Company: BIAF
Filing Date: 2025-05-07
Form Type: 424B4
Source: 0001641172-25-008977
Chunk: 12

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-07
Form: 424B4
Chunk 12
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 our obligations imposed by any intellectual property licenses with 
 third parties that we may need in the future, we could lose rights that are important to  
 our business.                                                                             |

| ● | We                                                                                       
 may need to obtain licenses of third-party technology that may not be available to us or 
 available to us on reasonable terms.                                                     |

| ● | Our                                                                      
 competitive position depends on protection of our intellectual property. |

| ● | Diagnostic                                                                         
 tests and therapeutic products we develop could be subject to infringement claims. |

| ● | We                                                                               
 may become involved in lawsuits to protect or enforce our intellectual property. |

| ● | If                                                                                         
 we are unable to protect our trade secrets, our business and competitive position could be 
 harmed.                                                                                    |

| ● | Changes                                                                             
 in patent law could impair our ability to protect our tests and product candidates. |

| ● | Our                                                                                                 
 patent protection could be reduced or eliminated for non-compliance with governmental requirements. |

| ● | Patent                                                                                     
 terms may be inadequate to protect our diagnostic tests or therapeutic product candidates. |

| ● | Issued                                           
 patents could be found invalid or unenforceable. |

| ● | If                                                                  
 we do not obtain patent term extension, our business may be harmed. |

| ● | We                                                                          
 enjoy only limited geographical protection with respect to certain patents. |

| ● | If                                                                                       
 our trademarks and trade names are not adequately protected, we may not be able to build 
 name recognition.                                                                        |

Risks Related to Government Regulations

| ● | Should                                                                                
 the FDA’s regulatory approach to LDTs change, our strategy may be adversely affected. |

| ● | Delay                                                                                     
 by or failure of the FDA to grant our request for de novo classification adversely affect 
 our business.                                                                             |

| ● | Failure                                                                             
 to comply with laws pertaining to LDTs or in vitro devices (“IVDs”) could adversely 
 affect our business.                                                                |

| ● | Third-party                                                                               
 licensors of our future therapeutic products may be unable to obtain regulatory approval. |

| ● | Failure                                                                                     
 to obtain regulatory approval in foreign jurisdictions would prevent our product candidates 
 from being marketed in those jurisdictions that deny approval.                              |

| ● | We                                                                           
 may never obtain approval or commercialize such products outside of the U.S. |

| ● | The                                                                                         
 impact of changes to healthcare policy and future healthcare reform legislation is unknown. |

Risks Related to Ownership of Our Common Stock and Warrants

| ● | Our                                                                                                
 failure