Arcturus Therapeutics Holdings Inc (ARCT) 2024 Q3 法說會逐字稿

(Operator Instructions)

（操作員說明）

Good day, everyone and welcome to today's Arcturus Therapeutics third-quarter 2024 earnings conference call. (Operator Instructions) Please note this call may be recorded, and I will be standing by if you should need any assistance.

大家好，歡迎參加今天的 Arcturus Therapeutics 2024 年第三季財報電話會議。（操作員說明）請注意，此通話可能會被錄音，如果您需要任何協助，我將隨時待命。

It is now my pleasure to turn the conference over to Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. Please go ahead.

現在我很高興將會議交給副總裁兼投資者關係、公共關係和行銷主管 Neda Safarzadeh。請繼續。

Thank you, operator. Good afternoon and welcome to Arcturus Therapeutics quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO; and Andy Sassine, our CFO; Dr Pad Chivukula, our CSO and COO will join them for the Q&A station.

謝謝你，接線生。下午好，歡迎來到 Arcturus Therapeutics 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執行長 Joe Payne 主持；和我們的財務長安迪·薩辛 (Andy Sassine)；我們的 CSO 和 COO Pad Chivukula 博士將與他們一起參加問答站。

Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts or forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

在開始之前，我想提醒大家，本次電話會議中所做的有關事項的陳述不屬於 1995 年《私人證券訴訟改革法案》安全港條款中的歷史事實或前瞻性陳述。

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 the statement.

前瞻性陳述並不保證業績。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、績效和成就與聲明中明示或暗示的結果、績效和成就有重大差異。

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 most recent form 10-K and in subsequent filings with the SEC. In addition, any forward-looking statements presents our views only as of the date, such as statements are made. Arcturus specifically disclaims any obligation to update such statements.

請參閱今天稍早發布的公司新聞稿中的前瞻性聲明免責聲明，以及我們最新的 10-K 表格和隨後向 SEC 提交的文件中的風險因素部分。此外，任何前瞻性陳述僅代表我們截至目前為止的觀點，例如所做的陳述。Arcturus 特別聲明不承擔更新此類聲明的義務。

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

現在，我將把電話轉給喬。

Thank you, Neda. It's good to be with you again everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks with an update on progress with our vaccine franchise led by KOSTAIVE, our self-amplifying mRNA COVID-19 vaccine. We're thrilled about our recent commercial launch of KOSTAIVE in Japan.

謝謝你，內達。很高興能再次和大家在一起。我們期待今天在季度投資者電話會議上提供最新消息。我將首先介紹由 KOSTAIVE 領導的疫苗系列的最新進展，KOSTAIVE 是我們的自放大 mRNA COVID-19 疫苗。我們對最近在日本商業推出 KOSTAIVE 感到非常興奮。

Last month, members of our senior management team including myself had the wonderful opportunity to travel to Japan to be vaccinated with KOSTAIVE in Tokyo. In addition to our team from Arcturus, we shared this experience with senior management from Meiji CSL and ARCALIS. As you can imagine, it was an experience our team will never forget.

上個月，包括我在內的我們的高階管理團隊成員有幸前往日本東京接種 KOSTAIVE 疫苗。除了 Arcturus 的團隊之外，我們還與 Meiji CSL 和 ARCALIS 的高階管理層分享了這項經驗。正如您可以想像的那樣，這是我們團隊永遠不會忘記的經歷。

In connection with the first sale of our COVID-19 vaccine, Arcturus received a $25 million commercial milestone. On the regulatory front, CSL secures partner in Japan, Meiji Seika Pharma announced earlier this year that they submitted a partial change application for an amendment to the manufacturing and marketing approval of KOSTAIVE to include domestic manufacturing sites in Japan, including ARCALIS. And ARCALIS is Arcturus's manufacturing joint venture in Japan.

隨著我們的 COVID-19 疫苗的首次銷售，Arcturus 獲得了 2500 萬美元的商業里程碑。在監管方面，CSL 在日本找到了合作夥伴，Meiji Seika Pharma 今年稍早宣布，他們提交了一份部分變更申請，要求修訂 KOSTAIVE 的製造和行銷批准，以包括日本國內的生產基地，包括 ARCALIS。ARCALIS 是 Arcturus 在日本的製造合資企業。

When approved, this will allow for Meiji Seika Pharma to begin selling domestically produced KOSTAIVE this season. The European Medicine Agency continues to review the KOSTAIVE marketing authorization application, I've been impressed with how our team has worked diligently with the agency as they reviewed the first potential self-amplifying mRNA product in Europe. The process is near completion with the CHMP opinion expected next month.

一旦獲得批准，明治精化製藥公司將可以在本季開始銷售國產 KOSTAIVE。歐洲藥品管理局繼續審查 KOSTAIVE 行銷授權申請，我們的團隊在審查歐洲第一個潛在的自我擴增 mRNA 產品時與該機構的努力合作給我留下了深刻的印象。該過程已接近完成，預計下個月將獲得 CHMP 意見。

As we look forward to achieving marketing approval in the US, we plan to file BLA for KOSTAIVE in the first half of next year which will be supported by positive results from multiple Phase 3 studies. We continue to collect meaningful clinical data for our proprietary next generation STARR mRNA platform.

由於我們期待在美國獲得上市批准，我們計劃在明年上半年為 KOSTAIVE 提交 BLA，這將得到多項 3 期研究積極結果的支持。我們繼續為我們專有的下一代 STARR mRNA 平台收集有意義的臨床數據。

The company announced today another set of positive Phase 3 results where an ARCT-2303, this is the [monovalent XBB] variant derivative of KOSTAIVE, met all four primary study objectives and key secondary objectives.

該公司今天宣布了另一組積極的 3 期結果，其中 ARCT-2303（KOSTAIVE 的[單價 XBB] 變體衍生物）滿足了所有四個主要研究目標和關鍵的次要目標。

The study supports co administration of KOSTAIVE with licensed influenza vaccines. ARCT-2303 demonstrated superior immune response versus ARCT-154 as measured by neutralizing antibodies against Omicron XBB.1.5.6 in terms of geometric mean tighter or GMT ratio and a zero-conversion rate or SCR difference. Co administration of ARCT-2303 and cell based quadrivalent influenza vaccine showed non inferior immune response versus standalone QIV administration. Co administration of ARCT-2303 and QIV also showed non-inferior immune response versus standalone ARCT-2303 administration.

該研究支持 KOSTAIVE 與許可的流感疫苗合併給藥。透過針對 Omicron XBB.1.5.6 的中和抗體測量，ARCT-2303 在幾何平均數或 GMT 比率以及零轉換率或 SCR 差異方面表現出優於 ARCT-154 的免疫反應。ARCT-2303 和以細胞為基礎的四價流感疫苗的聯合施用顯示出與單獨施用 QIV 相比不差的免疫反應。ARCT-2303 和 QIV 合併給藥也顯示出與單獨 ARCT-2303 給藥相比不較差的免疫反應。

And lastly, co administration of ARCT-2303 and adjuvanted QIV in older adults showed similar responses versus standalone administration of ARCT-2303 and adjuvanted QIV. In September, the company along with our partners, CSL, Seqirus and Meiji announced new 12-month post vaccination data for KOSTAIVE at options 12 for the control of influenza conference.

最後，與單獨給予 ARCT-2303 和佐劑 QIV 相比，在老年人中聯合給予 ARCT-2303 和佐劑 QIV 表現出相似的反應。9 月，該公司與我們的合作夥伴 CSL、Seqirus 和 Meiji 在流感控制會議選項 12 上宣布了 KOSTAIVE 疫苗接種後 12 個月的新數據。

The results of a head-to-head Phase 3 study demonstrated that KOSTAIVE maintained superior immunogenicity compared to the conventional mRNA vaccine COMIRNATY for up to one year against Wuhan-Hu-1 and Omicron BA.4/5 and certain other variants handed one sixth the dose of the comparator. These results were published in the lancet infectious disease.

