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– Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events by 20% in Overall Study Population Compared to Placebo; Even More Prominent 30% Reduction in High Unmet Need Population of Primary Progressive Multiple Sclerosis –– Showed Consistent Reduction of Disability Worsening in Subpopulations Without Inflammatory Lesions at Baseline in Overall Study Population; Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events in Patients Without Gadolinium-Enhancing Lesions at Baseline by 29% Compared to Placebo –&nbsp;– Reduced Annualized Rate of Thalamic Brain Volume Loss by 20% Compared to Placebo –– Confirmed Favorable Safety and Tolerability Observed in Previous Clinical Trials; No New Safety Signals Identified –– Webcast to be Held Today, April 30, at 8:00 am ET –NEW YORK, April 30, 2025 /PRNewswire/ -- <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4416494-1&amp;h=1233229441&amp;u=https%3A%2F%2Fimux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a>&nbsp;(Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced positive data from its phase 2 CALLIPER trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS).&nbsp;Clinical EndpointsIn the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening (24wCDW) events based on changes in the expanded disability status scale (EDSS) by 20% compared to placebo. Further analyses by disease subtype demonstrated that vidofludimus calcium was associated with a 30% reduction in the relative risk of 24wCDW events in the primary progressive multiple sclerosis (PPMS) study population (n=152) compared to placebo and a respective 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) study population (n=268). Reduction of confirmed disability worsening is widely considered to be the most recognized regulatory approval endpoint for registrational studies in progressive forms of multiple sclerosis (MS).&nbsp;Immunic believes that these reductions in 24wCDW events are remarkable in light of the overwhelming non-activity of the CALLIPER population. In support, the evidence of focal inflammatory disease (gadolinium-enhancing lesions at baseline in 6.8% of naSPMS and 17.8% of PPMS patients) and the number of on-study relapses (5.8% in the overall patient population) are lower than in most historical PMS trials.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 by 29% compared to placebo. In historical studies, such&nbsp;patients were largely shown to not benefit from current anti-inflammatory therapies. Immunic believes the substantial effect in these patients, therefore, underlines the previously observed neuroprotective effect of Nurr1 activation by vidofludimus calcium.Magnetic Resonance Imaging (MRI) EndpointsWhile vidofludimus calcium had a modest benefit on the exploratory primary MRI endpoint (annualized rate of percent brain volume change: 5% improvement compared to placebo), vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% in patients with PMS compared to placebo. Change in thalamic volume is considered a more sensitive MRI atrophy marker. Thalamic atrophy is prevalent in PMS and data has shown strong associations with clinical disability progression.&nbsp;The total volume of new or enlarging T2 lesions showed a substantial difference between vidofludimus calcium and placebo&nbsp;over time,&nbsp;with vidofludimus calcium decreasing and placebo increasing (mean percent change, 3.19% benefit for vidofludimus calcium (-0.22%) over placebo (+2.97%) at month 24)."The tremendous reduction of confirmed disability worsening in PMS patients is a wonderful confirmation of the objectives of this exploratory phase 2 trial. CALLIPER was designed 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," said Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We are particularly thrilled to see such a clinically meaningful effect in the PPMS population, with a 30% reduction in the relative risk of 24-week confirmed disability worsening events, which would be the endpoint of a future phase 3 registration study, outperforming historic trials in PPMS regarding numerical reduction of disability progression events. We believe that vidofludimus calcium may represent a novel and exciting approach for people living with PMS, where there continues to be a huge unmet medical need given only one approved therapy. We look forward to discussing these results with healthcare authorities to determine appropriate next steps for vidofludimus calcium in PMS."&nbsp;"The most significant unmet need in MS continues to be the lack of safe and effective therapies that can slow or halt disease progression, especially in PPMS and non-active SPMS. Vidofludimus calcium is the only medicine in development for MS that has been shown to be a potent activator of Nurr1, which plays a key role in neuroprotection. With this unique mode of action, vidofludimus calcium could become the first real neuroprotective treatment option for patients with progressive forms of MS," added Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. "In particular, the 29% reduction of 24-week confirmed disability worsening events for vidofludimus calcium over placebo in the 391 patients without gadolinium-enhancing lesions at baseline underlines the drug's breakthrough potential in addressing the high unmet need of slowing neurodegeneration in MS patients. We believe today's exciting results of the phase 2 CALLIPER trial further validate vidofludimus calcium's scientific rationale, specifically driven by the impressive numerical benefit in reducing disability worsening, which deserves to be further tested in a phase 3 registration trial. Since almost all disability events in a non-active PMS population are known to be progression independent of relapse activity (PIRA), we believe the CALLIPER results also corroborate the benefit on disability progression expected for people suffering from relapsing forms of MS, allowing for a beneficial read-through to our ongoing phase 3 ENSURE trials."