Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the ACTRIMS Forum 2026, Reinforcing Its Potential in Progressive Multiple Sclerosis

Rhea-AI Summary

Immunic (Nasdaq: IMUX) will present additional Phase 2 CALLIPER data for vidofludimus calcium at ACTRIMS Forum 2026 (Feb 5-7, San Diego). Poster data report statistically significant MRI improvements versus placebo (reduced Gd+ lesions, lower new/enlarging T2 lesion rates, T2 volume reductions, fewer SELs) and a significant decline in EBV-specific T-cell receptor matches (p=0.0004) in an 87-patient subset, suggesting antiviral activity and effects on both acute and chronic CNS inflammation.

Positive

• Gd+ lesions fell from 16.4% baseline to 7.0% at week 72 and 0% at week 120 for treated patients
• New/enlarging T2 lesions: 18.5% (vidofludimus) vs 30.0% (placebo) at week 72
• T2 lesion volume change favored vidofludimus with statistical significance at weeks 48 (p<0.05), 72 (p<0.005), 96 (p<0.05)
• Slowly expanding lesions (SEL) count significantly lower at week 96 (LS means 2.935 vs 3.840; p<0.05)
• EBV-specific T-cell receptor matches declined on vidofludimus versus placebo in an 87-patient subset (p=0.0004)

Negative

• EBV TCR analyses derive from a limited subset of 87 participants, restricting generalizability
• No clinical disability or functional outcome data were reported in these poster summaries to confirm clinical benefit

News Market Reaction – IMUX

-5.43%

2 alerts

-5.43% News Effect

-6.1% Trough Tracked

-$5M Valuation Impact

$78.87M Market Cap

0.0x Rel. Volume

On the day this news was published, IMUX declined 5.43%, reflecting a notable negative market reaction. Argus tracked a trough of -6.1% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $78.87M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Gd+ lesions baseline: 16.4% Gd+ lesions week 72: 7.0% vs 11.7% Gd+ lesions week 120: 0% vs 2.9% +5 more

8 metrics

Gd+ lesions baseline 16.4% Proportion of PMS patients with Gd+ lesions at baseline (both arms)

Gd+ lesions week 72 7.0% vs 11.7% Vidofludimus calcium vs placebo at week 72

Gd+ lesions week 120 0% vs 2.9% Vidofludimus calcium vs placebo at week 120

New/enlarging T2 lesions 18.5% vs 30.0% Proportion with new/enlarging T2 lesions at week 72

T2 lesion volume p-value p<0.005 Statistical significance for T2 lesion volume at week 72

SEL least squares means 2.935 vs 3.840 Slowly expanding lesions at week 96 (vidofludimus vs placebo)

CALLIPER subset size 87 patients EBV-focused subset (44 placebo, 43 vidofludimus calcium)

EBV TCR comparison p-value p=0.0004 Difference in EBV-specific TCR matches between treated and placebo

Market Reality Check

Price: $1.1600 Vol: Volume 933,428 is below t...

low vol

$1.1600 Last Close

Volume Volume 933,428 is below the 20-day average of 1,538,733, suggesting limited pre-news positioning. low

Technical Shares at 0.6557, trading below the 0.81 200-day moving average and well under the 52-week high of 1.39.

Peers on Argus

IMUX was up 0.28% while key biotech peers showed mixed moves (e.g., IRD +2.56%, ...

IMUX was up 0.28% while key biotech peers showed mixed moves (e.g., IRD +2.56%, IGMS -2.31%, ABOS -1.53%), pointing to a stock-specific reaction rather than a coordinated sector move.

Previous Clinical trial Reports

5 past events · Latest: Jun 24 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jun 24	RRMS OLE data	Positive	+0.0%	Long-term EMPhASIS OLE data showed high freedom from disability worsening.
Jun 05	ENSURE enrollment, CALLIPER	Positive	-0.3%	ENSURE Phase 3 enrollment completion and additional positive CALLIPER data.
Apr 30	CALLIPER top-line	Positive	-22.6%	Phase 2 CALLIPER showed disability risk reductions in progressive MS.
Nov 13	IMU-856 Phase 1/1b	Positive	+1.7%	Phase 1/1b IMU-856 data in celiac disease with favorable safety profile.
Oct 22	ENSURE futility pass	Positive	-9.7%	Phase 3 ENSURE program passed interim futility and continued as planned.

Pattern Detected

Clinical trial updates for vidofludimus calcium and IMU-856 have generally been positive, yet IMUX has often traded lower on these catalysts, indicating a pattern of negative or muted price reactions to favorable clinical news.

