Summit Therapeutics Inc (SMMT) 2025 Q1 法說會逐字稿

Thank you for standing by. Hello and welcome to the Summit Therapeutics Q1 2025 earns conference call. I would now like to turn the call over to our chief business and strategy officer; Dave Gancarz. Please go ahead, sir.

感謝您的支持。您好，歡迎參加 Summit Therapeutics 2025 年第一季財報電話會議。現在我想把電話轉給我們的首席業務和策略長；戴夫·甘卡茲。先生，請繼續。

Good afternoon and thank you for joining us. A press release was issued earlier this afternoon and is available on the home page of our website. Our Form 10 was also filed 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.

下午好，感謝您加入我們。今天下午早些時候發布了一份新聞稿，可在我們網站的主頁上查閱。我們的表格 10 也已提交，可在我們的網站上查閱。今天的電話會議將同時進行網路直播，存檔重播也將在今天稍後在我們的網站 www.smmttx.com 上提供。

Joining me on the call today is Bob Duggan, our Chairman of the board and 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. Allen S. Yang, our Chief Medical Officer, and Dr. Jack West; Vice President and our thoracic oncology TA head. Before we get started with the rest of the call, I would like to note that some of the 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.

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鮑勃·杜根 (Bob Duggan)；我們的聯合首席執行官兼總裁 Maky Zanganeh 博士、我們的首席營運官兼首席財務官 Manmeet Soni、我們的首席醫療官 Allen S. Yang 博士和 Jack West 博士；副總裁兼我們的胸腔腫瘤科助教主任。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. Following comments from Bob McKee and Man, we will take questions. With that, I would like to turn the call over to Bob.

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，請參閱我們的美國證券交易委員會 (SEC) 文件。除法律要求外，Summit 不承擔更新這些前瞻性聲明的義務。在聽完 Bob McKee 和 Man 的評論後，我們將回答問題。說完這些，我想把電話轉給鮑伯。

Thank you, Dave. Good afternoon, everyone, and thank you for joining us today. As you can imagine, I'm very proud of, as well as encouraged by the ongoing accomplishments of Team Summit and the continuing positive information and enthusiasm surrounding ivonescimab, our lead medicinal investigational asset.

謝謝你，戴夫。大家下午好，感謝大家今天的參與。你可以想像，我對 Team Summit 的持續成就以及圍繞我們的主要藥物研究資產 ivonescimab 的持續積極信息和熱情感到非常自豪和鼓舞。

We have begun in 2025 with excellent progress and continue to take meaningful steps in the development of ivonescimab. We continue to advance our mission of building a viable organization, making a significant positive difference in serious unmet medical needs. Specifically, last week, our partner Akeso made two important, as well as material announcements.

我們在 2025 年取得了優異的進展，並繼續在 ivonescimab 的開發中邁出有意義的步伐。我們將繼續推動我們的使命，即建立一個可行的組織，為解決嚴重的未滿足的醫療需求做出重大的積極貢獻。具體來說，上週我們的合作夥伴康方生物發布了兩項重要且重大的公告。

First, ivonescimab received approval from NMPA, the health authority in China, as frontline monotherapy treatment for patients with NSCLC, whose tumors have positive. PDL one expression. This marks an important regulatory milestone for our partners at Akeso and adds to the growing evidence of ivonescimab differentiated profile and its potential to make a significant difference in the lives of patients dealing with hard to treat cancers.

首先，ivonescimab 獲得了中國衛生主管部門 NMPA 的批准，作為治療腫瘤呈陽性的 NSCLC 患者的一線單藥治療。PDL 一個表達式。這對我們在康方生物的合作夥伴來說是一個重要的監管里程碑，也進一步證明了 ivonescimab 的差異化特性及其為治療難治性癌症患者的生活帶來重大改變的潛力。

On behalf of the summit team, we want to extend our congratulations to our partners at Akeso for this achievement and our gratitude for our strong ongoing partnership. This approval was based on positive PFS results from the Akeso's Harmony II trial, which was disclosed at last year's World Conference on Lung Cancer. Additionally, to supplement this groundbreaking PFS data that represented the first drug to achieve a statistically significant benefit over pembrolizumab in a phase three clinical trial, the NMPA requested that Akeso perform an interim analysis of overall survival.

我謹代表峰會團隊，向康方生物的合作夥伴所取得的成就表示祝賀，並對我們持續的強大合作關係表示感謝。這項批准基於康方生物的 Harmony II 試驗的積極 PFS 結果，該結果在去年的世界肺癌大會上披露。此外，為了補充這項突破性的 PFS 數據（該數據代表了第一個在 III 期臨床試驗中取得優於帕博利珠單抗的統計學顯著優勢的藥物），NMPA 要求康方生物進行總生存期的中期分析。

Last week Akeso reported on the health authority requested early interim analysis. The analysis showed a clinically meaningful and strongly positive trend favoring ivonescimab at 39% data maturity with a hazard ratio. Of 0.777 implying a potential 22% reduction in the risk of death compared to Pembroke. To be clear, at Summit, we are pleased and excited about this remarkable outcome. McKee will discuss this a little further in a few moments.

上週，康方生物通報了衛生部門要求進行早期中期分析的情況。分析顯示，ivonescimab 具有臨床意義和強烈的正面趨勢，數據成熟度為 39%，風險比為。0.777 意味著與彭布羅克相比死亡風險可能降低 22%。需要明確的是，在高峰會上，我們對這項非凡的成果感到高興和興奮。麥基稍後將進一步討論這個問題。

Additionally, the Akeso's Harmony sixth Phase three clinical trial met its primary endpoint of progression pre-survival at a pre-specified interim analysis conducted by an independent data monitoring committee. This trial evaluated ivonescimab in combination with chemotherapy against cilizumab, a PD one inhibitor in combination with chemotherapy in patients with advanced squamous non-small cell lung cancer, regardless of PDL one expression. Conducted in China by our partners at the Kesso, the trial showed statistically significant and clinically meaningful improvement in progression free survival for ivonescimab plus chemotherapy.

此外，康方生物的 Harmony 第六期三期臨床試驗在獨立數據監測委員會進行的預先指定的中期分析中達到了生存前進展的主要終點。該試驗評估了 ivonescimab 與化療聯合使用對晚期鱗狀非小細胞肺癌患者（無論 PDL-1 表達如何）的療效，以及 cilizumab（一種 PD-1 抑制劑）與化療聯合使用的效果。該試驗由我們在 Kesso 的合作夥伴在中國進行，結果顯示，ivonescimab 聯合化療在無進展生存期方面有統計學和臨床意義的改善。

Akeso noted that no new safety signals were identified. This marks the first known phase three trial in NSCLC to show significant improvement over a PD1 or PDL1 inhibitor combined with chemotherapy in a head to head setting. Following the success of the Akeso's Harmony II study, this is the second instance where ivonescimab based regimens have demonstrated significant benefits in frontline treatment in non-small cell lung cancer. The full data set for Harmony six is planned to be presented at an upcoming major medical conference later this year.

康方生物指出，未發現新的安全訊號。這是已知的首個 NSCLC 三期臨床試驗，在頭對頭試驗中顯示 PD1 或 PDL1 抑制劑與化療聯合使用有顯著改善。繼康方生物的 Harmony II 研究取得成功之後，這是第二次基於 ivonescimab 的方案在非小細胞肺癌一線治療中顯示出顯著益處。Harmony Six 的完整數據集計劃於今年稍後在即將舉行的大型醫學會議上公佈。

Turning to our own global phase three trials, we expect top line data in mid 2025 from Harmony, our global phase three trial in patients with EGFR mutated advanced non-small cell lung cancer who have progressed after treatment with a third generation EGFR thyrosine kinase inhibitor. As a reminder, Harmony is Summit's first global registrational phase three trial and received fast track designation from the US FDA.

談到我們自己的全球第三階段試驗，我們預計在 2025 年中期從 Harmony 獲得頂線數據，這是我們針對 EGFR 突變晚期非小細胞肺癌患者進行的全球第三階段試驗，這些患者在接受第三代 EGFR 甲狀腺氨酸激酶抑製劑治療後病情出現進展。提醒一下，Harmony 是 Summit 的首個全球註冊第三階段試驗，並獲得了美國 FDA 的快速通道資格。

We're also excited to see progress in the expansion of ivonescimab studies through collaborations with leading organizations for which McKee will provide additional data. We will provide details. In the future, on additional catalysts, including top line results from our first registration of phase three harmony trial and our clinical development plans beyond non-small cell lung cancer, both of which will be provided later in 2025. McKee will further discuss these accomplishments, driving our strong, unyielding belief in what can be accomplished by Team Summit and our conviction and the potential of ivonescimab.

我們也很高興看到透過與領先組織的合作，ivonescimab 研究的擴展取得了進展，McKee 將為此提供更多數據。我們將提供詳細資訊。未來，我們將考慮其他催化劑，包括我們首次註冊的第三階段和諧試驗的頂線結果以及非小細胞肺癌以外的臨床開發計劃，這兩項都將在 2025 年晚些時候提供。McKee 將進一步討論這些成就，推動我們對 Team Summit 所能取得的成就的堅定信念以及我們對 ivonescimab 的信念和潛力。

We are a mission and purpose-driven organization with a collective goal to improve quality of life, increase potential duration of life, and resolve serious medical needs. We believe we have the right team and the right molecule and ivonescimab to realize this goal. Not only do we have the right team, we have the right partner.

我們是一個以使命和目標為導向的組織，我們的共同目標是改善生活品質、延長潛在壽命並解決嚴重的醫療需求。我們相信我們擁有合適的團隊、合適的分子和 ivonescimab 來實現這一目標。我們不僅擁有合適的團隊，還擁有合適的合作夥伴。

The courage displayed by Michelle Shah and the Akeso team to conduct a head to head study against Pembroke was rewarded by the results and well deserved second approval for ivonescimab in China. However, it also served to raise the awareness of ivonescimab globally when Ivo became the first drug to demonstrate an improvement head to head in a phase three trial versus Pembroke.

Michelle Shah 和康方生物團隊展現出的勇氣，與 Pembroke 進行了一對一的研究，結果給予了他們回報，並且當之無愧地獲得了 ivonescimab 在中國的第二次批准。然而，當 Ivo 成為第一個在第三階段試驗中與 Pembroke 正面交鋒並顯示出改善的藥物時，它也提高了全球對 ivonescimab 的認識。

Blockbuster drug development takes courage, and Akeso has demonstrated this courage on more than a few occasions, unlike many companies that have tried to. It failed. With that, I will turn the call over to McKee for additional context and recent highlights for your consideration. Maky, you ready to jump in?

開發重磅藥物需要勇氣，與許多嘗試過的公司不同，康方生物已多次展現出這種勇氣。失敗了。接下來，我將把電話轉給麥基，以獲得更多背景資訊和近期亮點供您考慮。Maky，你準備好了嗎？

Yes, thank you, Bob, and good afternoon, everyone. As Bob said, I remain incredibly enthusiastic about the future of summit and the possibilities of what can be accomplished with our lead candidate ivonescimab, especially as we approach our first global phase three readout and begin to grow our commercial team.

是的，謝謝你，鮑勃，大家下午好。正如鮑勃所說，我仍然對 Summit 的未來以及我們的主要候選藥物 ivonescimab 所能取得的成就充滿熱情，特別是當我們接近我們的第一個全球第三階段讀數並開始擴大我們的商業團隊時。

Before providing some additional detail and reviewing the current pipeline, I would like to highlight our current progress in developing ivonescimab and dive a bit deeper on a few concepts that Bob touched on. Since 2019, more than 2,300 patients have been treated in clinical trials with ivonescimab. Currently combined between our partners at Akeso and our team at Summit.

