Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (February 2025)
31 slides from Inmune Bio's investor presentation, February 2025
Slide 1: Corporate Presentation: Inflammation & Immunology Platforms
Corporate Presentation Inflammation & Immunology Platforms XPro / CORDStrom / INKmune ® INMB February 2025 v19 Nasdaq
Slide 2: 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 3: Three Novel Platforms with Data in 2025
Three Novel Platforms with Data in 2025 ➢ CORDStrom Completed Blinded Randomized Trial in Recessive Dystrophic Epidermolysis Bullosa (RDEB) o Clinical benefit in RDEB patients treated with CORDStrom o US BLA Submission December 2025 o Granted Orphan Drug and Rare Pediatric Disease Designations from
Slide 4: Programs with Data Events in 2025
Programs with “Data Events” in 2025 DISEASE FIELD PRE-CLINICAL PHASE 1 PHASE II (POC) PIVOTAL BLA Pooled MSC Platform CORDStrom Recessive Dystrophic BLA Epidermolysis Bullosa December 2025 DN-TNF Platform Early Alzheimer’s Top line EMACC XPro Disease June 2025 NK Priming Platform Metastatic Castrate
Slide 5: RDEB – An Ultra-Rare Genetic Disease with Significant Unmet Need
RDEB – An Ultra-Rare Genetic Disease with Significant Unmet Need • 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 that makes type VII collagen, a protein that holds the laye
Slide 6: CORDStrom Platform Overview
CORDStrom Platform Overview Investigational disease-modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB) CORDStrom Overview Mission EB Phase 2 Trial • CORDStrom is a patent-pending cell medicine • Completed by investigators at GOSH in the UK and primarily funded comprising allog
Slide 7: CORDStrom Next Steps and Milestones
CORDStrom Next Steps and Milestones Productive conversations with FDA over the last few months have established a clear path forward Completed Type C meeting with FDA; CORDStrom was granted RPDD and ODD by FDA ✓ for the treatment of EB Publication of CORDStrom/MissionEB study in academic journal Ope
Slide 8: Mission EB Trial Design
Mission EB Trial Design: Double-Blind Randomized Crossover Trial in Children with RDEB CORD- CORD- Strom Strom CORD- CORD- Strom Strom EBDASI Photography Photography Photography Photography Photography Photography Photography Photography Safety QoL Research QoL QoL QoL Research QoL QoL bloods iscorE
Slide 9: 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 der
Slide 10: Itch: Clinically Meaningful Endpoint
Itch: Clinically Meaningful Endpoint Multiple clinical indicators improved at 3- and 6-months. The most clinically significant change was in severity of itch 10
Slide 11: CORDStrom for RDEB: Clinical and Qualitative Summary
CORDStrom for RDEB: Clinical and Qualitative Summary Clinical Benefits Qualitative Benefits • Improvement in itch in all patient groups – • 10 of 13 respondents confirm benefit of therapy the most common and complained of on clinical problems of itch, wound care and symptom in RDEB QOL • In some pat
Slide 12: CORDStrom RDEB open label trial
CORDStrom RDEB open label trial • 12-month open label trial intermediate/severe RDEB • Primary end-point: Itch • 3 cycles of CORDStrom (2 doses/cycle) • Secondary End-points: • CORDStrom dosing at 0, 4 and 8 months pain, EBDASI, iscorEB, • Two sites in UK plus US sites (US sites TBD) QOL, wound clos
Slide 13: Treating Alzheimer's as an Immunologic Disease Driven by Neuroinflammation
for AD Treating Alzheimer’s as an Immunologic Disease Driven by Neuroinflammation 13
Slide 14: Treating Alzheimer's disease as an Immunologic disease
Treating Alzheimer’s disease as an Immunologic disease XPro breaks the "Doom Loop" of Neuroinflammation and Cognitive Decline Essential Pathologies NeuroInflammation of Cognitive Decline • Synaptic sTNF and Dysfunction other cytokines Activated • Demyelination Microglia • Nerve Cell Death 14
Slide 15: sTNF causes Neuroinflammation that causes AD
sTNF causes Neuroinflammation that causes AD Prevention of chronic inflammation with anti-TNF therapy lowers risk of AD TNF Inhibitors Reduce Risk of Developing AD +800% Rheumatoid a Arthritis Risk of General Population Rheumatoid Arthritis -60% + Anti-TNF treatment Epidemiological studies including
Slide 16: Phase I Results: Neutralizing sTNF with XPro Decreases Neuroinflammation
Phase I Results: Neutralizing sTNF with XPro Decreases Neuroinflammation Dose-dependent reduction of CSF biomarkers of neuroinflammation in AD patients CSF *1 mg/kg group (N=6) Phase I results using Olink® Target 48 Cytokine assay in CSF 16
Slide 17: XPro Decreases Neurodegeneration
