ACCESS Newswire·May 11, 2026, 9:00 AM ET

Revelation Biosciences, Inc. Releases Corporate Update Letter to Stockholders

REVB

Revelation Biosciences, Inc. released its 2026 annual meeting proxy materials & a corporate update letter from CEO James Rolke on May 11, 2026.
The FDA agreed in December 2025 that positive data from a single Phase 2/3 adaptive design study of approximately 300 patients can support a New Drug Application for Gemini to treat acute kidney injury (AKI).
The adaptive design study aims to reduce development time & costs by compressing the Phase 2 to Phase 3 transition from over a year to mere days.
Revelation plans to initiate the adaptive design clinical study in the fourth quarter of 2026 after establishing a scientific advisory board, engaging a specialized clinical research organization, completing nonclinical studies, & manufacturing drug product.
Gemini, a TLR4 agonist, works by stimulating cytokine production to rebalance inflammation without suppressing the immune system.
Preclinical & Phase 1b PRIME study data show Gemini significantly reduces inflammation & restores immunocompetence in AKI & chronic kidney disease models.
AKI affects over 10% of hospitalized patients & 50% of ICU patients, with dialysis remaining the only current treatment for severe cases.
The potential market for Gemini in AKI is estimated at over $5 billion based on savings compared to standard dialysis care.
Future opportunities include treating chronic kidney disease, severe burn-related hyperinflammation, & post-surgical infections.
As of December 31, 2025, Revelation held $10.7 million in cash & cash equivalents, sufficient to fund operations into the first quarter of 2027.
Net cash used for operating activities decreased to $8.3 million in 2025 from $18.3 million in 2024, while net loss for the year dropped to $8.9 million from $15.0 million.
The reduction in net loss was primarily due to the resolution of the LifeSci Capital LLC judgment & related legal & settlement expenses.