Immunic, Inc. · NASDAQ:IMUX

Immunic — Technical Presentation (October 2023)

34 slides from Immunic's technical presentation, Oct 10, 2023

  1. Slide 1: Positive Interim Data of Vidofludimus Calcium in Progressive Multiple Sclerosis

    & Immunic . C ( ( ( THERAPEUTICS Positive Interim Data of Vidofludimus Calcium in Progressive Multiple Sclerosis Phase 2 CALLIPER Trial October 10, 2023

  2. 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 21€ of the Securities

  3. Slide 3: Disability Worsens Over Time in All Forms of MS

    Disability Worsens Over Time in All Forms of MS The Different Indications Have Different Paths and Drivers of the Disability Progression Relapsing Forms of MS (RMS) Progressive Forms of MS (PMS) | res | pee SEM Bonneuese pres = Relapses and MRI lesions dominate = Fewer relapses and lesions with = Re

  4. Slide 4: Phase 2 CALLIPER Trial Background Information

    i= Immunic THERAPEUTICS Phase 2 CALLIPER Trial Background Information

  5. Slide 5: CALLIPER: Ongoing Phase 2 Clinical Trial in Progressive MS

    CALLIPER: Ongoing Phase 2 Clinical Trial in Progressive Multiple Sclerosis (PMS) Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial* Screening Period Investigator: Robert J. Fox, M.D., Cleveland Clini Maximum 120 Weeks = 1Ceor = 467 patients enrolled at more than 70 sites in Nor

  6. Slide 6: Patient Demographics and Baseline Characteristics

    Patient Demographics and Baseline Characteristics Total Study Population of 467 Enrolled Patients Progressive Disease Subtypes Baseline Characteristics = Primary progressive MS = Non-active secondary progressive MS Active secondary progressive MS Total N=467 Disease ubtypeinformation are used as dia

  7. Slide 7: Interim Analysis of the Phase 2 CALLIPER Trial

    Interim Analysis of the Phase 2 CALLIPER Trial gq = Interim analysis for biomarkers serum neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), when approximately half of the enrolled subjects (225 patients) have completed 24 weeks of treatment Prospectively Planned Interim Bio

  8. Slide 8: Neurofilament Light Chain (NfL) Background Information

    i= Immunic THERAPEUTICS Neurofilament Light Chain (NfL) Background Information

  9. Slide 9: Neurofilaments Are Neuronal Proteins That Release Several Peptides Measurable in Blood

    Neurofilaments Are Neuronal Proteins That Release Several Peptides Measurable in Blood (Upon Neuronal Cell Death) First-generation and || Third-generation and second-generation Jf fourth-generation neurofilament assays J neurofilament assays Cross-Disease Neurologic Biomarker for Neurogenerative Dis

  10. Slide 10: PPMS Patients Treated with Ocrelizumab That Achieved Lower Levels of NfL Had Lower Risk

    PPMS Patients Treated with Ocrelizumab That Achieved Lower Levels of NfL Had a Lower Risk for Future Disability Ocrelizumab ORATORIO Study in PPMS as ORATORIO (OCR arm) 100%] DB: OCR >| OLE: ocr > Historical Comparison Years | Year 5| OLE baseline P=0.058 1 P=0.019 = Blood NfL levels re-baselined at

  11. Slide 11: Historical Comparison: Ocrelizumab Reduced Blood NfL Levels in ORATORIO

    Historical Comparison: Ocrelizumab, the Only Approved Drug for PPMS, Reduced Blood NfL Levels in the ORATORIO Study LQ! ORATORIO Showed a 12.4 % Delta for 24-Week ORATORIO Serum NfL Levels for Ocrelizumab Versus Placebo _ 120 a Ee = Blood NfL levels (geometric mean and 95% Cl, top) and relative = ch

  12. Slide 12: Neurofilament Light Chain (NfL) Interim Analysis

    i= Immunic THERAPEUTICS Neurofilament Light Chain (NfL) Interim Analysis of the Phase 2 CALLIPER Trial

  13. Slide 13: Improvements in Serum NfL for Vidofludimus Calcium Consistent Across Subtypes

    Improvements in Serum NfL for Vidofludimus Calcium Consistent Throughout the Overall PMS Population and All Subtypes Change to Week 24 as Compared to Placebo in % of Baseline 10% Overall PMS Population PPMS n-aSPMS aSPMS N=102 (IMU-838) N=32 (IMU-838) N=62 (IMU-838) N=3 (IMU-838) N=101 (Placebo) N=2

  14. Slide 14: NfL Reduction Compares Favorably with Other MS Therapies

    NfL Reduction Compares Favorably with Other MS Therapies CALLIPER Interim Data Compared to Select Historical Trials Vidofludimus Ocrelizumab Vidofludimus Siponimod _Vidofludimus _Siponimod Vidofludimus Ocrelizumab — Evobrutinib PPMS PPMS n-aSPMS n-aSPMS aSPMS aSPMS RRMS RMS RRMS (CALLIPER) (ORATORIO

  15. Slide 15: Improvements in Serum NfL in Patients With/Without Disease or MRI Activity

    Improvements in Serum NfL for Vidofludimus Calcium in Patients With/Without Disease or MRI Activity Change to Week 24 as Compared to Placebo in % of Baseline 10% Overall PMs Population aPMs n-aPMS amri n-aMRI N=102 (IMU-838) (mu-838) —_N=75 (IMU-838) N=26 (IMU-838) _N=76 (IIMU-838) N=101 (Placebo) (

  16. Slide 16: Vidofludimus Calcium Shows Lowering of NfL in Non-Active PMS

    Vidofludimus Calcium Shows Lowering of NfL at Week 24 in Patients with Non-Active PMS Disease (“Smoldering Disease”) | First-in-Class Nurr1 Activator, Targeting Improvement of Physical Ability of MS Patients Nurr1 Activator DHODH Inhibitor “° @ = Protecting neurons = Selective anti-inflammatory C- f

  17. Slide 17: Substantive Reduction of Serum NfL Levels Observed in CALLIPER

    Substantive Reduction of Serum NfL Levels Observed in CALLIPER Interim Analysis — Promising Signal for Study Readout NfL levels reduced by 22.4% versus placebo in vidofludimus calcium treatment arm i Reduction of NfL consistently shown across all subgroup analyses NfL effect observed in non-active S

  18. Slide 18: Glial Fibrillary Acidic Protein (GFAP)

    i= Immunic THERAPEUTICS Glial Fibrillary Acidic Protein (GFAP) Interim Analysis of the Phase 2 CALLIPER Trial

  19. Slide 19: Biology of Glial Fibrillary Acidic Protein (GFAP)

    Biology of Glial Fibrillary Acidic Protein (GFAP) 2s GFAP is a Non-Neuronal Biomarker ie Astrocyte Presumably Related to Diffuse Brain Disease = Astrocytes are the most numerous non-neuronal cells in the human central nervous system (CNS) — Provide cytoskeleton structure — Perform metabolic, structu

  20. Slide 20: Promising Early Signal for GFAP in the Overall PMS Population

    Promising Early Signal for GFAP in the Overall PMS Population Change in GFAP as Compared to Normalized Baseline Total Interim Analysis Population (24-Week Completer) 48-Week Completer Subpopulation N=102 (45 mg IMU-838), N=101 (Placebo) Ne4i (45 mg IMU-838], N=38 (Placebo) 25 15 2 p 2 £ 10 7.68 2 15

  21. Slide 21: Promising Signal for GFAP Observed in CALLIPER Interim Analysis

    Promising Signal for GFAP Observed in CALLIPER Interim Analysis Although early, interim GFAP data showed a promising initial signal Progression of GFAP response is generally thought to evolve more slowly and with lower amplitude than NfL Company believes that a longer follow-up may further strengthe

  22. Slide 22: Positive Interim Biomarker Data of Vidofludimus Calcium in PMS

    Positive Interim Biomarker Data of Vidofludimus Calcium in Progressive Multiple Sclerosis (PMS) Biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential Vidofludimus calcium aim

  23. Slide 23: Vidofludimus Calcium in MS: Straightforward Path Towards Potential Regulatory Approval

    Vidofludimus Calcium in MS: Straightforward Path Towards Potential Regulatory Approval ENSURE CALLIPER ENSURE-1 ENSURE-2 NDA Interim Analysis Readout Readout Readout Submission Late 2024 April 2025 End of 2025 2026 2026 2024 2025 2026 Phase 3 ENSURE-1 Trial in RMS Phase 3 ENSURE-2 Trial in RMS Phase

