Compass Pathways PLC (CMPS) 2024 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the Compass Pathfinders Limited 4th quarter 2024 investor call. (Operator Instructions).I will now hand today's call over to Stephen Schultz, Senior Vice President of Investor Relations. Please go ahead, sir.

女士們，先生們，感謝你們的支持，歡迎參加 Compass Pathfinders Limited 2024 年第四季投資者電話會議。 （操作員指示）。我現在將今天的電話交給投資者關係高級副總裁史蒂芬舒爾茨。先生，請繼續。

Welcome all of you and thank you for joining us today for our fourth quarter 2024 results conference call. Again, my name is Step Schultz, Senior Vice President of Investor Relations at Compass Pathways. Today I'm joined by Kabir Nath, our Chief Executive Officer, and Teri Loxam, our Chief Financial Officer, who will have prepared remarks. In addition, Dr. Guy Goodwin, our Chief Medical Officer, Lori Englebert, our Chief Commercial Officer, and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A.

歡迎大家，感謝您今天參加我們的 2024 年第四季業績電話會議。再次聲明，我叫 Step Schultz，是 Compass Pathways 投資人關係資深副總裁。今天，我們的執行長 Kabir Nath 和財務長 Teri Loxam 也和我一起出席了會議，他們將發表準備好的演講。此外，我們的首席醫療官 Guy Goodwin 博士、首席商務官 Lori Englebert 和首席病患長 Steve Levine 博士也將出席問答環節。

The call is being recorded and will be available on the Compass Pathways investor relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended.

這次電話會議將被錄音，並將在會議結束後不久在 Compass Pathways 投資者關係網站上提供，保留期為 30 天。在我們開始之前，請允許我提醒大家，在今天的電話會議中，團隊將根據經修訂的 1995 年《私人證券訴訟改革法案》做出前瞻性陳述。

You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those risks and uncertainties described under the heading risk factors. In our most recent annual report on Form 10-K filed with the US Securities and Exchange Commission and in subsequent filings made by Compass with the SEC.

您不應過度依賴這些前瞻性陳述。由於各種風險、不確定性和其他因素（包括「風險因素」標題下所述的風險和不確定性），實際事件或結果可能與任何前瞻性陳述所表達或暗示的事件或結果有重大差異。在我們最近向美國證券交易委員會提交的 10-K 表格年度報告中以及 Compass 隨後向美國證券交易委員會提交的文件中。

Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement even if our estimates or assumptions change. I'll now hand the call over to Kabir Nath.

此外，這些前瞻性陳述僅代表我們截至今天的觀點，不應被視為代表我們在任何後續日期的觀點。即使我們的估計或假設發生變化，我們明確否認更新或修改任何前瞻性聲明的義務。我現在將電話交給卡比爾·納特。

Thank you, Step. Good day, everyone, and thank you for joining us. Let me begin by thanking our existing and new investors who participated in our financing last month. This not only positions us to complete the COMP360 program in TRD, but also importantly allows us to progress a PTSD development program beyond the encouraging results from our open label phase 2A study that we received last May.

謝謝你，Step。大家好，感謝大家的參與。首先，我要感謝上個月參與我們融資的現有投資者和新投資者。這不僅使我們能夠完成 TRD 中的 COMP360 計劃，更重要的是，使我們能夠推進 PTSD 開發計劃，超越我們去年 5 月收到的開放標籤 2A 期研究的令人鼓舞的結果。

This will be an exciting couple of years for Compass with multiple upcoming data readouts and the January financing positions us well for success. As we guided to on the third quarter earnings call, we eagerly await the top line results from the six-week primary endpoint from the 005 trial in the second quarter of this year.

對於 Compass 來說，接下來的幾年將是令人興奮的，即將發布的多個數據讀數以及一月份的融資為我們成功奠定了良好的基礎。正如我們在第三季財報電話會議上所指出的，我們熱切期待今年第二季 005 試驗六週主要終點的頂線結果。

We've recruited over 90% of patients in the trial, so we're within sight of the end of recruitment, which we will announce once enrollment is complete. As a reminder, when the top line results become available in the second quarter, we'll be disclosing three key efficacy measures for the six-week primary endpoint.

我們已經招募了超過 90% 的試驗患者，因此招募工作即將結束，我們將在招募完成後宣布這項消息。提醒一下，當第二季公佈頂線結果時，我們將揭露六週主要終點的三個關鍵療效指標。

The madras affect difference between the arms, the associated P value, and confidence intervals. We believe that these data should provide investors with a clear understanding of the treatment effect and if positive, together with our phase 2b results, provide a strong validation for the treatment potential for COMP 360 in TRD.

馬德拉斯影響組間差異、相關 P 值和信賴區間。我們相信這些數據應該能讓投資者清楚地了解治療效果，如果結果呈陽性，再加上我們的 2b 期結果，將為 COMP 360 在 TRD 中的治療潛力提供強有力的驗證。

From a safety standpoint, given that the trial is continuing blinded through 26 weeks, we'll provide a high-level assessment from the independent DSMB which reviews unblinded safety data on a regular basis. For the 006 trial, which is the second phase 3 trial, enrollment is going well, and the high throughput 005 sites will convert over to 006 sites upon completing enrollment in 005.

從安全角度來看，鑑於試驗將持續 26 週的盲法，我們將提供獨立 DSMB 的高級評估，該評估會定期審查未盲法的安全數據。對於 006 試驗（即第二階段 3 期試驗），招募工作進展順利，高吞吐量 005 站點將在 005 完成招募後轉換為 006 站點。

So we're gaining momentum and we're excited for the 26-week results of six to read out in the second half of 2026. As mentioned earlier, given the recent financing, we're now able to resume the development of COMP360 for PTSD, and we're in the process of refining our plans for a late-stage clinical program.

因此，我們正在不斷取得進展，並期待 2026 年下半年公佈的 26 週六項研究結果。如前所述，鑑於最近的融資，我們現在能夠恢復針對 PTSD 的 COMP360 的開發，並且我們正在完善後期臨床項目的計劃。

We're working through the various questions to address as well as potential clinical designs, the scope of which is under discussion both internally and with external advisors. Our primary goals are to maximize the probability of success and to get CO 360 to those who suffer from PTSD as quickly as possible. We look forward to updating you on our plans as they progress.

我們正在研究解決的各種問題以及潛在的臨床設計，其範圍正在內部和與外部顧問討論中。我們的主要目標是最大限度地提高成功的可能性，並儘快讓 CO 360 幫助那些患有 PTSD 的人。我們期待向您通報我們計劃的進展。

Finally, on the commercial front, our strategic collaborations with select healthcare delivery organizations, including interventional psychiatry networks are providing important insights into the various care settings, insights which we're using to inform our strategy for launch and post launch scaling.

