Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 23

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 23
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 FDA or other regulatory agencies could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. Moreover, during the conduct of clinical studies, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions. Drug-related, drug product-related, formulation-related and administration-related side effects could affect patient recruitment, the ability of enrolled patients to complete the clinical study or result in potential product liability claims, which could exceed the insurance coverage. Additionally, if one or more of our Program Products receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result. If we or others identify undesirable or unacceptable side effects caused by our Program Products or any future product candidates or products:

| ● | we may be required to modify, suspend or terminate our clinical 
 studies;                                                        |

| ● | we may be required to modify or include additional dosage                                                                                   
 and administration instructions, warnings and precautions, contraindications, boxed warnings, limitations, restrictions or other statements 
 in the product label for our approved products, or issue field alerts to physicians and pharmacies;                                         |

| ● | we may be required to conduct costly additional clinical 
 studies;                                                 |

| ● | we may be subject to limitations on how we may promote our 
 approved products;                                         |

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| ● | sales of our approved products may decrease significantly; |

| ● | regulatory authorities may require us to take our approved 
 products off the market;                                   |

| ● | we may be subject to regulatory investigations, government       
 enforcement actions, litigation or product liability claims; and |

| ● | our products may become less competitive, or our reputation 
 may suffer.                                                 |

Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we may publicly disclose preliminary or topline data from our clinical studies, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or studies. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the