What GRI Bio does

GRI Bio, Inc. is a clinical-stage biopharmaceutical company headquartered in La Jolla, California and listed on NASDAQ under ticker GRI. Founded around 2015 and reorganized through a December 2022 reverse merger with Vallon Pharmaceuticals (backed by a $15 million Altium Capital investment), the company is developing an NKT cell modulator platform that targets Natural Killer T cells — innate-like lymphocytes bridging adaptive and innate immunity — to interrupt the inflammatory cascade upstream of existing therapies. The platform pairs an iNKT cell inhibitor strategy (lead asset GRI-0621, an oral RAR-β/γ selective agonist) with a dNKT cell activator strategy (GRI-0803 for systemic lupus erythematosus), backed by a library of over 500 proprietary compounds and patent coverage through 2036.

The lead clinical program, GRI-0621, is being advanced in idiopathic pulmonary fibrosis (IPF) and reported positive Phase 2a topline data in December 2025 — zero cough, 61% lower treatment-related diarrhea versus placebo, and a +99 mL FVC improvement at 12 weeks — and received FDA Orphan Drug Designation in June 2026. The pipeline also includes GRI-0803 in IND-enabling activities for SLE, plus disclosed interest in MASH/NASH and additional fibrotic indications. Composition-of-matter protection was expanded with US Patent No. 12,528,775 issued in January 2026 and a UAE patent allowance in April 2026.

GRI Bio currently generates no product revenue. Its go-to-market is structured around advancing GRI-0621 toward pivotal studies and FDA approval, with a stated intent to leverage commercialization partnerships for global distribution post-approval. Operations are funded through repeated public offerings (cumulative proceeds above $37 million since 2022) via H.C. Wainwright as exclusive placement agent, with approximately $11.0 million in cash at Q1 2026 supporting runway into Q2 2027 against a $12 million FY2025 net loss.

Name

GRI Bio

Legal name

GRI Bio, Inc.

Website

https://gribio.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

GRI Bio is a clinical-stage biopharmaceutical company developing NKT cell modulator therapies — oral small molecules targeting invariant and diverse Natural Killer T cells — for inflammatory, fibrotic, and autoimmune diseases, with its lead candidate GRI-0621 in Phase 2a development for idiopathic pulmonary fibrosis.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

Keywords

• NKT cell modulators
• Inflammatory disease therapeutics
• Fibrotic disease treatments
• Autoimmune disease therapies
• Biopharmaceutical drug development

Headquarters

HQ city

La Jolla

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Drug Development and Commercialization: GRI Bio is a clinical-stage biopharmaceutical company with no current product revenue. The company is developing therapies targeting NKT cells for inflammatory, fibrotic, and autoimmune diseases. GRI-0621 is in Phase 2a clinical trials for idiopathic pulmonary fibrosis (IPF), and GRI-0803 is in IND-enabling activities for systemic lupus erythematosus. Revenue will be generated from product sales upon regulatory approval and commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

GRI Bio is a clinical-stage biopharmaceutical company developing oral small-molecule NKT cell modulators for inflammatory, fibrotic, and autoimmune diseases. Its lead candidate GRI-0621 is in Phase 2a development for idiopathic pulmonary fibrosis (IPF), and GRI-0803 is advancing toward IND-enabling studies for systemic lupus erythematosus (SLE). Both candidates are drawn from a proprietary library of more than 500 NKT cell-modulating compounds.

Product overview

GRI Bio is a clinical-stage biopharmaceutical company advancing an innovative pipeline of NKT cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases. The company's portfolio consists of lead program GRI-0621 (an oral RAR-βɣ dual agonist for idiopathic pulmonary fibrosis), GRI-0803 (a dNKT cell agonist for autoimmune diseases including systemic lupus erythematosus), and a proprietary library of over 500 compounds that supports ongoing pipeline expansion. The therapies are designed to target NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore immune system homeostasis.

Differentiator

Problem solved

Functional benefit

Products and services

• GRI-0621

Quantifiable outcome

• Zero cough observed in GRI-0621 active arm vs 25% in placebo arm at 12 weeks
• +5 more outcomes

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Pliant Therapeutics: Clinical-stage biopharmaceutical company developing novel therapies for fibrotic diseases, including IPF. Directly comparable to GRI Bio as a small-cap IPF-focused biotech with Phase 2-stage assets targeting fibrosis.
• FibroGen: Biopharmaceutical company developing therapeutics for fibrotic diseases and cancer, with an IPF program (pamrevlumab). Comparable to GRI Bio in IPF indication focus and clinical-stage development approach.
• Blade Therapeutics: Clinical-stage biopharmaceutical company developing antifibrotic therapies, including lead asset cudetaxestat for IPF. Comparable to GRI Bio in target indication, stage of development, and small-cap biotech profile.
• Galapagos NV: European clinical-stage biotechnology company with an IPF program (GLPG1205/ziritaxestat). Comparable to GRI Bio as a small-cap biotech targeting IPF with novel mechanisms.

Broad incumbents

• United Therapeutics: Larger biopharmaceutical company with an approved IPF therapy (Tyvaso) and active pipeline in pulmonary hypertension and fibrotic lung disease. Relevant incumbent competitor in the IPF space.
• Boehringer Ingelheim: Global pharmaceutical company and maker of Ofev (nintedanib), the leading FDA-approved IPF therapy. Represents the dominant competitive incumbent that GRI-0621 would need to displace or complement.
• Roche / Genentech: Maker of Esbriet (pirfenidone), the other established FDA-approved IPF therapy. Major incumbent competitor with deep IPF commercial infrastructure and prescriber relationships.
• Bristol Myers Squibb: Major biopharmaceutical company with a broad autoimmune disease portfolio (including SLE therapies like Saphnelo). Relevant incumbent for GRI Bio's GRI-0803 dNKT program targeting systemic lupus erythematosus.
• AbbVie: Global biopharmaceutical leader with established autoimmune disease franchise including therapies for SLE. Comparable as a potential strategic competitor or acquirer for GRI Bio's autoimmune pipeline.

Emerging players

• Vicore Pharma: Swedish clinical-stage pharmaceutical company developing buloxibutid (C21) for IPF. Comparable to GRI Bio as an emerging player in IPF with a novel mechanism of action.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/GRI_BIO
• LinkedInlinkedin.com/company/glycoregimmune-inc.

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds6 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about GRI Bio