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SEC filings
6-K
BIOLINERX LTD. filed this Form 6-K on 08/11/2016
Entire Document
 

 
   
Year Ended December 31,
   
Six Months
Ended June 30,
   
Total Costs
Since Project
 
   
2013
   
2014
   
2015
   
2016
   
Inception
 
   
(in thousands of U.S. dollars)
 
BL-8040
   
3,910
     
4,698
     
7,045
     
3,905
     
20,281
 
BL-7010
   
1,905
     
3,756
     
1,657
     
435
     
8,587
 
BL-5010
   
251
     
1,282
     
400
     
42
     
4,111
 
Other projects
   
5,097
     
1,537
     
1,916
     
728
     
104,060
 
Total gross direct project costs
   
11,163
     
11,273
     
11,018
     
5,110
     
137,039
 
 
From our inception through June 30, 2016, we have incurred research and development expense of approximately $159.4 million. We expect that a large percentage of our research and development expense in the future will be incurred in support of our current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes and given the early stage of our preclinical product development projects, we are unable to estimate with any certainty the costs we will incur in the continued development of the therapeutic candidates in our pipeline for potential commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue to test our product candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each product candidate. If we are not able to enter into an out-licensing arrangement with respect to any therapeutic candidate prior to the commencement of later stage clinical trials, we may fund the trials for the therapeutic candidate ourselves.
 
While we are currently focused on advancing each of our product development projects, our future research and development expenses will depend on the clinical success of each therapeutic candidate, as well as ongoing assessments of each therapeutic candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which therapeutic candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
 
As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain therapeutic candidates or projects in order to focus our resources on more promising therapeutic candidates or projects. Completion of clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a therapeutic candidate.
 
The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:
 
· the number of sites included in the clinical trials;
 
· the length of time required to enroll suitable patients;
 
· the number of patients that participate in the clinical trials;
 
· the duration of patient follow-up;
 
· whether the patients require hospitalization or can be treated on an out-patient basis;
 
· the development stage of the therapeutic candidate; and
 
· the efficacy and safety profile of the therapeutic candidate.
 
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