頭對頭3 期研究結果表明，與傳統mRNA 疫苗COMIRNATY 相比，KOSTAIVE 在長達一年的時間內針對Wuu-Hu-1 和Omicron BA.4/5 以及某些其他變種保持了優異的免疫原性，達到了六分之一比較器的劑量。這些結果發表在《刺胳針傳染病》雜誌。

Additional Phase 3 data presented at the options conference showed that bivalent KOSTAIVE also known as ARCT-2301 induced superior immunogenicity over conventional bivalent mRNA vaccine COMIRNATY that persisted against key variants up to six months post vaccination.

在選擇會議上提交的其他3 期數據顯示，二價KOSTAIVE（也稱為ARCT-2301）比傳統的二價mRNA 疫苗COMIRNATY 誘導出更好的免疫原性，後者在疫苗接種後長達六個月內能持續抵抗關鍵變異。

Now, shifting our attention to our mRNA Therapeutics franchise. Let's begin with an update on ARCT-032 ARCT-032 is an inhaled messenger RNA therapeutic for cystic fibrosis. And it's formulated with Arcturus's lunar delivery technology that differentiates us from our competitors. In September, we received clearance of an investigational new drug application to the US Food and drug administration. The FDA clearance of the IND application enables Arcturus to initiate a Phase 2 multiple ascending dose study to evaluate the safety tolerability and efficacy of ARCT-032 in people with cystic fibrosis.

現在，將我們的注意力轉移到我們的 mRNA 治療專營權上。讓我們先了解 ARCT-032 的最新情況 ARCT-032 是一種用於治療囊性纖維化的吸入式信使 RNA 療法。它採用 Arcturus 的月球交付技術配製而成，這使我們有別於競爭對手。九月，我們收到了向美國食品藥物管理局提交的新藥研究申請的批准。FDA 對 IND 申請的批准使 Arcturus 能夠啟動一項 2 期多次遞增劑量研究，以評估 ARCT-032 在囊性纖維化患者中的安全耐受性和有效性。

Our team is actively engaged in onboarding a substantial number of clinical sites to help us in this effort. We are fortunate to be able to be working closely with the CF Foundation in this process. The Phase 2 study is presently screening individuals with CF who do not qualify for or benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and or drug intolerance.

我們的團隊積極參與大量臨床站點的建設，以幫助我們實現這一目標。我們很幸運能夠在過程中與 CF 基金會密切合作。2 期研究目前正在篩選因 CFTR 蛋白功能失調或缺失和/或藥物不耐受而不符合 CFTR 調節劑藥物資格或無法從 CFTR 調節劑藥物中獲益的 CF 患者。

This study will allow us to evaluate FEB lung function improvement in individuals with CF. And I'm very pleased to report that the company is on track to share interim Phase 2 proof of concept data for our CF program. In the first half of 2025.

這項研究將使我們能夠評估 CF 患者 FEB 肺功能的改善。我很高興地向大家報告，該公司正在按計劃分享我們 CF 專案的臨時第二階段概念驗證數據。2025年上半年。

I'll now move on to our ARCT-810 program. This is our Messenger RNA therapeutic candidate for ornithine transcarbamylase or OTC deficiency. Earlier this year, Arcturus announced the expansion of the Phase 2 clinical program of ARCT-810 into the United States. This open label multiple dose study evaluating pharmacodynamics and safety is currently enrolling adults and adolescents requiring clinical management for OTC deficiency.

我現在將繼續我們的 ARCT-810 計劃。這是我們針對鳥氨酸轉氨甲酰酶或 OTC 缺乏症的 Messenger RNA 治療候選藥物。今年早些時候，Arcturus 宣布將 ARCT-810 的 2 期臨床計畫擴展到美國。這項評估藥效學和安全性的開放標籤多劑量研究目前正在招募需要針對 OTC 缺乏症進行臨床管理的成人和青少年。

Our placebo-controlled Phase 2 European study has completed the dosing phase. So these concurrent Phase 2 studies in Europe and the US will allow us to evaluate meaningful biomarker changes in individuals with OTC deficiency. And I'm happy to report that the company is on track to share interim Phase 2 proof of concept data in the first half of 2025.

我們的安慰劑對照第 2 期歐洲研究已完成給藥階段。因此，歐洲和美國同時進行的這些第二階段研究將使我們能夠評估 OTC 缺乏症個體的有意義的生物標記變化。我很高興地報告，該公司預計在 2025 年上半年分享臨時第二階段概念驗證數據。

With that, I'll now pass the call to Andy.

這樣，我現在會把電話轉給安迪。

Thank you Joe. And good afternoon, everyone. The press release issued earlier today includes financial statements for the third-quarter of 2024 and provides a summary and analysis of year over year and sequential financial performance. Please also reference our most recent form 10-Q for more details on the financial performance.

謝謝喬。大家下午好。今天稍早發布的新聞稿包括 2024 年第三季的財務報表，並對同比和連續財務業績進行了總結和分析。另請參閱我們最新的 10-Q 表格，以了解有關財務業績的更多詳細資訊。

We are very pleased with the launch of KOSTAIVE, our COVID-19 vaccine candidate in Japan. This represents an important milestone for our tourists as it is the first commercial product in the company's history. We believe that this product highlights the differentiating aspect of SA mRNA technology and how it can potentially represent an improved vaccine option for patients.

我們對我們的 COVID-19 候選疫苗 KOSTAIVE 在日本上市感到非常高興。這對我們的遊客來說是一個重要的里程碑，因為它是該公司歷史上的第一個商業產品。我們相信，該產品凸顯了 SA mRNA 技術的差異化方面，以及它如何可能代表患者改進的疫苗選擇。

I am also happy to announce that we have received a $25 million commercial milestone with the first KOSTAIVE sale in Japan. I also went to Tokyo last month to get the KOSTAIVE vaccine with 32 executives from our Arcturus, ARCALIS, CSL and Meiji.

我還很高興地宣布，隨著 KOSTAIVE 在日本的首次銷售，我們已經獲得了 2500 萬美元的商業里程碑。上個月我還和我們Arcturus、ARCALIS、CSL和Meiji的32位高階主管一起去了東京接種了KOSTAIVE疫苗。

Due to the early clinical success of our cystic fibrosis program, ARCALIS has become a strategic manufacturing asset for our tourists and therefore we have decided not to sell our stake in ARCALIS at this point in time. The strategic review process conducted by JP Morgan generated interest from financial and strategic participants which will benefit our tourists and ARCALIS in the future.

由於我們囊性纖維化計畫的早期臨床成功，ARCALIS 已成為我們遊客的戰略製造資產，因此我們決定目前不出售 ARCALIS 股份。摩根大通進行的策略審查流程引起了金融和策略參與者的興趣，這將使我們的遊客和 ARCALIS 未來受益。

We decided to expand our manufacturing product line with ARCALIS to include respiratory mRNA therapeutics and therefore, we are planning to transfer our cystic fibrosis manufacturing process technology to ARCALIS.

我們決定利用 ARCALIS 擴大我們的製造產品線，以包括呼吸 mRNA 療法，因此，我們計劃將我們的囊性纖維化製造製程技術轉移到 ARCALIS。

I will now provide a summary of our financial results for the third quarter of 2024. For the three months ended September 30th 2024, we reported revenues of $41.7 million. A slight decrease from the $45.1 million reported in the same period in 2023. This small decrease is attributable to a decrease in CSL revenue as we achieved a milestone of $35 million during Q3 of 2023 compared to a milestone of $25 million during Q3 of 2024. This was offset by an increased revenue from the BARDA agreement.

我現在將總結 2024 年第三季的財務表現。截至 2024 年 9 月 30 日的三個月，我們的收入為 4,170 萬美元。較 2023 年同期報告的 4,510 萬美元略有下降。這一小幅下降歸因於 CSL 收入的減少，因為我們在 2023 年第三季實現了 3,500 萬美元的里程碑，而 2024 年第三季則實現了 2,500 萬美元的里程碑。這被 BARDA 協議帶來的收入增加所抵消。

Total operating expenses for Q3 2024 were $52.4 million compared with $64.5 million for Q3 2023 total operating expenses for the nine months ended September 30, 2024, were $191.8 million compared with $195.9 million for the nine months ended September 30, 2023.

2024 年第三季的總營運費用為5,240 萬美元，而2023 年第三季的總營運費用為6,450 萬美元。截至2023 年9 月30 日止九個月的總營運費用為1.959 億美元。

Research and Development expenses were $39.1 million for Q3 2024, compared with $51.1 million for Q3 2023. The decrease was primarily due to $15.9 million in manufacturing expenses incurred in Q3 2023 related to the Meiji Supply Agreement and other clinical trial manufacturing batches as well as decreased facilities and equipment extension.

2024 年第三季的研發費用為 3,910 萬美元，而 2023 年第三季的研發費用為 5,110 萬美元。減少的主要原因是 2023 年第三季與明治供應協議和其他臨床試驗生產批次相關的生產費用為 1,590 萬美元，以及設施和設備擴建減少。

The decreases were primarily offset by a $3.6 million increase in clinical trial related expenses for the COVID and flu program. For Q3 2024, our tourists reported a net loss of approximately $6.9 million or $0.26 per diluted share compared with a net loss of $16.2 million or $0.61 per diluted share for Q3 2023.

這項減少主要被新冠肺炎和流感計畫臨床試驗相關費用增加 360 萬美元所抵銷。2024 年第三季度，我們的遊客報告淨虧損約為 690 萬美元或稀釋每股 0.26 美元，而 2023 年第三季的淨虧損為 1,620 萬美元或稀釋每股 0.61 美元。

Cash, cash equivalents and restricted cash were $294.1 million as of September 30 2024 and $348.9 million as of December 31 2023. Arcturus achieved a total of approximately $462.1 million in upfront payments and milestones from CSL as of September 30 2024. And expects to continue to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu program and three additional vaccine programs by CSL.

截至2024年9月30日，現金、現金等價物及限制性現金為2.941億美元，截至2023年12月31日為3.489億美元。截至 2024 年 9 月 30 日，Arcturus 從 CSL 獲得了總計約 4.621 億美元的預付款和里程碑。並預計將繼續收到 CSL 未來的里程碑付款，以支持 CSL 持續開發的新冠病毒和流感計畫以及另外三個疫苗計畫。

Based on the current pipeline and programs, the cash runway is expected to extend into the first quarter of fiscal year 2027 and does not include any contributions from the sale of KOSTAIVE vaccines in Japan.

根據目前的管道和計劃，現金跑道預計將延長至 2027 財年第一季度，並且不包括在日本銷售 KOSTAIVE 疫苗的任何貢獻。

In summary, the company remains in a strong financial position and has the cash runway needed to achieve multiple near-term value creating milestones for the vaccine and therapeutic programs. Furthermore, with the recent launch of KOSTAIVE in Japan, we look forward to reporting potential commercial revenues in 2025.

總而言之，該公司仍然保持強勁的財務狀況，並擁有實現疫苗和治療計劃的多個近期價值創造里程碑所需的現金跑道。此外，隨著 KOSTAIVE 最近在日本推出，我們期待報告 2025 年的潛在商業收入。

I will now pass the call back to Joe.

我現在將把電話轉回給喬。

Thanks Andy. We've continued to make exceptional progress on our mRNA vaccines and therapeutics pipeline. We are particularly excited about the launch of KOSTAIVE the first commercial product in the company's history. And we're also pleased that both of our flagship mRNA Therapeutic programs, ARCT-032 and ARCT-810 are on track for interim Phase 2 POC clinical data in the first half of 2025.

謝謝安迪。我們的 mRNA 疫苗和治療產品線繼續取得非凡進展。我們對 KOSTAIVE 的推出感到特別興奮，這是該公司歷史上第一個商業產品。我們也很高興我們的兩個旗艦 mRNA 治療計畫 ARCT-032 和 ARCT-810 都有望在 2025 年上半年獲得中期 2 期 POC 臨床數據。

I will now turn the call to the operator for Q&A.

我現在將電話轉給接線員進行問答。

(Operator Instructions)

（操作員說明）

Lili Nsongo, Leerink Partners.

莉莉‧恩松戈 (Lili Nsongo)，Leerink 合夥人。

Hi, good afternoon. And thank you for taking the question, I guess two questions from my side. So first question regarding the commercial launch of KOSTAIVE in Japan, any chance you could give us maybe a little more granularity. So you had mentioned that 4 million doses have been delivered to Japan through partner Meiji, that they are also upping production. I was wondering if you could give maybe a little more color on the launch trajectory in Japan and expectations for the full -- for the winter season going into 2025.

嗨，下午好。感謝您提出問題，我想我這邊有兩個問題。關於 KOSTAIVE 在日本商業發布的第一個問題，您是否有機會為我們提供更多的細節。所以你提到，400萬劑疫苗已經透過合作夥伴明治運送到日本，他們也正在增加產量。我想知道您是否可以對日本的發布軌跡以及對 2025 年冬季的整體期望提供更多資訊。

Secondly, so for the OTC deficiency study. So the European study has completed for a while now and so the American -- the US study is ongoing. Would you mind giving maybe a little more color on the number of patients and type of data we should expect in the upcoming readout in the first half of 2025.

其次，對於OTC缺陷研究也是如此。歐洲的研究已經完成了一段時間，美國的研究正在進行中。您介意在 2025 年上半年即將發布的數據中對患者數量和數據類型進行更多說明嗎？

Hey, thanks Lili for the question, Andy with respect to the additional nuance on the commercialization process in Japan. Do you want to handle that question?

嘿，謝謝莉莉提出的問題，安迪關於日本商業化進程的額外細微差別。你想回答這個問題嗎？

Sure, thanks Lili. We're pretty excited about working with Meiji in Japan because as you know, they're the number one flu vaccine company. And so they're in a very strong position to be able to launch the product very effectively. And if you may have paid attention to a recent press release, they've actually articulated that they were planning to sell roughly 4.5 million vaccines during the season with the guidance.

當然，謝謝莉莉。我們對與日本明治公司合作感到非常興奮，因為如您所知，他們是排名第一的流感疫苗公司。因此，他們處於非常有利的地位，能夠非常有效地推出產品。如果您可能有關注最近的新聞稿，他們實際上已經明確表示，他們計劃在該季度銷售約 450 萬劑疫苗。

And of course, you know, we only shipped 4 million and of course, the remaining vaccines must have come from the opportunity to produce them in ARCALIS in Japan. So we're all awaiting the announcement of that approval by the [PMDA] shortly which should enable Meiji to have a full launch by probably December or so with a vaccine that's actually made in Japan. So pretty exciting, I think for not only Meiji and CSL but the Japanese people overall.

當然，你知道，我們只發貨了 400 萬支，當然，剩下的疫苗肯定來自日本 ARCALIS 生產的機會。因此，我們都在等待 [PMDA] 很快宣布批准，這將使明治能夠在 12 月左右全面推出實際上在日本製造的疫苗。非常令人興奮，我認為不僅對明治和中超，而且對整個日本人民來說。

So we're not really privy to give specific guidelines other than what they've been able to articulate publicly. But I would closely pay attention to any communications coming from Meiji and CSL regarding the launch and progress of the vaccine sales in Japan.

因此，除了他們能夠公開闡明的內容之外，我們並不太願意提供具體的指導方針。但我會密切關註明治和 CSL 有關疫苗在日本銷售的啟動和進展的任何資訊。

And pertaining to the OTC question, Lili, the US expansion is going to be similar in size relative to what we did in Europe. We are enrolling younger and more advanced disease subjects. We did see some early signals that we're encouraging in the European trial. But we're going to be combining this data in what we share in the first half of next year.

關於場外交易問題，莉莉，美國的擴張規模將與我們在歐洲的擴張規模相似。我們正在招募更年輕、更晚期的疾病受試者。我們確實看到了一些早期信號，表明我們在歐洲試驗中感到鼓舞。但我們將在明年上半年分享這些數據。

Thank you.

謝謝。

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米，派珀·桑德勒。

Hey, good afternoon team. This is Jim Juan for Yas. Thanks for taking our questions. First, to the extent that you can for the Phase 2 systic fibrosis study. Could you provide any color on the size and cohorts that you're thinking about? What doses are you planning to move forward with? And then for the second question, what is needed to demonstrate proof of concept in your view.

