Respiratory Syncytial Virus Vaccine(Moderna)

Provides broad overview of Company's research and early development programs expected to continue to fuel future growth Highlights validation of T-cell engager modality with mRNA-2808 in multiple myeloma, supporting rapid advancement of second T-cell engager mRNA-2151 in ovarian cancer Introduces in vivo CAR-T modality with mRNA-6007 moving into early development for autoimmune diseases CAMBRIDGE, MA / ACCESS Newswire / June 25, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced research and early development updates at its Science Day event. "As we execute our strategic plan to become a diversified, multi-modality biotechnology company, we are preparing to manage three commercial franchises, Infectious Disease Vaccines, Intismeran, and Rare Disease Therapeutics, while advancing a broad mRNA pipeline and continuing to invest in research and development," said Stéphane Bancel, CEO of Moderna. "Working across three strategic horizons, we are applying our mRNA platform expertise to validate, scale and expand our modalities, with new modalities in the clinic, including T-cell engagers, and new modalities soon to be in the clinic, like in vivo CAR-T. At the same time, we are driving innovation by using data, AI and machine learning, and robotics to accelerate discovery and continuously improve how we execute for near-term growth while fueling the next generation of mRNA medicines for patients around the world. We are fortunate to have the privilege to make medicine at this moment in time." Moderna is executing a strategy that balances near-term growth with long-term innovation. Building on the momentum of its four approved products -- Spikevax ® , mRESVIA ® , mNEXSPIKE ® and mCOMBRIAX ® -- the Company is driving growth through infectious disease launches, geographic expansion, and the advancement of late-stage pipeline opportunities, including its investigational intismeran autogene therapy and propionic acidemia therapeutic. In parallel, Moderna Research and Early Development, mRED, is focused on emerging and future modalities to advance high-potential programs toward clinical proof-of-concept and first-in-human milestones. Moderna's Scientific Intelligence Engine is harnessing data, AI and machine learning, automation, and robotics to accelerate discovery and continuously improve how the Company operates. Platform Strategy Moderna's platform is built on three integrated pillars: mRNA science, delivery science and manufacturing processes. By combining the components of its mRNA platform, the Company creates modalities, or groups of potential mRNA medicines that share similar mRNA technologies, delivery technologies, and manufacturing processes to achieve shared product features. These modalities turn platform expertise into repeatable development by generating proof-of-concept data from sentinel programs to de-risk modalities and accelerate development plans. Moderna has established and scaled multiple modalities, including infectious disease vaccines, intismeran autogene, and rare disease