Immunic (IMUX) posts larger Q2 2026 loss but extends cash runway into 2027
Rhea-AI Filing Summary
Immunic, Inc. reported second quarter 2026 results, board changes and leadership transitions while advancing its multiple sclerosis pipeline. For the quarter ended June 30, 2026, total operating expenses were $35.3 million, driven by research and development of $25.9 million and general and administrative costs of $9.4 million, both higher than the prior-year period due largely to increased personnel and non-cash stock compensation and NDA-supporting studies. Net loss was $34.1 million (basic and diluted loss of $0.80 per share).
Cash and cash equivalents were $155.1 million as of June 30, 2026, and the company expects this to fund operations into late 2027. Clinically, Phase 3 ENSURE trials of vidofludimus calcium in relapsing MS remain on track with top-line data expected by the end of 2026, and a Phase 3 trial in progressive MS is planned to start later in 2026. Governance updates include the appointment of Elena Ridloff to the board, with an inaugural option grant for 50,740 shares, and the resignation and separation of former CEO Dr. Daniel Vitt, who moves to a consulting role and Chair of the Scientific Advisory Board under a detailed severance and consulting arrangement.
Positive
- Cash of $155.1 million at June 30, 2026, with stated ability to fund operations into late 2027, provides visibility to reach key Phase 3 data and potential regulatory milestones.
- Lead asset vidofludimus calcium is in Phase 3 ENSURE trials for relapsing MS with top-line data expected by end of 2026 and a progressive MS Phase 3 trial planned later in 2026, indicating an advanced, potentially registration-enabling program.
- Leadership and governance have been strengthened with the appointment of Elena Ridloff, an experienced biotech CFO and capital markets executive, to the board as the company prepares for potential NDA and commercialization.
- Management highlights additional supportive Phase 2 CALLIPER data in progressive MS and notes regulatory alignment on the time-to-first-relapse primary endpoint, clarifying the potential path to regulatory submission upon positive results.
Negative
- Quarterly net loss increased to $34.1 million from $26.8 million year over year, reflecting higher R&D and G&A expenses tied to late-stage development and organizational build-out.
- Operating expenses rose significantly, with R&D at $25.9 million and G&A at $9.4 million in Q2 2026, driven by personnel, non-cash stock compensation, legal, and pre-commercial marketing costs.
- The separation of former CEO Dr. Daniel Vitt entails notable cash commitments, including a $670,000 lump-sum portion of salary-related severance, a $276,375 bonus payment, up to €15,000 per month consulting fees, and additional healthcare and legal reimbursements.
Filing Explained
The August 6 board appointment is effective; the August 7 separation creates disclosed cash, consulting, healthcare, legal-fee and accelerated-equity obligations.
This Form 8-K reports that Elena Ridloff joined Immunic’s board effective
The director award is an option to purchase up to 50,740 shares, with an exercise price equal to the August 6 closing price and monthly vesting over three years; the filing does not report those shares as issued.
Subject to a timely release of claims, the separation agreement provides Mr. Vitt with
The specified timing hinges on the release effective date: the initial severance and bonus are payable after that date, while the remaining salary installments begin after its one-year anniversary. The consulting period is initially 12 months at
8-K Event Classification
Key Figures
Key Terms
oversubscribed private placement financing financial
non-cash stock compensation financial
Phase 3 ENSURE trials medical
dihydroorotate dehydrogenase (DHODH) medical
Separation Agreement regulatory
Earnings Snapshot
The company expects its cash and cash equivalents as of June 30, 2026, to fund operations into late 2027 and anticipates top-line Phase 3 ENSURE data in relapsing MS by the end of 2026, with initiation of a progressive MS Phase 3 trial later in 2026.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
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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 |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐
Item 2.02. Results of Operations and Financial Condition
On August 11, 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 June 30, 2026, and providing a corporate update (the “Earnings Release”).
The information contained in Item 2.02 of this Current Report on Form 8-K, including the Earnings Release, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). In addition, this information shall not be deemed incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission (the “Commission”), except as shall be expressly set forth by specific reference in any such filing.
Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
Appointment of Director
On August 6, 2026, the board of directors (the “Board”) of the Company appointed Elena Ridloff as a member of the Board, effective immediately. As a Class I director, Ms. Ridloff’s term lasts until the Company’s 2027 annual meeting of stockholders, and until her successor is duly elected and qualified, or until her earlier death, resignation or removal.
