Anavex Life Sciences Corp (AVXL) 2024 Q3 法說會逐字稿

Good morning, and welcome to the Anavex Life Sciences Fiscal 2024 Third Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. (Operator Instructions) With us today is Dr. Christopher Missling, President, and Chief Executive Officer; and Sandra Boenisch Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements.

早安，歡迎參加 Anavex 生命科學 2024 財年第三季電話會議。我叫克林特‧湯姆林森，我將擔任今天電話會議的主持人。（操作員說明）今天與我們在一起的是總裁兼執行長 Christopher Missling 博士；和桑德拉‧博尼施 (Sandra Boenisch) 財務長。在我們開始之前，請注意，在本次電話會議期間，該公司將做出一些預測和前瞻性陳述。

These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.

這些陳述只是基於當前資訊和預期的預測，涉及許多風險和不確定性。我們鼓勵您查看該公司向 SEC 提交的文件。這包括但不限於公司的表格 10-K 和 10-Q，它們確定了可能導致實際結果或事件與這些前瞻性陳述中描述的結果或事件有重大差異的具體因素。

These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital and maintenance of intellectual property rights. And with that, I'd like to turn the call over to Dr. Missling.

這些因素可能包括但不限於潛在產品的開發和/或商業化所固有的風險、臨床試驗或監管批准結果的不確定性、獲得未來資本和智慧財產權維護的需求和能力。說到這裡，我想把電話轉給米斯林醫生。

Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update. We continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by the recent presentation of comprehensive results from the Phase IIb/III plant trial, blarcamesine, ANAVEX2-73, which we presented at the Alzheimer's Association International Conference, AAIC, showing that oral once-daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease, patients with good comparative safety profile and our associated neuroimaging adverse events.

謝謝克林特，大家早安。感謝您今天與我們一起回顧我們最近報告的財務業績並提供我們的季度業務更新。我們繼續有意義地推進我們的差異化精準醫學臨床計劃，最近我們在阿茲海默症協會國際會議AAIC 上展示了IIb/III 期植物試驗blacamesine、ANAVEX2-73 的綜合結果，這凸顯了我們的優點。

Full data from the blarcamesine study in Alzheimer's disease Phase IIb/Phase III placebo-controlled clinical trial will be published in an upcoming peer-review journal.

阿茲海默症 IIb 期/III 期安慰劑對照臨床試驗的 blacamesine 研究的完整數據將在即將出版的同行評審期刊上發表。

We initiated process for submitting a marketing authorization application, MAA, to the European Medicine Agency, EMA, under the centralized procedure is underway, with full regulatory submission of blarcamesine expected in Q4 of 2024.

我們啟動了向歐洲藥品管理局 EMA 提交行銷授權申請 MAA 的流程，該集中程序正在進行中，預計將於 2024 年第四季全面提交 blacamesine 的監管申請。

The marketing authorization would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer disease. There are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030 according to the European Brain Council.

該行銷授權將允許用於治療阿茲海默症的口服布拉卡美辛直接進入整個歐盟市場。據歐洲腦理事會稱，歐洲估計有 700 萬人患有阿茲海默症，預計到 2030 年這一數字將增加一倍。

Analysis of RNA sequencing, RNA seek, which would reveal which genes are actively transcribed, or in other words, expressed in Alzheimer patients in comparison between placebo and blarcamesine of the placebo-controlled Phase IIb/III blarcamesine trial in early Alzheimer disease is underway.

對早期阿茲海默症的安慰劑對照IIb/III 期blacamesine 試驗中的RNA 定序分析（RNA search）正在進行中，該分析將揭示哪些基因在阿茲海默症患者中活躍轉錄，或換句話說，在安慰劑和blacamesine 之間進行比較。

This data might have relevant value since it may provide insight into Alzheimer's disease pathology and our cells function in the presence of placebo or in the presence of blarcamesine, respectively. Interim data is expected in the second half of 2024.

