ADC Therapeutics SA (ADCT) 2025 Q2 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics SA ADCT Q2 2025 Earnings Conference Call. (Operator Instructions) This call is being recorded on Tuesday, August 12, 2025.

女士們、先生們，早安，歡迎參加 ADC Therapeutics SA ADCT 2025 年第二季財報電話會議。（操作員指示）此通話於 2025 年 8 月 12 日星期二錄製。

I will now turn the call over to Nicole Riley, Head of Investor Relations and Corporate Communications for ADC Therapeutics. Nicole, please go ahead.

現在我將把電話轉給 ADC Therapeutics 投資者關係和企業傳播主管 Nicole Riley。妮可，請繼續。

Thank you, operator. Today, we issued a press release announcing our second quarter 2025 financial results and business updates. This release and the slides we will use in today's presentation are available on the Investors section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance and recent business highlights. Our Chief Medical Officer, Mohammad Zaki, who will discuss our clinical programs and updates; followed by our Chief Financial Officer, Pepe Carmona, who will review our second quarter 2025 financial results. We will then open the call to questions.

謝謝您，接線生。今天，我們發布了一份新聞稿，宣布了我們 2025 年第二季的財務業績和業務更新。此新聞稿和我們將在今天的簡報中使用的幻燈片可在 ADC Therapeutics 網站的投資者部分找到。我們的執行長 Ameet Mallik 也參加了今天的電話會議，他將討論我們的營運表現和近期業務亮點。我們的首席醫療官 Mohammad Zaki 將討論我們的臨床計劃和最新進展；隨後，我們的財務長 Pepe Carmona 將回顧我們 2025 年第二季的財務表現。然後我們將開始提問。

Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward- looking statements within the meaning of the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance and achievements could differ materially. They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q and 8-K.

在我們開始之前，我想提醒聽眾，本次電話會議中的一些聲明將包含美國 1995 年私人證券訴訟改革法案安全港條款所定義的前瞻性聲明。這些前瞻性陳述受某些已知和未知的風險和不確定性的影響，實際結果、績效和成就可能有重大差異。它們在隨附的幻燈片演示和公司向美國證券交易委員會提交的文件（包括 10-K、10-Q 和 8-K 表格）中進行了識別和描述。

ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward- looking statements contained in this conference call as a result of new information, future events or circumstances, except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements.

ADC Therapeutics 提供的是截至今日的信息，並且不承擔因新資訊、未來事件或情況而更新本次電話會議中包含的任何前瞻性陳述的任何義務，除非法律要求。該公司提醒投資人不要過度依賴這些前瞻性陳述。

Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with that. You should refer to the company's second quarter earnings release for information and reconciliations of historical non-GAAP measures to the comparable GAAP financial measures.

今天的演示還包括非公認會計準則財務報告。這些非公認會計準則衡量指標應作為根據該準則編制的資訊的補充而非孤立地考慮，或作為其替代。您應該參考該公司第二季的收益報告，以了解歷史非 GAAP 指標與可比較 GAAP 財務指標的資訊和對帳情況。

I will now turn the call over to our CEO, Ameet Mallik. Ameet?

現在我將把電話轉給我們的執行長 Ameet Mallik。見面了嗎？

Thanks, Nicole, and hello, everyone. Thank you for joining us on today's call. The second quarter of 2025 represented a period of continued solid performance for our company as well as the presentation of promising key data. Throughout the quarter, we continued to focus on execution and delivering on our commercial strategy, maintaining our place as a treatment option for a third line plus DLBCL patients.

謝謝，妮可，大家好。感謝您參加今天的電話會議。2025 年第二季是我們公司業績持續穩健的時期，同時也呈現了令人鼓舞的關鍵數據。整個季度，我們繼續專注於執行和實現我們的商業策略，保持我們作為第三線及 DLBCL 患者治療選擇的地位。

Net product revenues were $18.1 million and $35.5 million in the second quarter and first half, respectively, both of which were slightly higher, as compared to the same period in the prior year. During the second quarter, we were pleased to have LOTIS-7 data presented at EHA, the European Hematology Association Congress; and at ICML, the International Conference on Malignant Lymphoma. We are encouraged by the promising data, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be a best-in-class combination in a highly competitive market. Data as of the April 2025 cutoff, they chose ZYNLONTA in combination with glofitamab was generally well tolerated with a manageable safety profile.

第二季和上半年的淨產品收入分別為 1,810 萬美元和 3,550 萬美元，與去年同期相比均略有成長。在第二季度，我們很高興在歐洲血液學協會大會 (EHA) 和國際惡性淋巴瘤會議 (ICML) 上展示了 LOTIS-7 數據。這些有希望的數據令我們感到鼓舞，我們相信這表明 ZYNLONTA 加 glofitamab 有可能成為競爭激烈的市場中最佳的組合。截至 2025 年 4 月的數據顯示，他們選擇的 ZYNLONTA 與 glofitamab 聯合使用通常耐受性良好，且安全性可控。

In addition, we believe the combination demonstrated clinically meaningful benefit with an overall response rate of 93.3% and a complete response rate of 86.7% across 30 efficacy-evaluable DLBCL patients. Of note, 25 of the 26 patients achieving CR remained in CR as of the data cutoff. For reference, we have seen complete response rates in other bispecific combination trials in the range of 47% to 62%.

此外，我們相信該組合療法在 30 名可評估療效的 DLBCL 患者中表現出了具有臨床意義的益處，總體緩解率為 93.3%，完全緩解率為 86.7%。值得注意的是，截至數據截止，26 名達到 CR 的患者中有 25 名仍處於 CR 狀態。作為參考，我們在其他雙特異性組合試驗中看到的完全緩解率在 47% 到 62% 的範圍內。

We are currently expanding enrollment to 100 patients at the selected 150-microgram per kilogram dose, which will support regulatory discussions and is in line with recent examples of bispecific combination therapies added to compendia. We expect to

我們目前正在將入組範圍擴大到 100 名患者，劑量選擇為每公斤 150 微克，這將支持監管討論，並且與最近添加到藥典中的雙特異性聯合療法的例子一致。我們期望

share an additional update on LOTIS-7 in the second half of 2025. Once sufficient data with longer follow-up is available, we plan to discuss the path forward for ZYNLONTA and glofitamab with regulatory authorities and to pursue a compendia strategy.

在 2025 年下半年分享更多有關 LOTIS-7 的更新。一旦獲得足夠的數據和更長時間的跟踪，我們計劃與監管機構討論 ZYNLONTA 和 glofitamab 的未來發展方向，並制定綜合策略。

LOTIS-5 remains on track to reach the prespecified number of progression-free survival events by the end of 2025. After the prespecified number of PFS events is reached and data are available, we expect to provide top line data on this Phase III confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with second line plus DLBCL.

LOTIS-5 預計在 2025 年底達到預定的無惡化存活事件數。在達到預定的 PFS 事件數並獲得數據後，我們期望提供有關此項 III 期驗證性試驗的頂線數據，該試驗評估 ZYNLONTA 聯合利妥昔單抗治療二線及以上 DLBCL 患者的效果。

Lastly, updated data presented at ICML from the Phase II IIT in marginal zone lymphoma being led by the Sylvester Comprehensive Cancer Center at University of Miami, showed an overall response rate of 85% and a complete response rate of 69%, with safety consistent with the known profile of ZYNLONTA.

