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8-K2026-05-14· qwen-plus

GRI · GRI Bio, Inc.

0001824293-26-000046

SEC filing

Summary

GRI Bio reported Q1 2026 net loss of $2.0 million, a $1.0 million improvement year-over-year, driven by reduced R&D expenses following completion of its Phase 2a trial; cash totaled $11.0 million as of March 31, 2026, supporting operations into Q2 2027, and Phase 2a data showed clinically meaningful improvements in cough, dyspnea, diarrhea, and FVC for GRI-0621 in IPF.

Key takeaways

Full analysis

GRI Bio’s Q1 2026 financial results reflect a deliberate de-escalation in R&D spending following the completion of its Phase 2a trial of GRI-0621 in IPF during 2025 — driving a $1.0 million reduction in net loss year-over-year to $2.0 million. R&D expenses fell sharply to $0.4 million (from $1.6 million in Q1 2025), while G&A rose modestly to $1.6 million (from $1.4 million), consistent with advancing regulatory planning and pipeline development. The company ended the quarter with $11.0 million in cash — a $2.8 million increase from December 31, 2025 — bolstered by $6.8 million in gross proceeds from its At-The-Market facility. Management explicitly states this cash position supports planned operations into the second quarter of 2027, contingent on only initial preparatory activities for GRI-0621; pivotal studies will require substantial additional capital. Critically, the press release (Exhibit 99.1) anchors investor attention on Phase 2a clinical outcomes: zero cough, no weight loss, and a 61% reduction in diarrhea versus placebo — even though 67% more patients in the active arm received nintedanib, a drug known for GI toxicity. This tolerability profile, combined with +99 mL FVC improvement and mechanistic evidence of immune rebalancing and epithelial repair, strengthens the therapeutic rationale for GRI-0621 in IPF and informs ongoing U.S. and EU regulatory pathway planning. Concurrent advancement of GRI-0803 into IND-enabling work signals disciplined pipeline expansion beyond fibrosis into high-unmet-need autoimmune indications.