Immunic, Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Immunic (Nasdaq: IMUX) reported a third-quarter 2026 net loss of approximately $42.3 million while advancing its multiple sclerosis clinical programs. Loss per basic and diluted share was $0.99, versus $1.32 a year earlier, as weighted-average shares increased. The prior-year quarterly net loss was approximately $25.6 million. Research and development expenses rose to $23.9 million from $20.0 million; general and administrative expenses increased to $19.4 million from $6.0 million.
Immunic expects December 2026 results from its fully enrolled Phase 3 ENSURE trials of vidofludimus calcium. Positive results would support a planned U.S. approval application in mid-2027, targeting potential approval in 2028. First enrollment in the Phase 3 PROTECT-MS trial is expected in the first half of 2027. Cash and cash equivalents totaled $132.0 million at September 30, which the company expects to fund operations into late 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Fully enrolled ENSURE-1 and ENSURE-2 trials remain on track for expected December 2026 results.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunic plans a mid-2027 U.S. approval application if ENSURE results are positive, targeting potential approval in 2028.
- Moderate point. Forward-looking: it has not happened yet and may not happen.PROTECT-MS initiation is ongoing; Immunic expects first enrollment in the first half of 2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.$132.0 million in September 30 cash and equivalents is expected to fund operations into late 2027.
- Minor pointCALLIPER extension analyses suggested favorable disability trends persisted among participants continuing vidofludimus calcium.
7 minor points
- Minor pointCALLIPER extension discontinuation was 6.5% through January 27, 2026; safety appeared consistent with the double-blind period.
- Minor pointExploratory CALLIPER analysis found reduced EBV-specific T-cell receptor sequence matches versus placebo.
- Minor pointPost-hoc CALLIPER analysis associated reduced EBV-specific matches with improved cognitive test scores across all patients.
- Minor pointPost-hoc CALLIPER analysis using proposed methods suggested more favorable disability outcomes with vidofludimus calcium versus placebo.
- Minor pointPreclinical findings suggested Nurr1-dependent neuronal survival under cell-death stress; this effect was not observed with teriflunomide.
- Minor pointQuarterly interest income rose to $1.1 million from $0.4 million year over year.
- Minor pointNine-month interest income rose to $3.1 million from $0.8 million year over year.
Negative
- Major pointThird-quarter net loss widened to approximately $42.3 million from approximately $25.6 million year over year.
- Moderate pointQuarterly R&D expenses increased to $23.9 million from $20.0 million year over year.
- Moderate pointQuarterly G&A expenses rose to $19.4 million from $6.0 million, including separation-related stock compensation.
- Moderate pointQuarterly weighted-average common shares increased to 42,797,370 from 19,389,776 year over year.
- Minor pointNine-month net loss widened to approximately $109.0 million from approximately $77.9 million year over year.
9 minor points
- Minor pointNine-month R&D expenses increased to $75.5 million from $62.9 million year over year.
- Minor pointNine-month G&A expenses rose to $36.4 million from $17.0 million, including separation-related stock compensation.
- Minor pointNine-month weighted-average common shares increased to 38,508,964 from 14,281,149 year over year.
- Minor pointQuarterly other expense increased to $0.03 million from $0.01 million year over year.
- Minor pointNine-month other results shifted to $0.2 million expense from $1.2 million income a year earlier.
- Minor point. Forward-looking: it has not happened yet and may not happen.Planned U.S. approval application depends on positive ENSURE results.
- Minor pointCALLIPER extension findings lack placebo control and include only participants electing to continue treatment.
- Minor pointProposed disability-analysis methods are not validated or accepted by regulatory authorities.
- Minor pointPreclinical neuronal-survival findings have no established clinical relevance.
News Explained
In its third-quarter report, Immunic reported 15,880,822 common shares outstanding on
Key Figures
- ENSURE-1 enrollment
- 1,121 patients
- Phase 3 relapsing MS trial
- ENSURE-2 enrollment
- 1,100 patients
- Phase 3 relapsing MS trial
- Top-line data
- Expected in December 2026
- ENSURE-1 and ENSURE-2; remains on track
- U.S. NDA submission
- Planned for mid-2027
- Conditional on positive ENSURE results
- Potential approval target
- 2028
- Targeted timing, conditional on positive ENSURE results
- Third-quarter net loss
- Approximately $42.3 million; $0.99 per share
- Three months ended September 30, 2026
- Cash and cash equivalents
- $132.0 million
- As of September 30, 2026
- Expected cash runway
- Into late 2027
- Based on the company's current operating plan
Previous Earnings Reports
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Private placement delivered $200 million upfront and cash runway was projected into late 2027.
