Mind Medicine (MindMed) Inc (MNMD) 2025 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the MindMed third-quarter earnings conference call and webcast. (Operator Instructions) Please be advised that this conference is being recorded. I would now like to hand the conference over to our first speaker today, Gitan Jain, Head of IR. Please go ahead.

您好，感謝您的耐心等待。歡迎參加 MindMed 第三季財報電話會議和網路直播。（操作員說明）請注意，本次會議正在錄音。現在我謹將會議交給今天的第一位發言人，IR主管吉坦·賈恩。請繼續。

Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of MindMed's third-quarter 2025 business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer. Dr. Dan Karlin, our Chief Medical Officer; and Brandi Roberts, our Chief Financial Officer, are also on the call.

謝謝接線員，大家下午好。感謝您今天與我們一起探討 MindMed 2025 年第三季的業務亮點和財務表現。今天主持電話會議的將是我們的執行長羅伯·巴羅。我們的首席醫療官丹·卡林博士和首席財務官布蘭迪·羅伯茨也參加了電話會議。

An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we'll 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 runway 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 applicable Canadian securities regulators, including our annual report on Form 10-K and our Form 10-Q filed today. Forward-looking statements are based on the 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 applicable Canadian securities regulators or other significant events occurring outside of MindMed's normal course of business.

本次電話會議的錄音和網路直播回放也將在線上提供，詳情請參閱本次電話會議的新聞稿。在今天的電話會議中，我們將做出一些前瞻性聲明，包括但不限於關於我們候選產品的潛在安全性、有效性、監管和臨床進展、我們預期的現金流以及我們未來的預期、計劃、合作關係和前景的聲明。這些聲明會受到各種風險的影響，例如市場狀況的變化以及研發和監管審批過程中遇到的困難。這些以及其他風險因素已在提交給美國證券交易委員會和適用的加拿大證券監管機構的文件中進行了描述，包括我們今天提交的 10-K 表格年度報告和 10-Q 表格。前瞻性聲明是基於管理層在聲明發布之日的假設、意見和估計，包括向美國證券交易委員會和適用的加拿大證券監管機構提交的文件中描述的風險和不確定性不會發生，或者MindMed正常業務範圍之外發生的其他重大事件不會發生。

You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, November 6, 2025. MindMed disclaims any obligation to update such statements even if management's views change, except as required by law.

請注意，不要過度依賴這些前瞻性聲明，這些聲明截至今天（2025 年 11 月 6 日）已作出。除法律另有規定外，即使管理階層的觀點發生變化，MindMed 也不承擔更新此類聲明的義務。

With that, let me turn the call over to Rob.

那麼，我把電話交給羅佈吧。

Thank you, Gita, and thank you, everyone, for joining our call today. We delivered another solid quarter, advancing our clinical programs and continuing to build one of the most robust late-stage pipelines in our field. In addition, this quarter saw the publication of our full Phase IIb clinical trial results in the Journal of the American Medical Association, highlighting the rigor and impact of the clinical results we have generated to date.

謝謝吉塔，也謝謝大家今天參加我們的電話會議。我們又取得了穩健的季度業績，推進了臨床項目，並繼續建立了我們領域內最強大的後期研發管線之一。此外，本季我們在《美國醫學會雜誌》上發表了完整的 IIb 期臨床試驗結果，突顯了我們迄今為止所取得的臨床結果的嚴謹性和影響力。

Building on this scientific momentum, we successfully completed an underwritten public offering last week, raising approximately $259 million in gross proceeds. This additional capital further strengthens our balance sheet and enables us to strategically accelerate the development of MM120 and MM402.

憑藉這一科學發展勢頭，我們上週成功完成了承銷公開發行，籌集了約 2.59 億美元的總收益。這筆額外的資金進一步增強了我們的資產負債表，使我們能夠從策略上加快 MM120 和 MM402 的開發。

We continue to expand and strengthen our investor base, welcoming in new high-quality health care dedicated funds and mutual funds while deepening support from our long-term shareholders. This financing underscores the strength of our science and positions us for a transformational 2026, a pivotal year ahead with three top-line Phase III data readouts expected between our generalized anxiety disorder, or GAD, and major depressive disorder or MDD programs. Enrollment is strong and steady across our ongoing pivotal studies of MM120. We reiterate our guidance and continue to expect top-line results from Voyage in the first half of 2026 and Panorama in the second half of 2026. Due to faster-than-anticipated enrollment in the past quarter, top-line results from the Emerge study are now anticipated in mid-2026, an update from our prior guidance of second half of 2026.

我們不斷擴大和加強投資者基礎，歡迎新的高品質醫療保健專款和共同基金加入，同時加深長期股東的支持。這項融資凸顯了我們科學的實力，並使我們為具有變革意義的 2026 年做好準備。 2026 年是關鍵的一年，我們預計將在廣泛性焦慮症 (GAD) 和重度憂鬱症 (MDD) 項目之間公佈三個主要 III 期數據。我們正在進行的 MM120 關鍵性研究的入組情況強勁且穩定。我們重申我們的預期，並繼續預計 Voyage 將在 2026 年上半年實現營收成長，Panorama 將在 2026 年下半年實現營收成長。由於上一季入組速度超出預期，Emerge 研究的主要結果預計將於 2026 年年中公佈，這比我們先前預測的 2026 年下半年有所更新。

We are also excited to share further details of Ascend, our second Phase III study of MM120 in MDD, which we expect to initiate in mid-2026. We continue to deploy resources and operationalize our programs with remarkable efficiency in pursuit of approvals in both GAD and MDD, 2 of the most prevalent and burdensome psychiatric disorders.

我們也很高興與大家分享 Ascend 的更多細節，這是我們針對 MDD 的 MM120 的第二項 III 期研究，預計將於 2026 年年中啟動。我們持續投入資源，有效率地進行各項計劃，以期在 GAD 和 MDD 這兩種最普遍、最令人痛苦的精神疾病中獲得批准。

Over the course of 2025, we have continued our constructive dialogue with FDA and believe we are well positioned to deliver on an expeditious path forward in both indications. For far too long, patients struggling with anxiety and depression have been significantly underserved by current treatments. Many cycle through multiple therapies with limited success. They're looking for something different, a safe and effective new treatment option that they feel confident will deliver meaningful change, not just symptom suppression. Based on the safety, efficacy and durability we have demonstrated with MM120 ODT to date, we believe it has the potential to represent such a transformative option, addressing anxiety and depression through an efficient patient-centered delivery model.

在 2025 年，我們繼續與 FDA 進行建設性對話，並相信我們已做好充分準備，在兩種適應症方面迅速取得進展。長期以來，焦慮症和憂鬱症患者一直未能得到現有治療的充分重視。許多患者嘗試多種療法，但效果有限。他們正在尋找一些不同的方法，一種安全有效的新治療方案，他們相信這種方案可以帶來有意義的改變，而不僅僅是抑制症狀。根據我們迄今為止對 MM120 ODT 所證明的安全性、有效性和持久性，我們相信它有可能成為一種變革性的選擇，透過以患者為中心的有效給藥模式來解決焦慮和憂鬱問題。

It's also important to remember that the results we have generated to date have been achieved with a single dose administered as a monotherapy without co-administered psychotherapy. We believe that MM120 ODT could integrate well into the existing health care infrastructure using well-established reimbursement codes covering evaluation, prescribing and monitoring in addition to the actual treatment itself. Our goal is to reduce administrative barriers to adoption and help ensure that providers are appropriately compensated for their time and services. With regard to our additional R&D activities, we are pleased to share an important update on our second asset in the pipeline, MM402 or the R-enantiomer of MDMA. Having already completed a single ascending dose Phase I study of MM402 in healthy adult volunteers, we plan to initiate a Phase IIa study in participants with autism spectrum disorder, or ASD, by the end of 2025.

同樣重要的是要記住，我們迄今為止的成果都是透過單劑量單一療法實現的，沒有同時進行心理治療。我們相信，MM120 ODT 可以很好地融入現有的醫療保健基礎設施，利用完善的報銷代碼，涵蓋評估、處方和監測以及實際治療本身。我們的目標是減少採用過程中的行政障礙，並幫助確保提供者獲得與其時間和服務相符的適當報酬。關於我們的其他研發活動，我們很高興分享我們第二個在研資產 MM402（MDMA 的 R-對映體）的重要進展。MM402 已在健康成年志願者中完成了單次遞增劑量 I 期研究，我們計劃在 2025 年底前啟動針對自閉症譜系障礙 (ASD) 患者的 IIa 期研究。

We believe ASD represents another significant opportunity with growing prevalence and substantial unmet need. As we approach the last few months of 2025, our team remains laser-focused on executing our ongoing studies and laying the groundwork for a transformational 2026 and beyond.

我們認為，隨著自閉症譜系障礙盛行率的不斷上升和大量未滿足的需求，它代表著另一個重要的機會。隨著 2025 年最後幾個月的臨近，我們的團隊仍然全神貫注於執行我們正在進行的研究，並為具有變革意義的 2026 年及以後奠定基礎。

Looking ahead, we anticipate three pivotal data readouts of MM120 ODT for GAD and MDD in 2026, the initiation of our second pivotal study in MDD in 2026, the advancement of MM402 in ASD into a Phase II study by the end of 2025 and further advancement of our go-to-market strategy as we prepare for the potential launch of MM120 ODT. With strong momentum across all fronts, we're working hard to bring transformative treatment options to the many patients needing new alternatives.

展望未來，我們預計 MM120 ODT 在 2026 年將公佈其治療 GAD 和 MDD 的三項關鍵數據，啟動針對 MDD 的第二項關鍵研究，並在 2025 年底前將 MM402 治療 ASD 的研究推進到 II 期，同時進一步推進我們的市場推廣策略，為 MM120 ODT 的潛在上市做好準備。憑藉著各方面的強勁勢頭，我們正努力為許多需要新療法的患​​者帶來變革性的治療方案。

With that, I'll turn the call over to Dan for an update on our clinical programs.

接下來，我將把電話交給丹，讓他報告我們臨床計畫的最新進展。

Thanks, Rob. We continue to be highly encouraged by the enrollment trends we are seeing across our pivotal Phase III studies. As Rob mentioned earlier, in GAD, we expect to report Voyage results in the first half of 2026 and Panorama results in the second half of 2026. Given the especially strong enrollment in our ongoing MDD study, Emerge, we are excited to now be in a position to report results from Emerge in mid-2026. This quarter, we also saw the publication of our full Phase IIb trial results in the Journal of the American Medical Association, or JAMA.

