Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 65

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 65
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 that we are required to obtain premarket authorization for the software, our ability
to offer CyPath Lung as an LDT could be delayed or prevented, which would adversely affect our business.

The third-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval. The denial or delay of any such approval would delay commercialization of our future therapeutic products and have a material adverse effect on our potential to generate revenue, our business, and our results of operations.

We plan to license our therapeutic candidates to third
parties for development, including clinical testing, manufacturing, labeling, packaging, approval, promotion, advertising, storage, recordkeeping,
marketing, distribution, post-approval monitoring and reporting, and export and import. These activities that are to be undertaken by
third-party licensees of our future therapeutic products are subject to extensive regulation by the FDA and by foreign health authorities
in other countries. These regulations differ from country to country. In the U.S., we are not permitted to market our therapeutic product
candidates until we receive regulatory approval from the FDA. The process of obtaining regulatory approval is expensive, often takes many
years following research and development and thereafter the commencement of clinical trials, and can vary substantially based upon the
type, complexity, and novelty of the product candidates involved, as well as the target indications and patient population. Despite the
time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed. For our licensors to
gain approval to market our product candidates, they must provide clinical data that adequately demonstrate the safety and efficacy of
the product for the intended indication. We or any third party has not yet obtained regulatory approval to market any of our product candidates
in the U.S. or any other country. Our 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