Compass Pathways PLC (CMPS) 2023 Q2 法說會逐字稿

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

女士們、先生們，美好的一天，歡迎參加 COMPASS Pathway 2023 年第二季電話會議。 （操作員說明）謹此提醒，此通話正在錄音。現在我想介紹今天會議的主持人史蒂芬舒茲。你可以開始了。

Welcome all of you, and thank you for joining us today for our second quarter 2023 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; Mike Falvey, our Chief Financial Officer; and Dr. Guy Goodwin, our Chief Medical Officer. This 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 年第二季業績電話會議。我的名字是 Steve Schultz，COMPASS Pathways 投資人關係資深副總裁。今天，我們的執行長 Kabir Nath 也加入了我的行列。 Mike Falvey，我們的財務長；以及我們的首席醫療官 Guy Goodwin 博士。本次電話會議正在錄音中，並將在電話會議結束後不久發佈在 COMPASS Pathways 的投資者關係網站上。

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.

在我們開始之前，讓我提醒大家，在今天的電話會議中，團隊將根據 1995 年《私人證券訴訟改革法》修訂案的含義做出前瞻性陳述。您不應過度依賴這些前瞻性陳述。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」標題下所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 as of any subsequent date. We specifically disclaim any obligation to update or revise any forward statement, 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在任何後續日期的觀點。即使我們的估計或假設發生變化，我們特別不承擔更新或修改任何前瞻性聲明的義務。

I'll now hand the call over to Kabir Nath.

我現在將把電話轉給卡比爾·納斯。

Thank you, Steve. Good day, everyone, and thank you for joining us. During this past quarter, COMPASS Pathways has continued to achieve strong results across important aspects of our business. I will cover the progress of our trials as well as commercial updates.

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 在我們業務的重要方面繼續取得了強勁的業績。我將介紹我們的試驗進度以及商業更新。

Guy will talk about encouraging regulatory and clinical news, and Mike will address the excellent progress we have made to extend our financial runway. Our Phase III trials in treatment-resistant depression, COMP 005 and COMP 006 are ongoing and remain on track for primary endpoint readouts in summer 2024 and mid-2025, respectively. Both studies are on track and in line with our expectations, with some patients having now progressed to Part B for both studies. 2/3 of the Comp 005 sites have been initiated.

蓋伊將談論令人鼓舞的監管和臨床新聞，麥克將討論我們在擴展財務跑道方面取得的出色進展。我們針對難治性憂鬱症的 III 期試驗 COMP 005 和 COMP 006 正在進行中，並有望分別於 2024 年夏季和 2025 年中期公佈主要終點數據。這兩項研究均按計劃進行，符合我們的預期，部分患者現已進入兩項研究的 B 部分。 Comp 005 站點的 2/3 已啟動。

I'll remind you that these are the largest, most robust trials ever conducted to evaluate the use of psilocybin treatment or indeed any psychedelic drug, and the trials are designed to support an NDA submission to the FDA. We noted in the first quarter that the American Medical Association has accepted a current procedural terminology, or CPT III code for psychedelic therapies.

我要提醒您的是，這些是有史以來規模最大、最有力的試驗，旨在評估裸蓋菇素治療或任何致幻藥物的使用情況，這些試驗旨在支持向 FDA 提交新藥申請 (NDA)。我們在第一季注意到，美國醫學會已接受目前的程序術語，即迷幻療法的 CPT III 代碼。

In the second quarter, as it happened on the last day of the quarter, the actual code language was released. As we have indicated, this language specifically provides physicians and other qualified health care professionals with a means to track the work involved in and ultimately seek reimbursement for delivering support for psychedelic treatments.

在第二季度，正如該季度的最後一天一樣，實際的程式碼語言發布了。正如我們所指出的，這種語言專門為醫生和其他合格的醫療保健專業人員提供了一種方法來追蹤所涉及的工作並最終尋求為迷幻治療提供支援的報銷。

We hosted a webinar on this development, which include experts from both the payer and treatment delivery communities. I hope you had a chance to watch the program, which is archived on our website in the Investors Section.

我們舉辦了關於這項發展的網路研討會，其中包括來自付款人和治療提供社區的專家。我希望您有機會觀看該節目，該節目已存檔在我們網站的投資者部分。

We believe the language of the CPT III tracking code is particularly well aligned with the requirements of COMP360 psilocybin treatment and a crucial step toward a reimbursed CPT code that covers psychological support for therapies like COMP360, subject to FDA approval. Most importantly, it's a key step towards enabling broad and equitable access to psychedelic treatments. Without CPT codes, it will be challenging to obtain reimbursement by CMS and health plans in the U.S. for the psychological support provided during the administration of COMP360, which would result in a severe limitation of access to new and effective treatments that require in-person support.

我們相信 CPT III 追蹤代碼的語言特別符合 COMP360 裸蓋菇素治療的要求，也是邁向報銷 CPT 代碼的關鍵一步，該代碼涵蓋 COMP360 等療法的心理支持，但須經 FDA 批准。最重要的是，這是實現廣泛和公平獲得迷幻治療的關鍵一步。如果沒有 CPT 代碼，美國的 CMS 和健康計劃將很難獲得在 COMP360 給藥期間提供的心理支持的報銷，這將導致獲得需要親自支持的新的有效治療的嚴重限制。

This CPT III code is an important recent development that supports the commercial landscape into which we plan to launch COMP360. We also saw this quarter that esketamine sold under the brand name Spravato, has now achieved sales of $255 million for the first half of the year in the U.S. with quarter-over-quarter growth of roughly 30% and year-over-year growth of over 80%.

此 CPT III 代碼是最近的一項重要開發，支持我們計劃推出 COMP360 的商業環境。本季我們也看到，艾氯胺酮以 Spravato 品牌銷售，目前在美國上半年的銷售額為 2.55 億美元，環比成長約 30%，年成長超過80%。

We believe that this demonstrates the level of unmet need in treatment-resistant depression. This growth is also driven by the increasing interest in mechanisms, which offer rapid treatment effect as well as the scaling of the infrastructure of interventional psychiatry facilities and other treatment centers.

我們相信，這顯示難治性憂鬱症的需求未被滿足的程度。這種增長也是由於人們對提供快速治療效果的機制越來越感興趣，以及介入精神病學設施和其他治療中心基礎設施的規模擴大而推動的。

These are the types of facilities that we believe would be able to deliver COMP360 treatment, if approved. Also in this quarter, the U.S. Patent Trial and Appeal Board reaffirm decisions to uphold 2 key patents, the 257 and 259 patents, which cover the COMP360 crystalline psilocybin polymorph A. Intellectual property is a key element of our overall commercial protection for COMP360 and central to our work in developing innovative treatments for therapeutic areas of significant unmet medical need. We were pleased with this decision as it marks the conclusion of what had been outstanding challenges to these patents.