謝謝你，羅伯。我們對各項關鍵性 III 期研究的入組趨勢持續感到非常鼓舞。正如羅布之前提到的，在 GAD，我們預計將在 2026 年上半年公佈 Voyage 的結果，並在 2026 年下半年公佈 Panorama 的結果。鑑於我們正在進行的 MDD 研究 Emerge 的參與人數特別多，我們很高興能夠在 2026 年年中公佈 Emerge 的研究結果。本季度，我們也在《美國醫學會雜誌》（JAMA）上發表了完整的 IIb 期試驗結果。

It's a big moment, not just for us, but for the entire field of psychiatry. This study represents the most robust randomized, placebo-controlled trial of Lysergic D-tartrate or LSD in a psychiatric population using today's modern scientific standards. This trial evaluated a single treatment across four dose levels, 25, 50, 100 and 200 micrograms and demonstrated compelling clinical activity with a statistically significant dose response. Our optimal 100-microgram dose showed both rapid and durable effects with a statistically significant 7.7-point greater reduction in HAM-A versus placebo at week 12. Additionally, 65% of patients in the 100-microgram cohort showed clinical response and 48% achieved remission 12 weeks after the single administration of MM120.

這不僅對我們來說是一個重要的時刻，對整個精神病學領域也是如此。這項研究是迄今為止最嚴謹的隨機、安慰劑對照試驗，研究了在精神病患者中使用麥角酸二氫吡啶（LSD）的效果，並採用了當今的現代科學標準。該試驗評估了四種劑量水平（25、50、100 和 200 微克）的單一療法，並證明了其具有顯著的臨床活性和統計學意義的劑量反應。我們的最佳劑量 100 微克顯示出快速且持久的效果，在第 12 週時，HAM-A 評分比安慰劑組顯著降低了 7.7 分。此外，100 微克組中有 65% 的患者在單次服用 MM120 12 週後出現臨床反應，48% 的患者達到緩解。

Moving to our Phase III program. Our GAD studies each have two parts: Part A, a 12-week randomized, double-blind, placebo-controlled assessment of MM120 ODT versus placebo; and Part B, a 40-week extension phase with open-label treatment opportunities to evaluate long-term durability and response patterns. In Voyage, we are targeting enrollment of approximately 200 participants who are being randomized 1:1 to MM120 ODT 100 micrograms or placebo, while in Panorama, we are targeting enrollment of 250 participants who are being randomized 2:1:2 to MM120 ODT 100 micrograms, 50 micrograms or placebo. These Phase III studies are modeled after our successful Phase IIb study using the Hamilton Anxiety Scale, or HAM-A, as the primary outcome measure. This was the outcome measure used for the approval of existing GAD therapies.

進入第三階段項目。我們的 GAD 研究均分為兩部分：A 部分為 12 週的隨機、雙盲、安慰劑對照評估，比較 MM120 ODT 與安慰劑的效果；B 部分為 40 週的擴展階段，提供開放標籤治療機會，以評估長期持久性和反應模式。在 Voyage 研究中，我們計劃招募約 200 名參與者，並將他們以 1:1 的比例隨機分配至 MM120 ODT 100 微克組或安慰劑組；而在 Panorama 研究中，我們計劃招募 250 名參與者，並將他們按 2:1:2 的比例隨機分配至安慰劑微克組 100 微克組。這些 III 期研究以我們成功的 IIb 期研究為藍本，採用漢密爾頓焦慮量表 (HAM-A) 作為主要結果指標。這是用於批准現有 GAD 療法的結果指標。

The primary endpoint in our Phase III studies is the HAM-A change from baseline to week 12. Building on the success of our Phase IIb results, even though we observed a 7.7 point placebo-adjusted improvement in Phase IIb, we've designed our Phase III trials to have 90% power to detect a 5-point improvement over placebo. We've also designed our Phase III trials to address functional unblinding, a topic that is often raised when discussing research methods being used to investigate drugs in the broad psychedelic category.

我們 III 期研究的主要終點是 HAM-A 評分從基線到第 12 週的變化。基於我們 IIb 期試驗的成功結果，儘管我們在 IIb 期試驗中觀察到安慰劑調整後的改善為 7.7 分，但我們設計的 III 期試驗具有 90% 的統計功效，可以檢測到比安慰劑改善 5 分。我們也設計了 III 期試驗來解決功能性揭盲問題，這是一個在討論用於研究廣泛迷幻藥類別藥物的研究方法時經常被提及的話題。

Clearly, MM120 ODT and other drugs in the category have a distinctive set of perceptual, cognitive and emotional effects at the time of administration. While the phenomenological nature of these effects is unique to the category, the vast majority of approved psychiatric drugs also have acute effects that result in participant unblinding. Even so, in order to maximize the integrity, reliability, interpretability and generalizability of our research, we have implemented a set of interventions intended to address this and other methodological considerations across our Phase IIb and Phase III programs.

顯然，MM120 ODT 和該類別的其他藥物在給藥時具有獨特的感知、認知和情緒效應。雖然這些效應的現象學性質是該類別所獨有的，但絕大多數獲準的精神藥物也具有導致參與者揭盲的急性效應。即便如此，為了最大限度地提高我們研究的完整性、可靠性、可解釋性和普遍性，我們實施了一系列幹預措施，旨在解決我們 IIb 期和 III 期計畫中的這個問題和其他方法論問題。

These include using central raters who are blinded to both treatment assignment and visit number, incorporating questionnaires to assess potential expectancy bias and unblinding, and in multiple of our studies, including additional control arms that are substantially perceivable by participants but are not of interest in assessments of clinical efficacy. Our continued interactions with FDA further support alignment with the rigor and design of our approach, reinforcing our belief that our development strategy can deliver definitive, clear and compelling evidence of the safety and efficacy of MM120 ODT in GAD and MDD.

這些措施包括使用對治療分配和訪視次數均不知情的中心評分員，納入問卷以評估潛在的期望偏差和揭盲，以及在我們的多項研究中，包括參與者可以明顯感知但與臨床療效評估無關的其他對照組。我們與 FDA 的持續互動進一步支持了我們方法的嚴謹性和設計上的一致性，強化了我們的信念，即我們的開發策略可以提供確鑿、清晰和令人信服的證據，證明 MM120 ODT 在 GAD 和 MDD 中的安全性和有效性。

Turning to our MDD program. We are pursuing a similar approach to our GAD program, which includes two pivotal studies following the same 2-part design. Both of our pivotal MDD studies, Emerge and Ascend are comprised of two parts: Part A, a 12-week randomized, double-blind, placebo-controlled parallel group period assessing the efficacy and safety of a single dose of MM120 ODT versus placebo; and Part B, a 40-week extension period with opportunities for open-label treatment. The primary endpoint in each study is change from baseline in the Montgomery-Asberg Depression Rating Scale or MADRS, at week 6 between MM120 ODT 100 micrograms and placebo. In Emerge, we are targeting enrollment of at least 140 participants randomized 1:1 to MM120 ODT 100 micrograms or placebo.

接下來，我們將介紹我們的MDD專案。我們正在對 GAD 計畫採取類似的方法，其中包括兩項關鍵研究，這兩項研究都遵循相同的兩部分設計。我們的兩項關鍵性 MDD 研究 Emerge 和 Ascend 均由兩部分組成：A 部分為 12 週的隨機、雙盲、安慰劑對照平行組試驗期，評估單劑量 MM120 ODT 與安慰劑相比的療效和安全性；B 部分為 40 週的擴展期，提供開放標籤治療的機會。每項研究的主要終點是第 6 週時 MM120 ODT 100 微克與安慰劑相比，蒙哥馬利-奧斯伯格憂鬱評定量表 (MADRS) 的基線變化。在 Emerge 研究中，我們的目標是招募至少 140 名參與者，以 1:1 的比例隨機分配至 MM120 ODT 100 微克組或安慰劑組。

We now anticipate top-line data from Emerge in mid-2026.

我們現在預計將在 2026 年年中獲得 Emerge 的總體數據。

In our second pivotal MDD study, Ascend, we are targeting enrollment of at least 175 participants randomized 2:1:2 to receive MM120, 100 micrograms, 50 micrograms or placebo. We expect to initiate Ascend in mid-2026. Moving to our next pipeline candidate. We are excited to share our plans to advance MM402, the R-enantiomer of MDMA. In preclinical studies, MM402 has shown promising prosocial effects with a potentially superior tolerability profile compared to both racemic MDMA and the S-enantiomer of MDMA.

在我們的第二項關鍵性 MDD 研究 Ascend 中，我們的目標是招募至少 175 名參與者，以 2:1:2 的比例隨機分配接受 MM120、100 微克、50 微克或安慰劑。我們預計將於 2026 年中啟動 Ascend 計畫。接下來介紹我們的下一位候選候選人。我們很高興與大家分享我們推進 MM402（MDMA 的 R-對映體）的計劃。在臨床前研究中，MM402 顯示出有希望的親社會效應，並且與外消旋 MDMA 和 MDMA 的 S-對映體相比，具有潛在的更優耐受性。

We're developing MM402 to target the core symptoms of autism spectrum disorder, specifically addressing social communication challenges. We believe this program represents another significant treatment opportunity given the high unmet need, the increasing prevalence of ASD and no FDA-approved therapies that specifically address these core symptoms. Having completed a Phase I single-ascending dose study that characterized the tolerability, pharmacokinetics and pharmacodynamics of MM402 in healthy adult volunteers, we plan to initiate a Phase IIa study later this year. This study will be a single-dose open-label design, assessing early signals of efficacy in up to 20 adult participants with ASD. The objectives and endpoints of the study are designed to characterize the pharmacodynamics and clinical effects of MM402 in adults with ASD across multiple functional domains.

