Company: REVB
Filing Date: 2025-05-23
Form Type: S-1/A
Source: 0001213900-25-047104
Chunk: 26

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-23
Form: S-1/A
Chunk 26
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 clinical studies needed to obtain 
 regulatory approval for commercialization;                                                                                                |

| ● | we may not be able to obtain regulatory authorization to                                                                             
 proceed with various clinical studies in the United States, and even if we are able to proceed with clinical studies, the regulatory 
 authorities may limit, delay, or put our clinical studies on hold;                                                                   |

| ● | we may not be able to obtain adequate evidence from our clinical 
 studies for our Program Products;                                |

| ● | the results of our clinical studies may not meet the level                                                                       
 of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for marketing approval; |

| ● | we cannot be certain of the number of types of clinical studies                                              
 and non-clinical studies that the regulatory agencies will require in order to approve our Program Products; |

| ● | the data from clinical studies conducted outside of the United States 
 may not be accepted by the FDA or other regulatory authorities;       |

| ● | patients in our clinical studies may suffer serious adverse                                                                           
 events for reasons that may or may not be related to our Program Products, which could delay or prevent further clinical development; |

| ● | the regulatory agencies may find deficiencies without manufacturing 
 processes or facilities;                                            |

| ● | the CROs, that we retain to conduct our clinical studies                                       
 may take actions outside of our control that materially adversely impact our clinical studies; |

| ● | the regulatory agencies may not approve the formulation,                                  
 labeling or specifications of our Product Candidates, or other future product candidates; |

| ● | the regulatory agencies may change their approval policies 
 or adopt new regulations;                                  |

| ● | if approved, our Program Products will likely compete with                                                                              
 products that may reach approval for the same indication or use prior to our Program Products, products that are currently approved and 
 the products that are currently marketed products; and                                                                                  |

| ● | we may not be able to obtain, maintain or enforce our patents 
 and other intellectual property rights.                       |

Of the large number of drugs and devices in development in the pharmaceutical industry, only a small percentage results in the submission of a marketing authorization to the FDA or comparable foreign regulatory authorities and even fewer are approved for commercialization. Furthermore, even if we do receive regulatory approval to market our Program Products, any such approval may be subject to limitations on the indicated uses or patient populations for which we may market the products. Accordingly, even if we are able to obtain the requisite financing to continue to fund our development programs,