REVELATION BIOSCIENCES, INC.

Current report

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

Current report

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.

Current report

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.

Current report

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.

Previous report

Item 1A. Risk Factors.

Previous report

If Revelation is not able to comply with the applicable continued listing requirements or standards of Nasdaq, Nasdaq could delist our common stock.

Previous report

The Company’s common stock and Public Warrants are listed on the Nasdaq Capital Market under the symbols “REVB” and “REVBW,” respectively.

Previous report

On October 16, 2024, the Company received the Minimum Bid Price Delist Letter from the Staff of Nasdaq notifying the Company that it was not in compliance with the Minimum Bid Price Requirement. Separate from and in addition to the Minimum Bid Price Delist Letter, as previously disclosed, on August 14, 2024, the Company received the Stockholders’ Equity Requirement Deficiency Letter from the Staff of Nasdaq notifying the Company that it was not in compliance with the Stockholders’ Equity Requirement, nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. By virtue of the Company’s financing activities during the third quarter, the Company satisfied the Stockholders’ Equity Requirement as of September 30, 2024; however, Nasdaq may require the Company demonstrate its ability to meet the Stockholder’s Equity Requirement through December 31, 2025.

Previous report

The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company has the right to appeal the Nasdaq Letters by requesting a hearing before an independent panel, which it filed on October 23, 2024. The hearing request stayed any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. However, there can be no assurance that the Company will receive any extension by the hearing panel and will ultimately regain compliance with all applicable requirements for continued listing. If Nasdaq delists the Company’s common stock or Public Warrants from trading on its exchange for failure to meet the listing standards such as the Stockholders’ Equity Requirement or Minimum Bid Price Requirement, we and our stockholders could face significant material adverse consequences including:

Previous report

reduced liquidity for Revelation’s securities;

Previous report

a determination that the Company’s common stock is a “penny stock” which will require brokers trading in the Company’s common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for Revelation’s securities;

Previous report

In the event a reverse stock split is required to maintain the Minimum Bid Price Requirement for continued listing on Nasdaq, the Company intends to undertake such a reverse stock split. Even if a reverse stock split is effected, there can be no assurance that the market price of the Company’s common stock will maintain the Minimum Bid Price Requirement. The market price of our common stock will continue to be based, in part, on our performance and other factors unrelated to the number of shares outstanding.

Previous report

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

Previous report

Item 3. Defaults Upon Senior Securities.

Previous report

Item 4. Mine Safety Disclosures.

Previous report

Item 5. Other Information.

Previous report

None.