我們正在發展 MM402，旨在解決自閉症譜系障礙的核心症狀，特別是社交溝通上的挑戰。我們認為，鑑於目前存在大量未滿足的需求、自閉症譜系障礙 (ASD) 的盛行率不斷上升，以及沒有 FDA 批准的專門針對這些核心症狀的療法，該計劃代表著另一個重要的治療機會。我們已完成一項 I 期單次遞增劑量研究，該研究描述了 MM402 在健康成年志願者中的耐受性、藥物動力學和藥效學，我們計劃於今年晚些時候啟動一項 IIa 期研究。這項研究將採用單劑量開放標籤設計，評估多達 20 名患有 ASD 的成年參與者的早期療效訊號。研究的目標和終點旨在描述 MM402 在 ASD 成人患者中跨多個功能領域的藥效學和臨床效果。

In summary, we are efficiently executing across our pipeline. Our pivotal Phase III programs for MM120 ODT in GAD and MDD remain on track for data readouts next year, and we plan to initiate Ascend, our second Phase III MDD trial in mid-2026. As we progress MM120 ODT towards commercialization, we are also excited to advance our MM402 program for ASD, furthering our mission to develop breakthrough treatments for underserved patients. With that, I'll turn the call over to Brandi to discuss our third-quarter financial results. Brandi?

總而言之，我們的整個流程都在有效率地執行。我們針對 GAD 和 MDD 的 MM120 ODT 的關鍵性 III 期項目仍按計劃進行，將於明年公佈數據，我們計劃於 2026 年年中啟動我們的第二個 MDD III 期試驗 Ascend。隨著 MM120 ODT 向商業化邁進，我們也很高興能推進針對 ASD 的 MM402 項目，進一步履行我們為服務不足的患者開發突破性療法的使命。接下來，我將把電話交給布蘭迪，讓她來討論我們第三季的財務表現。布蘭迪？

Thanks, Dan. Turning to our financial results for the quarter ended September 30, 2025, we ended the quarter with cash, cash equivalents and investments totaling $209.1 million. As Rob noted earlier, we successfully completed an underwritten public offering last week, raising $258.9 million in gross proceeds.

謝謝你，丹。回顧截至 2025 年 9 月 30 日的季度財務業績，我們季度末的現金、現金等價物和投資總額為 2.091 億美元。正如羅布之前提到的，我們上週成功完成了承銷公開發行，籌集了 2.589 億美元的總收益。

After deducting underwriter commissions and expenses, net proceeds are $242.8 million. We're very pleased with the outcome of our recent financing, which puts us in an excellent position for the future. We were encouraged by the strong level of high-quality investor interest in MindMed and in our development programs, a clear reflection of the confidence the investment community has in our mission. This funding allows us to accelerate key initiatives that will set MM120 up for success, including NDA preparation, state prioritization efforts for scheduling, market research and KOL education, among others. These efforts position us well to move quickly in the years ahead, pursuing submission of an NDA for MM120 ODT as soon as possible, and if approved, executing a robust and well-prepared commercial launch.

扣除承銷商佣金和費用後，淨收益為 2.428 億美元。我們對近期融資的結果非常滿意，這使我們在未來處於非常有利的地位。令我們倍感鼓舞的是，眾多高品質投資者對 MindMed 及其發展計畫表現出濃厚的興趣，這清楚地反映了投資界對我們使命的信心。這項資金使我們能夠加快關鍵措施的實施，為 MM120 的成功奠定基礎，包括 NDA 準備、各州優先安排課程、市場調查和 KOL 教育等。這些努力使我們能夠在未來幾年迅速行動，盡快提交 MM120 ODT 的新藥申請，如果獲得批准，我們將執行強有力的、準備充分的商業發布。

Based on the company's current operating plan and anticipated R&D milestones, the company believes that its cash, cash equivalents and investments as of September 30, 2025, along with the net proceeds from their recent offering, are sufficient to fund the company's operations into 2028. Expenses for the third quarter of 2025 were in line with our internal expectations as we continue to make significant progress with MM120 and MM402. R&D expenses were $31 million for the third quarter of 2025 compared to $17.2 million for the third quarter of 2024, an increase of $13.8 million. The overall increase was primarily due to increases of $11.7 million in MM120 program expenses, $2.5 million in internal personnel costs, reflecting expanded research and development capabilities and $200,000 in preclinical and other program expenses. These amounts were partially offset by a $600,000 reduction in MM402 program expenses.

根據該公司目前的營運計畫和預期的研發里程碑，本公司認為截至 2025 年 9 月 30 日的現金、現金等價物和投資，加上最近發行所得的淨收益，足以支持公司營運至 2028 年。2025 年第三季的支出符合我們的內部預期，因為我們在 MM120 和 MM402 方面繼續取得重大進展。2025 年第三季的研發費用為 3,100 萬美元，而 2024 年第三季為 1,720 萬美元，增加了 1,380 萬美元。整體成長主要歸因於 MM120 項目支出增加 1,170 萬美元，內部人員成本增加 250 萬美元（反映出研發能力的擴大），以及臨床前和其他項目支出增加 20 萬美元。這些金額部分被 MM402 項目支出減少 60 萬美元所抵銷。

G&A expenses were $14.7 million for the third quarter of 2025 compared to $7.6 million for the third quarter of 2024, an increase of $7.1 million. The increase was primarily due to increases of $3 million in personnel-related expenses, $2 million in commercial preparedness related expenses, $1.6 million in corporate affairs expenses and $500,000 in other miscellaneous administrative expenses. Net loss for the third quarter of 2025 was $67.3 million compared to $13.7 million for the same period in 2024. Note that our net loss can be impacted dramatically by the changes in the fair value of our 2022 USD financing warrants from quarter to quarter as our stock price fluctuates. The change in fair value for the third quarter was $22.5 million as our stock price increased from $6.49 at June 30, 2025, to $11.79 at September 30, 2025.

2025 年第三季一般及行政費用為 1,470 萬美元，而 2024 年第三季為 760 萬美元，增加了 710 萬美元。成長的主要原因是人員相關費用增加 300 萬美元，商業準備相關費用增加 200 萬美元，公司事務費用增加 160 萬美元，以及其他雜項行政費用增加 50 萬美元。2025 年第三季淨虧損為 6,730 萬美元，而 2024 年同期淨虧損為 1,370 萬美元。請注意，由於我們的股價波動，我們 2022 年美元融資認股權證的公允價值會隨季度變化而發生巨大變化，從而可能對我們的淨虧損產生重大影響。第三季公允價值變動為 2,250 萬美元，因為我們的股價從 2025 年 6 月 30 日的 6.49 美元上漲到 2025 年 9 月 30 日的 11.79 美元。

I'll also note that warrant exercises related to the 2022 financing have brought in approximately $2.5 million of cash this year with an additional $17.6 million of potential funding remaining prior to the warrant expirations in 2027. With that, I'll now turn it back over to Rob for closing remarks.

我還要指出，與 2022 年融資相關的認股權證行使今年已帶來約 250 萬美元的現金，在 2027 年認股權證到期之前，還有 1760 萬美元的潛在資金。接下來，我將把發言權交還給羅布，請他作總結發言。

Thank you, Brandi. This year has been one of bold ambition and disciplined execution. We're delivering on our programs and actively shaping the future we believe is possible. Enrollment remains strong across all three of our ongoing pivotal trials, Voyage, Panorama and Emerge, and we are eager to continue this momentum with the initiation of our second pivotal MDD trial, Ascend in mid-2026. At the same time, we're advancing MM402 into a Phase II study, a meaningful milestone as we work to bring much needed innovation to the ASD community.

謝謝你，布蘭迪。今年是充滿遠大抱負並嚴格執行的一年。我們正在落實各項計劃，並積極塑造我們認為可能的未來。我們正在進行的三項關鍵性試驗 Voyage、Panorama 和 Emerge 的入組情況依然強勁，我們渴望在 2026 年年中啟動第二項關鍵性 MDD 試驗 Ascend，以保持這一勢頭。同時，我們正在推動 MM402 進入 II 期研究階段，這是我們為 ASD 群體帶來急需創新成果的一個重要里程碑。

2026 is shaping up to be a defining year in our evolution, one where science, purpose and precision converge to advance the therapeutic potential of MM120 in our broader pipeline. With a strong balance sheet and a late-stage pipeline with multiple catalysts in the year ahead, we're excited to continue driving value for our shareholders and the millions of patients who deserve more than better. Of course, none of this progress will be possible without our exceptional team whose passion, commitment and unmatched execution continue to set the standard for our field. Thank you, again, for joining our call today. We will now open the line for questions.

2026 年將成為我們發展歷程中具有決定性意義的一年，在這一年中，科學、目標和精準將匯聚一堂，以推進 MM120 在我們更廣泛的研發管線中的治療潛力。憑藉強勁的資產負債表和未來一年內將迎來多個催化劑的後期研發管線，我們很高興能夠繼續為股東和數百萬值得擁有更好醫療服務的患者創造價值。當然，如果沒有我們傑出的團隊，這一切進展都不可能實現。他們的熱情、奉獻精神和無與倫比的執行力不斷為我們這個領域樹立標竿。再次感謝您今天參加我們的電話會議。現在我們將開放提問通道。

(Operator Instructions)

（操作說明）

Gavin Clark-Gartner, Evercore.

Gavin Clark-Gartner，Evercore。

This is Yesha on for Gavin. We just had a brief one on the blinded sample size re-estimation. Mostly wondering if this has been completed. And if so, given that the trial size expectation is still 200 patients, is it reasonable to assume that the trial is not being upsized?

這裡是耶莎替加文報道。我們剛才簡要討論了盲法樣本量重新估計的問題。我主要是想知道這件事是否已經完成了。如果是這樣，考慮到試驗規模預期仍然是 200 名患者，是否可以合理地假設試驗規模沒有擴大？

Thanks so much, Yesha. Yes, we haven't disclosed anything about a public disclosure of our sample size re-estimation. And I don't know you're referring to the ability to increase the sample size to maintain 90% power in both Voyage and Panorama, our two GAD studies. So, we continue to be excited by enrollment and on track for a readout in that program next year but have yet to say anything publicly about those announcements.

非常感謝你，耶莎。是的，我們尚未公開披露有關樣本量重新估計的任何資訊。我不知道您指的是在我們的兩項 GAD 研究 Voyage 和 Panorama 中增加樣本量以保持 90% 功效的能力。因此，我們對招生情況感到興奮，並預計在明年公佈該計畫的進展情況，但尚未就這些公告公開發表任何意見。

Pete Stavropoulos, Cantor Fitzgerald.

