GRI Bio (GRI) investor relations material

Program updates and clinical milestones

• Lead program GRI-0621 is in a Phase 2A study for idiopathic pulmonary fibrosis (IPF), with top-line data expected later this month.

• GRI-0803, focused on systemic lupus erythematosus, will advance through IND and Phase 1 next year.

• Additional clinical-stage assets and a pipeline of 500 proprietary compounds are available for future development.

• Positive interim data for GRI-0621 after two and six weeks of therapy in IPF patients.

• Next steps may include a Phase 2B pivotal study if current results are successful.

Scientific insights and technology platform

• NKT cell modulators regulate both adaptive and innate immune responses, offering a selective approach to immunomodulation.

• Elevated NKT cell levels correlate with disease progression in IPF, lupus, and other fibrotic conditions.

• GRI-0621 targets key fibrotic pathways, including TGF beta and IL-13, to inhibit fibrosis.

• Preclinical models show GRI-0621 outperforms nintedanib in reducing fibrosis and related biomarkers.

• GRI-0803 activates regulatory dNKT cells, showing efficacy in lupus animal models.

Clinical study design and biomarker analysis

• Phase 2A IPF study enrolled 36 patients, allowing background therapy with approved drugs.

• Primary endpoint is safety, with extensive biomarker, gene expression, and flow cytometry analysis.

• Serum biomarkers of collagen synthesis and degradation provide early insight into fibrosis progression or resolution.

• Data show decreased collagen synthesis, increased degradation, and signs of lung repair.

• Biomarker and gene expression data will inform the design of future studies.