最後，由邁阿密大學西爾維斯特綜合癌症中心領導的邊緣區淋巴瘤 III 期 IIT 研究在 ICML 上公佈的最新數據顯示，總體緩解率為 85%，完全緩解率為 69%，安全性與 ZYNLONTA 的已知特性一致。

Moving beyond ZYNLONTA, we are on track to complete IND-enabling activities for our exatecan-based prostate-specific membrane antigen, or PSMA, targeting ADC by the end of the year. From a corporate perspective, as part of our strategic plan to focus resources on ZYNLONTA, commercialization and expansion opportunities and on our preclinical PSMA targeting ADC, we discontinued early development efforts for all other preclinical programs in solid tumors.

除了 ZYNLONTA 之外，我們還有望在今年年底前完成針對 ADC 的基於依沙替康的前列腺特異性膜抗原 (PSMA) 的 IND 支持活動。從公司角度來看，作為我們策略計畫的一部分，我們將資源集中在 ZYNLONTA、商業化和擴張機會以及針對 ADC 的臨床前 PSMA 上，因此我們停止了所有其他實體腫瘤臨床前計畫的早期開發工作。

As research and development efforts and related programs are closed out, we plan to shut down our U.K. facility reducing our global workforce across functions by approximately 30%. These changes are expected to help position our company for long-term growth with significantly reduced operating expenses.

隨著研發工作和相關項目的結束，我們計劃關閉英國工廠，將全球各職能部門的員工人數減少約 30%。這些變化預計將幫助我們公司實現長期成長，並大幅降低營運費用。

At the same time, we completed a $100 million private placement. Taken together, our expected cash runway now extends into 2028. I'm excited about the multiple upcoming catalysts ahead within this extended cash runway. As a single-agent therapy and third-line plus DLBCL, ZYNLONTA has a profile of rapid, deep and durable efficacy as well as manageable safety with simple and convenient administration.

同時，我們完成了1億美元的私募。總的來說，我們預計現金流將延伸至 2028 年。我對這一延長的現金流中即將出現的多個催化劑感到興奮。ZYNLONTA 作為單藥治療和第三線及以上 DLBCL 治療藥物，具有快速、深度和持久的療效以及可控的安全性，給藥簡單方便。

Beyond our current indication, we believe in the potential to reach significantly more patients while growing the commercial opportunity by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. The data we've seen across these settings so far has been consistently encouraging with the potential to be highly differentiating.

除了目前的適應症之外，我們相信，透過擴大其在 DLBCL 和惰性淋巴瘤的早期治療中的應用，我們可以惠及更多的患者，同時增加商業機會。到目前為止，我們在這些環境中看到的數據一直令人鼓舞，並且具有高度差異化的潛力。

Within our current indication, our commercial strategy is focused on relapsed and refractory DLBCL patients who need a treatment with a fast, durable response and a manageable safety profile, which can be administered in the outpatient setting. We believe LOTIS-5 has the potential to take ZYNLONTA to $200 million to $300 million in peak sales as we expand into the second-line setting.

在我們目前的適應症範圍內，我們的商業策略專注於復發和難治性 DLBCL 患者，他們需要一種具有快速、持久反應和可控安全性的治療方法，可以在門診進行。我們相信，隨著我們擴展到二線市場，LOTIS-5 有潛力使 ZYNLONTA 的峰值銷售額達到 2 億至 3 億美元。

This is driven by doubling the patient population, extending the duration of therapy and improving the clinical profile versus our current indication as a monotherapy. The LOTIS-7, we estimate we can expand the total opportunity for ZYNLONTA in DLBCL to $500 million to $800 million in peak revenue with regulatory approval and compendia listing.

這是透過增加患者數量、延長治療時間以及改善臨床狀況（相對於我們目前的單一療法）來實現的。透過 LOTIS-7，我們估計，透過監管部門的批准和藥典的列出，我們可以將 ZYNLONTA 在 DLBCL 中的總機會擴大到 5 億至 8 億美元的峰值收入。

If the data persists, we believe ZYNLONTA plus glofitamab has the potential to transform the future lymphoma treatment paradigm by becoming the preferred bispecific combination in the second line plus DLBCL setting. Additionally, in indolent lymphomas, there is a clear unmet need in both the relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma settings.

如果數據持續存在，我們相信 ZYNLONTA 加 glofitamab 有可能成為二線加 DLBCL 環境中首選的雙特異性組合，從而改變未來的淋巴瘤治療模式。此外，在惰性淋巴瘤中，復發或難治性邊緣區淋巴瘤和復發或難治性濾泡性淋巴瘤明顯存在未滿足的需求。

We are encouraged by the initial data seen in the Phase II IITs suggesting a ZYNLONTA regimen could provide significant benefit for these patients. We believe the indolent lymphomas opportunity could provide additional peak revenue of $100 million to $200 million with regulatory approval and compendia listing, primarily driven by MZL.

我們對 II 期 IIT 中的初步數據感到鼓舞，這些數據表明 ZYNLONTA 方案可以為這些患者帶來顯著益處。我們相信，惰性淋巴瘤機會可以透過監管部門的批准和藥典上市帶來 1 億至 2 億美元的額外高峰收入，這主要由 MZL 推動。

Taken together, we believe ZYNLONTA has the potential to reach peak revenues of $600 million to $1 billion in the US. Looking at the overall DLBCL treatment landscape, whether in the second or third line setting, there are two main segments. The first are complex therapies, which require unique infrastructure and expertise to handle logistical requirements and patient management. This includes therapies like CAR T, transplant and bispecifics.

綜合來看，我們相信 ZYNLONTA 在美國有潛力達到 6 億至 10 億美元的最高收入。縱觀整個 DLBCL 治療格局，無論是二線或三線治療，主要分為兩個部分。首先是複雜的治療方法，需要獨特的基礎設施和專業知識來處理後勤要求和病患管理。這包括 CAR T、移植和雙特異性等療法。

The second are more broadly accessible therapies, which all physicians can administer in the outpatient setting, including therapies like ADCs monoclonal antibodies and chemotherapy. Biospecifics have already been approved in the third line plus 7 as monotherapy, and we estimate there is currently a 60-40 split between the complex and broadly accessible segments, respectively.

第二種是更廣泛可及的治療方法，所有醫生都可以在門診進行治療，包括 ADC 單株抗體和化療等療法。生物特異性藥物已在三線及七線藥物中作為單一療法獲得批准，我們估計目前複雜藥物和廣泛可及藥物部分的比例分別為 60% 和 40%。

In the second line, where bispecifics have not yet been approved, but were recently added to NCCN guidelines for use in combination, the estimated split is closer to 25/75. We believe the emerging clinical profile of ZYNLONTA plus glofitamab in the LOTIS-7 trial positions us well among complex therapies and at the same time, the clinical profile of ZYNLONTA plus rituximab in the LOTIS-5 trial has the potential to differentiate us among broadly accesible therapies.

在第二行中，雙特異性抗體尚未獲得批准，但最近被添加到 NCCN 指南中以供聯合使用，估計的比例接近 25/75。我們相信，LOTIS-7 試驗中 ZYNLONTA 加 glofitamab 的新臨床特徵使我們在複雜療法中處於有利地位，同時，LOTIS-5 試驗中 ZYNLONTA 加利妥昔單抗的臨床特徵有可能使我們在廣泛可及的療法中脫穎而出。

While ZYNLONTA is currently approved as a single agent in third line plus DLBCL, we believe ZYNLONTA has the potential to be the backbone therapy for combinations, raising the bar for efficacy in second line plus DLBCL. ZYNLONTA is a systemic chemo- free option, which can be combined with the highly effective bispecific glofitamab and the most widely used agent, rituximab.

