Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 25

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 25
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 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 result in increased
development costs, which would cause the value of our Company to decline and limit our ability to obtain additional financing.

Clinical trials are expensive, time consuming, and may not be successful.

Clinical trials are expensive, time consuming, and
may not be successful. They involve the evaluation of diagnostic tests and testing of potential therapeutic agents and effective treatments
in humans to determine the safety and efficacy of the diagnostic tests and therapeutic products necessary for an approved diagnostic and
therapeutic technology. Many tests and products in human clinical trials fail to demonstrate the desired safety and efficacy characteristics.
Even if our tests and products progress successfully through initial or subsequent human testing, they may fail in later phases of development.
We may engage others to conduct our clinical trials, including clinical research