SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of April 2013
_______________________
BioLineRx Ltd.
(Translation of Registrant’s name into English)
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P.O. Box 45158
19 Hartum Street
Jerusalem 9777518 Israel
(Address of Principal Executive Offices)
_______________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F þ Form 40-F o
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
Yes o No þ
Attached as Exhibit 1 is a new corporate presentation, an abridged version of which will be presented by Registrant’s management at the Needham Healthcare Conference in New York later today.
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the Company under the Securities Act of 1933.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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BioLineRx Ltd.
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/s/ Philip Serlin
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Philip Serlin
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Chief Financial and Operating Officer
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Dated: April 30, 2013
Exhibit 1
Company Presentation
April/May 2013
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.
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
BioLineRx Highlights
• 7 clinical stage assets in variety of indications, 2 in advanced
clinical stages
clinical stages
• Broad pre-clinical pipeline - providing multiple opportunities
for next generation clinical projects
for next generation clinical projects
• Special strategic relationships and access to Israeli technology
• Strong balance sheet - $28 million cash as of March 31, 2013
• Several meaningful value inflection points in 2013 and 2014
3
OVERVIEW AND BUSINESS MODEL
4
Our Business Model
• Strong scientific
basis
basis
• High chance of
regulatory approval
regulatory approval
• Competitive
advantage
advantage
• Strong IP
• Validate results of
inventors
inventors
• Resolve main
concerns regarding
toxicity, CMC, etc.
concerns regarding
toxicity, CMC, etc.
• Accelerated
development
program
development
program
• FDA/EMA standards
• Continued clinical
development
development
• Regulatory approval
• Commercialization
5
Our Project Infrastructure Support
BD
In-licensing and
Out-licensing
Out-licensing
Expert
Project
Managers
Project
Managers
Medical and
Clinical Team
Clinical Team
Pre-Clinical
Team
Team
Multiple
Projects
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Current Pipeline
7
SELECTED PROGRAMS
8
BL-1020:
FIRST-IN-CLASS
GABA-ENHANCED
ANTI-PSYCHOTIC FOR
SCHIZOPHRENIA
FIRST-IN-CLASS
GABA-ENHANCED
ANTI-PSYCHOTIC FOR
SCHIZOPHRENIA
9
BL-1020 - Status Update and Next Steps
• Phase II/III CLARITY study interim analysis results were
announced on March 20
announced on March 20
– Primary and secondary cognition endpoints would not be reached with any
reasonable number of patients in CLARITY study
reasonable number of patients in CLARITY study
– Several statistical parameters specified in the statistical analysis plan (SAP)
indicated positive trends (e.g., social cognition, consistent timing)
indicated positive trends (e.g., social cognition, consistent timing)
• Currently in process of discontinuing CLARITY study
– Data-cleaning process should be completed by end of May
• Waiting to receive full analysis of un-blinded study data on all
study patients
study patients
– Full analysis should be finalized in the next few months
– At that point Company will make final decision about future of project
10
BL-1040:
FIRST-IN-CLASS
MYOCARDIAL IMPLANT
FOR PREVENTION OF
VENTRICULAR REMODELING
FOLLOWING AMI
FIRST-IN-CLASS
MYOCARDIAL IMPLANT
FOR PREVENTION OF
VENTRICULAR REMODELING
FOLLOWING AMI
Out-licensed to Ikaria Inc.
and being developed as
Bioabsorbable Cardiac Matrix
(BCM)
Bioabsorbable Cardiac Matrix
(BCM)
11
BL-1040 Highlights
• Indication: Cardiac remodeling post-AMI
• Mode of Action: Provides support to ischemic tissue during healing
• Status: CE Mark registration trial - conducted by Ikaria Inc.
