ADC Therapeutics SA (ADCT) 2024 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the ADC Therapeutics' first quarter 2024 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Nicole Riley, Head of Communications. Please go ahead.

美好的一天，感謝您的支持。歡迎參加 ADC Therapeutics 2024 年第一季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的發言人、通訊主管妮可·賴利 (Nicole Riley)。請繼續。

Thank you operator. This morning, we issued a press release announcing our first quarter 2024 financial results and business update. This release is available on the ADCT website at ir.adctherapeutics.com under the Press Releases section. The event is being recorded and the slides accompanying this call are available on the ADCT website at ir.adctherapeutics.com under the Latest Events and Presentations section.

謝謝運營商。今天上午，我們發布新聞稿，宣布 2024 年第一季財務業績和業務更新。此新聞稿可在 ADCT 網站 ir.adctherapeutics.com 的新聞稿部分取得。活動正在錄製中，本次電話會議附帶的幻燈片可在 ADCT 網站 ir.adctherapeutics.com 的「最新活動和簡報」部分下找到。

On today's call, Ameet Mallik, Chief Executive Officer; and Pepe Carmona, Chief Financial Officer, will discuss recent business highlights, and review our first quarter 2024 financial results. We will then open the call to questions when we will be joined by Kristen Harrington-Smith, Chief Commercial Officer; and Mohamed Zaki, Chief Medical Officer.

在今天的電話會議上，執行長阿米特馬利克 (Ameet Mallik) 表示：財務長佩佩·卡莫納 (Pepe Carmona) 將討論最近的業務亮點，並回顧我們 2024 年第一季的財務業績。然後，我們將開始提問，首席商務官克里斯汀·哈林頓·史密斯 (Kristen Harrington-Smith) 也將加入我們的行列；和首席醫療官穆罕默德扎基。

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.

在我們開始之前，我想提醒聽眾，本次電話會議期間所做的一些陳述將包含 1995 年美國私人證券訴訟改革法案安全港條款含義內的前瞻性陳述。

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 on slide 3 and in the company's filings with the SEC, including Forms 10-K, 10-Q and 8-K.

這些前瞻性陳述受到某些已知和未知的風險和不確定性的影響。實際結果表現和成就可能有重大差異。它們在幻燈片 3 隨附的幻燈片簡報以及公司向 SEC 提交的文件（包括表格 10-K、10-Q 和 8-K）中進行了識別和描述。

ADCT is providing this information as of the date of today's conference call 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 after the date hereof, except as required by law or otherwise. The company cautions investors not to place undue reliance on these forward-looking statements.

ADCT 截至今天的電話會議之日提供此信息，並且不承擔因本次會議日期之後的新信息、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義務，除非有要求根據法律或其他方式。該公司警告投資者不要過度依賴這些前瞻性陳述。

Today's presentation also includes non-GAAP financial measures. These non-GAAP measures have limitations as financial measures and should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the information contained in the company's fourth quarter earnings release for definitional 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指標。這些非公認會計原則措施作為財務措施有局限性，應作為根據公認會計原則準備的資訊的補充，而不是孤立地考慮或作為其替代。您應該參考公司第四季度收益發布中包含的信息，以了解歷史非公認會計準則衡量指標與可比公認會計準則財務衡量指標的定義信息和調節表。

It is now my pleasure to pass the call over to our CEO Ameet Mallik. Ameet?

現在我很高興將電話轉接給我們的執行長 Ameet Mallik。阿米特？

Thanks, Nicole, and thank you all for joining us today. As you will see, we have shared some very exciting news items earlier this morning. But to begin with, I'd like to focus on key business updates for the quarter.

謝謝妮可，也謝謝大家今天加入我們。正如您將看到的，我們今天早上分享了一些非常令人興奮的新聞。但首先，我想專注於本季的關鍵業務更新。

Starting with our commercial performance, ZYNLONTA continued its return to sequential growth with revenues of $17.8 million in Q1. This represents a 7% increase over the fourth quarter of 2023. Importantly, we saw continued growth both in the community and in academic centers despite the intensified competitive landscape.

從我們的商業業績開始，ZYNLONTA 繼續恢復環比成長，第一季營收達到 1,780 萬美元。這比 2023 年第四季成長了 7%。重要的是，儘管競爭格局加劇，但我們看到社區和學術中心都在持續成長。

Turning next to our pipeline, we have made significant progress. Last month, we announced that our LOTIS-7 study of ZYNLONTA in combination with bispecifics successfully cleared the final dosing cohort in both arms with no dose-limiting toxicities. No I can't say either no or low grade levels of CRS.

談到我們的管道，我們已經取得了重大進展。上個月，我們宣布 ZYNLONTA 與雙特異性藥物聯合的 LOTIS-7 研究成功清除了雙臂的最終劑量組，且沒有劑量限制性毒性。不，我不能說 CRS 沒有或等級低。

We are now dose expanding at 120 and 150 micrograms per kilogram in this amount plus glofit about combination arm in [2L+ DLBCL]. Today, we are delighted to share for the first time encouraging initial data recently presented from the University of Miami's Phase 2 investigator initiated trial of ZYNLONTA in relapsed refractory marginal zone lymphoma. Based on initial results from the first 15 evaluable patients, 13 achieved a complete response and 1 achieved a partial response with all patients maintaining response at the time of data cutoff.

我們現在將劑量擴大到每公斤 120 和 150 微克，加上合併用藥組的 glofit[2L+ DLBCL]。今天，我們很高興首次分享邁阿密大學 2 期研究人員最近提交的令人鼓舞的初步數據，該數據啟動了 ZYNLONTA 治療復發難治性邊緣區淋巴瘤的試驗。根據前 15 名可評估患者的初步結果，13 名患者獲得完全緩解，1 名患者獲得部分緩解，所有患者在數據截止時均保持緩解。

Moving to ADCT-601, our novel AXL targeting ADC. We began enrolling pancreatic cancer patients and continue to enroll sarcoma patients, and we are in the process of optimizing the dose and schedule.

轉向 ADCT-601，我們的新型 AXL 靶向 ADC。我們開始招募胰臟癌患者，並繼續招募肉瘤患者，我們正在優化劑量和時間表。

Lastly, we shared a comprehensive update on our novel exatecan-based solid tumor platform, including early preclinical data on our four preclinical ADC candidates for the first time at our recent research investor event.

最後，我們在最近的研究投資者活動中首次分享了基於 exatecan 的新型實體瘤平台的全面更新，包括我們的四種臨床前 ADC 候選藥物的早期臨床前數據。

Finally, in terms of our corporate update, we maintained our disciplined capital allocation strategy and decreased operating expenses in Q1 by 16% year-over-year on a non-GAAP basis. This in turn enabled us to manage our cash burn so that we ended the first quarter with cash of $234.3 million. On top of this, we have just announced today that we have priced an underwritten offering to raise $105 million in gross proceeds. The offering at the closing price per share on Friday included common shares and prefunded warrants and is expected to close on May 8. We expect this will extend our cash runway into mid 2026 and provide the company with enhanced financial flexibility to execute our strategy.