這些數據可能具有相關價值，因為它可以分別深入了解阿茲海默症的病理學以及我們的細胞在安慰劑或布拉卡美辛存在下的功能。中期數據預計將於 2024 年下半年公佈。

In June, we completed the last patient, last visit, in the ATTENTION-AD open-label extension, 96-week trial. Interim data from this trial is expected in the second half of 2024. We -- the recent AAIC 24 meeting resulted in constructive feedback, coupled with enthusiasm around our Alzheimer's disease program strengthened by the recent addition of an experienced clinical team, which support Anavex's future plans.

6 月，我們在 ATTENTION-AD 開放標籤擴展、為期 96 週的試驗中完成了最後一位患者、最後一次訪視。該試驗的中期數據預計將於 2024 年下半年公佈。我們最近舉行的 AAIC 24 會議產生了建設性的回饋，加上最近增加的經驗豐富的臨床團隊增強了人們對阿茲海默症計畫的熱情，這支團隊支持 Anavex 的未來計畫。

Educational outreach will continue as we work towards MAA submission and beyond. We are also pleased to report that the clinical team continues to beat the planned time lines in the ongoing Phase II clinical trial of ANAVEX-3-71 in schizophrenia patients.

當我們努力提交 MAA 及之後的工作時，教育推廣活動將繼續進行。我們也很高興地報告，臨床團隊在精神分裂症患者正在進行的 ANAVEX-3-71 II 期臨床試驗中繼續超越了計劃的時間線。

We have completed dosing of the first cohort and are mirroring the completion of enrollment on the second cohort of schizophrenia patients in Part A of the trial. In Parkinson's disease, initiation of ANAVEX-2-73 Phase IIb/III, a over 6-month trial, including biomarkers, which we believe may be key for understanding drug effect on Parkinson's disease pathology and account for the recently changing context in the field of Alzheimer's disease -- of Parkinson's disease is expected in the second half of 2024.

我們已經完成了第一組的給藥，並反映了試驗 A 部分中第二組精神分裂症患者的入組完成情況。在帕金森氏症方面，啟動了ANAVEX-2-73 IIb/III 期試驗，這是一項為期6 個多月的試驗，其中包括生物標記物，我們認為這可能是了解藥物對帕金森氏症病理學影響的關鍵，並解釋了該領域最近變化的背景阿茲海默症和帕金森氏症預計將在 2024 年下半年出現。

In Rett syndrome, an educational presentation was provided at the 2024 IRSF Rett syndrome Scientific Meeting going from June 18, June 19, 2024, which demonstrated the commitment of Anavex to the Rett syndrome community through direct engagement with patients and families.

在 Rett 綜合徵方面，在 2024 年 6 月 18 日至 19 日舉行的 2024 年 IRSF Rett 綜合徵科學會議上提供了教育演講，展示了 Anavex 通過與患者和家庭直接接觸對 Rett 綜合徵社區的承諾。

Positive and supportive feedback was received from families and investigators about the continued Anavex Rett syndrome program. Regarding Fragile X, new disease-specific translatable and objective biomarker data generated with ANAVEX-2-73, supporting the initiation of the ANAVEX-2-73 Phase II/III clinical trial was presented at the 19th NFXF International Fragile X conference, meeting with the NFXF leadership team strengthened Anavex's relationship with community, coupled with an increased awareness of Anavex Fragile X syndrome program by engaging with patients and families in attendance.

家屬和研究人員對繼續進行的 Anavex Rett 綜合徵計畫收到了積極和支持的回饋。關於脆性X，在第19 屆NFXF 國際脆性X 會議上提出了使用ANAVEX-2-73 產生的新疾病特異性可翻譯和客觀生物標記數據，支持啟動ANAVEX-2-73 II/III 期臨床試驗。

We are also expecting the initiation of Anavex's [three] Phase II/III preclinical trial in a new rare disease in the future. Finally, we are building medical affairs capabilities to expand education and physician support activities to ensure optimal medical impact, including continued clinical publications and evolving ANAVEX-2-73 and ANAVEX-3-71.

