Definium Therapeutics Inc (DFTX) 2026 Q1 法說會逐字稿

Good afternoon. I'm Gita Jain, Head of Investor Relations, and thank you for joining us today for Definium Therapeutics' first quarter 2026 financial results and recent highlights conference call. (Event Instructions) This webcast is live on the Investors section of Definium's website at definiumtx.com, and a replay will be available after the webcast.

各位下午好。我是 Gita Jain，投資人關係主管，感謝各位今天參加 Definium Therapeutics 2026 年第一季財務結果與近期重點的電話會議。（活動說明）本次網路直播可於 Definium 官網 definiumtx.com 的「投資人」專區收看，直播結束後亦將提供重播。

Leading the call today will be Rob Barrow, our Chief Executive Officer, who is joined by Dr. Dan Karlin, our Chief Medical Officer; Brandi Roberts, our Chief Financial Officer; and Matt Wiley, our Chief Commercial Officer.

今天的會議將由我們的執行長 Rob Barrow 主持，並由我們的醫務長 Dan Karlin 博士；財務長 Brandi Roberts；以及商務長 Matt Wiley 一同參與。

During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runaway, and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC and the applicable Canadian securities regulators, including our annual report on Form 10-K and our Form 10-Q filed today.

在今天的會議中，我們將發表若干前瞻性陳述，包括但不限於：關於我們產品候選藥物的潛在安全性、有效性，以及法規與臨床進展；我們預期的現金可支撐期間；以及我們未來的預期、計畫、合作夥伴關係與前景等。這些陳述受多項風險影響，例如市場狀況變化，以及研發與法規核准流程相關的困難。上述及其他風險因素已載於我們向美國證券交易委員會（SEC）及適用的加拿大證券監理機關提交的文件中，包括我們的 Form 10-K 年報，以及我們今天提交的 Form 10-Q。

Forward-looking statements are based on assumptions, opinions, and estimates of management at the date the statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of Definium's normal course of business.

前瞻性陳述係基於管理層於陳述作成當日的假設、觀點與估計，包括：不會發生我們向 SEC 及適用的加拿大證券監理機關提交文件中所述之風險與不確定性，或不會發生其他超出 Definium 正常營運範圍的重大事件。

We are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 7, 2026. Definium disclaims any obligation to update such statements, even if management's views change except as required by law. With that, let me turn the call over to Rob.

我們提醒各位不要過度依賴這些前瞻性陳述；其係截至今日（2026 年 5 月 7 日）作成。除法律要求外，即使管理層觀點改變，Definium 亦不承擔更新此等陳述之任何義務。接下來我把電話交給 Rob。

Thank you, Gita, and thank you all for joining us today. The first quarter of 2026 marked a strong start to what we believe will be a pivotal year for Definium. We remain highly focused on disciplined execution as we have advanced our late-stage clinical programs, prepared for multiple near-term data readouts, and continue to build an incredible team to lead our potential commercialization efforts.

謝謝你，Gita，也謝謝各位今天加入我們。2026 年第一季為我們帶來強勁的開局，我們相信這將是 Definium 的關鍵一年。我們仍高度專注於有紀律的執行：推進我們的後期臨床計畫、為多項近期數據讀出做準備，並持續打造一支卓越團隊，以領導我們潛在的商業化工作。

As we discussed at our Investor and Analyst Day a few weeks ago, Definium is entering a period of meaningful clinical inflection. Our lead program, DT120 ODT, is advancing with four ongoing Phase 3 studies across major depressive disorder, or MDD, and generalized anxiety disorder, or GAD, with top-line data from Emerge expected later this quarter, followed by Voyage and Panorama in the third quarter.

正如我們在幾週前的投資人與分析師日所討論，Definium 正進入一段具有實質臨床拐點的時期。我們的主力計畫 DT120 ODT 正在推進，於重度憂鬱症（MDD）與廣泛性焦慮症（GAD）兩大適應症中共有四項進行中的第三期研究；其中 Emerge 的主要結果預計於本季稍晚公布，接著第三季將公布 Voyage 與 Panorama。

Our Phase 3 programs are designed to evaluate outcomes that we believe would represent a meaningful advance for patients, physicians, and the field of psychiatry. These include not only the magnitude of symptom improvement, but also the safety, tolerability, and durability of response following a single administration, dimensions we believe will be critical in differentiating DT120 ODT in today's treatment landscape.

我們的第三期計畫旨在評估我們認為可為病患、醫師與精神醫學領域帶來實質進展的結果。這些結果不僅包括症狀改善的幅度，也包括單次給藥後的安全性、耐受性與反應持久性；我們相信這些面向將是 DT120 ODT 在當前治療版圖中形成差異化的關鍵。

We're also encouraged by the increasing recognition of the significant unmet need in these indications. With three Phase 3 readouts anticipated across two of the largest indications in psychiatry, Definium is approaching an important moment for the company and for the patients we aim to help.

我們也受到鼓舞，因為外界對這些適應症中重大未被滿足醫療需求的認知正持續提升。隨著預期在精神醫學兩個最大適應症中將有三項第三期讀出，Definium 正接近公司與我們希望幫助的病患都非常重要的時刻。

With breakthrough therapy designations for DT120 and GAD, we have established a constructive working relationship with FDA and will move as efficiently as possible towards an NDA submission, subject to positive physical data.

DT120 在 MDD 與 GAD 皆獲得突破性療法認定後，我們已與 FDA 建立具建設性的合作關係，並將在臨床數據為正面的前提下，盡可能高效率地推進至 NDA 申請。

Beyond our ongoing Phase 3 programs, we plan to expand the development of DT120 ODT into additional indications, including post-traumatic stress disorder, or PTSD, with the planned initiation of our Haven study in 2027. We believe this represents an important opportunity to further leverage the potential of DT120 across areas of high unmet need.

除進行中的第三期計畫外，我們也計畫將 DT120 ODT 的開發擴展至其他適應症，包括創傷後壓力症候群（PTSD），並預計於 2027 年啟動 Haven 研究。我們相信這代表一項重要機會，可進一步在高未滿足需求領域發揮 DT120 的潛力。

Overall, we continue to believe in DT120 ODT as a potential best-in-class product candidate, one that could help redefine what's possible for the millions of people living with depression, anxiety, and PTSD who remain underserved by existing treatments.

整體而言，我們仍相信 DT120 ODT 具備成為同類最佳（best-in-class）產品候選藥物的潛力，並可能協助重新定義對數以百萬計、仍未能從現有治療中獲得充分照護的憂鬱、焦慮與 PTSD 患者而言，什麼才是可能的。

I'll now turn it over to Dan to go into more detail on our clinical programs. Dan?

接下來我把時間交給 Dan，請他更詳細說明我們的臨床計畫。Dan？

Thanks, Rob. I'll provide an update on the status of our clinical programs with a focus on where each of our late-stage studies stands today and how those studies were designed to assess what we believe would constitute a clinically meaningful outcome.

謝謝，Rob。我將更新我們臨床計畫的最新狀態，重點說明各項後期研究目前的進展，以及這些研究如何被設計用以評估我們認為可構成具臨床意義結果的指標。

Starting with DT120 ODT, our lead program continues to advance across Phase 3 studies in major depressive disorder, generalized anxiety disorder, and now post-traumatic stress disorder. In Emerge, our first Phase 3 study in MDD, enrollment is complete with 149 participants. We are now in the final stages of trial execution and data preparation, and we remain on track to report top-line results later this quarter.

先從 DT120 ODT 開始，我們的主力計畫持續推進，涵蓋重度憂鬱症、廣泛性焦慮症，以及現在的創傷後壓力症候群之第三期研究。在 Emerge（我們在 MDD 的第一項第三期研究）中，已完成收案，共 149 名受試者。我們目前正處於試驗執行與數據準備的最後階段，並仍按計畫於本季稍晚公布主要結果。

In GAD, we are rapidly approaching top-line data readouts for our two pivotal studies, Voyage and Panorama. Enrollment in Voyage is complete with 214 participants. We have exceeded our updated enrollment target of 200 participants in Panorama and expect to complete enrollment this month.

在 GAD 方面，我們兩項關鍵性研究 Voyage 與 Panorama 的主要數據讀出正快速接近。Voyage 已完成收案，共 214 名受試者。Panorama 的收案人數已超過我們更新後的目標 200 名，並預期於本月完成收案。

We continue to expect top-line data from Voyage early in the third quarter and Panorama late in the third quarter. Across our pivotal program, our focus has been on rigorous execution, data quality and consistency across studies and sites. These are large, well-controlled trials designed to evaluate the magnitude of improvement alongside safety and durability of response following a single administration of DT120 ODT.

我們仍預期 Voyage 的主要數據將於第三季初公布，Panorama 則於第三季末公布。在整體關鍵性計畫中，我們的重點一直是嚴謹執行、數據品質，以及跨研究與各試驗中心的一致性。這些都是大型、良好控制的試驗，旨在評估改善幅度，同時評估單次給予 DT120 ODT 後的安全性與反應持久性。

Given our confidence in the clinical profile of DT120 and the strong evidence we have generated to date, our approach is uniquely designed to establish the durability of a single treatment for at least 12 weeks. Our Phase 3 studies in MDD and GAD were initially powered to detect a placebo-adjusted difference of 5-points.

基於我們對 DT120 臨床特徵的信心，以及迄今所累積的強力證據，我們的策略設計具有獨特性，旨在證實單次治療的效果可至少維持 12 週。我們在 MDD 與 GAD 的第三期研究最初皆以可偵測安慰劑校正後 5 分差異為統計效能（power）設計目標。

As part of the protocol-specified design, we conducted sample size re-estimations in Voyage and Panorama. These analyses were performed without unblinding treatment assignments and were intended to assess key nuisance parameters, standard deviation and dropout rates, to support the maintenance of the intended statistical power.

依照方案（protocol）所規定的設計，我們在 Voyage 與 Panorama 進行了樣本數重新估算。這些分析在不揭盲治療分派的情況下進行，目的在於評估關鍵的干擾參數（nuisance parameters），包括標準差與退出率，以支持維持原先預期的統計效能。

Based on these blinded analyses, which were conducted when half of participants reached the 12-week time point, Voyage and Panorama are now powered at 99% or greater to detect a 5-point placebo-adjusted difference, assuming these nuisance parameters remain consistent in the final study analysis.

根據這些盲態分析（於半數受試者達到 12 週時間點時進行），在假設最終研究分析中上述干擾參數仍保持一致的前提下，Voyage 與 Panorama 目前的統計效能已達 99% 或更高，可偵測安慰劑校正後 5 分差異。

For Emerge, the study was powered at 80% to detect a 5-point placebo-adjusted change, with statistical significance expected at a little over a 3-point difference based on certain nuisance parameter assumptions. We selected this level of power intentionally as we believe a 3-point or more difference represents an appropriate threshold for clinical meaningfulness in MDD.

