Compass Pathways PLC (CMPS) 2023 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Compass Pathways Fourth Quarter 2023 conference call. (Operator Instructions) As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz, you may begin.

女士們、先生們，美好的一天，歡迎參加 Compass Pathways 2023 年第四季電話會議。 （操作員說明）謹此提醒，此通話正在錄音。現在我想介紹一下今天電話會議的主持人史蒂芬舒爾茨（Stephen Schultz），請您開始。

Welcome all of you, and thank you for joining us today for our fourth quarter 2023 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; Mary Rose Hughes, our Interim Chief Financial Officer; Teri Loxam, our incoming Chief Financial Officer; and Dr. Guy Goodwin, our Chief Medical Officer. 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 archived for a period of 30 days.

歡迎大家，感謝您今天參加我們的 2023 年第四季業績電話會議。我的名字是 Steve Schultz，Compass Pathways 投資人關係資深副總裁。今天，我們的執行長 Kabir Nath 也加入了我的行列。瑪麗‧羅斯‧休斯 (Mary Rose Hughes)，我們的臨時財務長； Teri Loxam，我們即將上任的財務長；以及我們的首席醫療官 Guy Goodwin 博士。電話會議正在錄音，電話會議結束後不久將在 Compass Pathways 投資者關係網站上公佈，並存檔 30 天。

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. You should not place undue reliance on these forward-looking statements, actual events or results could differ materially from those expressed or implied by forward-looking statements.

在我們開始之前，讓我提醒大家，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》修訂案的含義做出前瞻性陳述。您不應過度依賴這些前瞻性陳述，實際事件或結果可能與前瞻性陳述明示或暗示的內容有重大差異。

As a result of various risks, uncertainties and other factors, including those risks and uncertainties described under the heading Risk Factors in our annual report on Form 10-K 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，包括我們向美國證券交易委員會提交的 10-K 表年度報告以及 Compass 向 SEC 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'll now hand the call over to Kabir Nath.

此外，這些前瞻性陳述僅代表我們今天的觀點，不應被視為代表我們在任何後續日期的觀點。即使我們的估計或假設發生變化，我們特別不承擔更新或修改任何前瞻性陳述的義務。我現在將把電話轉給卡比爾·納斯。

Thank you Steve. Good day, everyone, and thank you for joining us. Let me begin by thanking Mary Rose Hughes, our Interim Chief Financial Officer for her tremendous support over this last quarter. And let me welcome Teri Loxam back from climbing Mount Kilimanjaro and into the CFO role starting tomorrow, March 1. Teri brings to comfort the extensive strategic experience working for publicly traded companies in the pharmaceutical and biotech sector.

謝謝史蒂夫。大家好，感謝您加入我們。首先，我要感謝我們的臨時財務長瑪麗羅斯休斯 (Mary Rose Hughes) 在上個季度給予的大力支持。讓我歡迎 Teri Loxam 從攀登乞力馬扎羅山回來，並從明天 3 月 1 日開始擔任財務長。Teri 帶來了在製藥和生物技術領域上市公司工作的豐富策略經驗。

A broad experience through all stages of developments is precisely the expertise and leadership that Compass requires as we progress our Phase 3 program in treatment resistant depression. Many of you already know, Teri and I hope that over the coming months, the rest of you will have the opportunity to meet her. And in a moment, I'll ask her to provide a few thoughts on her new role at Compass.

在我們推動難治性憂鬱症的第三階段專案時，Compass 所需的專業知識和領導力正是在各個發展階段的廣泛經驗。你們中的許多人已經知道，泰瑞和我希望在接下來的幾個月裡，你們其他人將有機會見到她。稍後，我將請她為她在 Compass 的新角色提供一些想法。

First, though, let me report the Compass continues to actively recruit both our Phase 3 country 60 trials in treatment resistant depression with top-line data expected this year and next, while our overall Phase 3 clinical program completion remained on track with top line data from the 006 study expected in the middle of 2025, we are experiencing some recruitment delays interest in the 005 trial, which extends our guidance for top line data from that trial into quarter four of this year.

首先，讓我報告一下，Compass 繼續積極招募我們在治療難治性憂鬱症方面的3 期國家60 項試驗，預計今年和明年將獲得頂線數據，而我們的整體3 期臨床計劃的完成仍按頂線資料步入正軌從預計於 2025 年中期進行的 006 研究開始，我們對 005 試驗的招募出現了一些延遲，這將我們對該試驗的頂線數據的指導延伸至今年第四季度。

Importantly, this change in guidance does not impact expected timing regarding submission of our NDA filing as we've consistently guided, we do expect that both trials will be required for NDA submission, consistent with the FDA draft guidance for the development of psychedelic published in June last year. We will also have all necessary preclinical and clinical pharmacology studies for a complete NDA dossier.

重要的是，這項指南的變化不會影響提交新藥申請的預期時間，正如我們一貫指導的那樣，我們確實預計這兩項試驗都需要提交新藥申請，這與FDA 發布的迷幻藥開髮指南草案一致。去年六月。我們還將進行完整的 NDA 檔案所需的所有必要的臨床前和臨床藥理學研究。

In parallel with the Phase 3 trial program, we continue to take the steps needed to ensure a well-developed delivery network for COMP360, if approved. This includes developing collaborations that will educate both Compass and settings of care on how COMP360 may fit into treatment option for appropriate patients, a key element of these research collaborations is to explore and develop multiple potential commercial delivery campaign to ensure successful rollout of COMP360 treatments subject to FDA approval in different care settings.

在第三階段試驗計畫的同時，如果獲得批准，我們將繼續採取必要的步驟，以確保 COMP360 擁有完善的交付網路。這包括開展合作，讓 Compass 和護理機構了解 COMP360 如何適應適當患者的治療選擇，這些研究合作的一個關鍵要素是探索和開發多個潛在的商業交付活動，以確保成功推出 COMP360 治療主題FDA 在不同護理環境中的批准。

Earlier this quarter, we announced the first two such collaborations with Greenbrook TMS and Hackensack Meridian Health, which are two very different, but equally important collaboration partners. These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COMP360 psilocybin treatments.

本季度早些時候，我們宣布了與 Greenbrook TMS 和 Hackensack Meridian Health 的前兩次此類合作，這是兩個截然不同但同樣重要的合作夥伴。這些合作將探索如何改善病患照護體驗，並更深入了解 COMP360 裸蓋菇素療程的潛在商業模式。

We also expect to announce additional research collaborations this year. In December, we announced initial safety data from our open-label Phase 2 clinical trial of a single 25 milligram dose of COMP360 in 22 people living with post-traumatic stress disorder or PTSD. We were also pleased to see the publication of COMP360 data from an investigator-initiated study in bipolar Type II in JAMA Psychiatry.

我們也預計今年將宣布更多的研究合作。 12 月，我們公佈了開放標籤 2 期臨床試驗的初步安全數據，該試驗對 22 名患有創傷後壓力症候群或 PTSD 的患者進行了單次 25 毫克劑量的 COMP360。我們也很高興看到由研究者發起的一項雙相情感障礙 II 型研究的 COMP360 數據在《JAMA 精神病學》雜誌上發表。

In a moment, Guy will provide more information on both of these study. While PRD is our lead indication for COMP360, we see logical expansion of its utilization into additional indications where there are significant co-morbidities and overlap such as PTSD and bipolar II subject to additional financing.

稍後，蓋伊將提供有關這兩項研究的更多資訊。雖然 PRD 是 COMP360 的主要適應症，但我們認為其用途可以邏輯地擴展至其他適應症，其中存在重大共病和重疊，例如 PTSD 和雙相情感障礙 II，但需要額外融資。

With that, let me now Teri to introduce herself and share a bit about why she came to Compass, Teri?

現在，讓我向 Teri 介紹一下自己，並分享她為什麼來到 Compass，Teri？

Thanks Kabir, now that I'm back at sea level and really happy to be joining you (inaudible) experienced in pioneering leadership team. Similar were many, I sadly witness the impact of mental health issues and people close to me. So big draw for me to the company would be encumbered fully embracing admission with a thoughtful, innovative and data-driven approach to tackling significant unmet need in this area.

謝謝卡比爾，現在我回到了海平面，很高興能加入你們（聽不清楚）經驗豐富的開創性領導團隊。類似的情況還有很多，我悲傷地目睹了心理健康問題和我身邊的人的影響。因此，公司對我的最大吸引力將是完全接受接納，以深思熟慮、創新和數據驅動的方法來解決該領域未滿足的重大需求。

Psychedelics and their potential to treat mental health conditions have received significant attention in the media, but we are still very much just at the beginning of this journey. While Psychedelics could be transformative to mental health in these early days, it is critical for companies to build and execute robust clinical trials planned to realize the long-term potential business precisely the approach Compass have taken with its large Phase 2 ongoing Phase 3 programs in TRD.

迷幻藥及其治療心理健康問題的潛力受到了媒體的廣泛關注，但我們仍處於這段旅程的開始。雖然迷幻藥在早期可能會改變心理健康，但對於公司來說，建立和執行強有力的臨床試驗至關重要，這些臨床試驗計劃實現長期潛在業務，這正是Compass 在其大型2 期正在進行的3 期項目中採取的方法。TRD。

There are a lot of important milestones over the next 12 to 18 months for the company and with a strong balance sheet and an experienced team, we are well positioned for success. I'm really looking forward to working with the team to help shape the landscape and prepare for this potential important treatment option for patients.

公司在未來 12 至 18 個月內將迎來許多重要的里程碑，憑藉強大的資產負債表和經驗豐富的團隊，我們已做好了成功的準備。我真的很期待與團隊合作，幫助塑造景觀並為患者的這一潛在的重要治療選擇做好準備。

With that, let me hand the call back to Kabir.

接下來，讓我將電話轉回給卡比爾。

Many Thanks, Teri. Welcome once again, and it's great to have you join our leadership team. Let me now hand the call over to Guy to update you on clinical units during the quarter. Guy?

非常感謝，泰瑞。再次歡迎您，很高興您加入我們的領導團隊。現在讓我將電話轉交給蓋伊，向您通報本季臨床單位的最新情況。蓋伊？

Thank you Kabir. Looking at the COMP360 pivotal program. Nearly all sites have been initiated to COMP 005 but the 006 trial we have clients initiated in the US, Canada, UK, Ireland, Sweden and Spain. I anticipate further progress this year. Patient demand is strong in all geographies, which, as expected, reflects the degree unmet need in this population.

謝謝卡比爾。看看 COMP360 關鍵計劃。幾乎所有站點都已啟動 COMP 005，但我們的客戶在美國、加拿大、英國、愛爾蘭、瑞典和西班牙啟動了 006 試驗。我預計今年會進一步進展。所有地區的患者需求都很強勁，正如預期的那樣，這反映了該族群需求未滿足的程度。

However, as the (inaudible) we are experiencing delays in recruitment in our 005 trials. As we've said before, these trials are complex beyond the schedule one drug authorizations and unique handling requirements and we're dosing protocol we are formally confirming every patient's TRD diagnosis, an important element to the quality of this program.

然而，由於（聽不清楚）我們 005 試驗的招募工作出現了延誤。正如我們之前所說，這些試驗非常複雜，超出了附表一的藥物授權和獨特的處理要求，我們正在製定劑量方案，正式確認每位患者的 TRD 診斷，這是該計劃質量的重要因素。

This has been a challenge that medical record keeping is decentralized in the US and have slowed the pace of screening and enrolling. However, now that nearly all 005 trials open. And with the addition of resources, we will see an increased pace of recruitment, which should help improve enrollment. The challenges we have encountered are specific to US clinical sites. And as Kabir mentioned, we don't see the same impact to COMP 006 a global trial which remains on track.

在美國，醫療記錄保存的分散化一直是一個挑戰，並且放慢了篩檢和登記的速度。然而，現在幾乎所有005的試驗都開放了。隨著資源的增加，我們將看到招募速度的加快，這將有助於提高入學率。我們遇到的挑戰是美國臨床場所特有的。正如 Kabir 所提到的，我們認為 COMP 006 不會受到同樣的影響，全球試驗仍在進行中。

Separately we are also excited by the potential COMP360 in other indications, PTSD, an additional indication of interest between the investigators in an exploratory Phase 2 safety study of 22 patients, all of whom were administered a single dose of 25 milligrams COMP360 (inaudible) We announced initial safety data in December, which demonstrated that COMP360 was well-tolerated at 24 hours, and the safety profile was as expected, with no treatment emergent serious adverse events reported. The study participants have been followed for 12 weeks, and we look forward to announcing the full PTS dataset, including efficacy later this spring.

另外，我們也對COMP360 在其他適應症（PTSD）中的潛在應用感到興奮，這是研究人員在一項對22 名患者進行的探索性2 期安全性研究中感興趣的另一個適應症，所有患者均接受了單劑量25 毫克的COMP360（聽不清楚）我們去年12月公佈的初步安全性數據顯示，COMP360在24小時內耐受性良好，安全性符合預期，未報告治療中出現的嚴重不良事件。研究參與者已被追蹤 12 週，我們期待在今年春季稍後公佈完整的 PTS 資料集，包括療效。

In addition, as Kabir mentioned the full results from an independent investigator-led study in bipolar type II depression were published in JAMA Psychiatry. These data first announced in 2022 demonstrated the potential for investigational (inaudible) treatments in another difficult to treat depressive disorder. The study was conducted by (inaudible) and Sheppard Pratt in Baltimore and funded by Congress.