therapeutics, to validate its platform and considers these its Horizon 1 established modalities. Horizon 1 comprises Moderna's late-stage and approved products, while continuing to enable innovation in these established modalities, and drives an end-to-end path from discovery through commercialization. Moderna Research and Early Development Moderna Research and Early Development (mRED) builds Moderna's next growth horizons by advancing differentiated, platform-enabled modalities. Horizon 2 emerging modalities and Horizon 3 future modalities are led by mRED to scale and expand the Company's mRNA platform. Horizon 2 modalities are in the clinic and awaiting human proof-of-concept. The majority are in Phase 1/2 studies in oncology, with a multiple sclerosis therapeutic in Phase 2. Horizon 3 modalities have the potential to advance to first-in-human clinical trials by the end of 2027. Scientific Intelligence Engine Data from across Moderna's three Horizons powers an AI-enabled engine for accelerated discovery. This includes data generated by the Company's mRNA platform as well as internal proprietary and publicly available data. The engine feeds a continuous learning loop that helps de-risk program development through mRNA platform innovation. Early Pipeline Progress Highlights from Moderna's early-stage pipeline include: Horizon 2 mRNA-4106 (Cancer antigen therapy): Encodes shared nonmutated cancer testes antigens designed to elicit T-cell immune responses against tumor cells. The Phase 1 study is ongoing with mRNA-4106 as monotherapy in advanced solid tumors. mRNA-4200 (Cancer antigen therapy): Encodes shared nonmutated tumor associated antigens designed to elicit T-cell immune responses against tumors. The Phase 1 study is planned in combination with pembrolizumab in advanced solid tumors. mRNA-4194 (Cancer antigen therapy): Encodes frameshift peptides frequently identified in Lynch syndrome, an inherited condition that increases cancer risk. The Phase 1/2 study is planned to start in Lynch syndrome this summer with the goal of preventing progression of pre-malignancies to cancer. mRNA-4194 represents Moderna's first investigational cancer prevention program. mRNA-4359 (Cancer antigen therapy): Designed to elicit T-cell immune responses against tumor and immunosuppressive cells, the Phase 1/2 study is ongoing with the Phase 2 portion including cohorts in first-line metastatic melanoma and first-line metastatic non-small cell lung cancer (NSCLC). mRNA-2808 (T-cell engager): Designed to use multiplexed T-cell engagers to improve efficacy and overcome mechanisms of resistance for multiple myeloma, the Phase 1/2 study is ongoing and includes three distinct T-cell engagers against clinically validated targets. mRNA-2151 (T-cell engager): Designed to improve anti-tumor efficacy in solid tumors, this preclinical multiplexed T-cell engager program is moving toward early development in ovarian cancer. Advancement of mRNA-2151 is supported by an encouraging early clinical signal with mRNA-2808. mRNA-1195 (Multiple sclerosis therapeutic): Designed to