Galapagos NV (GLPG) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Galapagos first-quarter 2025 financial results and business update. (Operator Instructions) Please be advised, today's conference is being recorded.

您好，感謝您的支持。歡迎閱讀加拉巴哥 2025 年第一季財務業績和業務更新。（操作員指示）請注意，今天的會議正在錄音。

I'd now like to hand the conference over to your first speaker today, Glenn Schulman, Head of Investor Relations. Please go ahead.

現在，我想將會議交給今天的第一位發言者，投資者關係主管 Glenn Schulman。請繼續。

Thank you, operator, and thank you all for joining us for Galapagos' first quarter 2025 financial results and business update conference call. Last evening, we issued a press release outlining these results. This release, along with today's webcast presentation, can be found on the Galapagos' website.

謝謝接線員，也謝謝大家參加加拉巴哥 2025 年第一季財務業績和業務更新電話會議。昨晚，我們發布了一份新聞稿，概述了這些結果。此新聞稿以及今天的網路廣播演示可在加拉巴哥群島的網站上找到。

Before we begin, I would like to remind everyone that we will be making forward-looking statements. These forward-looking statements include remarks concerning future developments of our company and our pipeline and possible changes in the industry and competitive environment. Actual results may differ materially from those indicated by these statements and are accurate only as of the date of this recording, April 24, 2025.

在我們開始之前，我想提醒大家，我們將做出前瞻性的陳述。這些前瞻性陳述包括有關我們公司和我們的產品線的未來發展以及行業和競爭環境可能發生的變化的評論。實際結果可能與這些聲明所示的結果有重大差異，並且僅在本記錄日期（2025 年 4 月 24 日）準確。

Galapagos is not under any obligation to update statements regarding the future or to conform to these statements in relation to actual results unless required by law. Joining us on today's call from Galapagos' Senior Management team are Dr. Paul Stoffels, Chair and Chief Executive Officer; and Thad Huston, Chief Operating and Chief Financial Officer of the company. We are also joined by Dr. John Mellors, Head of Cell Therapy Discovery; Wulf Bocher, Head of Immunology; and Omotayo Fasan, Clinical Program Head, Oncology, and they'll be available during the Q&A session.

除非法律要求，否則加拉巴哥沒有義務更新有關未來的聲明或根據實際結果遵守這些聲明。參加今天電話會議的加拉巴哥高階管理團隊包括董事長兼執行長 Paul Stoffels 博士和公司首席營運長兼財務長 Thad Huston。我們也邀請了細胞療法研發負責人 John Mellors 博士、免疫學負責人 Wulf Bocher 和腫瘤學臨床計畫負責人 Omotayo Fasan，他們將在問答環節出席。

With that, let me now turn the call over to Paul.

說完這些，現在讓我把電話轉給保羅。

Thank you, Glenn. Before starting the Q1 financial update, I want to provide some color on the recently communicated executive leadership changes. We are very pleased with the appointment of Henry Gosebruch as the founding CEO of SpinCo. This is an important milestone in the planned separation of SpinCo as announced earlier this year.

謝謝你，格倫。在開始第一季財務更新之前，我想先介紹一下最近公佈的高階主管領導層變動。我們非常高興任命 Henry Gosebruch 為 SpinCo 的創始執行長。這是今年稍早宣布的 SpinCo 分離計劃中的一個重要里程碑。

Henry has deep experience in M&A, business development and capital allocation through his past roles as President and CEO of Neumora; Executive VP and Chief Strategy Officer at AbbVie; and M&A co-head at JPMorgan. We welcome Henry into his new role, and we look forward to introducing him to you in the coming weeks.

亨利曾擔任 Neumora 總裁兼執行長、AbbVie 執行副總裁兼首席策略長以及摩根大通併購聯席主管，在併購、業務發展和資本配置方面擁有豐富的經驗。我們歡迎亨利擔任新職務，並期待在未來幾週內向大家介紹他。

I would like to provide some color on my intent to retire from my role as CEO of Galapagos in the next 12 months, once the successor has been appointed. I want to underscore that I'm fully committed to supporting Galapagos as its CEO and Chair of the Board. Upon the CEO successor being appointed, my intention is to serve as Non-executive Chair of the Board of Galapagos, continue to provide strategic guidance and support.

我想說明我打算在未來 12 個月內從加拉巴哥執行長的職位上退休，一旦繼任者被任命。我想強調的是，身為加拉巴哥的執行長和董事會主席，我將全力支持該公司。在執行長繼任者被任命後，我打算擔任加拉巴哥董事會非執行主席，繼續提供策略指導和支援。

Galapagos has strong foundations in place to create value for all its stakeholders. We have built a strong company with top talent in Europe, the US and China as we continue to attract experts in cell therapy. Together, we are transforming Galapagos into a focused cell therapy company that is offering real hope to people facing cancer. I also want to thank Thad for his contribution to Galapagos as CFO and COO.

加拉巴哥群島擁有堅實的基礎，可以為所有利害關係人創造價值。隨著我們不斷吸引細胞治療領域的專家，我們已經建立了一家擁有歐洲、美國和中國頂尖人才的強大公司。我們共同努力，將加拉巴哥轉變為專注於細胞治療的公司，為癌症患者提供真正的希望。我還要感謝 Thad 作為財務長和營運長為加拉巴哥集團的貢獻。

He supported the transformation of Galapagos into the dedicated cell therapy company that we are today. He will remain with the company until August 1 to ensure a smooth transition and handover of responsibilities.

他支持加拉巴哥公司轉型成為如今的專業細胞治療公司。他將在公司任職至8月1日，以確保順利過渡和職責交接。

Let's now move to our Q1 financial results and business update. We continued to make meaningful progress advancing our clinical pipeline and expanding global access for our innovative manufacturing platform and decentralized manufacturing units or DMUs. As we announced in our press release last night, we are particularly pleased that we have dosed our first US patient in the ATALANTA-1 study of GLPG5101, where in combination with our ongoing European sites, we are evaluating our novel CD19 CAR-T candidate in 8 hematological malignancies with high unmet medical needs.

現在讓我們來看看第一季的財務表現和業務更新。我們繼續在推動臨床管線和擴大創新製造平台和分散製造單元或 DMU 的全球訪問方面取得有意義的進展。正如我們昨晚在新聞稿中宣布的那樣，我們特別高興的是，我們已經在 GLPG5101 的 ATALANTA-1 研究中為我們的第一位美國患者進行了給藥，結合我們正在進行的歐洲研究，我們正在對 8 種具有高度未滿足醫療需求的血液系統惡性腫瘤中的新型 CD19 CAR-T 候選藥物進行評估。

In addition, we completed enrollment of the indolent NHL cohort, added the diffuse large B-cell Richter transformation cohort and are in the process of adding the CLL cohort to the study. All other cohorts are open and enrolling. Importantly, we have selected MCL as a lead indication to take forward in a pivotal trial and are very optimistic for our prospects with this indication, which I will discuss in greater detail in a moment. We made great progress with our earlier-stage discovery programs and expect to initiate clinical development of a novel CAR-T candidate and to select at least one program for IND-enabling studies this year.

此外，我們完成了惰性 NHL 隊列的招募，增加了瀰漫大 B 細胞 Richter 轉化隊列，並且正在將 CLL 隊列添加到研究中。所有其他群組均已開放並開始招生。重要的是，我們選擇 MCL 作為關鍵試驗的主要適應症，並且對該適應症的前景非常樂觀，稍後我將更詳細地討論。我們在早期發現計畫上取得了巨大進展，並希望今年啟動新型 CAR-T 候選藥物的臨床開發並選擇至少一個計畫進行 IND 支持研究。

In 2026, the pipeline is expected to be further expanded with at least one additional next-generation program. Throughout the first quarter, we continued to make platform and process improvements to support pivotal studies and commercial readiness by expanding our decentralized manufacturing network in the US and Europe, giving patients direct access to our therapies and limiting logistical constraints.

