---
schema_version: "secwatch.filing_event.v1"
accession: "0001824293-26-000002"
form_type: "8-K"
ticker: "GRI"
cik: "0001824293"
company_name: "GRI Bio, Inc."
filed_at: "2026-01-08T23:59:59+00:00"
generated_at: "2026-05-16T11:14:56.172226+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# GRI Bio reports positive Phase 2a immune data for GRI-0621 in IPF

## Summary
- Phase 2a data shows GRI-0621 reduces pro-fibrotic cytokines (IL-4, IL-13, IL-17A, IL-22, TGF-β) and increases anti-fibrotic IFN-γ in BAL and PBMC after 12 weeks.
- Study met primary safety/tolerability endpoint; secondary endpoints suggest fibrosis reversal and lung repair, with twice as many subjects with no FVC decline vs standard of care.
- 35 subjects enrolled, 2:1 randomized to GRI-0621 4.5mg or placebo for 12 weeks; sub-study in 8 subjects examines immune cells in BAL fluid.
- Company believes stockholders' equity exceeds $2.5M Nasdaq minimum after December 2025 public offering.

## SEC filing metadata
- accession: 0001824293-26-000002
- form_type: 8-K
- ticker: GRI
- cik: 0001824293
- company_name: GRI Bio, Inc.
- filed_at: 2026-01-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1824293/000182429326000002/0001824293-26-000002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1824293/000182429326000002/val-20260108.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001824293-26-000002
- JSON: https://secwatch.observer/filing/0001824293-26-000002.json
- Plain text: https://secwatch.observer/filing/0001824293-26-000002.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.
