Immunic (NasdaqGS:IMUX) 2026 Conference Transcript

Summary of Immunic's Conference Call Company Overview - Company: Immunic - Product: Vidofludimus calcium - Focus: Treatment for multiple sclerosis (MS) Key Points Unique Mechanism of Action - Vidofludimus calcium activates Nurr1, a nuclear receptor involved in neuroprotection, which differentiates it from other MS treatments [4][7] - It also acts as a DHODH inhibitor, providing an established anti-inflammatory mechanism [4][7] Clinical Data and Efficacy - The EMPHASIS study showed: - 76% reduction in cumulative active lesions - 78% reduction in gadolinium-enhancing lesions [20] - A numerical reduction of disability progression (CDW) by over 50% in the phase 2 study [14] - Safety and tolerability were comparable to placebo, indicating a favorable profile [21] Comparison with Other Treatments - Current oral therapies show efficacy rates of 30%-50% for glatiramer acetate and Aubagio, while anti-CD20 therapies show 80%-90% [22][24] - Vidofludimus calcium aims to provide a better benefit-risk profile, especially for patients who cannot tolerate existing therapies [43] Market Opportunity - The oral therapy market represents 35%-40% of total prescriptions for MS [77] - An estimated 5%-10% of patients on anti-CD20 therapies may need to switch due to serious infections, representing a potential $1 billion market in the U.S. alone [80][81] - The average cost of branded oral therapies is projected to be around $120,000 WAC at launch [85] Phase 3 Studies - The ENSURE studies for relapsing MS are fully enrolled, with primary endpoints focused on time to first relapse and secondary endpoints including MRI biomarkers and disability progression [57][58] - Expected readout for the studies is at the end of the year [62] Progressive MS Treatment - Immunic is also targeting primary progressive MS (PPMS) with a phase 2 study showing a 31% reduction in disability progression [112][113] - The potential market for PPMS is significant, with Roche's Ocrevus generating over $3 billion in sales from this segment [151] Safety Profile - Vidofludimus calcium has shown a clean safety profile with low rates of adverse events compared to existing therapies [46][48] - No significant liver enzyme changes were observed, differentiating it from other DHODH inhibitors [54] Future Outlook - Immunic plans to initiate pivotal studies for PPMS, with expectations of replicating positive data from previous studies [155] - The company believes it has a differentiated asset that could capture significant market share in both relapsing and progressive MS [161] Conclusion - Immunic is positioned to address unmet needs in the MS market with vidofludimus calcium, focusing on both relapsing and progressive forms of the disease, while emphasizing safety and tolerability as key differentiators [161]