Biolinerx Ltd. · TASE:BLRX
Biolinerx — Corporate Update (March 2013)
12 slides from Biolinerx's corporate update, Mar 20, 2013
Slide 1: BL-1020: CLARITY Interim Analysis Results
BL-1020: CLARITY INTERIM ANALYSIS RESULTS
Slide 2: 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
Slide 3: Interim Analysis - General
Interim Analysis - General • Objective of interim analysis – To provide estimation on number of patients needed in order to reach statistical significance on cognition endpoints • Interim analysis based on 230 patients – Risk mitigation - make early go/no-go decision regarding continuation of trial
Slide 4: Procedure for Analysis
Procedure for Analysis • Establishment of independent Data Monitoring Committee (DMC) • Closed session (only DMC members) – Un-blinded analysis and sample size recommendations discussed within the DMC – DMC prepares final recommendations for management • Open session - DMC and BLRX management – Blin
Slide 5: Interim Analysis Recommendations
Interim Analysis Recommendations • Primary cognition endpoint cannot be reached with any reasonable number of patients in current study • Secondary cognition endpoints cannot be reached with any reasonable number of patients in current study • Several statistical parameters specified in the statisti
Slide 6: Next Steps
Next Steps • Discontinue CLARITY study – No additional patients will be enrolled in the trial • Perform complete analysis of un-blinded study data on all patients enrolled to date • Revise Company’s operating plan for 2013 – Company’s current cash balance is $28 million – New operating plan expected
Slide 7: Current Pipeline
Current Pipeline Will commence Phase I/II in April 2013
Slide 8: BioLineRx's Main Programs
BioLineRx’s Main Programs • BL-1040: First-in-class myocardial implant for prevention of ventricular remodeling post AMI – Classified as device by FDA and out-licensed worldwide to Ikaria, Inc. • Received $7 million upfront payment from Ikaria, Inc. • $10 million first milestone payment received in
Slide 9: BioLineRx's Main Programs (cont.)
BioLineRx’s Main Programs (cont.) • BL-8040: Short peptide for leukemia/other hematological cancers – Functions as high-affinity antagonist for CXCR4, a chemokine receptor directly involved in tumor progression, angiogenesis, metastasis and cell survival – Demonstrated excellent safety profile in Ph
Slide 10: BioLineRx's Main Programs (cont.)
BioLineRx’s Main Programs (cont.) • BL-8020: Small molecule for hepatitis C – Orally available treatment – Unique mechanism of action; synergistic with other therapies – Works on host; pan-genotypic – Completed pre-clinical development – Phase I/II clinical study expected to commence in April 2013;
Slide 11: 2013-14 Major Clinical Milestones
2013-14 Major Clinical Milestones
Slide 12: BIOLINEM ><
BIOLINEM ><