Zapomeran

新冠疫情后，疫苗开发迎来了前所未有的变革期。在2024-2025这一关键节点，全球疫苗产业在传统平台优化与新型平台迭代上同步加速。整体疫苗开发正朝着“通用化、可及化、智能化”方向迈进。 在此行业快速扩充的关口，我们尝试对2024-2025期间，新型疫苗及传统疫苗的突破性进展进行了整体梳理，尤其是已经迈入临床转化或商业化阶段的高价值项目，力图以全球性的眼光，观察未来疫苗行业的腾飞新方向。 一、新型疫苗平台快速迭代 2024-2025年间，新型疫苗技术迎来了加速应用与产业化突破。在2024-2025年间，国内RNA疫苗（mRNA/circRNA/saRNA）获批临床项目近20项，进入“多病种切入”“版本更新”阶段。重组亚单位疫苗及病毒样颗粒(VLP)平台也通过配方更新、佐剂与结构设计等，继续在监管与覆盖能力上取得实质性进展。 RNA疫苗（mRNA／circRNA/saRNA） 2024年5月1日—University of Florida（UF Health Cancer Center）团队发布其mRNA疫苗用于脑瘤（glioblastoma）治疗的初步人体研究成果[1]。该团队开发了一种基于mRNA的肿瘤疫苗（使用患者自身肿瘤细胞信息+复杂递送机制）并在成人患者中观察到“在48小时内使肿瘤从免疫冷态变为免疫热态”的免疫反应。对mRNA平台而言，它标志着mRNA疫苗不仅限于传染病防控，还可用于复杂肿瘤免疫治疗，体现平台通用性的突破。也说明mRNA的递送和免疫激活机制正被重大改进。 对于circRNA而言，最大的突破性进展莫过于连续三个项目进入临床阶段，原研单位均来自中国。转录本生物放射性口干症的临床项目于2024年10月份获批，环码生物用于治疗缺血性心脏病环状RNA项目于2025年1月获批临床，圆因生物环状RNA药物TI-0093注射液于2025年8月获临床试验默示许可，该项目用于治疗HPV16阳性的晚期复发或转移性实体瘤。临床项目的增多意味着在逐渐突破工艺的同时，质量研究也开始逐步完善。 相较于circRNA，saRNA进展更快，2023年11月，日本厚生劳动省批准了CSL与Arcturus therapeutics联合开发的自复制RNA(saRNA)新冠疫苗：ARCT-154（一款saRNA-LNP冻干制剂），是第一个获批上市的saRNA疫苗。2025年9月份，美国公司Replicate Bioscience公布了其狂犬病saRNA临床项目RBI-4000的8个月耐久性分析数据，在0.1–10 μg剂量方案下，在受试者中可在最长8个月仍检测到中和抗体，且用多种衰减模型比较显示其抗体半衰期与/或耐久性与传统灭活疫苗相当或更优[2]。证明了RNA平台向“更低剂量（成本）、更广覆盖”方向的可行性，是RNA平台从“短期应急”向“长期常规”转变的关键里程碑。 表1、截至目前国内获批紧急使用或进入临床的mRNA疫苗 （部分清单，novoprotein整理，如需完整清单，请在文末添加近岸蛋白小助手） 亚单位／重组蛋白疫苗 2024年8月30日，Novavax（公司）获得美国FDA对其更新配方蛋白/佐剂COVID-19疫苗的紧急使用授权（EUA）[3]。是蛋白/佐剂平台在法规层面被再次认可为主流抗 SARS-CoV-2的可用选项，表明蛋白疫苗（非mRNA）仍具快速迭代并被监管接受的能力。 2024年9月4日，Vaxcyte公司宣布其31价肺炎球菌结合疫苗（VAX-31）在一项针对1015名50岁及以上健康成人的1/2期临床试验中取得了积极结果，并决定推进至更高3期临床[4]。代表多价蛋白/结合疫苗通过扩大覆盖血清型（价型扩展）直接提升公共卫生价值，代表结合疫苗在覆盖率的竞争力上取得实质进展。 表2、截至目前进入商业化阶段的亚单位/重组蛋白疫苗 （部分清单，novoprotein整理，如需完整清单，请在文末添加近岸蛋白小助手） 病毒样颗粒疫苗（VLP） VLP在2024–2025年的真正突破是由临床成功转向监管批准与商业化上市，实现质的飞跃。 2025年3月18日，Bavarian Nordic（公司）推出并在美欧获批商业化其VLP-based Chikungunya疫苗VIMKUNYA™用于12岁以上人群，并启动2-11岁儿童的第III期试验[5]。这是首个以VLP技术在成人/青少年中获准并商业化的针对新兴病原体（Chikungunya）的疫苗，把VLP从“临床候选/研究”阶段推进到使用阶段，证明其在安全性与免疫原性上既能满足监管要求又具备商业化条件。 2024年2月19日，阿斯利康以11亿美元金额完成了对Icosavax公司的收购，并推进 IVX-A12（RSV+hMPV组合蛋白VLP疫苗）至临床中后期[6]。II期数据表明，IVX-A12在接种疫苗一个月后可引发针对RSV和hMPV强大免疫应答，该疫苗已进入到III期临床。大型制药公司对VLP平台的并购与推进说明VLP已被视为可产业化、可规模生产且商业价值明确的平台。对行业来说，意味着资本与产能将加速VLP的广泛应用。 表3、截至目前进入商业化阶段的VLP疫苗 （novoprotein整理，如有错漏，欢迎指正） 二、传统疫苗平台的精进  在2024-2025年间，传统疫苗平台（如减毒/灭活/病毒载体等）虽然相较于新型疫苗平台显得“稳重”，但同样在给药方式、靶点拓展、特殊人群应用、监管规范化等方面有所突破，显著强化了作为“疫苗产业基本盘”的角色。下面列出几个突破性进展： 给药方式创新 2024年4月15日，牛津大学公布了通过气溶胶方式给予减毒版Tuberculosis疫苗（BCG疫苗）的一项人体挑战模型研究[7]，研究中将BCG通过喷雾方式进入肺部，研究其在近似自然感染途径下的安全性与耐受性。这一研究强调传统减毒疫苗不仅在经典的“肌肉/皮下注射”路径上可靠，而且通过更接近病原自然侵入途径（肺部喷雾）进行的给药方式研究，代表了传统平台在“给药方式”与免疫原性增强上的改进。 靶点拓展 2024年9月10日，法国Valneva公司在《Journal of Travel Medicine》杂志上发表其基孔肯雅热减毒活疫苗VLA1553(IXCHIQ®)相关数据[8]，随后该款疫苗成为首款获得FDA批准的基孔肯雅热减毒病毒疫苗用于成人免疫。标志着减毒病毒疫苗平台在全球公共卫生病原体（蚊媒病毒）中的应用扩展，从传统的减毒疫苗（如麻疹、风疹）走向新的病毒类型，从而强化了减毒平台在“新病原／少有疫苗”领域中的价值。 免疫受损人群应用 2025年6月11日，由康希诺生物与中国军事医学科学院生物工程研究所共同研究的腺病毒5型载体的新冠疫苗（Ad5nCoV）在HIV感染者（PLWH）人群中进行研究，显示安全且免疫反应持续至少一年[9]。表明腺病毒载体平台正在扩展至免疫受损人群的应用，这加强了其在“高风险群体疫苗策略”中的地位。 监管规范化 2024年12月20日，中国国家药典委员会发布新版《多糖结合疫苗质量控制技术指南（征求意见稿）》，涉及多糖结合疫苗中“偶联工艺”“纯化工艺”“载体蛋白选择”等[10]。该指南的发布体现监管层面对多糖-蛋白结合疫苗平台的进一步规范与推动，意味着该平台进一步规范化。 未来，无论是新型疫苗还是传统疫苗，技术趋势都将持续向多病种覆盖与多平台融合发展。人工智能的快速进步，为疫苗从抗原设计、结构优化到免疫效果预测提供了前所未有的研发效率。随着多技术平台的疫苗项目不断实现从早期研究到临床验证，再到商业化落地的突破，意味着在面对快速变异的病原体与潜在大流行时，人类将具备更敏捷的响应能力、更高的制造灵活性以及更可持续的免疫保障体系。这不仅代表疫苗研发范式的革新，也预示着疫苗产业正迈入一个以智能化、模块化的新阶段。 近岸蛋白加速新型疫苗疗法的研究开发与转化应用 近岸蛋白提供新型疫苗研发过程中的全流程解决方案，涵盖RNA疫苗、亚单位疫苗、VLP疫苗多核心技术平台，具备从抗原设计、候选分子筛选、工艺建立，到质量控制与评价的能力，团队成员拥有多年人用与兽用疫苗开发经验。 11月14-16日，2025中国疫苗行业协会学术年会在福建厦门召开，本次大会将有中国疫苗行业各研究院所、高等院校、药物研发与生产企业等行业专家展开深入交流，设置了多个分会场主题。近岸蛋白诚邀您在厦门国际会议展览中心，B12展位进行交流。 