Immunic (IMUX) Investor presentation summary

Strategic focus and lead asset

• Transitioning to a fully integrated multiple sclerosis (MS) company, advancing vidofludimus calcium (IMU-838), an oral therapy with dual mechanisms targeting both neurodegeneration and inflammation in MS.

• Phase 3 ENSURE-1 and ENSURE-2 trials for relapsing MS are fully enrolled, with top-line data expected by end of 2026 and a U.S. NDA submission targeted for mid-2027.

• Expansion into progressive MS is planned, supported by Phase 2 CALLIPER data showing numerical reductions in disability worsening and signals for improvement.

• Intellectual property protection in the U.S. is expected through 2044, with funding secured into late 2027.

Market opportunity and commercial strategy

• The global MS market is projected to exceed $30 billion annually by the early 2030s, with multiple blockbuster therapies coexisting due to high unmet needs and patient heterogeneity.

• U.S. relapsing MS market offers growth via newly diagnosed, switching, and untreated patients, with ~90,000 patients seeking new treatment annually.

• A phased commercial strategy aims to establish a foundation in relapsing MS, scale through 2028-2032, and expand into progressive MS for long-term value.

• Capturing 4-5% of the U.S. relapsing MS market could generate blockbuster sales.

Clinical development and efficacy

• Vidofludimus calcium demonstrated robust reductions in MRI lesion activity and favorable trends in relapse risk in Phase 2 EMPHASIS trial for relapsing-remitting MS.

• High retention and low progression rates observed in open-label extension, with 92.3% of patients CDW-free at 144 weeks.

• In progressive MS, Phase 2 CALLIPER trial showed consistent numerical reductions in disability worsening and a two-fold increase in disability improvement versus placebo, even in non-active patients.

• Exploratory MRI outcomes in progressive MS favored vidofludimus calcium, including reduced thalamic atrophy and lesion burden.