2026 年，預計該管道將進一步擴展，至少增加一個下一代項目。在整個第一季度，我們透過擴大我們在美國和歐洲的分散製造網絡，繼續改進平台和流程，以支持關鍵研究和商業準備，讓患者直接獲得我們的治療並限制物流限制。

In collaboration with our partner, Adaptimmune, we also advanced the preparation to develop uza-cel for solid tumors, such as head and neck cancer, and plan to initiate proof-of-concept studies in 2026. Finally, we are working towards separation.

我們也與合作夥伴 Adaptimmune 合作，推進了針對頭頸癌等實體腫瘤的 uza-cel 的開發準備工作，並計劃於 2026 年啟動概念驗證研究。最後，我們正在努力實現分離。

And as I mentioned at the beginning of the call, we recently announced the appointment of the founding CEO of SpinCo, Mr. Henry Gosebruch. Thad will talk about SpinCo in greater detail later on today's call. We have as well advanced the two Phase 3 enabling studies in SLE and dermatomyositis with our TYK2 inhibitor, GLPG3667, and are actively seeking partners to acquire the program. Core to our strategy to build a leadership position in cell therapy in oncology is a decentralized manufacturing that was designed to overcome the limitations of current cell therapy manufacturing, which is centralized, and bears high cost burdens with longer production and delivery times that require cryopreserving cells and the need for bridging therapy.

正如我在電話會議開始時提到的，我們最近宣布任命 SpinCo 的創始執行長亨利·戈斯布魯赫 (Henry Gosebruch) 先生。薩德將在今天稍後的電話會議上更詳細地討論 SpinCo 的問題。我們也推進了 TYK2 抑制劑 GLPG3667 在 SLE 和皮肌炎方面的兩項 3 期支持性研究，並積極尋求合作夥伴來收購該計畫。我們的策略核心是建立在腫瘤細胞治療領域的領導地位，即分散式製造，旨在克服當前細胞治療製造的局限性，即集中式製造，成本負擔高，生產和交付時間較長，需要冷凍保存細胞並需要橋接治療。

A seven day vein-to-vein time is designed to provide fresh stem like cells, which we believe enhance the therapeutic profile by producing highly potent cells that are less exhausted, less toxic and persist longer. In addition to logistical advantages, our DMUs are designed to enable scalable and consistent products near the clinic. We believe this approach will be more cost-effective and provide greater access to these potentially life-saving cell therapies.

為期七天的靜脈到靜脈時間旨在提供新鮮的類幹細胞，我們相信透過產生消耗較少、毒性較小且持續時間較長的高效細胞，可以增強治療效果。除了物流優勢之外，我們的 DMU 還旨在實現診所附近可擴展且一致的產品。我們相信這種方法將更具成本效益，並為更多人提供可能挽救生命的細胞療法。

We are unlocking the broad-reaching potential of this decentralized cell therapy manufacturing platform as we advance our robust cell therapy pipeline. GLPG5101 is our most advanced CAR-T asset that is in clinical development in the US and Europe in the ATALANTA-1 Phase 1/2 clinical study in 8 hematological malignancies. As I mentioned earlier, we initiated dosing of patients in the US and expect enrollment to accelerate as more sites are activated.

隨著我們強大的細胞治療管道的推進，我們正在釋放這個分散的細胞治療製造平台的廣泛潛力。GLPG5101 是我們最先進的 CAR-T 資產，目前正在美國和歐洲的 ATALANTA-1 1/2 期臨床研究中針對 8 种血液系統惡性腫瘤進行臨床開發。正如我之前提到的，我們已開始在美國對患者進行給藥，預計隨著更多站點的啟動，患者招募速度將會加快。

We fully enrolled the indolent NHL cohort and expect to present these top line data at a medical meeting in mid '25. Enrollment continues well in the mantle cell lymphoma or MCL cohort, which we have selected as a lead indication to take into pivotal studies.

我們已全面招募惰性 NHL 患者，並有望在 25 年中期的醫學會議上展示這些最重要的數據。套細胞淋巴瘤或 MCL 隊列的招募工作進展順利，我們已將其選為關鍵研究的主要適應症。

Our plan is to start pivotal development in 2026 with an anticipated approval in 2028. We're progressing the enrollment of patients in the Phase 1/2 PAPILIO study of GLPG5301, or BCMA CAR T, as a treatment for relapsed refractory multiple myeloma. Here, we expect to have top line data in 2026. These data will direct our development plan for this product candidate. As noted earlier, we continue to build value by strengthening and advancing our early-stage pipeline of next-generation, multi-targeting armed cell therapies for hematological and solid tumors. We believe that the combination of fresh, fast and fit cells has the potential for transformative impact.

我們的計劃是於 2026 年開始關鍵開發，預計於 2028 年獲得批准。我們正在推進 GLPG5301 或 BCMA CAR T 的 1/2 期 PAPILIO 研究的患者招募，以治療復發難治性多發性骨髓瘤。在這裡，我們預計 2026 年將獲得頂線數據。這些數據將指導我們針對該產品候選物的開發計劃。如前所述，我們透過加強和推進針對血液腫瘤和實體腫瘤的下一代多靶點武裝細胞療法的早期研發管線來繼續創造價值。我們相信，新鮮、快速和健康的細胞組合具有產生變革性影響的潛力。

And we can see that from the data recently presented at ASH, which demonstrated a promising safety and efficacy profile for GLPG5101 in patients with mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma and diffuse large B-cell lymphoma. As of April 25, 2024, data cutoff, 49 patients received CD19 CAR-T cell therapy infusion, and safety and efficacy results were available for 45 patients and 42 patients, respectively.

我們可以從最近在 ASH 上公佈的數據中看到這一點，這些數據證明了 GLPG5101 對套細胞淋巴瘤、邊緣區淋巴瘤、濾泡性淋巴瘤和瀰漫大 B 細胞淋巴瘤患者俱有良好的安全性和有效性。截至 2024 年 4 月 25 日數據截止，49 名患者接受了 CD19 CAR-T 細胞療法輸注，其中 45 名患者和 42 名患者的安全性和有效性結果已獲得發表。

As you can see, we observed high overall response and complete response rates. Here, we show 100% of patients with relapsed/refractory mantle cell lymphoma, 95% of patients with relapsed/refractory follicle and marginal zone lymphoma and 54% of patients with relapsed/refractory DLBCL achieved a CR, Of evaluable patients achieving CR, 80% were MRD negative and remains in CR at the time of data cutoff.

如您所見，我們觀察到較高的整體回應率和完全回應率。這裡，我們顯示 100% 的複發/難治性套細胞淋巴瘤患者、95% 的複發/難治性濾泡和邊緣區淋巴瘤患者和 54% 的複發/難治性 DLBCL 患者達到了 CR，在達到 CR 的可評估患者中，80% 為 MRD 陰性並在數據截止時仍處於 CR 狀態。

Of note, strong and consistent in vivo CAR-T expansion levels and products consisting of stem-like early memory phenotype cells were observed in all doses tested, further supporting our innovative platform technology. And we are seeing these compelling results with very reassuring safety data with low levels of ICANS. This translates to less time in the ICU in hospital and more time at home with family.

值得注意的是，在所有測試劑量中都觀察到了強勁而一致的體內 CAR-T 擴增水平和由幹細胞樣早期記憶表型細胞組成的產品，進一步支持了我們創新的平台技術。我們看到了這些令人信服的結果，並且 ICANS 水平較低，安全數據非常可靠。這意味著在醫院加護病房度過的時間更少，有更多的時間在家陪伴家人。

Importantly, the eight2 hematological malignancies we are evaluating have created a EUR2 billion in peak sales potential in the US and the [EU5] alone. We are excited to move forward with MCL as a lead indication for pivotal studies. We made the determination based on a number of factors, including the high unmet medical need, strong initial data from this patient cohort and the fact that MCL accounts for approximately 6% of all NHL cases in the US. All combining make this an attractive lead indication for GLPG5101.

