SIRM-PREVENT 3.1 Investigational Program

1. Executive Summary The SIRM-PREVENT 3.1 system, directed by Ricky L. Cannon, is a first-in-class multi-pathway therapeutic designed to stabilize the "Biological Interlock" in Sickle Cell Disease patients. This brief summarizes the nonclinical safety data and clinical strategy for the Phase I First-in-Human study. +3 Nonclinical Safety Profile: Nonclinical evaluations in rat and dog models have established a robust safety margin for the 3.1 formulation.NOAEL (No Observed Adverse Effect Level): Data show a safety buffer of X5\timesX human exposure in rats and 3\timesX human exposure in dogs.Genotoxicity: The formulation demonstrated no genotoxic potential across standard assays.Organ Toxicity: No unexpected organ toxicity was observed during repeated-dose studies.