Immunic Presents New Clinical, Biomarker, and Preclinical Data for Vidofludimus Calcium in Four Poster Presentations at MSToronto2026 - the 10th Joint ACTRIMS-ECTRIMS Meeting

Exploratory disability and biomarker findings accompany a planned Phase 3 program, following CALLIPER's missed primary endpoint.

Rhea-AI Summary

Immunic (IMUX) is presenting new clinical, biomarker and preclinical findings for investigational vidofludimus calcium in four posters at MSToronto2026.

Phase 2 CALLIPER extension analyses showed maintained favorable disability trends among patients continuing treatment; 6.5% discontinued through January 27, 2026. Exploratory analyses found reduced Epstein-Barr virus-specific immune signatures, with reductions associated with improved processing-speed scores. Post-hoc disability analyses favored treatment over placebo, while preclinical findings suggested neuronal protection requiring Nurr1, a protein involved in gene regulation. CALLIPER did not meet its primary brain-volume endpoint.

Immunic expects to initiate Phase 3 testing in progressive multiple sclerosis later in 2026 and report top-line results from its fully enrolled Phase 3 ENSURE trials in relapsing multiple sclerosis by year-end 2026.

11 points · 0 major

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1 major · 5 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Progressive MS Phase 3 initiation is expected later in 2026.
• Minor pointCALLIPER extension maintained favorable disability trends among participants continuing vidofludimus calcium treatment.
• Minor point6.5% discontinued through January 27, 2026; extension safety appeared consistent with the double-blind period.
• Minor pointEBV-specific immune sequence matches fell versus placebo by 0.65 in exploratory analysis (p=0.0004).
• Minor pointReduced EBV-specific immune signatures were associated with improved processing-speed scores across patients in post-hoc analysis.

6 minor points

• Minor point24-week confirmed disability improvement was 2.47 times more likely with treatment in post-hoc analysis (nominal p=0.037).
• Minor pointCombined disability-change analysis favored treatment in a proposed post-hoc model (nominal p=0.042).
• Minor pointBetter disability outcomes were 1.5 times more likely versus placebo using post-hoc pairwise comparisons (p=0.042).
• Minor pointPreclinical neuronal survival required Nurr1; findings also suggested reduced immune-cell-driven neuronal loss.
• Minor pointMouse models showed reduced disease severity and nerve-injury marker levels, with increased neurotrophic-factor levels and Nurr1-regulated gene expression.
• Minor point. Forward-looking: it has not happened yet and may not happen.Fully enrolled ENSURE Phase 3 trials in relapsing MS have top-line results expected by year-end 2026.

Negative

• Major pointCALLIPER's primary endpoint of percent brain volume change was not met.
• Minor pointNew disability and biomarker analyses include exploratory and post-hoc findings; combined disability measures remain proposed methods.
• Minor pointDouble-blind adverse events occurred in 69.4% versus 68.5% on placebo; serious events occurred in 8.1% versus 6.5%.
• Minor pointExtension adverse events affected 44.4% of 387 participants, including serious events in 5.7% and liver-related events in 3.1%.
• Minor pointAdverse events led to discontinuation in 1.8% of extension participants.

Key Figures

CALLIPER OLE discontinuations: 6.5% EBV-specific TRB sequence matches: -0.65 matches; p=0.0004 Influenza A-specific matches: +0.08 matches; p=0.5983 +3 more

CALLIPER OLE discontinuations

6.5%

Through the January 27, 2026 data cutoff

EBV-specific TRB sequence matches

-0.65 matches; p=0.0004

Exploratory CALLIPER analysis versus placebo

Influenza A-specific matches

+0.08 matches; p=0.5983

Exploratory CALLIPER analysis versus placebo

24-week confirmed disability improvement

2.47 times more likely; nominal p=0.037

CALLIPER post-hoc CDC analysis

Better outcome

1.5 times more likely; p=0.042

CALLIPER post-hoc GPC analysis versus placebo

CALLIPER randomized patients

467 patients

Phase 2 trial in primary or secondary progressive MS

Historical Context

1 past event · Latest: Oct 07

1 event

1. Oct 07

   clinical data

   24h Move

   -2.4%

   Preview disclosed week-48 disability trends, EBV findings, and proposed-endpoint results from CALLIPER.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

open-label extension, expanded disability status scale, tcrβ chain

3 terms

open-label extension medical

"New Phase 2 CALLIPER Open-Label Extension Data"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

expanded disability status scale medical

"on the Expanded Disability Status Scale (EDSS) score"

