Immunic Inc (IMUX)

Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive Multiple SclerosisMay 28, 2026 6:30 AM
PR Newswire (US) – Late-Breaking Poster Introduces New Unified Statistical Analyses for Assessing Confirmed Disability Changes for Trials in Progressive Multiple Sclerosis –– Additional CALLIPER Data Further Highlight Vidofludimus Calcium's Favorable Safety and Tolerability Profile; Patient-Reported Outcomes Assessments Show No Negative Impact on Mood –NEW YORK, May 28, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the presentation of one late-breaking and two additional posters highlighting additional data from its phase 2 CALLIPER trial evaluating lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS) at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, taking place May 27-29, 2026 in Charlotte, NC. All poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, Immunic team members will be available throughout the meeting at booth #307."We believe the new data presented in these three posters at the prestigious CMSC Annual Meeting continues to demonstrate a consistent and differentiated profile for vidofludimus calcium in multiple sclerosis (MS)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The late-breaking analysis is particularly interesting, as it introduces 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.""These post-hoc analyses from the phase 2 CALLIPER trial provide valuable insights as to the effects of vidofludimus calcium in patients with progressive MS," added Michael A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. "Whereas disability in MS is commonly measured by 3- or 6-months confirmed disability worsening, our late-breaking poster presents a novel approach capturing both worsening and improvement on treatment, allowing for a more comprehensive assessment of well-being. In applying these assessments, we observed favorable effects of vidofludimus calcium versus placebo. These data, combined with a safety and tolerability profile that appears favorable, supports the continued development of vidofludimus calcium for progressive MS."Late-Breaking Poster Presentation Details:Poster Title: Novel Unified Statistical Analyses for Confirmed Disability Changes in Multiple Sclerosis for Capturing Possible Neuroprotective EffectsPresenting Author: James Myles, Global Head of Biostatistics at ImmunicAbstract ID: 11244Poster Board Label: LBA14Session Date: Thursday, May 28, 2026Session Time: 5:00-7:00 pm ETLocation: Exhibit HallThis late-breaking poster introduces a novel unified endpoint, Confirmed Disability Change (CDC), designed to capture both confirmed disability worsening (CDW) and confirmed disability improvement (CDI) within a single statistical framework. Three complementary statistical approaches, including ordinal categorical analysis, time-to-event modeling and Markov state change modeling, were applied post-hoc to data from the phase 2 CALLIPER trial in PMS. Across these models, results consistently favored vidofludimus calcium over placebo.These findings suggest that the CDC approach may provide a more complete view of disability trajectories in PMS than conventional one-direction analyses, particularly for evaluating possible neuroprotective effects. Broader adoption of such an integrated endpoint may improve statistical power in future clinical trials and help better capture treatment benefits for patients with PMS.Poster Presentation Details:Poster Title: Effect of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor, on Patient-Reported Outcomes (PRO) in Progressive MS: Data from Phase 2 CALLIPER TrialPresenting Author: Julie Korich, Ph.D., Senior Medical Director, Medical Affairs at ImmunicAbstract ID: 10843Poster Board Label: DMT10Session Date: Thursday, May 28, 2026Session Time: 5:00-7:00 pm ETLocation: Exhibit Hall BThis poster presents patient-reported outcomes from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, including measures of severity of depressive thoughts (Patient Health Questionnaire-9, PHQ-9) and overall treatment satisfaction (Treatment Satisfaction Questionnaire for Medication), collected over the treatment period of up to 120 weeks.Analyses using a mixed model repeated measures (MMRM) approach showed that changes in PHQ-9 scores were similar between vidofludimus calcium and placebo across all assessed timepoints, including weeks 48, 72 and 120. At week 48, PHQ-9 scores numerically improved in both groups (vidofludimus calcium: -0.786 vs. placebo: -0.347), with a similar pattern observed at week 72 (vidofludimus calcium:
-0.568 vs. placebo: -0.609) and week 120 (vidofludimus calcium: -1.777 vs. placebo: -0.525). There was no indication of worsening depressive or suicidal thoughts with vidofludimus calcium (n=235) as compared to placebo (n=232) through 120 weeks.Patient-reported treatment effectiveness numerically favored vidofludimus calcium over placebo, particularly in perceived effectiveness at both week 48 (77.51 vs. 72.88) and week 120 (84.69 vs. 79.20), while side effect burden remained comparable between the treatment groups at both timepoints (97.65 vs. 97.70 at week 48 and 99.44 vs. 99.36 at week 120). Although exploratory in nature, these findings support a favorable patient-reported profile for vidofludimus calcium over two years.Presentation Details:Poster Title: Safety and Tolerability of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor: Data from Phase 2 CALLIPER TrialPresenting Author: Alex Lublin, Ph.D., Senior Medical Director, Medical Affairs at ImmunicAbstract ID: 10995Poster Board Label: DMT11Session Date: Thursday, May 28, 2026Session Time: 5:00-7:00 pm ETLocation: Exhibit Hall BThis poster provides an overview of safety and tolerability data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, based on 467 patients treated for up to 120 weeks.The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between vidofludimus calcium (69.4%) and placebo (68.5%). The most commonly reported events, including urinary tract infection, headache and back pain, occurred at similar or lower rates in the vidofludimus calcium arm compared to placebo. TEAEs leading to discontinuation were identical at 2.6% in both groups. Liver-related TEAEs were uncommon and similar between vidofludimus calcium and placebo (5.2% vs. 5.5%), with no cases meeting Hy's law criteria. Serious adverse events were observed at low and comparable rates between groups (8.1% vs. 6.5%). Rates of infections and infestations as well as renal or urinary events were also similar between groups.The collective data set shows a similar overall adverse events profile between vidofludimus calcium and placebo. These results are consistent with previous clinical experience and support the favorable safety and tolerability profile of vidofludimus calcium in patients with PMS.About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an orally administered investigational small molecule drug, currently in late-stage clinical trials for multiple sclerosis (MS). Vidofludimus calcium has a unique mode of action designed to combine neuroprotective, anti-inflammatory and anti-viral effects to address key biological drivers of MS. As a selective immune modulator, it activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which has been associated with direct and indirect neuroprotective effects. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which has been associated with anti-inflammatory and anti-viral effects. Vidofludimus calcium is currently being evaluated in the phase 3 ENSURE trials for the treatment of relapsing MS. In the phase 2 EMPhASIS trial, it showed therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. In the phase 2 CALLIPER trial in progressive MS patients, vidofludimus calcium showed promising clinical signals, including reductions in confirmed disability progression and statistically significant confirmed disability improvement. To date, more than 3,400 individuals have been exposed to vidofludimus calcium and it has shown a favorable pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country and its efficacy, safety and tolerability are still being evaluated in ongoing clinical trials.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomic trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-to-present-additional-phase-2-calliper-trial-data-for-vidofludimus-calcium-at-the-cmsc-annual-meeting-2026-reinforcing-its-potential-in-progressive-multiple-sclerosis-302784119.htmlSOURCE Immunic, Inc. Original: Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive Multiple Sclerosis

