Vidofludimus calcium

– 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: . 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 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 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo

– 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: . 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 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 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo