Brainstorm Cell Therapeutics Inc (BCLI) 2023 Q2 法說會逐字稿

Greetings, and welcome to the Brainstorm Cell Therapeutics second-quarter 2023 earnings call. (Operator Instructions) As a reminder, this call is being recorded.

您好，歡迎參加 Brainstorm Cell Therapeutics 2023 年第二季財報電話會議。 （操作員說明）謹此提醒，此通話正在錄音。

And I would now like to introduce your host for today's call, Mr. Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

現在我想介紹今天的電話會議主持人，LifeSci Advisors 的 Michael Wood 先生。伍德先生，您可以開始了。

Good morning, and thank you for joining us this morning. Earlier today, Brainstorm issued a press release with its financial results for the second quarter of 2023, including a corporate update.

早安，感謝您今天早上加入我們。今天早些時候，Brainstorm 發布了一份新聞稿，公佈了 2023 年第二季的財務業績，其中包括公司最新情況。

Before passing it off the company for prepared remarks, I'd like to remind listeners that this conference call will contain numerous statements, descriptions, forecasts, and projections regarding Brainstorm Cell Therapeutics and its potential future business operations and performance statements regarding the market potential for the treatment of neurodegenerative diseases such as ALS, the sufficiency of the company's existing capital resources for continued operations in 2023 and beyond, the safety and clinical effectiveness of NurOwn technology platform, clinical trials of NurOwn and related clinical development programs, and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts.

在將其交給公司準備好的發言之前，我想提醒聽眾，本次電話會議將包含有關 Brainstorm Cell Therapeutics 及其未來潛在業務運營的大量聲明、描述、預測和預測，以及有關市場潛力的業績聲明ALS等神經退化性疾病的治療、公司現有資本資源是否足以維持2023年及以後的持續運作、NurOwn技術平台的安全性和臨床有效性、NurOwn的臨床試驗及相關臨床開發項目以及公司的能力發展策略合作和夥伴關係以支持其業務規劃工作。

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Brainstorm's control, including the risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected on today's call, and the company undertakes no obligation to publicly update any forward-looking statements.

前瞻性陳述受到眾多風險和不確定性的影響，其中許多風險和不確定性超出了 Brainstorm 的控制範圍，包括該公司在 SEC 備案文件中不時描述的風險和不確定性。該公司的業績可能與今天電話會議中預測的結果有重大差異，該公司不承擔公開更新任何前瞻性聲明的義務。

Joining us on the call this morning will be Chaim Lebovits, President and CEO of Brainstorm; Dr. Stacy Lindborg, Co-Chief Executive Officer; and Alla Patlis, Interim Chief Financial Officer. In addition, Brainstorm's Executive VP and Chief Medical Officer, Dr. Kirk Taylor, is also on the call and will be available to answer questions during the Q&A session. So I'd like to turn the call now to Mr. Lebovits. Please go ahead.

今天早上參加我們電話會議的還有 Brainstorm 總裁兼執行長 Chaim Lebovits； Stacy Lindborg 博士，聯合執行長；臨時財務長 Alla Patlis。此外，Brainstorm 的執行副總裁兼首席醫療官 Kirk Taylor 博士也參加了電話會議，並將在問答環節回答問題。我現在想把電話轉給萊博維茨先生。請繼續。

Thank you, Michael. Thank you all who have joined us to discuss our Q2 2023 financial results and recent progress. Our main priorities right now are to prepare for the forthcoming advisory committee for NurOwn, our investigational therapy for the treatment of ALS, and to make sure the company is prepared to make NurOwn available to patients.

謝謝你，邁克爾。感謝大家與我們一起討論我們 2023 年第二季的財務表現和最新進展。我們目前的主要優先事項是為即將成立的 NurOwn 諮詢委員會做好準備，NurOwn 是我們治療 ALS 的研究療法，並確保公司準備好向患者提供 NurOwn。

As announced in June, the FDA will convene a meeting of the cellular tissue and gene therapies advisory committee to review our BLA for NurOwn on September 27. In addition, the BLA has been assigned a PDUFA action date of December 8, 2023.

正如 6 月宣布的那樣，FDA 將於 9 月 27 日召開細胞組織和基因治療諮詢委員會會議，審查我們針對 NurOwn 的 BLA。此外，BLA 已指定 PDUFA 行動日期為 2023 年 12 月 8 日。

NurOwn's regulatory process, as we have mentioned previously, will be the same as it is for any other investigational therapy that is subject of a filed BLA. The upcoming outcome will be guided by an agenda that includes detailed presentations, a brainstorm, and the FDA, which will allow our team and the agency to discuss the clinical evidence supporting NurOwn's safety and efficacy as an ALS therapy.

正如我們之前提到的，NurOwn 的監管流程將與任何其他已提交 BLA 的研究療法相同。即將到來的結果將以包括詳細演示、頭腦風暴和 FDA 的議程為指導，這將使我們的團隊和該機構能夠討論支持 NurOwn 作為 ALS 療法的安全性和有效性的臨床證據。

Other key stakeholders, including independent medical experts, statisticians, and patient advocates, will then have the opportunity to provide their own unique perspective on NurOwn's clinical dataset as well as the unmet needs of people living with ALS. Members of the AdCom will then have the opportunity to vote on the response to the question set forth by the FDA.

其他主要利害關係人，包括獨立醫學專家、統計學家和患者權益倡導者，將有機會就 NurOwn 的臨床數據集以及 ALS 患者未滿足的需求提供自己獨特的視角。然後，AdCom 成員將有機會就 FDA 提出的問題的答覆進行投票。

The agency will take the results of this vote or these votes, as well as the preceding discussions at the meeting under advisement when coming to a decision on the BLA, which will be made by the December 8 PDUFA date.

該機構將在就 BLA 做出決定時考慮本次投票的結果以及先前會議上的討論，該決定將於 12 月 8 日 PDUFA 日期之前做出。

Given the strength of the clinical evidence we have generated at NurOwn, we remain confident in our ability to achieve a successful outcome from the AdCom and are preparing for success to ensure we can make NurOwn available to patients as quickly as possible if approved later this year.

鑑於我們在 NurOwn 產生的臨床證據的強度，我們對 AdCom 取得成功結果的能力仍然充滿信心，並正在為成功做好準備，以確保如果今年晚些時候獲得批准，我們可以盡快將 NurOwn 提供給患者。

Our team is focused on being fully prepared in advance of the upcoming AdCom. These preparations began months ago and continue today as we work with our expert consultants to ensure we can present and respond to all questions that the FDA and AdCom members might raise.

