Immunic (IMUX) Investor presentation summary

Strategic focus and lead asset

• Transitioning to a fully integrated multiple sclerosis (MS) company with a focus on both relapsing and progressive MS.

• Lead asset vidofludimus calcium (IMU-838) is an oral therapy with dual mechanisms: Nurr1 activation and selective DHODH inhibition, targeting neurodegeneration and inflammation.

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

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

• Intellectual property protection in the U.S. expected up to 2044, with funding into late 2027.

Market opportunity and commercial strategy

• MS is a large and growing market, with global annual sales projected to exceed $30 billion by the early 2030s.

• Multiple blockbuster therapies coexist due to the heterogeneous nature of MS and frequent therapy switching.

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

• A differentiated oral therapy could capture 4-5% of the U.S. relapsing MS market, generating blockbuster sales.

• Commercial strategy phases: establish foundation in relapsing MS (2026-2028), scale and generate cash flow (2028-2032), and expand into progressive MS for long-term leadership.

Clinical development highlights

• Vidofludimus calcium demonstrated robust reduction in MRI lesion activity and favorable safety in Phase 2 EMPHASIS trial for relapsing-remitting MS.

• Open-label extension showed high retention and 92.3% of patients free of confirmed disability worsening at 144 weeks.

• Phase 3 ENSURE trials are designed to confirm immunomodulatory effects, with primary endpoint of time to first relapse and key secondary MRI endpoints.

• In progressive MS, Phase 2 CALLIPER trial showed favorable trends in MRI and disability endpoints, supporting a Phase 3 program.

• Safety profile at 45 mg dose in progressive MS was favorable, with no new safety signals and no Hy's Law cases observed.