Immunic, Inc. · NASDAQ:IMUX
Immunic — Q1 2023 Earnings Presentation
18 slides from Immunic's earnings presentation, May 11, 2023
Slide 1: Immunic Therapeutics
Immunic Therapeutics First Quarter 2023 Financial Results and Corporate Update NASDAQ: IMUX | May 11, 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 First Quarter 2023 Financial Results and Corporate Update 01 First 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. | May/11/2023
Slide 4: First Quarter 2023 and Subsequent Highlights
01 First Quarter 2023 and Subsequent Highlights
Slide 5: February: Hosted Virtual Celiac Disease R&D Webcast
February: Hosted Virtual Celiac Disease R&D Webcast Current Pathways for Drug Development & Persistent Disease Activity Despite Gluten-Free Diet as the Unmet Medical Need § Featured key opinion leaders: - Joseph A. Murray, MD, Mayo Clinic, Rochester, MN - Michael Schumann, MD, Charité – Universitäts
Slide 6: February: Presented Data From Phase 2 EMPhASIS Trial at ACTRIMS Forum 2023
February: Presented Data From Phase 2 EMPhASIS Trial at ACTRIMS Forum 2023 Assessment of effect of vidofludimus calcium on confirmed disability worsening in the blinded treatment and open-label extension periods of the phase 2 study (EMPhASIS) in relapsing-remitting multiple sclerosis § Eighth annua
Slide 7: April: Positive Maintenance Phase Data of Phase 2 CALDOSE-1 Trial
April: Positive Maintenance Phase Data of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Moderate-to-Severe Ulcerative Colitis 30 mg of vidofludimus calcium found to be statistically superior to achieve clinical remission during maintenance Clinical Remission at Week 50 treatment at week 50 as c
Slide 8: April: Appointed Richard Rudick, M.D. to Board of Directors
April: Appointed Richard Rudick, M.D. to Board of Directors § Thought-leader in multiple sclerosis with decades of experience in the clinic, academia and industry § Effective April 26, 2023 8 | © Immunic, Inc. | May/11/2023
Slide 9: May: Positive Results From Phase 1b Trial of IMU-856 in Celiac Disease
May: Positive Results From Phase 1b Trial of IMU-856 in Celiac Disease, Positive Effects in Main Four Dimensions of Clinical Outcome IMU-856 effectively reduces IMU-856 reduces/reverses gluten-induced intestinal damage, gluten-induced symptoms as measured by villous height Protect Improve reported b
Slide 10: May: Presented Clinical and Preclinical Data for IMU-856 at Digestive Disease Week 2023
May: Presented Clinical and Preclinical Data for IMU-856 at Digestive Disease Week 2023 § May 6-9 in Chicago § Virtual e-poster: Franziska Buriánek, M.D., Senior Medical Director at Immunic – Data from the single and multiple ascending dose portions of the phase 1 clinical trial of IMU-856 in health
Slide 11: Financial and Operating Results
02 Financial and Operating Results
Slide 12: Condensed Consolidated Statements of Operations
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts, unaudited) Three Months Ended March 31, 2023 2022 Operating expenses: Research and development $ 22,963 $ 17,445 General and administrative 4,288 3,990 Total operating expenses 27,251 21,435 Loss from
Slide 13: Anticipated Clinical Milestones
03 Anticipated Clinical Milestones
Slide 14: Several Clinical Value Inflection Points Expected
Several Clinical Value Inflection Points Expected § Interim analysis phase 2 CALLIPER trial IMU-838 estimated for H2/2023 in PMS § Readout phase 2 CALLIPER trial estimated for end of 2024 § Interim analysis phase 3 ENSURE program IMU-838 estimated for late 2024 in RMS § Readout phase 3 ENSURE-1 tria
Slide 15: Q&A Session
04 Q&A Session
Slide 16: Summary and Highlights
05 Summary and Highlights
Slide 17: 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 Relapsing Multiple Sclerosis (RMS) – ENSURE Trials § Interim analysis of CALLIPER trial in PMS planned after half of the Vidofludimus patients
Slide 18: 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: [email protected] Australia Web: www.imux.com 18