Immunic, Inc. · NASDAQ:IMUX

Immunic — Investor Presentation (July 2021)

33 slides from Immunic's investor presentation, Jul 1, 2021

  1. Slide 1: Immunic Therapeutics

  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: 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. | Jul/o1/2021 & Immunic

  4. Slide 4: Development Pipeline

    Development Pipeline Program | Indication Target Preclinical Phase 1 Phase 2 Phase 3 IMu-838 Relapsing-Remitting Multiple Sclerosis Progressive Multiple Sclerosis, Ulcerative Colitis DHODH Crohn's Disease DHODH ee ee Primary Selerosing Cholangitis DHODH es eel Imu-935 Psoriasis RORyt —SSSen Guillain

  5. Slide 5: IMU-838 is Targeted to be the Easy-to-Use Approach for Patients With MS

    IMU-838 is Targeted to be the Easy-to-Use Approach for Patients With Multiple Sclerosis (MS) IMU-838 is intended to be: = the 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 Advant

  6. Slide 6: IMU-838: Phase and Approval Strategy in Multiple Sclerosis

    IMU-838: Phase 3 and Approval Strategy in Multiple Sclerosis Phase 3 ENSURE Program in RRMS Phase 2 CALLIPER Trial in PMS = Two identical pivotal trials in RRMS patients = Phase 2 trial in PMS patients = Placebo-controlled = Goal: Corroborate IMU-838’s potential for = Goal: Regulatory approval of IM

  7. Slide 7: Phase 3 ENSURE Program in Relapsing-Remitting Multiple Sclerosis (RRMS)

  8. Slide 8: Phase 3 ENSURE Program of IMU-838 in RRMS

    Phase 3 ENSURE Program of IMU-838 in RRMS = U.S. Food and Drug Administration cleared Immunic’s investigational new drug (IND) application = Dosing of the first patient expected in H2/2021

  9. Slide 9: ENSURE: Overview Pivotal Phase 3 Program in RRMS

    ENSURE: Overview Pivotal Phase 3 Program in RRMS x Coordinating Investigator eh Two Multicenter, Randomized, = Double-Blind Phase 3 Trials Robert J. Fox, M.D. Cleveland Clinic B) Included Patient Population: 2) Relapsing Forms of MS Approximately 1,050 patients in each trial More than 100 sites in t

  10. Slide 10: ENSURE: Overview Pivotal Phase 3 Program in RRMS

    10 | ©immunic, inc. | Jul/o1/2021 ENSURE: Overview Pivotal Phase 3 Program in RRMS ENSURE-1: IMU-838 vs. Placebo ENSURE-2: IMU-838 vs. Placebo . 72 Weeks 2 7 72 Weeks , N=525 IMU-838 N=525 IMU-838 N=525 Placebo N=525 Placebo & Immunic

  11. Slide 11: ENSURE: General Phase 3 Study Design in RRMS

    ENSURE: General Phase 3 Study Design in RRMS 5 P, d Main Treatment Period creening Perios 72 Weeks (Blinded) 30 mg IMU-838, 30 mg IMU-838, {oT >—< Eos) . Placebo Visits every 12 weeks Visits every 24/48 weeks DO w24 W438 W72 /EoMT w120 EoT EoS: 1° analysis (EoT+30d) = Primary endpoint: delaying the

  12. Slide 12: ENSURE: Powering Assumptions and Interim Analysis

    ENSURE: Powering Assumptions and Interim Analysis vam x Event-Based Sample Size Calculation Q Interim Analysis = Primary endpoint for both trials is time to first = After approximately half of the events in the relapse up to 72 weeks double-blind treatment period = Each trial is 90% powered at a 0.0

  13. Slide 13: ENSURE is Intended to Provide a Straightforward Path to Regulatory Approval

    ENSURE is Intended to Provide a Straightforward Path to Regulatory Approval IMU-838 development goals in MS: achieve market approval and confirm product differentiation based on safety, tolerability, efficacy and neuroprotective properties of IMU-838. Immunic believes that the phase 3 program provid

  14. Slide 14: Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis (PMS)

  15. Slide 15: Progressive Multiple Sclerosis (PMS) is Characterized by Gradual Accrual of Disability

    Progressive Multiple Sclerosis (PMS) is Characterized by Gradual Accrual of Disability Independent of Relapses Over Time 15 | ©immunic, inc. | Jul/o1/2021 PMS includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS). PPMSS is characterized by steadily worsening neurologic func

  16. Slide 16: Robert J. Fox, M.D. Quote

    q) q) Robert J. Fox, M.D. Cleveland Clinic “Disability progression is a principal concern for clinicians and patients of both PMS and RRMS. The ongoing disability worsening, even in periods without relapse, not only diminishes quality-of-life but can also ultimately lead to profound impairments in p