最後，在我們的公司更新方面，我們維持了嚴格的資本配置策略，並在非 GAAP 基礎上將第一季的營運費用比去年同期減少了 16%。這反過來又使我們能夠管理現金消耗，第一季末我們的現金為 2.343 億美元。除此之外，我們今天剛宣布，我們已經為一項承銷發行定價，籌集總收益 1.05 億美元。此次發行以週五每股收盤價計算，包括普通股和預融資認股權證，預計將於 5 月 8 日結束。我們預計這將把我們的現金跑道延長至 2026 年中期，並為公司提供更強的財務靈活性來執行我們的策略。

Given our strength and balance sheet. I would like to remind everyone of the strategy we are pursuing, which we believe will unlock the tremendous value we see in the company. Our first pillar and primary focus remains hematology. Within this, we have a derisked asset in ZYNLONTA. The key product in our prioritized portfolio, which we expect to carry the company through to profitability.

鑑於我們的實力和資產負債表。我想提醒大家我們正在追求的策略，我們相信這將釋放我們在公司看到的巨大價值。我們的第一個支柱和主要關注點仍然是血液學。其中，我們有 ZYNLONTA 的去風險資產。我們優先投資組合中的關鍵產品，我們希望該產品能幫助公司獲利。

We are deploying the majority of our capital to this month of franchise to commercialize our existing 3L+ DLBCL indication and to pursue the substantially larger potential opportunity in earlier lines of DLBCL therapy and indolent lymphomas. Such as marginal zone lymphoma. We believe these potential opportunities will help expand this amount of franchise and have the potential to generate annual peak sales in excess of $0.5 billion.

我們將在本月的特許經營中部署大部分資金，以將我們現有的 3L+ DLBCL 適應症商業化，並在早期 DLBCL 治療和惰性淋巴瘤系列中尋求更大的潛在機會。如邊緣區淋巴瘤。我們相信這些潛在機會將有助於擴大特許經營數量，並有可能產生超過 5 億美元的年度高峰銷售額。

The second pillar of our strategy is grounded in our emerging solid tumor pipeline. ADCT-601 is our most advanced asset. Behind this we see the potential to advance our broad portfolio of differentiated ADCs against solid tumor targets of interest driven by our novel exatecan-based platform.

我們策略的第二個支柱立足於我們新興的實體腫瘤產品線。ADCT-601 是我們最先進的資產。在這背後，我們看到了在我們基於 exatecan 的新型平台的驅動下，針對感興趣的實體瘤靶點推進我們廣泛的差異化 ADC 產品組合的潛力。

I'd like to expand now on the substantially larger potential opportunity for ZYNLONTA. In earlier lines of DLBCL therapy and indolent lymphomas. Pending the results of the LOTIS-5 and LOTIS-7 studies, our goal is to expand usage of ZYNLONTA into 2L+ DLBCL. As a reminder LOTIS-5 is our confirmatory Phase 3 study of ZYNLONTA in combination with rituximab. Here, we remain on track and expect to complete enrollment by the end of this year with the potential for a [headline readout] by the end of 2025.

我現在想談談 ZYNLONTA 更大的潛在機會。在早期 DLBCL 治療和惰性淋巴瘤中。在等待 LOTIS-5 和 LOTIS-7 研究結果之前，我們的目標是將 ZYNLONTA 的使用範圍擴大到 2L+ DLBCL。提醒一下，LOTIS-5 是我們 ZYNLONTA 與利妥昔單抗合併用藥的驗證性 3 期研究。在這裡，我們仍按計劃進行，預計在今年年底前完成註冊，並有可能在 2025 年底前完成[頭條新聞]。

Is positive, we believe this trial will lead to full approval for the month and expand our indication into 2L+ DLBCL in combination with rituximab potentially as early as the end of 2026. LOTIS-7 is our Phase 1b trial of ZYNLONTA in combination with bispecifics. We are encouraged by the initial safety and tolerability profile as well as the observed antitumor activity amongst the majority of patients in Part 1 of the dose escalation.

正面的結果是，我們相信這項試驗將在本月獲得全面批准，並可能最早在 2026 年底將我們的適應症擴大到與利妥昔單抗聯合治療 2L+ DLBCL。LOTIS-7 是我們 ZYNLONTA 與雙特異性藥物聯合的 1b 期試驗。我們對最初的安全性和耐受性概況以及在劑量遞增第 1 部分中在大多數患者中觀察到的抗腫瘤活性感到鼓舞。

We are now enrolling and Part 2 dose expansion with ZYNLONTA possible glofitamab in 2L+ DLBCL and expect to complete enrollment and plan to share additional efficacy and safety data before year end. We also see the potential to expand the uses ZYNLONTA into the [2L+] setting the [follicular] lymphoma and marginal zone lymphoma based on initial data from investigator initiated trials at the University of Miami.

我們現在正在入組和第 2 部分中使用 ZYNLONTA 可能的 glofitamab 治療 2L+ DLBCL 進行劑量擴展，並預計完成入組併計劃在年底前分享額外的療效和安全性數據。根據邁阿密大學研究者發起的試驗的初步數據，我們也看到了將 ZYNLONTA 的用途擴展到 [2L+] 設定 [濾泡] 淋巴瘤和邊緣區淋巴瘤的潛力。

Today, I want to focus on the marginal zone lymphoma data that was shared this past weekend at the Lymphoma Research Foundation's 2024 marginal zone lymphoma scientific workshop by the trial's lead investigator Dr. [Isidor losos] at the University of Miami. Relapsed refractory MZL represents an unmet need based on publicly available incidence data. There are an estimated 3,000 to 4,000 2L+ MZL patients who are drug treated in the US. Unmet medical need remains in relapsed refractory MZL for less than 30% CR for second-line plus approved or NCCN preferred treatments.

今天，我想重點關注上週末在淋巴瘤研究基金會 2024 年邊緣區淋巴瘤科學研討會上由邁阿密大學的試驗首席研究員 [Isidor losos] 博士分享的邊緣區淋巴瘤數據。根據公開的發病率數據，復發難治性 MZL 代表了未滿足的需求。據估計，美國有 3,000 至 4,000 名 2L+ MZL 患者正在接受藥物治療。對於二線加核准的或 NCCN 首選治療的 CR 低於 30% 的複發難治性 MZL ，仍有未滿足的醫療需求。

At present, there are two FDA approved regimens and several other preferred regimens for the treatment of MZL second line plus included in NCCN guidelines. Complete response rates are modest and sample sizes in the study supporting this data are relatively small. As complete response rates are a strong predictor of time related outcomes and MZL clinicians continue to seek novel agents with higher and durable CR rates, a manageable safety profile and a fixed duration of treatment.

目前，NCCN 指南中有兩種 FDA 批准的 MZL 二線治療方案和其他幾種首選方案。完全緩解率較低，支持此數據的研究樣本量相對較小。由於完全緩解率是時間相關結果的有力預測因素，MZL 臨床醫生繼續尋找具有更高且持久的 CR 率、可控安全性和固定治療持續時間的新型藥物。

The University of Miami is leading a multicenter Phase 2 IIT studying ZYNLONTA as a single agent fixed duration regimen to treat 50 [ZYNLONTA] refractory MZL patients. Initial data from the first 15 evaluable patients showed 13 achieved a complete response and 1 achieved a partial response. According to the lead investigator, ZYNLONTA was generally well tolerated and safety was consistent with the known profile.

