Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 43

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 43
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 of these materials. In the event of contamination or injury, PPLS could be held liable for
any resulting damages, and any liability could exceed its resources or any applicable insurance coverage it may have. Additionally, PPLS
is subject to, on an ongoing basis, federal, state, and local laws and regulations governing the use, storage, handling, and disposal
of these materials and specified waste products. The cost of compliance with these laws and regulations may become significant and could
have a material adverse effect on its, and therefore our, financial condition, results of operations, and cash flows. In the event of
an accident or if PPLS otherwise fails to comply with applicable regulations, it could lose its permits or approvals or be held liable
for damages or penalized with fines.

If PPLS is unable to successfully scale its operations to support demand for CyPath ®Lung, its business could suffer.

As test volume of CyPath Lung grows,
PPLS will need to continue to ramp up its testing capacity, implement increases in scale and related processing, customer service, billing
and systems process improvements, and expand its internal quality assurance program and technology platform to support testing on a larger
scale. PPLS will also need additional equipment and certified laboratory personnel to process higher volumes of our tests. We cannot assure
you that any increases in scale, related improvements, and quality assurance will be successfully implemented by PPLS or that equipment
and appropriate personnel will be available. As additional tests are developed, PPLS may need to bring new equipment on-line, implement
new systems, technology, controls and procedures, and hire personnel with different qualifications.

The value of CyPath Lung depends,
in large part, on PPLS’ ability to perform the tests accurately and on a timely basis and on its reputation for such timeliness
and accuracy. Failure to implement necessary procedures or to hire the necessary personnel could impact its ability to meet market demand.
There can be no assurance that it will be able to perform tests on a timely basis at a level consistent with demand, that its efforts
to scale its commercial operations will not negatively affect the quality of test results, or that it will be successful in responding
to the growing complexity of testing operations.

In addition, PPLS’ growth may place a significant
strain on its management, operating and financial systems, and its sales, marketing, and administrative resources. As a result of its
growth, PPLS’ operating costs may escalate even faster than