嘿，團隊下午好。我是亞斯的吉姆·胡安。感謝您回答我們的問題。首先，盡可能進行第 2 期系統性纖維化研究。您能否提供有關您正在考慮的規模和群組的任何顏色？您打算繼續服用什麼劑量？然後對於第二個問題，您認為需要什麼來證明概念驗證。

Pad, do you want to ask that question? The CF study?

帕德，你想問這個問題嗎？CF研究？

Yeah I mean, you know, obviously if you look at, you know, we are going to be looking at what a lot of our competitors are doing in terms of looking at the various biomarkers. And we can't disclose a lot about the actual study design and our plan is to again recruit -- we finished our Phase 2 study, we plan to start our study in the US. And we'll provide more data around our CS study later on this year. I mean, early next year.

是的，我的意思是，你知道，顯然，如果你看看，你知道，我們將看看我們的許多競爭對手在研究各種生物標誌物方面正在做什麼。我們不能透露太多有關實際研究設計的信息，我們的計劃是再次招募——我們完成了第二階段研究，我們計劃在美國開始我們的研究。今年晚些時候，我們將提供有關電腦科學研究的更多數據。我的意思是，明年初。

Yeah, multiple doses are going to be evaluated in the CF study. It's an open label study. There's no bronchoscopy included in this study.

是的，CF 研究將評估多劑量。這是一項開放標籤研究。這項研究不包括支氣管鏡檢查。

And FEV is going to be measured throughout the study. But with respect to specific time points and additional details, there'll be an appropriate time for us to share that. And that'll be at a later time.

FEV 將在整個研究過程中進行測量。但具體時間點和其他細節，我們會在適當的時間來分享。那是稍後的事了。

Got it. Thank you.

知道了。謝謝。

Whitney Ijem, Canaccord Genuity.

惠特尼·艾傑姆，Canaccord Genuity。

Hey, guys, thanks for taking the question. First, I just wanted to follow up on the commentary around vaccines in Japan and the switch to ARCALIS once it's approved, it is the idea that when ARCALIS is approved and it's manufactured domestically in Japan, that there will be kind of a step up or an acceleration. Just as we think about modeling quarter over quarter next year.

嘿，夥計們，謝謝你提出問題。首先，我只是想跟進日本有關疫苗的評論以及 ARCALIS 獲得批准後轉向 ARCALIS，我的想法是，當 ARCALIS 獲得批准並在日本國內生產時，將會有某種進步或加速度。正如我們考慮明年逐季度建模。

And then the second question to follow up on OTC, I think looking back the date interim phase two data had originally been expected in the fourth quarter. So maybe I missed it. But what drove the shift to the first half of next year? Thanks.

然後是 OTC 跟進的第二個問題，我認為回顧中期第二階段數據的日期最初預計是在第四季度。所以也許我錯過了。但是是什麼推動了這項轉變到明年上半年呢？謝謝。

Andy. Do you want to address the first question?

安迪.您想解決第一個問題嗎？

Sure, Whitney. No, I think you were spot on there with that assessment and as you can tell Meiji and ARCALIS are very proud to obviously be able to manufacture the first SA mRNA vaccine in Japan. And it was pretty evident by the response in the press that we're all, you know, in attendance, they had over 30 press officials there. So a pretty well attended press conference.

當然，惠特尼。不，我認為您的評估是正確的，您可以看出，明治和 ARCALIS 非常自豪能夠在日本生產第一個 SA mRNA 疫苗。從媒體的反應中可以明顯看出，我們都出席了，他們有 30 多名新聞官員在場。所以這是一場出席人數相當多的記者會。

And certainly, I think they would probably prefer to launch and articulate that this vaccine is made in Japan and certainly having shipments from ARCALIS in December will enable them to articulate that more clearly. So, with respect to probably a more aggressive commercial launch, you could probably anticipate, it would happen in December, January time frame, in my opinion. So, if you're looking at the timing of the revenues, probably would happen in the, you know, probably the first two quarters of next year.

當然，我認為他們可能更願意推出並明確表示這種疫苗是在日本製造的，當然，12 月從 ARCALIS 發貨將使他們能夠更清楚地闡明這一點。因此，對於可能更積極的商業發布，您可能會預期，在我看來，它將在 12 月、1 月的時間範圍內發生。因此，如果你考慮收入的時間，可能會發生在明年的前兩個季度。

And with respect to the OTC data, we did complete dosing in Europe and there was some early evaluation of some of that data. The data is not locked and we initiated the enrolling process in the US prior to that process. So we thought it was wise to just couple these together and provide the interim data update in the first half of next year.

關於 OTC 數據，我們在歐洲完成了劑量給藥，並對其中一些數據進行了一些早期評估。數據未鎖定，我們在此流程之前在美國啟動了註冊流程。因此，我們認為將這些結合起來並在明年上半年提供臨時數據更新是明智的。

Understood. Thanks.

明白了。謝謝。

Evan Wang, Guggenheim Securities.

艾文王，古根漢證券。

Hi guys. Thanks for the question. Just a few from me. Firstly, on KOSTAIVE, anything you can share on broader vaccination trends in Japan. So not just (inaudible) specific, I know the Japanese season starts later, but has it been in line with major estimates to support the dose totals for the season.

嗨，大家好。謝謝你的提問。只是我的一些。首先，在 KOSTAIVE 上，您可以分享有關日本更廣泛的疫苗接種趨勢的任何資訊。因此，不僅僅是（聽不清楚）具體，我知道日本季節開始較晚，但它是否符合支持該季節劑量總量的主要估計。

And also KOSTAIVE, you highlighted kind of recognizing revenue in 2025. Can you remind us some of the reporting here and how our Arcturus recognizes some of this revenue?

還有 KOSTAIVE，您強調了 2025 年確認收入的情況。您能否提醒我們這裡的一些報告以及我們的 Arcturus 如何確認其中部分收入？

And then third on OTC and cystic fibrosis, you know, I was just wondering -- it's great to see the timeline for proof concept in the first half '25. Just wondering what gives confidence in some of these timelines. Is dosing in recruitment thus far better than expected, any additional color? That would be helpful. Thanks.

然後是關於非處方藥和囊性纖維化的第三個，你知道，我只是想知道 - 很高興在 25 年上半年看到證明概念的時間表。只是想知道是什麼讓人們對其中一些時間表充滿信心。到目前為止，招募的劑量是否比預期的好，還有其他顏色嗎？那會有幫助的。謝謝。

Sure. Let's see -- you had a question about revenues. Do you want to address that first, Andy?

當然。讓我們看看—您有一個關於收入的問題。安迪，你想先解決這個問題嗎？

Sure. As you can see, when Meiji will sell the vaccines in Japan, they will be reporting those sales to CSL on a quarterly basis. CSL then will in turn determine the allocation of the profit share between CSL Meiji and Arcturus. At that point in time, you know, we'll be able to recognize those revenues once that allocation is, contributed to our Arcturus.

當然。正如您所看到的，當明治將在日本銷售疫苗時，他們將按季​​度向 CSL 報告這些銷售情況。隨後，CSL 將決定 CSL Meiji 和 Arcturus 之間的利潤分配。到那時，您知道，一旦分配給我們的 Arcturus，我們就能夠確認這些收入。

And keep in mind that we do have to offset the initial revenue by the 40% of the production costs that we are responsible for in the development of the program. And so that amount has not been communicated officially, but you can assume that that would probably incur at least, you know, a few million doses before you're able to offset those initial 40% of the development and production cost for the KOSTAIVE vaccine. I hope that was helpful.

請記住，我們確實必須用我們在程式開發中負責的 40% 的製作成本來抵消初始收入。因此，這個金額尚未正式公佈，但你可以假設，在你能夠抵消 KOSTAIVE 疫苗最初 40% 的開發和生產成本之前，這可能至少需要數百萬劑。我希望這有幫助。

And addressing your second, or questions about the KOSTAIVE trend and the CF timeline. I can comment that the team was in Japan and we got a really good feel for Meiji's presence in Japan in the vaccine industry. They have a large sales force. They have approximately 40% of the flu shot business in Japan. So it was really good to see what kind of materials they're providing to just a large number of physicians in Japan, as you can imagine.

