Immunic, Inc. · NASDAQ:IMUX
Immunic — Q3 2023 Earnings Presentation
20 slides from Immunic's earnings presentation, Nov 14, 2023
Slide 1: Third Quarter 2023 Financial Results and Corporate Update
Immunic Therapeutics Third Quarter 2023 Financial Results and Corporate Update NASDAQ: IMUX | November 14, 2023
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 safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Slide 3: Agenda
Agenda Third Quarter 2023 Financial Results and Corporate Update 01 Third Quarter 2023 and Subsequent Highlights 04 Q&A Session 02 Financial and Operating Results 05 Summary and Highlights 03 Anticipated Clinical Milestones 3 | © Immunic, Inc. | Nov/14/2023
Slide 4: Third Quarter 2023 and Subsequent Highlights
01 Third Quarter 2023 and Subsequent Highlights
Slide 5: August: Enrolled Last Patient in Phase 2 CALLIPER Trial in Progressive MS
August: Enrolled Last, 467th Patient in Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial* Main Treatment Period (Blinded) Screening Period § Coordinating Investigator: Robert J. Fox, M.D., Clevela
Slide 6: October: Reported Positive Interim Data from Phase 2 CALLIPER Trial
October: Reported Positive Interim Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Improvements in Serum NfL for Vidofludimus Calcium Consistent Throughout the Overall PMS Population and All Subtypes Change to Week 24 as Compared to Placebo in % of Baseline
Slide 7: NfL Reduction Compares Favorably with Other MS Therapies
NfL Reduction Compares Favorably with Other MS Therapies CALLIPER Interim Data Compared to Select Historical Trials Vidofludimus Ocrelizumab Vidofludimus Siponimod Vidofludimus Siponimod Vidofludimus Ocrelizumab Evobrutinib PPMS PPMS n-aSPMS n-aSPMS aSPMS aSPMS RRMS RMS RRMS (CALLIPER) (ORATORIO) (C
Slide 8: October: Presented Phase 2 EMPhASIS Trial Data in Relapsing-Remitting MS
October: Presented Phase 2 EMPhASIS Trial Data of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023 Reduction in Neurofilament Light Chain by Vidofludimus Calcium: The EMPHASIS Study The 9th Joint ECTRIMS-ACTRIMS Meeting | 11 – 13 October 2023 | Milan, Italy R. Fox C. Wol
Slide 9: November: Received Notice of Allowance for US Patent Protecting RMS Treatment
November: Received Notice of Allowance for United States Patent Protecting the Treatment of RMS with Vidofludimus and Its Salts Immunic has created a multilayered approach to exclusivity for vidofludimus calcium: Patent on composition-of-matter for salt forms of vidofludimus calcium, granted in the
Slide 10: July: Hosted Virtual Celiac Disease Roundtable
July: Hosted Virtual Celiac Disease Roundtable Ongoing Active Celiac Disease and Its High Unmet Medical Need for New Treatment Options § Featured experts included: - Ciarán P. Kelly, M.D., Harvard Medical School, Boston, MA - Joseph A. Murray, M.D., Mayo Clinic, Rochester, MN - Marilyn G. Geller, Ce
Slide 11: October: Presented Two Abstracts at UEG Week 2023
October: Presented Two Abstracts at the UEG (United European Gastroenterology) Week 2023 (October 14-17 in Copenhagen, Denmark) Positive Phase 1b Data of IMU-856 Positive Phase 2 Maintenance Phase in Celiac Disease Data of Vidofludimus Calcium in UC § Moderated Poster: Franziska Burianek, M.D., § Or
Slide 12: November: Presented Phase 1b Data of IMU-856 in Celiac Disease at AOECS
November: Presented Phase 1b Data of IMU-856 in Celiac Disease at the AOECS 35th General Assembly Conference 2023 § Association of European Coeliac Societies (AOECS) 35th General Assembly Conference 2023 § November 2-5 in Athens, Greece § Virtual e-poster: Franziska Burianek, M.D., Senior Medical Di
Slide 13: Financial and Operating Results
02 Financial and Operating Results
Slide 14: Condensed Consolidated Statements of Operations
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts, unaudited) Three Months Nine Months Ended September 30, Ended September 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 19,796 $ 16,537 $ 63,931 $ 50,520 General and administrati
Slide 15: Anticipated Clinical Milestones
03 Anticipated Clinical Milestones
Slide 16: Several Clinical Value Inflection Points Ahead
Several Clinical Value Inflection Points Ahead IMU-838 § Readout phase 2 CALLIPER trial in PMS estimated for April of 2025 § Interim futility analysis phase 3 ENSURE IMU-838 program estimated for late 2024 in RMS § Readout of first phase 3 ENSURE trial estimated for end of 2025 § Phase 2 clinical tr
Slide 17: Q&A Session
04 Q&A Session
Slide 18: Summary and Highlights
05 Summary and Highlights
Slide 19: Advanced Clinical Pipeline
Advanced Clinical Pipeline Well Differentiated Programs in Various Phases of Clinical Development Program Preclinical Phase 1 Phase 2 Phase 3 Key Milestones § Interim futility analysis of ENSURE Relapsing Multiple Sclerosis (RMS) – ENSURE Trials program in RMS planned after approximately half of the
Slide 20: 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 Head of IR & Communications Immunic Australia Pty. Ltd. Phone: +49-89-2080477-09 Melbourne Email: ir@imux.com Australia Web: www.imux.com 20