GRI Bio (GRI) Corporate Connect Webinar Series summary

Key presentations and program updates

• GRI Bio presented its pipeline of immune modulators targeting inflammatory, fibrotic, and autoimmune diseases, highlighting an oral RAR beta gamma agonist and NKT-cell modulators.

• Lead program GRI-0621 showed positive phase 2A results in idiopathic pulmonary fibrosis (IPF), meeting safety and tolerability endpoints and demonstrating robust biomarker improvements.

• Biomarker data indicated reduced fibrosis and signs of lung repair, with improved forced vital capacity (FVC) outcomes compared to standard of care.

• GRI-0621 exhibited a favorable safety profile, with fewer gastrointestinal side effects and no exacerbation of common adverse events seen in current therapies.

• GRI-0803, targeting regulatory T-cells, is advancing toward IND filing for systemic lupus erythematosus, with preclinical data showing reduced inflammation and improved kidney function.

Industry context and competitive differentiation

• Current IPF treatments slow lung function decline but do not halt or reverse disease; GRI-0621 showed potential for disease modification and epithelial repair.

• The safety and tolerability of GRI-0621 may enable combination therapies, aligning with industry trends toward multi-mechanism approaches.

• Biomarker and gene expression data from GRI-0621 align with preclinical models, supporting its differentiated mechanism and potential for broader application.

• The company is open to strategic partnerships for advancing to phase 2B and pivotal studies, seeking partners with complementary resources and expertise.

• IPF remains a high unmet need, with current drugs generating over $4 billion annually despite limited efficacy and tolerability.

Forward-looking statements and milestones

• Preparation for a phase 2B trial of GRI-0621 is underway, including drug manufacturing and feasibility work.

• IND-enabling studies for GRI-0803 are expected to conclude this year, with an IND filing planned to initiate a phase 1 trial in systemic lupus erythematosus.

• Early biomarker and clinical signals provide confidence for advancing to later-stage studies, with ongoing evaluation of combination strategies.

• The company is actively engaging in discussions with potential partners to support next-stage clinical development.

• Focus remains on addressing unmet needs in fibrotic and autoimmune diseases through innovative immune modulation.