Compass Pathways PLC (CMPS) 2023 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Compass Pathways First Quarter 2023 Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephen Schultz. Please go ahead.

美好的一天，感謝您的支持。歡迎參加 Compass Pathways 2023 年第一季度電話會議。 （操作員指示）請注意，今天的會議正在錄製中。我現在想把會議交給今天的發言人斯蒂芬·舒爾茨。請繼續。

Welcome, all of you, and thank you for joining us today for our first quarter 2023 results conference call. Again, my name is Steve Schultz, I'm the Senior Vice President of Investor Relations at Compass Pathways. Today, I'm joined by Kabir Nath, our Chief Executive Officer; Dr. Guy Goodwin, our Chief Medical Officer; and Mike Falvey, our Chief Financial Officer. The call is being recorded and will be available on the Compass Pathways' Investor Relations website shortly after the conclusion of the call.

歡迎大家，並感謝您今天參加我們的 2023 年第一季度業績電話會議。再說一遍，我叫史蒂夫·舒爾茨 (Steve Schultz)，是 Compass Pathways 投資者關係高級副總裁。今天，我們的首席執行官 Kabir Nath 也加入了我的行列。我們的首席醫療官 Guy Goodwin 博士；和我們的首席財務官邁克·法爾維 (Mike Falvey)。電話會議正在錄音，電話會議結束後不久將在 Compass Pathways 的投資者關係網站上公佈。

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

在開始之前，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案》及其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。由於各種風險、不確定性和其他因素，包括我們 10-Q 季度報告中“風險因素”標題下描述的風險和不確定性，實際事件或結果可能與任何前瞻性陳述明示或暗示的事件或結果存在重大差異向美國證券交易委員會提交的文件以及 Compass 隨後向 SEC 提交的文件中。

Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements, even if our estimates or assumptions change.

此外，這些前瞻性陳述僅代表我們今天的觀點，不應被視為代表我們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。

And with that, I will now hand the call over to Kabir Nath.

現在，我將把電話轉交給卡比爾·納斯。

Thank you, Steve. Good day, everyone, and thank you for joining us. During this past quarter, Compass Pathways has continued to make excellent progress with our COMP360 Phase III pivotal program in treatment-resistant depression, or TRD, with patients being treated in both trials. You may recall that on our fourth quarter conference call, we said that we expected the FDA to come back to us with comments on pivotal trial design amendments by March 20. We've now received comments for both the 005 and 006 trial designs.

謝謝你，史蒂夫。大家好，感謝您加入我們。在過去的這個季度，Compass Pathways 的 COMP360 III 期關鍵項目在難治性抑鬱症 (TRD) 方面繼續取得了巨大進展，患者在這兩項試驗中都得到了治療。您可能還記得，在我們第四季度的電話會議上，我們表示預計 FDA 將在 3 月 20 日之前向我們提供有關關鍵試驗設計修訂的評論。我們現在已經收到了針對 005 和 006 試驗設計的評論。

While I won't go into the details of our interactions with the FDA, I will say that the comments reflected an active and thoughtful dialogue. As you would expect, with a drug development program that has breakthrough designation, we will have ongoing engagement with the FDA more broadly over the whole course of the development program.

雖然我不會詳細介紹我們與 FDA 互動的細節，但我想說的是，這些評論反映了積極和深思熟慮的對話。正如您所期望的那樣，對於具有突破性指定的藥物開發計劃，我們將在整個開發計劃過程中與 FDA 進行更廣泛的持續接觸。

The upshot is that we are continuing to execute both the 005 and 006 trials, as described in our February conference call, and importantly, with no changes to the trial design. We also continue to expect top line results for the 6-week primary endpoint for 005 in summer of 2024, and for 006 in mid-2025.

結果是，我們將繼續執行 005 和 006 試驗，正如我們在 2 月份的電話會議中所描述的那樣，重要的是，試驗設計沒有改變。我們還繼續預計 005 的 6 週主要終點結果將在 2024 年夏季公佈，006 的 6 週主要終點結果將在 2025 年中期公佈。

On the reimbursement front, the American Medical Association has accepted a current procedural terminology, or CPT 3 code for psychodelic therapies. This was a very welcome development and the result of a collaboration between Compass Pathways and MAPS Public Benefit Corporation. Once effective, the CPT code will provide physicians of other qualified health care professionals with a means to track the work involved and ultimately seek reimbursement for delivering psychidetic therapies. Existing codes can provide coverage for the preparation and integration sessions, but the new code will fill a gap and cover psychological support during administration. The full details of the code are expected to be released by the AMA in July this year, and the code will go into effect when it's published on January 1, 2024.

在報銷方面，美國醫學會已接受當前的程序術語，即心理治療的 CPT 3 代碼。這是一個非常受歡迎的發展，也是 Compass Pathways 和 MAPS Public Benefit Corporation 合作的結果。一旦生效，CPT 代碼將為其他合格的醫療保健專業人員的醫生提供一種方法來跟踪所涉及的工作並最終尋求提供精神治療的報銷。現有的守則可以涵蓋準備和整合課程，但新守則將填補空白並涵蓋管理期間的心理支持。該準則的完整細節預計將於今年 7 月由 AMA 發布，該準則將於 2024 年 1 月 1 日發布後生效。

Currently, clinicians are forced to use various different codes coupled together to gain reimbursement for approved medicines that require observation or support during administration. This tracking code is a crucial step toward a single code that covers psychological support for therapies like COMP360, subject to FDA approval, and it's a critical step towards obtaining reimbursement. This helps enable broad and equitable access to psychedelic therapies. This ensures that FDA-approved psychedelic therapies could be integrated into health care systems, reimbursed by payers and made available to the people who need them.

目前，臨床醫生被迫使用各種不同的代碼組合在一起，以獲得在給藥期間需要觀察或支持的批准藥物的報銷。該跟踪代碼是邁向單一代碼的關鍵一步，該代碼涵蓋 COMP360 等療法的心理支持，需經 FDA 批准，也是獲得報銷的關鍵一步。這有助於實現迷幻療法的廣泛和公平的獲取。這確保了 FDA 批准的迷幻療法可以納入醫療保健系統，由付款人報銷並提供給有需要的人。

Finally, we've continued our active engagement with biotech specialist investors. We've continued to communicate the depth and the progress of our programs and the strength of our value creation proposition in an area of significant unmet medical need. Since the beginning of this year, we've raised roughly $28 million from sales under our ATM facility, including a large block trade in April.

最後，我們繼續與生物技術專業投資者積極接觸。我們繼續傳達我們項目的深度和進展，以及我們在重大未滿足醫療需求領域的價值創造主張的力量。自今年年初以來，我們已通過 ATM 設施的銷售籌集了大約 2800 萬美元，其中包括 4 月份的一筆大宗交易。

With that, let me now hand the call over to Dr. Guy Goodwin to provide further clinical updates.

現在，讓我將電話轉交給蓋伊·古德溫博士，以提供進一步的臨床更新。

Thank you, Kabir, and good day all. Let me begin with a review of our Compass-sponsored clinical program. In TRD, as you heard from Kabir, the Phase III program is progressing as planned, and we are actively treating patients in both trials. We are pleased with the rate of opening of clinical sites. This is a significant achievement as it's a complicated process to ensure that clinical sites are cleared to handle a Schedule 1 compound, are appropriately trained and can recruit suitable patients. This level of infrastructure is unprecedented and one that we believe represents a significant competitive advantage for Compass, both in this and future programs.

謝謝你，卡比爾，祝大家美好。讓我首先回顧一下我們的 Compass 贊助的臨床項目。在 TRD，正如您從 Kabir 那裡聽到的那樣，III 期項目正在按計劃進行，我們正在積極治療這兩項試驗中的患者。我們對臨床中心的開放率感到滿意。這是一項重大成就，因為這是一個複雜的過程，需要確保臨床場所能夠處理附表 1 化合物、接受適當的培訓並招募合適的患者。這種水平的基礎設施是前所未有的，我們認為無論是在本次項目還是未來的項目中，它都代表了 Compass 的顯著競爭優勢。

One site surpassed this stage, they are better able to concentrate on recruitment and patient management. I would, therefore, expect to see continued progress and acceleration on those fronts. Beyond treatment-resistant depression, or Phase II studies in PTSD and anorexia nervosa continue to progress well and are on track. In the anorexia nervosa study, we told you on our last call that we had encountered some challenges in getting patients into and through the screening process. I'm pleased to report that we are now making excellent progress after amending and adjusting our procedures to enable recruitment more in line with our expectations. We look forward to updating you on future calls regarding expected timing.

一個站點超越了這一階段，他們能夠更好地專注於招募和患者管理。因此，我希望看到這些方面不斷取得進展和加速。除了難治性抑鬱症之外，創傷後應激障礙 (PTSD) 和神經性厭食症的 II 期研究繼續取得良好進展，併步入正軌。在神經性厭食症研究中，我們在上次通話中告訴您，我們在讓患者進入並通過篩查過程方面遇到了一些挑戰。我很高興地向大家報告，在修改和調整我們的程序以使招聘更符合我們的期望之後，我們現在取得了良好的進展。我們期待在未來的電話會議中向您通報有關預計時間的最新情況。

Looking beyond our sponsored trials for investigator-led studies, we continue to see encouraging data coming from these programs. In March, data on the use of COMP360 with psychological support in 12 patients with treatment-resistant body dysmorphic disorder, or BDD, were published in the Journal of Psychiatric Research. Individuals with BDD are preoccupied by aspects of their appearance that they misperceive as defective or ugly. In this study of a single 25-milligram dose of COMP360, primary treatment effect was measured with the BDD y box score, which improved significantly over the 12 weeks of follow-up with a large effect size and significant changes from baseline seen at week 1, and persisting through week 12, the duration of the study.

除了我們贊助的研究者主導的研究試驗之外，我們繼續看到來自這些項目的令人鼓舞的數據。 3 月份，《精神病學研究雜誌》發表了 12 名難治性身體畸形障礙 (BDD) 患者在心理支持下使用 COMP360 的數據。患有 BDD 的人很關注自己的外表，認為這些方面有缺陷或醜陋。在這項單次 25 毫克劑量的 COMP360 的研究中，主要治療效果通過 BDD y box 評分進行測量，在 12 週的隨訪中顯著改善，效果較大，並且與第 1 週的基線相比發生了顯著變化，並持續到第 12 週，即研究的持續時間。

At week 12, 7 participants or 58% were considered responders. Secondary measures of BDD symptom severity, conviction of beliefs, depression, negative effects, psychological insight and disability, all similarly showed significant improvement. Tolerability and safety were evidenced by completion of all study visits by all participants and that no serious adverse events or occurrences of suicidal ideation were reported. The signals we see in this BDD study align with the hypothesis of difficult-to-treat disorders with preoccupying thoughts or fears represent potential target indications for COMP360 psilocybin therapy.

第 12 週時，有 7 名參與者（即 58%）被認為是有反應者。 BDD 症狀嚴重程度、信念信念、抑鬱、負面影響、心理洞察力和殘疾的次要指標也同樣顯示出顯著改善。所有參與者完成所有研究訪視，證明了耐受性和安全性，並且沒有報告嚴重不良事件或自殺意念的發生。我們在這項 BDD 研究中看到的信號與具有令人著迷的想法或恐懼的難以治療的疾病的假設相一致，代表了 COMP360 裸蓋菇素治療的潛在目標適應症。

This comes on the heel of another IIS we told you about in February that evaluated a single 25-milligram dose of COMP360 psilocybin therapy in 14 patients with type 2 bipolar depression, another condition for which treatment options are limited. This study produced very compelling data with 12 of 14 patients or 86% achieving remission at 12 weeks after administration without a resumption of antidepressant medication. It is this kind of information that these studies were designed to generate, understanding the potential of COMP360 in other indications with significant unmet need. These data sets also reinforce our confidence in our Phase III program. I would expect to see additional interesting data from studies as we move through this year.

在此之前，我們曾在 2 月份向您介紹過另一項 IIS，該項目評估了 14 名 2 型雙相抑鬱症患者的單次 25 毫克 COMP360 裸蓋菇素療法，這是另一種治療選擇有限的疾病。這項研究產生了非常令人信服的數據，14 名患者中有 12 名（86%）在給藥後 12 週內獲得緩解，無需恢復抗抑鬱藥物治療。這些研究旨在生成此類信息，了解 COMP360 在其他未滿足需求的適應症中的潛力。這些數據集也增強了我們對第三階段計劃的信心。我希望在今年的研究中看到更多有趣的數據。

I will now hand the call to Mike for the financial overview.

我現在將把電話轉給邁克，了解財務概況。

Thank you, Guy. I'll now recap our first quarter financial results. For the 3 months ended March 31, 2023, net loss was $24.2 million or $0.57 per share, including noncash share-based compensation of $4.1 million compared to net loss of $21.2 million or $0.50 per share, including noncash share-based compensation of $3.1 million for the 3 months ended March 31, 2022.

謝謝你，蓋伊。現在我將回顧一下我們第一季度的財務業績。截至 2023 年 3 月 31 日的三個月，淨虧損為 2420 萬美元，即每股 0.57 美元，包括 410 萬美元的非現金股份補償，而淨虧損為 2120 萬美元，即每股 0.50 美元，包括 310 萬美元的非現金股份補償截至2022年3月31日的三個月。

I will now turn to the analysis of the 3 months ended March 31, 2023 compared to the prior quarter ended December 31, 2022. For the 3 months ended March 31, 2023, net loss was $24.2 million or $0.57 per share compared with a net loss of $30.9 million or $0.73 per share for the 3 months ended December 31, 2022. These results include noncash share-based compensation of $4.1 million for the first quarter of 2023 and $3.3 million in the fourth quarter of 2022. Our first quarter financial results reflect our continued success in progressing our Phase III trial in treatment-resistant depression.

我現在將分析截至 2023 年 3 月 31 日的三個月與截至 2022 年 12 月 31 日的上一季度的比較。截至 2023 年 3 月 31 日的三個月，淨虧損為 2,420 萬美元，即每股 0.57 美元，而淨虧損為每股 0.57 美元。截至 2022 年 12 月 31 日的三個月虧損 3090 萬美元，即每股虧損 0.73 美元。這些業績包括 2023 年第一季度的非現金股份補償 410 萬美元和 2022 年第四季度的 330 萬美元。我們第一季度的財務業績反映了我們在治療難治性抑鬱症的 III 期試驗中持續取得的成功。

In line with our expectations, cash used in operations was $27.7 million, in the middle of the guidance range we provided last quarter. R&D expenses were $19 million in the 3 months ended March 31, 2023, compared with $19.8 million in the 3 months ended December 31, 2022.

與我們的預期一致，運營中使用的現金為 2770 萬美元，處於我們上季度提供的指導範圍的中間位置。截至2023年3月31日止的三個月，研發費用為1,900萬美元，而截至2022年12月31日止的三個月，研發費用為1,980萬美元。

The slight decrease was mainly caused by lower external development expenses due to the change in our Phase III design. This decrease was partially offset by increased personnel costs. G&A expenses were $12.8 million in the 3 months ended March 31, 2023, compared with $12.4 million in the 3 months ended December 31, 2022. This increase was due to increased personnel and legal costs, partially offset by decrease in facilities and other expenses.

