Mind Medicine (MindMed) Inc (MNMD) 2025 Q1 法說會逐字稿

Good morning and welcome to the MindMed's first quarter 2025, Financial Results and Corporate Update webcast.(Operator Instructions).

早安，歡迎收聽 MindMed 2025 年第一季財務表現及公司更新網路廣播。 （操作員指示）。

I would like to introduce Stephanie Fagan, Chief Corporate Affairs officer of MindMed. Please go ahead.

我想介紹 MindMed 首席企業事務長 Stephanie Fagan。請繼續。

Thank you, operator, and good morning, everyone.

謝謝接線員，大家早安。

Thank you for joining us today for a discussion of MindMed's first quarter 2025, business highlights and financial results. Leading the call today will be Robert Barrow, our Chief Executive Officer.

感謝您今天加入我們討論 MindMed 2025 年第一季的業務亮點和財務業績。今天的電話會議主持人將是我們的執行長羅伯特·巴羅 (Robert Barrow)。

He will be joined by Matt Willey, our Chief Commercial Officer and Doctor Daniel Karlin, our Chief Medical Officer.

他將與我們的首席商務官 Matt Willey 和首席醫療官 Daniel Karlin 醫生一同出席。

After our prepared remarks, we will open the call for Q&A.

在我們準備好發言之後，我們將開始問答環節。

And 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.

今天電話會議的錄音和網路直播重播也將在線上提供，詳情請參閱本次電話會議的新聞稿公告。

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 runway and future expectations, plans, partnerships, and prospects.

在今天的電話會議中，我們將做出某些前瞻性陳述，包括但不限於有關我們候選產品的潛在安全性、有效性、監管和臨床進展、我們預期的現金流量以及未來預期、計劃、合作夥伴關係和前景的陳述。

These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes.

這些聲明受各種風險的影響，例如市場條件的變化以及與研發和監管審批流程相關的困難。

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 10K and our Form 10Q being filed today.

這些和其他風險因素在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進行了描述，包括我們今天提交的 10K 表年度報告和 10Q 表年度報告。

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 the applicable Canadian securities regulators or other significant events occurring outside of MindMed's normal course of business.

前瞻性陳述是基於管理層在陳述之日的假設、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所描述的風險和不確定性的未發生，或在 MindMed 正常業務範圍之外發生的其他重大事件。

You are cautioned not to place undue reliance on these forward-looking statements which are made as of today, May 8, 2025.

請注意不要過度依賴截至 2025 年 5 月 8 日所做的這些前瞻性陳述。

MindMed 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.

MindMed 不承擔更新此類聲明的任何義務，即使管理層的觀點發生變化，除非法律要求。說完這些，讓我把電話轉給羅布。

Thank you, Stephanie and everyone for joining our call today.

感謝史蒂芬妮和大家今天參加我們的電話會議。

Before we dive into our business updates and financial results, I want to acknowledge that May is Mental Health Awareness Month, something that is deeply important to us.

在我們深入了解業務更新和財務結果之前，我想承認五月是心理健康意識月，這對我們來說非常重要。

This is a time to recognize the millions of individuals around the world who are affected by mental health disorders, including generalized anxiety disorder or GAD and major depressive disorder, or MDD.

現在是認識到全世界數百萬受到精神健康障礙影響的個人的時候了，其中包括廣泛性焦慮症（GAD）和重度憂鬱症（MDD）。

At MindMed, our mission to transform the treatment of brain health disorders is closely aligned with the goals of Mental Health Awareness Month.

在 MindMed，我們改變大腦健康障礙治療方法的使命與心理健康意識月的目標密切相關。

This month, we stand with others working to address the significant challenges faced by those living with mental health conditions.

本月，我們與其他人站在一起，共同努力解決精神健康問題患者所面臨的重大挑戰。

As we continue to advance our clinical programs and deliver on key milestones, we also recognize the vital contributions of the broader community.

隨著我們不斷推進臨床計畫並實現關鍵里程碑，我們也認識到更廣泛社區的重要貢獻。

From the investigators leading our trials to the patients who participate, and the many advocates striving awareness and progress, each plays a crucial role in shaping a future where mental health is treated with the urgency and innovation it deserves.

從領導我們試驗的研究人員到參與試驗的患者，以及眾多努力提高認識和進步的倡導者，每個人都在塑造未來發揮著至關重要的作用，在未來，心理健康將得到應有的緊迫性和創新性的治療。

The mental health crisis underscores the need for novel therapies like MM120, our lead program for the potential treatment of GAD and NTD.

精神健康危機凸顯了對新型療法的需求，例如 MM120，這是我們針對 GAD 和 NTD 的潛在治療的主要項目。

Three of our pivotal phase 3 trials evaluating M120 ODTN patients with GAD and MDD Voyage, panorama, and Emerge are now actively enrolling, and we're seeing strong engagement from clinical sites and patients as momentum continues to build.

我們評估患有 GAD 和 MDD 的 M120 ODTN 患者的三項關鍵性 3 期試驗 Voyage、panorama 和 Emerge 目前正在積極招募，隨著勢頭的不斷增強，我們看到臨床站點和患者的積極參與。

We're on track to report topline data from Voyage in the first half of 2026, with panorama and a merge to follow in the second half.

我們預計在 2026 年上半年報告 Voyage 的頂線數據，並在下半年報告全景和合併數據。

With breakthrough therapy designation for MM120 (ODT) and GAD, a well-defined regulatory strategy, a consistent execution across our programs, we are delivering against our strategic objectives.

憑藉 MM120（ODT）和 GAD 的突破性療法認定、明確的監管策略以及各個項目的一致執行，我們正在實現我們的策略目標。

We believe MM120 ODT has the potential to become a differentiated, best in class treatment for GAD and MDD, addressing a significant unmet need for over $50 million people in the US alone.

我們相信 MM120 ODT 有潛力成為一種差異化、一流的 GAD 和 MDD 治療方法，僅在美國就能滿足超過 5000 萬人的未滿足需求。

Our focus remains on driving this innovation forward and positioning the company for long term value creation as we move towards commercialization.

我們的重點仍然是推動這項創新，並在走向商業化的過程中為公司創造長期價值。

With 3 of our pivotal trials now underway and enrollment progressing, we continue to generate evidence to support MM120 ODT's potential and highlight its tremendous commercial opportunity.

隨著我們三項關鍵試驗的進行和招募工作的推進，我們將繼續提供證據來支持 MM120 ODT 的潛力並強調其巨大的商業機會。

To lead this effort, we recently welcomed our new Chief Commercial Officer, Matt Wili to our team.

