Summit Therapeutics Inc (SMMT) 2025 Q3 法說會逐字稿

Thank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Summit Therapeutics Q3 2025 earnings and ESMO data update call. (Operator Instructions)

感謝您的支持。我叫凱特，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Summit Therapeutics 2025 年第三季財報和 ESMO 數據更新電話會議。（操作員指示）

I would now like to turn the call over to Dave Gancarz. Please go ahead.

現在我想把電話轉給 Dave Gancarz。請繼續。

Good day, and thank you for joining us. We issued a press release on Friday morning regarding the expansion of our Phase III clinical development programs, unveiling the global Phase III study in first-line colorectal cancer.

您好，感謝您加入我們。我們在周五早上發布了一份關於擴大我們的 III 期臨床開發計劃的新聞稿，公佈了針對一線結直腸癌的全球 III 期研究。

Yesterday, we issued a press release relating to the Phase III HARMONi-6 data featuring ivonescimab, presented as a part of the Presidential Symposium at the European Society for Medical Oncology's 2025 Congress, otherwise known as ESMO 2025. The HARMONi-6 study was conducted in China, sponsored by our partners at Akeso. All relevant data was exclusively generated, managed, and analyzed by Akeso.

昨天，我們發布了一份新聞稿，涉及 ivonescimab 的 III 期 HARMONi-6 數據，該數據是作為歐洲腫瘤內科學會 2025 年大會（也稱為 ESMO 2025）主席研討會的一部分進行的。HARMONi-6 研究在中國進行，由我們的合作夥伴康方生物贊助。所有相關數據均由康方生物獨家生成、管理和分析。

And finally, this morning, we announced our intention to submit a BLA this quarter for ivonescimab based on the results of the HARMONi study, as well as expand our Phase III study plan, with additional color to be provided in the first quarter.

最後，今天上午，我們宣布了我們打算根據 HARMONi 研究的結果在本季度提交 ivonescimab 的 BLA，並擴展我們的 III 期研究計劃，並在第一季度提供更多資訊。

Additionally, on today's call, we will provide an update on our third-quarter financial results and operational progress. Press releases are available on our website, www.smmttx.com. Our Form 8-K and Form 10-Q were also filed today and are available on our website and via the SEC's website. Today's call is being simultaneously webcast, and an archived replay will be made available later today on our website.

此外，在今天的電話會議上，我們將提供有關第三季財務業績和營運進展的最新資訊。新聞稿可在我們的網站 www.smmttx.com 上查閱。我們的 8-K 表格和 10-Q 表格也已於今日提交，可在我們的網站和美國證券交易委員會 (SEC) 網站上查閱。今天的電話會議將同時進行網路直播，存檔重播將於今天晚些時候在我們的網站上提供。

Joining me on the call today is Bob Duggan, our Chairman of the Board and Co-Chief Executive Officer; Dr. Maky Zanganeh, our Co-Chief Executive Officer and President; Manmeet Soni, our Chief Operating Officer and Chief Financial Officer; Dr. Urte Gayko, our Chief Regulatory, Quality, and Safety Officer; Dr. Allen Yang, our Head of R&D Strategy; Dr. Jack West, our VP of Clinical Development; and Dr. Fong Clow, our Chief Biometrics Officer.

今天與我一起參加電話會議的還有我們的董事會主席兼聯席首席執行官 Bob Duggan、我們的聯席首席執行官兼總裁 Maky Zanganeh 博士、我們的首席運營官兼首席財務官 Manmeet Soni、我們的首席監管、質量和安全官 Urte Gayko 博士、我們的研發戰略主管 Allen Yang 博士、我們的臨床開發副總​​裁 Jack West 博士以及我們的首席生物識別官 Fong Clow 博士。

Before we get started with the rest of the call, I would like to note that some statements made by our management team and some responses to questions that we make today may be considered forward-looking statements based on our current expectations.

在我們開始電話會議的其餘部分之前，我想指出，我們的管理團隊所做的一些聲明以及我們今天對一些問題的回答可能被視為基於我們當前預期的前瞻性陳述。

Summit cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Please refer to our SEC filings for information about these risks and uncertainties. Summit undertakes no obligation to update these forward-looking statements, except as required by law.

Summit 警告稱，這些前瞻性陳述受風險和不確定性的影響，可能導致實際結果與前瞻性陳述中所示的結果有重大差異。有關這些風險和不確定性的信息，請參閱我們的 SEC 文件。除非法律要求，Summit 不承擔更新這些前瞻性聲明的義務。

One item of note, this presentation is being webcast with slides. So we'll be referring to information on these slides being displayed in the webcast link. I'd encourage you to use the webcast link to see these slides being presented this morning that will accompany our comments. And these slides are also available on our website. Following comments from our team, we will take questions.

值得注意的是，該演示正在透過幻燈片進行網路直播。因此，我們將參考網路廣播連結中顯示的這些幻燈片的資訊。我鼓勵您使用網路廣播連結來觀看今天上午與我們的評論一起展示的幻燈片。這些幻燈片也可以在我們的網站上找到。根據我們團隊的評論，我們將回答問題。

With that, I would like to hand it over to Jack to walk through the beginning of the presentation.

接下來，我想把演講的開始交給傑克。

Thank you, David. Yesterday, as you're aware, ivonescimab data was featured in the presentation at ESMO 2025 as part of the Presidential Symposium. The presentation titled, Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer HARMONi-6 was given by Dr. Shun Lu, MD, PhD; Chief of Shanghai Lung Cancer Center in Shanghai Chest Hospital; Professor of Medicine at Shanghai Jiaotong University; and Associate Editor for the Journal of Thoracic Oncology.

謝謝你，大衛。昨天，如您所知，ivonescimab 數據在 ESMO 2025 總統研討會的演示中進行了展示。報告題為“ivonescimab 聯合化療與 tislelizumab 聯合化療作為晚期鱗狀非小細胞肺癌一線治療的 III 期研究 HARMONi-6”，由醫學博士、哲學博士陸順博士發表，他是上海市胸科醫院上海肺癌中心主任、上海交通大學醫學教授、《胸部腫瘤雜誌》副主編。

Revisiting the schema for the HARMONi-6 trial, this study evaluated ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer irrespective of PD-L1 expression.

重新檢視 HARMONi-6 試驗的方案，本研究評估了 ivonescimab 聯合鉑類化療與 PD-1 抑制劑 tislelizumab 聯合鉑類化療治療局部晚期或轉移性鱗狀非小細胞肺癌患者的療效，無論 PD-L1 表達如何。

HARMONi-6 is a single-region, multicenter Phase III study conducted in China sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. Key eligibility criteria are shown here.

HARMONi-6 是一項由康方生物贊助在中國進行的單區域、多中心 III 期研究，所有相關數據均由康方生物獨家生成、管理和分析。關鍵資格標準如下所示。

Patients were randomized 1:1, stratified by stage cancer and PD-L1 tumor expression at base line. Patients received either ivonescimab at 20 milligrams per kilogram plus carboplatin paclitaxel or tislelizumab plus carboplatin paclitaxel for up to four cycles, and then received either ivonescimab or tislelizumab as maintenance therapy for up to 24-months.

患者按 1:1 隨機分組，根據癌症分期和基線 PD-L1 腫瘤表現進行分層。患者接受 20 毫克/公斤的 ivonescimab 加卡鉑紫杉醇或 tislelizumab 加卡鉑紫杉醇治療，最多四個週期，然後接受 ivonescimab 或 tislelizumab 作為維持治療，最多 24 個月。

Treatment was to be discontinued for intolerability, progressive disease, or initiation of new antitumor therapy. The study's single, primary endpoint was progression-free survival by independent radiologic review committee. Secondary endpoints included response rate, duration of response, safety, and overall survival.

由於無法耐受、病情進展或開始新的抗腫瘤治療而停止治療。研究的唯一主要終點是獨立放射學審查委員會確定的無惡化存活期。次要終點包括反應率、反應持續時間、安全性和整體存活率。

The trial included a total of 532 patients. Baseline characteristics show that this was a predominantly male population, nearly all with Stage IV disease. And it's important to underscore that these patients with advanced squamous non-small cell lung cancer included those with characteristics that we have traditionally considered as potentially associated with bleeding on anti-angiogenic therapies.

本試驗共納入 532 名患者。基線特徵顯示，該族群以男性為主，幾乎全部患有 IV 期疾病。需要強調的是，這些晚期鱗狀非小細胞肺癌患者包括那些具有我們傳統上認為可能與抗血管新生療法出血相關的特徵的患者。

Specifically, approximately two-thirds had a central tumor, 17% had encasement of major blood vessels in the chest, 9% had tumor cavitation, and nearly one in three had a history of some hemoptysis. The breakdown of PD-L1 expression showed approximately 40% had a PD-L1-negative cancer, with the remaining 60% of PD-L1-positive cancers showing 40% in the low range of 1% to 49% and about 20% with high PD-L1 expression of 50% or greater.

具體來說，約三分之二的患者有中央腫瘤，17％的患者胸部主要血管被包裹，9％的患者有腫瘤空洞，近三分之一的患者有咯血病史。PD-L1 表達的細分顯示，約 40% 患有 PD-L1 陰性癌症，其餘 60% 的 PD-L1 陽性癌症中，40% 的 PD-L1 表達處於 1% 至 49% 的低範圍內，約 20% 的 PD-L1 表達為 50% 或更高。

The figure for progression-free survival by independent radiologic review committee curve and analysis shows the trial was positive for the primary endpoint, with the hazard ratio of 0.60 and a corresponding p-value of less than 0.0001.

獨立放射學審查委員會的無惡化存活曲線和分析數據表明，該試驗對主要終點呈陽性，風險比為 0.60，相應的 p 值小於 0.0001。

Median progression-free survival was 11.14 months for the ivonescimab-plus-chemotherapy arm, compared to 6.90 months for those patients receiving tislelizumab plus chemotherapy, a difference of 4.2 months favoring the ivonescimab-plus-chemotherapy arm. PFS by investigator assessment showed a consistent hazard ratio of 0.64.

ivonescimab 合併化療組的中位無惡化存活期為 11.14 個月，而接受 tislelizumab 合併化療的患者為 6.90 個月，ivonescimab 合併化療組患者有 4.2 個月的差異。研究者評估的 PFS 顯示風險比一致為 0.64。

When we look at various subgroups, it's important to highlight that the size of the subgroups are smaller by definition and not designed to show statistically significant on their own, but they can be informative. The subgroup analysis for progression-free survival confirms benefit in all preplanned subgroups as indicated by point estimates for each subgroup landing on the left side of the dividing line favoring ivonescimab, overall showing that the study results were observed broadly and not driven by a specific subset or subsets of patients.

當我們觀察不同的子群時，需要強調的是，子群的規模從定義上來說較小，並且不是為了顯示統計顯著性而設計的，但它們可以提供資訊。無惡化存活期的亞組分析證實了所有預先計劃的亞組均有獲益，正如每個亞組的點估計值落在有利於 ivonescimab 的分界線左側所表明的那樣，總體而言，表明研究結果是廣泛觀察到的，而不是由特定的一個或多個患者亞組驅動的。

These progression-free survival curves show the benefit in patients with negative, low, and high PD-L1 expression, representing PD-L1 TPS score less than 1%, 1% to 49%, and 50% or more respective at baseline. Patients with negative PD-L1 tumor expression had a hazard ratio of 0.55. Those with low tumor PD-L1 expression had a hazard ratio of 0.63. And those with high tumor PD-L1 expression had a hazard ratio of 0.71.

這些無惡化存活曲線顯示了 PD-L1 表達陰性、低和高的患者的益處，分別代表基線時 PD-L1 TPS 評分低於 1%、1% 至 49% 和 50% 或更多。PD-L1 腫瘤表達陰性的患者風險比為 0.55。 PD-L1 腫瘤表達低的患者風險比為 0.63。 PD-L1 腫瘤表達高的患者風險比為 0.71。

In other words, ivonescimab demonstrated benefit relative to tislelizumab across the entire spectrum of tumor PD-L1 expression. Objective response rate, irrespective of PD-L1 expression, was improved for ivonescimab by an absolute difference of 9.4%.

換句話說，ivonescimab 在整個腫瘤 PD-L1 表達範圍內表現出相對於 tislelizumab 的益處。無論 PD-L1 表現如何，ivonescimab 的客觀緩解率均提高了 9.4%。

In patients with PD-L1 expression less than 1% and those with PD-L1 expression of 1% or greater, objective response rate were improved for ivonescimab by an absolute difference of 8.5% and 9.9%, respectively. The median duration of response was also improved from 8.4 months for tislelizumab plus chemotherapy to 11.2 months for ivonescimab plus chemotherapy.