我們相信，如果獲得批准，這些類型的設施將能夠提供 COMP360 治療。同樣在本季度，美國專利審判和上訴委員會重申維持2 項關鍵專利（257 號和259 號專利）的決定，這些專利涵蓋COMP360 結晶裸蓋菇素多晶型物A。智慧財產權是我們對COMP360 和核心產品整體商業保護的關鍵要素。感謝我們為未滿足重大醫療需求的治療領域開發創新療法的工作。我們對這項決定感到高興，因為它標誌著這些專利面臨的突出挑戰的結束。

I'll now hand over to Guy to update you on regulatory and clinical news during the quarter. Guy?

現在我將請蓋伊向您介紹本季監管和臨床新聞的最新情況。蓋伊？

Thank you, Kabir. In the past quarter, the FDA issued draft guidance on the development of psychedelic medicines to address the unique features of this class of treatment. We are pleased that this guidance is well aligned with the COMP360 Phase III program design and includes many of the points that we have discussed with the agency. We believe this guidance is an important validation that FDA is supportive of a robust and appropriate development path for novel psychedelic-based treatment like COMP360. A particular note in the FDA guidance is the use of psychotherapy where the agency cautions such interventions may complicate the assessment of clinical trials.

謝謝你，卡比爾。上個季度，FDA 發布了迷幻藥物開髮指南草案，以解決此類治療的獨特特徵。我們很高興該指南與 COMP360 第三階段計劃設計非常一致，並且包含我們與該機構討論過的許多要點。我們認為，該指南是 FDA 支持 COMP360 等新型致幻劑治療藥物穩健且適當的開發路徑的重要驗證。 FDA 指南中特別指出的是心理治療的使用，該機構警告稱，此類幹預措施可能會使臨床試驗的評估變得複雜。

I will note that COMP360 treatment is not designed to utilize psychotherapy but instead, psychological support, which primarily focuses on safeguarding patients. In fact, we think it is inappropriate to refer to psilocybin treatment as psychedelic-assisted psychotherapy as commonly occurs.

我要指出的是，COMP360 治療的目的不是利用心理治療，而是利用心理支持，主要著重於保護病人。事實上，我們認為將裸蓋菇素治療稱為迷幻輔助心理治療是不合適的。

Regulators generally evaluate and approve investigational drug candidates based on quality, safety and efficacy. They have not historically evaluated or regulated psychotherapy. Our approach is clear to achieve regulatory approval, the drug effect needs to be established unambiguously in clinical trials, which is only possible with any psychological support is applied in a consistent way and is not an alternative treatment itself.

監管機構通常根據品質、安全性和有效性來評估和批准研究候選藥物。他們歷史上沒有評估或規範心理治療。我們的方法很明確，要獲得監管部門的批准，藥物效果需要在臨床試驗中明確確定，這只有在以一致的方式應用任何心理支持的情況下才有可能實現，而不是替代治療本身。

A recent opinion piece we published with academic colleagues in the American Journal of Psychiatry goes into more detail about the important distinction. The evidence we have seen from rigorous studies of psilocybin treatment to date leaves us to believe that the potential therapeutic effect of psilocybin treatment comes primarily from the drug itself, while psychological support is essential for safeguarding patients before, during and after administration.

我們最近與學術同事在《美國精神病學雜誌》上發表的一篇評論文章更詳細地介紹了這個重要差異。到目前為止，我們從裸蓋菇素治療的嚴格研究中看到的證據讓我們相信，裸蓋菇素治療的潛在治療效果主要來自藥物本身，而心理支持對於在給藥前、給藥期間和給藥後保護患者至關重要。

Psychological support is not independent psychotherapy as commonly understood. The intense psychedelic states associated with psilocybin are incompatible with simultaneous evidence-based psychotherapy.

心理支持並不是一種通常理解的獨立心理治療。與裸蓋菇素相關的強烈迷幻狀態與同步實證心理治療不相容。

Turning to our clinical studies. In July, the Journal of Neuropsychopharmacology published our data from an open-label study that suggested that the use of selective serotonin reuptake inhibitors or SSRI antidepressant does not interfere with the potential therapeutic effect of COMP360. As we have remarked previously, this finding, if confirmed, may prove to have important implications for the eventual real-world use of COMP360, because it could offer patients potentially greater choice in how far they withdraw from other drugs before treatment with COMP360 in the future.

轉向我們的臨床研究。 7 月，《神經精神藥理學雜誌》發表了我們的一項開放標籤研究數據，該研究表明使用選擇性血清素再攝取抑制劑或 SSRI 抗憂鬱藥物不會幹擾 COMP360 的潛在治療效果。正如我們之前所說，這項發現如果得到證實，可能會對COMP360 的最終實際使用產生重要影響，因為它可以為患者提供潛在的更多選擇，讓他們在使用COMP360 治療之前從其他藥物中退出多遠。未來。

Beyond treatment-resistant depression, our Phase II studies in PTSD and anorexia nervosa continue to progress well with PTSD data expected this year. It is still too early to provide a readout guidance for the anorexia nervosa study, which is now making much better progress after amendment to our protocol. We will update you regarding timing on future calls.

除了難治性憂鬱症之外，我們在 PTSD 和神經性厭食症方面的 II 期研究繼續取得良好進展，預計今年將獲得 PTSD 數據。現在為神經性厭食症研究提供讀數指導還為時過早，該研究在修改我們的方案後目前取得了更好的進展。我們將向您通報未來通話的時間安排。

Looking beyond our sponsored trial to investigator-initiated study, we continue to see encouraging data emerge. For example, a study of cancer patients with depression who received a single dose of COMP360 psilocybin treatment was presented at this year's ASCO meeting, and a study demonstrating the potential for COMP360 psilocybin treatment in female patients with anorexia nervosa was published in Nature Medicine.

除了我們贊助的試驗和研究者發起的研究之外，我們繼續看到令人鼓舞的數據出現。例如，今年的ASCO 會議上提出了一項針對接受單劑量COMP360 裸蓋菇素治療的癌症抑鬱症患者的研究，而一項證明COMP360 裸蓋菇素治療女性神經性厭食症患者潛力的研究發表在《Nature Medicine》上。

These data support the robust knowledge base that COMPASS is developing around our COMP360 treatment. Moreover, this preliminary research can be an important step in finding new and better options for patients with difficult-to-treat conditions. I will now hand the call to Mike for the financial overview. Mike?

這些數據支持 COMPASS 圍繞 COMP360 治療開發的強大知識庫。此外，這項初步研究可能是為患有難治性疾病的患者尋找新的更好選擇的重要一步。我現在將把電話轉給麥克，了解財務概況。麥克風？

Thank you, Guy. I'll now recap the highlights of our second quarter financial results. Comparing this year to last year, for the second quarter 2023, net loss was $28.3 million or $0.62 per share, including noncash share-based compensation of $4.6 million compared to net loss of $21 million or $0.50 per share, including noncash share-based compensation of $3.2 million for second quarter 2022.

