Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 32

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 32
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 all, regulatory approvals, if needed; |

| ● | any                                                                                                      
 tests that we may enhance or develop will be ordered and used by healthcare providers;                   |
| ● | any                                                                                                      
 tests that we may enhance or develop can be provided at acceptable cost and with appropriate quality; or |
| ● | any                                                                                                      
 of our tests can be successfully marketed.                                                               |

These factors and other factors beyond our control could delay the launch of enhanced or new tests.

If clinical testing of a particular diagnostic test or therapeutic product candidate does not yield successful results, we will be unable to commercialize that test or product candidate.

We must demonstrate the product safety and efficacy of our candidates for diagnostic tests and therapeutic products in humans through extensive clinical testing. Our research and development programs are at an early stage of development. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of any test or product, including the following:

| ● | the                                                                                                                                         
 results of pre-clinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical       
 trials;                                                                                                                                     |
| ● | safety                                                                                                                                      
 and efficacy results attained in early human clinical trials may not be indicative of results that are obtained in later clinical           
 trials;                                                                                                                                     |
| ● | after                                                                                                                                       
 reviewing test results, we may abandon projects that we might previously have believed to be promising;                                     |
| ● | we                                                                                                                                          
 or our regulators may suspend or terminate clinical trials because the participating subjects or patients are being exposed to unacceptable 
 health risks; and                                                                                                                           |
| ● | our                                                                                                                                         
 test or product candidates may not have the desired effects or may include undesirable side effects or other characteristics that           
 preclude regulatory approval or limit their commercial use if approved.                                                                     |

| 13 |

Even if our diagnostic tests or therapeutic products receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.

Even if our products receive marketing approval, if needed, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. If we do not generate significant product revenues, we may not become profitable. The degree of market acceptance of our products and tests, if approved for commercial sale, will depend on a number of factors, including:

| ● | their                                                                                                                                      
 efficacy, safety, and other potential