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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: Our Mission
Our Mission We are developing a pipeline of next generation selective oral therapies aimed at offering patients with chronic inflammatory and autoimmune diseases new and clinically meaningful treatment options. 3. | ©immunic, inc. | Jun/11/2021 & Immunic
Slide 4: Development Pipeline
Development Pipeline 4 IMU-856 Gastrointestinal Diseases Intestinal Barrier Function Program | Indication Target Preclinical Phase 1 Phase 2 Phase 3 Imu-838 Multiple Sclerosis DHODH Ee ee ee Uleerative Colitis DHODH SSS SSS SSS! Crohn's Disease DHODH a Primary Sclerosing Cholangitis | DHODH —_——————
Slide 5: Blocking DHODH Leads to a Selective Effect on Overactivated Lymphocytes
Blocking DHODH Leads to a Selective Effect on Overactivated Lymphocytes Without Broader Immunosuppression Lymphocyte Activated Lymphocyte Insufficient C)\ Bee nw mee IMU-838 © Disease related © activation Metabolically silent Activation of pyrimidine DHODH Ret de novo synthesis important DHODH upreg
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Slide 7: The Global MS Drug Market is Crowded But Enormous
The Global MS Drug Market is Crowded But Enormous Total 2020 Sales in G7 Countries*: USD 23.24 Billion Oral MS Drugs Have Substantial Market Share* IMU-838 Aims at Significant Share of USD 10+ Billion Oral MS Drug Market* Injectables at imethyl Fumarate USD 5.01 bn + Sales numbers in G7 countries (U
Slide 8: Successful MS Therapy Requires Efficacy, Safety and Tolerability
Successful MS Therapy Requires Efficacy, Safety and Tolerability Lifelong Disease G Therapeutic Goal: ee Preventing Disability Worsening Ea Need to Do so Without = Lifelong disease requiring decades of therapy = ~2.8 million people affected worldwide (~1 million in the US)! = Typically diagnosed in
Slide 9: Existing First-Line and Oral MS Drugs Leave Much to be Desired
Existing First-Line and Oral MS Drugs Leave Much to be Desired aural Interferons Teriflunomide Poe Cladribine S1P Modulators Acetate Fumarate Oral? o > vf vf ff ff Relapse Reduction @ Q Q@ a a a Prevention of Disability Worsening ] to a (@) a of Tolerability ¥ ° Q Q Qo io) Safety ¥ vv @ 1s) ° e Abse
Slide 10: IMU-838 is Targeted to be the Easy-to-Use Drug for MS
IMU-838 is Targeted to be the Easy-to-Use Drug for MS IMU-838 is intended to be: = the first once-daily medication for MS patients with a well-balanced combination of a favorable safety and convenience profile with robust clinical activity Benefits for Patient Advantages for Neurologist = Noticeable
Slide 11: Strong IMU-838 Phase Data Supports Desired Product Target Profile
Strong IMU-838 Phase 2 Data Supports Desired Product Target Profile Strong Phase 2 Data Underlines Robust Efficacy With Neuroprotective Potential Phase 2 Data Also Confirms Best-in-Class Safety and Tolerability = Suppression of MRI lesions (p< 0.001): met primary and = Administration of IMU-838 was
Slide 12: Phase Data of IMU-838 in RRMS: Primary and Key Secondary Endpoints Met
Phase 2 Data of IMU-838 in RRMS: Primary and Key Secondary Endpoints Met, Showing Strong Efficacy Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Phase 2 Trial * Blinded main treatment period of 24 weeks * Extended treatment period of up to 9.5 years to observe long-term safety Key Stud
Slide 13: Phase Data of IMU-838 in RRMS: Demonstrated Robust Efficacy
Phase 2 Data of IMU-838 in RRMS: Demonstrated Robust Efficacy The Robust MRI Lesion Suppression of IMU-838 Compares Favorably to Other First-Line and Oral Base Medications Commercially Available in RRMS.* MRI Endpoint lesions lesions lesions lesions/scan lesions IMU-838 IMu-838 Gkitemea |main| SMO!
