Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (November 2021)
34 slides from Inmune Bio's investor presentation, Nov 4, 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 the
Slide 3: 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 ▪ Two unique platforms 1. DN - TNF : First selective TNF inhibitor targeting inflammation without dem
Slide 4: Targeting Innate Immune System Dysfunction
4 Pulmonary Disease Autoimmune Disease Metabolic Disease Neurological Disease Cardiovascular Disease Infectious Disease Innate immune system plays a critical and often overlooked role in host protection and normal function 50% of all deaths are attributable to inflammation - related diseases 1 1 Fur
Slide 5: An Active Pipeline of Therapies That Target the Innate Immune Response
DN - TNF PLATFORM DISEASE FIELD PRE - CLINICAL PHASE I PHASE II (POC) PIVOTAL EST. NEXT MILESTONE Mild Alzheimer’s Disease CNS P2 Start Q4 2021 MCI P2 Start 1H 2022 Treatment Resistant Depression P2 Start 1H 2022 NK PRIMING PLATFORM Myelodysplastic Syndrome ONCOLOGY P1 Underway 5 UPCOMING EVENTS ▪ P
Slide 6: DN-TNF and INKmune: Tip of the Iceberg
▪ 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 DN - TNF AND INKMUNE TIP OF THE ICEBERG 6
Slide 7: Treating Alzheimer's Disease as an Immunologic Disease
Treating Alzheimer’s Disease as an Immunologic Disease … not A Neurologic Disease for AD 7
Slide 8: Breaking the Destructive Cycle of Neuroinflammation Driven by Glial Activation
for AD 8 BREAKING THE DESTRUCTIVE CYCLE OF NEUROINFLAMMATION DRIVEN BY GLIAL ACTIVATION Any Drug Therapy Must Stop Nerve Cell Death and Improve Synaptic Dysfunction OUR STRATEGY IN AD sTNF Amyloid plaques Neurofibrillary tangles Behavioral, Environmental and Genetic factors MICROGLIA Nerve Cell Deat
Slide 9: Evidence for TNF in Alzheimer's Disease
for AD 9 Adapted from Zhou et al. 2019 Anti - TNFs protect against AD & Dementia Rheumatoid Arthritis, ankylosing spondylitis, psoriatic arthritis, Inflammatory bowel disease, ulcerative colitis, Crohn’s disease Evidence for TNF in Alzheimer’s Disease RISK OF ALZHEIMER’S DISEASE IN MAN Risk of gener
Slide 10: XPro for AD: State of the Art
for AD 10 XPro for AD : STATE OF THE ART Highlights from on - going analysis of Phase I trial in patients with AD and biomarkers of neuroinflammation TOPLINE RESULTS FROM PHASE I AD TRIAL Neuroinflammation. Reduction in CSF and imaging biomarkers of neuroinflammation 15% CSF Inflammation at 12 weeks
Slide 11: XPro Decreases Neuroinflammation
• CSF – XPro decreases neuroinflammation after 12 weeks of therapy • MRI – XPro decreases neuroinflammation after 12 months of therapy 1mg/kg group 11 XPro™ (1 Mg/Kg; N=6) Reduced Whole Brain Neuroinflammation (12 Weeks ) MRI WMFW ~5% decline for AD -50% -45% -40% -35% -30% -25% -20% -15% -10% -5% 0
Slide 12: XPro Decreases Neuronal Injury and Improves Synaptic Dysfunction
XPro™ DECREASES Neuronal Injury for AD 12 20 of 26 Targets Significant (P < 0.0001) CSF Proteome XPro™ IMPROVES Synaptic Dysfunction 222 % Contactin - 2 56 % Neurogranin 91 % Visinin - like Protein 1 84 % Neurofilament Light Chain Pre - specified Analysis Using tmtC alibrator™ Significant Regulation
Slide 13: XPro Improves White Matter Pathology
13 for AD XPRO IMPROVES WHITE MATTER PATHOLOGY DOWNSTREAM BENEFITS OF TARGET ENGAGEMENT FROM PHASE I TRIAL • 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 remyelinat
