Immunic (Nasdaq: IMUX) posts Q1 loss and $200 million private placement
Rhea-AI Filing Summary
Immunic, Inc. reported first quarter 2026 results and highlighted a large private financing to fund its multiple sclerosis programs. For the three months ended March 31, 2026, the company recorded a net loss of $32,588 thousand, driven by research and development expenses of $25,626 thousand and general and administrative expenses of $7,609 thousand.
In February, Immunic closed an oversubscribed private placement of up to $400 million in gross proceeds, with $200 million received upfront, which management expects to fund operations through completion of the phase 3 ENSURE trials in relapsing multiple sclerosis and a planned RMS New Drug Application submission in mid-2027. Cash and cash equivalents increased to $186,629 thousand as of March 31, 2026, and total stockholders’ equity improved to $151,233 thousand, reflecting the new capital despite ongoing operating losses.
Positive
- Oversubscribed financing strengthens balance sheet and runway: Immunic closed a private placement of up to $400 million in gross proceeds, with $200 million received upfront, lifting cash and cash equivalents to $186,629 thousand and stockholders’ equity to $151,233 thousand as of March 31, 2026.
Negative
- Widening operating losses as development scales: For the quarter ended March 31, 2026, total operating expenses rose to $33,235 thousand and net loss increased to $32,588 thousand, underscoring continued cash burn ahead of potential product revenue.
Insights
Large financing extends runway through pivotal MS data despite rising losses.
Immunic shows typical clinical-stage biotech economics: no product revenue, rising R&D, and a widening quarterly net loss of $32,588 thousand. Operating expenses reached $33,235 thousand in Q1 2026, reflecting late-stage trial activity and corporate build-out.
The key development is an oversubscribed private placement of up to $400 million, with $200 million already received. Management indicates this cash should fund phase 3 ENSURE trials in relapsing multiple sclerosis and a planned RMS New Drug Application in mid-2027. Cash and cash equivalents rose to $186,629 thousand, lifting stockholders’ equity to $151,233 thousand.
This materially reduces near-term financing risk while the company advances vidofludimus calcium in phase 3 and prepares for potential commercialization. Future updates on top-line ENSURE data expected by the end of 2026 and progress toward the RMS NDA will be central to assessing longer-term value.
8-K Event Classification
Key Figures
Key Terms
phase 3 ENSURE trials financial
New Drug Application (NDA) regulatory
oversubscribed private placement financial
dihydroorotate dehydrogenase (DHODH) technical
forward-looking statements regulatory
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02. Results of Operations and Financial Condition
On May 13 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 ended March 31, 2026, 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, 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 May 13, 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: May 13, 2026 | Immunic, Inc. | |
| By: | /s/ Daniel Vitt | |
| Daniel Vitt | ||
| Chief Executive Officer | ||
Immunic, Inc. Reports First Quarter 2026 Financial Results and Provides Corporate Update
– Appointed Globally Renowned Biopharmaceutical Executive and Neurology Drug Developer, Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer –
– Continued to Execute Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis, with Top-Line Data Expected by End of 2026 –
– Raised $200 Million in an Oversubscribed Private Placement, with Potential for up to an Additional $200 Million –
NEW YORK, May 13, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update.
“We are fast approaching a highly pivotal juncture, with the anticipated top-line data readout of the twin phase 3 ENSURE trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing multiple sclerosis (RMS), expected by the end of 2026,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “In anticipation, we strengthened our leadership team with the recent appointment of Dr. Michael A. Panzara as Chief Medical Officer. Mike brings deep expertise in neurology and a proven track record of advancing multiple sclerosis (MS) therapies through late-stage clinical development and global regulatory approvals. Additionally, we enhanced our Board of Directors with the appointment of Jon Congleton, who has nearly four decades of biopharmaceutical leadership experience. Earlier in the quarter, Simona Skerjanec, M.Pharm, M.B.A., who joined Immunic's Board of Directors in July 2024, has been elevated to interim Chairperson of the Board and Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board. Together, these key appointments are intended to best position the company for successful execution of our late-stage development priorities and prepare for potential commercialization.”
Dr. Vitt continued, “As important, in February, we closed an oversubscribed private placement financing of up to $400 million in gross proceeds, with $200 million received upfront. This highly successful transaction signals investors’ continued confidence in Immunic and has provided the resources we need to advance our programs through key milestones and to continue our transition into a commercial-stage company. The initial proceeds are expected to fund our operations through the completion of our phase 3 ENSURE trials in RMS and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027. The funds will also support continued investment in our development organization and launch readiness. At the same time, we remain focused on expanding the opportunity for vidofludimus calcium beyond RMS, which is supported by the growing body of data from our phase 2 CALLIPER trial in progressive MS (PMS) and our plan to initiate a confirmatory phase 3 program in primary progressive MS (PPMS) later this year.”
Jason Tardio, President and Chief Operating Officer of Immunic, added, “We believe vidofludimus calcium has the potential to offer a transformative approach to disease modification in MS. Unlike currently available oral therapies that primarily target inflammatory pathways, vidofludimus calcium is designed to deliver both direct neuroprotective effects through Nurr1 activation and anti-inflammatory activity via selective DHODH inhibition. In clinical trials to date, vidofludimus calcium has demonstrated a favorable safety and tolerability profile. Taken together, these attributes may support a compelling benefit-risk profile in the global MS market, which is projected to exceed $30 billion by the early 2030s.”
