Slide 1: Immunic Therapeutics: IMU-856 Phase 1 SAD/MAD Data in Healthy Human Subjects
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: Advanced Clinical Pipeline
Advanced Clinical Pipeline Three Differentiated Programs in Various Phases of Clinical Development = Completed or ongoing 3 Program | Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones RMS interim analysis planned after approx. half of the events occurred Vidofludimus PMS interim analysis pla
Slide 4: IMU-856: Phase 1 SAD/MAD Data in Healthy Human Subjects
IMU-856: Phase 1 SAD/MAD Data in Healthy Human Subjects Phase 1 Clinical Trial of IMU-856 = Trial Design and Study Population = Results Part A: Single Ascending Doses = Results Part B: Multiple Ascending Doses = Ongoing Part C in Patients with Celiac Disease (@)8)) Extended Information Section Summa
Slide 5: Trial Design and Status
Trial Design and Status Ongoing Part Cin Patients with Celiac Disease Results Part A: Single Ascending Doses Results Part B: Multiple Ascending Doses
Slide 6: Phase 1 Clinical Trial of IMU-856
Phase 1 Clinical Trial of IMU-856 01
Slide 7: Phase 1 Clinical Trial: Trial Design and Current Status
Phase 1 Clinical Trial: Trial Design and Current Status PART at Evaluation of single ascending doses (SAD) Healthy human subjects randomized to receive single dose of IMU-856 or placebo (ap: quaquedie=once-saiy; 7 | ©immunic, inc. 1 Sep/20/2022 PART pv Evaluation of multiple ascending doses (MAD) He
Slide 8: Phase 1 Clinical Trial of IMU-856
Phase 1 Clinical Trial of IMU-856 01
Slide 9: Dose Escalation Algorithm
Dose Escalation Algorithm Part A, Cohorts 1-6: Single Ascending Doses Cohat6 160mg IMU-856 ‘a or placebo (ratio 6:2) = Single oral tablet administration was performed. Cohats 120mg IMU-856 ‘ai or placebo (ratio 6:2) = Dosing in each cohort started with two sentinel participants: Cohat4 omg IMU-856 o
Slide 10: Dose-Linear Pharmacokinetics in Single Oral Dosing
Dose-Linear Pharmacokinetics in Single Oral Dosing Part A, Cohorts 1-6 = Rapid absorption after oral tablet administration with peak plasma concentration reached within 2 to 4 hours = Terminal plasma half-life of 16 to 20 hours well suited for once-daily dosing = Dose-proportional increase in plasma
Slide 11: Single Doses of IMU-856 Found to Have Favorable Safety and Tolerability
Single Doses of IMU-856 in Healthy Human Subjects Found to Have a Favorable Safety and Tolerability Profile Part A, Cohorts 1-6 11 | ©immunic, inc. | Sep/20/2022 1 | No serious adverse events No dose-dependency in adverse events No maximum tolerated dose reached No trends for post-dose changes in an
Slide 12: Conclusions: Part A Single Ascending Doses
Conclusions Part A: Single Ascending Doses = Single ascending oral doses of IMU-856 provided favorable pharmaceutical properties in Part A of this phase 1 clinical trial. = The favorable safety and tolerability profile allowed a smooth transition from Part A (SAD) to Part B (MAD) in healthy human su
Slide 13: Phase 1 Clinical Trial of IMU-856
Phase 1 Clinical Trial of IMU-856 01
Slide 14: Dose Escalation Algorithm
Dose Escalation Algorithm Part B, Cohorts 7, 7N-9N: Multiple Ascending Doses = Single daily oral tablet administration was performed over 14 Cohort 9N days. 160mg IMU-856 or placebo (ratio 6:2) Cohat 8N = Dosing in each cohort started with two sentinel participants: 80mg IMU-856 one randomized to IM
Slide 15: Dose-Linear Pharmacokinetics in Multiple Dosing (Day 1 and 14)