我們也期待未來Anavex針對一種新的罕見疾病啟動[三]II/III期臨床前試驗。最後，我們正在建立醫療事務能力，以擴大教育和醫生支援活動，以確保最佳的醫療影響，包括持續的臨床出版物和不斷發展的 ANAVEX-2-73 和 ANAVEX-3-71。

And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a financial summary of the recently reported quarter.

現在我想致電 Anavex 財務長 Sandra Boenisch，了解最近報告的季度的財務摘要。

Thank you, Christopher, and good morning to everyone. I'm pleased to share with you today our third quarter financial results for our 2024 fiscal year. Our cash position at June 30 was $138.8 million, and we have no debt. During the quarter, we utilized cash and cash equivalents of $5.2 million in operating activities after taking into account changes in noncash working capital accounts.

謝謝你，克里斯托弗，祝大家早安。我今天很高興與您分享我們 2024 財年第三季的財務表現。截至 6 月 30 日，我們的現金部位為 1.388 億美元，我們沒有債務。考慮到非現金營運資金帳戶的變化，本季我們在經營活動中使用了 520 萬美元的現金和現金等價物。

At our current cash utilization rate, we believe we have a cash runway of approximately 4 years. During our most recent quarter, general and administrative expenses were $2.9 million as compared to $2.8 million for the immediately preceding second quarter.

以我們目前的現金利用率，我們相信我們的現金跑道大約有 4 年。在最近一個季度，一般和管理費用為 290 萬美元，而上一季為 280 萬美元。

Our research and development expenses for the quarter were $11.9 million as compared to $9.7 million for the immediately preceding second quarter. And lastly, we reported a net loss of $12.2 million for the quarter, which is $0.14 per share. Thank you. And now back to you, Christopher.

我們本季的研發費用為 1,190 萬美元，而上一季的研發費用為 970 萬美元。最後，我們報告本季淨虧損 1,220 萬美元，即每股 0.14 美元。謝謝。現在回到你身上，克里斯多福。

Thank you, Sandra. In summary, we remain dedicated to developing medicines for individuals suffering from brain disorders within neurodegenerative and neurodevelopmental disorders, which could further expand our differentiated precision medicine platform to deliver scalable treatments, coupled with convenient oral dosing. I would now like to turn the call back to Clint for Q&A.

謝謝你，桑德拉。總之，我們仍然致力於為患有神經退化性和神經發育障礙的腦部疾病的個體開發藥物，這可以進一步擴展我們的差異化精準醫療平台，以提供可擴展的治療方法，並提供方便的口服劑量。我現在想將電話轉回克林特進行問答。

Thank you, Christophe. We'll now begin the Q&A session. (Operator Instructions)

謝謝你，克里斯托夫。我們現在開始問答環節。（操作員說明）

Tom Bishop, BI Research.

湯姆畢肖普 (Tom Bishop)，BI 研究人員。

Hi. You hear me now?

你好。現在你聽到我說話了嗎？

Yes. Great. Thanks, Tom.

是的。偉大的。謝謝，湯姆。

Okay. I had a couple of questions. What are your plans to meet with the FDA or regulators in Asia, which you also alluded to recently, as you did earlier with the EMA, and has the date been set for either? Or is there some sort of hold up or additional data you're waiting for?

好的。我有幾個問題。您計劃與 FDA 或亞洲監管機構會面（您最近也提到過，正如您之前與 EMA 所做的那樣），日期是否已經確定？或者您是否有某種等待或其他數據？

Thank you for the question. There's no holdup. There's only the focus right now on the EMA submission, which takes a lot of resources. We have to submit and put together a package of many modules, which is -- can be so many pages and documents.

