IMUX

Immunic Inc (NASDAQ:IMUX, FRA:10VA) is preparing for a series of clinical and corporate milestones as it advances its lead drug candidate vidofludimus calcium through late-stage development in multiple sclerosis, while expanding its leadership team ahead of potential regulatory filings and commercialization. The biotechnology company reported second-quarter results on Tuesday and said its Phase 3 ENSURE-1 and ENSURE-2 trials evaluating vidofludimus calcium in relapsing multiple sclerosis remain on track to deliver top-line data by the end of 2026. If the results are positive, Immunic plans to submit a New Drug Application in the US in mid-2027, with a potential regulatory decision targeted for 2028. The company is also preparing to begin a Phase 3 program evaluating vidofludimus calcium in progressive multiple sclerosis later this year. The planned study follows data from the Phase 2 CALLIPER trial, including analyses presented at the 2026 Consortium of Multiple Sclerosis Centers annual meeting that covered disability progression, patient-reported outcomes, safety and tolerability. Immunic has also made several changes to its management and board as it moves toward potential commercialization. Erik Lundgren was appointed CEO in May and joined the board in July, while Michael Panzara became chief medical officer in April. Michael Bonney was appointed chair of the board in May, and Elena Ridloff joined the board in August. For the second quarter, Immunic reported total operating expenses of $35.3 million, up from $27 million a year earlier. Research and development expenses rose to $25.9 million from $21.3 million, with the increase primarily reflecting higher personnel expenses and drug-drug interaction studies supporting a potential regulatory filing. General and administrative expenses increased to $9.4 million from $5.7 million, driven by higher personnel, legal and consulting costs and pre-commercial marketing expenses. The company reported a second quarter net loss of approximately $34.1 million, or $0.80 per basic and diluted share, compared with a net loss of $26.8 million, or $2.03 per share, in the year-earlier period. The lower per-share loss reflected a higher weighted-average share count. Immunic ended the quarter with $155.1 million in cash and cash equivalents and said it expects those funds to support operations into late 2027. Immunic CEO Erik Lundgren said the company had continued to execute on its late-stage development priorities and had strengthened its board and management team with multiple sclerosis development, medical, regulatory and commercialization expertise. “Following the successful closing of our oversubscribed private placement financing earlier this year, we are well capitalized to execute on our key strategic priorities,” Lundgren said. “We believe the milestones ahead position Immunic for a significant near-term value inflection for vidofludimus calcium in relapsing MS, while continuing to unlock the substantial long-term opportunity across the broader progressive MS patient population.” Michael Panzara, Immunic's chief medical officer, highlighted that the ENSURE trials remain on track for year-end data and said the company is preparing for a potential regulatory submission if the trials produce positive results. "With regulatory alignment and precedent surrounding the time to first relapse primary endpoint, the path to regulatory submission upon positive trial results is clear,” Panzara said. “In parallel, we are preparing to initiate our Phase 3 progressive MS trial later this year, reinforcing our commitment to evaluating the potential of vidofludimus calcium for anyone living with MS."

– Leadership Team Expanded with Key Executive Appointments, Including Chief Executive Officer, Chief Medical Officer and Chair of the Board of Directors, to Support Clinical Development, as well as NDA and Commercial Readiness – – Pivotal Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis on Track, with Top-Line Data Expected by End of 2026 – – Continued Preparations for Phase 3 Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis, with Initiation Planned Later This Year – NEW YORK, Aug. 11, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. "During the second quarter, we continued to execute across our late-stage development priorities as we advance toward what we believe will be a transformational period for Immunic," said Erik Lundgren, Chief Executive Officer of Immunic. "As we prepare for the next stage of Immunic's growth, we have continued to strengthen our board and team with world-class multiple sclerosis (MS) experts whose extensive development, medical, regulatory and commercialization expertise will be instrumental as we execute on our clinical strategy and prepare for the potential regulatory filings and commercialization of vidofludimus calcium (IMU-838). Following the successful closing of our oversubscribed private placement financing earlier this year, we are well capitalized to execute on our key strategic priorities. We believe the milestones ahead position Immunic for a significant near-term value inflection for vidofludimus calcium in relapsing MS, while continuing to unlock the substantial long-term opportunity across the broader progressive MS patient population." Jason Tardio, President and Chief Operating Officer of Immunic, commented, "We remain highly encouraged by the consistent and differentiated profile of vidofludimus calcium, supported by additional data from our Phase 2 CALLIPER trial in progressive MS presented at this year's CMSC Annual Meeting, including favorable safety, tolerability, patient-reported, and exploratory efficacy data. Taken together, these findings reinforce our confidence in the potential of vidofludimus calcium to offer a differentiated benefit/risk profile through its novel dual mechanism of action, combining Nurr1 activation with selective DHODH inhibition. We believe this approach has the potential to deliver meaningful efficacy while maintaining the favorable safety and tolerability profile observed to date, positioning vidofludimus calcium as a potentially important new oral treatment option for people living with MS." "Our Phase 3 ENSURE trials of vidofludimus calcium in relapsing MS remain on track to report top-line data by the end of 2026," added Michael A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. "With regulatory alignment and precedent surrounding the time to first relapse primary endpoint, the path to regulatory submission upon positive trial results is clear. In parallel, we are preparing to initiate our Phase 3 progressive MS trial later this year, reinforcing our commitment to evaluating the potential of vidofludimus