邁阿密大學正在領導一項多中心 2 期 IIT 研究 ZYNLONTA 作為單藥固定療程方案來治療 50 名 [ZYNLONTA] 難治性 MZL 患者。前 15 名可評估患者的初步數據顯示，13 名患者獲得完全緩解，1 名患者獲得部分緩解。據首席研究員稱，ZYNLONTA 整體耐受性良好，安全性與已知情況一致。

There are two sites currently enrolling University of Miami and City of Hope, and the lead investigator is currently expanding to five sites to accelerate trial enrollment. As soon as we have sufficient data, assuming it remains positive, we plan to potentially pursue our regulatory pathway and compendia strategy in parallel.

目前，邁阿密大學和希望之城有兩個試驗點正在招募，首席研究員目前正在擴大到五個試驗點，以加快試驗招募速度。一旦我們獲得足夠的數據，假設它仍然是正面的，我們計劃潛在地同時推行我們的監管途徑和概要策略。

In terms of the opportunity based on [r/r] analysis, we believe the total addressable 2L+ MZL patient population as a potential peak market opportunity of approximately $500 million valued at ZYNLONTA price and an expected average number of cycles. If successful, it means every 10% of market share captured represents $50 million in incremental annual peak sales opportunity. While still early in the phase 2 IIT is this trial continues to yield similar results. The potential opportunity to expand in MZL could contribute to the overall market growth strategy in NHL.

就基於 [r/r] 分析的機會而言，我們認為可尋址的 2L+ MZL 患者群體總數是一個潛在的峰值市場機會，以 ZYNLONTA 價格和預期平均週期數計算，其價值約為 5 億美元。如果成功，這意味著每佔 10% 的市佔率就代表著 5,000 萬美元的增量年度高峰銷售機會。儘管 IIT 仍處於第二階段的早期階段，但該試驗仍繼續產生類似的結果。MZL 擴張的潛在機會可能有助於 NHL 的整體市場成長策略。

The current standard of care in MZL includes CD20 based regimens across all lines. In addition to BTK inhibitors in second-line MZL. The data used for FDA approvals and inclusion in NCCN guidelines were based on either single arm studies or a subset of larger indolent NHL studies and offer modest CR rates, which are below 30%.

MZL 目前的護理標準包括所有系列中基於 CD20 的治療方案。另外二線MZL中還有BTK抑制劑。FDA 批准和納入 NCCN 指南所使用的數據是基於單臂研究或大型惰性 NHL 研究的子集，並提供適度的 CR 率，低於 30%。

[Per the] study protocol. All patients included must have failed one or more lines of systemic therapy, including at least one anti-CD20 antibody. Under the protocol, patients receive a fixed duration of treatment of six cycles of ZYNLONTA across 18 weeks. The primary endpoint is CR rate at 6 and 12 months, and patients will be followed for up to three years with progression-free survival and overall survival measured at 24 months. The predetermined futility threshold for efficacy was set at 31% CR rate.

[根據]研究方案。納入的所有患者必須已接受過一種或多種全身性治療，包括至少一種抗 CD20 抗體。根據該方案，患者接受為期 18 週、六個週期的固定 ZYNLONTA 治療。主要終點是 6 個月和 12 個月時的 CR 率，患者將被追蹤長達三年，並在 24 個月時測量無惡化存活期和總存活期。預定的療效無效閾值設定為 31% CR 率。

Looking at the baseline characteristics of the patients enrolled so far in the study, there are a few things I want to point out. We believe this initial group of patients is representative of the overall MZL population, including MZL subtypes. In addition of the patients treated with ZYNLONTA so far, 10 of the 15 were staged for MZL patients with 8 of the 15 designated as POD24, meaning they progress within 24 months of initial treatment, a group that is typically harder to treat.

縱觀迄今為止參與研究的患者的基線特徵，我想指出一些事情。我們相信這最初的一組患者代表了整個 MZL 族群，包括 MZL 亞型。除了迄今為止接受ZYNLONTA 治療的患者外，這15 名患者中有10 名進行了MZL 患者分期，其中15 名患者中的8 名被指定為POD24，這意味著他們在初始治療後24 個月內出現進展，這一組通常更難治療。

The median prior lines of therapy is two, ranging from one to four. And as you could see on the right side of the slide included multiple currently available systemic treatments. As shared by Dr. Loses at the Lymphoma Research Foundation's 2024 marginal zone lymphoma scientific workshop on May 4. These initial results showed 13 out of 15 patients achieved CR with one additional patient achieving a PR. Out of the 13 CRs 9 were achieved after two cycles.

先前治療的中位數為 2 線，範圍從 1 到 4 線不等。正如您在幻燈片右側看到的那樣，包括多種目前可用的全身性治療方法。正如 Loses 博士於 5 月 4 日在淋巴瘤研究基金會 2024 年邊緣區淋巴瘤科學研討會上分享的那樣。這些初步結果顯示，15 名患者中有 13 名獲得 CR，另外一名患者獲得 PR。13 個 CR 中有 9 個是在兩個週期後實現的。

In addition, all patients achieving responses and maintain them as of the data cutoff with the longest responder reaching approximately 20 months. And from an initial safety perspective per the lead investigator in this study, ZYNLONTA was generally well tolerated and consistent with the known safety profile. One patient discontinued after Cycle 2, second patient discontinued after Cycle 4 due to a toxicity which fully resolved upon discontinuation of treatment. Both of these patients remain in CR at 10 at six months, respectively.

此外，截至數據截止時，所有患者均獲得緩解並維持緩解，其中最長的緩解時間達到約 20 個月。從本研究主要研究者的初步安全角度來看，ZYNLONTA 整體耐受性良好，並且與已知的安全性一致。一名患者在第 2 週期後停藥，第二名患者在第 4 週期後停藥，原因是毒性在停止治療後完全消失。這兩名患者分別在 10 個月時仍處於 CR 狀態。

Based on this initial data from University of Miami Phase 2 trial evaluating ZYNLONTA in relapsed refractory MZL, we are encouraged by the potential opportunity in the second-line plus setting for patients with this rare disease.

根據邁阿密大學評估 ZYNLONTA 治療復發難治性 MZL 的 2 期試驗的初步數據，我們對這種罕見疾病患者在二線+治療中的潛在機會感到鼓舞。

Moving that LOTIS-7 we are sharing here additional safety data from the part one dose escalation portion of the study. The important takeaways are that the majority of CRS events were Grade 1 and that no CRS greater than Grade 2 is observed. Those patients who have experienced a Grade 2 CRS were managed with no requirement for ICU management or processors.

關於 LOTIS-7，我們在此分享來自該研究第一部分劑量遞增部分的額外安全資料。重要的結論是，大多數 CRS 事件都是 1 級，並且沒有觀察到大於 2 級的 CRS。那些經歷過 2 級 CRS 的患者無需 ICU 管理或處理人員即可得到管理。

On the left-hand side, you will see that the overall CRS rate with Loncastuximab was 33%, which is the combination of focus for part two of this study. Important to note, the current Loncastuximab label in 3L+ DLBCL includes a 70% CRS rate including some higher grade events. We believe that dosing with ZYNLONTA one-week prior to Loncastuximab, it may be debulking the tumor.