我們的團隊致力於為即將到來的 AdCom 做好充分準備。這些準備工作從幾個月前開始，一直持續到今天，我們與專家顧問合作，確保我們能夠提出並回答 FDA 和 AdCom 成員可能提出的所有問題。

We are grateful to the FDA for its cooperation throughout the review process and recognize that the agency is taking our application very seriously.

我們感謝 FDA 在整個審查過程中的合作，並認識到該機構非常認真地對待我們的申請。

I'll now turn the call over to my colleague, Dr. Stacy Lindborg, for additional comments, Stacy?

我現在將把電話轉給我的同事 Stacy Lindborg 博士，徵求更多意見，Stacy？

Thank you, Chaim. We are looking forward to the AdCom in September and cannot overstate the importance of this meeting in NurOwn's regulatory path given the scientific and policy issues that need to be understood.

謝謝你，查姆。我們期待 9 月召開的 AdCom，鑑於需要了解的科學和政策問題，怎麼強調這次會議在 NurOwn 監管道路上的重要性都不為過。

The FDA has rightly shown a willingness to apply regulatory flexibility when evaluating investigational ALS therapies over the last year, and we look forward to having NurOwn's full data set discussed in the context of the need for new ALS therapies in the public forum offered by an AdCom.

去年，FDA 在評估研究性 ALS 療法時正確地表現出了應用監管靈活性的意願，我們期待在 AdCom 提供的公共論壇上在對新 ALS 療法的需求的背景下討論 NurOwn 的完整數據集。

As we move towards the FDA's decision, we continue to have full confidence in our data and believe that a comprehensive analysis of our results strongly support NurOwn's clinical efficacy and safety. We remain committed to the scientific and regulatory process, which includes continuing research to confirm the results of the NurOwn clinical program.

當我們朝著 FDA 的決定邁進時，我們繼續對我們的數據充滿信心，並相信對我們結果的全面分析有力地支持了 NurOwn 的臨床療效和安全性。我們仍然致力於科學和監管流程，其中包括繼續研究以確認 NurOwn 臨床計劃的結果。

We also remain committed to ongoing learning about the safety and the clinical effectiveness of NurOwn. For this reason, we have assembled a steering committee to gather input on goals and the core design elements of a confirmatory trial. We look forward to providing an update prior to the AdCom.

我們也持續致力於不斷了解 NurOwn 的安全性和臨床有效性。因此，我們組成了一個指導委員會，收集有關驗證性試驗的目標和核心設計要素的意見。我們期待在 AdCom 召開之前提供最新情況。

We continue to be active with the ALS community at scientific conferences. We delivered an important presentation featuring new biomarker data and at the recent 2023 Gordon Research Conference for ALS and related motor neuron diseases.

我們繼續在科學會議上積極參與 ALS 社區的活動。我們在最近舉行的 2023 年戈登 ALS 及相關運動神經元疾病研究會議上發表了重要演講，介紹了新的生物標記數據。

As we described previously, during the NurOwn Phase 3 trial, we collected CSF fluid from all trial participants and examined biomarkers spanning three pathways important to ALS pathology: neuroinflammation, neurodegeneration, and neuroprotection.

正如我們之前所描述的，在 NurOwn 3 期試驗期間，我們收集了所有試驗參與者的腦脊髓液，並檢查了對 ALS 病理學重要的三個途徑的生物標記：神經發炎、神經變性和神經保護。

The study is the most robust CSF biomarker study conducted in people living with ALS. And the new data presented at the Gordon Conference features analysis of a biomarker known as neurofilament light in addition to more broadly providing evidence of the importance of using baseline disease characteristics in the analysis of biomarker data, which I'll provide the rationale for.

該研究是針對 ALS 患者進行的最穩健的腦脊髓液生物標記研究。戈登會議上提出的新數據除了更廣泛地提供證據證明在生物標記數據分析中使用基線疾病特徵的重要性之外，還對一種稱為神經絲光的生物標誌物進行了分析，我將提供其基本原理。

I believe we all appreciate how heterogeneous ALS is as a disease. Because of this, it is common practice to include ALS disease characteristics of [covariates] in the analysis of clinical data, which we also did our Phase 3 trial. The goal is to include information that could influence an individual's prognosis in addition to therapy so that you're drawing appropriate conclusions relative to the treatment effects in the trials.

我相信我們都明白 ALS 作為一種疾病的異質性。因此，在臨床數據分析中納入[協變量]的 ALS 疾病特徵是常見的做法，我們也進行了 3 期試驗。目標是除了治療之外還包括可能影響個體預後的訊息，以便您就試驗中的治療效果得出適當的結論。

When we decided to include these as covariates in our biomarker analyses, we drew on the ALS literature and the final guidance released in 2023 by the FDA on adjusting for covariates in randomized clinical trials for drugs and biologic products.

當我們決定將這些作為協變量納入我們的生物標記分析時，我們參考了 ALS 文獻以及 FDA 於 2023 年發布的關於調整藥物和生物製品隨機臨床試驗中協變量的最終指南。

What's the goal of exploring the importance of ALS disease characteristics in our biomarker data? From Phase 3, we employed five disease covariates that were prespecified and used in a primary efficacy model in the trial. These covariates, which include baseline ALSFRS-R score, the baseline rate of decline, use of riluzole, fight of ALS disease onset, and time since symptom onset to treatments, are well supported in the literature.

探索 ALS 疾病特徵在我們的生物標記數據中的重要性的目標是什麼？從第 3 階段開始，我們採用了預先指定的五種疾病協變量，並在試驗的主要療效模型中使用。這些協變量，包括基線 ALSFRS-R 評分、基線下降率、利魯唑的使用、ALS 疾病發作的抵抗以及從症狀發作到治療的時間，在文獻中得到了充分支持。

As highlighted in our poster presentation, all five disease covariates, in addition to biomarker data, had a significant impact on clinical outcomes. Therefore, the analysis of biomarker data can reflect the treatment effect more accurately when accounting for the baseline heterogeneity of participants. Including these covariates in the analysis across all biomarkers simply adds precision to the results.

正如我們的海報演示中所強調的，除了生物標記數據之外，所有五種疾病協變量都對臨床結果產生重大影響。因此，生物標記數據分析在考慮參與者基線異質性的情況下可以更準確地反映治療效果。在所有生物標記的分析中包含這些協變量只會增加結果的精確度。

In the poster, we highlighted the longitudinal trajectory of four biomarkers, including neurofilament light as examples of the improvements observed in biomarkers following treatment with NurOwn compared to placebo across all participants in the trial.