-
ENSURE trials remained on track and management maintained its late-2027 funding outlook.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
nda regulatory
ole medical
post-hoc analysis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Pivotal Phase 3 ENSURE-1 and ENSURE-2 Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Remain on Track, with Top-Line Data Expected in December 2026 –
– Initiation of Phase 3 PROTECT-MS Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Ongoing, with First-Patient-Enrolled Expected in the First Half of 2027 –
– Executive Leadership Team Further Strengthened with Appointments of Chief Data and Digital Officer and Chief People Officer to Support Regulatory and Commercial Readiness –
"As we approach the top-line data from our Phase 3 ENSURE trials in relapsing multiple sclerosis (MS) in December, we believe Immunic is entering one of the most important periods in its history," said Erik Lundgren, Chief Executive Officer of Immunic. "We are evolving from a science-driven biotechnology company into a fully integrated commercial organization, with a key focus on understanding and addressing the needs of people living with MS. We believe vidofludimus calcium has the potential to address mechanisms associated with both the neurodegenerative and inflammatory drivers of the disease, which, if confirmed in our Phase 3 trials, could offer a differentiated treatment option in MS. Subject to positive ENSURE results, we are preparing for a potential New Drug Application (NDA) submission in relapsing MS, while we continue to advance our Phase 3 program in progressive MS."
"We were fortunate to present exciting data in four posters at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting, which added complementary clinical and mechanistic evidence supporting the potential of vidofludimus calcium to address existing unmet needs in MS," added Michael A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. "Further, our Phase 3 ENSURE trials in relapsing MS continue to be on track to report top-line data in December 2026. Our teams remain focused on this readout and readiness for a potential NDA submission should the results be positive. In parallel, the Phase 2 CALLIPER data along with the insights shared by leading MS experts at our two recent R&D Days support the rational for our Phase 3 PROTECT-MS trial in progressive MS, with initiation ongoing and first-patient-enrolled expected in the first half of 2027."
Third Quarter 2026 and Subsequent Highlights
- Ongoing Phase 3 ENSURE Relapsing MS Program: Continued to execute the fully enrolled twin Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing MS, which randomized 1,121 and 1,100 patients, respectively, at more than 100 sites in 15 countries.
- Preparation of Phase 3 Progressive MS Program: Continued initiation activities for the Phase 3 PROTECT-MS trial in progressive MS, informed by the Phase 2 CALLIPER trial data.
- Hosted Virtual Progressive MS R&D Day: On November 5, 2026, hosted a virtual R&D day focused on progressive MS. Jiwon Oh, M.D., Ph.D., FRCPC, Division of Neurology, University of
Toronto , and Maria Pia Sormani, Ph.D., University ofGenoa , Italy, joined Immunic's management team to discuss the key unmet needs in progressive MS and the persistent needs for innovative approaches to the development of therapies that target novel mechanisms associated with neurodegeneration and MS progression. The event highlighted the potential expansion opportunity for vidofludimus calcium in progressive MS, including the clinical and scientific rationale supporting Immunic's plans to initiate a Phase 3 progressive MS trial. A replay is available on the "Events and Presentations" section of Immunic's website. - New Data Presented at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting: Presented new clinical, biomarker and preclinical data for vidofludimus calcium across four poster presentations at MSToronto2026, held October 21-23, 2026, in
Toronto . Highlights included:- New analyses of the Phase 2 CALLIPER trial in progressive MS showed that the favorable trends on disability outcomes observed during the double-blind main treatment period appeared to be maintained during the open-label extension (OLE) phase among participants who continued vidofludimus calcium treatment. Because the OLE phase is not placebo-controlled and includes only participants who elected to continue treatment, these results should be interpreted with caution. Only
6.5% of patients discontinued through the January 27, 2026 data cutoff, with a safety and tolerability profile that appeared consistent with that observed in the double-blind period. - New preclinical findings suggest that vidofludimus calcium promoted neuronal survival under apoptotic stress conditions, an effect requiring Nurr1. Under these in vitro experimental conditions, this Nurr-1 dependent pro-survival effect was not observed with teriflunomide, providing preclinical evidence suggesting that it involves mechanisms beyond DHODH inhibition. The clinical relevance of these findings has not been established.
- An exploratory CALLIPER analysis found that vidofludimus calcium reduced Epstein-Barr virus (EBV)-specific T-cell receptor sequence matches versus placebo-treated patients, and, in a post-hoc analysis across all patients, reductions in EBV-specific matches were associated with improved Symbol Digit Modalities Test (SDMT) scores.
- In a post-hoc analysis applying two proposed novel statistical methods that integrate disability worsening and improvement into a single statistical measure, progressive MS patients in CALLIPER treated with vidofludimus calcium appeared more likely to have positive disability outcomes compared to placebo. These methods have not been validated or accepted by regulatory authorities.