重要的是，我們正在評估的八種2种血液系統惡性腫瘤僅在美國和歐盟5國就創造了20億歐元的高峰銷售潛力。我們很高興能夠將 MCL 作為關鍵研究的主要適應症。我們根據多種因素做出了這一決定，包括未滿足的醫療需求量很大、來自該患者群體的強有力的初始數據以及 MCL 占美國所有 NHL 病例的約 6% 的事實。所有這些結合起來使得這成為 GLPG5101 的一個有吸引力的先導適應症。

Patient enrollment in this cohort of ATALANTA-1 is going well, and we expect to present new data from this cohort at a medical meeting in the second half of this year. Our strategic focus on MCL, supported by strong data and significant unmet medical need, positions us for pivotal development in 2026 and potential first approval in 2028, marking a major step forward to provide greater access to new medicines for patients in need.

ATALANTA-1 這一批病患入組進展順利，我們預計將在今年下半年的醫學會議上展示這群病患的最新數據。我們的策略重點是 MCL，這得益於強大的數據和龐大的未滿足醫療需求，使我們預計在 2026 年實現關鍵性發展，並在 2028 年獲得首次批准，這標誌著我們朝著為有需要的患者提供更多新藥管道邁出了重要一步。

Our mission is also grounded in providing greater access to these new medicines via our DMUs, which requires securing the capacity for clinical studies and commercial readiness. Our efforts here are supported by strong collaborations with Lonza for the Cocoon platform and Thermo Fisher Scientific for the development of an ultrarapid PCR sterility test together with miDiagnostics.

我們的使命還在於透過我們的 DMU 提供更多獲得這些新藥的機會，這需要確保臨床研究和商業準備的能力。我們的努力得到了與 Lonza 在 Cocoon 平台方面的密切合作以及與 Thermo Fisher Scientific 和 miDiagnostics 共同開發超快速 PCR 無菌測試的支持。

We are also expanding our network of DMU with our collaborations with Catalent for the New York, New Jersey and Pennsylvania area; Moffitt Cancer Center in Florida region; and NecstGen in the Benelux region. Collectively, these networks target nearly 250 million patients. Additional DMUs will be integrated into the company's network in the US and Europe to ensure sufficient capacity for clinical and future commercial supply in key regions.

我們還透過與 Catalent 合作擴大了 DMU 網絡，涉及紐約、新澤西和賓夕法尼亞地區；與莫菲特癌症中心合作擴大了佛羅裡達地區；與 NecstGen 合作擴大了比荷盧地區。這些網路總共覆蓋近 2.5 億名患者。更多的DMU將被整合到公司在美國和歐洲的網路中，以確保在關鍵地區有足夠的臨床和未來商業供應能力。

Most recently, and as announced in our press release, we have established operations in China that enable us to leverage our unique manufacturing platform and to accelerate the development and value creation of our next-generation cell therapy pipeline.

最近，正如我們在新聞稿中宣布的那樣，我們已在中國建立了業務，這使我們能夠利用我們獨特的製造平台，並加速我們下一代細胞治療管線的開發和價值創造。

With that overview of our cell therapy business, let me turn the call over to my colleague, Thad Huston, for a review of our financial and progress on the intended separation.

介紹完我們的細胞治療業務後，請允許我將電話轉給我的同事 Thad Huston，請他審查我們的財務狀況和預期分離的進展。

Thad?

薩德？

Thank you, Paul. Now turning to some of the financial highlights from the quarter, which as you would imagine, were impacted by our ongoing implementation of the restructuring and the SpinCo separation.

謝謝你，保羅。現在來看看本季的一些財務亮點，正如您所想像的，這些亮點受到了我們正在實施的重組和 SpinCo 分離的影響。

Total net revenues for the first quarter of 2025 were EUR75 million, which includes EUR14 million of supply revenues related to Jyseleca and EUR61 million in collaboration revenues. Increases to operating expenses were driven by our clinical expansion in oncology CAR-T in the build-out of our DMU network as well as EUR111 million of restructuring costs. These include severance costs, the early termination of collaborations, impairment on small molecule assets as well as deal costs related to planned separation. Looking to our balance sheet. We reported a cash balance of EUR3.3 billion at the end of the first quarter of 2025.

2025 年第一季的總淨收入為 7,500 萬歐元，其中包括與 Jyseleca 相關的 1,400 萬歐元供應收入和 6,100 萬歐元合作收入。營運費用的增加是由於我們在 DMU 網路建設中腫瘤 CAR-T 臨床擴張以及 1.11 億歐元的重組成本。這些包括遣散費、合作的提前終止、小分子資產的減損以及與計劃分離相關的交易成本。查看我們的資產負債表。我們報告稱，2025 年第一季末的現金餘額為 33 億歐元。

Important to note here is the timing difference of the effective payouts related to the reorganization, which is not represented in our cash balance. Upon separation, SpinCo will have approximately EUR2.45 billion to execute its strategy for transformative transactions. Following this planned transaction, Galapagos expects the normalized annual cash burn to be between EUR175 million and EUR225 million, excluding restructuring costs. Upon separation, Galapagos will have approximately EUR500 million in cash to accelerate the cell therapy pipeline and expects to have runway to fund operations to 2028. Turning now to the value proposition for Galapagos and SpinCo.

這裡要注意的是與重組相關的有效支出的時間差異，這並沒有反映在我們的現金餘額上。分離後，SpinCo 將擁有約 24.5 億歐元用於執行其轉型交易策略。在此次計畫交易完成後，Galapagos 預計正常年度現金消耗將在 1.75 億歐元至 2.25 億歐元之間（不包括重組成本）。分離後，Galapagos 將擁有約 5 億歐元現金來加速細胞治療產品線，並預計將有足夠的資金來維持 2028 年的營運。現在來談談加拉巴哥和 SpinCo 的價值主張。

We remain very excited by the opportunities we can create by separating Galapagos into two entities. Following the separation, Galapagos will be focused on accelerating the development of our flagship CD19 CAR-T program through our innovative decentralized manufacturing platform. As noted, our aim is to start pivotal development in 2026 and first approval in 2028. We will continue to build value by developing next-gen cell therapy programs in hematological and solid tumors.

我們對將加拉巴哥群島一分為二所能創造的機會感到非常興奮。分離之後，Galapagos 將專注於透過我們創新的分散製造平台加速我們旗艦 CD19 CAR-T 專案的開發。如上所述，我們的目標是在 2026 年開始關鍵開發，並在 2028 年獲得首次批准。我們將透過開發血液和實體腫瘤的下一代細胞治療方案來繼續創造價值。

Importantly, we will have the autonomy to partner our decentralized manufacturing platform and network as well as our differentiated cell therapy pipeline. We also streamlined the organization to realign our footprint and reduce cash burn. As I just mentioned, upon separation, Galapagos will have EUR500 million in cash to execute this focused strategy. Turning to the opportunities we have by creating SpinCo. We are excited that Henry has joined as the founding CEO of SpinCo. Henry will be hiring the remainder of SpinCo's leadership team in the coming period. The Board of SpinCo will comprise a majority of independent directors. SpinCo will be focusing on building a pipeline of innovative medicines through transformational transactions.

重要的是，我們將擁有自主權來合作我們的分散製造平台和網路以及我們的差異化細胞治療管道。我們還精簡了組織機構，以重新調整我們的佈局並減少現金消耗。正如我剛才提到的，分離後，加拉巴哥將擁有 5 億歐元現金來執行這項重點策略。談談我們透過創建 SpinCo 所獲得的機會。我們很高興亨利加入 SpinCo 並擔任創始執行長。亨利將在未來一段時間內招募 SpinCo 領導團隊的其他成員。SpinCo 董事會將由大多數獨立董事組成。SpinCo 將專注於透過轉型交易建立創新藥物管道。

The company will have sufficient resource to pursue high-quality assets, fund development and to invest in its portfolio, which is expected to focus on oncology, immunology and virology. If Gilead decides to opt in to SpinCo programs under the collaboration agreement, then SpinCo would be able to leverage Gilead's strong expertise and late-stage development and commercial capabilities in key therapeutic areas.

