Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 30

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 30
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 if the exercise price is reset to the floor price of $0.10, and you will suffer immediate and substantial dilution in the net tangible book value of the Common Stock you purchase in this offering or the Common Stock underlying the Pre-Funded Warrants you purchase in this offering.

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 novoclassification 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 novoclassification, which we may never receive, our marketing efforts are limited to the marketing and sale of CyPath ®Lung as an LDT. Without clearance of CyPath ®Lung by the FDA, some physicians may not order the test.

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. |

| 11 |

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