並解決您的第二個問題，即有關 KOSTAIVE 趨勢和 CF 時間表的問題。我可以評論說，該團隊在日本，我們對明治在日本疫苗行業的存在有非常好的感覺。他們擁有龐大的銷售團隊。他們擁有日本約 40% 的流感疫苗業務。所以很高興看到他們為日本的大量醫生提供了什麼樣的材料，正如你可以想像的那樣。

So, clearly there's a educational phase of the launch teaching people about this next generation technology, but any additional details than that, it would be more appropriate to just for them to provide with their regular updates with respect to commercial guidance. But all I can say is that I was very impressed with the management team and the commercial staff there that they really knew what they were doing.

因此，顯然，發布有一個教育階段，向人們傳授下一代技術，但除此之外的任何其他細節，讓他們提供有關商業指導的定期更新會更合適。但我只能說，那裡的管理團隊和商務人員給我留下了深刻的印象，他們真的知道自己在做什麼。

With respect to the CF timeline, the reason we're very comfortable on this is, first of all, if you notice the design of our trial is, I would say, open label. It's not placebo controlled. There's no bronchoscopy involved or lung brushing, which can deter participants from participating.

關於 CF 時間表，我們對此感到非常滿意的原因是，首先，如果您注意到我們試驗的設計，我會說，開放標籤。它不是安慰劑控制的。不涉及支氣管鏡檢查或肺刷檢，這可能會阻止參與者參與。

And we also have some early data that we've already shared in Phase 1B, including a Class 1 subject that had some early and promising data. So I think that data collection is helping us. We're also working with the CF Foundation. And as we're onboarding a substantial number of sites, I think it's given us encouragement with these preliminary conversations that we should be well on track to deliver some data in the first half of next year.

我們也擁有一些已經在 1B 階段共享的早期數據，其中包括一個擁有一些早期且有希望的數據的 1 級主題。所以我認為數據收集對我們有幫助。我們也與 CF 基金會合作。隨著我們加入大量網站，我認為這些初步對話給了我們鼓勵，我們應該能夠在明年上半年提供一些數據。

Myles Minter, William Blair.

邁爾斯·明特，威廉·布萊爾。

Hey, thanks for taking the questions. Three quick ones if I may. The first one is just on the guidance that you'd get the EMA approval milestone from CSL for potential approval of KOSTAIVE in the first quarter of '25. Does that imply that you'd expect to see a chimp opinion issued at either the November or December meeting by the end of this quarter? First one.

嘿，感謝您提出問題。如果可以的話，三個快點。第一個只是指導您將獲得 CSL 的 EMA 批准里程碑，以便 KOSTAIVE 可能在 25 年第一季獲得批准。這是否意味著您希望在本季末之前的 11 月或 12 月會議上看到黑猩猩意見？第一個。

The second one is on the decision to keep the ARCALIS equity stake. Does that mean if Meiji does give additional manufacturing orders of cost save to ARCALIS, that's something you could actually report on rather than just pushing back to Meiji for commercial guidance?

第二個問題是關於保留 ARCALIS 股權的決定。這是否意味著，如果明治確實向 ARCALIS 提供了額外的成本節約製造訂單，那麼您實際上可以報告此事，而不僅僅是向明治尋求商業指導？

And the third question is moving the CF program manufacturing to ARCALIS and having a U.S. focus Phase 2 clinical trial, does that mean you have to get FDA inspection of that facility? Thanks very much.

第三個問題是將 CF 計畫的製造轉移到 ARCALIS 並進行美國重點 2 期臨床試驗，這是否意味著您必須接受 FDA 對該設施的檢查？非常感謝。

Andy. Do you want to provide the first half?

安迪.您想提供前半部嗎？

Sure. No, it's -- we were obviously very encouraged by the opportunity with the early progress we've had in cystic fibrosis. So obviously manufacturing and trying to plan strategically a global production base is quite daunting, because just to address, just to give you an idea, just to address the Class 1 population, you're looking at probably 17, roughly, kilograms per year. And so you need to put together a very well orchestrated manufacturing base to be able to address all that. And of course, ARCALIS has now become very strategic because of that opportunity.

當然。不，是的——我們顯然對囊性纖維化方面取得的早期進展的機會感到非常鼓舞。顯然，製造和試圖策略性地規劃全球生產基地是相當令人畏懼的，因為只是為了解決這個問題，只是為了給你一個想法，只是為了解決1 類人口的問題，你每年可能會看到大約17公斤。因此，您需要建立一個精心策劃的製造基地才能解決所有這些問題。當然，由於這個機會，ARCALIS 現在已經變得非常具有戰略意義。

And consequently, they are a very low cost and very efficient operation, because as you know, the drug substance, drug product and DNA is all made there. And so it's by authorization and the sale finish. So having all that in one location reduces a substantial amount of transportation logistical risk, especially with transferring drug substance to Europe for the drug product completion stage. And so, there are many implications and opportunities. And obviously, as you have just heard, the amount of mRNA we're going to need to make for the CF program is quite substantial.

因此，它們的成本非常低且非常高效，因為如您所知，原料藥、藥品和 DNA 都是在那裡生產的。就這樣透過授權和銷售完成。因此，將所有這些都集中在一個地點可以大大降低運輸物流風險，特別是在將原料藥轉移到歐洲進行藥品完成階段時。因此，有很多影響和機會。顯然，正如您剛剛聽到的，我們需要為 CF 專案製造的 mRNA 量相當大。

And based on just the capacity ARCALIS has now, that's about [100 million] a year just for ARCALIS and sales. And that's only considering two kilograms out of the 17. So just to give you the significant impact of this opportunity is pretty substantial. So we've had to reevaluate our global supply base and working very closely with Aldevron and Danaher, of course, and Catalent and Recipharm and Polymun.

僅根據 ARCALIS 目前的產能，每年僅 ARCALIS 和銷售額就約為 [1 億]。這還只是 17 公斤中的兩公斤。因此，僅僅為您帶來這個機會的重大影響就相當巨大了。因此，我們必須重新評估我們的全球供應基地，並與 Aldevron 和 Danaher（當然，還有 Catalent、Recipharm 和 Polymun）密切合作。

And so this has taken on a very global concerted effort. It's exciting, but it's going to take a little bit of work. And certainly it makes ARCALIS a much more valuable partner right now, and we need them. And we're kind of excited about working more closely with them on the CF program.

因此，這是全球共同努力的成果。這很令人興奮，但需要做一些工作。當然，這使得 ARCALIS 現在成為更有價值的合作夥伴，我們需要他們。我們很高興能夠在 CF 專案上與他們進行更密切的合作。

And pertaining to EMA approval, we've clearly guided today that we're anticipating a CHMP decision in December. And that obviously precedes a formal approval process shortly thereafter that takes us into Q1. So I think your assumption is fair.

關於 EMA 批准，我們今天明確表示，我們預計 CHMP 將於 12 月做出決定。這顯然是在不久之後的正式批准流程之前進行的，這將我們帶入第一季。所以我認為你的假設是公平的。

Did we address all your questions, Myles?

我們解決了你所有的問題嗎，邁爾斯？

Just a quick one on the second one. Just with the manufacturing orders that could come to Meiji when the PMDA issues approval in December, if they do that, is that something you, as Arcturus, would be able to report on if they do indeed receive a bulk manufacturing order for KOSTAIVE? Thanks.

只是快速介紹第二個。當 PMDA 在 12 月批准時，明治可能會收到製造訂單，如果他們這樣做，作為 Arcturus，如果他們確實收到了 KOSTAIVE 的批量製造訂單，您是否能夠報告這一點？謝謝。

Yeah, the short. No, but Andy yeah, go ahead.

是的，短的。不，但是安迪，是的，繼續吧。

We really can't comment on those, because that'll be up to Meiji and CSL to articulate that. Of course, we'll give you as much color as we can post quarter, and hopefully that'll enable you to have a better insight as to the ramp-up and the success of the ARCALIS production on a quarterly basis.