雖然 ZYNLONTA 目前已被批准為第三線及以上 DLBCL 的單一藥物，但我們相信 ZYNLONTA 有可能成為聯合治療的骨幹療法，從而提高二線及以上 DLBCL 的療效標準​​。ZYNLONTA 是一種無需全身化療的治療選擇，可與高效的雙特異性 glofitamab 和最廣泛使用的藥物利妥昔單抗聯合使用。

We believe ZYNLONTA plus glofitamab in LOTIS-7 and ZYNLONTA plus rituximab in LOTIS-5, our complementary approaches to addressing unmet needs in the two key treatment segments.

我們相信 LOTIS-7 中的 ZYNLONTA 加 glofitamab 以及 LOTIS-5 中的 ZYNLONTA 加 rituximab 是我們解決兩個關鍵治療領域中未滿足需求的互補方法。

Now I will turn the call over to our Chief Medical Officer, Mohamed Zaki, who will share more on our ongoing trials. Mohamed?

現在，我將把電話轉給我們的首席醫療官穆罕默德·扎基 (Mohamed Zaki)，他將分享更多有關我們正在進行的試驗的信息。穆罕默德？

Thank you, Ameet. Initial data from the 50 leading (inaudible) Phase III confirmatory study of ZYNLONTA in combination with rituximab in patients with second-line plus DLBCL showed an overall response rate of 80% and a complete response rate of 50% with no new safety segments, demonstrating that this combination has the potential to provide competitive second-line plus efficacy with a favorable safety profile allowing broad accessibility. Enrollment is now complete, and we expect to reach the prespecified number of events by the end of 2025 and will provide data once available. The supplement and BLA submission to regulatory authorities is anticipated in the first half of 2026 with potential confirmatory approval in second line plus DLBCL in the first half of 2027.

謝謝你，Ameet。ZYNLONTA 合併利妥昔單抗治療二線以上 DLBCL 患者的 50 項領先（聽不清楚）III 期驗證性研究的初步數據顯示，整體緩解率為 80%，完全緩解率為 50%，且沒有新的安全分段，顯示這種組合有可能提供有競爭力的二線以上療效，具有良好的安全性，可廣泛使用。報名現已完成，我們預計到 2025 年底將達到預定的活動數量，並將在數據可用時提供。預計將於 2026 年上半年向監管機構提交補充資料和 BLA，並可能於 2027 年上半年獲得二線及 DLBCL 的確認批准。

With LOTIS-7, we are exploring the combination of ZYNLONTA and Anti-CD19 ADC with Glofitamab and anti-CD20/CD3 T-cell engaging bispecific antibody. These two highly reported single-agent drugs offer important and complementary (inaudible) action in DLBCL.

利用 LOTIS-7，我們正在探索 ZYNLONTA 和抗 CD19 ADC 與 Glofitamab 和抗 CD20/CD3 T 細胞結合雙特異性抗體的組合。這兩種被廣泛報導的單一藥物對 DLBCL 具有重要且互補的（聽不清楚）作用。

We started with two different B-cell separate engines while delivering important payloads and activating T cells. Given this, we expect to see additive or synergistic efficacy. In addition, there are no known overlapping nonhematologic toxicities between the two agents. By dosing ZYNLONTA prior to glofitamab, it is our hypothesis that this dosing schedule has the potential to debulk the tumor and to lower CRS rates and grades.

我們從兩個不同的 B 細胞獨立引擎開始，同時傳遞重要的有效載荷並激活 T 細胞。有鑑於此，我們期望看到附加或協同效應。此外，兩種藥物之間沒有已知的重疊非血液學毒性。透過在 glofitamab 之前使用 ZYNLONTA，我們假設這種給藥方案有可能縮小腫瘤並降低 CRS 發生率和等級。

The design of the trial includes two parts: Part one, dose escalation was conducted across non-Hodgkin lymphoma patients at three dose levels of ZYNLONTA with glofitamab or mosunetuzumab in the third line plus. Part two dose expansion was conducted in the second line plus, plus B-cell lymphoma with ZYNLONTA at 2-dose level, 120-micrograms per kg and the currently approved monotherapy dose of 150-microgram per kg combined with the approved monotherapy dose of glofitamab.

試驗設計包括兩部分：第一部分，對非何杰金氏淋巴瘤患者進行 ZYNLONTA 三個劑量水平的劑量遞增，並在第三線治療中使用 glofitamab 或 mosunetuzumab。第二部分劑量擴展是在二線及以上 B 細胞淋巴瘤中進行的，使用 2 劑量水平的 ZYNLONTA、120 微克/公斤和目前批准的單藥治療劑量 150 微克/公斤與批准的單藥治療劑量 glofitamab 相結合。

Based on this initial dose optimization, we selected the 150 micrographs per kg dose for expansion to 100 patients at this dose level. ZYNLONTA is being given prior to glofitamab to potentially debulk the tumor in the first cycle and then both (inaudible) given together in subsequent cycles. The primary endpoint is safety and tolerability and second end point of efficacy, PK and immunogenicity.

基於此初始劑量優化，我們選擇每公斤 150 微張的劑量，以該劑量水平擴展到 100 名患者。ZYNLONTA 在 glofitamab 之前使用，以便在第一個週期中潛在地減少腫瘤，然後在後續週期中同時使用兩者（聽不清楚）。主要終點是安全性和耐受性，第二終點是療效、PK 和免疫原性。

Baseline characteristics in this study, including being refracting to prior therapy as well as number and types of prior therapies are representative of the second line DLBCL patient population and similar to other studies in this space. Among the 41 patients evaluable for safety, there are certain characteristics that are important to highlight.

本研究中的基線特徵，包括對先前治療的反應以及先前治療的數量和類型，代表了二線 DLBCL 患者群體，並且與該領域的其他研究相似。在 41 名可進行安全性評估的患者中，有一些重要的特徵值得強調。

The median age in this study is 71 with averaging to 26 to 85 years of age. The study enrolled patients with large B-cell lymphoma, including (inaudible) DLBCL, transformed follicular lymphoma, high-grade B-cell lymphoma and grade 3D follicular lymphoma, all considered to be DLBCL.

本研究的中位數年齡為 71 歲，平均年齡為 26 至 85 歲。該研究招募了大 B 細胞淋巴瘤患者，包括（聽不清楚）DLBCL、轉化性濾泡性淋巴瘤、高級別 B 細胞淋巴瘤和 3D 級濾泡性淋巴瘤，這些都被認為是 DLBCL。

Median prior lines of therapy was 2, with a range from 1 to 5. The study includes a number of difficult-to-treat large B-cell lymphoma patients. Nearly 20% of patients presented at double or triple hit, 19.5% of patients received prior CAR-T, which is in line with other trials done with bispecific combinations.

先前治療的中位數為 2，範圍從 1 到 5。該研究包括許多難以治療的大 B 細胞淋巴瘤患者。近 20% 的患者出現雙重或三重打擊，19.5% 的患者曾接受 CAR-T 治療，這與其他雙特異性組合試驗的結果一致。

Patients reflected with prior therapy were well represented in the study with 51% of patients reflecting the primary therapy and 41% reflected last prior therapy, both of which were slightly higher in the 150-microgram per kg compared to 120-microgram per kg dose. Safety was analyzed in the 41 large B-cell lymphoma patients who received at least one dose of ZYNLONTA plus glofitamab.