最後，在商業方面，我們與精選醫療保健提供組織（包括介入精神病學網絡）的策略合作為各種護理環境提供了重要見解，我們正在利用這些見解來指導我們的發布和發布後擴展戰略。

Many of these organizations are delivering bravado now, which is particularly helpful as we identify COMP360 opportunities to scale within their operating models. While our phase three data will give us full clarity on the COMP360 profile, based on our data to date, we believe we will have a clinically differentiated treatment that is rapid acting with meaningful durability. Let me now hand the call over to Teri for the financial update.

許多這樣的組織現在都表現出了勇氣，這對於我們發現 COMP360 在其營運模式中擴展的機會特別有幫助。雖然我們的第三階段數據將使我們全面了解 COMP360 概況，但根據我們迄今為止的數據，我們相信我們將擁有一種快速起效且具有顯著持久性的臨床差異化治療方法。現在，讓我將電話交給 Teri，請他報告財務最新情況。

Thank you, Kabir. I'll now step through the full year financial results. Cash used in operations for the full year was $119.2 million within the guidance range that we provided last year of $114 million to $120 million. For the year ended December 31, 2024. Net loss was $155.1 million or $2.30 per share compared with a net loss of $118.5 million or $2.32 per share during the same period in 2023.

謝謝你，卡比爾。我現在將逐步介紹全年財務表現。全年營運現金流為 1.192 億美元，處於我們去年提供的 1.14 億美元至 1.2 億美元的指導範圍內。截至 2024 年 12 月 31 日止年度。淨虧損為 1.551 億美元，即每股 2.30 美元，而 2023 年同期的淨虧損為 1.185 億美元，即每股 2.32 美元。

These results include non-cash share-based compensation of $19.5 million in 2024 and $17.3 million in 2023. R&D expenses were $119 million in 2024 compared with $87.5 million in the prior year. G&A expenses were $59.2 million in 2024 compared with $49.4 million in the prior year. Debt under the Hercules loan facility was $30.2 million at the end of the fourth quarter.

這些結果包括 2024 年 1,950 萬美元和 2023 年 1,730 萬美元的非現金股權薪酬。2024 年研發費用為 1.19 億美元，而前一年為 8,750 萬美元。2024 年的一般及行政費用為 5,920 萬美元，而前一年為 4,940 萬美元。第四季末，Hercules 貸款債務為 3,020 萬美元。

At December 31, 2024, we had cash and cash equivalents of $165.1 million. As Kabir mentioned in January of this year, we completed a financing which resulted in net proceeds of approximately $140 million which, together with the $165 million of cash that we had at the end of the year, provides us runway to fund our operations at least through the planned 26-week data readout from our COMP006 study, which is expected in the second half of 2026.

截至 2024 年 12 月 31 日，我們的現金和現金等價物為 1.651 億美元。正如 Kabir 在今年 1 月提到的那樣，我們完成了一項融資，淨收益約為 1.4 億美元，加上我們在年底擁有的 1.65 億美元現金，為我們提供了資金支持，至少可以通過我們計劃的 COMP006 研究的 26 週數據讀數來維持我們的運營，該研究預計將於 2026 年下半年完成。

Regarding 2025 financial guidance, we expect net cash used in operations for the full year of 2025 to be within the range of $120 million to $145 million. Thank you, and I'll now turn the call back over to Kabir.

關於 2025 年財務指導，我們預計 2025 年全年營運所用淨現金將在 1.2 億美元至 1.45 億美元之間。謝謝，現在我將把電話轉回給卡比爾。

Thank you, Teri. We have an exciting couple of years ahead with multiple data readouts from our pivotal phase three program. For 005, we expect to report the top line six-week primary endpoint data towards the end of next quarter. And then the 26-week data once 006 participants have completed Part A of that trial. For that 006 trial, we expect to disclose the 26-week results in the second half of 2026.

謝謝你，泰瑞。我們從關鍵的第三階段計劃中獲得多個數據讀數，未來幾年我們將迎來令人興奮的時光。對於 005，我們預計將在下個季度末報告頂線六週主要終點數據。然後，當 006 名參與者完成該試驗的 A 部分時，就會獲得 26 週的數據。對於 006 試驗，我們預計將在 2026 年下半年揭露 26 週的結果。

In parallel, we're continuing to prepare for the launch of this potentially paradigm changing treatment. Given the higher need and limited current treatment options, we see significant commercial opportunities in TRD and PTSD. As mentioned at the beginning of the call, Dr. Guy Goodwin, Lori Englebert, and Dr. Steve Levine will also be available for Q&A.

同時，我們正在繼續為推出這種可能改變範式的治療方法做準備。鑑於更高的需求和有限的當前治療選擇，我們看到 TRD 和 PTSD 中存在巨大的商業機會。正如電話會議開始時所提到的，Guy Goodwin 博士、Lori Englebert 和 Steve Levine 博士也將參加問答環節。

Thank you. And I will now turn the call back to the operator for Q&A.

謝謝。現在我將把電話轉回給接線員進行問答。

(Operator Instructions). Your first question is from the mind of Gavin Clark-Gartner with Evercore ISI.

（操作員指令）。您的第一個問題來自 Evercore ISI 的 Gavin Clark-Gartner。

Hey guys, thanks for taking the question. So I believe the six-week, Madras delta and the phase 2B was a bit above, 5 points. You think that should be a reasonable bar for the 005 initial top line?

嘿夥計們，謝謝你們回答這個問題。因此我相信為期六週的馬德拉斯三角洲和 2B 階段會略高於 5 分。您認為這應該是 005 初始頂線的合理標準嗎？

Hi Gavin, it's Kabir, and just to check, you can hear us clearly.

你好，加文，我是卡比爾，我來確認一下，你能清楚地聽到我們說話嗎？

Yes.

是的。

Great, thank you. Yeah, so as we've, I think, consistently said, we have used the phase 2B, and that's six-week data from the Phase 2B as the benchmark for, how we plan the paring for the phase three studies. So I think what you said is reasonable again, a reminder that clinically meaningful is a significantly lower number in terms of effect size, but yeah, that that is the guide that we have used in planning the phase three.

太好了，謝謝。是的，正如我們一直說的那樣，我們已經使用了 2B 階段，也就是 2B 階段的六週數據作為基準，用於規劃第三階段研究的配對。所以我認為你所說的再次是合理的，提醒我們，就效果大小而言，臨床意義是一個明顯較低的數字，但是，是的，這是我們在規劃第三階段時所使用的指南。

Okay great and just on the PTSD side maybe you could just frame for the upcoming advisory committee meeting if there's anything you're looking to learn that'll inform your development. Thank you.

好的，太好了，就創傷後壓力症候群 (PTSD) 方面而言，如果您想了解任何有助於您發展的信息，也許您可以為即將召開的諮詢委員會會議做個安排。謝謝。

Thanks. So the upcoming Brex Acom meeting, you mean, yes?

