Revelation Biosciences Receives Nasdaq Continued Listing Approval, Advances Gemini Program
Key Insights
Revelation Biosciences secured Nasdaq continued listing, contingent on maintaining a $1.00 stock price by February 14, 2025.
The company regained compliance with Nasdaq's Equity Requirement following a delisting notice in August 2024.
FDA accepted Revelation's Investigational New Drug (IND) application for Gemini, paving the way for Phase 1b trials.
Revelation Biosciences, Inc. (NASDAQ: REVB) announced that the Nasdaq Hearings Panel has granted the company continued listing on The Nasdaq Stock Market. This decision is contingent upon Revelation's stock trading at or above $1.00 for at least ten consecutive trading days by February 14, 2025.
Compliance and Future Plans
The Nasdaq Hearings Panel also confirmed that Revelation Biosciences has regained compliance with the Equity Requirement of Listing Rule 5550(b)(1). This follows a notice of delisting issued on August 14, 2024, for failure to comply with this equity requirement.
"We are very thankful to the Nasdaq Hearings Panel for recognizing the significant progress made following the tumultuous time for the Company post SPAC merger," said James Rolke, Chief Executive Officer of Revelation. "Now that our obligations from the SPAC merger have settled, we can focus on the development of Gemini and we look forward to the initiation of our Phase 1b clinical study in chronic kidney patients shortly."
Gemini Program Advancement
Revelation Biosciences recently achieved several milestones in the development of its Gemini program. On December 3, 2024, the company announced the successful exercise of warrants for $4 million. Prior to that, on December 2, 2024, the FDA accepted the Gemini IND application. The company anticipates initiating a Phase 1b clinical study in chronic kidney disease (search) patients in the first half of 2025. Revelation Biosciences has also successfully completed GMP manufacture of the Gemini drug product to support these clinical trials.
About Gemini
Gemini is an intravenously administered, proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®). It is designed to reduce inflammation-associated damage by reprogramming the innate immune system to respond to stress in an attenuated manner. Preclinical studies have demonstrated Gemini's therapeutic potential across several indications. Phase 1 clinical data for intravenous treatment with Gemini showed that the primary safety endpoint was met, with statistically significant pharmacodynamic activity observed through changes in biomarkers, including upregulation of IL-10.
Gemini is under development for multiple indications, including the prevention or reduction of acute kidney injury (search) (GEMINI-AKI program), the prevention or reduction of post-surgical infection (GEMINI-PSI program), and the treatment of chronic kidney disease (search) (GEMINI-CKD program).