Immunic, Inc. · NASDAQ:IMUX

Immunic — Technical Presentation (September 2020)

66 slides from Immunic's technical presentation, Sep 11, 2020

  1. Slide 1: Slide 1

  2. Slide 2: Cautionary Note Regarding Forward-Looking Statements

    Cautionary Note Regarding Forward-Looking Statements This presentation contains”forward-looking statements" that in volve substantial risksand uncertainties for purposes of the safe harbor within the meaning of Section 27Aof the Securities Act of 1933, asamended, and Section 21€ ofthe Securities Exc

  3. Slide 3: IMU-838: Potential New Base Therapy for RRMS

    IMU-838: Potential New Base Therapy for Relapsing-Remitting Multiple Sclerosis (RRMS) IMU-838: Made of Action EMPhASIS Trial: Efficacy 2 il EMPhASIS Trial: Study Overview Targeting Multiple Sclerosis EMPhASIS Trial: Safety 3 | @lmmunic, nc. | Sep/11/2020, & Immunic

  4. Slide 4: 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 st SS psc DHODH TT coviD-1s* DHODH See imu-935 Psoriasis RORyt OS Orphan Al Diseases RORyt k= £.#§|+#$=«C IMU-856 a Inte

  5. Slide 5: IMU-838: A Pipeline in a Pill

    IMU-838: A Pipeline in a Pill Broad Therapeutic Potential Driven by Medical Needs IMU-838 is Intended to be a selective once-daily medication for Relapsing-Remitting RRMS patients witha well-balanced combination of favorable safety Multiple Sclerasis and convenience profile with robust clinical acti

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  7. Slide 7: IMU-838 Binds to DHODH and Inhibits DHODH

    IMU-838 Binds to DHODH and Inhibits DHODH IMU-838 binds into the DHO and Ubiquinane IMU-838 exhibits high species selectivity, most WA binding pocket potent on human DHODH with IC50 of ~160 nM DHODH Inhibition 3 omuers “Hal numa monkey fret at deg amity mouse 7 | ©immunic, inc. | Sep/11/2020 © Immun

  8. Slide 8: Mode of Action: DHODH Targeting Leads to Metabolic Stress

    Mode of Action: DHODH Targeting Leads to Metabolic Stress in Metabolically Activated Cells Activated Lymphocyte Lymphocyte Insufficient pyrimidine "recycling “Stressed” Lymphocyte IMU-838 + © Disease related activation © Activation of pyrimidine de novo synthesis Metabolically silent DHODH not impor

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  10. Slide 10: The Global MS Drug Market was Billion USD in 2016

    The Global MS Drug Market was 22 Billion USD in 2016 = Global market of MS drugs was USD 22 billion in 2016") = Currently approved drugs include oral and injectable drugs - Early injectables - Interferons (e.g. Rebif®, Avonex®) - Glatiramer acetate - Oral drugs - Teriflunomide - Dimethyl fumarate 2.

  11. Slide 11: Treatment Compliance and Persistence are Important Considerations

    Treatment Compliance and Persistence are Important Considerations for MS Disease Course! Preclinical phase It + Relapsing-remitting phase ft tit t it Clinical disability MRI activity Secondary progressive phase Brain volume asia - i i lx? years >|<— 10-15 years —>|<—— 20 + years —> Life-Long Disease

  12. Slide 12: Current Treatment of RRMS

    Current Treatment of RRMS Escalation Treatment Approach in RRMS BaseMedications Escalation Treatments 2nd/3rd Line Treatments Treatment-naive Patients High disease activity Low-to-moderate disease activity = Interferons = Fingolimod = Glatiramer a = Siponimod acetate 3 2 * Natalizumab = Dimethyl 35

  13. Slide 13: MS Therapies: Current Shortcomings

    MS Therapies: Current Shortcomings Injectables: IFN-B1 and glatiramer acetate Orals: S1Ps, fumarates Infusions: natalizumab, anti-CD20s Uncomfortable administration Side-effects: flulike (IFNB1) and rash (glatiramer acetate) Modest anti-inflammatory effects Essentially no new-starts except for glati

  14. Slide 14: MS Therapies: Current List of Black Box Warnings and Risks

    MS Therapies: Current List of Black Box Warnings and Risks Drug Risk/ Warning Alemtuzumab (Lemtrada®) _| Autoimmunity, infusion reactions, and malignancies. Thyroid disorders Black box warning! Risk of progressive multifocal leukoencephalopathy (PML), only accessible through Natalizumab (Tysabri®) :

  15. Slide 15: Despite Many Therapies Approved, There Remains Ample Opportunity

    Despite Many Therapies Approved (and Nearing Approval) for Relapsing Forms of MS, There Remains Ample Opportunity fora ... Safe Oral Well-Tolerated Robust Anti-Inflammatory, with Neuroprotective Properties Beyond What Would be Expected by Reducing Inflammation.

  16. Slide 16: IMU-838 Positioned to be a New Safe and Efficacious Treatment Option

    IMU-838 Positioned to be a New Safe and Efficacious Treatment Option for Early RRMS Patients IMU-838 could provide RRMS patients with a distinctive combination of robust efficacy combined with favorable safety and tolerability due to uniquely blending of properties: Robust MRI lesion suppression of

  17. Slide 17: 1) Robust Efficacy

    1) Robust Efficacy The Robust MRI Lesion Suppression of IMU-838 Compares Favorably to Other First-Line and Oral Base Medications Commercially Available in RRMS.* IMu-838 IMu-838 @etihemie | eeitmenititse| 2mm Finpoliodala mecinenimod.! acetate!!! fumaratel?) Administration Oral Oral Injectable Oral

  18. Slide 18: 2) Low Discontinuation Rates

    2) Low Discontinuation Rates ==, 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 Gitte esinnennictse|| PMCS || stperaitinreTe || “tirertte

  19. Slide 19: Relevant Comparators

    Relevant Comparators First-Line and Oral Medications in RRMS 25% @ ® Siponimed © IMU-833 Dimethyl fumarate © Teriflunomide IMU-838 properties are matching well with current unmet medical need for early RRMS. 50% ¢ Fingolimod (oqace|g sa 9% ul) uorssesddng uoIse7 PyIAL 4 Glatiramer acetate 2% Higher

  20. Slide 20: 3) Absence of Hepatotoxicity Signals

    3) Absence of Hepatotoxicity Signals Absence of Hepatotoxicity Signals and Other Relevant Adverse Events Leading to Discontinuations Differentiates to Other Available Oral RRMS Medications. Hy’s Law Assessment (30mg IMU-838) Liver Enzyme Elevations jo Hyperbitinubinemia y's Law Range 30 ae mg mgs IM

  21. Slide 21: IMU-838: Target Profile in RRMS

    IMU-838: Target Profile in RRMS IMU-838 is Intended to be a Selective Once-Daily Medication for RRMS Patients With a Well- Balanced Combination of Favorable Safety and Convenience Profile with Robust Clinical Activity For Patient For Neurologist = Convenient safety profile of an oral drug without =

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  23. Slide 23: EMPhASIS: Phase 2 Study Overview in RRMS

    EMPhASIS: Phase 2 Study Overview in RRMS x Coordinating Investigator Robert Fox (Cleveland Clinic) Blinded Main Treatment Period ial Extended Treatment Period = Parallel group design with placebo control = Upto 9.5 years = Overall blinded treatment period of 24 weeks = Extension study to observe lon

  24. Slide 24: EMPhASIS: Phase 2 Study Overview in RRMS

    EMPhASIS: Phase 2 Study Overview in RRMS Included Patient Population: RRMS With Relevant Disease Activity Px Main Exclusion Criteria Male or female (18 2 age < 55) RRMS diagnosis (revised McDonald criteria 2017} Evidence of disease activity based on relapse (one relapse in last 12 months or two rela

  25. Slide 25: EMPhASIS: Phase 2 Trial Design in RRMS

    EMPhASIS: Phase 2 Trial Design in RRMS 30mgiMU-838 — EoMT ————— 30mgIMU-838 — 300r45 mgIMU-838°— — EoT. 45mgiMU-838 — EoMT ————— 45mgiMU-838 — 30o0r45 mgIMU-838° — _EoT Scr.exam. BL MRI Placebo = — EoMT 30mgiMU-838 — 300r45 mgIMU-838® —__ EoT. 45 mgiMU-838 — 300r45 mgIMU-838° — _EoT l | | | | | | D-

  26. Slide 26: EMPhASIS: Primary and Key Secondary Efficacy Endpoints

    EMPhASIS: Primary and Key Secondary Efficacy Endpoints All MRI Scans Were Assessed Centrally by an Independent MRI Reading Center Only Key Study Endpoints To evaluate the efficacy of IMU-838 as compared to placebo based Baseline Blinded Treatment onthe cumulative number of new combined unique active

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  28. Slide 28: Study Met Primary and Key Secondary Endpoints

    Study Met Primary and Key Secondary Endpoints High Statistical Significance and Robust Results Regarding Suppression of CUA MRI Lesions . Robust efficacy Suppression of pve demonstrated Analysis Set | IMU-838 | Placebo | CUAMRILesions : IMU-838vs.Placebo | (sided) for both investigated Endpoint | ve

  29. Slide 29: Subgroup Analysis CUA MRI Lesions 30mg IMU-838

    Subgroup Analysis CUA MRI Lesions 30mg IMU-838 Forest Plot 4 ome ice vce Mumbetot 6d ein at ase: — 2022 000 080 umber of 6G eens a Baseline >= 4 4 ce 0280x7070 inate —— e038 ones female a ce 020 on mucmayise — e020 01a om nae > 0 yee — 508s 0m ate wight 059 — co oss on ors Efficacy effects ‘aga osg

  30. Slide 30: MRI: Cumulative Number of CUA MRI Lesions

    MRI: Cumulative Number of CUA MRI Lesions Time Course Ccumativ number of CUA MRI sions ‘Baseine ‘Week § ‘Week 12 Week 18 Treatment goup = — 30mg IMUS38 — 45mgiMUS38 —— Placebo 30mg IMu-838 | asmgimu-s38 | Placebo lst MRI Nees Ne66 Nee? lat Mal Ne6 Nes Neo Week 24 Effect of IMU-838 on MRI lesion supp

  31. Slide 31: MRI: Cumulative Number of New Gd-Enhancing MRI Lesions

    MRI: Cumulative Number of New Gd-Enhancing MRI Lesions Time Course Ccumutive numberof new Ga lesions 6 4 1, 2 ° Baseline “Week 6 ‘Week 12 ‘Week 18 “Week 24 Treatment group — 30 mgiMU-638 —— 4SmgiMU-838 —— Placebo 30mg IMu-838 | asmgimu-s38 | Placebo lst MRI Nees Nees Nee? lat mal fa Nes fa ‘Thegraph

  32. Slide 32: Secondary Endpoints: New Gadolinium-Enhancing MRI Lesions

    Secondary Endpoints: New Gadolinium-Enhancing MRI Lesions Number of Patients Without Any Gadolinium MRI Lesions Over Entire 24-Week Treatment Period* Treatment Group Number of Patients Without Any Gadolinium MRI Lesions Over Entire 24-Week Treatment Period (N) (%) 30 mg IMU-838 42/71 59.2% 45 mg IMU

  33. Slide 33: Secondary Endpoints: Relapse-Related Endpoints

    Secondary Endpoints: Relapse-Related Endpoints Effect on Annualized Relapse Rate (ARR) Treatment Group N 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 af confirmed relapse evens in each treatment armovere N=? (30mgIMU-83), N= [4S mg

  34. Slide 34: Time to Relapse

    Time to Relapse Kaplan Meier Analysis 107m, Despite the study’s relatively o7s eee small sample size and short duration of Proportion of patients without relapse up to Week 24 oso Z blinded treatment (24 028 weeks), a positive signal pationts 68 or os oo 8 st 8 2 z 2 : ool 8 & & 2 3 3 3 % ; 3 on tim

  35. Slide 35: Unconfirmed Disability Progression Up to Week 24

    Unconfirmed Disability Progression Up to Week 24 Proportion of patients with unconfirmed EDSS progression Despite the to Week 24) i . ene (up to Week 24) study’s relatively 15.0% small sample 40.0% size and short 2% duration of — blinded 25.0% 23.1% 20.0% treatment (24 15.0% 11.8% 12.1% weeks), a id

  36. Slide 36: Expanded Disability Status Scale (EDSS)

    Expanded Disability Status Scale (EDSS) Change from Baseline to Week 24 Absolute change of EDSS from Baseline Despite the os study’s relatively 6s small sample ‘a size and short duration of 02 blinded 04 treatment (24 , ee weeks), a positive signal Baseline Week 12 Week 24 on EDSS was detected. O—30

  37. Slide 37: Neurofilament Light Chain in Serum

    Neurofilament Light Chain in Serum Biomarker for Axonal Damage € 2+ 3 Robust decrease 4 in serum s “| Se 46.5% neurofilament as ° light chain al a “75% provides Bo evidence of 3 | potential By | neuroprotective . | activity for ia : IMU-838. 30 mg IMU-838 45 mg IMU-838 Placebo Treatment group ‘Quant

  38. Slide 38: Patient Reported Outcome

    Patient Reported Outcome Treatment Satisfaction Questionnaire for Medication (TSQM) TSQM Patient Questionnaire at Week 24 100 Patients havea perception of increased effectiveness versus placebo and show high satisfaction with IMU-838 treatment. Effectiveness Side Effects Convenience Global Satisfact

  39. Slide 39: Conclusions Regarding Efficacy

    Conclusions Regarding Efficacy = Primary and keysecondary endpoints met with high statistical significance — Robust efficacy demonstrated for both investigated doses of IMU-838 = Data on suppression of MRI activity encouraging and compares favorably to other first-line and oral medications in RRMS —

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  41. Slide 41: IMU-838 is Safe and Well-Tolerated

    IMU-838 is Safe and Well-Tolerated 41 | ©immunic, inc. | Sep/11/2020 Administration of IMU-838 in this clinicaltrialwas observed to be well-tolerated, thereby also providing further evidence ofa favorable safety profile of IMU-838 in the RRMS patient population In gene fety profile is similar to pl:

  42. Slide 42: Overall Rate of Patients With Treatment Emergent Adverse Events

    Overall Rate of Patients With Treatment Emergent Adverse Events Treatment Group Number of TEAE eat alle 30 mg IMU-838 70 32/71 (45.1%) 45 mg IMU-838 59 28/69 (40.6%) Placebo 62 30/69 (43.5%) There were 3 patients with serious treatment-emergent adverse events (SAE) inthis trial: Placebo: Squamous ce

  43. Slide 43: Most Common Treatment-Emergent Adverse Events

    Most Common Treatment-Emergent Adverse Events Adverse Events Present in More Than 1% of Study Population 30 mg IMU-BS8 35 mg IMU-BSB Placebo Tos Temes Remi Tenses emer ruurnber| of [PEI umber) af | umber] of ||P] umber] at /Patlents of ene Patients | MY Jorteat| patents | Mt" | ceteat| patients |” [

  44. Slide 44: Treatment-Emergent Adverse Events: Infections and Infestations

    Treatment-Emergent Adverse Events: Infections and Infestations 30 mg IMU-838 45 mg IMU-838_ Placebo Total JTEAE of SOC: infections and |Num ber of| Patient: Number of| Patient: Number of| Patient: Number of] Patient: Inrestations — fuumberof| Patients |P22"*|umberof| Patients |P3t°R*Ivumberat] Patie