Immunic Appoints Distinguished Biopharmaceutical Executive Erik Lundgren as Chief Executive OfficerMay 27, 2026 6:30 AM
PR Newswire (US) – Proven Leader with Deep Multiple Sclerosis Expertise; Played Key Role in the Launch of Ocrevus® –– Will Leverage Senior Global Executive and Commercial Experience to Support Immunic's Transition Toward a Commercial-Stage Multiple Sclerosis Company –NEW YORK, May 27, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today 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 succeeds Daniel Vitt, Ph.D., who will retain responsibility for scientific strategy and portfolio advancement while remaining a member of Immunic's Board of Directors.Mr. Lundgren will lead Immunic as the company advances vidofludimus calcium through late-stage clinical development, including the pivotal phase 3 ENSURE program in relapsing multiple sclerosis (RMS) and the planned phase 3 program in primary progressive multiple sclerosis (PPMS), while also preparing for potential new drug application (NDA) filing, regulatory approval and commercialization."Immunic has evolved into a global late-stage biotechnology company built around its lead asset, vidofludimus calcium, which we believe represents one of the most compelling and differentiated opportunities in multiple sclerosis (MS) today," stated Michael W. Bonney, Chair of Immunic's Board of Directors. "As we look to our next phase of growth, including the pivotal phase 3 RMS data readout expected by year-end, preparations for NDA filing in this indication and potential commercialization thereafter, Erik's experience will be invaluable. I look forward to working with him as we continue transitioning Immunic toward a commercial-stage neurology company and deliver a potential next-generation treatment option for people living with MS.""I am truly honored to be joining Immunic at such an exciting and pivotal moment," stated Mr. Lundgren. "Over the past decade, the treatment landscape for MS has advanced meaningfully, broadening what is possible for people living with this complex disease. Yet a large unmet need remains, particularly for treatment options with the potential to slow disability progression and preserve neurological function. Vidofludimus calcium's potential to treat MS by targeting both immunological and neuroprotective pathways, along with a safety and tolerability profile that appears favorable to date, offers a differentiated approach within the MS therapeutic landscape, with the chance to impact both relapsing and progressive forms of the disease. Having spent my career focused on bringing innovative medicines to patients, including those with MS, I believe Immunic is uniquely positioned to advance this important program through late-stage development and potential commercialization. I look forward to working alongside the talented team at Immunic to help realize that vision.""Erik is highly accomplished and possesses the strategic, operational and commercial know-how needed to steer Immunic at this critical juncture," added Dr. Vitt. "His deep expertise in MS, including his role in helping shape the launch of Ocrevus®, combined with his long tenure and broad experience across Genentech and Roche, will be instrumental as we advance vidofludimus calcium through the pivotal phase 3 ENSURE readout in RMS and continue preparations for our planned phase 3 program in PPMS. As we approach these important milestones and continue our evolution toward becoming a commercial-stage biotechnology company, I am convinced that Erik is the right leader to guide Immunic into its next chapter. I look forward to continuing to support the company's scientific strategy and working alongside Erik and the Board to realize the full potential of our pipeline."Mr. Lundgren brings nearly two decades of biopharmaceutical experience spanning commercial strategy, product launches, global portfolio leadership, marketing and general management, with particular expertise in MS. He most recently served as Senior Vice President, Commercial Portfolio Organization at Genentech (a member of the Roche Group), where he led and oversaw the commercial strategy across all therapeutic areas of the company's broad portfolio. Prior to this role, he served as General Manager of Roche Czech Republic, where he led full operations and commercial strategy. Earlier, he served as Lifecycle Leader for Huntington's disease within Roche's neuroscience portfolio.Mr. Lundgren spent more than a decade at Genentech in roles of increasing responsibility, including serving as Senior Marketing Director supporting the launch and commercialization of Ocrevus® (ocrelizumab), a foundational treatment for RMS and PPMS and one of the most successful launches in neurology. He also held commercial leadership roles supporting the launches of oncology medicines, including Kadcyla® (ado-trastuzumab emtansine) and Zelboraf® (vemurafenib), and led various sales teams within Genentech's oncology franchise.Mr. Lundgren earned his Bachelor of Arts in Public Policy from Duke University and his Master of Business Administration from Harvard Business School.The Compensation Committee of Immunic's Board of Directors granted Mr. Lundgren an initial equity option to purchase 1,000,000 shares of common stock of the company under the Immunic, Inc. 2026 Inducement Equity Compensation Plan (the "Options"). The Options were granted as an inducement material to Mr. Lundgren's commencement of employment pursuant to NASDAQ Listing Rule 5635(c)(4). The Options will be time vested, with 25% vesting on the one-year anniversary of May 22, 2026 and the remainder vesting on a monthly basis in 36 equal installments.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the appointment of Mr. Lundgren and his integration into the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomic trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-appoints-distinguished-biopharmaceutical-executive-erik-lundgren-as-chief-executive-officer-302782595.htmlSOURCE Immunic, Inc. Original: Immunic Appoints Distinguished Biopharmaceutical Executive Erik Lundgren as Chief Executive Officer

Immunic Appoints Seasoned Biopharmaceutical Executive Michael W. Bonney as Chair of the Board of DirectorsMay 19, 2026 6:30 AM
PR Newswire (US) – More Than 30 Years of Leadership Experience Across Biopharmaceutical Commercialization –– Played Key Role in the Launch and Commercial Success of Avonex® for Multiple Sclerosis –NEW YORK, May 19, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Michael "Mike" W. Bonney, a highly experienced biopharmaceutical executive and board leader, as Chair of its Board of Directors, effective May 16, 2026. Simona Skerjanec, M.Pharm, MBA, will transition from Interim Chairperson to continue serving as a member of the Board.Mr. Bonney brings more than three decades of leadership experience in the biopharmaceutical industry, including significant expertise in multiple sclerosis (MS) and broader central nervous system markets. Notably, during his tenure at Biogen Inc., he held senior commercial leadership roles and was closely involved in the launch and growth of Avonex®, one of the first widely adopted therapies for relapsing forms of MS. This treatment helped to build one of the industry's foundational neurology franchises.After his time at Biogen, Mr. Bonney served as Chief Executive Officer of Cubist Pharmaceuticals, where, for more than 10 years, he led the company through a period of significant growth. Most notably, this included the successful commercialization of Cubicin®, an antibiotic medicine, and the company's subsequent acquisition by Merck & Co. for approximately $9.5 billion. Earlier, Mr. Bonney spent over a decade at Zeneca Pharmaceuticals in a range of commercial, operating, and strategic roles, culminating as National Business Director. Throughout his distinguished career, Mr. Bonney has consistently supported companies advancing innovative therapies through late-stage development and commercialization.Mr. Bonney has extensive board leadership experience across the biopharmaceutical sector. In addition to Immunic, he currently serves as Chair of the Board of Autolus Therapeutics plc, Dunad Therapeutics LTD and Santa Ana Bio, Inc. He has also served as Chair or Director of companies including Alnylam Pharmaceuticals, Inc., Bristol Myers Squibb, Celgene Corporation, Kaleido Biosciences, Inc., Magenta Therapeutics, Inc., Sarepta Therapeutics, Inc. and Syros Pharmaceuticals, Inc."I would like to welcome Mike as Chair of the Board at what is, without question, a defining stage of growth for Immunic," stated Ms. Skerjanec. "His extensive experience in biotech and achievements throughout his career as a CEO, chair and member of the board, as well as his MS experience in the launch and growth of Avonex® during his time at Biogen are all highly relevant as we advance vidofludimus calcium toward potential regulatory approval and commercial readiness.""I am excited to join Immunic at such a pivotal time, ahead of the readout of the phase 3 ENSURE trials of vidofludimus calcium in relapsing MS and the planned phase 3 development program in primary progressive MS," stated Mr. Bonney. "Designed to combine neuroprotective, anti-inflammatory and anti-viral effects, vidofludimus calcium offers a potential differentiated profile within the MS treatment landscape. I look forward to working closely with the entire Board and management team to support Immunic's upcoming milestones and its broader regulatory and commercial strategy.""On behalf of the entire Immunic team, I would like to thank Simona for her strong leadership as Interim Chairperson and her continued role as a member of our Board, going forward," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Mike's proven abilities in executive leadership at Cubist, combined with his success in helping to make Avonex® a blockbuster therapy for MS, are attributes that will be invaluable to Immunic in the months and years to come. We look forward to leveraging all of Mike's experience as we plan to transition toward becoming a fully integrated commercial-stage company."About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; changes to the leadership of the board of directors; new appointments to Immunic's board of directors; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-appoints-seasoned-biopharmaceutical-executive-michael-w-bonney-as-chair-of-the-board-of-directors-302774994.htmlSOURCE Immunic, Inc. Original: Immunic Appoints Seasoned Biopharmaceutical Executive Michael W. Bonney as Chair of the Board of Directors

Immunic, Inc. Reports First Quarter 2026 Financial Results and Provides Corporate UpdateMay 13, 2026 6:30 AM
PR Newswire (US) – Appointed Globally Renowned Biopharmaceutical Executive and Neurology Drug Developer, Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer –– Continued to Execute Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis, with Top-Line Data Expected by End of 2026 –– Raised $200 Million in an Oversubscribed Private Placement, with Potential for up to an Additional $200 Million –NEW YORK, May 13, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update."We are fast approaching a highly pivotal juncture, with the anticipated top-line data readout of the twin phase 3 ENSURE trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing multiple sclerosis (RMS), expected by the end of 2026," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "In anticipation, we strengthened our leadership team with the recent appointment of Dr. Michael A. Panzara as Chief Medical Officer. Mike brings deep expertise in neurology and a proven track record of advancing multiple sclerosis (MS) therapies through late-stage clinical development and global regulatory approvals. Additionally, we enhanced our Board of Directors with the appointment of Jon Congleton, who has nearly four decades of biopharmaceutical leadership experience. Earlier in the quarter, Simona Skerjanec, M.Pharm, M.B.A., who joined Immunic's Board of Directors in July 2024, has been elevated to interim Chairperson of the Board and Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board. Together, these key appointments are intended to best position the company for successful execution of our late-stage development priorities and prepare for potential commercialization."Dr. Vitt continued, "As important, in February, we closed an oversubscribed private placement financing of up to $400 million in gross proceeds, with $200 million received upfront. This highly successful transaction signals investors' continued confidence in Immunic and has provided the resources we need to advance our programs through key milestones and to continue our transition into a commercial-stage company. The initial proceeds are expected to fund our operations through the completion of our phase 3 ENSURE trials in RMS and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027. The funds will also support continued investment in our development organization and launch readiness. At the same time, we remain focused on expanding the opportunity for vidofludimus calcium beyond RMS, which is supported by the growing body of data from our phase 2 CALLIPER trial in progressive MS (PMS) and our plan to initiate a confirmatory phase 3 program in primary progressive MS (PPMS) later this year."Jason Tardio, President and Chief Operating Officer of Immunic, added, "We believe vidofludimus calcium has the potential to offer a transformative approach to disease modification in MS. Unlike currently available oral therapies that primarily target inflammatory pathways, vidofludimus calcium is designed to deliver both direct neuroprotective effects through Nurr1 activation and anti-inflammatory activity via selective DHODH inhibition. In clinical trials to date, vidofludimus calcium has demonstrated a favorable safety and tolerability profile. Taken together, these attributes may support a compelling benefit-risk profile in the global MS market, which is projected to exceed $30 billion by the early 2030s."First Quarter 2026 and Subsequent HighlightsApril 2026: Appointed accomplished biopharmaceutical executive Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer, to lead the company's development organization, including clinical development, medical affairs, and regulatory affairs. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A., who will continue to support the company as a consultant.April 2026: Effected 1-for-10 reverse stock split of the outstanding shares of common stock as of April 27, 2026.April 2026: Regained compliance with Nasdaq minimum bid price requirement (Rule 5550(a)(2)) for continued listing, following receipt of a written notice on March 27, 2026.March 2026: Appointed Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to the Board of Directors.March 2026: Announced grant of a key European patent from the European Patent Office (EPO) directed to label-relevant dosing regimens of vidofludimus calcium. The patent is expected to provide protection into 2038 and may be eligible for a Supplementary Protection Certificate (SPC), which could extend market exclusivity potentially into 2043. This patent was previously granted by the United States Patent and Trademark Office (USPTO) in 2023.February 2026: Completed an oversubscribed private placement financing of up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received upon closing on February 17, 2026.Elevated Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Appointed Thor Nagel, Principal at BVF Partners L.P., to the Board. Plans underway for further Board refreshment to support the company's evolution into a commercial-stage organization.Initiated search for a new Chief Executive Officer with deep commercial expertise in neurology to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his roots and transition to a new senior executive role focused on scientific strategy and portfolio advancement, while remaining on the Board.February 2026: Presented additional data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the ACTRIMS Forum 2026 in San Diego, California. The findings, presented in two poster presentations, provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce Immunic's belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.Anticipated Clinical MilestonesVidofludimus calcium in MS:Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. Subsequently, Immunic plans to submit an NDA in the United States in mid-2027, with a targeted potential regulatory approval date in 2028.Initiation of a phase 3 clinical program in PPMS is expected later this year and is estimated to take approximately 3.5 to 4 years to complete.IMU-856: The company is currently exploring strategic alternatives for the IMU-856 program and is open to discussing potential financing, licensing or partnering options with interested parties.Financial and Operating ResultsResearch and Development (R&D) Expenses were $25.6 million for the three months ended March 31, 2026, as compared to $21.5 million for the three months ended March 31, 2025. The $4.1 million increase reflects (i) a $2.9 million increase in external development costs related to the vidofludimus calcium program, (ii) a $1.0 million increase in personnel expenses, $0.7 million of which was related to non-cash stock compensation and (iii) a $0.2 million increase related to costs across numerous categories.General and Administrative (G&A) Expenses were $7.6 million for the three months ended March 31, 2026, as compared to $5.3 million for the same period ended March 31, 2025. The $2.3 million increase was due to (i) a $2.0 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation, (ii) a $0.2 million increase in legal and consultancy expenses, (iii) a $0.2 million increase in marketing expenses, which was partially offset by a $0.1 million decrease related to costs across numerous categories.Interest Income was $0.8 million for the three months ended March 31, 2026, as compared to $0.2 million for the three months ended March 31, 2025. The $0.6 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement.Other Income (Expense) was ($0.1) million for the three months ended March 31, 2026, as compared to $1.2 million for the same period ended March 31, 2025. The $1.3 million decrease was primarily attributable to (i) a $1.1 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and no grant income in 2026 and (ii) a $0.2 million decrease across numerous categories.Net Loss for the three months ended March 31, 2026, was approximately $32.6 million, or $1.08 per basic and diluted share, based on 30,136,324 weighted average common shares outstanding, compared to a net loss of approximately $25.5 million, or $2.51 per basic and diluted share, based on 10,134,443 weighted average common shares outstanding for the same period ended March 31, 2025.Cash and Cash Equivalents as of March 31, 2026 were $186.6 million. With these funds, Immunic expects to be able to fund its operations into late 2027.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.comFinancialsImmunic, Inc.Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts)(Unaudited)


Three Months Ended March 31,

2026
2025Operating expenses:



Research and development
$    25,626
$    21,533General and administrative
7,609
5,292Total operating expenses
33,235
26,825Loss from operations
(33,235)
(26,825)Other income:



Interest income
760
183Other  income (expense), net
(113)
1,169Total other income
647
1,352Net loss
$   (32,588)
$   (25,473)




Net loss per share, basic and diluted
$     (1.08)
$     (2.51)




Weighted-average common shares outstanding, basic and diluted
30,136,324
10,134,443

Immunic, Inc.Condensed Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited)


March 31,
2026
December 31,
2025

(Unaudited)

Assets



Current assets:



Cash and cash equivalents
$     186,629
$          15,483Prepaid expenses and other current assets
2,130
7,386Total current assets
188,759
22,869Property and equipment, net
566
608Right-of-use assets, net
417
575Total assets
$     189,742
$          24,052Liabilities and Stockholders' Equity (Deficit)



Current liabilities:



Accounts payable
$       11,011
$          10,138Accrued expenses
22,432
18,645Other current liabilities
4,920
1,835Total current liabilities
38,363
30,618Long-term liabilities



Operating lease liabilities
146
107Total long-term liabilities
146
107Total liabilities
38,509
30,725Commitments and contingencies



Stockholders' equity (deficit):



Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued
or outstanding as of March 31, 2026 and December 31, 2025
—
—Common stock, $0.0001 par value; 500,000,000 shares authorized as of March
31, 2026 and December 31, 2025 and 13,621,483 and 12,038,263 shares issued
and outstanding as of March 31, 2026 and December 31, 2025, respectively.
11
9Additional paid-in capital
789,324
599,241Accumulated other comprehensive income
3,057
2,648Accumulated deficit
(641,159)
(608,571)Total stockholders' equity (deficit)
151,233
(6,673)Total liabilities and stockholders' equity (deficit)
$     189,742
$          24,052   View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-inc-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302769899.htmlSOURCE Immunic, Inc. Original: Immunic, Inc. Reports First Quarter 2026 Financial Results and Provides Corporate Update

Immunic to Participate in Investor and Medical Conferences in MayApril 30, 2026 6:30 AM
PR Newswire (US)

