Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 9

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 9
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| ● | 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.                                                      |

| ● | 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