Biontech SE (BNTX) 2020 Q1 法說會逐字稿

Thank you for standing by and welcome to the BioNTech First Quarter 2020 Operational Progress and Financial Results Conference Call. (Operator Instructions) I must advise you the conference is being recorded today, Tuesday, the 12th of May 2020. I would now like to hand the call over to the Vice President, Investor Relations and Business Strategy, Sylke Maas. Please go ahead.

感謝您的耐心等待並歡迎參加 BioNTech 2020 年第一季營運進展和財務業績電話會議。 （操作員指示）我必須通知您，會議將於今天（2020 年 5 月 12 日星期二）進行錄製。我現在想將電話轉交給投資者關係和業務策略副總裁 Sylke Maas。請繼續。

Thank you for joining us today for BioNTech's First Quarter 2020 Update Call. Before we start, we encourage you to view the slides for this webcast as well as the financial results press release issued this morning, both of which are accessible on our website, in the Investors section.

感謝您今天參加 BioNTech 2020 年第一季更新電話會議。在我們開始之前，我們鼓勵您觀看本次網路廣播的幻燈片以及今天早上發布的財務業績新聞稿，這兩個內容都可以在我們網站的投資者部分存取。

As shown on Slide 2, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include but are not limited to the timing for enrollment and completion and reporting of data from our clinical trials and then potentially registration later of certain of our clinical trials and the impacts of the COVID pandemic on our business and our financial outlook.

如投影片 2 所示，在今天的簡報中，我們將做出幾項前瞻性陳述。這些前瞻性陳述包括但不限於我們臨床試驗的註冊、完成和數據報告的時間，以及我們某些臨床試驗稍後可能註冊的時間，以及新冠疫情對我們業務和財務前景的影響。

Actual results could differ from those we currently anticipate. You are therefore cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this conference call and webcast.

實際結果可能與我們目前的預期有所不同。因此，請注意不要過度依賴任何前瞻性陳述，這些陳述僅代表本次電話會議和網路廣播之日的情況。

Speaking and available for questions today will be Ugur Sahin, Chief Executive Officer; Özlem Türeci, Chief Medical Officer; and Sierk Poetting, Chief Financial and Operating Officer. Ryan Richardson, Chief Strategy Officer, is available for the Q&A session. I'll now hand the call over to Ugur Sahin, BioNTech's CEO.

今天將由首席執行官 Ugur Sahin 發言並回答問題； Özlem Türeci，首席醫療官；首席財務和營運長 Sierk Poetting。首席策略長 Ryan Richardson 出席了問答環節。現在我將把電話轉給 BioNTech 執行長 Ugur Sahin。

Thank you, Sylke. It's a pleasure to welcome you to our first 2020 conference call. I will start with a few introductory remarks about our quarterly and recent highlights. I will then provide an update on our COVID-19 program. Özlem Türeci will provide a brief pipeline update before handing the call over to Sierk Poetting, who will review our financial results and provide an update on our manufacturing-scale activities. I will then make a few closing remarks on the outlook for 2020 before opening up the call for your questions.

謝謝你，賽爾克。很高興歡迎您參加我們的 2020 年第一次電話會議。我將首先對我們的季度和近期亮點進行一些介紹性發言。然後我將提供有關我們的 COVID-19 計劃的最新資訊。 Özlem Türeci 將提供簡短的管道更新信息，然後將電話轉交給 Sierk Poetting，後者將審查我們的財務業績並提供有關我們製造規模活動的最新信息。然後，在開始提問之前，我將就 2020 年的前景做一些總結發言。

I wanted to start by quickly highlighting the significant progress we have made since the beginning of the year despite the ongoing COVID-19 pandemic. Slide 3 illustrates our vision of building a global, next-generation immunotherapy company. Our strategy is to utilize our suite of novel therapeutic platforms to fully exploit the potential of the immune system. We are advancing a pipeline of potentially first-in-class immunotherapies for the treatment of cancer and infectious diseases.

首先，我想快速強調一下，儘管新冠肺炎 (COVID-19) 疫情仍在持續，但我們自年初以來取得的重大進展。投影片 3 闡述了我們建立一家全球性下一代免疫治療公司的願景。我們的策略是利用我們的一套新型治療平台來充分發揮免疫系統的潛力。我們正在推進一系列潛在的一流免疫療法，用於治療癌症和傳染病。

The most recent coronavirus vaccine program, which we named Project Lightspeed, shows the speed and versatility of our mRNA vaccine technology. We have invested significantly in our manufacturing capabilities in the mRNA and cell therapy areas, which is a key pillar of our long-term strategy. I am incredibly proud that we have been able to quickly generate GMP-grade clinical drug supply for multiple vaccine candidates for our ongoing COVID-19 vaccine trials.

我們將最新的冠狀病毒疫苗計劃命名為 Project Lightspeed，展示了我們 mRNA 疫苗技術的速度和多功能性。我們在 mRNA 和細胞治療領域的製造能力上進行​​了大量投資，這是我們長期策略的關鍵支柱。我感到非常自豪的是，我們能夠為正在進行的 COVID-19 疫苗試驗的多種候選疫苗快速提供 GMP 級臨床藥物供應。

Finally, as we outlined in our last call, we quickly implemented a 3-point plan to manage the impact of the COVID-19 pandemic on our clinical programs. To date, that plan has been successful, and expectations for clinical trial time lines have not changed substantially since our last update.

最後，正如我們在上次電話會議中概述的那樣，我們迅速實施了一項三點計劃，以管理 COVID-19 大流行對我們臨床項目的影響。迄今為止，該計劃已經成功，自我們上次更新以來，對臨床試驗時間線的預期沒有發生實質變化。

This week, we achieved an important milestone with the close of the acquisition of Neon Therapeutics. Neon offices in Cambridge, Massachusetts will now serve as our U.S. headquarters and the hub for the U.S. research and development effort. This has provided an immediate R&D footprint in the U.S.

本週，我們完成了對 Neon Therapeutics 的收購，實現了一個重要的里程碑。位於麻薩諸塞州劍橋的 Neon 辦事處現在將作為我們的美國總部和美國研發工作的中心。這立即在美國提供了研發足跡。

As we have highlighted previously, the acquisition brings novel neoantigen-based T cell therapies and deep expertise in the development of neoantigen therapies, with both vaccine and as well as T cell capabilities. We are pleased to report that Neon recently received a clinical trial authorization from the Dutch health authority for NEO-PTC-01, which we have now named BNT221.

正如我們先前強調的，此次收購帶來了基於新抗原的新型 T 細胞療法和新抗原療法開發方面的深厚專業知識，包括疫苗和 T 細胞能力。我們很高興地報告，Neon 最近獲得了荷蘭衛生當局對 NEO-PTC-01 的臨床試驗授權，我們現在將其命名為 BNT221。

The drug candidate is a personalized neoantigen-targeted T cell therapy derived from patients' peripheral blood mononuclear cells, or PBMCs, consisting of multiple T cell populations targeting the most therapeutically relevant neoantigen from each patient's tumor. The initial Phase I clinical trial of BNT221 will be in patients with metastatic melanoma who are not responsive to checkpoint inhibitors. We will focus on the integration efforts in the coming months and look forward to providing additional detail in the coming quarters.

此候選藥物是一種源自患者周邊血單核細胞（PBMC）的個人化新抗原標靶T 細胞療法，由多個T 細胞群組成，針對每個患者腫瘤中與治療最相關的新抗原。 BNT221 的初步 I 期臨床試驗將針對對檢查點抑制劑沒有反應的轉移性黑色素瘤患者。我們將重點關注未來幾個月的整合工作，並期待在未來幾季提供更多細節。

Now let's move to Slide 4. I'm proud of our progress towards developing a vaccine to prevent COVID-19 infection to combat the pandemic tide. Since the beginning of the Project Lightspeed in late January, we have selected 4 vaccine candidates; and initiated clinical trials in the U.S. and in Europe, following a fast and rigorous preclinical testing program that included a number of studies in animal models as well as many, many in vitro assays. The first cohorts in both U.S. and Europe have now been dosed; and we expect first clinical data in late June and July time frame, assuming that our trial will progress as planned.

現在讓我們轉到幻燈片 4。我對我們​​在開發預防 COVID-19 感染的疫苗以對抗大流行浪潮方面取得的進展感到自豪。自1月下旬光速計畫啟動以來，我們已經選擇了4種候選疫苗；並在美國和歐洲啟動了臨床試驗，遵循快速而嚴格的臨床前測試計劃，其中包括大量動物模型研究以及許多體外測定。美國和歐洲的第一批患者現已接受注射；假設我們的試驗將按計劃進行，我們預計將在六月下旬和七月的時間範圍內獲得第一份臨床數據。

The clinical trial materials for these trials has been manufactured at our state-of-the-art GMP-certified mRNA manufacturing facilities in Europe. In parallel, we are working closely with Pfizer to scale up manufacturing for global supply capacity, at risk, to provide worldwide supplies. Our goal is to be in a position to produce hundreds of millions of doses in beginning 2021, along with Pfizer, if our vaccine program is successful in trials.

這些試驗的臨床試驗材料是在我們位於歐洲最先進的 GMP 認證的 mRNA 生產設施中生產的。同時，我們正在與輝瑞密切合作，擴大全球供應能力的生產規模，以提供全球供應。如果我們的疫苗計劃在試驗中取得成功，我們的目標是能夠在 2021 年初與輝瑞一起生產數億劑疫苗。

Slide 5. I want to provide a quick overview on the mRNA technologies being utilized for BNT162. On April 23, we hosted a webcast that provided a detailed overview of the science behind our program. A replay of that event is available on our website, in the Investor Relations section, for those that missed it and would like to know additional details.

投影片 5。我想快速概述 BNT162 使用的 mRNA 技術。 4 月 23 日，我們舉辦了一次網路廣播，詳細概述了我們計畫背後的科學原理。對於那些錯過了活動並想了解更多詳細資訊的人，可以在我們網站的投資者關係部分重播活動。

Our mRNA vaccine for COVID-19 exploits a highly potent lipid nanoparticle or LNP mRNA vaccine product. We believe that mRNA vaccines are highly suited for this challenge because, first, mRNA vaccines have been shown to be highly immunogenic and induce neutralizing antibodies as well as T cell response. Second, messenger RNA is a naturally occurring molecule with well-characterized safety properties as well as defined biopharmaceuticals with a high purity and are animal free.

我們的 COVID-19 mRNA 疫苗採用高效能脂質奈米顆粒或 LNP mRNA 疫苗產品。我們相信 mRNA 疫苗非常適合應對這項挑戰，因為首先，mRNA 疫苗已被證明具有高度免疫原性並誘導中和抗體以及 T 細胞反應。其次，信使RNA是一種天然存在的分子，具有良好的安全特性，也是高純度且不含動物成分的明確生物藥物。

We believe that our vaccines may offer several advantage over traditional vaccine approaches, including the ability to precisely design and manufacture them rapidly and in large quality.

我們相信，與傳統疫苗方法相比，我們的疫苗可能具有多種優勢，包括能夠快速、高品質地精確設計和製造疫苗。

We believe that our vaccine program is differentiated in a number of key aspects. The first is that our program utilizes multiple mRNA formats. 2 of our 4 vaccine candidates include a nucleoside-modified mRNA backbone, 1 includes a uridine-containing messenger RNA, and the fourth vaccine candidate utilizes a self-amplifying mRNA.

我們相信，我們的疫苗計劃在許多關鍵方面都與眾不同。首先，我們的程式利用多種 mRNA 格式。在我們的 4 種候選疫苗中，有 2 種包含核苷修飾的 mRNA 主鏈，1 種包含含尿苷的信使 RNA，第四種候選疫苗利用自我擴增 mRNA。

We expect that -- these different mRNA formats to produce different immunogenicity profiles, which could be relevant in determining the dose and dosing frequency ultimately required to generate immunity. Self-amplifying messenger RNA in particular has the advantage that it may allow for greater potency and potentially enable a single administration at a very low dose.

我們預計，這些不同的 mRNA 格式會產生不同的免疫原性特徵，這可能與確定產生免疫力最終所需的劑量和給藥頻率有關。自擴增信使RNA尤其具有以下優點：它可以實現更大的效力，並且有可能以非常低的劑量進行單次給藥。

Further, our program is differentiated in that we are bringing vaccines against 2 distinct targets into clinical testing. One is the full-length type protein of the virus, and the other is the much smaller optimized receptor-binding domain or RBD from the spike protein. To our knowledge, we are the only company currently in clinical testing with a vaccine targeting the RBD domain. Ultimately, we will need to wait for clinical data before we can draw some conclusions whether this domain has advantage, as compared to full-length antigen.

