Burning Rock Biotech Ltd (BNR) 2023 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Before we begin, I would like to remind you that this conference call contains forward-looking statements within the meaning of Section 21E of Securities Exchange Act of 1934 as amended and as defined in the US Private Securities Litigation Reform Act of 1995.

    在我們開始之前,我想提醒您,本次電話會議包含經修訂的 1934 年證券交易法第 21E 條含義以及 1995 年美國私人證券訴訟改革法案中定義的前瞻性陳述。

  • These forward-looking statements can be identified by terminology such as will, expects, anticipates, future, intends, plans, believes, estimates, target, confident and similar statements. Statements that are not historical facts, including statements about Burning Rock's beliefs and expectations are forward-looking statements.

    這些前瞻性陳述可以透過意願、期望、預期、未來、打算、計劃、相信、估計、目標、自信和類似陳述等術語來識別。非歷史事實的陳述,包括有關燃石的信念和期望的陳述,均為前瞻性陳述。

  • Such statements are based upon management's current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock's control.

    此類聲明是基於管理層當前的預期以及當前的市場和營運狀況,並涉及涉及已知或未知風險、不確定性和其他因素的事件,所有這些因素都難以預測,其中許多因素超出了燃石科技的控制範圍。

  • Yusheng Han - Founder, Chairman of the Board of Directors & CEO

    Yusheng Han - Founder, Chairman of the Board of Directors & CEO

  • Hey, it this my turn? Well, okay. This is Yusheng Han from Burning Rock, I'm the CEO and Founder. And today you also have our CFO, Leo Li, and our CTO, Joe Zhang online. And today we have a brief introduction of [recent progress], and then I'll hand on to Leo, talking about the financials and then Joe talking about our pipeline program.

    嘿,輪到我了嗎?哦,那好吧。我是燃石醫學的韓雨生,我是執行長兼創辦人。今天我們的財務長 Leo Li 和我們的技術長 Joe 張也在線上。今天我們簡單介紹一下[最新進展],然後我將由Leo 談論財務狀況,然後Joe 談論我們的管道計劃。

  • So let's turn to page 3, which shows that what Burning Rock doing. How we started from therapy selection and expanded to early detection MRD and biopharma business. And so far that's our business, our construction.

    讓我們翻到第三頁,它顯示了 Burning Rock 在做什麼。我們如何從治療選擇開始,擴展到早期檢測 MRD 和生物製藥業務。到目前為止,這就是我們的業務、我們的建設。

  • Let's turn to page 4, which is the page that I think most of the investors care about most, that's about breakeven. And so we set a goal to breakeven in terms of non-GAAP profit minus SG&A. And we say that in Q2 this year we have -- this is the first time in Burning Rock to reach the goal.

    讓我們翻到第四頁,這是我認為大多數投資者最關心的頁面,這是關於損益平衡的。因此,我們設定的目標是在非 GAAP 利潤減去 SG&A 後達到損益兩平。我們說,在今年第二季度,我們——這是燃石樂隊第一次實現了這一目標。

  • Well in Q3, actually, there is some industry disruption, you know that, even most of the medical conferences or meetings would hold anomaly. So in Q3, it is a little be impacted by this event and the profit dropped to the negative part, which is a negative 9.9 -- sorry, RMB8.9 million. But we are still moving to the breakeven level, especially I think that this kind of volatility will pass by the end of this year.

    那麼在第三季度,實際上,有一些行業中斷,你知道,甚至大多數醫學會議或會議都會異常舉行。所以到了第三季度,受到這事件的影響有點大,利潤跌到了負數,就是負數9.9——對不起,890萬元。但我們仍在朝著盈虧平衡水平邁進,特別是我認為這種波動將在今年年底過去。

  • So let's turn to page 5, that we set a goal to breakeven sometime this year. And we think that we are moving toward that direction very firmly and without the disruption.