在左側，您將看到 Loncastuximab 的整體 CRS 率為 33%，這是本研究第二部分的重點組合。值得注意的是，目前 Loncastuximab 在 3L+ DLBCL 中的標籤包括 70% 的 CRS 率，其中包括一些更高級別的事件。我們認為，在 Loncastuximab 之前一周服用 ZYNLONTA 可能會縮小腫瘤。

Turning to our research platform, we hosted our Virtual Investor Research event on April 9, which provided a comprehensive overview of our solid tumor research strategy. Our novel exatecan-based platform and our four lead ADC candidates. Our focus is on advancing differentiated ADC candidates against prostate, Non-small cell lung cancer, colorectal, endometrial and ovarian cancers for each tumor type.

談到我們的研究平台，我們於 4 月 9 日舉辦了虛擬投資者研究活動，全面概述了我們的實體腫瘤研究策略。我們新穎的基於 exatecan 的平台和我們的四個領先 ADC 候選藥物。我們的重點是針對每種腫瘤類型開發針對前列腺癌、非小細胞肺癌、大腸直腸癌、子宮內膜癌和卵巢癌的差異化 ADC 候選藥物。

The combination of incidence and 5-year survival offers large potential opportunities and indicates that better treatment options are needed. Furthermore, in each case, chemotherapy remains a key part of the treatment armamentarium. Our four lead ADC targets are NaPi2b, Claudin-6, PSMA and ASCT2.

發病率和 5 年存活率的結合提供了巨大的潛在機會，並表明需要更好的治療選擇。此外，在每種情況下，化療仍然是治療手段的關鍵部分。我們的四個主要 ADC 標靶是 NaPi2b、Claudin-6、PSMA 和 ASCT2。

We believe each offers the potential to improve the standard of care for cancer patients and each utilizes our novel exatecan-based platform. Preclinical work suggests that our four lead candidates each have a high therapeutic index, reflecting the proprietary design of the ADC. In terms of stage are NaPi2b Claudin-6 ADCs are in IND-enabling studies and we are pleased to share exciting early data. And these are [AICR] last month. Our PSMA and ASCT2 ADCs are in the drug candidate selection stage, which we expect to complete this year.

我們相信，每個項目都有可能提高癌症患者的護理標準，並且每個項目都利用我們基於 exatecan 的新型平台。臨床前工作表明，我們的四個主要候選藥物均具有較高的治療指數，反映了 ADC 的專有設計。就階段而言，NaPi2b Claudin-6 ADC 正處於 IND 啟用研究中，我們很高興分享令人興奮的早期數據。這些是上個月的 [AICR]。我們的 PSMA 和 ASCT2 ADC 正處於候選藥物篩選階段，預計今年完成。

So looking ahead, we plan to move forward with one candidate to IND and to seek research collaborations to advance our broad portfolio. Given the unmet medical need, coupled with the market opportunity. A successful outcome for one or more of our early research programs has the potential to transform the lives of patients and create significant value in the future.

因此，展望未來，我們計劃將一名候選人推進 IND 並尋求研究合作以推進我們廣泛的產品組合。鑑於未滿足的醫療需求，加上市場機會。我們的一個或多個早期研究計畫的成功結果有可能改變患者的生活並在未來創造重大價值。

With that, I would like to turn the call over to Pepe.

說到這裡，我想把電話轉給佩佩。

Thank you, Ameet. Before, I discuss today's financing, I will take you through a brief summary of our first quarter results. As a reminder, we're now reporting our results under US GAAP we became a US domestic filer as of January 1, 2024.

謝謝你，阿米特。在討論今天的融資之前，我先帶大家簡單總結一下我們第一季的表現。提醒一下，我們現在根據美國公認會計原則報告我們的結果，我們自 2024 年 1 月 1 日起成為美國國內申報者。

Starting with our balance sheet. At March 31, we had cash and cash equivalents approximately $234.3 million. Moving to the P&L, as you already shared with Internet sales were $17.8 million in the quarter, a decrease of 6% versus prior year, primarily driven by higher gross-to-net deductions and lower volume, partially offset by higher gross [prices].

從我們的資產負債表開始。截至 3 月 31 日，我們的現金和現金等價物約為 2.343 億美元。轉向損益表，正如您已經分享的那樣，該季度的互聯網銷售額為1,780 萬美元，比去年同期下降6%，這主要是由於總淨額扣除額增加和銷量減少（部分被總銷售額增加所抵消）[價格]。

On a sequential basis in long-term, net sales grew 7% versus the fourth quarter of [2023]. Our total operating expenses on a non-GAAP basis, which excludes stock-based compensation, were down 16% compared to the first quarter of last year. This mainly reflected our focus on driving operating efficiencies together with reduced R&D expenditures due to focus investment in our clinical studies and lower selling and marketing expense.

從長期來看，淨銷售額比第四季成長了 7%[2023]。我們以非公認會計準則計算的總營運費用（不包括以股票為基礎的薪資）與去年第一季相比下降了 16%。這主要反映了我們對提高營運效率的關注，以及由於對臨床研究的重點投資以及較低的銷售和行銷費用而減少的研發支出。

For 2024, we will continue to take a very disciplined approach to our capital. You can find a reconciliation of GAAP measures to non-GAAP measures in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation.

2024 年，我們將繼續對我們的資本採取非常嚴格的態度。您可以在今天稍早發布的新聞稿所附的財務表格以及本簡報的附錄中找到 GAAP 衡量標準與非 GAAP 衡量標準的調整表。

Moving to the bottom of the P&L. GAAP basis, we reported a net loss of $46.6 million for the quarter or $0.56 per basic and diluted share. On a non-GAAP basis, adjusted net loss was $31.1 million. Adjusted net loss of $0.38 per basic and diluted share.

移動到損益表的底部。根據 GAAP 計算，我們報告本季淨虧損 4,660 萬美元，即每股基本虧損和稀釋每股虧損 0.56 美元。以非公認會計準則計算，調整後淨虧損為 3,110 萬美元。調整後每股基本和攤薄淨虧損為 0.38 美元。

The decreasing both reported and adjusted net loss compared with the first quarter of 2023 was primarily due to lower operating expenses. Today, we have announced the pricing of a registered direct offering which included pre-funded warrants. We expect to close by May 8, and the offering is expected to raise approximately $105 million of gross proceeds.

與 2023 年第一季相比，報告和調整後淨虧損均有所下降，主要是由於營運費用下降。今天，我們宣布了包括預先融資認股權證在內的註冊直接發行的定價。我們預計將於 5 月 8 日結束，此次發行預計將籌集約 1.05 億美元的總收益。

We have been delighted by the response from a range of high-quality institutional investors. And we expect the proceeds to extend our cash runway into the middle of 2026. By strengthening our balance sheet we believe we are now better find us to pursue our corporate strategy.

我們對一系列高品質機構投資者的反應感到高興。我們預計所得收益將把我們的現金跑道延長到 2026 年中期。透過加強我們的資產負債表，我們相信我們現在可以更好地追求我們的企業策略。

So reminder, hematology continues to be the primary focus of our capital allocation. And within this, our key objective is to create value by expanding the use of ZYNLONTA beyond the current indication. We expect to achieve this by fully support our commercialization efforts in the US directly to our partnerships ex-US. And by investing behind potential expansion into earlier lines of DLBCL and indolent lymphomas.