• Product highlights:
• Resorbable polymer solution administered via intracoronary injection during standard
vessel reopening procedures
vessel reopening procedures
• Deposits in ischemic tissue and forms a “scaffold” that supports the injured tissue
during recovery
during recovery
• Regulated as a device
• Market Opportunity: > Billion dollar market*
12
*Based on a customized survey and report prepared for BioLineRx by Defined Health
Current Treatment Methodologies and Unmet
Medical Need
Medical Need
Vessel occlusion
Tissue damage
13
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 muscle
scaffold providing mechanical support to damaged cardiac muscle
Resorption occurs within 6 weeks;
dissolved BL-1040 excreted through the kidneys
dissolved BL-1040 excreted through the kidneys
14
BL-1040 Prevents Structural Changes
Following AMI
Following AMI
Normal size
left ventricle
left ventricle
Normal LV
wall
wall
Dilated left
ventricle
ventricle
Thin LV wall
Untreated
BL-1040
Porcine AMI model, day 60
15
BL-1040 Safe and Well-Tolerated in Phase I/II
Clinical Trial Results
Clinical Trial Results
• Clinical program based on extensive
interaction with FDA (CDRH division)
interaction with FDA (CDRH division)
• Pilot study in Europe - completed January
2010
2010
– 27 patients, safety and preliminary efficacy in
patients with primary MI at high risk for LV
remodeling
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
elevations in cardiac enzymes or occlusions
– Independent Safety Monitoring Board determined
BL-1040 is safe and that continued clinical
development appropriate
BL-1040 is safe and that continued clinical
development appropriate
Ikaria BL-1040 Out-Licensing Transaction
• Ikaria - proven expertise in drug and medical device
development and singular focus on acute care
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 milestones
– 11-15% sales royalties
– Territories: Worldwide
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BL-1040 Clinical Development Program
• Current development program includes two pivotal trials
– CE Mark Registration trial for European approval
– Second pivotal trial for US approval
• Pivotal CE Mark Registration trial currently progressing at full steam
– Multiple sites currently active in six countries (US, Australia, Canada, Belgium, Israel and
Spain)
Spain)
– Overall design:
• Placebo controlled
• 306 patients
• Six-month follow-up
– Endpoints:
• Left ventricular end diastolic volume
• Anatomic measurement of left ventricular end diastolic volume (echocardiogram)
• Quality of Life questionnaire
• Six-minute walk test
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BL-1040 Clinical Development Program (cont.)
• Second pivotal trial for US approval in planning stages
− Final discussions with FDA
− Overall design:
• 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
A NOVEL FORMULATION
FOR NON-SURGICAL
REMOVAL OF SKIN
LESIONS, EMBEDDED
WITHIN NEW APPLICATOR
PEN (BL-5010P) - FOR
TOPICAL USE
BL-5010 Highlights
• Positioning: Novel formulation for non surgical removal of
variety of skin lesions
variety of skin lesions
• Status: Pilot study completed in benign lesions (60 pts)
• Product Highlights:
– Single application office-based treatment
– State-of-the-art applicator developed for streamlined application
– Pilot study completed successfully
– 96.7% complete lesion removal
– 94% reported good to excellent cosmetic outcomes
– Medical device classification in EU
– Short time to market
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Treatment Profile Comparison
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BL-5010
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Cryotherapy
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Laser
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Electro-
Desiccation |
Surgery
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PDT
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Speed of
treatment |
Quick
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Very Quick
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Medium
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Slow
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Slow
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Slow
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Efficacy
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Very high
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High
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High
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Very high
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Very High
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High
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Pain
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Minimal
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Moderately Painful
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Mod. Painful
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Mod. Painful
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Painful
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Yes
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Scarring
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Minimal
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Hypopigmentation
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None
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Some
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Significant
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None
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Application in
sensitive areas |
Yes
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No
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Yes
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No
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Yes
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Yes
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Applicable for
large lesions |
Discrete lesions
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No
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No
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No
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Yes
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Yes
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Histology
compatible |
Yes
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No
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No
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No
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Yes
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No
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Set-up time
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Quick
