Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 63

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 63
---
 business depends upon licensing our therapeutic products to third-party pharmaceutical companies
that would obtain these regulatory approvals. The FDA can delay, limit, or deny approval of these product candidates for many reasons,
including:

| ● | the inability of our licensors to satisfactorily demonstrate that the product candidates have acceptable safety and efficacy profiles for the requested indication; |
| ● | the FDA’s disagreement with the trial designs of our licensors or the interpretation of data from preclinical studies or clinical trials;                           |

| 28 |

| ● | the population studied in the clinical trial may not be sufficiently broad or representative to assess safety in the full population for which we seek approval;                                  |
| ● | the licensors’ inability to demonstrate that clinical or other benefits of our product candidates outweigh any safety or other perceived risks;                                                   |
| ● | the FDA’s determination that additional preclinical or clinical trials are required;                                                                                                              |
| ● | the FDA’s non-approval of the formulation, labeling, or specifications of our product candidates;                                                                                                 |
| ● | the FDA’s failure to accept the manufacturing processes, drug product characteristics, or facilities of third-party manufacturers with which we or the third-party licensors contract; or         |
| ● | the potential for approval policies or regulations of the FDA to significantly change in a manner rendering clinical data related to any therapeutic product candidate insufficient for approval. |

Even if clinical testing approval of any regulatory
filing for our product candidates eventually is completed, the FDA may grant approval contingent on the performance of costly additional
post-approval clinical trials. The FDA may also approve our product candidates for a more limited indication or a narrower patient population
than the third party originally requested, and the FDA may not approve the labeling that we believe is necessary or desirable for the
successful commercialization of our product candidates. If the FDA requires the licensors to narrow the indications to smaller patient
subsets, the market opportunities for our product candidates, if approved, and the ability to generate revenues and royalties may be materially
limited. To the extent the licensors seeks regulatory approval in foreign countries, they may face challenges similar to those described
above with regulatory authorities in applicable jurisdictions.

Obtaining and maintaining regulatory approval of our diagnostic tests or therapeutic product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions. Failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates from being marketed abroad.

In addition to regulations in the U.S., to market
and sell our diagnostic tests and therapeutic