在提供更多細節和回顧當前研發線之前，我想先強調一下我們目前在開發 ivonescimab 方面的進展，並更深入地探討 Bob 提到的一些概念。自 2019 年以來，已有超過 2,300 名患者接受了 ivonescimab 的臨床試驗治療。目前由康方生物的合夥人和 Summit 的團隊共同組成。

four phase three trials have completed enrollment, three of which have had top line data read out, and the other, the summit sponsored harmony trial, we expect topline data in the middle of this year.

四個第三階段試驗已經完成招募，其中三個已經讀出了頂線數據，另一個是由 Summit 贊助的 Harmony 試驗，我們預計今年年中可以獲得頂線數據。

five phase three trials are currently ongoing. two of these are summit sponsored trials in first line non-sponsored lung cancer, and three are Akeso sponsored trials studying ivonescimab in head and neck, biliary tract, and triple negative breast cancers.

目前正在進行五項第三階段試驗。其中兩項是 Summit 贊助的一線非贊助肺癌試驗，三項是康方生物贊助的研究 ivonescimab 在頭頸部癌、膽道癌和三陰性乳腺癌的試驗。

Akeso has also announced its intention to conduct phase 3 clinical trials in pancreatic cancer, as well as immunotherapy, refractory, non-small cell lung cancer patients. With the addition of these trials, the cumulative number of phase three trials for ivonescimab that have been announced or ongoing or have completed is now 11.

康方生物也宣布有意進行胰臟癌以及免疫治療、難治性非小細胞肺癌患者的 3 期臨床試驗。隨著這些試驗的加入，ivonescimab 已宣布、正在進行或已完成的第三期試驗累積數量現已達到 11 項。

On top of this, a significant amount of relevant data is being generated in additional indications, including colorectal cancer, ovarian cancer, gastric cancer, and hepatocellular carcinoma to further support our broad platform cancer program. Turning specifically to the summit-sponsored pipeline. Our first global phase three trial harmony is evaluating ivonescimab in patients with EGFR mutant non-small cell lung cancer after progressing on a third generation TKI such as (aimertinib).

除此之外，我們還在結直腸癌、卵巢癌、胃癌和肝細胞癌等其他適應症中產生了大量相關數據，以進一步支持我們廣泛的平台癌症計劃。具體談談峰會贊助的管道。我們的第一個全球 III 期臨床試驗正在評估 Ivonescimab 對 EGFR 突變型非小細胞肺癌患者在接受第三代 TKI 治療後出現進展的情況，例如（艾美替尼）。

While this is a limited market opportunity compared to frontline treatment for non-small cell lung cancer, harmony represents our initial fast to market strategy with ivonescimab. Historically, PD one inhibitors, including Pembro have tried and failed to demonstrate a benefit in PFS or OS in the EGFR metano small cell lung cancer setting. This provides the ivonescimab the opportunity to differentiate itself from current PD1 therapies as well as a novel mechanic and a new treatment option for patients.

雖然與非小細胞肺癌的第一線治療相比，這是一個有限的市場機會，但和諧代表了我們採用 ivonescimab 的初步快速上市策略。從歷史上看，包括 Pembro 在內的 PD 抑制劑曾嘗試證明其在 EGFR 轉移性小細胞肺癌環境中對 PFS 或 OS 有益，但未能成功。這為 ivonescimab 提供了與目前 PD1 療法區分開來的機會，同時也為患者提供了一種新的機制和新的治療選擇。

The enrollment for the harmony trial completed in October of last year and topline data is expected mid 2025. This data is expected to contain data associated with both primary endpoints, progression free survival, and overall survival. Subsequently, we started two additional global phase three studies, harmony three and harmony seven, which both evaluate ivonescimab head to head versus Pembro, either with or without chemotherapy in front line, non-small cell lung cancer. Harmony, evaluate ivonescimab in combination with chemotherapy and hormony seven, evaluate abanisimab as monotherapy.

和諧試驗的招募已於去年 10 月完成，預計 2025 年中期將獲得頂線數據。預計該數據將包含與主要終點、無惡化存活期和整體存活期相關的數據。隨後，我們啟動了另外兩項全球第三階段研究，即 Harmony Three 和 Harmony Seven，這兩項研究均評估了 Ivonescimab 與 Pembro 在一線非小細胞肺癌治療中聯合或不聯合化療的療效。Harmony，評估ivonescimab與化療和hormony seven的合併治療效果，評估abanisimab作為單一療法的療效。

Last October, Harmony tree was amended by significantly expanding the addressable patient population to include all frontline metastatic non-small cell lung cancer patients without driver mutations by including patients with non-squamous tumors in addition to squamous tumors. With this amendment, Harmony three is now an all commerce study from a histology perspective and a PDL one expression perspective in frontline non-small cell lung cancer, covering an addressable patient population two to three times larger than prior to the amendment.

去年 10 月，Harmony 樹進行了修訂，透過大幅擴大可尋址患者群體，除了鱗狀腫瘤患者外，還納入了非鱗狀腫瘤患者，將所有沒有驅動突變的一線轉移性非小細胞肺癌患者納入其中。透過此項修訂，Harmony Three 現已成為一項從組織學角度和 PDL 一表達角度針對一線非小細胞肺癌進行的全商業研究，覆蓋的可尋址患者群體比修訂前大兩到三倍。

As a reminder, this trial enrolls patients irrespective of PDL-1 expression, including those patients whose tumors do not express PDL-1. Additionally, we have now begun enrolling patients in Harmony seven as we continue to activate clinical trial sites in the United States and will expand beyond the US in the coming months. Later this year, we expect to announce additional details expanding our clinical development plan around the ivonescimab, including beyond lung cancer.

提醒一下，本試驗招募的患者不考慮 PDL-1 的表達，包括腫瘤不表達 PDL-1 的患者。此外，我們現在已經開始招募 Harmony Seven 的患者，同時我們將繼續在美國啟動臨床試驗地點，並將在未來幾個月內擴展到美國以外。今年晚些時候，我們預計將公佈更多細節，擴大我們圍繞 ivonescimab 的臨床開發計劃，包括肺癌以外的領域。

We continue to receive strong interest for investigator sponsored trials, including in the most recent open window which closed just two weeks ago. To date we have approved over 30 ISDs with a review of meaningful submissions from the last window to be performed shortly. These collaborations enhance our sponsored clinical development activities and can show signals in settings where ivonescimab has not yet been explored.

我們繼續收到對研究者發起的試驗的強烈興趣，包括兩週前剛關閉的最新開放窗口。到目前為止，我們已經批准了 30 多個 ISD，並將很快對上一個視窗期內提交的有意義的內容進行審查。這些合作增強了我們贊助的臨床開發活動，並且可以在尚未探索 ivonescimab 的環境中顯示出訊號。

Our strategic collaboration with MD Anderson, which commenced in July 2024, now has two studies that are activated and are enrolling in Houston with either cutaneous squamous cell carcinoma or glioblastoma. We committed 15 million to this collaboration to quickly discover additional opportunities for ivonescimab, including several tumor settings outside of this current development plan, as well as the possibility of identifying biomarkers through additional research activities.

我們與 MD Anderson 的策略合作於 2024 年 7 月開始，目前已有兩項研究在休士頓啟動並招募患者，研究對象為皮膚鱗狀細胞癌或膠質母細胞瘤。我們為此合作投入了 1500 萬美元，以快速發現 ivonescimab 的更多機會，包括當前開發計劃之外的幾種腫瘤環境，以及透過額外的研究活動識別生物標誌物的可能性。

Separately, we continue to support investigator sponsored trials, or ISDs, two of which have begun enrolling at the Memorial Sloan Kettering Cancer Center and then a Farber Cancer Institute.

另外，我們繼續支持研究者發起的試驗（ISD），其中兩項試驗已開始在紀念斯隆凱特琳癌症中心和法伯癌症研究所招募。

We are also looking forward to the initiation of clinical trials as part of our collaboration with Pfizer, which are expected later this year. This collaboration allows us to quickly advance beyond our current promising late stage development plan to evaluate ivonescimab in combination with some of the most innovative ADCs from Pfizer. Pfizer will be responsible for the operations and costs associated with these trials. Summit will provide ivonescimab, and both parties will jointly oversee the studies.

我們也期待與輝瑞合作的臨床試驗的啟動，預計今年稍後進行。此次合作使我們能夠快速推進目前有前景的後期開發計劃，以評估 ivonescimab 與輝瑞一些最具創新性的 ADC 的結合效果。輝瑞公司將負責這些試驗的相關營運和費用。Summit 將提供 ivonescimab，雙方將共同監督研究。

As you recall, ivonescimab brings two highly validated targets together into one novel by a specific antibody that targets both PD1 and (Vja) and holds a meaningful lead in terms of time and data generation in the clinical development of this novel class of compounds.

您還記得，ivonescimab 透過一種針對 PD1 和（Vja）的特定抗體將兩個經過高度驗證的靶點整合成一個新的靶點，並在該類新型化合物的臨床開發中在時間和數據生成方面佔據了領先地位。

Next, I would like to review some of the catalysts that we previously announced for this year. As we touched on a moment ago, we are anticipating harmony topline data in mid 2025, which we expect will include data related to both primary end points of progression free survival and overall survival.

接下來，我想回顧一下我們之前宣布的今年的一些催化劑。正如我們剛才提到的，我們預計在 2025 年中期將獲得和諧的頂線數據，我們預計其中將包括與無進展生存期和總體生存期這兩個主要終點相關的數據。

This will be the first global phase three clinical trial readout for ivonescimab which will provide information related to clinical profile of ivonescimab beyond China, as well as data that may lead to a potential path to applying for marketing authorization in our territories, including the United States, as we stated previously. This trial was conducted with patients whose non-small cell lung cancer was positive for EGFR mutations and had progressed after third generation TKI therapy.

這將是 ivonescimab 的首次全球三期臨床試驗讀數，它將提供與中國以外的 ivonescimab 臨床概況相關的信息，以及可能導致在我們的領土（包括美國）申請營銷授權的潛在途徑的數據，正如我們之前所說的。此試驗針對的是EGFR突變呈陽性且在第三代TKI治療後病情出現進展的非小細胞肺癌患者進行。

This is a setting where PD1 inhibitors, including Pembro had failed to show an improvement in either progression to survival or overall survival, providing an opportunity to demonstrate the differentiated mechanism of action for ivonescimab beyond currently available immunotherapy options. As a reminder the study contains a subset of patients from the Harmony A study conducted by Akeso in China, who received a third generation EGFRTKI. Harmony A led the first approval and commercial launch of ivonescimab in China in patients with EGFR mittens non-small cell lung cancer.

在這種情況下，包括 Pembro 在內的 PD1 抑制劑未能顯示生存進展或整體存活的改善，這為展示 ivonescimab 超越目前可用的免疫療法選擇的差異化作用機制提供了機會。提醒一下，研究包含來自中國康方生物進行的 Harmony A 研究的一部分患者，他們接受了第三代 EGFRTKI 治療。Harmony A 主導中國首次批准並商業化推出ivonescimab，用於治療EGFR突變非小細胞肺癌患者。

Additionally, harmony sex as a catalyst event is intended to answer a proposed question as to whether the PFS benefits seen with ivonescimab monotherapy compared to PD 1 monotherapy would carry over to chemo combination settings in this case in frontline non small cell lung cancer. As was announced last week in harmony six ivonescimab in combination with chemotherapy, achieved statistically, clinically meaningful PFS benefit over (Tlazimab) in combination with chemotherapy in frontline patients with squamous non-small cell lung cancer patients.

此外，和諧性作為催化劑事件旨在回答一個提出的問題，即與 PD 1 單藥治療相比，ivonescimab 單藥治療所見的 PFS 益處是否會延續到本例中非小細胞肺癌的化療聯合治療中。正如上週所宣布的，在和諧六期中，ivonescimab 與化療的聯合治療中，在鱗狀非小細胞肺癌患者的一線治療中，取得了比 Tlazimab 與化療聯合治療具有統計學和臨床意義的 PFS 獲益。

(Syphilumab) is a standard of care, anti-PD1 therapy in China and Europe, and PD1 or PDL1 therapy plus chemotherapy is standard of care for first line patients without driver mutations in a non-small cell lung cancer in nearly all major markets globally. The full harmony 6 data set is planned to be presented at a major medical meeting later this year.