謝謝你，蓋伊。現在我將回顧我們第二季財務業績的亮點。與去年相比，2023 年第二季的淨虧損為2,830 萬美元，即每股0.62 美元，包括460 萬美元的非現金股份補償，而淨虧損為2,100 萬美元，即每股0.50 美元，包括非現金股份補償2022 年第二季的收入為 320 萬美元。

The R&D expenses increased to $19.8 million in second quarter 2023 compared with $15.9 million in the second quarter of last year. G&A expenses increased to $12.8 million in second quarter 2023 compared to $11.3 million in second quarter 2022.

2023 年第二季研發費用增至 1,980 萬美元，去年第二季為 1,590 萬美元。 2023 年第二季的一般管理費用增至 1,280 萬美元，而 2022 年第二季為 1,130 萬美元。

I'll now turn to analysis of our current second quarter results compared to the prior first quarter results. Our current quarter financial results reflect our continued success in advancing our Phase III trial in treatment-resistant depression and encouraging progress in expanding our cash runway. In line with our expectations, cash used in operations in the second quarter was $24.8 million in the middle of the guidance range we provided last quarter.

我現在將分析我們目前第二季的業績與之前第一季的業績相比。我們目前季度的財務表現反映了我們在推動難治性憂鬱症三期試驗方面的持續成功，以及在擴大現金跑道方面取得的令人鼓舞的進展。與我們的預期一致，第二季度營運中使用的現金為 2,480 萬美元，處於我們上季度提供的指導範圍的中間位置。

In this quarter, net loss was $28.3 million or $0.62 per share compared with a net loss of $24.2 million or $0.57 per share for the prior quarter. These results include noncash share-based compensation of $4.6 million and $4.1 million in the prior quarter. R&D expenses were $19.8 million in this quarter compared with $19 million in the prior quarter. The increase was mainly due to external development expenses related to our Phase III program. Other expenses also increased. G&A expenses were consistent in both quarters at $12.8 million.

本季淨虧損為 2,830 萬美元，即每股 0.62 美元，而上一季淨虧損為 2,420 萬美元，即每股 0.57 美元。這些業績包括 460 萬美元的非現金股票薪酬和上一季的 410 萬美元。本季的研發費用為 1,980 萬美元，而上一季的研發費用為 1,900 萬美元。增加的主要原因是與我們的第三期專案相關的外部開發費用。其他費用也有所增加。兩個季度的一般管理費用均維持在 1,280 萬美元。

Turning to our balance sheet. Cash increased by $31.1 million in the second quarter of 2023 and as financing activities generated $55.9 million. At the end of June, we concluded a potential $50 million debt facility with Hercules Capital and drew down $28.8 million net of issuance costs. Earlier in the quarter, we raised an additional $26.9 million from the sale of shares under our ATM facility. This financing activity was offset by net cash used in operating activities of $24.8 million. Regarding third quarter financial guidance, we expect 2 factors to create an unusually low range for cash used in operations, which we expect will return to a more conventional level in the fourth quarter and beyond.

轉向我們的資產負債表。 2023 年第二季現金增加 3,110 萬美元，融資活動產生 5,590 萬美元。 6 月底，我們與 Hercules Capital 達成了一項潛在的 5,000 萬美元債務融資協議，扣除發行成本後提取了 2,880 萬美元。本季早些時候，我們透過 ATM 設施出售股票額外籌集了 2,690 萬美元。這項融資活動被經營活動所用現金淨額 2,480 萬美元所抵銷。關於第三季的財務指引，我們預計有兩個因素將導致營運中使用的現金處於異常低的範圍，我們預計將在第四季度及以後恢復到更傳統的水平。

We expect the third quarter net cash used in operating activities to be between minus $2 million and positive $18 million. First, we have completed contracts with our vendors, reflecting the final Phase III trial design. As a result, we will be able to reduce the balance of our prepaid cost, which will reduce our cash used in operations in the third quarter by close to $10 million. Second, we are expecting to receive our estimated $14 million 2022 UK, R&D tax credit in the third quarter. The low end of our guidance reflects the receipt of these funds in Q3, and the top end of the guidance reflects the funds being delayed until Q4.

我們預計第三季經營活動使用的淨現金將在負 200 萬美元至正 1,800 萬美元之間。首先，我們已經與供應商完成了合同，反映了最終的第三階段試驗設計。因此，我們將能夠減少預付費用餘額，這將使我們第三季營運中使用的現金減少近 1,000 萬美元。其次，我們預計在第三季獲得預計 2022 年英國 1,400 萬美元的研發稅收抵免。我們指導的下限反映了第三季收到的這些資金，指導的上限反映了資金被推遲到第四季度。

Turning to full year financial guidance. We are narrowing the range for cash used in operations to be between $80 million and $90 million. We have narrowed our full year range as a result of improved clarity around the scale and timing of expected Phase III costs and continued spending discipline in light of continued market uncertainty.

轉向全年財務指引。我們正在將營運中使用的現金範圍縮小到 8,000 萬美元至 9,000 萬美元之間。由於預期第三階段成本的規模和時間安排更加明確，考慮到市場持續的不確定性，我們繼續嚴格支出，因此我們縮小了全年範圍。

COMPASS continues to maintain a strong financial position with cash and cash equivalents of $148.2 million at June 30, 2023, compared with $143.2 million at December 31, 2022. We have recognized long-term debt on our balance sheet for the first time as a result of the debt facility to Hercules Capital, which we initiated in the second quarter. We continue to view our strong balance sheet as an important strategic asset, which we plan to manage carefully as we invest to advance these promising potential treatment while at the same time continuing to create value for our shareholders. Thank you, and I'll now turn the call back to Kabir.

COMPASS 繼續保持強勁的財務狀況，截至 2023 年 6 月 30 日，現金和現金等價物為 1.482 億美元，而 2022 年 12 月 31 日為 1.432 億美元。因此，我們首次在資產負債表上確認了長期債務我們在第二季啟動了向Hercules Capital 提供的債務融資。我們繼續將強大的資產負債表視為重要的策略資產，我們計劃在投資時謹慎管理資產，以推進這些有希望的潛在治療，同時繼續為股東創造價值。謝謝，我現在將電話轉回給卡比爾。

Thanks, Mike. We're pleased with our ongoing progress and continue to be conscious of the importance and responsibility of our leadership in the development of investigational psychedelic treatments, which we believe represents the next generation of mental health therapeutic options.

謝謝，麥克。我們對我們不斷取得的進展感到高興，並繼續意識到我們在研究性迷幻治療開發中的領導地位的重要性和責任，我們相信這代表了下一代心理健康治療選擇。

Importantly, our Phase III program in treatment-resistant depression is our clear focus and is progressing on track and in line with our expectations. As we moved through the clinical program and as we observe the commercial rollout of Spravato, we're encouraged by an increasingly supportive alignment in the treatment network infrastructure that's developed significantly since the Spravato launch.