calcium for anyone living with MS." Second Quarter 2026 and Subsequent Highlights Ongoing Phase 3 ENSURE Relapsing MS Program: Continued to execute the twin Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing MS. Preparation of Phase 3 Progressive MS Program: Continued preparations for a confirmatory Phase 3 program in progressive MS, building on the Phase 2 CALLIPER trial data. Additional Phase 2 CALLIPER Data Presented at CMSC Annual Meeting: Presented one late-breaking and two additional posters of new data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive MS at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The new analyses, which included a novel unified confirmed disability change (CDC) endpoint, up to 120 weeks of patient-reported outcomes, and safety and tolerability data, further reinforced the favorable profile of vidofludimus calcium and its potential to address underlying drivers of disability progression in progressive MS. Expansions in Management and Board of Directors: Anticipated Clinical Milestones Vidofludimus Calcium in Relapsing MS: Top-line data from the twin Phase 3 ENSURE-1 and ENSURE-2 trials remains on track and is expected to be available by the end of 2026. If positive, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. Vidofludimus Calcium in Progressive MS: The planned initiation of a Phase 3 program in progressive MS remains on track for later this year. IMU-381: The IMU-381 program, selected to leverage the Nurr1 platform for neurologic and autoimmune diseases, continues to be in preclinical testing with lead candidate identification ongoing. Financial and Operating Results Total Operating Expenses for the three and six months ended June 30, 2026 were $35.3 million and $68.6 million, respectively. Included in these results are $7.2 million and $11.7 million, respectively, of non-cash charges, primarily related to stock compensation expense. Research and Development (R&D) Expenses were $25.9 million for the three months ended June 30, 2026, as compared to $21.3 million for the three months ended June 30, 2025. The $4.6 million increase reflects (i) a $4.4 million increase in personnel expenses, $3.2 million of which was related to non-cash stock compensation, (ii) a $1.6 million increase due to drug-drug interaction studies in support of a potential NDA filing, (iii) a $1.1 million increase related to costs across numerous categories, partially offset by (iv) a $2.0 million decrease related to the CALLIPER clinical trial and (v) a $0.5 million decrease related to the ENSURE clinical trials. For the six months ended June 30, 2026, R&D expenses were $51.6 million, as compared to $42.9 million for the six months ended June 30, 2025. The $8.7 million increase reflects (i) a $5.4 million increase in personnel expenses, $3.8 million of which was related to non-cash stock compensation, (ii) a $3.9 million increase due to drug-drug interaction studies in support of a potential NDA filing, (iii) a $3.1 million increase for vidofludimus calcium drug supply and (iv) a $1.3 million increase related to costs across numerous categories, partially offset by (v) a $2.8 million decrease related to the CALLIPER clinical trial and (vi) a $2.2 million decrease related to the ENSURE clinical trials. General and Administrative (G&A) Expenses were $9.4 million for the three months ended June 30, 2026, as compared to $5.7 million for the same period ended June 30, 2025. The $3.7 million increase was due to (i) a $2.1 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation, (ii) a $0.7 million increase in legal and consultancy expenses, (iii) a $0.4 million increase in pre-commercial marketing expenses, and (iv) a $0.5 million increase in related costs across numerous categories. For the six months ended June 30, 2026, G&A expenses were $17.0 million, as compared to $11.0 million for the same period ended June 30, 2025. The $6.0 million increase was due to (i) a $4.2 million increase related to personnel expenses, of which $3.6 million was related to non-cash stock compensation, (ii) a $1.0 million increase in legal and consultancy expenses, (iii) a $0.6 million increase in pre-commercial marketing expenses, and (iv) a $0.2 million increase in related costs across numerous categories. Interest Income was $1.3 million for the three months ended June 30, 2026, as compared to $0.3 million for the three months ended June 30, 2025. The $1.0 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement. For the six months ended June 30, 2026, interest income was $2.0 million, as compared to $0.4 million for the same period ended June 30, 2025. The $1.6 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement. Other Income (Expense) was ($0.06) million for the three months ended June 30, 2026, as compared to $0.02 million for the same period ended June 30, 2025. For the six months ended June 30, 2026, Other Income (Expense) was ($0.2 million), as compared to $1.2 million for the same period ended June 30, 2025. The $1.4 million decrease was primarily attributable to (i) a $1.0 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and no grant income in 2026 and (ii) a $0.4 million decrease across various categories. Net Loss for the three months ended June 30, 2026, was approximately $34.1 million, or $0.80 per basic and diluted share, based on 42,513,839 weighted-average common shares outstanding, compared to a net loss of approximately $26.8 million, or $2.03 per basic and diluted share, based on 13,217,520 weighted-average common shares outstanding for the same period ended June 30, 2025. Net loss for the six months ended June 30, 2026, was approximately $66.7 million, or $1.83 per basic and diluted share, based on 36,359,274 weighted average common shares outstanding, compared to a net loss of approximately $52.3 million or $4.48 per basic and diluted share, based on 11,684,499 weighted average common shares outstanding for the same period ended June 30, 2025. Cash and Cash Equivalents as of June 30, 2026 were $155.1 million. With these funds, Immunic expects to be able to fund its operations into late 2027. About Immunic, Inc.Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently being evaluated in Phase 3 clinical trials for the treatment of relapsing multiple sclerosis, with top-line data expected to be available by the end of 2026. Initiation of an additional Phase 3 clinical trial in progressive MS is expected later in 2026. Vidofludimus calcium has already shown therapeutic potential and a favorable safety and tolerability profile in Phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune diseases. For further information, please visit: www.imux.com. 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 Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory Phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure 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, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc.Jessica BreuVice President Investor Relations and Communications+49 89 2080 477 [email protected] US IR ContactLifeSci AdvisorsJoyce [email protected] US Media ContactReal [email protected] Financials View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-inc-reports-second-quarter-2026-financial-results-and-provides-corporate-update-302847353.html

– Appointed Globally Renowned Biopharmaceutical Executive and Neurology Drug Developer, Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer – – Continued to Execute Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis, with Top-Line Data Expected by End of 2026 – – Raised $200 Million in an Oversubscribed Private Placement, with Potential for up to an Additional $200 Million – NEW YORK, May 13, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. "We are fast approaching a highly pivotal juncture, with the anticipated top-line data readout of the twin phase 3 ENSURE trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing multiple sclerosis (RMS), expected by the end of 2026," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "In anticipation, we strengthened our leadership team with the recent appointment of Dr. Michael A. Panzara as Chief Medical Officer. Mike brings deep expertise in neurology and a proven track record of advancing multiple sclerosis (MS) therapies through late-stage clinical development and global regulatory approvals. Additionally, we enhanced our Board of Directors with the appointment of Jon Congleton, who has nearly four decades of biopharmaceutical leadership experience. Earlier in the quarter, Simona Skerjanec, M.Pharm, M.B.A., who joined Immunic's Board of Directors in July 2024, has been elevated to interim Chairperson of the Board and Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board. Together, these key appointments are intended to best position the company for successful execution of our late-stage development priorities and prepare for potential commercialization." Dr. Vitt continued, "As important, in February, we closed an oversubscribed private placement financing of up to $400 million in gross proceeds, with $200 million received upfront. This highly successful transaction signals investors' continued confidence in Immunic and has provided the resources we need to advance our programs through key milestones and to continue our transition into a commercial-stage company. The initial proceeds are expected to fund our operations through the completion of our phase 3 ENSURE trials in RMS and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027. The funds will also support continued investment in our development organization and launch readiness. At the same time, we remain focused on expanding the opportunity for vidofludimus calcium beyond RMS, which is supported by the growing body of data from our phase 2 CALLIPER trial in progressive MS (PMS) and our plan to initiate a confirmatory phase 3 program in primary progressive MS (PPMS) later this year." Jason Tardio, President and Chief Operating Officer of Immunic, added, "We believe vidofludimus calcium has the potential to offer a transformative approach to disease modification in MS. Unlike currently available oral therapies that primarily target inflammatory pathways, vidofludimus calcium is designed to deliver both direct neuroprotective effects through Nurr1 activation and anti-inflammatory activity via selective DHODH inhibition. In clinical trials to date, vidofludimus calcium has demonstrated a favorable safety and tolerability profile. Taken together, these attributes may support a compelling benefit-risk profile in the global MS market, which is projected to exceed $30 billion by the early 2030s." First Quarter 2026 and Subsequent Highlights April 2026: Appointed accomplished biopharmaceutical executive Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer, to lead the company's development organization, including clinical development, medical affairs, and regulatory affairs. Dr. Panzara succeeds Andreas Muehler, M.D., M.B.A., who will continue to support the company as a consultant. April 2026: Effected 1-for-10 reverse stock split of the outstanding shares of common stock as of April 27, 2026. April 2026: Regained compliance with Nasdaq minimum bid price requirement (Rule 5550(a)(2)) for continued listing, following receipt of a written notice on March 27, 2026. March 2026: Appointed Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to the Board of Directors. March 2026: Announced grant of a key European patent from the European Patent Office (EPO) directed to label-relevant dosing regimens of vidofludimus calcium. The patent is expected to provide protection into 2038 and may be eligible for a Supplementary Protection Certificate (SPC), which could extend market exclusivity potentially into 2043. This patent was previously granted by the United States Patent and Trademark Office (USPTO) in 2023. February 2026: Completed an oversubscribed private placement financing of up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received upon closing on February 17, 2026. Elevated Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Appointed Thor Nagel, Principal at BVF Partners L.P., to the Board. Plans underway for further Board refreshment to support the company's evolution into a commercial-stage organization. Initiated search for a new Chief Executive Officer with deep commercial expertise in neurology to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his roots and transition to a new senior executive role focused on scientific strategy and portfolio advancement, while remaining on the Board. February 2026: Presented additional data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the ACTRIMS Forum 2026 in San Diego, California. The findings, presented in two poster presentations, provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce Immunic's belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. Subsequently, Immunic plans to submit an NDA in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. Initiation of a phase 3 clinical program in PPMS is expected later this year and is estimated to take approximately 3.5 to 4 years to complete. IMU-856: The company is currently exploring strategic alternatives for the IMU-856 program and is open to discussing potential financing, licensing or partnering options with interested parties. Financial and Operating Results Research and Development (R&D) Expenses were $25.6 million