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

Immunic (Nasdaq: IMUX) announced that the European Patent Office granted patent EP3713554 covering label-relevant dosing regimens for vidofludimus calcium, protecting all forms (salts, solvates, free acid) in Europe into 2038.

Rhea-AI Summary

Immunic (Nasdaq: IMUX) announced that the European Patent Office granted patent EP3713554 covering label-relevant dosing regimens for vidofludimus calcium, protecting all forms (salts, solvates, free acid) in Europe into 2038. The patent may be eligible for an SPC to extend exclusivity potentially into 2043. The USPTO previously granted related protection in 2023; existing U.S. patents provide protection into 2041, and pending filings could extend certain rights into the mid-2040s.

Positive

• EPO granted patent EP3713554 covering dosing regimens
• Claims cover all forms: salt, solvate and free acid
• European protection expected into 2038 with possible SPC to 2043
• Existing U.S. patents provide protection into 2041
• Pending applications could extend protection into the mid-2040s

Negative

• SPC eligibility is conditional and not guaranteed
• Patent protection is time-limited, expiring in the 2038–2045 window
• No revenues, commercialization timeline, or financial guidance disclosed

Argus Mar 10 session

+3.20% close to close Open Argus

Details

News Market Reaction – IMUX

On Mar 10, the day this news came out, IMUX closed 3.20% above the previous close.

Data tracked by StockTitan Argus for the Mar 10 session.

Key Figures

US IP protection: into 2041 EU IP protection: into 2039 Patent EP3713554: EP3713554 +5 more

US IP protection

into 2041

Multi-layered strategy protection timeframe in the United States

EU IP protection

into 2039

Multi-layered strategy protection timeframe in Europe

Patent EP3713554

EP3713554

European patent number for vidofludimus dosing regimens

EU dosing patent

into 2038

Protection period in Europe for EP3713554

Potential SPC extension

into 2043

Supplementary Protection Certificate extension for Europe

Pending neurodegeneration IP

up to 2044

If applications on neurodegenerative uses are granted

Product formulation IP

up to 2045

If formulation/production/impurity profile patents are granted

USPTO grant year

2023

Year EP3713554’s US counterpart was granted by USPTO

Historical Context

5 past events · Latest: 2026-03-03

5 events

1. 2026-03-03

   Investor conferences

   24h Move

   +0.9%

   Announcement of participation in March investor conferences and webcasts.

2. 2026-02-26

   Earnings and update

   24h Move

   +4.1%

   Year-end 2025 results, major financing, and Phase 3/approval timeline update.

3. 2026-02-17

   Private placement close

   24h Move

   -4.4%

   Closing of oversubscribed private placement raising $200M upfront via warrants.

4. 2026-02-13

   Private placement deal

   24h Move

   +4.9%

   Announcement of up to $400M private placement to fund Phase 3 and transition.

5. 2026-02-04

   Clinical data update

   24h Move

   -5.4%

   Additional Phase 2 CALLIPER data showing significant MRI improvements in PMS.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

supplementary protection certificate, nurr1 activator, composition-of-matter, new chemical entity, +1 more

5 terms

supplementary protection certificate regulatory

"may be eligible for a Supplementary Protection Certificate (SPC), which could extend"

A supplementary protection certificate is a time-limited legal extension that lengthens patent protection for medicines or crop-protection products to compensate for years spent obtaining regulatory approval; it typically adds a few extra years of exclusive rights after the original patent term. For investors it matters because that extra exclusivity delays generic or competing products, often preserving a product’s sales and profits—similar to giving a best-selling item an extra warranty period before cheaper copies appear.

nurr1 activator medical

"lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium"

A nurr1 activator is a drug or compound designed to boost the activity of the Nurr1 protein, a cellular switch that helps maintain certain brain cells. Think of it as turning up a thermostat to restore normal cell function; for investors, such activators matter because they can form the basis of new therapies that, if clinically proven and approved, may create significant commercial value or trigger sharp changes in a developer’s stock based on trial results and regulatory milestones.

composition-of-matter technical

"composition-of-matter, indication, method-of-treatment, dosing, process of production"

A composition-of-matter is a legal description of a specific chemical or biological substance or mixture—think of it as the exact recipe and ingredients that make up a drug, material, or chemical product. For investors, ownership of a composition-of-matter patent can act like a locked recipe that keeps competitors out, protecting future sales and profit margins and reducing the risk that a product will be easily copied.

new chemical entity regulatory

"In addition to patent exclusivity, vidofludimus calcium, as a new chemical entity,"

A new chemical entity (NCE) is a drug whose active ingredient has never been previously approved or marketed; it’s a wholly new molecule rather than a new use of an existing compound. For investors, NCEs matter because they offer fresh commercial opportunities, potential patent and regulatory exclusivity, and correspondingly higher upside if successful — but they also carry greater development and regulatory risk, like betting on an untested recipe.

polymorph technical

"composition-of-matter of a specific polymorph of vidofludimus calcium and a related"

A polymorph is one of several different solid forms a single chemical compound can take when its molecules pack together differently, like how water can be ice or snow with different textures. For investors, polymorphs matter because they can change a drug’s stability, how quickly it dissolves in the body, manufacturing ease, and patent or regulatory strategies—factors that affect development costs, approval risk, and commercial value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– 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 Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

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SOURCE Immunic, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does EPO patent EP3713554 protect for Immunic (IMUX)?

It protects label-relevant dosing regimens of vidofludimus calcium across forms. According to the company, the claims cover vidofludimus and its salt, solvate and free acid forms when used per the label, limiting alternative-form workarounds.

When does the EPO patent for vidofludimus calcium expire for IMUX?

The EPO patent is expected to provide protection into 2038, possibly longer with SPC. According to the company, a Supplementary Protection Certificate could extend exclusivity potentially into 2043, subject to regulatory approval of the SPC.

How does this European patent relate to Immunic's U.S. patent protection (IMUX)?

The U.S. granted patents provide protection into 2041 for vidofludimus calcium. According to the company, the EPO grant complements U.S. composition, dosing and method patents to create a multi-layered exclusivity strategy.

Could pending patent applications extend IMUX exclusivity beyond current dates?

Yes, pending applications could extend protection if granted. According to the company, some pending filings could provide protection up to the mid-2040s, for example into 2044–2045, unless extended or otherwise modified.

What investor impact does the new European patent have for Immunic shareholders (IMUX)?

The patent strengthens the company’s intellectual property position for vidofludimus calcium. According to the company, the grant reinforces exclusivity durability, but no financial guidance, commercialization timeline, or revenue impacts were disclosed in the announcement.