Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 13

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 13
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udies (i. e., we are not the study sponsor), we may have less control over these studies. We estimate that certain of our clinical trials
will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the testing, and
we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization
of our current or future therapeutic candidates, including, but not limited to:

  delays in securing clinical investigators  

  delays in obtaining institutional review                            

  slower-than-anticipated patient recruitment  

  negative or inconclusive results from clinical  

  unforeseen safety issues;  

  uncertain dosing issues;  

  an inability to monitor patients adequately  

  problems with investigator or patient compliance  

A number of companies in the pharmaceutical and biotechnology industries,
including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after
seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for our therapeutic candidates,
we do not know whether any Phase 3 or other clinical trials we or our licensees may conduct will demonstrate adequate efficacy and safety
to result in regulatory approval to market any therapeutic candidate. For example, we previously investigated the treatment of motixafortide
for acute myeloid leukemia, AML, and following an interim analysis of a Phase 2b trial in which the investigational arm of motixafortide
combined with cytarabine did not demonstrate a statistically significant effect in the study’s primary endpoint, we terminated the
study. Nevertheless, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML
and induction treatment. If later-stage clinical trials of any therapeutic candidate do not produce favorable results, our ability
to obtain regulatory approval for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on our
business, financial condition and results of operations.

Even if we obtain regulatory
approvals, motixafortide and any other therapeutic candidate that we may develop in the future will be subject to ongoing regulatory review
and if we fail to comply with continuing U. S. and applicable foreign regulations, we could lose those approvals and our business would
be seriously harmed.

Even if therapeutics we or any licensee develops receive regulatory
approval, we or any licensee, as applicable, will be subject to ongoing reporting obligations, and any approved products and