Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 33

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 33
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 future business
arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible
that governmental authorities will conclude that our business practices, including certain arrangements with physicians who receive stock,
warrants, or stock options as compensation for services provided to us, do not comply with current or future statutes, regulations, agency
guidance, or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be
in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject
to significant penalties, including civil, criminal, and administrative penalties, damages, fines, exclusion from U.S. government-funded
healthcare programs, such as Medicare and Medicaid, or similar programs in other countries or jurisdictions, disgorgement, imprisonment,
contractual damages, reputational harm, diminished profits, additional reporting requirements, and oversight if we become subject to a
corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the delay, reduction,
termination, or restructuring of our operations. Further, defending against any such actions can be costly and time consuming and may
require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that
may be brought against us, our business may be impaired. If any of the physicians or other providers or entities with whom we expect to
do business are found not to be in compliance with applicable laws, they may be subject to significant criminal, civil, or administrative
sanctions, including exclusions from government-funded healthcare programs and imprisonment. If any of the above occur, it could adversely
affect our ability to operate our business and our results of operations.

We face intense competition in the biotechnology and pharmaceutical industries.

The biotechnology and pharmaceutical industries are
intensely competitive. We face direct competition from U.S. and foreign companies focusing on diagnostic tests and pharmaceutical products,
which are rapidly evolving. Our competitors include major multinational diagnostic and pharmaceutical companies, specialized biotechnology
firms, and universities and other research institutions. Many of these competitors have greater financial and other resources, larger
research and development staffs, and more effective marketing and manufacturing organizations than we do. In addition, academic and government
institutions are increasingly likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors,
to market commercial tests or products based on technology developed at such institutions. Our competitors may succeed in developing or
lic