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 medicines to treat unmet medical needs within liver and respiratory rare diseases, today announced Arcturus will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic to treat CF, at the 47th European Cystic Fibrosis Conference on June 7, 2024..

圣地亚哥--（商业新闻短讯）--Arcturus Therapeutics Holdings Inc.（以下简称“公司”，“Arcturus”，纳斯达克：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药物，以治疗肝脏和呼吸系统罕见疾病中未满足的医疗需求，今天宣布Arcturus将在2024年6月7日举行的第47届欧洲囊性纤维化会议上，为健康志愿者提供ARCT-032（一种用于治疗CF的吸入性研究性mRNA治疗剂）的CF患者的第一阶段结果和新的1b期中期数据。。

“We were pleased to observe ARCT-032 treatments for the first four patients were generally safe and well tolerated with no serious adverse events,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “Furthermore, we observed an encouraging trend towards lung function improvements in the first four CF participants after only two inhaled administrations.”.

Arcturus Therapeutics总裁兼首席执行官约瑟夫·佩恩（JosephPayne）表示：“我们很高兴观察到，前四名患者的ARCT-032治疗总体上是安全的，耐受性良好，没有严重的不良事件。”。“此外，我们观察到前四名CF参与者在仅两次吸入给药后肺功能改善的令人鼓舞的趋势。”。

“The absolute change in percent predicted FEV1 (Forced Expiratory Volume in 1 second) in the first four CF participants was observed to be an average of 4.0% at day 8,” said Dr. Juergen Froehlich, Chief Medical Officer of Arcturus Therapeutics. “I am pleased to announce our team will present this new Phase 1b interim data at the upcoming European CF conference in Scotland, supplementing the favorable results from our Phase 1 single ascending dose study in healthy volunteers.”.

Arcturus Therapeutics首席医疗官Juergen Froehlich博士说：“前四名CF参与者预测FEV1百分比（1秒用力呼气量）的绝对变化在第8天平均为4.0%。”。“我很高兴地宣布，我们的团队将在即将在苏格兰举行的欧洲CF会议上展示这一新的1b期中期数据，补充我们在健康志愿者中进行的第一阶段单次递增剂量研究的有利结果。”。

About Cystic Fibrosis

关于囊性纤维化

Cystic fibrosis is a life-shortening disease with a worldwide distribution. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing insufficient chloride transport to maintain airway surface homeostasis.

囊性纤维化是一种寿命缩短的疾病，在世界范围内分布。囊性纤维化跨膜电导调节剂（CFTR）基因的突变导致气道中CFTR蛋白和/或功能的减少或缺失，导致氯化物转运不足以维持气道表面稳态。

CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, respiratory failure, or other life-threatening complications. Currently approved CFTR modulator therapies are designed to increase function of the CFTR channel to help reduce symptoms yet are ineffective in some people with CF because of their underlying mutations..

CF粘液更难清除，从而阻塞气道并导致感染，炎症，呼吸衰竭或其他危及生命的并发症。目前批准的CFTR调节剂疗法旨在增加CFTR通道的功能，以帮助减轻症状，但由于其潜在的突变，对某些CF患者无效。。

About ARCT-032

关于ARCT-032

ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR® lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs.

ARCT-032已获得欧洲药品管理局（EMA）的孤儿药品指定和美国食品和药物管理局（FDA）的孤儿药指定，用于治疗囊性纤维化。ARCT-032利用大角星的LUNAR®脂质介导的雾化平台将CFTR信使RNA递送至肺部。

Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells..

CF患者肺部CFTR mRNA功能拷贝的表达有可能恢复CFTR活性并减轻导致进行性肺部疾病的下游影响。ARCT-032计划得到了啮齿动物，雪貂和灵长类动物的临床前数据的支持，并证明了CFTR在人支气管上皮细胞中表达和功能的恢复。。

About Arcturus Therapeutics

关于大角星治疗学

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global 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 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mRNA药物和疫苗公司，拥有以下技术：（i）LUNAR®脂质介导的递送，（ii）STARR®mRNA技术（sa mRNA）和（iii）mRNA药物以及药品制造专业知识。

Arcturus developed the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine (Kostaive®) 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.

大角星开发了世界上第一种自我扩增信使RNA（sa mRNA）新型冠状病毒疫苗（Kostaive®），并获得批准。Arcturus正在与CSL-Seqirus进行创新mRNA疫苗的全球合作，并在日本成立了一家合资企业ARCALIS，专注于mRNA疫苗和治疗剂的生产。

Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, 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的管道包括可能治疗鸟氨酸转氨甲酰酶缺乏症和囊性纤维化的RNA治疗候选物，以及针对SARS-CoV-2（COVID-19）和流感的合作mRNA疫苗计划。大角星的多功能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和基因编辑疗法。

Arcturus’ technologies are covered by its extensive patent portfolio (over 400 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 Twitter and LinkedIn..

大角星的技术涵盖了其广泛的专利组合（在美国、欧洲、日本、中国和其他国家拥有400多项专利和专利申请）。有关更多信息，请访问www.ArcturusRx.com。此外，请通过Twitter和LinkedIn与我们联系。。

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 expectations for or likelihood of success of any collaborations, the continued clinical development of ARCT-032 including the ability to complete and timing for completion of the CF Phase 1b study, likelihood of success (including safety and efficacy) of ARCT-032, the likelihood that the interim results will be predictive of future clinical results, the likelihood of sharing and timing for sharing interim and final Phase 1b data, and the impact of general business and economic conditions.

本新闻稿包含前瞻性声明，涉及1995年《私人证券诉讼改革法案》提供的安全港的重大风险和不确定性。除本新闻稿中包含的历史事实声明外，任何声明都是前瞻性声明，包括有关战略，未来运营，任何合作成功的期望或可能性，ARCT-032的持续临床开发，包括完成CF 1b期研究的能力和时间，ARCT-032成功的可能性（包括安全性和有效性），中期结果预测未来临床结果的可能性，共享中期和最终1b期数据的可能性和时间，以及一般商业和经济状况的影响。

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.

大角星可能无法实际实现上述任何前瞻性声明中披露的计划、意图或期望或预测，您不应过度依赖此类前瞻性声明。这些声明仅是当前的预测或预期，并受到已知和未知的风险、不确定性和其他因素的影响，这些因素可能导致我们或我们行业的实际业绩、活动水平、绩效或成就与前瞻性声明所预期的大不相同，包括Arcturus最新年度报告（表10-K）中“风险因素”标题下讨论的内容，以及随后向美国证券交易委员会提交的文件或提交给美国证券交易委员会的文件，这些文件可在美国证券交易委员会网站www.SEC.gov上查阅。

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

除非法律另有规定，大角星不承担更新或修订任何远期信用证的任何意图或义务。