Ocrelizumab

– Proven Leader with Deep Multiple Sclerosis Expertise; Played Key Role in the Launch of Ocrevus® – – Will Leverage Senior Global Executive and Commercial Experience to Support Immunic's Transition Toward a Commercial-Stage Multiple Sclerosis Company – NEW YORK, May 27, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of distinguished biopharmaceutical executive Erik Lundgren as Chief Executive Officer, effective May 22, 2026, with employment beginning on June 1, 2026. Mr. Lundgren succeeds Daniel Vitt, Ph.D., who will retain responsibility for scientific strategy and portfolio advancement while remaining a member of Immunic's Board of Directors. Mr. Lundgren will lead Immunic as the company advances vidofludimus calcium through late-stage clinical development, including the pivotal phase 3 ENSURE program in relapsing multiple sclerosis (RMS) and the planned phase 3 program in primary progressive multiple sclerosis (PPMS), while also preparing for potential new drug application (NDA) filing, regulatory approval and commercialization. "Immunic has evolved into a global late-stage biotechnology company built around its lead asset, vidofludimus calcium, which we believe represents one of the most compelling and differentiated opportunities in multiple sclerosis (MS) today," stated Michael W. Bonney, Chair of Immunic's Board of Directors. "As we look to our next phase of growth, including the pivotal phase 3 RMS data readout expected by year-end, preparations for NDA filing in this indication and potential commercialization thereafter, Erik's experience will be invaluable. I look forward to working with him as we continue transitioning Immunic toward a commercial-stage neurology company and deliver a potential next-generation treatment option for people living with MS." "I am truly honored to be joining Immunic at such an exciting and pivotal moment," stated Mr. Lundgren. "Over the past decade, the treatment landscape for MS has advanced meaningfully, broadening what is possible for people living with this complex disease. Yet a large unmet need remains, particularly for treatment options with the potential to slow disability progression and preserve neurological function. Vidofludimus calcium's potential to treat MS by targeting both immunological and neuroprotective pathways, along with a safety and tolerability profile that appears favorable to date, offers a differentiated approach within the MS therapeutic landscape, with the chance to impact both relapsing and progressive forms of the disease. Having spent my career focused on bringing innovative medicines to patients, including those with MS, I believe Immunic is uniquely positioned to advance this important program through late-stage development and potential commercialization. I look forward to working alongside the talented team at Immunic to help realize that vision." "Erik is highly accomplished and possesses the strategic, operational and commercial know-how needed to steer Immunic at this critical juncture," added Dr. Vitt. "His deep expertise in MS, including his role in helping shape the launch of Ocrevus®, combined with his long tenure and broad experience across Genentech and Roche, will be instrumental as we advance vidofludimus calcium through the pivotal phase 3 ENSURE readout in RMS and continue preparations for our planned phase 3 program in PPMS. As we approach these important milestones and continue our evolution toward becoming a commercial-stage biotechnology company, I am convinced that Erik is the right leader to guide Immunic into its next chapter. I look forward to continuing to support the company's scientific strategy and working alongside Erik and the Board to realize the full potential of our pipeline." Mr. Lundgren brings nearly two decades of biopharmaceutical experience spanning commercial strategy, product launches, global portfolio leadership, marketing and general management, with particular expertise in MS. He most recently served as Senior Vice President, Commercial Portfolio Organization at Genentech (a member of the Roche Group), where