IMUX 10-K & 10-Q changes, risk factors and insider trading
Immunic, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1280776 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our most advanced product candidate requires successful completion of Phase 3 clinical trials and additional development activities before regulatory approval may be obtained, and any delays or failures could materially adversely affect our business.”
New heading “A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.”
New heading “If our stockholders fail to approve a reverse stock split of our common stock, our business and operations will be materially negatively impacted, because we will be unable to issue additional shares of common stock and our common stock may be delisted from The Nasdaq Capital Market.”
New heading “We intend to effect a reverse stock split, which may not achieve its intended objectives and could negatively affect the market price and liquidity of our common stock. We also have a significant number of warrants which are either exercisable for shares of common stock now, or will be exercisable for shares of common stock following receipt of the Reverse Split Stockholder Approval, and we are obligated to file a resale registration statement with the SEC to cover a significant number of shares of common stock for resale by certain selling stockholders.”
Removed heading “Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability continue as a “going concern.”
Largest changes
“•Our business and clinical development timelines could be adversely affected by macroeconomic conditions and global events, including inflation, changes in interest rates, tariffs and retaliatory measures, supply chain disruptions, public health crises and geopolitical conflicts, including the ongoing military action involving Russia and Ukraine.”see in full comparison
“On October 1, 2025, the federal government of the United States began a shutdown at 12:01 a.m. EDT as a result of congressional failure to pass appropriations legislation for the 2026 fiscal year, which began that day, and lasted for 43 days. Subsequent partial federal government shutdowns occurred in January and February of 2026. A continued and prolonged shutdown could materially and adversely affect our business, operations, financial condition, and legal matters. …”see in full comparison
“If our stockholders fail to approve a reverse stock split of our common stock, our business and operations will be materially negatively impacted, because we will be unable to issue additional shares of common stock and our common stock may be delisted from The Nasdaq Capital Market.”see in full comparison
“Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability continue as a “going concern.”see in full comparison
“We intend to effect a reverse stock split, which may not achieve its intended objectives and could negatively affect the market price and liquidity of our common stock. We also have a significant number of warrants which are either exercisable for shares of common stock now, or will be exercisable for shares of common stock following receipt of the Reverse Split Stockholder Approval, and we are obligated to file a resale registration statement with the SEC to cover a significant number of shares of common stock for resale by certain selling stockholders.”see in full comparison
“If we are unable to obtain the Reverse Split Stockholder Approval, or otherwise increase the number of authorized shares available for issuance on a timely basis, our ability to raise additional capital, satisfy contractual obligations requiring the issuance or reservation of shares, pursue strategic transactions, or provide equity-based compensation could be materially limited. Any delay or inability to access equity financing or complete strategic transactions could adversely affect our liquidity, financial condition, and ability to execute our business strategy. …”see in full comparison
Full comparison: every changed paragraph (104)
•Our business could be materially and adversely affected in the future by the effects of disease outbreaks, epidemics and pandemics.
•Continued inflation and uncertainty in global economic conditions could negatively affect our business, results of operations and financial condition.
•Our clinical trials have been delayed as a result of the ongoing military action by Russia in Ukraine and the continuation of this conflict could have further adverse effects on our business.
•We haveare a clinical-stage company with a limited operating history with our current business plan,history, have incurred significant losses since 2016, anticipateexpect that we willto continue to incur significant and increasing losses for the foreseeable future and may never achieve or maintain profitability. The absence of any commercial sales and our limited operating history make it difficult to assess our future viability.
•We currently have no source of product sales revenue and may never earngenerate product revenue or be profitable.revenue.
•We will require substantial additional funding in the current year,capital, and aour failure to obtain this necessary capitalfinancing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our productdevelopment development, other operationsprograms or future commercialization efforts.efforts; additional financings may be dilutive and may impose significant restrictions on our operations.
•Our business and clinical development timelines could be adversely affected by macroeconomic conditions and global events, including inflation, changes in interest rates, tariffs and retaliatory measures, supply chain disruptions, public health crises and geopolitical conflicts, including the ongoing military action involving Russia and Ukraine.
•Our success depends on the timely and successful development of our product candidates, and clinical development is lengthy, expensive and uncertain; clinical failure can occur at any stage and results from earlier studies may not be predictive of later results.
•Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
•The marketing approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed.
•Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
•Clinical failure can occur at any stage of clinical development. Because the results of earlier clinical trials are not necessarily predictive of future results, any product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive marketing approval. The effect of failure or results different than expectations can result in significant market value decline and possible negative financial results or asset impairment.
•Our product candidates may cause undesirable adverse effects or have other propertiescharacteristics that could delay or prevent their marketingregulatory approval, limit the commercial profile of an approved labellabeling, or result in significant negative consequences following marketing approval, if approval is obtained.
•The regulatory approval process is lengthy, time-consuming and inherently unpredictable, and we may be unable to obtain or maintain marketing approval for our product candidates.
•Even if approved, our ability to successfully commercialize any product candidates will depend on market acceptance, our ability to build or access sales and marketing capabilities, third-party coverage and reimbursement, and our ability to compete effectively.
•We are heavily dependent on the success of our product candidates, which are in the early to late stages of clinical development. We may not be able to generate data for any of our product candidates sufficient to receive regulatory approval in our planned indications, which will be required before they can be commercialized.
•Due to our limited resources and access to capital, we must decide to prioritize development of our current product candidates for certain indications and at certain doses. These decisions may prove to have been wrong and may materially adversely affect our business, financial condition, results of operations and prospects.
•If we fail to attract and retain key management and scientific personnel, we may be unable to successfully develop or commercialize our product candidates.
•Even if we obtain the required regulatory approvals in the United States and other territories, the commercial success of our product candidates will depend on market awareness and acceptance of our product candidates.
•We currently have limited marketing and sales experience. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, if and when regulatory approval is received, we may be unable to generate any revenue.
•If we fail to enter into strategic relationships or collaborations, our business, financial condition, drug development plans, commercialization prospects and results of operations may be materially adversely affected.
•Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our products profitably.
•We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do.
•TheWe sizeface ofsignificant competition, and the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual marketssize for our product candidates may be substantially smaller than ourwe estimates.estimate.
•We depend on our ability to attract and retain key personnel and to establish and maintain strategic relationships and collaborations, and we may not realize the anticipated benefits of any such arrangements.
•We may be unable to realize the potential benefits of any collaboration that we might enter into in the future.
•Our proprietary rights may not adequately protect our technologies and product candidates.
•WeOur may not be ableability to protect and enforce our intellectual property rights throughoutis theuncertain, world.and failure to do so could impair our competitive position.
•We are subject to the risks and costs of operating as a public company, and our failure to meet Nasdaq continued listing requirements, including the $1.00 minimum bid price requirement, could result in delisting.
•Intellectual property rights do not protect against all potential threats to our potential competitive advantage.
•We incur significant costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
•Our failure to meet the $1.00 minimum bid price or other continued listing requirements of Nasdaq could result in a delisting of our common stock, which would negatively impact the market price and liquidity of our common stock and our ability to access the capital markets.
•The market price of our common stock has been and is expected tomay continue to be volatile.volatile, and we do not expect to pay cash dividends in the foreseeable future.
•We do not anticipate that we will pay any cash dividends in the foreseeable future.
Adverse macroeconomic conditions, including inflation, slower growth or recession, higher interest rates, currency fluctuations, supply chain delays or shortages, high unemployment or personnel shortages could hurt our business. We have continued to see a general increase in many of our costs as a result of inflation, although inflation has not yet had a material impact on our results of operations. However, the economies of Germany, the United States, Australia and other countries in which we do business have experienced high rates of inflation duringin 2022,recent 2023 and 2024years, and, if inflation were to continue for a prolonged period of time or the rate of inflation in our markets were to increase, or if a global recession were to occur, our expenses could increase substantially, resulting in increased losses from operations and net loss. A downturn in the economic environment can also lead to limitations on our ability to obtain financing, reduced liquidity and declines in our stock price.
