Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 30

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 30
---
 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 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 that could delay or prevent our ability to receive marketing authorization or commercialize our diagnostic and therapeutic technologies, including:

| ● | regulators                                                                                                                              
 or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial       
 at a prospective trial site;                                                                                                            |
| ● | we                                                                                                                                      
 may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols       
 with prospective trial sites;                                                                                                           |
| ● | clinical                                                                                                                                
 trials may produce negative or inconclusive results, and we may