Immunic, Inc. · NASDAQ:IMUX
Immunic — Investor Day (September 2026)
58 slides from Immunic's investor day presentation, Sep 9, 2026
Slide 1: Relapsing Multiple Sclerosis R&D Day
Relapsing Multiple Sclerosis R&D Day September 9, 2026 Virtual NASDAQ: IMUX © Immunic, Inc. | Sep 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: Virtual Relapsing Multiple Sclerosis R&D Day: Today's Speakers
Virtual Relapsing Multiple Sclerosis R&D Day: Today’s Speakers Immunic Speakers Featured Experts Erik Lundgren, MBA Jason Tardio, MBA Amit Bar-Or, MD, FRCPC Stephen Krieger, MD, FAAN Chief Executive Officer President & Chief Operating Officer Department of Neurology, Perelman School Department of Ne
Slide 4: Agenda Virtual Relapsing Multiple Sclerosis R&D Day
Vidofludimus Calcium – Unique Potential to Transform the MS Treatment Landscape Agenda Virtual Relapsing Multiple Sclerosis R&D Day Erik Lundgren 11:00 - 11:05 Welcome and Introduction Chief Executive Officer Expert Talk: Multiple Sclerosis: Targeting Novel Mechanisms Amit Bar-Or, MD, FRCPC 11:05 -
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 Top-line data for both Relapsing MS Both trials fully Calcium trials expected by e
Slide 8: Vidofludimus Calcium Has the Potential to Transform the MS Market
Vidofludimus Calcium Has the Potential to Transform the MS Market Substantial Opportunities: MS Remains a Large and Growing Market Attractive Market Dynamics ▪ Multiple blockbuster therapies can successfully coexist, reflecting the large patient BLOCKBUSTER POTENTIAL population, heterogenous disease
Slide 9: Expert Talk: Amit Bar-Or, MD, FRCPC
Expert Talk: Amit Bar-Or, MD, FRCPC Department of Neurology, Perelman School of Medicine, University of Pennsylvania
Slide 10: Vidofludimus Calcium's Dual Mode of Action: Benefits Beyond Traditional Anti-Inflammatory Treatment
Vidofludimus Calcium's Dual Mode of Action: Benefits Beyond Traditional Anti-Inflammatory Treatment Hella Kohlhof, PhD I Co-Founder & Chief Scientific Officer
Slide 11: Vidofludimus Calcium: A Unique Dual Mechanism Approach to MS
Vidofludimus Calcium: A Unique Dual Mechanism Approach to MS Potentially the Only Oral MS Drug Addressing Both PIRA and RAW Simultaneously Direct Nurr1 Activator Selective DHODH Inhibitor ▪ Modulates gene expression directly in ▪ Selectively targets neurons, mediating neuroprotection metabolically h
Slide 12: Vidofludimus Calcium is a Selective DHODH Inhibitor
Vidofludimus Calcium is a Selective DHODH Inhibitor Selectively inhibits DHODH Vidofludimus does not inhibit kinases in a panel of 94 DHODH IC50 in nM human kinases Human Murine Rat Vidofludimus 240 5100 1000 Whereas teriflunomide targets Teriflunomide 1700 300 4 PIM, Aurora A, PDGFR, EGFR* Reduces
Slide 13: … and a Potent Nurr1 Activator – Relevant in MS Biology and Neuroprotection
… and a Potent Nurr1 Activator – Relevant in MS Biology and Neuroprotection → Nurr1 regulates neuronal survival, oxidative stress responses, and neuroinflammatory signaling.1 → Reduced Nurr1 expression in RRMS is associated with higher relapse rate and EDSS.2 → Nurr1 expression normalizes during pre
Slide 14: Vidofludimus Calcium Directly Binds to Nurr1
Vidofludimus Calcium Directly Binds to Nurr1 ITC DSF I S O T H E R M A L T I T R AT I O N C A L O R I M E T R Y DI FFER ENTI AL S CAN NING FLUOR IME TRY ΔTM (melting temperature) shifts indicate ligand-Nurr1 interaction Vidofludimus calcium induces a ΔTM shift Vidofludimus Calcium → Binding signal d
Slide 15: Nurr1-Associated Gene Expression by Vidofludimus Calcium
Nurr1-Associated Gene Expression by Vidofludimus Calcium Vidofludimus calcium increased expression of selected Nurr1-regulated genes involved in neuronal function in different cell types. Performed at LMU, Munich, Daniel Merk and City of Hope, USA, Zuoming Sun © Immunic, Inc. | Sep 2026 15 Nurr1: nu
Slide 16: Vidofludimus Calcium Improved Neuronal Survival and Reduced Injury Under Apoptotic Stress
Vidofludimus Calcium Improved Neuronal Survival and Reduced Injury Under Apoptotic Stress (TNFα+CHX Model) Neuronal Neuronal survival injury marker (NfL) TNF⍺+CHX Vido → → Vidofludimus calcium was associated with improved neuronal survival and reduced NfL release under apoptotic stress in N2A cells.
