Highlights

  • The company selected Avance Clinical as contract research organization for the adaptive Phase 2/3 TITAN study of Gemini.
  • Revelation aims to begin enrolling acute kidney injury patients in the pivotal study by the end of 2026.
  • Cash and equivalents of US$11.5 million at 30 June 2026 are expected to fund operations through Q1 2027.
  • The board adopted a one-year stockholder rights plan on 10 July 2026 with a 10% ownership trigger.

Revelation Biosciences, Inc. (NASDAQ:REVB) is moving through the final preparations for the single pivotal study it needs to support a Marketing application for Gemini, its lead candidate for acute kidney injury (AKI).

The San Diego-based clinical-stage company named Avance Clinical on 19 August 2026 to run TITAN, an adaptive Phase 2/3 trial that it described as on track to begin later this year. In its second-quarter update on 6 August 2026, management said the focus remained on starting enrollment by year-end, while cash on hand is expected to last only into early 2027.

A Single-Study Path Agreed With the FDA

Gemini is a proprietary formulation of PHAD, a toll-like receptor 4 agonist that Revelation says has shown potential in preclinical models of AKI, chronic kidney disease and infection, as well as in two Phase 1 studies.

In January 2026, the company reported agreement with the US Food and Drug Administration that positive data from one well-controlled Phase 2/3 adaptive study would be sufficient to submit a New Drug Application for Gemini in AKI. The randomized, double-blind, placebo-controlled design involves about 300 patients. Part 1 compares dosing regimens against placebo, Part 2 tests the selected regimen in a Phase 3 setting, and the primary endpoint is a composite of death and/or the need for dialysis.

Spending Rises as Study Start-Up Advances

The net loss for Q2 2026 was US$3.3 million, or US$0.87 per share, compared with US$2.4 million a year earlier. Research and Development expenses rose to US$1.9 million from US$1.3 million, and general and administrative costs increased to US$1.7 million from US$1.1 million. For the first half, the net loss attributable to common stockholders was US$12.0 million, including US$5.7 million of deemed dividends.

Cash and equivalents rose to US$11.5 million at 30 June 2026 from US$10.7 million at the end of 2025, mainly reflecting net proceeds from a January 2026 Warrant inducement. The company expects that cash to fund operations through Q1 2027. Beyond AKI, Revelation is also developing Gemini programs in chronic kidney disease, severe burns and post-surgical infection prevention.

Governance Measures and the Road to Enrollment

On 10 July 2026, the board adopted a stockholder rights plan that can be triggered when a person acquires 10% or more of the common stock without board approval, or 15% for qualifying passive investors. The rights expire after one year unless stockholders ratify the plan. Stockholders had earlier authorized, at the 24 June 2026 annual meeting, one or more reverse stock splits within a year at ratios between one-for-two and one-for-250, at the board's discretion.