Biontech SE (BNTX) 2022 Q1 法說會逐字稿

Welcome to the BioNTech First Quarter 2022 Update Call. I would like to hand the call over to the Vice President of Investor Relations and Strategy, Sylke Maas. Please go ahead, Sylke.

歡迎來到 BioNTech 2022 年第一季度更新電話會議。我想將這個電話轉給投資者關係和戰略副總裁 Sylke Maas。請繼續，西爾克。

Good morning and good afternoon, and thank you for joining us today to review BioNTech's First Quarter 2022 Clinical and Operational Progress and Financial Results. A few housekeeping items before we start. Please view the slides that accompany the webcast in the first quarter 2022 press release, both were issued this morning and can be found in the Investors section of our website.

早上好，下午好，感謝您今天加入我們，回顧 BioNTech 的 2022 年第一季度臨床和運營進展以及財務業績。在我們開始之前有一些家務。請查看 2022 年第一季度新聞稿中網絡廣播隨附的幻燈片，兩者均於今天上午發布，可在我們網站的“投資者”部分找到。

As outlined on Slide 2, today's presentation, we'll be making several forward-looking statements. These forward-looking statements include, but are not limited to, our current COVID-19 vaccine revenues as they include figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2022, the continued global demand for our COVID-19 vaccine, our target vaccine production capacity for 2022 and beyond, our ability to supply our COVID-19 vaccine, the planned next steps in our pipeline programs, the timing for enrollment initiation, completion and reporting of data from our preclinical studies and our clinical trials, the timing of and our ability to obtain and maintain regulatory approval for our product candidates and other risks described in our filings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20-F.

正如今天的演示文稿幻燈片 2 中所述，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當前的 COVID-19 疫苗收入，因為它們包括來自我們合作夥伴提供的初步估計的數據、我們對 2022 年的估計財務業績、全球對我們 COVID-19 的持續需求。 19 種疫苗、我們 2022 年及以後的目標疫苗生產能力、我們供應 COVID-19 疫苗的能力、我們管道計劃中計劃的下一步、開始註冊的時間、完成和報告我們的臨床前研究和臨床數據我們向美國證券交易委員會提交的文件（包括我們最近的 20-F 表格年度報告）中描述的試驗、獲得和維持對我們的產品候選人的監管批准的時間和能力以及其他風險。

As 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 today, shared today during this conference call and webcast.

由於實際結果可能與我們目前的預期不同，因此請注意不要過分依賴任何前瞻性陳述，這些陳述僅在今天發表，在今天的電話會議和網絡直播中分享。

Also, please note that slides 3 and 4 provide detailed and important safety information regarding our COVID-19 vaccine. Finally, you can see the agenda for today's call on Slide 5.

另請注意，幻燈片 3 和 4 提供了有關我們 COVID-19 疫苗的詳細而重要的安全信息。最後，您可以在幻燈片 5 上看到今天電話會議的議程。

It's my pleasure to introduce the members of BioNTech's management team participating in today's call. I'm joined today by our CEO and Co-Founder, Ugur Sahin; Ozlem Tureci, our Chief Medical Officer and Co-Founder; Jens Holstein, our Chief Financial Officer; and Ryan Richardson, our Chief Strategy Officer.

我很高興介紹參與今天電話會議的 BioNTech 管理團隊的成員。今天，我們的首席執行官兼聯合創始人 Ugur Sahin 加入了我的行列； Ozlem Tureci，我們的首席醫療官兼聯合創始人； Jens Holstein，我們的首席財務官；和我們的首席戰略官 Ryan Richardson。

I would like to turn the call over to Ugur Sahin.

我想把電話轉給 Ugur Sahin。

Thank you, Sylke. Good morning and good afternoon, and a warm welcome to all participants and thank you for your continued support. Today, I'm happy to provide you an overview about the key highlights from the first quarter and objectives for the year. Our team will provide further details, and then we will open the call for questions.

謝謝你，西爾克。早上好，下午好，熱烈歡迎所有參與者，感謝您一直以來的支持。今天，我很高興為您概述第一季度的主要亮點和今年的目標。我們的團隊將提供更多詳細信息，然後我們將打開問題電話。

Starting on Slide 6. Let me remind everyone about a few features of our company. Our vision is to harness the immune system to fight human diseases. Our response to the COVID-19 pandemic provided us with the unique opportunity to help protect well over 1 billion people with our first approved product. It provided us also a historic chance to accelerate our progress towards our long-term vision to bring the next generation of immunotherapy to patients.

從幻燈片 6 開始。讓我提醒大家我們公司的一些特點。我們的願景是利用免疫系統來對抗人類疾病。我們對 COVID-19 大流行的反應為我們提供了獨特的機會，通過我們的第一個獲批產品幫助保護超過 10 億人。它還為我們提供了一個歷史性的機會，可以加速實現我們為患者帶來下一代免疫療法的長期願景。

With a fully integrated spectrum of competencies for biopharmaceutical drug development, covering discovery, translational research, development, GMP manufacturing and commercial capabilities, we are well positioned for success. We are pursuing a technology-agnostic solution-focused multi-platform strategy and have built an innovation engine that covers various emerging technologies.

憑藉全面整合的生物製藥藥物開發能力，涵蓋發現、轉化研究、開發、GMP 製造和商業能力，我們為成功做好了充分準備。我們正在追求以技術無關的解決方案為重點的多平台戰略，並建立了一個涵蓋各種新興技術的創新引擎。

We are advancing a diversified product pipeline of immunotherapies that aim to address high unmet medical needs in oncology and multiple infectious disease indications. We are building a 21st century immunotherapy powerhouse with a mission anchored to our strong sense of global social responsibility. We seek to make a positive impact on global health and democratize access to cutting-edge medicines.

我們正在推進多元化的免疫療法產品線，旨在解決腫瘤學和多種傳染病適應症方面未得到滿足的高度醫療需求。我們正在建設一個 21 世紀的免疫治療強國，其使命基於我們強烈的全球社會責任感。我們尋求對全球健康產生積極影響，並使獲得尖端藥物的機會民主化。

Highlights for the first quarter are summarized on Slide 7. Our solid performance continued in the first quarter of 2022, following a strong fourth quarter in 2021. In the first quarter, we reported total revenues of EUR 6.4 billion. We signed our first pandemic preparedness contract with the Federal Republic of Germany that runs through 2027. The framework agreement is aimed at pandemic preparedness, including development, manufacturing and supply of mRNA vaccines in emerging situations in Germany.

幻燈片 7 總結了第一季度的亮點。繼 2021 年第四季度的強勁表現之後，我們在 2022 年第一季度繼續保持穩健的表現。第一季度，我們報告的總收入為 64 億歐元。我們與德意志聯邦共和國簽署了第一份到 2027 年的大流行防範合同。該框架協議旨在防範大流行，包括在德國新出現的情況下開發、製造和供應 mRNA 疫苗。

During the first quarter, we also engaged into collaborations that complement our internal innovation engine. The Matinas collaboration combines our mRNA vaccine development expertise and Matinas' Lipid Nanocrystal delivery platform technology to advance novel formulations for mRNA vaccines, including a potential formulation for oral vaccines. With Regeneron, we plan to jointly conduct clinical trials, evaluating FixVac candidate, BNT116, in combination with Libtayo for the treatment of advanced non-small cell lung cancer.

在第一季度，我們還參與了補充我們內部創新引擎的合作。 Matinas 的合作結合了我們的 mRNA 疫苗開發專業知識和 Matinas 的脂質納米晶體遞送平台技術，以推進 mRNA 疫苗的新配方，包括口服疫苗的潛在配方。我們計劃與 Regeneron 聯合開展臨床試驗，評估 FixVac 候選藥物 BNT116與 Libtayo 聯合用於治療晚期非小細胞肺癌。

Our impact on human health and economy around the globe continued in 2022. We have invoiced approximately 750 million doses of our COVID-19 vaccines globally in 2022 and to end of the first quarter. In terms of expanding our (inaudible) older population, we recently received certain approvals. This includes a 4th dose in adults, aged 50 and over, as well as in certain types of immunocompromised patients aged 30 years and older. Our pediatric indications now includes vaccinations in children, aged 5 and over, as well as booster for those 12 and up in multiple geographies.

到 2022 年，我們對全球人類健康和經濟的影響仍在繼續。到 2022 年到第一季度末，我們已在全球開發了大約 7.5 億劑 COVID-19 疫苗。在擴大我們（聽不清）老年人口方面，我們最近獲得了某些批准。這包括 50 歲及以上的成人以及 30 歲及以上的某些類型的免疫功能低下患者的第 4 劑。我們的兒科適應症現在包括 5 歲及以上兒童的疫苗接種，以及多個地區 12 歲及以上兒童的加強免疫。

On the oncology front, our first RiboMab program, BNT141, entered a first in-human study in solid tumors in January. BNT141 is an mRNA encoded IgG antibody, targeting Claudin-18.2. In April, we presented a promising preliminary clinical data from 14 evaluable patients in our Phase I/II trial of BNT211, our next-generation Claudin-6, targeting CAR-T cells in solid tumors at the AACR Annual Meeting. We documented first antitumor effects even at the lowest CAR-T cell dose in heavily treated patient population pointing to an encouraging activity of targeting Claudin 6 and our CARVac approach.

