Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 173

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 173
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 cash resources are sufficient to continue operations through April 2025. Our future is dependent
upon the ability to obtain financing and upon future profitable operations from the development of new business opportunities. There
can be no assurance that we will be successful in accomplishing these objectives. Without such additional capital, we may be required
to curtail or cease operations and be required to realize our assets and discharge our liabilities other than in the normal course of
business which could cause investors to suffer the loss of all or a substantial portion of their investment. WithumSmith+Brown, PC, our
independent registered public accounting firm for the fiscal year ended December 31, 2024, has included an explanatory paragraph in its
opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2024, indicating that
our current liquidity position raises substantial doubt about our ability to continue as a going concern.

We
have a limited operating history, which makes it difficult to evaluate our current business and future prospects.

We
are a company with limited operating history, and our operations are subject to all of the risks inherent in establishing a new business
enterprise. The likelihood of our success must be considered in light of the problems, expenses, difficulties, complications, and delays
frequently encountered in connection with the formation of a new business, the development of new technologies or those subject to clinical
testing, and the competitive and regulatory environment in which we will operate. To date, we have generated revenue from a limited market
launch of CyPath® Lung in Texas. There can be no assurance that we will be able to successfully expand our commercialization
efforts or that we will obtain the necessary regulatory approvals that will allow us to expand our marketing efforts. We may not be able
to maintain certification of CyPath® Lung as an LDT in accordance with CAP/CLIA guidance and regulations, or obtain approval
of our diagnostic tests in development by the CMS, the FDA, European Medicines Agency, or Chinese National Medical Products Administration.
Even if we do so and are also able to commercialize our diagnostic tests, we may never generate revenue sufficient to become profitable.
Our failure to generate revenue and profit would likely cause our securities to decrease in value or become worthless.

In
addition, while we anticipate generating continued revenue from PPLS, our CAP-accredited, CLIA-certified clinical pathology laboratory,
we do not expect to immediately derive profit from revenue from PPLS’ services. Once we