Biolinerx Ltd. · TASE:BLRX
Biolinerx — Investor Presentation (December 2017)
41 slides from Biolinerx's investor presentation, Dec 5, 2017
Slide 1: Transforming science into medicine
Transforming science into medicine
Slide 2: Forward-Looking Statements
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 u
Slide 3: Corporate presentation
Corporate presentation BIOUING
Slide 4: Attractive investment case
Attractive investment caseStrong balance sheet$55 million (end Q3 2017)Significant upcoming milestones:Top line combination results from phase 2 COMBAT study in pancreatic cancerResults from initial lead-in period of phase 3 GENESIS study in SCMInterim analysis from phase 2b BLAST study in consolida
Slide 5: Main pipeline assets
Main pipeline assets 5 PROJECT INDICATION REGULATORY APPROVAL PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Stem-cell mobilization Consolidation AML Solid tumors CANCER BL-8040 AGI-134 Type 1 diabetes immunology BL-9020 Skin lesions other BL-5010 Maintenance AML Gastric cancer Non-small cell lung cancer Panc
Slide 6: 2017 achievements
2017 achievements BIOUING
Slide 7: Main Achievements in 2017
Main Achievements in 2017 Completed recruitment for phase 2a COMBAT study in pancreatic cancer (Merck collaboration) 3 phase 1b/2 studies initiated under the Genentech collaboration (pancreatic, gastric and AML)Reached understandings with FDA on phase 3 registrational study in autologous SCMAcquired
Slide 8: Clinical update on BL-8040 platform
Clinical update onBL-8040 platform
Slide 9: BL-8040 Clinical Program
WS BL-8040 Clinical Program REGULATORY PROJECT INDICATION Croner | | roc _— _ _ a isles ‘CANCER al-g040 stem-cell mobilization CC ———*D Consolidation AML eqD Maintenance AML EEE Gastric cancer ~zD Gone Non-smal cll lng cancer | Pancreatic cancer A, —— Pancreatic cancer a —____ € sp BIOLINE™><
Slide 10: BL-8040 for Stem-cell Mobilization
BL-8040 for Stem-cell Mobilization
Slide 11: Stem cell mobilization - Indications
Stem cell mobilization - Indications 11 Stem cell mobilization Autologous Haploidentical Allogeneic Phase 3 study- GENESIS: One dose of BL-8040 on top of G-CSF Phase 2 study to assess the effect of BL-8040 as a single agent for Allo and Haplo transplant Phase 1 study in Healthy volunteers of BL-8040
Slide 12: GENESIS Phase 3 - Mobilization of SC in Multiple Myeloma patients
GENESIS Phase 3 - Mobilization of SC for autologous transplant in Multiple Myeloma patients 12 G-CSF, granulocyte-colony stimulating factorClinicaltrials.gov. NCT0346529 Study designPart 1: Lead in period - dose confirmation in up to 30 Multiple Myeloma patientsPart 2: Randomized placebo controlled
Slide 13: GENESIS Study: Objectives
GENESIS Study: Phase 3 SCM in Multiple Myeloma patients 13 Objectives To demonstrate that the combination of BL-8040 + G-CSF is superior to G-CSF alone in… Primary The ability of mobilize > 6M CD34+ cells in up to 2 apheresis Secondary The ability to mobilize > 2M CD34+ cells in 1 apheresis Safety a
Slide 14: BL-8040 – Solid Tumors
BL-8040 – Solid TumorsMobilizing and promoting infiltration of immune cells and reducing immunosuppression in the tumor microenvironment
Slide 15: BL-8040 - Addressing unmet needs in cancer immunotherapy
BL-8040 - Addressing unmet needs in cancer immunotherapy Despite significant advances in cancer immunotherapy, material needs remain:Improving the efficacy of immunotherapy in “cold” tumors, such as pancreatic cancerIncreasing rates and durability of response to existing therapies such as anti-PD1 a
Slide 16: COMBAT study: Advanced Pancreatic Cancer
COMBAT study: Advanced Pancreatic Cancer A Phase 2a, multi-center, open-label study to assess the safety and efficacy of BL-8040 in combination with Pembrolizumab (Keytruda) in patients with advanced pancreatic cancer 16 Phase 2a open-label study in combination with Pembrolizumab (n=30): NCT02826484
Slide 17: COMBAT - Objectives
COMBAT-Objectives 17 Objectives To demonstrate that the combination of BL-8040 and Pembrolizumab… Primary Induces responses assessed as overall response (CR+PR) Secondary Prolongs the progression free survival (PFS) Prolongs the overall survival (OS) Safety and Tolerability Is safe and tolerable Oth
Slide 18: Participating Sites and PIs
Participating Sites and PIs Site City/Country PI Patients enrolled Beth Israel Deaconess MC Boston/US Manuel Hidalgo – study PI- 6 Rambam MC Haifa/Israel Ron Epelbaum 5 Tel Aviv Sourasky MC Tel Aviv/ Israel Ravit Geva 4 Sheba MC Ramat Gan/ Israel Talia Golan 4 Rabin MC Petach Tikva/Israel Solomon Sh
Slide 19: BL-8040 for Acute Myeloid Leukemia
BL-8040 for Acute Myeloid Leukemia
Slide 20: Acute Myeloid Leukemia - Treatment Lines
Acute Myeloid leukemia-Treatment Lines 20
Slide 21: Study BL-8040.01: Encouraging results in relapsed/refractory AML
Study BL-8040.01: Encouraging results in patients with relapsed/refractory AML 21 CR, complete response; CRi, complete response with incomplete hematological recovery; AML, Acute Myeloid Leukemia Study designDose escalation (0.5 to 2.0 mg/kg) with expansion cohort at 1.5mg/kg Phase 1/2a dose escalat
Slide 22: BL-8040.01 for Relapse/Refractory AML - Key Findings
BL-8040.01 for Relapse/Refractory AML-Key Findings 22 Population Relapsed or refractory AML patients including patients after allogeneic transplantation Primary Endpoint Safety and Tolerability BL-8040 was found to be safe and well tolerated in combination with high dose cytarabine Secondary endpoin
Slide 23: BL-8040.01 - Overall Survival in R/R AML patients
BL-8040.01- Overall Survival in R/R AML patients treated with BL-8040 +HiDAC 23
Slide 24: BLAST study: Consolidation therapy in AML
BLAST study: Consolidation therapy in AML patients in first remission Treatment: Two or three cycles (age-based) of consolidation with high-dose Ara-C together in combination with either BL-8040 or placebo 24 BL-8040 potentially offers AML patients prolonged remission and increased overall survival
Slide 25: BLAST - Objectives
BLAST-Objectives 25 Objectives To demonstrate that the combination of BL-8040 High Dose Cytarabine (HiDAC) Primary Prolongs the Relapse free survival Secondary Reduces the minimal residual disease (MRD) Prolongs the Overall survival Safety and Tolerability Is safe and tolerable.
