Immunic, Inc. · NASDAQ:IMUX
Immunic — Investor Presentation (April 2025)
44 slides from Immunic's investor presentation, Apr 30, 2025
Slide 1: Positive Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive MS
Immunic Therapeutics Positive Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis NASDAQ: IMUX | April 30, 2025
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: Today's Speakers
Positive Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Today’s Speakers Daniel Vitt, PhD Jason Tardio Chief Executive Officer President & Chief Operating Officer Andreas Muehler, MD, MBA Jessica Breu Chief Medical Officer Vice President Investor Relations
Slide 4: 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) CALLIPER PROGRES
Slide 5: Phase 2 CALLIPER Trial: Vidofludimus Calcium in Progressive Multiple Sclerosis
Phase 2 CALLIPER Trial Vidofludimus Calcium in Progressive Multiple Sclerosis
Slide 6: Vidofludimus Calcium Has the Potential to be the First and Only Oral DMT for Relapsing and Progressive MS
Vidofludimus Calcium Has the Potential to be the First and Only Oral DMT Approved for Both Relapsing and Progressive MS Relapsing MS (RMS) Progressive MS (PMS) Non-Active SPMS DHODH Inhibition Nurr1 Activation Relapses and focal inflammation Smoldering disease and neurodegeneration DMT: disease-modi
Slide 7: Regardless of Subtype, the Outcome of Every MS Patient Journey Is Disability
Regardless of the Subtype, the Outcome of Every Patient Journey in Multiple Sclerosis Is Physical and/or Cognitive Disability 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 10 1.0 3.0 5.0 6.0 7.5 9.0 No disability, minimal Moderate disability in one Disability severe enough
Slide 8: Why Did Immunic Conduct the Exploratory CALLIPER Trial in Progressive MS?
Why Did Immunic Conduct the Exploratory CALLIPER Trial in Patients With Progressive Multiple Sclerosis? Objectives of the Exploratory Phase 2 CALLIPER Trial Scientific: Does vidofludimus calcium show signs of direct neuroprotection in multiple sclerosis via its mechanism of Nurr1 activation? Clinica
Slide 9: CALLIPER: Phase 2 Clinical Trial in Progressive Multiple Sclerosis
CALLIPER: Phase 2 Clinical Trial in Progressive Multiple Sclerosis NCT05054140 Multicenter, Randomized, Double- Extension Blind, Placebo-Controlled Phase 2 Trial Screening Period Main Treatment Period (Blinded) (Open-Label) ▪ 467 adult patients, aged 18 to 65 years, enrolled at more than 70 sites in
Slide 10: Baseline and Patient Characteristics
Top-Line Data Phase 2 CALLIPER Trial Baseline and Patient Characteristics
Slide 11: CALLIPER: Patient Demographics and Baseline Characteristics
CALLIPER: Patient Demographics and Baseline Characteristics Total Study Population of 467 Enrolled Patients Progressive Disease Subtypes Baseline Characteristics Baseline Patient Characteristics Total (N=467) N=47 Age [years], median (min-max) 51.0 (21-65) 10.1% N=152 Gender (n and % female) 302 (64
Slide 12: Clinical Endpoints
Top-Line Data Phase 2 CALLIPER Trial Clinical Endpoints
Slide 13: Vidofludimus Calcium Showed Substantial Reduction of 24wCDW-EDSS Events
Vidofludimus Calcium Showed Substantial Reduction of 24wCDW-EDSS Events
Slide 14: Vidofludimus Calcium Reduced Relative Risk of 24wCDW in Overall Population and Subtypes
Vidofludimus Calcium Reduced Relative Risk of 24wCDW in Overall Study Population and Subtypes Compared to Placebo Proportion of Patients Overall CALLIPER Patient PPMS naSPMS With 24wCDW Events Population (N=467) (N=152) (N=268) Vidofludimus Calcium 16.2% 19.5% 14.1% Placebo 20.3% 28.0% 16.5% Relativ
Slide 15: Comparison CALLIPER Versus ORATORIO Trials in PPMS Population
Comparison CALLIPER Versus ORATORIO Trials in PPMS Population ORATORIO* CALLIPER (N=732) (N=152) Mean Age (Years) 44.6 47.4 Female (N,%) 361 (49.3%) 93 (61.1%) EDSS - Mean 4.7 4.9 EDSS - Median 4.5 4.5 Gd+ Lesions at Baseline MRI (N,%) 26.6% 17.8% Relative Risk Reduction of 24wCDW, Active 25% 30% Ov
Slide 16: Vidofludimus Calcium Reduced Relative Risk of 24wCDW Events in Patients Without Gd+ Lesions
Vidofludimus Calcium Reduced Relative Risk of 24wCDW Events in Patients Without Gd+ Lesions at Baseline Proportion and number of patients without Gd+ lesions at baseline Reduction of 24wCDW Events by 29% with 24wCDW EDSS in vidofludimus calcium group (N=197) compared to placebo (N=194) in Patients W
