Compass Pathways PLC (CMPS) 2025 Q3 法說會逐字稿

Good morning, ladies and gentlemen, and thank you for standing by. My name is Kelvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Compass Pathways third-quarter 2025 earnings call. (Operator Instructions)

女士們、先生們，早安，感謝各位的耐心等待。我叫凱爾文，今天我將擔任你們的會議接線生。在此，我謹代表 Compass Pathways 公司歡迎各位參加 2025 年第三季財報電話會議。（操作說明）

I would now like to turn the call over to Stephen Schultz, Compass Pathways' Senior Vice President of Investor Relations. Please go ahead.

現在我將把電話交給 Compass Pathways 的投資人關係資深副總裁 Stephen Schultz。請繼續。

Welcome, all of you, and thank you for joining us today for this quarterly conference call. 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 Teri Loxam, our Chief Financial Officer. Lori Englebert, our Chief Commercial Officer; and Dr. Steve Levine, our Chief Patient Officer, will be available for the Q&A.

歡迎各位，感謝各位今天參加我們的季度電話會議。我是 Compass Pathways 的投資人關係資深副總裁 Steve Schultz。今天，與我一同出席的還有我們的執行長 Kabir Nath 和財務長 Teri Loxam。我們的首席商務長 Lori Englebert 和首席病患長 Steve Levine 博士將出席問答環節。

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.

本次電話會議正在錄音，錄音將在會議結束後不久發佈在 Compass Pathways 的投資者關係網站上，並保留 30 天。在開始之前，請允許我提醒大家，在今天的電話會議中，團隊將根據 1995 年《私人證券訴訟改革法案》（經修訂）的規定，發表前瞻性聲明。

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 quarterly report on Form 10-Q 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，實際事件或結果可能與任何前瞻性聲明中明示或暗示的內容存在重大差異，包括我們在最近向美國證券交易委員會提交的 10-Q 表格季度報告以及 Compass 隨後向美國證券交易委員會提交的文件中“風險因素”標題下描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.

此外，這些前瞻性陳述僅代表我們截至今日的觀點，不應被視為代表我們截至任何後續日期的觀點。即使我們的估計或假設發生變化，我們也不承擔更新或修改任何前瞻性陳述的義務。

I will now hand the call to Kabir Nath.

現在我將把電話交給卡比爾·納特。

Thank you, Steve, and thank you all for joining us for today's call. We are very excited that Compass continues to make excellent progress on all fronts, in particular, the potential 9- to 12-month acceleration of our launch plans that we announced today. Our first Phase 3 trial, COMP005, demonstrated a highly statistically significant result for the primary endpoint in June, which was an important derisking event for the company.

謝謝史蒂夫，也謝謝各位參加今天的電話會議。我們非常高興地看到 Compass 在各個方面都繼續取得優異的進展，特別是我們今天宣布的發布計劃有可能在 9 到 12 個月內加速完成。我們的第一個 3 期試驗 COMP005 在 6 月的主要終點方面取得了具有高度統計意義的結果，這對公司來說是一個重要的降低風險的事件。

It was also a clinically and commercially meaningful result which points to the potentially differentiated profile that is emerging for COMP360. We're looking forward to the remaining data from our ongoing Phase 3 trials, especially from the second Phase 3 COMP006 trial with its two fixed doses, which will be important to help inform dosing for labeling.

這同時也是一個具有臨床和商業意義的結果，顯示 COMP360 可能具有差異化優勢。我們期待正在進行的 3 期試驗的剩餘數據，特別是來自第二個 3 期 COMP006 試驗的數據，該試驗有兩個固定劑量，這將對幫助確定標籤劑量非常重要。

Enrollment for the 006 trial continued to accelerate throughout the summer. And today, we're pleased to announce the completion of enrollment. This is great news, since it clarifies timing for the remaining Phase 3 data disclosures and gives us line of sight to our potential filing timeline. Following the data readout in June, we had a positive and collaborative interaction with the FDA on our filing strategy for COMP360 in TRD. We're encouraged by their support for acceleration of the planned NDA filing, including the potential for a rolling submission.

整個夏季，006試驗的招募人數持續加速成長。今天，我們很高興地宣布招生工作已經完成。這是個好消息，因為它明確了剩餘的 3 期資料揭露時間，並讓我們對可能的申報時間表有了更清晰的了解。在 6 月公佈數據後，我們與 FDA 就 COMP360 在 TRD 中的申報策略進行了積極的合作互動。我們對他們支持加快計劃中的 NDA 申請流程表示鼓舞，包括有可能採取滾動提交的方式。

To enable this, we now plan to unblind nine-week data from Part A of the 006 trial and disclose it concurrently with 26-week data from the 005 trial in Q1, which is likely to be in the later part of the quarter. The 26-week data from COMP006 is now expected in early Q3 next year, which we anticipate will be the last gating item to complete our NDA submission.

為了實現這一目標，我們現在計劃在第一季（很可能是本季的後期）揭開 006 試驗 A 部分的九週數據，並與 005 試驗的 26 週數據同時披露。COMP006 的 26 週數據預計將於明年第三季初公佈，我們預計這將是完成 NDA 提交的最後一個關鍵項目。

Given the accelerated timelines, we are also pulling forward our launch readiness, building on the significant progress we've already made over the last couple of years. With our strategic collaborations across a variety of care settings and our medical science liaisons interactions with KOLs, we've been very active in developing an extensive understanding of the commercial landscape and of provider sentiment and dynamics.

