Arcturus Therapeutics Holdings Inc (ARCT) 2022 Q4 法說會逐字稿

Greetings, and welcome to Arcturus Therapeutics Fourth Quarter 2022 Financial Update and Pipeline Progress Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. You may begin.

您好，歡迎來到 Arcturus Therapeutics 2022年第四季度財務更新和管道進展電話會議。 （操作員說明）提醒一下，正在錄製此會議。現在我很高興向您介紹主持人，副總裁兼投資者關係、公共關係和營銷主管 Neda Safarzadeh。你可以開始了。

Thank you, operator. Good afternoon, and welcome to Arcturus Therapeutics Fourth Quarter 2022 Financial Update and Pipeline Progress call. Today's call will be led by Joseph Payne, our President and CEO; and Andy Sassine, our CFO; Dr. Pad Chivukula, our CSO and COO, will join in for the Q&A session as well.

謝謝你，運營商。下午好，歡迎來到 Arcturus Therapeutics 2022 年第四季度財務更新和管道進展電話會議。今天的電話會議將由我們的總裁兼首席執行官 Joseph Payne 主持；和我們的首席財務官 Andy Sassine；我們的 CSO 兼首席運營官 Pad Chivukula 博士也將參加問答環節。

Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by this statement.

在我們開始之前，我想提醒大家，在本次電話會議中就非歷史事實的事項所做的陳述是 1995 年《私人證券訴訟改革法案》安全港條款內的前瞻性陳述。前瞻性陳述不是性能的保證。它們涉及已知和未知的風險、不確定性和假設，可能導致實際結果、績效和成就與本聲明明示或暗示的結果、業績和成就存在重大差異。

Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our Form 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such as statements are made. Arcturus specifically disclaims any obligation to update such statements to reflect future information, events or circumstances.

請參閱公司今天早些時候發布的新聞稿中的前瞻性聲明免責聲明以及我們向美國證券交易委員會提交的 10-K 表格中的風險因素部分。此外，任何前瞻性陳述僅代表我們截至此類陳述作出之日的觀點。 Arcturus 特別聲明不承擔任何更新此類聲明以反映未來信息、事件或情況的義務。

And with that, I will now turn the call over to Joe.

有了這個，我現在將把電話轉給喬。

Thank you, Neda, and good afternoon to all. Thank you for joining us for today's call. The recent period has been characterized by substantial operational and pipeline progress here at Arcturus. We will be highlighting 4 areas on today's update call. First, we closed our strategic vaccine collaboration agreement with CSL Seqirus at the end of last year. We have received the $200 million upfront payment and invoiced $90 million in additional milestones, demonstrating the positive progress that the companies have made on our partnered COVID and seasonal flu vaccine programs.

謝謝你，Neda，大家下午好。感謝您加入我們今天的電話會議。最近一段時間的特點是 Arcturus 在運營和管道方面取得了實質性進展。我們將在今天的更新電話會議上強調 4 個方面。首先，我們在去年底與 CSL Seqirus 達成了戰略疫苗合作協議。我們已經收到了 2 億美元的預付款，並為其他里程碑開具了 9000 萬美元的發票，這表明這些公司在我們合作的 COVID 和季節性流感疫苗計劃方面取得了積極進展。

Second, we've entered into an agreement with Meiji Pharma to evaluate ARCT-154 as a booster vaccine for SARS-CoV-2, also known as COVID-19, and we're very happy to report significant operational progress in the ongoing Phase III study in Japan, and we'll be providing an update there.

其次，我們已經與明治製藥達成協議，評估 ARCT-154 作為 SARS-CoV-2（也稱為 COVID-19）的加強疫苗，我們很高興地報告正在進行的階段的重大運營進展III 在日本學習，我們將在那裡提供更新。

Third, we have continued to advance our RNA platform technology and our earlier stage clinical programs and we will provide an update on recent progress there. Fourth, we have strengthened our management team by the addition of Dr. Jürgen Fralick, as our Chief Medical Officer, overseeing mRNA therapeutics and Dr. Igor Smolenov as our Chief Development Officer, overseeing clinical development of our vaccine franchise.

第三，我們繼續推進我們的 RNA 平台技術和我們的早期臨床項目，我們將提供最新進展。第四，我們加強了我們的管理團隊，增加了 Jürgen Fralick 博士作為我們的首席醫療官，負責監督 mRNA 療法，以及 Igor Smolenov 博士作為我們的首席開發官，負責監督我們疫苗專營權的臨床開發。

I'll begin with our recently announced strategic collaboration with CSL. We are in the initial phase of our now 4-month-old collaboration and very pleased with how the teams are working together. Arcturus has achieved substantial milestones this month associated with nominating next-generation candidates for COVID and seasonal flu programs.

我將從我們最近宣布的與 CSL 的戰略合作開始。我們正處於 4 個月大合作的初始階段，對團隊的合作方式非常滿意。 Arcturus 本月在提名 COVID 和季節性流感項目的下一代候選人方面取得了重大里程碑。

Mutual respect is evident between the working groups of both companies. There is a clear passion and solid work ethic behind the competent execution that has led to these important and early milestones being achieved. We remain eligible for additional development and commercial milestones as covered pipeline programs advance.

兩家公司的工作組之間相互尊重是顯而易見的。勝任的執行背後有著清晰的熱情和紮實的職業道德，這導致了這些重要的早期里程碑的實現。隨著涵蓋的管道計劃的推進，我們仍然有資格獲得額外的開發和商業里程碑。

Our collaboration with CSL is focused on the development and commercialization of next-generation mRNA vaccines targeting COVID, influenza, 3 additional pathogens as well as pandemic preparedness. Our collaboration combines CSL's well-established global vaccine commercial and manufacturing infrastructure with Arcturus' mRNA manufacturing expertise, and the innovative Star mRNA vaccine and LUNAR delivery platform technologies.

我們與 CSL 的合作重點是開發和商業化針對 COVID、流感、另外 3 種病原體的下一代 mRNA 疫苗以及大流行病防範。我們的合作將 CSL 完善的全球疫苗商業和製造基礎設施與 Arcturus 的 mRNA 製造專業知識以及創新的 Star mRNA 疫苗和 LUNAR 交付平台技術相結合。

We expect this collaboration to drive the development, manufacture and global commercialization of next-generation self-amplifying mRNA vaccines over the coming years. The impact of this collaboration to our balance sheet runway continues to be meaningful, and Andy will be speaking to that shortly.

