What changed in this filing

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Item 1. Business

2026-02-26 compared with 2025-03-31 · 324 added, 219 removed, 364 unchanged (60% of the section changed)

Immunic, Inc.

("Immunic," “we,” “us,” “our” or the "Company") is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases.

(“Immunic," “we,” “us,” “our” or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases.

We are headquartered in New York City with our main operations in Gräfelfing near Munich, Germany.

We had 91 employees as of March 1, 2025.

We had 92 employees as of February 1, 2026.

We are pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases.

These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 and Phase 2 clinical development for patients with relapsing and progressive multiple sclerosis (“MS”), respectively, and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS (“RRMS”), progressive MS and moderate-to-severe ulcerative colitis (“UC”);

the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease (“IBD”), Graft-versus-Host-Disease ("GvHD") and weight management;

and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.

These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with relapsing multiple sclerosis (“RMS”), and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis ("RRMS"), progressive multiple sclerosis (”PMS”) and other diseases;

and the IMU-381 program, which comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging our nuclear receptor-related 1 (“Nurr1”) platform.

The following table summarizes the potential indications, clinical targets and clinical development status of our three product candidates:

Our most advanced drug candidate, vidofludimus calcium (IMU-838), is being tested in several ongoing MS trials as part of its overall clinical program in order to support potential approvals for patients with MS in major markets.

The Phase 3 ENSURE program of vidofludimus calcium in relapsing multiple sclerosis (“RMS”), comprising twin studies evaluating efficacy, safety, and tolerability of vidofludimus calcium versus placebo, and the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (“PMS”), designed to corroborate vidofludimus calcium’s neuroprotective potential, are ongoing.

On October 9, 2023, we announced positive interim data from the CALLIPER trial, showing biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential.

Top-line data from the CALLIPER trial, for which the recruitment of 467 total patients was completed in August 2023, is expected to be available in April 2025.

Moreover, on October 22, 2024, we announced a positive outcome of an interim analysis of the ENSURE program, with an unblinded Independent Data Monitoring Committee ("IDMC") confirming that the predetermined futility criteria have not been met and recommending that both ENSURE trials should continue without changes, including no need for a potential increase of the sample size.

Completion of the first of the ENSURE trials is currently anticipated in the second quarter of 2026;

and the completion of the second ENSURE trial in the second half of 2026.

Although we currently believe that each of these goals is achievable, they are each dependent on numerous factors, most of which are not under our direct control and can be difficult to predict.

Our most advanced drug candidate, vidofludimus calcium (IMU-838), is being tested in ongoing multiple sclerosis (“MS”) trials as part of its overall clinical development program in order to support potential regulatory approvals for patients with MS in major markets.

The Phase 3 ENSURE program of vidofludimus calcium in RMS, comprising twin studies evaluating efficacy, safety, and tolerability of vidofludimus calcium versus placebo, is currently ongoing.

In October 2024, we announced a positive outcome of an interim analysis of the ENSURE program, with an unblinded Independent Data Monitoring Committee ("IDMC") confirming that the predetermined futility criteria have not been met and recommending that both ENSURE trials should continue without changes, including no need for a potential increase of the sample size.

In June 2025, we announced completion of enrollment for both ENSURE trials.

Each of the trials enrolled adult patients with active RMS at more than 100 sites in 15 countries.

In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo.

The top-line data for both ENSURE trials is expected by the end of 2026.

Although we currently believe that this goal is achievable, it is dependent on numerous factors, most of which are not under our direct control and can be difficult to predict.

We plan to periodically review this assessment and provide updates of material changes as appropriate.

Our Phase 2 CALLIPER trial of vidofludimus calcium in PMS was designed to corroborate vidofludimus calcium’s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of

PMS patients to determine the suitability of advancing to a confirmatory Phase 3 program.

In 2025, we announced the results from the CALLIPER trial, showing substantial and medically relevant reductions in 24-week confirmed disability progression (“24wCDW”) across patient populations and subgroups without evidence of focal inflammation;

substantial and statistically significant data regarding 24-week confirmed disability improvement (“24wCDI”);

and reductions in the annualized rate of thalamic brain volume loss and volume of new or enlarging T2 lesions.

The data also confirmed the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials.

If approved, we believe that vidofludimus calcium, with combined neuroprotective, anti-inflammatory, and antiviral effects as well as a favorable safety and tolerability profile, has the potential to be a unique treatment option targeted to the complex pathophysiology of MS.

Preclinical data showed that vidofludimus calcium activates the neuroprotective transcription factor nuclear receptor-related 1 (“Nurr1”), which is associated with direct neuroprotective properties and may enhance the potential benefit for patients.

Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (“DHODH”), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells.

Preclinical data showed that vidofludimus calcium activates the neuroprotective transcription factor Nurr1, which is associated with direct neuroprotective effects and may enhance the potential benefit for patients.

Additionally, vidofludimus calcium is a selective inhibitor of the enzyme dihydroorotate dehydrogenase (“DHODH”), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells.

This mechanism is associated with the anti-inflammatory and antiviral effects of vidofludimus calcium.

We believe that the combined mechanisms of vidofludimus calcium are unique in the MS space and support the therapeutic performance shown in our Phase 2 EMPhASIS trial in RRMS patients, in particular, via data illustrating the potential to reduce magnetic resonance imaging (“MRI”) lesions, prevent relapses, reduce the rate of disability progression, and reduce levels of serum neurofilament light chain (“NfL”), an important biomarker of neuronal damage.

Vidofludimus calcium has shown a consistent pharmacokinetic, safety and tolerability profile in clinical trials reported, to date, and has already been exposed to approximately 2,700 human subjects and patients in either of the drug’s formulations.

We believe that the combined mechanisms of vidofludimus calcium are unique in the MS space and support the therapeutic performance observed in our Phase 2 EMPhASIS trial in RRMS patients and in our Phase 2 CALLIPER trial in PMS patients.

Vidofludimus calcium has shown a consistent pharmacokinetic, safety and tolerability profile in clinical trials reported, to date, and has already been exposed to more than 3,400 human subjects and patients in either of the drug’s formulations.

IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (“SIRT6”), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium.

Based on preclinical data, we believe this compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, IBD, GvHD and other intestinal barrier function associated diseases.

Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance for patients during therapy, which would be an important advantage versus immunosuppressive medications and may allow the potential for combination with available treatments in gastroenterological diseases.

Data from a Phase 1b clinical trial in celiac disease patients during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology:

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IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing.

These two effects may indicate the potential for IMU-856 as an oral treatment option for weight management.

Contingent on financing, licensing or partnering, we are currently preparing clinical Phase 2 testing of IMU-856 in patients with ongoing active celiac disease (“OACD”) despite gluten-free diet, while also considering further potential clinical applications in other gastrointestinal disorders.

Immunic has selected IMU-381 as a development candidate to specifically address the needs of gastrointestinal diseases.

IMU-381 is a next generation molecule with improved overall properties, supported by a series of chemical derivatives.

IMU-381 is currently in preclinical testing.

Contingent on financing, licensing or partnering, we are currently preparing further clinical testing of IMU-856.

We have selected the IMU-381 program to leverage our Nurr1 platform for neurologic, gastrointestinal and other autoimmune diseases.

The platform comprises next-generation molecules, including a series of chemical derivatives, with improved overall properties.

The IMU-381 program is currently in preclinical testing.

Additional research and development activities remain ongoing through preclinical research examining the potential to treat a broad set of neuroinflammatory, autoimmune and viral diseases with new molecules leveraging our chemical and pharmacological research platform as well as generated intellectual property in these areas.

We are also exploring several options to possibly support further development of certain assets and technologies, including a potential spin-off into a new company and potential licensing transactions.

Through our wholly-owned subsidiary Gliomic Therapeutics Inc., we are pursuing the use of new compounds in brain cancers leveraging our expertise in DHODH inhibition.

We expect to continue to lead most of our research and development activities from our Gräfelfing, Germany location, where dedicated scientific, regulatory, clinical and medical teams conduct their activities.

Due to these teams' key relationships with local and international service providers, we anticipate that this should result in more timely and cost-effective execution of our development programs.

Due to these teams' key relationships with local and international service providers and academic partners, we anticipate that this should result in more timely and cost-effective execution of our development programs.

In addition, we are using our subsidiary in Melbourne, Australia to perform research and development activities in the Australasia region.

We also conduct preclinical work in our laboratory in Martinsried, Germany and in Halle/Saale, Germany through a collaboration with the Fraunhofer Institute.

We also conduct preclinical work in our laboratory in Martinsried, Germany and in Halle/Saale, Germany and through a collaboration with the Fraunhofer Institute.

Our business, operating results, financial condition and growth prospects are subject to significant risks and uncertainties, including delays in clinical trials, the failure of our clinical trials to meet their endpoints, failure to obtain regulatory approval and failure to obtain needed additional funding on acceptable terms, if at all, to complete the development and commercialization of our three development programs.

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• Executing the ongoing Phase 3 ENSURE clinical trials of vidofludimus calcium in RMS.

• Completing the Phase 2 CALLIPER clinical trial of vidofludimus calcium in PMS.

• Executing the IMU-856 development program, including preparation of a Phase 2 clinical trial.

• Determining appropriate next steps for vidofludimus calcium in PMS, following the successful completion of the Phase 2 CALLIPER clinical trial and feedback from healthcare authorities.

• Executing the IMU-856 development program, including preparation of additional clinical testing.

• Continuing preclinical research to complement the existing clinical activities, explore additional indications for potential future development and generating additional molecules for potential future development.

• Facilitating readiness for potential commercial launch of our product candidates through targeted and stage-appropriate pre-commercial activities.

• Facilitating readiness for potential commercial launch of our product candidates, if regulatory approvals are received, through targeted and stage-appropriate pre-commercial activities.

• Evaluating potential strategic collaborations for each product candidate in order to complement our existing research and development capabilities and to facilitate potential commercialization of these product candidates by taking advantage of the resources and capabilities of strategic collaborators in order to enhance the potential and value of each product candidate.

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We have no products approved for commercial sale and have not generated any revenue from product sales.

We have never been profitable and has incurred operating losses in each year since inception in 2016.

We have never been profitable and have incurred operating losses in each year since inception in 2016.

We have an accumulated deficit of approximately $608.6 million as of December 31, 2025 and $511.4 million as of December 31, 2024.

Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

We expect to incur significant expenses and increasing operating losses for the foreseeable future as we initiate and continue the development of our product candidates and add personnel necessary to advance our pipeline of product candidates.

We expect that our operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of development programs.

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As of December 31, 2025, we had cash and cash equivalents of approximately $15.5 million.

With these funds, we do not have adequate liquidity to fund our operations for at least twelve months from the issuance of these consolidated financial statements without raising additional capital, but such actions are not solely within the control of the Company.

If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether.

These factors raise substantial doubt about the Company’s ability to continue as a going concern.

On February 17, 2026, we announced the closing of a private placement with net cash proceeds of approximately $187.0 million.

With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.

Key Status Updates

Private Placement of up to $240 Million (the "January 2024 Financing")

On January 4, 2024, Immunic entered into a Securities Purchase Agreement with select accredited and institutional investors, pursuant to which the Company agreed to issue and sell to the Investors in a three-tranche private placement shares of the Company’s common stock, $0.0001 par value per share or in lieu thereof, pre-funded warrants to purchase shares of Common Stock.

The Pre-Funded Warrants are exercisable immediately for $0.0001 per share until exercised in full.

• The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.43 per share;

• The second tranche is a conditional mandatory purchase by the Investors of an additional $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.716 per share, equal to 120% of the price paid in the first tranche and is subject to the satisfaction of three conditions:

◦ release by the Company of topline data from its Phase 2b clinical trial of vidofludimus calcium (IMU-838) in progressive multiple sclerosis, which data is currently expected in or around April 2025;

◦ the 10-day volume-weighted average price of the Common Stock is at least $8.00 per share during the 6 months following the data release;

◦ aggregate trading volume during the same 10-day period is at least $100 million.

• The third tranche must occur no later than three years after the second tranche and is conditioned on the same volume-weighted average share price and minimum trading volumes as the second tranche.

The third tranche provides for the issuance of $80 million of shares of common stock (or pre-funded warrants) at the same price per share as the second tranche, but permits investors to fund their purchase obligations on a “cashless” or net settlement basis, which would reduce the cash proceeds to be raised by the Company in the January 2024 Financing.

Any of the conditions in the second or third tranches can be waived by holders of a majority of the outstanding securities (including the lead investor).

The fair value methodology used by the Company assumed the conditions will be waived if the trading price of the stock exceeds the purchase price.

The January 2024 Financing resulted in gross proceeds to the Company of approximately $80 million in the first tranche, and an additional $80 million if and when the second tranche occurs.

If the second tranche is completed and conditions for the third tranche are satisfied or waived, the Company could receive up to an additional $80 million in the third tranche.

However, the amount of cash received in the third tranche would depend on the extent to which the Investors elect to fund the third tranche through a “cashless” or net settlement basis.

Therefore, total gross proceeds from the offering to the Company could actually be between $80 million and $240 million.

Gross proceeds to the Company will be reduced by fees paid to the placement agents, capital markets advisors and payments of transaction expenses.

The Company intends to use the net proceeds from the January 2024 Financing to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-856 and IMU-381, and for other general corporate purposes.

As of the closing date of the transaction of January 8, 2024, the Company did not have enough authorized shares to be able to issue the potential shares for tranche 2 and tranche 3 (collectively referred to hereafter as "the tranche rights").

Therefore, the Company recorded the value associated to the tranche rights as a liability of $23.6 million and allocated the remainder of the $80 million received (or approximately $56.4 million) from the common stock and pre-funded warrants to equity.

On March 4, 2024, at a special meeting of stockholders, the stockholders voted to increase the Company's authorized common shares from 130 million to 500 million shares.

As a result of the ability to issue shares in satisfaction of the tranche rights, the instrument was reclassified to stockholders' equity.

The Company allocated the transaction cost across the instruments on a relative fair value basis.

As a result, $4.0 million was netted against the equity proceeds and $1.7 million was recorded in other expense in the Consolidated Statements of Operations for the year ended December 31, 2024.

The January 2024 Financing was led by BVF Partners L.P., and included participation from new and existing investors, including Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners LP.

Leerink Partners acted as the lead placement agent and Ladenburg Thalmann acted as a placement agent in connection with the offering.

Piper Sandler, B.

Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as capital markets advisors to the Company.

The Company registered for resale by the investors in the January 2024 Financing up to 55,944,850 shares of common stock issued (or issuable upon exercise of pre-funded warrants) in the first tranche.

The Company will not receive any proceeds from the sale of these shares of common stock.

These shares are registered on a registration statement on Form S-3 (registration No.

333-277040), which was declared effective by the SEC on April 30, 2024.

Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States

On March 20, 2024, we announced Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for patent application 16/981,122, entitled, “Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents,” covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material.

The claims are expected to provide protection into 2041, unless extended further.

The patent was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico.

Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS in the Peer Reviewed Journal, Neurology ® Neuroimmunology & Neuroinflammation

On April 30, 2024, we announced that data from our Phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS has been published online on April 25, 2024 in Neurology ® Neuroimmunology & Neuroinflammation , an official journal of the American Academy of Neurology.

The paper, lead authored by coordinating investigator, Robert J.

Fox, M.D., Staff

Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, is entitled, “Safety and Dose-Response of Vidofludimus Calcium in Relapsing Multiple Sclerosis:

Extended Results of a Placebo-Controlled Phase 2 Trial.”

Appointment of Jason Tardio as Chief Operating Officer and President and Promotion of Werner Gladdines to Chief Development Officer

On July 9, 2024, we announced that seasoned biopharmaceutical executive, Jason Tardio, will be joining the company as Chief Operating Officer and President, effective July 12, 2024.

In the newly created role, Mr.

Tardio leads internal efforts to prepare for the potential launch of vidofludimus calcium.

Jason also works closely with Patrick Walsh, Chief Business Officer, to prepare the Company for a range of potential partnership outcomes for vidofludimus calcium, as well as our other drug candidates.

On July 9, 2024, we also reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, has been promoted to Chief Development Officer.

In his new role, Mr.

Gladdines takes over additional strategic and operational responsibility for our overall clinical operations functions.

Appointment of Simona Skerjanec to Board of Directors

On July 24, 2024, we announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience in drug development and commercialization, as a member of our Board of Directors, effective as of July 22, 2024.

As a Class I director, Ms.

Skerjanec’s term lasts until the Company’s 2027 annual meeting of stockholders.

First Patient Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of Vidofludimus Calcium in Patients with Post COVID Syndrome

On September 4, 2024, we announced enrollment of the first patient in an investigator-sponsored Phase 2 clinical trial of vidofludimus calcium, entitled, “Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE).” The Phase 2 RAPID_REVIVE trial, for which Immunic is providing study medication, is a randomized, placebo-controlled, double-blind, parallel group trial sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research.

Hosted Two Multiple Sclerosis R&D Days in New York City and San Francisco

At two MS R&D Days, on September 10, 2024 in New York City and on April 9, 2024 in San Francisco, management discussed the latest developments in the MS landscape, along with recent mode of action, preclinical and clinical data supporting the combined neuroprotective, anti-inflammatory and antiviral profile of vidofludimus calcium.

Presented Key Vidofludimus Calcium Data at the 40th Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple Sclerosis

On September 18, 2024, we announced the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (“ECTRIMS”), highlighting vidofludimus calcium’s therapeutic potential in MS.

The data was presented in an oral poster presentation and three ePosters at this conference in Copenhagen, Denmark.

Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis

On October 22, 2024, we announced a positive outcome of an interim analysis of our Phase 3 ENSURE program, investigating vidofludimus calcium for the treatment of RMS.

An unblinded IDMC confirmed that the predetermined futility criteria have not been met and recommended that both ENSURE trials should continue without changes.

The IDMC considered if a sample size adjustment would be appropriate for either of the two trials based on factors that include statistical analysis and ultimately recommended that the sample sizes for both trials should remain unchanged.

Announced Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology

On November 13, 2024, we announced that the data from our Phase 1/1b clinical trial of IMU-856, has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology .

Lead authored by Dr.

James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, “Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease:

a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.”

February 2026 Private Placement

Securities Purchase Agreement

On February 12, 2026, we into a securities purchase agreement (the “February Securities Purchase Agreement”) with certain accredited investors (the “February Investors”), pursuant to which we agreed to issue and sell, in a private placement (the “February 2026 Offering”), pre-funded warrants (the “February 2026 Pre-Funded Warrants”, and the shares of Common Stock issuable upon exercise of the February 2026 Pre-Funded Warrants, the “February 2026 Pre-Funded Warrant Shares”) to purchase up to 0.0001 shares of Common Stock, with each February 2026 Pre-Funded Warrant accompanied by a warrant to purchase (i) a share of Common Stock or (ii) a pre-funded warrant to purchase a share of Common Stock (collectively, the “February 2026 Common Warrants” and together with the February 2026 Pre-Funded Warrants, the “February 2026 Warrants”, and the shares of Common Stock issuable upon exercise of the February 2026 Common Warrants, the “February 2026 Common Warrant Shares”, and together with the February 2026 Pre-Funded Warrant Shares, the “February 2026 Warrant Shares”).

The purchase price for each February 2026 Pre-Funded Warrant and accompanying February 2026 Common Warrant was $0.873120.

Each February 2026 Pre-Funded Warrant is immediately exercisable at a price of $0.0001 per share.

Each February 2026 Common Warrant is exercisable at a price $0.873220 per share (subject to adjustment as set forth therein) following the completion of the Reverse Stock Split (as defined below) until the earlier of (i) 30 trading days following the date of our initial public announcement of topline data from its Phase 3 ENSURE trials (for the avoidance of doubt, the later date of the initial public announcement of topline data from ENSURE-1 or ENSURE-2, if announced separately) (the “Topline Data Announcement”), (ii) immediately upon the exercise of the February 2026 Pre-Funded Warrants if such exercise of February 2026 Pre-Funded Warrants is prior to the Topline Data Announcement, provided that if the February 2026 Pre-Funded Warrant is not exercised in full, the February 2026 Common Warrant expires proportionally only to the extent the Pre-Funded Warrant is exercised, and (iii) February 17, 2031.

The Offering closed on February 17, 2026 (the “February 2026 Closing Date”).

The aggregate gross proceeds to the Company from the issuance and sale of the February 2026 Warrants was approximately $200 million, before deducting fees to be paid to the placement agents and financial advisors of the Company and other estimated offering expenses payable by the Company.

The aggregate exercise price of the February 2026 Warrants is approximately $200 million.

Leerink Partners LLC acted as lead placement agent for the Offering, Stifel, Guggenheim Securities, William Blair, LifeSci Capital, B.

Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC also acted as placement agents for the February 2026 Offering.

As compensation in connection with the February 2026 Offering, we agreed to pay the placement agents a fee equal to 6% of the aggregate gross proceeds received by us (i) upon the issuance of the February 2026 Warrants at closing and (ii) upon the cash exercise of the February 2026 Common Warrants.

We intend to use the net proceeds from the February 2026 Offering to fund our clinical trials and operations and for working capital and other general corporate purposes.

The securities issued in the February 2026 Offering have not been registered under the Securities Act, and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration.

There is no established public trading market for the February 2026 Warrants, and we do not intend to list such securities on any national securities exchange or nationally recognized trading system.

In connection with the February 2026 Offering, we and each February 2026 Investor entered into a registration rights agreement simultaneously with the February 2026 Securities Purchase Agreement (the “February 2026 Registration Rights Agreement”).

Pursuant to the February 2026 Registration Rights Agreement, as promptly as reasonably practicable following the February 2026 Closing Date but, in any event, not later than 45 days thereafter (the “Filing Date”) we shall file a resale registration statement on Form S-3 (or Form S-1 if Form S-3 is not available) providing for the resale by the Investors of the Registrable Securities (as defined in the February 2026 Registration Rights Agreement) and to use reasonable best efforts to cause such resale registration statement to be declared effective by the staff of the Securities and Exchange Commission (the “SEC”) at the earliest possible date but no later than the earlier of (a) the 60th calendar day following the Filing Date if the SEC notifies us that it will review the registration statement and (b) the fifth business day after we are notified by the SEC that the registration statement will not be “reviewed” or will not be subject to further review or (ii) the fifth business day following the receipt of Reverse Split Stockholder Approval (as defined below) and the consummation of the Reverse Stock Split.

The February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement contain certain representations and warranties, covenants and indemnities customary for similar transactions.

The representations, warranties and covenants contained in the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement were made solely for the benefit of the parties to the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement, respectively, and may be subject to limitations agreed upon by the contracting parties.

Special Meeting and Reverse Stock Split

The February 2026 Securities Purchase Agreement provides that no later than three days following the February 2026 Closing Date, we must file a preliminary proxy statement with the SEC for the purpose of receiving stockholder approval (“Reverse Split Stockholder Approval”) of an amendment to our certificate of incorporation to effect a reverse stock split of the Company’s issued and outstanding Common Stock, at a ratio of not less than 10:1 (the “Reverse Stock Split”).

The Company filed this proxy statement on February 20, 2026.

Royalty Purchase Agreement

As previously disclosed, on June 3, 2025, the Company issued series B common stock warrants to purchase up to an aggregate of 86,666,667 shares of Common Stock (or prefunded warrants to purchase shares of Common Stock) in an underwritten public offering (the “Series B Warrants”).

On February 12, 2026, the Company entered into a purchase and sale agreement (the “Royalty Purchase Agreement”) with certain Series B Warrant holders who had purchased a predetermined number of Series B Warrants (each a “Participating Series B Holder”) and BVF Partners, L.P.

(“BVF”), acting as royalty interest agent (the “Warrant Exchange”).

Pursuant to the Royalty Purchase Agreement, the Participating Series B Holders will exchange an aggregate of 51,087,000 Series B Warrants for a pro rata share of an aggregate 5% synthetic royalty on future sales of the Company’s vidofludimus calcium program in any country (the “Royalty Interests”).

The pro rata share for each Participating Series B Holder is equal to the number of Series B Warrants exchanged by such Participating Series B Holder divided by the number of Series B Warrants exchanged by all Participating Series B Holders (expressed as a percentage).

Royalty Interests will be due and payable quarterly by the Company to the Participating Series B Holders following the First Commercial Sale (as defined in the Royalty Purchase Agreement).

Pursuant to the Royalty Purchase Agreement, the Company has agreed to specified affirmative and negative covenants, including without limitation covenants regarding periodic reporting of information by the Company to the Participating Series B Holders, and audits of royalties paid under the Royalty Purchase Agreement.

The Royalty Purchase Agreement also contains representations and warranties, other covenants, indemnification obligations, and other provisions customary for transactions of this nature.

On the Closing Date, Series B Warrants to purchase up to an aggregate of 51,087,000 shares of Common Stock were surrendered by Participating Series B Holders and cancelled, and Series B Warrants to purchase up to an aggregate of 35,579,667 shares of Common Stock remain issued and outstanding.

Changes to the Board of Directors – Appointment of Director

On February 12, 2026, our board of directors (the “Board”), following the recommendation of the Nominating and Corporate Governance Committee of the Board (the “Committee”), appointed Thor Nagel, an Analyst with BVF, to the Board until the 2026 annual meeting of stockholders as a Class III director or until his respective successors are duly elected and qualified.

Changes to the Board of Directors – Appointment of Chair

On February 12, 2026, following the recommendation of the Committee, the Board appointed Simona Skerjanec, a member of the Board since July 2024, to serve as Interim Chairperson of the Board.

Duane Nash, former Chairman, remains a member of the Board.

Changes to the Board of Directors – Resignation of Director

On February 12, 2026, Maria Törnsén resigned as a member of the Board in connection with the February Offering.

The resignation of Ms.

Törnsén was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

The Board and the Company are deeply grateful for Ms.

Törnsén’s service, dedication, and contributions to the Company.

Our Co-Founder and Chief Executive Officer, Dr.

Daniel Vitt, and the Board will begin a search for a new CEO with deep commercial expertise in the MS space to lead Immunic through its next stage of growth and into commercialization.

Subsequently, Dr.

Vitt plans to transition to a new senior executive role focused on strengthening the company's scientific strategy and driving portfolio advancement.

He will continue to support the organization in this capacity and as a member of the Board of Directors.

Presented Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the ACTRIMS Forum 2026

On February 4, 2026, we announced the presentation of additional data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the Americas Committee for Treatment and Research in Multiple Sclerosis (“ACTRIMS”) Forum 2026.

The findings presented in two poster presentations provide additional evidence of vidofludimus calcium’s effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (“EBV”)

and magnetic resonance imaging (“MRI”) markers of both acute-focal and chronic-compartmentalized inflammation.

The findings further reinforce our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.

Presented Key Vidofludimus Calcium Data at the 41st Congress of ECTRIMS, Highlighting Its Potential in MS

On September 24, 2025, we announced presentations of key vidofludimus calcium data at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (“ECTRIMS”).

The results from our Phase 2 CALLIPER trial in PMS, also selected for the Best of ECTRIMS 2025 slide deck, highlighted vidofludimus calcium's neuroprotective potential and its promise to slow disease progression in patients with or without focal inflammation.

Importantly, the consistent 24wCDW results across patient populations and subgroups, including in patients without evidence of baseline inflammatory gadolinium-enhancing (“Gd+”) lesions during MRI, were seen both in the overall population and in the primary progressive multiple sclerosis (“PPMS”) and non-active secondary progressive multiple sclerosis (“naSPMS”) subgroups.

Additionally, data regarding 24wCDI showed an over two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across the subtypes.

The CALLIPER findings support our hypothesis of clinically measurable neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism.

We believe that, since 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS, this evidence of clinical activity merits further investigation and de-risks a potential Phase 3 program.

Moreover, at ECTRIMS, we also presented additional long-term data from the open-label extension (“OLE”) period of our Phase 2 EMPhASIS trial in RRMS which further reinforced the robust efficacy signals and favorable safety and tolerability observed, to date.

The long-term EMPhASIS OLE data demonstrated that vidofludimus calcium was well-tolerated in patients with RRMS for treatment durations of up to 5.5 years.

Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled approximately 952 treatment years, with an annualized discontinuation rate of only approximately 6.4%.

The most common treatment-emergent adverse events were mild, with low rates of renal and liver-related events and no new safety signals observed.

Serious adverse events were infrequent and none were deemed related to treatment.

These results suggest a favorable long-term safety and tolerability profile for vidofludimus calcium in RRMS.

Received Notice of Allowance from the United States Patent and Trademark Office Protecting Vidofludimus Calcium's Dose Strengths in PMS

On September 9, 2025, we announced that we received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for patent application 18/529,946, entitled "Treatment of multiple sclerosis comprising DHODH inhibitors." Specifically, the resulting patent covers dose strengths associated with vidofludimus calcium and other salt forms as well as free acid forms, at a daily dose of about 10 mg to 45 mg, for the treatment of PMS, including the sub-groups PPMS and secondary progressive multiple sclerosis (“SPMS”).

The patent is expected to provide protection into 2041, and a potential Patent Term Extension may offer additional market exclusivity in the United States.

Allowance of this new key patent represents a significant advancement for vidofludimus calcium program in PMS and further strengthens its robust, multi-layered intellectual property portfolio.

New, Positive Long-Term Open-Label Extension Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS

On June 24, 2025, we announced new long-term OLE data from our Phase 2 EMPhASIS trial in patients with RRMS.

The data at week 144 showed that 92.3% of patients remained free of 12wCDW, and 92.7% free of 24wCDW.

A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144.

Of these, 44.8% were associated with relapse-associated worsening (“RAW”), while only 13.8% were associated with progression independent of relapse activity (“PIRA”).

Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforces the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of treatment-emergent and serious adverse events.

Importantly, no new safety signals have emerged during treatment durations up to 5.5 years.

The Phase 2 EMPhASIS trial in RRMS includes an optional OLE period for up to 9.5 years to evaluate long-term safety and tolerability of vidofludimus calcium.

Of the 268 patients that started the double-blind main treatment period, 254 patients continued in the OLE period.

At the time of data cutoff on January 14, 2025, 182 patients (71.6% of patients starting OLE) were evaluated up to week 144, which translates into approximately 952 overall treatment years.

Completion of Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in RMS

On June 5, 2025, we announced completion of enrollment for both Phase 3 ENSURE trials.

The ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients.

Each of the trials, titled ENSURE-1 and ENSURE-2,

enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa (“MENA”) region, Latin America, and Central and Eastern Europe.

In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo.

The primary endpoint for both trials is time to first relapse up to 72 weeks.

Secondary endpoints include time to confirmed disability worsening based on the expanded disability status scale ("EDSS"), volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and MRI-based endpoints.

The top-line data from both ENSURE trials is expected by the end of 2026, which should allow for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint.

Additional Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in PMS

On June 5, 2025, we also announced additional data from our Phase 2 CALLIPER trial in PMS, further supporting the positive top-line results announced on April 30, 2025.

Building on the top-line data showing reductions in the relative risk of 24wCDW events based on the EDSS at the end of the main treatment period, data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforced the neuroprotective potential of vidofludimus calcium in the overall PMS patient population and in the PPMS, naSPMS and active secondary progressive multiple sclerosis (“aSPMS”) subtypes.

Similarly, consistent with the top-line data, further analyses of subpopulations – both with and without inflammatory gadolinium-enhanced lesion activity at baseline, who are largely shown to not benefit from current anti-inflammatory therapies – continued to demonstrate promising results for the overall study population as well as the PPMS and naSPMS subtypes.

Vidofludimus Calcium Reduced Risk of Disability Worsening in Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial

On April 30, 2025, we announced the results from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS.

In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24wCDW events based on changes in the EDSS compared to placebo.

Further analyses by disease subtype demonstrated that vidofludimus calcium was associated with similar reductions in the relative risk of 24wCDW events in the PPMS and the naSPMS study populations compared to placebo.

A consistent reduction of disability worsening was observed in the different subpopulations with or without inflammatory gadolinium-enhanced lesion activity at baseline and during the study.

Vidofludimus calcium reduced the relative risk of 24wCDW events in patients without gadolinium-enhancing lesions at baseline compared to placebo.

While vidofludimus calcium had a modest benefit on the exploratory primary MRI endpoint, it substantially reduced the annualized rate of thalamic brain volume loss in patients with PMS compared to placebo.

The total volume of new or enlarging T2 lesions showed a substantial difference between vidofludimus calcium and placebo over time, with vidofludimus calcium decreasing and placebo increasing.

The top-line CALLIPER data set supports the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials.

No new safety signals were identified.

IMU-856 Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing

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IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing.

These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.

The post hoc analysis of our Phase 1b clinical trial of IMU-856 in celiac disease patients measured blood concentrations of GLP-1, between baseline and day 28, in a fasting state.

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These clinical findings were corroborated by effects observed in a 6-month preclinical in vivo study, where IMU-856 was found to reduce body weight gain accompanied by food consumption in a dose-dependent fashion up to -40 %, compared to the control group, which was found to be linked to reduced food intake.

April 2025 Offering

On April 9, 2025, we entered into a securities purchase agreement with certain institutional and accredited investors relating to the issuance and sale of an aggregate of 5,666,667 shares of our Common Stock (the “April 2025 Shares”).

The purchase price per share was $0.90 for aggregate gross proceeds of approximately $5.1 million.

The offer and sale of the shares is referred to herein as the “April 2025 Offering.” The April 2025 Offering closed on April 10, 2025.

In addition, on April 9, 2025, the Company entered into a placement agency agreement with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Placement Agent”), relating to the April 2025 Offering.

Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 6.0% of the gross proceeds from the April 2025 Offering raised from investors and to reimburse the Placement Agent for certain costs incurred in connection therewith.

Additionally, upon the closing of the April 2025 Offering, the Company agreed to issue to the Placement Agent, or its designees, warrants to purchase up to an aggregate of 283,334 shares of common stock, representing 5.0% of the shares sold in the April 2025 Offering (the “Placement Agent Warrants”).

The Placement Agent Warrants are exercisable, in whole or in part, for five years from the anniversary of the Placement Agency Agreement, at an initial exercise price per share of common stock of $1.125, which is equal to 125% of the price per share to investors in the April 2025 Offering.

The Placement Agent Warrants and the shares of common stock underlying the Placement Agent Warrants were offered pursuant to the exemptions from registration provided in Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder.

The net proceeds to the Company from the April 2025 Offering, after deducting commissions and the Company’s offering expenses, was approximately $4.7 million.

The April 2025 shares were registered under the Securities Act, on the Company’s Registration Statement on Form S-3 (Registration No.

333-275717), previously filed with the SEC, and declared effective on May 31, 2024.

May 2025 Equity Offering

On May 28, 2025, we entered into an underwriting agreement (the “May 2025 Underwriting Agreement”) with Leerink Partners LLC, for the issuance and sale of (i) pre-funded warrants to purchase an aggregate of 86,666,667 shares of Common stock (the “May 2025 Pre-Funded Warrants”), (ii) accompanying series A warrants to purchase an aggregate of 86,666,667 shares of Common Stock (or Pre-Funded Warrants) (the “Series A Warrants”), and (iii) accompanying series B warrants to purchase an aggregate of 86,666,667 shares of Common Stock (or Pre-Funded Warrants) (the “Series B Warrants”) (the “May 2025 Offering”).

The price per May 2025 Pre-Funded Warrant and accompanying Series A Warrant and Series B Warrant was $0.7499.

Each Pre-Funded Warrant is immediately exercisable for one share of Common Stock at an exercise price of $0.0001 per share and will expire when exercised in full.

The Series A Warrants are exercisable for one share of Common Stock at an exercise price of $0.75 per share.

All but 10,666,667 of the Series A Warrants expired on December 31, 2025.

The expiration date for the remaining 10,666,667 Series A Warrants was extended to February 28, 2026.

Each Series B Warrant is exercisable on the earlier of (i) October 1, 2025, (ii) the first day following any five trading days during which the volume weighted average price for the Common Stock of the Company during such five trading day period is $1.25 or greater (the “VWAP Target”), or (iii) immediately prior to the consummation of a Fundamental Transaction (as defined in the Series B Warrants) for one share of Common Stock at an exercise price of $0.75 per share and will expire five years from the date of issuance.

The holder of the Pre-Funded Warrants and Series B Warrants may also satisfy its obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of such warrant in shares of Common Stock determined according to the formula set forth in the applicable warrant.

The aggregate proceeds from the May 2025 Offering were approximately $65 million before deducting underwriting discounts and commissions and offering expenses payable by the Company in connection with the May 2025 Offering.

On February 12, 2026, as part of the Royalty Purchase Agreement, 51,087,000 warrants were exchanged for the right to share a 5% royalty and 35,579,667 Series B warrants are still outstanding (see note 12 "Subsequent events").

The Company may receive up to an aggregate of approximately $27 million of additional gross proceeds if the remaining Series B Warrants are exercised in full for cash and up to $8.0 million gross proceeds if the remaining Series A Warrants are exercised for cash.

Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 6.0% of the gross proceeds from the May 2025 Offering raised from investors and to reimburse the Placement Agent for certain costs incurred in connection therewith.

The May 2025 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No.

333-275717), as amended, previously filed with the SEC on November 22, 2023, and declared effective by the SEC on May 31, 2024, as supplemented by the preliminary prospectus supplement, dated May 28, 2025, and a final prospectus supplement filed with the SEC pursuant to Rule 424(b) under the Securities Act, on May 30, 2025.

The closing of the May 2025 Offering took place on June 3, 2025.

Transfer of Nasdaq Market Listing and Notice of Non-Compliance with Nasdaq Listing Rule 5450(a)(1)

On January 5, 2026, we were notified by the Nasdaq Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that our application to transfer the listing of our Common Stock from the Nasdaq Global Select Market to the Nasdaq Capital Market had been approved (the “Approval”).

The common stock was transferred to the Nasdaq Capital Market at the opening of business on January 7, 2026.

The common stock will continue to trade under the symbol “IMUX.” The Nasdaq Capital Market operates in substantially the same manner as the Nasdaq Global Select Market, and listed companies must meet certain financial requirements and comply with Nasdaq’s corporate governance requirements.

As previously disclosed, on June 27, 2025, we received a letter from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1) because the closing bid price per share for Common Stock had closed below $1.00 for the previous 30 consecutive business days (the “Bid Price Rule”).

We were given a 180-day grace period, until December 24, 2025, to regain compliance with the rule.

We had not regained compliance with the Bid Price Rule by December 24, 2025.

Therefore, we transferred the listing of our Common Stock from the Nasdaq Global Select Market to the Nasdaq Capital Market.

As a result of the Approval, we have been granted an additional 180-day grace period, or until June 22, 2026, to regain compliance with the Bid Price Rule.

To regain compliance with the Bid Price Rule and qualify for continued listing on the Nasdaq Capital Market, the minimum bid price per share of the Common Stock must be at least $1.00 for at least 10 consecutive business days on or prior to June 22, 2026.