在 PD-L1 表達低於 1% 的患者和 PD-L1 表達為 1% 或更高的患者中，ivonescimab 的客觀緩解率分別提高了 8.5% 和 9.9%。中位緩解持續時間也從替雷利珠單抗合併化療的 8.4 個月改善至伊沃內西單抗合併化療的 11.2 個月。

Treatment-related adverse events showed only a small increase in the ivonescimab group. Any great events were 99.2% versus 98.5%. And serious treatment-related adverse events were 32.3% versus 30.2% in the ivonescimab and tislelizumab arms, respectively. Treatment-related adverse events leading to discontinuation of ivonescimab plus chemotherapy or tislelizumab plus chemotherapy occurred at 3.4% versus 4.2%, respectively.

治療相關不良事件在 ivonescimab 組中僅略有增加。任何重大事件的發生率分別為 99.2% 和 98.5%。ivonescimab 組和 tislelizumab 組的嚴重治療相關不良事件發生率分別為 32.3% 和 30.2%。導致停止 Ivonescimab 合併化療或 tislelizumab 合併化療的治療相關不良事件發生率分別為 3.4% 和 4.2%。

Based on the dual targeting of ivonescimab against PD-1 and VEGF, we analyzed adverse events that were thought to be immune-related or possibly VEGF-related. For the ivonescimab-plus-chemotherapy arm, compared to the tislelizumab-plus-chemotherapy arm, grade 3-plus potentially immune-related events were 10.2% versus 9%. And potentially, VEGF-related events increased from 2.3% to 7.5%. These events will be characterized further in the next slide.

基於ivonescimab對PD-1和VEGF的雙重標靶性，我們分析了被認為與免疫相關或可能與VEGF相關的不良事件。對於 ivonescimab 合併化療組，與 tislelizumab 合併化療組相比，3 級以上潛在免疫相關事件的發生率分別為 10.2% 和 9%。且潛在的 VEGF 相關事件從 2.3% 增加到 7.5%。下一張投影片將進一步描述這些事件。

On the right, events are split out by the specific terms for adverse events. The most common events for ivonescimab treatment in combination with chemotherapy were common chemotherapy-related adverse events, including alopecia, anemia, and various laboratory abnormalities, including neutrophil, white blood cell, and platelet count decreases. As such, these rates were similar and manageable between the two arms.

在右側，事件會依照不良事件的具體術語進行劃分。ivonescimab 合併化療治療最常見的事件是常見的化療相關不良事件，包括脫髮、貧血和各種實驗室異常，包括嗜中性球、白血球和血小板數量減少。因此，這兩組之間的比率相似且易於控制。

Focusing further on immune- and VEGF-related events, we see that most events were low grade. with approximately 9% to 10% of immune-related adverse events reaching grade 3 or higher in either arm. Of interest, grade 3 or higher IRAEs, serious IRAEs, and IRAEs leading to discontinuation of ivonescimab or tislelizumab were all numerically lower in the ivonescimab.

進一步關注免疫和 VEGF 相關事件，我們發現大多數事件都是低度的。每組約有 9% 至 10% 的免疫相關不良事件達到 3 級或更高。有趣的是，在 ivonescimab 中，3 級或更高級別的 IRAE、嚴重 IRAE 以及導致停用 ivonescimab 或 tislelizumab 的 IRAE 在數值上均較低。

Among the possibly VEGF-related events, proteinuria was seen in 27.1%, hemorrhage in 21.4%, and hypertension in 10.2% of patients. The vast majority being generally low grade, with the rate of grade 3 hemorrhage under 2%. Venous and arterial thrombotic events were zero in the control arm compared to 1% for each in the ivonescimab.

在可能與 VEGF 相關的事件中，27.1% 的患者出現蛋白尿，21.4% 的患者出現出血，10.2% 的患者出現高血壓。絕大多數出血一般為低度出血，3 級出血發生率低於 2%。對照組的靜脈和動脈血栓事件為零，而 ivonescimab 組分別為 1%。

I want to pause here for a moment and speak to the validating and convincing safety profile seen yet again with ivonescimab in the results of this study now in combination with myelosuppressive platinum doublet chemotherapy in a population of patients with advanced squamous non-small cell lung cancer, that was a real-world experience that included patients with central, potentially cavitary tumors, encasing vessels in some cases, and a history of hemoptysis in a significant fraction.

我想在這裡暫停一下，談談本次研究結果中再次看到的ivonescimab 的有效性和令人信服的安全性，該研究聯合骨髓抑制鉑類雙藥化療治療晚期鱗狀非小細胞肺癌患者，這是一次真實世界的體驗，其中包括患有中心性、潛在空洞性腫瘤的患者，在某些情況下有包裹血管的患者，以及相當一部分有咯血病史的患者。

This clearly differentiates ivonescimab from what is feasible with a combination of routinely used PD-1- or PD-L1-directed immune checkpoint inhibitor plus VEGF monoclonal antibody therapies administered together.

這使得 ivonescimab 與常規使用的 PD-1 或​​ PD-L1 免疫檢查點抑制劑與 VEGF 單株抗體聯合療法明顯區分開來。

In summary, ivonescimab provided a significant and clinically meaningful progression-free survival benefit for advanced squamous non-small cell lung cancer as first-line treatment of patients in HARMONi-6, with a hazard ratio of 0.60 that was consistent across all key subgroups, including those with negative, low, or high tumor PD-L1 expression, and those with liver or brain metastases.

總之，ivonescimab 作為 HARMONi-6 中晚期鱗狀非小細胞肺癌患者的一線治療，提供了顯著且具有臨床意義的無進展生存期益處，風險比為 0.60，與所有關鍵亞組一致，包括腫瘤 PD-L1 表達陰性、低或高的患者，以及肝臟或腦轉移的患者。

Hazard ratios in patients with negative, low, and high tumor PD-L1 expression were 0.55, 0.63, and 0.71, respectively. Ivonescimab's strong performance across all levels of tumor PD-L1 expression is important, as ivonescimab appears to provide clinically meaningful improvements to patients regardless of the degree of PD-L1 expression.

腫瘤 PD-L1 表達陰性、低和高的患者的風險比分別為 0.55、0.63 和 0.71。Ivonescimab 在所有腫瘤 PD-L1 表現水準上的強勁表現非常重要，因為無論 PD-L1 表現程度如何，Ivonescimab 似乎都能為患者帶來具有臨床意義的改善。

Response rate and duration of response were also increased. Ivonescimab was well tolerated, with less than 2% grade 3 or higher bleeding events and low rates of adverse events leading to discontinuation or death, both comparable to the tislelizumab-plus-chemotherapy arm. The incidences of any grade, treatment-related adverse events were similar between the two arms.

反應率和反應持續時間也增加了。Ivonescimab 耐受性良好，3 級或以上出血事件發生率不到 2%，導致停藥或死亡的不良事件發生率較低，均與 tislelizumab 聯合化療組相當。兩組間任何等級的治療相關不良事件的發生率相似。

Prior to HARMONi-6, there were no known Phase III clinical trials in non-small cell lung cancer that have shown a statistically significant improvement compared to PD-1 or PD-L1 inhibitor therapy in combination with chemotherapy in a head-to-head setting.

在 HARMONi-6 之前，尚無已知的非小細胞肺癌 III 期臨床試驗表明，與 PD-1 或​​ PD-L1 抑製劑療法聯合化療相比，在頭對頭治療中具有統計學上的顯著改善。

Following the success of Akeso's HARMONi-2 study in China, where the PFS benefit was observed in a monotherapy setting for patients who had squamous or non-squamous tumors that were positive for PD-L1 expression, this is now the second time in which we see ivonescimab-based regimens becoming the first known investigational therapy to demonstrate a statistically significant benefit compared to standard-of-care PD-1 or -L1 inhibitor-based regimen.

繼康方生物的 HARMONi-2 研究在中國取得成功之後，我們第二次看到基於 ivonescimab 的方案成為第一個已知的、與基於 PD-1 或​​ -L1 抑製劑的標準治療方案相比具有統計學上顯著益處的試驗性療法，該研究在單一療法中觀察到了 PFS 益處。

This underscores the specific value that ivonescimab and the HARMONi-6 regimen could bring to patients in this setting. With the opportunity to include a differentiated mechanism of action for physicians and patients to choose, ivonescimab has the potential to become a new standard of care for advanced squamous non-small cell lung cancer.

這強調了 ivonescimab 和 HARMONi-6 方案可以為這種情況下的患者帶來的特定價值。由於可以為醫生和患者提供差異化的作用機制選擇，ivonescimab 有可能成為晚期鱗狀非小細胞肺癌的新治療標準。

And we look forward to HARMONi-3, a global Phase III study reading out in the coming months and years. Importantly, we want to thank the patients and their families, the clinical site personnel, and the Akeso team for carrying out the HARMONi-6 trial.

我們期待未來數月和數年內全球第三階段研究 HARMONi-3 的成果。重要的是，我們要感謝患者及其家人、臨床現場人員以及康方團隊進行 HARMONi-6 試驗。

And now I'd like to turn it over to Maky.

現在我想把發言權交給 Maky。

Thanks, Jack. I would like to echo Jack's comments around our gratitude for the patients who enrolled on HARMONi-6, family members, trial site personnel, investigators, and of course, the Akeso team. We are slightly encouraged by the readout of this study to our other ongoing Phase III study in frontline non-small cell lung cancer, HARMONi-3, HARMONi-7, PD-1 therapy, with or without chemotherapy, depending on the PD-L1 status is the overwhelming standard of care in frontline driver mutation-negative lung cancer.

謝謝，傑克。我想同意傑克的評論，我們對參加 HARMONi-6 的患者、家人、試驗現場人員、研究人員，當然還有康方團隊表示感謝。我們對這項研究的結果感到有些鼓舞，這與我們正在進行的另一項針對一線非小細胞肺癌的 III 期研究 HARMONi-3、HARMONi-7、PD-1 療法（無論是否聯合化療）的結果相符，這取決於 PD-L1 狀態，這是一線驅動突變陰性肺癌的壓倒性治療標準。

Ivonescimab, both as monotherapy and in combination with chemotherapy, compares favorably to the result of the PD-1 monoclonal antibody previous studies. While additional overall survival data will be important to see in the future, a consistent, clinically meaningful, statistically significant resource in progression-free survival in HARMONi-6 and progression-free survival and interim overall survival data for HARMONi-2 announced previously are very encouraging when we look to global studies, HARMONi-3 and HARMONi-7 and beyond.

Ivonescimab 無論是作為單一療法還是與化療聯合使用，都與 PD-1 單株抗體先前研究的結果相比具有優勢。雖然未來需要更多的整體生存數據，但當我們回顧全球研究、HARMONi-3、HARMONi-7 及以後的研究時，HARMONi-6 中一致、具有臨床意義、具有統計學意義的無進展生存期資源以及之前公佈的 HARMONi-2 中無進展期生存期和中期總體生存期數據是非常令人鼓舞的。

Yesterday's HARMONi-6 results presented at ESMO and subsequently published in The Lancet are highly encouraging in showing the consistent performance of ivonescimab and its ability to break into a setting where existing anti-VEGF therapy is not an option due to historically observed tolerability concerns from early-phase clinical trials.

昨天在 ESMO 上公佈並隨後在《柳葉刀》上發表的 HARMONi-6 結果非常令人鼓舞，它展示了 ivonescimab 的穩定表現及其進入現有抗 VEGF 療法因早期臨床試驗中觀察到的耐受性問題而無法使用的領域的能力。

HARMONi-6 continues to validate the opportunity presented by ivonescimab to make a significant difference across a vast number of patients facing solid tumor diagnosis. I would also like to highlight several important updates to our Phase III clinical development program that we have announced over the past few days.

HARMONi-6 繼續驗證 ivonescimab 所提供的機會，為大量面臨實體瘤診斷的患者帶來顯著的改變。我還想強調我們過去幾天宣布的有關第三階段臨床開發計劃的幾個重要更新。

As we announced Friday, our clinical development plan has expanded beyond lung with the addition of our global Phase III HARMONi-GI3 trial, a brand-new study evaluating ivonescimab as first-line therapy in first-line unresectable colorectal cancer, including studies sponsored by our partner, Akeso.

正如我們週五宣布的那樣，我們的臨床開發計劃已擴展到肺癌之外，增加了全球 III 期 HARMONi-GI3 試驗，這是一項全新的研究，評估 ivonescimab 作為一線不可切除結直腸癌的一線治療，其中包括由我們的合作夥伴 Akeso 贊助的研究。

This brings a number of planned or ongoing Phase III clinical trials to 14 in total, evaluating ivonescimab in multiple solid tumors, including lung, colorectal, breast, head and neck, biliary tract, and pancreatic cancer. This is the fourth global Phase III study and the first global Phase III study to be conducted with ivonescimab beyond lung cancer.