我們預計此次合作將在未來幾年推動下一代自擴增 mRNA 疫苗的開發、製造和全球商業化。這種合作對我們的資產負債表跑道的影響仍然是有意義的，安迪很快就會談到這一點。

Now on to our agreement with Meiji Pharma to advance ARCT-154 development in Japan. Our contracted relationship with Meiji is focused on developing ARCT-154. This is our next-generation self-amplifying mRNA booster vaccine for COVID-19. You may already appreciate that Japan has one of the world's highest rates of covid booster vaccination. Given the Japanese government's focus on public health and infectious disease prevention, we fully expect high levels of COVID booster at utilization for many years to come.

現在我們與明治製藥達成協議，以推進日本的 ARCT-154 開發。我們與明治的合同關係專注於開發 ARCT-154。這是我們針對 COVID-19 的下一代自擴增 mRNA 加強疫苗。您可能已經意識到日本是世界上新冠病毒加強疫苗接種率最高的國家之一。鑑於日本政府對公共衛生和傳染病預防的關注，我們完全預計未來許多年會出現高水平的 COVID 助推器。

In addition, the Japanese government has been clear about their interest in establishing independence in mRNA vaccines, and we're very pleased to be part of this effort with Meiji. Meiji Group received a significant subsidy from the Japanese government in the fourth quarter of 2022 to support this effort, and Meiji is responsible for all development costs related to ARCT-154 in Japan.

此外，日本政府已經明確表示他們有興趣在 mRNA 疫苗方面建立獨立性，我們很高興能與明治一起參與這項工作。明治集團在 2022 年第四季度從日本政府獲得了一筆巨額補貼以支持這項工作，明治集團負責日本與 ARCT-154 相關的所有開發費用。

In December 2022, we announced that Meiji had initiated a Phase III booster study in Japan designed to compare ARCT-154 to Comirnaty in targeting 780 adult participants based on noninferiority immunogenicity. Meiji moved quickly with the enrollment process. Very impressed and appreciative with the productivity and progress we've seen there.

2022 年 12 月，我們宣布明治在日本啟動了一項 III 期加強研究，旨在基於非劣效性免疫原性比較 ARCT-154 與 Comirnaty 針對 780 名成人參與者的效果。明治在招生過程中行動迅速。我們在那裡看到的生產力和進步給我們留下了深刻的印象和讚賞。

I'm very pleased to report today that the study is now fully enrolled with over 800 participants exceeding our target enrollment and ahead of schedule. In addition, the 1-month follow-up visits and the 1-month blood draws have also been completed. This timely execution allows us to immediately collect the prerequisite immunogenicity data and be in a position to potentially file our first NDA in Japan.

今天我很高興地報告說，這項研究現在已經完全註冊，超過 800 名參與者超過了我們的目標註冊人數，並且提前完成。此外，1個月的隨訪和1個月的抽血也已經完成。這種及時的執行使我們能夠立即收集必要的免疫原性數據，並有可能在日本提交我們的第一個 NDA。

Now moving to our earlier stage programs, and I'll begin with ARCT-810. This is our therapeutic candidate for ornithine transcarbamylase deficiency or OTC deficiency. This investigational therapeutic aims to address the deficient OTC enzyme in the livers of individuals with this disease. ARCT-810 has the potential to restore urea cycle activity and prevent metabolic crises that cause urological damage and potentially liberalized strict dietary protein restrictions and improve the quality of life for people living with this condition.

現在轉到我們的早期項目，我將從 ARCT-810 開始。這是我們治療鳥氨酸轉氨甲酰酶缺乏症或 OTC 缺乏症的候選藥物。這項研究性治療旨在解決患有這種疾病的個體肝臟中缺乏的 OTC 酶。 ARCT-810 有可能恢復尿素循環活動並預防導致泌尿系統損傷的代謝危機，並可能放寬嚴格的飲食蛋白質限制並改善患有這種疾病的人的生活質量。

The program utilizes our proprietary LUNAR delivery technology and 1 important attribute of this technology is that the lipids administered are rapidly degraded which we expect will contribute to a favorable safety profile. We are evaluating ARCT-810 and 2 ongoing clinical studies, a Phase Ib study in adults and a multi-dose Phase II study in adolescents and adults with OTC deficiency.

該計劃利用我們專有的 LUNAR 遞送技術，該技術的一個重要特性是所施用的脂質會迅速降解，我們預計這將有助於獲得良好的安全性。我們正在評估 ARCT-810 和 2 項正在進行的臨床研究，一項針對成人的 Ib 期研究和一項針對患有 OTC 缺乏症的青少年和成人的多劑量 II 期研究。

These studies build upon a completed Phase I study that demonstrated a favorable safety profile when dosed up to 0.4 mg per kilogram, the highest dose evaluated in that study. We continue to advance ARCT-810 in the Phase II study. The study will enroll up to 24 adolescents and adults living with OTC deficiency distributed across 2 dose cohorts.

這些研究建立在已完成的 I 期研究的基礎上，該研究表明，當劑量高達 0.4 mg/kg（該研究中評估的最高劑量）時，具有良好的安全性。我們繼續推進 ARCT-810 的 II 期研究。該研究將招募多達 24 名患有 OTC 缺乏症的青少年和成年人，分佈在 2 個劑量組中。

The study has enrolled multiple subjects. We remain on track to report ARCT-810 Phase II interim clinical data later this year. Now moving on to ARCT-032. This is our inhaled messenger RNA therapeutic candidate for cystic fibrosis. With this drug, we are aiming to express fully functional CFTR protein in the lungs of individuals with cystic fibrosis.

該研究招募了多個受試者。我們仍有望在今年晚些時候報告 ARCT-810 II 期中期臨床數據。現在轉到 ARCT-032。這是我們用於治療囊性纖維化的吸入性信使 RNA 候選藥物。使用這種藥物，我們的目標是在囊性纖維化患者的肺部表達功能齊全的 CFTR 蛋白。

Our approach is agnostic to the underlying mutations associated with the disease. And we believe that ARCT-032 could provide benefit across a very wide range of those living with CF, especially type 1 CF and for individuals who are not well served by CFTR modulator therapies.