謝謝。那麼，您是說即將舉行的 Brex Acom 會議嗎？

Yes, correct.

是的，正確。

Yes, Guy.

是的，蓋伊。

Well, we'll be interested in basically how they view the patient population. That's something that requires a certain amount of thought with PTSD because of the spread of different kinds of trauma that result in PTSD and also the complexity of some of the lives, the early lives of patients who developed PTSD. So I think that's one of the key things.

嗯，我們主要感興趣的是他們如何看待患者群體。對於 PTSD，需要進行一定程度的思考，因為導致 PTSD 的各種創傷的蔓延，以及某些 PTSD 患者的生活（早期生活）的複雜性。所以我認為這是關鍵因素之一。

Obviously, we will be interested in how they view the issue of the actual difference in the scores, the caps 5, which is still a relatively new endpoint for use both clinically and in research and indeed in regulatory trials. So how they interpret changes in that in terms of remission response, I think that will be informative for us and will guide us in how we think about our studies.

顯然，我們會對他們如何看待分數的實際差異問題感興趣，即上限 5，這在臨床、研究以及監管試驗中使用仍然是一個相對較新的終點。因此，他們如何解釋緩解反應方面的變化，我認為這將為我們提供信息，並將指導我們如何思考我們的研究。

I don't think beyond that, given the fact that the placebo arm here will be daily placebo, it doesn't really offer us a great deal of guidance as to what our placebo response might look like. So there are limitations, but we'll of course we'll be tuning in.

我不認為除此之外，考慮到這裡的安慰劑組將是每日安慰劑，它實際上並沒有為我們提供大量有關安慰劑反應可能會是什麼樣子的指導。因此有局限性，但我們當然會進行調整。

Great thank you.

非常感謝。

Thanks, Gavin.

謝謝，加文。

Your next question is from the line of Paul [Maddie's] with Staples.

您的下一個問題來自史泰博的 Paul [Maddie]。

Hey there, this is Julian on for Paul. Thanks a lot for taking our question. I guess can you just talk a little bit about what's actually going to be disclosed in the top line for the upcoming COMP005 readout? I know you talked about some high-level safety as well as potential commentary from a DSMB on suicidal ideation. So just any commentary on that would be helpful and then also just any colour on enrollment.

大家好，我是 Julian，代替 Paul。非常感謝您回答我們的問題。我想您能否稍微談談即將發布的 COMP005 讀數的第一行實際上會披露什麼內容？我知道您談到了一些高級別的安全問題以及 DSMB 對自殺意念的潛在評論。因此，任何關於這一點的評論都會有所幫助，任何關於招生的評論也會有所幫助。

Are these studies still enrolling and are you on track? Thank you.

這些研究是否仍在招生？進展如何？謝謝。

No thanks. Happy to take both of those. So yeah, in terms of what we will be disclosing, as we've said consistently from an efficacy perspective with the six-week data, it is going to be the madras effect size, the difference between the arms, the P value, and confidence interval that's associated with that effect size difference.

不，謝謝。很高興能接受這兩個。是的，就我們將要揭露的內容而言，正如我們從六週數據的功效角度一貫所說的那樣，它將是馬德拉斯效應大小、組間差異、P 值以及與該效應大小差異相關的置信區間。

From a safety perspective, as you've said, it will be a statement from the DSMB, including specifically as to whether they see anything clinically concerning in terms of imbalance on suicidal ideation. And just a reminder, the DSMB is seeing unblinded safety data on a regular basis, most recently this month, in fact, and have just preceded us to direct without change, without amendment.

從安全角度來看，正如您所說，這將是來自 DSMB 的聲明，具體包括他們是否在自殺意念失衡方面發現任何臨床上令人擔憂的問題。需要提醒的是，DSMB 會定期查看未盲安全數據，事實上最近一次是在這個月，並且已經先於我們發出了未經修改和修訂的指令。

And in terms of recruitment, as I said on the call for 005, we are now over 90% recruited for that trial, so we're very much within sight at the end of that 006 is continuing to recruit well. One of the factors there is, as we've said, high performing 005 sites will roll over into 006, and that's a process that again we now can start planning with exquisite detail. And so we continue to be on track now for 26 week data for 006 in the second half of 2026.

在招募方面，正如我在 005 號電話會議上所說的那樣，我們現在已經招募了超過 90% 的人參加該試驗，因此我們完全可以預見 006 號試驗結束時招募工作將繼續順利進行。其中一個因素是，正如我們所說，高效能的 005 網站將延續到 006，而這是我們現在可以開始精心規劃的過程。因此，我們現在將繼續追蹤 2026 年下半年 006 的 26 週數據。

Your next question comes from the line of Charles Duncan with Cantor. Charles, your line is open. There's no response from Mr. Duncan's line. We'll go to the next question. Your next question is from the line Ritu Baral with TD Cowen.

您的下一個問題來自 Cantor 的 Charles Duncan。查爾斯，你的線路已開通。鄧肯先生的電話沒有回應。我們來討論下一個問題。您的下一個問題來自 TD Cowen 的 Ritu Baral。

Hi guys, thanks for taking the question. Kabir, what else will we get with top line as far as additional analysis? Will we still get remissions, responses, and how will that play? How do you think the relative importance will play both to regulators and clinicians in relation to sort of the top line madras means, and will we be getting any secondary scales as well?

大家好，感謝你們回答這個問題。卡比爾，就附加分析而言，我們還能得到什麼呢？我們還會得到緩解和回應嗎？這將會產生什麼結果？您認為，相對於頂級馬德拉斯方法，其相對重要性對於監管機構和臨床醫生有何影響？我們是否也會得到任何次要的量表？

Thanks, Ritu. So no, to be clear with the six-week data, we are not going to be getting any secondaries. We're not actually going to be getting remission response, or anything else. It is literally just going to be the effect size difference on Madras with the six-week data.

謝謝，Ritu。因此，為了明確六週的數據，我們不會獲得任何二次數據。我們實際上不會得到緩解反應或其他任何東西。這其實只是六週數據對馬德拉斯的影響大小差異。

Got it. And then as you are at 90% enrolled, how has the patient disposition and demographic shaped up to your expectations? Can you talk about what percentage has finally come in on background SSRIs and how that may or may not impact the final efficacy and tolerability data that comes out.

知道了。那麼，當您的入院率達到 90% 時，病患的傾向和人口結構是否符合您的預期？您能否談談最終採用背景 SSRI 治療的比例是多少，以及這是否會對最終得出的療效和耐受性數據產生影響。

Thanks. We are, we aren't seeing that broken down in detail as it goes. My impression is just from the numbers of patients in washout that we're seeing a similar kind of number to what we saw in the phase two, but I can't give you the precise statistic on that.