for the three months ended March 31, 2026, as compared to $21.5 million for the three months ended March 31, 2025. The $4.1 million increase reflects (i) a $2.9 million increase in external development costs related to the vidofludimus calcium program, (ii) a $1.0 million increase in personnel expenses, $0.7 million of which was related to non-cash stock compensation and (iii) a $0.2 million increase related to costs across numerous categories. General and Administrative (G&A) Expenses were $7.6 million for the three months ended March 31, 2026, as compared to $5.3 million for the same period ended March 31, 2025. The $2.3 million increase was due to (i) a $2.0 million increase related to personnel expenses, of which $1.8 million was related to non-cash stock compensation, (ii) a $0.2 million increase in legal and consultancy expenses, (iii) a $0.2 million increase in marketing expenses, which was partially offset by a $0.1 million decrease related to costs across numerous categories. Interest Income was $0.8 million for the three months ended March 31, 2026, as compared to $0.2 million for the three months ended March 31, 2025. The $0.6 million increase was due to a higher average cash balance as a result of the February 2026 Private Placement. Other Income (Expense) was ($0.1) million for the three months ended March 31, 2026, as compared to $1.2 million for the same period ended March 31, 2025. The $1.3 million decrease was primarily attributable to (i) a $1.1 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and no grant income in 2026 and (ii) a $0.2 million decrease across numerous categories. Net Loss for the three months ended March 31, 2026, was approximately $32.6 million, or $1.08 per basic and diluted share, based on 30,136,324 weighted average common shares outstanding, compared to a net loss of approximately $25.5 million, or $2.51 per basic and diluted share, based on 10,134,443 weighted average common shares outstanding for the same period ended March 31, 2025. Cash and Cash Equivalents as of March 31, 2026 were $186.6 million. With these funds, Immunic expects to be able to fund its operations into late 2027. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] Financials View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-inc-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302769899.html

– Top-Line Data from Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 – – Raised Proceeds of $200 Million in a Private Placement, with Potential for up to an Additional $200 Million – – Net Proceeds Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive Multiple Sclerosis and Begin of Transition into a Commercial Organization – NEW YORK, Feb. 26, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the year ended December 31, 2025, and provided a corporate update. "The phase 3 ENSURE-1 and ENSURE-2 trials of our lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) continue to progress, with top-line data expected to be available by the end of 2026," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "As we continue to advance our multiple sclerosis (MS) program with vidofludimus calcium, we were extremely pleased to have recently announced the successful completion of an oversubscribed private placement of up to $400 million in gross proceeds, with $200 million in upfront gross proceeds. This financing is truly a pivotal milestone for Immunic and positions us to confidently transition into a fully integrated commercial-stage company. The transaction was led by our existing investor BVF Partners L.P. with participation from a group of highly regarded new and other existing investors. This level of commitment reflects growing confidence in our program and reinforces our belief in vidofludimus calcium's potential to address the underlying drivers of MS progression." "The proceeds from the initial closing are expected to fund our operations through the ENSURE top-line data and our planned RMS New Drug Application (NDA) submission in the United States in mid-2027, with a targeted potential regulatory approval date in 2028," continued Dr. Vitt. "They also support preparations for the potential launch of vidofludimus calcium in RMS, including expansion of our medical and commercial infrastructure. Additionally, based on the totality of the phase 2 CALLIPER trial data in progressive MS, which showed not only substantial and medically relevant reductions for vidofludimus calcium in delaying 24-week confirmed disability progression but also statistically significant 24-week confirmed disability improvement, while confirming the drug's favorable safety and tolerability profile already observed in previous clinical trials, we plan to initiate a confirmatory phase 3 program in primary progressive multiple sclerosis (PPMS) later this year as well." Jason Tardio, President and Chief Operating Officer of Immunic, added, "This is an exciting moment for Immunic and for individuals living with MS, as we believe that vidofludimus calcium could represent a potentially transformative approach to disease modification. Current oral therapies for RMS mainly control inflammation and relapses, often have complex safety and tolerability issues and do not adequately address the neurodegenerative processes driving disability progression and long-term disability. In contrast, vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through Nurr1 activation, while reducing new inflammatory damage via selective DHODH inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses. As such, we believe vidofludimus calcium may achieve a best-in-class benefit-risk profile and, therefore, could represent a large commercial opportunity in the global MS market, which is projected to reach over $30 billion by the early 2030s." Fourth Quarter 2025 and Subsequent Highlights February 2026: Completed an oversubscribed private placement of up to $400 million in gross proceeds, led by existing investor BVF Partners L.P. with participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors. A total of $200 million in gross proceeds to Immunic was received upon closing on February 17, 2026. Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, elevated to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, remains a member of the Board. Thor Nagel, Principal at BVF Partners L.P., appointed to the Board. Plans underway for further Board refreshment to support the company's evolution into a commercial-stage organization. Initiated search for a new Chief Executive Officer with deep commercial expertise in MS to lead Immunic into its next stage of growth and commercialization. Subsequently, Dr. Vitt will return to his roots and transition to a new senior executive role focused on scientific strategy and portfolio advancement, while remaining on the Board. February 2026: Presented additional data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive MS at the ACTRIMS Forum 2026. The findings, presented in two poster presentations, provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce Immunic's belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. Subsequently, Immunic plans to submit an NDA in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. Initiation of a phase 3 clinical program in PPMS is expected later this year and estimated to take approximately 3.5 to 4 years to complete. IMU-856: The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering. Financial and Operating Results Research and Development (R&D) Expenses were $82.0 million for the twelve months ended December 31, 2025, as compared to $80.0 million for the twelve months ended December 31, 2024. The $1.9 million increase reflects (i) a $3.9 million increase in external development costs related to the vidofludimus calcium program and (ii) a $1.8 million increase in personnel expenses for R&D. The increase was offset by (i) a $3.0 million decrease in external development costs related to IMU-856 and (ii) a $0.8 million decrease across numerous categories. General and Administrative (G&A) Expenses were $21.2 million for the twelve months ended December 31, 2025, as compared to $18.0 million for the same period ended December 31, 2024. The $3.2 million increase was due to (i) a $1.9 million increase related to personnel expenses, of which $0.3 million was related to non-cash stock compensation, (ii) a $0.8 million increase in legal and consultancy expenses and (iii) a $0.5 million increase related to costs across numerous categories. Interest Income was $1.0 million for the twelve months ended December 31, 2025, as compared to $3.4 million for the twelve months ended December 31, 2024. The $2.4 million decrease was due to a lower average cash balance. In the twelve months ended December 31, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the company's authorized shares from 130 million to 500 million shares of common stock and, therefore, the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the twelve months ended December 31, 2025. Other Income (Expense) was $5.0 million for the twelve months ended December 31, 2025, as compared to ($1.0 million) for the same period ended December 31, 2024. The $6.1 million increase was primarily attributable to (i) $4.8 million of grant income from the German Federal Ministry of Finance, of which $1.0 million was recognized in the first quarter 2025 and $3.8 million was recognized in the fourth quarter 2025, (ii) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia. Net Loss for the twelve months ended December 31, 2025, was approximately $97.2 million, or $0.62 per basic and diluted share, based on 155,688,030 weighted average common shares outstanding, compared to a net loss of approximately $100.5 million, or $1.00 per basic and diluted share, based on 100,174,766 weighted average common shares outstanding for the same period ended December 31, 2024. Cash and Cash Equivalents as of December 31, 2025 were approximately $15.5 million. With these funds and the approximately $187.0 million net cash proceeds raised in the February 2026 private placement, Immunic expects to be able to fund its operations into late 2027. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases such as celiac disease, inflammatory bowel disease, and Graft-versus-Host-Disease. IMU-381 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging the company's Nurr1 platform. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] Financials View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-inc-reports-year-end-2025-financial-results-and-provides-corporate-update-302697386.html

– Key Data Highlighting Vidofludimus Calcium's Therapeutic Potential in Multiple Sclerosis Presented at 41st Congress of ECTRIMS – – Phase 2 CALLIPER Data Demonstrated Statistically Significant 24-Week Confirmed Disability Improvement in Progressive Multiple Sclerosis, With Consistent Signals for Slowing Disability Progression Across Subgroups and Endpoints, Supporting Vidofludimus Calcium's Neuroprotective Potential and Nurr1 Activation Mechanism – – Long-Term Phase 2 EMPhASIS Data in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of Confirmed Disability Worsening and Favorable Long-Term Safety and Tolerability – – Top-Line Data from Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 – NEW YORK, Nov. 13, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the three and nine months ended September 30, 2025, and provided a corporate update. "The third quarter was marked by our strong presence at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), during which we had the opportunity to highlight the clinical momentum of our lead asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor-related 1 (Nurr1) activator, and its potential to transform the oral multiple sclerosis (MS) therapy landscape," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The collective data meanwhile available from across our clinical MS trials, including the phase 2 CALLIPER and EMPhASIS trials, highlight vidofludimus calcium's unique promise to slow disability progression in both relapsing and progressive forms of the disease. Notably, new data from our positive phase 2 CALLIPER trial in progressive MS (PMS), also featured in the Best of ECTRIMS 2025 slide deck, showed statistically significant 24-week confirmed disability improvement in the overall patient population and consistent effects across both the primary progressive MS (PPMS) and non-active secondary progressive MS (naSPMS) subgroups, further reinforcing the compound's neuroprotective and anti-inflammatory characteristics." "We believe the CALLIPER data clearly support advancing vidofludimus calcium into phase 3 development in progressive forms of MS. With only one approved therapy currently available for PPMS, there is a significant opportunity in this underserved, multi-billion-dollar market. By slowing disease progression, vidofludimus calcium could help patients maintain independence, manage symptoms more effectively, and achieve improved long-term outcomes." Dr. Vitt continued, "Notably, we also presented additional long-term data from the open-label extension (OLE) period of our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) at ECTRIMS, which further highlighted the robust efficacy signals and favorable safety and tolerability observed, to date. Our twin phase 3 ENSURE trials in relapsing MS (RMS) remain on track. Given vidofludimus calcium's unique