略有下降主要是由於我們三期設計的變化導致外部開發費用減少。這一下降被人事成本增加部分抵消。截至2023年3月31日的三個月，一般及行政費用為1,280萬美元，而截至2022年12月31日的三個月，一般管理費用為1,240萬美元。這一增長是由於人員和法律成本的增加，部分被設施和其他費用的減少所抵消。

Our cash balance decreased by $26 million in the first quarter of 2023, due to using $27.7 million in operating cash, partially offset by $1.1 million provided by financing activities, due primarily to the sale of shares under our ATM facility and a change of $0.7 million due to exchange rate impacts. The movement in operating cash is primarily driven by our net loss, partially reduced by noncash charges.

2023 年第一季度，我們的現金餘額減少了 2600 萬美元，原因是使用了 2770 萬美元的運營現金，部分被融資活動提供的 110 萬美元所抵消，這主要是由於我們 ATM 設施下的股份出售和 70 萬美元的變化由於匯率影響。運營現金的變動主要是由我們的淨虧損驅動的，部分是由於非現金費用而減少的。

Regarding guidance, we expect the second quarter net cash used in operating activities to be between $22 million and $30 million, and the full year to be between $85 million and $110 million. The size of the second quarter range is due to the challenge in predicting the precise timing of cash outlays to support our Phase III program in its early stages. As the trial reaches steady state enrollment, we expect to offer a narrower quarterly and annual range.

關於指導，我們預計第二季度經營活動使用的淨現金將在 2200 萬美元至 3000 萬美元之間，全年將在 8500 萬美元至 1.1 億美元之間。第二季度範圍的規模是由於預測現金支出的精確時間以支持我們早期階段的第三階段計劃的挑戰。隨著試驗達到穩定的註冊人數，我們預計將提供更窄的季度和年度範圍。

Compass continues to maintain a strong financial position with cash and cash equivalents of $117.1 million at March 31, 2023, compared with $143.2 million at December 31, 2022. In addition to our first quarter cash balance, in the second quarter, we have received net proceeds of $26.9 million through the sale of shares under our ATM facility, which has further strengthened our cash position and extended our runway. We view our strong balance sheet as an important strategic asset, which we manage carefully as we invest to advance these promising potential therapies while at the same time continuing to create value for our shareholders.

Compass 繼續保持強勁的財務狀況，截至 2023 年 3 月 31 日，現金和現金等價物為 1.171 億美元，而截至 2022 年 12 月 31 日為 1.432 億美元。除了第一季度現金餘額外，第二季度我們還收到淨現金通過出售 ATM 設施下的股票獲得了 2690 萬美元的收益，這進一步增強了我們的現金狀況並延長了我們的發展空間。我們將強大的資產負債表視為重要的戰略資產，在投資推進這些有前途的潛在療法的同時，我們會謹慎管理資產負債表，同時繼續為股東創造價值。

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

謝謝。現在我將把電話轉回給卡比爾。

Thank you, Mike. In closing, let me say that now as a Phase III company, Compass Pathways leads the way in the development of psychedelic therapies. We believe these therapies represent the next generation of mental health therapeutic options. There's a significant and growing number of people across the world suffering from serious mental illness who are not helped by existing standards of care.

謝謝你，邁克。最後，我要說的是，現在作為一家 III 期公司，Compass Pathways 在迷幻療法的開發方面處於領先地位。我們相信這些療法代表了下一代心理健康治療選擇。世界各地有越來越多的人患有嚴重的精神疾病，但現有的護理標準卻無法幫助他們。

We must act with urgency on their behalf. Most programs in this area of science today are unproven, early stage and risky. We've established a high bar for evidence regarding safety and efficacy. Many of those early-stage clinical studies will likely fail to meet their primary endpoints, as we have seen with news from some other studies earlier this year.

我們必須為他們採取緊急行動。當今這一科學領域的大多數項目都未經證實、處於早期階段並且存在風險。我們對安全性和有效性的證據設定了很高的標準。正如我們從今年早些時候的其他一些研究的消息中看到的那樣，許多早期臨床研究可能無法達到其主要終點。

As Guy noted, we're progressing as expected in our Phase III program in treatment-resistant depression. While we ultimately expect to leverage our extensive data set to expand the development of COMP360 into a range of areas of unmet need, TRD is our first target indication, and our clear focus. To this end, we continue to advance our commercial strategy on a number of fronts as we move through the Phase III program towards an NDA submission with the FDA. The CPT 3 code, as discussed earlier, is a prime example of a successful step forward with our commercial approach and a clear indication that it can translate to significant value creation.

正如蓋伊所指出的，我們在難治性抑鬱症的第三階段項目中正在按預期取得進展。雖然我們最終希望利用我們廣泛的數據集將 COMP360 的開發擴展到一系列未滿足需求的領域，但 TRD 是我們的第一個目標適應症，也是我們明確的重點。為此，隨著我們通過第三階段計劃向 F​​DA 提交 NDA，我們將繼續在多個方面推進我們的商業戰略。如前所述，CPT 3 代碼是我們的商業方法成功向前邁出的一個主要示例，並明確表明它可以轉化為重大價值創造。

As Mike noted, we continue to be in a solid financial position with a strong balance sheet to help us advance these promising therapies. We are making strong, meaningful progress in our work to develop and deliver new therapeutic solutions to patients who suffer from difficult-to-treat mental health conditions.

正如邁克指出的那樣，我們繼續保持穩健的財務狀況和強大的資產負債表，以幫助我們推進這些有前途的療法。我們在為患有難以治療的心理健康問題的患者開發和提供新的治療解決方案的工作中取得了強有力的、有意義的進展。

Thank you again for your participation on today's call. We'll now turn to Q&A. So I'll hand it back to the operator.

再次感謝您參加今天的電話會議。我們現在轉向問答。所以我會把它交還給接線員。

(Operator Instructions) Our first question comes from the line of Elemer Piros from EF Hutton.

（操作員說明）我們的第一個問題來自 EF Hutton 的 Elemer Piros 系列。

Congratulations on putting in the temporary CPT code, Kabir. Maybe one question about that is how precedented or not having a code established 1 to 2 years before either MAPS or you are going to launch a secondary therapy? And maybe if you could contrast this to the situation with J&J's Spravato, which may have -- J&J may have not been as prepared as you may be.

恭喜您輸入臨時 CPT 代碼，Kabir。也許一個問題是，在 MAPS 或您要啟動輔助治療之前 1 到 2 年內建立代碼有什麼先例？也許如果你能將這與強生公司的 Spravo 的情況進行對比，強生公司可能沒有像你那樣做好準備。

And if you wouldn't mind comparing the treatment regimen with COMP360 to Spravato, especially considering that a patient would have to spend 8 times 2 hours in a clinic in the first month to receive that treatment. And just your take on J&J's first announcement of after, I think, 4 years of recording an annualized $500 million or so in revenue with that drug. I was wondering if you could provide a little comparison between the two.

如果您不介意將 COMP360 的治療方案與 Spravo 的治療方案進行比較，特別是考慮到患者在第一個月必須在診所呆 8 次，每次 2 小時才能接受該治療。我認為，強生公司在該藥物 4 年後的年收入約為 5 億美元左右，這是您對強生公司首次宣布的看法。我想知道您是否可以提供兩者之間的一些比較。

Thanks, Elemer, and I'll answer the question. Thank you for the question. And I think, yes, you raised a couple of very important points here around the CPT code. So I think, first, let's understand that, as I said, there are existing codes that account for preparation and integration, those fall within the normal range of psychotherapy sessions. But we recognized a long time ago that in terms of a 6- to 8-hour administration session. Or in the case of MAPS, multiple sessions of therapy associated with MDMA that there were not the appropriate codes to cover that. And it, therefore, became a priority for us working together to establish that.