Recent Company History

Over the past year, Immunic has repeatedly reported constructive clinical milestones. Phase 2 EMPhASIS OLE data in RRMS at Week 144 showed >92% of patients free of confirmed disability worsening. Multiple CALLIPER readouts in progressive MS highlighted disability risk reductions and neuroprotective signals, while the ENSURE Phase 3 program cleared an interim futility analysis and continued unchanged. Despite these developments, several clinical-trial headlines were followed by negative price moves, suggesting investor focus on other factors such as risk perception or funding needs when evaluating Immunic’s progress.

Historical Comparison

-6.2% avg move · In the past, IMUX clinical trial headlines (5 events) saw an average move of -6.17%, often negative ...

clinical trial

-6.2%

Average Historical Move clinical trial

In the past, IMUX clinical trial headlines (5 events) saw an average move of -6.17%, often negative despite positive data. Today’s modest 0.28% gain on new CALLIPER results is less extreme than prior same-tag reactions.

Clinical updates show a trajectory from Phase 2 EMPhASIS in RRMS, to multiple Phase 2 CALLIPER readouts in progressive MS, alongside advancement of Phase 3 ENSURE trials in relapsing MS and early-stage IMU-856 data in celiac disease.

Market Pulse Summary

The stock moved -5.4% in the session following this news. A negative reaction despite favorable CALL...

Analysis

The stock moved -5.4% in the session following this news. A negative reaction despite favorable CALLIPER data would fit a pattern where positive clinical readouts coincided with negative average moves of -6.17% across prior trial headlines. The new MRI and EBV T-cell data further support vidofludimus calcium’s biological activity, but investors have previously focused on balance-sheet and listing risks, which could overshadow incremental efficacy signals and contribute to selling pressure following good news.

Key Terms

gadolinium-enhancing (gd+), magnetic resonance imaging (mri), slowly expanding lesions (sel), epstein-barr virus (ebv), +4 more

8 terms

gadolinium-enhancing (gd+) medical

"The proportion of patients in the vidofludimus calcium group with gadolinium-enhancing (Gd+)"

Gadolinium-enhancing (gd+) describes areas on an MRI scan that pick up a gadolinium contrast dye, indicating active inflammation or a recent breach in the blood–brain barrier. Investors care because gd+ lesions are a widely used, objective sign that a neurological disease is currently active or responding to treatment, so changes in gd+ counts or size can drive clinical-trial results, regulatory decisions, and market expectations for drugs and imaging tools — like spotting fresh leaks by spraying a dye.

magnetic resonance imaging (mri) medical

"key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers"

A magnetic resonance imaging (MRI) scan is a medical camera that uses strong magnets and radio waves to create detailed pictures of the body’s organs and tissues without surgery or X-rays. Investors care because MRI machines and the services around them represent significant capital spending, recurring revenue from scans, and influence on clinical trials, hospital budgets, and healthcare reimbursements—factors that affect the financial outlook of medical device makers and providers.

slowly expanding lesions (sel) medical

"the number of slowly expanding lesions (SEL), an emergent indicator of chronic-compartmentalized inflammation"

Slowly expanding lesions (SEL) are areas of brain tissue damage that enlarge gradually over months or years, identified on repeated MRI scans in chronic neurological diseases. They matter to investors because SELs are used as a measurable sign of ongoing disease activity and treatment effect; a therapy that slows or stops SEL growth can improve chances of regulatory approval, payer acceptance and long‑term commercial value—think of SELs as a slow leak that shows whether a treatment truly fixes the underlying problem.

epstein-barr virus (ebv) medical

"including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging"

Epstein-Barr virus (EBV) is a common virus that causes infectious mononucleosis (“mono”) and can stay dormant in the body long-term, sometimes contributing to chronic symptoms or rare cancers. Investors care because EBV drives demand for diagnostics, treatments and vaccines, and outbreaks or new clinical trial results can affect the revenue and valuation of healthcare companies much like a supply or product breakthrough shifts a factory’s output and market prospects.

t-cell receptor (tcr) repertoire medical

"The applied methodology of measuring the so-called T-cell receptor (TCR) repertoire explores the overall diversity"

The T‑cell receptor (TCR) repertoire is the variety and abundance of molecular “keys” on a person’s T cells that recognize different infections, cancer cells or other threats. For investors, changes in the TCR repertoire can signal whether an immune therapy is engaging the body, identify which patients are likely to respond, or reveal safety issues — like watching the mix of keys shift can predict effectiveness and risk the way customer feedback predicts a product’s market fit.

