AyuVis is pioneering novel small molecule immunotherapies to prevent/treat inflammatory and infectious diseases based on a platform technology of macrophage modulation for a balanced immune response. An IND has been approved by the FDA in Jan 2024 for the lead candidate, AVR-48, to initiate a Phase 1 HAV clinical trial. AVR-48 has been granted Orphan Drug and Rare Pediatric Disease Designations for the prevention of bronchopulmonary dysplasia in preterm infants. We are first targeting a rare disease for high impact and a faster path to commercialization. The Phase 1 will also apply to follow-on respiratory conditions with unmet need, including ARDS and ventilator-associated pneumonia. Validated in extensive preclinical research, these immunotherapies are proven safe, to prevent organ damage, promote new cell growth, reduce mortality, and eliminate MDR bacteria via phagocytosis. Other therapeutic areas that can be addressed include ocular, renal, skin, and complicated infections/sepsis.