Mind Medicine (MindMed) Inc (MNMD) 2024 Q3 法說會逐字稿

Good afternoon, and welcome to Mind Medicine third-quarter 2024 financial results and corporate update conference call.

下午好，歡迎參加 Mind Medicine 2024 年第三季財務業績和公司更新電話會議。

(Operator Instructions) This call is being webcast live on the Investors and Media section of MindMed's website at mindmed.co, and a recording will be available after the call.

（操作員指示）本次電話會議將在 MindMed 網站 mindmed.co 的投資者和媒體部分進行現場直播，通話結束後將提供錄音。

I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer at MindMed.

我想介紹 MindMed 首席企業事務長 Stephanie Fagan。

Please go ahead.

請繼續。

Thank you, operator.

謝謝您，接線生。

Good afternoon, everyone.

大家下午好。

Thank you for joining us today for a discussion of MindMed's third-quarter 2024 business highlights and financial results.

感謝您今天加入我們討論 MindMed 2024 年第三季的業務亮點和財務業績。

Leading the call today will be Rob Barrow, our Chief Executive Officer.

今天主持電話會議的將是我們的執行長 Rob Barrow。

He will be joined by Dr. Dan Karlin, our Chief Medical Officer; and Francois Lilienthal, our Chief Commercial Officer.

他將與我們的首席醫療官 Dan Karlin 博士一起參加；以及我們的首席商務官 Francois Lilienthal。

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

在我們準備好發言後，我們將開始問答環節。

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.

今天的電話會議的錄音和網路直播重播也將在網路上提供，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、有效性和監管及臨床進展、我們預期的現金流以及未來期望、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 10-K and our Form 10-Q 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 10-K 表年度報告和 10-Q 表。

Forward-looking statements are based on the assumptions, opinions, and estimates of management at the date the statements are made, including the nonoccurrence 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.

前瞻性陳述是基於作出陳述之日管理層的假設、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不發生，或 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, November 7, 2024.

請注意不要過度依賴這些前瞻性陳述，這些陳述是截至 2024 年 11 月 7 日做出的。

MindMed disclaims any obligation to update such statements even if management's views change, except as required by law.

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任何義務，除非法律要求。

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

說完這些，讓我把電話轉給 Rob。

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

感謝史蒂芬妮以及大家今天參加我們的電話會議。

I'm pleased to share our progress for the third quarter which builds upon our strong execution throughout the first half of the year.

我很高興與大家分享我們第三季的進展，這建立在我們上半年強勁執行力的基礎之上。

This has been an incredible year for MindMed, and we are even more excited about what lies ahead as we embark on our Phase 3 programs for MM120 orally disintegrating tablet or ODT in generalized anxiety disorder or GAD and in major depressive disorder or MDD.

今年對 MindMed 來說是不可思議的一年，隨著我們開始實施 MM120 口腔崩解片或 ODT 治療廣泛性焦慮症或 GAD 和重度憂鬱症或 MDD 的第三階段計劃，我們對未來更加興奮。

We remain on track to initiate our first Phase 3 study of MM120 ODT in GAD called the Voyage study by the end of this year.

我們仍計劃在今年年底前啟動 MM120 ODT 在 GAD 的首階段 3 期研究（稱為 Voyage 研究）。

We also remain on track to initiate our second Phase 3 study of MM120 ODT in GAD called the Panorama study and our first Phase 3 study of MM120 ODT in MDD called the Emerge study in the first half of 2025.

我們也將繼續按計劃在 2025 年上半年啟動 MM120 ODT 在 GAD 的第二階段 3 期研究（稱為 Panorama 研究）和 MM120 ODT 在 MDD 中的第一階段 3 期研究（稱為 Emerge 研究）。

These two indications, which together affect approximately 51 million adults in the US have seen little innovation in the past quarter century and represent a significant unmet medical need.

這兩種疾病共影響著美國約 5,100 萬成年人，在過去的 25 年裡幾乎沒有什麼創新，代表著巨大的未滿足的醫療需求。

We believe MM120 ODT represents a potentially transformational treatment for these populations and if approved, could offer patients a differentiated and compelling option in both GAD and MDD, positioning it as a best-in-class and our vision of a first-in-class treatment option targeting two of the most significant unmet needs in psychiatry.

我們相信，MM120 ODT 代表著對這些人群的一種潛在的變革性治療方法，如果獲得批准，可以為患者提供 GAD 和 MDD 方面的差異化和引人注目的選擇，使其成為同類最佳藥物，也是我們對一流治療方案的願景，針對精神病學中兩個最重要的未滿足需求。

We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic.

我們渴望提供一種真正具有變革性的治療方法，我們相信這種治療方法有可能改變正在發生的腦部健康流行病的軌跡。

As we progress toward the possibility of bringing MM120 ODT to patients in need, we recognize and embrace the unique opportunities and challenges that lie ahead to deliver and scale this potential.

隨著我們朝著將 MM120 ODT 帶給有需要的患者的可能性邁進，我們認識到並接受了實現和擴大這一潛力所面臨的獨特機會和挑戰。

While there is undoubtedly work to do in the coming years, our engagements with patients, prescribers, sites of care, and other key stakeholders have affirmed the broad recognition of a significant unmet medical need and the enthusiasm for the potential of MM120 ODT if approved, given the data we have generated to date.

儘管未來幾年無疑還有工作要做，但根據我們迄今為止產生的數據，我們與患者、處方人員、護理站點和其他主要利益相關者的接觸已經證實了人們對重大未滿足醫療需求的廣泛認可，以及對 MM120 ODT 一旦獲得批准的潛力的熱情。

We are continuing to demonstrate this unmet need by producing strong evidence on the enormous impact these disorders have on patients.

我們將繼續透過提供有力證據證明這些疾病對患者造成的巨大影響來證明這項尚未滿足的需求。

For example, at the European College of Neuropsychopharmacology, or ECNP, Congress in September, we shared an analysis from the 2022 US National Health and Wellness Survey showing that even small increases in the severity of GAD can significantly worsen the quality of life for patients.

例如，在 9 月的歐洲神經精神藥理學學院 (ECNP) 大會上，我們分享了 2022 年美國國家健康與保健調查的一項分析，該分析顯示，GAD 嚴重程度即使略有增加，也會顯著降低患者的生活品質。

Additionally, last month we presented a poster at the Academy of Managed Care Pharmacy Nexus 2024 meeting, highlighting the major economic burden of GAD, represented by significant increases in hospitalizations, absenteeism, and reductions in overall productivity.

此外，上個月我們在管理式醫療藥房聯盟 2024 會議上展示了一張海報，強調了 GAD 帶來的主要經濟負擔，其表現為住院率顯著增加、缺勤率顯著上升，以及總體生產力下降。

As we progress our commercial plans, we intend to continue strengthening this body of evidence with the goal of enabling patient access and engaging with the key stakeholders needed to bring this potential into reality.

隨著我們商業計劃的推進，我們打算繼續加強這一證據體系，以期使患者能夠獲得該證據，並與實現這一潛力所需的關鍵利益相關者進行接觸。

Before turning the call over to Dan, I'd like to highlight a few key points about our Phase 3 development strategy for MM120 ODT, which leverages the strong Phase 2b results we presented earlier this year and our partnership with FDA under the breakthrough therapy designation program.

