Immunic, Inc. · NASDAQ:IMUX
Immunic — Corporate Update (February 2021)
52 slides from Immunic's corporate update, Feb 18, 2021
Slide 1: Slide 1
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: IMU-838: Preparations for Broad Market Access
IMU-838: Preparations for Broad Market Access Safety database contains more than 800 individuals (healthy volunteers and several patient populations) Commercial-scale production in place; material from this production ready to be used in future clinical trials and potentially for expanded access sch
Slide 5: Slide 5
Slide 6: IMU-838: Triple Attack on COVID-19
IMU-838: Triple Attack on COVID-19 IMU-838 is an Advanced Clinical Oral Drug Candidate With a Favorable Pharmacokinetic, Safety and Tolerability Profile With More Than 800 Individuals Exposed to Date IMU-838 Attacks COVID-19 by Three Complementary Mechanisms: a Inhibition of virus replication by dep
Slide 7: IMU-838 Antiviral Activity Against SARS-CoV-2 and Other Viruses
IMU-838 Antiviral Activity Against SARS-CoV-2 and Other Viruses | ©immunic, inc. | Feb/18/2022 IMU-838 is active against SARS-CoV-2 IMU-838 has shown broad- spectrum antiviral activity against different pathogenic viruses with ECso values in single digit uM range HCV (ECsy 4.6 UM) rs * IMU-838 bs 3
Slide 8: Publication: Summary of Antiviral Effects of IMU-838
Publication: Summary of Antiviral Effects of IMU-838 viruses (mop) oven access Article IMU-838, a Developmental DHODH Inhibitor in Phase II for Autoimmune Disease, Shows Anti-SARS-CoV-2 and Broad-Spectrum Antiviral Efficacy In Vitro Friedrich Hahn 1, Christina Wangen 1, Sigrun Hage 1, Antonia Sophia
Slide 9: Summary of Rationale for IMU-838 in COVID-19
Summary of Rationale for IMU-838 in COVID-19 ES Triple mode of action: orally available DHODH inhibitor with both antiviral and anti-inflammatory effects plus activation of innate immune response aS Host-based mechanism: avoids dependence on specific viral proteins and, therefore, offers broad-spect
Slide 10: Anticipated Pharmacokinetic Profile 22.5 mg BID
Anticipated Pharmacokinetic Profile 22.5 mg BID 14-day Treatment in Phase 2 IMU-838 in COVID-19 Patients SARS-CoV-2 AS49-ACE2 a Proposed dosing eis i. regimen ensures a 4 that therapeutic 3° ECoo9 33 . levels of : * gL T= IMU-838 are ECsp om reached starting ° : o 123 4 5 6 7 8 9 1011 2 13 14 15 16
Slide 11: IMU-838: Host Cell Based Approach Active Against Different Virus Variants
IMU-838: Host Cell Based Approach Active Against Different Virus Variants IMU-838 was not yet tested against different mutant forms of SARS-CoV-2, but due to its host-based mechanism, mutations are not expected to have any impact on IMU-838’s activity. = Viruses in general rely on the host cells inf
Slide 12: Slide 12
Slide 13: CALVID-1: Study Flow Chart
CALVID-1: Study Flow Chart NCT04379271 d Treatment 14 Days Follow-up14 Days Safety Follow-up 32 Days 45 mg IMU-838 (22.5 mg BID) exam. Placebo D-1 DO D14 D28 D60 BID: bis in die=two times daily; D:day;EoS: end of study; Scr: screening; exam. examination; SFU: safety followup ‘Stratification for rand
Slide 14: CALVID-1: Inclusion Criteria
CALVID-1: Inclusion Criteria = Male or female patients at least 18 years old = Admitted to the hospital or other medical in-patient treatment facility for treatment of COVID-19 = SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) test in a nasopharyngeal, orop
Slide 15: WHO Nine-Category Ordinal Scale
= ) WHO Nine-Category Ordinal Scale WHO RED: Blueprint Novel Coronavirus COVID-18 Therapeutic Trial Sypopss [Internet] 2020. Available from: https: ww wha. irt/blueprinYprioriy-diseases/key-action/COVID-19 Treatment Trial Design_Master_Protoccl_synopsis Final 18022020 po 15 | ©immunic, Inc. | Feb/18
Slide 16: CALVID-1: Main Exclusion Criteria
