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Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 216 of the Securities
Slide 3: Development Pipeline
Development Pipeline IMU-856 Gastrointestinal Diseases Intestinal Barrier Function Program | Indication Target Preclinical Phase 1 Phase 2 Phase 3 Imu-838 Multiple Sclerosis DHODH —— Uleerative Colitis DHODH $ Crohn's Disease DHODH —_[—_ Primary Sclerosing Cholangitis | DHODH [UII LT LT) eee honein
Slide 4: PSC: Disease, Epidemiology and Commercial Context
PSC: Disease, Epidemiology and Commercial Context ch Rare Progressive Liver Disease With No Effective Treatment Currently Available WAS) Prevalence of PSC = Bile ducts in the liver become inflamed, narrow and prevent bile = Orphan indication with high unmet medical need from flowing properly = Appro
Slide 5: PSC: Novel Synergistic Approaches are Needed
“.anticholestatic treatments, however, are aimed to heal already injured biliary structures and do not address early immunological attacks as the cause of the disease. In the medium-term future, new treatments will have to be immunomodulatory.” Early immunogenic event > Toxic and inflammatory event
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Slide 7: Top-Line Data Now Available
7 Top-Line Data Now Available | ©immunic, inc. | Feb/18/2021 A | IMU-838 for the Treatment of PSC Investigator-sponsored trial supported by a grant from the National Institutes of Health (NIH) Immunic provided the study medication Performed under an investigator IND from the FDA held by the Principa
Slide 8: IMU-838 in PSC: Phase 2 Proof-of-Concept Study
IMU-838 in PSC: Phase 2 Proof-of-Concept Study wie Principal Investigator Investigator-Sponsored Trial Conducted at Two Mayo Clinic Sites Elizabeth Carey, MD (Mayo Clinic) Study Timelines = Study started in August 2019 = Enrollment took place between July 2019 and September 2020, but almost all enro
Slide 9: IMU-838 in PSC: Study Flow Chart
8 Enrollment Lead-in dosing 15mg 1 week Treatment 30mg (6 months) & Patient benefit? | ©immunic, inc. | Feb/18/2022 IMU-838 in PSC: Study Flow Chart Sd Inclusion Criteria Male or female subject aged 18 to 75 years Diagnosis of PSC consistent with the guidelines published by the AASLD. All subjects m
Slide 10: Study Population and Treatment Discontinuations
Study Population and Treatment Discontinuations = Study planned to enroll 30 patients = Study screened 27 PSC patients —5 patients were screen failures (4 patients did not have ALP elevated of at least 1.5 times ULN, and 1 patient had an excluded condition) —4 patients (in particular during the pand
Slide 11: Baseline Characteristics
‘SD: standard deviation; IOR: iterquartlerange; ALF: akaline phosphatase; PP:perprotocliIT:intanc-to-trast Baseline Characteristics PP population TT population (n=11) (n=18) Enrolled Site, n (%) Mayo Arizona: 3 (27.3%) 2 (50.0%) Mayo Rochester 8 (72.7%) 9 (50.0%) ‘Age at Enrollment Mean (SD) 48.1 (1
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Slide 13: Primary Objective: Change in Serum Alkaline Phosphatase
Primary Objective: Change in Serum Alkaline Phosphatase The Primary Objective Was to Determine Whether IMU-838 Reduces Serum ALP in Adult Patients Diagnosed With PSC Definition of the primary objective: postive Outcome 95% Cl = Patients who achieve a reduction of ALP Ns) at week 24 ALP Reduction >25
Slide 14: Study Results: Statistically Significant Reduction in Serum ALP
Study Results: Statistically Significant Reduction in Serum ALP Development for PSC IMU-838’s Reduction in Serum ALP Levels Compares Well to Other Medications in IMU-838 norUDCA"! OcaAnl Cilofexor!! ‘Administration Oral Oral Oral Oral Daily Dose 30mg QD 1500 mg QD 5 to 10mg QD (30 and) 100 mg QD PEC
Slide 15: Quantitative Change in Serum Alkaline Phosphatase
Quantitative Change in Serum Alkaline Phosphatase The Primary Objective Was to Determine Whether IMU-838 Reduces Serum ALP in Adult Patients Diagnosed With PSC = Time from baseline: calculated as continuous variable and treated as the primary predictor using a random intercept model which was Sees e
Slide 16: Individual ALP Changes Over Treatment Period
Individual ALP Changes Over Treatment Period ALP at three time points = Consistent individual pattern of a stable decrease in e004 Pasar ALP values between baseline and Week 24 (24-week = mutor treatment period) 2 = musa 3 penis = While the decrease in ALP values was moderate, no a = muro7 patient o
Slide 17: Example of Variability of Alkaline Phosphatase in PSC
Example of Variability of Alkaline Phosphatase in PSC Longitudinal Analysis of Vedolizumab in PSC-IBD Vedolizumab, n=102; median treatment duration, 412 days Almost half of the patients showed a decreased by more than 20% in only 20.6% of patients ALP drop by 2 20% n=21 (20.6%) 6004 © 4004 BO progre
Slide 18: Secondary Objective: Absence of Increase of Other Liver-Related Biochemical Parameters
Secondary Objective: Absence of Increase of Other Liver-Related Biochemical Parameters The Study Found That Other Liver-Related Biochemical Parameters Remained Stable Over the Treatment Period and No Signals for Worsening Were Observed Biochemical Parameter Baseline w2 wa ws wiz wie w20 w24 nT 78.5
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Slide 20: PSC and Ulcerative Colitis
PSC and Ulcerative Colitis Overlap and Differences in Epidemiology and Biology = Whereas PSC occurs in about 5% of patients with inflammatory bowel disease (IBD), approximately 70% of patients with PSC have IBD! = The gut-adherent microbiota in patients with PSC-IBD and IBD without PSC are significa
Slide 21: Ulcerative Colitis Clinical (UCC) Score
Ulcerative Colitis Clinical (UCC) Score Physician Assessment of Ulcerative Colitis Activity Scores Range From 0 to 12 Points, With Higher Scores Meaning Higher Colitis-Related Active Disease The UCC score, a modification and simplification of the well- known Mayo Score, UCC Score in Patients with PS
Slide 22: Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Patient-Reported Questionnaire for Health-Related Quality of Life Questionnaire Provides a Score Ranging From 10 (Lowest The SIBDQ consists of questions scored in Score) to 70 (Highest Score) four domains: = bowel symptoms, = emotional health, =
Slide 23: Summary of PSC-IBD Assessments
Summary of PSC-IBD Assessments Open-label trial using 30 mg IMU-838 once daily for 24 weeks in 5 patients with PSC-IBD comorbidity allows exploratory investigation of IBD disease assessments by physicians and patients Patient numbers are limited and several post-baseline data close to Week 24 are mi
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Slide 25: Study Results: Safety
Study Results: Safety IMU-838’s Favorable Safety and Tolerability Profile Was Confirmed in This Patient Population = SAE: There were no SAE or on-study deaths. = Treatment Emergent Adverse Events: —A total 36 AE were reported in 12 of the 18 patients that received any dose of IMU-838: —2 patients ha
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Slide 27: IMU-838 in PSC: Summary
IMU-838 in PSC: Summary Investigator-Sponsored Trial Performed at Mayo Clinic Encouraging Results Regarding Biochemical Parameters and Safety = Highly underserved patient population with only a small number of cases worldwide and no treatment option currently available = Feasibility study to explore
Slide 28: IMU-838 in PSC: Outlook
IMU-838 in PSC: Outlook As an Orally Available DHODH Inhibitor With a Prominent Influence on Th17 Induced Inflammatory Processes, IMU-838 is a Promising Approach for the Treatment of PSC The encouraging results regarding biochemical parameters and safety suggest that IMU-838 merits further clinical
Slide 29: Thank You!
Thank You! Immunic AG Immunic, Inc. Grafelfing (Munich) 1200 Avenue of the Americas Germany New York City, NY 10036 : , 4 USA £ <= __Immunic Research GmbH === A Weinberg Campus Halle (Saale) Germany Immunic Australia Pty. Ltd. “Melbourne Australia 29 | ©immunic, inc. | Feb/18/2021