Our clinical trials of vidofludimus calcium were originally planned to be conducted at more than 60 sites in Ukraine and Russia, but most had to be relocated to other countries because of the invasion of Ukraine by Russia in February 2022 and resulting sanctions imposed on Russia by the United States and other countries. These disruptions delayed our clinical development program, increased our costs and may disrupt future planned clinical development activities in these two countries. This military action has continued for more than three years and its future course and effects on our Company are highly unpredictable. We currently have approximately 35 active sites in western Ukraine and the ongoing conflict could put the data associated with these patients inat jeopardyrisk as well as extend patient recruitment timelines. Ukraine is expected to make up a significant percentage of our ENSURE- 1 and ENSURE-2 phase 3 patient population. Alternative sites to fully and timely compensate for our clinical trial activities in Ukraine may not continue to be available. If our clinical trials are further interrupted, our clinical development program could experience further delays and increased costs and we may have insufficient data to support regulatory approvals of vidofludimus calcium, and any commercialization may be delayed or not approved, which could limit our potential revenue and hurt the competitive position of our potential products.
We do not expect to generate significant revenue unless and until we are able to obtain marketing approval for, and successfully commercialize, any current or future product candidate. However pharmaceutical product development is an extremely costly and highly speculative undertaking and involves a substantial degree of risk. In addition, if we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive regulatory approval, and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for our product candidates. Even if we eventually obtain adequate market share for our product candidates, to the extent they receive regulatory and marketmarketing approval and authorization for reimbursement, the potential markets for our product candidates may not be large enough for us to become profitable.
We have approximately $15.5 million of cash and cash equivalents as of December 31, 2025. On February 17, 2026 we announced the closing of a private placement with net cash proceeds of $187.0 million. With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements. Our estimate as to how long we expect our existing cash and cash equivalents to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume cash and cash equivalents significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Our future capital requirements depend on many factors, including:
We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic collaborations and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of such equity or convertible debt securities may include liquidation or other preferences that adversely affect the rights of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, acquire or license intellectual property rights, redeem stock or declare dividends, and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic collaborations and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us. As part of the January 2024 Financing, tranche 2 of this financing could result in an additional $80 million of funding at a price of $1.716 which would result in an additional 46.6 million of common stock being issued.
Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability continue as a “going concern.
The auditor’s opinion on our audited consolidated financial statements for the year ended December 31, 2024 includes an explanatory paragraph stating that our losses and negative cash flows from operations and uncertainty in generating sufficient cash to meet our operating obligations raise substantial doubt about our ability to continue as a “going concern.” Although we have continued to pursue a variety of funding sources and transactions that could potentially raise capital, we have not been successful in these efforts since January 2024, and possible sources of funding may be unwilling to provide additional funding on commercially reasonable terms, or at all, following the issuance by Baker Tilly US. LLP of a “going concern” opinion. If we are unable to obtain sufficient funding to continue as a going concern, we will be forced to cease operations and seek to liquidate our assets. We may receive substantially less than the value at which those assets are carried on our audited consolidated financial statements, and it is likely that investors will lose all or a substantial part of their investment.
•the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application (“NDA”) to obtain marketing approval in the United States or elsewhere;
Policies and actions of the newU.S. administrationfederal ofgovernment, Presidentincluding Trumpchanges in leadership, priorities, staffing levels, funding, and regulatory approaches could lead to additional uncertainties and delays in the FDA review and approval processes. Announced intentions to decrease headcount and expenses at government agencies, reduce regulation and increase government efficiency, and other initiatives could result in our incurring substantial additional time and expense to complete the development of, and seek and obtain marketing approval for, our product candidates in a timely manner.
Our most advanced product candidate requires successful completion of Phase 3 clinical trials and additional development activities before regulatory approval may be obtained, and any delays or failures could materially adversely affect our business.
For our most advanced indication, RMS, marketing approval will depend on the successful completion of one or more adequate and well-controlled Phase 3 clinical trials. Phase 3 development is costly and resource-intensive and typically spans multiple years. Clinical trials are inherently unpredictable, and studies that are initiated as planned may be delayed, require modification or fail to produce results sufficient to support approval. Protocol amendments, safety observations, manufacturing constraints, evolving regulatory expectations or inconclusive efficacy data may each effect trial timing or outcomes. Additional preclinical and clinical work will also be required to support regulatory submissions. Regulatory feedback during development may alter the scope or timing of required studies, which could increase costs or extend development timelines. We must also establish manufacturing processes capable of supporting commercial supply. This includes scaling production, validating manufacturing methods and implementing controls designed to demonstrate consistent product quality and compliance with applicable regulatory requirements. Manufacturing development and validation are complex and may require significant investment and regulatory review. Even where clinical results are favorable, difficulties in developing or validating manufacturing capabilities may delay or prevent approval. If clinical development, supporting studies or manufacturing readiness activities are delayed or unsuccessful, regulatory approval may be postponed or not obtained, which would limit our ability to commercialize this product candidate and could materially adversely affect our business, financial condition and results of operations.
It is impossible to predict the extent to which the clinical trial process may be affected by existing or prospective legislative and regulatory developments or changes in regulatory priorities, guidance or review practices.
It is impossible to predict the extent to which the clinical trial process may be affected by existing or prospective legislative and regulatory developments or initiatives to reduce or eliminate regulation, decrease headcount and expenses at government agencies, and increase government efficiency. Due to these and other factors, our current or future product candidates could take significantly longer and cost more than expected to gain marketing approval, if at all. This could delay or eliminate any potential product revenue by delaying or terminating the potential commercialization of our current product candidates.
•the delay or refusal of regulators or institutional review boards (“IRBs”) at the medical institutions where the clinical trials are conducted.conducted to authorize us to commence a clinical trial at a prospective trial site;
•regulators or IRBs requiring that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or adverse events experienced by participants in clinical trials;
A number of pharmaceutical companies have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical or preclinical testing.
A number of pharmaceutical companies have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical or preclinical testing. For example, we•We announced in October 2022 the analysis of interim group-level data of our Phase 1b clinical trial of IMU-935 in patients with moderate-to-severe psoriasis did not separate from placebo. Following this announcement, our stock price declined significantly, which caused us to record a full impairment of our goodwill in the quarter ended December 31, 2022. Data obtained from trials are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent marketing approval of our product candidates. In addition, the design of a clinical trial can determine whether its results will support approval of a product, or approval of a product for desired indications, and flaws or shortcomings in the design of a clinical trial may not become apparent until the clinical trial is well advanced. We have limited experience in designing clinical trials and may be unable to properly design and execute a clinical trial to support marketing approval for our desired indications. Further, clinical trials of product candidates often reveal that it is not practical or feasible to continue development efforts. If one of our product candidates is found to be unsafe or lack efficacy, we will not be able to obtain marketing approval for such product candidate and our business would be harmed. If the results of our clinical trials of our product candidates do not achieve pre-specified endpoints, we are unable to provide primary or secondary endpoint measurements deemed acceptable by the FDA or comparable foreign regulators, or we are unable to demonstrate an acceptable level of safety relative to the efficacy associated with our proposed indications, the prospects for approval of our product candidates would be materially and adversely affected. For example, we announced in June 2022 that a phase 2 clinical trial of our most advanced drug candidate, vidofludimus calcium, did not achieve its primary endpoint in patients with moderate-to-severe ulcerative colitis. As a result, we do not plan any further drug development activities in ulcerative colitis without a partner. A number of companies in the pharmaceutical industry, including those with greater resources and experience than we, have suffered significant setbacks in Phase 2 and Phase 3 clinical trials, even after seeing promising results in earlier clinical trials.
•In October 2024, an independent data monitoring committee, or IDMC, conducted a non-binding, interim futility analysis of our Phase 3 ENSURE program for the treatment of RMS and reported that the trials are not futile and should continue as planned. In addition, the IDMC recommended that we continue the trials without any adjustment to the sample sizes of each trial. There can be no assurances that the observations made at the interim regarding futility will be consistent with the final study results for various reasons, including that the final study results based upon the full sample size may not be consistent with the results achieved by the limited sample size used to conduct the interim analysis and the current sample size of approximately 1,050 adult patients with active RMS in each trial may not be sufficiently large to demonstrate efficacy.
•In February 2025, we reported that IMU-856, our orally available small molecule modulator targeting SIRT6, demonstrated a dose-dependent increase in endogenous glucagon-like peptide-1 levels in a post-hoc analysis of patients from our Phase 1b clinical trial in celiac disease, and dose-dependent reductions in body weight gain and food consumption in preclinical in vivo testing. These data suggest potential effects on GLP-1 and weight management; however, such findings arise from a post-hoc analysis of a small Phase 1b study and preclinical models, which are inherently subject to limitations.
•In April 2025, we announced data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis, including a reported reduction in the relative risk of 24-week confirmed disability worsening events by approximately 20% in the overall PMS population and by approximately 30% in the primary progressive multiple sclerosis subgroup compared to placebo.
•In June 2025, we reported new, positive long-term open-label extension data from our Phase 2 EMPhASIS trial of vidofludimus calcium for the treatment of relapsing-remitting multiple sclerosis. The OLE portion of the EMPhASIS trial is ongoing and is generally designed to evaluate longer-term safety and tolerability and to explore longer-term outcomes; however, OLE data are inherently subject to important limitations, including the absence of a concurrent control group, potential selection bias (including that patients who remain in the OLE may differ from those who discontinue participation), and the potential influence of confounding factors.
Notwithstanding any of the foregoing, many companies in the pharmaceutical industry, including those with greater resources and experience than we, have suffered significant setbacks in Phase 2 and Phase 3 clinical trials, even after seeing promising results in earlier clinical trials.
In October 2024, an independent data monitoring committee, or IDMC, conducted a non-binding, interim futility analysis of our phase IMU-838 3 ENSURE program for the treatment of RMS and reported that the trials are not futile and should continue as planned. In addition, the IDMC recommended that we continue the trials without any adjustment to the sample sizes of each trial. There can be no assurances that the observations made at the interim regarding futility will be consistent with the final study results for various reasons, including that the final study results based upon the full sample size may not be consistent with the results achieved by the limited sample size used to conduct the interim analysis and the current sample size of approximately 1,050 adult patients with active RMS patients for each trial may not be sufficiently large to demonstrate efficacy.
We have invested substantially all of our efforts and financial resources to identify, acquire and develop our portfolio of product candidates. Our future success is dependent on our ability to successfully further develop, obtain regulatory approval for, and commercialize one or more product candidates. We currentlyhave generatenever nogenerated revenue from sales of any products, and we may never be able to develop or commercialize a product candidate.
Our most advanced product candidate, vidofludimus calcium, had the first patient enrolled in a Phase 3 program for relapsing multiple sclerosis (“RMS”) in November 2021 and we do not expect the readout of topline data from this trial until the middleend of 2026. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates. We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations.
The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval, manufacturing or commercialization of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislationlegislation, executive orders or administrative action, either in the United States or other jurisdictions. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or not able to maintain regulatory compliance, we may lose any marketing approval that may have been obtained and we may not achieve or sustain profitability, which would adversely affect our business.
Management's Discussion & Analysis (MD&A)
New heading “Key Status Updates”
New heading “Special Meeting and Reverse Stock Split”
New heading “Royalty Purchase Agreement”
New heading “Changes to the Board of Directors – Appointment of Director”
New heading “Changes to the Board of Directors – Appointment of Chair”
New heading “Changes to the Board of Directors – Resignation of Director”
New heading “Received Notice of Allowance from the United States Patent and Trademark Office Protecting Vidofludimus Calcium's Dose Strengths in PMS”
New heading “Completion of Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in RMS”
New heading “Additional Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in PMS”
New heading “Vidofludimus Calcium Reduced Risk of Disability Worsening in Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial”
New heading “Transfer of Nasdaq Market Listing and Notice of Non-Compliance with Nasdaq Listing Rule 5450(a)(1)”
New heading “Stock Appreciation Rights ("SARs")”
New heading “Liquidity and Financial Condition”
New heading “Private Placement of up to $240 Million (the "January 2024 Financing")”
Removed heading “Private Placement of up to $240 Million (The "January 2024 Offering")”
Removed heading “Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States”
Removed heading “Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS in the Peer Reviewed Journal, Neurology® Neuroimmunology & Neuroinflammation”
Removed heading “Appointment of Jason Tardio as Chief Operating Officer and President and Promotion of Werner Gladdines to Chief Development Officer”
Removed heading “Appointment of Simona Skerjanec to Board of Directors”
Removed heading “Hosted Two Multiple Sclerosis R&D Days in New York City and San Francisco”
Removed heading “Announced Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology”
Removed heading “Financial Condition, Liquidity and Going Concern”
Removed heading “Janaury 2024 Financing of up to $240 Million”
Removed heading “Future Accounting Standards”
Largest changes
“Financial Condition, Liquidity and Going Concern”see in full comparison
From inception through December 31,see in full comparison2024,2025, we have raised net cash of approximately$430.9$496.3 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights. As of December 31,2024,2025, we had cash and cash equivalents of approximately$35.7$15.5 million. On February 17, 2026, we announced the closing of a private placement with net cash proceeds of approximately $187.0 million. With thesefunds,fundstheweCompanyexpectdoestonotbehave adequate liquidityable to funditsour operationsfor at leastbeyond twelve months from the date of the issuance ofthesethe accompanying consolidated financialstatements without raising additional capital, and such actions are not solely within the control of the Company. If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether. These factors raise substantial doubt about the Company’s ability to continue as a going concern.statements.
“In connection with the February 2026 Offering, we and each February 2026 Investor entered into a registration rights agreement simultaneously with the February 2026 Securities Purchase Agreement (the “February 2026 Registration Rights Agreement”). …”see in full comparison
“In connection with the February 2026 Offering, we and each February 2026 Investor entered into a registration rights agreement simultaneously with the February 2026 Securities Purchase Agreement (the “February 2026 Registration Rights Agreement”). …”see in full comparison
“As previously disclosed, on June 27, 2025, we received a letter from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1) because the closing bid price per share for Common Stock had closed below $1.00 for the previous 30 consecutive business days (the “Bid Price Rule”). We were given a 180-day grace period, until December 24, 2025, to regain compliance with the rule. We had not regained compliance with the Bid Price Rule by December 24, 2025. …”see in full comparison
Full comparison: every changed paragraph (152)
Immunic, Inc. ("“Immunic," “we,” “us,” “our” or the "Company") is a late-stage biotechnology company developingpioneering athe clinical pipelinedevelopment of selectivenovel oral immunology therapies focusedfor on treating chronic inflammatoryneurologic and autoimmunegastrointestinal diseases. We are headquartered in New York City with our main operations in Gräfelfing near Munich, Germany. We had 9192 employees as of MarchFebruary 1, 2025.2026.
We are pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases. These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 and Phase 2 clinical development for patients with relapsing and progressive multiple sclerosis (“MSRMS”), respectively, and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MSmultiple sclerosis ("RRMS"), progressive MSmultiple sclerosis (”PMS”) and moderate-to-severeother ulcerative colitis (“UC”)diseases; the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease (“IBD”), and Graft-versus-Host-Disease ("GvHD") and weight management; and the IMU-381 program, which iscomprises anext-generation nextmolecules generationin moleculepreclinical beingtesting developedfor to specifically address the needs ofneurologic, gastrointestinal diseases.and other autoimmune diseases leveraging our nuclear receptor-related 1 (“Nurr1”) platform.
