Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 28

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 28
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 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.

| 12 |

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. |

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