    讓我們翻到第 5 頁,我們設定了今年某個時候實現收支平衡的目標。我們認為我們正在非常堅定地朝著這個方向前進,而且不會受到干擾。

  • And in terms of the therapy selection, despite of the industry disruption, we still continue to grow in the in-hospital model, which means that the in-hospital revenues has 10% year-on-year growth. And the part of it has been impacted with the central-lab model.

    而在治療選擇方面,儘管產業受到衝擊,我們仍在院內模式上持續成長,這意味著院內收入較去年同期有10%的成長。其中一部分受到了中央實驗室模型的影響。

  • In MRD, we have a strong clinical validation publications with the METAL study of lung cancer published in Cancer Cell, which is a big milestone for our MRD study. And we know that the other studies, for example, like colon cancer and esophageal cancer are on way.

    在 MRD 方面,我們擁有強大的臨床驗證出版物,其中在 Cancer Cell 上發表了肺癌的 METAL 研究,這是我們 MRD 研究的一個重要里程碑。我們知道其他研究,例如結腸癌和食道癌正在進行中。

  • For biopharma, despite of the struggling time of capital market for our biopharmars, we still have a strong growth showing our systematic value of Burning Rock was revenue growth of 31% year-on-year. And our backlog too keeps growing. And one thing to mention is that we just signed a CDx contract with BI.

    對於生物製藥來說,儘管我們的生物製藥公司在資本市場陷入困境,但我們仍然有強勁的成長,這表明我們燃石的系統價值是營收年增31%。我們的積壓訂單也在不斷增加。值得一提的是,我們剛剛與 BI 簽署了一份 CDx 合約。

  • In terms of our early detection there is a big step -- I mean, a big milestone for that. We got a breakthrough device designation granted by China National Medical Product Administration, which is NMPA. And we are the only -- our multi-cancer early detection only test that has received a BDD from both FDA and NMPA.

    就我們的早期檢測而言,我們邁出了一大步——我的意思是,這是一個重要的里程碑。我們獲得了中國國家藥品監督管理局(NMPA)授予的突破性器械認定。我們是唯一獲得 FDA 和 NMPA BDD 的多癌症早期檢測測試。

  • And let's turn to Page 6 to explain that the how the industry volatility impact our volume. You can see that the central-lab model has been impact a negative 31% while for in-hospital model is still growing in terms of volume.

    讓我們翻到第 6 頁來解釋產業波動如何影響我們的銷售量。您可以看到,中心實驗室模型的影響下降了 31%,而醫院內模型的數量仍在增加。

  • So we're seeing that -- yeah, and that actually impact our competitors much more than Burning Rock because our Burning Rock is the only company that our in-hospital model represents more than half of our revenues.

    所以我們看到了——是的,這實際上對我們的競爭對手的影響比燃石要大得多,因為我們燃石是唯一一家醫院模式占我們收入一半以上的公司。

  • And then I'll turn to Leo about our financials.

    然後我會向 Leo 詢問我們的財務狀況。

  • Leo Li - Director & CFO

    Leo Li - Director & CFO

  • Let's move on to Page 7. As Yusheng mentioned earlier, the whole China healthcare industry had a disruption during the quarter. And what I meant for us was actually two diverging trends, which actually accelerated the path that we were already on.

    讓我們轉到第七頁。正如餘生之前提到的,整個中國醫療保健行業在本季度出現了混亂。我對我們來說實際上是兩種不同的趨勢,這實際上加速了我們已經走上的道路。

  • So if you look at central-lab, that was down, heavily down 41% on a year-over-year basis in the third quarter. [In-hospital] channel continued to grow and it grew 10% year-over-year, which is rare in the diagnostics industry or at least in our specialty industry in China.

    因此,如果你看看central-lab,你會發現,第三季比去年同期大幅下降了 41%。 【院內】通路持續成長,較去年成長10%,這在診斷產業或至少在我們中國的專科產業是很少見的。

  • So I think that continues to improve the value of the in-hospital segments, where the real value or the profits is at central-lab, as we mentioned earlier is being shifted more towards in-hospital. I think the events in the third quarter only accelerated that and that moved us even more on the right track in terms of moving the mainstream of our businesses towards the in-hospital segment.

    因此,我認為這將繼續提高住院部分的價值,其中真正的價值或利潤位於中心實驗室,正如我們之前提到的,正在更多地轉向醫院內。我認為第三季發生的事件只會加速這一進程,使我們在將業務主流轉向醫院內領域方面更加正確的軌道。

  • So at some point last year, we were seeing more in-hospital segments by volume. And you can see in the third quarter, we're actually in-hospital, represented the largest segment overtaking central-lab. So I think with that transition completes some point down the road, our volume and revenue math trends will match again as we complete this transition.

    因此,去年的某個時候,我們看到院內細分市場的數量增加。你可以看到,在第三季度,我們實際上在醫院,代表了超過中心實驗室的最大細分市場。因此,我認為隨著過渡的完成,我們的銷售和收入數學趨勢將在我們完成這一過渡時再次匹配。

  • Then moving on, we can see that pharma services still had a strong growth quarter in the third quarter. Revenues grew 31% on a year-over-year basis. So we are very pleased with that result. Our backlog continued to grow, particularly from multinational companies. And Yusheng gave an example of a recent win in his remarks. So we're very pleased with the progress and the outlook that we have in the sector.

    再往前看,我們可以看到醫藥服務在第三季仍然有強勁的成長。營收年增 31%。所以我們對這個結果非常滿意。我們的積壓訂單持續成長,尤其是來自跨國公司的訂單。而餘生在講話中舉了最近一次勝利的例子。因此,我們對該行業的進展和前景感到非常滿意。

  • Overall, because of the industry impacts and the drop in central-lab, our revenue was down 17% on a year-over-year basis. And we're very conscious of this trend and we are managing our expense or our cost base appropriately in according to the new industry setup.

    總體而言,由於行業影響和中心實驗室的下降,我們的收入比去年同期下降了 17%。我們非常意識到這一趨勢,我們正在根據新的行業設定適當地管理我們的費用或成本基礎。

  • So I think we had a temporary dip in our operating margins for the third quarter, and that should turn for the better in the quarters down the road. So measured on a non-GAAP basis by gross profits minus SG&A and we hit a positive territory in the second quarter of (technical difficulty) in the third quarter. And we were looking to turn this to a positive number again at some quarter down the road. So we are working towards that.

    因此,我認為我們第三季的營業利潤率暫時下降,但在接下來的幾季中應該會好轉。因此,按照非公認會計原則(non-GAAP)衡量,即毛利減去銷售管理費用(SG&A),我們在第三季(技術難度)第二季達到了正值。我們希望在未來的某個季度再次將其變為正數。所以我們正在為此努力。

  • And we have done some [rejigging] in the recent time periods to make sure that we're on the right track. So our [operating hit] or our operating loss did widen little bit in the third quarter compared to the second quarter. And we're aware of that. We've made the adjustments at towards the end of September, and we hope to be on a better track going forward.

    我們在最近一段時間內做了一些[調整],以確保我們走在正確的軌道上。因此,與第二季相比,我們的[營運打擊]或營運虧損在第三季略有擴大。我們知道這一點。我們在九月底就進行了調整,希望未來能走上更好的軌道。

  • Notably, we are also managing our operating cash flows with managing our expenses, our cash expenses very carefully. And you can see the net operating cash outflow this quarter has dropped to 70 -- up to RMB47 million per quarter.

    值得注意的是,我們也非常仔細地管理我們的營運現金流量和管理我們的費用,我們的現金支出。你可以看到本季的營運現金流淨流出已降至 70——每季高達 4,700 萬元人民幣。

  • And if you look at our operating margins, if you look at our sales and marketing expenses as a percent of revenue despite the drop in revenues, I mean our sales and marketing expenses were 45% of our revenues, similar to 44% that we achieved in the second quarter.

