Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 172

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 172
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 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, 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 the value of our Company 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 our
operations. A decline in the value of our Company 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 December 31, 2024, we had an accumulated deficit of $53.6 million and $1.1 million cash on hand. For the year 2024, cash used in operations
was $7.1 million and net loss was $9.0 million. Despite raising an additional $1.4 million in gross proceeds in February 2025 through
a private placement offering, we may 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 raise or strategic relationship
or grant, management anticipates that our