Key Status Updates
On February 12, 2026, we into a securities purchase agreement (the “February Securities Purchase Agreement”) with certain accredited investors (the “February Investors”), pursuant to which we agreed to issue and sell, in a private placement (the “February 2026 Offering”), pre-funded warrants (the “February 2026 Pre-Funded Warrants”, and the shares of Common Stock issuable upon exercise of the February 2026 Pre-Funded Warrants, the “February 2026 Pre-Funded Warrant Shares”) to purchase up to 0.0001 shares of Common Stock, with each February 2026 Pre-Funded Warrant accompanied by a warrant to purchase (i) a share of Common Stock or (ii) a pre-funded warrant to purchase a share of Common Stock (collectively, the “February 2026 Common Warrants” and together with the February 2026 Pre-Funded Warrants, the “February 2026 Warrants”, and the shares of Common Stock issuable upon exercise of the February 2026 Common Warrants, the “February 2026 Common Warrant Shares”, and together with the February 2026 Pre-Funded Warrant Shares, the “February 2026 Warrant Shares”).
The purchase price for each February 2026 Pre-Funded Warrant and accompanying February 2026 Common Warrant was $0.873120. Each February 2026 Pre-Funded Warrant is immediately exercisable at a price of $0.0001 per share. Each February 2026 Common Warrant is exercisable at a price $0.873220 per share (subject to adjustment as set forth therein) following the completion of the Reverse Stock Split (as defined below) until the earlier of (i) 30 trading days following the date of our initial public announcement of topline data from its Phase 3 ENSURE trials (for the avoidance of doubt, the later date of the initial public announcement of topline data from ENSURE-1 or ENSURE-2, if announced separately) (the “Topline Data Announcement”), (ii) immediately upon the exercise of the February 2026 Pre-Funded Warrants if such exercise of February 2026 Pre-Funded Warrants is prior to the Topline Data Announcement, provided that if the February 2026 Pre-Funded Warrant is not exercised in full, the February 2026 Common Warrant expires proportionally only to the extent the Pre-Funded Warrant is exercised, and (iii) February 17, 2031.
The aggregate gross proceeds to the Company from the issuance and sale of the February 2026 Warrants was approximately $200 million, before deducting fees to be paid to the placement agents and financial advisors of the Company and other estimated offering expenses payable by the Company. The aggregate exercise price of the February 2026 Warrants is approximately $200 million.
Leerink Partners LLC acted as lead placement agent for the Offering, Stifel, Guggenheim Securities, William Blair, LifeSci Capital, B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC also acted as placement agents for the February 2026 Offering. As compensation in connection with the February 2026 Offering, we agreed to pay the placement agents a fee equal to 6% of the aggregate gross proceeds received by us (i) upon the issuance of the February 2026 Warrants at closing and (ii) upon the cash exercise of the February 2026 Common Warrants.
We intend to use the net proceeds from the February 2026 Offering to fund our clinical trials and operations and for working capital and other general corporate purposes.
The securities issued in the February 2026 Offering have not been registered under the Securities Act, and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration. There is no established public trading market for the February 2026 Warrants, and we do not intend to list such securities on any national securities exchange or nationally recognized trading system.
In connection with the February 2026 Offering, we and each February 2026 Investor entered into a registration rights agreement simultaneously with the February 2026 Securities Purchase Agreement (the “February 2026 Registration Rights Agreement”). Pursuant to the February 2026 Registration Rights Agreement, as promptly as reasonably practicable following the February 2026 Closing Date but, in any event, not later than 45 days thereafter (the “Filing Date”) we shall file a resale registration statement on Form S-3 (or Form S-1 if Form S-3 is not available) providing for the resale by the Investors of the Registrable Securities (as defined in the February 2026 Registration Rights Agreement) and to use reasonable best efforts to cause such resale registration statement to be declared effective by the staff of the Securities and Exchange Commission (the “SEC”) at the earliest possible date but no later than the earlier of (a) the 60th calendar day following the Filing Date if the SEC notifies us that it will review the registration statement and (b) the fifth business day after we are notified by the SEC that the registration statement will not be “reviewed” or will not be subject to further review or (ii) the fifth business day following the receipt of Reverse Split Stockholder Approval (as defined below) and the consummation of the Reverse Stock Split.
The February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement contain certain representations and warranties, covenants and indemnities customary for similar transactions. The representations, warranties and covenants contained in the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement were made solely for the benefit of the parties to the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement, respectively, and may be subject to limitations agreed upon by the contracting parties.
Special Meeting and Reverse Stock Split
The February 2026 Securities Purchase Agreement provides that no later than three days following the February 2026 Closing Date, we must file a preliminary proxy statement with the SEC for the purpose of receiving stockholder approval (“Reverse Split Stockholder Approval”) of an amendment to our certificate of incorporation to effect a reverse stock split of the Company’s issued and outstanding Common Stock, at a ratio of not less than 10:1 (the “Reverse Stock Split”). The Company filed this proxy statement on February 20, 2026.
Royalty Purchase Agreement
As previously disclosed, on June 3, 2025, the Company issued series B common stock warrants to purchase up to an aggregate of 86,666,667 shares of Common Stock (or prefunded warrants to purchase shares of Common Stock) in an underwritten public offering (the “Series B Warrants”). On February 12, 2026, the Company entered into a purchase and sale agreement (the “Royalty Purchase Agreement”) with certain Series B Warrant holders who had purchased a predetermined number of Series B Warrants (each a “Participating Series B Holder”) and BVF Partners, L.P. (“BVF”), acting as royalty interest agent (the “Warrant Exchange”).
Pursuant to the Royalty Purchase Agreement, the Participating Series B Holders will exchange an aggregate of 51,087,000 Series B Warrants for a pro rata share of an aggregate 5% synthetic royalty on future sales of the Company’s vidofludimus calcium program in any country (the “Royalty Interests”). The pro rata share for each Participating Series B Holder is equal to the number of Series B Warrants exchanged by such Participating Series B Holder divided by the number of Series B Warrants exchanged by all Participating Series B Holders (expressed as a percentage). Royalty Interests will be due and payable quarterly by the Company to the Participating Series B Holders following the First Commercial Sale (as defined in the Royalty Purchase Agreement).
Pursuant to the Royalty Purchase Agreement, the Company has agreed to specified affirmative and negative covenants, including without limitation covenants regarding periodic reporting of information by the Company to the Participating Series B Holders, and audits of royalties paid under the Royalty Purchase Agreement. The Royalty Purchase Agreement also contains representations and warranties, other covenants, indemnification obligations, and other provisions customary for transactions of this nature.
On the Closing Date, Series B Warrants to purchase up to an aggregate of 51,087,000 shares of Common Stock were surrendered by Participating Series B Holders and cancelled, and Series B Warrants to purchase up to an aggregate of 35,579,667 shares of Common Stock remain issued and outstanding.
Changes to the Board of Directors – Appointment of Director
On February 12, 2026, our board of directors (the “Board”), following the recommendation of the Nominating and Corporate Governance Committee of the Board (the “Committee”), appointed Thor Nagel, an Analyst with BVF, to the Board until the 2026 annual meeting of stockholders as a Class III director or until his respective successors are duly elected and qualified.
Changes to the Board of Directors – Appointment of Chair
On February 12, 2026, following the recommendation of the Committee, the Board appointed Simona Skerjanec, a member of the Board since July 2024, to serve as Interim Chairperson of the Board. Dr. Duane Nash, former Chairman, remains a member of the Board.
Changes to the Board of Directors – Resignation of Director
On February 12, 2026, Maria Törnsén resigned as a member of the Board in connection with the February Offering. The resignation of Ms. Törnsén was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices. The Board and the Company are deeply grateful for Ms. Törnsén’s service, dedication, and contributions to the Company.
CEO Search
Our Co-Founder and Chief Executive Officer, Dr. Daniel Vitt, and the Board will begin a search for a new CEO with deep commercial expertise in the MS space to lead Immunic through its next stage of growth and into commercialization. Subsequently, Dr. Vitt plans to transition to a new senior executive role focused on strengthening the company's scientific strategy and driving portfolio advancement. He will continue to support the organization in this capacity and as a member of the Board of Directors.
Private Placement of up to $240 Million (The "January 2024 Offering")
On January 4, 2024, Immunic entered into a Securities Purchase Agreement with select accredited and institutional investors, pursuant to which the Company agreed to issue and sell to the Investors in a three-tranche private placement shares of the Company’s common stock, $0.0001 par value per share or in lieu thereof, pre-funded warrants to purchase shares of Common Stock. The Pre-Funded Warrants are exercisable immediately for $0.0001 per share and until exercised in full.
•The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $80 million of Common Stock (or Pre-Funded Warrants) from the Company at a price of $1.43 per share;
•The second tranche is a conditional mandatory purchase by the Investors of an additional $80 million of Common Stock (or Pre-Funded Warrants) from the Company at a price of $1.716 per share, equal to 120% of the price paid in the first tranche and is subject to the satisfaction of three conditions:
◦release by the Company of topline data from its Phase 2b clinical trial of vidofludimus calcium (IMU-838) in progressive multiple sclerosis, which data is currently expected in or around April 2025;
◦the 10-day volume-weighted average price of the Common Stock is at least $8.00 per share during the 6 months following the data release; and ◦aggregate trading volume during the same 10-day period is at least $100 million.
•The third tranche must occur no later than three years after the second tranche and is conditioned on the same volume-weighted average share price and minimum trading volumes as the second tranche. The third tranche provides for the issuance of $80 million of shares of common stock (or pre-funded warrants) at the same price per share as the second tranche, but permits investors to fund their purchase obligations on a “cashless” or net settlement basis, which would reduce the cash proceeds to be raised by the Company in the January 2024 Financing.
Any of the conditions in the second or third tranches can be waived by holders of a majority of the outstanding securities (including the lead Investor).
The Janaury 2024 Financing resulted in gross proceeds to the Company of approximately $80 million in the first tranche, and an additional $80 million if and when the second tranche occurs. Assuming that the second tranche is completed and conditions for the third tranche are satisfied or waived, the Company could receive up to an additional $80 million in the third tranche. However, the amount of cash received in the third tranche would depend on the extent to which the Investors elect to fund the third tranche through a “cashless” or net settlement basis. Therefore, total gross proceeds from the offering to the Company could actually be between $80 million and $240 million. Gross proceeds to the Company will be reduced by fees paid to the placement agents, capital markets advisors and payments of transaction expenses. The Company intends to use the net proceeds from the Private Placement to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-856 and IMU-381, and for other general corporate purposes.
Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States
On March 20, 2024, we announced Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for patent application 16/981,122, entitled, “Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents,” covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. The claims are expected to provide protection into 2041, unless extended further. The patent was previously granted to the Company in Australia, Canada, Indonesia, Japan and Mexico.
Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS in the Peer Reviewed Journal, Neurology® Neuroimmunology & Neuroinflammation
On April 30, 2024, we announced that data from our Phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS has been published online on April 25, 2024 in Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology. The paper, lead authored by coordinating investigator, Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, is entitled, “Safety and Dose-Response of Vidofludimus Calcium in Relapsing Multiple Sclerosis: Extended Results of a Placebo-Controlled Phase 2 Trial.”
Appointment of Jason Tardio as Chief Operating Officer and President and Promotion of Werner Gladdines to Chief Development Officer
On July 9, 2024, we announced that seasoned biopharmaceutical executive, Jason Tardio, will be joining the company as Chief Operating Officer and President, effective July 12, 2024. In the newly created role, Mr. Tardio leads internal efforts to prepare for the potential launch of vidofludimus calcium. Jason also works closely with Patrick Walsh, Chief Business Officer, to prepare the Company for a range of potential partnership outcomes for vidofludimus calcium, as well as our other drug candidates.
On July 9, 2024, we also reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, has been promoted to Chief Development Officer. In his new role, Mr. Gladdines takes over additional strategic and operational responsibility for our overall clinical operations functions.
Appointment of Simona Skerjanec to Board of Directors
On July 24, 2024, we announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience in drug development and commercialization, as a member of our Board of Directors, effective as of July 22, 2024. As a Class I director, Ms. Skerjanec’s term lasts until the Company’s 2027 annual meeting of stockholders.
FirstPresented Patient Enrolled in Investigator-SponsoredAdditional Phase 2 ClinicalCALLIPER Trial ofData for Vidofludimus Calcium inat Patientsthe withACTRIMS PostForum COVID Syndrome2026
On February 4, 2026, we announced the presentation of additional data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the Americas Committee for Treatment and Research in Multiple Sclerosis (“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 our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.
On September 4, 2024, we announced enrollment of the first patient in an investigator-sponsored Phase 2 clinical trial of vidofludimus calcium, entitled, “Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE).” The Phase 2 RAPID_REVIVE trial, for which Immunic is providing study medication, is a randomized, placebo-controlled, double-blind, parallel group trial sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research.
Hosted Two Multiple Sclerosis R&D Days in New York City and San Francisco
At two MS R&D Days, on September 10, 2024 in New York City and on April 9, 2024 in San Francisco, management discussed the latest developments in the MS landscape, along with recent mode of action, preclinical and clinical data supporting the combined neuroprotective, anti-inflammatory and antiviral profile of vidofludimus calcium.
Presented Key Vidofludimus Calcium Data at the 40th41st Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple SclerosisMS
On September 24, 2025, we announced presentations of key vidofludimus calcium data at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (“ECTRIMS”). The results from our Phase 2 CALLIPER trial in PMS, also selected for the Best of ECTRIMS 2025 slide deck, highlighted vidofludimus calcium's neuroprotective potential and its promise to slow disease progression in patients with or without focal inflammation. Importantly, the consistent 24-week confirmed disability worsening (“24wCDW”) results across patient populations and subgroups, including in patients without evidence of baseline inflammatory gadolinium-enhancing (“Gd+”) lesions during MRI, were seen both in the overall population and in the primary progressive multiple sclerosis (“PPMS”) and non-active secondary progressive multiple sclerosis (“naSPMS”) subgroups. Additionally, data regarding 24-week confirmed disability improvement (“24wCDI”) showed an over two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across the subtypes. The CALLIPER findings support our hypothesis of clinically measurable neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism. We believe that, since 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS, this evidence of clinical activity merits further investigation and de-risks a potential Phase 3 program.
Moreover, at ECTRIMS, we also presented additional long-term data from the open-label extension (“OLE”) period of our Phase 2 EMPhASIS trial in RRMS which further reinforced the robust efficacy signals and favorable safety and tolerability observed, to date. The long-term EMPhASIS OLE data demonstrated that vidofludimus calcium was well-tolerated in patients with RRMS for treatment durations of up to 5.5 years. Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled approximately 952 treatment years, with an annualized discontinuation rate of only approximately 6.4%. The most common treatment-emergent adverse events were mild, with low rates of renal and liver-related events and no new safety signals observed. Serious adverse events were infrequent and none were deemed related to treatment. These results suggest a favorable long-term safety and tolerability profile for vidofludimus calcium in RRMS.
Received Notice of Allowance from the United States Patent and Trademark Office Protecting Vidofludimus Calcium's Dose Strengths in PMS
On September 9, 2025, we announced that we received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for patent application 18/529,946, entitled "Treatment of multiple sclerosis comprising DHODH inhibitors." Specifically, the resulting patent covers dose strengths associated with vidofludimus calcium and other salt forms as well as free acid forms, at a daily dose of about 10 mg to 45 mg, for the treatment of PMS, including the sub-groups PPMS and secondary progressive multiple sclerosis (“SPMS”). The patent is expected to provide protection into 2041, and a potential Patent Term Extension may offer additional market exclusivity in the United States. Allowance of this new key patent represents a significant advancement for vidofludimus calcium program in PMS and further strengthens its robust, multi-layered intellectual property portfolio.
On September 18, 2024, we announced the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (“ECTRIMS”), highlighting vidofludimus calcium’s therapeutic potential in MS. The data was presented in an oral poster presentation and three ePosters at this conference in Copenhagen, Denmark.
