Compass Pathways PLC (CMPS) 2025 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the Compass Pathways first quarter 2025 earnings call. Please note that this call is being recorded. After the speaker's prepared remarks, there will be a question-and-answer session. (Operator Instructions)

女士們，先生們，感謝你們的支持，歡迎參加 Compass Pathways 2025 年第一季財報電話會議。請注意，本次通話正在錄音。演講者發表準備好的演講後，將有一個問答環節。（操作員指示）

Thank you. I'd now like to hand the call over to Steve Schultz, Senior Vice President of Investor Relations. You may now begin, sir.

謝謝。現在我想將電話交給投資者關係高級副總裁史蒂夫舒爾茨。先生，現在可以開始了。

Welcome all of you. And thank you for joining us today for our first quarter 2025 results conference call. Again, my name is Steve 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; and Dr. Steve Levin, our Chief Patient Officer, will be available for the Q&A.

歡迎大家的光臨。感謝您今天參加我們的 2025 年第一季業績電話會議。再次聲明，我叫史蒂夫‧舒爾茨 (Steve Schultz)，Compass Pathways 投資人關係資深副總裁。今天，與我們一起出席的還有我們的執行長 Kabir Nath；我們的財務長 Teri Loxam 也將準備演講稿。此外，我們的首席醫療官 Guy Goodwin 博士；我們的首席患者官史蒂夫·萊文博士將參加問答環節。

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.

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。

Before we begin, we 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. You should not place undue reliance on these forward-looking statements.

在我們開始之前，我們提醒大家，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。您不應過度依賴這些前瞻性陳述。

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 quarterly report on Form 10 filed with the US Securities and Exchange Commission and in subsequent filings made by Compass with the SEC.

由於各種風險、不確定性和其他因素，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存在重大差異，包括我們向美國證券交易委員會提交的最新 10 號表格季度報告以及 Compass 向美國證券交易委員會提交的後續文件中風險因素標題下所述的風險和不確定性。

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 statements, even if our estimates or assumptions change. I will now hand the call over to Kabir.

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。我們明確否認有任何更新或修改任何前瞻性陳述的義務，即使我們的估計或假設發生變化。我現在將通話交給卡比爾。

Thank you, Steve. Good day, everyone. And thank you for joining us. Recently, we announced the completion of dosing of all participants in Part A of our 005 trial, the first of two pivotal Phase 3 trials, which marks an important milestone in our mission to address the pressing unmet need in treatment resistant depression or TRD.

謝謝你，史蒂夫。大家好。感謝您加入我們。最近，我們宣布完成了 005 試驗 A 部分所有參與者的給藥，這是兩項關鍵 3 期試驗中的第一項，這標誌著我們解決難治性憂鬱症或 TRD 中緊迫的未滿足需求的使命的一個重要里程碑。

We look forward to sharing the six week top line results in late June. As we've guided before, these results will include three key efficacy measures for the six-week primary endpoint. The difference between the treatment arm and the placebo arm in change from baseline on MADRS, the associated p-value and confidence interval

我們期待在六月下旬分享六週的頂線結果。正如我們先前所指導的，這些結果將包括六週主要終點的三個關鍵療效指標。治療組和安慰劑組在 MADRS 評分中相對於基線的變化差異、相關的 p 值和置信區間

A positive treatment effect of six weeks based on a single dose of COMP360 would represent a meaningful improvement in durability compared with the very limited options available to TRD patients today. From a safety standpoint, the independent DSMB reviews unblinded safety data on a regular basis and has been doing so since the trial started.

與目前 TRD 患者可用的非常有限的選擇相比，單劑量 COMP360 的六週積極治療效果將代表持久性的顯著改善。從安全角度來看，獨立的 DSMB 定期審查未盲安全數據，並且自試驗開始以來一直這樣做。

Since the trial remains blinded through 26 weeks, we have requested the DSMB to provide a comment on suicidality. We believe that these data, if positive, should provide investors with further clinical validation of COMP360's treatment potential in TRD.

由於該試驗在 26 週內仍處於盲態，我們已請求 DSMB 對自殺傾向發表評論。我們相信，如果這些數據是積極的，應該為投資者提供 COMP360 在 TRD 治療潛力的進一步臨床驗證。

The second Phase 3 trial, 006, which has three active arms, could further define the COM 360 profile with data on a second initial treatment which we believe could potentially extend durability or deepen response. Enrollment is going well in 06, and I'll remind you that that is a global trial and we're on track for the 26-week results in the second half of 2026.

第二階段 3 期試驗 006 有三個活躍組，可以透過第二次初始治療的數據進一步定義 COM 360 概況，我們相信這可能會延長持久性或加深反應。06 年的招生工作進展順利，我要提醒大家，這是一項全球性試驗，我們預計在 2026 年下半年獲得 26 週的結果。

Also, during this quarter, 52 weeks safety and efficacy data from the CO 004 study was published in the Journal of Clinical Psychology. This was an observational 52 week follow up from the Phase 2b 001 and 003 trials of COMP360 synthesized psilocybin treatment in 252 patients with TRD.

