Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 26

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 26
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 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, we may be unable to successfully develop or commercialize our Program Products. If we or any of our future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our Program Products, we may not be able to generate sufficient revenue to continue our business. 14 Disruptions at the FDA and other national and foreign government authorities caused by funding shortages or global health concerns, such as COVID-19, could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business. The ability of the FDA and comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes