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LA JOLLA, CA - GRI Bio, Inc. (NASDAQ:GRI), a biotech firm specializing in Natural Killer T (NKT) cell modulators, has announced encouraging interim biomarker results from its Phase 2a study of GRI-0621, a treatment for Idiopathic Pulmonary Fibrosis (IPF). The Independent Data Monitoring Committee (IDMC) has recommended the study continue without modifications, citing no safety concerns from the data reviewed. According to InvestingPro data, GRI maintains a healthy balance sheet with more cash than debt and a strong current ratio of 3.43x, providing adequate runway for its clinical programs.
The IDMC’s examination of initial data from the first 12 subjects at two weeks indicates a potential anti-fibrotic effect of GRI-0621 compared to placebo. The interim findings suggest a favorable trend, although the data is preliminary and from a small cohort. Marc Hertz, PhD, CEO of GRI Bio, expressed optimism about the early safety data and the drug’s potential benefits for patients. The company’s stock has shown significant volatility, with InvestingPro analysis indicating current undervaluation relative to its Fair Value, despite experiencing a challenging market performance with a 98% decline over the past year.
The study has reached full enrollment for its 6-week interim analysis and has completed over two-thirds of total enrollment, with interim data expected in Q2 2025 and topline data in Q3 2025. The double-blind, placebo-controlled trial is set to enroll approximately 36 subjects, who will receive either GRI-0621 or a placebo in a 2:1 ratio.
Safety and tolerability are the primary endpoints, with secondary endpoints including changes in serum biomarkers, pharmacokinetics, and pharmacodynamics of the drug. Additionally, the study will explore the impact of GRI-0621 on pulmonary function, flow cytometry, and differential gene expression.
Previous 2-week safety results indicated that GRI-0621 was well-tolerated, and there were no significant changes in lipid levels among the patients. These results align with the toxicity profile from prior studies involving oral tazarotene, a related compound.
GRI Bio focuses on developing therapies to interrupt disease progression in inflammatory, fibrotic, and autoimmune diseases by targeting NKT cell activity. Its lead program, GRI-0621, aims to inhibit iNKT cell activity as an oral therapeutic option for IPF.
This article is based on a press release statement. For further details on the ongoing Phase 2a study, refer to clinicaltrials.gov with identifier NCT06331624. Investors should note that GRI Bio’s next earnings report is scheduled for May 15, 2025. InvestingPro subscribers have access to 15 additional ProTips and comprehensive financial metrics to better evaluate the company’s potential.
In other recent news, GRI Bio, Inc. has made several notable announcements that could impact its future operations. The company reported positive interim safety data from its Phase 2a study of GRI-0621, a potential treatment for idiopathic pulmonary fibrosis (IPF). The study’s interim analysis revealed that the drug was safe and well-tolerated, with no significant changes in lipid levels among the initial 12 patients, prompting the Independent Data Monitoring Committee to recommend the trial’s continuation without modifications. In financial updates, GRI Bio announced a $5 million public offering, comprising 1,388,888 shares of common stock and Series Warrants, with potential additional proceeds if all warrants are exercised.
Additionally, GRI Bio has secured two global patents, one in Europe for GRI-0803 and another in Japan, both aimed at advancing its NKT cell modulator programs for inflammatory and autoimmune diseases. The company also announced a change in its independent registered public accounting firm, appointing WithumSmith+Brown, PC as its new auditor for the fiscal year ending December 31, 2025. The transition was not due to any disagreements with the previous auditor, Sadler Gibb & Associates LLC. H.C. Wainwright has maintained a Buy rating on GRI Bio, with a $10 price target, reflecting confidence in the potential of GRI-0621 based on the promising safety data from the ongoing study. These developments reflect GRI Bio’s continued efforts to enhance its financial standing and expand its therapeutic portfolio.
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