此外，本季度，CO 004 研究的 52 週安全性和有效性數據發表在《臨床心理學期刊》。這是對 252 名 TRD 患者進行 COMP360 合成裸蓋菇素治療的 2b 期 001 和 003 試驗的為期 52 週的觀察性追蹤。

This study showed that for the full patient population, a single 25 mg COMP360 psilocybin dose offered long term benefits with an average time to depressive event of over 12 weeks.

這項研究表明，對於所有患者來說，單劑量 25 毫克 COMP360 裸蓋菇素均可帶來長期益處，平均憂鬱事件發生時間超過 12 週。

A post hoc analysis of the subset of 58 participants that continued in the long-term follow-up study shown time to depressive event for those patients treated with 25 milligrams was substantially longer at 189 days. While there may be some responder bias associated with this subgroup, this is impressive data in a difficult to treat and highly refractory patient population.

對參與長期追蹤研究的 58 名參與者子集進行的事後分析顯示，接受 25 毫克治療的患者的憂鬱事件發生時間明顯更長，為 189 天。雖然該亞組可能存在一些反應者偏見，但對於難以治療和高度難治的患者群體來說，這是令人印象深刻的數據。

And we believe shows the potential of COM 360 to be a clinically differentiated treatment that is both rapid acting and with meaningful durability. The phase 3 program is designed to confirm the durability and safety profile which, if successful and approved, could be a groundbreaking option for individuals who suffer from TRD.

我們相信 COM 360 具有成為臨床差異化治療方法的潛力，它不僅起效迅速，而且具有顯著的持久性。第三階段計劃旨在確認其耐用性和安全性，如果成功並獲得批准，這可能成為患有 TRD 的個人的突破性選擇。

In addition, as we plan for the commercialization of COM 360, We'd be working to ensure that we understand the commercial opportunity initially by focusing on how CO 360 will be delivered in a broad spectrum of settings of care.

此外，當我們規劃 COM 360 商業化時，我們將努力確保我們首先了解商業機會，重點關注如何在廣泛的護理環境中提供 CO 360。

One way we are achieving this is through developing relationships with various provider types through our strategic collaborations, which we previously discussed. In line with this, we announced an additional strategic collaboration this quarter with HealthPort.

我們實現這一目標的一種方法是透過我們之前討論過的策略合作與各種類型的供應商建立關係。為此，我們本季宣布與 HealthPort 建立額外的策略合作關係。

HealtPort is a community health center that serves low income individuals and is focused on providing broad and equitable access to innovative mental health treatments, which could potentially include COMP360 if approved by the FDA. HealthPort is our first collaboration that is focused on community-based delivery to underserved patient populations.

HealtPort 是一家為低收入者提供服務的社區健康中心，致力於為人們提供廣泛、公平的創新心理健康治療機會，如果獲得 FDA 批准，其中可能包括 COMP360。HealthPort 是我們首次合作，致力於為服務不足的患者群體提供社區服務。

Beyond this, our efforts with our existing collaborations are generating considerable value. We have gained deep insights into the patient experience and care pathways for those living with TRD within high volume interventional psychiatry practices, hospital systems and integrated delivery networks.

除此之外，我們與現有合作夥伴的努力正在產生巨大的價值。我們對大量介入精神科實踐、醫院系統和綜合交付網絡中 TRD 患者的患者體驗和護理途徑有了深入的了解。

We've strengthened our understanding of the clinical, operational, economic and administrative considerations of implementing and scaling analogous interventional psychiatry treatments such as Spravato.

我們加強了對實施和擴展類似 Spravato 介入精神病治療的臨床、操作、經濟和行政考慮的理解。

This enables us to understand and prepare for the launch and adoption of COMP360 if approved. And we're building a strong appreciation of how training and continued education is being delivered and how best to integrate COMP360 in the post approval setting. These are just a few of the many examples of meaningful insights that we are using to inform our strategy for launch and post launch scaling. Now let me turn the call to Teri.

這使我們能夠了解並為獲得批准後 COMP360 的推出和採用做好準備。我們正在深入理解如何開展培訓和繼續教育，以及如何在審批後環境中最好地整合 COMP360。這些只是我們用來指導發布和發布後擴展策略的眾多有意義的見解中的一小部分。現在讓我把電話轉給 Teri。

Thank you, Kabir. After our January financing, we are in a very strong financial position. At the end of March, we had cash and cash equivalents of $260 million which we expect to fund our operations at least through the planned 26-week data readout from our second phase 3 trial, CO 006, which is expected in the second half of 2026.

謝謝你，卡比爾。經過一月份的融資，我們的財務狀況非常強勁。截至 3 月底，我們擁有 2.6 億美元的現金和現金等價物，預計這些資金至少可以為我們的營運提供資金，以支持我們第二階段 3 期試驗 CO 006 計劃進行的 26 週數據讀取，該試驗預計將於 2026 年下半年進行。

This compares with $165 million at the end of 2024. Debt under the Hercules loan facility was $30.5 million at the end of the first quarter. Cash used in operations for the first quarter was $45.7 million and we expect net cash used in operations for the full year 2025 to be within the range of $120million to $145 million.

相較之下，2024 年底這一數字為 1.65 億美元。第一季末，Hercules 貸款債務為 3,050 萬美元。第一季營運現金使用量為 4,570 萬美元，我們預計 2025 年全年營運淨現金使用量將在 1.2 億美元至 1.45 億美元之間。

Again, as Kabir said earlier, we eagerly await the results of our first phase 3 data as we know you're waiting for it as well. As a reminder, this is the first of 3 expected data readouts from this program over the next 18 months.

