Mind Medicine (MindMed) Inc (MNMD) 2023 Q1 法說會逐字稿

Good afternoon, and welcome to the Mind Medicine first quarter 2023 financial results and corporate update conference call. (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.

下午好，歡迎參加 Mind Medicine 2023 年第一季度財務業績和公司更新電話會議。 （操作員說明）本次電話會議正在 MindMed 網站 Mindmed.co 的投資者和媒體部分進行網絡直播，電話會議結束後將提供錄音。

For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

在開場致辭中，我想介紹 MindMed 首席執行官 Rob Barrow。請繼續。

Thank you, and good afternoon, everyone. Welcome to our first quarter 2023 financial results and corporate update conference call. The press release reporting our financial results is available on the investors and media section of MindMed's website and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, will be filed today with the Securities and Exchange Commission.

謝謝大家，大家下午好。歡迎參加我們的 2023 年第一季度財務業績和公司更新電話會議。報告我們財務業績的新聞稿可在 MindMed 網站的投資者和媒體部分獲取，我們將於今天向美國證券交易委員會提交截至 2023 年 3 月 31 日的季度 10-Q 表格季度報告。

Joining me today is Schond Greenway, our Chief Financial Officer; Dr. Dan Karlin, our Chief Medical Officer; and Dr. Miri Halperin Wernli, our Executive President.

今天加入我的是我們的首席財務官 Schond Greenway； Dan Karlin 博士，我們的首席醫療官；以及我們的執行總裁 Miri Halperin Wernli 博士。

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; financial projections and our future expectation; plans, partnerships, and prospects. These statements are subject to various risks such as changes in market conditions, difficulties associated with research and development, and regulatory approval processes that are described in the filings made with the SEC, including the most recent annual report on Form 10-K and quarterly report on Form 10-Q.

在今天的電話會議中，我們將做出某些前瞻性聲明，包括但不限於有關我們候選產品的潛在安全性、有效性、監管和臨床進展的聲明；財務預測和我們的未來預期；計劃、合作夥伴關係和前景。這些聲明受到各種風險的影響，例如市場狀況的變化、與研發相關的困難以及向 SEC 提交的文件中描述的監管審批流程，包括最新的 10-K 表格年度報告和季度報告表格 10-Q 上。

Forward-looking statements are based on the assumptions, opinions, and estimates of management at the date the statements are made, including the non-recurrence of the risks and the uncertainties that are described in the filings made with the SEC or other significant events occurring outside of MindMed's formal course of business.

前瞻性陳述基於管理層在做出陳述之日的假設、意見和估計，包括向 SEC 提交的文件中描述的風險和不確定性不會再次發生或發生的其他重大事件MindMed 的正式業務範圍之外。

You're cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 4, 2023. MindMed disclaims any obligation to update such statements even if management's views change, except as required by law.

請您注意不要過分依賴這些截至 2023 年 5 月 4 日發布的前瞻性陳述。即使管理層的觀點發生變化，MindMed 也不承擔更新此類陳述的義務，除非法律要求。

I would like to begin by reiterating our deep commitment to advancing our organization and delivering new life-changing treatment options to the many individuals living with brain health disorders. As we pursue our strategy to bring our lead product candidate to market, we believe we are laying the foundation to create lasting value for our shareholders.

首先，我想重申我們對發展我們的組織並為許多患有大腦健康疾病的人提供改變生活的新治療方案的堅定承諾。當我們追求將我們的領先候選產品推向市場的戰略時，我們相信我們正在為股東創造持久價值奠定基礎。

In the first few months of 2023, we continue to make steady progress across our pipeline, and we are well positioned to execute on our key priorities or reach multiple milestones throughout this year, including data readouts from our Phase 2b trial of MM-120 which is treatment of generalized anxiety disorder or GAD, as well as from our Phase 2a proof-of-concept trial of repeated low dose MM-120 in attention deficit hyperactivity disorder or ADHD. In addition, we expect to initiate the first clinical trial of MM-402 later in the year.

在 2023 年的前幾個月，我們的產品線繼續取得穩步進展，我們已做好充分準備，可以執行我們的關鍵優先事項或在今年實現多個里程碑，包括從我們的 MM-120 2b 期試驗中讀出的數據，是治療廣泛性焦慮症或 GAD 的藥物，以及我們重複低劑量 MM-120 治療注意力缺陷多動障礙或 ADHD 的 2a 期概念驗證試驗。此外，我們預計將在今年晚些時候啟動 MM-402 的首次臨床試驗。

Before we dive further into our R&D and financial updates, I'd like to highlight the recently presented positive topline data. From the Phase 2 double-blind, investigator-initiated trial evaluating lysergide in the treatment of major depressive disorder or MDD. This trial was led by Professor Matthias Liechti and Dr. Felix Mueller, our collaborators at University Hospital Basel or UHB, and the University Hospital of Psychiatry in Switzerland.

在我們進一步深入研究研發和財務更新之前，我想強調一下最近公佈的積極的頂線數據。來自研究者發起的 2 期雙盲試驗，評估麥角酰麥角苷治療重度抑鬱症或 MDD 的效果。這項試驗由 Matthias Liechti 教授和 Felix Mueller 博士領導，他們是我們在巴塞爾大學醫院或 UHB 以及瑞士精神病學大學醫院的合作者。

As a reminder, we have exclusive global rights to data, compounds, and patents associated with Liechti Lab's research evaluating lysergide and other psychedelic compounds. This includes data from numerous completed and ongoing investigator-initiated trials in both healthy volunteers and patient populations. Our collaboration has been particularly impactful by demonstrating and reinforcing the clinical potential of our drug development pipeline.

謹此提醒，我們擁有與 Liechti Lab 評估麥角酰麥角和其他致幻化合物的研究相關的數據、化合物和專利的全球獨家權利。這包括來自許多已完成和正在進行的研究者發起的健康志願者和患者群體試驗的數據。我們的合作通過展示和加強我們藥物開發管道的臨床潛力而特別具有影響力。

Topline data from this investigator-initiated trial demonstrated significant rapid, durable, and beneficial effects of lysergide which potentially mitigate symptoms of MDD. Patients in this study received the 100-microgram dose of lysergide on the first dosing day, and the 200-microgram dose of lysergide in the second dosing date, which was separated by four weeks. An active small dose of 25 microgram of lysergide was used as a controller.

這項由研究者發起的試驗的主要數據表明，麥角酰甘油具有顯著的快速、持久和有益的作用，有可能減輕 MDD 的症狀。該研究中的患者在第一個給藥日接受 100 微克劑量的麥角酰二甲胺，並在第二個給藥日接受 200 微克劑量的麥角酰二乙胺，兩者相隔四個星期。使用活性小劑量的 25 微克麥角酰甘油作為控製劑。

The trial met its primary endpoint at six weeks, which was measured by the change in clinician-rated inventory of depressive symptomatology for IBS-C scores. Further, the statistic that was maintained at 16 weeks, which underscores the potential long-term benefit to license our treatment. Data from the secondary endpoints were also encouraging, and the investigational drug was generally well tolerated. Given the high degree of comorbidity of MDD and GAD, the positive results in clinical activity of lysergide are particularly relevant to our MM-120 program.

該試驗在六週後達到了主要終點，這是通過臨床醫生評定的 IBS-C 抑鬱症狀清單的變化來衡量的。此外，統計數據維持在 16 週，這強調了獲得我們的治療許可的潛在長期利益。次要終點的數據也令人鼓舞，研究藥物總體耐受性良好。鑑於 MDD 和 GAD 的高度合併症，麥角酰甘油臨床活性的積極結果與我們的 MM-120 項目特別相關。

I'll now turn to updates on our R&D programs, starting with our lead program, MM-120, a proprietary pharmaceutically optimized form of lysergide d-tartrate on development for the treatment of GAD and ADHD. GAD is an often-debilitating mental health disorder associated with excessive anxiety and persistent worry, which can lead to significant impairment in social, occupational, and other functioning. With very little innovation focused on treatment of GAD, there has been a notable increase in the incidence and prevalence of individuals diagnosed with GAD in the US and Europe over the past several years.

我現在將介紹我們研發項目的最新情況，首先是我們的主導項目 MM-120，這是一種經過專利藥物優化的 d-酒石酸麥角酰麥角酸形式，正在開髮用於治療廣泛性焦慮症 (GAD) 和注意力缺陷多動症 (ADHD)。廣泛性焦慮症是一種經常使人衰弱的精神健康障礙，與過度焦慮和持續擔憂有關，可能導致社交、職業和其他功能的嚴重損害。由於針對廣泛性焦慮症治療的創新很少，過去幾年，美國和歐洲被診斷患有廣泛性焦慮症的個體的發病率和患病率顯著增加。

Additionally, the number of patients who were not adequately treated by available therapies are increasing. This is a result of the low rate of remission in multiple safety and tolerability challenges of SSRIs, SNRIs, antipsychotics, and benzodiazepines.

