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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
Immunic Therapeutics Positive Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis NASDAQ: IMUX | April 30, 2025 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 r ...