    如果你看看我們的營業利潤率,如果你看看我們的銷售和行銷費用佔收入的百分比,儘管收入下降了,我的意思是我們的銷售和行銷費用佔收入的45%,與我們實現的44% 類似。在第二季。

  • And as we think industry volume normalizes down the roads, our operating margins should improve that will help to get back to the positive non-GAAP territory in the quarters down the road. So that's a quick recap of the P&L for the quarter.

    由於我們認為行業銷售未來將趨於正常,我們的營業利潤率應該會有所改善,這將有助於在未來幾季恢復非公認會計準則下的正值。這是本季損益表的快速回顧。

  • And I think we should also mention our cash position as that's been a focus if we go to Page 8. So we had cash outflow of about RMB532 million in the year of 2022. That's not our run rates for 2023. Our guidance at the start of this year was about RMB400 million outflow.

    我認為我們也應該提到我們的現金狀況,因為如果我們翻到第8 頁,這就是一個焦點。因此,我們在2022 年的現金流出約為5.32 億元人民幣。這不是我們2023 年的運行率。我們一開始的指導今年流出約4億元。

  • And you can see in three quarters so far this year, we had an outflow of about RMB249 million, so significantly below the outflow guidance that we set out at the start of this year. And then if you look at our third quarter quarterly cash -- operating cash outflow RMB47 million. That's even close to the run rates that we set for the year over 2024.

    你可以看到,今年迄今的三個季度,我們的資金流出約為人民幣2.49億元,大大低於我們年初設定的流出指引。然後,如果你看一下我們第三季的季度現金——經營現金流出 4700 萬元人民幣。這甚至接近我們為 2024 年設定的運行率。

  • So on that run rate, I'm looking at the cash balance at the end of this period of RMB637 million, and we're sitting on more than three years of cash runway. So we are in no rush to do anything. We're sitting on ample cash balance. And I just want to reiterate our strong cash position relative to our cash outflow on this page.

    因此,以這個運行率,我看到本期末的現金餘額為 6.37 億元人民幣,我們擁有超過三年的現金跑道。所以我們並不急於做任何事。我們擁有充足的現金餘額。我只想在此頁面重申我們相對於現金流出的強勁現金狀況。

  • And the reasons for the reduced cash outflow, I think we have mentioned that before. And I will just reiterate those here again. So first, our commercial operations is coming towards profitability. We were even slightly positive in the second quarter.

    至於現金流出減少的原因,我想我們之前已經提到過。我將在這裡再次重申這些內容。首先,我們的商業營運正在實現盈利。我們在第二季度甚至略有積極。

  • Our R&D spend, particularly our early cancer detection programs are maturing. And as these programs complete, the expenses associated with those programs will run off and that will help reduce cash spend naturally.

    我們的研發支出,特別是我們的早期癌症檢測計畫正在日趨成熟。隨著這些計劃的完成,與這些計劃相關的費用將會減少,這將有助於自然減少現金支出。

  • So as we look to complete our spend on early cancer detection and as we move towards better profitability, and then we'll look to improve our operating cash outflow that will make sure that we're sitting on ample cash balance.

    因此,當我們希望完成早期癌症檢測方面的支出並朝著更好的盈利能力邁進時,我們將尋求改善我們的營運現金流出,這將確保我們擁有充足的現金餘額。

  • Next, I'd like to turn to Joe, who has some importance pipeline and clinical publication data to share with you all.

    接下來,我想請 Joe,他有一些重要的管道和臨床發表數據可以與大家分享。

  • Joe Zhang - Director & CTO

    Joe Zhang - Director & CTO

  • Thanks, Leo. So I'm going to present a little bit and give you guys an introduction about the pipeline update, majorly focused on the MRD, which is minimal residual disease.

    謝謝,利奧。因此,我將向大家介紹一下管道更新,主要集中在 MRD,即最小殘留疾病。

  • So let's turn to Page 10. So Page 10, basically representing -- presenting the Burning Rock MRD clinical publication. So basically MRD has a lot of utilities as shown in the picture shown here.

    讓我們翻到第 10 頁。第 10 頁基本上代表了 Burning Rock MRD 臨床出版品。所以基本上 MRD 有很多實用程序,如下圖所示。

  • Basically, it can be done before the neo-adjuvant to look at the baseline of ctDNA level, that also we can do like after adjuvant therapy to look at treatment effectiveness or like more commonly going to be used at like a post-surgical after resection to look at landmark MRD to get a prognosis either some kind of a prediction value on the MRD status. And there also could be a lot of treatment effectiveness assessment after the adjuvant therapy and also the longitudinal monitoring for the surveillance.

    基本上,可以在新輔助治療之前檢查 ctDNA 水平的基線,我們也可以像輔助治療後那樣檢查治療效果,或更常見的是在切除術後進行查看具有里程碑意義的MRD 以獲得預後,或者對MRD狀態進行某種預測值。輔助治療後還可以進行大量的治療效果評估以及縱向監測監測。

  • So Burning Rock has a bunch of different kind of publication related to different cancer types, including non-small cell lung cancer as well as colorectal cancer, gastric cancer, pancreatic cancer, BTC, biliary tract cancer.

    因此,燃石醫學有大量與不同癌症類型相關的不同類型的出版物,包括非小細胞肺癌以及大腸癌、胃癌、胰腺癌、BTC、膽道癌。

  • So all the publication -- most of them actually showing in the poster format presented in different academic meeting or clinical meeting happened like within two years. So the major one, I just wanted to give you guys a little bit more introduction about the Cancer Cell publication, which related to the non-small cell lung cancer.

    所以所有的出版物——其中大多數實際上以海報形式展示在不同的學術會議或臨床會議上都發生在兩年之內。所以最重要的是,我只是想給大家多介紹一下《Cancer Cell》雜誌,它與非小細胞肺癌有關。

  • Let's turn to Page 11. So we as a technology, we've been using actually called brPROPHET, in brief it called PROPHET. So basically, it's based on a whole exome sequencing. We got a tumor whole exome sequencing data of up to 50 mutation, which is a tumor specific, then we designed a personalized panel, MRD panel and used this personalized penal trying to capture a potential ctDNA fragment from the plasm collected from the same patient.

    讓我們翻到第11頁。所以我們作為一種技術,我們一直在使用實際上稱為brPROPHET,簡單來說它稱為PROPHET。所以基本上,它是基於整個外顯子定序。我們獲得了多達50 個突變的腫瘤全外顯子組測序數據,這是腫瘤特異性的,然後我們設計了個性化面板,即MRD panel,並使用此個性化面板試圖從同一患者收集的血漿中捕獲潛在的ctDNA 片段。

  • And based on the proprietary ultra-deep sequencing and also (coughing) the proprietary sequencing result as well as MRD coding algorithm, then we can determine the MRD status of that patient for that kind of a -- that time point of blood collection.

    基於專有的超深度定序以及(咳嗽)專有的定序結果以及 MRD 編碼演算法,我們可以確定該患者在該採血時間點的 MRD 狀態。

  • So on the right page basically showing the analytical performance of this brPROPHET assay. So it's the including the two type of -- so on the top right panel basically I'm talking about a [contracted cell] samples diluted down to [8 PPM].

    右側頁面基本上顯示了 brPROPHET 檢測的分析效能。所以它包括兩種類型 - 所以在右上面板基本上我正在談論稀釋到 [8 PPM] 的 [收縮細胞] 樣品。

  • As you can see here -- you can see out of 50 low side, there's a quite a bit different -- significant difference compared to baseline, which is uncontracted, which is a background [cell]. So this give us some confidence showing this assay is sensitive enough to detect very low [allele] frequency -- very rare tumor fractions based on ctDNA from the patient.

    正如您在這裡所看到的,您可以看到,在 50 個低側中,與基線相比有相當大的不同,顯著差異是未收縮的,是背景[單元格]。因此,這給了我們一些信心,表明該檢測足夠靈敏,可以檢測頻率非常低的[等位基因]——基於患者 ctDNA 的非常罕見的腫瘤部分。

  • On the top right -- bottom right panel that's showing the quantitative property of this assay. Based on the algorithm we used, we can estimate based on the detection sensitivity -- detection capability as well as the allele frequency of each loci. We can assess, estimate, what's the ctDNA fraction from that patient.

    右上-右下面板顯示了此測定的定量特性。根據我們使用的演算法,我們可以根據檢測靈敏度——檢測能力以及每個位點的等位基因頻率來進行估計。我們可以評估、估計該患者的 ctDNA 分數。

  • As you can see here, this is a contract data, but it doesn't give us a lot of confidence showing the expectation and estimation showing very good correlation.

    正如您在此處所看到的,這是合約數據,但它並沒有給我們很大的信心,表明預期和估計顯示出非常好的相關性。

  • So based on this technology, we move to Page 12. Basically, we work with top-tier hospital in Beijing people, hospital and we published this technology utilization on the non-small cell lung cancer in Cancer Cell, which is a top journal -- top-tier journal for translational medicine.

    所以基於這個技術,我們轉到第12頁。基本上我們和北京的頂級醫院人民醫院合作,我們在頂級期刊《Cancer Cell》上發表了這個技術在非小細胞肺癌上的應用—— - 轉化醫學頂級期刊。

  • As you can see here -- so this is being published in October 9. And there are a couple of a highlight. I don't want to read it one by one, but you can look at it. Mostly it's just showing the PROPHET outperformed the fixed panel MRD assay in a head-to-head comparison in non-small cell lung cancer.

    正如您在此處所看到的,該文章將於 10 月 9 日發布。其中有幾個亮點。我不想一一看,但是你可以看一下。大多數情況下,它只是表明 PROPHET 在非小細胞肺癌的頭對頭比較中優於固定面板 MRD 測定。

  • Move to page 13. Basically, it give you a overview of this study. So the cohort is we enrolled about 181 patient, non-small cell lung cancer. But as you can see here, most of them are actually 63% of Stage I patients, very early-stage patients after surgery. And also there's a few of Stage II and Stage III.

    請移至第 13 頁。基本上,它為您提供了本研究的概述。我們招募了大約 181 名非小細胞肺癌患者。但正如你在這裡看到的,他們中的大多數實際上是 63% 的 I 期患者,即手術後非常早期的患者。還有一些第二階段和第三階段。

  • And the sampling time is that we basically collect the tumor that adjacent paired tissue normal, normal tissue collect at surgery and then we do the whole exome sequencing on those as well as like we collect a blood sample, collect the preoperative on the three days and 30 days after surgery.

    採樣時間是我們基本上收集鄰近配對的正常組織、手術時收集的正常組織的腫瘤,然後我們對它們進行全外顯子組測序,就像我們收集血液樣本一樣,收集術前三天的樣本,然後收集樣本。手術後30天。

  • And also we do a follow-up time. So every time one patient go back to see the doctor, after like six months or a year after, if possible, we collect the follow-up a blood sample. And then we use three different approach to look at MRD status.

    我們也會進行跟進時間。因此,每當一名患者回去看醫生時,如果可能的話,大約六個月或一年後,我們都會收集後續血液樣本。然後我們使用三種不同的方法來查看 MRD 狀態。

  • The first one is basically showing on the top right. It's a whole exome sequencing based personalized panel design as well as doing this MRD assay, we call brPROPHET assay. And comparison, we also using a fixed panel target sequencing to do the tumor -- either tumor agnostic or tumor informed (inaudible) to determine the MRD assays, but you can think about it this way. So basically whole exome sequencing gave us that many more potential mutation [result] compared to a relatively smaller fixed panel targeted sequencing.

    第一個基本上顯示在右上角。這是基於全外顯子定序的個人化面板設計以及 MRD 檢測,我們稱之為 brPROPHET 檢測。相較之下,我們也使用固定面板目標定序來進行腫瘤——無論是腫瘤不可知論還是腫瘤知情(聽不清楚)來確定 MRD 檢測,但您可以這樣想。因此,與相對較小的固定面板標靶定序相比,基本上全外顯子定序為我們提供了更多的潛在突變[結果]。

  • So by using this data, let's move to Page 14. Basically, there are several major conclusion, observation, we have seen. So the page 14 showing actually -- if you look at a pre-operative plasma sample, as you know, this sample is basically untreated patients coming from -- blood coming from untreated patient.

    因此,透過使用這些數據,讓我們轉到第 14 頁。基本上,我們已經看到了幾個主要的結論、觀察。因此,第 14 頁實際上顯示 - 如果您查看術前血漿樣本,如您所知,該樣本基本上是來自未經治療的患者 - 來自未經治療的患者的血液。

  • And that's why ideally if your assay is perfect, you should be able to see every patient blood will get like close to very high percentage of our detection sensitivity. As you can see here the sensitivity definitely grow up from Stage IA to Stage III. And at Stage III, you got higher sensitivity -- detection sensitivity, but as you can see here, the orange in color, which is representing the PROPHET assay.

    這就是為什麼理想情況下,如果您的檢測是完美的,您應該能夠看到每個患者的血液都將接近我們檢測靈敏度的非常高的百分比。正如您在這裡所看到的,從 IA 階段到 III 階段,敏感度肯定會提高。在第三階段,您獲得了更高的靈敏度——檢測靈敏度,但正如您在這裡看到的,橙色,代表 PROPHET 檢測。

  • So it outperformed the tumor-agnostic panel sequencing as well as tumor informed fixed panel sequencing. So totally basically at the Stage IIB, we already see 40% detectability and also Stage II, we see 75 patients with 83% positivity.

    因此,它優於腫瘤不可知的面板測序以及腫瘤知情的固定面板測序。所以基本上在 IIB 階段,我們已經看到了 40% 的可檢測性,在 II 階段,我們看到 75 名患者的陽性率為 83%。

  • And as you can see here, in the panel B showing on the right page. As you can see here, for all three MRD-positive patients sample, the ctDNA infraction showing the highest one, which is shown in the box plot with the red background. But if only the -- if you look at the orange color, which means on the right, there's a 30 patient -- pre-operative patient only showing a positive in brPROPHET assay.

    如您所看到的,在右側頁面上顯示的面板 B 中。正如您在此處所看到的,對於所有三名 MRD 陽性患者樣本,ctDNA 違規率最高,如紅色背景的箱線圖所示。但如果你看橙色,這意味著在右側,有 30 名患者術前患者僅在 brPROPHET 檢測中顯示出陽性。

  • But the ctDNA fractions is way lower, it's actually two magnitude lower than the all three positive patients. This is just a reflects the detection sensitivity in patients trying to get those very low allele frequency, very low tumor fraction patient trying to confirm the MRD status. Of course, this is a pre-operative.

    但 ctDNA 分數要低得多,實際上比所有三名陽性患者低兩個數量級。這只是反映了試圖獲得那些極低等位基因頻率、極低腫瘤分數的患者試圖確認MRD狀態的檢測靈敏度。當然,這是術前的準備。

  • So let's move to the Page 15. Basically, we use a post-operative blood sample to determine the real MRD status and also come associated with this kind of a status with the relapse potential to look at the disease-free survival.

