VALLON PHARMACEU(VLON) - 2025 Q1 - Quarterly Results

GRI Bio Reports First Quarter 2025 Financial Results and Corporate Update GRI Bio reported Q1 2025 results, highlighting positive interim Phase 2a data for GRI-0621 in IPF and extended cash runway Corporate Update and Recent Highlights GRI Bio reported Q1 2025 results, highlighting positive interim Phase 2a data for GRI-0621 in IPF and extended cash runway - The ongoing Phase 2a trial of lead program GRI-0621 is showing encouraging progress based on positive interim safety and biomarker data from the first 12 patients[3] - Key recent achievements include positive interim trial data, completion of patient enrollment for the 6-week interim analysis (n=24), securing new patents in Europe and Japan, and closing a $5.0 million public offering[5] - The company's cash runway is expected to fund operations through Q3 2025[1] Clinical Program Update This section details the clinical development of GRI-0621 for IPF, including its mechanism, positive Phase 2a interim results, and future milestones GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) GRI-0621 is an oral, small molecule iNKT cell inhibitor for IPF, showing potential to improve fibrosis and favorable safety in Phase 2a - IPF is a rare, chronic, progressive pulmonary disease with limited treatment options that have significant side-effects and no impact on overall survival[5][6] - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells, which play a key role in inflammation and fibrosis[6] Phase 2a Trial Interim Results Interim analysis of GRI-0621's Phase 2a study showed a positive safety profile and encouraging biomarker data, leading to study continuation - A 2-week safety analysis in the first 12 patients showed GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated, with no hyperlipidemia observed (no meaningful changes in HDL, LDL, or triglyceride levels)[7] - Interim biomarker results from the first 12 subjects at 2 weeks showed a change in PRO-C3 levels suggestive of an anti-fibrotic effect compared to placebo[8] - Based on the interim data, the IDMC recommended the Phase 2a study continue as planned, citing no safety concerns[8] Expected GRI-0621 Upcoming Milestones GRI Bio anticipates reporting further key data from the GRI-0621 Phase 2a trial in upcoming quarters of 2025, serving as critical catalysts GRI-0621 Phase 2a Trial Milestones | Timeline | Milestone | | :--- | :--- | | Q2 2025 | Report 6-week interim results from Phase 2a biomarker study | | Q3 2025 | Report topline results from Phase 2a biomarker study | Summary of Financial Results for First Quarter 2025 This section summarizes GRI Bio's Q1 2025 financial performance, including net loss, expenses, and cash position Q1 2025 Financial Performance In Q1 2025, GRI Bio reported a $3.0 million net loss, increased expenses, and extended its cash runway through Q3 2025 after a $5.0 million offering Key Financial Metrics (Millions USD) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss | $3.0 million | N/A | | Research & Development Expenses | $1.6 million | $0.9 million | | General & Administrative Expenses | $1.4 million | $1.0 million | - As of March 31, 2025, the company held approximately $3.3 million in cash and cash equivalents[11] - Subsequent to the quarter's end, the company raised an additional $5.0 million in gross proceeds from a public offering, extending its cash runway through Q3 2025[11][12] Corporate Information This section provides an overview of GRI Bio's therapeutic focus and includes a standard disclaimer regarding forward-looking statements About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company targeting NKT cells for inflammatory, fibrotic, and autoimmune diseases, with lead program GRI-0621 for IPF - GRI Bio's therapeutic approach is to target NKT cells, which are key regulators in the inflammatory cascade, to interrupt disease progression[13] - The company's pipeline includes GRI-0621 (an iNKT inhibitor for IPF) and novel type 2 dNKT agonists for systemic lupus erythematosus[13] Forward-Looking Statements This section cautions that the press release contains forward-looking statements subject to risks, and interim data may not be representative of final results - The press release contains forward-looking statements concerning clinical trial timelines, product candidate potential, and financial performance, which are subject to inherent risks and uncertainties[14] - The company specifically warns that the interim data discussed may not be indicative of later or final data for the trial, as additional clinical testing is required[15]