Summit Therapeutics Inc (SMMT) 2024 Q2 法說會逐字稿

Good morning and welcome to Summit Therapeutics second-quarter 2024 earnings and update call. (Operator Instructions) Please note that today's call is being recorded.

早安，歡迎參加 Summit Therapeutics 2024 年第二季財報和更新電話會議。（操作員說明）請注意，今天的通話正在錄音。

And at this time, I would like to turn the call over to Dave Gancarz, Summit Therapeutics' Chief Business and Strategy Officer. You may proceed.

此時，我想將電話轉給 Summit Therapeutics 首席業務和策略長 Dave Gancarz。您可以繼續。

Good morning and thank you for joining us. Our press release was issued earlier this morning and is available on the homepage of our website. Our Form 10-Q was also filed earlier this morning and is available on our website. Today's call is being simultaneously webcast, and an archived replay will also be made available later today on our website, www.smmttx.com.

早安，感謝您加入我們。我們的新聞稿於今天早上早些時候發布，可在我們網站的主頁上找到。我們的 10-Q 表格也在今天早上早些時候提交，並可在我們的網站上取得。今天的電話會議同時進行網路直播，存檔重播也將於今天稍晚在我們的網站 www.smmttx.com 上提供。

Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer; Dr. Maky Zanganeh, our Chief Executive Officer and President; Manmeet Soni, our Chief Operating Officer and Chief Financial Officer; and Dr. Allen Yang, our Chief Medical Officer.

今天和我一起參加電話會議的是我們的董事會主席兼執行長鮑勃杜根 (Bob Duggan)； Maky Zanganeh 博士，我們的執行長兼總裁； Manmeet Soni，我們的營運長兼財務長；和我們的首席醫療官楊艾倫博士。

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 may 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可能提出的問題的一些答复可能會被視為基於我們當前預期的前瞻性聲明。

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. Following comments from Bob, Maky, Manmeet, we will take questions.

Summit 警告稱，這些前瞻性陳述存在風險和不確定性，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。請參閱我們向 SEC 提交的文件，以了解有關這些風險和不確定性的資訊。除法律要求外，峰會不承擔更新這些前瞻性聲明的義務。根據 Bob、Maky、Manmeet 的評論，我們將回答問題。

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

有了這個，我想把電話轉給鮑伯。

Thank you, Dave. Good morning, everyone, and thank you for joining us today. We are very proud of the recent accomplishments of Team Summit and the expanding positive information that continues to be brought to light surrounding ivonescimab, our lead investigational asset.

謝謝你，戴夫。大家早安，感謝您今天加入我們。我們對團隊高峰會最近的成就以及圍繞我們的主要研究資產 ivonescimab 不斷曝光的不斷擴大的積極訊息感到非常自豪。

The past few months have been pivotal to the positive development and awareness of ivonescimab as well as in expanding physician, caretaker, hospital, payer and patient awareness of Summit Therapeutics' mission and vision, namely to build a viable organization that makes a significant positive difference for the betterment of patients encountering serious unmet oncology medical needs.

過去幾個月對於 ivonescimab 的積極發展和認識以及擴大醫生、護理人員、醫院、付款人和患者對 Summit Therapeutics 使命和願景的認識至關重要，即建立一個能夠產生重大積極影響的可行組織為了改善遇到嚴重未滿足的腫瘤醫療需求的患者。

Specifically, ivonescimab created positive Phase 3 data updates from HARMONi-A and HARMONi-2, both of which were randomized single region clinical trials in non-small cell lung cancer conducted by our partners at Akeso. HARMONi-A results supported ivonescimab receiving its first regulatory approval in China for patients with advanced non-small cell lung cancer who have progressed following an EGFR-TKI.

具體來說，ivonescimab 從 HARMONi-A 和 HARMONi-2 中獲得了積極的 3 期數據更新，這兩項試驗都是由我們在康方生物的合作夥伴進行的非小細胞肺癌隨機單區域臨床試驗。HARMONi-A 結果支持 ivonescimab 在中國獲得首次監管批准，用於治療 EGFR-TKI 後病情進展的晚期非小細胞肺癌患者。

In HARMONi-2, ivonescimab monotherapy beat pembrolizumab monotherapy head-to-head in the study's primary endpoint of PFS, making ivonescimab the first drug to achieve a clinically meaningful efficacy benefit over pembrolizumab in a randomized Phase 3 clinical trial in non-small cell lung cancer. Additional data from this prespecified interim analysis will be presented at an upcoming major medical conference this quarter.

在HARMONi-2 中，ivonescimab 單藥療法在研究的主要PFS 終點中擊敗了pembrolizumab 單藥療法，這使得ivonescimab 成為第一個在非小細胞肺隨機3 期臨床試驗中相對於pembrolizumab 實現具有臨床意義的療效獲益的藥物癌症。來自預先指定的中期分析的更多數據將在本季度即將召開的大型醫學會議上公佈。

In addition, we raised an unsolicited $200 million at a premium over the then current market price, extending our cash runway and increasing our resources to execute our expansive goals. Manmeet will provide more details about our financial position in a few minutes.

此外，我們還以高於當時市場價格的溢價主動籌集了 2 億美元，擴大了我們的現金跑道並增加了我們的資源來實現我們的宏偉目標。Manmeet 將在幾分鐘內提供有關我們財務狀況的更多詳細資訊。

Summit's 2 multiregional registrational Phase 3 non-small cell lung cancer trials, HARMONi and HARMONi-3 continue to enroll. HARMONi remains on track to complete its planned enrollment later this year. Alongside our partners at Akeso, ivonescimab data was featured at ASCO as well as HARMONi-A data being published in JAMA, Journal of American Medical Association.

Summit 的 2 個多區域註冊 3 期非小細胞肺癌試驗 HARMONi 和 HARMONi-3 繼續入組。HARMONi 仍有望在今年稍後完成計劃的招生。與 Akeso 的合作夥伴一起，ivonescimab 數據在 ASCO 上得到專題報導，HARMONi-A 數據也在 JAMA（美國醫學會雜誌）上發表。

This, in addition to smaller conferences and best of ASCO follow-up meetings have been excellent in fostering KOL discussions regarding the future of cancer therapy, including the potential for ivonescimab. These efforts were further bolstered as we continue to ramp our investigator-sponsored trial or IST program.

