Trevi Therapeutics Inc (TRVI) 2025 Q3 法說會逐字稿

Than everyone. Good afternoon and welcome to the Trevi Therapeutics 3rd quarter 2025 earnings conference call. (Operator instructions).

比所有人都強。下午好，歡迎參加 Trevi Therapeutics 2025 年第三季財報電話會議。（操作說明）

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form 10k which the company filed with the SEC this afternoon. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so if.

由於各種重要因素的影響，實際結果可能與這些前瞻性聲明所指出的結果有重大差異，這些因素包括公司今天下午向美國證券交易委員會提交的最新季度報告（10-K 表格）風險因素部分中討論的因素。此外，任何前瞻性陳述僅代表本公司截至今日的觀點，不應被視為代表本公司在任何後續日期的觀點。雖然公司未來可能會選擇更新這些前瞻性聲明，但公司明確聲明不承擔任何更新義務。

Its views change. I would now like to turn the conference over to Jennifer Good, Trevi's President and CEO. Please go ahead.

它的觀點會改變。現在我謹將會議交給 Trevi 的總裁兼執行長 Jennifer Good。請繼續。

Good afternoon and thank you for joining us for our 3rd quarter 2025 earnings call and business update. Joining me today on this call are my colleagues, Dr. James Cassella, our Chief Development Officer, and Farrell Simon, our Chief Commercial Officer. I will make some comments on the business and financial results, then the team is happy to answer any questions you may have.

下午好，感謝各位參加我們2025年第三季財報電話會議和業務更新。今天和我一起參加電話會議的是我的同事，首席發展官詹姆斯·卡塞拉博士和首席商務官法雷爾·西蒙。我將對業務和財務表現做一些評論，之後團隊很樂意回答您可能提出的任何問題。

The first half of this year was a major inflection point for Trevi, with positive data readouts in both the coral trial for chronic cough in patients with idiopathic pulmonary fibrosis or IPF, and the river trial for patients with refractory chronic cough or RCC. We recently presented these results at CHS, and it was great to see the interest from leading thought leaders and community pulmonologists.

今年上半年是 Trevi 的一個重要轉折點，珊瑚試驗（用於治療特發性肺纖維化或 IPF 患者的慢性咳嗽）和河流試驗（用於治療難治性慢性咳嗽或 RCC 患者）均取得了積極的數據結果。我們最近在 CHS 上展示了這些結果，很高興看到領先的思想領袖和社區肺科醫生對此表現出濃厚的興趣。

As a result of these strong data, we were able to raise approximately $115 million in June, giving us cash runway into 2028 and an ability to execute on the next clinical studies for each indication. It is an exciting place to be in our journey, and we have not wasted any time in moving forward. Let me provide a brief update on what the team has been up to in each of our chronic cough indications.

由於這些強勁的數據，我們在 6 月籌集了約 1.15 億美元，使我們有現金儲備維持到 2028 年，並有能力針對每項適應症進行下一階段的臨床研究。這是我們旅程中令人興奮的一個階段，我們沒有浪費任何時間向前邁進。讓我簡單介紹一下我們的團隊在治療各種慢性咳嗽疾病方面所做的工作。

We have recently completed a couple of important phases one studies to advance our IPF cough program. The FDA requested we conduct a drug-drug interaction study looking at any potential PK interactions when nalbuphine is co-administered with pirfenidone or nintedanib, which are antifibrotics and the standard of care taken by patients with IPF and other progressive fibrotic diseases.

我們最近完成了幾項重要的第一階段研究，以推進我們的特發性肺纖維化咳嗽治療方案。FDA 要求我們進行一項藥物交互作用研究，以考察納布啡與吡非尼酮或尼達尼布（均為抗纖維化藥物，也是 IPF 和其他進行性纖維化疾病患者的標準治療藥物）共同給藥時可能存在的任何藥物動力學交互作用。

We recently received the data from this study, and we are pleased that there were no clinically meaningful changes in the pharmacokinetics of any of the drug combinations used in this study. We will publish these data in the future, but we did not see anything that will impact the dosing in our phase 3 program. We also made good progress on our title study, which is assessing respiratory function and safety of nalbuphine in IPF patients. Recall, this is a study requested by the FDA to investigate if there were any potential signs of respiratory depression in patients with IPF following dosing with nalbuphine. The IPF patients in the study were housed in clinic for 10 days and given increasing dose of drug while having their oxygen, carbon dioxide levels, and respiration rate assessed for periods of time.

我們最近收到了這項研究的數據，我們很高興地看到，本研究中使用的任何藥物組合的藥物動力學都沒有出現具有臨床意義的變化。我們將在未來公佈這些數據，但我們沒有發現任何會影響我們3期臨床試驗劑量的因素。我們在主研究方面也取得了良好進展，該研究旨在評估納布啡對特發性肺纖維化患者的呼吸功能和安全性。請記住，這是一項由 FDA 要求進行的研究，旨在調查 IPF 患者服用納布啡後是否出現任何潛在的呼吸抑制跡象。研究中的 IPF 患者在診所接受 10 天的治療，並逐漸增加藥物劑量，同時定期評估其氧氣、二氧化碳水平和呼吸頻率。

A planned review of data by an external safety review committee in a sentinel cohort of patients concluded that there were no safety signals in the study to date. As a result, the committee gave approval to complete enrolment for the study. We will include the available data for both the DDI and respiratory safety studies in the end of phase two meeting package.

外部安全審查委員會對一組哨點患者的數據進行了計劃審查，結論是迄今為止該研究中沒有出現任何安全信號。因此，委員會批准完成該研究的招募工作。我們將把 DDI 和呼吸安全性研究的可用資料納入第二階段會議結束資料包。

As for the end of phase 2 meeting, we expect to request that meeting in the 4th quarter of this year. The key points we are looking to discuss with the FDA are to gain alignment on the phase 3 program for chronic cough in patients with IPF. Get their input on the phase 3 study design and other parameters of the protocol, as well as agree upon any other NDA enabling work which needs to be completed. In parallel, the clinical team has been preparing to initiate the phase 3 program in the first half of next year and is busy lining up key vendors and identifying sites for these global studies.

