Company: BIAF
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023405
Chunk: 80

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 7
Chunk 80
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1A, “Risk Factors,” contained in our 2024 Form 10-K. Except as disclosed below, there have been no material changes from
the risk factors disclosed in our 2024 Form 10-K.

Risks
Related to Our Financial Position

Our
business plan relies upon our ability to obtain additional sources of capital and financing. If the amount of capital we are able to
raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs, we may be
required to cease operations.

Prior
to 2022, we had not generated any revenue. During the nine months ended September 30, 2025, we generated revenue of approximately $4.6
million, and $9.4 million during the year ended December 31, 2024.

To
become and remain profitable, we must succeed in generating additional laboratory revenue 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 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 (“