我們確實無法對此發表評論，因為這將由明治和中超聯賽來闡明。當然，我們會在季度後為您提供盡可能多的信息，希望這能讓您更了解每季 ARCALIS 生產的進展和成功情況。

Awesome, appreciate you taking all the questions. Thanks.

太棒了，感謝您回答所有問題。謝謝。

Yanan Zhu, Wells Fargo.

朱亞楠，富國銀行。

Hi, thanks for taking our question. This is [Quan Nguyen] for Yanan. So I have a question on your CF program. Can you share with us your barcode for success on FEV1? And also, Vertex Moderna will report their VX-522 phase 1 with data also in first half '25. So can you remind us the differentiation of 032 versus VX-522? Thank you.

您好，感謝您提出我們的問題。這是延安的[Quan Nguyen]。我對你們的 CF 計畫有一個疑問。您能與我們分享您在 FEV1 上取得成功的條碼嗎？此外，Vertex Moderna 也將在 25 年上半年報告其 VX-522 第一階段的數據。那您能提醒我們032與VX-522的差別嗎？謝謝。

Yes, it's definitely a wonderfully competitive area. And I think this is great for patients in general in the CF community. But we do have key differentiation elements to our program and our technology compared to our competitive peers. So thank you for the question. The first and foremost, we have a different delivery technology that we call Lunar. But this not only has a different registered trademark, but it's a chemically different lipid nanoparticle that is biodegradable, non-accumulating. And we believe these chemical differences have proven out to provide differentiated data pre-clinically.

是的，這絕對是一個競爭非常激烈的領域。我認為這對於 CF 社群的廣大患者來說非常有用。但與競爭對手相比，我們的計畫和技術確實有關鍵的差異化要素。謝謝你的提問。首先也是最重要的，我們有一種不同的交付技術，我們稱之為 Lunar。但這不僅有不同的註冊商標，而且它是一種化學成分不同的脂質奈米顆粒，可生物降解、非累積。我們相信這些化學差異已被證明可以在臨床前提供差異化數據。

So we have pre-clinical data in the ferret model that has shown that we have a very significant response that supersedes positive control after a single administration. I think that would be representative of the differentiation I'm speaking to. We're also sharing data more visibly. We've already provided some phase 1B data and a class 1 subject that has provided some promising early response after just two administrations. And then finally, a purification IP, I think, is a differentiator. And this is a big deal in the therapeutic space.

因此，我們在雪貂模型中的臨床前數據表明，我們在單次給藥後產生了非常顯著的反應，取代了陽性對照。我認為這代表了我所說的差異化。我們也更加明顯地共享數據。我們已經提供了一些 1B 期數據和 1 類受試者，該受試者在僅僅兩次給藥後就提供了一些有希望的早期反應。最後，我認為淨化 IP 是一個差異化因素。這在治療領域是一件大事。

When you're dosing chronically and larger amounts of mRNA, it's very important, especially in compromised lungs, like the CF patient population, that these mRNA molecules are substantially pure. And we have a potentially leadership position in this space. And with intellectual property behind it, it's different. How we purify our mRNAs is likely different than our competitors. But I'll stop there. I could talk for a while. But I think those are the key differentiators.

當您長期服用大量 mRNA 時，這些 mRNA 分子基本上是純淨的，這一點非常重要，尤其是在肺部受損的情況下，例如 CF 患者群體。我們在這個領域擁有潛在的領導地位。有了智慧財產權的支持，情況就不同了。我們純化 mRNA 的方式可能與我們的競爭對手不同。但我就到此為止。我可以聊一會兒。但我認為這些都是關鍵的差異化因素。

I got it. Thanks for all the colors. And would you mind sharing your barcode success on FEV1?

我得到了它。感謝所有的顏色。您介意分享您在 FEV1 上條碼的成功嗎？

Did you say our expectations around FEV1? What was your question?

您是否說過我們對 FEV1 的期望？你的問題是什麼？

Yeah.

是的。

Because we're addressing the patient population where there's substantial unmet medical need. Again, these are the non-modulator responders. That's about 15% to 18% of the CF population. So we're going after these folks that do not really have an excellent treatment option. So the barrier for entry, the bar that we need to establish for lung function improvement, I believe, is very small.

因為我們正在解決大量未滿足醫療需求的患者群體。同樣，這些是非調製器響應者。這大約佔 CF 族群的 15% 到 18%。因此，我們正在尋找那些實際上沒有很好的治療選擇的人。因此，我認為，我們為改善肺功能而需要建立的進入門檻非常小。

We haven't provided any details on that. And with respect to our conversations with regulatory agencies, for example, we hold those cards close to our chest. But the short answer is anything measurable, I believe, would be very significant for this patient population. A small percentage improvement would be very meaningful, in our view. But we haven't given that specific number yet. There will be an appropriate time later down the road.

我們尚未提供任何相關細節。例如，對於我們與監管機構的對話，我們將這些牌放在心上。但簡單的回答是，我相信任何可測量的東西對於這個患者群體來說都是非常重要的。我們認為，一小部分的改進將非常有意義。但我們還沒有給出具體數字。稍後會有適當的時間。

Yes, thank you for that. And one quick question on 2303. Congrats on the data. Can you share with us what's the next step for the program? Are you ready to file, or what's your strategy? Thank you.

是的，謝謝你。還有一個關於 2303 的快速問題。恭喜數據。您能與我們分享一下該計劃的下一步嗎？您準備好提交文件了嗎？謝謝。

2303. The strategic purpose for these other Phase III trials was just to showcase the breadth of the platform, that the technology can be multi-antigenic, for example, in the bivalent trials we're doing, and also in where we're conducting these trials, is meaningful because we're collecting an expanded safety database in multiple ethnicities around the world with these additional Phase III trials. Taking that all together, it helps beef up and support a really strong BLA application in the first half of next year. So they're strategically important to support the BLA application in the US I don't foresee us marketing these products. The data is used to support the platform of KOSTAIVE in the United States.

2303.這些其他 III 期試驗的戰略目的只是展示該平台的廣度，該技術可以是多抗原的，例如，在我們正在進行的二價試驗中，以及在我們正在進行這些試驗的地方，是有意義的，因為我們正在透過這些額外的III 期試驗收集世界各地多個種族的擴展安全資料庫。綜上所述，它有助於增強並支持明年上半年真正強大的 BLA 申請。因此，它們對於支援美國的 BLA 應用具有重要的戰略意義，我預計我們不會行銷這些產品。此數據用於支援美國KOSTAIVE平台。

Got it. Thank you for all the colors.

知道了。謝謝你提供的所有顏色。

Thank you.

謝謝。

Pete Stavropoulos, Cantor Fitzgerald.

皮特·斯塔夫羅普洛斯，康托·菲茨傑拉德。

Hi, this is Samantha Schaeffer on the line for Pete. Thanks for taking our question. Can you touch on the H5N1 pandemic flu program? If you could remind us on key details for this non-CSL partner program and what to expect. Thanks.

大家好，我是薩曼莎·謝弗 (Samantha Schaeffer)，正在接聽皮特 (Pete) 的電話。感謝您提出我們的問題。能談談 H5N1 大流行性流感計畫嗎？您能否提醒我們有關此非 CSL 合作夥伴計劃的關鍵細節以及預期內容。謝謝。

Thank you. The short answer to that question is we remain on track to get into the clinic this year. So thank you for the question. H5N1 is definitely important to BARDA. We do have some BARDA references in our filing documents and our press release and probably the script as well. You can see that we're elevating our relationship with them. But that stage, that stage of getting into the clinic is coming up here shortly.

謝謝。對這個問題的簡短回答是，我們仍然有望在今年進入臨床。謝謝你的提問。H5N1 對 BARDA 來說絕對重要。我們的備案文件和新聞稿中確實有一些 BARDA 參考資料，可能還有劇本。您可以看到我們正在提升與他們的關係。但那個階段，進入診所的階段很快就會到來。

Ed Arce, HC Wainwright.

