Slide 1: Positive Outcome of Interim Analysis of Phase 3 ENSURE Program
Immunic Therapeutics Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis NASDAQ: IMUX | October 22, 2024
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the saf e harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securitie
Slide 3: Vidofludimus Calcium: Clinical Trials Overview in Multiple Sclerosis (MS)
Vidofludimus Calcium: Clinical Trials Overview in Multiple Sclerosis (MS) H2/2026 ENSURE-2 RELAPSING MS Phase 3 Actively recruiting, n=1050 patients planned Completion (expected) Q2/2026 ENSURE-1 RELAPSING MS Phase 3 Actively recruiting, n=1050 patients planned Completion (expected) April 2025 CALLI
Slide 4: Vidofludimus Calcium Has the Potential to Transform the Oral MS DMT Market
Vidofludimus Calcium Has the Potential to Transform the Oral Multiple Sclerosis DMT Market Anticipated Profile First-in-class, dual mode of action approach designed to address the full spectrum of disease: ▪ Nurr1 activation provides direct neuroprotective effects ▪ DHODH inhibition is associated wi
Slide 5: Positive Outcome of Interim Analysis of Phase 3 ENSURE Program
Vidofludimus Calcium in Relapsing Multiple Sclerosis Positive Outcome of Interim Analysis of Phase 3 ENSURE Program
Slide 6: ENSURE: Ongoing Pivotal Phase 3 Trials in Relapsing MS
ENSURE: Ongoing Pivotal Phase 3 Trials in Relapsing MS NCT05134441 & NCT05201638 Two Multicenter, Randomized, Double-Blind Phase 3 Trials ▪ Approximately 1,050 patients in each trial Coordinating Investigator ▪ More than 100 sites in the United States, Latin America, Central and Eastern Europe, and
Slide 7: ENSURE: General Phase 3 Study Design in RMS
ENSURE: General Phase 3 Study Design in RMS Main Treatment Period Open-Label Extension Period (Optional) Screening Period 72 Weeks (Blinded) Up to 8 Years (Unblinded) 30 mg IMU-838 EoMT R 30 mg IMU-838 EoT EoS Placebo EoMT Screening exam Visits every 12 weeks Visits every 24/48 weeks D0 W24 W48 W72
Slide 8: ENSURE: Key Study Assumptions and Interim Analysis Procedures
ENSURE: Key Study Assumptions and Interim Analysis Procedures Key Study Assumptions Interim Analysis Procedures ▪ Primary endpoint: comparison of time to first relapse ▪ Conditional power (CP) estimates the power of the study between the 30 mg vidofludimus calcium and placebo given the results obser
Slide 9: ENSURE: Positive Outcome of Interim Analysis
ENSURE: Positive Outcome of Interim Analysis Assumptions Results ▪ Based on a pre-specified assessment after ▪ Two decisions made by the unblinded IDMC: approximately half of the planned first relapse – First question, whether the trials are futile, events occurred in the double-blind treatment answ
Slide 10: Quote from Andreas Muehler, Chief Medical Officer
Andreas Muehler, M.D., M.B.A. Chief Medical Officer of Immunic “The IDMC’s favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line wit
Slide 11: Q&A Session
Interim Futility Analysis of the Phase 3 ENSURE Program Q&A Session
Slide 12: Summary
Interim Futility Analysis of the Phase 3 ENSURE Program Summary
Slide 13: Quote from Daniel Vitt, Chief Executive Officer
Daniel Vitt, Ph.D. Chief Executive Officer of Immunic “I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the program. We are confident in vidofludimus calcium’s potential to transf
Slide 14: Vidofludimus Calcium in Multiple Sclerosis
Vidofludimus Calcium in Multiple Sclerosis Consistent and Differentiated Results to Date Support Straightforward Path Towards Potential Regulatory Approvals EMPhASIS: CALLIPER: CALLIPER: RMS NDA Positive phase 2 RRMS data demonstrating Positive phase 2 PMS PMS top-line data Submission statistically
Slide 15: Vidofludimus Calcium Aims to Redefine the Oral Multiple Sclerosis Treatment Landscape
Vidofludimus Calcium Aims to Redefine the Oral Multiple Sclerosis Treatment Landscape Designed to combine the best of two worlds: neuroprotection and relapse prevention ▪ Positive phase 2 data in relapsing-remitting MS ▪ Hints to slowing down disability worsening ▪ Positive outcome of interim futili
Slide 16: Thank You!
Thank You! Immunic, Inc. Immunic AG 1200 Avenue of the Americas Lochhamer Schlag 21 New York City, NY 10036 82166 Gräfelfing (Munich) USA Germany Jessica Breu Vice President Investor Relations & Communications Immunic Australia Pty. Ltd. Melbourne Phone: +1-332-255-9819 Australia Email: ir@imux.com