該公司將擁有充足的資源來追求優質資產、資助開發並投資其投資組合，預計將專注於腫瘤學、免疫學和病毒學。如果吉利德決定根據合作協議加入 SpinCo 項目，那麼 SpinCo 將能夠利用吉利德在關鍵治療領域的強大專業知識和後期開發及商業能力。

Importantly, all Galapagos shareholders will receive shares of SpinCo on a pro rata basis based on the number of Galapagos shares that they owned as the record date to be established.

重要的是，所有 Galapagos 股東將根據其在登記日期所持有的 Galapagos 股份數量按比例獲得 SpinCo 股份。

And with that, I'll hand it over to Paul, who will walk us through our near-term catalysts.

接下來，我將把時間交給保羅，他將向我們介紹我們的近期催化劑。

Thanks, Thad. As you can see on this slide, we have an exciting year ahead with the potential to achieve a number of value-driving catalysts. Our clinical programs have a number of key inflection points, including new top line data from the indolent NHL cohort to be presented at a medical conference in the second quarter of 2025, new data from the NCL cohort at the medical meeting in the second half of 2025 and an end of Phase 2 meeting for MCL that will align our pivotal trial design with global regulatory authorities and position us for pivotal development start in 2026.

謝謝，薩德。正如您在這張投影片上看到的，我們迎來了激動人心的一年，並有可能實現許多價值驅動催化劑。我們的臨床項目有許多關鍵的轉折點，包括將於 2025 年第二季度在醫學會議上展示的惰性 NHL 隊列的新頂線數據、將於 2025 年下半年在醫學會議上展示的 NCL 隊列的新數據以及 MCL 第 2 階段會議的結束，這將使我們的關鍵試驗設計與全球監管機構保持一致，並為我們在 2026 年開始的關鍵開發。

Advances with our innovative discovery engine will allow us to dose the first patients with our armed bispecific CAR-T candidate in 2025, and we will select at least one next-gen candidate to take forward to the clinic by year-end. For the planned separation of SpinCo, we expect to announce additional management and Board appointments and to obtain shareholder approval for the separation by mid-year.

我們創新發現引擎的進步將使我們能夠在 2025 年為首批患者提供我們的雙特異性 CAR-T 候選藥物，並且我們將在年底前選擇至少一名下一代候選藥物進入臨床。對於 SpinCo 的計劃分離，我們預計將在年中之前宣布更多管理層和董事會任命，並獲得股東對分離的批准。

In summary, 2025 is set to be a transformative year for Galapagos. With pivotal clinical milestones, groundbreaking advancements in our discovery engine and the strategic separation of SpinCo, we are well positioned to drive significant value for our stakeholders. We look forward to sharing our progress and achieving this ambitious goal. Thank you for your continued support and confidence in our vision.

總而言之，2025 年將成為加拉巴哥群島變革的一年。憑藉關鍵的臨床里程碑、發現引擎的突破性進步以及 SpinCo 的策略分離，我們已準備好為利害關係人創造巨大價值。我們期待分享我們的進展並實現這一雄心勃勃的目標。感謝您對我們願景的持續支持與信任。

Operator, we are ready to open the call to questions.

接線員，我們已準備好開始回答問題。

(Operator Instructions)

（操作員指示）

Thanks, Sara. While you compile the list, I just also want to mention that we have Valeria Cnossen, our Executive and General Counsel with us as well today for the Q&A period.

謝謝，薩拉。在您整理名單的同時，我還想提一下，我們的執行長兼總法律顧問 Valeria Cnossen 今天也與我們一起參加問答環節。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Hi there. Thanks for taking my questions, and Best wishes to Paul and Thad on the transition of the company and retirement, and congrats on the hiring of Henry for SpinCo. I guess now that it seems like there's a path that's even better defined for 5101, I was wondering if you could give us a better sense of your latest thinking on the registrational requirements in MCL.

你好呀。感謝您回答我的問題，並祝 Paul 和 Thad 的公司交接和退休一切順利，同時祝賀 Henry 受聘加入 SpinCo。我想現在看起來似乎有一條針對 5101 更明確的路徑，我想知道您是否可以讓我們更好地了解您對 MCL 註冊要求的最新想法。

What a pivotal could look like and what data you might need to show there? And then if you could also talk a little bit about your expectations for the time cushion between when this pivotal data could read out and your cash runway? Thanks.

關鍵數據是什麼樣的以及您可能需要在其中顯示哪些數據？然後，您是否可以稍微談談您對這個關鍵資料讀取和現金流量之間的時間緩衝的預期？謝謝。

Yeah. First, the choice of MCL is based on very good results. It's a very high unmet medical need, which we have been able to address with our CAR-T in a very positive way, very high cure rates as you have seen in the complete response rates, as you have seen in the slide, as well as very good safety data and it still in high unmet medical need with people who have a very high -- or a short life expectancy, and maybe our clinical lead, Tayo, may give some further comments on that on when and how we will get to a pivotal design.

是的。首先，選擇MCL是基於非常好的結果。這是一個非常大的未滿足的醫療需求，我們已經能夠透過 CAR-T 以非常積極的方式解決這個問題，正如您在幻燈片中看到的完全緩解率一樣，治愈率非常高，而且安全性數據也非常好，但對於預期壽命非常高或較短的人來說，它仍然存在很大的未滿足的醫療需求，也許我們的臨床負責人 Tayo 可能會發表很大的何時的評論。

Yes. This is Omotayo, the clinical program head for 5101. So MCL is the right choice for the first indication for 5101 because like Paul said, there is a high unmet medical need. The population we're targeting, the relapsed/refractory population, with non-CAR T therapy, have usually less than a 12 month event-free survival or progression-free survival with whatever therapy they get. So given this, there is a pathway for noble therapy like a CAR-T to pursue an indication using a single-arm trial design.

是的。我是 Omotayo，5101 臨床計畫負責人。因此，MCL 是 5101 的第一個適應症的正確選擇，因為正如保羅所說，存在著很高的未滿足的醫療需求。我們的目標族群是接受非 CAR T 療法的復發/難治性族群，無論接受何種療法，無事件存活期或無惡化存活期通常都少於 12 個月。因此，有鑑於此，存在一種途徑，讓像 CAR-T 這樣的高尚療法能夠採用單臂試驗設計來追求適應症。

But we also understand that with every single arm trial design, you need to have a confirmatory study lined up. And our initial thinking is that this would be a randomized controlled study to confirm the findings of the clinical benefit from the SAT.

但我們也明白，對於每一個單臂試驗設計，都需要進行確認性研究。我們最初的想法是，這將是一項隨機對照研究，以證實 SAT 的臨床益處的發現。

Yeah. And just to address, Brian, the question about the cash runway. We did intentionally align our capital allocation between SpinCo and Galapagos to address that pivotal readout and to align it with MCL. We say that the cash will take us into 2028, which is roughly the timing that we're anticipating for that.

是的。布萊恩，我只是想回答一下有關現金流的問題。我們確實有意調整了 SpinCo 和 Galapagos 之間的資本配置，以解決此關鍵讀數並使其與 MCL 保持一致。我們說這筆現金將幫助我們維持到 2028 年，這大致是我們預期的時間。

Thank you.

謝謝。

Phil Nadeau, TD Cowen.

