Compass Pathways PLC (CMPS) 2026 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Campus Pathways second-quarter 2026 conference call. (Operator Instructions) As a reminder, this call is being recorded.

各位女士、先生，大家好，歡迎參加 Compass Pathways 2026 年第二季財報電話會議。(接線員指示) 提醒各位，本次通話將被錄音。

I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

現在我想介紹今天會議的主持人 Stephen Schultz。您可以開始了。

Thank you, operator. I welcome all of you and thank you for joining us today for this conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. And today I'm joined by Kabir Nath, our Chief Executive Officer; and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available for the Q&A.

謝謝，接線員。歡迎各位，並感謝大家今天加入我們的電話會議。再次自我介紹，我是 Steve Schultz，Compass Pathways 投資人關係資深副總裁。今天與我一同出席的有我們的執行長 Kabir Nath，以及我們的首席商務長 Lori Englebert。我們的財務長 Teri Loxam 也將在問答環節提供協助。

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, we will be making statements about our future plans and prospects that constitute forward-looking statements.

本次通話將被錄音，並將於會議結束後不久在 Compass Pathways 投資人關係網站上提供回放，回放將保留 30 天。在開始之前，提醒各位，今天通話中我們將就未來計畫與前景發表陳述，這些陳述構成前瞻性聲明。

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the US Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change.

每一項前瞻性聲明均受風險與不確定性影響，可能導致實際結果與事件與該等聲明中的預期存在重大差異，包括我們最近向美國證券交易委員會提交文件中「風險因素」標題下所述的風險與不確定性。這些前瞻性聲明僅代表我們截至今日的觀點；即使我們的估計或假設發生變化，我們亦明確聲明不承擔更新或修訂任何前瞻性聲明的義務。

I'll now hand the call to Kabir Nath.

接下來我把電話交給 Kabir Nath。

Thank you, Steve, and thank you all for joining us today. The first half of this year has been an exciting time for Compass. Now that we have highly statistically significant positive Phase 3 primary endpoint readouts as well as demonstrated durability through six months from both our trials, we believe we have largely de-risked the clinical and regulatory profile of COMP360.

謝謝你，Steve，也感謝各位今天加入我們。今年上半年對 Compass 而言令人振奮。現在我們已在兩項試驗中取得具高度統計顯著性的正向第 3 期主要終點讀出，並證實療效可持續至 6 個月，我們相信 COMP360 的臨床與監管概況已在很大程度上完成去風險化。

In addition to confirming its rapid onset and durability, the totality of data from the program so far shows it has a generally well-tolerated and safe profile. Taken together, these data reinforce our belief that COMP360 has the potential to fundamentally change how mental health is managed.

除了確認其起效迅速與持久性之外，迄今為止該計畫的整體數據顯示其整體耐受性良好且安全性概況良好。綜合而言，這些數據進一步強化我們的信念：COMP360 有潛力從根本上改變心理健康的管理方式。

With these data sets in hand, we continue to make significant progress towards our NDA filing for the treatment of TRD. Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we've already submitted. We continue to expect to complete the NDA filing in the fourth quarter.

在掌握這些數據集後，我們持續朝向針對 TRD 治療的 NDA 申請提交取得重大進展。我們的滾動式提交與審查流程使我們能分批向 FDA 提交數據，而他們已開始審查我們先前提交的部分模組。我們仍預期在第四季完成 NDA 申請提交。

With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness. We built a fantastic commercial team with incredible experience, and we're executing on all fronts to be prepared to get COMP360 to the millions of patients living with CRD who urgently need new treatment options. We're also well-positioned with our strong balance sheet with $433 million of cash on hand as of June 30, which carries us well through launch and into 2028.

鑑於在最終提交後可能獲得加速核准，我們正推進商業化就緒準備。我們建立了一支卓越的商業團隊，具備令人驚豔的經驗；我們正全方位執行，為將 COMP360 帶給數以百萬計、迫切需要新治療選項的 CRD 患者做好準備。截至 6 月 30 日，我們亦憑藉強健的資產負債表處於有利位置，手上現金為 4.33 億美元，可支持我們順利度過上市並延續至 2028 年。

Let me now hand the call to Lori to talk through in more detail how we're preparing to transform treatment options for these patients.

接下來我把電話交給 Lori，請她更詳細說明我們如何準備為這些患者帶來治療選項的轉型。

Thanks, Kabir. Hi, everyone. Thank you for joining. As Kabir outlined, we have achieved significant milestones in the first half of the year. Notably, advanced important commercial readiness initiatives across organizational capabilities, strategic collaboration, policy and payer engagement, and distribution, all significant steps towards being launch ready.

謝謝你，Kabir。各位好。感謝各位參與。如 Kabir 所述，我們在今年上半年達成了重要里程碑。尤其是，我們在組織能力、策略合作、政策與支付方互動，以及配送等面向推進了重要的商業化就緒計畫，這些都是邁向上市就緒的重大步驟。

Earlier this year, we rounded out hiring of the commercial leadership team, attracting highly experienced energized leaders who immediately started to build out their functions. My direct reports come from companies like J&J, Gilead, Otsuka, and Axsome and between them have led over 70 product launches.

今年稍早，我們完成了商業領導團隊的招募，吸引到經驗豐富且充滿活力的領導者，他們立即開始建立各自的職能團隊。我的直屬部屬來自 J&J、Gilead、Otsuka 與 Axsome 等公司，他們合計主導過超過 70 次產品上市。

The prospect of launching the first psychedelic in history with a medicine that has the potential to fundamentally change the way mental health is treated is a very powerful attractor of talent, and we are bringing in outstanding professionals from across the pharma industry. I am incredibly proud of the team we are building at Compass.

推出史上第一款迷幻藥物，且該藥物有潛力從根本上改變心理健康治療方式，這樣的前景對人才具有強大吸引力；我們正從整個製藥產業延攬傑出專業人士。我對我們在 Compass 正在打造的團隊感到無比自豪。

In the first half of this year, we also announced additional strategic collaborations with Radial and Osmind, taking the total to eight, each with their own distinct capabilities. These collaborations played a critical role in helping to inform our priority focus at launch of ensuring optimal site and patient experience.

在今年上半年，我們也宣布與 Radial 與 Osmind 展開額外的策略合作，使合作總數達到八項，每一項皆具備其獨特能力。這些合作在協助我們釐清上市時的優先重點方面扮演關鍵角色，也就是確保最佳的據點與患者體驗。

With the final submission of our NDA expected in the fourth quarter, our focus in the second half of this year is on operationalizing launch plans and ensuring launch readiness. This includes advancing everything from training, education, access and reimbursement, and patient support mechanisms.

隨著我們預期在第四季完成 NDA 的最終提交，我們今年下半年的重點在於將上市計畫落地執行並確保上市就緒。這包括推進從訓練、教育、可近性與給付/報銷，到患者支持機制等各項工作。

Importantly, we have also already initiated recruiting for the sales force. Our timeline for launch remains fluid, given the national priority review voucher and executive order in April, and the need for DEA, federal DEA, and state rescheduling. We remain focused on being ready to launch, which we anticipate being in the first half of 2027.

