News Releases

- Initiated Enrollment in Phase 3 ENSURE Program of Vidofludimus Calcium for the Treatment of Relapsing Multiple Sclerosis; Final Cohort 2 Data from the Phase 2 EMPhASIS Trial Confirms Phase 3 Dose Selection -

Top-Line Data of the CALDOSE-1 Trial Expected to be Available in June of 2022

- Webcast to be Held at 8:00 am ET on February 24, 2022 -

- Unblinded Data Established a Favorable Safety and Tolerability Profile for IMU-935 in Single Dose and 14-Day Multiple Dose Assessments in Healthy Human Subjects -

- Fully Enrolled Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis -

- Webcast to be Held at 8:00 am ET on November 4, 2021 -

- Top-Line Data Expected in the Second Quarter of 2022 -

- Represents the First Time Patients Will Be Treated With the Company's Potentially Best-In-Class RORγt Inverse Agonist -

- Three Abstracts, Including One Late-Breaker, to be Presented on IMU-838, the Company's Selective Oral DHODH Inhibitor, at the 37th Congress of ECTRIMS -

- Preclinical Combination Data Suggests Extra-Ordinary Synergy Between Certain DHODH Inhibitors and Nucleoside Analogues -

- Received FDA Clearance to Initiate Twin IMU-838 Phase 3 ENSURE Trials in Relapsing-Remitting Multiple Sclerosis and Supportive Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis -

- IMU-935 Has Been Observed In Vitro to Inhibit the Generation of Th17 Cells and Production of IL-17 Cytokines Without Impairing RORγt Function Required for Normal Thymocyte Development; May Avoid Risk of Lymphoma Formation Seen in Third-Party RORγt Programs -

- Phase 3 ENSURE Program in Relapsing-Remitting Multiple Sclerosis (RRMS) Comprises Twin Studies Evaluating Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo, Intended to Provide Straightforward Path to Regulatory Approval -

- EMPhASIS Cohort 2 Interim Analysis Confirmed 30 mg Dose of IMU-838 as Most Appropriate for Planned Phase 3 Program in Relapsing-Remitting Multiple Sclerosis, Expected to Begin in the Second Half of 2021 -

- Preplanned Interim Analysis of 12-Week MRI Data from 10 mg IMU-838 Dose and Placebo, in Combination with Existing 30 and 45 mg Dose Data, Establishes Clear Dose-Response Relationship for IMU-838 -

- Phase 3 Program of IMU-838 in Relapsing-Remitting Multiple Sclerosis Expected to Begin in the Second Half of 2021-

- Statistically Significant Decrease in Serum Alkaline Phosphatase (ALP) Levels in the Per-Protocol Population After 24-Week IMU-838 Treatment, as Compared to Baseline -

- Clinical Activity of IMU-838 Confirmed Based on Multiple Secondary Endpoints, Including Clinically Meaningful Improvements in Time to Clinical Recovery and Clinical Improvement -

- Management Provides Update on Timing of Data for IMU-838 in Primary Sclerosing Cholangitis -

- Initial Appointments Include Internationally Recognized Experts: Fred D. Lublin, M.D.; Bruce E. Sands, M.D., M.S.; Jerrold R. Turner, M.D., Ph.D. and Paul J. Utz, M.D. -

- Released Very Positive Phase 2 Data for IMU-838 in Relapsing-Remitting Multiple Sclerosis; Company to Submit End-of-Phase 2 Meeting Requests to Regulatory Authorities at the End of Q1 2021 -

- Top-Line Data Expected in Q1 2021 -

- European Investment Bank and Immunic sign a financing agreement of up to €24.5 million to support the development of Immunic's lead asset, IMU-838, in moderate COVID-19

- Unblinded Subgroup Analyses Show Consistent Effect for MRI Lesion Suppression Across Different Populations -

- Study Meets Primary and Key Secondary Endpoints with High Statistical Significance Indicating Activity for IMU-838 in Relapsing-Remitting Multiple Sclerosis -

- Study Being Conducted in Collaboration with University Hospitals Coventry and Warwickshire NHS Trust -

- Presentation Will Include Preclinical Data of IMU-838 Against SARS-CoV-2 as Well as First Pharmacokinetic Data From the Ongoing Phase 1 Clinical Trial of IMU-935 -

- In Cellular Assays with SARS-CoV-2 Clinical Isolates, IMU-838 Shows Ability to Inhibit Viral Replication of SARS-CoV-2 -

- Top-Line Data from Phase 2 EMPhASIS Trial in Relapsing-Remitting Multiple Sclerosis Expected in Third Quarter 2020 -

Phase 1 Clinical Studies to begin in First Half of 2020

IMU-856 has the potential to address one of the putative root causes of inflammatory bowel disease without impairing the immune system

- Milestone Achieved Nine Months Ahead of Initial Schedule; Top-Line Data Expected in Q3 2020 -

Preclinical Findings Confirm Favorable Profile of IMU-838 as Compared to Teriflunomide in the Potential Treatment of Relapsing-Remitting Multiple Sclerosis

- Unblinded Data Review Committee Recommended Continuation of the Lowest, 10 mg Dose as well as the Highest, 45 mg Dose -

- Study Being Conducted in Collaboration with Investigators at Arizona State University and the Mayo Clinic -

- Phase 2 Trial in Relapsing-Remitting Multiple Sclerosis Expected to be the First Efficacy Read-Out of IMU‑838; Top-line Data Anticipated in Q3 2020 -

- Results confirm IMU-935 as a potent inverse agonist of RORϒt with an IC₅₀ of 24 nM, leading to potent inhibition of Th17 differentiation while allowing normal thymocyte maturation -