CALVID-1: Main Exclusion Criteria NYHA: New York Heart Assocation; ICL: intensvecare unit 16 | ©lmmunic, Inc. Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring in the near foreseeable future History or presence of serious or acute heart dise
Slide 17: CALVID-1: Database Outline
CALVID-1: Database Outline Main Analysis (MA1) Includes Data From 204 Randomized Patients Full Analysis (FA1) Will Comprise Data From All 223 Randomized Patients = MAI was intended to provide decision point for further = Will contain data from all randomized patients including development safety fol
Slide 18: Slide 18
Slide 19: Study Recruitment
Study Recruitment a Screened N=234 Screen Failures N=11 i goks pen eons Population for Main Analysis Population for Final Analysis!) N=204 N=223 Randomized But Not Treated N=2 45 mg IMU-838 N=99 <2 Placebo N=103 er Regulatory approvals were received in: USA, Germany, Bulgaria, North Macedonia, Greec
Slide 20: Patient Demographics
Patient Demographics Planned Treatment Total 45 mg IMU-838. Placebo N % N % N % Female 48 48.5 43 4l7 91 45.0 Sex Male 51 51.5 60 58.3 114 55.0 Asian ) 0.0 1 1.0 1 0.5 x Black or African American 0 0.0 1 1.0 1 0.5 ace Other ) 0.0 1 1.0 1 0.5 White 99 100.0 100 97.1 199 98.5 Ethnicity Not Hispanic or
Slide 21: Presence of COVID-19 Risk Factors and Disease Markers
Presence of COVID-19 Risk Factors and Disease Markers Baseline Characteristics Risk Factor IMU-838 Placebo ‘Age >= 65 Years % 24.2 23.3 Body Mass Index [kg/m?] Mean (SD) 29.08 (5.34) 28.40 (4.55) Pre-Existing Cardiovascular Disease % 52.5 39.8 C- Reactive Protein [nmol/L] Mean (SD) 3.95 (3.84) 2.99
Slide 22: Selected Concomitant Medications
Selected Concomitant Medications Used as Standard of Care IMU-838 Placebo N % N % ieee S oy 96 ae Remdesivir 6 6.1 6 5.8 Lopinavir/Ritonavir 2 2.0 7 68 Favirapivir 1 1.0 Co) 0 Darunavir 9 9.1 9 8.7 Lopinavir 0 0 1 1.0 Ritonavir 9 9.1 9 8.7 Rimantidine 1 1.0 0 0 Tocilizumab 0 0 1 1.0 Total n=202, MU-
Slide 23: Slide 23
Slide 24: Primary Endpoint
Primary Endpoint Proportion of Patients Without Any Need for Invasive Ventilation Through Day 28 = The sample size of the trial was determined based on early reports indicating a high need for invasive ventilation in hospitalized COVID-19 patients: — Shortage of ventilator units and other medical re
Slide 25: Key Secondary Endpoints
Key Secondary Endpoints 28-Day Mortality, Survival Without Respiratory Failure, and ICU Admission = The trial was also designed to investigate IMU-838's ability to reduce the probability of major complications for COVID-19 patients, such as 28-day mortality, survival without respiratory failure, as
Slide 26: Proportion of Patients with Clinical Recovery
Proportion of Patients with Clinical Recovery IMU-838 Increases the Number of Patients Achieving Clinical Recovery Proportion of Patients With Clinical Recovery (Based on Symptoms Body Temperature, IMU-838 Placebo Respiratory Frequency and Blood Oxygenation) N % N % Day7 15 18.5 10 12.8 Day 28 57 71
Slide 27: Time to Clinical Recovery / Symptom Resolution
Time to Clinical Recovery / Symptom Resolution Results of Other Medications Tested in COVID-19 Patients Casirivimab-Imdevimab!] Figure 4: Time to Symptom Improvement (mF AS) Prperion of Paes with npeorement Dips om de The median time to first day of symptom resolution was 14 days for casirivimab and
Slide 28: Time to Clinical Improvement
Time to Clinical Improvement IMU-838 Shows Acceleration of Time to Clinical Improvement Duration of Hospitalization (FAS): = Median: 14.0 days 1.00 = Third patient quartile!) — 16.0 days for IMU-838 — 19.4 days for Placebo Note: The endpoint time to clinical improvement is largely driven by hospital
Slide 29: Time to Clinical Improvement
