Compass Pathways PLC (CMPS) 2024 Q3 法說會逐字稿

Thank you for standing by. My name is Loella, and I will be your conference operator today. At this time. I would like to welcome everyone to the compass pathways. Third quarter, 2024 investor call. All lines have been placed on mute to prevent any background noise.

謝謝你的支持。我叫洛埃拉，今天我將擔任你們的會議操作員。此時。我歡迎大家來到指南針之路。2024 年第三季投資者電話會議。所有線路均已靜音，以防止任何背景噪音。

After the speaker's remarks, there will be a question in and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you.

演講者發言後，將進行問答環節。如果您想在此期間提問，只需按電話鍵盤上的星號，然後再按數字 1 即可。如果您想撤回問題，請再按星號一。謝謝。

I would now like to turn the call over to Steve Schultz, senior Vice President of Investor Relations. Please go ahead.

我現在想將電話轉給投資者關係高級副總裁史蒂夫舒爾茨 (Steve Schultz)。請繼續。

Welcome all of you and thank you for joining us today for our third quarter, 2024 results 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, Lori Englebert, our Chief Commercial Officer and Teri Loxam, our Chief Financial Officer who will be giving prepared remarks as well as Dr Guy Goodwin, our Chief Medical Officer and Dr Mike Gold our chief R&D officer who will join us for Q&A 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.

歡迎大家，感謝您今天再次參加我們的 2024 年第三季業績電話會議。我叫 Steve Schultz，Compass Pathways 投資人關係資深副總裁。今天，我們的執行長 Kabir Nath、我們的首席商務官 Lori Englebert、我們的財務長 Teri Loxam 以及我們的首席醫療官 Guy Goodwin 博士和 Mike 博士將發表事先準備好的演講。 Gold 將與我們一起進行問答，此次電話會議正在錄音，並將在電話會議結束後不久在Compass Paths 和投資者關係網站上發布，並將在我們開始之前的30 天內提供。

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 1,995. 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 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.

讓我提醒大家，在今天的電話會議中，團隊將做出 1,995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。經修訂，您不應過度依賴這些前瞻性陳述，由於各種風險、不確定性和其他因素（包括這些風險和不確定性），實際事件或結果可能與任何前瞻性陳述明示或暗示的內容存在重大差異在風險因素標題下進行了描述。在我們向美國證券交易委員會提交的最新 10-Q 表格季度報告以及 compass 向 SEC 提交的後續文件中。

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

此外，這些前瞻性陳述僅代表我們今天的觀點，不應被視為代表我們在任何後續日期的觀點。我們特別聲明不承擔更新或修改任何前瞻性聲明的義務，即使我們的估計或假設發生變化，我現在將把電話轉交給 Kabir Nath。

Thank you, Steve. Good day everyone and thank you for joining us.

謝謝你，史蒂夫。大家好，感謝您加入我們。

Let me begin by welcoming Lori to her first quarterly.

首先讓我歡迎 Lori 來到她的第一季。

Call with Compass. As I said on our August call, we're pleased to have such an exceptional leader, join the company and round out our executive team. Lori brings deep strategic and commercial experience having most recently launched or (inaudible), that experience will be valuable as we prepare for the commercialization of comp 360. And we're thrilled that she has joined us.

用指南針打電話。正如我在八月的電話會議上所說，我們很高興有這樣一位傑出的領導者加入公司並完善我們的管理團隊。Lori 在最近推出或（聽不清楚）方面帶來了深厚的策略和商業經驗，當我們為 comp 360 的商業化做準備時，這些經驗將非常有價值。我們很高興她加入我們。

In a moment I'll ask Laurie to update you on the commercial landscape and our commercial preparation, which we know are areas of major interest and focus for our investors. And as usual, Teri will provide you with a financial update.

稍後我將請勞裡向您介紹商業前景和我們的商業準備工作的最新情況，我們知道這是我們投資者主要感興趣和關注的領域。和往常一樣，泰瑞將為您提供最新的財務資訊。

First though I want to address questions around the anticipated disclosure of our pivotal comp 360 trials on our August earnings call. We pushed the anticipated six-week disclosure date for the comp 005 trial back to the end of this year or early next year.

首先，我想在 8 月的財報電話會議上回答有關我們關鍵的 comp 360 試驗的預期披露的問題。我們將 comp 005 試驗預計為期六週的揭露日期延後到今年底或明年初。

Based on our recruitment to date, I now look unlikely that we will be able to disclose the six-week data in the first quarter. And we're therefore updating our guidance for the six-week 005 data to the second Quarter of 2025 to give us more assurance.

根據我們迄今為止的招聘情況，我現在看起來不太可能披露第一季的六週數據。因此，我們將 6 週 005 數據的指導更新至 2025 年第二季度，以便給我們更多的保證。

Our top priority is completing our phase three trials and we're doing everything we can to ensure that sites recruit as quickly as possible while maintaining the integrity and quality of the trial.

我們的首要任務是完成第三階段試驗，我們正在盡一切努力確保站點盡快招募人員，同時保持試驗的完整性和品質。

Mike Gold who came on board in May has significant drug development experience in neuroscience and is spending much of his time on the ground with the sites which has given us new insights into some of the challenges and helped us to refine our plans.

五月加入的 Mike Gold 在神經科學領域擁有豐富的藥物開發經驗，他將大部分時間花在現場工作上，這讓我們對一些挑戰有了新的見解，並幫助我們完善了計劃。

We're the first company to conduct such large psychedelic trials.

我們是第一家進行如此大規模迷幻試驗的公司。

And we did not have the benefit of prior comparable phase three timelines to base our assumptions on our phase three enrollment projections were based on the phase 2B enrollment curve. And while we did factor in some new aspects of the phase three trials into our projections, there have been a number of items related to the complexity of the trials that we're now learning along the way.

我們沒有利用先前可比較的第三階段時間表的優勢來根據我們基於 2B 階段註冊曲線的第三階段註冊預測進行假設。雖然我們確實將第三階段試驗的一些新方面納入了我們的預測，但我們現在正在了解許多與試驗的複雜性相關的項目。

The phase 2B was a simpler protocol with all active arms, a single dose and blinded for just 12 weeks, comp 005. On the other hand, is a 52 week trial blinded for the 1st 26 weeks and has multiple parts where additional doses can be given, which significantly increases the logistical complexity for sites to schedule patients and therapists as well as for patients themselves.

2B 期是更簡單的方案，所有活性組別均採用單一劑量，盲法僅 12 週，比較 005。另一方面，這是一項為期52 週的試驗，第一個26 週是盲法，並且有多個部分可以給予額外劑量，這顯著增加了站點安排患者和治療師以及患者本身的後勤複雜性。

These complexities are specific to the clinical trial setting but have resulted in inexperienced sites carefully managing patient flow as they become more proficient.

這些複雜性是臨床試驗環境所特有的，但導致缺乏經驗的站點在變得更加熟練時仔細管理患者流程。

Mike and his team are paying close attention to the needs of each site and are providing the necessary resources to support them on a case-by-case basis.

麥克和他的團隊密切注意每個站點的需求，並根據具體情況提供必要的資源來支援它們。

This hands-on approach is working, and we'll be continuing to dedicate all our focus to successfully completing these trials.

這種實踐方法正在發揮作用，我們將繼續全力以赴成功完成這些試驗。

There continues to be significant demand from patients at the top of the funnel and it's a matter of blocking and tackling and helping sites get patients through the process as quickly as possible.

漏斗頂部的患者仍然有大量需求，這是一個阻止和解決並幫助網站盡快讓患者完成整個過程的問題。

Beyond timing for the trial, we're also frequently asked what data we will be disclosing with the 0056 week data readout.

除了試驗時間之外，我們還經常被問到我們將在 0056 週數據讀出時披露哪些數據。

Please remember that while the primary endpoint is at six weeks, the trial remains ongoing and blinded through 26 weeks.