A clinical scale used by doctors to rate a person's level of physical disability, especially for tracking progression of long-term neurological conditions. It assigns a score based on mobility, coordination and daily function—like a report card for how well someone can move and care for themselves—and is widely used in medical trials to show whether a treatment slows or reverses decline. Investors watch these scores because changes can signal a drug’s effectiveness, regulatory outcomes, market approval prospects and future sales.

tcrβ chain medical

"EBV-specific TCRβ chain (TRB) sequence matches versus placebo-treated patients"

The TCRβ chain is the beta polypeptide subunit of a conventional T‑cell receptor, which pairs with a TCRα chain to form the receptor on the surface of most T lymphocytes. Its gene segments (V, D, J and C) are somatically rearranged during T‑cell development to create a variable region—especially the CDR3 loop—that, together with the paired alpha chain, recognizes peptide antigens presented by major histocompatibility complex (MHC) molecules; the beta chain provides part of the antigen‑binding site and contributes to the receptor’s specificity and signaling.

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– New Phase 2 CALLIPER Open-Label Extension Data Support Durability of Disability Outcomes Observed During the Double-Blind Period With Continued Vidofludimus Calcium Treatment; Safety and Tolerability Profile Appeared Consistent With That Observed in the Double-Blind Period –

– New Preclinical Data Suggest Nurr1-Dependent Neuronal Survival and Neuroprotective Effects Beyond DHODH Inhibition –

– Exploratory and Post-hoc CALLIPER Analyses Show Significant Reductions in EBV-Specific T-Cell Receptor Signatures; Observed Reductions Associated With Increased Symbol Digit Modalities Test (SDMT) Scores –

– Post-hoc Analysis of CALLIPER Using a Proposed Novel Disability Measure Suggests Overall Benefit of Vidofludimus Calcium in Progressive Multiple Sclerosis Patients –

NEW YORK, Oct. 21, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced that new clinical, biomarker, and preclinical data for its lead investigational asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), are being presented across four poster presentations at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting, taking place October 21-23, 2026, in Toronto. All posters are available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, the team is available throughout the event at booth #516.

"The data presented at MSToronto2026 provide complementary clinical and mechanistic evidence supporting the differentiated profile of vidofludimus calcium across the multiple sclerosis (MS) spectrum," said Erik Lundgren, Chief Executive Officer of Immunic. "Importantly, the new CALLIPER open-label extension (OLE) analyses provide favorable long-term follow-up of the disability signals observed during the double-blind treatment period, while the Nurr1, Epstein-Barr virus (EBV), and disability endpoint analyses provide additional insight into the biology of disease progression and how treatment effects may be more comprehensively measured. Together, these findings further support the clinical and scientific rationale for our planned Phase 3 program in progressive MS, which we expect to initiate later this year, while we also approach the top-line results from our fully enrolled Phase 3 ENSURE trials in relapsing MS, expected by year-end 2026."

New Phase 2 CALLIPER Open-Label Extension Data Support Durability of Disability Outcomes

Poster Title: Evaluation of Disability Outcomes from the Open-Label Extension of CALLIPER: A Phase 2 Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis

• Lead Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio and Coordinating Investigator of the CALLIPER trial
• Presentation: Paper Poster, Poster Number P0387
• Date and Time: Poster Session 1, Wednesday, October 21, 2026, 4:30 - 6:30 pm ET

New analyses of the Phase 2 CALLIPER trial showed that the favorable trends on disability outcomes observed during the double-blind main treatment period were maintained during the OLE phase among participants who continued vidofludimus calcium treatment. Only 6.5% of patients discontinued through the January 27, 2026 data cutoff, with a safety and tolerability profile that appeared consistent with that observed in the double-blind period.