Time to Clinical Improvement IMU-838 Shows Acceleration of Time to Clinical Improvement MFAS Population) ren | wee | ream | aes” (Centrally Calculated) | (P2¥S) (Days) wee 50% 13.9 13.9 0.0 75% 15.0 17.9 29 90% 18.9 26.8 79 Probability of clinical improvement 10 15 20 25 30 Days MPlacebo mIMU-838 Cl
Slide 30: Time to Clinical Improvement
Time to Clinical Improvement Results of Other Medications Tested in COVID-19 Remdesivir“ Lopinavir—Ritonavir21 10 — Remdesivir 10. 09-4 — Control é 2 9. & og] Hazard ratio 1-23 (95% C1087-175); 2 Lopinavir-ritonavir = 7] loa-rankp=0-24 z 08 § 07 - & § 07 : ie Covel 2 3 E 3 os é E 02 * 01 o 4 8 2 6 2
Slide 31: Time to Clinical Improvement (High-Risk Patients)
Time to Clinical Improvement (High-Risk Patients) IMU-838 Provides Patients with High-Risk Factors With Higher Improvements Probability of Clinical Patients F , : Elderly Patients Improvement All Patients With Presence Aged > 65 Years (Centrally calculated) of High-Risk Factors" ~ Difference Differe
Slide 32: Time to Clinical Improvement
Time to Clinical Improvement Kaplan Meier Assessment of High-Risk Population 4.00. 075 0.50. 025. Probability of having no clinical improvement 0.00. 0 2 4 6 8 10 12 14 18 8 20 2 24 28 28 30 Time to clinical improvement (days) Planned treatment 45 mg IMU-838 Placebo Mose ul arly xt (FA) ll pater (no
Slide 33: Time to Clinical Improvement (Early Treatment Start)
Time to Clinical Improvement (Early Treatment Start) IMU-838 Provides Better Improvements When Used Early Probability of Clinical Improvement Study Treatment Start Study Treatment Start (Centrally Calculated) <8 Days After First Symptoms > 8 Days After First Symptoms Differencein Differencein IMU-83
Slide 34: Proportion of Patients with Clinical Improvement (All Patients)
Proportion of Patients with Clinical Improvement (All Patients) IMU-838 Increases the Number of Patients Achieving Clinical Improvement Proportion of Patients With Improvement of WHO Nine-Category Ordinal Scale by at Least IMU-838 Placebo Two Points (Based on Investigator Assessment) N % N % Day 14
Slide 35: Proportion of Patients with Clinical Improvement (Elderly Patients)
Proportion of Patients with Clinical Improvement (Elderly Patients) IMU-838 Increases the Number of Elderly Patients (>65 Years) Achieving Clinical Improvement Proportion of Patients With Improvement of WHO Nine-Category Ordinal Scale by at Least IMU-838 Placebo Two Points (Based on Investigator Ass
Slide 36: Proportion of Patients with Clinical Improvement
Proportion of Patients with Clinical Improvement Results of Other Medications Tested in COVID-19 Patients Remdesivirl] Remdesivir group (n=158) _ Placebo group (n=78) Clinical improvement rates Day7 4(3%) 2 (3%) Day14 42 (27%) 18 (23%) Day 28 103 (65%) 45 (58%) Lopinavir—Ritonavir21 Lopinavir-Ritona
Slide 37: Time to Clinical Improvement
Time to Clinical Improvement Considering Antiviral Treatment 75% Probability of Clinical Improvement FAS Population (Days) (Centrally Calculated) IMU-838 Placebo No Combination With Antivirals (Monotherapy) 14.8 15.8 In Combination With Antivirals (Combination Therapy)" 14.8 15.7 Difference in Favor
Slide 38: Decrease of SARS-CoV-2 Viral Load
Decrease of SARS-CoV-2 Viral Load Day 14 Day 28 Absolute decrease of SARS-CoV-2 = viral load (calculated as viral load at Visit Day minus viral load at oy IMU-838 Baseline Visit) An anti-viral effect of IMU-838 on SARS-CoV-2 was observed as represented by viral titers at the end of the treatment per
Slide 39: Decrease of C-Reactive Protein (CRP)
Decrease of C-Reactive Protein (CRP) Systemic Inflammation Marker Strongly Associated with Patient Outcomes* TTTREEY & Info 8 2 4 aay An anti-inflammatory effect of IMU-838 was observed, based on a more effective reduction of C-reactive protein (CRP), a well-known marker for systemic inflammation in
Slide 40: Decrease of D-Dimer
