Company: BIAF
Filing Date: 2025-04-15
Form Type: DRS
Source: 0001641172-25-004915
Chunk: 15

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-15
Form: DRS
Chunk 15
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 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 to meet the listing requirements of The Nasdaq Capital Market could result in a de-listing 
 of our Common Stock.                                                                               |

| ● | We                                                        
 do not expect to pay dividends in the foreseeable future. |

| ● | Our                                                                                        
 Common Stock market price may never exceed the exercise price of our outstanding warrants. |

| ● | Holders                                                                            
 of our warrants have no rights as stockholders until they exercise their warrants. |

| ● | The                                                                                     
 provisions of our outstanding warrants could limit a warrant holder’s ability to choose 
 the judicial forum for disputes.                                                        |

| ● | The                                                                                              
 financial and operational projections that we may make from time to time are subject to inherent 
 risks.                                                                                           |

| ● | Our                                                                                        
 stock price has fluctuated in the past, has recently been volatile, and may be volatile in 
 the future.                                                                                |

| ● | Our                                        
 Common Stock has often been thinly traded. |

| ● | An                                                      
 investment in our Company may involve tax implications. |

| ● | Our                                                                                      
 ability to use our net operating loss carryforwards and