Slide 14: Phase Data of IMU-838 in RRMS: Positive Signals on Time to Relapse and Unconfirmed Disability
Phase 2 Data of IMU-838 in RRMS: Positive Signals on Time to Relapse and Unconfirmed Disability Proportion of Patients With Relapse up to Week 24 Proportion of Patients With Unconfirmed Disability Progression up to Week 24 percent Percent 7 50 45 25 2am 40 % 19.4% 35 18.3% os 23.2% a5 20 a5 11.8% 32
Slide 15: DHODH Provides Proven Mechanism for Neuroprotection
DHODH Provides Proven Mechanism for Neuroprotection Phase 2 Data of IMU-838 in RRMS Showed Evidence of Potential Neuroprotective Activity: Robust Decrease in Serum Neurofilament Light Chain (Biomarker for Axonal Damage)! Percent 20 10 -20 t -30 30 mg IMU-838 45 mg IMU-838 Placebo [1] Quantification
Slide 16: Phase Data of IMU-838 in RRMS: Low Discontinuation Rates
Phase 2 Data of IMU-838 in RRMS: Low Discontinuation Rates Eee Low Discontinuation Rates for IMU-838 Treated RRMS Patients, Considerably Lower Than Placebo, Indicate an Overall Encouraging Tolerance Profile While Providing a Sense of Efficacy to Patients.* IMu-838 IMu-838 Chita: | eimennitse| OTE! |
Slide 17: IMU-838: Attractive Pharmacokinetic, Safety and Tolerability Profile
IMU-838: Attractive Pharmacokinetic, Safety and Tolerability Profile Confirmed in Multiple Clinical Trials = Safety profile similar to placebo: no general safety = Drug exposure tested in more than 800 human signals observed in clinical trials so far subjects and patients to date = No increased rate
Slide 18: Phase Data of IMU-838 in RRMS: No Hepatotoxicity Signals
Phase 2 Data of IMU-838 in RRMS: No Hepatotoxicity Signals Hy’s Law Assessment for Drug-Induced Liver Injury 10 oor Hy’s Law Assessment (ALT) Absence of Hepatotoxicity Signals and Other Relevant Adverse Events Leading to Discontinuations Differentiates Against Other Available Oral RRMS Medications.
Slide 19: IMU-838's Safety Profile is Unique
IMU-838’s Safety Profile is Unique Teriflunomide!™ Re Cladribine'® | Fingolimod'! | siponimod | Ponesimod”™ | ozanimod!® Fumarate PML Risk ¢ ° @ ° @ ie} 1°) Increased Number of Infections ¢ eo @ ° @ o Vaccination Limitations Od f °® @ @ re) ie) Gastrointestinal Toxicities, Incl. Diarrhea e °e ¢ ¢ ¢
Slide 20: IMU-838: Already Viewed as Most Attractive DMT in Development
IMU-838: Already Viewed as Most Attractive DMT in Development GLOBAL INSIGHTS ids * roy An Independent) Thing Party, Study Analyzed How SPH ERI MS Patients Are Switching Therapies = Independent expert group, Spherix, asked real world treating physicians: —If current DMT is not successful for the pat
Slide 21: IMU-838: Full Prescription Coverage Achievable at Attractive Pricing Range
IMU-838: Full Prescription Coverage Achievable at Attractive Pricing Range gq Immunic Hired Third-Party Pricing Experts to Perform Landscape Analysis for IMU-838 Pricing Historically, differentiated innovator drugs have not experienced price impactseven when generics are approved for a related or si
Slide 22: IMU-838 in RRMS: Phase Planning Underway With Update Expected in Q3/2021
IMU-838 in RRMS: Phase 3 Planning Underway With Update Expected in Q3/2021 Development Goals: Achieve Market Approval and Confirm Product Differentiation Based on Safety, Tolerability, Efficacy and Neuroprotective Properties of IMU-838. 30 mg once daily dose of IMU-838 targeted for phase 3 developme
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Slide 24: IBD: Therapeutic Pyramid
IBD: Therapeutic Pyramid Selective IMU-8: Immunomodulators Moderate Traditional Immunomodulators Corticosteroids Severity of Disease Mild Budesonide Aminosalicylates, Antibiotics [a] Present Daniell, etal. Annals ofintamal medicine 1589;111 8: 641648 [2] Dayharsh, Gerald A, etal Gastroenterology 200
Slide 25: IMU-838: Key Strengths That Address Limitation of Existing Therapies in IBD
IMU-838: Key Strengths That Address Limitation of Existing Therapies in IBD TS No clinical evidence of increased rate of viral reactivations — in vitro data of direct antiviral effect Mode of action may provide a new treatment option for patients failing other therapies in IBD Small molecule with lo
Slide 26: ENTRANCE Study: Primary Efficacy Results
ENTRANCE Study: Primary Efficacy Results Number of Patients @y Non- ENTRANCE Study: a Partial Responders Responders (11.5%) = Study performed with active 6 38.5% (34.6%) moiety vidofludimus Total Response 20 BERG All patients flled two attempts to taper down steroids BEY Oven-label, dosing of 35 mg
Slide 27: CALDOSE-1: Clinical Phase in UC Ongoing
CALDOSE-1: Clinical Phase 2 in UC Ongoing NCT03341962 @ & QX\ Coordinating Investigator: Dr. Geert d’Haens (AMC Amsterdam) Active IND in the United States Overall Number of Patients: 240 Currently More Than 100 Active Sites in 14 Countries: USA, Western, Central and Eastern Europe IND: investigation
Slide 28: CALDOSE-1: Phase Trial Design in UC
CALDOSE-1: Phase 2 Trial Design in UC Placebo (n=60) > — Placebo (n=60) Optional 10 mg IMU-838 QD a ner ad (n=60) Patients with Open EIS symptomatic Suse ete ae > 10mg IMU-838QD period to 30mg IMU-838 QD at weeks Ules — (qed) GHD term safety: upto 9 years _+ 30mgIMU-838.QD 45 mg IMU-838 QD (n=60) we
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Slide 30: IMU-838: Broad-Spectrum Antiviral Activity Against Different Pathogenic Viruses
IMU-838: Broad-Spectrum Antiviral Activity Against Different Pathogenic Viruses Antiviral Activity With ECsg Values in Virus Mutations are Not Expected to Single Digit uM Range Have Any Impact on IMU-838’s Activity In general, viruses rely on the host cell’s infrastructure for Ds nucleotide supply %
Slide 31: IMU-838: Demonstrated Activity in Hospitalized Patients With Moderate COVID-19
IMU-838: Demonstrated Activity in Hospitalized Patients With Moderate COVID-19 Evidence of Clinical Activity of IMU-838 Shown on Multiple Secondary Endpoints = Prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 trial* = Clinically meaningful improvements in time to clinic
Slide 32: IMU-838: Further Development Potential in Primary Sclerosing Cholangitis (PSC)
IMU-838: Further Development Potential in wey Primary Sclerosing Cholangitis (PSC) Encouraging Results From Investigator- Sponsored Trial Conducted at Mayo Clinic The promising results regarding biochemical parameters and safety = Single-arm, open-label, exploratory phase 2 proof-of-concept : trial*
Slide 33: IMU-838: IP Position
IMU-838: IP Position IMU-838 is Protected by Several Layers of Patents: 33 | ©immunic, inc. | Jun/11/2021 Patent on the specific salt form and pharmaceutical composition of IMU-838, granted in the United States, Europe and other key markets — expires in 2031 New patent filed in 2017 on the dosing re
