GRI Bio(GRI) - 2025 Q1 - Quarterly Results

GRI Bio First Quarter 2025 Financial Results and Corporate Update Corporate and Clinical Highlights GRI Bio reported positive interim Phase 2a data for GRI-0621 in IPF, strengthened intellectual property, and extended its cash runway with a $5.0 million public offering - Reported positive interim 2-week safety and biomarker results from the ongoing Phase 2a study of GRI-0621 for IPF[1][3][5] - Completed patient enrollment for the 6-week interim analysis (n=24) and has enrolled over two-thirds of the total trial participants[1][5] - Strengthened its global intellectual property portfolio with the granting of patents in Europe and Japan[5] - Closed a $5.0 million public offering, extending the company's cash runway[5][11] Clinical Program Update: GRI-0621 for IPF The Phase 2a study of GRI-0621 for IPF demonstrated safety and tolerability in early patients, with interim biomarker data suggesting an anti-fibrotic effect - GRI-0621 is a small molecule RAR-βɣ dual agonist designed to inhibit iNKT cell activity for treating IPF, a chronic progressive pulmonary disease with limited treatment options[5][6] - A pre-planned interim analysis of the first 12 patients showed GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated, with no hyperlipidemia observed at the 2-week visit[7] - Interim biomarker results from the first 12 subjects showed a change from baseline in PRO-C3 that is suggestive of an anti-fibrotic effect, leading the IDMC to recommend the study continue as planned[8] Upcoming Milestones GRI Bio anticipates reporting significant data from its Phase 2a trial of GRI-0621 in the second and third quarters of 2025, marking key catalysts for the program - Q2 2025: Report 6-week interim results from the Phase 2a biomarker study[11] - Q3 2025: Report topline results from the Phase 2a biomarker study[9][11] First Quarter 2025 Financial Results GRI Bio reported a $3.0 million net loss for Q1 2025, with increased R&D and G&A expenses, and an extended cash runway through Q3 2025 after a $5.0 million public offering Key Financial Metrics | Financial Metric | Q1 2025 | | :--- | :--- | | Net Loss | $3.0 million | | Cash and Cash Equivalents (as of Mar 31) | $3.3 million | Operating Expenses | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research & Development | $1.6 million | $0.9 million | | General & Administrative | $1.4 million | $1.0 million | - The company's existing cash, supplemented by a subsequent $5.0 million public offering, is expected to fund operations and capital expenditures through Q3 2025[1][11][12] Company Overview GRI Bio is a clinical-stage biopharmaceutical company developing NKT cell-targeted therapies for inflammatory, fibrotic, and autoimmune diseases, with lead program GRI-0621 for IPF - GRI Bio is a clinical-stage biopharmaceutical company focused on modulating Natural Killer T (NKT) cells to treat inflammatory, fibrotic, and autoimmune diseases[2][13] - The lead program, GRI-0621, is an oral inhibitor of type 1 invariant NKT (iNKT) cell activity being developed for Idiopathic Pulmonary Fibrosis (IPF)[13] - The company's pipeline also includes novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus and is supported by a proprietary library of over 500 compounds[13]