Elena Ridloff, CFA, age 46, has served as a member of the board of directors of Kymera Therapeutics, Inc. since March 2021. Ms. Ridloff has served as the Chief Financial Officer of Sionna Therapeutics, Inc., a publicly traded life sciences company, since September 2021. Ms. Ridloff previously served as the Executive Vice President and Chief Financial Officer of ACADIA Pharmaceuticals Inc., or ACADIA, a publicly traded pharmaceutical company. Ms. Ridloff joined ACADIA in April 2018 as Senior Vice President, Investor Relations, where she led investor and financial communications activities, and served as ACADIA’s Chief Financial Officer from October 2018 to September 2021. Before ACADIA, Ms. Ridloff held various roles at Alexion Pharmaceuticals, Inc., or Alexion, including Executive Director, Investor Relations from April 2014 to January 2016, and Vice President, Investor Relations from January 2016 to March 2018. Prior to joining Alexion, Ms. Ridloff served as the Chief Executive Officer and Managing Member of BIOVISIO, an independent consulting firm providing strategic, financial and investor relations counsel to the life sciences industry, from January 2012 to April 2014. Ms. Ridloff also spent over a decade as an institutional investor and from July 2005 to January 2012 served as Managing Director at Maverick Capital, a hedge fund, where she was responsible for investments in the biotechnology, pharmaceutical, medical device and life science sectors. From September 2020 until its acquisition by Concentra Biosciences, LLC in June 2025, Ms. Ridloff served on the board of directors of Kronos Bio, Inc. Ms. Ridloff earned her B.A. in history and sociology of science from the University of Pennsylvania and is a Chartered Financial Analyst. We believe Ms. Ridloff is qualified to serve on our board of directors due to her financial and accounting expertise and her experience in the finance and life sciences industries.
In connection with her appointment as a director, Ms. Ridloff received an inaugural grant of options to purchase up to a total of 50,740 shares of the Company’s common stock, effective August 6, 2026, which vest on a monthly basis over a three year period. The foregoing options have an exercise price per share equal to the closing price of the Company’s common stock on The Nasdaq Stock Market on August 6, 2026 (the “Award”). Ms. Ridloff will also receive cash compensation for her service on the Board in accordance with the Company’s non-employee director compensation policy, as described in the Company’s most recent proxy statement, as may be adjusted from time to time as set forth in the Company’s filings and reports made with the Securities and Exchange Commission.
There is no relationship or agreement between Ms. Ridloff and any other person pursuant to which she was appointed as a director of the Company and there is no family relationship between Ms. Ridloff and any of the Company’s directors or executive officers. The Company is not aware of any transaction involving Ms. Ridloff which would require disclosure under Item 404(a) of Regulation S-K promulgated under the Securities Act, other than as set forth in this Current Report on Form 8-K.
Ms. Ridloff and the Company will enter into a customary indemnity agreement, substantially in the form filed as Exhibit 10.7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Commission on February 26, 2026.
Resignation of Dr. Daniel Vitt
On August 6, 2026, Daniel Vitt, resigned as a member of the Board. The resignation of Dr. Vitt was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices. The Board is deeply grateful for Dr. Vitt’s service, dedication, and contributions to the Company.
As previously disclosed, on May 22, 2026, Daniel Vitt, resigned as the Chief Executive Officer of the Company, effective June 1, 2026. Since June 1, 2026, Dr. Vitt continued to retain responsibility for scientific strategy and portfolio advancement and there were no changes to the Company’s compensation arrangements with Dr. Vitt.
On August 7, 2026, the Company entered into a Separation Agreement (the “Separation Agreement”) with Dr. Vitt, pursuant to which Dr. Vitt’s employment with the Company terminated on such date (the “Separation Date”). Pursuant to the Separation Agreement, Dr. Vitt agreed to serve as Chair of the Company’s Scientific Advisory Board (the “SAB”).
In addition, Dr. Vitt entered into an agreement with Immunic AG, a wholly owned subsidiary of the Company (the “Company Subsidiary”), pursuant to which he ceased to be a member of the Executive Board of the Company Subsidiary as of the Separation Date, and his service agreement with the Company Subsidiary, dated December 18, 2023 (the “Service Agreement”), terminated without any ongoing obligations. From the date of the Separation Agreement through the Separation Date, (a) the Company agreed to pay Dr. Vitt all accrued salary earned through the Separation Date, subject to standard payroll deductions and withholdings, and (b) the Company Subsidiary agreed to pay Dr. Vitt all accrued salary earned under the Service Agreement through the Separation Date, subject to standard payroll deductions and withholdings, and the Company and the Company Subsidiary agreed to pay Dr. Vitt for all accrued and unused vacation days on the Company’s first regular payroll payday following the Separation Date.
