Company: BIAF
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641172-25-024163
Chunk: 89

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part II, Item 3
Chunk 89
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From
time to time, we are involved in various disputes and litigation matters that arise in the ordinary course of business. To date, we have
had no material pending legal proceedings, and we are not engaged in any legal proceedings that are expected, individually or in the
aggregate, to have a material adverse impact on our financial position or results of operations.

ITEM
1A. RISK FACTORS.

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 six months ended June 30, 2025, we generated revenue of approximately $3.1 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