&nbsp;Safety and TolerabilityThe top-line CALLIPER data set confirmed the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials. No new safety signals were identified. The occurrence of treatment-emergent adverse events and serious adverse events showed a similar frequency between both treatment arms. The rate of treatment-emergent adverse events was 69.4% of vidofludimus calcium-treated patients compared with 68.5% of patients on placebo. Likewise, serious adverse events were rare and only observed in 8.1% of vidofludimus calcium-treated patients, and in 6.5% of patients on placebo. Additionally, no Hy's law range cases regarding elevations of liver enzymes were observed during the study.&nbsp;About CALLIPERCALLIPER is an international, multicenter, randomized, double-blind, placebo-controlled, exploratory phase 2 trial which enrolled 467 patients at more than 70 sites throughout North America as well as Western, Central and Eastern Europe. Patients, aged 18 to 65 years and without limitation on disease duration,&nbsp;were randomized to either 45 mg daily doses of vidofludimus calcium or placebo and treated for up to 120 weeks. CALLIPER enrolled mainly patients with PPMS (n=152/467) and naSPMS (n=268/467). All patients showed no evidence of relapse in the last 24 months before randomization. For more information, please visit: <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.clinicaltrials.gov/">www.clinicaltrials.gov</a>, NCT05054140.&nbsp;Analysis of the full CALLIPER data set is ongoing and will be presented at upcoming scientific meetings. The company's phase 3 clinical trial program of vidofludimus calcium in relapsing multiple sclerosis is ongoing and expected to be completed in 2026.Webcast Information Immunic will host a webcast today at 8:00 am ET to discuss these results. To participate in the webcast, please register in advance at:&nbsp;<a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4416494-1&amp;h=1348377319&amp;u=https%3A%2F%2Fimux.zoom.us%2Fwebinar%2Fregister%2FWN_tzX8otsFRAawwEmjwgCjeA&amp;a=https%3A%2F%2Fimux.zoom.us%2Fwebinar%2Fregister%2FWN_tzX8otsFRAawwEmjwgCjeA">https://imux.zoom.us/webinar/register/WN_tzX8otsFRAawwEmjwgCjeA</a>&nbsp;or on the "Events and Presentations" section of Immunic's website at: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4416494-1&amp;h=1241921930&amp;u=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations&amp;a=ir.imux.com%2Fevents-and-presentations">ir.imux.com/events-and-presentations</a>.&nbsp;Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.&nbsp;An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4416494-1&amp;h=1241921930&amp;u=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations&amp;a=ir.imux.com%2Fevents-and-presentations">ir.imux.com/events-and-presentations</a>.About Progressive Multiple Sclerosis While multiple sclerosis (MS) in general is an autoimmune disease characterized by immune-mediated demyelination that affects the brain, spinal cord and optic nerve, the progressive phase of the disease seems to be dominated by significant neurodegenerative mechanisms. Progressive multiple sclerosis (PMS) is a clinical form of MS characterized by gradual accrual of disability independent of relapses over time. PMS includes both 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. SPMS is identified following an initial relapsing-remitting course, after which the disease becomes more steadily progressive, with (active SPMS) or without (non-active SPMS) MRI lesions and/or relapses present.&nbsp;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 and phase 2 clinical trials for the treatment of relapsing and progressive MS, respectively. In a phase 2 clinical trial, it has shown therapeutic activity in patients suffering from relapsing-remitting MS, significantly reducing MRI 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 the relative risks of 24-week confirmed disability progression events and in 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.&nbsp;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, which are expected to be completed in 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: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4416494-1&amp;h=2181408004&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=www.imux.com">www.imux.com</a>.&nbsp;Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials 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 <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.sec.gov/">www.sec.gov</a> 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.&nbsp;Contact InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-announces-vidofludimus-calcium-reduced-risk-of-disability-worsening-by-30-in-primary-progressive-multiple-sclerosis-patients-from-phase-2-calliper-trial-302442274.html">https://www.prnewswire.com/news-releases/immunic-announces-vidofludimus-calcium-reduced-risk-of-disability-worsening-by-30-in-primary-progressive-multiple-sclerosis-patients-from-phase-2-calliper-trial-302442274.html</a>SOURCE Immunic, Inc. &nbsp;

Immunic Announces Vidofludimus Calcium Reduced Risk of Disability Worsening by 30% in Primary Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial

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NEW YORK, May 2, 2025 /PRNewswire/ --&nbsp;<a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4417130-1&amp;h=2471452423&amp;u=https%3A%2F%2Fimux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a>&nbsp;(Nasdaq: IMUX),&nbsp;a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in May:&nbsp;<ul><li>May 3-6:&nbsp;Digestive Disease Week (DDW). Two abstracts discussing Immunic's phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, have been accepted for poster presentations at this conference in&nbsp;San Diego, CA. &nbsp;<ul><li>Poster Title:&nbsp;IMU-856 vs. Placebo Efficacy Effects in Celiac Disease Patients Are Independent of Q-MARSH Scale at Baseline</li><li>Abstract ID:&nbsp;4216653</li><li>Poster Number:&nbsp;Tu1329</li><li>Presenting Author:&nbsp;Indira Pichetto Olanda, M.D., Associate Medical Manager, Immunic</li><li>Session:&nbsp;Enteropathies — Celiac, Gluten Related and Environmental</li><li>Session Date:&nbsp;Tuesday, May 6, 2025</li><li>Session Time:&nbsp;12:30 – 1:30 pm PDT &nbsp;</li><li>Poster Title:&nbsp;Influence of Gut Epithelial Condition on the Pharmacokinetic Properties of IMU-856, an Oral Regulator of Barrier Function for the Treatment of Celiac Disease</li><li>Abstract ID:&nbsp;4219364</li><li>Poster Number:&nbsp;Tu1344</li><li>Presenting Author:&nbsp;Jacques Arend, M.D., Head of Clinical Pharmacology, Immunic</li><li>Session:&nbsp;Enteropathies — Celiac, Gluten Related and Environmental</li><li>Session Date:&nbsp;Tuesday, May 6, 2025</li><li>Session Time:&nbsp;12:30 – 1:30 pm PDT &nbsp;</li></ul></li><li>May 13-15:&nbsp;Clinical Trial Supply Forum 2025. Kimi Oanh Le, Head of Clinical Trial Supply at Immunic, will discuss the clinical trial supply chain challenges working across the Middle East and North Africa(MENA) at this forum in Brussels, Belgium. &nbsp;<ul><li>Presentation Type:&nbsp;Case Study</li><li>Case Study Title:&nbsp;Immunic Therapeutics Supply Chain Challenges Working Across MENA</li><li>Date:&nbsp;Wednesday, May 14, 2025</li><li>Time:&nbsp;10:40 am CEST (4:40 am EDT) &nbsp;</li></ul></li><li>May 28-31:&nbsp;Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025. Members of Immunic's management, medical and preclinical teams will attend this meeting in Phoenix, AZ. The team will be available throughout the event at booth #911. Additionally, preclinical data highlighting lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), will be presented in a poster presentation. &nbsp;<ul><li>Poster Title:&nbsp;In Preclinical Models, Vidofludimus Calcium Exhibits Potential Neuroprotective Effects in Multiple Sclerosis by Modulating Nurr1</li><li>Presenting Author:&nbsp;Amelie Schreieck, Ph.D., Senior Manager Biomarker Development, Immunic</li><li>Abstract ID:&nbsp;10271</li><li>Poster Board Label:&nbsp;NDM01</li><li>Date:&nbsp;Thursday, May 29, 2025</li><li>Time:&nbsp;5:00 – 7:00 pm MST</li></ul></li></ul>All presentations will be accessible on the "Events and Presentations" section of Immunic's website at: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4417130-1&amp;h=1645169867&amp;u=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations&amp;a=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations">https://ir.imux.com/events-and-presentations</a>.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, which are expected to be completed in 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: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4417130-1&amp;h=1489726594&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=www.imux.com">www.imux.com</a>.&nbsp;Cautionary Statement Regarding Forward-Looking StatementsThis 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 management's and employee's participation in scientific and industry conferences. 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 <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.sec.gov/">www.sec.gov</a> 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.&nbsp;Contact InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-to-participate-in-scientific-and-industry-conferences-in-may-302444030.html">https://www.prnewswire.com/news-releases/immunic-to-participate-in-scientific-and-industry-conferences-in-may-302444030.html</a>SOURCE Immunic, Inc.

Immunic to Participate in Scientific and Industry Conferences in May

NEW YORK, May 28, 2025 /PRNewswire/ -- <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4437419-1&amp;h=4199890651&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a> ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that it has commenced an underwritten public offering of (i) pre-funded warrants to purchase shares of common stock, (ii) Series A warrants to purchase shares of common stock (or pre-funded warrants) expiring on December 31, 2025, (iii) and Series B warrants to purchase shares of common stock (or pre-funded warrants) expiring five years following the issuance date. The Series A and B warrants will&nbsp;immediately&nbsp;expire in&nbsp;proportion&nbsp;to&nbsp;the&nbsp;extent that&nbsp;the corresponding&nbsp;pre-funded&nbsp;warrant&nbsp;offered&nbsp;hereby is&nbsp;exercised&nbsp;on&nbsp;or&nbsp;prior to&nbsp;September&nbsp;30,&nbsp;2025, subject to certain exceptions. All of the securities to be sold in the proposed offering will be offered by Immunic. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.&nbsp;The Company intends to use the net proceeds received from the proposed offering to fund its clinical trials and operations and for other general corporate purposes.Leerink Partners is acting as the sole bookrunner for the offering.The offering is being made by Immunic pursuant to a shelf registration statement on Form S-3 (File No. 333-275717), as amended, initially filed with the Securities and Exchange Commission (the "SEC") on November 22, 2023, which became effective on May 31, 2024. The offering is being made only by means of a preliminary prospectus supplement and the accompanying base prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying base prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4437419-1&amp;h=4102798762&amp;u=https%3A%2F%2Fwww.sec.gov%2F&amp;a=www.sec.gov">www.sec.gov</a>. Copies of the preliminary prospectus supplement and the accompanying base prospectus, and when available, copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, may be obtained by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:syndicate@leerink.com">syndicate@leerink.com</a>.&nbsp;This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.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 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.&nbsp;Cautionary Note Regarding Forward-Looking StatementsThis 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 consummation of the proposed offering as well as the timing and size of the proposed offering, Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials 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, the Company's ability to close the proposed public offering, and the risk that warrants issued in this offering will not be exercised for cash in the future. 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 <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4437419-1&amp;h=4102798762&amp;u=https%3A%2F%2Fwww.sec.gov%2F&amp;a=www.sec.gov">www.sec.gov</a>&nbsp;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.&nbsp;Contact InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-inc-announces-proposed-public-offering-302467606.html">https://www.prnewswire.com/news-releases/immunic-inc-announces-proposed-public-offering-302467606.html</a>SOURCE Immunic, Inc.