Commencing on the Separation Date, Dr. Vitt began serving as a consultant to the Company Subsidiary for an initial period of twelve
(12) months (the “Consulting Period”), in addition to serving as Chair of the SAB, providing consulting services on an as-needed basis for up to fifteen (15) hours per month, in exchange for a monthly retainer of €15,000. Dr. Vitt also agreed to non-competition and non- solicitation covenants through the Consulting Period and for six (6) months following the date he ceases to be a member of the SAB. In addition, the Company and the Company Subsidiary agreed to provide Dr. Vitt with severance benefits, subject to his timely execution and non-revocation of a release of claims in favor of the Company, including (i) a salary payment consisting of his base salary and the monthly installment of his fixed annual salary under the Service Agreement, in each case for a period of sixteen and one-half (16.5) months following the Separation Date, of which the first twelve (12) installments (equal to $670,000 in the aggregate) will be paid in a lump sum on the first regular payroll payday following the Release Effective Date (as defined in the Separation Agreement) and the remaining four and one-half (4.5) months will be paid in five (5) monthly installments (the last at half pay) beginning on the first regular payroll payday following the one-year anniversary of the Release Effective Date, (ii) an aggregate bonus payment of $276,375 (or the Euro equivalent), equal to seventy-five percent (75%) of his target bonus for fiscal year 2026, payable in a lump sum on or before the Company’s first regular payroll payday following the Release Effective Date, and (iii) reimbursement from the Company Subsidiary for the monthly cost of obtaining healthcare in Germany, in an amount not to exceed €1,500 per month, for a period of eighteen (18) months following the Release Effective Date. Additionally, 100% of Dr. Vitt’s outstanding equity awards vested as of the Separation Date, and Dr. Vitt will have three (3) years following the Separation Date to exercise any vested equity awards. The Company also agreed to reimburse Dr. Vitt for legal fees incurred in connection with the negotiation of the Separation Agreement, up to a maximum of $20,000.
The foregoing description of the Separation Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On August 10, 2026, the Company issued a press release announcing the appointment of Ms. Ridloff. A copy of the press release is furnished as Exhibit 99.2 hereto and is incorporated herein by reference. The information set forth in this Item 7.01 and in Exhibit 99.2 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section. The information in this Item 7.01 and in Exhibit 99.2 shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits
| Exhibit | Description |
| 10.1 | Separation Agreement, dated as of August 7, 2026, between Immunic, Inc. and Dr. Daniel Vitt. |
| 99.1 | Press Release dated August 10, 2026. |
| 99.3 | Press Release dated August 11, 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: August 11, 2026 |
Immunic, Inc. | |
| By: | /s/ Erik Lundgren | |
| Erik Lundgren | ||
| Chief Executive Officer | ||
Immunic Appoints Elena Ridloff to Board of Directors
– Appointment Strengthens Board with Financial, Capital Markets and Commercial Leadership Expertise as the Company Approaches Pivotal Phase 3 ENSURE Readout in Relapsing Multiple Sclerosis as well as Potential Regulatory Filings and Commercialization –
NEW YORK, August 10, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Elena Ridloff, CFA to its Board of Directors, effective August 6, 2026. Ms. Ridloff brings more than two decades of experience driving financial strategy, corporate growth, and capital markets execution across the biopharmaceutical industry.
“We are excited to welcome Elena to our Board as we enter an important period for Immunic,” commented Michael
W. Bonney, Chair of Immunic’s Board of Directors. “Ms. Ridloff is a highly respected biotech executive with a proven track
record of helping companies navigate periods of transformational growth. We are delighted to welcome her to the Board and look forward
to the valuable insights and perspectives she will bring.”
Erik Lundgren, Chief Executive Officer of Immunic, added, “With top-line data from our Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (MS) expected by year-end and the planned initiation of our confirmatory Phase 3 program in progressive MS, we are executing towards a series of milestones that have the potential to define Immunic’s next phase of growth. Elena’s experience building and advising high-growth biopharma companies will be invaluable as we continue to unlock vidofludimus calcium’s potential across MS patient populations. I look forward to working closely with her as we move into this next phase.”
