News Releases

- 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 -

- Developing Oral Therapies with Best-in-Class Potential -

Of the Votes Received to Date, More than 98% are Voting in Favor of the Business Combination

Transaction Expected to Create NASDAQ-listed Biopharmaceutical Company Focused on Advancing Immunic‘s Compelling Pipeline of Clinical-Stage and Late Preclinical Assets

Immunic AG gains exclusive, worldwide rights to promising drug development program with novel target for treatment of inflammatory bowel disease

First patient with ulcerative colitis entered the ‘CALDOSE-1’ trial with Immunic’s oral investigational drug IMU-838, a best-in-class DHODH inhibitor

FDA has granted IND approval for Immunic’s oral investigational drug IMU-838

Two phase 1 studies for IMU-838 in healthy volunteers have been completed

Omega and Fund+ broaden Immunic’s investor base and add an additional EUR 10 million (USD 12 million) in equity financing

Series A financing round extended to EUR 21.7 Million