profile and its potential to become the oral therapy of choice addressing the full spectrum of MS, we look forward to reporting top-line data by the end of 2026." "We also successfully continued our efforts to meaningfully enhance our strong and multi-layered intellectual property position for vidofludimus calcium. During the quarter, we received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering dose strengths of vidofludimus calcium for the treatment of PMS. This newly allowed patent adds another layer of potential exclusivity protection in the United States, with the option for further term extension." Third Quarter 2025 Highlights September 2025: Presented key data at the 41st Congress of ECTRIMS, highlighting vidofludimus calcium's therapeutic potential in MS, in one oral and four poster presentations, including one late-breaking poster. The results from the phase 2 CALLIPER trial in PMS were also selected for the Best of ECTRIMS 2025 slide deck. The CALLIPER data underscored vidofludimus calcium's neuroprotective potential across PMS populations and its ability to slow disease progression in patients with or without focal inflammation. Consistent 24-week confirmed disability worsening (24wCDW) outcomes were observed across disability endpoints, patient populations and subgroups (including the overall population and in PPMS and naSPMS), and those without baseline inflammatory gadolinium-enhancing (Gd+) lesions during magnetic resonance imaging (MRI). Newly available data regarding 24-week confirmed disability improvement (24wCDI) demonstrated a greater than two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across subtypes. These findings support clinically measurable neuroprotective effects consistent with vidofludimus calcium's Nurr1 activation mechanism and de-risk a potential phase 3 program, as 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS. Long-term data from the phase 2 EMPhASIS OLE period reinforced vidofludimus calcium's robust efficacy signals and favorable safety and tolerability profile, demonstrating that it was well-tolerated for treatment durations of up to 5.5 years in patients with RRMS. Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled ~952 treatment years with an annualized discontinuation rate of only ~6.4%. Most adverse events were mild, with low rates of renal and liver-related events, and no new safety signals observed. Serious adverse events were infrequent, and none were deemed related to treatment. September 2025: Received a Notice of Allowance from the USPTO for patent application 18/529,946, entitled, "Treatment of multiple sclerosis comprising DHODH inhibitors." The resulting patent covers dose strengths associated with vidofludimus calcium and other salt forms as well as free acid forms, at a daily dose of about 10 mg to 45 mg, for the treatment of PMS, including the sub-groups PPMS and secondary progressive multiple sclerosis (SPMS). The patent is expected to provide protection into 2041, and potential Patent Term Extension may offer additional market exclusivity in the United States. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials in RMS is expected by the end of 2026. IMU-856: The company is preparing for further clinical testing of IMU-856, the orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), contingent on financing, licensing or partnering. Financial and Operating Results Research and Development (R&D) Expenses were $20.0 million for the three months ended September 30, 2025, as compared to $21.4 million for the three months ended September 30, 2024. The $1.4 million decrease reflects (i) a $1.3 million decrease in external development costs related to IMU-856, (ii) a $1.1 million decrease in external development costs related to the completion of the phase 2 CALLIPER trial in the prior year and (iii) a $0.2 million decrease related to costs across numerous categories. The decrease was offset by a $1.2 million increase in personnel expenses for R&D, of which $0.8 million were related to non-cash shared-based compensation. For the nine months ended September 30, 2025, R&D expenses were $63.0 million, as compared to $58.4 million for the nine months ended September 30, 2024. The $4.5 million increase reflects (i) a $6.2 million increase in external development costs related to the phase 3 ENSURE trials and (ii) a $1.6 million increase in personnel expenses for R&D, of which $0.4 million was related to non-cash stock compensation. The increase was offset by (i) a $2.7 million decrease in external development costs related to IMU-856 primarily due to the timing of the purchase of drug supply for this program and (ii) a $0.6 million decrease across numerous categories. General and Administrative (G&A) Expenses were $6.0 million for the three months ended September 30, 2025, as compared to $4.4 million for the same period ended September 30, 2024. The $1.6 million increase was due to (i) a $1.2 million increase in personnel expenses, of which $1.0 million is related to non-cash share-based compensation and (ii) a $0.4 million increase related to costs across numerous categories. For the nine months ended September 30, 2025, G&A expenses were $17.0 million, as compared to $14.0 million for the same period ended September 30, 2024. The $3.0 million increase was due to (i) a $1.8 million increase related to personnel expenses, of which $0.8 million was related to non-cash stock compensation, (ii) a $0.6 million increase in legal and consultancy expenses and (iii) a $0.6 million increase related to costs across numerous categories. Interest Income was $0.4 million for the three months ended September 30, 2025, as compared to $0.8 million for the three months ended September 30, 2024. The $0.4 million decrease was primarily due to a lower average cash balance. For the nine months ended September 30, 2025, interest income was $0.8 million, as compared to $3.0 million for the same period ended September 30, 2024. The $2.1 million decrease was due to a lower average cash balance. In the nine months ended September 30, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in the authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the nine months ended September 30, 2025. Other Income (Expense) was negligible for the three months ended September 30, 2025, as compared to $0.6 million for the same period ended September 30, 2024. The $0.6 million decrease was primarily attributable to a decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia. For the nine months ended September 30, 2025, Other Income (Expense) was $1.2 million, as compared to ($1.1 million) for the same period ending September 30, 2024. The $2.3 million increase