重要的是，我們針對難治性憂鬱症的 III 期計畫是我們明確的重點，並且進展順利，符合我們的預期。當我們完成臨床計劃並觀察 Spravato 的商業推廣時，我們對自 Spravato 推出以來顯著發展的治療網絡基礎設施中日益支持的協調感到鼓舞。

We believe that this reflects a treatment paradigm that is here to stay, and we would expect much of this infrastructure relevant to COMP360 as well. In closing, I want to offer a heartfelt thank you to one of our co-founders, Dr. Ekaterina Malievskaia, who recently stepped down from her executive role as Chief Innovation Officer. Together with George Goldsmith and Lars Wilde, Katya co-founded COMPASS Pathways in 2017, determined to bring much needed innovation to the field of mental health care.

我們相信，這反映了一種將繼續存在的治療範式，我們預計該基礎設施的大部分也與 COMP360 相關。最後，我要向我們的共同創辦人之一 Ekaterina Malievskaia 博士表示衷心的感謝，她最近辭去了首席創新長的職務。 Katya 於 2017 年與 George Goldsmith 和 Lars Wilde 共同創立了 COMPASS Pathways，決心為精神健康保健領域帶來急需的創新。

Katya leaves an indelible mark on the company she helped found. COMPASS today reflects both the rigor and precision one would expect from a scientist and the compassion for and commitment to patients that one would expect from a physician. That influence extends well beyond our company to the field of psychedelic medicine and mental health care. We're closer to for breakthroughs in care for patients, thanks to her work.

卡蒂亞在她幫助創建的公司上留下了不可磨滅的印記。現今的 COMPASS 既體現了人們對科學家的嚴謹和精確的期望，也體現了人們對醫生的期望對病人的同情和承諾。這種影響力遠遠超出了我們公司的範圍，並延伸到迷幻醫學和心理保健領域。感謝她的工作，我們在患者護理方面更接近突破。

We're pleased that we'll continue to benefit from her experience and insights as she remains on the COMPASS Board of Directors. And I know that I speak on behalf of the entire COMPASS team in thanking her for her extraordinary vision, leadership and encouragement.

我們很高興她繼續留在 COMPASS 董事會，我們將繼續受益於她的經驗和見解。我知道我代表整個 COMPASS 團隊感謝她非凡的遠見、領導力和鼓勵。

Thank you once again for your participation in today's call. We'll now turn to Q&A. So I will hand this call 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。所以我會把這通電話轉交給接線生。

(Operator Instructions) Our first question comes from Ritu Baral with TD Cowen.

（操作員說明）我們的第一個問題來自 Ritu Baral 和 TD Cowen。

This is Athena on for Ritu. To start off, I know in the 8-K, you issued today that ATAI has requested that COMPASS registered their shares. Could you provide any color on that request? And I have a follow-up question after this one.

這是雅典娜為 Ritu 配音的節目。首先，我知道在 8-K 中，您今天發布的 ATAI 已要求 COMPASS 註冊其股票。您能根據該要求提供任何顏色嗎？在這個問題之後我還有一個後續問題。

Thanks, Athena. It's -- just checking, you can hear me clearly.

謝謝，雅典娜。只要檢查一下，你能清楚地聽到我說話。

Yes.

是的。

So our understanding is that ATAI -- this is a matter of regular corporate housekeeping.

所以我們的理解是 ATAI——這是一個常規的企業內務管理問題。

Got it. And my next goes back to the CPT code. Is there a level 1 code that exists as a maybe a good comparison for how you see the new CPT codes maturing into? We understand from KOLs that they often use some existing codes to cover ketamine administration. What are those? And what do they reimburse that?

知道了。接下來我回到 CPT 代碼。是否存在 1 級代碼，可以作為您如何看待新 CPT 代碼成熟的一個很好的比較？我們從KOL那裡了解到，他們經常使用一些現有的代碼來涵蓋氯胺酮的管理。那些是什麼？他們補償什麼？

Thank you for the question. So yes, certainly, if we look at the history of ketamine prescribing or indeed esketamine, once Janssen launched Spravato because no specific codes were applied for or approved for those, it is absolutely the case that providers have had to make 2 with existing codes. And I can't give you the specific details of which codes they use, but we're happy to follow up with that in more detail in the future. I think what's important to note is that us, we recognize that what we are doing is unique. The 6- to 8-hour support required for psilocybin, demanded that we actually do seek approval for as we now have received a new code.

感謝你的提問。所以，是的，當然，如果我們回顧氯胺酮處方或艾氯胺酮的歷史，一旦楊森推出了 Spravato，因為沒有申請或批准這些藥物的具體代碼，供應商絕對必須使用現有代碼來生產 2 種藥物。我無法向您提供他們使用哪些程式碼的具體細節，但我們很樂意在將來更詳細地跟進。我認為值得注意的是，我們認識到我們正在做的事情是獨一無二的。裸蓋菇素所需的 6 至 8 小時支援要求我們確實尋求批准，因為我們現在已經收到了新代碼。

And as you'll be aware, this CPT III code provides for on an hourly basis, the tracking of the support that's required for psychedelic measures. And therefore, we're confident that this code will apply very much to us for the future but also potentially for other products that would require similar extended support, such as MDMA, if that would be approved for MDMA-assisted therapy.

如您所知，此 CPT III 代碼按小時提供迷幻措施所需支援的追蹤。因此，我們相信該準則未來將非常適用於我們，也可能適用於其他需要類似擴展支援的產品，例如 MDMA，如果它被批准用於 MDMA 輔助治療的話。

Important to note, though, that the preparation and integration sessions that are also required for COMP360 psilocybin treatment will also be come by existing codes. They will be covered by existing psychotherapy codes.

但值得注意的是，COMP360 裸蓋菇素治療所需的準備和整合過程也將由現有代碼提供。他們將受到現有心理治療規範的保護。

Our next question comes from Charles Duncan with Cantor.

我們的下一個問題來自查爾斯鄧肯和康托。

Thanks for taking our question early, and congrats on the progress in the quarter, Kabir and team. I basically had 3 quick questions on the ongoing COMP 005 and 006 trials. I'll just rattle them off quickly, and you can take them in order, if you want. The first is, are you seeing any, call it, rate limiter in terms of SSRI use and weaning off that in terms of enrollment in those trials.

感謝您儘早提出我們的問題，並祝賀卡比爾和團隊在本季度取得的進展。關於正在進行的 COMP 005 和 006 試驗，我基本上有 3 個簡短的問題。我會很快地把它們講出來，如果你願意的話，你可以按順序聽。第一個是，您是否看到任何 SSRI 使用方面的速率限制器，以及在這些試驗的註冊方面逐漸減少的速率限制器。

The second is for Part B progression, are you seeing any differences in the option for retreatment thus far? I know it's probably early, you probably don't have a lot of patients, but differences between the 2 trials.