（Syphilumab）是中國和歐洲的標準抗 PD1 療法，而 PD1 或 PDL1 療法加上化療是全球幾乎所有主要市場中針對非小細胞肺癌無驅動突變患者的一線標準治療方法。完整的 Harmony 6 數據集計劃於今年稍後在一個大型醫學會議上展示。

Finally, data from the Harmony II trial conducted by our partners at Akeso in China provide insights regarding how the benefits seen with ivonescimab in progression free survival can translate to overall survival. After its groundbreaking PFS benefit over monotherapy Pembro, an early look at OS requested by the health authorities in China showed a strongly positive overall survival trend with a hazard ratio of 0.777. At 39% data maturity, implying a potential decrease of more than 22% in the risk of death for those patients receiving ivonescimab compared to Pembro.

最後，我們的合作夥伴康方生物在中國進行的 Harmony II 試驗的數據提供了有關 ivonescimab 在無進展生存期方面所取得的益處如何轉化為總體生存期的見解。在其突破性的 PFS 優於單一療法 Pembro 之後，中國衛生部門要求對 OS 進行早期觀察，結果顯示整體生存趨勢強勁積極，風險比為 0.777。數據成熟度為 39%，這意味著與接受 Pembro 治療的患者相比，接受 ivonescimab 治療的患者的死亡風險可能降低 22% 以上。

I would like to pause a moment to expand on these results. The early interim analysis for Harmony II was conducted at the request of the Chinese health authorities during the review of the study overall, which led to the second approval and label expansion for ivonescimab in China. This early look was conducted at just 39% data maturity in the trial. Because it was conducted at the request of the health authorities and had so few total events, the alpha allocated to this analysis was minimal at (0.001).

我想暫停一下來詳細闡述這些結果。Harmony II 的早期中期分析是在中國衛生部門對整個研究進行審查時應其要求進行的，這導致了 ivonescimab 在中國的第二次批准和標籤擴展。此次試驗的早期觀察數據成熟度僅 39%。由於這是應衛生當局的要求進行的，而且總事件數很少，因此分配給該分析的 alpha 值很小，（0.001）。

When we say alpha, this is statistical nuance, but effectively the goal was to provide the planned interim analysis and final analysis with the best statistical chance of success. Recall as well that this trial was sufficiently powered to show a statistically significant PFS benefit in order to gain approval in China, which it has already done. It was not powered and the design was not intended to show a statistically significant benefit.

當我們說 alpha 時，這是統計上的細微差別，但實際上目標是為計劃的中期分析和最終分析提供最佳的統計成功機會。還記得，這項試驗具有足夠的效力來顯示統計上顯著的 PFS 益處，從而獲得中國的批准，而且它已經獲得了批准。它沒有動力，而且設計目的也不在於顯示統計上顯著的益處。

When considering what an early look at OS requested by the Chinese health authorities, which few relative events in the trial not powered for overall survival means, statistical significance was not part of our consideration, focus, or expectations as indicated by Akeso minimal alpha spent, as we previously announced a planned interim analysis is expected roughly by the end of this year which will have a greater number of OS events.

當考慮到中國衛生部門要求的對 OS 進行早期觀察時，這意味著試驗中很少有相對事件對總體生存率沒有影響，統計意義不是我們考慮、關注或期望的一部分，正如康方生物最小 alpha 花費所表明的那樣，因為我們之前宣布的計劃中期分析預計在今年年底前進行，屆時將有更多的 OS 事件。

Note that Harmony VII, our global study of frontline patients with PDL1 high expressing non-small cell lung cancer, which intends to enroll 780 patients, nearly double the enrollment of Harmony II, is sufficiently covered to show a benefit in both PFS and OS. Context matters here.

請注意，Harmony VII 是我們針對 PDL1 高表達非小細胞肺癌一線患者進行的全球研究，該研究計劃招募 780 名患者，幾乎是 Harmony II 招募人數的兩倍，該研究覆蓋範圍足夠廣，可顯示出 PFS 和 OS 方面的益處。這裡的背景很重要。

What this health authority requested interim analysis did show was that at this early stage an early look at the data, if you will, overall survival already shows a strongly positive trend that is clinically meaningful. If Harmony seven were to show similar results at its final OS analysis, it is highly probable that this would result in a statistical significant overall survival benefit being achieved. This first look at overall survival data for Harmony II combined with a strong PFS result in Harmony six is remarkable.

衛生當局要求的中期分析確實表明，在早期階段，如果你願意的話，對數據的早期觀察，總體生存率已經顯示出具有臨床意義的強烈積極趨勢。如果 Harmony Seven 在最終 OS 分析中顯示出類似的結果，則很有可能實現統計上顯著的整體存活獲益。首次查看 Harmony II 的整體存活數據，結合 Harmony Six 的強勁 PFS 結果，結果非常引人注目。

This data in to with previously disclosed data for Harmony A and PFS data for harmony II, as well as the earlier phase trials in and outside of non-small cell lung cancer conducted by Akeso, further validate that ivonescimab is canistically disend from PD1 inhibitors and has the potential to make a meaningful positive impact for patients facing difficult cancer diagnosis. We are thrilled with the data released last week in both the statistically significant PFS results from the first interim analysis in Harmony and the early look requested by an MPA at survival in Harmony II.

這些數據與先前揭露的 Harmony A 數據和 Harmony II 的 PFS 數據以及康方生物在非小細胞肺癌領域內外進行的早期試驗相結合，進一步驗證了 Ivonescimab 可與 PD1 抑製劑進行選擇性結合，並有可能為面臨困難癌症診斷的患者帶來有意義的積極影響。我們對上週發布的數據感到非常興奮，這些數據包括 Harmony 的第一次中期分析中具有統計意義的 PFS 結果以及 MPA 要求的 Harmony II 生存早期觀察。

In speaking with the key opinion leaders, we have received very positive feedback. Our KOLs are highly encouraged by the potential ivonescimab. This is consistent with the published feedback of multiple top thoracic KOL in media articles over the past week.

在與關鍵意見領袖交談時，我們收到了非常正面的回饋。我們的 KOL 對 ivonescimab 的潛在價值感到非常鼓舞。這與過去一週多位頂級胸腔科KOL在媒體文章中發表的回饋一致。

Additionally, Akeso continues to enroll multiple phase three clinical trials, including biliary tract cancer, pancreatic cancer, triple negative breast cancer, and head and neck cancer and intends to launch an additional phase three study in second line or later non-small cell lung cancer after progression on immunotherapy. Now I would like to take a moment to review study design for our two ongoing global phase three trials, harmony three and harmony seven.

此外，康方生物也持續招募多項三期臨床試驗，包括膽道癌、胰臟癌、三陰性乳癌和頭頸癌，並計劃在免疫治療進展後的二線或後期非小細胞肺癌中啟動一項額外的三期研究。現在，我想花點時間回顧我們正在進行的兩項全球第三階段試驗，即 Harmony Three 和 Harmony Seven 的研究設計。

For those on the webcast, this slide shows the study designed for Harmony three. Harmony three is a randomized double blind global phase three clinical trial evaluating ivonescimab in combination with chemotherapy against Pembro in combination with chemotherapy as first line treatment for patients with metastasis. Non-small cell lung cancer.

對於網路直播中的人來說，這張投影片展示了為 Harmony 3 設計的研究。Harmony Three 是一項隨機雙盲全球三期臨床試驗，評估 Ivonescimab 聯合化療對比 Pembro 聯合化療作為轉移性患者一線治療的效果。非小細胞肺癌。

This trial includes patients with squamous or non-squamous histology with no activating activating genomic alterations regardless of PDL one expression, including high, low, and negative PDL1 expressing tumors. Your primary endpoints for harmony three include progression free survival and overall survival, and results will be stratified by squamous and non-squamous histology.

本試驗包括鱗狀或非鱗狀組織學患者，無論 PDL 1 表現如何，均無活化基因組改變，包括高、低和陰性 PDL1 表達腫瘤。和諧三的主要終點包括無惡化存活期和整體存活期，結果將根據鱗狀和非鱗狀組織學進行分層。

As we have discussed, Harmony six from our partner Akeso in China met its primary endpoint, achieving statistically significant and clinically meaningful improvement in progression free survival for ivonescimab with chemotherapy against PD1 therapy, with chemotherapy in frontline treatment of patients with squamous no small cell lung cancer, regardless of PDL1 expression.

正如我們所討論的，我們的合作夥伴中國康方生物的 Harmony Six 達到了其主要終點，即在鱗狀非小細胞肺癌患者的一線治療中，ivonescimab 與化療聯合 PD1 療法相比，在無進展生存期方面取得了統計學上和臨床上有意義的改善，無論 PDL1 表達如何。

This results from a Akeso trial conducted in China further validate our conviction and the potential for this study. We look forward to the full harmonyistic data set being presented at the major medical conference later this year.

康方生物在中國進行的一項試驗的結果進一步驗證了我們的信念和這項研究的潛力。我們期待在今年稍後的大型醫學會議上展示完整的和諧數據集。

Next, we have the study designed for hormony seven, a randomized double blind global phase three clinical trial evaluating ivonescimab monotherapy against Pembro, monotherapy as first line treatment for metastatic non small cell lung cancer patients with tumors with high PDL1 expression.

接下來，我們有針對 Hormony Seven 設計的研究，這是一項隨機雙盲全球三期臨床試驗，評估 Ivonescimab 單藥治療對比 Pembro 單藥治療作為 PDL1 高表達轉移性非小細胞肺癌患者的一線治療。

Duual primary endpoint for Harmony seven includes progression free survival, and overall survival and results will be stratified by squamous and non-squamous histologies. As a reminder, our Harmony seven study shares similarity with the Akeso sponsored Harmony two phase three trial, but focuses on those patients who who whose tumors have a high PDL-1 expression for which monotherapy Pembro is a current standard of care in the United States and other major Western markets.

Harmony Seven 的雙重主要終點包括無惡化存活期和總存活期，結果將根據鱗狀和非鱗狀組織學進行分層。提醒一下，我們的 Harmony 7 期研究與康方生物贊助的 Harmony 2 期三期試驗有相似之處，但重點關注那些腫瘤具有高 PDL-1 表達的患者，而單一療法 Pembro 是美國和其他主要西方市場的當前治療標準。

Turning to the market opportunity, ivonescimab has the potential to be a platform blockbuster drug and is well positioned to make a significant impact across the treatment landscape of non-small cell lung cancer and beyond. In non-small cell lung cancer alone, there are combined seven announced or ongoing phase three studies conducted by either Akeso or Summit.

談到市場機遇，ivonescimab 有潛力成為平台重磅藥物，並有望對非小細胞肺癌及其他領域的治療產生重大影響。僅在非小細胞肺癌領域，康方生物或 Summit 已宣布或正在進行七項三期研究。

According to third party research, including TD Cohen and others, the non-small cell lung cancer addressable market is expected to approach 20 billion for checkpoint inhibitors. With the recent data announced by our partner Akeso in China, our belief is further validated in the potential for ivonescimab to make a significant difference for patients with non-small cell lung cancer. Beyond non-small cell lung cancer across all checkpoint inhibitors in indications, the addressable market approaches 90 billion globally in further in future years, according to ITVO research.

