Revelation Biosciences (REVB) 38th Annual Roth Conference summary

Program overview and scientific rationale

• Lead program Gemini targets acute and chronic kidney injury using a proprietary PHAD formulation.

• Gemini modulates immune response by activating the TRIF pathway, promoting inflammation resolution.

• Mechanism leverages evolutionary biology to rebalance inflammation in disease states.

• Potential applications extend to a broad range of inflammatory diseases.

Clinical and preclinical data

• Phase I-B study in CKD patients showed normalization of inflammatory cytokines after Gemini treatment.

• Durable response observed, with effects lasting up to seven days after a single dose.

• Gemini restored immune responsiveness in CKD patients, indicating rebalancing rather than suppression.

• Preclinical models demonstrated reduced inflammation and collagen formation in acute kidney injury.

• Similar protective cytokine profiles observed in healthy animals, humans, and diseased models.

Regulatory and clinical development plans

• FDA agreed to a single adaptive phase II/III pivotal study design for Gemini in AKI.

• Composite endpoint of death and days on dialysis approved, providing an objective measure.

• Study will include four dosing arms, with adaptive design allowing efficient transition to phase III.

• Adaptive design reduces time and cost between study phases and allows for sample size recalculation.

• Study initiation planned for late Q4 2026, with U.S. sites and a strong advisory board.