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Slide 35: Autoimmune Diseases and IMU-935
Autoimmune Diseases and IMU-935 . 2 : Unmet Need in Psoriasis Care IL-17 in Autoimmune Diseases * Autoimmune diseases are frequent diseases affecting millions of patients worldwide) = Th17/IL-17/RORyt axis is important in auto immunity related diseases") * Antibodies targeting this axis successfully
Slide 36: IMU-935 Efficiently Leads to Suppression of Disease Activity
IMU-935 Efficiently Leads to Suppression of Disease Activity While Maintaining Required Physiological Functions es sams, @ | The differentiation towards Th17 cells is inhibited by IMU-935 On) The production of IL-17A and ay 6) Cytokine a) rue | IL-17F is inhibited by IMU-935 Production ¢ ee IFN-y xo
Slide 37: IMU-935: Cytokine Inhibition in Low Nanomolar Range and Normal Thymocyte Maturation
IMU-935: Cytokine Inhibition in Low Nanomolar Range and Normal Thymocyte Maturation Inhibition of RORy (20 nM) and DHODH (240 nM) Leads to Synergistical Inhibition of Cytokines in Stimulated Human Lymphocytes IMU-935 Allows Normal Thymocyte Maturation From Double-Negative Towards Matured CD4+ Thymoc
Slide 38: IMU-935 Does Not Induce Thymocyte Apoptosis
IMU-935 Does Not Induce Thymocyte Apoptosis i In Contrast to IMU-935, Comparator Compounds Have a Negative Impact on Thymocyte Viability and Therefore Bear the Risk of Lymphoma. 120. % Thymocyte (relative to % viable cells in vehicle) gs ‘Sun, Zuoming. City of Hope, 2024, unpublished 38 | ©lmmunic,
Slide 39: IMU-935: Phase Study Performed in Australia
IMU-935: Phase 1 Study Performed in Australia Double-Blind, Placebo-Controlled Phase 1 Study Performed in Three Parts 39 | ©immunic, inc. | Jun/11/2021 Phase 1 study performed in three parts = Part A: Single ascending dose (SAD) study in healthy volunteers = Part B: 14-day multiple ascending dose (M
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Slide 41: IMU-856: Hypothesis of Therapeutic Approach
IMU-856: Hypothesis of Therapeutic Approach Strengthening the Bowel Barrier Function Leads to Compartmentalization of Microbiome and (2) Intestinal Immune System and Prevents Immune Stimulation That Drives Disease Processes Microbiota Immune System Or xX Focus on Immunosuppression Influencing the Mi
Slide 42: IMU-856: Phase Study Performed in Australia
IMU-856: Phase 1 Study Performed in Australia Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Performed in Three Parts Exclusive global rights to commercialization of IMU-856 in all countries obtained through option and licensing agreement with Daiichi Sankyo Phase 1 study includes patien
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Slide 44: Summary and Highlights
= ) Summary and Highlights Advanced and well-balanced pipeline: Additional clinical activity of IMU Three differentiated products in various phases of demonstrated in COVID-19 and PSC; favorable safety and tolerability profile confirmed clinical development Excellent phase 2 datain RRMS: Shares outs
Slide 45: Leadership Team
) Leadership Team Company is Led by an Experienced Management Team vA a} Daniel Vitt, Duane Duane Daniel Vitt, 5 PhD i Nash, MD, Nash, MD, PhD - =) JD, MBA ; JD, MBA Brecutive Executive Y Chairman ¥ Chairman Hella Tamar a Ew SB Kohlhof, Howson, ~~ oa 7 Ee CFA y [ cso y an i Manfred Inderpal Joerg Vi
Slide 46: Thank You!
Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 48 | ©immunic, inc. | Jun/11/2021 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
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Slide 48: IMU-838 Binds to DHODH and Inhibits DHODH
IMU-838 Binds to DHODH and Inhibits DHODH IMU-838 Binds Into the DHO and Ubiquinone Binding Pocket IMU-838 Exhibits High Species Selectivity, Most Potent on Human DHODH With ICsp of “160 nM Left: Gaumgarmer etal, J. Med. Chem, 206;49:1239:1267; Right: Immunie data DHODH: dihydreorotate dehydroger 48
Slide 49: IMU-838: A Selective, Safe and Efficacious DHODH Inhibitor
IMU-838: A Selective, Safe and Efficacious DHODH Inhibitor = Convenient to use: = Selective DHODH = Proven clinical = Clinical phase 2 = Broad potential once-daily oral inhibitor — no efficacy in multiple trial in relapsing- in indications such dosing kinase inhibition clinical trials remitting mult
Slide 50: IMU-838: Development History
IMU-838: Development History Tested in More Than 800 Individuals, to Date 41 LA Free Acid Form Developed by 4SC Initial clinical trials were done by 4SC with a free acid formulation of the active moiety videfludimus as an amorphous material. In total, 4SC’s clinical trial data encompasses more than
Slide 51: IMU-838 Specifically Targets Highly Metabolically Activated Immune Cells
IMU-838 Specifically Targets Highly Metabolically Activated Immune Cells — Reducing Dual IL-17F/IFNy High-Producers Hyperactive/High-Affinity Immune Cells are Specifically Dependent on DHODH High metabolic turnover in high-affinity T cells High amounts of nucleotides for mRNA synthesis (up to 100-fo
Slide 52: IMU-838 Provides a Less Inflammatory Environment
IMU-838 Provides a Less Inflammatory Environment Stopping a Pro-Inflammatory Environment —> Repression of pro-inflammatory cytokines > Induction of some important anti-inflammatory cytokines EMC: peripheralblood menoruclearcells; MLR: mixed lymphocyte reaction Kohihof et at, Poster UEGW 2018 52 | ©i
Slide 53: Current Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)
Current Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) Escalation Treatment Approach in RRMS Base Medications ‘Treatment-Naive Patients Low-to-Moderate Disease Activity = Interferons = Glatiramer acetate = Dimethyl fumarate = Teriflunomide High MS Activity on Treatment Consider risks of
Slide 54: MS Therapies: Current Shortcomings
MS Therapies: Current Shortcomings Infusions: natalizumab, anti-CD20s Orals: S1Ps, fumarates Injectables: IFN-B1 and glatiramer acetate = Uncomfortable administration = Pre-testing: blood tests; = Frequent infusions (natalizumab) = Side-effects: flu-like (IFNG1) _ ditstadose monitoring = Risk discus
Slide 55: MS Opportunity
MS Opportunity Aubagio® (Teriflunomide) is Currently the Only Approved DHODH Inhibitor for MS = Aubagio® is indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, RRMS, and active secondary progressive disease, in adults = The recommended dose of Aubagio® is 7
Slide 56: Role of Epstein-Barr Virus (EBV) During MS Progression
Role of Epstein-Barr Virus (EBV) During MS Progression!) = Environmental risk factors most consistently linked with MS are infection with EBV, deficiency in sun exposure and/or vitamin D, and smoking. = EBV persists usually asymptomatically in immune-competent and healthy individuals in memory B cel
Slide 57: IMU-838: Second Generation, Highly Selective DHODH Inhibitor
IMU-838: Second Generation, Highly Selective DHODH Inhibitor With Distinct Chemical Structure = Aubagio® hits off targets, e.g. protein kinases EGFR and teriflunomide (Aubagio®) Aurora Al2], leading to off-target toxicities!) = Aubagio® has a half-life of about 18 to 19 days in humans!**!; wash-out
