Revelation Biosciences (NASDAQ: REVB) began Good Manufacturing Practice (GMP) production of its lead candidate, Gemini, and a matching placebo on January 7, 2026. The manufacturing run will supply the drug needed for the company’s upcoming Phase 2 clinical studies and represents a key operational milestone for the clinical‑stage biopharma.
Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll‑like receptor 4 (TLR4) agonist that rebalances the innate immune response. The company is developing the drug for acute kidney injury (AKI), chronic kidney disease (CKD), surgical site infection, and burn‑related infection. GMP manufacturing is required to produce a compliant, scalable supply of the investigational product, thereby de‑risking the drug supply for the larger, resource‑intensive trials that will precede regulatory submission.
Revelation’s financial profile remains strong for a pre‑revenue company. It has no debt and a high current ratio of 6.92, giving it a solid cash runway to fund its development program. The company also met with the U.S. Food and Drug Administration in December 2025 to discuss the clinical development and regulatory pathway for Gemini in AKI, and it is awaiting the official meeting minutes. The GMP start is a tangible step forward that reduces a key operational risk and signals progress toward the next regulatory milestone.
James Rolke, Revelation’s CEO, said the partnership with a leading global contract manufacturing organization “is a critical step in advancing our pipeline and accelerating timelines for upcoming clinical programs.” He added that the FDA meeting in December had provided valuable feedback on the development strategy for AKI, reinforcing the company’s confidence in the clinical trajectory of Gemini.
The GMP manufacturing launch positions Revelation to move Gemini into Phase 2 trials, a prerequisite for eventual regulatory approval and commercialization. By securing a compliant supply chain, the company reduces a major operational risk and demonstrates progress that can strengthen investor confidence in its long‑term strategy.
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