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]

Data presented at the 2025 American Thoracic Society (ATS) International Conference Pre-clinical and interim clinical results underscore GRI-0621’s potential to have both anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis Results from 6-week interim analysis (n=24) in ongoing Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) anticipated in Q2 2025 LA JOLLA, CA, May 22, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotec ...

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]

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] Event Participation - Marc Hertz, PhD, CEO of GRI Bio, will participate in a fireside chat at A.G.P.'s Annual Healthcare Company Showcase on May 21, 2025, at 2:40 PM ET [1] - The event will be accessible via a live webcast on the company's website [2]

Core Insights - GRI Bio, Inc. reported positive interim results from its ongoing Phase 2a study of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), indicating safety and potential anti-fibrotic effects [1][2][8] - The company has completed patient enrollment for the 6-week interim analysis with 24 patients and has over two-thirds of enrollment completed for the overall trial [1][8] - GRI Bio's cash runway is expected to fund operations through Q3 2025, bolstered by a recent public offering that raised $5 million [11] Clinical Program Update - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [5][12] - The interim analysis demonstrated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels among the first 12 patients evaluated [6][7] - The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2a study based on the observed safety and biomarker data [7][8] Financial Results - For Q1 2025, GRI Bio reported a net loss of $3 million, with research and development expenses of $1.6 million and general and administrative expenses of $1.4 million [10] - As of March 31, 2025, the company had approximately $3.3 million in cash and cash equivalents, which, along with the recent public offering, is expected to support operations through Q3 2025 [11] Upcoming Milestones - Topline results from the Phase 2a biomarker study are anticipated in Q3 2025, with a 6-week interim results report expected in Q2 2025 [9][14]

The Independent Data Monitoring Committee (IDMC) has recommended to continue the study as planned as there are no safety concerns seen in the data reviewed Continued momentum with completed patient enrollment for the 6-week interim analysis (N=24) and over two-thirds enrollment completed for the overall trial Results on track for interim data in Q2 2025 and topline data in Q3 2025 Management releases “What This Means” segment discussing the interim biomarker data; Access Here LA JOLLA, CA, May 08, 2025 (GLO ...

Core Insights - GRI Bio, Inc. has completed enrollment for a Phase 2a study evaluating GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), with 24 out of 36 planned patients enrolled [1][2] - The company is on track to report interim biomarker data from the first 12 patients imminently, with topline results expected in Q3 2025 [1][4] - The Phase 2a study is designed as a randomized, double-blind, placebo-controlled trial, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [2][3] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through Natural Killer T (NKT) cell modulators [5][6] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity, aimed at addressing the significant unmet need in IPF treatment [6] Study Details - The study will enroll approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 or placebo [2] - Primary endpoints include safety and tolerability, while secondary endpoints focus on changes in serum biomarkers and pharmacokinetics [2][3] - An interim analysis will be conducted after 24 subjects complete 6 weeks of treatment, with safety results from the first 12 patients showing no significant adverse effects [3]

Core Insights - GRI Bio, Inc. is advancing a pipeline of Natural Killer T (NKT) cell modulators aimed at treating inflammatory, fibrotic, and autoimmune diseases [1][3] - The company will present its research on the inactivation of iNKT cells and its effects on fibroblast activation and fibrosis at the 2025 ATS International Conference [2] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on innovative treatments for inflammatory, fibrotic, and autoimmune diseases [3] - The company's lead program, GRI-0621, is an inhibitor of iNKT cell activity, targeting idiopathic pulmonary fibrosis, a disease with significant unmet medical needs [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 pipeline [3]

LA JOLLA, CA, April 02, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the closing of its previously announced public offering of an aggregate of 1,388,888 shares of its common stock (or common stock equivalents in lieu thereof), Series E-1 warrants to purchase up to 1,388,888 shares of co ...