重要的是，我們也已開始招募銷售團隊。由於 4 月的國家優先審查憑證與行政命令，以及需要 DEA（聯邦 DEA）與各州進行重新分級（rescheduling），我們的上市時間表仍具彈性。我們仍專注於做好上市準備，並預期將於 2027 年上半年上市。

At launch, we will leverage the well-established existing interventional psychiatry treatment center infrastructure. These treatment sites are specifically designed to support in-office treatment for products that require multi-hour monitoring, such as Spravato, TMS, and ECT. The established infrastructure has existing capacity and, importantly, is already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360.

上市時，我們將運用既有且成熟的介入式精神醫學治療中心基礎設施。這些治療據點專為支援需在診所內治療、且需要數小時監測的產品而設計，例如 Spravato、TMS 與 ECT。這套既有基礎設施具備現有產能，更重要的是，已配備支援如 COMP360 這類額外數小時療程所需的人員與營運專業能力。

Seven years ago, when Spravato launched, this infrastructure did not exist. Today, there are more than 8,000 established sites across the US, and this continues to grow rapidly. COMP360 is poised to lead a profound shift in mental health care, moving beyond daily or frequent dosing toward an option potentially involving just a few treatments a year, which could be life-changing for patients.

七年前 Spravato 上市時，這樣的基礎設施尚不存在。如今，美國已有超過 8,000 個成熟據點，且仍在快速成長。COMP360 有望引領心理健康照護的深刻轉變，從每日或頻繁給藥，轉向可能一年僅需少數幾次治療的選項，這對患者而言可能改變人生。

Across two highly statistically significant and positive Phase 3 trials, COMP360 demonstrated extremely rapid onset of action with deep and clinically meaningful reduction in depressive symptoms as quickly as one day, unprecedented durability sustained through at least six months, and notably, reproducibility of effect in a chronic treatment-resistant patient population, one of the most difficult psychiatric conditions in which to demonstrate efficacy.

在兩項具高度統計顯著性且結果正向的第 3 期試驗中，COMP360 展現極快速的起效時間，最快一天即可在憂鬱症狀上達到深度且具臨床意義的降低；並呈現前所未見的持久性，至少可維持至 6 個月；此外，值得注意的是，在慢性且治療抗拒的患者族群中，其效果具可重現性——這是最難證明療效的精神疾病狀況之一。

The data are strong, and both patients and prescribers are excited about the potential for a new treatment option. In recent prescriber-focused market research, approximately 90% of interventional psychiatrists stated that they would prescribe COMP360 within the first year of being available. In my experience, this is the highest willingness to prescribe percentage I have ever seen in prelaunch market research.

數據相當強勁，患者與開立處方者都對新的治療選項潛力感到振奮。在近期以處方醫師為對象的市場研究中，約 90% 的介入式精神科醫師表示，在 COMP360 上市後的第一年內會開立處方。以我的經驗而言，這是我在上市前市場研究中見過最高的處方意願比例。

With the COMP360 emerging profile and continued interest and excitement around the class, we are eager to bring a new treatment option to the 4 million patients living with TRD today who have limited treatment options, and we are confident in the blockbuster opportunity.

隨著 COMP360 的新興特性逐步明朗，且市場對此類別持續抱持高度興趣與期待，我們渴望為目前約 400 萬名、治療選項有限的 TRD 患者帶來一項新的治療選擇，並且我們對其成為重磅產品的機會充滿信心。

COMP360 has the potential to fundamentally change the way that patients living with depression are cared for, and Compass is committed to helping as many patients as possible. We are making significant progress towards being launch ready and I look forward to discussing more with you throughout the rest of this very exciting year.

COMP360 有潛力從根本上改變憂鬱症患者的照護方式，而 Compass 致力於協助盡可能多的患者。我們在達成上市準備方面正取得重大進展，我也期待在接下來這個令人振奮的一年裡，持續與各位分享更多進展。

Thank you and let me hand the call back to Kabir.

謝謝，接下來我把電話交回給 Kabir。

Thank you, Lori. Our progress in the first half of the year has meaningfully de-risked the path towards potential approval and launch and reinforces our confidence in the strength, consistency, and robustness of the COMP360 data package that we are submitting to the FDA.

謝謝你，Lori。我們在今年上半年取得的進展，已實質降低了邁向潛在核准與上市的風險，並進一步強化我們對提交給 FDA 的 COMP360 數據資料包之強度、一致性與穩健性的信心。

With the regulatory process underway, our focus is on disciplined execution, completing our filing activities and preparing for a first-pass approval and ensuring we are poised to deliver COMP360 to patients with TRD as quickly as possible following approval. And as you just heard from Lori, we will be ready.

在法規審查流程已啟動的情況下，我們的重點是有紀律地執行：完成申報相關工作、為一次性通過核准做好準備，並確保在核准後能以最快速度將 COMP360 提供給 TRD 患者。正如各位剛才從 Lori 聽到的，我們將會準備就緒。

With that, let me pass the call to the operator for Q&A. Thank you.

接下來，我把電話交給接線員進行問答。謝謝。

(Operator Intructions) Paul Matteis, Stifel.

(接線員指示) Paul Matteis，Stifel。

Hey, good morning. Thanks so much for taking my question. Specifically, I was wondering if the team could offer some perspective on the recently issued FDA guidelines around psychedelics. And more specifically, how did you interpret the discussion of those guidelines as it relates to 12-month blinded durability? What do you think that really means or what the FDA is asking for? And how do we think about that in the context of the COMP360 program? Thanks so much.

嗨，早安。非常感謝讓我提問。我想請團隊就近期 FDA 針對迷幻藥物（psychedelics）發布的指引，提供一些看法。更具體地說，你們如何解讀該指引中與「12 個月盲態持久性（blinded durability）」相關的討論？你們認為那實際上代表什麼，或 FDA 想要的是什麼？以及在 COMP360 計畫的脈絡下，我們應該如何看待這件事？非常感謝。

Thanks, Paul. I'm just checking you can hear me clearly here.

謝謝你，Paul。我先確認一下，你現在聽得到我說話清楚嗎？

Yes, thank you.

是的，謝謝。

All right, thanks. Yes, so, look, I think as you're aware, this is a finalization of a set of draft guidelines. And the original draft in fact came out even after we had fully designed our Phase 3 aligned with the agency on that and so on.

好的，謝謝。是的，你也知道，這是先前一套指引草案的最終定稿版本。而最初的草案其實是在我們已經完成第三期試驗設計、並且與主管機關就設計達成一致之後才發布的。

So our perspective is we have had very robust continuing dialogue with the agency throughout this program. And while the guidance is certainly interesting and we do have thoughts on the 12 months blinded and that would seem like a pretty tall order for any psychiatry drug, we actually don't think it's going to impact the process of our regulatory approval at this stage.