在海報中，我們強調了四種生物標記的縱向軌跡，其中包括神經絲光，作為試驗中所有參與者與安慰劑相比，使用 NurOwn 治療後觀察到的生物標記改善的例子。

Neurofilament light has been getting a lot of attention in the scientific community and with drug developers as evidenced by the exponential growth in publications in recent years. In NurOwn-treated participants, we observed an 11% decrease from baseline to week 20 in neurofilament light, with the change of around 1% with placebo and a significant treatment difference of a P less than 0.05.

神經絲光已受到科學界和藥物開發商的廣泛關注，近年來出版物的指數增長證明了這一點。在接受 NurOwn 治療的參與者中，我們觀察到第 20 週時神經絲光較基線下降了 11%，安慰劑組的變化約為 1%，顯著的治療差異 P 小於 0.05。

The other biomarkers highlighted in the poster also showed significant treatment differences with the decreases in pro-inflammatory biomarker MCP-1 and large increases in neuroprotective biomarkers, VEGF and Galectin-1.

海報中突出顯示的其他生物標記也顯示出顯著的治療差異，促炎生物標記 MCP-1 減少，神經保護生物標記 VEGF 和 Galectin-1 大幅增加。

I also presented two other results in the poster. First, neurofilament light baseline levels appear to be prognostic of ALS disease progression. This means that participants with higher baseline neurofilament light values had greater decline from baseline to week 28 as measured by the ALSFRS-R. This finding confirms the results seen in other ALS trials, which is promising for the field.

我還在海報中展示了另外兩個結果。首先，神經絲光基線水平似乎可以預測 ALS 疾病進展。這意味著根據 ALSFRS-R 測量，基線神經絲光值較高的參與者從基線到第 28 週的下降幅度更大。這項發現證實了其他 ALS 試驗的結果，這對該領域來說是有希望的。

The last analysis we presented was motivated by the literature and has been used in the review and approval products by the FDA in diseases such as pulmonary arterial hypertension and triple-class refractory multiple myeloma in addition to ALS through the review of tofersen.

我們提出的最後一項分析是受文獻啟發，透過對 tofersen 的審查，已用於 FDA 審查和批准的產品，用於 ALS 以外的肺動脈高壓和三級難治性多發性骨髓瘤等疾病。

And while NurOwn's mechanism of action is very different from tofersen, as we have a broad multi-modal mechanism faction simultaneously targeting biological deficiencies associated with ALS, we felt these analyses were important to conduct and understand the insights derived into our data based on the relationship between neurofilament light and clinical outcome.

雖然NurOwn 的作用機制與tofersen 有很大不同，但由於我們有一個廣泛的多模式機制派系，同時針對與ALS 相關的生物缺陷，我們認為這些分析對於進行和理解基於關係的數據得出的見解非常重要神經絲光和臨床結果之間的關係。

The analysis used an approach called causal inference, sometimes referred to as outcomes regression, and it allows us to explore the relationship between the change in neurofilament light and the change in ALSFRS-R due to NurOwn alone by adjusting the observed outcome with the change we would have expected due to the natural progression of the disease.

該分析使用了一種稱為因果推理的方法，有時稱為結果回歸，它使我們能夠透過根據我們的變化調整觀察到的結果，探索神經絲光的變化與僅由NurOwn 引起的ALSFRS-R 變化之間的關係。由於疾病的自然進展，這是可以預期的。

The analysis presented confirm that NurOwn-driven reductions in neurofilament light are associated with less decline in the ALSFRS-R from baseline to week 28. Taken together, data from the literature and the NurOwn Phase 3 trials, support the hypothesis that treatment-driven reduction in neurofilament light are reasonably likely to be associated with clinical benefit in ALS.

分析結果證實，NurOwn 驅動的神經絲光減少與 ALSFRS-R 從基線到第 28 週的下降幅度較小相關。總而言之，來自文獻和 NurOwn 3 期試驗的數據支持以下假設：治療驅動的神經絲光減少神經絲光中的光很可能與ALS 的臨床效益有關。

We believe these results are timely given the regulatory precedent that was set in ALS this year. In April, the FDA granted accelerated approval to Biogen and Ionis's drug, tofersen, to treat a genetic form of ALS known as SOD1 ALS, which represents approximately 2% of ALS patients.

鑑於今年 ALS 開創的監管先例，我們認為這些結果是及時的。今年 4 月，FDA 加速批准 Biogen 和 Ionis 的藥物 tofersen，用於治療一種稱為 SOD1 ALS 的基因型 ALS，這種疾病約佔 ALS 患者的 2%。

The approval decision was based in part on tofersen's ability to lower plasma levels of neurofilament light, establishing the view that reductions in neurofilament light are reasonably likely to be associated with clinical benefit in ALS.

批准決定部分基於 tofersen 降低血漿神經絲光水平的能力，建立了這樣的觀點：神經絲光的減少很可能與 ALS 的臨床益處有關。

Specifically, when the AdCom that reviewed tofersen was asked whether the available evidence supported a reduction in plasma neurofilament concentration as reasonably likely to predict clinical benefit, the committee voted unanimously nine to zero. This is the first time an ALS drug was approved by the FDA based on biomarker data.

具體來說，當審查托弗森的 AdCom 被問及現有證據是否支持血漿神經絲濃度的降低可以合理地預測臨床益處時，委員會以 9 比 0 一致投票。這是 FDA 首次根據生物標記數據批准 ALS 藥物。

I'll now turn the call back to Chaim for some additional comments.

現在，我將把電話轉回 Chaim，徵求一些補充意見。

Thank you, Stacy. Our second main priority, as I mentioned earlier, is to ensure commercial preparedness and execute on the various activities that we need to complete in order to make NurOwn available to patients if approved.

謝謝你，史黛西。正如我之前提到的，我們的第二個主要優先事項是確保商業準備並執行我們需要完成的各種活動，以便在獲得批准後向患者提供 NurOwn。

These include activities across manufacturing, commercial and medical affairs to engage with the physicians who treat ALS, and also early discussions with payers. In terms of how NurOwn would actually be delivered to ALS patients, the first step is to collect bone marrow from the patient, and this is then shipped to our manufacturing facility where the MSCs would undergo a series of steps to create the therapeutic product.

其中包括與治療 ALS 的醫生進行接觸的製造、商業和醫療事務活動，以及與付款人的早期討論。就 NurOwn 實際上如何交付給 ALS 患者而言，第一步是從患者身上收集骨髓，然後將其運送到我們的製造工廠，在那裡 MSC 將經歷一系列步驟來製造治療產品。

We're currently in discussions to be able to sign contracts with centers of excellence across the United States so that they will be set up to collect bone marrow from patients, and we can initiate the manufacturing process for each person's personalized treatment. We'll begin with 8 to 10 centers and then move to broader engagement with more centers.

我們目前正在討論與美國各地的卓越中心簽署合同，以便它們能夠從患者身上收集骨髓，並且我們可以啟動每個人的個人化治療的製造過程。我們將從 8 到 10 個中心開始，然後轉向與更多中心進行更廣泛的合作。

As we have outlined before, we're in the process of a targeted capability build to expand our team in preparation for anticipated growth. We want to be able to move quickly. So if we're successful in achieving the approval for NurOwn, we will have the infrastructure in place, and the wait for patients and families to gain access will be as short as possible.

正如我們之前概述的，我們正在進行有針對性的能力建設，以擴大我們的團隊，為預期的成長做好準備。我們希望能夠快速行動。因此，如果我們成功獲得 NurOwn 的批准，我們將擁有適當的基礎設施，並且患者和家屬獲得訪問權的等待時間將盡可能短。

We have made a number of hires and management changes so far in 2023. At the beginning of the year, Dr. Stacy Lindborg was promoted to co-CEO. Then early in the second quarter, we appointed Dr. Kirk Taylor as Executive Vice President and Chief Medical Officer. Kirk will lead the global medical affairs function and launch activities, including planned product launches, post-approval commercialization efforts, and deepening relationships with the medical community.

2023 年到目前為止，我們已經進行了多項招募和管理層變更。年初，Stacy Lindborg 博士晉升為聯合執行長。然後在第二季初，我們任命柯克泰勒博士為執行副總裁兼首席醫療官。柯克將領導全球醫療事務職能和發布活動，包括計劃的產品發布、批准後商業化工作以及深化與醫學界的關係。

More recently, in July, we appointed Dr. Bob Dagher as Executive Vice President and Chief Development Officer. Bob will be responsible for the portfolio strategy and advancement of clinical development plans towards regulatory approval, including the expansion of NurOwn into new diseases and the translation of pre-clinical research in the first-in-human trials.

最近，即 7 月，我們任命 Bob Dagher 博士為執行副總裁兼首席開發長。 Bob 將負責投資組合策略和臨床開發計劃的推進以獲得監管批准，包括將 NurOwn 擴展到新疾病以及將臨床前研究轉化為首次人體試驗。

He brings approximately 20 years of industry expertise in the development and approval of treatments for challenging neurological and rare diseases. He began his career at GSK and has served in leadership positions of science and medicine at companies such as Sanofi Genzyme and LabCorp Covance.

他在開發和批准具有挑戰性的神經系統疾病和罕見疾病的治療方法方面擁有大約 20 年的行業專業知識。他的職業生涯始於葛蘭素史克 (GSK)，並曾在賽諾菲健贊 (Sanofi Genzyme) 和 LabCorp Covance 等公司擔任科學和醫學領導職務。

Finally, we also made an important addition to our Board with the appointment of Nir Naor as a Board Member and the Chairman of the Audit Committee and member of the Governance, Nomination and Compensation Committee.

最後，我們還任命 Nir ​​Naor 為董事會成員、審計委員會主席以及治理、提名和薪酬委員會成員，對董事會進行了重要補充。

Nir brings over 20 years of global work experience as a CFO and Senior Finance Leader. He has a broad background that includes large pharma and biotech and has overseen organizations with up to $2.5 billion in sales and $1 billion in annual spend.

Nir 擁有 20 多年擔任財務長和高階財務主管的全球工作經驗。他擁有廣泛的背景，包括大型製藥和生物技術，並監管銷售額高達 25 億美元、年度支出高達 10 億美元的組織。

We are excited to expand our team with these and other talented individuals, and I know they share our vision and excitement around NurOwn's prospects. This expanded team is fully focused to prepare Brainstorm for the exciting future ahead.

我們很高興能與這些人和其他才華橫溢的個人一起擴大我們的團隊，我知道他們與我們分享對 NurOwn 前景的願景和興奮。這個擴大的團隊完全專注於為未來令人興奮的未來做好腦力激盪的準備。

I'll now turn the call over to Alla to discuss our financials. Alla?

我現在將電話轉給阿拉，討論我們的財務狀況。阿拉？

Thank you, Chaim. Cash, cash equivalents, and short-term bank deposits were approximately $0.75 million as at the end of June 2023, compared to approximately $3 million as of the end of December 2022. In July 2023, subsequent to the end of the quarter, the company raised net proceeds of approximately $7 million in the registered direct offering.

謝謝你，查姆。截至 2023 年 6 月末，現金、現金等價物和短期銀行存款約為 75 萬美元，而截至 2022 年 12 月底約為 300 萬美元。2023 年 7 月，本季末後，該公司透過註冊直接發行籌集了約700 萬美元的淨收益。

Research and development expenses for the three months ended June 30, 2023, and 2022 were approximately $2.8 million and $5.1 million, respectively. General and administrative expenses for the three months ended June 30, 2023, and 2022 were approximately $2.7 million and $2.5 million, respectively.

截至2023年6月30日及2022年6月30日止三個月的研發費用分別約為280萬美元及510萬美元。截至2023年6月30日和2022年的三個月的一般和管理費用分別約為270萬美元和250萬美元。

Net loss for the three months ended June 30, 2023, was approximately $5.3 million or $0.13 per share as compared to net loss of approximately $7 million or $0.19 per share for the three months ended June 30, 2022.

截至2023年6月30日止三個月的淨虧損約為530萬美元或每股0.13美元，而截至2022年6月30日止三個月的淨虧損約為700萬美元或每股0.19美元。

I'll turn it back to Chaim. Chaim?

我會把它轉回給Chaim。柴姆？

Thank you, Alla. I'll ask Michael Wood from LifeSci to read the questions we have received from investors. Michael?

謝謝你，阿拉。我將請 LifeSci 的 Michael Wood 閱讀我們從投資者那裡收到的問題。邁克爾？

Thanks, Chaim. The first question, is the submitted BLA for NurOwn definitely seeking full approval or accelerated approval?

謝謝，柴姆。第一個問題，NurOwn 提交的 BLA 肯定是尋求完全批准還是加速批准？

The BLA filed is seeking full approval. Thank you.

提交的 BLA 正在尋求全面批准。謝謝。

Thanks. And does the BLA includes data collected from patients that have been treated under the expanded access program and from the [Israeli HE] pathway?