在腫瘤學方面，我們的第一個 RiboMab 項目 BNT141 在 1 月份進入了第一個實體瘤人體研究。 BNT141 是一種 mRNA 編碼的 IgG 抗體，靶向 Claudin-18.2。 4 月，我們在 AACR 年會上展示了來自 14 名可評估患者的有希望的初步臨床數據，該數據來自我們的下一代 Claudin-6 BNT211 的 I/II 期試驗，該試驗針對實體瘤中的 CAR-T 細胞。我們在重度治療的患者群體中記錄了即使在最低 CAR-T 細胞劑量下的首次抗腫瘤效果，這表明靶向 Claudin 6 和我們的 CARVac 方法的活動令人鼓舞。

Slide 8. Since the start of the pandemic, we have delivered nearly 3.4 billion doses of COMIRNATY to people located in more than 175 countries and regions, demonstrating our strong global position in the fight against COVID-19. We remain on track to achieve our pledge to deliver a total of more than 2 billion doses to low and middle income countries by the end of 2022.

幻燈片 8. 自大流行開始以來，我們已向 175 多個國家和地區的人們提供了近 34 億劑 COMIRNATY，顯示了我們在抗擊 COVID-19 方面的強大全球地位。我們仍有望實現到 2022 年底向低收入和中等收入國家提供總計超過 20 億劑疫苗的承諾。

To stay ahead of COVID-19, we continue to innovate and optimize our vaccine. This year, we have introduced a ready-to-use formulation that does not require [dual-event] and received approval for a shelf life extension from 9 to 12 months when stored at minus 90 to minus 60 Celsius.

為了保持領先於 COVID-19，我們將繼續創新和優化我們的疫苗。今年，我們推出了一種無需 [雙重事件] 的即用型配方，並獲准在 -90 至 -60 攝氏度下儲存時將保質期從 9 個月延長至 12 個月。

To further expand the label to pediatric populations, we have filed for the approval of boosters in children 5 to under 12 years old. The filings were supported by recent positive data demonstrating that at 3rd dose increased neutralizing antibodies sixfold in this age group. We are also evaluating a 3-dose primary regimen in children 6 months to under 5 years old and expect data in the coming weeks.

為了進一步將標籤擴展到兒科人群，我們已申請批准用於 5 至 12 歲兒童的加強劑。這些申請得到了最近的積極數據的支持，這些數據表明，在該年齡組中，第 3 劑中和抗體增加了六倍。我們還在評估 6 個月至 5 歲以下兒童的 3 劑主要治療方案，預計未來幾週會有數據。

As part of our approach to pandemic preparedness, we are collaborating with InstaDeep on an early warning system that analyzes globally available sequencing data and predicts high-risk variants of SARS-CoV-2. This warning system allows us to rapidly adapt our vaccine product candidate in a data guided way.

作為我們應對大流行的方法的一部分，我們正在與 InstaDeep 合作開發一個預警系統，該系統分析全球可用的測序數據並預測 SARS-CoV-2 的高風險變體。該警告系統使我們能夠以數據引導的方式快速調整我們的候選疫苗產品。

As part of our preemptive approach to variant, we have an ongoing comprehensive development program, where we are evaluating several follow-on and next-generation COVID-19 vaccines, including variant-adapted vaccines. We also have initiated a broad research program to study the immune profile after vaccinations, boosters and breakthrough flu infection. This research program is informing our vaccine development strategy.

作為我們先發製人的變體方法的一部分，我們有一個持續的綜合開發計劃，我們正在評估幾種後續和下一代 COVID-19 疫苗，包括適應變體的疫苗。我們還啟動了一項廣泛的研究計劃，以研究接種疫苗、加強劑和突破性流感感染後的免疫狀況。該研究計劃正在為我們的疫苗開發戰略提供信息。

To conclude my opening remarks, as shown on Slide 9, we are building a differentiated pipeline that we believe could usher in a new era of immunotherapy to multiple ways of innovation. Our COVID-19 vaccine program is enabling a transformation of our company that will position us to broaden and accelerate our pipeline towards the market, consistent with our vision to transform medicine.

結束我的開場白，如幻燈片 9 所示，我們正在建立一個差異化的管道，我們相信這可以為多種創新方式帶來免疫治療的新時代。我們的 COVID-19 疫苗計劃正在實現我們公司的轉型，這將使我們能夠擴大和加速我們的市場渠道，這與我們改變醫學的願景一致。

In oncology, we have 16 programs in 20 ongoing clinical trials, including 5 randomized Phase II trials. In infectious diseases, we have 1 ongoing Phase I program and more than 10 preclinical programs, 4 of which we expect to bring into the clinic this year. Our aim is to bring multiple new products in oncology and infectious disease to market over the next 3 to 5 years.

在腫瘤學方面，我們在 20 項正在進行的臨床試驗中擁有 16 個項目，其中包括 5 項隨機 II 期試驗。在傳染病方面，我們有 1 個正在進行的 I 期項目和 10 多個臨床前項目，其中 4 個我們預計今年將進入臨床。我們的目標是在未來 3 到 5 年內將多種腫瘤學和傳染病新產品推向市場。

We believe that our technology innovation engine has the potential to address a broad set of diseases beyond our current core disease pillar of oncology and infectious diseases. There's multiple programs underway in new disease areas that are in the lead candidate selection phase, advancing our technology into these new areas expands the future for BioNTech and will support our vision in the long term.

我們相信，我們的技術創新引擎有潛力解決我們當前的腫瘤學和傳染病核心疾病支柱之外的一系列疾病。在處於領先候選者選擇階段的新疾病領域正在進行多個項目，將我們的技術推進到這些新領域擴展了 BioNTech 的未來，並將長期支持我們的願景。

With that, I will turn the call over to Ozlem.

有了這個，我會把電話轉給 Ozlem。

Thank you, Ugur. I'm delighted to speak with everyone today and provide our pipeline update. Our COVID-19 vaccine R&D strategy on Slide 11 rests on 3 pillars: landscape research, product research and product development. Our landscape research elucidates how the virus evolves within the context of vaccine and infection-induced immunity. We are studying how immunity is being shaped over time by iterations of vaccinations, ongoing boosters and infections with different variants of concern.

謝謝你，烏古爾。我很高興今天與大家交談並提供我們的管道更新。我們在幻燈片 11 上的 COVID-19 疫苗研發戰略基於 3 個支柱：景觀研究、產品研究和產品開發。我們的景觀研究闡明了病毒如何在疫苗和感染誘導免疫的背景下進化。我們正在研究免疫是如何隨著時間的推移通過反復接種疫苗、持續加強和不同關注變體的感染而形成的。

The data we are continuously generating will inform our evolving response to the pandemic. A recent research study has added to our understanding and may be crucial in the development of next-generation vaccines. These data have been submitted for peer review in a [hiring] journal and published on a preprint server. In the study, we evaluated the sera of individuals who had breakthrough infections with Omicron after either 2 or 3 doses of original vaccine to determine the impact of Omicron infection on immunity.

我們不斷生成的數據將為我們對大流行的不斷變化的反應提供信息。最近的一項研究增加了我們的理解，可能對下一代疫苗的開發至關重要。這些數據已在 [招聘] 期刊中提交給同行評審，並發佈在預印本服務器上。在這項研究中，我們評估了在接種 2 劑或 3 劑原始疫苗後出現 Omicron 突破性感染的個體的血清，以確定 Omicron 感染對免疫力的影響。

We found that the exposure to Omicron spike by Omicron breakthrough infection of vaccinated individuals strongly enhanced with not only neutralizing activity against Omicron BA.1, but broadly augments immunity, including against Omicron BA.2, previous SARS-CoV-2 variants of concern and even SARS-CoV-1. Omicron breakthrough infection mediated a broad B-cell recall response primarily for expanded memory B cells that recognize antigens shared broadly by different variants rather than inducing new B cells against strictly Omicron-specific antigens.

我們發現，接種疫苗個體的 Omicron 突破性感染暴露於 Omicron 尖峰，不僅對 Omicron BA.1 具有中和活性，而且廣泛增強免疫力，包括對 Omicron BA.2、先前關注的 SARS-CoV-2 變體和甚至是 SARS-CoV-1。 Omicron 突破性感染介導了廣泛的 B 細胞回憶反應，主要針對擴展的記憶 B 細胞，這些 B 細胞識別由不同變體廣泛共享的抗原，而不是針對嚴格的 Omicron 特異性抗原誘導新的 B 細胞。

Taken together, these results suggest that despite possible imprinting of immune response by previous vaccination, the preformed B cell memory port can be refocused and quantitatively remodeled by exposure to spike proteins from different strains. We believe this may allow neutralization of variants that [evade] a previously established neutralizing antibody response. The observation also may suggest that a vaccine adapted to Omicron strain spike could similarly reshape the B-cell memory repertoire and therefore may be more beneficial than an extended series of boosters with the existing vaccines directed against the original strain. We believe that the data may also suggest that exposure of ancestral strain vaccine experience individuals to an Omicron spike mono or bivalent vaccine could provide similar cross-strain immunity.

總之，這些結果表明，儘管先前的疫苗接種可能會留下免疫反應的印記，但預先形成的 B 細胞記憶端口可以通過暴露於來自不同菌株的刺突蛋白來重新聚焦和定量重塑。我們相信這可能允許中和[逃避]先前建立的中和抗體反應的變體。該觀察結果還可能表明，適應 Omicron 毒株尖峰的疫苗可以類似地重塑 B 細胞記憶庫，因此可能比使用針對原始毒株的現有疫苗的擴展系列加強劑更有益。我們認為，這些數據還可能表明，接觸過祖傳毒株疫苗的個體接觸 Omicron 刺突單價或二價疫苗可以提供類似的跨毒株免疫。

To be prepared for future challenges, we may face with further evolvement of the virus. We have been engaged since the approval of BNT162b2 in a very robust product research effort to explore various follow-on and novel next-generation vaccines to prevent COVID-19. These are currently in development and several projects may move into the clinic this year. We are evaluating mono and multivalent vaccine, T cell-enhancing approaches and pan-coronavirus covering vaccine concepts.