至於第二階段結束會議，我們預計將在今年第四季提出召開該會議的請求。我們希望與 FDA 討論的關鍵點是，就 IPF 患者慢性咳嗽的 3 期臨床試驗項目達成一致意見。徵求他們對 3 期研究設計和其他方案參數的意見，並就任何其他需要完成的 NDA 準備工作達成一致。同時，臨床團隊一直在準備在明年上半年啟動 3 期臨床試驗項目，並忙於聯繫關鍵供應商和確定這些全球研究的地點。

We have also been preparing for a study in other non-IPF interstitial lung diseases, or ILD. This population will include non-IPF ILD patients that have lung fibrosis and chronic cough. We estimate there are approximately 228,000 of these patients. With 50% to 60% having uncontrolled cough. This more than doubles the market opportunity of IPF chronic cough, and these patients are primarily seen by the same pulmonologists that the IPF patients. This keeps our clinical and commercial efforts efficient and creates synergies. We plan to request a meeting with the FDA after we align on the IPF Pivotal Program to discuss our study design and protocol for this syndication as well. Once we have FDA input, we will be prepared to initiate this study.

我們也準備對其他非特發性肺纖維化間質性肺病（ILD）進行研究。此族群包括患有肺纖維化和慢性咳嗽的非特發性肺纖維化間質性肺病患者。我們估計這類患者約有 228,000 人。其中50%至60%的人咳嗽不止。這使得 IPF 慢性咳嗽的市場機會增加了一倍以上，而且這些患者主要由與 IPF 患者相同的肺部醫師診治。這可以提高我們臨床和商業工作的效率，並創造協同效應。我們計劃在就 IPF 關鍵性項目達成一致後，請求與 FDA 會面，討論我們針對此次聯合研究的研究設計和方案。一旦獲得FDA的回饋，我們將準備啟動這項研究。

Finally, we have been working on the next study in refractory chronic cough. We expect that study to be a phase 2B parallel arm dose ranging study and are planning to initiate that study in the first half of next year. We are drafting the protocol and identifying sites for this study as well. So, as you can see, there's a lot of planning going on at Trevi, as well as preparation work to align with the regulatory authorities and initiate multiple trials in the first half of next year. This takes time to ensure that we get these trials right. We will provide updates on next steps as we gain alignment and have line of sight to study starts.

最後，我們一直在進行下一項關於難治性慢性咳嗽的研究。我們預計該研究將是一項 2B 期平行組劑量範圍研究，並計劃於明年上半年啟動研究。我們正在起草研究方案，並確定研究地點。所以，正如你所看到的，Trevi 正在進行大量的規劃工作，以及與監管機構協調並於明年上半年啟動多項試驗的準備工作。我們需要時間來確保這些試驗順利進行。我們將根據情況調整下一步計劃，並在確定方案後開始研究。

I will now provide a quick review of the financial results for the quarter. The full financial results for the three months ended September 30, 2025 can be found in our press release issued ahead of this call and our 10 which was filed with the SEC today after the market closed.

接下來我將簡要回顧本季的財務表現。截至 2025 年 9 月 30 日止三個月的完整財務業績可在本次電話會議之前發布的新聞稿以及今天市場收盤後向美國證券交易委員會提交的第 10 號文件中找到。

For the third quarter of 2025, we reported a net loss of $11.8 million compared to a net loss of $13.2 million for the same quarter in 2024. R&D expenses decreased to $10.1 million during the third quarter of 25 from $11.2 million in the same quarter last year. The reduction was primarily due to decreased clinical trial work in which those trials were actively enrolling in the prior year and reported data in the first half of this year.

2025 年第三季度，我們報告淨虧損 1,180 萬美元，而 2024 年同期淨虧損為 1,320 萬美元。2025年第三季研發費用從去年同期的1,120萬美元減少到1,010萬美元。減少的主要原因是臨床試驗工作量減少，這些試驗在前一年積極招募受試者，並在今年上半年報告了數據。

This was partially offset by increased costs related to our recently completed phase 1 studies and personnel and related expenses.

這部分被近期完成的第一階段研究以及人員和相關費用增加所抵銷。

G&A expenses increased to $3.8 million during the quarter, third quarter of 2025 compared to $2.9 million in the same quarter of last year, primarily due to an increase in professional fees and personnel and related expenses. The increased professional fees were primarily due to increased costs as we continue to prepare for compliance with SO 404B regulations.

2025 年第三季度，一般及行政費用增至 380 萬美元，去年同期為 290 萬美元，主要原因是專業費用、人員及相關費用增加。專業費用的增加主要是由於我們在繼續準備遵守 SO 404B 法規的過程中成本增加所致。

As of September 30, 2025, our cash and investments totalled approximately $195 million. Our cash and investments give us cash runway into 2028, subject to finalizing the development for each of our indications. We expect to be able to fund two phase 3 trials of Haduvio for the treatment of chronic cough in patients with IPF, along with a long-term extension for those trials. Our planned phase 2B3 trial in chronic cough in patients with non-IPF ILD, our next trial in patients with RCC, and our ongoing phase 1 supportive studies.

截至 2025 年 9 月 30 日，我們的現金和投資總額約為 1.95 億美元。我們的現金和投資足以支撐我們到 2028 年的資金周轉，但前提是我們的每項適應症的開發都能最終完成。我們預計能夠資助兩項針對特發性肺纖維化 (IPF) 患者慢性咳嗽的 Haduvio 3 期試驗，以及這些試驗的長期擴展。我們計劃進行針對非 IPF ILD 患者慢性咳嗽的 2B3 期試驗，接下來將進行針對 RCC 患者的試驗，以及正在進行的 1 期支持性研究。

So in closing, Trevi is positioned with strong data in 2 serious chronic cough conditions and is preparing to advance into the next stage of development for each of the 3 chronic cough indications. Chronic cough is a debilitating condition for which there are currently no FDA approved therapies. Also, the company is financially strong, with enough cash to complete the next stage of development work to potentially advance these therapies closer to the patient.

綜上所述，Trevi 在 2 種嚴重的慢性咳嗽疾病方面擁有強大的數據支持，並準備針對 3 種慢性咳嗽適應症推進到下一個開發階段。慢性咳嗽是一種令人痛苦的疾病，目前尚無FDA核准的治療方法。此外，該公司財務狀況良好，並擁有足夠的現金來完成下一階段的研發工作，這有可能使這些療法更接近患者。

We believe we are well positioned to execute our strategy and create meaningful shareholder value over the next couple of years. This concludes my prepared remarks. Jim Farrell and I are now happy to answer your questions. I will turn the call back over to the operator for Q&A.