此外，正如 Kabir 所提到的，一項獨立研究者主導的 II 型雙相憂鬱症研究的完整結果發表在《JAMA 精神病學》雜誌上。這些數據於 2022 年首次公佈，證明了對另一種難以治療的憂鬱症進行研究性（聽不清楚）治療的潛力。這項研究由（聽不清楚）和謝潑德·普拉特在巴爾的摩進行，並由國會資助。

It investigated the safety and efficacy of a single 25 milligram dose with COMP360 psilocybin treatment with psychological support. The primary endpoint was change in Madras total score from baseline to week three. All 15 participants has lowered Madrics scores with a mean change from baseline of minus 24 points at week three.

它研究了在心理支持下使用 COMP360 裸蓋菇素單次 25 毫克劑量治療的安全性和有效性。主要終點是馬德拉斯總分從基線到第三週的變化。所有 15 名參與者都降低了 Madrics 分數，第三週時與基線相比平均變化為負 24 分。

12 participants met the criteria for response and 11 met the criteria for [remission]. While this is a small trial we see the results as extremely promising. Importantly, there was no increase in the suicidality score based on matters and no unexpected adverse events or difficulties with the dosing sessions over the 12 weeks of the study, we did not see the onset of the manic high-perm and chronic state, which is a particular concern for patients with bipolar disorder.

12 名參與者符合緩解標準，11 名參與者符合[緩解]標準。雖然這是一個小試驗，但我們認為結果非常有希望。重要的是，在研究的 12 週內，自殺傾向評分沒有增加，也沒有意外的不良事件或給藥過程中的困難，我們沒有看到躁狂的高熱情和慢性狀態的發作，這是雙相情感障礙患者特別關心的問題。

The most common adverse event was headache reported by 4 out of 15 participants on the day of dosing with symptoms resolving within 24 hours. People living with bipolar II depression like those living with TRD have limited or no options. So it's encouraging to see early signal that COMP360 psilocybin may have potential to help those living with these depressive conditions.

最常見的不良事件是服藥當天 15 名參與者中有 4 人報告頭痛，症狀在 24 小時內緩解。 II 型雙極性憂鬱症患者（如 TRD 患者）的選擇有限或沒有選擇。因此，令人鼓舞的是看到早期訊號表明 COMP360 裸蓋菇素可能有潛力幫助那些患有這些憂鬱症的人。

As Kabir indicated, based on the studies resolve bipolar Type II looks to be an indication of interest for the use of COMP360 and additional larger studies are under consideration. This is a good fit with our mission of the company.

正如 Kabir 所指出的，根據研究，解決 II 型雙相情感障礙似乎表明人們對使用 COMP360 感興趣，並且正在考慮其他更大規模的研究。這與我們公司的使命非常契合。

Let me now hand the call to Mary Rose for financial overview, Mary Rose?

現在讓我把電話轉給瑪麗羅斯詢問財務概況，瑪麗羅斯？

Thank you Guy. I will now stepped through the full year financial results. Cash used in operations in full year 2023 was $97.4 million within the guidance range we provided for the full year last quarter of $94 million to $100 million excluding R&D tax credits. The timing of receipt of the credit is uncertain, but I'm pleased to confirm the HMRC have since approved our claim and (inaudible) and we now anticipate receiving the tax credit in the first quarter of this year.

謝謝蓋伊。現在我將逐步介紹全年財務表現。 2023 年全年營運中使用的現金為 9,740 萬美元，處於我們上季度為全年 9,400 萬至 1 億美元（不包括研發稅收抵免）提供的指導範圍內。收到稅收抵免的時間尚不確定，但我很高興地確認英國稅務海關總署已批准我們的索賠（聽不清楚），我們現在預計在今年第一季收到稅收抵免。

For the year ended December 31, 2023, net loss was $118.5 million or $2.32 per share compared with a net loss of $91.5 million or $2.16 per share during the same period in 2022. These results include noncash share-based compensation of $17.3 million in 2023 and $13.1 million in 2022. R&D expenses were $87.5 million in 2023 compared to $65.1 million in the prior year. And G&A expenses were $49.4 million in 2023 compared to $45.4 million in prior year. Long-term debt under our hercules loan facility was $28.8 million at the end of fourth quarter.

截至2023年12月31日的年度，淨虧損為1.185億美元，即每股2.32美元，而2022年同期的淨虧損為9150萬美元，即每股2.16美元。這些結果包括2023年1730萬美元的非現金股份補償2022 年研發費用為 1,310 萬美元。2023 年研發費用為 8,750 萬美元，而前一年為 6,510 萬美元。 2023 年的一般管理費用為 4,940 萬美元，而前一年為 4,540 萬美元。截至第四季末，我們大力士貸款融資下的長期債務為 2,880 萬美元。

Regarding first quarter financial guidance, we expect net cash used in operations to be between $17 million and $23 million, which assumes that we received R&D tax credit in the first quarter. However, as I mentioned already, the timing is uncertain.

關於第一季的財務指導，我們預計營運中使用的淨現金將在 1,700 萬美元至 2,300 萬美元之間，假設我們在第一季度獲得了研發稅收抵免。然而，正如我已經提到的，時間是不確定的。

Turning to full year financial guidance, we expect cash used in operations to be between $110 million and $130 million. We expect to narrow this range of the year progresses. Conversely, we need to maintain a strong financial position with cash and cash equivalents of $220.2 million at December 31, 2023, compared Paraguay, $143.2 million at December 31, 2022. We will continue to manage our cash carefully to continue advancing our pivotal program and to achieve important milestones that we believe will create value for our shareholders.

談到全年財務指引，我們預計營運中使用的現金將在 1.1 億至 1.3 億美元之間。我們預計今年的進展範圍將縮小。相反，我們需要維持強勁的財務狀況，截至2023 年12 月31 日的現金和現金等價物為2.202 億美元，而巴拉圭截至2022 年12 月31 日的現金和現金等價物為1.432 億美元。我們將繼續謹慎管理我們的現金，以繼續推進我們的關鍵計劃和實現我們相信將為股東創造價值的重要里程碑。

Thank you, and I'll now turn the call back to Kabir.

謝謝，我現在將電話轉回給卡比爾。

Thank you, Mary Rose, I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both Compass and its area of science. Our COMP360 Phase 3 program remains on track with the first trial expected to readout this year, not only a key milestone for Compass, but also a major event in the development of psychedelic medicine.