鑑於時間緊迫，我們也加快了發布準備工作，並在過去幾年取得的顯著進展的基礎上繼續推進。透過我們在各種護理環境中的策略合作，以及我們的醫學科學聯絡員與關鍵意見領袖的互動，我們一直非常積極地深入了解商業環境以及提供者的想法和動態。

We've generated valuable learnings that we're incorporating into our launch plans, including insights into patient preference, patient flows and provider economics which have helped us understand how COMP360 will be differentiated from current and future treatment options if approved.

我們已經累積了寶貴的經驗，並將其融入我們的上市計劃中，包括對患者偏好、患者就診流程和醫療服務提供者經濟狀況的洞察，這些都幫助我們了解瞭如果獲得批准，COMP360 將如何與當前和未來的治療方案區分開來。

We're encouraged by the continued increase in interventional psychiatry infrastructure over the past few years, driven both by Spravato and the excitement around the potential promise for psychedelic treatments such as COMP360 in the future. The learnings we've gained through our commercial work strengthen our confidence that COMP360, if approved, can be effectively integrated into the growing interventional psychiatry infrastructure and offer a differentiated and compelling treatment option for patients and providers.

過去幾年，介入精神病學基礎設施的持續成長令我們感到鼓舞，這既得益於 Spravato 的發展，也得益於人們對未來迷幻療法（如 COMP360）潛在前景的興奮。我們在商業工作中獲得的經驗增強了我們的信心，如果 COMP360 獲得批准，它可以有效地融入不斷發展的介入性精神病學基礎設施，並為患者和醫療服務提供者提供差異化和引人注目的治療選擇。

With significant learnings already incorporated, we are confident that we will be ready to launch on an accelerated time frame which is great news for the estimated 3 million individuals in the US living with TRD. Beyond TRD, we're also finalizing the design for a late-stage PTSD trial following constructive interaction with the FDA.

憑藉著已經累積的大量經驗，我們有信心能夠加快啟動速度，這對美國約 300 萬患有難治性憂鬱症的人來說是個好消息。除了 TRD 之外，在與 FDA 進行建設性互動後，我們也正在最終確定一項後期 PTSD 試驗的設計。

We look forward to updating you further on that program in the near future. As you can see, these are exciting times for Compass, and we are focused on translating our progress into real-world patient impact as quickly as possible as the need remains urgent.

我們期待在不久的將來向您提供該項目的更多最新資訊。如您所見，對於 Compass 而言，這是一個令人興奮的時刻，我們專注於盡快將我們的進展轉化為對現實世界患者的影響，因為需求仍然非常迫切。

With that, let me turn it over to Teri.

那麼，接下來就交給泰瑞吧。

Thank you, Kabir. At the end of September, we had cash and cash equivalents of $186 million compared with $222 million at the end of the second quarter. We have continued to be disciplined in our spending, which has allowed us to maintain our cash runway into 2027. Debt under the Hercules loan facility was $31.3 million at the end of the third quarter.

謝謝你，卡比爾。截至 9 月底，我們的現金及現金等價物為 1.86 億美元，而第二季末為 2.22 億美元。我們一直嚴格控制支出，這使我們能夠維持現金流到 2027 年。截至第三季末，Hercules貸款項下的債務為3,130萬美元。

Cash used in operations for the third quarter was $35 million, and we expect net cash used in operations for the full-year 2025 to be between $120 million and $145 million. This range includes the amount receivable in respect to the R&D tax credit in the UK, the timing for which is uncertain. As Kabir mentioned, our entire team is focused on strong execution, completing both of our Phase 3 trials, preparing for our NDA submission and continuing our commercial preparations.

第三季經營活動所用現金為 3,500 萬美元，我們預期 2025 年全年經營活動所用現金淨額將在 1.2 億美元至 1.45 億美元之間。此範圍包括英國研發稅收抵免的應收金額，但具體到帳時間尚不確定。正如 Kabir 所提到的，我們整個團隊都專注於高效執行，完成我們的兩項 3 期試驗，準備提交 NDA，並繼續進行商業準備。

We have added resources to our regulatory team to ensure we're moving our NDA filing activities forward as quickly as possible, and we have also pulled forward select commercial activities to meet our new accelerated timelines. We are confident in the emerging profile for COMP360 and its potential to transform the landscape for those living with TRD and PTSD through a potentially rapid and durable treatment option, reinforcing our leadership in the field of psychedelics.

我們已向監管團隊增加了資源，以確保我們盡快推進 NDA 申報活動，並且我們還提前開展了一些商業活動，以滿足我們新的加速時間表。我們對 COMP360 的新興前景充滿信心，它將透過一種可能快速且持久的治療方案，改變患有 TRD 和 PTSD 的人們的生活，從而鞏固我們在迷幻藥領域的領先地位。

As mentioned at the beginning of the call, Lori Englebert and Dr. Steve Levine will also be available for the Q&A.

正如通話開始時所提到的，Lori Englebert 和 Steve Levine 博士也將參與問答環節。

Thank you, and I'll now turn the call back to the operator for Q&A.

謝謝，我現在將把電話轉回給接線生進行問答環節。

(Operator Instructions) Josh Schimmer, Cantor.