研究中反映出接受過既往治療的患者佔比很高，其中 51% 的患者反映了主要治療，41% 的患者反映了上次既往治療，兩者在 150 微克/公斤劑量下均略高於 120 微克/公斤劑量下。在接受至少一劑 ZYNLONTA 加 glofitamab 治療的 41 名大 B 細胞淋巴瘤患者中分析了安全性。

Most notably, as mentioned during the presentation of this data at ASH, when looking at Grade 3 and 4 treatment-emergent adverse events occurring in more than 5% of patients, neutropenia was the most common at 24.4%, which is similar to the rate of neutropenia reported in the prescribing information of each drug separately.

最值得注意的是，正如在 ASH 上展示這些數據時所提到的，當查看超過 5% 的患者發生的 3 級和 4 級治療出現的不良事件時，中性粒細胞減少症最為常見，為 24.4%，這與每種藥物處方資訊中分別報告的中性粒細胞減少症發生率相似。

So no additive effects were observed. Beyond that, the type of treatment-emergent adverse events observed are consistent with the known safety profile of each drug separately. The rate of serious treatment-emergent adverse events were similar across both doses, only three of the 20 patients experiencing serious treatment emergent adverse event discontinued treatment.

因此沒有觀察到附加效應。除此之外，觀察到的治療中出現的不良事件類型與每種藥物已知的安全性一致。兩種劑量的嚴重治療引起的不良事件發生率相似，在 20 名出現嚴重治療引起的不良事件的患者中，只有 3 名停止了治療。

As of the data cutoff, the combination has shown a manageable safety profile and no new safety signal was observed. A total of six patients discontinued due to adverse events, three of which were serious treatment-emergent adverse events.

截至資料截止，該組合顯示出可控的安全性，並且沒有觀察到新的安全性訊號。共有六名患者因不良事件而停藥，其中三名是嚴重的治療引起的不良事件。

On ZYNLONTA, we saw one case each of pericardial effusion, generalized edema and pleural effusion. And for glofitamab, we saw one case of ICANS, polyneuropathy and febrile neutropenia. This is consistent with the loan profile of each drug separately. As of the data cutoff date, we can see that overall rates and grade of CRS are higher at the 120-microgram per kg dose compared to the 150- microgram per kg dose. The 120-microgram per kg dose had 55% any grade CRS primarily Grade 1, 2 with one case of Grade 3. The 150-microgram per kg dose had 23.8% any grade CRS, all of which was Grade 1. Grade 1 and 2 CRS were managed using standard of care therapies without ICU admittance or pressure support.

在 ZYNLONTA 上，我們觀察到心包膜積水、全身水腫和胸腔積水各一例。對於格洛菲塔瑪，我們發現了一例 ICANS、多發性神經病變和發燒性嗜中性白血球減少症。這與每種藥物的貸款情況一致。截至數據截止日期，我們可以看到，與每公斤 150 微克的劑量相比，每公斤 120 微克的劑量下 CRS 的總體發生率和等級更高。每公斤 120 微克劑量組有 55% 的 CRS 發生率，主要為 1 級、2 級，1 例為 3 級。每公斤 150 微克劑量組有 23.8% 出現任何等級的 CRS，全部為 1 級。1 級和 2 級 CRS 採用標準護理療法進行治療，無需 ICU 入院或壓力支持。

The Grade 3 CRS, world managed with standard of care therapies and included ICU admittance. ICANS were seen in two patients treated at the 120-microgram per kg and 1 ICANS were observed at 150-microgram per kg dose. These ICANS were low grade and primarily managed with corticosteroids. All patients had a complete resolution of symptoms with one patient electing to discontinue treatment and two patients resuming treatment and ultimately achieving a complete response.

3 級 CRS，世界各地採用標準護理療法進行管理並包括 ICU 入院。接受 120 微克/公斤劑量治療的兩名患者出現了 ICANS，接受 150 微克/公斤劑量治療的一名患者出現了 ICANS。這些 ICANS 等級較低，主要使用皮質類固醇治療。所有患者的症狀均完全緩解，其中一名患者選擇停止治療，兩名患者恢復治療並最終獲得完全緩解。

Of the 41 treated patients at the time of the April data cutoff, 30 patients have reached the initial disease assessment and were efficacy evaluable. In this study, we have seen 93.3% overall response rate and 86.7% complete response rate. Median division of response was not reached at the time of data cutoff. The results observed across those levels were consistent in the terms of ORR, CR and PR.

截至 4 月數據截止時，接受治療的 41 名患者中，有 30 名已達到初步疾病評估並可評估療效。在這項研究中，我們看到整體反應率為 93.3%，完全反應率為 86.7%。數據截止時尚未達到回應的中位數。在這些層面上觀察到的結果在 ORR、CR 和 PR 方面是一致的。

Looking now at the swimmer's block. The green bars show all patients in complete response and the length of this bar shows the durability of each response. The gray bars represents who have not yet made it to the first disease assessment so are not yet available for response.

現在看看游泳區。綠色條表示所有患者均已完全緩解，且該條的長度表示每次緩解的持久性。灰色條代表尚未進行第一次疾病評估，因此尚無法做出反應。

Most responses were observed at initial assessments, which occurred at day 42. 25 out of 26 patients who achieved a complete response have maintained that response as of the data cutoff and 12 patients converted from stable disease or partial response to complete response over time. As the data cutoff, the longest response in the study is more than a year.

大多數反應是在第 42 天的初步評估中觀察到的。在 26 名獲得完全緩解的患者中，有 25 名在數據截止時保持了這種緩解，並且 12 名患者隨著時間的推移從病情穩定或部分緩解轉變為完全緩解。作為數據截止，研究中最長的反應超過一年。

Complete responses were observed regardless of the prior therapy.

無論之前接受過何種治療，均觀察到完全緩解。

Of the six patients previously treated with CAR-T and undergoing response assessment, five achieved a CR. The impressive efficacy and manageable safety profile seen with the combination of ZYNLONTA and glofitamab is encouraged. The data reinforces our belief in the potential for this regimen to change the treatment paradigm for patients with aggressive lymphoma.

在先前接受過 CAR-T 治療並正在接受反應評估的六名患者中，有五名達到了 CR。ZYNLONTA 和 glofitamab 聯合使用所表現出的令人印象深刻的療效和可控的安全性令人鼓舞。這些數據強化了我們的信念，即該方案有可能改變侵襲性淋巴瘤患者的治療模式。

Now, I will turn the call over to Pepe Carmona our CFO, who will discuss financial results for the second quarter. Pepe?

現在，我將把電話轉給我們的財務長 Pepe Carmona，他將討論第二季的財務表現。佩佩？

Thank you, Mohamed. On the financial front, ZYNLONTA net product revenues in the second quarter of 2025 were $18.1 million as compared to $17 million in the same quarter of 2024. Our first half net product revenue was $35.5 million compared to $34.9 million during the first half 2024. In connection with the strategic reprioritization and restructuring plan announced in June 2025, the company incurred $13.1 million in restructuring and impairment cost in the second quarter of 2025, which consisted of $6.7 million in employee severance and related benefit costs and $6.4 million in noncash impairment assets in connection with the close down of the U.K. facility.

