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BioLineRx Ltd.

Foreign Filer Report Jun 12, 2017

6692_rns_2017-06-12_669e482b-23f9-4889-b0d7-be0147dd2a69.pdf

Foreign Filer Report

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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 June 2017_______________________

BioLineRx Ltd.

(Translation of registrant's name into English)_______________________

2 HaMa'ayan Street Modi'in 7177871, 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-FForm 40-F

_______________________

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:

YesNo ☑ The registrant hereby files as Exhibit 1 to this Report on Form 6-K its new corporate presentation which contains, among other things, disclosures regarding the registrant's planned phase 3 registrational study for the use of BL-8040 in autologous stem cell mobilization.

This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the registrant 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.

BioLineRx Ltd.

By: /s/ Philip Serlin

Philip Serlin Chief Executive Officer

Dated: June 12, 2017

Transforming Science Into Medicine

We advance early oncology and immunology compounds into valuable therapies for patients with high unmet needs

Corporate Presentation

June 2017

BIOLINERX

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 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.

BioLineRx Snapshot

  • · Drug development company focused on oncology & immunology:
    • BL-8040 (CXCR4 antagonist) with robust clinical program in immuno-oncology, AML and bone marrow transplantation
    • AGI-134 (alpha-Gal immunotherapy) activating a patient-specific, anti-tumor response to patient's own cancer neo-antigens
    • Immunology/fibrosis franchise under collaboration with Novartis Pharma
  • · Significant collaborations with leading pharma companies
    • Strategic collaboration with Novartis for joint development of innovative assets
    • Immunotherapy collaboration with Genentech in multiple oncology indications (BL-8040 & Atezolizumab)
    • Immunotherapy collaboration with Merck in pancreatic cancer (BL-8040 & Keytruda)

Main Pipeline Assets

Transforming Science Into Medicine

BL-8040

Best-in-class CXCR4 antagonist for multiple oncology indications

Confidential property: Not to be used without written authorization from Health Science Communications.

BL-8040 Highlights

  • · Best-in-class CXCR4 antagonist
    • Platform molecule with MOA relevant in multiple tumors
    • Most advanced compound targeting CXCR4
  • · Partnerships with leading companies and institutions (Genentech, Merck, MDACC)
  • · Multiple clinical studies ongoing or in final planning stages
    • Multiple studies under immunotherapy partnerships with Genentech and Merck
      • · Data readouts in 2017 and 2018
    • Large phase 2b study in AML consolidation treatment line running at full steam
      • Data readout in H2 2019; potential interim analysis in H2 2018
    • Initiation of phase 3 registrational study in autologous SCM planned for H2 2017
  • · Received Orphan Designation from FDA for AML & SCM
  • · Potential for multiple phase 3 studies under immunotherapy partnerships

Transforming Science Into Medicine

BL-8040 in Immuno-Oncology

BIOLINERX

Confidential property: Not to be used without written authorization from Health Science Communications.

BL-8040's MoA in Cancer Immunotherapy

  • · Immunostimulant BL-8040 is a powerful mobilizer of immune cells from the bone marrow and lymph nodes (T-cells, B-cells, immature dendritic-cells and NK-cells)
  • · Potentiator BL-8040 increases infiltration of immune cells into tumors (exhibiting a synergistic effect with anti PD1/PD-L1 immune checkpoint inhibitors)
  • · Microenvironment modifier BL-8040 affects the tumor microenvironment by decreasing CXCR4-mediated migration of immune suppressor cells [i.e. MDSCs, Tregs]

ర్తి

BL-8040 is a Powerful Mobilizer of Immune Cells (clinical data)

  • Healthy volunteers were treated with BL-8040 or placebo
  • · Single administration of BL-8040 triggered substantial mobilization
  • · Long receptor occupancy results in prolonged effect (≥ 24 hours)

BL-8040 Increases T-Cell Infiltration into Tumors (mice model)

  • · Model: Orthotropic syngeneic tumors in pancreas of C57BL/6 male mice
  • Treatment with BL-8040 for 10 consecutive days

Treatment with BL-8040 induces accumulation of CD3+ T-cells in PDA tumors

IHC: aCD3

BL-8040 Increases T-Cell Infiltration into Tumors (cont.)

