Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 42

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 42
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Prior
to 2022, we had not generated any revenue. During the years ended December 31, 2024, and December 31, 2023, we generated revenue of approximately
$9.4 million and $2.5 million, respectively.

To
become and remain profitable, we must succeed in generating additional laboratory revenue in excess of our operating expenses and developing
and commercializing our diagnostic tests and therapeutic products that we expect will generate significant income in the planned timeframe.
This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials
of our diagnostic and therapeutic technologies, obtaining regulatory approval for our diagnostic and therapeutic technologies, manufacturing,
marketing, and selling any diagnostic tests and therapeutic products for which we may obtain regulatory approval, and establishing and
managing our collaborations at various phases of each diagnostic test and therapeutic product candidate’s development. We are in
the preliminary phases of these activities. We may never succeed in these activities and, even if we do, may never generate sufficient
income to achieve profitability.

To
become profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to:

    ●
    Develop,
    enhance, and protect our diagnostic tests and therapeutic products;

    ●
    Raise
    sufficient funding to support our diagnostic tests and therapeutic product development program(s);

    ●
    Complete
    pre-clinical testing;

    ●
    Work
    with our partners to expand commercialization of our first diagnostic test, CyPath® Lung, as an LDT under the CAP/CLIA
    guidelines and regulations administered by CMS and CAP;

    ●
    Obtain
    de novo classification from FDA for our CyPath® Lung as a Class II in vitro diagnostic

 22 

    ●
    Work
    with our partners to develop and commercialize our first diagnostic test, CyPath® Lung, as a CE-marked test in accordance
    with the IVDR of the EU;

    ●
    Synthesize,
    test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed by
    the Company;

    ●
    Develop
    and conduct human clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s);

    ●
    Develop
    and manufacture the test(s) and product(s) to FDA standards, appropriate EU standards