NEW YORK, April 30, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced participation in the following investor and medical conferences in May:May 4-6 and 12-13: 26th Bio€quity Europe. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, and Jessica Breu, Vice President Investor Relations and Communications at Immunic, will attend and host one-on-one investor meetings at this conference taking place in Prague, Czech Republic and virtually. To schedule a meeting, please use the Bio€quity Europe conference portal or contact Jessica Breu at: jessica.breu @gbpa: 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. Members of Immunic's management, medical and preclinical teams will attend this meeting in Charlotte, NC. One late-breaking poster and two additional posters have been accepted for presentation and will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, the team will be available throughout the event at booth #307.Late-Breaking Poster Presentation:Title: Novel Unified Statistical Analyses for Confirmed Disability Changes In Multiple Sclerosis for Capturing Possible Neuroprotective EffectsPresenting Author: James Myles, Global Head of Biostatistics at ImmunicAbstract ID: 11244Poster Board Label: LBA14Session Date: Thursday, May 28, 2026Session Time: 5:00-7:00 pm ETLocation: Exhibit HallPoster Presentations:Title: Effect of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor, on Patient-Reported Outcomes (PRO) in Progressive MS: Data from Phase 2 CALLIPER TrialPresenting Author: Julie Korich, Ph.D., Senior Medical Director, Medical Affairs at ImmunicAbstract ID: 10843Poster Board Label: DMT10Session Date: Thursday, May 28, 2026Session Time: 5:00-7:00 pm ETLocation: Exhibit Hall BTitle: Safety and Tolerability of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor: Data from Phase 2 CALLIPER TrialPresenting Author: Alex Lublin, Ph.D., Senior Medical Director, Medical Affairs at ImmunicAbstract ID: 10995Poster Board Label: DMT11Session Date: Thursday, May 28, 2026Session Time: 5:00-7:00 pm ETLocation: Exhibit Hall BAbout Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to management's and employee's participation in investor and medical conferences. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com 





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Original: Immunic to Participate in Investor and Medical Conferences in May

Immunic Appoints Accomplished Biopharmaceutical Executive Michael A. Panzara, M.D., M.P.H., as Chief Medical OfficerApril 28, 2026 6:30 AM
PR Newswire (US)

– Proven Leader in Neurology Drug Development, Including for Several Approved Multiple
Sclerosis Therapies –– Strong Experience in Advancing Late-Stage Clinical Programs and Obtaining Global Regulatory Approvals, Key to Supporting Vidofludimus Calcium Through Pivotal Development –NEW YORK, April 28, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer, effective April 24, 2026. Dr. Panzara will lead the company's 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 succeeds Andreas Muehler, M.D., M.B.A.."Mike is a globally renowned biopharmaceutical executive and drug developer with deep expertise in neurology and proven leadership in advancing transformational therapies through development and the regulatory approval process," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Notably, during his tenure at Sanofi Genzyme, Mike oversaw the global regulatory approvals of the multiple sclerosis (MS) drugs LEMTRADA® and AUBAGIO®. During his time at Biogen, he served as global clinical lead for the development of TYSABRI® and managed their late-stage portfolio of MS products. His depth of experience will be invaluable as we advance vidofludimus calcium through the pivotal clinical readout of our phase 3 ENSURE trials in relapsing MS, and toward potential regulatory approval and commercialization in this indication. His leadership will support the company strategy as we continue our transition into a fully integrated commercial-stage company.""This is a critically important time in Immunic's evolution and I am excited to be joining the company at such a pivotal inflection point," said Dr. Panzara. "Vidofludimus calcium's potential to treat MS by targeting both immunological and neuroprotective pathways holds promise to redefine the treatment landscape and meaningfully impact the lives of so many people who continue to struggle with their MS. I look forward to building upon the team's successes to further advance Immunic's clinical programs, including the phase 3 ENSURE trials and the planned phase 3 trial of vidofludimus calcium in primary progressive MS."Dr. Panzara brings over 25 years of global neurology experience to Immunic. He most recently served as Chief Medical Officer of Neurvati Neurosciences, Inc., where he built a Development Organization to support the creation of sub-companies focused on advancing therapeutic candidates in neurological and psychiatric disorders. This included serving as Chief Medical Officer of Neurvati's first sub-company, GRIN Therapeutics, overseeing development of radiprodil, a negative allosteric modulator targeting the NMDA receptor as a potential treatment for rare genetically defined neurodevelopmental disorders. Prior to Neurvati, Dr. Panzara served as Chief Medical Officer and Head of Therapeutics Discovery and Development at Wave Life Sciences Ltd., after initially joining the company as Franchise Lead, Neurology, where he oversaw Wave's therapeutic research and development portfolio with a focus on genetically-defined neurological diseases. Earlier, he served as the Head of the Multiple Sclerosis, Neurology and Ophthalmology Therapeutic Area for Global Development at Sanofi Genzyme, where he oversaw global regulatory approvals of the MS drugs LEMTRADA® (alemtuzumab) and AUBAGIO® (teriflunomide) and was responsible for development strategy and oversight within these therapeutic areas. Prior to joining Sanofi Genzyme, Dr. Panzara was Vice President and Chief Medical Officer of Neurology at Biogen. During his time there, he served as the global clinical lead for the development of TYSABRI® (natalizumab) for MS, overseeing its clinical program and global approvals, and managed clinical development activities for all late-stage MS products, including AVONEX® (interferon beta-1a), PLEGRIDY® (PEG-interferon beta-1a), and TECFIDERA® (dimethyl fumarate). He currently serves on the Boards of Directors of LeonaBio, Inc. and Cadenza Bio, Inc..Dr. Panzara received his undergraduate degree in biology from the University of Pennsylvania and his medical degree from Stanford University School of Medicine. He completed his neurology training at Massachusetts General Hospital and conducted postdoctoral training in immunology and rheumatology at Brigham and Women's Hospital. He also holds a Master of Public Health from the Harvard School of Public Health.Dr. Vitt added, "On behalf of the entire team, I would like to sincerely thank Andreas for his leadership and invaluable contributions as Co-Founder and Chief Medical Officer of Immunic. It is due in large part to his expertise and stewardship that vidofludimus calcium has advanced successfully into late-stage clinical development. That said, we are delighted that he will continue to support the company as a consultant during this key phase for Immunic and our evolution into a fully-fledged commercial company.""It has been a true privilege to serve as Chief Medical Officer of Immunic for the past 10 years," said Dr. Muehler. "During this time, I had the opportunity to build and grow the clinical development organization and advance the company's development pipeline. Most notably, we progressed vidofludimus calcium from the preclinical stage into late-stage clinical development, achieving clinical proof-of-concept in both relapsing and progressive MS, and are now just months away from the pivotal phase 3 readout in relapsing MS. This journey has truly been a team effort. I have been fortunate to work alongside an exceptional group of colleagues, whose dedication and expertise made these achievements possible. I am delighted to pass the baton to Dr. Panzara, whose extensive medical, clinical and regulatory background makes him ideally suited to guide vidofludimus calcium into its next chapter. I am immensely proud of what our team has accomplished and remain highly confident in Immunic's potential to make a meaningful impact in the MS space by delivering a unique and innovative new therapeutic option for patients living with this devastating disease."The Compensation Committee of Immunic's Board of Directors granted Dr. Panzara an initial equity option to purchase 300,000 shares of common stock of the company under the Immunic, Inc. 2026 Inducement Equity Compensation Plan (the "Options"). The Options were granted as an inducement material to Dr. Panzara's commencement of employment pursuant to NASDAQ Listing Rule 5635(c)(4). The Options will be time vested, with one half vesting on the one-year anniversary of April 24, 2026 and one half vesting in equal monthly installments over a period of twenty-four (24) months following the first anniversary of April 24, 2026.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to expectations regarding the appointment of Dr. Panzara and his integration into the company; Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com





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Original: Immunic Appoints Accomplished Biopharmaceutical Executive Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer

Immunic, Inc. Announces 1-for-10 Reverse Stock SplitApril 23, 2026 8:00 AM
PR Newswire (US)

NEW YORK, April 23, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases (the "Company" or "Immunic"), today announced that it will effect a reverse stock split of its outstanding shares of common stock, effective as of 12:01 a.m. Eastern Time on April 27, 2026.Immunic's common stock will continue to be traded on the Nasdaq Capital Market under the symbol "IMUX" and will begin trading on a reverse stock split-adjusted basis at the opening of the Nasdaq Capital Market on April 27, 2026. The new CUSIP number for the split-adjusted common stock will be 4525EP200.At the Company's special meeting of stockholders on April 14, 2026, the stockholders approved a proposal to amend the Company's certificate of incorporation to effect a reverse split of the Company's outstanding common stock at a ratio in the range of 1-for-10 to 1-for-30, with such final ratio to be determined at the discretion of the Board of Directors (the "Board"). The specific 1-for-10 ratio was subsequently determined by the Board. The reverse stock split is primarily intended to allow Immunic to meet its contractual obligations under the securities purchase agreement entered into between the Company and certain institutional and accredited investors on February 12, 2026.Immunic has filed an amendment to its certificate of incorporation, which was accepted for filing by the Department of State of Delaware on April 22, 2026. Upon the effectiveness of the reverse stock split at 12:01 a.m. on April 27, 2026, every ten shares of issued and outstanding common stock will automatically be combined and converted into one issued and outstanding share of common stock. No fractional shares will be issued in connection with the reverse stock split. In lieu thereof, the Company's transfer agent shall aggregate all fractional shares of common stock that would otherwise have been issued as a result of the reverse stock split into whole shares of common stock and shall arrange for the sale of such whole shares on the open market at then-prevailing prices. Stockholders of record who otherwise would be entitled to receive fractional shares because they hold a number of shares of common stock not evenly divisible by the reverse stock split ratio shall be entitled to receive, in lieu thereof, a cash payment equal to such holder's allocable share of the total proceeds of such sales, without interest, and such cash payment shall be made as soon as practicable following the effective time of the reverse stock split. The reverse stock split will reduce the number of issued and outstanding shares of Immunic's common stock from approximately 136 million to approximately 13.6 million.The reverse stock split will not reduce the number of authorized shares of common stock or change the par value of the common stock. The reverse stock split will affect all stockholders uniformly and will not affect any stockholder's ownership percentage of Immunic's shares of common stock (except to the extent that the reverse stock split would result in some of the stockholders receiving cash in lieu of fractional shares). The common stock issued pursuant to the reverse stock split will remain fully paid and non-assessable. All outstanding stock options, warrants, restricted stock units, and similar securities entitling their holders to receive or purchase shares of common stock will be proportionally adjusted as a result of the reverse stock split, both in terms of their exercise prices or other stock price thresholds and as well as to the number of underlying shares, as required by the terms of each security.Detailed information about the reverse stock split can be found in the definitive proxy statement filed with the Securities and Exchange Commission on March 2, 2026, a copy of which is available on the Company's website under the Investor Relations page.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "to be," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook," and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Examples of such statements include, but are not limited to, statements relating to the timing and consummation of the Company's reverse stock split. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com





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Original: Immunic, Inc. Announces 1-for-10 Reverse Stock Split

Immunic to Participate in Scientific and Medical Conferences in AprilApril 9, 2026 6:30 AM
PR Newswire (US)

NEW YORK, April 9, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced participation in the following scientific and medical conferences in April:April 14-16: 8th Annual Neuroimmunology Drug Development Summit. Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will give a presentation highlighting lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), at this conference in Boston. The presentation will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Presentation Title: Vidofludimus Calcium Uniquely Combines Direct Neuroprotective & Anti-inflammatory Properties for the Treatment of Multiple SclerosisPresenting Author: Hella Kohlhof, Ph.D., Chief Scientific Officer of ImmunicSession Title: Beyond Microglia: Unlocking New Neuroimmune Targets To Drive Innovation In CNS Drug DiscoverySession Date: Thursday, April 16, 2026Session Time: 12:00 pm ETApril 18-22: 2026 American Academy of Neurology (AAN) Annual Meeting. Members of Immunic's management, medical and preclinical teams will attend this meeting in Chicago. The team will be available throughout the event at booth #3830.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to management's and employee's participation in scientific and medical conferences. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com 





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Original: Immunic to Participate in Scientific and Medical Conferences in April

IMUX..................................https://stockcharts.com/sc3/ui/?s=IMUX&p=w&b=5&g=0&id=p86431144783

Immunic Regains Compliance with Nasdaq Minimum Bid Price RequirementApril 1, 2026 6:30 AM
PR Newswire (US)

NEW YORK, April 1, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced that it received written notice (the "Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") on March 27, 2026, informing the company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.According to the Notice, Immunic has regained compliance with the minimum bid price requirement, because the closing bid price of the Company's common stock was at $1.00 per share or greater for at least 20 consecutive business days, satisfying the Nasdaq requirement on March 26, 2026. As a result, the matter was closed.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com





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Original: Immunic Regains Compliance with Nasdaq Minimum Bid Price Requirement

Immunic Strengthens Its Board of Directors with the Appointment of Seasoned Biopharmaceutical Executive Jon CongletonMarch 31, 2026 6:30 AM
PR Newswire (US)

– Nearly 40-Year Biopharmaceutical Professional with Deep CNS and Commercial Leadership Experience in Multiple Sclerosis –– Served on Original Team Responsible for the Launch of Copaxone® in the United States –NEW YORK, March 31, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to its Board of Directors, effective March 27, 2026.Mr. Congleton has a strong track record of building and leading biopharmaceutical organizations and advancing innovative therapies. During his career, he has worked across cardiovascular, gastrointestinal, and central nervous system (CNS) organizations, with a focus on delivering solutions for patients and their caregivers. He played a key role in the U.S. launch of Teva Pharmaceuticals Industries Ltd.'s Copaxone®, a subcutaneous injection treatment for relapsing forms of multiple sclerosis (MS), and led the U.S. operations when it became the number one prescribed MS treatment.Mr. Congleton currently serves as Chief Executive Officer (CEO) and member of the Board of Directors of Mineralys Therapeutics, Inc., focused on aldosterone-driven cardiorenal conditions. As CEO, he guided the company from an early-stage private entity to the publicly traded, pre-commercial biotechnology firm it is today. Previously, he served as CEO and Board member of both CNS company Impel NeuroPharma, Inc. and cystic fibrosis company Nivalis Therapeutics, Inc.. Earlier, Mr. Congleton held several senior leadership roles at Teva Pharmaceuticals, eventually leading its United States and Canadian neuroscience businesses and global CNS franchise."MS remains a devastating disease for the patients and their families. Jon's deep CNS expertise and proven track record in late-stage drug development and commercialization will be invaluable as we advance vidofludimus calcium through its pivotal clinical milestones and toward potential regulatory approval and commercial launch," stated Simona Skerjanec, M.Pharm, MBA, Interim Chairperson of the Board of Directors of Immunic. "I am thrilled that Jon is joining us at this critical moment as we evolve our Board to support Immunic in its transition into a fully integrated commercial-stage company.""I am excited to join Immunic's Board at such a pivotal moment for the company's MS program," added Mr. Congleton. "Vidofludimus calcium represents a potentially transformative opportunity for MS patients, offering advantages over currently available therapies, particularly with its unique combination of neuroprotective, anti-inflammatory and anti-viral effects as well as its favorable safety and tolerability profile shown to date. I look forward to working with the Board and the leadership team and contributing my experience to support Immunic as it advances toward the pivotal trial readouts later this year and long-term value creation."About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; new appointments to Immunic's board of directors; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com





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Original: Immunic Strengthens Its Board of Directors with the Appointment of Seasoned Biopharmaceutical Executive Jon Congleton

Immunic Announces Grant of Key European Patent Protecting Relevant Dosing Regimens for Vidofludimus CalciumMarch 10, 2026 6:30 AM
PR Newswire (US)

– Patent Covers Label-Mandated Dosing Scheme Across All Indications, Including Multiple Sclerosis; Previously Granted by the USPTO in 2023 –– Broad Protection Extends to All Forms of Vidofludimus, Including Its Salts, Solvates and Free Acid –– Multi-Layered Intellectual Property Strategy Expected to Provide Protection at Least Into 2041 in the United States and Into 2039 in Europe –NEW YORK, March 10, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced that the European Patent Office (EPO) has granted a key European patent, EP3713554, directed to label-relevant dosing regimens of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838). 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.The claims broadly protect vidofludimus and its salt, solvate and free acid forms, in all label-relevant dosing regimens. This protection extends beyond a specific salt form, meaning that even alternative salts or forms will fall within the scope of the patent if used according to the label."Receiving this key patent in Europe represents a highly important advancement in our global intellectual property strategy for vidofludimus calcium and further reinforces the durability of our exclusivity position," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "This patent creates a particularly robust layer of protection that is difficult to design around, independent of indication or formulation. Together with our existing composition-of-matter, indication, method-of-treatment, dosing, process of production and formulation patents, this European patent significantly strengthens the multi-layered protection we have built around vidofludimus calcium. We will continue to expand this portfolio with the goal of maximizing long-term exclusivity following potential regulatory approval."Vidofludimus calcium is protected by several layers of granted patents in the United States, Europe and other jurisdictions around the world. These patents are directed towards composition-of-matter for forms of vidofludimus calcium; the treatment of relapsing-remitting multiple sclerosis with a specific dose strength used in the clinical trials; the treatment of progressive multiple sclerosis with specific dose strengths used in the clinical trials; the dosing regimens, including those used in clinical trials for the treatment of multiple sclerosis, as well as composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. In the United States, these patents provide protection into 2041, unless extended further. In addition, pending applications are directed towards the use of vidofludimus calcium and other salt forms as well as free acid forms for treating neurodegenerative diseases, which, if granted, could provide protection up to 2044, unless extended further, and the pharmaceutical product (formulation, production process and impurity profile), which, if granted, could provide protection up to 2045, unless extended further. Further undisclosed patent applications dedicated to strengthening the exclusivity period are currently in process. In addition to patent exclusivity, vidofludimus calcium, as a new chemical entity, is expected to benefit from regulatory data protection.About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis (MS). Vidofludimus calcium's unique mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of MS. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for the treatment of relapsing MS. In a phase 2 clinical trial, it showed therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. Additionally, vidofludimus calcium demonstrated clinical benefits in progressive MS patients by showing substantial reductions in confirmed disability progression and statistically significant confirmed disability improvement in a phase 2 clinical trial. To date, vidofludimus calcium has been exposed to more than 3,400 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases such as celiac disease, inflammatory bowel disease, and graft-versus-host disease. IMU-381 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging the company's Nurr1 platform. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com