根據包括 TD Cohen 等在內的第三方研究，非小細胞肺癌檢查點抑制劑目標市場規模預計將接近 200 億美元。隨著我們的合作夥伴中國康方生物最近公佈的數據，我們進一步相信 ivonescimab 有可能為非小細胞肺癌患者帶來顯著的改變。ITVO 的研究顯示，除了適用於所有適應症的檢查點抑制劑的非小細胞肺癌外，未來幾年全球潛在市場規模將進一步接近 900 億美元。

But as we have been discussing, while the checkpoint inhibitor market opportunity is significant, the potential opportunity that I just mentioned does not include the full impact that ivonescimab could have given it has shown promising data in multiple tumor types where checkpoint inhibitors have not. Be effective. This includes macrosatellite, stable colorectal cancer, PDL1 low, and negative triple negative breast cancer, and EGFR mutant non-small cell lung cancer after targeting targeted therapy based on the phase two studies conducted by Akeso.

但正如我們一直在討論的那樣，雖然檢查點抑制劑市場機會巨大，但我剛才提到的潛在機會並不包括 ivonescimab 可能帶來的全部影響，它已經在多種腫瘤類型中顯示出有希望的數據，而檢查點抑制劑還沒有。有效。其中包括以康方生物為基礎進行的第二階段臨床研究的標靶治療後的大衛星、穩定性結直腸癌、PDL1低、陰性三陰性乳癌、EGFR突變非小細胞肺癌等。

In total, there are more than 50 indications where PD1, PDL1, or B therapies have been approved. All areas for ivonescimab to potentially offer patients with cancer and. Improved treatment option. ivonescimab will continue to be appropriately rapidly tested and developed beyond non-small cell lung cancer.

總計有超過 50 種 PD1、PDL1 或 B 療法獲得批准。Ivonescimab 有可能為所有癌症患者提供治療。改進的治療選擇。 ivonescimab 將繼續在非小細胞肺癌之外進行適當快速的測試和開發。

I continue to applaud the work of the summit and its rapid advancement in the development of ivonescimab which only two years ago began to open the first clinical site ever in the United States for ivonescimab. We persistently evaluate opportunities to accelerate our. Timeline in bringing additional therapeutic options to patients with high unmet cancer needs I look forward to upcoming announcements regarding expansions to our clinical development pipeline. With that update, I will now ask Manmeet to provide details on our financial and operational update.

我繼續讚揚峰會的工作及其在 ivonescimab 研發方面的快速進展，僅在兩年前，峰會才開始在美國開設第一個 ivonescimab 臨床站點。我們堅持不懈地評估加速我們發展的機會。為癌症需求未得到滿足的患者提供更多治療選擇的時間表我期待即將發布的有關擴大我們的臨床開發管道的公告。有了該更新，我現在將要求 Manmeet 提供有關我們的財務和營運更新的詳細資訊。

Thank you, Maky, and good afternoon, everyone. We issued this afternoon our earnings release for the first quarter of 2025. Today, in addition to providing you with an update on our cash position and operating expenses, I will also provide you color on our clinical, commercial, and manufacturing operations. Let me start with an update on the clinical operations front. As Maky mentioned earlier, we expanded Harmony three clinical trial during the fourth quarter of 2024 to add non-squamous patients.

謝謝你，Maky，大家下午好。我們今天下午發布了 2025 年第一季的財報。今天，除了向您提供我們的現金狀況和營運費用的最新情況外，我還將向您介紹我們的臨床、商業和製造營運的情況。首先讓我介紹一下臨床操作的最新情況。正如 Maky 之前提到的，我們在 2024 年第四季擴大了 Harmony 第三期臨床試驗，以增加非鱗狀患者。

We are very pleased with the rate of enrollment across the Harmony three trial for both squamous and non-squamous patients in the United States and Europe. In addition, very recently in 2025, we have initiated enrollment for patients in Harmony VII clinical trial in the United States. We expect to initiate enrollment for the other regions during the next quarter based on the regulatory clearances to begin activating sites later this quarter.

我們對美國和歐洲的 Harmony 三項試驗中鱗狀和非鱗狀患者的入組率感到非常滿意。此外，就在最近的2025年，我們已經開始在美國招募Harmony VII臨床試驗的患者。我們預計將在下個季度根據監管部門的批准啟動其他地區的招生，並在本季晚些時候開始啟動站點。

With our expected top line results from Harmony trial during the middle of this year, we have initiated preparations for our first potential commercial launch of ivonescimab. We recently strengthened our leadership team with the appointment of Robert LaCaze as our Chief Commercial Officer. Robert is a seasoned biopharmaceutical executive with over 30 years of extensive leadership experience in commercial strategy and execution.

隨著我們預計今年年中 Harmony 試驗的頂線結果出來，我們已經開始為 ivonescimab 的首次潛在商業發布做準備。我們最近任命羅伯特·拉卡茲 (Robert LaCaze) 為首席商務官，加強了我們的領導團隊。羅伯特是一位經驗豐富的生物製藥主管，在商業策略和執行方面擁有 30 多年的豐富領導經驗。

Prior to joining Summit, he held senior positions at major pharmaceutical companies, including Bayer Healthcare and Bristol-Myers. With a proven track record of launching and growing blockbuster oncology franchises, Robert joins our team at the right time as we continue to define our commercial strategy and expand our capabilities.

在加入 Summit 之前，他曾在拜耳醫療保健和百時美施貴寶等大型製藥公司擔任高階職位。羅伯特在推出和發展重磅腫瘤學特許經營方面擁有良好的記錄，在我們繼續制定商業策略和擴展我們的能力之際，他加入了我們的團隊。

In addition to Robert, we have also hired key hires for market access, marketing, and sales to the commercial launch strategy. On the drug manufacturing front, in addition to our current supply source for ivonescimab from Akeso, our collaboration partner, we have made significant progress in transferring relevant know-how to certain third-party contract manufacturers in our licensed territory.

除了羅伯特之外，我們還聘請了負責市場准入、行銷和銷售以及商業發布策略的關鍵人員。在藥品製造方面，除了我們目前的合作夥伴康方生物的ivonescimab供應來源外，我們在將相關技術轉移給我們許可區域內的某些第三方合約製造商方面也取得了重大進展。

Also, we are very pleased with the first approval of a casos PD one inhibitorenpoliab by the US FDA, which demonstrates a Akeso's capability to adhere to global manufacturing and quality standards. On the financial front, let me start with our cash position. We ended the first quarter of 2025 with a strong cash position of approximately USD361 million. Let me remind you that we paid off our debt in entirety during the fourth quarter of 2024 and are now debt free.

此外，我們非常高興美國 FDA 首次批准 casos PD one inhibitorenpoliab，這表明康方生物有能力遵守全球製造和品質標準。在財務方面，讓我先從我們的現金狀況開始。截至 2025 年第一季度，我們的現金狀況強勁，約為 3.61 億美元。讓我提醒您，我們在 2024 年第四季已全部還清債務，現在已無債務。

Turning to operating expenses, I'll provide details on both GAAP and non-gap numbers. You can refer to our press release issued this afternoon for a reconciliation of GAAP to non-gap financial measures. As a reminder, non-gap expenses exclude stock-based compensation expenses.

談到營運費用，我將提供 GAAP 和非差距數字的詳細資訊。您可以參考我們今天下午發布的新聞稿，以了解 GAAP 與非差距財務指標的對帳。提醒一下，非差距費用不包括股票薪酬費用。

Our GAAP R&D expenses during the first quarter of 2025 were USD51.2 million compared to USD51.4 million for the fourth quarter of 2024. And non-gap R&D expenses were USD47.1 million for both first quarter of 2025 and for the fourth quarter of 2024. Our GAAP R&D expenses for the first quarter of 2025 remain flat as compared to the last quarter of 2024. Our GAAP, GNA expenses during the first quarter of 2025 were USD15.6 million compared to USD14.2 million for the fourth quarter of 2024.

我們 2025 年第一季的 GAAP 研發費用為 5,120 萬美元，而 2024 年第四季為 5,140 萬美元。2025 年第一季及 2024 年第四季的非差距研發費用均為 4,710 萬美元。我們 2025 年第一季的 GAAP 研發費用與 2024 年最後一季相比持平。我們 2025 年第一季的 GAAP、GNA 費用為 1,560 萬美元，而 2024 年第四季為 1,420 萬美元。

And non-gap G&A expenses were USD8.6 million during the first quarter of 2025 compared to USD7.5 million for the fourth quarter of 2024. Our GAAP GNA expenses primarily increased due to an increase in professional services to support the development of map. Overall, our non-gap operating expenses during the first quarter of 2025 were USD55.7 million compared to USD54.6 million for the previous quarter. The increase in non-gap operating expenses were primarily related to an increase in GNA expenses as noted above. And with that I'll hand it back over to Dave.

2025 年第一季的非差距 G&A 費用為 860 萬美元，而 2024 年第四季為 750 萬美元。我們的 GAAP GNA 費用增加主要是由於支援地圖開發的專業服務的增加。整體而言，我們 2025 年第一季的非缺口營運費用為 5,570 萬美元，而上一季為 5,460 萬美元。非差距營運費用的增加主要與上述 GNA 費用的增加有關。說完這些，我就把它交還給戴夫。

Thank you, Bob McKee and my. We are now, we will now see if there are any questions that our team can help answer. Dustin, please open the line for questions.

謝謝你，鮑伯麥基和我。我們現在將看看是否有任何問題，我們的團隊可以幫助解答。達斯汀，請打開熱線來回答問題。

(Operator Instructions)

（操作員指示）

The first question comes from the line of Salvin Richard from Goldman Sachs. The line's open.

第一個問題來自高盛的薩爾文‧理查德 (Salvin Richard)。線路已開通。

Hey team, this is Mark on for Salvin. Thank you so much for taking our question and congrats on the quarter. Couple questions on the upcoming Harmony EGFR data set. So I think everyone's going to be focused on sort of the subgroup data to confirm if because those prior data generated in China translates to Western regions.

嘿，團隊，我是 Salvin 的馬克。非常感謝您回答我們的問題，並祝賀本季度取得的成績。關於即將推出的 Harmony EGFR 資料集的幾個問題。因此，我認為每個人都會關注子群數據，以確認是否因為先前在中國產生的數據可以轉化為西方地區。

So what do you believe the bar for success here is in this context? Like how closely does the data have to mirror Harmony A to support the translatability, and also. In the context of (Rybervan's) approval on (Mariposa 2), what profile are you hoping to see from Harmony, to and sort of what level of benefit do you believe would convince Docs to use (ivonescimab and second line E year far)? Thanks.

那麼，您認為在這種情況下成功的標準是什麼？例如，數據必須與 Harmony A 有多接近才能支援可翻譯性，等等。在 Rybervan 批准 Mariposa 2 的背景下，你希望 Harmony 帶來什麼好處？你認為 Harmony 會帶來什麼好處？（ivonescimab 和二線 E 年還有多遠）？謝謝。

Thanks, Mark, for the question. I'll give a couple words and then I'm going to hand it over to Jack West, our thoracic oncology lead. I think in terms of your first question, we're not going to necessarily prescribe a bar or a specific number that we're looking to achieve. I think the overall data package consistency.

謝謝馬克提出這個問題。我會講幾句話，然後我會把它交給我們的胸腔腫瘤科負責人傑克·韋斯特 (Jack West)。我認為就您的第一個問題而言，我們不一定會規定我們想要達到的標準或具體數字。我認為整體數據包一致性。

Or the data package and the general consistency with the data that comes from China will be the important piece, the global consistency, if you will. We're not interested in setting a bar that'll be part of the discussions with the agency, but with respect to the second part of the question, I'll hand that over to Jack.

或者說，資料包和來自中國的資料的整體一致性將是重要的部分，即全球一致性，如果你願意的話。我們對與該機構討論時設定標準不感興趣，但關於問題的第二部分，我將把它交給傑克。

Hi, this is Jack West. So I would comment that obviously the entire field of EGFR mutation positive non-small cell has become much more complex over the last couple of years with a lot of new options, but that still leaves plenty of open space for new choices.

