tazarotene oral (GRI-0621) / GRI Bio - LARVOL DELTA

GRI-0621 phase 2a biomarker study in patients with IPF: a safety signal demonstrating favorable tolerability. (ERS 2026) - "80% of the subjects enrolled were taking either pirfenidone (n=7) or nintedanib (n=21). Unlike many pan-retinoid receptor agonists, treatment with GRI-0621, a selective RARβ/γ dual agonist, did not result in dyslipidemia, night vision abnormalities or psychological changes during the 12-weeks of treatment. This safety profile further strengthens the potential clinical utility of GRI-0621 and assists in establishing GRI-0621 as a well-tolerated RARβ/γ dual agonist."

Biomarker • Clinical • P2a data • Cough • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Idiopathic Pulmonary Fibrosis • Immunology • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics

Late Breaking Abstract - Safety, translational biomarkers and lung function with the oral RARβ/γ-selective agonist GRI-0621 in idiopathic pulmonary fibrosis: a Phase 2a randomised, double-blind, placebo-controlled trial (GRI-0621-IPF-02) (ERS 2026) - P2 | "35 patients with IPF were randomised 2:1 to oral GRI-0621 4.5 mg once daily (n=23) or placebo (n=12) for 12 weeks; 80% received background pirfenidone or nintedanib. Selective RARβ/γ agonism produced convergent molecular, biomarker, immune and functional signals of attenuated fibrotic remodelling and epithelial/basement-membrane repair, with early FVC stabilisation, supporting larger adequately powered trials."

Biomarker • Clinical • Late-breaking abstract • P2a data • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Musculoskeletal Diseases • Pulmonary Disease • Respiratory Diseases

GRI-0621 phase 2a biomarker study in patients with IPF: GRI-0621 has a positive effect on FVC after 12 weeks of treatment (ERS 2026) - "Importantly, subjects who experienced a a 10% or greater decline in FVC from baseline over the study period showed a 60% reduction in the GRI-0621-treated arm compared with the placebo arm (8% vs 20%, respectively). These data further strengthen the potential clinical proof of concept and reinforce the therapeutic differentiation of GRI-0621."

Biomarker • Clinical • P2a data • Idiopathic Pulmonary Fibrosis

GRI-0621 Phase 2a biomarker study in patients with IPF using gene expression, immune cell activity and collagen markers supports a repair phenotype with strong anti-fibrotic and pro-resolving effects (ERS 2026) - "Flow cytometry analysis of PBMC and BAL fluid samples further supported findings observed with RNA sequencing and serum biomarkers and indicated reduced pro-inflammatory and increased anti-fibrotic immune cell phenotypes in GRI-0621-treated subjects compared to placebo-treated subjects. Taken together, RNA sequencing, serum biomarkers, and flow cytometry trends were consistently supportive of the hypothesis that GRI-0621 treatment reduces lung injury, myofibroblast activation, and ECM deposition, and induces a lung repair mechanism."

Biomarker • Clinical • Immune cell • P2a data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology

GRI-0621 Improves FVC, Reduces Fibrotic Biomarkers in IPF (HCPLive) - "Placebo-adjusted FVC change was +99 mL overall and +139 mL among patients also receiving background antifibrotic therapy. The proportion of patients with no FVC decline rose to 39% with GRI-0621 versus 20% with placebo, while the proportion with a decline of 10% or more fell to 8% versus 20% with placebo....Biomarker analyses showed GRI-0621 reduced type III and VI collagen formation while increasing collagen degradation, increased type IV collagen formation, and lowered neutrophil, macrophage, and pro-fibrotic T-helper 2 (Th2) cell activity relative to placebo."

Biomarker • P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio to Present Late-Breaking Phase 2a GRI-0621 Data Highlighting Lung Function, Anti-Fibrotic Biomarkers and Favorable Tolerability in IPF at ERS 2026 (GlobeNewswire) - "The presentations will include a late-breaking oral presentation as well as three posters evaluating the safety and tolerability, translational biomarker profile and potential impact on lung function of GRI-0621, the Company’s oral retinoic acid receptor ('RAR') β/γ-selective agonist being developed for the treatment of idiopathic pulmonary fibrosis ('IPF')."

P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "GRI-0621...was evaluated in a randomized, double-blind, placebo-controlled Phase 2a trial (GRI-0621-IPF-02; NCT06331624) in 35 patients with IPF, approximately 80% of whom were on background standard-of-care (SOC) antifibrotics. The trial met its primary, secondary and exploratory endpoints, with continued analyses and positive outcomes supporting previously reported findings."

