Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 15

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 15
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 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. |

| ● | PPLS                                                                                           
 may be unable to maintain equipment or generate revenue when its equipment is not operational. |

| ● | If                                                                                         
 our sole laboratory facility becomes damaged or inoperable, loses its accreditation, or is 
 required to vacate the facility, PPLS’ ability to sell its products or provide diagnostic  
 assays and pursue its research and development efforts may be jeopardized.                 |

| ● | Disruption                                                                                 
 in the commercial courier delivery services used by PPLS to transport sputum samples could 
 harm its business.                                                                         |

| ● | Security                                                                                   
 breaches, data loss, and other disruptions could compromise sensitive information of PPLS’ 
 business.                                                                                  |

|