此外，我們的計劃的與眾不同之處在於，我們正在將針對兩個不同目標的疫苗納入臨床測試。一種是病毒的全長型蛋白​​，另一種是來自刺突蛋白的小得多的最佳化受體結合域或 RBD。據我們所知，我們是目前唯一一家針對 RBD 領域的疫苗進行臨床測試的公司。最終，我們需要等待臨床數據，然後才能得出該結構域與全長抗原相比是否具有優勢的結論。

I will now turn to Slide 6. I will provide an update on our ongoing global development program for BNT162. As stated before, we have completed dosing for the first cohorts in both our U.S. as well as in our European Phase I/II trials.

我現在將轉向幻燈片 6。我將提供有關我們正在進行的 BNT162 全球開發計劃的最新資訊。如前所述，我們已經在美國和歐洲 I/II 期試驗中完成了第一批患者的給藥。

In both cases, BioNTech is the sponsor of these trials. The dose escalation portion of Phase I/II trials will include about 200 healthy subjects in Europe as well as 360 healthy subjects in the U.S. In both trials, the objective is to determine the safety, immunogenicity and the optimal dose level for our 4 messenger RNA vaccine candidates; and is evaluated in a single continuous study.

在這兩種情況下，BioNTech 都是這些試驗的贊助商。 I/II 期試驗的劑量遞增部分將包括約200 名歐洲健康受試者以及360 名美國健康受試者。在這兩項試驗中，目的是確定我們的4 種信使RNA 的安全性、免疫原性和最佳劑量水平候選疫苗；並在單一連續研究中進行評估。

The design of the U.S. study has the advantage that it could allow us to move seamlessly into Phase II testing if the Phase I results are successful and allow us immunization of several thousands of subjects. Both trials are currently enrolling healthy subjects between the ages of 18 to 55 and will target a dose range of at least 1 microgram to 100 microgram.

美國研究的設計的優點是，如果第一階段的結果成功，我們可以無縫地進入第二階段的測試，並允許我們對數千名受試者進行免疫。這兩項試驗目前正在招募年齡在 18 至 55 歲之間的健康受試者，目標劑量範圍至少為 1 微克至 100 微克。

The study will assess the effects of repeated vaccination following a prime injection for the 3 vaccine candidates that utilize uridine-containing messenger RNA or nucleoside-modified mRNA. The fourth vaccine candidate, which contains self-amplifying mRNA, will be evaluated after a single dose as well as a prime-boost vaccine. All the adults will only be immunized with a given dose level of a vaccine candidate once a testing of that candidate and the dose level in younger adults has provided initial evidence of safety and immunogenicity.

研究將評估 3 種利用含尿苷信使 RNA 或核苷修飾 mRNA 的候選疫苗初次注射後重複接種疫苗的效果。第四種候選疫苗含有自我擴增 mRNA，將在單劑和初免疫苗後進行評估。只有在候選疫苗和年輕人劑量水平的測試提供了安全性和免疫原性的初步證據後，所有成年人才會使用給定劑量水平的候選疫苗進行免疫。

We have a number of key objectives with our trial design. First, it is designed to accelerate the clinical development path to approval. Another objective is to get insights into the immunogenicity of our vaccine candidates in different subject groups across multiple regions. The ultimate goal is to quickly identify a safe vaccine candidate that can prevent COVID-19.

我們的試驗設計有許多關鍵目標。首先，它旨在加速臨床開發路徑的批准。另一個目標是深入了解我們的候選疫苗在多個地區不同受試者群體中的免疫原性。最終目標是快速確定一種可以預防 COVID-19 的安全候選疫苗。

I will now hand over to Özlem to discuss key updates in our development program.

我現在將交給 Özlem 討論我們開發計劃的關鍵更新。

Thank you, Ugur. Today, I'm going to provide key updates for our oncology pipeline since our last call. In our call at the end of March, we have indicated those programs for which we expect delays due to the pandemic. There have been no major changes to our trial time lines since our last call.

謝謝你，烏古爾。今天，我將提供自上次電話會議以來我們的腫瘤學管道的重要更新。在三月底的電話會議中，我們指出了預計因疫情而推遲的項目。自上次通話以來，我們的試用時間沒有重大變化。

As the COVID-19 pandemic remains dynamic, we will continue to monitor the situation as it evolves and provide further updates accordingly. As Ugur previously mentioned, we made progress in our oncology clinical trials, and I'll lead you through key updates to our clinical pipeline, as shown on Slide 7.

由於 COVID-19 大流行仍然處於動態狀態，我們將繼續監測事態的發展並相應地提供進一步的更新。正如 Ugur 之前提到的，我們在腫瘤學臨床試驗中取得了進展，我將引導您完成我們臨床管道的關鍵更新，如幻燈片 7 所示。

We have 11 product candidates and 12 ongoing clinical trials. We are planning to initiate 2 randomized Phase II trials for our FixVac candidates BNT111 and BNT113 in melanoma and in head, neck cancer, respectively. For BNT111, our melanoma FixVac, we expect the next program update to be publication of our interim Phase I trial data in advanced melanoma in a high-ranked peer-reviewed journal in the next few months.

我們有 11 個候選產品和 12 個正在進行的臨床試驗。我們計劃針對 FixVac 候選藥物 BNT111 和 BNT113 分別針對黑色素瘤和頭頸癌啟動 2 項隨機 II 期試驗。對於我們的黑色素瘤 FixVac BNT111，我們預計下一個計劃更新將是在未來幾個月內在高級同行評審期刊上發布我們針對晚期黑色素瘤的臨時 I 期試驗數據。

As we previously noted, we have held discussions with regulatory authorities regarding next steps and the design of the Phase II trial. Based on those discussions, we believe there may be potential for it to be registrational. We expect to evaluate BNT111 in combination with a checkpoint inhibitor in patients who are checkpoint inhibitor experienced at baseline. We plan to provide a further update on the expected trial design in the third quarter of 2020.

正如我們之前指出的，我們已與監管機構就後續步驟和二期試驗的設計進行了討論。根據這些討論，我們認為它可能有註冊的潛力。我們期望在基線時經歷過檢查點抑制劑的患者中評估 BNT111 與檢查點抑制劑的合併使用。我們計劃在 2020 年第三季提供預期試驗設計的進一步更新。

Moving on to our iNeST program, to BNT122, which is partnered with Genentech. On our last call, we indicated that a data update for the Phase I/II trial in multiple solid tumors was planned at the AACR annual meeting, which due to the COVID pandemic was rescheduled for August 2020 at that time.

