Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (October 2026)
53 slides from Inmune Bio's investor presentation, Oct 21, 2026
Slide 1: Two Late-Stage Platforms Targeting Inflammation-Driven Disease
Two Late-Stage Platforms Targeting Inflammation- Driven Disease Corporate Presentation October 2026 NASDAQ: INMB
Slide 2: Disclaimer
2 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
Slide 3: Forward-Looking Statements
3 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
Slide 4: Two Late-Stage Platforms Across Inflammation & Immunology
4 Two Late-Stage Platforms Across Inflammation & Immunology Ebstrocel / CORDStrom RDEB regulatory submissions UK pre-MAA package submitted Full UK MAA targeted for February 2027 Potential UK approval in mid-2027 U.S. BLA planned for Q2 2027, subject to FDA feedback. Uniphar agreement supports planne
Slide 5: Key Patents & Exclusivity Position
5 Key Patents & Exclusivity Position CORDStromTM XPro1595TM International PCT Stage USPTO (ISA) Favorable Written Opinion on Patentability (all claims) -CoM -Formulation -MoT Nominal Patent Coverage thru 2045 Eligible for PTE up to +5years on approval International PCT Stage USPTO (ISA) Favorable Wr
Slide 6: CORDStrom (Ebstrocel) for EB: Beyond Topical Care
6 for EB CORDStrom ( Ebstrocel ) Beyond Topical Care: Disease - Modifying Systemic Therapy
Slide 7: CORDStrom – a Mesenchymal Stromal Cell (MSC) Platform
7 CORDStrom – a Mesenchymal Stromal Cell (MSC) Platform What is CORDStrom ? Mechanisms Of Action • Pooled, allogeneic donor, umbilical cord - derived Mesenchymal Stromal/Stem Cell (MSC) product (minimum four donors) • Suppression of inflammation: RDEB /EB, OA, trauma, etc • Highly reproducible, off
Slide 8: Why Historical MSC Development Failed: The Problem of Heterogeneity
8 Why Historical MSC Development Failed: The Problem of Heterogeneity – AND THE SOLUTION Cell Population Doubling reduces potency over time. The assumption that "all MSCs are the same" led to few approvals. Past failures were not due to a lack of therapeutic potential, but a lack of product consiste
Slide 9: Recessive Dystrophic EB
Recessive Dystrophic EB
Slide 10: Multisystemic disease RDEB-SG
Multisystemic disease RDEB-SG
Slide 11: The Progressive Nature of RDEB
11 0-18 months 18 months-10 years 10-20 years Over 20 years Squamous cell carcinoma (SCC) The Progressive Nature of Recessive Dystrophic EB (RDEB) 18 Months to 10 Years: The Critical Therapeutic Window
Slide 12: What Treatments Do People Living with DEB Want Right Now?
12 1. Pain relief 2. Itch relief 3. Mental health children/YP 4. Impact of inflammation 5. GI issues e.g., dysphagia Prioritisation survey 865 members EB global community 2024-Top 5 issues What Treatments do People Living with DEB Want Right Now? Source: FDA Patient-Focused Drug Development Meeting
Slide 13: Pruritus is a Clinically Meaningful Endpoint in RDEB
13 Pruritus is a Clinically Meaningful Endpoint in RDEB Evidence from Danial et al. (2015) and the PEBLES Prospective Registry (2023) Danial et al. (2015) • 146 EB patients • Itch ranked the most bothersome complication • Healing wounds produced greatest itch • Major impact on sleep and quality of l
Slide 14: The Itch-Scratch-Wound-Inflammation Cycle in RDEB
14 The Itch-Scratch-Wound-Inflammation Cycle in RDEB A self-perpetuating cycle that drives diseases disease burden
Slide 15: Why Reducing Pruritus May Reduce Wounds and SCC Risk
15 Why Reducing Pruritus May Reduce Wounds and Long-Term SCC Risk in RDEB Inflammation & Healing Wounds Pruritus (Itch) Scratching New & Recurrent Wounds Chronic Non-healing Wounds Persistent Inflammation ↑ SCC Risk Evidence • Scratching tears fragile skin, enlarges wounds and creates new blisters.
