Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (June 2025)
35 slides from Inmune Bio's investor presentation, Jun 30, 2025
Slide 1: Corporate Presentation June 2025
1 Corporate Presentation June 2025 NASDAQ: INMB
Slide 2: Forward Looking Statements
2 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 th
Slide 3: Three Platforms Modulating the Innate Immune System
a 3 XPro » TNF is the master regulator of the innate immune system and causes TNF dysfunction in many neurologic disease. » XPro TM is designed to reestablish normal TNF function to treat disease. CORDStrom » Mesenchymal Stromal cells (MSC) are recognized for their immunomodulatory, anti - inflammat
Slide 4: Approaching Alzheimer's as an Immunologic Disease
4 Approaching Alzheimer’s as an Immunologic Disease
Slide 5: Strong Evidence for XPro to Treat Alzheimer's Disease
5 Strong Evidence for XPro TM to Treat Alzheimer’s Disease Humans and Animals 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. Neu
Slide 6: TNF Biology – Two Ligands with Opposite Effects
6 TNF Biology – Two Ligands with Opposite Effects Created with BioRender.com .
Slide 7: XPro: A TNF Inhibitor Designed to Treat Neurologic Disease
7 XPro : A TNF Inhibitor Designed to Treat Neurologic Disease * Dominant - Negative in genetics: A mutation producing a rogue protein that interferes with the function of the native protein. Steed, Science 2003; Zalevsky , JI 2007; McCoy, JNeuro 2006; Vujanovic, Blood 2010; Brambilla, Brain 2011; Kh
Slide 8: Selective Inhibition of Soluble TNF is Necessary to Treat AD
8 Selective Inhibition of Soluble TNF is Necessary to Treat AD Disease Worsening Etanercept Non - selective TNF inhibition Disease (Model of Multiple Sclerosis) Adapted from: Karamita et al., 2017. Illustrations generated with bioRender . Normal XPro TM Disease Repair Soluble TNF inhibition
Slide 9: Phase 1b Trial in Alzheimer's Patients with Biomarkers of Inflammation
9 Phase 1b Trial in Alzheimer’s Patients with Biomarkers of Inflammation Key Results XPro1595 gets into the brain XPro1595 reduced biomarkers of AD pathology 43% reduction in pTau - 217 2% reduction in pTau181 XPro1595 dose - dependently reduced neuroinflammation 15% reduction in Neuroinflammation S
Slide 10: Phase 2 Trial Design: Early AD with Biomarkers of Inflammation
10 Key Enrollment Criterion □ Early AD (50 - 85 yrs) □ Amyloid positive □ CDR (0.5 or 1) □ MMSE > 22 □ Ecog >1.5 □ One Inflammatory Biomarker: □ hsCRP (1.5 mg/L) □ ESR (10 mmg / hr ) □ HbA1c (6%) □ APOE4+ Baseline □ EMACC □ Cognition □ Function □ Blood □ MRI Baseline Week 6 □ EMACC Week 12 □ EMACC □
Slide 11: EMACC and CDR: Primary Endpoints for Early AD Clinical Trials
11 EMACC CDR Clinically derived to stage AD Empirically derived to measure cognitive change in Early AD Clinically validated measurements No floor or ceiling effects Lower variance and shorter retest intervals provides smoother measure of cognitive change Greater dynamic range allows measure of stab
Slide 12: EMACC measures cognitive changes in early AD
12 EMACC measures cognitive changes in early AD Developed in 2017 to measure cognitive changes that occur in early Alzheimer's disease Quantitative/Objective/Sensitive EMACC objectively measures cognitive performance and is sensitive to the effects of disease progression and treatments Comprised of
Slide 13: Phase 2 Study Results
13 Phase 2 Study Results
Slide 14: XPro for Early AD: Background