除了小型會議和最好的 ASCO 後續會議之外，這在促進 KOL 關於癌症治療的未來（包括 ivonescimab 的潛力）的討論方面也發揮了出色的作用。隨著我們繼續加強研究者資助的試驗或 IST 計劃的力度，這些努力得到了進一步加強。

Last month, we announced a five-year strategic collaboration with MD Anderson to accelerate development of ivonescimab to the opportunity to conduct multiple clinical trials with one of the world's most respected medical health care institutions.

上個月，我們宣布與 MD 安德森進行為期五年的策略合作，以加速 ivonescimab 的開發，以便有機會與世界上最受尊敬的醫療保健機構之一進行多項臨床試驗。

These efforts are in addition to our continued collaboration with our partners at Akeso who continue to generate patient positive data in Phase 2 settings in both lung cancer and solid tumors outside of lung cancer, data which can help support additional late-stage clinical trials. These accomplishments have been foundational to our 2024 goals of successfully executing on our registrational Phase 3 trials while expanding our clinical development program.

除了這些努力之外，我們還與康方生物的合作夥伴繼續合作，康方生物繼續在肺癌和肺癌以外的實體瘤的二期臨床試驗中生成患者陽性數據，這些數據可以幫助支持更多的後期臨床試驗。這些成就是我們 2024 年目標的基礎，即成功執行我們的註冊 3 期試驗，同時擴大我們的臨床開發計畫。

Maky will further expound upon these accomplishments, including additional strides we have made to drive our firm continued belief and conviction in Team Summit and the potential of ivonescimab in non-small cell lung cancer and beyond.

Maky 將進一步闡述這些成就，包括我們為推動我們對 Team Summit 的堅定持續信念和信念以及 ivonescimab 在非小細胞肺癌及其他疾病中的潛力而取得的額外進展。

We are an experienced mission-driven organization with a collection goal to improve quality of life, increase potential duration of life, and resolve serious unmet medical need. We believe we have the right team and the right molecule in ivonescimab to help us realize this goal.

我們是一家經驗豐富、使命驅動的組織，其收集目標是改善生活品質、延長潛在壽命並解決嚴重的未滿足的醫療需求。我們相信我們擁有合適的團隊和合適的 ivonescimab 分子來幫助我們實現這一目標。

With that, I will turn the call over to Maky for additional context and recent highlights for consideration.

至此，我將把電話轉給 Maky，以了解更多背景資訊和最近的亮點以供考慮。

Thank you, Bob, and good morning, everyone. As Bob mentioned, I remain incredibly enthusiastic about the accomplishments of Team Summit and our partnership with Akeso. Before touching on the clinical highlights of ivonescimab, I would like to speak to the expansive clinical development work we have conducted with ivonescimab.

謝謝你，鮑勃，大家早安。正如鮑伯所提到的，我對團隊高峰會的成就以及我們與康方的合作關係仍然充滿熱情。在談到 ivonescimab 的臨床亮點之前，我想談談我們用 ivonescimab 進行的廣泛的臨床開發工作。

Between Summit and Akeso, over 1,800 patients have been treated with ivonescimab in clinical studies to date worldwide. There have been 20 clinical trials around the globe evaluating ivonescimab. While our Phase 3 programs across Summit and Akeso are currently focused in non-small-cell lung cancer, seven of the clinical trials for ivonescimab are evaluating our lead candidate in solid tumor settings beyond non-small cell lung cancer.

迄今為止，Summit 和 Akeso 之間已有超過 1,800 名患者在臨床研究中接受了 ivonescimab 的治療。全球已有 20 項臨床試驗評估 ivonescimab。雖然我們的 Summit 和 Akeso 的 3 期計畫目前專注於非小細胞肺癌，但 ivonescimab 的 7 項臨床試驗正在評估我們在非小細胞肺癌以外的實體瘤環境中的主要候選藥物。

Of course, we are sponsoring two clinical trials, both of which are Phase 3 studies: HARMONi and HARMONi-3. As a reminder, ivonescimab is the only PD-1 VEGF bispecific antibody in Phase 3 in our licensed territories. Ivonescimab brings these two highly validated mechanism of action together into one novel molecule targeting simultaneously both PD-1 and VEGF.

當然，我們贊助了兩項臨床試驗，皆為 3 期研究：HARMONi 和 HARMONi-3。提醒一下，ivonescimab 是我們許可地區唯一處於 3 期階段的 PD-1 VEGF 雙特異性抗體。Ivonescimab 將這兩種經過高度驗證的作用機制結合在一起，形成一種同時靶向 PD-1 和 VEGF 的新型分子。

Next, I would like to review our recent achievements as well as touch on some upcoming catalysts for the remainder of this year. As a reminder, our partnership with Akeso became effective at the beginning of 2023. At the time, Akeso was enrolling or completing enrollment in two Phase 3 clinical trials.

接下來，我想回顧一下我們最近的成就，並談談今年剩餘時間即將到來的一些催化劑。謹此提醒，我們與康方生物的合作關係於 2023 年初生效。當時，康方生物正在招募或完成兩項3期臨床試驗。

We immediately got to work and enrolled our first patient in HARMONi in the first half of 2023, began HARMONi-3 enrollment in the fourth quarter of 2023 and helped to ensure ivonescimab was featured at several medical conferences. The second quarter of 2024 was a pivotal moment for ivonescimab and its development with two major catalyst events occurring around the time of the ASCO 2024 conference.

我們立即開始工作，並於 2023 年上半年將第一位患者納入 HARMONi，並於 2023 年第四季度開始招募 HARMONi-3，並幫助確保 ivonescimab 在多個醫學會議上得到專題報道。2024 年第二季是 ivonescimab 及其開發的關鍵時刻，在 ASCO 2024 會議期間發生了兩起重大催化劑事件。

Ivonescimab received marketing approval in China supported by Akeso HARMONi-A Phase 3 clinical trial for patients with advanced non-small cell lung cancer who progressed following an EGFR-TKI. This data was subsequently featured in an oral presentation at ASCO and the HARMONi-A study was published in the Journal of American Medical Association or JAMA.

Ivonescimab 在康方生物 HARMONi-A 3 期臨床試驗的支持下在中國獲得上市許可，該試驗針對接受 EGFR-TKI 治療後病情進展的晚期非小細胞肺癌患者。該數據隨後在 ASCO 的口頭報告中得到專題報導，並且 HARMONi-A 研究發表在《美國醫學會雜誌》或 JAMA 上。

We also announced that HARMONi-2 met its primary endpoint of progression-free survival in prespecified interim analysis in which ivonescimab monotherapy in a head-to-head trial against pembrolizumab monotherapy achieved a statistical significant and clinically meaningful benefit in patients in China with first-line non-small can lung cancer patients whose tumors were positive for PD-L1 expression.

我們還宣布，HARMONi-2 在預先指定的中期分析中達到了無進展生存期的主要終點，其中在一項針對派姆單抗單藥治療的頭對頭試驗中，ivonescimab 單藥治療在中國患有首次-腫瘤 PD-L1 表達呈陽性的非小細胞肺癌患者。

Improvements in PFS was observed broadly across subgroups, including PD-L1 low and PD-L1 high expressing tumors as well as squamous and non-squamous histologies. We look forward to having additional HARMONi-2 data presented at a major medical conference this quarter.

在亞組中廣泛觀察到 PFS 的改善，包括 PD-L1 低表達和 PD-L1 高表達腫瘤以及鱗狀和非鱗狀組織學。我們期待在本季度的一次重要醫學會議上公佈更多 HARMONi-2 數據。

Looking to the remainder of 2024. In addition to the HARMONi-2 data readout, we plan to complete enrollment in our multiregional HARMONi trial later this year and expect additional Phase 2 data in lung and non-lung indications to be presented at multiple medical conferences in the coming months, including the World Conference on lung cancer and ESMO.

展望 2024 年剩餘時間。除了HARMONi-2 數據讀出之外，我們還計劃在今年稍後完成多區域HARMONi 試驗的入組，並預計肺和非肺適應症的更多2 期數據將在未來幾個月的多個醫學會議上公佈，包括世界肺癌會議和 ESMO。

ESMO recently released abstract titles featuring ivonescimab in Phase 2 studies in triple-negative breast cancer, colorectal cancer and head and neck cancer. We are fortunate to have created such a strong partnership in our ongoing collaboration with Akeso as we leverage data from multiple solid tumor studies supporting and informing Summit's own late-stage clinical development strategy in our licensed territories.

ESMO 最近發布了關於三陰性乳癌、大腸癌和頭頸癌 2 期研究中 ivonescimab 的摘要標題。我們很幸運能夠在與康方生物的持續合作中建立如此牢固的合作夥伴關係，因為我們利用多項實體瘤研究的數據來支持和告知 Summit 在我們許可地區的後期臨床開發策略。

With meaningful updates from Akeso HARMONi-A and HARMONi-2 occurring this past quarter, we wanted to take the opportunity on this quarter's earnings call to review both Phase 3 study design and highlight some key results.

隨著康方 HARMONi-A 和 HARMONi-2 上個季度發生的有意義的更新，我們希望利用本季度的財報電話會議的機會來審查第 3 階段的研究設計並強調一些關鍵結果。

Starting with HARMONi-A. This is a double-blinded placebo-controlled single region randomized Phase 3 trial evaluating ivonescimab plus chemotherapy versus placebo plus chemotherapy for patients with advanced or metastatic EGFR-mutant non-small cell lung cancer and disease progression after EGFR-TKI treatment. 322 patients were enrolled across 55 study sites in China and patients were stratified for exposure to third-generation EGFR-TKI treatment and the presence of brain metastases.

從 HARMONi-A 開始。這是一項雙盲安慰劑對照單區域隨機 3 期試驗，評估 ivonescimab 加化療與安慰劑加化療對晚期或轉移性 EGFR 突變非小細胞肺癌患者以及 EGFR-TKI 治療後疾病進展的影響。中國 55 個研究中心招募了 322 名患者，並對患者進行第三代 EGFR-TKI 治療暴露和腦轉移進行分層。

As a reminder, approximately 85% of HARMONi-A patients are intended to be included in our own HARMONi study analysis, representing those patients in HARMONi-A, who received a third-generation EGFR-TKI prior to entering the trial.

提醒一下，大約 85% 的 HARMONi-A 患者打算納入我們自己的 HARMONi 研究分析中，代表 HARMONi-A 中在進入試驗前接受第三代 EGFR-TKI 的患者。

In HARMONi-A, the primary endpoint of progression-free survival per independent radiologic review committee was met achieving a PFS hazard ratio of 0.46, representing a 54% reduction in the risk of disease progression or death compared to chemotherapy.

在 HARMONi-A 中，達到了獨立放射學審查委員會無進展生存的主要終點，PFS 風險比為 0.46，這意味著與化療相比，疾病進展或死亡風險降低了 54%。

Additionally, the subgroup of patients receiving a third-generation EGFR-TKI like osimertinib experienced a reduced risk of disease progression or death of 52% or hazard ratio of 0.48 as our HARMONi trial enrollment is expected to complete in the second half of this year.

此外，由於我們的HARMONi 試驗入組預計將於今年下半年完成，接受奧希替尼等第三代EGFR-TKI 治療的患者亞組的疾病進展或死亡風險降低了52%，風險比降低至0.48 。

We remain strongly encouraged by the opportunity for ivonescimab. In addition, an overall survival analysis of the HARMONi-A data was requested by the Chinese Regulatory Authority as a part of its review of ivonescimab for marketing approval in China. At 52% data maturity median overall survival in the ivonescimab arm showed a positive survival trend with a hazard ratio of 0.80.

我們仍然對 ivonescimab 的機會感到強烈鼓舞。此外，中國監管機構要求對 HARMONi-A 數據進行整體生存分析，作為 ivonescimab 在中國上市審批審查的一部分。當數據成熟度為 52% 時，ivonescimab 組的中位總存活期顯示出正向的存活趨勢，風險比為 0.80。

Ivonescimab was well tolerated and demonstrated a manageable safety profile. Treatment-related adverse events leading to discontinuation were 5.6% in the treatment arm compared to 2.5% in the placebo arm, and there were no deaths reported in either arm.

Ivonescimab 具有良好的耐受性並表現出可控的安全性。治療組中導致停藥的治療相關不良事件發生率為 5.6%，而安慰劑組為 2.5%，兩組均未通報死亡情形。

Grade 3 or higher immune-related adverse events were reported in 6.2% of patients in the treatment arm versus 2.5% of patients in the placebo arm. Grade 3 or higher potential VEGF-related adverse events were reported in 3.1% of patients in the treatment arm versus 2.5% of patients in the placebo arm. There were no grade 3 or higher bleeding events observed in either arm.

治療組中 6.2% 的患者報告了 3 級或更高等級的免疫相關不良事件，而安慰劑組則為 2.5%。治療組中 3.1% 的患者報告了 3 級或更高等級的潛在 VEGF 相關不良事件，而安慰劑組則為 2.5%。兩組均未觀察到 3 級或以上出血事件。

Moving to HARMONi-2, this Akeso sponsored study in a single region multicenter double-blinded randomized Phase 3 trial evaluating monotherapy ivonescimab head-to-head against monotherapy pembrolizumab as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have positive PD-L1 expression or a TPS score of greater than 1%.

