IMMUNIC, INC.

Previous wording

described in our most recent Annual Report on Form 10-K filed with the SEC (the "2025 Annual Report"), and the differences may be material. These risk factors include, but are not limited to statements relating to our development programs and the targeted diseases; the potential for vidofludimus calcium and IMU-856 to safely and effectively target diseases; the nature, strategy and focus of the Company; expectations regarding our capitalization and financial resources; the development, timing and commercial potential of any product candidates of the Company; and our ability to attract and retain certain personnel important to our ongoing operations and to maintain effective internal control over financial reporting.

Current wording

The inclusion of any forward-looking statements in this Quarterly Report should not be regarded as a representation that any of our plans will be achieved. Our actual results may differ from those anticipated in our forward-looking statements as a result of various factors, including those noted below under the caption “Part II, Item 1A-Risk Factors,” and the risk factors described in our most recent Annual Report on Form 10-K filed with the SEC (the "2025 Annual Report"), and the differences may be material. These risk factors include, but are not limited to statements relating to our development programs and the targeted diseases; the potential for vidofludimus calcium, IMU-381 and IMU-856 to safely and effectively target diseases; the nature, strategy and focus of the Company; expectations regarding our capitalization and financial resources; the development, timing and commercial potential of any product candidates of the Company, including the timing of any new drug application submission and regulatory approval; our anticipated commercialization strategy and expectations regarding the size of the market opportunities for our product candidates; the impact of government laws, regulations and tariffs; and our ability to attract and retain certain personnel important to our ongoing operations and to maintain effective internal control over financial reporting.

Previous wording

Immunic, Inc. (“Immunic," “we,” “us,” “our” or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. We are headquartered in New York City with our research and development operations in Gräfelfing near Munich, Germany. We had approximately 95 employees as of April 30, 2026.

Current wording

Immunic, Inc. (“Immunic," “we,” “us,” “our” or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. We are headquartered in New York City with our research and development operations in Gräfelfing near Munich, Germany. We had approximately 100 employees as of July 31, 2026. We believe our lead candidate, vidofludimus calcium, positions us to pivot toward becoming a fully integrated commercial-stage multiple sclerosis (“MS”) company, and we are building the commercial, regulatory and organizational capabilities to support a potential launch in relapsing MS, while continuing to advance our pipeline in progressive MS and other neurologic indications.

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

The Phase 3 ENSURE program of vidofludimus calcium in relapsing MS, comprising twin studies evaluating efficacy, safety, and tolerability of vidofludimus calcium versus placebo, is currently ongoing. In October 2024, we announced a positive outcome of an interim analysis of the ENSURE program, with an unblinded Independent Data Monitoring Committee ("IDMC") confirming that the predetermined futility criteria have not been met and recommending that both ENSURE trials should continue without changes, including no need for a potential increase of the sample size. In June 2025, we announced completion of enrollment for both ENSURE trials. Each of the trials enrolled adult patients with active relapsing MS at more than 100 sites in 15 countries. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either a 30 mg daily dose of vidofludimus calcium or placebo. The top-line data for both ENSURE trials is expected by the end of 2026. Although we currently believe that this goal is achievable, it is dependent on numerous factors, most of which are not under our direct control and can be difficult to predict. We plan to periodically review this assessment and provide updates of material changes as appropriate. If the ENSURE trials are positive, we intend to target submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration in mid-2027, with potential U.S. regulatory approval in 2028.

Previous wording

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 worsening (“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.

Current wording

Our Phase 2 CALLIPER trial of vidofludimus calcium in progressive MS was designed to corroborate vidofludimus calcium’s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of progressive MS patients to determine the suitability of advancing to a confirmatory Phase 3 program. In 2025, we announced the results from the CALLIPER trial. Even though the primary percent brain volume change (“PBVC”) endpoint was not met, exploratory imaging and clinical outcomes revealed consistent, directionally favorable signals. The data showed substantial and medically relevant numerical reductions in 24-week confirmed disability worsening (“24wCDW”) across patient populations and subgroups without evidence of focal inflammation; consistent increases in 24-week confirmed disability improvement (“24wCDI”); as well as reductions in the annualized rate of thalamic brain volume loss, volume of new or enlarging T2 lesions and slowly expanding lesions (“SEL”) count over time. The CALLIPER data also confirmed the favorable safety and tolerability profile of vidofludimus calcium, similar to placebo, as already observed in previous clinical trials. Initiation of a Phase 3 clinical trial of vidofludimus calcium in progressive MS is expected later in 2026.

Previous wording

If approved, we believe that vidofludimus calcium, with combined neuroprotective, anti-inflammatory, and antiviral effects as well as a favorable safety and tolerability profile, has the potential to be a unique treatment option targeted to the complex pathophysiology of MS. Preclinical data showed that vidofludimus calcium activates the neuroprotective transcription factor Nurr1, which is associated with direct neuroprotective effects and may enhance the potential benefit for patients. Additionally, vidofludimus calcium is a selective inhibitor of the enzyme dihydroorotate dehydrogenase (“DHODH”), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and antiviral effects of vidofludimus calcium. We believe that the combined mechanisms of vidofludimus calcium are unique in the MS space and support the therapeutic performance observed in our Phase 2 EMPhASIS trial in 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.

Current wording

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 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 anti-inflammatory and antiviral effects of vidofludimus calcium. We believe that the combined mechanisms of vidofludimus calcium are unique in the MS space and support the therapeutic performance observed in our Phase 2 EMPhASIS trial in relapsing-remitting MS patients and in our Phase 2 CALLIPER trial in progressive MS patients. Vidofludimus calcium has shown a consistent pharmacokinetic, safety and tolerability profile, to date. Over 3,500 participants have been exposed to vidofludimus in completed and ongoing clinical trials, with a maximum continuous exposure of more than 6.5 years.

Previous wording

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.

Current wording

We have selected the IMU-381 program to leverage our Nurr1 platform for neurologic and 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.

Previous wording

IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (“SIRT6”), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, we believe this compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, IBD, GvHD and other intestinal barrier function associated diseases. Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance for patients during therapy, which would be an important advantage versus immunosuppressive medications and may allow the potential for combination with available treatments in multiple gastroenterological diseases.

Current wording

IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (“SIRT6”), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, we believe this compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, IBD, GvHD and other intestinal barrier function associated diseases. We are currently exploring strategic alternatives for the IMU-856 program and are open to discussing potential financing, licensing or partnering options with interested parties.

Previous wording

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 generating intellectual property in these areas. We are also exploring several options to possibly support further development of certain assets and technologies, including a potential spin-off into a new company and potential licensing transactions. Through our wholly-owned subsidiary Gliomic Therapeutics Inc., we are pursuing the use of new compounds in brain cancers leveraging our expertise in DHODH inhibition.

Current wording

Additional research and development activities remain ongoing through preclinical research examining the potential to treat a broad set of neurologic and autoimmune diseases with new molecules leveraging our chemical and pharmacological research platform as well as generating intellectual property in these areas. We are also exploring several options to possibly support further development of certain assets and technologies, including a potential spin-off into a new company and potential licensing transactions. Through our wholly-owned subsidiary Gliomic Therapeutics Inc., we are pursuing the use of new compounds in brain cancers leveraging our expertise in DHODH inhibition.

Previous wording

We expect to continue to lead most of our research and development activities from our Gräfelfing, Germany location, where dedicated scientific, regulatory, clinical and medical teams conduct their activities. Due to these teams' key relationships with local and international service providers and academic partners, we anticipate that this should result in more timely and cost-effective execution of our development programs. In addition, we are using our subsidiary in Melbourne, Australia to perform research and development activities in the Australasia region. We also conduct preclinical work in our laboratory in Martinsried, Germany and in Halle/Saale, Germany and through a collaboration with the Fraunhofer Institute.

Current wording

We expect to continue to lead most of our research and development activities from our Gräfelfing, Germany location, where dedicated scientific, regulatory, clinical and medical teams conduct their activities. Due to these teams' key relationships with local and international service providers and academic partners, we anticipate that this should result in more timely and cost-effective execution of our development programs. In addition, we are using our subsidiary in Melbourne, Australia to perform research and development activities in the Australasia region. We also conduct preclinical work in our laboratory in Martinsried, Germany, and through a collaboration with the Fraunhofer Institute in Halle/Saale, Germany.

Previous wording

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.

Current wording

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 development programs.

Previous wording

We are focused on the development of new molecules that maximize the therapeutic benefits for patients by uniquely addressing biologically relevant immunological targets. We take advantage of our established research and development infrastructure and operations in Germany and Australia to more efficiently develop our product candidates in indications of high unmet need and where the product candidates have the potential to elevate the standard of care for the benefit of patients. Given the mechanisms of action and the data generated for our product candidates, to date, we continue to execute on the clinical development of our programs for established indications as well as explore additional indications where patients could potentially benefit from the unique profiles of each product candidate.

Current wording

We are focused on the development and potential commercialization of new molecules that maximize the therapeutic benefits for patients by uniquely addressing biologically relevant immunological targets. We take advantage of our established research and development infrastructure and operations in Germany to more efficiently develop our product candidates in indications of high unmet need and where the product candidates have the potential to elevate the standard of care for the benefit of patients. Given the mechanisms of action and the data generated for our product candidates, to date, we continue to execute on the clinical development of our programs for established indications as well as explore additional indications where patients could potentially benefit from the unique profiles of each product candidate.

Previous wording

•Preparation of a Phase 3 clinical program of vidofludimus calcium in primary progressive MS, following the successful completion of the Phase 2 CALLIPER clinical trial in PMS and feedback from healthcare authorities.

Current wording

•Initiating a Phase 3 clinical program of vidofludimus calcium in progressive MS, following the successful completion of the Phase 2 CALLIPER trial and feedback from healthcare authorities.

Previous wording

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

Current wording

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

Previous wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $641.2 million as of March 31, 2026 and $608.6 million as of December 31, 2025. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $675.3 million as of June 30, 2026 and $608.6 million as of December 31, 2025. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Previous wording

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.

Current wording

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we initiate and continue the development of our product candidates and add personnel necessary to advance our pipeline of product candidates. We expect that our operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of development programs.

Previous wording

From inception through March 31, 2026, the Company raised net cash of approximately $684.9 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights. As of March 31, 2026, we had cash and cash equivalents of approximately $186.6 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.

Current wording

From inception through June 30, 2026, we have raised net cash of approximately $684.9 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights. As of June 30, 2026, we had cash and cash equivalents of approximately $155.1 million. With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.

Previous wording

On April 14, 2026, we held a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, our stockholders voted to authorize our Board of Directors, in its discretion, to amend our certificate of incorporation, as amended and restated, to effect a reverse stock split of all of the outstanding shares of the Common Stock, at a ratio in the range of 1-for-10 to 1-for-30, with such ratio to be determined by the Board. Following the Special Meeting, the Board approved a reverse stock split of our issued and outstanding Common Stock, at a ratio of 1-for-10 shares, which became effective April 27, 2026 (the “Reverse Stock Split”). All share amounts in this document have been adjusted retroactively to reflect the reverse stock split.

