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

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

GRI Bio Showcases GRI-0621’s Potential to Reduce Inflammation, Type 1 Cytokines and Reduce Hepatic Fibrosis in Idiopathic Pulmonary Fibrosis (IPF) (GlobeNewswire) - "GRI Bio, Inc...announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF)....There was an increase in IFN-γ producing CD45+CD3+CD56+ NKT cells in IPF patients compared to controls. In a second cohort, we confirmed the iNKT phenotype using an anti-Vα24-Jα18 TCR antibody. In the bleomycin model, GRI-0621 inhibition of iNKT cells improved a majority of inflammatory, fibrotic, and pathological features, including a reduction in lung injury, myofibroblast activity, collagen deposition, and fibrosis....Interim data from the Phase 2a biomarker study is expected in the first quarter of 2025 and topline results are expected in the second quarter of 2025."

P2a data • Preclinical • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Reports Third Quarter 2024 Financial Results and Outlines Progress Towards Clinical Data Readout of GRI-0621 in Ongoing Phase 2a Study for Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Expected GRI-0621 Upcoming Milestones: Q1 2025: Report interim data from Phase 2a biomarker study; Q2 2025: Report topline results from Phase 2a biomarker study."

P2a data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Raises a Total of $13.9 Million in Gross Proceeds Since the Beginning of 2024 (GlobeNewswire) - "GRI Bio, Inc...announced that on October 22, 2024 it closed its previously announced transaction involving the exercise of certain existing warrants to purchase an aggregate of 762,236 shares of the Company’s common stock originally issued by GRI Bio in February 2024....'With these proceeds in hand and the continued progress toward interim and topline data for our lead program, expected in the coming quarters, we believe we are well positioned to realize the full potential of GRI-0621 to provide significant benefit to IPF patients.'"

Financing • P2a data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Presents Positive Preclinical Data Demonstrating GRI-0621’s Ability to Inhibit Invariant Natural Killer T (iNKT) Cell Activity and Reduce Important Inflammatory and Fibrotic Drivers in Idiopathic Pulmonary Fibrosis (IPF) (GlobeNewswire) - "GRI Bio, Inc...announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF)....Interim data from the Phase 2a biomarker study is expected in the fourth quarter of 2024 and topline results are expected in the first quarter of 2025."

P2a data • Preclinical • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Receives Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in Australia (GlobeNewswire) - "GRI Bio, Inc...today announced the authorization of its Clinical Trial Application (CTA) by the Australian Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Research Ethics Committee (HREC) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in Australia."

New P2a trial • Idiopathic Pulmonary Fibrosis

Type 1 invariant natural killer T cells drive lung fibrosis (ERS 2024) - "Wild-type (WT) C57BL/6 mice were instilled with a single dose of bleomycin (1.5 IU/Kg via the intratracheal route), with or without daily administration of GRI-0621, a small molecule selective inhibitor of iNKT activity, nintedanib, or control, via oral gavage. Compared to controls, GRI-0621 treated mice had improved fibrosis, pathology and reduced lung TGF-b. Collectively, these data suggest that NKT cells are activated in airways in IPF patients and inhibition of iNKT cell activity can ameliorate bleomycin-induced pulmonary fibrosis."

IO biomarker • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CXCR3 • CXCR5 • CXCR6 • IFNG • NCAM1 • NKG2D • PTPRC • SPP1

GRI Bio Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "GRI-0621 interim data readout of Phase 2a biomarker study on track for Q4 2024 and topline data on track for Q1 2025...The Company is currently focusing its available resources on GRI-0621, but, pending additional funding, the GRI-0803 IND-enabling and Phase1 program will continue in 2025."

Commercial • P2a data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Systemic Lupus Erythematosus

GRI Bio (NASDAQ: GRI) Participates in Virtual Investor “What This Means” Segment (GlobeNewswire) - "GRI Bio, Inc...announced the release of a Virtual Investor 'What This Means' segment. As part of this 'What This Means' segment, Marc Hertz, PhD, Chief Executive Officer of GRI Bio discusses the interim data and what this means for its ongoing IPF program, GRI-0621."

P2a data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Announces Publication of Positive Preclinical Data from Lead Program GRI-0621 in the American Journal of Respiratory and Critical Care Medicine (GlobeNewswire) - "GRI Bio, Inc...announced the publication of positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF)....Compared to controls, mice treated with GRI-0621 showed reduced fibrosis and immunopathology. Inhibition of iNKT activity led to a decrease in fibrosis score and total lung inflammation....Interim data from the Phase 2a biomarker study is expected in the third quarter of 2024 and topline results are expected in the fourth quarter of 2024."

P2a data • Preclinical • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Announces Korea Patent Granted for Proprietary Natural Killer T (NKT) Cell Modulators (GlobeNewswire) - "GRI Bio...today announced that the Korean Intellectual Property Office (KIPO) has granted Patent No. 10-2665487...The granted patent covers claims including compositions and methods for modulating type 2 and/or type 1 invariant NKT (iNKT) cells in the prevention and treatment of inflammatory conditions. More specifically, the patent covers the prevention and treatment of inflammatory, fibrotic and autoimmune conditions through the administration of a Retinoic Acid Receptor (RAR) agonist that inhibits iNKT cells in a subject...GRI Bio is currently advancing its lead program GRI-0621, a small molecule RAR-βɣ dual agonist candidate that inhibits the activity of human iNKT cells, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of Idiopathic Pulmonary Fibrosis (IPF)....Topline results from this study are expected in the fourth quarter of 2024."

P2a data • Patent • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Presents Positive Preclinical Data Demonstrating Lead Program GRI-0621 Reduces the Important Inflammatory and Fibrotic Drivers in Idiopathic Pulmonary Fibrosis (IPF) (GlobeNewswire) - "Company advancing Phase 2a biomarker study of GRI-0621 in patients with IPF with interim data expected Q3 2024 and topline data in Q4 2024...GRI Bio, Inc...presented positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF)....In an animal model of IPF, GRI-0621 was shown to reduce the fibrotic score, inhibit the production of TGFβ and VCAM-1 and reduce the immune cell."

P2a data • Preclinical • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Expected GRI-0621 Upcoming Milestones: Q3 2024: Report interim data from Phase 2a biomarker study; Q4 2024: Report topline results from Phase 2a biomarker study."

P2a data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Announces Abstract Accepted for Poster Presentation at the 2024 American Thoracic Society International Conference (GlobeNewswire) - "GRI Bio, Inc...announced that its abstract has been accepted for poster presentation at the 2024 ATS International Conference being held May 17-22, 2024 in San Diego, CA."

Clinical data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

GRI Bio Reports Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Ongoing Phase 2a biomarker study evaluating lead program GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) with interim data expected H1 2024 and topline data expected H2 2024...Research and development expenses were $3.2 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively. The $3.0 million increase in research and development expenses was primarily due to increases of $1.9 million in expenses related to the development program of GRI-0621, $0.4 million in personnel expenses, $0.6 million in consulting fees, and $0.1 million in intellectual property expenses."

Commercial • P2a data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

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.

Biomarker • New P2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases