Immunic (IMUX) investor relations material

Pipeline overview and program updates

• ENSURE-1 and ENSURE-2 pivotal phase III trials in relapsing MS are fully enrolled, with over 2,200 patients randomized across 15 countries and top-line data expected by end of 2026.

• Vidofludimus calcium is being developed as a franchise for both relapsing and progressive MS, with a phase III study in progressive MS planned to initiate by year-end and additional programs (CALLIPER and phase III) in preparation for 2026.

• The company is transitioning to an MS-focused organization, leveraging experienced leadership and targeted hiring.

Clinical trial data and development milestones

• Phase II EMPhASIS study showed robust reduction in MRI lesions and encouraging relapse reduction, with 92.3% of patients CDW-free at 144 weeks in open-label extension.

• ENSURE phase III studies target early active relapsing MS populations, with endpoints aligned to regulatory expectations and interim futility analysis in October 2024 recommending continuation unchanged.

• Vidofludimus calcium demonstrated dual action: selective DHODH inhibition and direct Nurr1 activation, supporting both anti-inflammatory and neuroprotective effects.

R&D strategy and innovation priorities

• Focus on developing a differentiated oral MS therapy addressing both inflammation and neurodegeneration, targeting high unmet needs in relapsing and progressive MS.

• Emphasis on addressing both relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA), with ongoing efforts to develop sensitive biomarkers and clinical measures.

• Multi-layered IP strategy with 10 patent families, providing exclusivity for vidofludimus up to 2044 in the US.