Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 11

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 11
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forceable. |

| ● | If we do not obtain patent term extension, our business may be harmed. |

| ● | We enjoy only limited geographical protection with respect to certain patents. |

| ● | If our trademarks and trade names are not adequately protected, we may not 
 be able to build name recognition.                                         |

Risks Related to Government Regulations

| ● | Should the FDA’s regulatory approach to LDTs change, our strategy may 
 be adversely affected.                                                |

| ● | Delay by or failure of the FDA to grant our request for de novo classification 
 adversely affect our business.                                                 |

| ● | Failure to comply with laws pertaining to LDTs or in vitro devices (“IVDs”) 
 could adversely affect our business.                                        |

| ● | Third-party licensors of our future therapeutic products may be unable to 
 obtain regulatory approval.                                               |

| ● | Failure to obtain regulatory approval in foreign jurisdictions would prevent          
 our product candidates from being marketed in those jurisdictions that deny approval. |

| ● | We may never obtain approval or commercialize such products outside of the 
 U.S.                                                                       |

| ● | The impact of changes to healthcare policy and future healthcare reform legislation 
 is unknown.                                                                         |

Risks Related to Ownership of Our Common Stock and Warrants

| ● | Our failure to meet the listing requirements of The Nasdaq Capital Market 
 could result in a de-listing of our Common Stock.                         |

| ● | We do not expect to pay dividends in the foreseeable future. |

| ● | Our Common Stock market price may never exceed the exercise price of our 
 outstanding warrants.                                                    |

| ● | Holders of our warrants have no rights as stockholders until they exercise 
 their warrants.                                                            |

| ● | The provisions of our outstanding warrants could limit a warrant holder’s 
 ability to choose the judicial forum for disputes.                        |

| ● | The financial and operational projections that we may make from time to time 
 are subject to inherent risks.                                               |

| ● | Our stock price has fluctuated in the past, has recently been volatile, and 
 may be volatile in the future.                                              |

| ● | Our Common Stock has often been thinly traded. |

| ● | An investment in our Company may involve tax implications. |

| ● | Our ability to use our net operating loss carryforwards and certain other 
 tax attributes may be limited.                                            |

| ● | Our Board can designate classes of Preferred Stock without stockholder approval. |

| ● | Provisions in our corporate charter