· FACS analysis confirmed enrichment of immune cells within the tumor

* Tumor sections were enzymatically digested and single cell suspensions were analyzed by FACS ** Values in the table represent absolute cell count

BL-8040 Affects the Tumor Microenvironment (CXCR4/SDF-1 Immuno-Suppressive Role in Cancer)

  • · SDF-1 expression is an independent predictor of poor survival in cancer patients
  • · CXCR4/SDF-1 axis is key pathway mediating the attraction of immuno-suppressive cells (MDSCs, Tregs, pDCs) to the tumor environment
  • · CXCR4 inhibition selectively reduces infiltration of Tregs into tumors and inhibits the migration of MDSCs to the tumor

Immunotherapy Collaboration with Genentech

  • · Four phase 1b studies planned to investigate combination of BL-8040 with Genentech's Tecentriq™ (Atezolizumab - anti-PDL1 immune checkpoint inhibitor)
    • Genentech to sponsor and conduct three phase 1 b studies in multiple solid tumors
    • BioLineRx to sponsor and conduct phase 1 b study in (maintenance) AML
    • Open-label, repeated administration studies in up to 60 patients each
  • · Study endpoints
    • Clinical response, safety and tolerability
    • Multiple pharmacodynamic parameters
  • · Studies are expected to commence in H2 2017; top-line results expected in 2019

Immunotherapy Collaboration with Merck

  • · Phase 2a study to examine combination of BL-8040 with Merck's Keytruda® (anti-PD1 immune checkpoint inhibitor)
    • Up to 30 patients with metastatic pancreatic adenocarcinoma
    • Open-label, single-arm trial with sites in the US, Israel and South Korea
  • · Study endpoints
    • Clinical response, safety and tolerability
    • Multiple pharmacodynamic parameters, including ability to improve infiltration of T cells into tumor and their reactivity
  • · Study commenced at end of Q3 2016
    • Partial results expected H2 2017
    • Top-line results expected H2 2018

Transforming Science Into Medicine

BL-8040 in AML

Confidential property: Not to be used without written authorization from Health Science Communications.

BL-8040 Mechanism of Action in AML

  • · Binds CXCR4 with high affinity (1-10 nM)
  • · Maintains extended inhibition of CXCR4 through long receptor occupancy (>24 hours)
  • · BL-8040 induces apoptosis of AML blasts by down-regulation of survival factors
  • · Bone-marrow clearance eliminates minimal residual disease

BL-8040 in AML - Background and Direction

  • · Company conducted successful proof-of-concept phase 2a study in relapsed/refractory AML (45 patients)
    • Showed robust bone marrow clearance, induction of apoptosis and terminal differentiation of AML cells
    • Excellent safety and tolerability

AML - Clinical Development Status

  • · Results support accelerated development in AML space with potential elimination of minimal residual disease (MRD)
  • · Consolidation AML phase 2b study ongoing
    • 194 patients, double-blind, placebo controlled at ~25 sites in Germany
    • Enrollment ongoing: potential interim results in 2018; top-line results by end of 2019
  • · Maintenance AML phase 1b study (under Genentech collaboration) in late planning stages
    • Combination with Atezolizumab as maintenance therapy for high-risk, elderly AML patients
    • Up to 60 patients, open label study at multiple leading sites in the US
    • Expected to commence in H2 2017

Transforming Science Into Medicine

BL-8040 in SC Mobilization

Confidential property: Not to be used without written authorization from Health Science Communications.

