Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 10

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 10
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  we, or any of our collaborators, may be                                                                            
  required to recall the product, change the way the product is administered or conduct additional clinical trials;  
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  additional restrictions may be imposed on                                      
  the marketing of, or the manufacturing processes for, the particular product;  
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  we, or any of our collaborators, may be                                          
  subject to fines, injunctions or the imposition of civil or criminal penalties;  
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  regulatory authorities may require the addition                                          
  of labeling or warning statements, such as a “black box” warning or a contraindication;  
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  we, or any of our collaborators, may be                                                                                                
  required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to physicians,  
  health care professionals and patients;                                                                                                
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  we could be sued and held liable for harm  

  physicians and patients may stop using our  
  product; and                                
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  our reputation may suffer.  
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Any of these events could harm our business and operations and
could negatively impact the market price of our ordinary shares and/or ADSs.

7

If we or our licensees are unable to obtain and/or maintain U. S. and/or foreign regulatory
approval for our therapeutic candidates in a timely manner or at all, we will be unable to commercialize our therapeutic candidates.

While we recently shut down our independent commercialization activities
in the United States and refocused our operations on development activities in Israel in the fields of oncology and rare diseases, we
continue to advance the development of motixafortide in solid tumors for all territories other than Asia. Motixafortide and any other
therapeutic candidate we develop will require additional, time-consuming and costly development efforts, by us or by our collaborators,
prior to commercial sale, including preclinical studies, clinical trials and approval by the FDA and/or applicable foreign regulatory
authorities. All therapeutic candidates are prone to the risks of failure that are inherent in pharmaceutical product development, including