Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 15

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 15
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 not conduct the studies or our clinical trials in accordance with regulatory requirements
or with our trial design. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or
if their performance is substandard, we may be required to replace them or add more sites to the studies. Although we believe that there
are a number of other third-parties that we could engage to continue these activities, replacement of these third parties will result
in delays and/or additional costs. As a result, our efforts to obtain regulatory approvals for, and to commercialize, motixafortide and
any other therapeutic candidate that we may develop in the future may be delayed. The collaborators may also have relationships with other
commercial entities, some of whom may compete with us. If the collaborators assist our competitors, our competitive position may be harmed.

In addition, our ability to bring future products to market depends
on the quality and integrity of data that we present to regulatory authorities in order to obtain marketing authorizations. Although we
attempt to audit and control the quality of third-party data, we cannot guarantee the authenticity or accuracy of such data, nor can we
be certain that such data has not been fraudulently generated. The failure of these third parties to carry out their obligations would
materially adversely affect our ability to develop and market new products and implement our strategies.

We recently entered into
out-licensing arrangements with Gloria and Ayrmid and may in the future rely on additional out-licensing arrangements for late-stage development,
marketing or commercialization.

We recently entered into out-licensing arrangements with Gloria
and Ayrmid and may in the future rely on additionalout-licensing arrangements
for late-stage development, marketing or commercialization. Dependence on out-licensing arrangements subjects us to a number of risks,
including the risk that:

  we have limited control over the amount                                        

10

  a licensee may experience financial difficulties;  
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  a licensee may fail to secure adequate commercial                          
  supplies of our therapeutic candidate upon marketing approval, if at all;  
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  our future revenues depend heavily on the  

  business combinations or significant changes                                                                                    
  in a licensee’s business strategy may adversely affect the licensee’s willingness or ability to complete its obligations under  
  any arrangement with us;                                                                                                        
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