謝謝，埃萊默，我會回答這個問題。感謝你的提問。我認為，是的，您在這裡圍繞 CPT 代碼提出了一些非常重要的觀點。因此，我認為，首先，讓我們了解，正如我所說，存在一些現有的規範來說明準備和整合，這些規範屬於心理治療課程的正常範圍。但我們很早以前就認識到這一點，即 6 至 8 小時的管理會議。或者就 MAPS 而言，與 MDMA 相關的多次治療沒有適當的代碼來涵蓋。因此，這成為我們共同努力實現這一目標的首要任務。

Recognize this is a CPT 3 code, but this enables physicians and other HCPs to track the work that's involved, the activities that are required, and it's really a central precursor to converting that ultimately into a CPT 1 code that can be reimbursed. And I think for Janssen, perhaps the recognition that the Spravato sessions under the REMS would require this monitoring period, which was different from anything else that was available at the time was something that came a little later in the process. And again, we're grateful to have had the opportunity to learn from that.

認識到這是 CPT 3 代碼，但這使醫生和其他 HCP 能夠跟踪所涉及的工作、所需的活動，並且它實際上是最終將其轉換為可報銷的 CPT 1 代碼的核心先驅。我認為對於 Janssen 來說，也許在 REMS 下的 Spravato 會議需要這個監控期（這與當時可用的任何其他監控期不同）的認識是在此過程中稍晚的時候發生的。再次，我們很高興有機會從中學習。

For the second part of your question, as you said, esketamine does require multiple administrations in the first month, and thereafter, regular intervals, and that's not surprising, given the relatively short duration of effect. Obviously, during our Phase III, we're going to generate evidence around durability, around the impact of retreatment, and that will give a sense also of when retreatment might be expected. But certainly, we saw from the Phase IIb a lasting effect for a significant number of patients even at 12 weeks, and we have some modest data that suggests it can go longer than that. So we would expect a much less frequent administration for COMP360 than you need to see for esketamine. And we believe that, that will also translate into a lower burden not only for patients critically, but also for providers and treatment centers as well.

對於你問題的第二部分，正如你所說，艾氯胺酮確實需要在第一個月內多次給藥，此後需要定期給藥，考慮到作用持續時間相對較短，這並不奇怪。顯然，在第三階段，我們將生成有關持久性和再處理影響的證據，這也將讓人了解何時可以進行再處理。但當然，我們從 IIb 期中看到，即使在 12 週內，對大量患者也產生了持久的影響，而且我們有一些適度的數據表明，它的持續時間可能會更長。因此，我們預計 COMP360 的給藥頻率比艾氯胺酮所需的頻率要低得多。我們相信，這不僅會減輕重症患者的負擔，也會減輕醫療服務提供者和治療中心的負擔。

And finally, yes, as you mentioned, Janssen broke out for the first time Spravato sales this year, a few years into the launch. Let's recognize that the launch did come just ahead of the pandemic, which put all sorts of challenges into pharmaceutical drug launches. But I think the fact that you saw over $100 million of sales in the U.S. in the first quarter with a strong growth trajectory is very encouraging for us, in a couple of different ways. It shows first that to fight some initial skepticism about the efficacy in clinical trials, physicians have become very used to working with esketamine and are actually seeing real-world evidence of efficacy that's perhaps patient acceptance that's strong.

最後，是的，正如您提到的，楊森今年在推出幾年後首次突破了 Spravo 的銷量。讓我們認識到，這次上市確實是在大流行之前發生的，這給藥品的上市帶來了各種各樣的挑戰。但我認為，第一季度美國銷售額超過 1 億美元，且增長軌跡強勁，這在幾個不同方面對我們來說非常令人鼓舞。它首先表明，為了消除一些最初對臨床試驗療效的懷疑，醫生已經非常習慣使用艾氯胺酮，並且實際上看到了現實世界的療效證據，這可能是患者強烈接受的。

I think critically, it speaks to the fact that the infrastructure has developed significantly since the launch, not just in terms of interventional psychiatry centers, and we've talked in the past about some of those stand-alone centers, but also in the fact that other psychiatry practices, other academic and hospital settings have become much more used to the fact that this is a treatment paradigm that's here to stay. And we would expect much of that infrastructure to be relevant to us at Compass for psilocybin as well. So overall, I think we take strong encouragement from that and the fact that they've identified that as a growth driver.

我批判性地認為，它說明了這樣一個事實：自啟動以來，基礎設施已經取得了顯著的發展，不僅僅是在介入精神病學中心方面，我們過去討論過其中一些獨立中心，而且在事實上其他精神病學實踐、其他學術和醫院環境已經更加習慣了這樣一個事實：這是一種將繼續存在的治療範式。我們預計這些基礎設施的大部分也與我們 Compass 的裸蓋菇素相關。總的來說，我認為我們從這一點以及他們已將其視為增長動力的事實中得到了強烈的鼓勵。

And at what point -- I know it's too early in the launch, but at what point would you be able to project enrollment rates? And for now, you reiterated the previous guidance for completion of both of those -- both of the pivotal trials. Shall we expect that towards the end of this year? Or when you have a little more confidence on the trajectory?

我知道在什麼時候啟動還為時過早，但在什麼時候您才能預測入學率？現在，您重申了之前完成這兩項關鍵試驗的指導。我們應該期待今年年底嗎？或者當你對軌跡更有信心時？

Yes, it's a fair question, Elemer. I would just say, definitely not yet, and I don't want to give a commitment to when we would do that. I mean, as I said, we have patients dosed in both trials. As Guy mentioned, the fact that we are well on the way to building the trial infrastructure with more sites coming on board and so on is very encouraging. But I don't want to promise a date of which we will actually give enrollment numbers or percentages enrolled. But for now, given where we are, we are confident as we did in reiterating those timings for the primary endpoints.

是的，這是一個公平的問題，埃萊默。我只想說，絕對還沒有，而且我不想承諾我們何時會這樣做。我的意思是，正如我所說，我們在這兩項試驗中都對患者進行了給藥。正如蓋伊提到的，我們正在建設試驗基礎設施，更多站點加入等等，這一事實非常令人鼓舞。但我不想承諾我們將實際提供入學人數或入學百分比的日期。但就目前而言，考慮到我們所處的情況，我們有信心，就像我們重申主要終點的時間安排一樣。

Our next question will come from the line of Charles Duncan from Cantor.

我們的下一個問題將來自康托爾的查爾斯鄧肯。

Congrats on the progress. I did have a question regarding the ongoing Phase IIIs. So maybe you're not going to be able to answer them. But I'm wondering if you could provide more color on the FDA interactions. You said they are active, thoughtful dialogue. But I guess I'm assuming no modification in the primary or secondary endpoints. And then perhaps if Guy could speak to the pacing of the trial, great to see that you've made some progress in terms of patient enrollment. But I'm wondering if the biggest, call it, rate limiter for this trial is site opening, or is it patient access and availability of appropriate patients?

祝賀取得的進展。我確實對正在進行的第三階段有疑問。所以也許你無法回答他們。但我想知道您是否可以提供有關 FDA 相互作用的更多信息。你說他們是積極的、深思熟慮的對話。但我想我假設主要或次要終點沒有改變。然後，也許蓋伊可以談談試驗的節奏，很高興看到您在患者入組方面取得了一些進展。但我想知道該試驗最大的速率限制因素是否是站點開放，或者是患者的准入和合適患者的可用性？

Thanks, Charles. I'll actually ask Guy to take both of those parts, if that's okay.

謝謝，查爾斯。如果可以的話，我實際上會要求蓋伊承擔這兩部分。

Yes. We -- as you know, Charles, there's no change in primary outcomes, and there's no fundamental change in the design of the studies as a result of our to and fro with the agency. We're well on track as far as we're concerned with recruitment at the moment.