Immunic, Inc. Announces Proposed Public Offering

NEW YORK, May 29, 2025 /PRNewswire/ -- <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4437443-1&amp;h=2153320783&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a> ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the pricing of an underwritten public offering of (i) pre-funded warrants to purchase shares of common stock (the "Pre-Funded Warrants"), (ii) series A warrants to purchase shares of common stock (or pre-funded warrants) (the "Series A Warrants"), and (iii) series B warrants to purchase shares of common stock (or pre-funded warrants) (the "Series B Warrants"). The combined public offering price of one Pre-Funded Warrant, one Series A Warrant, and one Series B Warrant, which are being sold together but are immediately seperable, is $0.7499. The Pre-Funded Warrants will be immediately exercisable, and may be exercised at any time after their original issuance. The Series A Warrants will be immediately exercisable any time before December 31, 2025. The Series B Warrants will be exercisable beginning on October 1, 2025, or earlier if certain thresholds are met, until five years from the date of issuance. The Series A and B Warrants will immediately expire in proportion to the extent that the corresponding pre-funded warrant offered hereby is exercised on or prior to September 30, 2025, subject to certain exceptions.All securities in the offering are being sold by Immunic.The initial gross proceeds from the offering are expected to be approximately $65 million before deducting underwriting discounts and commissions and offering expenses. The Company may receive up to an aggregate of $130 million of additional gross proceeds if the Series A Warrants and Series B Warrants are exercised in full for cash. The offering is expected to close on or about June 3, 2025, subject to the satisfaction of customary closing conditions.The Company intends to use the net proceeds received from the proposed offering to fund its clinical trials and operations and for other general corporate purposes.Leerink Partners is acting as the sole bookrunner for the offering. B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-managers and William Blair &amp; Company, L.L.C. is acting as financial advisor to the Company.The offering is being made by Immunic pursuant to a shelf registration statement on Form S-3 (File No. 333-275717) previously filed with the Securities and Exchange Commission (the "SEC") on November 22, 2023, which became effective on May 31, 2024. The offering is being made only by means of a prospectus supplement and the accompanying base prospectus that form a part of the registration statement. A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4437443-1&amp;h=2391249470&amp;u=https%3A%2F%2Fwww.sec.gov%2F&amp;a=www.sec.gov">www.sec.gov</a>. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may be obtained by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:syndicate@leerink.com">syndicate@leerink.com</a>.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.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 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.&nbsp;Cautionary Note Regarding Forward-Looking StatementsThis 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 consummation of the proposed offering, Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials 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, the Company's ability to close the proposed public offering, and the risk that warrants issued in this offering will not be exercised for cash in the future. 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 <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.sec.gov/">www.sec.gov</a> 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 InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-inc-announces-pricing-of-oversubscribed-65-million-underwritten-public-offering-302468224.html">https://www.prnewswire.com/news-releases/immunic-inc-announces-pricing-of-oversubscribed-65-million-underwritten-public-offering-302468224.html</a>SOURCE Immunic, Inc.

Immunic, Inc. Announces Pricing of Oversubscribed $65 Million Underwritten Public Offering

