Gri Bio, Inc. · NASDAQ:GRI
Gri Bio — Vallon Pharmaceuticals — Merger or Acquisition (December 2022)
24 slides from Gri Bio's merger presentation, Dec 13, 2022
Slide 1: Vallon Pharmaceuticals and GRI Bio Enter into Merger Agreement
vallon-pharma.com gribio.com Vallon Pharmaceuticals and GRI Bio Enter into Merger Agreement
Slide 2: Important Additional Information and Disclaimer
This presentation is for informational purposes only and has been prepared to assist interested parties in making their own evaluation with respect to the proposed merger between Vallon Pharmaceuticals Inc. (“Vallon”) and GRI, Bio, Inc. (“GRI”). The information contained herein does not purport to b
Slide 3: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking statements” within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplat
Slide 4: The Merger Agreement
The Merger Agreement 4 Merger expected to be completed 1Q 2023 At the closing, Vallon Pharmaceuticals is expected to change its name to GRI Bio, Inc. and, thereafter, trade on Nasdaq under the ticker symbol “GRI” Pre-closing financing round anticipated to be $14.75M with access to additional $10M Un
Slide 5: GRI Bio at a Glance
GRI Bio at a Glance 5 NKT Science High-Value Indications Proven Team Leveraging 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 commencing Phase 1a/1b, initially target
Slide 6: Meet the GRI Leadership Team
Meet the GRI Leadership Team 6 Marc Hertz, PhD Chief Executive Officer Vipin Kumar, PhD Prof. UCSD | CSO Albert Agro, PhD Chief Medical Officer 20+ years immunotherapy experience (liver, inflammation, autoimmunity, allergy, & oncology) Drug discovery through Phase 3 C-level & board positions at Phar
Slide 7: Development Pipeline
Development Pipeline Targeting High-Value Indications in Need of Innovation 7 Programs Class Indication Pre-Clinic Phase 1 Phase 2 Phase 3 Status GRI-0621 NKT I Antagonist Idiopathic Pulmonary Fibrosis (IPF) Launching Phase 2a in first half of 2023 with topline data expected Q2 2024 GRI-0803 NKT II
Slide 8: NKT Cells for Immune Regulation
NKT Cells for Immune Regulation 8 Novel Immune Mechanism to Regulate the Adaptive-Innate Immune Axis & Reset Dysfunctional Immune Responses Innate Immune System Adaptive Immune System T cells B cells NKT II NKT I Macrophages DC Eosinophil Basophil Neutrophil NK Crosstalk Adaptive ImmunityInnate Immu
Slide 9: Targeting NKT I Cells Upstream of Key Fibrotic Targets
Targeting NKT I Cells Upstream of Key Fibrotic Targets Provides Potential Competitive Advantage 9 NKT is a key driver of initiating inflammatory/fibrosis cascade Downregulating NKT provides potential for downstream benefits, including immune resolution and homeostasis NKT I ↓ IL-4/IL5 ↓ NLRP3 ↓ IL-1
Slide 10: GRI-0621 Idiopathic Pulmonary Fibrosis (IPF)
GRI-0621 10 Idiopathic Pulmonary Fibrosis (IPF) Launching Phase 2a biomarker study with data expected Q2 2024 Orphan indication with ~40K newly diagnosed cases annually1 1. Sauleda J, Núñez B, Sala E, Soriano JB. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Base
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 lung blocking the movement of oxygen into the bloodstream • Significant side-effects, limited compliance and no impact on survival1 • Despite challenges, total 2021 sales were ~$4
Slide 12: GRI-0621 for the Treatment of IPF
12 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 NKT I inhibition demonstrated fibrosi
Slide 13: NKT I Cells Drive IPF Progression
NKT I Cells Drive IPF Progression 13 * * 20 15 10 5 0 HEALTHY IPF NKT I Healthy vs. IPF N K T I I FN 𝞬𝞬 Patients with IPF shown to have elevated levels of NKT I 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 ar ar…
Slide 14: Observed Reduction of TGF-β in Pulmonary Fibrosis Model
Observed Reduction of TGF-β in Pulmonary Fibrosis Model 14 ****** - WT - + WT - + KO - + WT + 0.0 0.5 1.0 1.5 2.0 2.5 BLM NKT I NKT I 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 Mediator of…
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 42 6-weeks Day 56 2-weeks 4 arms: 1.5, 3.0, 4.5mg + placebo Patients: 35 IPF patients not on background IPF therapy Dosing: 1.5mg, 3.0mg, 4.5mg and placebo dosed orally 1x daily for 6 weeks Design: 4 arm RCT 2:
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 Preclinical (2020) $17M $360M + royalties Preclinical (2018
Slide 17: Initial Focus on Systemic Lupus Erythematosus (SLE)
Initial Focus on Systemic Lupus Erythematosus (SLE) Target IND filing in Q4 2023 with data from Phase 1a/b expected H1 2024 17 GRI-0803 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 AGE RANGE Commonly affects women of childbearing age1 15 - 44 PREVALENCE Confirmed as definite SLE1 ~160K DIAGNOSIS Number of all lupus
Slide 19: NKT II Agonist Observed to Inhibit Lupus Nephritis in Model
NKT II Agonist Observed to Inhibit Lupus Nephritis in Model 19 Inflammation Decreased Interstitial Anatomy Improved Collagen deposition & fibrosis stopped Control NKT II Agonist Control (7/9) NKT II Agonist (10/10) The Most Common Manifestation of Lupus Nephritis & Renal Damage, Proteinuria,
Slide 20: Rapidly Advancing into the Clinic
Rapidly Advancing into the Clinic 20 Target IND Filing in Q4 2023 with Data Expected H1 2024 Steps toward IND Filing Validate bioanalytical methods Complete cGMP manufacturing Complete toxicology studies
Slide 21: Pipeline Expansion Opportunities
Pipeline Expansion Opportunities NKT II Agonists For Autoimmunity 21 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 (United States)
Slide 22: Multiple Potential Upcoming Value-Driving Milestones
Multiple Potential Upcoming Value-Driving Milestones 22 GRI-0621 GRI-0803 Corporate Launch Phase 2a Biomarker Study Topline Results from Phase 2a Biomarker Study IND Filing Topline Results from Phase 1a/b Study Completion of Merger Evaluate pipeline expansion opportunities Ongoing Q1 2023 Q2 2023 Q3
Slide 23: Summary
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 NKT, immunolo
Slide 24: Vallon Pharmaceuticals and GRI Bio Enter into Merger Agreement
vallon-pharma.com gribio.com Vallon Pharmaceuticals and GRI Bio Enter into Merger Agreement
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