Form 8-K

8-K — IMMUNIC, INC.

Accession: 0001193805-26-000703

Filed: 2026-05-28

Period: 2026-05-28

CIK: 0001280776

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — e665514_8k-immunic.htm (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May

28, 2026

IMMUNIC, INC.

(Exact name of registrant as specified in its

charter)

Delaware

001-36201

56-2358443

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

1200 Avenue of the Americas, Suite 200

New York, NY 10036

USA

(Address of principal executive offices)

Registrant’s telephone number, including

area code: (332) 255-9818

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of exchange on which registered

Common Stock, par value $0.0001

IMUX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of

the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant

to Section 13(a) of the Exchange Act. Yes ☐ No ☐

Item 7.01. Regulation FD Disclosure

On May 28, 2026, Immunic, Inc. (the “Company”

or “Immunic”) issued a press release (the “Press Release”) announcing the presentation of one late-breaking

and two additional posters highlighting 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) (collectively, the “Presentation”),

at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, taking place May 27-29, 2026, in Charlotte, North Carolina.

On May 28, 2026, Immunic posted the Presentation on the Company's website.

The Press Release and Presentation are attached

as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, respectively, and are incorporated herein by reference.

The information in Item 7.01 of this Current Report

on Form 8-K and Exhibit 99.1 and Exhibit 99.2 attached hereto shall not be deemed “filed” for the purposes of Section 18 of

the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section,

nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange

Act, except as shall be expressly set forth therein.

Cautionary Note Regarding Forward-Looking

Statements

Certain statements in this Current Report on Form

8-K, the Press Release and the Presentation are “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 Current Report on Form 8-K, the Presentation, and the 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 Current Report on Form 8-K, the Press Release, and

the Presentation speaks only as of the date of this Current Report on Form 8-K, the Press Release, and the Presentation. 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 Current Report on Form 8-K, the Press Release, and the Presentation.

Item 9.01. Financial Statements and Exhibits.

Exhibit

Description

99.1

Press Release, dated May 28, 2026.

99.2

Presentation, dated May 28, 2026.

104

Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of

1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

Dated: May 28, 2026

Immunic, Inc.

By:

/s/ Daniel Vitt

Daniel Vitt

Chief Executive Officer

EX-99.1

Filename: e665514_ex99-1.htm · Sequence: 2

Immunic to Present Additional

Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive Multiple

Sclerosis

–

Late-Breaking Poster Introduces New Unified Statistical Analyses for Assessing Confirmed Disability Changes for Trials in Progressive

Multiple Sclerosis –

–

Additional CALLIPER Data Further Highlight Vidofludimus Calcium’s Favorable Safety and Tolerability Profile; Patient-Reported Outcomes

Assessments Show No Negative Impact on Mood –

NEW

YORK, May 28, 2026 – Immunic, Inc. (Nasdaq:

IMUX), a late-stage biotechnology company pioneering the development of novel

oral therapies for neurologic diseases, today announced the presentation of one late-breaking and two additional posters highlighting

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 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting,

taking place May 27-29, 2026 in Charlotte, NC. All poster presentations will be accessible on the "Events and Presentations"

section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, Immunic

team members will be available throughout the meeting at booth #307.

“We believe the new data presented in these

three posters at the prestigious CMSC Annual Meeting continues to demonstrate a consistent and differentiated profile for vidofludimus

calcium in multiple sclerosis (MS),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “The late-breaking analysis

is particularly interesting, as it introduces a new and potentially more comprehensive way to measure overall disability change by capturing

both slowing of progression and improvement of disease. Together with supportive safety, tolerability and patient-reported data, these

findings further strengthen our confidence in the potential of vidofludimus calcium to address key drivers of MS disease progression.”

“These post-hoc analyses from the phase

2 CALLIPER trial provide valuable insights as to the effects of vidofludimus calcium in patients with progressive MS,” added Michael

A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. “Whereas disability in MS is commonly measured by 3- or 6-months confirmed

disability worsening, our late-breaking poster presents a novel approach capturing both worsening and improvement on treatment, allowing

for a more comprehensive assessment of well-being. In applying these assessments, we observed favorable effects of vidofludimus calcium

versus placebo. These data, combined with a safety and tolerability profile that appears favorable, supports the continued development

of vidofludimus calcium for progressive MS.”

Late-Breaking Poster Presentation Details:

· Poster Title: Novel Unified Statistical

Analyses for Confirmed Disability Changes in Multiple Sclerosis for Capturing Possible Neuroprotective Effects

· Presenting Author: James Myles, Global

Head of Biostatistics at Immunic

· Abstract ID: 11244

· Poster Board Label: LBA14

· Session Date: Thursday,

May 28, 2026

· Session Time: 5:00-7:00

pm ET

· Location: Exhibit Hall

This late-breaking poster introduces a novel unified

endpoint, Confirmed Disability Change (CDC), designed to capture both confirmed disability worsening (CDW) and confirmed disability improvement

(CDI) within a single statistical framework. Three complementary statistical approaches, including ordinal categorical analysis, time-to-event

modeling and Markov state change modeling, were applied post-hoc to data from the phase 2 CALLIPER trial in PMS. Across these models,

results consistently favored vidofludimus calcium over placebo.

