Immunic (IMUX) Investor presentation summary

Lead asset and milestones

• Vidofludimus calcium (IMU-838) combines direct Nurr1 activation with selective DHODH inhibition, targeting neurodegenerative and inflammatory pathways in relapsing and progressive MS.

• ENSURE-1 and ENSURE-2 are fully enrolled (N=2,221); top-line data are expected by year-end 2026, a U.S. NDA is targeted for mid-2027, and potential U.S. approval in 2028.

• Progressive MS Phase 3 initiation is expected later in 2026, following Phase 2 CALLIPER results.

• Funding is expected into late 2027; U.S. intellectual property protection is expected through 2044.

Clinical evidence

• In EMPHASIS, primary and key secondary MRI endpoints were statistically significant: CUA lesions at 45 mg vs. placebo, p=0.0002; at 30 mg vs. placebo, p<0.0001.

• In EMPHASIS, the 30 mg group had a 42% lower relative risk of relapse vs. placebo through week 24 (HR 0.58, p=0.19); the result was a trend, not statistically significant.

• In the open-label extension, 92.3% of patients were free of 12-week CDW at week 144 and 92.7% were free of 24-week CDW; 196 of 254 patients reached 144 weeks.

• CALLIPER did not meet its primary annualized PBVC endpoint (p=0.78); exploratory results included numerical reductions in CDW and an approximately twofold increase in CDI vs. placebo.

• At 45 mg in CALLIPER, TEAEs were 69.4% vs. 68.5% and SAEs 8.1% vs. 6.5% for placebo; no new safety signals were observed through 120 weeks.

Market opportunity

• The U.S. relapsing MS market is estimated at ~$17B in 2026 and projected to reach ~$25B by 2032; oral DMTs account for 28% of patient share.

• The U.S. has ~400,000 diagnosed relapsing MS patients, with 30–35% currently untreated; ~45,000 initiate therapy and ~45,000 switch each year.

• Progressive MS represents ~150,000 diagnosed U.S. patients; the long-term market opportunity is estimated at up to $12B.

• The proposed profile combines oral convenience with Nurr1-mediated neuroprotection and DHODH-mediated anti-inflammatory effects.