  17. Slide 17: DHODH Provides Proven Mechanism for Neuroprotection

    DHODH Provides Proven Mechanism for Neuroprotection DHODH Inhibitors Have Successfully Shown Neuroprotective Effects Teriflunomide has demonstrated a clear and statistically Teriflunomide has demonstrated a clear effect slowing significant advantage regarding brain atrophy in RRMS disability progres

  18. Slide 18: Phase 2 Data of IMU-838 in RRMS Showed Evidence of Potential Neuroprotective Activity

    Phase 2 Data of IMU-838 in RRMS Showed Evidence of Potential Neuroprotective Activity F - i i [2] Robust Decrease in Serum Neurofilament Light Chain (NfL) NfL has been shown consistently to correlate with disease activity in neurological disorders and has become one of the most importantserum biomar

  19. Slide 19: Phase 2 CALLIPER Trial of IMU-838 in PMS

    Phase 2 CALLIPER Trial of IMU-838 in PMS = U.S. Food and Drug Administration cleared Immunic’s investigational new drug (IND) application = Dosing of the first patient expected in Q3/2021

  20. Slide 20: CALLIPER: Phase 2 Trial Overview in PMS

    CALLIPER: Phase 2 Trial Overview in PMS x Coordinating Investigator | Multicenter, Randomized, Double-Blind, nl] Placebo-Controlled Phase 2 Trial Robert J. Fox, M.D. Cleveland Clinic Included Patient Population: Progressive Forms of MS Approximately 450 patients More than 70 sites in North America,

  21. Slide 21: CALLIPER: Phase 2 Trial Design in PMS

    CALLIPER: Phase 2 Trial Design in PMS Screening Period Visits every 12 weeks EE» Visits every 24/48 weeks 45 mg IMU-838 aa R | L 45 mg IMU-838 — EoT — Eos Screening Giese & exam BLMRI (Gd+) MRI(Gd+) MRI (Gd#) MRI MRI l L a N l L a D28te-3 D8tel DL wes was wr EoMT™ 0s ue waa Ole wae fot £0S/ (EoMT+ (

  22. Slide 22: CALLIPER is Designed to Support IMU-838's Overall Positioning

    CALLIPER is Designed to Support IMU-838’s Overall Positioning and the Phase 3 Program in RRMS CALLIPER is intended to run concurrently with and to complement the phase 3 program in RRMS. CALLIPER is designed to corroborate IMU-838’s neuroprotective potential, as exemplified by slowing of brain atrop

  23. Slide 23: IMU-838 is Designed to be an Easy-to-Use, Uniquely Safe MS Treatment

  24. Slide 24: 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

  25. Slide 25: 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

  26. Slide 26: Existing First-Line and Oral MS Drugs Leave Much to be Desired

    Existing First-Line and Oral MS Drugs Leave Much to be Desired @evibenter Interferons Teriflunomide ese Cladribine S1P Modulators Acetate Fumarate Oral? @ 9 =) e i) @ Relapse Reduction @ Q Q @ @ @ Prevention of Disability Worsening ] @ @ @ @ @ Tolerability e @ @ @ Qo @ Safety @ @ 9 1s) @ e Absence o

  27. Slide 27: Strong Phase 2 Data of IMU-838 in RRMS Supports Desired Product Target Profile

    Strong Phase 2 Data of IMU-838 in RRMS Supports Desired Product Target Profile Strong Phase 2 Data Underlines Robust Phase 2 Data Also Confirms Best-in-Class Efficacy With Neuroprotective Potential Safety and Tolerability = Suppression of MRI lesions (p< 0.001): met primary and = Administration of I

  28. Slide 28: IMU-838's Safety Profile is Unique

    IMU-838’s Safety Profile is Unique Macular Edema imu-838 — [Teriflunomidel™ oe Cladribine! | Fingolimod'! | siponimod® | Ponesimod'” | Ozanimod'® Fumarate PML Risk @ e @ @ @ @ ie} o Increased Number of Infections e co) @ o) o) eo) Q Vaccination Limitations eo e @ @ @ ie} e) Gastrointestinal Toxiciti

  29. Slide 29: 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

  30. Slide 30: IMU-838: Full Prescription Coverage Achievable at Attractive Pricing Range

    IMU-838: Full Prescription Coverage Achievable at Attractive Pricing Range gq Historically, differentiated innovator drugs have not experienced price impactseven when generics are approved for a related or similar Immunic Hired Third-Party Pricing Experts to Perform Landscape Analysis for IMU-838 Pr

  31. Slide 31: Summary

  32. Slide 32: IMU-838 is Targeted to be the Easy-to-Use Approach for Patients With MS

    IMU-838 is Targeted to be the Easy-to-Use Approach for Patients With Multiple Sclerosis (MS) IMU-838 is intended to be: ©} = the once-daily medication for MS patients with a well-balanced combination of a favorable safety and convenience profile with robust clinical activity = FDA clearance allows i

  33. Slide 33: Thank You!

    Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 33 | ©immunic, inc. | Jul/o1/2021 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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