was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024, (ii) $1.0 million of grant income from the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia. Net Loss for the three months ended September 30, 2025, was approximately $25.6 million, or $0.13 per basic and diluted share, based on 193,897,764 weighted average common shares outstanding, compared to a net loss of approximately $24.4 million, or $0.24 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding for the same period ended September 30, 2024. Net loss for the nine months ended September 30, 2025, was approximately $77.9 million, or $0.55 per basic and diluted share, based on 142,811,489 weighted average common shares outstanding, compared to a net loss of approximately $75.3 million or $0.75 per basic and diluted share, based on 99,998,245 weighted average common shares outstanding for the same period ended September 30, 2024. Cash and Cash Equivalents as of September 30, 2025 were $35.1 million. With this cash, the company does not have adequate liquidity to fund its operations for at least 12 months from September 30, 2025, without raising additional capital. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] Financials View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-inc-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302614351.html

– Vidofludimus Calcium Substantially Reduced 24-Week Confirmed Disability Worsening in Phase 2 CALLIPER Trial in Overall Progressive Multiple Sclerosis Study Population and Across Subtypes, Reinforcing the Drug's Neuroprotective Potential and Ability to Slow Disease Progression – – Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 – – New Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of 12-Week and 24-Week Confirmed Disability Worsening – – Strengthened Balance Sheet with Two Financings Totaling $70.1 Million in Gross Proceeds – NEW YORK, Aug. 7, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the second quarter and six months ended June 30, 2025, and provided a corporate update. "During the second quarter and more recently, we have made substantial clinical progress in advancing our potentially transformative lead asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor-related 1 (Nurr1) activator," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Most notable was the on-time completion of enrollment of our twin phase 3 ENSURE trials, bringing us one step closer to delivering a novel treatment option for people living with relapsing multiple sclerosis (RMS). The unique neuroprotective effects observed to date also support the phase 3 ENSURE trials, where confirmed disability worsening will be analyzed. Top-line data from both trials, expected by the end of 2026, will allow for a synchronized readout and a pooled analysis of this clinical endpoint. The growing body of evidence we have amassed continues to strengthen our confidence that, if approved, vidofludimus calcium, with a distinct combination of neuroprotective, anti-inflammatory and anti-viral properties observed, as well as a well-established safety and tolerability profile, has the potential to emerge as a differentiated oral therapy that addresses the complex pathophysiology of multiple sclerosis (MS)." "We also reported strong results from our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), showing a 23.8% reduction in time to 24-week confirmed disability worsening (24wCDW) in the overall study population compared to placebo. In the high unmet need subgroup of primary progressive MS (PPMS), this effect was 31.3%, exceeding outcomes observed in previous PPMS trials. In another high unmet need subtype, non-active SPMS (naSPMS), the reduction was 19.2%. Moreover, patients without gadolinium-enhancing lesions at baseline, who often do not benefit from existing treatments, saw 24wCDW reductions of 33.7% for the overall PMS population, as well as 34.4% and 29.8% for the PPMS and naSPMS subgroups, respectively. Since time to 24wCDW is a recognized regulatory endpoint for assessing clinical benefit in PMS, we believe these findings strongly support advancing vidofludimus calcium into phase 3 development in progressive forms of MS. With only one approved treatment currently available for PPMS, vidofludimus calcium may be a highly promising option for this underserved $6+ billion market, where reduction of disease progression would allow patients to remain more independent, manage symptoms more easily and achieve better long-term outcomes." Management noted that, among the continued stream of positive data for vidofludimus calcium was the new readout from the long-term open-label extension (OLE) phase of the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS), which further reinforced the strong efficacy signals previously observed in this trial. Data showed that at week 144, 92.3% of patients remained free of 12-week confirmed disability worsening (12wCDW), and 92.7% were free of 24wCDW. This, and previously announced results across the MS program—including the top-line EMPhASIS and CALLIPER data—further support the potential of vidofludimus calcium to slow disease progression. These findings also continue to highlight its neuroprotective effects, which are believed to be mediated through activation of the Nurr1 target. Based on the strength of the data, a total of five abstracts have been selected for presentation at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September, including one oral presentation and one late-breaking poster – a major achievement for the company. Dr. Vitt added, "Beyond vidofludimus calcium, compelling clinical and preclinical data for IMU-856, our orally available and systemically acting small molecule modulator that targets sirtuin 6 (SIRT6), indicates the drug's strong promise as a potential novel therapeutic for gastrointestinal disorders. Based on encouraging data available to date, we are preparing for further clinical testing while exploring potential financing, licensing, or partnership opportunities to advance the program. Additionally, IMU-856 has shown potential as an oral treatment option for weight management. More specifically, a post hoc analysis of our phase 1b clinical trial results showed up to a 250% increase in GLP-1 levels versus placebo in fasting celiac disease patients, mimicking natural post-meal responses and suggesting that IMU-856 may activate enteroendocrine pathways physiologically, offering a broader mechanism than current injectable incretin mimetics. If validated in future trials, this once-daily oral small molecule could become a convenient treatment alternative for weight management." Second Quarter 2025 and Subsequent Highlights April 2025: Announced positive data from the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. The results demonstrated reduced relative risks of 24wCDW events in the overall study population as well as PMS subtypes compared to placebo. Notably, the drug showed a consistent reduction of disability worsening in subpopulations without inflammatory lesions at baseline and reduced 24wCDW in patients without gadolinium-enhancing lesions at baseline. Vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss and the volume of new/enlarging T2 lesions compared to placebo. No new safety signals were identified, confirming the favorable safety and tolerability profile already observed in previous clinical trials. April 2025: Announced a $5.1 million registered direct offering led by Aberdeen Investments. May 2025: Announced an oversubscribed $65 million underwritten public offering. 