Immunic, Inc. Reports Year-End 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Immunic (Nasdaq: IMUX) reported year-end 2025 results and a corporate update. Key developments include a completed oversubscribed private placement providing $200 million upfront (up to $400 million total), top-line Phase 3 ENSURE RMS data expected by year-end 2026, and plans for an NDA submission in mid-2027 with a targeted approval in 2028.
The company disclosed a net loss of $97.2 million for 2025, R&D expense of $82.0 million, and cash & equivalents of $15.5 million as of Dec 31, 2025. Combined with ~$187.0 million net proceeds from the February 2026 financing, management expects funding into late 2027. Immunic plans a Phase 3 PPMS program and commercial buildout pending trial outcomes.
Positive
- Upfront private placement proceeds of $200 million
- Top-line Phase 3 ENSURE RMS data expected by year-end 2026
- Planned U.S. NDA submission in mid-2027 with targeted approval in 2028
- Planned initiation of Phase 3 PPMS program later in 2026
Negative
- Net loss of $97.2 million for 2025
- Cash and equivalents of $15.5 million at Dec 31, 2025; runway into late 2027 only with financing proceeds
News Market Reaction – IMUX
On the day this news was published, IMUX gained 4.10%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
IMUX was up 1.35% while peers were mixed: ATRA up 20.76%, CRVO down 8.35%, IRD down 5.15%, ABOS and IGMS modestly negative. This points to stock-specific dynamics rather than a sector-wide move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 13 | Q3 2025 earnings | Negative | -6.2% | Reported Q3 loss, highlighted insufficient liquidity despite clinical progress. |
| Aug 07 | Q2 2025 earnings | Negative | -7.9% | Q2 loss and statement that cash was insufficient for 12 months. |
| Nov 07 | Q3 2024 earnings | Neutral | +0.0% | Q3 loss but positive ENSURE interim and cash runway into Q3 2025. |
| Aug 08 | Q2 2024 earnings | Positive | +14.5% | Improved expense profile, strong MS progress and solid cash runway. |
| May 08 | Q1 2024 earnings | Positive | -8.0% | Financing and pipeline progress but shares fell despite supportive news. |
Earnings updates often saw modestly negative average moves, with several selloffs on otherwise constructive clinical and financial progress.
Over the last two years, Immunic’s earnings reports have consistently combined clinical progress in multiple sclerosis with significant cash burn and funding needs. Events on May 8, 2024 and August 7, 2025 highlighted financing transactions and promising vidofludimus calcium data, yet shares often traded down after results. The November 13, 2025 update again emphasized net losses and limited liquidity. Against this backdrop, the current annual results pair similar R&D spend and net loss figures with a fully funded plan into late 2027, marking an evolution from prior liquidity constraints.
Historical Comparison
Past earnings headlines led to an average move of -1.51%. Today’s +1.35% pre-news gain is modestly better than typical earnings-day pressure.
Earnings releases have evolved from highlighting liquidity shortfalls and reliance on future financings to today’s update, which pairs similar R&D spending and net loss levels with recently secured capital intended to fund operations into late 2027.
Market Pulse Summary
This announcement combines year-end 2025 financials with a clear funding and development path. Immunic reported a $97.2M net loss on R&D of $82.0M and G&A of $21.2M, but cash was supplemented by about $187.0M net from a February 2026 private placement, targeting operations into late 2027. Key watchpoints include execution of Phase 3 ENSURE and PPMS programs, timing of the planned NDA submission, and how expense levels evolve as the company builds commercial infrastructure.
Key Terms
new drug application (nda) regulatory
nurr1 medical
dhodh inhibition medical
ebv medical
mri medical
AI-generated analysis. Not financial advice.
– Top-Line Data from Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 –
– Raised Proceeds of
– Net Proceeds Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive Multiple Sclerosis and Begin of Transition into a Commercial Organization –
"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
"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
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
Fourth Quarter 2025 and Subsequent Highlights
- February 2026: Completed an oversubscribed private placement of up to
$400 million $200 million - Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, elevated to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Thor Nagel, Principal at BVF Partners L.P., appointed to the Board. Plans underway for further Board refreshment to support the company's evolution into a commercial-stage organization.
- Initiated search for a new Chief Executive Officer with deep commercial expertise in MS 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 progressive MS at the ACTRIMS Forum 2026. 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:
- 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. - Initiation of a phase 3 clinical program in PPMS is expected later this year and estimated to take approximately 3.5 to 4 years to complete.
- 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
- IMU-856: The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$82.0 million $80.0 million $1.9 million $3.9 million $1.8 million $3.0 million $0.8 million - General and Administrative (G&A) Expenses were
$21.2 million $18.0 million $3.2 million $1.9 million $0.3 million $0.8 million $0.5 million - Interest Income was
$1.0 million $3.4 million $2.4 million - In the twelve months ended December 31, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the company's authorized shares from 130 million to 500 million shares of common stock and, therefore, the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the twelve months ended December 31, 2025.
- Other Income (Expense) was
$5.0 million $1.0 million $6.1 million $4.8 million $1.0 million $3.8 million $1.7 million $0.3 million $0.7 million Australia due to lower clinical trial spend inAustralia . - Net Loss for the twelve months ended December 31, 2025, was approximately
$97.2 million $0.62 $100.5 million $1.00 - Cash and Cash Equivalents as of December 31, 2025 were approximately
$15.5 million $187.0 million
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.
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; 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
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) | |||
December 31, | |||
2025 | 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, | — | — | |
Common stock, | 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 | |
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SOURCE Immunic, Inc.
FAQ
When will Immunic (IMUX) report top-line results from the Phase 3 ENSURE RMS trials?
How much did Immunic (IMUX) raise in its February 2026 private placement and how will proceeds be used?
What is Immunic's (IMUX) cash runway after the 2026 financing?
What were Immunic's (IMUX) 2025 R&D expense and net loss figures?
Will Immunic (IMUX) start a Phase 3 program in primary progressive MS (PPMS) in 2026?