再次，正如 Kabir 之前所說，我們熱切地等待第一階段 3 數據的結果，因為我們知道您也在等待它。提醒一下，這是該計劃在未來 18 個月內預計的 3 次數據讀數中的第一個。

Based on our data to date, including the recent 52 week follow up data from our phase 2b trial, we believe COMP360 could represent a clinically differentiated treatment option. That is rapid acting with the potential for paradigm changing durability.

根據我們迄今為止的數據，包括我們 2b 期試驗最近 52 週的追蹤數據，我們相信 COMP360 可能代表一種臨床差異化的治療選擇。這是快速行動，具有改變範式持久性的潛力。

We also continue to work toward a final design for our late-stage clinical program in PTSD and look forward to updating investors when that design is finalized. Given the high unmet need and limited current treatment options, we see a significant commercial opportunity in PTSD.

我們也將繼續致力於 PTSD 後期臨床專案的最終設計，並期待在設計最終確定後向投資者通報最新情況。鑑於未滿足的需求量很大且目前的治療選擇有限，我們認為 PTSD 領域存在巨大的商業機會。

With that we're going to move to Q&A and as a reminder, Dr. Guy Goodwin and Dr. Steve Levine are also with us today for the Q&A portion.

接下來我們將進入問答環節，提醒一下，蓋伊·古德溫博士和史蒂夫·萊文博士今天也將參加問答環節。

And with that, let me turn it back over to the operator.

說完這些，讓我把麥克風交還給接線生。

We are now opening the floor for question-and-answer session. (Operator Instructions)

我們現在開始問答環節。（操作員指示）

Your first question comes from the line of Leonid Timashev of RBC Capital Markets. Your line is now open.

您的第一個問題來自 RBC Capital Markets 的 Leonid Timashev。您的線路現已開通。

Hi, this is Kevin on for Leonid. Thank you for taking our questions.

大家好，我是 Kevin，代表 Leonid。感謝您回答我們的問題。

So, you recently, as you mentioned, published longer term follow up data from the Phase 2. Maybe can you just highlight the key takeaways in your view on durability as well as what you may have learned about which dose is most appropriate?

因此，正如您所提到的，您最近發布了第二階段的長期追蹤數據。也許您能否強調一下您對耐用性的看法中的關鍵點，以及您可能了解到的關於哪種劑量最合適的知識？

Thank you very much.

非常感謝。

Thanks, Kevin, this is, just checking that you can hear us clearly.

謝謝，凱文，這只是確認你能聽清楚我們說話。

Yes, I can.

是的，我可以。

I'll hand actually to Guy to take the lead on that then, please.

那麼，請讓蓋伊 (Guy) 主導此事。

I mean, Kevin, this data is not as complete as we would like it to have been. So I'd like to start with that disclaimer really. It's not a definitive study, a definitive follow-up study by any means for various reasons. But what it does show is a difference between the durability of the three doses. This is most clearly seen in the subgroup who completed the study.

我的意思是，凱文，這些數據並不像我們希望的那樣完整。因此，我真正想從這個免責聲明開始。由於各種原因，它不是一個權威的研究，也不是一個權威的後續研究。但它確實顯示出三種劑量的持久性之間的差異。這在完成研究的亞組中表現得最為明顯。

And they, as we mentioned earlier, are a little unrepresentative, but nevertheless they did demonstrate some patients who received 25 milligrams can last as long as six months following treatment. And that is much less likely in people who've received lower doses.

正如我們之前提到的，它們有點不具代表性，但它們確實表明，一些接受 25 毫克治療的患者在治療後可以存活長達六個月。而對於接受較低劑量治療的人來說，這種情況發生的可能性要小得多。

So, I think it reiterates our conclusion from the Phase 2 study that 25 milligrams are, for the time being, the preferred dose that we think, which should carry forward and will be the one that we obviously used in the Phase 3 program.

因此，我認為這重申了我們在第二階段研究中得出的結論，即 25 毫克暫時是我們認為的首選劑量，應該繼續使用，並且顯然會成為我們在第三階段計劃中使用的劑量。

Thank you.

謝謝。

Next question comes from the line of Paul Matteis of Stifel. Your line is now up.

下一個問題來自 Stifel 的 Paul Matteis。您的線路現已通電。

Hey, good morning. Thanks for taking my question. I appreciate it. I mean, obviously, with the top line disclosure and your guys' conservatism around trying to not bias the 006 trial, it's going to be difficult to compare across studies, which is totally reasonable.

嘿，早安。感謝您回答我的問題。我很感激。我的意思是，顯然，由於頂線披露和你們試圖不影響 006 試驗的保守態度，跨研究進行比較將會很困難，這是完全合理的。

But just as it relates to thinking about the actual efficacy delta on MADRS, one challenge in the psychedelics space is just a high degree of variability and placebo effect across trials. What is your base case -- again, the study is blinded, but what was your base case and what the placebo effect might be in this study? And how might that kind of inform the way we contextualize this effect size versus what others have observed?

但就像思考 MADRS 上的實際療效增量一樣，迷幻藥領域的一個挑戰就是試驗過程中的高度變異性和安慰劑效應。您的基準情況是什麼——再次強調，這項研究是盲法的，但您的基準情況是什麼？這項研究中的安慰劑效應可能是什麼？那麼，我們如何才能將這種效應大小與其他人觀察到的進行比較呢？

Thank you.

謝謝。

Yeah, thank you for that question. I mean we our estimate, our guesstimate, I think you'd have to call it, was really based on what we saw in a previous study of MDD from Switzerland, which was with COMP360. And looking at our own data, our own data, obviously was from an arm, which received one milligram.

是的，謝謝你的提問。我的意思是，我們的估計，我們的猜測，我想你必須這樣稱呼它，實際上是基於我們之前在瑞士與 COMP360 合作進行的 MDD 研究中所看到的情況。查看我們自己的數據，我們自己的數據顯然來自一隻手臂，它接受了一毫克。

So we considered whether or not patients in that population had a psychedelic experience or not or anything approaching a psychedelic experience. And so, we took account of the subgroup who seemed to us to have the lowest experience and looked at their responses in estimating what the placebo was likely to be. I think in this field, we generally expect to see in well conducted trials a placebo response. The placebo arm does not receive nothing.

因此，我們考慮該族群中的患者是否有過迷幻體驗，或是否有任何接近迷幻體驗的經驗。因此，我們考慮了那些在我們看來經驗最少的亞群，並根據他們的反應來估計安慰劑可能的作用。我認為在這個領域，我們通常期望在良好進行的試驗中看到安慰劑反應。安慰劑組不接受任何治療。

They receive a great deal of attention, have frequent hospital visits, it's construed in a very positive way by patients. And so, you would expect a placebo response, you would respect expect also regression to the mean. So, the normal expectation is for there to be a placebo response.

他們受到了極大的關注，經常去醫院就診，患者對此也持非常積極的態度。因此，您會期待安慰劑反應，您也會期待回歸均值。因此，正常的預期是會出現安慰劑反應。

And obviously, the difference you see between placebo and the active arm can be attributed to the effect of the drug, which is the key thing that we're wanting to prove. And as we've indicated, we would be very pleased to see effects of over three on the MADRS scale. We think that is clinically significant, anything above that is a bonus.

顯然，安慰劑組和活性組之間的差異可以歸因於藥物的作用，這是我們想要證明的關鍵。正如我們所指出的，我們很高興看到 MADRS 量表上超過三項的效果。我們認為這具有臨床意義，任何高於這個意義的事情都是額外的獎勵。

Okay, great. And if I could ask one follow-up question just on the DSMB commentary on the presence or lack of a suicidality signal. Ultimately, I guess, where do you think you guys or the DSMB might draw the line between an actual signal and noise, right? Like I would imagine two events versus one event could be kind of codified as noise. But is there any I guess, to the outside looking at it seems like there's an art to this, there's an element of subjectivity. How should we interpret that?

好的，太好了。我可以就 DSMB 對自殺傾向訊號存在與否的評論提出一個後續問題嗎？最終，我猜，您認為您或 DSMB 會如何劃分實際訊號和雜訊之間的界限，對嗎？就像我想像的兩個事件與一個事件可以被編碼為噪音。但我想，從外部來看，這似乎是一門藝術，有主觀因素。我們該如何解讀這一點？

I mean that is a practice of medicine question really, because what the -- we're asking the DSMB to do is to take a judgment that is based, not just on the current event and the relative frequencies, but also the severity, the timing, the way in which the event evolves and may, in fact, resolve.

我的意思是，這實際上是一個醫療實踐問題，因為我們要求 DSMB 做出的判斷不僅基於當前事件和相對頻率，還基於事件的嚴重性、時間、發展方式以及實際上可能解決的方式。

And all of those factors, I think, weigh, and if I were doing the job and I have in the past for a company, that would weigh in how I reported the likely probability that there was an imbalance in the two arms, which is what we're asking the DSMB to do.

我認為，所有這些因素都會產生影響，如果我正在做這項工作，而且我過去也曾為一家公司做過這項工作，那麼這些因素都會影響我如何報告兩個部門存在不平衡的可能性，而這正是我們要求 DSMB 做的事情。

So, it's a nuanced judgment. It cannot be done on the basis of the scale. It can't be done on the base of numbers. It has to be done on the basis of a complete assessment of the picture for each of the individual instances.

所以，這是一個微妙的判斷。不能按照規模來做。僅憑數字是無法做到這一點的。這必須在對每個單獨實例進行完整評估的基礎上完成。

Fair enough, thank you very much.

很好，非常感謝。

Next question comes from the line of Charles Duncan of Cantor. Your line is now open.

下一個問題來自 Cantor 的查爾斯鄧肯 (Charles Duncan)。您的線路現已開通。

Hey, good morning, Kabir and team.

嘿，早上好，卡比爾和團隊。

Congrats on the progress. Thanks for taking the question. I wanted to ask another question about suicidality. And I'm kind of wondering if, back when you were designing this study, was that something that the FDA was more concerned about or were you hearing concerns or thoughts about that from the broader, call it, investment community? And what is the background rate that you were considering when conducting the study given this TRD population?

恭喜你取得進展。感謝您回答這個問題。我想問另一個有關自殺傾向的問題。我想知道，當您設計這項研究時，這是否是 FDA 更關心的事情，或者您是否聽到了更廣泛的投資界對此的擔憂或想法？針對這個 TRD 族群，您在進行研究時考慮的背景率是多少？

Hi, Charles, thank you. The issue of suicidality was not addressed directly or brought up by the agency in our discussions with them. Suicidality is a core feature of depression. All trials of either MDD or TRD have to include patients with some degree, either a history of suicidality or current passive suicidality to exclude it as a factor entirely is simply to distort the population in a way that it ceases to be representative of the target population.

你好，查爾斯，謝謝你。在我們與該機構的討論中，他們並沒有直接提及或提及自殺傾向的問題。自殺傾向是憂鬱症的核心特徵。所有 MDD 或 TRD 試驗都必須納入具有一定程度自殺傾向的患者，無論是有自殺史還是當前有被動自殺傾向，將其完全排除在外只會扭曲人群，使其不再代表目標人群。

So suicidality is a fact that everybody has to contend with in designing and executing these studies. It arose as an issue, as you may remember, after we released the data from 001 and the fact that we had an imbalance in the number of behavioral actions related to suicidality, all of them somewhat delayed from the actual treatment, that and the 25-milligram arm, that produced a good deal of commentary and seems never to have left us.

因此，在設計和執行這些研究時，自殺傾向是每個人都必須面對的事實。您可能還記得，在我們發布 001 的數據後，出現了一個問題，即與自殺傾向相關的行為動作數量不平衡，所有這些行為動作都與實際治療有一定延遲，而 25 毫克組則引發了大量評論，而且似乎從未離開過我們。

So, we live with this continues and that is obviously something we remain seriously concerned about. We wish to monitor carefully in the Phase 3 and to generate the numbers that will give us confidence about the actual potential for differences between the three arms. Our expectation is that there will not be important differences between the three arms.

因此，我們只能忍受這種情況的持續，這顯然是我們仍然嚴重擔憂的事情。我們希望在第 3 階段進行仔細監測，並產生能夠讓我們對三個階段之間實際潛在差異充滿信心的數字。我們預期這三個分支之間不會有重大差異。

Just to build on both guys points together, Charles. Even in the light of the 2b data, the FDA was still not concerned about the likelihood of [****] Phase 3, they fully understand that this is a core feature of the disease.

查爾斯，只是為了共同鞏固兩個人的觀點。即使根據 2b 數據，FDA 仍然不擔心 [****] 第 3 階段的可能性，他們完全理解這是疾病的核心特徵。

Makes sense, looking forward to that data. A quick question for Steve on HealthPort in terms of that recent collaboration. I guess I'm wondering if you could characterize in any way the current delivery of esketamine or Spravato that HealthPort is involved in? If you can quantify that in any way, so we get a sense of how involved they are in the field?

有道理，期待這些數據。就最近的合作而言，向 HealthPort 的史蒂夫問一個簡單的問題。我想知道您是否可以以某種方式描述 HealthPort 所參與的艾氯胺酮或 Spravato 的當前輸送情況？如果您能以任何方式量化這一點，那麼我們就能了解他們在該領域的參與程度嗎？

Hi Charles, thanks for that question. So first just as a reminder, part of the efforts with creating this network of collaborations is for them to reflect the broad array, the spectrum of where meta healthcare is delivered in this country. Within the existing collaborations, we did not feel there was adequate representation of sites that serve underserved populations, and HealthPort is a very high quality example of a certified community behavioral health clinic that specifically addresses the unmet needs in marginalized and underserved populations.

你好，查爾斯，謝謝你的提問。因此，首先提醒一下，創建這個合作網絡的努力之一就是要反映出這個國家提供元醫療保健的廣泛範圍。在現有的合作中，我們認為為服務不足人群提供服務的站點的代表性不足，而 HealthPort 是一個經過認證的社區行為健康診所的高品質典範，專門解決邊緣化和服務不足人群的未滿足需求。

There are some assumptions that I think are common that community based mental health clinics are not able to deliver newer or more innovative treatments. And it is the fact that HealthPort has been able to deliver Spravato to patients, esketamine, and are highly motivated to make sure that there is not a widening of existing health care disparities and a lack of access for their population if new treatment options are approved.

我認為有一些普遍的假設，即社區心理健康診所無法提供更新或更具創新性的治療。事實是，HealthPort 已經能夠向患者提供 Spravato（艾氯胺酮），並且非常積極地確保，如果新的治療方案獲得批准，現有的醫療保健差距不會擴大，也不會導致患者無法獲得治療。

And so they have some experience already with interventional treatments and are excited about and motivated to be operationally ready to deliver new treatments if approved. And important also to note that inherent within the CCBHC model, certified community behavioral health clinics, is the sharing nationally across that system of best practices and learnings and HealthPort has also historically been a leader there, particularly with disseminating their social determinants and health model.

因此，他們已經在介入治療方面擁有一些經驗，並且對於獲得批准後能夠提供新的治療方法感到興奮和有動力。同樣值得注意的是，CCBHC 模式（認證的社區行為健康診所）的固有特性是在整個系統內共享最佳實踐和經驗，而 HealthPort 也一直處於領先地位，特別是在傳播其社會決定因素和健康模式方面。

Got it. Thank you, Steve.

