GRI Bio Presents Positive Preclinical Data from Pipeline of NKT Cell Modulators in Development for the Treatment of Systemic Lupus Erythematosus (SLE)

Data presented at the 14^th International Congress on Autoimmunity

Encouraging preclinical data observed to date on par with OFEV (nintedanib),
a leading tyrosine kinase inhibitor with 2025 projected sales of $5 billion¹

Company targeting IND filing for GRI-0803 in Q3 2024 with topline data expected Q4 2024

LA JOLLA, CA, May 21, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio,” “we,” “our,” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced Vipin Kumar Chaturvedi, PhD, Chief Scientific Officer of GRI Bio presented encouraging preclinical data from the Company’s preclinical studies of type 2 NKT activating molecules, GRI-0803 and GRI-0124 at the 14^th International Congress on Autoimmunity held May 17-20, 2024 in Ljubljana, Slovenia (the Congress).

GRI Bio’s 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.

Dr. Chaturvedi commented, “There remains a significant unmet need for safe and effective treatment options for SLE as current treatments are limited, consisting primarily of immunosuppressive therapies. Based on the data demonstrated by GRI-0803 and GRI-0124 to date, we believe these innovative small molecules leveraging NKT science have the potential to target earlier in the inflammatory cascade to interrupt disease progression. We remain encouraged by GRI-0803’s potential and are working in earnest to validate bioanalytical methods, complete cGMP manufacturing, and complete toxicology studies in order to file our IND for GRI-0803 in the second half of 2024.”