Dose-Linear Pharmacokinetics in Multiple Dosing (Day 1 and 14) Part B, Cohort 7N-9N 900 MEAN PLASMA CONCENTRATIONS OVER TIME BY TREATMENT PART 8 (LINEAR) 200 “e+ Cohort 7N- 40mg, Day1 Cohort 7N - 40mg, Day 14 700 s+ Cohort 8N- 80mg, Day1 —*—Cohort 8N - 80mg, Day 14 8 © Cohort 9N- 160mg, Day = Cohort
Slide 16: Pharmacokinetic Results (Trough Levels After Multiple Dosing)
Pharmacokinetic Results (Trough Levels After Multiple Dosing) Part B, Cohort 7N-9N 20 DAY 1 - DAY 14: Mean Plasma Trough Concentrations by treatment (linear). DAY 15 - DAY 17: Drop in plasma concentration over time post treatment Mean Plasma Concentration (ng/mL) 1 2 3 4 s 6 7 a 9 10 u 2 a “ Pe 16 ”
Slide 17: Overall Summary of TEAE, SAE and AE Severity
Overall Summary of TEAE, SAE and AE Severity Part B, Cohorts 7, 7N-9N Treatment Cohort7* | cohort7N | CohortsN | cohortsN | 4... Atay coe we | sat | me | aa | Ba | “os ‘Subjects with mild TEAEs, n (%) 1 (50%) 3 (60%) 3 (50%) 2 (33%) ‘9 (47%) 4 (57%) Subjects with moderate TEAEs, n (%) 1.(50%) 1 (20%
Slide 18: Most Common Treatment-Emergent Adverse Events
Most Common Treatment-Emergent Adverse Events Part B, Cohorts 7, 7N-9N Number (%) of subjects with TEAEs occurring in more than 2 subjects [Number of TEAEs reported] MedDRA Cohort 7* Cohort 7N Cohort8N Cohort 9N 7 Preferred Term aome | 40mg | 30mg | 260mg | ANE | Placebo (olnsesseIhy le (N=2) (N=5)
Slide 19: Most Common IMP-related Treatment-Emergent Adverse Events
Most Common IMP-related Treatment-Emergent Adverse Events Part B, Cohorts 7, 7N-9N Number (%) of subjects with IMP-related TEAEs occurring in 2 and more subjects [Number of TEAEs reported] MedDRA Cohort 7* Cohort 7N Cohort 8N Cohort 9N Acti Beebe PreferredTerm 40mg 40mg 80 mg 160 mg NS) fee a8 (N=2)
Slide 20: Laboratory Parameters: No Change in Neutrophils Compared to Placebo
Laboratory Parameters: No Change in Neutrophils Compared to Placebo Part B, Cohorts 7, 7N-9N Laboratory Values Over Time Individual Laboratory Values Hematology - Neutrophils Hematology - Neutrophils Neutrophils Absolute (10**9/L) ame crmc tomate see ere estates Mean time response curves +/- standar
Slide 21: Laboratory Parameters: No Hy's Law Range Cases Observed
Laboratory Parameters: No Hy’s Law Range Cases Observed Part B, Cohorts 7, 7N-9N Bilirubin vs. AST Showed No Evidence of DIL! Potential Bilirubin vs. ALT Showed No Evidence of DIL! Potential Hy’s Law Plot: BIL vs ALT across all post-dose visits Hy’s Law Plot: BIL vs AST across all post-dose visits S
Slide 22: Multiple Doses of IMU-856 Found to Have Favorable Safety and Tolerability
Multiple Doses of IMU-856 in Healthy Human Subjects Found to Have a Favorable Safety and Tolerability Profile Part B, Cohorts 7, 7N-9N No IMP-related serious adverse events No dose-dependency in adverse events No maximum tolerated dose reached No trends for post-dose changes in any laboratory parame
Slide 23: Conclusions: Part B 14-Day Multiple Ascending Doses
Conclusions Part B: 14-Day Multiple Ascending Doses = Daily oral doses of IMU-856 (up to 160 mg) demonstrated a favorable safety, tolerability and pharmacokinetic profile. = This allowed a smooth transition from Part B (MAD) to Part C (28-day dosing in patients with celiac disease) which is currentl
Slide 24: Phase 1 Clinical Trial of IMU-856
Phase 1 Clinical Trial of IMU-856 01
Slide 25: Celiac Disease is a Serious Autoimmune Disease
Celiac Disease is a Serious Autoimmune Disease Celiac disease is a multifactorial, complex autoimmune disease caused by an immune reaction against a degradation product of gluten and is strongly associated with specific HLA class Il gene variants (HLA-DQ2 and -DQg)!! * Gluten is degraded into gliadi
Slide 26: Celiac Disease Currently Has No Adequate Treatment Options
Celiac Disease Currently Has No Adequate Treatment Options How much is 10 mg of gluten? 10 mg of gluten is the total limit for all foods combined for the entire day. 26 | ©immunic, inc. | Sep/20/2022 The Only Option Today is a Gluten Free Diet!1] Symptomatic Patients Despite Gluten Free Diet = The o
Slide 27: Patients Across the Spectrum of Celiac Disease Need Access to a Drug Treatment
Patients Across the Spectrum of Celiac Disease Need Access to a Drug Treatment to Address Persistent Disease Activity Despite GFD Active Celiac Disease = Numerous, intense gastrointestinal symptoms = Marked by enterocyte atrophy * Antibody stimulation in (barrier fully compromised) response to glute
Slide 28: Phase 1 Clinical Trial of IMU-856: Part C in Celiac Disease Patients
Phase 1 Clinical Trial of IMU-856 Part C in Celiac Disease Patients Proot:of-Concept Study Flow Chart of Part C in Celiac Disease = Part C includes a well-controlled celiac disease patient population, designed to assess safety and tolerability of IMU-856 as well as pharmacokinetics and acute (serum
Slide 29: Summary and Outlook
Slide 30: IMU-856: Favorable Phase 1 Safety, Tolerability and Pharmacokinetic Profile
IMU-856: Favorable Phase 1 Safety, Tolerability and Pharmacokinetic Profile \ aii ~~ ® IMu-856 showed a favorable safety, tolerability and pharmacokinetic profile in this phase 1 clinical trial with no IMP- related serious adverse events seen in the SAD and MAD parts. = In particular, IMU-856 was sa
Slide 31: Outlook: Multiple Value Inflection Points Expected Across Three Clinical-Stage Programs
Outlook: Multiple Value Inflection Points Expected Across Immunic’s Three Clinical-Stage Programs m (IMU-838 = Interim data of phase 2 CALLIPER trial in PMS expected in H2/2023 and top-line data expected at the end of 2024 = Read-out of the first of the phase 3 ENSURE trials in RMS targeted for IMU-
Slide 32: Thank You!
Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 32 | ©immunic, inc. | Sep/20/2022 Immunic, Inc. 1200 Avenue of the Americas Immunic AG New York City, NY 10036 Gréfelfing (Munich) USA Germany Immunic Research GmbH Weinberg Campus Halle (Saale) Germany Imm
Slide 33: Extended Information Section: Part A – Single Ascending Doses
Slide 34: Most Common Treatment-Emergent Adverse Events
Most Common Treatment-Emergent Adverse Events Part A, Cohorts 1-6 Number (%) of subjects with TEAEs occurringin more than 2 subjects [Number of TEAEs reported] MedDRA Cohort1 | cohort2 | cohorts | cohorta | cohorts | Cohorte Single doses of Preferred Term 10 mg 20 mg 40 mg ‘omg 120mg | 160mg ane Fee
Slide 35: Most Common IMP-related Treatment-Emergent Adverse Events
Most Common IMP-related Treatment-Emergent Adverse Events Part A, Cohorts 1-6 Number (%6) of subjects with IMP-related TEAEs occurringin 2 and more subjects [Number of TEAEs reported] MedDRA Cohort 1 Cohort2 Cohort 3 Cohort4 Cohort5: Cohort 6 Acti Pieces PreferredTerm 10mg | 20mg | omg | somg | 320m
Slide 36: Summary of Safety and Tolerability Profile