- New analyses of the Phase 2 CALLIPER trial in progressive MS showed that the favorable trends on disability outcomes observed during the double-blind main treatment period appeared to be maintained during the open-label extension (OLE) phase among participants who continued vidofludimus calcium treatment. Because the OLE phase is not placebo-controlled and includes only participants who elected to continue treatment, these results should be interpreted with caution. Only
- Hosted Virtual Relapsing MS R&D Day: On September 9, 2026, hosted a virtual R&D day focused on relapsing MS, at which management discussed the potential of vidofludimus calcium to address mechanisms associated with both neurodegenerative and inflammatory drivers of MS and shared insights into how its differentiated approach could add to the evolving treatment landscape in relapsing MS. MS experts Amit Bar-Or, M.D., FRCPC, Perelman School of Medicine, University of
Pennsylvania , and Stephen Krieger, M.D., FAAN, Icahn School of Medicine, The Mount Sinai Hospital, provided expert perspectives on the MS patient journey, current treatment paradigms and unmet medical needs. A replay is available on the "Events and Presentations" section of Immunic's website. - Expansion of Executive Leadership Team and Board of Directors:
- Appointed Jaa Roberson as Chief People Officer, effective October 19, 2026. In this newly created executive role, Ms. Roberson leads Immunic's global talent and organizational strategy as the company prepares for the ENSURE read-out and potential commercialization. Ms. Roberson brings more than two decades of human resources experience, most recently as Chief People Officer at Day One Biopharmaceuticals, and earlier, at Genentech supporting commercial franchises, including Ocrevus® for MS.
- Appointed Chitrang Davé, M.B.A., as Chief Data and Digital Officer, effective September 1, 2026. In this newly created C-suite role, Mr. Davé leads Immunic's enterprise-wide data, analytics, AI and digital strategy in support of NDA and commercial readiness. Mr. Davé brings more than 25 years of data and analytics leadership experience across regulated life sciences environments, most recently as Head of Enterprise Data, AI & Advanced Analytics at Avidity Biosciences, and previously in senior roles at Edwards Lifesciences and Medtronic.
- Appointed Elena Ridloff, CFA, to the Board of Directors, effective August 6, 2026. Ms. Ridloff brings more than 20 years of leadership experience in finance, corporate development, investor relations, and capital markets across the biopharmaceutical industry. She currently serves as Chief Financial Officer and Chief Business Officer at Sionna Therapeutics.
Anticipated Clinical Milestones
- Vidofludimus Calcium in Relapsing MS: Top-line data from the twin Phase 3 ENSURE-1 and ENSURE-2 trials remains on track and is expected to be available in December 2026. If positive, Immunic plans to submit an NDA in
the United States in mid-2027, with a targeted potential regulatory approval date in 2028. - Vidofludimus Calcium in Progressive MS: The initiation of the Phase 3 PROTECT-MS trial in progressive MS is ongoing, with first-patient-enrolled expected in the first half of 2027.
- IMU-381: The IMU-381 program, selected to leverage the Nurr1 platform for neurologic and autoimmune diseases, continues to be in preclinical testing with lead candidate identification ongoing.
Financial and Operating Results
Total Operating Expenses for the three and nine months ended September 30, 2026 were
Research and Development (R&D) Expenses were
For the nine months ended September 30, 2026, R&D expenses were
General and Administrative (G&A) Expenses were
For the nine months ended September 30, 2026, G&A expenses were
Interest Income was
For the nine months ended September 30, 2026, interest income was
Other Income (Expense) was (
For the nine months ended September 30, 2026, Other Income (Expense) was (
Net Loss for the three months ended September 30, 2026, was approximately
Net loss for the nine months ended September 30, 2026, was approximately
Cash and Cash Equivalents as of September 30, 2026 were
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 investigational asset, vidofludimus calcium (IMU-838), is currently being evaluated in Phase 3 clinical trials in relapsing multiple sclerosis, with top-line data expected to be available in December 2026. Initiation of an additional Phase 3 clinical trial in progressive multiple sclerosis is ongoing, with first-patient-enrolled expected in the first half of 2027. Vidofludimus calcium combines potential neuroprotective effects associated with nuclear receptor-related 1 (Nurr1) activation with anti-inflammatory and anti-viral effects associated with selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune diseases. For further information, please visit: www.imux.com.
Vidofludimus calcium (IMU-838) is an investigational medicinal product that has not been approved or authorized by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other regulatory authority for any indication in any jurisdiction. Its safety and efficacy have not been established. Any clinical, biomarker, or preclinical findings described reflect investigational data and are not intended to suggest that vidofludimus calcium is safe or effective for any use.
