Gri Bio, Inc. · NASDAQ:GRI
Gri Bio — Investor Presentation (September 2026)
21 slides from Gri Bio's investor presentation, Sep 8, 2026
Slide 1: A New Approach to Inflammatory Diseases
A New Approach to Inflammatory Diseases NASDAQ: GRI | gribio.com CORPORATE PRESENTATION SEPT 2026 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation is being presented by GRI Bio, Inc. ("GRI" or the "Company") and 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 identifi
Slide 3: GRI-0621 in IPF: a safety-led wedge into a $6-9B market
GRI-0621 in IPF: a safety-led wedge into a $6-9B market 3 - NON CONFIDENTIAL - Adaptive Ph 2b/3 · orphan drug exclusivity + layered IP through late 2040s if new families grant $6-9B US branded IPF opportunity by 2035 AFT market growing 6-9% CAGR · US = 75% of branded revenue ~10% of US IPF patients
Slide 4: Program Pipeline: Targeting High-Value Indications
Program Pipeline: Targeting High-Value Indications Programs Class Indication Preclinical Phase 1 Phase 2 Phase 3 Status GRI-0621 RARβ/γ Agonist (oral tazarotene) Idiopathic Pulmonary Fibrosis (IPF) Positive Phase 2 across all endpoints Adaptive Pivotal study next step GRI-0803 dNKT Agonist Initial F
Slide 5: GRI-0621 (Oral Tazarotene) RARβ / RARγ Selective Agonist
5 GRI-0621 (Oral Tazarotene) RARβ / RARγ Selective Agonist Target Indication: Idiopathic Pulmonary Fibrosis (IPF) Positive Phase 2a data Addresses Unmet Needs Orphan Drug Designation Highlights - NON CONFIDENTIAL -
Slide 6: IPF landscape gaps and how the top programs address them
IPF landscape gaps and how the top programs address them 6 - NON CONFIDENTIAL - G A P 1 Cough & QoL IPF cough drives quality-of-life burden that SOC doesn't touch and Tyvaso worsens. GRI-0621 ✓0% treatment-related cough vs 25% PBO Nintedanib ●Neutral — no antitussive signal Pirfenidone ●Neutral — no
Slide 7: Concordant Signals Across Nine Mechanistic Pillars
Concordant Signals Across Nine Mechanistic Pillars Spanning Transcriptomic, Proteomic, Physiologic & Symptomatic Signals Unique Profile Observed ✓ Safe & Well Tolerated ✓ Immune Re-balancing ✓ Antifibrotic ✓ Lung Repair Signals ✓ FVC Preservation ✓ Antitussive ✓ GI-Protective 7 GRI-0621 (oral tazaro
Slide 8: GRI-0621-IPF-02: Study Design
GRI-0621-IPF-02: Study Design 8 Randomized, Double-Blind, Placebo-Controlled, 12-week Phase 2 Study GRI-0621 (tazarotene) 4.5 mg oral once daily DRUG & DOSE N=35 IPF patients 23 active : 12 placebo (2:1) POPULATION 80% on antifibrotic ~ 60% nintedanib ~ 20% pirfenidone BACKGROUND SOC 12-week treatme
Slide 9: GRI-0621-IPF-02: Study Treatment Related Adverse Events
GRI-0621-IPF-02: Study Treatment Related Adverse Events 9 GRI-0621-IPF-02 safety population (N=35) * Dry lips, dry skin, arthralgia and myalgia are retinoid class effects (Grade 1-2), transient, consistent with tazarotene safety database (>1,700 patients). Manageable with standard supportive care; n
Slide 10: GRI-0621 - Positive Shifts in Collagen Remodeling Rates Observed
GRI-0621 - Positive Shifts in Collagen Remodeling Rates Observed 10 Fibrillar collagen (III/VI) remodeling rates shifted towards net ECM degradation & fibrolysis Network-forming collagen (IV) remodeling rate shifted towards net synthesis & alveolar basement membrane repair Only Program in IPF to Sho
Slide 11: GRI-0621-IPF-02: FVC Responders vs Decliners
