Vidofludimus

– Key Data Highlighting Vidofludimus Calcium's Therapeutic Potential in Multiple Sclerosis Presented at 41st Congress of ECTRIMS – – Phase 2 CALLIPER Data Demonstrated Statistically Significant 24-Week Confirmed Disability Improvement in Progressive Multiple Sclerosis, With Consistent Signals for Slowing Disability Progression Across Subgroups and Endpoints, Supporting Vidofludimus Calcium's Neuroprotective Potential and Nurr1 Activation Mechanism – – Long-Term Phase 2 EMPhASIS Data in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of Confirmed Disability Worsening and Favorable Long-Term Safety and Tolerability – – Top-Line Data from Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 – NEW YORK, Nov. 13, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX) , a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the three and nine months ended September 30, 2025, and provided a corporate update. "The third quarter was marked by our strong presence at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), during which we had the opportunity to highlight the clinical momentum of our lead asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor-related 1 (Nurr1) activator, and its potential to transform the oral multiple sclerosis (MS) therapy landscape," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The collective data meanwhile available from across our clinical MS trials, including the phase 2 CALLIPER and EMPhASIS trials, highlight vidofludimus calcium's unique promise to slow disability progression in both relapsing and progressive forms of the disease. Notably, new data from our positive phase 2 CALLIPER trial in progressive MS (PMS), also featured in the Best of ECTRIMS 2025 slide deck, showed statistically significant 24-week confirmed disability improvement in the overall patient population and consistent effects across both the primary progressive MS (PPMS) and non-active secondary progressive MS (naSPMS) subgroups, further reinforcing the compound's neuroprotective and anti-inflammatory characteristics." "We believe the CALLIPER data clearly support advancing vidofludimus calcium into phase 3 development in progressive forms of MS. With only one approved therapy currently available for PPMS, there is a significant opportunity in this underserved, multi-billion-dollar market. By slowing disease progression, vidofludimus calcium could help patients maintain independence, manage symptoms more effectively, and achieve improved long-term outcomes." Dr. Vitt continued, "Notably, we also presented additional long-term data from the open-label extension (OLE) period of our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) at ECTRIMS, which further highlighted the robust efficacy signals and favorable safety and tolerability observed, to date. Our twin phase 3 ENSURE trials in relapsing MS (RMS) remain on track. Given vidofludimus calcium's unique profile and its potential to become the oral therapy of choice addressing the full spectrum of MS, we look forward to reporting top-line data by the end of 2026." "We also successfully continued our efforts to meaningfully enhance our strong and multi-layered intellectual property position for vidofludimus calcium. During the quarter, we received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering dose strengths of vidofludimus calcium for the treatment of PMS. This newly allowed patent adds another layer of potential exclusivity protection in the United States, with the option for further term extension." Third Quarter 2025 Highlights September 2025: Presented key data at the 41st Congress of ECTRIMS, highlighting vidofludimus calcium's therapeutic potential in MS, in one oral and four poster presentations, including one late-breaking poster. The results from the phase 2 CALLIPER trial in PMS were also selected for the Best of ECTRIMS 2025 slide deck. The CALLIPER data underscored vidofludimus calcium's neuroprotective potential across PMS populations and its ability to slow disease progression in patients with or without focal inflammation. Consistent 24-week confirmed disability worsening (24wCDW) outcomes were observed across disability endpoints, patient populations and subgroups (including the overall population and in PPMS and naSPMS), and those without baseline inflammatory gadolinium-enhancing (Gd+) lesions during magnetic resonance imaging (MRI). Newly available data regarding 24-week confirmed disability improvement (24wCDI) demonstrated a greater than two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across subtypes. These findings support clinically measurable neuroprotective effects consistent with vidofludimus calcium's Nurr1 activation mechanism and de-risk a potential phase 3 program, as 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS. Long-term data from the phase 2 EMPhASIS OLE period reinforced vidofludimus calcium's robust efficacy signals and favorable safety and tolerability profile, demonstrating that it was well-tolerated for treatment durations of up to 5.5 years in patients with RRMS. Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled ~952 treatment years with an annualized discontinuation rate of only ~6.4%. Most 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. September 2025: Received a Notice of Allowance from the USPTO for patent application 18/529,946, entitled, "Treatment of multiple sclerosis comprising DHODH inhibitors." 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 potential Patent Term Extension may offer additional market exclusivity in the United States. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. IMU-856: The company is preparing for further clinical testing of IMU-856, the orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), contingent on financing, licensing or partnering. Financial and Operating Results Research and Development (R&D) Expenses were $20.0 million for the three months ended September 30, 2025, as compared to $21.4 million for the three months ended September 30, 2024. The $1.4 million decrease reflects (i) a $1.3 million decrease in external development costs related to IMU-856, (ii) a $1.1 million decrease in external development costs related to the completion of the phase 2 CALLIPER trial in the prior year and (iii) a $0.2 million decrease related to costs across numerous categories. The decrease was offset by a $1.2 million increase in personnel expenses for R&D, of which $0.8 million were related to non-cash shared-based compensation. For the nine months ended September 30, 2025, R&D expenses were $63.0 million, as compared to $58.4 million for the nine months ended September 30, 2024. The $4.5 million increase reflects (i) a $6.2 million increase in external development costs related to the phase 3 ENSURE trials and (ii) a $1.6 million increase in personnel expenses for R&D, of which $0.4 million was related to non-cash stock compensation. The increase was offset by (i) a $2.7 million decrease in external development costs related to IMU-856 primarily due to the timing of the purchase of drug supply for this program and (ii) a $0.6 million decrease across numerous categories. General and Administrative (G&A) Expenses were $6.0 million for the three months ended September 30, 2025, as compared to $4.4 million for the same period ended September 30, 2024. The $1.6 million increase was due to (i) a $1.2 million increase in personnel expenses, of which $1.0 million is related to non-cash share-based compensation and (ii) a $0.4 million increase related to costs across numerous categories. For the nine months ended September 30, 2025, G&A expenses were $17.0 million, as compared to $14.0 million for the same period ended September 30, 2024. The $3.0 million increase was due to (i) a $1.8 million increase related to personnel expenses, of which $0.8 million was related to non-cash stock compensation, (ii) a $0.6 million increase in legal and consultancy expenses and (iii) a $0.6 million increase related to costs across numerous categories. Interest Income was $0.4 million for the three months ended September 30, 2025, as compared to $0.8 million for the three months ended September 30, 2024. The $0.4 million decrease was primarily due to a lower average cash balance. For the nine months ended September 30, 2025, interest income was $0.8 million, as compared to $3.0 million for the same period ended September 30, 2024. The $2.1 million decrease was due to a lower average cash balance. In the nine months ended September 30, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the nine months ended September 30, 2025. Other Income (Expense) was negligible for the three months ended September 30, 2025, as compared to $0.6 million for the same period ended September 30, 2024. The $0.6 million decrease was primarily attributable to a decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia. For the nine months ended September 30, 2025, Other Income (Expense) was $1.2 million, as compared to ($1.1 million) for the same period ending September 30, 2024. The $2.3 million increase was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024, (ii) $1.0 million of grant income from the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia. Net Loss for the three months ended September 30, 2025, was approximately $25.6 million, or $0.13 per basic and diluted share, based on 193,897,764 weighted average common shares outstanding, compared to a net loss of approximately $24.4 million, or $0.24 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding for the same period ended September 30, 2024. Net loss for the nine months ended September 30, 2025, was approximately $77.9 million, or $0.55 per basic and diluted share, based on 142,811,489 weighted average common shares outstanding, compared to a net loss of approximately $75.3 million or $0.75 per basic and diluted share, based on 99,998,245 weighted average common shares outstanding for the same period ended September 30, 2024. Cash and Cash Equivalents as of September 30, 2025 were $35.1 million. With this cash, the company does not have adequate liquidity to fund its operations for at least 12 months from September 30, 2025, without raising additional capital. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] Financials SOURCE Immunic, Inc. 21% more press release views with Request a Demo