菲爾·納多 (Phil Nadeau)，TD Cowen。

Good morning. Thanks for taking our question. Let us add our thanks to Paul and Thad for all your work over the years. A follow-up question to Brian's from us, and that's on manufacturing. Can you talk a bit more about your understanding or expectations for the manufacturing requirements that you'll need to file in the US and Europe? How well defined are those with the regulatory agencies? And is there more work to do to understand those requirements?

早安.感謝您回答我們的問題。讓我們向 Paul 和 Thad 多年來所做的一切工作表示感謝。我們對 Brian 的後續問題是關於製造業的。您能否詳細談談您對在美國和歐洲需要提交的製造要求的理解或期望？監管機構對這些內容的定義有多明確？還需要做更多工作來理解這些要求嗎？

And maybe a second part of the question would be how many DMUs do you think you would need in the US and Europe to fully satisfy the market? Thanks.

也許問題的第二部分是，您認為美國和歐洲需要多少輛 DMU 才能完全滿足市場需求？謝謝。

With regard to the requirements for the manufacturing process and equipment, we are in continuous discussion with the authorities. And each of the steps have been very well defined from where we are now, both with EMA and the FDA to starting pivotal, additional steps are taken on quality release, et cetera, and then what needs to be done by commercial.

關於生產流程和設備的要求，我們正在與相關部門持續溝通。從我們現在的情況來看，每個步驟都已非常明確地定義，無論是與 EMA 還是 FDA 一起開始關鍵步驟，還是在品質發布等方面採取額外步驟，然後是商業化需要做什麼。

And we have a whole development part in place for that with all the elements in place to be able to have our pivotal studies running as pre-commercial because we need to have the final formulation, final setup, and then confirming that with additional validation throughout our phase -- our pivotal study development.

我們已經準備好整個開發部分，其中所有要素都已到位，以便能夠讓我們的關鍵研究在商業化前運行，因為我們需要有最終的配方、最終的設置，然後在整個階段（即我們的關鍵研究開發階段）通過額外的驗證來確認這一點。

So that is very well understood. We have had multiple with the authorities, and we have a clear part for that with all in place to meet the 2028 date for commercial availability.

這是很好理解的。我們已經與相關部門進行了多次溝通，並明確表示將盡一切努力在 2028 年實現商業化。

Thanks, Phil, for the question. To address the point about the number of DMUs and sites, it has been evolving. I think initially, when we first acquired CellPoint, it was more about point of care, and we thought that, that would be like near the hospital. I think it's been evolving more towards decentralized manufacturing hubs, where -- again, like we recently signed with Moffitt, a collaboration to cover the Southeast. And so we think that we'll need fewer DMUs but have more of a regional coverage model.

謝謝菲爾提出這個問題。為了解決有關 DMU 和站點數量的問題，它一直在不斷發展。我認為最初，當我們第一次收購 CellPoint 時，更多的是關注護理點，我們認為那就像醫院附近一樣。我認為它正在向分散的製造中心發展，就像我們最近與莫菲特簽署的一項覆蓋東南部的合作協議一樣。因此我們認為我們需要更少的 DMU，但需要更多的區域覆蓋模型。

And that's still under development for commercial, but we're still in the clinical phase at this point. But as it evolves, I think it will be more regional. And then (multiple speakers) also having regional hubs as well covering the Benelux, of course, UK and key markets throughout Europe.

目前該產品仍處於商業開發階段，但我們仍處於臨床階段。但隨著它的發展，我認為它將更加區域化。然後（多位發言者）還設有區域中心，涵蓋比荷盧三國、英國和整個歐洲的主要市場。

Great, thank you.

太好了，謝謝。

Sebastiaan van der Schoot, Van Lanschot Kempen.

塞巴斯蒂安范德斯庫特，範蘭斯霍特肯彭。

Hey, good morning, guys. Thank you for taking my questions and sad to see Paul and Thad go. I think that you mentioned partnership opportunity for Galapagos after the split has been finalized. Are you also interested in partnering on the Cocoon approach with other partners for the development of cell therapies? And if so, can you describe how such partnerships would look like? And then maybe can you also provide some insight on the focus of the next-generation CAR-T? Thank you.

嘿，大家早安。感謝您回答我的問題，我很遺憾看到保羅和薩德離開。我認為您提到了分拆完成後加拉巴哥群島的合作機會。您是否也有興趣與其他合作夥伴合作採用 Cocoon 方法開發細胞療法？如果是的話，您能描述一下這種合作關係是什麼樣的嗎？那麼，您能否就下一代 CAR-T 的重點提供一些見解？謝謝。

Well, Sebastiaan, first, I want to say, I'm not yet gone. I've committed to stay for the next 12 months to make sure at first as CEO and then continue as chair. So I will stay with Galapagos for the long time. So that is -- that was -- that's my mission. On -- yeah, the partnerships, yeah, we will be -- we have a lot of interest in people who look at our manufacturing platform to be participating in that.

好吧，塞巴斯蒂安，首先我想說，我還沒離開。我承諾留任未來 12 個月，首先擔任首席執行官，然後繼續擔任董事長。所以我會長期留在加拉巴哥群島。這就是──這就是──我的使命。是的，關於合作夥伴關係，是的，我們會的——我們對關注我們製造平台並願意參與其中的人們非常感興趣。

The first collaboration we did was with Adaptimmune, where we saw that -- where we actively studied uza-cel in the Cocoon and we're able to show that we could make the TCRT also in seven days with very good quality cells. That enables us now to bring that into the clinic in '26 with a study most likely in head and neck. That is the goal.

我們的第一次合作是與 Adaptimmune 合作，我們發現——我們在 Cocoon 中積極研究了 uza-cel，並且我們能夠證明我們也可以在七天內用非常優質的細胞製造 TCRT。這使我們能夠在 1926 年將其帶入臨床，最有可能的研究是頭部和頸部。這就是目標。

More interest is there. But at the moment, we have a single focus on making sure we bring our own platform and our own products forward to commercial. Eventually, yes, there will be opportunities to partner on the platform itself.

還有更多有趣的事。但目前，我們唯一的重點是確保將我們自己的平台和產品推向商業化。最終，是的，平台上將會有合作的機會。

The DMU is a very -- it's an exceptional unique approach, bringing CAR-Ts close to people and also the ability to bring them global, including Asia, South America, all the rest of the world is accessible by this principle. So we'll foresee definitely collaborations as we go forward, but with a focus on making sure our own products reach the market first.

DMU 是一種非常獨特的方法，它讓 CAR-T 細胞更貼近人們，並且能夠透過這項原則將它們推向全球，包括亞洲、南美洲和世界其他地區。因此，我們肯定會預見未來的合作，但重點是確保我們自己的產品首先進入市場。

Yeah. I think it's a really exciting time for us. So as we do the separation to have this platform, as Paul mentioned, develop our own pipeline but also to develop next-generation assets, which John can talk more about.

是的。我認為這對我們來說是一個非常令人興奮的時刻。因此，正如保羅所提到的那樣，當我們分離出這個平台時，我們不僅開發自己的管道，還開發下一代資產，約翰可以詳細談談這一點。

John?

約翰？

Yeah, Hi, John Mellors, Head of Discovery. I'm happy to talk about our next-generation assets. They will address high unmet medical need in both liquid and solid tumors. The approach is to take validated targets and combine them, potentially with new targets through multi-targeting strategy and also arming the cells to expand and persist and not be inhibited by the tumor microenvironment and to engage the endogenous non-CAR-T immune system to attack the tumor.

是的，你好，我是探索部門主管約翰‧梅勒斯 (John Mellors)。我很高興談論我們的下一代資產。它們將解決液體腫瘤和實體腫瘤中未滿足的醫療需求。此方法是透過多標靶策略將已驗證的標靶與新標靶結合，同時武裝細胞以使其擴增和持續存在且不受腫瘤微環境的抑制，並利用內源性非 CAR-T 免疫系統攻擊腫瘤。

And we're targeting non-Hodgkin's lymphoma that is refractory even after first generation CAR-T therapy, but we'll move into earlier lines of therapy as data emerge, particularly in DLBCL, where there's high unmet medical need, and also refractory multiple myeloma after BCMA bispecific or CAR-T therapy.