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Quick
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Significant
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Lengthy
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Lengthy
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Lengthy
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Cost
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Low
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Very Low
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High
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Medium
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Medium
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High
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BL-5010 Phase I/II Clinical Trial Overview
• Open-label, single-arm, safety and efficacy study
• 60 patients with seborrheic keratosis investigated for BL-5010
single application safety and efficacy
single application safety and efficacy
• Patients treated and followed-up for 6 months
• Conducted in Germany and Holland
• Endpoints:
– Safety, efficacy (complete removal of lesion), cosmetic outcome
– Feasibility of histological analysis
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BL-5010 Phase I/II Clinical Trial Results
• Safety
– BL-5010 has a good safety profile - no persistent irreversible adverse
effects were observed at treated site
effects were observed at treated site
• Efficacy
– Lesion removal - lesions fell off by Day 30 in >96% of patients
– Cosmetic outcome
– 94.6% of investigator-assessed cosmetic outcomes and 84% of patient-assessed
cosmetic outcomes were good or excellent 180 days following treatment
cosmetic outcomes were good or excellent 180 days following treatment
– Demonstrated feasibility for BL-5010’s ability to preserve lesion structure for
subsequent histological diagnosis
subsequent histological diagnosis
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Representative Before and After Pictures
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BL-5010P - A Novel Applicator Pen for Topical Use
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• Distribution accuracy on target tissue
• Volume consistency
• Single patient use with potential to treat multiple lesions
• Allows application of pressure
• Ready for use
• Easy to use
• Hand-held device
• Aesthetic and ergonomic design
• Straightforward and low cost manufacturing
• Patentability of the applicator
• Disposable
BL-5010: Summary and Current Status
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• BL-5010 designated as a medical device in Europe
• Pilot safety and efficacy study successfully completed in
seborrheic keratosis patients
seborrheic keratosis patients
• Pivotal CE Mark Registration study to commence in H213
– Bridging study of BL-5010 pen-like applicator in seborrheic keratosis
– Pivotal study results are expected mid-2014
• Additional clinical study to commence in Q114
– Clinical trial using BL-5010 pen-like applicator in actinic keratosis
– Study results are expected late 2014 / early 2015
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BL-7040:
ORALLY AVAILABLE
TLR-9 AGONIST FOR
TREATMENT OF
INFLAMMATORY
BOWEL DISEASE
ORALLY AVAILABLE
TLR-9 AGONIST FOR
TREATMENT OF
INFLAMMATORY
BOWEL DISEASE
BL-7040 Highlights
• Indication: Inflammatory bowel disease (IBD)
• Mode of Action: Toll-Like Receptor 9 (TLR-9) modulator/agonist
• Status: Phase IIa proof-of-concept study completed
• Product Highlights:
– Orally available synthetic oligodeoxynucleotide (2nd generation)
– Oligo sequence was chemically modified (2’OMe) to increase stability
– Efficacy demonstrated in animal models of IBD - comparable to dexamethasone
– Efficacy, safety and tolerability demonstrated in clinical trials
• Market opportunity: ~$8 billion in 2012 (Datamonitor)
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IBD Overview
• A group of inflammatory conditions of the colon and small
intestine
intestine
• Two major types:
– Ulcerative colitis (UC): limited to the colon
– Crohn’s disease (CD): involves multiple segments of the gastrointestinal tract
• Common end pathway for both types consists of inflammation
of the intestinal tract mucosal lining
of the intestinal tract mucosal lining
• Causes ulceration, edema, bleeding, fluid and electrolyte loss
• ~2.6 million people affected by IBD (1.7M UC; 0.9M Crohn’s)
across seven major markets in 2011 (Datamonitor)
across seven major markets in 2011 (Datamonitor)
– Expected to reach 2.9 million by 2019
30
BL-7040 Pre-Clinical Efficacy Data
• BL-7040 significantly reduced colitis
severity in levels comparable to
Dexamethasone in -vivo
severity in levels comparable to
Dexamethasone in -vivo
• BL-7040 reduced LPS induced cytokine
secretion in intestinal explants
secretion in intestinal explants
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BL-7040
BL-7040
+ LPS
Study design:
1.Colitis induced in Balb/c mice using TNBS
2.Mice were administered BL-7040 orally for 7
days, starting 24h or 48h post colitis induction
days, starting 24h or 48h post colitis induction
3.Disease severity and anti-inflammatory
effects were assessed using the Wallach score
and IL secretion profile
effects were assessed using the Wallach score
and IL secretion profile
BL-7040 is as Effective as Dexamethasone in Treating Established IBD
Response Rates in Representative Studies
of Moderate to Severe UC
of Moderate to Severe UC
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Budesonide MMX (corticosteroid)/Mesalamine (5-ASA) - oral
• Clinical response (8-week treatment): 25% (placebo) versus ~33%% study drug
• Mucosal Healing (8-week treatment): 33% (placebo) versus ~40% study drug
Adalimumab (Humira)* - subcutaneously anti-TNF
• Clinical response (8-week treatment): 35% (placebo) versus 50% study drug
• Mucosal Healing (8-week treatment): 32% (placebo) versus 41% study drug
Golimumab (Simponi) - subcutaneously anti-TNF
• Clinical response (6-week treatment): 30% (placebo) versus 52% study drug
• Mucosal Healing (6-week treatment): 29% (placebo) versus 43% study drug
Infliximab (Remicade) - intravenously anti-TNF
• Clinical response (8-week treatment): 29-37% (placebo) versus 64-69% study drug
• Mucosal Healing (8-week treatment): 30-34% (placebo) versus 60-62% study drug
* In open-label Phase IIa trial of 20 UC patients, study drug showed clinical response rate of ~25%
BL-7040 Phase IIa Study Design
33
• General
– Open-label study to evaluate efficacy, pharmacodynamics, safety and tolerability
– Up to 30 patients with moderately active ulcerative colitis
• Recruitment and Treatment
– 22 patients enrolled in the study
– 6 patients discontinued and were not included in the statistical analysis.