（操作說明）Josh Schimmer，坎托爾。

Congrats on the update and timelines. Quick question about selection of specialty pharma partner you may use to kind of support patient access. Have you identified any that you would anticipate to move forward with? And would there need to be any unique capabilities that they have in terms of offering those patient support services to psychiatrists who would be interested in prescribing psilocybin?

恭喜你們完成了更新和時間安排。關於選擇專科製藥合作夥伴以支持患者取得藥物的問題，請問一下？您是否已經確定了任何您打算推進的專案？那麼，在向有興趣開立裸蓋菇素處方的精神科醫生提供患者支持服務方面，他們是否需要具備任何獨特的能力？

Josh, it's Lori. Thanks for the question. We have not made a selection yet. It's a little bit too early to do that. But as Kabir mentioned in the opening remarks, we have done quite a considerable amount of work already in terms of understanding what the distribution pathway might look like to these treatment centers and how that might flow. And now that we're starting to accelerate some of those activities, you can expect that we will start narrowing down what that looks like in the coming months.

喬希，我是洛瑞。謝謝你的提問。我們尚未做出選擇。現在做這件事還為時過早。但正如卡比爾在開場白中提到的那樣，我們已經做了相當多的工作來了解這些治療中心的配送途徑可能是什麼樣的，以及配送過程會如何進行。現在我們開始加快推進其中一些活動，您可以期待在接下來的幾個月裡，我們將開始逐步明確這些活動的具體形式。

With regards to your question about any special requirements, again, we're looking through what that might require in terms of how we will support patients once we get to market. But there should be nothing unique that psychiatrists are unfamiliar with.

關於您提出的任何特殊要求的問題，我們正在研究一旦產品上市後，我們將如何為患者提供支持，這可能需要哪些條件。但對於精神科醫師來說，應該沒有什麼特別之處是他們不熟悉的。

Okay. Got it. And then if I may ask one other quick question. You mentioned that sites that are able to administer Spravato currently should be able to administer COMP360. Does that apply to every single site? Or what incremental changes to the office or practice might be needed to incorporate COMP360 into the 6,000 or so sites capable of delivering Spravato currently?

好的。知道了。那麼，我可以再問一個問題嗎？您提到目前能夠管理 Spravato 的站點應該也能管理 COMP360。這適用於所有網站嗎？或者，要將 COMP360 納入目前能夠提供 Spravato 的約 6,000 個站點，可能需要對辦公室或實踐進行哪些逐步的變更？

Josh, thanks for that question. It's Steve Levine. The short answer is that we would expect that any site that is delivering Spravato today would be capable of delivering COMP360, if approved. That doesn't mean that it's necessarily one for one in the implementation, but it's exactly why we're doing the work we are with the collaboration sites or strategic collaborations to understand what any incremental changes might be needed.

喬希，謝謝你的提問。是史蒂夫·萊文。簡而言之，我們預計任何目前能夠提供 Spravato 的網站，如果獲得批准，都將有能力提供 COMP360。但這並不意味著實施過程中必須一一對應，但這正是我們與合作網站或策略夥伴進行工作的原因，以便了解可能需要的任何漸進式變化。

But in terms of the physical infrastructure, the staffing, the capabilities, those all port over directly from their current experience with Spravato.

但就基礎設施、人員配備、能力而言，這些都直接繼承了他們目前在 Spravato 的經驗。

Paul Matteis, Steel.

保羅·馬泰斯，鋼鐵。

So as it relates to this FDA meeting, I think, you said previously that the thought was you were only going to be sharing with the agency the same level of granularity on the 005 data that we've seen, and I think you've still -- since just seen as well. To that point, do you feel like there's the need to have another FDA engagement after you release this much more detailed data early next year?

所以，關於這次與 FDA 的會議，我想，你之前說過，你的想法是只會與該機構分享我們已經看到的 005 數據的相同細粒度級別，而且我認為你現在仍然——也剛剛看到了。有鑑於此，您是否覺得在明年初發布這些更詳細的數據後，有必要再次與FDA溝通？

And then I guess as a second question related to that, can you help set up what your expectation is when we see 26-week data? And what do you think would be a positive outcome on either the frequency of retreatment or response rates for retreatment that would align with your target product profile as it relates to what you're looking for durability and just kind of the commercial sort of viability and scalability?

那麼，我想就此提出第二個問題，您能否幫忙說明一下，當我們看到 26 週的數據時，您的預期是什麼？您認為在重複治療的頻率或重複治療的反應率方面，什麼樣的正面結果才能符合您的目標產品特性，即您所追求的耐用性、商業可行性和可擴展性？

Thanks, Paul. So yes, on the first one, you're right. From a data perspective, we have no more data in hand. But clearly, we were able to share with the agency, some of what we've announced today in terms of timelines, where we were with 006 and so on. So there was information that we were able to share at that point with them.

謝謝你，保羅。是的，第一個問題你說得對。從數據角度來看，我們目前沒有更多數據了。但很顯然，我們能夠與該機構分享我們今天宣布的一些內容，例如時間表、006 的進展等等。所以當時我們能夠與他們分享一些資訊。

To your point, absolutely, we would expect with the significant data readouts in quarter one, that would indeed be the point for another meeting with the agency really to align fully on the plan going forward in terms of rolling submission, what's going to be reviewed when and so on. So yes, that is absolutely the case.