  45. Slide 45: Treatment-Emergent Adverse Events: Severity

    Treatment-Emergent Adverse Events: Severity ITEAE by Severity 30 mgIMU-838 45 mgIMU-838 Placebo Total Number of Number of Number of Number of Numberof] Patients |PE™S|Numberof] Patients |P'EI"S|Numberaf] Patients |") Numberof| Patients Pavers TEAE (Ni) With TEAE ee (y| TEAE (NA) | withTEAE Tree y| T

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  47. Slide 47: Overall Treatment Discontinuations

    Overall Treatment Discontinuations | Randomized Patients N=210 << Treatment Discontinuation Before Week 24 (all dosed patients until end of blinded treatment) i 9 ates Placebo 7.2% 5/69 Nel All IMU-838 43% 6/140 Ss 30 mg IMU-838 2.8% 2/71 ae e eS 45 mgIMU-838 5.8% 4/69 Placebo 30 mg IMU-838 45 mg IM

  48. Slide 48: Treatment Discontinuations due to Adverse Events

    Treatment Discontinuations due to Adverse Events Treatment Discontinuations Due to Adverse Hingaho some poe Events Before Week 24 Wee ee (N-69) (N-71) (N=69) Number of Patients Discontinued Treatment Related to Adverse Events lingcetertondecciontuertorsenontultiling ctucy NS NO. Nee stopping rules f

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  50. Slide 50: EMPHASIS Trial: Overall Rate of Liver Events

    EMPHASIS Trial: Overall Rate of Liver Events There Was No Increase in Liver Events for the Pooled IMU-838 Treatment Arms Versus Placebo During Blinded Treatment Period Treatment Group Rate of Patients With Treatment-Emergent Adverse Events (TEAE) With any TEAE fulfilling predefined criteria as liver

  51. Slide 51: EMPHASIS Trial: Liver Events

    EMPHASIS Trial: Liver Events Liver Enzyme Elevations Liver Enzyme Elevations 30 mg IMU-838 | 45 mg IMU-838 Placebo Number of Patients m1 69 69 Evaluated AIT or AST >5xULN 0 (0%) 1 (1.4%) 2 (2.9%) ALT or AST >10xULN 0 (0%) 1 (1.4%) 1 (1.4%) AIT or AST >15xULN 0 (0%) 0 (0%) 0 (0%) Liver enzyme elevati

  52. Slide 52: Liver Investigations

    Liver Investigations No Generalized Effect on ALT or Total Bilirubin 500-4 — 4504 2 aes 300 ° ° 204 @ 2504 ° 2 oe 2 E 204 154 0° 5 3° se & oo . ° 5 5 ° 086 ° z 1504 oe o s o° oo0 5 ° 104 3388 104 | 5 oe, 8 og ° pa “| deadde | badass A bes abedd a 46 30 mg IMU-836 45 mg IMU-836 Placebo 30 mg IMU-638

  53. Slide 53: Hy's Law Assessment for Drug-Induced Liver Injury

    Hy’s Law Assessment for Drug-Induced Liver Injury No Hy’s Law Cases for Either ALT or AST 10 Hvperbitibinemia laxuLn Hy’s Law Range 40 -| Hyperbitirubinemia laut Hy’s Law Range Peak BIL! [xULN] on oh get a oe : 6 re. ae. peti | t 3 ee “si Pee a 2 ames os eeeeetece | 3:|— a oe 7 S tom_,!s° | is a 5 c

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  55. Slide 55: Adverse Events of Interest

    Adverse Events of Interest 30 mgIMU-838 45 mgIMU-838 Placebo Total Number number] Number] Numbe of Patients of Patients of [Patients of Patients Nembetatients| with [NUMP=patients| with [UPC patients] with [NUMETbatients) with cay | with | TEAE [Pinay [with | TERE |TO| with | TERE [S| with | TEAE TE