Preclinical Models Suggest Nurr1-Dependent Neuronal Survival and Neuroprotective Effects

Poster Title: Vidofludimus Calcium Requires Nurr1 to Promote Neuronal Survival In Vitro and Is Associated with Neuroprotective Effects in Murine Models of Multiple Sclerosis

• Lead Author: Mehrnoosh Jafari, Senior Manager Translational Pharmacology at Immunic
• Presentation: Paper Poster, Poster Number P1273
• Date and Time: Poster Session 2, Thursday, October 22, 2026, 4:30-6:30 pm ET

New preclinical findings across multiple models suggest that vidofludimus calcium promotes neuronal survival under apoptotic stress conditions, an effect requiring Nurr1, and in addition reduces microglia-driven neuronal loss, supporting direct and indirect neuroprotective mechanisms. Under in vitro apoptotic conditions, vidofludimus calcium promoted neuronal survival, an effect not observed with teriflunomide, suggesting that the observed pro-survival effect involves mechanisms beyond DHODH inhibition.

Vidofludimus calcium also reduced disease severity and plasma neurofilament light (NfL) chain levels in murine experimental autoimmune encephalomyelitis (EAE) models, and increased brain-derived neurotrophic factor (BDNF) levels and expression of Nurr1-regulated target genes, providing additional evidence consistent with activation of Nurr1-pathways.

Taken together, these findings provide further preclinical evidence of the profile of vidofludimus calcium on pathways associated with neuroprotective effects.

Exploratory and Post-hoc CALLIPER Analyses Link Reduced EBV-Specific T-Cell Signatures with Improved Cognitive Performance as Measured by the Symbol Digit Modalities Test

Poster Title: Anti-EBV T-cell Receptor Repertoire Reduction Is Linked to Enhanced Cognitive Performance in Progressive Multiple Sclerosis: Evidence from the Phase 2 CALLIPER Trial with Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor

• Lead Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
• Presentation: ePoster, Number EP2473
• Date and Time: ePoster screens within the congress center and on the congress platform for the duration of the congress

An exploratory CALLIPER analysis found that vidofludimus calcium significantly reduced EBV-specific TCRβ chain (TRB) sequence matches versus placebo-treated patients (-0.65 matches; p=0.0004), while influenza A-specific matches were unchanged (+0.08; p=0.5983), suggesting an EBV-selective rather than generalized effect on the T-cell repertoire, consistent with a lowered rate of EBV reactivations. Across all patients, reductions in EBV-specific TRB matches were associated with improved Symbol Digit Modalities Test (SDMT, broadly used to assess processing speed) scores, as assessed in a post-hoc analysis. Safety and tolerability data from the CALLIPER trial are summarized below.

These exploratory findings support further investigation of the relationship between EBV-related immune activity and cognitive function in progressive MS.

Novel CALLIPER Analyses Evaluate Disability Improvement and Worsening Together

Poster Title: Bidirectional Disability Changes in Progressive Multiple Sclerosis Patients: a Proposed Endpoint to Capture Full Treatment Effects

• Lead Author: James Myles, Global Head of Biostatistics at Immunic
• Presentation: ePoster, Number EP2205
• Date and Time: ePoster screens within the congress center and on the congress platform for the duration of the congress

Traditional progressive MS analyses have focused primarily on delaying confirmed disability worsening, with improvement often not captured fully or assessed separately. This analysis evaluates two novel statistical models, Confirmed Disability Change (CDC) and Generalized Pairwise Comparisons (GPC), as proposed methods to integrate confirmed disability worsening and improvement into a single statistical analysis measure.