New, Positive OutcomeLong-Term ofOpen-Label InterimExtension AnalysisData offrom Phase 32 ENSUREEMPhASIS ProgramTrial of Vidofludimus Calcium in Relapsing Multiple SclerosisRRMS
On June 24, 2025, we announced new long-term OLE data from our Phase 2 EMPhASIS trial in patients with RRMS. The data at week 144 showed that 92.3% of patients remained free of 12w CDW, and 92.7% free of 24w CDW. A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144. Of these, 44.8% were associated with relapse-associated worsening (“RAW”), while only 13.8% were associated with progression independent of relapse activity (“PIRA”). Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforces the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of treatment-emergent and serious adverse events. Importantly, no new safety signals have emerged during treatment durations up to 5.5 years.
The Phase 2 EMPhASIS trial in RRMS includes an optional OLE period for up to 9.5 years to evaluate long-term safety and tolerability of vidofludimus calcium. Of the 268 patients that started the double-blind main treatment period, 254 patients continued in the OLE period. At the time of data cutoff on January 14, 2025, 182 patients (71.6% of patients starting OLE) were evaluated up to week 144, which translates into approximately 952 overall treatment years.
Completion of Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in RMS
On June 5, 2025, we announced completion of enrollment for both Phase 3 ENSURE trials. The ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa (“MENA”) region, Latin America, and Central and Eastern Europe. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo. The primary endpoint for both trials is time to first relapse up to 72 weeks. Secondary endpoints include time to confirmed disability worsening based on the expanded disability status scale ("EDSS"), volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and MRI-based endpoints. The top-line data from both ENSURE trials is expected by the end of 2026, which should allow for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint.
What changed in the latest 10-Q
Risk Factors
You should carefully consider the risk factors included in Item 1A. of the 2025 Annual Report and the other information in this Quarterly Report, including the section of this Quarterly Report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes. If any of the events described in our 2025 Annual Report, and elsewhere in this Quarterly Report occur, our business, operating results and financial condition could be seriously harmed. This Quarterly Report also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of factors that are described in our 2025 Annual Report and elsewhere in this Quarterly Report.
No wording changes found in this section.
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Management's Discussion & Analysis (MD&A)
New heading “Financial Condition, Liquidity and Going Concern”
New heading “Appointment of Michael W. Bonney as Chair of the Board of Directors”
New heading “Appointment of Erik Lundgren as Chief Executive Officer”
New heading “Resignation of Dr. Daniel Vitt”
New heading “Presented Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive MS”
New heading “2026 Annual Meeting of Stockholders”
New heading “Resignation of Tamar Howson from the Board of Directors; Appointment of Erik Lundgren to the Board of Directors”
New heading “Appointment of Elena Ridloff as a Director”
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
New heading “Financial Condition, Liquidity and Going Concern”
Removed heading “Liquidity and Financial Condition”
Removed heading “Liquidity and Financial Condition”
Removed heading “Contractual Obligations”
Removed heading “Royalty Payable”
Largest changes
“Financial Condition, Liquidity and Going Concern”see in full comparison
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“On August 7, 2026, the Company entered into a Separation Agreement with Dr. Daniel Vitt, pursuant to which Dr. Vitt's employment with the Company and its wholly owned subsidiary, Immunic AG, terminated on August 7, 2026 (the “Separation Date”). His resignation was not the result of any disagreement with the Company on any matter relating to its operations, policies, or practices. Commencing on the Separation Date, Dr. …”see in full comparison
“Presented Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive MS”see in full comparison
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The inclusion of any forward-looking statements in this Quarterly Report should not be regarded as a representation that any of our plans will be achieved. Our actual results may differ from those anticipated in our forward-looking statements as a result of various factors, including those noted below under the caption “Part II, Item 1A-Risk Factors,” and the risk factors described in our most recent Annual Report on Form 10-K filed with the SEC (the "2025 Annual Report"), and the differences may be material. These risk factors include, but are not limited to statements relating to our development programs and the targeted diseases; the potential for vidofludimus calciumcalcium, IMU-381 and IMU-856 to safely and effectively target diseases; the nature, strategy and focus of the Company; expectations regarding our capitalization and financial resources; the development, timing and commercial potential of any product candidates of the CompanyCompany, including the timing of any new drug application submission and regulatory approval; our anticipated commercialization strategy and expectations regarding the size of the market opportunities for our product candidates; the impact of government laws, regulations and tariffs; and our ability to attract and retain certain personnel important to our ongoing operations and to maintain effective internal control over financial reporting.
Immunic, Inc. (“Immunic," “we,” “us,” “our” or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. We are headquartered in New York City with our research and development operations in Gräfelfing near Munich, Germany. We had approximately 95100 employees as of AprilJuly 30,31, 2026. We believe our lead candidate, vidofludimus calcium, positions us to pivot toward becoming a fully integrated commercial-stage multiple sclerosis (“MS”) company, and we are building the commercial, regulatory and organizational capabilities to support a potential launch in relapsing MS, while continuing to advance our pipeline in progressive MS and other neurologic indications.
We are pursuingfocused clinicalon development and potential commercialization of orally administered, small molecule programs,programs each of which haswith unique features intended to directly address the unmet needs of patients with serious chronic inflammatoryneurologic and autoimmune diseases. These include theThe vidofludimus calcium (IMU-838) program, whichprogram is in Phase 3 clinical development for patients with relapsing multipleMS, sclerosiswith (“RMS”),an andadditional whichPhase 3 clinical trial in progressive MS planned to be initiated. It has previously shown therapeutic activity in Phase 2 clinical trials in patients suffering fromwith relapsing-remitting multiple sclerosis ("RRMS"),MS, progressive multiple sclerosis (”PMS”)MS, and other diseases;diseases. theOur IMU-856development program,pipeline whichalso isincludes targetedearlier-stage toprograms, regenerateincluding bowel epitheliumIMU-381 and restoreIMU-856, intestinalaimed barrierat function,building whicha couldbroader potentiallytherapeutics beplatform applicableaddressing in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease (“IBD”),neurodegenerative and Graft-versus-Host-Disease ("GvHD"); and the IMU-381 program, which comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging our nuclear receptor-related 1 (“Nurr1”) platform.diseases.
The following table summarizes the potential indications, clinical targets and clinical development status of our three product candidates:
Our mostlead advanced drugdevelopment candidate, vidofludimus calcium (IMU-838), is being tested in ongoing multiple sclerosis (“MS”) trials as part of its overall clinical development program in order to support potential regulatory approvals for patients with MS in major markets.
The Phase 3 ENSURE program of vidofludimus calcium in RMS,relapsing MS, comprising twin studies evaluating efficacy, safety, and tolerability of vidofludimus calcium versus placebo, is currently ongoing. In October 2024, we announced a positive outcome of an interim analysis of the ENSURE program, with an unblinded Independent Data Monitoring Committee ("IDMC") confirming that the predetermined futility criteria have not been met and recommending that both ENSURE trials should continue without changes, including no need for a potential increase of the sample size. In June 2025, we announced completion of enrollment for both ENSURE trials. Each of the trials enrolled adult patients with active RMSrelapsing MS at more than 100 sites in 15 countries. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either a 30 mg daily dosesdose of vidofludimus calcium or placebo. The top-line data for both ENSURE trials is expected by the end of 2026. Although we currently believe that this goal is achievable, it is dependent on numerous factors, most of which are not under our direct control and can be difficult to predict. We plan to periodically review this assessment and provide updates of material changes as appropriate. If the ENSURE trials are positive, we intend to target submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration in mid-2027, with potential U.S. regulatory approval in 2028.