皮特·斯塔夫羅普洛斯，康托·菲茨傑拉德。

This is Sarah Medeiros on for Pete. Congrats on the progress in your quarter. Really two questions for you. The first one being, just curious to know how easy or difficult it is to find patients that are willing to enroll in the psychedelic -- that are willing to enroll that are psychedelic inexperienced and they're naive with all the attention focused on this class of drugs for psychiatric indications. And is there a specific demographic that are willing to enroll such as age of patients?

這裡是 Sarah Medeiros 為 Pete 報道。恭喜你本季的進展。我其實有兩個問題想問你。首先，我只是好奇，要找到願意參加迷幻藥治療的患者有多容易或多難——這些患者沒有迷幻藥經驗，而且對這類藥物在精神疾病治療方面的關注度還很低。是否有特定族群（例如患者年齡）更願意參與？

Yes. Thanks so much for the question, Sarah. I'll turn that over to Dan to maybe fill.

是的。莎拉，非常感謝你的提問。我會把那件事交給丹，讓他來填。

Yes. So -- well, I would never say that enrolling a trial is easy because obviously, that's something that we pursue on a daily basis and think about how to get the right patients into our trials. What we have maintained and what we strive for is a representative sample so that we see a background epidemiological rate of people who have some psychedelic experience hovering around 15%. And that tends to be what we aim for in our studies. We want to have a sample that looks like the general GAD population.

是的。所以——嗯，我絕對不會說招募試驗參與者很容易，因為很顯然，這是我們每天都在努力做的事情，我們會思考如何讓合適的患者參與我們的試驗。我們一直堅持並努力爭取的是一個代表性的樣本，以便我們能夠看到有迷幻體驗的人群的背景流行病學比率徘徊在 15% 左右。而這往往也是我們在學習中追求的目標。我們希望樣本能夠代表一般的 GAD 族群。

And so that's what we ended up with in our Phase IIb study, and that's what we're striving for in our Phase III study, where we're using meaningfully the same inclusion/exclusion criteria. So, despite there being attention on these studies and attention on the category, of course, for those of us who are in it, that attention is much more obvious. Many of the participants who encounter our studies are just people who are looking for studies for their GAD or MDD. And for the vast majority don't find the studies because they're specifically looking for a study in the psychedelic category or even necessarily our study.

因此，這就是我們在 IIb 期研究中最終得到的結果，也是我們在 III 期研究中努力追求的目標，我們在 III 期研究中使用了基本上相同的納入/排除標準。所以，儘管這些研究和這個類別都受到了關注，當然，對於我們這些身處其中的人來說，這種關注就更加明顯了。許多參與我們研究的人只是想尋找有關 GAD 或 MDD 的研究。而絕大多數人找不到這些研究，因為他們專門尋找迷幻藥類別的研究，甚至不一定是我們的這項研究。

Great. And just a follow-up, your earlier-stage asset, MM402, can you help us understand the biological and therapeutic rationale and ASP and what outcomes would look like and potentially study design in terms of chronic administration? And are you looking at-home administration?

偉大的。還有一個後續問題，關於您早期階段的資產 MM402，您能否幫助我們了解其生物學和治療原理、平均銷售價格 (ASP) 以及長期給藥的預期結果和潛在的研究設計？您是否考慮過在家管理？

It's a great question. And obviously, a lot of the attention on the company recently has been on our lead asset, of course, that we're very excited about MM402. The interesting feature of how we are thinking about using R-MDMA or MM402 is that in our development plan, we are developing it as a drug that would be taken either daily or as needed.

這是一個很好的問題。顯然，最近公司受到的關注主要集中在我們的主導資產上，當然，我們對 MM402 感到非常興奮。我們考慮使用 R-MDMA 或 MM402 的一個有趣之處在於，在我們的開發計劃中，我們將其開發成一種可以每天服用或按需服用的藥物。

So, the analogous set of drugs would be psychostimulants and ADHD, where people with attentional difficulties are able to use psychostimulants to enhance their ability to pay attention when they're in environments or doing activities that would benefit from that. So, depending on the conversation people have with their doctor that might be at school or for family events or whatever else is deemed appropriate by the care provider and the patient working together. So, we very much see 402 working in that direction. The specific acute effects and transient effects, obviously of 402 or R-MDMA are enhanced social awareness, social communication. People become more attuned to their own emotions, potentially the emotions of others.

因此，類似的藥物就是精神興奮劑和過動症，注意力不集中的人可以使用精神興奮劑來增強他們在需要集中註意力的環境或活動中的注意力。因此，這取決於人們與醫生的談話，談話可能發生在學校、家庭活動或其他任何醫護人員和患者共同認為合適的場合。所以，我們非常看好 402 朝著這個方向發展。402 或 R-MDMA 的具體急性效應和短暫效應顯然是增強社交意識、社交溝通。人們會更關注自己的情緒，也可能更關注他人的情緒。

And of course, a core challenge for folks who have ASD is and can be a difficulty with those sorts of social communication situations and awareness of emotions in themselves and others. So, we think the very direct effect of the drug while it's on board is exactly what will support people with those challenges. As we've now disclosed, we're moving toward an early sign of efficacy study where we'll look for indications that the drug is doing the thing that we think it will, based on the preclinical and some academic clinical evidence. And obviously, that will guide our ongoing development of the drug.

當然，對於患有自閉症的人來說，一個核心挑戰是，他們可能很難應對這類社交溝通情境，並且難以意識到自己和他人的情緒。所以，我們認為藥物在體內發揮的直接作用，正是能夠幫助人們應對這些挑戰的關鍵。正如我們現在已經披露的那樣，我們正在推進一項早期療效跡象研究，我們將尋找藥物是否能達到我們認為它能夠達到的效果的跡象，這是基於臨床前研究和一些學術臨床證據得出的結論。顯然，這將指導我們繼續進行藥物研發。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，加拿大皇家銀行資本市場。

This is Nevin on for Brian. Congrats on a good quarter so far and all the updates. Just had a question on some of the read-throughs or potential read-throughs we saw from one of the other competitors in the field who had recently updated on a more accelerated timeline as well for one of their studies. Is there perhaps an underlying reason as to why, in this case, the Emerge study got accelerated, but not the GAV studies and I think with the competitor as well, it was in a depression study. So, does it have anything to do with the particular indication that you're looking at?

這裡是內文替布萊恩報道。恭喜本季迄今取得良好業績，以及所有更新資訊。我剛剛收到一個問題，是關於我們從該領域的另一位競爭對手那裡看到的一些通告或潛在通告，他們最近也更新了一項研究的更快時間表。或許有某種潛在原因，導致 Emerge 研究得以加速，而 GAV 研究卻沒有，而且我認為競爭對手的研究也是如此，因為那是一項憂鬱症研究。那麼，這和您正在查看的特定指標有關嗎？

Or does that have more to do with the excitement around psychedelics?

或者，這與人們對迷幻藥的興奮有關？

And then, is there any additional clarity or granularity you might be able to provide on the timing for Voyage and Panorama readout? How has the pace of enrollment in those pivotals compared to what you saw in the Phase IIb?

那麼，您能否提供關於航程和全景讀數時間的更詳細說明或更具體的資訊？與 IIb 期試驗相比，這些關鍵性試驗的入組速度如何？

Yes. Thanks so much for the question, Nevin. Yes, obviously, we can't speak to other companies and what they're doing in their trials, but we've been really encouraged across the board and enrollment has been strong across all three of our ongoing studies. And, again, we continue to be really encouraged and committed to hitting our timelines with readouts next year.

是的。非常感謝你的提問，內文。是的，顯然我們無法評論其他公司在試驗中的做法，但我們總體上受到了很大的鼓舞，我們正在進行的三項研究的招募情況都非常強勁。而且，我們再次感到非常鼓舞，並致力於按計劃在明年發布相關數據。

With Emerge, we certainly got started with that study quite early in terms of the window of time we had initially indicated and continue to see enrollment strong across the board. We don't certainly believe there's any distinct difference between GAD and MDD and continue to see a lot of engagement and throughput and randomizations across all three of the studies. So, we're on track and excited about getting two top-line readouts as guided next year.

對於 Emerge 項目，我們確實很早就開始了這項研究，比我們最初設定的時間窗口要早得多，而且我們看到各個方面的招募情況都十分強勁。我們並不認為 GAD 和 MDD 之間存在任何明顯的區別，並且繼續看到所有三項研究中都存在大量的參與、吞吐量和隨機化。所以，我們一切進展順利，並期待明年能如期獲得兩項主要績效報告。

And if I may just ask a follow-up as well. So, given that the Emerge study looks like it's -- will read out a little over a year after it started, could we assume a similar time frame for the Ascend trial as well, perhaps maybe a little bit more just given the increased sample size?

如果可以的話，我再問一個後續問題。鑑於 Emerge 研究似乎將在開始一年多後得出結果，我們是否可以假設 Ascend 試驗也有類似的時間框架，甚至可能因為樣本量增加而需要更長時間？

And then a broader question, just given some of the recent -- given the recent fundraise and the strong cash position, why not just initiate the MDD studies or the Phase III Ascend study even sooner? Why wait -- or what's the rationale for waiting until the first one reads out?

那麼，還有一個更廣泛的問題，鑑於最近的一些情況——鑑於最近的融資和強勁的現金狀況，為什麼不更早啟動 MDD 研究或 III 期 Ascend 研究呢？為什麼要等——或者說，為什麼要等到第一個結果出來之後再等？

Yes. Thanks. With the recent financing, and we feel incredibly fortunate with the support we've received and where it positions us going into next year, and we're accelerating on everything that we're doing. So, we are certainly not sitting on our hands and waiting for anything. We like to set timelines where we feel confident we can deliver, and that's really informed how we thought about the timelines that have been announced.

是的。謝謝。憑藉最近的融資，我們感到非常幸運，得到了各方的支持，這讓我們在明年處於有利地位，我們正在加快所有工作的步伐。所以，我們當然不會袖手旁觀，坐著等任何事情發生。我們喜歡設定我們有信心能夠完成的時間表，而這正是我們考慮已公佈時間表的重要依據。

But of course, any opportunity we have to accelerate those timelines and bring in study initiations and bring in data readouts earlier than anticipated, we certainly will take advantage of those. So, all systems go across the board in both programs and everything we're doing.

