Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (July 2026)
59 slides from Inmune Bio's investor presentation, July 2026
Slide 1: Two Late-Stage Platforms Targeting Inflammation-Driven Disease
Two Late-Stage Platforms Targeting Inflammation- Driven Disease Corporate Presentation July 2026 NASDAQ: INMB 1
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by INmune Bio. Inc. (“INmune Bio” or the “Company”) solely for information purposes and does not constitute investment, legal, or medical advice. The Company makes no representation or warranty, express or implied, as to the accuracy, completeness, or t
Slide 3: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this presentation, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these te
Slide 4: Two Late-Stage Platforms Across Inflammation & Immunology
Two Late-Stage Platforms Across Inflammation & Immunology • Two Late - Stage Assets: Leading with CORDStrom (RDEB) and XPro1595 (Alzheimer’s), both entering regulatory/pivotal phases. • Near - Term Commercialization: CORDStrom targeting MAA filing (UK/EU) in Q3/Q4, 2026 and BLA (US) in late 2026.* •
Slide 5: Key Patents & Exclusivity Position
Key Patents & Exclusivity Position CORDStromTM XPro1595TM International PCT Stage International PCT Stage USPTO (ISA) USPTO (ISA) Favorable Written Favorable Written Opinion on Patentability Opinion on Patentability (all claims) (all claims) -CoM -CoM -Formulation -Formulation -MoT -MoT Nominal Pate
Slide 6: CORDStrom (Ebstrocel) for EB
CORDStrom ( Ebstrocel ) for EB Beyond Topical Care: Disease - Modifying Systemic Therapy 6
Slide 7: The Progressive Nature of Recessive Dystrophic EB (RDEB)
The Progressive Nature of Recessive Dystrophic EB (RDEB) 18 Months to 10 Years: The Critical Therapeutic Window 0-18 18 months-10 10-20 Over 20 Squamous cell months years years years carcinoma (SCC) 7
Slide 8: What Treatments do People Living with DEB Want Right Now?
What Treatments do People Living with DEB Want Right Now? Prioritisation survey 865 members EB global community 1. Pain relief 2024-Top 5 issues 2. Itch relief 3. Mental health children/YP 4. Impact of inflammation 5. GI issues e.g., dysphagia Source: FDA Patient-Focused Drug Development Meeting htt
Slide 9: Pruritus is a Clinically Meaningful Endpoint in RDEB
Pruritus is a Clinically Meaningful Endpoint in RDEB Evidence from Danial et al. (2015) and the PEBLES Prospective Registry (2023) Danial et al. (2015) PEBLES Registry (2023) • 146 EB patients • 50 RDEB patients • Itch ranked the most bothersome complication • 243 longitudinal assessments over 7 yea
Slide 10: The Itch-Scratch-Wound-Inflammation Cycle in RDEB
The Itch-Scratch-Wound-Inflammation Cycle in RDEB A self-perpetuating cycle that drives diseases disease burden 10
Slide 11: Why Reducing Pruritus May Reduce Wounds and Long-Term SCC Risk in RDEB
Why Reducing Puritus May Reduce Wounds and Long-Term SCC Risk in RDEB Inflammation New & Chronic Pruritus Persistent & Healing Scratching Recurrent Non-healing ↑ SCC Risk (Itch) Inflammation Wounds Wounds Wounds Evidence Implications • Scratching tears fragile skin, enlarges wounds and creates • Chr
Slide 12: Mission EB Phase III: Randomized, Placebo-Controlled Crossover Trial
Mission EB Phase III: Randomized, Placebo-Controlled Crossover Trial 2012 - Cure EB Charity funded EBSTEM an open label study 10 children with RDEB from Great Ormond Street treated with 3 infusions of bone derived stem cells with promising results lasting up to 6 months 2019 – NIHR / NHS England / C
Slide 13: Mission EB Clinical Trial Summary
Mission EB Clinical Trial Summary Month-3 Data Month-6 Data • RDEB-Severe patients across all ages • Itch reduction maintained 6 months post cell infusions across all of the itch-man (9/30) scale cohort • No improvement in their skin scores • The largest itch reduction was seen in the • 25% reductio
Slide 14: Conclusion From Month 6 Data
Conclusion From Month 6 Data • There is large improvement in all iscorEB scores in RDEB-S cohort not seen at month-3 • The observed skin improvement and wound closure is likely to be disease modifying, improving pain and quality of life and reduce the long-term risk of squamous cell carcinoma 14