Slide 17: Vidofludimus-Associated Improved Neuronal Survival Requires Nurr1
Vidofludimus-Associated Improved Neuronal Survival Requires Nurr1 TNF⍺+CHX 6-OH DA Control Nurr1 KO Control Nurr1 KO CRISPR-mediated Nurr1 knockout 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 18: Vidofludimus Calcium Increased Neuronal Viability Under Neuroinflammatory Condition
Vidofludimus Calcium Increased Neuronal Viability Under Neuroinflammatory Condition (Neuron-Microglia Co-Culture) Neuron-microglia co-culture Neurons alone control LPS+IFNg Vido → → Vidofludimus calcium was associated with increased neuronal viability in inflammatory co-culture. Performed at City of
Slide 19: Vidofludimus Calcium Reduced Disease Severity in EAE
Vidofludimus Calcium Reduced Disease Severity in EAE Vehicle Vido 150 mg/kg Prophylactic Prophylactic Therapeutic Vidofludimus calcium reduced clinical disease severity in both prophylactic and therapeutic EAE models. Performed at City of Hope, USA, Zuoming Sun © Immunic, Inc. | Sep 2026 19 EAE: exp
Slide 20: Vidofludimus Calcium Modulated Nurr1-Related Gene Expression in CNS
Vidofludimus Calcium Modulated Nurr1-Related Gene Expression in CNS BRAI N SPI NAL CORD Vehicle Vido 150 mg/kg Vidofludimus calcium treatment was associated with modulation of Nurr1-related gene expression in CNS tissue, in both prophylactic and therapeutic EAE settings. Performed at City of Hope, U
Slide 21: Vidofludimus Calcium Modulated Neurotrophic and Neuroaxonal Markers in EAE
Vidofludimus Calcium Modulated Neurotrophic and Vehicle Neuroaxonal Markers in EAE Vido 150 mg/kg BDNF NFL Vidofludimus calcium treatment was associated with increased plasma BDNF and reduced NfL levels in both prophylactic and therapeutic settings.* Performed at City of Hope, USA, Zuoming Sun * Dat
Slide 22: Is Every DHODH Inhibitor a Nurr1 Agonist? – NO!
