Biolinerx Ltd. · TASE:BLRX
Biolinerx — Investor Breakfast at TASE (December 2014)
44 slides from Biolinerx's conference presentation, Dec 24, 2014
Slide 1: Company Presentation: Investor Breakfast at TASE
Company Presentation Investor Breakfast at TASE December 25, 2014
Slide 2: 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 uncertainties that may cause
Slide 3: BioLineRx Snapshot
BioLineRx Snapshot • Drug development company with core focus on oncology and immunology • Bridge “development gap” for Israeli assets – Leverage carefully selected early-stage technology, primarily at academia level, following proof of concept in animals (at a minimum) – Invest 3-6 years in asset t
Slide 4: Our Business Model
Our Business Model • Strong scientific basis • High chance of regulatory approval • Competitive advantage • Strong IP • Validate results of inventors • Resolve main concerns regarding toxicity, CMC, etc. • Accelerated development program • FDA/EMA standards • Continued clinical development, if neede
Slide 5: Multiple High-Value Shots on Goal
Multiple High-Value Shots on Goal
Slide 6: Lead Programs
LEAD PROGRAMS
Slide 7: BL-8040: Best-in-class CXCR4 antagonist for hematological cancers
BL-8040: BEST-IN-CLASS CXCR4 ANTAGONIST FOR TREATMENT OF HEMATOLOGICAL CANCERS
Slide 8: BL-8040 Highlights
BL- 8040 BL-8040 + SoC BL-8040 BL-8040 Highlights • Indications: Acute myeloid leukemia (AML) & other hematological cancers • Mode of Action: CXCR4 antagonism – CXCR4 over-expressed in >70% of tumors, and correlates with disease severity. • Status: – Phase II trial ongoing (AML) – Phase I trial ongo
Slide 9: Projected Clinical Program Targets Several Hematological Indications
PROTOCOL INDICATION Ph2a - Ongoing - Topline results Q1/2015 Ph1/2 - Planned - Q2/2015-Q2/2017 Ph1/2 - Completed Ph1 - Ongoing - Q1/2015 Ph2b - Planned - Q1/2015-Q3/2017 Ph1/2 - Planned - Q1/2015-Q3/2016 Phase I Phase II Phase III BL-8040.01 hMDS and Aplastic Anemia BL-8040.06 BL-8040.02 BKTSC001 SC
Slide 10: On-going Studies
ON-GOING STUDIES rr AML & Stem Cell Mobilization
Slide 11: Results from r/r AML Phase 2a (under IND)
Results from r/r AML Phase 2a (under IND) • First four cohorts were completed • There were no BL-8040 related SAEs and none of the AEs were considered DLTs • Robust leukemic blast mobilization was observed (median of 6-fold increase) • BL-8040 monotherapy decreased amount of leukemic cells in BM by
Slide 12: BL-8040.01 Currently Taking Place in Multiple Leading Medical Centers
BL-8040.01 Currently Taking Place in Multiple Leading Medical Centers in the US and Israel Dr. Arnon Nagler Dr. Yishai Ofran Dr. Nadav Sarid Dr. James Foran Dr. Martin Tallman Dr. Jessica Altman Dr. Gautam Borthakur Dr. Dina Ben-Yehuda Dr. Jacob Rowe
Slide 13: Phase 1 - Single Agent Stem Cell Mobilization
Phase 1 - Single Agent Stem Cell Mobilization Study design • Part 1 - Dose escalation, randomized, placebo controlled - up to 4 escalating doses • Part 2 - Dose expansion of safe and efficacious dose group Timelines • Topline results expected by end of Q1/2015 Mobilization Safety follow up Safety fo
Slide 14: New Indications
3 NEW INDICATIONS
Slide 15: New Studies will be Initiated in 2015
3 New Studies will be Initiated in 2015 • AML Consolidation – Collaboration with the German Study Alliance Leukemia Group – Double blind, placebo controlled, repeated administrations, multiple treatment cycles – Sample size - ~200 patients – 20-25 sites in Germany – Topline results expected by Q4/20
Slide 16: MDS & Aplastic Anemia (AA)
• MDS and AA are hematological disorders characterized by bone marrow dysplasia, ineffective hematopoiesis and cytopenias • Effect of BL-8040 on BM regeneration: – Both pre-clinical and clinical signs of efficacy (from the on-going study) MDS & Aplastic Anemia (AA) RBC Hemoglobin
Slide 17: Major BL-8040 Development Milestones (Next Years)
Major BL-8040 Development Milestones (Next 3 Years) BL-8040 (hMDS) study completion BL-8040 (AML) phase 2 completion BL-8040 (AML) phase 2 partial results BL-8040 (SC Mobilization) phase 1 completion BL-8040 (hMDS & AA) FPI BL-8040 (FLT-3) study completion BL-8040 (Consolidation) FPI BL-8040 (FLT-3)