為了領導這項工作，我們最近歡迎新任商務長 Matt Wili 加入我們的團隊。

Matt is uniquely positioned to lead our commercial strategy during this critical growth phase.

在這個關鍵的成長階段，馬特具有獨特的優勢來領導我們的商業策略。

It has more than 25 years of experience, having successfully driven the commercialization of innovative therapies with a focus on CNS and psychiatry.

該公司擁有超過 25 年的經驗，成功推動了以中樞神經系統和精神病學為重點的創新療法的商業化。

He has guided products from development to market launch and accelerated the growth of inline marketed therapies.

他指導產品從開發到上市的整個過程，並加速了線上市場療法的發展。

His expertise and insights bring tremendous value to our team, and we couldn't be more excited about having him on board at such a pivotal time.

他的專業知識和見解為我們的團隊帶來了巨大的價值，我們非常高興他在如此關鍵的時刻加入我們。

With that I'd like to turn the call over to Matt so we can formally introduce himself. Matt.

說完這些，我想把電話轉給馬特，好讓我們可以正式介紹自己。馬特。

Good morning everyone and thank you, Rob, for the introduction. It's an exciting time to be at Mind Me. I joined this team because what we're doing here isn't just incremental, but something potentially transformational.

大家早安，謝謝 Rob 的介紹。現在加入 Mind Me 是一件令人興奮的事情。我加入這個團隊是因為我們在這裡所做的事情不僅僅是漸進的，而且具有潛在的變革性。

The data from our phase 2b trial of MM120 and GAD is among the most compelling I've seen in neuroscience, and the disciplined approach behind it speaks volumes about this company's caliber.

我們對 MM120 和 GAD 進行的 2b 期試驗的數據是我在神經科學領域見過的最引人注目的數據之一，其背後的嚴謹方法充分說明了這家公司的實力。

Now that I'm inside the organization, my conviction is even stronger. MM120 could redefine the treatment paradigm for GAD and MDD, and we're moving with urgency to build a commercial engine that matches the ambition and rigor of our science.

現在我加入這個組織後，我的信念更加堅定了。MM120 可以重新定義 GAD 和 MDD 的治療模式，我們正在緊急建造一個與我們的科學抱負和嚴謹性相符的商業引擎。

Over the past 25 years, I've led commercial strategies for multiple breakthrough therapies in psychiatry and CNS.

在過去的 25 年裡，我領導了精神病學和中樞神經系統領域多項突破性療法的商業策略。

Navigated complex regulatory environments and secured market access in some of the most competitive markets.

在複雜的監管環境中導航並在一些競爭最激烈的市場中獲得市場准入。

I've helped companies successfully manage critical product transitions from late stage development through launch and beyond.

我幫助公司成功管理從後期開發到發布及以後的關鍵產品轉型。

And I've built commercial organizations from the ground up that are patient focused, science driven, and launch ready.

我白手起家創立了以病人為中心、以科學為導向、隨時準備推出的商業組織。

What we're building here at MindMed is no exception. I believe that we're laying the foundation for both a successful launch and for lasting leadership in this space.

我們在 MindMed 所建構的一切也不例外。我相信我們正在為成功推出和在該領域的持久領導地位奠定基礎。

Every element of our strategy is intended to reflect the same high standards and determination the company has shown in clinical development.

我們策略的每一個要素都旨在反映公司在臨床開發中表現出的同樣高標準和決心。

Thank you again to Rob and to the rest of the team for their warm welcome.

再次感謝 Rob 和團隊其他成員的熱情歡迎。

I'm honored to be here and looking forward to what we can achieve together.

我很榮幸來到這裡並期待我們能夠共同取得成就。

And I'm excited to share more about our progress in the months ahead.

我很高興能在未來幾個月分享更多我們的進展。

I'll now turn the call over to Daniel, for an update on our clinical programs.

現在我將把電話轉給丹尼爾，以了解我們的臨床計畫的最新進展。

Thank you, Matt. It's great to have you with us. As Rob mentioned, we have dose participants in three of our pivotal phase 3 clinical studies Voyage and panorama, evaluating MM120, ODT and GAD and [aerge] evaluating MM120 (ODT) in MDD.

謝謝你，馬特。很高興您能加入我們。正如 Rob 所提到的，我們在三個關鍵的 3 期臨床研究 Voyage 和 Panorama 中都有劑量參與者，評估 MM120、ODT 和 GAD，並 [aerge] 評估 MM120（ODT）在 MDD 中的作用。

Starting with Voyage and Panorama, we remain highly encouraged by the pace of enrollment. Patients and providers continue to show enthusiasm and high levels of engagement.

從 Voyage 和 Panorama 開始，我們對招生速度感到非常鼓舞。患者和提供者繼續表現出熱情和高度參與。

We remain on track and continue to expect topline readouts from Voyage in the first half of 2026 and panorama in the second half of 2026.

我們將繼續按照計劃進行，並繼續預計 2026 年上半年 Voyage 的頂線讀數和 2026 年下半年的全景讀數。

As a reminder, each study consists of two parts. Part a 12-week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of MM120 versus placebo, and Part B, a 40 week extension period with opportunities for open label treatment designed to provide important long term data on the durability and response patterns with MM120.

提醒一下，每項研究由兩部分組成。第一部分為為期 12 週的隨機雙盲安慰劑對照平行組研究，評估 MM120 與安慰劑相比的療效和安全性；第二部分為為期 40 週的延長期，提供開放標籤治療的機會，旨在提供有關 MM120 的持久性和反應模式的重要長期數據。

In Voyage, we expect to enroll approximately 200 participants who will be randomized 1 to 1 to receive MM120 ODT 100 mcg or placebo, while in panorama we expect to enroll approximately 250 participants who will be randomized 2:1:2 to receive MM120 ODT 100 mcg 50 mcg, or placebo.

在 Voyage 研究中，我們預計將招募約 200 名參與者，他們將以 1 比 1 的比例隨機分配接受 MM120 ODT 100 mcg 或安慰劑，而在全景研究中，我們預計將招募約 250 名參與者，他們將按 2:1:2 的比例隨機分配接受安慰劑 120 ODT 50 mcg。

In both design and execution, we closely modeled our phase 3 GAD studies after our successful phase 2B study of MM120 and GAD. In both Voyage and panorama, the primary endpoint is to change from baseline to week 12 in the HAMA scale, which was the outcome measure used for the approval of currently available GAD therapies.

