Immunic (IMUX) investor relations material

Pipeline overview and program updates

• Vidofludimus calcium is positioned as a differentiated oral therapy for both relapsing and progressive MS, with dual mechanisms targeting inflammation and neurodegeneration.

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

• Progressive MS program (CALLIPER and Phase III) is in preparation, with initiation expected later in 2026.

• The EMPhASIS Phase II study demonstrated robust lesion reduction and encouraging relapse outcomes, supporting advancement to Phase III.

Clinical trial data and development milestones

• Phase II EMPhASIS showed significant reduction in MRI lesions and a 42% reduction in relapse risk at the 30 mg dose, with 92.3% of patients CDW-free at 144 weeks in open-label extension.

• ENSURE-1 and ENSURE-2 Phase III studies target early active relapsing MS populations, with endpoints aligned with regulatory authorities and top-line data expected by end of 2026.

• High retention rates and favorable safety profile observed in open-label extension studies, with over 3,500 patients exposed to date.

• NDA submission is planned for mid-2027, contingent on positive Phase III results.

• 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 relapse-associated worsening and progression independent of relapse activity through dual Nurr1 activation and DHODH inhibition.

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

• Emphasis on listening to patient and clinician needs to guide development priorities.

• Plans to expand into progressive MS with a dedicated Phase III program.