Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 23

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 23
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 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.  |

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 will suffer. We may be subject to
legal claims arising from such limitations, errors, or inaccuracies.

We may experience difficulties that delay or prevent our development, introduction, or marketing of enhanced or new tests