我們的目標是即使經過第一代 CAR-T 療法治療後仍具有抗藥性的非何杰金氏淋巴瘤，但隨著數據的出現，我們將進入更早期的治療領域，特別是對於存在大量未滿足醫療需求的 DLBCL，以及經過 BCMA 雙特異性或 CAR-T 療法治療後的抗藥性多發性骨髓瘤。

The largest unmet medical need is in solid tumors, and we have identified three programs to hit various forms of lung cancer and gynecologic cancer. And as was mentioned earlier, we'll nominate our first candidate for IND this year for hematologic cancer, which will be advanced over existing therapies, and we will move into early clinical development through our recently established headquarters in Shanghai, China. Thank you.

最大的未滿足醫療需求是實體腫瘤，我們已經確定了三個項目來針對各種形式的肺癌和婦科癌症。如同前面所提到的，我們今年將提名第一位血液癌症 IND 候選藥物，該藥物將比現有療法更先進，我們將透過最近在中國上海設立的總部進入早期臨床開發階段。謝謝。

Thank you.

謝謝。

Manos Mastorakis, Deutsche Bank.

馬諾斯‧馬斯托拉基斯，德意志銀行。

Hi, thank you so much for taking my question. So a little bit more color on the M&A strategy, the modalities, the collaboration versus straight out acquisitions would be much appreciated as well as whether SpinCo will be completely independent in the development of its new portfolio or whether GLPG resources will be tapped into? And what are the sort of time lines for starting to see some of those deals executed by SpinCo?

你好，非常感謝您回答我的問題。因此，如果能更詳細地介紹一下併購策略、方式、合作與直接收購，以及 SpinCo 是否會完全獨立地開發其新的投資組合，或者是否會利用 GLPG 資源，我們將非常感激。那麼 SpinCo 執行這些交易的具體時間表是怎麼樣的呢？

Thank you, Manos, for the question. Yes, SpinCo will be an independent company and obviously, now with having -- Henry is the Head of the -- the CEO, who'll really focus on bringing in and acquiring new assets. And so it's not limited to particular area that's of strategic interest to Galapagos.

謝謝 Manos 提出的問題。是的，SpinCo 將成為一家獨立公司，顯然，現在有了——亨利是首席執行官，他將真正專注於引進和收購新資產。因此，它並不局限於對加拉巴哥群島具有戰略利益的特定區域。

It's really up to Henry and the independent Board and management team to do those deals. We will provide, obviously, the support to initially set up the SpinCo and the entity and provide any support like IT or finance or just those kind of general G&A support. But yeah, they'll be an independent team.

這些交易其實取決於亨利和獨立董事會及管理團隊。顯然，我們將為 SpinCo 和實體的初步設立提供支持，並提供 IT 或財務等任何支持，或僅僅是那些一般的 G&A 支持。但是是的，他們將是一支獨立的球隊。

For the timing of the first deal, as we are approaching midyear, most likely, there will be no deal done before the spin is actually done. So that is -- but it will be very active on -- much activity ongoing to prepare for potential opportunities.

對於第一筆交易的時間，由於我們即將進入年中，因此很可能在分拆實際完成之前不會達成任何交易。所以，我們會非常積極地進行許多活動，為潛在的機會做好準備。

Faisal Khurshid, Leerink Partners.

Faisal Khurshid，Leerink Partners。

Hi everyone, thanks for taking the question. Just -- can you provide some context on expectations for the MCL data update coming in the second half of this year? Curious if you can kind of say anything on like numbers of patients and extent a follow-up compared to the data that we saw last year?

大家好，感謝你們提出這個問題。只是——您能否提供一些有關今年下半年 MCL 數據更新的預期背景？好奇您是否可以談談與我們去年看到的數據相比，患者數量和追蹤範圍如何？

Tayo, can you give a short update on what to be expected?

Tayo，您能簡單介紹一下預期情況嗎？

Yeah. So last ASH, ASH 2024, we had 8 MCL patients in that data set. That's from April 2024, exactly a year ago. We have continued to enroll and the numbers have increased, and we will be updating and releasing data second half of this year.

是的。因此，在上一次 ASH（ASH 2024）中，我們的資料集中有 8 名 MCL 患者。那是 2024 年 4 月，正好是一年前。我們的招生人數持續增加，我們將在今年下半年更新並發布數據。

Yeah. Can you say anything on how many patients and how much follow-up?

是的。您能透露一下有多少名患者以及進行了多少次追蹤嗎？

So the median follow-up at ASH for that cohort was about three to four months. And like I said, will be at least 1 year on. So that's about the follow-up you will expect. The numbers are more than we've reported and we're not ready to disclose at this time.

因此，ASH 對該族群的中位追蹤時間約為三至四個月。正如我所說的，至少還需要一年的時間。這就是您所期望的後續行動。實際數字比我們報告的要多，目前我們還沒有準備好揭露。

Well, let me add in general, what we are doing is in the eight indications which we are studying, we have a Phase 1/2 -- Phase 1 part and a Phase 2 part and the Phase 1 part in the dose finding, the Phase 2 part in the expansion cohorts. And we typically go up to around 20 patients, might be more, but that is the range we will report on multiple of our indications in the future.

好吧，讓我總體補充一下，我們正在研究的 8 個適應症中，有 1/2 期——1 期部分和 2 期部分，1 期部分用於劑量探索，2 期部分用於擴展隊列。我們通常會治療大約 20 名患者，也可能更多，但這是我們未來針對多種適應症報告的範圍。

So you have seen the list on the slides on the different indications. All the indications are recruiting except for the Richter transformation in CLL, which still need to kick off. RT, Richter transformation is ready to go. CLL, the protocol is being finalized with the authorities. And hopefully, in the next few months, we'll be able to recruit there too.

您已經在幻燈片上看到了不同適應症的清單。除了 CLL 中的里氏轉變仍需啟動外，所有跡像都在招募中。RT，里氏變換已準備就緒。CLL，該協議正在與當局敲定。希望在接下來的幾個月裡，我們也能在那裡招募。

So it's a very active program. It will -- but each of the indications will be going up to a certain number in the range of 20 to confirm efficacy and safety.

所以這是一個非常活躍的項目。確實如此——但每種適應症的檢測數量都會達到 20 左右的一定值，以確認其有效性和安全性。

Got it. That's very helpful, Paul. And then if I can just ask a follow-up here. What is the target profile that you think you need to achieve in MCL to kind of differentiate from the two approved CAR-T options?

知道了。這非常有幫助，保羅。然後我是否可以在這裡詢問後續問題。您認為需要在 MCL 中實現什麼樣的目標才能與兩種已批准的 CAR-T 選項區分開來？

Tayo?

泰約？

Yeah. So the two CAR-Ts you referenced, one of them is known for its efficacy, the other for its safety. We believe our profile will match -- should match the efficacy and the safety, as I just explained. So we think we will merge the best of both worlds.

是的。所以您提到的兩種 CAR-T，一種以其功效而聞名，另一種以其安全性而聞名。我們相信我們的概況將匹配 - 應該匹配功效和安全性，正如我剛才解釋的那樣。因此我們認為我們將融合兩全其美的優勢。

Well, in addition to that, the opportunity to have a product which can -- a cell therapy product, which can be administered in a seven day vein to vein. So people with life expectancy, even up to -- with one month, you still can get therapy. And that is a very important feature for what we see now in the clinics. They have relapsed patients who come back to the clinic with relapsed refractory mantle cell lymphoma with very short life expectancies, and those are specifically people where our product can be very, very differentiated to still give a solution for that patient.