謝謝你，瑪麗·羅斯，我很高興我們看到指南針及其科學領域的持續熱情和有意義的勢頭。我們的 COMP360 3 期計畫仍在按計劃進行，首次試驗預計將於今年公佈，這不僅是 Compass 的一個重要里程碑，也是迷幻醫學發展的重大事件。

The FDA draft guidance for clinical studies of psychedelic drugs, along with the European Medicines Agency plans to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe. Our important sign that regulators are preparing for the potential use of psychedelic as treatments.

FDA 起草了迷幻藥物臨床研究指南，歐洲藥品管理局計劃為歐洲迷幻物質的開發和治療使用制定監管指南。我們的重要跡象表明，監管機構正在為迷幻藥作為治療的潛在用途做好準備。

In a sign of the continuing unmet need in TRD, esketamine sold under the brand names, promoter achieved global sales of over $700 million in 2023, which demonstrates the continued growth of interventional psychiatry and the infrastructure to deleverage, which bode well for the potential of COMP360 if approved, we also welcome the news of FDA acceptance of Lighthouse therapeutics NDA submission, the MDNA assisted therapy for PTSD.

TRD 的需求持續未滿足，以品牌名稱銷售的艾氯胺酮，推動者在2023 年實現了超過7 億美元的全球銷售額，這表明介入精神病學和去槓桿化基礎設施的持續增長，這預示著TRD 的潛力。如果 COMP360 獲得批准，我們也歡迎 FDA 接受 Lighthouse Therapeutics NDA 提交的訊息，這是針對 PTSD 的 MDNA 輔助療法。

We're seeing increasing interest from clinicians who plans to incorporate silicide and treatments into their mental health offer our collaborations and indications of this interest. And we'll continue to develop commercial models that enable rapid, scalable road and equitable access to COMP360, if approved.

我們看到臨床醫生越來越感興趣，他們計劃將矽化物和治療納入他們的心理健康，這為我們提供了合作並表明了這種興趣。如果獲得批准，我們將繼續開發商業模型，以實現快速、可擴展的道路和公平訪問 COMP360。

In closing with our strong balance sheet, we are focused on execution of our Phase 3 program in treatment resistant depression. This will be an exciting year for Compass Pathways and we look forward to updating you on our progress over the coming year. Thank you again for your participation on today's call. I will now turn to Q&A.

在我們強大的資產負債表結束之際，我們專注於執行難治性憂鬱症的第三階段計劃。對於 Compass Pathways 來說，今年將是令人興奮的一年，我們期待向您通報我們來年的最新進展。再次感謝您參加今天的電話會議。我現在轉向問答。

So I will hand the call back to the operator (inaudible)

所以我會將電話轉交給接線生（聽不清楚）

Thank you. (Operator Instructions)

謝謝。 （操作員說明）

Patrick Trucchio, H.C. Wainwright.

特魯基奧 (Patrick Trucchio)，H.C.溫賴特。

Thanks. Good morning. Just a couple of follow up questions on the enrollment delays. So the first is just regarding the TRD diagnosis being necessary for enrollment in the program. Can you remind us how you're defining TRD and confirming this diagnosis in patients who are enrolling in the program? And secondly, can you tell us what proportion of patients are expected to have experience with psychedelic?

謝謝。早安.只是關於註冊延遲的幾個後續問題。因此，第一個問題只是關於參加該計劃所需的 TRD 診斷。您能否提醒我們您如何定義 TRD 並在參加該計劃的患者中確認此診斷？其次，您能告訴我們預計有多少比例的患者有迷幻藥的經驗嗎？

Thanks, Patrick. Just checking you can hear us and I'll have to Guy.

謝謝，派崔克。只要檢查一下你聽得到我們的聲音，我就得蓋伊了。

Yeah.

是的。

Hi Patrick yes, I mean, our criteria of those decisions is depression and that means that patients are required to have failed at least two treatments. These treatments have to meet the criteria for adequate dose and adequate duration and the delay that you referred to is caused by the fact that we are being very rigorous in establishing ways that this has occurred through health records and that in the US has proved to be difficult but not impossible and we're proceeding successfully to do that in the patients we are recruiting.

嗨，派崔克，是的，我的意思是，我們做出這些決定的標準是憂鬱症，這意味著患者必須至少經歷過兩次治療失敗。這些治療必須滿足足夠劑量和足夠持續時間的標準，您提到的延遲是由於我們非常嚴格地通過健康記錄確定這種情況發生的方式，並且在美國已被證明是這樣的。這很困難，但並非不可能，我們正在招募的患者中成功地做到了這一點。

I should say there's no shortage of patients, but the issues around verification have been real and that's what caused the problem. The (inaudible) patients who may have been previously taken psychedelics were we've taken that number up from 10% in the Phase 2 to 15% in Phase 3.

我應該說，病人並不缺乏，但驗證方面的問題是真實存在的，這就是造成問題的原因。之前可能服用過迷幻藥的（聽不清楚）患者數量從第 2 階段的 10% 上升到第 3 階段的 15%。

And just to emphasize, one of the issues that we face is that patients conceivably or patient people seeking treatment may be seeking psychedelic. And that's one of the reason why that particularly rigorous insisting on medical records, same proven and (inaudible) Thank you so much.

需要強調的是，我們面臨的問題之一是，可以想像，尋求治療的患者或患者可能正在尋求迷幻藥。這就是為什麼特別嚴格地堅持醫療記錄的原因之一，同樣得到證實並且（聽不清楚）非常感謝。

Got it. If I could just another follow up, I'm just -- I'm wondering if this of just moving that some top-line data back for COMP 3, COMP 005 trial, is that would that have any impact on the potential filing of an NDA for TRD or was the timing kind of going to be unchanged based on the top line data for the 006 trial? And separately, I guess maybe if you could just talk us through what data would be anticipated in the NDA specifically, would you have any certain amount of longer-term follow-up efficacy or safety data from these trials before that NDA is submitted. Thanks so much.

知道了。如果我可以再次跟進，我只是 - 我想知道將一些主要數據移回 COMP 3、COMP 005 試驗是否會對潛在的申請產生任何影響TRD 的NDA 還是根據006 試驗的頂線數據，時間安排會保持不變？另外，我想如果您能具體告訴我們 NDA 中預期的數據，您是否會在提交 NDA 之前從這些試驗中獲得一定數量的長期追蹤療效或安全性數據。非常感謝。

Thanks, Patrick. I'll work backwards from a question. We have now clearly guided on what we again, we expect to including initial submissions that will be available for discussion with the agency. But as a reminder, we have breakthrough designation because clearly it seems like growth submissions as well.