埃德·阿爾塞，HC 溫賴特。

Hi, everyone. This is Thomas Hoffmann, of course. Congratulations on your progress today. So first question, wondering what the Phase 2 data readout for (inaudible) and OTC expected in first half next year. Which efficacy measurement do you believe has the potential to support approval endpoints, or which efficacy endpoints should investors focus on?

大家好。當然，這是托馬斯·霍夫曼。恭喜你今天的進步。所以第一個問題，想知道明年上半年的第二階段資料讀出（聽不清楚）和場外交易預計是什麼。您認為哪種功效衡量標準有可能支持批准終點，或者投資者應該關注哪些功效終點？

That's actually a really good question. The data we're collecting is not only important to establish proof of concept for intravenously dosed mRNA in our platform, but a key part of the OTC strategy is to identify the appropriate biomarker if we choose to advance this into a pivotal trial or a phase three trial.

這實際上是一個非常好的問題。我們收集的數據不僅對於在我們的平台中建立靜脈注射 mRNA 的概念證明很重要，而且如果我們選擇將其推進到關鍵試驗或階段，OTC 策略的關鍵部分是確定適當的生物標記三審。

So it's not just the data that's important in this first half of 2025 but understanding which of these many biomarkers that we're collecting data on, many of them. And we believe we have a strategy that is going to be appropriate for a phase three or pivotal trial. But we won't be communicating specifically what that biomarker strategy is today. That's something that we can do concurrently with the interim data sharing in the first half of next year.

因此，2025 年上半年重要的不僅是數據，還包括了解我們正在收集的眾多生物標記物中的哪些數據。我們相信我們有一個適合第三階段或關鍵試驗的策略。但我們今天不會具體傳達生物標記策略是什麼。這可以與明年上半年的臨時資料共享同時進行。

Got it. And then for the other program, I do have this partner with CSL. Are there any updates with the Lunar flu program? I believe last we heard this Phase 1 [study]?

知道了。對於另一個項目，我確實有中超聯賽的合作夥伴。月球流感計畫有任何更新嗎？我相信我們上次聽到這個第一階段[研究]？

Yeah, good question. Our CSL collaboration in the flu is a very active one. I'll say that. Its multiple programs are involved. The funding for these programs has been increasing. We're meeting regularly in JSC meetings with CSL. But with respect to the cadence of data sharing and any sort of commercial strategy on these, we respectively agree with CSL that will allow them to provide that information.

是的，好問題。我們中超聯賽在流感方面的合作非常活躍。我會這麼說。其涉及多個程序。這些項目的資金一直在增加。我們定期與 CSL 舉行 JSC 會議。但就數據共享的節奏和任何形式的商業策略而言，我們分別同意 CSL 的觀點，這將允許他們提供這些資訊。

So all we can say with respect to the flu program is that it's very active. There's multiple programs and that funding is increasing for these programs. And it's definitely a priority for our collaboration. But again, how the data is shared and the cadence of that data and any sort of commercial strategy and what it's combined with and the bundling commercial strategies, these kind of things we can't refer to at all. But thanks for the question.

因此，關於流感計劃，我們只能說它非常活躍。有多個項目，這些項目的資金正在增加。這絕對是我們合作的首要任務。但同樣，數據如何共享、數據的節奏以及任何類型的商業策略以及它與什麼相結合以及捆綁商業策略，這些我們根本無法提及。但謝謝你的提問。

Got it. One more question from us, this one first, Andy. Just wonder, what's the entire $25 million milestone from UG? Was that entire amounts recognized in third quarter or it's going to be spread over several quarters?

知道了。我們還有一個問題，首先是這個，安迪。只是想知道，UG 的 2500 萬美元里程碑是多少？全部金額是在第三季確認還是分攤到幾季？

Yes, the 25 million when it's recognized, go ahead, Andy, yes.

是的，2500萬當它被認可時，繼續吧，安迪，是的。

Yes, thank you, Joe. Yes, the 25 million is going to be reported just like all of our other development milestones at this point in time. And the SC-606 requires that we probably amortize around 90% to 93% of the milestone in the quarter that it was earned. And then the remaining amount is amortized over a production to complete method. And so that's why you see the accruals on some of the CSL revenues that occur on a recurring basis in our quarters. So hopefully that gives you a perspective of what we've recorded here in the quarter.

是的，謝謝你，喬。是的，就像我們此時所有其他發展里程碑一樣，將報告 2500 萬個。SC-606 要求我們可能在獲得它的季度攤銷大約 90% 到 93% 的里程碑。然後剩餘金額以生產完成方法攤銷。這就是為什麼您會看到我們季度中經常性發生的一些 CSL 收入的應計收入。希望這能讓您了解我們本季記錄的情況。

Got it. Thank you for taking all the questions. Looking forward to upcoming progress with KOSTAIVE in Japan.

知道了。感謝您回答所有問題。期待與 KOSTAIVE 在日本取得的進展。

Thank you.

謝謝。

Thank you.

謝謝。

Yale Jen, Laidlaw & Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

Great, thanks for taking the question. My first question is that giving the three parties will be involved in terms of determining the allocations. So should we anticipate any potential royalty from revenue from Japan will be something of next year instead of the last quarter of this year?

太好了，感謝您提出問題。我的第一個問題是，三方都將參與確定分配。那麼，我們是否應該預期來自日本的收入的任何潛在特許權使用費將在明年而不是今年最後一個季度進行？

The timing of revenue recognition. Yeah, go ahead. Andy.

收入確認的時間。是的，繼續吧。安迪.

Yes, Yale. I think if you listen closely to what we were articulating, by the time Meiji reports the sale to CSL and then they will in turn determine the allocation, you're probably better off assuming that the sales will be recognized in the first half of next year rather than this year.

是的，耶魯。我認為，如果你仔細聽我們所說的，當明治向 CSL 報告銷售情況，然後他們將依次確定分配時，你最好假設銷售將在明年上半年得到確認年而不是今年。

So hopefully that gives you some perspective because remember we also have the 40% of the production costs that we have to absorb before we're able to recognize any revenues. So I think I would prefer to caution on the conservative side and probably anticipate the first half of next year, the better predicament of when we can see some of those revenues. Hopefully that helps you.

希望這能為您提供一些視角，因為請記住，在我們能夠確認任何收入之前，我們還必須吸收 40% 的生產成本。因此，我認為我寧願保持保守的態度，並可能預計明年上半年，屆時我們可以看到其中一些收入，情況會更好。希望這對您有幫助。

Yes, it does. And maybe just to tag on one more question, at least on the P&L side. I noticed that this quarter's R&D expenses was lower than the sort of prior two quarters. I understand you have changes from the last years, but should we anticipate this a little bit lower R&D expenses will continue or how should we think about that?

是的，確實如此。也許只是再標記一個問題，至少在損益方面。我注意到本季的研發費用低於前兩季。我知道您與過去幾年相比發生了變化，但我們是否應該預期研發費用會繼續下降，或者我們應該如何看待這一點？

That's a good question. And one of the reasons why it's so difficult to give quarterly guidance because of the functionality of when trials are completed and when inventory is shipped. So that's why I prefer to provide a runway guidance, and so if you can be reassured that we had restated that our guidance is in the first quarter of '27, so that's remained consistent now for a few quarters.

這是個好問題。由於試驗何時完成和庫存何時發貨的功能，很難提供季度指導的原因之一。這就是為什麼我更願意提供跑道指南，所以如果您可以放心，我們已經重申我們的指南是在 27 年第一季度，所以現在幾個季度都保持一致。

So you can assume that our burn is going to be somewhere around $100 million a year. And if you divide that by the cash we have, that should give you some comfort that we should be easily achieving that first quarter of '27 goal. And keep in mind that it doesn't include any revenue contributions from Japan. So hopefully we'll be able to update the market next year on that progress.

因此，您可以假設我們每年的消耗約為 1 億美元。如果你用它除以我們擁有的現金，這應該會讓你感到一些安慰，我們應該很容易實現 27 年第一季的目標。請記住，它不包括來自日本的任何收入貢獻。因此，希望明年我們能夠向市場通報這項進展的最新情況。

Great, and maybe the last question here in terms of 2303 combined with the QIV, how should we think about that going forward in terms of these combined vaccines? Would that be something that the CSL will make a decision on the specific?

