Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 46

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 46
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are unable to precisely estimate when we will begin to generate significant profit from revenue, if ever, from PPLS’ services,
nor to estimate the amount of profit or revenue that will be generated or the expenses that will be incurred.

We
do not expect to immediately derive profit from revenue from PPLS’ services. Since its acquisition in September 2023, we have generated
$2.5 million in 2023 and $9.4 million in 2024 in revenue from PPLS. Once we begin to generate such profit, there is no guarantee that
it will be sufficient to realize the expected financial benefits of the acquisition. In addition, since we have limited experience operating
a clinical laboratory, we may not accurately estimate the expenses we will incur.

We
have a limited operating history operating a clinical laboratory, and the members of our management team have limited experience operating
a CAP-accredited, CLIA-certified laboratory, which may limit the ability of investors to make an informed investment decision.

We
began operating a clinical laboratory in September 2023. Previously, only our Chief Operating Officer, Xavier Reveles, had operated a
CAP-accredited, CLIA-certified clinical laboratory and therefore it may be difficult for investors to analyze our ability to successfully
operate a clinical laboratory. Our ability to generate revenue from the clinical laboratory will depend, in part, on our ability to attract
and maintain customers and on the amount spent by the customers on such services. If our laboratory fails to attract customers and operate
at sufficient capacity, our margins will suffer, and we may not be able to fund the costs we incur to operate it. The success of our
clinical laboratory will also depend, in part, on our ability to attract and retain an appropriately skilled and sufficient workforce
to operate the laboratory and our ability to comply with various quality standards and environmental, health and safety laws and regulations.

We
have insufficient results for investors to use to identify historical trends. Investors should consider our prospects in light of the
risk, expenses and difficulties we will encounter as an early-stage company with respect to operating a clinical laboratory. Our revenue
and income potential for the clinical laboratory is unproven and our business model is continually evolving. We are subject to the risks
inherent to the operation of a new business enterprise and cannot assure you that we will be able to successfully address these risks.

Risks
Related to our Diagnostic Product

Until
we secure FDA clearance for CyPath® Lung as a Class II