在將電話轉給丹之前，我想強調一下我們 MM120 ODT 第 3 階段開發策略的幾個關鍵點，該策略利用了我們今年早些時候提出的強勁的第 2b 階段結果以及我們在突破性療法指定計劃下與 FDA 的合作。

A core principle of our development approach is to design clean studies that deliver clear results and are efficient to operationalize.

我們的開發方法的核心原則是設計清晰的研究，以提供清晰的結果並有效率地實施。

This principle is exemplified by our bold and unique decision early in development to eliminate psychotherapy and by our streamlined Phase 3 clinical trial designs, which aim to replicate the rapid and durable response after a single dose of MM120 that we observed in our Phase 2b study.

這項原則體現在我們在開發早期做出的大膽而獨特的決定，即消除心理治療，以及我們精簡的 3 期臨床試驗設計，旨在複製我們在第 2b 期研究中觀察到的單劑量 MM120 後的快速而持久的反應。

A methodological matter that has received a heightened amount of attention recently is functional unblinding and its impact on trials of psychedelics.

最近受到高度關注的一個方法論問題是功能性揭盲及其對迷幻藥試驗的影響。

To state the obvious, MM120 ODT and other drugs in the class have a clear perceptual effect for several hours after administration.

顯而易見的是，MM120 ODT 和其他同類的藥物在服用後數小時內均具有明顯的感知效果。

While the qualitative nature of these effects may be unique, the reality of functional unblinding in psychiatry is common to virtually every approved psychiatric drug.

雖然這些影響的定性性質可能是獨一無二的，但精神病學中功能性揭盲的現實幾乎對每一種核准的精神藥物來說都是常見的。

Nonetheless, we have implemented several strategies intended to address this and other methodological considerations across our Phase 2 and 3 programs.

儘管如此，我們在第 2 階段和第 3 階段計劃中實施了多項策略來解決這個問題和其他方法論上的考慮。

These include using central raters who are blinded to both treatment assignment and visit number, incorporating questionnaires to assess potential expectancy bias and unmasking, and in multiple of our studies, including additional control arms that are perceivable but not clinically active.

這些措施包括使用對治療分配和就診次數不知情的中央評估員，結合問卷調查來評估潛在的期望偏差和揭露，以及在我們的多項研究中包括可感知但不具有臨床活性的額外對照組。

Our continued interactions with the FDA further support alignment with the rigor and design of our approach.

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性。

And we believe our development strategy can deliver clear and compelling evidence on the safety and effectiveness of MM120 ODT in both GAD and MDD.

我們相信，我們的發展策略可以為 MM120 ODT 在 GAD 和 MDD 中的安全性和有效性提供明確而令人信服的證據。

Operationally, we anticipate streamlined and efficient patient enrollment across both of our Phase 3 programs, given the closely aligned design of our protocols for both the GAD and MDD indications.

在營運上，鑑於我們針對 GAD 和 MDD 適應症的方案設計緊密一致，我們預計兩個 3 期項目中的患者招募都將簡化且高​​效。

Our operational efficiency is enhanced by the inclusion of many of our highest performing sites from Phase 2 and our Phase 3 program.

透過納入第二階段和第三階段計畫中許多表現最佳的站點，我們的營運效率得到了提升。

Additionally, the planned sample size of Voyage is the same as our Phase 2b study, which we enrolled in approximately 12 months, and Voyage will also benefit from having 50% more sites than in our Phase 2b study.

此外，Voyage 的計畫樣本量與我們在約 12 個月內完成的 2b 期研究相同，而且 Voyage 也將受益於比 2b 期研究多 50% 的站點。

Our clinical protocols are designed with operational input from sites and specific attention to enabling enrollment so that we can rapidly recruit a representative sample of participants.

我們的臨床方案是根據來自站點的操作輸入而設計的，並特別注重實現招募，以便我們能夠快速招募具有代表性的參與者樣本。

Our clinical team and entire R&D organization continue to lead the field in quality and efficiency of execution, and we seek to build on that momentum going into our Phase 3 programs.

我們的臨床團隊和整個研發組織繼續在執行品質和效率方面保持領先地位，我們希望在進入第三階段計劃時繼續保持這一勢頭。

We're invigorated by the enthusiasm expressed by patients, trial sites, and study investigators and believe this broad enthusiasm will continue to support our goals of rapid progression and seamless execution in Phase 3.

患者、試驗地點和研究人員所表現出的熱情讓我們感到振奮，並相信這種廣泛的熱情將繼續支持我們在第 3 階段快速進展和無縫執行的目標。

Now let me turn the call over to Dr. Dan Karlin, Chief Medical Officer of MindMed, to discuss our clinical development programs in more detail.

現在，讓我將電話轉給 MindMed 首席醫療官 Dan Karlin 博士，更詳細地討論我們的臨床開發計劃。

Dan?

擔？

Thank you, Rob.

謝謝你，羅布。

Our development plan for GAD includes two pivotal clinical studies, Voyage and Panorama.

我們針對 GAD 的開發計劃包括兩項關鍵臨床研究，Voyage 和 Panorama。

Each study will consist of two parts.

每項研究由兩部分組成。

Part A is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120 ODT versus placebo.

A 部分是一項為期 12 週的隨機、雙盲、安慰劑對照、平行組研究，評估 MM120 ODT 與安慰劑相比的療效和安全性。

Part B is a 40-week extension period with opportunities for open-label treatment, designed to provide important long-term data on the durability and treatment patterns for MM120 ODT.

B 部分是為期 40 週的延長期，具有開放標籤治療的機會，旨在為 MM120 ODT 的耐用性和治療模式提供重要的長期數據。

Voyage is anticipated to enroll approximately 200 participants randomized 1:1 to receive MM120 ODT 100 micrograms or placebo.

Voyage 預計將招募約 200 名參與者，以 1:1 的比例隨機分配接受 MM120 ODT 100 微克或安慰劑。

Panorama is anticipated to enroll approximately 240 participants randomized 5:2:5 to receive MM120 ODT 100 micrograms, MM120 ODT 50 micrograms or placebo.

Panorama 預計將招募約 240 名參與者，以 5:2:5 的比例隨機分配接受 MM120 ODT 100 微克、MM120 ODT 50 微克或安慰劑。

In accordance with FDA guidance and our regulatory discussions to date, our clinical program for MM120 ODT continues to use complementary study designs intended to address key methodological considerations such as functional unblinding and participant selection.

根據 FDA 指導和我們迄今為止的監管討論，我們的 MM120 ODT 臨床計畫繼續使用互補研究設計，旨在解決關鍵的方法學考慮因素，例如功能揭盲和參與者選擇。

For example, in Panorama we have included a 50-microgram arm to confound participant's ability to accurately assess the dose condition to which they have been randomized.

例如，在 Panorama 中，我們加入了 50 微克組，以混淆參與者準確評估隨機分配的劑量條件的能力。

This approach builds on our Phase 2b evidence where we demonstrated that despite functional unblinding at all tested doses, the lower doses, 25 and 50 micrograms did not demonstrate a meaningful clinical response.

這種方法建立在我們 2b 期證據的基礎上，我們證明，儘管在所有測試劑量下都進行了功能性揭盲，但較低劑量（25 和 50 微克）並未表現出有意義的臨床反應。

This supports our view that the anxiolytic effect of MM120 is a true response to the treatment.

