GRI

Phase 2a data show zero cough and 60% lower treatment-related diarrhea than placebo despite higher nintedanib use in the active arm – suggesting GRI-0621 may mitigate nintedanib-related GI-toxicities when used in combination Advancing GRI-0803 toward IND-enabling activities to expand the pipeline across autoimmune indications with high unmet need LA JOLLA, CA, May 14, 2026 (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 reported financial results for the quarter ended March 31, 2026 and provided a corporate update. “The growing body of Phase 2a clinical, translational and biomarker data continues to reinforce GRI-0621’s differentiated therapeutic potential in idiopathic pulmonary fibrosis (IPF),” said Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Additional analyses in the Phase 2a study show that GRI-0621 delivered zero cough, reduced dyspnea, zero weight loss and approximately 60% less treatment-related diarrhea when added to standard of care versus standard of care alone, with no serious adverse events in the active arm – directly addressing the tolerability burdens that drive discontinuations of current IPF therapies. These data, together with improvements in lung function and consistent evidence of immune modulation, anti-fibrotic activity, and epithelial repair, give us confidence in the program. With approximately $11.0 million in cash as of March 31, 2026, supporting planned operations into the second quarter of 2027, we believe we are positioned to continue advancing GRI-0621 towards pivotal studies and progressing GRI-0803 toward IND-enabling activities with disciplined execution.” Phase 2a Data – GRI-0621 in IPF GRI-0621, the Company’s once-daily oral RARβ/γ selective agonist, was evaluated in a randomized, double-blind, placebo-controlled Phase 2a trial (GRI-0621-IPF-02; NCT06331624) in 35 patients with IPF, approximately 80% of whom were on background standard-of-care (SOC) antifibrotics. The trial met its primary safety and tolerability endpoint, with continued analyses of translational and biomarker endpoints supporting previously reported findings. Key results include: Safety and tolerability: GRI-0621 was observed to reduce...

Company reported $8.2 million in cash and cash equivalents at December 31, 2025 and raised additional $6.5 million in gross proceeds in January 2026 Balance sheet strengthened to fund operations into Q1 2027 Strong Phase 2a clinical data for GRI-0621 in idiopathic pulmonary fibrosis reinforce clinical proof-of-concept and therapeutic differentiation GRI-0803 focused on autoimmune indications with high unmet need advancing through IND-enabling activities LA JOLLA, CA, Feb. 04, 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 summarized recently reported Full Year 2025 financial results, provided an update on the Company’s current cash position and cash runway and summarized key clinical and corporate highlights. “In 2025, we prioritized disciplined clinical execution and balance sheet strength, delivering compelling clinical data from our lead IPF program which underscores the therapeutic differentiation of GRI-0621,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Entering 2026 with a strong cash position, we are focused on advancing GRI-0621 in IPF, progressing GRI-0803 toward the clinic and executing our clinical strategy with capital discipline to drive long-term value creation.” Recent Highlights Raised approximately $14.5 in gross proceeds in December 2025 and January 2026 Strong cash position expected to fund planned operations into the first quarter of 2027 Announced positive Phase 2a topline data from the completed Phase 2a clinical study of GRI-0621 in idiopathic pulmonary fibrosis Reported additional data demonstrating suppression of pro-fibrotic immune phenotypes, reinforcing topline data and clinical proof-of-concept Generated new RNA-sequencing gene expression data demonstrating direct impact on the core biology of fibrosis and lung repair Advanced plans to progress GRI-0803 into IND-enabling studies, expanding the Company’s pipeline in autoimmune disease Summary of Financial Results for the Year Ended December 31, 2025 As of December 31, 2025, the Company had cash and cash equivalents of approximately $8.2 million. Following the close of the quarter, the Company raised an additional $6.5 million in gross proceeds through the use of its At Th...

The Independent Data Monitoring Committee (“IDMC”) has recommended to continue the study as planned as there are no safety concerns demonstrated in the data reviewed Interim results to date demonstrate GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated 6-week interim biomarker data (n=24) expected in July 2025 and topline data expected in 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 JOLLA, CA, June 26, 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 reported positive 6-week interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of IPF. GRI-0621 is the Company’s small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (“iNKT”) cells. In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. The pre-planned interim analysis for 6-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 24 patients evaluated per protocol. There were no adverse events associated with hyperlipidemia, as assessed by LDL, HDL and triglyceride (“TG”) levels in the 24 patients assessed at the 6-week visit. There were no clinically meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, consistent with the safety data reported after the first 12 subjects completed 2-weeks of treatment, and all subjects remained within protocol accepted ranges. The interim analysis committee recommended the study should continue as planned. The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks. Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, “We are happy to report the IDMC confirmed no safet...