Orphan drug • Idiopathic Pulmonary Fibrosis

First Quarter 2026 Pipeline and Corporate Highlights (GlobeNewswire) - "Advanced clinical development planning activities for GRI-0621 to support potential regulatory pathways in both the United States and Europe; Progressed GRI-0803, the Company’s type 2 diverse Natural Killer T (dNKT) agonist program for autoimmune diseases, toward IND-enabling activities."

Clinical • Preclinical • Idiopathic Pulmonary Fibrosis • Immunology • Systemic Lupus Erythematosus

GRI Bio Announces Additional Positive Data from Phase 2a Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-of-Concept for GRI-0621 (GlobeNewswire) - "The Phase 2a, randomized, double-blind, multinational, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled 35 subjects with IPF who were randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo....Chronically activated iNKT cells downregulate the expression of their T cell receptor (TCR). GRI-0621-treated subjects demonstrated increased TCR expression after 12 weeks of treatment compared with baseline or placebo-treated subjects receiving standard of care. T cell subsets demonstrated increased type I-associated cytokines (IFN-γ) and reduced type 2 (IL-4 and IL-13) and type 3-associated cytokines (IL-17A and IL-22) in both BAL and PBMC samples."

P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio…announced positive topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ('IPF') (GlobeNewswire) - "The study met its primary endpoint and secondary endpoints demonstrating that GRI-0621 was well tolerated over a 12-week treatment period....PRO-C6, a biomarker of type VI collagen synthesis, was observed to decrease from baseline (-3%) in GRI-0621 treated subjects and increase (+12%) in subjects treated with placebo and standard of care. C6M, a biomarker of type VI collagen degradation, was observed to increase from baseline (+6%) in GRI-0621 treated subjects and decrease (-3%) in subjects treated with placebo and standard of care....Placebo-adjusted changes from baseline in FVC increased by 99 ml in the GRI-0621-treated arm and a 139 ml increase in the subset taking both GRI-0621 and standard of care compared to placebo plus standard of care."

Biomarker • P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio Inc - Receives Topline Data From Phase 2A Trial For Idiopathic Pulmonary Fibrosis - SEC Filing (TradingView) - "GRI BIO INC - trial meets primary endpoint & certain secondary endpoints; GRI-0621 well tolerated; no safety or tolerability concerns in GRI-0621 treated subjects."

P2a data • Idiopathic Pulmonary Fibrosis

GRI-0621-IPF-02: Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF (clinicaltrials.gov) - P2 | N=35 | Completed | Sponsor: GRI Bio Operations, Inc. | Active, not recruiting ➔ Completed

Biomarker • Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

GRI-0621-IPF-02: Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: GRI Bio Operations, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Biomarker • Enrollment closed • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

GRI Bio Reports 6-Week Interim Biomarker Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”) (GlobeNewswire) - P2a | N=36 | NCT06331624 | Sponsor: GRI Bio Operations, Inc. | "In the second interim analysis, biomarkers of fibrogenesis and fibrolysis, or the formation and degradation of collagen and extracellular matrix (ECM) turnover in fibrosis, were assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated a favorable reduction in fibrogenesis biomarkers (PRO-C3 and PRO-C6) and a net fibrolytic profile shown as the ratio of collagen formation to collagen degradation (e.g., PRO-C3/CTX-III, PRO-C4/C4Ma3 and PRO-C6/C6M ratios)....Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date....Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025."

Biomarker • DSMB • P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio Completes Enrollment in Phase 2a Study of GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis (“IPF”) (GlobeNewswire) - "GRI Bio...announced the completion of patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ('IPF')....The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled approximately 35 subjects with IPF who were randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo....The Company expects to report 6-week interim biomarker data in July 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025."

Biomarker • Enrollment closed • P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio’s GRI-0621 Demonstrates Encouraging Safety Results at Planned Interim 6-Week Analysis in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”) (GlobeNewswire) - P2a | N=36 | NCT06331624 | Sponsor: GRI Bio Operations, Inc. | "The pre-planned interim analysis for 6-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 24 patients evaluated per protocol. There were no adverse events associated with hyperlipidemia, as assessed by LDL, HDL and triglyceride ('TG') levels in the 24 patients assessed at the 6-week visit. There were no clinically meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, consistent with the safety data reported after the first 12 subjects completed 2-weeks of treatment, and all subjects remained within protocol accepted ranges....The Company expects to report 6-week interim biomarker data in July 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025."