此外，未得到現有療法充分治療的患者數量正在增加。這是由於 SSRIs、SNRIs、抗精神病藥和苯二氮卓類藥物在多重安全性和耐受性挑戰中緩解率較低的結果。

The research we've conducted with patients and healthcare practitioners in the US and Europe tells us that there's a significant demand for a new pharmacological class that would offer faster, more profound, and more durable efficacy responses, as well as favorable safety and tolerability. This is particularly true in the segment of patients who, despite having exhausted all available options, continue to experience intolerable anxiety.

我們對美國和歐洲的患者和醫療保健從業人員進行的研究告訴我們，對新的藥理學類別的需求很大，這種藥物可以提供更快、更深刻、更持久的療效反應，以及良好的安全性和耐受性。對於儘管已經用盡所有可用選擇，但仍繼續經歷難以忍受的焦慮的患者來說尤其如此。

Given the need for new treatment options, were extremely encouraged by the growing data, which supports the therapeutic potential of MM-120. Patient dosing and enrollment for our Phase 2b trial in GAD is progressing well across our 20 active sites, and we reiterate our expectation of reporting topline results in late 2023. The trial plans to enroll a total of 200 participants who will receive a single administration of up to 200 micrograms of MM-120 or a placebo.

鑑於對新治療方案的需求，不斷增長的數據極大地鼓舞了 MM-120 的治療潛力。我們在 GAD 的 2b 期試驗的患者給藥和入組在我們的 20 個活躍中心進展順利，我們重申我們期望在 2023 年末報告主要結果。該試驗計劃總共招募 200 名參與者，他們將接受單次給藥最多 200 微克 MM-120 或安慰劑。

The primary objective of the study is to determine the reduction and anxiety symptoms for up to 12 weeks after a single administration of MM-120 across five treatment arms, where the primary endpoint measured at four weeks post dosing. The results of this trial will guide dose selection development strategy for MM-120 in GAD, as well as deepen our scientific understanding of its clinical effects with underlying functional mechanisms of action.

該研究的主要目的是確定五個治療組單次施用 MM-120 後長達 12 週的緩解和焦慮症狀，其中主要終點在給藥後 4 週測量。該試驗的結果將指導 MM-120 在 GAD 中的劑量選擇開發策略，並加深我們對其臨床效果及其潛在功能作用機制的科學理解。

As mentioned, we are also evaluating MM-120 for ADHD and we expect to report topline data for our Phase 2a trial in late 2023. Our Phase 2a trial is being conducted in collaboration with the University Hospital Basel in Switzerland and Maastricht University in the Netherlands and is designed to evaluate the therapeutic utility of repeated low doses of MM-120 in adult patients with ADHD.

如前所述，我們還在評估 MM-120 治療 ADHD 的效果，並預計在 2023 年末報告 2a 期試驗的主要數據。我們的 2a 期試驗是與瑞士巴塞爾大學醫院和荷蘭馬斯特里赫特大學合作進行的旨在評估重複低劑量 MM-120 對成年 ADHD 患者的治療效用。

Notably, this is the first study in which MM-120 has been administered outside of clinical setting. To date, no SAEs have been reported to get from the real-world potential of this treatment regimen as well as demonstrating our ability to deliver MM-120 with innovative dose and frequency combinations.

值得注意的是，這是第一項在臨床環境之外施用 MM-120 的研究。迄今為止，尚未有報導稱該治療方案在現實世界中具有潛力，並且證明了我們以創新劑量和頻率組合提供 MM-120 的能力。

In this trial, we expect to enroll a total of 52 participants who will receive a 20-microgram dose of MM-120 or placebo twice weekly for six weeks. The primary endpoint to the study or mean change from baseline in ADHD symptoms and assessed by the AISRS for six weeks of treatment.

在這項試驗中，我們預計總共招募 52 名參與者，他們將每週兩次接受 20 微克劑量的 MM-120 或安慰劑，持續六週。研究的主要終點或 ADHD 症狀相對於基線的平均變化，並由 AISRS 評估六周治療時間。

This proof-of-concept trial is a component of our broader comprehensive MM-120 clinical development strategy, which seeks to explore both session-based administration that harnesses perceptual effects of serotonin agonism, an innovative repeat administration regimen that harvest a neuropharmacological effects of the current serotonin agonism. The innovation of MM-120 and its session-based delivery approach is driven by its mechanism of action as a potent serotonin receptor agonist, which leads to profound sustained psychological effects.

這項概念驗證試驗是我們更廣泛的綜合 MM-120 臨床開發戰略的一部分，該戰略旨在探索利用血清素激動的感知效果的基於會話的給藥方案，以及一種創新的重複給藥方案，該方案收穫了當前的血清素激動。 MM-120 的創新及其基於會話的遞送方法是由其作為有效血清素受體激動劑的作用機制驅動的，這會導致深遠的持續心理影響。

We believe MM-120 will be delivered as a single-dose pharmacological intervention that will only require occasional administration. We recognize the potential challenges in commercializing our product with such a revolutionary delivery profile and have embarked on a robust pre-commercialization plan seeking to educate all external stakeholders of the clinical and economic value of MM-120. This is why one of the key priorities we are advancing in 2023 is to develop an innovative market access strategy, document the clinical and socioeconomic burden of GAD and ADHD, and advance the generation of health economics and outcomes research data required to build a superior value proposition for our product candidates.

我們相信 MM-120 將作為單劑量藥物干預提供，只需要偶爾給藥。我們認識到以如此革命性的交付方式將我們的產品商業化的潛在挑戰，並已開始實施強有力的預商業化計劃，旨在讓所有外部利益相關者了解 MM-120 的臨床和經濟價值。這就是為什麼我們在 2023 年推進的關鍵優先事項之一是製定創新的市場准入戰略，記錄 GAD 和 ADHD 的臨床和社會經濟負擔，並促進構建卓越價值所需的健康經濟學和結果研究數據的生成為我們的候選產品提出建議。

As we progress our pipeline, we look forward to providing greater clarity on the commercial model and path forward for each program to maximize the reach of our novel product candidates.

隨著我們管道的進展，我們期待為每個項目提供更清晰的商業模式和前進道路，以最大限度地擴大我們的新穎候選產品的覆蓋範圍。

As a reminder, with respect to our intellectual property strategy, our patent portfolio includes 26 pending US applications and 12 pending PCT applications. These include applications covering compositions, dosing, dosage formulations, and methods of treatment, among others, with projected expiration dates beginning in 2041. Additionally, we continue to retain all rights to our product candidates and are aggressively protecting and expanding our intellectual property portfolio as part of our comprehensive market protection strategy.

提醒一下，就我們的知識產權戰略而言，我們的專利組合包括 26 項待審的美國申請和 12 項待審的 PCT 申請。其中包括涵蓋組合物、劑量、劑量配方和治療方法等的應用，預計有效期從 2041 年開始。此外，我們繼續保留對我們的產品候選者的所有權利，並積極保護和擴大我們的知識產權組合我們全面的市場保護戰略的一部分。

Now I would like to turn to MM-402 or R(-)-MDMA, which is a synthetic enantiomer of MDMA with potential pro-social effects and a favorable tolerability profile. MM-402 is development for the treatment of core symptoms of autism spectrum disorder or ASD which is characterized by atypical social communication and interaction, repetitive patterns of behavior, and restrictive interest. Despite a significant and growing prevalence, there are no therapies approved to treat the core symptoms of ASD.

現在我想談談 MM-402 或 R(-)-MDMA，它是 MDMA 的合成對映體，具有潛在的親社會效應和良好的耐受性。 MM-402是為治療自閉症譜系障礙或ASD的核心症狀而開發的，其特點是非典型的社會溝通和互動、重複的行為模式和限制性興趣。儘管自閉症譜系障礙的患病率顯著且不斷增長，但目前還沒有批准治療自閉症譜系障礙核心症狀的療法。

MDMA is a synthetic module. It is often referred to as [empathage] because it is reported to increase feelings of connectedness and compassion. R(-)-MDMA is sought to increase levels of serotonin and to a lesser extent, neuro epinephrine and other neurotransmitters in the brain resulting in feelings of increased social mobility and interpersonal emotional warrant.

MDMA 是一種合成模塊。它通常被稱為“同理心”，因為據報導它可以增加聯繫感和同情心。 R(-)-MDMA 旨在增加大腦中血清素的水平，並在較小程度上增加神經腎上腺素和其他神經遞質的水平，從而增加社會流動性和人際情感保證的感覺。

Preclinical studies of R(-)-MDMA demonstrate its acute prosocial and pathogenic effect, whilst diminished dopaminergic activity suggested it can exhibit less stimulus activity, neurotoxicity, hyperthermia, and abuse liability risk compared to racemic MDMA or the s-enantiomer. Our aim for MM-402 is to demonstrate its ability to enhance social engagement and interaction rather than having a sedating or blunting effect, which is often a result of currently used off-label medications in the ASD population.

R(-)-MDMA 的臨床前研究證明了其急性親社會和致病作用，同時多巴胺能活性的減弱表明，與外消旋 MDMA 或 s-對映體相比，它的刺激活性、神經毒性、體溫過高和濫用風險較低。我們對 MM-402 的目標是證明其增強社交參與和互動的能力，而不是具有鎮靜或鈍化作用，這通常是目前自閉症譜系障礙人群中使用標籤外藥物的結果。

Importantly, a late breaking abstract on a preclinical study of MM-402 in the model of ASD has been accepted for presentation at the 2023 American Society of Clinical Psychopharmacology annual meeting, which is being held in Miami Beach, Florida from May 30th to June 2nd.

