Immunic : Presentation (20250307 Immunic Company+Overview March 2025)

Published: 2025-03-07 08:37:08 ET IMUX

Immunic Therapeutics

Developing Selective Oral Therapies in Immunology

NASDAQ: IMUX | March 2025

CLINICAL-STAGE

BIOPHARMACEUTICAL

COMPANY (NASDAQ: IMUX)

Dedicated to improving the lives of patients with chronic inflammatory and autoimmune diseases

Innovative pipeline:

First-in-class oral drugs with unique modes of actions for multiple sclerosis and gastrointestinal diseases

Experienced leadership team:

Successfully developed and commercialized multiple medicines

Near-term catalysts:

Series of milestones targeting blockbuster market opportunities

Large commercial opportunity:

$2-6 billion peak sales potential for phase 3 program in multiple sclerosis

Financials:

Cash balance of USD 59.1 million as of Sep 30, 2024

Leadership Team

Company is Led by an Experienced Management Team

Daniel Vitt,

Jason Tardio,

Andreas Muehler,

PhD

MBA

MD, MBA

Chief Executive

President & Chief

Chief Medical

Officer

Operating Officer

Officer

Hella Kohlhof, PhD

Glenn Whaley, CPA

Patrick Walsh

Chief Scientific

Chief Financial

Chief Business

Officer

Inderpal Singh

Werner Gladdines

Duane Nash,

General Counsel

Chief Development

MD, JD, MBA

Officer

Executive

Chairman

4 | © Immunic, Inc. | Mar/07/2025

Advanced Clinical Pipeline

Well Differentiated Programs in Various Phases of Clinical Development

Program

Preclinical

Phase 1

Phase 2

Phase 3

Key Program Updates

✓ Phase 2 EMPhASIS trial in relapsing-remitting MS

successfully completed

Relapsing Multiple Sclerosis (RMS) - ENSURE-1 and ENSURE-2 Trials

✓ Interim analysis of ENSURE program completed, IDMC

recommendation to continue trials as planned

Vidofludimus

✓ Interim biomarker readout of CALLIPER trial completed

Calcium

Progressive Multiple Sclerosis (PMS) - CALLIPER Trial

with strong NfL reduction effects

(IMU-838)*

✓ Phase 2 CALDOSE-1 trial in UC completed, effective in

50 weeks maintenance phase

▪ Top-line data from CALLIPER trial expected in April 2025

Ulcerative Colitis (UC) - CALDOSE-1 Trial

▪ Completion of first ENSURE trial expected in Q2/2026,

second in H2/2026

✓ Phase 1/1b trial in healthy volunteers and celiac disease

completed, first proof-of-concept in celiac disease

Celiac Disease and other Gastrointestinal Disorders

IMU-856

✓ Dose-dependent increase of endogenous GLP-1 in post

hoc analysis of phase 1b trial in celiac disease

▪ Further clinical testing in preparation

IMU-381

Gastrointestinal Diseases

Ongoing

Completed

In preparation or planned

*Additional investigator-sponsored phase 2 RAPID_REVIVE trial of vidofludimus calcium in post COVID syndrome ongoing, sponsoredby University Hospital Frankfurt

5 | © Immunic, Inc. | Mar/07/2025

Vidofludimus Calcium in Multiple Sclerosis (MS)

Targeted to Elevate the Standard of Care for the Full Spectrum of Multiple Sclerosis Patients

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:

Oral DMT category: Achieves best-in-classbenefit / risk profile by combining strong efficacy with safety, tolerability, and once-daily convenience

No first-dose or on-treatment monitoring makes it an easy start or switch to therapy

No anticipated black box warnings or serious infection risk (e.g., PML, malignancies, etc.)

If approved, peak sales potential for vidofludimus calcium of $2-6 billion[1]

DMT: disease-modifying therapy; Nurr1: nuclear receptor-related 1; DHODH: dihydroorotate dehydrogenase; PML: progressive multifocal leukoencephalopathy [1] Based on Immunic internal market research

7 | © Immunic, Inc. | Mar/07/2025

Multiple Sclerosis is a Lifelong Neurodegenerative Disease

Lifelong Disease

Therapeutic Goal:

Requiring Decades of Therapy

Increase Independence

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

1.0

3.0

5.0

6.0

7.5

9.0

No disability, minimal

Moderate disability in one

Disability severe enough

Requires a walking aid, cane,

Unable to take more

Confined to bed, can

signs of MS

system, or mild disability in up

to impair full daily

crutch, etc. - to walk 100m

than a few steps.

still communicate and

to four systems. No impairment

activities, able to walk

Restricted to wheelchair

eat

to walking

without aid for 200m

Death by MS

Underlying "Invisible Disability Accumulation" Contributes to Disability Progression Over Time Requiring a Dual Mode of Action Approach

Disability

PIRA

Nurr1

activation

(progression independent

of relapse activity)

RAW

DHODH

(relapse-associated worsening)

inhibition

Time

Relapses & MRI lesions / focal

inflammation (RAW)

Smoldering disease and

neurodegeneration (PIRA)

Graphic adapted from Kretzschmar A., Symposium MSVirtual2020 / 8th Joint ACTRIMS-ECTRIMS Meeting and REVIEW article, Front. Immunol., 29 November 2023, Sec. Multiple Sclerosis and Neuroimmunology, Volume 14 - 2023 [1] Scalfari A. Mult Scler. 2021 Jun;27(7):1002-1004 / MRI: magnetic resonance imaging; Nurr1: nuclear receptor-related 1; DHODH: dihydroorotate dehydrogenase; DMT: disease modifying therapy; MS: multiple sclerosis

These observations challenge the dichotomy between relapsing and progressive disease, supporting a one stage disorder model of MS, where all patients exhibit a

progressive course from the disease onset, which can be overlapped by relapses.[1]

The ideal DMT agent will have a significant impact on relapses and focal MRI activity to reduce RAW but also halts the putative processes responsible for smoldering MS/PIRA.

There Are Three Distinct MS Indications

The Different Indications Have Different Paths and Drivers of the Disability Progression

Relapsing MS

Worsening

Relapse

RRMS

aSPMS

Disability

Time

Non-Active SPMS

WorseningDisability

RMS

Phase

Time

Primary Progressive MS

Disability Worsening

Time

Adapted from Kretzschmar A., MSVirtual2020; *Lublin FD, et al. Brain. 2022 Sep 14;145(9):3147-3161

MS: multiple sclerosis; MRI: magnetic resonance imaging; RRMS: relapsing-remitting MS; SPMS: secondary progressive MS; aSPMS: active SPMS

Disclaimer

Immunic Inc. published this content on March 07, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 07, 2025 at 13:36:27.114.