Slide 18: BL-1040: First-in-class myocardial implant
BL-1040: FIRST-IN-CLASS MYOCARDIAL IMPLANT FOR PREVENTION OF VENTRICULAR REMODELING FOLLOWING AMI Out-licensed to Bellerophon (f/k/a Ikaria) and being developed as Bioabsorbable Cardiac Matrix (BCM)
Slide 19: BL-1040 Highlights
BL-1040 Highlights • Indication: Cardiac damage following heart attack • Mode of Action : Provides structural support during healing • Status: EU registration trial - completion expected in mid-2015 • Device designation (including FDA) • Partnered with Bellerophon BCM (f/k/a Ikaria) – $282.5 million
Slide 20: Unmet Medical Need
Unmet Medical Need Vessel occlusion Tissue damage
Slide 21: How Does BL-1040 Work?
Porcine AMI model, day 60 L V L V How Does BL-1040 Work? Arterial injection deposits material into infarcted tissue Turns from liquid to gel on contact Gel-like scaffold provides mechanical support to damaged tissue Transitions back to liquid and exits the body within 6 weeks BL-1040 Untreated L V •
Slide 22: Promising Results from Pilot Study
Promising Results from Pilot Study • Designated as device by regulatory authorities (including FDA) • Pilot study in Europe - completed January 2010 – 27 patients, safety and preliminary efficacy in patients with primary MI at high risk for LV remodeling • 9 sites: 6 in Germany, 3 in Belgium • Trial
Slide 23: BL-1040 Pivotal Clinical Development Program
BL-1040 Pivotal Clinical Development Program • Pivotal CE Mark Registration trial progressing at full steam – Placebo controlled, total enrollment ~300 patients, six-month follow-up – ~80 sites currently active in nine countries (including 14 sites in US) – Over 280 patients enrolled to date – Endpo
Slide 24: BL-7010: Novel gliadin-binding polymer for celiac disease
BL-7010: NOVEL GLIADIN-BINDING POLYMER FOR CELIAC DISEASE
Slide 25: BL-7010: Polymeric Binder for Celiac Disease
BL-7010: Polymeric Binder for Celiac Disease • Indication: Celiac disease (harmful immune response to gluten) • Mode of Action: Novel polymer that binds to gluten peptides; prevents interaction with the immune system in the GI • Status: Phase 1/2 study completed in celiac patients • Product Highligh
Slide 26: Celiac Disease - Large Unmet Medical Need
Celiac Disease - Large Unmet Medical Need • 1% of world’s population suffers from celiac disease – Underestimated due to lack of awareness/diagnostic tools • Market projected to reach $8 billion by 2019 • No current therapies approved for celiac – Only treatment option is life-long, strict gluten-fr
Slide 27: BL-7010 mechanism of action
Copolymer of sodium styrene sulfonate (SS) and 2-hydroxyethyl methacrylate (HEMA) Gluten BL-7010 demonstrates distinguished specificity towards gliadin Prevention of intestinal damage Small intestinal damage leading to malabsorption BL-7010 Gluten Gliadin Cells in the intestinal wall Immune Cells In
Slide 28: BL-7010 Pre-clinical & Clinical Success to Date
BL-7010 Pre-clinical & Clinical Success to Date • Phase 1/2 safety study completed in celiac patients • Positive results presented in early November – Safe and well tolerated; no serious or dose-limiting side effects – Optimal dose identified: 1 gram x 3 per day – Confirmed no systemic absorption; s
Slide 29: Business Development Achievements
BUSINESS DEVELOPMENT ACHIEVEMENTS
Slide 30: Major Business Development Activities in Last Years
Major Business Development Activities in Last 2 Years • BL-8030 (HCV) out-licensed to CTTQ (Chinese leader for liver diseases) • BL-9020 (type I diabetes) collaboration with JHL • BL-5010 (skin lesions) out-licensed to Omega Pharma – Leading European OTC healthcare company with operations in 35 coun
Slide 31: Facts about Novartis
Facts about Novartis • Second largest pharma company worldwide, Market cap ~$225B – Expected to become the #1 in ethical drug sales by 2020 (by Decision Resources) • 135,000 employees • 2013 annual sales of ~$58B – Approximately $46.5B is estimated from ethical drugs • Sales growth rate: 2-4% – Ethi
Slide 32: Novartis Partnership
NOVARTIS PARTNERSHIP Overview
Slide 33: What is Background and Rationale for the Deal?
