Core Insights - GRI Bio, Inc. reported no decline in lung function in patients treated with GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) during a 6-week interim analysis, indicating potential efficacy and safety of the treatment [1][2][3] - The Phase 2a study is fully enrolled, with topline data expected in Q3 2025, highlighting the company's commitment to advancing its innovative pipeline [1][5] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [6] - The lead program, GRI-0621, is an oral therapeutic aimed at treating IPF, a disease with significant unmet medical needs [6] Study Details - The Phase 2a study is a randomized, double-blind, placebo-controlled trial involving approximately 35 subjects with IPF, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [3][4] - The primary endpoint is the safety and tolerability of GRI-0621, while secondary endpoints include changes in serum biomarkers and pharmacokinetics [3][4] Interim Analysis Findings - The interim analysis showed no worsening of forced vital capacity (FVC) in GRI-0621 treated patients, along with positive changes in biomarkers suggesting an anti-fibrotic effect [2][3] - Independent Data Monitoring Committee (IDMC) found GRI-0621 to be safe and well-tolerated, recommending the continuation of the study [4][2] Future Expectations - Topline results from the Phase 2a biomarker study are anticipated in Q3 2025, with additional data on flow cytometry and gene expression expected in the coming months [5]

Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [3] - The company's lead program, GRI-0621, is an oral therapeutic aimed at inhibiting iNKT cell activity for the treatment of idiopathic pulmonary fibrosis, addressing a significant unmet medical need [3] - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [3] Upcoming Events - Marc Hertz, PhD, CEO of GRI Bio, will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 3:00 PM ET in New York, NY [1] - Management will be available for in-person one-on-one meetings with qualified investors registered for the conference [2] - A live webcast of the presentation will be available on the company's website, with a replay archived for 90 days post-event [2]

Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [3] - The company's lead program, GRI-0621, is an oral therapeutic aimed at inhibiting iNKT cell activity for the treatment of idiopathic pulmonary fibrosis, addressing a significant unmet medical need [3] - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus, supported by a library of over 500 proprietary compounds [3] Upcoming Presentation - GRI Bio will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech from August 19-21, 2025, with a specific presentation scheduled for August 20, 2025, at 2:20 PM ET [1] - The presentation will be led by Marc Hertz, PhD, who serves as the President, Chief Executive Officer, and Director of GRI Bio [1]

Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [3] - The company is in the clinical stage and aims to fundamentally change treatment approaches for these diseases [3] Recent Developments - GRI Bio participated in a Virtual Investor segment where CEO Marc Hertz discussed interim biomarker data from a Phase 2a study in Idiopathic Pulmonary Fibrosis (IPF) [2] - The interim data was collected over a 6-week period, indicating progress in the ongoing study [2] Product Pipeline - GRI Bio's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as an oral therapeutic for IPF, which has significant unmet medical needs [3] - The company is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists aimed at treating systemic lupus erythematosus [3] - GRI Bio possesses a library of over 500 proprietary compounds, which supports the expansion of its product pipeline [3]

Core Insights - GRI Bio, Inc. is advancing its Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), showing promising interim biomarker results that indicate a positive impact on fibrogenesis and fibrolysis [1][2][3] - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the study as there are no safety concerns observed in the interim data [1][4][6] - Topline data from the Phase 2a study is expected in Q3 2025, with additional pulmonary function test data anticipated in the coming weeks [7] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][8] - The lead program, GRI-0621, is designed to inhibit iNKT cell activity and is being developed as an oral therapeutic for IPF, addressing a significant unmet medical need [8] Study Details - The Phase 2a study is a randomized, double-blind, multi-center, placebo-controlled trial involving approximately 35 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 (4.5mg) or placebo [3][4] - The primary endpoint is the safety and tolerability of GRI-0621, while secondary endpoints include changes in serum biomarkers and pharmacokinetics [3][4] Interim Results - The 6-week interim analysis showed a favorable reduction in fibrogenesis biomarkers and an improved fibrolytic profile in GRI-0621 treated patients compared to the control group [2][3] - The results indicate increased basement membrane remodeling and potential initiation of a repair response in patients treated with GRI-0621 [2][3] Future Expectations - The company anticipates reporting topline data later this year, along with findings regarding pulmonary function and additional biomarker data [3][7]