Slide 58: Teriflunomide Has a Safety and Tolerability Profile Not Expected From Selective DHODH Inhibition
Teriflunomide Has a Safety and Tolerability Profile Not Expected From Selective DHODH Inhibition Mean lymphocyte counts” Aubagio® 7 mg Placebo 254 2 (n=1045) 32 2 2 Mee a Adverse Event a ff |= 7 Headache Bg ett es ce | Wats 0 hOB Nest toot a2 aie a ALT increased a | Diarrhea ‘G Boo ; BY as Alopecia
Slide 59: Off-Target Effects: Kinase Inhibition by Teriflunomide
Off-Target Effects: Kinase Inhibition by Teriflunomide Teriflunomide trough level Teriflunomide is not purely selective for DHODH, it also PIM inhibits kinases such as Aurora A PDGFR, Aurora A, FYN, LCK, JAK3, PIM and EGFR JAK3 SS > c 2 = Most common adverse tek Ll ee events of EGFR inhibitors: FYN
Slide 60: RRMS Meta-Analysis
RRMS Meta-Analysis Prediction of Relapse Reduction From MRI Activity 20 Tog RELeffect) log(MRleffect) — Data for present analysis — Data froma previous meta-analysis? 30 = Meta-analysis of 54 published trials for the treatment of relapsing-remitting multiple sclerosis@ = Allows a robust estimation o
Slide 61: Disability Effects for Oral DMTs: Early 2010s
Disability Effects for Oral DMTs: Early 2010s!) Dimethyl fumarate 240 mg bid Fingolimod 0.5 mg ad ‘Teriflunomide 14mg ad DEFINE ‘CONFIRM DEFINE+ CONFIRM FREEDOMS. FREEDOMS 11 ‘TEMSO TOWER TEMSO + TOWER (N=818)"Cold, _(N=722y"Fos, pooled N=B43(Kappos, _ N=713(Calabresi, (N=721)"O'Connor, ——(N=75B)"(C
Slide 62: EMPhASIS: Phase Study Overview in RRMS
EMPhASIS: Phase 2 Study Overview in RRMS NCT03846219 Included Patient Population: 5) RRMS With Relevant Disease Activity = Male or female ( 18 > age < 55) P Coordinating Investigator = RRMS diagnosis (Revised McDonald criteria 2017) = Evidence of disease activity based on relapse and MRI criteria =
Slide 63: EMPhASIS: Phase Trial Design in RRMS
EMPhASIS: Phase 2 Trial Design in RRMS | _ 300r45 mg 30 mg IMU-838 — EoMT 30 mg IMU-838 ad aes EoT 30 or 45 mg 45 mg IMU-838 — EoMT 45 mg IMU-838 nahn EoT Scr. BLMRI = or 45 mg exam. Placebo — EoMT 30mgIMU-838 — “ity Sage EoT 30 0145 mg 45 mg IMU-838 noneens EoT l | | | | | D-28 D-14 DO W24/EoMT Att
Slide 64: EMPhASIS: Subgroup Analysis CUA MRI Lesions
EMPhASIS: Subgroup Analysis CUA MRI Lesions 30 mg IMU-838 Forest Plot Nu RR cece Number of 64+ lesions at Gazing: he 72 023 00900 Number of Gd lesion at Bazine: >= 4 — e035 on7 070 mate rl sa 035 014s ter a 8 020014 080 age = 0 — so 028 014 oa Age:> 0 yeate — S088 053 te weight e519 ee 66 03801875 ‘
Slide 65: EMPhASIS: Cumulative Number of CUA MRI Lesions
EMPhASIS: Cumulative Number of CUA MRI Lesions Time Course CCumutive numberof CUA MRI sions Baseline Weeks Week 2 Week 18 Treatment youn — 30mpIMU-838. — 4SmpiMUS38 — —Photbo 30 mg IMU-838 | 45mg IMU-838| Placebo st Mal 1-65, n=66 1-67, formal n=6 n= n=2 Week26 Effect of IMU-838 on MRI lesion suppre
Slide 66: EMPhASIS: Relapse-Related Endpoints
EMPhASIS: Relapse-Related Endpoints Effect on Annualized Relapse Rate (ARR) Treatment Group Number of Relapses Adjusted Mean ARR 30 mg IMU-838 71 13: 0.39 45 mg IMU-838 69 16 0.48 Placebo 69 18 0.53 Number of confirmad relapse events in each treatment armwerena2 (30mg IMU-838), noé (48 mgIMU-£28) an
Slide 67: EMPhASIS: Treatment-Emergent Adverse Events
EMPhASIS: Treatment-Emergent Adverse Events Severity ITEAE by Severity 30 mg IMU-838 45 mg IMU-838 Placebo Total INumbero Numberof INumberof Numberof INumber of] Patients |P216""S/Numberof] Patients |P*UE"""|Numberof] Patients |P2U2""=|Numberoi] Patients |Paer' TEAE (Ns) | with TEAE ar (gg| TEAE(NA)
Slide 68: EMPhASIS: Overall Treatment Discontinuations
