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

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 25
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 product candidate to be commercially available for years, if at all. Our Program Products are, and any future product candidate will be subject to strict regulation by regulatory authorities in the United States and in other countries. We cannot commercialize a product candidate or diagnostic device until the appropriate regulatory authorities have reviewed and approved such product candidate or diagnostic device. Even if our current or future Program Products meet safety and efficacy endpoints in pivotal clinical studies, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. 13 This may include approval of a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical studies and the review process. Our business depends on the success of our Program Products, including obtaining regulatory approval to market our product candidates in the United States and/or other major foreign markets such as the EU. We are focusing our time and financial resources in the clinical development of our product candidates. If we cannot successfully develop, obtain regulatory approval for, and commercialize our Program Products, we may not be able to continue our operations. The future regulatory approval and commercial success of our Program Products are subject to a number of risks, including the following:

| ● | we may not have sufficient financial and other resources                                                                                  
 to complete the necessary clinical studies for our Program Products, including, but not limited to, the 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