重要的是，關於 MM-402 在 ASD 模型中進行的臨床前研究的最新摘要已被接受在 2023 年美國臨床精神藥理學會年會上發表，該年會將於 5 月 30 日至 6 月 2 日在佛羅里達州邁阿密海灘舉行。

With even further preclinical evidence to support our approach, we are extremely excited to initiate our Phase 1 clinical trial in MM-402 later this year. The trial is intended to characterize the tolerability, pharmacokinetics, and pharmacodynamics of MM-402, and we continue to explore all opportunities to generate early signs of efficacy as early as possible in development. We anticipate such data can be generated both in neurotypical healthy volunteers and in otherwise, healthy individuals diagnosed with ASD.

有了進一步的臨床前證據支持我們的方法，我們非常高興能在今年晚些時候啟動 MM-402 的 1 期臨床試驗。該試驗旨在表徵 MM-402 的耐受性、藥代動力學和藥效學，我們將繼續探索所有機會，以便在開發過程中儘早產生早期療效跡象。我們預計這些數據可以在神經正常的健康志願者和被診斷患有自閉症譜系障礙的健康個體中產生。

In parallel to our research collaboration with University Hospital Basel, in 2022, we initiated and are currently enrolling healthy volunteers in a comparative Phase 1, pharmacokinetics and pharmacodynamics study of R, S, and racemic MDMA. This study is designed to evaluate the tolerability, pharmacokinetics, and acute subjective physiological and endocrine effects of the three molecule. We believe a successful completion will accelerate our understanding of the pharmacological profile and then forward to as we advance into later-stage clinical development.

在與巴塞爾大學醫院開展研究合作的同時，我們於 2022 年啟動並正在招募健康志願者參與 R、S 和外消旋 MDMA 的藥代動力學和藥效學比較 1 期研究。本研究旨在評估這三種分子的耐受性、藥代動力學以及急性主觀生理和內分泌效應。我們相信，成功完成將加速我們對藥理學特徵的理解，然後隨著我們進入後期臨床開發。

Lastly, moving to our digital medicine update. Our drug development strategy is closely complemented by a suite of digital medicine programs that have the potential to facilitate adoption, use, and access to our product candidates. By refining the techniques used to capture, model, and map the autonomic and behavioral outflow in other correlates to neuro activity. We do improve the experience of clinicians on the outcomes for patients and the delivery of psychedelics and other perception-altering substances.

最後，轉向我們的數字醫學更新。我們的藥物開發戰略得到了一系列數字醫學項目的密切補充，這些項目有可能促進我們候選產品的採用、使用和獲取。通過改進用於捕獲、建模和映射與神經活動相關的其他自主神經和行為流出的技術。我們確實改善了臨床醫生在患者治療結果以及迷幻藥和其他感知改變物質的給藥方面的經驗。

Our digital medicine programs are oriented toward applications during two primary clinical period. Activity during the treatment session referred to as intra session, and activities between treatment session referred to as inter session. Each digital medicine program consists of a platform that contains separate underlying components, some of which we anticipate will be within the scope of FDA's definition of medical devices and others, which we anticipate will not be regulated as medical devices.

我們的數字醫學項目面向兩個主要臨床階段的應用。治療期間的活動稱為療程內，治療期間之間的活動稱為療程間。每個數字醫學項目都由一個平台組成，該平台包含單獨的底層組件，我們預計其中一些組件將在 FDA 醫療設備定義的範圍內，而其他組件我們預計將不會作為醫療設備進行監管。

For the medical device products, we intend to engage with the FDA and other international regulatory authorities to receive guidance along the development pathway towards a potential submission for regulatory clearance or approval. The ultimate goal of our digital medicine projects is to develop applications that overcome frictional point of care delivery to encourage user adoption across patients, providers, and payers.

對於醫療器械產品，我們打算與 FDA 和其他國際監管機構合作，以獲得開發路徑方面的指導，以便可能提交監管許可或批准。我們數字醫療項目的最終目標是開發能夠克服護理交付摩擦點的應用程序，以鼓勵患者、提供者和付款人之間的用戶採用。

Overall, we are very pleased with the progress to date. As we advance our key clinical programs and execute on our corporate objectives, we continue to further strengthen the leadership of MindMed. We're very excited by the recent addition of Mark R. Sullivan, the Chief Legal Officer, Corporate Secretary. Mark brings extensive legal and public company life sciences expertise with a strong addition to our executive team. We believe Mark's experience, insight, and guidance will proven valuable as we progress to the next stage of MindMed evolution.

總的來說，我們對迄今為止的進展感到非常滿意。隨著我們推進關鍵臨床項目並執行我們的企業目標，我們將繼續進一步加強 MindMed 的領導地位。我們對首席法律官兼公司秘書 Mark R. Sullivan 最近的加入感到非常興奮。馬克為我們的執行團隊帶來了廣泛的法律和上市公司生命科學專業知識，並為我們帶來了強大的補充。我們相信，隨著我們進入 MindMed 發展的下一階段，Mark 的經驗、洞察力和指導將被證明是有價值的。

I'd also like to highlight that as we approach our annual meeting in June, we are very excited by the potential of adding Dave Gryska to our Board. Dave brings invaluable insights from his 35 years of experience in the biopharmaceutical industry, including his service as CFO of two S&P 500 pharmaceutical companies, Incyte and Celgene. Dave has also previously served on the Board of GW Pharmaceuticals before its acquisition by Jazz Pharmaceuticals for $7.2 billion; and serves on the Board of Seagen, which recently agreed to be acquired by Pfizer for over $43 billion.

我還想強調的是，隨著六月年會的臨近，我們對戴夫·格里斯卡 (Dave Gryska) 加入董事會的潛力感到非常興奮。 Dave 從他在生物製藥行業 35 年的經驗中帶來了寶貴的見解，包括他擔任兩家標準普爾 500 強製藥公司 Incyte 和 Celgene 的首席財務官。在被 Jazz Pharmaceuticals 以 72 億美元收購之前，Dave 還曾在 GW Pharmaceuticals 的董事會任職；並在 Seagen 董事會任職，該公司最近同意被輝瑞以超過 430 億美元的價格收購。

Dave's nomination represents our ongoing commitment to Board refreshment and ensuring we have the optimal mix of experience and perspectives in the Board room to help the company create value. Adding Dave involvement is an endorsement of the incredible people and organization we have built at MindMed as well as the potential impact of our product from the millions of individuals suffering from brain health disorders.

戴夫的提名代表了我們對董事會更新的持續承諾，並確保我們在董事會中擁有經驗和觀點的最佳組合，以幫助公司創造價值。 Dave 的加入是對我們在 MindMed 建立的令人難以置信的人員和組織的認可，也是對我們產品對數百萬患有大腦健康疾病的人的潛在影響的認可。

I'd also like to express the Board's gratitude to Brigid Makes who notified us that she will not stand for reelection at the annual meeting for her years of service to the early growth of the organization. Now is the time to radically transform how we treat brain health disorders, and we are deeply committed to realizing that potential for change.

我還要向董事會表示感謝 Brigid Makes，她通知我們，由於她多年來為組織的早期發展做出的貢獻，她將不再在年會上競選連任。現在是從根本上改變我們治療大腦健康疾病的方式的時候了，我們堅定地致力於實現這種改變的潛力。

With that, I will now turn the call over to our CFO, Schond Greenway, to discuss our financial results. Schond?

現在，我將把電話轉給我們的首席財務官 Schond Greenway，討論我們的財務業績。舍恩德？

Thanks, Rob, and thank you all for joining us today. We will now turn to our financial results for the first quarter ended March 31, 2023. As of March 31, 2023, our cash and cash equivalents totaled $129.4 million compared to $142.1 million as of December 31, 2022. We believe that our current cash and cash equivalents on hand positions us to accelerate our preparation for moving quickly into our pivotal studies for our lead program, MM-120, and will be sufficient to meet our operating requirements beyond our key development milestones in 2023 and into the first half of 2025.

謝謝羅布，也感謝大家今天加入我們。現在，我們將討論截至 2023 年 3 月 31 日的第一季度財務業績。截至 2023 年 3 月 31 日，我們的現金和現金等價物總額為 1.294 億美元，而截至 2022 年 12 月 31 日為 1.421 億美元。我們認為，我們當前的現金手頭的現金等價物使我們能夠加快準備工作，快速進入我們的主導項目 MM-120 的關鍵研究，並將足以滿足我們在 2023 年關鍵開發里程碑之後和 2025 年上半年的運營要求。

Our net cash used in operating activities was $13.3 million for the quarter ended March 31, 2023, compared to $12.9 million in the quarter ended March 31, 2022. Research and development expenses were $12.6 million for the quarter ended March 31, 2023, compared to $10.2 million for the quarter ended March 31, 2022, an increase of $2.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for the MM-120 GAD study, $0.9 million in expenses related to our MM-402 program, and $0.2 million in internal personnel cost as a result of increase in research and development capabilities, which were offset by a decrease of $0.7 million in expenses related to our MM-110 program and a decrease of $0.9 million in expenses in connection with various external R&D collaborations.

