Company: REVB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0000950170-25-066897
Chunk: 13

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part II, Item 1A
Chunk 13
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Item 1A. Risk Factors.

Our business is subject to various risks, including those described below and in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024.

Significant reductions in FDA staffing and changes in federal regulatory policy may delay or adversely affect the approval and commercialization of our product candidates.

Recent actions by the current administration, including substantial reductions in the workforce of the U. S. Food and Drug Administration (“ FDA”), have created increased uncertainty regarding the timing and outcome of regulatory reviews for new drugs and biologics. These staffing cuts, which have affected key divisions responsible for the review of innovative therapies, may result in longer review times, missed milestones, and inconsistent or delayed feedback from the agency. In addition, the loss of experienced FDA personnel and potential further restructuring could lead to a loss of institutional knowledge and a reduced ability to resolve complex regulatory questions efficiently.

As a result, we may experience delays in the initiation, conduct, or completion of our clinical trials and in the review and approval of our marketing applications. These delays could adversely impact our ability to bring our product candidates to market, disrupt our development timelines, and increase our costs. Furthermore, ongoing regulatory uncertainty may negatively affect investor confidence and our ability to raise additional capital on favorable terms, particularly as small and mid-cap biopharmaceutical companies are more vulnerable to such disruptions.

If the FDA’s operational capacity continues to be reduced or if further policy changes are implemented that affect the agency’s review processes, our business, financial condition, and results of operations could be materially and adversely affected.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.