你說得對，我們預計在第一季度公佈重要數據後，確實應該與相關機構再次會面，以便就未來的計劃達成完全一致，包括滾動提交、審查時間等等。是的，情況確實如此。

For the profile, I'll actually hand to Lori to talk a little bit about that. And again, though, I'd just remind you, contextualize, we are now going to be announcing 26 weeks from 005 together with the nine-week data from 006.

至於個人簡介部分，我將交給洛里來簡單談談。不過，我還是要提醒大家，為了方便理解，我們現在將公佈 005 年以來的 26 週數據，以及 006 年以來的 9 週數據。

Yes. Paul, thanks for the question. So what we expect to see, and let me just remind you, in order to achieve equivocal efficacy to Spravato, Spravato patients need to receive 8 to 10 treatments to our one that was already demonstrated at the six-week timeline.

是的。保羅，謝謝你的提問。因此，我們預期會看到，而且我還要提醒大家，為了達到與 Spravato 相當的療效，Spravato 患者需要接受 8 到 10 次治療，而我們的治療方案已經在六週內證明了療效。

So already, we are quite differentiated from what's available to TRD patients right now. Everything we see in the 26-week data will only help accentuate what the clinical profile of the product is going to be. And I do want to just caveat that the 005 26-week data that we will release in quarter one is after one administration.

所以，我們目前與TRD患者可獲得的治療方案已經有了相當大的差異。我們從 26 週的數據中看到的一切，都將有助於凸顯該產品的臨床特性。我還要特別說明一下，我們將在第一季發布的 005 26 週數據是在一個政府任期之後的數據。

The two administration that we will see with 006, we will also really be looking forward to what that profile looks like at the 26-week data for 006. In terms of commercial viability, as I mentioned, we're already highly differentiated with the one administration getting such profound efficacy in a TRD indicated population. So anything on top of that in terms of durability will help accentuate that product profile.

我們將看到 006 的兩屆政府，我們也非常期待 006 的 26 週資料會呈現出怎樣的面貌。就商業可行性而言，正如我所提到的，我們已經與一種在難治性憂鬱症患者群體中取得顯著療效的給藥方式形成了高度差異化。因此，任何在耐用性方面有所提升的功能都將有助於突顯該產品的特色。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

Congrats on the progress here. Just curious if any of the interactions with the FDA included conversation around submissions for the commissioner's priority review application. I think you had said at some point, you did have interactions with the agency on that submission. And if not, has the agency pointed toward TRD versus PTSD in any way being higher areas of unmet need in their view?

恭喜你們的進展。我只是好奇與FDA的互動中是否涉及了關於提交專員優先審查申請的討論。我想你之前說過，你曾經就那份申請與該機構進行過溝通。如果沒有，該機構是否指出，在他們看來，TRD（難治性憂鬱症）與 PTSD（創傷後壓力症候群）相比，是未滿足需求的更高領域？

Yes. So thanks, Judah. Yes, as we've said before, we did apply for a CNPV. But we know that hundreds, perhaps thousands of companies applied for CNPV. There was some interaction. But obviously, we've seen the first list. We're aware the commissioner said that there may be more coming. But really, I think our discussions have been with the division, and that's where we've had the very positive feedback that there is momentum there and so on.

是的。謝謝你，猶大。是的，正如我們之前所說，我們確實申請了CNPV。但我們知道，可能有數百家公司申請了 CNPV。雙方進行了一些互動。但很顯然，我們已經看到了第一份名單。我們了解到專員曾表示可能會有更多措施出台。但實際上，我認為我們一直在與該部門進行討論，並且我們從中得到了非常積極的反饋，表明這方面勢頭良好等等。

From an agency perspective, I think they see both TRD and PTSD as areas in desperate need of new options for patients. I don't know that at the agency level as opposed to shall we say at the political level, there's any distinction there. We are clearly the most advanced with our program, which is in TRD. And I think we have a very good relationship and good understanding of the urgency of trying to move that forward, subject to data.

從機構的角度來看，我認為他們認為 TRD 和 PTSD 都是亟需為患者提供新治療方案的領域。我不認為在機構層面與政治層面有什麼區別。我們的專案顯然是最先進的，該專案屬於 TRD 領域。我認為我們關係很好，也充分理解了在數據指導下推動這項工作的迫切性。

Okay. Maybe just a quick follow-up. Any interaction or commentary from the VA within these agency conversations? Or do those kind of weigh on their decision-making there?

好的。或許只需要簡單跟進。退伍軍人事務部在這些機構對話中是否有任何互動或評論？或者說，這些因素會對他們的決策產生影響嗎？

So I don't think we could comment on how the VA and FDA interact, but I'll turn to Steve to talk about our interactions with the VA kind of independent of that.

所以我覺得我們無法評論退伍軍人事務部和食品藥物管理局之間的互動，但我會請史蒂夫談談我們與退伍軍人事務部的互動，這與此無關。

Thanks, Kabir. Judah, yes, we have regular engagement with the VA and have for quite some time now. About 1 year, 1.5 years ago, the VA convened an integrated project team that is specifically tasked with early thinking and planning for the implementation of psychedelic treatments, if approved.