第二個是 B 部分的進展，到目前為止，您是否發現再治療的選擇有任何差異？我知道這可能還為時過早，可能沒有很多患者，但兩項試驗之間存在差異。

And third question quickly is for Part C, you probably aren't quite there yet, but have you had any patients enrolled in Part C? Or are you near to enrolling patients in Part C having gotten through week 26 of Part B?

第三個問題是關於 C 部分的，您可能還沒有完全做到這一點，但是您是否有任何患者參加了 C 部分？或者您是否即將在 B 部分第 26 週之後將患者納入 C 部分？

Thanks, Charles. So I'll start and if Guy has any color to add, I'll ask him to jump in. So no, I mean, it's been very clear in our protocol, both in IIb and Phase III that washout is required. These are monotherapy trials. So far, we're not seeing any experience that's very different from what we saw in IIb. Obviously, for some patients, this is a significant issue, and we saw that in Part IIb, and we will see it in Part III as part of the prescreening and the screen, but it remains the fact that these are monotherapy trials and again, so far, the experience is consistent from our last trial to this one.

謝謝，查爾斯。所以我會開始，如果蓋伊有任何顏色要添加，我會請他加入。所以不，我的意思是，我們的協議中非常清楚，無論是在 IIb 階段還是在 III 階段，都需要進行清洗。這些是單一療法試驗。到目前為止，我們還沒有看到任何與 IIb 中看到的體驗有很大不同的體驗。顯然，對於某些患者來說，這是一個重要的問題，我們在第二部分b中看到了這一點，我們將在第三部分中看到它作為預篩選和篩檢的一部分，但事實仍然是這些是單一療法試驗，而且，到目前為止，從我們上次的試驗到這次的體驗都是一致的。

In terms of Part B and Part C, the numbers are not where I'm in a position to give you an answer on those at this stage. I would just go back to what I said, we're on track, in line with our expectations with group. Guy, anything to add on?

就 B 部分和 C 部分而言，現階段我無法就這些數字給出答案。我只想回到我所說的，我們正在步入正軌，符合我們對團隊的期望。哥們，還有什麼要補充的嗎？

I don't think so...

我不這麼認為...

Our next question comes from Patrick Trucchio with H.C. Wainwright.

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

Congrats on all the progress. So several studies have been published recently as noted in today's press release, I'm wondering if you could talk about the level of interest or acceptance in psilocybin therapy, specifically among neuropsych key opinion leaders and clinical trial investigators and how these views have changed, if at all? And how do you view this evolution of use progressing as we get closer to that Phase III readout next year?

祝賀所有的進展。正如今天的新聞稿所述，最近發表了幾項研究，我想知道您是否可以談談對裸蓋菇素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之間的興趣或接受程度，以及這些觀點是如何改變的，如果有的話？隨著明年我們越來越接近第三階段的結果，您如何看待這種使用進度的演進？

Thanks, Patrick. I will pass that to Guy.

謝謝，派崔克。我會將其傳遞給蓋伊。

Thanks, Patrick. I think there's been a consolidation rather than a change. I think people are a bit clearer now about what's actually required. We've worked pretty hard to emphasize our innovation and our forward-looking in this field and to also emphasize that our reliance is on data. And I think that's respected. And I think that's one of the ways we get progress. And of course, that speed is what we really want in terms of getting this to patients as soon as possible. I mean clearly, there's no immediate possibility that the clinicians of the kind you describing can use the treatment. So it remains for most of them a little hypothetical, but the interest is still there.

謝謝，派崔克。我認為這是一種整合而不是變化。我認為人們現在對實際需要什麼更加清楚了。我們非常努力地強調我們在這一領域的創新和前瞻性，並強調我們對數據的依賴。我認為這是受到尊重的。我認為這是我們取得進步的方式之一。當然，為了盡快提供給患者，這種速度是我們真正想要的。我的意思很明確，您所描述的那種臨床醫生不可能立即使用這種治療方法。因此，對於大多數人來說，這仍然有點假設，但興趣仍然存在。

And I think as we move forward with this greater evidence around the prevalence of TRD, the unmet need that is clearly there. I think that's been an important change really just in the last year or 2 with really quite influential reviews that have highlighted that change. And I think that underlines more than anything, the increased use of Spravato.

我認為，隨著我們圍繞 TRD 的流行提供更多證據，顯然存在未滿足的需求。我認為這是最近一兩年發生的一個重要變化，非常有影響力的評論強調了這一變化。我認為這最重要的是強調了 Spravo 使用的增加。

Can you talk a little bit more about the PTAB decision and the commentary around outstanding challenges to COMP360 patents? Specifically, I'd like to know how we should think about the durability of COMP360 IP, particularly against future potential challenges following the PTAB decision.

您能否多談談 PTAB 的決定以及對 COMP360 專利面臨的突出挑戰的評論？具體來說，我想知道我們應該如何考慮 COMP360 IP 的耐用性，特別是針對 PTAB 決定後未來潛在的挑戰。

Yes. So Patrick, I mean, to be clear, what the PTAB decision does is it's uphold the validity of our patent and it exhausts all the remaining lines of challenge or review against these patents. From our perspective, that clearly does increase our confidence that these are robust patents that we will be able to defend in the future in our commercial world, but we've always believed that these are robust patents that give us significant protection based on the extensive work we did to arrive (inaudible).

是的。所以派崔克，我的意思是，要明確的是，PTAB 的決定的作用是維護我們專利的有效性，並窮盡針對這些專利的所有剩餘質疑或審查途徑。從我們的角度來看，這顯然增強了我們的信心，相信這些都是強大的專利，我們將能夠在未來的商業世界中捍衛這些專利，但我們始終相信，這些強大的專利基於廣泛的專利為我們提供了重要的保護。我們為到達所做的工作（聽不清楚）。

Our next question comes from Francois Brisebois with Oppenheimer.

我們的下一個問題來自弗朗索瓦·布里斯布瓦和奧本海默。

Just to start here. I was just wondering, can you talk about your comfort with these trials kind of being the last potential trials in order to submit just based around the fact that -- you do have a washout period and the SSRS situation. Is this something that's evolving? Or are people comfortable with the monotherapy in the washout?

只是從這裡開始。我只是想知道，你能否談談你對這些試驗的舒適度，這些試驗是最後一次潛在的試驗，以便基於這樣的事實提交——你確實有一個沖洗期和 SSRS 情況。這是正在發展的嗎？或者人們對沖洗中的單一療法感到滿意嗎？

So I'll start. One thing to know, and we did note, I mean it's a small study, but we did actually publish during this quarter a paper of 19 patients on psilocybin on a background of SSRIs, and we saw no diminution of effect. So it adds an important piece of data, as Guy noted, which needs to be confirmed on a larger scale. .