If we fail to regain compliance during the additional compliance period, then Nasdaq will notify us of its determination to delist the Common Stock, at which point we would have an opportunity to appeal the delisting determination to a Nasdaq Listing Qualifications Panel (the “Panel”), but there can be no assurance that the Panel would grant our request for continued listing.

As a condition of the Approval imposed by Nasdaq Listing Rule 5810(c)(3)(a)(i), we notified Nasdaq that it would seek to implement a reverse stock split, if necessary, to regain compliance with the Bid Price Rule.

The Company filed a proxy statement to obtain shareholder approval for a reverse stock split on February 20, 2026.

Product Acquisition History

Our wholly-owned German subsidiary Immunic AG acquired vidofludimus calcium and izumerogant in September 2016 through asset acquisitions from 4SC AG (hereinafter, “4SC”), a publicly traded company based in Planegg-Martinsried, Germany.

Our wholly-owned German subsidiary Immunic AG acquired vidofludimus calcium in September 2016 through an asset acquisition from 4SC AG (hereinafter, “4SC”), a publicly traded company based in Planegg-Martinsried, Germany.

On March 31, 2021, Immunic AG and 4SC entered into a Settlement Agreement, pursuant to which Immunic AG settled its remaining obligation of a 4.4% royalty on net sales for $17.25 million.

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We are led by a team of dedicated and committed experienced professionals with an entrepreneurial spirit and track record of successful licensing transactions in the healthcare industry, worldwide.

The team brings together several decades of leadership experience in the pharmaceutical industry with a strong scientific background and sound knowledge in drug discovery, product development, chemistry, manufacturing and controls processes, intellectual property, clinical trial design, health economics and market access, merger and acquisitions, capital markets, corporate finance, business development, regulatory affairs and project valuation.

The team brings together several decades of leadership experience in the pharmaceutical industry with a strong scientific background and sound knowledge in drug discovery, product development, chemistry, manufacturing and controls processes, intellectual property, clinical trial design, health economics and market access, commercial launch, merger and acquisitions, capital markets, corporate finance, business development, regulatory affairs and project valuation.

Our team members are inventors on project-related patents and have successfully published project-related scientific publications.

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Nurr1 activation mediates its neuroprotective function by acting in microglia, astrocytes and neurons.

In microglia and astrocytes, Nurr1 activation leads to a reduction of pro-inflammatory cytokines and blocks the production of direct neurotoxic agents like reactive oxygen species (“ROS”) and nitric oxide (“NO”).

In microglia and astrocytes, Nurr1 activation leads

to a reduction of pro-inflammatory cytokines and blocks the production of direct neurotoxic agents like reactive oxygen species (“ROS”) and nitric oxide (“NO”).

Enhanced Nurr1 activity in neurons mediates neuronal survival and differentiation, as well as improved neurotransmission.

Therefore, activation of Nurr1 by vidofludimus calcium may halt neurodegeneration and disability progression in patients suffering from MS and other degenerative diseases.

Additionally, vidofludimus calcium is a known inhibitor of the enzyme DHODH, which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells.

Additionally, vidofludimus calcium is a selective inhibitor of the enzyme DHODH, which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells.

This mechanism is associated with the anti-inflammatory and antiviral effects of vidofludimus calcium.

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By addressing only highly metabolically active immune cells, vidofludimus calcium may reduce focal inflammation in the brain, without impacting normal acting immune cells.

Based on the selectivity toward metabolically activated cells (with a high need for ribonucleic acid and deoxyribonucleic acid production), DHODH inhibition also leads to a direct antiviral effect, which has been observed in various virus infected cells, such as Epstein-Barr virus (“EBV”) infections, hepatitis C virus infections, severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”) infections, cytomegalovirus infections and even hemorrhagic fever-causing viruses, such as Arena virus infections.

Based on the selectivity toward metabolically activated cells, with a high need for ribonucleic acid and deoxyribonucleic acid production, DHODH inhibition also leads to a direct antiviral effect, which has been observed in various virus infected cells, such as EBV infections, hepatitis C virus infections, severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”) infections, cytomegalovirus infections and even hemorrhagic fever-causing viruses, such as Arena virus infections.

Treatment with vidofludimus calcium may avoid virus infections and reactivations, one of the major drawbacks of the long-term use of traditional immunomodulators.

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Previous filings by us with the SEC have summarized the development history of vidofludimus and the previous amorphous formulation of the free acid form of vidofludimus.

After the consummation of the asset acquisition from 4SC, we developed and filed several new patent applications for a new specific polymorph of the calcium salt formulation of vidofludimus, vidofludimus calcium, which we believe exhibits improved physicochemical and pharmacokinetic (“PK”) properties.

After the asset acquisition from 4SC, we developed and filed several new patent applications for a new specific polymorph of the calcium salt formulation of vidofludimus, vidofludimus calcium, which we believe exhibits improved physicochemical and pharmacokinetic (“PK”) properties.

In 2017, we completed two Phase 1 studies of single or repeated once-daily doses of vidofludimus calcium in healthy human subjects, where we observed results supporting tolerability of repeated daily dosing of up to 50 mg of vidofludimus calcium.

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The study showed little influence on the PK of vidofludimus calcium in patients with Child-Pugh A Child-Pugh B liver impairment.

Currently, several clinical pharmacology studies and related analyses are ongoing that are intended to support regulatory filings of vidofludimus calcium.

Multiple Sclerosis

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During remissions, all symptoms may disappear, or some symptoms may continue and become permanent.

PMS includes both primary progressive MS (“PPMS”), and secondary progressive MS (“SPMS”).

PMS includes primary progressive MS (“PPMS”) and secondary progressive MS (“SPMS”).

PPMS is characterized by steadily worsening neurologic function from the onset of symptoms without initial relapse or remissions.

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Evolution in Understanding of Disease Drivers of MS

The presence of a “smoldering disease” in the background of MS that leads to progression independent of relapse activity (“PIRA”) was suggested by a large meta-analysis of clinical data in more than 35,000 MS patients (Lublin et al., 2022).

The presence of a “smoldering disease” in the background of MS that leads to PIRA was suggested by a large meta-analysis of clinical data in more than 35,000 MS patients (Lublin et al., 2022).

PIRA was traditionally believed to be the dominant driver of disease worsening in PMS and this was confirmed by this study as well.

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Risk of MS increased 32-fold after infection with EBV but was not increased after infection with other viruses, including the similarly transmitted cytomegalovirus.

Serum levels of NfL, a biomarker of axonal damage, increased only after EBV seroconversion.

Serum levels of neurofilament light chain (“NfL”), a biomarker of axonal damage, increased only after EBV seroconversion.

These findings cannot be explained by any known risk factor for MS and suggest EBV as the leading cause of MS.

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The latter are referred to as disease-modifying therapies.

We intend to develop vidofludimus calcium as a disease-modifying therapy for RMS.

We intend to develop vidofludimus calcium as a disease-modifying therapy for MS.

Historically, the initial treatment options for RMS patients are often beta interferons (either as interferon beta-1a or interferon beta-1b) or glatiramer acetate, all of which are given by injection.

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Other available medications in MS have previously been tested in different forms of PMS, such as siponimod in the Phase 3 EXPAND trial in SPMS patients.

Although the study found a statistically significant effect in active SPMS patients, the treatment for non-active SPMS patients remained elusive.

Although the study found a statistically significant effect in active SPMS patients, the treatment for non-active SPMS patients

remained elusive.

It also highlighted the fact that currently available anti-inflammatory treatments in RMS may in general have no utility in non-active SPMS as the disease progress may be predominantly driven by “smoldering disease” rather than focal inflammation.

Therefore, the unmet medical need in PMS remains high, in particular for the non-active SPMS patient population, where the highest medical need for new therapies exists.

Bruton's tyrosine kinase inhibitors (“BTKi”) have been developed and assessed for both relapsing forms of MS and progressive forms such as PPMS and SPMS.

Evobrutinib’s development was ultimately stopped after Phase 3 trials failed to meet their primary endpoints, leading to discontinuation for lack of efficacy.

Tolebrutinib’s development faced regulatory challenges due to reports of liver toxicity, resulting in a partial clinical hold by the U.S.

Food and Drug Administration (“FDA”).

Most recently, Phase 3 trials for this product failed to meet their primary endpoint in the RMS indication, and in December 2025, the FDA issued a complete response letter clarifying they could not establish a favorable benefit-risk profile for tolebrutinib for indication non-relapsing SPMS.

Fenebrutinib remains in Phase 3 studies, with one of two studies in RMS reported to have met the primary endpoint, and an additional Phase 3 study in PPMS reported to have met the primary endpoint as well.

Remibrutinib also continues its clinical development.

It is generally accepted that current disease-modifying therapies (“DMTs”) are effective in controlling acute focal neuroinflammation resulting in symptoms related to a relapse, however, so far, available DMTs seem to lack significant efficacy effects against progression of the disease independent of MS activity and relapses resulting from smoldering processes such as compartmentalized neuroinflammation and neurodegeneration.

These, together with improved safety and tolerability profiles, are considered key unmet needs for the treatment of MS.

There is no specific guidance on which therapies or medications are used in which sequence of the MS disease course.

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In clinical trials, to date, it has shown data indicating:

• A targeted effect on hyperactive immune cells without suppression of normal immune function.

• Improved rates of confirmed disability worsening.

• Lower rates of confirmed disability worsening and increased rates of confirmed disability improvement.

• Robust MRI lesion suppression, comparing favorably to other medications commercially available for RMS.

• A robust decrease in serum NfL, a biomarker for axonal damage, observed in patients with both RMS and PMS, providing evidence of vidofludimus calcium’s potential direct neuroprotective activity.

• A potent Nurr1 activation, which is involved in protection of relevant neurons from cell death.

• A very low discontinuation rate for MS patients, substantially below placebo, which indicates an encouraging combination of tolerability and efficacy as well as maintenance of normal quality-of-life.