截至 2023 年 3 月 31 日的季度，我們用於經營活動的淨現金為 1,330 萬美元，而截至 2022 年 3 月 31 日的季度為 1,290 萬美元。截至 2023 年 3 月 31 日的季度，研發費用為 1,260 萬美元，而截至 2023 年 3 月 31 日的季度，研發費用為 1,260 萬美元。截至 2022 年 3 月 31 日的季度收入為 1,020 萬美元，增加了 240 萬美元。增加的主要原因是與 MM-120 GAD 研究臨床研究相關的費用增加了 290 萬美元，與我們的 MM-402 項目相關的費用增加了 90 萬美元，以及由於研究增加而導致的內部人員成本增加了 20 萬美元和開發能力，這被與 MM-110 項目相關的費用減少 70 萬美元以及與各種外部研發合作相關的費用減少 90 萬美元所抵消。

General and administrative expenses were $8.3 million for the quarter ended March 31, 2023, essentially flat compared to the same quarter a year ago. Our net loss for the three months ended March 31, 2023, was $24.8 million compared to $18.5 million for the same period in 2022.

截至 2023 年 3 月 31 日的季度一般及管理費用為 830 萬美元，與去年同期基本持平。截至 2023 年 3 月 31 日的三個月，我們的淨虧損為 2,480 萬美元，而 2022 年同期為 1,850 萬美元。

Lastly, I wish to reiterate that we are continuing to execute on a very efficient operation in terms of quarterly cash burn and headcount when compared to our peers in this space. As we have highlighted during our prior business update conference calls, we intend to continue to be thoughtful with our cash while also focusing and prioritizing our support for our most precious resource development activities, directed to our key value drivers. More specifically, we will review our discretionary expenses on a constant basis to ensure that we are seeking to capture value from operational efficiencies where we can.

最後，我想重申，與該領域的同行相比，我們在季度現金消耗和員工人數方面繼續執行非常高效的運營。正如我們在之前的業務更新電話會議上強調的那樣，我們打算繼續深思熟慮地使用我們的現金，同時重點關注和優先支持我們最寶貴的資源開發活動，針對我們的關鍵價值驅動因素。更具體地說，我們將不斷審查我們的可自由支配費用，以確保我們盡可能從運營效率中獲取價值。

I will now turn the call back to Rob, who will provide some closing comments.

我現在將把電話轉回給 Rob，他將提供一些結束語。

Thank you, Schond. We remain laser focused on driving our key program forward, which includes advancing our MM-120 product candidate in GAD and ADHD to Phase 2 clinical readouts later this year, as well as initiating our first clinical trial of MM-402. Additionally, our early R&D activities are progressing. Our collaboration with the University Hospital Basel continues to offer the opportunity to generate early clinical evidence to inform our pipeline progression.

謝謝你，舍恩德。我們仍然專注於推動我們的關鍵項目向前發展，其中包括將我們在 GAD 和 ADHD 領域的 MM-120 候選產品推進到今年晚些時候的 2 期臨床試驗，以及啟動 MM-402 的首次臨床試驗。此外，我們的早期研發活動正在取得進展。我們與巴塞爾大學醫院的合作繼續提供產生早期臨床證據的機會，以告知我們的管道進展。

I also want to extend my sincere appreciation and gratitude for the foundational work that brought us closer to advancing novel treatments for brain health disorders. In particular, I would like to thank our highly talented and deeply committed team here at MindMed, our investors, and the many people who have been supportive along the way, including our research participants and their families. We are working tirelessly to deliver on our mission of transforming the treatment landscape for the many individuals living with brain health disorders who are underserved by today's available therapies.

我還想對基礎工作表示誠摯的讚賞和感謝，這些工作使我們更接近於推進大腦健康疾病的新療法。我特別要感謝 MindMed 才華橫溢、高度奉獻的團隊、我們的投資者以及一路以來給予我們支持的許多人，包括我們的研究參與者及其家人。我們正在不懈努力，以實現我們的使命，即為許多患有腦部健康疾病的人改變治療格局，而這些人目前的可用療法服務不足。

Final, I'd like to remind everyone that the purpose of today's call is to discuss our first quarter updates on the progress of our business, and we will not be addressing matters related to our annual meeting. We encourage all of our shareholders to review our definitive proxy statement that's been filed with the SEC and on SEDAR, and visit www.protectmindmed.com for updates pertaining to our proxy campaign.

最後，我想提醒大家，今天電話會議的目的是討論我們第一季度的業務進展情況，我們不會討論與年會相關的事項。我們鼓勵所有股東查看我們向 SEC 和 SEDAR 提交的最終委託書，並訪問 www.protectmindmed.com 以獲取有關我們委託活動的最新信息。

With that, I'd like to thank you all again for joining today and I'm happy to take questions.

在此，我要再次感謝大家今天的加入，我很樂意回答問題。

(Operator Instructions) Charles Duncan, Cantor Fitzgerald.

（操作員說明）查爾斯·鄧肯、坎托·菲茨杰拉德。

Okay. Yes, good afternoon, Rob, Schond, thanks for taking my questions and also thanks for all of the clinical trial design details, particularly for 120 in ADHD and 402, that was helpful. I do have a couple of questions. So regarding of MM-120 in GAD, I'm wondering with a sample size of call it 200 of five arms, so about 40 per arm. I'm wondering if you could frame what you would like to see out of that study in terms of some of the effect sizes and if you anticipate a full kind of dose response or would it be really bookended by placebo versus the highest dose. So tell us what you think would be good out of that [for 20] or out of that 120 study in GAD. Thanks.

好的。是的，下午好，Rob、Schond，感謝您提出我的問題，也感謝所有臨床試驗設計細節，特別是針對 ADHD 的 120 和 402，這很有幫助。我確實有幾個問題。因此，關於 GAD 中的 MM-120，我想知道樣本大小為 200 個，共 5 個臂，因此每臂大約 40 個。我想知道您是否可以根據一些效應大小來製定您希望從該研究中看到的內容，以及您是否預期完整的劑量反應，或者它是否真的會被安慰劑與最高劑量所限制。那麼請告訴我們您認為 [20 人] 或 120 人的 GAD 研究中哪一項是好的。謝謝。

Thanks, Charles. Thanks for the question and for joining us today. With respect to the size and design of the Phase 2b study. So as you mentioned, 200 patients we're anticipating rolling across five treatment arms, which for everyone's, as a reminder, is doses of 25, 50, 100, or 200 micrograms or a placebo. Patients receive a single dose and they're followed for 12 weeks. The study was designed in such a way where statistical methodology we're using really gives us power across the entire spectrum. So we benefit from the response across the treatment.

謝謝，查爾斯。感謝您提出問題並今天加入我們。關於 2b 期研究的規模和設計。正如您提到的，我們預計 200 名患者將接受 5 個治療組的治療，提醒一下，每個人的劑量均為 25、50、100 或 200 微克或安慰劑。患者接受單劑治療並隨訪 12 週。這項研究的設計方式使我們使用的統計方法真正為我們提供了涵蓋整個範圍的力量。因此，我們可以從整個治療過程中的反應中受益。

That methodology is developed at Novartis, and it's something that -- also is a two-part statistical test, one that tests whether or not there is any treatment response at all. In the second part of the test is we nominate candidate profiles which would reflect exactly what you're getting to in terms of the type of dose response, the magnitude. That's actually the slope and the shape of that dose response curve.

該方法是諾華公司開發的，它也是一個由兩部分組成的統計測試，測試是否有任何治療反應。在測試的第二部分中，我們提名候選配置文件，該配置文件將準確反映您在劑量反應類型和幅度方面所獲得的結果。這實際上是劑量反應曲線的斜率和形狀。

In terms of the maximum magnitude we anticipate, seeing we've really designed the study so that we can characterize the effect size and power Phase 3 program. But our expectation was really set to demonstrate just anything at or above standard of care. It's the same as effect size for most available anxiolytics around 0.3 to 0.5, whether you look at the SSRIs or benzodiazepines. And so if we saw a response of that magnitude, we would anticipate seeing significant outcome. That said, we certainly want to see an improvement over the standard of care and believe there's opportunity to do exactly that.

就我們預期的最大幅度而言，我們確實設計了這項研究，以便我們能夠表徵第三階段計劃的效應大小和功效。但我們的期望確實是要展示任何達到或高於護理標準的東西。無論是 SSRIs 還是苯二氮卓類藥物，它與大多數可用的抗焦慮藥的效果大小相同，約為 0.3 至 0.5。因此，如果我們看到如此大的反應，我們預計會看到重大成果。也就是說，我們當然希望看到護理標準的改善，並相信有機會做到這一點。

So in terms of our expectations, we do want to fully characterize the response across the doses, both acutely and in terms of durability. I think it's particularly important to emphasize that by looking at multiple doses that we believe would be at or above or within the therapeutic window, that actually gives us important insights, both in terms of magnitude and durability of response at those different doses and the sub therapeutic doses as we anticipated. So design has been again to robustly power and detect the difference, but also to make sure we're characterizing adequate the acute and durable response to power and design our Phase 3 program.