謝謝。我們還沒有看到事情進展的詳細分解。我的印像是，從洗脫期患者的數量來看，我們看到的數字與第二階段看到的數字相似，但我無法給你精確的統計數據。

In other respects, we aren't looking again as we go at details of the, for example, comorbidities, the drugs actually use, the numbers of exposures, we're just not looking at that as we go. That's not been part of our protocol.

在其他方面，我們不會再查看細節，例如合併症、實際使用的藥物、暴露次數，我們只是沒有在進行過程中查看這些。這不屬於我們的協議的一部分。

Got it. And will you release with topline what the powering of the study was designed to be?

知道了。您能否在 Topline 上發布這項研究的設計目標是什麼？

Yes, I guess if you're interested, we'd be happy to share that. Once we have the data, yeah.

是的，我想如果您有興趣，我們很樂意分享。一旦我們有了數據，是的。

One, okay. Thank you. Thanks for taking the questions.

一，好的。謝謝。感謝您回答這些問題。

Thanks Ritu

謝謝 Ritu

Your next question is from a line of Charles Duncan with Cantor.

您的下一個問題來自 Cantor 的 Charles Duncan。

I, hopefully you can hear me be team. Thanks for taking the question. Congrats on the progress. Appreciate the added colour. Wanted to follow up on a previous question with regards to top line for 005. And the recent DSMB meeting, I guess I'm wondering if you could provide a little bit of colour on what you would anticipate in terms of suicidal ideation.

我，希望你們能聽到我的團隊聲音。感謝您回答這個問題。恭喜你取得進展。欣賞添加的色彩。想要跟進 005 頂線的先前問題。關於最近的 DSMB 會議，我想知道您是否可以稍微解釋一下您對自殺意念的預期。

We've talked about that in the past. I know it happens in this patient population but Provide a little more information on what you would have expected out of this patient population.

我們過去曾討論過這個問題。我知道這種情況發生在該患者群體中，但請提供更多有關您對該患者群體的預期的資訊。

Hi Charles, Guy here. I mean we do expect to see suicidal ideation and as we're collecting it on a systematic basis using the Columbia rating scale. In due course, we'll be able to summarize for the whole population the extent to which we saw suicidality using that scale. Obviously, the serious adverse events that we collect have to be contextualized, and that is what the DSMB is able to do because it's unblinded.

你好，查爾斯，我是蓋伊。我的意思是，我們確實希望看到自殺意念，並且我們正在使用哥倫比亞評分量表系統地收集這些資訊。在適當的時候，我們將能夠使用該量表總結整個人口的自殺程度。顯然，我們收集的嚴重不良事件必須結合具體情況，而這正是 DSMB 能夠做到的，因為它是非盲的。

We can't do that from our own perspective, so we rely on their clinical judgment to decide that there is no clear reason to think that what is happening in the trial represents a signal of danger. So that essentially, we rely on their clinical judgment to look at all of the information. And we have to trust what they feed back to us.

我們不能從自己的角度來做到這一點，所以我們依靠他們的臨床判斷來決定沒有明確的理由認為試驗中發生的事情代表著危險的信號。因此，從本質上講，我們依靠他們的臨床判斷來查看所有資訊。我們必須相信他們給我們的回饋。

And Guy It's probably worth you adding that the reason we might see suicidal ideation is because of the patient population, so you may want to expand on that, and it's not necessarily part of our job.

蓋伊，也許值得你補充的是，我們之所以會看到自殺意念，是因為患者群體，所以你可能想詳細說明一下，但這不一定是我們工作的一部分。

Yeah, no, I mean, I was sort of taking that as read, but perhaps that needs to be restated that depression is inherently carries with it suicidality, and suicidality. Carries with it the risk of attempted or completed suicide. So any study that enrolls a large number of patients with treatment resistant depression in particular is running that risk.

是的，不，我的意思是，我有點把它當作讀物，但也許需要重申的是，憂鬱症本質上是伴隨自殺傾向和自殺傾向的。有自殺未遂或自殺成功的危險。因此，任何招募大量難治性憂鬱症患者的研究都存在這種風險。

Obviously we are trying to ensure that that risk is minimal for the individuals who enter the study, but there is no doubt that the condition carries the risk.

顯然，我們正在努力確保參與研究的個人的風險最小化，但毫無疑問，這種情況是有風險的。

That, yeah, that makes sense. I get that. But with regard to the DSMB review, they have been looking at if there are any events and tracking that and you would know that if there were correct.

是的，這很有道理。我明白。但就 DSMB 審查而言，他們一直在查看是否有任何事件並進行跟踪，如果正確的話你就會知道。

We would know if they were concerned about the events that have occurred and that they have full information about, yeah.

我們會知道他們是否關心已經發生的事件，並且他們是否掌握了全部信息，是的。

Okay, very good. Thanks for taking the question.

好的，非常好。感謝您回答這個問題。

Your next question is from the line of Leonid Timashev with RBC.

您的下一個問題來自 RBC 的 Leonid Timashev。

Hey guys, thanks for taking my question. I just want to talk a little bit about the durability aspect again. Can you remind us, first of all, how you're measuring durability if patients start other medication after receiving COMP360 dose, and then I guess maybe the second part is On the more practical and real-world side, is it still a win that the patient starts like an SSRI or something after receiving their dose?

嘿夥計們，謝謝你們回答我的問題。我只是想再次談論耐用性方面。您能否提醒我們，首先，如果患者在接受 COMP360 劑量後開始服用其他藥物，您如何衡量耐久性，然後我想也許第二部分是從更實際和現實世界的角度來看，如果患者在接受劑量後開始服用 SSRI 或其他藥物，這仍然是一種勝利嗎？

I mean, how does the FDA think about that? And I guess how you guys are thinking you know in the future if someone chooses to start a different medication, maybe to retain their response rather than coming back to get another dose of COMP360. Thanks.

我的意思是，FDA 對此有何看法？我猜你們會想，將來如果有人選擇開始服用不同的藥物，也許是為了保留他們的反應，而不是回來服用另一劑 COMP360。謝謝。

I guess the most obvious way in which we see durability is that we know that we see a very early response and that we see in many cases that in the phase two study that that response was maintained as a change in the madras from baseline over many weeks, up to 12 weeks, as we followed patients.

我想，我們看到持久性的最明顯方式是，我們知道我們看到了非常早期的反應，並且我們在第二階段研究中的許多情況下看到，隨著我們對患者的跟踪，這種反應在數週內（最長可達 12 週）一直保持為馬德拉斯從基線的變化。

There is another sense, of course, in which one can look at durability, and you've implied it the time to an intervention for a new treatment. And we will be capturing that and indeed we captured that in our phase two, and that data will soon be publicly available in a publication. But that is one of the ways we will also be capturing the time for new treatment.

