Company: BIAF
Filing Date: 2025-04-15
Form Type: DRS
Source: 0001641172-25-004915
Chunk: 13

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-15
Form: DRS
Chunk 13
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 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. |

| ● | Our                                                                                      
 employees, consultants, partners, and vendors may engage in misconduct or other improper 
 activities.                                                                              |

| ● | Failure                                                                               
 to comply with healthcare laws and regulations could result in substantial penalties. |

| ● | We                                                                           
 face intense competition in the biotechnology and pharmaceutical industries. |

| ● | The                                                                             
 market for our proposed tests and products is competitive and rapidly changing. |

| ● | Healthcare                                                                         
 cost containment initiatives and the growth of managed care may limit our returns. |

| ● | Disruption                                                                     
 of internal information technology systems will adversely affect our business. |

| ● | Declining                                                                           
 general economic or business conditions may have a negative impact on our business. |

| ● | Global                                                                       
 climate change and related regulations could negatively affect our business. |

Risks Related to the Operation of a CAP/CLIA Laboratory

| ● | PPLS’                                                                                           
 operations depend upon the relationship of certain of our pathologists with existing customers