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

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 22
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 result in increased
development costs, which would cause the value of our Company to decline and limit our ability to obtain additional financing.

Clinical trials are expensive, time consuming, and may not be successful.

Clinical trials are expensive, time consuming, and
may not be successful. They involve the evaluation of diagnostic tests and testing of potential therapeutic agents and effective treatments
in humans to determine the safety and efficacy of the diagnostic tests and therapeutic products necessary for an approved diagnostic and
therapeutic technology. Many tests and products in human clinical trials fail to demonstrate the desired safety and efficacy characteristics.
Even if our tests and products progress successfully through initial or subsequent human testing, they may fail in later phases of development.
We may engage others to conduct our clinical trials, including clinical research organizations and government-sponsored agencies. These
trials may not start or be completed as we forecast or may not achieve desired results.

We may experience numerous unforeseen events during
or as a result of clinical trials that could delay or prevent our ability to receive marketing authorization or commercialize our diagnostic
and therapeutic technologies, including:

| ● | regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;                                                                                                              |
| ● | we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;                                                                                                                     |
| ● | clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product and test development programs;                                                                                 |
| ● | the number of patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;                                 |
| ● | our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;                                                                                                                                 |
| ● | we may have to suspend or terminate clinical trials for various reasons, including a finding that the participants are being exposed to unacceptable health risks;                                                                                                                     |
| ● | regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks; |

| 11 |

| ● | the cost of clinical trials may be greater than we anticipate; or                                                                                  |
| ● | regulators may revise