在設計和執行方面，我們都嚴格模仿了 MM120 和 GAD 成功的 2B 期研究，對我們的 3 期 GAD 研究進行了建模。在 Voyage 和全景研究中，主要終點是 HAMA 量表從基線到第 12 週的變化，這是用於批准目前可用的 GAD 療法的結果測量標準。

We designed these trials to have 90% power to detect a 5-point improvement over placebo based on certain statistical assumptions, whereas in the phase 2B trial, we observed an almost 8 point improvement for MM120 over placebo at week 12. To ensure our actual statistical power is maintained, we are using an adaptive design in our GAD phase 3 studies, which includes an in term blinded sample size reestimation that allows for increased enrollment of up to 50% in each trial if necessary.

我們設計這些試驗的目的是，基於某些統計假設，以 90% 的功效檢測出比安慰劑有 5 分的改善，而在 2B 期試驗中，我們觀察到第 12 週 MM120 比安慰劑有近 8 分的改善。為了確保維持我們的實際統計能力，我們在 GAD 第 3 階段研究中採用了自適應設計，其中包括對盲樣本量的重新估計，允許在必要時在每次試驗中增加高達 50% 的入組率。

This approach helps to adjust for any unexpected variability in nuisance parameters, specifically dropout rates and pooled variants of handmade response, maintaining statistical power, and enhancing the interpretability of our results if needed.

這種方法有助於調整幹擾參數中的任何意外變化，特別是退出率和手動響應的匯總變量，保持統計能力，並在需要時增強結果的可解釋性。

We've kept our inclusion and exclusion criteria consistent with our successful phase 2b study of MM120 and GAD incorporating exclusion criteria around the recency and total use of psychedelics to ensure a representative sample is recruited.

我們的納入和排除標準與 MM120 和 GAD 的成功 2b 期研究保持一致，結合迷幻藥的近期使用情況和總使用情況作為排除標準，以確保招募到具有代表性的樣本。

We also conduct comprehensive safety assessments and labs before and after the administration of MM120 and ensure the collection of all adverse events.

我們還在使用 MM120 之前和之後進行全面的安全評估和實驗室檢查，並確保收集所有不良事件。

Turning to our MDD program with MM120, we are thrilled to have dosed our first participants in the pivotal phase 3 emerged trial and are encouraged by early enrollment trends.

談到我們的 MM120 MDD 計劃，我們很高興在關鍵的 3 期臨床試驗中為首批參與者進行了給藥，並對早期招募趨勢感到鼓舞。

Just like our GAD program, our MDD program will consist of two pivotal clinical studies. Our first study, a merge, will be comprised of two parts. Part a 12-week randomized double blind placebo-controlled parallel group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo. And Part B, a 40-week extension period during which participants will be eligible for open label treatment with MM120 subject to meeting eligibility requirements.

與我們的 GAD 計畫一樣，我們的 MDD 計畫將包括兩項關鍵的臨床研究。我們的第一項研究，合併，將由兩部分組成。第 12 週隨機雙盲安慰劑對照平行組研究，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 週的延長期，在此期間，參與者將有資格接受 MM120 的開放標籤治療，但須符合資格要求。

It emerged we planned to enroll at least 140 participants with a primary diagnosis of MDD, randomized 1 to 1 to receive MM120, ODT 100 mcg, or placebo.

我們計劃招募至少 140 名主要診斷為 MDD 的參與者，以 1 比 1 的比例隨機分配接受 MM120、ODT 100 mcg 或安慰劑。

The primary endpoint in a merge is the change from baseline in Montgomery as for depression rating scale, or Madris at week 6 between the groups. We continue to anticipate top line data from a merge in the second half of 2026.

合併的主要終點是蒙哥馬利憂鬱評定量表與基線的變化，或第 6 週組間馬德里斯的變化。我們繼續預期 2026 年下半年合併後將產生營收資料。

Overall, we're excited to have 3 pivotal trials actively recruiting with ALL3 readouts anticipated next year. With that, I will turn the call over to Rob to discuss our first quarter financial results. Rob.

總體而言，我們很高興有 3 項關鍵試驗正在積極招募，預計明年將公佈 ALL3 的讀數。說完這些，我將把電話轉給 Rob，討論我們的第一季財務表現。搶。

Thanks, Daniel.

謝謝，丹尼爾。

According to our financial results, the quarter ended March 31, 2025. We ended the quarter with cash equivalents, and investments totaling $245.5 million.

根據我們的財務結果，該季度截至 2025 年 3 月 31 日。本季末，我們的現金等價物和投資總額為 2.455 億美元。

We believe that our cash equivalents and investments as of March 31, 2025 will be sufficient to fund our operations into 2027.

我們相信，截至 2025 年 3 月 31 日的現金等價物和投資將足以資助我們到 2027 年的營運。

Overall, based on our current operating plan and anticipated R&D milestones, we expect our cash runway to extend at least 12 months beyond our first phase 3 topline data readout for MM120 ODT and GAD.

總體而言，根據我們目前的營運計劃和預期的研發里程碑，我們預計我們的現金流量將在 MM120 ODT 和 GAD 的第一階段 3 期頂線資料讀數之後延長至少 12 個月。

In April, we amended our loan agreement with K2 Health Ventures to provide greater financial flexibility and optionality.

4 月，我們修改了與 K2 Health Ventures 的貸款協議，以提供更大的財務靈活性和可選性。

The revised facility provides us with excess of up to $120 million based on the achievement of certain milestones and extends the interest only period to at least May 1, 2027.

修訂後的貸款將根據某些里程碑的實現為我們提供高達 1.2 億美元的超額貸款，並將僅付利息的期限延長至至少 2027 年 5 月 1 日。

The company received approximately $17.8 million in net cash at closing after refinancing in full all term loans outstanding under the original agreement and the payment of fees and expenses in connection with the amendment and the refinancing of the existing term loans.

在對原協議項下所有未償還的定期貸款進行全額再融資，並支付與修改和再融資現有定期貸款有關的費用和開支後，該公司在交易結束時獲得了約 1,780 萬美元的淨現金。

Research and development expenses were $23.4 million for the three months ended March 31, 2025, compared to $11.7 million for the three months ended March 31, 2024, an increase of $11.7 million.

截至 2025 年 3 月 31 日的三個月，研發費用為 2,340 萬美元，而截至 2024 年 3 月 31 日的三個月為 1,170 萬美元，增加了 1,170 萬美元。

The increase was primarily due to $9.4 million in expenses related to our MM120 program, an increase of $2.4 million in internal personnel costs as a result of increasing research and development capacities, and an increase of $0.1 million in preclinical and other program expenses partially offset by a decrease of $0.2 million in 402 program expenses.