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. June 2025: Announced additional data underlining the positive outcome of the phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. The data for the secondary endpoint of time to 24wCDW, based on the Expanded Disability Status Scale (EDSS), further reinforced the neuroprotective potential of vidofludimus calcium. Similarly, consistent with the top-line data, further analyses of subpopulations – both with and without inflammatory gadolinium-enhanced lesion activity at baseline – continued to demonstrate promising results. June 2025: Announced the on-time completion of enrollment for both phase 3 ENSURE trials of vidofludimus calcium in patients with RMS. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized at more than 100 sites in 15 countries. June 2025: Reported new, long-term OLE data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS. At week 144, 92.3% of patients remained free of 12wCDW and 92.7% remaining free of 24wCDW. Vidofludimus calcium continued to demonstrate a favorable safety and tolerability profile with long-term data available up to 5.5 years. Anticipated Clinical Milestones Vidofludimus calcium in MS: Top-line data from the twin phase 3 ENSURE-1 and ENSURE-2 trials is expected by the end of 2026. IMU-856: The company is preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering. Financial and Operating Results Research and Development (R&D) Expenses were $21.4 million for the three months ended June 30, 2025, as compared to $18.3 million for the three months ended June 30, 2024. The $3.0 million increase reflects (i) a $2.6 million increase in external development costs related to the vidofludimus calcium programs and (ii) a $0.6 million increase in personnel expenses. The increase was offset by a $0.2 million decrease related costs across numerous categories. For the six months ended June 30, 2025, R&D expenses were $42.9 million, as compared to $37.1 million for the six months ended June 30, 2024. The $5.8 million increase reflects a $7.3 million increase in external development costs related to the vidofludimus calcium programs. The increase was offset by a $1.5 million decrease in external development costs related to IMU-856 due to the completion of the phase 1b clinical trial in celiac disease patients in 2024. General and Administrative (G&A) Expenses were $5.7 million for the three months ended June 30, 2025, as compared to $4.5 million for the same period ended June 30, 2024. The $1.2 million increase was due to (i) a $0.8 million increase in personnel expenses and (ii) a $0.4 million increase in legal and consultancy expenses. For the six months ended June 30, 2025, G&A expenses were $11.0 million, as compared to $9.6 million for the same period ended June 30, 2024. The $1.4 million increase was due to (i) a $0.7 million increase related to personnel expenses, (ii) a $0.5 million increase in legal and consultancy expenses and (iii) a $0.2 million increase related costs across numerous categories. Interest Income was $0.2 million for the three months ended June 30, 2025, as compared to $1.0 million for the three months ended June 30, 2024. The $0.8 million decrease was due to a lower average cash balance. For the six months ended June 30, 2025, interest income was $0.4 million, as compared to $2.2 million for the same period ended June 30, 2024. The $1.8 million decrease was due to a lower average cash balance. The Change in Fair Value of the Tranche Rights of $4.8 million in the six months ended June 30, 2024, was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability because the company did not have a sufficient number of authorized shares to issue in tranche 2 and tranche 3 of the offering. But these tranche rights were reclassified to equity on March 4, 2024, when stockholders approved the increase in authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclass to equity. There was no change in fair value of the tranche rights recognized in the six months ended June 30, 2025. Other Income (Expense) was $0.02 million for the three months ended June 30, 2025, as compared to $0.4 million for the same period ended June 30, 2024. The $0.4 million decrease was primarily attributable to activity across numerous categories. For the six months ended June 30, 2025, Other Income (Expense) was $1.2 million, as compared to ($1.7 million) for the same period ending June 30, 2024. The $2.8 million increase was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024, (ii) a $1.0 million grant income of the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.1 million increase across numerous categories. Net Loss for the three months ended June 30, 2025, was approximately $27.0 million, or $0.20 per basic and diluted share, based on 132,175,202 weighted average common shares outstanding, compared to a net loss of approximately $21.4 million, or $0.21 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding for the same period ended June 30, 2024. Net loss for the six months ended June 30, 2025, was approximately $52.3 million, or $0.45 per basic and diluted share, based on 116,844,985 weighted average common shares outstanding, compared to a net loss of approximately $51.0 million or $0.51 per basic and diluted share, based on 99,607,158 weighted average common shares outstanding for the same period ended June 30, 2024. Cash and Cash Equivalents as of June 30, 2025 were $55.3 million. With this cash, the company does not have adequate liquidity to fund its operations for at least twelve months from June 30, 2025, without raising additional capital. 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: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] Financials View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-inc-reports-second-quarter-2025-financial-results-and-provides-corporate-update-302523491.html SOURCE Immunic, Inc.