Immunic (IMUX) Earnings Call Presentation

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]