因此提醒一下，血液學仍然是我們資本配置的主要重點。其中，我們的主要目標是透過將 ZYNLONTA 的用途擴展到當前適應症之外來創造價值。我們希望透過直接全力支持我們在美國的商業化努力以及我們在美國以外的合作夥伴關係來實現這一目標。並投資於早期 DLBCL 和惰性淋巴瘤系列的潛在擴張。

And solid tumors. Our aim is to pursue multiple ADC candidates in parallel and increase our shots on goal mainly to our novel exatecan-based research plan. We'll determine on a case-by-case basis whether we wish to progress candidates internally or seek partner in order to share the development of financial costs.

還有實體瘤。我們的目標是並行追求多個 ADC 候選者，並主要根據我們新穎的基於 exatecan 的研究計劃增加我們的射門次數。我們將根據具體情況決定是希望在內部晉升候選人還是尋求合作夥伴以分擔開發的財務成本。

As Ameet mentioned earlier, we intend to take at least one candidate forward to R&D. And the new funds raised give us a continued freedom to do so. My final slide highlights the multiple potential value-driving milestones, which we expect in the coming year. Importantly, we have delivered on our promises to date in [2024] with positive updates for some long-time LOTIS-7 study and MZL IITs clinical trial.

正如阿米特之前提到的，我們打算將至少一名候選人帶到研發部門。新籌集的資金使我們能夠繼續自由地這樣做。我的最後一張投影片強調了我們預計在未來一年實現的多個潛在價值驅動里程碑。重要的是，我們已經兌現了迄今為止在 [2024] 年的承諾，並對一些長期 LOTIS-7 研究和 MZL IITs 臨床試驗進行了積極更新。

With the initiation of dosing of ADCT-601 in pancreatic cancer, with the disclosure of our existing new research platform at our Virtual Investor Research firm. In the second half of this year, we have multiple potential value generating catalysts, including expected completion of enrollment in LOTIS-5 initial efficacy and safety data from LOTIS-7 Part 2 expansion initial read of ADCT-601, and AXL in bone sarcoma and pancreatic cancer.

隨著 ADCT-601 開始在胰臟癌中給藥，以及我們虛擬投資者研究公司現有的新研究平台的揭露。In the second half of this year, we have multiple potential value generating catalysts, including expected completion of enrollment in LOTIS-5 initial efficacy and safety data from LOTIS-7 Part 2 expansion initial read of ADCT-601, and AXL in bone sarcoma and胰腺癌.

With that, I will turn the call back to Ameet.

這樣，我會將電話轉回給 Ameet。

Thanks, Pepe. To conclude my team and I are very proud of our performance in the first quarter of 2024. We achieved another quarter of sequential growth was ZYNLONTA. We delivered against each of the plan, key research and development milestones, and we maintained our disciplined approach to capital allocation.

謝謝，佩佩。總而言之，我和我的團隊對 2024 年第一季的表現感到非常自豪。ZYNLONTA 又實現了一個季度的連續成長。我們兌現了每項計畫、關鍵研發里程碑，並維持了嚴格的資本分配方法。

Looking ahead with a strengthened balance sheet and enhanced financial flexibility to execute our strategy. I am confident that ADC Therapeutics is well positioned to drive value creation for all of our stakeholders.

展望未來，我們將透過強化資產負債表和增強財務靈活性來執行我們的策略。我相信 ADC Therapeutics 處於有利位置，能夠為我們所有利害關係人創造價值。

With that, operator, could you please could you please begin the Q&A session.

那麼，接線員，請您開始問答環節。

Kelly Shi, Jefferies.

施凱莉，傑弗里斯。

Hi, good morning. This is Joe for Kelly. And thanks very much for taking the question and congratulations on the marginal zone lymphoma data. I believe you reported very positive data from the follicular lymphoma program where investigators initiate the study at [ASH]? And so can you remind us your plan for follicular lymphoma and compared to marginal zone lymphoma? And which one do you think could potentially be maybe we see the potential or enter sponsored study first. And have you received any feedback in terms of the safety considering that indolent lymphoma patients? Thank you.

早安.這是凱利的喬。非常感謝您提出問題，並對邊緣區淋巴瘤數據表示祝賀。我相信您報告了濾泡性淋巴瘤計畫的非常積極的數據，研究人員在該計畫中啟動了這項研究[灰]？那麼您能否提醒我們您對濾泡性淋巴瘤的計劃以及與邊緣區淋巴瘤的比較？您認為哪一個可能是我們可能看到的潛力或首先進入贊助研究。考慮到惰性淋巴瘤患者的安全性，您是否收到過任何回饋？謝謝。

Yeah, no, thanks for the question. I think you're right to say that we were excited to share data in an oral presentation last ASH on the relapsed refractory follicular lymphoma population, which showed that the combinations and multiplus Loncastuximab had an overall response rate of 96% and a CR rate of 85% with a manageable safety tolerability profile.

是的，不，謝謝你的提問。我認為你說得對，我們很高興在上次ASH 的口頭報告中分享關於復發難治性濾泡性淋巴瘤人群的數據，該數據表明聯合用藥和多聯Loncastuximab 的總體緩解率為96%， CR 率為85% 具有可控的安全耐受性。

So I think that was really encouraging data, of course, now seeing the marginal zone lymphoma data and another into lymphoma with, again, high overall response rate, high CR rates. And again, a manageable safety profile. We're really encouraged. Both of these trials are have been expanded. So the follicular lymphoma patient study will now be 100 patients marginal zone now be 50 patients, both our multi-center studies as well. And with both of them, we plan to pursue both the regulatory strategy as well as the compendia strategy in parallel, based on the outcome of the data.

所以我認為這確實是令人鼓舞的數據，當然，現在看到邊緣區淋巴瘤數據和另一個淋巴瘤數據，再次具有高總體緩解率和高 CR 率。再次，可管理的安全性設定檔。我們真的很受鼓舞。這兩項試驗均已擴大。因此，濾泡性淋巴瘤患者的研究現在將是 100 名患者，邊緣區現在是 50 名患者，這都是我們的多中心研究。對於這兩種策略，我們計劃根據數據結果並行實施監管策略和概要策略。

The one thing to note about the follicular data that's important is that it's really just go after the high risk patient population. We know that when you go after all comers and follicular lymphoma, there is a precedence for randomized Phase 3 studies and long follow-up. We're focused on a narrower population, which is a high-risk population most of which were POD24. And we think that the data looks good. There may be a faster pathway, potentially either through a regulatory pathway or through guidelines in that more narrow patient population.

關於卵泡數據需要注意的一件事很重要，那就是它實際上只是針對高風險患者群體。我們知道，當您追尋所有的來者和濾泡性淋巴瘤時，優先考慮隨機 3 期研究和長期追蹤。我們關注的是一小部分人群，這是一個高風險人群，其中大多數是 POD24。我們認為數據看起來不錯。可能存在更快的途徑，可能透過監管途徑或針對更狹窄的患者群體的指南。

MZL is probably even more straightforward because if you look at the majority of -- you look at everything, it's been approved either by the FDA or in guidelines, they've been approved based on either single arm studies for subsets of larger randomized studies in indolent lymphoma studies. And typically with somewhere between 40 to 70 patients. So we think the 50 patient study we're running it.