謝謝你，穆罕默德。財務方面，ZYNLONTA 2025 年第二季的淨產品收入為 1,810 萬美元，而 2024 年同期為 1,700 萬美元。我們上半年的淨產品收入為 3,550 萬美元，而 2024 年上半年為 3,490 萬美元。與 2025 年 6 月宣布的戰略重新排序和重組計劃相關，該公司在 2025 年第二季度發生了 1,310 萬美元的重組和減值成本，其中包括 670 萬美元的員工遣散費和相關福利成本以及 640 萬美元與英國工廠關閉相關的非現金減值資產。

Total operating expenses for the quarter were $47.8 million on a non-GAAP basis, representing an 8% increase over prior year, primarily driven by higher R&D costs, mostly related to LOTIS-5 and LOTIS-7 as well as PSMA IND-enabling activities. The expenses on the ZYNLONTA LOTIS-5 trial, which is the largest investment we are making is expected to decrease as we complete the trial going into 2026.

本季度非公認會計準則下的總營運費用為 4,780 萬美元，比上年增長 8%，主要由於研發成本增加，主要與 LOTIS-5 和 LOTIS-7 以及 PSMA IND 支援活動有關。ZYNLONTA LOTIS-5 試驗是我們進行的最大投資，隨著我們在 2026 年完成試驗，其費用預計會減少。

On a GAAP basis, we reported a net loss of $56.6 million for the second quarter of 2025 or $0.50 per basic and diluted share. As compared to a net loss of $36.5 million or $0.38 per basic and diluted share for the same period in 2024.

根據 GAAP 計算，我們報告 2025 年第二季淨虧損 5,660 萬美元，即每股基本虧損和稀釋虧損 0.50 美元。相較之下，2024 年同期的淨虧損為 3,650 萬美元，即每股基本虧損和稀釋虧損均為 0.38 美元。

The increase in net loss for the quarter is primarily attributable to onetime restructuring and impairment costs and higher R&D expenses. You can find the reconciliation of GAAP to non-GAAP measures in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation.

本季淨虧損的增加主要歸因於一次性重組和減損成本以及更高的研發費用。您可以在今天早些時候發布的新聞稿的財務表格和本簡報的附錄中找到 GAAP 與非 GAAP 指標的對帳。

As of June 30, 2025, cash and cash equivalents were $264.6 million compared to $194.7 million at March 31, 2025. This change was primarily driven by the net proceeds received in the company's private placement, partially offset by our use of cash in operating activities for the quarter. Across the LOTIS-5, LOTIS-7 and MZLs and launch programs, we expect to have multiple data catalysts in the remainder of 2025 and 2026 with potential LOTIS-5 approval and compendia listing for all of this in the first half of 2027.

截至 2025 年 6 月 30 日，現金及現金等價物為 2.646 億美元，而 2025 年 3 月 31 日為 1.947 億美元。這項變更主要由公司私募獲得的淨收益所驅動，部分被我們本季經營活動中的現金使用所抵銷。在 LOTIS-5、LOTIS-7 和 MZL 以及啟動計劃中，我們預計在 2025 年剩餘時間和 2026 年將有多個數據催化劑，並且所有這些催化劑都可能在 2027 年上半年獲得 LOTIS-5 批准和列入藥典。

For LOTIS-5, we expect to reach the prespecified number of PFS events by the end of this year, with top line results and potential supplemental BLA submission in the first half of next year. With LOTIS-7, we intend to share fewer, more mature data toward the end of this year and expect to complete enrollment of 100 patients at the 150-microgram per kilogram dose in the first half of next year.

對於 LOTIS-5，我們預計今年年底將達到預定的 PFS 事件數量，並在明年上半年獲得頂線結果和潛在的補充 BLA 提交。透過 LOTIS-7，我們打算在今年年底前分享更少、更成熟的數據，並預計在明年上半年完成 100 名劑量為 150 微克/公斤的患者入組。

We plan to engage with regulatory autologies starting later this year. With sufficient data, we will pursue publication and a potential competitive strategy. With indolent lymphomas, we expect additional data to be shared at medical conferences this year and next by the lead investigators.

我們計劃從今年稍後開始參與監管自主論。有了足夠的數據，我們將進行出版並制定潛在的競爭策略。對於惰性淋巴瘤，我們期望主要研究人員在今年和明年的醫學會議上分享更多數據。

Beyond ZYNLONTA, we are excited to see the advancement of our exatecan-based PSMA targeting ADC with potential completion of IND-enabling activities towards the end of this year. Overall, we believe we have multiple value-driving catalysts within our cash runway, which is expected to extend into 2028.

除了 ZYNLONTA 之外，我們很高興看到基於依沙替康的 PSMA 針對 ADC 的進展，並有可能在今年年底完成 IND 支援活動。總體而言，我們相信我們的現金流中擁有多個價值驅動催化劑，預計將延續到 2028 年。

I will now turn the call back to Ameet.

我現在將電話轉回給 Ameet。

Thank you, Pepe. I am pleased with how we are executing against our strategy and continue to be encouraged by the consistently promising ZYNLONTA data we are generating across our ongoing trials. We believe our revenue growth opportunity comes with expanded use of ZYNLONTA through regulatory approvals as well as inclusion in guidelines. And we are confident in the multiple pathways we have to achieve our peak revenue goal.

謝謝你，佩佩。我對我們如何執行我們的策略感到滿意，我們在正在進行的試驗中不斷產生的 ZYNLONTA 數據也給我帶來了持續的鼓舞。我們相信，透過監管部門的批准以及納入指南，ZYNLONTA 的使用範圍將擴大，這將為我們帶來收入成長的機會。我們對實現高峰收入目標的多種途徑充滿信心。

We can now open the line for questions. Operator?

現在我們可以開通問答專線了。操作員？

(Operator Instructions)

（操作員指示）

Michael Schmidt, Guggenheim. Your line is now open.

古根漢美術館的麥可·施密特。您的線路現已開通。

Hi guys, good morning. Thanks for taking my questions. I had two bigger picture questions, I guess. One is on the Roche complete response letter recently on glofitamab in second-line DLBCL, I'm just curious what your view is, how you think this may affect the overall DLBCL market in a second-line setting and then perhaps also any impact of that on your trial collaboration or potential next steps?

大家好，早安。感謝您回答我的問題。我想我有兩個更大的問題。一個是關於羅氏公司最近關於二線 DLBCL 的 glofitamab 的完全回應信，我只是好奇您的看法，您認為這會如何影響二線環境中的整體 DLBCL 市場，然後也許還會對您的試驗合作或潛在的後續步驟產生任何影響？

And then the second question was really around LOTIS-5. And I know you've the reaffirmed timing of the PFS analysis by year-end. And I'm just wondering if you had a sense of how mature overall survival is by the end of this year and presumably there will be an interim OS analysis as well. I just wanted to confirm that. Thank you.

第二個問題其實是關於 LOTIS-5 的。我知道您已經重申了年底前進行 PFS 分析的時間。我只是想知道您是否了解今年年底整體存活率有多成熟，並且大概還會有一個中期 OS 分析。我只是想確認一下。謝謝。

Okay. Thanks for both of your questions. So the first one was around STARGLO, the CRL that they received and any impact that we see that could happen for us? And the second question was around LOTIS-5 and LOTIS-7 of OS or interim OS analysis would be when we have, when we get to top line results. So I'll turn it to Mohamed, first, to talk about the CRL with STARGLO and maybe I'll also highlight some differences between how we've conducted some of our trials like LOTIS-5 and the STARGLO study.