Current wording

On April 14, 2026, we held a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, our stockholders voted to authorize our Board of Directors ("the "Board"), in its discretion, to amend our certificate of incorporation, as amended and restated, to effect a reverse stock split of all of the outstanding shares of the Common Stock, at a ratio in the range of 1-for-10 to 1-for-30, with such ratio to be determined by the Board. Following the Special Meeting, the Board approved a reverse stock split of our issued and outstanding Common Stock, at a ratio of 1-for-10 shares, which became effective April 27, 2026 (the “Reverse Stock Split”). All share amounts in this document have been adjusted retroactively to reflect the reverse stock split.

Previous wording

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.

Current wording

On February 12, 2026, our 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.

Previous wording

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.

Current wording

On February 4, 2026, we announced the presentation of additional data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive MS at the Americas Committee for Treatment and Research in Multiple Sclerosis (“ACTRIMS”) Forum 2026. The findings presented in two poster presentations provide additional evidence of vidofludimus calcium’s effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (“EBV”) and magnetic resonance imaging (“MRI”) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.

Previous wording

On March 31,2026, we announced the appointment of Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to our Board of Directors, effective March 27, 2026. In connection with his appointment as a director, Mr. Congleton received an inaugural grant of options to purchase up to a total of 50,000 shares of the Company’s common stock, effective March 27, 2026, which vest on a monthly basis over a three-year period.

Current wording

On March 31, 2026, we announced the appointment of Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to our Board, effective March 27, 2026. In connection with his appointment as a director, Mr. Congleton received an inaugural grant of options to purchase up to a total of 50,000 shares of the Company’s common stock, effective March 27, 2026, which vest on a monthly basis over a three-year period.

Previous wording

Pursuant to the Agreement, subject to Dr. Vitt's continued employment with the Company through the ninety-first (91st) day after a new Chief Executive Officer is hired by the Company, Dr. Vitt shall be entitled to receive a retention bonus equal to $670,000, less applicable withholdings and payroll deductions. The Retention Bonus will be paid in one lump sum on the first regularly scheduled pay date after the Retention Date, subject to the terms and conditions of the Agreement.

Current wording

Pursuant to the Agreement, subject to Dr. Vitt's continued employment with the Company through August 31, 2026, Dr. Vitt shall be entitled to receive a retention bonus equal to $670,000, less applicable withholdings and payroll deductions. The Retention Bonus will be paid in one lump sum on the first regularly scheduled pay date after the Retention Date, subject to the terms and conditions of the Agreement.

Previous wording

Effective April 24, 2026, Michael A. Panzara, M.D., M.P.H., was appointed as our Chief Medical Officer. Dr. Panzara will lead our development organization, including clinical development, medical affairs, and regulatory affairs, and will be a critical partner to the Chief Executive Officer and the Board of Directors in defining and driving the overall company strategy. Dr. Panzara brings over 25 years of global neurology experience to Immunic. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A.

Current wording

Effective April 24, 2026, Michael A. Panzara, M.D., M.P.H., was appointed as our Chief Medical Officer. Dr. Panzara will lead our development organization, including clinical development, medical affairs, and regulatory affairs, and will be a critical partner to the Chief Executive Officer and the Board in defining and driving the overall company strategy. Dr. Panzara brings over 25 years of global neurology experience to Immunic. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A.

Previous wording

Since our inception in March 2016, we have spent a total of approximately $485.6 million in research and development expenses through March 31, 2026.

Current wording

Since our inception in March 2016, we have spent a total of approximately $511.5 million in research and development expenses through June 30, 2026.

Previous wording

These costs primarily include external development expenses and internal personnel expenses for the three development programs, vidofludimus calcium, IMU-856 and IMU-381. We have spent the majority of our research and development resources on vidofludimus calcium, our lead development program, for clinical trials in MS and UC.

Current wording

These costs primarily include external development expenses and internal personnel expenses for the three development programs, vidofludimus calcium, IMU-381 and IMU-856. We have spent the majority of our research and development resources on vidofludimus calcium, our lead development program, for clinical trials in MS and UC.