至於 Emerge，本研究以 80% 的統計效能設計，用以偵測安慰劑校正後 5 分的變化；並在某些干擾參數假設下，預期在略高於 3 分差異時即可達到統計顯著性。我們刻意選擇此一效能水準，因為我們認為在 MDD 中，3 分或以上的差異代表合適的臨床意義門檻。

It's also worth noting that Emerge has a six-week primary endpoint compared to 12 weeks for Voyage and Panorama, mitigating the risk of an elevated dropout rate in the primary analysis.

另外值得注意的是，Emerge 的主要終點為 6 週，相較於 Voyage 與 Panorama 的 12 週，可降低主要分析中退出率偏高的風險。

Additionally, while the studies were powered to detect a 5-point difference, we believe that a placebo-adjusted improvement of 4-points or greater 6 to 12 weeks after treatment would compare favorably to currently available treatments for GAD and MDD and other product candidates in the psychedelic category.

此外，雖然這些研究的設計效能是為了偵測 5 分差異，但我們相信，在治療後 6 至 12 週達到安慰劑校正後 4 分或以上的改善，將可與目前可用於 GAD 與 MDD 的治療，以及迷幻藥物類別中的其他產品候選藥物相比，展現有利的競爭力。

Durability remains a particularly important dimension for psychedelics. In our Phase 2 program in GAD, DT120 demonstrated durability through 12 weeks following a single administration of 100 micrograms.

對於迷幻藥物而言，持久性仍然是一個特別重要的面向。在我們針對廣泛性焦慮症（GAD）的第2期計畫中，DT120 在單次給藥 100 微克後，展現了可持續長達 12 週的效果。

Our Phase 3 trials are designed to further evaluate consistency and duration of response over time. Through Part B of these studies, patients are followed for up to one year, which we believe will provide important information to inform potential labeling, including how frequently treatment may be needed.

我們的第3期試驗旨在進一步評估反應隨時間的穩定性與持續時間。在這些研究的 B 部分中，患者將被追蹤長達一年，我們相信這將提供重要資訊，以支持潛在標示內容的制定，包括可能需要多頻繁進行治療。

Beyond DT120, we are excited to also be advancing our Phase 2 study of DT402 in autism spectrum disorder, or ASD. DT402, the R-enatiomer of MDMA, has shown promising pro-social effects with a potentially favorable tolerability profile. We are developing DT402 to target the core characteristics of ASD, specifically addressing social communication that is central to the experience of the disorder.

除了 DT120 之外，我們也很振奮能推進 DT402 在自閉症光譜障礙（ASD）中的第2期研究。DT402 為 MDMA 的 R-對映異構體，已顯示出具前景的促進親社會行為效果，且可能具有較佳的耐受性特徵。我們正在開發 DT402，以鎖定 ASD 的核心特徵，特別是針對該疾病體驗中至關重要的社交溝通問題。

We see this program as a significant opportunity given the high unmet need, the increasing prevalence of ASD, and no FDA-approved therapies that specifically address these core characteristics.

鑑於高度未被滿足的醫療需求、ASD 盛行率持續上升，以及目前沒有任何 FDA 核准且能專門針對這些核心特徵的療法，我們認為此計畫是一項重大機會。

As we look ahead, the next five months represent a significant culmination of thoughtful trial design, disciplined execution, and years of work focused on addressing some of the most pressing unmet needs in psychiatry. With multiple Phase 3 readouts approaching, we believe we are well-positioned to deliver decisive data on DT120.

展望未來，接下來五個月將是我們審慎的試驗設計、嚴謹的執行，以及多年來致力於解決精神醫學領域最迫切未滿足需求工作的重大成果匯聚。隨著多項第3期讀出即將到來，我們相信我們已具備良好條件，能就 DT120 提供具決定性的數據。

With that, I'll turn the call over to Matt to discuss our commercial strategy and the broader treatment landscape. Matt?

接下來我把電話交給 Matt，請他談談我們的商業策略以及更廣泛的治療版圖。Matt？

Thanks, Dan. I'll spend a few minutes discussing the commercial opportunity for DT120, building on what we shared at our Investor and Analyst Day in April. As we discussed, GAD and MDD represent very large and persistently underserved markets. Many existing medicines are constrained by delayed onset, partial or inconsistent efficacy, and tolerability issues that drive high discontinuation rates.

謝謝，Dan。我將花幾分鐘討論 DT120 的商業機會，並延續我們在四月投資人與分析師日所分享的內容。如同我們所討論的，廣泛性焦慮症（GAD）與重度憂鬱症（MDD）代表非常龐大且長期未被充分服務的市場。許多既有藥物受限於起效延遲、療效部分或不一致，以及耐受性問題，導致高停藥率。

Across this landscape, roughly 4.2 million US adults have cycled through two or more treatments without sustained benefits, a population that sits at the center of our initial launch focus. We believe that these patients and the physicians treating them are actively looking for a next-generation option that works differently and can deliver durable improvement without the need for chronic daily dosing.

在此治療版圖中，約有 420 萬名美國成年人已在兩種或以上治療間反覆嘗試但未獲持續效益；這一族群正是我們初期上市聚焦的核心。我們相信，這些患者以及治療他們的醫師，正積極尋找一種新一代選項：作用機轉不同，且能在不需要長期每日用藥的情況下帶來持久改善。

To put the scale of this opportunity in perspective and using Spravato's average annual price as a surrogate, capturing just 1% of the total addressable market in these indications represents the potential for a roughly $2 billion annual revenue opportunity. Our targeting model is built directly around this substantial unmet need.

為了讓大家理解這項機會的規模，若以 Spravato 的平均年度價格作為替代指標，在這些適應症中即使僅取得可服務市場（TAM）的 1%，也可能代表約 20 億美元的年營收機會。我們的目標鎖定模型正是直接圍繞這項龐大的未滿足需求所建立。

We have identified high-volume healthcare practitioners, primarily psychiatrists and psychiatric nurse practitioners, who manage concentrated populations of these specific patients. These high-volume prescribers are located within psychiatric practices, behavioral health networks, and select integrated health systems, where these patients most often receive care.

我們已辨識出高量能的醫療照護提供者，主要為精神科醫師與精神科護理師執業者，他們管理著高度集中的此類特定患者族群。這些高量能處方者多位於精神科診所、行為健康網絡，以及部分整合式醫療體系中，而患者最常在這些場域接受照護。

We have mapped these priority targets in detail and plan to focus our launch efforts on engaging these clinicians, particularly those who have experience with or have expressed interest in novel in-office interventions and supported by care teams capable of monitoring patients during the dosing day. We believe this approach will enable us to reach a meaningful number of appropriate patients from the outset while establishing a strong foundation for scalable adoption.

我們已詳細繪製這些優先目標，並計畫將上市推廣重點放在與這些臨床人員互動，特別是那些對新型院內介入治療有經驗或表達興趣者，且其照護團隊具備在給藥當天監測患者的能力。我們相信此方法將使我們從一開始就能觸及相當數量的合適患者，同時建立可擴展採用的堅實基礎。

One of the points we highlighted at our Investor and Analyst Day is the growing awareness of DT120 among clinicians. Through ongoing engagement, we've seen increasing familiarity with its clinical profile and strong interest as a potential new treatment option that could help patients move beyond therapies that are no longer providing adequate or lasting relief.

我們在投資人與分析師日強調的一點，是臨床人員對 DT120 的認知度正在提升。透過持續互動，我們看到他們對其臨床特徵愈加熟悉，並對其作為潛在新治療選項展現高度興趣，該選項可協助患者走出那些已無法提供足夠或持久緩解的療法。

We also shared data showing that patients discontinue current treatments at a high rate, often due to lack of efficacy or tolerability. These challenges are especially pronounced among patients who have been failed by two or more prior therapies, reinforcing the substantial opportunity for differentiated innovations like DT120.

我們也分享了數據，顯示患者以高比率停止目前治療，常見原因是療效不足或耐受性不佳。在曾經接受兩種或以上既往療法仍失敗的患者中，這些挑戰尤其明顯，進一步凸顯像 DT120 這類具差異化創新的龐大機會。

Our commercial strategy is shaped by these realities. We are focused on how this therapy can be introduced in a way that is scalable, accessible, and practical within real-world care settings without the necessity of chronic interventions.

我們的商業策略正是由這些現實所塑造。我們聚焦於如何以可擴展、可及且在真實世界照護場域中可行的方式導入此療法，而不必依賴長期、持續性的介入。

A key element of our planning includes a centralized hub support model and additional field support to enable a frictionless process of adoption and delivery. In parallel, we continue to engage with physicians, payers, and other stakeholders to better understand decision drivers around adoption, patient identification, and reimbursement frameworks.

我們規劃中的一個關鍵要素，是建立集中式樞紐（hub）支援模式，並搭配額外的外勤支援，以促成無摩擦的採用與交付流程。同時，我們持續與醫師、支付方及其他利害關係人互動，以更深入了解採用決策的驅動因素、患者辨識方式，以及給付／報銷架構。

By pairing a well-articulated unmet need in a receptive market with our disciplined, patient-centric commercial strategy, Definium is very well positioned as we near pivotal data readouts and advanced DT120 towards potential commercial launch.

透過將明確闡述的未滿足需求、具接受度的市場，與我們嚴謹、以患者為中心的商業策略相結合，隨著關鍵性數據讀出臨近並推進 DT120 邁向潛在商業上市，Definium 已處於非常有利的位置。

With that, I'll turn it over to Brandi to discuss our financial results.

接下來我把時間交給 Brandi，請她說明我們的財務結果。

Thanks, Matt. Before walking through our financial results, I want to briefly set the context for how we're thinking about capital deployment as we move through an important phase for Definium.

謝謝，Matt。在帶大家檢視財務結果之前，我想先簡要說明我們在 Definium 進入一個重要階段時，對資本部署的思考脈絡。

As we entered 2026, we were pleased to have the financial flexibility to accelerate several key initiatives in parallel, including ongoing Phase 3 execution, NDA preparation activities, market access priorities, and continued engagement with key opinion leaders and leading practitioners.

進入 2026 年之際，我們很高興擁有足夠的財務彈性，得以並行加速多項關鍵計畫，包括持續執行第3期試驗、NDA 申請準備工作、市場准入優先事項，以及持續與關鍵意見領袖與領先臨床實務者互動。

These investments are intended to support our path forward, and if DC120 is approved, position the company to be well prepared for a robust, thoughtful commercial launch. We've also been encouraged by the continued evolution of our investor base in 2026, with strong engagement from existing shareholders and growing interest from new investors as we make progress across our programs. We believe this reflects increasing recognition of the opportunity ahead, as well as confidence in our disciplined approach to execution and capital allocation.

這些投資旨在支持我們後續的推進路徑，並在 DC120 獲核准的情況下，使公司能為一場強勁且周全的商業上市做好充分準備。我們也受到鼓舞的是，2026 年我們的投資人結構持續演進，既有股東保持高度參與，且隨著我們各項計畫取得進展，新投資人的興趣也在增加。我們相信這反映出市場對前方機會的認知提升，以及對我們在執行與資本配置上嚴謹作風的信心。

I'll now turn to our financial results for Q1 2026, which are detailed in the earnings release we issued this afternoon.

接下來我將說明我們 2026 年第一季的財務結果，相關細節已載於我們今天下午發布的財報新聞稿中。

Research and development expenses were $41.5 million, compared to $23.4 million for Q1 2025. The net increase of $18.1 million was primarily driven by increases of $15.2 million in DT120 program expenses, $3.2 million in internal personnel costs as a result of expanding our R&D capabilities. And $0.3 million in DT402 program expenses, partially offset by a $0.6 million reduction in preclinical and other program expenses.

研發費用為 4,150 萬美元，較 2025 年第一季的 2,340 萬美元增加。淨增加 1,810 萬美元，主要由 DT120 計畫費用增加 1,520 萬美元、因擴充研發能力而使內部人員成本增加 320 萬美元所帶動。以及 DT402 計畫費用增加 30 萬美元；部分被臨床前及其他計畫費用減少 60 萬美元所抵銷。

For Q1 2026, general and administrative expenses were $17.7 million, compared to $8.8 million for Q1 2025. The net increase of $8.9 million was primarily due to increases of $3.9 million in stock-based compensation expenses, $1.4 million in personnel-related expenses, $1.4 million in commercial preparedness-related expenses, $1.4 million in corporate and government affairs expenses and $1.2 million in legal and patent expenses, partially offset by a $0.4 million reduction in other miscellaneous administrative expenses.

2026 年第一季，一般及行政費用為 1,770 萬美元，較 2025 年第一季的 880 萬美元增加。淨增加 890 萬美元，主要由股份基礎給付費用增加 390 萬美元、人員相關費用增加 140 萬美元、商業化準備相關費用增加 140 萬美元、公司與政府事務費用增加 140 萬美元，以及法律與專利費用增加 120 萬美元所致；部分被其他雜項行政費用減少 40 萬美元所抵銷。

The year-over-year increase in G&A expenses reflects deliberate investment to support a more mature organization as we prepare for our anticipated Phase 3 top-line data readouts and potential commercialization.

一般及行政費用的年增，反映出我們為支持更成熟的組織所做的刻意投資，因我們正為預期的第3期主要數據讀出以及潛在商業化做準備。

Overall, our R&D and G&A expenses for the first quarter were in line with our internal expectations as we continue to make meaningful progress across the DT120 and DT402 programs.

整體而言，第一季的研發與一般及行政費用符合我們的內部預期，因我們持續在 DT120 與 DT402 計畫上取得具意義的進展。

Net loss for Q1 2026 was $77.1 million, compared to $23.3 million for Q1 2025. As a reminder, our net loss can be significantly impacted by changes in the fair value of our 2022 USD financing warrants, which are mark-to-market each quarter.

2026 年第一季淨損為 7,710 萬美元，較 2025 年第一季的 2,330 萬美元增加。提醒一下，我們的淨損可能會受到 2022 年美元融資認股權證公允價值變動的顯著影響，該等權證每季按市價（mark-to-market）重新衡量。

For Q1 2026, the impact on net loss from the change in fair value was $20 million, reflecting an increase in our share price from $13.39 at December 31, 2025 to $18.90 at March 31, 2026.

就 2026 年第一季而言，公允價值變動對淨虧損的影響為 2,000 萬美元，反映我們股價自 2025 年 12 月 31 日的 13.39 美元上升至 2026 年 3 月 31 日的 18.90 美元。

Turning to the balance sheet, we ended Q1 2026 with $373.4 million in cash, cash equivalents and investments. We believe our capital position provides sufficient runway to fund planned operations through multiple anticipated clinical readouts and into 2028.

接著看資產負債表，我們在 2026 年第一季末持有 3.734 億美元的現金、約當現金及投資。我們相信，我們的資本狀況提供了充足的資金跑道，可支應規劃中的營運，涵蓋多項預期的臨床讀出，並延伸至 2028 年。

2026 is shaping up to be a data-rich and strategically important year for Definium. Our financial position allows us to remain focused on disciplined execution while maintaining the flexibility needed to support our priorities and continue building long-term value for shareholders. With that, I'll turn the call back to Rob.

2026 年正逐步成為 Definium 一個資料豐富且具策略重要性的一年。我們的財務狀況使我們能在維持支持優先事項所需彈性的同時，持續專注於紀律性的執行，並為股東持續打造長期價值。接下來我把電話交回給 Rob。

Thanks, Brandi. After years of thoughtful trial design and focused execution, we are entering a period of numerous pivotal milestones that we expect we'll define the next chapter for Definium in our broader field. As we mark Mental Health Awareness Month, the urgency of advancing new treatment options and the responsibility we carry for patients feels especially pronounced.

謝謝，Brandi。經過多年審慎的試驗設計與聚焦的執行，我們正進入一段擁有多項關鍵里程碑的時期；我們預期這些里程碑將在更廣泛的領域中，為 Definium 定義下一個篇章。值此心理健康意識月之際，推進新的治療選項的迫切性，以及我們對病患所肩負的責任，顯得格外強烈。

Before we close, I want to say thank you to our incredible team, the investigators and their teams, and to the hundreds of patients who have made this work possible.

在結束之前，我想向我們出色的團隊、研究者及其團隊，以及讓這項工作得以實現的數百位病患致上謝意。

With that, we're happy to take your questions.

接下來，我們很樂意回答各位的問題。

(Operator Instructions)

（接線員指示）

(inaudible)

（聽不清楚）

I'm sorry, you cut out for a second. This is for Paul.

不好意思，你剛剛斷線了一下。這題是問 Paul 的。

Yes, your line is now open, Paul.

好的，Paul，你的線路現在已開通。

Hi, this is Emily on for Paul Matteis at Stifel. We just had a quick question on assuming, you have success in MDD and anxiety this year. Could you maybe speak more to yourself around how much long-term safety and retreatment data you would need for approval? And in these long-term data, would patients need to retreat a certain amount of time to count as a long-term exposure for safety? Thank you.

嗨，我是 Stifel 的 Emily，代替 Paul Matteis 發問。我們有個簡短問題：假設你們今年在 MDD 與焦慮症方面取得成功。你能否多談談，為了獲得核准，你們需要多少長期安全性與再治療（retreatment）資料？另外，在這些長期資料中，病患是否需要在一定期間內接受一定次數的再治療，才會被計入安全性的長期暴露？謝謝。

Great. Yeah, thanks so much, Emily. I will speak briefly to this and then turn it over to Dan to maybe elaborate. We've had a great dialogue with FDA over the past several years and obviously building towards an eventual plan for an NDA submission, so just to positive data and all that to happen to get ready for an NDA, which we're very well positioned for.

很好。是的，非常感謝你，Emily。我先簡要回應，接著請 Dan 可能再補充說明。過去幾年我們與 FDA 一直保持良好的對話，並且顯然是在為最終的 NDA 送件計畫做準備；因此，只要有正向數據等一切條件到位、準備好 NDA，我們目前的布局非常有利。

In terms of safety data and what's required, we feel really comfortable with the completion of Part A and the data that we'll have available at the time of filing and at various milestones between here and there, we have sufficient safety exposure, both single dose and over longer periods of time.

就安全性資料與所需要求而言，我們對 A 部分（Part A）的完成以及在申報時可取得的資料感到非常有信心；在從現在到那時的各個里程碑，我們也將具備足夠的安全性暴露資料，涵蓋單次給藥以及較長期間的暴露。

Of course, the interesting dynamic with drugs that you don't have to take continuously or daily or in a very short, fixed interval, like the treatments we have today, is that treatment patterns that diverge across different patient populations or different patients. To mean that six months of treatment can look like one dose or multiple doses. And so something we're really interested in characterizing, of course, in our Phase 3 program. But regardless, we feel very well positioned with the studies we're conducting that we'll be in a great position to move forward. So we're depositing Phase 3 data.

當然，對於不需要連續、每日或以很短固定間隔服用的藥物——不同於我們今天的治療——有一個有趣的動態：不同病患族群或不同個體之間的治療模式會出現分歧。這意味著六個月的治療可能看起來像是一次給藥，也可能是多次給藥。因此，這也是我們在第三期計畫中非常有興趣加以刻畫的部分。但無論如何，我們認為以目前正在進行的研究，我們處於非常有利的位置，能夠順利推進。所以我們正在累積第三期資料。

Dan, you want to add any color to that?

Dan，你要補充一些看法嗎？

Yeah, I mean, I guess I could elaborate just a tiny bit on part of the value of the Part Bs of these studies where we're able to deliver triggered treatment based on people having moderate symptoms of GAD or MDD or worse, moderate or severe. And the value of that is multifold really, which is that, one, it helps keep people in the Part A of the study, as you saw from our announced sample size re-estimation outputs, our dropout rates are really quite remarkably low in part. Because people know that they have this opportunity if they're still safe to get open-label treatment in Part B.

是的，我想我可以就一點點補充：這些研究的 B 部分（Part B）其中一個價值在於，我們能在受試者出現中度 GAD 或 MDD 症狀（或更嚴重，中度或重度）時，提供觸發式治療。這樣做的價值其實是多方面的：第一，它有助於讓受試者留在研究的 A 部分（Part A）；正如你從我們公布的樣本數重新估算結果所看到的，我們的退出率確實相當低，部分原因就在於此。因為受試者知道，只要仍符合安全條件，他們在 B 部分有機會接受開放標籤治療。

The ability to follow folks long-term for up to a year after their initial blinded dose is another advantage of these studies, right? So, for folks who get to mild illness or better, we just get to keep watching them in that initial controlled blinded state unless they get sick again and until they get sick again, if they in fact do. So that's another advantage.

此外，能在初次盲態給藥後，對受試者進行長期追蹤、最長可達一年，也是這些研究的另一個優勢，對吧？因此，對於病情改善到輕度或更好的受試者，我們可以在最初的受控盲態狀態下持續觀察他們，除非他們再次發病；直到他們再次發病（如果真的發生）。所以這也是另一項優勢。

And then as Robin said, in those Part Bs, we get to give up to four additional open-label treatments contingent on people developing moderate illness or worse. So that will give us the ability to start to really carefully characterize across these studies the patterns of treatment that emerge when treating people with moderate or worse symptoms, which maps pretty well onto what we think would likely happen in the real world if approved.

然後如 Robin 所說，在那些 B 部分中，若受試者出現中度或更嚴重的病情，我們最多可再給予四次額外的開放標籤治療。因此，這將使我們能夠在這些研究中開始非常仔細地刻畫：當以中度或更嚴重症狀治療受試者時，所呈現出的治療模式。

So with all of those data in hand, we're confident that we will have everything we need to both inform FDA and then, of course, to inform the clinical and patient community if we do get approved.

因此，當我們掌握所有這些資料後，我們有信心我們將具備一切所需，不僅能向 FDA 提供資訊，當然也能在若獲核准時，向臨床端與病患社群提供資訊。

Great. That's super helpful, and congrats on the quarter.

很好。這非常有幫助，恭喜本季表現。

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

Thanks. So just a couple for me. One in terms of the patient experience. In terms of patient monitoring, how confident are you that in practice only one dosing session monitor will be needed to monitor the patient? So that's number one, sort of a, I guess, answer related question on that front.