謝謝。 BLA 是否包括從根據擴大准入計劃和[以色列 HE]途徑接受治療的患者收集的數據？

Yes, that is correct. Data from both programs were included in the BLA.

對，那是正確的。這兩個項目的數據均包含在 BLA 中。

Do you still intend to publish your biomarker manuscript?

您還打算發表您的生物標記手稿嗎？

Absolutely. The biomarker data is a compelling part of our evidence, which provides strong support of the clinical data. And we can confirm the paper is under review at a highly regarded journal. The senior authors are Dr. Bob Brown and Dr. Merit Cudkowicz, and the paper includes other leading researchers and scientists.

絕對地。生物標記數據是我們證據中引人注目的一部分，為臨床數據提供了強有力的支持。我們可以確認這篇論文正在備受推崇的期刊上接受審查。資深作者是 Bob Brown 博士和 Merit Cudkowicz 博士，該論文還包括其他領先的研究人員和科學家。

Thanks. The next question relates to the Gordon Conference. Why did you only recently decide to look at baseline characteristics of patients and make this presentation at Gordon? And did the results change substantially once you've counted the baseline characteristics?

謝謝。下一個問題與戈登會議有關。為什麼您最近才決定研究患者的基線特徵並在戈登進行這次演講？一旦計算了基線特徵，結果是否會發生重大變化？

And then having listened to Stacy's discussion this morning, I have an additional question I'm going to add, and that is we're intrigued by the word precision that Stacy used in her prepared remarks. Can you please explain what this means?

今天早上聽了史黛西的討論後，我還有一個問題要補充，那就是我們對史黛西在她準備好的發言中使用的「精確」這個詞很感興趣。您能解釋一下這是什麼意思嗎？

Stacy, I'll have you answer this question.

史黛西，我會讓你回答這個問題。

Okay. So to the first question, why adjust for baseline characteristics now, basically, this is an example of emerging science.

好的。所以對於第一個問題，為什麼現在要調整基線特徵，基本上，這是新興科學的一個例子。

If you look at the public documents from tofersen to AdCom, you'll see that the FDA did a lot of work exploring the importance of disease covariates, including all of the baseline disease covariates that we prespecified in our efficacy analyses that I actually spoke about in my prepared remarks. And they did this as they were analyzing tofersen data.

如果您查看從 tofersen 到 AdCom 的公開文件，您會發現 FDA 做了很多工作來探索疾病協變量的重要性，包括我們在我實際上談到的功效分析中預先指定的所有基線疾病協變量在我準備好的發言中。他們在分析托弗森數據時這樣做了。

Also, as I referenced earlier, the FDA issued a final guidance on adjusting for covariates in randomized clinical trials, which was very timely and provided important perspective. In fact, when we reviewed the guidance, which focused on prognostic baseline covariates, what stood out to us was that sponsors should prospectively specify covariate-adjusted analyses.

此外，正如我之前提到的，FDA 發布了關於調整隨機臨床試驗中協變量的最終指南，該指南非常及時，並提供了重要的視角。事實上，當我們審查專注於預後基線協變量的指南時，我們注意到申辦者應該前瞻性地指定協變量調整分析。

Therefore, we thought it logical to use the covariates specified in our Phase 3 statistical analysis plan. So the guideline also noted that covariate adjustment was acceptable even if baseline covariates were strongly associated with each other. So this guidance, combined with the importance the FDA placed on these covariates in tofersen's review, led us to explore the importance of these covariates in our data.

因此，我們認為使用第三階段統計分析計畫中指定的協變數是合乎邏輯的。因此，指南也指出，即使基線協變量彼此密切相關，協變量調整也是可以接受的。因此，這份指南，再加上 FDA 在 tofersen 審查中對這些協變量的重視，引導我們探索這些協變量在我們的數據中的重要性。

As a side note, in the analysis that we ran, we also used the model that FDA used with tofersen data. And in the cases where this was done, the [significance that has helped] across our data is quite robust.

順便說一句，在我們進行的分析中，我們也使用了 FDA 與 tofersen 資料一起使用的模型。在完成此操作的情況下，我們的數據[有幫助的意義]是相當強大的。

Michael, if I understood your question at the end, you wanted to know what I meant by the word precision. Let me first recall this statement I made earlier. So I referenced that in the analysis of our biomarker data, we can reflect the treatment effect more accurately when we account for baseline heterogeneity of patients.

邁克爾，如果我最後理解了你的問題，你想知道我所說的精確這個詞是什麼意思。首先讓我回顧一下我之前的發言。所以我提到，在我們的生物標記數據分析中，考慮到患者基線異質性，我們可以更準確地反映治療效果。

So in other words, by adding these characteristics, which really help identify ways that the disease is variable across patients, it brings precision to the estimate of treatment.

換句話說，透過添加這些特徵，確實有助於確定疾病在患者之間的變異方式，從而為治療估計帶來精確性。

So here, when I use this word, precision, what I mean is that the model with disease covariates included in it and these covariates' influence -- can influence the rate of disease progression. This will have a better ability to capture variability observed in the data. And the significance of these covariates tells us that this is the right way to analyze the data. Otherwise, you're ignoring important information in the analysis.

所以在這裡，當我使用「精確度」這個詞時，我的意思是包含疾病協變量的模型以及這些協變量的影響——可以影響疾病進展的速度。這將能夠更好地捕捉數據中觀察到的變異性。這些協變數的重要性告訴我們，這是分析資料的正確方法。否則，您將忽略分析中的重要資訊。

The last part of the question was how the results compared across the model that had baseline covariates versus one, the model that did not. The biomarker results from the model -- from both models actually are very similar with no conclusions changing substantially for any biomarker.

問題的最後一部分是如何比較具有基線協變量的模型與沒有基線協變量的模型的結果。該模型得出的生物標記結果實際上非常相似，任何生物標記的結論都沒有重大變化。

There were two biomarkers that were already trending towards a significant treatment effect. One was neurofilament light; the other was neuroprotective biomarker HGF. And accounting for these disease characteristics resulted in the P value dropping just below the conventional level of 0.05.

有兩種生物標記已經趨於產生顯著的治療效果。一種是神經絲光；另一種是神經絲光。另一個是神經保護生物標記 HGF。考慮到這些疾病特徵，P 值略低於 0.05 的常規水平。

But even for these two biomarkers, the overall pattern in the treatment effect as well as the percent change from baseline in both arms is very similar to the results of the model that didn't adjust for the terms. The estimate of the treatment effect just had more precision because it could take into account important information that also includes clinical outcomes in addition to treatment.