當然，任何能夠加快這些時間表、提前啟動研究和提前獲得數據讀數的機會，我們一定會充分利用。因此，所有系統在兩個專案中以及我們正在做的所有事情中都是全面適用的。

Matthew Hershenhorn, Oppenheimer.

馬修‧赫申霍恩，奧本海默。

Congrats on all the progress. So, congrats on the JAMA publication. Could you please share any physician feedback you've received on that so far? And generally, just what that publication means for the psychiatry community? And are there any details from the data, just based on your discussions that you believe might still remain underappreciated?

祝賀你們取得的所有進展。恭喜你在 JAMA 發表文章。能否請您分享一下目前為止您收到的任何醫師回饋？那麼，該出版物對精神醫學界究竟意味著什麼呢？根據你們的討論，數據中還有哪些細節你們認為可能尚未被充分重視？

And then I just had one follow-up.

然後我還有一次後續跟進。

Yes, I'll turn that over to Dan.

好的，我會把這件事交給丹。

Yes. Everything about the way we planned, conducted and ultimately wrote about that study was meant to be digestible, familiar study design and analytic plan that physicians and others in the space would be able to read and fully understand. We've made real effort to make claims that were deeply supported by the evidence we were able to generate, and obviously, the conclusions we were able to draw from the study that have allowed us to move forward with breakthrough designation and into a Phase III program that looks in many -- basically all design ways, except for the number of arms, nearly identical to the successful Phase II. So, I think across the board, that's recognized and appreciated in the physician community and in all the other stakeholders we engage with. So, the reaction has been overwhelmingly positive.

是的。我們從規劃、實施到最終撰寫該研究報告的每一個環節，都力求使研究設計和分析方案易於理解，讓醫生和該領域的其他人能夠閱讀並完全理解。我們確實努力提出一些說法，這些說法得到了我們所能獲得的證據的有力支持，顯然，我們從研究中得出的結論也使我們能夠推進突破性療法認定，並進入 III 期臨床試驗計畫。這個計畫在許多方面——基本上所有設計方面，除了手臂的數量之外——都與成功的 II 期臨床試驗項目幾乎相同。因此，我認為這一點在醫生群體以及我們所接觸的所有其他利益相關者中都得到了普遍認可和讚賞。所以，反響絕大多數都是正面的。

And we're proud of the work we did, and we're really glad for what it indicates about what we anticipate being able to show in the Phase III programs. I think when it comes to underappreciated perhaps the nature of a single monotherapy intervention without any assisted therapy being able to induce remission in just under 50% of the patient population who start with, on average, severe GAD and looking 12 weeks later and seeing that remission rate from a single intervention. I think even -- no matter how much we look at these data and we look at them probably more than anybody, that still strikes me as just being truly, truly a remarkable opportunity for potential sea change in psychiatry.

我們為我們所做的工作感到自豪，並且非常高興它預示著我們預計在第三階段專案中展示的內容。我認為，人們可能低估了單一療法介入的性質，即在沒有任何輔助療法的情況下，能夠使近 50% 的患者群體（平均而言，這些患者一開始患有嚴重的 GAD）病情得到緩解，而 12 週後觀察，就會發現這種緩解率來自單一幹預。我認為，即便——無論我們如何研究這些數據（而且我們研究這些數據的程度可能比任何人都高），這仍然讓我覺得，這對精神病學而言，確實是一個意義非凡、可能帶來巨大變革的機會。

And then the one other question we had was just, if you don't mind, talk about just from the commercial opportunity, how you plan to practically manage patients considering the 8-hour in-clinic administration time, just considering we get a lot of questions on the perceived challenges that you could potentially solve for in the real-world setting. And maybe if you could talk about that in the context of SPRAVATO in terms of the aggregate treatment time over a year, would definitely appreciate it.

我們還有一個問題，如果您不介意的話，能否從商業機會的角度談談，考慮到 8 小時的診所給藥時間，您打算如何實際管理患者？因為我們經常收到關於您在實際環境中可能解決的挑戰的問題。如果您能結合 SPRAVATO 的實際情況，談談一年的總處理時間，我將不勝感激。

Yes. Thanks so much. I think that when we talk about Spravato, obviously, there's been a lot of attention paid, and it's really encouraging. I think it's -- the most encouraging signals there are the reality that psychiatry has and will adapt to the introduction of new treatment options. But the dynamics of -- as you referenced, the dynamics and the durability of response after Spravato session are in stark contrast to the long-lasting durable effects that we've seen so far with MM120.

是的。非常感謝。我認為，當我們談到 Spravato 時，顯然它受到了廣泛的關注，這真的很令人鼓舞。我認為最令人鼓舞的訊號是，精神病學已經並將繼續適應新治療方案的引入。但是，正如您所提到的，Spravato 療程後的動態和反應持久性與我們目前在 MM120 中看到的持久效果形成了鮮明的對比。

So certainly, the -- there are some parallels. There are some dynamics from an infrastructure and delivery standpoint, things that have been worked out since the launch of Spravato that we certainly believe we can leverage. But it's really almost an apples-and-oranges comparison when we think about the treatment dynamics and the benefits that we've been able to show so far in our clinical trials. And so, that just speaks to the overwhelming desire for MM120 that we hear from both patients and providers when we go out and conduct research with those groups. And so, again, there's certainly -- MM120 is not and was not ever intended to be a replica of Spravato.

所以，當然，兩者之間有些相似之處。從基礎設施和交付的角度來看，有一些動態因素，這些因素自 Spravato 推出以來已經解決，我們相信我們可以加以利用。但當我們考慮治療動態以及我們在臨床試驗中迄今為止所展現的益處時，這實際上幾乎是蘋果和橘子的比較。因此，這正反映了我們在與患者和醫療服務提供者進行研究時，他們所表達的對 MM120 的強烈渴望。所以，再次強調，MM120 絕對不是，也從來不是 Spravato 的複製品。

We think it offers some significant advantages both in terms of the magnitude of change and the durability of that change. that positioned incredibly well.

我們認為，無論從變革的幅度或變革的持久性來看，它都具有顯著的優勢，定位非常有利。

So again, great learnings, great infrastructure that can be leveraged, but a totally different dynamic and one we think is quite favorable compared to any drugs that are on the market today for these indications.

所以，我們再次獲得了寶貴的經驗，也擁有可以利用的完善基礎設施，但這是一種完全不同的動態，我們認為與目前市場上用於這些適應症的任何藥物相比，這種動態都相當有利。

Francois Brisebois, LifeSci Capital.

布里斯博瓦 (Francois Brisebois)，生命科學資本。

Just, the first one I had was on the market potential here between MDD and GAD. Can you just talk a little bit about the overlap? And obviously, these are massive, massive markets, but can one cannibalize the other here? Or just maybe a better understanding of the difference here between both?

我遇到的第一個問題是 MDD 和 GAD 之間的市場潛力。能簡單談談重疊部分嗎？顯然，這些都是規模龐大的市場，但它們之間會互相蠶食嗎？或者，或許只是想更好地理解這兩者之間的差異？

Yes. I'll turn it over to Dan too to talk about it clinically in a second. From a market opportunity, there certainly is a long history of drugs being labeled for both MDD, GAD and other indications in psychiatry. Some of the biggest drugs in psychiatry historically have been labeled for both of these indications. And typically, those drugs and speaking about SRIs here have started with an MDD label and then expanded into GAD, and we think that's representative of the challenges and the limitations of those drugs in treating GAD symptoms.

是的。我稍後會把麥克風交給丹，讓他從臨床角度談談這個問題。從市場機會來看，藥物被貼上用於治療重度憂鬱症、廣泛性焦慮症和其他精神病學適應症的標籤，這確實由來已久。從歷史上看，精神病學領域中一些最重要的藥物都曾被批准用於治療這兩種疾病。通常情況下，這些藥物，尤其是這裡提到的 SRI 類藥物，最初是針對 MDD 的，然後擴展到 GAD，我們認為這代表了這些藥物在治療 GAD 症狀方面所面臨的挑戰和局限性。

So, while there's certainly a high degree of overlap, we don't think about it as -- so much as cannibalizing anything as much as offering an opportunity to essentially treat two core symptom clusters that are overlapping in the diagnosis. But in an ideal outcome, any patient who walks in the door with anxiety or depression symptoms and qualifies as diagnosis could then be directed to MM120 if we're successful getting both of these indications on the label. But I'll turn it over to Dan maybe to comment a little bit more about the clinical presentation.

因此，雖然兩者之間確實存在高度重疊，但我們並不認為這是相互蠶食，而是提供了一個機會，可以有效地治療診斷中重疊的兩個核心症狀群。但理想情況下，如果我們成功地將這兩種適應症都納入標籤，那麼任何出現焦慮或憂鬱症狀並符合診斷標準的患者都可以被轉診至 MM120。不過，我可能會把麥克風交給丹，讓他再多談談臨床表現。

Yes. And thanks for the question, Frank. The overlap between these two disorders is a really interesting phenomenon. And the way that we have come to think of this is that while there are certainly patients who have a major depressive episode and as a result, are diagnosed with major depressive disorder who don't have GAD level of anxiety between their depressive episodes. So, while they're euthymic, they don't have depression.

是的。謝謝你的提問，弗蘭克。這兩種疾病之間的重疊現象非常有趣。我們逐漸認識到，雖然確實有一些患者經歷了一次重度憂鬱發作，並因此被診斷為重度憂鬱症，但他們在憂鬱症發作之間並沒有出現 GAD 等級的焦慮。所以，雖然他們情緒正常，但他們並沒有罹患憂鬱症。

And there are patients with GAD who have a high level of anxiety, which is more of a constant thing, not episodic, who don't go on to have a major depressive episode. For 50% to 80% of people who have either diagnosis, they would qualify for both. And that means that these are people who have had generally a pretty high level of background anxiety often for most of their lives. And because they don't really know you're not supposed to feel that way and until recently, there wasn't really a screening recommendation for anxiety disorders. So that, of course, changed in the last three years with USPSTF recommendations for anxiety screening.

