Immunic (IMUX) 3rd Annual Guggenheim Healthcare Innovation Conference summary

ENSURE pivotal trials and near-term plans

• ENSURE-1 and ENSURE-2 are parallel Phase III trials totaling 2,221 patients; each tests once-daily vidofludimus calcium 30 mg vs placebo, with time to first relapse as the primary endpoint.

• Both trials are expected to read out in December; positive results could support an NDA filing for relapsing MS.

• An October 2024 IDMC review found the trials not futile and recommended continuing unchanged; the review occurred at about half the expected event rate.

• EMPhASIS Phase II showed a 42% relapse-risk reduction and a 76% reduction in gadolinium-enhancing lesions; management cited these findings as supportive of the Phase III program.

• Progression endpoints will be pooled across the trials; the hierarchical analysis places net clinical benefit, based on EDSS pairwise comparisons, at the top.

Vidofludimus calcium profile and differentiation

• The once-daily oral treatment combines DHODH inhibition for neuroinflammatory activity with Nurr1 activation, which management says supports neuronal repair, resilience and survival.

• Preclinical models showed neuronal-survival effects that disappeared when Nurr1 was knocked out; CALLIPER Phase II clinical findings on progression were described as encouraging but not confirmatory.

• The safety database covers ~3,500 patients, with some treated for up to seven years; management highlighted clean liver, infection and GI profiles to date.

• Vidofludimus calcium has a ~30-hour half-life and is out of the system in less than 10 days, vs teriflunomide's 16–19-day half-life and potential circulation for over two years.

• Management positioned the treatment as a potential differentiated oral option based on efficacy, safety, tolerability and convenience, including for patients switching after extended anti-CD20 use.

Commercial strategy and market opportunity

• Commercial preparations are underway, including hiring commercial leadership, building medical affairs and deploying medical science liaisons; successful December data would accelerate scaling.

• The plan is to launch independently in the U.S.; management targets an NDA filing in mid-2027 and a launch around mid-2028.

• U.S. relapsing MS is a $17 billion market today, projected to reach $25 billion in the 2030s; 300,000 patients currently receive disease-modifying therapy, with ~90,000 seeking a new option annually.

• Management estimated that 4%–5% market share could support $1 billion in sales; oral therapies account for ~25%–30% of prescriptions.