Biolinerx Ltd. · TASE:BLRX
Biolinerx — Investor Presentation (January 2013)
37 slides from Biolinerx's investor presentation, January 2013
Slide 1: Company Presentation
Company Presentation January 2013
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains "forward-looking statements." These statements include words like "may," "expects," "believes," “plans,” “scheduled," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and u
Slide 3: BioLineRx Highlights
BioLineRx Highlights • 6 clinical stage assets, 2 in advanced clinical stages for large market indications • Broad pre-clinical pipeline – providing multiple opportunities for next generation clinical projects • Special strategic relationships and access to Israeli technology • Unique government-spo
Slide 4: Our Business Model
Our Business Model Identify promising Conduct Feasibility Develop through Partner projects Testing` human POC • Strong scientific • Validate results of • Accelerated basis • Continued clinical inventors development development • High chance of program • Resolve main • Regulatory approval regulatory
Slide 5: Our Project Infrastructure Support
Our Project Infrastructure Support Expert Medical and Project Clinical Team Managers BD In-licensing and Pre-Clinical Out-licensing Team Multiple Projects Chemistry Team (Organic, Analytical, Intellectual Bioanalytical, Property Experts Formulation) Regulatory Affairs Team 5
Slide 6: Current Pipeline
Current Pipeline Pre-Ciinical Phase | Phase II Indication BL-1020 Schizophrenia Out-licensed to Cypress Bioscience in 2010; reacquired rights in 2011 BL-1040 AMI Qut-licensed to Ikaria Holdings Inc. following completion of Phase I/Il BL-5010 ‘Skin lesions BL-7040 Inflammatory bowel disease (IBD) BL-
Slide 7: BL-1020: First-in-Class GABA-Enhanced Anti-Psychotic for Schizophrenia
BL-1020: FIRST- IN- CLASS GABA-ENHANCED ANTI-PSYCHOTIC FOR SCHIZOPHRENIA 7
Slide 8: BL-1020 First In Class GABA Enhanced Anti-Psychotic
BL-1020 First In Class GABA Enhanced Anti- Psychotic • Indication: Schizophrenia; Cognitive Improvement in Schizophrenia (CIS) • Mode of Action: – Dopamine antagonism – GABAergic activity (associated with improved cognition) • Status: Phase II/III • Product Highlights: – First drug to show cognitive
Slide 9: Schizophrenia Market and Unmet Medical Need
Schizophrenia Market and Unmet Medical Need • Chronic, severe, and disabling brain disorder affecting ~1% of the U.S. adult population (National Institute of Mental Health) • Antipsychotic market estimated at $14 billion in US alone – Projected to stay stable through 2018 (DataMonitor) • Cognitive i
Slide 10: Phase 2b EAGLE Trial (Completed Sep 2009)
Phase 2b EAGLE Trial (Completed Sep 2009) Efficacy, safety and tolerability of BL-1020 in hospitalized patients with acute exacerbation of schizophrenia Main Trial Extension Trial BL-1020 BL-1020 10 mg/day 10 mg/day BL-1020 BL-1020 20-30 mg/day 20-30 mg/day Risperidone Risperidone 2-8 mg/day 2-8 mg/
Slide 11: Evidence for BL-1020's Pro-Cognitive Effects in EAGLE Trial
Evidence for BL-1020's Pro-Cognitive Effects in EAGLE Trial * BL-1020 BL-1020 Risperidone Placebo 10mg 20-30mg C BLOB 11
Slide 12: LS Mean Change of BACS Subscores
Improvement Demonstrated on all BACS Subscales Change in BACS Subscores from Baseline to Week 6 14 LS Mean Change of BACS Subscores 12 (Age - Gender -Corrected) BL-1020 10 mg 10 BL-1020 20-30 mg 8 Risperidone Placebo 6 4 2 0 Verbal Memory Digit Sequency Token Motor Verbal Fluency Symbol Coding Tower
Slide 13: CLARITY Phase II/III Trial (Commenced June 11)
