Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (February 2025)
46 slides from Inmune Bio's investor presentation, Feb 10, 2025
Slide 1: Corporate Presentation: Inflammation & Immunology Platforms
Corporate Presentation Inflammation & Immunology Platforms XPro / CORDStrom / INKmune ® INMB Nasdaq February 2025 v19
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 thes
Slide 3: Three Novel Platforms with Data in 2025
a 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 fro
Slide 4: Programs with Data Events in 2025
DISEASE FIELD PRE - CLINICAL PHASE 1 PHASE II (POC) PIVOTAL BLA Early Alzheimer’s Disease Top line EMACC June 2025 Recessive Dystrophic Epidermolysis Bullosa BLA December 2025 NK Priming Platform Data at NK Summit 1H25 Programs with “Data Events” in 2025 CORDStrom XPro INKmune Metastatic Castrate Re
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 la
Slide 6: CORDStrom Platform Overview
CORDStrom Platform Overview Investigational disease - modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB ) CORDStrom Overview • CORDStrom is a patent - pending cell medicine comprising allogeneic, pooled human umbilical cord - derived mesenchymal stromal cells (hucMSCs) in susp
Slide 7: CORDStrom Next Steps and Milestones
7 CORDStrom Next Steps and Milestones Productive conversations with FDA over the last few months have established a clear path forward BLA = Biologics License Application; EMA = European Medicines Agency; FDA = Food and Drug Administration; GOSH = Great Ormond Street Hospital; IND = Investigational
Slide 8: CORDStrom Blinded Randomized Crossover Trial Design
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 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 d
Slide 10: Itch: Clinically Meaningful Endpoint Results
Multiple clinical indicators improved at 3 - and 6 - months. The most clinically significant change was in severity of itch Itch: Clinically Meaningful Endpoint 10
Slide 11: 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 12: CORDStrom RDEB Open Label Trial
Photography QoL iscorEB EBDASI Safety bloods Research bloods Safety bloods Above plus Safety bloods Above plus Safety bloods Research bloods Research bloods Research bloods • 12 - month open label trial intermediate/severe RDEB • 3 cycles of CORDStrom (2 doses/cycle) • CORDStrom dosing at 0, 4 and 8
Slide 13: Treating Alzheimer's as an Immunologic Disease Driven by Neuroinflammation
13 for AD Treating Alzheimer’s as an Immunologic Disease Driven by Neuroinflammation
Slide 14: Treating Alzheimer's disease as an Immunologic disease
Activated Microglia sTNF and other cytokines NeuroInflammation Essential Pathologies of Cognitive Decline • Synaptic Dysfunction • Demyelination • Nerve Cell Death Treating Alzheimer’s disease as an Immunologic disease 14 XPro breaks the "Doom Loop" of Neuroinflammation and Cognitive Decline
Slide 15: TNF Inhibitors Reduce Risk of Developing AD
a Epidemiological studies including a meta - analysis of more than 60 million cases linking TNF Blocking Agents to reduced risk of AD +800% Rheumatoid Arthritis Risk of General Population Rheumatoid Arthritis + Anti - TNF treatment - 60% 15 TNF Inhibitors Reduce Risk of Developing AD sTNF causes Neu
Slide 16: Phase I Results: Neutralizing sTNF with XPro Decreases Neuroinflammation
16 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
Slide 17: XPro Decreases Neurodegeneration
17 XPro Decreases Neurodegeneration pTau217 is best biomarker for neurodegeneration in patients with AD* p<0.0001 p<0.01 Phase I data: XPro 1mg/kg subQ once a week for 12 weeks decrease pTau in CSF in patients with AD *https://jamanetwork.com/journals/jamaneurology/fullarticle/281375 1
Slide 18: XPro Improves Synaptic Function
18 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 treat
Slide 19: XPro: a TNF Inhibitor Designed to Treat Neurologic Disease
19 XPro : a TNF Inhibitor Designed to Treat Neurologic Disease XPro is identical to the human soluble TNF monomer with the exception of mutations in the receptor binding domain and another for pegylation. XPro : a dominant - Negative selective inhibitor of ONLY soluble TNF Dominant - Negative in gen
Slide 20: TNF: Two Cytokines, Same Name, Opposite Effects
20 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 p
Slide 21: XPro Unique Mechanism of Action
XPro unique Mechanism of Action XPro neutralizes sTNF without affecting tmTNF using dominant - negative technology XPro Targeting sTNF exchanges with sTNF monomers to form inactive heterotrimers Inflammatory TNF eliminated No paracrine signaling through receptors Preserving tmTNF Function tmTNF homo
Slide 22: XPro is the Only TNF Inhibitor That Is Safe for the Brain
• Currently approved TNF inhibitors are contraindicated in treatment of neurologic disease such as AD • promote demyelination (yellow arrow) • promote axon degeneration (white arrows) • XPro promotes remyelination and axonal regeneration Karamita; Therapeutic inhibition of soluble brain TNF promotes
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 □ EMACC Secondary Endpoints □ CDR - SB, ECog □ ADL, NPI □ Blood □ MRI □ Safety Treatment □ 2:1 (XPro : Placebo) □ 1 mg/kg XPro weekly subQ injection Unique design elements □ small and short □ enrichment, □ precise cogn
Slide 24: EMACC and CDR: Primary End-point for Early AD Clinical Trials
EMACC and CDR: Primary end - point for Early AD clinical trials 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
Slide 25: Phase 2 Trial Summary: Smaller, Shorter, Smarter
Phase 2 Trial Summary: Smaller ‖ Shorter ‖ Smarter ▪ 208 patients enrolled ▪ 56% mild AD, 44% MCI ▪ Enrichment for patients with elevated neuroinflammation (ADi) decreases risk ▪ AD patients with inflammation progress faster and more reliably allowing for smaller trial size and shorter duration ▪ EM
Slide 26: Off-the-Shelf NK Therapy Converts Resting NK Cells into Cancer Killing Cells
26 Off - the - Shelf NK Therapy Converts Patient’s Resting NK cells into Cancer Killing memory like NK cells
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 MicroEnv ironment (TME) of PC • Prostate cancer immune infiltrate cells are resting NK cells NOT T cells • Is lack of T cell infiltrate why immune checkpoint inhibitors fail in m
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 proteomic s GATB GATC GFM2 HARS1 HARS2 LARS2 MRPL10 MRPL16 MRPL2 MRPL23 MRPL47 MRPL51 MRPL57 MRPS11 MRPS12 MRPS15 MRPS16 MRPS17 MRPS18A MRPS18B MRPS18C MRPS2 MRPS21 MRPS24 MRPS34 MRPS6 MRPS7 NDUFA7
Slide 29: INKmune mCRPC Phase I/II Trial Design
INKmune ® mCRPC Phase I/II Trial Design Low - dose Middle - dose High - dose 1 1 1 1 1 1 1 1 1 Step 1: Short term safety Immunologic efficacy 6 patients 6 patients Step 2: Long term safety Immunologic efficacy Anti - tumor effects 6 patients Confirmatory group In this example: SRC choses middle dose
Slide 30: Anticipated Milestones in 2024 and 2025
Anticipated Milestones in 2024 and 2025 EXPECTED TIMING EVENT June 2025 Topline Cognition data Phase 2 AD 3/4Q 2025 End of Phase 2 FDA Meeting AD 1H 2025 First patient TRD study Dec 2025 BLA submission RDStrom Jan 2025 3Q 2025 Completed Phase 1 mCRPC Enrollment Complete Phase 2 mCRPC Enrollment Ongo
Slide 31: Contact Us: INmune Bio Inc.
Contact Us: 31 INmune Bio Inc. 225 NE Mizner Blvd.Suite 640 Boca Raton, FL 33432 (858) 964 - 3720 info@inmunebio.com v19 Symbol: INMB (Nasdaq) Inflammation and Immune Repair
Slide 32: What is CORDStrom and Why is it Different?
What is CORDStrom and Why is it Different? What is CORDStrom? • Pooled, allogeneic, umbilical cord derived Mesenchymal Stromal/Stem Cell (MSC) platform • Global IP pending (composition & use) with potential term through 2045 • Available Off - The - Shelf as cryopreserved drug • Large Volume Manufact
Slide 33: Targeting AD as an Immunologic Disease: a Novel Approach to a Silent Epidemic
3 Targeting AD as an Immunologic Disease: a Novel Approach to a Silent Epidemic • 13% of elderly have AD (age≥65) • Elderly population increases by 50% by 2040 to 81M • 35% of age≥85 has AD • Number of people age≥85 will double by 2040 to 13.7M Reality : the number of people with AD dementia in the
Slide 34: Neuroinflammation Comes First
34 • sTNF drives expression and accumulation of amyloid • Targeting sTNF should stop amyloid deposition Aβ Amyloid plaque 3 Blasko et al.1999 β - secretase β - secretase 2 APP 1 Lahiri et al.2003 Chicken or Egg ? : Neuroinflammation Comes First Yamamoto et al., 2007
Slide 35: XPro Gets into the Brain in Therapeutically Relevant Concentrations
XPro gets into the brain in therapeutically relevant concentrations This is not a formal GLP PK study. These are TNF levels measured in the OLINK cytokine platform. The TNF assays measure both native soluble TNF and XPro 35
Slide 36: Phase 2 Trial Summary: Smaller, Shorter, Smarter
Phase 2 Trial Summary: Smaller, Shorter, Smarter Enrichment for neuroinflammation selects for patients that get worse faster and more reliably to improve statistical power and precision 36
Slide 37: Simple Enrichment Criteria for EAD with Neuroinflammation
Simple Enrichment Criteria used to select patients with EAD with Neuroinflammation – matching XPro MOA with disease driver 37 Peripheral Inflammation causes Central Inflammation Increased Risk of AD Enrichment Factor Peripheral Disease 3 ApoE4 Genetic 1.84 ESR Peripheral inflammation 1.34 CRP Cardio
Slide 38: EMACC – a Stress Test for the Brain
EMACC – a stress test for the brain! Cognitive test that is “purpose built” for Early AD CDR Relationship 0.39 Treatment Lecanemab vs Placebo 0.45 CDR Frequency of contact 0.57 0.67 38 Sims et al 2023, vanDyck et al 2003, Vargas - Gonzalez et al 2024 Treatment Donanemab vs Placebo Magnitude of effec
Slide 39: EMACC: Why Was It Developed?
EMACC: Why Was It Developed? Preclinical MCI Symptomatic Alzheimer’s Disease Mild Dementia Moderate AD At - Risk PACC Early Alzheimer's Disease (EAD) INmune Bio's Study Population EMACC ADAS - Cog 39 CDR Global Rating: 0 0.5 1 2 3
Slide 40: EMACC Stress Test For The Brain: Objective Scoring
EMACC "Stress Test For The Brain" Objective Scoring EMACC Subtest Number of words recalled (0 - 36) Word List Learning Test Number of sequences recalled Digit Span Number of words produced in 1 minute Category and Letter Fluency Number of symbols produced in 2 minutes Digit Symbol Coding Number of s
Slide 41: EMACC: Fit For Purpose
EMACC: Fit For Purpose Data shows EMACC's reliability and validity in Early AD Quantitative Objective Sensitiv e r=0.93 (p<0.001) Baseline EMACC Score Screening EMACC Score • Reliable measure of cognitive performance • No rater/informant measurement error Frequency 41 Baseline EMACC scores • No floo
Slide 42: Remodeling and Repair of White Matter Tracts After XPro
42 Baseline 3 months 6 months 9 months ▪ 65 - year - old white male retired due to AD ▪ Returned to work after 6 months of XPro therapy ▪ Increasing green/blue shows improvement in axonal quality Remodeling and Repair of White Matter Tracts After XPro Phase 1b patient: CHANGES IN AFD* IN AD WHITE MA
Slide 43: Treatment Resistant Depression (TRD)
43 Treatment Resistant Depression (TRD) ▪ Drug development in psychiatry is a “one size fits all” approach ▪ 200+ ways to be diagnosed with depression ▪ There are 200+ symptom combinations that will lead to a depression diagnosis ▪ No Biomarkers ▪ High placebo response ▪ Drug development failure rat
Slide 44: Phase 2 TRD Trial Supported by SBIR Grant
Phase 2 TRD Trial Supported by Small Business Innovation Research (SBIR) grant from the National Institutes of Health DESIGN ▪ Six - week double blind placebo - controlled study of XPro1595 ▪ 45 patients in XPro1595 at 1 mg/kg ▪ 45 patients in placebo control group ▪ Biomarkers of inflammation at 0,
Slide 45: Inflammation is Associated with Symptom Severity in Depressed Patients
Inflammation is associated with symptom severity in Depressed patients 45
Slide 46: Problem: Value Proposition of Treatments for mCRPC is Poor
46 Problem: Value Proposition (efficacy vs toxicity) of treatments for mCPRC is Poor • The Facts : • Incidence of prostate cancer increasing - > 50 , 000 mCRPC patients in US • Current therapies average < 6 month survival benefit • Safety profile not ideal in patients (avg age : 76 years old) Severe