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Original: Immunic Announces Grant of Key European Patent Protecting Relevant Dosing Regimens for Vidofludimus Calcium

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Immunic to Participate in Investor Conferences in MarchMarch 3, 2026 6:30 AM
PR Newswire (US)

NEW YORK, March 3, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced participation in the following investor conferences in March:March 8-11: Leerink Partners Global Healthcare Conference. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, and Jason Tardio, President and Chief Operating Officer of Immunic, will participate in a fireside chat on Wednesday, March 11, at 10:40 am ET at this conference in Miami. A webcast will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Dr. Vitt, Mr. Tardio and Jessica Breu, Vice President Investor Relations and Communications at Immunic, will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Leerink representative or Jessica Breu at: jessica.breu @garrettashton: Stifel 2026 Virtual CNS Forum. Dr. Vitt and Mr. Tardio will participate in a fireside chat on Wednesday, March 18, at 4:00 pm ET at this virtual conference. A webcast will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Dr. Vitt, Mr. Tardio and Mrs. Breu will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Stifel representative or Jessica Breu at: jessica.breu@imux.com.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases such as celiac disease, inflammatory bowel disease, and Graft-versus-Host-Disease. IMU-381 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging the company's Nurr1 platform. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to management's and employee's participation in investor conferences. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com





View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-to-participate-in-investor-conferences-in-march-302702020.htmlSOURCE Immunic, Inc.

Original: Immunic to Participate in Investor Conferences in March

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Immunic, Inc. Reports Year-End 2025 Financial Results and Provides Corporate UpdateFebruary 26, 2026 6:30 AM
PR Newswire (US)

– Top-Line Data from Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 –– Raised Proceeds of $200 Million in a Private Placement, with Potential for up to an Additional $200 Million –– Net Proceeds Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive Multiple Sclerosis and Begin of Transition into a Commercial Organization –NEW YORK, Feb. 26, 2026  /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the year ended December 31, 2025, and provided a corporate update."The phase 3 ENSURE-1 and ENSURE-2 trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) continue to progress, with top-line data expected to be available by the end of 2026," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "As we continue to advance our multiple sclerosis (MS) program with vidofludimus calcium, we were extremely pleased to have recently announced the successful completion of an oversubscribed private placement of up to $400 million in gross proceeds, with $200 million in upfront gross proceeds. This financing is truly a pivotal milestone for Immunic and positions us to confidently transition into a fully integrated commercial-stage company. The transaction was led by our existing investor BVF Partners L.P. with participation from a group of highly regarded new and other existing investors. This level of commitment reflects growing confidence in our program and reinforces our belief in vidofludimus calcium's potential to address the underlying drivers of MS progression.""The proceeds from the initial closing are expected to fund our operations through the ENSURE top-line data and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027, with a targeted potential regulatory approval date in 2028," continued Dr. Vitt. "They also support preparations for the potential launch of vidofludimus calcium in RMS, including expansion of our medical and commercial infrastructure. Additionally, based on the totality of the phase 2 CALLIPER trial data in progressive MS, which showed not only substantial and medically relevant reductions for vidofludimus calcium in delaying 24-week confirmed disability progression but also statistically significant 24-week confirmed disability improvement, while confirming the drug's favorable safety and tolerability profile already observed in previous clinical trials, we plan to initiate a confirmatory phase 3 program in primary progressive multiple sclerosis (PPMS) later this year as well."Jason Tardio, President and Chief Operating Officer of Immunic, added, "This is an exciting moment for Immunic and for individuals living with MS, as we believe that vidofludimus calcium could represent a potentially transformative approach to disease modification. Current oral therapies for RMS mainly control inflammation and relapses, often have complex safety and tolerability issues and do not adequately address the neurodegenerative processes driving disability progression and long-term disability. In contrast, vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through Nurr1 activation, while reducing new inflammatory damage via selective DHODH inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses. As such, we believe vidofludimus calcium may achieve a best-in-class benefit-risk profile and, therefore, could represent a large commercial opportunity in the global MS market, which is projected to reach over $30 billion by the early 2030s."Fourth Quarter 2025 and Subsequent HighlightsFebruary 2026: Completed an oversubscribed private placement of up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received upon closing on February 17, 2026.Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, elevated to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Thor Nagel, Principal at BVF Partners L.P., appointed to the Board. Plans underway for further Board refreshment to support the company's evolution into a commercial-stage organization. Initiated search for a new Chief Executive Officer with deep commercial expertise in MS to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his roots and transition to a new senior executive role focused on scientific strategy and portfolio advancement, while remaining on the Board.February 2026: Presented additional data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive MS at the ACTRIMS Forum 2026. The findings, presented in two poster presentations, provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce Immunic's belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.Anticipated Clinical MilestonesVidofludimus calcium in MS:Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. Subsequently, Immunic plans to submit an NDA in the United States in mid-2027, with a targeted potential regulatory approval date in 2028.Initiation of a phase 3 clinical program in PPMS is expected later this year and estimated to take approximately 3.5 to 4 years to complete.IMU-856: The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.Financial and Operating ResultsResearch and Development (R&D) Expenses were $82.0 million for the twelve months ended December 31, 2025, as compared to $80.0 million for the twelve months ended December 31, 2024. The $1.9 million increase reflects (i) a $3.9 million increase in external development costs related to the vidofludimus calcium program and (ii) a $1.8 million increase in personnel expenses for R&D. The increase was offset by (i) a $3.0 million decrease in external development costs related to IMU-856 and (ii) a $0.8 million decrease across numerous categories.General and Administrative (G&A) Expenses were $21.2 million for the twelve months ended December 31, 2025, as compared to $18.0 million for the same period ended December 31, 2024. The $3.2 million increase was due to (i) a $1.9 million increase related to personnel expenses, of which $0.3 million was related to non-cash stock compensation, (ii) a $0.8 million increase in legal and consultancy expenses and (iii) a $0.5 million increase related to costs across numerous categories.Interest Income was $1.0 million for the twelve months ended December 31, 2025, as compared to $3.4 million for the twelve months ended December 31, 2024. The $2.4 million decrease was due to a lower average cash balance.In the twelve months ended December 31, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the company's authorized shares from 130 million to 500 million shares of common stock and, therefore, the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the twelve months ended December 31, 2025.Other Income (Expense) was $5.0 million for the twelve months ended December 31, 2025, as compared to ($1.0 million) for the same period ended December 31, 2024. The $6.1 million increase was primarily attributable to (i) $4.8 million of grant income from the German Federal Ministry of Finance, of which $1.0 million was recognized in the first quarter 2025 and $3.8 million was recognized in the fourth quarter 2025, (ii) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia.Net Loss for the twelve months ended December 31, 2025, was approximately $97.2 million, or $0.62 per basic and diluted share, based on 155,688,030 weighted average common shares outstanding, compared to a net loss of approximately $100.5 million, or $1.00 per basic and diluted share, based on 100,174,766 weighted average common shares outstanding for the same period ended December 31, 2024.Cash and Cash Equivalents as of December 31, 2025 were approximately $15.5 million. With these funds and the approximately $187.0 million net cash proceeds raised in the February 2026 private placement, Immunic expects to be able to fund its operations into late 2027.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases such as celiac disease, inflammatory bowel disease, and Graft-versus-Host-Disease. IMU-381 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging the company's Nurr1 platform. For further information, please visit: www.imux.com.Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.comFinancialsImmunic, Inc.Consolidated Statements of Operations(In thousands, except share and per share amounts)(Unaudited)

