GRI Bio, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsGRI Bio is a clinical-stage biopharmaceutical company developing GRI-0621, an oral type 1 iNKT cell inhibitor for fibrotic lung disease, with no product revenue today.
What they do
GRI Bio develops therapies targeting dysregulated immune responses in inflammatory, fibrotic and autoimmune disorders. Its lead candidate GRI-0621 is an oral formulation of tazarotene, a RAR-beta/gamma selective agonist, being developed for idiopathic pulmonary fibrosis (IPF). A second program, GRI-0803, is a type 2 dNKT agonist advancing toward IND-enabling activities.
Revenue drivers
- GRI-0621 (IPF) — Lead clinical-stage asset; no product revenue, value tied to Phase 2a results and potential regulatory pathways in the U.S. and Europe.
- GRI-0803 (autoimmune) — Earlier-stage dNKT agonist program moving toward IND-enabling activities; no revenue and no clinical data in the excerpts.
- Financing, not sales — Operations funded by equity; the ATM facility generated approximately $6.8 million in gross proceeds during Q1 2026.
Recent performance
Annual net losses were $12.0M in 2025 and $8.2M in 2024, with accumulated deficit of $51.7M as of December 31, 2025. Operating cash flow was -$10.2M in 2025 and -$8.6M in 2024. Cash was approximately $11.0M at March 31, 2026 versus $8.2M at December 31, 2025, and $10.9M at June 30, 2026. Q1 2026 R&D expense fell to approximately $0.4M from approximately $1.6M in Q1 2025 due to completion of the Phase 2a trial.
Strategy
Management is advancing GRI-0621 toward pivotal studies via clinical development planning for U.S. and European regulatory pathways. It is progressing GRI-0803 toward IND-enabling activities to broaden the pipeline into autoimmune indications. It has filed additional patent applications based partly on Phase 2a data. It funded operations partly through an ATM facility, raising approximately $6.8 million gross in Q1 2026.
Risks
- No revenue and continuing losses — GRI has incurred net losses since inception ($12.0M in 2025) with no product sales and expects several years before any revenue.
- Need for additional capital — Management states a Phase 2b trial of GRI-0621 without a partner would require substantial additional expense beyond current cash.
- Early-stage clinical risk — GRI-0621 has completed only a 35-patient Phase 2a trial in IPF, and exploratory endpoints including RNAseq, TCRseq and pharmacodynamics are still being analyzed.
- Nasdaq listing-rule history — An 8-K filed January 16, 2026 reported a delisting notice or listing-rule failure, and a January 21, 2026 filing covered modified rights of security holders and charter amendments.
Outlook
GRI Bio says existing cash is sufficient to fund planned operating expenses and capital expenditure requirements into the second quarter of 2027. Management is planning clinical development activities for GRI-0621 to support potential U.S. and European regulatory pathways and advancing GRI-0803 toward IND-enabling activities. The company expects it will be several years, if ever, before it generates revenue from product sales.