Company: BIAF
Filing Date: 2025-09-18
Form Type: 424B3
Source: 0001493152-25-014066
Chunk: 11

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-09-18
Form: 424B3
Chunk 11
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 comparison of our financials to those of other public companies more difficult.

Summary of Risk Factors

Like any emerging growth company, we face significant risk factors that may impede our plans for successful commercialization of our diagnostic and therapeutic products. These risks are discussed in detail under the “Risk Factors” discussion beginning on page 7 of this prospectus.

The following summarizes the principal factors that make an investment in our Company speculative or risky, all of which are more fully described in the section below titled “Risk Factors.” This summary should be read in conjunction with the section below titled “Risk Factors” and should not be relied upon as an exhaustive summary of the material risks facing our business. The following factors could result in harm to our business, reputation, revenue, financial results, and prospects, among other impacts:

Risks Related to Our Financial Position

| ● | Our                                                                                           
 business plan relies upon our ability to obtain additional sources of capital and financing.  |
| ● | We                                                                                            
 must raise additional capital to fund our operations in order to continue as a going concern. |
| ● | Our                                                                                           
 limited operating history makes it difficult to evaluate our business and future prospects.   |
| ● | We                                                                                            
 are unable to precisely estimate when we will begin to generate significant profit from PPLS. |
| ● | We                                                                                            
 have limited experience operating a laboratory.                                               |

Risks Related to our Diagnostic Product

| ● | Delays                                                                                     
 or difficulties in the enrollment of patients could delay or prevent regulatory approvals. |
| ● | Clinical                                                                                   
 trials are expensive, time-consuming, and may not be successful.                           |

Risks Related to Our Diagnostic Tests

| ● | If                                                                                                                                    
 our tests do not perform as expected, our operating results, reputation, and business will suffer.                                    |
| ● | We                                                                                                                                    
 may experience difficulties that delay or prevent our development, introduction, or marketing of enhanced or new tests.               |
| ● | Clinical                                                                                                                              
 testing of a particular diagnostic test or therapeutic product candidate may not yield successful results.                            |
| ● | Even                                                                                                                                  
 if our diagnostic tests or therapeutic products receive marketing approval, we may not be successful in commercializing them.         |
| ● | We                                                                                                                                    
 are currently dependent upon our laboratory subsidiary, PPLS, to offer and perform CyPath® Lung.                                      |
| ● | If                                                                                                                                    
 we cannot convince physicians of the benefits of our diagnostic tests or therapeutic products, market acceptance could be delayed.    |
| ● | We                                                                                                                                    
 face