這支持了我們的觀點，即 MM120 的抗焦慮作用是對治療的真正反應。

While we previously observed an almost 8-point improvement for MM120 over placebo at week 12, both Voyage and Panorama have been designed to have 90% power to detect a 5-point improvement over placebo based on certain statistical assumptions.

雖然我們之前觀察到 MM120 在第 12 週比安慰劑提高了近 8 個點，但基於某些統計假設，Voyage 和 Panorama 都被設計為具有 90% 的功效來檢測比安慰劑提高 5 個點。

Additionally, both studies will use an adaptive design with an interim blinded sample size re-estimation, which allows for an increase in sample size up to 50% in each study.

此外，兩項研究都將採用自適應設計，並進行中期盲樣本量重新估計，這使得每次研究的樣本量可增加高達 50%。

This approach helps adjust for unexpected variability in nuisance parameters, specifically dropout rates and pooled variants of HAM-A response, maintaining statistical power and enhancing the interpretability of our results.

這種方法有助於調整幹擾參數的意外變化，特別是 HAM-A 反應的退出率和匯總變量，從而保持統計能力並增強結果的可解釋性。

Key elements such as inclusion and exclusion criteria will largely mirror our successful phase IIb trial of MM120 in GAD.

納入和排除標準等關鍵要素將在很大程度上反映我們在 GAD 中對 MM120 進行的 IIb 期試驗所取得的成功。

Both Phase 3 studies will recruit adults aged 18 to 74 with a diagnosis of GAD and a HAM-A score of 20 or greater.

兩項 3 期研究都將招募年齡在 18 歲至 74 歲之間、被診斷為 GAD 且 HAM-A 評分為 20 或更高的成年人。

During Part B of our Phase 3 studies, investigators will closely monitor participants using electronic patient reported outcomes, central radar assessed HAM-As and other clinician administered scales.

在我們第三階段研究的 B 部分期間，研究人員將使用電子病患報告的結果、中央雷達評估的 HAM-As 和其他臨床醫生管理的量表密切監測參與者。

Participants will be eligible for treatment with MM120 ODT 100 micrograms if their HAM-A score reaches 16 or higher with up to four treatments available through Part B. Importantly, we believe the study design allows for an assessment of the durability of the treatment effect, the need for and response to retreatment, and the long-term safety of MM120 ODT.

如果參與者的 HAM-A 評分達到 16 或更高，他們將有資格接受 MM120 ODT 100 微克治療，並且透過 B 部分最多可以接受四種治療。

Key outcomes from Part B will include time to repeated treatment or inefficacy.

B 部分的關鍵結果包括重複治療或無效的時間。

We will also assess safety data on repeated treatment, average treatments per year, and response to these treatments.

我們還將評估重複治療、每年平均治療次數以及對這些治療的反應的安全性數據。

This information will be valuable in understanding the longer-term dynamics of MM120 ODT treatment in GAD patients.

這些資訊對於了解 MM120 ODT 對 GAD 患者的長期治療動態非常有價值。

Overall, both Voyage and Panorama are designed to be consistent with our successful Phase 2b trial of MM120 in GAD, including using the HAM-A as our primary outcome measure.

總體而言，Voyage 和 Panorama 的設計都與我們在 GAD 中成功的 MM120 第 2b 期試驗保持一致，包括使用 HAM-A 作為我們的主要結果測量指標。

The primary endpoint for the Phase 3 programs is the change from baseline to week 12 which is consistent with the durability we observed in Phase 2b.

階段 3 計畫的主要終點是從基線到第 12 週的變化，這與我們在第 2b 階段觀察到的持久性一致。

As Rob mentioned earlier, we remain on track to initiate Voyage by the end of this year and initiate the second Phase 3 study Panorama in the first half of 2025.

正如 Rob 之前提到的，我們將按計劃在今年年底啟動 Voyage 計劃，並在 2025 年上半年啟動第二階段 3 期研究 Panorama。

We anticipate top line data from Part A of Voyage in the first half of 2026 and from Part A of Panorama in the second half of 2026.

我們預計《Voyage》 A 部分將於 2026 年上半年獲得營收數據，《Panorama》 A 部分將於 2026 年下半年獲得營收數據。

Turning to MM120 ODT for the treatment of MDD, we are excited about the expansion of our pipeline.

談到MM120 ODT用於治療MDD，我們對管道的擴展感到非常興奮。

Data from our Phase 2 GAD study led to our decision to pursue MDD as an additional indication for MM120 ODT given its demonstrated potential for antidepressant effects.

我們根據第 2 階段 GAD 研究的數據，決定將 MDD 作為 MM120 ODT 的附加適應症，因為已證明具有抗憂鬱作用的潛力。

In the 100-microgram dose group in our Phase 2b, we observed an 18.7 point improvement from baseline in the Montgomery-Asberg Depression Rating Scale or MADRS at week 12.

在我們第 2b 階段的 100 微克劑量組中，我們觀察到第 12 週的蒙哥馬利-阿斯伯格憂鬱量表或 MADRS 較基線提高了 18.7 分。

This represented a 6.4 point advantage over placebo, which was statistically significant with a p-value less than 0.01. These results are particularly encouraging given that the study wasn't powered for this endpoint and that baseline MADRS scores were lower than we would expect in patients experiencing a major depressive episode, which appeared to create a ceiling effect on the response to MM120 as measured by the MADRS.

這比安慰劑高出 6.4 個百分點，具有統計意義，p 值小於 0.01。這些結果尤其令人鼓舞，因為該研究並未針對該終點進行研究，且基線 MADRS 評分低於我們預期的重度憂鬱發作患者的評分，這似乎對 MADRS 測量的 MM120 反應產生了天花板效應。

Like the Phase 3 development program in GAD, our MDD program will consist of two pivotal clinical studies.

與 GAD 的 3 期開發計劃一樣，我們的 MDD 計劃將包括兩項關鍵臨床研究。

Our first study, Emerge, will be comprised of two parts: Part A, 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 ODT subject to certain conditions for treatment eligibility.

我們的第一項研究 Emerge 將由兩部分組成：A 部分，一項為期 12 週的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 ODT 的開放標籤治療，但須符合某些治療資格條件。

Emerge is anticipated to enroll at least 140 participants with a primary diagnosis of MDD randomized 1:1 to receive MM120 ODT 100 micrograms or placebo.

Emerge 預計將招募至少 140 名主要診斷為 MDD 的參與者，以 1:1 的比例隨機分配接受 MM120 ODT 100 微克或安慰劑。

The primary endpoint in Emerge will be the change from baseline and MADRS score at week six between MM120 ODT 100 micrograms in placebo.

Emerge 的主要終點是 MM120 ODT 100 微克與安慰劑之間第六週 MADRS 評分相對於基線的變化。

The design and timing of a second MDD study will be informed by the progress from Emerge and additional regulatory discussions.

第二次 MDD 研究的設計和時間將根據 Emerge 的進展和其他監管討論的結果來確定。

With that update, I will turn the call back over to Rob to discuss third quarter financial results.

更新完上述內容後，我將把電話轉回給 Rob，討論第三季的財務結果。

Rob?

搶？

Thanks, Dan.

謝謝，丹。

Turning to our financial results for the quarter ended September 30, 2024, we ended the quarter with cash and cash equivalents totaling $295.3 million compared to $99.7 million as of December 31, 2023.

回顧我們截至 2024 年 9 月 30 日的季度財務業績，截至本季度末，我們的現金和現金等價物總額為 2.953 億美元，而截至 2023 年 12 月 31 日為 9970 萬美元。

We believe that our cash and cash equivalents as of September 30, 2024, will be sufficient to fund our operations into 2027.