Slide 14: XPro Effects on Traditional Biomarkers in AD
for AD XPRO EFFECTS ON “TRADITIONAL” BIOMARKERS IN AD 14 0 3 6 9 12 360000 380000 400000 420000 440000 460000 Visit (months) T o t a l W h i t e M a t t e r v o l u m e ( m m 3 ) 0.1469 0 3 6 9 12 1150 1200 1250 1300 1350 1400 Visit (months) L e f t P a r a h i p p o c a m p a l v o l u m e ( m m 3
Slide 15: Summary: XPro Phase I Trial in AD
x White matter microstructure degenerates with Alzheimer’s Disease x Neuroinflammation causes synaptic, axonal & myelin disruption/dysfunction x XPro 1mg/kg once a week by subcutaneous injection is x Safe and well tolerated x Reduced neuroinflammation by 46% (FW) x Improves axonal quality by 17% (AF
Slide 16: Phase 2 Trial in Mild AD with Biomarkers of Inflammation
INCLUSION ▪ 200 patients 2:1 randomization (134 XPro™ patients vs 66 placebo patients) ▪ 1mg/kg XPro™ once a week for 6 months or placebo ▪ Inclusion criteria Mild AD - CDR global: 0.5 or 1 MMSE>21 Two or more biomarkers of inflammation CRP>1.5 mg/L ESR>10 sec HgbA1c>6% ApoE4 positive END - POINTS ▪
Slide 17: Phase 2 Trial in MCI AD with Biomarker of Inflammation
INCLUSION ▪ 90 patients 1:1:1 randomization - 30 patients per group ▪ Placebo,1mg/kg pr 2mg/kg XPro™ once a week for 3 months ▪ Inclusion criteria MCI of probable AD CDR global rating of 0.5 E - Cog memory items mean >1.5 At least one APOE4 allele Amyloid positive END - POINTS ▪ Primary: EMACC* Inte
Slide 18: Selective Inhibitor of Soluble TNF
NON - Selective Selective DN TNF Decreases inflammation Y Y Increased risk of infection Y N Increased risk of cancer Y N Causes demyelination Y N Neuroprotective N Y Enhances neuroplasticity N Y The Benefits of INMB’s Selective vs. Non - Selective sTNF Inhibition Adapted from MacEwan et al 2002 18 f
Slide 19: How XPro Neutralizes sTNF
see Steed et al., Science , 301, 2003 Soluble TNF Function Eliminated No inflammatory signaling for AD 19 Nonglycosylated Protein Expressed in E. Coli DN - TNF Can Not Neutralize tmTNF receptors not blocked so tmTNF biology preserved HOW XPro™ NEUTRALIZES sTNF And importantly leaves tmTNF and TNF re
Slide 20: XPro Promotes Remyelination
EXACERBATED DEMYELINATION REMYELINATION ETANERCEPT Anti - inflammatory AND immunosuppressive DN - TNF Anti - inflammatory NOT immunosuppressive CUPRIZONE Model of Multiple Sclerosis NORMAL Cuprizone model of demyelination in mice: Prober 2017 https://inmunebio.com/index.php/en/science/xpro1595/refer
Slide 21: Off-the-Shelf NK Therapy in Oncology
Off - the - Shelf NK Therapy Producing memory like NK cells from Patient’s Own NK cells in Their Circulation (ie: in vivo) for Oncology 21
Slide 22: INKmune: State of the Art
22 INKmune: STATE OF THE ART On - going P hase I enrolling high - risk MDS patients in open label dose escalation trial INKmune for treatment of cancer Preclinical data. INKmune primes patients own NK cells Active against hematologic and solid tumors Functional in immunosuppressive hypoxic environme
Slide 23: MoA #2: INKmune Differentiates Resting NK to Memory-Like NK Cells
A MULTI - DIMENSIONAL “PSEUDOKINE” 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) r N K ( d a y 0 ) T p N K 0 5000 10000 15000 NKG2C M e F I r N K ( d a y 0 )
Slide 24: INKmune First in Human Trial: MDS/AML
