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6-K
BIOLINERX LTD. filed this Form 6-K on 01/09/2017
Entire Document
 

 
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 January 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-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 ☑
 

 
The registrant hereby files as Exhibit 1 to this Report on Form 6-K its new corporate presentation in connection with its upcoming meetings at the J.P. Morgan Healthcare and Biotech Showcase conferences taking place this week in San Francisco.
 
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: January 9, 2017
 


Exhibit 1

 
 Confidential property: Not to be used without written authorization from Health Science Communications.  Corporate PresentationJanuary 2017 
 

 *  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. 
 

 *  Drug development company focused on oncology & immunology in three main areas:Immuno-oncology for multiple solid and liquid tumorsAcute myeloid leukemia (AML)Stem-cell mobilization for bone-marrow transplantationTransforming science into medicineWe leverage selected early-stage programs through advanced clinical trials and registrationLead program is BL-8040 oncology platform for multiple oncology indicationsSignificant collaborations with leading pharma companiesStrategic collaboration with Novartis for joint development of Israeli-sourced assetsImmunotherapy collaboration with Genentech in multiple oncologyindications (BL-8040 & Atezolizumab)Immunotherapy collaboration with Merck in pancreatic cancer (BL-8040 & Keytruda)NASDAQ/TASE traded (symbol BLRX); strong balance sheet  BioLineRx Snapshot 
 

 *  OTHER  Main Pipeline Assets  PROJECT  INDICATION  PARTNERS  PRE-CLINICAL  PHASE 1  PHASE 2  PHASE 3  REGULATORY APPROVAL  CANCER  IMMUNOLOGY  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  Liver failure diseasesDry eye syndrome  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  Developed under strategic collaboration with Novartis  BL-1220  *Indication/protocol under final review.  BL-1230  Developed under strategic collaboration with Novartis 
 

 Confidential property: Not to be used without written authorization from Health Science Communications.  BL-8040  Best-in-class CXCR4 antagonist for treatment of multiple oncology indications 
 

 *  BL-8040 Highlights  Platform Molecule: Multiple cancer indicationsFocus on immunotherapy, AML and stem-cell mobilization (SCM)Received 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 stem-cell mobilizationStrong evidence of robust immune cell mobilization Potential synergy with multiple immuno-oncology platformsInduces cancer cell death (apoptosis)Multiple clinical studies ongoing or in final planning stagesMultiple studies under immunotherapy collaborations with Genentech and MerckLarge phase 2b study in AML consolidation treatment line running at full steamInitiation of phase 2/3 registrational study in autologous SCM planned for H2 2017 
 

 *  BL-8040 Clinical Development Program  INDICATION  PROTOCOL  STEM CELL MOBILIZATION  ONGOING  PLANNED  BL-8040.13  SCM (Autologous)  Planned to initiate H2/2017 
 

 Confidential property: Not to be used without written authorization from Health Science Communications.  BL-8040 in Immuno-Oncology 
 

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

 *  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 administration studies in up to 60 patients eachStudy endpointsClinical response, safety and tolerabilityMultiple pharmacodynamic parametersStudies are expected to commence in 2017; partial results in 2018 
 

 *  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 reactivityStudy commenced at end Q3 2016Partial results expected H2 2017Top-line results expected H2 2018 
 

 Confidential property: Not to be used without written authorization from Health Science Communications.  BL-8040 in AML 
 

 *  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’s direct anti-leukemic activity and robust bone marrow clearance suggest potential elimination of minimal residual diseaseResults encourage accelerated development in 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 ongoingPotential interim results in 2018Maintenance AML phase 1b study (under Genentech collaboration) in late planning stagesCombination 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 H2 2017 
 

 Confidential property: Not to be used without written authorization from Health Science Communications.  BL-8040 in SC Mobilization 
 

 *  Stem Cell Mobilization for Autologous Transplantation  G-CSF is current standard for autologous stem cell mobilization4-6 daily injections of G-CSF, plus 1-4 apheresis sessions required50-70% of patients are considered poor mobilizersFor poor mobilizers, 1-4 daily injections of Mozobil on top of G-CSF are requiredRobust clinical results support BL-8040 as best-in-class mobilization agentFastest route to registration in autologous SCMPrior understandings with regulatory authorities in multiple myeloma and NHLConfirmatory meeting with FDA planned for Q2 2017Phase 2/3 registrational study planned to commence in H2 2017Phase 2 allogeneic transplantation study ongoing as complementary indicationCollaboration with Washington University School of Medicine, Division of Hematology and OncologyPartial results by Q1 2017; topline results by end of 2017 
 

 *  BL-8040 Summary  BL-8040 is a robust platform for multiple oncology indicationsImmunotherapyAMLStem-cell mobilization/transplantationBL-8040 has demonstrated robust efficacy in a number of clinical studiesCXCR4 is a validated targetBL-8040 has a clinically validated MoASignificant collaborations with leading global pharma companies provide meaningful validation of program potentialPhase 2/3 registrational study in autologous SCM expected to start in H2 2017 
 

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

 *  Strategic Collaboration with Novartis  Novartis selected BioLineRx as its leading partner for identification and early development of Israeli-sourced drug candidatesExclusive first look at all Israeli-based projects scouted by BioLineRxCo-develop selected projects through clinical proof-of-concept (POC)Unique collaboration provides lasting shareholder value and key insightsBuilds pipeline in conjunction with global leader, gaining Big Pharma perspectiveFinancial highlights:Upfront $10 million equity investment in BLRXUpon 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 
 

 *  Well Funded  Cash position~$39 million as of September 30, 2016Funds operational capital through beginning of 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 
 

 *  Principal Expected Development Milestones in 2017/2018  2018  2017  BL-8040 (Autologous SCM) phase 2/3 initiation   BL-8040 (Pancreatic Cancer) phase 2 partial results  BL-8040 (Allogeneic SCM) phase 2 partial results  BL-8040 (Allogeneic SCM) phase 2 completion  BL-8040 (AML Maintenance) phase 1b initiation  BL-8040 (Multiple Solid Tumors) phase 1b initiation  BL-8040 (Pancreatic Cancer) phase 2 top-line results  BL-8040 (AML Consolidation) phase 2b interim analysis  Does not include milestones expected from newly in-licensed programs  BL-8040 (AML Maintenance) phase 1b partial results  BL-8040 (Multiple Solid Tumors) phase 1b partial results 
 

 *  Philip SerlinChief Executive Officerwww.biolinerx.com +972-8-642-9100  Thank  You