Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 14

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 14
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 maintain a prospectus relating to the Common Stock issuable upon exercise of the 
 May 2025 Warrants and Pre-Funded Warrants, public holders will only be able to exercise    
 on a “cashless basis.”                                                                     |

| ● | We                                                                             
 may be required to repurchase the May 2025 Warrants.                           |
| ● | If                                                                             
 the May 2025 Warrants are exercised after a reverse stock split and/or a reset 
 of the exercise price stockholders will suffer substantial dilution.           |

Risks Related to our Diagnostic Product

| ● | The                                                                                 
 FDA could impose greater regulatory burdens on laboratory developed tests (“LDTs”). |

| ● | Delays                                                                                     
 or difficulties in the enrollment of patients could delay or prevent regulatory approvals. |

| ● | Clinical                                                         
 trials are expensive, time-consuming, and may not be successful. |

Risks Related to Our Diagnostic Tests

| ● | If                                                                                         
 our tests do not perform as expected, our operating results, reputation, and business will 
 suffer.                                                                                    |

| ● | We                                                                                            
 may experience difficulties that delay or prevent our development, introduction, or marketing 
 of enhanced or new tests.                                                                     |

| ● | Clinical                                                                                          
 testing of a particular diagnostic test or therapeutic product candidate may not yield successful 
 results.                                                                                          |

| ● | Even                                                                                      
 if our diagnostic tests or therapeutic products receive marketing approval, we may not be 
 successful in commercializing them.                                                       |

| ● | We                                                                   
 are currently dependent upon PPLS to offer and perform CyPath® Lung. |

| ● | If                                                                                             
 we cannot convince physicians of the benefits of our diagnostic tests or therapeutic products, 
 market acceptance could be delayed.                                                            |

| ● | We                            
 face substantial competition. |

| ● | Our                                                                                        
 success depends upon our ability to retain key executives and attract and retain qualified 
 personnel.                                                                                 |

| ● | Our                                                                      
 lack of operating experience may make it difficult to manage our growth. |

| ● | We                                                                                        
 will depend on third parties to manufacture and market our diagnostic tests and to design 
 trial protocols and monitor clinical trials.                                              |

| ● | We                                                                              
 are exposed to product liability and pre-clinical and clinical liability risks. |

| ● | Our                                                                                               
 failure to comply with privacy and security regulations could result in liability or reputational 
 harm.                                                                                             |

| ● | Our                                                                                        
 ability to obtain adequate reimbursement for our diagnostic tests may impact our revenues. |

| ●