BioLineRx Company Presentation (Jun-14)

8/12/2019 BioLineRx Company Presentation (Jun-14)

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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-lookingstatements involve known and unknown risks anduncertainties that may cause the actual results, performanceor achievements of BioLineRx to be materially different fromany future results, performance or achievements expressed or

implied by such forward-looking statements.

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Forward Looking Statements


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BioLineRx - General

Founded in 2003 by Teva and other key players in Israeli LifeSciences industry

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 through to major catalyst

Partner the asset (depending on the stage)

For commercialization

For late-stage clinical development

For early and mid-stage co-development

Current pipeline of 10 assets, 6 in clinical development

Traded on both NASDAQ and TASE - symbol BLRX

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BioLineRxs Value Proposition

Multiple shots on goal

Several meaningful value inflection points in next 12 months

Two pharma assets regulated as devices

Strategic relationships and access to Israeli technology

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Our Proven Business Model

Identify promisingprojects

Conduct FeasibilityTesting`

Develop throughclinical stages

Partner

Strong scientific

basis

High chance ofregulatory approval

Competitiveadvantage

Strong IP

Validate results ofinventors

Resolve mainconcerns regardingtoxicity, CMC, etc.

Accelerateddevelopmentprogram

FDA/EMA standards

Continued clinicaldevelopment, ifneeded

Regulatory approval

Commercialization

5>2,000 assets screened; 45 entered development; 8 entered clinic; 4 partnered


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Efficient Project Development Infrastructure

BD

In-licensing andOut-licensing

Chemistry Team(Organic, Analytical,Bioanalytical,Formulation)

ExpertProject

Managers

Medical andClinical Team

Pre-ClinicalTeam

RegulatoryAffairs Team

IntellectualProperty Experts

MultipleProjects

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Main Pipeline Assets

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LEAD DEVELOPMENT PROGRAMS

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BL-8040:BEST-IN-CLASS CXCR4

ANTAGONIST FORTREATMENT OFHEMATOLOGICAL

CANCERS


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BL-8040 Highlights

Indications:Acute myeloid leukemia (AML) & other hematological cancers

Orphan designation received from FDA for both AML and stem-cell mobilization

Mode of Action:CXCR4 antagonism

CXCR4 over-expressed in >70% of tumors, and correlates with disease severity.

Status: Phase II trial ongoing

Product Highlights:

Induces apoptosis in cancer cells

Mobilizes cancer cells from bone marrow to peripheral blood

Sensitizes cancer cells to chemo- and bio-based anti-cancer therapy

Safety and mobilization activity demonstrated in Phase I/II study in myeloma patients

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AMLTreatment and Unmet Medical Need

AML is most common acute leukemia in adults

Over 60,000 new cases recorded worldwide in 2010, growing to 130,000 by 2020

14,000 cases of AML diagnosed in the US in 2012

Majority of AML patients relapse and require repeated treatment cycles

AML has poor prognosisless than 25% five-year survival

Over 10,000 fatalities from AML in the US in 2012

AML treatment regimens have changed little in past 30 years Treatment of AML is based largely on use of older chemotherapeutic drugs

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BL-8040 Mechanism Of Action

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Binds CXCR4 with high affinity (1-2 nM)

Maintains extended inhibition of CXCR4 through long receptor occupancy (>24 hours)

Works as inverse agonist of CXCR4

Induces apoptosis of tumor cells dependent on CXCR4 for survival

Increases sensitivity to anti-cancer agents by mobilizing tumor cells from protective

microenvironment

BL-8040

direct ly

inducesapoptosis

BL-8040

BL-8040

sensit izes

tumor c e l ls toother drugs

BL -8040 +

SoC

BL-8040

induces

tumor ce l lsmobi l izat ion

BL-

8040

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BL-8040 Superiority to Mozobil

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Time post BL-8040/Mozobil injection

NumberofNeutrophils

BL-8040 12 mg/kg

Mozobil 3.2 mg/kg

Mobilization

Cell Death


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Other Evidence of BL-8040s SuperiorAnti-Cancer Effect

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*

* Kuhne MR, Clinical Cancer Research, 2012

BL-8040 (formerly BKT140) inhibits proliferation of Ramos cells comparedwith Mozobil (AMD3100) and BMS-936564 (MDX-1338)

Study was conducted by scientists from BMS


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BL-8040

(BKT-140)

Mozobil

(Plerixafor/AMD3100)

BMS-936564

(MDX1338)Affinity with CXCR4 1-2 nM 84 nM 5nM

MOA Inverse agonist Antagonist (partial agonist) Antagonist

Binding siteExtracellular domains in theCXCR4 receptor

Trans-membrane regions inthe CXCR4 receptor

Extracellular domains in the CXCR4receptor

PK (T1/2 in human) 0.30.7 hr ~3-5 hr More than 24hr

Receptor occupancy More than 24 hr ~2 hr Not published

Inducing apoptosis intumor cells

Induces apoptosis in preclinicalmodels. Evidence of remarkableapoptosis in samples frompatients administrated with 0.75and 1 mg/kg (phase II).