我們相信，截至 2024 年 9 月 30 日的現金和現金等價物將足以資助我們到 2027 年的營運。

Importantly, we believe that we have sufficient cash to extend our runway at least 12 months beyond the top line data readout for our first Phase 3 study of MM120 ODT in GAD.

重要的是，我們相信我們有足夠的現金來將我們的營運時間延長至少 12 個月，超出我們對 ​​GAD 中的 MM120 ODT 的第一階段 3 期研究的頂線數據讀數。

Research and development expenses were $17.2 million for the quarter ended September 30, 2024, compared to $13.2 million for the same period in 2023, representing an increase of $4 million.

截至 2024 年 9 月 30 日的季度研發費用為 1,720 萬美元，而 2023 年同期為 1,320 萬美元，增加了 400 萬美元。

The increase was primarily due to increases of $2.1 million in expenses related to MM120 ODT's advancement into pivotal studies in GAD, an increase of $0.9 million in expenses related to our MM402 program, an increase of $0.6 million in internal personnel costs as a result of increasing research and development capacities, and an increase of $0.4 million in expenses related to preclinical activities.

增加的主要原因是與 MM120 ODT 進入 GAD 關鍵研究相關的費用增加了 210 萬美元，與我們的 MM402 項目相關的費用增加了 90 萬美元，由於研發能力的提高導致內部人員成本增加了 60 萬美元，以及與臨床前活動相關的費用增加了 40 萬美元。

We do anticipate R&D expenses to ramp up in 2025 as we get the second Phase 3 study in GAD and our first Phase 3 study in MDD up and running.

隨著 GAD 第二階段 3 期研究和 MDD 第一階段 3 期研究的啟動，我們預計 2025 年的研發費用將會增加。

General and administrative expenses were $7.6 million for the quarter ended September 30, 2024, compared to $8.4 million for the quarter ended September 30, 2023, a decrease of $0.8 million.

截至 2024 年 9 月 30 日的季度，一般及行政費用為 760 萬美元，而截至 2023 年 9 月 30 日的季度為 840 萬美元，減少了 80 萬美元。

The decrease was primarily attributable to lower spending in legal and commercial activities, partially offset by increased stock-based compensation expense.

下降主要歸因於法律和商業活動支出的減少，但股票薪酬費用的增加部分抵消了這種影響。

The company's net loss for the quarter ended September 30, 2024, was $13.7 million compared to $17.9 million for the same period in 2023, a decrease of $4.2 million.

該公司截至 2024 年 9 月 30 日的季度淨虧損為 1,370 萬美元，而 2023 年同期為 1,790 萬美元，減少了 420 萬美元。

The decrease was primarily due to changes in the fair value of the warrants issued in our September 2022 underwritten offering of $5.3 million, partially offset by an increase in research and development expense.

下降的主因是我們 2022 年 9 月承銷發行中發行的 530 萬美元認股權證的公允價值變動，但部分被研發費用的增加所抵銷。

In closing, MindMed is entering a pivotal phase in our growth with several key milestones expected in the next few years.

最後，MindMed 正在進入發展的關鍵階段，預計未來幾年將實現幾個關鍵的里程碑。

We believe successfully completing three Phase 3 studies will drive significant value, and we are focused on maintaining our strong track record of execution as we advance our MM120 ODT Phase 3 studies and build out the organization with key capabilities for continued success.

我們相信，成功完成三項第 3 階段研究將帶來巨大的價值，在推進 MM120 ODT 第 3 階段研究和建立具有持續成功關鍵能力的組織的過程中，我們專注於保持強大的執行記錄。

We believe MM120 ODT represents a novel and highly differentiated treatment option for people living with GAD and MDD.

我們相信 MM120 ODT 為患有 GAD 和 MDD 的患者提供了一種新穎且高度差異化的治療選擇。

The brain health crisis continues to persist and grow and bringing forward transformational innovation that will potentially benefit millions of people is what unites us at MindMed.

大腦健康危機持續且愈演愈烈，提出可能造福數百萬人的變革性創新正是 MindMed 團結我們的原因。

I'm very proud of the efforts of our team and want to thank them for their dedication as we work to deliver on the therapeutic potential of our pipeline and reshape the treatment landscape for people living with brain health disorders.

我為我們團隊的努力感到非常自豪，並要感謝他們的奉獻精神，我們致力於發揮我們產品線的治療潛力，並重塑腦部健康障礙患者的治療前景。

With that, I'd like to thank you all again for joining us today.

最後，我想再次感謝大家今天的出席。

And the team and I are happy to take your questions.

我和我的團隊很樂意回答您的問題。

(Operator Instructions) Marc Goodman, Leerink Partners.

(操作員指示) Marc Goodman，Leerink Partners。

This is Madhu on the line for Marc.

我是 Madhu，為 Marc 接聽電話。

I thought the functional unblinding data that you presented at the psych congress recently was really interesting around the unblinding for central raters.

我認為您在最近的心理學大會上展示的功能性揭盲數據對於中央評估者的揭盲來說確實很有趣。

How do you think having fewer arms in the Phase 3 program could impact central rater unblinding?

您認為第三階段計畫中試驗組數量減少會對中央評估者揭盲產生什麼影響？

And is this type of analysis showing lack of central rater unblinding something that would be important for approval?

並且，這種分析是否表明缺乏中央評級者揭盲，這對於批准來說很重要？

Yes.

是的。

Thanks so much for the question, Madhu.

非常感謝你提問，Madhu。

Certainly, the data set we generated in Phase 2 is going to be an important component of our overall data package we try to take to a submission.

當然，我們在第二階段產生的資料集將成為我們嘗試提交的整體資料包的重要組成部分。

So when we look at the results, which you're mentioning, which for everyone's sake, demonstrated that 80% of the rating events in our Phase 2 study, the raters described as being unsure of whether or not the patient received active drug or placebo.

因此，當我們查看您提到的結果時，為了大家的利益，該結果顯示，我們第二階段研究中 80% 的評級事件，評級者表示不確定患者是否接受了有效藥物或安慰劑。

And where there was a guess, they were generally wrong and a pretty uniform distribution across all of the treatment arms.

而如果是猜測的話，他們通常都是錯誤的，並且在所有的治療組中，猜測的分佈相當均勻。

Those data are particularly informative because we had the five arms in that study.

這些數據特別具有參考價值，因為我們在研究中涵蓋了五個分數。

And so we can look at the study somewhat in isolation as evidence that functional unblinding both at the patient level didn't have an impact on the study outcomes as we saw consistent functional unblinding across all treatment groups, but only two of the groups actually respond statistically and clinically significantly.

因此，我們可以孤立地看待這項研究，將其作為證據，證明患者層面的功能性揭盲對研究結果沒有影響，因為我們看到所有治療組的功能性揭盲都是一致的，但只有兩個組實際上在統計和臨床上具有顯著反應。

And then from a rater standpoint, it speaks to the clarity and the uncertainty with which there was any unblinding that came out during the structured interviews for the primary endpoint.

然後從評估者的角度來看，它說明了在主要終點的結構化訪談中出現的揭盲的清晰度和不確定性。

So we don't certainly have an expectation that that would dramatically change as we go forward into the Phase 3 program.