– Statistical analysis was performed on the 16 patients that completed 5 weeks of
treatment (last day of treatment measurements were compared to baseline)
treatment (last day of treatment measurements were compared to baseline)
Main Endpoints of Study
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Met Primary - at least a 3-point decrease and 30%
reduction from baseline in Mayo score, plus a ≥ 1-point
decrease in rectal bleeding sub-score or an absolute
rectal bleeding sub-score of ≤ 1
reduction from baseline in Mayo score, plus a ≥ 1-point
decrease in rectal bleeding sub-score or an absolute
rectal bleeding sub-score of ≤ 1
2-point reduction - at least a 2-point decrease from
baseline in Mayo score
baseline in Mayo score
1-point reduction - at least a 1-point decrease from
baseline in Mayo score
baseline in Mayo score
50%
56%
75%
Primary Endpoint - Mayo Score
(end of treatment)
(end of treatment)
Change in Rectal Bleeding
(RB) from Baseline
(RB) from Baseline
* Note - 6 of these 9 patients (67%) demonstrated complete
remission in rectal bleeding
remission in rectal bleeding
*
Summary of BL-7040 Phase IIa Results
• Efficacy
– Primary clinical endpoint in study - reduction in Mayo score between baseline
and completion of treatment - was achieved.
and completion of treatment - was achieved.
• 50% of patients (8 patients) met primary endpoint; remaining 8 patients demonstrated
stable clinical condition or minor improvement.
stable clinical condition or minor improvement.
• 56% of patients (9 patients) demonstrated decreases of at least 1 point in the rectal-
bleeding sub-score; 69% (11 patients) had rectal-bleeding sub-scores of ≤1
bleeding sub-score; 69% (11 patients) had rectal-bleeding sub-scores of ≤1
• In 6 of the 11 patients, no rectal bleeding was seen at all
– 50% of patients completing study treatment also met certain secondary
endpoints, such as partial Mayo score reduction and mucosal healing
endpoints, such as partial Mayo score reduction and mucosal healing
• Safety
– BL-7040 was highly safe and well tolerated by the study participants
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36
BL-8040:
BEST-IN-CLASS CXCR4
ANTAGONIST FOR
TREATMENT OF
HEMATOLOGICAL
CANCERS
BEST-IN-CLASS CXCR4
ANTAGONIST FOR
TREATMENT OF
HEMATOLOGICAL
CANCERS
BL-8040 Highlights
• 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 development
• Product Highlights:
– Peptide
– Activity against various cancer types has been demonstrated in broad range of in vitro
and in vivo studies
and in vivo studies
• Induction of apoptosis in cancer cells
• Sensitization of cancer cells to chemo- and bio-based anti-cancer therapy
• Mobilization of stem cells from bone marrow
– Safety profile and mobilization activity demonstrated in Phase I/II study in myeloma
patients
patients
37
BL-8040 Mobilization Compared with Mozobil
38
• BL-8040 affords superior mobilization of neutrophils and progenitor cells
• Mobilization superiority correlates with CXCL12 levels in the blood
Time post BL-8040/Mozobil injection
BL-8040 12 mg/kg
Mozobil 3.2 mg/kg
Time post BL-8040/Mozobil injection
BL-8040 12mg/kg
Mozobil 3.2mg/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
• BL-8040, in contrast to Mozobil, exerts potent cytotoxicity against human leukemia
and myeloma cells in-vitro in a dose-dependent manner
and myeloma cells in-vitro in a dose-dependent manner
BL-8040 Anti-Cancer Activity Compared with Mozobil
BL-8040 Inhibits Tumor Growth in Mouse
Xenograft Leukemia (NB4) Model
Xenograft Leukemia (NB4) Model
Upcoming BL-8040 Phase II Study in AML
41
• Study summary
– Multicenter, open-label study, carried out at multiple centers in US and Israel
– Adult subjects (aged 18-70) with relapsed or refractory AML
• Study design
– Up to 50 patients
– Dose escalation phase - up to 5 escalating doses (0.5-1.5 mg/kg)
– Expansion phase of safe, efficacious dose group
• Treatment protocol
– 2 days of BL-8040 mono-therapy
– 5 days of BL-8040 + Cytarabine 1.5-3g/m2 (ARA-C)
• Endpoints
– Safety and tolerability
– Efficacy
• Rate and magnitude of response