Stem Cell Mobilization for Autologous Transplantation

  • · G-CSF is current standard for autologous stem cell mobilization
    • 4-6 daily injections of G-CSF, plus 1-4 apheresis sessions required
    • 50-70% of patients are poor mobilizers
    • For poor mobilizers, 1-4 daily injections of Mozobil on top of G-CSF are required
  • · Fast route to registration in autologous SCM
    • Registrational study expected to commence in H2 2017 based on confirmatory meeting with FDA held in April 2017:
      • · BL-8040 plus G-CSF will be compared to G-CSF plus placebo
      • · Study expected to enroll ~200 patients in total
      • · Primary endpoint: proportion of patients who mobilize ≥6 million CD-34+ cells in up to 2 leukapheresis sessions in MM patients
  • · Phase 2 allogeneic transplantation study ongoing as complementary indication
    • Successful partial results recently announced
      • Single injection of BL-8040 mobilizes sufficient amounts of cells without need for G-CSF
    • Topline results by end of 2017

BL-8040 is Powerful Mobilizer of CD34+ Cells

  • · Substantial HSC mobilization from BM to PB was recorded
  • · Consistent pattern of mobilization across all subjects treated with BL-8040

22

Single BL-8040 Administration Results in Robust Collection of Stem Cells Using Single Apheresis

Subject # Whole blood
processed (L)
9/2
CD34+ cells
CD34+/KG
(Donor weight)
CD34+/KG
(70kg recipient
weight)
5001 9.8 0.75 4,091,848 5,091,429
5002 16.0 1.01 11,964,615 11,998,800
5003 16.6 0.85 13,667,866 14,917,500
5004 16.2 0.76 10,154,834 11,794,114
5005 16.6 0.78 11,366,255 15,230,781
5006 16.5 0.87 13,068,548 14,711,451
5007 17.5 0.64 11,076,197 9,652,114
5008 16.7 0.61 9,623,736 9,994,937
Median 16.5 ± 2.3 L 0.77 ± 0.13 % 11.2 x 106
(± 2.8 x 106)
11.9 × 106
(±3.5 × 106)

CD34+ PB levels 24 hr post BL-8040 are still high even after leukapheresis

  • · Leukapheresis started 4 hrs post BL-8040 injection using the Spectra Optia® Apheresis System
  • · The median amount of collected stem cells was higher than 11 x 106 per kg

CXCR4 Competitor Landscape

Compound
(Company)
Dev.
Stage
Molecule
Type
Indications
(under development)
AML SCM IO
BL-8040
(BioLineRx)
Phase 2 Peptide
(SC)
Auto/Allo SCM;
AML (r/r, consolidation, maintenance);
Solid tumors (gastric, pancreatic, NSCLC)
Ph 2 Ph 3 ready Ph 1/2
(+Pembro/+Atezo)
Mozobil
(Genzyme/Sanofi)
Launched Small molecule
(IV)
Auto SCM;
AML; Solid tumors (pancreatic, ovarian and
colorectal cancers)
Ph 1/2 Launched
LY-2510924
(Eli Lilly)
Phase 2 Peptide
(IV)
r/r AML; solid tumors Ph Ph 1
(+Durvalumab)
Ulocuplumab
(BMS)
Phase 2 Ab
(IV)
AML Ph 1/2 Terminated
X4P-001
(X4
Pharmaceuticals)
Phase 2/3 Small molecule
(oral)
WHIM syndrome; RCC, melanoma;
ovarian cancer
Ph 1/2
(+Pembro/+Nivo)

BL-8040 is Best-in-Class vs. Competitors

BL-8040 Mozobil Ulocuplumab
Affinity for CXCR4 1-10 nM 84 nM SnM
CXCR4 Binding site Extracellular domains in the CXCR4
receptor
Trans-membrane regions in the
CXCR4 receptor
Extracellular domains in the CXCR4
receptor
Molecule Type Peptide Small molecule Ab
Plasma half-life 1-3 hr ~3-5 hr More than 24hr
Receptor occupancy More than 24 hr ~2 hr Not published
Cancer Cell Death Remarkable apoptosis in samples from
clinical study patients
(Phase 2 study rrAML)
Has no effect on cancer cell
apoptosis
(Reum H et al., 2015)
Apoptosis of AML cells. Modest
effect in patients.
(ASH 2013)
Mobilization
(fold increase
leukocytes/ blast)
4/8
(Phase 2 in rrAML)
1.8/2.8
(Uy G.L. et al., Blood 2017;
Phase 1/2 in rrAML)
2/5
(Becker P.S. et al; Blood 2014;
Phase1 in rrAML)
T-Cell Infiltration into
Tumors
Infiltration was demonstrated in
preclinical murine models
Infiltration was demonstrated in
preclinical murine models
Not published