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 at Sionna Therapeutics. Previously, Ms. Ridloff
served as Executive Vice President and Chief Financial Officer of ACADIA Pharmaceuticals, where she led the finance organization and played
a key role in the company's commercial growth, business development, pipeline expansion, and successfully raising $600 million in capital.
Earlier in her career, she established and led the investor relations function at Alexion Pharmaceuticals, was Chief Executive Officer
of BIOVISIO, an independent consulting firm serving the life sciences industry, and served as a Managing Director at Maverick Capital,
a hedge fund, leading healthcare and life sciences investments. Ms. Ridloff also serves on the Board of Directors of Kymera Therapeutics,
where she chairs the Audit Committee, and previously served on the Board of Directors of Kronos Bio. She holds a B.A. in History and Sociology
of Science from the University of Pennsylvania and is a CFA charterholder.
“I am honored to join Immunic’s Board at such an exciting stage in the company’s evolution,” said Ms. Ridloff. ”Immunic has assembled an exceptional team with deep expertise in MS and is advancing a differentiated oral program designed with the potential to become a meaningful franchise opportunity spanning both relapsing and progressive forms of MS. With important clinical milestones ahead, I look forward to working alongside the Board and management team to help advance vidofludimus calcium and support the successful execution of the company’s long-term strategy.”
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 being evaluated in Phase 3 clinical trials for the treatment of relapsing multiple sclerosis, with top-line data expected to be available by the end of 2026. Initiation of an additional Phase 3 clinical trial in progressive MS is expected later in 2026. Vidofludimus calcium has already shown therapeutic potential and a favorable safety and tolerability profile 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-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune 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; new appointments to Immunic’s board of directors; 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, 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
LifeSci Advisors
Joyce Allaire
immunic@lifesciadvisors.com
US Media Contact
Real Chemistry
media@imux.com
Immunic, Inc. Reports Second
Quarter 2026 Financial Results and Provides Corporate Update
– Leadership Team Expanded with Key Executive Appointments, Including Chief Executive Officer, Chief Medical Officer and Chair of the Board of Directors, to Support Clinical Development, as well as NDA and Commercial Readiness –
– Pivotal Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis on Track, with Top-Line Data Expected by End of 2026 –
– Continued Preparations for Phase 3 Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis, with Initiation Planned Later This Year –
NEW YORK, August 11, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.
“During the second quarter, we continued to execute across our late-stage development priorities as we advance toward what we believe will be a transformational period for Immunic,” said Erik Lundgren, Chief Executive Officer of Immunic. “As we prepare for the next stage of Immunic’s growth, we have continued to strengthen our board and team with world-class multiple sclerosis (MS) experts whose extensive development, medical, regulatory and commercialization expertise will be instrumental as we execute on our clinical strategy and prepare for the potential regulatory filings and commercialization of vidofludimus calcium (IMU-838). Following the successful closing of our oversubscribed private placement financing earlier this year, we are well capitalized to execute on our key strategic priorities. We believe the milestones ahead position Immunic for a significant near-term value inflection for vidofludimus calcium in relapsing MS, while continuing to unlock the substantial long-term opportunity across the broader progressive MS patient population.”
Jason Tardio, President and Chief Operating Officer of Immunic, commented, “We remain highly encouraged by the consistent and differentiated profile of vidofludimus calcium, supported by additional data from our Phase 2 CALLIPER trial in progressive MS presented at this year's CMSC Annual Meeting, including favorable safety, tolerability, patient-reported, and exploratory efficacy data. Taken together, these findings reinforce our confidence in the potential of vidofludimus calcium to offer a differentiated benefit/risk profile through its novel dual mechanism of action, combining Nurr1 activation with selective DHODH inhibition. We believe this approach has the potential to deliver meaningful efficacy while maintaining the favorable safety and tolerability profile observed to date, positioning vidofludimus calcium as a potentially important new oral treatment option for people living with MS.”
“Our Phase 3 ENSURE trials of vidofludimus calcium in relapsing MS remain on track to report top-line data by the end of 2026,” added Michael A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. “With regulatory alignment and precedent surrounding the time to first relapse primary endpoint, the path to regulatory submission upon positive trial results is clear. In parallel, we are preparing to initiate our Phase 3 progressive MS trial later this year, reinforcing our commitment to evaluating the potential of vidofludimus calcium for anyone living with MS.”
