GRI Bio Reports First Quarter 2024 Financial Results and Provides Corporate Update - Seite 2

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. 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 Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.

The Company plans to leverage the 505(b)(2) regulatory pathway and has launched a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624.

Expected GRI-0621 Upcoming Milestones

• Q3 2024: Report interim data from Phase 2a biomarker study
• Q4 2024: Report topline results from Phase 2a biomarker study

GRI-0803: Novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on SLE.

SLE is an autoimmune disease in which the immune system attacks its own tissue and organs. SLE is the most common form of lupus. Current treatments are limited, consisting primarily of immunosuppressive therapies.

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 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.

Expected GRI-0803 Upcoming Milestones

• Q3 2024: Complete IND-enabling studies
• Q3 2024: File IND and launch Phase 1a/b
• Q4 2024: Report Phase 1a single ascending dose (SAD) study topline results
• Q4 2024: Report Phase 1b multiple ascending dose (MAD) study topline results

Summary of Financial Results for First Quarter 2024

Net loss was $1.9 million for the three months ended March 31, 2024.

Research and development expenses were $0.9 million and $0.1 million for the three months ended March 31, 2024 and 2023, respectively.