我們相信，我們已做好充分準備，在未來幾年內執行我們的策略，並為股東創造有意義的價值。我的發言稿到此結束。吉姆法雷爾和我現在很樂意回答你們的問題。我將把電話轉回給接線生進行問答環節。

We will now begin the question-and-answer session.(Operator instructions).

現在開始問答環節。 （操作員說明）

Ryan Deschner from Raymond James.

來自 Raymond James 的 Ryan Deschner。

Hi, thank you very much for the question. Have you narrowed down more of what inclusion exclusion criteria you would target for the non-ITF ILD study, maybe in terms of, in particular, what constitutes chronic cough in those studies, and would you exclude any ILDs from an initial study in the space off the bat? Thank you.

您好，非常感謝您的提問。您是否進一步縮小了非 ITF ILD 研究的納入和排除標準範圍？例如，特別是關於這些研究中慢性咳嗽的定義，以及您是否會一開始就將該領域的 ILD 排除在初始研究之外？謝謝。

Hi, Ryan, this is Jim. So, thanks for the question. So, the, we had some good discussions with our KOLs for the non-IPF ILD study. I think you can imagine that there's going to be a lot of similarity in the underlying lung disease. We'll define that in a certain way. Chronic cough, I think we're going to go in with the standard criteria. Typically, we look at some minimum.

你好，瑞恩，我是吉姆。謝謝你的提問。所以，我們與 KOL 就非 IPF ILD 研究進行了一些很好的討論。我想你可以想像，它們的潛在肺部疾病會有許多相似之處。我們將以某種方式來定義它。慢性咳嗽，我想我們會按照標準診斷標準進行診斷。通常，我們會考慮一些最低標準。

Amount of cough in terms of maybe 10 coughs per hour. So, it'll be very consistent with what we're looking at in the rest of our program. So, I think that those are narrowing down rather nicely. I think the important point to remember about that type of trial is that while there's going to be patients with lots of other comorbid conditions, we're really focusing on the entry criteria. Being related to the amount of cough that they have and the amount of lung damage, lung fibrosis that they have. So those are going to be the defining features for the inclusion, and then there'll be other things to manage around their comorbid conditions.

咳嗽次數大概為每小時10次。所以，這與我們節目其他部分的研究方向非常一致。所以，我認為這些範圍正在逐步縮小。我認為關於這類試驗需要記住的重要一點是，雖然會有很多其他合併症的患者，但我們真正關注的是入組標準。這與他們的咳嗽程度和肺部損傷、肺纖維化的程度有關。所以這些將是納入標準的決定性特徵，然後還需要處理他們的合併症等其他問題。

And Jim, anything we're carving out.

還有吉姆，我們正在努力打造的任何東西。

At this point in time, we're not really carving out anything. We're going to base it on those, basic criteria. So of course, it's a broad swath of conditions. And as we get closer to that, inclusion, or it's closer to defining that protocol a little bit more in depth, we may carve out one or two, but for the most part, it's going to be based on lung disease and amount of cough.

目前，我們還沒有真正著手製定任何計劃。我們將以此為依據，制定基本標準。所以，這當然涵蓋了範圍很廣的一系列情況。隨著我們越來越接近納入標準，或越來越接近更深入定義該方案，我們可能會排除一兩個例外，但大多數情況下，這將取決於肺部疾病和咳嗽的程度。

Excellent. Thank you very much. And maybe quickly just on the DDI study, would you anticipate, needing to do any more studies like that for a trial like this or subsequent trials outside of IPF, chronic cough and RCC?

出色的。非常感謝。或許可以快速地就 DDI 研究而言，您是否預計，對於此類試驗或 IPF、慢性咳嗽和 RCC 以外的後續試驗，是否需要進行更多類似的試驗？

Yeah, so that's great, Ryan. Thanks. So, the study we got done was a DDI looking at our drug with [prophenidone and tenib] as the key antifibrotics in this space. There will be other DDI studies that will be having to do based on the mechanism of drug metabolism. We are metabolized by shift primarily the 2C9, 2C19 species. So, there will be a DDI looking at probably a 2C9 inhibitor. These are things that we'll talk with the FDA about, but it's, it is expected that we will have to do a couple more phase one studies and at least one more DDI study.

是啊，那太好了，瑞恩。謝謝。因此，我們完成的研究是一項藥物交互作用研究，研究對像是該領域的主要抗纖維化藥物[丙苯尼酮和替尼布]。根據藥物代謝機制，還需要進行其他藥物交互作用研究。我們主要透過轉移代謝 2C9、2C19 物種。所以，將會有一項 DDI 研究，可能針對的是 2C9 抑制劑。這些都是我們會和FDA討論的事情，但預計我們還需要進行幾項一期臨床試驗和至少一項藥物交互作用（DDI）試驗。

Thank you very much.

非常感謝。

Annabel Samimy from Stifel.

來自 Stifel 的 Annabel Samimy。

Hi, thanks for taking my question. I was just wanting to clarify for the respiratory study, you have, you had interim results from the DSMB saying that you didn't have any issues. Do you need to complete that study before you have the end of phase two meeting with FDA and. Is there any other, hurdle that you need to get past for that specific meeting, and then separately, if you could just share a little bit of the feedback that you've been hearing from chess, the chess meeting at this point, how are the pulmonologists looking at this and how do you, start thinking about targeting, the market that you're that you're looking at? Thanks.

您好，感謝您回答我的問題。我只是想就呼吸系統研究進行確認，你們已經從資料安全監察委員會 (DSMB) 獲得了中期結果，表明你們沒有遇到任何問題。你需要在與FDA召開二期臨床試驗結束會議前完成這項研究嗎？您在參加那次會議之前是否還有其他需要克服的障礙？另外，您能否分享一下您目前從國際象棋會議中聽到的一些回饋？肺科醫師是如何看待這個問題的？您又是如何開始考慮如何瞄準您所關注的市場？謝謝。

Sure. Hi, Annabelle. So, on Tidal, we had a sentinel cohort of 4 subjects, that we completed, and the plan was to have our data monitoring committee review those subjects. That all went fine. There was no safety issues identified, so we continued on. To answer your question. We will have the available data when we submit the package. We don't have to complete that study before we submit for the end of phase two meeting, and, our intention is that we'll have all the data by the time we have the meeting.

當然。你好，安娜貝爾。因此，在 Tidal 上，我們完成了一個由 4 名受試者組成的哨兵隊列，計劃由我們的數據監測委員會審查這些受試者。一切都很順利。未發現安全性問題，因此我們繼續前進。回答你的問題。我們將在提交資料包時提供可用資料。我們不必在提交第二階段結束會議之前完成這項研究，我們的目標是在會議之前獲得所有數據。

Yeah, and I'll just jump in at the beginning of the second question, and then Farrah, I'll have you take on how it targets the market. But I think Annabelle, we presented, we had our data presented at both chest and ERS.

是的，我會在第二個問題開頭就插話，然後法拉，我想請你談談它是如何瞄準市場的。但我認為安娜貝爾，我們已經在胸腔科和ERS會議上展示了我們的數據。

It was very well attended. We had one poster at ERS. You could barely even get near the poster. A lot of interest. It was interesting. There was a lot of our investigators that were very interested in the full data, and they've got their patients, coming back to them wondering when we're going to start our next trial. So I would say people understand cough is a big problem and there's been a lot of work done in antifibrotics, but there really hasn't been a lot of work done on things that matter day to day to the patient.

出席人數非常多。我們在ERS大會上展示了一張海報。你幾乎都無法靠近海報。引起了廣泛關注。很有意思。我們有很多研究人員對完整的數據非常感興趣，他們的病人也回來詢問我們何時開始下一次試驗。所以我覺得大家都明白咳嗽是個大問題，抗纖維化藥物方面也做了很多研究，但是對於患者日常生活中真正重要的問題，研究卻不多。

So we're getting a lot of attention in our sessions. The data's gotten a lot of attention, and we also hosted a reception one night that was very well attended by US investigators interested in getting into our study. So really encouraging. Jim and I were both there and quite busy the whole time. I think so I'll let you take on sort of based on the feedback how you might be thinking about targeting the market with any of the feedback.

所以我們的工作受到了很多關注。這些數據引起了廣泛關注，我們也舉辦了一場招待會，許多對參與我們的研究感興趣的美國研究人員都來參加。真是令人鼓舞。吉姆和我當時都在場，全程都很忙。我想我會讓你根據回饋意見來決定如何利用這些回饋意見來瞄準市場。

Yeah, thanks, Annabelle, for the question. When we look at the market, we do need to raise the burden of the disease, and that's work that's undergoing that we're continuing and we'll launch next year. There's also just targeting in terms of how we look at segmenting this market. It's work in which we'll start next year just to make sure that we have appropriately sized our field force to target the key prescribers in this area. So that's some of the work and then we're continuing to always do physician and payer research to understand how our new target product profile based on the positive poll results are seen by physicians and payers within this space.

好的，謝謝安娜貝爾的提問。當我們審視市場時，我們確實需要提高疾病負擔，這是我們正在進行的工作，我們將繼續這項工作，並將於明年啟動。在市場區隔方面，還有目標定位的問題。這項工作我們將於明年啟動，以確保我們擁有足夠規模的現場服務隊伍，以便瞄準該地區的關鍵處方醫生。以上是部分工作內容，接下來我們將繼續對醫生和支付方進行研研，以了解基於積極的民意調查結果而製定的新目標產品概況在該領域內的醫生和支付方是如何看待的。

Great, thank you.

太好了，謝謝。

Thanks, Annabelle.

謝謝你，安娜貝爾。

Lilian Gerchel with Oppenheimer.

莉蓮·格切爾與奧本海默。

Oh, great. Thanks for the update and taking the questions. Just a couple, I joined a little bit late, so my apologies if you may have covered, but as you head into the end of phase two meeting, Jennifer, are there any particular questions or issues that you would like to address or clarity on? And I also want to ask on the drug-drug interaction side, is there any need for Trevi to run, interaction studies in patients who may be on other opioids commonly? Thank you.

哦，太好了。感謝您提供最新資訊並回答問題。我來晚了一點，所以如果你們已經講過了，請見諒。 Jennifer，在第二階段會議即將結束之際，您還有什麼特別的問題或事項需要說明或澄清嗎？另外，關於藥物交互作用方面，Trevi 是否有必要對可能正在服用其他鴉片類藥物的患者進行交互作用研究？謝謝。

Wait, this is Jim. So, in terms of the end of phase two meeting, our standard questions are going to be related to the protocol design, end points, or duration of the study, really nuts and bolts around the phase 3. We'll be submitting a full final draft protocol to them, so they'll have the protocol, with them in hand. And we will guide some of the more important questions regarding the design, patient inclusion, exclusion criteria, our statistical approach, pretty basic things that are really important to narrow down at this meeting. So we will have absolute clarity on what we need to do for the phase 3, coming out of that.

等等，這是吉姆。因此，在第二階段結束的會議上，我們的標準問題將與方案設計、終點或研究持續時間有關，實際上是與第三階段相關的具體細節。我們將向他們提交一份完整的最終版協議草案，以便他們手上能拿到協議。我們將就設計、患者納入、排除標準、統計方法等一些更重要的問題進行指導，這些都是一些非常基本的問題，在本次會議上需要重點討論。因此，在那之後，我們將對第三階段需要做的事情有非常清晰的了解。

Safety database size too is an important one.

安全資料庫的大小也是一個重要因素。

Safety database size, we'll be discussing the extent of, any long-term data collection. And we'll also be, as we talked about the DDI study and, we did talk that we may need to do some more work in the phase one world on wrapping up things for the NDA submission. We will probably do another drug-drug interaction study. That encompasses our mechanism of drug metabolism, which is through SIP systems and 2C9, 2C19 in particular. So, we'll be asked to do a drug-drug interaction study with drugs that are inhibitors of that system to understand what the effects are on pharmacokinetics. There might be some other phase one studies that we're anticipating that we will discuss with the FDA at the end of phase two meeting as well.

我們將討論安全資料庫的規模，以及任何長期資料收集的範圍。而且，正如我們之前討論的DDI研究，我們也談到，我們可能需要在第一階段做一些工作，以完成NDA提交的相關事宜。我們可能會再做一項藥物交互作用研究。這涵蓋了我們的藥物代謝機制，即透過 SIP 系統，特別是 2C9、2C19。因此，我們將被要求對該系統抑制劑藥物進行藥物交互作用研究，以了解其對藥物動力學的影響。我們預計還會進行一些其他的第一階段研究，我們將在第二階段會議結束時與 FDA 討論這些研究。

I would just add though, Leland, and I think you specifically asked about other opioids. They are contraindicated. We have excluded them because, as our mechanisms immune antagonists. So if you're on other opioids, it will put you into opioid withdrawal, which is obviously super helpful from the addiction side and labelling side, but we do contraindicate that in our trials and will be in our label.

不過我還要補充一點，萊蘭，而且我想你特別問到了其他鴉片類藥物。它們之間存在著禁忌。我們已將它們排除在外，因為它們是我們的機制免疫拮抗劑。所以，如果你正在服用其他鴉片類藥物，它會讓你出現阿片類藥物戒斷症狀，這顯然對成癮和標籤標註方面非常有幫助，但我們在試驗中明確指出這是禁忌的，並且會在我們的標籤中註明。

Right, helpful. Thanks very much.

好的，很有幫助。非常感謝。

Yeah, thank you, Leland.

是的，謝謝你，利蘭。

Judah Farmer with Morgan Stanley.

摩根士丹利的猶大法默。

Yeah, hi guys, thanks for taking the questions. Maybe could you help us with the latest thinking on potential to incorporate the non-IPF ILDs into the phase 3 program for IPF. Will you get any clarity on that at the end of phase two, do you think, or do you have to wait for that subsequent interaction and then what are your thoughts on.

嗨，各位，謝謝你們回答問題。您能否幫助我們了解將非 IPF ILD 納入 IPF 第三階段治療方案的最新思路？你認為在第二階段結束時，這個問題會得到明確的答案嗎？還是需要等到後續的互動才能知道？到那時你又會作何感想？

Launching with both indications in the same label versus SNDA, and then secondarily, obviously very high level, but any thoughts on changes in CER leadership and impacts of the programs, thanks.

與SNDA相比，在同一標籤上同時推出兩種適應症，其次，顯然是高階的，但對於CER領導層的變化和專案的影響，有什麼想法嗎？謝謝。

And I'm just going to comment on strategy. We could probably both do this, but I think Judah, we made a decision, that we're going to go in with sort of our strongest foot forward and do the end of phase two meeting. Jim's got a lot of data, robust data. We want the FDA to catch up with where we are, all the studies we've done, the data we've generated, and we will tease up there that ours. Broader program includes both RCC but importantly non-IPF ILD which we think shares a common biology.

我只想談談戰略方面。我們倆可能都能做到，但我認為猶大，我們已經決定，我們要以最強的姿態進入第二階段的最後階段會議。吉姆有很多數據，而且是可靠的數據。我們希望 FDA 能夠了解我們目前的進展，了解我們已經完成的所有研究和我們產生的數據，然後我們會向他們展示我們的成果。更廣泛的項目不僅包括 RCC，更重要的是包括非 IPF ILD，我們認為它們具有共同的生物學特性。

So we will tee that up but you only get one hour in this meeting and we don't want to get distracted debating non-IPF ILD there because to Jim's point, we need to walk out with clear guidance on our phase 3 program. So really trying to protect that. Keep it whole as soon as we feel we have alignment with the agency, we're going to be prepared to submit a protocol and non-IPF ILD and request a Type C meeting.

所以我們會做好準備，但這次會議只有一小時，我們不想在會議中分心討論非 IPF ILD，因為正如 Jim 所說，我們需要帶著明確的第三階段計劃指導方針離開。所以真的想保護它。一旦我們感覺與該機構達成一致，我們將準備提交一份方案和非 IPF ILD，並請求召開 C 類會議。

Hopefully that's a pretty easy ask coming off the heels of the IPF and the phase two. So that was sort of a strategy point because we could have jumped in earlier but thought we wanted our strongest foot forward. I mean, as far as the sort of cedar change in leadership, and I'll let Jim add any colour as well. I mean, obviously new person named this week, oncology person.

希望在 IPF 和第二階段之後，這個要求能夠比較容易實現。所以這算是一種策略，因為我們本來可以更早介入，但我們想先展現最強的實力。我的意思是，就領導階層這種「雪松」式的更迭而言，我也會讓吉姆補充一些細節。我的意思是，很明顯，本週新任命了一位腫瘤科醫生。

I don't know how much that's really affecting the divisions we've had. I mean, baffling to me, finally feedback on time. Clear communications. I don't know how the FDA is holding it together. Kudos to them. So, I don't know how much those levels are affecting things when you're in a clinical trial mode. I'm sure at the point in time they look at your NDA, it does, but it hasn't seemed to impact what we're doing. I don't know, Jim, do you have anything?

我不知道這究竟對我們之間的分歧產生了多大影響。我的意思是，讓我感到困惑的是，終於及時得到了回饋。清晰的溝通。我不知道FDA是怎麼維持現狀的。向他們致敬。所以，我不知道在臨床試驗模式下，這些水平會對結果產生多大影響。我相信他們到時候肯定會查看你的保密協議，但似乎並沒有對我們的工作產生影響。吉姆，我不知道，你有什麼嗎？

No, nothing to add to that other than. I think the surprise factor of how responsive they've been is, has been high on my list. It's like this is very unusual for me to get this kind of responsiveness, so very pleased about that.

不，沒什麼要補充的了。我覺得他們如此迅速的反應速度讓我感到非常驚喜，這一點一直讓我印象深刻。我很少得到這樣的回复，所以非常高興。

Yeah.

是的。

Great.

偉大的。

Thank you, Judah.

謝謝你，猶大。

Serge Belanger from Needham & Company.

來自 Needham & Company 的 Serge Belanger。

Hi, good afternoon. I think in the past you've discussed the potential of Haduvio being eligible for orphan drug exclusivity and IPF COO.

您好，下午好。我認為您過去曾討論過 Haduvio 有可能獲得孤兒藥獨佔權和 IPF COO 資格。

Just curious if you have any updated thoughts on that and whether that's something you will seek, like an orphan drug designation in the upcoming, and a phase two meeting with FDA. Thanks.

我只是好奇您對此是否有任何最新的想法，以及您是否會尋求這方面的進展，例如在即將到來的階段申請孤兒藥資格認定，以及與FDA進行二期臨床試驗。謝謝。

Jim's laughing because he made me promise we are going to request orphan drug for IPF. I do always warn people that, I don't want people to put too much in that. Although I IPF has gotten orphan drugs. This is cough in IPF, and cough is a broad problem, so. We'll see what they have to say.