繼續我們的 iNeST 計劃，即與 Genentech 合作的 BNT122。在我們上次的電話會議上，我們表示計劃在 AACR 年會上更新多種實體瘤的 I/II 期試驗的數據，但由於新冠病毒大流行，會議被重新安排在 2020 年 8 月。

Since the AACR meeting has gone virtual, we now plan to present the data at the AACR Virtual Annual Meeting II in June. We expect abstracts to be available on May 15. The data to be presented in June will include safety and immunogenicity data in multiple solid tumor types.

由於 AACR 會議已改為虛擬會議，我們現在計劃在 6 月舉行的 AACR 虛擬年會 II 上展示數據。我們預計摘要將於 5 月 15 日提供。6 月提供的數據將包括多種實體瘤類型的安全性和免疫原性數據。

For BNT122, 2 additional randomized Phase II clinical trials in the adjuvant setting are planned. The first adjuvant Phase II study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of BNT122 plus atezolizumab compared with atezolizumab alone in patients with stage 2 to 3 non-small cell lung cancer who are positive for circulating tumor DNA following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy.

對於 BNT122，計劃進行另外 2 項輔助治療隨機 II 期臨床試驗。第一項輔助II 期研究將評估BNT122 合併atezolizumab 與單用atezolizumab 相比，在手術切除後循環腫瘤DNA 呈陽性的2 至3 期非小細胞肺癌患者中的療效、安全性、藥物動力學、免疫原性和生物標記。已接受標準護理輔助鉑類雙藥化療。

For our next-generation checkpoint-immune modulatory program partnered with Genmab, the ongoing trial with BNT311, the PD-L1x4-1BB dual body, continues to advance rapidly, as the expansion cohort has been initiated. Data from this Phase I/II trial in multiple solid tumors is expected in the second half of this year. We expect the updates to include dose escalation and safety data from the trial.

對於我們與 Genmab 合作的下一代檢查點免疫調節項目，隨著擴展隊列的啟動，正在進行的 BNT311（PD-L1x4-1BB 雙體）試驗繼續快速推進。這項針對多種實體瘤的 I/II 期試驗的數據預計將於今年下半年獲得。我們預計更新將包括試驗的劑量遞增和安全數據。

We are excited about this program. We believe it has broad potential in a range of solid tumors, including those where checkpoint therapy is currently established but also in more difficult tumors where first-generation checkpoint inhibitors have not been as successful.

我們對這個計劃感到很興奮。我們相信它在一系列實體瘤中具有廣泛的潛力，包括目前已建立檢查點療法的實體腫瘤，以及第一代檢查點抑制劑尚未成功的更困難的腫瘤。

This bispecific antibody has outperformed conventional checkpoint inhibitors in preclinical animal models. We have seen strong evidence in the preclinical setting of its ability to amplify the effect of our vaccines as well.

這種雙特異性抗體在臨床前動物模型的表現優於傳統的檢查點抑制劑。我們在臨床前環境中看到了強而有力的證據，證明它也有能力放大我們疫苗的效果。

Finally, BNT211, our CAR-T program targeting solid tumors, remains on track to go in the clinic this summer. This program combines our CAR-T therapeutic approach with our mRNA vaccination and uses our proprietary tumor-selective target Claudin 6.

最後，我們針對實體瘤的 CAR-T 計畫 BNT211 仍有望在今年夏天進入臨床。該計畫將我們的 CAR-T 治療方法與 mRNA 疫苗接種相結合，並使用我們專有的腫瘤選擇性標靶 Claudin 6。

I will now hand the call over to Sierk to provide an update on our manufacturing scale-up activities and discuss our current financial results for the first quarter of 2020.

我現在將把電話轉交給 Sierk，提供我們製造規模擴大活動的最新信息，並討論我們 2020 年第一季度的當前財務業績。

Thank you, Özlem. Before presenting the financial results, I would like to reiterate the measures that we put in place in order to mitigate the potential impact of the coronavirus pandemic on our operations, as we noted on our last call. We've put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. We have not seen any impact on our mRNA manufacturing, nor on our key manufacturing operations. BioNTech will continue to evaluate potential effects and provide updates as appropriate.

謝謝你，厄茲萊姆。在公佈財務業績之前，我想重申我們為減輕冠狀病毒大流行對我們營運的潛在影響而採取的措施，正如我們在上次電話會議中指出的那樣。我們已採取重大措施來保護供應鏈、營運、員工和臨床試驗的執行。我們沒有看到對我們的 mRNA 製造以及我們的關鍵製造業務有任何影響。 BioNTech 將繼續評估潛在影響並視情況提供更新。

Turning to Slide 8. We are currently manufacturing clinical trial material for the ongoing vaccine trials in the U.S. and Europe from our GMP facility in Idar-Oberstein, Germany and will soon be manufacturing in our Mainz, Germany facility as well.

轉向幻燈片 8。我們目前正在德國伊達爾-奧伯施泰因的 GMP 工廠生產用於美國和歐洲正在進行的疫苗試驗的臨床試驗材料，很快也將在德國美因茨的工廠生產。

We started GMP manufacturing of mRNA in Idar-Oberstein and Mainz in 2011 and 2017, respectively, so these teams have substantial experience in doing so. We have already established 24/7 operations in Mainz, so we aim to start producing clinical trial materials soon around the clock for use in our global development program.

我們分別於 2011 年和 2017 年開始在伊達爾-奧伯施泰因和美因茨進行 mRNA 的 GMP 生產，因此這些團隊在這方面擁有豐富的經驗。我們已經在美因茨建立了 24/7 營運模式，因此我們的目標是盡快開始全天候生產臨床試驗材料，用於我們的全球開發計劃。

We are also working closely with Pfizer to ramp up our manufacturing capacity for global commercial supply. On the BioNTech side, this will involve increasing capacity at our current sites in Germany. Pfizer will also utilize 3 of their existing manufacturing sites in the U.S., in Massachusetts, Michigan and Missouri; and also at a site in Europe.

我們也與輝瑞密切合作，提高我們的全球商業供應的製造能力。在 BioNTech 方面，這將涉及增加我們目前在德國的工廠的產能。輝瑞也將利用其在美國麻薩諸塞州、密西根州和密蘇裡州的 3 個現有生產基地；以及歐洲的一個地點。

BioNTech and Pfizer have established joint teams to work on process and supply chain scale-up and network planning. Ultimately, our joint goal is to be in a position to supply millions of doses of our vaccine in 2020 and hundreds of millions of doses in 2021.

BioNTech 和輝瑞建立了聯合團隊，致力於製程和供應鏈規模擴大以及網路規劃。最終，我們的共同目標是能夠在 2020 年供應數百萬劑疫苗，並在 2021 年供應數億劑疫苗。

Now I would like to summarize our financial results that are shown on Slide 9. Cash and cash equivalents as of March 31, 2020, were EUR 452 million. Additional EUR 217 million in equity investments and non-dilutive upfront payments are due in the second quarter of 2020 from Pfizer and Fosun Pharma.