因此，我們當然不期望隨著進入第三階段計劃，這種情況會發生巨大變化。

Those data on functional unblinding, because we mentioned during the call are something that is extremely common in psychiatry.

我們在通話中提到，有關功能揭盲的數據在精神醫學中極為常見。

Functional unblinding is the reality for virtually every psychiatry drug.

功能性揭盲幾乎是每種精神藥物的現實情況。

And so while an area of can increase scrutiny and focus, in our discussions with the agency and certainly our anticipation of as we develop the continued development program, these will be supportive and informative.

因此，雖然某個領域可以增加審查和關注，但在我們與該機構的討論中，以及在我們對制定持續發展計劃的預期中，這些都將提供支持和資訊。

But at the end of the day, what we need to demonstrate is the safety and effectiveness of the drug and in so doing should be held to the same regulatory standard of all previous drugs, which is to show a statistical and clinically meaningful difference over the placebo.

但歸根結底，我們需要證明的是藥物的安全性和有效性，並且在這樣做時應該遵守與所有先前的藥物相同的監管標準，即與安慰劑相比具有統計學和臨床意義上的差異。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

This is Nevin on for Brian.

這是 Nevin 代替 Brian 上場的。

So following some recent commentary from another psychedelic competitor in depression concerning some trial recruitment difficulties that they were seeing, do you foresee having any particular difficulties as you look to initiate Voyage and Panorama in GAD?

因此，根據最近另一位迷幻憂鬱症競爭對手關於他們所遇到的一些試驗招募困難的評論，您是否預見到在 GAD 中啟動 Voyage 和 Panorama 時會遇到什麼特殊困難？

And then do you think this might be an indication-specific problem or perhaps due to the specific trial design given that Dan mentioned some specific issues surrounding finding therapists and getting appointments and spaces?

那麼，您是否認為這可能是特定適應症的問題，或者可能是由於特定的試驗設計，因為丹提到了一些圍繞尋找治療師和獲得預約和空間的具體問題？

And then how are you looking to maybe reduce some of that friction that might be there with any enrollment difficulties?

那麼您希望如何減少入學困難而可能出現的摩擦呢？

Yes, thanks, Nevin.

是的，謝謝，內文。

It's a great question.

這是一個很好的問題。

Our team, I cannot say enough about our clinical development team and how incredibly well they can operationalize these protocols.

我們的團隊，我對我們的臨床開發團隊以及他們如何出色地實施這些協議讚不絕口。

Even when we look back to our Phase 2 study, the pace at which we were able to enroll that study in GAD really set the standard for the field and was faster than we've seen in virtually any other study.

即使回顧我們的第二階段研究，我們在 GAD 中開展該研究的速度也確實為該領域樹立了標準，而且比我們在幾乎任何其他研究中看到的速度都要快。

And we certainly expect and plan to continue to set the standard for the field in that way.

我們當然希望併計劃繼續以這種方式為該領域樹立標準。

I'll say we have a very hands-on, close engagement with all of our clinical sites.

我想說的是，我們與所有臨床站點都有非常密切的聯繫。

We certainly have -- there are logistical challenges with the conduct of these studies, but that's why we have the experts on our team to navigate that and an ability to really seamlessly execute and get those sites set up and get patients scheduled for dosing.

我們當然有——進行這些研究存在後勤挑戰，但這就是為什麼我們團隊中有專家來解決這個問題，並且有能力真正無縫地執行和建立這些站點並安排患者服藥。

So we have not seen any change that would indicate anything other than a continuation of the success we had in enrolling the study in Phase 2.

因此，我們沒有看到任何變化，這些變化除了表明我們在第二階段研究中的成功得以延續之外。

And so I want to continue building on that as we go forward.

因此，我希望在我們前進的過程中繼續在此基礎上再接再厲。

Again, we have around 30 sites in the Voyage study, which is the same size as our Phase 2 study where we had 20 sites.

再次，我們在 Voyage 研究中擁有大約 30 個站點，與我們的第 2 階段研究的 20 個站點的規模相同。

So even there, we'll have additional sites while targeting only the same number of patients.

所以即使在那裡，我們也會有更多站點，但目標患者數量仍相同。

We go to great lengths across the board, everything from the degree of our site engagement to central and local recruiting campaigns.

我們在各方面都竭盡全力，從網站參與程度到中央和地方的招募活動。

But there's also a dynamic of it was an intentional choice for us to go after the broader markets, both from a commercial standpoint, but also to operationalize these studies.

但我們也有意選擇追求更廣大的市場，不僅從商業角度，也為了將這些研究付諸實行。

Going after a general GAD and a general MDD population allows us the largest opportunity to access those patients.

追蹤一般的GAD和一般的MDD人群使我們有最大的機會接觸到這些患者。

But in trials also allows us the greatest ease in getting those patients screened into our studies.

但在試驗中，我們也能夠最輕鬆地將這些患者篩選到我們的研究中。

And then when we think about across these programs, by having both GAD and MDD up and running at the same sites in many instances, it gives us a high degree of efficiency so that the patients who are screened for one indication, but for instance have a major depressive disorder and major depressive episode could then be moved over into the MDD study.

然後，當我們考慮這些項目時，透過在許多情況下在同一地點同時進行 GAD 和 MDD 研究，它為我們提供了高度的效率，以便那些只篩檢一種適應症但患有重度憂鬱症和重度憂鬱症發作的患者可以轉移到 MDD 研究中。

So everything about the study design through to how we operationalize it is intended to go efficiently, quickly, with the highest possible quality, and again, every expectation that will continue executing as we go forward in Phase 3.

因此，從研究設計到如何實施，一切都旨在高效、快速、盡可能高品質地進行，並且，隨著我們進入第三階段，所有的期望都將繼續執行。

Charles Duncan, Cantor.

查爾斯鄧肯，領唱者。

Good afternoon, Rob and team.

下午好，羅布和團隊。

Thanks for all the information on the trial designs.

感謝您提供有關試驗設計的所有資訊。

That was quite helpful.

這非常有幫助。

I did have a follow up question to the last one, and that is regarding enrollment pacing.

我確實對上一個問題有一個後續問題，即有關招生節奏的問題。

I guess, what would you anticipate?

我猜，您會期待什麼？

It does seem like you're going to be using more sites, but some of them are somewhat naive to evaluating LST.

看起來您確實會使用更多站點，但其中一些站點對於評估 LST 還不夠成熟。

And so I guess if you think back to the Phase 2b experience, could you assume a similar timeframe for that Voyage study to enroll?

所以我想，如果您回想一下第 2b 階段的經歷，您能否假設 Voyage 研究的招募時間框架與此類似？

Or could it pace even more quickly than what you showed in the first go round?

或者它的速度能否比你第一輪所展示的還要快？

Yes.

是的。

Thanks so much, Charles.

非常感謝，查爾斯。

So our guidance for the first study is that we'll have top-line readout from Part A of the study in the first half of 2026, and for the other two Phase 3 studies would be in the second half of 2026.

因此，我們對第一項研究的指導是，我們將在 2026 年上半年獲得研究 A 部分的頂線讀數，而另外兩項第 3 階段研究將在 2026 年下半年獲得頂線讀數。

That is certainly something that we believe we're on track to execute and do.

我們堅信，我們正在按計劃執行並實現這一目標。

We will, of course, be trying to streamline and accelerate enrollment at every opportunity and think the team is doing an incredible job at getting these sites up and running and ultimately are excited about the enthusiasm we see both from potential participants in the study, but also the investigative sites in particular.