謝謝。我這邊有兩個問題。第一個是關於病患體驗。就病患監測而言，你們對於在實務上只需要一位給藥療程監測員來監測病患，有多大把握？這是第一個問題，算是與此相關的一個問題。

And then secondly, I have a question on the PTSD Haven study. Just a little bit of color, if you can, on the thought process behind running Haven is just a straight up active first placebo as opposed to including a low 50 microgram dose arm. Just love to get your thoughts on your thought process on that. Thanks.

第二個問題是關於 PTSD 的 Haven 研究。如果可以的話，想請你們多補充一些背景：為什麼 Haven 的設計是直接採用主動對照（active）加安慰劑，而不是納入一個低劑量 50 微克的組別？很想聽聽你們背後的思考。謝謝。

Thanks so much, David. Yeah, Dan, I'll turn it back over to you.

非常感謝你，David。是的，Dan，我把問題交回給你。

Yeah, great question. So the situation in the clinical trials, of course, is that per FDA direction, we have an in-person lead monitor and then a secondary monitor who can watch remotely via video. And that's been the condition for clinical trials based on FDA direction.

好的，這是個很好的問題。在臨床試驗中的情況當然是：依 FDA 指示，我們有一位現場的主要監測員，另有一位次要監測員可透過視訊遠端觀看。依 FDA 指示，這一直是臨床試驗的條件。

Throughout the trials, we have made every effort to collect regulatory grade data on what those monitors are doing to provide for assistance and comfort for the patients, up to and including what the role of that second monitor actually ends up being. All of this is in service of making the case that single monitor is absolutely something that should be enabled in the real world, that's our position.

在整個試驗過程中，我們已盡最大努力蒐集符合監管等級（regulatory grade）的資料，了解這些監測員在做什麼，以便為病患提供協助與舒適感；其中也包括第二位監測員最終實際扮演的角色。所有這些努力，都是為了支持我們的主張：在真實世界中應該允許單一監測員，這是我們的立場。

In the longer-term here, if you look at other therapies that have acute consciousness altering effects, things like monitoring ratios haven't been explicitly specified. At the end of the day, it's been left to clinical discretion and clinical judgment to ensure that the patients are safely monitored. Of course, there's some contents in existing REMS, and we'll expect to have content in our REMS that relate to monitoring.

從較長期來看，如果你觀察其他會造成急性意識改變效果的療法，監測人力配置比例並未被明確規定。歸根結底，通常是交由臨床裁量與臨床判斷，以確保病患受到安全監測。當然，現有的 REMS 中已有一些與監測相關的內容，而我們也預期在我們的 REMS 中會納入與監測相關的內容。

But with the evidence that we're accumulating along the way adheres to the evidence that we've been able to establish for what constitutes safety and efficacy.

但我們一路累積的證據，與我們已能建立的、關於何謂安全性與有效性的證據是一致的。

I can comment on PTSD as well, if you'd like, Rob.

如果你願意的話，Rob，我也可以談談 PTSD。

Yeah, please, that sounds great.

好啊，拜託，聽起來很棒。

Yeah, sure. So, across the Phase 3 program, we have combined studies, right? We've got studies with two arms and then in two cases we've added this lower enrolling 50 microgram confounding arm rate. And that's not an analytical arm, it's not an arm where we're interested in the performance of the 50 microgram drug. Rather those arms have existed to confound the understanding of people in the other arms as to what they got.

好的，當然。所以，在第三期計畫中，我們把研究合併來看，對吧？我們有兩組設計的研究，然後在其中兩項研究裡，我們另外加入了一個招募較少的 50 微克混淆組。那不是一個分析用的組別，也不是我們有興趣評估 50 微克藥物表現的組別。相反地，那些組別的存在，是為了混淆其他組別受試者對自己拿到什麼治療的判斷。

So in each case for GAD and MDD, our first study in the condition, we used a two-arm design with the inert placebo, which we continue to believe. The appropriate control condition for testing psychiatric medications, including DT120 and any other psychedelic for that matter.

因此，在 GAD 與 MDD 的每個情況下，我們在該適應症的第一項研究採用兩組設計，使用惰性安慰劑，而我們仍然相信，這是用來測試精神科藥物（包括 DT120 以及任何其他迷幻藥物）的適當對照條件。

So that's what we did in PTSD. We think head-to-head is the best way to establish evidence of efficacy. And as we gathered the accumulated evidence and as we're able to read out the evidence from these other three studies that we're conducting and ultimately from [Ascend], which we've guided starting imminently.

所以我們在 PTSD 也是這麼做的。我們認為頭對頭比較是建立有效性證據的最佳方式。而隨著我們累積證據、並且能讀出我們正在進行的另外三項研究的結果，最終也包括我們已指引將於近期啟動的 [Ascend]。

All of that will accumulate to help us understand what, if any, effect that 50-microgram dose arm has on the understanding of people in the other arms as to what dose of drug they got and whether they got a treatment dose or not, and also whether that has any effect on the measured outcomes.

所有這些都將累積起來，幫助我們理解：若有的話，50 微克劑量組對其他組別受試者判斷自己拿到何種劑量、以及是否拿到治療劑量的影響；同時也理解這是否會對量測到的結果造成任何影響。

So, as we gain more knowledge and information about the performance of these different studies with the different controlling and confounding conditions, that will allow us to think about future studies and the design of those studies. But for primary evidence of efficacy, we continue to believe head-to-head is the right control condition.

因此，隨著我們對這些不同研究在不同對照與混淆條件下的表現獲得更多知識與資訊，將使我們能思考未來研究以及其設計。但就主要的有效性證據而言，我們仍然相信頭對頭比較是正確的對照條件。

Okay, that's helpful. Thank you.

好的，這很有幫助。謝謝。

Andrew Tsai, Jefferies.

Jefferies 的 Andrew Tsai。

Hi, it's Brian Bolton here on Andrew Tsai. Just two questions. First, on patient journey, you mentioned Phase 3 would be a five to eight-hour patient journey for less than 12 hours in Phase 2. Can you talk a bit about what gets you closer to the five-hour journey as opposed to eight? What you need to establish with the FDM centers to make it happen?

嗨，我是 Brian Bolton，代 Andrew Tsai 提問。兩個問題。第一個，關於病患旅程（patient journey），你提到第三期會是 5 到 8 小時的病患旅程，而第二期則少於 12 小時。你能談談是什麼讓你們更接近 5 小時而不是 8 小時嗎？你們需要與 FDM 中心建立哪些條件才能實現？

And secondly, you'll see a response to the phase two, the GAD study. But actually very high compared to other GAP studies. How are you thinking, placebo might trend in the Phase 3s and then same goes for the Phase 3 MDD study as well? Thank you.

第二，你會看到第二期 GAD 研究的反應（response），但其實相較於其他 GAD 研究非常高。你們如何看待第三期中的安慰劑反應可能的走勢？第三期 MDD 研究也是同樣的問題。謝謝。

Yeah, thanks so much, Brian. So yeah, I think in terms of the first question and the criteria, some of the changes, and we highlighted this a few weeks ago at our event. Both formulation where we use an orally dissolving tablet in our Phase 3 program where we see faster absorption we think could translate into a better profile in terms of resolution of symptoms.

好的，非常感謝你，Brian。就第一個問題與相關標準而言，一些變更——我們在幾週前的活動中也強調過——包括劑型：在第三期計畫中我們使用口溶錠，吸收更快，我們認為這可能轉化為在症狀緩解方面更好的特徵。

But also the way we've approached this, it's been intentional from day one. We started with little information about the actual safety requirements and monitoring dynamics. In these studies, we're going into our Phase 2 program, we included a higher dose, 200-microgram dose in Phase 2, and therefore, conservatively and appropriately conservatively, extended the monitoring period in Phase 2 up to 12 hours and had an extremely lengthy set of criteria that were being measured to assess when patients could end the monitoring session.

但同時，我們採取這種做法從第一天起就是刻意為之。一開始我們對實際的安全性要求與監測動態資訊很少。在這些研究中，進入第二期計畫時我們納入了較高劑量（200 微克）於第二期，因此以保守、且適當地保守的方式，將第二期的監測時間延長至最多 12 小時，並設置了一套非常冗長的標準，用以評估病患何時可以結束監測時段。

Based on those learnings, based on those data from the Phase 2 study, we made revisions both, of course, to the formulation, but also to that procedure, that checklist we're using. And in Phase 3, we feel quite confident that we'll be moving in a shorter direction. That's what we're seeing so far.

基於這些學習、基於第二期研究的數據，我們做了修訂：當然包括劑型，也包括流程，也就是我們使用的那份程序清單（checklist）。而在第三期，我們相當有信心會朝更短的方向前進。這也是我們目前看到的情況。

And so -- I think that combined with the reality that the change from a 12-hour monitoring period to an eight-hour monitoring period being required for all the participants in the study was driven by discussions with FDA and based on those data. So we feel quite confident that we're heading in the right direction there.

因此——我想再加上這個現實：把監測期從 12 小時改為要求所有受試者都需 8 小時監測，是由與 FDA 的討論、並基於那些數據所驅動的。所以我們對於正朝正確方向前進相當有信心。

And that regardless, within that window, we see a really interactive clinical profile, one that means that patients aren't shuffled through and rushed out the door, and one that means that providers have a low turnover high efficiency delivery to those patients.

而且無論如何，在那個時間窗內，我們看到的是一個非常互動的臨床特徵：這意味著病患不會被草草帶過、匆忙送出門；也意味著提供者能以低周轉、高效率的方式為病患提供服務。

In terms of the second question, placebo response, you rightly noted we had a remarkably high placebo response in the phase two study. If we just focus on the GAD symptoms or GAD MA scores for a moment, what we saw there is, and this would be consistent across any modality and almost any scale, the fact that an 80% likelihood for patients to be receiving some dose of drug tends to drive up placebo response.

至於第二個問題，安慰劑反應，你說得對，我們在第二期研究中看到非常高的安慰劑反應。如果我們先聚焦在 GAD 症狀或 GAD MA 分數，我們看到的是——而且這在任何治療模式、幾乎任何量表上都一致——病患有 80% 的機率會收到某個劑量的藥物，往往會推高安慰劑反應。

We also saw that around a third of patients who received placebo guessed they were on drug. And so the presence of several lower doses likely really enhanced that placebo response. There are also dynamics with the dropout of patients where we didn't have anything to offer patients beyond the initial dose in Phase 2 that we now in Phase 3 have Part B and patients are guaranteed access to open-label drug if they continue on through the 12 weeks of the study.

我們也看到，大約三分之一接受安慰劑的病患猜測自己拿到的是藥物。因此，存在多個較低劑量很可能確實強化了安慰劑反應。另外也有與病患退出（dropout）相關的動態：在第二期中，除了初始劑量之外我們沒有其他可提供給病患的內容；而在第三期我們有 B 部分（Part B），病患若持續完成 12 週研究，將保證可取得開放標籤（open-label）藥物。

So all of those dynamics we think played a role in the Phase 2. And as we look to the Phase 3 program, having a lower allocation ratio and having a reason for patients to stay in the study should both reduce at least two or perhaps even below historical averages for the placebo response. That would be true, we'd expect in both GAD and in MDD.