這使得計劃中或正在進行的 III 期臨床試驗總數達到 14 項，評估 ivonescimab 在多種實體瘤中的療效，包括肺癌、結直腸癌、乳腺癌、頭頸癌、膽道癌和胰腺癌。這是第四項全球 III 期研究，也是第一項針對肺癌以外疾病進行的 ivonescimab 全球 III 期研究。

I will review the HARMONi-GI3 study design and what drove our conviction to initiate this study shortly. But I wanted to take a moment to remind everyone of the impressive development efforts behind the growing collective pipeline of ivonescimab.

我將回顧 HARMONi-GI3 研究設計以及促使我們啟動這項研究的動力。但我想花點時間提醒大家，ivonescimab 不斷增長的集體管道背後有著令人印象深刻的開發努力。

Turning to our ongoing Phase III trials, I will provide a regulatory update on HARMONi and as well as updates relating to a HARMONi-3 protocol amendment, including expectations for data readouts. I would like to take a moment to express our gratitude in working thus far with the FDA regarding our clinical development of ivonescimab.

談到我們正在進行的第三階段試驗，我將提供有關 HARMONi 的監管更新以及與 HARMONi-3 協議修訂相關的更新，包括對數據讀數的預期。我想花點時間表達我們對迄今為止與 FDA 就 ivonescimab 臨床開發進行的合作的感激之情。

With four Phase III clinical studies, we have had a number of interactions with the agency. And their feedback and advice are invaluable. When we plan to move forward with the HARMONi study upon signing the collaboration agreement to acquire the rights to ivonescimab, we have multiple interactions with an agency regarding how to proceed.

透過四項 III 期臨床研究，我們與該機構進行了多次互動。他們的回饋和建議非常寶貴。當我們簽署合作協議以獲取 ivonescimab 的權利併計劃推進 HARMONi 研究時，我們與一家機構就如何進行進行了多次互動。

The collaboration demonstrated our ability to move forward with a clinical study based on early-phase clinical trial data that have been generated in China prior to our acquisition of our rights, given the strong potential of ivonescimab and opportunity to make a meaningful difference to patients in a setting that has very limited therapy options in something that really reflects the agency's commitment to patients facing difficult diagnosis with limited options.

此次合作表明，我們有能力根據在我們獲得權利之前在中國生成的早期臨床試驗數據推進臨床研究，因為 ivonescimab 具有強大的潛力，並且有機會在治療選擇非常有限的環境中為患者帶來有意義的改變，這真正反映了該機構對面臨診斷困難且選擇有限的患者的承諾。

We are incredibly proud to work with the agency and appreciate endless hours that members of the agency spend, with the best interest of patients always in mind. Based on the result of the HARMONi study, today, we announced that we will submit a biologics license application or BLA with the FDA in order to seek approval for ivonescimab plus chemotherapy for this proposed indication in the United States. We intend to submit the BLA during the fourth quarter of 2025.

我們非常自豪能夠與該機構合作，並感謝該機構成員投入的無數時間，始終將患者的最大利益放在心上。根據 HARMONi 研究的結果，今天，我們宣布將向 FDA 提交生物製品許可申請或 BLA，以尋求在美國批准 ivonescimab 聯合化療用於治療該擬議適應症。我們打算在 2025 年第四季提交 BLA。

As previously disclosed, the FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization in this setting. After a careful consideration of the safety and efficacy profile of the current FDA-approved options to patients in this setting, the positive regional consistent results of this Phase III multi-regional study as well as discussions with key opinion leaders and physicians who have administered ivonescimab to patients, we believe that the safety and efficacy data generated in the HARMONi study demonstrate that patients suffering for EGFR-mutant, non-small cell lung cancer in this setting can benefit from the ivonescimab regimen.

如前所述，FDA 指出，需要具有統計意義的整體存活獲益才能支持此情況下的行銷授權。在仔細考慮了目前 FDA 批准的針對此類患者的治療方案的安全性和有效性、該 III 期多區域研究的積極區域一致性結果以及與關鍵意見領袖和已為患者施用過 ivonescimab 的醫生的討論後，我們認為 HARMONi 研究中產生的安全性和有效性數據表明，患有此類 EGFR 突變型非小細胞肺癌的患者可以從 ivonesconebimab。

This is a monumental moment in the development of ivonescimab, and we are excited for the opportunity to work with the US FDA in order to discuss our application. Yesterday, we also announced updates to our global Phase III HARMONi-3 study, which is intended to evaluate ivonescimab combined with chemotherapy compared to Pembro, an anti-PD-1 antibody, combined with chemotherapy in patients with first-line metastatic squamous and non-squamous non-small cell lung cancer.

這是 ivonescimab 開發過程中的一個重要時刻，我們很高興有機會與美國 FDA 合作討論我們的申請。昨天，我們也宣布了全球 III 期 HARMONi-3 研究的最新進展，該研究旨在評估 ivonescimab 聯合化療與抗 PD-1 抗體 Pembro 聯合化療治療一線轉移性鱗狀和非鱗狀非小細胞肺癌患者的療效。

This study is currently enrolling patients globally and is conducted with registrational intent for the United States and other regions within Summit licensed territories. The primary endpoints for this study are progression-free survival and overall survival.

這項研究目前正在全球招募患者，並在美國和 Summit 許可區域內的其他地區註冊。本研究的主要終點是無惡化存活期和總存活期。

Summit has amended the protocol for the HARMONi-3 study in order to separate the statistical analysis of data of the primary endpoint by histology. Therefore, -- there will be separate analysis conducted to evaluate ivonescimab plus chemotherapy compared to pembro plus chemo in patients with squamous non-small cell lung cancer and in patients with non-squamous non-small cell lung cancer.

Summit 修改了 HARMONi-3 研究的方案，以便根據組織學分離主要終點資料的統計分析。因此，將進行單獨的分析來評估 ivonescimab 聯合化療與 pembro 聯合化療在鱗狀非小細胞肺癌患者和非鱗狀非小細胞肺癌患者中的療效。

As a result of having two separate intention to treat analysis within the HARMONi-3 study, the analysis for squamous tumors and non-squamous tumors may be conducted at separate time, as each analysis will be conducted upon reaching pre-specified numbers of events in each cohort.

由於 HARMONi-3 研究中存在兩個單獨的意向治療分析，因此鱗狀腫瘤和非鱗狀腫瘤的分析可能會在不同的時間進行，因為每項分析都將在每個隊列達到預先指定的事件數量後進行。

Ultimately, it will allow us to read our data earlier for squamous non-small lung cancer and ultimately potentially move forward more quickly in frontline lung cancer for patients seeking improved options over the existing standards of care.

最終，它將使我們能夠更早讀取鱗狀非小細胞肺癌的數據，並最終有可能為尋求優於現有護理標準的治療方案的患者在一線肺癌治療中更快地取得進展。

Currently, we expect to complete enrollment in the squamous cohort of HARMONi-3 in the first half of 2026 and expect to reach the prespecified number of events for the progression-free survival, dual primary endpoint analysis for the squamous cohort in the second-half of 2026. An interim analysis for overall survival may be conducted at a similar time.

目前，我們預計將於 2026 年上半年完成 HARMONi-3 鱗狀細胞隊列的招募，並預計將於 2026 年下半年達到鱗狀細胞隊列無進展生存期、雙主要終點分析的預定事件數。可以在相似的時間進行總體存活期的中期分析。

Turning to non-squamous, at present time, Summit expects to complete enrollment in the non-squamous cohort of HARMONi-3 in the second half of 2026 and expect to reach the prespecified number of events for the progression-free survival endpoint analysis for this non-squamous cohort in the first half of 2027. An interim analysis for overall survival is planned to be conducted based upon reaching a prespecified number of events.

談到非鱗狀細胞癌，目前，Summit 預計將在 2026 年下半年完成 HARMONi-3 非鱗狀細胞癌隊列的招募，並預計在 2027 年上半年達到該非鱗狀細胞癌隊列無進展生存終點分析的預定事件。計劃在達到預定事件數量的基礎上進行總體生存期的中期分析。

In order to sufficiently power each of the dual primary endpoints in both cohorts of the study, Summit plans to enroll approximately 600 patients with squamous non-small cell lung cancer and approximately 1,000 patients with non-squamous non-small cell lung cancer for a total of approximately 1,600 patients enrolled in HARMONi-3, which is reflected in this updated HARMONi-3 study design slide.

為了充分支持研究中兩個隊列中的每個雙重主要終點，Summit 計劃招募約 600 名鱗狀非小細胞肺癌患者和約 1,000 名非鱗狀非小細胞肺癌患者，總共約 1,600 名患者參加 HARMONi-3，這反映在更新的 HARMONi-3 研究設計幻燈片中。

While we are increasing the sample size, we are over 80% enrolled in the squamous cohort. And as I mentioned, we believe we will complete enrollment in the first half of next year. And the non-squamous cohort is enrolling fast and will complete enrollment short time, thereafter, currently projected to be the second half of next year.

雖然我們正在增加樣本量，但鱗狀細胞癌隊列的樣本量已超過 80%。正如我所提到的，我們相信我們將在明年上半年完成招生。非鱗狀細胞癌隊列的招募速度很快，很快就會完成招募，目前預計在明年下半年完成。

This ultimately will allow us to have this technologies fully powered by cohort in order to allow for us to have a clear regulatory path forward for frontline lung cancer around the world. As mentioned earlier, our Phase III clinical development program has expanded beyond the lung, with the intention of HARMONi-GI3, a global Phase III trial evaluating ivonescimab plus chemo compared to VEGF plus chemo as first-line therapy in patients with unresectable metastatic colorectal cancer.

這最終將使我們能夠完全由隊列驅動該技術，以便我們能夠為世界各地的一線肺癌提供明確的監管路徑。如前所述，我們的 III 期臨床開發計畫已擴展到肺部以外的領域，旨在進行 HARMONi-GI3，這是一項全球 III 期試驗，旨在評估 ivonescimab 聯合化療與 VEGF 聯合化療作為不可切除轉移性結直腸癌患者的一線治療效果。

Here, we see the study for HARMONi-GI3, which has a primary endpoint of progression-free survival. Clinical trial sites in the United States are planned to begin activating by the end of this year. And we currently expect to enroll a total of 600 patients in HARMONi-GI3.

在這裡，我們看到了 HARMONi-GI3 的研究，其主要終點是無惡化存活期。美國臨床試驗點計劃於今年底開始啟動。目前我們預計在 HARMONi-GI3 中招募總共 600 名患者。

Each year, 48,000 patients are estimated to be diagnosed with or have recurrent or metastatic microsatellite stable metastatic colorectal cancer, also known as mismatch-repair proficient colorectal cancer or pMMR/CRC. There have been limited options approved in the United States in the last 20 years for those first-line patients whose tumors are not positive for certain biomarkers or other activating mutations.

據估計，每年有 48,000 名患者被診斷出患有復發性或轉移性微衛星穩定性轉移性結直腸癌，也稱為錯配修復功能正常的結直腸癌或 pMMR/CRC。在過去 20 年裡，美國批准的針對腫瘤對某些生物標記或其他活化突變不呈陽性的第一線患者的治療選擇有限。

Microsatellite stable metastatic colorectal cancer is a setting where monoclonal PD-1 inhibitors, such as pembro and nivo, have failed to show a clinically meaningful benefit. Anti-VEGF therapy like ivonescimab plus chemotherapy is the standard of care for many patients with first-line metastatic -- microsatellite stable metastatic colorectal cancer.

微衛星穩定轉移性大腸直腸癌是一種單株 PD-1 抑制劑（如 pembro 和 nivo）未能顯示出具有臨床意義的益處的情況。抗 VEGF 療法（如 ivonescimab）加上化療是許多第一線轉移性－微衛星穩定型轉移性大腸直腸癌患者的標準治療方法。

Based on extensive feedback with KOLs and treating physicians in this space, we have opted to evaluate ivonescimab with FOLFOX in this study. I will take a moment to walk through the data we have previously shared in first-line CRC as a brief reminder as to the potential of ivonescimab in this setting.

根據該領域 KOL 和治療醫生的廣泛回饋，我們選擇在本研究中將 ivonescimab 與 FOLFOX 進行評估。我將花一點時間來回顧我們之前在一線 CRC 中分享的數據，以簡要提醒 ivonescimab 在這種情況下的潛力。

While the data is with FOLFOXIRI, a more intense chemotherapy regimen, we also noted in our release that we enrolled patients in both the US and China with FOLFOX as well to test ivonescimab with multiple chemotherapy options. FOLFOX in combination with a monoclonal antibody, such as VEGF, represent a preferred treatment regimen for physicians treating MSS CRC patients in the United States and other Western territories.

