Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 21

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 21
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 assess whether the proceeds are being used appropriately.
It is possible that, pending their use, we may invest the net proceeds in a way that does not yield a favorable, or any, return for our
company. Our management’s judgment may not result in positive returns on your investment and you will not have the opportunity to
evaluate the economic, financial or other information upon which our management bases its decisions.

Risks Related to our Diagnostic Product

Until we secure FDA clearance for CyPath ®Lung as a Class II in vitro diagnostic, we may encounter physicians who will not order an LDT.

In order to market our CyPath Lung
as an IVD medical device, we must receive de novo classification from the FDA as a Class II in vitro diagnostic. Subject to obtaining
necessary financing, we intend to launch a pivotal trial later this year in an effort to attain such classification; however, there can
be no assurance that the trial will have favorable results or that it will generate the results necessary to obtain such classification.
Until such time as we receive de novo classification, which we may never receive, our marketing efforts are limited to the marketing
and sale of CyPath Lung as an LDT. Without clearance of CyPathLung by the FDA, some physicians may not
order the test.

| 10 |

If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical
trials if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the
FDA or similar regulatory authorities outside the U.S., such as the European Medicines Agency.

Patient enrollment is affected by many other factors,
including:

| ● | the severity of the disease under investigation;                                 |
| ● | the patient eligibility criteria for the study in question;                      |
| ● | the efforts to facilitate timely enrollment in clinical trials;                  |
| ● | our payments for conducting clinical trials;                                     |
| ● | the patient referral practices of physicians;                                    |
| ● | the ability to monitor patients adequately during the trial period; and          |
| ● | the proximity and availability of clinical trial sites for prospective patients. |

We are unable to forecast with precision our ability
to enroll patients. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays
and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may