Slide 16: Mission EB Phase II: Randomized, Placebo-Controlled Crossover Trial
16 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
Slide 17: Mission EB Clinical Trial Summary
17 Mission EB Clinical Trial Summary Month-3 Data • RDEB-Severe patients across all ages (9/30) • No improvement in their skin scores • 25% reduction in ITCH Month-6 Data • Itch reduction maintained 6 months post cell infusions across all of the itch-man scale cohort • The largest itch reduction was
Slide 18: Conclusion
18 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
Slide 19: Qualitative Results
19 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
Slide 20: Comprehensive Organ System Improvements; Itch Man Scale
20 Comprehensive Organ System Improvements; Itch Man Scale Severity level 2 - Pre Severity level 3 - Pre Severity level 2 - Post Severity level 3 - Post Severity level 2 - Pre Severity level 3 - Pre Severity level 2 - Post Severity level 3 - Post 0 10 20 30 40 Itch Man Categorical mITT Patients affe
Slide 21: Comprehensive Organ System Improvements; ISCOREB Scores
21 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. Skin Mouth Eye Joint -5 0 5 10 15 20 Pain indicies Site CS 3m Pl
Slide 22: Overall Summary
22 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 ol
Slide 23: Uniphar: International Access and Commercialization Agreement
23 Uniphar: International Access and Commercialization Agreement signed with Uniphar Durbin Ireland Limited A scalable framework for international access, distribution and future commercialization of Ebstrocel. Initial access markets Selected European countries and the Middle East and North Africa (
Slide 24: Ebstrocel – Complex Mechanisms of Action
24 Ebstrocel – Complex Mechanisms of Action Validated Complex Mechanism of Systemic Resolution: M1 to M2 Shift
Slide 25: Ebstrocel Mechanisms of Action - Details
25 Ebstrocel Mechanisms of Action - Details M1 to M2 differentiation in vitro M0 M1 control M1 Ebstrocel s/n M2 control 0 500000 1000000 0 20000 40000 60000 80000 MedFI (AU) CD14 CD73 CD163 CD86 CD80 HLA-DR Monocyte differentiation in vitro M1 Ebstrocel M2 PGE2 ENHANCED WOUND HEALING IL-13 TGF-b / V
Slide 26: Ebstrocel Mechanisms of Action: Proof of MoA in vivo
26 Ebstrocel Mechanisms of Action Proof of MoA in vivo Placebo CPD <20 CPD >20 -20 -10 0 10 20 TNF-a In vivo Delta preRx Placebo CPD <20 CPD >20 -200 -100 0 100 200 HGF Delta preRx Placebo CPD <20 CPD >20 -20 -10 0 10 20 IL-13 in vivo Delta preRx 3D NUC-05 3D NUC-07 3D NUC-08 3D UCT-IN-11 3D WPS-1 3
Slide 27: Why Historical MSC Development Failed: The Solutions to Heterogeneity
27 Why Historical MSC Development Failed: The Solutions to Heterogeneity Cell Population Doubling changes potency over time. Senescence: High heterogeneity from donor - to- donor and source - to- source (Bone marrow vs. Adipose vs UC). Donor Variation: Lots of subsets (with unknown potency or MOA. I
Slide 28: The CORDStrom Solution: Engineered Homogeneity Through Pooling
28 The CORDStrom Solution: Engineered Homogeneity Through Identity Selection and Pooling Pooling minimizes donor variation, creates a highly reproducible product, and enables massive scalability. Advantage Characterized by standard markers (CD73/90/105) PLUS potency - specific markers (CD10, CD29, C
Slide 29: Commercial-scale manufacture complete and future-proofed
29 Commercial-scale manufacture complete and future-proofed 1. Phase-dependent, scalable 2. Closed Bioprocessing PSS 25/donor WCS 1000 /PSS DP 34,000 /WCS ~100 patients in UK 4 doses/year 45 years from same 4xdonor stock Current scale = 3L Closed from MCB to Final Drug Product 0.5L to 80L 0.2L to 20
Slide 30: Ebstrocel: Updated Regulatory Milestones
Ebstrocel : Updated Regulatory Milestones 30 Completed Pre-MAA package submitted to MHRA February 2027 Full UK MAA targeted after MHRA feedback Mid-2027 Potential UK approval following agency review Q2 2027 U.S. BLA planned, subject to Type B meeting feedback European Union EMA filing prioritized af
Slide 31: Conditional / Accelerated Approvals – Safety and Preliminary Efficacy Data
31 Conditional / Accelerated Approvals – safety and PRELIMINARY Efficacy data MHRA / EMA / FDA MISSION EB Phase II trial - endpoints Primary Safety - MET Change in EBDASI total score at 3 months – FAILED Secondary Improvement in Total iscorEB – MET (Intermediate Group) Improvement in Pain (FACES sco
Slide 32: Ebstrocel: Regulatory Priorities
32 Ebstrocel : Regulatory Priorities UK: complete application replaces rolling submission Faster CMC progress supports a full MAA in early February 2027. The revised plan could advance potential UK approval by approximately six weeks. U.S.: FDA application ahead of EMA Rare disease regulatory adviso
