SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, and CSL (ASX:CSL), and its vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, announced today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

SAN DIEGO--（BUSINESS WIRE）-Arcturus Therapeutics Holdings Inc.（the“Company”，“Arcturus”，纳斯达克股票代码：ARCT），一家全球晚期临床信使RNA药物公司，专注于开发传染病疫苗和肝脏和呼吸系统罕见疾病的机遇，以及CSL（ASX:CSL）及其疫苗业务CSL Sequirus，世界上最大的流感疫苗供应商之一今天宣布，欧洲药品管理局（EMA）已经验证了下一代mRNA疫苗ARCT-154的上市许可申请（MAA），用于主动免疫以预防COVID-19由SARS-CoV-2引起的18岁及以上人群。

The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024..

这些公司（Arcturus和CSL-Seqirus）预计将于2024年获得欧盟委员会的批准。。

The EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths.

EMA提交的依据是ARCT-154针对祖先D614G变体作为主要系列和增强剂的成功3期临床结果。在对关键性3期研究的6个月数据的分析中，主要疗效终点得到满足，ARCT-154作为主要系列结果，总体预防症状性COVID-19的疗效为56.6%，预防为95.3%包括COVID-19相关死亡在内的严重COVID-19。

The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus’ partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV-2 ancestral strain compared to Comirnaty®.

这项研究是在越南以Delta变体为主的情况下进行的。加强数据结果之前由CSL-Seqirus的合作伙伴Meiji Seika Pharma公布，表明主要终点是在3期加强疫苗研究中通过证明针对SARS-CoV-2祖先菌株的免疫应答的非劣效性来实现的。Comirnaty®。

Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was a key secondary endpoint..

ARCT-154在针对SARS-CoV-2 Omicron BA.4/5变体的中和抗体应答中的优势是关键的次要终点。。

“EMA acceptance of the marketing application for ARCT-154 represents another major achievement in the development of this innovative mRNA vaccine platform. This is also an important milestone for Arcturus and our global exclusive partner, CSL Seqirus, as we work towards achieving approval in Europe,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

“EMA接受ARCT-154的营销申请代表了这一创新mRNA疫苗平台开发的另一项重大成就，这也是Arcturus和我们的全球独家合作伙伴CSL-Seqirus的一个重要里程碑，因为我们正在努力实现批准Arcturus Therapeutics总裁兼首席执行官Joseph Payne说。

“ARCT-154 is expected to be efficiently updated as new variants of concern arise and has the potential to be a longer lasting vaccine against the pervasive and ever-changing COVID virus.”.

“随着新的关注变体的出现，ARCT-154有望得到有效更新，并有可能成为针对普遍且不断变化的新型冠状病毒的更持久的疫苗。”。

“This pivotal regulatory milestone brings CSL one step closer to bringing innovative mRNA vaccines to Europe,” said Emmanuelle Lecomte Brisset, Head of Global Regulatory Affairs at CSL. “We look forward to working with regulatory authorities to continue to advance how we protect public health.”

CSL全球监管事务负责人Emmanuelle Lecomte Brisset说：“这一关键的监管里程碑使CSL更接近将创新的mRNA疫苗推向欧洲。”。“我们期待与监管机构合作，继续推进我们如何保护公众健康。”

About Arcturus Therapeutics

关于Arcturus疗法

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise.

Arcturus Therapeutics Holdings Inc.（纳斯达克股票代码：ARCT）成立于2013年，总部位于加利福尼亚州圣地亚哥，是一家全球晚期临床mRNA药物和疫苗公司，拥有以下技术：（i）LUNAR®lipid mediated delivery，（ii）STARR®mRNA技术（samRNA）和（iii）mRNA药物以及药品制造专业知识。

The Company has an ongoing exclusive global collaborative partnership for innovative mRNA vaccines with CSL Seqirus. The Company also has a joint venture with the Japanese CMO, ARCALIS. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered innovative mRNA vaccine programs for SARS-CoV-2 (COVID-19), influenza, pandemic preparedness and a range of other respiratory pathogens.

