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 September 2016
 
_______________________
 
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-F ☑          Form 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:          
 
Yes ☐          No ☑
 


On September 22, 2016, the registrant will be hosting an investor breakfast meeting in New York City beginning at 9:00 am EDT. At the meeting, the registrant will present updates about its corporate objectives, BL-8040 and business development activities. The foregoing presentations are filed as exhibits to this Report on Form 6-K as listed below:
 
Exhibit 1: Registrant’s Corporate Presentation;
 
Exhibit 2: Registrant’s BL-8040 Presentation; and
 
Exhibit 3: Registrant’s Business Development Update
 
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.
 
 
BioLineRx Ltd.
 
       
 
By:
/s/ Philip Serlin  
    Philip Serlin  
    Chief Financial and Operating Officer  
       
Dated: September 22, 2016
 

 

 
Exhibit 1
 
 

 Investor BreakfastCorporate Presentation  September 22, 2016 
 

 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 & immunologyNASDAQ/TASE traded; strong balance sheetTransforming science into medicineLeverage selected early-stage programs through advanced clinical trials and registrationLead program is BL-8040 oncology platform for multiple indicationsBest-in-class CXCR4 antagonistSignificant collaborations with leading pharma companiesStrategic collaboration with Novartis for joint development of Israeli-sourced assetsImmunotherapy collaboration with Genentech in multiple oncology indications (BL-8040 & Atezolizumab)Immunotherapy collaboration with Merck in pancreatic cancer (BL-8040 & Keytruda)Out-licensing of European rights for BL-5010 to Perrigo 
 

 Where are we at present?   
 

                   Current Pipeline  PROJECT    INDICATION      PARTNERS  PRE-CLINICAL  PHASE I  PHASE II  PHASE III  REGULATORY APPROVAL  CANCER  IMMUNOLOGY  OTHER  Consolidation AML  Maintenance AML  Gastric cancer  Non-small cell lung cancer  Pancreatic cancer*  Pancreatic cancer  Stem-cell mobilization  Celiac disease and gluten sensitivity  Type 1 diabetes  NASH  BL-8040  BL-7010  BL-9020  BL-1210  BL-5010                      Regional out-license to Perrigo  Developed under strategic collaboration with Novartis  Collaboration with JHL for China and Southeast Asia  Immunotherapy collaboration with Merck (Pembrolizumab)  Immunotherapy collaboration with Genentech (Atezolizumab)            Skin Lesions  *Indication/protocol under final review. 
 

   Well Funded  Cash position~$42 million as of June 30, 2016Funds operational capital through end of 2018/into 2019Capital structureTraded on NASDAQ and TASE (Symbol: BLRX)56 million shares outstanding; 65 million fully dilutedUS shareholders represent ~70% of investor base, including key life-sciences investorsNovartis is largest shareholder; holds ~9% of CompanyOther~50 employees, approximately 2/3 with advanced degreesAnalyst coverage: JMP Securities, Roth Capital, Maxim Group 
 

 Current Status Report  Program  Current status today  Looking forward into 2017  BL-8040AML  r/r AML - successful phase 2aConsolidation AML phase 2b in full gear; understandings with EU agencies    BL-8040Immunotherapy  Merck agreement signed; phase 2a initiatedGenentech agreement signed    BL-8040SC Mobilization  Phase 2 initiated; understandings with FDA    BL-7010  Device designation in EUProgress on food supplement pathway, including new formulation, preps for GRAS designation and efficacy study    BL-5010  CE mark and product launch by Perrigo in Europe for initial OTC indication    Novartis Collaboration  Full alignment on screening process and therapeutic areasInitiation of first projects under collaboration    iPharma JVin China  JV established and operating   
 

 
 Our future plans – for 2017 and beyond    9 

 2017 Expected Achievements  Program  Current status today  Looking forward into 2017  BL-8040AML  r/r AML - successful phase 2aConsolidation AML phase 2b in full gear; understandings with EU agencies  Consolidation AML study continues; LPI in studyStart of immunotherapy maintenance AML phase 1b  BL-8040Immunotherapy  Merck agreement signed; phase 2a initiatedGenentech agreement signed  Merck - partial results announcedGenentech - multiple phase 1b studies initiated and in full gear  BL-8040SC Mobilization  Phase 2 initiated; understandings with FDA  Interim and final results  BL-7010  Device designation in EUProgress on food supplement pathway, including new formulation, preps for GRAS designation and efficacy study  GRAS designationStart and completion of efficacy studyInitiation of BD process  BL-5010  CE mark and product launch by Perrigo in Europe for initial OTC indication  Expansion of launch by PerrigoPartnering deal for US market  Novartis Collaboration  Full alignment on screening process and therapeutic areasInitiation of first projects under collaboration  Progress on existing projects4-5 new projects added  iPharma JVin China  JV established and operating  New projects, high valuations, value-added exposure to Asia 
 

 2017 Expected Achievements (cont.)  In addition to the above achievements, BioLineRx also expects to bring two additional IND-ready projects into the BLRX pipelineduring 2017 
 

   Expected Pipeline at End of 2017                    PROJECT    INDICATION      PARTNERS  PRE-CLINICAL  PHASE I  PHASE II  PHASE III  REGULATORY APPROVAL  CANCER  IMMUNOLOGY  OTHER  Consolidation AML  Maintenance AML  Gastric cancer  Non-small cell lung cancer  Pancreatic cancer*  Pancreatic cancer  Stem-cell mobilization  TBD  TBD  Celiac disease and gluten sensitivity  Type 1 diabetes  NASH  TBD  TBD  BL-8040  BL-7010  BL-9020  BL-1210  BL-5010                      Regional out-license to Perrigo  Developed under strategic collaboration with Novartis  Collaboration with JHL for China and Southeast Asia  Immunotherapy collaboration with Merck (Pembrolizumab)  Immunotherapy collaboration with Genentech (Atezolizumab)            Skin Lesions  TBD  TBD    New Project  New Project      New Project  New Project      Developed under strategic collaboration with Novartis  Developed under strategic collaboration with Novartis      New Project  New Project  Developed under strategic collaboration with Novartis  Developed under strategic collaboration with Novartis    *Indication/protocol under final review. 
 

 BioLineRx in Five Years  Our plan is to become a significant player in the biotech industryWith critical mass of advanced projects in developmentAlongside portfolio of revenue-generating assetsWe intend to achieve the following:2-3 products in the market, with material amount of sustainable revenuesPipeline of 3-5 clinical stage assetsFull infrastructure to advance assets through registration and market launchExpansion of strategic collaborations with global pharma companies, with direct access to cutting edge technologiesOne or more significant out-licensing deals with global pharma companyExecute strategic transactions as opportunities arise (in addition to traditional in-licensing model) 
 

 Closing slides   
 

 2017  Major Milestones – 2016 and 2017    BL-8040 (SC Mobilization) phase 2 partial results    BL-8040 (SC Mobilization) phase 2 study completion    BL-8040 (AML Consolidation) LPI    BL-8040 (AML Maintenance) phase 1b initiation    BL-8040 (Multiple Solid Tumors) phase 1b initiation    BL-5010 (Skin Lesions) second product completion    BL-8040 immunotherapy agmt with Merck      BL-8040 (AML) phase 2 completion      BL-8040 (SC Mobilization) phase 2 initiation      BL-5010 (Skin Lesions) CE Mark approval      BL-5010 (Skin Lesions) first product launch      BL-8040 (AML) – discussions with agencies    2016  BL-7010 regulatory pathway determination      BL-8040 (Pancreatic Cancer) phase 2 initiation      BL-8040 immunotherapy agmt with Genentech       BL-7010 (Gluten Sensitivity) efficacy study initiation     BL-8040 (Pancreatic Cancer) phase 2 partial results    BL-7010 (Gluten Sensitivity) efficacy study completion   
 

 BioLineRx in Five Years  Our plan is to become a significant player in the biotech industryWith critical mass of advanced projects in developmentAlongside portfolio of revenue-generating assetsWe intend to achieve the following:2-3 products in the market, with material amount of sustainable revenuesPipeline of 3-5 clinical stage assetsFull infrastructure to advance assets through registration and market launchExpansion of strategic collaborations with global pharma companies, with direct access to cutting edge technologiesOne or more significant out-licensing deals with global pharma companyExecute strategic transactions as opportunities arise (in addition to traditional in-licensing model) 
 

   Philip Serlin, CPA, MBAChief Executive Officerwww.biolinerx.com +972-8-642-9100    Thank  You 


 
Exhibit 2
 
 

