Company: BIAF
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023405
Chunk: 96

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part II, Item 1A
Chunk 96
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In
addition to other information set forth in this Quarterly Report, you should carefully consider the “Risk Factors” discussed
in the 2024 Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described
in or implied by the forward-looking statements contained in this Quarterly Report. Additional risks and uncertainties not currently
known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition, and
operating results. The following information updates and should be read in conjunction with the information disclosed in Part I, Item
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