GRI Bio reports progress in pulmonary fibrosis treatment

LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a biotechnology company focused on inflammatory, fibrotic, and autoimmune diseases, has revealed positive preclinical data for its lead drug candidate GRI-0621, showing potential anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis. The micro-cap company, currently valued at $720,000, maintains a healthy balance sheet with more cash than debt according to InvestingPro data, though it faces significant financial challenges with its stock down over 90% year-to-date. The findings were presented at the American Thoracic Society International Conference on Wednesday, with a focus on the drug’s impact on a murine model of the disease.

Marc Hertz, PhD, CEO of GRI Bio, shared the results, which indicated that GRI-0621, when administered orally, significantly inhibited lung injury and fibrotic drivers such as fibroblast activation in the model. The drug also impacted innate and adaptive cell activity, cytokine production, and myofibroblast activation.

GRI-0621, a small molecule RAR-βγ dual agonist inhibiting human iNKT cells, is currently under a 12-week Phase 2a study to assess safety, tolerability, and biomarker effects in patients with Idiopathic Pulmonary Fibrosis (IPF). Early interim results from the ongoing study have shown that GRI-0621 is safe and well-tolerated at a 4.5mg oral dose once daily, with no significant changes in lipid profiles observed.

The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the Phase 2a study, citing no safety concerns and early biomarker results suggestive of an anti-fibrotic effect. Topline results from the study are anticipated in the third quarter of 2025. Analysts maintain optimistic price targets ranging from $10 to $40 per share, significantly above current trading levels, though InvestingPro analysis suggests the company is unlikely to achieve profitability this year.

GRI Bio aims to address significant unmet medical needs in the treatment of IPF and other diseases by targeting NKT cell activity. The company’s pipeline includes a range of NKT cell modulators and a library of over 500 proprietary compounds.

This article is based on a press release statement from GRI Bio, Inc. The information presented is factual and provides an update on the company’s ongoing research and clinical trials. It is important to note that the data discussed is interim and additional study is required to support the continued development of GRI-0621. With a current ratio of 1.41 and an overall financial health score rated as ’WEAK’ by InvestingPro, investors should carefully consider the company’s financial position. For deeper insights into GRI Bio’s financial metrics and 8 additional ProTips, explore InvestingPro’s comprehensive analysis platform.

In other recent news, GRI Bio has reported positive interim results from its Phase 2a study of GRI-0621, a treatment for Idiopathic Pulmonary Fibrosis (IPF), showing that the drug was safe and well-tolerated in the initial 12 patients. The Independent Data Monitoring Committee (IDMC) recommended the study continue without modifications, citing encouraging safety and biomarker data. Additionally, GRI Bio announced a net loss of $3.0 million for the first quarter of 2025, with research and development expenses at $1.6 million. The company recently completed a $5 million public offering, which is expected to fund operations through the third quarter of 2025.

In another development, GRI Bio has changed its independent registered public accounting firm, appointing WithumSmith+Brown, PC as the new auditor. There were no disagreements with the previous auditor, Sadler Gibb & Associates LLC, on accounting principles or practices. H.C. Wainwright has maintained a Buy rating on GRI Bio, with a $10 price target, following the positive interim safety data. The firm highlighted the drug’s safety profile as a significant factor in its potential success. GRI Bio’s ongoing efforts to advance IPF treatment include securing patents in Europe and Japan and preparing to present at the 2025 American Thoracic Society International Conference.

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