知道了。謝謝你，史蒂夫。

Your next question comes from the line of Ritu Baral of TD Cowen your line is now open.

您的下一個問題來自 TD Cowen 的 Ritu Baral，您的線路現已開通。

Hi guys, this is Athena on Cowen. Thanks for taking the question.

大家好，我是 Cowen 的 Athena。感謝您回答這個問題。

Given the potential pharma tariffs, can you provide additional color on your manufacturing supply chain and whether there has been any FDA inspection of your manufacturing centers?

考慮到潛在的藥品關稅，您能否提供有關您的製造供應鏈的更多詳細信息，以及您的製造中心是否接受過 FDA 檢查？

Thank you.

謝謝。

Thanks, Athena. So yes, currently, product is manufactured in the UK. We have always planned and are working on plans to add an additional manufacturing capability in the US for commercial supply. So those plans were already underway and we are moving on those. These are sites that have extensive experience of manufacturing, not just for us but our very well established CDMOs for a wide range of pharmaceutical manufacturers, so have had multiple inspections over the years.

謝謝，雅典娜。是的，目前該產品是在英國製造的。我們一直在計劃並正在製定計劃在美國增加額外的製造能力以供商業供應。所以這些計劃已經在進行中，我們正在推動這些計劃。這些工廠擁有豐富的製造經驗，不僅對我們而言，而且對我們為眾多製藥商提供的非常成熟的 CDMO 而言，多年來已經接受過多次檢查。

Do you have a timeline on the additional US site?

您有關於美國附加站點的時間表嗎？

Not at this point. But as I say, we are working on that. That was already in the plan and in our forecast for the next couple of years ahead of potential commercial supply.

目前還不行。但正如我所說，我們正在努力。這已經列入計劃中，並且已經在我們的未來幾年潛在商業供應的預測中。

Yeah, And Athena, it's probably worth mentioning that from a manufacturing perspective, compared to other biotechs or pharmaceuticals, this is a pretty straightforward process and a pretty small quantity of material. And so it's not really at the top of our minds in terms of risks, we're mitigating any risks we have. But as Kabir mentioned, as we near commercialization that is currently the plan.

是的，雅典娜，可能值得一提的是，從製造的角度來看，與其他生物技術或製藥相比，這是一個非常簡單的過程，而且所需的材料量相當少。因此，就風險而言，這並不是我們最關心的問題，我們正在減輕任何風險。但正如卡比爾所提到的，我們已接近商業化，這是目前的計劃。

And clearly, this is a typical small molecule. So in terms since we haven't yet established a price, if, in fact, there was a tariff element on any cost of goods, we would clearly be able to consider that in selling a price in due course.

顯然，這是一種典型的小分子。因此，由於我們尚未確定價格，如果事實上任何商品的成本都包含關稅因素，我們顯然能夠在適當的時候考慮到這一點並製定價格。

Got it, thank you.

知道了，謝謝。

Your next question comes from the line of the Vikram Putohit for Morgan Stanley. Your line is now open.

您的下一個問題來自摩根士丹利的 Vikram Putohit。您的線路現已開通。

Hi guys, thanks for taking our questions. This is Parth for Vikram.

大家好，感謝你們回答我們的問題。這是 Vikram 的 Parth。

Just one question, could you provide the current mix of color, of patients enrolled into comp 005? Like how similar or distinct is the patient profile that was enrolled in the phase 2B?

只有一個問題，您能否提供 005 號公司患者目前的膚色組合情況？例如，參與 2B 期研究的患者概況有何相似或不同之處？

Essentially, the criteria for recruitment are the same. We are not continuously monitoring the actual baseline characteristics. I mean, we're remaining blind to the to the data, but we know that we're recruiting patients using the same criteria, so there's really no reason why there would be any different.

本質上，招募標準是一樣的。我們並沒有持續監測實際的基線特徵。我的意思是，我們對數據仍然一無所知，但我們知道我們使用相同的標準招募患者，所以沒有理由會有任何不同。

The only thing which we have stressed repeatedly in the phase 2B, the actual percentage with prior psychedelic experience was 6%. In the phase 3, it's capped at 15% and while we don't, to Guy's point, know the a exact, we can assume it is around that percentage in the L5 study.

我們在第 2B 階段反覆強調的唯一一件事是，具有迷幻體驗的實際百分比為 6%。在第 3 階段，其上限為 15%，儘管我們不知道 Guy 所指的確切數字，但我們可以假設在 L5 研究中它大約是該百分比。

Okay, thank you. And then just one more quickly. What are your current thoughts on BD specifically with regards to like a large pharma partner, is this something that you guys would be interested in? And if so, when could this make sense?

好的，謝謝。然後再快一點。您目前對 BD 有何看法，特別是關於大型製藥合作夥伴，這是你們感興趣的事情嗎？如果是這樣，什麼時候這才有意義？

Yes, So we are clear that we believe we're doing something unique. And if approved, what we have is paradigm breaking transformational for the treatment of serious mental illness. And our commitment is to do that ourselves in the US if we can, and potentially some other select geographies at the moment. So from our perspective, COMPASS is set up to commercialize COMP360, if approved, and to build from there. And I have no particular comment on big strategic intent at this point.