請記住，雖然主要終點是在六週時，但試驗仍在進行中，並且在 26 週內採用盲法。

Therefore, we're going to be limited in what we can release at six weeks so that we maintain the integrity of blinding as much as possible.

因此，我們將限制六週內發布的內容，以便盡可能保持盲法的完整性。

We will disclose three key efficacy measures for the six-week endpoint, the madras effect difference between the arms key value and confidence intervals.

我們將揭露六週終點的三個關鍵療效指標、各組關鍵值和置信區間之間的馬德拉斯效應差異。

We believe that these data should provide investors with a clear understanding of the treatment effect and if positive provide an important validation of the positive phase two be treatment result from a safety standpoint. We provide a high-level assessment for the independent DSMB which looks at unblinded data on a regular basis to monitor safety risks for patients in the trial.

我們認為，這些數據應該讓投資人對治療效果有一個清晰的了解，如果是正面的，則從安全的角度來看，可以對第二階段治療的正面結果提供重要的驗證。我們為獨立的 DSMB 提供高水準評估，該評估定期查看非盲數據，以監控試驗中患者的安全風險。

Suicidality is an inherent feature of TRD, and suicidal ideation is expected in this population as part of the DSNB assessment at the time of the data readout. They will also comment on whether they're seeing any imbalance in suicidal ideation.

自殺是 TRD 的固有特徵，在數據讀出時，作為 DSNB 評估的一部分，預計該族群會出現自殺意念。他們也將評論他們是否發現自殺意念有任何不平衡。

At this six-week endpoint, we will not be able to provide secondary endpoints or Indepth safety tables as that would require further unblinding.

在這個六週終點，我們將無法提供次要終點或深入安全表，因為這需要進一步揭盲。

Let me now turn to the comp 006 trial, which is our second phase three trial as a reminder, 006 has three active dose arms of 1 mg, 10 mg and 25 mg with the same three-part structure as 005 with the primary endpoint at the end of part A at six weeks. A fully blinded part B through 26 weeks and an open label part C through 52 weeks. In the 006 trial, each participant gets two doses of comp 360 3 weeks apart at the start of the trial, the recent LYCOS outcome and the fact that they received a complete response letter provided key insights into the FDA' S thinking on some of the challenges faced by this new class of drugs.

現在讓我談談comp 006 試驗，這是我們的第二個三期試驗，提醒一下，006 具有1 mg、10 mg 和25 mg 三個活性劑量臂，具有與005 相同的三部分結構，主要終點為A 部分在六週時結束。完全盲法 B 部分持續 26 週，開放標籤 C 部分持續 52 週。在 006 試驗中，每位參與者在試驗開始時間隔 3 週服用兩劑 comp 360，最近的 LYCOS 結果以及他們收到完整回复信的事實為 FDA 對某些問題的思考提供了重要見解。新藥面臨的挑戰。

While most of the FDA and ADCOM concerns were specific to LYCOS and their MD MA assisted therapy program, there was a high degree of scrutiny regarding.

雖然 FDA 和 ADCOM 的大部分擔憂都針對 LYCOS 及其 MD MA 輔助治療計劃，但對此進行了高度的審查。

Unblinding, which is very relevant to our studies.

揭盲，這與我們的研究非常相關。

While both the 005 and 006 trials are blinded to 26 weeks. The 006 trial with its three active arms is designed to minimize the risk of unblinding. As participants know they will receive a dose of com 360 with a 15% cap on recruitment of patients with prior psychedelic drug experience.

而005和006的試驗都是26週的盲法。006 試驗有三個主動臂，旨在最大限度地降低揭盲風險。參與者知道，他們將接受一劑 com 360，招募有迷幻藥物經驗的患者時有 15% 的上限。

It will be difficult for the overwhelmingly psychedelic naive participants to determine which dose they received particularly between the 10 and 25 mg doses, which is what we saw with the overlapping responses between 10 and 25 mg in our phase 2B trial, we believe that this is an effective strategy to maintain blinding and given the importance of the 006 trial for compass to gain valuable regulatory and commercial insights around redosing and durability. We want to ensure that we preserve that through the blinded portion of the trial.

對於絕大多數迷幻天真的參與者來說，很難確定他們接受了哪種劑量，特別是在10 至25 毫克劑量之間，這就是我們在2B 期試驗中看到的10 至25 毫克之間的重疊反應，我們相信這是考慮到指南針 006 試驗的重要性，這是一種保持致盲的有效策略，以獲得有關重劑量和耐久性的寶貴監管和商業見解。我們希望確保在試驗的盲法部分中保留這一點。

We therefore made the very difficult decision to further protect the blinding of the 006 trial and only release data after the 26 week time point has been reached for all patients while recruitment for 006 has been going well so far at the sites that are up and running, we're still working through some site initiations in Europe, some of which have taken longer than projected. And we're also relying on a number of the US sites from 005 to roll over to 006.

因此，我們做出了非常困難的決定，以進一步保護006 試驗的盲法，並且僅在所有患者達到26 週時間點後才發布數據，而006 的招募到目前為止在已啟動和運行的站點進展順利，我們仍在歐洲進行一些站點啟動工作，其中一些花費的時間比預計的要長。我們也依賴一些美國網站從 005 過渡到 006。

Therefore, taking into consideration the shift of disclosure to the 26-week time points for 006 as well as potential unpredictability and recruitment. We now expect to disclose data for 006 in the second half of 2026.

因此，考慮到006的揭露時間點移至26週以及潛在的不可預測性和招募。我們現在預計將在 2026 年下半年揭露 006 的數據。

While we have a better understanding of the variables impacting enrollment, we're continuing to actively consider all other opportunities to accelerate this trial.

雖然我們對影響註冊的變數有了更好的了解，但我們仍在積極考慮所有其他機會來加速這項試驗。

We remain fully confident in the potential impact psilocybin can have for patients. We want to do everything we can to ensure a successful development and regulatory outcome for comp 360. And we believe that these steps give us the best chance in parallel to optimizing our regulatory strategy. We're also focused on building a robust commercial strategy and adequately preparing the market for a potential paradigm changing treatment. And that's where Lori is focused. I'll now turn it over to her to go through some of the observations since joining.

我們對裸蓋菇素對患者的潛在影響仍然充滿信心。我們希望盡一切努力確保 comp 360 的成功開發和監管結果。我們相信，這些步驟為我們提供了優化監管策略的最佳機會。我們也致力於建立強大的商業策略，並為潛在的改變治療模式的市場做好充分準備。這就是洛瑞的焦點。現在我將把它交給她，讓她回顧加入以來的一些觀察。

Thank you, Kabir.

謝謝你，卡比爾。

Let me begin by saying what a privilege it is to be part of the compass pathways. Team.

首先我要說的是，成為羅盤路徑的一部分是多麼榮幸。團隊。

Our focus on advancing treatment options for patients with difficult to treat mental health conditions, especially for patients with treatment resistant depression or TRD is an area I have a personal connection to and I am extremely passionate about helping deliver potential solutions for patients and their providers.

我們專注於為患有難以治療的心理健康問題的患者提供治療方案，特別是針對難治性抑鬱症或TRD 患者，這是我個人有聯繫的一個領域，我非常熱衷於幫助患者及其提供者提供潛在的解決方案。

By definition, treatment resistant depression is an area of extremely high unmet need.

根據定義，難治性憂鬱症是一個需求未被滿足的極高領域。

About third of patients treated for major depressive disorder fail to achieve remission after two therapies and are therefore considered treatment resistant innovation and commitment to develop safe and effective products in this patient population has been limited and currently there are only two FDA approved pharmacologic treatments with a TRD indication if approved comp 360 has the potential to change the way patients who are suffering from treatment resistant depression are managed and given the high unmet need in this patient population, we see significant commercial opportunity.