Years Ended December 31,
2025
2024Operating expenses:


Research and development$           81,983
$           80,046General and administrative21,245
18,006Total operating expenses103,228
98,052Loss from operations(103,228)
(98,052)Other income (expense):


Interest income1,040
3,390Change in fair value of the tranche rights—
(4,796)Other income (expense), net5,016
(1,049)Total other income (expense), net6,056
(2,455)Net loss$          (97,172)
$       (100,507)



Net loss per share, basic and diluted$              (0.62)
$              (1.00)



Weighted-average common shares outstanding, basic and diluted155,688,030
100,174,766 Immunic, Inc.Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited)

December 31,
2025
2024Assets


Current assets:


Cash and cash equivalents$           15,483
$           35,668Prepaid expenses and other current assets7,386
3,664Total current assets22,869
39,332Property and equipment, net608
545Right of use asset, net575
991Total assets$           24,052
$           40,868Liabilities  and Stockholders' Equity (Deficit)


Current liabilities:


Accounts payable$           10,138
$              7,846Accrued expenses18,645
12,913Other current liabilities1,835
1,416Total current liabilities30,618
22,175Long-term liabilities:


Operating lease liabilities107
264Total long-term liabilities107
264Total liabilities30,725
22,439Commitments and contingencies


Stockholders' equity (deficit):


Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or
outstanding at December 31, 2025 and 2024—
—Common stock, $0.0001 par value; 500,000,000 shares authorized as of December
31, 2025 and December 31, 2024, respectively, and 120,382,625 and 90,150,869 
shares issued and outstanding as of December 31, 2025 and December 31, 2024,
respectively.9
8Additional paid-in capital599,241
525,611Accumulated other comprehensive income2,648
4,209Accumulated deficit(608,571)
(511,399)Total stockholders' equity (deficit)(6,673)
18,429Total liabilities and stockholders' equity (deficit)$           24,052
$           40,868 





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Original: Immunic, Inc. Reports Year-End 2025 Financial Results and Provides Corporate Update

IMUX.....................................................p/m

Immunic Announces Oversubscribed Private Placement of up to USD 400 Million to Accelerate Transformation into Commercial-Stage CompanyFebruary 13, 2026 6:30 AM
PR Newswire (US)

– Upfront Proceeds of USD 200 Million, with Potential for up to USD 200 Million in Additional Proceeds –– Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive Multiple Sclerosis, and Transition into a Commercial Organization –– Simona Skerjanec, Former SVP, Global Head of Neuroscience and Rare Diseases at Roche, Elevated to Interim Chairperson of the Board of Directors –– Thor Nagel, Principal at BVF Partners L.P., Joins Board of Directors –– Simona Skerjanec and Dr. Daniel Vitt to Lead Search for CEO with Commercial Background –NEW YORK, Feb. 13, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced the pricing of a private placement with gross proceeds of up to USD 400 million priced at the market under Nasdaq rules. The financing was led by existing investor BVF Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors.







Transformation Into Commercial-Stage CompanyThe proceeds of this financing are expected to support Immunic's strategic transition from a research and development (R&D)-focused company into a fully integrated commercial entity. In the coming months, the company will prioritize:Completion of the ongoing phase 3 ENSURE clinical trials of vidofludimus calcium in relapsing multiple sclerosis (RMS): Top-line data continues to be expected by the end of 2026. Subsequently, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. In parallel, Immunic will work on the preparations for the potential commercialization of vidofludimus calcium, including the pre-commercial ramp-up and expansion of the medical and commercial teams.Initiation of a phase 3 clinical program in primary progressive multiple sclerosis (PPMS): Immunic is working towards initiation of a phase 3 clinical program, which is expected later this year and estimated to take approximately 3.5 to 4 years to complete.With these pivotal programs underway, Immunic is positioning itself to become a leading innovator in next-generation oral therapies for relapsing and progressive forms of multiple sclerosis (MS). Vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through nuclear receptor-related 1 (Nurr1) activation, while reducing new inflammatory damage via selective dihydroorotate dehydrogenase (DHODH) inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses.Changes in Company LeadershipImmunic's Co-Founder and Chief Executive Officer, Dr. Daniel Vitt, and the Board of Directors 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.Concurrent with the transaction, Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, who joined Immunic's Board of Directors in July 2024, has been elevated to interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, will remain a member of the Board of Directors. Additionally, Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board of Directors. The Board of Directors intends to explore and evaluate further refreshment in order to better align its future composition with Immunic's strategic goals and objectives. As part of this refreshment, the Board expects that two new directors will replace existing directors at or prior to Immunic's upcoming annual meeting with a third director expected to be replaced at or prior to Immunic's 2027 annual meeting."I could not be prouder of the Immunic team and what we have achieved with vidofludimus calcium. I would like to thank BVF and the other investors in the consortium for joining our journey towards potential regulatory approval of vidofludimus calcium. The proceeds from the initial closing are expected to provide sufficient runway through submission of an NDA in the United States in mid-2027 and to start preparations for the potential launch of vidofludimus calcium in RMS, as well as initiation of a phase 3 clinical program in PPMS," commented Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We believe that now is the perfect time to prepare Immunic for its transformation into a highly successful commercial entity. As Immunic evolves from an R&D-driven organization into a fully-fledged commercial company, I have decided to return to my roots and focus my energy on further strengthening Immunic's scientific excellence. Together with our new interim Chairperson Simona and other members of our Board of Directors, I look forward to welcoming a new CEO with a strong commercial background in the MS space to lead the next phase of Immunic's growth and to guide the potential launch of our first pharmaceutical product. I will continue to support this transition process and Immunic's success in my current and future executive roles and as a member of the Board of Directors.""I want to thank Daniel for not only helping to invent vidofludimus calcium, but also for his tremendous leadership in getting the molecule and company to this position," said Duane Nash, M.D., J.D., M.B.A., member of the Immunic Board of Directors and former Chairman. "I am also delighted that Simona has agreed to take the position of interim Chairperson to steer this evolution. As the former head of Neuroscience and Rare Diseases at Roche, who personally led one of the most successful launches in MS history, she is well positioned to guide Immunic's commercial transformation efforts. In the 18 months she has been on our Board, her contributions, insights and connections have proven invaluable, and her leadership skills are impeccable. I look forward to helping support Simona and the rest of the Board in any way that I can.""I am honored to be in a position to help transform Immunic at this critical juncture," said Simona Skerjanec, newly appointed interim Chairperson of the Board of Directors of Immunic. "Despite available therapeutic options in MS, it remains a devastating disease for patients and their families and I am committed to help bring new and meaningful therapies to patients. I believe vidofludimus calcium holds the potential to address the underlying unmet need for a direct neuroprotective medicine in MS. I very much look forward to continuing to work with Daniel, Duane and the rest of Immunic's Board of Directors as we prepare Immunic for a very exciting future."Up to USD 400 Million Private PlacementThe company has entered into a securities purchase agreement with select accredited investors for up to USD 400 million in gross proceeds through a private placement. Pursuant to the terms of the purchase agreement, the company will issue an aggregate of 229,076,000 pre-funded warrants to purchase shares of the company's common stock at a price of $0.873 per pre-funded warrant, for upfront gross proceeds of USD 200 million.In addition, the company will issue warrants to purchase up to an aggregate of 229,076,000 shares of the company's common stock (or pre-funded warrants in lieu thereof) at an exercise price of $0.873 per share, for up to an additional USD 200 million in gross proceeds to Immunic. These warrants will expire upon the earlier of (a) 30 days after the public announcement of top-line data from the phase 3 ENSURE trials or (b) February 17, 2031. The private placement is expected to close on or about February 17, 2026, subject to customary closing conditions.The financing was led by existing investor BVF Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors.Leerink Partners acted as lead placement agent in connection with the financing. 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 in connection with the financing.The company intends to use the net proceeds from the offering to fund its clinical trials and operations and for other general corporate purposes. The proceeds from this private placement, combined with current cash, cash equivalents and marketable securities, are expected to fund operating and capital expenditures to late 2027.In addition, on February 12, 2026, Immunic entered into a purchase and sale agreement with certain holders of warrants to purchase shares of the company's common stock that were issued in its May 2025 public offering (the "Series B Warrants"). Pursuant to the terms of the purchase and sale agreement, the company issued to such holders the right to receive a portion of an aggregate 5% royalty on future net sales of vidofludimus calcium in exchange for cancellation of the Series B Warrants held by such participants. The purchase and sale agreement is expected to close on or about February 17, 2026.Further information regarding the private placement and the purchase and sale agreement can be found in the company's filings with the Securities and Exchange Commission, including a current report on Form 8-K which is expected to be filed on or about February 13, 2026.About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to consummation of the proposed offering and the exercise of warrants to be issued in the offering, Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process, the impact of competitive products and technological changes, the company's ability to close the proposed offering, and the risk that warrants issued in this offering will not be exercised for cash in the future. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.Contact InformationImmunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.comUS IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.comUS Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-announces-oversubscribed-private-placement-of-up-to-usd-400-million-to-accelerate-transformation-into-commercial-stage-company-302687546.htmlSOURCE Immunic, Inc.