是的，所以我們很清楚，我們相信我們正在做一些獨特的事情。如果獲得批准，我們將獲得治療嚴重精神疾病的突破性變革。我們的承諾是，如果可以的話，我們將在美國自己做這件事，目前也可能在其他一些選定的地區做。因此，從我們的角度來看，如果獲得批准，COMPASS 將致力於將 COMP360 商業化，並從此開始建造。目前我對重大戰略意圖沒有特別的評論。

All right, thank you.

好的，謝謝。

Your next question comes from the line of a Sumant Kulkarni of Canaccord Genuity. Your line is that will.

您的下一個問題來自 Canaccord Genuity 的 Sumant Kulkarni。你的台詞就是那份意志。

Hi, thanks for taking my question. Also a question on suicidality risk. What do you think is an optimal time to pass before suicidality might not be attributable to a single dose of COMP360? And how much you prepare for imbalances in nonresponders to COMP360 because of the potential unblinding given the nature of the product?

你好，謝謝你回答我的問題。還有一個關於自殺風險的問題。您認為在自殺傾向可能不會歸因於單劑量 COMP360 之前的最佳時間是什麼時候？考慮到產品的性質，您對由於潛在的揭盲而導致的 COMP360 無反應者不平衡做了多少準備？

Thank you, Steven. That's actually quite a tough question. I think my answer is really that we'll look and see what the data shows us, to be honest. I don't think predictions are in order here. That's rather a poor answer to your question, but I think that's the way I feel about it.

謝謝你，史蒂文。這實際上是一個相當棘手的問題。我認為我的答案實際上是，老實說，我們會看看數據向我們展示了什麼。我認為這裡不需要進行預測。這對你的問題來說是一個相當糟糕的回答，但我認為這就是我對此的感受。

Thanks, Just a quick follow-up. Have you seen any changes within the FDA for anyone that might be considered a champion of psychedelic therapeutic approaches in your interaction so far?

謝謝，只是快速跟進一下。到目前為止，在與你的互動中，你是否看到 FDA 內部對可​​能被視為迷幻治療方法擁護者的人做出任何改變？

Thus far, we've seen no changes in our interactions with the FDA, which in the last couple of months have been largely routine around event reporting and so on. Clearly, we're tracking like everyone else, some of the changes higher up in the hierarchy, not only within the FDA but higher up than that. As we've said before, we see that potentially producing some favorable tailwinds for us. But at this stage, nothing has changed around our day-to-day interactions with the agency.

到目前為止，我們與 FDA 的互動沒有發生任何變化，在過去的幾個月裡，我們的互動基本上都是圍繞著事件報告等的例行活動。顯然，我們和其他人一樣，也在追蹤更高層級的一些變化，不僅是 FDA 內部，還包括更高層級的變化。正如我們之前所說，我們認為這可能會為我們帶來一些有利的順風。但現階段，我們與該機構的日常互動並沒有任何改變。

Thank you.

謝謝。

Your next question comes from the line of Patrick Turchi of HC Wainwright. Your line is now open.

您的下一個問題來自 HC Wainwright 的 Patrick Turchi。您的線路現已開通。

Thanks. Good morning.First, just regarding the COMP360 TRD program and the 52 week observational follow-up study. I'm wondering how we should interpret those data in the context of your pivotal program or in the potential commercialization of COMP360 in TRD?

謝謝。早安.首先，關於 COMP360 TRD 計劃和 52 週的觀察性追蹤研究。我想知道我們應該如何在您的關鍵程序背景下或在 TRD 中 COMP360 的潛在商業化背景下解釋這些數據？

And then also in the pivotal TRD program, is there tracking or use of antidepressants or other psychotropic medications post dosing the trials, and how might that inform your durability or safety analyses? And then separately, I'm wondering regarding PTSD, have you initiated regulatory interactions around PTSD program design? And if so, what feedback have you received?

然後同樣在關鍵的 TRD 計劃中，在試驗給藥後是否會追蹤或使用抗憂鬱藥物或其他精神藥物，以及這對您的耐久性或安全性分析有何幫助？另外，我想知道關於 PTSD，您是否啟動了圍繞 PTSD 計劃設計的監管互動？如果是，您收到了什麼回饋？

Steve, do you want to comment first on the durability and how that feeds into how we think about commercialization?

史蒂夫，你想先評論一下耐用性以及它如何影響我們對商業化的看法嗎？

Yeah, I'll start there. Guy may want to jump in with the other part of the question related to the starting of other treatments and the inoperability of the data as we get further into the study. But specifically on durability and to your question about what we learned from that long term extension, I think called 004 and how we will look at durability within the Phase 3 program.

是的，我就從那裡開始。隨著我們進一步深入研究，蓋伊可能想加入問題的另一部分，涉及其他治療的開始以及數據的不可操作性。但具體到耐久性以及您提出的關於我們從長期擴展中學到了什麼的問題，我認為稱為 004，以及我們將如何在第三階段計劃中看待耐久性。

As was mentioned during the opening remarks, there were some limitations as far as the interpretability of the long-term study just because it wasn't the full patient population that continued. However, when looking at all 233 patients from that study included in the primary analysis that did give a very strong signal of durability at least to 12 weeks.