 BL-8040  Best-in-class CXCR4 antagonist for treatment of multiple oncology indications 
 

 BL-8040 Highlights  Platform Molecule: Multiple cancer and hematological indicationsReceived Orphan Designation from FDA for AML & SCMMode of Action: Inhibits CXCR4 (a cell surface protein)CXCR4 overexpressed in >70% of tumors; correlates with severity; well validatedIncreases sensitivity to anti-cancer agents by affecting tumor microenvironmentSignificant clinical superiority in immune cell mobilization Potential synergy with multiple immuno-oncology platformsInduces cancer cell death (apoptosis)Multiple clinical studies ongoing or in final planning stagesIncluding immunotherapy collaborations with Genentech and Merck for multiple cancer indications 
 

 BL-8040 MoA in Immuno-Oncology   
 

 BL-8040 Potential 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)                                                                                                                                                      PD-L1/PD1  CXCR4  SDF1  Immunosuppressive cells  Tregs  CD8+ CTL                                                                                                                                                                                                BL-8040                                                                                                                                      PD1 Ab                            PD-L1 Ab    PD1 or PD-L1 Ab.  BL-8040 
 

     BL-8040 is a powerful mobilizer of immune cells (clinical data)  Healthy volunteers treated with BL-8040 or placebo (clinical trial BL-8040.02)Single administration of BL-8040 (1 mg/kg) triggered substantial increase in T-cells, B-cells , NK-cells and Dendritic-cells in the bloodLong receptor occupancy results in prolonged effect (≥ 24 hours)   T cells  BL-8040 Placebo   Blood levels  Fold change from time 0    B cells  NK cells 
 

   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 as single agent for 10 consecutive days  CD3 IHC  Treatment with BL-8040 induces accumulation of CD3+ T-cells in PDA tumors 
 

   The immuno-suppressive role of CXCR4 in the tumor microenviroment  CXCL12 expression is an independent predictor of poor survivalCXCR4-CXCL12 axis is the key pathway mediating the attraction of immuno-suppressive cells (MDSCs, T-regs, pDCs) to the tumor microenvironment preventing local T-cell activationCXCR4 inhibition selectively reduces intratumoral Tregs-cell infiltrationCXCR4 inhibition selectively inhibits the migration of MDSCs to the tumor  Ovarian epithelial carcinoma cells express functional SDF-1     CXCR4 inhibition  Righi E. et al., Cancer Res 2011; Zou W et al., Nature Medicine, 2001; Obermajer et al., Cancer Res, 2011  High CXCR4 expression in cancer–isolated MDSCs   MDSCs migration is inhibited by CXCR4 blockade 
 

 BL-8040 Clinical Development Program   
 

 BL-8040 Clinical Development Program   Pre-Clinical  Phase I  Phase II  Phase III  INDICATION  PROTOCOL  BL-8040.07  SCM as Single Agent (Allogeneic)  AML Consolidation  ACUTE MYELOID LEUKEMIA (AML)  STEM CELL MOBILIZATION  Immunotherapy Combination   Pancreatic (Pembrolizumab)  COMBAT  AML Maintenance (Atezolizumab)  BLAST  BATTLE  MORPHEUS  Pancreatic (Atezolizumab)  MORPHEUS  Gastric (Atezolizumab)  MORPHEUS  NSCLC (Atezolizumab)              ONGOING  PLANNED  Planned to initiate H1/2017  Planned to initiate Q3/2016  Planned to initiate H1/2017  Planned to initiate H1/2017  Planned to initiate H2/2017 
 

 AML – Background and Direction  Company conducted successful proof-of-concept phase 2a study in relapsed/refractory AML38% composite remission rate versus 20% historical benchmarkShowed longer than expected durability of remissionsExcellent safety and tolerabilityShowed direct triple anti-leukemic activity: robust mobilization, induction of apoptosis and terminal differentiation of AML cells Results support accelerated development in AML spaceBL-8040’s high response rate indicates selective effect on chemotherapy resistant cellsBL-8040 showed direct anti-leukemic activity and bone marrow clearance by mediated robust mobilization suggesting potential elimination of minimal residual diseaseResults encourage accelerated development of two specific AML treatment lines: (i) consolidation and (ii) maintenance 
 

