Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 113

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 113
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We expect that a large percentage of our research and development
expenses 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, we are unable to estimate with any certainty the costs
we will incur in the continued development of motixafortide in our pipeline for commercialization. Clinical development timelines, the
probability of success and development costs can differ materially from expectations. We expect to continue to test motixafortide and
any other therapeutic candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials
for each such 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.

Our future research and development expenses will depend on the
clinical success of motixafortide in solid tumor indications and on other potential therapeutic candidates, 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.

62

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, and are eligible to participate, in the clinical  

  the duration of patient follow-up;                                                      
  whether the patients require hospitalization or can be treated on an outpatient basis;  

  the development stage of the therapeutic candidate; and  

  the efficacy and safety proﬁle of the therapeutic candidate.  

The lengthy process of completing clinical trials and seeking regulatory
approval for our therapeutic candidates requires expenditure of substantial resources.