Company: BIAF
Filing Date: 2025-05-07
Form Type: 424B4
Source: 0001641172-25-008977
Chunk: 27

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-07
Form: 424B4
Chunk 27
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| ● | the                                                                                                                                     
 cost of clinical trials may be greater than we anticipate; or                                                                           |
| ● | regulators                                                                                                                              
 may revise the requirements for approving our diagnostic or therapeutic technologies, or such requirements may not be as we anticipate. |

If we are required to conduct additional clinical trials or other testing beyond those that we currently contemplate, if we are unable to successfully complete clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, we may:

| ● | be                                                                            
 delayed in obtaining marketing approval;                                      |
| ● | not                                                                           
 obtain marketing approval at all, which would seriously impair our viability; |

| ● | obtain                                                                                                 
 marketing approval in some countries and not in others;                                                |
| ● | obtain                                                                                                 
 approval for indications or patient populations that are not as broad as we intend or desire;          |
| ● | obtain                                                                                                 
 approval with labeling that includes significant use or distribution restrictions or safety warnings;  |
| ● | be                                                                                                     
 subject to additional post-marketing testing requirements; or                                          |
| ● | have                                                                                                   
 the diagnostic test or therapeutic product removed from the market after obtaining marketing approval. |

| 12 |

Our product and test development costs will increase if we experience delays in clinical testing or marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned, will need to be restructured, or will be completed on schedule or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our diagnostic technology or allow our competitors to bring diagnostic tests and therapeutic products to market before we do, potentially impairing our ability to successfully commercialize our diagnostic and therapeutic technologies and harming our business and results of operations.

Risks Related to Our Diagnostic Tests

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

Our success depends on the market’s confidence that PPLS can provide reliable, high-quality clinical testing services. There is no guarantee that the accuracy and reproducibility that our CAP/CLIA clinical pathology laboratory has demonstrated to date will continue as its test volume increases. We believe that PPLS’ customers are likely to be particularly sensitive to test limitations and errors, including inaccurate test results. As a result, if PPLS does not perform its diagnostic services as expected, our operating results, reputation and business