nurr1 activator medical

"lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)"

A nurr1 activator is a drug or compound designed to boost the activity of the Nurr1 protein, a cellular switch that helps maintain certain brain cells. Think of it as turning up a thermostat to restore normal cell function; for investors, such activators matter because they can form the basis of new therapies that, if clinically proven and approved, may create significant commercial value or trigger sharp changes in a developer’s stock based on trial results and regulatory milestones.

dhohd inhibitor medical

"Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, on MRI Outcomes"

A DHODH inhibitor is a drug that blocks an enzyme cells use to make key building blocks for growth and replication; imagine cutting off the supply of bricks a factory needs to build new products. For investors, these drugs matter because they can slow overactive immune cells, viruses, or rapidly dividing cancer cells, so clinical trial results, safety, and regulatory decisions can drive significant changes in a company’s value and commercial prospects.

progressive multiple sclerosis (pms) medical

"in patients with progressive multiple sclerosis (PMS) at the Americas Committee"

A long-term form of multiple sclerosis in which neurological function steadily worsens over time rather than coming and going in attacks. Think of it as a slow, persistent leak in a house rather than occasional storms — symptoms accumulate and disability progresses. Investors watch this condition because it shapes demand for treatments, clinical trial complexity, regulatory approval paths and the long‑term market potential for drugs and devices aimed at slowing or managing progression.

AI-generated analysis. Not financial advice.

– Additional CALLIPER MRI Analyses Show Reductions for Vidofludimus Calcium in Acute and Chronic Inflammatory Disease Activity –

– CALLIPER Subset Data Demonstrate Reductions in EBV-Specific T-Cell Receptor Sequences, Underlining Broad-Spectrum Antiviral Effects of Vidofludimus Calcium –

NEW YORK, Feb. 4, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced the presentation of additional data from its phase 2 CALLIPER trial evaluating lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026, taking place from February 5-7, in San Diego, California. Both poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, members of Immunic's management, medical and preclinical teams will be available throughout the event at booth #N9.

"Together, our two poster presentations at the prestigious ACTRIMS Forum further underscore the unique mechanism of action of vidofludimus calcium and its potential in PMS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "These latest findings from our phase 2 CALLIPER trial provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in multiple sclerosis (MS) patients."

Presentation Details:

• Poster Title: Effect of Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, on MRI Outcomes in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER Trial
• Presenting Author: Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic
• Abstract Number: 555
• Poster Number: P130
• Poster Session: 1
• Session Date: Thursday, February 5, 2026
• Session Time: 5:45 pm – 7:30 pm PT (even-numbered posters present from 6:00-6:45 pm)

MRI lesions in the brain of MS patients are commonly understood to be markers of acute-focal inflammation. In patients with PMS enrolled in the phase 2 CALLIPER trial, treatment with vidofludimus calcium was associated with improvements across key MRI markers of both acute-focal and chronic-compartmentalized inflammation when compared to placebo.

The proportion of patients in the vidofludimus calcium group with gadolinium-enhancing (Gd+) lesions decreased from 16.4% at baseline (placebo: 16.4%) to 7.0% at week 72 (placebo: 11.7%) and 0% at week 120 (placebo: 2.9%). At week 72, the proportion of patients with new and/or enlarging T2 lesions was 18.5% for those in the vidofludimus calcium group vs. 30.0% for those in the placebo group. The difference in the mean change of T2 lesion volume in favor of vidofludimus calcium was statistically significant for weeks 48 (p<0.05), 72 (p<0.005), and 96 (p<0.05). Additionally, the difference in the number of slowly expanding lesions (SEL), an emergent indicator of chronic-compartmentalized inflammation in PMS patients, was statistically significant at week 96 between the vidofludimus calcium and placebo groups, with least squares means of 2.935 and 3.840 (p<0.05).

"These new MRI results from our phase 2 CALLIPER trial show evidence that vidofludimus calcium reduces radiographic hallmarks of both acute-focal and chronic-compartmentalized inflammation in patients with PMS," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. "The observed reductions further support the potential of vidofludimus calcium to influence compartmentalized central nervous system inflammation, which is believed to contribute to disability progression, in this progressive patient population."