First Quarter 2026 and Subsequent Highlights
| · | April 2026: Appointed accomplished biopharmaceutical executive Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer, to lead the company’s development organization, including clinical development, medical affairs, and regulatory affairs. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A., who will continue to support the company as a consultant. |
| · | April 2026: Effected 1-for-10 reverse stock split of the outstanding shares of common stock as of April 27, 2026. |
| · | April 2026: Regained compliance with Nasdaq minimum bid price requirement (Rule 5550(a)(2)) for continued listing, following receipt of a written notice on March 27, 2026. |
| · | March 2026: Appointed Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to the Board of Directors. |
| · | March 2026: Announced grant of a key European patent from the European Patent Office (EPO) directed to label-relevant dosing regimens of vidofludimus calcium. The patent is expected to provide protection into 2038 and may be eligible for a Supplementary Protection Certificate (SPC), which could extend market exclusivity potentially into 2043. This patent was previously granted by the United States Patent and Trademark Office (USPTO) in 2023. |
| · | February 2026: Completed an oversubscribed private placement financing of up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received upon closing on February 17, 2026. |
| o | Elevated Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Appointed Thor Nagel, Principal at BVF Partners L.P., to the Board. Plans underway for further Board refreshment to support the company’s evolution into a commercial-stage organization. |
| o | Initiated search for a new Chief Executive Officer with deep commercial expertise in neurology to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his roots and transition to a new senior executive role focused on scientific strategy and portfolio advancement, while remaining on the Board. |
| · | February 2026: Presented additional data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the ACTRIMS Forum 2026 in San Diego, California. The findings, presented in two poster presentations, 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 Immunic’s belief that vidofludimus calcium has the potential to address underlying 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. 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 is estimated to take approximately 3.5 to 4 years to complete. |
| · | IMU-856: The company is currently exploring strategic alternatives for the IMU-856 program and is open to discussing potential financing, licensing or partnering options with interested parties. |
Financial and Operating Results
| · | Research and Development (R&D) Expenses were $25.6 million for the three months ended March 31, 2026, as compared to $21.5 million for the three months ended March 31, 2025. The $4.1 million increase reflects (i) a $2.9 million increase in external development costs related to the vidofludimus calcium program, (ii) a $1.0 million increase in personnel expenses, $0.7 million of which was related to non-cash stock compensation and (iii) a $0.2 million increase related to costs across numerous categories. |
| · | General and Administrative (G&A) Expenses were $7.6 million for the three months ended March 31, 2026, as compared to $5.3 million for the same period ended March 31, 2025. The $2.3 million increase was due to (i) a $2.0 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation, (ii) a $0.2 million increase in legal and consultancy expenses, (iii) a $0.2 million increase in marketing expenses, which was partially offset by a $0.1 million decrease related to costs across numerous categories. |
| · | Interest Income was $0.8 million for the three months ended March 31, 2026, as compared to $0.2 million for the three months ended March 31, 2025. The $0.6 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement. |
| · | Other Income (Expense) was ($0.1) million for the three months ended March 31, 2026, as compared to $1.2 million for the same period ended March 31, 2025. The $1.3 million decrease was primarily attributable to (i) a $1.1 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and no grant income in 2026 and (ii) a $0.2 million decrease across numerous categories. |
| · | Net Loss for the three months ended March 31, 2026, was approximately $32.6 million, or $1.08 per basic and diluted share, based on 30,136,324 weighted average common shares outstanding, compared to a net loss of approximately $25.5 million, or $2.51 per basic and diluted share, based on 10,134,443 weighted average common shares outstanding for the same period ended March 31, 2025. |
| · | Cash and Cash Equivalents as of March 31, 2026 were $186.6 million. With these funds, Immunic expects to be able 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 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 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; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure 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.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 25,626 | $ | 21,533 | ||||
| General and administrative | 7,609 | 5,292 | ||||||
| Total operating expenses | 33,235 | 26,825 | ||||||
| Loss from operations | (33,235 | ) | (26,825 | ) | ||||
| Other income: | ||||||||
| Interest income | 760 | 183 | ||||||
| Other income (expense), net | (113 | ) | 1,169 | |||||
| Total other income | 647 | 1,352 | ||||||
| Net loss | $ | (32,588 | ) | $ | (25,473 | ) | ||
| Net loss per share, basic and diluted | $ | (1.08 | ) | $ | (2.51 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 30,136,324 | 10,134,443 | ||||||
Immunic, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| March 31, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 186,629 | $ | 15,483 | ||||
| Prepaid expenses and other current assets | 2,130 | 7,386 | ||||||
| Total current assets | 188,759 | 22,869 | ||||||
| Property and equipment, net | 566 | 608 | ||||||
| Right-of-use assets, net | 417 | 575 | ||||||
| Total assets | $ | 189,742 | $ | 24,052 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,011 | $ | 10,138 | ||||
| Accrued expenses | 22,432 | 18,645 | ||||||
| Other current liabilities | 4,920 | 1,835 | ||||||
| Total current liabilities | 38,363 | 30,618 | ||||||
| Long-term liabilities | ||||||||
| Operating lease liabilities | 146 | 107 | ||||||
| Total long-term liabilities | 146 | 107 | ||||||
| Total liabilities | 38,509 | 30,725 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding as of March 31, 2026 and December 31, 2025 | — | — | ||||||
| Common stock, $0.0001 par value; 500,000,000 shares authorized as of March 31, 2026 and December 31, 2025 and 13,621,483 and 12,038,263 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively. | 11 | 9 | ||||||
| Additional paid-in capital | 789,324 | 599,241 | ||||||
| Accumulated other comprehensive income | 3,057 | 2,648 | ||||||
| Accumulated deficit | (641,159 | ) | (608,571 | ) | ||||
| Total stockholders’ equity (deficit) | 151,233 | (6,673 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 189,742 | $ | 24,052 | ||||