24 in Oncology INKmune First in Human Trial – MDS/AML Day 73 data - First Patient treated with INKmune IV (subject #3) INKmune activates tumor killing NK cells INKmune induces memory - like NK cells with enhanced lysis of NK - sensitive (K562) and NK - resistant (RAJI) cells S c r e e n D a y 1 p r
Slide 25: MoA #1: INKmune Increases Avidity of NK Cell Binding to Tumor Cells
0 200 400 600 800 1000 0 20 40 60 80 100 SK-OV-3 (n=3) 5 min rForce (pN) % N K C e l l s B o u n d resting NK TpNK NK IL-2 NK-IL-15 Avidity of tumor cell binding by resting and primed NK cells 25 A MULTI - DIMENSIONAL “ PSEUDOKINE ” MoA #1 – INKmune™ Increases Avidity of NK Cell Binding to Tumor Cel
Slide 26: INKmune Phase 1 Study in High-Risk MDS
DESIGN Open - label dose escalation study of intravenous INKmune enrolling 9 patients INCLUSION Patients with MDS with excess blasts ENDPOINTS Primary: Evaluate the safety and tolerability of INKmune when given intravenously INKMUNE™ PHASE 1 STUDY Phase I Trial in High - Risk MDS in Oncology 26 FIRS
Slide 27: INKROC Phase I Trial in Ovarian Cancer
INKROC ™ PHASE 1 STUDY Phase I Trial in Relapsed Platinum - resistant/refractory/intolerant ovarian cancer in Oncology 27 Open label Phase I/II Single Dose INKmune IP (n=6 subjects) Enrolment timetable (max enrolment rate) 1 28 56 63 77 91 Subject 1 Enrolment Subject 2 Enrolment Subject 3 Enrolment
Slide 28: NK Competitive Landscape
THE VARIABLES ▪ Cytokines - single or multiple as a therapeutic or as part of cell therapy ▪ NK cell source – autologous, allogeneic, iPSC, cord blood ▪ Genetically engineered – CAR or cytokine ▪ Off - the - Shelf or patient specific manufacturing ▪ A unique, stable cell line, not an NK cell ▪ >180
Slide 29: Targeting Neuroinflammation for Treatment Resistant Depression
Targeting Neuroinflammation for TREATMENT RESISTANT DEPRESSION (TRD) for TRD 29
Slide 30: Treatment Resistant Depression: Frustrations of Psychiatric Drug Development
The Subset of People Who Have Failed At Least Two Anti Depressants 1 out of 3 MDD patients or 33% of the estimated 7M patients Economic toll: $64B/year Higher comorbidity Chronic course of MDD TNF biology in TRD POC studies with anti - TNF blood CRP predicts response Symptoms affected anhedonia, psy
Slide 31: TRD Is Driven by Inflammation
▪ 20 million adults have major depressive disorder (MDD) per year ▪ One third (~7 million patients) have Treatment Resistant Depression (TRD) 1 ▪ Cost of TRD is nearly $64 billion 2 Haroon et al., Psychoneuroendocrinology, 2018. Plasma TNF levels are increased in TRD patients THE PROBLEM MDD, TRD An
Slide 32: TNF Predicts TRD
Treatment Response (≥50 reduction in HAM - D - 17 at any point during treatment) Miller 2011 Anti - tnf Treatment Reduces Depressive Symptoms In Patients With Elevated Biomarkers of Inflammation Inflammation - associated deficits in reward circuitry mediate the relationship between CRP and anhedonia
Slide 33: Phase 2 TRD Trial
DESIGN Six - week double blind placebo - controlled study of Xpro™ 45 patients in Xpro™ at 1 mg/kg 45 patients in placebo control group Biomarkers of inflammation at 0, 2, 6 weeks INCLUSION Failed 2 courses of antidepressants C - reactive protein (CRP) levels >3 mg/L Anhedonia ENDPOINTS Primary: Imp
Slide 34: Contact Us
CONTACT US HARNESSING THE POWER OF THE INNATE IMMUNE SYSTEM INMB INmune Bio Inc. 980 N. Federal Hwy, Suite 110 Boca Raton, FL 33432 (858) 964 - 3720 www.inmunebio.com 34