Biomarker • P2a data • Idiopathic Pulmonary Fibrosis

Inactivation of iNKT Cells After the Inflammatory Phase Leads to Significant Inhibition of Fibroblast Activation and Fibrosis in a Model of Pulmonary Fibrosis (ATS 2025) - "Inhibition of iNKT cells prophylactically with GRI-0621 significantly inhibited both inflammation and fibrosis in bleomycin-induced lung injury (Calamita et.al., AJRCCM, 2024:210(4), 521-523). Collectively, our data indicate that oral administration of GRI-0621 has both anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis. These data contribute to our understanding of the role of iNKT cell activity in driving pulmonary fibrosis and underpin the ongoing Phase 2a study examining the safety and tolerability of GRI-0621 and its effect on various biomarkers in IPF patients."

IO biomarker • Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IFNG • IL13 • IL17A • IL4 • TGFB1

GRI Bio…Reiterates Promising Preliminary Phase 2a Clinical Results (GlobeNewswire) - P2a | N=36 | NCT06331624 | Sponsor: GRI Bio Operations, Inc. | "Additionally, interim biomarker results from the first 12 subjects at 2 weeks were reviewed by the IDMC and determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients is suggestive of anti-fibrotic effect. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date....Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025."

DSMB • P2a data • Trial status • Idiopathic Pulmonary Fibrosis

GRI Bio Presents Positive Pre-Clinical Data Demonstrating GRI-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced Fibrosis (GlobeNewswire) - "In a therapeutic regimen of the bleomycin-induced fibrosis model, orally administered GRI-0621 after completion of the inflammatory phase (Day 7), significantly inhibits lung injury and several important fibrotic cellular and molecular drivers of lung disease, including fibroblast activation and fibrosis; GRI-0621 demonstrated to impact key innate and adaptive cell activity, cytokine production, myofibroblast activation, and ECM deposition and fibrosis; GRI-0621 inhibition of iNKT cell activity is therapeutic in treatment models of pulmonary fibrosis and performs as well or better than the approved drug nintedanib."

Preclinical • Fibrosis • Pulmonary Disease

GRI Bio's Interim Biomarker Data Demonstrate Positive Trend Towards Anti-Fibrotic Effect of GRI-0621 in First Twelve Patients of Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”) (GlobeNewswire) - P2a | N=36 | NCT06331624 | Sponsor: GRI Bio Operations, Inc. | "GRI Bio, Inc...reported interim biomarker results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ('IPF')....As previously announced, the pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol....There were no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, and all subjects remained within normal ranges. The interim analysis committee recommended the study should continue as planned....Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025."

P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio Continues to Drive Enrollment in Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”) (GlobeNewswire) - "Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled....GRI Bio, Inc....today announced that enrollment for the 6 week interim analysis is complete with 24 of the 36 planned patients randomized in its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ('IPF')....Our team is working to bring enrollment to its completion, expected this quarter..."

Enrollment status • Idiopathic Pulmonary Fibrosis

GRI Bio Announces Abstract Selected for Poster Discussion Session at the 2025 American Thoracic Society (ATS) International Conference (GlobeNewswire) - "GRI Bio, Inc...today announced that its abstract has been selected for poster presentation in a poster discussion session at the 2025 ATS International Conference being held May 18-21, 2025 in San Francisco, CA."

Preclinical • Fibrosis

GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”) (GlobeNewswire) - P2a | N=36 | NCT06331624 | Sponsor: GRI Bio Operations, Inc. | "The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed....The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol....An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment. The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment....The Company expects to report interim biomarker data in Q2 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025."

DSMB • P2a data • Idiopathic Pulmonary Fibrosis

GRI Bio Reports Full Year 2024 Financial Results and Reiterates Expected Clinical Data Readouts in 2025 for Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis ('IPF') (GlobeNewswire) - "The Company plans to leverage the 505(b)(2) regulatory pathway for this candidate....Expected GRI-0621 Upcoming Milestones: Q2 2025: Report interim data from Phase 2a biomarker study. Q3 2025: Report topline results from Phase 2a biomarker study....Research and development expenses were $3.8 million and $3.2 million for the years ended December 31, 2024 and 2023, respectively. The $0.6 million increase in research and development expenses was primarily due to increased expenses related to the registrational development program of GRI-0621."

Biomarker • Commercial • P2a data • Idiopathic Pulmonary Fibrosis

GRI-0621-IPF-02: Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients with IPF (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: GRI Bio Operations, Inc. | Trial completion date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: Jan 2025 ➔ Jun 2025

Biomarker • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases