Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (November 2021)
34 slides from Inmune Bio's investor presentation, November 2021
Slide 1: Harnessing the Power of the Innate Immune System
HARNESSING THE POWER OF THE INNATE IMMUNE SYSTEM Targeting Innate Immune Dysfunction INMB INVESTOR PRESENTATION November 2021
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: Investment Highlights
FOLLOW US INVESTMENT HIGHLIGHTS ▪ Patented therapies that repair dysfunction of the innate immune system to combat immune diseases including; Alzheimer’s Disease, Cancer, Treatment Resistant Depression and other serious conditions INMB ▪ Two unique platforms 1. DN-TNF: First selective TNF inhibitor
Slide 4: Targeting Innate Immune System Dysfunction
OUR STRATEGY TARGETING INNATE IMMUNE SYSTEM DYSFUNCTION The human immune system undergoes aging-related changes, which progress to a state of Innate immune system plays a immunosenescence and chronic inflammation. Chronic inflammation leads to age related critical and often overlooked role diseases
Slide 5: An Active Pipeline of Therapies That Target the Innate Immune Response
DEVELOPMENT AN ACTIVE PIPELINE OF THERAPIES THAT TARGET THE INNATE IMMUNE RESPONSE UPCOMING EVENTS DN-TNF PLATFORM DISEASE FIELD PRE-CLINICAL PHASE I PHASE II (POC) PIVOTAL EST. NEXT MILESTONE ▪ P2 AD Start 4Q 2021 ▪ P2 MCI Start 1H 2022 Mild Alzheimer’s P2 Start Disease CNS Q4 2021 ▪ P2 TRD Initiat
Slide 6: DN-TNF and INKmune: Tip of the Iceberg
TIP OF THE ICEBERG DN-TNF AND INKMUNE ▪ Visible programs AD, TRD, ALS ▪ “Out-of-Sight” PD, MS, FTD, LBD, TBI PTSD, autism, bi-polar disease Much, much, more…. ▪ Visible programs High risk MDS; Ovarian Cancer ▪ “Out-of-Sight” AML, MM, lymphoma RCC, Lung, prostate and breast cancer 6
Slide 7: Treating Alzheimer's Disease as an Immunologic Disease
for AD Treating Alzheimer’s Disease as an Immunologic Disease …not A Neurologic Disease 7
Slide 8: Breaking the Destructive Cycle of Neuroinflammation Driven by Glial Activation
OUR STRATEGY IN AD BREAKING THE DESTRUCTIVE CYCLE OF for AD NEUROINFLAMMATION DRIVEN BY GLIAL ACTIVATION Any Drug Therapy Must Stop Nerve Cell Death and Improve Synaptic Dysfunction Amyloid plaques Nerve Cell Neurofibrillary tangles Death Cognitive Behavioral, MICROGLIA Decline Environmental Synapti
Slide 9: Evidence for TNF in Alzheimer's Disease
Evidence for TNF in Alzheimer’s Disease for AD RISK OF ALZHEIMER’S Anti-TNFs protect against AD & Dementia DISEASE IN MAN Rheumatoid Arthritis, ankylosing spondylitis, psoriatic arthritis, Inflammatory bowel disease, ulcerative colitis, Crohn’s disease Risk of general population Adapted from Chou et
Slide 10: XPro for AD: State of the Art
TOPLINE RESULTS FROM PHASE I AD TRIAL XPro for AD: STATE OF THE ART for AD Highlights from on-going analysis of Phase I trial in patients with AD and biomarkers of neuroinflammation Neuroinflammation. Reduction in CSF and imaging biomarkers of neuroinflammation • ↓15% CSF Inflammation at 12 weeks (O
Slide 11: XPro Decreases Neuroinflammation
TARGET ENGAGEMENT FROM PHASE I TRIAL XPRO DECREASES NEUROINFLAMMATION 30 Free-water in AD bundles (% change) for AD 20 • CSF – XPro decreases 10 neuroinflammation after 0 12 weeks of therapy -10 XPro1595 1 mg/kg • MRI – XPro decreases -20 ADNI database N = 36 neuroinflammation after -30 12 months of
Slide 12: Benefits of Reducing Neuroinflammation
DOWNSTREAM EFFECTS OF TARGET ENGAGEMENT RESULTS FORM PHASE I TRAIL BENEFITS OF REDUCING NEUROINFLAMATION for AD Significant Regulation of AD Relevant Neuroinflammatory, Neural Injury, and Synaptic Proteins CSF Proteome 20 of 26 Targets Significant (P < 0.0001) Pre-specified Analysis Using tmtCalibra
Slide 13: XPro Improves White Matter Pathology
DOWNSTREAM BENEFITS OF TARGET ENGAGEMENT FROM PHASE I TRIAL XPRO IMPROVES WHITE MATTER PATHOLOGY for AD • AFD – apparent fiber density is a measure of axonal integrity. • Increased AFD means more/better/healthier axons • RD – radial density is a measure of myelin. • Decreasing RD means remyelination
Slide 14: XPro Effects on Traditional Biomarkers in AD
420000 Left Entorhinal vo Total White Matter 800 RESULSTS FROM PHASE I TRIAL 400000 XPRO EFFECTS ON “TRADITIONAL” BIOMARKERS IN AD 380000 700 for AD 360000 600 0 3 6 9 12 0 3 6 9 12 Visit (months) XPro increases White Matter brain volume volumetric Visit (months) analysis XPro decreases phospho Tau
Slide 15: Summary – XPro Phase I Trial in AD
SUMMARY – XPRO PHASE I TRIAL IN AD for AD ✓ White matter microstructure degenerates with Alzheimer’s Disease ✓ Neuroinflammation causes synaptic, axonal & myelin disruption/dysfunction ✓ XPro 1mg/kg once a week by subcutaneous injection is ✓Safe and well tolerated ✓Reduced neuroinflammation by 46% (
Slide 16: Phase 2 Trial in Mild AD with Biomarkers of Inflammation
PHASE 2 BLINDED, RANDOMIZED, PLACEBO-CONTROLLED for AD IN MILD AD WITH BIOMARKERS OF INFLAMMATION INCLUSION END-POINTS ▪ 200 patients ▪ Primary: EMACC* 2:1 randomization (134 XPro™ Internatonal Shopping List Test- Immediate recall patients vs 66 placebo patients) Digit Span Forward and Backward Cate
Slide 17: Phase 2 Trial in MCI AD with Biomarker of Inflammation
PHASE 2 BLINDED, RANDOMIZED, PLACEBO-CONTROLLED for AD IN MCI AD WITH BIOMARKER OF INFLAMMATION END-POINTS INCLUSION ▪ Primary: EMACC* ▪ 90 patients Internatonal Shopping List Test- Immediate recall 1:1:1 randomization - 30 patients Digit Span Forward and Backward per group Category fluency Test (2 c
Slide 18: Selective TNF Inhibitor of Soluble TNF
SELECTIVE TNF INHIBITOR OF SOLUBLE TNF for AD Not Competing with Currently Approved TNF Inhibitors or Biosimilars DN-TNF Neutralizes ONLY sTNF and Leaves The Benefits of INMB’s Selective vs. Non- tmTNF and TNF Receptors Free to Function Selective sTNF Inhibition whereas existing TNF inhibitors block
Slide 19: How XPro Neutralizes sTNF
HOW XPro™ NEUTRALIZES sTNF for AD And importantly leaves tmTNF and TNF receptors alone. sTNF and tmTMF Do Very Different Things… Nonglycosylated Protein Soluble TNF Function Eliminated Expressed in E. Coli No inflammatory signaling DN-TNF Can Not Neutralize tmTNF receptors not blocked so tmTNF biolo
Slide 20: Approved TNF Inhibitors Should Not Be Used in CNS
APPROVED TNF INHIBITORS SHOULD NOT BE for AD USED IN CNS Demyelination Is An Off-Target Safety Side Effect of Currently Approved TNF Therapies NORMAL CUPRIZONE ETANERCEPT DN-TNF Model of Multiple Sclerosis Anti-inflammatory AND Anti-inflammatory NOT immunosuppressive immunosuppressive EXACERBATED DE
Slide 21: Off-the-Shelf NK Therapy Producing Memory Like NK Cells
for Oncology Off-the-Shelf NK Therapy Producing memory like NK cells from Patient’s Own NK cells in Their Circulation (ie: in vivo) 21
Slide 22: INKmune: State of the Art
INKmune for treatment of cancer INKmune: STATE OF THE ART in Oncology On-going Phase I enrolling high-risk MDS patients in open label dose escalation trial Preclinical data. INKmune primes patients own NK cells • Active against hematologic and solid tumors • Functional in immunosuppressive hypoxic e
Slide 23: A Multi-Dimensional Pseudokine
A MULTI-DIMENSIONAL “PSEUDOKINE” in Oncology Moa #2 – InkMUNE™ Differentiates Resting NK to “Memory-Like” NK Cells Cytokine cocktail (IL-12/15/18) drives resting NK to memory-like NK (SciTranslMed 2016; Romee,Fenheger, et al) Inkmune Generates Memory-like NK Cells with a Single Pseudokine CD16 CD94
Slide 24: INKmune First in Human Trial – MDS/AML
INKmune First in Human Trial – MDS/AML Day 73 data - First Patient treated with INKmune IV (subject #3) in Oncology INKmune induces memory-like NK cells with INKmune activates tumor killing NK cells enhanced lysis of NK-sensitive (K562) and NK-resistant (RAJI) cells NKG2D+ NKcells In vitro Tumor Kil
Slide 25: A Multi-Dimensional Pseudokine: Avidity
A MULTI-DIMENSIONAL “PSEUDOKINE” in Oncology MoA #1 – INKmune™ Increases Avidity of NK Cell Binding to Tumor Cells • AVIDITY is a measure of how firmly an NK cell gets attached to Avidity of tumor cell binding by resting and a tumor cell target primed NK cells • The greater the AVIDITY the 100 SK-OV
Slide 26: INKmune Phase 1 Study
INKMUNE™ PHASE 1 STUDY in Oncology Phase I Trial in High-Risk MDS GOAL DESIGN Evaluate Safety and Open-label dose escalation study of Tolerability of INKmune™ in intravenous INKmune enrolling 9 patients High-Risk MDS INCLUSION FIRST IN HUMAN TRIAL OF INKMUNE™ Patients with MDS with excess blasts END
Slide 27: INKroc Phase 1 Study
INKROC™ PHASE 1 STUDY in Oncology Phase I Trial in Relapsed Platinum-resistant/refractory/intolerant ovarian cancer Open label Phase I/II Single Dose INKmune IP (n=6 subjects) Enrolment timetable (max enrolment rate) DSMB Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Maintenance follow
Slide 28: NK Competitive Landscape
NK COMPETITIVE LANDSCAPE in Oncology 18 Programs and Counting… THE VARIABLES ▪ A unique, stable cell line, not an NK cell ▪ Cytokines - single or multiple as a therapeutic or ▪ >180 unique genes induced in resting NK cells as part of cell therapy ▪ ↑NK survival = persistence ▪ NK cell source – ▪ ↑ N
Slide 29: Targeting Neuroinflammation for Treatment Resistant Depression
for TRD Targeting Neuroinflammation for TREATMENT RESISTANT DEPRESSION (TRD) 29
Slide 30: Treatment Resistant Depression
TREATMENT RESISTANT DEPRESSION (TRD) for TRD The Subset of People Who Have Failed At Least Two Anti Depressants 1 out of 3 MDD Economic Higher Chronic course TNF biology POC studies with anti-TNF patients or 33% of the toll: comorbidity of MDD in TRD blood CRP predicts response estimated 7M patients
Slide 31: TRD Is Driven by Inflammation
TRD IS DRIVEN BY INFLAMMATION for TRD ▪ 20 million adults have major depressive Plasma TNF levels are increased in TRD patients disorder (MDD) per year ▪ One third (~7 million patients) have Treatment Resistant Depression (TRD)1 ▪ Cost of TRD is nearly $64 billion2 Haroon et al., Psychoneuroendocrin
Slide 32: TNF Predicts TRD
TNF PREDICTS TRD for TRD Anti-TNF Therapy Improves Depression in Patients With Elevated Inflammatory Biomarkers Anti-tnf Treatment Reduces Depressive Symptoms In Patients With Elevated Biomarkers of Inflammation Inflammation-associated deficits in reward circuitry Treatment Response (≥50 reduction i
Slide 33: Phase 2 TRD Trial
PHASE 2 TRD TRIAL for TRD Supported by Small Business Innovation Research (SBIR) grant from the National Institutes of Health DESIGN BIOMARKERS OF INFLAMMATION Six-week double blind placebo-controlled study of Xpro™ MRI 45 patients in Xpro™ at 1 mg/kg WMFW as measure of neuroinflammation 45 patients
Slide 34: Contact Us
HARNESSING THE POWER CONTACT US OF THE INNATE IMMUNE SYSTEM INmune Bio Inc. 225 NE Mizner Blvd., Suite 640 Boca Raton, FL 33432 INMB (858) 964-3720 www.inmunebio.com 34