Slide 15: Qualitative Results
Qualitative Results • 13 participants (reporting on 9 cases) • 8 parents • 5 children • Completed blinded interview at two time points • 3 months post UC-MSCs • 3 months post placebo • 12/13 reported benefits on Ebstrocel • 3/13 reported benefits on placebo • 2 post Ebstrocel • 1 treatment naive • 1
Slide 16: Comprehensive Organ System Improvements
Comprehensive Organ System Improvements Itch Man "I don't sleep because of the itch. CS switches 2/3 of pts with grade 3 to grade 2 I just wait for the sun to come up." 1/4 of pts on placebo who were grade 2 Level 2: Itches more; sometimes interferes progress to grade 3 with activity "The itch is ju
Slide 17: Comprehensive Organ System Improvements
Comprehensive Organ System Improvements ISCOREB Improvement Scores Period 1 at 3 and 6 months Ebstrocel is potentially the first systemic therapy with itch and pain relief benefits as key differentiation factors in quality of life. Pain indicies 20 Gastrointestinal symptoms Wellbeing CS 3m 20 30 Pla
Slide 18: Overall Summary
Overall Summary • Ebstrocel has proven to be beneficial treatment with no safety signals in children with RDEB from the age of 6 months • Intermediate and younger patients under the age of 10 years saw earlier effects with improvement of their skin, pain and itch • Although the most severe and older
Slide 19: Standards for Conditional Drug Approval
Standards for Conditional Drug Approval • Core Efficacy Requirements (MHRA, EMA & Similar Frameworks) • Positive Benefit-Risk Balance: Data must indicate that the drug's benefits outweigh its risks, even if the data are less comprehensive than required for standard marketing authorisation. • Proof o
Slide 20: Ebstrocel – Complex Mechanisms of Action Validated
Ebstrocel – Complex Mechanisms of Action Validated 20
Slide 21: Ebstrocel Mechanisms of Action - Details
Ebstrocel Mechanisms of Action - Details M1 to M2 differentiation in vitro Monocyte differentiation in vitro 1000000 80000 CD14 60000 CD73 MedFI (AU) CD86 500000 40000 CD80 Th2 CD163 Th17 HLA-DR 20000 TNF-a IL-6 0 0 M0 M1 control M1 Ebstrocel s/n M2 control M1 Ebstrocel P = 0.1531 IL-10 concentratio
Slide 22: Ebstrocel Mechanisms of Action: Proof of MoA in vivo
Ebstrocel Mechanisms of Action Proof of MoA in vivo TNF-a In vivo ISCOREB Gastrointestinal symptoms 20 Itch & Pain 3 months REDUCTION Th2 50 Th17 10 40 Delta preRx TNF-a IL-6 Improvement Score 0 30 20 -10 10 -20 M1 Placebo CPD <20 CPD >20 Ebstrocel 0 Eating Bowel PGE2 Site 20 IL-13 in vivo IDO IL-8
Slide 23: Why Historical MSC Development Failed: The Problem of Heterogeneity
Why Historical MSC Development Failed: The Problem of Heterogeneity The Heterogeneity issue The Consequence Inconsistent Identity: Donor Variation: Clinically Naive Lots of subsets (with unknown potency or MOA. High heterogeneity from donor - to- donor Assumptions. and source - to- source (Bone marr
Slide 24: The CORDStrom Solution: Engineered Homogeneity Through Identity Selection and Pooling
The CORDStrom Solution: Engineered Homogeneity Through Identity Selection and Pooling Minimum Proprietary High Potency 4 “ selected” UC Donors High Reproducibility Pooling Process Master Cell Stock Source Identity Advantage Umbilical Cord Tissues Characterized by standard markers Pooling minimizes d
Slide 25: Commercial-scale manufacture complete and future-proofed
Commercial-scale manufacture complete and future-proofed Available = 80L Supply Reliability ~100 patients in UK 4 doses/year 45 years from same 4xdonor In development = 15L stock Current scale = 3L 1. Phase-dependent, scalable DP 34,000 WCS /WCS 1000 /PSS PSS 25/donor 2. Closed Bioprocessing Closed
Slide 26: Ebstrocel for RDEB: Path To Market
Ebstrocel for RDEB: Path To Market Complete technology RPDD approved transfer to commercial Submit MAA to MHRA EMA by FDA manufacture (Catapult UK) Conditional Approval F-2-F pre MAA PIP meeting MHRA ODD approved Submit BLA to FDA by FDA response MHRA Conditional approval Dec 2024 Jan 2025 Dec 2025