增加的主要原因是與我們的 MM120 項目相關的費用增加了 940 萬美元，由於研發能力的提高導致內部人員成本增加了 240 萬美元，臨床前和其他項目費用增加了 10 萬美元，但 402 項目費用減少了 20 萬美元，部分抵消了這一增加。

We anticipate R&D expenses will continue to ramp up in 2025, due to the cost associated with running three pivotal phase 3 studies.

我們預計，由於進行三項關鍵的 3 期研究的相關成本，2025 年研發費用將持續增加。

General and administrative expenses were $8.8 million for the three months ended March 31, 2025, compared to $10.5 million for the three months ended March 31, 2024, a decrease of $1.7 million.

截至 2025 年 3 月 31 日的三個月，一般及行政費用為 880 萬美元，而截至 2024 年 3 月 31 日的三個月，一般及行政費用為 1050 萬美元，減少了 170 萬美元。

The decrease was primarily attributable to stock-based compensation expense.

下降主要歸因於股票薪酬費用。

To close, this is an exciting and pivotal time for MindMed.

總而言之，對於 MindMed 來說，這是一個令人興奮的關鍵時刻。

Our three phase 3 trials of MM120 ODT are active, and the enthusiasm from our clinical site speaks volumes about the need for and promise of MM120.

我們對 MM120 ODT 的三項 3 期試驗正在進行中，我們臨床站點的熱情充分說明了 MM120 的必要性和前景。

We are energized, aligned, and confident in where we're headed.

我們充滿活力、步調一致、對未來充滿信心。

With breakthrough therapy designation for MM120 ODP and GAD, a clear regulatory strategy, and consistent execution across our pipeline, we are delivering on our mission and driving meaningful value for patients, physicians, and shareholders alike.

憑藉 MM120 ODP 和 GAD 的突破性治療指定、明確的監管策略以及整個產品線的一致執行，我們正在履行我們的使命並為患者、醫生和股東創造有意義的價值。

Thank you for being with us on the call today and the team and I are now happy to answer your questions.

感謝您今天參加我們的電話會議，我和我的團隊現在很高興回答您的問題。

(Operator Instructions).

（操作員指令）。

And our first question comes from the line of Marc Goodman with Leerink Partners.

我們的第一個問題來自 Leerink Partners 的 Marc Goodman。

Hi, good morning.

嗨，早安。

Thank you for taking our question. We have a question regarding the MNMD trial. Would you please remind us again whether you still need to assess the low dose of 5 mcg, in this trial or maybe in the second phase trial that you, you're planning to start. And, regarding the therapeutic effective dose, is it fair to assume that the same therapeutic dose in GAD, which is a 100 mcg will also be in MDD effective in MDD, and, that's it for us.

感謝您回答我們的問題。我們有一個關於 MNMD 試驗的問題。請您再次提醒我們，在本次試驗中或在您計劃開始的第二階段試驗中，您是否仍需要評估 5 mcg 的低劑量。並且，關於治療有效劑量，是否可以公平地假設，在 GAD 中相同的治療劑量，即 100 mcg，在 MDD 中也有效，對我們來說就是這樣。

Thank you.

謝謝。

Perfect, thanks so much, Basma. I'll turn it over to Dan, to that one.

太好了，非常感謝，巴斯瑪。我將把它交給丹。

Yeah, thanks so much for the question. So as you noted in our second GAD study, we're using that 50 mcg intermediate blinding control dose, and in our disclosed MDD study, we are not using an intermediate dose, we're using a two-arm study, so. Micrograms versus placebo as we've done in our first GAD study, but it's reasonable to think that at some point in the MDD development program as we as we move into any additional required studies that we might use that same 50 mcg intermediate blinding control arm. So while we haven't disclosed the plan to do so, it's not unreasonable to think that at some point in the MDD program we would do a similar blinding control as we've done in GAD. With regard to the therapeutic dose that we would bring forward in MDD, what we have disclosed is that we'll be using that same 100 mcg active arm, which we have reason to believe from our GAD results in phase 2B has high efficacy against depression cluster symptoms. So yeah, that's what we're using in our disclosed program and reasonable to think that's what we'll continue to use moving forward, the 10 mcg arm.

是的，非常感謝您的提問。因此，正如您在我們的第二次 GAD 研究中所指出的，我們使用 50 mcg 中間盲法對照劑量，而在我們披露的 MDD 研究中，我們沒有使用中間劑量，而是使用了雙臂研究，所以。正如我們在第一次 GAD 研究中所做的那樣，微克與安慰劑進行了對比，但有理由認為，在 MDD 發展計劃的某個階段，當我們進入任何其他必要的研究時，我們可能會使用相同的 50 微克中間盲法對照組。因此，雖然我們尚未披露此計劃，但認為在 MDD 計劃的某個階段我們會進行與 GAD 中類似的盲法控制並非不合理。關於我們將在 MDD 中提出的治療劑量，我們已經披露的是，我們將使用相同的 100 mcg 活性劑量，從我們 2B 期 GAD 的結果來看，我們有理由相信該劑量對抑鬱症叢集症狀具有很高的療效。是的，這就是我們在披露的計劃中所使用的，並且有理由認為，這就是我們將繼續使用的，即 10 mcg 組。

Thank you very much. You're very helpful.

非常感謝。你很有幫助。

Thank you.

謝謝。

And our next question comes from the line of Brian Abrams with RBC Capital Markets.

我們的下一個問題來自加拿大皇家銀行資本市場的 Brian Abrams。

Hey guys, thanks for taking our questions. Congrats on the progress and, Matt, welcome to the team. Just curious as you know the trials enrollment, really gets gets going, if there are any kind of learnings that you're taking away initially from GAD epidemiology or or treatment patterns, disease recognition, provider engagement, that sort of thing. And any surprises so far and kind of how that's shaping your overall commercial approach, and then I guess I'm also curious then kind of following up on the prior question on how the like your latest views on how the low dose might might play in if you're seeing any kind of.

嘿夥計們，感謝你們回答我們的問題。恭喜你的進步，馬特，歡迎加入團隊。我很好奇，正如您所知，試驗招募確實已經開始了，您是否從 GAD 流行病學或治療模式、疾病識別、提供者參與等方面獲得了一些初步的經驗。到目前為止有什麼驚喜嗎？以及這對您的整體商業方法有何影響？然後我想我也很好奇，然後繼續前面的問題，即您對低劑量可能發揮什麼作用的最新看法，如果您看到任何影響。

Evolution in regulatory perspectives and and what what you might be looking for out of the 50 mcg dose for either indication do you does it need to look less efficacious than than the 100 or or kind of what happens if the if if you show no efficacy there or comparable efficacy. Thanks.

監管視角的演變以及您可能希望從 50 mcg 劑量中尋找什麼，對於任何一種適應症，它的有效性是否需要看起來低於 100 或如果未顯示任何療效或具有相當的療效，會發生什麼情況。謝謝。

Yeah, thank, thanks so much for the question, Brian. Take them in in reverse order and I stand to answer the second one. I think with regard to the 50 mcg dose again, there's been a lot of discussion about.

是的，非常感謝你的提問，布萊恩。如果按相反的順序回答，我願意回答第二個問題。我認為關於 50 微克劑量的問題已經有很多討論。

Various controls used in across, drugs that are under development in in this, in this category, and we made the decision to include a 50 mcg dose group to answer some of those questions and some of the methodological asks from FDA.

在這個類別中，針對正在開發的藥物使用了各種控制措施，我們決定納入 50 mcg 劑量組來回答其中的一些問題以及 FDA 的一些方法論要求。

It is really important for everyone to understand that dose level tells us nothing about the performance of the clinical dose of interest. As with any program, we are looking at a dose of drug, in our case 100 mcg of MM120 versus placebo. And while we've included the 50 mcg dose level, it's there so that patients coming into the trial will not be able to draw a degree of certainty between feeling something on the day of dosing.

每個人都必須明白，劑量水平並不能告訴我們感興趣的臨床劑量的表現。與任何項目一樣，我們正在研究藥物劑量，在我們的例子中是 100 微克 MM120 與安慰劑。雖然我們採用了 50 微克的劑量水平，但這樣做是為了讓參加試驗的患者無法確定服藥當天是否會有感覺。

And what expectancy they might have coming into the study that wouldn't bias the ultimate clinical outcome assessments. So while we are measuring the response and the activity in the 50 mcg dose group, because it can provide no logical or statistical learnings about the performance of 100 mcg versus placebo, it's really irrelevant to the findings from the study, both statistically and what we interpret clinically.

以及他們對研究抱持什麼樣的期望，以不影響最終的臨床結果評估。因此，雖然我們正在測量 50 mcg 劑量組的反應和活動，但由於它無法提供關於 100 mcg 與安慰劑相比表現的邏輯或統計學習，因此它與研究結果無關，無論是統計學上還是臨床解釋。

Now, there are a number of scenarios that could play out and we're certainly very keen on understanding those, but we, we've already looked really the first and only study in the class looked comprehensively at a dose response and we've established the minimum clinically effective dose out at at several months after a single administration. So we feel incredibly confident in the dose selection and the justification for that dose and thinking that It would be somewhat illogical to then throw away the evidence we've generated so far, which is so compelling in a study just where we have a second methodological control. So we're just simply focused on the 100 mcg versus placebo and and include that second dose level again just to aid in. Sort of confounding of patients that they may not be able to know with certainty because they felt something on the day of dosing that they got a real clinically active dose of drug. Turn over to Dan, I answer the other part of the question.

現在，可能會出現多種情況，我們當然非常熱衷於了解這些情況，但我們已經真正研究了同類研究中第一個也是唯一一個全面研究劑量反應的研究，並且我們已經確定了單次給藥後幾個月的最低臨床有效劑量。因此，我們對劑量選擇和劑量的合理性非常有信心，並認為丟棄我們迄今為止產生的證據有點不合邏輯，這在我們擁有第二個方法控制的研究中是如此令人信服。因此，我們只是簡單地關注 100 微克與安慰劑的對比，並再次加入第二個劑量水平以提供幫助。患者可能不太確定，因為他們在服藥當天感覺到了某種東西，所以他們可能無法確定自己是否服用了真正具有臨床活性的藥物劑量。交給丹，我回答問題的另一部分。

Yeah, Brian, it's a great question about about GAD and and learnings and change over time, for us, of course, having run through the phase to be in GAD, which was not something most have done, right? There haven't been GAD approvals in 20 years. And so to be running sponsored research in GAD, we've, of course, learned a lot about how to find patients, how to recruit them, how to get the right folks into the study. So for us and the sites we work with, of course learnings from phase two that we've brought forward into phase 3 here, I think there's a broader perspective on that. You mentioned the epidemiology of the illness. And what we've found just in the time since we've started working on GAD is that there is clearly broader awareness and attention to the disorder just in the time that we've been working in it. So, over time as more people see anxiety as an issue for the, for themselves, as something that's worth seeking clinical attention, that's worth seeking out clinical trials, I think we're only benefiting from the pendulums. Back in the direction of GAD from where it's been sort of pinned over the last 20 years on MDD where where people are more and more willing to talk about and think about anxiety as a source of distress in their lives. So all of that, the change both on our level and on really what we're seeing a sort of systematic societal level is all working in favor of both the disorder as a target of clinical research and ultimately if approved as a commercial target.

是的，布萊恩，這是一個很好的問題，關於廣泛性焦慮症 (GAD) 以及隨著時間的推移而發生的學習和變化，對於我們來說，當然，我們已經經歷了處於廣泛性焦慮症 (GAD) 的階段，這不是大多數人都會做的事情，對吧？20 年來，GAD 從未獲得批准。因此，為了進行 GAD 贊助研究，我們當然學到了很多關於如何尋找患者、如何招募患者以及如何讓合適的人參與研究的知識。因此，對於我們以及與我們合作的網站來說，當然，我們將第二階段的經驗帶入了第三階段，我認為這會帶來更廣闊的視角。您提到了這種疾病的流行病學。自從我們開始研究廣泛性焦慮症以來，我們發現人們對這種疾病的認識和關注度明顯提高了。因此，隨著時間的推移，越來越多的人將焦慮視為自己的問題，認為焦慮值得尋求臨床關注，值得尋求臨床試驗，我認為我們只會從鐘擺中受益。回到 GAD 的方向，過去 20 年來，GAD 一直被歸咎於 MDD，人們越來越願意談論和思考焦慮是他們生活中痛苦的根源。因此，我們所看到的系統性社會層面以及我們自身層面的變化都有利於將疾病作為臨床研究的目標，並最終批准將其作為商業目標。

Super helpful thanks Daniel thanks Rob.

非常有幫助，謝謝 Daniel，謝謝 Rob。

Thank you.

謝謝。

And our next question comes from the line of Gavin Clark-Gartner with Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Gavin Clark-Gartner。

Hi, this is [Yasha] for Gavin. Thanks for taking our questions. Just a more general one from us given the recent change up in FD leadership, could you maybe speak to how engagement has been going with the agency over the course of the year?

嗨，我是 Gavin 的 [Yasha]。感謝您回答我們的問題。鑑於 FD 領導層最近的變動，我們只想提一個更籠統的問題，您能否談談今年以來與該機構的合作情況如何？

Thank you.

謝謝。

Yeah, thanks so much for the question. Yesha. We obviously are very much aware and and there been a lot of headlines about changes at HHS and and at FDA.

是的，非常感謝您的提問。耶莎。我們顯然非常清楚，並且有很多關於 HHS 和 FDA 變化的頭條新聞。

So far our engagement has stayed strong. FDA has been an incredible partner throughout our development program and that's all I continued. So we've continued to have strong engagement and, timely responses on any sort of. Correspondence we have with the agency, so we're not seeing any direct impact at this point they're really encouraged by the dialogue we we continue to have.

到目前為止，我們的合作一直很牢固。在我們的整個開發計畫中，FDA 一直是一位非常出色的合作夥伴，我將繼續這樣做。因此，我們繼續密切參與，並及時回應各種問題。我們與該機構保持聯繫，因此我們目前沒有看到任何直接影響，他們確實對我們繼續進行的對話感到鼓舞。

Thanks so much.

非常感謝。

Thank you. And our next question comes from the line of Charles Duncan with Cantor.

謝謝。我們的下一個問題來自 Cantor 的 Charles Duncan。

Hi, good morning. This is [Elaine Kim] on for Charles.

嗨，早安。我是 [Elaine Kim]，為查爾斯報道。

Thank you for taking our questions. It's great to hear that enrollment is on track for the GAD and NDD trials, but what are steps that you're taking to limit, enrolling professional patients in maintaining the same robust effect size that you've seen in the phase 2D trial, and I have a quick follow up.

感謝您回答我們的問題。很高興聽到 GAD 和 NDD 試驗的招募工作進展順利，但您採取了哪些措施來限制專業患者的招募，以保持您在 2D 期試驗中看到的同樣強勁的效果大小，我有一個快速的跟進。

Yeah, at the highest level, everything about how we've designed and are executing the phase 3 program is consistent with what we did in in phase 2. So, obviously we, as we progress through development we have incremental learnings to make ourselves more efficient and make sure we're getting the right patients into these studies, but I'll turn it over to Daniel to elaborate a little bit On patient selection.

是的，從最高層面來看，我們設計和執行第三階段計畫的一切都與我們在第二階段所做的一致。因此，顯然，隨著我們不斷取得進展，我們會不斷學習，以提高效率，並確保我們讓合適的患者參與這些研究，但我將把時間交給丹尼爾來詳細說明患者選擇。

Yeah, so from a patient selection perspective and an enrollment perspective, we have several confirmatory steps as we enroll folks. So we look at records from outside treaters. We have a confirmatory interview called the Safer that's done by a third party raider. So each step through the screening process and ultimately leading up to enrollment is really oriented around ensuring. A strict adherence to protocol and inclusion exclusion criteria and screening out folks who might be enrolling for reasons other than trial participation as it's intended to be. So we're confident in our sites. We have close relationships with our sites and ultimately it really does come down to the intersection between high quality sites who are who are in it to get the right patients and good external confirmation to ensure that. That the folks we get are the folks we intended to.

是的，從患者選擇和招募的角度來看，我們在招募患者時有幾個確認步驟。因此我們查看了外部治療師的記錄。我們有一個確認採訪，稱為“Safer”，是由第三方襲擊者進行的。因此，篩選過程的每個步驟以及最終入學的過程實際上都以確保為中心。嚴格遵守協議和納入排除標準，並篩選出可能因非試驗參與原因而入組的人。所以我們對我們的網站充滿信心。我們與我們的站點保持著密切的關係，最終它確實歸結為高品質站點之間的交集，這些站點可以獲得合適的患者，並透過良好的外部確認來確保這一點。我們得到的人正是我們想要得到的人。

Okay, that's really helpful. And, while the risk for suicidality is not as high as it is in GAD and MDD versus, like treatment resistant depression, but what are steps that you are taking to monitor and prevent the safety risks?

好的，這確實很有幫助。而且，雖然與難治性憂鬱症相比，自殺風險不如 GAD 和 MDD 高，但您採取了哪些措施來監測和預防安全風險？

Yeah, from enrollment through trial completion, we're of course very attuned to suicidality in any treatment in psychiatry and in truth, any treatment in medicine, there's always the risk for suicidal thinking and even suicidal behavior, and of course that's something that's been appropriately paid attention to in our field. From screening on, we conduct the Industry standard Columbia suicide severity rating scale CSSRS, to ensure that patients we enroll are safe to be enrolled, that anyone who is actively suicidal should be getting care that's not, research-based care that's true clinical care, so we're able to refer people back into the clinical care system if when they present they're too ill to participate. And then throughout the trial, we continue to monitor both through, of course, Adverse event reporting, but also through serial C-SSRSs and clinical assessments to ensure that if there is a suicide signal that we're able to detect it and respond appropriately. Of course in our phase two, we did not see a suicide signal which we were. Really, glad to see, of course, for the treatment and for the for the disease state population. So we'll just continue to do what we've done and make sure we're enrolling appropriate patients and that we're monitoring them through the course of treatment appropriately so that both we can ensure participant safety and that we can have a good ability to report out on our safety signals at the end of the trials.

是的，從入組到試驗完成，我們當然非常關注精神病學中任何治療中的自殺傾向，事實上，任何醫學治療都存在自殺想法甚至自殺行為的風險，當然這是我們領域中得到適當關注的事情。從篩選開始，我們就採用業界標準哥倫比亞自殺嚴重程度評定量表 CSSRS，以確保我們招募的患者可以安全入組，任何有自殺傾向的人都應該得到真正的臨床護理，而不是基於研究的護理，因此，如果患者病情太重而無法參加治療，我們可以將他們轉回臨床護理系統。在整個試驗過程中，我們將繼續監測，當然，透過不良事件報告，也透過連續的 C-SSRS 和臨床評估，以確保如果有自殺訊號，我們能夠檢測到它並做出適當的反應。當然，在第二階段，我們並沒有看到自殺訊號。真的，很高興看到，當然，對於治療和對於患病人群來說。因此，我們將繼續做我們已經做的事情，確保我們招募合適的患者，並在整個治療過程中對他們進行適當的監測，這樣我們既可以確保參與者的安全，又可以在試驗結束時很好地報告我們的安全信號。

Very helpful answers.

非常有用的答案。

Thank you.

謝謝。

Thanks.

謝謝。

Thank you, and our next question comes from the line of Joel Beatty with Baird.

謝謝，我們的下一個問題來自貝爾德的喬爾·比蒂。

Good morning. Thanks for taking our question. This is Chris on for Joel. Congrats on the progress, we're looking forward to data and some feedback from investors though is, 2025 is a little light on catalysts and I'm wondering, you know if if there's any plan to releasing any, in term data between now and and the final readouts and then just another question, quick question on 402. If you can provide any color on, the next steps, in terms of that, thanks.