現在我想總結一下投影片 9 中顯示的我們的財務表現。截至 2020 年 3 月 31 日，現金和現金等價物為 4.52 億歐元。輝瑞和復星醫藥將於 2020 年第二季額外支付 2.17 億歐元的股權投資和非稀釋性預付款。

We are on track with our previous guidance of approximately EUR 300 million net cash to be used for operating activities and investments into property, plant and equipment as defined in our 2020 base business plan prior to reflecting the impact of the Neon acquisition and our BNT162 program. The majority of BioNTech development costs for our BNT162 program in 2020 will be funded by Pfizer and Fosun Pharma via cost sharing, equity investments and upfront payments. We also anticipate additional funding to support our manufacturing scale-up for the BNT162 program in 2020.

在反映 Neon 收購和 BNT162 計劃的影響之前，我們正按照我們 2020 年基本業務計劃中定義的約 3 億歐元淨現金用於營運活動和投資房地產、廠房和設備的先前指導進行進展。 2020 年 BNT162 專案的大部分 BioNTech 開發成本將由輝瑞和復星醫藥透過成本分攤、股權投資和預付款的方式提供。我們也預計將在 2020 年獲得額外資金來支持 BNT162 計畫的生產規模擴大。

Total revenue, consisting primarily of revenue from collaborative agreements, was EUR 27.7 million for the 3 months ended March 31, 2020, compared to EUR 26.2 million for the 3 months ended March 31, 2019. The increase was mainly due to revenues resulting from other sales transactions, i.e., development and manufacturing services sold to third-party customers, retroviral vectors for clinical supply and sales of peptides.

截至2020年3月31日止三個月的總收入（主要包括合作協議收入）為2,770萬歐元，而截至2019年3月31日止三個月為2,620萬歐元。這一增長主要是由於其他業務產生的收入銷售交易，即出售給第三方客戶的開發和製造服務、用於臨床供應的逆轉錄病毒載體和勝肽的銷售。

Research and development expenses were EUR 65.1 million for the 3 months ended March 31, 2020, compared to EUR 57.2 million for the 3 months ended March 31, 2019. The increase was primarily due to an increase in head count leading to higher wages, benefits and social security expenses; as well as an increase in expenses for purchased research services.

截至2020年3月31日止三個月的研發費用為6,510萬歐元，而截至2019年3月31日止三個月的研發費用為5,720萬歐元。這一增長主要是由於員工人數增加導致工資、福利增加和社會保障費用；以及購買研究服務的費用增加。

General and administrative expenses were EUR 15.8 million for the 3 months ended March 31, 2020, compared to EUR 9.3 million for the 3 months ended March 31, 2019. This increase was mainly driven by higher legal expenses; an increase in head count leading to higher wages, benefits and social security expenses; as well as higher expenses due to newly concluded insurance premiums.

截至2020年3月31日止三個月的一般及行政費用為1,580萬歐元，而截至2019年3月31日止三個月的一般及行政費用為930萬歐元。這一增長主要是由於法律費用增加；員工人數增加導致薪資、福利和社會安全費用增加；以及因新簽訂的保險費而增加的費用。

Net loss was EUR 53.4 million for the 3 months ended March 31, 2020, compared to a net loss of EUR 40.8 million for the 3 months ended March 31, 2019. Shares outstanding as of March 31, 2020, were approximately 226.8 million. With that, I will return the call back to Ugur for concluding remarks.

截至2020年3月31日止三個月的淨虧損為5,340萬歐元，而截至2019年3月31日止三個月的淨虧損為4,080萬歐元。截至2020年3月31日已發行股數約2.268億股。至此，我將回電給 Ugur 進行總結發言。

Thank you, Sierk. The first quarter of 2020 has brought extraordinary challenges, and I am extremely proud of how we have -- as an organization have responded to these challenges. With the addition of BioNTech U.S. last week, we now have operations on both sides of the Atlantic. We have rapidly advanced our COVID-19 program and started dosing patients in Europe and in the U.S. We look forward to having data in the coming months from these trials.

謝謝你，西爾克。 2020 年第一季帶來了非凡的挑戰，我對我們作為一個組織如何應對這些挑戰感到非常自豪。隨著上週 BioNTech U.S. 的加入，我們現在在大西洋兩岸都有業務。我們已經迅速推進了我們的 COVID-19 計劃，並開始在歐洲和美國給患者用藥。我們期待在未來幾個月內獲得這些試驗的數據。

There's 11 product candidates now in the clinic. We have made significant progress towards our vision of bringing next-generation immunotherapies to patients. In the second half of 2020, we plan to release additional clinical data for 6 clinical programs. And we plan to initiate multiple registrational trails pending regulatory approval.

診所目前有 11 種候選產品。我們在為患者提供下一代免疫療法的願景方面取得了重大進展。 2020年下半年，我們計畫發布6個臨床計畫的額外臨床數據。我們計劃啟動多項註冊試驗，等待監管部門的批准。

We look forward to updating investors and other stakeholders throughout 2020. We thank our shareholders for their trust and support. We will now take any questions you may have. Operator?

我們期待在 2020 年向投資者和其他利害關係人通報最新情況。我們感謝股東的信任和支持。我們現在將回答您可能提出的任何問題。操作員？

(Operator Instructions) Your first question comes from the line of Akash Tewari of Wolfe Research.

（操作員說明）您的第一個問題來自 Wolfe Research 的 Akash Tewari。

So this is in regards to your update on BNT121. I think this was at ASCO earlier this year. We noticed one patient, I think it was patient 7. He got -- he or she got a CR and died around month 24 after treatment. And so this was a 121-pembro combo. Can you give any additional color on the death of that patient? Have you dived into that patient's immune response or tumor mutation profile in order to understand the disease progression?

這是關於您對 BNT121 的更新。我想這是今年早些時候在 ASCO 舉行的。我們注意到一名患者，我認為是 7 號患者。他或她獲得了 CR，並在治療後 24 個月左右死亡。這是一個 121-pembro 組合。您能否對那位患者的死亡提供更多資訊？您是否深入研究了該患者的免疫反應或腫瘤突變譜以了解疾病進展？

Next question is I noticed on your self-amplifying formulation you're choosing the full-length S protein as your antigen. Any color on why you chose the full-length S protein versus the receptor-binding domain? And on your BNT122 trial for NSCLC, we noticed that you went into an adjuvant setting before the basket trials kind of read out. What type of signals were you seeing that allowed you to expand in that indication?

下一個問題是我注意到在您的自放大配方中您選擇全長 S 蛋白作為抗原。有什麼顏色可以解釋為什麼您選擇全長 S 蛋白而不是受體結合域嗎？在你們針對 NSCLC 的 BNT122 試驗中，我們注意到你們在籃子試驗讀出之前就進入了輔助治療環境。您看到什麼類型的訊號可以讓您在該指標上擴展？

Okay. So let's start with the question that -- the saRNA-related question. So we evaluated for each platform different immunogens, including the receptor-binding domain as well as the full-length stabilized spike protein. And for the saRNA, the full-length spike protein was significantly better.

好的。讓我們從與 saRNA 相關的問題開始。因此，我們評估了每個平台的不同免疫原，包括受體結合域以及全長穩定刺突蛋白。對於 saRNA，全長刺突蛋白明顯較好。

So just to remind you, the saRNA comes with -- not only with some antibody response but also with a mixed T cell response, including CD4 and CD8 T cells. And the spike protein itself has multiple epitopes and more epitopes for T cell generation than the RBD domain.

提醒您一下，saRNA 不僅帶有一些抗體反應，還帶有混合 T 細胞反應，包括 CD4 和 CD8 T 細胞。而且刺突蛋白本身俱有多個表位，並且比 RBD 結構域有更多的用於 T 細胞生成的表位。

So in a nutshell, a benchmarking of the RBD and the spike domain for the self-amplifying mRNA, we [found] that the full-length spike is the better immunogen for the saRNA. The -- with regard to 122, can you repeat your question? 122 is iNeST. And we didn't get the background of your question.

簡而言之，透過對自擴增 mRNA 的 RBD 和刺突域進行基準測試，我們[發現]全長刺突是 saRNA 更好的免疫原。關於122，您能重複您的問題嗎？ 122 是 iNeST。我們不了解你問題的背景。

Yes. My apologies. Just we noticed that you announced an adjuvant trial in NSCLC. And I think you haven't released the data from your basket study. So we were just wondering, what type of signals did you see in your early clinical data that made you confident that you wanted to explore that setting?

是的。我很抱歉。我們剛剛注意到您宣布了一項針對非小細胞肺癌的輔助試驗。我認為你還沒有公佈你的籃子研究的數據。所以我們只是想知道，您在早期臨床數據中看到了哪些類型的訊號，使您確信自己想要探索該環境？

Yes. So the abstracts for our -- from our clinical trials will come out in a few days. What I can share is an observation which we had already published in the -- for our melanoma trials showing that patients that -- with in -- with melanoma, even with a post-metastatic melanoma, could be controlled with vaccine and lack of relapses after application of iNeST.

是的。因此，我們的臨床試驗摘要將在幾天內公佈。我可以分享的是我們已經在黑色素瘤試驗中發表的一項觀察結果，表明患有黑色素瘤的患者，即使是轉移後的黑色素瘤，也可以通過疫苗得到控制，並且不會復發。在應用iNeST 後。

And we have now several indications from -- also from the FixVac trial that patients with a lower tumor mass could be ideally suited for this type of vaccine and vaccine-checkpoint combination trials. And the ctDNA positive population in lung cancer is a population which has occult metastatic disease.

現在，我們從 FixVac 試驗中得到了一些跡象，即腫瘤品質較低的患者可能非常適合此類疫苗和疫苗檢查點組合試驗。而肺癌ctDNA陽性族群是有隱性轉移性疾病的族群。

Metastatic disease is, by definition, relatively low tumor load. And we believe that this patient, therefore, will particularly benefit with regard to their disease-free survival or -- and metastasis-free survival rates. That's the rationale behind that. And it's not the only study in this setting. We will announce a second indication which will come with the same rationale.

根據定義，轉移性疾病是相對較低的腫瘤負荷。因此，我們相信該患者的無疾病存活率或無轉移存活率將特別受益。這就是背後的原理。這並不是這一背景下的唯一研究。我們將宣布第二個跡象，其理由相同。

The next question comes from the line of Cory Kasimov of JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

This is Matthew on for Cory. So my first question is on BNT126 -- or 162. For the initial Phase I data in June or July, how many patients should we expect to see? And should we be thinking about this as both a safety and immunogenicity update?

這是科里的馬修。所以我的第一個問題是關於 BNT126 或 162。對於 6 月或 7 月的初始 I 期數據，我們預計會看到多少患者？我們是否應該將其視為安全性和免疫原性更新？

Yes. Yes, it's both. So we started the trial in April 21 in Germany and about 2 weeks later in the U.S. Both trials are recruiting now first subjects, and the number of subjects is accumulating. You know that the German study is going to recruit about 200 subjects. The U.S. study in the first initial stage is expected to recruit about 360 subjects.

是的。是的，兩者都是。因此，我們在 4 月 21 日在德國開始了試驗，大約兩週後在美國開始了試驗。這兩項試驗現在都在招募第一批受試者，受試者數量正在增加。你知道德國的研究將招募大約200名受試者。美國的研究第一階段預計招募約360名受試者。

End of June, we will have data available of about 50, 60, 70 subjects; and this will dynamically increase. And we will, of course, have data on the dose-dependent safety profile as well as dose-dependent immunogenicity profile.

6月底，我們將獲得約50、60、70名受試者的數據；並且這會動態增加。當然，我們將擁有有關劑量依賴性安全性和劑量依賴性免疫原性的數據。

Great. That's super helpful. And then, I guess, in regard to the Phase II program, based on the comments in your prepared remarks, I'm curious if we should expect this Phase II trial can start sometime in 2020 and that the trial size will be north of 1,000 patients.

偉大的。這非常有幫助。然後，我想，關於第二階段計劃，根據您準備好的評論中的評論，我很好奇我們是否應該期望第二階段試驗可以在 2020 年的某個時候開始，並且試驗規模將超過 1,000患者。

Yes. So the trial, as it is indicated in the clinical trials -- on the Clinical Trials website, can -- it's designed in a manner that it can seamless go from Phase I/II to Phase III, yes. And this would also cover like recruitment of up to several thousand subjects, but it will depend on regulatory approvals to -- so yes, end point.

是的。因此，正如臨床試驗網站上的臨床試驗所示，該試驗的設計方式可以從 I/II 期無縫過渡到 III 期，是的。這也將涵蓋招募多達數千名受試者，但這將取決於監管部門的批准——所以是的，終點。

The next question comes from Daina Graybosch of Leerink.