我們的方法與疾病相關的潛在突變無關。我們相信 ARCT-032 可以為範圍廣泛的 CF 患者帶來益處，尤其是 1 型 CF 以及 CFTR 調節劑療法效果不佳的個人。

We're grateful to have obtained support from the CF Foundation for the advancement of this promising investigational medicine. We also benefit from in valuable scientific collaboration with the experts at the CF Foundation. Previously, we reported encouraging preclinical data, demonstrating successful delivery to the lung in 4 different animal species; mice, rats, ferrets and primates.

我們很高興獲得 CF 基金會的支持，以推動這一有前途的研究藥物的發展。我們還受益於與 CF 基金會專家的寶貴科學合作。此前，我們報告了令人鼓舞的臨床前數據，證明在 4 種不同的動物物種中成功輸送到肺部；小鼠、大鼠、雪貂和靈長類動物。

Notably, our data have shown the ability to deliver mRNA to airway epithelium in the CF Ferret. This is a disease model that produces significant mucus in the airways, similar to patients with CF. Finally, in vitro treatment of bronchial epithelial cells from CF donors with ARCT-032 has demonstrated robust expression of CFTR protein and restoration of chloride current.

值得注意的是，我們的數據顯示了將 mRNA 傳遞到 CF 雪貂氣道上皮細胞的能力。這是一種在氣道中產生大量粘液的疾病模型，類似於 CF 患者。最後，用 ARCT-032 體外處理來自 CF 供體的支氣管上皮細胞已證明 CFTR 蛋白的穩健表達和氯離子電流的恢復。

Supported by these encouraging data, we are now evaluating ARCT-032 at 4 different dose levels in a Phase I study being conducted in New Zealand. We have successfully completed the enrollment of the first 2 cohorts with expectation to complete enrollment of the entire 32 subject study in the second quarter of this year and plan to report study results later this year.

在這些令人鼓舞的數據支持下，我們現在正在新西蘭進行的 I 期研究中評估 4 種不同劑量水平的 ARCT-032。我們已成功完成前 2 個隊列的註冊，預計將在今年第二季度完成全部 32 個學科研究的註冊，併計劃在今年晚些時候報告研究結果。

Arcturus is excited to share our LUNAR-HBV data next month. We have been optimizing our in vivo intravenously dosed gene editing platform for years. Our preclinical gene editing mRNA platform data for hepatitis B virus will be presented on April 27 at the 18th Annual Global Hepatitis Summit Conference in Paris, France. This will be the first opportunity for the scientific community to evaluate the benefits of Arcturus' LUNAR delivery of systemically administered mRNA for gene editing applications.

Arcturus 很高興在下個月分享我們的 LUNAR-HBV 數據。多年來，我們一直在優化我們的體內靜脈內給藥基因編輯平台。我們的乙型肝炎病毒臨床前基因編輯 mRNA 平台數據將於 4 月 27 日在法國巴黎舉行的第 18 屆年度全球肝炎峰會上公佈。這將是科學界第一次評估 Arcturus 的 LUNAR 交付系統管理的 mRNA 用於基因編輯應用的好處。

In this past quarter, we have strengthened our management team. We have brought on Dr. Jurgen Fralick, to be our CMO, our Chief Medical Officer, to provide seasoned leadership over our mRNA therapeutics pipeline and also have brought on board Dr. Igor Smolenov to be our Chief Development Officer, who will lead our Arcturus' clinical development efforts for our promising COVID and seasonal flu self-amplifying mRNA vaccines.

在上個季度，我們加強了管理團隊。我們聘請了 Jurgen Fralick 博士擔任我們的首席營銷官，我們的首席醫療官，以對我們的 mRNA 治療管道提供經驗豐富的領導，並聘請 Igor Smolenov 博士擔任我們的首席開發官，他將領導我們的 Arcturus ' 我們有前途的 COVID 和季節性流感自擴增 mRNA 疫苗的臨床開發工作。

Now Dr. Fralick has broad and successful experience in the field of rare diseases, including OTC deficiency and cystic fibrosis. He will assuredly increase our likelihood of success as Arcturus initiates and navigates through late-stage clinical trials for our rare disease therapeutic programs. He has 3 decades of broad and late-stage therapeutic clinical development experience at Genentech, Quintiles, BMS, Ipsen, Vertex and Genevant. Jürgen completed Medical School at the University of Wuerzberg in Germany, -- he is a Diplomat of the American Board of Clinical Pharmacology and holds a dual executive MBA from Zurich, Switzerland and the State University of New York at Albany.

現在，Fralick 博士在罕見病領域擁有廣泛而成功的經驗，包括 OTC 缺乏症和囊性纖維化。他肯定會增加我們成功的可能性，因為 Arcturus 為我們的罕見疾病治療計劃啟動並完成了後期臨床試驗。他在 Genentech、Quintiles、BMS、Ipsen、Vertex 和 Genevant 擁有 3 年的廣泛和後期治療臨床開發經驗。 Jürgen 在德國維爾茨堡大學完成了醫學院學業，他是美國臨床藥理學委員會的外交官，並擁有瑞士蘇黎世和紐約州立大學奧爾巴尼分校的雙行政工商管理碩士學位。

Jürgen has been directly involved in successful global marketing authorizations of drugs in the U.S., Canada, the European Union, Switzerland and Australia. Since 2011, he's been involved in early and late-stage development of CF therapeutics, including the approval of KALYDECO and clinical development planning for other CFTR modulators.

Jürgen 直接參與了藥物在美國、加拿大、歐盟、瑞士和澳大利亞的成功全球營銷授權。自 2011 年以來，他一直參與 CF 療法的早期和後期開發，包括 KALYDECO 的批准和其他 CFTR 調節劑的臨床開發規劃。

He has seasoned experience in Phase I, II and III trials with inhaled therapeutics in patients with CF to treat chronic lung infection. We are fortunate to have Dr. Jurgen Fralick, join our management team as our Chief Medical Officer.

他在 CF 患者吸入療法治療慢性肺部感染的 I、II 和 III 期試驗中擁有豐富的經驗。我們很幸運有 Jurgen Fralick 博士加入我們的管理團隊，擔任我們的首席醫療官。

Now moving on to introduce our Chief Development Officer of Vaccines, Dr. Igor Smolenov has a strong record of successfully developing vaccines all the way through approval. He will help our vaccine team and our partnership with CSL, get our COVID and flu programs to this next level, and we're excited about that.