當然，還有另一種意義，我們可以從中觀察耐久性，並且您已經暗示了新治療介入的時間。我們將捕捉到這些，事實上我們在第二階段就捕捉到了這些，這些數據很快就會在出版物中向公眾公佈。但這也是我們爭取新治療時間的方法之一。

That new treatment in our study doesn't affect the conduct of the study. The patients remain with us and are followed up within our 52 week protocol. And what the FDA's attitude to that is not obviously something I can comment on. We will deliver the data to them and they'll reach a judgment, but I think I can speak from a clinical perspective that I wouldn't be surprised if patients who make a good symptomatic response.

我們研究中的新治療方法不會影響研究的進行。患者將留在我們這裡，並按照我們的 52 週方案接受追蹤。而 FDA 對此的態度顯然不是我可以評論的。我們會將數據提供給他們，他們會做出判斷，但我認為我可以從臨床角度說，如果患者出現良好的症狀反應，我不會感到驚訝。

May actually want to go on to maintenance antidepressants. I think that would be very unsurprising if that happened, and therefore it may very well be that that is one of the ways in which durability can be attained.

可能實際上想要繼續服用維持性抗憂鬱藥物。我認為如果發生這種情況，那不足為奇，因此這很可能是實現耐久性的方法之一。

Your next question is in the line of Francois Brisebois with Oppenheimer. Francois your line is open. Please make sure you do not have yourself on mute. There is no response from Francois's line. We'll go to the next question, Patrick Trucchio with H.C. Wainwright.

您的下一個問題是來自 Oppenheimer 的 Francois Brisebois 的。弗朗索瓦，您的線路已開通。請確保您沒有將自己設定為靜音。弗朗索瓦的電話沒有回應。我們進入下一個問題，由 H.C. 的 Patrick Trucchio 提問。溫賴特。

Thanks. Good morning. A couple of follow-up questions for me, I guess. The first one would just be on the COMP005 readout, what would be considered a clinically meaningful improvement in the Madras total score at six weeks, and how should we contextualize the results in relation to prior trials with psilocybin and other TRD treatments.

謝謝。早安.我想，我還需要問幾個後續問題。第一個問題只是關於 COMP005 讀數，什麼會被認為是六週時馬德拉斯總分具有臨床意義的改善，以及我們應該如何將結果與先前使用裸蓋菇素和其他 TRD 治療的試驗聯繫起來。

And Secondly, I was just wondering if you could provide some details on the psychological support model, the implementation, and how this, sort of is different from what we saw with the LICOs experience and just in terms of how we should think about the psychological support model from a regulatory perspective, but then also in terms of a, scale up and commercialization perspective.

其次，我想知道您是否可以提供一些關於心理支持模型、實施方案的細節，以及這與我們在 LICO 經驗中看到的有何不同，以及我們應該如何從監管角度看待心理支持模型，同時也從擴大規模和商業化的角度看待心理支持模型。

Thanks, Patrick. So a couple of questions in there and I'll hand to Guy, but just before that, just a reminder, you're not going to see the madras effect difference on the active arm. We're going to see the difference between the arms, just to be clear on that. So again, just a reminder that. But then let me pass to Guy to comment on that and initially on the psychological support side and then to Lori to talk about that from a scaling perspective.

謝謝，派崔克。這裡有幾個問題，我會交給 Guy 來回答，但在此之前，需要提醒的是，你不會在活動手臂上看到馬德拉斯效應的差異。我們將看看手臂之間的差異，只是為了更清楚地了解這一點。所以，再次提醒。但接下來請讓我先讓 Guy 對此進行評論，首先從心理支持方面談，然後請 Lori 從擴展的角度來談論這一點。

Yeah, I mean, I can't really add much more to what Kabir said on the difference because we weren't really reporting that as you've seen in our phase two study. The immediate change was of the order of 13 points on the madras, and of course we'd be very happy if we saw that again.

是的，我的意思是，我無法對 Kabir 所說的差異做出更多補充，因為正如您在第二階段的研究中看到的那樣，我們並沒有真正報告這一點。立即發生的變化是馬德拉斯的 13 點左右，當然，如果我們再次看到這種情況，我們會非常高興。

I think on the psychological support model, I think what it's important to understand is that what we're trying to do is to make it easy for the FDA to understand the drug's effects in isolation from any potential efficacy from psychotherapy. And so for that reason we have simplified the support we offer to patients so that it essentially gives them the information they need for the experience.

我認為，在心理支持模型中，重要的是要理解，我們正在努力讓 FDA 輕鬆了解藥物的效果，而無需考慮心理治療的任何潛在功效。因此，我們簡化了為患者提供的支持，以便從本質上為他們提供體驗所需的資訊。

It supports them on the day and it gives a chance for them to talk about it afterwards. We are systematizing our approach to a considerable degree, and we're monitoring all of the sessions so that we will be able to ensure that the people. Sitting with the patients do follow exactly what we have trained them to do, and what we have trained them to do is essentially to follow a protocol that is really unlike clinical practice.

它在當天為他們提供支持，並為他們提供事後談論的機會。我們正在很大程度上系統化我們的方法，我們正在監控所有的會議，以便我們可以確保人民。與患者坐在一起確實完全按照我們訓練他們所做的事情進行，而我們訓練他們所做的事情本質上是遵循與臨床實踐完全不同的協議。

And it's very much more about following a trial protocol, and that has required a certain amount of retraining, frankly for patients who come in with more assumptions about psychotherapy. So that's our approach to the trials. I'll pass to Lori, who may want to comment on the implications for clinic.

這在很大程度上是關於遵循試驗方案，坦白說，對於那些對心理治療有更多假設的患者來說，這需要一定程度的再訓練。這就是我們對待試驗的態度。我會把這個問題轉交給 Lori，她可能想評論一下這對診所的影響。

Yeah, I think you know what Guy said in terms of the purpose of the support model is that we are making sure that patients have support through, drug administration as well as prior to drug administration and after drug administration.

是的，我想你知道蓋伊所說的支持模式的目的，即我們要確保患者在給藥過程中以及給藥前和給藥後得到支持。

And at launch and hopefully to end up to scale up as well, we don't expect that to be very different than what the REMs requirements are for Travado right now and that that will only be limited to a licensed healthcare provider and we will not be constrained to therapists at the time.

在推出時以及最終擴大規模時，我們預計它不會與目前 REM 對 Travado 的要求有太大不同，並且僅限於有執照的醫療保健提供者，我們不會局限於治療師。

And just one thing to add, this is Steve Levine. It's also worth saying that to be trained in a new treatment or a new protocol is common across medicine, not just in psychiatry. And so this is also one of the areas where we're able to focus and learning from our strategic collaboration partners which encompass a handful of organizations that hundreds of sites to understand.