主题报告 11月15日下午15：10，近岸蛋白董事长朱化星博士将在核酸疫苗分论坛进行题为《高通量RNA合成平台助力候选分子快速筛选》的主题报告，解读高通量应用平台助力新型疫苗开发的进展。 展会信息提前看 近岸蛋白在B12号展台期待与您相遇，共同探讨疫苗行业的前沿技术。扫描下方二维码添加小助手微信（备注：新型疫苗），将会邀您加入新型疫苗技术交流群，定期分享并探讨新型疫苗技术的最新发展。 近岸蛋白小助手 RNA疫苗方面，近岸蛋白支持mRNA、circRNA、saRNA多种技术开发路线，覆盖从候选分子序列优化、通量筛选与生物学评估等过程服务，拥有GMP级T7 RNA聚合酶、加帽酶等关键原料，并完成全套产品FDA DMF备案，已助力20余家客户完成中美IND申报。 在亚单位疫苗开发中，近岸蛋白拥有计算机辅助抗原结构设计与蛋白分析改造能力，支持通过大肠杆菌、酵母、真核、昆虫多表达系统匹配小规模到放大生产。VLP疫苗表达体系具备高效自组装能力，独立开发生产工艺具备高纯度高均一性特点。 会议日程 参考文献 [1] UF-developed mRNA vaccine triggers fierce immune response to fight malignant brain tumor. UF Health Cancer Institute [2] Christian J. Maine, Gaelle Picarda, Shigeki J. Miyake-Stoner et al. Durability of next-generation self-replicating RNA vaccine RBI-4000: a phase 1, randomized open label clinical trial. Nature. Published 2025 Sep 24. [3] FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants. U.S.FOOD&DRUG官网 [4] Summary of VAX-31 Adult 50+ Phase 1/2 Study Topline Data Findings. Vaxcyte官网 [5] Bavarian Nordic官网 [6] AstraZeneca官网 [7] Breakthrough aerosol human infection model gives hope for future tuberculosis vaccine development. University of Oxford News. [8] Lin H Chen, Andrea Fritzer, Romana Hochreiter et al. From bench to clinic: the development of VLA1553/IXCHIQ, a live-attenuated chikungunya vaccine. Journal of Travel Medicine. Published 2024 Sep 10. [9] Pedro Cahn, Luis Barreto, Maria Ines FigueroaImmune et al. response induced by the recombinant novel coronavirus vaccine (Adenovirus type 5 vector) (Ad5-nCoV) in persons living with HIV (PLWH). Plos One. Published 2025 Jun 11. [10] 中国食品药品国际交流中心官网 苏州近岸蛋白质科技股份有限公司（简称近岸蛋白）深耕重组蛋白行业十余年，是一家专注于蛋白质技术与应用解决方案的高新技术企业，主营业务为生物药、体外诊断、mRNA疫苗药物、生命科学基础研究等领域的原料与技术解决方案，包括靶点及因子类蛋白、重组抗体、酶及试剂的研发、生产和销售及相关技术服务。公司在上海、苏州和菏泽建有研发、生产基地。 访问www.novoprotein.com.cn或致电400-600-0940。 点击“阅读原文”，了解会议日程

Encouraging CF interim Phase 2 data support continued and expanded trial design 12-week safety and preliminary efficacy study in up to 20 CF participants planned to start H1 2026 Additional cost reductions planned in fourth quarter to extend cash runway Investor conference call at 4:30 p.m. ET today SAN DIEGO --(BUSINESS WIRE)--Nov. 10, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics and infectious disease vaccines, today announced its financial results for the third quarter ended September 30, 2025 , and provided corporate updates. “We were pleased to share the initial findings of ARCT-032 clinical activity with the CF community last month at the NACFC,” said Joseph Payne , President & CEO of Arcturus Therapeutics . “Conversations at NACFC with CF patients, physicians, investigators and global experts reinforced our commitment to advance ARCT-032 further into development. We look forward to initiating a 12-week safety and preliminary efficacy study in first half of 2026. Our team is also working diligently to achieve alignment with regulatory agencies regarding pivotal studies of ARCT-810 in adults and young children with OTC deficiency.” “The observed mucus plug reduction after 28 days of treatment with ARCT-032 in people with Class I CF is encouraging,” said Denis Hadjiliadis, MD, MMHS, FRCP(C), Professor and Cystic Fibrosis Program Director, Perelman School of Medicine , University of Pennsylvania . “Clearance of mucus suggests that treatment with ARCT-032 is acting on the thick mucus defect which is fundamental in CF; more extended treatment with ARCT-032 could provide further reduction in mucus burden leading to more meaningful benefits, including lung function