GRI Bio (NASDAQ

GRI) Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Phase 2a biomarker study of GRI-0621 for Idiopathic Pulmonary Fibrosis (“IPF”) on track to start before year end 2023; Interim data expected H1 2024

Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival¹

GRI-0803 systemic lupus erythematosus (“SLE”) program advancing towards completion of IND-enabling studies with IND filing on track for H1 2024

Annual prevalence estimated to be ~161,000 people in the United States affected with definite SLE² and current treatment options are limited

LA JOLLA, CA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” 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 reported its financial results for the quarter ended September 30, 2023 and provided a corporate update.

“Over the course of this year, we have made fundamental progress on the development and regulatory fronts for our lead program GRI-0621 for IPF as well as GRI-083 for SLE. Importantly, we believe 2024 will be the year of data for GRI Bio,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We believe we are positioning ourselves for a transformational year and have the potential to unlock significant value for all stakeholders.”

Recent Highlights

• Presented data supporting innovative pipeline of NKT cell modulators for the treatment of high-value inflammatory, fibrotic and autoimmune diseases at the 7^th Annual Antifibrotic Drug Development Summit;
• Presented translational data demonstrating connection between NKT cells and the pathogenesis of IPF at the 2023 Pittsburgh-Ireland International Lung Conference;
• Entered into a collaboration with the UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration to advance its leading NKT regulation technology to treat inflammatory, fibrotic and autoimmune diseases.
• Published comprehensive invariant NKT (“iNKT”) cell review in Frontiers in Immunology demonstrating a key role of type 1 iNKT cells in modulating various fibrotic conditions;
• Participated in conferences and investor-focused events (to watch replays of recent events, click here); and
• Announced GRI Bio’s entrance into an asset purchase agreement with Aardvark Therapeutics, Inc. (“Aardvark”) pursuant to which Aardvark will acquire certain assets and intellectual property of the Company that pertain to its legacy asset, ADAIR (Abuse Deterrent Amphetamine Immediate Release).

GRI-0621: Type 1 invariant NKT (“iNKT”) antagonist in development for the treatment of idiopathic pulmonary fibrosis (IPF).