GRI Bio (GRI) investor relations material

Innovative pipeline and mechanism of action

• Advancing immune modulators for inflammatory, fibrotic, and autoimmune diseases, focusing on idiopathic pulmonary fibrosis (IPF) and systemic lupus erythematosus (SLE).

• Oral RARβy agonist targets key immune cells early in the inflammatory cascade and activates lung repair mechanisms.

• Unique mechanism modulates immune activity upstream, impacting both early and late drivers of fibrosis.

• Pipeline includes GRI-0621 for IPF and a library of 500+ proprietary dNKT agonists for multiple indications.

Clinical data and trial outcomes

• GRI-0621 Phase 2a trial in IPF met primary and secondary endpoints, showing improved FVC, fibrosis resolution, and lung repair biomarkers with no safety issues.

• 95% of subjects experienced an FVC increase and 60% fewer had significant FVC decline after 12 weeks compared to standard of care.

• Biomarker analysis showed decreased type VI collagen synthesis, increased degradation, and repair of alveolar basement membrane.

• Immune profile shifted from type 2 pro-fibrotic to type 1 anti-fibrotic, with reductions in IL-4, IL-13, IL-17A, IL-22, and TGFβ1.

Market need and opportunity

• IPF is a rare, progressive lung disease with high mortality and limited treatment options; 50% die within 2-3 years of diagnosis.

• Only three approved drugs for IPF, with significant side effects and no impact on survival; 2022 sales reached ~$4.3 billion.

• SLE affects ~160,000 in the US, with only two drugs approved in the past 50 years; kidney nephritis is a key morbidity driver.