是的。正如你所知，查爾斯，由於我們與該機構的反复溝通，主要結果沒有變化，研究設計也沒有根本性變化。目前我們在招聘方面進展順利。

You asked an interesting question because it falls into different phases of the studies. At the beginning, the limiting step is simply a site initiation. That takes time. It takes things to happen, which are quite beyond anyone's -- well, beyond the control of us and of the investigators, which are things like EMA licenses.

你問了一個有趣的問題，因為它屬於研究的不同階段。一開始，限制步驟只是站點啟動。這需要時間。這需要一些事情發生，這遠遠超出了任何人的控制範圍——嗯，超出了我們和調查人員的控制範圍，比如 EMA 許可證。

We are obviously plotting and we have modeled the rate at which patients will be recruited. And I would simply say that as far as our simulations of the future go and as far as we can be confident in the way we've achieved openings so far, we're looking very good. Obviously, we expect that once all the sites are open, then there will be different considerations around what limits recruitment, but we anticipate the demand for entry into the studies to be unusually positive for most -- compared to most depression studies. And we know from feedback we had from the sites that it's certainly true in some centers.

顯然，我們正在策劃，並且我們已經對招募患者的速度進行了建模。我只想說，就我們對未來的模擬而言，以及我們對迄今為止實現的開放方式充滿信心，我們看起來非常好。顯然，我們預計，一旦所有網站都開放，那麼對於限制招募的因素將會有不同的考慮，但我們預計，與大多數抑鬱症研究相比，對大多數人來說，進入研究的需求將異常積極。從網站的反饋來看，我們知道在某些中心確實如此。

So we look forward to seeing the results of that, and we'll be tracking it very carefully. And of course, it's the key metric for us over the next 12 months to see that rise in recruitment curve, and we're happy that we'll be able to do that and give you some indication of our happiness with it, but we're going to be careful about numbers because they can be misleading and they can be misunderstood.

因此，我們期待看到結果，並且我們將非常仔細地跟踪它。當然，這是我們在未來 12 個月看到招聘曲線上升的關鍵指標，我們很高興能夠做到這一點，並向您展示我們對此的滿意度，但我們我們會謹慎對待數字，因為它們可能會產生誤導，並且可能會被誤解。

Yes, absolutely fair on that and appreciate it. Regarding anorexia nervosa, booster quite intrigued with that. Happy to hear that it's kind of back on track. Can you provide any additional information on the actual amended procedures or how they were amended or what is perhaps change of vector on that trial versus last quarter?

是的，這絕對公平，並對此表示讚賞。關於神經性厭食症，Booster 對此非常感興趣。很高興聽到它又回到了正軌。您能否提供有關實際修訂程序或如何修訂這些程序的任何其他信息，或者該試驗與上季度相比可能有哪些變化？

They were quite minor amendments to the protocol. I mean, unfortunately, that takes time. They were really to do with the visit burden on patients and just the preparedness of patients to participate in the study. You'll appreciate that randomized clinical trials are not like ordinary practice. They place unusual demands on the subjects you participate, and I think that the need for in-person visits, in particular, was something that was too demanding in the initial stages, and we felt no reason for not changing because it didn't materially affect how the study would run or the results. So it's been a simplification of the trial design. It's not a fundamental change in the actual objectives or the questions that it will answer.

它們只是對協議的微小修改。我的意思是，不幸的是，這需要時間。它們實際上與患者的就診負擔以及患者參與研究的準備有關。您會發現隨機臨床試驗與普通實踐不同。他們對你參與的主題提出了不尋常的要求，我認為，特別是親自參觀的需要，在最初階段是太苛刻的，我們覺得沒有理由不改變，因為它沒有實質性的改變。影響研究的進行方式或結果。所以這是試驗設計的簡化。這並不是實際目標或它將回答的問題的根本改變。

Okay. That's helpful. Last question for Mike. Quickly on the ATM that was noted a large block trade, you may not be able to fully answer this, but I'm wondering if you could characterize the investor, obviously, not a certain identity, but maybe in investing type or whether or not they had previously held a position. Any additional information that you could provide there.

好的。這很有幫助。邁克的最後一個問題。快速在 ATM 上註意到大宗交易，您可能無法完全回答這個問題，但我想知道您是否可以描述投資者的特徵，顯然，不是某個身份，但可能是投資類型或是否他們之前曾擔任過職務。您可以在那裡提供的任何其他信息。

So because the investment came in through the ATM, I am a little bit limited on the information that I can provide. I would point out that if you go back and look at trading volumes earlier in the quarter, it's pretty clear when that happens and the size of it. And I can characterize the investor.

因此，由於投資是通過 ATM 機進入的，所以我能提供的信息有點有限。我想指出的是，如果你回頭看看本季度早些時候的交易量，就會很清楚這種情況發生的時間和規模。我可以描述投資者的特徵。

We've spoken on prior calls that we've been working pretty intensively to bring biotech specialists, sophisticated investors into the register, not only to support us with our current financing needs, but investors who are going to understand the fact that we're going to be coming back additionally in the future as we get closer to commercialization and as we build for a successful launch. So those conversations continue, and we continue to make progress. And I'd say that this investor would fall into that realm of the investing universe that we've been working closely with.

我們在之前的電話會議上表示，我們一直在努力將生物技術專家、經驗豐富的投資者納入登記冊，不僅是為了支持我們當前的融資需求，也是為了讓投資者了解我們正在隨著我們越來越接近商業化以及我們為成功發布而努力，我們還會在未來再次回歸。因此，這些對話仍在繼續，我們將繼續取得進展。我想說，這位投資者將屬於我們一直密切合作的投資領域。

That makes sense. Sequentially funding the company I've seen with other neuro innovators, so it should work here, too.

這就說得通了。我見過其他神經創新者相繼為這家公司提供資金，所以它在這裡也應該有效。

Our next question comes from the line of Frank Brisebois from Oppenheimer.

我們的下一個問題來自奧本海默的弗蘭克·布里斯博伊斯（Frank Brisebois）。

Just in terms of the reimbursement, can you just -- we -- in a prior question, Spravato was brought up quite a bit. And I'm just wondering, Spravato, for those that might not be aware, what coding do they use? Is it -- this G code that -- is that -- like how different is that from a CPT I? And just maybe understanding for investors here, the difference here between the G code, CPT I and CPT III, and then maybe what kind of additional color could we be expecting in July here?

就報銷而言，您能否——我們——在之前的問題中，Spravo 被提到了很多。我只是想知道，Spravoto，對於那些可能不知道的人來說，他們使用什麼編碼？這個 G 代碼與 CPT I 有何不同？也許投資者可以了解 G 代碼、CPT I 和 CPT III 之間的區別，然後也許我們可以在 7 月份期待什麼樣的額外顏色？

Yes. Thank you, Frank. It's a great question. So the first thing I will say is since we're -- these codes are only going to be published in July, we're actually not going to talk in very much detail about what we expect to see or what they will actually cover until after that because the AMA would not like us to do so.

是的。謝謝你，弗蘭克。這是一個很好的問題。所以我要說的第一件事是，因為我們 - 這些代碼只會在 7 月份發布，所以我們實際上不會詳細討論我們期望看到的內容或它們實際上將涵蓋的內容，直到之後因為 AMA 不希望我們這樣做。

I think what I would focus on is what we have done here, which is acknowledging that, for psilocybin specifically, the 6- to 8-hour administration is a unique model of psychological support for which nothing existed, and the idea of stringing together multiple codes to do that would clearly be unappealing to providers, not necessarily feasible, but also will not give any consistency. That's the reason that we actually focus there for obtaining this code.