大約三分之一的重度憂鬱症患者在兩種療法後未能獲得緩解，因此被認為是治療抗藥性創新，並且在這一患者群體中開發安全有效產品的承諾受到限制，目前只有兩種FDA 核准的藥物治療方法TRD 適應症如果核准的 comp 360 有可能改變治療難治性憂鬱症患者的治療方式，並且鑑於該患者群體的需求未得到滿足，我們看到了巨大的商業機會。

As I have been diving in at compass, I have been impressed by the many facets of the commercial work that are already underway.

當我深入研究 Compass 時，已經在進行的商業工作的許多方面給我留下了深刻的印象。

All important steps forward in preparing for launch success.

為發射成功做準備的所有重要步驟。

These areas include ensuring appropriate billing codes are established to align with our administration model.

這些領域包括確保建立適當的計費代碼以與我們的管理模型保持一致。

Preparing states for DEA rescheduling KOL interactions and investing in health economics research to prepare for future payer discussions.

讓各州為 DEA 重新安排 KOL 互動做好準備，並投資於衛生經濟學研究，為未來的付款人討論做好準備。

One additional area of important work is our bidirectional learning through strategic collaborations with select interventional psychiatry networks.

另一個重要工作領域是我們透過與選定的介入精神醫學網絡進行策略合作進行雙向學習。

Through these collaborations, we have the opportunity to gain insights and learn from providers in various care settings within the delivery centers.

透過這些合作，我們有機會獲得見解並向分娩中心內各種護理環境中的提供者學習。

Some of the key learnings include understanding current operating models, how they have adapted to support bravado and working with the sites to identify opportunities to scale the comp 360 operating model.

一些關鍵的學習內容包括了解當前的營運模式、它們如何適應以支持虛張聲勢，以及與網站合作以確定擴展 comp 360 營運模式的機會。

Ultimately, we want to use the learnings from our collaborations to make sure that delivery centers can fit comp 360 into their current operating infrastructure launch and are prepared to support what we expect will be significant demand for a new and novel treatment beyond today's current treatment options, an area of consistent feedback as we as we have been out in discussions with HGPS over the past year is just how much enthusiasm there is for the potential of comp 360 how much providers want to be ready for it.

最終，我們希望利用我們合作中的經驗教訓，確保交付中心能夠將 comp 360 融入其當前的運營基礎設施啟動中，並準備好滿足我們預期對超越當今當前治療方案的新型治療的巨大需求在過去的一年裡，我們與HGPS 進行討論時得到的一致反饋是，人們對comp 360 的潛力有多大的熱情，有多少提供者希望為此做好準備。

One key question which investors have as well is whether the Interventional psychiatry network is capable of managing sufficient demand for comp 360 at scale and how delivery centers will handle the monitoring time required.

投資者還面臨的一個關鍵問題是，介入精神病學網絡是否能夠大規模管理對 comp 360 的足夠需求，以及交付中心將如何處理所需的監測時間。

As I mentioned above, this is an area focused with our collaboration partners and ongoing strategic planning. But it is also worth noting when Bravado came to market, it was a change for these centers as well in terms of patients needing to occupy rooms and monitoring requirements.

正如我上面提到的，這是我們的合作夥伴和持續策略規劃重點關注的領域。但值得注意的是，當 Bravado 進入市場時，這些中心在患者需要佔用房間和監控要求方面也發生了變化。

Certainly, (inaudible) growth would suggest that these centers have adapted and are growing along with awareness and patient demand.

當然，（聽不清楚）的成長表明這些中心已經適應並隨著意識和患者需求而增長。

As mentioned before, I've been impressed with the work today. A great foundation has been established and I look forward to advancing our approach to commercialization.

正如之前提到的，今天的工作給我留下了深刻的印象。一個偉大的基礎已經建立，我期待著推進我們的商業化方法。

We have work to do to determine exactly how we will optimize the commercial opportunity. But my team and I are committed to ensuring comp 360 if approved can get to patients and we will be working tirelessly to ensure the market is ready.

我們還有很多工作要做，以確定我們將如何優化商業機會。但我和我的團隊致力於確保 comp 360 在獲得批准後能夠惠及患者，我們將不懈努力，確保市場做好準備。

I look forward to meeting with many of you in the future and providing additional insights as we progress and learn more.

我期待著將來與你們中的許多人會面，並隨著我們的進展和了解更多資訊提供更多見解。

Let me now hand the call to Teri for the financial overview.

現在讓我把電話轉給泰瑞，了解財務概況。

Thank you, Lori. I'll now step through the Q3 financial results. Cash used in operations in the third quarter was $22.2 million which includes $13.6 million related to our 2023 R&D tax credit that we received in full in the third quarter but had not originally been included in our third quarter. Cash guidance as the timing was uncertain excluding this tax credit, cash used in operations would have been $35.8 million which is at the midpoint of the range for guidance that we provided of 32 to $38 million.

謝謝你，洛瑞。我現在將逐步介紹第三季的財務表現。第三季營運中使用的現金為 2,220 萬美元，其中包括與 2023 年研發稅收抵免相關的 1,360 萬美元，我們在第三季全額收到但最初並未計入第三季。現金指引由於時間不確定，不包括這項稅收抵免，營運中使用的現金將為 3,580 萬美元，處於我們提供的 3,200 至 3,800 萬美元指導範圍的中點。

Regarding fourth quarter, 2024 financial guidance, we expect net cash used in operations to increase to between 37 and $43 million which would put cash used in operations for the full year 2024 between 114 and $120 million near the midpoint of our prior guidance and includes the 2023 R&D tax credit that we received this quarter and which had been contemplated in the original full year guidance at September 30th 2024 we had cash and cash equivalents of $207 million. This compares with $228.6 million at June 30th, 2024, debt under the Hercules loan facility was $29.8 million at the end of the third quarter.

關於2024 年第四季的財務指引，我們預計營運中使用的現金淨額將增加至37 至4,300 萬美元之間，這將使2024 年全年營運中使用的現金在114 至1.2 億美元之間，接近我們先前指引的中點，其中包括我們本季收到的2023 年研發稅收抵免，以及在2024 年9 月30 日的最初全年指導中所考慮的，我們擁有2.07 億美元的現金和現金等價物。相較之下，截至 2024 年 6 月 30 日，Hercules 貸款融資下的債務為 2.286 億美元，第三季末為 2,980 萬美元。

Given the timing and strategic changes made to the phase three readouts, we are taking actions to preserve cash and ensure our entire focus is on successfully completing the phase three comp 360 trials as quickly as possible.

鑑於第三階段讀數的時間安排和策略變化，我們正在採取行動保留現金，並確保我們的全部重點是盡快成功完成第三階段的 comp 360 試驗。

Therefore, we will be reducing our workforce including stopping our non-comp 360 preclinical efforts as well as the potential externalization of our digital tools.

因此，我們將減少員工數量，包括停止非公司 360 度臨床前工作以及數位工具的潛在外部化。

Over the last several years, we have developed digital tools and technology to test evidence-based methods for assessing mental health treatments. We are now exploring Externalizing these technologies, intellectual property and associated employees to a new company established by our cofounders that could potentially support an evidence-based approach for anyone developing and delivering mental health treatments for the benefit of patients.

在過去的幾年裡，我們開發了數位工具和技術來測試評估心理健康治療的實證方法。我們現在正在探索將這些技術、智慧財產權和相關員工外部化到我們聯合創辦人建立的新公司，這可能會支持任何人開發和提供心理健康治療以造福患者的實證方法。

We are still working through the details and look to a final decision on this externalization by Q1 2025. Collectively, these actions will result in a downsizing of the organization by approximately 30% while we are still working through the full details and impact on cash. We expect our cash runway to fund operations at least into 2026. Thank you and I'll now turn the call back to Kabir.