address Epstein-Barr virus (EBV)-associated conditions including multiple sclerosis, the Phase 1 part B data is expected in the second half of 2026. The Phase 2 study in multiple sclerosis is ongoing; with its sentinel cohort fully enrolled, the DSMB has recommended to proceed with dose escalation. Horizon 3 mRNA-6007 (In vivo CAR-T): Designed to enable deep B-cell depletion for autoimmune conditions using a multiplexed mRNA approach with targeted lipid nanoparticles, the program aims to deliver mRNA into immune cells in vivo, enabling transient CAR expression and potential immune reset. The initial clinical focus is systemic lupus erythematosus (SLE) and other B cell mediated autoimmune diseases. For more details on the data and programmatic updates shared during Moderna's Science Day investor event today, please visit "Events and Presentations" in the Investors section of the Moderna website. About Moderna Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. Spikevax ® , mRESVIA ® , mNEXSPIKE ® and mCOMBRIAX ® are registered trademarks of Moderna. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential of Moderna's mRNA platform and promise as a multi-modality biotechnology company; Moderna's potential three commercial franchises; Moderna's ability to use data, AI and machine learning, and robotics to drive innovation; anticipated infectious disease launches and geographic expansion; Moderna's late-stage pipeline opportunities in intismeran and propionic acidemia; the potential of mRNA-4194 to address Lynch syndrome and prevent cancer from occurring; Moderna's T-cell engager modality and the encouraging early clinical signal with mRNA-2808; Moderna's in vivo CAR-T modality and the potential in autoimmune diseases; Moderna's ongoing and planned clinical studies; and anticipated progress and milestones for Moderna's programs, including anticipated timing. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. ### Moderna Contacts Media: Chris Ridley Vice President, Global Head of Communications +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire

2026 年开年，两则重磅消息刷屏生物医药圈：苏州瑞博生物登陆港交所，首日市值突破 130 亿港元，成为中国小核酸第一股；葛兰素史克的乙肝反义寡核苷酸药物贝普若韦生在中日同步申报上市，有望成为全球首个乙肝功能性治愈的有限疗程药物。 而就在几个月前，诺华以 120 亿美元天价收购抗体 - 寡核苷酸偶联（AOC）龙头 Avidity，创下小核酸领域史上最大并购案。从新冠疫苗的一战成名，到如今在罕见病、慢病、肿瘤领域全面开花，核酸药物终于完成了从 “技术验证” 到 “商业爆发” 的破茧，正式开启属于自己的黄金十年。 一、从 “死亡之谷” 到千亿赛道，核酸药物的逆袭之路 核酸药物被称为继小分子、抗体之后的第三次制药革命，其核心优势在于直接作用于基因转录翻译的上游环节，能靶向传统药物无法触及的 80%“不可成药” 靶点。 但这条赛道的发展并非一帆风顺： •1998 年，全球首款小核酸药物 Vitravene 获批上市，却因销售额惨淡在 2006 年退市，随后多个临床项目失败，让大药企纷纷撤离； •2013 年起，化学修饰技术和递送系统的双重突破，让行业迎来复苏。肝靶向 GalNAc 偶联技术、脂质纳米颗粒（LNP）的成熟，解决了核酸分子稳定性差、靶向递送难的核心痛点； •2020 年，mRNA 新冠疫苗的全球普及，让核酸技术完成了最大规模的临床验证，也彻底点燃了资本市场的热情。 截至 2025 年底，全球已有20 余款核酸药物获批上市，小核酸药物市场规模突破 70 亿美元，其中诺华的降脂药英克司兰、Alnylam 的 ATTR 药物 Amvuttra 年销售额均突破 10 亿美元，跻身 “重磅炸弹” 行列。UBS 预测，到 2031 年全球核酸药物市场规模将突破 2000 亿元人民币。 二、双轮驱动：mRNA 与小核酸各领风骚 （一）mRNA：后新冠时代，从疫苗到治疗的全面转型 新冠疫情让 mRNA 技术一战成名，但如今其应用早已超越抗感染疫苗，向肿瘤治疗、蛋白替代、细胞疗法等领域深度延伸。 1. 肿瘤疫苗：通用型与个性化双线并进 mRNA 肿瘤疫苗是当前最热门的研发方向，凭借研发周期短、可同时激活体液和细胞免疫的优势，成为继 PD-1 之后肿瘤免疫的下一代核心技术。 •通用型疫苗：靶向 HPV、HBV 等病毒驱动型肿瘤，以及 TERT、WT1 等广谱肿瘤抗原，可规模化生产，成本更低。国内圆因生物的 TI-0093、威斯津生物的 WGc-0201 均已进入临床； •个性化疫苗：基于患者肿瘤基因组测序定制新生抗原，精准解决肿瘤异质性难题。Moderna 的 mRNA-4157 联合帕博利珠单抗治疗黑色素瘤已进入 3 期临床，国内新合生物、立康生命等企业的管线也已推进至 1 期。 2. 治疗性药物：开辟全新治疗范式 mRNA 药物通过在体内编码功能性蛋白，实现对疾病的精准干预，目前已形成四大治疗路径： •体内 CAR-T 疗法：无需体外分离扩增 T 细胞，通过 mRNA 直接在体内编辑免疫细胞，大幅降低治疗成本。Cartesian 的 Descartes-08 治疗重症肌无力已进入 3 期，国内石药集团、虹信生物的管线也已获批临床； •蛋白替代疗法：用于治疗单基因遗传病，Moderna 的甲基丙二酸血症、苯丙酮尿症管线已进入 2 期，国内环码生物的环状 RNA 药物 HD2002 用于缺血性心脏病已获批临床； •细胞因子与抗体疗法：艾博生物的 IL-12 mRNA、BioNTech 的双特异性抗体 mRNA 均已进入临床，让患者体内成为 “生物反应器”。 3. 下一代抗感染疫苗：带状疱疹与 RSV 成主战场 新冠退潮后，带状疱疹和呼吸道合胞病毒（RSV）成为 mRNA 疫苗的核心赛道。2024 年 Moderna 的 RSV 疫苗 mRESVIA 获批上市，成为首款非新冠 mRNA 疫苗。国内艾博生物、嘉晨西海、深信生物等企业的带状疱疹 mRNA 疫苗均已进入 2 期临床，冻干剂型的突破让 mRNA 疫苗摆脱了超低温冷链的限制。 （二）小核酸：从罕见病到慢病，打开万亿市场空间 小核酸药物（siRNA、ASO、miRNA 等）凭借长效给药的核心优势，率先完成了从罕见病到慢病的商业化跨越，成为当前核酸药物市场的主力军。 1. siRNA：慢病领域的 “长效神药” siRNA 通过 RNA 干扰机制沉默致病基因，单次给药可维持 3-6 个月疗效，彻底改变了慢病患者每日服药的治疗模式。 •心血管代谢：成为最拥挤的赛道，覆盖高血脂、高血压、肥胖等亿级患者。诺华的英克司兰 2025 年销售额达 11.98 亿美元，国内舶望制药的降压药 BW-00163、圣因生物的减重药 SGB-7342 均已进入临床； •罕见病：已形成体系化攻克能力，全球 8 款获批 siRNA 药物中有 6 款针对罕见病。2025 年赛诺菲的血友病药物 Fitusiran、Arrowhead 的家族性乳糜微粒血症药物 Plozasiran 相继获批。 2. ASO：神经与肝病领域的领跑者 反义寡核苷酸（ASO）凭借可通过鞘内给药突破血脑屏障的优势，在中枢神经系统疾病中占据主导地位。渤健的脊髓性肌萎缩症药物诺西那生钠累计销售额已超 140 亿美元。 而在肝病领域，乙肝功能性治愈成为全球争夺的战略高地。GSK 的贝普若韦生 3 期临床显示，在基线 HBsAg≤1000 IU/mL 的患者中，功能性治愈率显著提升；国内浩博医药的 AHB-137 已进入 3 期，70% 的患者实现 HBsAg 清除，有望成为全球首批乙肝治愈药物。 3. 新兴模态：saRNA、miRNA 崭露头角 小激活 RNA（saRNA）通过上调抑癌基因表达，为基因表达上调类疾病提供了全新策略。中美瑞康的 RAG-1C 成为国内首个获批临床的 saRNA 药物，用于治疗增殖性玻璃体视网膜病变。2025 年诺华以 17 亿美元收购 miRNA 企业 Regulus，也标志着这一赛道的价值得到认可。 三、核心引擎：递送技术的全域突破 如果说核酸序列是药物的 “灵魂”，那么递送系统就是药物的 “躯体”。长期以来，递送技术是制约核酸药物发展的最大瓶颈，而如今这一领域正迎来从 “肝内靶向” 到 “全域精准” 的跃迁。 1. 肝靶向技术已臻成熟 LNP 和 GalNAc 是目前最成熟的肝靶向递送技术： •LNP：作为 mRNA 疫苗的核心载体，已实现规模化生产，同时也用于首款 siRNA 药物 Patisiran； •GalNAc：凭借皮下给药、靶向性强、安全性高的优势，成为当前小核酸药物的主流递送方案，全球 8 款获批 siRNA 药物中有 7 款采用该技术。 2. 肝外递送：下一个技术分水岭 突破肝脏限制，实现中枢神经系统、肌肉、肺部、肿瘤等组织的精准递送，是下一代核酸药物的核心竞争力。 •AOC 技术：抗体 - 寡核苷酸偶联物，将抗体的组织特异性与寡核苷酸的基因调控功能结合。诺华 120 亿美元收购 Avidity 正是看中其肌肉靶向 AOC 平台，其首款药物 Del-zotaan 有望 2026 年获批上市； •多肽偶联：通过靶向转铁蛋白受体（TfR）实现肌肉、神经等组织递送，Alnylam、Arrowhead 均在该领域深度布局； •增强型 LNP：通过脂质组分优化和靶向配体修饰，实现肺部、脾脏、大脑等器官的靶向递送。 四、资本与产业共振，中国力量加速崛起 2025 年，中国核酸药物产业迎来资本化爆发期，本土企业从 “跟随式创新” 向 “源头创新” 和 “全球化输出” 跨越。 1. 融资与 IPO：小核酸成资本宠儿 2025 年国内小核酸领域披露 13 起融资事件，总金额超 30 亿元，圣因生物、浩博医药、海昶生物等企业均完成亿元级融资。2026 年 1 月瑞博生物成功上市，拉开了小核酸企业港股 IPO 的序幕，舶望制药、靖因药业、悦康药业等也已启动上市进程。 2. 全球化合作：从 “引进来” 到 “走出去” 中国企业的技术实力得到全球巨头认可，2025 年多项重磅 License-out 交易刷新行业纪录： •舶望制药与诺华达成两项合作，累计获得 3.45 亿美元首付款，潜在总交易额超 93 亿美元，创下中国小核酸领域 BD 天花板； •靖因药业与 CRISPR Therapeutics 合作，获得 9500 万美元首付款及超 8 亿美元里程碑； •维亚臻将普乐司兰钠大中华区权益授权给赛诺菲，获得 1.3 亿美元首付款。 3. 全产业链布局：从研发到生产的全面突破 国内已构建起从核酸合成、化学修饰、递送系统开发到规模化生产的完整产业链。药明生物、Lonza 等企业已建立 AOC 专用生产线，艾博生物、瑞博生物等企业的自主递送平台也突破了国外专利壁垒。 五、展望：四大主线重塑未来医疗版图 破茧之后，核酸药物的黄金十年已然开启。未来行业将沿着四大战略主线深度发展： 1.递送技术全域化：2026-2027 年首批肝外递送药物将上市，彻底打开神经肌肉疾病、实体瘤等市场空间； 2.适应症慢病化：高血脂、高血压、乙肝、肥胖等亿级慢病市场将成为核酸药物的主战场，重塑医疗经济学模型； 3.技术模态多元化：环状 RNA、saRNA、AOC 等新兴技术将逐步成熟，与基因编辑融合实现单基因遗传病的 “一次性治愈”； 4.产业生态全球化：中国企业将凭借成本优势和技术创新，成为全球核酸药物产业链的核心力量，诞生具有全球影响力的 Biopharma。 从实验室里的基础研究，到改变千万患者命运的创新药物，核酸药物用了近五十年的时间完成了破茧成蝶。而这一切，仅仅是一个开始。未来十年，核酸技术将彻底改写人类疾病治疗的历史，让我们共同见证这场医疗革命的到来。 互动话题：你最看好核酸药物哪个赛道的发展？是乙肝治愈、长效降压还是肿瘤疫苗？欢迎在评论区留言分享你的观点～