雖然數據來自強度更高的化療方案 FOLFOXIRI，但我們在發布中也指出，我們在美國和中國都招募了接受 FOLFOX 治療的患者，以測試 ivonescimab 與多種化療方案的療效。FOLFOX 與單株抗體（如 VEGF）的合併使用是美國和其他西方地區醫師治療 MSS CRC 患者的首選治療方案。

Last year, at the 2024 Annual Congress of the European Society of Medical Oncology or ESMO 2024, Akeso presented encouraging AK112-206 Phase II data of ivonescimab in combination with FOLFOXIRI chemotherapy in patients with microsatellite stable metastatic colorectal cancer. Here, we see the figure for Akeso AK112-206 study.

去年，在2024年歐洲腫瘤內科學會（ESMO 2024）年會上，康方生物發表了ivonescimab聯合FOLFOXIRI化療治療微衛星穩定性轉移性結直腸癌患者的令人鼓舞的AK112-206 II期數據。這裡我們看到了康方 AK112-206 研究的圖表。

In this Phase II study, ivonescimab, in combination with chemotherapy, demonstrated an overall response rate of 81.8% and a DCR of 100% in 22 patients. This cohort of AK112-206 was conducted in China sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

在這項 II 期研究中，ivonescimab 聯合化療在 22 名患者中顯示出 81.8% 的總體反應率和 100% 的 DCR。AK112-206 隊列研究在中國由康方生物贊助開展，所有相關數據均由康方生物獨家生成、管理和分析。

In the ivonescimab-plus-FOLFOXIRI-chemotherapy arm, there were no treatment-emergent adverse events that led to permanent discontinuation of ivonescimab as of the data cutoff from the ESMO 2024 presentation. Subsequently, as I said, this Phase II study was expanded to include additional patients from the US and China to study ivonescimab in combination with FOLFOX chemotherapy.

在 ivonescimab 合併 FOLFOXIRI 化療組中，截至 ESMO 2024 年報告的數據截止，沒有出現導致永久停用 ivonescimab 的治療出現的不良事件。隨後，正如我所說，這項 II 期研究擴大到包括來自美國和中國的更多患者，以研究 ivonescimab 與 FOLFOX 化療的聯合治療。

The data from the initial patient cohort presented at ESMO 2024 have continue to mature in addition to the global Phase II data generated in combination with FOLFOX in the United States and China, which supports the design of Summit Phase III HARMONi-GI3 study.

除了在美國和中國與 FOLFOX 聯合產生的全球 II 期數據外，ESMO 2024 上展示的初始患者隊列數據也在不斷成熟，這支持了 Summit III 期 HARMONi-GI3 研究的設計。

In addition to the announcement of HARMONi-GI3, a new global Phase III study in first-line unresectable metastatic colorectal cancer, Summit today announces its intention to expand its ivonescimab clinical development program with an additional set of Phase III clinical studies. We intend to provide additional color with respect to these Phase III studies in the first quarter of 2026.

除了宣布針對一線不可切除轉移性結直腸癌的全球新 III 期研究 HARMONi-GI3 之外，Summit 今天還宣布打算透過另外一組 III 期臨床研究來擴展其 ivonescimab 臨床開發計劃。我們打算在 2026 年第一季提供有關這些 III 期研究的更多詳細資訊。

With that, I will now turn the call over to Manmeet to provide an operational and financial update for the quarter. Manmeet?

說完這些，我現在將電話轉給 Manmeet，讓他提供本季的營運和財務更新。男人見面？

Thank you, Maky, and good morning, everyone. Today, in addition to providing the year update on our cash position and operating expenses, I will also provide color on our clinical operations. Let me start with an update on the clinical operations product.

謝謝你，Maky，大家早安。今天，除了提供我們現金狀況和營運費用的年度更新外，我還將介紹我們的臨床營運情況。首先讓我介紹一下臨床操作產品的最新情況。

The HARMONi-3 study is enrolling ahead of our goals. And as Maky mentioned, we have enrolled over 80% of the newly planned 600 squamous patients cohort and now expect to complete enrollment for the squamous cohort of HARMONi-3 during the first quarter of 2026.

HARMONi-3 研究的招募工作已經提前完成了我們的目標。正如 Maky 所提到的，我們已經招募了新計劃的 600 名鱗狀患者隊列的 80% 以上，現在預計將在 2026 年第一季完成 HARMONi-3 鱗狀隊列的招募。

To remind you, the non-squamous cohort in HARMONi-3 was initiated during first quarter of 2025, and that, too, is enrolling ahead of the plan. And now we expect to complete enrollment for 1,000 patients during the second half of 2026.

提醒您，HARMONi-3 中的非鱗狀細胞隊列是在 2025 年第一季啟動的，而且也是提前於計劃招募的。現在我們預計將在 2026 年下半年完成 1,000 名患者的招募。

Our HARMONi-7 study was initiated during the first quarter of 2025, and we have activated over 50% of the selected sites globally. And for our newly announced Phase III, the HARMONi-GI3 study, we have already started planning. And sites are planned to begin activating in the United States prior to the end of the year 2025.

我們的 HARMONi-7 研究於 2025 年第一季啟動，我們已啟動全球超過 50% 的選定站點。對於我們新宣布的第三階段 HARMONi-GI3 研究，我們已經開始規劃。這些站點計劃於 2025 年底前在美國開始啟用。

On the financial front, let me start with our cash position. We ended the third quarter of 2025 with a cash position of approximately $238.56 million. Turning to operating expenses, I'll provide details on both GAAP and non-GAAP numbers. You can refer to our press release issued this morning for a reconciliation of GAAP to non-GAAP financial measures. As a reminder, our non-GAAP expenses exclude stock-based compensation expenses.

在財務方面，讓我先從我們的現金狀況開始。截至 2025 年第三季度，我們的現金狀況約為 2.3856 億美元。談到營運費用，我將提供 GAAP 和非 GAAP 數字的詳細資訊。您可以參考我們今天早上發布的新聞稿，以了解 GAAP 與非 GAAP 財務指標的對帳。提醒一下，我們的非公認會計準則費用不包括股票薪資費用。

Our total GAAP operating expenses for the third quarter of 2025 was $234.2 million, compared to $568.4 million for the second quarter of 2025. The decrease in GAAP operating expenses was primarily due to the higher stock-based compensation expense of approximately $348.2 million as a result of the modification of unvested stock options recorded during the previous quarter.

我們 2025 年第三季的 GAAP 總營運費用為 2.342 億美元，而 2025 年第二季為 5.684 億美元。GAAP 營業費用的減少主要是由於上一季記錄的未歸屬股票選擇權修改導致股票薪酬費用增加約 3.482 億美元。

Overall, our non-GAAP operating expenses during the third quarter of 2025 were $103.4 million, compared to $89.6 million for the previous quarter. The increase in non-GAAP operating expenses was primarily related to an increase in R&D expenses related to HARMONi-3 and HARMONi-7 trials.

整體而言，我們 2025 年第三季的非 GAAP 營運費用為 1.034 億美元，而上一季為 8,960 萬美元。非公認會計準則營業費用的增加主要與 HARMONi-3 和 HARMONi-7 試驗相關的研發費用增加有關。

And with that, I will hand it back over to Dave. Dave?

說完這些，我就把它交還給戴夫。戴夫？

Thank you, team. We'll now see if there are any questions that our team can help answer. Kate, if you could please open the line for questions?

謝謝你們，團隊。我們現在看看是否有任何問題需要我們的團隊幫助解答。凱特，您能打開熱線來回答問題嗎？

(Operator Instructions) Yigal Nochomovitz, Citi.

（操作員指示）Yigal Nochomovitz，花旗。

Hi, great. Thank you very much for taking the questions. So the first one I had is, when could we expect to see the first OS cut from HARMONi-6? Would it be before the second-half 2026 PFS readout for HARMONi-3 and squamous?

嗨，太好了。非常感謝您回答這些問題。所以我的第一個問題是，我們什麼時候可以看到 HARMONi-6 中的第一個作業系統？這會是在 2026 年下半年 HARMONi-3 和鱗狀細胞癌的 PFS 讀數之前嗎？

And then the other question is, given HARMONi-6 was powered 86.3% for a hazard ratio of 0.7 but you hit on a lower hazard ratio of 0.6, I'm curious what that may imply about OS powering for the study given that was powered at 80% for a hazard ratio of 0.73, the implication potentially that you may have more OS power than originally designed? Thanks.

然後另一個問題是，假設 HARMONi-6 的功效為 86.3%，風險比為 0.7，但您得到的風險比較低，為 0.6，我很好奇這對該研究的 OS 功效意味著什麼，因為該研究的功效為 80%，風險比為 0.73，這可能意味著您的 OS 功效可能比最初設計的 OS 功效強？謝謝。

Very good question. Dave?

非常好的問題。戴夫？

Thanks, Yigal. This is Dave. So one thing that I want to make sure is clear, as we mentioned, this is a study that was designed and conducted by our partners at Akeso. And so one thing that we don't do is get in front of Akeso with respect to disclosing additional details beyond what they have currently disclosed.

謝謝，伊加爾。這是戴夫。因此，我想確保清楚的一件事是，正如我們所提到的，這是一項由康方生物的合作夥伴設計和進行的研究。因此，我們不會做的一件事就是事先告知康方生物，並揭露超出其目前揭露範圍的額外細節。

And so I think if we look overall, the -- obviously, just the protocol is included within publication. And I want to congratulate again our partners at Akeso for both the presentation and The Lancet publication that became available yesterday.

因此，我認為如果我們從整體上看，顯然，只有協議包含在出版物中。我要再次祝賀康方生物的合作夥伴，祝賀他們昨天所做的演講和在《柳葉刀》雜誌上發表的出版物。

But in terms of differentiating details between the plans and adjusted power and whatnot, I leave that to our partners at Akeso. But I think one thing that you can see from, in general, the plan for testing is that there's likely something that can be reviewed in 2026.

但至於計畫之間的細節區分、功率調整等等，我將交給康方生物的合作夥伴。但我認為，從總體測試計劃中可以看出，很可能在 2026 年可以審查一些內容。

But it's important to remember that from a time-to-event perspective and a prespecified number of events in an analysis, we hope patients do well. And we hope patients continue to exceed expectations and to knowing exactly the order of events becomes a little bit difficult, excuse me.

但重要的是要記住，從事件發生的時間角度和分析中預先指定的事件數量來看，我們希望患者表現良好。我們希望患者繼續超出預期，但要準確了解事件的順序會有點困難，請原諒我。

But this is events-driven. So at some point, next year is probably a fair estimate. But more specific to that is a little bit beyond where we would like to disclose at this point and defer to our partners there.

但這是由事件驅動的。因此從某種程度上來說，明年可能是一個合理的估計。但更具體地說，這有點超出了我們目前願意披露的範圍，並推遲給我們的合作夥伴。

And then just the other follow-up. Obviously, Maky, you talked a lot about new studies, CRC, and then you mentioned additional set of Phase IIIs where you might get more details in 1Q '26. So all of that points to questions around funding.

然後是其他後續行動。顯然，Maky，您談了很多關於新研究、CRC 的內容，然後您提到了額外的 III 期研究，您可能會在 2026 年第一季獲得更多細節。所以所有這些都指向有關資金的問題。

I'm just curious if you could speak at least to some extent as to what options are being evaluated to extend the runway, what the priorities are in terms of how you may raise additional capital. Thank you.

我只是好奇，您是否可以至少在某種程度上談談正在評估哪些選項來延長跑道，以及在如何籌集額外資金方面優先考慮的事項是什麼。謝謝。

Hi, Yigal. Maky prefers that I answer the (inaudible) question.

你好，伊加爾。Maky 希望我回答這個（聽不清楚）問題。

(multiple speakers) Okay. Well, go ahead.

（多位發言者）好的。好吧，繼續吧。

Now that she doesn't have a (technical difficulty). Yeah, we have an ATM out there with, give or take, $350 million. I've already had some inbound interest, additional capital. I'm interested. I've invested a few weeks ago, additional capital. So yeah, we'll move straightforward on that. And I'm happy to have the opportunity, and I think others are, too. So you'll see that as it plays out.

現在她沒有（技術難度）。是的，我們有一台 ATM，裡面有大約 3.5 億美元的現金。我已經有一些入站興趣和額外資本。我有興趣。幾週前我投資了額外的資金。是的，我們會直接處理這個問題。我很高興能有這樣的機會，我想其他人也一樣。因此，當事情發展到一定程度時，您就會看到這一點。

I won't predict the amount right yet. But I'm aware of all the numbers, and I'm aware of the plans going forward. We have empirical evidence that this is a product that is crying out for significant investment to demonstrate its capacity to enter into a business that the leading player is generating roughly $34 million in revenue over the next three years, $17 million, $18 million -- $3 billion in free cash flow.