Summary of Safety and Tolerability Profile Part A, Cohorts 1-6 Deaths, SAEs or study withdrawal due to TEAES None 76 TEAS in 31 participants n=73: mild n= 3: moderate (active treatment group) * Cohort 1 (10mg): Back pain — unrelatedto study treatment * Cohort 5 (120mg): Catheter site pain— unrelated
Slide 37: Extended Information Section: Part B – Multiple Ascending Doses
Slide 38: Demographics
Demographics Part B Treatment Cohort7 | Cohort7N | Cohort8N | Cohort9N | active ees 40 mg 40 mg 80 mg 160 mg (RB) a) (N=2) (N=5) (N=6) (N=6) Age (years), mean 38.5 35.0 30.5 27.3 31.5 34.6 Gender Male, n (%) 2(100%) | 3 (60%) 4(67%) 4(67%) | 13 (68%) | 4 (57%) Female, n (%) - 2 (40%) 2 (33%) 2 (33%)
Slide 39: Summary of Safety and Tolerability Profile
38 Summary of Safety and Tolerability Profile Part B, Cohorts 7, 7N-9N Deaths, SAEs or study withdrawal due to TEAES 1 Study Withdrawal due to 1 SAE unrelated to IMP (Staph. aureus bacteremia with myocarditis caused by an infected cannula with cellulitis) 84 TEAS in 20 participants 74: mild (in 13 s
Slide 40: Analysis of Laboratory Parameters
Analysis of Laboratory Parameters Part B = Laboratory values over time — Descriptive statistics showed no trend of values over time for any parameter = Individual changes — Shift tables showed no trend of individual changes beyond the normal range for any parameter = Individual clinically significan
Slide 41: Laboratory Parameters: Leukocytes
Laboratory Parameters: Leukocytes Part B, Cohorts 7, 7N-9N Laboratory Values Over Time Individual Laboratory Values Hematology - Leukocytes Hematology - Leukocytes Leukocytes (10449/L) Mean time response curves +/- standard deviation a7 Fd T ge K & = gs * 4 | 4 dy pa i a : 3 1 [s Dipre 2 os 07 mss m
Slide 42: Laboratory Parameters: Erythrocytes
Laboratory Parameters: Erythrocytes Part B, Cohorts 7, 7N-9N roy Laboratory Values Over Time ==a) Individual Laboratory Values Hematology - Erythrocytes Hematology - Erythrocytes Erythrocytes (10*412/L) Mean time response curves #/- standard deviation 60 55 2 = g 50 T & Hd a 45 7 . “ 1 a Is L i : *
Slide 43: Laboratory Parameters: Platelets
Laboratory Parameters: Platelets Part B, Cohorts 7, 7N-9N Individual Laboratory Values roy Laboratory Values Over Time Hematology - Platelets Hematology - Platelets Platelets (10*A9/L) Mean time response curves +/- standard deviation 300 a 250 = = at 3 pi Bia | Comes 0 a & z I 200 | ‘so os iE Die «O
Slide 44: Laboratory Parameters: ALT
Laboratory Parameters: ALT Part B, Cohorts 7, 7N-9N roy Laboratory Values Over Time Biochemistry - ALT Alanine Aminotransferase (U/L) wae rte sag sare Mean time response curves +/- standard deviation «(7 T Individual Laboratory Values Biochemistry - ALT Alanine Aminotransferase (U/L) 1 Dtpre 02 cy o
Slide 45: Laboratory Parameters: AST
Laboratory Parameters: AST Part B, Cohorts 7, 7N-9N Individual Laboratory Values roy Laboratory Values Over Time Biochemistry - AST Biochemistry - AST Aspartate Aminotransferase (U/L) er nan eee, a Mean time response curves +/- standard deviation * » 2 be Per ie én * ie a We . “ . af Aspartate Amino
Slide 46: Laboratory Parameters: Bilirubin
Laboratory Parameters: Bilirubin Part B, Cohorts 7, 7N-9N roy Laboratory Values Over Time Biochemistry - Bilirubin Individual Laboratory Values Biochemistry - Bilirubin someting Bilirubin (umol/L) "mses enema ane ba Mean ime response curves + standard deviation “ a0, » 7 Perey 25 ay iz sae 2 3 ‘ 5 d
Slide 47: Analysis of Vital Signs
Analysis of Vital Signs Part B = Vital signs over time — Descriptive statistics showed no trend of values over time for any parameter — No difference between active treatment and placebo group = Individual changes — Shift tables showed no trend of individual changes beyond the normal range for any p
Slide 48: Vital Signs: Pulse Rate
Vital Signs: Pulse Rate Part B, Cohorts 7, 7N-9N qa Vital Signs Over Time Pulse Rate Individual Vital Signs Pulse Rate Pulse Rate (beats/min) Mean time response curves +/- standard deviation oa | Tt he 2 : 5 i T ie | net j {7 tik \ lal i & a“ 1 INS TVA a i 1 TIAUNHENI ae DANII LY NAIL é Yt} | [TI rh
Slide 49: Vital Signs: Diastolic Blood Pressure
Vital Signs: Diastolic Blood Pressure Part B, Cohorts 7, 7N-9N qa Vital Signs Over Time Diastolic Blood Pressure Individual Vital Signs Diastolic Blood Pressure Diastolic Blood Pressure (mmHg) Rerontertementne 08 Eee ena Mean time response curves +/- standard deviation ” ” a : 2 4 E | § | 1) £7 a |
Slide 50: Vital Signs: Systolic Blood Pressure
Vital Signs: Systolic Blood Pressure Part B, Cohorts 7, 7N-9N qa Vital Signs Over Time Systolic Blood Pressure Individual Vital Signs Systolic Blood Pressure Systolic Blood Pressure(mmHg) emma Mean time response curves +/- standard deviation 130 T aa es Z 4 ae “ to pa ? sere = 120 v H 2 & 3 v0 3 3 a
Slide 51: Analysis of 12-Lead Electrocardiograms
Analysis of 12-Lead Electrocardiograms Part B = 12-lead ECG parameters over time — Descriptive statistics showed no trend of values over time for any parameter — No difference between active treatment and placebo group = Individual changes — Shift tables showed no trend of individual changes beyond
Slide 52: 12-Lead ECGs Over Time: PR Interval
roy 12-Lead ECGs Over Time 12-Lead Electrocardiograms: PR Interval Part B, Cohorts 7, 7N-9N Individual 12-Lead ECGs PR Interval PR Interval PR [msec] Mean time response curves #/- standard deviation 200 r 180 e z 7 £160 & 140 » 120 a ooo % % 4 % % % % % % i , 5%, %, %, °y, fag ay Hay Igy Mp Hy Hy 1s
Slide 53: 12-Lead Electrocardiograms: QRS Duration
12-Lead Electrocardiograms: QRS Duration Part B, Cohorts 7, 7N-9N toy 12-Lead ECGs Over Time Individual 12-Lead ECGs QRS Duration QRS Duration QRS [msec] orpaaengrerteeea oe omen ‘Mean time response curves +/- standard deviation oe ¥ o . i : ae 100 ere Tm) ose ° = ° o g Eo» ° . & 0 a o s je Es ie ge
Slide 54: 12-Lead Electrocardiograms: QTcF Interval
12-Lead Electrocardiograms: QTcF Interval Part B, Cohorts 7, 7N-9N Individual 12-Lead ECGs al 12-Lead ECGs Over Time QITcF Interval QITcF Interval QTCF [msec] Mean time response curves +/- standard deviation é QTeF [msec] Visit Treatment» IMU-856 * Placebo 54 | ©lmmunic, inc. | Sep/20/2022 ECG: elec
Slide 55: Extended Information Section: Part C – Evaluation of 28-Day Multiple Ascending Doses in Celiac Disease
Slide 56: Ongoing First-in-Human Study
Ongoing First-in-Human Study Part C: IMU-856 in Patients with Celiac Disease During Periods of GFD and Gluten Challenge GO Eligibility Criteria Key Objectives/Endpoints = Age 18 to 65 years (inclusive) = Primary: = Biopsy proven diagnosis of Celiac Disease for at least 12 — Safety and tolerability m
Slide 57: Phase 1 Clinical Trial of IMU-856: Part C in Celiac Disease Patients
Phase 1 Clinical Trial of IMU-856 Part C in Celiac Disease Patients Planned Planned Planned Sarid Cohort Participants Participants Participants ae eB Dosing Regimen Total IMU-856 Placebo Sie 10 18 12 6 80mg QD 28 days 11 24 16 8 160 mgQD 28 days Total 42 28 14 (aD: quaque de sonce-dy 57 | ©immunic,