MZL 可能更直接，因為如果你看看大多數——你看看所有的東西，它要么得到了FDA 的批准，要么在指南中得到了批准，它們是基於單臂研究的較大隨機研究的子集而獲得批准的。通常有 40 到 70 名患者。所以我們認為我們正在進行 50 名患者的研究。

In an appropriate size and based on the data maturity from this study, we again will pursue guidelines and regulatory pathway in parallel. So that I would say is that the even more straightforward pathway because there's so much precedents and MZL. But we also think just given the strength of the data, have a really interesting opportunity in follicular as well.

以適當的規模並根據本研究的數據成熟度，我們將再次並行追求指南和監管途徑。所以我想說的是，這是更直接的途徑，因為有很多先例和 MZL。但我們也認為，鑑於數據的強度，卵泡也有一個非常有趣的機會。

Great, thank you.

太好了謝謝。

Michael Schmidt, Guggenheim.

邁克爾·施密特，古根漢。

(inaudible) guys, thanks for taking my questions. And yes, super interesting update here at MZL obviously, I think you said all of the patients are still in an response. Could you just help us contextualize that the duration a little bit, what do we know about the duration of benefit for other drug in MZL and how does that compare to that?

（聽不清楚）夥伴們，感謝您提出我的問題。是的，MZL 的更新顯然非常有趣，我想您說過所有患者仍在做出反應。您能否幫助我們稍微了解一下持續時間，我們對 MZL 其他藥物的獲益持續時間了解多少，以及與此相比如何？

And then yeah, I think you did have this one patient discontinued due to toxicity. Can you just comment on what that was? And then I had follow up. Thanks.

是的，我認為您確實讓一位患者因毒性而停藥。你能評論一下那是什麼嗎？然後我進行了跟進。謝謝。

Yeah, thanks, Michael. We're yeah, as you said, we're really encouraged by the data as well. And also in MZL confirming what we've seen and follicular and what we've seen in other areas, the safety profile has been really good. We haven't seen any new safety signals at any of the sites. So that's been encouraging. But I'm going to turn to Mohamed to talk about both the duration that's seen in other treatments and what we would want to see here.

是的，謝謝，邁克爾。是的，正如您所說，我們也對這些數據感到鼓舞。而且在 MZL 中確認了我們所看到的卵泡以及我們在其他區域所看到的情況，安全狀況非常好。我們還沒有在任何地點看到任何新的安全信號。所以令人鼓舞。但我要請穆罕默德談談其他治療中看到的持續時間以及我們希望在這裡看到的情況。

Yes. Thanks, Michael. First, I want to highlight that one of the patients with CR radiation 20 months, many of the patients have currently are more than 10 months and all our own goal, you are correct at the time of [Danica]. What has been reported in the literature, it's smaller trials and range between possibly 15 and 18 months. Those are the PFS that has been reported for the ability within either single agents or in combining.

是的。謝謝，麥可。首先，我想強調的是，其中一位患者接受了 20 個月的 CR 放射治療，許多患者目前已經超過 10 個月，而且都是我們自己的目標，您當時是正確的[丹妮卡]。根據文獻報告，試驗規模較小，持續時間可能在 15 到 18 個月之間。這些是已通報的單一藥物或組合藥物的 PFS。

So if the data maintains it the way it is and the responses are continuing for all the patients that we have seen. You have 13 out of 16 CR, 1 PR. We believe we'll be in a very good place in terms of their entities. But again, talk about your ability to [earlier platform].

因此，如果數據保持原樣，並且我們見過的所有患者的反應都會持續下去。16 項中有 13 項 CR，1 項 PR。我們相信，就他們的實體而言，我們將處於非常有利的位置。但再一次，談談你的能力[早期平台]。

[Gentleman] my second question was around the one patient with toxicity we don't have more details, the investigators planning as there, but sample size increases and the duration and follow-up increases to do a much bigger presentation at a more major medical congress where, if you will share all the data does want to compromise that.

[先生]我的第二個問題是關於一名患有毒性的患者，我們沒有更多細節，研究人員正在計劃，但樣本量增加，持續時間和隨訪時間增加，以便在更重要的醫學上做更大的介紹國會，如果你願意分享所有數據，確實會損害這一點。

So what we know from the investigator is one patient had a toxicity discontinued at after Cycle 4 that patient was already in CR once the patient was discontinued for toxicity fully resolved. And that patient still remains at CR now that patients six months out. So that's what we know the other than we understand from the investigators, everything they've seen across all 15 patients. The safety profile is consistent with the known safety profile of ZYNLONTA.

因此，我們從研究者得知，一名患者在第 4 週期後停止了毒性反應，一旦該患者因毒性完全解決而停藥，則該患者已處於 CR 狀態。這名患者在六個月後仍處於 CR 狀態。這就是我們從研究人員那裡了解到的情況之外的情況，即他們在所有 15 名患者中看到的一切。安全性與 ZYNLONTA 已知的安全性一致。

Great, awesome. Super interesting. And then a question I noticed and I know you had some really early Phase 1 data at [HCR] and but just wanted to know if you could provide some visibility on the next update. I think you have another look at our data in the second half of this year and then more in the first half of next year as well.

太棒了，太棒了。超有趣。然後我注意到一個問題，我知道您在 [HCR] 上有一些非常早期的第一階段數據，但只是想知道您是否可以提供有關下一次更新的一些可見性。我想你們今年下半年會再看一下我們的數據，明年上半年也會再看一下。

Yeah, so we yeah, we are now in Part 2 dose expansion right now. We are quite pleased, I think with the dose escalation, how smoothly it went and our dose expansion. Looking at ZYNLONTA plus [Loncastuximab] second line plus DLBCL patients, we're looking at the two different doses ZYNLONTA 150 microgram per kilogram dose as well as the 120 microgram per kilogram dose, both in combination with the full doses of [glofitamab].

是的，所以我們是的，我們現在正在進行第二部分劑量擴展。我認為我們對劑量的增加、進展的順利程度以及劑量的擴大感到非常滿意。觀察 ZYNLONTA 加 [Loncastuximab] 二線加 DLBCL 患者，我們正在研究兩種不同劑量的 ZYNLONTA 150 微克每公斤劑量以及 120 微克每公斤劑量，兩者均與全劑量組合[格洛非他瑪]。

We are expect to complete the enrollment of roughly 20 patients in each of those dosing cohorts by the end of this year. And then we will share the safety and efficacy data that's available for all evaluable patients. And what we mean by that is patients who have had at least a 12-week scan because obviously any responses we want to make sure are confirmed. So that will be likely a subset of those 40 patients that are actually available at that time. We will share all the data that's available by the end of the year and then provide an even more comprehensive update in the first half of next year when we have data from all 40 patients, including longer follow-up.