我想我要重點關注的是我們在這裡所做的事情，即承認，特別是對於裸蓋菇素而言，6 至 8 小時的給藥是一種獨特的心理支持模式，目前還不存在這種模式，並且將多種方法串聯在一起的想法這樣做的代碼顯然對提供商沒有吸引力，不一定可行，而且也不會提供任何一致性。這就是我們實際上專注於獲取此代碼的原因。

I think what Janssen is doing is using a variety of different codes. It is a different model of support, as you're aware. It is post-administration monitoring as opposed to support during administration, and they have been able to use a number of different codes. I think more, we would like to hold to after the summer when we talk more about the CPT code and then get into some of the different mechanisms for payment because, obviously, there are some areas where we're seeing bundled payments across drug and provision of services, some areas where we're seeing MAPS separating. And I think we're very happy to get into more discussion around that once the details of the code are out and published.

我認為詹森正在做的是使用各種不同的代碼。如您所知，這是一種不同的支持模式。這是管理後監控，而不是管理期間的支持，並且他們已經能夠使用許多不同的代碼。我想更多的是，我們希望在夏天之後繼續討論 CPT 代碼，然後討論一些不同的支付機制，因為顯然，在某些領域我們看到了藥物和藥物的捆綁支付。服務的提供，我們看到 MAPS 正在分離的一些領域。我認為，一旦代碼的詳細信息發布並發布，我們很高興能就此展開更多討論。

Our next comes from the line Joshua Schimmer from Evercore ISI.

我們的下一個來自 Evercore ISI 的 Joshua Schimmer。

For -- just going back to the CPT codes. They go into effect January 1, that means that is when the resource consumption analysis will begin. And over what time does that occur? And when do final codes and reimbursement likely go into place? And then if it's going to be done for both MAPS and Compass, how do the codes reconcile differences between the resource consumption that exist between the 2 products?

回到 CPT 代碼。它們於 1 月 1 日生效，這意味著資源消耗分析將從那時開始。這種情況會在什麼時間發生？最終代碼和報銷可能什麼時候到位？然後，如果要對 MAPS 和 Compass 執行此操作，代碼如何協調這兩種產品之間存在的資源消耗差異？

Thanks, Josh, for the question. So on the latter part, once we see details of the code, I think that will make it clear some of the answers to the second part of the question. For the first part, there is no fixed time line from which a CPT III code grows up, shall we say, to become a CPT I code. What happens is that from January 1, it will be available to be used for tracking activities. And what's important is that there is adoption, that there is good experience, but also that the data that we continue to generate through the trials, the data that MAPS may start to generate in the real world supports strong evidence of efficacy and so on.

謝謝喬希的提問。因此，在後一部分中，一旦我們看到代碼的詳細信息，我認為這將使問題第二部分的一些答案變得清晰。對於第一部分，CPT III 代碼成長為 CPT I 代碼並沒有固定的時間線。從 1 月 1 日起，它將可用於跟踪活動。重要的是，有採用，有良好的經驗，而且我們通過試驗繼續生成的數據，MAPS 可能開始在現實世界中生成的數據支持強有力的功效證據等等。

And again, there is a process of building that body of evidence, as you say, starting to actually -- the value elements of it, but there is no fixed time frame for this becoming reimbursable. Obviously, by doing this well in advance, we may be able to launch, it is our hope and expectation that we will be able to have something that is reimbursable at or very close to launch, but that's going to depend on continuing efforts by us, by MAPS and potentially others from January of next year.

再說一次，正如你所說，有一個建立證據體系的過程，實際上開始——它的價值要素，但沒有固定的時間框架讓這成為可償還的。顯然，通過提前做好這件事，我們也許能夠推出，我們希望和期望我們能夠在推出時或即將推出時獲得可償還的東西，但這將取決於我們的持續努力，由 MAPS 以及其他可能從明年 1 月開始的公司提供。

Okay. Got it. And then now that you've seen an uptick in enrollment in the anorexia trial, when do you expect to be in a position to report data?

好的。知道了。既然您已經看到厭食症試驗的註冊人數有所增加，您預計什麼時候能夠報告數據？

I think, to be honest, that we base this on a recruitment curve. We're still at the stage of developing that curve to see where it will saturate where we'll get to the required numbers. So it would be premature to give a date just at this minute. But we're confident that we're on track to complete this study, and the exact timing we will release when we are more confident about it.

老實說，我認為我們這是基於招聘曲線。我們仍處於開發該曲線的階段，看看它會在哪裡飽和，從而達到所需的數字。因此，現在就給出日期還為時過早。但我們有信心我們正在按計劃完成這項研究，當我們對此更有信心時，我們將發布確切的時間。

Our next question comes from the line of Patrick Trucchio from H.C. Wainright.

我們的下一個問題來自 H.C. 的 Patrick Trucchio。溫賴特。

Just a quick follow-up on the potential commercialization as we look ahead to the potential commercialization of COMP360, I'm wondering if you can frame for us what a potential REMS program could entail? And if it would be similar to Spravato or would there be some important differences we should be aware of? And how could this in some way help streamline the launch of COMP360?

當我們展望 COMP360 的潛在商業化時，我想快速跟進一下潛在的商業化，我想知道您是否能為我們描述一下潛在的 REMS 計劃可能需要哪些內容？如果它與 Spravo 相似，或者是否有一些我們應該注意的重要差異？這如何在某種程度上幫助簡化 COMP360 的發布？

Thanks, Patrick. I mean, I guess, it's a little premature to speculate on the shape of the REMS. But there's also, to a large extent, that will follow the label and what's in the label in terms of what's in the REMS. But yes, I think we need to be clear that we do expect the REMS with -- I also would expect the key element being the (inaudible), the elements to assure safe use. Those are clearly going to require, I would expect, essentially, distribution through specialist pharmacies to treatment centers for a given patient with the indication that's still unclear, it will require physician certification, patient certification and so on. Beyond that, in terms of the scope and what we may end up negotiating with the FDA around the actual elements, honestly, I think it's premature.

謝謝，帕特里克。我的意思是，我想現在推測 REMS 的形狀還為時過早。但在很大程度上，這將遵循標籤和標籤中的內容，以及 REMS 中的內容。但是，是的，我認為我們需要明確的是，我們確實期望 REMS 具有——我也期望關鍵要素是（聽不清），即確保安全使用的要素。我預計，這些顯然需要通過專業藥房向治療中心分發給特定患者，但其適應症仍不清楚，這將需要醫生認證、患者認證等。除此之外，就範圍以及我們最終可能與 FDA 圍繞實際要素進行談判的內容而言，老實說，我認為現在還為時過早。

Yes. That's really helpful. And then I'm just wondering if you can talk about the level of interest or acceptance in psychedelic therapy, specifically among the neuropsych key opinion leaders and clinical trial investigators. How have these views change, particularly as we had more data published, including from the COMP360 Phase IIb trial? And how do you view this evolution as progressing as we approach the Phase III readout next year for COMP360?

是的。這真的很有幫助。然後我想知道您是否可以談談對迷幻療法的興趣或接受程度，特別是神經心理學關鍵意見領袖和臨床試驗研究人員。這些觀點有何變化，特別是當我們發布了更多數據（包括來自 COMP360 IIb 期試驗的數據）時？隨著我們明年即將進入 COMP360 的 III 期試驗，您如何看待這一演變？

Thanks, Patrick. I think it's -- within the academic side, there's a certain -- there's a mixture. Some people still think that the commercialization will be difficult. But in a sense, it's not university sites' opinion that's really going to matter in that. It's really to do with the kind of relationships we build with more commercial providers. So I think that the impressions I get certainly are, there's great enthusiasm for the idea, and there's really very little pushback on our interpretation of the data.

