BioLineRx (BLRX) 6-K Current report (foreign)

Exhibit 99.1

Company Presentation

February 2014

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 the actual results, performance
or achievements of BioLineRx to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statements.

2

Forward Looking Statements

Offering Summary

Issuer	BioLineRx Ltd.
Listing/Ticker	NASDAQ: BLRX
Offering Size	Approximately $20 million
Securities Offered	Common Stock (ADSs)
Expected Timing	March 4, 2014
Use of Proceeds	Continued clinical development of lead programs (BL- 8040 and BL-7010) and general corporate purposes
Book-runner	Roth Capital

BioLineRx - General

•Founded in 2003 by Teva and other key players in Israeli Life
Sciences 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 under symbol “BLRX”

4

BioLineRx’s Value Proposition

•Multiple shots on goal

•Several meaningful value inflection points in next 12 months

•Two assets in pivotal studies during next 12 months

•Two pharma assets regulated as devices

•Strategic relationships and access to Israeli technology

5

Our Proven 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
needed

•Regulatory approval

•Commercialization

6

>2,000 assets screened; 45 entered development; 8 entered clinic; 3 partnered

Efficient Project Development Infrastructure

BD

In-licensing and
Out-licensing

Chemistry Team

(Organic, Analytical,
Bioanalytical,
Formulation)

Expert
Project
Managers

Medical and
Clinical Team

Pre-Clinical
Team

Regulatory
Affairs Team

Intellectual
Property Experts

Multiple

Projects

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Main Pipeline Assets

8

LEAD DEVELOPMENT PROGRAMS

9

10

BL-8040:
BEST-IN-CLASS CXCR4
ANTAGONIST FOR
TREATMENT OF
HEMATOLOGICAL
CANCERS

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

11

AML - Treatment and Unmet Medical Need

•AML is most common acute leukemia in adults

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

–14,000 cases of AML diagnosed in the USin 2012

–Majority of AML patients relapse and require repeated treatment cycles

•AML has poor prognosis - less 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

•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

BL-8040 +
SoC

BL-8040

BL-
8040

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XIAP

Smac/DIABLO

HSP32

Claspin

BCL-2

BCL-X

Reference spot

Cytochrome C

CTRL

BL-8040

HSP70

HSP27

Treatment:

HIF1α

cIAP1

K562 cells (CML) were treated withBL-8040 (20 uM, 24h). Analyzed by WB.

•Down regulation of Bcl-X and Bcl-2 leads to activation of
BAX/BAK, and the activation of caspases.

•Down regulation of Bcl-2 regulates Cytochrome C and
Smac/DIABLO release from the mitochondria leading to
enhanced caspase activity by binding to IAPs.

CXCR4

Bak

Noxa

Active Bak/Bax

Caspase-9 activation

Caspase-3 cleavage

PARP cleavage

Bcl-X/Bcl-2

Smac/DIABLO

CytochromeC

XIAP/cIAP1

Apoptosis

BL-8040

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Current BL-8040 Phase II Study in AML

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•Study summary

–Open-label study under IND carried out at multiple centers in the US and Israel

–Relapsed or refractory AML patients (up to 50 patients)

•Study design

–Dose escalation phase - up to 5 escalating doses (0.5-1.5 mg/kg)

–Expansion phase of safe, efficacious dose group

•Endpoints

–Safety and tolerability

–Efficacy

–Clinical response based on bone marrow biopsy

–Proportion of AML blasts in peripheral blood and bone marrow

–Leukemic cell apoptosisin peripheral blood and bone marrow

BL-8040 AML Study Design

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Screening

BL-8040

BL-8040 + Chemotherapy [Cytarabine (ARA-C)]

Evaluation of response

1234567 ------------------------------------------------------------ 30

Day:

BM biopsy:

BM biopsy

•Completion of AML study expected end of 2014 / beginning of 2015

Partial Results in AML Study

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

•Substantial mobilization of cancer cellsfrom BM to peripheral blood

•Evidence for robust effect of cancer cell death

•Additional information on will be provided at end of dose escalation
stage - expected by mid-2014

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Peripheral blood
sample apoptosis
assay

BL-8040 Superiority to Mozobil

Time post BL-8040/Mozobil injection

BL-8040 12 mg/kg

Mozobil 3.2 mg/kg

CXCL12 serum levels

Time post BL-8040/Mozobil injection

BL-8040 0.11

BL-8040 0.167

BL-8040 0.22

Mozobil 0.11

Mozobil 0.167

Mozobil 0.22

Mobilization

Cell Death

Superiority of BL-8040’s Anti-Cancer Effect

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*

* Kuhne MR, Clinical Cancer Research, 2012

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

M. Abraham et al., Unpublished data

BL-8040 is Effective on FLT3 Mutated AML Cells (in-vitro)