    那麼讓我們轉到第 15 頁。基本上,我們使用術後血液樣本來確定真正的 MRD 狀態,並將這種狀態與復發潛力聯繫起來,以查看無病生存率。

  • On the left page, basically, as we are using the landmark time point, which is three days or -- which is time point B of 30 days after surgery, which is time point C to look at the survival curve. As you can see the DFS survival percentage, if you are MRD-negative, the patient, it will be showing that even for one-time point -- landmark time point to check and follow-up up to like 1,200 days.

    在左側頁面上,基本上,我們使用的是里程碑時間點,即三天,或手術後 30 天的時間點 B,這是查看生存曲線的時間點 C。正如您所看到的 DFS 生存百分比,如果您是 MRD 陰性的患者,即使是一次性檢查和隨訪長達 1,200 天的里程碑式時間點,也會顯示出這一點。

  • This show very way higher disease-free survival compared to MRD-positive patient, which is showing the HR ratio reached to basically for time points C, the HR other ratio reached to 16.4, which is a pretty significant difference.

    這表明與 MRD 陽性患者相比,無疾病存活率要高得多,這表明在時間點 C 的 HR 比率基本上達到 16.4,HR 其他比率達到 16.4,這是一個非常顯著的差異。

  • And on the right page -- right side of the panel, we're basically utilizing longitudinal MRD analysis. This is basically for multiple point time point assessment on the post-surgery patient plasma sample. And if there are any MRD-positive signal showing any time of the blood collection, we deem as MRD-positive.

    在右頁-面板的右側,我們基本上是利用縱向 MRD 分析。這基本上用於對術後患者血漿樣本進行多點時間點評估。如果在採血的任何時間有任何MRD陽性訊號顯示,我們就認為MRD陽性。

  • But if all the sample collected from patient is MRD-negative, then we deem it, MRD negative. As you can see here, the separation will be even better. That just give us a lot of a confidence also reflect a lot of other publications, continuous surveillance require multiple time point collection, usually gave us better separation of the disease-free survival. So basically, it's also non related to the Stage I or Stage II and III, basically showing very similar trend.

    但如果從患者身上採集的所有樣本都是MRD陰性,那麼我們就認為MRD陰性。正如您在這裡所看到的,分離效果會更好。這給了我們很大的信心,也反映了許多其他出版物,連續監測需要多個時間點收集,通常可以讓我們更好地分離無病生存。所以基本上,它也與第一階段或第二階段和第三階段無關,基本上表現出非常相似的趨勢。

  • So in summary, basically, this paper published in Cancer Cell gave us very good example showing how the personalized west bases MRD assay can give a very good prognosis value on the non-small cell lung cancer, even the stage I and also II and III.

    總而言之,發表在《Cancer Cell》上的這篇論文為我們提供了很好的例子,展示了個人化西鹼MRD 檢測如何為非小細胞肺癌(甚至是I 期、II 期和III 期)提供非常好的預後價值。 。

  • And so of course, we are still keep working on this assay and trying to working on multiple different kind of a cancer type and also trying to with other top-tier hospital, not only prognostic value. We also want to look at the predictive value and to see any kind of a clinical utility related to drug selection or any treatment effectiveness assessment.

    當然,我們仍在繼續研究這項檢測,並嘗試研究多種不同類型的癌症,並嘗試與其他頂級醫院合作,而不僅僅是預後價值。我們也希望研究預測價值,並了解與藥物選擇或任何治療效果評估相關的任何類型的臨床效用。

  • So that's concludes my part. Thank you. Back to the moderator.

    我的部分就到此結束。謝謝。回到主持人。

  • Operator

    Operator

  • Yes, thank you for participating in today's call. You may now disconnect. Everyone, have a great day.

    是的,感謝您參加今天的電話會議。您現在可以斷開連線。大家,祝你有美好的一天。

  • Yusheng Han - Founder, Chairman of the Board of Directors & CEO

    Yusheng Han - Founder, Chairman of the Board of Directors & CEO

  • Thank you.

    謝謝。

  • Leo Li - Director & CFO

    Leo Li - Director & CFO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • You are welcome.

    不客氣。