謝謝，派崔克。我將從一個問題開始倒推。我們現在已經明確指導了我們再次希望包括的初步意見，這些意見將可供與該機構進行討論。但提醒一下，我們有突破性的指定，因為顯然它看起來也像是成長提交。

So the first part of the question, no as I said in my prepared remarks, this does not alter the potential timing of our filing 006 remains on track for mid '25, and we have always consistently guided that we do expect both trials we needed to form an adequate (inaudible) we are not anticipating any change in the timing with vendors submission.

所以問題的第一部分，不，正如我在準備好的發言中所說的那樣，這不會改變我們提交006 的潛在時間仍然按計劃在25 年中期進行，並且我們始終一致地指導我們確實期望我們需要的兩項試驗為了形成充分的（聽不清楚），我們預期供應商提交的時間不會有任何變化。

That's helpful. Thank you so much.

這很有幫助。太感謝了。

Thanks, Patrick.

謝謝，派崔克。

Thank you.

謝謝。

Charles Duncan, Cantor.

查爾斯鄧肯，康托爾。

Good morning Kabir and team. Thanks for taking the question. I wanted to follow-up to those last questions. With regard to diagnosis of TRD, can you help us understand how it's different in the United States versus elsewhere? And what percentage of patients are you anticipating in 006? And why will the problem be fixed in that trial, thanks.

早安，卡比爾和他的團隊。感謝您提出問題。我想跟進最後幾個問題。關於 TRD 的診斷，您能幫助我們了解美國與其他地方的診斷有何不同嗎？您預計 006 中的病人比例是多少？為什麼問題會在那次試驗中解決，謝謝。

I mean, I think with the problem in the US, it's basically the nature of the health care system is being simply more decentralized this is in great contrast, really particularly European health care systems, where usually healthcare records are extremely straightforward to access, for example, most patients in the UK have a primary care physician to get health records is simply a matter of contacting the physician with appropriate consent that in the record.

我的意思是，我認為美國的問題基本上是醫療保健系統的本質是更加去中心化，這形成了鮮明的對比，特別是歐洲的醫療保健系統，通常醫療保健記錄非常容易訪問，因為例如，英國的大多數患者都有一位初級保健醫生，只需在獲得記錄中適當同意的情況下聯繫醫生即可獲取健康記錄。

So that is correct that's a tremendous difference from what we have to say (inaudible) I think in terms of the second is about your (multiple speakers) I mean that if you relate, I mean, we think that we will be in a position having set up the systems that we now have to facilitate getting the data that the fact that 006 is taking place subsequent in most centers, 005 means that everything will really be running optimally by the time many of the US sites switch to 006.

所以這是正確的，這與我們要說的有很大不同（聽不清楚）我認為第二個是關於你的（多個發言者）我的意思是，如果你聯繫起來，我的意思是，我們認為我們將處於一個位置在建立了我們現在必須幫助獲取數據的系統之後，006隨後在大多數中心進行，005意味著當許多美國站點切換到006時，一切都將真正以最佳狀態運行。

And the patient centered on in ex US of course, are not subject to the problems anyway. And we think the proportion (inaudible) you also requested it will be about 50, 50. And we can -- when we model it, we think that we're on track. As we said, 006 the problems with 005 really pharmacy do the fact we started 005 first in US.

當然，以美國以外地區為中心的患者無論如何都不會遇到這些問題。我們認為您也要求的比例（聽不清楚）大約是 50、50。我們可以——當我們對其進行建模時，我們認為我們已經步入正軌。正如我們所說，006與005真正藥房的問題確實是我們首先在美國開始005的事實。

That makes sense. If I could ask one follow-up and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also, are you having any challenges with washing patients out before of standard of care, albeit ineffective and depressions before they enter 005?

這就說得通了。如果我可以問一個後續問題，也就是說，如果您正在追蹤螢幕故障率，您能否幫助我們了解螢幕故障率？但話又說回來，在患者進入 005 之前，您在將患者從標準護理中清除出去（儘管效果不佳且患有抑鬱症）方面是否遇到任何挑戰？

I mean their of their factory represents -- the washout represents a challenge, but most of the problem has been the verification of the diagnosis. So that had been 001 of those two drops about a third of the patients in that study were already authentic (inaudible) . So two thirds of washing out and the majority -- great majority were able to do that once they have been enrolled in the study, but it's enrollment (inaudible) the issue in 005.

我的意思是他們的工廠代表——清洗代表了一個挑戰，但大多數問題是診斷的驗證。因此，那是 001 兩滴，研究中大約三分之一的患者已經是真實的（聽不清楚）。因此，三分之二的人被淘汰，而大多數人——絕大多數人在加入研究後就能夠做到這一點，但 005 中的問題是註冊（聽不清楚）。

Got it. Thanks for the added color.

知道了。感謝您添加的顏色。

Thank you.

謝謝。

François Brisebois, Oppenheimer.

弗朗索瓦·布里斯布瓦，奧本海默。

Hi, just a couple here. Just to sorry to ask again about the enrollment, but is the fourth quarter guidance, it's a very conservative or how do we feel comfortable that fourth quarter will be correct for 005?

嗨，這裡只有一對夫婦。只是抱歉再次詢問有關招生的問題，但是第四季度的指導是非常保守的嗎？或者我們如何看待第四季度對 005 來說是正確的？

Thanks Francois, we've been -- we are very comfortable with [Ali], as you would expect that the number of repossessions looked at different scenarios and we are very comfortable with the full quarter guidance.

謝謝弗朗索瓦，我們對[阿里]非常滿意，正如您所期望的那樣，收回的數量考慮了不同的情況，我們對整個季度的指導感到非常滿意。

Okay. And then on the commercial side this bravado infrastructure obviously has some read through here. Can you just remind maybe us the listeners that the House bravado works, how many times people come in?

好的。然後在商業方面，這種虛張聲勢的基礎設施顯然在這裡有一些解讀。你能否提醒我們這些聽眾，眾議院的虛張聲勢是有效的，有多少次人們進來了？

And are there any efficiencies maybe through these centers that what puts you in a situation that might be superior to [provodo]? Just any learnings there? How does that evolve as you guys look into the commercial opportunity?

通過這些中心是否有任何效率可以使您處於可能優於[provodo]的情況？那裡有什麼學習嗎？當你們尋找商業機會時，情況又會如何發展？

It's a great question. So yes, clearly, the protocol for spillover is very different from what we envisaged to be a final protocol for constant basis. So as a reminder, that's provided label actually require eight administrations in the first month for the second month and maintenance that are off to a year patient and physician discretion, but typically every couple of weeks.