但即使對於這兩種生物標誌物，治療效果的整體模式以及兩組相對於基線的百分比變化也與未針對這些條件進行調整的模型的結果非常相似。對治療效果的估計更加精確，因為它可以考慮重要訊息，其中還包括除治療外的臨床結果。

Thanks, Stacy. Next question, do you intend to proceed with a confirmatory clinical trial?

謝謝，史黛西。下一個問題，您打算進行驗證性臨床試驗嗎？

Yes, we have definite plans to proceed with a confirmatory trial. It's for months now that we have been meeting with a steering committee of leading clinicians and statisticians. We intend to share more after we get input from the FDA.

是的，我們有明確的計劃進行驗證性試驗。幾個月來，我們一直在與主要臨床醫生和統計學家組成的指導委員會舉行會議。我們打算在收到 FDA 的意見後分享更多資訊。

In this regard, I would like to really share that we're very thankful for the California Institute for Regenerative Medicine firm that reached out to us, and they asked us that they would be interested that we submit our application for such a trial. Thank you.

在這方面，我想真正分享的是，我們非常感謝加州再生醫學研究所與我們聯繫，他們詢問我們是否有興趣我們提交此類試驗的申請。謝謝。

Is there a reason that you're granted a different AdCom from the AdCom that oversaw the Amylyx and Biogen drugs? Do you think this is a good or bad sign that you are being reviewed at a different AdCom?

您獲得與監管 Amylyx 和 Biogen 藥物的 AdCom 不同的 AdCom 是否有原因？您認為這是好兆頭還是壞兆頭，表示您正在接受不同 AdCom 的審查？

Yeah. So the designation of the advisory committee that advises FDA for an application under review is determined by the specific center of the FDA center that the application is filed with. The Relyvrio and Qalsody were both submitted as new drug applications NDA to CDER or the Center for Drug Evaluation and Research, while NurOwn, being a biological product -- a stem cell product, was submitted as a biologic license application to CBER or the Center for Biologics Evaluation and Research.

是的。因此，為 FDA 審查申請提供建議的諮詢委員會的指定是由提交申請的 FDA 中心的具體中心決定的。 Relyvrio 和 Qalsody 均作為新藥申請 NDA 提交給 CDER 或藥物評估與研究中心，而 NurOwn 是一種生物製品（幹細胞產品），作為生物製品許可申請提交給 CBER 或藥物評估與研究中心。生物製品評估和研究。

Each center has multiple AdComs. For example, CBER has four. NurOwn will be reviewed by CBER's cellular tissue and gene therapies advisory committee.

每個中心都有多個 AdCom。例如，CBER 有四個。 NurOwn 將接受 CBER 細胞組織和基因治療諮詢委員會的審查。

If anyone is interested to look in deeper to this, there's a document called the inter-center agreement between the CDER and the CBER assigned to each center's jurisdiction for regulation of drug and biological products and combination of drugs and biological products. And it describes those product characteristics or medical indications that would require a collaborative review of effort by the two centers.

如果有人有興趣更深入地了解這一點，可以閱讀一份名為CDER 和CBER 之間的中心間協議的文件，該協議分配給每個中心的管轄範圍，負責監管藥品和生物製品以及藥品和生物製品的組合。它還描述了需要兩個中心合作審查的產品特徵或醫學適應症。

Thanks. The next question relates to clinical manufacturing controls or CMC. Have you been able to submit amendments to address the CMC items identified by the FDA in their initial RTF letter? And if so or if not, do you anticipate any impact on the PDUFA date?

謝謝。下一個問題涉及臨床生產控製或 CMC。您是否能夠提交修正案以解決 FDA 在最初的 RTF 信中確定的 CMC 項目？如果是這樣或否，您預計會對 PDUFA 日期產生任何影響嗎？

So yeah, definitely. As we have shared, and I'll confirm this again, the FDA has allowed us to submit amendments, and we have submitted those amendments. Sure. Thank you.

所以是的，絕對是。正如我們所分享的，我將再次確認這一點，FDA 允許我們提交修正案，我們已經提交了這些修正案。當然。謝謝。

And have you been having any conversations directly with the FDA while the BLA has been under review?

在 BLA 接受審查期間，您是否曾直接與 FDA 進行過任何對話？

Yes. As is typical for a BLA under review, we have regularly occurring interactions with the FDA. We received quite a few requests for informations, which we have responded to in a timely fashion. We also were able to share presentations in addition to other interactions.

是的。正如正在審查的 BLA 的典型情況一樣，我們經常與 FDA 互動。我們收到了不少資訊請求，我們都及時回覆了。除了其他互動之外，我們還能夠分享簡報。

You reported that around 25% of patients in your Phase 3 study had a baseline value below 25. And in these patients, further declines could not be measured because the items reached zero. You referred to this as the floor effect. Can you please expand on the floor effect, and do you have any biomarker data for these participants?

您報告說，在您的 3 期研究中，大約 25% 的患者的基線值低於 25。在這些患者中，無法測量進一步的下降，因為這些項目達到了零。您將其稱為地板效應。能否詳細介紹一下地板效應，您有這些參與者的生物標記數據嗎？

Thank you. Stacy, please?

謝謝。史黛西，請嗎？

Sure. I want to start by just reflecting on the fact that the ALSFRS-R remains the best outcome measure that we have today. But like any bounded scale, it has limitations. And in the group of participants asked about in this question who were in the bottom half of the scale, there was a high rate of participants with ALSFRS-R items, specifically in the fine and gross motor subdomain that started at zero with approximately 40% on starting at zero across all six items.

當然。首先，我想反思一下這樣一個事實：ALSFRS-R 仍然是我們今天擁有的最佳結果衡量標準。但與任何有界尺度一樣，它也有其限制。在這個問題中被問到的處於量表下半部分的參與者群體中，有很高比例的參與者擁有ALSFRS-R 項目，特別是在從零開始的精細和粗大運動子領域，大約有40 %所有六個項目都從零開始。

The rate of zero values, especially on the fine and gross motor, is problematic to measuring the treatment effect in a trial because it's expected that the fine and gross motor domains account for about 70% of decline observed in trials. This therefore confounds the ability to show a treatment effect as the ALSFRS-R can't measure further decline once items reached zero.

零值率，尤其是精細運動和粗大運動的零值率，對於衡量試驗中的治療效果來說是有問題的，因為預計精細和粗大運動領域約佔試驗中觀察到的下降的 70%。因此，這混淆了顯示治療效果的能力，因為一旦項目達到零，ALSFRS-R 就無法測量進一步下降。

So the question about biomarker data in these participants, we have looked at biomarker data in these participants. And in fact, at the Gordon Conference, we reported first that we observed significant improvements on ALS biomarkers with NurOwn versus placebo in all trial participants. And this was important across the three important pathways that I referenced in my opening remarks: neuroinflammation, neurodegeneration, and neuroprotection.