轉向 HARMONi-2，這項康方生物贊助的單區域多中心雙盲隨機 3 期試驗，評估單一療法 ivonescimab 與單一療法 pembrolizumab 作為局部晚期或轉移性非小細胞肺患者的一線治療腫瘤PD-L1 表達陽性或TPS 評分大於1% 的癌症。

Patients in the study are stratified by PD-L1 low or TPS scores for 1 to 49% and PD-L1 high or TPS score of 50% or greater squamous versus non-squamous histology and stage of disease. HARMONi-2 primary input is progression-free survival as measured by Independent Radiologic Review Committee.

研究中的患者根據PD-L1 低或TPS 評分為1% 至49% 以及PD-L1 高或TPS 評分為50% 或更高進行分層，鱗狀細胞與非鱗狀細胞的組織學和疾病階段。HARMONi-2 的主要輸入是由獨立放射學審查委員會測量的無惡化存活期。

In high-level results for HARMONi-2, ivonescimab demonstrated a statistically significant, clinically meaningful improvement in progression-free survival over pembrolizumab. This benefit was observed across patient subgroup, including PD-L1 low, PD-L1 high, squamous and non-squamous histologies as well as other high-risk patients.

在 HARMONi-2 的高水準結果中，與派姆單抗相比，ivonescimab 在無惡化存活期方面顯示出統計學上顯著且具有臨床意義的改善。這種益處在患者亞群中觀察到，包括 PD-L1 低、PD-L1 高、鱗狀和非鱗狀組織學以及其他高風險患者。

Notably, no other randomized Phase 3 clinical trials in non-small cell lung cancer have demonstrated a statistically significant improvement in progression-free survival in head-to-head setting versus pembrolizumab. As mentioned previously, we are eager to share more information when the HARMONi-2 interim analysis data set is presented at an upcoming major medical conference this quarter.

值得注意的是，沒有其他針對非小細胞肺癌的隨機 3 期臨床試驗表明，與派姆單抗相比，頭對頭治療中的無進展生存期具有統計學上的顯著改善。如前所述，當 HARMONi-2 中期分析資料集在本季即將召開的大型醫學會議上發佈時，我們渴望分享更多資訊。

The PD-L1 subgroups as well as the subgroups by histology are important in terms of informing next steps in our clinical development pathway for indication both within lung and beyond lung. We had many highlights this past quarter and touched on most of them already, but would like to mention our five-year strategic collaboration with the MD Anderson Cancer Center that was announced last month in which the development of ivonescimab will be accelerated in several solid tumor types across multiple studies.

PD-L1 亞組以及按組織學分類的亞組對於為我們肺內和肺外適應症的臨床開發途徑的後續步驟提供資訊非常重要。上個季度我們有很多亮點，並且已經談到了其中的大部分，但想提一下我們上個月宣布的與 MD 安德森癌症中心的五年戰略合作，其中將加速 ivonescimab 在多種實體瘤中的開發多項研究的類型。

MD Anderson will lead this clinical trials to evaluate the safety and potential clinical benefit of ivonescimab, including the possibility of identifying biomarkers through additional research activities. Early work may include renal cell carcinoma, colorectal cancer, skin cancer, breast cancer and glioblastoma. The partnership has the potential to rapidly expand ivonescimab's development program.

MD 安德森將領導這項臨床試驗，以評估 ivonescimab 的安全性和潛在臨床益處，包括透過其他研究活動識別生物標記的可能性。早期工作可能包括腎細胞癌、大腸癌、皮膚癌、乳癌和膠質母細胞瘤。此次合作有可能迅速擴大 ivonescimab 的開發計畫。

We expanded our licensed territories to include Latin America, including Mexico and all countries in Central America, South America and the Caribbean, the Middle East and Africa; in addition to our original license territories, which include the US, Europe, Canada, and Japan.

我們將許可區域擴大到拉丁美洲，包括墨西哥以及中美洲、南美洲和加勒比海地區、中東和非洲的所有國家；除了我們原來的授權區域外，包括美國、歐洲、加拿大和日本。

We are excited to expand up our existing territories as we seek to bring ivonescimab to as many people around the globe as possible. In addition, I would like to take a moment to acknowledge that we strengthened our greater team recently with 2 new appointments to our Board of Directors.

我們很高興能夠擴大我們現有的領土，因為我們尋求將 ivonescimab 帶給全球盡可能多的人。此外，我想花一點時間承認，我們最近任命了兩名新的董事會成員，從而加強了我們的團隊。

In April 2024, renowned executive and genomicist, Dr. Mostafa Ronaghi joined our Board. He has played a leading role in the development of technology, which have helped improve the odds for patients with cancer, including biomarker-driven diagnostics, such as next-generation sequencing technology and platforms. He has cofounded several companies as well as being Illumina's Chief Technology Officer from 2008 to 2021.

2024 年 4 月，著名高階主管和基因組學家 Mostafa Ronaghi 博士加入我們的董事會。他在技術開發中發揮了主導作用，這些技術有助於提高癌症患者的患病幾率，包括生物標記驅動的診斷，例如下一代定序技術和平台。他共同創辦了多家公司，並於 2008 年至 2021 年間擔任 Illumina 的技術長。

In June, Mr. Jeff Huber, the transformational Google and GRAIL executive joined our Board as well. Prior to his current role leading Triatomic Capital, a VC firm, Jeff was the founding CEO and Vice Chairman of GRAIL, a mission-driven company seeking to detect cancer early when it can be cured. Prior to GRAIL, he was a Senior Vice President at Alphabet Inc., formerly known as Google inc.

6 月，變革型 Google 和 GRAIL 主管 Jeff Huber 先生也加入了我們的董事會。在擔任創投公司 Triatomic Capital 的現任領導職務之前，Jeff 是 GRAIL 的創始執行長兼副董事長，GRAIL 是一家以使命為導向的公司，致力於在癌症可以治癒的情況下及早發現癌症。在加入 GRAIL 之前，他曾擔任 Alphabet Inc.（前身為 Google Inc.）的高級副總裁。

Over 30 years at Google, he cofounded Google's life sciences effort in Google X and he led development and scaling of Google Maps, Google Apps such as Gmail, Google Calendar, Google Docs as well as Google Ads. Jeff managed a team of over 5,000 employees and 5 billion P&L during his time at Google.