Our Phase 2 CALLIPER trial of vidofludimus calcium in PMSprogressive MS was designed to corroborate vidofludimus calcium’s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of PMSprogressive MS patients to determine the suitability of advancing to a confirmatory Phase 3 program. In 2025, we announced the results from the CALLIPER trial,trial. showingEven though the primary percent brain volume change (“PBVC”) endpoint was not met, exploratory imaging and clinical outcomes revealed consistent, directionally favorable signals. The data showed substantial and medically relevant numerical reductions in 24-week confirmed disability worsening (“24wCDW”) across patient populations and subgroups without evidence of focal inflammation; substantialconsistent andincreases statistically significant data regardingin 24-week confirmed disability improvement (“24wCDI”); andas well as reductions in the annualized rate of thalamic brain volume loss andloss, volume of new or enlarging T2 lesions.lesions and slowly expanding lesions (“SEL”) count over time. The CALLIPER data also confirmed the favorable safety and tolerability profile of vidofludimus calciumcalcium, similar to placebo, as already observed in previous clinical trials. Initiation of a Phase 3 clinical trial of vidofludimus calcium in progressive MS is expected later in 2026.
If approved, we believe that vidofludimus calcium, with combined neuroprotective, anti-inflammatory, and antiviral effects as well as a favorable safety and tolerability profile, has the potential to be a unique treatment option targeted to the complex pathophysiology of MS. Preclinical data showed that vidofludimus calcium activates the neuroprotective transcription factor Nurr1,nuclear receptor-related 1 (“Nurr1”), which is associated with direct neuroprotective effects and may enhance the potential benefit for patients. Additionally, vidofludimus calcium is a selective inhibitor of the enzyme dihydroorotate dehydrogenase (“DHODH”), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and antiviral effects of vidofludimus calcium. We believe that the combined mechanisms of vidofludimus calcium are unique in the MS space and support the therapeutic performance observed in our Phase 2 EMPhASIS trial in RRMSrelapsing-remitting MS patients and in our Phase 2 CALLIPER trial in PMSprogressive MS patients. Vidofludimus calcium has shown a consistent pharmacokinetic, safety and tolerability profile in clinical trials reported,profile, to date,date. andOver has3,500 alreadyparticipants have been exposed to vidofludimus in completed and ongoing clinical trials, with a maximum continuous exposure of more than 3,4006.5 human subjects and patients in either of the drug’s formulations.years.
IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (“SIRT6”), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, we believe this compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, IBD, GvHD and other intestinal barrier function associated diseases. Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance for patients during therapy, which would be an important advantage versus immunosuppressive medications and may allow the potential for combination with available treatments in multiple gastroenterological diseases.
Data from a Phase 1b clinical trial in celiac disease patients during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. In a post hoc analysis of this Phase 1b clinical trial, IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (“GLP-1”) levels. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing.
We are currently exploring strategic alternatives for the IMU-856 program and are open to discussing potential financing, licensing or partnering options with interested parties.
We have selected the IMU-381 program to leverage our Nurr1 platform for neurologic, gastrointestinalneurologic and other autoimmune diseases. The platform comprises next-generation molecules, including a series of chemical derivatives, with improved overall properties. The IMU-381 program is currently in preclinical testing.
IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (“SIRT6”), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, we believe this compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, IBD, GvHD and other intestinal barrier function associated diseases. We are currently exploring strategic alternatives for the IMU-856 program and are open to discussing potential financing, licensing or partnering options with interested parties.
Additional research and development activities remain ongoing through preclinical research examining the potential to treat a broad set of neuroinflammatory, autoimmune,neurologic and viralautoimmune diseases with new molecules leveraging our chemical and pharmacological research platform as well as generating intellectual property in these areas. We are also exploring several options to possibly support further development of certain assets and technologies, including a potential spin-off into a new company and potential licensing transactions. Through our wholly-owned subsidiary Gliomic Therapeutics Inc., we are pursuing the use of new compounds in brain cancers leveraging our expertise in DHODH inhibition.
We expect to continue to lead most of our research and development activities from our Gräfelfing, Germany location, where dedicated scientific, regulatory, clinical and medical teams conduct their activities. Due to these teams' key relationships with local and international service providers and academic partners, we anticipate that this should result in more timely and cost-effective execution of our development programs. In addition, we are using our subsidiary in Melbourne, Australia to perform research and development activities in the Australasia region. We also conduct preclinical work in our laboratory in Martinsried, Germany and in Halle/Saale, GermanyGermany, and through a collaboration with the Fraunhofer Institute.Institute in Halle/Saale, Germany.
Our business, operating results, financial condition and growth prospects are subject to significant risks and uncertainties, including delays in clinical trials, the failure of our clinical trials to meet their endpoints, failure to obtain regulatory approval and failure to obtain needed additional funding on acceptable terms, if at all, to complete the development and commercialization of our three development programs.
We are focused on the development and potential commercialization of new molecules that maximize the therapeutic benefits for patients by uniquely addressing biologically relevant immunological targets. We take advantage of our established research and development infrastructure and operations in Germany and Australia to more efficiently develop our product candidates in indications of high unmet need and where the product candidates have the potential to elevate the standard of care for the benefit of patients. Given the mechanisms of action and the data generated for our product candidates, to date, we continue to execute on the clinical development of our programs for established indications as well as explore additional indications where patients could potentially benefit from the unique profiles of each product candidate.
•Executing and completing the ongoing twin Phase 3 ENSURE clinical trials of vidofludimus calcium in RMS.relapsing MS. If positive, preparation for NDA filing in the United States and potential commercialization.
•Preparation ofInitiating a Phase 3 clinical program of vidofludimus calcium in primary progressive MS, following the successful completion of the Phase 2 CALLIPER clinical trial in PMS and feedback from healthcare authorities.
•Facilitating pre-commercial readiness for potential commercial launch of our product candidates, if regulatory approvals are received, through targeted and stage-appropriate pre-commercial activities.
•Leveraging our preclinical Nurr1 platform for neurologic and autoimmune diseases.
Financial Condition, Liquidity and Going Concern
•Facilitating readiness for potential commercial launch of our product candidates, if regulatory approvals are received, through targeted and stage-appropriate pre-commercial activities.
•Evaluating potential strategic collaborations for each product candidate in order to complement our existing research and development capabilities and to facilitate potential commercialization of these product candidates by taking advantage of the resources and capabilities of strategic collaborators in order to enhance the potential and value of each product candidate.
Liquidity and Financial Condition
ImmunicWe hashave no products approved for commercial sale and hashave not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. TheWe Company hashave an accumulated deficit of approximately $641.2$675.3 million as of MarchJune 31,30, 2026 and $608.6 million as of December 31, 2025. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we initiate and continue the development of our product candidates and add personnel necessary to advance our pipeline of product candidates. We expect that our operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of development programs.
From inception through MarchJune 31,30, 2026, thewe Companyhave raised net cash of approximately $684.9 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights. As of MarchJune 31,30, 2026, we had cash and cash equivalents of approximately $186.6$155.1 million. With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.
On April 14, 2026, we held a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, our stockholders voted to authorize our Board of Directors,Directors ("the "Board"), in its discretion, to amend our certificate of incorporation, as amended and restated, to effect a reverse stock split of all of the outstanding shares of the Common Stock, at a ratio in the range of 1-for-10 to 1-for-30, with such ratio to be determined by the Board. Following the Special Meeting, the Board approved a reverse stock split of our issued and outstanding Common Stock, at a ratio of 1-for-10 shares, which became effective April 27, 2026 (the “Reverse Stock Split”). All share amounts in this document have been adjusted retroactively to reflect the reverse stock split.
On February 12, 2026, our Board of Directors (the “Board”),Board, following the recommendation of the Nominating and Corporate Governance Committee of the Board (the “Committee”), appointed Thor Nagel, an Analyst with BVF, to the Board until the 2026 annual meeting of stockholders as a Class III director or until his respective successors are duly elected and qualified.
On February 4, 2026, we announced the presentation of additional data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive MS at the Americas Committee for Treatment and Research in Multiple Sclerosis (“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 our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.