為了應對未來的挑戰，我們可能會面臨病毒的進一步演變。自 BNT162b2 獲批以來，我們一直致力於一項非常強大的產品研究工作，以探索各種後續和新型的下一代疫苗來預防 COVID-19。這些目前正在開發中，今年可能會有幾個項目進入臨床。我們正在評估單價和多價疫苗、T 細胞增強方法和涵蓋疫苗概念的泛冠狀病毒。

Our landscape research helps our product development strategy that currently focuses on responding to the need for vaccine adaptation due to the emergence of Omicron and its top lineages. Our clinical program evaluating the safety, tolerability and immunogenicity of various variant-adapted vaccines in multiple clinical trials is advanced. Emerging data from these trials will be reviewed and discussed with regulators in the coming weeks to determine the appropriate regulatory path forward for either monovalent or bivalent variant-adapted vaccine product candidates.

我們的景觀研究有助於我們的產品開發戰略，該戰略目前專注於響應由於 Omicron 及其頂級血統的出現而對疫苗適應的需求。我們在多項臨床試驗中評估各種變體適應疫苗的安全性、耐受性和免疫原性的臨床計劃已取得進展。這些試驗的新數據將在未來幾週內與監管機構進行審查和討論，以確定單價或二價變體適應疫苗產品候選者的適當監管路徑。

As a reminder, Slide 12 shows our comprehensive clinical response strategy to the Omicron variant. We are investigating different dose schedules of a monovalent Omicron-adapted vaccine, for example, in individuals aged 18 to 55 years, and evaluating bivalent approaches as well. We expect data from these studies will be available in the coming weeks. While there is currently no regulatory consensus on the benefit of Omicron-adapted vaccines, we anticipate regulatory developments as clinically meaningful data become available. As we await the data, we remain prepared to adapt our technology and manufacturing processes to ensure that our vaccine provides robust protection against current and emerging variants of [COVID-19].

提醒一下，幻燈片 12 顯示了我們對 Omicron 變體的綜合臨床反應策略。我們正在研究單價 Omicron 適應疫苗的不同劑量方案，例如，在 18 至 55 歲的個體中，並評估二價方法。我們預計這些研究的數據將在未來幾週內提供。雖然目前沒有關於 Omicron 適應疫苗的益處的監管共識，但我們預計隨著臨床有意義的數據可用，監管會發展。在我們等待數據的同時，我們仍準備調整我們的技術和製造工藝，以確保我們的疫苗針對當前和新出現的 [COVID-19] 變體提供強有力的保護。

Slide 13 highlights our expansive oncology pipeline. That is a result of our comprehensive innovative multi-modality toolbox, and our focused execution throughout 2021 and 2022. We have multiple assets in development across different immune therapeutic modalities with the possible potential to tackle tumors using complementary strategies, either by targeting tumor cells directly or by modulating the immune response against the tumor.

幻燈片 13 突出了我們廣泛的腫瘤學管道。這是我們全面創新的多模式工具箱以及我們在 2021 年和 2022 年重點執行的結果。我們在不同的免疫治療模式中擁有多種資產正在開發中，並有可能通過直接靶向腫瘤細胞的互補策略來解決腫瘤問題或通過調節對腫瘤的免疫反應。

Many of our product candidates can be combined with our pipeline assets. Our oncology pipeline includes the total of 16 product candidates across 4 different drug classes in 20 ongoing clinical trials, 5 of which are randomized Phase II clinical trials. We expect continued pipeline advancement and expansion as well as further data readout from the ongoing trials in 2022.

我們的許多候選產品都可以與我們的管道資產相結合。我們的腫瘤學產品線包括 20 個正在進行的臨床試驗中 4 個不同藥物類別的 16 個候選產品，其中 5 個是隨機 II 期臨床試驗。我們預計管道將繼續推進和擴展，以及 2022 年正在進行的試驗的進一步數據讀出。

We believe that this will be a year of focused execution across our 5 Phase II clinical trials in multiple tumor types, as shown on Slide 14. First, we have 2 Phase II trials ongoing that are evaluating FixVac, our off-the-shelf mRNA vaccine immune therapy platform. BNT111, which is being evaluated in anti-PD-1 refractory/relapsed advanced melanoma, encodes 4 tumor antigens that cover greater than 90% of cutaneous melanoma patients. Our approach may have the potential to improve outcomes when used in combination with anti-PD-1. We have received FDA fast track and orphan drug designations for this program. BNT113, which encodes HPV 16 oncoproteins E6 and E7, is being evaluated in HPV 16 positive, PD-L1-positive head and neck cancer in combination with anti-PD-1.

我們相信，這將是我們在多種腫瘤類型中進行 5 項 II 期臨床試驗集中執行的一年，如幻燈片 14 所示。首先，我們正在進行 2 項 II 期試驗，正在評估我們現成的 mRNA FixVac疫苗免疫治療平台。 BNT111正在抗 PD-1 難治性/復發性晚期黑色素瘤中進行評估，它編碼 4 種腫瘤抗原，覆蓋超過 90% 的皮膚黑色素瘤患者。當與抗 PD-1 結合使用時，我們的方法可能有可能改善結果。我們已收到 FDA 快速通道和該計劃的孤兒藥指定。編碼 HPV 16 癌蛋白 E6 和 E7 的 BNT113 正在與抗 PD-1 聯合用於 HPV 16 陽性、PD-L1 陽性頭頸癌的評估。

Next, we have with our partner, Genentech, 2 individualized neoantigen-based vaccine programs, iNeST programs, evaluating autogene cevumeran, or BNT122, in Phase II trials, 1 in frontline melanoma and 1 in colorectal cancer in the adjuvant setting. If 1 melanoma trial is successful and accepted by regulators, we would unlock the possible use of iNeST as a frontline therapy in combination with anti-PD-1 in anti-PD-1 naive advanced cancers. In colorectal cancer, we aim to address the residual cancer cells that remain after treatment with standard therapy, a key driver of relapse.

接下來，我們與我們的合作夥伴基因泰克（Genentech）進行了 2 個基於新抗原的個體化疫苗項目 iNeST 項目，在 II 期試驗中評估自體基因 cevumeran 或 BNT122，1 個用於一線黑色素瘤，1 個用於結腸直腸癌的輔助治療。如果一項黑色素瘤試驗成功並被監管機構接受，我們將解鎖 iNeST 作為一線療法與抗 PD-1 聯合治療抗 PD-1 初始晚期癌症的可能性。在結直腸癌中，我們的目標是解決標準療法治療後殘留的癌細胞，這是複發的關鍵驅動因素。

Finally, BNT311, our bispecific antibody that we are developing with our partner, Genentech, is in an ongoing Phase II study in refractory or recurrent non-small cell lung cancer. This next-generation immunotherapy uses conditional 4-1BB co-stimulation concurrent with PD-L1 blockade with the goal of tumor-targeted enhancement of T cells and natural killer cell function.

最後，我們與合作夥伴基因泰克正在開發的雙特異性抗體 BNT311 正在進行難治性或複發性非小細胞肺癌的 II 期研究。這種下一代免疫療法使用條件性 4-1BB 共刺激與 PD-L1 阻斷同時進行，目標是腫瘤靶向增強 T 細胞和自然殺傷細胞功能。

Turning now to Slide 15. We recently presented promising efficacy and safety data for BNT211, our next-generation CAR-T cell program at the AACR Annual Conference. BNT211 combines 2 of our platforms that we believe have complementary modes of action, Claudin-6 CAR-T cells and the CAR-T cell amplifying RNA vaccine, called CARVac. Based on our lipoplex technology used in other cancer -- vaccine programs. Claudin-6 CAR-T cells are equipped with a second-generation chimeric antigen receptor of high sensitivity and specificity for the passing of embryonic, tumor-specific antigen Claudin-6. Claudin-6 is absent in healthy adult tissue, yet frequently expressed in high medical need cancers, making this tumor antigen an ideal candidate for CAR-T cell therapy.

現在轉到幻燈片 15。我們最近在 AACR 年會上展示了我們的下一代 CAR-T 細胞項目 BNT211 的有希望的療效和安全性數據。 BNT211結合了我們認為具有互補作用模式的兩個平台，即 Claudin-6 CAR-T 細胞和 CAR-T 細胞擴增 RNA 疫苗，稱為 CARVac。基於我們用於其他癌症的 lipoplex 技術——疫苗項目。 Claudin-6 CAR-T 細胞配備了第二代嵌合抗原受體，對胚胎腫瘤特異性抗原 Claudin-6 的傳遞具有高敏感性和特異性。 Claudin-6 在健康成人組織中不存在，但經常在高醫療需求癌症中表達，使這種腫瘤抗原成為 CAR-T 細胞治療的理想候選者。

In preclinical studies, we demonstrated that CARVac drives in vivo expansion of transferred CAR-T cells, increasing their persistence and efficacy. BNT211 aims to overcome CAR-T cell therapy limitation in patients with solid tumors. The ongoing [test in] human Phase I/II trial is evaluating the safety and efficacy of Claudin-6 CAR-T cells as monotherapy and in combination with CARVac in patients with Claudin-6 positive relapsed or refractory advanced solid tumors.