and structural lung defect improvement. These changes could ultimately lead to reduction in exacerbations and change the clinical course of this progressive disease.” “The sudden changes in regulatory requirements by the FDA for COVID-19 vaccines have delayed the U.S. BLA filing for KOSTAIVE® indefinitely. We have decided to reduce additional expenses to extend the runway for the CF and OTC deficiency programs,” said Andy Sassine , CFO of Arcturus Therapeutics . “We anticipate continued support from CSL to commercialize KOSTAIVE in Asia and Europe and will provide more details on our year end call.” Recent Corporate Highlights Arcturus continues to advance the ARCT-810 program for OTC deficiency. Planned alignment with regulatory agencies around pivotal trial strategy for both pediatric and adult populations remain on track for the first half of 2026. In October, the Company announced interim data from its ongoing Phase 2 clinical trial of ARCT-032 in cystic fibrosis: Treatment with inhaled 10 mg doses of ARCT-032 daily over 28 days in six Class I CF adults received was generally safe and well tolerated. Protocol prespecified analyses of high-resolution computed tomography (HRCT) lung scans using FDA 501(k)-cleared AI technology revealed reductions in mucus burden in four of the six Class I CF participants. The ongoing third cohort is enrolling up to six subjects to assess the safety and tolerability of the 15 mg dose daily over 28 days and the impact on the efficacy endpoints. The Company intends to initiate up to 20 CF participants for 12-weeks of dosing with ARCT-032 in a safety and preliminary efficacy study in the first half of 2026. Meiji Seika Pharma launched the two-dose vial of KOSTAIVE updated for the JN.1 variant XEC in Japan . Meiji received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in August 2025 . In August, the Company published the Phase 3 manuscript on the immunogenicity and safety of a self-amplifying mRNA COVID-19 vaccine (ARCT-2303), with or without co-administration of seasonal inactivated influenza vaccine in adults. The study shows that ARCT-2303 induces a robust immune response against the vaccine variant of SARS-CoV-2 and can be co-administered with licensed influenza vaccines in adults with no impact on the safety or immunogenicity of either vaccine. The results were published in eClinicalMedicine. The Company conducted a Phase 1 study of ARCT-2304 (NCT06602531), an sa-mRNA vaccine candidate for Pandemic Influenza A Virus H5N1. The study objectives were to evaluate the safety and tolerability and to describe the immune response of three different dose levels in 132 young adults (18-59 years of age) and 80 older adults (60-80 years old). ARCT-2304 induced a humoral immune response after a single dose at all tested dose levels. The administration of a second dose of ARCT-2304 further increases immune responses. ARCT-2304 at dose levels 1.5, 5 and 12 µg induce a hemagglutinin-specific immune response similar to or higher than that after the MF59-adjuvanted pandemic vaccine. No safety or tolerability concerns were raised from available data. Overall, the study results support the further development of a self-amplifying mRNA pandemic influenza vaccine candidate. These new data further validate Arcturus’ STARR® sa-mRNA vaccine platform. This work was funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C00007. The contract and federal funding are not an endorsement of the study results, product, or