• Absence of hepatotoxicity signals and other relevant adverse events leading to discontinuations, which distinguishes vidofludimus calcium from other oral RMS treatments.

• A robust decrease in serum NfL, a biomarker for axonal damage, observed in patients with both RMS and PMS.

• Potent Nurr1 activation, which is involved in protection of relevant neurons from cell death.

• A targeted effect on hyperactive immune cells without suppression of normal immune function.

• Favorable safety and tolerability profile, with low rates of treatment-emergent adverse events, serious adverse events and adverse events leading to treatment discontinuations, distinguishing vidofludimus calcium from other oral RMS treatments.

• A very low discontinuation rate for MS patients, which indicates an encouraging combination of tolerability and efficacy as well as maintenance of normal quality-of-life.

• A broad spectrum antiviral effect, which may support lowering the rate of viral infections and reactivations, including EBV reactivation, potentially resulting in slowing potential EBV-related neurodegenerative processes.

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Taken together, these last two observations suggest that higher doses, such as 45 mg vidofludimus calcium, may be preferred doses for clinical trials in which neuroprotective effects are the main mechanism for improvement, such as in PMS.

While Cohort 1 blinded treatment was completed right before the coronavirus disease 2019 (“COVID-19”) pandemic, final Cohort 2 data provided additional evidence that ongoing vidofludimus calcium treatment may reduce the risk of COVID-19 infections, presumably related to its known antiviral activity.

In the entire Cohort 2 population of 59 patients, who were enrolled during pandemic conditions, incidental COVID-19 infections in the active treatment group were less frequent (8.5%, n=4/47) than in the placebo group (25.0%, n=3/12).

Additionally, we obtained preclinical data underlining that vidofludimus calcium shows potent anti-EBV activity.

We also confirmed that vidofludimus calcium can be detected to a noteworthy degree in the cerebrospinal fluid of animals, after oral dosing.

We believe that this finding suggests that vidofludimus calcium may be able to act directly within the CNS.

On November 17, 2022, we reported additional data from the EMPhASIS trial.

The trial includes an optional long-term open-label extension (“OLE”) phase running up to 9.5 years.

An interim analysis was performed with data extraction in October 2022, when 209 patients remained on treatment in the OLE phase, some of whom have already received more than 180 continuous weeks (approximately four years) of active treatment with vidofludimus calcium.

The Phase 2 EMPhASIS trial in RRMS includes an optional long-term open-label extension (“OLE”) period for up to 9.5 years to evaluate long-term safety and tolerability of vidofludimus calcium.

Of the 268 patients that started the double-blind main treatment period, 254 patients continued in the OLE period.

On November 17, 2022, we reported an interim analysis of the long-term OLE period with data extraction in October 2022, when 209 patients remained on treatment in the OLE phase, some of whom have already received more than 180 continuous weeks (approximately four years) of active treatment with vidofludimus calcium.

Long-term open-label treatment with vidofludimus calcium was associated with a low rate of confirmed disability worsening over time, comparing favorably to historical trial data for currently available MS medications.

During the 24-week double-blind main treatment period, 12-week and 24-week Confirmed Disability Worsening (“12w/24wCDW”) events occurred in 1.6% of subjects in the combined vidofludimus calcium treatment arms as compared to 3.7% in the placebo group.

During the 24-week double-blind main treatment period, 12wCDW and 24wCDW events occurred in 1.6% of subjects in the combined vidofludimus calcium treatment arms as compared to 3.7% in the placebo group.

In the OLE phase, the proportion of patients free from 12wCDW was 97.6% after 48 weeks and 94.5% after 96 weeks of vidofludimus calcium treatment as compared to the start of the OLE phase.

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The OLE phase also showed low relapse activity.

As of January 2025, more than 180 patients still remained in the OLE phase of the EMPhASIS trial, with more than five total treatment years.

On June 24, 2025, we announced additional long-term OLE data from the EMPhASIS trial.

The data at week 144 showed that 92.3% of patients remained free of 12wCDW, and 92.7% free of 24wCDW.

A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144.

Of these, 44.8% were associated with RAW, while only 13.8% were associated with PIRA.

Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforced the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of

treatment-emergent and serious adverse events.

Importantly, no new safety signals have emerged during treatment durations up to 5.5 years.

The most common treatment-emergent adverse events were mild, with low rates of renal and liver-related events.

Serious adverse events were infrequent and none were deemed related to treatment.

At the time of data cutoff on January 14, 2025, 182 patients were evaluated up to week 144, which translates into approximately 952 overall treatment years, with a low annualized discontinuation rate of approximately 6.4%.

As of January 2026, more than 170 patients continue to be treated in the OLE phase of the EMPhASIS trial, with more than five total treatment years.

Further information regarding our EMPhASIS trial in RRMS can be found on ClinicalTrials.gov under the identifier NCT03846219.

Phase 3 Program of Vidofludimus Calcium in RMS (ENSURE-1 and ENSURE-2 Trials)

On July 1, 2021, we announced U.S.

Food and Drug Administration (“FDA”) clearance of our Investigational New Drug (“IND”) application for the Phase 3 ENSURE program of vidofludimus calcium in patients with RMS.

On July 1, 2021, we announced FDA clearance of our Investigational New Drug (“IND”) application for the Phase 3 ENSURE program of vidofludimus calcium in patients with RMS.

The ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 clinical trials designed to evaluate the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients.

Based on vidofludimus calcium’s highly significant activity in preventing lesion formation in our Phase 2 EMPhASIS trial in RRMS, the strong and consistent correlation observed between lesion formation and clinical relapse in third-party clinical trials, and the drug’s robust safety profile, to date, we believe that this Phase 3 program should provide a straightforward path towards potential regulatory approval of vidofludimus calcium in RMS.

Each of the identical twin Phase 3 clinical 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 will be randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both clinical trials is time to first relapse up to 72 weeks.

Key secondary endpoints include volume of new T2-lesions, time to confirmed disability progression, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change.

With regard to the disability progression endpoint, the ENSURE program will apply a pooled analysis of confirmed disability worsening across both clinical trials.

The primary endpoint for both clinical trials is time to first relapse up to 72 weeks.

Secondary endpoints include total number of new and /or enlarging T2 MRI lesions, time to confirmed disability worsening based on EDSS, number of gadolinium enhancing T1 MRI lesions, and other clinical and MRI-based endpoints.

With regard to the endpoints assessing disability, the ENSURE program will apply a synchronized readout and a pooled assessment across both clinical trials.

The ENSURE trials are being run concurrently.

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The first patient in ENSURE-2 was enrolled in January 2022.

Completion of the first of the ENSURE trials is currently anticipated in the second quarter of 2026;

and the second ENSURE trial in the second half of 2026.

On June 5, 2025, we announced completion of enrollment for both ENSURE trials.

Each of the trials enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the MENA region, Latin America, and Central and Eastern Europe.

In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo.

The top-line data for both ENSURE trials is expected by the end of 2026.

On October 22, 2024, we announced a positive outcome of an interim analysis of our Phase 3 ENSURE program.

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Further information regarding our ENSURE program in RMS can be found on ClinicalTrials.gov under the identifiers NCT05134441 (ENSURE-1) and NCT05201638 (ENSURE-2), respectively.

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On July 1, 2021, we announced that the FDA also cleared our separate IND application for the Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS.

The multicenter, randomized, double-blind, placebo-controlled trial was designed to corroborate vidofludimus calcium’s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of PMS patients to determine the suitability of advancing to a confirmatory Phase 3 program.

The first patient was enrolled in September 2021.

Completion of enrollment was announced in August 2023.

Our current expectation is to read-out top-line data of the CALLIPER trial in April 2025.

The Phase 2 CALLIPER trial is focused on progressive forms of MS.

Its key objective is to corroborate vidofludimus calcium’s neuroprotective potential, as exemplified by slowing of brain atrophy and delay in disability worsening, in this patient population where focal inflammatory disease no longer dominates.

The second objective is to determine whether there is sufficient evidence of efficacy and safety to warrant a confirmatory Phase 3 program in one or more of the PMS subtypes.

Additional clinical studies and the potential regulatory path forward specific to the treatment of PMS will be informed by the results of the CALLIPER trial and will be further assessed accordingly.

Moreover, neurodegeneration is a key concern in both PMS and RMS, since axonal and neural damage is responsible for the increasing and often severe disability experienced by patients.

Therefore, we believe that, if the CALLIPER trial is successful in showing a beneficial effect of vidofludimus calcium, this data, along with the ENSURE program and vidofludimus calcium’s strong safety and tolerability profile, may allow for a meaningful clinical differentiation of vidofludimus calcium from other MS medications and potentially attractive commercial positioning.

However, we do not believe that data from the CALLIPER trial are a pre-condition for filing an NDA in RMS.

The multicenter, randomized, double-blind, placebo-controlled Phase 2 CALLIPER trial of vidofludimus calcium enrolled 467 patients with primary PMS, or active or non-active secondary PMS at more than 70 sites in North America, Western, Central and Eastern Europe.

Completion of enrollment was announced in August 2023, with 467 patients with primary PMS, or active or non-active secondary PMS enrolled at more than 70 sites in North America, Western, Central and Eastern Europe.

Patients were randomized to either 45 mg daily doses of vidofludimus calcium or placebo in a double-blinded fashion.

The trial’s primary endpoint is the annualized rate of percent brain volume change (“PBVC”) up to 120 weeks.

The key secondary endpoint is time to 24-week confirmed composite disability progression based on EDSS, timed 25-foot walk and 9-hole peg test, which may further support disability data from the ENSURE trials.

On October 9, 2023, we announced positive interim data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS.

The predefined interim analysis examined the change from baseline to 24 weeks in serum NfL and glial fibrillar acidic protein ("GFAP") levels among approximately the first half of patients enrolled in this trial.

NfL and GFAP have been shown in third-party research to consistently correlate with disease activity in neurodegenerative disorders and have become two of the most important serum biomarkers for axonal damage over the past few years.