吉姆笑了，因為他要我答應我們會申請治療特發性肺纖維化的孤兒藥。我總是提醒人們，我不希望人們在這方面投入太多精力。雖然 IPF 已經獲得了孤兒藥。這是特發性肺纖維化（IPF）引起的咳嗽，而咳嗽本身就是一個常見的問題。我們看看他們怎麼說。

So we will apply. I think it's an answer we should know. Jim made me promise that we wouldn't do that until after we went through our end of phase two meeting. He doesn't want them distracted on any other side questions. So, I think on the heels of end of phase two, we'll go ahead and submit for that and find out their views on Cop and IPF.

所以我們會申請。我認為這是我們應該知道的答案。吉姆要我保證，在我們完成第二階段結束會議之前，我們不會做這件事。他不想讓他們被其他無關問題分散注意力。所以，我認為在第二階段結束後，我們將提交申請，以了解他們對 Cop 和 IPF 的看法。

Got it. Thank you.

知道了。謝謝。

Thank you, sir.

謝謝您，先生。

Roanna Ruiz with Leerink Partners.

Roanna Ruiz 與 Leerink Partners 合作。

Hey, good afternoon, everyone. So, a couple for me, first one is, given the evolving IPF landscape with recent positive data from United Therapeutics Teton study, I was curious, how could that impact how Haduvio fits into the prescribing approach and treatment algorithm of physicians?

大家好，下午好。所以，我有兩個問題。首先，鑑於 IPF 領域不斷發展，以及 United Therapeutics Teton 研究最近公佈的積極數據，我很好奇這會對 Haduvio 在醫生的處方方法和治療方案中的作用產生怎樣的影響？

So, you want to take that or I can as well?

所以，你想拿走那個，還是我也可以？

Yeah, happy to. Thanks, Roanna, for the question.

是的，我很樂意。謝謝羅安娜的提問。

If anything, it probably, it doesn't really change much for us when you think about chronic cough, the high burden of disease among these patients. Physicians look at this as either first- or second-line therapy, and that can be before an antifibrotic or after an antifibrotic is initiated. When you look at the drugs and the new approvals that are already coming to market. They're still slowing the progression of the disease and they're not having a positive impact on the cough, so there's still a very high place for chronic cough therapy and concomitant therapy with these anti-fire products that are on the market or potentially coming to market.

如果有什麼改變的話，那就是，當我們想到慢性咳嗽以及這些患者所承受的沉重疾病負擔時，這對我們來說可能並沒有什麼真正的改變。醫生將此視為一線或二線療法，可以在開始使用抗纖維化藥物之前或之後使用。當你審視那些已經上市的藥物和新核准的藥物。它們仍然能減緩疾病的進展，但對咳嗽沒有積極作用，因此慢性咳嗽治療以及與市面上或可能上市的這些抗火產品聯合治療仍然非常重要。

And so I would just add too, I've heard a lot of discussion about, with improvements in therapies and treatments for patients, it probably just improves the diagnosis, the patient groups will start to grow. I think people are focused on, this disease a little more. Hopefully cough comes to the forefront when we actually have something for treatment. So, it's obviously great for the patient to have options, but I just think overall it probably grows the market as well.

所以我還要補充一點，我聽到了很多關於治療和療法改進的討論，隨著診斷的改進，患者群體將會開始擴大。我認為人們現在對這種疾病的關注度更高了。希望咳嗽問題能在找到有效治療方法時得到重視。所以，對病人來說，有許多選擇當然是好事，但我認為從整體來看，這也可能促進市場成長。

Yeah, makes sense. And a quick follow-up about the title study. What do you hope to see in the results in terms of a best case scenario now that you can complete enrolment and any sort of thoughts on how that might impact the end of phase two discussion with the FDA?

嗯，有道理。最後，我想快速跟進標題研究。現在您已經完成了受試者招募，您希望在最佳情況下看到怎樣的結果？您認為這可能會對與FDA的第二階段討論產生什麼影響？

Yeah, hi, this is Jim. So, we are looking at basic respiratory function, CO2, and respiration rate. So, the FDA was interested in a study like this just to make sure that we don't have any blatant signals regarding respiratory depression. So, we're taking a very fundamental approach on key respiratory parameters and looking at those. The ideal outcome for the study and the data has been great so far is that there's no findings here.

嗨，我是吉姆。所以，我們正在研究基本的呼吸功能、二氧化碳和呼吸頻率。因此，FDA 對此類研究很感興趣，以確保我們沒有發現任何有關呼吸抑制的明顯跡象。所以，我們採取了一個非常基礎的方法，研究關鍵的呼吸參數。這項研究的理想結果，以及目前為止的數據，就是沒有發現任何問題。

There would be no findings, meaning that there's no changes on any of those parameters. We are dosing at night, looking at these IPF subjects while they are asleep, which is considered a conservative way, most sensitive approach to this. So that's the nature of the study to really pull out if there's anything there. So, obviously, clean results and no impact on the program is the ideal outcome here. Jim.

沒有發現任何問題，這意味著這些參數沒有任何變化。我們選擇在夜間給予這些 IPF 患者給藥，並在他們睡覺時觀察他們的狀況，這被認為是一種保守的方法，也是最敏感的方法。所以這項研究的性質就是要真正找出其中是否有任何有價值的資訊。所以，顯然，理想的結果是結果乾淨利落，並且對專案沒有任何影響。吉姆。

I would just add we've obviously had this in what, 200 people now, IPF patients clinically, and never seen any signal. So, I think this will just sort of go hand in hand with the safety database that they look at as well.

我還要補充一點，我們已經在大約 200 名 IPF 患者身上進行了臨床檢查，但從未發現任何訊號。所以，我認為這會與他們所參考的安全資料庫相輔相成。

Makes sense. Thanks.

有道理。謝謝。

Thanks, Roanna.

謝謝你，羅安娜。

William Wood with B Riley Securities.

William Wood，B Riley Securities公司。

Alright, thanks and thank you for our questions today. So, a couple from us kind of focus on the phase three. It sounds like from what I can tell you, you've essentially got your sort of phase 3 package sort of put together in terms of how you want it. Obviously that's got to be discussed with the FDA and approved or at least agreed upon, but I was just curious if you could walk through sort of maybe what you're thinking.