Previous wording

Research and development expenses increased by $4.1 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The increase reflects (i) a $2.9 million increase in external development costs related to the vidofludimus calcium program, (ii) a $1.0 million increase in personnel expenses, $0.7 million of which was related to non-cash stock compensation and (iii) a $0.2 million increase related costs across numerous categories.

Current wording

Research and development expenses increased by $4.6 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase reflects (i) a $4.4 million increase in personnel expenses, $3.2 million of which was related to non-cash stock compensation, (ii) a $1.6 million increase due to drug-drug interaction studies in support of a potential NDA filing, (iii) a $1.1 million increase related to costs across numerous categories, partially offset by (iv) a $2.0 million decrease related to our CALLIPER clinical trial and (v) a $0.5 million decrease related to our ENSURE clinical trials.

Previous wording

General and administrative expenses increased by $2.3 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The increase was due to (i) a $2.0 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation, (ii) a $0.2 million increase in legal and consultancy expenses, (iii) a $0.2 million increase in marketing expenses, which was partially offset by a $0.1 million decrease related to costs across numerous categories.

Current wording

General and administrative expenses increased by $3.7 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was due to (i) a $2.1 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation (ii) a $0.7 million increase in legal and consultancy expenses, (iii) a $0.4 million increase in pre-commercial marketing expenses, and (iv) a $0.5 million increase in related costs across numerous categories.

Previous wording

Interest income increased $0.6 million during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025. This is due to a higher average cash balance as a result of the February 2026 Private Placement.

Current wording

Interest income increased $1.0 million during the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. This was due to a higher average cash balance as a result of the February 2026 Private Placement.

Previous wording

Other income (expense) decreased by $1.3 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. The decrease was primarily attributable to (i) a $1.1 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and no grant income in 2026 and (ii) a $0.2 million decrease across numerous categories.

Current wording

Other income (expense) decreased by $1.4 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease was primarily attributable to (i) a $1.0 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and no grant income in 2026 and (ii) a $0.4 million decrease across various categories.

Previous wording

Immunic has no products approved for commercial sale and has not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. The Company has an accumulated deficit of approximately $641.2 million as of March 31, 2026 and $608.6 million as of December 31, 2025. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $675.3 million as of June 30, 2026 and $608.6 million as of December 31, 2025. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Previous wording

From inception through March 31, 2026, we have raised net cash of approximately $684.9 million from private and public offerings of preferred stock, common stock, prefunded warrants and tranche rights. As of March 31, 2026, we had cash and cash equivalents of approximately $186.6 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.

Current wording

From inception through June 30, 2026, we have raised net cash of approximately $684.9 million from private and public offerings of preferred stock, common stock, prefunded warrants and tranche rights. As of June 30, 2026, we had cash and cash equivalents of approximately $155.1 million. With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.

Previous wording

In November 2023, we filed a shelf registration statement on Form S-3 (the "2023 Shelf Registration Statement"). The 2023 Shelf Registration Statement permits the offering, issuance and sale of up to $250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing. The 2023 Registration Statement was declared effective on May 31, 2024. Unsold securities from the expired 2020 Shelf Registration Statement can continue to be sold under the 2023 Shelf Registration Statement. As a result of the April 2025 Offering and May 2025 Offering, the total amount available under the 2023 Shelf Registration Statement was reduced by $70.1 million to $262.2 million as of March 31, 2026. The Company can also use the unused amount (currently $80 million) of the available ATM as additional shelf availability.

Current wording

In November 2023, we filed a shelf registration statement on Form S-3 (the "2023 Shelf Registration Statement"). The 2023 Shelf Registration Statement permits the offering, issuance and sale of up to $250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing. The 2023 Registration Statement was declared effective on May 31, 2024. Unsold securities from the expired 2020 Shelf Registration Statement can continue to be sold under the 2023 Shelf Registration Statement. As a result of the April 2025 Offering and May 2025 Offering, the total amount available under the 2023 Shelf Registration Statement was reduced by $70.1 million to $262.2 million as of June 30, 2026. The Company can also use the unused amount (currently $80.0 million) of the available ATM as additional shelf availability.

