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]

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the Phase 2a study for GRI-0621, indicating no safety concerns in the reviewed data [1][2][4] - GRI Bio has completed patient enrollment for the 6-week interim analysis with 24 subjects and has over two-thirds of the total enrollment completed for the overall trial [1][3] - Interim biomarker results suggest an anti-fibrotic effect of GRI-0621 compared to placebo, with topline data expected in Q3 2025 [2][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][6] - The lead program, GRI-0621, is an oral therapeutic aimed at treating idiopathic pulmonary fibrosis (IPF), a disease with significant unmet medical needs [6] Study Details - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 (4.5mg) or placebo [3] - The primary endpoint is the safety and tolerability of GRI-0621 after 12 weeks, with secondary endpoints including changes in serum biomarkers and pharmacokinetics [3][4] Interim Analysis Findings - The interim analysis showed that GRI-0621 was safe and well-tolerated in the first 12 patients, with no significant changes in lipid levels [4] - The IDMC's recommendation to continue the study is based on the absence of safety concerns and the encouraging trend in anti-fibrotic effects observed [2][4]

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 ...

LA JOLLA, CA, April 01, 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 pricing of a 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 common stock, short-term ...

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side- effects, limited patient compliance and no impact on survival LA J ...

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side- effects, limited patient compliance and no impact on survival LA J ...