14 XPro TM for Early AD: Background Neuroinflammation in AD • Recognized contributor to disease progression in AD 1 • Associated with synaptic dysfunction/loss and cognitive impairment across the AD continuum 2 • Implicated in neurotoxic gliosis and tau - related neurodegeneration downstream of amyl
Slide 15: XPro for Early AD: Phase 2 Study Design
15 XPro TM for Early AD: Phase 2 study Design MINDFuL : A Phase 2, Multicenter, Randomized, Double - Blind, Placebo - Controlled Trial in Participants with Early Alzheimer’s Disease Key Eligibility Criteria • Age (50 - 85 years) • Diagnosis of MCI or mAD 1 • Amyloid - beta (Aβ) positive • MMSE ≥ 22
Slide 16: XPro for Early AD: Study Design and Endpoints
16 XPro TM for Early AD: Phase 2 Study Design Change from Baseline (CFB) to Week - 24 Trial Endpoints • Early and Mild Alzheimer’s Cognitive Composite (EMACC) Primary Endpoint • Clinical Dementia Rating Scale – Sum of Boxes (CDR - SB) Key Secondary Endpoint • Everyday Cognition Scale (E - Cog) Secon
Slide 17: XPro for Early AD: Baseline Demographics
17 XPro TM for Early AD: Phase 2 Study Results Baseline Demographics (SAF Population) a Total (N=206) XPro TM (n=139) Placebo (n=67) Demographic 72.5 (6.51) 72.7 (6.40) 72.1 (6.75) Age, years 105 (51.0) 70 (50.4) 35 (52.2) Sex , n (%) Female 198 (95.1) 5 (2.4) 4 (1.9) 1 (0.5) 131 (94.2) 5 (3.6) 0 3
Slide 18: XPro for Early AD: Baseline Disease Characteristics
18 XPro TM for Early AD: Phase 2 Study Results Baseline Disease Characteristics (SAF Population) a Total (N=206) XPro TM (n=139) Placebo (n=67) Characteristic 199 1.15 (1.49) 135 1.20 (1.52) 64 1.05 (1.42) Time (yrs) since AD diagnosis, n Mean (SD) 93 (45.1) 113 (54.9) 62 (44.6) 77 (55.4) 31 (46.3)
Slide 19: XPro for Early AD: Topline Results
19 XPro TM for Early AD: Phase 2 Study Topline Results a A β + w/Inflammation = Amyloid - beta positive with ≥2 enrichment biomarkers of inflammation in blood Key Endpoint Effect Sizes (Cohen’s d) 0.11 - 0.06 - 0.05 0.2 0.17 0.23 - 0.05 0.27 -0.3 -0.2 -0.1 0 0.1 0.2 0.3 pTau-217 GFAP NPI-12 CDR-SB E
Slide 20: XPro for Early AD: Safety Results
20 XPro TM for Early AD: Phase 2 Study Results - Safety Safety: Treatment Emergent Adverse Events (TEAEs): Safety Analyses Set a Total (N=206) XPro TM (n=139) Placebo (n=67) Event, n (%) 190 (92.2) 131 (94.2) 59 (88.1) Any TEAE [1] 107 (51.9) 78 (37.9) 5 (2.4) 73 (52.5) 56 (40.3) 2 (1.4) 34 (50.7) 2
Slide 21: XPro for Early AD: Injection Site Reactions
21 XPro TM for Early AD: Phase 2 Study Results - Safety Safety: Injection Site Reactions (ISRs): Safety Analyses Set a Total (N=206) XPro TM (n=139) Placebo (n=67) Event, n (%) 119 (57.8) 112 (80.6) 7 (10.4) Hypersensitivity / Injection Site Reaction 46 (22.3) 115 (55.8) 43 (30.9) 111 (79.9) 3 (4.5)
Slide 22: XPro for Early AD: ARIA Safety
22 XPro TM for Early AD: Phase 2 Study Results - ARIA Safety: Amyloid - Related Imaging Abnormalities (ARIA) Safety Endpoints: Imaging • Comprehensive imaging protocol and review criteria focused on detection and grading of safety events in the brain XPro TM (n=139) Placebo (n=67) WK24 WK12 WK24 WK1
Slide 23: XPro for Early AD: Summary and Conclusions
23 XPro TM for Early AD: Summary and Conclusions • MINDFuL was a well designed and well executed clinical trial in Early AD x Successful enrollment of a well - balanced cohort of participants with MCI or mAD x Objective measure of cognitive performance with improved sensitivity for detection of disc