所以我們認為，所有這些動態都在第二期中扮演了角色。而當我們看向第三期計畫時，更低的分配比例（allocation ratio）以及讓病患有理由留在研究中，兩者都應能降低安慰劑反應，至少降到歷史平均的水準，甚至可能更低。我們預期這在 GAD 與 MDD 都會成立。

I think we see this from other programs as well. We look at other studies in our category, we look at the pivotal studies for Spravato, we're seeing lower placebo responses than we have historically seen for antidepressant in daily drug studies. It wouldn't be surprising if we saw a lower-than-average placebo of a response across the phase three programs here. But given that we've exceeded such a high placebo by such a wide margin in phase two, we feel quite confident no matter what, we'll be in a great position ending in the phase three data.

我想我們也從其他計畫中看到這點。我們看同類別的其他研究、也看 Spravato 的關鍵性研究，看到的安慰劑反應低於我們在每日服用抗憂鬱藥研究中歷史上常見的水準。因此，如果我們在這裡的第三期計畫中看到低於平均的安慰劑反應，也不令人意外。但鑑於我們在第二期以很大的幅度超越了如此高的安慰劑反應，我們相當有信心，無論如何，在第三期數據結束時我們都會處於非常有利的位置。

Marc Goodman, Leerink.

Leerink 的 Marc Goodman。

Hi, good afternoon. This is Basma on for Marc. Thank you for taking our questions. Our first question is about the PTSD program. Can you remind us again of your convictions regarding the dose using the PTSD? Why do you think it's going to be efficacious? And also, can you remind us of the study powering assumptions?

嗨，午安。我是 Basma，代 Marc 提問。謝謝你們回答我們的問題。第一個問題關於 PTSD 計畫。你能再提醒我們一次，你們對 PTSD 所使用劑量的信念是什麼嗎？你們為什麼認為它會有效？另外，也請提醒我們研究的統計效力（powering）假設。

The second question is. Do you think for the submission in MDD or the GAD, whatever comes next, that you can leverage the safety data from the GAD? Or are you going to have to collect another set of exposure data in the relevant patient population? That's it for us. Thank you.

第二個問題是：你們認為在 MDD 或 GAD 的申報（submission）——不論接下來是哪一個——是否可以沿用（leveraging）GAD 的安全性數據？還是你們必須在相關病患族群中再收集另一套暴露（exposure）數據？我們的問題就這些。謝謝。

Yeah, I'll take the second first and then turn it over to Dan. We certainly expect to have exposure from physical studies and efficacy studies in any population that we're conducting research in, of course, but ICH guidelines for patient exposures aren't disease or disorder specific. So they would expect a huge population requirement like you see from [ICAT1] or anything.

好的，我先回答第二個問題，然後再交給 Dan。當然，我們確實預期在任何我們進行研究的人群中，都會有來自藥物動力學研究與療效研究的暴露數據，但 ICH 對於受試者暴露量的指引並不是針對特定疾病或障礙而定。因此，他們會期待像你在 [ICAT1] 或其他項目中看到的那種龐大受試者人數需求。

Dan, I'll turn it over to you to the other one.

Dan，另一個問題我就交給你了。

Yeah, so great question about PTSD and, having done our dose range finding study in phase two and getting great confidence in our Phase 3 dose. And dose in this formulation through some transitional PK work that we've done there, gave us the confidence to go forward in GAD and MDD. And as you note, the confidence also to go forward in PTSD with that dose, we have every reason to think that from a symptomatic perspective, from a disease definition overlap perspective, from a scale overlap perspective, that all of those come into alignment and that there's no real reason to think that the variations that make up these differently defined diseases, but that fundamentally have such tremendous overlap would call for any additional dose adjustment moving forward.

是的，關於 PTSD 的問題問得很好；我們已在第二期完成劑量範圍探索研究，並對第三期的劑量建立了很高的信心。而且，透過我們在此配方上所做的一些過渡性 PK 工作，這個劑量也讓我們有信心推進到 GAD 與 MDD。如你所指出的，這也讓我們有信心以同一劑量推進 PTSD；我們完全有理由相信，從症狀面、疾病定義的重疊性、量表的重疊性來看，這些都能一致對齊，沒有真正的理由認為，這些被不同方式定義、但本質上高度重疊的疾病之間的差異，會需要在後續再做任何額外的劑量調整。

So we go into PTSD with the same confidence we went into MDD with the dose that we selected initially for patients with primary GAD. And from a powering perspective, we continue to look at this like 5-point change on the scale as being a really good sweet spot for us to aim for.

因此，我們以同樣的信心進入 PTSD，就如同我們以最初為主要 GAD 患者所選定的劑量進入 MDD 一樣。從統計把握度（powering）的角度，我們仍然把量表上 5 分的變化視為一個非常理想、值得我們鎖定的甜蜜點。

We're continuing to think about that across the scale. So the scale is the HAM-A for GAD, the MADRS for MDD or the CAPS for PTSD.

我們也持續在各個量表上以這個方向思考。也就是說，GAD 用的是 HAM-A 量表，MDD 用的是 MADRS，PTSD 用的是 CAPS。

Francois Brisebois, LifeSci Capital.

Francois Brisebois，LifeSci Capital。

Hi, thanks for taking the question. So, you talk about the overlap here, and I just wanted maybe a better understanding of, it seems like MDD is more episodic, but with GAD, and just in terms of, probability of success or not of the trials, is there more confidence in one versus the other? And to that point, is it a thing about, is there anything about the disease itself with GAD that could trigger a higher placebo response, or is this more from the kind of trial design, we think, like you mentioned?

嗨，謝謝讓我提問。你們談到這裡的重疊性，我想更了解一下：看起來 MDD 比較是發作性的（episodic），而 GAD 則不同；就試驗成功機率而言，你們對其中一個是否比另一個更有信心？另外延伸來說，GAD 這個疾病本身是否有任何因素可能引發較高的安慰劑反應？還是說這更多是來自試驗設計本身（如你們提到的）？

Yeah, thanks so much, Frank. I'll turn that one back over to Dan as well.

好的，非常感謝你，Frank。這題我也再交回給 Dan。

Yeah, it's a great question, Frank. And we've said this in a few different ways. And obviously, we've introduced some new slides in the deck now to look at the GAD/MDD overlap. But as you noted, it really is in the vast majority of patients, something of a temporal distinction. These are folks who -- if they have MDD, it's because they have had or are currently in a major depressive episode, major depressive episodes by their definition end.

是的，Frank，這是個很好的問題。我們用幾種不同方式談過這件事。而且很明顯地，我們現在也在簡報中加入了一些新投影片來看 GAD/MDD 的重疊。但如你所說，對絕大多數患者而言，這確實主要是一種時間上的區別。這些人如果有 MDD，是因為他們曾經有或目前正處於重度憂鬱發作；而重度憂鬱發作依其定義是會結束的。

So they have start points and end points, whereas GAD, we really think of as that give digitive background state of anxiety. What we do know is that the longer that someone has high anxiety, the more likely they are to have a major depressive episode, and the more major depressive episodes and the more severe major depressive episodes people have, the more likely they are to have high levels of anxiety in the background.

所以它有起點也有終點；相較之下，GAD 我們更把它視為一種長期存在的背景性焦慮狀態。我們知道的是，一個人高焦慮持續越久，就越可能出現重度憂鬱發作；而一個人重度憂鬱發作越多、越嚴重，也越可能在背景中伴隨高程度的焦慮。

And so when we think about probability of success, it's really an interesting question. Historically, MDD has been an easier target for all classes of antidepressants than GAD with those same antidepressants. And in part, that's due to the fact that we're, in the case of MDD, helping folks go to a state that they were in.

因此，當我們思考成功機率時，這確實是個有趣的問題。從歷史上看，對於各類抗憂鬱藥而言，MDD 一直比使用同樣抗憂鬱藥治療 GAD 更容易達成目標。部分原因在於，在 MDD 的情況下，我們是在幫助患者回到他們曾經處於的狀態。

If not recently, at least fairly recently, in the last year or two years at the most, and often much more recently than that. So it's more like resetting a state that the person will get back to and has been in more recently, whereas GAD is more of a change to a state that someone probably hasn't been in in quite some time because of the longitudinal nature of the disease.

即使不是最近，至少也相對近期——最多在過去一到兩年內，而且往往比那更近。所以這更像是把狀態重置回患者較近期曾經達到過的狀態；而 GAD 則更像是把患者帶到一個他們可能已經很久沒有處於的狀態，因為這個疾病具有長期、縱向的特性。

So MDD has historically been an easier target, and that in part is what gives us great confidence. We also -- of course on Phase 2 that we were able to move the mattress pretty dramatically in the GAD patients we were treating, despite the fact that they were starting lower than we would ordinarily start people in an MDD study, which means, of course, there's less room on the scale to move it, and we still saw quite a bit of movement. So all of that together continues to give us real confidence in our MDD studies.

因此，MDD 歷來是較容易的目標，而這也部分是我們信心很高的原因。另外，當然，在第二期中，我們在所治療的 GAD 患者身上也能相當明顯地推動量表改善，儘管他們的起始分數比我們在 MDD 研究中通常納入的患者更低——這表示量表可改善的空間更小——但我們仍看到相當幅度的改善。綜合以上，持續讓我們對 MDD 研究非常有信心。

As for placebo and GAD, probably that's not what's at play here. I think that, as Rob spoke to already here and as we talk about kind of often, the design of that study both led to a higher actual placebo response with five arms or active and that the likelihood of getting drug being so high will drive an actual higher placebo response.

至於安慰劑反應與 GAD，我認為可能不是疾病本身在起作用。我想，正如 Rob 先前在這裡提到、以及我們也常談到的，該研究的設計——包含五個組別或多個活性組別——確實導致實際安慰劑反應較高；而獲得藥物的機率很高，也會推升實際安慰劑反應。

Particularly because there's these lower dose arms that may or may not feel like something to someone, so people on placebo could very easily mistakenly think they were on drug, but also with the dropout rate and the data replacement strategy, taking that already actual high placebo response and making the measured placebo response actually over-represent the background real placebo response. So that's probably more causal than the disease state itself.

特別是因為有這些較低劑量組，受試者可能會、也可能不會感覺到什麼，因此安慰劑組的人很容易誤以為自己拿到的是藥；此外，退出率以及資料替補策略，會把原本就偏高的實際安慰劑反應，進一步使量測到的安慰劑反應高估了背景的真實安慰劑反應。所以，這可能比疾病狀態本身更具因果性。

Maybe, thank you for that, and maybe if I could jump in quickly, Matt, you made a comment there that you guys have shared before, but can you just help us understand, we don't hear this much, 1% penetration of the TAM equals to about 2 billion, so can you help us understand how that TAM -- how do you handle the overlap of MDD and GAD to get to that number?