Slide 33: Phase Open Label Trial – MISSION EB-DELIVER
Phase 3 Open Label Trial – 18 Months 33 10 MISSION EB-DELIVER
Slide 34: 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. 34 The TAM is an estimate based on internal assumptions and third-party sources, is a forward-looking st
Slide 35: Parent Quotes
35 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
Slide 36: Children's Quotes
36 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 b
Slide 37: CORDStrom RDEB Summary
37 CORDStrom RDEB Summary Quote from a parent: "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 is one per cent m
Slide 38: Approaching Alzheimer's as an Immunologic Disease
38 Approaching Alzheimer's as an Immunologic Disease
Slide 39: XPro1595: Neutralize TNF while Preserving Immune Function
39 XPro1595 (XPro): Neutralize TNF while Preserving Immune Function see Steed et al., Science, 301, 2003 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 produc
Slide 40: Normal Soluble TNF activity
40 Normal Soluble TNF activity solTNF monomers form active heterotrimers that bind to TNF receptor. Each monomer in the trimer contacts one TNFR subunit
Slide 41: XPro1595 MOA
XPro1595 MOA Xpro7595treely exchanges with solTNF monomers to form inactive heterotrimers Inflammatory soluble TNF eliminated: No paracrine signaling through receptors a2 & XProt595 solr (recombinant or physiological) Exchange = No paracrine signaling tmTNF homotrimers are anchored to the cell membr
Slide 42: XPro1595 is Neuroprotective
42 XPro1595 is Neuroprotective Normal Etanercept Anti-inflammatory AND immunosuppressive Cuprizone (Model of Multiple Sclerosis) Exacerbated demyelination XPro1595 Anti-inflammatory NOT immunosuppressive Remyelination Adapted from: Karamita et al., 2017
Slide 43: 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 44: Cytokines are not informative biomarkers of chronic inflammation
44 Cytokines are not informative biomarkers of chronic inflammation (Immune Dysfunction) Adapted from PMID: 27994591 and 18673219
Slide 45: Strong Evidence for anti-TNF to Treat Alzheimer's Disease
45 Strong Evidence for anti-TNF to Treat Alzheimer's Disease 1. Torres-Acosta N, et al. J Alzheimer's Dis. 2020;78:619–626 2. Fillit H, et al. Neurosci Letters. 1991;129:318-320 3. Tarkowski E, et al. J Clin Immunol. 1999, 19(4):223-230 4. Dickson DW. J Neuropathol Exp. Neurol 1997;56:321-339 5. Pag
Slide 46: Biomarker Enrichment Rationale
46 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 47: Phase 2: Why Did We Miss P-Value in Cognition (EMACC)?
47 Phase 2: Why Did We Miss P-Value in Cognition (EMACC)? No Placebo Decline in mITT Original Key Inclusion Criteria: Enriched Protocol • Age (60 - 85 years) • Diagnosis of mild AD (NIA-AA stage-4)1 • Amyloid-beta positive (Aβ+) • MMSE ≥ 22 • ≥ 2 blood biomarkers of inflammation Expanded Inclusion C
Slide 48: Phase 2: Consistent Signal in AD Inflammation Enriched Population
48 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) Overall Population (mITT) 72 yrs median age · 51% female · 45% MCI 68.5% APOE4 carriers — highest ARIA risk po
Slide 49: Differentiated Safety Profile
49 Differentiated Safety Profile No ARIA · Immune Function Preserved · SAEs Lower on Drug 0 ARIA Events Despite a high-risk population: 68.5% APOE4+ · 34% with microbleeds 27% on antithrombotic Placebo infection rates 2× higher XPro1595 preserves systemic immune function — selectively inhibiting inf
Slide 50: Phase 2b/3 Adaptive Trial Design — FDA Aligned
50 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 ADi biomarker strategy endorsed Design Adaptive 2b/3 with decision gate accepted Endpoint CDR-SB as sole Phase 3 primary Exploratory Non-enriched cohort
Slide 51: CDR-SB Confidence: Why 18 Months Will Work
51 CDR-SB Confidence: Why 18 Months Will Work EMACC detects subtle cognitive changes- CDR-SB measures the consequences. The Confidence Bridge: In external AD cohorts, correlation between cognitive composites and CDR-SB strengthens over time: r = 0.41 (early) → r = 0.65 (18 months). Cognition precede
Slide 52: Why CDR-SB Requires More Time: Evidence from External AD Cohorts
52 Why CDR-SB Requires More Time: Evidence from External AD Cohorts Enough Cognitive Change Must Occur to Measure Functional Change CDR-SB captures cognitive and functional consequences later – lagging indicator and registrational endpoint Conceptual framework. Curves are illustrative — not derived
Slide 53: Thank You!
53 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