Inmune Bio Inc. · NASDAQ:INMB
Inmune Bio — Investor Presentation (September 2019)
38 slides from Inmune Bio's investor presentation, Sep 9, 2019
Slide 1: INMB non-confidential 3Q19
INMB non - confidential3Q19.v5
Slide 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 these terms and similar expres
Slide 3: A Next Generation immunology company
3 A Next Generation immunology company • Two product platforms targeting innate immune dysfunction • Programs in cancer, AD and NASH • Resistance to cancer immunotherapy in the TME • Neuroinflammation as a cause of neurodegenerative disease • Chronic inflammation as a cause of NASH • Platform techno
Slide 4: Financial Highlights
4 Financial Highlights • Nasdaq: INMB • Cash 6/30/19 $9.4 million • Debt $0 • Common Shares O/S 10.8 million Insider ownership: ~50% Notable Shareholder: Xencor (XNCR) XNCR licensing fee: Option to buy 10% of INMB for $10m at $100m valuation INMB non - confidential3Q19.v4
Slide 5: INmune Bio = Innate Immunity
5 INmune Bio = Innate Immunity Our Vision: Become the Leader in Reprograming the Innate Immune System for the Treatment of Diseases INMB non - confidential3Q19.v4
Slide 6: Company platforms therapeutic areas
6 1 company - 2 platforms - 3 therapeutic areas Pre - clinical Phase I POC Phase 2 INKmune MRD ovarian cancer INKmune high risk MDS INBXX oncology not disclosed #1 INBXX oncology not disclosed #2 INB03 MDSC/CPI INB03 trastuzumab resistance INB03 oncology not disclosed XPro1595 AD XPro1595 neuro orph
Slide 7: Market Opportunity: announced programs
Market Opportunity: announced programs 7 • XPro1595 - Alzheimer’s/dementia market* – 2019 est cost to care for US AD patients $280B • INKmune - Cancer residual disease market ** – 1,735,350 new cases and 609,640 people will die • INB03 - Resistance to Cancer Immunotherapy market*** – Cancer immunoth
Slide 8: DN-TNF Platform
DN - TNF Platform INMB non - confidential3Q19.v4
Slide 9: TNF – the "master" cytokine
INMB non - confidential3Q19.v4 TNF – the “master” cytokine 9
Slide 10: DN-TNF: novel inhibitor of soluble TNF
• 17 kDal mutated protein +10 kDal linear PEG • Identical to human TNF except for 6 amino acid substitutions • Once a week dosing by subQ injection INMB non - confidential3Q19.v4 Receptor binding, "DE loop" domain (subunit A) Receptor binding , "small" domain (subunit A) Mutation A145R Receptor bind
Slide 11: DN-TNF: how does it work
Active TNF + Inflammation Normal sTNF activity TNFR sTNF bind TNFR XPro1595 Active TNF + Inactive heterotrimers or NO Inflammation Heterotrimers cannot bind TNFR No sTNF activity DN - TNF: how does it work 11 INMB non - confidential3Q19.v4
Slide 12: How is DN-TNF Different?
