GRI Bio Stock Price, News & Analysis

GRI Bio (NASDAQ: GRI) reported encouraging interim biomarker results from its Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF). The Independent Data Monitoring Committee (IDMC) found that the first 12 patients showed a positive trend towards anti-fibrotic effects, with no safety concerns. The company has completed enrollment for the 6-week interim analysis (N=24) and achieved over 70% total enrollment. The Phase 2a study is a randomized, double-blind trial evaluating GRI-0621 4.5mg versus placebo in approximately 36 IPF patients. Key timelines include interim data expected in Q2 2025 and topline results in Q3 2025. Initial 2-week safety results showed GRI-0621 to be well-tolerated, with no hyperlipidemia observed and lipid levels remaining within normal ranges.

GRI Bio (NASDAQ: GRI) has announced significant progress in its Phase 2a clinical trial of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF). The study has completed enrollment for the 6-week interim analysis with 24 out of 36 planned patients now enrolled. The randomized, double-blind study administers GRI-0621 4.5mg or placebo orally once daily for 12 weeks. Previously reported 2-week safety results from the first 12 patients showed the drug to be safe and well-tolerated, with no hyperlipidemia observed. The company expects to report interim biomarker data in Q2 2025 and topline results in Q3 2025. The study's primary endpoint focuses on safety and tolerability, with secondary endpoints including changes in serum biomarkers and pharmacokinetics assessment.

GRI Bio (NASDAQ: GRI) announced that its abstract has been selected for a poster discussion session at the 2025 American Thoracic Society (ATS) International Conference in San Francisco, CA, from May 18-21, 2025. The presentation, titled 'Inactivation of iNKT Cells After the Inflammatory Phase Leads to Significant Inhibition of Fibroblast Activation and Fibrosis in a Model of Pulmonary Fibrosis,' will be delivered by CEO Marc Hertz, PhD.

The presentation is scheduled for Wednesday, May 21, 2025, from 8:15-10:15 AM PT in Room 2022/2024 at the Moscone Center. It will be part of the session 'D21 - IMMUNOLOGICAL INSIGHTS IN LUNG INFLAMMATION AND REPAIR' and will be displayed on Poster Board Number 810.

GRI Bio (NASDAQ: GRI) has successfully closed its previously announced public offering, raising $5.0 million in gross proceeds. The offering included 1,388,888 shares of common stock along with three series of warrants (E-1, E-2, and E-3) at a combined price of $3.60 per share.

The warrants, exercisable immediately at $3.20 per share, have varying expiration periods: Series E-1 expires in 5 years, Series E-2 in 18 months, and Series E-3 in 9 months. If fully exercised, these warrants could generate additional gross proceeds of $13.3 million.

H.C. Wainwright & Co. served as the exclusive placement agent. The biotechnology company, focused on developing Natural Killer T cell modulators for inflammatory, fibrotic and autoimmune diseases, plans to use the net proceeds for product candidate development, working capital, and general corporate purposes.

GRI Bio (NASDAQ: GRI) has announced the pricing of a $5.0 million public offering consisting of 1,388,888 shares of common stock (or equivalents) and three series of warrants. The offering is priced at $3.60 per share with accompanying Series E-1, E-2, and E-3 warrants.

The warrants have an exercise price of $3.20 per share, with varying expiration periods: Series E-1 expires in 5 years, Series E-2 in 18 months, and Series E-3 in 9 months. If fully exercised, the warrants could generate additional gross proceeds of $13.3 million.

The offering, managed by H.C. Wainwright & Co. as exclusive placement agent, is expected to close around April 2, 2025. The company plans to use the proceeds for product candidate development, working capital, and general corporate purposes.

GRI Bio (NASDAQ: GRI) has reported encouraging interim safety results from its ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The Independent Data Monitoring Committee recommended continuing the study as planned, with no safety concerns identified in the first 12 patients evaluated.

The study evaluates GRI-0621, a RAR-βɣ dual agonist administered at 4.5mg orally once daily. Initial results show the drug is safe and well-tolerated, with no hyperlipidemia observed in the assessed patients. The Phase 2a trial will enroll approximately 36 subjects in a 2:1 ratio (GRI-0621 vs. placebo) for a 12-week treatment period.

The study's primary endpoint focuses on safety and tolerability, with secondary endpoints including changes in serum biomarkers and pharmacodynamic activity. Interim biomarker data is expected in Q2 2025, with topline results anticipated in Q3 2025.

GRI Bio (NASDAQ: GRI) has strengthened its intellectual property portfolio with two significant patent grants in Europe and Japan. The European patent covers GRI-0803, a novel activator of type 2 diverse NKT cells being developed for autoimmune disorders, particularly systemic lupus erythematosus. The Japanese patent focuses on methods for modulating dNKT and iNKT cells in treating inflammatory conditions through Retinoic Acid Receptor agonists.

The company's lead program, GRI-0621, is currently in a Phase 2a clinical trial for idiopathic pulmonary fibrosis (IPF). Interim data is expected in Q2 2025, with topline results anticipated in Q3 2025. The study is designed as a randomized, double-blind, multi-center, placebo-controlled trial.

GRI Bio (NASDAQ: GRI) announced its President and CEO Marc Hertz's participation in a Virtual Investor CEO Connect segment. During the presentation, Dr. Hertz discussed the company's lead program, GRI-0621, which targets Idiopathic Pulmonary Fibrosis (IPF), a rare chronic progressive fibrosing interstitial lung disease with treatment options.

The company highlighted upcoming milestones, including interim data expected at the beginning of next quarter and topline data in the subsequent quarter. The presentation is now available for viewing online through Virtual Investor's platform.

GRI Bio (NASDAQ: GRI) has reported its financial results for fiscal year 2024 and provided updates on its lead program GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) treatment. The company anticipates key data readouts in 2025, with interim data expected in Q2 and topline results in Q3 from its Phase 2a biomarker study.

Financial highlights include:

• Net loss of $8.2 million for 2024
• R&D expenses increased to $3.8 million from $3.2 million in 2023
• G&A expenses decreased to $4.5 million from $8.2 million in 2023
• Cash position of $5.0 million as of December 31, 2024

Recent achievements include presenting positive preclinical data showing GRI-0621 reduces inflammatory and fibrotic drivers in IPF, and receiving a European patent for GRI-0803. The company's cash runway is expected to fund operations into Q2 2025.