Data presented at the 2025 American Thoracic Society (ATS) International Conference Pre-clinical and interim clinical results underscore GRI-0621’s potential to have both anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis Results from 6-week interim analysis (n=24) in ongoing Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) anticipated in Q2 2025 LA JOLLA, CA, May 22, 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 presentation of positive preclinical data demonstrating its lead program GRI-0621 has anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis. The data was presented by Marc Hertz, PhD, Chief Executive Officer of GRI Bio in the poster titled, “Inactivation of iNKT Cells After the Inflammatory Phase Leads to Significant Inhibition of Fibroblast Activation and Fibrosis in a Model of Pulmonary Fibrosis,” as part of the D21 - IMMUNOLOGICAL INSIGHTS IN LUNG INFLAMMATION AND REPAIR session at the 2025 ATS International Conference held on Wednesday, May 21, 2025. “We continue believe GRI-0621 is a promising potential treatment option for IPF, an indication where there remains significant unmet need. Our growing body of pre-clinical results continue to bolster our understanding of the role of iNKT cell activity in driving pulmonary fibrosis and further support our ongoing Phase 2a study examining the safety and tolerability of GRI-0621 and its effect on various biomarkers in IPF patients. We remain encouraged by the progress made in our Phase 2a biomarker study and look forward to reporting additional data this year,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. The presented data highlights results from biochemical, qPCR and immunohistochemistry analyses, used to investigate whether iNKT cell inactivation during the fibrotic phase resolves lung injury, fibroblast activation, and fibrosis in the murine bleomycin model of pulmonary fibrosis. Key Highlights In a therapeutic regimen of the bleomycin-induced fibrosis model, orally administered GRI-0621 after completion of the inflammatory phase (Day 7), significantly inhibits lung injury and several important fi...

Positive interim 2-week safety and biomarker results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”) Continued momentum with completed patient enrollment for the 6-week interim analysis (n=24) and over two-thirds enrollment completed for the overall trial Cash runway expected to fund operations through Q3 2025 LA JOLLA, CA, May 15, 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 reported its financial results for the quarter ended March 31, 2025 and provided a corporate update. “We continue to make very encouraging progress with our ongoing Phase 2a trial of our lead program, GRI-0621. Based on the positive interim safety and biomarker data observed in the first 12 patients at 2 weeks, the current momentum with patient enrollment, and the additional data readouts anticipated this year, we believe we are well-positioned to build near- and long-term value for shareholders,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. Recent Highlights Reported interim biomarker data demonstrating a positive trend towards an anti-fibrotic effect of GRI-0621 in first 12 patients of ongoing Phase 2a study in IPF; Reported interim biomarker data demonstrating a positive trend towards an anti-fibrotic effect of GRI-0621 in first 12 patients of ongoing Phase 2a study in IPF; Completed patient enrollment for the 6-week interim analysis (n=24) and completed over two-thirds of enrollment for the overall trial; Completed patient enrollment for the 6-week interim analysis (n=24) and completed over two-thirds of enrollment for the overall trial; Reported encouraging interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of IPF; Reported encouraging interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of IPF; Announced its abstract was selected for poster discussion at the 2025 American Thoracic Society (ATS) International Conference; Announced its abstract was selected for poster discussion at the 2025 American Thoracic Society (ATS) International Conference; Bolstered global intellectual property portfolio with granting of...

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 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 reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”). GRI-0621, is the Company’s small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (“iNKT”) cells. In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit. There were no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, and all subjects remained within normal ranges. The interim analysis committee recommended the study should continue as planned. The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks. Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, “While preliminary, in the first 12 subjects evaluated these results are encouraging and in line with our expectations. We believe these results, particularly the safety data, underscore GRI-0621’s potential to provide a muc...

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 financial results for the fiscal year ended December 31, 2024 and today provided a corporate update. “Over the last year, we made significant progress on the development of our lead program GRI-0621 for the treatment of IPF. We continue to make strides towards our anticipated interim data readout and topline data readout which remain on track for the second and third quarter of 2025, respectively. We remain confident that the data observed to date, and the additional data readouts anticipated this year, will position us to build momentum and drive value for shareholders in the near and long term,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. Recent Highlights Presented positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in IPF at the 8th Annual Antifibrotic Drug Development Summit; and Presented positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in IPF at the 8th Annual Antifibrotic Drug Development Summit; and Granted European patent covering GRI-0803 and the Company’s library of 500+ proprietary compounds. Granted European patent covering GRI-0803 and the Company’s library of 500+ proprietary compounds. GRI-0621: Type 1 Invariant NKT (“iNKT”) Antagonist in Development for the Treatment of IPF. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on overall survival1, leaving significant opportunity to augment IPF treatment with a new therapeutic. GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In pre...