company. Treatment with inhaled 10 mg doses of ARCT-032 daily over 28 days in six Class I CF adults received was generally safe and well tolerated. Protocol prespecified analyses of high-resolution computed tomography (HRCT) lung scans using FDA 501(k)-cleared AI technology revealed reductions in mucus burden in four of the six Class I CF participants. The ongoing third cohort is enrolling up to six subjects to assess the safety and tolerability of the 15 mg dose daily over 28 days and the impact on the efficacy endpoints. The Company intends to initiate up to 20 CF participants for 12-weeks of dosing with ARCT-032 in a safety and preliminary efficacy study in the first half of 2026. The study shows that ARCT-2303 induces a robust immune response against the vaccine variant of SARS-CoV-2 and can be co-administered with licensed influenza vaccines in adults with no impact on the safety or immunogenicity of either vaccine. The results were published in eClinicalMedicine. ARCT-2304 induced a humoral immune response after a single dose at all tested dose levels. The administration of a second dose of ARCT-2304 further increases immune responses. ARCT-2304 at dose levels 1.5, 5 and 12 µg induce a hemagglutinin-specific immune response similar to or higher than that after the MF59-adjuvanted pandemic vaccine. No safety or tolerability concerns were raised from available data. Overall, the study results support the further development of a self-amplifying mRNA pandemic influenza vaccine candidate. These new data further validate Arcturus’ STARR® sa-mRNA vaccine platform. This work was funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C00007. The contract and federal funding are not an endorsement of the study results, product, or company. Financial Results for the three months ended September 30, 2025 Revenues in conjunction with strategic alliances and collaborations: Arcturus’ primary revenue streams include license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research and development arrangements with pharmaceutical and biotechnology partners. Revenue for the three and nine months ended September 30, 2025 , was $17.2 million and $74.8 million , respectively, representing decreases of $24.5 million and $54.7 million compared to the same periods in 2024. These declines were primarily driven by reduced revenue from the CSL collaboration, reflecting lower supply agreement activity and lower amortization of the upfront payment as KOSTAIVE progresses toward commercialization. Operating expenses: Total operating expenses for the three months ended September 30, 2025 , were $33.7 million compared with $52.4 million for the three months ended September 30, 2024 . Total operating expenses for the nine months ended September 30, 2025 , were $119.8 million compared with $191.8 million for the nine months ended September 30, 2024 . Research and development expenses: Research and development expenses consist primarily of external manufacturing costs, in vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel-related expenses, facility-related expenses and laboratory supplies related to conducting research and development activities. Research and development expenses were $23.3 million for the three months ended September 30, 2025 , compared with $39.1 million for the three months ended September 30, 2024 . The decrease was primarily driven by lower manufacturing costs for the LUNAR-COVID, LUNAR-FLU, and LUNAR-CF programs, as well as