NEW YORK, June 2, 2025 /PRNewswire/ --&nbsp;<a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4438906-1&amp;h=2826277310&amp;u=https%3A%2F%2Fimux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a>&nbsp;(Nasdaq: IMUX),&nbsp;a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following investor, scientific and industry conferences in June:<ul><li>June 3-5:&nbsp;Jefferies Healthcare Conference. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will present a company overview on Thursday, June 5, 2025 at 4:55 pm ET at this conference in New York. A webcast will be available on the "Events and Presentations" section of Immunic's website at: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4438906-1&amp;h=1496679026&amp;u=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations&amp;a=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations">https://ir.imux.com/events-and-presentations</a>. Dr. Vitt,&nbsp;Jason Tardio, President and Chief Operating Officer, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Jefferies representative or Jessica Breu at: <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>.</li></ul>&nbsp;<ul><li>June 10-13:&nbsp;4th RSC Anglo-Nordic Medicinal Chemistry Symposium. Christian Gege, Ph.D., Head of Intellectual Property at Immunic, will present preclinical data highlighting antiviral candidates based on lead asset vidofludimus calcium (IMU-838) in a flash talk and a poster presentation&nbsp;at this symposium in Snekkersten, Denmark.<ul><li>Poster Title:&nbsp;DHODH Inhibitors Containing Carboxylic Acid Bioisosters With Superior Broad-Spectrum Antiviral Activity for Next Pandemic Preparedness</li><li>Poster/Flash Talk Number:&nbsp;P18/FT18</li><li>Poster Session:&nbsp;Displayed&nbsp;throughout the event</li><li>Flash Talk Session Date:&nbsp;Wednesday, June 11, 2025</li><li>Flash Talk Session Time:&nbsp;1:45 pm – 2:30 pm CET (7:45 am – 8:30 am ET) &nbsp;</li></ul></li><li>June 11:&nbsp;UBS Life Sciences Conference. Dr. Vitt and Ms. Breu will attend this conference in London, UK. To schedule a meeting, please contact Jessica Breu at: <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>. &nbsp;</li><li>June 16-19:&nbsp;BIO International Convention 2025. Members of Immunic's management and business development teams will participate in partnering activities at this convention in Boston. To schedule a meeting, please use the <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4438906-1&amp;h=836210529&amp;u=https%3A%2F%2Fconvention.bio.org%2Fpartner%3Fgad_source%3D1%26gclid%3DCj0KCQjw_-https%3A%2F%2Fconvention.bio.org%2Fpartner%3Fgad_source%3D1%26gclid%3DCj0KCQjw_-GxBhC1ARIsADGgDjvLmuTpHE9zudZw2gTW1WH3Bl7mVEZsJwUyxE9kfMGyP6fzQiaPj84aAksyEALw_wcB_wcB&amp;a=BIO+International+Convention+partnering+portal">BIO International Convention partnering portal</a>, or contact Jessica Breu at: <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>. &nbsp;</li><li>June 21-24:&nbsp;11th Congress of the European Academy of Neurology (EAN) – Helsinki 2025. Members of Immunic's management, medical and preclinical teams will attend this congress in Helsinki, Finland. The team will be available throughout the event at booth #E38. Additionally, data highlighting nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), will be presented in an ePresentation session.<ul><li>Poster Title:&nbsp;Vidofludimus Calcium Shows Potential Neuroprotective Effects in an In Vivo Multiple Sclerosis Model by Nurr1 Modulation</li><li>Presenting Author:&nbsp;Evelyn Peelen, Ph.D., Head of Research at Immunic</li><li>Abstract ID:&nbsp;A-25-14987</li><li>ePresentation Number: EPR-265</li><li>Session Name:&nbsp;MS and Related Disorders 3</li><li>Session Date:&nbsp;Monday, June 23, 2025</li><li>Session Time:&nbsp;2:00 pm – 2:45 pm EEST (7:00 am – 7:45 am ET) &nbsp;</li></ul></li><li>June 23-25:&nbsp;Accelerating Bio-Innovation (ABI) Conference 2025. Dr. Vitt and Mr. Tardio will attend this conference, organized in partnership with Royalty Pharma, in Cambridge, MA.</li></ul>All presentations will be accessible on the "Events and Presentations" section of Immunic's website at: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4438906-1&amp;h=1496679026&amp;u=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations&amp;a=https%3A%2F%2Fir.imux.com%2Fevents-and-presentations">https://ir.imux.com/events-and-presentations</a>.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 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: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4438906-1&amp;h=1676780091&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=www.imux.com">www.imux.com</a>.Cautionary Statement Regarding Forward-Looking StatementsThis 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 management's and employee's participation in investor, scientific and industry conferences. 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 <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.sec.gov/">www.sec.gov</a> 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 InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-to-participate-in-investor-scientific-and-industry-conferences-in-june-302469435.html">https://www.prnewswire.com/news-releases/immunic-to-participate-in-investor-scientific-and-industry-conferences-in-june-302469435.html</a>SOURCE Immunic, Inc.