Applying both methods to CALLIPER post-hoc, progressive MS patients treated with vidofludimus calcium appeared more likely to have positive outcomes as compared to placebo, suggesting these methods may capture the true bidirectional disability trajectory of patients. The CDC method fits an ordinal logistic regression model to three ordered categories of confirmed disability change. Using data from the CALLIPER trial, patients treated with vidofludimus calcium were 2.47 times more likely to experience 24-week confirmed disability improvement (CDI) (nominal p=0.037), and a positive CDC (nominal p=0.042). The GPC method compares all pairs of patients to determine which patient had a better outcome as measured by improvement, stability, or slowed worsening on the Expanded Disability Status Scale (EDSS) score. By this method, patients on vidofludimus calcium were 1.5 times more likely to have a better outcome than those who received placebo, a statistically significant and clinically meaningful result (p=0.042).

These outcomes support further evaluation of a bidirectional endpoint designed to capture treatment effects across both disability worsening and improvement.

About Vidofludimus Calcium (IMU-838) and the CALLIPER Trial
Vidofludimus calcium (IMU-838) is an investigational oral small molecule activating nuclear receptor-related 1 (Nurr1) and selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). It is currently being evaluated in the Phase 3 ENSURE trials in relapsing multiple sclerosis (MS). More than 3,500 individuals have been exposed to vidofludimus calcium, to date.

The Phase 2 CALLIPER trial randomized 467 patients with primary or secondary progressive MS 1:1 to 45 mg once-daily vidofludimus calcium or placebo. While the primary endpoint of percent brain volume change (PBVC) was not met, exploratory imaging and clinical outcomes showed directionally favorable signals. Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were similar to placebo (69.4% vs. 68.5% and 8.1% vs. 6.5%, respectively), with no new safety signals and no Hy's law range cases observed. Among the 387 participants who entered the OLE phase, 44.4% experienced at least one TEAE, including 5.7% who experienced a serious TEAE. Liver-related TEAEs occurred in 3.1% of participants, and TEAEs leading to discontinuation in 1.8%.

Vidofludimus calcium (IMU-838) is an investigational medicinal product that has not been approved or authorized by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other regulatory authority for any indication in any jurisdiction. Its safety and efficacy have not been established. Any clinical, biomarker, or preclinical findings described reflect investigational data and are not intended to suggest that vidofludimus calcium is safe or effective for any use.

About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently being evaluated in Phase 3 clinical trials for the treatment of relapsing multiple sclerosis, with top-line data expected to be available by the end of 2026. Initiation of an additional Phase 3 clinical trial in progressive MS is expected later in 2026. Vidofludimus calcium has already shown therapeutic potential and a favorable safety and tolerability profile in Phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory Phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
LifeSci Advisors
Joyce Allaire
immunic@lifesciadvisors.com

US Media Contact
Real Chemistry
media@imux.com

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SOURCE Immunic, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Immunic's CALLIPER extension show for vidofludimus calcium?

The extension showed maintained favorable disability trends among patients who continued vidofludimus calcium after the double-blind period. Through the January 27, 2026 data cutoff, 6.5% had discontinued. Safety and tolerability appeared consistent with the double-blind period.

When does Immunic expect its next vidofludimus calcium Phase 3 milestones?

Immunic expects top-line ENSURE results by year-end 2026 and initiation of a Phase 3 progressive multiple sclerosis program later in 2026. The ENSURE trials in relapsing multiple sclerosis are fully enrolled.

How was Immunic's CALLIPER trial designed?

CALLIPER randomized 467 patients with primary or secondary progressive multiple sclerosis in a 1:1 ratio to 45 mg once-daily vidofludimus calcium or placebo. The primary endpoint measured percent brain volume change; 387 participants entered the open-label extension.

Did Immunic's EBV biomarker analysis show a generalized effect on immune signatures?

The exploratory analysis suggested an EBV-selective rather than generalized effect on the measured T-cell receptor signatures. Influenza A-specific sequence matches were unchanged (+0.08; p=0.5983), unlike the reduction in EBV-specific matches.