現在繼續介紹我們的疫苗首席開發官，Igor Smolenov 博士在成功開發疫苗並通過審批方面有著良好的記錄。他將幫助我們的疫苗團隊以及我們與 CSL 的合作夥伴關係，使我們的 COVID 和流感計劃更上一層樓，我們對此感到很興奮。

Dr. Smolenov is a recognized leader in clinical development with a proven record of accomplishment in biotech and large pharmaceutical companies. He contributed to the successful development and licensure of several innovative vaccines. Before joining Arcturus, Dr. Smolenov was the Executive Vice President at Clover Pharmaceuticals. That's where he built a strong team that was able to rapidly generate pivotal clinical data, leading to a COVID-19 vaccine authorization and product launch there.

Smolenov 博士是臨床開發領域公認的領導者，在生物技術和大型製藥公司取得了公認的成就。他為多種創新疫苗的成功開發和許可做出了貢獻。在加入 Arcturus 之前，Smolenov 博士是 Clover Pharmaceuticals 的執行副總裁。在那裡，他建立了一支強大的團隊，能夠快速生成關鍵的臨床數據，從而獲得 COVID-19 疫苗授權並在那裡推出產品。

Before that, Dr. Smolenov served as a therapeutic area head, leading the development of several seasonal flu vaccines at CSL Seqirus. Igor was the Head of Clinical Development at Moderna, managing the initiation of the first clinical trials of messenger RNA vaccines in humans. At Novartis Vaccines, Dr. Smolenov contributed to the development and global licensure of multiple vaccines there as well.

在此之前，Smolenov 博士擔任治療領域負責人，在 CSL Seqirus 領導了幾種季節性流感疫苗的開發。 Igor 是 Moderna 的臨床開發主管，負責啟動人類信使 RNA 疫苗的首次臨床試驗。在 Novartis Vaccines，Smolenov 博士也為那裡的多種疫苗的開發和全球許可做出了貢獻。

Igor graduated from Volgograd State Medical University in Russia, where he holds an MD, a PhD and a doctor of science degrees from this university. He's the author of more than 50 publications in peer-reviewed journals in clinical pharmacology, infectious disease and vaccine development. We are indeed fortunate to have Dr. Igor Smolenov join our team here at Arcturus as our CEO overseeing our vaccine franchise. I will now pass the call on to Andy Sassine, our CFO, to provide financial updates.

Igor 畢業於俄羅斯伏爾加格勒國立醫科大學，並在該大學獲得醫學博士、博士學位和理學博士學位。他在臨床藥理學、傳染病和疫苗開發領域的同行評審期刊上發表了 50 多篇文章。我們確實很幸運，伊戈爾·斯莫列諾夫 (Igor Smolenov) 博士加入了我們在 Arcturus 的團隊，擔任我們的首席執行官，負責監督我們的疫苗特許經營權。我現在將電話轉給我們的首席財務官 Andy Sassine，以提供財務更新。

Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the fourth quarter and fiscal year 2022 and provides a summary and analysis of year-over-year and sequential financial performance. Please also reference our Form 10-K for more details on the financial performance.

謝謝你，喬，大家下午好。今天早些時候發布的新聞稿包括第四季度和 2022 財年的財務報表，並提供了對同比和連續財務業績的總結和分析。另請參閱我們的 10-K 表格，了解有關財務業績的更多詳細信息。

I'll begin with the CSL agreement. Arcturus received a $200 million upfront payment that was received in the fourth quarter of 2022. Additionally, in March 2023, Arcturus achieved development milestones primarily associated with nominating next-generation candidate for COVID-19 and seasonal flu programs resulting in $90 million invoiced to CSL.

我將從 CSL 協議開始。 Arcturus 收到了 2022 年第四季度收到的 2 億美元預付款。此外，在 2023 年 3 月，Arcturus 實現了主要與提名下一代 COVID-19 候選者和季節性流感計劃相關的發展里程碑，從而向 CSL 開具了 9000 萬美元的發票.

We are excited to continue working on these programs under the guidance and leadership of our partner, CSL. Our CSL collaboration is a 40-60 profit sharing agreement related to COVID-19 vaccine product. With respect to program costs related to the bivalent COVID-19 vaccine, we expect that future anticipated milestones will cover all related expenses going forward.

我們很高興能在我們的合作夥伴 CSL 的指導和領導下繼續開展這些計劃。我們的 CSL 合作是一項與 COVID-19 疫苗產品相關的 40-60 利潤分享協議。關於與二價 COVID-19 疫苗相關的計劃成本，我們預計未來預期的里程碑將涵蓋未來的所有相關費用。

Additionally, the program cost for the seasonal flu candidate will be reimbursed in full on an ongoing basis. CSL can apply a $37.5 million R&D credit to be used within the next 5 years against cost incurred on the flu and 3 other respiratory disease vaccines.

此外，季節性流感候選人的計劃費用將持續全額報銷。 CSL 可以申請 3750 萬美元的研發信貸，以在未來 5 年內用於抵消流感和其他 3 種呼吸道疾病疫苗產生的費用。

As you heard earlier, we are excited that Meiji completed enrollment during the first quarter of 2023 for the Phase III COVID-19 booster trial of ARCT-154 in Japan. Meiji is responsible for all related clinical, regulatory, development and manufacturing expenses for the ARCT-154 booster vaccine.

正如您之前所聽到的，我們很高興明治在 2023 年第一季度完成了日本 ARCT-154 III 期 COVID-19助推器試驗的註冊。明治負責 ARCT-154 加強疫苗的所有相關臨床、監管、開發和製造費用。

Our manufacturing loan with the Singapore government, which had a principal and interest balance of $50.4 million as of December 31, 2022 was renegotiated in March 2023, which resulted in Arcturus paying back $17.1 million and the remaining $33.3 million being forgiven. As a result, Arcturus has no further loan obligation payable to Singapore.

截至 2022 年 12 月 31 日，我們與新加坡政府的製造貸款本金和利息餘額為 5040 萬美元，該貸款於 2023 年 3 月重新談判，導致 Arcturus 償還 1710 萬美元，其餘 3330 萬美元被免除。因此，Arcturus 沒有進一步向新加坡支付的貸款義務。

On the treasury side, in March 2023, we paid off the remaining loan with Western Alliance Bank which had a balance of $10 million as of December 31, 2022, and we entered into a new banking relationship with Wells Fargo. Based on the substantial funding provided by the CSL collaboration, we expect Arcturus to be in a very strong financial position in the next few years.