早安.感謝您回答我們的問題。這是克里斯代替喬爾。恭喜取得的進展，我們期待數據和一些來自投資者的反饋，但 2025 年的催化劑有點少，我想知道，您是否知道是否有計劃從現在到最終讀數之間發布任何長期數據，然後是另一個問題，關於 402 的快速問題。如果您能提供關於下一步的詳細信息，謝謝。

Yeah, thanks so much for the question.

是的，非常感謝您的提問。

We are laser focused on executing these studies and we've in the past and continued to you know set the set the standard for the pace in which we're we're executing on them and with with the readouts coming next year we're we're incredibly eager to get these data out there as quickly as possible. We do have a blinded sample size reestimation that is going to occur, although we haven't provided any guidance around whether or or or if or when we would announce any findings from that analysis and beyond that we certainly don't have an anticipation that we would be analyzing or releasing any unblinded data that would be informative about the treatment effects over the course of this year so. We're, like I said, focused on getting the data as quickly as possible and getting the highest quality study results. In terms of 402, we completed the phase one study. We're continuing to develop that program, and we'll be sharing some additional details at appropriate time about what comes next in that development program and and starting to think about how we can get the program progressed to the patients that have diagnosed with autism spectrum disorder.

我們正專注於執行這些研究，我們過去一直為我們執行這些研究的速度設定標準，隨著明年讀數的公佈，我們非常渴望盡快獲得這些數據。我們確實會進行盲樣本量重新估計，儘管我們尚未提供任何關於是否或何時公佈該分析結果的指導，除此之外，我們當然也不預期會分析或發布任何有關今年治療效果的非盲數據。正如我所說，我們專注於盡快獲取數據並獲得最高品質的研究結果。就402而言，我們完成了第一階段的研究。我們正在繼續開發該計劃，並將在適當的時候分享有關該計劃下一步進展的更多細節，並開始思考如何讓該計劃惠及那些被診斷患有自閉症譜系障礙的患者。

Thanks man helpful.

謝謝這位熱心人士。

Thank you. And our next question comes from the line of Rudy Lee with Chardon.

謝謝。我們的下一個問題來自 Chardon 的 Rudy Lee。

Hey, thanks for taking my question. I'm just curious about your current thoughts on the market dynamics of psychedelics, under their current environment, given the provado growth trajectory, and can you talk about your commercial planning activities moving into the second half of the year? Thanks.

嘿，謝謝你回答我的問題。我只是好奇，考慮到 provado 的成長軌跡，您對當前環境下迷幻藥市場動態的看法，您能談談您下半年的商業規劃活動嗎？謝謝。

Sure. Hi, thanks for the question, [Matt]. So first of all, the both populations for GAD and MDD are are quite large. There are significant unmet needs in both.

當然。你好，謝謝你的提問，[馬特]。首先，GAD 和 MDD 的人群都相當龐大。兩者都存在大量未滿足的需求。

So we feel really confident about how we're planning into the second half of the year and how we're going to address these unmet needs.

因此，我們對下半年的規劃以及如何解決這些未滿足的需求充滿信心。

First of all, I'll take on GAD. I mean, there's no shortage of GAD patients. It's a durable market, and even though it's been dormant for some time, what we've seen in claims data is diagnosis rates that have been pretty consistent over time. So this is a disease state that is recognizable by clinicians, the diagnosis diagnoses are made.

首先，我要挑戰一下 GAD。我的意思是，GAD 患者並不短缺。這是一個持久的市場，儘管它已經沉寂了一段時間，但我們從索賠數據中看到的是，診斷率一直相當穩定。因此，這是臨床醫生可以識別並做出診斷的疾病狀態。

There's some interesting work to do in in how we frame our market and so as we think about our positioning and messaging.

在我們如何建立市場以及思考我們的定位和資訊傳遞方面，有一些有趣的工作要做。

We intend to complete that work and roll that out in the second half of the year, and that will help the market better understand the opportunity for a drug like MM120.

我們打算在今年下半年完成這項工作並推出，這將有助於市場更好地了解 MM120 等藥物的機會。

Could just a quick follow up, what are we planning to just leverage the commercial infrastructure just to leverage on the, commercial success of the Spravado

能否快速跟進一下，我們計劃如何利用商業基礎設施來利用 Spravado 的商業成功

So it's, as we think about bravado as a surrogate, it does provide an interesting opportunity to examine their reimbursement structure, how the capacity is utilized, what capacity exists beyond bravado patients.

因此，當我們將虛張聲勢視為一種替代品時，它確實提供了一個有趣的機會來檢查他們的報銷結構、如何利用容量、以及除了虛張聲勢的患者之外還存在哪些容量。

But as a market itself, we think about GAD in in a slightly different way that the GAD patients may be in slightly different locations than where the bravado patients are there could be overlap.

但作為市場本身，我們對 GAD 的看法略有不同，GAD 患者的位置可能與虛張聲勢的患者所在的位置略有不同，可能會有重疊。

But we believe that there will be a phenotype of physician that has adopted bravado.

但我們相信，會出現一種表現出虛張聲勢的醫生表現。

That could also be adopters for MM120. And so while there we would expect that there would be some overlap in capacity utilization, there also could be additional capacity and operational opportunities beyond that.

這也可能是 MM120 的採用者。因此，雖然我們預期產能利用率會有一些重疊，但也可能會有額外的產能和營運機會。

And I'll just add one comment on top of that, which is that while we're certainly encouraged by the growth and the expansion for bravado, when we look at the relative data obviously in different populations, but the kind of response we can generate in patients, I think we and everyone we speak to are is encouraged by. The quality and both the depth and duration of effect that we can demonstrate. Sobrato is an interesting proof point, but so far in development we're incredibly confident in our data and how it would stack up against that drug and how it would position us to have have perhaps even a more expansive opportunity.

我只想補充一點，那就是，雖然我們確實對 Bravado 的增長和擴張感到鼓舞，但當我們查看不同人群中的相對數據時，我們發現患者產生了類似的反應，我認為我們和與我們交談的每個人都受到了鼓舞。我們可以展示其品質以及效果的深度和持續時間。Sobrato 是一個有趣的證明點，但到目前為止，在開發過程中，我們對我們的數據以及它與該藥物相比如何以及它如何讓我們獲得更廣泛的機會非常有信心。

Got it. That's very helpful. Thanks.

知道了。這非常有幫助。謝謝。

Thank you. And our next question comes from the line of Sumat Kulkarni with Canonccord Genuity.