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*p<0.05 vs. control

** p<0.05 vs. BL8040 alone

In-vitro effect of BL-8040 or AMD3100 -/+ ARA-C on viability of human AML cells with the FLT3 mutation

BL-8040 is Effective on FLT3 Mutated AML Cells (in-vivo)

Effect of BL-8040 in NSG mouse model with FLT3-mutated AML cells (MV4-11), in vivo

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•Results show:

–Multiple BL-8040 injections reduced number of AML cells in blood and BM

–Multiple BL-8040 injections induced apoptosis of AML cells in blood and BM

Day 7

Day 7

Blood

BM

Day 7

BL-8040 is Effective on FLT3 Mutated AML Cells in
comparison with AC220 (Quizartinib, Ambit)

•Results show:

–Similar efficacy of BL-8040 and AC220 (FLT-3 targeted therapy) in FLT3-mutated AML model

–Multiple BL-8040 injections reduced the number of AML cells in blood and BM

Number of AML cells within the BM

*

*

*p<0.05 vs. control

Effect of BL-8040 or AC220 in NSG mouse model with FLT3-mutated AML cells (MV4-11), in vivo

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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 site	Extracellular domains in the CXCR4 receptor	Trans-membrane regions in the CXCR4 receptor	Extracellular domains in the CXCR4 receptor
PK (T1/2 in human)	0.3 - 0.7 hr	~3-5 hr	More than 24hr
Receptor occupancy	More than 24 hr	~2 hr	Not published
Inducing apoptosis in tumor cells	Induces apoptosis in preclinical models. Evidence of remarkable apoptosis in samples from patients administrated with 0.75 and 1 mg/kg (phase II).	None	Demonstrated apoptosis in preclinical models, modest effect in patients (ASH 2013)
Mobilization of Leukemic blasts	6-8 fold increase (6/8 patients, phase IIa)	2.5 fold (A phase I/II study, Blood 2012)	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).

BL-8040 vs. Competitors

23

Additional Study Planned in Stem-Cell Mobilization

•Expected to start in H1 2014; results expected in H2 2014

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In-vivo results show that BL-8040 has significantly better stem
cell mobilization, as compared with G-CSF and Mozobil

25

BL-7010:NOVEL GLIADIN
BINDING POLYMER
FOR

CELIAC DISEASE

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 Disease - Large Unmet Medical Need

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•1% of world’s 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)

–~50% 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

Small intestinal damage with loss of
absorptive villi and hyperplasia of the
crypts, typically leading to malabsorption

BL-7010

Gluten

Gliadin

Enterocytes

Lymphocytes

Inflammatory Cytokines

APC

Copolymer of sodium
styrene sulfonate (SS)
and 2-hydroxyethyl
methacrylate (HEMA)

Gluten

BL-7010 demonstrates
distinguished specificity
towardsgliadin

Prevention of intestinal damage

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BL-7010 Maintains Normal Structure of GI

non-sensitized
mice

Gluten-sensitized
mice

Gluten-sensitized
mice + BL-7010

5.96 ± 1.23

Villus-to-crypt ratio

2.58 ± 0.43

4.89 ± 1.51

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

Preliminary ADME Shows BL-7010 is Excreted in Feces

•[3H]-BL-7010 was given orally to SD rats (single dose and single dose
after 21 days of dosing of non-labeled compound)

•Total urine and feces were collected from 0 to 12, 12 to 24, 24 to 36, 36
to 48 and 48 to 72 h after administration

•Blood was sampled at 30 min, 1, 2, 4, 8, 12, 24, 48 and 72 h and the
organs were collected (small intestine, colon, liver, kidneys and
spleen)

•Radioactivity in blood, urine, feces and organs was assessed

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BL-7010 Clinical Program Overview

Two studies in celiac disease patients are planned in 2014:

•Phase I/II study in celiac patients (ongoing)

–Single and repeated ascending dose study

–Safety endpoints, no efficacy endpoints

–Assessment of systemic exposure

–Top-line results expected in mid-2014

•Efficacy study in celiac patients

–6-week repeated oral administration

–Efficacy endpoints (primary and secondary) and safety endpoints

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BL-7010 Phase I/II Study in Celiac Patients

•Part 1: Single ascending administration phase (ongoing)

–Two alternating cohorts; 8 patients each (6 on BL-7010 and 2 on placebo)

–Up to 6 escalating administrations

–Population - well controlled celiac patients = absence of gastrointestinal
symptoms, with negative serology for transglutaminase 2 (TG2) and EMA
antibodies (IgA)

•Part 2: 14-day repeated administration phase

–One cohort; 8 patients (6 on BL-7010 and 2 on placebo)

–Option for adding an additional cohort with different quantity of BL-7010, based on
results of first repeated administration cohort

