Company: BIAF
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641172-25-024163
Chunk: 83

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 7
Chunk 83
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 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
in our value could also cause you to lose all or part of your investment.

We
must raise additional capital to fund our operations in order to continue as a going concern.

As
of June 30, 2025, we had an accumulated deficit of $60.4 million and $0.8 million cash on hand. As of August 14, 2025, our cash and cash
equivalents were $0.3 million. Despite our recent financings, we will need to raise further capital through the sale of additional equity
or debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support our future operations.