Other remarks re BL-8040 (Abraham M et al., 2017):

  • · BL-8040 induces apoptosis of AML blasts by down-regulating ERK BCL-2, MCL-1 and cyclin-D1
  • · BL-8040 synergizes with FLT3 and BCL-2 inhibitors to induce AML cell death
Superior Neutral Inferior

25

BL-8040 Summary

  • · Most advanced antagonist of CXCR4, an exciting and validated target
  • · Robust platform for multiple oncology indications
    • Immunotherapy
    • AML
    • Stem-cell mobilization/transplantation
  • Significant efficacy demonstrated in numerous clinical studies
  • · Partnerships with Genentech and Merck in immuno-oncology
  • · Registrational study in autologous SCM expected to start in H2 2017

Transforming Science Into Medicine

AGI-134

Alpha-Gal immunotherapy, activating anti-tumor response to patient's own neoantigens

Confidential property: Not to be used without written authorization from Health Science Communications.

AGI-134 Highlights

  • · Unique mechanism harnessing naturally occurring immune machinery
  • · Promotes systemic anti-tumor response against patient's own tumor antigens
  • · Applicable for large array of tumors
  • · Targets primary tumor, as well as existing and potential future metastases
  • · Reduces immuno-suppressive nature of tumor microenvironment
  • · Near-clinical stage (following pre-IND meeting)
    • Phase 1 in solid tumors expected to initiate in H1 2018; final preparations underway
  • · Proposed initial indications: melanoma, liver, head and neck, colorectal, breast cancer, lymphoma
    • Studies to include substantial biomarker identification

AGI-134: Key Efficacy Findings

  • · In vitro and in vivo studies have validated the underlying steps of the MOA
  • · Single dose of AGI-134 demonstrated systemic effect by protecting mice from secondary tumor development for over 90 days
  • · Combination of AGI-134 with immune checkpoint inhibitor (PD-1) gave increased efficacy over either agent alone

AGI-134: Unique MOA Among Intratumoral Agents

Oncolytic
viruses
PAMPs AGI-134
Injected tumor cells identified by naturally occurring pre-existing antibodies >
Antibody-bound tumor cells destroyed by activated complement and ADCC >
Tumor neoantigens release by spilling > >
Antibody-activated complement system creates pro-inflammatory milieu in the
tumor microenvironment
>
Complement chemo-attractants recruit immune cells to the tumor >
Activation of antigen presenting cells and increased (APCs) uptake of fumor
antigens
> > >
APCs induce a follow-on systemic immune response by the stimulation and
clonal expansion of T cells
> >

AGI-134 Summary

  • · Novel and demonstrated mechanism of action
  • · Technology potential
    • Addresses wide range of poorly treated solid tumors
    • Transforms "cold" into "hot" tumors
    • Targets patient's neoantigens
  • · Strong pre-clinical data, clear development pathway discussed with MHRA and FDA
  • · Near-clinical stage, with first-in-man study expected to initiate H1 2018
  • · Phase 1/2 development plan designed to include comprehensive biomarker strategy
  • · Demonstrated synergy with immune checkpoint inhibitors
  • · Acquisition of Agalimmune provides BioLineRx with several earlier-stage projects, as well additional capabilities to augment focus on immunology and oncology

Transforming Science Into Medicine

Corporate

Confidential property: Not to be used without written authorization from Health Science Communications.