• Proportion of AML blasts in peripheral blood and bone marrow
• Leukemic cell apoptosis in peripheral blood and bone marrow
BL-8040 AML Study Design
42
• Study expected to initiate in Q2 2013
− Regulatory approval in US already received
• Partial safety, tolerability and efficacy results expected by end of 2013
• Full results expected in 2014
Screening
BL-8040
BL-8040 + Chemotherapy
Evaluation of response
1 2 3 4 5 6 7 ------------------------------------------------------------ 30
Day:
BM biopsy:
BM biopsy
43
BL-8020:
ORAL, SYNERGISTIC
TREATMENT FOR
HCV
ORAL, SYNERGISTIC
TREATMENT FOR
HCV
BL-8020 Highlights
• Mode of Action: Inhibition of HCV-induced autophagy
• Status: Phase I/II
• Product highlights:
– Unique mechanism of action - inhibition of HCV-induced autophagy, a process
essential for viral replication
essential for viral replication
– Has demonstrated synergy with various other anti-HCV agents of different types
– Targets host and is therefore pan-genotypic
– Notable safety and efficacy - combination of HCQ & RBV; therefore, long-term safety
has already been demonstrated in humans
has already been demonstrated in humans
– Estimated market positioning - will potentially replace RBV, both in current regimens
and in future anti-HCV treatments
and in future anti-HCV treatments
44
Pre-Clinical Data
• In-vitro studies demonstrated synergistic effect with a number
of HCV therapies
of HCV therapies
• Ex-vivo analysis
– Uninfected human liver slices were infected with HCV and cultured up to 10 days
– At day 4 post-infection, liver slices were treated for 6 days with HCQ at different
concentrations, with and without RBV
concentrations, with and without RBV
– Antiviral activity of HCQ showed time and dose-dependent inhibitory effects on
HCV replication
HCV replication
45
Ex-Vivo Results
46
HCQ
RBV
The antiviral activity of HCQ showed time and dose-dependent inhibitory effects
on HCV replication
on HCV replication
HCQ and Ribavirin - Synergetic Effect
47
HCQ+RBV 1µM
HCQ+RBV 10µM
HCQ+RBV 20µM
HCQ+RBV 50µM
• Open-label study to evaluate efficacy, safety and tolerability of ribavirin mono-
therapy, followed by a combined treatment with Ribavirin and HCQ
therapy, followed by a combined treatment with Ribavirin and HCQ
• Study conducted at two leading sites in France
– Regulatory approval received in March 2013; FPI announced in April 2013
• Study population to include non-responders (null or partial ) or relapsed
patients
patients
• Partial results expected Q413; full results H114
Period 1
Ribavirin
(weight based dosage, BID)
Period 2
Ribavirin (Weight based, BID) + 575mg HCQ (QD)
Secondary
endpoint
endpoint
Primary
endpoint
endpoint
Screening
Week 8*
Week 24*
Study Design:
BL-8020: Upcoming Phase I/II Clinical Trial
48
Week 20*
* Viral load reduction testing performed
CORPORATE
49
Financial Summary
50
• Available cash as of March 31, 2013 - ~$28 million
− Annual burn rate between $12-14 million
− Cash expected to last into 2015
• Number of employees - 43
• Capital structure (on basis of ADSs)
− 22.3 million outstanding - basic capital
− 27.8 million outstanding - fully diluted capital (incl. warrants and stock options)
• Shareholder profile:
− Public - 67%
− Orbimed - 12%
− Pan Atlantic Investment Fund - 10%
− Teva Pharmaceuticals - 5%
− Ayer Capital Partners - 5%
− Other - 1%
Analyst Coverage
51
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.
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.
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Analyst
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Firm
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Raghuram Selvaraju
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Aegis Capital Corp.
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Steven Tepper
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Harel Finance
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Robert Hazlett
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Roth Capital Partners, LLC
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2013-14 Anticipated Clinical Milestones
52
2013
2014