好的。謝謝你們兩個的提問。那麼第一個問題是關於 STARGLO、他們收到的 CRL 以及我們認為可能對我們產生的影響？第二個問題是關於 LOTIS-5 和 LOTIS-7 的 OS 或中期 OS 分析，當我們獲得頂線結果時會進行分析。因此，我首先請穆罕默德談談 CRL 與 STARGLO，也許我也會強調我們進行的一些試驗（如 LOTIS-5 和 STARGLO 研究）之間的一些差異。

Sure. Thanks, Ameet. And thanks for the question, of course. The CRL that was received by Roche from the FDA, we don't really know the details of that. So it's really hard to comment on that specific later. However, we remain confident that there is an unmet medical need in the second line plus DLBCL landscape. And also, we remain confident that the LOTIS-5 and LOTIS-7 is well positioned to address the unmet need in that study, specifically for people who are not -- or not suitable for complex therapy. I want to highlight also what is LOTIS-5 that makes us comfortable.

當然。謝謝，Ameet。當然，感謝您的提問。羅氏從 FDA 收到的 CRL，我們確實不知道其具體細節。因此稍後很難對此具體內容發表評論。然而，我們仍然相信，二線以上 DLBCL 領域存在未滿足的醫療需求。此外，我們仍然相信 LOTIS-5 和 LOTIS-7 能夠很好地解決研究中未被滿足的需求，特別是對於不適合或不適合複雜治療的人。我還想強調一下 LOTIS-5 帶給我們的舒適感。

First of all, it's a large study for 120 patients. In addition, also, it's randomized one to ine and powered at 90% is the assumption that R-GemOx will give about four months, all the studies required to show two months difference, six months in the test arm to the study to be successful.

首先，這是一項針對 120 名患者的大型研究。此外，研究還採用一對一隨機試驗，假設 R-GemOx 將在大約四個月的時間內，在測試組中顯示兩個月的差異，在六個月的時間內，90% 的功效使研究取得成功。

Also, we're very comfortable with the data shared with the early 51% -- with the 50% complete response and 8% to our PFS of 8.3 months in that disease setting. That's for our comfort regarding the differences. Also, I think we shared before that our enrollment in Asia was significantly lower than what STARGLO study was.

此外，我們對早期 51% 的數據感到非常滿意——在該疾病環境下，完全緩解率為 50%，PFS 為 8.3 個月，佔 8%。這是為了讓我們對差異感到安心。另外，我想我們之前分享過，我們在亞洲的入學人數明顯低於 STARGLO 研究的入學人數。

In terms of interim, of course, at the final analysis of PFS, there are always -- FDA really asked it looks for how much data on OS is available and we will get there, we'll be able to talk more about that when we reach the final PFS announced.

當然，就中期而言，在 PFS 的最終分析中，總是有 - FDA 確實要求它尋找有多少關於 OS 的數據，我們將到達那裡，當我們宣布最終的 PFS 時，我們將能夠更多地談論這一點。

Just maybe a follow-up. Is your expectation that OS at that point in time is mature enough to potentially show a difference? Or is it just too early in terms of the event rates by the end of this year?

也許只是後續行動。您是否預期那時的作業系統已經夠成熟，有可能顯示出差異？或者就今年年底的活動率而言，現在還為時過早嗎？

It is really hard to speculate on that for now. So to be honest with you, it's hard to tell.

目前確實很難對此作出推測。所以說實話，這很難說。

Yes. And then basically, Michael, just so you understand the timing. I mean what we said is we believe we'll hit the prespecified number of PFS events by the end of this year. Obviously, then you have to clean the data, lock the database. Once that happens, we would share sort of top line meeting is the data positive or negative. But the full results of the trial would obviously get published in go to a medical congress. And that's when the full data will come out. In parallel, obviously, we'll be engaging and preparing for the sBLA submission with the FDA.

是的。然後基本上，邁克爾，你就可以了解時間了。我的意思是，我們相信到今年年底我們將達到預定的 PFS 事件數量。顯然，然後你必須清理數據，鎖定資料庫。一旦發生這種情況，我們將在會議上分享一些重要訊息，無論是正面數據還是負面數據。但試驗的全部結果顯然會在醫學大會上公佈。那時完整的數據就會出來。同時，顯然，我們將與 FDA 合作並準備提交 sBLA。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

Hi, good morning. This is Jenna on the line for Kelly. Could you please give us some updated thoughts on durability of these impressive high CRs seen from LOTIS-5 and LOTIS-7. How much incremental durability benefit would you expect, maybe versus glofitamab alone for LOTIS-7 and for these two trials, how may that compare with other rituximab or glofitamab combos? And then for the LOTIS-7 update coming in the second half, what kind of early read into durability may we expect there? Thank you so much.

嗨，早安。我是詹娜，找凱利。您能否就 LOTIS-5 和 LOTIS-7 中這些令人印象深刻的高 CR 的耐用性給我們提供一些最新的看法。您預期增量耐久性效益會有多大，與 LOTIS-7 單獨使用 glofitamab 相比，對於這兩個試驗，與其他利妥昔單抗或 glofitamab 組合相比如何？那麼對於下半年即將推出的 LOTIS-7 更新，我們可以期待對耐用性有什麼樣的早期解讀？太感謝了。

Yes. Thanks for the question. So you're asking, I think about not only the high CRAs that we've seen with LOTIS-7, but you're asking about the durability and what gives us confidence in the durability and what measures of durability will we start to see over time to get -- to demonstrate that durability of the CRs. So I'll turn it to Mohamed to talk about, one, why we believe we will see good durability, but also what metrics we'll be able to show over time to demonstrate that durability of the CRs.

是的。謝謝你的提問。所以你問的是，我不僅考慮了我們在 LOTIS-7 中看到的高 CRA，還考慮了耐用性，以及什麼讓我們對耐用性有信心，以及隨著時間的推移，我們將開始看到哪些耐用性指標——以證明 CR 的耐用性。因此，我將請穆罕默德來談談，首先，為什麼我們相信我們會看到良好的耐用性，而且隨著時間的推移，我們將能夠展示哪些指標來證明 CR 的耐用性。

It's important to highlight that the high number or maybe unprecedented number of CRs observed in LOTIS-7 so far is very encouraging, and very important also to highlight that we all know that the CRs are a good surge biomarker for durability. Both drugs, each one separately are showing significant durabilities in third line plus with the median duration of response in the CR patients, not reached for glofitamab for three years and for longer for two years.

值得強調的是，迄今為止在 LOTIS-7 中觀察到的大量或前所未有的 CR 數量非常令人鼓舞，同樣值得強調的是，我們都知道 CR 是耐久性的良好激增生物標誌物。兩種藥物在第三線治療中均表現出顯著的耐久性，且在 CR 患者中，Glofitamab 的中位反應持續時間為三年，而 CR 患者的中位反應持續時間為兩年。

So we're also looking forward to continuing at the data, and we'll be sharing more updated data by the end of this year. It is also encouraging to share that based on the durability or looking at so far, the important to highlight that the median CRA that have been seen by other combination bispecifics, is ranging between 47% and 62%.