该公司与CSL-Seqirus公司建立了创新mRNA疫苗的独家全球合作伙伴关系。该公司还与日本CMO ARCALIS合资。Arcturus的管道包括潜在治疗鸟氨酸转氨甲酰酶缺乏症和囊性纤维化的RNA治疗候选药物，以及其针对SARS-CoV-2（COVID-19），流感，大流行防范和一系列其他呼吸道病原体的合作创新mRNA疫苗计划。

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 (patents and patent applications issued in the U.S., Europe, Japan, China, and other countries).

Arcturus的多功能RNA治疗平台可应用于多种类型的核酸药物，包括信使RNA，小干扰RNA，环状RNA，反义RNA，自扩增RNA，DNA和基因编辑治疗。Arcturus的技术涵盖其广泛的专利组合（在美国，欧洲，日本，中国和其他国家/地区发布的专利和专利申请）。

For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn..

欲了解更多信息，请访问www.ArcturusRx.com。此外，请在Twitter和LinkedIn上与我们联系。。

About CSL

关于CSL

CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

CSL（ASX:CSL）（USOTC:CSLLY）是一家全球生物技术公司，拥有动态的救生药物组合，包括治疗血友病和免疫缺陷的药物，预防流感的疫苗以及缺铁和肾脏病的治疗药物。自1916年开始以来，我们一直致力于使用最新技术拯救生命的承诺。

Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

如今，CSL（包括我们的三个业务：CSL Behring，CSL Sequirus和CSL Vifor）为100多个国家的患者提供救生产品，雇用32000人。我们独特的商业优势，研发重点和卓越运营组合使我们能够识别，开发和提供创新，使患者能够充分发挥生活。

For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL..

有关生物技术承诺的鼓舞人心的故事，请访问CSLBehring.com/Vita并在Twitter.com/CSL上关注我们。。

For more information about CSL, visit www.CSL.com.

有关CSL的更多信息，请访问www.CSL.com。

Forward Looking Statements

前瞻性声明

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 ARCT-154 and the partnered COVID-19 program, the timing for an approval decision by the European Commission for ARCT-154, the likelihood that any clinical data will be predictive of future clinical results, the likelihood that the interim study results of the ARCT-154 Phase 3 booster vaccine study will be predictive of, or consistent with, the complete study results, the potential for ARCT-154 to be a longer lasting vaccine, and the impact of general business and economic conditions.

本新闻稿包含前瞻性声明，其中涉及1995年“私人证券诉讼改革法”提供的安全港的重大风险和不确定性。除了本新闻稿中包含的历史事实陈述外，任何陈述都是前瞻性陈述，包括有关战略，未来运营，ARCT-154和合作COVID-19计划成功的可能性，欧盟委员会批准ARCT-154决定的时间，任何临床数据都有可能预测未来的临床结果，ARCT-154 3期加强疫苗研究的中期研究结果可能预测或符合完整的研究结果，ARCT-154成为更持久的疫苗，以及一般商业和经济条件的影响。

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.

Arcturus可能无法实际实现计划，执行意图或满足上述任何前瞻性声明中披露的期望或预测，您不应过分依赖此类前瞻性声明。这些陈述仅是当前的预测或预期，并受到已知和未知的风险，不确定性以及其他可能导致我们或我们行业的实际结果，活动水平，绩效或成就与预期的实质性不同的因素。展望声明，包括在Arcturus的“风险因素”标题下讨论的表格10-K的最新年度报告，以及随后提交给SEC的文件或提交给SEC的文件，这些文件可在SEC的网站www.SEC.gov上找到。

Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or .

除法律另有要求外，Arcturus不承担更新or的任何意图或义务。

Trademark Acknowledgements

商标确认

The Arcturus logo and other trademarks of Arcturus appearing in this announcement, including LUNAR® and STARR®, are the property of Arcturus. All other trademarks, services marks, and trade names in this announcement are the property of their respective owners.

本公告中出现的Arcturus徽标和Arcturus的其他商标，包括LUNAR®和STARR®，均为Arcturus的财产。本公告中的所有其他商标，服务标志和商品名称均为其各自所有者的财产。