謝謝，帕特里克。我認為——在學術方面，有一定的——有一種混合。一些人仍然認為商業化會很困難。但從某種意義上說，真正重要的並不是大學網站的觀點。這實際上與我們與更多商業提供商建立的關係有關。所以我認為我得到的印象肯定是，人們對這個想法抱有極大的熱情，而且我們對數據的解釋幾乎沒有受到任何阻力。

The enthusiasts for this area think it's going to be great and are really positive about it. But we have to recognize that many of the sites who are doing the trials are not necessarily all going to be commercially active. But I think overall, the feeling is that there's a lot of enthusiasm within the profession for this approach. And there's a lot of acceptance that there needs to be changes to allow it to happen. And I think that's very important.

該領域的愛好者認為它會很棒並且對此非常積極。但我們必須認識到，許多正在進行試驗的網站不一定都具有商業活躍性。但我認為總體而言，業內人士對這種方法抱有很大的熱情。人們普遍認為需要做出改變才能實現這一目標。我認為這非常重要。

And I think the final thing is that this is going to be an opportunity for patients who are not currently receiving adequate treatment actually to get it, because I think there's going to be a move to not leave people primary care, inadequately treated, not receiving the kind of additional treatments that sometimes work. And this will provide a traction, I think, for getting those sort of patients who are currently not being treated into treatment. And I think a lot of psychiatrists recognize that, and we'll certainly be -- as we go forward, we'll be driving along with the key opinion leaders that particular message that this is an area that is not only failure of treatment but really not offering adequate treatment to people.

我認為最後一件事是，對於目前沒有接受足夠治療的患者來說，這將是一個真正獲得治療的機會，因為我認為將會採取行動，不讓人們接受初級保健、治療不充分、不接受治療。有時有效的額外治療方法。我認為，這將為那些目前未接受治療的患者提供治療的動力。我認為很多精神病學家都認識到這一點，而且我們肯定會——隨著我們的前進，我們將與關鍵意見領袖一起推動這一特定信息，即這個領域不僅治療失敗，而且確實沒有為人們提供足夠的治療。

And I would just add, we're starting to engage with regional health systems, not necessarily household names, not the big ones you've heard of, but regional health systems that are seeing significant numbers of patients that are already offering TMS, Spravato, in some cases, ECG, and the level of excitement there and interest is extremely high. They are very interested to see how they can add this as another option for certain patients, both existing patients who are not benefiting from current treatments, but also as Guy said, extending it to other patients. So again, early days. Obviously, we don't want to go too fast with that. But we are, as I say, starting to engage with a number of those and getting a lot of very positive feedback.

我想補充一點，我們開始與地區衛生系統合作，不一定是家喻戶曉的名字，也不是你聽說過的大公司，而是那些已經有大量患者提供 TMS、Spravato 的地區衛生系統，在某些情況下，心電圖顯示，那裡的興奮程度和興趣是極高的。他們非常有興趣了解如何將其添加為某些患者的另一種選擇，這些患者既沒有從當前治療中受益，也如蓋伊所說，將其擴展到其他患者。再說一次，早期。顯然，我們不想走得太快。但正如我所說，我們正在開始參與其中的一些工作，並得到了很多非常積極的反饋。

Next question comes from the line of Ritu Baral from Cowen.

下一個問題來自 Cowen 的 Ritu Baral。

About the CPT code, can you clarify when the information gathering for resource utilization exactly begins? Kabir, I think you and I have talked about this, and I believe it covers the administration session, but I'm wondering, is there a possibility that it might capture the prep session? Would you want to create a different CPT code for that prep session? Or do you think -- and the consolidation session? Or do you think that existing codes would cover prep and consolidation? And the I have a follow-up.

關於CPT代碼，您能否澄清一下資源利用信息收集的具體開始時間？卡比爾，我想你和我已經討論過這個問題，我相信它涵蓋了管理會議，但我想知道，它是否有可能捕獲准備會議？您想為該準備課程創建不同的 CPT 代碼嗎？或者您認為——以及鞏固會議？或者您認為現有的代碼會涵蓋準備和整合嗎？我有一個後續行動。

Thanks, Ritu. So yes, our belief is that existing codes can follow, can support preparation and integration. And the need, the gap was code or codes that could cover the administration. I think it's also important to acknowledge, obviously, in a trial setting, it is the same therapies for preparation and administration and integration.

謝謝，瑞圖。所以，是的，我們相信現有的規範可以遵循，可以支持準備和集成。需要、差距是可以涵蓋管理的代碼或代碼。我認為同樣重要的是要承認，顯然，在試驗環境中，準備、給藥和整合的療法是相同的。

In a real-world commercial setting, you could well see that a patient may have an existing relationship with a therapist who would actually be involved in the preparation and integration sessions, and the support required during the administration will come from a different provider, and thats the model, we may well see emerge. So in that context as well, our focus really was on the novel piece, the gap that existed for this expected administration.

在現實世界的商業環境中，您很容易看到患者可能與治療師有現有的關係，治療師實際上會參與準備和整合會議，並且管理期間所需的支持將來自不同的提供者，並且這就是模型，我們很可能會看到出現。因此，在這種情況下，我們的重點實際上是在新穎的作品上，即本屆預期政府中存在的差距。

So it's just CPT code will just be the administration session from the start.

因此，從一開始，CPT 代碼就只是管理會話。

Again, let's wait for July and see the details of it. It's actually 3 codes, not just 1. We can't go into any more detail now, but let's wait for that and see. And in terms of when it can start, as we said, it's the 1st of January '24. So that's the point for which people can start to use this code to track activities, to track what's actually happening during these sessions.

再次，讓我們等待七月，看看它的細節。它實際上是 3 個代碼，而不僅僅是 1 個。我們現在無法詳細說明，但讓我們拭目以待。至於何時開始，正如我們所說，是 24 年 1 月 1 日。因此，人們可以開始使用此代碼來跟踪活動，跟踪這些會話期間實際發生的情況。

Understood. And then just maybe anorexia, you mentioned changes from both enrollment because of challenges in patients through screening. Can you just drive some of those changes to the protocol? And do you believe that how you plan changes will result in changes in the patient population (inaudible) projected.

明白了。然後可能是厭食症，您提到了由於患者篩查面臨的挑戰而導致兩次入組的變化。您能否對協議進行一些更改？您是否相信您計劃的改變將導致預計的患者群體（聽不清）發生變化。

Thanks, Ritu. I don't think it will change in patient population because this is a fairly defined condition, as I'm sure you know. I mean the issues really were around patient burden and participation in the study. And I guess we had assumed that the patients will be more tolerant of that, leading from our experience with TRD. And I think, simply, many of the patients with anorexia nervosa are more ambivalent about treatment. And so that additional burden, I think, may have served as a barrier. By burden, I simply mean having to turn up for multiple visits in person, which were not strictly necessary, but in a sense, were simply put down because that is the way we had previously done studies and there is a tendency to trust in face-to-face assessments more than remote ones.

謝謝，瑞圖。我認為患者群體不會發生變化，因為這是一個相當明確的情況，我相信您知道。我的意思是，問題實際上與患者負擔和研究參與有關。我想，根據我們在 TRD 方面的經驗，我們假設患者會更能容忍這一點。我認為，簡單來說，許多神經性厭食症患者對治療更加矛盾。因此，我認為額外的負擔可能成為了障礙。我所說的負擔，只是指必須親自進行多次訪問，這並不是絕對必要的，但從某種意義上說，只是被擱置了，因為這是我們以前進行研究的方式，並且存在信任面子的傾向面對面評估多於遠程評估。

There's no real reason to do that when someone is not dealing with the primary outcomes. And therefore, we modified the protocol to allow more remote assessment. We don't think that reduces the quality of the information we will get materially. It doesn't change the outcomes. And the key measurements of outcome will remain in person, and therefore, will be the same as originally planned.