因此，就我們的期望而言，我們確實希望全面描述不同劑量的反應，無論是敏銳的還是持久的。我認為特別重要的是要強調，通過觀察我們認為處於或高於或處於治療窗口內的多個劑量，這實際上為我們提供了重要的見解，無論是在這些不同劑量和亞劑量下反應的幅度和持久性方面。正如我們預期的治療劑量。因此，設計再次是為了穩健地供電並檢測差異，同時也是為了確保我們能夠充分錶徵對電力的敏銳和持久的響應，並設計我們的第三階段計劃。

Okay. So that's helpful, Rob. So we should not consider that this is a pivotal program -- or pivotal study and judge its outcome based on that, but that whether or not it's viable to help you move forward into Phase 3, correct?

好的。所以這很有幫助，羅布。因此，我們不應該認為這是一個關鍵計劃 - 或關鍵研究並據此判斷其結果，而應該考慮它是否可以幫助您進入第三階段，對嗎？

That's correct. It would be very much premature to consider this a pivotal study. It's certainly an important part. We've even seen presentation by representatives in FDA at recent conferences, particularly at ECMP a few weeks ago about the importance of demonstrating dose response. And again, I think we, as a sector setting this drug class, really need full comprehensive information and data sets before we go into a pivotal program is going to be very efficient, very clean design as we anticipate it today.

這是正確的。現在認為這是一項關鍵研究還為時過早。這當然是一個重要的部分。我們甚至在最近的會議上看到 FDA 代表的演講，特別是幾週前的 ECMP 上關於展示劑量反應的重要性的演講。再說一遍，我認為，作為製定該藥物類別的部門，我們確實需要全面全面的信息和數據集，然後才能進入關鍵計劃，該計劃將像我們今天所預期的那樣非常高效、非常簡潔的設計。

So it has been the study -- the Phase 2 study been designed to give important insights in that design, characterize the response in this population, which has not been done at this scale of this magnitude. And really no studies to date that we're aware of has looked at as comprehensive exploration of dose response.

因此，這就是這項研究——第二階段研究的目的是在該設計中提供重要的見解，描述該人群的反應特徵，而這種規模的研究尚未進行過。據我們所知，迄今為止還沒有任何研究對劑量反應進行全面探索。

So that is the intent of the study and ultimately, we believe that will give us both additional support for also the clinical package that we submitted an NDA, but also would help us be very efficient with our Phase 3 design.

這就是這項研究的目的，最終，我們相信這將為我們提交的 NDA 臨床方案提供額外的支持，同時也將幫助我們非常高效地進行 3 期設計。

Very good. And then one quick perspective builder on the recent CPT codes -- CPT III codes. I'm wondering if you could provide your perspective on how you think the AMA's recent, I guess, approval of -- first-step approval to establishing CPT code to enable really intermittent therapy that that involves both the drug and the therapist. If you have a perspective on that and how that may actually reduce the risk of not only approval but commercialization of these types of drugs. Thanks.

非常好。然後是最近 CPT 代碼的一個快速透視構建器——CPT III 代碼。我想知道您是否能提供您的觀點，您認為 AMA 最近批准了——我想，第一步批准建立 CPT 代碼，以實現涉及藥物和治療師的真正間歇性治療。如果您對此有看法，以及這如何實際上不僅可以降低這些類型藥物的批准風險，還可以降低商業化的風險。謝謝。

Thanks, Charles. I'll turn it over to Dan Karlin, our Chief Medical Officer, to respond on that one.

謝謝，查爾斯。我會將其轉交給我們的首席醫療官丹·卡林 (Dan Karlin)，他將對此做出回應。

Hi, Charles. Dan here. It's a really important question. Obviously, something we've been paying a lot of attention to as progress has been made in that CPT III code. As folks listening will know that the Level III codes is used for experimental and new services that have not yet declared approved as a substantial body of evidence behind yet.

嗨，查爾斯。丹在這裡。這是一個非常重要的問題。顯然，隨著 CPT III 代碼取得進展，我們一直非常關注這一點。聽過的人都知道，III 級代碼用於實驗性和新服務，這些服務尚未宣布獲得批准作為背後的大量證據。

Now we think this is a important step in the right direction and we applaud [Congress and master] the collaboration on getting to that point. But we also know that -- well, that code is specific to psychedelic services in general. It is a little applied to everybody across the Board. In many cases for existing parallel systems such as esketamine administration. While there is an existing [HFCTS] Level II code or G code specifically the services, many, if not most commercial insurers are actually being billed for services like this under existing Level I code.

現在我們認為這是朝著正確方向邁出的重要一步，我們對[國會和大師]為實現這一點而進行的合作表示讚賞。但我們也知道——嗯，該代碼通常是特定於迷幻服務的。它有點適用於整個委員會的每個人。在許多情況下，對於現有的並行系統，例如艾氯胺酮給藥。雖然現有的 [HFCTS] II 級代碼或 G 代碼專門用於服務，但許多（如果不是大多數）商業保險公司實際上是根據現有的 I 級代碼為此類服務付費的。

So there are a number of paths to cutting success and another through some official recognition from AMA and in the CPT is important. It's only one certainly on the process to having a fully robust coding system that will cover all forms of third-party payers, including government and non-governmental commercial payers.

因此，取得成功的途徑有很多，其中一條通過 AMA 和 CPT 的官方認可也很重要。這只是建立一個完全強大的編碼系統的過程中唯一的一個，該系統將覆蓋所有形式的第三方付款人，包括政府和非政府商業付款人。

That's helpful. Thanks for the added color again. Thanks for taking my questions.

這很有幫助。再次感謝您添加的顏色。感謝您回答我的問題。

Brian Abrahams, RBC Capital Markets.

布萊恩·亞伯拉罕斯 (Brian Abrahams)，加拿大皇家銀行資本市場部。

Hey, good afternoon. Thanks for taking my questions. Two from me. I guess first off on MM-120. As you think about how you might interpret the upcoming Phase 2 data, I'm curious your latest thoughts on how to find the best dosing window -- dose levels that are going to maximize the benefit risk profile. And I guess I'm curious if multiple doses are effective, would you move forward with two doses or more in Phase 3? And I guess how might you think about steering which dose might be appropriate for which patient in balancing efficacy with safety?

嘿，下午好。感謝您回答我的問題。我的兩個。我想首先是 MM-120。當您考慮如何解釋即將到來的第二階段數據時，我很好奇您對如何找到最佳劑量窗口（將最大化收益風險狀況的劑量水平）的最新想法。我想我很好奇如果多次劑量有效，您會在第三階段繼續注射兩次或更多劑量嗎？我想您會如何考慮控制哪種劑量適合哪種患者，以平衡療效和安全性？

Yeah. Thanks so much for the question, Brian. It will a little bit premature to say specifically -- and actually, that we have many thoughts about how we generally think about safety and efficacy and the balance of benefit risk as we design a Phase 3 program. What I would say is that we are very much intent on being extremely efficient and clean in our study design and want to make sure that we have as direct of a path as efficient of a program as possible.

是的。非常感謝你的提問，布萊恩。現在具體說還為時過早，實際上，在設計第 3 階段計劃時，我們對安全性、有效性以及利益風險平衡的總體看法有很多想法。我想說的是，我們非常致力於在我們的研究設計中變得極其高效和乾淨，並希望確保我們擁有盡可能直接且高效的程序路徑。

So as we looked to the data from this study, it is important know one of the things is particularly exciting about the drugs we're working on, and MM-120 in particular, is that the acute administration seems to drive a acute and durable response. And because of that, it does offer some advantages potentially in terms of the risk profile. So we wouldn't expect sort of physiological risk to persist like what if you're taking a daily medication.

因此，當我們查看這項研究的數據時，重要的是要知道我們正在研究的藥物（尤其是 MM-120）特別令人興奮的一件事是，急性給藥似乎會推動急性且持久的治療。回复。正因為如此，它確實在風險狀況方面提供了一些潛在的優勢。因此，我們預計不會出現像每天服用藥物那樣的生理風險。

So we'll certainly be monitoring outcomes, both efficacy and safety for the duration of the 12 weeks. We want to make sure that whatever dose we selected before in the Phase 3 is both responsive and in terms of efficacy, but also is well-tolerated, and we anticipate would be safe as we get into a larger part of the development program.

因此，我們肯定會在 12 週內監測結果，包括有效性和安全性。我們希望確保我們之前在第 3 階段選擇的任何劑量都具有反應性和功效，而且具有良好的耐受性，並且隨著我們進入開發計劃的更大部分，我們預計將是安全的。

With all that said, too, I think it's really important to note that based on the historical effect sizes, including effects as we've seen from investigator-initiated studies, while they're preliminary right in that part or up to a standard of support being evidence for an approval necessarily. Those effect sizes are quite large. And so we would anticipate that even if we were to choose a dose with -- better tolerated, let's say just theoretically or had a similar sort of response, we will be able to have a high degree of confidence. I think based on historical effects and if we're also been able to replicate that the sizing of the Phase 3 program would be adequate, it would give us plenty of patients to be able to demonstrate statistical difference if we see a clinically meaningful response as we anticipate.

