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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): September
25, 2025
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 8.01. Other Events.
On September 25, 2025, Immunic, Inc. (the “Company”
or “Immunic”) issued a press release (the “Press Release”) announcing the presentation of key vidofludimus calcium data in an oral and four poster presentations (collectively,
the “Presentation”), at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS), being held September 24-26, 2025 in Barcelona, Spain. On September 24, 2025, Immunic posted a corporate presentation on the Company's website including new data from the Phase 2 CALLIPER
trial of vidofludimus calcium in progressive multiple sclerosis.
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 8.01 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 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, 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 Securities and Exchange Commission 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 Current Report on Form
8-K, the Press Release, or the Presentation speaks only as of the date of the Current Report on Form 8-K, the Press Release or the Presentation,
respectively. 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 September 25, 2025. |
| 99.2 |
Presentation, dated September 24, 2025. |
| 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: September 25, 2025 |
Immunic, Inc. |
| |
|
|
| |
By: |
/s/ Daniel Vitt |
| |
|
Daniel Vitt |
| |
|
Chief Executive Officer |
