GRI Bio Reports First Quarter 2024 Financial Results and Provides Corporate Update

Interim data readout of Phase 2a biomarker study evaluating lead program GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) expected Q3 2024 and topline data on track for Q4 2024

Ongoing progress of Investigational New Drug (IND) enabling studies in systemic lupus erythematosus (SLE) program for GRI-0803 with IND filing expected in H2 2024

LA JOLLA, CA, May 13, 2024 (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 first quarter ended March 31, 2024 and provided a corporate update.

"We continue to execute on both the clinical and corporate fronts. Our team is working diligently to drive our Phase 2a biomarker study in IPF toward interim data readout which we believe will provide valuable insight for our development program moving forward,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “On the corporate side, we continue to bolster our patent estate as well as actively engage with and present at scientific meetings which we believe underscore the potential of GRI-0621. We are committed to building a growing body of data and believe we are positioned to unlock significant value in 2024.”

Recent Highlights

• Announced oral presentation at the 14^th International Congress on Autoimmunity;
• Expanded intellectual property protection for proprietary NKT cell modulators with issuance of Korea patent;
• Announced abstract titled, “Altered NKT Cell Populations in the Airways of Patients with IPF,” has been accepted for poster presentation at the 2024 American Thoracic Society International Conference;
• Received notice of allowance for Canadian patent covering proprietary NKT cell modulators;
• Received authorization of the Company’s Clinical Trial Application (CTA) by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK; and
• Closed a public offering with participation from healthcare focused institutional investors for aggregate gross proceeds of $5.5 million.

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