在臨床前研究中，我們證明了 CARVac 推動了轉移的 CAR-T 細胞的體內擴增，從而提高了它們的持久性和功效。 BNT211旨在克服實體瘤患者的 CAR-T 細胞治療限制。正在進行的 [測試] 人體 I / II 期試驗正在評估 Claudin-6 CAR-T 細胞作為單一療法以及與 CARVac 聯合用於 Claudin-6 陽性複發或難治性晚期實體瘤患者的安全性和有效性。

We are testing 3-dose levels of Claudin-6 CAR-T cells as monotherapy dose escalation as well as in combination with fixed dose of RNA vaccine. The subsequent dose expansion cohorts will include patients with ovarian, testicular and endometrial cancer as well as other rare Claudin-6 positive cancer types, such as sarcoma.

我們正在測試 3 劑量水平的 Claudin-6 CAR-T 細胞作為單藥劑量遞增以及與固定劑量 RNA 疫苗的組合。隨後的劑量擴展隊列將包括患有卵巢癌、睾丸癌和子宮內膜癌以及其他罕見的 Claudin-6 陽性癌症類型（如肉瘤）的患者。

Slide 16 provides a summary of AACR data. The presentation included data from 16 heavily pretreated patients, who received Claudin-6 CAR-T cells alone at 2 dose levels, 1x10 to the 7 and 1x10 to the 8 or combined with CARVac after the lymphodepletion. Tumor indications included 8 testicular cancer patients, 4 ovarian cancer patients and 1 patient each for endometrial cancer, fallopian tube cancer, sarcoma and gastric cancer. The results demonstrated a tolerable safety profile for both the CAR-T cells as monotherapy and when combined with CARVac as 8 patients experienced cytokine release syndrome Grade I to II, which was manageable with tocilizumab, with no signs of neurotoxicity seen.

幻燈片 16 提供了 AACR 數據的摘要。該演示文稿包括來自 16 名經過大量預處理的患者的數據，他們單獨接受了 2 個劑量水平的 Claudin-6 CAR-T 細胞，1x10 到 7 和 1x10 到 8 或在淋巴清除後與 CARVac 聯合使用。腫瘤適應症包括睾丸癌8例，卵巢癌4例，子宮內膜癌、輸卵管癌、肉瘤、胃癌各1例。結果表明，CAR-T 細胞作為單一療法和與 CARVac 聯合使用時具有可耐受的安全性，因為 8 名患者經歷了 I 級至 II 級細胞因子釋放綜合徵，使用托珠單抗可以控制，沒有發現神經毒性跡象。

So far, 2 dose-limiting toxicities were observed, both were manageable and patients fully recovered. One was hemophagocytic lymphohistiocytosis observed in the combination part at dose level 2. The other observed in the monotherapy cohort at dose level 2 was prolonged cytopenia in a testicular cancer patient with a recent relapse on high-dose chemotherapy and autologous stem cell transplantation. A new cohort with reduced lymphodepletion chemotherapy was subsequently opted to avoid prolonged cytopenia in testicular cancer patients with a history of high-dose chemotherapy.

到目前為止，觀察到 2 種劑量限制性毒性，兩者都是可控的，患者完全康復。一個是在劑量水平 2 的組合部分中觀察到的噬血細胞性淋巴組織細胞增多症。另一個是在劑量水平 2 的單藥治療隊列中觀察到的另一個是最近在大劑量化療和自體幹細胞移植中復發的睾丸癌患者的長期血細胞減少。隨後選擇了一個減少淋巴耗竭化療的新隊列，以避免有大劑量化療史的睾丸癌患者出現長時間的血細胞減少。

The maximum tolerated dose has not yet been reached. The preliminary efficacy data showed encouraging signs of clinical activity with an overall disease control rate of 86% and an overall response rate of 43%, with partial response observed in patients with testicular and ovarian cancer. 5 patients with testicular cancer were treated at 1x10 to the 8 CAR-T cell dose level and showed encouraging responses with an objective response rate of 80% and a disease control rate of 100%. 1 patient had a complete response, 3 had partial responses and 1 had stable disease. This sub-analysis includes 1 additional patient with partial response that received a reduced lymphodepletion regimen.

尚未達到最大耐受劑量。初步療效數據顯示出令人鼓舞的臨床活動跡象，總體疾病控制率為 86%，總體緩解率為 43%，在睾丸癌和卵巢癌患者中觀察到部分緩解。 5 名睾丸癌患者接受了 1x10 至 8 CAR-T 細胞劑量水平的治療，並顯示出令人鼓舞的反應，客觀反應率為 80%，疾病控制率為 100%。 1例完全緩解，3例部分緩解，1例病情穩定。該子分析包括另外 1 名部分緩解的患者，該患者接受了減少的淋巴清除方案。

The addition of CARVac supported CAR-T engraftment and mediated physiological expansion plus upregulation of survival pathways in patients receiving the combination. We also observed deepening of responses over time and continuing long-term persistence of CAR-T in some patients with CAR-T persistence lasting beyond 150 days post infusion.

CARVac 的添加支持 CAR-T 植入並介導生理擴張以及接受聯合治療的患者生存途徑的上調。我們還觀察到，隨著時間的推移，CAR-T 持續存在超過 150 天的一些患者的 CAR-T 持續長期持續存在。

Slide 17 shows the CAR-T engraftment, all 16 patients showed robust CAR-T cell engraftment with peak expansion 10 to 17 days after infusion, reaching cell frequencies above 10 to the 8, total cell count at the 10 to the 8 dose level. We observed that incremental improvement of CAR-T cell expansion, either through a higher dose level or by adding the CARVac vaccine translated into clinical activity and response.

幻燈片 17 顯示了 CAR-T 植入，所有 16 名患者均顯示出強大的 CAR-T 細胞植入，在輸注後 10 至 17 天達到峰值擴增，細胞頻率達到 10 至 8 以上，總細胞計數為 10 至 8 劑量水平。我們觀察到 CAR-T 細胞擴增的增量改善，無論是通過更高的劑量水平還是通過添加 CARVac 疫苗轉化為臨床活性和反應。

Slide 18 provides an overview of the preliminary signs of clinical activity. 14 patients were evaluable for efficacy assessment, with at least 1 scan 6 weeks post infusion. 6 patients showed partial responses and an additional 5 patients had stable disease, with shrinkage of target lesions as shown in gray diamonds with green outline. 1 patient had no change from baseline and 2 patients had no signs of clinical activity, both of which were rapidly progressing prior to adoptive cell transfer. This resulted in an objective response rate of 43% and a disease control rate of 86% across all patients.

幻燈片 18 概述了臨床活動的初步跡象。 14 名患者可進行療效評估，輸注後 6 周至少進行 1 次掃描。 6 名患者出現部分緩解，另有 5 名患者病情穩定，靶病灶縮小，如帶綠色輪廓的灰色菱形所示。 1 名患者與基線相比沒有變化，2 名患者沒有臨床活動跡象，這兩者在過繼細胞轉移之前都在迅速發展。這導致所有患者的客觀緩解率為 43%，疾病控制率為 86%。

At 12 weeks, 4 of the 6 patients with a partial response showed deepening and durability of responses with 1 patient reaching a complete response 18 weeks after infusion. All 4 testicular cancer patients in the higher dose levels had disease control and 3 of these patients showed objective responses. In addition, 1 testicular cancer patient showed a partial response after infusion of the lowest CAR-T dose level in combination with CARVac. At the very bottom of the slide under the gray bar, we wanted to share 1 further test secular cancer patient, who has shown a partial response after a reduced lymphodepletion regimen. That patient is not included in the 14 evaluable patients we discussed previously.

在 12 週時，6 名部分反應的患者中有 4 名顯示反應加深和持久，1 名患者在輸注後 18 周達到完全反應。較高劑量水平的所有 4 名睾丸癌患者的疾病均得到控制，其中 3 名患者表現出客觀反應。此外，1 名睾丸癌患者在輸注最低 CAR-T 劑量水平並聯合 CARVac 後表現出部分緩解。在幻燈片的最底部灰色條下方，我們想分享 1 名進一步測試的長期癌症患者，該患者在減少淋巴耗竭方案後表現出部分反應。該患者不包括在我們之前討論的 14 名可評估患者中。

In summary, and most encouragingly, all initial partial responses showed deepening at the second assessment and 1 partial response patient transition to a complete response. The waterfall plot on the left of Slide 19 shows the best response for those 4 testicular and 2 ovarian cancer patients who responded, focusing on the testicular cancer patients, you see a tighter plot on the right depicting the duration of the responses. Besides 1 patient that only received the lower 10 to the 7 dose levels without CARVac, all other patients showed a clinical benefit. All achieved responses showed signs of continuing response durability. This includes the patient whose initial partial response deepened to an ongoing complete response 18 weeks after infusion.

總之，最令人鼓舞的是，所有最初的部分反應在第二次評估時都顯示出加深，1 名部分反應的患者轉變為完全反應。幻燈片 19 左側的瀑布圖顯示了響應的 4 名睾丸癌和 2 名卵巢癌患者的最佳響應，重點關注睾丸癌患者，您會在右側看到更緊密的圖，描繪了響應的持續時間。除了 1 名患者在沒有 CARVac 的情況下僅接受較低的 10 至 7 劑量水平外，所有其他患者均顯示出臨床益處。所有實現的響應都顯示出持續響應持久性的跡象。這包括在輸注後 18 周初始部分反應加深至持續完全反應的患者。

Slide 20 shows scans of 2 testicular cancer patients with tumor regression. Both patients had multiple prior treatments and relapses before receiving BNT211. Patient 1 is a 61-year-old male, diagnosed in 2008. He had previously received 6 lines of treatment and showed a complete response after CAR-T treatment at dose level 2 without CARVac. The large lung metastasis was completely eliminated over time, and the patient remained tumor-free as of latest scan with a serum tumor marker, alpha-fetoprotein at normal values 6 months after infusion.