下一個問題來自 Leerink 的 Daina Graybosch。

Two for me, both on BNT162. The first is on manufacturing. And I think you've spoken a lot about the mRNA manufacturing. I'd love to understand the limitation of lipid nanoparticle formulation and fill and finish in the scale-up and whether that depends on which of the mRNA technology platforms [you use].

我有兩個，都在 BNT162 上。首先是製造業。我認為您已經談了很多有關 mRNA 製造的內容。我很想了解脂質奈米顆粒配方的局限性以及放大過程中的填充和完成，以及這是否取決於[您使用的] mRNA 技術平台。

And the second question is on the clinical strategy. I wonder -- and you started to talk about this just previously. I wonder if you could help us understand the seamless design; if you can talk to any predefined thresholds to move from Phase I to II to III; and whether there's any plan to do some of the Phase III in parallel to Phase II.

第二個問題是關於臨床策略。我想知道——你之前就開始談論這個問題了。我想知道你能否幫助我們理解無縫設計；您是否可以與任何預先定義的閾值交談以從第一階段進入第二階段再進入第三階段；以及是否有計劃將第三階段的一些工作與第二階段並行。

Daina, so to the first part of your question. So you are aware that we are using 4 different RNA backbones -- or 3 different RNA backbones and have 4 candidates, and all 4 candidates have the same lipid nanoparticle technology and exactly the same formulation. So that means the upscaling of 1 candidate, the [MMP] formulation for 1 candidate would be -- would also serve for the upscaling of the other candidates.

戴娜，現在回答你問題的第一部分。所以你知道我們正在使用4 種不同的RNA 主鏈，或者3 種不同的RNA 主鏈，並且有4 個候選物，並且所有4 個候選物都具有相同的脂質奈米顆粒技術和完全相同的配方。因此，這意味著 1 名候選人的升級，1 名候選人的 [MMP] 表述將是 - 也將用於其他候選人的升級。

We expect that the nucleoside-modified mRNA and the dose for the nucleoside-modified mRNA will be in the range between 10 to 100 microgram, yes. So that is more the higher end of dosing. And we expect that the dose of a potential active vaccine for uridine and self-amplifying RNA will be in the single-digit or even lower than single-digit concentration.

我們預期核苷修飾的 mRNA 和核苷修飾的 mRNA 的劑量將在 10 至 100 微克之間，是的。所以這就是劑量的上限。我們預計，針對尿苷和自擴增RNA的潛在活性疫苗的劑量將在個位數甚至低於個位數濃度。

So that means the challenge for upscaling for manufacturing for the different mRNA platforms are different scales. So for the nucleoside-modified mRNA to scale, the manufacturing scale will be higher. And we are prepared, together with our partner Pfizer, to be able to scale up to supply nucleoside-modified mRNA.

因此，這意味著不同 mRNA 平台的生產升級所面臨的挑戰是不同的。所以核苷修飾的mRNA要規模化，生產規模會更大。我們準備與我們的合作夥伴輝瑞一起擴大規模以供應核苷修飾的 mRNA。

And currently we are addressing everything what is required, including the supply chain to -- for manufacturing including nucleotides, lipids, enzymes and so on, to be able to deliver the scale that we have announced recently, yes. And this -- if this scale is -- can be produced for nucleoside-modified mRNA across the same scale, will provide many more vaccine units, yes, for the self-amplifying or uridine mRNA. So that's the overall strategy.

目前，我們正在解決所需的一切問題，包括核苷酸、脂質、酵素等製造所需的供應鏈，以便能夠實現我們最近宣布的規模，是的。如果這個規模是這樣的話，可以以相同的規模生產核苷修飾的 mRNA，將為自擴增或尿苷 mRNA 提供更多的疫苗單位。這就是總體策略。

The strategy for the clinical trial is -- will be published in a few weeks. The overall strategy is to enable a clinical development plan which can give us at a certain time point full approval but might also be compatible with an earlier end point, yes. And as you know, there are no official statements, so far, from regulatory authorities, from EMA or FDA which kind of end point would be accepted, and therefore everything -- what we can share at the moment would be speculation.

臨床試驗的策略是—將在幾週內發布。整體策略是製定臨床開發計劃，該計劃可以在某個時間點給予我們完全批准，但也可能與更早的終點相容，是的。如您所知，到目前為止，監管機構、EMA 或 FDA 還沒有官方聲明哪種終點會被接受，因此我們目前可以分享的一切都只是猜測。

The next question comes from the line of Navin Jacob of UBS.

下一個問題來自瑞銀集團的納文·雅各布（Navin Jacob）。

Can you hear me okay?

你聽得到我說話嗎？

Yes.

是的。

Okay, perfect. Sorry. It's -- but -- so a question. There have been some emerging publications or prepublications on potential mutations around the spike protein, including the receptor-binding domain. Wondering if you've -- how you're thinking about that and also wondering if you're going to be publishing your preclinical data for BNT162, please.

好的，完美。對不起。這是——但是——這是一個問題。已經有一些關於刺突蛋白周圍潛在突變的新興出版物或預出版物，包括受體結合域。想知道您是否對此有什麼想法，也想知道您是否打算發布 BNT162 的臨床前數據。

Yes. So there are mutations also in the receptor-binding domain as well as in the other regions of spike protein. And this has so far no structural changes but single amino acid changes, and these single amino acid changes might change the biology of the virus.

是的。因此，受體結合域以及刺突蛋白的其他區域也存在突變。到目前為止，它沒有結構變化，只有單一氨基酸的變化，而這些單一氨基酸的變化可能會改變病毒的生物學特性。

So the virus may increase the affinity or reduce the affinity or -- and the disease biology may change, but this type of mutations is not expected to change the responsiveness, the overall responsiveness of the virus towards a vaccine.

因此，病毒可能會增加親和力或降低親和力，或者—疾病生物學可能會發生變化，但這種類型的突變預計不會改變病毒對疫苗的反應性，也就是整體反應性。

And since immune responses which we are generating via vaccine, even if you use just a receptor-binding domain, are extremely polyspecific, and single amino acid changes will not affect neutralizing activity of the vaccine.

由於我們透過疫苗產生的免疫反應，即使只使用受體結合結構域，也是極其多特異性的，單一胺基酸的變化不會影響疫苗的中和活性。

That's very clear -- and last one. Go ahead. Sorry.