On March 10, 2026, we announced that the European Patent Office (“EPO”) has granted a key European patent, EP3713554, directed to label-relevant dosing regimens of vidofludimus calcium. The patent is expected to provide protection for vidofludimus calcium in Europe into 2038, and may be eligible for a Supplementary Protection Certificate ("SPC"), which could extend market exclusivity potentially into 2043. This patent was previously granted by the United States Patent and Trademark Office ("USPTO") in 2023.
On March 31, 2026, we announced the appointment of Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to our Board, effective March 27, 2026. In connection with his appointment as a director, Mr. Congleton received an inaugural grant of options to purchase up to a total of 50,000 shares of the Company’s common stock, effective March 27, 2026, which vest on a monthly basis over a three-year period.
CEO Search
Our Co-Founder and Chief Executive Officer, Dr. Daniel Vitt, and the Board have begun a search for a new CEO with deep commercial expertise in the MS space to lead Immunic through its next stage of growth and into commercialization. Subsequently, Dr. Vitt plans to transition to a new senior executive role focused on strengthening the Company's scientific strategy and driving portfolio advancement. He will continue to support the organization in this capacity and as a member of the Board of Directors.
On March 31,2026, we announced the appointment of Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to our Board of Directors, effective March 27, 2026. In connection with his appointment as a director, Mr. Congleton received an inaugural grant of options to purchase up to a total of 50,000 shares of the Company’s common stock, effective March 27, 2026, which vest on a monthly basis over a three-year period.
On March 10, 2026, we announced that the European Patent Office (“EPO”) has granted a key European patent, EP3713554, directed to label-relevant dosing regimens of vidofludimus calcium. The patent is expected to provide protection for vidofludimus calcium in Europe into 2038, and may be eligible for a Supplementary Protection Certificate (SPC), which could extend market exclusivity potentially into 2043. This patent was previously granted by the United States Patent and Trademark Office (USPTO) in 2023.
On February 4, 2026, we announced the presentation of additional data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the Americas Committee for Treatment and Research in Multiple Sclerosis (“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 our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.
Pursuant to the Agreement, subject to Dr. Vitt's continued employment with the Company through theAugust ninety-first31, (91st) day after a new Chief Executive Officer is hired by the Company,2026, Dr. Vitt shall be entitled to receive a retention bonus equal to $670,000, less applicable withholdings and payroll deductions. The Retention Bonus will be paid in one lump sum on the first regularly scheduled pay date after the Retention Date, subject to the terms and conditions of the Agreement.
Effective April 24, 2026, Michael A. Panzara, M.D., M.P.H., was appointed as our Chief Medical Officer. Dr. Panzara will lead our development organization, including clinical development, medical affairs, and regulatory affairs, and will be a critical partner to the Chief Executive Officer and the Board of Directors in defining and driving the overall company strategy. Dr. Panzara brings over 25 years of global neurology experience to Immunic. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A.
Commencing on the Separation Date, Dr. Muehler will serve as a consultant to the Company for an initial period of ten (10) months, providing consulting services on an as-needed basis for up to twenty (20) hours per month, in exchange for a monthly retainer of $10,000. In addition, the Company agreed to provide Dr. Muehler with severance benefits, including a lump sum payment equal to twelve (12) months of Dr. Muehler’s base salary, a pro-rated bonus for fiscal 2026, provided that such bonus will be determined by the Company in the ordinary course and will be paid (to the extent determined to have been earned by the Company) when such bonus is paid to employees of the Company, and a lump sum payment from Immunic AG equal to twelve (12) months of Dr. Muehler’s fixed annual salary under the Service Agreement, subject to Dr. Muehler’s execution of a release of claims in favor of the Company and compliance with the terms of the Separation Agreement. Additionally, 100% of Dr. Muehler’s outstanding equity awards vested as of the Separation Date. Dr. Muehler will have three (3) years following Separation Date to exercise any vested equity awardsawards.
Appointment of Michael W. Bonney as Chair of the Board of Directors
On May 16, 2026, our Board appointed Michael W. Bonney, a highly experienced biopharmaceutical executive and board leader, as Chair of our Board, effective immediately.
In connection with his appointment as a director, Mr. Bonney received an inaugural grant of options to purchase up to a total of 100,000 shares of the Company’s common stock, effective May 16, 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 May 15, 2026 (the “Award”). The Award is subject to the approval by the Company’s shareholders of an increase to the number of shares reserved for issuance under the Company’s 2019 Omnibus Equity Incentive Plan which occurred on June 29, 2026. Mr. Bonney will also receive cash compensation for his 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.
In connection with Mr. Bonney’s appointment as Chair of the Board, Simona Skerjanec, who has been serving as Interim Chairperson since February 2026, transitioned from Interim Chairperson and continue to serve as a member of the Board.
Appointment of Erik Lundgren as Chief Executive Officer
On May 27, 2026, we announced the appointment of distinguished biopharmaceutical executive Erik Lundgren as Chief Executive Officer, effective May 22, 2026, with employment beginning on June 1, 2026. Mr. Lundgren succeeded Daniel Vitt, Ph.D.
Mr. Lundgren will lead Immunic as we advance vidofludimus calcium through late-stage clinical development, including the pivotal Phase 3 ENSURE program in relapsing MS and the planned Phase 3 program in progressive MS, while also preparing for potential NDA filing, regulatory approval and commercialization.
Resignation of Dr. Daniel Vitt
On May 22, 2026, Daniel Vitt, resigned as the Chief Executive Officer of the Company, effective June 1, 2026. 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.
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.
On August 7, 2026, the Company entered into a Separation Agreement with Dr. Daniel Vitt, pursuant to which Dr. Vitt's employment with the Company and its wholly owned subsidiary, Immunic AG, terminated on August 7, 2026 (the “Separation Date”). His resignation was not the result of any disagreement with the Company on any matter relating to its operations, policies, or practices. 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.
Presented Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive MS
On May 28, 2026, we announced the presentation of one late-breaking and two additional posters highlighting additional data from our Phase 2 CALLIPER trial at the 2026 Consortium of Multiple Sclerosis Centers (“CMSC”) Annual Meeting. A late-breaking analysis introduced a new and potentially more comprehensive way to measure overall disability change by capturing both slowing of progression and improvement of disease. Together with supportive safety, tolerability and patient-reported data, these findings further strengthen our confidence in the potential of vidofludimus calcium to address key drivers of MS disease progression.
2026 Annual Meeting of Stockholders
On June 29, 2026, we held our 2026 Annual Meeting of Stockholders, at which our stockholders approved, among other things, an amendment to our 2019 Omnibus Equity Incentive Plan to increase the number of authorized shares by 6,000,000 shares, as further described in Note 7.
Resignation of Tamar Howson from the Board of Directors; Appointment of Erik Lundgren to the Board of Directors
On June 29, 2026, Tamar Howson resigned as a member of the Compensation Committee of the Board, and as a member of the Board, as Ms. Howson transitions into retirement. Ms. Howson’s resignation was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices. The Board and the Company are deeply grateful for Ms. Howson’s service, dedication, and contributions to the Company.
In connection with Ms. Howson’s resignation, on July 5, 2026, following the recommendation of the Nominating and Corporate Governance Committee of the Board, the Board appointed Erik Lundgren, the Company’s Chief Executive Officer, to serve as a Class II director of the Board until the 2028 annual meeting of stockholders and until his successor is duly elected and qualified, or until his earlier death, resignation or removal. Mr. Lundgren has not been appointed to serve on any committee of the Board. Mr. Lundgren will not receive any additional compensation for his service as a director.
Appointment of Elena Ridloff as a Director
IMUX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding IMUX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 740,347 | $11.4M | 0.01% | New position |
| Millennium Management (Israel Englander) | 2026-06-30 | 3,779,922 | $4.2M | — | Sold out |
| Renaissance Technologies | 2026-06-30 | 919,164 | $1.0M | — | Sold out |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 21,620 | $332.3K | 0.0% | New position |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 10,806 | $166.1K | 0.0% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 114,487 | $127.1K | — | Sold out |
| Two Sigma Investments | 2026-06-30 | 67,186 | $74.6K | — | Sold out |