NoneDemonstrated apoptosis inpreclinical models, modest effect inpatients (ASH 2013)

Mobilization ofLeukemic blasts

6-8 fold increase(6/8 patients, phase IIa)

2.5 fold(A phase I/II study, Blood2012)

2.1-fold increase(14/24 patients in phase II study,ASH 2013)

Other remarks of BL-8040: BL-8040 synergizes with Rituximab and Bendamustine to stimulate Lymphoma cell death in vitro. BL-8040 synergize with Bortezomib (Velcade) to stimulate MM cell death in vitro. Combination of BL-8040 with Imatinib in CML cells overcomes the protective effect of stroma in vitro. BL-8040 alone is highly efficient in eliminating lymphoma cells in the bone marrow and combined with Rituximab significantly

reduces tumor load (in vivo).

Summary of BL-8040 vs. Competitors

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BL-8040 PlatformClinical Development Program

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Pre-Clinical Phase I Phase II Phase III

INDICATIONPROTOCOL

Ongoing

Investigator-initiated study

Completed

Commence Q2/2014

R/R AMLBL-8040.01

CMLBL-8040.03

BL-8040.02

BKTSC001 MM SC MOBILIZATION

SINGLE AGENT SC MOBILIZATION

HEMATOLOGICAL MALIGNANCIES

STEM CELL MOBILIZATION


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Phase IIa - Treatment of r/r AML patients

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A phase IIa, mult icen ter, open-label study desig ned to evaluate safety and eff icacy

prof i le of repeated escalat ing do ses of BL -8040 in adul t sub jects with relapsed or

refractory acute myelo id leukemia

Study design:

Dose escalation phase3+3 design, up to 5 escalating doses (0.5-1.5 mg/kg)

Expansion phase: expand safe, efficacious dose group

Treatment:

2 consecutive days of BL-8040 monotherapy

5 days of BL-8040 + chemotherapy

Endpoints:

To assess the safety and tolerability of escalating repeated doses of BL-8040 as monotherapy and whencombined with high-dose Ara-C in AML adult subjects with relapsed or refractory disease

To assess the clinical efficacy (response rates) of escalating repeated doses of BL-8040

To assess the apoptotic effect of BL-8040 on leukemic blasts

To assess the effect of BL-8040 on mobilization of AML blasts to peripheral blood (PB)

To assess the single and multiple dose pharmacokinetic profile of BL-8040

Treatment Follow upScreening

BM biopsy

BL-8040

Day

Ara-C

1 2 3 4 5 6 7 ------------------------------------------------------------------------------ 30

BL-8040.01


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Partial Results in AML Phase II Study

Safe at all doses tested to date (0.5, 0.75 and 1mg/kg)

Substantial mobilization of cancer cells from BM to peripheral blood

Evidence for robust effect of cancer cell death

Completion of study expected in early 2015

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Peripheral bloodsample apoptosisassay


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Phase I - Single Agent Stem Cells Mobilization

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A phase I, two part study explor ing the safety, to lerabi l i ty , pharmaco dynam ic and

pharmacokinet ic ef fect of ascending dos es of BL-8040 in heal thy sub jects

expected to start in Q3 2014; results expected in late 2014 or early 2015Study design:

Part 1Dose escalation, randomized, placebo controlled - up to 4 escalating doses (0.5-1.25 mg/kg)

Part 2Dose expansion of safe and efficacious dose group

Treatment:

2 consecutive days of BL-8040 monotherapy

Endpoints:

Safety and tolerability of escalating repeated (2 days QD) doses of BL-8040 in healthy subjects.

Effect of BL-8040 on WBC total and differential counts in peripheral blood (PB).

Effect of BL-8040 on mobilization of hematopoietic stem cells (HSC) to peripheral blood (PB).

Pharmacokinetic profile of BL-8040.