Immunic to Participate in Investor, Scientific and Industry Conferences in June

NEW YORK, June 3, 2025 /PRNewswire/ -- <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4441435-1&amp;h=2142729775&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a> ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the closing of its previously announced underwritten public offering of (i) pre-funded warrants to purchase shares of common stock (the "Pre-Funded Warrants"), (ii) series A warrants to purchase shares of common stock (or pre-funded warrants) (the "Series A Warrants"), and (iii) series B warrants to purchase shares of common stock (or pre-funded warrants) (the "Series B Warrants").The Pre-Funded Warrants are immediately exercisable, and may be exercised at any time after their original issuance. The Series A Warrants are immediately exercisable any time after their original issuance until December 31, 2025. The Series B Warrants will be exercisable beginning on October 1, 2025, or earlier if certain thresholds are met, until June 3, 2030. The Series A and B Warrants will immediately expire in proportion to the extent that the corresponding Pre-Funded Warrant offered hereby is exercised on or prior to September 30, 2025, subject to certain exceptions.The initial proceeds to Immunic from the offering were approximately $65 million, before deducting underwriting discounts and commissions and offering expenses. The Company may receive up to an aggregate of $130 million of additional proceeds if the Series A Warrants and Series B Warrants are exercised in full for cash.The financing was co-led by BVF Partners and Coastlands Capital, and included participation from Aberdeen Investments, Adage Capital Partners LP, Janus Henderson Investors, and other institutional investors.Leerink Partners acted as the sole bookrunner for the offering. B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-managers, and William Blair &amp; Company, L.L.C. served as financial advisor to the Company.The Company intends to use the net proceeds from the offering to&nbsp;fund&nbsp;its&nbsp;clinical&nbsp;trials&nbsp;and&nbsp;operations&nbsp;and&nbsp;for&nbsp;other general corporate purposes.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.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 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.Cautionary Note Regarding Forward-Looking StatementsThis 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 the receipt of additional proceeds from the offering if the Series A Warrants and Series B Warrants are exercised in full for cash, Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials 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, the risk that warrants issued in this offering will not be exercised for cash in the future. 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 <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4441435-1&amp;h=1902769502&amp;u=https%3A%2F%2Fwww.sec.gov%2F&amp;a=www.sec.gov">www.sec.gov</a>&nbsp;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 InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartzs +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-inc-announces-closing-of-oversubscribed-65-million-underwritten-public-offering-302472318.html">https://www.prnewswire.com/news-releases/immunic-inc-announces-closing-of-oversubscribed-65-million-underwritten-public-offering-302472318.html</a>SOURCE Immunic, Inc.

Immunic, Inc. Announces Closing of Oversubscribed $65 Million Underwritten Public Offering

– Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 –– Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential –– New CALLIPER Data Regarding Time to 24-Week Confirmed Disability Worsening Shows Substantial and Medically Relevant Reductions for Vidofludimus Calcium Over Placebo in the Overall Study Population and Major Disease Subtypes –NEW YORK, June 5, 2025 /PRNewswire/ -- <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4443060-1&amp;h=4233216002&amp;u=https%3A%2F%2Fimux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a>&nbsp;(Nasdaq: IMUX),&nbsp;a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced the completion of enrollment for both phase 3 ENSURE trials of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing multiple sclerosis and additional phase 2 CALLIPER trial data in patients with progressive multiple sclerosis underlining the recently released positive top-line results.Enrollment Completed for Both Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis (RMS)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 magnetic resonance imaging (MRI)-based endpoints."The on-schedule enrollment of the final patients in our phase 3 ENSURE trials of&nbsp;vidofludimus calcium marks another significant milestone for our late-stage MS program, bringing us meaningfully closer to a potential new treatment option for people living with RMS," commented Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We anticipate that the drug's unique neuroprotective effects observed to date will also play a crucial role in the ENSURE trials, where confirmed disability worsening serves as an important secondary outcome. If approved, we believe vidofludimus calcium, with its attractive safety and tolerability profile, compelling dual and novel mechanism of action and combination of neuroprotective, anti-inflammatory, and antiviral effects, could potentially transform the oral MS therapy market, offering a unique first-in-class treatment option by addressing the full spectrum of this disease. We eagerly anticipate the top-line data from both ENSURE trials by the end of 2026, which allows for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint."Werner Gladdines, Chief Development Officer of Immunic, added, "We are extremely proud to have reached this key milestone for our ENSURE program of vidofludimus calcium, right on schedule. Successfully completing enrollment of over 2,200 RMS patients across the twin phase 3 trials represents a major achievement and a true team effort. We extend our sincere thanks to all Immunic colleagues and vendor staff involved in the planning and execution of the ENSURE trials for their dedication to advancing our late-stage clinical program. We are also deeply grateful for the strong support from our clinical investigators, site study teams, and the study participants and their families. We look forward to analyzing the ENSURE top-line data, which we hope will ultimately pave the way for regulatory filings and the ultimate commercialization of vidofludimus calcium in RMS."Additional Data Available from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis (PMS)Building on the recently released data showing reductions in the relative risk of 24-week confirmed disability worsening (24wCDW) events based on the Expanded Disability Status Scale (EDSS) at the end of the main treatment period, newly available data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforces the neuroprotective potential of vidofludimus calcium. In the overall PMS patient population (n=467), vidofludimus calcium demonstrated a clinically meaningful reduction of the hazard ratio (HR) for 24wCDW by 24% compared to placebo (HR 0.76). Further analyses by disease subtype showed that vidofludimus calcium was associated with a 33% reduction in 24wCDW in the primary progressive multiple sclerosis (PPMS) study population (n=152) compared to placebo (HR 0.67), a 19% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) study population (n=268) compared to placebo (HR 0.81), and a 34% reduction in the active secondary progressive multiple sclerosis (aSPMS) study population (n=47) compared to placebo (HR 0.66).Similarly, consistent with the recent 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 population, vidofludimus calcium reduced 24wCDW in patients without evidence of gadolinium-enhancing lesions at baseline by 34% compared to placebo (HR 0.66). Encouraging results were likewise observed for the PPMS (reduction in 24wCDW: 35%; HR 0.65) and naSPMS (reduction in 24wCDW: 30%; HR 0.70) study populations compared to placebo."Our recently released positive phase 2 CALLIPER trial data in PMS underlined vidofludimus calcium's neuroprotective potential and its ability to slow disease progression in MS patients with or without focal inflammation. We are very excited that additional analyses of time to 24-week confirmed disability worsening further support this potential, highlighting a significant opportunity ahead," stated Dr. Vitt. "The consistent results for 24wCDW between the general CALLIPER population and patients that show no evidence of focal inflammatory disease at baseline, as exemplified by gadolinium-enhancing lesions during MRI, both for the overall study population and for the PPMS and naSPMS subtypes, supports clinically measurable neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism. We believe, because 24wCDW is an acceptable regulatory endpoint to determine clinical benefit in PMS, the suggestive evidence of clinical activity in 24wCDW clearly deserves further investigation in a phase 3 program."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: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4443060-1&amp;h=936768391&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=www.imux.com">www.imux.com</a>.Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials 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 <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.sec.gov/">www.sec.gov</a> 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 InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-announces-completion-of-enrollment-for-both-phase-3-ensure-trials-in-relapsing-ms-and-presents-additional-data-underlining-positive-outcome-of-phase-2-calliper-trial-in-progressive-ms-302474152.html">https://www.prnewswire.com/news-releases/immunic-announces-completion-of-enrollment-for-both-phase-3-ensure-trials-in-relapsing-ms-and-presents-additional-data-underlining-positive-outcome-of-phase-2-calliper-trial-in-progressive-ms-302474152.html</a>SOURCE Immunic, Inc.