我現在還無法正確預測數量。但我知道所有的數字，也知道未來的計畫。我們有經驗證據表明，這是一種迫切需要大量投資的產品，以證明其進入該行業的能力，領先企業將在未來三年內創造約 3,400 萬美元的收入，1,700 萬美元、1,800 萬美元——30 億美元的自由現金流。

So this is a significant opportunity, and we do not want to miss it. We have -- we also feel that the key to making that happen is for this team to have control to be able to start, stop, and change a number of variables leading to our ultimate success, and we're happy with the position that we have. So I hope that gives you some addressment to the issues of finance.

所以這是一個重要的機會，我們不想錯過。我們也認為，實現這一目標的關鍵在於讓這個團隊擁有控制權，能夠啟動、停止和改變一系列變量，從而最終取得成功，我們對目前的狀況感到滿意。我希望這能為你們提供一些有關財務問題的解答。

And as soon as we have more information regarding other clinical trials, for sure, we are going to communicate as time allows.

一旦我們獲得有關其他臨床試驗的更多信息，我們肯定會在時間允許的情況下進行溝通。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Congratulations on the unprecedented HARMONi-6 results. I guess, I want to ask about the BLA submission. Given the confirmation of the ivonescimab BLA by year-end based upon the HARMONi data, can you provide any color as to how your interactions with the FDA have gone? And how the present approvals with ivonescimab or data might support approval of ivonescimab?

祝賀 HARMONi-6 取得前所未有的成果。我想問一下有關 BLA 提交的問題。鑑於根據 HARMONi 數據，ivonescimab BLA 將在年底前得到確認，您能否提供一些關於您與 FDA 互動情況的資訊？目前對 ivonescimab 的批准或數據如何支持對 ivonescimab 的批准？

Thanks for the question. -- This is Urte. Yes, we announced today and also the press release that we are planning to file in the fourth quarter of this year. As we finalize including the package together, we had continuous interaction with the FDA. And obviously, after we have made this position, we are looking forward to getting specific feedback and giving some color earlier next year after the submission.

感謝您的提問。 ——我是 Urte。是的，我們今天宣布了這一消息，同時我們也發布了我們計劃在今年第四季提交的新聞稿。當我們最終將包裝整合在一起時，我們與 FDA 進行了持續的互動。顯然，在我們做出這一立場之後，我們期待在明年年初提交意見後得到具體的反饋並給出一些說明。

We have indeed reviewed the most recent, of course, (technical difficulty) -- approval, and it’s accurate, as you mentioned. The relevance is the approval for ivonescimab, the previously treated EGFR patients as well as the JSC-X approval in also previously treated EGFR patients.

當然，我們確實審查了最新的（技術難題）批准，而且正如您所說，它是準確的。相關性在於 ivonescimab 對先前接受過治療的 EGFR 患者的批准以及 JSC-X 對先前接受過治療的 EGFR 患者的批准。

As you are aware, and obviously, we are fully aware that neither of those other approvals included a significant OS benefit. We have also disclosed previously, but I’m just repeating it, that FDA has told us that they’re looking for expecting OS in our setting. We do think that the totality of our data from a combination of efficacy and safety is a strong package. And it should be moved forward to becoming available for these patients. So, therefore, we are moving forward with the submission as we have announced.

如您所知，而且顯然我們也完全清楚，這些其他批准均未帶來顯著的作業系統優勢。我們之前也曾披露過，但我只是重複一遍，FDA 告訴我們，他們正在我們的環境中尋找預期 OS。我們確實認為，從功效和安全性角度來看，我們的全部數據都是強而有力的。並且應該進一步推動該療法的普及，讓這些患者也能享受。因此，我們將按照我們宣布的程序來推進提交工作。

That's great. And just as a quick follow-up, did you discuss the latest overall survival data that surpassed the statistical threshold at World Lung with the FDA?

那太棒了。作為一個快速的後續問題，您是否與 FDA 討論過超過世界肺臟統計閾值的最新總體生存數據？

Yes, we are not going to go into the details of exact discussions with the FDA, but I can confirm that we have a close contact with them and be sharing information whenever appropriate with them.

是的，我們不會詳細討論與 FDA 的具體討論，但我可以確認我們與他們保持密切聯繫，並在適當的時候與他們分享資訊。

Brad Canino, Guggenheim Securities.

古根漢證券公司的布拉德卡尼諾。

Hey, thanks, team Summit. Again, great to see the data at ESMO in front of a large crowd yesterday. Maybe another follow-up on the BLA. I understand the logic of trying to get this drug to patients as quick as possible, given the data that you have. From a business perspective, can you help me understand the strategic thinking of now wanting to submit the HARMONi study and undertaking that review issue of how to deal with the OS as the first time the FDA will review a BLA package for ivonescimab, especially when you have HARMONi -3 potentially coming as soon as second-half 2026 for PFS and OS?

嘿，謝謝 Summit 團隊。再次，很高興昨天在 ESMO 上向眾多觀眾展示數據。也許是對 BLA 的另一個後續行動。根據您掌握的數據，我理解盡快將這種藥物送達患者的邏輯。從商業角度來看，您能否幫助我理解現在想要提交 HARMONi 研究並承擔如何處理 OS 的審查問題的戰略思想，因為這是 FDA 首次審查 ivonescimab 的 BLA 方案，尤其是當您的 HARMONi -3 可能最早在 2026 年下半年推出 PFS 和 OS 時？

I guess my thinking was that might be a better package to submit first and then have HARMONi come as a supplement or something like that. Just how you’re thinking about that would be helpful to hear. Thank you.

我的想法是，最好先提交一個方案，然後讓 HARMONi 作為補充或類似的東西。聽聽您對此有何看法將會很有幫助。謝謝。

Sure. So we have had certainly many discussions, just to confirm internally, and there are many of these scenarios. But -- in principle, our thinking is that each indication will have its own submission. This particular package is ready now. We have virtual data. We have shown consistency in the data with our long-term follow-up between the Western patients and the Asian patients.

當然。因此，我們確實進行了很多討論，只是為了在內部確認，並且存在著許多這樣的情況。但是——原則上，我們的想法是每個跡像都會有自己的提交。這個特殊的包裹現在已經準備好了。我們有虛擬資料。我們對西方患者和亞洲患者進行長期跟踪，結果顯示數據一致。

And we think this is the right opportunity, and we are going forward with this. That doesn’t mean in the future we are continually going to look at this, and we might do other packages in the future. Depending on exactly what comments and feedback we ultimately also get from the FDA, we will make those adjustments and support it in the future.

我們認為這是正確的機會，我們將繼續推進這一進程。這並不意味著我們將來會繼續關注這個問題，我們未來可能會做其他的方案。根據我們最終從 FDA 獲得的具體評論和回饋，我們將做出調整併在未來提供支持。

Got it. Thank you. And then separately, just quickly on the colorectal Phase III, you mentioned there’s some undisclosed in-house data. Can you talk qualitatively about what that is, the extent of it, and what these were explored? When might we expect to see those data presented to further support the Phase III? Thank you.

知道了。謝謝。然後，另外，關於大腸直腸癌 III 期研究，您提到有一些未公開的內部數據。您能否定性地談談它是什麼、它的程度以及探索了什麼？我們什麼時候可以看到這些數據來進一步支持第三階段？謝謝。

Sure, Brad. This is Dave. I think one of the things that Maky spoke about was we had previously presented data with our partners at Akeso Inc. in 2024 at ESMO and that was validating with respect to not just colorectal, but head and neck, as well as triple-negative breast cancer.

當然，布拉德。這是戴夫。我認為 Maky 談到的一件事是，我們之前曾在 2024 年的 ESMO 上與 Akeso Inc. 的合作夥伴一起展示過數據，這些數據不僅針對結直腸癌，還針對頭頸癌以及三陰性乳腺癌進行了驗證。

What has since happened, both Akeso Inc. as well as an expansion of that Phase II to include patients in the US, was conducted. With that, we’ve had multiple backbones of chemotherapy, which have been reviewed with ivonescimab, as well as a novel-novel combination with ivonescimab in this setting. And so what that’s done is it’s given a bit of exposure to the drug, as well as the ability to compare historical results with different chemo backbones in order to kind of validate what we’re seeing and the consistency of that data.

此後，康方生物和其子公司康方生物均開展了 II 期臨床試驗，並將美國患者納入其中。有了它，我們已經有了多種化療主幹，這些化療主幹已經與 ivonescimab 一起進行了審查，並且在這種情況下與 ivonescimab 進行了新穎的組合。這樣做的目的是讓人們接觸到這種藥物，並能夠將歷史結果與不同的化療主幹進行比較，以驗證我們所看到的內容以及數據的一致性。

We ultimately chose based on the standard of care that exists and the strong preference for both patients and physicians to move forward with the FOLFOX regimen. There’s quite a bit of data that’s been generated across a number of different backbones, which gives us quite a bit of confidence.

我們最終根據現有的護理標準以及患者和醫生對繼續使用 FOLFOX 方案的強烈偏好做出了選擇。我們已經在許多不同的主幹網路上產生了相當多的數據，這給了我們相當大的信心。

And -- as I’m sure you’re aware, but also to note, our partners at Akeso Inc. are running a Phase III study in this setting as well. It’s just another data point with respect to confidence that we have in terms of ivonescimab’s opportunity in this setting.

而且—我相信您已經知道，但也需要注意的是，我們在康方生物的合作夥伴也正在這種環境中進行第三階段研究。這只是關於我們對 ivonescimab 在此環境中的機會的信心的另一個數據點。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Thank you for taking my questions. With regard to HARMONi-6, the PD-L1 by status was interesting, and we see PD-L1, sorry, negative outperform PD-L1 positive. Could you just help us maybe understand what’s playing out there, and then the translational work that you’re going to be doing to kind of help the oncologists with determining how to best position here?

感謝您回答我的問題。關於 HARMONi-6，PD-L1 的狀態很有趣，我們看到 PD-L1，抱歉，陰性優於 PD-L1 陽性。您能否幫助我們了解目前的情況，然後您將要進行的轉化工作如何幫助腫瘤學家確定最佳定位？

In terms of HARMONi-6 and the PD-L1 expression, I would say that it’s not, I don’t see it as necessarily that the negatives are outperforming the others, but rather that the differential effect is a little greater in the PD-L1 negative patients.

就 HARMONi-6 和 PD-L1 表現而言，我想說，並不是說陰性患者的表現一定優於其他患者，而是 PD-L1 陰性患者的差異效應較大。

To me, that’s not that surprising. I would say that as a clinician talking with all of my other clinician colleagues, we’ve long recognized that although other regimens that are FDA approved here have some incremental benefit from the addition of the checkpoint inhibitor, that benefit is tepid. It’s rather minimal.

對我來說，這並不奇怪。我想說，作為一名臨床醫生，我與所有其他臨床醫生同事交談時，我們早就認識到，儘管 FDA 批准的其他方案通過添加檢查點抑製劑可以獲得一些增量益處，但這種益處並不明顯。它相當小。

And these are patients, this whole group is one that has disappointing outcomes even with our current standard of care. So there’s really a lot of room to do better. In this case, I would say that it may be suggestive that this is a setting where VEGF components may be especially relevant.

這些都是患者，即使按照我們目前的照護標準，整個團體的治療結果都令人失望。因此，確實還有很大的進步空間。在這種情況下，我想說這可能表明 VEGF 成分可能特別相關。

And I will say that it’s important to also recognize these are subsets. We’re going to have additional information to look at these and whether it’s consistent trends between HARMONi-6 and HARMONi-3, but it’s important to note that in the patients, particularly with the high PD-L1, that group had a smaller, that was about half of the size of the other groups.

我想說的是，認識到這些是子集也很重要。我們將獲得更多資訊來研究這些以及 HARMONi-6 和 HARMONi-3 之間是否存在一致的趨勢，但值得注意的是，在患者中，特別是 PD-L1 較高的患者中，該組的規模較小，約為其他組的一半。

So I wouldn’t want to put too fine a point on any of these subset analyses. They’re just suggestive, and all of them showed the same trend or the same overall conclusion of being superior with ivonescimab, just to varying degrees.

所以我不想對這些子集分析進行過度的強調。它們只是具有啟發性，而且它們都顯示出相同的趨勢或相同的總體結論，即 ivonescimab 優於其他藥物，只是程度不同。

Brad, if I may just touch back on your question on EGFR, we were really pleased that the FDA approved our taking that trial on. There were a number of major issues to handle on that trial. One of them was China versus USA data translatability. That was a -- we put a real feather in the cap that there is some significant translatability. That is obviously a very dynamic issue.

布拉德，如果我可以再次回答你關於 EGFR 的問題，我們非常高興 FDA 批准我們進行試驗。該審判中有許多重大問題需要處理。其中之一是中國與美國的數據可翻譯性。那是——我們為它贏得了真正的榮譽，因為它具有顯著的可翻譯性。這顯然是一個非常動態的問題。

There was also the issue of bleeders in EGFR, and we certainly put that one to rest. There was also the issue of brain mets, something very serious that touched the members of my own family. We put that issue to rest. There was the bispecific, very novel, and you know we put that issue to rest. That would not have happened had the FDA not allowed us to move forward.

EGFR 中還存在出血問題，我們當然已經解決了這個問題。還有腦轉移的問題，這是一個非常嚴重的問題，影響了我的家人。我們已將這個問題擱置。有一種雙特異性物質，非常新穎，你知道我們解決了這個問題。如果 FDA 不允許我們繼續前進的話，這一切都不會發生。

In a continuation, our trials will probably always have China patients. It won't be two-thirds to one-third. It will be more like one-third to two-thirds. We are very, very pleased about that. But on the record, ivonescimab performed incredibly well. We had a progression-free survival hazard ratio of 0.52. We did better than any other drug in that marketplace. On the P-value, we had a 0.057. It did not pass muster.

今後，我們的試驗可能一直都會有中國患者。不會是三分之二比三分之一。大概是三分之一到三分之二。我們對此感到非常非常高興。但從記錄來看，ivonescimab 的表現非常好。我們的無惡化存活風險比為0.52。我們的表現比市場上任何其他藥物都要好。P 值為 0.057，不符合要求。

It is important to note that when you receive feedback from the FDA, it is the game you got to play. We played it. We needed 150 at least patients from outside of China, and we were able to get to 175. What really was not told was we underestimated the degree of difficulty to get the doctors to take this trial on. There was an inertia there. That inertia caused us to get off to a very slow start.

值得注意的是，當您收到 FDA 的回饋時，這就是您必須玩的遊戲。我們玩了它。我們需要至少 150 名來自中國以外的患者，而我們最終達到了 175 名。我們真正沒有意識到的是，我們低估了讓醫生接受這項試驗的困難。那裡存在著一種慣性。這種惰性導致我們起步非常緩慢。

So, we think as all that becomes incredibly available to others, they will look at it as a very successful human patient trial. We certainly appreciate the fact that the FDA allowed us to move forward on that. That gives you a little background on why we will submit. We feel we are a patient-based company, and we feel patients can benefit and did benefit, and we would like to see more of that. And the FDA will make the final decision.

因此，我們認為，隨著所有這些技術逐漸為其他人所用，他們會將其視為非常成功的人體患者試驗。我們非常感謝 FDA 允許我們繼續推進此事。這讓您了解我們提交的原因。我們覺得我們是一家以患者為本的公司，我們認為患者可以受益並且確實受益，我們希望看到更多這樣的情況。FDA 將做出最終決定。

There probably is not a USA agency today that has more respect around the world than the FDA, and we totally support that. So I hope that gives you a little bit of color as to we have made the investment, and we will make a further investment. And if it goes well and we get it in the patient’s hands, everybody will have a win on it. If it does not, we certainly have tried to make it go right.

如今，可能沒有哪個美國機構比 FDA 更受世界尊重，我們完全支持這一點。所以我希望這能讓您稍微了解我們已經進行的投資，我們也將進行進一步的投資。如果一切進展順利，我們將產品送到患者手中，那麼每個人都會從中受益。如果沒有，我們肯定會盡力使它順利進行。

Cory Kasimov, Evercore.

Cory Kasimov，Evercore。

Thanks for taking my question. I’m curious, was there something in the HARMONi-6 data that prompted the protocol amendments to HARMONi-3 beyond the kind of the staggered enrollment run rates? What impact will these changes have on the powering of the HARMONi-3 subsets? Thank you.

感謝您回答我的問題。我很好奇，除了交錯入學率之外，HARMONi-6 數據中是否存在某些內容促使對 HARMONi-3 協議進行修訂？這些變化會對 HARMONi-3 子集的供電產生什麼影響？謝謝。

Hey, Corey. This is Dave. Thanks for your question. I think there are multiple reasons in terms of updating the design of HARMONi-3. One, it accelerates our front-line lung cancer opportunity as a whole. Since we began enrolling the squamous cohort first, we believe that we’ll be able to complete enrollment in the first half of next year. This will allow for a data read-out in the second half.

嘿，科里。這是戴夫。謝謝你的提問。我認為更新 HARMONi-3 設計的原因有很多。首先，它加速了我們整體上一線肺癌治療的機會。由於我們首先開始招募鱗狀細胞癌患者，我們相信我們將能夠在明年上半年完成招募。這將允許在下半場讀取資料。

And because we’re rapidly enrolling the squamous cohort as well, we can complete that enrollment in the second half of next year. But two, it reduces regulatory risks. By separating the two histologies into individual ICT analyses, we do not risk the overall population being statistically significant, but one subgroup looking a little better than the other, mainly through sample variability. This could lead to risks regarding the approval for one histology or the other and so.

而且由於我們也快速招募鱗狀細胞癌患者，我們可以在明年下半年完成招募。其次，它降低了監管風險。透過將兩種組織學分離為單獨的 ICT 分析，我們不冒著總體人口具有統計顯著性的風險，但一個亞組看起來比另一個亞組稍好一些，這主要是透過樣本變異性實現的。這可能會導致有關一種組織學或另一種組織學的批准的風險等等。

Additionally, we’ve seen advisory committees from the FDA earlier this year that there’s an increased importance on the results of US patients, which becomes a subset of the two histologies. Without the change, US patients are effectively a subset of a subset at that point.

此外，我們今年稍早看到 FDA 的諮詢委員會表示，他們越來越重視美國患者的結果，而美國患者已成為兩種組織學的一個子集。如果沒有這種改變，那麼美國患者其實只是一個子集的子集。

Now we have individually powered squamous and separately powered non-squamous histologies for both primary endpoints of PFS and OS. They’re individually powered at the histology level now. Two ICTs. Separately powering the individual histologies is effectively a cleaner assessment of the data.

現在，我們針對 PFS 和 OS 兩個主要終點分別提供了鱗狀和非鱗狀組織學的單獨動力。現在它們在組織學層面上都是單獨供電的。兩個 ICT。單獨為各個組織學提供動力實際上可以更清晰地評估數據。

And three, it allows us to keep pace in non-squamous as well because given the PD-1 plus chemotherapy performs a little bit more favorably in non-squamous patients, i.e., you know, typically it has a longer overall survival than squamous patients.

第三，它使我們能夠跟上非鱗狀細胞癌的步伐，因為 PD-1 聯合化療在非鱗狀細胞癌患者中的效果更佳，也就是說，通常非鱗狀細胞癌患者的總體生存期比鱗狀細胞癌患者更長。

The progress and additional targeted therapies that we see in non-squamous mutations, variability, some historical results in non-squamous trials, we really want to ensure that there’s little statistical variability, like an overperforming control arm or something like that that can raise issues.

我們在非鱗狀突變、變異性以及非鱗狀試驗的一些歷史結果中看到的進展和額外的標靶治療，我們確實希望確保統計變異性很小，例如表現優異的對照組或類似情況可能會引發問題。

So again, we increase the sample size. Because we’re rapidly enrolling the cohort, the analysis is driven by a read-out of events. It’s an event-driven analysis. Increasing the sample size for non-squamous really has very little impact on the timing of the read-out there.

因此，我們再次增加樣本量。因為我們正在快速招募佇列，所以分析是透過讀取事件來驅動的。這是一個事件驅動的分析。增加非鱗狀細胞癌的樣本量對讀數的時間影響確實很小。

So we don’t see a change in probability of success in either of the opportunities. We view them both as being cleaner. However, really specifically to your question, Corey, with respect to what we saw with HARMONi-6 yesterday, what that does is allows for a direct read-through now to an ICT population in the HARMONi-3 study.

因此，我們認為這兩個機會的成功機率都沒有改變。我們認為它們都比較清潔。然而，科里，具體到你的問題，關於我們昨天在 HARMONi-6 上看到的情況，它的作用是允許直接讀取 HARMONi-3 研究中 ICT 人群的情況。

It’s effectively the same comparison now, ivonescimab plus chemo versus PD-1 plus chemo in the squamous population. It’s now just in a global setting instead of a single region in China. There is a direct read-through here. We’ve seen historical comparability in terms of the data generated in Asia versus the rest of the world. We’re very excited with the ability to have that direct read-through in accelerating that squamous opportunity by breaking out into two separate ITTs.

現在實際上是相同的比較，在鱗狀細胞癌人群中，ivonescimab 加化療與 PD-1 加化療進行比較。現在它只是處於全球環境中，而不是中國單一地區。這裡有一個直接的閱讀。我們已經看到了亞洲與世界其他地區產生的數據的歷史可比性。我們非常高興能夠透過分成兩個獨立的 ITT 來加速鱗狀細胞癌的直接讀取機會。

Mohit Bansal, Wells Fargo.

富國銀行的 Mohit Bansal。

Good. Thank you very much for taking my question and congrats on all the progress. One repeated question we get from experts is that when you compare a VEGF PD-1 to a PD-1, it is, or previous PD-1 VEGF combo, it is very clear that the VEGF component is better than the VEGF component that was tested before. But it’s not clear that if PD-1 component is better.

好的。非常感謝您回答我的問題，並祝賀您取得的所有進展。我們從專家那裡反覆得到的一個問題是，當您將 VEGF PD-1 與 PD-1 或​​先前的 PD-1 VEGF 組合進行比較時，很明顯 VEGF 成分比之前測試的 VEGF 成分更好。但尚不清楚 PD-1 成分是否更好。

Now, where do you stand on that? And if that is the case, isn’t that an issue for OS benefit here because it does seem like PD-1s are the ones which are causing the long or reducing the long tail in those trials. So I think that’s the biggest issue right now, if you could help us understand the confidence around OS here. Thank you. Yeah, this is Jack West.

現在，您對此持什麼立場？如果情況確實如此，那麼這對 OS 益處來說不是一個問題嗎？因為看起來 PD-1 確實是導致這些試驗中長尾效應或減少長尾效應的因素。所以我認為這是目前最大的問題，如果您能幫助我們了解這裡對作業系統的信心。謝謝。是的，這是傑克·韋斯特。

Yes. This is Jack West. I think, it’s difficult to impute too much into the value of one side of a molecule or another. We haven’t historically done that with other molecules that target MET and EGFR and say, well, you don’t dismiss or minimize that because, oh, this is just working on the MET side.

是的。這是傑克·韋斯特。我認為，很難將過多的因素歸咎於分子一側或另一側的價值。我們以前沒有對針對 MET 和 EGFR 的其他分子進行過這樣的研究，並且說，好吧，你不能忽視或輕視這一點，因為，哦，這只是在 MET 方面起作用。

I would say that the most important thing is we should see what the data show at the subsequent final ongoing reading. So if the efficacy is there and the tolerability is favorable, you look at the totality of the data and you decide whether that is enough to change from whatever your competing current standard is. And I don’t think that we have or should have a separate set of criteria for a presumption that this is working through a VEGF action or an immunotherapy action.

我想說最重要的是我們應該看看隨後的最終持續讀數中數據顯示出什麼。因此，如果療效確實存在且耐受性良好，您可以查看全部數據並決定是否足以改變當前的競爭標準。我認為我們沒有或不應該有一套單獨的標準來推測這是透過 VEGF 作用還是免疫療法作用。

I think we just make inferences. I think different clinicians or others make inferences based on their own suppositions or biases. So I would say that, yeah, I’m not sure it really matters. The reality is you look at the efficacy, you look at the tolerability, and you weigh all of that against what the current prevailing options and standards are.

我認為我們只是做出推論。我認為不同的臨床醫生或其他人會根據自己的假設或偏見做出推論。所以我想說，是的，我不確定這是否真的很重要。事實是，你要考慮療效，考慮耐受性，並將所有這些與當前流行的選擇和標準進行權衡。

And if it bubbles up as better, we have lots and lots of therapies that have a benefit that is not sustained over many, many, many years, and that’s still valuable. There are many different kinds of efficacy benefits that have varying degrees of appreciated utility to clinicians and patients.

如果它變得更好，我們就會有很多療法，這些療法的益處不會持續很多年，但仍然很有價值。有許多不同類型的療效益處，對臨床醫生和患者俱有不同程度的認可效用。

So I think I would focus more on what the actual clinical outcomes are than a supposition of which side of a molecule is more important in one setting or another.

因此，我認為我應該更專注於實際的臨床結果，而不是假設分子的哪一側在某種情況下更重要。

Yeah, William, I’ll add, this is Dr. Allen Yang. I’ll add that we’ve always been under the hypothesis that I think the data are showing that the two put together are cooperating and better than the sum of its parts. Akeso smartly designed this molecule such that the PD-1 and VEGF work together.