好的，謝謝，也謝謝大家今天提出的問題。所以，我們幾個主要關注第三階段。聽起來，就我所知，你已經基本上按照你想要的方式，把第三階段的方案製定好了。顯然，這需要與美國食品藥物管理局（FDA）討論並獲得批准或至少達成一致，但我只是好奇您是否可以大致談談您的想法。

Looking at a high level in terms of doses and or timing titration you're looking to take forward and maybe just remind us, are you going to allow patients to use background antifibrotics in the study and will you be looking at biomarker, fibrotic, biomarker improvement within the study? And then lastly, just briefly, would this be conducted in the same, sites that your, other phase twos were, or will you be branching out further?

從劑量和/或時間調整的宏觀層面來看，您希望能推進哪些方面？或許可以提醒我們一下，您是否允許患者在研究中使用背景抗纖維化藥物？您是否會在研究中觀察生物標記、纖維化、生物標記的改善？最後，簡單問一下，這次試驗會在與先前二期試驗相同的地點進行，還是會擴展到其他地點？

Sure, I think I can remember all those.

當然，我想我都能記得。

I got them.

我收到了。

I got them down. So, William, so thanks. This is Jim. So, in terms of doses, we did, coral was a great study for us because we learned a lot from it, including, that was our definitive dose ranging study. So in terms of dose going forward, we did a lot of work over the summer.

我把它們都記下來了。威廉，謝謝你。這是吉姆。所以，就劑量而言，我們確實對珊瑚進行了研究，因為我們從中學到了很多，包括，這是我們最終確定的劑量範圍研究。所以，就未來的劑量而言，我們整個夏天都做了很多工作。

We, interrogated the 54mg and the 108mg dose group and because of the titration up, we were able to determine in, individual subjects and looking at dosing groups that the 108 really didn't add any significant value to the 54mg bid dose. So 54mg BID will be our top dose going forward. The 27mg BID dose is a titration dose. We identified that as a minimum effective dose in the Coral study, so it will not be considered a treatment dose, but it will be considered a titration dose.

我們對 54mg 和 108mg 劑量組進行了調查，由於劑量逐漸增加，我們能夠透過對個別受試者和劑量組的觀察來確定，108mg 劑量實際上並沒有給 54mg bid 劑量增加任何顯著價值。因此，54毫克，每日兩次，將是我們未來的最高劑量。每日兩次，每次 27 毫克的劑量是滴定劑量。我們在 Coral 研究中確定了該劑量為最小有效劑量，因此它不被視為治療劑量，而是被視為滴定劑量。

What we also learned from the Coral study. Is that when we do our titration, as we've done in all of our programs to date, we see that most of the adverse events that we see typical for this compound, which are mostly GI and CNS in nature, most of those come on with the initiation of dosing. So, what we're going to do is extend a little bit further the, once a night dosing under the 27mg dose, go into 27mg BID and then get into our 54mg bid treatment dose. So, we will extend that titration period a little bit to mitigate some of the earlier, side effects that we see with the compound. And just a reminder about the nature of the adverse events that we see with nalbuphine is that we typically see some GI and some CNS. These are typically transient, and these are typically things that you tolerate out over time, and that's why we're going to extend that titration period.

我們也從珊瑚研究中學到了什麼。也就是說，當我們進行滴定時（就像我們迄今為止在所有項目中所做的那樣），我們發現這種化合物的大多數典型不良反應（主要是胃腸道和中樞神經系統方面的不良反應），大多是在開始給藥時出現的。所以，我們要做的就是進一步延長劑量，從每晚一次低於 27 毫克的劑量，增加到每天兩次 27 毫克，然後再增加到每天兩次 54 毫克的治療劑量。因此，我們將稍微延長滴定期，以減輕我們先前觀察到的該化合物的一些副作用。再次提醒大家，納布啡引起的不良反應通常包括一些胃腸道反應和一些中樞神經系統反應。這些通常是暫時的，而且隨著時間的推移，這些情況通常會逐漸消失，所以我們要延長滴定期。

In regards to your question about allowing background antifibrotics, over 80% of our subjects in the coral study were on either [natenib or prophenidone], so yes, we are going to allow approved antifibrotics as background medication.

關於您提出的是否允許使用背景抗纖維化藥物的問題，在珊瑚研究中，超過 80% 的受試者正在服用 [那替尼或普利酮]，因此，是的，我們將允許使用已批准的抗纖維化藥物作為背景藥物。

In terms of biomarkers, we don't have any intention of looking at those, in any, well, we're not going to look at those. And in terms of the sites, if you recall in Coral, we were running that study, that study XS. We will be going back to the more successful sites in that region. And we will also be bringing in a large number of US centres. The great thing about the Pulmonary fibrosis Foundation is that there are over 80, excellent, care, excellent care centres, and we are talking to them about, conducting our trials. So, we will be bringing it in a major way US centres, as well as Canada and Europe.

至於生物標誌物，我們沒有任何研究它們的打算，無論如何，我們都不會研究它們。至於站點方面，如果你還記得 Coral，我們當時正在進行那項研究，那項 XS 研究。我們將重返該地區較為成功的站點。我們還將引入大量美國中心。肺纖維化基金會最棒的地方在於，它擁有 80 多個優秀的護理中心，我們正在與他們洽談，進行我們的試驗。因此，我們將大力將其引入美國市場，以及加拿大和歐洲市場。

Got it. That was very. Helpful. Thank you for all this quick, answering all my questions. Very briefly and lastly, the end of phase two package, once you actually get that submitted and discussed, will you be relaying that to us and or investors, the public or is that just, how will that be, Dispersed I guess.

知道了。那真是太…很有幫助。非常感謝您如此迅速地回答我的所有問題。最後，簡單來說，關於第二階段方案的結束，一旦你們提交並討論完畢，你們會將其傳達給我們、投資者或公眾嗎？還是說，就這麼不了了之，自行分發？

Yeah, no, it's a good question, William. I think typically you do the meeting and then you wait 30 days for the minutes. Usually, you want to wait to see the minutes so that what we think we heard we actually see in writing when we get it. When we have that information, we'll definitely give an update to the street. I mean we probably won't put out a separate press release. I think on one of our earnings calls or some venue we'll use it to update people, but yeah, it's important information for sure.

