8-K
IMMUNIC, INC. (IMUX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The SecuritiesExchange Act of 1934
Date of Report (Date of earliest event reported): February26, 2026
IMMUNIC, INC.
(Exact name of registrant as specified in itscharter)
| Delaware | 001-36201 | 56-2358443 |
|---|---|---|
| (State or other jurisdictionof 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, includingarea 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 February 26, 2026, 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 and year ended December 31, 2025 and providing a corporate update (the “Press Release”).
The information contained in Item 2.02 and Item 9.01 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, except as shall be expressly set forth by specific reference in any such filing.
Item 9.01. Financial Statements and Exhibits
| Exhibit | Description |
|---|---|
| 99.1 | Press Release, dated February 26, 2026 |
| 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: February 26, 2026 | Immunic, Inc. | |
|---|---|---|
| By: | /s/ Daniel Vitt | |
| Daniel Vitt | ||
| Chief Executive Officer |
Immunic, Inc. Reports Year-End 2025 FinancialResults and Provides Corporate Update
– Top-Line Data from Phase 3 ENSURETrials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 –
–Raised Proceeds of $200 Million in a Private Placement, with Potential for up to an Additional $200 Million –
–Net Proceeds Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in PrimaryProgressive Multiple Sclerosis and Begin of Transition into a Commercial Organization–
NEW YORK,February 26, 2026 – Immunic**, Inc. (Nasdaq:IMUX),**a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the year ended December 31, 2025, and provided a corporate update.
“The phase 3 ENSURE-1 and ENSURE-2 trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) continue to progress, with top-line data expected to be available by the end of 2026,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “As we continue to advance our multiple sclerosis (MS) program with vidofludimus calcium, we were extremely pleased to have recently announced the successful completion of an oversubscribed private placement of up to $400 million in gross proceeds, with $200 million in upfront gross proceeds. This financing is truly a pivotal milestone for Immunic and positions us to confidently transition into a fully integrated commercial-stage company. The transaction was led by our existing investor BVF Partners L.P. with participation from a group of highly regarded new and other existing investors. This level of commitment reflects growing confidence in our program and reinforces our belief in vidofludimus calcium’s potential to address the underlying drivers of MS progression.”
“The proceeds from the initial closing are expected to fund our operations through the ENSURE top-line data and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027, with a targeted potential regulatory approval date in 2028,” continued Dr. Vitt. “They also support preparations for the potential launch of vidofludimus calcium in RMS, including expansion of our medical and commercial infrastructure. Additionally, based on the totality of the phase 2 CALLIPER trial data in progressive MS, which showed not only substantial and medically relevant reductions for vidofludimus calcium in delaying 24-week confirmed disability progression but also statistically significant 24-week confirmed disability improvement, while confirming the drug’s favorable safety and tolerability profile already observed in previous clinical trials, we plan to initiate a confirmatory phase 3 program in primary progressive multiple sclerosis (PPMS) later this year as well.”
Jason Tardio, President and Chief Operating Officer of Immunic, added, “This is an exciting moment for Immunic and for individuals living with MS, as we believe that vidofludimus calcium could represent a potentially transformative approach to disease modification. Current oral therapies for RMS mainly control inflammation and relapses, often have complex safety and tolerability issues and do not adequately address the neurodegenerative processes driving disability progression and long-term disability. In contrast, vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through Nurr1 activation, while reducing new inflammatory damage via selective DHODH inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses. As such, we believe vidofludimus calcium may achieve a best-in-class benefit-risk profile and, therefore, could represent a large commercial opportunity in the global MS market, which is projected to reach over $30 billion by the early 2030s.”
Fourth Quarter 2025 and Subsequent Highlights
| · | February 2026: Completed an oversubscribed private placement of<br>up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity<br>Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners,<br>Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received<br>upon closing on February 17, 2026. |
|---|---|
| o | Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare<br>Diseases at Roche, elevated to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the<br>Board. Thor Nagel, Principal at BVF Partners L.P., appointed to the Board. Plans underway for further Board refreshment to support the<br>company’s evolution into a commercial-stage organization. |
| --- | --- |
| o | Initiated search for a new Chief Executive Officer with deep commercial<br>expertise in MS to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his<br>roots and transition to a new senior executive role focused on scientific strategy and portfolio<br>advancement, while remaining on the Board. |
| --- | --- |
| · | February 2026: Presented additional data from the phase 2 CALLIPER<br>trial of vidofludimus calcium in patients with progressive MS at the ACTRIMS Forum 2026. The findings, presented in two poster presentations,<br>provide additional evidence of vidofludimus calcium’s effects on key biological drivers of disease progression, including antiviral<br>immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized<br>inflammation. The findings further reinforce Immunic’s belief that vidofludimus calcium has the potential to address underlying<br>mechanisms of disease progression in MS patients. |
| --- | --- |
Anticipated Clinical Milestones
| · | Vidofludimus calcium in MS: |
|---|---|
| o | Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026.<br>Subsequently, Immunic plans to submit an NDA in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. |
| --- | --- |
| o | Initiation of a phase 3 clinical program in PPMS is expected later this year and estimated to take approximately<br>3.5 to 4 years to complete. |