嗯，除此之外，還有機會獲得一種產品——一種細胞治療產品，可以在七天內進行靜脈注射。因此，預期壽命即使只剩下一個月的人，仍然可以接受治療。這是我們目前在診所看到的一個非常重要的特徵。有復發患者回到診所，患有復發性難治性套細胞淋巴瘤，預期壽命非常短，而對於這些患者，我們的產品可以進行非常非常差異化的治療，仍然可以為他們提供解決方案。

And I will just add on to what Paul said. One of the things we know from prior CAR-T data in MCL is that as a percentage of patients drop out between leukapheresis and infusion. The strength of our platform is that within seven days, that number is much reduced. So we believe that this is additional value 5101 will be able to bring to this high unmet medical need.

我只是想補充保羅所說的話。我們從 MCL 中的先前 CAR-T 數據中了解到的一件事是，有一定比例的患者在白血球分離術和輸注之間退出治療。我們平台的優勢在於，在七天內，這個數字就會大大減少。因此，我們相信 5101 將能夠為這項尚未滿足的醫療需求帶來額外的價值。

Yeah.

是的。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

Hi, Congrats on the progress. Just a couple of follow-ups. I guess, first, maybe just in reference to expanding the collaboration agreements in the US, just curious if kind of new partners are indicating that it's supply that's an issue for them or that they're interested in expanding for CAR-Ts at their centers? Or is it the efficacy of the program that's resonating more?

你好，祝賀你取得進展。僅需幾個後續行動。我想，首先，也許只是關於擴大在美國的合作協議，只是好奇是否有新的合作夥伴表示供應對他們來說是一個問題，或者他們有興趣在他們的中心擴大 CAR-T 業務？還是該計劃的有效性更能引起共鳴？

And then just on SpinCo, we've gotten the question. Is there any chance, given Henry's recent background, that neurology could be an area of focus going forward?

然後就在 SpinCo 上，我們得到了這個問題。考慮到亨利最近的情況，神經病學是否有可能成為未來關注的領域？

Yeah. So I think on the separation, I mean, clearly, we see a lot of interest in our platform with cell therapy, the decentralized manufacturing. But I think where it gets really exciting is what Paul mentioned with Adaptimmune, when we test cells on the Cocoon in seven days, we see better cell quality and better outcomes. And so there has been interest, I think, post separation, for us to partner with many different types of companies, both big and small, depending on whether they need a manufacturing platform or whether they want to see even better efficacy for their products that's in their pipeline.

是的。所以我認為，關於分離，我的意思是，很明顯，我們看到了人們對我們的細胞療法平台和分散製造的濃厚興趣。但我認為真正令人興奮的是保羅在談到 Adaptimmune 時提到的，當我們在七天內對 Cocoon 上的細胞進行測試時，我們看到了更好的細胞質量和更好的結果。因此，我認為，分離之後，我們有興趣與許多不同類型的公司（無論大小）合作，這取決於他們是否需要製造平台，或者他們是否希望看到他們正在研發的產品具有更好的功效。

And I think related to the SpinCo, it's -- I think our areas of interest that we've outlined has been oncology, immunology and virology which, again, were areas of interest for Gilead. But I think it's always possible depending on the deal.

我認為與 SpinCo 相關——我認為我們所概述的興趣領域是腫瘤學、免疫學和病毒學，這些也是吉利德感興趣的領域。但我認為這總是有可能的，這取決於交易。

With regard to the partnerships on the DMUs and hospitals and interest, there is significant interest. We are building up DMU by DMU as we need to validate and cross-validate with these -- the production as biological production sites. And sometimes that takes certain times, and that's where we are building up very steadily. But in between now and the year-end, we'll have multiple of the DMUs up and running, preparing for the pivotal. So that is ongoing.

關於 DMU 和醫院的合作關係和興趣，人們有著濃厚的興趣。我們正在逐一建構 DMU，因為我們需要驗證和交叉驗證這些——作為生物生產基地的生產。有時這需要一定的時間，而這正是我們正在穩步前進的地方。但從現在到年底，我們將啟動並運行多個 DMU，為關鍵時刻做好準備。這仍在進行中。

Lots of interest on hospitals, and we select the DMUs where we can manufacturing close in regions with access to multiple large hospitals and within a few hours’ drive range so that we can deliver the fresh cells in the same day.

人們對醫院非常感興趣，我們選擇在靠近多家大型醫院且在幾個小時車程範圍內的地區進行製造的 DMU，以便我們可以在同一天交付新鮮細胞。

Cells come from our manufacturing system in the morning. They need a few hours for quality release and they typically are administered in the afternoon to patients. So that is the way we operate in close to large cities with multiple hospitals today.

細胞在早上從我們的製造系統出來。它們需要幾個小時才能達到品質釋放，並且通常在下午給患者使用。這就是我們目前在靠近大城市且擁有多家醫院的場所開展業務的方式。

Thank you.

謝謝。

Jacob Mekhael, KBC Securities.

Jacob Mekhael，KBC 證券。

Hi there, and thanks for taking my question. With the recent changes happening at the FDA, how do you think this could impact how the agency looks at point of care CAR-T? And could there be a change to how open they are to new ways and manufacturing and delivering cell therapies now that they're working with less people?

您好，感謝您回答我的問題。隨著 FDA 最近的變化，您認為這會如何影響該機構對即時護理 CAR-T 的看法？現在他們與更少的人合作，他們對新方法、製造和提供細胞療法的開放程度是否會改變？

Well, that's to be expected. I think, well, to be expected, to be looked for on what the change is going to be. But one thing I can say, if we work on and we have the recent experience in the past few weeks with the FDA, working on a very high unmet medical need still gets priority, still gets support, still gets the help of the people at the FDA.

嗯，這是意料之中的事。我認為，嗯，這是可以預料的，可以期待會發生什麼變化。但有一件事我可以說，如果我們繼續努力，並且有過去幾週與 FDA 合作的經驗，那麼解決非常高的未滿足的醫療需求仍然會得到優先考慮，仍然會得到支持，仍然會得到 FDA 人員的幫助。

But even more I was at the Rome Cell and Gene Therapy Conference last week in Rome and the senior regulators from Europe and the UK were there. And they see this also as an opportunity now Europe and the UK to stand up and drive the innovation. And I think we'll get support all over the world, especially because you bring a product for a very high unmet medical need, which can help many patients.

但更重要的是，我上週參加了在羅馬舉行的羅馬細胞和基因治療會議，來自歐洲和英國的高級監管機構也出席了會議。他們認為這也為歐洲和英國站起來推動創新提供了機會。我認為我們會得到全世界的支持，特別是因為你們的產品能夠滿足非常大的未滿足的醫療需求，可以幫助很多病人。

So I expect, yes, there might be some hiccups. But so far, we have not yet seen that.

所以我預計，是的，可能會出現一些小問題。但到目前為止，我們還沒有看到這種情況。

Okay, thank you very much.

好的，非常感謝。

Chi Fong, Bank of America.

美國銀行的 Chi Fong。

This is Chi, on for Jason Gerberry at Bank of America. I have a question on 5301. So [the few] currently has a hypothesis that Parkinsonism is a class effect and not the molecule or construct-specific effect and that you can minimize Parkinsonism by prophylactic steroid treatment. I'm curious what's your view on that? And can you remind us of what the mitigation strategy you have implemented in the amended Phase 1 protocol?

我是 Chi，代表美國銀行的 Jason Gerberry。我對 5301 有疑問。因此，[少數人]目前有一個假設，即帕金森氏症是一種類別效應，而不是分子或結構特異性效應，並且可以透過預防性類固醇治療來最大限度地減少帕金森氏症。我很好奇您對此有何看法？您能否提醒我們您在修訂後的第一階段協議中實施了哪些緩解策略？

Are you giving patients prophylactic dexamethasone or a similar approach? And have you seen any Parkinsonian case since you have resumed the study? Thanks so much.