當然，我們會盡力利用每一個機會簡化和加速招生工作，並認為團隊在建立和運行這些站點方面做得非常出色，最終，我們對研究中的潛在參與者以及調查站點所表現出的熱情感到興奮。

So while we can't really speak to specific enrollment rates on any given month, we certainly believe we're on track and in a great position to execute all these studies.

因此，雖然我們無法真正說出任何特定月份的具體入學率，但我們確信我們正按計劃並有能力執行所有這些研究。

If I heard Dan correctly, he mentioned that there was an interim analysis that would be useful for conditional power for using an adaptive design.

如果我沒聽錯，丹提到有一個中期分析對於使用自適應設計的條件功率很有用。

What triggers that interim analysis?

什麼原因引發了該中期分析？

Could you give us a sense of the number of patients or some other milestone?

您能告訴我們患者人數或其他里程碑的情況嗎？

At a really high level, I'd say generically, typically those analyses are done somewhere around the time of the halfway enrollment mark in studies.

從高層次上講，我想一般來說，這些分析通常是在學習到一半左右時進行的。

And we certainly think we would be generally in line with that sort of timeline.

我們當然認為我們基本上會遵循這樣的時間表。

So when we enroll about half of the participants would be a reasonable time to take a look in a blinded fashion, conduct the blinded sample size re-estimation, and determine if there's a slight increase in sample size required to maintain the power that we've established at the beginning of the study.

因此，當我們招募大約一半的參與者時，這將是一個合理的時間，以盲法進行觀察，進行盲法樣本量重新估計，並確定是否需要稍微增加樣本量以維持我們在研究開始時確定的功效。

And then my final question is regarding the GAD patient population or sample that you intend to enroll.

我的最後一個問題是關於您打算招募的 GAD 患者群體或樣本。

I think Dan mentioned HAM-A of 20 or greater being required.

我認為丹提到需要 20 或更高的 HAM-A。

But are you planning to track any other phenotypic pieces of information, such as duration and symptom onset or prior therapies?

但是您是否計劃追蹤任何其他表型訊息，例如持續時間和症狀出現或之前的治療方法？

And are you restricting enrollment on either of those phenotypic, call-out characters?

您是否限制這些表型或呼喚角色的註冊？

Yes, I'll turn this one over to Dan.

是的，我將把這個交給丹。

Yes, thanks for the question, Charles.

是的，謝謝你的提問，查爾斯。

Nice to hear from you.

很高興收到你的來信。

So while the enrollment criteria for the HAM-A is set at 20, we absolutely will track a ton of other phenotypic details, certainly including treatment history, treatment that someone might come to screening with that need to be tapered off.

因此，雖然 HAM-A 的入組標準設定為 20，但我們絕對會追蹤大量其他表型細節，肯定包括治療史、患者在篩檢時可能需要逐漸減少的治療。

Certainly, we would be aware of those, but we get a more detailed treatment history.

當然，我們會意識到這些，但我們會獲得更詳細的治療歷史。

So both that they have had some number of treatments and what those treatments are and their duration and this sort of thing.

因此，他們既要接受一定數量的治療，又要了解這些治療的具體內容、治療持續時間等。

So while we don't use prior treatment as an inclusion or exclusion criteria, we certainly will be able to look at the performance of the drug based on phenotypic data like that at entry.

因此，雖然我們不使用先前的治療作為納入或排除標準，但我們當然能夠根據入組時的表型數據來查看藥物的表現。

Were any of those phenotypic details drivers to call it efficacy or even enrollment in the Phase 2b?

這些表型細節是否有任何驅動因素使其被稱為療效，甚至是進入第 2b 階段？

You'll recall that the 40 per arm design of the Phase 2b pretty small on a per arm basis.

您會記得，Phase 2b 的每個臂的設計為 40 個，從每個臂的基礎來看相當小。

So while we can of course we slice and dice those data and try to tease out anything we can.

因此，我們當然可以對這些數據進行分析，並嘗試找出任何我們能找出的東西。

But with the group sizes we work our way down to, we weren't detecting any difference in any predictors of response there.

但是，隨著群體規模的縮小，我們沒有發現任何反應預測因子的差異。

Got it.

知道了。

Thanks for the reminder.

謝謝提醒。

Looking forward to seeing this one kick off.

期待看到這場比賽的開始。

Francois Brisebois, Oppenheimer.

弗朗索瓦·布里斯博瓦、奧本海默。

I was just wondering, is there any chance, any thought about waiting for Part B before reading out Part A?

我只是想知道，是否有可能，有沒有想過先等待 B 部分再閱讀 A 部分？

Or is this kind of a classic Part A happens, you have the data, and you read it out?

或者這是經典的 A 部分發生的情況，您有數據，並且您將其讀出來？

Then I have follow-ups.

然後我會跟進。

Yes.

是的。

Thanks, Franc.

謝謝，弗蘭克。

No, we intend to, once we complete the 12-week portion of our study to lock the database for that portion of the study and read out the top-line results there.

不，我們打算在完成 12 週的研究後鎖定該部分研究的資料庫並讀出最重要的結果。

So certainly, while patients will continue on, and we do not anticipate on individual patient basis unblinding or telling those patients what they received in Part A of the study.

因此可以肯定的是，雖然患者會繼續接受治療，但我們不會針對個別患者揭盲或告訴他們他們在研究 A 部分中接受了什麼治療。

We certainly have the capability, like in any study to lock and provide an analysis of the group results.

我們當然有能力，就像在任何研究中一樣，鎖定並提供對小組結果的分析。

Okay, great.

好的，太好了。

And on this is kind of a riffing off the prior question from Charles here.

這有點像是查爾斯先前提出的問題。

The interim readout, is there any way that interim could kind of trigger an early stoppage?

中期讀數，中期讀數是否有可能引發提早停止？

Like how blinded is this?

這是有多盲目？

Where could it trigger an early stoppage whether or not for either the reason that things are going great, and you're there, and you can stop, or things are not looking good.

無論是因為事情進展順利，而您已經在那裡，而您可以停下來，還是事情看起來不太好，都可能導致提前停止。

Any way this could trigger some sort of readout prior to the final?

這是否會在決賽前引發某種形式的解讀？

Yes, thanks for the question.

是的，謝謝你的提問。

No, the blinded interim re-estimation, so this adaptive design, there's no alpha spend or inferential testing that happens.

不，盲法中期重新估計，所以這種自適應設計，沒有發生 alpha 支出或推理測試。

We're simply making sure that at that point that the nuisance parameters that Dan mentioned, right?

我們只是想確保丹提到的干擾參數在那時存在，對嗎？

So the enrollment, that the dropout rate and the variance in the pooled distribution of HAM-A scores that those are consistent with the assumptions we've made.

因此，入學率、輟學率以及 HAM-A 分數匯總分佈的變異數與我們所做的假設一致。

We don't look at anything about the group's actual response from baseline or versus one another.

我們不會從基線或相互關係的角度來觀察該組的實際反應。

It's simply to make sure that a nuisance parameter doesn't reduce the actual realized power in the study.

這只是為了確保幹擾參數不會降低研究中實際實現的功率。

So we won't be testing for futility or early efficacy or spending any alpha or doing any inferential tests at that time.

因此，我們不會測試無效性或早期功效，也不會花費任何 alpha 或進行任何推理測試。

Great.