在資金方面，2023 年 3 月，我們還清了截至 2022 年 12 月 31 日餘額為 1000 萬美元的西部聯盟銀行的剩餘貸款，並與富國銀行建立了新的銀行業務關係。基於 CSL 合作提供的大量資金，我們預計 Arcturus 在未來幾年將處於非常強勁的財務狀況。

Our cash runway now extends to the beginning of 2026 based on our current pipeline and assuming no milestones or revenues from any commercial product sales. I will now provide a quick summary of our financial results for the fourth quarter of 2022. We reported revenues of $160.3 million for the fourth quarter compared to revenues of $5.8 million in the fourth quarter of 2021. The increase in revenue was predominantly driven by the license portion of the upfront payment from the CSL transaction.

根據我們目前的管道，我們的現金跑道現在延伸到 2026 年初，並假設沒有任何商業產品銷售的里程碑或收入。我現在將簡要介紹我們 2022 年第四季度的財務業績。我們報告第四季度的收入為 1.603 億美元，而 2021 年第四季度的收入為 580 萬美元。收入的增長主要是由CSL 交易預付款的許可部分。

We reported total operating expenses of $38.8 million during the fourth quarter of 2022 compared to operating expenses of $43.4 million in the fourth quarter of '21. The decline in operating expenses was primarily due to lower COVID-19-related manufacturing and clinical-related expenses.

我們報告的 2022 年第四季度總運營費用為 3880 萬美元，而 2021 年第四季度的運營費用為 4340 萬美元。運營費用的下降主要是由於與 COVID-19相關的製造和臨床相關費用減少。

Finally, we reported a net income of approximately $117.3 million or $4.43 per diluted share during the fourth quarter of 2022 compared to a net loss of $38.7 million or $1.47 per diluted share during the fourth quarter of 2021. I am happy to report for the first time in the history of the company we reported net income of $9.3 million for the fiscal year ended 2022.

最後，我們報告了 2022 年第四季度的淨收入約為 1.173 億美元或每股攤薄收益 4.43 美元，而 2021 年第四季度的淨虧損為 3870 萬美元或每股攤薄收益 1.47 美元。我很高興報告第一個在公司歷史上，我們報告稱截至 2022 財年的淨收入為 930 萬美元。

In summary, we believe that the company is in a strong financial position and has the resources needed to achieve multiple near-term value-creating milestones for the vaccine and therapeutic programs over the next 12 months.

總而言之，我們認為該公司財務狀況良好，擁有在未來 12 個月內實現疫苗和治療項目的多個近期價值創造里程碑所需的資源。

I will now pass the call back to Joe.

我現在將電話轉回給喬。

Thanks, Andy. It's been a productive quarter. We hit the ground running with CSL, as indicated by meaningful early milestones being achieved in the partnership. We made measurable progress in each of our clinical programs, which has put us in a position to potentially file our first NDA in Japan and collect meaningful clinical data in 2023 for each one of our pipeline programs. This will showcase the intramuscular, intravenous and inhaled applications of our proprietary mRNA and delivery technologies.

謝謝，安迪。這是一個富有成效的季度。正如在合作夥伴關係中實現的有意義的早期里程碑所表明的那樣，我們與 CSL 一起打響了基礎。我們在每個臨床項目中都取得了可衡量的進展，這使我們有可能在日本提交我們的第一個 NDA，並在 2023 年為我們的每個管道項目收集有意義的臨床數據。這將展示我們專有的 mRNA 和遞送技術在肌內、靜脈內和吸入方面的應用。

And we've also strengthened our management team and look forward to many of you meeting them over the next -- the remainder of the year. So with that, we would like to turn the time over to the operator for questions.

我們還加強了我們的管理團隊，並期待你們中的許多人在接下來的時間——今年餘下的時間裡與他們會面。因此，我們想把時間交給接線員提問。

(Operator Instructions) First question comes from the line of Seamus Fernandez with Guggenheim.

（操作員說明）第一個問題來自古根海姆的 Seamus Fernandez。

So my first question is actually on the Meiji trial. It sounds like the team there has made a lot of progress enrolling patients and we're almost on the cusp of actually getting the clinical data. I was just hoping that the team could comment on what your hopes or expectations are for those data relative to Comirnaty? And if there will be follow-up data because I believe there has been in the past some suggestion of greater durability with the self-amplifying RNA as a potential advantage over just a standard modified mRNA.

所以我的第一個問題實際上是關於明治審判的。聽起來那裡的團隊在招募患者方面取得了很大進展，我們幾乎快要真正獲得臨床數據了。我只是希望團隊可以評論您對與 Comirnaty 相關的這些數據的希望或期望是什麼？如果會有後續數據，因為我相信過去有一些建議認為自擴增 RNA 具有比標準修飾 mRNA 更高的潛在優勢。

And then the second question, just really wanted to get a better sense if you are willing to share the dosing regimen in a little bit more detail and the number of patients that have been dosed so far in the OTC study?

然後是第二個問題，如果您願意更詳細地分享給藥方案以及迄今為止在 OTC 研究中已經給藥的患者人數，真的想更好地了解嗎？

Thanks, Seamus. Well, with respect to your first question, the primary objective of that trial is to establish noninferiority with respect to the immunogenicity data. One of the key sets of immunogenicity data is that 1-month blood data that's been drawn already. So you're correct in your assessment that we're collecting data as we speak, that's very relevant to the upcoming potential new drug application in Japan.

謝謝，西默斯。那麼，關於你的第一個問題，該試驗的主要目的是確定免疫原性數據的非劣效性。一組關鍵的免疫原性數據是已經抽取的 1 個月血液數據。所以你的評估是正確的，我們正在收集數據，這與日本即將到來的潛在新藥申請非常相關。

So we want to make sure that, that immunogenicity data is included in the application. With respect to your durability inference, yes, no doubt, we will be tracking that in parallel. But that durability data is not a prerequisite to establishing approval with the PMDA approval in Japan. It will be an add-on and just strengthen our commercial business case if we're fortunate to get commercialized this year.

