Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 26

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 26
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 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 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;         |