GRI Bio, Inc.

GRI Bio, Inc. held its 2026 Annual Meeting of Stockholders where shareholders approved an amendment to the Amended and Restated 2018 Equity Incentive Plan. This amendment increases the number of shares reserved for issuance by 546,529 and extends the evergreen provision to January 1, 2036. Additionally, W. Marc Hertz, Ph.D. and David Szekeres were elected as Class III directors, and WithumSmith+Brown, PC was ratified as the independent registered public accounting firm. A quorum of approximately 42.37% of eligible shares was present.

GRI Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy, GRI-0621, for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This designation is a significant regulatory milestone, potentially offering seven years of U.S. market exclusivity upon approval and providing other development benefits. The company highlighted that GRI-0621 has shown promise in a Phase 2a trial, meeting key endpoints and reinforcing its potential to address the unmet medical needs in IPF.

GRI Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy, GRI-0621, for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This designation is a significant regulatory milestone, potentially offering seven years of U.S. market exclusivity upon approval, tax credits, and waived FDA fees. GRI-0621, an oral RARβ/γ-selective agonist, previously met all primary, secondary, and exploratory endpoints in a Phase 2a trial involving 35 IPF patients. The company views this as validation of its development strategy and a step towards addressing significant unmet medical needs in fibrotic diseases.

GRI Bio, Inc. announced that its Chief Executive Officer, Marc Hertz, PhD, will participate in a fireside chat at A.G.P. ’s Annual Healthcare Company Showcase on Wednesday, May 20, 2026. During the virtual event, management will discuss the company ’s innovative pipeline of Natural Killer T (NKT) cell modulators and provide updates on its inflammatory, fibrotic, and autoimmune disease programs. A live webcast of the presentation will be available for investors on the company's website.

GRI Bio reported its first quarter 2026 financial results and provided a corporate update, highlighting positive Phase 2a data for GRI-0621 in Idiopathic Pulmonary Fibrosis (IPF). The data reinforced GRI-0621's differentiated therapeutic potential, showing improved tolerability with zero cough and significantly reduced treatment-related diarrhea, alongside improvements in lung function. The company also advanced GRI-0803 toward IND-enabling activities and strengthened its balance sheet, with approximately $11.0 million in cash and a runway into the second quarter of 2027.

GRI Bio announced positive Phase 2a clinical trial data for GRI-0621 in idiopathic pulmonary fibrosis (IPF), showing zero cough and 60% less treatment-related diarrhea compared to placebo, alongside improved lung function. The company reported a net loss of $2.0 million for Q1 2026, with cash and equivalents totaling $11.0 million as of March 31, 2026. These funds are expected to support operations into Q2 2027, as GRI Bio advances GRI-0621 towards pivotal studies and GRI-0803 towards IND-enabling activities.

GRI Bio, Inc. reported a reduced net loss of $2.0 million for Q1 2026, down from $3.0 million in Q1 2025, primarily due to a significant decrease in research and development expenses. The company's cash and cash equivalents increased to $11.0 million as of March 31, 2026, bolstered by $6.8 million in gross proceeds from its At The Market (ATM) offering. Additionally, the Phase 2a clinical trial for its lead product candidate, GRI-0621, for idiopathic pulmonary fibrosis (IPF) met its primary and secondary endpoints, showing positive safety and anti-fibrotic effects. Despite improved liquidity, the company noted substantial doubt about its ability to continue as a going concern without further capital.