幻燈片 20 顯示了 2 名患有腫瘤消退的睾丸癌患者的掃描。兩名患者在接受 BNT211 之前都接受過多次治療和復發。患者 1 是一名 61 歲的男性，於 2008 年確診。他之前接受了 6 線治療，並且在沒有 CARVac 的劑量水平 2 的 CAR-T 治療後顯示出完全反應。隨著時間的推移，大的肺轉移被完全消除，並且在輸注後 6 個月，患者的血清腫瘤標誌物甲胎蛋白在最近一次掃描中保持無腫瘤狀態。

Patient 2 is a 56-year-old male testicular cancer patient, diagnosed in 2020, who received dose level 1 and was additionally treated with CARVac. Treatment translated into a robust response, as you can see in those scans, with substantial shrinkage of more than [15] lung metastasis. Following the week 12 scan, the patient had new lesions. As the on treatment biopsy showed positivity for Claudin-6, the patient was redosed with CAR-T cells on day 197, and we have seen a tumor marker response already. We are very encouraged by the safety and activity data, and another data update from the ongoing Phase I/II trial is expected in the second half of 2022.

患者 2 是一名 56 歲的男性睾丸癌患者，於 2020 年確診，接受了 1 級劑量並額外接受了 CARVac 治療。正如您在這些掃描中所見，治療轉化為強大的反應，肺轉移顯著縮小 [15] 以上。在第 12 週掃描後，患者出現新病變。由於治療活檢顯示 Claudin-6 呈陽性，患者在第 197 天再次接受 CAR-T 細胞治療，我們已經看到腫瘤標誌物反應。我們對安全性和活動數據感到非常鼓舞，正在進行的 I/II 期試驗的另一次數據更新預計將在 2022 年下半年進行。

I'd now like to turn over the call to Jens Holstein, who will cover our financial results.

我現在想把電話轉給 Jens Holstein，他將負責我們的財務業績。

Thank you, Ozlem, and a warm welcome to those of you on the phone. I'll start my section by presenting the key highlights for the first quarter of 2022, which you can find on Slide 22. The first quarter of 2022 has been an extraordinary one, which also becomes visible by looking at our key financial highlights. Our total revenues reported for the first quarter of 2022 reached EUR 6.4 billion, reflecting a record figure for the company since its inception. As a consequence of this top line number, we ended the first quarter with an operating result of EUR 4.8 billion and generated earnings per share on a fully diluted basis of EUR 14.24.

謝謝你，Ozlem，並熱烈歡迎電話中的各位。我將通過介紹 2022 年第一季度的主要亮點來開始我的部分，您可以在幻燈片 22 上找到這些亮點。2022 年第一季度是一個非凡的季度，通過查看我們的主要財務亮點也可以看出這一點。我們報告的 2022 年第一季度總收入達到 64 億歐元，創下公司自成立以來的創紀錄水平。由於這一頂線數字，我們在第一季度結束時的經營業績為 48 億歐元，並在完全攤薄的基礎上產生了 14.24 歐元的每股收益。

In respect of cash, we ended the first quarter of 2022 with EUR 6.2 billion of cash and cash equivalents as well as trade receivables of around EUR 12.7 billion. The trade receivables are mainly derived from our collaboration with Pfizer and many remained outstanding due to the contractual settlement of the gross profit share under the collaboration. From our outstanding trade receivables as of March 31, 2022, we had already collected EUR 5.2 billion in cash by mid-April 2022, improving our cash and in turn, reducing our trade receivable position subsequent to the end of Q1 2022.

在現金方面，截至 2022 年第一季度，我們的現金和現金等價物為 62 億歐元，貿易應收賬款約為 127 億歐元。貿易應收賬款主要來自我們與輝瑞的合作，由於合作下毛利份額的合同結算，許多應收賬款仍未結清。從截至 2022 年 3 月 31 日的未償貿易應收賬款中，到 2022 年 4 月中旬，我們已經收取了 52 億歐元的現金，從而改善了我們的現金，進而減少了我們在 2022 年第一季度末之後的貿易應收賬款頭寸。

Continuing with Slide 23, I want to point out how strong our first quarter in 2022 has been. As mentioned before, we have recognized approximately EUR 6.4 billion of COVID-19 vaccine revenues during the first quarter of 2022. This has been the result of an increased order volume, initially placed in late 2021 following the then-emerging Omicron variant. Let me give you some more details on our revenue stream. As a reminder, on our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution-wise.

繼續幻燈片 23，我想指出我們 2022 年第一季度的強勁表現。如前所述，我們在 2022 年第一季度確認了約 64 億歐元的 COVID-19 疫苗收入。這是訂單量增加的結果，最初是在 2021 年底在當時出現的 Omicron 變體之後下達的。讓我給你一些關於我們收入來源的更多細節。提醒一下，在我們的 COVID-19 疫苗合作中，我們、輝瑞和復星醫藥之間已根據營銷和分銷方式分配了領土。

Our COVID-19 vaccine revenues included EUR 4.6 billion, revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners territories. These revenues already represent a net figure, meaning that we generate 100% gross margin of those revenues. As we have mentioned in the past and explained in more detail in our financial statements and filings with the SEC, our profit share is, to some extent, estimated based on preliminary data shared between our collaboration partner, Pfizer and us.

我們的 COVID-19 疫苗收入包括 46 億歐元，該收入與我們在合作夥伴地區銷售 COVID-19 疫苗的毛利份額相關。這些收入已經代表一個淨數字，這意味著我們產生了這些收入的 100% 的毛利率。正如我們過去提到的並在我們的財務報表和提交給美國證券交易委員會的文件中更詳細地解釋的那樣，我們的利潤份額在某種程度上是根據我們的合作夥伴輝瑞和我們之間共享的初步數據估算的。

Our COVID-19 vaccine revenues during the first quarter of 2022 comprised approximately EUR 1.2 billion revenues from direct COVID-19 vaccine sales to customers in our territory, which is significantly driven by the orders that we placed in late 2021 following the then-emerging Omicron variant. Also included in our COVID-19 vaccine revenues during the first quarter of 2022 were EUR 0.6 billion from sales to our collaboration partners.

我們在 2022 年第一季度的 COVID-19 疫苗收入包括約 12 億歐元來自直接向我們境內的客戶銷售 COVID-19 疫苗的收入，這在很大程度上受到我們在當時新興的 Omicron 之後於 2021 年底下達的訂單的推動變體。我們在 2022 年第一季度的 COVID-19 疫苗收入中還包括來自我們合作夥伴的銷售收入 6 億歐元。

Again, we started the year very strong, which we believe gives us a solid foundation for achieving our previously announced guidance for the 2022 financial year. We expect the following quarters to be lower than Q1 given the current situation of the pandemic.

同樣，我們今年開局非常強勁，我們相信這為我們實現之前宣布的 2022 財年指引奠定了堅實的基礎。鑑於當前的大流行情況，我們預計接下來的幾個季度將低於第一季度。

I'll be moving to our financial results for the first quarter of 2022, as shown on Slide 24. Having explained our revenues on the previous slide, let me move now to the cost of sales that reached approximately EUR 1.3 billion in the first quarter of 2022 compared to EUR 0.2 billion for the comparative period in 2021. The increase in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues in our own territories that include the share of gross profit that we owe to our collaboration partner, Pfizer. This increase in cost of sales is additionally attributed to expenses arising from inventory write-offs and for production capacities derived from contracts with direct manufacturing organizations.

我將轉向我們 2022 年第一季度的財務業績，如幻燈片 24 所示。在上一張幻燈片中解釋了我們的收入之後，現在讓我轉向第一季度達到約 13 億歐元的銷售成本2022 年同期為 2 億歐元，而 2021 年同期為 2 億歐元。銷售成本的增加主要是由於確認了與我們在自己領土上的 COVID-19 疫苗收入相關的成本，其中包括我們所欠的毛利潤份額我們的合作夥伴輝瑞。銷售成本的增加還歸因於庫存沖銷產生的費用以及與直接製造組織的合同產生的生產能力。

Research and development expenses were approximately EUR 0.3 billion for the first quarter of 2022 compared to around EUR 0.2 billion for the comparative period in 2021. The increase was mainly due to the recognition of costs related to the production of prelaunch Omicron vaccine products as research and development expenses in the period incurred as well as increase in headcount. The increase was partly offset by lower research and development expenses related to our COVID-19 vaccine program as compared to the prior year period.

2022 年第一季度的研發費用約為 3 億歐元，而 2021 年同期的研發費用約為 2 億歐元。增加的主要原因是，將與生產 Omicron 疫苗產品相關的成本確認為研究和期間發生的開發費用以及員工人數的增加。與去年同期相比，與我們的 COVID-19 疫苗計劃相關的研發費用減少，部分抵消了這一增長。

General and administrative expenses reached EUR 90.8 million for the first quarter of 2022 compared to EUR 38.9 million for the comparative period in 2021. The increase in G&A was mainly due to the increased expenses for purchased management consulting and legal services as well as an increase in headcount.

2022 年第一季度的一般和管理費用達到 9080 萬歐元，而 2021 年同期為 3890 萬歐元。一般和行政費用的增加主要是由於購買管理諮詢和法律服務的費用增加以及人數。

Income taxes were accrued in an amount of EUR 1.3 billion tax expenses for the first quarter of 2022 compared to EUR 0.5 billion tax expenses for the comparative period in 2021. The derived effective income tax rate for the first quarter of 2022 was 26.3% and is expected to be around 28% for the full year. For the first quarter of 2022, net profit reached EUR 3.7 billion compared to EUR 1.1 billion for the comparative period in 2021. Our diluted earnings per share for the first quarter of 2021 amounted to EUR 14.24 compared to EUR 4.39 for the comparative period in 2021.

