Immunic (IMUX) investor relations material

Near-term clinical catalysts

• ENSURE-1 and ENSURE-2 Phase III pivotal trials in relapsing MS are expected to read out in December; positive results would be NDA filing-enabling.

• EMPhASIS Phase II showed a 78% reduction in Gd-enhancing lesions and a 42% point-estimate reduction in relapse risk; the relapse result was not statistically significant.

• Management expects relapse reduction in the ~30% range in Phase III, with supporting MRI and safety/tolerability data.

• Progression endpoints from the two RMS trials will be pooled; management expects a numerical advantage but noted the 18-month studies are not built or powered to assess progression.

Differentiated profile and market opportunity

• Vidofludimus calcium is positioned as a potential first neuroprotective MS treatment, with neuroinflammatory and neurodegenerative mechanisms and a Nurr1-based progression thesis.

• The safety database covers 3,500 patients; targeted differentiators include liver safety, serious or opportunistic infections, acute tolerability symptoms and alopecia.

• Target segments include oral-preferring patients (25%-30% of prescriptions), anti-CD20 switchers and older patients; 25% of anti-CD20 users, or 40,000 patients, are seeking to discontinue or using extended-interval dosing.

• Claims analysis indicates 40%-50% of U.S. relapsing MS patients are 55 or older; management sees differentiated treatment needs in this population.

• A targeted launch would focus on ~3,000 clinicians writing 80% of prescriptions, with a smaller sales force than the 200-300-rep model used historically and support from other field roles.

Access and competitive positioning

• Oral MS DMTs average ~$115,000 in WAC pricing with ~30% gross-to-net; branded products have over 90% plan coverage, and branded/generic use is roughly evenly split where generics compete.

• Typical access includes specialty-category placement, specialist prescribing, prior authorization and failure of one or two prior therapies; management expects limited requirements to fail generic teriflunomide first.

• Management sees room for vidofludimus calcium and remibrutinib to compete, citing infection, bleeding and drug-interaction considerations with remibrutinib for some patient segments.