CLARITY Phase II/III Trial (Commenced June 11) Acute and chronic antipsychotic and cognitive efficacy, safety and tolerability of BL-1020 compared with Risperidone Acute Chronic Phase Phase BL-1020 Titrate to MTD (15-35) BL-1020 Risperidone Titrate to MTD (2-6) Risperidone Up to 450 patients Primary
Slide 14: BL-1040: First-in-Class Myocardial Implant
BL-1040: FIRST-IN-CLASS MYOCARDIAL IMPLANT FOR PREVENTION OF CARDIAC REMODELING FOLLOWING AMI Out-licensed to Ikaria Inc. and being developed as Bioabsorbable Cardiac Matrix (BCM) 14
Slide 15: BL-1040: First-In-Class Myocardial Implant for Prevention of Cardiac Remodeling Following AMI
BL-1040: First-In-Class Myocardial Implant for Prevention of Cardiac Remodeling Following AMI • Indication: Cardiac remodeling • Mode of Action: Provides support to ischemic tissue during healing • Status: CE Mark registration trial - conducted by Ikaria Inc. • Product highlights: • Resorbable polym
Slide 16: Current Treatment Methodologies and Unmet Medical Need
Current Treatment Methodologies and Unmet Medical Need Vessel occlusion Tissue damage Successfully treated with PCI and stents No sufficiently effective treatment for myocardial damage 16
Slide 17: How Does BL-1040 Work?
How Does BL-1040 Work? Infarct related artery (intra-vascular) injection Deposition into infarcted tissue Liquid to gel phase transition upon contact with infarcted tissue Phase transition at infarct area creates resorbable bioprosthetic scaffold providing mechanical support to damaged cardiac muscl
Slide 18: BL-1040 Deposits in Damaged Tissue Following Intra-Coronary Injection
BL-1040 Deposits in Damaged Tissue Following Intra-Coronary Injection Targeting mechanism: 1. Injection occurs in the infarct related artery 2. Capillary bed compromised secondary to ischemia allows inflow of BL-1040 3. Physiological condition of ischemic region enables liquid to gel transition BL-1
Slide 19: BL-1040 Prevents Structural Changes Following AMI
BL-1040 Prevents Structural Changes Following AMI Porcine AMI model, day 60 Dilated left Normal size ventricle left ventricle Normal LV Thin LV wall wall Untreated BL-1040 19
Slide 20: BL-1040 Safe and Well-Tolerated in Phase I/II Clinical Trial Results
BL-1040 Safe and Well-Tolerated in Phase I/II Clinical Trial Results • Clinical program based on extensive interaction with FDA (CDRH division) • Pilot study in Europe – completed January 2010 – 27 patients, safety and preliminary efficacy in patients with primary MI at high risk for LV remodeling •
Slide 21: Ikaria BL-1040 Out-Licensing Transaction
Ikaria BL-1040 Out-Licensing Transaction • Ikaria - proven expertise in drug and medical device development and singular focus on acute care • Terms: √ $7 million upfront √ $10 million first milestone – ~$115 million in additional regulatory and developmental milestones – ~$150 million in commercial
Slide 22: BL-1040 Active Trial Program: Current Status and Next Steps
BL-1040 Active Trial Program: Current Status and Next Steps Two pivotal trials: CE Mark Registration trial Second Pivotal trial for US approval − Trial commenced − Final discussions with FDA − Overall design: − Overall design: • Placebo controlled • Placebo controlled • 306 patients • >1,000 patient
Slide 23: BL-8040, a Novel CXCR4 Antagonist for AML and Other Hematological Cancers
BL-8040, A NOVEL CCR4 ANTAGONIST FOR THE TREATMENT OF AML AND OTHER HEMATOLOGICAL CANCERS 23
Slide 24: BL-8040: Novel CXCR4 Antagonist For AML and Other Hematological Cancers
BL-8040: Novel CXCR4 Antagonist For AML and Other Hematological Cancers • Indications: AML & other hematological cancers • Mode of Action: CXCR4 antagonism – CXCR4 over-expressed in >70% of tumors, and correlates with disease severity. • Status: Phase II ready • Product Highlights: – Peptide – Activ