另外，謝謝你的說明；如果我可以快速插問一下，Matt，你剛才提到一點你們以前也分享過，但能否幫我們理解一下：TAM 的 1% 滲透率約等於 20 億美元；你能否說明這個 TAM 是怎麼算出來的——你們如何處理 MDD 與 GAD 的重疊，才得到那個數字？

And then on the commercial side too, can you just help us, remind us what the learnings are from the J-code implications for Spravato and how that might have triggered sales? Thank you.

另外在商業化方面，也請你們幫我們回顧一下：Spravato 的 J-code 所帶來的影響有哪些學習？以及它可能如何帶動銷售？謝謝。

Sure. So the 4.2 million patient number that I cite is, it includes any of those patients who have both. And so these are unique patients that we've identified. These are all patients 18 and over. So that is the truth, TAM, how we've taken into account any of the overlap. If they have a dual diagnosis, they are deduped.

當然。我引用的 420 萬名患者數，是包含同時具有兩者診斷的患者。而且這些是我們所識別出的不重複（unique）患者。這些都是 18 歲以上的患者。因此，這就是我們所定義的真實 TAM，以及我們如何把任何重疊納入考量。如果他們是雙重診斷，我們會去重（dedupe）。

In regard to the J-code for Spravato. I think what that does is it gives us good confidence that there's the path forward to submit for a J-code for DT120 as well. And so that's been in our plans, and that's an operating assumption to submit once we get in the market if DT120 is approved.

至於 Spravato 的 J-code。我認為這讓我們更有信心，DT120 未來也有路徑可以申請 J-code。因此這一直在我們的規劃之中，而且如果 DT120 獲批上市，我們的營運假設之一就是在上市後提交 J-code 申請。

Pete Stavropoulos, Cantor.

Pete Stavropoulos，Cantor。

Hi, this is Samantha on the line for Pete. Thanks for taking our questions and congrats on the quarter. For the MDD [OLE], you set the trigger for redosing at a MADRS score of 20 or greater. Could you help us understand why 20 was chosen? And through your market research, is that level of severity a threshold where healthcare practitioners would likely recommend the patients, another dosing session.

嗨，我是 Samantha，代表 Pete 在線上。謝謝讓我們提問，也恭喜本季表現。關於 MDD 的 [OLE]，你們把再次給藥（redosing）的觸發條件設定為 MADRS 分數達到 20 分或以上。能否幫我們理解為什麼選 20 分？另外，根據你們的市場調查，這樣的嚴重程度是否是一個臨床門檻，使醫療照護專業人員可能會建議患者再進行一次給藥療程？

Yeah, thanks so much. I'll turn it over to Dan as well.

是的，非常感謝。我也把時間交給 Dan。

Yeah, great question, Samantha. Across our studies, what we've decided to do in the Part Bs is set the threshold on the scale at the line between mild and moderate. And there are a couple of, obviously, on all these scales, that's somewhat arbitrary, right?

是的，Samantha，問得很好。在我們各項研究中，我們在 B 部分所做的決定，是把量表上的門檻設定在「輕度」與「中度」之間的分界線。當然，在所有這些量表上，這在某種程度上是有點任意的，對吧？

The scale designers pick numbers and those get psychometrically tested and validated and those numbers become the thresholds for the life of the scale at some level. But we thought the threshold between mild and moderate was particularly interesting because, yes, in talking to the wide community of prescribers and treaters out there, this certainly seems like the level at which people would consider even medication at all, let alone a more intensive and likely expensive medication.

量表設計者會選定一些數值，並透過心理計量學測試與驗證；在某個層面上，這些數值就成為該量表在其使用期間的門檻。但我們認為「輕度」與「中度」之間的門檻特別有意思，因為是的，與廣泛的處方醫師與治療者社群交流後，這確實看起來是人們會開始考慮用藥的程度，更不用說更密集、且很可能更昂貴的藥物。

That threshold also corresponds with an interesting change, which is a little less scale-based. But the practical reality is that when we think about mild versus moderate illness, moderate is where people start to accumulate functional deficits, where the symptoms of the disorder become severe enough that they interfere with activities of life, activities of daily living, whether they're school, work, family, whatever.

那個門檻也對應到一個有趣的變化，這就比較不是以量表為基礎。但實務上的現實是，當我們思考輕度與中度疾病時，中度是人們開始累積功能缺損的階段；也就是疾病症狀嚴重到會干擾生活活動、日常生活活動，不論是學校、工作、家庭或其他。

And so that seemed to us to be the reasonable place to draw the line in the studies and a likely threshold that would be applied clinically, though by no means would it be a necessary threshold for clinicians to follow because, of course, in the end of the day, clinical judgment rules everything. And these scales, because of their intensiveness of administration, are not often used in clinical practice.

因此，在研究中我們覺得把界線畫在那裡是合理的，也很可能是臨床上會採用的門檻；但這絕非臨床醫師必須遵循的必要門檻，因為當然，歸根究柢，臨床判斷凌駕一切。而且這些量表因為施測相當繁複，在臨床實務中並不常使用。

So what we assume will happen with real prescribers, based on the conversations we've had with those folks, is that if in their assessment they assess someone to have functional deficits from their disorder, that that will very much push them in the direction of using therapies like ours.

所以，根據我們與這些臨床人員的對話，我們假設實際的處方醫師會發生的情況是：如果他們在評估中判定某人因其疾病而出現功能缺損，這將大幅推動他們朝向使用像我們這樣的治療。

I'll add one bit of color there too, Sam, which is just that while there's a lot of discussion, of course, about the various subsets of MDD and the patient populations who have not previously responded to SRIs as being some sort of unique entity, the real thing we see both in terms of patient experience and in terms of health economic outcomes and all the things that actually drive benefit both personal and functionally and economically is improving the severity.

Sam，我也補充一點背景：雖然大家當然對 MDD 的各種子族群，以及先前對 SRI 沒有反應的病人族群是否屬於某種獨特實體，有很多討論；但我們真正看到的，無論是病人經驗、健康經濟結果，或所有實際驅動個人、功能與經濟層面效益的因素，都是「改善嚴重度」。

So finding patients who have severe symptoms and improving those down to a state where that functional deficit is improved meaningfully. And that's why we set the threshold for treatment there. It's also why we're so focused on looking at the severity of these populations rather than styling ourselves into a small subset of the population that just didn't respond to two pass SRIs.

也就是找出症狀嚴重的病人，並把嚴重度改善到功能缺損能夠有意義地改善的狀態。這就是我們把治療門檻設在那裡的原因。也因此我們非常專注於檢視這些族群的嚴重度，而不是把自己定位成只是一小群「對兩次 SRI 治療都沒有反應」的人。

Very clear. Thank you. And if I can just sneak in one more question. So with interventional psychiatry being increasingly integrated into practices and healthcare systems, what preparations are underway at clinics to pivot and deliver DT120 operationally? And maybe what are you hearing as you do your commercial prep work?

非常清楚。謝謝。如果我可以再偷偷問一個問題：隨著介入式精神醫學愈來愈多整合進診所與醫療體系，診所在營運上要轉向並提供 DT120，正在做哪些準備？以及在你們做商業化準備時，聽到的回饋是什麼？

Matt, I'll turn it over to you.

Matt，我把這題交給你。

Thanks, Sam, for the question. What we're hearing from clinicians, especially those that are doing high volumes of intervention today is that they have been prepping for the psychedelics coming to market and that they're allocating space for that.

謝謝你，Sam，這個問題。我們從臨床醫師那裡聽到的，特別是目前就已經在做大量介入治療的那些人，是他們一直在為迷幻藥物上市做準備，並且正在為此配置空間。

We feel pretty encouraged by the anticipation and the receptivity of the market for these interventions as they make their way into market. And certainly, there's a high anticipation for DT120, and some of the data that we shared just a couple of weeks ago, I think really highlights the momentum and the receptivity of the market.

對於這些介入治療逐步進入市場時，市場的期待與接受度，我們感到相當鼓舞。而且市場對 DT120 的期待確實很高；我們在幾週前分享的一些數據，我認為也很凸顯這股動能與市場的接受度。

So we're encouraged by all those different facets, and we believe that our targeting model really does help to prioritize those physicians who are, A, receptive to the drug concept; and B, have the capability and the capacity to accommodate these patients for treatment.

因此，從各個面向來看我們都受到鼓舞；我們也相信，我們的鎖定（targeting）模型確實有助於優先聚焦那些醫師：A，對藥物概念持開放態度；以及 B，具備能力與量能來接納這些病人進行治療。

Matthew Hershenhorn, Oppenheimer.

Matthew Hershenhorn，Oppenheimer。

Oh, hey, guys. Congrats on all the progress. Thanks for taking our questions, and thanks again for hosting us two weeks ago at your event. Very insightful and really appreciate it. The question we had was just as you talked to clinics, what are some of the economic incentives they have to modify capacity for DT120, especially considering away from Spravato?

喔，嗨，各位。恭喜你們取得所有進展。謝謝回答我們的問題，也再次感謝兩週前在你們的活動中接待我們。非常有洞見，我們真的很感激。我們的問題是：當你們與診所交流時，他們為了 DT120 調整產能，有哪些經濟誘因，特別是考量到要從 Spravato 轉移？

And if you see time-based reimbursement and less friction arising from patient turnover compared to Spravato as potential advantages, and perhaps. If you have any estimate on how many clinics it would take to eventually treat 100,000 patients per year, just considering likely capacity, we'd really appreciate it. Thank you.

以及你們是否認為，相較於 Spravato，以時間為基礎的給付（reimbursement）以及因病人周轉而產生的摩擦更少，可能是潛在優勢。另外，如果你們能估算一下，最終要每年治療 100,000 名病人，大概需要多少家診所（僅就可能的產能來看），我們會非常感謝。謝謝。

Yeah, thanks for the question. And regarding the practice economics, certainly, we recognize that that's top of mind for physicians, and we are in the process of building out clear direction on what will be available at launch and also those codes that we want to secure post-launch, make sure that physicians are adequately reimbursed for the administration.

是的，謝謝你的問題。關於診所端的經濟性，我們當然理解這是醫師最關心的議題之一；我們正在建立清楚的指引，說明上市時可提供哪些內容，以及我們希望在上市後取得的那些代碼（codes），以確保醫師在施作/給藥（administration）方面能獲得足夠的給付。

I think the way that the clinics have been thinking about this, at least early on, has been to allocate a certain amount of space, and then they will -- their anticipation is to judge the market and judge the volumes that are coming in, to determine whether they need to allocate additional space to their clinics.

我認為診所目前（至少在早期）對此的思考方式，是先配置一定的空間，然後他們預期會觀察市場、觀察進來的量，來決定是否需要在診所配置更多空間。

So this is something that's really going to be determined as we get into market. As we get closer, we'll have a lot more market research to share on what we think that volume and capacity will be both in market and downstream in years thereafter.

