Immunic (IMUX) Stifel 2026 Virtual CNS Forum summary

2026 outlook and upcoming milestones

• 2026 is expected to be transformative, with phase III readouts for ENSURE-1 and ENSURE-2 studies in relapsing MS (RMS) anticipated at year-end.

• Preparations for a New Drug Application (NDA) submission are underway, planned for the following year.

Vidofludimus calcium: Mechanism and differentiation

• Designed as a safer, more selective DHODH inhibitor, avoiding kinase inhibition linked to side effects in similar drugs.

• Acts as a potent Nurr1 activator, providing unique neuroprotective and anti-inflammatory effects.

• Demonstrated a strong safety profile, with liver enzyme changes comparable to placebo and a short elimination half-life.

Safety and efficacy profile

• Avoids key side effects of existing therapies, such as hepatotoxicity and embryo-fetal toxicity, due to its selectivity and pharmacokinetics.

• Animal and clinical data suggest a differentiated safety profile, potentially reducing the need for certain safety warnings.