To assess yields of hematopoietic progenitor cells, immune cells, and other cellular subsetscollected by leukapheresis (Part 2)

To assess the viability, biological activity and repopulating capacity of the cells collected byleukapheresis (Part 2)

Collection

Mobilization Safety follow up

Safety follow upMobilization

Screening

Screening

Part 1

Part 2

BL-8040

1-28Day 2 73

BL-8040.02


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BL-8040.03

Phase I/II study u sing the com binat ion o f Imat in ib and BL -8040 for impro ving

mo lecular respo nse in chronic m yelogenous leukemia (CML) pat ients in f i rs t chro nic

phase achieving less than op t imal response with Imat in ib

Study design:

Patients with chronic phase CML on Imatinib therapy achieving less than optimal response accordingto ELN criteria or less than MR4 after 24 months of Imatinib treatment

Dose escalation phase3+3 design, up to 4 escalating doses (0.5-1.25 mg/kg)

Expansion phase: expand safe, efficacious dose group

Treatment:

Daily Imatinib 400 mg/day throughout the study. Single s.c. BL-8040 injection on days 1, 15, 29 and 43, four hours prior to Imatinib.

Endpoints:

To assess the safety and tolerability of escalating repeated doses of BL-8040 when combined withImatinib in CML adult subjects with relapsed or refractory disease

To assess the clinical efficacy of BL-8040 in combination with Imatinib in achieving improvedcytogenetic and molecular response in CML patients.

To assess the anti tumor efficacy of BL-8040 in CML patients.

To assess the apoptotic effect of BL-8040 in combination with Imatinib on CML stem cells.

Phase I/IIa - Treatment of CML patients (investigator-initiated)

Daily Imatinib treatment Safety and efficacy follow up

-14 15 29 43Days 90 133

BM Biopsy

BL-8040

1

Screening


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BL-8040 Summary

CXCR4 is a validated target

BL-8040 has robust mobilization activity and apoptosis

Validated in preliminary data from Phase II study in AML, and Phase I/II study in multiplemyeloma

BL-8040 has very favorable profile in comparison with leading CXCR4 antagonists

BL-8040 is an inverse agonist

Blocks the auto-signaling of CXCR4

BL-8040 is a platform for a number of hematological indications

Additional studies in CML and stem-cell mobilization are about to start

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BL-7010:NOVEL GLIADIN

BINDING POLYMERFOR

CELIAC DISEASE


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BL-7010: Polymeric Binder for Celiac Disease

Indication: Celiac disease

Mode of Action: Non-absorbable polymer with high affinity to gliadins(immunogenic peptides contained in gluten)

Status: Phase I/II ongoing

Product Highlights

Prevents pathological damage to small intestine

Non-absorbable

Non-toxic

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Celiac DiseaseLarge Unmet Medical Need

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1% of worlds population suffers from celiac disease

Number underestimated due to lack of awareness/diagnostic tools

Market projected to reach $8 billion by 2019

No current pharmacological agents approved for celiac

Only treatment option is life-long, strict gluten-free diet (GFD)

~20% of celiac patients are symptomatic even with GFD

Major interest shown by Big Pharma

AbbVie recently acquired rights to phase II asset from Alvine for $70 million upfront


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BL-7010 Prevents Formation of GliadinsImmunogenic Peptides

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Small intestinal damage with loss ofabsorptive villi and hyperplasia of thecrypts, typically leading to malabsorption

BL-7010

Gluten

Gliadin

Enterocytes

Lymphocytes

Inflammatory Cytokines

APC

The polymer andgliadin are excretedin feces

Copolymer of sodiumstyrene sulfonate (SS)and 2-hydroxyethylmethacrylate (HEMA)

Gluten

BL-7010 demonstratesdistinguished specificitytowards gliadin

Prevention of intestinal damage


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BL-7010 Maintains Normal Structure of GI

non-sensitizedmice

Gluten-sensitizedmice

Gluten-sensitizedmice + BL-7010

5.96 1.23Villus-to-crypt ratio 2.58 0.43 4.89 1.51

Model: HLA-DQ8/HCD4 transgenic male mice sensitized to gliadin


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BL-7010 Clinical Program Overview

Two studies in celiac patients are planned in 2014:

Phase I/II study in celiac patients

Consist of 2 parts:

- Top-line results expected in mid-2014

Efficacy study in celiac patients expected to begin by end of year

6-week repeated oral administration

Efficacy endpoints (primary and secondary) and safety endpoints 27

Single ascending dose

Safety endpoints

No efficacy endpoints

Assessment of systemic exposure

14 days repeated administration

3 times per day

Safety w/o efficacy endpoints

Assessment of systemic exposure


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Partial Results - Ascending Dose Stage of Phase I/II Study