2022 年第一季度的所得稅費用為 13 億歐元，而 2021 年可比期間為 5 億歐元。2022 年第一季度的派生實際所得稅率為 26.3%，為預計全年約為 28%。 2022 年第一季度，淨利潤達到 37 億歐元，而 2021 年可比期間為 11 億歐元。我們 2021 年第一季度的攤薄每股收益為 14.24 歐元，而 2021 年可比期間為 4.39 歐元.

Moving to Slide 24, that shows that we reiterate our outlook for the 2022 financial year. We started very strong with Q1 2022 and reiterate our full year guidance, even though we have to acknowledge the uncertainty derived from the course of the pandemic and the political uncertainties of the recent months. Considering the unchanged order book of approximately 2.4 billion doses for delivery during the 2022 financial year, we are confirming our estimated COVID-19 vaccine revenues of approximately EUR 13 billion to EUR 17 billion for the full year 2022. For 2022, we also reiterate our planned expenses and CapEx as well as the estimated annual effective income tax rate, which we have summarized for you on this slide.

轉到幻燈片 24，這表明我們重申了對 2022 財年的展望。我們在 2022 年第一季度開局非常強勁，並重申了我們的全年指導方針，儘管我們必須承認大流行病進程帶來的不確定性以及最近幾個月的政治不確定性。考慮到 2022 財年交付的約 24 億劑的訂單保持不變，我們確認 2022 年全年的 COVID-19 疫苗收入估計約為 130 億歐元至 170 億歐元。對於 2022 年，我們還重申我們的計劃費用和資本支出以及估計的年度有效所得稅率，我們在這張幻燈片上為您總結了這些。

And with that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our outlook for 2022 and concluding remarks. Thank you.

因此，我將電話轉給我們的首席戰略官 Ryan Richardson，以了解我們對 2022 年的展望和總結性發言的最新信息。謝謝你。

Thank you, Jens. Turning to Slide 27 and our priorities for the remainder of the year. We continue to focus on supply of our COVID-19 vaccine and the development of our pipeline of next-generation vaccines. Earlier this year, we announced a multiyear pandemic preparedness contract with the German government and discussions with other governments are underway.

謝謝你，詹斯。轉到幻燈片 27 和我們今年剩餘時間的優先事項。我們將繼續專注於 COVID-19 疫苗的供應和下一代疫苗管道的開發。今年早些時候，我們宣布與德國政府簽訂了一份多年期的大流行防範合同，並且正在與其他政府進行討論。

In oncology, we expect our first readout from a randomized Phase II trial in addition to data updates from our ongoing Phase I/II trial of BNT211, our CAR-T cell program for solid tumors. We continue to prepare for the initiation of multiple registrational trials across our pipeline in the next 12 months, and we'll provide further updates on those plans later in the year.

在腫瘤學方面，除了我們正在進行的 BNT211（我們的實體瘤 CAR-T 細胞計劃）的 I/II 期試驗的數據更新外，我們預計我們將首次從隨機 II 期試驗中讀出數據。我們將繼續為在未來 12 個月內在我們的管道中啟動多項註冊試驗做準備，我們將在今年晚些時候提供有關這些計劃的進一步更新。

In infectious disease, we plan to initiate first-in-human clinical trials for 4 additional mRNA vaccine programs in 2022 and in addition to building out our expanding preclinical portfolio.

在傳染病方面，我們計劃在 2022 年啟動另外 4 個 mRNA 疫苗項目的首次人體臨床試驗，並擴大我們不斷擴大的臨床前產品組合。

Additionally, we are accelerating the expansion of our platforms into new therapeutic areas, such as autoimmune disease, regenerative medicine and cardiovascular disease and expect to make lead candidate selections for several programs. To support our focused execution against these goals, we are investing in our foundation, particularly in building out our digital and AI capabilities as well as our global development team to support further pipeline expansion, which we envision in the coming years.

此外，我們正在加速將我們的平台擴展到新的治療領域，例如自身免疫性疾病、再生醫學和心血管疾病，並期望為多個項目選擇主要候選者。為了支持我們針對這些目標的重點執行，我們正在投資於我們的基金會，特別是在建立我們的數字和人工智能能力以及我們的全球開發團隊以支持我們在未來幾年內進一步擴展管道。

On Slide 28, our COVID-19 vaccine order book for the year stands at approximately 2.4 billion doses with approximately 750 million doses invoiced by the end of the first quarter. We expect multiple BNT162b2 data updates throughout the rest of the year, including data for a 3-dose regimen in children, ages 6 months to 5 years, which we expect in the coming weeks. We are evaluating a fourth dose in adults, ages 16 and older, as part of a comprehensive variant-adapted vaccine program. In addition, we expect to disclose safety and immunogenicity data for our Omicron adaptive and bivalent vaccines in the coming weeks, which we'll inform in our ongoing regulatory discussions.

在幻燈片 28 上，我們今年的 COVID-19 疫苗訂單約為 24 億劑，到第一季度末已開具了約 7.5 億劑的發票。我們預計在今年餘下時間將多次更新 BNT162b2 數據，包括我們預計在未來幾週內對 6 個月至 5 歲兒童進行 3 次給藥方案的數據。作為全面的變異適應疫苗計劃的一部分，我們正在評估 16 歲及以上成人的第四劑疫苗。此外，我們預計在未來幾週內披露我們的 Omicron 適應性和二價疫苗的安全性和免疫原性數據，我們將在正在進行的監管討論中告知這些數據。

Moving to Slide 29 and our expected pipeline milestones for 2022. We expect to initiate 7 first-in-human trials this year, including for our mRNA vaccines for shingles, tuberculosis, HSV2 and malaria. In January, we dosed the first patient for our BNT141, RiboMab program, the first program from this exciting new platform. We anticipate our second RiboMab program, BNT142, which encodes a CD3, Claudin-18.2 bispecific antibody, will enter the clinic in the coming months. BNT116, our FixVac program for non-small cell lung cancer, which will be evaluated in combination with Libtayo as part of our expanded Regeneron collaboration, is also expected to enter the clinic in the second half of the year.

轉到幻燈片 29 和我們預期的 2022 年管道里程碑。我們預計今年將啟動 7 項首次人體試驗，包括我們用於帶狀皰疹、肺結核、HSV2 和瘧疾的 mRNA 疫苗。一月份，我們為我們的 BNT141 RiboMab 計劃的第一位患者給藥，這是這個令人興奮的新平台的第一個計劃。我們預計我們的第二個 RiboMab 項目 BNT142 將在未來幾個月內進入臨床，該項目編碼 CD3、Claudin-18.2 雙特異性抗體。 BNT116，我們的非小細胞肺癌 FixVac 項目，將與 Libtayo 聯合評估，作為我們擴大的 Regeneron 合作的一部分，預計也將在下半年進入臨床。

We expect data updates from 3 further programs this year, BNT161 and influenza mRNA vaccine, partnered with Pfizer. And in the second half of 2022, we expect to have a data update from BNT122, our iNeST program, being evaluated in combination with pembrolizumab as a frontline treatment for melanoma. Finally, we expect further data updates this year for our BNT211 CAR-T cell program, which Ozlem highlighted.

我們預計今年與輝瑞合作的 3 個進一步項目的數據更新，即 BNT161 和流感 mRNA 疫苗。並且在 2022 年下半年，我們預計 BNT122（我們的 iNeST 項目）的數據更新，將與派姆單抗聯合評估作為黑色素瘤的一線治療。最後，我們預計今年 BNT211 CAR-T 細胞計劃的數據會進一步更新，Ozlem 強調了這一點。

Before concluding on Slide 30, I would like to remind investors that we will have our Annual General Meeting on June 1, for which detailed information can be found on our website, and we will host our first virtual Capital Markets Day on Wednesday, June 29. I would like to thank our shareholders for their continued support, and we'll now open the floor for questions.

在結束幻燈片 30 之前，我想提醒投資者，我們將在 6 月 1 日舉行年度股東大會，詳細信息可以在我們的網站上找到，我們將在 6 月 29 日星期三舉辦我們的第一個虛擬資本市場日. 我要感謝我們的股東一直以來的支持，我們現在開始提問。

(Operator Instructions) Your first question today comes from the line of Matthew Harrison from Morgan Stanley.

（操作員說明）您今天的第一個問題來自摩根士丹利的 Matthew Harrison。

I guess maybe if you could just give us a little bit more detail on your current thinking around what regulatory discussions you need to have in terms of boosters and what the regulatory pathway, especially in the U.S., is going to look like here? Is your expectation that you can just run a simple bridging study? Or might it be more complicated than that?

我想也許你能不能給我們更多的細節關於你目前的想法，你需要在助推器方面進行哪些監管討論，以及監管途徑，尤其是在美國，會是什麼樣子？您是否期望您可以進行簡單的橋接研究？或者可能比這更複雜？

So I think I can take the question and maybe Ozlem can complement. With the regulatory path towards authorization of a variant-adapted vaccine is not clearly defined yet. We had a number of meetings with regulatory authorities, including FDA and EMA and they propose to see the data on monovalent vaccines as well as bivalent vaccines and would like to make the decision based on the data. As you might have heard, the FDA is planning a VRBPAC Meeting end of June, where they indicated that they would provide a more clearer guidance about the vaccines, vaccines that are preferred for the next season.