偉大的。

And then lastly, and I don't know if you're willing or want to comment on this.

最後，我不知道您是否願意或想要對此發表評論。

But any thoughts on the elections and what it can do to the space?

但是對於選舉以及它對太空的影響您有什麼看法嗎？

Thank you.

謝謝。

Yes, no, it's certainly been an eventful political week.

是的，不，這確實是多事的一周。

We've had broad engagement with both state level, local and federal officials in many branches of government and have seen the broad awareness of the impact of mental health and brain health disorders in this country.

我們與許多政府部門的州級、地方和聯邦官員進行了廣泛的接觸，並且看到了人們對這個國家精神健康和腦部健康障礙影響的廣泛認識。

And certainly, anxiety and depression having grown substantially and being so burdensome on patients.

當然，焦慮和憂鬱症已經大幅增加，並給患者帶來了沉重的負擔。

And from a public health standpoint, we see broad willingness to engage in a really broad enthusiasm for the potential that this could represent.

從公共衛生的角度來看，我們看到人們普遍願意以廣泛的熱情參與其中，並發揮這可能帶來的潛力。

(Operator Instructions) Patrick Trucchio, H.C. Wainwright.

(操作員指示) Patrick Trucchio，H.C.溫賴特。

Good afternoon, and congrats on all the progress.

下午好，祝賀你取得的所有進展。

The first question is just to what extent you would expect the readout from Voyage to provide a read-through to the Panorama trial?

第一個問題是，您希望 Voyage 的讀數在多大程度上為 Panorama 試驗提供參考？

And the second question is just on the MDD program.

第二個問題只是關於 MDD 計劃。

I'm just curious what are you looking to learn from additional regulatory discussion regarding the second potential Phase 3 trial?

我只是好奇，您希望從有關第二次潛在的 3 期試驗的額外監管討論中了解到什麼？

And is there a possibility you might be able to move forward with just a single -- just one Phase 3 trial?

有沒有可能只進行一次──僅一次第三階段試驗就能推進下去？

Yes.

是的。

Thanks so much.

非常感謝。

On that latter point, I'll just say that we certainly anticipate doing two studies.

關於後一點，我只想說，我們當然希望進行兩項研究。

We always will look for opportunities to accelerate our programs.

我們將始終尋找機會來加速我們的計劃。

But we'll certainly have plans in place and what will be exploring further the timing and the exact design of that second study.

但我們肯定會制定計劃，並將進一步探索第二項研究的時間表和具體設計。

In terms of those regulatory interactions, it's simply a matter of ensuring that we have complete alignment from a programmatic standpoint across the indications, but especially in depression that we -- the second study is aligned with what would be required for submission for that indication.

就這些監管互動而言，這只是一個確保我們從程序角度對所有適應症完全一致的問題，尤其是在抑鬱症方面，我們 - 第二項研究與該適應症的提交要求相一致。

So as that unfolds and as we get clarity on the exact timing and design of that study, we'll certainly be announcing that at a later date.

因此，隨著事情的進展以及我們對該研究的具體時間和設計的明確，我們肯定會在稍後宣布這一消息。

And in terms of read-through, certainly, as we continue to build a body of evidence and hopefully see as compelling of results as we saw from the Phase 2 study, we want to demonstrate consistency and response.

就通讀而言，當然，隨著我們繼續建立證據體系，並希望看到與第二階段研究一樣令人信服的結果，我們希望展示一致性和反應。

I think certainly with the complementary designs that we're using across our Phase 2 and 3 programs, we have everywhere from a five-arm study that we conducted in Phase 2 to now two- and three-arm studies that we're conducting in Phase 3.

我認為，我們在第 2 階段和第 3 階段專案中使用的互補設計，包括從第 2 階段進行的五組研究到現在在第 3 階段進行的兩組和三組研究。

And we want to see a consistent response.

我們希望看到一致的回應。

We ideally see continued response to MM120.

理想情況下，我們希望看到對 MM120 的持續響應。

And to the extent we see really promising results from our first Phase 3, it certainly will continue to build our confidence in the repeatability of that.

並且，就我們看到的第三階段第一階段確實有希望的結果而言，這肯定會繼續增強我們對其可重複性的信心。

Right.

正確的。

And then if I could, just a follow-up question on the functional unblinding discussion from earlier.

如果可以的話，我只想就先前關於功能揭盲的討論提出一個後續問題。

I'm just curious, particularly with the Voyage trial, just the importance of showing a dose response and also just as far as the 40-week extension and I guess, kind of the long-term follow-up data.

我只是很好奇，特別是在 Voyage 試驗中，顯示劑量反應的重要性，以及 40 週的延長，我想，這是一種長期的追蹤數據。

Can you talk about how this data could help in just in terms of sort of addressing that question around functional unblinding and any other bias?

您能否談談這些數據如何幫助解決有關功能揭盲和其他偏見的問題？

Yes.

是的。

So I think the functional unblinding coming -- again functional unblinding will occur.

所以我認為功能性揭盲即將到來——功能性揭盲將再次發生。

It occurs in every psychiatry trial, certainly with drugs with a clear perceptual effect.

它出現在每一次精神科試驗中，當然也出現在具有明顯感知效應的藥物中。

We have -- I don't think anyone in the field really believes that for patients who take the active dose of drug that there's a likelihood that they will have no idea on average.

我們有—我認為該領域的任何人都不會真正相信對於服用有效劑量藥物的患者來說，他們很可能平均一無所知。

What we try to do is use these complementary designs across the program so that we're addressing to questions comprehensively across the full program, but also within individual studies.

我們嘗試在整個專案中使用這些互補的設計，以便我們能夠全面地解決整個專案中的問題，同時也能解決個別研究中的問題。

What we established with statistical and clinical significance in the Phase 2 study was that we have a dose response, and that dose response indicated moving forward with 100-microgram dose, which we're taking into Phase 3.

我們在第 2 階段研究中確定的具有統計學和臨床意義的結果是，我們有一個劑量反應，並且該劑量反應表明我們將以 100 微克的劑量繼續進行，並將其帶入第 3 階段。

We also saw that the pairwise comparison has demonstrated statistical significance of the 100-microgram group versus placebo.

我們也看到，成對比較顯示 100 微克組與安慰劑組相比具有統計意義。

So we are very confident that we have rigorously established the dose response of MM120.

因此，我們非常有信心我們已經嚴格確定了 MM120 的劑量反應。

Now as we go forward, the lower dose being used in Panorama, our second Phase 3 study -- I'm getting a little background there -- but lower dose being used as a secondary control in Panorama is really intended to confuse someone.

現在，隨著我們的進展，在 Panorama 中使用較低的劑量，這是我們的第二階段 3 期研究 - 我了解了一些背景資訊 - 但在 Panorama 中使用較低劑量作為二級對照實際上是為了混淆視聽。

Entering the study may have an expectancy, but by knowing that the lower dose is there, that a dose that is clearly perceivable, but we've shown in Phase 2 is clinically not active, that that would mitigate the connectivity between it and the expectancy bias and these clinical outcomes, which is mediated by functional unblinding.

進入研究可能會有期望，但透過了解較低的劑量，可以清楚感知的劑量，但我們在第 2 階段已表明其在臨床上無效，這將減輕它與期望偏差和這些臨床結果之間的聯繫，這是由功能揭盲介導的。

And so doing it, it aims to increase the integrity of the view, again, across the program.

