Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 177

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 177
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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;

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

    ●