我們仍在研究細節，並期待在 2025 年第一季做出有關此外部化的最終決定。總的來說，這些行動將導致組織規模縮小約 30%，而我們仍在研究全部細節和對現金的影響。我們預計我們的現金跑道至少可以為 2026 年的營運提供資金。謝謝您，我現在將電話轉回給卡比爾。

Thank you, Tero and Laurie.

謝謝你們，特羅和勞裡。

We're applying the resources necessary to get these trials done as quickly as possible and best position come 360 for regulatory and commercial success and we continue to actively review all other ways to accelerate the 006 trial.

我們正在運用必要的資源來盡快完成這些試驗，並為監管和商業成功做好 360 度的最佳準備，我們將繼續積極審查所有其他方法來加速 006 試驗。

As I mentioned earlier, Mike has been traveling to clinical sites to fully understand where assistance may be needed.

正如我之前提到的，麥克一直前往臨床地點，以充分了解哪裡可能需要幫助。

And directing resources to them as we encounter challenges, we're addressing them rapidly and applying those learnings to the overall pivotal program.

當我們遇到挑戰時，我們會提供他們資源，快速解決這些問題，並將這些經驗應用到整個關鍵計畫中。

As Teri mentioned, we're also taking action to cut costs further.

正如泰瑞所提到的，我們也採取行動進一步削減成本。

Focus the organization and Preserve cash.

集中組織並保留現金。

In saying that I want to acknowledge that our actions today in reducing our workforce have much bigger implications, preserving cash.

我想說的是，我們今天減少勞動力的行動有更大的影響，可以保留現金。

I know that they will have a deep Impact on the lives of many employees and their loved ones. I Regret that and as a management team, we're committed to supporting them through this transition with our two robust phase three trials and our large phase 2B trial, we'll have more than 1,000 Patients' worth of data from well controlled trials as well as a full package of supporting studies for a filing. We're confident that we're well positioned for success with a clear plan and a committed team to deliver on.

我知道它們將對許多員工及其親人的生活產生深遠的影響。我很遺憾，作為管理團隊，我們致力於透過兩項穩健的三期試驗和大型 2B 期試驗來支持他們完成這一過渡，我們將獲得來自良好對照試驗的超過 1,000 名患者的數據，以及用於備案的一整套支持研究。我們相信，憑藉著清晰的計劃和忠誠的團隊，我們已經做好了成功的準備。

This plan. Thank you. And I'll now turn the call to the Operator for Q&A.

這個計劃。謝謝。現在我將把電話轉給接線員進行問答。

At this time.

此時。

I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad, we will pause for just a moment to compile the Q&A roster.

我想提醒大家，要提問，請按星號，然後按電話鍵盤上的數字一，我們將暫停片刻來整理問答名冊。

Your first question comes from the line of Ritu Baral with TD Cowen. Please go ahead.

你的第一個問題來自 Ritu Baral 和 TD Cowen 的對話。請繼續。

Hi guys. This is Athena and Thank you for taking my question. Was your decision to move the business top line readout made after additional FDA correspondence or a face-to-face meeting. And do you foresee any other changes to trial operations and conduct Thank you.

嗨，大家好。我是雅典娜，感謝您回答我的問題。您是否決定行動業務頂線讀數是在與 FDA 進行額外通信或面對面會議後做出的？您預計試營運和實施是否會有其他變化，謝謝。

Thanks Athena. It could be. So, that was a compass decision. It was a compass decision that we made out of an abundance of caution. really, after observing all.

謝謝雅典娜。可能是。所以，這是一個羅盤決定。這是我們出於非常謹慎的考慮而做出的決定。確實，在觀察了一切之後。

That happened through the Lycos process, and debating internally around the need to really maintain that blind through the blinded portion of 006. And you know, we said.

這是透過 Lycos 流程發生的，並且內部圍繞著是否需要在 006 的盲區中真正保持盲區進行爭論。你知道，我們說過。

On the trial on the call. We continue to look at all ways we can do to accelerate the conduct of 006 and that will continue to be an active effort.

就電話審訊。我們將繼續尋找各種方法來加速《006》的上映，這將繼續是一項積極的努力。

Understood. Thank You.

明白了。謝謝。

Your next question comes from the line of Leonid Timashev with RBC Capital Markets. Please go ahead.

您的下一個問題來自加拿大皇家銀行資本市場部的 Leonid Timashev。請繼續。

Hi guys. Thanks for taking my question. I guess I'm trying to understand how the potential complexities in the trial recruitment may or may not have any impact on how comp 360 would be used in the real world. I, I guess is this largely just due to limitations that you know, staffing sites or, or is this something where booking the therapist having, you know, all the appointments aligned is going to be a challenge for any initial commercial uptake. So there any learnings as you go through the clinical process that might inform how you go about commercialization, just trying to understand, you know, how much of this is also and versus really just.

嗨，大家好。感謝您提出我的問題。我想我正在嘗試了解試驗招募中潛在的複雜性可能會或可能不會對 comp 360 在現實世界中的使用方式產生任何影響。我想，這很大程度上只是由於您知道的限制，人員配置網站，或者，或者是預訂治療師的情況，您知道，所有預約都一致，這對於任何最初的商業吸收來說都是一個挑戰。因此，當您經歷臨床過程時，您所學到的東西可能會告訴您如何進行商業化，只是試圖了解，您知道，其中有多少是公正的，而與真正公正的相比。

No, thanks, Leo.

不，謝謝，利奧。

It's a really important question. I mean, and the fundamental answer is that a clinical trial setting is clearly very different from a commercial setting in the sense of what needs to be communicated to patients and so on. But let me ask Lori to amplify that a little with some of the key differences and how we're thinking about the commercial side.

這是一個非常重要的問題。我的意思是，根本的答案是，在需要向患者傳達什麼訊息等方面，臨床試驗環境顯然與商業環境有很大不同。但讓我請 Lori 稍微闡述一些關鍵差異以及我們如何考慮商業面。

Thank you for the question.

謝謝你的提問。

So, you know, as you know, clinical trials are intentionally onerous because they're working to fit within a regulatory construct, we do not anticipate that it will flow over to the commercial side. Most likely what will happen in clinic in commercial operations when when the product is approved is that it will positions will be regulated based on what they're restricted by, by utilization management, formulary access. And, and things like that.

所以，你知道，臨床試驗是故意繁重的，因為它們正在努力適應監管結構，我們預計它不會流向商業方面。當產品獲得批准時，在商業運營的臨床中最有可能發生的情況是，它將根據使用管理、處方准入的限制對其位置進行監管。還有諸如此類的事情。

From an operational standpoint, we are learning a lot from our clinical sites.

從營運的角度來看，我們從臨床站點學到了很多。

We're also learning a lot from our key collaborations that we mentioned on the call. And a lot of that has to do with really optimizing, you know, the patient flow and the way that I think about how we will go about optimizing the patient flow, which is, you know, we're learning from the clinical clinical trials but is not necessarily analogous to the clinical trials is that you have to think about it in two ways.

我們也從電話會議中提到的關鍵合作中學到了很多。其中很大一部分與真正優化患者流程有關，以及我思考如何優化患者流程的方式，您知道，我們正在從臨床試驗中學習但不一定與臨床試驗相似的是，你必須從兩個方面來思考它。

One, you have to make sure that the patients are adequately being referred from referring physicians to the to the trial sites. That's what's happening in the clinical trials. It will be a very similar situation in commercialization, we're going to need to work very hard to make sure that physicians are adequately educated to, to make sure that they're referring patients to, to the treatment centers. This requires education, this requires education on TRD. It's really helping physicians identify the appropriate patients and really making sure that they understand compen clinical benefit.

第一，您必須確保將患者從轉診醫生充分轉介到試驗地點。這就是臨床試驗中發生的情況。這將是商業化中非常相似的情況，我們需要非常努力地確保醫生接受充分的教育，以確保他們將患者轉診到治療中心。這需要教育，這需要 TRD 教育。它確實可以幫助醫生識別合適的患者，並真正確保他們了解補償臨床益處。

This will all come very naturally through, you know, a sales and marketing effort as we get closer to launch the second piece of it, which I think is important for, for the underlying piece of your question. And that really is ensuring capacity of patient flow at the treatment sites.