話雖如此，我認為值得注意的是，根據歷史效應大小，包括我們從研究者發起的研究中看到的效應，雖然它們在該部分是初步正確的，或者達到了標準支持作為必要批准的證據。這些效應規模相當大。因此，我們預計，即使我們選擇的劑量具有更好的耐受性，比如說理論上或有類似的反應，我們也將能夠擁有高度的信心。我認為基於歷史效應，如果我們也能夠複製第 3 階段計劃的規模是足夠的，如果我們看到有臨床意義的反應，那麼我們將有大量患者能夠證明統計差異我們預計。

That's really helpful. Thanks, Rob. And then I guess secondarily, with regards to the 402 program. You mentioned the study that's going to be looking at racemic MDMA and the enantiomers in healthy volunteers in collaboration with the UHB, I was wondering if you could elaborate a little bit more on that study. What specifically you're going to be looking for in terms of the -- to better understand the pharmacology, the parameters you'll be exploring, and when we might report data there. And I'll hop back in the queue. Thanks.

這真的很有幫助。謝謝，羅布。其次，我想是關於 402 計劃的。您提到了一項與 UHB 合作研究健康志願者中的外消旋 MDMA 和對映體的研究，我想知道您是否可以詳細說明該研究。您具體要尋找什麼——為了更好地了解藥理學、您將探索的參數以及我們何時可能在那里報告數據。我會跳回到隊列中。謝謝。

Yeah. Thanks so much. So in terms of the study design, it's two different doses of R-MDMA. So 125 and 250 milligrams; a single dose of S-MDMA, and a single dose of racemic MDMA. And that is a in-patient -- all the patients would be crossover and receive these different treatments and 125 milligrams of S and racemic MDMA that's being administered here.

是的。非常感謝。因此，就研究設計而言，它是兩種不同劑量的 R-MDMA。所以125和250毫克；單劑量的 S-MDMA 和單劑量的外消旋 MDMA。這是一名住院患者，所有患者都會交叉接受這些不同的治療，並在這裡服用 125 毫克 S 和外消旋 MDMA。

So in terms of the outcomes that we're looking to -- largely, the pharmacodynamic outcomes. So overall drug effect in terms of intensity and duration. We are conducting is one of the primary outcome measures -- or I should say, Dr. Liechti's lab is connecting the five dimensions and altered states of consciousness, the 5D-ASC scale to also investigate the functional perception activity of between enantiomers and racemic MDMA.

因此，就我們所期待的結果而言，主要是藥效學結果。因此，總體藥物作用的強度和持續時間。我們正在進行的主要結果測量之一 - 或者我應該說，Liechti 博士的實驗室正在連接五個維度和改變的意識狀態，即 5D-ASC 量表，以研究對映體和外消旋 MDMA 之間的功能感知活動。

So we're looking at a number of autonomic effects, of mood effects. Of course, characterize the pharmacokinetics and looking at other endocrine effects, levels of oxytocin prolactin cortisol [in depression]. So many of the pathways have been implicated in the activity of our -- or racemic MDMA to characterize that response with two different doses. And ultimately, I think to inform how we advance our own Phase 1 program and it further into in the clinic and Phase 2 and beyond.

所以我們正在研究一些自主神經效應、情緒效應。當然，表徵藥代動力學並觀察其他內分泌效應、催產素催乳素皮質醇水平[抑鬱症]。許多途徑都與我們的或外消旋 MDMA 的活性有關，以表徵兩種不同劑量的反應。最後，我想告訴大家我們如何推進我們自己的第一階段計劃，並進一步進入臨床、第二階段及其他階段。

Got it. Thanks so much.

知道了。非常感謝。

Francois Brisebois, Oppenheimer.

弗朗索瓦·布里斯布瓦，奧本海默。

Hi. Thanks for taking the question. Congrats on the progress here. Just a couple here. In terms of the recent Hospital Basel study that you mentioned there, just so maybe if you could remind us the differences here. So multiple doses, the comparison is not to a true placebo and obviously a different indication, although similar comorbidities. And then so maybe just talk about the differences and how this could be a read-through towards your study. And any thoughts on patients keeping them on SSRIs versus winding them off and what they can do. Thank you.

你好。感謝您提出問題。恭喜這裡取得的進展。這裡只有一對夫婦。就您最近提到的巴塞爾醫院研究而言，也許您能提醒我們這裡的差異。因此，多次劑量，雖然有類似的合併症，但並不是與真正的安慰劑進行比較，而且顯然是不同的適應症。然後也許只是談談差異以及這如何成為你的研究的通讀。以及對患者繼續服用 SSRI 與停止服用 SSRI 的任何想法以及他們可以做什麼。謝謝。

Great. Thanks so much, Frank

偉大的。非常感謝，弗蘭克

. So in terms of the study design, this is an investigator-initiated study looking at the impact in patients with major depressive disorder. Patients in the active arm receive two different doses that were separated by month. First was 100-microgram dose. The second was a 200-microgram dose, which again was separated by four weeks. This control group in this study was administered a 25-microgram dose at both of the treatment days, so by the dosing session. So it was not an inert placebo, but we still did see a statistical and clinically meaningful differentiation between the response of those two doses. So we saw at 3.6-point improvement in the IDS-C score, which is the inventory of depression symptomatology score, six weeks after administration of the first that treat recession for the low-dose arm.

。因此，就研究設計而言，這是一項由研究者發起的研究，旨在研究對重度抑鬱症患者的影響。主動組的患者接受兩種不同的劑量，間隔一個月。第一個劑量是 100 微克。第二次劑量為 200 微克，兩次間隔四個星期。本研究中的對照組在兩個治療日均按給藥療程服用 25 微克劑量。因此，它不是惰性安慰劑，但我們仍然看到這兩種劑量的反應之間存在統計學和臨床意義的差異。因此，在低劑量組服用第一種治療衰退的藥物六週後，我們發現 IDS-C 評分（抑鬱症症狀學評分清單）提高了 3.6 分。

And we also saw a 12.9-point improvement on the IDS-C in the higher dose, 100 and the 200-microgram dose arm. Those effects remained durable out to 16 weeks. And we saw a number of encouraging secondary endpoints in the study.

我們還發現，在較高劑量、100 微克和 200 微克劑量組中，IDS-C 提高了 12.9 點。這些影響可持續長達 16 週。我們在研究中看到了許多令人鼓舞的次要終點。

So overall, we view it as particularly impactful and important given the relevance to depression, which is, of course, an area, an indication where there's a huge growth in incidence and prevalence and one where they had. We've also seen historical evidence of activity of the lysergide. But it's also particularly important to note that there's a high degree of comorbidity between generalizing anxiety I sort of major depressive disorder, both in terms of diagnostic overlap, which we think is incredibly high. But also the number of patients, the prevalence of diagnosis and the overlap in populations.

因此，總的來說，考慮到與抑鬱症的相關性，我們認為它特別有影響力和重要性，當然，抑鬱症是一個領域，表明發病率和患病率大幅增長，並且是一個明顯增長的領域。我們還看到了麥角酰活性的歷史證據。但還特別重要的是要注意，廣泛性焦慮症和重度抑鬱症之間存在高度的共病，無論是在診斷重疊方面，我們認為這種共病率都非常高。還有患者數量、診斷流行率和人群重疊。

We think it's both relevant to our GAD program, but also opens up an opportunity. We've seen historically strong, consistent responses in many studies and hundreds of patients with lysergide and anxiety and depression and other neuronic illness. And so this seems as consistent with the data we reported in the anxiety back in 2022, again, demonstrating a strong statistically significant response after acute administration -- what we hope to see in a depression study. And again, we think is critically important, both anxiety and opens up the door to potentially having other indications in the future.

我們認為這既與我們的 GAD 計劃相關，又帶來了機會。我們在許多研究和數以百計的患有麥角酰亞胺、焦慮症、抑鬱症和其他神經系統疾病的患者中看到了歷史上強烈、一致的反應。因此，這似乎與我們在 2022 年報告的焦慮症數據一致，再次證明了急性給藥後具有統計學上顯著的強烈反應——我們希望在抑鬱症研究中看到這一點。再說一次，我們認為這一點至關重要，既焦慮又為未來可能出現其他跡像打開了大門。

Okay, great. And can you remind me if were the patients on no SSRIs or whatever they were on or were they dosed in this trial?

好的，太好了。您能否提醒我，在本次試驗中，患者是否未服用 SSRI 藥物或其他藥物，或者是否服用了藥物？

Some additional details about the specifics there will be forthcoming as soon as the full publication is released. But generally, to comment broadly about your question, we don't have the modern data to fully characterize the difference in either pharmacokinetics or pharmacodynamics. I think we have particularly more interest with concurrent administration of SSRIs and a molecule-like MM-120.