謝謝你，卡比爾。猶大，是的，我們與退伍軍人事務部一直保持著定期聯繫，而且已經有一段時間了。大約 1 年到 1.5 年前，退伍軍人事務部召集了一個綜合計畫團隊，專門負責對迷幻療法的實施進行早期思考和規劃（如果獲得批准）。

And that includes senior VA leadership within the Office of Mental Health. We engaged with them on a regular basis. We provided many resources for them to help guide their thinking about what they will need to ensure that there is access within the VA upon approvals. And so that's been a very positive set of interactions.

這其中也包括退伍軍人事務部心理健康辦公室的高階領導階層。我們與他們保持定期聯繫。我們為他們提供了許多資源，以幫助他們思考在獲得批准後，他們需要哪些資源來確保在退伍軍人事務部獲得服務。所以，這是一系列非常積極的互動。

Gavin Clark-Gartner, Evercore ISI.

Gavin Clark-Gartner，Evercore ISI。

Congrats on the update. So by presenting the 006 data at nine weeks, do you risk the integrity of the study in any way? Like I know that was part of FDA discussions previously. So I'm curious what led regulators to change their stance? And also curious if by presenting this data at an earlier time point, do you lose the commercial ability to make claims around the durability of the two-dose regimen?

恭喜您更新成功。那麼，在九週時公佈 006 數據，是否會以任何方式損害研究的完整性？我知道這曾是FDA之前討論過的內容之一。所以我很好奇哪些LED穩壓器會改變它們的姿態？另外，我很好奇，如果在更早的時間點公佈這些數據，是否會失去對兩劑療法的持久性做出商業聲明的能力？

No. So to be clear, Gavin, I mean, it was our choice in the past, you'll recall that we actually changed guidance from disclosing Part A of 006 to only disclosing the 26-week data in the light of, shall we say, a lot of the confusion and commentary around Lykos at the time. A few things are clearer.

不。所以說清楚點，Gavin，我的意思是，這是我們過去的選擇，你應該記得，鑑於當時圍繞 Lykos 的諸多混亂和評論，我們實際上改變了指導方針，從披露 006 年的 A 部分改為僅披露 26 週的數據。有些事情更清楚了。

First, given that CRL was published, it actually does not focus on functional unblinding and expectancy as a key issue. There were a whole lot of other deficiencies as well. Second, we will actually have the vast majority of patients through Part B of 006 by the time we disclose data from Part A.

首先，鑑於 CRL 已經發表，它實際上並沒有將功能性揭盲和預期作為關鍵問題。此外，還有許多其他方面的不足。第二，到我們公佈 A 部分的數據時，實際上絕大多數患者都將完成 006 年 B 部分。

And in our perspective, that does not, in any way, compromise what we may see in Part B, which would also be integral to claims.

在我們看來，這絲毫不會影響我們在 B 部分中看到的內容，而 B 部分的內容對於索賠也是至關重要的。

I don't know, Lori, if you want to just build on that?

洛莉，我不知道你是否想以此為基礎繼續發展？

No, I agree. And just a reminder, it is double blinded through 26 weeks. So as we present that data to the agency, there should be no hesitation in terms of how we implement based on that data.

不，我同意。再次提醒一下，這項研究採用雙盲設計，持續 26 週。因此，當我們向該機構提交這些數據時，對於如何根據這些數據進行實施，我們應該毫不猶豫。

All right. Great. That is super helpful. And just a separate topic. What's your current assumption for how the label or the REMS may read on monitoring requirements? Like specifically, I'm wondering if a single versus a group room may be required and if one health care provider can monitor multiple people simultaneously and if any of this was discussed in the Type B.

好的。偉大的。這太有幫助了。這是另一個話題。您目前對標籤或REMS中​​關於監測要求的表述有何假設？具體來說，我想知道是否需要單人病房還是多人病房，以及一名醫護人員是否可以同時監測多人，以及 B 類中是否討論過這些問題。

Thanks, Gavin. It's Steve Levine. It's a great question. I think what you should anticipate is that the label or REMS will not necessarily get into granular detail about the practice of medicine and the delivery of treatment to patients, so much as describing how the studies were conducted. It would be expectable that at the time closest to launch, most sites would likely deliver this treatment in the most conservative way possible with one patient occupying a private room as Spravato is often delivered today.

謝謝你，加文。是史蒂夫·萊文。這是一個很好的問題。我認為你應該預料到的是，標籤或 REMS 不一定會詳細說明醫療實踐和對患者的治療，而更多的是描述研究是如何進行的。可以預見的是，在最接近上市的時候，大多數治療中心可能會以最保守的方式進行治療，就像目前 Spravato 的治療方式一樣，讓一名患者單獨住在一個房間裡。

But also taking lessons from Spravato, it's also likely that as clinicians gain more experience and comfort with delivering COMP360, they likely will find additional efficiencies in delivering it and that could include group administration. It could include rooms with curtain bays, et cetera, ways that allow them to move patients efficiently through their centers. And this is also work that we've been exploring in some early work with our strategic collaborations.

但從 Spravato 的經驗來看，隨著臨床醫生在實施 COMP360 方面累積更多經驗和信心，他們可能會發現實施該方案的更多效率，其中可能包括小組管理。它可能包括有簾子隔間的房間等等，這些方式可以讓他們在中心內有效率地轉移病人。這也是我們在早期策略合作中一直在探索的工作。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

This is Athena Chin on for Ritu. Could you please review the state of your commercialization preparation for 360 and provide more color on what activities you pulled forward given the accelerated timelines? And then I have another follow-up.

