Immunic (IMUX) 2025 Conference Transcript

Summary of Immunic (IMUX) Conference Call Company Overview - Company: Immunic (IMUX) - Focus: Clinical stage company developing oral treatments for chronic inflammation and autoimmune diseases, particularly multiple sclerosis (MS) [2][3] Key Points on Multiple Sclerosis (MS) Treatment - Market Opportunity: Immunic targets a significant commercial opportunity with peak sales potential estimated between $3 billion to $7 billion across various forms of MS [3][9] - Pipeline: - Beta Frutimous Calcium: In phase three for relapsing MS (RMS) and recently completed phase two for progressive MS (PMS) [3][9] - IMU 856: Targeting gastrointestinal diseases, specifically celiac disease [4][26] Beta Frutimous Calcium - Mechanism of Action: - Acts as a potent inhibitor of DHODH, reducing inflammation and preventing neurodegeneration [4][5] - Activates NurOwn, a nuclear receptor that protects neurons from cell death [5][10] - Clinical Data: - Phase two study (EMPHASIS) showed a 76% reduction in active lesions and a 94.2% rate of patients free from confirmed disability worsening after two years [12][13] - Phase two study (CALIPER) demonstrated a 24% reduction in confirmed disability worsening overall, with 33% in primary progressive MS (PPMS) patients [19][20] - Notably effective in patients without active inflammation, showing a 34% reduction in disability worsening [22][24] Unmet Medical Need - Current Treatments: Only one drug approved for primary progressive MS, highlighting a significant unmet need in the market [16][15] - Patient Population: Approximately 1.2 million eligible patients for MS treatment globally, with many not currently receiving therapy [8][16] Key Points on IMU 856 - Mechanism: A selective modulator targeting epithelial regeneration in the gut, potentially applicable to various gastrointestinal disorders [26][28] - Clinical Data: - Phase one study showed a significant increase in GLP-1 levels (up to 250%) in celiac disease patients, indicating potential for managing weight gain and gut health [31][32] - Demonstrated protection of gut villi and improved nutrient absorption in a short-term study [35][36] Safety and Tolerability - Beta Frutimous Calcium: Favorable safety profile with no new safety findings reported, making it an attractive option for newly diagnosed MS patients [23][14] - IMU 856: Safety and tolerability assessed in clinical studies, with promising results [30][34] Future Outlook - Next Steps: Anticipation of top-line data from phase three studies by the end of 2026, with potential NDA submission in 2027 if results are positive [25][37] - Market Positioning: Immunic aims to position Beta Frutimous Calcium as a unique oral treatment option for all forms of MS, addressing both relapsing and progressive forms [37]