Company: BIAF
Filing Date: 2025-05-27
Form Type: 424B5
Source: 0001641172-25-012410
Chunk: 38

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-27
Form: 424B5
Chunk 38
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 receive, our marketing efforts are limited to marketing CyPath ®Lung as an LDT. We intend to launch a pivotal trial later this year in an effort to attain such clearance; however, there can be no assurance that the trial will have favorable results or that it will generate the results necessary to obtain such clearance.

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 United States, 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. |

| 8 |

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 organizations and government-sponsored agencies. These trials may not start or be completed as we forecast or may not achieve desired results.

We may experience numerous unforeseen events during, or as a result of, clinical trials