這是 Athena Chin 為 Ritu 帶來的報導。請您回顧 360 的商業化準備情況，並詳細說明鑑於時間緊迫，您提前開展了哪些活動？然後我還有後續問題。

Athena, thanks for the question. So as Kabir mentioned in the prepared remarks, we have done some really incredible work over the past couple of years, specifically with our strategic collaborations as well as our MSLs and then a whole host of other critical components of a commercial preparation such as government affairs, (inaudible), we've done some market access work.

雅典娜，謝謝你的提問。正如 Kabir 在準備好的發言稿中提到的那樣，在過去的幾年裡，我們做了一些非常了不起的工作，特別是我們的戰略合作以及我們的醫學聯絡官，還有商業準備的許多其他關鍵組成部分，例如政府事務，（聽不清）我們做了一些市場准入工作。

All of that to get prepared for a real solid understanding of what strategy should be. What that actually means is that we understand the marketplace landscape, we understand where the prescribers -- who the prescribers are, where they are, how we might want to ensure that they can seamlessly integrate COMP360 into their treatment practice as it stands today.

這一切都是為了真正透徹理解戰略的本質。實際上，這意味著我們了解市場格局，了解處方醫生在哪裡——處方醫生是誰，他們在哪裡，以及我們希望如何確保他們能夠將 COMP360 無縫地整合到他們目前的治療實踐中。

What we will pull forward and start shifting to is your more fundamental traditional commercial activities like marketing, messaging, figuring out how to structure a sales force, getting an IT infrastructure set up and prepare to ingest data as the sales reps are out in the field. And of course, a lot of that comes with also some market access and payer discussions around the potential to reimburse the product. So we are pulling those forward by several months.

我們將推進並開始轉向更基礎的傳統商業活動，例如行銷、資訊傳遞、制定銷售團隊架構、建立 IT 基礎設施以及準備在銷售代表外出工作時收集資料。當然，這其中也涉及到市場准入和支付方就產品報銷的可能性進行的討論。因此，我們將這些項目提前幾個月完成。

And obviously, a lot of that will be contingent, especially the payer discussions will be contingent upon the durability data and a complete understanding of what the 006 data looks like so that we can put together a very nice picture for what the full clinical profile of COMP360 will be to engage in the payer discussions.

顯然，很多事情都將取決於具體情況，特別是與支付方的討論將取決於持久性數據以及對 006 數據的全面了解，以便我們能夠全面了解 COMP360 的臨床概況，從而與支付方進行討論。

But a lot of that is not contingent upon doing marketing activities and sales force sizing and things like that to prepare. So we will be ready based on the fact that we have a very strong strategy in place, and we are just pulling forward some of the execution activities.

但很多事情並不取決於開展行銷活動、組建銷售團隊以及諸如此類的準備工作。鑑於我們已經制定了非常強有力的策略，我們將做好準備，現在只是提前進行一些執行活動。

Got it. And on the filing, are there any outstanding drug liking requirements that are needed or ongoing? And when can we expect those to complete?

知道了。關於備案事宜，是否有任何未決的藥物相似性要求是必要的或正在進行的？這些項目預計何時完成？

No. So as we said on the call, we do expect 26-week data from 006 to be the final gating item. So everything else in terms of preclinical, CMC, stability, et cetera, will be well in hand before all that. So no, there are going to be no other outstanding requirements.

不。正如我們在電話會議上所說，我們預計 006 的 26 週數據將是最後一個決定性因素。因此，在臨床前研究、CMC、穩定性等方面的其他所有事情，都會在此之前得到很好的處理。所以，沒有其他未完成的要求了。

Patrick Trucchio, HC Wainwright.

Patrick Trucchio，HC Wainwright。

The first question is just on the Type B meeting with the FDA. I'm wondering if there was any change from what had been discussed previously. Or just has the agency's tone or the way that they're talking to you about COMP360, has this changed from what you've heard previously, and particularly as it relates to the potential for the rolling submission and how we should think about that? And then I have a few follow-ups.

第一個問題是關於與FDA舉行的B類會議。我想知道與之前討論的內容相比，是否有任何變化。或者，該機構在與您談論 COMP360 時的語氣或方式是否與您之前聽到的有所不同，特別是關於滾動提交的可能性以及我們應該如何看待這一點？然後我還有幾個後續問題。

Yes. No, thanks, Patrick. So yes, I think it's fair to -- first, as we've consistently said, we have an excellent relationship with the division. We've had breakthrough designation now for a number of years. That's allowed us to have regular dialogue. I think it's been clear for some time that the division sees the potential in psychedelics in COMP360, they see the need. But at the same time, they're going to adhere to exactly the same high standards as they always have, and we're very happy with that, and we will continue to uphold those standards.

是的。不用了，謝謝你，派崔克。所以，是的，我認為公平起見——首先，正如我們一直所說，我們與該部門有著良好的關係。我們已經獲得突破性成果認定好幾年了。這使我們能夠進行定期對話。我認為，一段時間以來，很明顯，該部門看到了迷幻藥在 COMP360 中的潛力，他們看到了這種需求。但同時，他們將一如既往地堅持同樣的高標準，我們對此非常滿意，並將繼續維護這些標準。

But yes, I mean, traditionally psych has perhaps not been as forward-looking in terms of rolling submissions and so on as some other divisions. And so in that sense, there was, as we've said, encouragement, a very positive spirit around the meeting. And so in that sense, something of a change in tone, but again, in the context of the relationship that's always been excellent and a very supportive division.