因此我們的看法是：在整個計畫期間，我們一直與主管機關保持非常充分且持續的溝通。雖然該指引確實值得關注，我們對「12 個月盲態」也有一些想法——對任何精神科藥物而言，這看起來都是相當高的要求——但我們其實不認為它會在此階段影響我們的法規核准流程。

I think the other parts of that that I draw your attention to is the design of Phase 3 studies in a complementary pair continues to be effectively exactly in line with the design of our studies. So while I think the guidance is interesting, and obviously in terms of future endeavors, we will be carefully looking at that. We honestly do not think that these guidelines are going to impact the regulatory process that's already underway for us.

我也想提醒你注意其中另一部分：第三期研究以互補的一對試驗來設計，這一點基本上與我們研究的設計完全一致。所以我認為該指引很有意思，當然就未來的工作而言，我們會仔細研讀。但我們坦白說，不認為這些指引會影響我們目前已在進行中的法規流程。

Great, thanks so much.

很好，非常感謝。

Francois Brisebois, LifeSci Capital.

Francois Brisebois，LifeSci Capital。

Hi, thanks for the question here. I was just wondering, in terms of launch, can you help us understand -- this always happens, especially in your situation, just the reimbursement challenges. What are we going to have to go through just to get a better feel for the cadence here with the launch expected next year?

嗨，謝謝讓我提問。我想了解一下，就上市而言，你們能否協助我們理解——這種情況很常見，尤其在你們這種情境下——也就是給付（reimbursement）方面的挑戰。為了更掌握明年預期上市的節奏，我們大概需要經歷哪些流程？

Hey, Frank. Thanks for the question. As you mentioned, launches are traditionally hard coming out of the gate with reimbursement just because you need time. What we are doing now is our market access team is already engaging with payers, and they have been now for some time.

嗨，Frank。謝謝你的問題。如你所說，新產品上市初期在給付方面通常都比較困難，主要是因為需要時間。我們目前正在做的是：市場准入團隊已經在與付款方（payers）接觸，而且已經進行了一段時間。

We're getting very positive feedback from the payers, especially in this TRD patient population, where proving efficacy has almost been impossible to do in the past. So it is playing very well with a key stakeholder who really, truly understands the economic burden that patients with TRD can have on a payer system.

我們從付款方那裡得到非常正面的回饋，特別是在 TRD 這個患者族群中，過去幾乎不可能證明療效。因此，這對於真正理解 TRD 患者可能對付款方體系造成之經濟負擔的關鍵利害關係人而言，反應非常好。

So at launch, what we expect is we are intending to have a field reimbursement team fully deployed at the time of launch who will be out helping these sites ensure that they can code and get the reimbursement that they need to code for and making sure that they're well-educated in the process.

因此在上市時，我們預期會在上市當下就完整部署一支外勤給付支援團隊，前往各治療據點協助其確保能正確編碼（coding）並取得所需的給付，同時確保他們充分了解整個流程。

In terms of the drug reimbursement and the conversations we're having with payers right now, we are working through that. We are still adjusting the data that we just got and released a couple weeks ago into the value proposition that COMP360 can bring, and then we'll make decisions as we get closer to launch on what that might look like in terms of rebating and payer negotiations for formulary access.

至於藥品給付本身，以及我們目前與付款方進行的對話，我們正在逐步推進。我們仍在把幾週前剛取得並公布的數據，納入 COMP360 可帶來的價值主張中進行調整；接著在更接近上市時，我們會就可能的回扣（rebating）以及與付款方就納入處方集（formulary access）的談判，做出相應決策。

Gavin Clark-Gartner, Evercore.

Gavin Clark-Gartner，Evercore。

Hey, guys. Congrats on the progress. Thanks for taking the question. Maybe you could just characterize how any ongoing regulatory discussions are progressing? And separately, what are your expectations for DEA scheduling timelines at this point? Thank you.

嗨，各位。恭喜進展順利。謝謝回答問題。你們能否概述一下目前仍在進行的法規討論進展如何？另外，就目前而言，你們對 DEA 排程（scheduling）時程的預期是什麼？謝謝。

Thanks, Gavin. So on the first part, I would just say they're going well. I mean, the rolling submission is well underway. As I noted in the remarks, some of what has been sent is under review. We're getting questions on it. Clearly, given the acceleration, given the NPV, the onus is also on us to respond very quickly, and we're doing that. So the team is doing an amazing job of being responsive to that.

謝謝你，Gavin。第一部分我會說進展良好。也就是說，滾動式提交（rolling submission）正在順利進行。如我在致詞中提到的，我們已提交的部分內容正在審查中。我們也收到一些問題。顯然，考量到加速審查、以及 NPV（非公開資訊）相關要求，我們也有責任非常快速地回覆，而我們正在這麼做。因此團隊在回應方面做得非常出色。

Nothing out of the ordinary that I would say. We remain on track. And as you know, it's only one kind of in the later stages that things like label and REMS really come into play. Those are typically negotiated fairly late in the day. So nothing, really nothing untoward to report except we're very happy with progress. On rescheduling. I'll hand to Lori.

我認為沒有任何不尋常之處。我們仍按計畫推進。而且如你所知，通常要到後期階段，像是標籤（label）與 REMS 才會真正成為重點。這些通常是在相當後期才進行協商。所以沒有什麼不妥之處可報告，只是我們對進展非常滿意。至於重新排程（rescheduling）。我把問題交給 Lori。

Yes, hi, Gavin. We are accelerating our eight-factor analysis, getting that to the CSF, FDA Division of Controlled Substance, as quickly as possible, and in hopes of that enabling a faster FDA and DEA coordination along the way. We are also heavily engaging with the DEA or attempting to engage with the DEA to help see if we can get any further clarity on what that looks like.

是的，嗨，Gavin。我們正在加速完成八因素分析，並儘快提交給 CSF（受管制物質職能部門，FDA 受管制物質處）。我們希望這能在過程中促成 FDA 與 DEA 更快速的協調。我們也正積極與 DEA 接洽，或嘗試與 DEA 接洽，以看看能否就其具體樣貌取得更進一步的釐清。

As I've mentioned in the past, the DEA is pretty consistent in hitting their 90 days. So we feel very confident that they will reschedule within the 90 days, but it's still a little bit fluid in terms of when that actually will happen. But given the executive order in April, we are confident in the ability to potentially pull that forward.

如我過去提過的，DEA 在達成其 90 天時程方面一向相當一致。因此我們非常有信心他們會在 90 天內完成重新排程（reschedule），但實際何時發生在時間點上仍有些變動。不過，鑑於四月的行政命令，我們對於有機會將時程提前的能力抱持信心。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Good morning, guys. Thanks for taking the question. Another question for you, Lori, specifically around the term training that you used in the prepared remarks. It sounds like in response to some of the prior questions, some of that training for the interventional psychiatry sites will revolve around coding. But I wanted to ask what other aspects of training does the team plan on offering interventional psychiatry sites, especially given that you have a good -- a very solid precedent REMS to sort of train against and anticipate?

各位早安。謝謝讓我提問。我還有一個問題想請教你，Lori，特別是關於你在事先準備的講稿中使用的「訓練」一詞。聽起來，回應前面一些問題時，你提到針對介入式精神醫學（interventional psychiatry）據點的部分訓練會圍繞在編碼（coding）。但我想問的是，團隊計畫為介入式精神醫學據點提供訓練的其他面向有哪些？尤其是你們已有一個很好的——非常扎實的——REMS 先例可作為訓練依據並加以預期？

How do you anticipate offering sort of readiness services to those sites, and how does that impact I think how all of us may model 2027 rollout? Here at TD Cowen, we've had experience with sponsors really wanting to manage the early experience with a drug at sites and with clinicians on early rollout. So anything you can tell us about sort of the general shape of 2027 as you see it now with the training offered? Thanks.

你們預期會如何向這些據點提供所謂的就緒（readiness）服務？這又會如何影響我們大家對 2027 年推廣（rollout）的建模？在 TD Cowen，我們曾看到贊助商在早期推廣時，確實希望在據點與臨床醫師端管理藥物的早期使用經驗。因此，關於你們目前所看到的 2027 年整體輪廓，以及所提供的訓練，你能分享的任何資訊都很有幫助。謝謝。

Yes, hey, Ritu, thanks for the question. I'm going to try and collect it all into one cohesive thought. So the way I think about training -- you're brilliant at this, you know. We think about training in two parts. So there's going to be training and there's going to be education. So I will address both.

好的，嗨，Ritu，謝謝你的問題。我會試著把這些整合成一個連貫的想法。所以我對「訓練」的看法——你在這方面很厲害，你知道的。我們把訓練分成兩個部分來看。會有訓練（training），也會有教育（education）。所以我會兩者都回應。

But in terms of training and specifically training, we announced a little while ago that we are participating in grants for third-party companies to help with the training of the site, both on psychedelics and as soon as COMP360 gets a final label on anything that's required for the monitoring time that the patient will be in the room.

就訓練而言，特別是訓練本身，我們不久前宣布我們正參與提供補助（grants），由第三方公司協助據點訓練，涵蓋迷幻藥（psychedelics）相關內容；並且一旦 COMP360 取得最終標籤（final label），也會針對任何與監測時間要求相關、病患需在房間內停留的時間進行訓練。

We want to make sure that that patient experience is a very good one. And so we're still doing that. So the sites will need to be trained because in the REMs, they will need to attest to being trained. And part of that will be based on the training that these third-party providers are enabling. Already, there are well over 1,000 people who are already trained on the psychedelic portion of that training. And so there is a broad group of people already ready to go with that training.

我們希望確保病患體驗非常良好。因此我們仍在持續推進這件事。據點將需要接受訓練，因為在 REMS 中，他們需要證明（attest）自己已受過訓練。其中一部分將以這些第三方供應商所提供的訓練為基礎。目前已經有遠超過 1,000 人完成了該訓練中的迷幻藥部分。因此，已經有一大群人具備該訓練、隨時可以上線。

The other training, again, the COMP360 piece of that particular training on how to best support a patient and help enable a very good patient experience, that will come after we see the final label and we get that finalized. We also will need to do training on REMS to make sure that they are compliant with REMS certification and all the things that they need to do with REMS.

另一部分的訓練，同樣地，針對該訓練中的 COMP360 內容——也就是如何以最佳方式支持病患並促成非常良好的病患體驗——將會在我們看到最終標籤並完成定稿之後才會推出。我們也需要就 REMS 進行訓練，以確保他們符合 REMS 認證（certification）以及所有在 REMS 下需要做的事項。

So in terms of rollout, in some cases, the fact that there will likely be a little bit of time between when we get approval and when the DEA will reschedule and then the states will reschedule, obviously, we're trying to do this as fast as possible. We are going to leverage that time to the best of our ability. And so we will have teams out immediately upon approval, helping these sites make sure that they know the requirements that will be under the REMS.

因此就推廣而言，在某些情況下，從我們取得核准到 DEA 完成重新排程、再到各州完成重新排程之間，可能會有一段時間；當然，我們正盡可能加快速度。我們會盡最大能力善用這段時間。因此，一旦獲得核准，我們會立刻派出團隊到現場，協助這些據點確保他們了解 REMS 之下的各項要求。

And as we learn a little bit more and get closer, will be able to start communicating what we expect in terms of site readiness. This will be, obviously, a key KPI that we will want to communicate on, and then, obviously, when it comes time to prescribing. As we are thinking through this, obviously, and you mentioned it before, which means you've listened to me in the past, and the importance of making sure that the site and the patients have a very good experience. We are very acutely aware that we are leading the way here, and it is important for us to maintain that leadership.

隨著我們了解更多並逐步接近，我們也將能開始溝通我們對據點就緒度（site readiness）的預期。這顯然會是一個我們希望對外溝通的關鍵 KPI，然後當然也包括進入開立處方（prescribing）的階段。在我們思考這些時——而你先前也提到過，表示你過去有聽我說——確保據點與病患有非常良好的體驗非常重要。我們非常清楚我們正在引領這條路，因此維持這份領導地位對我們很重要。

And so the other piece that I do want to just quickly touch on is there will also be patients. This is our field force educating the prescribers, the referring physicians. This is our medical science liaisons who have been out in the field for 2.5 now, continuing to educate there. And we're going to continue to do additional support things like peer-to-peer education and enabling that in an outsized way just to make sure that we are covering all the bases and everyone is very much aware of the potential of COMP360.

另外我也想很快補充的一點是，也會有病患相關的部分。這是我們的外勤團隊在教育開立處方者（prescribers）與轉介醫師（referring physicians）。這也是我們的醫學科學聯絡人（MSLs）在外勤已經跑了 2.5 年，並持續在現場進行教育。我們也會持續提供額外的支持，例如同儕對同儕（peer-to-peer）的教育，並以更大力度推動，以確保我們涵蓋所有面向，讓每個人都充分了解 COMP360 的潛力。

Andrew Tsai, Jefferies.

Andrew Tsai，Jefferies。

Hey, good morning. Thanks for the updates. Appreciate you taking the questions. So I think you guys are in a very unique position to be the leader in the psychedelic space. So to maintain that leadership over the next year, what is your appetite like to do even more studies with COMP360 outside of PTSD and so forth? And any new indications or other new psychedelics we can hear about, or is the expectation for us to be focused on the launch itself? Thank you.

嗨，早安。謝謝更新。也感謝你們回答問題。我認為你們在迷幻藥領域處於非常獨特的位置，有機會成為領導者。因此，為了在未來一年維持這個領導地位，你們對於在 PTSD 等適應症之外，使用 COMP360 進行更多研究的意願如何？是否有任何新的適應症或其他新的迷幻藥項目可以分享？或者我們應該預期把重點放在上市（launch）本身？謝謝。

Thank you for the question, Andrew. So yes, the expectation should be to be focused on the launch at least for now. Clearly as a new company with our first asset, we have a team that's incredibly working incredibly hard on the submission. But more than that, as I said in the prepared remarks, on a first-pass approval, because submitting is something that this needs to be a really robust dossier.

謝謝你的問題，Andrew。所以是的，至少就目前而言，大家的預期應該是聚焦在上市。很明顯地，作為一家新公司、且這是我們的第一個資產，我們的團隊正非常努力地推進申報（submission）。但不僅如此，正如我在事先準備的講稿中所說，若要一次就通過核准（first-pass approval），因為申報這件事需要一份非常扎實的資料檔案（dossier）。

We are the leaders, you can imagine, from a quality perspective, from inspections and so on. All of this is brand new to the agency. So we really are very, very focused on not only a really robust submission, but also doing our best to get that first-pass approval. You've heard a lot from Lori, and we'll continue to hear a lot more about the preparations and so on, on that side.

我們是領導者——你可以想像——在品質面、在稽查（inspections）等方面。這一切對主管機關而言都是全新的。因此我們確實非常、非常專注於不僅要提交一份非常扎實的申報資料，也要盡最大努力達成一次就通過核准。你已經從 Lori 那裡聽到很多內容，之後也會繼續聽到更多關於準備工作等方面的資訊。

The PTSD study is now underway. I think the way we think about this is, as we move through what we hope is an expected approval and launch, absolutely we will continue to look at other opportunities for COMP360. There are clearly some very interesting areas. There is a lot of interest, obviously, in substance use disorder with AUD in particular at the forefront of that, given the size of that as a public health issue. And potentially more broadly, what other assets that may be out there as well. But in the short term, you should expect us to be very, very focused on this submission, approval, and launch process for TRD.

PTSD 研究目前正在進行中。我認為我們看待這件事的方式是，隨著我們推進我們希望能如期獲得核准並上市的進程，我們絕對會持續尋找 COMP360 的其他機會。顯然有一些非常有趣的領域。大家對物質使用障礙（SUD）顯然很有興趣，尤其是酒精使用障礙（AUD）更是焦點，考量到其作為公共衛生議題的規模。以及可能更廣泛地，市場上也可能還有其他資產。但短期內，你們應該預期我們會非常、非常專注於 TRD 的遞交申請、核准與上市流程。

And Andrew, if you don't mind, I'll just add a couple things there to help add a little more color. So consistent with what Kabir mentioned, we have supplied study drugs to an enormous amount of IIS studies, and so we will be looking through those to understand where the potentials may lie if that becomes an option for us with COMP360.

Andrew，如果你不介意，我再補充幾點，讓內容更具體一些。因此，與 Kabir 提到的一致，我們已向大量 IIS 研究提供試驗用藥，因此我們會檢視這些研究，以了解若 COMP360 對我們而言成為一個選項，潛在機會可能在哪裡。

And at the same time, we're also going to be collecting a lot of real-world evidence to really understand more about patient populations that may be responding well to COMP360. We will be attacking this on all fronts in terms of understanding what would be the next viable indication.

同時，我們也會蒐集大量真實世界證據（RWE），以更深入了解哪些病人族群可能對 COMP360 反應良好。在理解下一個可行適應症方面，我們會從各個面向同步推進。

Actually, yes, just, sorry, I should have said that, Lori, to build on that. We had taken a pause for a couple of years on our IIS. As we said, we have supplied a lot of drug for a number of indications. We are now ramping that up again. So we actually have a number of IISs starting in areas such as OCD, which I think is potentially a very interesting area. So that now, as we're getting closer to the regulatory finish line for TRD, we're actually restarting our IIS programs.

其實是的，抱歉，我應該先說這點，Lori，接著你的話補充。我們的 IIS 曾暫停了幾年。如我們所說，我們已為多個適應症提供了大量藥物。我們現在正再次加速推進。因此，我們確實有多項 IIS 正在啟動，例如在 OCD 等領域，我認為那可能是一個非常有趣的方向。所以，隨著我們更接近 TRD 的法規終點線，我們其實正在重新啟動 IIS 計畫。

Great. Thank you.

很好。謝謝。

Madison El-Saadi, B. Riley.

Madison El-Saadi，B. Riley。

Hi, everyone. Thanks for taking our question. Maybe I'll ask on RIM certification, if you could just kind of help us understand that process, if this is something that's molecule-specific? And can sites proactively progress that process before DEA rescheduling takes place, or is that something that happens sequentially? And secondly, if I may, are you continuing to collect safety data or safety follow-up data, or has the full safety data package been submitted? Thanks.

嗨，各位。謝謝你們回答我們的問題。我想先問 REMS 認證（certification），能否請你們協助我們理解該流程，這是否是針對特定分子（molecule-specific）的？另外，在 DEA 重新分級（rescheduling）發生之前，各中心（sites）是否可以主動推進該流程，還是必須按順序逐步進行？第二個問題，如果可以的話，你們是否仍在持續蒐集安全性資料或安全性追蹤資料，或是完整的安全性資料套件已經提交？謝謝。

So I'll take the second part first and hand back to Lori. So both studies run to 52 weeks. So we will ultimately be providing the full 52-week safety data to the agency. Right now, obviously, with the 26-week data from 006 in hand, our core focus now in terms of preparing for submission is really integrating the safety from the 26 weeks blinded of both studies into an integrated summary. And that's clearly a key area of focus for us. But ultimately, the agency in the process of review will see the 52 weeks of data as well.

我先回答第二部分，然後再交給 Lori。兩項研究都會進行到 52 週。因此，我們最終會向主管機關提供完整的 52 週安全性資料。目前，顯然我們已取得 006 試驗的 26 週資料，就遞交申請準備而言，我們現在的核心重點是把兩項研究在 26 週盲態（blinded）的安全性資料整合成一份整合性摘要。這顯然是我們的重點工作之一。但最終，在審查過程中，主管機關也會看到 52 週的資料。

Yes, hi, Madison. I'll take your first question around REMS. So as you know, the REMS will not be finalized until we receive approval. And so because of that, we will only be able to go out and start ensuring that sites are aware of any REMS requirements and going through the process for certification once we receive the approval.

是的，嗨 Madison。我來回答你第一個關於 REMS 的問題。如你所知，在我們獲得核准之前，REMS 不會定案。因此，基於這點，我們只能在獲得核准後，才會開始對外溝通並確保各中心了解任何 REMS 要求，並啟動認證流程。

And as I mentioned earlier, as it stands now, we're going to do everything we possibly can in between the time of approval and DEA rescheduling to make sure that these sites are well-prepared to administer the product when it becomes available.

而且如我先前提到的，就目前而言，我們會在核准與 DEA 重新分級之間的這段時間，盡一切可能確保這些中心做好充分準備，以便產品一旦可用就能施用。

Understood. Thanks for taking our question.

了解。謝謝你們回答我們的問題。

Judah Frommer, MS.