Previous wording

We did not have any ATM activity during the three months ended March 31, 2026 and 2025.

Current wording

We did not have any ATM activity during the three or six months ended June 30, 2026 or 2025.

Previous wording

The following table shows a summary of our cash flows for the three months ended March 31, 2026 and 2025:

Current wording

The following table shows a summary of our cash flows for the six months ended June 30, 2026 and 2025:

Previous wording

During the three months ended March 31, 2026, operating activities used $17.3 million of cash. The use of cash primarily resulted from our net loss of $32.6 million adjusted for non-cash charges of $4.7 million primarily related to stock-based compensation of $4.5 million and non-cash lease expense of $0.2 million and a $10.6 million net increase in our operating assets and liabilities. Changes in our operating assets and liabilities during the three months ended March 31, 2026 consisted primarily of a net increase of $5.2 million in other current assets and prepaid expenses and $5.6 million in accounts payable and other accrued expenses.

Current wording

During the six months ended June 30, 2026, operating activities used $48.3 million of cash. The use of cash primarily resulted from (i) our net loss of $66.7 million adjusted for non-cash charges of $11.7 million related to $11.2 million for stock-based compensation and $0.4 million related to non-cash lease expense and depreciation (ii) a $6.7 million net increase in our operating assets and liabilities. Changes in our operating assets and liabilities during the six months ended June 30, 2026 consisted primarily of a $4.5 million increase in other current assets and prepaid expenses and a net increase of. $2.2 million in our other current liabilities.

Previous wording

During the three months ended March 31, 2025, operating activities used $21.8 million of cash. The use of cash primarily resulted from (i) our net loss of $25.5 million adjusted for non-cash charges of $2.2 million related to $2.0 million for stock-based compensation, $0.1 million related to non-cash lease expense, and $0.1 million related to depreciation and (ii) a $1.5 million net increase in our operating assets and liabilities. Changes in our operating assets and liabilities during the three months ended March 31, 2025 consisted primarily of a net increase of $2.4 million in accounts payable and other accrued expenses partially offset by $0.8 million decrease in our other current assets and prepaid expenses.

Current wording

During the six months ended June 30, 2025, operating activities used $46.4 million of cash. The use of cash primarily resulted from (i) our net loss of $52.3 million adjusted for non-cash charges of $4.1 million related to $3.9 million for stock-based compensation, $0.1 million related to non-cash lease expense and $0.1 million related to depreciation (ii) a $1.8 million net decrease in our operating assets and liabilities. Changes in our operating assets and liabilities during the six months ended June 30, 2025 consisted primarily of a $2.3 million increase in our other current liabilities partially offset by a decrease in other current assets and prepaid expenses of $0.4 million.

Previous wording

During the three months ended March 31, 2026, net investing activities used $2,000 due to the purchase of property and equipment.

Current wording

During the six months ended June 30, 2025, net investing activities used $0.3 million due to the purchase of property and equipment.

Previous wording

During the three months ended March 31, 2025, net investing activities used $47,000 due to the purchase of property and equipment.

Current wording

During the six months ended June 30, 2025, net investing activities used $0.1 million due to the purchase of property and equipment.

Previous wording

Net cash provided by financing activities was $188.6 million during the three months ended March 31, 2026 primarily consisting of net cash proceeds of $187.3 from the February 2026 Private Placement and $1.4 million from the exercise of a portion of the Series B warrants.

Current wording

Net cash provided by financing activities was $188.8 million during the six months ended June 30, 2026 consisting of net cash proceeds of $187.3 from the February 2026 Private Placement and $1.4 million from the exercise of a portion of the Series B warrants, as well as proceeds from the issuance of shares issued in connection with our employee stock purchase plan and the exercise of employee stock options.