age at diagnosis: 40-50 years2 Market expected to grow to 3.5 million cases globally by 20241 Prognosis Hallmark symptoms are dry eyes
Slide 20: SS: Competitive Landscape
SS: Competitive Landscape No approved treatment for the systemic manifestations of the disease Two approved symptomatic treatments Salagen (pilocarpine; Eisai, 1998) and Evoxac (cevilemine; Daichi, 2000) Immunomodulatory treatments (usually for extra-glandular disease) Cyclosporine (ocular
Slide 21: hCDR1: Pre-clinical Study Data on pSS Patients
hCDR1: Pre-clinical Study Data on pSS Patients Blood mononuclear cells (PBMC) from blood samples of patients with pSS incubated in-vitro with hCDR1 and a control peptide Promising in-vitro/ex-vivo study results: Significant reduction in gene expression of 3 cytokines considered to be pathogeni
Slide 22: hCDR1: Upcoming (Phase 2) Study in pSS
hCDR1: Upcoming (Phase 2) Study in pSS Safety of hCDR1 in humans already established in SLE patients First clinical trial in pSS will be a controlled Phase 2 study Study objectives: Safety & efficacy of different doses of hCDR1 in pSS patients 3-arm study – 2 doses plus control Study durat
Slide 23: 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 24: Clinical Advisory Board
Clinical Advisory Board Dr. Daniel Wallace, Cedars-Sinai Medical Center; Largest lupus practice of its kind in the US Former Chairman of the Lupus Foundation of America (LFA), received LFA Award, Lupus Research Institute Achievement Award and others Professor David Isenberg, University College
Slide 25: Corporate Snapshot
Corporate Snapshot Headquarters: Raanana, Israel Member: Corporate Advisory Council of the Lupus Foundation of America ADRs trading on NASDAQ (XTLB) and Ordinary Shares on TASE (XTLB.TA) Capitalization (as of December 31, 2016): 274,205,799 Shares Outstanding* Warrants to purchase 961,11
Slide 26: Summary
Summary Lead candidate (hCDR1): for treatment of autoimmune diseases Novel compound with unique mechanism of action Ready for two Phase 2 studies in different autoimmiune indications Clinical data in > 400 SLE patients “Demonstrated efficacy in … clinically meaningful endpoints” Encourag
Slide 27: Thank You
Thank You www.xtlbio.com 27
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