這非常清楚——也是最後一個。前進。對不起。

Second question with regards on -- yes, yes. And the second question with regard -- yes. The second question, with regard to the preclinical publications. So it will take a few more weeks until we have a full data set. You are aware that we are always trying to have a deeply scientific publication not only showing preclinical data but providing also some sort of understanding, and therefore we expect that this will not happen in the next 2 months.

第二個問題是關於──是的，是的。第二個問題是──是的。第二個問題，關於臨床前出版品。因此，我們還需要幾週時間才能獲得完整的資料集。您知道，我們一直在努力發表深入的科學出版物，不僅顯示臨床前數據，而且還提供某種理解，因此我們預計這不會在未來 2 個月內發生。

Perfect. Then last question, sorry, for me. Could -- I think I just missed it and it's probably there in your slide, but could we get an update on time lines for data update for BNT312, your sialyl Lewis A antibody asset, please?

完美的。那麼最後一個問題，對不起，對我來說。我想我只是錯過了它，它可能就在您的幻燈片中，但是我們能否了解您的唾液酸路易斯 A 抗體資產 BNT312 數據更新的時間表？

312?

312？

321, 321.

321、321。

321 is --.

321 是——。

CA 19-9.

CA 19-9。

CA 19-9. So the CA 19-9, just beginning 2020, was restarted in pancreatic cancers and other CA 19-9-positive tumors. We are collecting data. It might be that we update on the recruitment of patients into this trial late 2020, but we will not provide substantial updates for the clinical trials in 2020 but most likely mid-2021.

CA 19-9。因此，2020 年剛開始的 CA 19-9 在胰臟癌和其他 CA 19-9 陽性腫瘤中重新啟動。我們正在收集數據。我們可能會在 2020 年底更新該試驗的患者招募情況，但我們不會在 2020 年提供臨床試驗的實質更新，但最有可能在 2021 年中期提供。

The next question comes from the line of Arlinda Lee of Canaccord.

下一個問題來自 Canaccord 的 Arlinda Lee。

I had a few on 162. You talked about having, by the end of June, 50 to 70 subjects worth of data. I'm wondering how granular that data might be; and if you will have data from just the first candidate or some of the other candidates as well; and if there might be -- on the granularity side, whether you might have enough granularity on the volunteer background. And as well, what kind of things are you looking for in order to move forward with one formulation versus -- or one candidate versus another one?

我在 162 上有一些數據。您談到，到 6 月底，已有 50 到 70 個受試者的數據。我想知道這些數據的粒度有多大；如果您只有第一位候選人或其他一些候選人的資料；如果可能的話，在粒度方面，你是否對志工背景有足夠的細微差別。另外，為了推進一種方案與——或者一個候選人與另一個候選人之間的比較，您正在尋找什麼樣的東西？

Yes, yes. So as you know, the trial is -- has started with the first candidate, which is the nucleoside-modified RBD domain. We have also started a second candidate, which is a uridine-based RNA, encoding also for RBD domain. We are going to start with the 2 other candidates in the time frame of the next 2 to 3 weeks. And based on this staggered approach, the data updates for these candidates will be also provided in a staggered manner.

是的是的。如您所知，試驗已經從第一個候選藥物開始，即核苷修飾的 RBD 結構域。我們也開始了第二個候選者，它是一種基於尿苷的 RNA，也編碼 RBD 結構域。我們將在接下來的 2 至 3 週內從另外 2 名候選人開始。而基於這種交錯的方式，這些候選者的資料更新也會以交錯的方式提供。

The U.S. trial has started to recruit and the German trial also started to recruit subjects below the age of 55, and we will start recruitment of subjects older than 55 once we have safety data in U.S. available, yes. So that means also the information with regard to the immunogenicity and safety in subjects older than 55 will come with a certain set of delay.

美國的試驗已經開始招募55歲以下的受試者，德國的試驗也開始招募55歲以下的受試者，一旦我們獲得了美國的安全數據，我們將開始招募55歲以上的受試者，是的。因此，這也意味著有關 55 歲以上受試者的免疫原性和安全性的資訊將有一定的延遲。

We will now take our last question from the line of Robert Burns of H.C. Wainwright.

現在我們將回答 H.C. 的羅伯特·伯恩斯 (Robert Burns) 提出的最後一個問題。溫賴特。

Just one for me, if I may, regarding ASCO 2020. I noticed that it seems to be that there is going to be the presentation of our poster regarding BNT111. And I was curious as to what sort of incremental updates we can expect to see within the patients from -- that had metastatic lesions at baseline as well as whether we're going to see any information on the patients that had no macroscopic tumor lesions at baseline.

如果可以的話，我只想說一個關於 ASCO 2020 的問題。我注意到似乎將會展示我們關於 BNT111 的海報。我很好奇我們可以期望在基線時有轉移性病變的患者中看到什麼樣的增量更新，以及我們是否會看到有關基線時沒有肉眼可見腫瘤病變的患者的任何信息。基線。

Yes. So the -- so we will -- so the planned publication for BNT111 is -- will consist of data that have been presented, I think, and last updated in end of last year and will provide mechanistics insights, will provide deep immunological insights and will provide correlation -- correlated data, how immune responses and other biomarkers correlated with objective responses and clinical control.

是的。因此，我們將 - 所以 BNT111 的計劃出版物是 - 我認為，將包含已提交的數據，以及去年年底最後更新的數據，並將提供機制見解，將提供深入的免疫學見解和將提供相關性— —相關數據，免疫反應和其他生物標記如何與客觀反應和臨床控制相關。

And actually, this data provided also the basis for discussing with FDA to start the randomized Phase II study which is going to -- which is expected to start in end of this year. So we are still collecting data in patients who had no metastatic lesions at the beginning. So this data is a readout based on relapse-free survival. Those data are still maturing. We expect that this data update will happen in the second half of 2020, yes, most likely in the upcoming meeting, either ESMO or SITC.

實際上，這些數據也為與 FDA 討論啟動隨機 II 期研究提供了基礎，該研究預計將於今年年底開始。所以我們仍在收集一開始沒有轉移病灶的病患的資料。所以這個數據是基於無復發生存率的讀數。這些數據仍在成熟中。我們預計此數據更新將在 2020 年下半年進行，是的，最有可能在即將舉行的會議（ESMO 或 SITC）中進行。

We have no further questions at this time. Please continue.

目前我們沒有進一步的問題。請繼續。

Okay. Well, thank you, everyone, for joining the call.

好的。好的，謝謝大家加入我們的電話會議。

That concludes the conference for today. Thank you for participating. You may all disconnect.

今天的會議到此結束。感謝您的參與。你們都可以斷開連線。