SAN DIEGO, CA — January 7, 2026 — Leads & Copy — Revelation Biosciences, Inc. (NASDAQ:REVB) has commenced GMP manufacturing of GEMINI and a placebo to provide the company with clinical drug supply for later-stage clinical studies.
According to James Rolke, Chief Executive Officer of Revelation, working with a global contract manufacturing organization is a crucial step in advancing Revelation’s pipeline and accelerating timelines for upcoming clinical programs.
The manufacture of the drug and placebo will facilitate randomized, double-blinded, placebo-controlled clinical studies, which is an integral part of the broader strategy to move Gemini toward approval.
In December 2025, Revelation met with the FDA to establish agency feedback and input into the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI). The company is currently awaiting the official meeting minutes.
Gemini, a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), is a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has demonstrated the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is being evaluated as a potential treatment for acute kidney injury (GEMINI-AKI program), chronic kidney disease (GEMINI-CKD program), hyperinflammation and infection associated with severe burn (GEM-PBI), and post-surgical infection (GEMINI-PSI program).
The potential of Gemini has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two phase 1 clinical studies.
Acute Kidney Injury (AKI), also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in the blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also significantly impact other organs, such as the brain, heart, and lungs. Severe AKI requiring dialysis significantly increases the likelihood of worse outcomes, including longer time in an ICU, the potential to develop chronic kidney disease, and death.
AKI affects more than 10% of all hospitalized patients and more than 50% of patients admitted to intensive care units. Renal replacement therapy (dialysis) is still the only therapeutic option in the treatment of the consequences of severe AKI and is required in approximately 20% of all critically ill patients. Up to 40% of patients who survive such an episode develop chronic kidney disease or end-stage renal disease.
Revelation Biosciences, Inc. is focused on rebalancing inflammation using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including the treatment of chronic kidney disease, prevention for post-surgical infection, and as a treatment for acute kidney injury.
Contact:
Mike Porter
Investor Relations
Porter LaVay & Rose Inc.
Email: mike@plrinvest.com
Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com
Source: Revelation Biosciences, Inc.