Slide 25: BL-8040 Mobilization Compared with Mozobil
BL-8040 Mobilization Compared with Mozobil • BL-8040 affords superior mobilization of neutrophils and progenitor cells • Mobilization superiority correlates with CXCL12 levels in the blood BL-8040 12 mg/kg Number of Neutrophils Mozobil 3.2 mg/kg Time post BL-8040/Mozobil injection CXCL12 serum level
Slide 26: BL-8040 Anti-Cancer Activity Compared with Mozobil
BL-8040 Anti-Cancer Activity Compared with Mozobil • BL-8040, in contrast to Mozobil, exerts potent cytotoxicity against human leukemia and myeloma cells in-vitro in a dose-dependent manner 120 NB4 HL60 120 NB4 HL60 (% of control) 100 (% of control) 100 Viable cells Viable cells 80 80 60 60 40 40 20
Slide 27: BL-8040 Inhibits Tumor Growth in Mouse Xenograft Leukemia (NB4) Model
BL-8040 Inhibits Tumor Growth in Mouse Xenograft Leukemia (NB4) Model I II Tumor size (cm2) 2.4 Ctrl 2.4 2 2 weight (g) BL-8040 200 1.6 1.6 1.2 1.2 ** 0.8 0.8 0.4 0.4 0 0 0 4 8 12 16 20 24 28 ctrl BL-8040 Time (days) DAPI TUNEL III x200 x200 Ctrl x200 x200 BL-8040 27
Slide 28: Proposed BL-8040 AML Study
Proposed BL-8040 AML Study A Phase 2, Multicenter, Open-label Study Designed to Evaluate Safety and Efficacy Profile of Repeated Escalating Doses of BL-8040 in Adult Subjects with Relapsed or Refractory Acute Myeloid Leukemia • Study design – Relapsed or Refractory AML, aged 18-70 – Up to 50 patient
Slide 29: BL-8040 AML Study Design
BL-8040 AML Study Design Relapse Treatment Follow Up BM biopsy: Day: 1 2 3 4 5 6 7 ------------------------------------------------------------ 31 Screening BL-8040 BL-8040 + Chemotherapy Evaluation of response BM biopsy • Study is expected to initiate in Q2 2013 • Preliminary safety, tolerability a
Slide 30: Other Main Programs
OTHER MAIN PROGRAMS 30
Slide 31: BioLineRx's Other Main Programs
BioLineRx’s Other Main Programs • BL-7040 for inflammatory bowel disease – Successfully completed Phase I study – Phase II ongoing, results expected Q1 2013 • BL-5010 for non-surgical removal of skin lesions – Successfully completed Phase I/II study – European regulatory classification as medical de
Slide 32: Corporate
CORPORATE 32
Slide 33: Unique Funding Programs
Unique Funding Programs BioLine Innovations Jerusalem • Only Israeli biotech incubator supported by Office of Chief Scientist, Israeli Trade Ministry (OCS) – $13 million received, plus additional $5 million under regular OCS funding track – Enhanced financial support, up to 85% of first $2 million o
Slide 34: Financial Summary
Financial Summary • Available cash as of September 30, 2012 - ~$26 million − Annual burn rate between $15-18 million − Cash expected to last into Q1 2014 (w/o additional funding or revenues) • Number of employees - ~50 • Capital structure (on basis of ADSs) − 18.4 million outstanding – basic capital
Slide 35: Analyst Coverage
Analyst Coverage BioLineRx Ltd. is followed by the analysts listed below: Analyst Firm Raghuram Selvaraju Aegis Capital Corp. Steven Tepper Harel Finance Robert Hazlett Roth Capital Partners, LLC Please note that any opinions, estimates or forecasts regarding BioLineRx Ltd.'s performance made by the
Slide 36: Near Future Company Milestones
Near Future Company Milestones BL-1020 - Schizophrenia BL-8040 – Hematological Cancers • Interim results in Q1 2013 • Start of Phase IIa trial Q1/Q2 2013 • Final results expected H2 2013 • Interim results expected 2013 • Partnering transaction BL-5010 – Skin Lesions BL-1040 – Cardiac remodeling • Fi
Slide 37: Bench1o Bedoideto Patner
Bench1o Bedoideto Patner BIOLINEM ><