這是一個很好的問題。所以，是的，顯然，溢出協議與我們設想的恆定基礎的最終協議非常不同。因此，提醒一下，所提供的標籤實際上需要在第一個月和第二個月進行八次給藥，並在一年內進行維持，由患者和醫生自行決定，但通常每幾週一次。

So you can imagine that over the course of the first three months that something like 12 to 50 sessions, each of those requires the patients in the claim for a minimal really three to four hours given the intranasal administration on the two hours of monitoring and by the way they count driver (inaudible) actually requires a caregiver for each of those as well.

因此，您可以想像，在前三個月的過程中，大約有12 到50 次療程，每次療程都需要索賠中的患者至少三到四個小時，因為在兩個小時的監測中進行了鼻內給藥，並且透過他們計算司機的方式（聽不清楚）實際上也需要每個人都有一名護理人員。

In contrast, obviously, we don't yet know what the durability will be for a (inaudible) typical patient with complete safety from the Phase 3 design relative to address that. But as we've said before, based on what we know, it perhaps might be two to four administrations a year, a patient. So you can see that from a patient perspective, that's a very, very good.

相較之下，顯然，我們還不知道對於一個（聽不清楚）典型患者來說，相對於解決這個問題而言，第三階段設計具有完全安全性，其耐用性如何。但正如我們之前所說，根據我們所知，一名患者一年可能需要接受兩到四次治療。所以你可以看到，從病人的角度來看，這是非常非常好的。

(technical difficulty) is the difference between using one room for a day one separate, perhaps three, four months and actually having multiple uses have grown during the course of time for (inaudible) So we believe and the update the (inaudible) reason we've signed these collaborations with entities such as Greenberg and Hackensack we'll do more is exactly to understand how we are going to integrate sort of size and differentiate from sort of auto into those workflows and how they address with (inaudible)

（技術難度）是一天單獨使用一個房間（可能是三、四個月）與實際上具有多種用途之間的區別隨著時間的推移而增長（聽不清），因此我們相信並更新我們的（聽不清楚）原因已經與Greenberg 和Hackensack 等實體簽署了這些合作協議，我們要做的更多工作就是了解我們將如何將某種規模和差異化的汽車整合到這些工作流程中，以及它們如何解決（聽不清楚）

Great. Thank you very much. Congrats on the progress there.

偉大的。非常感謝。祝賀那裡的進展。

Thank you.

謝謝。

Neena Birtritto Garg, Deutsche Bank.

Neena Birtritto Garg，德意志銀行。

Hi guys, thanks for taking my question. So I just wanted to ask about the enrollment again, and I just wanted to confirm what kind of, if there are any actions that you can take to really maybe accelerate the review that you're doing at confirm diagnosis. Is there anything that you've actually been able to do that you found has been helpful in accelerating that process in the US, thanks

大家好，感謝您提出我的問題。所以我只是想再次詢問有關註冊的問題，我只是想確認一下您可以採取什麼樣的行動，是否可以採取任何行動來加速您在確認診斷時所做的審查。您發現有哪些實際上能夠做的事情有助於加速美國的這一進程，謝謝

Yes, worth that have and we've taken those mitigating actions. So we have added specific vendors to our able with patient consent to work directly with patients and to obtain medical records what we have seen it. But that does enable us certainly in some circumstances for (inaudible) records much more quickly than we are going through the motions ourselves or without (inaudible) actually have added specific paid for vendors on a couple of different ones, in fact to enable that (inaudible)

是的，這是值得的，我們已經採取了這些緩解措施。因此，我們在患者同意的情況下增加了特定的供應商，以便能夠直接與患者合作並獲取我們所看到的醫療記錄。但這確實使我們在某些​​情況下（聽不清楚）記錄比我們自己走動要快得多，或者沒有（聽不清楚）實際上已經為幾個不同的供應商添加了特定的付費，事實上是為了實現這一點（聽不見）

Okay, got it. Thank you. That's helpful.

好，知道了。謝謝。這很有幫助。

Thank you.

謝謝。

Ritu Baral, TD Cowen.

裡圖·巴拉爾，TD·考恩。

Good morning, guys. Thanks for taking the question. Because are you anticipating that this delay and this sort of going back and reconfirming TRD is going to chang the patient demographic in any way, shape or form? Is that sort of coming out different than how might that affect the potential powering or potential perceived expected placebo effect in the study? And the follow-up to that is, have you determine what you are going to release with top line data at the end of the year, specifically longer-term follow-up and durability. And then just a follow-up on the centers.

早上好傢伙。感謝您提出問題。因為您是否預計這種延遲以及這種返回並重新確認 TRD 將以任何方式、形狀或形式改變患者人口統計？這種結果與研究中潛在的動力或潛在的預期安慰劑效應的影響有何不同？後續行動是，您是否確定了年底將發布哪些頂線數據，特別是長期跟進和持久性。然後是對中心的後續行動。

So let me start, but I'll also ask (inaudible) the first part of the question. So to be clear, this does not in any way represent a change to the inclusion criteria nor impact is this a change from what we needed to do in Phase 2B, but a couple of things to avoid adverse. Obviously, the Phase 2B was only partly in the US that was ultimately a global study.

讓我開始，但我也會問（聽不清楚）問題的第一部分。因此需要明確的是，這絕不代表對納入標準的改變，也不影響我們在第 2B 階段需要做的事情，而是要避免一些不利的事情。顯然，2B 階段僅部分在美國進行，最終是一項全球研究。

Second, I think we do think it's relevant that Phase 2B 001 and 006 have three doses of active, one tenant, 25, whereas as 005, there is a real placebo and clearly from a patient willingness or patient incentive to enroll, that is a significant difference between 005 and 001 and 006. So Guy, if you want to add anything on that?

其次，我認為我們確實認為2B 期001 和006 階段有三劑活性藥物，一個租戶，25 劑，而作為005，有一個真正的安慰劑，並且顯然從患者參加的意願或患者激勵來看，這是相關的005、001 和 006 之間存在顯著差異。那麼蓋伊，您是否想對此添加任何內容？

I don't think that they're trying to renegotiate the vendors that we hired was that because this is a general problem isn't just a problem, our definition hasn't changed. And so our considerations around power placebo response are unchanged as well. So it's just the delay. And we think we've overcome some of the factors that contributed to it now.

我不認為他們試圖與我們僱用的供應商重新談判，因為這是一個普遍問題，而不僅僅是一個問題，我們的定義沒有改變。因此，我們對強效安慰劑反應的考量也沒有改變。所以這只是延遲。我們認為我們現在已經克服了一些導致這種情況的因素。

And for the second part of the question of retail, as you're very well aware, this is a blinded trial through Part B through 26 weeks. And therefore, determining what we will be able to announce with top line and something that will be another review at that time.