  56. Slide 56: Hematology Analysis

    Hematology Analysis No Generalized Effect on Neutrophils Count 15.04 ° ° ms] 5 IMU-838 z se og treatment does § 1004 , 6 . ° 2 . not havea Fi oo . 8 oe 8 8 generalized 2 784 8 o § 8 oo]? a 6 ° effect on 3 50 hematology laboratory 254 values, as exemplified by 30mg Mu-836 45mg iMu-838 Placebo neutrop

  57. Slide 57: Slide 57

  58. Slide 58: Overall Rate of Renal Events

    Overall Rate of Renal Events There Was No Increase in Renal Events for the Pooled IMU-838 Treatment Arms Versus Placebo During Blinded Treatment Period Treatment Group Rate of Patients With Treatment-Emergent Adverse Events (TEAE) With any TEAE fulfilling predefined criteria as renal event IMU-838.

  59. Slide 59: Treatment-Emergent Adverse Events: Renal Events

    Treatment-Emergent Adverse Events: Renal Events Renal Events 30 mgIMU-838 45 mg IMU-638 Placebo Total Number Number Number Number Number] of |Patients|Number| of |Patients|Number| of |Patients|Number| of [Patients of TEAE|Patients| with |ofTEAE|Patients| with |ofTEAE|Patients| with |of TEAE|Patients

  60. Slide 60: Adverse Events of Special Interest

    Adverse Events of Special Interest pokes Event et) yeni 40 mg IMU-838 45 mg IMU-838 Placebo Total Interest Number Number Number Number Adverse events Number| of |Patients|Number| of |Patients|Number) of |Patients|Number| of [Patients f of TEAE|Patients| with |of TEAE|Patients| with |of TEAE|Patients

  61. Slide 61: Urine Sediment Analysis

    Urine Sediment Analysis No Generalized Effect Regarding Hematuria 100 4 oo ° ° ° 000 95 44 504 o 8 °° . cos There is no = 4-4 trend for a 34 hematuria (as = 0 measured in gs 26-4 ° °° ° i ss & ood urine sediment) 3 454 to be increased 104 oo° oo000 ° ° ° during IMU-838 ° 54 coecee co008 2o9cec0 of e

  62. Slide 62: Serum Uric Acid

    Serum Uric Acid No Generalized Change from Baseline Absolute change from Baseline of serum uric acid [mg/dL] 62 | ©lmmunic, inc. | Sep/11/2020 ° 3. 8 Fy ° ec 88 &= ° 8 30 mg IMU-838 45 mg IMU-838, Placebo Treatment group [visit Day 7 Mi Week6 B Week 12 B Week 18 B Week 24] There is no generalized ef

  63. Slide 63: Conclusions Regarding Safety

    Conclusions Regarding Safety Consistent with prior data sets in other patient populations, administration of IMU- 838 in this trial was observed to be well-tolerated — Providing further evidence of a favorable safety profile and replicating such safety profile in the RRMS patient population — Ingene

  64. Slide 64: IMU-838 Positioned to be a New Safe and Efficacious Treatment Option

    IMU-838 Positioned to be a New Safe and Efficacious Treatment Option for Early RRMS Patients IMU-838 could provide RRMS patients with a distinctive combination of robust efficacy combined with favorable safety and tolerability due to uniquely blending of properties: Robust MRI lesion suppression of

  65. Slide 65: Thank You!

    Thank You! Immunic AG Immunic, Ine. Gréfelfing near Munich 1200 Avenue of the Americas Germany fs New York City, NY 10036 USA f <=, Immunic Research GmbH === A weinberg Campus Hallle (Saale) Germany Immunic Australia Pty. Ltd. ‘Melbourne Australia 65 | ©lmmunic, inc. | Sep/11/2020

  66. Slide 66: Immunic, Inc.

    Immunic, Inc. 1200 Avenue of the Americas, Suite 200 New York, NY 10036, USA i) www.imux.com 66 | ©lmmunic, inc. | Sep/11/2020 Head of IR & Communications Phone: +49 89 2080 477 09 Email: ir@imux.com & Immunic

Immunic — Technical Presentation (September 2020) on 6ix