Immunic (IMUX) investor relations material

Strategic and clinical program updates

• Anticipates Phase 3 data readouts for relapsing MS in the next year, with two major studies fully enrolled and progressing on schedule.

• Recent Phase 2 CALLIPER study in progressive MS showed a 34% reduction in disability worsening, the best result to date for this population.

• Statistically significant improvement in disability scores and confirmed disability improvement observed after 60 and 120 weeks in progressive MS.

• Plans for a Phase 3 progressive MS study are underway, likely requiring 800–900 patients and focusing on 24-week confirmed disability worsening as the primary endpoint.

• Unique neuroprotective mechanism via Nurr1 activation differentiates the therapy from existing immunosuppressive treatments.

Market positioning and competitive landscape

• Targets the oral disease-modifying therapy segment, representing 35–40% of MS prescriptions, with a focus on newly diagnosed and switch patients.

• Differentiation based on dual mechanism: neuroprotection and anti-inflammatory action, with a superior safety and tolerability profile compared to current orals.

• Positioned as a logical switch for patients discontinuing anti-CD20 therapies due to infection risk, representing a $500M–$1B opportunity in the US.

• BTK inhibitors are not seen as a threat due to lack of direct neuroprotection and expected liver toxicity monitoring requirements.

• The MS market is projected to grow to $30B, allowing room for multiple innovative therapies.

Financial outlook and partnership strategy

• Raised $65M in June, with potential for an additional $65M from warrants by year-end.

• Actively exploring partnerships to support clinical development and commercial launch, with ongoing discussions about optimal timing.

• Preparing for potential independent commercial launch, inspired by recent biotech analogs, while maintaining flexibility for strategic partnerships.