還有一點要補充，我是史蒂夫‧萊文。另外值得一提的是，接受新療法或新方案的訓練在整個醫學界都很常見，而不僅僅是在精神病學領域。因此，這也是我們能夠關注並向策略合作夥伴學習的領域之一，這些合作夥伴包括少數幾個組織和數百個站點。

Who is being trained within the organization right now, how they're being trained, how they allocate budgets for that training. So we'll be very informed in terms of real world training as we think about how this moves into real world care centers.

目前組織內誰正在接受培訓，他們如何接受培訓，他們如何為培訓分配預算。因此，當我們思考如何將其應用於現實世界的護理中心時，我們將在現實世界培訓方面獲得豐富的資訊。

Your next question is from the line of François Brisebois with Oppenheimer.

您的下一個問題來自奧本海默公司的 François Brisebois。

Sorry, can you guys hear me.

抱歉，你們聽得到我說話嗎？

Now? We can, François

現在？我們可以，弗朗索瓦

Oh, okay, wow, okay, sorry, I've had some IT issues and sorry if this was mentioned as well, but I was just wondering if you can, with Steve making a comment there just a little more on this role of Chief Patient Officer and what led to that and what exactly that implies. Thank you.

哦，好的，哇，好的，抱歉，我遇到了一些 IT 問題，如果也提到了這一點，我很抱歉，但我只是想知道您是否可以和史蒂夫一起對首席患者官這個角色以及導致這一角色的原因和確切含義發表一些評論。謝謝。

Thank you for asking that question. I'm very happy to answer that. As a psychiatrist, my background, I'm really happy to see that Compass has placed such an emphasis on ensuring that both the patient, particularly the patient, but both the patient and healthcare providers' perspectives are incorporated into everything we think about and plan whether it's the design of our trials or thinking ahead to a post-approval

感謝您提出這個問題。我很高興回答這個問題。作為一名精神科醫生，我很高興看到 Compass 如此重視確保患者（尤其是患者）和醫療保健提供者的觀點融入我們思考和計劃的一切之中，無論是試驗設計還是上市後思考

Environment where this actually is delivered to patients by licensed healthcare providers and so that's really broadly where I'm focused is involved widely across the organization in ensuring that those voices are reflected. And that there's a realistic perspective on what may be needed outside of the relatively rarefied environment of clinical trials as this moves into real world patient settings and actually gets to Patients.

在這種環境中，這些服務實際上是由持牌醫療保健提供者提供給患者的，因此，我真正關注的是整個組織的廣泛參與，以確保這些聲音得到反映。當這項技術進入現實世界的患者環境並真正惠及患者時，人們對於在相對稀薄的臨床試驗環境之外可能需要什麼有一個現實的看法。

Yeah, and I think, Frank, and I think it's self-evident that a psilocybin experience is a very difficult we talk about a paradigm changing.

是的，弗蘭克，我認為，裸蓋菇素體驗非常困難，這是不言而喻的，我們談論的是典範轉移。

Approach and it absolutely is a paradigm changing approach specifically from the point of view of the patient and that we're supporting some pretty vulnerable patient populations through welcoming a challenging experience. So having somebody of Steve's caliber and experience, really advocate for that and stand for that within the company we felt was really important and who better to have than Steve to do it.

這種方法絕對是一種範式轉移方法，特別是從患者的角度來看，我們透過歡迎具有挑戰性的體驗來支持一些相當脆弱的患者群體。因此，我們認為，擁有像史蒂夫這樣有能力和經驗的人，在公司內部真正倡導和支持這一點非常重要，而且有誰比史蒂夫更適合做這件事呢。

Okay, great. And then just on the 005 in terms of timing of 26 week data, can you just help us, just remind us what you're sharing here about Part A and enrollment and you know when 006 26 week comes out just how should we a best guess 005 26 week data after timing. Thank you.

好的，太好了。然後就 005 的 26 週數據時間而言，您能否幫助我們，提醒我們您在這裡分享的有關 A 部分和註冊的信息，並且您知道當 006 26 週出來時，我們應該如何對 005 26 週數據進行最佳猜測。謝謝。

So I'm happy to invite you to continue to guess, Frank. I mean what we have said clearly is the 26 weeks of 005 will be gated at a minimum on Part A completion of 006, as for 006. We've given a fairly wide range of guidance for the 26 weeks for now and the second half of 2026, but obviously as we get clearer on 006 enrollment and timelines, we're in a position to give more specific guidance also around the 26 weeks of 005, but for now we're not giving specific timing guidance around that.

所以我很高興邀請你繼續猜，弗蘭克。我的意思是，我們已經明確表示，005 的 26 週將至少在 006 的 A 部分完成時進行，至於 006。我們已經為目前的 26 週和 2026 年下半年提供了相當廣泛的指導，但顯然，隨著我們對 006 註冊和時間表的了解越來越清楚，我們也能夠為 005 的 26 週提供更具體的指導，但目前我們還沒有提供具體的時間指導。

Okay, I'll keep getting. Thank you.

好的，我會繼續。謝謝。

Your next question is from the line of Vikramruhiri with Morgan Stanley. Vikram, your line is open. There's no response. We'll go to the next question hello? We'll go to the next question. Sumant Kulkarni with Canaccord Genuity.

您的下一個問題來自摩根士丹利的 Vikramruhiri。維克拉姆，你的線路已開通。沒有回應。我們進入下一個問題你好？我們來討論下一個問題。Canaccord Genuity 的 Sumant Kulkarni。

Hi, thanks for taking our questions. I actually have three, so there was an earlier question on point separation on the Mater scale, but do you think that COMP360 might need to hit some higher bar relative to what is considered conventionally clinically relevant on Madras to be successful in the real world, or would the non-chronic dosing paradigm more than outweigh that scenario?

您好，感謝您回答我們的問題。我實際上有三個，所以之前有一個關於 Mater 量表上的點分離的問題，但您是否認為 COMP360 可能需要達到相對於馬德拉斯傳統臨床相關的更高標準才能在現實世界中取得成功，或者非慢性給藥範例是否會超過這種情況？

So I'll have the guy, but just as a reminder, I mean this is TRD Sumant, not MDD, and you know there's precisely two approved drugs in TRD. I mean this is Guy.

所以我會找這個人，但提醒一下，我的意思是這是 TRD Sumant，而不是 MDD，而且你知道 TRD 中恰好有兩種核准的藥物。我的意思是這是蓋伊。

Well, I think that's the honest answer actually that the land the yardstick doesn't really exist to anything like the extent that it exists in MDD. Is there anything else we should say on that? I mean

嗯，我認為這實際上是誠實的回答，土地標準實際上並不存在，就像在 MDD 中存在的程度一樣。關於這一點我們還有啥要說的嗎？我是說

No,So it's a lower bar.

