Building the necessary clinical and operational infrastructure to support the upcoming Phase 2/3 adaptive design clinical study for Gemini in Acute Kidney Injury (AKI). This includes establishing a top-tier scientific advisory board, engaging a specialized clinical research organization (CRO) for renal studies, and completing nonclinical studies required for late-stage trials and NDA submission.

Expected impact: Enables rapid transition from Phase 2 to Phase 3 clinical testing under a single FDA-agreed adaptive trial design, significantly reducing development timelines and costs.

Initiation of Good Manufacturing Practice (GMP) manufacturing of Gemini active drug and placebo in collaboration with a leading global contract manufacturing organization (CMO).

Expected impact: Provides the necessary clinical drug supply for randomized, double-blind, placebo-controlled late-stage clinical studies.