false
0001280776
0001280776
2025-08-07
2025-08-07
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): August
7, 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 2.02. Results of Operations and Financial Condition
On August 7, 2025, Immunic, Inc. (the “Company”)
issued a press release, a copy of which is furnished herewith as Exhibit 99.1, announcing the Company’s financial results for the
quarter ended June 30, 2025 and providing a corporate update (the “Press Release”).
The information contained in Item 2.02 of this
Current Report on Form 8-K, including the Press Release, shall not be deemed “filed” for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the
Securities Act of 1933, as amended. In addition, this information shall not be deemed incorporated by reference into any of the Company’s
filings with the Securities and Exchange Commission (the “SEC”), except as shall be expressly set forth by specific reference
in any such filing.
Item 8.01. Other Events
On August 7, 2025, the Company posted an updated
presentation (the “Presentation”) on its website. A copy of the Presentation is filed herewith as Exhibit 99.2 and is incorporated
herein by reference.
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 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 the Company’s development programs and the targeted diseases; the potential for the Company’s development programs to safely
and effectively target diseases; preclinical and clinical data for the Company development programs; 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 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. The Company 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 the Company’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.
The statements made in this Current Report on
Form 8-K, the Press Release and the Presentation speak only as of the date stated herein, and subsequent events and developments may cause
the Company’s expectations and beliefs to change. While the Company may elect to update these forward-looking statements publicly
at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future
events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s
views as of any date after the date stated herein.
Item 9.01. Financial Statements and Exhibits
| Exhibit |
Description |
| |
|
| 99.1 |
Press Release, dated August 7, 2025. |
| 99.2 |
Presentation, dated August 7, 2025. |
| 104 |
Cover Page to this Current Report on Form 8-K in 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: August 7, 2025 |
Immunic, Inc. |
| |
|
|
| |
By: |
/s/ Daniel Vitt |
| |
|
Daniel Vitt |
| |
|
Chief Executive Officer |