你知道，隨著我們越來越接近推出第二部分，這一切都會透過銷售和行銷工作自然而然地實現，我認為這對你問題的根本部分很重要。這確實是在確保治療地點的患者流動能力。

You can think about this in my, in my mind, I think about it in two ways, you can either go broad and, and really have an inefficient process where you have a lot of treatment sites and not a lot of patients flowing through. Or you can think about how you might optimize the the the opportunity at your sites. And really, you know, look at a real concentrated effort where you're optimizing opportunities to make that patient flow efficient at those treatment sites. And those are a lot of things we're learning from our, our collaboration partners. We're taking a look at opportunities there.

你可以在我的腦海中思考這個問題，我以兩種方式思考這個問題，你可以廣泛考慮，並且確實有一個低效的過程，你有很多治療地點，但沒有很多病人流經。或者您可以考慮如何優化您網站上的機會。事實上，你知道，看看真正集中的努力，你正在優化機會，使患者在這些治療地點的流動效率很高。這些是我們從我們的合作夥伴那裡學到的很多東西。我們正在尋找那裡的機會。

Your next question comes from the line of Charles Duncar with Cantor Fitzgerald. Please go ahead.

你的下一個問題來自查爾斯·鄧卡（Charles Duncar）和康托·菲茨杰拉德（Cantor Fitzgerald）的台詞。請繼續。

Okay. Morning bear in team. Although I'm a little disappointed on pointed on timing. I do really appreciate the focus on maintaining rigorous clinical evaluation and ultimate regulatory success. So I have a question about, you know, what has changed over the course of the last six weeks. Have you discussed this with the agency in terms of O and, and is it possible that your regulatory strategy in terms of 05 and 06 being necessary has perhaps changed? Or do you have any other thinking about that?

好的。晨熊在團隊中。儘管我對時間點有點失望。我真的很欣賞對維持嚴格的臨床評估和最終監管成功的關注。所以我有一個問題，你知道，過去六週發生了什麼變化。您是否與該機構就 O 和 方面討論過這一問題？或者說你對此還有其他的想法嗎？

Thanks for the question, Charles. And the short answer is no. Nothing about our regulatory strategy has changed. At this point. What has changed clearly is a decision around what data we disclosed from 006.

謝謝你的提問，查爾斯。簡短的回答是否定的。我們的監管策略沒有任何改變。在此刻。明顯變化的是關於我們披露 006 數據的決定。

When? But. We would still.

什麼時候？但。我們仍然會。

Anticipate the base case. Is.

預測基本情況。是。

That 005 and 006 are needed for a filing?

備案需要005和006嗎？

Okay. And, and if you could provide a little bit of color on the enrollment patterns, are you still feeling good about the ability to wash out patients from anti-depressant meds that are standard of care or is that not a complexify at all to the enrollment?

好的。而且，如果您可以在註冊模式上提供一些顏色，您是否仍然對將患者從標準護理的抗憂鬱藥物中剔除的能力感到滿意，或者這對註冊來說根本不是複雜的？

I'll pass that to Mike.

我會把它轉給麥克。

It's Michael. So we are actually seeing a greater than 90% successful washup rate for standard of care coming into the trials. I think we just published and I confirm with the guy that it just came out a paper reporting on that from the phase two study. So this is not a, it's not a logistical obstacle. It does remain a point of education for our investigators and clinicians in the community because there is some, there is a reluctance to, to sort of tell patients they do wash out. But in fact, and from what we observe from the trials, it's not a problem. We have not seen a (inaudible) effect from withdrawal. And like I said, higher than 90% ability to complete that wash out in our trials right now.

是麥可。因此，我們實際上看到試驗中標準護理的成功清洗率超過 90%。我想我們剛剛發表了，我向那個人證實，剛剛發表了一篇報告第二階段研究的論文。所以這不是一個後勤障礙。對於社區中的研究人員和臨床醫生來說，這確實仍然是一個教育點，因為有些人不願意告訴病人他們確實被淘汰了。但事實上，從我們從試驗中觀察到的情況來看，這不是問題。我們還沒有看到戒斷產生（聽不清楚）的影響。就像我說的，目前在我們的試驗中完成清除的能力高於 90%。

Yeah, we saw that journal site research paper was helpful. I appreciate that. Last question is with regard to 06 timing, the shift to 26 weeks, you know, seems like a year and yet that seems like it could be a little bit longer than you would expect just due to the shift. So, is there also a modulation of enrollment or your, your confidence in enrollment in 06 as well?

是的，我們看到期刊網站的研究論文很有幫助。我很欣賞這一點。最後一個問題是關於 06 的時間安排，你知道，轉變為 26 週，看起來像是一年，但由於轉變，它似乎可能比你預期的要長一點。那麼招生也有調整嗎,或者說你對06年的招生也有信心嗎?

Your maths is correct. What I would say is we.

你的數學是正確的。我想說的是我們。

As we said on the call, there is still some uncertainty around the recruitment curve. I think we're very confident. Therefore, on the guidance we've given for the 26 week endpoint, but we're doing everything we can to continue to accelerate both with European sites. And also with the expectation that as 005 finishes those experienced sites that have done well in 005 will roll into 006, which will be an inflection point. In that curve. So you're correct. It does incorporate an element of conservatism as well around moving from 6 to 26 weeks.

正如我們在電話會議上所說，招募曲線仍存在一些不確定性。我認為我們非常有信心。因此，根據我們為 26 週終點提供的指導，我們正在盡一切努力繼續加快歐洲站點的速度。並且預計隨著005的完成，那些在005中表現出色的經驗豐富的網站將進入006，這將是一個轉折點。在那條曲線裡。所以你是對的。它確實包含了保守主義的元素以及圍繞著從 6 週到 26 週的變化。

Super one question for Teri in terms of more math, checking my math. And that is, it seems like you have sufficient cash through 25 (inaudible)06 seems a little bit more of a stretch to me. Could you anticipate having sufficient cash through the read? Given the current view on timing for 06.

泰瑞的一個關於更多數學的超級問題，檢查我的數學。也就是說，您似乎在 25（聽不清楚）06 之前都有足夠的現金，對我來說似乎有點困難。您能預期透過閱讀可以獲得足夠的現金嗎？鑑於目前對 06 年時間安排的看法。

Yeah, thanks for the question, Charles. So as we had mentioned, we have $207 million of cash as of the end of the third quarter, that gets us at least into 2026. We are, we announced a restructuring along with these with these delays, excuse me as the trials do cost more as, as they go longer. And so the savings that we have that we anticipate from the restructuring are meant to offset that and preserve cash.

是的，謝謝你的提問，查爾斯。正如我們所提到的，截至第三季末，我們擁有 2.07 億美元的現金，這至少能讓我們進入 2026 年。我們是，我們宣布了重組以及這些延誤，請原諒，因為試驗的成本隨著時間的延長而增加。因此，我們預計重組所節省的資金旨在抵消這一損失並保留現金。

We are still doing some detailed analysis on the potential for savings and working through whether we might be able to incorporate additional savings to further extend runway. And that is work that we'll be doing here over the coming weeks. So, we're very comfortable, we'll have cash at least into 26 if we can extend beyond that. That's the work that we're doing, and we are committed to being disciplined in our expenses and our spend and ensuring comp 360 success.

我們仍在對節省的潛力進行一些詳細分析，並研究是否能夠納入額外的節省以進一步延長跑道。這就是我們未來幾週將在這裡做的工作。所以，我們非常放心，如果我們能超越這個數字，我們至少會有 26 美元的現金。這就是我們正在做的工作，我們致力於嚴格控制開支和開支，確保 comp 360 取得成功。

Okay, appreciate all the color. Thanks for taking my questions.