12 How is DN - TNF Different? TNFR1 TNFR2 tmTNF (good) sTNF (bad) Normal TNF Biology 12 TNFR1 TNFR2 tmTNF (good) sTNF (bad) Approved TNF inhibitors X X TNFR1 TNFR2 tmTNF (good) sTNF (bad) DN - TNF X Prevent function of sTNF and tmTNF Neutralizes sTNF allowing normal of TM TNF INMB non - confidential
Slide 13: DN-TNF: Next Generation TNF inhibitor
13 DN - TNF: Next Generation TNF inhibitor Non - selective TNF inhibitor DN - TNF Decreases inflammation YES YES Increased risk of infection YES NO Increased risk of cancer YES NO Causes demyelination YES NO Neuroprotective NO YES Enhances neuroplasticity NO YES Differences: selective vs non - selec
Slide 14: INB03 for treatment of cancers resistance to immunotherapy
INB03 for treatment of cancers resistance to immunotherapy INMB non - confidential3Q19.v4
Slide 15: MDSC Predict Resistance to CPI
Stage IV Melanoma treated with Ipilimumab (Wolchok2016) MDSC Predict Resistance to CPI 15 (n=209 ) • INB03 targets MDSC • CPI + INB03 should overcome MDSC based resistance by eliminating MDSC so CPI become effective INMB non - confidential3Q19.v4
Slide 16: Targeting sTNF: fibrosarcoma model
INMB non - confidential3Q19.v4 0 2 4 6 8 10 12 14 16 ↓MDSC in tumor Decreased sTNF decreases differentiation and proliferation of MDSC 0 2 4 6 8 10 etanercept INB03 ↑CD8+ lymphocytes in tumor + tmTNF promotes NK/DC crosstalk that recruits CD+8 TILs 0 1 2 3 4 5 6 7 8 9 10 control INB03 ↑112 day survi
Slide 17: Preliminary data: INB03 Phase I
• Goals: 1. Determine safety 2. Determine Phase II dose 3. Demonstrate PD effect 4. Determine Phase II strategy • “Top - Line” Results 1. Safe and well tolerated 2. Phase II dose: 1mg/kg 3. Pharmacodynamic effect confirmed - ↓IL6 4. Planning Phase II study • 11 of 12 patients treated – Demographics
Slide 18: XPro1595 (for the treatment of Alzheimer's Disease/dementia)
XPro1595 (for the treatment of Alzheimer's Disease/dementia) INMB non - confidential3Q19.v4
Slide 19: AD: the problem
19 AD: the problem.. Nerve cell death Synaptic dysfunction Cognitive Decline INMB non - confidential3Q19.v4
Slide 20: XPro1595 for AD receives external validation
20 XPro1595 for AD receives external validation Alzheimer’s Association awards INmune Bio Part the Cloud Grant - $1M USD translational funding to study XPro1595 in Alzheimer's disease INMB non - confidential3Q19.v4
Slide 21: TNF: a validated target in AD
The good: targeting TNF decreases risk of AD INMB non - confidential3Q19.v4 21 TNF inhibitor Odds Ratio Cases Enbrel 0.31 21,280 Humira 0.35 20,130 Remicade 0.54 10,320 Adapted from Xu, Zhu and Gurney AAIC 2019 TNF: a validated target in AD The bad: ↑ risk of cancer, infection and MS when treated wi
Slide 22: XPro1595 AD Development Program
XPro1595 AD Development Program 18 patients in 3 cohorts • Weekly XPro1595 subQ for 3 months • Biomarkers of inflammation at 0, 6 and 12 weeks • Endpoints: – Safety – ↓ neuro - inflammation measured in: blood, cerebrospinal fluid, brain, breath and behavior – Measures of cognition, neuro - psychiatr
Slide 23: Immunologic biomarkers: AD
23 Immunologic biomarkers: AD MRI CSF Breath Blood Free Water content of white matter Volatile Organic Compounds Inflammation & Neurodegeneration Inflammation & Neurodegeneration Behavioral biomarkers of inflammation • Sleep disorders • Depression • Psychosis • Apathy • Aggression INMB non - confide
Slide 24: NeuLiv for NASH
NeuLiv for NASH INMB non - confidential3Q19.v4
Slide 25: Three Principles of INMB NASH program
25 Three Principles of INMB NASH program 1. Fibrosis is a highly conserved wound healing response and represents the final common pathway of virtually all chronic inflammatory injuries Prof. John Iresdale 2013 2. Chronic inflammation in the liver is caused by innate immune cells 3. Targeting chronic
Slide 26: Cycles of chronic inflammation in NASH
26 3 cycles of chronic inflammation in NASH Obesity Insulin Resistance Peripheral Inflammation Intestinal Inflammation Mesenteric fat Regional Inflammation lipotoxicity Innate immune activation Local Inflammation N A S H INMB non - confidential3Q19.v4
Slide 27: NAFLD: high fat/high fructose diet – 13 weeks
INMB non - confidential3Q19.v4 25 27 29 31 33 35 37 39 41 43 B a s e l i n e W e e k 1 W e e k 2 W e e k 3 W e e k 4 W e e k 5 W e e k 6 W e e k 7 W e e k 8 W e e k 9 W e e k 1 0 w e e k 1 1 w e e k 1 2 w e e k 1 3 B o d y W e i g h t ( g ) Control/Saline Control/XPro1595 HSHF/Saline HSHF/XPro1595 2
Slide 28: NAFLD: high fat/high fructose diet
NAFLD: high fat/high fructose diet – 13 weeks 28 Structurally similar to controls 20x • Decreased insulin resistance • Decreased hepatic steatosis • No change in total body weight INMB non - confidential3Q19.v4 Control NeuLiv adapted from Rodriguez/Tansey 2016
Slide 29: STAM model: NAFLD Activity Score and Fibrosis Score
INMB non - confidential3Q19.v4 STAM model: NAFLD Activity Score and Fibrosis Score 29 0 1 2 3 0 1 2 3 0 1 2 Control 2 4 1 - - - 1 6 3 3 1 NeuLiv 4 4 - - - - 5 3 8 - - hepatocyte ballooning lobular inflammation steatosis Control 4.4 ц 0.8 NeuLiv 2.9 ц 0.8 NAS (mean ц SD) Parameter (mean ц SD) Control
Slide 30: INKmune for the treatment cancer
INKmune for the treatment cancer INMB non - confidential3Q19.v4
Slide 31: INKmune Primed NK Cells Kill Cancer
INKmune Primed NK Cells Kill Cancer 31 rN Human ovarian cancer cells plus patient’s own NK cells cancer cell NK cell Human ovarian cancer cells with patient’s NK cells after INKmune treatment TpNK cancer cell INMB non - confidential3Q19.v4
Slide 32: INKmune: "universal" cancer therapy
INKmune: “universal” cancer therapy INKmune TpNK are active against many types of cancers: • Blood cancers: AML, MM, lymphoma • Solid tumors: breast, ovary, prostate, renal, lung 32 TpNK modified from Lowdell2007 and 2011 INMB non - confidential3Q19.v4
Slide 33: INKmune Development Program
INKmune Development Program Phase 1/2 study in relapsed/ refractory CaOva Platinum resistant/refractory patients with residual disease • Treatment: INKmune IP • Endpoints: – Safety – ↑ NK activation and tumor killing – ↓ tumor burden* Phase 1/2 dose - finding study in high - risk MDS † Patients with
Slide 34: INMB = Innate Immunity
INMB = Innate Immunity INMB non - confidential3Q19.v4
Slide 35: Milestones
Milestones 35 February 1, 2019 – IPO closed Feb19 – Part the Cloud award – Alzheimer’ Assoc 3Q19 – initial data on INB03 Phase I 4Q19 – first patient enrolled INKmune cancer trial 1H20 – initiate INB03 combination Phase II cancer trial 3Q19 – first patient enrolled XPro1595 AD trial 1H20 – initial d
Slide 36: Intellectual Property
Intellectual Property • 2021 – composition - of - matter (licensed from Xencor) • 2032 – Methods for treatment of neurologic disease • 2035 – use for treatment of cancer (licensed from University of Pittsburgh) • 2039 – use for treatment of NASH DN - TNF INKmune 36 • 2035 – use for treatment of canc
Slide 37: Experienced Leadership
Experienced Leadership 37 RJ Tesi, MD Chief Executive Officer & Chief Medical Officer Mark Lowdell, PhD Chief Scientific Officer David Moss Chief Financial Officer Management Board of Directors J. Kelly Ganjei CEO of Cognate Timothy Schroeder CEO and Founder of CTI David Szymkowski, PhD VP of Cell B
Slide 38: INMB: summary
38 INMB: summary • Public clinical stage immunology company • Two product platforms with multiple clinical programs • Efficient use of capital and funding sources to maximize run - way • Opportunity to add clinical programs as resources become available INMB non - confidential3Q19.v4