Gri Bio, Inc. · NASDAQ:GRI
Gri Bio — Investor Presentation (April 2023)
22 slides from Gri Bio's investor presentation, Apr 27, 2023
Slide 1: Advancing Innovative NKT Cell Modulators to Transform the Treatment of Inflammatory, Fibrotic and Autoimmune Diseases
NASDAQ: GRI gribio.com Advancing Innovative NKT Cell Modulators to Transform the Treatment of Inflammatory, Fibrotic and Autoimmune Diseases Corporate Presentation April 2023 Exhibit 99.1
Slide 2: Forward Looking Statements
NASDAQ: GRI 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 "sa
Slide 3: GRI Bio at a Glance
NASDAQ: GRI GRI Bio at a Glance 3 NKT Science High-Value Indications Proven Team Leveraging Natural Killer T (NKT) regulation to target earlier in the inflammatory cascade to interrupt disease progression Lead program entering Phase 2 for Idiopathic Pulmonary Fibrosis (IPF); Second program commencin
Slide 4: Meet the GRI Leadership Team
NASDAQ: GRI Meet the GRI Leadership Team 4 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, & oncology) Drug discovery through Phase 3 C-level & board po
Slide 5: Development Pipeline Targeting High-Value Indications in Need of Innovation
NASDAQ: GRI Development Pipeline Targeting High-Value Indications in Need of Innovation 5 Programs Class Indication Pre-Clinic Phase 1 Phase 2 Phase 3 Status GRI-0621 Type 1 invariant NKT (iNKT) Antagonist Idiopathic Pulmonary Fibrosis (IPF) Launching Phase 2a in H2 2023 with topline interim data H1
Slide 6: NKT Cells for Immune Regulation
NASDAQ: GRI 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 Immu
Slide 7: Targeting iNKT Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage
NASDAQ: GRI Targeting iNKT Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage 7 NKT 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 ↓ NLRP
Slide 8: GRI-0621 Idiopathic Pulmonary Fibrosis (IPF)
GRI-0621 8 Idiopathic Pulmonary Fibrosis (IPF) 1. Sauleda J, Núñez B, Sala E, Soriano JB. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Basel). 2018 Nov 29;6(4):110. doi: 10.3390/medsci6040110. PMID: 30501130; PMCID: PMC6313500 Launching Phase 2a biomarker study
Slide 9: The Need in Idiopathic Pulmonary Fibrosis
NASDAQ: GRI The Need in Idiopathic Pulmonary Fibrosis 9 A rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream • Significant side-effects, limited compliance and no impact on survival1 • Despite challenges, total 2022 sale
Slide 10: GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
NASDAQ: GRI 10 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 profile in ~1,700 subjects iNKT inhibition demonstra
Slide 11: iNKT Cells Drive IPF Progression
NASDAQ: GRI iNKT Cells Drive IPF Progression 11 * * 20 15 10 5 0 HEALTHY IPF iNKT Healthy vs. IPF iN K T IF N 𝞬𝞬 Patients with IPF shown to have elevated levels of iNKT vs. Healthy Volunteers Bleomycin (BLM) Model * * * ***** 1.5 1.0 0.5 0.0 3 2 1 0 * **** C ol la ge n (% pe rib ro nc ho va sc ul…
Slide 12: Observed Reduction of TGF-β in Pulmonary Fibrosis Model
NASDAQ: GRI Observed Reduction of TGF-β in Pulmonary Fibrosis Model 12 ****** - WT - + WT - + KO - + WT + 0.0 0.5 1.0 1.5 2.0 2.5 BLM iNKT iNKT Inhibitor TG F- 𝜷𝜷 (n g/ m g) Reduced fibrosis Re-balanced inflammatory myeloid MØ (M1/M2) populations Improved survival TGF-β is the Central…
Slide 13: Planned Phase 2 Study in IPF
NASDAQ: GRI Planned Phase 2 Study in IPF 13 Screening Treatment Follow up Day ≤ -28 -4-weeks Day 1 to 84 12 weeks with planned interim analysis Day 98 2-weeks 2 arms: 4.5mg + placebo Patients: 36 IPF patients not on background IPF therapy Dosing: 4.5mg and placebo dosed orally 1x daily for 12 weeks
Slide 14: Recent Acquisitions in IPF Suggest Potential for Significant Upside
NASDAQ: GRI Recent Acquisitions in IPF Suggest Potential for Significant Upside 14 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 Preclinical (2020) $17M $360M + royalties Precl
Slide 15: Initial Focus on Systemic Lupus Erythematosus (SLE)
Initial Focus on Systemic Lupus Erythematosus (SLE) Target IND filing in H1 2024 with topline data from Phase 1a/b expected H2 2024 15 GRI-0803 Extensive IP protection with issued composition of matter and use patents and market LOE through 2038
Slide 16: The Need in Systemic Lupus Erythematosus
NASDAQ: GRI The Need in Systemic Lupus Erythematosus 16 The most common form of lupus, SLE is an autoimmune disease in which the immune system attacks its own tissue and organs AGE RANGE Commonly affects women of childbearing age1 15 - 44 PREVALENCE Confirmed as definite SLE1 ~160K DIAGNOSIS Number
Slide 17: Type 2 NKT Agonist Observed to Inhibit Lupus Nephritis in Model
NASDAQ: GRI Type 2 NKT Agonist Observed to Inhibit Lupus Nephritis in Model 17 Inflammation Decreased Interstitial Anatomy Improved Collagen deposition & fibrosis stopped Control Type 2 NKT Agonist Control (7/9) Type 2 NKT Agonist (10/10) The Most Common Manifestation of Lupus Nephritis & Re
Slide 18: Rapidly Advancing into the Clinic
Rapidly Advancing into the Clinic 18 Target IND Filing in H1 2024 with Topline Data Expected H2 2024 Steps toward IND Filing Validate bioanalytical methods Complete cGMP manufacturing Complete toxicology studies
Slide 19: Pipeline Expansion Opportunities: Type 2 NKT Agonists For Autoimmunity
NASDAQ: GRI Pipeline Expansion Opportunities Type 2 NKT Agonists For Autoimmunity 19 3M 1.5M 1.6M <200K <20K Multiple Sclerosis Rheumatoid Arthritis Inflammatory Bowel Disease Insulin Dependent Diabetes Mellitus Amyotrophic Lateral Sclerosis Potential Future Indications and Patient Populations (Unit
Slide 20: Multiple Potential Upcoming Value-Driving Milestones
NASDAQ: GRI Multiple Potential Upcoming Value-Driving Milestones 20 GRI-0621 GRI-0803 Corporate IND Filing Topline Results from Phase 1a/b Study 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 Enabl
Slide 21: Summary
NASDAQ: GRI Summary NKT Science High-Value Indications Proven Team Leading NKT regulation technology targeting earlier in the inflammatory cascade to interrupt disease progression Clinical pipeline in potential high- value indications with multiple pipeline expansion opportunities Team with proven N
Slide 22: Advancing Innovative NKT Cell Modulators to Transform the Treatment of Inflammatory, Fibrotic and Autoimmune Diseases
NASDAQ: GRI gribio.com Advancing Innovative NKT Cell Modulators to Transform the Treatment of Inflammatory, Fibrotic and Autoimmune Diseases Investor Relations: JTC Team 833.475.8247 gri@jtcir.com