好吧，欣賞所有的顏色。感謝您回答我的問題。

Thanks, Charles.

謝謝，查爾斯。

Your next question comes from the line of Francois Reservoir with Oppenheimer. Please go ahead.

你的下一個問題來自弗朗索瓦水庫與奧本海默的關係。請繼續。

Thanks for the question. I just want to touch back on, on something that was brought up on a prior question about the difference between clinical and commercial and it, it seemed like the answer was there is clearly a difference. At the same time, the education will be similar in terms of referrals on the commercial side. Could you just help us understand maybe why you still feel comfortable with maybe, you know, sales potential and, and just, and also as a second question, can you help us understand what needs to be done between these final like data readouts now? And you know, launch and just like what would be a good estimate for a year there? Thank you.

謝謝你的提問。我只想回顧之前關於臨床和商業之間差異的問題中提出的一些問題，答案似乎是明顯存在差異。同時，在商業方面的推薦方面，教育也將相似。您能否幫助我們理解為什麼您仍然對銷售潛力感到滿意，並且，作為第二個問題，您能否幫助我們理解現在在這些最終數據讀數之間需要做什麼？你知道，發射，就像在那裡一年的良好估計是多少？謝謝。

Thanks Frank. So I'm.

謝謝弗蘭克。所以我是。

Not quite sure I caught the second part of the question.

不太確定我明白了問題的第二部分。

What, what needs to be done in what context sorry.

抱歉，在什麼情況下需要做什麼。

In context of launch, you know, between the final readouts now with the timeline pushes, just trying to understand if what else has to be done after these readouts to move forward to launch. Thank you.

在發射的背景下，你知道，在現在的最終讀數和時間軸推送之間，只是想了解在這些讀數之後是否還需要做些什麼才能繼續發射。謝謝。

Sure. I'll pass that to Laurie. Thanks.

當然。我會把它轉給勞裡。謝謝。

Yes. So I'll answer your first one. I try to give you a little more clarity around the first one. Again, you know, really thinking about the, the main question that we get from either htps that we're in discussion with or, you know, HCPS that, that we're working with or, you know, clinical or the trial sites as well as, you know, the collaboration sites that we're, we're working with. What I'll shift gears to is, is really what's needed between now and launch and what I like to focus on is, is what we're actually doing right now. What our immediate focus is. So right now, you know, the things that we need to focus on are really increasing the awareness around TRD and educating on comp 360 phase two data. That's what our MS Ls are out in the field doing right now. So that is a very concerted effort. And obviously, we're learning a lot from the feedback from, from Kols around that.

是的。那我就回答你的第一個。我試圖讓您對第一個問題更加清楚。再次，你知道，認真思考我們從我們正在討論的 htps 或我們正在合作的 HCPS 或臨床或試驗地點中得到的主要問題以及我們正在合作的協作網站。我要轉向的是，從現在到發布之間確實需要什麼，我喜歡關注的是，我們現在實際上正在做的事情。我們目前的重點是什麼。所以現在，我們需要關注的事情是真正提高人們對 TRD 的認識，並對 comp 360 第二階段資料進行教育。這就是我們的 MS L 現在正在現場做的事情。所以這是一個非常一致的努力。顯然，我們從科爾斯的回饋中學到了很多。

Another important area of focus for us is really making sure that states get rescheduled in a very timely manner after DEA scheduling, that is a, you know, an effort that is unique to us, given that we're currently setting, sitting at a schedule one product. So we need to be able to get the states rescheduled in a timely manner in order for physicians to prescribe and we can distribute the product to those states.

我們關注的另一個重要領域是確保各州在 DEA 安排之後非常及時地重新安排時間，這是我們獨有的努力，因為我們目前正在設定，坐在一個安排一種產品。因此，我們需要能夠及時重新安排各州的時間，以便醫生開處方，並且我們可以將產品分發到這些州。

The other effort that we're, we're really focusing on. Again, I I've said it a couple of times is really focusing on how we optimize that patient flow. And again, that's learning through our collaborations and, and the partnerships that we have in place as well as anything that we learn from KOL interactions with our MSLS and obviously from the clinical trials.

我們真正關注的另一項努力。我再說一遍，我已經說過幾次，真正關注的是我們如何優化患者流程。再說一次，這是透過我們的合作和我們現有的合作夥伴關係以及我們從 KOL 與我們的 MSLS 互動以及顯然從臨床試驗中學到的任何東西來學習。

And then of course, we are, you know, acutely aware of the importance of getting good formulary access. And so right now, our (inaudible) team is working diligently to, to build a robust information set so that we can be armed with good data to present the payers when the time comes.

當然，我們敏銳地意識到獲得良好處方的重要性。因此，現在，我們的（聽不清楚）團隊正在努力建立一個強大的資訊集，以便我們能夠掌握良好的數據，以便在時機成熟時向付款人展示。

So, I'll just revisit some of the, the reasons why I'm excited for, for comp 360. And that, that's probably a better approach.

因此，我將回顧我對 comp 360 感到興奮的一些原因。這可能是更好的方法。

I think we have a lot of learnings to do. We have a lot of challenges that we'll, we'll need to overcome. But we have time to figure those out being first to market takes time and we are, we will be first in class, first to market.

我認為我們還有很多值得學習的地方。我們有很多挑戰需要克服。但我們有時間弄清楚這些，首先進入市場需要時間，而我們是，我們將是一流的，首先進入市場的。

And that is a situation where you need a lot of time to think through strategy and planning.

在這種情況下，您需要大量時間來思考策略和規劃。

And so we have time to work through some of these, these complex issues that, that present themselves with the administration of comp 360 figure out how we can optimize you know that patient flow.

因此，我們有時間解決其中一些複雜的問題，這些問題在 comp 360 的管理中出現，找出我們如何優化患者流程的方法。

The reason I'm excited is you have a great analog in Spravato. Spravato again, launched into these interventional psychiatry centers and they were able to adapt and we all know it's well on, on, on path to be a billion dollar product, they've steadily grown their sites since their launch and they're now sitting at well over 4,000 sites, there is a natural overlap with prescribers. Obviously, it is the only marketed TRD product out there. And our, our prescribers will be natural overlaps.

我感到興奮的原因是你在 Spravo 中有一個很棒的模擬。Spravo 再次進入這些介入精神病學中心，他們能夠適應，我們都知道它正在成為 10 億美元的產品，自推出以來，他們的網站一直在穩步發展，現在他們正坐在在4,000 多個地點，開處方者自然存在重疊。顯然，它是目前唯一上市的 TRD 產品。我們的處方者將是自然重疊的。

Your next question comes from the line of Vikram Purohit with Morgan Stanley. Please go ahead.

您的下一個問題來自 Vikram Purohit 與摩根士丹利的對話。請繼續。

Hi, everyone. Thanks for taking our questions. This is Morgan on for Vikram. So we have two on the 005 program. First, would you expect a change to the profile of patients enrolled in the trial? Given the delay and second, given the delay or any of the parameters of data that you'll report for this release different versus prior expectations? Thank you.

大家好。感謝您回答我們的問題。這是摩根替維克拉姆上場。所以我們在 005 計劃上有兩個。首先，您預計參加試驗的患者資料會有所改變嗎？考慮到延遲和第二，考慮到延遲或您將為此版本報告的任何資料參數與先前的預期不同嗎？謝謝。

Thanks Morgan and I'll.

謝謝摩根，我會的。

Answer both no in both cases so that the, you know, the focus is on recruiting executive same patients consistent throughout the trial. And in terms of guidance about what we released today was clarifying what we had always expected to say. So no changes on either of those.

