Announcement • May 01
Revelation Biosciences, Inc., Annual General Meeting, Jun 24, 2026 Revelation Biosciences, Inc., Annual General Meeting, Jun 24, 2026. Location: zoom audio conference., United States Announcement • Jan 22
Revelation Biosciences, Inc. Reaches Agreement with FDA on Gemini Approval Pathway for ADA Revelation Biosciences, Inc. announced that the Company has reached agreement with the FDA on an approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI). The two key agreements were 1) a clinically relevant and objective composite endpoint comprising death and/or need for dialysis, and 2) positive data from a single well-controlled Phase 2/3 adaptive design clinical study, comprising approximately 300 patients, would be sufficient for submission of a new drug application (NDA). This agreement significantly advances Gemini toward becoming a paradigm altering treatment available for patients suffering from AKI, a significant unmet medical need. Revelation reached agreement with FDA on a single adaptive clinical study design with a clearly defined and achievable patient-centered endpoint. The advantage of an adaptive design Phase 2/3 study is the ability to transition rapidly from Phase 2 to Phase 3, with an opportunity to sufficiently power the Phase 3 portion of the study. Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation 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. 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 it may not fully enroll its 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 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 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 it is expected over which it will be completed. Announcement • Jul 16
Revelation Biosciences Inc. Completes Dosing of Patients in Prime Study Revelation Biosciences, Inc. announced dosing has been completed for the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney disease (CKD). As planned, a total of 5 cohorts were enrolled at 3 clinics in the United States. Several study data sets are expected during Third Quarter 2025: these will include safety parameters, changes in hematologic parameters, in vitro evaluation of the inflammatory response in peripheral blood mononuclear cells isolated from study participants, and multiple biomarkers of activity. 