你好，我是傑克韋斯特。因此我想說的是，顯然，在過去幾年中，整個 EGFR 突變陽性非小細胞領域變得更加複雜，出現了許多新的選擇，但仍然留下了大量新的選擇空間。

One would be that with The potential for (ivonescimab) and (lazartinib) to be used in the first line second setting, that leaves a need for another option that is very appropriate for the harmony platform, to fill. Obviously, that's not going to be everybody and there's going to be patients who get (Osamertinib) monotherapy or the (flora2) approach with a combination of chemotherapy and (osamertinib), but obviously, ivonescimab with chemo has a combination of efficacy with toxicity liabilities that looks very different from what chemo and ivonescimab offers.

一方面，由於 (ivonescimab) 和 (lazartinib) 有可能用於一線二線治療，因此需要另一個非常適合 Harmony 平台的選項來填補。顯然，這並不是每個人都能做到的，有些患者會接受奧沙替尼 (Osamertinib) 單一療法或化療與奧沙替尼 (osamertinib) 聯合治療 (flora2)，但顯然，ivonescimab 聯合化療的療效和毒性作用與單純化療和 ivonescimab 的療效和毒性作用截然不同。

I have had extensive discussions with clinicians in all sorts of settings, academic and community-based, and There's really a strong sense that there's a value and a great need for alternatives that have a very different and potentially less challenging toxicity profile. Obviously, efforts are made in ways to ameliorate the toxicities with ivonescimab, but there will always be a value in choices.

我與各種環境下的臨床醫生（包括學術和社區醫生）進行了廣泛的討論，他們強烈地感覺到，具有非常不同且潛在毒性較小的替代品具有價值並且非常有必要。顯然，人們正在努力嘗試減輕 ivonescimab 的毒性，但選擇總是有價值的。

That makes sense. Thank you.

這很有道理。謝謝。

Thank you. Our next question comes from the line of Egan Chomaditz from Citigroup. The line's open.

謝謝。我們的下一個問題來自花旗集團的 Egan Chomaditz。線路已開通。

Hi, everyone. Thank you very much for taking the questions and congrats on the very positive recent developments.

大家好。非常感謝您回答這些問題，並對最近的積極進展表示祝賀。

My question also on harmony, could you just be more specific in terms of what will we see with respect to the geographic data, meaning China versus ex-China patients? Are we going to be getting separate hazard ratios on PFS and OS for each of these geographies? Would it be something in the form of a forest plot? Or would it just be some kind of a more qualitative statement around potential comparability? That's my first question. Thank you.

我的問題也是關於和諧的，您能否更具體地說明我們將看到哪些地理數據，即中國患者與中國以外的患者？我們是否會針對每個地區獲得單獨的 PFS 和 OS 風險比？它會是森林地塊形式的東西嗎？或者它只是某種有關潛在可比性的更定性的陳述？這是我的第一個問題。謝謝。

Thanks Egan. This is Dave. I think I would break that down into two points, one of which is, the true top line. Data if you will that typically will be a little bit more qualitative, right? Major medical conferences that presentation obviously will have a bit more detail. It'll certainly give some context to geographic breakdowns in a forest plot is certainly one way to do that. We'll make those those final decisions, but the goal will be to give appropriate context with respect to the breakdowns between. A North American and European patients as compared to those enrolled in China.

謝謝 Egan。這是戴夫。我想將其分為兩點，其中一點是真正的頂線。如果您願意的話，數據通常會更加定性，對嗎？大型醫學會議的演講顯然會更詳細一些。它肯定會為森林圖中的地理分佈提供一些背景信息，這當然是實現這一目標的一種方法。我們將做出這些最終決定，但目標是針對其中的故障提供適當的背景資訊。與中國患者相比，北美和歐洲患者的情況有所差異。

Okay, thanks. And then two more on harmony with respect to timing you consistently said mid 2025. Is it fair to assume that we would see harmony before we see Harmony two and Harmony six, which you've alluded to would be at the fall medical meetings, and then also with Harmony, what is your view on whether you need OS to beat (ig) for a competitive filing in the United States? Thanks.

好的，謝謝。然後關於時間方面的和諧，您一直說是 2025 年中期。在我們看到 Harmony 2 和 Harmony 6 之前，我們是否可以公平地假設我們會看到 Harmony，您曾提到這將在秋季醫學會議上，然後還有 Harmony，您認為是否需要 OS 來擊敗 (ig) 在美國進行競爭性申請？謝謝。

Sure, with respect to the timing of the excuse me, the timing of the data releases that will that'll come down ultimately to which conference, especially in the fall, takes which which presentation and whatnot and some of that strategic in terms of, where and when that'll be, displayed in terms of.

當然，關於數據發布的時間，對不起，數據發布的時間最終將取決於哪個會議，特別是在秋季，將採取哪個演示等等，以及在何時何地展示的一些戰略性因素。

The timing across them, I don't know that we have a specific order in terms of one versus the other. What I would say is we would expect top line data for harmony in in in the middle of 2025, I would think by the time you get into (ESMO), that that's more in October, so you're a little later there so I can't give you (inaudible) yet which conference will different data will go where, but there should certainly be at least top line before we get to, the end of Q3, beginning of Q4, hopefully that's helpful. Can you repeat your second question, Egan?

對於它們之間的時間安排，我不知道我們是否有特定的順序。我想說的是，我們預計在 2025 年中期會獲得 Harmony 的頂線數據，我認為到 ESMO 的時候，也就是 10 月份，所以時間會晚一些，所以我不能告訴你（聽不清楚）哪個會議會將不同的數據發佈到哪裡，但在我們到達第三季度末、第四季度初線之前，至少應該會有頂線幫助這會有所幫助。你能重複一下你的第二個問題嗎，伊根？

Oh, I was just curious about the relative importance of hitting on OS in harmony to have a competitive BOA filing.

哦，我只是好奇和諧地達到 OS 對於具有競爭力的 BOA 文件的重要性。

Yeah, I think at this point it's important to say, we have two primary endpoints. We want to be clear on that. I think the other piece becomes the totality of the package, importantly, I'll ask Jack or Allen to add any context here, but in the second line, EGFR mutant non-small cell lung cancer space post the TKI overall survival hasn't been. Seeing at this point to show a statistically significant benefit in any regimen, and so that would be part of the context, but importantly, as you noted, we have two primary endpoints, so it'll be a total package consideration there.

是的，我認為現在有必要說一下，我們有兩個主要終點。我們想明確這一點。我認為另一部分成為了整個方案的全部，重要的是，我會請傑克或艾倫在這裡添加任何背景信息，但在第二行中，EGFR 突變非小細胞肺癌空間在 TKI 治療後的總生存期尚未確定。從這一點來看，任何方案都顯示出統計上顯著的益處，因此這將是背景的一部分，但重要的是，正如您所說，我們有兩個主要終點，因此這將是一個全面的考慮。

Yeah, this is Allen Yang Egan. I don't have much to add except that, the precedent in this space has not been, it's not been needed to hit OS to get an approval. Of course we would like to show clear benefit for ivonescimab in this space, but I think, it's wonderful for patients that there's going to be multiple choices for them, as Jack alluded to. I think this is unfortunately a palliative setting, so I think a lot of things will go into the physicist's mind about what to to use, efficacy as well as toxicity profiles and so forth.

是的，我是 Allen Yang Egan。我沒有什麼可補充的，只是這個領域的先例還沒有，不需要透過 OS 來獲得批准。當然，我們希望展示 ivonescimab 在這一領域的明顯優勢，但我認為，正如傑克提到的那樣，對於患者來說，擁有多種選擇是一件很棒的事情。我認為不幸的是，這是一種安寧療護，所以我認為物理學家會考慮很多事情，例如使用什麼、功效以及毒性概況等等。

And maybe if I could just squeeze one in, maybe for you, Allen, maybe Jack, obviously the Pfizer partnership for the ABCs is great, however, that one is missing some of the more perhaps relevant targets in non-small cell lung cancers such as a (rope 2 or HER2 HR3). So how are you thinking about that aspect of a longer term strategy in lung cancer to combine potentially down the road with those types of ADCs?

也許我可以插一句，也許對你來說，艾倫，也許傑克，顯然輝瑞在 ABC 方面的合作很棒，但是，它缺少一些在非小細胞肺癌中更相關的靶點，例如（繩 2 或 HER2 HR3）。那麼您如何看待肺癌的長期策略與未來可能與這些類型的 ADC 相結合？

Yeah, golf, that's a great question. So again, I think the landscape of cancer is changing very quickly, which is terrific. I think Pfizer is a great partnership. They have a great pipeline. Of ADCs, we're not sort of wedded to the pipeline. We're open to it, ivonescimab is our is our only child really, and so we are open to other collaborations as well. And so we continue to follow the lung lung cancer landscape and we're open to whatever is the best treatment for patients.

是的，高爾夫，這是一個很好的問題。所以，我認為癌症的情況正在迅速變化，這是非常好的。我認為輝瑞是一家非常棒的合作夥伴。他們擁有出色的管道。對於 ADC，我們並不拘泥於管道。我們對此持開放態度，ivonescimab 確實是我們唯一的孩子，因此我們也對其他合作持開放態度。因此，我們將繼續關注肺癌的發展情況，並願意為患者提供最佳的治療方法。

And we, this is Jack West, we do have other combinations that are being evaluated and In potential development in settings like ISTs and even cooperative group efforts. So, we're quite open to an array of options that will give us a lot of combination opportunities.

而我們，我是傑克·韋斯特，我們確實有其他組合正在接受評估，並且在 IST 甚至合作小組努力等環境中具有潛在發展潛力。因此，我們對一系列能夠為我們提供大量組合機會的選擇持開放態度。

Okay, thank you so much.

好的，非常感謝。

Thank you. Our next question comes from the line of Corey Casamogh from Evercore. The line's open.

謝謝。我們的下一個問題來自 Evercore 的 Corey Casamogh。線路已開通。

Hey, good afternoon guys, thanks for taking the questions. I'll stick the two of them, I guess. First one is for Harmony two, you obviously showed pretty profound PFS benefits across all cuts of the data and histologies, everything else. Would you expect that to broadly hold for overall survival as well? And then I'll have a follow up.

嘿，大家下午好，感謝你們回答問題。我想我會堅持他們兩個。第一個是對於 Harmony 2，您顯然在所有數據和組織學以及其他所有方面都展示了相當顯著的 PFS 優勢。您是否認為這對於整體存活率也同樣適用？然後我會跟進。

Hey Corey, great question. This is Dave. At this point, the only data that's that's been released publicly from our partners at Akeso has been the top line hazard ratio for Harmony II.

嘿，科里，好問題。這是戴夫。目前，我們的合作夥伴康方生物公開發布的唯一數據是 Harmony II 的最高風險比。

So to your point, you were correct in the consistency of the PFS data within Harmony II. But I don't want to get in front of our partners in terms of data release with respect to subgroups or anything like that but the be beyond going beyond the top line overall survival has a ratio that they provided.

因此，就您的觀點而言，您對 Harmony II 中的 PFS 資料的一致性的看法是正確的。但我不想在有關亞組或類似數據發布方面超越我們的合作夥伴，但超越頂線總體生存率有一個他們提供的比例。

Okay, understood. And then a question we get a lot I want to ask you is, do you expect safety trends in the global population, whether it's the Harmony study or some of your following ones to match what's been seen in the data sets coming out of China? What would be the rationale as to why it could be different?

好的，明白了。然後我想問您的一個問題是，您是否預期全球人口的安全趨勢（無論是 Harmony 研究還是您後續的一些研究）會與中國資料集中看到的情況相符？為什麼會有所不同，原因何在？

So Corey, I just want to make sure I understand your question. You're asking for the rationale in terms of why the data would be different between China. (multiple speakers)

所以科里，我只是想確保我理解你的問題。您詢問的是為什麼中國之間的數據有差異。（多位發言者）

yeah, on the safety front.