– Vidofludimus Calcium Demonstrated Statistically Significant 24-Week Confirmed Disability Improvement in Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis, With Over Two-Fold Probability Over Placebo in the Overall Study Population and Consistent Effects Across Subtypes – – CALLIPER Data Showed Positive and Consistent Signals for Slowing Disability Progression Across Disability Endpoints, Patient Populations and Subgroups Without Evidence of Focal Inflammation, Reinforcing the Drug's Neuroprotective Potential and Promise to Slow Disease Progression – – CALLIPER Data Supports Nurr1 Activation as New Mechanism to Prevent Neurodegeneration in Multiple Sclerosis – – Long-Term Data From Phase 2 EMPhASIS Trial in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of 12- and 24-Week Confirmed Disability Worsening as well as Low Discontinuation Rates and Favorable Long-Term Safety and Tolerability – NEW YORK, Sept. 25, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of key data in an oral and four poster presentations, including one late-breaking poster, at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26, 2025 in Barcelona, Spain. The data highlight Immunic's orally available lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium's (IMU-838) therapeutic potential in multiple sclerosis (MS). The presentation and all posters are accessible on the "Events and Presentations" section of Immunic's website at: . "Having such a broad presence at the prestigious ECTRIMS Congress is a major achievement for Immunic and underscores both the strength of our clinical and preclinical data and the potential of vidofludimus calcium to transform the oral MS therapy landscape," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We were especially honored to showcase, in an oral presentation, the positive efficacy and safety data from our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), offering much needed hope for this high unmet medical need patient population." Dr. Vitt continued, "The CALLIPER results, 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 24-week confirmed disability worsening (24wCDW) results across disability endpoints, 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, newly available data regarding 24-week confirmed disability improvement (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 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, additional long-term data from our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) has further reinforced the robust efficacy signals and favorable safety and tolerability observed, to date," concluded Dr. Vitt. "Importantly, our fully enrolled twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for which top-line data is expected by the end of 2026, are designed to evaluate multiple endpoints regarding patient disability. With its unique neuroprotective, anti-inflammatory, and anti-viral profile, along with clean safety and tolerability observed in clinical trials to date, we believe vidofludimus calcium has the potential to become a differentiated oral therapy in the multi-billion-dollar MS market." Oral Presentation: Title: Efficacy and Safety of Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER Trial Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio and Coordinating Investigator of the CALLIPER trial Abstract Number: ECTRIMS25-1404 Presentation ID: O024 Selected for the 'Best of ECTRIMS 2025' slide deck In the overall PMS population (n=467), treatment with vidofludimus calcium reduced the risk of 24wCDW, as assessed by the Expanded Disability Status Scale (EDSS), by 23.8% versus placebo (hazard ratio (HR) 0.762). Among patients without Gd+ lesions at baseline, vidofludimus calcium reduced the risk of 24wCDW by 33.7% overall (HR 0.663). The increase in mean EDSS in the overall PMS population was reduced statistically significant (p<0.05) at 60, 72, 84, 96 and 108 weeks with p<0.01 at 120 weeks. The time to 24wCDI for the overall PMS population demonstrated a statistically significant hazard ratio compared to placebo (n=467, HR 2.441, p=0.034). Further analyses by disease subtype showed that vidofludimus calcium was associated with 24wCDI in the PPMS study population (n=152) compared to placebo (HR 2.823), and in the naSPMS study population (n=268) compared to placebo (HR 1.813). "In the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis patients, we observed consistent trends suggesting a reduction in disability