Immunic, Inc. · NASDAQ:IMUX
Immunic — IBD Innovate Conference: Product Development for Crohn's and Colitis (December 2019)
31 slides from Immunic's conference presentation, Dec 4, 2019
Slide 1: Immunic Therapeutics
Immunic Therapeutics NASDAQ: IMUX IBD Innovate Conference: Product Development for Crohn’s and Colitis December 4, 2019
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements + Certain statements contained in this presentation regarding matters that are not historical acts, are forward-looking statements within the meaning of Section 21£ of the Securities and Exchange Act of 1934, as amended, and the Private Securities
Slide 3: Company and Product Overview
Immunic THERAPEUTICS Company and Product Overview
Slide 4: Developing new orally available therapies for inflammatory and autoimmune diseases
e developing new a (5) = n-class or the treatment nflammatory and autoimmune diseases. £) Immunic Timers: | GEER
Slide 5: Development Pipeline
Development Pipeline Phase 1 Phase 2 Phase 3 IMU-838 Multiple Sclerosis DHODH LSE) Ulcerative Colitis }DHODH [| Crohn’s Disease ~DHODH Pst PSC DHODH ss ioyscine is IMU-935 Psoriasis RORyt || cto imusss ee —_— ee So ain Immunic © Immunic, nc. 03.12.2019 5
Slide 6: IMU-856: Concept
IMU-856 Concept
Slide 7: Barrier Function Hypothesis
Barrier Function Hypothesis: Bacterial Penetration Through Weakened Cellular Adhesion Causes Immune Overstimulation HEALTHYGUT _________, LEAKY GUT Xe Re ° . m ® ‘. gv O *%& ° Fe, to +e a -’ laa i TN COMPROMISED PESUED NUTRIENT Up SBN) (el ‘JUNCTION a, { Me reanceaie qpsiniinia GATTI wire nranis bby
Slide 8: Breakthrough Concept
IMU-856: Breakthrough Concept CONCEPT Restoring the intestinal barrierfunction t impairing the immune system “IMU-856 has the potential to revolutionize the way of treating multiple diseases related to intestinal barrier function” Immunic © Immunic, inc. 03.12.2019
Slide 9: Breakthrough Concept: IMU-856 Concept
IMU-856: Breakthrough Concept IMU-856 Concept '‘-—$——_. HEALTHYGUT _________, LEAKY GUT ¥ mn © Q . ) ey ° me ° -, TIGHT al m?* + m° SUNCTION 1 AN) Ad Ay Oi ‘by Dr Vincent Pecke for HAPPY GUT © Immunic, inc. 03.12.2019
Slide 10: IMU-856: Background
IMU-856 Background
Slide 11: Background
IMU-856: Background IMU-856 was discovered and developed by Daiichi Sankyo Venture Science Labs up to non-GLP safety stage Daiichi-Sankyo Novel target The target was identified in a knock-out animal model Immunic has an exclusive option for the global exclusive license to IMU-856 Immunic © Immunic,
Slide 12: IMU-856: Target
IMU-856 Target
Slide 13: IMU-856's Target: An Epigenetic Regulator
IMU-856’s Target: An Epigenetic Regulator... * ... influencing the tightly regulated network of genes and proteins associated with epithelial cell interaction/adhesion through its enzyme activities. NN Cellular functions Gene expression Protein function Target Protein activity © Immunic, inc. 03.12.
