Immunic, Inc. · NASDAQ:IMUX
Immunic — FY2023 Earnings Presentation
19 slides from Immunic's earnings presentation, Feb 22, 2024
Slide 1: Fourth Quarter and Year End 2023 Financial Results and Corporate Update
Immunic Therapeutics Fourth Quarter and Year End 2023 Financial Results and Corporate Update NASDAQ: IMUX | February 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 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 Fourth Quarter and Year End 2023 Financial Results and Corporate Update 01 Fourth 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. | Feb/22/2024
Slide 4: Fourth Quarter 2023 and Subsequent Highlights
01 Fourth Quarter 2023 and Subsequent Highlights
Slide 5: January 2024: Three-Tranche Private Placement of up to $240M
January 2024: Three-Tranche Private Placement of up to $240M, Cash Runway Extended Into Q3/2025 Based on Initial $80M Tranche § First tranche was an upfront payment of $80 million at $1.43 per share § Second tranche is a conditional mandatory purchase of an additional $80 million at $1.716 per share
Slide 6: October: Positive Interim Data from Phase 2 CALLIPER Trial in Progressive MS
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 Mean Change to Week 24 as Compared to Placebo in % of Bas
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: 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: Expanded Vidofludimus Calcium Patent Portfolio with Two New US Patents
November: Expanded Vidofludimus Calcium Patent Portfolio with Two New Patents Granted in the US, Protection Currently Expected Into 2041 in the US Notice of Allowance from the USPTO for patent application 17/992,162, covering the dosing regimens associated with vidofludimus calcium and other salt as
Slide 10: 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 11: November: 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 12: Financial and Operating Results
02 Financial and Operating Results
Slide 13: Consolidated Statements of Operations
Consolidated Statements of Operations (In thousands, except share and per share amounts, unaudited) Years Ended December 31, 2023 2022 Operating expenses: Research and development $ 83,215 $ 71,255 General and administrative 16,008 15,263 Goodwill impairment — 32,970 Total operating expenses 99,223
Slide 14: Anticipated Clinical Milestones
03 Anticipated Clinical Milestones
Slide 15: Several Clinical Value Inflection Points Ahead
Several Clinical Value Inflection Points Ahead IMU-838 § Readout phase 2 CALLIPER trial in PMS estimated for April 2025 § Interim futility analysis phase 3 ENSURE IMU-838 program estimated for late 2024 in RMS § Readout first phase 3 ENSURE trial estimated for Q2/2026 § Phase 2 clinical trial in pre
Slide 16: Q&A Session
04 Q&A Session
Slide 17: Summary and Highlights
05 Summary and Highlights
Slide 18: Advanced Clinical Pipeline
Advanced Clinical Pipeline Well Differentiated Programs in Various Phases of Clinical Development Program Preclinical Phase 1 Phase 2 Phase 3 Relapsing Multiple Sclerosis (RMS) – ENSURE Trials Vidofludimus Calcium Progressive Multiple Sclerosis (PMS) – CALLIPER Trial (IMU-838) Ulcerative Colitis (UC
Slide 19: 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: +49-89-2080477-09 Australia Email: [email protected]