這樣做的目的是再次提高整個程式視圖的完整性。

Now we've already done that in Phase 2.

現在我們已經在第二階段完成了這項工作。

So there, again, we feel highly confident that based on the Phase 2 data, we are seeing a response that is not simply driven by functional and binding at the end of the day, have three studies with different allocation ratios and different controls that seek to build a body of evidence across that full program that we're seeing a true drug effect.

因此，我們再次非常有信心，基於第 2 階段的數據，我們看到的反應不僅僅是由功能性和結合性驅動的，最終有三項研究採用了不同的分配比率和不同的控制，旨在在整個項目中建立證據體系，以證明我們看到了真正的藥物效果。

But certainly, what we've observed to date, we feel is the best data available to anyone in the field to support that conclusion, and we'll continue building on that in the Phase 3 program.

但可以肯定的是，我們認為迄今為止的觀察是該領域任何人都可以獲得的支持該結論的最佳數據，並且我們將在第三階段計劃中繼續以此為基礎。

Jason McCarthy, Maxim Group.

傑森·麥卡錫（Jason McCarthy），馬克西姆集團（Maxim Group）。

This is Michael Okunewitch on.

這是 Michael Okunewich。

So I guess just one for me, I'd like to ask a little bit with Compass' data delay, is there any added risk on the delivery side since we're no longer likely to have another long-acting psychedelic approved and on the market significantly ahead of MM120 to drive that expansion of the delivery infrastructure?

所以我想問一下，對於 Compass 的數據延遲，由於我們不太可能再有另一種長效迷幻藥獲得批准並在 MM120 之前投放市場來推動交付基礎設施的擴展，因此在交付方面是否存在額外的風險？

Yes.

是的。

Thanks for the question, Michael.

謝謝你的提問，麥可。

So we're extremely excited and confident to be shaping this market and believe as we've been able to execute in the clinical development programs, that our team's ability to again set the standard for the field in terms of real-world delivery is something we'll be pursuing.

因此，我們非常高興和有信心塑造這個市場，並相信，隨著我們能夠在臨床開發計劃中執行，我們的團隊有能力在現實世界的交付方面再次為該領域樹立標準，這是我們將追求的目標。

And that's something that we'll be pursuing regardless of what else happens with other programs or other organizations.

無論其他專案或組織發生什麼情況，我們都會繼續追求這個目標。

But certainly, as we progress here, we're very eager to continue those engagements with sites and payers and all the key stakeholders and to again set the standard for the field.

但可以肯定的是，隨著我們在這裡取得進展，我們非常渴望繼續與網站、付款人以及所有關鍵利益相關者進行合作，並再次為該領域樹立標準。

Do you anticipate that having no psychotherapy components could potentially broaden the number of delivery settings that you're able to go into?

您是否預計，沒有心理治療組件可能會擴大您能夠進入的分娩環境的數量？

It was certainly a driver of making that decision, both for the integrity of how we deliver and the interpretability of clinical results, but also to try to maximize access we can have for patients at the end of the day.

這無疑是做出該決定的驅動因素，不僅為了我們提供服務的完整性和臨床結果的可解釋性，也為了盡量最大限度地為患者提供治療。

So the delivery modality, what we are pursuing and how we deliver MM120 is intentional, it's by design and it's intended to maximize the opportunity for patient access to have a broad impact on the trajectory of these disorders.

因此，我們所追求的交付方式以及交付 MM120 的方式都是有意為之，是經過設計的，目的是最大限度地增加患者獲得治療的機會，從而對這些疾病的發展軌跡產生廣泛的影響。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

In your GAD trials, could you remind us in the open-label 40-week extension program, how will you maintain the integrity of the durability of effect that may be attributable solely to MM120 versus other medications that might be used?

在您的 GAD 試驗中，您能否提醒我們，在開放標籤的 40 週延長計劃中，與其他可能使用的藥物相比，您將如何保持可能僅歸因於 MM120 的效果持久性的完整性？

Yes.

是的。

I'll turn that one over to Dan.

我將把這個交給丹。

Thanks for the question, Sumant.

謝謝你的提問，Sumant。

The extension phase of these trials will have the same restriction on con-meds as the double-blind period because we're making additional treatment available to folks who need it.

這些試驗的延長階段將對合併用藥有與雙盲期相同的限制，因為我們正在為需要的患者提供額外的治療。

We think that given that it's an open-label treatment that it's not randomized, there will be no real drive for participants to go back onto prohibited con-meds.

我們認為，鑑於這是一種開放標籤治療，並非隨機的，因此參與者不會真正有動力重新使用禁止的藥物。

So same controls as we used for the first portion.

因此，我們採用的控制與我們第一部分相同。

Got it.

知道了。

And then in the -- I guess, if you want to map this out to the real world, what level of rescue therapy that does not involve redosing with MM120, if any, might be considered to be optimal in a clinical trial setting.

然後——我想，如果您想將其映射到現實世界，那麼在臨床試驗環境中，哪種程度的救援治療不涉及使用 MM120 重新給藥（如果有的話）可能被認為是最佳的。

So if I'm following the question you're asking, if someone was not adequately responding to MM120, what else could they be given?

所以如果我按照你的問題來問的話，如果有人對 MM120 沒有充分反應，他們還能得到什麼呢？

Is that the question?

這是問題嗎？

Yes, exactly.

是的，確實如此。

That and how many of those kinds of events would you expect?

您期望發生多少這樣的事件？

Clearly, there's always going to be some responders, non-responders, all of that.

顯然，總是會有一些響應者，有些不響應者，諸如此類。

But if someone does respond and then needs rescue, how do you characterize all that?

但如果有人確實做出了反應並且需要救援，您會如何描述這一切？

Yes.

是的。

So the upshot of that Part B extension phase is that if someone responds and then subsequently loses response, they can get up to four open-label treatments during that 40-week period.

因此，B 部分延長階段的結果是，如果有人對治療產生反應，隨後又失去反應，他們可以在 40 週期間接受最多四次開放標籤治療。

So the first step would be redosing and seeing if that captures and keeps people well.

因此，第一步是重新給藥，看看是否能捕捉並保持人們的健康。

There are in any trial going to be people who don't respond, right?

在任何試驗中都會有人不作出反應，對嗎？

No matter how good your drug is, it doesn't treat everybody, and it doesn't treat everybody completely.

無論藥物有多好，它都無法治愈所有人，也無法完全治愈所有人。

So if participants are not responding and ultimately are uncomfortable and have illness that's severe enough that they need to try something else, then they're withdrawn from the study at some point.

因此，如果參與者沒有反應，最終感到不舒服，並且病情嚴重到需要嘗試其他方法，那麼他們會在某個時候退出研究。

And we use statistical methods to fill them for the missing data after they leave the study.

在他們離開研究後，我們用統計方法填補缺失的數據。

So that's a decision that is made by IPAs along with of course, the participants themselves.

所以這是 IPA 和參與者自己做的決定。

But certainly, the hope is that by having these open-label treatment options that folks are able to stay in for the whole study.

但可以肯定的是，希望透過這些開放標籤的治療方案，人們能夠參與整個研究。

Thank you.

謝謝。

I am showing no further questions.

我沒有其他問題。

Thank you for your participation in today's conference.

感謝大家參加今天的會議。

This does conclude the program.

該計劃確實結束了。

You may now disconnect.

您現在可以斷開連線。