Presentation Details:

• Poster Title: Effect of Vidofludimus Calcium, a Novel Nurr1 Activator and DHODH Inhibitor, on the Anti-EBV T-cell Receptor Repertoire in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER Trial
• Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
• Abstract Number: 411
• Poster Number: P024
• Poster Session: 1
• Session Date: Thursday, February 5, 2026
• Session Time: 5:45 pm – 7:30 pm PT (even-numbered posters present from 6:00-6:45 pm)

This poster presents data on the antiviral effects of vidofludimus calcium, specifically regarding EBV, a chronic viral infection known to be a precondition for MS and hypothesized to also play a role in disease progression.

In a subset of 87 phase 2 CALLIPER trial participants with PMS (44 placebo, 43 vidofludimus calcium), treatment effects on EBV reactivation before and during treatment were evaluated for vidofludimus calcium compared to placebo from day 1 through week 48. The applied methodology of measuring the so-called T-cell receptor (TCR) repertoire explores the overall diversity and composition of T-cell receptors. The sequences targeted against EBV-specific antigens were compared with Influenza A-virus (IAV) antigen targeted sequences as control. The presence of these matched sequences in the TCR repertoire is believed to reflect ongoing interaction of T-cells with these specific viruses, and, hence, are thought to be a reflection of ongoing active viral infection. EBV causes a chronic life-long virus infection with the general understanding that interactions between its antigens and T-cells are ordinarily restricted to periods of virus reactivations.

For tested CALLIPER patients on placebo, the EBV-specific matches remained stable over time, indicating persistent exposure of T-cells to EBV during the study. In contrast, patients treated with vidofludimus calcium showed a progressive decline of EBV-specific matches over time, consistent with a lowering of the rate of EBV reactivations during treatment. The comparison of actively treated and untreated patients was statistically significant (p=0.0004). For IAV-related matches used as control, no statistically significant change was observed between the groups.

"These findings from a subset of the phase 2 CALLIPER trial participants strengthen our hypothesis that the broad-spectrum antiviral effects of vidofludimus calcium can lead to lower EBV reactivations, potentially addressing MS disease progression related to ongoing EBV reactivations," added Dr. Muehler. "The findings warrant further investigation of the possible correlations between clinical outcomes of the CALLIPER trial and the anti-EBV T-cell response in patients."

About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis (MS). Uniquely, vidofludimus calcium's first-in-class, dual mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of MS. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for the treatment of relapsing MS. In a phase 2 clinical trial, it has shown therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. Additionally, vidofludimus calcium has demonstrated clinical benefits in progressive MS patients by showing substantial reductions in confirmed disability worsening and thalamic brain volume in a phase 2 clinical trial. To date, vidofludimus calcium has been exposed to approximately 2,700 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.

About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. 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). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal 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 timing of current and future clinical trials and anticipated clinical milestones; 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, and the ability to raise sufficient capital to continue as a going concern, 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, 2024, filed with the SEC on March 31, 2025, 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
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

 

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SOURCE Immunic, Inc.

FAQ

What MRI improvements did Immunic (IMUX) report from the Phase 2 CALLIPER trial at ACTRIMS 2026?

Vidofludimus calcium showed reductions in multiple MRI markers including Gd+ lesions, new/enlarging T2 lesions, T2 volume, and SELs. According to the company, several comparisons reached statistical significance at weeks 48–96, supporting effects on acute and chronic inflammation.

How did vidofludimus calcium affect EBV-specific T-cell receptor sequences in the CALLIPER subset (IMUX)?

Treatment was associated with a progressive decline in EBV-specific TCR matches versus placebo (statistically significant, p=0.0004). According to the company, this suggests lowered EBV reactivation rates in the 87-patient subset studied through week 48.

What were the specific findings for gadolinium-enhancing (Gd+) lesions in IMUX's CALLIPER data?

The proportion with Gd+ lesions fell from 16.4% at baseline to 7.0% at week 72 and 0% at week 120 in treated patients. According to the company, this indicates marked reduction in acute-focal inflammatory activity on MRI.

Did Immunic (IMUX) report statistical significance for T2 lesion volume changes in CALLIPER?

Yes. Mean change in T2 lesion volume favored vidofludimus with statistical significance at weeks 48 (p<0.05), 72 (p<0.005), and 96 (p<0.05). According to the company, these results support a treatment effect on overall lesion burden.

Will the CALLIPER findings presented by Immunic (IMUX) at ACTRIMS 2026 include clinical outcome data?

The presented posters focus on MRI and TCR biomarker analyses and do not report clinical disability outcomes. According to the company, the data strengthen biological hypotheses but further investigation is needed to link biomarkers to clinical benefit.