當某人不處理主要結果時，就沒有真正的理由這樣做。因此，我們修改了協議以允許更遠程的評估。我們認為這不會實質性地降低我們獲得的信息的質量。它不會改變結果。結果的關鍵衡量標準將保留在現場，因此將與最初計劃的相同。

So the changes are relatively modest, but they may make a surprising difference, and we will obviously hope that they do and keep you updated on when they do.

因此，這些變化相對較小，但它們可能會產生令人驚訝的變化，我們顯然希望它們能夠做到這一點，並讓您及時了解最新情況。

Our next question will come from the line of Nina Bitritto-Garg from Citi.

我們的下一個問題將來自花旗銀行的 Nina Bitritto-Garg。

I remember last time on the last earnings call, you mentioned the addition of Part B and Part C to both Phase III TRD studies. And I was just wondering if you could share at this point what the retreatment criteria are in those 2 parts? I know Part B, I think, has optional retreatment. And then Part III, I believe, is based on a relapse. So can you just provide us with the actual criteria for both of those, that would be great.

我記得上次在上次財報電話會議上，您提到在兩項 III 期 TRD 研究中添加了 B 部分和 C 部分。我只是想知道您現在是否可以分享一下這兩部分的再治療標準是什麼？我知道 B 部分有選擇性的再治療。我相信，第三部分是基於舊病復發。那麼您能否向我們提供這兩者的實際標準，那就太好了。

Yes. I mean, the criteria for retreatment are essentially that patients have a (inaudible) above a threshold, and that threshold will be a threshold of 20 on the total score.

是的。我的意思是，再治療的標準本質上是患者的（聽不清）高於閾值，並且該閾值將是總分的閾值 20。

Okay. And it's the same in both Part B and Part C?

好的。 B部分和C部分是一樣的嗎？

It's the same in both parts, yes.

兩部分都是一樣的，是的。

Our next question comes from the line of Sumant Kulkarni from Canaccord.

我們的下一個問題來自 Canaccord 的 Sumant Kulkarni。

So in the past, you've said that there would be no interim analysis for COMP005, is that still the case? And if there is no interim analysis, do you plan to provide any efficacy updates on a blinded basis? And when could one expect those relative to the top line data in summer of 2024?

那麼您過去說過COMP005不會進行中期分析，現在還是這樣嗎？如果沒有中期分析，您是否計劃在盲法的基礎上提供任何療效更新？相對於 2024 年夏季的頂線數據，人們什麼時候可以預期這些數據？

Sumant, I think your question was, do we plan an interim analysis, and the answer remains no. And no, we should not expect to know anything before summer of 2024.

Sumant，我認為你的問題是，我們是否計劃進行中期分析，答案仍然是“否”。不，我們不應該期望在 2024 年夏天之前知道任何事情。

Got it. And then could you specifically compare the in-person support services during psychedelic therapy that may be needed for COMP360 versus MAPS, which is specifically characterized as MDMA-assisted therapy. Obviously, these are different treatments and indications, but I'm trying to get a relative sense of the reimbursement burden.

知道了。然後，您能否具體比較 COMP360 與 MAPS 可能需要的迷幻治療期間的現場支持服務，後者的特點是 MDMA 輔助治療。顯然，這些是不同的治療方法和適應症，但我試圖對報銷負擔有一個相對的認識。

So let me start, and Guy may jump in. I mean, so a psilocybin session, as we know, consists of -- for a patient, there is preparation, there is the actual administration session itself, which is 6 to 8 hours, and there is integration.

讓我開始吧，蓋伊可能會插話。我的意思是，正如我們所知，裸蓋菇素療程包括——對於患者來說，有準備工作，有實際的給藥療程本身，即 6 到 8 小時，並且存在整合。

As you know, in Phase IIb, we studied 1 dose. In the Phase III, we have both the 2-dose study in the core part of the protocol as well as the single dose. But as just referenced, we do have an option for retreatment on relapse or failure to remit in Part B and then again in Part C. So that is kind of the burden for us from a psilocybin perspective. The MDMA protocol from recollection is 12 therapy sessions, including 3 doses of MDMA, I think.

如您所知，在 IIb 期，我們研究了 1 劑。在第三階段，我們在方案的核心部分既有2劑研究，也有單劑研究。但正如剛才提到的，我們確實可以選擇在 B 部分中復發或未能緩解時進行再治療，然後在 C 部分中再次治療。因此，從裸蓋菇素的角度來看，這對我們來說是一種負擔。我記得 MDMA 方案是 12 次治療，其中包括 3 劑 MDMA。

That's correct. Yes. I think the interactions that take place on the therapy days with the drug are quite intense. The drug is sometimes described as producing greater empathy and therefore, more communication with treating people. That contrasts with psilocybin where on the day of administration, at the doses we are using, 25 milligrams, the patients are essentially inwardly guided. They're not interacting with the therapist. And in fact, the therapists are instructed not to interact with the patients other than to help them to, in a sense, remain focused on their internal journey work that they usually use.

這是正確的。是的。我認為在治療期間與藥物發生的相互作用非常強烈。有時，這種藥物被描述為能產生更大的同理心，從而與治療者進行更多的溝通。這與裸蓋菇素形成鮮明對比，在給藥當天，我們使用的劑量為 25 毫克，患者基本上受到內心的引導。他們沒有與治療師互動。事實上，治療師被指示不要與患者互動，只是在某種意義上幫助他們繼續專注於他們通常使用的內部旅程工作。

So there's a great difference in the way we should be thinking about the role of psychotherapy. Psychotherapy is a key part of the MDMA treatment. It is not a key part of psilocybin treatment. And that's why we have used the term psychological support, where the emphasis is really on safety and safeguarding, and it is not on essentially a treatment of a psychotherapeutic client.

因此，我們思考心理治療作用的方式應該有很大的不同。心理治療是搖頭丸治療的關鍵部分。它不是裸蓋菇素治療的關鍵部分。這就是為什麼我們使用心理支持這個術語，它的重點實際上是安全和保障，而不是本質上對心理治療客戶的治療。

Understood. And once the CPT III code goes live in 2024, is there any potential for approved but off-label products ability to utilize this code for therapy sessions?

明白了。一旦 CPT III 代碼於 2024 年生效，已批准但標籤外產品是否有可能利用該代碼進行治療？

It's a good question. I guess at the discretion of the provider, yes. But I'm actually not entirely sure.

這是一個好問題。我想是的，由提供商自行決定。但我實際上並不完全確定。

And with no further questions in the queue, I'd like to turn the call back over to management for any closing remarks.

由於隊列中沒有其他問題，我想將電話轉回管理層以供結束語。

Thank you very much. So once again, thank you, everyone, for your participation, and thank you for the questions as well. Just a reminder, we are making excellent progress on our Phase III trials for treatment-resistant depression as well as continuing to build the body of evidence for COMP360 more generally. We're excited, obviously, about the CPT III code. We're excited about the validation you see from Spravato as well in terms of momentum, and we believe we're also making strong strides towards demonstrating commercial value proposition for COMP360. So thanks, everyone. Have a good rest of the day.

非常感謝。再次感謝大家的參與，也感謝大家提出的問題。提醒一下，我們在難治性抑鬱症的 III 期試驗中取得了巨大進展，並繼續為 COMP360 建立更廣泛的證據。顯然，我們對 CPT III 代碼感到興奮。我們對您從 Spravo 看到的驗證以及動力方面感到興奮，我們相信我們也在展示 COMP360 的商業價值主張方面取得了強勁的進展。謝謝大家。好好休息一天吧。

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a good day.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。大家，祝你有美好的一天。