是的，威廉，我要補充一下，這是艾倫楊博士。我要補充一點，我們一直都假設，我認為數據表明，兩者結合起來是相互配合的，效果比各部分簡單相加更好。康方巧妙地設計了這種分子，使得 PD-1 和 VEGF 協同作用。

So the HARMONi-6 data reading out positive doesn’t indicate that it’s just the VEGF, and it’s not just an indication. But again, I think VEGF is important in a lot of different diseases, and this puts them together in a smart way.

因此，HARMONi-6 數據讀數呈陽性並不表明它只是 VEGF，而且它不僅僅是一個指示。但我再次認為 VEGF 在許多不同的疾病中都發揮著重要作用，而這以一種巧妙的方式將它們結合在一起。

If you look back to the HARMONi-2 data, remember, there was an improvement not only in the low PD-L1 expressing that was probably indicative of VEGF, but also the high PD-L1 expressing. This is the sweet spot for PD-1. The VEGF clearly makes it better. I think Dr. John Heymach also alluded to in the discussion of that that not only were they cooperating, but the VEGF may play a role in immunotherapy as well. There’s growing data to support that as well.

如果您回顧 HARMONi-2 數據，請記住，不僅低 PD-L1 表達有所改善（這可能表明 VEGF），而且高 PD-L1 表達也有所改善。這是 PD-1 的最佳點。VEGF 顯然會讓情況變得更好。我認為 John Heymach 博士在討論中也提到，他們不僅在合作，而且 VEGF 也可能在免疫療法中發揮作用。越來越多的數據也支持這一點。

So the answer to your question is we think, again, both sides are important, and how they’re engineered and put together indicates that the MOA is important. I also want to add that the safety that we’ve seen across four randomized double-blind placebo sites suggests that this is not VEGF.

所以對你的問題的回答是，我們認為雙方都很重要，而且它們的設計和組合方式表明了 MOA 的重要性。我還想補充一點，我們在四個隨機雙盲安慰劑試驗點看到的安全性表明這不是 VEGF。

Clara Dong, Jefferies.

克拉拉‧董 (Clara Dong)，傑富瑞 (Jefferies)。

Hi, guys. Thanks for taking my question and congrats on the impressive HARMONi-6 data. I think there’s a lot of great questions on HARMONi-6 already. So I want to actually talk about your plan for Colorectal cancer. So for the Phase III study, are there any plans to stratify or analyze outcomes based on the presence of liver versus non-liver mets, given some prevalent evidence of their impact on treatment responses in MSS CRC?

嗨，大家好。感謝您回答我的問題，並祝賀您獲得令人印象深刻的 HARMONi-6 數據。我認為 HARMONi-6 上已經有很多很棒的問題。所以我實際上想談談你針對大腸癌的計劃。那麼，對於 III 期研究，鑑於肝臟轉移和非肝臟轉移對 MSS CRC 治療反應的影響存在一些普遍證據，是否有計劃根據肝臟轉移和非肝臟轉移的存在對結果進行分層或分析？

And then you mentioned the global components of the Phase II FOLFOX combination study. What’s the expected timeline for the next step data and whether we should expect some US data from this trial in the next update as well? Thank you.

然後您提到了第二階段 FOLFOX 聯合研究的全球組成部分。下一步數據的預期時間表是什麼？我們是否也應該在下一次更新中期待來自該試驗的一些美國數據？謝謝。

Thanks, Clara. I think all good questions. I think we do, we certainly do have stratification factors within our current trial. I don’t think at this point quite this early we’re looking to make public all of those individual factors just yet. Your points are well taken in terms of the specific patient characteristics that you mentioned.

謝謝，克拉拉。我認為這些都是好問題。我認為我們確實存在，我們目前的試驗中確實存在分層因素。我認為，現在我們還不宜過早地公開所有這些單獨的因素。就您提到的具體患者特徵而言，您的觀點非常正確。

And I would say with respect to the publishing of additional data, including those data that were based on US patients, we’re determining the appropriate time if and when that’s, if and when we do that. In part of that is we continue to have Phase III read-outs that becomes important to prioritize that. Publishing data across multiple different chemotherapy lines for us or chemotherapy options is important for us to make decisions. It’s not necessarily something that we need to individually go through.

我想說的是，關於發布更多數據，包括基於美國患者的數據，我們正在確定合適的時間，如果我們這樣做的話，我們將這樣做。其中一部分原因是我們繼續進行第三階段的讀數，這對於優先考慮這一點很重要。發布多種不同化療方案或化療方案的數據對於我們做出決策非常重要。這不一定是我們需要單獨經歷的事情。

So, I think there’s a piece where the Phase III will become very important to publish. Obviously, our partners at Akeso are running a Phase III as well, which will provide significant additional context when that study concludes.

因此，我認為第三階段的發布將變得非常重要。顯然，我們在康方生物的合作夥伴也正在進行第三階段的研究，這將在該研究結束時提供重要的額外背景資訊。

Asthika Goonewardene, Truist Securities.

Asthika Goonewardene，Truist 證券公司。

Hey, guys. Thanks for taking my question. I’ll also offer my congrats on all the progress and the great data presented yesterday. To start off on HARMONi, the takeaway from World Lung was that your OS benefit would become more pronounced with the appropriate level of follow-up.

嘿，大家好。感謝您回答我的問題。我還要對昨天取得的所有進展和公佈的重要數據表示祝賀。首先從 HARMONi 開始，世界肺臟協會的結論是，透過適當的後續跟進，您的 OS 優勢將變得更加明顯。

So, with the HARMONi filing with the FDA, do you need to take a new data cut, or are you filing what you have right now? And then I have a follow-up.

那麼，在向 FDA 提交 HARMONi 文件時，您是否需要進行新的資料剪切，還是只提交您現有的資料？然後我有一個後續問題。

Yeah, thanks for the question, Ashteka, and appreciate the words at the beginning. I think we haven’t publicly spoken to the specific details with respect to how we’ll work with the agency. As Urte mentioned earlier, we maintain communication with the agency. It’s important to work through this submission process.

是的，謝謝你的提問，Ashteka，我很感謝你一開始說的話。我認為我們還沒有公開談論有關如何與該機構合作的具體細節。正如烏爾特之前提到的，我們與該機構保持溝通。完成這個提交過程非常重要。

And so, as she mentioned currently working on the application at this point. So I think that is clearly, just given where we are today, only a month and a half later from the data cut, based on what we saw at World Lung. I think. in terms of next steps with that, part of that will involve discussions with the agency.

正如她所提到的，目前正在處理該應用程式。因此，我認為，根據我們在世界肺臟大會上看到的情況，從數據截取到現在只有一個半月的時間，情況顯然如此。我認為，就下一步行動而言，其中一部分將涉及與該機構的討論。

Got it. Thanks. On the amendments to the HARMONi-3 study, the original HARMONi-3 study, which was originally restricted to -- just squamous patients, that had about a trial recruitment of about 400 or 450 patients or so. The HARMONi-6 data came out showing a really great benefit in checking a similar kind of patient population.

知道了。謝謝。關於 HARMONi-3 研究的修訂，最初的 HARMONi-3 研究最初僅限於鱗狀患者，試驗招募了大約 400 或 450 名患者左右。HARMONi-6 數據顯示，檢查類似患者群體確實有很大益處。

But now you’re expanding the recruitment for the HARMONi-3 squamous cohort to 600 patients. I know that’s also in line with what KEYNOTE-407 recruited. I just want to get your guys’ thoughts on the rationale for increasing the target size there.

但現在您正在將 HARMONi-3 鱗狀細胞癌隊列的招募範圍擴大到 600 名患者。我知道這也符合 KEYNOTE-407 招募的內容。我只是想了解你們對於增加目標規模的理由的看法。

-- I can respond to the site. I think they discussed it very carefully once. We are basically splitting the cohorts into two parts. There will be separate analysis, and it’s very important that we are powering for most endpoints for PFS and OS. This is a very good sample size. We have obviously high confidence in the regions of the squamous cohort. But this is appropriate to cover both endpoints.

——我可以回應該網站。我認為他們曾經非常仔細地討論過這個問題。我們基本上將群體分成兩部分。將會有單獨的分析，而且我們為 PFS 和 OS 的大多數端點提供動力非常重要。這是一個非常好的樣本量。我們顯然對鱗狀細胞群的區域有很高的信心。但這對於覆蓋兩個端點來說是合適的。

David Dai, UBS.

戴維戴，瑞銀。

Great. Hey, thanks for taking my questions. I also wanted to add my congrats on the great data here. I have a couple of questions. One is just a clarifying question on the HARMONi-3 Phase III trial update. So Dave, you mentioned that the trial update de-risked the regulatory aspects.

偉大的。嘿，謝謝你回答我的問題。我還想對這裡的出色數據表示祝賀。我有幾個問題。一個只是關於 HARMONi-3 第三階段試驗更新的澄清問題。戴夫，你提到試驗更新降低了監管的風險。

I just want to clarify that. Does that mean that you’re able to file each histology separately? Let’s say if one histology failed with yours, the other succeeds, does that mean you can file for the successful one irrespective of the failed histology?

我只是想澄清這一點。這是否意味著您能夠單獨歸檔每個組織學？假設您的一個組織學檢查失敗，而另一個組織學檢查成功，這是否意味著您可以申請成功的組織學檢查，而不管失敗的組織學檢查是什麼？

In short, David, yes. They’re independent IPTs. They’re independent analyses.

簡而言之，大衛，是的。它們是獨立的 IPT。它們是獨立的分析。

Got it. That’s great. You could just file. (multiple speakers)

知道了。太棒了。你可以直接提交。（多位發言者）

It’s just the nature of what is happening, so they will not read out exactly at the same time.

這只是正在發生的事情的本質，所以他們不會在同一時間讀出。

Got it. Okay. Great. Secondly, just on the combo strategies for, you know, for non-small cell. I know a lot of other companies that are thinking about doing ADCs and chemo combos. What are your thoughts around, like, combination strategies, with, you know, with ivonescimab, you know, in different solid tumors?

知道了。好的。偉大的。其次，僅討論非小型蜂巢的組合策略。我知道很多其他公司正在考慮生產 ADC 和化療組合。您對 ivonescimab 在不同實體瘤中的合併治療策略有何看法？

And David, I think you’re talking about novel, novel combinations if I understood that right. And so, I think we’ve talked about this a little bit in the past. We’re very excited in terms of our clinical trial collaboration with RepMed, in terms of evaluating multiple RAS inhibitors in combination with ivonescimab.

大衛，如果我理解正確的話，我想你說的是新穎的組合。所以，我想我們過去已經談論過這個問題了。我們對與 RepMed 的臨床試驗合作感到非常興奮，我們將評估多種 RAS 抑制劑與 ivonescimab 的聯合作用。

So I think we’ll be able to, you know, in collaboration with RepMed, begin dosing patients early in 2026. But in addition there to, I think we’re planning on multiple additional combinations. Those would likely be with ADCs too, where I think you were heading with that, David.

因此我認為我們將能夠與 RepMed 合作，並在 2026 年初開始為患者提供藥物。但除此之外，我認為我們還在計劃多種其他組合。這些很可能也與 ADC 有關，我認為你正朝著這個方向前進，大衛。

And so part of what we believe is a strategic advantage for Summit as a whole, ivonescimab, and the global development of ivonescimab, is because we don’t have specific ADCs that are part of our portfolio as well, it allows us to follow the data. So we’re working with multiple other companies in terms of collaborating in order to test ivonescimab in combination with multiple ADCs that are multiple targets with multiple different payloads, different structures.

因此，我們認為對於 Summit 整體、ivonescimab 以及 ivonescimab 的全球發展來說，部分策略優勢在於我們的產品組合中沒有特定的 ADC，這使我們能夠追蹤數據。因此，我們正在與多家其他公司合作，測試 ivonescimab 與多種 ADC 的結合效果，這些 ADC 具有多種目標、多種不同的有效載荷和不同的結構。

And that will allow us ultimately to follow the data. I think you’ve heard us speak to in the past. In reality, what we don’t believe in, similar to if you look at solid tumor therapy today, there is not a single chemotherapy or chemotherapy regimen that is applicable across solid tumors, right? There are different regimens that are applicable, even in non-small cell lung cancer. Pemetrexed is used very frequently in non-squamous tumors, and it is not used in squamous tumors. Paclitaxel is the backbone.

這最終將使我們能夠追蹤數據。我想您以前曾聽過我們的談話。事實上，我們不相信的是，就像你今天看實體瘤治療一樣，沒有一種化療或化療方案可以適用於所有實體腫瘤，對嗎？即使是非小細胞肺癌，也有不同的適用方案。培美曲塞在非鱗狀腫瘤中非常常用，在鱗狀腫瘤中不常用。紫杉醇是其支柱。

As we think about just within non-small cell lung cancer, key differences in terms of the chemo regimens. That implies as you keep going beyond into additional histologies and additional solid tumor settings, that certainly different payloads will be very important in terms of being most effective for the tumors in those settings.

