Immunic (IMUX) Piper Sandler 36th Annual Healthcare Conference summary

Key milestones and clinical data outlook

• Major catalysts expected in 2025 and 2026, with CALLIPER phase 2 data in April 2025 and ENSURE-1/2 phase 3 data in 2026.

• CALLIPER targets progressive MS, focusing on neuroprotection and disability worsening, with top-line data to be released directly upon availability.

• ENSURE-1 and ENSURE-2 studies in relapsing MS are expected to complete in Q2 and H2 2026, respectively.

• Both studies aim to demonstrate efficacy in slowing disability progression and offer a differentiated safety profile.

Study design, endpoints, and regulatory strategy

• CALLIPER includes 467 patients across three progressive MS forms, with brain atrophy as the primary and disability worsening as a key secondary endpoint.

• A 15% placebo-adjusted slowdown in disability worsening is considered a meaningful success; 20% or higher would further support phase 3 advancement.

• A single pivotal phase 3 study is expected for regulatory approval in progressive MS, with typical sample sizes of 800–1,000 and a three-year duration.

• Expedited approval pathways may be discussed post-phase 2, but the base case remains a full phase 3 program.

Market potential, differentiation, and intellectual property

• Non-active secondary progressive MS represents the largest unmet need, with a market potential of $1–2 billion.

• The drug's dual mechanism (DHODH inhibition and Nurr1 activation) and favorable safety profile position it as a potential best-in-class MS therapy.

• Patent portfolio includes eight families, with protection expected through at least 2041, and potentially to 2044 with recent filings.

• Strong IP and broad activity support future partnership and M&A discussions.