Is Every DHODH Inhibitor a Nurr1 Agonist? – NO! ITC DSF I S O T H E R M A L T I T R AT I O N C A L O R I M E T R Y DI FFER ENTI AL S CAN NING FLUOR IME TRY ΔTM (melting Vidofludimus Calcium temperature) shifts → Binding signal detected indicate ligand-Nurr1 interaction Vidofludimus calcium induces a
Slide 23: 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 test system, teriflunomide did not significantly improve survival of neuronal cells. Performed at City of Hope, USA, Zuoming Sun © Immunic, Inc. | Sep 2026 23 TNF: tumor necrosis factor; CHX
Slide 24: 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 25: Ongoing Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing MS
Ongoing Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing MS Michael A. Panzara, MD, MPH I Chief Medical Officer
Slide 26: Even with 20+ Approved DMTs, Significant Unmet Needs Exist
Vidofludimus Calcium in Relapsing MS: Even with 20+ Approved DMTs, Significant Unmet Needs Exist Relapsing MS “ I was disappointed when I was told I was now too old to continue with any of these drugs, and I now feel lost. ” ~400K Diagnosed Patients in the U.S.1,2 “ Fatigue and cognitive issues are
Slide 27: Current DMTs Target Inflammation, None Stop/Reverse Disability Accumulation
Current DMTs Target Inflammation, None Stop/Reverse Disability Accumulation 20+ Therapies Exist for Relapsing MS, None Adequately Address the Neurodegeneration Driving Progression EDSS Disease Trajectory Over Time Bedridden / 9–10 Death from MS focal i nflam ma tion Wheelchair restricted 7–8 Disabil
Slide 28: EMPhASIS: Strong Efficacy, Durable Long-Term Benefit, and Favorable Safety and Tolerability in RRMS
EMPhASIS: Strong Efficacy, Durable Long-Term Benefit, and Favorable Safety and Tolerability in Relapsing-Remitting MS Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial (NCT03846219) 268 patients in 36 centers across four European countries Screening Main Treatment Peri
Slide 29: Robust Reduction in MRI Lesion Activity Over 24 Weeks
Robust Reduction in MRI Lesion Activity Over 24 Weeks Primary and Key Secondary Endpoints Both Highly Statistically Significant, Pooled Cohorts 1&2 Reduction in CUA Lesions up to Week 24 Reduction in Gd+ Lesions up to Week 24 0 0 0 7 0 5 0 -13% -10 -10 6 -20 4 -20 5 -30 -30 4 -40 3 -40 -50 -50 3 -60
Slide 30: Encouraging Trend on Risk of Relapse, Despite Study Size and Duration
Encouraging Trend on Risk of Relapse, Despite Study Size and Duration . Relative risk of relapse reduced by 42% Proportion of patients with relapse HR: HR: 0.58, 0.58 p=0.19 (HR: 0.58, p=0.19) in 30 mg group vs. . placebo to Week 24 23% Apparent onset of effect within 6-8 weeks, . increasing over ti
Slide 31: Favorable Safety and Tolerability Profile with Similar Incidence to Placebo
Favorable Safety and Tolerability Profile with Similar Incidence to Placebo Vidofludimus Vidofludimus Safety and Tolerability Endpoints Placebo Calcium 30 mg Calcium 45 mg Key Safety Observations: Any treatment-emergent adverse event 44% 45% 41% ▪ No signal for liver injury Treatment-emergent advers
Slide 32: Open-Label Extension Phase: High Retention Rate with 92.3% of Patients CDW-Free at 144 Weeks
Open-Label Extension Phase: High Retention Rate with 92.3% of Patients CDW- Free at 144 Weeks 100.0% 98.0% 97.2% 100% 94.6% 93.3% 93.3% 92.3% 90% › At week 144, 92.3% of patients % Patients Free of 12wCDW Events 80% remained free of 12-week CDW, with 70% 92.7% free of 24-week CDW 60% 50% › Low disco
Slide 33: ENSURE Phase 3: Two Fully Enrolled Pivotal Trials Designed to Confirm Immunomodulatory Effects
ENSURE Phase 3: Two Fully Enrolled Pivotal Trials Designed to Confirm Immunomodulatory Effects Specifically Through Relapse Reduction Randomized, Double-Blind, Placebo-Controlled Trials (NCT05134441 & NCT05201638) Screening OLE (optional) Main Treatment Period (Blinded) Period ▪ More than 100 sites
Slide 34: Countries and Inclusion/Exclusion Criteria of ENSURE Selected to Enable Recruitment