但沒錯，我的意思是，傳統上，心理摔角在滾動降服等方面可能不像其他一些組別那樣具有前瞻性。因此，從這個意義上講，正如我們所說，會議期間充滿了鼓勵和非常積極的氣氛。因此，從這個意義上講，語氣上發生了一些變化，但同樣，在雙方關係一直很好、互相支持的大背景下，這種變化仍然存在。

Right. And then as we look ahead, first, is it still the anticipation that there would be an advisory committee? And as you prepare for this anticipated outcome, what key elements of the submission or support model would address questions around safety, support, mechanism of action, any of these other questions? And maybe also as this relates to learnings from that published CRL?

正確的。展望未來，首先，是否仍期待會成立一個諮詢委員會？當您為預期結果做準備時，提交或支援模型中的哪些關鍵要素可以解決有關安全性、支援、作用機制以及其他任何相關問題？或許這與已發布的 CRL 中的經驗教訓也有關？

And then separately, just on the commercial front. I think in the past, you've said there is roughly 6,000 interventional psychiatry centers capable of administering multi-hour treatment. So I'm wondering, at the time of launch, what proportion of those would be certified and able to deliver COMP360.

然後，另外，就商業方面而言。我記得你以前說過，大約有 6000 個介入精神科中心能夠提供數小時的治療。所以我想知道，在發佈時，其中有多少比例的產品能夠獲得認證並交付 COMP360 服務。

Okay. So that last one, I will hand to Steve in a moment. But the question around -- so obviously, it's the FDA's determination as to whether or not they want an advisory committee, and that will depend on when they actually receive data on the review package. All I can tell you is we will be ready. We are anticipating that, that may happen, and we will be ready for that.

好的。最後一個問題，我一會兒就交給史蒂夫。但問題在於——很顯然，是否要成立諮詢委員會取決於 FDA 的決定，而這取決於他們何時實際收到審查資料。我只能告訴你，我們會做好準備。我們預計這種情況可能會發生，我們會為此做好準備。

I think clearly, obviously, everyone now has access to the Lykos CRL which is helpful. But as we've always said, we have done a comprehensive job of collecting side effects, including positive, shall we say, side effects, euphoria and so on. So I think we have the data to characterize the risk benefit of COMP360 in the way you would expect of any drug.

我認為很明顯，現在每個人都可以訪問 Lykos CRL，這很有幫助。但正如我們一直所說，我們已經全面收集了副作用，包括正面的副作用，例如欣快感等等。所以我認為我們有足夠的數據來描述 COMP360 的風險效益，就像你對任何藥物所期望的那樣。

In addition, as we've said, the person in the room is there for safety. They're not there to direct therapy or to intervene, they are there for safety. We have had them trained to a very standardized protocol consistent across every arm of each study. And as we've talked about before as well, we are doing some sampling of that to ensure that that's in line with the education we've given and so on.

此外，正如我們所說，房間裡的人是為了安全起見。他們不是來指導治療或介入的，而是來保障安全的。我們已經對他們進行了非常標準化的培訓，該培訓方案在每項研究的每個組別中都保持一致。正如我們之前討論過的，我們正在進行一些抽樣調查，以確保其與我們提供的教育等內容相符。

So I think, obviously, as time evolves, we will look at our strategy, look at everything we're preparing in relation to the specific concerns that were raised by the agency either in the case of Lykos and other ones, but we will be ready for an advisory committee whatever happens. Steve?

所以我認為，很顯然，隨著時間的推移，我們會審視我們的策略，審視我們正在準備的一切，以應對該機構提出的具體關切，無論是 Lykos 的案例還是其他案例，但無論發生什麼，我們都會做好準備，成立一個諮詢委員會。史蒂夫？

Yes, this is Steve Levine. And as far as the second part of your question about the readiness of these Spravato interventional infrastructure to deliver COMP360 at launch, within our strategic collaborations, there already is a high representation of this concentrated delivery network that delivers Spravato today. But additionally, the bidirectional information exchange that happens within these collaborations helps us to not only understand how to best support these sites and patients at these sites so that they can be activated to deliver our treatment.

是的，這位是史蒂夫·萊文。至於你問題的第二部分，即 Spravato 介入治療基礎設施是否已準備好在上市時提供 COMP360，在我們的戰略合作中，目前已經有很高比例的集中交付網絡提供 Spravato。此外，這些合作中發生的雙向資訊交流不僅有助於我們了解如何最好地支持這些地點和這些地點的患者，以便他們能夠積極提供我們的治療。

But because they share characteristics with other interventional psychiatry practices, it allows us to build templates to also be ready to support them. But you'll also note that this network of collaborations isn't exclusively interventional psychiatry. It really reflects the diversity of sites of care where patients living with treatment-resistant depression receive their care today. And although we would expect that some of the earliest adopters would be the interventional psychiatry sites, we are committed to broaden equitable access and that means enabling access in a broader array of treatment sites.

