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 ...

Company committed to building a robust global patent estate across its innovative pipeline of NKT cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases LA JOLLA, CA, March 31, 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 granting of two global patents. T ...

Financial Results Announcement - GRI Bio, Inc. announced its financial results for the year ended December 31, 2024, on March 17, 2025[5]. - A press release detailing the financial results was issued as Exhibit 99.1[7]. - The report does not include specific financial metrics or performance indicators in the provided content[6]. - No specific user data, future outlook, or guidance was provided in the available content[6]. Company Classification and Trading - The company is classified as an emerging growth company under the Securities Act of 1933[4]. - The common stock of GRI Bio, Inc. is traded on The Nasdaq Capital Market under the symbol GRI[3]. - The report indicates that the information is not deemed "filed" for purposes of the Securities Exchange Act of 1934[6]. Company Information - The company is headquartered in La Jolla, CA, with a principal executive office address at 2223 Avenida de la Playa, Suite 208[3]. - The Chief Financial Officer, Leanne Kelly, signed the report on behalf of GRI Bio, Inc.[10]. Product and Market Activity - There are no mentions of new products, technologies, market expansion, or acquisitions in the provided documents[6].

Interim data and topline data readouts from Phase 2a biomarker study expected in Q2 2025 and Q3 2025, respectively Cash runway expected to fund operations into Q2 2025, including interim data readout from GRI-0621 LA JOLLA, CA, March 17, 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, has reported its fi ...

Core Insights - GRI Bio, Inc. is advancing its lead program GRI-0621, a treatment for idiopathic pulmonary fibrosis (IPF), with interim data expected in Q2 2025 and topline data in Q3 2025 [1][2][11] - The company reported a net loss of $8.2 million for the fiscal year ended December 31, 2024, with research and development expenses increasing to $3.8 million [6][8] - GRI Bio's cash and cash equivalents as of December 31, 2024, were approximately $5.0 million, expected to fund operations into Q2 2025 [8] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for inflammatory, fibrotic, and autoimmune diseases [1][12] - The lead program GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity, showing promise in improving fibrosis and liver function in preliminary trials [4][12] - The company is also developing a pipeline of novel type 2 diverse NKT agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds [12] Financial Performance - Research and development expenses increased by $0.6 million from 2023 to 2024, primarily due to the registrational development program for GRI-0621 [6] - General and administrative expenses decreased by $3.7 million from 2023 to 2024, attributed to reduced fees related to a merger with Vallon Pharmaceuticals, Inc. [7] - The company believes its existing cash will be sufficient to fund operations through Q2 2025, including the interim data readout from GRI-0621 [8]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-40034 GRI BIO, INC. (Exact name of registrant as specified in its charter) | Delaware | | 82-4369909 | | | --- | -- ...

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 [2] - The company's lead program, GRI-0621, is an inhibitor of invariant NKT (iNKT) cell activity, being developed as an oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [2] - GRI Bio is also developing a pipeline of diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [2] Recent Developments - On March 10, 2025, GRI Bio received notice from Nasdaq confirming that it has regained compliance with the minimum bid price rule, which is crucial for maintaining its listing on the exchange [1]

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 [2] - The company's lead program, GRI-0621, is an inhibitor of invariant NKT (iNKT) cell activity, being developed as an oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [2] - GRI Bio is also developing a pipeline of diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [2] Recent Developments - On March 10, 2025, GRI Bio received notice from Nasdaq confirming that it has regained compliance with the minimum bid price rule, which is crucial for maintaining its listing on the exchange [1]

Core Viewpoint - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases, highlighting its innovative pipeline and participation in the Virtual Investor "Top 5 for '25" On-Demand Conference [1][2]. Company Overview - GRI Bio is a clinical-stage biopharmaceutical company aiming to transform the treatment of inflammatory, fibrotic, and autoimmune diseases by targeting NKT cells, which play a crucial role in the inflammatory response [3]. - 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, 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 possesses a library of over 500 proprietary compounds to support its growing pipeline [3].