Gri Bio, Inc. · NASDAQ:GRI
Gri Bio — Investor Presentation (August 2025)
23 slides from Gri Bio's investor presentation, Aug 20, 2025
Slide 1: A New Approach to Inflammatory Diseases
A New Approach to Inflammatory Diseases NASDAQ: GRI | gribio.com August 2025 Corporate Presentation Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer to buy any securities of GRI Bio, Inc. (“GRI” or the “Company”). This presentation contains “forward-looking statements” within the meaning of the “safe harbor” p
Slide 3: Highlights
Highlights Advancing an Innovative Pipeline of NKT Cell Modulators for the Treatment of Inflammatory, Fibrotic and Autoimmune Diseases Encouraging Preclinical Data Observed to Date on Par with OFEV® (nintedanib), a Leading Tyrosine Kinase Inhibitor with 2025 Projected Sales of $5 Billion3 3 1. Maher
Slide 4: Pipeline Targeting High-Value Indications in Need of Innovation
Programs Class Indication Preclinical Phase 1 Phase 2 Phase 3 Status GRI-0621 Reported Positive 2- & 6-Week Interim Data Completed Enrollment Topline Data Expected Q3 2025 GRI-0803 IND-Enabling and Phase 1 Program to Advance in 2026 GRI-NKT Multiple Pipeline Expansion Opportunities Pipeline Targetin
Slide 5: NKT Cells for Immune Regulation
NKT Cells for Immune Regulation 5 Novel Immune Mechanism to Regulate the Adaptive-Innate Immune Axis & Reset Dysfunctional Immune Responses Innate Immune System Adaptive Immune System T cells B cells dNKT iNKT Macrophages DC Eosinophil Basophil Neutrophil NK Crosstalk Adaptive ImmunityInnate Immunit
Slide 6: Targeting iNKT Cells Upstream of Key Fibrotic Targets
6 Targeting iNKT Cells Upstream of Key Fibrotic Targets iNKT is a key driver of propagating inflammatory/fibrosis cascade Downregulating iNKT provides potential for downstream benefits, including immune resolution and homeostasis Provides Potential Competitive Advantage (GRI-0621) Targeting Earlier
Slide 7: iNKT Cells: Top of the Inflammatory Cascade
7 iNKT Cells: Top of the Inflammatory Cascade Type 1 & 3 Immune Responses Key cytokines involved: TGF-β GM-CSF IL-17A Type 2 Immune Responses Key cytokines involved: IL-4 IL-5 IL-13 Repeated or prolonged injury drives a healing process towards chronic inflammation iNKT cells activate immune cells at
Slide 8: iNKT Cells Drive Disease Progression
iNKT Cells Drive Disease Progression 8 Biomarker May Support Recruitment Efforts, Treatment Efficacy and Identify Intent-to-Treat Populations in Clinical Studies IPF MASH Lupus
Slide 9: GRI-0621 Targets iNKT to Restore Homeostasis
9 GRI-0621 Targets iNKT to Restore Homeostasis Type 1 & 3 Immune Responses Type 2 Immune Responses GRI-0621 inhibits the activity of iNKT cells early in the inflammatory cascade to prevent cytokine release, cellular infiltration and interrupts disease progression at the source Resolution of chronic
Slide 10: GRI-0621 Idiopathic Pulmonary Fibrosis (IPF)
GRI-0621 Idiopathic Pulmonary Fibrosis (IPF) Phase 2a biomarker study enrollment completed with topline data expected Q3 2025 Reported positive data after 2- & 6-week interim analyses IDMC-reported no tolerability or safety concerns at interim analyses Leveraging FDA agreed 505(b)(2) regulatory path
Slide 11: The Need in Idiopathic Pulmonary Fibrosis
The Need in Idiopathic Pulmonary Fibrosis 11 A Rare Chronic Progressive Pulmonary Disease with Abnormal Scarring of the Lungs Blocking the Movement of Oxygen into the Bloodstream Significant side effects, limited compliance and no impact on survival3 Despite challenges, total 2022 sales were ~$4.3 b
Slide 12: GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis
12 GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis Established safety profile as an oral formulation GRI-0621 is an oral formulation of an FDA-approved topical dermatology product, tazarotene Prior late-stage studies of an oral formulation of tazarotene demonstrated favorable safety prof