是的，就安全方面而言。

Okay, I'll hand that one over to Jack if you want to, speak to that at all.

好的，如果你願意的話，我會把這個交給傑克，談談這個。

Yeah, this is Alan Yang. Corey, I think I understand the question. So let me say one thing first. So there's now at least two randomized data sets that have been publicly disclosed, the Harmony A and the Harmony II, in terms of safety, and we're really happy with the safety profile reported to ivonescimab. This is against double blind one is placebo controlled, and the other one is against (Pembroism) now.

是的，我是艾倫楊。科里，我想我明白了這個問題。那麼讓我先說一件事。因此，就安全性而言，現在至少有兩組隨機資料集已公開披露，即 Harmony A 和 Harmony II，我們對報告的 ivonescimab 的安全性感到非常滿意。這是針對雙盲的，一個是安慰劑對照，另一個是針對（彭布羅氏症）的。

So we believe that the safety profile looks really good, especially since the investigators didn't know which drug was going, they're getting and so they're reporting the adverse events sort of, in an unbiased approach. In terms of differences in safety reporting in China versus the US, I don't think there's going to be anything significant. Remember, even in global studies today, especially in lung cancer, a large proportion of the studies report data from China.

因此，我們認為安全性看起來確實很好，特別是因為研究人員不知道他們正在使用哪種藥物，所以他們以公正的方式報告不良事件。就中國和美國的安全報告差異而言，我認為不會有任何重大差異。請記住，即使在當今的全球研究中，尤其是在肺癌領域，很大一部分研究報告的數據來自中國。

The investigators are Chinese and now they're being significant contributors to those global studies. There are slight differences and Standard of care or cultural differences in reporting AEs. We've noticed that in the Harmony A study, a lot of lab values were reported. The Chinese investigators seem to be more conservative in reporting lab value abnormalities.

研究人員是中國人，現在他們正在為這些全球研究做出重要貢獻。在報告不良事件方面存在細微的差異以及護理標準或文化差異。我們注意到，在 Harmony A 研究中報告了許多實驗室值。中國研究人員在報告實驗室值異常方面似乎更加保守。

As adverse events, even though there may not be clinically significant or meaningful adverse events associated with those lab value abnormalities. So with that said, I don't expect there to be differences, but there are some sort of cultural or minor differences, but I don't think that they will be impactful on the data.

作為不良事件，即使與這些實驗室值異常相關的可能沒有臨床上顯著或有意義的不良事件。所以話雖如此，我並不認為會有差異，但確實存在某種文化或細微的差異，但我不認為它們會對數據產生影響。

And I would also just add, Jack West that, the things that to the clinicians are going to be of greatest concern are Serious bleeding issues or things that are not nuanced questions that would be subject to that kind of interpretation. I think the, and the data that we've seen have been so well ensconced in a In a place where clinicians are happy that it would, it would have to be a very notable departure from anything that's been seen at this point in larger trial settings prospectively moving forward.

我還要補充一點，傑克·韋斯特，臨床醫生最關心的是嚴重出血問題，或者那些不需要進行此類解釋的細微問題。我認為，我們所看到的數據已經得到了很好的證實，在臨床醫生滿意的情況下，它必須與目前在更大規模的試驗環境中看到的任何情況有非常顯著的不同，並且具有前瞻性。

Okay, yeah, we found the safety language in the Akeso press release on Harmony 6 to be very reassuring, but that answer is very helpful. I appreciate it guys. Thank you.

好的，是的，我們發現康方生物在 Harmony 6 新聞稿中的安全語言非常令人放心，但這個答案非常有幫助。我很感謝你們。謝謝。

Thank you. Our next question comes from the line of Kelly Shi from Jeffries. The line's open.

謝謝。我們的下一個問題來自 Jeffries 的 Kelly Shi。線路已開通。

Congrats on the progress and my first question is for Harmony 3, the chemo combo trial in frontline, do you set enrollment target for squamous and the non-squamous, versus non-squamous patients? Is it expected to be split equally across two subtypes and also have a follow up?

恭喜您取得進展，我的第一個問題是，對於 Harmony 3，即一線化療組合試驗，您是否針對鱗狀細胞癌和非鱗狀細胞癌以及非鱗狀細胞癌患者設定了入組目標？是否預計它會被平等地分為兩種亞型並且還有後續行動？

Allen, do you want to take that question?

艾倫，你想回答這個問題嗎？

Yeah. We do have sort of enrollment objectives for both the pathologies so that we would have enough scientific information to have an informed decision on both histologies. We haven't disclosed the exact numbers and they're not precise. They're sort of ranges of the expectations, so there's got to be equal amounts of squamous and non-squamous at the end of the study.

是的。我們確實對這兩種病理都有某種招募目標，以便我們有足夠的科學資訊來對這兩種組織學做出明智的決定。我們尚未透露確切的數字，而且這些數字並不精確。它們是一種預期範圍，因此在研究結束時鱗狀細胞和非鱗狀細胞的數量必須相等。

Great. And also for Harmony 7, the global trial running by summit in the PDL1 positive patient, what kind of media overall survival benefit in terms of like how many months of improvement over PD1 would be considered transformative and replace PD one standard of care. In this front line, settings.

偉大的。對於 Harmony 7，即由 Summit 針對 PDL1 陽性患者進行的全球試驗，什麼樣的媒體整體生存獲益（例如比 PD1 改善多少個月）將被視為變革性的並取代 PD 的一種治療標準。在此前線，設定。

Hey Kelly, this is Dave. I would just want to say we did, we haven't given our statistical plan yet in terms of this. I'll let. The physician's comment on the clinically meaningful thresholds and whatnot, but I, in terms of what we're like gearing the trial for and whatnot, that's not necessarily a plan we've given. The only thing I would say from a top line perspective, I think we're, we've been pretty clear publicly that, as we look at overall survival, being around or under the 0.80 hazard ratio has been a focus for us, but I'll let Jack if there's anything else around you want to add to that.

嘿凱利，我是戴夫。我只是想說我們已經制定了，但尚未就此給出統計計劃。我讓。醫生對具有臨床意義的閾值等的評論，但就我們為試驗所做的準備等而言，這不一定是我們給出的計劃。從頂線角度來看，我唯一想說的是，我認為我們已經公開表示得很清楚，當我們考慮總體生存率時，保持在 0.80 左右或以下的風險比一直是我們關注的重點，但如果傑克還有其他想補充的，我會告訴你的。

Yeah, this is Jack West. I think that Dave underscored all the right points that In general, I would say that if it is, statistically significant to make this a positive trial, it is extremely likely that it will be more than sufficient from a clinicians standpoint to be clinically significant and revise the standard of care.

是的，這是傑克·韋斯特。我認為戴夫強調了所有正確的觀點，總的來說，我想說，如果它具有統計意義，使這成為一次積極的試驗，那麼從臨床醫生的角度來看，它極有可能足以具有臨床意義並修改護理標準。

I would say that the statistical plan is likely to be more stringent than than what clinicians or patients are looking for as a clinically meaningful improvement and that as a general statement that most clinicians looking for, are looking for two or three months at least of an improvement in overall survival. So, but that's not specific to this trial, that just is a general benchmark of practice changing.

我想說的是，統計計劃可能比臨床醫生或患者所尋求的具有臨床意義的改善更為嚴格，並且一般而言，大多數臨床醫生都在尋求至少兩三個月的總體生存率改善。所以，但這並不是針對這次試驗的，這只是實踐改變的一般基準。

Yeah, I just underscore what Jack said. You know that we haven't really released those specifics around our statistical analysis plan, but if the Harmony VII study is positive that's designed, it would be very clinically meaningful and an important change in the standard of care. I'd also add like if you look at the Harmony II data presented to date, if those numbers hold up, I think that's very clinically meaningful and important data. I agree, yeah.

是的，我只是強調傑克所說的話。您知道我們還沒有真正公佈有關統計分析計劃的具體細節，但如果 Harmony VII 研究是積極的，那麼它將具有非常大的臨床意義，並且是護理標準的一個重要變化。我還要補充一點，如果你看迄今為止提供的 Harmony II 數據，如果這些數字成立，我認為這是非常具有臨床意義和重要的數據。我同意，是的。

Thanks very much.

非常感謝。

Thank you. Our next question comes from the line of Asuka Gunwarten from True Securities. The line's open.

謝謝。我們的下一個問題來自 True Securities 的 Asuka Gunwarten。線路已開通。

Hi, this is Karina for Asuka. Thanks for taking the question. Congrats on the progress. First one is when do you guys expect the Chinese and MPA label to be publicly available by PA for Harmony too, and, have you seen what the OS curves look like? And since it's now approved in China, can you tell if they show consistent or widening separation over time?

大家好，我是 Asuka 的 Karina。感謝您回答這個問題。恭喜你取得進展。第一個問題是，你們預期 PA 何時會為 Harmony 公開提供中文和 MPA 標籤，並且，你們看過 OS 曲線是什麼樣子的嗎？既然它現在已在中國獲得批准，您能否判斷它們隨著時間的推移是否表現出一致的分離或擴大的分離？

Hey Karina, this is Dave. I, so in terms of label being available from the NMPA, typically it's a little bit different in terms of how it works from the US perspective. It's it's not necessarily, published on the in the US case, the FDA website, so it becomes part of the next round of shipment in the, in the physical product is kind of the official update but it typically will be. Made available in a period of time shorter than that, but it's it's the short term aspect from that perspective. With respect, could you repeat your second question, Karina?

嘿，卡琳娜，我是戴夫。因此，就 NMPA 提供的標籤而言，與美國的觀點相比，其運作方式通常略有不同。它不一定在美國 FDA 網站上發布，因此它會成為下一輪發貨的一部分，在實體產品中是一種官方更新，但通常會如此。在比這更短的時間內就可以實現，但從這個角度來看，這只是短期現象。恕我直言，卡琳娜，您能重複您的第二個問題嗎？

Yeah, if you've seen the OS curves, what they look like and since it's already in China, can you tell like whether they're consistent or they're writing over time?

是的，如果你已經看到了操作系統曲線，它們是什麼樣子的，而且由於它已經在中國，你能判斷它們是否一致還是隨著時間的推移而變化嗎？

Yeah, and so similar to what I had mentioned before, this is Dave again, the trial was sponsored and conducted by our partners at Akeso, so we're going to allow them to release, the information with respect to To their clinical trials, so we, we're not going to get into the specifics of things that they haven't yet, disclosed publicly, but appreciate the interest and that would, likely come when they when they choose to disclose that what, it is medical meeting or otherwise.

是的，與我之前提到的類似，我是戴夫，這次試驗是由我們在康方生物的合作夥伴贊助和進行的，所以我們將允許他們發布有關他們的臨床試驗的信息，所以我們不會深入討論他們尚未公開披露的具體細節，但我們很感謝您的關注，而這很可能會在他們選擇披露信息時出現，無論是在醫學會議上還是在其他情況下。

And also one more on Harmony 3, have you guys had discussions with FDA about leveraging, Project Runner for approval?

另外關於 Harmony 3 的問題，你們是否與 FDA 討論利用 Project Runner 獲得批准的問題？

I didn't get, you cut out when you said project. Sorry, Karina, do you mind.

我沒明白，你說專案的時候就中斷了。抱歉，卡琳娜，你介意嗎？

(Repeating the I have bad service), project front runner and accelerated conditional filing.

（重複我的服務很差），專案領跑者和加速有條件申請。

So in general we don't typically get too far into our, discussions with the agency. We want to respect, what the agency, and we talk about in general we have had conversations with the agency multiple times with respect to Harmony 3, just to be clear, and we align, our trials based on feedback from the agency, but we don't necessarily want to get into, the individual details of the conversations per se, but I appreciate the question.

