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Immunic (NasdaqGS:IMUX) Earnings Call Presentation
2026-02-20 12:00
Immunic Therapeutics Developing Selective Oral Therapies in Immunology NASDAQ: IMUX | February 2026 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 Exchange Act of 1934, as amended. These include statements regarding management's intentions, plans, beliefs, e ...
Immunic (IMUX) FY Earnings Call Presentation
2025-09-08 11:00
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]
Immunic (IMUX) Earnings Call Presentation
2025-05-02 08:05
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]