GRI Bio, Inc. second asset in development, GRI-0803, is a novel activator of human type 2 NKT cells. Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of type 1 invariant NKT (iNKT) cells. In the Company?s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells.

Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival. The Company is currently advancing development of GRI-0803 for the treatment of systemic lupus erythematosus disease (SLE), an autoimmune disease in which the immune system attacks its own tissue and organs. Key Highlights Observed from GRI Preclinical Studies: Data demonstrate iNKT cells accumulate in SLE patients and in NZBWF1 mice, have an activated phenotype and their hyporesponsiveness to in vitro stimulation suggests chronic activation: Type 2 NKT cells accumulate in NZBWF1 kidney, and remain responsive to in vitro restimulation: Type 2 NKT cell activation in NZBWF1 mice inhibits iNKT cell activity Once-weekly GRI-0124: Inhibited pro-inflammatory cytokines and signaling pathways in NZBWF1 mice, Decreased pDC accumulation and MHC class II expression, Inhibited CD4+, CD8+ T cells, and B cells (T1B and T2B cells), Reduced renal cellular infiltration and fibrosis, Inhibited proteinuria, anti-dsDNA Ig, and improved overall survival and proteinuria-free survival, GRI-0803 has demonstrated: Chemistry backbone based on type 2 GRI-0124 <400g/mol, Favorable solubility profile, Excellent bioavailability, PK profile supporting q.d. administration orally, No CV toxicology issues observed, no genotox and no activation or inhibition within CYP450 pathway.

No toxicology concerns to date.