關於這些參與者的生物標記數據的問題，我們研究了這些參與者的生物標記數據。事實上，在戈登會議上，我們首先報告說，我們在所有試驗參與者中觀察到 NurOwn 與安慰劑相比 ALS 生物標記的顯著改善。這對於我在開場白中提到的三個重要途徑非常重要：神經發炎、神經退化和神經保護。

We in fact see very similar treatment patterns in participants with baseline scores 25 and below on the ALSFRS-R. And what this suggests is that NurOwn is biologically active in the overall population that was studied in the trial, which includes participants with advanced ALS disease where the scale, the ALSFRS-R scale, demonstrated measurement challenges.

事實上，我們在 ALSFRS-R 基線分數 25 及以下的參與者中發現了非常相似的治療模式。這表明 NurOwn 在試驗中研究的總體人群中具有生物活性，其中包括患有晚期 ALS 疾病的參與者，其中 ALSFRS-R 量表顯示了測量挑戰。

Thanks, Stacy. Next question relates to your clinical pipeline. Brainstorm has said that it's working on the use of its product for other indications. Investors have been hearing about this now for years. Please provide some specificity with respect to what working on it means.

謝謝，史黛西。下一個問題與您的臨床管道有關。 Brainstorm 表示正在研究將其產品用於其他適應症。投資者多年來一直聽說這一點。請具體說明其工作的意義。

Well, thank you. I'll ask Dr. Kirk Taylor to take this question, please.

嗯，謝謝。請柯克·泰勒博士回答這個問題。

Great, Chaim, thank you. Sure. Well, we completed a Phase 2 study evaluating NurOwn as a treatment for progressive MS and announced positive results in 2021. We have worked with neurologists and statisticians with deep expertise in MS to design the next trial and have a solid protocol concept prepared that builds on the completed Phase 2a study.

太好了，查姆，謝謝你。當然。我們完成了一項2 期研究，評估NurOwn 作為進行性多發性硬化症的治療方法，並於2021 年宣布了積極的結果。我們與在多發性硬化症方面擁有深厚專業知識的神經科醫生和統計學家合作，設計了下一個試驗，並準備了一個可靠的方案概念，該概念建立在已完成的 2a 期研究中。

We've also prepared a protocol concept designed to study the impact of NurOwn in Alzheimer's disease in the context of the unmet need that remains with the approval of treatments that remove amyloid plaque, consulting with leading experts, and that's NurOwn in Alzheimer's disease.

我們也準備了一個方案概念，旨在研究NurOwn 在阿茲海默症中的影響，在消除澱粉樣斑塊的治療方法獲得批准後，仍存在未滿足的需求，並諮詢了領先的專家，這就是NurOwn 在阿茲海默症中的作用。

Designed to the question addressed here is, though, in patients for amyloid plaque has been removed, could NurOwn increase cognitive function above baseline levels? That's the question. NurOwn's mechanism of action supports our view that it may have broad applications in neurodegenerative disease. However --

不過，這裡要解決的問題是，在澱粉樣蛋白斑塊已被移除的患者中，NurOwn 能否將認知功能提升到基線以上？這就是問題所在。 NurOwn 的作用機制支持我們的觀點，即它可能在神經退化性疾病中具有廣泛的應用。然而 -

Kirk?

柯克？

I'm sorry that I've been cut -- however, like many of our peers in biotech industry, we need to prioritize resources and focus those programs that could potentially benefit patients in the near term and create value for our stakeholders. At this point, we are focused primarily on the ALS program and getting approval in that indication. We intend to move forward with other programs as resources allow. Thank you.

我很抱歉我被裁掉了——但是，像生物技術行業的許多同行一樣，我們需要優先考慮資源，並重點關注那些可能在短期內造福患者並為我們的利益相關者創造價值的項目。目前，我們主要關注 ALS 計劃並獲得該適應症的批准。我們打算在資源允許的情況下推進其他計劃。謝謝。

Thank you. I have one final question. Did Brainstorm finalize on the follow-on offering with Maxim for $7.5 million?

謝謝。我還有最後一個問題。 Brainstorm 是否最終確定了與 Maxim 一起以 750 萬美元的價格進行後續發行？

Yeah, in addition to the PR on this matter, as is common practice, we did publish an 8-K. Just to provide some more color on this. We will continue to explore the best ways for finance. We'll have multiple options to finance going forward, and the company will be quite opportunistic to utilize the most favorable opportunities that comes our way at the time of need. Michael?

是的，除了關於此事的 PR 之外，按照慣例，我們還發布了 8-K。只是為了為此提供更多顏色。我們將繼續探索金融的最佳途徑。我們將有多種融資選擇，公司將非常機會主義地利用我們在需要時出現的最有利的機會。邁克爾？

And that's the final question.

這是最後一個問題。

Thank you so much. Jenny, would you open for any additional questions?

太感謝了。珍妮，您還有其他問題嗎？

Yeah, no problem. (Operator Instructions) Jason McCarthy, Maxim Group.

是的，沒問題。 （操作員說明）Jason McCarthy，Maxim Group。

Hi, all. Thanks for taking the question. Really looking forward to that AdCom in September. And about that AdCom, do you expect -- based on your covariate analysis of the five covariates and what you've shown around NFL, particularly in that presentation in July, do you expect the same questions that Biogen had gotten where there was the vote on NFL, nine to zero, but there was differences in the voting, three yes, five no, on the full approval, I guess, requiring a confirmatory study. Do you expect this similar set of question?

大家好。感謝您提出問題。真的很期待 9 月的 AdCom。關於AdCom，你是否期望——根據你對五個協變量的協變量分析以及你在NFL 中展示的內容，特別是在7 月份的演示中，你是否期望與百健（Biogen）在投票時得到的相同問題在 NFL 中，九比零，但投票結果存在差異，三人贊成，五人反對，我想，完全批准，需要進行驗證性研究。您期待類似的問題嗎？

Thank you very much. Stacy?

非常感謝。史黛西？

Hi, Jason. It's great to hear from you. My thinking about that is this is a different AdCom, a different FDA center, a different application, very different mechanism of action. I think what each of the drug programs was presenting is their evidence also is quite different. So we both bring interesting insights into neurofilament light and the association with the ability to actually mention and show that reductions in neurofilament light are results in an association with the improved clinical outcomes.