在 Google 工作了 30 多年，他共同創立了 Google 的生命科學部門 Google X，並領導了 Google 地圖、Gmail、Google 日曆、Google Docs 等 Google Apps 以及 Google Ads 的開發和擴充。Jeff 在 Google 任職期間管理著一支由 5,000 多名員工組成的團隊和 50 億美元的損益。

In addition, Jeff is also a Board member at several other cutting edge companies. We are fortunate to have Mostafa and Jeff's perspectives and expertise as they join us in our mission to make a significant positive difference in the lives of patients with serious unmet medical need.

此外，傑夫也是其他幾家前沿公司的董事會成員。我們很幸運能夠擁有穆斯塔法和傑夫的觀點和專業知識，他們與我們一起履行我們的使命，為嚴重未滿足醫療需求的患者的生活帶來重大積極的改變。

Finally, I would like to take a moment to thank Team Summit, as Bob and I have described all of the accomplishments we have achieved over the past 1.5 years with ivonescimab. This team has done a remarkable job across every team in making our goals a reality. It is a tremendous honor and privilege to work with each member of Team Summit, and I would like to express my heartfelt thanks to each and every one of our great team members.

最後，我想花點時間感謝 Team Summit，因為 Bob 和我已經描述了我們在過去 1.5 年中利用 ivonescimab 取得的所有成就。在實現我們的目標方面，這個團隊在每個團隊中都做得非常出色。能夠與Team Summit的每位成員一起工作是一種巨大的榮幸和榮幸，我謹向我們每一位優秀的團隊成員表示衷心的感謝。

With that update, I will now ask Manmeet to provide details on our financial position and outlook. Manmeet?

更新後，我現在將要求 Manmeet 提供有關我們財務狀況和前景的詳細資訊。曼梅特？

Thank you, Maky, and good morning, everyone. We filed this morning our 10-Q for the second quarter of 2024. Today, I will provide you with an update on three items: our cash position after our recent $200 million financing; our updated cash runway guidance; and second quarter operating expenses.

謝謝你，麥基，大家早安。我們今天早上提交了 2024 年第二季的 10-Q 報告。今天，我將向您提供三項最新情況：我們最近融資 2 億美元後的現金狀況；我們更新的現金跑道指南；和第二季的營運費用。

Let me start with cash position. We ended the second quarter of 2024 with a cash position of $325.8 million. This cash position was strengthened at the end of second quarter with the closing of a $200 million unsolicited private placement from a single institutional investor in June 2024. This morning, we also filed a Form S-3 in order to register the shares, which were issued in the private placement on June 6, 2024.

讓我從現金狀況開始。截至 2024 年第二季末，我們的現金部位為 3.258 億美元。隨著 2024 年 6 月完成來自單一機構投資者的 2 億美元主動私募，第二季末這一現金狀況得到了加強。今天早上，我們也提交了 S-3 表格，以登記 2024 年 6 月 6 日私募發行的股票。

Moving to updated cash runway guidance. Based on our planned operations, including our two Phase 3 clinical trials, we updated our cash runway guidance and now expect that we have sufficient cash to run our operations into fourth quarter of 2025.

轉向更新的現金跑道指南。根據我們的計劃營運（包括兩項 3 期臨床試驗），我們更新了現金跑道指南，現在預計我們有足夠的現金將營運維持到 2025 年第四季。

Turning to operating expenses. I'll provide details to 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. Non-GAAP expenses exclude stock-based compensation and onetime charges related to acquired in-process R&D expenses.

轉向營運費用。我將提供 GAAP 和非 GAAP 數字的詳細資訊。您可以參閱我們今天早上發布的新聞稿，以了解 GAAP 與非 GAAP 財務指標的調整表。非公認會計原則費用不包括基於股票的薪酬和與收購的正在進行的研發費用相關的一次性費用。

Our GAAP R&D expenses during the second quarter were $30.8 million compared to $30.9 million for the first quarter of 2024. And non-GAAP R&D expenses were $27.3 million in the second quarter of 2024 compared to $28.5 million for the first quarter of 2024.

我們第二季的 GAAP 研發費用為 3,080 萬美元，而 2024 年第一季為 3,090 萬美元。2024 年第二季的非 GAAP 研發費用為 2,730 萬美元，而 2024 年第一季為 2,850 萬美元。

Our GAAP acquired IP R&D expenses during the second quarter were $15 million compared to 0 for the first quarter of 2024. This $15 million expense is related to our upfront consideration for adding territories of Latin America, Africa and Middle East as per the June 2024 license agreement amendment with Akeso.

我們第二季的 GAAP 收購智慧財產權研發費用為 1,500 萬美元，而 2024 年第一季為 0。這 1500 萬美元的費用與我們根據 2024 年 6 月與康方生物簽訂的許可協議修正案增加拉丁美洲、非洲和中東地區的前期考慮有關。

Turning to G&A. GAAP G&A expenses for our second quarter 2024 totaled to $14 million compared to $11.7 million for the first quarter of 2024. The -- and non-GAAP G&A expenses were $6.4 million during the second quarter of 2024 compared to $4.6 million for the first quarter of 2024. Overall, our non-GAAP operating expenses during second quarter 2024 were $33.7 million, consistent with $33.1 million for the first quarter of 2024.

轉向一般行政費用。2024 年第二季的 GAAP G&A 費用總計為 1,400 萬美元，而 2024 年第一季為 1,170 萬美元。2024 年第二季的 G&A 費用和非 GAAP 管理費用為 640 萬美元，而 2024 年第一季為 460 萬美元。整體而言，我們 2024 年第二季的非 GAAP 營運費用為 3,370 萬美元，與 2024 年第一季的 3,310 萬美元一致。

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

有了這個，我會把它交還給戴夫。

Thank you, Bob, Maky, and Manmeet. We'll now see if there are any questions that our team can help answer.

謝謝鮑勃、麥基和曼米特。現在我們將看看我們的團隊是否可以幫助回答任何問題。

Kristina, if you could please open the line for questions.

克里斯蒂娜，如果可以的話請打開提問熱線。

(Operator Instructions) Brad Canino, Stifel.

（操作員說明）Brad Canino，Stifel。

This is Dara Azar on for Brad. Could you be able to walk through the puts and takes of data disclosure? Is HARMONi-2 is at World Lung, when is it that title allowance or things like should we expect an abstract text before the presentation to have a lifted embargo? And if so, what data could be included in the abstract?