太好了，也許最後一個問題是關於 2303 與 QIV 結合的問題，我們應該如何考慮這些聯合疫苗的未來發展？中超是否會就此做出具體決定？

Exactly, yes, yes. We now have the phase three data to show that non-inferiority or equivalence, right? So CSL will be determining anything to doing with commercial strategy and especially with the flu, they provide that, whether it's combos or co-promotions or bundling, anything like that, that'll all come from them.

沒錯，是的，是的。我們現在有了第三階段的數據來顯示非劣效性或等效性，對吧？因此，CSL 將決定與商業策略有關的任何事情，尤其是與流感有關的事情，他們規定，無論是組合、聯合促銷還是捆綁銷售，諸如此類的事情，都將來自他們。

Okay, great. Thanks a lot. And congrats on the progress.

好的，太好了。多謝。並祝賀取得的進展。

Yeah, thank you.

是的，謝謝。

Thank you.

謝謝。

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

Hi, guys, I hope you can hear me okay. Just first of all, could you just clarify $25 million milestone from Japan? Is that counts receivable and or is it actually your cash report at the end of the quarter? Thanks.

嗨，夥計們，我希望你們能聽到我的聲音。首先，您能澄清一下來自日本的 2500 萬美元里程碑嗎？這是應收帳款還是季末的現金報告？謝謝。

Yes, no, good question. We give CSL about 60 days to pay the bill. So, and they've been a pretty good customer. So I'm not too worried about getting that $25 million. Hopefully that alleviates your concern about them paying us.

是的，不，好問題。我們給CSL大約60天的時間來支付帳單。所以，他們是一個非常好的客戶。所以我不太擔心能否拿到那 2500 萬美元。希望這能減輕您對他們向我們付款的擔憂。

Okay. And then on the manufacturing, I'm just wondering, so you're saying that you're going to transfer the manufacturing on the CF over there. The capacity is left at our college after including CF on top of COVID. And do you have, do they have the capability there to do the fill and finish for the specialization of the CF product given that it's going to be the nebulized product? Is there anything else that they need to incorporate into the manufacturing chain to do that piece of things?

好的。然後關於製造，我只是想知道，所以你說你要把製造轉移到那裡的CF。在將 CF 包含在 COVID 之上後，我們學院還剩下容量。鑑於 CF 產品將是霧化產品，他們是否有能力對 CF 產品進行專業化的填充和加工？他們還需要將其他東西納入製造鏈才能完成這件事嗎？

No, it's a short answer, no. Go ahead.

不，這是一個簡短的回答，不。前進。

Yes, we can go ahead, let Pad answer that if he has any more color on the production.

是的，我們可以繼續，讓 Pad 回答他是否對製作有更多的意見。

Yes, again, the process for making our drug substance for both our CF product as well as our vaccine products are very similar. So that's the great beauty about messenger RNA. I think we can use the very similar process for all the APIs and all of our programs that we're currently having internally. There's obviously nuances related to a lyophilized product or a frozen drug product. And I think that there is some specific and the components, exact components that are in our CF product are different than what we're currently using for our vaccines.

是的，我們的 CF 產品和疫苗產品的原料藥製造過程非常相似。這就是信使 RNA 的偉大之處。我認為我們可以對所有 API 和我們目前內部擁有的所有程式使用非常相似的流程。顯然，凍乾產品或冷凍藥品有細微差別。我認為我們的 CF 產品中存在一些特定的成分，確切的成分與我們目前用於疫苗的成分不同。

So because of that, there is a know-how or a text transfer process that we have to undergo. But we're confident that that text transfer process is going to be just fine and they're capable of making our drug substance. And ultimately, you asked a question a little bit about fill finish, they are building out not just drug substance capabilities, but also drug product and final fill finish capabilities as well. And because of that, we're going to be leveraging our partners.

因此，我們必須經歷專有技術或文字傳輸過程。但我們相信，文字傳輸過程會很好，他們有能力製造我們的原料藥。最後，您問了一個關於填充完成的問題，他們不僅正在建立原料藥能力，而且還在建立藥品和最終填充完成能力。正因為如此，我們將利用我們的合作夥伴。

So the product produced for CF in Japan will be the final commercial product, correct?

那麼日本為CF生產的產品將是最終的商業產品，對嗎？

Yes, that would be the vision of the, yes.

是的，這就是我們的願景，是的。

Okay. And then as far as capacity, I guess the question is, what about OTC? Is that something you would consider transferring over there or is there a reason you are deciding not to do that? Is it a capacity question?

好的。然後就容量而言，我想問題是，OTC 怎麼樣？您是否會考慮將其轉移到那裡，或者您是否有理由決定不這樣做？是容量問題嗎？

It's rare to do a small amount, so.

少量做的很少見，所以。

We can handle that with our current partners. Just the demand for the amount of cystic fibrosis, mRNA that's going to be required is pretty substantial as I articulated early, on a year-over-year basis of 17 kilogram, that's a lot of mRNA. And as you know, ARCALIS has capacity up to five kilograms right now. So, and so certainly there's an opportunity to potentially expand that as we are able to achieve some clinical success with the CF program.

我們可以與現有的合作夥伴一起處理這個問題。正如我之前所說，囊性纖維化所需的 mRNA 數量相當可觀，比去年同期為 17 公斤，這是大量的 mRNA。如您所知，ARCALIS 目前的容量可達 5 公斤。因此，當然有機會擴大這一範圍，因為我們能夠透過 CF 計畫取得一些臨床成功。

And then the last one is, so you have the 4 million doses that you're shipping over there, and then you said another half a million that's going to be made locally in Japan. So are they basically, and then at some point, they're all going to go into the channel and there may be some overlap potentially. Are they all going to kind of look indistinguishable from a labeling, branding perspective?

最後一個是，你有 400 萬劑運往那裡，然後你說另外 50 萬劑將在日本本地生產。它們基本上也是如此，然後在某個時候，它們都會進入通道，並且可能存在一些潛在的重疊。從標籤、品牌的角度來看，它們看起來都沒有什麼不同嗎？

Well, they all have the same label. Yes, the label is uniform. And so the excitement here is that, ARCALIS is now in the process of producing the KOSTAIVE vaccine. And that's important because as you know, the Japanese government has given ARCALIS $165 million to help construct that facility. So it's a very strategic plant, not only for the Japanese people, but the government to protect the people in any future pandemics that should arise. And so that I think is why the people over there are very excited about this opportunity.

好吧，它們都有相同的標籤。是的，標籤是統一的。令人興奮的是，ARCALIS 目前正在生產 KOSTAIVE 疫苗。這很重要，因為如您所知，日本政府已向 ARCALIS 提供 1.65 億美元來幫助建設該設施。因此，它是一個非常具有戰略意義的工廠，不僅對日本人民，而且對政府來說，在未來可能出現的任何流行病中保護人民。所以我認為這就是為什麼那裡的人對這個機會感到非常興奮。

And one thing to correct Yigal, the 4 million has already been shipped. I just wanted to make sure that was clear.

還有一件事需要糾正 Yigal，400 萬已經出貨了。我只是想確保這一點清楚。

Yeah. Understood. Thank you.

是的。明白了。謝謝。

And with no further questions holding at this time, I'll turn the conference back to Joe Payne for any additional or closing remarks.

由於此時沒有進一步的問題，我將把會議轉回喬·佩恩（Joe Payne）進行補充或結束語。

Hey, thanks everyone for participating on the call. If there's any remaining questions, please don't hesitate to reach out to our team and we'll get back to you as soon as we can. And thanks and good night.

嘿，感謝大家參與電話會議。如果還有任何疑問，請隨時聯絡我們的團隊，我們會盡快回覆您。謝謝，晚安。

Thank you. Ladies and gentlemen, I will conclude today's program. We thank you for your participation. You may disconnect at any time.

謝謝。女士們、先生們，今天的節目就到此結束。我們感謝您的參與。您可以隨時斷開連線。