Biolinerx Ltd. · TASE:BLRX
Biolinerx — Investor Presentation (February 2019)
31 slides from Biolinerx's investor presentation, Feb 4, 2019
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: Offering Summary
Offering Summary 3 Issuer BioLineRx Ltd. (NASDAQ:BLRX; TASE:BLRX) Offering size $15 million Offering type Confidentially marketed public offering (CMPO) Securities offered American depositary shares (1 ADS = 1 ordinary share) and warrants to purchase ADSs Use of proceeds BL-8040 – complete phase 3 i
Slide 4: Our Mission
Our Mission Our mission is to become a leader in the development of novel therapeutics for the treatment of cancer 4
Slide 5: Who are We?
Who are We? 5 NASDAQ: BRLX Ticker / Exchange BLRX (NASDAQ) Headquarters Tel Aviv, Israel Market cap ~$70 million (25-Jan-19) Shares outstanding ~115 million Cash ~$35 million (30-Sep-18) Cash runway Through 1H 2020 Employees 45 (35 in R&D)
Slide 6: Investment Highlights
Investment Highlights 6 Multiple opportunities for value creation 8 mid-to-late stage clinical studies ongoing3-4 data readouts over next 12 monthsPhase 3 registrational topline data expected in 2020 Compelling valuation ~$70 million market cap~$35 million cash as of 3Q 2018Cash runway through 1H 20
Slide 7: A Diverse Pipeline Targeting Multiple Oncology Indications
A Diverse Pipeline Targeting Multiple Oncology Indications 7 PROJECT INDICATION PRE-CLINICAL PHASE 1 Stem-cell mobilizationr/r AML Consolidation AML Solid tumors CANCER BL-8040 AGI-134 Skin lesions other BL-5010 Maintenance AML Gastric cancer Pancreatic cancer Pancreatic cancer PHASE 3 REGULATORY AP
Slide 8: BL-8040 – Best-In-Class CXCR4 Antagonist for Multiple Oncology and Hematology Indications
BL-8040 – Best-In-Class CXCR4 Antagonist for Multiple Oncology and Hematology IndicationsFor treatment of solid tumors, AML and indications requiring hematopoietic stem cell transplantation
Slide 9: BL-8040 – A Best-in-Class CXCR4 Antagonist Targeting Multiple Indications
A 14-amino acid synthetic cyclic peptide, high-affinity CXCR4 antagonist with long receptor occupancy (>48 hours)CXCR4 is over-expressed in more than 70% of cancers and its high expression levels correlate with disease severity CXCR4 and its ligand CXCL12 (SDF-1) play a critical role in the traffick
Slide 10: Stem Cell Mobilization
Stem Cell Mobilization 10 BL-8040 in Stem Cell Mobilization
Slide 11: Significant unmet medical need in SCM
Significant unmet medical need in SCMMultiple apheresis sessions required50-70% of patients are poor mobilizersFor poor mobilizers, 1-4 daily injections of Mozobil on top of G-CSF are requiredBL-8040 potentially offers a more effective and convenient mobilization option for patientsRobust HSC mobili
Slide 12: GENESIS Phase 3 Study: Mobilization of HSCs in Multiple Myeloma Patients
GENESIS Phase 3 Study: Mobilization of HSCs for Autologous Transplantation in Multiple Myeloma Patients 12 Study designPart 1: Lead-in period - dose confirmation in up to 30 multiple myeloma patientsPart 2: Randomized placebo-controlled study in combination with G-CSF in 177 multiple myeloma patient
Slide 13: BL-8040 in AML
BL-8040 in AML BIOUING
Slide 14: BL-8040’s Potential Role in AML Treatment Landscape
BL-8040’s Potential Role in AML Treatment Landscape 14
Slide 15: BL-8040.01 Phase 1/2a Study in Relapsed/Refractory AML
BL-8040.01 Phase 1/2a Study: Encouraging Results in Patients with Relapsed/Refractory AML 15 CR, complete response; CRi, complete response with incomplete hematological recovery Study designDose escalation (0.5 to 2.0 mg/kg) with expansion cohort at 1.5mg/kg Phase 1/2a dose escalation/expansion stud
Slide 16: BLAST Phase 2b Study: Consolidation Therapy for AML
BLAST Phase 2b Study: Consolidation Therapy for AML Patients in First Remission Treatment: Two or three cycles (age-based) of high-dose Ara-C in combination with either BL-8040 or placebo 16 EndpointsRelapse free survival (RFS)Toxicity, safety and tolerability of BL-8040 in combination with high-dos
Slide 17: BL-8040 in Cancer Immunotherapy
BL-8040 in Cancer Immunotherapy
Slide 18: BL-8040 – Addressing Unmet Needs in Cancer Immunotherapy