嗨，傑森。很高興收到你的來信。我的想法是，這是一個不同的 AdCom、一個不同的 FDA 中心、一個不同的應用程式、非常不同的作用機制。我認為每個藥物項目所提供的證據也截然不同。因此，我們都對神經絲光以及與實際提及和證明神經絲光的減少與臨床結果改善相關的能力的關聯提出了有趣的見解。

It is a strength, but I've learned over the course of my career to not assume anything with regard to the regulators. We'll actually get the questions out there, close to the time of the AdCom. And I think the questions that we're asked were relevant, but we'll know for certain what our questions are right before the AdCom.

這是一種優勢，但我在職業生涯中學會了不要對監管機構承擔任何責任。實際上，我們會在 AdCom 會議召開前提出問題。我認為我們提出的問題是相關的，但我們會在 AdCom 之前確切地知道我們的問題是什麼。

During that AdCom, as part of the presentation, will it be made more of a point on the safety aspects of NurOwn, given that it is an autologous cell therapy, it's not genetically manipulated and that it is a far safer approach apparently than other drugs for ALS, including the Biogen drug?

在 AdCom 會議期間，作為演示的一部分，是否會更多地強調 NurOwn 的安全性，因為它是一種自體細胞療法，不是基因操縱的，並且顯然比其他藥物安全得多對於 ALS，包括 Biogen 藥物？

Stacy?

史黛西？

Yeah, so we will present the full set of data, efficacy and safety. And Jason, we share your confidence in the safety of NurOwn, not only in the data we generated but as a result of the way that our product is made. And we will provide a compelling overview of all data at our presentation.

是的，所以我們將展示全套數據、功效和安全性。 Jason，我們與您一樣對 NurOwn 的安全性充滿信心，這不僅體現在我們產生的資料上，也體現在我們產品的製造方式上。我們將在演示中提供所有數據的令人信服的概述。

And just lastly, a brief question on the potential commercialization plan. I know it's early, but from a pricing perspective, tofersen, priced at around $14,000 or so just north of that per treatment, but it's about $200,000 all called for a year, is that a similar pricing strategy that you could expect for a cell therapy?

最後，一個關於潛在商業化計劃的簡短問題。我知道現在還為時過早，但從定價角度來看，tofersen 的定價約為每次治療 14,000 美元左右，但一年的費用約為 20 萬美元，這與細胞療法的定價策略類似？

And just from a launch perspective, Chaim, you had mentioned getting possibly 8 to 10 centers initially for bone marrow collection. How large of a sales force would you need to complete your initial commercialization plans?

Chaim，從啟動的角度來看，您提到最初可能會建立 8 到 10 個骨髓採集中心。您需要多少銷售人員才能完成最初的商業化計畫？

Yeah. So thank you very much. Many of these questions is premature for us to answer for regulatory reasons, as you know. But I like the assumptions you're laying out. And I think what will be very important is to find the centers of excellence doing not only the bone marrow aspirations but the intrathecal injections, which some of these, like [Sarepta] treatments and [Topican] treatments, really helps out.

是的。非常感謝。如您所知，出於監管原因，我們回答其中許多問題還為時過早。但我喜歡你提出的假設。我認為非常重要的是找到不僅進行骨髓穿刺而且進行鞘內注射的卓越中心，其中一些治療，例如 [Sarepta] 治療和 [Topican] 治療，確實有幫助。

And more and more centers have that expertise. And that's what we'll be focusing and probably will start with the centers of the trial, which already have a lot of experience with our product. But we're also talking to many other geographical centers and make sure that patients from other geographies have a center close nearby to where they are.

越來越多的中心擁有這種專業知識。這就是我們將關注的重點，並且可能會從試驗中心開始，這些中心已經對我們的產品擁有豐富的經驗。但我們也在與許多其他地理中心進行交談，並確保來自其他地區的患者在他們所在的地方附近有一個中心。

Just a comment to a previous question you asked, and Stacy answered a little bit, is of course, we believe that our clinical data set, even though the primary endpoint did not hit statistical significance, we think that the body of evidence, moving forward, we are able to show statistically significant results once we're able to show and dive into -- more deeper into the data set, which you spent a lot of time and I don't want to repeat it for you.

只是對您之前提出的問題的評論，史黛西回答了一點，當然，我們相信我們的臨床數據集，即使主要終點沒有達到統計顯著性，我們認為證據體正在向前推進，一旦我們能夠展示並深入研究資料集，我們將能夠展示統計上顯著的結果，您花了很多時間，我不想為您重複。

Therefore, I think that the question will be more focused on clinical, why the biomarker data gives strong support to what we're seeing in the clinical as it covers even for the part of the score where we think it's not sensitive in the more advanced patients. But when you are able to eliminate the advanced patients, we see both the primary and secondary endpoints statistical significant results.

因此，我認為問題將更加集中在臨床上，為什麼生物標記數據為我們在臨床中看到的情況提供了強有力的支持，因為它甚至涵蓋了我們認為在更高級的情況下不敏感的分數部分。患者。但是，當您能夠消除晚期患者時，我們會看到主要和次要終點均具有統計顯著性結果。

Of course, we're not going to lay it out here. That's what we're going to do at the AdCom. But thank you very much for those questions, Jason.

當然，我們不會在這裡展開。這就是我們在 AdCom 要做的事情。但非常感謝你提出這些問題，傑森。

Chaim and Stacy, thank you.

柴姆和史黛西，謝謝你們。

Sure.

當然。

Thank you very much. (Operator Instructions) Okay, we don't appear to have any further questions in the queue. I can hand back over for closing comments.

非常感謝。 （操作員說明）好的，隊列中似乎沒有其他問題。我可以交回結束評論。

Thank you. I really appreciate that. It looks like Stacy did a wonderful job laying out the plan, and there's no additional questions. So let's -- we had a long call this morning, so let's give back the time to everyone listening. I want to thank you again for listening in.

謝謝。我真的很感激。看起來史黛西製定的計畫非常出色，沒有其他問題了。所以，今天早上我們進行了一次長時間的通話，所以讓我們把時間還給每個聆聽者。我想再次感謝您的收聽。

In August -- middle of August to have so many investors listen again, it shows the importance to our investors of our plan forward, and we really thank you for listening in today. Thank you very much. Jenny, back to you.

八月中旬，有這麼多投資者再次收聽，這表明了我們未來計劃對投資者的重要性，我們非常感謝您今天的收聽。非常感謝。珍妮，回到你身邊。

Thank you, Chaim. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

謝謝你，查姆。今天的電話會議到此結束。此時您可以斷開電話線並度過美好的一天。感謝您的參與。