對於零售問題的第二部分，正如您非常清楚的那樣，這是一個為期 26 週的 B 部分盲試驗。因此，確定我們將能夠在頂線宣布什麼以及屆時將進行另一次審查的內容。

Got it. And then a follow-up question, you mentioned multiple delivery translates when you speak of your collaborations with Greenbrook and Hackensack, and you mentioned that you're working through options. Are there any sort of buckets different tin plate or particular aspects of delivery is that you are, I guess, building out and investigating with those issue. it's sort of like just large phenotype with different phenotypes of delivery models that we should be thinking about at this point?

知道了。然後是一個後續問題，當您談到與格林布魯克和哈肯薩克的合作時，您提到了多重交付翻譯，並且您提到您正在研究各種選擇。我猜您正在建造並調查這些問題，是否有任何類型的不同馬口鐵或交付的特定方面的桶。這有點像我們現在應該考慮的不同表型的遞送模型的大表型？

It's a great question. And what I would say, what we're doing is precisely to understand how many different phenotypes of delivery shall we say that we're going to be. And so if we take the first two of three Greenbrook and Hackensack side, a very good with Greenbrook is a core profit. network of international psychiatry centers that is essentially today operating came as kind of a proviso, but are interested in operating psychedelic as well.

這是一個很好的問題。我想說的是，我們正在做的正是為了了解我們將有多少種不同的交付表型。因此，如果我們採取格林布魯克和哈肯薩克三支球隊中的前兩名，那麼格林布魯克的出色表現就是核心利潤。目前正在運作的國際精神科中心網絡只是一種附帶條件，但也對經營迷幻藥感興趣。

But only got recently branched into establish a more traditional psychiatric treatments and therefore, how this will fit. They already have physical infrastructure for the delivery of these things. So working out what works for them in that context, may be very different from somebody like Hackensack, which is an integrated regional health system with multiple sites that currently have different specialisms.

但直到最近才開始建立更傳統的精神科治療方法，因此，這將如何適合。他們已經擁有用於交付這些東西的實體基礎設施。因此，在這種情況下找出對他們有效的方法可能與像哈肯薩克這樣的人有很大不同，哈肯薩克是一個綜合的區域健康系統，擁有多個站點，目前有不同的專業。

But also thanks to a very large kind of tertiary care center for 300 beds, which we're probably going to be at the heart of where they will treat psychedelic. So I think the reason we are doing is that the reason we will see a couple of more collaborations again and very different settings of care is exactly because we learn what's sort of different delivery models of (inaudible)

但也要感謝一個擁有 300 個床位的大型三級護理中心，我們可能會成為他們治療迷幻藥的中心。所以我認為我們這樣做的原因是我們會再次看到更多的合作和非常不同的護理環境正是因為我們了解了（聽不清楚）的不同交付模式

And I would extend also to remember, for instance, you can imagine some commercial lenders might be very open to buy and build that may actually fits very well with their economics and offer an attractive group, health systems and so it's much more likely to be half the wells and (inaudible) the peak of the questions (inaudible)

我還要記住，例如，你可以想像一些商業貸款人可能非常願意購買和建造，實際上可能非常適合他們的經濟，並提供有吸引力的群體和衛生系統，因此更有可能一半的井和（聽不清楚）問題的高峰（聽不清楚）

Got it. So each collaboration is going to represent a type of setting that is -- that has significant fees in the US or is that the way to think about each of these individual collaboration?

知道了。因此，每一次合作都將代表在美國收取大量費用的環境，或者這是考慮每一次單獨合作的方式？

The way to think about it as they also deliver. Obviously, there's a limit to the number we can do like very pre-commercial setting. And yes, they are designed to be sufficiently different that they have, as we say, allow us to develop [10 sites], put them in kind of where we get to full pre-launch activities that we're lucky enough to get that we can then take those handbags and other examples of these similar settings and at that point in time (inaudible)

他們也提供了思考的方式。顯然，我們可以做的數量是有限的，就像非常預先商業化的環境一樣。是的，它們的設計足夠不同，正如我們所說，它們允許我們開發 [10 個站點]，將它們放在我們可以進行全面的啟動前活動的地方，我們很幸運能夠得到這些然後我們可以在那個時間點採取這些手提包和其他類似設置的例子（聽不清楚）

Understand. thanks for taking the questions.

理解。感謝您提出問題。

Thank you.

謝謝。

Sumant Kulkarni, Canaccord Genuity.

蘇曼特‧庫爾卡尼 (Sumant Kulkarni)，Canaccord Genuity。

Good morning (inaudible) to the team. I'll add my welcome to Teri. It's great to work with you again. Thanks for taking my questions. The question is actually the additional indications for COMP360. You've mentioned PTSD and depression and back to bipolar disorder. But is there a reason why you have not specifically mentioned anxiety, especially given co-morbid depression?

團隊早安（聽不清楚）。我將對泰瑞表示歡迎。很高興再次與您合作。感謝您回答我的問題。問題實際上是COMP360的附加適應症。您提到了創傷後壓力症候群（PTSD）和憂鬱症，然後又回到雙相情感障礙。但您沒有具體提到焦慮，特別是考慮到共病憂鬱症，有什麼原因嗎？

And are you collecting any anxiety related measures in your Phase 3 program? And just a bit of a follow on to that, how closely are you watching a potential competitor in (inaudible) program with (inaudible) that reported Phase 2 data yesterday?

您在第三階段計畫中是否收集了任何與焦慮相關的措施？接下來，您對昨天報告第二階段數據的（聽不清楚）計劃中的潛在競爭對手的關注程度如何？

Yeah, thanks Sumant, great question. I mean there's a tremendous need a shared genetic origins for depression anxiety. And so they're closely related and most patients with depression have embarked need levels, at least to some degree. We are, as you are including anxiety measures, specifically the GIDs that wasn't in our trials we did in 001, we published data on that already.

是的，謝謝蘇曼特，很好的問題。我的意思是，憂鬱焦慮症非常需要共同的遺傳起源。因此，它們是密切相關的，大多數憂鬱症患者至少在某種程度上已經達到了需求水準。正如您所納入的焦慮測量，特別是我們在 001 中所做的試驗中未包含的 GID，我們已經發布了相關數據。

So we certainly see an (inaudible) then at the enzyme in a realistic potential will COMP360. But in many ways, the presentation of anxiety is usually in primary care, and we can't really see how COMP360 would be kind of the short treatment of choice under those circumstances.