所以我想我可以回答這個問題，也許 Ozlem 可以補充。由於尚未明確定義授權適應變體疫苗的監管途徑。我們與包括 FDA 和 EMA 在內的監管機構進行了多次會議，他們建議查看單價疫苗和二價疫苗的數據，並希望根據數據做出決定。正如您可能已經聽說的那樣，FDA 計劃在 6 月底召開 VRBPAC 會議，他們表示將就下一季首選的疫苗提供更清晰的指導。

A similar statement maybe -- was made by the EMA and both authorities seem to prefer an authorization of vaccines in the time frame of August, September, October. So that the process is ongoing. We are generating data for monovalent and different bivalent vaccines, including lower and higher doses, and we'll have the data available for discussion with the authorities. I hope that answers the question. The next question?

EMA 可能也發表了類似的聲明，兩個當局似乎都更喜歡在 8 月、9 月、10 月的時間範圍內授權疫苗。所以這個過程正在進行中。我們正在生成單價和不同二價疫苗的數據，包括較低和較高劑量的疫苗，我們將提供這些數據以供與當局討論。我希望這能回答這個問題。下一個問題？

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

您的下一個問題來自摩根大通的 Cory Kasimov。

I wanted to follow up on this general line of thinking, recognizing that there's data from various COVID programs anticipated over the coming weeks and an uncertain regulatory pathways you just discussed. I'm just curious as to your views on how you see the relative value proposition between an Omicron specific booster compared with a bivalent one over both the short and the longer term.

我想跟進這一總體思路，認識到未來幾週預計會有來自各種 COVID 項目的數據，以及你剛剛討論的不確定的監管途徑。我只是好奇您對 Omicron 特定助推器與短期和長期二價助推器之間的相對價值主張的看法。

Yes. So what we already know and I refer to published data with regard to antibody titers after Omicron 1 infection. And this data clearly indicated in pre-vaccinated individuals, and we have generated data for individuals who have received our vaccine with 2 vaccinations or 3 vaccinations, and we evaluated what is happening of the Omicron exposure. And what we see is that Omicron BA.1 exposure result not only in an increase in antibody types against the Omicron variant, but also against all other variants, including the Delta, Beta, Alpha and the original wild-type variant. So an Omicron exposure in vaccinated individuals really boost both antibody response. And this is -- this was meanwhile, we published that in the meantime, other groups showed the same effects.

是的。因此，我們已經知道，我參考了有關 Omicron 1 感染後抗體滴度的已發表數據。這些數據清楚地顯示在接種前的個體中，我們已經為接種了 2 次或 3 次疫苗的個體生成了數據，我們評估了 Omicron 暴露的情況。我們看到的是，Omicron BA.1 暴露不僅導致針對 Omicron 變體的抗體類型增加，而且還針對所有其他變體，包括 Delta、Beta、Alpha 和原始野生型變體。因此，接種疫苗的個體接觸 Omicron 確實會增强两種抗體反應。這是 - 這是同時，我們發布了與此同時，其他組顯示出相同的效果。

What is important is that an exposure to an Omicron infection, and we expect this is going to happen also in vaccinated individuals, primarily boost memory responses, preestablished memory responses, and naive immune responses will -- most likely take additional months until naive B cells are generated. We do not see a rational advantage combining the moment an Omicron vaccine with another vaccine, but at the end of the day, data count. So that means they are generating data in different individuals. And we will compare the antibody neutralization titers, not only against the prior Omicron variant, but also the newly emerging BA.4 and BA.5 variants as well as former SARS-CoV-2 variants, regardless whether they have -- they might have an impact or not in the future.

重要的是暴露於 Omicron 感染，我們預計這也將發生在接種疫苗的個體中，主要是增強記憶反應、預先建立的記憶反應和幼稚免疫反應 - 很可能需要幾個月的時間，直到幼稚 B 細胞被生成。我們沒有看到將 Omicron 疫苗與另一種疫苗結合起來的合理優勢，但歸根結底，數據很重要。這意味著他們在不同的個體中生成數據。我們將比較抗體中和滴度，不僅與之前的 Omicron 變體，而且還與新出現的 BA.4 和 BA.5 變體以及以前的 SARS-CoV-2 變體進行比較，無論它們是否有 - 他們可能有對未來的影響與否。

Your next question comes from the line of Christopher Zopf from Goldman Sachs.

您的下一個問題來自高盛的 Christopher Zopf。

Congratulations on the quarter. Following up again on the same topic. Based on the (inaudible) conversation that happened earlier that started to lay out the framework for this decision, can you give us a sense of what data do you think they're looking for to try to make this decision. You talked a little bit about kind of neutralizing titers against different variants. Is it that simple? Or are they going to be looking for kind of other aspects as side from safety, of course? And once these data on Omicron specific vaccine are in hand, do you anticipate this may have an impact on other regulatory discussions, like in China, as well?

祝賀本季度。再次跟進同一主題。根據之前發生的（聽不清）對話開始製定此決定的框架，您能否告訴我們您認為他們正在尋找哪些數據來嘗試做出此決定。您談到了針對不同變體的中和滴度。就這麼簡單嗎？或者他們是否會尋找其他方面的安全方面，當然？一旦掌握了有關 Omicron 特定疫苗的這些數據，您是否預計這可能會對其他監管討論產生影響，例如在中國？

Yes, of course, safety is regarded -- will be evaluated and the safety evaluation happens in a few hundreds of subjects who received the booster vaccine. So we don't expect that this is a larger price will be needed also based on the feedback from the regulatory authorities. I can't say -- as already stated, we had a number of conversations with the authorities. And every time they asked for the same data sets, they would like to see monovalent data and bivalent data, but they did not refer what kind of vaccine, monovalent or bivalent, is preferred by them. I assume that this is a topic for the VRBPAC discussion end of June. And I would be -- I don't think that we are going to be surprised by the request of non-expected data set in addition to what we are already generating.

是的，當然，安全性是被考慮的——將被評估並且安全性評估發生在數百名接受加強疫苗的受試者中。因此，根據監管機構的反饋，我們預計不會需要更高的價格。我不能說——如前所述，我們與當局進行了多次對話。並且每次他們要求相同的數據集時，他們都希望看到單價數據和二價數據，但他們沒有提及他們更喜歡哪種疫苗，單價或二價。我假設這是 6 月底 VRBPAC 討論的主題。我會——我認為除了我們已經生成的數據集之外，我們不會對非預期數據集的請求感到驚訝。

I will go to the next question. Your next question comes from Akash Tewari from Jefferies.

我會去下一個問題。您的下一個問題來自 Jefferies 的 Akash Tewari。

So it seems like you and Moderna have been talking up different approaches for an Omicron booster. Moderna seems to be talking of bivalent, while you and Pfizer have been talking of more of a modified spike for patients who aren't naive. Can you talk about how antibody titers for both of these approaches may differ, especially at day 28, where Moderna has mentioned there may not be a big difference between wild-type boosters and an Omicron booster, while you've already shown higher antibodies at day 28, at least with your (inaudible). And then given the uncertainty around the regulatory path forward, in a scenario where you would need robust [BE] data to get onto the market, could there be a scenario where we don't get an Omicron-specific booster in 2022?

因此，您和 Moderna 似乎一直在為 Omicron 助推器討論不同的方法。 Moderna 似乎在談論二價，而您和輝瑞（Pfizer）一直在談論更多針對不幼稚患者的改良尖峰。您能否談談這兩種方法的抗體滴度可能有何不同，尤其是在第 28 天時，Moderna 曾提到野生型加強劑和 Omicron 加強劑之間可能沒有太大差異，而您已經在第 28 天，至少和你的（聽不清）。然後考慮到監管路徑的不確定性，在需要強大的 [BE] 數據才能進入市場的情況下，是否會出現我們在 2022 年得不到 Omicron 專用助推器的情況？

So let me just face the overall situation, in which we are regardless now of the thinking of different companies. We have a situation there, where with an ongoing Omicron pandemic, so 99.8% or 99.9% of all infections are mediated by Omicron sub variants. We have a situation that currently multiple Omicron sub variants exist with different escape profile. And so in Europe, we are seeing sub variants, like Omicron 2.9 or 2.12.1. And from Africa and in the East, we are seeing the BA.4 and BA.5 variants, which appear to have even higher loss of neutralization titers. And any decision of a seasonal vaccine must be in line with the actual variants, which are circulating at the moment. And we and Moderna and other companies started to evaluate Omicron-adapted vaccine, including monovalent and bivalent vaccines.

所以讓我面對大局，我們現在不考慮不同公司的想法。我們有一種情況，即 Omicron 大流行正在進行中，因此 99.8% 或 99.9% 的所有感染都是由 Omicron 亞變體介導的。我們有一種情況，當前存在多個具有不同轉義配置文件的 Omicron 子變體。因此，在歐洲，我們看到了子變體，例如 Omicron 2.9 或 2.12.1。在非洲和東方，我們看到了 BA.4 和 BA.5 變體，它們的中和滴度損失似乎更高。任何季節性疫苗的決定都必須與目前正在流行的實際變體一致。我們和Moderna等公司開始評估Omicron適應疫苗，包括單價和二價疫苗。

So that means all companies will generate this data. And we have to match this data, which has been generated, with evaluating of neutralization titers against the actual variance. And based on that, we have to come to conclusions. That's the way to go. I can't say what is now going to happen in the next few weeks, whether new variants will emerge. But I am pretty sure that any decisions they make by an authority must reflect what is ongoing with regard to the sub variants that are currently in circulation.

這意味著所有公司都會生成這些數據。我們必須將生成的數據與中和滴度的評估與實際方差進行匹配。在此基礎上，我們必須得出結論。這就是要走的路。我不能說接下來幾週會發生什麼，是否會出現新的變種。但我很確定，他們做出的任何決定都必須反映有關當前流通的子變體的正在進行的情況。

Your next question comes from the line of Daina Graybosch from SVB.