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ADDITIONAL SELECTED PROGRAMS

33

BL-1040:
FIRST-IN-CLASS
MYOCARDIAL IMPLANT
FOR PREVENTION OF
VENTRICULAR REMODELING
FOLLOWINGAMI

Out-licensed to Bellerophon
(f/k/a Ikaria) and being
developed as Bioabsorbable
Cardiac Matrix (BCM)

34

BL-1040 Highlights

•Indication: Cardiac remodeling post-AMI

•Mode of Action: Provides support to ischemic tissue during healing

•Status: CE Mark registration trial - results expected in 2014

•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*

35

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

Unmet Medical Need

Vessel occlusion

Tissue damage

36

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

37

BL-1040 Prevents Structural Changes

Normal size
left ventricle

Normal LV
wall

Dilated left
ventricle

Thin LV wall

Untreated

BL-1040

Porcine AMI model, day 60

38

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 results show

–No treatment related complications, arrhythmias, elevations in
cardiac enzymes or occlusions

–Comparison to historical data suggests superior efficacy

39

BL-1040 Pivotal Clinical Development Program

•Pivotal CE Mark Registration trial progressing at full steam

–~75 sites currently active in nine countries (including 15 sites in US)

–Placebo controlled, 306 patients, six-month follow-up

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

–Results expected in 2014

•US pivotal trial in planning stages

–Final discussions with FDA

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

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BL-5010:
A NOVEL FORMULATION
FOR NON-SURGICAL
REMOVAL OF SKIN
LESIONS, EMBEDDED
WITHIN NEW APPLICATOR
PEN (BL-5010P) - FOR
TOPICAL USE

BL-5010 Highlights

•Novel formulation for non-surgical removal of skin lesions

•Status: CE mark registration trial to commence in H1 2014

•Product Highlights:

–Medical device classification in EU

–Single application office-based treatment

–Pilot study completed with outstanding results

•~97% removal rate; 94% good/excellent cosmetic results

–State-of-the-art applicator (BL-5010P) developed for streamlined application

–Short time to market

42

BL-5010 Roadmap

43

•Pivotal CE Mark Registration study to commence in H1 2014

–Bridging study of BL-5010 pen-like applicator in seborrheic keratosis

–Regulatory submissions have been completed

–Study results are expected H2 2014

–Commence CE-mark registration process in H2 2014

•Clinical study in additional indication to commence in H214

•US market will be addressed following European approval

BIOLOGICS COLLABORATION

44

Biologics Collaboration with JHL Biotech

•Collaboration deal inked in January with JHL Biotech for BL-9020,
monoclonal antibody for treatment of Type 1 diabetes

–JHL responsible for manufacturing

–BioLineRx responsible for pre-clinical activities

–JHL receives commercialization rights in

China & South Asia

–Each party responsible for clinical development in its territory, with data sharing

•JHL Biotech is rising star in development and manufacturing of
biologics

–Top-tier shareholders, such as Kleiner Perkins and Sequoia Capital

–2 world-class manufacturing facilities, designed and built in partnership with GE Healthcare

•Collaboration forms basis for development of additional biologics

–Israel is outstanding source of biologic compounds (especially antibodies)

45

Anti insulin

NKp46-Ig

Merge

*

*Gur et al., Nature Immunology, 2010

CORPORATE

46

Financial Summary

47

•Available cash as of December 31, 2013 - ~$18.2 million

−Annual burn rate ~$12 million

−Cash expected to last into mid-2015

•Number of employees - 45

−Approximately 2/3 with advanced degrees

•Capital structure (on basis of ADSs)

−24.1 million outstanding - basic capital

−29.6 million outstanding - fully diluted capital

•Shareholder base approximately 50% US-based

Analyst Coverage

48

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 such
information, conclusions or recommendations.

Analyst	Firm
Robert Hazlett	Roth Capital Partners, LLC
Raghuram Selvaraju	Aegis Capital Corp.
Robin Davison; Jason Zhang	Edison Investment Research

2014 Major Milestones

BL-5010 (Skin Lesions) pivotal EU study initiation

BL-5010 (Skin Lesions) pivotal EU study results

BL-7010 (Celiac Disease) phase 1/2 top line results

BL-7010 (Celiac Disease) pivotal study initiation

BL-1040 (AMI) pivotal CE mark study results

BL-8040 (AML) phase 2 topline results

BL-9020 (Type 1 Diabetes) collaboration with JHL

√

BL-8040 (AML) phase 2 partial results*

BL-8040 (Stem Cell Mobilization) phase 1 initiation

BL-8040 (Stem Cell Mobilization) phase 1 results

* End of dose escalation phase

BL-7010 (Celiac Disease) phase 1/2 study update*

BL-5010 (Skin Lesions) additional study initiation

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