Second Quarter 2026 and Subsequent Highlights
| · | Ongoing Phase 3 ENSURE Relapsing MS Program: Continued to execute the twin Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing MS. |
| · | Preparation of Phase 3 Progressive MS Program: Continued preparations for a confirmatory Phase 3 program in progressive MS, building on the Phase 2 CALLIPER trial data. |
| · | Additional Phase 2 CALLIPER Data Presented at CMSC Annual Meeting: Presented one late-breaking and two additional posters of new data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive MS at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The new analyses, which included a novel unified confirmed disability change (CDC) endpoint, up to 120 weeks of patient-reported outcomes, and safety and tolerability data, further reinforced the favorable profile of vidofludimus calcium and its potential to address underlying drivers of disability progression in progressive MS. |
| · | Expansions in Management and Board of Directors: |
| o | Appointment of Erik Lundgren as Chief Executive Officer, effective May 22, 2026, with employment having begun on June 1, 2026. Mr. Lundgren is a biopharmaceutical executive with nearly two decades of commercial leadership experience, including senior roles at Genentech and Roche supporting the launch of Ocrevus® for relapsing and primary progressive MS. On July 5, 2026, Mr. Lundgren was also appointed to serve as a Director of the Board. |
| o | Appointment of Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer, effective April 24, 2026. Dr. Panzara brings over 25 years of global neurology experience and proven leadership in advancing transformational therapies through development and regulatory approval processes. Dr. Panzara oversaw the global regulatory approvals of the MS drugs Lemtrada® and Aubagio® during his tenure at Sanofi Genzyme. During his time at Biogen, he served as global clinical lead for the development of Tysabri® and managed the late-stage MS portfolio. |
| o | In addition, Michael W. Bonney has been appointed as Chair of the Board of Directors, effective May 16, 2026. Mr. Bonney is a seasoned biopharmaceutical executive with more than three decades of leadership experience, including senior commercial roles at Biogen tied to the launch and growth of Avonex® for relapsing MS and CEO experience at Cubist Pharmaceuticals. Simona Skerjanec, M.Pharm, M.B.A., transitioned from Interim Chairperson to continue serving as a Board member. |
| o | Appointment of Elena Ridloff 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 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 by the end of 2026. If positive, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. |
| · | Vidofludimus Calcium in Progressive MS: The planned initiation of a Phase 3 program in progressive MS remains on track for later this year. |
| · | 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 six months ended June 30, 2026 were $35.3 million and $68.6 million, respectively. Included in these results are $7.2 million and $11.7 million, respectively, of non-cash charges, primarily related to stock compensation expense.
Research and Development (R&D) Expenses were $25.9 million for the three months ended June 30, 2026, as compared to $21.3 million for the three months ended June 30, 2025. The $4.6 million increase reflects (i) a $4.4 million increase in personnel expenses, $3.2 million of which was related to non-cash stock compensation, (ii) a $1.6 million increase due to drug-drug interaction studies in support of a potential NDA filing, (iii) a $1.1 million increase related to costs across numerous categories, partially offset by (iv) a $2.0 million decrease related to the CALLIPER clinical trial and (v) a $0.5 million decrease related to the ENSURE clinical trials.
For the six months ended June 30, 2026, R&D expenses were $51.6 million, as compared to $42.9 million for the six months ended June 30, 2025. The $8.7 million increase reflects (i) a $5.4 million increase in personnel expenses, $3.8 million of which was related to non-cash stock compensation, (ii) a $3.9 million increase due to drug-drug interaction studies in support of a potential NDA filing, (iii) a $3.1 million increase for vidofludimus calcium drug supply and (iv) a $1.3 million increase related to costs across numerous categories, partially offset by (v) a $2.8 million decrease related to the CALLIPER clinical trial and (vi) a $2.2 million decrease related to the ENSURE clinical trials.
General and Administrative (G&A) Expenses were $9.4 million for the three months ended June 30, 2026, as compared to $5.7 million for the same period ended June 30, 2025. The $3.7 million increase was due to (i) a $2.1 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation, (ii) a $0.7 million increase in legal and consultancy expenses, (iii) a $0.4 million increase in pre-commercial marketing expenses, and (iv) a $0.5 million increase in related costs across numerous categories.
For the six months ended June 30, 2026, G&A expenses were $17.0 million, as compared to $11.0 million for the same period ended June 30, 2025. The $6.0 million increase was due to (i) a $4.2 million increase related to personnel expenses, of which $3.6 million was related to non-cash stock compensation, (ii) a $1.0 million increase in legal and consultancy expenses, (iii) a $0.6 million increase in pre-commercial marketing expenses, and (iv) a $0.2 million increase in related costs across numerous categories.