還有一些患有廣泛性焦慮症的患者，他們的焦慮程度很高，而且是持續性的，而不是間歇性的，他們不會發展成重度憂鬱發作。對於 50% 到 80% 的被診斷出患有其中一種疾病的人來說，他們符合兩種疾病的治療條件。這意味著這些人通常一生中大部分時間都處於相當高的背景焦慮狀態。因為他們並不真正了解你不應該有這種感覺，而且直到最近，還沒有針對焦慮症的篩檢建議。當然，在過去三年裡，隨著美國預防服務工作小組（USPSTF）關於焦慮症篩檢的建議，情況發生了變化。

It's just like, this is how you're supposed to feel and people often have a intellectualized way of thinking about it, which is to say, well, the world is a scary and dangerous place. So of course, I'm anxious all the time. Many of those folks will then go on to have a major depressed episode at which point because of the episodic nature of the condition, they'll end up seeking care in a world where there was more screening for depression because that recommendation has been around for a lot longer and because there's just this change in condition from one day to the next. So that will lead people then to potentially seek care on the onset of major depressive episode. So like Rob said, addressing one set of symptom of the symptom cluster, so getting to the anxiety side of things or the more anhedonic depression side of things rather than being worry about cannibalizing a market, it's much more about being able to provide people an overall relief from their distress than drugs that they just have shown efficacy for ending a major depressive episode and leave people with this euthymic but highly anxious state between those depressive episodes.

就好像，你應該有這種感覺，人們常常用理性的方式去思考這個問題，也就是說，嗯，世界是個可怕而危險的地方。所以，我當然一直都很焦慮。這些人中許多會發展成重度憂鬱症，此時由於憂鬱症的間歇性，他們最終會尋求治療。而如今，憂鬱症篩檢已經普及很多，因為這項建議已經存在很久了，而且病情也可能在一夜之間改變。這樣一來，人們在出現重度憂鬱症發作時就有可能尋求治療。就像羅布所說的那樣，針對症狀群中的一組症狀，也就是焦慮或快感缺失型抑鬱症，與其擔心蠶食市場，不如說是能夠為人們提供整體的痛苦緩解，而不是像藥物那樣，僅僅證明其能有效結束重度抑鬱發作，卻讓人們在抑鬱發作之間處於一種心境正常但高度焦慮的狀態。

So we're really enthusiastic about having been able to demonstrate the efficacy we did in Phase II for GAD and the remarkable effect that we were able to show in those patients on MADRS scores. So, we're highly optimistic about our Phase III program in MDD as well. And again, just seeing this as additive benefit for people who, in the majority of cases are suffering from, in essence, both.

因此，我們非常高興能夠證明我們在 II 期臨床試驗中對 GAD 的療效，以及我們在這些患者的 MADRS 評分上所展現的顯著效果。所以，我們對MDD的第三階段試驗計畫也充滿信心。再次強調，這對大多數實際上同時患有這兩種疾病的人來說，無疑是一種額外的好處。

That's great. That's really helpful. And then, maybe just the last one. In terms of the KOL education that was brought up in terms of something to work on in the future. And -- but I was just wondering for a field that hasn't had a lot of new options in a long time, what do you think will be the biggest hurdles here with KOLs?

那太棒了。這真的很有幫助。然後，也許就只有最後一個了。就KOL教育而言，這是未來需要努力的方向。而且──我只是想知道，在一個長期以來沒有太多新選擇的領域，你認為KOL（關鍵意見領袖）面臨的最大障礙是什麼？

Is it easy where the data speaks for itself? Or do you expect the different tiers of KOLs where some guys are a lot more willing to try something new and maybe earlier in the treatment paradigm. I'm just wondering where you think the biggest challenges might be here for the KOL education process.

數據本身就能說明問題，這很容易嗎？或者您認為 KOL 會有不同層級，其中一些更願意嘗試新事物，並且可能更早參與治療方案？我只是想知道您認為KOL教育過程中最大的挑戰可能在哪裡。

Yes. Having been out in the world in the conferences and working with a lot of these KOLs over the last several years, we are incredibly encouraged by the strong desire for something new and encouraged by the -- I think the respect that high-quality evidence has garnered from KOLs and from practicing psychiatrists almost at every level. And so, we can't -- almost can't overstate how enthusiastic many of those conversations are.

是的。過去幾年，我們走遍世界各地參加會議，並與許多 KOL 合作，我們深受鼓舞，因為他們渴望新的事物，而且高質量的證據幾乎在各個層面都贏得了 KOL 和執業精神科醫生的尊重。因此，我們幾乎無法誇大這些對話的熱情程度。

Now there are undoubtedly, detractors. There's a much smaller, but there will be a segment of practicing psychiatrists who likely don't want to deliver MM120. But what we see is an overwhelming majority in our conversations of KOLs, and again, practicing psychiatrists out in the world who -- many of them say, well, I'm not set up and wouldn't deliver any of the interventional psychiatry treatments today, but I certainly have an intent to do so with MM120, should it get approved. And so, while there's going to be a major effort ahead so that we can shape the market and make sure that the world is fully aware of the exciting data we are generating, we don't see any barrier in terms of getting that engagement. And if anything, it's quite rare to see the enthusiasm that we do as a field this far and in advance of pivotal readouts and it's going back several years now.

毫無疑問，也存在著一些批評者。雖然人數較少，但確實會有一部分執業精神科醫生可能不想提供 MM120 課程。但我們在與關鍵意見領袖的對話中看到，絕大多數人，以及許多在職精神科醫生都表示，他們中的許多人說，嗯，我目前還沒有做好準備，也不會提供任何介入性精神病治療，但如果 MM120 獲得批准，我肯定會這樣做。因此，儘管我們未來還需要付出巨大的努力來塑造市場，並確保全世界充分了解我們正在產生的令人興奮的數據，但我們看不到在獲得這種參與方面有任何障礙。而且，在關鍵性結果公佈之前，我們這個領域如此高漲的熱情實屬罕見，這種情況已經持續好幾年了。

So, I remain highly encouraged but highly focused on getting that messaging right and amplifying it to the greatest extent possible.

因此，我仍然備受鼓舞，但同時也高度專注於確保訊息傳遞準確無誤，並盡可能擴大其影響力。

And does Spravato help here? Or do you consider it so different that it's not because someone prescribes Spravato that they're more likely to prescribe this here?

Spravato 能幫上忙嗎？或者您認為這兩種藥物差異很大，以至於有人開了 Spravato 並不意味著他們更有可能在這裡開這種藥？

Well, we think any infrastructure build-out that has happened certainly is something that we can leverage and for providers to -- quite frankly, for providers to be delivering as many treatment sessions of SPRAVATO as they have over the past several years and then to see something with higher magnitude, more durable effect that seems to drive a whole different outcome for some of these patients. That contrast, we feel very good about and think positions us incredibly well.

我們認為，任何已經發生的基礎設施建設肯定都是我們可以利用的，坦白說，對於醫療服務提供者來說，能夠像過去幾年那樣提供盡可能多的 SPRAVATO 治療療程，然後看到更大規模、更持久的效果，這似乎能為一些患者帶來完全不同的結果。我們對這種對比感到非常滿意，並認為這使我們處於非常有利的地位。

So certainly, we think there is a segment of psychiatry that is delivering not only Spravato, but other interventional psychiatric treatments. And those tend to be some of the earlier adopters and some of those folks who are the most enthusiastic, but it is certainly not limited to Spravato centers or providers who are coming to us and talking about their enthusiasm for what MM120 could offer patients.

因此，我們認為精神病學領域的一部分不僅提供 Spravato，還提供其他介入性精神病治療。這些人往往是較早採用者，也是最熱情的人，但這當然不僅限於 Spravato 中心或前來與我們談論他們對 MM120 能為患者帶來的益處的供應商。

Ami Fadia, Needham & Company.

Ami Fadia，Needham & Company。

Congrats on the quarter. My first question is, can you talk about the persistency rates of patients in Voyage and Panorama studies that you're seeing on a blinded basis and how that might be progressing relative to the dropout rates that you had assumed in the trial design? And in terms of what we can expect from a communication perspective, should we assume that when you do conduct the sample size re-estimation, that will not be made public? And then I have one or two other questions.

恭喜你本季取得佳績。我的第一個問題是，您能否談談您在盲法條件下觀察到的 Voyage 和 Panorama 研究中患者的堅持率，以及相對於您在試驗設計中假設的脫落率，該堅持率的進展情況？從溝通的角度來看，我們是否可以假設，當您進行樣本量重新估計時，該結果不會對外公佈？我還有一兩個問題。

Yes. Thanks so much for the question. We won't comment on ongoing studies or even unblinded data from those studies until we hit a point of having data and being able to announce fully the outcomes of a study. But we certainly have been really encouraged on a lot of the metrics, but -- and really all of the metrics that we've been measuring in the trials and continue to be committed to executing these studies with the highest quality and on time and get to results at appropriate time next year. And again, we haven't commented specifically on whether or not we would announce a sample re-estimation publicly or not.

是的。非常感謝你的提問。在獲得數據並能夠全面公佈研究結果之前，我們不會對正在進行的研究，甚至不會對這些研究中未公開的數據發表評論。但我們確實在許多指標上都受到了很大的鼓舞，而且——實際上，我們在試驗中衡量的所有指標都取得了成功，我們將繼續致力於以最高的品質和時間完成這些研究，並在明年適當的時候獲得結果。此外，我們尚未就是否會公開宣布樣本重新估算發表具體評論。

Got it. And then, in the Panorama and the Ascend studies where you have 2 doses of MM120, once we get the results and especially from a regulatory perspective, how much of a difference across the doses would you like to see or do you think the FDA would like to see in terms of efficacy and safety to be able to address the functional unblinding question or maybe a dose-dependent change across the doses question?

知道了。然後，在 Panorama 和 Ascend 研究中，MM120 有兩種劑量，一旦我們得到結果，特別是從監管角度來看，您希望看到不同劑量之間有多大的差異，或者您認為 FDA 希望看到在療效和安全性方面有多大的差異，以便能夠解決功能性揭盲問題，或者劑量依賴性變化問題？

Well I think the important point there is about the need for programs to demonstrate dose response. So, when we think about things like functional unblinding, which are problems across all of psychiatry, anything really in the CNS, of course. We think demonstration of dose response is really critical and gives a high degree of confidence in there being a real treatment effect of a drug. And that's why we did the Phase II study we did and uniquely in our field have comprehensively characterized the dose response.

