Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company dedicated to developing novel therapies aimed at rebalancing inflammation to optimize health, announced today that the Nasdaq Stock Market LLC (“Nasdaq”) has formally notified the Company that its common stock will continue to be listed and traded on Nasdaq. This decision follows Revelation’s successful compliance with all Nasdaq listing requirements.
Revelation’s leadership emphasized the significance of maintaining its listing on Nasdaq, highlighting the benefits it brings to the company, its shareholders, and its overall mission.
“We believe being listed on Nasdaq helps us maintain liquidity for our stockholders, gives us access to capital, and allows us to attract and retain the people we need to accomplish our research and drive our company forward in 2025 and beyond,” said James Rolke, Chief Executive Officer of Revelation. “This listing supports our vision of creating a robust, high-value company committed to scientific excellence and innovation.”
Commitment to Innovation and Growth
The continued Nasdaq listing is a pivotal moment for Revelation Biosciences as it advances its clinical programs, including the recently launched PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of Gemini. Gemini is an intravenously administered investigational therapy designed to harness the power of trained immunity for disease prevention and treatment. Revelation’s proprietary formulation is currently under investigation for multiple indications, including chronic kidney disease (CKD), prevention of post-surgical infections, and acute kidney injury.
On January 21, 2025, Revelation announced the commencement of the PRIME Phase 1b clinical study, which evaluates escalating doses of Gemini in patients diagnosed with Stage 3 and Stage 4 CKD. This U.S.-based multi-site, placebo-controlled study aims to enroll up to 40 patients across five cohorts, each receiving a single escalating dose of the investigational drug.
“We are excited to start dosing patients in the PRIME study,” Rolke added. “This trial marks an important step in our journey to develop innovative therapies that address unmet medical needs. We are eager to monitor the progress of this study and share the results with our shareholders at every milestone.”
Understanding Gemini and Its Potential Applications
Revelation Biosciences is dedicated to developing therapies that leverage the body’s immune system to combat diseases and improve overall health outcomes. Gemini, the company’s proprietary formulation, is designed to modulate trained immunity, a concept that involves enhancing the immune system’s ability to recognize and respond to pathogens more effectively.
Current research efforts focus on three primary applications of Gemini:
- Chronic Kidney Disease (CKD) – CKD is a progressive condition characterized by a gradual loss of kidney function over time. Patients with advanced-stage CKD (Stages 3 and 4) face a significantly higher risk of cardiovascular disease and kidney failure. By stimulating the immune system and reducing inflammation, Gemini has the potential to slow disease progression and improve patient outcomes.
- Post-Surgical Infection Prevention – Surgical site infections (SSIs) are a major concern in healthcare, leading to prolonged hospital stays, increased healthcare costs, and higher patient morbidity. Gemini is being studied as a preventative measure to reduce the incidence of SSIs by priming the immune system before surgery.
- Acute Kidney Injury (AKI) Prevention – AKI is a sudden decline in kidney function, often resulting from infections, trauma, or medication toxicity. Revelation is exploring Gemini as a prophylactic treatment to prevent AKI in high-risk patients, particularly those undergoing major surgeries or receiving nephrotoxic medications.
Strategic Vision and Future Outlook
Revelation Biosciences continues to prioritize innovation and clinical development, focusing on areas with high unmet medical needs. The company’s leadership has outlined a strategic plan aimed at accelerating growth, securing additional funding, and expanding its research pipeline.
“We are committed to building a company that is not only financially sound but also scientifically groundbreaking,” said Rolke. “Our Nasdaq listing is a key component of our strategy, as it provides credibility, visibility, and access to institutional investors who share our long-term vision. By continuing to execute on our clinical programs and demonstrating the potential of Gemini, we aim to position Revelation as a leader in immune-based therapies.”
To support its ongoing research and development efforts, Revelation is actively exploring partnerships with leading academic institutions, biotech firms, and pharmaceutical companies. These collaborations will be instrumental in advancing Gemini through clinical trials and bringing it closer to regulatory approval.
Regulatory and Clinical Milestones
Revelation Biosciences has established a clear roadmap for achieving key regulatory and clinical milestones in 2025 and beyond. The PRIME Phase 1b study represents just the beginning of a broader clinical development plan, with subsequent phases aimed at further evaluating Gemini’s safety, efficacy, and mechanism of action.
Key anticipated milestones include:
- Completion of Phase 1b PRIME Study – Initial results from the study will help determine the optimal dosing regimen and safety profile of Gemini in CKD patients.
- Phase 2 Clinical Trials – Pending successful Phase 1b results, Revelation plans to initiate Phase 2 trials to assess Gemini’s efficacy in a larger patient population.
- Regulatory Engagement – Ongoing discussions with the U.S. Food and Drug Administration (FDA) will guide the next steps in the clinical development process, including potential Fast Track or Breakthrough Therapy designations.
Investor and Stakeholder Engagement
Revelation remains committed to maintaining transparency and open communication with its investors, stakeholders, and the broader scientific community. Regular updates on clinical progress, financial performance, and corporate developments will be provided through investor calls, press releases, and scientific conferences.
For more information on Revelation Biosciences, Inc. and its ongoing clinical programs, please visit www.RevBiosciences.com.
About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease. The company’s lead asset, Gemini, is being investigated across multiple indications, including chronic kidney disease, post-surgical infection prevention, and acute kidney injury prevention. Revelation is dedicated to advancing innovative therapies that address significant unmet medical needs and improve patient outcomes worldwide.