These findings suggest that the CDC approach may

provide a more complete view of disability trajectories in PMS than conventional one-direction analyses, particularly for evaluating possible

neuroprotective effects. Broader adoption of such an integrated endpoint may improve statistical power in future clinical trials and help

better capture treatment benefits for patients with PMS.

Poster Presentation Details:

· Poster Title: Effect of Vidofludimus

Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor, on Patient-Reported Outcomes (PRO) in Progressive MS: Data from Phase

2 CALLIPER Trial

· Presenting Author: Julie Korich,

Ph.D., Senior Medical Director, Medical Affairs at Immunic

· Abstract ID: 10843

· Poster Board Label: DMT10

· Session Date: Thursday,

May 28, 2026

· Session Time: 5:00-7:00

pm ET

· Location: Exhibit Hall B

This poster presents patient-reported outcomes

from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, including measures of severity of depressive thoughts (Patient Health

Questionnaire-9, PHQ-9) and overall treatment satisfaction (Treatment Satisfaction Questionnaire for Medication), collected over the treatment

period of up to 120 weeks.

Analyses using a mixed model repeated measures

(MMRM) approach showed that changes in PHQ-9 scores were similar between vidofludimus calcium and placebo across all assessed timepoints,

including weeks 48, 72 and 120. At week 48, PHQ-9 scores numerically improved in both groups (vidofludimus calcium: -0.786 vs. placebo:

-0.347), with a similar pattern observed at week 72 (vidofludimus calcium:

-0.568 vs. placebo: -0.609) and week 120 (vidofludimus calcium: -1.777 vs. placebo: -0.525). There was no indication of worsening depressive

or suicidal thoughts with vidofludimus calcium (n=235) as compared to placebo (n=232) through 120 weeks.

Patient-reported treatment effectiveness numerically

favored vidofludimus calcium over placebo, particularly in perceived effectiveness at both week 48 (77.51 vs. 72.88) and week 120 (84.69

vs. 79.20), while side effect burden remained comparable between the treatment groups at both timepoints (97.65 vs. 97.70 at week 48 and

99.44 vs. 99.36 at week 120). Although exploratory in nature, these findings support a favorable patient-reported profile for vidofludimus

calcium over two years.

Presentation Details:

· Poster Title: Safety and Tolerability

of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor: Data from Phase 2 CALLIPER Trial

· Presenting Author: Alex Lublin, Ph.D.,

Senior Medical Director, Medical Affairs at Immunic

· Abstract ID: 10995

· Poster Board Label: DMT11

· Session Date: Thursday,

May 28, 2026

· Session Time: 5:00-7:00

pm ET

· Location: Exhibit Hall B

This poster provides an overview of safety and

tolerability data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, based on 467 patients treated for up to 120 weeks.

The overall incidence of treatment-emergent adverse

events (TEAEs) was comparable between vidofludimus calcium (69.4%) and placebo (68.5%). The most commonly reported events, including urinary

tract infection, headache and back pain, occurred at similar or lower rates in the vidofludimus calcium arm compared to placebo. TEAEs

leading to discontinuation were identical at 2.6% in both groups. Liver-related TEAEs were uncommon and similar between vidofludimus calcium

and placebo (5.2% vs. 5.5%), with no cases meeting Hy’s law criteria. Serious adverse events were observed at low and comparable

rates between groups (8.1% vs. 6.5%). Rates of infections and infestations as well as renal or urinary events were also similar between

groups.

The collective data set shows a similar overall

adverse events profile between vidofludimus calcium and placebo. These results are consistent with previous clinical experience and support

the favorable safety and tolerability profile of vidofludimus calcium in patients with PMS.

About Vidofludimus Calcium (IMU-838)

Vidofludimus calcium is an orally administered

investigational small molecule drug, currently in late-stage clinical trials for multiple sclerosis (MS). Vidofludimus calcium has a unique

mode of action designed to combine neuroprotective, anti-inflammatory and anti-viral effects to address key biological drivers of MS.

As a selective immune modulator, it activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which has been

associated with direct and indirect neuroprotective effects. Additionally, vidofludimus calcium is a highly selective inhibitor of the

enzyme dihydroorotate dehydrogenase (DHODH), which has been associated with anti-inflammatory and anti-viral effects. Vidofludimus calcium

is currently being evaluated in the phase 3 ENSURE trials for the treatment of relapsing MS. In the phase 2 EMPhASIS trial, it showed

therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in

reducing confirmed disability worsening. In the phase 2 CALLIPER trial in progressive MS patients, vidofludimus calcium showed promising

clinical signals, including reductions in confirmed disability progression and statistically significant confirmed disability improvement.

To date, more than 3,400 individuals have been exposed to vidofludimus calcium and it has shown a favorable pharmacokinetic, safety and

tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country and its efficacy, safety and tolerability are

still being evaluated in ongoing clinical trials.

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 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 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-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative,

chronic inflammatory, and autoimmune-related 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 macroeconomic 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

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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Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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Period Type:

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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Data Type:

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Balance Type:

Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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