Immunic, Inc. · NASDAQ:IMUX

Immunic — FY2021 Earnings Presentation

33 slides from Immunic's earnings presentation, Feb 24, 2022

  1. Slide 1: Immunic Therapeutics Fourth Quarter and Year-End 2021 Financial Results and Corporate Update

  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 216 of the Securities

  3. Slide 3: Agenda

    Agenda Fourth Quarter and Year-End 2021 Financial Results and Corporate Update Fourth Quarter 2021 and Subsequent Highlights 04 | Q&A Session 02 Financial and Operating Results Summary and Highlights Anticipated Clinical Milestones 3 | ©immunic, inc. | Feb/24/2022 & Immunic

  4. Slide 4: Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022

    Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022 = Completed or ongoing 4 Program _| Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones RMS interim analysis planned after approx. half of the events occurred PMS interim analysis planned after half of

  5. Slide 5: Fourth Quarter 2021 and Subsequent Highlights

  6. Slide 6: October: Appointed Patrick Walsh to the Newly Created Role of Chief Business Officer

    October: Appointed Patrick Walsh to the Newly Created Role of Chief Business Officer Mr. Walsh is responsible for business development, including strategic partnering opportunities, and has become part of the executive management team of Immunic. Mr. Walsh joined Immunic from Akebia Therapeutics, In

  7. Slide 7: October: Dosed the First Patient With Moderate-to-Severe Psoriasis in Part C of IMU-935 Trial

    October: Dosed the First Patient With Moderate-to-Severe Psoriasis in Part C of the Ongoing Phase 1 Trial of IMU-935 Phase 1 Clinical Trial: Actively Enrolling Psoriasis Patients in Part C = Double-blind, placebo-controlled dose escalation study to evaluate safety, tolerability, pharmacodynamics and

  8. Slide 8: October: Randomized the Last Patient in the Phase 2 CALDOSE-1 Trial in Ulcerative Colitis

    October: Randomized the Last Patient in the Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Patients With Ulcerative Colitis* jon Phase Maintenance Phase Placebo (n=60) > — Placebo (n=60) Optional 10 mg IMU-838 QD open-label —_———— Patients with (n=60) 2 symptomatic extension remission [> 10mg IM

  9. Slide 9: November: Enrolled the First Patient in the Phase 3 ENSURE Program in RMS

    November: Enrolled the First Patient in the Phase 3 ENSURE Program of Vidofludimus Calcium in RMS Phase 3 ENSURE Program in RMS Phase 2 CALLIPER Trial in PMS = Two identical pivotal trials in RMS patients * Phase 2 trial in PMS patients = Goal: Demonstrate vidofludimus calcium’s potential for neurop

  10. Slide 10: December: Enrolled the First Patient in the Open-Label Phase 1 Trial of IMU-935 in mCRPC

    December: Enrolled the First Patient in the Open-Label Phase 1 Clinical Trial of IMU-935 in mCRPC Study Design = Open-label dose escalation trial to evaluate safety, tolerability, anti-tumor activity, and pharmacokinetics of IMU-935 in patients with progressive, metastatic castration-resistant prost

  11. Slide 11: December: Reported Positive Unblinded Safety, Tolerability and PK Results of IMU-935 Phase 1

    December: Reported Positive Unblinded Safety, Tolerability and PK Results of Phase 1 Clinical Trial of IMU-935 in Healthy Human Subjects PART A part B part C Evaluation of Evaluation of Evaluation of single ascending doses (SAD) multiple ascending doses (MAD) moderate-to-severe psoriasis = = patient

  12. Slide 12: December: Announced Newly Available In Vivo Data for IMU-935

    December: Announced Newly Available /n Vivo Data for IMU-935 Maintains Normal Thymocyte Maturation in Relevant Acute and Chronic Mouse Models Acute Model, 3 Days of Treatment Thymic cellularity (1X107) ‘Guo et al, 2016 Cell Reports (MRL-S71),Guntemannet al, 2017, Insight (Cpt), Mahalingamet a, 2018,

  13. Slide 13: February 2022: Received Notice of Allowances for Composition-of-Matter Patents for IMU-935

    February 2022: Received Notice of Allowances for Composition- of-Matter Patents for IMU-935 Received Notice of Allowance from the U.S. Patent and Trademark Office for patent application 16/644581, entitled, “IL-17 and IFN-gamma inhibition for the treatment of autoimmune diseases and chronic inflamma

  14. Slide 14: February 2022: Presented Preclinical Data for Vidofludimus Calcium at ECCO Congress

    February 2022: Presented Preclinical Data for Vidofludimus Calcium at the 17th Congress of European Crohn’s and Colitis Organization = Vidofludimus calcium reduces proinflammatory immune cell responses by inducing regulatory macrophages, reducing Highlights Include: FRI IKK pro-inflammatory cytokine

  15. Slide 15: February 2022: Announced Blinded Baseline Characteristics of Phase 2 CALDOSE-1 Trial

    February 2022: Announced Blinded Baseline Characteristics of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in UC 271 The Main Blinded Baseline Characteristics of the CALDOSE-1 Trial Include: = 263 moderate-to-severe UC patients were enrolled in 78 study sites = 83% were biologically naive and 17%

  16. Slide 16: Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS: Final Cohort 2 Data Now Available

  17. Slide 17: Vidofludimus Calcium Phase 2 EMPhASIS Trial in RRMS: MRI Lesion Reduction

    Vidofludimus Calcium Phase 2 EMPhASIS Trial in RRMS Reduction of MRI Lesion Activity (Pooled Cohorts 1 & 2) Reduction in Cumulative CUA Lesions up to Week 24 meee -71% Placebo 1OmgiMU-838 30 mgiMU-838 45 mgiMU-838 mm Cumulative CUA Lesions. ~®=Lesion Reduction in% Reduction in Gd+ Lesions up to Week

  18. Slide 18: Vidofludimus Calcium Phase 2 EMPhASIS Trial in RRMS: Serum NfL Concentrations

    Vidofludimus Calcium Phase 2 EMPhASIS Trial in RRMS Relative Change of Serum NfL Concentrations Versus Placebo After 24 Weeks (Cohorts 1 & 2) 50% The relative change of serum neurofilament light chain versus placebo is proportional to vidofludimus calcium dose. = May reflect increasing trough -9% le

  19. Slide 19: Vidofludimus Calcium Phase 2 EMPhASIS Trial in RRMS: EDSS Assessments

    Vidofludimus Calcium Phase 2 EMPhASIS Trial in RRMS Encouraging Signals of Neuroprotective Effects Based on EDSS Assessments (Cohorts 1 & 2) Change of EDSS from Baseline to Week 24 Proportion of Patients With Unconfirmed EDSS Progression up to Week 24 Percent 29 25 211% 28 20 27 35 SS aise 11.8% 12.

  20. Slide 20: Clinical Data of Vidofludimus Calcium in the COVID-19 Context

    Clinical Data of Vidofludimus Calcium in the COVID-19 Context Treatment Does Not Interfere With Antibody Opportunistic COVID-19 Infections Development During SARS-CoV-2 Infection Treatment Tends to Decrease the Number of ee Placebo Day 6 Day 14 Day 28 (10 mg Qp) ” ay ay IgA IgG IgA IgG IgA IgG Any I

  21. Slide 21: Vidofludimus Calcium: Potent Anti-EBV Activity Demonstrated in Cell-Culture-Based Systems

    Vidofludimus Calcium: Potent Anti-EBV Activity Demonstrated in Cell-Culture-Based Systems Anti-Akata-BX1-EBV-GFP stimulated with higG 110- 100: : a Z 90. 2 80. 3 Vidofludimus calcium showed concentration- € . dependent anti-EBV = 50 a activity at concentrations of Fa 40. a 3.3-30 uM in Raji and B95-

  22. Slide 22: CNS Penetration of Vidofludimus in Rats

    CNS Penetration of Vidofludimus* in Rats Targeted Quantification in Cerebrospinal Fluid (CSF) via LC-MS Vidofludimus CSF Versus Blood Plasma Mean Concentration (Rat) ae So nous hey nn samersinn) Post-Dose Post-Dose Blood Serum 9,737 8,792 CSE 2,591 1,175 Relationship of Vidofludimus Concentration 26

  23. Slide 23: Financial and Operating Results

  24. Slide 24: Consolidated Statements of Operations

    Consolidated Statements of Operations (In thousands, except share and per share amounts, unaudited) Years Ended December 31, 2024 2020 Operating expenses: Research and development $ 61,115 $ 38,637 General and administrative 13,300 10,334 ASC Royalty Settlement 17,250 = Total operating expenses 91,6

  25. Slide 25: Anticipated Clinical Milestones

  26. Slide 26: Vidofludimus Calcium in Ulcerative Colitis

    _) Vidofludimus Calcium in Ulcerative Colitis Top-line data of the induction phase of the phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC are expected to be available in June of 2022. 26 | ©immunic, inc. | Feb/24 & |mmunic

  27. Slide 27: IMU-935 Phase 1 Program: Part C in Psoriasis

    IMU-935 Phase 1 Program: Part C in Psoriasis Initial results from the third portion of the phase 1 clinical trial of IMU-935 in patients with moderate-to-severe psoriasis are expected to be available in H2/2022. & Immunic

  28. Slide 28: IMU-935 Phase 1 Trial in CRPC Principal Investigator

    IMU-935 Phase 1 Trial in CRPC 4 Principal Investigator Johann Sebastian de Bono, M.D., Ph.D. Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust London, United Kingdom Initial clinical safety da

  29. Slide 29: IMU-856 Phase 1 Program

    IMU-856 Phase 1 Program The SAD part of the ongoing phase 1 clinical trial of IMU-856 has been completed. Based on the favorable data available so far, the Ethics Committee in Australia has agreed to proceed to the MAD part which is currently being dosed. Unblinded safety data from the SAD and MAD p

  30. Slide 30: Q&A Session

  31. Slide 31: Summary and Highlights

  32. Slide 32: Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022

    Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022 Advanced clinical pipeline: | three differentiated products in various phases of clinical development ty @) RMS phase 3 program of vidofludimus as calcium ongoing, to be supported by neuroprotective data from

  33. Slide 33: Thank You!

    Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 33 | ©lmmunic, nc. | Feb/24/2022 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 Immu

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