因此，我們也期待繼續研究數據，並將在今年底分享更多更新的數據。令人鼓舞的是，基於耐久性或從目前的情況來看，需要強調的是，其他組合雙特異性抗體的中位數 CRA 在 47% 到 62% 之間。

I actually know that our numbers are higher than that. And the additional response of 12 months for those studies ranging between 63% to 75%. Also, it's important to highlight that with our focus in our benchmarking on the durability at 6 and 12 months and more, of course, as we get more better. So we keep monitoring this data, but is very encouraging right now, as I mentioned before, 25 out of 26 CRs remains in CR at the time of data cutoff with the longest of them reaching more than a year.

我實際上知道我們的數字要高於這個數字。對於那些 63% 至 75% 之間的研究，額外的回應時間為 12 個月。此外，值得強調的是，我們在基準測試中專注於 6 個月、12 個月甚至更長的耐用性，當然，我們會做得更好。因此，我們一直在監測這些數據，但目前的情況非常令人鼓舞，正如我之前提到的，在數據截止時，26 個 CR 中有 25 個仍然處於 CR 狀態，其中最長的一個達到一年多。

Yes. So on the future data updates, you're going to see, obviously, updated swimmer plot. That's obviously a great indication of durability when you see individual patients, so how durable those CRs are, but like other studies, we'll be able to talk about the medium duration of the CRs at 6 and 12 months as the data matures, and we have sufficient data to share on that. So you'll see more durability data as we kind of give future updates.

是的。因此，在未來的數據更新中，您顯然會看到更新的游泳者圖。當您看到個別患者時，這顯然是持久性的一個很好的指標，因此這些 CR 的持久性如何，但與其他研究一樣，隨著數據的成熟，我們將能夠討論 6 個月和 12 個月的 CR 的中期持續時間，並且我們有足夠的數據可以分享。因此，當我們提供未來更新時，您將看到更多耐用性數據。

Thank you.

謝謝。

Eric Schmidt, Cantor.

埃里克·施密特，康托爾。

Thanks for my question. Congrats on the progress in Q2. Maybe just a quick one with regard to LOTIS-7 and your discussions with the FDA. What is it that you're hoping to get asked and answered and how might you communicate that result? And maybe also how might you communicate the LOTIS-7 data later this year, would that be at a conference or company-sponsored event? Thank you.

謝謝你的提問。恭喜第二季度取得進展。也許只是關於 LOTIS-7 和您與 FDA 的討論的簡短問題。您希望得到什麼問題和答案以及如何傳達結果？也許您今年稍後會如何傳達 LOTIS-7 數據，是在會議還是公司贊助的活動中？謝謝。

Yes. So maybe I'll start and then I'm going to pass it to Mohamed. So first of all, with LOTUS 7, as you're aware, and we've communicated we currently have expanded the trial to enroll 100 patients at the 150-microgram per kilogram dose of ZYNLONTA

是的。所以也許我會開始，然後我會把它傳遞給穆罕默德。首先，如您所知，對於 LOTUS 7，我們已經告知，我們目前已擴大試驗範圍，招募 100 名患者，接受 150 微克/公斤劑量的 ZYNLONTA

plus the full dose of glofitamab, that's well underway. That's -- it's actually -- we've seen the enrollment do quite well. It's accelerated. And so that path towards being able to get published and get into compendia is a strategy that's kind of ongoing.

加上全劑量的 glofitamab，一切進展順利。事實上，我們已經看到入學人數表現相當不錯。它加速了。因此，實現出版和收錄到文集的途徑是一種持續的策略。

In parallel, obviously, as the data matures, we want to engage with the FDA on a potential path forward, but that could be, whether it be in second line or front line that we can explore different options with the FDA. So that's one of the things we want to test. Maybe, Mohamed, you could talk more about what we want to do with the FDA in those discussions about potential regulatory approaches.

同時，顯然，隨著數據的成熟，我們希望與 FDA 合作尋找潛在的前進道路，但無論是在第二線還是在第一線，我們都可以與 FDA 一起探索不同的選擇。這是我們想要測試的事情之一。穆罕默德，也許你可以在有關潛在監管方法的討論中更多地談談我們想與 FDA 合作做些什麼。

Yes. Typically, we're going to have some data on sufficient follow-up. The discussion with the agency could range between how to bring such an effective regimen to patients quickly. And also what is the future development plan more than just having it quicker on the bigger picture -- but bigger studies for second or front line, as Ameet mentioned. Of course, there's a discussion about what dose is, other things like that could come into the conversation. So it's actually the timing to do there will depend on how the data and then on the follow-up that we have, and we have a fruitful discussion with the agency.

是的。通常，我們會有一些關於足夠後續行動的數據。與該機構的討論可能涉及如何快速為患者提供這種有效的治療方案。而且未來的發展計劃不僅僅是在更大的範圍內更快地發展，而是對第二線或前線進行更大的研究，正如 Ameet 所提到的。當然，關於劑量是多少還有討論，其他類似的事情也可以納入討論。因此，實際上，採取這項行動的時機取決於數據以及我們的後續行動，我們與該機構進行了富有成效的討論。

Yes. And in terms of the data update we shared later this year, we haven't disclosed if it will be a company update or medical congress. Obviously, we want to share as much data as we can. And so as you know, that's one of the considerations is the data cutoff sometimes for medical congresses are much, much earlier. And so that's one of the things we're considering in that choice of how we can make sure that we can show a robust update that goes beyond what we shared in June.

是的。至於我們今年稍後分享的數據更新，我們尚未透露它是公司更新還是醫學大會。顯然，我們希望共享盡可能多的數據。如您所知，其中一個考慮因素是，醫學大會的數據截止日期有時要早得多。因此，這是我們正在考慮的事情之一，我們如何確保能夠展示超越我們在六月所分享內容的強大更新。

Got it thank you.

明白了，謝謝。

Leonid Timashev, RBC Capital Markets.

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

Yeah, thanks, for taking my question. I just want to ask on some of the indolent lymphoma. I guess, given the encouraging MZL data you've seen, can you just remind us how you see ZYNLONTA fitting into these more indolent indications given that there's slightly different benefit-risk calculus there. And then what you're thinking the bar is for NCCN inclusion in these indolent lymphomas, both in terms of what you'd want to show an efficacy and also the number of patients and then maybe just a quick follow-up on that. I guess, would you also consider looking at bispecific combos in these. Thanks.

是的，謝謝你回答我的問題。我只是想問一些關於惰性淋巴瘤的問題。我想，鑑於您所看到的令人鼓舞的 MZL 數據，您能否提醒我們，考慮到那裡的收益風險計算略有不同，您如何看待 ZYNLONTA 適應這些更為惰性的適應症。然後，您認為 NCCN 將這些惰性淋巴瘤納入的標準是什麼，無論是從您想要顯示的療效還是患者數量來看，然後可能只是對此進行快速跟進。我想，您是否也會考慮研究其中的雙特異性組合。謝謝。

Yes. So yes, I agree. We are very encouraged by the indolent lymphoma data we've generated both in the relapsed-refractory setting of MZL and follicular. Specific to your question around MZL, there's the study that's ongoing, the Phase II IIT is expected to enroll 50 patients. We think that number is clearly sufficient because when you look at the numbers, actually the last compound that was added to NCCN guidelines was pirtobrutinib, which is a BTK inhibitor based on 36 patients. The most -- any trial has ever enrolled, which is clinical trial is about 62 patients. So we think 50 is about the right number. We're well on our way to enrolling that number of patients.