謝謝你的提問。沒有任何阻礙。目前的重點是 EMA 提交，這需要大量資源。我們必須提交並將許多模組放在一起，這可以是很多頁面和文件。

So we focus on that. But the time will come. We don't know yet when to also meet regulatory bodies around the world, including the agency in this country as well.

所以我們專注於此。但時機終將到來。我們還不知道何時該見世界各地的監管機構，包括該國的機構。

Okay. With regards to the recent presentation at the AAIC, the Phase IIb/III data, the question comes up with regard to varying number of patients included in different measures that the company presented; and I have assumed that you -- it's just simply due to the fact that you can't force patients in the trial to come in and take certain tests, especially more invasive ones and that this explains it.

好的。關於最近在 AAIC 上發布的 IIb/III 期數據，問題在於該公司提出的不同措施中包含的患者數量不同；我假設你——這只是因為你不能強迫試驗中的患者進來接受某些測試，特別是更具侵入性的測試，這解釋了這一點。

But of course, the dark side likes to claim cherry picking. So can you discuss this aspect and put the issue to rest as to whether you do anything with the data that's given?

但當然，黑暗面喜歡宣稱摘櫻桃。那麼，您能否討論一下這個方面，並解決您是否對所提供的資料執行任何操作的問題？

May I understand better. You talk about the number of patients in each visit, schedule visits.

我可以更好地理解嗎？您談論每次就診的患者人數、安排就診時間。

In the different things like COG 13 and whatever that you presented to the AIC (technical difficulty)

在不同的事情中，例如 COG 13 以及您向 AIC 提交的任何內容（技術難度）

(technical difficulty)

（技術難度）

So the number of patients.

所以病人的數量。

(technical difficulty) time point?

（技術難度）時間點？

Yes.

是的。

So the -- so this is -- there is no other way to explain it that every patient does not always present at the time point in question. He can skip. He can be impaired because of COVID and this trial was during COVID. It's very normal.

因此，沒有其他方法可以解釋每個患者並不總是在相關時間點出現。他可以跳過。他可能會因新冠肺炎而受到損害，而這次試驗是在新冠肺炎期間進行的。這很正常。

You just have to then always account for when you have a data point, and that's exactly described in the presentation. And when you look at other papers from [Aduam], from lecanemab, donanemab, they are exactly the same.

然後，您只需要始終考慮何時擁有數據點，這在簡報中進行了準確描述。當你查看 [Aduam]、lecanemab、donanemab 的其他論文時，它們是完全相同的。

Every number is different at every time point because they are not always the same amount of patients attending the visit. So that's a very (technical difficulty) procedure.

每個時間點的每個數字都不同，因為參加就診的患者數量並不總是相同。所以這是一個非常（技術難度）的過程。

But you used the data exactly as given to you by the biostatistical firm? And who was that?

但是您使用的數據與生物統計公司提供的數據完全一樣嗎？那是誰？

Yes. Of course, there is no other way than to take every available data point. There is no other way to do that other than that.

是的。當然，除了獲取每個可用的數據點之外，沒有其他方法。除此之外沒有其他辦法可以做到這一點。

Okay. And I wanted to clear up or confirm for myself the so-called the $150 million stock offering that the various news headline. That was just a shelf offering to be used as needed opportunistically in the future, correct?

好的。我想親自澄清或證實各種新聞標題中所謂的 1.5 億美元股票發行。這只是一個貨架產品，供將來根據需要機會使用，對嗎？

So the company has been extremely cautious with financing. We've been very conservative while other companies spend a ton of money. We've been very diligent on being very cautious with our fiscal responsible behavior.

因此，公司對於融資一直極為謹慎。當其他公司花費大量資金時，我們一直非常保守。我們一直非常努力地對我們的財政負責任的行為保持非常謹慎的態度。

So what we did was just to make sure that one day in the future, when we do need more resources for market entry or other reasons, that we have that in place. So it's not meant to be used today or tomorrow, but the opportunity will -- could arise, but it was just to put in place something so we have it in place for the future.