如同開幕詞中所提到的，由於研究對像不是全部患者，因此長期研究的可解釋性存在一些限制。然而，當查看該研究中包含的主要分析的所有 233 名患者時，確實給出了至少長達 12 週的持久性的強烈信號。

And then for those who did continue into the long-term extension study and were followed out to 52 weeks, response up to six months. Now in Phase 3, of course, we'll be reporting initially the six week data. And frankly, durability even to week six in this population, given the limited options available today is already a shift in the paradigm.

然後，對於那些繼續進行長期延長研究並進行 52 週追蹤的人，反應長達六個月。現在，在第三階段，我們當然會先報告六週的數據。坦白說，考慮到目前可用的選擇有限，對於這個群體來說，即使到第六週的持久性已經是一種範式的轉變。

That already would be of tremendous value to patients, to healthcare providers, psychiatrists and others. We will be looking at durability, of course, beyond six weeks, blind it out to week 26 and then we'll have continued opportunity to look at durability in the open label portion probably 26 to week 52. And so we'll have to see what we see there.

這對於患者、醫療保健提供者、精神科醫生和其他人來說已經具有巨大的價值。當然，我們將關註六週後的耐久性，將其盲測到第 26 週，然後我們將繼續有機會關注開放標籤部分的耐久性，大概是第 26 週到第 52 週。所以我們必須看看那裡發生了什麼。

But again, even with the initial data we have, durability up to six weeks would be really groundbreaking in this area

但即使我們只掌握了初步數據，長達六週的耐久性在這一領域也將具有開創性意義

No, So the impact of antidepressants and.....

不，所以抗憂鬱藥物的影響和...

Use of antidepressants and the interpretation of ......

抗憂鬱藥物的使用與解釋.....

I think that the key thing in practice will be that antidepressants are going to be part of the picture for the treatment of these patients. I'm not sure that really it affects -- the key for the patient is to remain well. We're going to see the addition of antidepressant treatments.

我認為實踐中的關鍵是抗憂鬱藥物將成為這些患者治療的一部分。我不確定它是否真的有影響力——對患者來說關鍵是保持健康。我們將會看到抗憂鬱治療的增加。

We can look at that post hoc within the trials. But I think in ordinary practice, we'll expect to see a lot of co-administration. We await obviously proper data on this, but I think you have to anticipate that, that will -- they will pay a part of long-term treatment in these patients.

我們可以在試驗之後再對此進行研究。但我認為在日常實踐中，我們會看到很多共同管理的情況。我們顯然正在等待這方面的適當數據，但我認為你必須預料到，他們將支付這些患者的部分長期治療費用。

And maybe worth saying that it does land a real-world element to the latter portions of these studies, because that is quite common in clinical practice for patients to be on multiple treatments simultaneously, often to continuing antidepressant in the background while they're trying other options.

也許值得一提的是，它確實為這些研究的後半部分提供了現實世界的元素，因為在臨床實踐中，患者同時接受多種治療的情況相當常見，通常在嘗試其他治療方案的同時繼續服用抗憂鬱藥物。

In most cases, the reason why they're trying new treatments is because those background treatments have not been particularly effective. And in some cases, it's just the comfort of being on something. So, as Guy said, the trial is designed for us to particularly in the beginning of the study, differentiate and fully characterize the profile of our drug effect.

大多數情況下，他們嘗試新療法的原因是指那些傳統療法並沒有特別有效。在某些情況下，這只是一種舒適的感覺。因此，正如蓋伊所說，這項試驗的目的是讓我們在研究開始時區分並充分描述我們的藥物效果。

But it is the likelihood that patients will resume some treatments and that will give us an opportunity to better understand what real world practice may look like.

但患者有可能恢復一些治療，這將使我們有機會更了解現實世界的實踐是什麼樣的。

And on PTSD, Patrick, we will be reviewing and discussing those plans with the agency. But as you'll recall, we choose not to give specific feedback on what our discussions are with the agency.

關於創傷後壓力症候群 (PTSD)，帕特里克，我們將與該機構一起審查和討論這些計劃。但您可能還記得，我們​​選擇不就與該機構的討論內容提供具體回饋。

Great thank you so much.

太好了，非常感謝。

Thank you.

謝謝。

That includes our Q&A session. I'd now like to hand back the call to the management.

其中包括我們的問答環節。現在我想把電話交還給管理階層。

Thank you very much. So thanks, everyone, for your time and attention this morning. I think to state the obvious, we are very eagerly awaiting data next month. We know that you are as well. But we remain confident in that data, in that first six week primary endpoint readout of 005.

非常感謝。所以，感謝大家今天上午的時間和關注。我認為顯而易見的是，我們非常熱切地等待下個月的數據。我們知道你也是。但我們仍然對數據充滿信心，前六週的主要終點讀數為 005。

And we continue to make very good progress on recruiting in 006 as well and reconfirm the timelines for that for data in the second half of 2026. So with that, thank you, and we look forward to pressing on and executing and potentially bringing forward a paradigm changing treatment for TRD. Thanks, everyone, and have a good day.

我們在 2006 年的招募工作中也繼續取得了非常好的進展，並再次確認了 2026 年下半年的數據時間表。所以，謝謝您，我們期待繼續努力，執行並可能為 TRD 帶來一種改變範式的治療方法。謝謝大家，祝大家有個愉快的一天。

For attending today's call, you may now disconnect. Goodbye.

為了參加今天的電話會議，您現在可以斷開連線。再見。