所以我們要確保，免疫原性數據包含在應用程序中。關於您的耐久性推斷，是的，毫無疑問，我們將同時跟踪它。但耐久性數據並不是獲得日本 PMDA 批准的先決條件。如果我們有幸在今年實現商業化，這將是一個附加組件，只會加強我們的商業業務案例。

Yes. And then the -- with respect to the second question, all we've indicated and guided there with respect to OTC is that we -- for the first time, we've informed, we've communicated externally that we have now enrolled multiple patients. We cannot give any more specifics than that. And then with respect to guidance, we want to be clear that we're still on track for sharing Phase II data later this year.

是的。然後--關於第二個問題，我們在 OTC 方面所指出和指導的是，我們--第一次，我們已經通知，我們已經與外部溝通，我們現在已經註冊了多個患者。我們不能提供比這更多的細節。然後關於指導，我們想明確表示我們仍在按計劃在今年晚些時候共享第二階段數據。

Joe, if you don't mind, can I just clarify enrolled patients? Or have you started dosing patients officially?

喬，如果你不介意的話，我可以澄清一下登記的患者嗎？或者你已經開始正式給病人用藥了嗎？

Yes, enrolled means that I define as dosing, correct. So whenever I mentioned the word enrollment in this context, it's past screening, they have been dosed, correct. .

是的，註冊意味著我定義為劑量，正確。因此，每當我在這種情況下提到“註冊”這個詞時，都是經過篩選的，他們已經接受了劑量，正確的。 .

Seamus, just 1 other point is that even in the early the first dosing, we are expecting some pharmacological activity because it is a dose level where we've seen pharmacological effect in preclinical models.

Seamus，另外一點是，即使在第一次給藥的早期，我們也期待一些藥理活性，因為這是我們在臨床前模型中看到藥理作用的劑量水平。

Our next question comes from the line of Yanan Zhu with Wells Fargo.

我們的下一個問題來自 Yanan Zhu 與 Wells Fargo 的對話。

Great. Congrats on the progress. A few questions. On the Japan COVID study, could you talk about the -- what might be the noninferiority margin for the primary analysis? And have you talked about the potential economics from Japanese regulatory approval?

偉大的。祝賀進步。幾個問題。關於日本 COVID 研究，您能否談談——主要分析的非劣效性界限可能是多少？您是否談到了日本監管機構批准的潛在經濟效益？

Well, I want to make sure I understand your question. With respect to the Phase III trial in Japan, I know that it's been properly powered to achieve statistical relevance with respect to a noninferior endpoint. So there's no concerns there with respect to the margins required. Numerical superiority will obviously be observed, but statistical superiority, we'll have to collect the data to understand that. With respect to your second question, which was on -- I can pass it along to Andy.

好吧，我想確保我理解你的問題。關於日本的 III 期試驗，我知道它已得到適當的支持以實現與非劣效終點相關的統計相關性。因此，無需擔心所需的保證金。顯然會觀察到數值優勢，但統計優勢，我們必須收集數據才能理解。關於你的第二個問題，我可以將它傳遞給 Andy。

Yes. No, thank you for the question. Unfortunately, we don't provide guidance with respect to economics. And when we do have that available, we will share with the market what the economics are for CSL, Meiji and ourselves going forward. So thanks for the question.

是的。不，謝謝你的提問。不幸的是，我們不提供有關經濟學的指導。當我們確實擁有這些資源時，我們將與市場分享 CSL、Meiji 和我們自己未來的經濟狀況。所以謝謝你的問題。

Got it. And then a couple of questions on OTC deficiency. In terms of data later this year, you mentioned a subset of patients. Would we see 1 or both cohorts of data? And also what would define success for that readout?

知道了。然後是關於場外交易不足的幾個問題。關於今年晚些時候的數據，您提到了一部分患者。我們會看到一組或兩組數據嗎？還有什麼可以定義該讀數的成功？

Sure. So the success is biological proof of concept, and that's being defined by biomarker changes being observed in this patient population. So the biomarkers include ammonia and orotic acid in our ammonia in the blood, orotic acid in the urine. Urea genesis in will be measured. Other amino assets will be also measured for and the OTC enzyme itself will be measured in the blood through unvalidated assay.

當然。因此，成功是概念的生物學證明，這是通過在該患者群體中觀察到的生物標誌物變化來定義的。因此，生物標誌物包括我們血液中氨中的氨和乳清酸，以及尿液中的乳清酸。將測量尿素生成。其他氨基資產也將被測量，OTC 酶本身將通過未經驗證的化驗在血液中測量。

So several biomarkers will be measured. And so when we indicate biological proof of concept, we mean being able to measure or determine changes in those biomarkers because of the therapeutic. With respect -- what was the other question?

因此，將測量幾種生物標誌物。因此，當我們指出概念的生物學證明時，我們的意思是能夠測量或確定這些生物標誌物因治療而發生的變化。恕我直言——另一個問題是什麼？

Would we see 1 or both cohorts of patients?

我們會看到一組還是兩組患者？

That depends on the rate of enrollment. We're recruiting up to 24 subjects in this trial and 12 of them are at 1 particular dose and 12 were at another dose. And this is placebo controlled. So it's a 9:3, 3:1 ratio at each of those cohorts. So if the rate of enrollment exceeds 12, then yes, we'll be able to provide those observations.

這取決於入學率。我們在該試驗中招募了多達 24 名受試者，其中 12 人服用一種特定劑量，12 人服用另一種劑量。這是安慰劑對照的。因此，每個隊列的比例為 9:3、3:1。因此，如果入學率超過 12，那麼是的，我們將能夠提供這些觀察結果。

Great. Lastly, on the cystic fibrosis program with data later this year. Just wondering what -- for this healthy volunteer study, what would be the most meaningful readout that we should watch out for? And how do you determine the dose to be used in cystic fibrosis patients afterwards?

偉大的。最後，關於今年晚些時候有數據的囊性纖維化計劃。只是想知道 - 對於這項健康的志願者研究，我們應該注意的最有意義的讀數是什麼？您如何確定囊性纖維化患者之後使用的劑量？

Right. So this is the most meaningful exercise here with these 4 doses being evaluated in these early subjects in Phase I. It's just ascertaining safety and tolerability of the dosing regimen itself. This is an inhaled therapeutic. So we're going to be able to quickly evaluate the maximum tolerated dosing for example, see how long can a person enable this therapeutic for. And so that will be the most interesting data that could come out of this.