所以這件事真的會在我們進入市場後才會逐步明朗。隨著時間更接近，我們會分享更多市場研究，說明我們認為在市場中以及之後幾年下游（downstream）的量與產能會是什麼樣子。

Got it. Thank you so much. And one additional question quickly was just on PTSD. If you could please talk about any differentiated advantages for DT120 just compared to the other psychedelics, psilocybin and DMT, specifically for this indication, just thinking of the various symptoms there. And if you have any input or discussions with the VA, just considering the prevalence amongst veterans there, informing enrollment criteria or any data collection that they could potentially be interested in, would definitely appreciate it. Thanks again.

了解。非常感謝。另外我想快速再問一題關於 PTSD。能否請你談談 DT120 相較於其他迷幻藥物（裸蓋菇素 psilocybin 與 DMT），在這個適應症上有哪些差異化優勢？我主要是從各種症狀的角度來思考。以及如果你們與退伍軍人事務部（VA）有任何交流或討論，考量到退伍軍人族群的盛行率，是否有助於制定入組標準或任何他們可能感興趣的資料收集，我們也會非常感謝。再次謝謝。

Dan, you want to take that one?

Dan，你要回答這題嗎？

Yes, happy to. So one of the things that we hear from sites quite a bit about the characteristics of DT120 and the patient experience with DT120 is that it, it is very well tolerated, particularly emotionally, that people find the onset of the drug, its action while it's at its sort of plateau effect, and then the gentle return to a normal state of consciousness to be tolerated well and also to be pleasant in ways that other drugs may not be. And so particularly with folks with high levels of anxious arousal.

好的，很樂意。我們從試驗中心經常聽到關於 DT120 特性與病人使用 DT120 的體驗：它的耐受性非常好，特別是在情緒層面；人們覺得藥物的起效、在達到某種平台期（plateau effect）時的作用，以及溫和地回到正常意識狀態的過程，都很容易耐受，而且在某些方面也令人愉悅，這是其他藥物未必能做到的。因此，特別是對於焦慮喚起（anxious arousal）程度很高的人。

That's probably a good thing, right, that we want folks who are particularly attuned to their surroundings and attuned to that sort of hypervigilance that happens with PTSD to have that sort of experience, have a predictable and gentle experience that allows them both the time to have the experience that they're having while they're at the plateau, but also to have that predictable onset and offset. We think that really is a differentiated advantage of the drug itself.

這大概是件好事，對吧？我們希望那些對周遭環境特別敏感、也特別容易出現 PTSD 那種高度警覺（hypervigilance）的人，能有那樣的體驗——一種可預期且溫和的體驗，讓他們在平台期時有時間去經歷當下的體驗，同時也有可預期的起效與退效。我們認為這確實是藥物本身的一項差異化優勢。

Got it. Really helpful. Thank you guys again. Appreciate it.

了解了。真的很有幫助。再次謝謝各位。感激不盡。

What I didn't say was the second-half there about the VA and we've been working with VA researchers on our research to date. And of course, as we move into the world of PTSD, we will continue to deepen and strengthen those relationships. And of course, we're continually seeking advice from experts across the different conditions we work with, but the VA expertise in PTSD will be really important to the design and execution of those studies, as it has been in our studies to date.

我剛才沒提到的是後半段關於退伍軍人事務部（VA）的部分，而我們迄今為止的研究一直在與VA的研究人員合作。當然，隨著我們進入PTSD領域，我們會持續深化並強化這些合作關係。同時，我們也持續向我們所涉獵的不同適應症領域的專家徵詢建議；而VA在PTSD方面的專業，將對這些研究的設計與執行非常重要，就如同它在我們迄今的研究中所扮演的角色一樣。

Perfect. Thank you so much for addressing that. Thanks again, guys.

太好了。非常感謝你回應這點。再次謝謝各位。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

Good afternoon. Thanks for taking our questions. I have three. First, what are your latest thoughts on a filing strategy? Would you file both GAD and MDD at the same time? Or do you think GAD, which will have two Phase 3 readouts earlier, will be your first targeted indication? That's the first question.

下午好。謝謝你們回答我們的問題。我有三個問題。第一，你們對申報策略最新的想法是什麼？你們會同時就GAD與MDD一起申請嗎？還是你們認為GAD因為會更早有兩項三期讀出，會是你們第一個鎖定的適應症？這是第一個問題。

Obviously, we're having a lot of discussions at FDA and have been around that appropriate strategy. I think what we, of course, have seen also a lot coming out of FDA about thinking for filing on studies where there is a high degree of overlap, and there's still a long regulatory and legal precedent when there are highly overlapping indications for a single study to be supportive of expansion into that indication.

顯然，我們一直在與FDA進行大量討論，圍繞合適的策略。我想我們也看到FDA近期有不少訊息，談到在高度重疊的研究上如何思考申報；而且在法規與法律上也仍有長期先例：當單一研究所涵蓋的適應症高度重疊時，該研究可作為支持擴展至該適應症的依據。

I would say some of that's going to be contingent on how compelling data are across the studies and particularly in MDD, right? If we see a smaller effect, I think obviously we have less compelling evidence and if there's an extraordinarily large effect that we're observing that would imply quite small studies needed to replicate that.

我會說其中一部分將取決於各項研究的數據有多具說服力，特別是在MDD方面。如果我們看到較小的效果，顯然證據就沒那麼有力；而如果我們觀察到非常大的效果，則意味著需要用來重複驗證的研究規模可能相當小。

So something's going to be ultimately informed by the data and subsequent discussions with FDA, but we feel quite confident in the position for filing 120. And regardless of whether that's filed concurrently or sequentially, we think we'll be in a great position to go after both these markets, hopefully, as we get in the market and get into the patient population before she has to get the drug approved.

因此，最終會由數據以及後續與FDA的討論來決定，但我們對DT120的申報立場相當有信心。而不論是同步或依序申報，我們都認為自己將處於非常有利的位置去爭取這兩個市場；希望在產品上市、進入病患族群後，能在藥物獲批之前就做好準備。

And second, for Matt, on commercialization, both GAD and MDD present very large opportunities, but which one do you think could prove more challenging to crack for DT120 and why?

第二個問題給Matt，關於商業化：GAD與MDD都是非常大的機會，但你認為哪一個對DT120而言可能更難打入？原因是什麼？

Look, we feel like the unmet needs for both these indications are high, and there is great receptivity in our market research for both indications. And so our targeting model, our value proposition is really aimed at both indications. We don't have a favorite. We do believe that there are a lot of patients out there that need help and need this treatment.

你看，我們認為這兩個適應症的未被滿足需求都很高，而我們的市場研究也顯示兩者都有很高的接受度。因此，我們的目標客群模型與價值主張其實是同時針對這兩個適應症。我們沒有偏好哪一個。我們確實相信外面有很多病患需要幫助、需要這種治療。

And so if approved, we believe that we're going after both markets, should we have a dual indication, with equal measure. Keep in mind, too, that the diagnosis of GAD is not as reflective in the claims data as MDD, simply because there haven't been any novel treatments in a couple of decades.

所以如果獲批，我們相信在具備雙適應症的情況下，我們會同等力度地開拓兩個市場。另外也請記得，GAD的診斷在理賠（claims）資料中的反映程度不如MDD，原因很簡單：過去幾十年都沒有新的治療。

So we do believe that there's a lot of GAD out there that isn't adequately diagnosed in the ICD-10 data, but we believe that that will also change with therapeutic intervention that meets that need.

因此我們確實認為有大量GAD並未在ICD-10資料中被充分診斷出來，但我們也相信，隨著能滿足需求的治療介入出現，這種情況也會改變。

And last one is almost perhaps a philosophical question, what are the real-world advantages and disadvantages of receiving a Commissioner's National Priority Voucher?

最後一題幾乎算是哲學性問題：獲得Commissioner’s National Priority Voucher（局長國家優先審查憑證）的現實世界優點與缺點是什麼？

Yeah, thanks, Matt. It's a good question and one, I think, obviously, anything that we can do to accelerate and be more efficient in development, we certainly are interested in entertaining. That's why we've been going at really lightning speed and we hope this I&D less than about four years ago, so we've been going at an incredible pace of development, and those are the things that we can, of course, control and put in all the time and effort and do research the right way to move program forward to pivot data, which we have coming up very soon.

是的，謝謝你，Matt。這是個好問題。我想很明顯，任何能讓我們在開發上加速、提高效率的方式，我們都願意考慮。這也是為什麼我們一直以非常快的速度推進；我們在不到大約四年前才啟動這個I&D（研發）計畫，但開發進度非常驚人。這些都是我們能掌控的：投入時間與努力、以正確方式做研究，推動計畫前進，並取得我們很快就會公布的關鍵數據。

So what comes after that? And obviously, with novel programs with FDA, there certainly can be advantages. There's also potential risks. I think one thing that's particularly important for our program, too, is this opportunity to potentially go after both of these indications. And if we're in that position, there's a lot being navigated in terms of which both one or the other would potentially benefit from something like a CMPP.

那接下來是什麼？顯然，對於與FDA的創新機制，確實可能有優勢。同時也存在潛在風險。對我們的計畫而言，另一個特別重要的點是：我們有機會同時爭取這兩個適應症。如果我們處於那樣的位置，就需要在「兩者之中哪一個、或是否兩者都能」從像CMPP這樣的機制中受益方面，進行大量權衡與推進。

So. We've, of course, seen some positives come out of that. We've seen some risks associated with that. So we're going to keep with our great dialogue with FDA and continue to look for opportunities to accelerate anywhere we can. But right now, getting the data and going as efficiently from there towards an NDA application is where we're focused.

所以。我們當然看到其中一些正面成果。也看到一些相關風險。因此我們會持續與FDA保持良好對話，並持續尋找任何可加速的機會。但目前我們的重點是先拿到數據，並在此基礎上以最高效率推進到NDA申請。

Thank you.

謝謝。

Chris Chen, Baird.

Chris Chen，Baird。

Hey, everyone. Thanks for taking my question and congrats on the progress. Just regarding the Emerge readout, I'm just curious how granular your patient time to discharge data will be. And if you do go slightly over, that eight-hour window, is it still possible to still secure a label with an eight-hour treatment window? Thanks.

各位好。謝謝讓我提問，也恭喜進展順利。關於Emerge的讀出，我想了解你們的「病患從治療到出院」時間資料會細到什麼程度。如果稍微超過那個八小時的窗口，是否仍有可能拿到標示（label）上寫八小時治療窗口？謝謝。

Thanks, Chris. We are extremely detail-oriented in everything we do and try to get really precise definition of all of the important characteristics of these studies, and we'll do the same in terms of how we have been doing. Analyzing the endothelic checklist and when patients can be cleared for monitoring.

謝謝你，Chris。我們在所有事情上都非常注重細節，並努力對這些研究的重要特徵做出非常精確的定義；在這方面我們也會一樣，延續我們一直以來的做法。我們會分析endothelic檢核表，以及病患何時可以解除監測。

And of course, those dynamics, we'll be looking at everything from means to side effects to individual patients and anything that could be useful there. So it's going to be something that we're quite interested in and we feel quite excited about being able to present some data from.