完整出版物發布後，將立即公佈有關具體細節的一些其他詳細信息。但一般來說，要廣泛地評論您的問題，我們沒有現代數據來充分描述藥代動力學或藥效學的差異。我認為我們對 SSRIs 和分子樣 MM-120 的同時給藥特別感興趣。

But historical data has suggested that there may be an alteration to PD profile, but we haven't seen any evidence that that would be alarming or safety signal. So something we are certainly monitoring, and no others and academic researchers have been interested in that differentiation of response. And certainly as we progress and developments, we're going to be looking at very closely.

但歷史數據表明 PD 概況可能會發生變化，但我們還沒有看到任何證據表明這會是令人震驚或安全的信號。所以我們肯定正在監測一些事情，沒有其他人和學術研究人員對這種反應的差異感興趣。當然，隨著我們的進步和發展，我們將非常密切地關注。

Okay, great. And then in terms of the R&D Day that you mentioned with Sobi in the second quarter. Is that where you plan on sharing more details about your commercialization plans for each product or is that kind of at a later time?

好的，太好了。然後就您在第二季度與 Sobi 提到的研發日而言。您是否打算在其中分享有關每種產品商業化計劃的更多詳細信息，或者是稍後再分享？

I think as we think about R&D day in second quarter, one of the key things we would like to highlight is an update on the progress of the clinical trial of our overall programmatic approach or speak much more to the intellectual property and market protection strategy. And they got some important insights that should make -- make it a very clear story to anyone who's been looking at market protection and the ability to protect a novel asset.

我認為，當我們考慮第二季度的研發日時，我們要強調的關鍵事情之一是我們整體計劃方法的臨床試驗進展的最新情況，或者更多地談論知識產權和市場保護策略。他們得到了一些重要的見解，對於任何一直在關注市場保護和保護新資產的能力的人來說，這些都是一個非常清晰的故事。

So that would be one area of focus whilst obviously dig into and have some key opinion leaders talking about generalized anxiety disorder as an indication and where treatment might fit in overall landscape. And there, we'll also have an opportunity to present some individuals who have actively done clinical trials and research with LSD -- with the drug class generally and provide some insight into the commercial viability in that way.

因此，這將是一個重點領域，同時顯然會深入研究並讓一些關鍵意見領袖談論廣泛性焦慮症作為一種適應症以及治療可能適合整體情況的情況。在那裡，我們還將有機會介紹一些積極進行 LSD 臨床試驗和研究的個人 - 總體上介紹藥物類別，並以這種方式提供對商業可行性的一些見解。

I think certainly as we progress and reach Phase 2 readout and getting to and into Phase 2 program and total clarity on what the path to our late-stage program looks like, we'll be in a position at that point to speak a little bit more about market access and the overall commercialization strategy. But certainly our Investor Day coming up in the second quarter. We'll be giving a lot more insight into the status of the programs and I think greater clarity on the elements of our -- all the product that we are trying to take to market and our overall approach there.

我認為，當然，隨著我們取得進展並達到第二階段的結果，進入第二階段計劃，並完全清楚通往後期計劃的道路是什麼樣子，我們將能夠在這一點上說一點有關市場准入和整體商業化戰略的更多信息。但我們的投資者日肯定會在第二季度舉行。我們將更深入地了解這些計劃的狀態，我認為我們將更清楚地了解我們試圖推向市場的所有產品以及我們在那裡的總體方法。

Okay, great. Thank you very much.

好的，太好了。非常感謝。

Elemer Piros, EF Hutton.

埃萊默·皮羅斯，EF 赫頓。

Yes, good afternoon. What I'd like to verify, Rob, is the 20 clinical sites that you previously identified. Is this the final number for the GAD trial?

是的，下午好。 Rob，我想核實的是您之前確定的 20 個臨床站點。這是 GAD 試驗的最終數字嗎？

So the 20 clinical sites was certainly in our study, assuming the number of sites that as we note earlier in the year, were brought online and we're fully recruiting beginning of the year. And we've seen a lot of interest from a number of sites in a number of highly experienced sites. And as we think about site engagement and bringing sites online, they can both be driven by -- an individual study is also programmatically, right. So we have an opportunity to engage with sites that might be great sites in a later-stage Phase 3 program.

因此，這 20 個臨床中心肯定在我們的研究範圍內，假設我們今年早些時候注意到的臨床中心數量已上線，並且我們將在今年年初全面招募。我們已經看到許多經驗豐富的網站對我們表現出了濃厚的興趣。當我們考慮網站參與度和網站上線時，它們都可以由單獨的研究驅動，也是有計劃的，對吧。因此，我們有機會與可能在第三階段項目後期的優秀網站進行合作。

So we're actively engaged with a number of discussions and a number of different avenues to make sure we can be as efficient as possible getting into that pivotal program. But certainly, 20 sites as we've started and currently actually enrolling patients.

因此，我們積極參與了許多討論和許多不同的途徑，以確保我們能夠盡可能高效地參與該關鍵計劃。但可以肯定的是，我們已經啟動了 20 個站點，目前正在實際招募患者。

Yeah. And at the end of the year, would we -- shall we expect primary endpoint information? So efficacy at four weeks or maybe some latter time points, eight weeks and 12 weeks as you have dosed a secondary endpoint.

是的。到今年年底，我們是否會期待主要終點信息？因此，在 4 週或稍後的某個時間點、8 周和 12 週時的療效，因為您已經服用了次要終點。

We certainly anticipate reading out at least topline readout. The four-week data was the primary endpoint of the study. So we're going to have greater clarity as we progress and give an update on the study in the future. But our expectation when we speak to topline results will be at least reading out the primary endpoint.

我們當然預計至少會讀出頂線讀數。四周的數據是該研究的主要終點。因此，隨著我們的進展，我們將更加清晰，並在未來提供研究的更新。但當我們談到主要結果時，我們的期望至少是讀出主要終點。

Yeah. And I just found this company called MindBio who is doing a -- or plan to do a micro dosing LSD trialed in MDD. Do you think that they would have freedom to operate if they continue to pursue that indication?

是的。我剛剛發現這家名為 MindBio 的公司正在做或計劃做一種在 MDD 中試驗的微劑量 LSD。您認為如果他們繼續追求這一指示，他們會有操作自由嗎？

Well, again, in terms of intellectual property, certainly in a research setting, there's a carve-out for doing research. So anything of that nature wouldn't come into play until much later down the road. But where we are positioned in the program and the kind of support we've had, the team we've built, the efficiency we'll have demonstrated as we get the readout by the end of this year, I think will make it very clear where everyone stands in the market who is likely to be first in market with any sort of LSD products.

好吧，再說一遍，就知識產權而言，當然在研究環境中，進行研究是有一定限制的。因此，這種性質的任何事情直到很久以後才會發揮作用。但是，我們在該計劃中的定位以及我們所獲得的支持類型、我們建立的團隊以及我們在今年年底之前獲得讀數時所展示的效率，我認為這將使其變得非常重要清楚每個人在市場上的地位，誰可能是任何類型的 LSD 產品的第一個市場人。

And just last two small questions here. Do you have a cutoff value for the Ham 8 score at baseline in the GAD trial or a minimum severity.

最後兩個小問題。您是否有 GAD 試驗基線時 Ham 8 評分的截止值或最低嚴重程度？

I'll just turn it over to Dan Karlin again.

我會再次將其交給 Dan Karlin。

I don't believe that we've publicly disclosed that minimum cutoff score at the current time just to maintain trial integrity. So yes, we do have a score in general, just for integrity purposes. I don't believe this is publicly disclosed.

我不認為我們目前公開披露最低分數線只是為了保持試驗的完整性。所以，是的，我們確實有一個總體評分，只是出於完整性目的。我不相信這是公開披露的。

I'll just I'll expand on that real quickly. We have -- if we pointed to our investor presentations published on our website, the minimum score we require to be enrolled in the trial as an entry criterion is the Hamilton Anxiety Score of 20 or greater.

我會很快擴展這一點。如果我們指出我們網站上發布的投資者演示文稿，我們要求參加試驗作為進入標準的最低分數是漢密爾頓焦慮分數 20 或更高。

20 or greater. Okay. Thanks for clarifying that. And do you expect a good portion of the patients do have depression as a comorbidity in this study?

20 或更多。好的。感謝您澄清這一點。您認為這項研究中很大一部分患者確實患有抑鬱症嗎？

But based on the overall population, the comorbidity of GAD and major depression disorder, we certainly anticipate that the patients would have comorbid diagnosis with depression. What's critically important is to have a GAD as the primary diagnosis, but it would not be a representative population. If you had an indication such as GAD, there wasn't some comorbid depression in the study.

但根據總體人群、廣泛性焦慮症和重度抑鬱症的合併症，我們當然預計患者會患有抑鬱症的合併症。至關重要的是以廣泛性焦慮症作為主要診斷，但它不會是一個具有代表性的人群。如果您有廣泛性焦慮症等跡象，則研究中不存在任何共病抑鬱症。

But you are not examining efficacy based on a reduction in depressive symptoms. You've --

但您並不是根據抑鬱症狀的減輕來檢驗療效。你已經——

Obviously, we absolutely are as secondary outcome measures. We're absolutely looking at response on standard depression scales and would reduce -- another important insight into potential response in depression.