Judah Frommer，MS。

Yes, hi guys, thanks for taking the question. Just wanted to ask on the post-hoc analysis you mentioned in the release on the 80% of administration sessions for the 2b and PTSD being in silence. Any thoughts on how that could impact monitoring, whether it's for TRD or PTSD, and potentially staffing requirements going forward? Thanks.

是的，嗨各位，謝謝回答問題。我想問一下你們在新聞稿中提到的事後分析（post-hoc analysis）：在 2b 與 PTSD 的給藥（administration）療程中，有 80% 的時間是在安靜（silence）狀態。你們認為這可能如何影響監測方式（monitoring），不論是 TRD 或 PTSD，以及未來可能的人力配置需求？謝謝。

Let me start, and then Lori will build on that. So yes, I think to us, it's very interesting data and really very much validates the point we've been making for a fair amount of time now, that a psilocybin experience, specifically, truly is an inner-directed one where the patient is largely leading the experience.

我先說，然後 Lori 再補充。是的，我認為對我們而言，這是非常有趣的資料，也在很大程度上驗證了我們一段時間以來一直在強調的觀點：特別是裸蓋菇素（psilocybin）的體驗，確實是一種內在導向（inner-directed）的體驗，病人在很大程度上主導整個過程。

And the role of anyone who is sitting with a patient is just for monitoring and for safety in case of need. And we see that very clearly revealed, as we said, with 80% of that being being silent. And yes, to your point, that clearly, to our mind, does introduce a broader range of possibilities for who could sit in the room, if indeed, ultimately, you need somebody in the room at all.

而陪同病人的人，其角色只是為了監測與安全，以備不時之需。我們非常清楚地看到這點被揭示出來，正如我們所說，其中 80% 的時間是安靜的。而且是的，如你所說，這在我們看來，確實引入了更廣泛的可能性：究竟由誰坐在房間裡陪同；甚至最終是否真的需要有人在房間裡。

I agree. And hi, Judith. The only thing I'll add there is in the near term, in terms of when we receive the REMS, there will be a requirement for minimum six hours. That is consistent with our clinical trials. And the label or the REMS requirement for who sits in the room will and should be, or we expect to be fairly broad in terms of a healthcare provider. And that is consistent with what Spravato is now.

我同意。嗨，Judith。我在這裡唯一要補充的是，短期內，就我們收到 REMS 後而言，將會有至少六小時的要求。這與我們的臨床試驗一致。而標籤（label）或 REMS 對於「誰坐在房間裡」的要求，將會、也應該會（或我們預期會）相當寬泛，以醫療照護提供者（healthcare provider）的範疇來界定。這也與 Spravato 目前的做法一致。

And as you probably already know, Spravato has found ways to become very efficient with their rooms and how they monitor. Of course, our most important, requirement is going to be safety for the patient during this experience. And so we will not lose sight of that. But sites, after getting clinical experience, will learn how and who to put into the room to help these patients.

而且你可能已經知道，Spravato 已經找到方法，讓他們的房間使用與監測方式變得非常有效率。當然，我們最重要的要求將會是確保病人在這段體驗期間的安全。因此，我們不會忽視這一點。但各中心在累積臨床經驗後，會學會如何安排、以及由誰進入房間來協助這些病人。

Patrick Trucchio, H.C. Wainwright.

Patrick Trucchio，H.C. Wainwright。

Hi, it's Arabella on for Patrick. Thank you so much for taking the question. I guess for the PTSD trial, do you have any updates on site activation, enrollment cadence, target size, expected readout timing, or VA involvement that you can share?

嗨，我是代 Patrick 提問的 Arabella。非常感謝你們回答問題。我想請問，關於 PTSD 試驗，你們是否能分享任何最新進展，例如中心啟動（site activation）、收案速度（enrollment cadence）、目標樣本數（target size）、預期讀出（readout）時間點，或 VA 參與情況？

So other than the site is underway, nothing in terms of enrollment and so on. The trial is 300 patients in total across three arms. There are going to be a number of VA sites enrolled in that. I can't give the specifics on that. What we are doing, though, is in line with the overall percentage of PTSD patients within the population, where, shall we say, VA or military-related are not more than 15%. We're capping patient numbers, again, about out of the 300. But yes, it is underway. And yes, it's a 300-patient trial.

因此，除了該試驗中心正在啟動之外，在受試者入組等方面目前沒有其他可更新的內容。這項試驗總計 300 名患者，分為三個治療組別。其中將會有多個 VA（退伍軍人事務部）站點參與入組。我無法提供具體細節。不過，我們的做法是符合整體族群中 PTSD 患者的比例；也就是說，VA 或軍方相關患者的比例不會超過 15%。我們會對患者人數設上限，同樣地，是在這 300 名之中。但沒錯，試驗正在進行中。而且沒錯，這是一項 300 名患者的試驗。

Leonid Timoshev, RBC CM.

Leonid Timoshev，RBC CM。

Hi, guys. Josh on for Leo here. Thanks for taking my question. So with the physician discretion coming after the one to two recommended doses to COMP60, given that you've been doing these surveys of psychiatrists, what kind of feedback might you have been hearing from docs on expected dosing schedules, and how widely might that feedback have varied? Thanks.

嗨，各位。我是 Josh，代替 Leo 發問。謝謝讓我提問。關於在 COMP60 建議的一到兩次劑量之後，醫師可依裁量決定後續用藥；鑑於你們一直在做精神科醫師的調查，你們從醫師那邊聽到對預期給藥時程有什麼樣的回饋？而這些回饋的差異幅度大概有多大？謝謝。

Yes. Hi, Josh. Thanks for the question the surveys that we're doing are based on a product profile of COMP360 and what we've seen through our Phase 3 clinical trials. And as I mentioned in my remarks, what we're seeing is overwhelming response to willingness to prescribe. And not only am I seeing numbers I've never seen before in my career, but even the facilitators of the market research are saying the exact same thing. They've never seen numbers this high in terms of willingness to prescribe.

是的。嗨，Josh。謝謝你的問題。我們所做的調查是以 COMP360 的產品特性（product profile）以及我們在第三期臨床試驗中看到的結果為基礎。正如我在發言中提到的，我們看到的是壓倒性地願意開立處方的回應。不僅我看到的數字是我職涯中前所未見的，連市場研究的執行方也說完全一樣。他們也從未見過在「願意開立處方」方面有這麼高的數字。

The reason that this is so exciting for physicians right now is truly because of the TRD patient population. TRD patient population, again, has one product or one drug product available to patients right now. And that drug product, although it does work for some patients, can be highly burdensome for patients.

之所以這件事現在讓醫師如此興奮，真正原因在於 TRD（治療抗拒型憂鬱症）患者族群。TRD 患者族群目前可用的產品或藥物只有一種。而那個藥物雖然對部分患者有效，但對患者而言可能是高度負擔的。

And so the dosing frequency becomes a real driver for these physicians and why they're so excited about it. We have not heard any hesitancy around that. And to be honest with you, it's going to be incumbent upon the sales team and our field teams to really help educate based on all the additional data that we will have available on what that frequency of dosing may look like.

因此，給藥頻率就成為這些醫師非常在意的驅動因素，也解釋了他們為何如此興奮。我們沒有聽到對此有任何猶豫。坦白說，接下來將取決於銷售團隊與我們的前線團隊，根據我們將取得的所有額外數據，去協助教育市場，讓大家了解那個給藥頻率可能會是什麼樣子。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

Good morning, and thanks for taking our question. It's a two-parter. From a value proposition perspective, what's the best way one could place COMP360's time-in-clinic in context versus products that might promise a two-hour or less duration in the clinic? And from a competitive perspective, what are your assumptions on whether there might be another FDA-approved psilocybin molecule within the first year of approval of COMP360?

早安，謝謝讓我們提問。我有兩個問題。從價值主張的角度，應該如何把 COMP360 的「在診所停留時間」放在脈絡中，並與那些可能主打在診所停留兩小時或更短的產品做比較？另外從競爭角度，你們對於在 COMP360 獲批後的第一年內，是否可能還會有另一個獲 FDA 核准的裸蓋菇素（psilocybin）分子上市，有什麼假設？

So thanks for the question, Suman. So I think as we have often said, duration in clinic is only one element of a product profile, yes? And I think from the perspective of the patient and the provider experience, it's not necessarily going to be the primary driver.

謝謝你的問題，Suman。我想我們常說，診所內的時間長短只是產品特性中的一個要素，對吧？而且我認為，從患者與醫療提供者的體驗角度來看，它不一定會是主要驅動因素。

Clearly, there's an efficacy and safety bar that's got to be cleared for any asset. But we actually do believe that the nature of the psilocybin experience is something that is inherently attractive to patients and providers. Also, as we've discussed in the past, even on an economic basis, as long as there remains capacity in the system, there is actually not a good economic argument for why shorter is better in terms of the ability to generate revenue per room, so and such.

很明顯，任何資產都必須跨過療效與安全性的門檻。但我們確實相信，裸蓋菇素體驗的本質對患者與醫療提供者而言本來就具有吸引力。此外，如同我們過去討論過的，即使從經濟角度來看，只要系統仍有產能，其實並沒有一個好的經濟論點能說明「越短越好」，例如以每個房間可產生的收入等來衡量也是如此。

Rudy Li, Wolfe Research.

Rudy Li，Wolfe Research。

Hey, thanks for taking my question. Just a quick follow-up to the market dynamics. So apparently there are a lot of discussion on short-duration versus long-duration psychedelics following the Lilly deal. So maybe in five years we have a couple options, different compounds, different duration, maybe different indications. So very exciting time, but maybe talk about your and understanding of the market dynamic with multiple psychedelic options and the positioning of COMP360 in the broader psychiatry space, depression, anxiety. Thanks.

嗨，謝謝讓我提問。我想就市場動態做個簡短追問。顯然在 Lilly 交易之後，市場對短時程與長時程迷幻藥有很多討論。所以也許五年後我們會有幾個選項，不同化合物、不同時長，可能也有不同適應症。這是非常令人興奮的時刻，但能否談談你們對於在有多種迷幻藥選項下的市場動態理解，以及 COMP360 在更廣泛精神醫學領域（憂鬱、焦慮等）中的定位？謝謝。

Yes. Hi, Rudy. So the good news is that psychedelics continue to produce very robust, very exciting data. And part of the reason why you are seeing these clinics, these Spravato-certified clinics, who are unable to support these multi-hour treatments is because this is a very exciting time for the field of mental health.

是的。嗨，Rudy。好消息是，迷幻藥持續產出非常強勁、非常令人振奮的數據。而你看到這些診所、這些 Spravato 認證診所，之所以無法支援這種數小時的治療，其中一部分原因是因為心理健康領域正處於非常令人振奮的時期。

And so they are growing very fast and they're growing in anticipation of additional options being available. These products don't work for everyone. And there are 4 million, in theory, at least 4 million patients who are underserved today and not being treated with an interventional treatment like a Spravato or an ECT or a TMS that is indicated and has shown and proven efficacy in this patient population.

因此它們成長非常快，並且是在預期未來會有更多選項可用的情況下擴張。這些產品並非對每個人都有效。而且理論上有 400 萬名、至少 400 萬名患者目前仍未被充分服務，沒有接受像 Spravato、ECT（電痙攣治療）或 TMS（經顱磁刺激）這類介入性治療；而這些治療在此患者族群中是有適應症、且已顯示並證實療效的。

And so these centers, regardless of duration, and because we have repeatedly talked about the economics not being a driver, it is really going to come down to patient preference in terms of what a patient starts, provider experience in terms of what that patient has to go through or what that site has to deal with when a patient is having their experience.

因此，這些中心不論療程時長如何——而且我們也反覆談到經濟因素並不是驅動因素——最終真正會取決於患者偏好：患者想先從哪一種開始；以及醫療提供者的經驗：患者在體驗過程中需要經歷什麼，或該站點在患者進行其體驗時需要如何應對。

And let's not forget that we're going to be on market -- potentially be on market first, and so we will have continued time to establish the leadership position that we are in, and we'll get some proven clinical efficacy while we're out there. In terms of economics for the sites, and I'll just double down on what Kabir said, earlier we have -- with our strategic collaboration partners as well as outside of that through our medical science liaisons, we are not finding anyone bringing up the fact that this is a longer treatment than the shorter acting as being a prohibiting factor to prescribing.

另外別忘了，我們可能會率先上市，因此我們將有更多時間去鞏固目前的領導地位，並在市場上累積已被證實的臨床療效。就站點的經濟性而言——我也再強調一次 Kabir 先前說的——無論是透過我們的策略合作夥伴，或是在此之外透過我們的醫學科學聯絡員（MSL），我們並沒有發現有人提出「這是較長療程、相較於短效方案」會成為開立處方的阻礙因素。

Thanks for the comment.

謝謝你的評論。

If you're wondering why we're channeling our inner Steve, we've allowed him to go on vacation.

如果你在想為什麼我們在模仿內心的 Steve，是因為我們讓他去度假了。

Steve is on vacation.

Steve 在度假。

Jay Olson, Oppenheimer.

Jay Olson，Oppenheimer。

Hey, congrats on all the progress, and thanks for taking our question. Maybe a big-picture question, recognizing that the company is acutely focused in the near term on the approval and successful launch of COMP360, looking ahead to after you've accomplished that objective in the next year or two, what will become the next major strategic priority for the company? Thank you.

嗨，恭喜你們取得所有進展，也謝謝你們回答我們的問題。我想問一個較宏觀的問題：我們理解公司短期內高度聚焦於COMP360的核准與成功上市；展望在未來一到兩年達成該目標之後，公司下一個主要的策略優先事項會是什麼？謝謝。

Thank you. So PTSD clearly is a strategic priority for us, so that study's underway, and we see that as a very important second indication. As we mentioned to earlier answers, we will -- we clearly have very interesting signals in a wide range of psychiatric conditions. And we will prioritize some of those to move forward.