Slide 26: BATTLE study – BL-8040 and Atezolizumab in AML
BATTLE study – Combination of BL-8040 and Atezolizumab in AML patients at a high risk of relapse A Phase 1b/2, multi-center, single arm, open-label study, to evaluate the safety and efficacy of BL-8040 in combination with Atezolizumab for maintenance treatment in AML patients of 60 years or older th
Slide 27: BATTLE - Objectives
BATTLE-Objectives 27 Objectives To demonstrate that the combination of BL-8040 and Atezolizumab… Primary Prolongs the relapse free survival (RFS) time as compared to historical data. Secondary Reduces the minimal residual disease (MRD) Prolongs the Overall Survival (OS) time as compared to historica
Slide 28: AGI-134: a novel immuno-oncology agent
AGI-134: a novel and unique immuno-oncology agent tackling the challenge of tumor neoantigen heterogeneity
Slide 29: AGI-134 – Harnessing pre-existing immunity
AGI-134 – Harnessing pre-existing immunity to deliver a patient-specific anti-tumor response 29 Tumors vary from patient to patient in their neoantigen load and identityAGI-134 is a universal drug that evokes a vaccine effect via a unique, hyperacute, multi-arm mechanism that targets patient-specifi
Slide 30: alpha-Gal and anti-Gal
alpha-Gal and anti-Gal 30 The alpha-Gal epitope is abundantly synthesized on glycolipids of non-primatesDue to constant exposure to this antigen (expressed by gut flora) humans develop and maintain high levels of anti-Gal Abs Xenotransplantation experiments in the 1980s-90s found that, when introduc
Slide 31: AGI-134 synthetic a-Gal glycolipid molecule
AGI-134 A fully synthetic a-Gal glycolipid molecule for intratumoral injection into solid tumors, to induce an immune response against a patient’s own neoantigens a-Gal linker phospholipid 31
Slide 32: AGI-134 – Mechanism of Action
AGI-134 – Mechanism of Action 32
Slide 33: Compelling Pre-Clinical Data Supports Phase I Study
Compelling Pre-Clinical Data Supports Phase I Study due 1H 2018 A single dose of AGI-134 into a primary tumor protected mice from secondary tumor development for more than 90 days Combination of AGI-134 with an immune checkpoint inhibitor (anti-PD-1) resulted in increased efficacy over either agent’
Slide 34: How is AGI-134 differentiated from competitors?
How is AGI-134 differentiated from competitors? Evokes personalized anti-tumor immunity Targets a multitude of patient-specific neoantigens Does not require complex ex vivo processing or computer modelling Harnesses pre-existing antibodies Directly labels the treated tumor for
Slide 35: High level outline of Phase 1/2a clinical study
High level outline of Phase 1/2a clinical study RP2D = Recommended Phase 2 Dose Study completion Accelerated escalation monotherapy Monotherapy Basket Part I Part II Combination – HNSCC RP2D Combination – mCRC Combination – STS AGI-134 AGI-134+ IO 35 mCRC = Metastatic Colorectal Cancer STS = Soft Ti
Slide 36: AGI-134 – Immune monitoring strategy
Treated and distal tumors:Level and composition of immune infiltrate & change with treatmentChanges in infiltrating T cell repertoire Changes in inflammatory signature Peripheral blood:Anti-Gal antibody titer and change with treatmentChanges in circulating T cell repertoireChanges in pro-inflammator
Slide 37: Looking ahead
Looking ahead BIOUING
Slide 38: Principal Milestones for 2017/2018
2017 2018 Principal Milestones for 2017/2018 38 BL-8040 (Allo SCM)Phase 2 partial results BL-8040 (Auto SCM)Lead-in results BL-8040 (Panc., Gastric, AML) Phase 1/2 initiation (Genentech) BL-8040 (pancreatic) Phase 2 initiation (MDACC) AGI-134Agalimmune acquisition BL-8040 (Allo SCM)Phase 2 top-line
Slide 39: Looking into the upcoming year
Looking into the upcoming year Multiple read-outs during 2018: COMBAT top line results , Phase 3 lead-in results and potential BLAST interim resultsContinue to lay foundations for future events: Phase 3 in SCM, AGI-134 initiation Company expecting to meet previously-stated timelinesExpecting continu
Slide 40: Long-term vision
Long-term vision BIOUING
Slide 41: BioLineRx in Five Years
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 revenuesP