Slide 1: Fourth Quarter/Full Year 2013 Earnings Presentation
Exhibit 1 Fourth Quarter/Full Year 2013 Earnings Presentation March 17, 2014
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: Lead Development Programs
LEAD DEVELOPMENT PROGRAMS AML ‘Stem ceil mobilization BL-7010 Celiac disease ADDITIONAL DEVELOPMENT PROGRAMS BL-5010 ‘Skin lesions BL-7040 Inflammatory bowel disease BL-9010 Severe asthma/ailerges PROGRAMS PARTNERED OR IN CO-DEVELOPMENT BL-1040 BL-8020 BL-8030 BL-9020 p, Cotlaboretae with JHL for Ch
Slide 4: Update on Operations and Lead Programs
Chief Executive Officer Kinneret Savitsky, Ph.D. Update on Operations and Lead Programs 4
Slide 5: BioLineRx Today
BioLineRx Today • Focused on Clinical Execution in Oncology and Immunology – Two lead in-house development programs: • BL-8040 for AML, stem cell mobilization and other hematological indications • BL-7010 for celiac disease – Very well financed to achieve significant clinical milestones • Building E
Slide 6: Annual Highlights
* Annual Highlights Progress in key clinical programs: BL-8040 (AML): Reported promising initial Phase 2 results; received Orphan Disease designation BL-8040 (Stem cell mobilization): Regulatory submission for Phase 1 trial; received Orphan Disease designation BL-7010: Commenced Phase 1/2 trial and
Slide 7: Slide 7
Slide 8: Lead Development Programs
LEAD DEVELOPMENT PROGRAMS 7
Slide 9: BL-8040: Best-in-Class CXCR4 Antagonist
BL-8040: BEST-IN-CLASS CXCR4 ANTAGONIST Advancing two distinct clinical programs: • Acute myeloid leukemia (AML) – Reported promising partial results from Phase 2 study: – Safe at all doses tested (0.5, 0.75 and 1mg/kg) – Substantial mobilization of cancer cells from bone marrow – Evidence for robus
Slide 10: BL-7010: Novel Gliadin Binding Polymer for Celiac Disease
BL-7010: NOVEL GLIADIN BINDING POLYMER FOR CELIAC DISEASE Exciting progress in a fast-growing market: • Initiated blinded Phase 1/2 study in celiac patients consisting of two parts • Completed single-administration dose escalation stage: – Escalation reached highest planned dose without limiting tox
Slide 11: BL-1040: First-in-Class Myocardial Implant
BL-1040: FIRST-IN-CLASS MYOCARDIAL IMPLANT FOR PREVENTION OF VENTRICULAR REMODELING FOLLOWING AMI • Under partnership with Bellerophon (f/k/a Ikaria); called Bioabsorbable Cardiac Matrix (BCM) • Pivotal CE Mark Registration trial progressing at full steam – Over 75 sites currently active in nine cou
Slide 12: Fourth Quarter and Full Year 2013 Financial Overview
Chief Financial & Operating Officer Philip A. Serlin, CPA, MBA Fourth Quarter and Full Year 2013 Financial Overview 11
Slide 13: Completed Significant Financing in early 2014
Completed Significant Financing in early 2014 • Raised $24.1 million in underwritten public offering of ADS’s • Roth Capital (lead) and Maxim (co-manager) • Included 1,260,000 ADS’s granted to cover over-allotment option • Significantly oversubscribed • Broadens U.S. institutional investor base • AD
Slide 14: Financial Overview
* Financial Overview (in USD at 31-Dec-13 exchange rate) Research and development Total R&D expenses decreased by $5.8 million, to $12.7 million in 2013 2013 includes $1.7 million one-time reversal of OCS liability “Normalized” R&D decreased by $4.1 million Decrease resulted primarily from: Lower ex
Slide 15: Slide 15
Slide 16: Financial Overview
Financial Overview (in USD at 31-Dec-13 exchange rate) • General and administrative • G&A decreased $0.2 million to $3.8 million in 2013 • Small decrease resulted primarily from one-time expense for professional services incurred in 2012 • Non-operating income • Non-operating income increased $0.1 m
Slide 17: Financial Overview
Financial Overview (in USD at 31-Dec-13 exchange rate) • Cash and burn rate information • Cash and short-term deposits amounted to $18.2 million at 31-Dec-13 • Net proceeds from financing in March 2014 were approximately $22.5 million • Our net burn rate is ~$12-13 million per year • Analyst Coverag
Slide 18: 2014 Major Milestones
2014 Major Milestones BL-9020 (Type 1 Diabetes) collaboration with JHL √ BL-7010 (Celiac Disease) phase 1/2 study update* √ BL-5010 (Skin Lesions) pivotal EU study initiation BL-8040 (Stem Cell Mobilization) phase 1 initiation BL-8040 (AML) phase 2 partial results* BL-7010 (Celiac Disease) phase 1/2
Slide 19: Thank You! Questions?
Bench1to Bedside ro Pattiner Tie _ —_ y x eer THANK YOU! QUESTIONS? BIOLINEFM ><