Slide 1: Immunic Therapeutics Second Quarter 2022 Financial Results and Corporate Update
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: Agenda
Agenda Second Quarter 2022 Financial Results and Corporate Update 02 | Second Quarter 2022 and Subsequent Highlights 04 | Anticipated Clinical Milestones 02 | Clinical Updates Q&A Session 03 | Financial and Operating Results 06 | Summary and Highlights 3 | ©immunic, inc. | Aug/04/2022 Immunic
Slide 4: Second Quarter 2022 and Subsequent Highlights
Slide 5: May: Announced Start of Celiac Disease Cohorts in Ongoing Phase 1 Clinical Trial of IMU-856
May: Announced Start of Celiac Disease Cohorts in Ongoing Phase 1 Clinical Trial of IMU-856 5 Double-blind, randomized, placebo-controlled phase 1 study performed in three parts: = Safety and pharmacokinetics in healthy human subjects (Part A: single ascending dose, Part B: multiple ascending dose)
Slide 6: June: Reported Top-Line Data from Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in UC
June: Reported Top-Line Data from Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Patients with Moderate-to-Severe UC = Revealed a previously unknown interaction with chronic concurrent steroid use, resulting in missing the trial’s primary endpoint = Announced that the company’s development progr
Slide 7: June: Announced Publication of Data from Phase 2 EMPhASIS Trial in RRMS
June: Announced Publication of Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS in Peer Reviewed Journal = Published in the peer reviewed journal, RESEARCH ARTICLE A double-blind, randomized, placebo-controlled phase 2 Annals of Clinical and Translational Neurology trial evaluating t
Slide 8: July: Announced Appointment of Maria Tornsén to Board of Directors
July: Announced Appointment of Maria Tornsén to Board of Directors = Industry executive with 20 years of global commercial experience in U.S. and ex-U.S. markets = Jan Van den Bossche resigned from the Board = Both effective July 5, 2022 & Immunic
Slide 9: Clinical Updates
Slide 10: EMPhASIS Trial: Post-Hoc Analysis Shows Concomitant Corticosteroids Treatment in RRMS Patients is Rare and Short
EMPhASIS Trial: Post-Hoc Analysis Shows That Concomitant Corticosteroids Treatment in RRMS Patients is Rare and Short Concomitant Corticosteroids Concomitant Corticosteroids Treatment Was Rare Treatment Was Short = Overall, few patients required concurrent corticosteroid Corticosteroids were used on
Slide 11: Exploratory Phase 1 Drug-Drug Interaction (DDI) Study of IMU-935 Raised No Concerns
Exploratory Phase 1 Drug-Drug Interaction (DDI) Study of IMU-935 Raised No Concerns Exploratory phase 1 study completed in 15 evaluable healthy human subjects to assess the DDI potential of IMU-935 No relevant signals for DDI potential observed Treatment was safe and well- tolerated & Immunic
Slide 12: Update on Phase 1 Clinical Trial of IMU-935 in mCRPC
Update on Phase 1 Clinical Trial of IMU-935 in mCRPC Initial Safety Data Available & Initial safety data available so far show a promising safety profile of IMU-935 in metastatic castration-resistant prostate cancer (mCRPC). = Open-label dose escalation trial to evaluate safety, tolerability, anti-t
Slide 13: Financial and Operating Results
Slide 14: Consolidated Statements of Operations
Consolidated Statements of Operations (In thousands, except share and per share amounts, unaudited) Three Months: ‘Six Months Ended June 30, Ended June 30, 2022 2028 2022 2021 (Operating expenses: Research and development $ $15,738 $33,983 $ General and administrative 3.432 8082 4SC royalty settleme
Slide 15: Anticipated Clinical Milestones
Slide 16: Vidofludimus Calcium in Multiple Sclerosis: Executive Summary
Vidofludimus Calcium in Multiple Sclerosis Executive Summary Phase 3 program of vidofludimus calcium in RMS ongoing based on excellent clinical data package = Demonstrated effect on all relevant endpoints in 268 RRMS patients, including anti-inflammatory & neuroprotective effects = Unrivaled safety
Slide 17: Key Publications in 2022 Provide Clear Evidence of a Direct Link Between Epstein-Barr Virus and MS
Key Publications in 2022 Provide Clear Evidence of a Direct Link Between Epstein-Barr Virus and MS = Epidemiologic study showed a clear association between EBV infection and occurrence of MS": — 32-fold increased risk in EBV-infected patients — Serum levels of neurofilament light chain increased onl
Slide 18: Vidofludimus Calcium in Multiple Sclerosis: Straightforward Approval Strategy
Vidofludimus Calcium in Multiple Sclerosis Straightforward Approval Strategy Phase 3 ENSURE Program in RMSE 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 neuroprotective activity
Slide 19: IMU-935 Phase 1 Clinical Trial
IMU-935 Phase 1 Clinical Trial Part C in Moderate-to-Severe Psoriasis Patients Recruitment is ongoing in Australia, New Zealand and Bulgaria. Initial clinical activity results are expected to be available in Q4/2022. & Immunic
Slide 20: IMU-856 Phase 1 Clinical Trial
» IMU-856 Phase 1 Clinical Trial Unblinded safety data from the single and multiple ascending dose parts of IMU-856 in healthy human subjects are expected to be available in Q3/2022. & |Immunic
Slide 21: Q&A Session
Slide 22: Summary and Highlights
Slide 23: Advanced Clinical Pipeline
Advanced Clinical Pipeline Three Differentiated Programs in Various Phases of Clinical Development Program | Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones = RMSinterim analysis planned after approx. half of the events occurred Vidofludimus Calcium DHODH = PMS interim analysis planned aft
Slide 24: Thank You!
Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 24 | ©immunic, inc. | Aug/o4/2022 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 Imm