GRI-0621-IPF-02: FVC Responders vs Decliners 11 ~2-2.5x as Many Subjects in the Active Arm Experienced an FVC Increase (≥ 30mL) & Almost 2/3rds Fewer Experienced a Significant FVC Decline vs Placebo - NON CONFIDENTIAL - GRI-0621 INCREASED FVC FROM BASELINE GRI-0621 (all subjects) GRI-0621 (+SOC) Pla
Slide 12: GRI-0621-IPF-02: FVC Exploratory Endpoint
GRI-0621-IPF-02: FVC Exploratory Endpoint 12 Exploratory endpoint – study not powered for efficacy; 12-week placebo-adjusted change from baseline +99 mL Overall (ITT) GRI-0621 vs Placebo vs expected 3-40 mL decline +139 mL SOC Combination Subset (pre-specified exploratory) Strongest & most consisten
Slide 13: Cross-modality concordance across nine mechanistic pillars
Cross-modality concordance across nine mechanistic pillars 13 - NON CONFIDENTIAL - GRI-0621-IPF-02 Phase 2a, Week 12 · direction-consistent findings across four independent measurement modalities ↑ up-regulated ↓ down-regulated ⇅ directional shift Mechanistic pillar Spectral flow 28-color · BAL & PB
Slide 14: GRI-0621 in Combination
GRI-0621 in Combination 14 - NON CONFIDENTIAL - No pharmacokinetic conflict · orthogonal MOA · additive favorable FVC signal observed in the +SOC cohorts — across approved SOC, near-term launches, and every emerging Phase 3 mechanism CURRENT & NEAR-TERM BACKBONES Nintedanib Approved SOC · ~65% of tr
Slide 15: dNKT Agonists: GRI-0803 & 500+ compound library
15 dNKT Agonists GRI-0803 & 500+ compound library targeting innate-like immunoregulatory T cells GRI-0803 Target Phase 1 in 2027 SPMS or LN (SLE) Validate bioanalytical methods Complete cGMP manufacturing Complete toxicology studies Steps Toward IND Filing - NON CONFIDENTIAL -
Slide 16: Progressive MS: The Unmet Need
Progressive MS: The Unmet Need 16 Where current disease-modifying therapies fall short 0 DMTs for Non-Active SPMS No approved therapy for non-relapsing SPMS — the largest gap in MS ~16d Disability Postponed / Year Average benefit of ocrelizumab/siponimod in progressive MS; effect plateaus ~43% Non-A
Slide 17: Mechanism-to-outcome in EAE
Mechanism-to-outcome in EAE Source: Maricic et al., J Immunol 2014, Jahng et al., J Exp Med 2004 Activated in periphery and CNS Activated dNKT cells are present in both the peripheral immune compartment and the CNS of EAE models Expand MDSCs; tolerize microglia Activated dNKT increase myeloid-derive
Slide 18: Key Takeaways: dNKT Agonists in SLE
Key Takeaways: dNKT Agonists in SLE 18 NZBWF1 lupus model — selective, mechanism-driven activity Selective Not Broad Immunosuppression Inhibits iNKT, CD4, CD8 & B cells — but not neutrophils, eosinophils or monocytes ↓ LN Reduced Lupus Nephritis Lowers anti-DNA antibodies and TNF-α; blocks key signa
Slide 19: Intellectual Property & Regulatory Exclusivity
Intellectual Property & Regulatory Exclusivity 19 - NON CONFIDENTIAL - Portfolio by program · 6 patent families · 102 issued / 9 pending worldwide Program Patents Claim type Base expiry Follow-on / new filings Reg exclusivity add-on GRI-0621 3 US + 20 foreign issued Medical use 2032 + ODE 3 provisio
Slide 20: Market Opportunity
Market Opportunity 20 - NON CONFIDENTIAL - Market gap · mechanistic concordance · development timeline · exclusivity runway 1 · The market gap Large market · high discontinuation on approved AFT · big incremental TAM to capture 2035 US branded IPF opportunity $6-9B 6-9% CA GR · US = 75% of branded r
Slide 21: Thank You!
A New Approach to Inflammatory Diseases NASDAQ: GRI | gribio.com Thank You! Marc Hertz CEO 619-400-1170 mh@gribio.com Investor Relations JTC Team 833-475-8247 gri@jtcir.com