Immunic, Inc. · NASDAQ:IMUX
Immunic — Investor Day (November 2026)
56 slides from Immunic's investor day presentation, Nov 5, 2026
Slide 1: Progressive Multiple Sclerosis R&D Day
Progressive Multiple Sclerosis R&D Day November 5, 2026 Virtual NASDAQ: IMUX © Immunic, Inc. | Nov 2026 1
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 21E of the Securities
Slide 3: Today's Speakers
Virtual Progressive Multiple Sclerosis R&D Day: Today’s Speakers Immunic Speakers Featured Experts Erik Lundgren, MBA Jason Tardio, MBA Jiwon Oh, MD, PhD, FRCPC Maria Pia Sormani, PhD Chief Executive Officer President & Chief Operating Officer University of Toronto University of Genoa Moderator Mich
Slide 4: Agenda: Virtual Progressive Multiple Sclerosis R&D Day
Vidofludimus Calcium – Targeting Key Unmet Needs in Progressive MS Agenda Virtual Progressive Multiple Sclerosis R&D Day Erik Lundgren 12:30 - 12:35 Welcome and Introduction Chief Executive Officer Jiwon Oh, MD, PhD, FRCPC 12:35 - 12:45 Expert Talk: Unmet Needs and Progression in MS University of To
Slide 5: Welcome and Introduction
Welcome and Introduction Erik Lundgren I Chief Executive Officer
Slide 6: Immunic: Pivoting to a Fully Integrated Multiple Sclerosis Company
Immunic: Pivoting to a Fully Integrated Multiple Sclerosis Company Advancing a Potentially Differentiated Oral MS Therapy to Address High Unmet Needs Near-Term Value Inflection Significant Upside Potential in Relapsing Multiple Sclerosis in Progressive Multiple Sclerosis Lead A ss et Vidofludimus Ca
Slide 7: Vidofludimus Calcium Is Being Developed as a Franchise Opportunity Spanning Relapsing and Progressive MS
Vidofludimus Calcium Is Being Developed as a Franchise Opportunity Spanning Relapsing and Progressive MS PR OGR AM IND IC AT IO N PR E CL INI CAL PH AS E 1 PH AS E 2 PH AS E 3 ST AT US NE XT MI LE S TO NE Vidofludimus Relapsing MS Top-line data for both trials Calcium Both trials fully enrolled ENSU
Slide 8: Building a Leading MS Company: A Phased Commercial Strategy
Building a Leading MS Company: A Phased Commercial Strategy Relapsing MS Establishes Commercial Foundation; Progressive MS Drives Long-Term Value Creation BECOME A GLOBAL MS LEADER (2032+) SCALE & GENERATE CASH FLOW Capture a substantially larger market (2028-2032) opportunity through expansion into
Slide 9: Expert Talk: Jiwon Oh, MD, PhD, FRCPC
Expert Talk: Jiwon Oh, MD, PhD, FRCPC Medical Director, Barlo Multiple Sclerosis Program Waugh Family Chair in MS Research Staff Neurologist, St. Michael’s Hospital Scientist, Keenan Research Centre of the Li Ka Shing Knowledge Institute Associate Professor, Division of Neurology, University of Toro
Slide 10: Vidofludimus Calcium's Differentiated Mode of Action: Direct Nurr1 Activator
Vidofludimus Calcium's Differentiated Mode of Action: Direct Nurr1 Activator Hella Kohlhof, PhD I Co-Founder & Chief Scientific Officer
Slide 11: Nurr1 Is a Transcription Factor Linked to Neuroprotection and Inflammatory Signaling
Nurr1 (NR4A2) Is a Transcription Factor Linked to Neuroprotection and Regulation of Inflammatory Signaling Nurr1 (NR4A2) Microglia Member of the NR4A family of orphan Emerging evidence supports a potential role in MS4-6 nuclear receptor transcription factors Relapsing MS and expressed in neurons, mi
Slide 12: Vidofludimus Calcium: A Differentiated Dual Mechanism Approach to MS
Vidofludimus Calcium: A Differentiated Dual Mechanism Approach to MS Direct Nurr1 Activator Selective DHODH Inhibitor Nurr1 activation may support neuronal Vidofludimus calcium selectively inhibits resilience under inflammatory and oxidative DHODH limiting de novo pyrimidine stress. synthesis.