但由於它們與其他介入性精神病學實踐具有共同特徵，因此我們可以建立模板，以便為它們提供支持。但您也會注意到，這種合作網絡並不完全局限於介入精神醫學。這真實地反映瞭如今患有難治性憂鬱症的患者接受治療的場所的多樣性。雖然我們預期最早採用者可能是介入精神醫學機構，但我們致力於擴大公平取得途徑，這意味著要在更廣泛的治療場所提供取得途徑。

Sumant Kulkarni, Canaccord Genuity LLC.

Sumant Kulkarni，Canaccord Genuity LLC。

Nice to see all the progress. I have a couple. As a point of clarification, what is the key variable that has allowed you to bring forward your timeline for commercialization by 9 to 12 months? Is that related primarily to an ability to submit an NDA for COMP360 for treatment-resistant depression ahead of your original plans? Or is it something else?

很高興看到取得的所有進展。我有一對。為了澄清一下，是什麼關鍵因素使你們能夠將商業化時間表提前 9 到 12 個月？這是否主要與您原計劃提前提交用於治療難治性憂鬱症的 COMP360 的新藥申請有關？還是另有隱情？

And second, is it fair to assume that you would need to have the Part A from COMP006 and Part B from COMP005 in hand to initiate a rolling NDA submission?

其次，是否可以合理地假設，要啟動滾動式 NDA 提交，您需要手邊有 COMP006 的 A 部分和 COMP005 的 B 部分？

Thanks, Sumant. So a couple of things. First, clearly, the completion of 006 enrollment that has come ahead of expectations. So you'll know that we were guiding until now for second half of '26 for the 26-week data from 006, so we've now tightened that to early Q3. So we've gained a number of months there from there.

謝謝你，蘇曼特。有兩件事。首先，很顯然，006 的招生工作已經提前完成。所以你們應該知道，我們之前一直將 2026 年下半年的業績預期（基於 2006 年 26 週的數據）調整為 2026 年第三季初。所以，從那以後，我們又爭取到了幾個月的時間。

And clearly, 006 has gone extremely well, particularly over the course of the summer with European sites in particular performing very strongly. So a big chunk of the acceleration comes from our execution on 006.Part of it then does come from the potential to have the agency start reviewing of some modules in line with a typical rolling submission, where, as you know, you can submit (inaudible) and CMC and so on ahead of the full package of clinical data. So there were clarifications around that in the meeting.

顯然，《006》的票房表現非常出色，尤其是在夏季，歐洲地區的票房表現特別強勁。因此，加速進展的大部分來自於我們對 006 的執行。其次，一部分來自於監管機構有可能開始審查一些模組，就像典型的滾動提交一樣，正如您所知，您可以在提交完整的臨床資料包之前提交（聽不清楚）和 CMC 等。所以會議上就此進行了一些澄清。

But yes, to your point and the earlier question, we would expect another meeting with the agency in quarter one with the data, the 26-week data from 005 and the 9-week data from 006 in hand. And that we would expect to be another meeting which would -- actually can formalize the plan going forward.

是的，關於您剛才提到的問題，我們預計在第一季會與該機構再次會面，屆時我們將掌握數據，即 005 年的 26 週數據和 006 年的 9 週數據。我們預計另一次會議將正式確定未來的計劃。

There are no further questions at this time. And with that, I will turn the call back to the management for closing remarks. Please go ahead.

目前沒有其他問題了。接下來，我將把電話轉回給管理階層，請他們作總結發言。請繼續。

Thanks, everyone, for participating today. As you've heard, we are extremely excited about this potential acceleration of 9 to 12 months, really based both on our execution around 006, also a good positive dialogue we've had with the agency as well as the decisions we've made about unblinding 006 data in the first quarter of next year.

謝謝大家今天的參與。正如你們所聽到的，我們對此次可能提前 9 到 12 個月完成感到非常興奮，這實際上既基於我們圍繞 006 項目的執行情況，也基於我們與代理機構進行的良好積極的對話，以及我們關於在明年第一季度揭盲 006 數據的決定。

I'd remind you again that we will be talking about PTSD in due course. We're excited about that. We have actually now finalized the protocol on that. We have selected a CRO, the protocol is with them for costing and so on. And so we look forward to announcing that and getting on with that with the potential to have first patient in that in the first quarter of next year as well.So very exciting times for Compass. We're thrilled with where we're at. We are ready to move on that accelerated timeline.

我再次提醒各位，我們遲早會談到創傷後壓力症候群（PTSD）。我們對此感到興奮。我們現在已經最終確定了相關協議。我們已經選定了一家合約研究組織 (CRO)，方案已交給他們進行成本核算等工作。因此，我們期待宣布這一消息，並繼續推進這項工作，並且有可能在明年第一季迎來首例患者。對Compass來說，這是一個令人振奮的時刻。我們對目前的狀況非常滿意。我們已準備好按加速後的時間表推進工作。

As you've heard from Lori and Steve as well today, a lot of activity on the commercial front, building on the learnings we already have. So we're looking forward to a very engaged and active next 12 to 15 months. Thanks, everyone, for taking part today.

正如你今天從 Lori 和 Steve 那裡聽到的，我們在商業方面有很多活動，都是在我們已經獲得的經驗基礎上進行的。因此，我們期待在接下來的 12 到 15 個月裡積極參與各項活動。謝謝大家今天的參與。

Ladies and gentlemen, this concludes today's call. We thank you for participating. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。