We believe that the interim data showed biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential.

As of January 2025, more than 380 patients are treated in the OLE phase of the CALLIPER trial.

On April 30, 2025, we announced the results from our Phase 2 CALLIPER trial.

In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24wCDW events based on changes in the EDSS compared to placebo.

Consistent reductions in disability worsening were observed in the PPMS and naSPMS subtypes as well as in different subpopulations with or without inflammatory gadolinium-enhanced lesion activity at baseline and during the study.

The total volume of new or enlarging T2 lesions showed a substantial difference between vidofludimus calcium and placebo over time, with vidofludimus calcium decreasing and placebo increasing.

The top-line CALLIPER data set supports the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials.

No new safety signals were identified.

On June 5, 2025, we announced additional data from our Phase 2 CALLIPER trial.

On September 24, 2025, we announced presentations of key vidofludimus calcium data at the 41st Congress of ECTRIMS.

The results from our Phase 2 CALLIPER trial, also selected for the Best of ECTRIMS 2025 slide deck, highlight vidofludimus calcium's neuroprotective potential and its promise to slow disease progression in patients with or without focal inflammation.

Importantly, the consistent 24wCDW results across patient populations and subgroups, including in patients without evidence of baseline inflammatory Gd+ lesions during MRI, were seen both in the overall population and in the PPMS and naSPMS subgroups.

The CALLIPER findings support the hypothesis of neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism.

We have conducted regulatory interactions with health authorities, including the FDA and the European Medicines Agency (“EMA”), following the data from the CALLIPER trial.

These interactions were intended to obtain regulatory feedback on the clinical data package and to discuss potential next steps for the further development of vidofludimus calcium in PMS.

The feedback received from the FDA included considerations related to the overall benefit-risk profile of vidofludimus calcium in the PMS population, the need for additional clinical data to support potential registration, and the context of available approved therapies.

We believe that this feedback provides a clear path forward for starting a confirmatory program for vidofludimus calcium in PMS populations.

As of January 2026, more than 350 patients continue to be treated in the OLE phase of the CALLIPER trial.

Further information regarding our CALLIPER trial in PMS can be found on ClinicalTrials.gov under the identifier NCT05054140.

Ulcerative Colitis

Phase 2 Clinical Trial of Vidofludimus Calcium in UC (CALDOSE-1 Trial)

The CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC was a Phase 2b, dose-finding, multicenter, double-blind, placebo-controlled study including a blinded induction and maintenance phase, with double randomization (initial randomization for induction and second randomization for maintenance).

CALDOSE-1 was conducted at more than 100 sites in 19 countries, including the United States and Western, Central and Eastern Europe.

The primary endpoint comprised a composite of patient-reported outcome and endoscopy-assessed outcome, both evaluated following ten weeks of induction treatment with vidofludimus calcium or placebo.

We have an active IND application for vidofludimus calcium in UC with the FDA.

On June 2, 2022, we reported top-line data from our Phase 2 CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe UC.

The trial did not achieve the primary endpoint of clinical remission for the pooled 30 and 45 mg/day active dose groups of vidofludimus calcium versus placebo at week 10.

In addition, no meaningful differences were observed between the three active dose groups for the overall intent-to-treat patient population or for the trial’s other secondary endpoints, including symptomatic remission, or endoscopic healing.

Consistent with prior data sets in other patient populations, administration of vidofludimus calcium in this clinical trial was observed to be safe and well-tolerated.

On April 5, 2023, we reported positive data from the maintenance phase of our Phase 2b CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe UC.

The data showed a dose-linear increase in clinical remission as compared to placebo at week 50.

Moreover, an exploratory statistical analysis confirmed the 30 mg dose of vidofludimus calcium to be statistically superior (p=0.0358) in achieving clinical remission at week 50, with a 33.7% absolute improvement over placebo.

A similar effect on clinical remission rates at week 50 was also found among those patients who received corticosteroids during the induction phase.

Finally, a dose-linear increase in endoscopic healing was observed, with the 30 mg dose of vidofludimus calcium being associated with a 37.8% absolute improvement over placebo and also achieving statistical significance in an exploratory statistical analysis (p=0.0259).

We believe that the maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's activity in the absence of chronic corticosteroid co-administration.

Consistent with prior data sets in other patient populations, administration of vidofludimus calcium in the maintenance phase of this trial was observed to be safe and well-tolerated.

The results of the CALDOSE-1 trial were published in the peer reviewed journal, Clinical and Translational Gastroenterology (D’Haens et al., 2025).

Further information regarding our CALDOSE-1 trial in UC can be found on ClinicalTrials.gov under the identifier NCT03341962.

Vidofludimus Calcium Registration Plan

All of our drug development candidates require approval from the FDA (for the United States), European Medicines Agency (“EMA”, for the European Union) and other national competent authorities (for any other territory) before they can be marketed for sale in the applicable jurisdiction.

All of our drug development candidates require approval from the FDA (for the United States), EMA (for the European Union) and other national competent authorities (for any other territory) before they can be marketed for sale in the applicable jurisdiction.

The activities required before drugs or biologics may be marketed in the United States include:

• preclinical laboratory tests, in vitro and in vivo preclinical studies and formulation and stability studies;

• In vitro and in vivo preclinical safety and mechanistic studies and formulation and stability studies;

• the submission to the FDA of an investigational new drug application for human clinical testing, which is known as an IND;

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The FDA reviews all available data relating to safety, efficacy and quality and assesses the risk/benefit profile of a product candidate before granting approval.

The data assessed by the FDA in reviewing an NDA includes preclinical testing data, including animal data, chemistry manufacturing and controls (“CMC”) data, PK, pharmacodynamic (“PD”) and drug-drug interaction data, as well as human clinical safety and efficacy data.

The data assessed by the FDA in reviewing an NDA includes preclinical testing data,

including animal data, chemistry, manufacturing and controls (“CMC”) data, PK, pharmacodynamic (“PD”) and drug-drug interaction data, as well as human clinical safety and efficacy data.

Moreover, an agreement for a pediatric development plan (“PSP”) is required to be achieved with the FDA prior to NDA submission.

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In many countries outside of the United States, coverage, pricing and reimbursement approvals are also required.

We have an ongoing Phase 3 clinical program for vidofludimus calcium in RMS and an ongoing Phase 2 clinical trial for vidofludimus calcium in PMS.

For our most advanced indication RMS, marketing approval requires completion of two successful, well-controlled Phase 3 clinical trials.

Completing such clinical trials requires substantial financial and resource investments and takes several years to complete.

In parallel, additional preclinical and clinical investigations need to be conducted in preparation for filing applications for regulatory approval, including additional pharmacological studies in special populations or drug-drug interaction studies.

There are also additional steps required to develop and validate large-scale manufacturing capabilities as well as manufacturing controls.

Certain patient populations with high unmet medical needs in underserved serious diseases, such as non-active SPMS, may also allow to discuss potential expedited approval pathways with regulatory agencies, however, such can only be fully explored following full data readout of the Phase 2 CALLIPER trial.

Vidofludimus Calcium Manufacturing and Formulation

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Dose strengths for clinical trials are 5 mg, 15 mg, 22.5 mg, 30 mg and 45 mg, and a matching placebo.

The tablets are packaged in polyethylene bottles.

The tablets are packaged in high-density polyethylene (“HDPE”) bottles, protected from moisture with desiccant in the cap.

Vidofludimus calcium has been synthesized in several batches of up to 80 kg each of active pharmaceutical ingredient (“API”) and a drug product batch size of up to 500,000 tablets has been produced by manufacturers under contract with us.

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Manufactures under contract with us have developed and produced a formulation of vidofludimus calcium which would allow commercially usable production batches.

A Phase 1 bioequivalence study between the previous and the new formulation of vidofludimus calcium was completed and showed bioequivalence regarding drug exposure curve in blood plasma (area under the curve).

A Phase 1 bioequivalence study between the early development stage formulation and the final formulation of vidofludimus calcium, manufactured with different manufacturing processes, was completed and showed bioequivalence regarding drug exposure curve in blood plasma (area under the curve).

A confirmatory relative bioavailability and food effect study demonstrated a high bioavailability of tablets as compared to a drinking solution and confirmed the in vitro finding of a complete and fast dissolution profile in human subjects.

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Vidofludimus Calcium Intellectual Property, Licenses and Royalties

Vidofludimus calcium is covered 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 salt forms of vidofludimus, including the

specific calcium salt form used in Immunic’s clinical trials;

We follow a multi-layered intellectual property (“IP”) approach for vidofludimus calcium.

Currently, 10 independent patent families are expected to provide exclusivity up to 2044 in the United States, or even beyond.

Currently, 4 to 5 granted patents are ready for prospective listing in the Orange Book, the FDA's publication of Approved Drug Products with Therapeutic Equivalence Evaluations.

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 RRMS with a specific dose strength used in the clinical trials;

the treatment of PMS with specific dose strengths used in the clinical trials;

the dosing regimens, including those used in clinical trials for the treatment of MS, 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, a pending application is directed towards the use of vidofludimus calcium and other salt forms as well as free acid forms for treating neurodegenerative diseases.

If granted, this application could provide protection up to 2044, 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.

An additional patent, covering the treatment of long COVID, has been granted in the US and in Europe, also providing protection until 2041.

Finally, further undisclosed patent applications dedicated to strengthening the exclusivity period are currently in process.

On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection.

Vidofludimus calcium and izumerogant were acquired in a transaction with 4SC in September 2016.

We have subsequently submitted additional patent applications for independently developed intellectual property relating to each of vidofludimus calcium and izumerogant.

Further undisclosed patent applications dedicated to strengthening the exclusivity period are currently in process.

In addition to the patent exclusivity, vidofludimus calcium, as a new chemical entity, also is expected to benefit from regulatory data protection.

Vidofludimus calcium was acquired in a transaction with 4SC in September 2016.

We have subsequently submitted additional patent applications for independently developed intellectual property.

On March 31, 2021, our German subsidiary, Immunic AG, and 4SC entered into a Settlement Agreement, pursuant to which Immunic AG settled its remaining obligation of a 4.4% royalty on net sales for $17.25 million.

The payment was made 50% in cash and 50% in shares of our common stock.

Based on preclinical data, we believe this compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, IBD, GvHD, irritable bowel syndrome with diarrhea and other intestinal barrier function associated diseases.

We believe that, because IMU-856 has been shown in preclinical investigations to avoid suppression of immune cells, it may therefore have the potential to maintain immune surveillance for patients during therapy, which would be an important advantage versus immunosuppressive medications.

IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium.

Impaired intestinal barrier function is suspected to be involved in the initiation of many chronic inflammatory or autoimmune conditions, and microbial translocation through the damaged gut mucosa has been associated with many diseases, not only of the bowel but of the whole body.

To date, there are no adequate treatment strategies to ameliorate impaired barrier function.

IMU-856 has also shown potential as an oral treatment option for weight management, by increasing endogenous GLP-1 levels in patients and reducing body weight gain and food consumption in preclinical in vivo testing.

Celiac Disease

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The third portion of the Phase 1 clinical trial of IMU-856 was structured as a double-blind, randomized, placebo-controlled Phase 1b trial, designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and a 15-day gluten challenge with 6 g gluten given daily.

The trial was conducted at sites in Australia and New

The trial was conducted at sites in Australia and New Zealand.

A total of 43 patients were enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 or placebo given once-daily over 28 days.

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Most importantly, the observed protection of intestinal villi from gluten-induced destruction, independent of targeting immune mechanisms involved specifically in celiac disease, appears to be unique among proposed therapeutic approaches and may be applicable to other gastrointestinal diseases such as IBD, short bowel syndrome and irritable bowel syndrome with diarrhea.

Contingent on financing, licensing or partnering, we are currently preparing clinical Phase 2 testing of IMU-856 in patients with OACD despite gluten-free diet, while also considering further potential clinical applications in other gastrointestinal disorders.

Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing

On February 20, 2025, we announced that IMU-856 demonstrated a dose-dependent increase of endogenous GLP-1 levels in a post hoc analysis of patients from our Phase 1b clinical trial in celiac disease.

IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing.

The post hoc analysis of our Phase 1b clinical trial of IMU-856 in celiac disease patients measured blood concentrations of GLP-1, between baseline and day 28, in a fasting state.

A highly statistically significant (day 29:

80 mg p=0.014;

160 mg p=0.003) and dose-dependent increase of GLP-1 versus placebo control was detectable, even in the small patient population in this Phase 1b clinical trial (baseline:

N placebo = 11, N 80 mg IMU-856 = 13, N 160 mg IMU-856 = 13).

Effects on enteric hormones such as GLP-1 have been shown to provide additional favorable outcomes in multiple gastrointestinal diseases.

The observed GLP-1 effects of IMU-856 may therefore provide an additional mechanism to strengthen its clinical value.

We believe that this should be further evaluated in future clinical development.

Contingent on financing, licensing or partnering, we are currently preparing further clinical testing of IMU-856.

IMU-856 Manufacturing and Formulation

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For the Phase 1/1b clinical trial, IMU-856 was synthesized at up to 8 kg scale.

Developed dose strengths were 40 mg, 80 mg and 160 mg, and a matching placebo.

The tablets were packaged in polyethylene bottles.

Developed dose strengths were 10 mg, 40 mg, 80 mg and 160 mg, and a matching placebo.

The tablets were packaged in HDPE bottles.

The tablets were produced by a manufacturer under contract with us and finally released for the clinical trial by a vendor in Australia.

For Phase 2 clinical testing, we have developed a new, improved formulation of IMU-856 which is more stable and robust.

For Phase 2 clinical testing, we have developed a new, improved formulation of IMU-856 for 60 mg, 150 mg and 240 mg dose strengths, which is stable and its manufacturing process robust.

IMU-856 Intellectual Property, Licenses and Royalties

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A patent application covering composition-of-matter of IMU-856 and related pharmaceutical compositions has been granted in the US and other jurisdictions and is expected to provide protection into at least 2038, without accounting for potential patent term extension.

In addition, a pending application is directed towards the treatment of inflammatory/gastrointestinal diseases (e.g., celiac disease) with IMU-856.

Further undisclosed patent applications dedicated to other diseases are currently in processing.

We have selected IMU-381 as a development candidate to specifically address the needs of gastrointestinal diseases.

IMU-381 is a next generation molecule with improved overall properties, supported by a series of chemical derivatives.

IMU-381 is currently in preclinical testing.

In addition, pending applications for IMU-856 are directed towards the treatment of inflammatory/gastrointestinal diseases (e.g., celiac disease), reducing body weight and/or induction of satiety, and treatment of GvHD.

A further undisclosed patent application dedicated to other diseases has been filed.

We have selected the IMU-381 program to leverage our Nurr1 platform for neurologic, gastrointestinal and other autoimmune diseases.

The platform comprises next-generation molecules, including a series of chemical derivatives, with improved overall properties.

The IMU-381 program is currently in preclinical testing.

Gliomic Therapeutics:

Synthetic Lethality for Genetically-Defined Brain Tumors

Through our wholly-owned subsidiary Gliomic Therapeutics Inc., we are pursuing the use of new compounds in brain cancers leveraging our expertise in DHODH inhibition.

A group of prominent scientists from Harvard Medical School and the University of Texas Southwestern discovered that certain genetically defined groups of brain cancer appear to be exceptionally sensitive to DHODH inhibition.

We worked with this group to develop a series of drug candidates specifically for neuro-oncology with unusually high potency, brain penetrance, and target selectivity.

These candidates have been subsequently tested in vitro and in vivo , showing not only highly selective

killing of tumor cells, but also increased survival in animals implanted intracranially with patient-derived tumor cells, as well as early evidence of very favorable tolerability in mice.

In order to retain Immunic’s focus on our Phase 3 program in MS, as well as our broader clinical focus on immunologic diseases, Gliomic was spun out to pursue the use of these new compounds in brain cancers.

Importantly, for critical scientific reasons, these new compounds would not be appropriate in MS, do not target Nurr1 activation and therefore are not competitive with vidofludimus calcium.

At the moment, Gliomic is a very lean organization, owned entirely by Immunic, with a single employee under the direction of Immunic itself, who is focused on obtaining external funding for Gliomic.

As a wholly owned entity, Gliomic coordinates all of its activities with Immunic, and Immunic retains the final authority and priority in all matters.

Any moneys being spent by Gliomic now are modest, and entirely at the discretion of Immunic itself.

We plan to provide additional updates in the foreseeable future.

Government Regulation - All Products

In the United States, the FDA regulates drugs under the federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations.

All of Immunic’s drug development candidates require approval from the FDA (for the United States), EMA (for the European Union) and/or other national competent authorities (for any other territory) before they can be

marketed for sale in the applicable jurisdiction.

The activities required before drugs or biologics may be marketed in the United States include:

• preclinical laboratory tests, in vitro and in vivo preclinical studies and formulation and stability studies;

• In vitro and in vivo preclinical safety and mechanistic studies and formulation and stability studies;

• the submission to the FDA of an application for human clinical testing, which is known as an IND application;

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Even if the sponsor submits the recommended data and information, the FDA may decide that the resubmitted NDA does not satisfy the criteria for approval.

As condition to a product’s regulatory approval, the FDA may require a sponsor to conduct Phase 4 studies designed to further assess the drug’s safety and effectiveness after NDA approval, or may require other testing and surveillance programs to monitor the safety of the approved product.

As a condition to a product’s regulatory approval, the FDA may require a sponsor to conduct Phase 4 studies designed to further assess the drug’s safety and effectiveness after NDA approval, or may require other testing and surveillance programs to monitor the safety of the approved product.

The FDA may also place other conditions on approval including the requirement for a risk evaluation and mitigation strategy (“REMS”) to assure the safe use of the drug.

A REMS could include medication guides, communication plans to healthcare professionals or other activities to assure safe use, such as provider certification or training, restricted distribution methods, and patient registries.

A REMS could include medication

guides, communication plans to healthcare professionals or other activities to assure safe use, such as provider certification or training, restricted distribution methods, and patient registries.

Research and Development

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Human Capital

As of March 1, 2025, we had 91 employees, eight of whom held M.D.

As of February 1, 2026, we had 92 employees, nine of whom held M.D.

degrees and 30 of whom held Ph.D.

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We emphasize several measures and objectives in managing our human capital assets, including, among others, (i) employee safety and wellness, (ii) talent acquisition and retention, (iii) employee engagement, development and training, (iv) diversity and inclusion and (v) compensation.

These targeted ideals may include annual bonuses, stock-based compensation awards, a 401(k) plan, healthcare, and insurance benefits, paid time-off, family leave, employee assistance programs.

These targeted ideals may include annual bonuses, stock-based compensation awards, a 401(k) plan, healthcare and insurance benefits, paid time-off, family leave, child-care, and employee assistance programs.

We also provide our employees with access to various innovative, flexible, and convenient health and wellness programs.

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Following the exchange, we changed our name to Immunic, Inc.

and we became a clinical-stage biopharmaceutical company focused on the development of selective oral therapies in immunology with the goal of becoming a leader in treatments for chronic inflammatory and autoimmune diseases.

and we became a clinical-stage biopharmaceutical company focused on the development of selective oral therapies in immunology.

Our corporate headquarters are located at 1200 Avenue of the Americas, Suite 200, New York, New York 10036.

We also have an office at Lochhamer Schlag 21, 82166 Gräfelfing, Germany and a research laboratory in Planegg, Germany.

We also have an office at Lochhamer Schlag 21, 82166 Gräfelfing, Germany and a research laboratory at Fraunhoferstraße 1, 82152 Planegg, Germany.

Our telephone number is (332) 255-9818.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business