Immunic, Inc. · NASDAQ:IMUX
Immunic — 8th Joint ACTRIMS-ECTRIMS Meeting 2020
10 slides from Immunic's conference presentation, Sep 11, 2020
Slide 1: Top-line Results of EMPhASIS, a Phase 2 Clinical Trial of Vidofludimus Calcium in RRMS
Top-line Results of EMPhASIS, a Phase 2 Clinical Trial of Vidofludimus Calcium (IMU-838) in Relapsing- Remitting Multiple Sclerosis Robert J Fox!, Heinz WiendI2, Nicola de Stefano?, Johann Sellner’, Andreas Muehler® for the EMPhASIS study team 2 Mellen Center for Multiple Sclerosis, Cleveland Clinic
Slide 2: Disclosures
Disclosures RJF has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Biogen, Celgene, EMD Serono, Genentech, Immunic, Novartis, and Teva. Dr. Fox has received research support from, or the institution he works for, ha
Slide 3: EMPhASIS: Phase 2 Study Overview
EMPhASIS: Phase 2 Study Overview IMU-838 (Vidofludimus Calcium) Included Population: RRMS With Relevant Disease Activity Next-generation, small-molecular DHODH inhibitor for RRMS1: © Optimized for human DHODH inhibition ~ Lack of off-target effect on kinases » Safety profile available from exposure
Slide 4: EMPhASIS Flow Chart and Key Study Endpoints
EMPhASIS Flow Chart and Key Study Endpoints Unblinded 30 mg IMU-838 — ; 30 mg IMU-838 — 30 or 45 mg IMU-838° — a 45 mg IMU-838_ — EoMT ———— 45 mg IMU-838 — 30 or 45 mg IMU-838° — Scr. exam. BL MRI Placebo 30 mg IMU-838 — 30 or 45 mg IMU-838° — _ EoT 45 mg IMU-838 — 30 or 45 mg IMU-838° — EoT | | w24
Slide 5: Patient Assignments and Treatment Discontinuations
Patient Assignments and Treatment Discontinuations ZEN x Randomized barlents Treatment Discontinuation Before Week 24 (all dosed patients until end of blinded treatment) N=210 Se Placebo 7.2% 5/69 All IMU-838 43% 6/140 | Not Dosed Net 30 mg IMU-838 li 2/71 45 mg IMU-838 4/69 ntinuations Va Placebo 4
Slide 6: Study Met Primary and Key Secondary Endpoints
Study Met Primary and Key Secondary Endpoints Reduction rz of CUAMRI p-value IC oe alecebo Lesions (1-sided) vs. Placebo Primary 45 mg IMU-838 bgroup Analysis 30mg IMI Forest Plot endef 4 ee at ai. 0 unde ein aa. Y N=69 62% 0.0002 se relia vs. Placebo ° sey K N=69 Age> yeas ey 30 mg IMU-838 night Se
Slide 7: Secondary Endpoints
fe ' } i $ Secondary Endpoints Cumulative Number of Gd+ lesion * Effect on Annualized Relapse Rate (ARR) Treatment Group Adjusted Mean ARR 30 mg IMU-838 45 mg IMU-838 Placebo Median percentage change from Baseline to Week 24 in serum neurofilament (including 95% confidence interve 30mg IMU-838 45 mg
Slide 8: Overall Adverse Event Rates
Overall Adverse Event Rates Number of P There were 3 patients with serious adverse events (SAE) inthis trial: Placebo: Squamous cell carcinoma of the cervix 30 mg: open fracture, ureterolithiasis/hydronephrosis 45 mg: no treatment-emergent SAE reported There were no on-study deaths in this trial. EA
Slide 9: Renal, Hepatic, Hematology Safety
Renal, Hepatic, Hematology Safety Liver Enzyme Elevation Events 30 mgIMU-838 | 45 mgIMU-838 Number of Patients Evaluated aL 69 ALT or AST >5xULN ALT or AST >10xULN ALT or AST >15xULN 30 mg IMU-838 45 mg IMU-838, 150 Neutophis abs, 1091 No Generalized Effect on Neutrophils Court wit ee 45mg IMU-898 “
Slide 10: Conclusions
Conclusions Efficacy Safety Primary and key secondary endpoints met Consistent with prior studies in other patient with high statistical significance populations, IMU-838 was well-tolerated All other secondary endpoints were — Safety profile is comparable to the placebo consistently favorable to IMU