Interest Income was $1.3 million for the three months ended June 30, 2026, as compared to $0.3 million for the three months ended June 30, 2025. The $1.0 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement.
For the six months ended June 30, 2026, interest income was $2.0 million, as compared to $0.4 million for the same period ended June 30, 2025. The $1.6 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement.
Other Income (Expense) was ($0.06) million for the three months ended June 30, 2026, as compared to $0.02 million for the same period ended June 30, 2025.
For the six months ended June 30, 2026, Other Income (Expense) was ($0.2 million), as compared to $1.2 million for the same period ended June 30, 2025. The $1.4 million decrease was primarily attributable to (i) a $1.0 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 $0.4 million decrease across various categories.
Net Loss for the three months ended June 30, 2026, was approximately $34.1 million, or $0.80 per basic and diluted share, based on 42,513,839 weighted-average common shares outstanding, compared to a net loss of approximately $26.8 million, or $2.03 per basic and diluted share, based on 13,217,520 weighted-average common shares outstanding for the same period ended June 30, 2025.
Net loss for the six months ended June 30, 2026, was approximately $66.7 million, or $1.83 per basic and diluted share, based on 36,359,274 weighted average common shares outstanding, compared to a net loss of approximately $52.3 million or $4.48 per basic and diluted share, based on 11,684,499 weighted average common shares outstanding for the same period ended June 30, 2025.
Cash and Cash Equivalents as of June 30, 2026 were $155.1 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 being evaluated in Phase 3 clinical trials for the treatment of relapsing multiple sclerosis, with top-line data expected to be available by the end of 2026. Initiation of an additional Phase 3 clinical trial in progressive MS is expected later in 2026. Vidofludimus calcium has already shown therapeutic potential and a favorable safety and tolerability profile 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-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune 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, 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
LifeSci Advisors
Joyce Allaire
immunic@lifesciadvisors.com
US Media Contact
Real Chemistry
media@imux.com
Financials
Immunic, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| June 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 155,098 | $ | 15,483 | ||||
| Other current assets and prepaid expenses | 2,735 | 7,386 | ||||||
| Total current assets | 157,833 | 22,869 | ||||||
| Property and equipment, net | 771 | 608 | ||||||
| Right-of-use assets | 565 | 575 | ||||||
| Total assets | $ | 159,169 | $ | 24,052 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,665 | $ | 10,138 | ||||
| Accrued expenses | 17,852 | 18,645 | ||||||
| Other current liabilities | 743 | 1,835 | ||||||
| Total current liabilities | 31,260 | 30,618 | ||||||
| Long term liabilities | ||||||||
| Operating lease liabilities | 328 | 107 | ||||||
| Total long-term liabilities | 328 | 107 | ||||||
| Total liabilities | 31,588 | 30,725 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 20,000,000 shares authorized and no shares issued or outstanding as of June 30, 2026 and December 31, 2025 | — | — | ||||||
| Common stock, $0.0001 par value; 500,000,000 shares authorized as of June 30, 2026 and December 31, 2025, and 13,644,467 and 12,038,263 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively | 13 | 9 | ||||||
| Additional paid-in capital | 800,054 | 599,241 | ||||||
| Accumulated other comprehensive income | 2,772 | 2,648 | ||||||
| Accumulated deficit | (675,258 | ) | (608,571 | ) | ||||
| Total stockholders’ equity (deficit) | 127,581 | (6,673 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 159,169 | $ | 24,052 | ||||
Immunic, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 25,931 | $ | 21,369 | $ | 51,557 | $ | 42,902 | ||||||||
| General and administrative | 9,396 | 5,714 | 17,005 | 11,006 | ||||||||||||
| Total operating expenses | 35,327 | 27,083 | 68,562 | 53,908 | ||||||||||||
| Loss from operations | (35,327 | ) | (27,083 | ) | (68,562 | ) | (53,908 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,286 | 241 | 2,046 | 424 | ||||||||||||
| Other income (expense), net | (58 | ) | 22 | (171 | ) | 1,191 | ||||||||||
| Total other income | 1,228 | 263 | 1,875 | 1,615 | ||||||||||||
| Net loss | $ | (34,099 | ) | $ | (26,820 | ) | $ | (66,687 | ) | $ | (52,293 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.80 | ) | $ | (2.03 | ) | $ | (1.83 | ) | $ | (4.48 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 42,513,839 | 13,217,520 | 36,359,274 | 11,684,499 | ||||||||||||