Decrease of D-Dimer COVID-19 Prognostic Disease Marker Strongly Associated with Patient Outcomes* MIMU-838 ™ Placebo 0% -10% -15% 20% -25% -30% -35% in % of baseline 40% Day1 Day 6 Day14 Day 28 Amore effective reduction of D-dimer, a well-known prognostic disease marker for COVID-19, was observed in
Slide 41: Post Hoc Analysis on 'Long COVID' Symptoms
Post Hoc Analysis on ‘Long COVID’ Symptoms Initial Signal That IMU-838 May Contribute to Prevention of Long-Term Fatigue = Questionnaires from 36 patients were returned Proportion of Patients with Fatigue from investigators who participated in this trial at Study Completion at 3 clinical sites soo —
Slide 42: CALVID-1: Efficacy Summary
CALVID-1: Efficacy Summary * The rate of serious complications of moderate COVID-19 disease in hospitalized patients is very low: — Rates of <1% for invasive ventilation, <2% for 28-day mortality, and <1% of patients requiring an ICU stay — These low event rates prevented the primary and key seconda
Slide 43: Slide 43
Slide 44: Summary of the Overall Rate of Adverse Events
Summary of the Overall Rate of Adverse Events No General Safety Signals, as Compared to Placebo 45 mg IMU-838 Placebo Total Number | N°-°' | patients | Number | NO-9f | patients | number | NO-°' | patients of AEs ca Te | WithAE | of AEs Sah Te | WithAE | of AEs San ne | With AE (N#) (%) (N#) (%) (N#
Slide 45: Adverse Events of Increased Severity Related to COVID-19
Adverse Events of Increased Severity Related to COVID-19 Rate of Adverse Events Was Not Increased, as Compared to Placebo 45 mg IMU-838 Placebo Total Number Number Number Number of Patients | Number of Patients | Number of Patients of AEs | patients | with AE | of AEs | patients | with AE | of AEs |
Slide 46: Summary of Hematologic Adverse Events
Summary of Hematologic Adverse Events IMU-838 Did Not Intensify Any Hematological Effects, as Compared to Placebo 45 mg IMU-838 Placebo Total Number Number Number Number Patients | Number Patients | Number Patients of patients of patients of patients of AEs with AE of AEs with AE of AEs with AE with
Slide 47: Summary of Adverse Events of Infections
Summary of Adverse Events of Infections IMU-838 Did Not Increase the Rate of Infections and Infestations, as Compared to Placebo ‘45 mg IMU-838 Placebo Total Number of Patients | Number of ee Patients | Number of ee Patients Seger Organ Skee teetenediemn as (NA) | vn ae ny | MEPAE (8 | AEE INA) | ep
Slide 48: Summary of Hematologic Adverse Events
Summary of Hematologic Adverse Events IMU-838 Did Not Increase the Rate of Liver Events, as Compared to Placebo 45 mg IMU-838, Placebo Total Number Number Number Number Patients | Number Patients | Number Patients of patients of patients of patients of AEs with AE of AEs with AE of AEs with AE with
Slide 49: CALVID-1: Safety Summary
CALVID-1: Safety Summary = |MU-838 was found to be safe and well-tolerated in hospitalized patients with moderate COVID-19: — No general safety signals regarding new or more severe adverse events observed, as compared to placebo — Rate of serious adverse events and adverse events leading to treatmen
Slide 50: Slide 50
Slide 51: Activity on Clinical Endpoints in Hospitalized COVID-19 Patients
Activity on Clinical Endpoints in Hospitalized COVID-19 Patients IMU-838 Could Provide Moderate COVID-19 Patients a Safe and Convenient Oral Treatment Option IMU-838 showed evidence of clinical activity on multiple clinical endpoints in hospitalized patients with moderate COVID-19 | IMU-838 \ Treatm
Slide 52: Thank You!
Thank You! Immunic AG Immunic, Inc. Grafelfing (Munich) 1200 Avenue of the Americas Germany New York City, NY 10036 USA ts = Immunic Research GmbH === A Weinberg Campus Halle (Saale) Germany Immunic Australia Pty. Ltd. “Melbourne Australia 52 | ©immunic, inc. | Feb/18/2021