您的下一個問題來自 SVB 的 Daina Graybosch。

I'm going to ask another one on this, but maybe a slightly different direction. You mentioned that the paper that you published showing memory B cell responses against some conserved epitopes, after Omicron infection. I think there was a similar one published, I think, from some scientists at Rockefeller. But you looked pretty soon after that breakthrough infection, I think, 40 to 50 days. And I wonder what gives you confidence that those broader B cells and neutralizing antibodies are going to be as durable as maybe neutralizing antibodies more specific against the variant spikes that have some longer durability as we know from previous vaccinations.

我要問另一個人，但方向可能略有不同。你提到你發表的論文顯示了在 Omicron 感染後記憶 B 細胞對一些保守表位的反應。我認為洛克菲勒的一些科學家也發表了類似的文章。但你在突破性感染後不久就看到了，我想，40 到 50 天。我想知道是什麼讓你有信心相信那些更廣泛的 B 細胞和中和抗體將像中和抗體一樣持久，這些抗體可能更特異地對抗我們從以前的疫苗接種中知道的具有更長持久性的變體尖峰。

Daina, the durability of antibodies, in my opinion, is primarily driven by the initial antibody titer. So that is what is happening in the body fluid compartments, including plasma and in the mucosal surfaces. Then we have a second reaction ongoing, which is the continued memory B cell maturation process. Directly after infection, we will have the memory B cell response, as we have shown in our paper, is dominated by preestablished memory B cells, but they will be new naive memory B cells joining into this reaction. But this naive memory B cells will have less mutations and lower affinity antibodies. And this will require several weeks, up to 3 months, until the maturation is established. And then a second booster might have to really generate high affinity antibodies against novel epitope. That is what immunology taught us and that is what we are going to expect. That means antibody titers will decline. But on the other side, we will generate novel memory B cells, which are better adapted to the new epitopes coming from -- with the Omicron variant.

Daina，在我看來，抗體的持久性主要是由初始抗體滴度驅動的。這就是體液隔室中發生的事情，包括血漿和粘膜表面。然後我們正在進行第二個反應，即記憶 B 細胞的持續成熟過程。正如我們在論文中所展示的那樣，在感染後，我們將直接產生記憶 B 細胞反應，由預先建立的記憶 B 細胞主導，但它們將是新的幼稚記憶 B 細胞加入該反應。但是這種幼稚的記憶B細胞將具有較少的突變和較低的親和力抗體。這將需要幾週，最多 3 個月，直到成熟。然後第二個加強劑可能必須真正產生針對新表位的高親和力抗體。這就是免疫學教給我們的，也是我們所期待的。這意味著抗體滴度會下降。但另一方面，我們將生成新的記憶 B 細胞，它們更適合來自 Omicron 變體的新表位。

Your next question comes from the line of Zhiqiang Shu from Berenberg.

您的下一個問題來自貝倫貝格的舒志強一行。

Congrats on the strong quarter. I'd like to ask about the capital allocation. You have EUR 19 billion on the balance sheet as of Q1. How do you think about spending that cash, in particular on the backdrop of the depressed biotech evaluation here thinking about [BD] and M&A opportunity. A quick one on the Claudin-18.2 mRNA program. Given where your history on that target, how do you see that approach differentiated from antibody approach?

祝賀強勁的季度。我想問一下資本配置。截至第一季度，您的資產負債表上有 190 億歐元。您如何看待花費這筆現金，特別是在考慮 [BD] 和併購機會的生物技術評估低迷的背景下。快速了解 Claudin-18.2 mRNA 程序。鑑於您在該目標上的歷史，您如何看待該方法與抗體方法的區別？

Thanks very much for the question. Let me start, and then I'll pass on to Ugur. We have reiterated the guidance, as you've seen, so EUR 13 billion to EUR 17 billion is the figure. After the first quarter, we feel very, very good about it. I mean the EUR 6.4 billion that we have reported in revenues and the profitability supports that we confirm that guidance. As stated at our year-end call, the main focus of our investments remain to invest in our research and development activities and going forward. But as you remember, we also have announced that we will invest EUR 1.5 billion in the share buyback program that we just had kick off very recently and that we also will give our shareholders that have stayed with us for a long time in the past. We gave shareholders EUR 500 million of a dividend payment in the course of this year.

非常感謝這個問題。讓我開始吧，然後我會轉到 Ugur。如您所見，我們重申了指導方針，因此數字為 130 億歐元至 170 億歐元。第一季度之後，我們對此感覺非常非常好。我的意思是我們報告的 64 億歐元的收入和盈利能力支持我們確認該指導。正如我們在年終電話會議上所說，我們投資的主要重點仍然是投資於我們的研發活動和未來。但正如您所記得的，我們還宣布將投資 15 億歐元用於我們剛剛啟動的股票回購計劃，我們還將向過去長期與我們在一起的股東提供資金。今年我們向股東支付了 5 億歐元的股息。

Going forward in terms of M&A activities, et cetera, we have, of course, looked and continuously looked into additions in terms of transactions that we can make, collaborations, all kinds of things that we are intending to proceed as we did in the past, but we can give you a closer guidance on where and when we will invest and how much, we got to see how things are evolving. But we feel good about the cash position. You've heard from me earlier that our cash position increased. We collected another EUR 5.2 billion mid of April. So we're in the ballpark of around about EUR 10 billion or above EUR 10 billion at this point in time. So we feel good about our cash position, and that gives us the opportunity to invest money in the years to come. Ugur? Ugur, do you want to take over the second question?

在併購活動等方面向前發展，當然，我們已經並不斷研究在我們可以進行的交易、合作以及我們打算像過去那樣進行的各種事情方面的補充，但我們可以為您提供更詳細的指導，讓您了解我們將在何時何地進行投資以及投資多少，我們必須了解情況如何發展。但我們對現金狀況感覺良好。你之前聽我說我們的現金頭寸增加了。我們在 4 月中旬又籌集了 52 億歐元。因此，我們目前處於大約 100 億歐元或超過 100 億歐元的範圍內。因此，我們對自己的現金狀況感覺良好，這使我們有機會在未來幾年進行投資。烏古爾？ Ugur，你要接手第二個問題嗎？

I can take over the second question, which was about our Claudin-18.2 RiboMab development. As you have already pointed out, we have experienced with clinical activity of an entire -- of Claudin-18.2 directed antibody and using mRNA to encode the entire body and circumvent the production, the need for producing the antibody as a recombinant protein comes with many opportunities, and we want to leverage these opportunities for using our RiboMab as a single-agent therapy, but also for combining it with other modalities.

我可以接手第二個問題，這是關於我們的 Claudin-18.2 RiboMab 開發的。正如您已經指出的那樣，我們已經體驗了整個 Claudin-18.2 定向抗體的臨床活性，並使用 mRNA 編碼整個身體並規避生產，因此需要將抗體作為重組蛋白生產機會，我們希望利用這些機會將我們的 RiboMab 用作單藥治療，同時也將其與其他模式相結合。

We will take 1 further question. And the last question comes from Ellie Merle from UBS.

我們將再回答 1 個問題。最後一個問題來自瑞銀的 Ellie Merle。

This is Sarah, on for Ellie. I guess in terms of BNT211 and sort of moving into later-stage development, what are you looking for? And what's your expectation that would make you confident in moving forward? And then on a larger scale, I guess, where do you see this fitting in, in terms of the other treatment options available and what line of therapy?

這是莎拉，為艾莉而戰。我想就 BNT211 和進入後期開發而言，你在尋找什麼？你的期望是什麼讓你對前進充滿信心？然後在更大的範圍內，我想，就其他可用的治療方案和治療方案而言，您認為這在哪裡適合？

With BNT211, our CAR-T cell therapy directed against Claudin-6, we are still in the dose escalation stage. So we have even not reached the highest dose we actually wanted to administer, yet we see already encouraging and promising clinical activity, in particular, in testicular cancer as well as in ovarian cancer. So what we want to do is to continue to collect the data and decide based on aggregate data, how to proceed. CAR-T cell therapy would be something which we would like to position in later lines of treatment. We think that in those indications in which we assess Claudin-6 CAR-T cells, namely advanced metastatic testicular cancer, ovarian cancer, endometrial cancer, rare cancers, such as sarcoma, there is considerable medical need and how exactly we will position will depend on the aggregate data we'll produce in dose escalation and dose expansion parts of this initial trial.

我們針對 Claudin-6 的 CAR-T 細胞療法 BNT211 仍處於劑量遞增階段。因此，我們甚至還沒有達到我們實際想要給藥的最高劑量，但我們已經看到了令人鼓舞和有希望的臨床活動，特別是在睾丸癌和卵巢癌中。所以我們要做的是繼續收集數據並根據匯總數據決定如何進行。 CAR-T 細胞療法將是我們希望在後期治療中定位的東西。我們認為，在我們評估 Claudin-6 CAR-T 細胞的那些適應症中，即晚期轉移性睾丸癌、卵巢癌、子宮內膜癌、罕見的癌症，如肉瘤，有相當大的醫療需求，我們將如何準確定位將取決於關於我們將在初始試驗的劑量遞增和劑量擴展部分產生的匯總數據。

I will now hand the call back Sylke for closing remarks.

我現在將回電 Sylke 以結束髮言。

Thank you for joining us today. We look forward to speaking with you in the future. Thank you, and bye-bye.

感謝您今天加入我們。我們期待在未來與您交談。謝謝你，再見。

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝你。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。