Immunic, Inc. · NASDAQ:IMUX
Immunic — 41st Congress of ECTRIMS 2025
13 slides from Immunic's conference presentation, Sep 25, 2025
Slide 1: Efficacy and Safety of Vidofludimus Calcium in Progressive Multiple Sclerosis
f) Immunic Efficacy and Safety of Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, in Progressive Multiple Sclerosis
Slide 2: Disclosures
Disclosures R.J. Fox reports personal consulting fees from Astoria Biologica, Biogen, Bristol Myers Squibb, Cognito, EMD Serono, Galvani, Immunic, INmune Bio, Kiniksa, Novartis, Sanofi, Siemens, and TG Therapeutics. He has served on advisory committees for AB Science, Biogen, Immunic, Novartis, and
Slide 3: Objectives of CALLIPER Study & Mechanism of Action of Vidofludimus Calcium
Objectives of CALLIPER Study & Objectives * Conduct an exploratory Phase 2 trial of vidofludimus calcium in progressive multiple sclerosis Scientific Evaluate for signs of direct and indirect neuroprotection in progressive multiple sclerosis patients Clinical * Evaluate safety and tolerability 3 Exp
Slide 4: CALLIPER: Phase 2 Clinical Trial in Progressive Multiple Sclerosis
CALLIPER: Phase 2 Clinical Trial in Progressive Multiple Sclerosis Multicenter, Randomized, Double-Blind, Sek Main Treatment Period (Double-Blind Extension Placebo-Controlled Phase 2 Trial Period (Open-Label) Inclusion Criteria = Patients aged 18-65 years (inclusive) = EDSS score between 3.0 to 6.5
Slide 5: CALLIPER Population Characteristics at Baseline
CALLIPER Population Characteristics at Baseline Vidofludimus Calcium Placebo Total CALLIPER Overall Study 235 232 467 Disease Subtype = PPMS 77 (32.8%) 75 (32.3%) 152 (32.5%) = naSPMS 135 (57.4%) 133 (57.3%) 268 (57.4%) = asPMS 23 (9.8%) 24(10.3%) 47 (10.1%) EDSS at Baseline = Mean (Median) 5.2 (5.5
Slide 6: Patient Disposition Diagram and Reasons for Discontinuation
Screened Patient: yal by subject (n=8) Other reasons (r Randomized (n=467) Stratified for PMS subtype and EDSS at baseline Vidofludimus cal (n=235) Completed MT per per protocol per protocol (n=194; 94; Continued in Extended Treatment (n=313) Patient Disposition Diagram and Reasons for Discontinuati
Slide 7: Results for Primary and Key Secondary Endpoints
i Results for Primary and Key Secondary Endpoints Percent Brain Volume Change (PBVC) Re-Baselined at 6 Months —eVviders 6 2 18 24 Months Difference Rate VidoCa-Placebo: 4.7% at 30 months 95%Ci: -0.285-0.379; p-value 0.78 * + Other regional annualized brain atrophy rate differences between VidoCa-Pla
Slide 8: 24wCDW (EDSS) According to Gadolinium Lesions at Baseline
24wCDW (EDSS) According to Gadolinium Lesions at Baseline No Evident Effect of Gd+ at BL, Supporting Hypothesis of Clinical Neuroprotective Effects CALLIPER Overall Population os Patients Without Gd+ at BL —vidoca os — vidoca 2 lacebo 2 lacebo: 3 oa Placebs 3 oa Placebs 2 2 & os & os 5 o2 5 o2 5 5 2
Slide 9: Results for Exploratory Endpoints Related to Disability
Results for Exploratory Endpoints Related to Disability Change of Mean EDSS CALLIPER Overall Population MMRM Analysis (All Patients): Change from Baseline in EDSS score 0.38 os 028 Ls Mean of EDS 0.05 o 005 o 2 2 9% 864 GBC Weeks eVidotlugimus Caleium 2 Placebo + Statistically sgnificant(p<0.05) **
Slide 10: Safety and Tolerability Profile of 45 mg Vidofludimus Calcium
Safety and Tolerability Profile of 45 mg Vidofludimus Calcium CALLIPER Overall Population (Treatment-Emergent Adverse Events) Number of Patients With Any TEAE and SAE = No new safety signals identified N (%) of Patients Vidofludimus Calcium Placebo oo, = Occurrence of TEAEs and SAEs with similar WED
Slide 11: Liver Enzyme Elevations
Liver Enzyme Elevations No Evidence of Increased Rates of Liver Enzyme Elevations Elevations of Alanine Aminotransferase (ALT) Elevations of Aspartate Aminotransferase (AST) Vidofludimus Vidofludimus Calcium Rte Calcium ted ae (oo) (n=232) (eos (n=232) ALT>3xULN 7 (3.0%) 6 (2.6%) AST>3xULN 5 (2.2%)
Slide 12: Renal Events and Infections
Renal Events and Infections No Evidence of Increase in Incidences of Renal Events or Infections Adverse Events Renal and Urinary Disorders Adverse Events Infections and Infestations Vidofludimus Calci Placebo Placebo (n=235) (n=232) (n=232) N % N N % N N % N Patients | Patients| Events | Patients|Pa
Slide 13: Conclusions from Phase 2 CALLIPER Trial of Vidofludimus Calcium
Conclusions from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis No evident effect of vidofludimus calcium on whole brain atrophy in progressive MS patients. Although underpowered for disability outcomes, consistent trends were found on disability progression across