Company Overview - Immunic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral therapies for chronic inflammatory and autoimmune diseases[5] - The company's lead drug candidate, Vidofludimus Calcium, has a peak sales potential of $3-7 billion in Multiple Sclerosis (MS)[5] - As of June 30, 2025, Immunic had a cash balance of $55.3 million[5] Clinical Pipeline - Vidofludimus Calcium's Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) was successfully completed, showing a reduction in disability worsening[6] - The CALLIPER trial for Progressive Multiple Sclerosis (PMS) with Vidofludimus Calcium also showed substantial reductions in disability worsening[6] - Top-line data for the ENSURE trials (ENSURE-1 and ENSURE-2) in Relapsing Multiple Sclerosis (RMS) are expected by the end of 2026[6] Vidofludimus Calcium Efficacy - The EMPhASIS trial showed a 78% reduction in cumulative unique active (CUA) lesions and a 74% reduction in Gadolinium-enhancing (Gd+) lesions with the 45mg dose compared to placebo[44] - In the CALLIPER trial, Vidofludimus Calcium demonstrated a 24% risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population[94] - A 34% reduction of 24wCDW was observed in patients without baseline inflammatory lesions in the CALLIPER trial[95] Market Opportunity - The Multiple Sclerosis (MS) market is large and growing, with many brands generating over $1 billion in global annual sales in 2024[100] - The MS therapies market is currently a $20 billion market growing at 4% year-over-year[101] - Vidofludimus Calcium has a potential peak sales of $1-2 billion for Relapsing MS (RMS), $1-2 billion for non-active Secondary Progressive MS (naSPMS), and $2-3 billion for Primary Progressive MS (PPMS)[108]

CALLIPER Trial Results - Vidofludimus Calcium showed a 20% relative risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population compared to placebo [38, 89] - In the primary progressive multiple sclerosis (PPMS) subgroup, Vidofludimus Calcium demonstrated an even more prominent 30% relative risk reduction in 24wCDW compared to placebo [38, 89] - Patients without gadolinium-enhancing (Gd+) lesions at baseline experienced a 29% reduction in disability worsening with Vidofludimus Calcium [41, 42, 90] - Vidofludimus Calcium resulted in a 5% improvement in the annualized rate of whole brain atrophy compared to placebo at 24 months [49] - Vidofludimus Calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo at 24 months [49] - The volume of new/enlarging T2 lesions was 319% lower in the Vidofludimus Calcium group compared to the placebo group at month 24 [50, 52] Safety and Tolerability - The trial confirmed a favorable safety and tolerability profile for Vidofludimus Calcium, consistent with previous clinical trials, with similar frequencies of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in both treatment arms [56, 58, 90] Commercial Opportunity - The market for PPMS treatment is estimated to be over $6 billion, with a significant portion of diagnosed patients currently untreated [72, 74, 85] - Vidofludimus Calcium has a potential peak sales opportunity of $3-7 billion across relapsing MS (RMS), non-active secondary progressive MS (naSPMS), and PPMS indications [76, 80]