Company: BIAF
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023405
Chunk: 81

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 7
Chunk 81
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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 September 30, 2025, we had an accumulated deficit of $65.4 million and $7.7 million cash on hand. As of October 29, 2025, our cash
and cash equivalents were $8.4 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.
Our business plan includes expansion for our commercialization efforts which will require additional funding. If we are unable to improve
our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon
our ability to generate revenue and raise capital from financing transactions. Without funding from the proceeds of a capital