因此，一般來說，我們通常不會與該機構進行過多的討論。我們希望尊重該機構的意見，總的來說，我們已經就 Harmony 3 與該機構進行了多次對話，只是為了清楚起見，我們根據該機構的反饋調整我們的試驗，但我們不一定想深入討論對話本身的具體細節，但我很感謝這個問題。

Alright, thank you.

好的，謝謝。

Thank you. Our next question comes from the line of Mohit Bansal from Wells Fargo. The lines open.

謝謝。我們的下一個問題來自富國銀行的 Mohit Bansal。線路開通。

Great, thank you very much for taking my question and congrats on all the progress. I have two questions. I'll ask one by one. So regarding Harmony 2, is it fair to assume that the majority of the OS events would have happened only among the low PD1 patients given that (OS forkura) tends to be significantly longer for PD1 high patients and by extension (of ivonescimab).

太好了，非常感謝您回答我的問題，並祝賀您取得的所有進展。我有兩個問題。我一個一個問吧。因此，關於 Harmony 2，是否可以公平地假設大多數 OS 事件只會發生在低 PD1 患者中，因為（OS forkura）在 PD1 高患者中往往顯著更長，並且延伸而言（ivonescimab）。

Hey Mohit, this is Dave. I very much appreciate that question in the sense of, the expectation that you set there in your baseline, comment is true in the sense of the difference in the medians on the (femism outside), but at this point that becomes kind of a subgroup analysis piece and so again we'll defer to our partners at Akeso in terms of the timing of the detailed releases there.

嘿 Mohit，我是 Dave。我非常感謝你提出這個問題，因為你在基線中設定的期望，從中位數差異的意義上來說（女權主義之外），評論是正確的，但此時這成為一種亞群分析部分，因此，在詳細發佈時間方面，我們將再次聽從 Akeso 的合作夥伴的意見。

Got it. Okay, so let me ask you other one. Thank you. I appreciate that. So look, I mean, in the lung cancer, especially non-sponsor lung cancer, you're going after, an indication thatamro is pretty strong. Are there other indications where the delta for VAI PD1 combination could be much more pronounced versus a PD one inhibitor, where you know VAI could add a lot more value than than just lung cancer, and then where are you in terms of pursuing those indications outside of lung cancer? Thank you.

知道了。好的，那麼讓我問你另一個問題。謝謝。我很感激。所以，我的意思是，在肺癌，特別是非贊助商肺癌方面，你要追蹤的跡象表明 amro 非常強大。是否存在其他跡象表明 VAI PD1 組合的增量比 PD 單抑制劑更加明顯，您知道 VAI 可以增加比肺癌更多的價值，那麼在肺癌之外追求這些跡象方面您處於什麼位置？謝謝。

Things about, yeah, and I, and I'll take the first part of that, and then I'll hand it over to Alan for some details there, but I think I would, what I'd probably refer you to is the ESMO, 2024 phase two data, that was published by Akeso and so there are indications or or tumor settings, more appropriately there that, would not typically be, places where PD1 inhibitors in and of themselves have been particularly successful. Examples of that include microsatellite stable colorectal cancer, as well as the PDL1 low and negative, triple negative breast cancer, tumor settings, in terms of, the more specifics on.

是的，關於這一點，我將先談第一部分，然後交給艾倫，讓他提供一些細節，但我想我可能會推薦您參考 ESMO 的 2024 年第二階段數據，該數據由康方生物發布，因此有適應症或腫瘤環境，更確切地說，這些環境通常不會是 PD1 抑製劑本身特別成功的地方。例如微衛星穩定的大腸直腸癌，以及PDL1低且陰性、三陰性乳癌，就腫瘤設定而言，更具體。

Our our development plan, I think as Maky mentioned in the prepared remarks, we do plan on giving a little bit more context over the course of this year as opposed to kind of the individual, leaking out of or dripping of details, but I want to, we want to make sure we have the right alignment with the agencies and so on, but maybe biologically or whatnot, Alan, if you want to add any context to that.

我們的開發計劃，我想正如 Maky 在準備好的發言中提到的那樣，我們確實計劃在今年提供更多背景信息，而不是個別地洩露或透露細節，但我想，我們希望確保我們與各機構等保持正確的協調，但也許是生物學或其他方面，艾倫，如果你想添加任何背景信息的話。

Well, I think it's a good question. Again, we sort of boiled the ocean. We've looked at the PD1 approvals, we've looked at the bad Jeff approvals, and then there's clearly tumors where the bad Jeff and PD1 activity overlap, and we're looking at those, the things to consider about that is. What it would be the control arm for that study, what regions are those tumor types more prevalent in, and I think you can sort of, guess what I'm alluding to if you look at the specific tumor types.

嗯，我認為這是個好問題。我們再次將海洋煮沸。我們研究了 PD1 批准，也研究了糟糕的 Jeff 批准，然後顯然存在糟糕的 Jeff 和 PD1 活動重疊的腫瘤，我們正在研究這些，需要考慮的事情是。研究的對照組是什麼，這些腫瘤類型在哪些地區更為普遍，我想如果你看一下特定的腫瘤類型，你就能猜出我在暗示什麼。

And then what is the phase two data that capo generates. That's probably the most important thing and how we're thinking about which tumor types to go into next. So we do have a very clear plan of where we want to go next, and we're very excited about the IO data and all of those considerations, including the PD1 and VAF activity are taken into consideration.

那麼 capo 產生的第二階段資料是什麼呢？這可能是最重要的事情，以及我們如何思考下一步要研究哪種腫瘤類型。因此，我們確實對下一步的發展有一個非常明確的計劃，我們對 IO 數據感到非常興奮，並考慮到了所有這些因素，包括 PD1 和 VAF 活動。

I, I'm, I would just potentially add that in addition to specifically the vegF component. The cooperative binding is relevant here, that if we look at settings where we've demonstrated success, you have EGFR mutation positive. It's a setting, yes, where VF may be particularly relevant. It's also a setting where other PD1 inhibitors have not proven successful. You can also look at Harmony too and see that in The setting of high PDL1 where Pembro has been very favorable.

我，我，我可能會在具體添加 vegF 成分的同時添加它。協同結合在這裡是相關的，如果我們查看已證明成功的設置，則 EGFR 突變呈陽性。是的，這是一個 VF 可能特別相關的設定。這也是其他 PD1 抑制劑尚未證明成功的環境。您也可以看看 Harmony，看看在高 PDL1 設定中 Pembro 是否非常有利。

We also saw great success for Ivo relative to Pembro, but also see benefits for ivonescimab in the low PDL1 setting against Pembro, where Pembro has not been as commanding of a choice. And so I think that that can be extrapolated potentially into other settings, whether that is because specifically of the VegF component that it brings, but it also may be because Of the cooperative binding that may render ivonescimab a more effective immunotherapy.

我們也看到 Ivo 相對於 Pembro 取得了巨大的成功，但同時也看到 Ivonescimab 在低 PDL1 設定下優於 Pembro，而 Pembro 在該設定下並不是一個那麼突出的選擇。因此，我認為這可以推廣到其他環境中，無論是因為它帶來的 VegF 成分，還是因為協同結合可能使 ivonescimab 成為更有效的免疫療法。

Helpful. Thank you.

很有幫助。謝謝。

Thank you. Next question comes from Mitchell Kapoor from HG Wainwright. The line's open.

謝謝。下一個問題來自 HG Wainwright 的 Mitchell Kapoor。線路已開通。

Hey team, congrats on the recent progress and thank you for taking the questions. I wanted to ask, so the NMPA granted the first line of approval and PL1 positive non-small cell lung cancer patients in China based on Harmony II, but wanted to understand what it's going to take to get approval in the PDL1 low patients. Why didn't they grant this approval? Did they indicate anything like they need to see more data, or is that indicative of anything they're seeing in the Harmony II trial so far?

嘿，團隊，恭喜你們最近的進展，感謝你們回答問題。我想問一下，NMPA 是否根據 Harmony II 批准了中國一線治療和 PL1 陽性非小細胞肺癌患者的治療，但想了解在 PDL1 低患者中獲得批准需要什麼。他們為什麼不批准？他們是否表示需要查看更多數據，或者這是否表明了他們迄今為止在 Harmony II 試驗中看到的任何情況？

Hey Mitchell, it's Dave. I let me clarify that because I just want to make sure this is clear. So in, so we generally break down PDL one expression by negative, less than 1, low 1 to 49 or high. 50 plus and then in the case of Harmony two, when we say PDL1 positive, that was really 1 plus if you will, so the high and the low but not the negative.

嘿，米切爾，我是戴夫。我澄清一下，因為我只是想確保這一點清楚。因此，我們通常將 PDL 表達式分解為負數、小於 1、低 1 到 49 或高數。 50 加，然後在 Harmony two 的情況下，當我們說 PDL1 陽性時，如果你願意的話，那實際上是 1 加，所以有高和低，但不是負。

So the approval as we understand it in China from the NMPA was in PDL1 positive, so great PDL one expression, greater than 1, if you will, if you use the TPS scoring system. And so that is what the Harmony II trial was designed as PDL1 positive for Harmony 7, because of the standard of care in the Western markets, our trial is designed, it is a PDL1 high expressing patient population. I just want to clarify and make sure that it's clear mental.

因此，據我們了解，中國國家藥品監督管理局 (NMPA) 批准的 PDL1 是陽性的，因此，如果您使用 TPS 評分系統，那麼 PDL 的一個表達就大於 1。因此，Harmony II 試驗被設計為 Harmony 7 的 PDL1 陽性，因為西方市場的護理標準，我們的試驗是針對 PDL1 高表達患者群體而設計的。我只是想澄清一下並確保頭腦清晰。

Yeah thank you sorry so what I meant to to ask is the PDL1 negative, patients, is there, something that needs to be shown there that would be able to, gain approval in that population.

是的，謝謝，抱歉，我想問的是 PDL1 陰性患者，是否需要展示一些東西才能獲得該人群的認可。

So that wasn't part of the harmony to study, and so what would need to be shown there is is really a separate trial for lack of a better way of putting it. So the other thing that's important is if you look at the the Harmony six data that Akeso announced top line results for that is PDL1 all comers, so that would have the PDL1 negative for the less than 1% if you use the TPS score, and that's a chemo combination study, right? And so I think, and I'll hand this over to Jack to comment next, but if you look at the PDL1 negative population, you really, that's more of a chemo combination or something else akin to either our Harmony III squamous and non-squamous or a Akeso's Harmony six and squamous only.

所以這不是需要研究的和諧的一部分，因此需要證明的是，由於缺乏更好的表達方式，這實際上是一次單獨的試驗。因此，另一件重要的事情是，如果您查看 Akeso 宣布的 Harmony Six 數據，其頂線結果是 PDL1 全能者，因此，如果您使用 TPS 評分，那麼 PDL1 陰性的比例將不到 1%，這是一項化療組合研究，對嗎？所以我認為，接下來我會把這個問題交給傑克評論，但如果你看一下 PDL1 陰性人群，你會發現，這更像是一種化療組合，或者類似於我們的 Harmony III 鱗狀細胞和非鱗狀細胞或 Akeso 的 Harmony 六和鱗狀細胞的其他東西。

Yeah, thank you.

是的，謝謝。

Yeah, I just think that Dave articulated it very well. That's, Harmony two just doesn't speak to that population. It's not, clinically, and that's just not clinically what it would cover, but Harmony 6 as well as our own data Harmony three would and harmony, well, Harmony three in particular. Would be very relevant there. So that's just what it's going to take to be able to answer that question. Yeah.

是的，我認為戴夫表達得非常好。也就是說，Harmony 2 根本就不適合這個群體。從臨床上來說，這並不是它所涵蓋的臨床內容，但 Harmony 6 以及我們自己的資料 Harmony 3 將會，特別是 Harmony 3。將會非常相關。所以這就是回答這個問題所需要的。是的。

And this is Alan Mitchell. So just to be clear, there is some variability in what physicians do based on the PDL one expression levels, but to be clear, Harmony three and Harmony seven will cover the whole gamut of metastatic and advanced non-small cell lung cancer.