BL-8040 – Addressing Unmet Needs in Cancer Immunotherapy Despite significant advances in cancer immunotherapy, material unmet needs remain:Improving efficacy of immunotherapy in “cold” tumors, such as pancreatic cancerIncreasing rates and durability of response to existing therapies such as anti-PD1
Slide 19: COMBAT Phase 2a study for BL-8040 + pembrolizumab
COMBAT Phase 2a study for BL-8040 + pembrolizumab (Keytruda®)Study in metastatic pancreatic cancerOpen-label multi-center studyCommenced Sep-16; top-line results of BL-8040-Keytruda combination announced Oct-18 Ongoing Collaborations with Global Pharma Companies Validate BL-8040’s Novel Mechanism of
Slide 20: COMBAT/KEYNOTE-202 Phase 2a Study in Advanced Pancreatic Cancer
COMBAT/KEYNOTE-202 Phase 2a Study in Advanced Pancreatic Cancer To assess the safety and efficacy of BL-8040 in combination with pembrolizumab (Keytruda) in patients with advanced pancreatic cancer 20 EndpointsObjective response rate according to RECIST 1.1 criteriaDisease control rateProgression-fr
Slide 21: COMBAT/KEYNOTE-202 Phase 2a Study – Dual Combination Results
COMBAT/KEYNOTE-202 Phase 2a Study – Dual Combination Results 21 34.5% for 29 evaluable patients showed disease control activity (response + stable disease): 40% reduction in tumor burden was seen in 1 patient with partial response 1.5-13% reduction in tumor burden was seen in 6 out of 9 patients wit
Slide 22: Encouraging Results – Comparison with Other Second Line Treatments
Encouraging Results – Comparison with Other Second Line Treatments 22 In a number of clinical studies, Keytruda alone has not demonstrated any activity in PDACThe COMBAT results show extended disease control and survival for combination of BL-8040+Keytruda, with a very good safety and tolerability p
Slide 23: Addition of Chemotherapy – Rationale and Design
Addition of Chemotherapy – Rationale and Design 23 Cytotoxic chemotherapy induces tumor death, reducing tumor burdenCytotoxic chemotherapy induces immunogenic cell death, leading to activation/expansion of new tumor-reactive T-cell clonesBL-8040 facilitates infiltration of T cells into tumor corePem
Slide 24: AGI-134 – Cancer Immunotherapy
AGI-134 – Cancer ImmunotherapyA universal anti-cancer vaccine with a unique mechanism of action
Slide 25: What is the Alpha-Gal and Anti-Gal story?
What is the Alpha-Gal and Anti-Gal story? 25 Xenotransplantation experiments in the 1980’s-90’s found that, when introduced to humans, the alpha-Gal-positive tissue was bound by pre-existing human anti-Gal antibodies, which were the main cause of the rejection of porcine heart valves AGI-134 coats t
Slide 26: AGI-134 – Mechanism of Action (APC)
AGI-134 – Mechanism of Action 26 (APC) AGI-134 directs pre-existing anti-Gal antibodies to the tumor and induces activation of multiple immune system effector arms against the patient’s own neoantigens
Slide 27: AGI-134: A unique MOA Among Intratumoral Agents
AGI-134: A unique MOA Among Intratumoral Agents Oncolytic viruses (e.g.: T-Vec) PAMPs(e.g.:TLR-9 and STING agonists) AGI-134 Injected tumor cells identified by naturally occurring pre-existing antibodies Antibody-bound tumor cells destroyed by activated CDC and ADCC Tumor neoantigens release by
Slide 28: Current Status - Outline of Ongoing Phase 1/2a Clinical Study
Current Status - High Level Outline of Ongoing Phase 1/2a Clinical Study 28 mCRC= metastatic colorectal cancerHNSCC= head & neck squamous cell carcinomaICI= immune checkpoint inhibitor Accelerated escalation monotherapy PART 1 PART 2 Monotherapy basket Combination - mCRC Combination - HNSCC AGI-134
Slide 29: Looking ahead
Looking ahead BIOUING
Slide 30: Recent Accomplishments and Upcoming Milestones
Recent Accomplishments and Upcoming Milestones Multiple opportunities for value creation 30 BL-8040 Partial results from Phase 2a COMBAT pancreatic cancer study (with Merck) 1Q 2018 BL-8040 Top-line results from Phase 2 allogenic stem cell mobilization (Auto SCM) study 2Q 2018 AGI-134 Initiation of
Slide 31: Key Takeaways
Key Takeaways 31 Multiple opportunities for value creation 8 mid-to-late stage clinical studies ongoing3-4 data readouts over next 12 monthsPhase 3 registrational topline data expected in 2020 Compelling valuation ~$70 million market cap~$35 million cash as of 3Q 2018Cash runway through 1H 2020 Sing