XPro Decreases Neurodegeneration pTau217 is best biomarker for neurodegeneration in patients with AD* Phase I data: XPro 1mg/kg subQ once a week for 12 weeks decrease pTau in CSF in patients with AD p<0.0001 p<0.01 *https://jamanetwork.com/journals/jamaneurology/fullarticle/281375 1 17
Slide 18: XPro Improves Synaptic Function
XPro Improves Synaptic Function Phase I studies demonstrated changes in synaptic proteins that correspond to improvements in synaptic function as measured by EEG Alpha waves Synaptic Proteins Contactin-2 +222% increase Neurogranin -56% decrease Above: CSF synaptic proteins improved after treatment w
Slide 19: XPro: a TNF Inhibitor Designed to Treat Neurologic Disease
XPro : a TNF Inhibitor Designed to Treat Neurologic Disease XPro : a dominant-Negative selective inhibitor of ONLY soluble TNF XPro 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:
Slide 20: TNF: Two Cytokines, Same Name, Opposite Effects
TNF: Two Cytokines, Same Name, Opposite Effects Currently approved TNF inhibitors block both types of TNF causing immunosuppression and demyelination Soluble TNF cause inflammation, cell death and demyelination Transmembrane TNF promotes immune function, is neuroprotective and improves synaptic plas
Slide 21: XPro unique Mechanism of Action
XPro unique Mechanism of Action XPro neutralizes sTNF without affecting tmTNF using dominant-negative technology Targeting sTNF Preserving tmTNF Function XPro exchanges with sTNF monomers to tmTNF homotrimers are anchored to the cell form inactive heterotrimers membrane; XPro cannot exchange Inflamm
Slide 22: XPro is the only TNF inhibitor that is safe for the Brain
XPro is the only TNF inhibitor that is safe for the Brain FDA label on currently approved TNF inhibitors recommend against use for CNS disease • Currently approved TNF inhibitors Etanercept XPro are contraindicated in treatment of neurologic disease such as AD • promote demyelination (yellow Myelin
Slide 23: Phase 2 Trial of XPro in Patients with Early Alzheimer's Disease
Phase 2 Trial of XPro in Patients with Early Alzheimer's Disease Primary Endpoint Treatment ❑EMACC ❑ 2:1 (XPro : Placebo) ❑ 1 mg/kg XPro weekly subQ Secondary Endpoints injection ❑CDR-SB, ECog ❑ADL, NPI ❑Blood Unique design elements ❑MRI ❑small and short ❑Safety ❑enrichment, ❑precise cognitive end-p
Slide 24: EMACC and CDR: Primary end-point for Early AD clinical trials
EMACC and CDR: Primary end-point for Early AD clinical trials CDR EMACC 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 co
Slide 25: Phase 2 Trial Summary: Smaller, Shorter, Smarter
Phase 2 Trial Summary: Smaller ‖ Shorter ‖ Smarter Top Line Cognition Results Expected June 25 ▪ 208 patients enrolled CDR-SB Lecanemab Phase III trial (C. van Dyck, et al, 2023 NEJM) ▪ 56% mild AD, 44% MCI Stable cognition is ▪ Enrichment for patients with elevated goal neuroinflammation (ADi) decr
Slide 26: Off-the-Shelf NK Therapy Converts Patient's Resting NK cells
Off-the-Shelf NK Therapy Converts Patient’s Resting NK cells into Cancer Killing memory like NK cells 26
Slide 27: Use INKmune to Match Therapy with Cancer Biology
Solution: Use INKmune® to Match Therapy with Cancer Biology INKmune targets the immune cells most prominent in the Tumor MicroEnvironment (TME) of PC Normal vs Tumor • Prostate cancer immune infiltrate cells are resting NK cells NOT T cells • Is lack of T cell infiltrate why immune checkpoint inhibi
Slide 28: INKmune Primed NK Cells Fitter Than Cytokine Primed NK Cells
INKmune® Primed NK Cells “Fitter” Than Cytokine Primed NK Cells rNK LAK-15 CIML-NK INKMUNE-TpNK Change in mitochondrial survival proteins following priming 3 TpNK Log change from rNK (Average Log ratio) 2 CIML IL15 1 0 proteomics -1 -2 GATB GATC GFM2 HARS1 HARS2 LARS2 MRPL10 MRPL16 MRPL2 MRPL23 MRPL
Slide 29: INKmune mCRPC Phase I/II Trial Design
INKmune® mCRPC Phase I/II Trial Design Step 1: Step 2: Short term safety Long term safety Confirmatory group Immunologic Immunologic efficacy In this example: SRC choses efficacy Anti-tumor effects middle dose for pivotal trial Low-dose 1 1 1 Now enrolling Middle-dose 1 1 1 6 patients High-dose 1 1
Slide 30: Anticipated Milestones in 2024 and 2025
Anticipated Milestones in 2024 and 2025 Key Upcoming Clinical & Regulatory Milestones EVENT EXPECTED TIMING Topline Cognition data Phase 2 AD June 2025 End of Phase 2 FDA Meeting AD 3/4Q 2025 First patient TRD study 1H 2025 CORDStrom BLA submission Dec 2025 Completed Phase 1 mCRPC Enrollment Jan 202
Slide 31: Inflammation and Immune Repair – Contact Us
Contact Us: Inflammation and INmune Bio Inc. Immune Repair 225 NE Mizner Blvd.Suite 640 Boca Raton, FL 33432 (858) 964-3720 info@inmunebio.com v19 Symbol: INMB (Nasdaq) 31