正確的。所以這是最有意義的練習，在第一階段的這些早期受試者中評估了這 4 種劑量。它只是確定給藥方案本身的安全性和耐受性。這是一種吸入療法。因此，我們將能夠快速評估最大耐受劑量，例如，看看一個人可以使用這種療法多長時間。因此，這將是由此產生的最有趣的數據。

Yes, this is Pad. And based on our Phase I data, obviously, we'll be looking at the lowest dose and the top dose. And when we decide to -- when we go into Phase II, we can probably eliminate some of the lower doses, and we'll pick a dose where we feel comfortable with, that has a good safety margin to start with.

是的，這是帕德。根據我們的第一階段數據，顯然，我們將研究最低劑量和最高劑量。當我們決定 - 當我們進入第二階段時，我們可能會取消一些較低的劑量，我們會選擇一個我們覺得舒服的劑量，開始時有一個很好的安全邊際。

Our next question comes from the line of Yigal Nochomovitz with Citi.

我們的下一個問題來自花旗的 Yigal Nochomovitz。

This is Ashu Mubarack on for Yigal. On the OTC program, you had some earlier comments on enrollment and how that's going. Can you comment at all on the rate of enrollment in particular, site activation and if there are still outstanding challenges there or if was more or less problem solved? And in terms of the OTC data itself, you're planning on sharing. Can you comment at all on your expectations for kinetics of response, meaning as in how long do you need to dose and follow these patients before accumulating enough response data that would be meaningful enough to share?

這是 Yigal 的 Ashu Mubarack。關於 OTC 計劃，您之前對註冊及其進展情況有一些評論。您能否評論一下註冊率，特別是網站激活率，以及那裡是否仍然存在突出的挑戰，或者是否或多或少地解決了問題？就場外交易數據本身而言，您正計劃共享。您能否評論一下您對反應動力學的期望，也就是說，在積累足夠有意義的反應數據以供分享之前，您需要對這些患者進行給藥和隨訪多長時間？

Sure. So I can update the market that we have now onboarded 9 active sites for OTC deficiency. The bulk of that effort was last year. This is the year where we've initiated enrollment officially. So with respect to the pace of enrollment, it's nothing that is out of the ordinary for a rare liver disease in Europe. So that's the only comment I can provide there. All we've disclosed is multiple patients being enrolled so far.

當然。因此，我可以更新市場信息，我們現在已經加入了 9 個針對 OTC 缺陷的活躍站點。大部分努力是在去年進行的。今年是我們正式開始招生的一年。因此，就註冊速度而言，對於歐洲罕見的肝病來說，這沒什麼不尋常的。這是我能提供的唯一評論。到目前為止，我們所披露的是多名患者正在登記。

With respect to the kinetics, it's helpful to understand that this is a 6 administration trial. So these doses are separated by 2 weeks. So there's 6 administrations. And what we've seen preclinically is that OTC is additive in our preclinical animal studies. So we may see this in humans as well. So that with respect to kinetics, we are collecting blood draws after each administration over these half a dozen doses.

關於動力學，了解這是一個 6 次給藥試驗會很有幫助。所以這些劑量間隔 2 週。所以有 6 個主管部門。我們在臨床前看到的是，OTC 在我們的臨床前動物研究中是附加的。所以我們也可能在人類身上看到這一點。因此，就動力學而言，我們在這六個劑量的每次給藥後收集血液抽取。

Yes. Again, this is Pad. Just to point out that we're the first protein replacement therapeutic that's going after this indication and specifically for protein replacement using mRNA. So there's a lot of unpaved road that we're trying to tackle. What We envision, of course, that we could see something in the first few doses. And if we do -- because of that, we are measuring a handful of biomarkers. So we hope that we see something very soon, and we'll report on that.

是的。再一次，這是帕德。只是要指出，我們是第一個在這個適應症之後進行的蛋白質替代療法，特別是使用 mRNA 進行蛋白質替代。因此，我們正在努力解決許多未鋪砌的道路。當然，我們設想的是我們可以在前幾劑中看到一些東西。如果我們這樣做 - 因此，我們正在測量少數生物標誌物。所以我們希望我們很快就能看到一些東西，我們會就此進行報告。

Got it. That's very helpful. And if I could ask 1 more on the cystic fibrosis program. Do you think it's possible we could get some initial healthy volunteer data this calendar year? Or is that you think that's more likely to be a 2024 event? Maybe once you have that data in hand, how do you think you can pivot into treating actual cystic fibrosis patients?

知道了。這很有幫助。如果我能再問 1 個關於囊性纖維化計劃的問題。你認為我們有可能在這個日曆年獲得一些初步的健康志願者數據嗎？還是您認為這更有可能成為 2024 年的活動？也許一旦你掌握了這些數據，你認為你如何才能轉向治療實際的囊性纖維化患者？

Yes. The study is being conducted in New Zealand, the Phase I study for CF because we've already dosed a pair of cohorts, there may be some initial feedback from, and we haven't had any serious or severe adverse events, right? We just have to report on that. So after the first survey after the first couple of cohorts, it does present the potential opportunity to amend Phase I to add CF patients. .

是的。這項研究是在新西蘭進行的，這是 CF 的 I 期研究，因為我們已經對兩個隊列進行了給藥，可能會有一些初步反饋，而且我們沒有發生任何嚴重或嚴重的不良事件，對嗎？我們只需要就此進行報告。因此，在第一批隊列之後的第一次調查之後，它確實提供了修改第一階段以增加 CF 患者的潛在機會。 .

But whether we add CF patients to the Phase I trial itself or quickly pivot to a more traditional Phase II regulatory process is yet to be determined and communicated.

但是，我們是將 CF 患者添加到 I 期試驗本身，還是迅速轉向更傳統的 II 期監管流程，還有待確定和溝通。

Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald.

我們的下一個問題來自 Pete Stavropoulos 與 Cantor Fitzgerald 的對話。

So I have 1 on 810, the OTC deficiency program. What type of patients are you enrolling? Can you speak to their baseline characteristics? Are you kind of enrolling patients are stable on stable background meds? And are they controlled uncontrolled? And can you speculate in which type of patients you may be able to see the most pronounced effects in?