不，所以標準較低。

Yes, if anything, it will be a lower bar for TRD versus MDD.

是的，如果有的話，TRD 與 MDD 的標準會更低。

Understood. So now with the understanding that COMP360 is relatively far ahead in your terms, in terms of your potential ability to get to the market, how's your thinking involved on how the product might be able to compete with other psychedelic compounds that require shorter times in the clinic given that we've seen some phase two data from 5 DMT, for example?

明白了。那麼，現在您了解到 COMP360 在進入市場的潛在能力方面處於相對領先的地位，鑑於我們已經看到了 5 DMT 的一些第二階段數據，您如何看待該產品如何與需要更短臨床時間的其他迷幻化合物競爭？

Hi, this is Steve. I'll take that one. Thank you. I think in terms of considering what drives decision making from healthcare providers, amongst many considerations, key amongst them are the economics, whether this is an economically viable and hopefully attractive proposition for them. And so with that, it really highlights the work that we did on procuring new category three CPT codes.

你好，我是史蒂夫。我要那個。謝謝。我認為，在考慮醫療保健提供者的決策因素時，有許多考慮因素，其中最關鍵的是經濟因素，即這對他們來說是否是一個經濟上可行且有吸引力的提議。因此，它真正凸顯了我們在採購新的三類 CPT 代碼方面所做的工作。

Which are specific for the administration day and the support provided on that day. And as a reminder, those codes can be used across a range of psychedelic treatments if approved, and they're reported on an hour by hour basis. And so regardless of the length of the treatment, we anticipate that healthcare providers will be reimbursed for the providers for the services provided.

這些都是針對管理日和當天提供的支援。提醒一下，如果獲得批准，這些代碼可用於多種迷幻治療，並且會按小時報告。因此，無論治療時間長短，我們都預期醫療保健提供者將獲得所提供服務的補償。

I also just want to add, if you don't mind that, we need to think about the indications that some of these will be approved for. And right now, TRD our indication will be the only TRD on the product for quite some time, regardless of the psychedelic.

我還想補充一點，如果您不介意的話，我們需要考慮其中一些將被批准的跡象。而現在，無論是否具有迷幻效果，我們的適應症 TRD 將在相當長的一段時間內成為該產品上唯一的 TRD。

Got it. And my last question, there seems to be some enthusiasm around support for psychedelic medicines at very high levels in the current political environment, but how would you say that any changes either in terms of personal or personnel or morale at the FDA have affected the tone of your recent interactions with the agency, if any.

知道了。我的最後一個問題是，在當前的政治環境下，似乎高層人士對支持迷幻藥物表現出一定的熱情，但您認為 FDA 在個人、人員或士氣方面的變化如何影響了您最近與該機構的互動基調（如果有的話）。

Or any predictions you might have there on what that might mean as you head into a potential regulatory process here?

或者，當您進入潛在的監管流程時，您對這可能意味著什麼有什麼預測？

Thank you, Sumant. It is a great question, and I mean the straight answer is we don't yet know, to be clear, but obviously we are tracking things very closely.

謝謝你，蘇曼特。這是一個很好的問題，我的意思是直接的答案是我們還不知道，但顯然我們正在密切關注事態發展。

I think our overall perspective is at worst some of these changes are neutral and potentially there's some positive tailwinds in this. And if you think about an area we haven't really focused on, for instance, PTSD, the combination of that, the influence of veterans organizations, and so on, you can see that clearly in that space that could be a tailwind. So far in terms of FDA interaction, there is no change for us to comment on.

我認為我們的總體觀點是，在最壞的情況下，其中一些變化是中性的，並且可能帶來一些積極的順風。如果你考慮我們還沒有真正關注的領域，例如創傷後壓力症候群 (PTSD)，以及兩者的結合、退伍軍人組織的影響等等，你可以清楚地看到，在那個領域，這可能是一個順風。到目前為止，就 FDA 互動而言，還沒有任何變化值得我們評論。

Thank you, that's very helpful.

謝謝，這非常有幫助。

Your next question is from the line of Jason McCarthy with Maxim Group.

您的下一個問題來自 Maxim Group 的 Jason McCarthy。

Hey guys, this is Michael Okunewitch on the line. Thank you so much for taking my questions today. I guess just to start off, I'd like to see if you could talk a little bit more about your pipeline plans. You did mention you're designing a late stage study in PTSD. You talk about some of the other indications that you're working on. I know anorexia has been a target for a while.

大家好，我是 Michael Okunewitch。非常感謝您今天回答我的問題。首先，我想看看您是否可以再多談談您的管道計劃。您確實提到您正在設計一項關於 PTSD 的後期研究。您談到了您正在研究的一些其他跡象。我知道厭食症已經成為人們關注的焦點。

Sure, so the anorexia study, we have completed that closed enrollment, and we will expect to see data sometime in 2025 on that. We have a number of IISs that we've conducted in the past that have given us interesting signals and other indications, but right now from, a full steam development ahead, our focus is on TRD and PTSD.

當然，對於厭食症研究，我們已經完成了封閉式招生，我們預計將在 2025 年的某個時候看到相關數據。我們過去進行過多次 IIS，這些研究給了我們有趣的信號和其他跡象，但從目前全速發展的角度來看，我們的重點是 TRD 和 PTSD。

All right, thank you. And then I want to see if you could comment on, just given the recent rise we've seen in adoption on Travado, it did more than a billion dollars this year. Do you think that having another interventional psychiatric therapeutic NTRD could help prepare the market for something like COMP360?

好的，謝謝。然後我想看看您是否可以評論一下，鑑於我們最近看到的 Travado 採用率的增長，今年它的銷售額已超過 10 億美元。您是否認為，另一種介入性精神病治療 NTRD 可以幫助市場為 COMP360 之類的產品做好準備？

We absolutely do. So J&J has done a great job of really preparing and educating HDPs on what TRD actually is. And as a reminder, TRD is broadly referred to as the failure of two prior antidepressants. And what we are seeing, and what we're thinking about with Travado is if you think about the addressable patient population, which is probably around about 3 million MDD patients right now, Travado has less than 2% of patients in that TRD patient population.

我們絕對相信。因此，強生公司在為 HDP 做好充分準備並教育他們了解 TRD 的真正意義方面做得非常出色。需要提醒的是，TRD 被廣泛認為是先前兩種抗憂鬱藥物的失敗。而我們所看到的，以及我們對 Travado 的思考是，如果你考慮可尋址的患者群體，目前大概有 300 萬 MDD 患者，那麼 Travado 在 TRD 患者群體中所佔患者比例不到 2%。

So any, additional, success on the bravado side only, bodes well for us coming to market.