Slide 27: Phase 3 Open Label Trial – 18 Months MISSION EB-DELIVER
Phase 3 Open Label Trial – 18 Months MISSION EB-DELIVER 10
Slide 28: Market Landscape: Comparison of Therapeutic Approaches
Market Landscape: Comparison of Therapeutic Approaches Vyjuvek = Product of Krystal Biotech, Inc.; Filsuvez = Product of Chiesi Farmaceutici S.p.A.; Zevaskyn = Product of Abeona Therapeutics Inc. 28 The TAM is an estimate based on internal assumptions and third-party sources, is a forward-looking st
Slide 29: Parent Quotes
Parent Quotes When she has been getting ill she has just been recovering in the same time as her brother, normally illness affects her much more because it causes inflammation. We have just been able to cope with everything so much better and have lots of energy and I suppose life has felt normal I
Slide 30: Children's Quotes
Children’s Quotes It was less painful, when I itch it’s painful so obviously that’s not comfortable, but I had less pain, my skin was less itchy, my hands were less hot and when they are hot I itch. That was not happening that much. Normally it would hurt when I have a bath but lately it hasn’t been
Slide 31: CORDStrom RDEB Summary
CORDStrom RDEB Summary MISSION EB Team Quote from a parent: 2024 “If it makes only one per cent difference, then I’m happy to come whenever they call us for the trial because that one per cent isn’t a lot I know, maybe it’s nothing for somebody, but it’s a lot for him, one per cent less pain for him
Slide 32: Approaching Alzheimer's as an Immunologic Disease
Approaching Alzheimer’s as an Immunologic Disease 32
Slide 33: XPro1595 (XPro): Neutralize TNF while Preserving Immune Function
XPro1595 (XPro): Neutralize TNF while Preserving Immune Function XPro1595 is identical to the human soluble TNF monomer with the exception of mutations in the receptor binding domain and another for pegylation. Dominant-Negative in genetics: "A mutation producing a rogue protein that interferes with
Slide 34: Normal Soluble TNF activity
Normal Soluble TNF activity solTNF monomers form active heterotrimers that bind to TNF receptor. Each monomer in the trimer contacts one TNFR subunit 34
Slide 35: XPro1595 MOA
XPro1595 MOA Xpro7595treely exchanges with solINF monomers = tmTNF homotrimers are anchored to the cell to form inactive heterotrimers membrane, XPro/595 cannot exchange Inflammatory soluble TNF eliminated: No paracrine signaling through receptors a & XProtg9§ solr (recombinant or physiological) Imm
Slide 36: XPro1595 is Neuroprotective
XPro1595 is Neuroprotective Normal Cuprizone Etanercept XPro1595 (Model of Multiple Sclerosis) Anti-inflammatory AND Anti-inflammatory NOT immunosuppressive immunosuppressive Exacerbated demyelination Remyelination Adapted from: Karamita et al., 2017 36
Slide 37: XPro1595 Peer-Reviewed Publications: Breadth of Scientific Validation
XPro1595 Peer-Reviewed Publications: Breadth of Scientific Validation More Than A Decade of Research Excellence XPro1595's therapeutic potential has been rigorously validated across more than 90 peer-reviewed publications spanning 24 therapeutic areas, 2 dozen independent laboratories, and 3 contine
Slide 38: Cytokines are not informative biomarkers of chronic inflammation
Cytokines are not informative biomarkers of chronic inflammation (Immune Dysfunction) Adapted from PMID: 27994591 and 18673219 38
Slide 39: Strong Evidence for anti-TNF to Treat Alzheimer's Disease
Strong Evidence for anti-TNF to Treat Alzheimer’s Disease Evidence linking TNF to AD TNF increases TNF levels increase beginning the 3rd or 4th with Age decade of life and correlate with age6 TNF increased in Plasma and CSF TNF levels increased in AD AD Patients patients2,3 TNF co-localizes with amy
Slide 40: Biomarker Enrichment Rationale
Biomarker Enrichment Rationale Matching drug biology to patient · Predictive enrichment using downstream indicators of TNF-driven biology Enrichment is predictive — identifying patients with TNF-driven disease biology most likely to benefit from XPro1595. hypothesis-driven precision medicine. ADi =
Slide 41: Phase 2: Why Did We Miss P-Value in Cognition (EMACC)?