當然，對於這些動態，我們會從平均值、副作用到個別病患等各個層面全面檢視，任何可能有用的資訊都會納入。所以這是我們非常感興趣的部分，也很期待能夠呈現一些相關數據。

Patrick Trucchio, HC.

Patrick Trucchio，HC。

Hi, it's Arabella under Patrick. Thank you so much for taking the question. I guess now that [DEA] rescheduling can be done after a successful Phase 3, how much time is that realistically actually going to save? And then I guess how are you thinking about initiating those conversations once you get the data?

嗨，我是Patrick名下的Arabella。非常感謝讓我提問。我想問，既然[DEA]重新分級可以在三期成功後進行，這在現實中到底能節省多少時間？另外，一旦你們拿到數據，你們會如何啟動這些對話？

And then I was also just wondering if you could comment on DT402 in ASD, and what kind of metrics or signals that you're looking for to move the program forward. Thank you.

另外我也想請你們評論一下DT402在ASD上的進展，以及你們在尋找哪些指標或訊號來推動這個計畫往前走。謝謝。

Yeah, thanks, Arbella. I think you're referring to the executive order that President Trump signed, indicating the DEA should look at scheduling their scheduling assessment after phase three data, not after FDA approval.

好的，謝謝你，Arbella。我想你指的是川普總統簽署的行政命令，內容指出DEA應在取得三期數據後、而不是在FDA核准後，進行其分級（scheduling）評估。

If that were to be implemented directly and DEA could, as a result, make a decision on scheduling at the same time of an NDA approval, that could save 90 days, which is the timeline right now, to get to an interim final rule and issuance of the schedule for the approved product. So there's a real opportunity and it's something we've been actually quite engaged with for a while, exploring opportunities to not shortcut anything, but to streamline the process and enhance the collaboration across agencies within the federal government to make that timeline from FDA approval to patients actually getting access to the drug as short as possible.

如果這項措施能直接落實，且DEA因此能在NDA核准的同時就對分級作出決定，那麼可節省90天；這是目前從取得臨時最終規則（interim final rule）到核發已核准產品分級所需的時間。因此確實存在機會。我們其實也已經投入一段時間在這方面，探索如何在不走捷徑的前提下，精簡流程並強化聯邦政府內跨機關合作，讓從FDA核准到病患真正取得藥物的時間盡可能縮短。

With such a huge need and such an opportunity to address that need, we shouldn't be waiting any days that we don't have to get these drugs to patients. So we're quite excited about that opportunity and to continue to have great dialogue with FDA, with CSS and FDA and whenever we were able with DEA. To your second question, I'll turn it over to Dan to briefly touch on 402.

鑑於如此龐大的需求以及滿足該需求的機會，我們不應該在任何不必要的日子裡等待，應盡快把這些藥物送到病患手中。因此，我們對這個機會感到非常振奮，並期待持續與 FDA、與 CSS 和 FDA 進行良好的對話，且在我們能夠的情況下也與 DEA 保持溝通。至於你的第二個問題，我把時間交給 Dan，請他簡要談一下 402。

Yeah, thanks for asking about 402. We'd love to get a chance to talk about it. So, as we've said before, we're doing a pretty interesting signal of efficacy study in ASD. And in order to do that across the course of a day, we've -- we combined a set of measures that we're able to do repeatedly through the day, right, to look at the dynamics of pre-dose, early in the dosing experience, and then late in the dosing experience and again as the drug wears off.

是的，謝謝你問到 402。我們很希望有機會談談它。所以，如同我們之前所說，我們正在 ASD 上做一項相當有意思的療效訊號研究。而為了在一天的過程中做到這點，我們——我們把一組可以在一天中反覆施測的量測指標結合起來，對吧，用來觀察給藥前、給藥體驗早期、以及給藥體驗後期的動態變化，並在藥效消退時再次評估。

And so to do that, we've constructed -- what might be a little bit skinnier instruments that you ordinarily use for regulatory approach, but that have the components of those -- the construct components of those instruments that can be asked reasonably quickly and repeatedly through the day. So, we've got patient-reported outcomes, we've got clinician observation outcomes, caregiver observation outcomes, and some digital markers, some sort of novel digital behavioral markers that look at things like voice and facial expression, and eye tracking, all rolled into what is a pretty dense day of dosing with as many different measures as we could comfortably for the patient experience that fit into that dosing day.

因此，為了做到這點，我們建構了——可能是比你在法規取向中通常使用的工具更「精簡」一些的量表，但它們保留了那些工具的——其建構（構念）要素，並且能夠在一天中以合理快速且可重複的方式提問與評估。所以，我們有病患自陳結果、有臨床醫師觀察結果、有照護者觀察結果，還有一些數位指標、一些新穎的數位行為標記，用來觀察例如聲音與臉部表情、以及眼動追蹤等，全部整合在一個相當密集的給藥日中；在不影響病患體驗舒適度的前提下，我們盡可能納入多種不同的量測，並讓它們適配於那一天的給藥流程。

Ami Fadia, Needham Company.

Ami Fadia，Needham 公司。

Hi, good afternoon. Thanks for taking my question. How much data do you need from the studies where you're examining how long it takes for patients to take that second or third or fourth dose before you submit for approval and to be able to inform the circumstances of retreatment in the label? And also, how much data do you think you need to have the conversations with payers around coverage and pricing?

嗨，午安。謝謝讓我提問。在你們研究病患需要多久才會接受第二次、第三次或第四次劑量的那些試驗中，你們需要累積多少資料才會提交核准申請，並能在標籤上說明再治療（retreatment）的情境？另外，你們認為需要多少資料，才能與付款方就給付範圍與定價進行討論？

And then a second question is just with regards to the capacity in the market with the number of clinics that are out there today in order to really achieve sort of the peak potential. But how much expansion do you think there needs to be in terms of the number of clinics that are equipped to treat the psychedelics in the US? And what's sort of the timeframe or what are some bottlenecks that you think exist in order to see that type of expansion?

第二個問題是關於市場端的產能：以目前市面上診所的數量來看，要真正達到所謂的峰值潛力，現有診所量能如何？你們認為在美國，具備治療迷幻藥物（psychedelics）能力的診所數量需要擴增多少？以及你們認為要看到這種擴張的時間框架是什麼，或有哪些瓶頸會影響這類擴張？

Yes, thanks so much, Ami. We're absolutely confident in our position as we approve top-line data and getting the data from Part A. It's worth just pointing out briefly that in precedent drug approvals, particularly with antidepressants, we're in a lot of precedence, most of those drugs are approved on acute studies with post-marketing commitments to conduct longer-term chronic studies. And so we are pushing the bounds of what an acute study can do in this way. A single dose we're following patients for 12 weeks and GAD a primary endpoint at that 12 weeks, which is patients with GAD do not spontaneously have 12 weeks of significant improvement.

是的，非常感謝你，Ami。我們對自身立場非常有信心，因為我們即將公布主要（top-line）數據，並取得 A 部分（Part A）的資料。值得簡要指出的是，在既有藥物核准的先例中，特別是抗憂鬱藥，有很多先例顯示，多數藥物是基於急性期研究獲准，並在上市後承諾（post-marketing commitments）進行較長期的慢性期研究。因此，我們正以這種方式推進急性期研究所能達到的界限。單次給藥後我們追蹤病患 12 週，且在第 12 週以 GAD 作為主要終點；而 GAD 病患並不會自發性地在 12 週內出現顯著改善。

So that approach is one of the important components of what drives our confidence in being in a great position with the Part A data. Of course, the Part B data will be useful to inform intervals for retreatment and sort of overtime retreatment patterns, what happens upon subsequent retreatment, all the things we're trying to characterize there.

因此，這種做法是驅動我們對 A 部分資料處於非常有利位置之信心的重要組成之一。當然，B 部分（Part B）資料將有助於釐清再治療的間隔，以及隨時間推移的再治療模式、後續再次再治療時會發生什麼，以及我們試圖在那裡刻畫的所有事項。

But we already have quite a bit of that Part B data, and we'll continue to aggregate that across all of our programs throughout the remainder of this year and as we continue to progress towards the final.

不過我們已經擁有相當多的 B 部分資料，並且在今年剩餘時間以及我們持續推進至最終階段的過程中，會在所有專案中持續彙整這些資料。

In terms of capacity, we think that this is something that is significantly underappreciated by a lot of folks, which is that the capacity that exists today is really.

就產能而言，我們認為很多人嚴重低估了一點：也就是目前存在的產能其實非常——

Far in excess, I think, with any of the models that are out there project for adoption. So we do not see a sort of capacity constraint. One of the things we, for those of you who were in attendance in New York a few weeks ago with us, is try to bring a little bit of clarity and demystify what it actually means to set up a treatment room. If you have a room and a site is willing to spend a few hundred dollars on making it a little bit more comfortable, that might be better for patients.

我認為，遠遠超過任何現有模型對採用率所做的預測。因此，我們不認為會有產能限制。對於幾週前在紐約參與我們活動的各位，我們當時嘗試帶來一些更清楚的說明，並去除「建立治療室」實際上意味著什麼的神秘感。如果你有一個房間，而某個據點願意花幾百美元把它弄得更舒適一些，這對病患可能更好。

But, if you have a room that someone can be for an extended period of time in a current treatment facility, that's enough. And so we do not see that there being a substantial financial or logistical bottleneck. People use the term infrastructure, but that's far too heavy-handed of a word.

但如果你有一個房間，能讓某個人於現有治療機構中長時間待著，那就足夠了。因此，我們不認為會存在重大的財務或物流瓶頸。人們會用「基礎設施」這個詞，但那個詞用得太過沉重了。

So we think there's plenty of capacity today. There will, we expect, be a lot more capacity growth over time, and with what we intend to do, which is provide the best support to patients and providers out in the field so that they can adopt and get treatment if they so desire. And we think there'll be a great incentive and a great desire to adopt both treatment centers and for patients to come in for treatment.

所以我們認為目前的產能已經很充足。我們預期隨著時間推移，產能還會大幅成長；而我們打算做的是，為第一線的病患與醫療提供者提供最佳支援，讓他們在有意願時能夠採用並獲得治療。我們也認為，無論是治療中心採用，或病患前來接受治療，都會有很強的誘因與意願。

Thank you. This concludes the question-and-answer session. I'll now turn it back to CEO Rob Barrow for closing remarks.

謝謝。問答環節到此結束。我現在把時間交回給執行長 Rob Barrow 作結語。

All right. Well, thank you everyone for joining us today. We're very excited about the quarters ahead with three pivotal readouts anticipated across the second and third quarter, and we'll look forward to sharing those data in due course. Thank you all.

好的。那麼，謝謝各位今天加入我們。我們對接下來幾個季度感到非常振奮，因為預計在第二與第三季會有三項關鍵性（pivotal）結果讀出，我們也期待在適當時機與各位分享這些數據。謝謝大家。

Thank you for your participation in today's conference. This is the (inaudible) program. You may now disconnect.

感謝各位參與今天的會議。這是（聽不清）節目。您現在可以斷線。