IMMUNIC, INC.

Immunic, Inc. is a late-stage biotechnology company focused on developing new oral treatments for neurological and gastrointestinal diseases. The company is headquartered in New York City, with its primary operations located in Gräfelfing near Munich, Germany. As of February 1, 2026, Immunic had 92 employees. Immunic is advancing several orally administered, small molecule programs designed to address the needs of patients with serious chronic inflammatory and autoimmune diseases. These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with relapsing multiple sclerosis (RMS). This program has demonstrated therapeutic activity in Phase 2 clinical trials for patients with relapsing-remitting multiple sclerosis (RRMS), progressive multiple sclerosis (PMS), and other conditions. The IMU-856 program aims to regenerate bowel epithelium and restore intestinal barrier function, potentially applicable to various gastrointestinal diseases such as celiac disease, inflammatory bowel disease (IBD), and Graft-versus-Host-Disease (GvHD). Additionally, the IMU-381 program involves next-generation molecules in preclinical testing for neurologic, gastrointestinal, and other autoimmune diseases, utilizing the company's nuclear receptor-related 1 (Nurr1) platform. Immunic's most advanced drug candidate, vidofludimus calcium (IMU-838), is currently being evaluated in ongoing multiple sclerosis (MS) trials to support potential regulatory approvals for MS patients in major markets. The Phase 3 ENSURE program for vidofludimus calcium in RMS consists of two studies assessing its efficacy, safety, and tolerability against a placebo. In October 2024, an interim analysis of the ENSURE program confirmed that predetermined futility criteria were not met, and an unblinded Independent Data Monitoring Committee (IDMC) recommended continuing both ENSURE trials without changes, including no increase in sample size. Enrollment for both ENSURE trials was completed in June 2025.