BioLineRx Management

  • · Philip A. Serlin, CPA, MBA Chief Executive Officer
    • Served as the Company's CFO and COO from 2009 to 2016. Previously CFO and COO of Kayote Networks and CFO Tescom Software Systems Testing, Background includes senior positions at Chiaro Networks and at Deloitte in Tel Aviv, and at the SEC in Washington, D.C.
  • · Mali Zeevi, CPA Chief Financial Officer
    • Served as the Company's Senior of Finance and Reporting 2009-2016. Previously Vice President Finance at Tescom Software Systems Testing and manager at PriceWaterhouseCoopers.
  • · David Malek, MBA Chief Business Officer
    • Joined the Company in 2011 as Vice President of Business Development. Previous management positions at Sanofi-Aventis, including Director of Oncology - New Products and Business Development.
  • · Ella Sorani, PhD VP Development
    • Joined the Company in January 2017. Previous 16 years served in a number of management positions in the global R&D division at Teva Pharmaceutical Industries. In most recent position, led global development of one of Teva's leading innovative late stage compounds.
  • · Abi Vainstein, MD VP Clinical and Medical Affairs
    • Served as the Company's Senior Medical Director from 2014 to 2016. Previously Director and Clinical Program Leader for COPAXONE®, and several other senior medical positions at Teva Pharmaceutical Industries.

Strategic Collaboration with Novartis

  • · Novartis selected BLRX as its partner for asset identification and early development
    • Exclusive first look at all Israeli-based projects scouted by BioLineRx
    • Co-develop selected projects through clinical proof-of-concept (POC)
  • · Unique collaboration provides lasting shareholder value and key insights
    • 3 projects brought under collaboration so far, in areas of fibrosis and inflammation
  • · Financial highlights:
    • Upfront \$10 million equity investment in BLRX
    • Upon selection of clinical project (or when a project reaches IND), BioLineRx receives:
      • = \$5 million option fee (non-dilutive)
      • = 50% of remaining R&D expenses up to POC (in equity at a premium to market)
    • Novartis receives right of first negotiation for full out-license upon clinical POC

Financial Summary

· Cash position

  • \$55 million as of April 30, 2017
  • Existing financial resources fund operational requirements into 2019

· Capital structure

  • Traded on NASDAQ and TASE (Symbol: BLRX)
  • 96 million shares outstanding; 104 million fully diluted
  • US shareholders represent ~70% of investor base, including key life-sciences investors

· Other

  • ~50 employees, approximately 2/3 with advanced degrees
  • Analyst coverage: JMP Securities, HC Wainwright, Maxim Group

Principal Expected Development Milestones in 2017/2018

201 7

ا OZ

8

BL-8040 (Allogeneic SCM) phase 2 partial results

BL-8040 (Pancreatic Cancer) phase 2 partial results BL-8040 (Autologous SCM) phase 3 initiation BL-8040 (AML Maintenance) phase 1b initiation BL-8040 (Multiple Solid Tumors) phase 1b initiation BL-8040 (Allogeneic SCM) phase 2 top-line results

AGI-134 (Multiple Solid Tumors) phase 1/2 initiation

BL-8040 (Pancreatic Cancer) phase 2 top-line results

BL-8040 (AML Maintenance) phase 1 b partial results

BL-8040 (Multiple Solid Tumors) phase 1b partial results

BL-8040 (AML Consolidation) phase 2b interim analysis

Does not include milestones expected from newly in-licensed programs

Takeaways ......

  • · Focus on oncology and immunology (mainly immuno-oncology)
  • · 9 clinical studies ongoing or planned for next 12-18 months
  • · Read-out from 3-4 phase 2 studies over next 12-18 months
  • · Initiation of phase 3 registrational study expected in H2 2017
  • · Significant collaborations with 3 of the leading global pharma companies
  • · Anticipated new clinical/advanced pre-clinical compounds to enter pipeline
  • · Continued execution of strategic transactions as opportunities arise

Thank You

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