 AML – Clinical Development Status  Consolidation AML phase 2b study ongoing194 patients, double-blind, placebo controlled at ~25 sites in GermanyEnrollment ongoingInterim results expected in 2018Maintenance AML phase 1b study (in collaboration with Genentech)Combination study with Atezolizumab as maintenance therapy for high-risk elderly AML patients following induction treatmentUp to 60 patients, open label study at multiple leading sites in the USIn late planning stages, expected to commence in first half of 2017 
 

   Phase IIb - Consolidation Treatment for AML Patients  A Phase II, double- blind, placebo controlled, randomized, multicenter study to assess the efficacy of BL-8040 in AML patients in first complete remissionStudy DesignDouble blind, placebo controlled, repeated administrations, multiple treatment cycles. TreatmentTwo or three cycles (age based) of consolidation with high-dose Ara-C together with either BL-8040 or Placebo. Ara-C 1 g/m2 per dose for patients older than 60 years and 3 g/m2 for patients younger than 60 years. Ara-C is administered IV twice a day (10 am and 10 pm) over 3 hours on day 1, 3 and 5. Placebo or BL-8040 is administered SC at 8 a.m. on days 1, 2, 3, 4 and 5 of each consolidation cycle. EndpointsTo compare the Relapse Free Survival (RFS) 3, 6, 9, 12 and 18 months after randomizationTo assess the toxicity, safety and tolerability of BL-8040 in combination with high-dose Ara-CTo assess MRD (by FACS/PCR) at time of enrollment and during the follow up period (3, 6, 9, 12 and 18 months)To assess overall survival (OS) as an open label extension  SCREENING  TREATMENT PERIOD  FOLLOW-UP  AGE <60  BM Biopsy                  Cycle 1  Cycle 2  Cycle 3  Day  1  2  3  4  5  28    1  2  3  4  5  28    1  2  3  4  5  28    EOT  6M  9M  12M  18M  BL-8040                                Ara-C                   
 

 Phase Ib - Combination with Immunotherapy as Maintenance Treatment for AML Patients  A Phase Ib, Multicenter, Single Arm, Open-label study, to Evaluate the Safety and Efficacy of BL-8040 and Atezolizumab combination for maintenance treatment in AML elderly High Risk patientsStudy DesignOpen label, repeated administrations, multiple treatment cycles. High risk AML patients unfit/not planned for transplant; Maintenance after consolidation for patients in CR1TreatmentBL-8040 is administered SC on days 1-3 of each 21-day cycle Atezolizumab is administered IV on day 2 of each 21-day cycleEndpointsTo assess Relapse Free survival assessed from the day of CR1 until relapseTo assess the toxicity, safety and tolerability of BL-8040 in combination with AtezolizumabTo assess MRD (by FACS) at time of enrollment and on treatmentTo assess overall survival (OS)    SCREENING  BL-8040 + ATEZOLIZUMAB  REPEATED CYCLES UNTIL PROGRESSION  BL-8040              Atezolizumab      Cycle 1  Cycle 2  1  21    1  21    Bone marrow Aspiration          Bone marrow Aspiration will be done at Baseline, Month 1, 2, 3, 6, 9,12 and then every 6 months till discontinuation 
 

 Immunotherapy Collaboration with Genentech  Several phase 1b studies to investigate combination of BL-8040 with Genentech’s TecentriqTM, (anti-PDL1 immune checkpoint inhibitor) in multiple cancer indicationsGenentech to sponsor and conduct several phase 1b studies in multiple solid cancer indications (gastric, NSCLC, pancreatic)BioLineRx to sponsor and conduct phase 1b study in (maintenance) AMLOpen-label, multicenter, repeated administrations studiesStudy endpointsClinical response, safety and tolerabilityMultiple pharmacodynamic parametersStudies are expected to commence H1 2017 
 

 Phase Ib - Combination with Tecentriq for Solid tumors    SCREENING  BL-8040 + ATEZOLIZUMAB  REPEATED CYCLES UNTIL PROGRESSION  BL-8040MONOTHERAPY  BL-8040  Cycle 1  Cycle 2  1  5    8  29    1  21    A basket phase Ib, multicenter, open-label study to Assess the Safety and Efficacy of BL-8040 in Combination with Atezolizumab in Patients with NSCLC, Gastric and Pancreatic CancerStudy DesignOpen label, repeated administrations, multiple treatment cycles until progressionTreatmentDaily SC BL-8040 injection as monotherapy for five consecutive days Combination part - On day 8 start combination therapy consisting of SC BL-8040 TIW and IV of Atezolizumab E3W The combination therapy will continue for up to two years, or until progression, clinical deterioration or early termination, whichever comes firstEndpointsTo assess Objective Response Rate (ORR) according to RECIST 1.1 criteria.Progression-free and Overall survivalSafety and tolerability of the combinationMultiple pharmacodynamic parameters   Atezolizumab                                                   
 

