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

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 11
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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 this Offering

| ● | Resales of our Common Stock in the public market                                     
 as a result of this offering may cause the market price of our Common Stock to fall. |

| ● | Investors who buy shares at different times will 
 likely pay different prices.                     |

| ● | This offering may cause the trading price of 
 our Common Stock to decrease.                |

| ● | Our management will have broad discretion over 
 the use of the net proceeds.                   |

Risks Related to our Diagnostic Product

| ● | The FDA could impose greater regulatory burdens on laboratory developed tests 
 (“LDTs”).                                                                     |

| ● | 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 PPLS to offer and perform CyPath® Lung.