所以我們所做的只是確保將來有一天，當我們確實需要更多資源進入市場或其他原因時，我們已經準備好了。因此，它並不意味著今天或明天就可以使用，但機會可能會出現，但這只是為了將某些東西落實到位，以便我們為未來做好準備。

Okay. And regarding Rett, is there a date to initiate another Rett trial or -- I'm not sure what's going on there.

好的。關於雷特，是否有啟動另一次雷特試驗的日期，或者——我不確定那裡發生了什麼。

So we have had very good feedback from the conference that we mentioned, and there's no date yet, but we proceed, as we stated, to do a larger study for Rett syndrome as well.

因此，我們從我們提到的會議中得到了非常好的回饋，而且還沒有確定日期，但正如我們所說，我們也將繼續對雷特氏症進行更大規模的研究。

Okay. And finally, with regards to Fragile X was there a Phase I? You mentioned going to a Phase IIb/III, I think, and.

好的。最後，關於 Fragile X 是否有第一階段？我想，你提到要進入 IIb/III 期。

Phase I was done with blarcamesine with ANAVEX-2-73 already. So we can start into a Phase II because of the Phase I was already done prior to this because of the drugs already tested in human -- healthy volunteers.

第一階段已經用 blacamesine 和 ANAVEX-2-73 完成。因此，我們可以開始進入第二階段，因為第一階段已經在此之前完成，因為藥物已經在人體健康志願者中進行了測試。

Okay. And actually, I have one more. With regard to schizophrenia, can you remind us a little more or explain the first cohort, the second cohort, Part A.

好的。事實上，我還有一個。關於精神分裂症，您能否再提醒我們一點，或解釋第一組、第二組、A 部分。

Yes.

是的。

Is there a Part B? I mean, could you just run through that again?

有B部分嗎？我的意思是，你能再說一次嗎？

Sure. So Part A is single ascending doses. So we test the tolerability of the patients for the first doses, a lower dose, and a higher dose subsequently. And the second higher doses now almost completed enrollment. And the Part B will be a longitudinal study around about, I think, it's 28 days or so.

當然。所以 A 部分是單次遞增劑量。因此，我們測試了患者對首次劑量、較低劑量和隨後較高劑量的耐受性。第二個更高劑量現在幾乎完成了註冊。B 部分將是一項縱向研究，我認為大約需要 28 天左右。

So the drug will be given at the dose -- which will be considered the best tolerated dose. And we will then observe patients over a longer period of time.

因此，藥物將以被認為是最佳耐受劑量的劑量給藥。然後我們將對患者進行更長時間的觀察。

So the second dose is the higher dose.

所以第二次劑量是更高的劑量。

So, the second dose from Part A is the higher dose and Part B will be the dose which we choose once it starts, and it will be a longer trial of 28 days or 4 weeks basically.

所以，A部分的第二劑是較高的劑量，B部分將是我們開始時選擇的劑量，基本上將是28天或4週的較長試驗。

Soumit Roy, Jones Research.

蘇米特·羅伊，瓊斯研究中心。

Good morning, everyone, and also congrats on executing on multiple fronts. On the AIC data, Alzheimer's disease, could you give us a little color, make us understand on the dose dependency or a clear lack of dose dependency between 30 milligrams, 50 milligrams, there was ADAS COG was working a little better for the 50-milligram versus CDRs before the 30 milligram.

大家早安，也恭喜您在多個方面的執行。關於AIC 數據，阿茲海默症，您能否給我們一些說明，讓我們了解劑量依賴性或30 毫克和50 毫克之間明顯缺乏劑量依賴性，ADAS COG 在50 毫克的情況下工作得更好一些毫克與 30 毫克之前的 CDR。

And the discontinuation rate, are you -- so what percent of the 50 milligram did you see had to scale back to 30 milligram because of adverse events in the open-label extension?