Slide 24: XPro Anticipated Next Steps and Timeline
24 XPro Anticipated Next Steps and Timeline July Sept Oct Nov Dec 2025 Aug Topline Data (AD02 ) June AAIC presentation (July 27 - 31) Phase 2 manuscript submission End of Phase 2 meeting with FDA, EMA, MHRA File breakthrough Designation
Slide 25: CORDStrom for RDEB
25 for RDEB CORDStrom
Slide 26: RDEB – An Ultra-Rare Genetic Disease with Significant Unmet Need
26 RDEB – An Ultra - Rare Genetic Disease with Significant Unmet Need *Recessive Dystrophic Epidermolysis Bullosa (RDEB) • RDEB is a severe form of epidermolysis bullosa (EB), a rare disease that causes severe skin fragility, itch and chronic pain • RDEB is caused by mutations in the COL7A1 gene tha
Slide 27: CORDStrom Platform Overview
27 CORDStrom Platform Overview Investigational disease - modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB) CORDStrom Overview • CORDStrom is an innovative cellular medicine, comprising allogeneic, pooled human umbilical cord - derived mesenchymal stromal cells ( hucMSCs ) for
Slide 28: CORDStrom Phase 2 Trial in Pediatric RDEB
Photography QoL iscorEB EBDASI Research bloods Photography QoL iscorEB EBDASI Photography Research bloods Photography QoL iscorEB EBDASI Safety bloods Photography Research bloods Photography QoL iscorEB EBDASI Photography QoL iscorEB EBDASI EBDASI Safety bloods Photography QoL iscorEB EBDASI Researc
Slide 29: Itch: Clinically Meaningful Endpoint
Itch: Clinically Meaningful Endpoint • 100% of kids have itch as an important clinical problem • FDA guidance highlights itch as a clinically important end - point* for RDEB • Itch Man Scale is a validated scales used in pediatric patients • Itch is as an endpoint used to approve drugs ( eg : atopic
Slide 30: Itch improved at 3 months and remained stable at 6 months
Itch improved at 3 months and remained stable at 6 months. 30 Itch: Clinically Meaningful Endpoint -50 -40 -30 -20 -10 0 10 20 30 40 50 <10yrs >10yrs Intermediate Severe ITCH Man results 6 months P a t i e n t g r o u p Favours CORDStrom Favours Placebo Insufficent data Score change (%) from pre-tre
Slide 31: CORDStrom for RDEB: Clinical and Qualitative Summary
CORDStrom for RDEB: Clinical and Qualitative Summary Clinical Benefits • Improvement in itch in all patient groups – the most common and complained of symptom in RDEB • In some patient groups • Less pain • Better iSCOREB wound score • Durable benefit of CORDStrom therapy for 6 months Qualitative Ben
Slide 32: Off-the-Shelf NK Therapeutic Candidate
32 Off - the - Shelf NK Therapic Candidate Converts Patient’s Resting NK cells into Cancer Killing Memory like NK cells
Slide 33: INKmune mCRPC Phase I/II Trial Design
33 Step 1: Short term safety Immunologic efficacy Middle - dose 1 1 1 6 patients High - dose 1 1 1 6 patients Step 2: Long term safety Immunologic efficacy Anti - tumor effects 6 patients Confirmatory group: SRC choses Middle or High dose for confirmatory data Low - dose 1 1 1 Trial will determine:
Slide 34: Anticipated Milestones in 2025 and 2026
34 XPro CORDStrom INKmune Anticipated Milestones in 2025 and 2026 Q3 Q1 Q2 Q3 Q4 2025 2026 BLA/MAA Submission Open Label Phase 2 mCRPC Data (Ongoing) Q4 End of Phase 2 FDA Meeting AD Complete Phase 2 mCRPC Enrollment
Slide 35: Contact Us
35 Contact Us: INmune Bio Inc. 225 NE Mizner Blvd.Suite 640 Boca Raton, FL 33432 (561) 710 - 0512 info@inmunebio.com INMB (Nasdaq)