Slide 13: GRI-0621 Outperforms Nintedanib in Treatment Model of IPF
GRI-0621 Outperforms Nintedanib in Treatment Model of IPF 13 ✓ GRI-0621 improves early inflammatory response as well as late fibrotic response ✓ GRI-0621, or combination with nintedanib, outperforms nintedanib alone in a standard preclinical bleomycin treatment model of IPF +10% or Better -10% or Wo
Slide 14: Ongoing Phase 2 Study in IPF
KEY INCLUSION CRITERIA 1. Men or women 40-85 yrs 2. Confirmed IPF diagnosis 3. FVC > 50% predicted 4. FEV1/FVC > 0.65 5. DLCOc > 30% predicted 6. Life expectancy of at least 12- months 7. Subjects on approved IPF therapy must remain on their current medication from Screening until the last study vis
Slide 15: GRI-0621 Treatment Shifted The Remodeling Rate Towards Fibrolysis
GRI-0621 Treatment Shifted The Remodeling Rate Towards Fibrolysis & Increased Biomarkers of Fibrosis Resolution Based on Interim Data 15 • Fibrosis is the accumulation of excess extracellular matrix comprised mainly of collagen • Serum biomarkers of collagen turnover can be measured to determine whe
Slide 16: GRI-0621-IPF-02 Biomarker Analysis
GRI-0621-IPF-02 Biomarker Analysis 16 Extensive biomarker analysis to build a robust Pharmacodynamic profile of GRI-0621 • Lung function tests in smaller studies less than 24 weeks have limited clinical significance on their own • Serum biomarkers can identify the rates of collagen synthesis and deg
Slide 17: Recent Acquisitions in IPF Suggest Potential for Significant Upside
Company Partner Stage (Year) Upfront Total Deal Phase 3 (2019) $3.95B $3.96B plus $1.1B investment undisclosed milestones Phase 2 (2019) $390M $1B milestones + royalties Phase 1 (2019) $50.57M $1.25B milestones Preclinical (2018) Preclinical (2020) $100M $20M R&D option agreement Upfront licensing f
Slide 18: GRI-0803 Initial Focus on Systemic Lupus Erythematosus (SLE)
GRI-0803 Initial Focus on Systemic Lupus Erythematosus (SLE) 18 Novel activator of human dNKT cells Extensive IP protection with issued composition of matter and use patents through 2032 and market LOE through 2037-2042* * Presumes future approval of maximum patent term extension and regulatory excl
Slide 19: The Need in Systemic Lupus Erythematosus
The Need in Systemic Lupus Erythematosus 1. https://www.cdc.gov/lupus/data-research/index.html 2. https://www.lupus.org/resources/what-is-systemic-lupus-erythematosus-sle 19 The most common form of lupus, SLE, is an autoimmune disease in which the immune system attacks its own tissue and organs DIAG
Slide 20: Pipeline Expansion Opportunities
Pipeline Expansion Opportunities 20 dNKT Agonists For Autoimmunity Potential Future Indications and Patient Populations (United States) 3M 1.5M 1.6M <200K <20K Multiple Sclerosis Rheumatoid Arthritis Inflammatory Bowel Disease Insulin Dependent Diabetes Mellitus Amyotrophic Lateral Sclerosis
Slide 21: Proven Leadership Team
Proven Leadership Team Marc Hertz, PhD Chief Executive Officer Vipin Kumar, PhD Prof. UCSD | CSO Albert Agro, PhD Chief Medical Officer 20+ years immunotherapy experience (fibrosis, inflammation, autoimmunity, allergy and oncology) Drug discovery through Phase 3 C-level & board positions at Pharmexa
Slide 22: Summary
Summary 22 Elevating Clinical Stage Biotechnology Company Advancing Innovative Pipeline Across Multiple Orphan and High-Value Inflammatory, Fibrotic and Autoimmune Diseases NKT Science Leading NKT regulation technology targeting earlier in the inflammatory cascade to interrupt disease progression Hi
Slide 23: Thank You!
A New Approach to Inflammatory Diseases NASDAQ: GRI | gribio.com Thank You! Investor Relations JTC Team 908-824-0775 gri@jtcir.com