是的。是的，我同意。我們在復發難治性 MZL 和濾泡性淋巴瘤中產生的惰性淋巴瘤數據令我們感到非常鼓舞。具體到您關於 MZL 的問題，目前有一項研究正在進行中，第二階段 IIT 預計將招募 50 名患者。我們認為這個數字顯然足夠了，因為當你查看數字時，實際上添加到 NCCN 指南中的最後一種化​​合物是吡托替尼，它是一種基於 36 名患者的 BTK 抑製劑。這是迄今為止臨床試驗中招募最多的患者，約有 62 名患者。所以我們認為 50 是一個合適的數字。我們正在順利招募到這麼多的患者。

In terms of what you need to show, right now, when you look at the CR rates in that relapsed-refractory setting, the highest CR is about 29%. So we're well above that, obviously, with the data we're sharing right now. Clearly, I think 40% or above would be significant improvement over any of the standard of care. In terms of risk benefit, which is one of the other things you mentioned, we're really pleased about the safety profile right now that we're seeing with ZYNLONTA.

就您現在需要展示的內容而言，當您查看復發難治性環境中的 CR 率時，最高 CR 約為 29%。因此，根據我們現在分享的數據，顯然我們已經遠高於這個數字。顯然，我認為 40% 或以上對於任何護理標準來說都是顯著的改善。就風險收益而言，這是您提到的另一件事，我們對目前看到的 ZYNLONTA 的安全性感到非常滿意。

At this point, we don't see the need to combine with the bispecific because we're seeing such high efficacy with a single agent and particularly in the indolent lymphomas, thinking about the safety profile for knowing the patients can be treated and can be on treatment and in a disease setting for multiple years, oftentimes, the tolerability profile is obviously much more important than even a more aggressive lymphomas like DLBCL. So we feel quite comfortable with our approach as a single agent ZYNLONTA in marginal zone lymphoma, and that's the approach we'll take going forward.

目前，我們認為沒有必要與雙特異性藥物聯合使用，因為我們看到單一藥物具有如此高的療效，特別是在惰性淋巴瘤中，考慮到了解患者可以接受治療並且可以接受治療並在疾病環境中多年的安全性，通常，耐受性特徵顯然比 DLBCL 等更具侵襲性的淋巴瘤更為重要。因此，我們對使用 ZYNLONTA 單一藥物治療邊緣區淋巴瘤的方法感到非常滿意，這也是我們今後將採取的方法。

(Operator Instructions)

（操作員指示）

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

Congrats on strong progress in the quarter. First, can you walk us through your sales force growth plan and time line as you expect to unlock a much larger TAM with the strong response data outcomes with the LOTIS trials? How will marketing responsibilities of combination with glofitamab be split, if any at all with Roche? And when do you anticipate the earliest opportunity the MS cells will have to start talking about the LOTIS trial data to prescribing physicians?

恭喜本季取得巨大進展。首先，您能否向我們介紹一下您的銷售隊伍成長計畫和時間表，因為您期望透過 LOTIS 試驗的強勁反應數據結果來解鎖更大的 TAM？如果有的話，與 glofitamab 組合的營銷責任將如何與羅氏分擔？您預計 MS 細胞最早什麼時候有機會開始與開處方的醫生討論 LOTIS 試驗數據？

And then lastly, real quick, post the CRL of STARGLO, do you anticipate SKYGLO confirmatory Phase III study is granted for approval for the glofitamab plus Pola-R-CHP combo changed the landscape for treatment of second-line DLBCL akin to how we'll fit plus GemOx was expected to or be more of the same?

最後，快速地發布 STARGLO 的 CRL，您是否預計 SKYGLO 確認性 III 期研究將獲得批准，因為 glofitamab 加 Pola-R-CHP 組合會改變二線 DLBCL 治療的格局，類似於我們預期的 GemOx 或將有更多相同之處？

Okay. So you asked a few different questions. One was around the commercial and medical affairs approach, that we're going to use. Two, you said is there going to be any collaboration with Roche on that? And then three, you asked a little bit about SKYGLO and then SKYGLO would be the confirmatory study. So let's answer each of those questions. From a field force and medical affairs standpoint, we think we have the right footprint. We're already -- if you look at our commercial footprint, we're covering 90% of the potential of DLBCL. So we think we're well covered in that setting. Similarly, if you look at our MSL force, it's very competitive where we're able to cover all the academic centers and all the large community centers.

好的。所以你問了幾個不同的問題。一個是圍繞商業和醫療事務的方法，我們將採用這種方法。第二，您說在這方面是否會與羅氏合作？第三，你問了一些關於 SKYGLO 的問題，那麼 SKYGLO 就是一項確認性研究。那麼讓我們來回答每一個問題。從現場人員和醫療事務的角度來看，我們認為我們已經擁有正確的足跡。如果您看一下我們的商業足跡，您會發現我們已經涵蓋了 DLBCL 的 90% 潛力。因此我們認為我們在那種環境下已經做好了充分的準備。同樣，如果你看看我們的 MSL 隊伍，你會發現它非常有競爭力，我們能夠涵蓋所有的學術中心和所有大型社區中心。

So we think our footprint is where it needs to be. Obviously, we would add some resources on the marketing and medical side as you would, prelaunch and in the early launch basis as we kind of expand the potential use of ZYNLONTA. With regards to any collaboration, as you know, we'll be launching, we believe, with a successful approval of LOTIS-5, we would be then promoting that and be successfully launching that. LOTIS-7 is a bit different because what we expect the first step to be is in compendia. And as you know, we won't promote anything off-label.

因此我們認為我們的足跡就在需要的地方。顯然，我們會像您一樣在行銷和醫療方面增加一些資源，在產品發布前和早期發佈時，我們會擴大 ZYNLONTA 的潛在用途。關於任何合作，如您所知，我們相信，隨著 LOTIS-5 的成功批准，我們將推動並成功啟動它。LOTIS-7 有點不同，因為我們預計第一步是在彙編中。如您所知，我們不會推廣任何非說明書規定的產品。

And so our commercial teams won't be actively discussing LOTIS-7. MSLs, obviously, will be there to respond to questions that physicians have around the LOTIS-7 data. And at this point, there's no planned collaboration commercially and medically with Roche on that.

因此我們的商業團隊不會積極討論 LOTIS-7。顯然，MSL 將會回答醫師有關 LOTIS-7 資料的問題。目前，我們還沒有與羅氏就此進行商業和醫學合作的計劃。

With regards to the frontline study with glofit, Pola-R-CHP, it's hard to know. We're -- we don't want to speculate beyond what Roche has said, obviously. I think their intention is that, that could be the confirmatory study, but we're waiting like you are to see if that gets confirmed by the FDA.

關於 glofit、Pola-R-CHP 的第一線研究，很難知道。顯然，我們不想對羅氏所說的內容進行進一步的猜測。我認為他們的意圖是，這可能是一項確認性研究，但我們和您一樣正在等待，看看是否能得到 FDA 的確認。

There are no further questions at this time, I will now turn the call over to Ameet for closing remarks.

目前沒有其他問題，現在我將把電話交給 Ameet 做結束語。

Well, I want to thank you all for joining our call today and for your continued support. We look forward to keeping you updated on our progress operator, you may now end the call.

好吧，我想感謝大家今天參加我們的電話會議並感謝你們一直以來的支持。我們期待隨時向您通報我們的進度，您現在可以結束通話了。

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating in us that you please disconnect your lines.

女士們、先生們，今天的電話會議到此結束。感謝您參與我們的活動，請斷開您的線路。