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Revelation Biosciences Selects Avance Clinical as CRO for Titan Study
Revelation Biosciences announced that it has selected Avance Clinical, a full-service contract research organization, CRO, with global operations, to serve as the CRO for its Phase 2/3 adaptive-design Titan study for evaluating Gemini in patients with acute kidney injury, AKI. "The Company selected Avance Clinical following an extensive evaluation process," said James Rolke, Chief Executive Officer of Revelation. "Working closely with Avance, the Revelation team remains committed to starting this important study later this year."
Revelation Biosciences Confirms $94B Market Potential for Gemini
Revelation Biosciences announced results of an independent market assessment which identified a potential $94B total addressable market for Gemini, confirming the unmet medical need. "The analysis and feedback from key hospital leaders in the report reinforce our conviction in the potential market opportunity for Gemini as well as what it can do for patients and the hospitals treating them," said James Rolke, Chief Executive Officer, Revelation Biosciences.
Revelation Reports $8.9 Million Net Loss for 2025
As of December 31, 2025, Revelation had $10.7 million in cash and cash equivalents, compared to $6.5 million as of December 31, 2024. The increase in cash and cash equivalents was primarily due to net cash proceeds from the May 2025 public offering and the September 2025 warrant inducement, offset by cash used for operating activities. Based on current operating plans and projections, Revelation believes its current cash and cash equivalents are sufficient to fund operations into the first quarter of 2027. Net cash used for operating activities for the twelve months ended December 31, 2025 was $8.3 million, compared to net cash used for operating activities of $18.3 million for the same 2024 period. Net loss for the three months ended December 31, 2025 was $2.5 million, or $1.65 net loss per share, compared to a net loss of $1.7 million, or $59.76 net loss per share, for the same 2024 period. Net loss for the year ended December 31, 2025 was $8.9 million, or $14.35 net loss per share, compared to net loss of $15.0 million, or $1,052.16 net loss per share for the year ended December 31, 2024. The reduction of our net loss in 2025 from 2024 was primarily related to the LifeSci Capital LLC judgment expense and reimbursement of legal costs, clinical trial related settlement expenses with A-IR Clinical Research Ltd., and expenses in connection with the deferred underwriting commissions.
Revelation Biosciences Presents Positive Data for Gemini at International Conference
Revelation Biosciences presented additional positive data analysis from the PRIME Study at the International Conference on Advances in Critical Care Nephrology in San Diego. Presented data demonstrated 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 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 and CKD. In the PRIME study, a majority of patients had at least one elevated cytokine predose and 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 following a single dose of Gemini verses no significant change in placebo. In addition, a majority of patients were also found to be non-responsive to stimulation predose. Gemini significantly restored normal responsiveness to LPS stimulation and trended to improved responsiveness to HMGB1. No significant responses were observed for placebo.
Revelation Reaches FDA Approval Pathway Agreement for Gemini in Acute Kidney Injury Treatment
Revelation Biosciences has reached agreement with the FDA on an approval pathway for Gemini as a treatment for Acute Kidney Injury. The two key agreements were a clinically relevant and objective composite endpoint comprising death and/or need for dialysis, and 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. 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. The planned adaptive Phase 2/3 design will be a randomized, double-blind, placebo-controlled study, and will be comprised of two parts. Part 1 will evaluate different dosing regimens vs placebo and part 2 will be conducted as a Phase 3 study using the safest dosing regimen identified in part 1. Data from both part 1 and part 2 can be used in the primary and secondary endpoint analyses. The primary endpoint will be a composite of measures including death and/or the need for dialysis. Over the course of 2026, Revelation will continue to build the infrastructure required to successfully conduct this clinical study, including engagement of a top-tier clinical research organization specializing in hospital-based renal studies, establishing an expert panel of scientific advisors, and completing the manufacture of clinical drug supply. Revelation is working expeditiously toward initiating the Phase 2/3 study.
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