您是否為患者提供預防性地塞米鬆或類似治療方法？自從您恢復研究以來，您是否曾看過帕金森氏症病例？非常感謝。

So Tayo or John, can you step in here?

那麼 Tayo 或 John，你們可以介入嗎？

Yeah. So I'll go and then maybe John can add as well. The mitigation strategies we put in place are strategies that have been published in the literature. When the Parkinsonism associated with BCMA therapy first hit the headlines, I think this gave us a surprise. And when the data was reviewed, certain risk factors were identified, such as patients with high tumor volume was a risk factor and patients with rapidly rising lymphocyte count.

是的。所以我會去，然後也許約翰也可以補充。我們實施的緩解策略是已在文獻中發表的策略。當與 BCMA 療法相關的帕金森氏症首次成為頭條新聞時，我認為這讓我們感到驚訝。當審查數據時，發現了某些風險因素，例如腫瘤體積大的患者是一個風險因素，淋巴細胞計數迅速上升的患者也是一個風險因素。

So what we've done in our protocol is to try to mitigate at least two of these or both of these issues, and we have elements in the protocol to protect patients. And since restarting the study, we have been able to manage all the patients that have been enrolled, and haven't seen any further occurrences.

因此，我們在協議中所做的就是嘗試緩解其中至少兩個或兩個問題，並且我們在協議中製定了保護患者的要素。自從重新開始研究以來，我們已經能夠管理所有已登記的患者，並且沒有看到任何進一步的事件發生。

So as we said earlier, one comment more is that we are still in the Phase 1/2 study phase, closing on the dose finding and then we'll further expand and we'll have -- we'll be able to report on this study in '26 because, yes, it takes time and the spacing of the dose finding and the safety event we had, we got some delay, but now we are back on track, and we'll look forward to that. Based on those data, we'll decide what development part we take for our BCMA product. Thank you.

因此，正如我們之前所說，還有一條評論是，我們仍處於第 1/2 階段研究階段，即將確定劑量，然後我們將進一步擴大，我們將能夠在 26 年報告這項研究，因為是的，這需要時間，而且劑量確定和安全事件之間的間隔也有些延遲，但現在我們已經回到正軌，我們對此充滿期待。根據這些數據，我們將決定對 BCMA 產品採取哪些開發部分。謝謝。

Great, thank you.

太好了，謝謝。

(Operator Instructions)

（操作員指示）

Sean McCutcheon, Raymond James.

肖恩麥卡琴、雷蒙德詹姆斯。

Hi, good morning, team. Congrats on the progress. This is [Yang] on for Sean from Raymond James. We have a question regarding the US clinical trial, especially for ATALANTA. Now you have dosed your first patient, and could you provide some color on the degree of availability you have seen from a per patient basis or a per site basis, especially given your previous experience that for some patients, the product may be below the target dose.

嗨，早上好，團隊。恭喜你取得進展。我是 Raymond James 的 Sean [Yang]。我們有一個關於美國臨床試驗的問題，特別是關於 ATALANTA 的臨床試驗。現在您已經為第一位患者進行了給藥，您能否提供一些關於從每個患者或每個站點的角度來看待的可用性程度的詳細信息，特別是考慮到您之前的經驗，對於某些患者，產品可能低於目標劑量。

What's your thinking and strategy for the protocol action in that case? Thank you.

在這種情況下，您對協議行動的想法和策略是什麼？謝謝。

Tayo?

泰約？

Yeah. So specifically, we just began enrolling patients in the US, if your question was about the patients in the US versus Europe. So we're still gathering data, and so I can't answer that question specifically. However, what I can say in general terms is that even in cases where the doses may not be the dose as intended, when those patients have been infused, we have seen encouraging safety data and efficacy data.

是的。具體來說，如果您的問題是關於美國與歐洲的患者，我們剛開始在美國招募患者。所以我們仍在收集數據，所以我無法具體回答這個問題。然而，我可以概括地說，即使在劑量可能不是預期劑量的情況下，當這些患者輸注後，我們已經看到了令人鼓舞的安全數據和療效數據。

And an investigation and process improvements were put in place. And since then, the dosing has been more consistent at the desired dose.

並進行了調查並改進了流程。從那時起，劑量就更穩定地保持在所需劑量。

Okay. Maybe I can do a follow-up for the ATALANTA-1. We noticed that you did not mention DLBCL. Could you give us your thoughts on this cohort and what you're thinking for defining the go-forward dose?

好的。也許我可以對 ATALANTA-1 進行跟進。我們注意到您沒有提到 DLBCL。您能否告訴我們您對這個群體的看法以及您對定義後續劑量的想法？

Tayo?

泰約？

Yeah. Okay. So ATALANTA has seven cohorts right now. And like Paul mentioned earlier, we're adding an eighth cohort, chronic lymphocytic leukemia. MCL is the first cohort that's going forth to pivotal.

是的。好的。因此，亞特蘭大目前有七個隊伍。正如保羅之前提到的，我們正在增加第八個隊列，即慢性淋巴細胞白血病。MCL 是第一批邁向關鍵階段的人。

And the other cohorts continue to enroll, we continue to gather data, analyze the data. And as the data matures, we intend to progress those cohorts to pivotal as well. DLBCL is one of those cohorts, it's still open, and it's enrolling patients.

隨著其他群體繼續報名，我們繼續收集數據並分析數據。隨著數據的成熟，我們打算將這些群體推進到關鍵階段。DLBCL 就是其中之一，它仍然開放，並且正在招募病患。

Okay, Thanks for the update.

好的，謝謝更新。

David Seynnaeve, Degroof Petercam.

大衛·塞奈夫，德格羅夫·彼得卡姆。

Hi, good afternoon. Just wondering at the speed it's going now, when you expect the PAPILIO-1 patient enrollment to be completed and based around if it's going to be more likely H1 or H2 2026 when you share the top line results or at least when you expect to be able to provide more detailed guidance on that? Thank you.

嗨，下午好。只是想知道，以現在的進展速度，您預計 PAPILIO-1 患者招募何時完成，以及當您分享頂線結果時，它更有可能在 2026 年上半年還是下半年完成，或者至少您預計何時能夠就此提供更詳細的指導？謝謝。

I think at the moment, we are still, as I said, recruiting in the Phase 1 part of that. Soon, the Phase 2 will start. We can't give further guidance on when we'll be able to report top line data, but it will be '26, and in one of the next calls, we'll provide more detail on that, where we will land in the course of 2026.

我認為目前我們仍在進行第一階段的招募，正如我所說的。很快，第二階段即將啟動。我們無法就何時能夠報告頂線數據提供進一步的指導，但那將是 26 年，在接下來的一次電話會議中，我們將提供更多有關該數據的細節，以及我們將在 2026 年實現的目標。

Okay. Thank you.

好的。謝謝。

Okay, thank you. And there are no further questions at this time. So I will now hand the conference back to Glenn Schulman for any closing comments.

好的，謝謝。目前沒有其他問題。現在我將會議交還給 Glenn Schulman，請他發表最後評論。

Thanks, Sara, and thank you, everyone, for joining us today on our first quarter 2025 results conference call. On behalf of the team, I want to thank you for your attention. Also to let you know that we will be attending -- the team will be presenting at the Jefferies conference coming up in June, and we'll be reporting our next webcast of first half financial results, July 23, followed by the webcast on July 24. So I hope everyone has a great day and be well. Thank you.

謝謝，薩拉，也謝謝大家今天參加我們的 2025 年第一季業績電話會議。我代表團隊感謝您的關注。另外，我們也會通知您，我們將參加 6 月份舉行的 Jefferies 會議，並且我們將於 7 月 23 日報告下一次上半年財務業績網絡直播，隨後於 7 月 24 日進行網絡直播。我希望大家度過愉快的一天，一切安好。謝謝。

Thank you. This concludes today's conference call. Thank you for participating, and you may now disconnect. Speakers, please stand by.

謝謝。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了。發言者請稍候。