Phase 2: Why Did We Miss P-Value in Cognition (EMACC)? No Placebo Decline in mITT To assess a possible treatment effect of XPro1595 Original Key Inclusion Criteria: Enriched Protocol compared to placebo, a decrease in cognition within the placebo-treated group over the study period is • Age (60 - 85
Slide 42: Phase 2: Consistent Signal in AD Inflammation Enriched Population
Phase 2: Consistent Signal in AD Inflammation Enriched Population 6-month RCT · N = 206 (mITT: XPro n=139, placebo n=67) · ADi enrichment: ≥2 of 4 biomarkers AND amyloid positive (n=100) Key Findings: ADi Enriched Population Overall Population (mITT) Endpoint Effect Size Signal 72 yrs median age · 5
Slide 43: Differentiated Safety Profile
Differentiated Safety Profile No ARIA · Immune Function Preserved · SAEs Lower on Drug 0 ARIA Events Placebo infection rates 2× higher Despite a high-risk population: XPro1595 preserves systemic immune function 68.5% APOE4+ · 34% with microbleeds — selectively inhibiting inflammatory TNF (sTNF) 27%
Slide 44: Phase 2b/3 Adaptive Trial Design — FDA Aligned
Phase 2b/3 Adaptive Trial Design — FDA Aligned FDA End-of-Phase 2 Meeting Completed Q1 2026; Fast Track Granted Q2 2026 FDA Alignment Enrichment Design Endpoint Exploratory ADi biomarker strategy endorsed Adaptive 2b/3 with decision CDR-SB as sole Phase 3 primary Non-enriched cohort gate accepted re
Slide 45: CDR-SB Confidence: Why 18 Months Will Work
CDR-SB Confidence: Why 18 Months Will Work EMACC detects subtle cognitive changes- CDR-SB measures the consequences. Phase 2b: 3 more months + 3× sample Anti-amyloid precedent: CDR-SB We have the early signal. → more time for placebo decline separation emerged at 18 months Now we need the time. The
Slide 46: Why CDR-SB Requires More Time: Evidence from External AD Cohorts
Why CDR-SB Requires More Time: Evidence from External AD Cohorts Enough Cognitive Change Must Occur to Measure Functional Change EMACC captures subtle cognitive change early — the leading indicator. CDR-SB captures cognitive and functional consequences later – lagging indicator and registrational en
Slide 47: XPro1595 Path to Execution
XPro1595 Path to Execution o Staged Investment: The Phase 2b/3 design stages the capital commitment. The Phase 2b serves as a de-risking milestone with a built-in go/no-go decision before full Phase 3 expenditure. o Capital Markets: As catalysts mature across our pipeline, including CORDStrom, we ex
Slide 48: Thank You!
Thank You! INmune Bio Inc. 225 NE Mizner Blvd. Ste. 640 Boca Raton, FL 33432 +1 561 710 0512 info@inmunebio.com Investor Relations: Daniel Carlson +1 415 509 4590 dcarlson@inmunebio.com INMB (Nasdaq) 48
Slide 49: Appendix
Appendix 49
Slide 50: Phase 1: 0 to 18 months
Phase 1: 0 to 18 months • Cutis aplasia-months to heal • Wounds heal • Weight gain satisfactory • Relatively stable period
Slide 51: Phase 2: 18 months to 10 years
Phase 2: 18 months to 10 years • Wound burden & skin colonization advances • Wounds heal within 21 days • They are recurrent & reoccurring wounds but not chronic • First signs of internal involvement • inflammatory markers elevated • weight faltering • the onset of anemia • first signs of esophageal
Slide 52: Phase 1 and 2
Phase 1 and 2 • Window of opportunity for anti-inflammatory therapy such as CORDStrom for systemic disease pathology Therapeutic Requirements: Anti-inflammatory cytokines Reprogramming pro-inflammatory macrophages (M1) to anti-inflammatory (M2)
Slide 53: Phase 3: 10 to 20 years
Phase 3: 10 to 20 years • Skin involvement continues to increase • chronic wounds over 21 days • bacterial colonisation • multiple co morbidities • Dramatic reduction in the ability to heal Therapeutic Requirements: Wound healing cytokines Increased innate immune activity against bacteria/fungi
Slide 54: Phase 3: 10 to 20 years
Phase 3: 10 to 20 years • Massive levels of chronic inflammation • affects 4 major pathways Therapeutic Requirements: Wound healing cytokines Increased innate immune activity against bacteria/fungi
Slide 55: Phase 4: From 20 years onwards
Phase 4: From 20 years onwards • Steady progression of the severity • Chronic wounds very rarely heal Therapeutic Requirements: Symptom control
Slide 56: Phase 4: From 20 years onwards
Phase 4: From 20 years onwards • Patients are at high risk for developing squamous cell carcinoma, a life- threatening complication of severe RDEB • Tumors are usually well differentiated and rapidly-growing, often on the extremities with a median survival of 2.4 years for this EB subtype • Anti-inf
Slide 57: Capturing Stability: from Minutes to Lifelong Predisposition
Capturing Stability: from Minutes to Lifelong Predisposition Xu et al., 2020; Resi et al., 2021 57
Slide 58: Mechanistic Links Between TNF and Downstream Biomarkers
Mechanistic Links Between TNF and Downstream Biomarkers Macrophage Amplifies TNF Production Argi12 Arg158 Astrocyte Microglial cell Genetic variants Arg112/Arg158 trigger lifelong glial inflammation, increasing TNF production in microglia and astrocytes. Ike IL-6R/| gp130 Inflammatory cell Hepatocyt
Slide 59: The "≥2 of 4" Composite Design: High-Confidence Identification of a TNF-Driven Phenotype
The "≥2 of 4" Composite Design: High-Confidence Identification of a TNF-Driven Phenotype Requiring positivity on at least two independent biomarkers substantially increases specificity for TNF-driven biology and reduces misclassification arising from single-marker noise or non-TNF-related inflammato