在這兩種情況下都回答“否”，這樣，你知道，重點是招募在整個試驗過程中保持一致的相同患者。就我們今天發布的內容而言，我們澄清了我們一直期望說的話。所以這兩方面都沒有改變。

Okay. And if I may squeeze one more question in there, how is your focus on non TRD indications including PTSD impacted by these timeline delays? I know you mentioned the de prioritization of pre clinical efforts. But what does it look like for some of the clinical indications?

好的。如果我可以再問一個問題，您對非 TRD 適應症（包括受這些時間延遲影響的 PTSD）的關注程度如何？我知道您提到了臨床前工作的優先順序。但某些臨床適應症是什麼樣的呢？

So as you, as you know, we have clearly said PTSD is an area of significant interest, very high unmet need. We have very compelling albeit small data set from phase two. What we've also said is while we have planned for moving that ahead, that is not in our current runway. So that situation has not changed. We have plans in hand, but we're not in a position to execute on them at this time.

如你所知，我們已經明確表示，創傷後壓力症候群是一個備受關注的領域，其未滿足的需求非常高。我們有第二階段的資料集，儘管資料集很小，但非常引人注目。我們也說過，雖然我們已計劃向前推進，但這不在我們目前的範圍內。所以這種情況沒有改變。我們手頭上有計劃，但目前無法執行。

Okay. Thank you.

好的。謝謝。

Your next question comes from the line of Elemer Piros with Rodman. Please go ahead.

你的下一個問題來自埃萊默·皮羅斯和羅德曼的對話。請繼續。

Yes, good morning. What I'd like to ask is about the eligibility for retreatment.

是的，早安。我想問的是關於復診資格的問題。

Is there any difference between the, the, the time period between week six and 26 and between 26 weeks and 52 weeks?

第六週和第二十六週以及第二十六週和第五十二週之間的時間段有什麼區別嗎？

And maybe a part B to this question is, how do we define relapse? And if someone went back on to an antidepressant, do you want them to wean them off before retreatment with count 360.

也許這個問題的 B 部分是，我們如何定義復發？如果有人重新開始服用抗憂鬱藥，您是否希望他們在重新接受第 360 條治療之前戒掉這些藥物？

Guys? If I may.

夥計們？如果可以的話。

Ask you to take.

請你拿走。

That.

那。

Hi Elemer, the second question is quite simply that if people have gone back on to antidepressants, then they can stay on them particularly. This would be in part c where this will commonly occur. We think and we obviously offer quite important useful information about the feasibility of administering the drivers of coadministration. The criteria for retreatment are simply a threshold on the Madras. And they're not different between the two phases B&C.

你好，Elemer，第二個問題很簡單，如果人們重新開始服用抗憂鬱藥，那麼他們可以特別繼續服用這些藥物。這將在 c 部分中，通常會發生這種情況。我們認為並且顯然我們提供了關於管理共同管理驅動因素的可行性的非常重要的有用資訊。重新治療的標準只是馬德拉斯的一個門檻。B&C 兩個階段之間沒有什麼不同。

So, either patients who have not recovered or patients who have recovered and then relaps have to meet the same criteria, essentially.

因此，無論是尚未康復的患者還是已康復然後復發的患者，本質上都必須滿足相同的標準。

Thank you very much.

非常感謝。

Hi.

你好。

Your next question comes from the line of Gavin Clark-Gartner with Evercore. I sir please go ahead.

您的下一個問題來自 Evercore 的 Gavin Clark-Gartner。先生，請繼續。

Hi, this is ya on for Gavin. Thanks for taking our question. For us you notice for 005 that you won't be providing a detailed safety table, but you'll be providing comments on potential suicidal ideation, imbalances. We were just wondering what rate do you and or the DSMB, consider an imbalance essentially just how is that defined and what will that update kind of look like? Thank you.

嗨，這是加文的節目。感謝您提出我們的問題。對於我們來說，您注意到 005 您不會提供詳細的安全表，但您會提供有關潛在自殺意念和不平衡的評論。我們只是想知道您和/或 DSMB 的費率是多少，從本質上考慮不平衡是如何定義的以及更新會是什麼樣子？謝謝。

So I, I'll start.

那我，我就開始吧。

I mean, the DSNB is independent. So it's up to the DSNB to tell us what they consider an imbalance, but I don't know Mike if you'd like to amplify that at all.

我的意思是，DSNB 是獨立的。因此，DSNB 應該告訴我們他們認為什麼是不平衡，但我不知道 Mike 您是否願意進一步闡述這一點。

So, so I don't think we're in a place where I can give you quantitative criteria. I think that it depends on the degree of imbalance, but also on the nature of the cases and severity of the ideation or planning, etc. So, this is a place where we have, you know, could be appointed, it's an independent DSN B and then the charter gives them a lot of latitude in that space. So, what you know, so I'm I'm going to park the response there I don't have a number to give you. It really depends on your clinical interpretation of the cases that they see.

所以，我認為我們無法為您提供定量標準。我認為這取決於不平衡的程度，也取決於案件的性質以及構想或計劃的嚴重程度等。裡很大的自由度。所以，你知道的，所以我要把回覆放在那裡，我沒有數字可以給你。這實際上取決於您對他們所看到的病例的臨床解釋。

Thank you.

謝謝。

Your next question comes from the line of Patrick Trucchio with HC Wainwright & co. Please go ahead.

您的下一個問題來自 HC Wainwright & co 的 Patrick Trucchio。請繼續。

Hello, good morning. So I have a few questions. The first is, is the expectation that you will continue to need data from both comp 05 and 06 to submit the NDA for comp 360 TRD. And secondly, can you tell us if the expectation is that there will be an advisory committee to assess potential of comp 360 TRD. And then can you talk more about how the data that's generated from these trials? The 05 and 06 trials with these updated timelines discussed earlier should put you in a better position to address potential questions during a potential advisory committee.

你好早安。所以我有幾個問題。第一個是，預計您將繼續需要 comp 05 和 06 的資料來提交 comp 360 TRD 的 NDA。其次，您能否告訴我們是否期望會有一個諮詢委員會來評估 comp 360 TRD 的潛力。然後您能多談談這些試驗產生的數據是如何產生的嗎？前面討論過的 05 和 06 試驗以及這些更新的時間表應該可以讓您更好地在潛在的諮詢委員會期間解決潛在的問題。

Thanks very much Patrick. So I'll answer very.

非常感謝派崔克。那我就回答一下吧。

Quickly. Yes and yes to questions One and two.

迅速地。對問題一和問題二是是和是。

We continue to guide that. We'll need data from both. We absolutely expect an adcom based on the fact that this is a schedule one product and precedent is always there will be And for the third part, our past to Mike.

我們將繼續對此進行指導。我們需要兩者的數據。我們絕對期待一個基於這樣一個事實的adcom：這是一個時間表產品，並且先例總是存在的。

Which.

哪個。

Is do these changes, you know, help us, we believe put us in a stronger position to address issues that might come up as an outcome.

您知道，這些變化是否對我們有幫助，我們相信使我們處於更有利的地位來解決可能出現的問題。

Well, I mean, I think to the extent that we preserve the integrity of the 06 study and reduce any bias in terms of unblinding. Yes, it helps us because clearly the agency while, while aware of it, you know, just wants fosters to do whatever they can to minimize the functional unblinding. I was just going to add to your stomach. We're going to be probably first in class and generally speaking for first in class, the agency generally calls, you know, for outcomes even in areas as mundane as antibiotics. So.

嗯，我的意思是，我認為我們要保持 06 研究的完整性並減少揭盲的任何偏見。是的，這對我們有幫助，因為很明顯，該機構雖然意識到這一點，但只是希望寄養者盡其所能，盡量減少功能性揭盲。我只是想給你的胃加點東西。我們可能會成為一流的，一般來說，為了一流，該機構通常要求，你知道，即使在像抗生素這樣平凡的領域也是如此。所以。

Right, that's, that's helpful. And then just can you frame for us more broadly as we think about you know, compounds that have been approved recently trials that are underway. What would be considered a positive outcome in terms of improvement on the mare scale in a phase three TRD trial, both in terms of reduction from baseline and active treatment relative to placebo. And then separately, I'm wondering as we, you know, are going to see this the, the, you know, the top line data from the comp 05 trial. How do you envision that that data will read through to the 06 trial just given the differences in the way these studies have been designed.

