Slide 1: Third Quarter 2013 Earnings Presentation
Exhibit 1 Third Quarter 2013 Earnings Presentation November 13, 2013
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: Pipeline
Ventricular remodeling post-AMI Skin lesions AML & other hematological cancers Inflammatory bowel disease (IBD) Hepatitis C (HCV) Celiac disease BIOLINEM ><
Slide 4: Update on Operations and Selected Programs
Chief Executive Officer Kinneret Savitsky, Ph.D. Update on Operations and Selected Programs 4
Slide 5: Highlights of BioLineRx's Quarterly Activities
Highlights of BioLineRx’s Quarterly Activities • Progress in key clinical programs: – BL-1040 - Recruitment on track for CE Mark registration trial – BL-5010 - On schedule to begin EU pivotal study by end of this year – BL-8040 - Partial phase 2 results expected by end of this year – BL-7010 - All a
Slide 6: Progress on Key Programs
PROGRESS ON KEY PROGRAMS 6
Slide 7: BL-1040: First-In-Class Myocardial Implant for Prevention of Ventricular Remodeling Following AMI
BL-1040: First-In-Class Myocardial Implant for Prevention of Ventricular Remodeling Following AMI Continued progress in pivotal trial: – Pivotal CE-mark registration trial continuing to progress at full steam – Over 55 sites recruiting (including 14 sites in the U.S.) – Approximately 306 patients in
Slide 8: BL-8040: Best-in-Class CXCR4 Antagonist for Treatment of Hematological Cancers
BL-8040: Best-in-Class CXCR4 Antagonist for Treatment of Hematological Cancers Substantial progress on many fronts: • Received orphan drug designation by FDA • Ongoing phase 2 study: • All eight sites now open • Memorial Sloan Kettering Cancer Center joined the study • Partial results to be announce
Slide 9: BL-5010: Novel Formulation for Non-Surgical Removal of Skin Lesions
BL-5010: Novel Formulation for Non-Surgical Removal of skin Lesions Positioned for Commercial Success: • Pivotal CE-mark study in seborrheic keratosis expected to begin by end of year • Submissions made to regulatory authorities in Germany; approval already granted by ethical committees • Study resu
Slide 10: BL-7010: Novel Gliadin Binding Polymer for Celiac Disease
BL-7010: Novel Gliadin Binding Polymer for Celiac Disease Great potential in a fast growing market: • Received all regulatory approvals to start phase 1/2 study by end of 2013 • 32-patients at world-leading site in Finland for celiac disease research • Single and repeated ascending dose study • Resu
Slide 11: HCV Programs
HCV Programs BL-8020: • Novel HCV therapy in midst of Phase 1/2 clinical trial • Primary endpoint of study is effect of 16- week combination therapy with Ribavirin and BL-8020 • Received USPTO patent BL-8030: • NS3/4A inhibitor - demonstrated high genetic barrier to development of resistant variant
Slide 12: Third Quarter 2013 Financial Overview
Chief Financial & Operating Officer Philip A. Serlin, CPA, MBA Third Quarter 2013 Financial Overview 12
Slide 13: Financial Overview (based on nine-month data)
Financial Overview (based on nine-month data) (in USD at 30-Sep-13 exchange rate) • Research and development • Total R&D expenses decreased $1.9 million to $11.3 million in 2013 period • 2013 includes $1.7 million one-time reversal of OCS liability • “Normalized” R&D decreased by $0.2 million • Decr
Slide 14: Financial Overview (based on nine-month data)
Financial Overview (based on nine-month data) (in USD at 30-Sep-13 exchange rate) • General and administrative • G&A increased $0.2 million to $2.8 million in 2013 period • Increase resulted primarily from one-time expense for professional services. • Non-operating income • Non-operating increased $
Slide 15: Financial Overview (based on nine-month data)
Financial Overview (based on nine-month data) (in USD at 30-Sep-13 exchange rate) • Cash and burn rate information • Cash and short-term deposits amounted to $20.3 million at 30-Sep-13 • Our burn rate is ~$12 million per year (~$1 million per month) • Cash expected to last into mid-2015, without reg
Slide 16: 2013-14 Clinical and Commercial Milestones
2013-14 Clinical and Commercial Milestones BL-7040 (IBD) phase II POC study results √ BL-8020 (HCV) phase I/II initiation √ BL-8030 (HCV) collaboration deal with Chinese √ √ BL-7010 (Celiac Disease) pilot study initiation BL-8040 (AML) partial results BL-5010 (Skin Lesions) pivotal EU study initiati
Slide 17: Questions?
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