謝謝。因此，PTSD顯然是我們的策略優先事項，相關研究正在進行中，我們認為這會是非常重要的第二個適應症。如同我們在先前的回答中提到的——我們在廣泛的精神科疾病上確實看到非常有趣的訊號。我們將優先挑選其中一些推進。

We will at some point, we have always been clear that from an ex-US perspective, we will probably likely need to partner, but that's something that we will address once we have US approval in mind. And then I think more broadly, this is a space where you continue to see a lot of innovation now with psychedelic assets and so on. We would see ourselves as a leader with hopefully a successful launch under our belt essentially being in a position to play a role in that and seeing what other assets may be available.

在某個時間點，我們一直很清楚，從美國以外（ex-US）的角度來看，我們很可能需要合作夥伴，但這會在我們以美國核准為前提之後再來處理。更廣泛地說，這個領域目前持續看到大量創新，包括迷幻藥資產等等。我們希望自己能成為領導者；在成功上市之後，基本上就能處於一個可以在其中扮演角色的位置，並觀察是否有其他資產可供取得。

Thank you.

謝謝。

Ben Burnett, Wells Fargo.

Ben Burnett，Wells Fargo。

Hi, thank you. I also want to ask about your efforts just to prepare and to train sites ahead of commercial adoption. Specifically, can you talk about what are your target sites? It's our understanding that the interventional psychiatry footprint sort of offerings for Spravato today is pretty expansive with some sites associated with university hospitals, others maybe more suburban. So I guess, can you just talk to your strategy here, and which centers do you plan to target initially and to offer training to initially? Thank you.

嗨，謝謝。我也想問你們在商業化採用之前，為準備與訓練各治療據點所做的努力。具體來說，你們能談談你們鎖定的目標據點是哪些嗎？我們的理解是，目前Spravato的介入性精神醫學（interventional psychiatry）據點版圖相當廣泛，有些據點與大學醫院相關，另一些可能更偏郊區。所以我想請你們談談你們在這裡的策略：你們計畫一開始鎖定哪些中心，並優先提供哪些中心訓練？謝謝。

Hi, Ben, and thanks for that question. So as I mentioned in remarks, and this is pretty widely known, there are about 8,000 sites right now. This number has grown dramatically quarter over quarter. It looks about adding about 500 per quarter at least. And again, that goes to just the excitement of potential additional options coming to market.

嗨，Ben，謝謝你的問題。如同我在發言中提到的，而且這也相當廣為人知，目前大約有8,000個據點。這個數字每一季都大幅成長。看起來至少每季增加約500個。同樣地，這反映了市場對於可能有更多選擇上市的興奮與期待。

The easiest way to answer you is we are going to have a field team that is out calling on all of these sites. They will be making sure that they cover all 8,000 sites to make sure that these sites, if they have a willingness to prescribe COMP360, that they are well-educated and well-trained and prepared to prescribe this product.

最簡單的回答方式是：我們會有一支外勤團隊去拜訪所有這些據點。他們會確保涵蓋全部8,000個據點，確保這些據點若有意願開立COMP360處方，能夠獲得充分教育、受過良好訓練，並準備好開立這項產品。

We are also going to call on physicians that may be in the system with a high number of TRD patients who are serving as referrers to these sites that can administer these products as well. Our target list will be quite extensive at launch and comprehensive.

我們也會拜訪體系內可能有大量TRD患者、並作為轉介者（referrers）將患者轉介至可施作這些產品之據點的醫師。我們在上市時的目標名單將相當廣泛且全面。

The other thing I think we're finding as we do some of our work is that the dosing profile of COMP360 and the potential dosing profile of COMP360 lends itself to a wider radius. So to your point earlier, if some of these are quite suburban, coming in for a once-a-week or every-other-week treatment, like those that are currently available, becomes quite difficult for someone within a certain radius of a treatment center.

另外，我想我們在進行部分工作時發現，COMP360的給藥特性，以及其潛在的給藥方案，使其適用於更大的服務半徑。因此，回到你先前的觀點，如果其中一些據點相當偏郊區，像目前可用的治療那樣需要每週一次或每兩週一次到院治療，對於在治療中心一定距離範圍內的患者而言會變得相當困難。

Even though these centers are growing very rapidly, there are still some patients who need to drive quite a ways to access one of these treatment centers. Within infrequent dosing, like COMP360 proposes, this does open up that ability quite a bit.

即使這些中心的數量成長非常快速，仍有一些患者需要開車很遠才能到達其中一個治療中心。在像COMP360所提出的低頻率給藥情境下，這確實能大幅提升可近性。

We have reached the end of the Q&A session. I will now turn the call back to management for closing remarks. Please go ahead.

問答環節到此結束。我現在把電話交回管理層作結語。請開始。

Thank you very much all for attending. As you heard, the first six months, or I guess the first six months and one week of this year, have been a very exciting and very productive time for Compass. With the Phase 3 data now, both the primary endpoints, very statistically significant positive primary endpoints from both studies, and now the 26-week data from both studies confirming the profile of COMP360 as a compelling, differentiated profile that truly can serve to meet huge unmet needs in treatment-resistant depression.

非常感謝各位出席。如各位所聽到的，今年前六個月——或者說前六個月又一週——對Compass而言是非常令人振奮且非常高產的一段時間。隨著第3期數據出爐，兩項研究的主要終點皆呈現高度統計顯著的正向結果；而且現在兩項研究的26週數據也確認了COMP360的特性，展現出具吸引力且差異化的輪廓，確實能協助滿足治療抗性憂鬱症（TRD）中巨大的未被滿足需求。

So we're focused on execution. We're very happy with the process of the rolling review. As I said, we're preparing not just to finalize that, to fulfill that with that expected to complete in fourth quarter, but really ensuring it's a really high-quality dossier so we get a first-class approval. And as you've heard from Lori, there's activity across an extraordinary range of fronts on the commercial side to be ready for launch. So we look forward to keeping you updated on our progress on both of these major work streams through the end of this year. So thank you again. It is a very exciting time for patients with TRD. Thank you.

因此我們專注於執行。我們對於滾動式審查（rolling review）的流程感到非常滿意。如我所說，我們不僅在準備完成該流程、並履行相關要求（預期在第四季完成），更重要的是確保提交一份高品質的申請資料（dossier），以取得一流的核准。而且如各位從Lori那裡聽到的，在商業端有一系列跨越極其廣泛面向的活動，為上市做好準備。因此，我們期待在今年底前，持續就這兩條主要工作主軸的進展向各位更新。再次感謝。對TRD患者而言，這是一個非常令人振奮的時刻。謝謝。

This concludes today's call. Thank you for attending. You may now disconnect.

今天的電話會議到此結束。感謝各位出席。您現在可以掛線。