因此，任何額外的、僅在虛張聲勢方面的成功，都預示著我們進入市場是一個好兆頭。

All right, thank you very much for taking my questions and congrats on the progress.

好的，非常感謝您回答我的問題，並祝賀您的進展。

Thanks, Mike.

謝謝，麥克。

Your next question is from the line of Vikram Purohit with Morgan Stanley.

您的下一個問題來自摩根士丹利的 Vikram Purohit。

Hi everyone, can you hear me?

大家好，聽得到我說話嗎？

Yes,

是的，

Great, this is [Morgan] on for Vikram. So two from us for PTSD. One, could you walk us through how you prioritize PTSD over the other indications like bipolar disorder that you're exploring in different IISs. And then on the path to filing for PTSD, what do you imagine that looking like in terms of studies, patients, number of patients, and what level of follow up data do you think is needed? Thank you.

太好了，這是 Vikram 的 [Morgan]。我們有 2 人患有 PTSD。首先，您能否向我們介紹一下，您如何優先考慮 PTSD，而不是您在不同 IIS 中探索的雙相情感障礙等其他適應症。那麼，在申請 PTSD 的過程中，您認為在研究、患者、患者數量方面會是什麼樣子，您認為需要什麼程度的後續數據？謝謝。

Yes, thanks, [Morgan]. So I mean, I think. PTSD, as you'll be aware, nothing has been approved for more than 20 years in PTSD. So it's in terms of true unmet need, the scale of the problem, and kind of the intensity of the focus around the problem.

是的，謝謝，[摩根]。所以我的意思是，我認為。PTSD，如您所知，20 多年來，PTSD 領域沒有任何藥物獲得批准。因此，這與真正未滿足的需求、問題的規模以及圍繞問題的關注強度有關。

It was clear to us that particularly having seen the signal in our phase 2A, this was an area that both from a medical and therefore from a commercial perspective. Rose absolutely to the top of the priority list. So that's hence the focus on PTSD ahead of any other indication. I'll have to guide to talk a little more regulatory side.

我們很清楚，特別是在看到我們第 2A 階段的訊號後，這是一個從醫學角度和商業角度都值得關注的領域。絕對是上升到了優先清單的首位。因此，我們對 PTSD 的關注度高於對其他任何跡象的關注度。我必須引導大家多談一些監管上的問題。

Yes, I mean, we are obviously in the process of thinking carefully about that. I can't say that we're yet fixed on one way to go. I mean we expect to have a meeting with the FDA to thrash that out at some point, and we've obviously developed a number of scenarios with the way we could actually develop the treatment in PTSD, I mean the patient population.

是的，我的意思是，我們顯然正在仔細思考這個問題。我不能說我們已經確定要走的路了。我的意思是，我們預計將與 FDA 舉行會議來討論這個問題，而且我們顯然已經制定了一些方案，以便我們能夠實際開發 PTSD 治療方法，我的意思是針對患者群體。

We're also going to have a little bit of guidance of the from the FDA's attitude from the adcom that's going to take place for Brexpiprazole, which we'll obviously be following, and that will maybe give us some insight into the way the patient population in particular is observed. So yeah, we're looking forward to an exciting year with this.

我們還將獲得一些來自 FDA 對 Brexpiprazole 的審批委員會的態度指導，我們顯然會遵循這些指導，這也許會讓我們深入了解特別是患者群體的觀察方式。是的，我們期待著令人興奮的一年。

I mean, the other indications that you mentioned, for example, bipolar II disorder, a little more difficult simply because of co-medication and the complexity of the condition. PTSD, as Kabir has indicated, has this massive unmet need. There are very little available, and we have this really very encouraging data that's so durability after a single administration. So I think that's clearly the first place to go. We have no doubt in our minds about that.

我的意思是，您提到的其他症狀，例如雙相情感障礙 II，由於同時用藥和病情的複雜性，治療起來會稍微困難一些。正如卡比爾所指出的，創傷後壓力症候群 (PTSD) 存在大量未滿足的需求。可用的數據非常少，但我們獲得的這些確實非常令人鼓舞的數據表明，在一次管理之後，其持久性非常強。所以我認為這顯然是第一個要去的地方。我們對此深信不疑。

Yeah, [Morgan], hey, it's Lori. If you don't mind, I'll just add a little bit of additional colour. It is a very highly prevalent population as well. There are about 13 million patients out there and as Guy mentioned, very limited op options. There are actually only two FDA approved products for PTSD right now. And as Kabir mentioned, it's been a very long time since innovation has happened in the market.

是的，[摩根]，嘿，我是洛瑞。如果您不介意的話，我只需添加一點額外的顏色。這也是一個非常普遍的群體。目前大約有 1300 萬名患者，但正如 Guy 所提到的，手術選擇非常有限。目前實際上只有兩種經 FDA 核准的治療 PTSD 的產品。正如卡比爾所說，市場已經很久沒有創新了。

Thank you.

謝謝。

Your next question is from the line of Francois Brisebois with Oppenheimer.

您的下一個問題來自 Oppenheimer 的 Francois Brisebois。

Hey, sorry, just an extra one here on the DSMB side, the comment you made that you just had recently, you remind us what exactly you said of how recent that interaction was and being 90% enrolled, is it fair to assume that there are no more DSMB looks at this until a readout, or could there be one more?

嘿，抱歉，DSMB 方面還有一個額外的問題，您剛才發表的評論提醒了我們，您剛才說過那次互動是最近發生的，而且註冊率高達 90%，是否可以公平地假設，在讀數之前 DSMB 不會再關注這個問題，或者還會再關註一次？

So as in recent it's this month as it was in February, so that's how recent the loss is, I guess you know. As to the kind of the quarterly cadence versus when we actually have top line in hand that we will see what happens in the course of next quarter, but I mean the regular cadence is quarterly.

所以最近這個月的情況和二月的情況一樣，這就是最近的損失，我想你知道的。至於季度節奏，以及我們實際掌握的頂線情況，我們將看看下個季度會發生什麼，但我的意思是常規節奏是每季一次。

At this time there are no further questions. I will now have the call back over to management for closing remarks.

目前沒有其他問題。我現在將電話轉回管理階層，請他們作最後發言。

Thanks very much. So thanks everyone for your time and attention today. As we said, we're at the start of a very exciting couple of years for Compass with multiple data readouts between now and the latter part of 2026, and in particular we're excited about the top five line that we expect to see towards the end of next quarter. So, thanks everyone. Thanks for your time.

非常感謝。感謝大家今天的時間和關注。正如我們所說，對於 Compass 來說，我們正處於非常令人興奮的幾年的開始，從現在到 2026 年下半年將有多個數據讀數，特別是我們對預計在下個季度末看到的前五名感到興奮。所以，謝謝大家。感謝您的時間。

This concludes today's call. Thank you for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的加入。現在您可以斷開線路了。