我們預計今年底將完成每個劑量組中約 20 名患者的入組。然後我們將分享所有可評估患者可用的安全性和有效性數據。我們的意思是至少接受過 12 週掃描的患者，因為顯然我們想要確保的任何反應都得到證實。因此，這可能是當時實際可用的 40 名患者的一部分。我們將在今年年底之前共享所有可用數據，然後在明年上半年獲得所有 40 名患者的數據（包括更長的追蹤）後提供更全面的更新。

Great, super helpful. And then lastly LOTIS-5 funds a year well, on track to complete enrolling here later this year. And just curious if you had any additional visibility on the event rate coming in and the timing on the primary now. Thanks so much.

太棒了，超級有幫助。最後，LOTIS-5 一年的資金狀況良好，預計在今年稍後完成註冊。只是好奇您是否對進入的事件發生率以及現在主要的時間有任何額外的了解。非常感謝。

Yeah. I mean, as you said, and I'll turn it to Mohamed to comment further, but we're on track to complete the study. The enrollment pace has picked up quite a bit over the course of this past year and even this year in particular has picked up quite a bit. So we're confident in completing the enrollment of the study this year. It's an event-driven trial, so you can never predict the ones going to exactly read out. But based on our current thinking, we believe it may read out as soon as the end of 2025, which if that's the case, and that's positive, could lead to an approval as soon as the end of 2026.

是的。我的意思是，正如您所說，我會將其交給穆罕默德進一步評論，但我們正在按計劃完成這項研究。在過去的一年裡，入學速度已經加快了許多，尤其是今年。所以我們有信心完成今年的研究招生。這是一個事件驅動的試驗，因此您永遠無法預測哪些試驗會準確讀出。但根據我們目前的想法，我們認為最早可能會在 2025 年底公佈，如果是這樣的話，而且這是積極的，那麼最快可能會在 2026 年底獲得批准。

But Mohamed, you want to comment more on the enrollment and what you're seeing with LOTIS-5

但是 Mohamed，您想對註冊情況以及您在 LOTIS-5 中看到的情況發表更多評論

Yeah. We're very pleased with the current enrollment. It picked up strongly during 2023 and 2025 really is who we are. It's still in, I believe that we will be able to enroll the study here, things are moving very well. Also we have a DMC that meets regularly that have cleared the study multiple times, no changes. So that's a very positive sign.

是的。我們對目前的入學情況感到非常滿意。它在 2023 年和 2025 年強勁回升，這就是我們的本質。還在，我相信我們一定能在這裡報名學習，事情進展得很順利。我們還有一個定期開會的 DMC，已多次批准研究，沒有任何變更。所以這是一個非常積極的跡象。

In addition, I would like to say that the events are being reviewed by independent central review. So that's another very key element for us to make sure that those are confirmed and done completely independent. As you know, we're blinded, but it's event-driven study. And I think until that next year, that's a positive thing. And hopefully that would have been the case. So that's pretty much all of our staff at the moment.

此外，我想說的是，這些事件正在接受獨立中央審查。因此，這是我們確保這些內容完全獨立確認和完成的另一個非常關鍵的因素。如您所知，我們是盲目的，但這是事件驅動的研究。我認為直到明年，這是一件積極的事情。希望情況確實如此。這幾乎就是我們目前的所有員工。

Yeah, I think on track thus far, we feel good about the progress, and we're well on track to complete this year.

是的，我認為到目前為止，我們已經步入正軌，我們對進展感到滿意，並且我們有望順利完成今年的任務。

Great. Well, thanks so much. Congrats on the update today.

偉大的。嗯，非常感謝。恭喜今天更新。

Thank you.

謝謝。

Thank you.

謝謝。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎（Gregory Renza），加拿大皇家銀行資本市場部。

Hi, this is [support] on for Greg, thank you so much for taking our questions and congrats on the progress. A lot of questions on the competitive dynamics from CD20 bispecifics. Have number one, has the impact been fully realized the impact of the competition from CD20 bispecific antibodies or has it been fully realized in the third-line setting?

大家好，這是格雷格的[支持]，非常感謝您回答我們的問題並祝賀我們取得的進展。關於 CD20 雙特異性抗體的競爭動態有許多問題。第一，CD20雙特異性抗體競爭的影響是否已完全實現，或已在三線環境中完全實現？

And now the [Roche] recently announced that the trial in a second lights have hit the timing endpoints and, you know, could potentially be ahead of ZYNLONTA combination from LOTIS-5. I'm just curious, how should we think about the competition uniform from that come by CD20 bispecific combo of to LOTIS-5? Thank you so much.

現在，[Roche] 最近宣布，第二盞燈的試驗已達到計時終點，您知道，可能會領先 LOTIS-5 的 ZYNLONTA 組合。我只是很好奇，我們該如何看待 CD20 雙特異性組合與 LOTIS-5 的比賽服？太感謝了。

Yeah, that's a great question. Here the bispecifics, we have both of the approved bispecifics in the 3L+ DLBCL setting are definitely getting uptake primarily in the academic center. We see much more limited use in the community. So in the academic center. There is quite a bit of use of bispecifics post CAR-T. I think importantly, we still have seen some modest growth, though in the academic centers overall in our volume when you look at Q4 to Q1. What that's been driven with is while you have some lower level of depth in some centers that were using ZYNLONTA quite a bit in [that setting]. We've actually seen a higher amount of breadth of centers and academic centers that are using their pocket.

是的，這是一個很好的問題。這裡的雙特異性藥物，我們在 3L+ DLBCL 環境中擁有兩種已批准的雙特異性藥物，肯定主要在學術中心被採用。我們看到社區中的使用更加有限。所以在學術中心。CAR-T 後雙特異性抗體的使用相當多。我認為重要的是，我們仍然看到了一些適度的增長，儘管從第四季度到第一季來看，學術中心的整體數量有所增長。造成這種情況的原因是，雖然某些中心的深度水平較低，但這些中心大量使用 ZYNLONTA[那個設定]。事實上，我們已經看到越來越多的中心和學術中心在利用自己的口袋。

So in essence, we've been able to basically compensate for a lot of that competitive impact, although it's real. I mean, bispecifics are definitely being used quite a bit and you could see it in their growth rates a lot in that third-line plus post CAR-T acting -- in the academic setting.

因此，從本質上講，我們基本上已經能夠彌補許多競爭影響，儘管它是真實存在的。我的意思是，雙特異性藥物肯定被大量使用，你可以在第三線以及 CAR-T 後的學術環境中看到它們的成長率。

So we've felt the competitive impact. I think importantly, though, we've been able to largely offset at an academic center and we see continued growth in the community as well. So we think our strategy is working. In terms of the data around that the [glofitamab] [genmab's] combination. [Well to look] we have to wait and see the data actually, it hasn't been published. They give a top-line result. I mean, one thing of note, I think it's just that they said that the -- I think I want to pay attention to is what's the toxicity profile.

所以我們已經感受到了競爭的影響。但我認為重要的是，我們已經能夠在很大程度上抵消學術中心的影響，我們也看到社區的持續成長。所以我們認為我們的策略正在發揮作用。就 [glofitamab] [genmab] 組合的數據而言。 [好吧看看]實際上我們還得等等看數據，它還沒有公佈。他們給出了最重要的結果。我的意思是，值得注意的一件事是，我認為他們只是說——我想我想關注的是毒性概況。

We don't know. But obviously using systemic chemo with a bispecific, you want to see what the toxicity profile looks like. I think there we feel quite confident, I think, in our combinations, both ZYNLONTA plus rituximab as well as ZYNLONTA plus [Loncastuximab]. Given the toxicity profiles we've seen there. So I think as you move into second line, it's important to have strong efficacy and a manageable safety tolerability profile. We feel confident in both of our approaches.