 Immunotherapy Collaboration with Merck  Phase 2a study to examine combination of BL-8040 with Merck’s Keytruda® (anti-PD1 immune checkpoint inhibitor) in pancreatic cancerUp to 30 patients with metastatic pancreatic adenocarcinomaOpen-label, multicenter, single-arm trialSites in the US, Israel and South KoreaStudy endpointsClinical response, safety and tolerabilityMultiple pharmacodynamic parameters, including ability to improve infiltration of T cells into tumor and their reactivity.Study will commence by end Q3 2016All regulatory submissions were completedPartial results expected H2 2017Top-line results expected H2 2018 
 

 Phase IIa - Combination with Keytruda for PDAC  A phase IIa, multicenter, open-label study to Assess the Safety and Efficacy of BL-8040 in Combination with Pembrolizumab in Patients with Advanced Pancreatic CancerStudy DesignOpen label, repeated administrations, multiple treatment cycles until progressionTreatmentDaily SC BL-8040 injection as monotherapy for five consecutive days Combination part - On day 8 start combination therapy consisting of SC BL-8040 TIW and IV of Pembrolizumab E3W The combination therapy will continue for up to two years, or until progression, clinical deterioration or early termination, whichever comes firstEndpointsTo assess Objective Response Rate (ORR) according to RECIST 1.1 criteria.Progression-free and Overall survivalSafety and tolerability of the combinationMultiple pharmacodynamics parameters     SCREENING  BL-8040 + PEMBROLIZUMAB  REPEATED 21 DAY CYCLES UNTIL PROGRESSION  BL-8040MONOTHERAPY  BL-8040    Pembrolizumab  Cycle 1  Cycle 2  1  5    1  21    Biopsy        1  21                                            1  5    1  21    1  21    Imaging        (1-15 pt)  (16-30 pt) 
 

 BL-8040 Development and Commercialization Strategy in SCM   
 

     Stem Cell Mobilization for Transplantation  G-CSF is current standard for stem cell mobilization4-6 daily injections of G-CSF, plus 1-4 apheresis sessions requiredG-CSF is associated with bone pain and other side effectsG-CSF is not approved for allogeneic transplantationNo agents are approved for allogeneic transplantationPhase 1 results support BL-8040 as single agent one day collection regimen Type B meeting with the FDA held in October 2015Phase 2 study allogeneic transplantation ongoingCollaboration with Washington University School of Medicine, Division of Hematology and OncologyPartial results by end of 2016; topline results by end of 2017 
 

 BL-8040 Long Term Clinical Development Plan  Development of BL-8040 for SCM for allogeneic stem cell transplantation The overall goal is to demonstrate that BL-8040 produces a similar quality of allograft as that produced by G-CSFStudies will likely demonstrate advantages:Shorter duration of treatment prior to leukapheresis – single BL-8040 injection versus 4-5 injections of G-CSF with or without off label treatment with Plerixafor.Reduction in the number of leukapheresis collections in order to obtain an adequate amount of cells for bone marrow transplant.Overall donor treatment duration of 1-2 days.Development plan toward registration:Single pivotal studyTotal of 370 treated volunteersLong-term follow up of healthy donors could be done in a post marketing settingCompany considers taking all the way toward commercialization, either with a partner or by itself 
 

 BL-8040 Long Term Clinical Development Strategy      2016    2017    2018  2019  2020    2021    2022  SCM Allogeneic    Ongoing Ph2a        Long term follow up      Drug registration (NDA)    Commercialization          Prep for Ph3      Phase 3               AMLConsolidation    Ongoing Ph2b BLAST study                    Drug registration (NDA)        Prep for Ph3    Potential Ph3 conducted by BioLineRx and/or partner                Immuno-Oncology   MSD    Ph2a PDAC COMBAT study         Out licensing deal and/or Ph3 conducted by partner                  Ph2a PDAC MDACC study                      GENE      Ph2a AML BATTLE study        Out licensing deal and/or Ph3 conducted by partner                  Ph2a solid tumors MORPHEUS study                    Phase 3 ready positionInitial input from open label immuno-oncology studiesAML consolidation interim results during 2018    Late stage SCM Phase 3 – NDA for SCM Final data from immuno-oncology studiesAdvanced stage of development for AML consolidation   Multiple value generating events in coming months with strong potential for partnership deal early in 2018 
 