那我就開始吧。有一點需要知道，我們確實注意到，我的意思是這是一項小型研究，但我們實際上在本季度發表了一篇論文，涉及19 名患者在SSRI 背景下服用裸蓋菇素，並且我們沒有看到效果減弱。因此，正如蓋伊所指出的那樣，它添加了一個重要的數據，需要在更大範圍內進行確認。 。

I think it's clear from the point of view of really demonstrating the efficacy and safety of COMP360, but monotherapy is the right way to study it. What we've also commented in the past, though, is as you look at the design of Part B and Part C, there will be data in patients who have gone back on antidepressant who subsequently take COMP360, and to your question, we recognize that, that may reflect some of what happens in the real world. Guy?

我認為從真正證明COMP360的有效性和安全性的角度來看是很清楚的，但單一療法是研究它的正確方法。不過，我們過去也曾評論過，當您查看 B 部分和 C 部分的設計時，將會有重新服用抗憂鬱藥物並隨後服用 COMP360 的患者的數據，對於您的問題，我們認識到這可能反映了現實世界中發生的一些事情。蓋伊？

Yes. I think just on the point of view, the question also related earlier to the difficulties that it poses having to withdraw people. It is worth remembering that the Phase II study had exactly the same approach, and that was successful and particularly in the latter part of that study, really had an accelerating recruitment rate. So I think we remain comfortable that's the right way to go in view of the theoretical need to demonstrate efficacy without a background of other drugs.

是的。我認為僅從角度來看，這個問題之前也與撤回人員所帶來的困難有關。值得記住的是，第二階段研究採用了完全相同的方法，並且是成功的，特別是在研究的後半部分，招募率確實在加快。因此，我認為，鑑於理論上需要在沒有其他藥物背景的情況下證明療效，我們仍然認為這是正確的方法。

Do you -- on that note, do you see a difference here in terms of the monotherapy approach for TRD versus MDD when by definition, patients with TRD have failed multiple approaches? Or is this TRD and MDD are probably going to be taken in a similar context here?

就此而言，您是否認為 TRD 與 MDD 的單一治療方法有差異，而根據定義，TRD 患者的多種治療方法都失敗了？或者 TRD 和 MDD 可能會在類似的背景下被採用？

That's a good question for which I don't think we yet have an answer. The answer will really be based on our future experience, particularly in the second and third phases of our trials and in the 006 where there will be 2 treatments mean the issue of whether there will be a need for continuing treatment, I think, at the moment is open. The differences between MDD and TRD essentially reflect the fact that MDD is an easier condition to treat. There is no unmet need and that there are treatments already available. The difference obviously with TRD is it's harder to treat and people have exhausted often the obvious treatments for MDD.

這是一個很好的問題，但我認為我們還沒有答案。答案實際上將基於我們未來的經驗，特別是在我們試驗的第二階段和第三階段，以及在 006 中，將有 2 種治療，這意味著是否需要繼續治療的問題，我認為，時刻是開放的。 MDD 和 TRD 之間的差異本質上反映了一個事實：MDD 是一種更容易治療的疾病。沒有未滿足的需求，並且已經有可用的治療方法。 TRD 的明顯區別在於它更難治療，而且人們通常已經用盡了 MDD 的明顯治療方法。

Okay. Great. And just maybe for those less familiar here, can you just touch on the -- we talked about Spravato and esketamine kind of take off here and how things are going in the correlation with you guys. Can you just maybe help us understand the compare and contrast, especially the differences here with your approach versus Spravato.

好的。偉大的。也許對於那些不太熟悉這裡的人來說，您能談談我們討論過的 Spravato 和 esketamine 在這裡的起飛以及事情進展如何與您相關。您能否幫助我們理解比較和對比，特別是您的方法與 Spravo 的差異。

So clearly, for esketamine, it is a somewhat associated drug and the requirement is for a monitoring period after the self-administration of the drug. Clearly, with psilocybin, what we require is psychological support during the administration of the drug, which is a 6- to 8-hour session. However, the similarities and the reason we refer to this as demonstrating the growth of the infrastructure that's getting to the infrastructure and it does require for esketamine, a dedicated space. It does require the place for the patient to be, it requires some time up of provider resources. And not only that, I think from a provider or an infrastructure perspective, but also a very important point that the acceptance of a rapidly acting novel mechanism in this space is also very important to us. So I think that's where we would leave it for now.

顯然，對於艾氯胺酮來說，它是一種某種程度上相關的藥物，並且要求在自我給藥後有一段監測期。顯然，對於裸蓋菇素，我們需要的是用藥期間的心理支持，用藥時間為 6 至 8 小時。然而，相似之處和我們將此稱為展示基礎設施的增長的原因是基礎設施正在進入基礎設施，並且它確實需要艾氯胺酮，一個專用空間。它確實需要患者所在的地方，也需要提供者資源的一些時間。不僅如此，我認為從供應商或基礎設施的角度來看，非常重要的一點是，在這個領域接受快速作用的新穎機制對我們來說也非常重要。所以我想這就是我們現在要保留的地方。

I think I would just add, of course, the number of visits required from the patient is really substantial in the case of ketamine or esketamine, whereas at the moment, we're looking at one, we're tapped trialing 1 or 2 visits for the treatment with COMP360.

當然，我想我只想補充一點，在氯胺酮或艾氯胺酮的情況下，患者所需的就診次數確實很大，而目前，我們正在考慮其中一種，我們正在嘗試 1 或 2 次就診用於COMP360治療。

Our next question comes from Elemer Piros with EFH.

我們的下一個問題來自 EFH 的 Elemer Piros。

Yes. Just wanted to confirm a couple of things about the PTSD study, Kabir. Is this a single dose that you administer to patients?

是的。卡比爾，我只是想確認創傷後壓力症候群研究的一些事情。這是您給患者服用的單次劑量嗎？

Yes, it is, Elemer.

是的，是的，埃萊默。

Yes. And is there a similar psychological support that is provided in preparation during the administration and maybe one follow-up session similarly to your TRD study.

是的。在治療期間是否會提供類似的心理支持，以及可能的後續療程，類似於您的 TRD 研究。

The design is very similar to the TRD study. we are obviously interested in the experience both of the patients and the therapist with this very different condition, but our psychological support is intended to be pretty generic and of course, as we've explained at some length, it is essentially about safety and safeguarding and it doesn't really deal with different psychopathologies.

設計與 TRD 研究非常相似。我們顯然對患者和治療師在這種截然不同的情況下的體驗感興趣，但我們的心理支持是非常通用的，當然，正如我們詳細解釋的那樣，它本質上是關於安全和保障它並沒有真正涉及不同的精神病理學。

Yes. So Guy, if I remember correctly, the FDA sort of lumped together in their draft guidance psychological support and psychotherapy or they may have used the term "and", do you think that there is an onus on you to demonstrate that there is no significant effect -- therapeutic effect, clinical benefit from the support component?