Original: Immunic Announces Oversubscribed Private Placement of up to USD 400 Million to Accelerate Transformation into Commercial-Stage Company

IMUX...............................................https://stockcharts.com/sc3/ui/?s=IMUX&p=W&b=5&g=0&id=p86431144783

Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the ACTRIMS Forum 2026, Reinforcing Its Potential in Progressive Multiple SclerosisFebruary 4, 2026 6:30 AM
PR Newswire (US)

– Additional CALLIPER MRI Analyses Show Reductions for Vidofludimus Calcium in Acute and Chronic Inflammatory Disease Activity –– CALLIPER Subset Data Demonstrate Reductions in EBV-Specific T-Cell Receptor Sequences, Underlining Broad-Spectrum Antiviral Effects of Vidofludimus Calcium –NEW YORK, Feb. 4, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced the presentation of additional data from its phase 2 CALLIPER trial evaluating lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026, taking place from February 5-7, in San Diego, California. Both poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, members of Immunic's management, medical and preclinical teams will be available throughout the event at booth #N9."Together, our two poster presentations at the prestigious ACTRIMS Forum further underscore the unique mechanism of action of vidofludimus calcium and its potential in PMS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "These latest findings from our phase 2 CALLIPER trial 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 multiple sclerosis (MS) patients."Presentation Details:Poster Title: Effect of Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, on MRI Outcomes in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER TrialPresenting Author: Andreas Muehler, M.D., M.B.A., Chief Medical Officer of ImmunicAbstract Number: 555Poster Number: P130Poster Session: 1Session Date: Thursday, February 5, 2026Session Time: 5:45 pm – 7:30 pm PT (even-numbered posters present from 6:00-6:45 pm)MRI lesions in the brain of MS patients are commonly understood to be markers of acute-focal inflammation. In patients with PMS enrolled in the phase 2 CALLIPER trial, treatment with vidofludimus calcium was associated with improvements across key MRI markers of both acute-focal and chronic-compartmentalized inflammation when compared to placebo.The proportion of patients in the vidofludimus calcium group with gadolinium-enhancing (Gd+) lesions decreased from 16.4% at baseline (placebo: 16.4%) to 7.0% at week 72 (placebo: 11.7%) and 0% at week 120 (placebo: 2.9%). At week 72, the proportion of patients with new and/or enlarging T2 lesions was 18.5% for those in the vidofludimus calcium group vs. 30.0% for those in the placebo group. The difference in the mean change of T2 lesion volume in favor of vidofludimus calcium was statistically significant for weeks 48 (p

Looking at the past few years, still a loser of a stock, never thought it would break one dollar 

I've been there, but luckily not with this one. I found this one on "Openinsider", a website I started to check every day a few weeks ago, and so was able to get in at around 70 cents. 5 insiders bought shares in June, that's pretty much all I needed to know. I did check their profile and stats, comments on Yahoo finance as well. In looking over their 3 year chart I think we'll see $3. Just my opinion. Here's a link to open insider for IMUX: http://openinsider.com/search?q=imux

Still waiting for my break even, around the 1.80 mark

More upward price movement. Up 10% in two trading days.

SP moving up.

Up a nickle so far! Maybe this one is finally getting noticed? Now let's see if it sticks.

Reversing? Would like to see it up a nickle today.

Yea, like, what's up with that? This morning I was sure we were looking at a trend reverse, but now I'm not so sure.

And yet the price goes nowhere, would nice to see a price movement at some point 

News at 3:35am today: Immunic Reports New, Positive Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis. 92% of MS patients had no disability worsening after 3 years on lead oral drug.
https://finance.yahoo.com/news/immunic-reports-positive-long-term-103000989.html
On 5/29/25: D. Boral Capital analyst Jason Kolvbert maintains Immunic with a Buy and maintains $10 price target.

IMUX.............................................................................p/m

imux..............................................................................p/m

How low can this company go, never imagined this !!!

IMUX under $2

IMUX.......................https://stockcharts.com/h-sc/ui?s=IMUX&p=W&b=5&g=0&id=p86431144783

IMUX under $2

IMUX..............................................https://stockcharts.com/h-sc/ui?s=IMUX&p=W&b=5&g=0&id=p86431144783

$IMUX: Thank you.... I love cookies.

I'm on it now here............ $1.15


Lets go.




Wuz my name ?




GO $IMUX

imux...........https://stockcharts.com/h-sc/ui?s=IMUX&p=W&b=5&g=0&id=p86431144783

Anyways, anyone can explain this (IMUX) to me? Is made to control flare ups?
I like TSLA for progressive MS-- little broad immunosuppression

You are right on the FDA. Its an institution that massively hinders innovation. Lets say you are a sovereign patient and would like to take a certain compound that has already been well established in the clinic in a ph1 and ph2 study...... you might have to wait 5-8 years to finally use the product.

And yes they hold back some superior but cheaper therapies back..... Yet the desire to cure cancer is huge and often genuine. Its a big market opportunity after all too.

IMUX.......................https://stockcharts.com/h-sc/ui?s=IMUX&p=W&b=5&g=0&id=p86431144783

Well, thank you tw0122. All I did was go online and read that the Clevland Clinic cured patients with Stem Cells. The problem for many is the expense hence not being able to do it. I agree with you and also think about the COVID-19 vaccine. It's not a vaccine at all it's a shot where you need boosters every 6 months. A real vaccine you get once in a lifetime example is polio and SmallPox. and how many generations ago? So they did that like 130 years ago but they can't cure other killer diseases in the 21st century! BS!

Your one of the smart cookies out there. Big business almost cure cancer or just about any other ailment and then give you lifelong treatments and prescriptions. Legalized drug dealers

Amazingly, most people don't even know that stem cells cure MS, but I was cured at the Cleveland Clinic! You Can't use medical insurance it's all out of pocket! Big Pharms know all about this cure but will never approve because it will take billions of dollars out of their pocketbooks.It's a shame that the FDA is nothing more than a Govt Racket.👿

Amazingly, most people don't even know that stem cells cure MS, but I was cured at the Cleveland Clinic! You Can't use medical insurance it's all out of pocket! Big Pharms know all about this cure but will never approve because it will take billions of dollars out of their pocketbooks.It's a shame that the FDA is nothing more than a Govt Racket.👿

IMUX $1.83 + 16% Immunic Announces Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis

Source: PR Newswire (US)
– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met –

– IDMC Also Recommended Continuing Trial without Changes, Including no Need for a
Potential Upsizing –

– ENSURE Program Remains on Track to be Completed in 2026 –

– Webcast to be Held Today, October 22, at 8:00 am ET –

NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.

"While Immunic remains blinded to all data, the IDMC's favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line with the data observed so far," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. "In particular, the planned sample size seems appropriate to address the primary endpoint of time to first relapse. As the IDMC recommends, we are continuing the ENSURE trials unchanged, with completion expected in 2026."

"I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the program," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We are confident in vidofludimus calcium's potential to transform the oral MS market and continue to believe that the phase 3 program provides a clear and straightforward path towards seeking potential regulatory approval in RMS. Our next clinical milestone for vidofludimus calcium is the top-line readout of our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of next year. If this data set continues to show a neuroprotective effect for vidofludimus calcium, we believe our drug may be positioned as first-in-class oral treatment option for PMS, a form of MS with highest unmet medical needs."

The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with "futility criteria have not been met." The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with "continue as planned." Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations.

The ongoing 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, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale (EDSS) disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.

Webcast Information
Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_fSJNHWuxRMGRPaMl3hUlqg or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.

IMUX............................https://stockcharts.com/h-sc/ui?s=IMUX&p=W&b=5&g=0&id=p86431144783

Picked up 8K worth here today!

IMUX under $2