Slide 17: CALLIPER Demonstrated Neuroprotective Potential of Vidofludimus Calcium in PMS Patients
CALLIPER successfully demonstrated the neuroprotective potential of vidofludimus calcium in PMS patients Clinically meaningful risk reduction of confirmed disability worsening of 20% in overall PMS population and even more prominent 30% reduction in PPMS population
Slide 18: Magnetic Resonance Imaging (MRI) Endpoints
Top-Line Data Phase 2 CALLIPER Trial Magnetic Resonance Imaging (MRI) Endpoints
Slide 19: Brain Atrophy Endpoints Consistently Demonstrated Beneficial Effect of Vidofludimus Calcium
Brain Atrophy Endpoints Consistently Demonstrated Beneficial Effect of Vidofludimus Calcium Compared to Placebo Change in Whole Brain Volume - All Patients 0 Re-Baselined at 6 Months ▪ Modest benefit on exploratory primary MRI endpoint: Change in LS Mean from Baseline -0.2 decreased annualized rate
Slide 20: Vidofludimus Calcium Substantially Lowered Volume of New/Enlarging T2 Lesions
Vidofludimus Calcium Substantially Lowered Volume of New/Enlarging T2 Lesions Compared to Placebo ▪ Change of T2 lesion volume (cm³) gets steadily worse compared to baseline in placebo 2.97% patients while remaining stable in vidofludimus calcium patients ▪ Volume change different between arms at ev
Slide 21: Safety and Tolerability
Top-Line Data Phase 2 CALLIPER Trial Safety and Tolerability
Slide 22: Top-Line Data Confirmed Favorable Safety and Tolerability Profile
Top-Line Data Confirmed Favorable Safety and Tolerability Profile of Vidofludimus Calcium Observed in Previous Clinical Trials Number of Patients With Any TEAE and SAE Vidofludimus Placebo Calcium N=235 N=233 ▪ No new safety signals identified Any TEAE, n(%) 163 (69.4) 159 (68.5) ▪ Occurrence of TEA
Slide 23: Commercial Background
Top-Line Data Phase 2 CALLIPER Trial Commercial Background
Slide 24: Huge Unmet Medical Need Exists in PPMS
Huge Unmet Medical Need Exists in PPMS, An Underdiagnosed and Tougher to Treat Patient Population ▪ PPMS, which affects 10-15% of people diagnosed with MS, is characterized by a steady worsening of neurological function from the beginning of the disease, without distinct relapses or periods of remis
Slide 25: Neurologists Still Identify New DMTs for PPMS as High Unmet Need
Even With an Approved Therapy, Neurologists Still Identify New DMTs to Treat PPMS as an Area of High Unmet Need in MS High Level of Unmet Needs for New DMTs % of respondents selecting high (8-10 on a 10-point scale) “We need a safe and New products to treat PIRA effective oral treatment for PPMS.” N
Slide 26: Currently Approved Therapy Does Not Address PPMS Patient Needs
Currently Approved Therapy Does Not Address PPMS Patient Needs Non-immunosuppressant mode of action: ▪ B-cell depletion significantly reduces the body's immune response, making patients more susceptible to various infections, including opportunistic ones. This is a major concern, particularly in PPM
Slide 27: Global Market for PPMS Treatment Estimated to Be $6+ Billion
Global Market for PPMS Treatment Estimated to Be $6+ Billion But Less Than Half of All Diagnosed Patients Are Treated Today ~120K 45% ~$2.7B diagnosed PPMS patients of diagnosed PPMS patients in PPMS sales for the only in the US & EU5 are currently on a DMT approved product Total global market for P
Slide 28: Vidofludimus Calcium: Derisked Near-Term Opportunity With $3-7 Billion Peak Potential
Vidofludimus Calcium: Derisked Near-Term Opportunity With $3-7 Billion Peak Potential RMS naSPMS PPMS Indication Phase 3 Phase 3-ready Phase 3-ready Status 76% reduction in 15% relative risk reduction in 30% relative risk reduction in Clinical new Gd+ lesions (Phase 2) 24-week CDW (Phase 2) 24-week
Slide 29: 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 Designed to Combine the Best of Two Worlds: Neuroprotection and Relapse Prevention First-in-class, dual mode of action approach designed to address the full spectrum of disease: ▪ Nurr1 activation provides dir
Slide 30: Conclusions and Outlook
Top-Line Data Phase 2 CALLIPER Trial Conclusions and Outlook
Slide 31: CEO quote on CALLIPER results
“We are delighted about the phase 2 CALLIPER results showing that vidofludimus calcium outperformed historic trials in PPMS regarding numerical reduction of disability progression events.”