這是布拉德的達拉·阿扎爾。能詳細介紹一下資料揭露的過程嗎？HARMONi-2 是否在 World Lung，什麼時候我們應該在演示之前期待一個抽象文本解除禁運？如果是這樣，摘要中可以包含哪些資料？

Sure. Thanks, Dara. I appreciate the question. This is Dave responding. So as you can imagine, our HARMONi-2 data is considered a late-breaker abstract at the World Conference for Lung Cancer or World Lung.

當然。謝謝，達拉。我很欣賞這個問題。這是戴夫的回應。正如您可以想像的那樣，我們的 HARMONi-2 數據被認為是世界肺癌大會或世界肺病大會上的最新摘要。

So our partners at Akeso previously announced their intention to submit the HARMONi-2 data to the World Lung Conference. And so the deadline for abstracts for World Lung were July 31. Notifications to the primary authors of each of those abstracts that are late breakers are provided early in August, but generally between August 7 and August 10.

所以我們康方生物的合作夥伴之前就宣布有意向世界肺臟大會提交HARMONi-2數據。因此 World Lung 的摘要截止日期是 7 月 31 日。8 月初，我們會向遲到的摘要的主要作者發出通知，但通常是在 8 月 7 日至 8 月 10 日之間。

Traditionally, what my -- our understanding of what World Lung does is, around August 15, releases the titles and abstracts for most of the remaining -- so they've released some of the original titles already. But for the remaining titles and abstracts released around August 15.

傳統上，我的——我們對 World Lung 所做的事情的理解是，在 8 月 15 日左右，發布大部分剩餘的標題和摘要——所以他們已經發布了一些原始標題。但其餘標題和摘要則在 8 月 15 日左右發布。

However, what they do is they withhold a number of what they consider presidential symposium or otherwise larger presentations until the actual conference itself, at which point they only release title, but the abstract is held until the conference itself.

然而，他們所做的是，他們保留了一些他們認為的主席研討會或其他大型演講，直到實際會議本身，此時他們只發布標題，但摘要直到會議本身才舉行。

So at this point, because we haven't yet technically hit the acceptance time period of August 7 and August 10h, we're not yet made aware in terms of whether our abstract will be held back or not. So Dara, I appreciate the question. It's a very good question in terms of exactly the timeline of when things will come up.

因此，目前，由於技術上我們還沒有達到 8 月 7 日和 8 月 10 日的接受時間段，因此我們還不清楚我們的摘要是否會被保留。達拉，我很欣賞這個問題。就事情發生的確切時間表而言，這是一個非常好的問題。

But until we hit the approval date from World Lung between August 7 and August 10, and then they announce what they will and won't hold back until the conference itself, we'll need to wait patiently alongside you in terms of those details.

但是，直到我們在 8 月 7 日至 8 月 10 日之間達到 World Lung 的批准日期，然後他們宣佈在會議本身之前將保留和不會保留的內容之前，我們需要與您一起耐心等待這些細節。

Yes, very helpful overview. If I may ask a follow-up. What is your latest view on OS maturity? If it's going to be (inaudible) for inclusion in the presentation? If not, would there be any language in the abstract to describe the trend observed? And if there's time, I'll come back for another follow-up.

是的，非常有幫助的概述。如果我可以問後續情況。您對作業系統成熟度的最新看法是什麼？是否（聽不清楚）包含在簡報中？如果沒有，是否有任何抽象語言來描述觀察到的趨勢？如果有時間，我會回來進行另一次跟進。

Sure, Dara. So this is Dave again. I'll start and then I'll let Allen add any additional context that I'd like to. But if you recall from the earlier trials that were run with pembrolizumab is a monotherapy in the setting, the KEYNOTE-024 and the KEYNOTE-042 settings, there was the time period by which they reach their survival maturity. It was a little bit longer than the time period in which this trial has matured from last patient in.

當然，達拉。這又是戴夫。我將開始，然後讓艾倫添加我想要的任何其他上下文。但如果您還記得在 KEYNOTE-024 和 KEYNOTE-042 環境中使用派姆單抗作為單一療法進行的早期試驗，您會發現它們達到生存成熟期有一個時間段。這比該試驗從最後一名患者開始成熟的時間要長一些。

So as a reminder, HARMONi-2 completed enrollment around the end of the third quarter, beginning of the fourth quarter of 2023. And so as that interim analysis was run and, ultimately, the IDMC met and then we released the top line data along with our partners at Akeso in May.

提醒一下，HARMONi-2 在 2023 年第三季末、第四季初左右完成了註冊。因此，在進行中期分析後，最終 IDMC 召開了會議，然後我們與康方生物的合作夥伴在 5 月發布了頂線數據。

Not a lot of time from an overall survival had perspective transpired from when the trial completed enrollment. And so as a result, anything that we have at this point will be early. So we haven't made definitive announcements or decisions on exactly what will be presented with respect to overall survival.

從試驗完成入組開始，整體存活率並沒有太多時間改變。因此，我們目前所擁有的一切都將是早期的。因此，我們尚未就整體存活率的具體內容做出明確的公告或決定。

But what I would say is it's -- we're not holding anything back at this point as much as time needs to take place for these patients to remain on trial and study to get a mature enough readout for overall survival at a mature level?

但我想說的是，我們現在不會阻止任何事情，因為這些患者需要時間繼續進行試驗和研究，以獲得足夠成熟的讀數，以達到成熟水平的整體生存率？

Yes, not much to add, Dave, except that it is very early in this study. Remember, they just completed enrollment. This study hit its first primary or interim analysis very early. So the data were very immature at the time. And I think that bodes to the strength of the PFS data to date.

是的，戴夫，沒什麼好補充的，只是這項研究還處於早期階段。請記住，他們剛剛完成註冊。這項研究很早就進行了首次初步或中期分析。所以當時的數據非常不成熟。我認為這預示著迄今為止 PFS 數據的強度。

Yes. Makes a lot of sense. And the last two-parter, without OS, how do you think about what constitutes a good PFS result in isolation? And finally, how should we be thinking about additional Phase 3 plans, perhaps announcement in relation to HARMONi-2 medical meeting update. That's it from me.

是的。很有道理。最後兩部分，在沒有作業系統的情況下，您如何看待孤立地看什麼構成良好的 PFS 結果？最後，我們應該如何考慮額外的第 3 階段計劃，也許是與 HARMONi-2 醫學會議更新相關的公告。這就是我說的。

Yes. So I'll take the first question. In terms of the PFS, we're not going to comment on that. You'll have to come see us at that meeting, and then you'll see the results there. And I understand why everybody is interested in that, we're just not going to disclose it at this time.