當我們考慮非小細胞肺癌時，化療方案上有關鍵差異。這意味著，隨著您不斷深入其他組織學和其他實體腫瘤環境，不同的有效載荷對於在這些環境中對腫瘤最有效而言無疑非常重要。

And so the MOA will be very important. The safety will be very important. There are different tolerability thresholds within different tumors in different settings. And so what we want to do is follow the data. So what we won’t be is encumbered by maximizing our own internal pipeline if you will. We think there have been mistakes made in the past on that.

因此，MOA 非常重要。安全非常重要。不同環境下不同腫瘤的耐受閾值不同。所以我們要做的就是追蹤數據。因此，如果您願意的話，我們不會因為最大化我們自己的內部管道而受到阻礙。我們認為過去在這方面曾犯過錯。

We think we have the opportunity to follow the best data, follow the right combination with ivonescimab, and ultimately maximize the potential for patients in terms of what can be done to take the power of ivonescimab with some of the novel components that are in development that are exciting right now, whether it be a RAS inhibitor like RepMed has multiple RAS inhibitors or different ADCs with unique structures.

我們認為我們有機會遵循最佳數據，遵循與 ivonescimab 的正確組合，並最終最大限度地發揮患者的潛力，利用目前正在開發的一些令人興奮的新成分來發揮 ivonescimab 的功效，無論是像 RepMed 這樣的 RAS 抑製劑有多種 RAS 抑製劑還是具有獨特結構的不同 ADC。

Obviously, Akeso has multiple ADCs in their pipeline as well that they are going to be taking a look at, in particular in their own trials to start. That will also inform us going forward as well.

顯然，康方生物在其研發管線中也有多個 ADC，他們將對其進行研究，特別是在他們自己的試驗中。這也將為我們未來的行動提供指引。

Reni Benjamin, Citizens.

雷尼‧班傑明，《公民》。

Hey. Good morning, guys. Thanks for taking the questions. Congratulations on the very impressive data yesterday. I guess, the first question is the HARMONi-6 safety profile really reaffirms to us, like, ivonescimab’s, you know, tolerability, especially given it’s largely comparable, you know, with the control arm. Were there any specific, like, squamous specific, you know, related events that’s different from the non-squamous cohort in HARMONi?

嘿。大家早安。感謝您回答這些問題。恭喜你昨天取得的令人印象深刻的數據。我想，第一個問題是 HARMONi-6 的安全性確實向我們證實了 ivonescimab 的耐受性，特別是考慮到它與對照組具有很大的可比性。是否存在任何特定的、例如鱗狀細胞癌特有的相關事件，與 HARMONi 中的非鱗狀細胞癌群體不同？

Related to that, I think there’s just an apparent kind of underappreciation for the safety profile, specifically bleeding. I think the discussant brought that up. I’m kind of curious as to how you guys are addressing that, especially with KOLs.

與此相關，我認為人們顯然低估了安全性，特別是出血。我認為討論者已經提到了這一點。我有點好奇你們是如何解決這個問題的，尤其是針對 KOL。

This is Dr. H. Jack West. I would say there’s differences between the squames and the non-squames, largely based on the characteristics. Squamous tumors tend to be larger and more central than non-squamous tumors. And then the fraction of, proportion of brain metastases is present. There are some in HARMONi-6 and in other squamous cohorts. It’s far less common in patients with squamous than with adenocarcinoma, and especially patients with EGFR mutation positive non-small cell where brain metastases are a leading concern.

我是 H. Jack West 博士。我想說的是，鱗狀細胞癌和非鱗狀細胞癌之間存在差異，這主要基於其特徵。鱗狀腫瘤往往比非鱗狀腫瘤更大且更位於中心。然後是腦轉移的比例。HARMONi-6 和其他鱗狀細胞群中也存在一些。與腺癌相比，鱗狀細胞癌患者患有此病的幾率要低得多，尤其是 EGFR 突變陽性非小細胞癌患者，腦轉移是主要關注點。

But I would say, as I had alluded and the presentation yesterday as well, this is not just allowing patients with advanced squamous lung cancer, but this was bold and courageous in enrolling patients with several features that have historically been challenging, if not prohibitive, with Bevacizumab. Frankly, in China, they have years of experience, many of these investigators, and growing comfort with that.

但我想說，正如我昨天提到的以及在演講中提到的，這不僅允許患有晚期鱗狀肺癌的患者，而且在招募具有貝伐單抗歷史上具有挑戰性（如果不是禁止的話）的幾個特徵的患者方面是大膽和勇敢的。坦白說，在中國，他們擁有多年的經驗，許多調查人員對此越來越放心。

I would say that clinical oncologists outside of China or anywhere where they have less experience will need to not only look at these data. It’s definitely going to be a point of education that we cannot be limited by and should not be limited by the historical precedence of a different drug with a very different safety profile. These are new times. and the eligibility should be very different and liberalized.

我想說的是，中國以外或任何經驗較少的地方的臨床腫瘤學家需要做的不僅僅是查看這些數據。這絕對是一個教育要點，我們不能受其限制，也不應該受具有非常不同安全性的不同藥物的歷史先例的限制。這是新時代，資格應該有很大不同並且更加自由化。

And yet, I think that it will take both the combination of education and gradual experience for oncologists to get it, treat patients, and be reassured by their own favorable experiences with it over time.

然而，我認為腫瘤學家需要結合教育和逐漸累積的經驗才能掌握它、治療患者，並隨著時間的推移透過自己的良好體驗獲得信心。

Got it. And then just as a follow-up, do you think that the filing is the FDA kind of indicated that this goes to ODAC? Will you be applying for accelerated or full approval? Your thoughts on European filings? Thank you.

知道了。然後作為後續問題，您是否認為該文件是 FDA 的暗示，表明這是交給 ODAC 的？您會申請加速批准還是完全批准？您對歐洲申請的看法？謝謝。

Yes. We think this is a good, solid package. We have a statistically significant PFS. We have supportive OS data, which we think is very meaningful and will be evaluated in context. We have supportive efficacy data from OR and duration of response. So all of this is basically a good, suitable package for full approval.

是的。我們認為這是一個好的、可靠的方案。我們有一個具有統計意義的 PFS。我們有支持性的 OS 數據，我們認為這些數據非常有意義，並將根據具體情況進行評估。我們有來自 OR 和反應持續時間的支持性療效數據。因此，所有這些基本上都是好的、適合全面批准的方案。

We cannot foresee what exactly the comments and the opinions of the FDA are. As we said, as we go into this review process, if specific information emerges, then we will provide color on that. Other policy issues I cannot comment on. We look forward to the FDA and not sharing with us what their plans are in terms of external feedback and those kinds of things. We will be watching that along with you.

我們無法預見 FDA 的評論和意見究竟是什麼。正如我們所說，當我們進入審查過程時，如果出現具體信息，那麼我們將對此進行詳細說明。其他政策問題我無法評論。我們期待 FDA 與我們分享他們在外部反饋和諸如此類的事情方面的計劃。我們將與您一起關注此事。

Mitchell Kapoor, H.C. Wainwright.

米切爾·卡普爾、H.C. 溫賴特。

Hi, everyone. Thanks for taking the questions and congrats on the data. Can you point to relevant regulatory precedence where a strong PFS benefit without a statistically significant OS benefit at the time of filing was still sufficient for FDA approval?

大家好。感謝您回答問題並祝賀您獲得這些數據。您能否指出相關的監管先例，即在提交申請時，即使沒有統計上顯著的 OS 優勢，強大的 PFS 優勢也足以獲得 FDA 批准？

And how do you think that or can you just remind us how these situations were handled by the FDA? And then separately, can you just comment on this business development front on the change in the volume and the types of BD discussions you’ve been having lately? Thank you.

您對此有何看法？或者您能否提醒我們 FDA 是如何處理這些情況的？然後另外，您能否就業務發展方面最近進行的 BD 討論的數量和類型的變化發表評論？謝謝。

I will take the first part. In this exact setting, meaning in EGFR positive previously treated patients, there were two relevant approvals. Both of them occurred last year. The first one is for the [Ivonescimab] molecule based on the MERKLCET2 study, which was approved on statistically significant PFS and was accompanied by a positive trend, but not significant in OS.

我將講第一部分。在這種確切的環境中，即在 EGFR 陽性且接受過治療的患者中，有兩項相關批准。這兩起事件都發生在去年。第一個是基於 MERKLCET2 研究的 [Ivonescimab] 分子，該分子在統計上具有顯著的 PFS 獲得批准，並伴隨正向趨勢，但在 OS 方面並不顯著。

The other approval that happened as an accelerated approval is the [DataDEX] molecule. In the wording, it is slightly different, but it’s previously treated patients with both chemo as well as PK therapy, EGFR therapy. That accelerated approval was based on ORR with the durational response.

另一項以加速核准方式獲得的核准是 [DataDEX] 分子。在措辭上略有不同，但它是先前用化療以及 PK 療法、EGFR 療法治療過的患者。此加速批准是基於 ORR 和持續反應。

And I can also note that the confirmatory study for that molecule in EGFR positive is in the frontline setting. There isn’t going to be any additional generation of statistically significant PFS or OS in that setting forthcoming.

我也可以指出，針對 EGFR 陽性的該分子的驗證性研究處於第一線環境。在這種情況下，不會再出現任何具有統計意義的 PFS 或 OS 的額外產生。

Business development question? Bob, do you want to conclude with the business development?

業務發展問題？鮑勃，你想結束一下業務發展嗎？

I think that answers the questions. This is Bob Duggan. We want to thank you for your attendance today. I only wish you could be at ESMO. There are at least 25,000 people here. We were really honored, and Akeso was honored to be the first presenter at the presidential presentation. There were 9,000 people packed into a very large auditorium. They gave a resounding applause as they heard the data.

我想這回答了這些問題。這是鮑伯·杜根。我們感謝您今天的出席。我只希望你能加入 ESMO。這裡至少有25,000人。我們感到非常榮幸，康方生物也很榮幸能夠成為總統演講的第一位演講者。一座非常大的禮堂裡擠滿了 9,000 人。當他們聽到這些數據時，發出了熱烈的掌聲。

This is a breakthrough. It’s a breakthrough of magnitude. Undeniably, we have an excellent product. Lung cancer is the number one killer. It’s not going to be that way for long. We really are in the mitigation, and hopefully, in some areas, we’ll move this forward even into the arena of clear.

這是一個突破。這是一個重大的突破。不可否認，我們擁有一款優秀的產品。肺癌是頭號殺手。但這種情況不會持續太久。我們確實在採取緩解措施，並且希望在某些領域，我們能夠進一步推進，甚至進入明確的階段。

Our team is very excited. We’re very excited to have the product in our hands. The doctors, physicians, and those that support them are really excited. We see them in the hallways and in other meetings. We’ve been just packed with attendance and appreciation. You have to kind of be here to see it. It’s my first trip to Berlin, but I must say it’s a beautiful city, even though it’s a bit nippy for someone that lives in Miami.

我們的團隊非常興奮。我們非常高興能夠收到該產品。醫生、醫師以及支持他們的人都非常興奮。我們在走廊和其他會議上看到他們。我們這裡擠滿了出席者和欣賞者。您必須親臨現場才能看到它。這是我第一次去柏林，但我必須說這是一個美麗的城市，儘管對於住在邁阿密的人來說它有點冷。

So we’re going straight ahead here, and we’re enjoying ourselves. The future looks incredibly bright. Opportunities like this, I haven’t seen in my brief investment lifetime. I’m just really excited about helping patients here and making a significant difference for the betterment.

所以我們就在這裡繼續前進，享受生活。未來看起來無比光明。在我短暫的投資生涯中，我從未見過這樣的機會。我真的很高興能夠幫助這裡的病人並為他們帶來顯著的改善。

I will say you see people from all cultures, all walks of life here. This healthcare business is one that brings the world together, not separates it. And We’re just really happy to play a significant role and thankful to our Akeso partners from China and to the FDA for giving us the platform in which to really move forward.

我想說，在這裡你會看到來自各種文化、各行各業的人。醫療保健事業將世界連結在一起，而不是分裂世界。我們非常高興能夠發揮重要作用，並感謝來自中國的康方合作夥伴和 FDA 為我們提供了一個真正向前發展的平台。

So, thank you for being on the call. Looking forward to talking to you soon. Have a great day.

感謝您接聽電話。期待很快與您交談。祝你有美好的一天。

Ladies and gentlemen, that concludes today’s call. You can disconnect. Thank you and have a great day.

女士們、先生們，今天的電話會議到此結束。您可以斷開連線。謝謝您，祝您有愉快的一天。