EMPhASIS: Overall Treatment Discontinuations a Randomized Patients N=210 alee Treatment Discontinuation Before Week 24 (All Dosed Patients Until End of Blinded Treatment) gard eonaans Placebo 7.2% 5/69 nel All IMU-838 43% 6/140 Ss 30 mg IMU-838 2.8% 2/71 ae e a 45 mg IMU-838 5.8% 4/69 Placebo 30 mg
Slide 69: EMPhASIS: Most Common Treatment-Emergent Adverse Events
EMPhASIS: Most Common Treatment-Emergent Adverse Events Adverse Events Present in More Than 1% of Study Population 30mg IMU-838 45 mg IMU-838 Placebo Total Number Number Number Number bisitel| ar PES fens] es Pe Abemecl| ge | SSeS cofteae| patients | 8" | ofrzac| patients | 8" | ofteac| patients | M
Slide 70: Previous COMPONENT Trial of Vidofludimus
Previous COMPONENT* Trial of Vidofludimus Incidence of Liver Events!) Liver Event Treatment-Emergent Adverse Vidofludimus 35 mg Placebo Events By Preferred Term n=122 n=119 Biliary Colic 0 (0.0%) 1 (0.8%) Hepatic Pain 0 (0.0%) 1 (0.8%) Hepatic Steatosis 0 (0.0%) 1 (0.8%) Hepatocellular Injury 1 (0.8
Slide 71: ENTRANCE: Steroid Tapering Scheme
ENTRANCE: Steroid Tapering Scheme Out of 26 patients evaluable for efficacy analysis the steroid dose ed entering the study was 6 patients on 40 mg/day (23%) 6 patients on 30 mg/day (23%) 14 patients on 20 mg/day (54%) +Vido Study aim: Disease control and remission maintenance transferred from predn
Slide 72: ENTRANCE: Steroid-Sparing
ENTRANCE: Steroid-Sparing Development of prednisolone intake over 12 weeks (mITT): Median Prednisolone Dose (mg/day) C 1 mg/day! Wi w2 w3 w4 ws we mar) * n 20 20 20 15 10 75 (20-40) | (20-30) | (20-20) | (15-15) | (10-20) | (7.5-20) 30 | 3 26.5 24.6 20 15 10.6 8.5 (#8.0) | (5.2) | 00) | 00) | 22) |
Slide 73: Ulcerative Colitis (UC) Drugs Treatment Effect in Clinical Remission Rate
Ulcerative Colitis (UC) Drugs Treatment Effect in Clinical Remission Rate (Mayo Score) Induction Phase Intravenous/Subcutaneous Agents Given the relatively ‘comparable “5-10% placebo ‘effect across UC studies, we note the fidelity of placebo- adjusted treatment effect ‘comparison siekrumab _vedoteum
Slide 74: IMU-838 in PSC: Phase Proof-of-Concept Study
IMU-838 in PSC: Phase 2 Proof-of-Concept Study NCT03722576 NA 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 almo
Slide 75: IMU-838 in PSC: Study Flow Chart and Study Population
IMU-838 in PSC: Study Flow Chart and Study Population Enrollment Lead-in dosing 15mg 1 week Treatment 30mg (6 months) & Patient benefit? ALP: alkaline phosphatase; ULNE upper limitof normal 7S | ©immunic, inc. | Jun/: = Study planned to enroll 30 patients = Study screened 27 patients —5 patients wer
Slide 76: Primary Objective: Change in Serum Alkaline Phosphatase in Adult Patients Diagnosed With PSC
Primary Objective: Change in Serum Alkaline Phosphatase in Adult Patients Diagnosed With PSC aes Positive Outcome Ba omer F q (9) 95% Cl Definition of Primary Objective ALP Reduction Patients who achieve a reduction of ALP at week 24 Between Baseline and Week 24 3/18 (16.7%) 3.6%, 41.4% = greater or
Slide 77: IMU-838 in PSC: Statistically Significant Reduction in Serum ALP
IMU-838 in PSC: 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 PE
Slide 78: 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
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Slide 80: IMU-935: Inhibition of Th17 Differentiation
IMU-935: Inhibition of Th17 Differentiation @=@) Th17 Differentiation— Murine Primary Thymocytes 50) NS is . 40 he 3 = 30 = OnM/DMSO = 20 oom, = cy = 30nM 10 ™ 300 nM 0 | i rr re ee ee) MES eae Concentration of inhibitor 2 (ni IMU-935 profoundly inhibited Th17 The ICs9 for Th17 differentiation of di
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