Countries and Inclusion/Exclusion Criteria of ENSURE Selected to Enable Recruitment of Early, Active Patient Population Into Placebo Controlled Trials Distribution of Clinical Trial Sites4 Key Inclusion Criteria ▪ Patients aged 18 to 55 years ENSURE-1: Number of Active Sites ENSURE-2: Number of Acti
Slide 35: Recruited Patients in ENSURE Similar to Population Recruited into EMPhASIS
Recruited Patients in ENSURE Similar to Population Recruited into EMPhASIS Total of 2,221 Enrolled Patients, Nearly 50% Received Prior MS Treatment ENSURE Baseline Patient Characteristics 1 EMPhASIS Baseline Patient Characteristics ENSURE-1 (N=1,121) ENSURE-2 (N=1,100) EMPhASIS (N=249) 2 Mean age (S
Slide 36: Primary and Secondary Endpoints Selected to Ensure Robust Assessment of Clinical and Imaging Outcomes
Primary and Secondary Endpoints Selected to Ensure Robust Assessment of Clinical and Imaging Outcomes Meaningful to People with MS ENSURE-1 Pooled ENSURE Trials ENSURE-2 “ I hope to see different kinds of MS drugs: ones that stop Primary Primary Time to First Relapse (TTFR) Net Clinical Benefit Time
Slide 37: Vidofludimus Calcium in Relapsing MS: Targeted NDA Submission Driven by Near-Term Pivotal Readouts
Vidofludimus Calcium in Relapsing MS: Targeted NDA Submission Driven by Near-Term Pivotal Readouts › Fully enrolled Phase 3 ENSURE-1 and Robust Phase 2 EMPhASIS Results on Inflammatory Endpoints ENSURE-2 trials with top-line data expected by year-end 2026 › NDA submission in the U.S. targeted for Ph
Slide 38: Expert Talk: Stephen Krieger, MD, FAAN
Expert Talk: Stephen Krieger, MD, FAAN Department of Neurology, Icahn School of Medicine, The Mount Sinai Hospital
Slide 39: Positioning and Commercial Opportunity for Vidofludimus Calcium in Relapsing MS
Positioning and Commercial Opportunity for Vidofludimus Calcium in Relapsing MS Jason Tardio I President & Chief Operating Officer
Slide 40: Even With 20+ Approved Therapies, Significant Unmet Needs Remain in Relapsing MS
Even With 20+ Approved Therapies, Significant Unmet Needs Remain in Relapsing MS PIRA1,2 Better Safety3,4 Improved Tolerability3,5,6 ▪ PIRA begins early in relapsing MS and ▪ Many DMTs carry meaningful safety ▪ Tolerability is a top patient priority when becomes an increasingly important driver trad
Slide 41: The U.S. Relapsing MS Market is Large, Continues to Grow, and Oral DMTs Remain a Sizable Class
The U.S. Relapsing MS Market is Large, Continues to Grow, and Oral DMTs Remain a Sizable Class ~7% CAGR Total U.S. Relapsing MS Patient Share by Class2 ~$25B 51% anti-CD20 ~$17B 28% Orals 2025 13% Platform injectables 8% Other high-efficacy mAbs 2026 2032 Sales numbers in G7 countries (U.S., UK, Can
Slide 42: Not a Winner Take All Market: ~90K U.S. Patients Making a Treatment Decision Each Year
Not a Winner Take All Market: Dynamic with ~90K U.S. Patients Making a Treatment Decision Each Year, with Another ~125K Currently Untreated THE RELAPSING MS PATIENT JOURNEY CREATES MULTIPLE TREATMENT DECISION POINTS relapsing MS patients initiate ~45K therapy each year1 01 02 03 04 INI TI ATE SWITCH
Slide 43: MS Treatment Is Highly Personalized for Each Patient and Influenced by Patient Preference and HCP Philosophies
MS Treatment Is Highly Personalized for Each Patient and Influenced by Both Patient Preference and MS Treatment Philosophies by HCPs MS Treaters Are Highly Heterogeneous with Diverse Personalized by Patient Characteristics1,2 Treatment Philosophies and Prescribing Behaviors 1,2 Disease Severity Age
Slide 44: HCPs Weigh the Overall Benefit-Risk Profile When Selecting DMTs, with Safety the Most Important
HCPs Weigh the Overall Benefit-Risk Profile When Selecting DMTs, with Safety the Most Important Product Attribute TREATMENT ATTRIBUTES THAT ARE MOST IMPORTANT TO HCPs Direct assessment of product attribute importance by HCPs rating on a 9-point scale Bandari D, et al., J Med Econ. 2023 Jan-Dec;26(1)
Slide 45: Patients Also Weigh the Overall Benefit-Risk Profile, with Side Effects as the Top Driver of Selection