對了，就是這樣，很有幫助。然後，您可以更廣泛地為我們建立框架，因為我們認為您知道，最近已批准的化合物正在進行正在進行的試驗。在第三階段 TRD 試驗中，就母馬量表的改善而言，什麼被認為是正面的結果，無論是從基線的減少還是相對於安慰劑的積極治療。然後，我想知道，我們將看到來自 comp 05 試驗的頂線數據。考慮到這些研究設計方式的差異，您如何設想這些數據將貫穿 06 次試驗。

So, processing your question here about effect size. So, I would say, well, we're, we let me, let me see if I can sort of answer your second first in the sense of the impact of. So, this is one of the reasons why we are limiting the amount of data that we are releasing from 05 because we're going to be releasing data while 06 is still in sort of both part, some part A and some patients in part B. So, we, we want to be really prudent about how much we put out there. We're also this, this, the sites that are running 05 and six at this point are none. So we, we don't have any sites that are running both studies at the same time. So they're non overlapping sites and they're not. And other than the US, there are different geographies as well. So we're doing, we are doing everything that we can to, to minimize or blunt any sort of readthrough from 05 dose for our success is a de detecting a clinically relevant difference. And in TRD that varies, maybe a little bit lower in terms of protects us compared to NTD just because of the difficulty of, of, of the population. So I'm going to, I'm going to defer to actually give you a number on, on exactly what that effects looks like in, in points on the mattress. We, we're just, we have adequate power for clinically relevant differences in our studies.

因此，在這裡處理您關於效應大小的問題。所以，我想說，好吧，我們讓我看看我是否可以從影響的意義上回答你的第二個問題。因此，這就是我們限制從 05 開始發布的數據量的原因之一，因為我們將在 06 仍然處於兩個部分（部分 A 部分和部分 B 部分患者）的同時發布數據。要非常謹慎。我們也是這個這個，現在運行05、6個的站點都沒有。所以我們沒有任何網站同時進行這兩項研究。所以它們不是重疊的站點，也不是。除了美國之外，還有不同的地區。因此，我們正在盡我們所能，最大限度地減少或削弱 05 劑量的任何類型的通讀，因為我們的成功是檢測臨床相關差異。TRD 的情況有所不同，與 NTD 相比，在保護我們方面可能要低一些，只是因為人口的困難。所以我會，我會延後實際給你們一個數字，具體說明床墊上的效果到底是什麼樣的。我們，我們只是，我們有足夠的權力來處理我們研究中臨床相關的差異。

Got it. Thanks so much. Yes, that, that's helpful. Thank you very much.

知道了。非常感謝。是的，這很有幫助。非常感謝。

Your next question comes from the line of Thomes Shrader with BTIG. Please go ahead.

您的下一個問題來自 BTIG 的 Thomes Shrader。請繼續。

Thanks for taking the question given the comp the comments about complexity and all that are your dropout rates tracking as expected and you haven't said you're adding patients, are.

感謝您提出問題，考慮到補償委員會對複雜性的評論以及您按預期跟踪的退出率，並且您沒有說過要增加患者，都是如此。

You? Thanks.

你？謝謝。

Mike.

麥克風。

Yeah. Yeah. So, the attrition rate is actually running a little bit below our, our, our plan. So subjects are staying in the study. So we are, we are not experiencing a higher than planned attrition. We are not changing the sample size. We are not doing any adjustments to the sample size in the study. We are emphasizing and for I hope reasons that are very clear how to accelerate recruitment and complete the studies as quickly as possible and how to enhance retention so that we minimize our missing data problem. But for the moment attrition is is well within the planning parameters.

是的。是的。所以，流失率其實略低於我們的計畫。所以受試者就留在研究中。所以我們的人員流失率並沒有高於計畫。我們不會改變樣本量。我們沒有對研究中的樣本量進行任何調整。我們正在強調，我希望原因非常明確，如何加速招募並儘快完成研究，以及如何提高保留率，以便我們最大限度地減少丟失資料的問題。但目前，人員流失完全在計畫參數之內。

Okay. Thank you.

好的。謝謝。

Your next question comes from the line of Sumant Kulkarni with Canaccord Genuity LLC. Please go ahead.

您的下一個問題來自 Canaccord Genuity LLC 的 Sumant Kulkarni。請繼續。

Hi, thanks for taking my questions. I have (inaudible)005. Roughly what percentage of the trial participants do you expect that would have completed the 26 weeks at the time you announced the six week data. And what prompted the decision to announce top line at six weeks for 005 versus waiting for the full 26 weeks, which might give us more insight into durability of treatment as well. And I have a follow up after that.

您好，感謝您回答我的問題。我有（聽不清楚）005。當您宣布 6 週數據時，您預計大約有多少百分比的試驗參與者能夠完成 26 週的試驗。是什麼促使我們決定在 005 的六週後公佈頂線，而不是等待整整 26 週，這也可能讓我們更深入地了解治療的持久性。之後我會跟進。

Yeah, so, I can't.

是的，所以，我不能。

Give you an answer to the first part, but just to be clear on the second, we have always guided for releasing six week data of 005.

給你第一部分的答案，但為了澄清第二部分，我們一直指導發布005的六週數據。

I think, you know, as you're very well aware, the designs are very different in 006. That is a design that the agency themselves recognize is the best possible to preserve blinding. And that's why our focus on preserving blinding in 006. So our decision on 005 has never changed from what we've guided in the past.

我想，正如你們非常清楚的那樣，006 中的設計非常不同。該機構自己認為這種設計是防止致盲的最佳方案。這就是我們在 006 中重點保留致盲的原因。所以我們對005的決定從來沒有改變過我們過去的指導。

Got it. And then a commercial question for Lori, do you think the current phase three program gives you enough commercial firepower to address what three treatment schedule might be needed in the real world as it has potential implications for pricing?

知道了。然後是洛里的一個商業問題，您認為當前的第三階段計劃是否為您提供了足夠的商業火力來解決現實世界中可能需要的三種治療方案，因為它對定價有潛在影響？

Yeah, I'm sorry. Could you, would you mind repeating the question? Does it.

是的，對不起。你介意重複一下這個問題嗎？做到了。

Give us enough data for the schedule and that to address pricing?

為我們提供足夠的時間表和定價數據嗎？

Oh, we, we believe it does. And we, we think that that it will be a very important piece of information and relevant to, to payers and to see what that looks like.

哦，我們，我們相信確實如此。我們認為，這將是一條非常重要的訊息，與付款人相關，並看看它是什麼樣子。

Thanks.

謝謝。

Thanks much.

非常感謝。

Seeing as we do not have any more questions at this time, I will now turn the call back over to the management for closing remarks.

鑑於我們目前沒有更多問題，我現在將把電話轉回給管理層進行總結發言。

Thanks for what we at compas are.

感謝我們compas 所做的一切。

Completely focused on the execution of our pivotal trials while as we've said, continuing to maintain the highest quality with an urgency and a commitment to bring comp 360 to patients in need. Our.

我們完全專注於關鍵試驗的執行，同時正如我們所說，繼續保持最高品質，並致力於將 comp 360 帶給有需要的患者。我們的。

Confidence in comp 360.

對 comp 360 充滿信心。

Remains steadfast and we are excited by what's ahead.

保持堅定，我們對未來感到興奮。

Thank you again for joining the call today and we look forward to further conversations with all of you. Thank you.

再次感謝您今天加入電話會議，我們期待與大家進行進一步的對話。謝謝。

Ladies and gentlemen, that concludes today's call. Thank you all for joining you. May now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入。現在可以斷開連線。