因此，我們當然會看到（聽不清楚）酵素的現實潛力將是 COMP360。但在許多方面，焦慮症的表現通常是在初級保健中，我們無法真正看出 COMP360 在這種情況下如何成為短期治療選擇。

And for that reason, we have not done for that in the first instance. But clearly, patients who have both depression and anxiety are probably the commonest phenotype around. And we think that there will be an advantage in treating that population on the basis of their depressive symptoms but it's potentially treating their enzyme.

出於這個原因，我們一開始就沒有這樣做。但顯然，同時患有憂鬱症和焦慮症的患者可能是最常見的表型。我們認為，根據憂鬱症狀來治療該族群將會有優勢，但它可能會治療他們的酵素。

And Guy what do you want to comment on the competitive difference?

蓋伊，您對競爭差異有何評論？

That's early-stage (inaudible) and obviously aware of this, and it's a relatively small study in Australia and to the patients, as I recall, but alos yes acknowledge that was published yesterday and somebody that we will begin soon (inaudible)

這是早期階段（聽不清楚），顯然意識到了這一點，據我記得，這是在澳洲和對患者而言相對較小的研究，但也承認昨天發表了這一點，我們很快就會開始（聽不清楚）

Okay. The logistical hurdles in the US that are leading to the slight delay, contribute to a meaningful change in the financial outlay required for 005 and 006?

好的。美國的後勤障礙導致了 005 和 006 所需的財務支出發生了有意義的變化？

(inaudible) made some additional investments. And that will be, I would say that non-material change, into the extent of '25.

（聽不清楚）進行了一些額外的投資。我想說，這將是非物質性的變化，達到 25 年的程度。

Thank you.

謝謝。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Hey, guys. This is Michael Okunewitch on the line. Thank you for taking my questions today. So I guess to start off, I'd like to ask are you using a more rigorous verification of the TRD diagnosis compared to the Phase 2B? And if so, what is the reason that this has to do with greater public awareness of psychedelic and their efficacy or just a factor of a larger US portion for the study.

大家好。我是邁克爾·奧庫內維奇。感謝您今天回答我的問題。所以我想首先我想問一下，與 2B 階段相比，你們是否對 TRD 診斷使用了更嚴格的驗證？如果是這樣，這與大眾對迷幻藥及其功效的更大認識有關，或者只是美國參與研究的一個因素。

So no, we're not exactly the same inclusion criteria is the same population. It is (inaudible) enough to another question that is populated with (inaudible) , a 100% US and also anything the nature of the arms of the study being true placebo as opposed to both 001 and 006 that have three doses of active drug. I think that also the contributing factor.

所以不，我們的納入標準並不完全相同，也就是同一群體。對於另一個充滿（聽不清楚）的問題來說，這（聽不清楚）已經足夠了，100% 美國以及該研究的任何性質都是真正的安慰劑，而不是001 和006 都含有三種劑量的活性藥物。我認為這也是促成因素。

All right. Thank you. And then just one for me I just wanted to see how closely you would be watching the lifecos NDA process and potential subsequent approval. Is there anything in particular that you're looking for on the commercial or reimbursement side that may help to inform your strategy for COMP360?

好的。謝謝。對我來說，我只是想看看你們會多麼密切地關注 lifecos NDA 流程和潛在的後續批准。您在商業或報銷方面有什麼特別需要尋找的東西可以幫助您制定 COMP360 策略嗎？

So yes, we will clearly be observing the regulatory process for Lycos very closely, we wish them well and I think it's clearly premature to CEO how that thinking through commercial reimbursement. But obviously, we recognize that there will be lessons from that progress, both through the regulatory and commercial and Phases for us.

所以，是的，我們顯然會非常密切地觀察 Lycos 的監管流程，我們祝他們一切順利，我認為執行長如何考慮商業報銷顯然還為時過早。但顯然，我們認識到，我們將從監管和商業階段的進展中學習。

Right. Thank you very much.

正確的。非常感謝。

Thank you.

謝謝。

Elemer Piros, Rodman & Renshaw.

埃萊默·皮羅斯、羅德曼和倫肖。

Yes, good morning. I don't have a question related to the delay. But I have a question about back (inaudible) indication was mentioned that view or not focusing on it necessarily. Would you be interested in licensing COMP360 to indications that or potentially no interest to you?

是的，早安。我沒有關於延遲的問題。但我有一個關於後面（聽不清楚）指示的問題，提到了該觀點或不一定關注它。您是否有興趣將 COMP360 授權給您有興趣或可能沒有興趣的跡象？

Thank you Elemer and congratulations on the new gig. That's an interesting question what I will say that in general, split indications are enormously challenging in my experience if you could particularly if you can't clearly identify a very different dosing paradigm. So that's not something we have given any great consideration to clearly, if somebody came with a very compelling proposal, we would listen to it, but it's not in general, it's pretty hard with a stable margin (inaudible)

謝謝 Elemer，並祝賀你的新演出。這是一個有趣的問題，我要說的是，一般來說，根據我的經驗，如果你可以，特別是如果你不能清楚地識別一種非常不同的劑量範式，那麼分割適應症是巨大的挑戰。因此，這不是我們明確考慮的事情，如果有人提出了一個非常引人注目的提案，我們會聽取它，但這不是一般情況，有穩定的利潤是相當困難的（聽不清楚）

Thank you. Thank you very much, Kabir.

謝謝。非常感謝你，卡比爾。

Thank you. There are no further questions at this time. I'd like to hand the call back over to management for any closing remarks.

謝謝。目前沒有其他問題。我想將電話轉回管理層以供結束語。

Thanks, everyone for joining in conclusion, let me just say again, our guidance for the overall timing of our Phase 3 program in TRD is unchanged. We are acknowledging or giving guidance around the slight delay into quarter four '24 of top-line data from 005 for our overall guidance remains unchanged.

謝謝大家參與總結，讓我再說一遍，我們對 TRD 第三階段計畫整體時間安排的指導沒有改變。我們承認或就 005 年的頂線數據略有延遲到 24 年第四季提供指導，因為我們的整體指導保持不變。

We continue to be very focused on execution in TRD and also as we said continuing to think about which other indications of interest would be the most compelling (inaudible) to take completely in that. So thanks very much, everyone. Thank you for your time and attention today.

我們繼續非常關注 TRD 的執行，正如我們所說，繼續思考哪些其他興趣跡象將是最引人注目的（聽不清楚）完全接受。非常感謝大家。感謝您今天的時間和關注。

Thank you for your participation. This does conclude the program. You may all disconnect. Everyone, have a great day.

感謝您的參與。這確實結束了該程式。你們都可以斷開連線。大家，祝你有美好的一天。