What is Background and Rationale for the Deal? • The key objectives of such a partnership are: – Increase likelihood of future licensing transaction – Reduce cost and risk of drug development, especially in clinical stages – Increase likelihood of success by incorporating inputs from industry leader
Slide 34: Specifics of Deal
• $10m at >20% premium • Represents 12.8% of BLRX equity • No Board seat/presence • Joint committee established to routinely evaluate projects • Only Israel-originated projects are reviewed • BLRX existing portfolio is NOT included in this partnership • If Novartis passes on a project, BLRX has full
Slide 35: Co-Development Principles
Co-Development Principles • Companies will agree on: – Endpoints for development (typically around Phase 1b or Phase 2a) – Development plan – Budget • Novartis will provide the following financing: – $5M “option fee” at time of signing (non-dilutive) – 50% of the remaining development budget via equ
Slide 36: How do we Protect BLRX Shareholder Interests?
How do we Protect BLRX Shareholder Interests? • Equity investment by a leading and sophisticated partner – Clear limitations in place on Novartis’ ability to sell shares in the future • Corporate governance is very strong – No board seat for Novartis – No rights to know about additional partnering d
Slide 37: How does Deal Meet our Strategic Objectives?
How does Deal Meet our Strategic Objectives? √ Increases likelihood of future licensing transaction √ Reduces cost & risk of development, especially in clinical stages √ Increases likelihood of success by incorporating inputs from industry leader √ Validates BLRX’s capabilities in identifying and de
Slide 38: Out-licensing of BL-5010 to Omega
OUT-LICENSING OF BL-5010 TO OMEGA
Slide 39: Deal Overview
Deal Overview • Omega Pharma Facts – Leader in OTC market in Europe, with over €1.3B in annual sales – Recently bought by Perrigo for €3.6B – Omega has existing products in leading relevant categories • Deal scope: – Geography: Europe, Australia and other selected countries – OTC uses only – BLRX ma
Slide 40: Deal Implications
Deal Implications • Additional validation of BioLineRx’s business model – Develop early-stage Israeli projects until advanced clinical stages – Identifying leading relevant partners for commercialization of these projects • Value creation from non-core projects as well – Potential for relatively nea
Slide 41: Corporate
CORPORATE
Slide 42: Financial and Corporate Summary
Financial and Corporate Summary Strong cash position • $29.6 million as of September 30, 2014 (latest financials) – Does not include $10 million received from Novartis • Current resources fund operational capital through end of 2016 • Expect to reach several value inflection points during this time
Slide 43: Major Development Milestones - 2014 and 2015
Major Development Milestones - 2014 and 2015 BL-7010 (Celiac Disease) CE pivotal study initiation BL-8040 (AML) phase 2 partial results* BL-8040 (SC Mobilization) phase 1 completion * End of dose escalation phase BL-1040 (AMI) complete CE mark study enrollment BL-7010 (Celiac Disease) phase 1/2 comp
Slide 44: BioLineRx
BIOLINEM ><
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