謝謝。我們的下一個問題來自 Canonccord Genuity 的 Sumat Kulkarni。

Morning. Thanks for taking a question. This one is from Matt, and I know you provided some details on your rationale for joining the company, and I apologize if this has been asked because I've been hopping between calls. But what specifically in your prior experience with commercializing scheduled products might help you best on setting up MM120 for success and what are the unique challenges associated with LSD versus the other scheduled products that you might have been involved in commercializing so far?

早晨。感謝您提出問題。這是馬特打來的，我知道你提供了一些關於你加入公司的理由的細節，如果因為我一直在打電話而被問到這個問題，我深表歉意。但是，在您之前商業化預定產品的經驗中，哪些具體經驗可以幫助您最好地為 MM120 的成功做好準備，以及與迄今為止您參與商業化的其他預定產品相比，LSD 面臨哪些獨特的挑戰？

Sure, thanks, Sumat. Well, first of all, I think that, having worked on a couple products with rems, historically is going to be helpful and most specifically work on sodium oxidate when I was at Jazz which was Schedule One outside of vindication.

當然，謝謝，蘇瑪特。嗯，首先，我認為，從歷史上看，我曾與雷姆斯合作開發過幾種產品，這將會很有幫助，尤其是我在爵士隊時研究過氧化鈉，這是除辯護之外的第一附表。

There are a lot of parallels to what we're doing here. So, I do think that the REMS operations and the hub service model will be applicable here.

這與我們在這裡所做的事情有很多相似之處。所以，我確實認為 REMS 操作和中心服務模型將適用於此。

As it relates to LSD specifically, I think that there's a lot of education to come for the market.

由於它與 LSD 具體相關，我認為市場還需要大量的教育。

In how to view Both the underlying disease state scientifically and then how a drug like MM120 fits into that disease state for GAD and you know also for MDD.

如何從科學的角度看待潛在的疾病狀態，以及像 MM120 這樣的藥物如何適應 GAD 和 MDD 的疾病狀態。

So, more to come on that, but I think that reframing scientifically is a top order for us.

因此，關於這一點我們還有更多內容要討論，但我認為，科學地重新建構對我們來說是首要任務。

Got it thank you.

明白了，謝謝。

Thank you and our next question comes from the line of Jason McCarthy with Maxim Group.

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

Hey guys, this is [Michaelunoic] on the line.

嘿，大家好，我是 [Michaelunoic]。

Thank you so much for taking my questions today.

非常感謝您今天回答我的問題。

So I guess Maybe directed towards mad just thinking from a commercial perspective. Can you talk a little bit about how you think about patient targeting within MDD or GAD just given that this will require more upfront time in the clinic than other therapies, do you expect you'll be looking at patients already looking into interventional options like TMS or Sravado, patients who are on chronic drugs who may not have satisfactory efficacy or side effects? Or even patients untreated who may be discouraged from taking chronic pharma. Could you just give a bit more color on your thoughts.

所以我猜也許只是從商業角度考慮問題而導致的瘋狂。能否簡單談談您對 MDD 或 GAD 病患定位的看法？鑑於這比其他療法需要更多的臨床前期時間，您是否預計您會關注那些已經在考慮 TMS 或 Sravado 等介入療法的患者，以及那些正在服用慢性藥物但療效或副作用可能不令人滿意的患者？甚至未經治療的患者也可能不願意服用慢性藥物。您能否更詳細地闡述您的想法？

Well, we're still early days on targeting, we use claims data to identify where the patients are and certainly we'll examine a lot of different factors that will go into our targeting model. That work is ongoing. We expect to have better clarity on that in the second half of the year.

嗯，我們在目標定位方面還處於早期階段，我們使用索賠數據來確定患者在哪裡，當然，我們會研究很多不同的因素，以納入我們的目標定位模型。這項工作仍在進行中。我們預計今年下半年這個問題會更加明朗。

All right, thank you. And just one more for me, when thinking about seeking approval in both generalized anxiety and major depressive disorder, do you expect there could be some competitive benefit to having evidence in each indication individually just given the rates of comorbid anxiety and depression symptoms?

好的，謝謝。另外，我還有一個問題，當考慮尋求廣泛性焦慮症和重度憂鬱症的批准時，您是否認為，僅考慮到焦慮症和憂鬱症狀共病的發生率，在每種適應症中單獨提供證據可能會帶來一些競爭優勢？

Yeah maybe I stand to comment on just psychiatrist's perspective on this because we, we've done a lot of work with providers in the field and certainly, candy can give some more color than that.

是的，也許我只是想從精神科醫生的角度來評論這個問題，因為我們已經與該領域的服務提供者進行了大量合作，當然，糖果可以提供比這更多的色彩。

Yeah, well, I mean, we, we've made the choice clearly that from a regulatory perspective that these disorders, though massively overlapping, as you note, do exist as distinct entities, and there are certainly patients who were not in that comorbid condition, you have one or the other. In general, providers are accustomed to making a diagnosis and having a primary target for treatment, so we think that from a provider perspective, having a label that covers both disorders makes us the go to, regardless of whether someone presents in a major depressive episode or with more dominant anxiety symptoms, having had a depressive episode in the past and therefore qualifying for the major depressive disorder diagnosis. So clearly we have made the choice and our, the experts we talked to agree with this, that by having the entire waterfront of depression and anxiety covered, that we become the if approved, we can become the sort of go to regardless of the condition at presentation.

是的，我的意思是，我們已經明確地做出了選擇，從監管的角度來看，這些疾病雖然大量重疊，但正如您所說，它們確實作為不同的實體存在，而且肯定有一些患者沒有處於這種合併症的狀態，您患有其中一種。一般來說，醫療服務提供者習慣於做出診斷並確定治療的主要目標，因此我們認為，從醫療服務提供者的角度來看，擁有一個涵蓋兩種疾病的標籤使我們成為首選，無論患者是出現重度抑鬱發作還是出現更主要的焦慮症狀，過去是否曾發生過抑鬱發作，因此是否符合重度抑鬱障礙的診斷。所以很明顯我們已經做出了選擇，而且我們採訪過的專家也同意這一點，透過涵蓋憂鬱和焦慮的整個領域，我們成為瞭如果獲得批准，那麼無論當時的情況如何，我們都可以成為那種可以去的地方。

All right, thank you. I really appreciate that additional clarity.

好的，謝謝。我真的很感激這種額外的澄清。

Thank you. Ladies and gentlemen, this does conclude today's program, and you may now disconnect.

謝謝。女士們、先生們，今天的節目到此結束，大家可以斷開連結了。