我認為重點在於需要透過試驗來證明劑量反應。所以，當我們思考諸如功能性揭盲之類的問題時，這在整個精神病學領域都是一個問題，當然也包括中樞神經系統中的任何問題。我們認為劑量反應的證明至關重要，它能讓人高度確信藥物確實具有治療效果。正因如此，我們才開展了 II 期研究，並在我們這個領域獨樹一幟地全面表徵了劑量反應。

We have a study that has been completed and published and that we're really excited about, of course, that demonstrated both clinically from an observational standpoint, but also statistically that there is a dose response. And that was even in light of the fact that virtually all patients regardless of the dose of active drug they received reported being functionally unblinded by correctly guessing that they were on drug. And so, there's not really a question at this point in our minds about whether there is a dose response because we did a dedicated study to demonstrate that and that successfully proved that there is. And so, the availability, the existence of the lower dose, the 50-microgram arm really is a prospective use in the study and that it allows us in the [consent] process confound expectations to effectively say to a patient, if you were to feel the effects of drug on the day of dosing, you can't assume it's the full real dose of drug.

我們已經完成並發表了一項研究，我們對此感到非常興奮，當然，該研究從臨床觀察的角度以及統計學角度都證明了存在劑量反應關係。即使考慮到幾乎所有患者，無論他們接受的活性藥物劑量如何，都報告說他們通過正確猜測自己正在服用藥物而實際上已經失去了盲法，情況也是如此。因此，目前我們並不懷疑是否存在劑量反應關係，因為我們已經進行了一項專門的研究來證明這一點，並且成功地證明了存在劑量反應關係。因此，較低劑量（50 微克）的存在，實際上是這項研究的一個前瞻性用途，它允許我們在（知情同意）過程中混淆預期，有效地告訴患者，如果您在給藥當天感覺到了藥物的效果，您不能假設這就是藥物的全部實際劑量。

It actually is the dose of drug in the prior study that we showed is functionally unblinding but does not have clinical activity in reducing anxiety symptoms. And so, it is a design element and a functional control in the study. But in terms of the outcomes of the data, primary outcome measures in both Voyage and Panorama and in Emerge and Ascend is testing 100 micrograms versus placebo and no outcome of the 50-microgram group can alter the finding of that primary analysis. So, regardless of what happens in terms of the group response to 50 micrograms, we'll be seeking to clinically and statistically prove that MM120 100 micrograms is superior to placebo.

實際上，我們在先前的研究中已經證明，該藥物劑量雖然可以解除盲法，但對減輕焦慮症狀沒有臨床療效。因此，它是本研究中的一個設計元素和功能控制因素。但就數據結果而言，Voyage 和 Panorama 以及 Emerge 和 Ascend 的主要結果指標是測試 100 微克與安慰劑的對比，50 微克組的任何結果都無法改變該主要分析的結果。因此，無論 50 微克劑量的群體反應如何，我們都將尋求從臨床和統計學角度證明 MM120 100 微克優於安慰劑。

Got it. That's very helpful. Maybe my last question, if I could squeeze one in. The feedback that we've received from a lot of KOLs is that the key differentiating factor and maybe a huge unmet need is the potential to reduce the frequency of retreatment. Can you comment on any follow-up orexperience from the Phase II that can throw some light on what is the range of timeframe within which patients will require a retreatment?

知道了。那很有幫助。如果可以的話，這可能是我最後一個問題。我們從許多 KOL 得到的回饋是，關鍵的差異化因素，或許也是一個巨大的未滿足的需求，是降低復治頻率的潛力。您能否就二期臨床試驗的後續進展或經驗發表一些評論，以闡明患者需要再次治療的時間範圍？

Yes. So, what we saw in terms of the average curves and response is that we didn't see any deterioration of effect out to 12 weeks. And because of that, we can't really even attempt to project those curves and arrive at a time when we would anticipate reliably that patients would need a retreatment. And of course, we're trying to characterize that in Part B of our Phase III studies that are ongoing and planned.

是的。因此，從平均曲線和反應來看，我們在 12 週內沒有看到任何效果惡化。正因如此，我們根本無法嘗試預測這些曲線，也無法可靠地預測患者何時需要再次治療。當然，我們正在進行和計劃中的 III 期研究的 B 部分中嘗試對此進行描述。

We certainly hear and have looked at real-world use, the compassionate use programs and have been encouraged by the durability of LSD that can last well beyond 12 weeks in some of those studies and are really excited to characterize that in a robust fashion in our Phase III program. But it's a little bit premature to say decisively or exactly where we expect retreatment, although what we do know is that -- and we believe we have alignment around the right approach to characterizing this is to do exactly what we're doing in the Part B of the Phase III studies, which is to screen patients and when they have a recurrence of symptoms, having a 16 or greater or a MADRS of 20 greater depending on the study, the availability of open-label retreatment and to try to characterize those dynamics, the intervals between doses and the ultimate frequency over the course of a 12-month period in the study. So, really excited to get to those data, but a little bit premature to say so today.

我們當然聽說過並研究過現實世界中的使用情況、同情使用計劃，並且對 LSD 的持久性感到鼓舞，在某些研究中，LSD 的藥效可以持續超過 12 週，我們非常興奮地希望在我們的 III 期項目中以強有力的方式來描述這一點。但現在就斷言或確切地說我們預期何時進行再治療還為時過早，儘管我們知道——而且我們相信我們已經就描述這種情況的正確方法達成了一致——那就是完全按照我們在 III 期研究 B 部分中所做的那樣進行，即篩選患者，當他們出現症狀復發時（根據研究的不同，MADRS 評分達到 16 分或更高，或 MADRS 評分分或更高），開放標籤再治療的可用性，並嘗試描述這些動態、給藥間隔以及在 12 個月的研究期間的最終頻率。所以，我非常期待獲得這些數據，但現在下結論還為時過早。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

Nice to see the progress. I have a few. First, because MDD is more episodic versus GAD that has more chronic characteristics. Do you expect any difference in durability of effect with MM120? And what could that mean for a number of treatments per year for each indication?

很高興看到取得進展。我有一些。首先，因為 MDD 更具發作性，而 GAD 則具有更多慢性特徵。您認為 MM120 在效果持久性方面會有什麼不同嗎？那麼，對於每種適應症，每年需要進行多少次治療呢？

And would you expect price per treatment for MM120 to be the same in GAD and MDD? And then I have a follow-up.

您認為 MM120 治療 GAD 和 MDD 的單次治療價格會相同嗎？然後我還有一個後續問題。

Yes. Thanks so much, Sumant. Exactly why we're doing the studies is to try to characterize that. We believe that based on what we've seen and that the curves as I was describing for both anxiety and depression symptoms in the Phase II, we saw somewhat similar response patterns. And so we're certainly very focused and very interested in characterizing those treatment responses and retreatment characteristics, and that will certainly inform everything from how we approach clinical regulatory and pricing discussions.

是的。非常感謝你，蘇曼特。我們進行這些研究的目的正是為了試圖描述這種現象。我們認為，根據我們所看到的，以及我在第二階段所描述的焦慮和憂鬱症狀的曲線，我們看到了某種相似的反應模式。因此，我們非常關注並非常感興趣於描述這些治療反應和再治療特徵，這肯定會影響我們如何進行臨床監管和定價方面的討論。

Got it. And the follow-up, if we look at Slide 23 in the MM120 commercial framework of your latest slide deck, it says psychotherapy is not offered or required, but may be added outside a dosing session based on individual needs and goals. So, in real-world usage, what percentage of patients do you think this might be applicable to? And how would that impact commercial or reimbursement-based variables?

知道了。此外，如果我們看一下您最新幻燈片中 MM120 商業框架的第 23 張幻燈片，上面說心理治療不提供也不要求，但可以根據個人需求和目標在給藥療程之外添加。那麼，在實際應用中，您認為這可能適用於多少比例的患者？那會對商業或報銷相關的變數產生什麼影響呢？

Well, I think overall, we hope that every patient gets the availability of every treatment. We know that psychotherapy is not reimbursed particularly well today, and we don't -- it's not our position or place with MM120 to exactly change that. So certainly, we expect in the real world that some patients who are already in psychotherapy would be candidates for MM120 and could likely continue on.

總的來說，我們希望每位患者都能獲得所有治療方案。我們知道，如今心理治療的報銷情況並不理想，而且我們——MM120 的立場和職責也不是要改變這一點。因此，我們當然預期在現實世界中，一些已經接受心理治療的患者將成為 MM120 的候選人，並且很可能會繼續接受治療。

We've certainly, again, from observations out in the world, seen both patients in academic studies and in real-world use who are administered a psychedelic and then decide to pursue psychotherapy thereafter. So, we, of course, want to have labeling and a development program that enables the widest adoption and the widest set of use cases for MM120 should get it approved and out in the world. But we do not, as part of the development program, require or deliver any psychotherapy in our program.

我們當然也從現實世界的觀察中看到，無論是學術研究或現實生活中，都有病人在使用迷幻藥後決定接受心理治療。所以，我們當然希望透過標籤和開發計劃，使 MM120 能夠得到最廣泛的應用和最廣泛的用例，從而獲得批准並推向世界。但是，作為發展計劃的一部分，我們並沒有要求或提供任何心理治療。

Patrick Trucchio, H.C. Wainwright.

派崔克·特魯基奧，H.C. 溫賴特。

I have a couple of questions. The first is, I think you noted that the Phase III program in GAD is powered 90% to detect a 5-point improvement on the HAM-A. And I think that compare to the 7.7 point placebo-adjusted difference observed in the Phase IIb. I'm wondering if you can put that 5-point threshold into a clinical context. How should we think about the relevance to patients in real-world outcomes?

我有幾個問題。首先，我認為您已經注意到，GAD 的 III 期專案有 90% 的把握檢測到 HAM-A 評分 5 分的改善。我認為這與 IIb 期試驗中觀察到的 7.7 點安慰劑調整差異相比。我想知道您能否將這 5 分的閾值放到臨床背景下進行解釋。我們應該如何看待其與患者在現實世界中的結果的相關性？

And then just a clarification for the depression program, Emerge, have you shared how that study is powered as well and your expectations heading into that mid-2026 data readout?