我們不知道。但顯然，使用具有雙特異性的全身性化療，您想看看毒性概況是什麼樣的。我認為我們對我們的組合非常有信心，無論是 ZYNLONTA 加利妥昔單抗還是 ZYNLONTA 加[龍卡妥昔單抗]。鑑於我們在那裡看到的毒性特徵。因此，我認為當您進入二線時，擁有強大的功效和可管理的安全耐受性非常重要。我們對我們的兩種方法都充滿信心。

I don't have much to add. I mean, again, we're excited to see the Star load data that will be out at EHA and as Ameet said, we've been able to hold share pretty much in the academic centers. We see that despite the bispecifics, we have strong advocacy in the academic centers. And what we also hear is that these advocates recommends ZYNLONTA to the community treaters, which is critical. Once we see the data from LOTIS-5, the briefing is the best estimate is probably one of the most commonly used agents out there with a lot of familiarity of between LOTIS-5 and LOTIS-7, we offer free optionality with ZYNLONTA.

我沒有太多要補充的。我的意思是，我們很高興看到將在 EHA 發布的 Star 加載數據，正如 Ameet 所說，我們已經能夠在學術中心佔據相當大的份額。我們看到，儘管存在雙特異性，但我們在學術中心擁有強而有力的倡議。我們也聽到的是，這些倡導者向社區治療人員推薦 ZYNLONTA，這一點至關重要。一旦我們看到 LOTIS-5 的數據，簡報就是最好的估計，它可能是最常用的代理之一，對 LOTIS-5 和 LOTIS-7 之間有很多熟悉，我們提供 ZYNLONTA 的免費選項。

Yeah, it's a really, really important point that Kristen just made. One of the most predominant uses. We know that CAR-T is only used in about 20% of patients second line. Really in the academic center, the majority of patients in academic centers are getting it. In the community, though our base chemo regiments are very, very commonly used. So we think it's our base ADC approach. It's going to fit really well there.

是的，克里斯汀剛剛提出的這一點非常非常重要。最重要的用途之一。我們知道，CAR-T僅用於約20%的第二線患者。事實上，在學術中心，學術中心的大多數患者都得到了它。在社區中，儘管我們的基礎化療方案非常非常常用。所以我們認為這是我們的基本 ADC 方法。它會非常適合那裡。

Got it. Thank you so much.

知道了。太感謝了。

Brian Cheng, JPMorgan.

布萊恩鄭，摩根大通。

Hey, guys, thanks for taking our question this morning. Maybe just a first question on LOTIS-7. Can you talk a little bit more about the strategy beyond those expansion in LOTIS-7? Will there be a need to run the larger second-line pivotal study to get to officially move into the bispecific -- move and was the bispecific combo? And if yes, how do you think about the study design and the timing and I have a follow-up. Thank you.

嘿，夥計們，感謝您今天早上提出我們的問題。也許只是關於 LOTIS-7 的第一個問題。能多談談 LOTIS-7 中擴充以外的策略嗎？是否需要進行更大規模的二線關鍵研究才能正式進入雙特異性藥物—移動並且是雙特異性組合？如果是，您如何看待研究設計和時間安排，我有一個後續行動。謝謝。

Okay. Yeah, thanks, Brian. Great question. I'm going to hand it to Mohamed to answer the question on LOTIS-7.

好的。是的，謝謝，布萊恩。很好的問題。我將把它交給 Mohamed 來回答有關 LOTIS-7 的問題。

Yeah, thanks, Brian. This is [stick] wise. First, we'd like to see how the efficacy in the combination second line plus looks like and how it compares in the competitive environment. And definitely we are looking to see how the safety profile is looking like. We're very pleased that we cleared all doses and see that when we get to the point with the two doses that we're expanding the depth and persist.

是的，謝謝，布萊恩。這是[堅持]明智的。首先，我們想看看二線+組合的功效如何，以及它在競爭環境中的比較。當然，我們希望了解安全狀況如何。我們很高興我們清除了所有劑量，並看到當我們達到兩個劑量的程度時，我們正在擴大深度並堅持下去。

We're definitely planning to have a conversation with the regulators about the possibility of a Phase 3 approval there. The -- at that time, we will see what the comparator are impact would be. However, that could be interesting is the best choice as you I'm sure you're aware of because there are multiple agents and many things could be available at that time. But for us, it's going to be a data-driven approach and the composition of the agency is given to tell us more about that.

我們肯定計劃與監管機構就第三階段批准的可能性進行對話。到那時，我們將看到比較器的影響是什麼。然而，這可能是有趣的，因為我相信你知道這是最好的選擇，因為有多個代理，並且當時可以使用很多東西。但對我們來說，這將是一種數據驅動的方法，而該機構的組成可以告訴我們更多相關資訊。

Okay. And then maybe second one on for [pay]. Can you give us a better sense on how you define commercial brand profitability this year? Is this factory and only cost of goods sold and selling and marketing expense? Or is there additional consideration coming from our G&A expense as well? Thank you.

好的。然後也許是第二個[支付]。您能否讓我們更了解您如何定義今年商業品牌的獲利能力？這家工廠只有銷售成本以及銷售和行銷費用嗎？還是我們的一般管理費用也有額外的考量？謝謝。

Yeah, thanks for the question, Brian. So this year, as in long-term we'll be able to pay for all the direct and commercialization effort. That includes all the sales force MSLs, the AMP that we invest in the product, the IIPs that we are -- have been executing. And on top of that, obviously cost of goods and [payoff] and [whatso]. So that -- it doesn't -- what it doesn't include is the pipeline. So our LOTIS-5 and LOTIS-7 trial and a corporate G&A that is not included.

是的，謝謝你的提問，布萊恩。因此，今年，從長遠來看，我們將能夠支付所有直接和商業化工作的費用。這包括所有銷售人員 MSL、我們投資於產品的 AMP、我們一直在執行的 IIP。最重要的是，顯然，商品成本和[回報]和[那又怎樣]。所以——它不——它不包括管道。因此，我們的 LOTIS-5 和 LOTIS-7 試驗以及企業一般管理費用不包括在內。

Okay, great. Thank you.

好的，太好了。謝謝。

Thank you. And I am showing no further questions from our phone lines. And I'd like to turn the conference back over to Ameet Mallik for any closing remarks.

謝謝。我的電話線路上沒有再提出任何問題。我想將會議轉回給阿米特·馬利克（Ameet Mallik）發表閉幕詞。

Thank you very much for joining our call today, and thank you for your continued support. We look forward to keeping you updated on our progress. Have a very nice day, everyone. Thank you.

非常感謝您今天加入我們的電話會議，並感謝您一如既往的支持。我們期待向您通報我們的最新進展。祝大家有個愉快的一天。謝謝。

This concludes today's conference call. Thank you for your participation and you may now disconnect. Everyone, have a wonderful day.

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。祝大家有美好的一天。