是的。所以蓋伊，如果我沒記錯的話，FDA 在他們的指導草案中將心理支持和心理治療混為一談，或者他們可能使用了“和”這個詞，你認為你有責任證明沒有顯著的影響嗎？效果－治療效果、臨床受益於支持成分嗎？

I think we're under -- I think we have an obligation to demonstrate the effects we observe are primarily attributed to the drug. I think we do that by using multiple dosage of regime, which was present in Phase II and we'll also be in 006. And we think that, that comparison between one dose and another is the key to efficacy. It is, of course, crucial that the psychological support is equivalent in the 2 cases, both before, during and after the administration of the drug. And we think that our procedures for monitoring that are going to ensure that we can demonstrate, that we are indeed delivering psychological support, which is consistent in all those phases of the treatment.

我認為我們有義務證明我們觀察到的效果主要歸因於該藥物。我認為我們透過使用多劑量的方案來做到這一點，該方案已出現在第二階段，我們也將在006 中進行。我們認為，一種劑量與另一種劑量之間的比較是療效的關鍵。當然，至關重要的是，這兩個病例在用藥前、用藥期間和用藥後的心理支持是相同的。我們認為，我們的監測程序將確保我們能夠證明，我們確實提供了心理支持，這在治療的所有這些階段都是一致的。

I think what the FDA has asked further for that is rather difficult and suggesting factorial designs and various variations in the therapist. We think that's difficult and will be of great interest if the academic sector wants to take that up and we will be interested in the results when they do.

我認為 FDA 進一步要求的內容相當困難，並建議治療師進行因子設計和各種變化。我們認為這很困難，如果學術界願意這樣做，我們將會非常感興趣，並且當他們這樣做時我們會對結果感興趣。

Yes. And I was just wondering how accurate perhaps clinicaltrials.gov is at the moment. I see 11 and 15 U.S. sites as markets are recruiting, probably there is some overlap between the 2 Phase III studies. Is this roughly accurate as a snapshot of the current situation?

是的。我只是想知道現在clinicaltrials.gov 的準確性如何。我看到 11 和 15 個美國站點正在招募市場，這兩個 III 期研究之間可能會有一些重疊。作為當前情況的快照，這是否大致準確？

Certainly, as we said, on 005, more than 2/3 of sites have now been initiated, and I'd remind you that 005 is a U.S.-only trial. 006 is clearly a global trial. We have U.S. sites up and running at the moment, yes.

當然，正如我們所說，關於005，現在已經有超過2/3的網站啟動了，我要提醒大家的是，005只是在美國進行試用。 006顯然是一場全球審判。是的，我們目前在美國有網站並且正在運行。

And what would be the rate limiting step to engage the European sites there?

參與歐洲網站的速率限制步驟是什麼？

We're getting approvals. And so that process is well underway. We do have approvals in some other countries already outside the states, but that process is well underway. And again, it's exactly in line with our expectation for the recruitment of 006.

我們正在獲得批准。這個過程正在順利進行中。我們確實已經在美國以外的其他一些國家獲得了批准，但這一過程正在順利進行中。再次強調，這也完全符合我們對006招募的預期。

Our next question comes from Tom Shrader with BTIG.

我們的下一個問題來自 BTIG 的 Tom Shrader。

I was going to follow on (inaudible) and PTSD. How large is this opportunity? Who are the patients? Are they mostly military and do a lot of them also have a diagnosis of depression? And what I'm kind of getting at is, do you see this as a separate indication? Or would this be a subset of patients where the approach -- depressed patients -- where the approach was particularly appropriate? And is the hope here to get into the VA system, where it might be an attractive option.

我打算繼續關注（聽不清楚）和創傷後壓力症候群（PTSD）。這個機會有多大？患者是誰？他們大多是軍人嗎？他們中的許多人也被診斷出患有憂鬱症嗎？我的意思是，你認為這是一個單獨的跡象嗎？或者這是該方法特別適合的患者子集——憂鬱症患者？希望進入 VA 系統，這可能是個有吸引力的選擇。

Yes. So if I can take that. I mean currently, it's not orientated specifically to the VA system. And that obviously is a great -- of interest to us in the future. At the moment, we're interested in the experience, the feasibility of doing these studies in this new indication. And we will know, obviously, after we completed this simple study, whether it is feasible. I think you can see it in 2 ways. In fact, it is a separate indication potentially but also it's an important comorbidity.

是的。所以如果我能接受的話。我的意思是，目前它並不是專門針對 VA 系統的。這顯然是我們未來非常感興趣的。目前，我們對在這個新適應症中進行這些研究的經驗和可行性感興趣。顯然，在我們完成這個簡單的研究之後，我們就會知道它是否可行。我認為你可以透過兩種方式來看待它。事實上，它可能是一個單獨的適應症，但也是一個重要的合併症。

We have an IIS, which will soon be reporting from California, which has recruited from the VA system, patients with treatment-resistant depression, we anticipate there will be a great deal of comorbidity with PTSD in that group. So to answer your question, we're interested in both conditions, both PTSD independently, which is what we're studying in London and New York and we're interested in TRD with comorbid PTSD which, of course, is highly relevant to the VA population.

我們有一個 IIS，很快就會從加州進行報告，該機構從 VA 系統招募了難治性憂鬱症患者，我們預計該組中會有大量 PTSD 合併症。因此，為了回答你的問題，我們對這兩種情況都感興趣，兩種都是獨立的PTSD，這就是我們在倫敦和紐約研究的內容，我們對伴隨共病PTSD 的TRD 感興趣，當然，這與維吉尼亞州人口。

Our next question comes from Kyle Qian with Canaccord Genuity.

我們的下一個問題來自 Canaccord Genuity 的 Kyle Qi。

This is Kyle speaking for Sumant Kulkarni, 2 from us. How close are you watching the potential for Biogen and Sage's zuranolone that might get approved later this week? We're asking because there could be some relevance to the use of psychedelic therapeutics in depression as an approval there could pave the way for more episodic treatments for the depression versus chronic treatment.

我是凱爾 (Kyle) 代表我們兩個人蘇曼特·庫爾卡尼 (Sumant Kulkarni) 發言。您對 Biogen 和 Sage 的 zuranolone 可能在本週晚些時候獲得批准的潛力有多關注？我們之所以這麼問，是因為迷幻療法在憂鬱症中的使用可能存在一定的相關性，因為迷幻療法的批准可能為憂鬱症的間歇性治療（而不是長期治療）鋪平道路。

Thanks, Kyle. So yes, I completely agree with you. If zuranolone, in fact, approved for MDD. And I know there's a lot of debate in the community around how likely that it is. Absolutely. I mean it is an interesting paradigm of a rapid acting with episodic retreatment on demand as it were on relapse, we would absolutely be observing that with interest to see what sort of acceptance that have, how stage -- end up positioning here. So yes, we are well aware of that.