是的。那我來回答第一個問題。就 PFS 而言，我們不會對此發表評論。你必須來參加我們的會議，然後你就會在那裡看到結果。我理解為什麼每個人都對此感興趣，只是我們現在不打算透露。

In terms of additional Phase 3 programs, we probably will make announcements at World Lung, but you'll see some data maturing in lungs and some other lung indications as well. And the development plan that will be fairly obvious in terms of recreating sort of key studies that Merck or AstraZeneca has done in the past, and we'll probably prioritize based on unmet need.

就其他第三階段計劃而言，我們可能會在世界肺臟大會上宣布，但您會看到一些肺部數據和其他一些肺部適應症的成熟數據。就重新創建默克或阿斯特捷利康過去所做的關鍵研究而言，開發計劃將相當明顯，我們可能會根據未滿足的需求確定優先順序。

Yigal Nochomovitz, Citigroup.

伊格爾·諾霍莫維茨，花旗集團。

Yigal Nochomovitz^ Obviously, a very key one for investors, and I've received a lot of questions on is the read-through from HARMONi-2 to HARMONi-3. So I'm curious, given the apparent strength of the PFS data in HARMONi-2, could you comment as to how you're thinking about the addition of the chemo backbone in terms of extracting the relative benefit of ivonescimab over KEYTRUDA in squamous in HARMONi-3? And I have a few follow-ups.

Yigal Nochomovitz^ 顯然，這對投資者來說非常關鍵，我收到了很多關於從 HARMONi-2 到 HARMONi-3 的通讀問題。因此，我很好奇，考慮到 HARMONi-2 中 PFS 數據的明顯強度，您能否評論一下您如何考慮添加化療骨幹，以提取 ivonescimab 相對於 KEYTRUDA 在鱗狀細胞癌中的相對益處？ 3？我還有一些後續行動。

Yes, Yigal, thanks for the question. So we're very confident for HARMONi-3. I think the strength of the HARMONi-2 data has given us more confidence. I mean remember, we decided to do HARMONi-3 before the HARMONi-2 data were available. So we thought that squamous was an unmet need.

是的，伊格爾，謝謝你的提問。所以我們對HARMONi-3非常有信心。我認為HARMONi-2數據的實力給了我們更多的信心。我的意思是記住，我們決定在 HARMONi-2 資料可用之前進行 HARMONi-3。所以我們認為鱗狀細胞的需求尚未被滿足。

We thought that VEGF-targeted agents were never developed in squam because of safety concerns. We did not see those safety concerns in the development by ivonescimab, and that's why we thought HARMONi-3 was low-hanging fruit for ivonescimab.

我們認為出於安全考慮，VEGF 標靶藥物從未在鱗狀細胞中開發出來。我們在 ivonescimab 的開發過程中沒有看到這些安全問題，這就是為什麼我們認為 HARMONi-3 是 ivonescimab 容易實現的目標。

Given the strength of the HARMONi-2 data, we're even more confident. The addition of chemotherapy may change things in terms of reduction of tumors, but I don't think it will change biologically the importance of ivonescimab for this population. And then the second question was on...

考慮到 HARMONi-2 數據的強度，我們更有信心。添加化療可能會改變腫瘤減少的情況，但我認為這不會從生物學角度改變 ivonescimab 對該族群的重要性。然後第二個問題是關於...

Sorry, Yigal, could you repeat your second question?

抱歉，Yigal，您能重複您的第二個問題嗎？

I didn't ask it yet. The second one was just to confirm, so for HARMONi-2, it's TPS greater than 1%. For HARMONi-3, is it all TPS scores? And does that make any notable difference in your mind or not really?

我還沒問。第二個只是為了確認，所以對於HARMONi-2來說，它的TPS大於1%。對HARMONi-3來說，都是TPS分數嗎？這對你的想法是否有任何顯著的影響？

Yes. It's for all TPS scores, and it did. Going into this study in terms of the HARMONi-3 before we had the HARMONi-2 results, I was actually more confident in the lower TPS expressing or the lower PD-L1-expressing patients because of the VEGF component. But looking at the HARMONi-2 data, as we said publicly, we seem to see a benefit across PD-L1 expression levels. So we don't think it matters what patients will come on to the study.

是的。它適用於所有 TPS 分數，而且確實如此。在獲得 HARMONi-2 結果之前，根據 HARMONi-3 進行這項研究，由於 VEGF 成分，我實際上對 TPS 表達較低或 PD-L1 表達較低的患者更有信心。但正如我們公開所說，從 HARMONi-2 數據來看，我們似乎看到了 PD-L1 表達水平的優勢。因此，我們認為哪些患者參加研究並不重要。

Okay. Another key question in terms of the catalyst path for the company is potential interim readouts for HARMONi-3. And I understand they are built into the protocol. Could you comment at all as to what might be in store as far as potential interim readouts for HARMONi-3 over the next several quarters?

好的。該公司催化劑路徑的另一個關鍵問題是 HARMONi-3 的潛在中期讀數。我知道它們已內建在協議中。您能否對未來幾季 HARMONi-3 的潛在中期讀數發表評論？

Yes, Yigal. That's a great question, and we can't really disclose that and we haven't disclosed that at this time. I will say that our Akeso partners are running a parallel study called the 306 study, which is actually in the similar population, which is ivonescimab against tislelizumab, which is the standard of care in China. So those results won't be out earlier as well, but we haven't disclosed nor as our Akeso partner disclosed any timelines around that.

是的，伊格爾。這是一個很好的問題，我們無法真正透露這一點，而且目前我們還沒有透露這一點。我要說的是，我們康方生物的合作夥伴正在進行一項名為306研究的平行研究，該研究實際上是在相似的人群中，即ivonescimab與tislelizumab的對比，這是中國的護理標準。因此，這些結果也不會更早公佈，但我們尚未披露，也沒有像我們的康方合作夥伴那樣披露任何相關時間表。

Okay. And then the last question is, I think, Maky mentioned that there were some abstract titles for some of these other solid tumors in the Phase 2 triple-negative breast, colorectal, head and neck. But then you also are starting the MD Anderson partnership. So can you just kind of comment on how those two work streams are going to intersect between your own Phase 2 work as well as what MD Anderson is doing with respect to tumors outside of lung?