Single administration, dose escalation part of study completed

Study structure based on alternating group design; each subject receiving 3 different

single escalating doses of BL-7010 or placebo

Study remains blinded

Escalation reached highest planned dose

All planned doses found to be safe and well tolerated

No serious or dose-limiting adverse events reported

All subjects completed participation in study

Based on encouraging safety results, repeated administration

part of study will be initiated

Each subject to receive 3x daily dosing of BL-7010 or placebo for 14 days

PK samples have been collected for analysis and will be reported

at study completion, together with top-line results

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BL-7010 Summary

Celiac disease is a huge unmet medical need

There are only a handful of clinical-stage programs in development

BL-7010 has a unique MOA

High molecular weight polymers

High affinity to gluten

Secreted through feces

Currently in Phase 1/2 pilot study

No dose limiting toxicity in first part of study

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BL-1040:FIRST-IN-CLASS

MYOCARDIAL IMPLANTFOR PREVENTION OF

VENTRICULAR REMODELINGFOLLOWING AMI

Out- l icensed to Bel leropho n(f/k/a Ikaria) and bein g

developed as B ioabsorbable

Cardiac Matr ix (BCM)

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BL-1040 Highlights

Indication: Cardiac remodeling post-AMI

Mode of Action: Provides support to ischemic tissue during healing

Status: CE Mark registration trialcompletion expected in mid-2015

Device designation (including FDA)

Partnered with Bellerophon BCM (f/k/a Ikaria)

Total deal structure $282.5 million; $17 million already received; 11-15% royalties

All program costs funded by Bellerophon BCM

Market Opportunity: > Billion dollar market*

31*Based on a customized survey and report prepared for BioLineRx by Defined Health


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Unmet Medical Need

Vessel occlusion

Successfully treatedwith PCI and stents

Tissue damage

No sufficiently effectivetreatment for myocardial

damage

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How Does BL-1040 Work?

Infarct related artery injection

Deposits into infarcted tissue

Upon contact with infarcted tissue, turns from liquid into gel

Gel-like scaffold provides mechanical support to damaged tissue

Transitions to liquid and exits the body within 6 weeks

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BL-1040 Prevents Structural Changes

Normal sizeleft ventricle

Normal LV

wall

Dilated leftventricle

Thin LV wall

Untreated BL-1040

Porcine AMI model, day 60

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Promising Results from Pilot Study

Designated as device by regulatory authorities(including FDA)

Pilot study in Europecompleted January 2010

27 patients, safety and preliminary efficacy in patients withprimary MI at high risk for LV remodeling

9 sites: 6 in Germany, 3 in Belgium

Trial results show

No treatment related complications, arrhythmias, elevations incardiac enzymes or occlusions

Comparison to historical data suggests superior efficacy

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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 200 patients enrolled to date

Endpoints: End diastolic volume index, QLQ, six-minute walk test

Trial to be completed by mid-2015

US pivotal trial in planning stages

Final discussions with FDA

Placebo controlled, >1,000 patients, 12-month follow-up

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BL-1040 Summary

Huge unmet medical need

>$1 billion market

Designated as device in both US and Europe

Pilot study successfully completed

No safety or tolerability issues after six months of follow-up

Promising efficacy in comparison to historical data

CE mark registration study progressing at full steam

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CORPORATE

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Financial and Corporate Summary

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Available cash as of March 31, 2014 - ~$37.5 million

Funds operational capital through 2016

Expect to reach several value inflection points during this time

Number of employees45

Approximately 2/3 with advanced degrees

Capital structure (on basis of ADSs)

34.0 million outstandingbasic capital

40.0 million outstandingfully diluted capital

US investors ~60% of shareholder base


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Analyst Coverage

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BioLineRx Ltd. is followed by the analysts listed below:

Please note that any opinions, estimates or forecasts regarding BioLineRx Ltd.'s

performance made by these analysts are theirs alone and do not represent opinions,

forecasts or predictions of BioLineRx Ltd. or its management. BioLineRx Ltd. does not by

its reference above or distribution imply its endorsement of or concurrence with suchinformation, conclusions or recommendations.

Analyst Firm

Jason Kolbert Maxim Group

Joe Pantginis Roth Capital Partners, LLC

Raghuram Selvaraju Aegis Capital Corp.

Robin Davison; Jason Zhang Edison Investment Research


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2014

Major Milestones over next 12 Months

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BL-7010 (Celiac Disease) phase 1/2 completion

BL-7010 (Celiac Disease) CE pivotal study initiation

BL-1040 (AMI) CE mark study completion

BL-8040 (AML) phase 2 completion

BL-8040 (AML) phase 2 partial results*

BL-8040 (SC Mobilization) phase 1 initiation

BL-8040 (SC Mobilization) phase 1 completion

* End of dose escalation phase

2015

BL-1040 (AMI) complete CE mark study enrollment

BL-8040 (CML) phase 1/2 study initiationBL-7010 (Celiac Disease) pre-IND mtg with FDA


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Documents

BioLineRx Company Presentation (Jun-14)