Gri Bio, Inc. · NASDAQ:GRI
Gri Bio — Investor Presentation (August 2023)
28 slides from Gri Bio's investor presentation, Aug 25, 2023
Slide 1: A New Approach to Inflammatory Diseases
A New Approach to Inflammatory Diseases NASDAQ: GRI | gribio.com August 2023 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: GRI Bio at a Glance
GRI Bio at a Glance Advancing an Innovative Pipeline of NKT Cell Modulators for the Treatment of High-Value Inflammatory, Fibrotic and Autoimmune Diseases NKT Science High-Value Indications Proven Team Lead program entering Phase 2 for Idiopathic Pulmonary Fibrosis (IPF); Second program commencing P
Slide 4: Meet the GRI Leadership Team
Meet the GRI 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 Ph
Slide 5: Development Pipeline Targeting High-Value Indications in Need of Innovation
Development Pipeline Targeting High-Value Indications in Need of Innovation Phase 2a Biomarker Study Type 1 invariant NKT (iNKT) Antagonist Idiopathic Pulmonary Fibrosis (IPF) Type 2 NKT Agonist Initial Focus: Systemic Lupus Erythematosus (SLE) Type 2 NKT Agonist Type 2 NKT Agonist Primary Sclerosin
Slide 6: NKT Cells for Immune Regulation
NKT Cells for Immune Regulation 6 Novel Immune Mechanism to Regulate the Adaptive-Innate Immune Axis & Reset Dysfunctional Immune Responses Innate Immune System Adaptive Immune System T cells B cells Type 2 NKT iNKT Macrophages DC Eosinophil Basophil Neutrophil NK Crosstalk Adaptive ImmunityInnate I
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 Healthy IPF N K T I I FN γ+ N K T I I FN γ+ IPF NASH Lupus Healthy SLEHealthy <F2 ≥F2 N K T I I FN γ+ C XC R 3+ Biomarker May Support Recruitment Efforts, Treatment Efficacy and Identify Intent-to-Treat Populations in Clinical Studies
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) Launching Phase 2a biomarker study with interim data expected H1 2024 and topline data H2 2024 Leveraging FDA agreed 505(b)(2) regulatory pathway Orphan indication with ~40K newly diagnosed cases annually1 10 1. Sauleda J, Núñez B, Sala E, Soriano JB. Idi
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: Modulation of NKT Activity Inhibits Inflammation and TGF-β
Modulation of NKT Activity Inhibits Inflammation and TGF-β 13 C el l N um be rs (1 06 /m L) in B AL F WBC Neutrophils Monocytes Lymphocytes TG F- β in B AL F (n g/ m g) Sham Vehicle GRI-0621 Nintedanib
Slide 14: Targeting iNKT Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage
Targeting iNKT Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage 14 IPF Animal Model: GRI-0621 significantly reduces inflammation, TGF-β, and fibrosis in a bleomycin model of pulmonary fibrosis and compares favorably to Nintedanib iNKT is a key driver of propagating inf
Slide 15: Planned Phase 2 Study in IPF
Planned Phase 2 Study in IPF 15 Screening Treatment Follow Up Day ≤ -28 -4 weeks Day 1 to 84 12 weeks with planned interim analysis Day 98 2 weeks 2 arms: 4.5 mg + placebo Enroll 36 Patients in Phase 2 IPF Trial Patients: 36 IPF patients on background IPF therapy Dosing: 4.5mg and placebo dosed oral
Slide 16: Recent Acquisitions in IPF Suggest Potential for Significant Upside
Recent Acquisitions in IPF Suggest Potential for Significant Upside 16 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 (2020)
Slide 17: GRI-0803 Initial Focus on Systemic Lupus Erythematosus (SLE)
GRI-0803 Initial Focus on Systemic Lupus Erythematosus (SLE) 17 Target IND filing in H1 2024 with topline data from Phase 1a/b expected H2 2024 Extensive IP protection with issued composition of matter and use patents and market LOE through 2038
Slide 18: The Need in Systemic Lupus Erythematosus
The Need in Systemic Lupus Erythematosus 18 The most common form of lupus, SLE, is an autoimmune disease in which the immune system attacks its own tissue and organs DIAGNOSIS Number of all lupus cases2 70% AGE RANGE Commonly affects women of childbearing age1 15 - 44 PREVALENCE Confirmed as definit
Slide 19: Type 2 NKT Agonist Observed to Inhibit Lupus Nephritis in Model
Type 2 NKT Agonist Observed to Inhibit Lupus Nephritis in Model 19 Control Type 2 NKT Agonist Control (7/9) Type 2 NKT Agonist (10/10) The Most Common Manifestation of Lupus Nephritis & Renal Damage, Proteinuria, Improved Improvement in Auto-Antibodies & Overall Survival Weeks Control Type 2 NKT
Slide 20: Rapidly Advancing into the Clinic
20 Rapidly Advancing into the Clinic Target IND Filing in H1 2024 with Topline Data Expected H2 2024 Validate bioanalytical methods Complete cGMP manufacturing Complete toxicology studies Steps Toward IND Filing
Slide 21: Pipeline Expansion Opportunities
Pipeline Expansion Opportunities 21 Type 2 NKT 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 22: Multiple Potential Upcoming Value-Driving Milestones
Multiple Potential Upcoming Value-Driving Milestones 22 FDA Clearance of IND and Start Phase 1a/b Completion of Merger Ongoing Evaluation of Pipeline Expansion Opportunities Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Completion of IND Enabling Studies Potential for Data Presentations at
Slide 23: Summary
Summary 23 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 24: Thank You!
A New Approach to Inflammatory Diseases NASDAQ: GRI | gribio.com Thank You! Investor Relations JTC Team 833-475-8247 gri@jtcir.com
Slide 25: Natural Killer T Cells
Natural Killer T Cells 25 T cells NK cells Neutrophil Epithelial Injury MØPro-fibrotic Cytokines NLRP3 Inflamma- some OPN & Hedgehog Myo- fibroblast iNKT Two Types: iNKT and Type 2 NKT Type 2 NKT iNKT TNFα IL-17A IL-6 LCN2 Proteinuria Cellular Infiltration Into Tissue Collagen Deposition & Fibrosis
Slide 26: Targeting iNKT Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage
Targeting iNKT Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage 26 iNKT is a key driver of propagating inflammatory/fibrosis cascade Downregulating iNKT provides potential for downstream benefits, including immune resolution and homeostasis IL-4/IL-5 NLRP3 Roche IL-13
Slide 27: iNKT: Mechanism of Action
27 Type 1 & 3 Immune Responses Type 2 Immune Responses iNKT: Mechanism of Action Tissue Injury ECM Deposition Neutrophil iNKT cell ILC2 Eosinophil CD4+ Th2 Macrophage FibroblastsFibroblasts Macrophage NET Myofibroblast CD4+ Th17IL-17A TGF-β1 NLRP3 Inflammasome IL-13 Alarmins IL-25 IL-33 TSLP IL-17A
Slide 28: Modulation of NKT Activity Results in the Inhibition of TGF-β
Modulation of NKT Activity Results in the Inhibition of TGF-β 28 Pulmonary FibrosisHepatic Fibrosis Renal Fibrosis *** *** 0.0 1.0 2.0 3.0 4.0 TG F- β (n g/ m g) 0.0 1.0 2.0 3.0 TG F- β m R N A Fo ld E xp re ss io n TG F- β in B AL F (n g/ m g)