Slide 13: Nurr1 Is a Nuclear Receptor Involved in Neuroprotection
13 Nurr1 Is a Nuclear Receptor Involved in Neuroprotection GDNF microglia Nurr1 RET NO, ROS, TNFα neuronal survival and differentiation NO, ROS, BDNF TNFα Nurr1 Nurr1 IL1β, TNFα dopaminergic regulated Nurr1 neurotransmission genes TH, VMAT2 NO, ROS SOD1 COX5B Nurr1 oxidative cellular energy stress p
Slide 14: Vidofludimus Calcium Reduced Microglia Activation
Vidofludimus Calcium Reduced Microglia Activation Nurr1 can prevent antigen-induced activation of microglia and subsequent production of pro- inflammatory cytokines in the brain. Vidofludimus calcium attenuated LPS-stimulated IL-6, TNF⍺ and IFNγ production in human HMC3 microglial cells at low doses
Slide 15: Vidofludimus Calcium Increased Neuronal Viability Under Neuroinflammatory Condition
Vidofludimus Calcium Increased Neuronal Viability Under Neuroinflammatory Condition (Neuron-Microglia Co-Culture) Neuron-microglia co-culture LPS+IFNγ Vido Co-culture of activated microglia and neurons Vidofludimus calcium was associated with increased results in destruction of neurons. neuronal via
Slide 16: Vidofludimus-Associated Improved Neuronal Survival Requires Nurr1
Vidofludimus-Associated Improved Neuronal Survival Requires Nurr1 TNF⍺+CHX 6-OHDA Control Nurr1 KD Control Nurr1 KD CRISPR-mediated Nurr1 knockdown abolished the neuronal survival benefit of vidofludimus calcium under different models of apoptosis in SH-SY5Y line. Performed at City of Hope, USA, Zuo
Slide 17: Vidofludimus Calcium Improved Neuronal Survival Under Apoptotic Stress, Whereas Teriflunomide Did Not
Vidofludimus Calcium Improved Neuronal Survival Under Apoptotic Stress, Whereas Teriflunomide Did Not In this preclinical test system, teriflunomide did not significantly improve survival of neuronal cells. Performed at City of Hope, USA, Zuoming Sun © Immunic, Inc. | Nov 2026 17 TNFα: tumor necrosi
Slide 18: Is Every DHODH Inhibitor a Nurr1 Agonist? – NO!
Is Every DHODH Inhibitor a Nurr1 Agonist? – NO! ITC DSF ISOTHERMAL TITRATION CALORIMETRY DIFFERENTIAL SCANNING FLUORIMETRY ΔTM (melting temperature) shifts Vidofludimus Calcium indicate ligand-Nurr1 → Binding signal detected interaction Vidofludimus calcium induces a ΔTM shift; teriflunomide does no
Slide 19: Vidofludimus Calcium: Nurr1 Activation and Selective DHODH Inhibition
Vidofludimus Calcium: Nurr1 Activation and Selective DHODH Inhibition Improving survival of neurons Targeting metabolically active T & B cells Selective DHODH Inhibition Direct Nurr1 Activation Microglia B & T cells Neurons Reducing neurotoxic microglial activation Inhibition of EBV-associated B-cel
Slide 20: Expert Talk: Jiwon Oh, MD, PhD, FRCPC
Expert Talk: Jiwon Oh, MD, PhD, FRCPC Medical Director, Barlo Multiple Sclerosis Program Waugh Family Chair in MS Research Staff Neurologist, St. Michael’s Hospital Scientist, Keenan Research Centre of the Li Ka Shing Knowledge Institute Associate Professor, Division of Neurology, University of Toro
Slide 21: Expert Talk: Maria Pia Sormani, PhD
Expert Talk: Maria Pia Sormani, PhD Professor of Biostatistics University of Genoa, Italy
Slide 22: Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive MS
Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive MS Michael A. Panzara, MD, MPH I Chief Medical Officer
Slide 23: Progressive MS: Potential to Change Treatment Paradigm
Progressive MS: Potential to Change Treatment Paradigm Limited Treatment Options Available to Date With Many Patients Continuing to Worsen Despite Treatment Progressive MS New treatments should tackle the processes responsible for the continuous accumulation of disability in ~175K Diagnosed Patien
Slide 24: Progression in MS Is Increasingly Seen as a Continuum of Common Underlying Pathological Processes
