New immune profiling data confirms disease-modifying mechanism, reinforces earlier signals of fibrosis resolution, lung repair, and improved lung function LA JOLLA, CA, Jan. 08, 2026 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of immune cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced positive flow cytometry data from the Phase 2a GRI-0621-IPF-02 clinical trial evalu ...

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 ...

Company Performance - Rezolute, Inc. (NASDAQ:RZLT) experienced a dramatic stock price drop to $1.32, reflecting an 87.93% decrease due to a failed Phase 3 study and subsequent investigation by Holzer & Holzer, LLC [1][6] - Oriental Culture Holding Ltd. (NASDAQ:OCG) saw its stock price decline to $1.57, an 81.95% decrease, potentially influenced by its unaudited financial results for the first half of 2025 [2][6] - C3is Inc. (NASDAQ:CISS) reported a stock price drop to $0.34, a 79.82% decrease, amid broader industry challenges and its financial results for the third quarter [3][6] - GRI Bio, Inc. (NASDAQ:GRI) faced a 54.70% decline in stock price to $0.54, linked to its public offering announcement of $8 million [4][6] - Thunder Power Holdings, Inc. (OTCQB:AIEV) saw its stock price decrease to $0.14, a 49.58% drop, as it reported third-quarter results and plans for asset integration and renewable energy expansion [5] Market Trends - The significant price movements across various sectors, including biotechnology, e-commerce, marine shipping, and electric vehicle manufacturing, indicate heightened volatility in the market [5] - Factors contributing to these declines include company-specific news such as earnings reports and strategic decisions, as well as broader market trends and economic indicators [5]

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. announced positive topline data from the Phase 2a clinical trial of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), demonstrating safety and efficacy in improving lung function and biomarkers of fibrosis resolution [1][9] Group 1: Study Results - The study met its primary endpoint, showing that GRI-0621 was well tolerated over 12 weeks with no severe drug-related adverse events [1][3] - Secondary endpoints indicated improvements in biomarkers of collagen turnover, suggesting fibrosis resolution and repair of the alveolar basement membrane [1][4] - 39% of subjects treated with GRI-0621 experienced an increase in forced vital capacity (FVC) at 12 weeks, contrasting with 80% of placebo subjects who experienced a decline [1][10] Group 2: Safety Profile - No significant safety or tolerability concerns were reported, with common adverse events being dry skin, dry lips, and muscle and joint pain [3] - There were no increases in cough or gastrointestinal disorders in the GRI-0621 group compared to the placebo group [3] Group 3: Biomarker Improvements - Serum biomarkers indicated a decrease in PRO-C6 (a type VI collagen synthesis biomarker) by 3% in GRI-0621 treated subjects, while it increased by 12% in the placebo group [4] - Type IV collagen synthesis (PRO-C4) increased by 9% in GRI-0621 treated subjects, while it decreased by 2% in the placebo group [5] Group 4: Mechanistic Insights - GRI-0621 was shown to reduce neutrophil and macrophage activity, which are associated with disease progression in IPF [8] - Differential gene expression data indicated that GRI-0621 significantly reduced DLK1, a gene involved in lung epithelial cell regeneration, supporting the alveolar basement membrane repair mechanism [7] Group 5: Future Outlook - The positive results from the Phase 2a trial are seen as a significant milestone for GRI Bio's IPF program, with potential implications for advancing treatment options in a disease with limited therapies [9] - GRI-0621's favorable safety profile and its ability to improve biomarkers suggest it could represent a meaningful advance in the treatment landscape for IPF [9]

As filed with the Securities and Exchange Commission on December 9, 2025. Registration No. 333-291999 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) (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) 2223 Avenida de la Playa, #208 La Jolla, CA 92037 (619) 400-117 ...

As filed with the Securities and Exchange Commission on December 8, 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) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) (State or other jurisdiction of incorporation or organization) 2223 Avenida de la Playa, #208 La Jolla, CA 92037 ...

As filed with the Securities and Exchange Commission on December 8, 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) (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) (State or other jurisdiction of incorporation or organization) 2223 Avenida de la Playa, ...

Product Development - GRI-0621, the lead product candidate, has been evaluated in over 1,700 patients for up to 52 weeks, targeting severe fibrotic lung diseases like idiopathic pulmonary fibrosis (IPF), which affects approximately 140,000 people annually in the U.S.[77] - The company expects to release topline results from the Phase 2a biomarker study of GRI-0621 by the end of November 2025[78] - The company has received FDA clearance for its Investigative New Drug application and authorization for clinical trials in the U.S., U.K., and Australia for GRI-0621[78] - The company plans to focus on developing GRI-0803 for autoimmune disorders, pending additional funding and IND clearance, with an expected Phase 1a and 1b trial in 2026[80] - The company has a proprietary library of over 500 compounds, with GRI-0803 being the lead molecule for the treatment of autoimmune disorders like lupus and multiple sclerosis[79] Financial Performance - Total operating expenses for the three months ended September 30, 2025, were $3.4 million, up from $2.1 million in 2024, resulting in a loss from operations of $3.4 million[94] - The company reported a net loss of $3.4 million for the three months ended September 30, 2025, compared to a net loss of $2.1 million in the same period of 2024[94] - Research and development expenses increased to $5.2 million for the nine months ended September 30, 2025, up 80.8% from $2.9 million in 2024[100] - General and administrative expenses rose to $4.1 million for the nine months ended September 30, 2025, an increase of 20.6% from $3.4 million in 2024[101] - The net loss for the nine months ended September 30, 2025, was $9.3 million, compared to a net loss of $6.3 million in 2024, reflecting a 48% increase in losses[104] - Cash used in operating activities was $7.2 million for the nine months ended September 30, 2025, compared to $6.6 million in 2024, indicating a 9.1% increase in cash outflow[106] Funding and Cash Position - The company has raised $6.2 million in gross proceeds from the At The Market Offering, selling 1,680,099 shares at a weighted-average price of $3.67 per share[86] - Net cash provided by financing activities was $6.2 million for the nine months ended September 30, 2025, down from $9.6 million in 2024, a decrease of 35.4%[107][108] - As of September 30, 2025, the company had $4.1 million in cash and an accumulated deficit of $49.0 million[104][113] - The company expects to continue incurring significant operating losses and will need to secure additional funding to support ongoing operations and clinical trials[115] - The company plans to raise capital through additional equity securities and/or debt arrangements, but there are no assurances that financing will be available on acceptable terms[115] Expense Analysis - Research and development expenses increased to $1.8 million for the three months ended September 30, 2025, compared to $1.1 million in the same period of 2024, reflecting a $0.5 million rise in GRI-0621 registration development costs[95] - General and administrative expenses rose to $1.6 million for the three months ended September 30, 2025, from $1.0 million in 2024, primarily due to a $0.5 million increase in personnel expenses[96] - Interest income for the nine months ended September 30, 2025, was $16,000, a decrease of 15.8% from $19,000 in 2024[103]

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]