Immunic Announces Completion of Enrollment for Both Phase 3 ENSURE Trials in Relapsing MS and Presents Additional Data Underlining Positive Outcome of Phase 2 CALLIPER Trial in Progressive MS

– At Week 144, 92.3% of Patients Remained Free of 12-Week Confirmed Disability Worsening (CDW) With 92.7% Remaining Free of 24-Week CDW –– Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years –NEW YORK, June 24, 2025 /PRNewswire/ --&nbsp;<a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4454704-1&amp;h=49307920&amp;u=https%3A%2F%2Fimux.com%2F&amp;a=Immunic%2C+Inc.">Immunic, Inc.</a>&nbsp;(Nasdaq: IMUX),&nbsp;a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today reported new long-term open-label extension (OLE) data from its phase 2 EMPhASIS trial of lead asset,&nbsp;orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS)."It is meaningful to see that patients treated with vidofludimus calcium during the OLE period of our phase 2 EMPhASIS trial in RRMS experienced&nbsp;a low rate of confirmed disability worsening (CDW) events, as measured by the Expanded Disability Status Scale (EDSS). This data, representing approximately 952 treatment years, further underlines our belief that vidofludimus calcium holds great potential to&nbsp;effectively manage the disease, help preserve neurological function, allow patients to maintain independence and improve long-term quality of life," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic.The data at week 144 showed that 92.3% of patients remained free of 12-week CDW, and 92.7% free of 24-week CDW. 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,&nbsp;no new safety signals have emerged during treatment durations up to 5.5 years."This new data from the OLE period is very encouraging and continues to corroborate the prior strong results we observed in our phase 2 EMPhASIS trial in RRMS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The ability to maintain remarkably low rates of disability progression is among the most important unmet needs in relapsing MS despite the availability of multiple anti-inflammatory drugs approved for the treatment of MS relapses. By delaying disease progression, MS patients maintain greater independence, face a lower burden in managing their symptoms and experience more favorable long-term outcomes.""Additionally, previously announced data across our multiple sclerosis (MS) program, including from the EMPhASIS trial as well as our recent top-line data from the phase 2 CALLIPER trial in progressive multiple sclerosis, has further highlighted vidofludimus calcium's&nbsp;potential to slow disease progression in MS and substantiated its neuroprotective capabilities through the activation of the Nurr1 target. As a reminder, despite 30-years of commercially available MS treatments, slowing and preventing disease progression still remains a critical unmet need. Based on the data we have generated, to date, we continue to believe that vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects as well as its established, highly favorable safety and tolerability profile, could represent a unique new oral therapy targeted to the complex pathophysiology of MS."The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS. The trial randomized 268 RRMS patients and included a 24-week blinded main treatment period testing 10, 30 and 45 mg of vidofludimus calcium and placebo. The trial achieved both primary and key secondary endpoints with high statistical significance and showed a favorable safety and tolerability profile similar to placebo. The trial 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. Patients were initially given&nbsp;either 30 mg or 45 mg of vidofludimus calcium once-daily,&nbsp;following which all patients received 30 mg of vidofludimus calcium once-daily.&nbsp;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.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: <a target="_blank" rel="noopener noreferrer nofollow" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4454704-1&amp;h=3379843733&amp;u=http%3A%2F%2Fwww.imux.com%2F&amp;a=www.imux.com">www.imux.com</a>.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 <a target="_blank" rel="noopener noreferrer nofollow" href="http://www.sec.gov/">www.sec.gov</a> 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 InformationImmunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:jessica.breu@imux.com">jessica.breu@imux.com</a>US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:immunic@rxir.com">immunic@rxir.com</a>US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:ckasunich@kcsa.com">ckasunich@kcsa.com</a>View original content to download multimedia:<a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-reports-new-positive-long-term-open-label-extension-data-from-phase-2-emphasis-trial-of-vidofludimus-calcium-in-relapsing-remitting-multiple-sclerosis-302489105.html">https://www.prnewswire.com/news-releases/immunic-reports-new-positive-long-term-open-label-extension-data-from-phase-2-emphasis-trial-of-vidofludimus-calcium-in-relapsing-remitting-multiple-sclerosis-302489105.html</a>SOURCE Immunic, Inc.