Progression in MS Is Increasingly Seen as a Continuum of Common Underlying Pathological Processes MS patients share qualitatively 2024 revision of McDonald Revision of MS disease course similar (but quantitatively different) diagnostic criteria established a descriptors (Lublin-Reingold criteria) pa
Slide 25: CALLIPER: Phase 2 Clinical Trial in Progressive MS
CALLIPER: Phase 2 Clinical Trial in Progressive MS Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (NCT05054140) 467 Adult Patients Randomized, >340 Patients Continuing in OLE* Inclusion Criteria OLE Screening Main Treatment Period (Blinded) (optional) Period › Patients aged 18 to 65
Slide 26: CALLIPER: Patient Demographics and Baseline Characteristics
CALLIPER: Patient Demographics and Baseline Characteristics Total Study Population of 467 Enrolled Patients Progressive Disease Subtypes Baseline Patient Characteristics Age [years], median (min-max) 51.0 (21-65) N=47 10.1% Gender (n and % female) 302 (64.7%) N=152 32.5% Race (n and % White) 460 (98
Slide 27: CALLIPER: Statistical Significance Not Achieved on Primary PBVC Endpoint at Month 30
CALLIPER: Statistical Significance Not Achieved on Primary PBVC Endpoint at Month 30, Although Encouraging Trends on Regional Atrophy Re-Baselined at 6 Months 0 Primary Endpoint: Relative difference of Vidofludimus Calcium annual PBVC rate at 30 months: 4.7%; Placebo -0.2 95% CI, -0.285 to 0.379; P=
Slide 28: CALLIPER: Favorable Trends Across Exploratory Disability Outcomes Through Week 120
CALLIPER: Favorable Trends Across Exploratory Disability Outcomes Through Week 120 with a Nominally Significant Effect in CDI 24wCDW 24wCDI Favors Favors Hazard Ratio Favors Favors Hazard Ratio VidoCa/PBO VidoCa Placebo (95% CI) VidoCa/PBO Placebo VidoCa (95% CI) All Subjects 235/232 0.76 (0.48–1.21
Slide 29: CALLIPER: Exploratory MRI Endpoint Through Week 96, Mean Volume Change in T2 Lesions
CALLIPER: Exploratory MRI Endpoint Through Week 96 Mean Volume Change in New/Enlarging T2 Lesions 0.4 › Mean absolute volume of VidoCa Mean Absolute Change from Baseline new/enlarging T2 lesions through 0.3 Placebo week 96: A nominal significant reduction in T2 lesion volume was 0.2 seen at weeks 48
Slide 30: CALLIPER: Exploratory MRI Endpoint, Change in Slowly Expanding Lesions
CALLIPER: Exploratory MRI Endpoint Through Week 96 Mean Change from Baseline in Number of Slowly Expanding Lesions (SELs) 4 › The mean number of newly detected SELs VidoCa increased over time in both groups but was lower 3.5 Mean Change from Baseline Placebo with vidofludimus calcium than placebo 3
Slide 31: CALLIPER: Favorable Trends Across Exploratory Disability Outcomes Maintained Into Open-Label Extension
CALLIPER: Favorable Trends Across Exploratory Disability Outcomes Maintained Into Open-Label Extension Exploratory 24-Week CDW and CDI Outcomes by Subgroup Through OLE Cut-off 24wCDW – OLE ITT 24wCDI– OLE ITT Favors Favors Hazard Ratio Favors Favors Hazard Ratio VidoCa–VidoCa PBO–VidoCa VidoCa–VidoC
Slide 32: Net Clinical Benefit: Treated Patients 1.5x More Likely to Have Beneficial Disability Outcome
Net Clinical Benefit: Vidofludimus Calcium Treated Patients Were 1.5x More Likely to Have a Beneficial Disability Outcome Total Pairs Wins Losses Ties Win % Loss % Tie % Win Ratio 54520 12552 8284 33684 23.02% 15.19% 61.78% 1.51 Losses 8,284 W I N R AT I O Wins 12,552 (wins) 12,552 WR = = 1.51 8,284
Slide 33: CALLIPER: Favorable Safety and Tolerability Profile Through Week 120
CALLIPER: Favorable Safety and Tolerability Profile Through Week 120 Five Most Common TEAEs Placebo (n=232) 45 mg Vidofludimus Calcium (n=235) Urinary tract infection 36 (15.5) 39 (16.6) Headache 16 (6.9) 10 (4.3) › No new safety signals observed Back pain 17 (7.4) 9 (3.8) during main treatment peri
Slide 34: CALLIPER: Low Treatment Discontinuations Through Week 120
