Immunic, Inc. · NASDAQ:IMUX
Immunic — Corporate Update (February 2021)
54 slides from Immunic's corporate update, Feb 18, 2021
Slide 1: Immunic Therapeutics Conference Call and Webcast
Immunic Therapeutics Conference Call and Webcast NASDAQ: IMUX | February 18, 2021
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 21E of the Securities
Slide 3: Development Pipeline
Development Pipeline Program Indication Target Preclinical Phase 1 Phase 2 Phase 3 IMU-838 Multiple Sclerosis DHODH Ulcerative Colitis DHODH Crohn’s Disease DHODH Investigator-Sponsored Trial Primary Sclerosing Cholangitis DHODH performed at Mayo Clinic / NIH COVID-19* DHODH IMU-935 Psoriasis ROR𝛄t
Slide 4: IMU-838 Fighting COVID-19: Leveraging DHODH's Broad-Spectrum Antiviral Activity
IMU-838 Fighting COVID-19 Leveraging DHODH’s Broad- Spectrum Antiviral Activity
Slide 5: IMU-838 Antiviral Activity Against SARS-CoV-2 and Other Viruses
IMU-838 Antiviral Activity Against SARS-CoV-2 and Other Viruses HCV (EC50 4.6 µM) IMU-838 IMU-838 is active hCMV against SARS-CoV-2 (EC50 7.4 µM) IMU-838 has shown broad- spectrum antiviral activity against different Arenavirus pathogenic viruses with (EC50 2.9 µM) EC50 values in single digit SARS-C
Slide 6: 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 cell‘s in
Slide 7: Study Background
CALVID-1 Trial of IMU-838 in Moderate COVID-19 Study Background
Slide 8: CALVID-1: Study Flow Chart
CALVID-1: Study Flow Chart NCT04379271 Screening Blinded Treatment 14 Days Follow-up14 Days Safety Follow-up 32 Days 45 mg IMU-838 (22.5 mg BID) R EoS SFU Scr. exam. Placebo D-1 D0 D14 D28 D60 Investigator’s choice of standard-of-care therapy BID: bis in die = two times daily; D: day; EoS: end of st
Slide 9: WHO Nine-Category Ordinal Scale
WHO Nine-Category Ordinal Scale 0 Uninfected, no clinical or virological evidence of infection 1 Ambulatory, no limitation of activities 2 Ambulatory, limitation of activities 3 Hospitalized – mild disease, no oxygen therapy 4 Hospitalized – mild disease, oxygen by mask or nasal prongs 5 Hospitalize
Slide 10: Baseline Characteristics
CALVID-1 Trial of IMU-838 in Moderate COVID-19 Baseline Characteristics
Slide 11: Study Recruitment
Study Recruitment Screened N=234 § Regulatory approvals were received in: USA, Germany, Bulgaria, North Macedonia, Greece, Hungary, Russia, Romania, Moldova, Bosnia and Screen Failures N=11 Herzegovina, and Ukraine § A total of 20 active study sites enrolled at least 1 patient § Of the 204 patients
Slide 12: 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/m²] 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 (3
Slide 13: Selected Concomitant Medications
Selected Concomitant Medications Used as Standard of Care IMU-838 Placebo N % N % Systemic Corticosteroids 65 65.7 66 64.1 (Including Dexamethasone) Remdesivir 6 6.1 6 5.8 Lopinavir/Ritonavir 2 2.0 7 6.8 Favirapivir 1 1.0 0 0 Darunavir 9 9.1 9 8.7 Lopinavir 0 0 1 1.0 Ritonavir 9 9.1 9 8.7 Rimantidin
Slide 14: Efficacy
CALVID-1 Trial of IMU-838 in Moderate COVID-19 Efficacy
Slide 15: 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 16: 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 17: 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 % Day 7 15 18.5 10 12.8 Day 28 57 7
Slide 18: Time to Clinical Improvement
Time to Clinical Improvement IMU-838 Shows Acceleration of Time to Clinical Improvement mFAS Population[1] Probability of clinical improvement 90% Difference in Probability of IMU-838 Placebo Favor of Clinical Improvement (Days) (Days) IMU-838 (Centrally Calculated) 75% (Days) 50% 13.9 13.9 0.0 50%
Slide 19: 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 Elderly Patients Improvement All Patients With Presence Aged ≥ 65 Years (Centrally calculated) of High-Risk Factors[1] Difference Difference Di
Slide 20: 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 Difference in Difference in IMU
Slide 21: 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 22: 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 23: Time to Clinical Improvement Considering Antiviral Treatment
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)[1] 14.8 15.7 Difference in Fav
Slide 24: Decrease of SARS-CoV-2 Viral Load
Decrease of SARS-CoV-2 Viral Load Day 14 Day 28 Absolute decrease of SARS-CoV-2 Placebo viral load (calculated as viral load at Visit Day minus viral load at Baseline Visit) IMU-838 An anti-viral effect of IMU-838 on SARS-CoV-2 was observed as represented by viral titers at the end of the treatment
Slide 25: Decrease of C-Reactive Protein (CRP)
Decrease of C-Reactive Protein (CRP) Systemic Inflammation Marker Strongly Associated with Patient Outcomes* IMU-838 Placebo 20 0 -20 in % from baseline -40 -60 -80 -100 1 2 3 4 5 6 7 day An anti-inflammatory effect of IMU-838 was observed, based on a more effective reduction of C-reactive protein (
Slide 26: Decrease of D-Dimer