沒錯，威廉，你問得好。我認為通常情況下，開完會後要等30天才能拿到會議記錄。通常情況下，人們都想等到看到會議記錄後再做決定，這樣我們聽到的內容才能在書面記錄中得到證實。一旦我們掌握了相關信息，我們一定會及時向大家通報最新情況。我的意思是，我們可能不會單獨發布新聞稿。我想我們會在某個財報電話會議或其他場合用這個資訊向大家更新情況，但沒錯，這絕對是重要的資訊。

Got it. Helpful. Thank you very much, and I'll hop back in the queue.

知道了。很有幫助。非常感謝，我會重新排隊。

Okay, thanks, William.

好的，謝謝你，威廉。

Kaveri Pohlman from Clear Street.

來自 Clear Street 的 Kaveri Pohlman。

Hi, good evening. Thanks for taking my questions. So, my first question is about, how well do the current trial match the real-world patients considering things like, the inclusion, exclusion criteria, comorbidities, or use of other drugs. And for future trials for both, IPF and RCC, do you plan to make the eligibility criteria broader to include a more diverse population or will they stay the same?

您好，晚上好。謝謝您回答我的問題。所以，我的第一個問題是，考慮到納入標準、排除標準、合併症或使用其他藥物等因素，目前的試驗與現實世界的患者有多大程度的匹配。對於未來針對 IPF 和 RCC 的試驗，您是否計劃擴大入選標準以納入更多樣化的人群，還是將保持不變？

Yeah, hi, this is Jim. So, we will keep this population for the phase 3 as broad as possible. We are really trying, not to make it strictly a clinical trial population, but we want to keep it broad. So, we are working with the KOLs to really refine our inclusion exclusion criteria to make it definitely more real world. So, we will have few restrictions other than they need to be diagnosed with IPF they need to be, have some other things that make them relatively healthy that they can actually be involved in the study. So, I can promise you that it will be as broad as possible as real life as possible.

嗨，我是吉姆。因此，我們將盡可能擴大第三階段的受試者群體。我們真的想努力不把它變成嚴格意義上的臨床試驗族群，而是希望保持其廣泛性。因此，我們正在與 KOL 合作，真正完善我們的納入和排除標準，使其更加貼近現實世界。所以，除了他們需要被診斷出患有特發性肺纖維化 (IPF) 之外，我們幾乎沒有其他限制；他們還需要具備一些其他條件，使他們相對健康，才能真正參與研究。所以，我可以向你保證，它會盡可能地貼近現實生活，內容也會盡可能地豐富。

Not too much different than our 2B.

與我們的 2B 型差異不大。

Not very much different. In fact, we're actually, we're finding a few things to broaden it from our 2B. We will allow basically, unless something that is going to Interfere with our ability to measure cloth, or we'll have a direct impact on cloth in the trial. Their con meds will be allowed to, for normal. And I don't know if there's any, what else did you, was there anything else that you asked? I think I covered those two things. Okay.

差別不大。事實上，我們正​​在尋找一些東西來擴展我們的 2B。基本上我們會允許，除非有事情會幹擾我們測量布料的能力，或是會對試驗中的布料產生直接影響。他們的藥物將被允許正常使用。我不知道還有沒有其他問題，你還問了什麼其他問題嗎？我覺得我已經把這兩點都講清楚了。好的。

Right. Yeah, that's helpful. And, I also want to understand for the RCC phase 2B trial, do you plan to study the same dosing regimen as it was in the phase 2A or you plan to kind of test QD options also since the drug seems pretty safe?

正確的。是的，這很有幫助。另外，我還想了解一下，對於 RCC 的 2B 期試驗，你們計劃研究與 2A 期相同的給藥方案，還是計劃測試每日一次 (QD) 的方案，因為該藥物似乎相當安全？

Yeah, we're actually going to, probably, eliminate the top 108 dose in that trial and, we will be exploring, QD dosing, once a day dosing, in that trial as well as BID, as well as the BID. So, we'll probably add a 27 qd arm in there because if you recall the data, our 27 BID dose was, about as effective as the two higher doses.

是的，我們實際上可能會取消該試驗中的第 108 個劑量，並且我們將在該試驗中探索每日一次給藥（QD）以及每日兩次給藥（BID）。所以，我們可能會增加一個 27 qd 的劑量組，因為如果你還記得數據的話，我們的 27 BID 劑量與兩個更高的劑量組的效果差不多。

Got it. And maybe just like the last one. So respiratory safety study, it was surprising that the FDA needed that after you showed 200 patients' worth of data, but I still want to understand, do you, will you be assessing long-term effects? Do you need to keep patients on to provide that data or it's not required?

知道了。或許就像上一個。所以，呼吸安全性研究，令人驚訝的是，在你展示了 200 名患者的數據之後，FDA 仍然需要這項研究，但我仍然想了解，你會評估長期影響嗎？是否需要保留患者資訊以提供這些數據，還是並非必須？

So I think the FDA is curious about doing a very specific study. I've been in this situation before where they like to see a more directed controlled study, just rather than collecting adverse events. So, I think it's, their prerogative to ask for a study like this, I think it's going well. I'm sorry, what was the second part?

所以我認為FDA很想進行一項非常具體的研究。我以前也遇到過這種情況，他們更希望看到有針對性的對照研究，而不是只收集不良事件數據。所以，我認為他們有權要求進行這樣的研究，而且我認為研究進展順利。抱歉，第二部分是什麼？

We will do long-term, data collection in our phase three program. The anticipation based on previous FDA experience here is, they'll be looking for something like 52 weeks of safety data.

我們將在第三階段專案中進行長期資料收集。根據 FDA 以往的經驗，預計他們會要求提供約 52 週的安全資料。

All right, thank you.

好的，謝謝。

Thanks Kaveri.

謝謝你，卡維裡。

I'm not showing any further questions. This concludes our question-and-answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.

我不會再問其他問題了。我們的問答環節到此結束。我謹將會議交還給珍妮佛·古德，請她作閉幕致詞。

Thank you. We appreciate you joining us for today's call. I know this is the end of earnings season, so you're all probably happy as well. Enjoy the upcoming holidays, and we are available after the call or tomorrow for any follow-up questions that you may have. Thank you.

謝謝。感謝您參加今天的電話會議。我知道現在是財報季的尾聲，所以你們可能也都很高興。祝您假期愉快！如果您在通話結束後或明天還有任何後續問題，我們隨時為您解答。謝謝。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議到此結束。感謝各位參加今天的報告會。您現在可以斷開連線了。