| --- | --- |
| · | IMU-856: The company continues preparing for further clinical testing of IMU-856, contingent on<br>financing, licensing or partnering. |
| --- | --- |
Financial and Operating Results
| · | Research and Development (R&D) Expenses were $82.0 million for the twelve months ended December<br>31, 2025, as compared to $80.0 million for the twelve months ended December 31, 2024. The $1.9 million increase reflects (i) a $3.9 million<br>increase in external development costs related to the vidofludimus calcium program and (ii) a $1.8 million increase in personnel expenses<br>for R&D. The increase was offset by (i) a $3.0 million decrease in external development costs related to IMU-856 and (ii) a $0.8 million<br>decrease across numerous categories. |
|---|
| · | General and Administrative (G&A) Expenses were $21.2 million for the twelve months ended December<br>31, 2025, as compared to $18.0 million for the same period ended December 31, 2024. The $3.2 million increase was due to (i) a $1.9 million<br>increase related to personnel expenses, of which $0.3 million was related to non-cash stock compensation, (ii) a $0.8 million increase<br>in legal and consultancy expenses and (iii) a $0.5 million increase related to costs across numerous categories. |
|---|
| · | Interest Income was $1.0 million for the twelve months ended December 31, 2025, as compared to<br>$3.4 million for the twelve months ended December 31, 2024. The $2.4 million decrease was due to a lower average cash balance. |
|---|---|
| · | In the twelve months ended December 31, 2024, there was a non-cash charge related to the change in value<br>of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially<br>classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the company’s<br>authorized shares from 130 million to 500 million shares of common stock and, therefore, the tranche 2 and tranche 3 rights needed to<br>be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the<br>twelve months ended December 31, 2025. |
| --- | --- |
| · | Other Income (Expense) was $5.0 million for the twelve months ended December 31, 2025, as compared<br>to ($1.0 million) for the same period ended December 31, 2024. The $6.1 million increase was primarily attributable to (i) $4.8 million<br>of grant income from the German Federal Ministry of Finance, of which $1.0 million was recognized in the first quarter 2025 and $3.8 million<br>was recognized in the fourth quarter 2025, (ii) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing<br>related to the tranche rights that were established at the time of the deal closing in 2024 and (iii) a $0.3 million increase across numerous<br>categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia<br>due to lower clinical trial spend in Australia. |
|---|---|
| · | Net Loss for the twelve months ended December 31, 2025, was approximately $97.2 million, or $0.62<br>per basic and diluted share, based on 155,688,030 weighted average common shares outstanding, compared to a net loss of approximately<br>$100.5 million, or $1.00 per basic and diluted share, based on 100,174,766 weighted average common shares outstanding for the same period<br>ended December 31, 2024. |
| --- | --- |
| · | Cash and Cash Equivalents as of December 31, 2025 were approximately $15.5 million. With these<br>funds and the approximately $187.0 million net cash proceeds raised in the February 2026 private placement, Immunic expects to be able<br>to fund its operations into late 2027. |
| --- | --- |
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 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). 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, inflammatory bowel disease, and Graft-versus-Host-Disease. IMU-381 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging the company’s Nurr1 platform. For further information, please visit: www.imux.com.
CautionaryStatement 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 Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's 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, 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, 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, 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
Financials
Immunic, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
| Years Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | |||||
| Operating expenses: | ||||||
| Research and development | $ | 81,983 | $ | 80,046 | ||
| General and administrative | 21,245 | 18,006 | ||||
| Total operating expenses | 103,228 | 98,052 | ||||
| Loss from operations | (103,228 | ) | (98,052 | ) | ||
| Other income (expense): | ||||||
| Interest income | 1,040 | 3,390 | ||||
| Change in fair value of the tranche rights | — | (4,796 | ) | |||
| Other income (expense), net | 5,016 | (1,049 | ) | |||
| Total other income (expense), net | 6,056 | (2,455 | ) | |||
| Net loss | $ | (97,172 | ) | $ | (100,507 | ) |
| Net loss per share, basic and diluted | $ | (0.62 | ) | $ | (1.00 | ) |
| Weighted-average common shares outstanding, basic and diluted | 155,688,030 | 100,174,766 |
Immunic, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| 2024 | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 15,483 | $ | 35,668 | ||
| Prepaid expenses and other current assets | 7,386 | 3,664 | |||
| Total current assets | 22,869 | 39,332 | |||
| Property and equipment, net | 608 | 545 | |||
| Right of use asset, net | 575 | 991 | |||
| Total assets | 24,052 | $ | 40,868 | ||
| Liabilities and Stockholders’ Equity (Deficit) | |||||
| Current liabilities: | |||||
| Accounts payable | 10,138 | $ | 7,846 | ||
| Accrued expenses | 18,645 | 12,913 | |||
| Other current liabilities | 1,835 | 1,416 | |||
| Total current liabilities | 30,618 | 22,175 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities | 107 | 264 | |||
| Total long-term liabilities | 107 | 264 | |||
| Total liabilities | 30,725 | 22,439 | |||
| Commitments and contingencies | |||||
| Stockholders’ equity (deficit): | |||||
| Preferred stock, 0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at December 31, 2025 and 2024 | — | — | |||
| Common stock, 0.0001 par value; 500,000,000 shares authorized as of December 31, 2025 and December 31, 2024, respectively, and 120,382,625 and 90,150,869 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively. | 9 | 8 | |||
| Additional paid-in capital | 599,241 | 525,611 | |||
| Accumulated other comprehensive income | 2,648 | 4,209 | |||
| Accumulated deficit | (608,571 | ) | (511,399 | ) | |
| Total stockholders’ equity (deficit) | (6,673 | ) | 18,429 | ||
| Total liabilities and stockholders’ equity (deficit) | 24,052 | $ | 40,868 |
All values are in US Dollars.