he led and oversaw the commercial strategy across all therapeutic areas of the company's broad portfolio. Prior to this role, he served as General Manager of Roche Czech Republic, where he led full operations and commercial strategy. Earlier, he served as Lifecycle Leader for Huntington's disease within Roche's neuroscience portfolio. Mr. Lundgren spent more than a decade at Genentech in roles of increasing responsibility, including serving as Senior Marketing Director supporting the launch and commercialization of Ocrevus® (ocrelizumab), a foundational treatment for RMS and PPMS and one of the most successful launches in neurology. He also held commercial leadership roles supporting the launches of oncology medicines, including Kadcyla® (ado-trastuzumab emtansine) and Zelboraf® (vemurafenib), and led various sales teams within Genentech's oncology franchise. Mr. Lundgren earned his Bachelor of Arts in Public Policy from Duke University and his Master of Business Administration from Harvard Business School. The Compensation Committee of Immunic's Board of Directors granted Mr. Lundgren an initial equity option to purchase 1,000,000 shares of common stock of the company under the Immunic, Inc. 2026 Inducement Equity Compensation Plan (the "Options"). The Options were granted as an inducement material to Mr. Lundgren's commencement of employment pursuant to NASDAQ Listing Rule 5635(c)(4). The Options will be time vested, with 25% vesting on the one-year anniversary of May 22, 2026 and the remainder vesting on a monthly basis in 36 equal installments. 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: . 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 expectations regarding 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 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; the executive and board structure of the company; and the appointment of Mr. Lundgren and his integration into 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 macroeconomic 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 or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo

> 在阿尔茨海默病药物临床试验失败率高达99.6%的“研发荒漠”里，罗氏不仅没撤退，反而用近一个世纪的坚守，把神经科学做成了年入**98亿瑞士法郎**、同比增长11%的赚钱生意。 当外界还在讨论神经疾病是未来故事时，罗氏已经在中国市场，用一套“以价换量”加“管线押注”的组合拳，将蓝图变成了真金白银的营收报表。 ## 营收拆解：现金牛与增长极并存 罗氏神经科学的钱，首先来自两款已上市的“现金牛”产品。**奥瑞利珠单抗（罗可适®）**，作为多发性硬化药物，凭借每年仅需两次皮下注射的便捷性，在2025年创造了**84.74亿美元**的全球销售额，是公司最稳定的收入基石之一。 另一款**利司扑兰（艾满欣®）**，作为全球首款口服脊髓性肌萎缩症（SMA）药物，打破了注射给药的局限，同年销售额也达到**21.24亿美元**。 在中国市场，这两款核心产品均已通过国家医保谈判准入，策略意图明确：**以价格让步换取患者基数扩张**。例如，利司扑兰进入医保后，患者年治疗费用从过去的数十万元级别降至数万元级别，大幅提升了药物可及性。 这种“以价换量”的模式，虽然可能压低单品利润率，但通过纳入国家医保目录，迅速打开了庞大的患者市场，为持续营收提供了保障。 ## 中国策略：全链条布局的“以价换量”逻辑 罗氏在中国市场的商业逻辑，远不止“卖药”这么简单。其核心是构建“研发-临床-准入-服务”的全链条，最终服务于市场规模的最大化。 - **研发与申报前置**：罗氏将中国定位为全球核心市场，推动**Trontinemab**（阿尔茨海默病）、**Prasinezumab**（帕金森病）等重磅在研药物在中国同步开展临床试验，旨在缩短全球创新药在中国的上市时差。 - **支付端打通**：推动创新药进入医保是其商业化的关键一环。目前，萨特利珠单抗、利司扑兰等多款神经药物已纳入国家医保目录，这直接决定了产品能否快速放量。 - **服务链延伸**：针对帕金森病等需终身用药的慢病，罗氏支持构建“上下联动”的诊疗体系，打通大医院确诊与基层医院续方渠道，并探索利用AI工具进行患者长期管理。这一方面提升了患者依从性，确保了长期用药需求；另一方面也深化了与医疗机构的合作，稳固了市场渠道。 ## 生产短板：战略愿景与当前现实的差距 然而，在关乎成本与供应稳定的生产环节，罗氏的本地化布局仍停留在战略声明阶段。公开信息显示，**目前罗氏在中国尚未有神经科学药物的专属生产基地投产**。其位于苏州的现有基地主要生产诊断试剂，而非治疗性药物。 尽管公司管理层表示将“持续推进创新药本土化生产以降低成本、保障供应”，但具体时间表和规划细节缺失。这意味着，当前核心神经药物的供应链可能仍依赖于全球网络，在面临地缘政治或物流风险时，其成本控制和供应稳定性存在潜在挑战。 生产本地化的滞后，是其中国商业拼图中一块尚未补齐的短板。 ## 未来赌注：押注下一个百亿美金管线 当前收入靠已上市产品支撑，而罗氏未来的增长则押注在三条高风险的管线上。这些药物瞄准的正是神经领域最棘手、但也可能带来最大回报的疾病。 - **Trontinemab（阿尔茨海默病）**：采用独有的Brainshuttle™脑穿梭技术，号称能将药物入脑效率提升数十倍。Ib/IIa期数据显示，91%的患者在7个月内脑内淀粉样蛋白转为阴性，而相关水肿或出血风险低于5%。 如果后续III期临床试验成功，它有望在2030年前后上市，冲击规模巨大的阿尔茨海默病市场。 - **Prasinezumab（帕金森病）**：作为全球首创的疾病修饰疗法，靶向α-突触核蛋白，目标直指延缓疾病进展，而不仅仅是缓解症状。 - **Fenebrutinib（多发性硬化）**：一款可穿透血脑屏障的口服BTK抑制剂，III期数据显示能将患者年化复发率降低**50%以上**，目前已进入中国上市申请阶段。 这些管线是典型的“高风险、高回报”投资。一旦成功，任何一款都可能成为新的十亿甚至百亿美元级别的重磅产品；但神经药物研发的高失败率，也意味着巨额投入可能血本无归。 ## 结论：用确定性收入，赌不确定性未来 罗氏在中国神经科学的商业模型清晰可辨：**利用已上市“现金牛”产品通过医保谈判实现快速市场渗透和现金流回收，同时将赚取的利润持续投入高风险、高潜力的在研管线，以赌下一个时代的增长**。 其护城河在于近一个世纪积累的疾病认知、差异化的给药技术（如口服、长效注射），以及“制药+诊断”的生态协同能力。 但模型的风险同样明确：明星在研管线存在临床失败风险；生产本地化滞后可能在未来影响成本优势与供应链安全；同时，在SMA等领域，它正面临来自诺华、渤健等对手的激烈竞争。 罗氏的故事，是一个用长期主义的耐心和当期确定的收入，去博弈一个充满不确定性但极具诱惑力的未来的经典商业案例。