Immunic Reports New, Positive Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis

Shares of biotechnology company Immunic, Inc. (IMUX) drew investor attention on Wednesday morning after the company <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/immunic-inc-announces-pricing-of-5-1-million-registered-direct-offering-led-by-aberdeen-investments-302424493.html">announced</a> it is looking to raise about $5.1 million through a registered direct offering led by Aberdeen Investments.The company said it would sell 5.67 million shares of its common stock at $0.90 per share, or its closing price on Tuesday.Immunic intends to use the net proceeds from the proposed offering to fund its clinical trials and operations and for other general corporate purposes. The offering is expected to close on or about April 10.Earlier this year, Immunic, which is developing a clinical pipeline of orally administered, small-molecule therapies for chronic inflammatory and autoimmune diseases, said that it expects to be able to fund its operations into the third quarter of 2025.As of September 30, 2024, the company had cash and cash equivalents of $59.1 million.The firm’s lead development program, Vidofludimus Calcium, is currently in phase 3 and phase 2 clinical trials for treating relapsing and progressive multiple sclerosis, respectively.On Stocktwits, retail sentiment around Immunic dipped marginally into ‘neutral’ territory, coupled by a six-point drop in message volume over the past 24 hours.<figure class="image"><img style="aspect-ratio:656/150;" src="https://news.stocktwits-cdn.com/Screenshot_2025_04_09_at_9_34_18_AM_png_e87fdead14.webp" alt="IMUX's Sentiment Meter and Message Volume as of 9:30 a.m. ET on April 8, 2025 | Source: Stocktwits" width="656" height="150"><figcaption>IMUX's Sentiment Meter and Message Volume as of 9:30 a.m. ET on April 9, 2025 | Source: Stocktwits</figcaption></figure> A Stocktwits user expressed doubt about the company raising millions before providing data from its ongoing trials.<stembedurl>https://stocktwits.com/Biomover/message/611022835</stembedurl>Another said IMUX will do well if it registers positive trial data this month.<stembedurl>https://stocktwits.com/Share54321/message/611022348</stembedurl><a href="https://stocktwits.com/symbol/IMUX">IMUX shares</a> have been down by nearly 12% this year and by over 30% over the past 12 months.Also See: <a href="https://stocktwits.com/news-articles/markets/equity/bristol-myers-wins-dismissal-of-class-action-lawsuit-accusing-it-of-fradulent-patents/chfnEWNRbJ6">Bristol Myers Wins Dismissal Of Class Action Lawsuit Accusing It Of Fraudulently Acquiring Patents – Retail Sentiment Remains Subdued</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

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Immunic Stock Draws Investor Attention On $5.1M Registered Direct Offering: Retail’s On Wait-And-Watch Mode 

Immunic intends to use the net proceeds from the proposed offering to fund its clinical trials and operations and for other general corporate purposes.

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Immunic intends to use the net proceeds from the proposed offering to fund its clinical trials and operations and for other general corporate purposes.


Immunic Presents Key Vidofludimus Calcium Data at the ACTRIMS Forum 2025, Highlighting Its Potential in Multiple Sclerosis

Immunic Presents Key Vidofludimus Calcium Data at the ACTRIMS Forum 2025, Highlighting Its Potential in Multiple Sclerosis Immunic Presents Key Vidofludimus Calcium Data at the ACTRIMS Forum 2025...

Immunic, Inc. is a clinical-stage biopharmaceutical company, which develops a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases. It focuses on multiple sclerosis, celiac disease and other neurologic and gastrointestinal disorders. The firm's products include IMU-838, IMU-856, and IMU-381. The company was founded in 2016 and is headquartered in New York, NY.

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