Company: REVB
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034584
Chunk: 117

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1A
Chunk 117
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 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 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 GEM-AKI, GEM-CKD, GEM-PSI, 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.