Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (July 2025)
30 slides from Inmune Bio's investor presentation, Jul 29, 2025
Slide 1: Corporate Presentation August 2025
1 Corporate Presentation August 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: Rationale and Background for XPro1595 in Alzheimer's Disease
9 Rationale and Background for XPro1595 in Alzheimer’s Disease 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 neurodege
Slide 10: Phase 2 Study Design and Key Enrollment Criteria
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: Phase 2 Study Results
11 Phase 2 Study Results
Slide 12: Baseline Demographics / Disease Characteristics
Baseline Demographics / Disease Characteristics (SAF Population) a Total (n=206) XPro 1595 (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 (female), n (%) 198 (95.1%) 131 (94.2%) 65 (97.0%) Race (white), n (%) 192 (96.1%) 134 (9
Slide 13: Population Changes Due to Operational Limitations
13 Population Changes Due to Operational Limitations 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 Criteria: Revised Protocol
Slide 14: Enriched Population: Primary and Key Secondary Endpoints
14 Enriched Population (n=100): Primary and Key Secondary Endpoints Change From Baseline EMACC: LS Mean Diff (SE): 0.086 (0.0603) , 90% CI: - 0.0146, 0.1857 , p - value: 0.1594. CDR - SB: LS Mean Diff (SE): - 0.08 (0.307) , 90% CI: - 0.593, 0.426 , p - value: 0.7859. NPI: LS Mean Diff (SE): - 1.6 (1
Slide 15: Enriched Population: Most Endpoints Favor Treatment with XPro1595
15 Enriched Population: Most Endpoints Favor Treatment with XPro1595 Depicted as absolute effect sizes (Cohen’s D) Effect size (Cohen’s D) EMACC: Early and Mild Alzheimer's Cognitive Composite . ISRL: International Shopping List Delayed Recall. CDR - SB: Clinical Dementia Rating – Sum of Boxes. NPI:
Slide 16: No ARIA
16 No ARIA Despite inclusion of patients at risk for ARIA ARIA - E = amyloid - related imaging abnormalities - edema/effusions; ARIA - H=amyloid - related imaging abnormalities - microhemorrhages/hemosiderin deposits; SAF = Safety Analysis Set Total (n=206) XPro 1595 (n=139) Placebo (n=67) ARIA Trea
Slide 17: XPro1595 has a Favorable Safety Profile
17 XPro1595 has a Favorable Safety Profile Safety: Treatment Emergent Adverse Events (TEAEs): Safety Analyses Set Total (n=206) XPro1595 (n=139) Placebo (n=67) Event, n (%) 190 (92.2%) 131 (94.2%) 59 (88.1%) Any TEAE 107 (51.9%) 78 (37.9%) 5 (2.4%) 73 (52.5%) 56 (40.3%) 2 (1.4%) 34 (50.7%) 22 (32.8%
Slide 18: Summary and Conclusions
18 Summary and Conclusions mITT population □ The primary end point was not met in the mITT population. □ The mITT study population (n=200) did not decline in the 6 - month period. □ Decline was observed in the originally intended population ( the enriched population) having amyloid and 2 or more bio
Slide 19: XPro Anticipated Next Steps and Timeline
19 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 20: CORDStrom for RDEB
20 for RDEB CORDStrom
Slide 21: RDEB – An Ultra-Rare Genetic Disease with Significant Unmet Need
21 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 22: CORDStrom Platform Overview
22 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 23: Phase 2 Trial Design in Pediatric RDEB Patients
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 24: 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 25: Itch Improved at 3 Months and Remained Stable at 6 Months
Itch improved at 3 months and remained stable at 6 months. 25 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 26: 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 27: Off-the-Shelf NK Therapeutic Candidate INKmune
27 Off - the - Shelf NK Therapic Candidate Converts Patient’s Resting NK cells into Cancer Killing Memory like NK cells
Slide 28: INKmune mCRPC Phase I/II Trial Design
28 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 29: Anticipated Milestones in 2025 and 2026
29 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 30: Contact Us
30 Contact Us: INmune Bio Inc. 225 NE Mizner Blvd.Suite 640 Boca Raton, FL 33432 (561) 710 - 0512 info@inmunebio.com INMB (Nasdaq)