好的。最後一個問題是，我認為，Maky 提到，二期三陰性乳癌、大腸癌、頭頸癌中的一些其他實體瘤有一些抽象標題。但隨後您也將開始與 MD 安德森合作夥伴關係。那麼，您能否評論一下這兩個工作流程將如何在您自己的第二階段工作之間交叉，以及 MD 安德森在肺外腫瘤方面所做的工作？

Yigal, thanks for the question. Yes, so first of all, the MD Anderson collaboration is very exciting. Speaking with physicians and experts at MD Anderson gives us access to a treasure trove of scientific and clinical expertise. I think if you look at the way the two programs interact, remember Akeso was doing the lion's share of the Phase 2 work, and they've done quite a lot of Phase 2 work.

伊格爾，謝謝你的提問。是的，首先，與 MD 安德森的合作非常令人興奮。與 MD 安德森的醫生和專家交談使我們能夠獲得科學和臨床專業知識的寶庫。我想如果你看看這兩個程式互動的方式，請記住康方生物正在做第二階段的大部分工作，而且他們已經做了相當多的第二階段工作。

However, there might be some minor gaps in the sense that the standard of care in China is different or certain tumor types are not as prevalent in China. And this is where MD Anderson can help us get quick signals, some Phase 2 data as well.

然而，由於中國的護理標準不同或某些腫瘤類型在中國並不普遍，因此可能存在一些細微的差距。這就是 MD 安德森癌症中心可以幫助我們快速獲取訊號以及一些第二階段數據的地方。

And then again, the scientific expertise. So when we have a question around a certain tumor type or certain subsets of tumor types that they're not interested in China, this is where the gap will be filled with MD Anderson without specific questions. Do you have specific questions on specific tumor types?

再說一遍，科學專業知識。因此，當我們對某種腫瘤類型或某些腫瘤類型子集有疑問而他們對中國不感興趣時，MD安德森將在沒有具體問題的情況下填補這一空白。您對特定腫瘤類型有具體問題嗎？

No, not at this point, but that's helpful.

不，目前還不行，但這很有幫助。

Mitchell Kapoor, H.C. Wainwright.

米切爾·卡普爾，H.C.溫賴特。

Congrats on the recent data. The first question I have here is just given the fact that most of the 420 HARMONi patients will be bundled from HARMONi-A. Could you potentially envision something similar for leveraging the HARMONi-2 data in the US?

恭喜最近的數據。我在這裡提出的第一個問題是，420 名 HARMONi 患者中的大多數將與 HARMONi-A 捆綁在一起。您能否設想利用美國的 HARMONi-2 數據進行類似的事情？

Possibly. And so we're in the midst of sort of discussions with the agency. It's clear that we won't be able to file on the HARMONi-2 data in all regions. And so that's something that we're going to try to address. However, there is an opportunity to leverage the HARMONi-2 data in future studies as well without disclosing more than that.

可能吧。因此，我們正在與該機構進行某種討論。很明顯，我們無法在所有地區歸檔 HARMONi-2 資料。這就是我們要努力解決的問題。然而，在未來的研究中也有機會利用 HARMONi-2 數據，而無需透露更多資訊。

Okay. Great. And then just broadly on the use of ivonescimab in lower PD-L1 TPS scores, thinking like closer to 1 versus the 49 range, is there a threshold where ivonescimab becomes more clearly effective?

好的。偉大的。然後，廣義地講，在較低的 PD-L1 TPS 分數中使用 ivonescimab，考慮接近 1 與 49 範圍，是否存在一個閾值，使 ivonescimab 變得更加明顯有效？

Yes. Well, so I think the best data results are from the 201 and the 202 study, the Phase 2 data. And you see a clear trend where the response rate does increase as PD-L1 expression increases. And in the opposite direction, as PD-L1 expression decreases, the level activity drops off, but not as sharply as other PD-1 or PD-L1 agents.

是的。嗯，所以我認為最好的數據結果來自 201 和 202 研究，即第二階段數據。您會看到一個明顯的趨勢，即反應率確實隨著 PD-L1 表達的增加而增加。相反，隨著 PD-L1 表現的減少，活性水平也會下降，但不像其他 PD-1 或​​ PD-L1 藥物那樣急劇下降。

So I think this is probably the VEGF effect. And there are other bispecific immunotherapies out there like PD-1 CTLA-4 that are looking at the PD-1 negatives.

所以我認為這可能是VEGF效應。還有其他雙特異性免疫療法，例如針對 PD-1 陰性的 PD-1 CTLA-4。

So the question is, how good will we be there, and I think we'll be pretty strong there as well. So I get the question, we see the benefit across the whole spectrum. The benefit seems to be greater in the high PD-1 and relative to PD-1s, where is that relative benefit. The relative benefit is actually greater, even though the overall response rate is a little bit lower in the low PD-L1 expression. I know it's kind of confusing.

所以問題是，我們在那裡會有多好，我認為我們在那裡也會非常強大。所以我明白了這個問題，我們看到了整個範圍內的好處。高 PD-1 的益處似乎比 PD-1 更大，相對益處在哪裡。儘管低 PD-L1 表現的整體緩解率稍低，但相對效益實際上更大。我知道這有點令人困惑。

But again, I think we see good activity across all PD-L1 expressions. There's a slight increase for ivonescimab for the PD-1s high-expressing, PD-L1 high expressing as well.

但我再次認為，我們在所有 PD-L1 表現中都看到了良好的活性。對於高表達的 PD-1 和高表達的 PD-L1，ivonescimab 略有增加。

As a reference point, this is Dave, Mitchell, that you can go back to is the ASCO 2023 poster, which actually kind of lays out bi-PD-L1 expression status in the Phase 2 trials, as Allen mentioned, especially in combination with chemo, the relative benefit in the bi-PD-L1 expression.

作為參考點，這是 Dave、Mitchell，您可以回顧一下 ASCO 2023 海報，它實際上列出了第二階段試驗中的雙 PD-L1 表達狀態，正如 Allen 提到的，特別是與化療對bi- PD-L1 表現的相對益處。

(Operator Instructions) With no further questions, Dave, I'll turn the floor back over to you.

（操作員說明）戴夫，沒有其他問題了，我將把發言權交還給你。

Thank you very much. We appreciate everyone taking the time to join us this morning for our quarterly earnings call. We appreciate your continued support, and we wish you a great day. Thank you very much.

非常感謝。我們感謝大家今天早上抽出時間參加我們的季度財報電話會議。我們感謝您一如既往的支持，祝您有個愉快的一天。非常感謝。

Thank you. Once again, this does conclude today's conference call. You may now disconnect. Have a great day.

謝謝。今天的電話會議再次結束。您現在可以斷開連線。祝你有美好的一天。