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 ...

GRI Bio, Inc.’s (GRI) shares plummeted 36.9% on April 1 after the company announced the pricing of a public offering of stock of $5 million.Earlier in the day, the stock surged after the company reported positive interim safety results from its ongoing phase IIa study evaluating pipeline candidate GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF).Last month, the company received notice from The Nasdaq Stock Market LLC stating that it regained compliance with Nasdaq’s “minimum bid price rule. ...

Core Viewpoint - GRI Bio, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $5.0 million for product development and general corporate purposes [1][3]. Group 1: Offering Details - The public offering includes 1,388,888 shares of common stock and Series E-1, E-2, and E-3 warrants, all priced at $3.60 per share [1]. - The Series Warrants have an exercise price of $3.20 per share and will be exercisable immediately upon issuance, with varying expiration dates [1]. - The closing of the offering is expected around April 2, 2025, pending customary closing conditions [1]. Group 2: Financial Proceeds - The gross proceeds from the offering are estimated to be approximately $5.0 million before deducting fees and expenses [3]. - If fully exercised, the Series Warrants could provide an additional gross proceeds of approximately $13.3 million [3]. Group 3: Company Overview - GRI Bio is focused on developing therapies targeting Natural Killer T (NKT) cells for treating inflammatory, fibrotic, and autoimmune diseases [6]. - The lead program, GRI-0621, is an inhibitor of iNKT cell activity aimed at treating idiopathic pulmonary fibrosis [6]. - The company has a library of over 500 proprietary compounds to support its growing pipeline [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] - Interim results show GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated, with no significant changes in lipid levels [3] - The company anticipates interim biomarker data in Q2 2025 and topline results 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 [7] - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits human Type 1 Invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [2][7] - The company is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus [7] Study Details - The ongoing Phase 2a study is randomized, double-blind, and placebo-controlled, enrolling approximately 36 subjects with Idiopathic Pulmonary Fibrosis (IPF) [4] - GRI-0621 is administered at a dose of 4.5mg once daily for 12 weeks, with a primary endpoint focused on safety and tolerability [4] - Secondary endpoints include changes in serum biomarkers and pharmacokinetics, with exploratory endpoints assessing pulmonary function and gene expression [4]

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 ...

Core Viewpoint - GRI Bio, Inc. is advancing its innovative pipeline of NKT cell modulators aimed at treating inflammatory, fibrotic, and autoimmune diseases, with recent achievements in expanding its global patent estate [1][2]. Patent Developments - The company has been granted two global patents, enhancing its intellectual property portfolio and supporting its innovative pipeline of over 500 proprietary compounds [2][5]. - The patents include coverage for GRI-0803, a novel activator of human type 2 diverse NKT cells for treating autoimmune disorders, and methods for modulating NKT cells in inflammatory conditions [5]. Clinical Development - GRI Bio is advancing its lead program, GRI-0621, in a Phase 2a clinical trial for idiopathic pulmonary fibrosis (IPF), with interim data expected in Q2 2025 and topline results in Q3 2025 [2][3]. - The company’s therapies target NKT cells to interrupt disease progression and restore immune system balance, addressing significant unmet medical needs [3]. Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on transforming the treatment landscape for inflammatory, fibrotic, and autoimmune diseases through its unique approach to NKT cell modulation [3].

As filed with the Securities and Exchange Commission on March 26, 2025. Registration No. 333-286072 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) Delaware 2834 82-4369909 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Ad ...

As filed with the Securities and Exchange Commission on March 24, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) Delaware 2834 82-4369909 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 2223 Avenida de la Playa, # ...

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 ...