Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (November 2024)
27 slides from Inmune Bio's investor presentation, Nov 13, 2024
Slide 1: Inflammation and Immunology Repair: Two Platforms in the Clinic
Inflammation and Immunology Repair Two Platforms in the Clinic: XPro and INKmune INMB Nasdaq November 2024 v4b
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: Two Novel Platforms with Near Term Data
a 3 Two Novel Platforms with Near Term Data » XPro : Treating Alzheimer's as an Immunologic disease, not a neurologic disease o Phase 2 Alzheimer's top - line expected in Q2 2025 o Treatment Resistance Depression program open by year - end 2024 » INKmune : Creates memory - like NK Cells to kill canc
Slide 4: Development Timeline: XPro and INKmune
4 DN - TNF PLATFORM DESEASE FIELD PRE - CLINICAL PHASE 1 PHASE II (POC) PIVOTAL EST.NEXT MILESTONE Early Alzheimer’s Disease Full Enrollment Q3 - 2024 Topline Data ~ 6m Later Treatment Resistant Depression Phase 2 open year - end 2024 NK PRIMING PLATFORM Metastatic Castrate Resistant Prostate Cancer
Slide 5: Treating Alzheimer's as an Immunologic Disease, not a Neurologic Disease
5 Treating Alzheimer’s as an Immunologic Disease … not a Neurologic Disease for AD XPro
Slide 6: The Doom Loop of Neuroinflammation and Cognitive Decline
6 Activated Microglia sTNF and other cytokines NeuroInflammation Essential Pathologies of Cognitive Decline • Synaptic Dysfunction • Demyelination • Nerve Cell Death Targeting neuroinflammation with XPRO should stop cognitive decline to allow remodeling and repair The "Doom Loop" of Neuroinflammatio
Slide 7: TNF Inhibitors Reduce Risk of Developing AD
a 7 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% TNF Inhibitors Reduce Risk of Developing AD Targeting sTNF i
Slide 8: Soluble TNF Drives Pathology of Alzheimer's
8 • 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 Soluble TNF Drives Pathology of Alzheimer's sTNF drives neuroinflammation that promotes amyloid plaque d
Slide 9: Neutralizing sTNF with XPro Decreases Neuroinflammation
9 Neutralizing sTNF with XPro Decreases Neuroinflammation Dose - dependent reduction of CSF biomarkers of neuroinflammation in AD patients CSF Phase I results using Olink ® Target 48 Cytokine assay in CSF *1 mg/kg group (N=6)
Slide 10: XPro Decreases Neurodegeneration
10 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/2813751
Slide 11: XPro Improves Synaptic Function
11 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 12: Remodeling and Repair of White Matter Tracts After XPro
12 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 13: XPro: a TNF Inhibitor Designed to Treat Neurologic Disease
13 XPro : a TNF Inhibitor Designed to Treat Neurologic Disease XPro i s 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 g
Slide 14: TNF: Two Cytokines, Same Name, Opposite Effects
14 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 15: XPro Unique Mechanism of Action
15 XPro unique Mechanism of Action XPro neutralizes sTNF without affecting tmTNF using dominant - negative technology Targeting sTNF XPro exchanges with sTNF monomers to form inactive heterotrimers Inflammatory TNF eliminated No paracrine signaling through receptors Preserving tmTNF Function tmTNF h
Slide 16: XPro is the Only TNF Inhibitor That is Safe for the Brain
16 • 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 promo
Slide 17: Phase 2 Trial of XPro in Patients with Early Alzheimer's Disease
17 Phase 2 Trial of XPro in Patients with Early Alzheimer's Disease Primary Endpoint □ EMACC Secondary Endpoints □ CDR, 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 cognit
Slide 18: EMACC and CDR: Primary End-point for Early AD Clinical Trials
18 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
Slide 19: Phase 2 Trial Summary: Smaller, Shorter, Smarter
19 Phase 2 Trial Summary: Smaller, Shorter, Smarter ▪ 208 patients enrolled ▪ 56% mild AD, 44% MCI ▪ Enrichment for patients with elevated neuroinflammation ( ADi ) improves precision ▪ AD patients with inflammation progress faster and more reliably allowing for smaller trial size and shorter durati
Slide 20: Off-the-Shelf NK Therapy Converts Resting NK Cells into Cancer Killing Cells
20 Off - the - Shelf NK Therapy Converts Patient’s Resting NK cells into Cancer Killing memory like NK cells
Slide 21: Problem: Value Proposition of Treatments for mCRPC is Poor
21 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 (grad
Slide 22: Solution: Use INKmune to Match Therapy with Cancer Biology
22 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
Slide 23: INKmune Primed NK Cells Fitter Than Cytokine Primed NK Cells
23 INKmune Primed NK Cells “Fitter” Than Cytokine Primed NK Cells rNK LAK - 15 CIML - NK INKMUNE - TpNK proteomics G A T B G A T C G F M 2 H A R S 1 H A R S 2 L A R S 2 M R P L 1 0 M R P L 1 6 M R P L 2 M R P L 2 3 M R P L 4 7 M R P L 5 1 M R P L 5 7 M R P S 1 1 M R P S 1 2 M R P S 1 5 M R P S 1 6 M
Slide 24: INKmune mCRPC Phase I/II Trial Design
24 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 dos
Slide 25: Our Goal: Use XPro to Prevent Cognitive Decline in Early AD
a 25 » Our Goal: Use XPro to PREVENT cognitive decline in Early AD » Why: XPro targets the most important pathology in AD – neuroinflammation » How: Use a modern precision medicine clinical trial design to derisk the clinical program by matching the XPro MOA with the patient’s disease Ideal Treatmen
Slide 26: Anticipated Milestones in 2024 and 2025
26 Anticipated Milestones in 2024 and 2025 EXPECTED TIMING EVENT Q2 2025 Topline Phase 2 AD Data Q3 2025 End of Phase 2 FDA Meeting AD 2H 2024 Pre - clinical Anti - AB and XPro Data 2H 2024 Initiate Phase 2 TRD Trial 1H 2025 Complete Phase 2 mCRPC Enrollment Ongoing Open Label Phase 2 mCRPC Data Key
Slide 27: Contact Us
27 Contact Us: INmune Bio Inc. 225 NE Mizner Blvd.Suite 640 Boca Raton, FL 33432 (858) 964 - 3720 info@inmunebio.com Investor Relations: Daniel Carlson (415) 509 - 4590 daniel@inmunebio.com Mike Moyer (617) 308 - 4306 mmoyer@lifesciadvisors.com Symbol: INMB (Nasdaq) Inflammation and Immunology Repai