停藥率是——那麼，由於開放標籤擴展中的不良事件，您看到的 50 毫克劑量中有多少必須縮減至 30 毫克？

So let me talk -- address the first question first. So the 2 arms are those groups. And we use also the expression for that reason, when you read our description and the presentation, we talk about the dose groups, 30-milligram dose group or 50-milligram group.

那我來談談──先解決第一個問題。所以這兩隻手臂就是那些組。基於這個原因，我們也使用這個表達方式，當您閱讀我們的描述和演示時，我們談論劑量組，30 毫克劑量組或 50 毫克劑量組。

So since we allow titration to the best tolerated dose for those 2 arms as well as Placebo, by the way. We basically realize that the -- at the end of the day, the target dose for most patients was relatively close to each other in those 2 arms.

因此，順便說一下，我們允許將這 2 組以及安慰劑滴定至最佳耐受劑量。我們基本上意識到，最終，大多數患者的目標劑量在這兩個臂中相對接近。

So while in the 50-milligram group, they were some with 50 milligrams, there were also some with 30. So it was a bit higher than the 30-milligram group, but not by much. So they are pretty much close. And that's why we also prespecified the 2 arms together against placebo in a predefined analysis. So that was the background. So we have seen prior to that a dose response curve in our Phase IIa.

所以在50毫克組中，有的人是50毫克，也有的人是30毫克。所以它比 30 毫克組高一點，但不是很多。所以他們非常接近。這就是為什麼我們還在預先定義的分析中預先指定了 2 組一起對抗安慰劑。這就是背景。所以我們之前已經看到了 IIa 期的劑量反應曲線。

So there's no doubt about the dose response is confirmed. But what we now notice is that in this trial where we -- and that's coming to the second part of the question, where we noticed where we force patients to uptake trade to the (technical difficulty) dose 50 very quickly within 2 weeks and then to 3 weeks, we noticed that didn't -- was very well received.

所以毫無疑問劑量反應就被證實了。但我們現在註意到的是，在這個試驗中，我們——這就是問題的第二部分，我們注意到我們強迫患者在兩週內非常快地接受（技術難度）劑量 50，然後到了三週，我們發現並沒有──很受歡迎。

Some patients had some dizziness. And then we didn't feel comfortable about it, so because they are not impaired patients, they're early Alzheimer. They felt saying, maybe we have COVID. I don't want to continue this. It was during the time of COVID, of course, as well. So that's why we had some dropouts at the higher dose more than in the lower dose group.

部分患者有一定的頭暈症狀。然後我們對此感到不舒服，因為他們不是受損患者，所以他們是早期阿茲海默症。他們覺得，也許我們感染了新冠病毒。我不想再繼續這樣下去了。當然，那也是在新冠疫情期間。這就是為什麼我們在高劑量組的退出率高於低劑量組的退出率。

So what we now realize when we did the open-label study where we allowed a more, I would say, lenient and less stringent way of up titration and also allowing patients to take the drug at night time instead of in the morning, which we basically force patients to take during the trial early in the morning.

所以我們現在意識到，當我們進行開放標籤研究時，我們允許一種更寬鬆、更寬鬆的滴定方式，並且允許患者在晚上而不是早上服用藥物，我們試驗期間基本上強迫患者在清晨服用。

So we noticed that there was much higher tolerance for either dose, 30 or 50 as long as they were allowed to get used the drug for a longer period of time. And we noticed it also in the compassionate use program where this extremely high tolerance with allowing patients to titrate to 50 or 30 as long as they have enough time to do that and then taking also nighttime dosing.