Core Insights - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][3] - The company’s lead program, GRI-0621, is an oral therapeutic aimed at treating idiopathic pulmonary fibrosis, addressing a significant unmet medical need [3] - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus, supported by a library of over 500 proprietary compounds [3] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company aiming to change the treatment landscape for inflammatory, fibrotic, and autoimmune diseases [3] - The company’s therapies target NKT cells, which play a crucial role in the inflammatory response and disease progression [3] - The company’s focus on NKT cells positions it uniquely in the biopharmaceutical industry, linking innate and adaptive immune responses [3] Leadership Insights - Dr. Marc Hertz, the President and CEO, shared his dedication to the company and insights into its development programs during a recent investor conference [2]

Core Insights - GRI Bio, Inc. has completed patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) [1][2] - The company is on track to report 6-week interim biomarker results in July 2025, with topline data expected in Q3 2025 [1][6] - GRI-0621 is being developed as a novel oral therapeutic targeting Natural Killer T (NKT) cells, which play a critical role in inflammatory and fibrotic diseases [8] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through NKT cell modulation [8] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity aimed at addressing the unmet needs in IPF treatment [8] Study Design and Results - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 35 subjects, with a 2:1 randomization for GRI-0621 (4.5mg) versus placebo [3] - Primary endpoint focuses on safety and tolerability after 12 weeks, while secondary endpoints include changes in serum biomarkers and pharmacokinetics [3] - Interim safety results from the first 12 and 24 patients indicated that GRI-0621 is safe and well-tolerated, with no significant changes in lipid levels observed [4][5] Future Expectations - The company anticipates reporting 6-week interim biomarker data in July 2025, followed by topline results in Q3 2025 [6]

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the study for GRI-0621, indicating no safety concerns in the reviewed data [1][3] - Interim results show GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated, with no adverse events related to hyperlipidemia [3][4] - The company expects to report 6-week interim biomarker data in July 2025, with topline results anticipated in Q3 2025 [5] Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][7] - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [2][7] - The ongoing Phase 2a study is randomized, double-blind, and placebo-controlled, enrolling approximately 36 subjects with idiopathic pulmonary fibrosis (IPF) [4][5] Study Details - The Phase 2a study evaluates GRI-0621 at a dose of 4.5mg orally once daily for 12 weeks, with a primary endpoint focused on safety and tolerability [4][5] - Secondary endpoints include changes in serum biomarkers at weeks 6 and 12, pharmacokinetics assessment, and pharmacodynamic activity of GRI-0621 [4][5] - The study also includes a sub-study examining NKT cell activity in bronchoalveolar lavage fluid [4]

Core Insights - GRI Bio, Inc. presented positive preclinical data at the 2025 ATS International Conference, indicating that GRI-0621 has potential anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis [1][2][3] - The ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) is expected to provide interim analysis results in Q2 2025 [1][3] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][10] - The lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity and is currently in a 12-week, double-blind, randomized, placebo-controlled study for IPF [6][10] Clinical Study Details - The Phase 2a study aims to assess the safety and tolerability of GRI-0621, along with its effects on various biomarkers associated with disease progression [6][7] - Interim results from the first 12 patients indicated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels [7][9] Research Findings - The presented data included biochemical, qPCR, and immunohistochemistry analyses, demonstrating that iNKT cell inactivation during the fibrotic phase can significantly inhibit fibroblast activation and fibrosis in a murine model [4][8] - GRI-0621 showed therapeutic effects in reducing lung injury and impacting key cellular and molecular drivers of lung disease, performing comparably or better than the approved drug nintedanib [8][9] Future Expectations - The interim analysis committee has recommended the continuation of the Phase 2a study, with topline results expected in Q3 2025 [9]

Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [4] - The company's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as a novel oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [4] - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [4] Upcoming Event - Marc Hertz, PhD, CEO of GRI Bio, will participate in the Virtual Investor Closing Bell Series on May 28, 2025, at 4:00 PM ET, providing a corporate overview and business outlook [1][2] - The event will allow investors and interested parties to submit questions live, with the company aiming to answer as many as possible within the time allowed [2] Webcast Information - A live video webcast of the event will be available on the company's website, with a replay accessible for 90 days following the live event [3]