CALLIPER: Low Treatment Discontinuations Through Week 120 › 82.8% (387/467) of trial Treatment Discontinuations participants elected to enter the Placebo 45mg Vidofludimus Calcium open-label extension. Treatment period 120 weeks 120 weeks › During the main treatment period, which extended to 120 wee
Slide 35: PROTECT-MS
PROTECT-MS Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate Efficacy, Safety, and Tolerability of IMU-838 (Vidofludimus Calcium) in Participants with Progressive Multiple Sclerosis
Slide 36: PROTECT-MS Study Population
PROTECT-MS Study Population Key Inclusion Criteria: + Age 18-65 + Non-active SPMS or PPMS PROTECT-MS will evaluate the + No disease activity (relapses or new MRI lesions) in the prior 2 years spectrum of progressive MS by + Disability progression documented in the prior year enrolling people with no
Slide 37: PROTECT-MS Study Design
PROTECT-MS Study Design Key Objective: Study design is not final and is subject to change. CDW: confirmed disability worsening To determine if vidofludimus calcium impacts disability progression in people with progressive MS Screening Period Main Period Optional Extension Period Vidofludimus calcium
Slide 38: PROTECT-MS Study Endpoints
PROTECT-MS Study Endpoints Primary Endpoint: Time to 24-Week Confirmed Disability Worsening (CDW) or 9HPT Secondary and Exploratory Endpoints Disability Imaging PROs Confirmed disability improvement (CDI) Slowly expanding lesions (SEL) Quality of life Net clinical benefit (impact on CDW & CDI) Param
Slide 39: Vidofludimus Calcium in Progressive MS: Treatment Paradigm Changing Potential
Vidofludimus Calcium in Progressive MS: Treatment Paradigm Changing Potential Strong Imaging and Exploratory Disability Phase 2 Efficacy Signals* Initiation of Phase 3 clinical trial in Favorable and Consistent Safety Profile at 45 mg Dose › progressive MS ongoing, with first- patient-enrolled expec
Slide 40: Commercial Opportunity for Vidofludimus Calcium in Progressive MS
Commercial Opportunity for Vidofludimus Calcium in Progressive MS Jason Tardio I President & Chief Operating Officer
Slide 41: The Significant Unmet Need in Progressive MS Creates a Compelling Opportunity
The Significant Unmet Need in Progressive MS Creates a Compelling Opportunity for Differentiated Therapies Progressive MS (SPMS and PPMS) affects ~25% of people diagnosed with MS 1 and remains a major Substantial area of unmet need, with irreversible disability accumulation, high patient and caregiv
Slide 42: Progressive MS Places a Substantial Economic Burden on Patients, Families and Healthcare System
Progressive MS Places a Substantial Economic Burden on Patients, Families and the Healthcare System Worsening disability in nrSPMS and PPMS drives higher healthcare Healthcare Costs Are Significantly Higher in Progressive MS utilization, greater need for supportive care and long-term services, and M
Slide 43: Neurologists Highlight the Critical Need for New Disease-Modifying Therapies in Progressive MS
Neurologists Highlight the Critical Need for New Disease-Modifying Therapies in Progressive MS General Neurologists (n=71) MS Specialists (n=29) “ We need a safe and effective oral treatment 69% for progressive MS. New products to treat PIRA 86% New DMTs for PPMS 72% 72% “ Always room for improved e
Slide 44: Anti-CD20 Therapies Dominate Progressive MS Treatment
Anti-CD20 Therapies Dominate Progressive MS Treatment, Highlighting the Need for Alternative Therapeutic Options Physician-Reported DMT Class Share in MS Subtypes % of DMT-treated patients 100% 90% 80% 77% 70% 60% 54% 50% 40% 30% 20% 13% 9% 8% 10% 5% 5% 5% 5% 5% 6% 2% 2% 3% 0% Platform injectable ag
Slide 45: Progressive MS Patients Are Not Achieving Optimal Treatment Outcomes