Slide 32: CALLIPER Data Paves Way for Potential Registrational Study in PPMS
CALLIPER Data Paves Way for Potential Registrational Study in PPMS Data Impressively Confirms Main Objectives of this Exploratory Phase 2 Clinical Trial Achieved unprecedented proof of concept, in particular, regarding the key medical and future phase 3 endpoint of confirmed disability progression –
Slide 33: Q&A Session
Top-Line Data Phase 2 CALLIPER Trial Q&A Session
Slide 34: Summary
Top-Line Data Phase 2 CALLIPER Trial Summary
Slide 35: Positive Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive MS
Positive Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Reduced relative risk of 24wCDW by 20% in overall study population; even more prominent 30% reduction in high unmet need population of PPMS Remarkable 29% reduction of disability worsening in patients
Slide 36: 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) CALLIPER PROGRES
Slide 37: 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
Slide 38: Back-up
Top-Line Data Phase 2 CALLIPER Trial Back-up
Slide 39: Large Proportion of Patients With Non-Active Disease as Compared to Historical Studies
Large Proportion of Patients With Non-Active Disease as Compared to Historical Studies CALLIPER ORATORIO CALLIPER EXPAND HERCULES PPMS PPMS*** naSPMS a/naSPMS** nrSPMS* Gd+ at 17.8% 22.4% 6.8% 21% 12.6% Screening On-Study 3.3% 7.1% 16% 19% Not reported Relapses (5/152) (19/268) Relapses Within 24 Mo
Slide 40: Comparison of Patient Characteristics for CALLIPER Versus ORATORIO in PPMS
Comparison of Patient Characteristics for CALLIPER Trial Versus ORATORIO Trial in the PPMS Population ORATORIO* CALLIPER Vidofludimus Ocrelizimab Placebo Placebo Calcium (N=488) (N=244) (N=77) (N=75) Mean Age (Years) 44.7 44.4 47.3 45.3 Female (N,%) 237 (48.6%) 124 (50.8%) 51 (66.2%) 42 (56.0%) EDSS
Slide 41: Comparison of Patient Characteristics for CALLIPER Versus Other Studies in Non-Active SPMS
Comparison Patient Characteristics for CALLIPER Trial Versus Other Studies in the Non-Active/Non-Relapsing SPMS Population HERCULES 3* CALLIPER Vidofludimus Tolebrutinib Placebo Placebo Calcium (N=754) (N=377) (N=135) (N=133) Mean Age (Years) 48.9 48.9 51.3 50.9 Female (N,%) 454 (60.2%) 242 (64.2%)
Slide 42: Vidofludimus Calcium Reduced Relative Risk of 24wCDW in Overall Population and Subtypes
Vidofludimus Calcium Reduced Relative Risk of 24wCDW in Overall Study Population and Subtypes Compared to Placebo Proportion of Patients Overall CALLIPER Patient PPMS naSPMS With 24wCDW Events Population 16.2% 19.5% 14.1% Vidofludimus Calcium (38/235) (15/77) (19/135) 20.3% 28.0% 16.5% Placebo (47/2
Slide 43: Relative Risk Reduction of 24wCDW Events in Various Non-Active Patient Subpopulations
Relative Risk Reduction of 24wCDW Events Shows Similar Performance in Various Non-Active Patient Subpopulations Proportion of Patients Overall CALLIPER Non-Active No Gd+ Lesions at Non-Relapsing With 24wCDW Events Patient Population Disease Baseline Population 16.2% 12.1% 14.2% 14.4% Vidofludimus Ca
Slide 44: Vidofludimus Calcium Reduces Gadolinium-Enhancing Lesions During Study Period
Vidofludimus Calcium Reduces Gadolinium-Enhancing Lesions During Study Period Number of Patients with Overall CALLIPER Study PPMS a/naSPMS Gd+ Lesions Population Vidofludimus Calcium 6.4% 5.2% 7.0% Placebo 10.8% 12.0% 10.2% Relative Risk Ratio 0.59 0.43 0.69 Relative Risk Reduction 41% 57% 31% ITT =