顯然，我們絕對是作為次要結果衡量標準。我們絕對會關注標準抑鬱量表的反應，並會減少——這是對抑鬱症潛在反應的另一個重要見解。

Yeah, wonderful. Thank you very much for both of you.

是的，太棒了。非常感謝你們倆。

Patrick Trucchio, H.C. Wainwright.

帕特里克·特魯基奧 (Patrick Trucchio)，H.C.溫賴特。

Thanks. Good evening. Just I'm wondering if you look at the broader of space of sponsors exploring psychoactive agents, how do you view the differentiation of MM-120 relative to some of the shorter acting compounds like psilocybin or 5-MeO-DMT? Do you see the advantages primarily on the efficacy and potential duration of remission or is there also potential separate on seeking tolerability profile as well?

謝謝。晚上好。我只是想知道，如果您關注探索精神活性藥物的申辦者的更廣闊空間，您如何看待 MM-120 相對於一些作用較短的化合物（如裸蓋菇素或 5-MeO-DMT）的差異？您是否認為主要在療效和潛在緩解持續時間方面具有優勢，或者在尋求耐受性方面也存在潛在的單獨優勢？

Yeah, thanks for the question, Patrick.

是的，謝謝你的提問，帕特里克。

So when we look at the history of research on this drug class, as a drug developer, you want to see drugs that have a likelihood of demonstrating that this -- or have benefit risk profile that ultimately gets you to an application and an approval. And LSD is the most characterized drug in the entire class. And there's certainly been a lot of discussion about shorter-acting molecules.

因此，當我們回顧此類藥物的研究歷史時，作為藥物開發商，您希望看到有可能證明這一點的藥物，或者俱有最終使您獲得申請和批准的益處風險特徵的藥物。 LSD 是整個類別中最具特色的藥物。關於短效分子當然有很多討論。

What we know from the real world, I think it's important to highlight, there's a fairly large, expanded access or compassionate use program that's ongoing in Switzerland. In our collaboration both for Dr. Liechti at UHB and more broadly with many psychiatrists in Switzerland has given us some real insights. These providers are able to utilize psilocybin or LSD. And in many instances when we have discussions about the preference, they choose to use LSD.

我認為有必要強調一下，我們從現實世界中了解到的情況是，瑞士正在進行一項相當大的、擴大的訪問或同情使用計劃。在我們與 UHB Liechti 博士以及更廣泛的瑞士許多精神科醫生的合作中，我們獲得了一些真正的見解。這些提供者能夠使用裸蓋菇素或 LSD。在很多情況下，當我們討論偏好時，他們會選擇使用LSD。

They also have indicated on multiple occasions that the actual conduct of administration sessions, whether it's LSD or psilocybin occurs for approximately the same duration. And that's going to obviously vary by the individual. But we thought it was a particularly important insight that that in practice in the real world where this is being done regularly and has been done for several years, there isn't a significant differentiation between those two molecules.

他們還多次表示，無論是LSD還是裸蓋菇素，實際給藥過程的持續時間大致相同。這顯然會因個人而異。但我們認為這是一個特別重要的見解，在現實世界中，這種情況定期進行並且已經進行了好幾年，這兩種分子之間沒有顯著差異。

Some of the ultra-shorter-acting molecules such as DMT or 5-MeO-DMT, these are certainly molecules that work on serotonin system. But what we need to characterize is the both the acute and durable response. And that's what we certainly see more from historical data of LSD and gives us an extraordinary degree of excitement around the potentials of our product candidates.

一些超短效分子，如 DMT 或 5-MeO-DMT，這些肯定是作用於血清素系統的分子。但我們需要描述的是這種反應既迅速又持久。這當然是我們從 LSD 的歷史數據中看到的更多內容，並讓我們對候選產品的潛力感到非常興奮。

Can you talk more about the health economic outcome research that you referred to earlier and understanding that there's still more planning here to be done. I'm wondering what would this potentially look like prior to the launch and how big of a differentiator would it be for MM-120 if you have this type of data at the time of or soon after a potential launch?

您能否更多地談談您之前提到的健康經濟成果研究，並了解這裡還有更多的計劃需要完成。我想知道在發布之前這可能會是什麼樣子，如果您在潛在發佈時或發布後不久擁有此類數據，那麼 MM-120 的差異化程度有多大？

Yes, right. I wouldn't want to speak too much of the specifics at this point, but we are actively engaged both with Francois Lilienthal, our Chief Commercial Officer, who has an incredible career in commercial launches, including most recently at Merck before coming over to MindMed to demonstrate the value proposition and make sure we have a path for commercialization for market access to reimbursement. And also our digital medicine programs, which gives us an extraordinary opportunity to gather such data and engage in longer-term observational studies both of patients with disorders we are seeking to treat.

是的，沒錯。我現在不想談論太多細節，但我們正在積極與我們的首席商務官 Francois Lilienthal 接觸，他在商業發布方面擁有令人難以置信的職業生涯，包括最近在默克 (Merck) 工作，然後來到 MindMed展示價值主張，並確保我們有一條商業化的道路，以獲取報銷的市場准入。還有我們的數字醫學項目，它為我們提供了一個絕佳的機會來收集此類數據，並對我們正在尋求治療的疾病患者進行長期觀察研究。

But also more specifically in terms of any particular risk areas of research interest to us, both internally and through some of our collaborations. So certainly be sharing more as we progress and as we get to have more clarity or share more clarity, I should say, on the commercialization pathway and alternate plans. We'll give additional insights in terms of our approach to [HER] data generation and also the implications for market access pricing reimbursement such.

但更具體地說，是我們內部和通過我們的一些合作研究感興趣的任何特定風險領域。因此，隨著我們的進步，隨著我們變得更加清晰或分享更多的清晰度，我應該說，在商業化途徑和替代計劃上，當然會分享更多。我們將就我們的 [HER] 數據生成方法以及對市場准入定價報銷的影響提供更多見解。

That's helpful. Just one last one for me. Can you talk about just broader strategic priorities as it relates to business development? And specifically, how do you think about potential partnership activities following the Phase 2 readouts for MM-120 later this year?

這很有幫助。給我的只是最後一張。您能否談談與業務發展相關的更廣泛的戰略優先事項？具體來說，您如何看待今年晚些時候 MM-120 第二階段結果公佈後的潛在合作活動？

Yes, we've certainly seen quite a bit of interest in our program and our readout. And anytime where we have advanced to the point where -- reach the disclosure special, we will certainly do so. But at this point, we haven't -- we do not have any business development or licensing or partnership agreements for subsequent development program. But again, we've seen high degree of engagement and excitement both in terms of the serotonin system as a target, which is one of the best characterize systems in all psychiatry; but also in particular in our program and in our approach, the ability to generate the kind of robust data and the consistency with which we're approaching our clinical development program.

是的，我們確實看到人們對我們的程序和讀數相當感興趣。任何時候，只要我們已經進步到了特別披露的地步，我們一定會這樣做。但目前，我們還沒有 - 我們沒有任何後續開發計劃的業務開發或許可或合作協議。但我們再次看到以血清素系統為目標的高度參與和興奮，這是所有精神病學中最好的特徵系統之一；但特別是在我們的計劃和我們的方法中，生成可靠數據的能力以及我們接近臨床開發計劃的一致性。

Our Phase 2 study design and the way we've operationalized this study is exactly how we anticipate progressing into the Phase 3 program. And we think that gives us a great opportunity to transition out without changing any of the variables that are important in terms of conduct of the study and mostly could impact safety or effectiveness. So certainly seen a lot of excitement across the Board, and we'll keep any of our options open as we progress.

我們的第二階段研究設計以及我們實施這項研究的方式正是我們預期進入第三階段計劃的方式。我們認為，這為我們提供了一個很好的機會，可以在不改變任何對研究進行很重要且主要可能影響安全性或有效性的變量的情況下進行過渡。因此，我們肯定看到了整個董事會的很多興奮，隨著我們的進展，我們將保留任何選擇。

That's helpful. Thank you very much.

這很有幫助。非常感謝。

(Operator Instructions) There are no further questions at this time. I will now turn it back for closing remarks.

（操作員說明） 目前沒有其他問題。我現在將其轉回以供結束語。

Thank you, operator, and thanks, everyone, again for joining us today. We're extremely pleased with where we've come so far this year and are incredibly encouraged by moving very quickly to a data readout in late 2023 for our lead program and getting our sailing program, the MM-402 in the clinic later this year.

再次感謝您，接線員，也感謝大家今天加入我們。我們對今年迄今為止所取得的進展感到非常滿意，並且我們非常鼓舞地在 2023 年底為我們的主導項目進行數據讀出，並在今年晚些時候將我們的帆船項目 MM-402 投入臨床。

Thanks, everyone again for joining us. And I look forward to sharing future updates.

再次感謝大家加入我們。我期待分享未來的更新。

Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

謝謝。女士們、先生們，今天的電話會議到此結束。我們感謝您的參與，並請您斷開線路。