Immunic Highlights 2025 Accomplishments and Upcoming Milestones

Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][2][6] - Phase 2 CALLIPER data demonstrated that vidofludimus calcium significantly reduced 24-week confirmed disability worsening (CDW) and increased 24-week confirmed disability improvement (CDI) across progressive multiple sclerosis (PMS) and its subtypes, highlighting the drug's neuroprotective mechanism [1][2][6] - Long-term open-label data from the Phase 2 EMPhASIS trial showed low rates of confirmed disability worsening events in patients with relapsing-remitting multiple sclerosis (RRMS), indicating favorable long-term safety and tolerability [1][2][6] - The company received a U.S. patent for dose strengths of vidofludimus calcium in PMS, extending intellectual property protection until 2041 [1][2][6] Vidofludimus Calcium Highlights - Enrollment completed for ENSURE-1 with 1,121 patients and ENSURE-2 with 1,100 patients across over 100 sites in 15 countries [6] - Positive results from the CALLIPER trial showed statistically significant improvements in 24wCDI and reductions in thalamic atrophy and new or enlarging T2 lesion volume compared to placebo [6] - At week 144 of the EMPhASIS trial, 92.3% of patients remained free of 12wCDW and 92.7% free of 24wCDW, with no new safety signals reported [6] IMU-856 Highlights - IMU-856 demonstrated a dose-dependent increase in endogenous glucagon-like peptide-1 (GLP-1) levels and a reduction in body weight gain in preclinical testing, indicating potential for weight management [6] - The company is preparing for further clinical testing of IMU-856, contingent on financing, licensing, or partnering [6] Corporate Developments - Immunic closed a $5.1 million registered direct offering and an oversubscribed $65 million underwritten public offering [6] - The company will host one-on-one meetings at the 44th Annual J.P. Morgan Healthcare Conference in January 2026 [5]