reduced clinical trial expenses for LUNAR-COVID and LUNAR-CF. Lower payroll and employee benefits further contributed to the decrease. Research and development expenses were $87.7 million for the nine months ended September 30, 2025 , compared with $151.4 million for the nine months ended September 30, 2024 . The decrease was primarily driven by lower manufacturing and clinical costs related to the LUNAR-COVID program, reflecting the program’s transition from a development program to the commercial phase. Additional decreases were attributable to lower manufacturing costs for the LUNAR-CF and LUNAR-FLU programs. These reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program. Payroll and benefits expenses also decreased, primarily due to lower stock-based compensation expense. General and Administrative Expenses: General and administrative expenses primarily consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional service fees for legal and accounting services as well as other general and administrative expenses. General and administrative expenses were $10.4 million and $32.1 million for the three and nine months ended September 30, 2025 , respectively, compared with $13.3 million and $40.4 million in the comparable periods last year. The decreases in both periods were primarily due to reduced share-based compensation expense as well as reduced payroll and benefits. We expect general and administrative expenses to continue to decrease slightly during the next twelve months driven by lower share-based compensation costs. Net Loss: For the three months ended September 30, 2025 , Arcturus reported a net loss of approximately $13.5 million , or ( $0.49 ) per diluted share, compared with a net loss of $6.9 million , or ( $0.26 ) per diluted share in the three months ended September 30, 2024 . For the nine months ended September 30, 2025 , Arcturus reported a net loss of approximately $36.7 million , or ( $1.35 ) per diluted share, compared with a net loss of $50.9 million , or ( $1.89 ) per diluted share in the nine months ended September 30, 2024 . Cash Position and Balance Sheet: Cash, cash equivalents and restricted cash were $237.3 million as of September 30, 2025 , compared to $293.9 million on December 31, 2024 . Based on the additional planned cost reduction in Q4 2025 and the delay in Phase 3 CF clinical trial commencement until 2027, the cash runway remains extended into 2028. Earnings Call: Monday, November 10, 2025 @ 4:30 p.m. ET Domestic: 1-800-274-8461 International: 1-203-518-9814 Conference ID: ARCTURUS Webcast: Link About Arcturus Founded in 2013 and based in San Diego, California , Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan , ARCALIS , focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat OTC deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S. , Europe , Japan , China , and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on X (formerly Twitter) and LinkedIn. 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. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success of the Company’s pipeline (including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood that clinical data, including interim data, will be predictive of future clinical results, the likelihood that observed mucus plug reduction is predictive of future and future reduction and will lead to lung function or structural lung defect improvements, the plans to enroll subjects in the third cohort of the Phase 2 clinical trial of ARCT-032, the likelihood and timing for initiation, and size and scope, of a planned 12-week safety and preliminary efficacy study for ARCT-032, plans to advance ARCT-032 further into development, the likelihood and timing for achieving alignment with regulatory agencies on pivotal studies for ARCT-810, the likelihood of success of any collaboration including the anticipated continued support from CSL to commercialize KOSTAIVE, the continued determination that ARCT-032 is generally safe and well tolerated, the likelihood of further development of a self-amplifying mRNA pandemic influenza vaccine candidate, the likelihood that preclinical or clinical data will be predictive of future clinical results, the likelihood that general and administrative expenses will continue to decrease, its current cash position and expected cash burn and runway, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC , which are available on the SEC’s website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS September 30 , 2025 December 31 , 2024 (in thousands, except par value information) (unaudited) Assets Current assets: Cash and cash equivalents $ 180,360 $ 237,028 Restricted cash 55,000 55,000 Accounts receivable 7,951 3,974 Prepaid expenses and other current assets 5,889 9,977 Total current assets 249,200 305,979 Property and equipment, net 7,419 9,531 Operating lease right-of-use assets, net 23,839 26,674 Non-current restricted cash 1,885 1,885 Total assets $ 282,343 $ 344,069 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 5,491 $ 7,194 Accrued liabilities 19,382 38,781 Deferred revenue 6,826 19,514 Total current liabilities 31,699 65,489 Deferred revenue, net of current portion 4,220 12,604 Operating lease liability, net of current portion 21,865 24,998 Total liabilities 57,784 103,091 Stockholders’ equity Common stock, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 27,235 at September 30, 2025 and 27,096 at December 31, 2024 27 27 Additional paid-in capital 710,043 689,758 Accumulated deficit (485,511 ) (448,807 ) Total stockholders’ equity 224,559 240,978 Total liabilities and stockholders’ equity $ 282,343 $ 344,069 ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) Three Months Ended Nine Months Ended September 30 , September 30 , (in thousands, except per share data) 2025 2024 2025 2024 Revenue: Collaboration revenue $ 14,153 $ 38,815 $ 64,140 $ 117,389 Grant revenue 2,998 2,858 10,695 12,155 Total revenue 17,151 41,673 74,835 129,544 Operating expenses: Research and development, net 23,265 39,134 87,736 151,376 General and administrative 10,398 13,276 32,052 40,443 Total operating expenses 33,663 52,410 119,788 191,819 Loss from operations (16,512 ) (10,737 ) (44,953 ) (62,275 ) Loss from foreign currency (170 ) (201 ) (319 ) (642 ) Finance income, net 3,234 3,818 8,572 11,981 Net loss before income taxes (13,448 ) (7,120 ) (36,700 ) (50,936 ) Provision (benefit) for income taxes — (217 ) 4 — Net loss $ (13,448 ) $ (6,903 ) $ (36,704 ) $ (50,936 ) Net loss per share, basic and diluted $ (0.49 ) $ (0.26 ) $ (1.35 ) $ (1.89 ) Weighted-average shares outstanding, basic and diluted 27,188 27,062 27,142 26,970 Comprehensive loss: Net loss $ (13,448 ) $ (6,903 ) $ (36,704 ) $ (50,936 ) Comprehensive loss $ (13,448 ) $ (6,903 ) $ (36,704 ) $ (50,936 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20251110988919/en/ Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com Source: Arcturus Therapeutics Holdings Inc.