  24. Slide 24: Consistent and Differentiated Results to Date in Both RMS and PMS

    Consistent and Differentiated Results to Date in Both RMS and PMS Assembling the Basis for Potential Regulatory Approvals Full readout of phase 3 ENSURE program in RMS Full readout of phase 2 CALLIPER trial in PMS Positive phase 2 data in RRMS open-label extension phase demonstrating signal for impr

  25. Slide 25: Q&A Session

    i= Immunic THERAPEUTICS Q&A Session Interim Analysis of the Phase 2 CALLIPER Trial

  26. Slide 26: Thank You!

    Thank You! Immunic, Inc. 1200 Avenue of the Americas New York City, NY 10036 USA Immunic AG Lochhamer Schlag 21 82166 Grifelfing (Munich) Germany Jessica Breu Head of IR & Communications & Phone: +49-89-2080477-09 & Email: ir@imux.com ® Web: www.imux.com Immunic Australia Pty. Ltd. Melbourne Austral

  27. Slide 27: Backup

    & |Immunic THERAPEUTICS Backup Interim Analysis of the Phase 2 CALLIPER Trial

  28. Slide 28: Key Challenge in All Forms of MS: Disability Worsening Over Time

    Key Challenge in All Forms of MS: Disability Worsening Over Time RRMS: = Dominated by focal inflammatory disease (MRI lesions) and relapses = Disability progression caused by RAW and PIRA almost equally” = RAW and PIRA contributing to disability worsening = Treated with approved anti- inflammatory d

  29. Slide 29: Patient Demographics and Baseline Characteristics

    Patient Demographics and Baseline Characteristics Total Study Population of 467 Enrolled Patients Progressive Disease Subtypes Baseline Characteristics = Primary progressive MS = Non-active secondary progressive MS Active secondary progressive MS Total N=467 Disease ubtypeinformation are used as dia

  30. Slide 30: Overall PMS Population: Change in Serum NfL

    Overall PMS Population: Change in Serum NfL Compared to Normalized Baseline Total Interim Analysis Population (24-Week Completer) 48-Week Completer Subpopulation N=102 (45 mg IMU-838), N=101 (Placebo) N=41 (45 mg IMU-838), N=38 (Placebo) 4 4 Po a= 22 ‘Ss a & 2 le 2 fo4{— zo g 8 0.29 8 8 -1.73%) 1.72

  31. Slide 31: Overall PMS Population: Change in Serum NfL, Post-Hoc Analysis

    Overall PMS Population: Change in Serum NfL Post-Hoc Statistical Analysis of Change from Baseline to Week 24 Total Interim Analysis Population (24-Week Completer) N=102 (45 mg IMU-838), N=101 (Placebo) Parts 5 - Nominal Change in NfL Post-Hoc Statistical Analysis: from BLto W24 4 +2.705 L s ee) The

  32. Slide 32: Change in Serum NfL by PMS Disease Subtype

    Change in Serum NfL by PMS Disease Subtype Change from Baseline to Week 24 in % of Baseline PPMS n-aSPMS aSPMS 40% 35.6% 30% 568 17.8% 10.8% 10% -10% Pe 7.7% -20% -30% N=32 (IMU-838) N=62 (IMU-838) N=8 (IMU-838) 10% N=27 (Placebo) N=62 (Placebo) N=12 (Placebo) 45 mgIMU-838 ™ Placebo ‘Standard devati

  33. Slide 33: Change in Serum NfL by Active Disease Status During Study

    Change in Serum NfL by Active Disease Status During Study Change from Baseline to Week 24 in % of Baseline, 45 mg of Vidofludimus Calcium aPMS n-aPMS 18.8% oo 13.8% 5% -2.6% -15% =12.9% N=27 (IMU-838) N=75 (IMU-838) N=35 (Placebo) N=66 (Placebo) m45 mg IMU-838 = Placebo ‘Active Dizease=any MS dizear

  34. Slide 34: Change in Serum NfL by MRI Activity During Study

    Change in Serum NfL by MRI Activity During Study Change from Baseline to Week 24 in % of Baseline, 45 mg of Vidofludimus Calcium aMRI n-aMRI 21.1% 15% 12.7% 15% -12.6% N=26 (IMU-838) N=76 (IMU-838) N=32 (Placebo) N=69 (Placebo) m45 mg IMU-838 Bi Placebo [Active MRI = activity shown as<newor enlargin

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