因此我們注意到，只要允許他們更長時間地使用該藥物，對 30 或 50 劑量的耐受性要高得多。我們在同情使用計劃中也注意到了這一點，其中這種極高的耐受性允許患者滴定至 50 或 30，只要他們有足夠的時間這樣做，然後也服用夜間劑量。

So we don't see the adverse events we have seen in this trial because we basically force them to titrate so quickly up to the target dose. And we also have to point out that it's actually a -- clearly a manifestation of a manageable and addressable adverse event. It's not like when you look at brain bleeding or brain swelling from the antibodies, which we don't have, that no matter how you take the drug, you always will have 30 or more percentage of patients with that very dangerous side effects of a drug of an antibody, which we don't have.

因此，我們沒有看到在這次試驗中看到的不良事件，因為我們基本上迫使他們如此快速地滴定至目標劑量。我們還必須指出，這實際上顯然是可管理和可解決的不良事件的表現。這並不像當你觀察由抗體引起的腦出血或腦腫脹時（我們沒有抗體）一樣，無論你如何服用藥物，總會有 30 或更多的患者出現非常危險的副作用。 。

But in our case, the adverse event of dizziness is a manageable one because it's just dependent on the titration schedule, and that can be fixable, changed, and that's why we now will, of course, do in the future. So that's the answer to your question.

但就我們而言，頭暈的不良事件是可以控制的，因為它只取決於滴定時間表，並且可以修復、改變，這就是為什麼我們現在當然會在未來這樣做。這就是你問題的答案。

And also, needless to say that we are also knowledge that -- and we've heard that from physicians that the disease, again, not all patients had that. We also have to put this in perspective that it's a sign that shows penetration in the brain and shows that something is happening in the brain.

而且，不用說，我們也知道——而且我們從醫生那裡聽說，這種疾病並不是所有患者都患有這種疾病。我們還必須正確地看待這一點，這是一個表明大腦已被滲透並表明大腦中正在發生某些事情的跡象。

And also one last point I'd like to make that dizziness lasted really relatively short for those patients who had it, was sometimes between 7 to 11 days in the average. So it's a very -- and a mild form of dizziness. So it's a very easy to address situation.

最後一點，我想指出的是，對於那些患有頭暈的患者來說，頭暈持續的時間確實相對較短，有時平均為 7 至 11 天。所以這是一種非常輕微的頭暈。所以這是一個很容易解決的情況。

But it shows up in this trial because, again, we forced patients to go to these high doses very quickly, and we learned a lesson that we can avoid that.

但它在這次試驗中出現了，因為我們再次強迫患者很快接受這些高劑量，我們吸取了教訓，我們可以避免這種情況。

That is really helpful to color. So last question is, when should we expect the open-label 96-week data. Is it CTAD or more towards the end of the year? And should we expect after that data you would approach the FDA with the entire package submitted to European authority plus this open label? Or if you can provide any details there?

這對於上色確實很有幫助。所以最後一個問題是，我們什麼時候應該期待開放標籤的 96 週資料。是 CTAD 還是接近年底？我們是否應該期望在獲得這些數據後，您會向 FDA 提交整個包裝以及這個開放標籤？或者您可以在那裡提供任何詳細資訊嗎？

Yes. So let us first put together, our data together. But once we have it, we will make the decision. But all your suggestion could be a valid recommendations.

是的。因此，讓我們先將數據放在一起。但一旦我們有了決定，我們就會做出決定。但您的所有建議都可能是有效的建議。

Thank you, and congratulations again on the progress.

謝謝，並再次恭喜取得的進展。

Thank you. Appreciate it.

謝謝。欣賞它。

That's all the questions for now. Dr. Missling.

這就是目前所有的問題。米斯林博士。

Thank you. So in closing, we continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives, living with these devastating conditions. Thank you very much.

謝謝。因此，最後，我們將繼續專注於執行和商業準備，推進我們的治療管道，以潛在地改善患有這些毀滅性疾病的患者的生活。非常感謝。

Thank you, ladies, and gentlemen. This concludes today's conference call. We appreciate your participation, and you can now disconnect.

謝謝你們，女士們、先生們。今天的電話會議到此結束。我們感謝您的參與，您現在可以斷開連接。