另外，關於憂鬱症計畫 Emerge，您有沒有分享這項研究的資金來源，以及您對 2026 年中期數據公佈的預期？

Yes. Thanks so much for the questions, Patrick. Yes, so when we look at the context of historical and currently approved products in generalized anxiety disorder, we typically see an under 5-point placebo-adjusted change and more commonly, somewhere in the mid-3 points over placebo. And on an absolute basis, typically in the low-teens in terms of the absolute magnitude of HAM-A improvement for the approved therapies. And so, in that context, we saw almost 22-point improvement in the 7.7 placebo-adjusted delta in our Phase II study at 12 weeks after a single dose of drug.

是的。非常感謝你的提問，派崔克。是的，所以當我們查看廣泛性焦慮症的歷史和目前獲批產品的背景時，我們通常會看到安慰劑調整後的變化小於 5 分，更常見的是，比安慰劑高出 3 分左右。從絕對值來看，已批准療法的 HAM-A 改善的絕對幅度通常在十幾分左右。因此，在這種背景下，我們在 II 期研究中，單次給藥 12 週後，安慰劑調整後的 7.7 delta 值改善了近 22 個百分點。

And so, we're trying to be, of course, conservative in powering assumptions so that we can give ourselves a good probability of success. And the same approach applies. We want to see a clinically meaningful change with -- in both GAD and in MDD, and that's how we've approached the powering and design of all four of the Phase III studies.

因此，我們當然要盡量保守地做出假設，以便給自己一個較高的成功機率。同樣的方法也適用。我們希望看到 GAD 和 MDD 都出現具有臨床意義的變化，這也是我們進行所有四項 III 期研究的動力和設計方法。

So I think, earlier, 2025 described as a year of constructive dialogue with the FDA. I'm wondering if you can elaborate on key areas of alignment that have been achieved so far and what still needs to be finalized ahead of potential NDA submissions? And as well, would you anticipate submitting the NDA for GAD with the 12-week data or would you be -- would you need longer-term data from Part B prior to submitting?

所以我認為，先前有報導稱，2025 年是與 FDA 進行建設性對話的一年。我想請您詳細說明一下目前為止在哪些關鍵領域已經達成一致，以及在可能提交保密協議之前還有哪些方面需要最終確定？另外，您預計會使用 12 週的數據提交 GAD 的 NDA 申請，還是需要 B 部分的長期數據才能提交？

Yes. We've had an ongoing and incredibly constructive dialogue with FDA, and we're very grateful for their level of engagement under the breakthrough therapy designation program, and we've really taken advantage of that and try to seek an ongoing dialogue and a high degree of alignment on all the studies we're conducting, including in particular, the Phase III studies. And so, we don't tend to speak about specific agency interactions on an ongoing basis, but we do believe there's a high degree of alignment. We believe the most important data is the data that we need to demonstrate the Part A from our Phase III studies to demonstrate at 12 weeks in GAD and at six weeks in MDD that we have two studies that show hopefully the safety and effectiveness of MM120.

是的。我們與 FDA 一直保持著持續且極具建設性的對話，我們非常感謝他們在突破性療法認定計劃下的積極參與，我們也充分利用了這一點，努力尋求持續的對話，並在我們正在進行的所有研究（特別是 III 期研究）上達成高度一致。因此，我們通常不會經常談論特定的機構互動，但我們確實認為雙方具有高度的一致性。我們認為最重要的數據是我們需要從 III 期研究中證明 A 部分的數據，以便在 GAD 患者中 12 週和 MDD 患者中 6 週時證明，我們有兩項研究有望顯示 MM120 的安全性和有效性。

So that's been our approach. And again, incredibly constructive dialogue. And as we progress and deliver pivotal data over the course of 2026, we'll continue that dialogue and do everything. The team has an incredible track record of hitting our milestones and being incredibly efficient with how we operationalize our program. We continue to do that in clinical development.

這就是我們採取的方法。再次強調，這是一場極具建設性的對話。隨著我們在 2026 年取得進展並提供關鍵數據，我們將繼續進行對話並盡一切努力。該團隊在實現我們的里程碑方面有著令人難以置信的良好記錄，並且在專案運營方面效率極高。我們在臨床開發中也一直這樣做。

We intend to do that through the remaining regulatory and commercial milestones lie ahead.

我們計劃透過完成剩餘的監管和商業里程碑來實現這一目標。

Lastly, I'm wondering if you're anticipating an FDA advisory committee meeting as part of the review process for GAD and/or MDD? And how is your clinical development program position you to prepare for that discussion?

最後，我想知道您是否預計 FDA 諮詢委員會將在 GAD 和/或 MDD 的審查過程中召開會議？您的臨床開發專案如何讓您為這場討論做好準備？

Our approach has been to generate the strongest, most robust evidence and data package to stand up to any stakeholder in any form of scrutiny. And so, whether or not an advisory committee is required, we certainly will be prepared, but it's premature to say until we've got that stage of review cycle and had the dialogue with FDA at that point to say one way or another, whether an advisory committee would be required or not.

我們的做法是產生最有力、最可靠的證據和資料包，以經受任何利害關係人的任何形式的審查。因此，無論是否需要諮詢委員會，我們當然會做好準備，但在進入審查週期的那個階段並與 FDA 進行對話之前，現在就斷言是否需要諮詢委員會還為時過早。

Christopher Chen, Baird.

克里斯多福·陳，貝爾德。

Can you hear me now?

現在能聽到我說話嗎？

Yes, we can.

是的，我們可以。

Okay. Great. Yes, I apologize. I think I'm having some connection issues. Congrats on the quarter.

好的。偉大的。是的，我道歉。我好像遇到網路連線問題了。恭喜你本季取得佳績。

Just regarding the currently running Phase IIIs, can you talk a bit more about the safety monitoring in that interim 3-month period following the initial dosing? I'm just curious what guardrails are in place for patients and how you tow that line between ensuring support for these patients while not crossing over into psychotherapy? And then I do have a follow-up.

關於目前正在進行的 III 期臨床試驗，您能否詳細介紹一下首次給藥後 3 個月過渡期內的安全監測情況？我只是好奇，對於患者有哪些保障措施，以及你們如何在確保為這些患者提供支持的同時，又不越界進入心理治療領域？然後我還有一個後續問題。

Yes, I'll turn it over to Dan.

是的，我會把它交給丹。

Yes. It's a great question. And obviously, we want to ensure the safety of people as they participate in our studies. Through the entire duration of the participation per participant, that's for the full year, folks are in regular contact with the site, and we do regular AE assessments. We do regular C-SSRSs to ensure that no one has developed suicidality.

是的。這是一個很好的問題。顯然，我們希望確保參與我們研究的人員的安全。在整個參與期間（即一整年），參與者會定期與網站聯繫，我們會定期進行 AE 評估。我們定期進行 C-SSRS 評估，以確保沒有人有自殺傾向。

We are very attentive to these things. But that monitoring is completely consistent and coherent with the history of psychiatric drug development. And it says something about the category and assumptions that had been made prior to some of our research about what was required to do research in the category. And so, the difference between safety monitoring and if someone were to have a safety issue and then we needed to refer them out to a higher level of care, of course, we could do that. At that point, the person would be discontinued from the study because that would be an event leading to early termination from the study.

我們非常關注這些事情。但這種監測與精神藥物研發的歷史完全一致且相符。這說明了一些關於該類別以及在我們進行一些研究之前對該類別的研究要求所做出的假設。因此，安全監測和將某人轉診至更高級別的護理機構之間的區別在於，如果有人出現安全問題，我們當然可以這樣做。屆時，該受試者將被終止參與研究，因為這將導致其提前退出研究。

But none of that even borders attempts to change symptoms through an engagement and interaction. So, none of that -- in no way does any of that safety monitoring even touch on the sorts of interventions that would constitute psychotherapy.

但所有這些都未能透過參與和互動來改變症狀。所以，所有這些——所有這些安全監測根本沒有涉及構成心理治療的那種幹預措施。

I'll just make one final point to emphasize this. Psychotherapy is defined construct and something that has a long history. And I think there's been attempts to conflict the meaning of what that is. And so, we are very intentional about how we instruct the sites to conduct the study, and that is to specifically not deliver psychotherapy in the [conduct] of our studies, and we've maintained a high degree of adherence to that through our development program.

最後我再強調一點。心理治療是一個有明確定義且歷史悠久的概念。我認為有人試圖曲解它的意思。因此，我們非常注重指導研究中心如何進行研究，明確規定在研究過程中不得提供心理治療，並且我們透過發展計畫一直高度堅持這項原則。

Great. Great. No, super helpful. And then just real quick, just regarding the treatment session itself, do you have protocols in place just in the rare event that a patient might need to stay beyond that 8-hour time point? And then will the final data read include data on instances of that?

偉大的。偉大的。不，超級有用。那麼，就治療過程本身而言，如果患者需要停留超過 8 小時，你們是否有相應的應對方案呢？那麼最終讀取的資料是否會包含有關該實例的資料？

Premature right now to say exactly which data we'd be sharing at which point in time. We certainly intend to be complete with our disclosures at the time we have top-line data from our Phase III studies. But we have plans in place and contingency plans in place for all sorts of eventualities as any clinical trial does. But we've been really encouraged with the ODT formulation and our approach to patient safety monitoring in Phase III.

現在說我們會在哪個時間點分享哪些數據還為時過早。我們當然會在獲得 III 期研究的主要數據時，完整地揭露相關資訊。但是，就像任何臨床試驗一樣，我們已經制定了應對各種突發情況的計劃和緊急應變計畫。但是，我們對 ODT 配方以及 III 期患者安全監測方法感到非常鼓舞。

I've been really encouraged by what we've been observing so far and throughout our development program and it's really aligned with our intention, which is to develop an incremental body of evidence that arrives at a really efficient delivery framework for hopefully labeling discussions and commercialization of the product.

到目前為止，我們在整個研發過程中觀察到的情況讓我深受鼓舞，這與我們的目標非常契合，即逐步積累證據，最終建立一個真正高效的交付框架，以便進行標籤討論和產品商業化。

Dear speakers, there are no further questions for today. This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

各位發言者，今天沒有其他問題了。今天的電話會議到此結束。感謝您的參與。現在你們都可以斷開連結了。祝你今天過得愉快。