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 the nature, strategy and focus of the company; the development and commercial potential of Immunic's product candidates, including their potential to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the expected timing and results of the Phase 3 ENSURE trials; the timing of a Phase 3 trial of vidofludimus calcium in progressive multiple sclerosis; the timing of potential NDA submission and regulatory approval; expectations regarding the capitalization, resources and ownership structure of the company; the expected sufficiency of Immunic's cash and cash equivalents; 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, the risk that top-line results from the ENSURE-1 and ENSURE-2 trials may be delayed, negative, or fail to meet their primary or secondary endpoints; the risk that results of earlier, post-hoc, exploratory, open-label or preclinical analyses may not be predictive of, or confirmed in, subsequent controlled clinical trials or accepted by regulatory authorities; the risk that the initiation, or first-patient enrollment in, of the Phase 3 progressive MS trial, or the submission or approval of an NDA, may be delayed or may not occur; risks related to drug development and the regulatory review process; the risk that Immunic's cash and cash equivalents may be insufficient to fund operations for the period anticipated, including due to changes to its operating plan, and Immunic's need to raise additional capital; increasing inflation, tariffs and macroeconomic trends; impacts of the Ukraine – Russia conflict and the conflict in the Middle East on clinical trials; changes to the size of the target markets for the company's product candidates; the protection and market exclusivity provided by Immunic's intellectual property; 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, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026. 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
LifeSci Advisors
Joyce Allaire
immunic@lifesciadvisors.com
US Media Contact
Real Chemistry
media@imux.com
Financials
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Immunic, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) |
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September 30, 2026 |
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December 31, 2025 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ 131,963 |
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$ 15,483 |
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Other current assets and prepaid expenses |
3,124 |
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7,386 |
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Total current assets |
135,087 |
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22,869 |
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Property and equipment, net |
832 |
|
608 |
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Right-of-use assets, net |
504 |
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575 |
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Total assets |
$ 136,423 |
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$ 24,052 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
$ 10,120 |
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$ 10,138 |
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Accrued expenses |
20,058 |
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18,645 |
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Other current liabilities |
1,372 |
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1,835 |
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Total current liabilities |
31,550 |
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30,618 |
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Long-term liabilities |
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Other long term liabilities |
400 |
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107 |
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Total long-term liabilities |
400 |
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107 |
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Total liabilities |
31,950 |
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30,725 |
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Commitments and contingencies |
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Stockholders' equity: |
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Preferred stock, or outstanding as of September 30, 2026 and December 31, 2025 |
— |
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— |
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Common stock, 2026 and December 31, 2025, and 15,880,822 and 12,038,263 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively |
1 |
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1 |
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Additional paid-in capital |
819,290 |
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599,249 |
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Accumulated other comprehensive income |
2,749 |
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2,648 |
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Accumulated deficit |
(717,567) |
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(608,571) |
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Total stockholders' equity |
104,473 |
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(6,673) |
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Total liabilities and stockholders' equity |
$ 136,423 |
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$ 24,052 |
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Immunic, Inc. Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ 23,948 |
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$ 20,012 |
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$ 75,505 |
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$ 62,914 |
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General and administrative |
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19,421 |
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5,981 |
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36,426 |
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16,987 |
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Total operating expenses |
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43,369 |
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25,993 |
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111,931 |
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79,901 |
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Loss from operations |
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(43,369) |
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(25,993) |
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(111,931) |
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(79,901) |
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Other income (expense): |
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|
|
|
|
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Interest income |
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1,093 |
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419 |
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3,139 |
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843 |
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Other income (expense), net |
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(33) |
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(5) |
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(204) |
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1,186 |
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Total other income |
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1,060 |
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414 |
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2,935 |
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2,029 |
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Net loss |
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$ (42,309) |
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$ (25,579) |
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$ (77,872) |
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Net loss per share, basic and diluted |
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$ (0.99) |
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$ (1.32) |
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$ (2.83) |
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$ (5.45) |
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Weighted-average common shares outstanding, basic and diluted |
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42,797,370 |
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19,389,776 |
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38,508,964 |
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14,281,149 |
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SOURCE Immunic, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When will Immunic report Phase 3 ENSURE results for vidofludimus calcium?
Immunic expects top-line results from ENSURE-1 and ENSURE-2 in December 2026. The fully enrolled relapsing multiple sclerosis trials randomized 1,121 and 1,100 patients, respectively. If results are positive, the company plans a U.S. approval application in mid-2027, targeting potential regulatory approval in 2028.
How long does Immunic expect its September 2026 cash balance to last?
Immunic expects its $132.0 million of cash and cash equivalents at September 30, 2026 to fund operations into late 2027, based on its current operating plan.
What limits the interpretation of Immunic's CALLIPER extension findings?
The CALLIPER open-label extension has no placebo control and includes only participants who elected to continue treatment. Favorable disability trends appeared to persist among participants continuing vidofludimus calcium, but those design limitations require caution when interpreting the findings.
What is the status of Immunic's IMU-381 program?
IMU-381 remains in preclinical testing, with lead candidate identification ongoing. The program was selected to leverage the Nurr1 platform for neurologic and autoimmune diseases.