 BL-8040 Summary  BL-8040 is platform for multiple solid and liquid oncology indicationsFocus on immunotherapy, AML and allogeneic stem-cell transplantationBL-8040 has demonstrated efficacy in several clinical studiesBL-8040’s MoA has been clinically validatedCXCR4 is a validated targetCollaborations with leading global pharma companies provide significant additional validation of program potential 
 

   Thank  You 


 
Exhibit 3
 
 

 Investor BreakfastBusiness Development Update  September 22, 2016 
 

 Focus on Two Main Initiatives  Collaborations with top global pharma in cancer immuno-therapyRationaleStructure and detailsStrategic collaboration with NovartisStatusExpectations for the next 12 months 
 

 BL-8040 In Immuno-oncology   
 

   Why Do We Push BL-8040 in Immuno-oncology?  Scientific Rationale  Multiple ways to potentiate I/O agents  Widely applicable for several classes of I/O  Value and Potential of I/O  Most significant class in oncology  Large unmet need still exists for many patients  Competition for advantage via combinations  Limited Competition in CXCR4  Very few clinical-stage CXCR4 antagonists  Even fewer agents which do not belong to Big Pharma  
 

 Merck Partnership Structure  Explore combination with Keytruda, a PD-1 antagonistOne of leading I/O agents, blockbuster potential, applicability in multiple tumor typesPhase 2a study in metastatic pancreatic cancer:Keytruda single-agent has almost no effectClear scientific rationale for the combination with CXCR4 antagonistEven a small clinical improvement would have clear significanceBioLineRx is the sponsor of the clinical studyMerck provides Keytruda and performs some of the sample analysisBoth parties have the right to continue to Phase 3 with access to the other party’s compound 
 

 Genentech Partnership Structure  Explore combination with Atezolizumab (Tecentriq), PD-L1 antagonistNewly approved, blockbuster potential, applicability in multiple tumor typesLarge clinical program to explore the combination in multiple tumor types where:There is a clear unmet need; Atezo single-agent activity leaves potential for improvementClear scientific rationale for the combination with CXCR4 antagonistBioLineRx is the sponsor of the clinical study in AMLAn area where BioLineRx has significant expertise with BL-8040Genentech is the sponsor of all solid tumor studies1st wave (begin H1 2017): Gastric, NSCLC and potentially Pancreatic cancerPotential to add an additional wave of up to 3 indications in H2 2017 Both parties have the right to continue to Phase 3 with access to the other party’s compound 
 

 Summary of Immuno-Oncology Collaborations  Position BL-8040 as the leading independent CXCR4 antagonist for immuno-oncology combinationsPartnerships with 2 of the 3 leaders in immuno-oncologyPartnerships allow to explore potential in various aspects, thus increasing value and probability-of-success:Combination with both PD-1 and PD-L1 antagonistsAbility to compare combinations in one tumor (pancreatic cancer)Explore combination in at least 4 different tumors, both solid and liquidLimited investment compared to large scale of the clinical programRetain flexibility for future stepsNo exclusivity with a single partnerCan consider partnering or moving to registration depending on options 
 

 Novartis alliance - status   
 

 Successful Strategic Collaboration with Novartis  The first projects were in-licensed under the collaborationCurrent projects focus on NASHGrowing, high-potential therapeutic areaAligned with our focus on also building an immunology franchiseProjects are first-in-class, potentially disease-modifying agents; close collaboration with Novartis on the development planWe expect to in-license an additional 4-5 projects under the collaboration during the next year1-2 additional projects to be in-licensed in 2016Most projects would likely be aligned with our therapeutic area focusContinued commitment and strong collaboration on behalf of NovartisGreat validation for the company’s scouting and development capabilitiesPotential for repeated partnering with Novartis at a significantly reduced financial risk  
 

   Thank  You