Decrease of D-Dimer COVID-19 Prognostic Disease Marker Strongly Associated with Patient Outcomes* Day 1 Day 6 Day 14 Day 28 A more effective reduction of D-dimer, a well-known prognostic disease marker for COVID-19, was observed in IMU-838 treated patients, as compared to placebo. *D-dimer is common
Slide 27: 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 100%
Slide 28: 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 29: Safety
CALVID-1 Trial of IMU-838 in Moderate COVID-19 Safety
Slide 30: 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 No. of No. of No. of Number Patients Number Patients Number Patients patients patients patients of AEs with AE of AEs with AE of AEs with AE with AE with AE with AE (N#) (%) (N
Slide 31: 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 patients with AE
Slide 32: CALVID-1: Safety Summary
CALVID-1: Safety Summary § IMU-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 33: Conclusions and Outlook
CALVID-1 Trial of IMU-838 in Moderate COVID-19 Conclusions and Outlook
Slide 34: 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 IMU-838 1 endpoints in hospitalized patients with moderate COVID-19 Treatmen
Slide 35: IMU-838 in PSC: Investigator-Sponsored Trial Performed at Mayo Clinic
IMU-838 in Primary Sclerosing Cholangitis (PSC) Investigator-Sponsored Trial Performed at Mayo Clinic
Slide 36: IMU-838 for the Treatment of PSC
IMU-838 for the Treatment of PSC Top-Line Data Now Available 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 Principal Investigator As per agreement betwe
Slide 37: IMU-838 in PSC: Phase 2 Proof-of-Concept Study
IMU-838 in PSC: Phase 2 Proof-of-Concept Study Investigator-Sponsored Trial Conducted at Two Mayo Clinic Sites § Single-arm, open-label, exploratory study which planned to Principal Investigator enroll 30 patients, aged 18 to 75 years § Supported by National Institutes of Health (NIH) grant Elizabet
Slide 38: IMU-838 in PSC: Study Flow Chart and Study Population
IMU-838 in PSC: Study Flow Chart and Study Population Enrollment § Study planned to enroll 30 patients § Study screened 27 patients Lead-in dosing - 5 patients were screen failures (4 patients did not have 15 mg 1 week ALP elevated of at least 1.5 times ULN, and 1 patient had an excluded condition)
Slide 39: Baseline Characteristics
Baseline Characteristics PP population ITT population (n=11) (n=18) Enrolled Site, n (%) Mayo Arizona 3 (27.3%) 9 (50.0%) Mayo Rochester 8 (72.7%) 9 (50.0%) Age at Enrollment Mean (SD) 48.1 (16.7) 45.7 (15.2) Median (IQR) 41 (33, 66) 40 (32, 60) Range 26.0, 69.7 26.0, 69.7 Gender, n (%) Male 5 (45.5
Slide 40: IMU-838 in PSC: Efficacy
IMU-838 in Primary Sclerosing Cholangitis (PSC) Efficacy
Slide 41: 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: Positive Outcome 95% CI N (%) § Patients who achieve a reduction of ALP at week 24 ALP Reduction
Slide 42: Study Results: Statistically Significant Reduction in Serum ALP
Study Results: Statistically Significant Reduction in Serum ALP IMU-838’s Reduction in Serum ALP Levels Compares Well to Other Medications in Development for PSC IMU-838 norUDCA[1] OCA[1] Cilofexor[1] Administration Oral Oral Oral Oral Daily Dose 30 mg QD 1500 mg QD 5 to 10 mg QD (30 and) 100 mg QD
Slide 43: 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 Estimate of Change using a random intercept mod
Slide 44: Individual ALP Changes Over Treatment Period
Individual ALP Changes Over Treatment Period EoT* § Consistent individual pattern of a stable decrease in ALP values between baseline and Week 24 (24-week treatment period) § While the decrease in ALP values was moderate, no patient of the PP population showed an increase of more than 20% of ALP at
Slide 45: 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 progression by more than 20% in alkaline phosphatase Serum levels of alkaline phosphatase decreased by mo
Slide 46: Patients with Existing Comorbidity: IBD Assessments
IMU-838 in Primary Sclerosing Cholangitis (PSC) Patients with Existing Comorbidity: IBD Assessments
Slide 47: 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[1] § The gut-adherent microbiota in patients with PSC-IBD and IBD without PSC are signifi
Slide 48: 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 The UCC score, a Meaning Higher Colitis-Related Active Disease modification and simplification of the well- known Mayo Score, consists of four items: Highe
Slide 49: 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, H
Slide 50: IMU-838 in PSC: Safety
IMU-838 in Primary Sclerosing Cholangitis (PSC) Safety
Slide 51: 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
Slide 52: IMU-838 in PSC: Outlook
IMU-838 in Primary Sclerosing Cholangitis (PSC) Outlook
Slide 53: 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 54: Thank You!
Thank You! Immunic AG Immunic, Inc. Gräfelfing (Munich) 1200 Avenue of the Americas Germany New York City, NY 10036 USA Immunic Research GmbH Weinberg Campus Halle (Saale) Germany Immunic Australia Pty. Ltd. Melbourne Australia 54 | © Immunic, Inc. | Feb/18/2021