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GRI Bio Reports First Quarter 2026 Financial Results, New Data Reinforcing Differentiated Profile of GRI-0621 in Idiopathic Pulmonary Fibrosis and Highlights Continued Advancement of Differentiated Immune-Modulating Pipeline

GRI
  • GRI Bio reported Phase 2a data for GRI-0621 in idiopathic pulmonary fibrosis (IPF) showing zero cough in the active arm versus 25% in the placebo arm, despite 67% higher nintedanib use in the active group.
  • The trial demonstrated a 61% reduction in treatment-related diarrhea (13% vs 33%) and a 76% reduction in dyspnea in patients receiving GRI-0621 plus standard of care compared to placebo plus standard of care.
  • No weight loss was observed in the active arm versus 17% in the placebo arm, and no serious adverse events were reported in the active arm compared to one in the placebo arm.
  • Exploratory pulmonary function data indicated a +99 mL improvement in FVC overall and +139 mL in the standard of care combination subset versus placebo at 12 weeks.
  • Biomarker analyses suggested disease-modifying benefits including immune rebalancing, active fibrolysis, basement membrane repair, and epithelial regeneration.
  • GRI Bio advanced GRI-0803, a type 2 diverse Natural Killer T cell agonist, toward IND-enabling activities to expand its autoimmune disease pipeline.
  • The company strengthened its balance sheet by generating approximately $6.8 million in gross proceeds from its At The Market facility during the first quarter of 2026.
  • Cash and cash equivalents totaled approximately $11.0 million as of March 31, 2026, with existing resources projected to fund operations into the second quarter of 2027.
  • Research and development expenses were approximately $0.4 million for the quarter ended March 31, 2026, down from $1.6 million in the same period in 2025 due to the completion of the Phase 2a trial.
  • General and administrative expenses were approximately $1.6 million for the quarter, compared to $1.4 million in the prior year period.
  • The company reported a net loss of approximately $2.0 million for the quarter ended March 31, 2026, compared to $3.0 million for the same period in 2025.
  • Additional patent applications were filed based on the Phase 2a clinical data, and advanced clinical development planning is underway for potential regulatory pathways in the US and Europe.