Company: BIAF
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023405
Chunk: 89

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part II, Item 3
Chunk 89
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 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 of new diagnostic and therapeutic products;

28

    ●
    Expand
    commercialization of CyPath® Lung as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and
    CAP and/or, if and when we obtain clearance from FDA for our CyPath® Lung test, to expand sales in accordance with
    FDA rules and regulations. 

    ●
    Develop
    and commercialize CyPath® Lung as a CE-marked test in accordance with the In Vitro Diagnostic Regulation (“IVDR”)
    of the European Union (“EU”);

    ●
    Conduct
    research studies resulting in scientific results required to successfully develop therapeutic products based on our discoveries that
    the knockdown of certain cell receptors results in cancer death without harm to healthy tissue;

    ●
    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, and appropriate standards required for the
    commercialization of our tests and products in countries in which we seek to sell our diagnostic test(s) and therapeutic product(s);

    ●
    Obtain
    the necessary regulatory approvals to market our diagnostic test(s) and therapeutic product(s);

    ●
    Secure
    the necessary personnel and infrastructure to support the development, commercialization, and marketing of our diagnostic test(s)
    and therapeutic product(s); and

    ●
    Develop
    strategic relationships to support development, manufacturing, and marketing of our diagnostic test(s) and therapeutic product(s).

Even
if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain the
research and development efforts, diversify our diagnostic tests and therapeutic product offerings, or even continue operations. A decline