Revelation Biosciences Selects Avance Clinical as CRO for Phase 2/3 TITAN Study of Gemini in Acute Kidney Injury

• Revelation Biosciences, Inc. (NASDAQ: REVB), a San Diego-based clinical-stage life sciences company, has selected Avance Clinical, a full-service global CRO, to manage its Phase 2/3 adaptive-design TITAN study evaluating Gemini — a proprietary TLR4 agonist formulation — in patients with acute kidney injury, following an extensive CRO evaluation process.

• Avance Clinical will provide comprehensive clinical trial support spanning site identification and management, patient recruitment, safety monitoring, and data management and analysis, with the TITAN study targeted to begin enrollment in Q4 2026 under an FDA-agreed approval pathway that allows a single adaptive Phase 2/3 registration study with a composite primary endpoint of death and/or need for dialysis.

Revelation Biosciences, Inc. (NASDAQ: REVB), a clinical-stage life sciences company developing innovative solutions to treat acute and chronic disease, announced on August 19, 2026, from San Diego, California, that it has selected Avance Clinical as the contract research organization for its Phase 2/3 adaptive-design TITAN study. The study will evaluate Gemini, Revelation’s proprietary formulation of phosphorylated hexaacyl disaccharide — a TLR4 agonist — in patients with acute kidney injury, a condition affecting more than 2.3 million patients annually in the U.S. with no approved pharmacological treatments and a potential market estimated above $5 billion.

Avance Clinical was selected following an extensive CRO evaluation process and will provide comprehensive clinical trial management across the TITAN study, including site identification and management, patient recruitment, safety monitoring, and data management covering completeness, accuracy, and analysis. The CRO’s mandate spans the full operational infrastructure required to execute a randomized, double-blind, placebo-controlled adaptive Phase 2/3 study of approximately 300 patients in a hospital-based renal patient population — a therapeutically specialized setting that demands specific site network expertise and operational rigor distinct from outpatient trial settings.

The TITAN study is designed within an FDA-agreed regulatory framework established in January 2026, under which the agency confirmed that a single adaptive Phase 2/3 registration study with a clinically relevant composite primary endpoint — death and/or need for dialysis — plus positive data would be sufficient to support a New Drug Application for Gemini in AKI. Gemini is designed to stimulate TLR4 to rebalance excessive inflammation without suppressing immunity, triggering a cytokine array targeting multiple inflammatory pathways. Preclinical AKI models and a Phase 1b study in chronic kidney disease patients have shown reduced inflammation and restored immunocompetence, and an independent market assessment has estimated a potential total addressable market for Gemini exceeding $94 billion across its broader therapeutic applications.

Avance Clinical’s selection comes as the company has been building its Asia Pacific footprint — most recently announcing dedicated clinical operations in Singapore, Malaysia, and mainland China in June 2026 — and follows its 2026 Frost & Sullivan Global Company of the Year Recognition in the biotechnology CRO industry. The TITAN study engagement reinforces Avance Clinical’s growing presence in late-stage, pivotal CRO mandates for U.S.-listed biotech sponsors, where its GlobalReady delivery model — spanning Australia, New Zealand, Asia, North America, and Europe — supports the multi-regional site network requirements of adaptive design registration studies.

“The Company selected Avance Clinical following an extensive evaluation process. Both teams remain committed to initiating the TITAN study later this year.”

James Rolke, Chief Executive Officer, Revelation Biosciences