progression across multiple outcomes, patient populations, and subgroups, including those without gadolinium-enhancing lesions at baseline," stated Dr. Fox. "These findings support the hypothesis that Nurr1 activation may represent a novel mechanism to prevent neurodegeneration in MS. Further, vidofludimus calcium demonstrated a favorable safety and tolerability profile, with similar rates of adverse event rates compared to placebo and no new safety signals at the 45 mg once-daily dose. Overall, the CALLIPER trial data support advancing vidofludimus calcium into phase 3 studies for PMS." Late Breaking Poster Presentation: Title: Efficacy and Safety of Vidofludimus Calcium, a Novel Nurr1 Activator and DHODH Inhibitor, in Primary Progressive Multiple Sclerosis (PPMS): Subpopulation Data from the Phase 2 CALLIPER Trial Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio and Coordinating Investigator of the CALLIPER trial Abstract Number: IMS25-LBA-317 Poster Number: P417 In the PPMS subpopulation of the CALLIPER trial, vidofludimus calcium demonstrated trends toward reducing disability progression. Results for 24wCDW based on EDSS showed hazard ratios of 0.687 for the overall PPMS population and 0.656 for the subpopulation of patients without baseline Gd+ lesions. These findings support the potential neuroprotective effects of vidofludimus calcium, likely through Nurr1 activation, and merit further investigation in phase 3 trials. Poster Presentations: Title: 144-Week Analysis of the Confirmed Disability Worsening Events in the Open-Label Treatment Extension of the Phase 2 EMPhASIS Study of Vidofludimus Calcium in Patients with Relapsing-Remitting Multiple Sclerosis Presenting Author: Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic Abstract Number: ECTRIMS25-1587 Poster Number: P814 At week 144 of the phase 2 EMPhASIS open-label extension (OLE) period, 92.3% of patients remained free of 12wCDW and 92.7% remained free of 24wCDW. At 12-weeks following the trigger event, up to week 144, a total of 29 CDW events were confirmed, of which 44.8% were associated with relapse-associated worsening (RAW) and only 13.8% were defined as progression independent of relapse activity (PIRA). Cumulative data from up to 5.5 years of treatment further reinforced vidofludimus calcium's favorable long-term safety and tolerability profile, with low discontinuation rates, low rates of adverse events, and no new safety signals identified. Title: Update on the Assessment of Long-Term Safety and Tolerability of Vidofludimus Calcium in Patients with Relapsing-Remitting Multiple Sclerosis in the Open-Label Extension Period of the Phase 2 EMPhASIS Trial Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio and Coordinating Investigator of the EMPhASIS trial Abstract Number: ECTRIMS25-191 Poster Number: P834 Long-term data from the phase 2 EMPhASIS OLE period 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. Title: Potential Neuroprotective Activity by Vidofludimus Calcium in In Vivo Models of Multiple Sclerosis Presenting Author: Evelyn Peelen, Ph.D., Head of Research at Immunic Abstract Number: ECTRIMS25-1142 Poster Number: P167 In a preclinical mouse model of multiple sclerosis (experimental autoimmune encephalomyelitis, EAE), both prophylactic and therapeutic treatment with vidofludimus calcium effectively attenuated disease severity. Treatment reduced T cell infiltration into the central nervous system (CNS), including decreased number of pathogenic T helper cells producing interleukin-17A (IL-17A), granulocyte-macrophage colony-stimulating factor (GM-CSF), and interferon gamma (IFNγ). Prophylactic dosing also increased expression of Nurr1 target genes in the CNS, elevated plasma brain-derived neurotrophic factor (BDNF) levels, and reduced plasma neurofilament light chain (NfL) levels. In a small EAE pilot study, vidofludimus calcium reduced expression of the microglial activation marker Iba-1 and the neuronal injury marker APP, while increasing expression of the myelin marker MBP. These findings support vidofludimus calcium's potential Nurr1-mediated neuroprotective activity. About Vidofludimus Calcium (IMU-838) Vidofludimus calcium is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis (MS). Uniquely, vidofludimus calcium's first-in-class, dual mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of MS. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for the treatment of relapsing MS. In a phase 2 clinical trial, it has shown therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. Additionally, vidofludimus calcium has demonstrated clinical benefits in progressive MS patients by showing substantial reductions in confirmed disability worsening and thalamic brain volume in a phase 2 clinical trial. To date, vidofludimus calcium has been exposed to approximately 2,700 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the Company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED