The Fort Worth Press - Revelation Biosciences Inc. Presents Additional Positive Data from Prime Clinical Study

SAN DIEGO, CA / ACCESS Newswire / March 30, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company focused on innovative solutions for acute and chronic disease, presented additional positive data analysis from the PRIME Study at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026) in San Diego (March 29 - April 1, 2026). Presented datademonstrated the capability of Gemini to normalize the hyperinflammatory state and restore immunocompetence up to 7 days after a single dose, in stage 3 and 4 chronic kidney disease (CKD) patients peripheral blood mononuclear cells. Gemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide, a toll-like receptor 4 agonist, in development for the treatment of acute and chronic inflammation-driven diseases such as acute kidney injury (AKI) and CKD.

In the PRIME study, a majority of patients (>85%) had at least one elevated cytokine predose and (>60%) of these patients had elevated inflammatory cytokines IL-1b and IL-6. Treatment with Gemini significantly reduced the number of elevated cytokines at all measured timepoints post-dose out to 7 days (p60%) of patients were also found to be non-responsive to stimulation (immunoparalysis) predose. Gemini significantly restored normal responsiveness to LPS stimulation (p

Acute and chronic inflammatory disease is driven by increased cytokine production, as a result of activation of innate immune cells. This dysregulation in cellular activity contributes to perpetuation and progression of disease. Data from the PRIME clinical study demonstrate that treatment with a single dose of Gemini can durably normalize inflammation at the cellular level, and restored immunocompetence.

"We are pleased to have had the opportunity to share our compelling clinical data for the treatment of inflammatory disease in this forum," said James Rolke, Chief Executive Officer of Revelation. "This engagement with key opinion leaders and health care providers treating AKI is another step in our effort to initiate our planned pivotal clinical study in AKI later this year."

About Gemini

Gemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD^®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI program) and Revelation intends to initiate a pivotal Phase 2/3 clinical study in AKI later this year. In addition to AKI, Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD program). Due to its unique biology, Gemini has the potential to be a treatment for any disease associated with dysregulated inflammation. The potential of Gemini has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two phase 1 clinical studies. See additional detail here.

About AKI

Acute Kidney Injury or AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also significantly impact other organs such as the brain, heart, and lungs. Severe AKI requiring dialysis significantly increases the likelihood of worse outcomes including longer time in an ICU, potential to develop chronic kidney disease, and death.

AKI is a major cause of morbidity and mortality, affecting more than 20% of all hospitalized patients and more than 50% of patients admitted to intensive care units. Renal replacement therapy (dialysis) is still the only therapeutic option in the treatment of the consequences of severe AKI and is required in approximately 20% of all critically ill patients. Despite the fact that these patients show high mortality rates, up to 40% of patients who survive such an episode develop chronic kidney disease or end-stage renal disease. As such, new therapies to treat AKI are urgently needed.

About Revelation Biosciences, Inc.

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on innovative solutions for acute and chronic disease using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including the treatment of acute kidney injury and chronic kidney disease. Gemini has the potential to treat any acute or chronic condition driven by dysregulated inflammation.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

Company Contacts

Mike Porter
Investor Relations
Porter LeVay & Rose Inc.
Email: [email protected]

Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: [email protected]

SOURCE: Revelation Biosciences, Inc.

View the original press release on ACCESS Newswire

S.Jordan--TFWP