謝謝，凱爾。所以是的，我完全同意你的觀點。事實上，如果 zuranolone 被批准用於 MDD。我知道社區中有很多關於這種可能性的爭論。絕對地。我的意思是，這是一個有趣的範例，即在復發時按需進行間歇性再治療的快速行動，我們絕對會饒有興趣地觀察，看看有什麼樣的接受度，處於什麼階段——最終在這裡定位。所以，是的，我們很清楚這一點。

Okay. Great. And then one more. Will the knowledge that COMP360 and that MDMA for PTSD have several differences in the respective programs. What are the types of results that COMP360 might need to achieve on the cap side for COMP360 to be competitive? And what would you need to see in your ongoing Phase II that might give you more confidence to proceed into Phase III?

好的。偉大的。然後還有一張。 COMP360 和 MDMA for PTSD 在各自的程式中是否有一些差異？ COMP360 可能需要在上限方面實現哪些類型的結果才能保持競爭力？在正在進行的第二階段中，您需要看到什麼，才能讓您更有信心進入第三階段？

Well, [Cap 5] is our end point or one of our endpoints in that study. So we'll have some idea of how to power any subsequent study. Clearly, the relative efficacy is best establishing a head-to-head comparison, and we're a long way from doing that, I suspect. So I think we will simply have to take it as it comes. We remain very interested in the indication, but it's a little premature to -- just trying to think, how we would compare with [MAPS]. So there's also quite an important difference in the demands for therapists time and indeed for the patient time between the 2 approaches, so is going to be a highly pragmatic comparison if and when it gets made.

嗯，[第 5 章] 是我們的終點或研究的終點之一。因此，我們將對如何為後續研究提供動力有一些想法。顯然，相對功效最好是建立面對面的比較，我懷疑我們距離做到這一點還有很長的路要走。所以我認為我們只能順其自然。我們仍然對該指示非常感興趣，但現在就想一下我們將如何與[MAPS]進行比較還為時過早。因此，兩種方法之間對治療師時間和患者時間的需求也存在相當重要的差異，因此如果進行比較，這將是一個高度務實的比較。

Our next question comes from Jason McCarthy with Maxim Group.

我們的下一個問題來自 Maxim Group 的 Jason McCarthy。

This is Michael Okunewitch on the line for Jason McCarthy. So I guess to start off, I'd just like to see if you could provide a bit of commentary on why you think we're seeing some stronger tracks in terms of Spravato? Is this owing largely to greater acceptance of interventional approaches, the maturing delivery infrastructure or the maturing reimbursement environment? I'd just like to see if I can get your take on that.

我是麥可‧奧庫內維奇，正在接聽傑森‧麥卡錫的電話。所以我想首先，我想看看您是否可以提供一些評論，解釋為什麼您認為我們在 Spravo 方面看到了一些更強的曲目？這主要是由於對介入方法的接受度提高、交付基礎設施的成熟還是報銷環境的成熟？我只是想看看我是否能得到你的看法。

I think all 3, will be frankly the answer. And I think a couple of things. All of those are relevant. Growth of infrastructure, increasing acceptance by psychiatrists and other health care providers as well as, I think, what is a broadly favorable reimbursement landscape for Spravato.

坦白說，我認為這三個都是答案。我認為有幾件事。所有這些都是相關的。基礎設施的發展、精神科醫生和其他醫療保健提供者的接受度不斷提高，以及我認為對 Spravo 來說普遍有利的報銷前景。

I think the other element though is that acceptance is actually driven by the results that people are seeing and the fact that results typically seem to be stronger than they perhaps were in the clinical trial. So what was seen as marginal efficacy in the trial has actually translated into better results in the real world and greater stickiness that's the additional factor, I would add.

我認為另一個因素是，接受度實際上是由人們看到的結果所驅動的，而且結果通常似乎比臨床試驗中的結果更強。因此，我想補充說，試驗中被視為邊際功效的東西實際上轉化為現實世界中更好的結果和更大的黏性，這是額外的因素。

I think the clinical experience certainly that I had with esketamine in the past is just the speed of response and the completeness of the response. That is very, very striking to clinicians. And I think one scene, you don't really forget it. And I think that's the impact. (inaudible) don't really capture it. When you see the patients live, you get a sense of their recovery and their joy to be relieved of their symptoms. That's very special, and that drives the uptake of these fast-acting drugs.

我認為我過去使用艾氯胺酮的臨床經驗當然就是反應速度和反應的完整性。這對臨床醫生來說非常非常引人注目。我認為有一個場景，你不會真正忘記它。我認為這就是影響。 （聽不清楚）並沒有真正捕捉到它。當你看到病人活著時，你會感受到他們的康復和症狀緩解的喜悅。這是非常特別的，它推動了這些速效藥物的吸收。

And then just one more kind of a housekeeping question, and I'll hop back in the queue. I'd just like to see if you could remind us how much remains on your ATM?

然後再問一種內務問題，我就會跳回隊列。我想看看您能否提醒我們您的 ATM 上還剩多少錢？

Sure. So the full ATM was $150 million. And since inception, we raised about $28 million. So that would be about $122 remaining.

當然。所以 ATM 機的總金額為 1.5 億美元。自成立以來，我們籌集了約 2800 萬美元。這樣大約還剩下 122 美元。

All right. Congratulations on the progress this quarter.

好的。恭喜本季取得的進展。

There are no further questions. I'd like to turn the call back over to management for any closing remarks.

沒有其他問題了。我想將電話轉回管理層以供結束語。

Thanks very much. So thank you, everyone, for your participation on today's call. As you heard and came through the question, this has been a strong quarter for us. Excellent progress in terms of the Phase III trials being underway, a fair amount of interesting new clinical data being published. Also, the significant moves we have made to extend our financial runway through both the use of the ATM and signing the debt facility with Hercules.

非常感謝。謝謝大家參加今天的電話會議。正如您聽到並回答這個問題一樣，這對我們來說是一個強勁的季度。正在進行的 III 期試驗取得了巨大進展，發布了大量有趣的新臨床數據。此外，我們還採取了重大舉措，透過使用 ATM 和與 Hercules 簽署債務融資來擴展我們的財務跑道。

So we're in a strong position going forward with a strong balance sheet, and we'll look forward to reporting back to you on continued progress in the next quarter. Thanks very much all for your time today.

因此，我們在未來的發展中處於有利地位，擁有強大的資產負債表，我們期待向您報告下一季的持續進展。非常感謝大家今天抽出時間。

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

感謝您的參與。這確實結束了程序，您現在可以斷開連接。大家，祝你有美好的一天。