Despite High DMT Utilization, Progressive MS Patients Are Not Achieving Optimal Treatment Outcomes, With Only 37% Responding Well DMT Treatment Rate in the U.S. by MS Subtype DMT Treatment Response in PPMS % of patients 76% 74% 74% 14% 72% 72% 70% 37% 68% 21% 66% 65% 64% 64% 62% 60% 29% 58% Physicia
Slide 46: ~80% of Confirmed Disability Worsening in Progressive MS Occurs Independent of Relapses
~80% of Confirmed Disability Worsening in Progressive MS Occurs Independent of Relapses, Underscoring the Need for Therapies Targeting Neurodegeneration Sustained PIRA and RAW as a share of all 6-month CDW (%) 26.9 Full | RRMS 47.3 15.3 Full | SPMS % of all 6-month CDW events 76.7 3.1 Full | PPMS 83
Slide 47: Vidofludimus Calcium Combines Neuroprotective Effects Via Nurr1 With Anti-Inflammatory DHODH Inhibition
Vidofludimus Calcium Combines Potential Neuroprotective Effects Via Nurr1 Activation With Anti-Inflammatory Effects of Selective DHODH Inhibition Safety Neuroprotection/Anti-inflammation Potentially reduces key safety concerns Combines neuroprotective effects through associated with currently market
Slide 48: Vidofludimus Calcium Offers a Differentiated Approach in the Progressive MS Pipeline
Vidofludimus Calcium Offers a Differentiated Approach in the Progressive MS Pipeline Phase 3 Progressive MS Pipeline COMPANY PROGRAM MOA ROA PPMS SPMS Nurr1 activator / Vidofludimus Calcium Oral QD PPMS naSPMS Selective DHODH inhibitor Orelabrutinib BTKi Oral QD PPMS naSPMS PPMS Fenebrutinib BTKi Or
Slide 49: Current and Emerging Progressive MS Therapies Face Efficacy, Safety and Regulatory Challenges
Current and Emerging Progressive MS Therapies Face Important Efficacy, Safety and Regulatory Challenges Ocrevus® (ocrelizumab)1 Fenebrutinib2 Tolebrutinib3 PPMS PPMS nrSPMS Unresolved benefit-risk profile: Modest effect in a representative Uncertain incremental efficacy over Statistically significan
Slide 50: Progressive MS Represents a Multi-Billion-Dollar Global Market Opportunity
Progressive MS Represents a Multi-Billion-Dollar Global Market Opportunity With Significant Growth Potential United States Europe/UK ~175K diagnosed cases of SPMS and PPMS ~165K diagnosed cases of SPMS and PPMS ~115K SPMS and PPMS patients receiving DMTs ~58K SPMS and PPMS patients receiving DMTs Cu
Slide 51: Success in Relapsing and Progressive MS Could Position Vidofludimus Calcium for All MS Subtypes
Success Across Relapsing and Progressive MS Phase 3 Studies Could Position Vidofludimus Calcium as the Only DMT Indicated For All MS Subtypes Relapsing MS (Inflammatory Disease Activity) Progressive MS (Disability Accumulation) CIS RRMS aSPMS naSPMS PPMS (clinically isolated (relapsing-remitting (ac
Slide 52: A Phase 3 Win in Progressive MS Could Expand Peak Sales Potential in Relapsing MS
A Phase 3 Win in Progressive MS Could Also Significantly Expand Vidofludimus Calcium’s Peak Sales Potential in Relapsing MS ILLUSTRATIVE PEAK SALES OPPORTUNITY FOR VIDOFLUDIMUS CALCIUM Potential halo effect in relapsing MS (e.g., greater physician confidence, earlier use) Progressive MS (PPMS + naSP
Slide 53: Outlook: Upcoming Milestones for Vidofludimus Calcium in MS
Outlook: Upcoming Milestones for Vidofludimus Calcium in MS Erik Lundgren I Chief Executive Officer
Slide 54: Value Creation Roadmap
Value Creation Roadmap Multiple Catalysts Through 2030 2H 2026 2027 2028 Relapsing MS ENSURE-1 and ENSURE-2 Top-line data expected Targeted relapsing MS NDA Potential relapsing MS U.S. in December 2026 submission in mid-2027 regulatory approval in 2028 Progressive MS Initiation of Phase 3 trial Firs
Slide 55: Q&A Session
Q&A Session
Slide 56: Thank you!
Thank you! Jessica Breu Vice President Investor Relations & Communications Immunic, Inc. Immunic AG Immunic Australia Pty. Ltd. Phone: +1-332-255-9819 1200 Avenue of the Americas Lochhamer Schlag 21 Melbourne Email: [email protected] New York, NY 10036 82166 Gräfelfing (Munich) Australia Web: www.imux.com