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20-F
BIOLINERX LTD. filed this Form 20-F on 03/10/2016
Entire Document
 
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D. Property, Plant and Equipment
 
We are headquartered in Modi’in, Israel. Until June 2015, our headquarters were located in Jerusalem. The facility consists of 1,663 square meters (approximately 17,900 square feet) of space and lease payments are approximately $27,000 per month, including maintenance fees and parking. This facility houses both our administrative and research operations and our central laboratory. The central laboratory consists of approximately 380 square meters and includes an analytical chemistry laboratory, a formulation laboratory and a tissue culture laboratory. Our central laboratory is compliant with both cGMP and certified GLP, which allows us to manufacture therapeutic supplies for our current clinical trials. All of our employees are based in this facility.
 
ITEM 4A. UNRESOLVED STAFF COMMENTS
 
None.
 
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
 
You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this annual report.  The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.  Our actual results could differ materially from those discussed in the forward-looking statements.  Factors that could cause or contribute to these differences include those discussed below and elsewhere in this annual report, particularly those in “Item 3. Key Information Risk Factors.”
 
We are a clinical stage biopharmaceutical development company dedicated to identifying, in-licensing and developing therapeutic candidates that have advantages over currently available therapies or address unmet medical needs. Our current development pipeline consists of three main clinical therapeutic candidates: BL-8040, BL-7010 and BL-5010. In addition, we have three other therapeutic candidates in clinical and pre-clinical development. We generate our pipeline by systematically identifying, rigorously validating and in-licensing therapeutic candidates that we believe exhibit a relatively high probability of therapeutic and commercial success. Our strategy includes commercializing our therapeutic candidates through out-licensing arrangements with biotechnology and pharmaceutical companies and evaluating, on a case by case basis, the commercialization of our therapeutic candidates independently. Our focus is principally on the therapeutic areas of oncology and immunology. However, we may also in-license therapeutic compounds outside of these areas in connection with our strategic collaboration with Novartis, as well as to a limited extent for our independent pipeline as the opportunities arise.
 
Clinical Stage Pipeline
 
The following is a description of our three main clinical therapeutic candidates:
 
 
BL-8040 is a novel, short peptide that functions as a high-affinity antagonist for CXCR4, which we intend to develop for multiple cancer and hematological indications.
 
 
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In June 2013, we commenced a Phase 2 trial for the treatment of r/r AML, which is currently being conducted at five world-leading cancer research centers in the U.S. and at five premier sites in Israel.  In November 2015, we announced positive results from the dose escalation stage of this study, including clinical response data. Top-line results of the study are expected in the first quarter of 2016.
 
 
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In March 2015 we reported successful top-line safety and efficacy results from a Phase 1 safety and efficacy trial for the use of BL-8040 as a novel treatment for stem cell mobilization, which was conducted at the Hadassah Medical Center in Jerusalem. More comprehensive data from this study was reported at the European Hematology Association (EHA) Conference in June 2015. In October 2015, we held a “Type B” meeting with the FDA to discuss the next steps in the clinical development plan for stem cell mobilization. In December 2015, we announced the filing of regulatory submissions required to commence a Phase 2 trial at Washington University School of Medicine in St. Louis for use of BL-8040 in stem cell mobilization for allogeneic transplantation. The trial is expected to commence shortly after receipt of regulatory approval, anticipated in the first quarter of 2016.