所以我在 810 上有 1 個，OTC 缺陷程序。您要招募什麼類型的患者？你能談談他們的基線特徵嗎？您是否招募了穩定背景藥物的穩定患者？他們是不受控制的嗎？您能否推測在哪種類型的患者中您可能會看到最顯著的效果？

Yes. These are stable adult and adolescents subjects. That will be the initial focus. So both adults and adolescents in the European Phase II multiple ascending dose trial. So I can comment on that. With respect to the other, and what was the other aspect of your question?

是的。這些是穩定的成人和青少年受試者。這將是最初的重點。因此，歐洲 II 期多次遞增劑量試驗中的成人和青少年。所以我可以對此發表評論。關於另一個，你的問題的另一個方面是什麼？

Can you speculate on which type of patients you may actually see the most pronounced effect?

您能推測出您實際上可能看到哪種類型的患者效果最顯著嗎？

Okay. Well, I think this therapeutic has the opportunity to have a biological impact on every patient injected. However, if they are already on ammonia scavengers, for example, the other biomarkers will be more meaningful, like urea genesis and OTC itself. But if they are not on ammonia scavengers then, of course, ammonia will be looked at orotic acid and other amino acids are going to be investigated on, so the collective body of data should be sufficient to negotiate the regulatory path efficiently with regulatory agencies.

好的。好吧，我認為這種療法有機會對每位注射的患者產生生物學影響。然而，如果它們已經在氨清除劑上，例如，其他生物標誌物將更有意義，如尿素生成和 OTC 本身。但是，如果他們不使用氨清除劑，那麼當然，氨將被研究乳清酸，其他氨基酸將被研究，因此數據集應該足以與監管機構有效地協商監管路徑。

Yes, I have a couple of questions. So if you can give a sense of how many subjects have gone through the full dosing cycle in the Phase II MAD study? And are you -- is there like a safety look built in by, let's say, the BsmB?

是的，我有幾個問題。那麼，您能否了解在第二階段 MAD 研究中有多少受試者經歷了完整的給藥週期？你是不是——比方說，BsmB 內置了安全外觀？

Yes, there's always safety checkpoints, but we've already got approval to proceed in a multiple ascending dose for 6 administrations, right? Always communicated as multiple subjects. But if every 2 weeks, there's another administration. So you can make your assumptions based on that, that there's enrolled subjects that if they continued on in the study, of course, they would have multiple administrations so far.

是的，總是有安全檢查點，但我們已經獲准在 6 次給藥中進行多次遞增劑量，對嗎？總是作為多個主題進行交流。但如果每 2 週，就會有另一次管理。因此，您可以在此基礎上做出假設，即有一些受試者如果繼續參加研究，當然，到目前為止，他們將接受多次管理。

Okay. And moving on to 032. So congratulations on that. The enrollment seems to be going well. But just have -- I know you briefly mentioned preclinical data in your prepared remarks. But if you can go into a little bit more detail, perhaps, Pad, what from the preclinical data sort of enhance our conviction to move into the human studies? And specifically, can you discuss the predictive value of the ferret model? And how phenotypically similar? Is it to see patients, recapitulate human disease in the lungs? And has it been validated through other therapeutic agents?

好的。然後轉到 032。祝賀你。招生似乎進展順利。但只是 - 我知道你在準備好的發言中簡要提到了臨床前數據。但是，如果你能更詳細一點，也許，帕德，從臨床前數據中可以看出什麼增強了我們進入人體研究的信念？具體來說，你能談談雪貂模型的預測價值嗎？表型有多相似？是看病人，在肺部重演人類疾病嗎？它是否通過其他治療藥物得到驗證？

Yes. The CF Ferret model is relatively new. It's an exciting model that the CF Foundation and many others are recommending companies to utilize because it's very likely more representative of the human condition because of the mucus that's generated in the lungs and the CF Ferret model. The key -- so it's difficult to speculate or confirm that this is a validated predictive model, but I think it's very logical to suggest that it's more representative of the human condition because of the additional mucus in the lungs, I think that is a safe assumption.

是的。 CF Ferret 模型相對較新。這是一個令人興奮的模型，CF 基金會和許多其他機構正在推薦公司使用，因為肺部產生的粘液和 CF 雪貂模型很可能更能代表人類狀況。關鍵——所以很難推測或確認這是一個經過驗證的預測模型，但我認為由於肺部有額外的粘液，建議它更能代表人類狀況是非常合乎邏輯的，我認為這是安全的假設。

I would like to just point out that our approach has been different from previous approaches that we properly modify and also purify our messenger RNA molecule utilizing the Arcturus proprietary technology. This is the first time an inhaled messenger RNA therapeutic for CF has entered the clinic utilizing the LUNAR technology. This technology has been highly optimized for bronchial epithelial cell delivery and been optimized to survive the mucus environment and optimized for inhalation and aerosolization processes.

我只想指出，我們的方法不同於以前的方法，我們使用 Arcturus 專有技術適當修改和純化我們的信使 RNA 分子。這是 CF 的吸入性信使 RNA 療法首次利用 LUNAR 技術進入臨床。該技術已針對支氣管上皮細胞輸送進行了高度優化，並針對粘液環境進行了優化，並針對吸入和霧化過程進行了優化。

And then finally, we also note that this has also been uniquely optimized. The CFTR construct itself to increase functional activity. So there's a lot of differences in this therapeutic than what's been tried before. So we look at the CF ferret model as indicative, very meaningful because we just don't see a lot of folks or companies or therapeutics being showcased in this specific model. So I think it could potentially be very meaningful.

最後，我們還注意到這也得到了獨特的優化。 CFTR 構建自身以增加功能活動。因此，這種療法與以前嘗試過的療法有很多不同之處。所以我們將 CF 雪貂模型視為指示性的，非常有意義，因為我們只是沒有看到很多人、公司或療法在這個特定模型中被展示。所以我認為它可能非常有意義。

That is all the time we have for questions at this time. I'd like to hand the call back to Joseph Payne for closing remarks.

這就是我們目前所有的提問時間。我想將電話轉回 Joseph Payne 以作結束語。

Thanks. Thanks to everybody. So let me -- thanks for participating on the call. If there's any remaining questions, please reach out to the team, and we'll get back to you right away and bye for now.

謝謝。謝謝大家。所以讓我 - 感謝您參加電話會議。如果還有任何問題，請聯繫團隊，我們會立即回复您，暫時再見。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

女士們，先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路，度過美好的一天。