Patients Also Weigh the Overall Benefit-Risk Profile, with Side Effects as the Top Driver of Selection TREATMENT ATTRIBUTES THAT ARE MOST IMPORTANT TO PATIENTS 60 51.4% 50 40 % relative importance 30 19.4% 20 14.3% 11.5% 10 1.0% 2.3% 0 Mode and frequency of Prevent relapses Delay progression Side ef
Slide 46: Vidofludimus Calcium Is Targeted to Deliver the Optimal Balance of Treatment Attributes
Vidofludimus Calcium Is Targeted to Deliver the Optimal Balance of the Treatment Attributes That Matter Most to Patients and HCPs Safety Neuroprotection/Anti-inflammation Potentially reduces key safety concerns Combines neuroprotective effects through associated with currently marketed DMTs, Nurr1 a
Slide 47: Vidofludimus Calcium Could Address Several Large, Underserved Relapsing MS Patient Segments
Vidofludimus Calcium Could Address Several Large, Underserved Relapsing MS Patient Segments Treated Relapsing Addressable Patient Segments for Size of Opportunity MS Patients Vidofludimus Calcium Relapsing MS Patients who Patients seeking ~100K relapsing MS ▪ A favorable risk-benefit Patients who co
Slide 48: Vidofludimus Calcium May Offer an Effective, Safe and Well-Tolerated Oral Option
Vidofludimus Calcium May Offer an Effective, Safe and Well-Tolerated Oral Option That Can Support Adherence and Long-Term Disease Management ~25% ~30% of relapsing MS patients starting of relapsing MS patients start on an oral DMT will discontinue on an oral DMT within one year 2,3 ~100K relapsing M
Slide 49: Vidofludimus Calcium May Offer a Non-Immunosuppressant DMT for Anti-CD20 Patients
Vidofludimus Calcium May Offer a Non-Immunosuppressant DMT for Anti- CD20 Patients Who Cannot Tolerate Anti-CD20 or Need to Sequence Away ~15% ~18% ~15% of anti-CD20 patients use of anti-CD20 patients switch of anti-CD20 patients will extended interval dosing1 away from an anti-CD201 discontinue wit
Slide 50: Vidofludimus Calcium May Offer a Differentiated Option for Older Relapsing MS Patients
Vidofludimus Calcium May Offer a Differentiated Option for Older Relapsing MS Patients as Age-Related Safety Considerations Reshape Treatment Priorities In older relapsing MS patients, immunosenescence and ~47% comorbidities can increase infection risk and reduce the suitability of prolonged high-ef
Slide 51: Key Takeaways: Vidofludimus Calcium Has the Potential to Address Significant Opportunities in Relapsing MS
Key Takeaways: Vidofludimus Calcium Has the Potential to Address Significant Opportunities in Relapsing MS LARGE AND GROWING MARKET NOT A WINNER-TAKE-ALL MARKET 1 The U.S. relapsing MS market is ~$17B today and projected to reach ~$25B by 2032, with oral DMTs remaining a significant treatment class
Slide 52: Outlook: Upcoming Milestones for Vidofludimus Calcium in MS
Outlook: Upcoming Milestones for Vidofludimus Calcium in MS Erik Lundgren I Chief Executive Officer
Slide 53: Multi-Layered Intellectual Property (IP) Strategy Approach
Multi-Layered Intellectual Property (IP) Strategy Approach Exclusivity for Vidofludimus Expected up to 2044 in the US Multi-layered IP strategy approach with 10 independent patent families to effectively protect vidofludimus (free acid and salts) with Orange Book listable patents up to 2044 in the U
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. by end of 2026 submission in mid-2027 regulatory approval in 2028 Progressive MS Progressive MS Phase 3 CALLIPER an
Slide 55: Building a Leading MS Company: A Phased Commercial Strategy
Building a Leading MS Company: A Phased Commercial Strategy U.S. Relapsing MS Opportunity to Build a Profitable, Fully Integrated Commercial Organization Serves as Platform for Long-Term Global Leadership in MS BECOME A GLOBAL MS LEADER (2032+) SCALE & GENERATE CASH FLOW Capture a substantially larg
Slide 56: Sneak Preview: Virtual Progressive MS R&D Day
Sneak Preview: Virtual Progressive MS R&D Day November 5, 2026 12:30 pm ET
Slide 57: Q&A Session
Q&A Session
Slide 58: 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: ir@imux.com New York, NY 10036 82166 Gräfelfing (Munich) Australia Web: www.imux.com