Slide 14: Target Expression and K.O. Model
Target Expression and K.O. Model * Target is predominantly expressed in intestinal epithelial cells (IECs) in intestinal crypts « Incolon and in small intestine Structure of mucosa in small intestine Villu; Colon Small intestine Sheding Cats Intestinal epithelial cells (IECs) * K.O. of target in IEC
Slide 15: IMU-856: Pharmacology
IMU-856 Pharmacology
Slide 16: Selectivity
IMU-856: Selectivity 120 a @ subT1 5 ® A SubT2 3 bes @ SubT3 = a © subT4 3 «(2 © Target 0 O subTs -20 -40 0.1 1 10 100 1000 nu I 56 inhibits the Target’s enzyme activity A unique bin ode allows high selectivity over other subtypes Immunic © Immunic, inc. 03.12.2019
Slide 17: Impact on Intestinal Permeability
IMU-856: Impact on Intestinal Permeability Intestinal permeability was measured _ || Cells seeded onto Start of assay as TEER’ after barrier-disrupting re (day 0) whco Rea values nestles the range of 1700 = 2000 stimulation in Caco-2 cells’ dayo day? day day 16 Maintenance Phase Transwell insert Roq
Slide 18: Impact on Barrier Function
IMU-856: Impact on Barrier Function “s iia 30 So No Sims IL-6 as | opens 2s “So sttssanar Dos tisea 3 ar Teopsinsero sat sph » Lee 7 Seops SHEDS S64 nt re ee “ime aer 18-2 Stiiion() M620 0 a 72 96 120 ee 68 ‘Tine fer IL-6 Stimlaon (8) sso. DS-1S60 (iM) paso s.1156 (80) Stimulus CINF-«) Stimulus (1-6
Slide 19: Pharmacology
IMU-856: Pharmacology In vitro cell-free In vitro cell Species differences In vivo IBD models Protein based test, ICs biomarker in HT-29 cells, ECsp Other proteins of same family 87 kinds of enzymes, receptors and channels Human / Mouse / Rat / Monkey (cell-free test, ICsq) Mouse DSS models (PAD*) 1
Slide 20: In-Vivo Activity
IMU-856: In-Vivo Activity Colitis Setting Duration Induction Immunic 1.5% DSS 1.5% DSS 3% DSS 1.5% DSS 2.8% DSS Treatment setting Induction 8 days Prevention Induction 6 days Prevention Chronic, 3 cycles (6+4days) Prevention recovery Chronic, 1 cycle (7+4 days) Prevention recovery Therapeutic 8 days
Slide 21: Activity
IMU-856: Activity Diarrhoea Score Raw data in Appendtr 1. Raw Data. Score = Vehicle = Sulfasalazine 60 moka = IMU-856 (SPIM-15) Imgikg Diarrhea Score [max. 4] Figure 3: Diarrhoea Score along the study. Diarrhoea scoring scheme: 0 = normal consiteny; 1 = sot; 2 = pasty, unshaped, not sticking to anus
Slide 22: IMU-856 Improves Colonic Histology
IMU-856 Improves Colonic Histology Colon histopathology Histology Score Architecture Score & 3 5 00258 4 ws oo, 2 S gs 2 o 6 2 oO. 1 0. 0 se RY o SS x s° we o& ef cS 3 se a we g e gf » oe s £ Immunic © Immunic, inc. 03.12.2019 22
Slide 23: No/Less Impact on Immune Cells
IMU-856: No/Less Impact on Immune Cells Infiltration Score ELISA - TNFa Colon z s 2 8 1 concentration TNFa [pg/mL] & |mmunic @immunic, inc. 03.12.2019
Slide 24: IMU-856: Safety
IMU-856 Safety
Slide 25: Preclinical Safety Assessment
IMU-856: Preclinical Safety Assessment * Safety package to initiate phase 1 clinical trial has been performed *« hERG, AMES, micronucleus (non-GLP) * 28 day subchronic toxicity studies in rats and monkeys « Respiratory, CNS, Cardiac safety ¢ Safety margin between efficacy in mice and NOAEL in rats i
Slide 26: IMU-856: Further Development
IMU-856 Further Development
Slide 27: Development Overview
IMU-856: Preclinical Package Immunic Development Overview SAD MAD Preparation Phase 1 Pharmaco- dynamic © Immunic, inc. 03.12.2019 27
Slide 28: Preliminary Development Plan
IMU-856: Preliminary Development Plan* Possible indications: CD an ; IBS-D and ICI colitis Phase 1 SAD: FPI H1 2020 Phase 1 MAD (14 days): FPIH1 2020 Phase 0: Validation of the Lactulose/mannitol test (ongoing) Phase 1b (14 days) POC: Phase 2: pharmacodynamic study Intended lead indication * Safety
Slide 29: Highlights
IMU-856: Highlights ... targets a yet undisclosed and novel target which modulates the intestinal barrier function. .. is an orally available, very selective and potent small molecule with beneficial safety and physicochemical properties. .. could be a disruptive treatment for several gut barrier as
Slide 30: Immunic: Australia, Melbourne
‘i AustraliaMelbourne smal est-in- ann selectivel B D Ow ug inhibitors ¢) OE roraTS reclinical. Qos DOD: GE o RORVtS SS. Etre yce: NASD NOSE QO 2s 23892 bowasbiotec =e — Eta? Bx s £26 ImMuUNICEe == “2823 Cohealthcare oF 33 “2s immunology = s'ye= moleculéae> | oe s§ sclerosis z DHODHIMU- 935PSC_ E in
Slide 31: Thank You!
Immunic THERAPEUTICS Thank You! Immunic, Inc. 1200 Ave of the Americas, Suite 200 New York, NY 10036 USA cso Phone: +49 176 17007935 Email: hella.kohlhof@immunic.de