LA JOLLA, CA, Dec. 12, 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 10,666,667 shares of its common stock (or common stock equivalents in lieu thereof), Series F warrants to purchase up to 10,666,667 shares of com ...

Core Viewpoint - GRI Bio, Inc. has announced a public offering of 10,666,667 shares of common stock and Series F warrants, aiming to raise approximately $8 million for product development and general corporate purposes [1][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 [6]. - 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 [6]. - 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 [6]. Offering Details - The public offering is priced at $0.75 per share, with Series F warrants exercisable at the same price, expiring five years after issuance [1]. - The offering is expected to close around December 12, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2]. Financial Implications - The gross proceeds from the offering are anticipated to be approximately $8 million before deducting fees and expenses [3]. - If fully exercised, the Series F warrants could provide an additional $8 million in gross proceeds [3].

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]