Company: BIAF
Filing Date: 2025-04-15
Form Type: DRS
Source: 0001641172-25-004915
Chunk: 31

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-15
Form: DRS
Chunk 31
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 will not achieve our goals. We may have to abandon a test in which we have invested substantial resources. In order to successfully commercialize tests that we may develop in the future, we may need to conduct lengthy, expensive clinical trials and develop dedicated sales and marketing operations or enter into collaborative agreements to achieve market awareness and demand. Any delay in the research and development, approval, production, marketing, or distribution of enhanced or new tests could adversely affect our competitive position, branding, and results of operations.

We cannot be certain that:

| ● | any                                                                                    
 tests that we may enhance or develop will prove to be effective in clinical trials;    |
| ● | we                                                                                     
 will be able to obtain, in a timely manner or at 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