這是艾倫·米切爾。因此需要明確的是，醫生根據 PDL 一表達量所採取的措施存在一些差異，但需要明確的是，Harmony 三和 Harmony 七將涵蓋整個轉移性和晚期非小細胞肺癌。

Perfect thank you I appreciate that. And then last one for me just on the next update for Harmony two, are you able to just, appreciate the nominal alpha, but are you able to say if we'll be able to see P value, reported along with that nominal alpha level?

非常感謝，我很感激。然後最後一個問題，關於 Harmony 2 的下一次更新，您能否了解名義 alpha，但是您能否說我們是否能夠看到與名義 alpha 水平一起報告的 P 值？

Just to make sure I'm clear, Mitchell, you're asking when the next analysis would be or when the when the more detailed data for the NMPA requested analysis would be.

米切爾，為了確保我清楚，您問的是下一次分析是什麼時候，或者 NMPA 要求的分析的更詳細數據是什麼時候。

Sorry, yeah, so then basically the next overall survival, update, obviously you're 30%, the 39% data maturity, but at the next update, would we be able to see the p value in addition to that nominal alpha level, trying to search for statistical significance.

抱歉，是的，那麼基本上下一次總體生存率更新，顯然是 30%，數據成熟度是 39%，但在下一次更新時，除了名義 alpha 水平之外，我們是否還能夠看到 p 值，試圖尋找統計意義。

Yeah, I think what I would do, so a bit of that does come down to the choice by Akeso giving us their trial, but I think the the if you will, the next analysis would be more of the planned analysis in the intent so it would be more likely it would be more likely mature data, right? And and so you'd have a little bit more alpha spend that would come with that as well.

是的，我想我會怎麼做，這在一定程度上取決於康方生物給我們試驗的選擇，但我認為，如果你願意的話，下一次分析將更多的是計劃中的分析，所以它更有可能是成熟的數據，對嗎？因此，您還會有更多的 alpha 支出。

Got it. Thank you very much.

知道了。非常感謝。

Thank you. Our next question comes from the line of Eric Schmidt from Cancer Fitzgerald. The line's open.

謝謝。我們的下一個問題來自 Cancer Fitzgerald 的 Eric Sc​​hmidt。線路已開通。

Well, thank you for taking my questions. One on harmony and one on, harmony two. First on Harmony, when we see the data in mid 2025 on overall survival, will that OS result be a mature one, and what is required, via your conversations with the FDA around the US approval, either in terms of what you need to see with OS or PFS. In the Western population.

好的，感謝您回答我的問題。一是和諧，二是和諧。首先關於 Harmony，當我們在 2025 年中期看到總體生存率的數據時，OS 結果是否成熟，以及需要什麼，透過您與 FDA 就美國批准進行的對話，無論是就您需要看到的 OS 還是 PFS 而言。在西方人口中。

Yeah, I think Eric, this is Dave. I think what we had said earlier, I think I'll kind of stick to to that in terms of, we won't get into the explicit details back and forth of of the discussions, but, I'd remind you that we have, two primary end points and so I think it'll become a total package review irrespective of anything in terms of what the, decisions would be, but. Yeah, I think I'd leave it there.

是的，我認為埃里克，這是戴夫。我想，正如我們之前所說，我會堅持這一點，我們不會反覆討論具體的細節，但是，我要提醒你，我們有兩個主要終點，所以我認為無論做出什麼決定，它都會成為一個全面的一攬子審查。是的，我想我會把它留在那裡。

And they owe its maturity.

而這也歸功於它的成熟。

So yeah, we haven't commented on that, Eric. So what we've said is, and I think in McKee's prepared remarks they were, we will have data associated with with both primary endpoints, but in terms of the specifics on how much maturity on different points we haven't really disclosed that just yet. But we do getting data on both both end points.

是的，我們還沒有對此發表評論，埃里克。所以，我們已經說過，而且我認為在麥基準備好的發言中也提到過，我們將擁有與兩個主要終點相關的數據，但就不同點的成熟度具體情況而言，我們還沒有真正披露這一點。但我們確實在兩個端點都取得了數據。

Great, thank you for that. Second question on the harmony two HR that you've given 0.7777 of the pre-in term analysis, let's call it. I guess the number one question I get is whether with time that hazard ratio is likely to mature. In a favorable or unfavorable direction, do you have a view on that?

太好了，謝謝你。第二個問題是關於和諧二人力資源，您給了 0.7777 的學期前分析，我們稱之為。我想我遇到的第一個問題是，隨著時間的推移，風險比是否會成熟。從有利或不利的方向看，您對此有何看法？

Sure, so I think, and I, and I'll ask, Jack to comment on on this in terms of different trials, that he's seen as well, but. I, it a lower side of maturity, I think part of, from a statistical perspective is there's a little bit more variability that exists there, but I certainly wouldn't expect, there's only one direction it can go and I certainly what I wouldn't do in particular is I would not analogize from the Harmony A data that I think, occasionally we hear some chatter on with respect to, the initial NMPA request. Showed a 0.72 and then a follow up with 0.80 on on the OS there.

當然，所以我認為，我會請傑克根據他也見過的不同試驗對此發表評論，但是。我認為，從統計學角度來看，成熟度較低，部分原因是存在更多的可變性，但我當然不會期望，它只能朝一個方向發展，我當然不會特別做的是，我不會從 Harmony A 數據中進行類比，我認為，偶爾我們會聽到一些關於初始 NMPA 請求的閒聊。顯示 0.72，然後在 OS 上跟進 0.80。

There's some very clear differences between these trials second line versus first line, EGA positive, EGFR specifically versus non-driver mutation positive combination with chemotherapy versus monotherapy. So very important that, we've seen if we look at the PD1 inhibitors as a whole, if you will, for example, we've seen, movements up and, higher or lower in terms of more maturity, but I think, the point that we take here is that, this early on in the overall maturity to see a clinically meaningful, strongly positive trend is very encouraging from our perspective. Jack, any additional color that you'd add there?

在這些試驗中，二線治療與第一線治療、EGA 陽性治療、EGFR 陽性治療與非驅動突變陽性治療、化療合併治療與單一療法合併治療之間有非常明顯的差異。非常重要的是，如果我們從整體上看 PD1 抑制劑，我們會發現，隨著成熟度的提高，其價格有上漲也有下跌，但我認為，我們在這裡要強調的是，在整體成熟度的早期階段就看到具有臨床意義的、強烈的積極趨勢，從我們的角度來看，這是非常令人鼓舞的。傑克，你想在那裡添加任何其他顏色嗎？

I would add that speaking with clinicians extensively since the initial release, that, essentially that clinicians don't consider the OS to be as binary as that, especially so when it's in the setting of early preliminary data, but That recognizing that this is going against (embrolizumab), which is an extremely respected, comparator that has good activity.

我想補充一點，自首次發布以來，我與臨床醫生進行了廣泛的交談，基本上，臨床醫生並不認為 OS 是二元的，特別是在早期初步數據設定中，但他們認識到這與（embrolizumab）相悖，這是一種非常受人尊敬的、具有良好活性的比較器。

So, if you are seeing just a nominal, the hazard ratio of 0.78 or better, against against a comparator that is active and respected, without the, significant notable difference in toxicity, this is something that clinicians are absolutely welcoming and seeing in a very positive light, both for this particular setting and for what it may well represent outside of this particular test of monotherapy and PDL1 positive, but Just for given the the breadth of where pembrolizumab has historically been used in lung cancer and elsewhere, showing an improvement against that with a hazard ratio below 0.8, especially in a preliminary setting.

因此，如果您看到的只是名義上的，風險比為 0.78 或更高，與活性和受人尊敬的比較物相比，沒有顯著的毒性差異，這是臨床醫生絕對歡迎和非常積極看待的事情，無論是對於這種特定情況還是對於它在這種單一療法和 PDL1 陽性的特定測試之外可能代表的情況，但僅僅考慮到 pembrolumab 在應用肺癌和其他風險方面的風險範圍與其他風險比 0.的情況相比有所改善，特別是在初步環境。

It has really gotten people's notice and, they are not remotely deterred by the statistical issues or the preliminary nature. For where it is and where it should be, I think that the clinicians, by and large, are quite impressed and happy with that.

它確實引起了人們的注意，而且他們絲毫沒有被統計問題或初步性質所阻礙。對於它的現狀和應有的狀態，我認為臨床醫生總體上對此印象深刻並且感到滿意。

Very helpful. Thank you both.

非常有幫助。謝謝你們兩位。

Thank you. And our last question comes from the line of Wren Benjamin from Citizens, Line is open.

謝謝。我們的最後一個問題來自公民頻道的雷恩·本傑明 (Wren Benjamin)，熱線已開通。

Hey, good afternoon. Thanks for taking the questions. I guess one, in the Harmony study, is the (PFSNOS) going to be evaluated as a co-primary endpoint, or as Maky mentioned with Harmony three and seven dual endpoints, and can you remind us why, you would favor, let's say one over the other and and a more broader question, just given recent geopolitical tensions, can you Kind of give us your thoughts on how you're thinking about potential impact of tariffs, how you're thinking about manufacturing, and any IP and and API, based scenarios.

嘿，下午好。感謝您回答這些問題。我想，在 Harmony 研究中，（PFSNOS）是否會被評估為共同主要終點，或者正如 Maky 提到的 Harmony 三和七雙重終點，您能否提醒我們為什麼您會更喜歡其中一個，以及一個更廣泛的問題，鑑於最近的地緣政治緊張局勢，您能否告訴我們您對關稅和潛在影響的看法，您如何基於製造業，以及任何基於 IP 和 API 的情景。

Yeah, thanks, Wren. So for the first question, I think we look at it more as dual primary endpoints in terms of passing the alpha in hierarchical testing, PFS first and then OS with respect to the second question, I will hand that over to Manmeet to speak to.

是的，謝謝，Wren。因此，對於第一個問題，我認為我們更多地將其視為通過分層測試中的 alpha 的雙重主要終點，首先是 PFS，然後是 OS，至於第二個問題，我將把它交給 Manmeet 來談論。

Sure. Hi, this is Manmeet. On manufacturing front, as I mentioned earlier on the call, right, we already have. Have our current supply source from our partner Akeso, but in addition to that, we have made significant progress in starting our transferring the know-how to certain, CMOs, contract manufacturers in our territories, which is US and Europe, and other territories, which is continuing over there and, that that covers our concern on the manufacturing part.

當然。嗨，我是 Manmeet。在製造方面，正如我之前在電話中提到的，我們已經有了。我們目前的供應來源來自我們的合作夥伴康方生物，但除此之外，我們在開始將技術訣竅轉移給我們所在地區（美國、歐洲和其他地區）的某些 CMO、合約製造商方面取得了重大進展，這項工作還在繼續進行，這涵蓋了我們對製造部分的關注。

And in regard to IP as you mentioned, we have. Our IP continues until like late 2039, 2040s, right, so we have no concern even on the IP part and we believe pretty good on that, perspective too.

關於您所提到的智慧財產權，我們已經有。我們的 IP 將持續到 2039 年底或 2040 年代，對吧，所以我們甚至不必擔心 IP 部分，而且我們相信這方面前景也很好。

And just as a follow up, I mean the the manufacturing, from the CDMOs, will that product find its way into the Harmony 3 and Harmony 7 trials so that, upon potential approval, this is going to be quite kind of seamless in terms of the, utilizing the material or or will there need to be a bridging study? How do we think about that?

作為後續問題，我的意思是，從 CDMO 製造的產品是否會進入 Harmony 3 和 Harmony 7 試驗，以便在獲得潛在批准後，在利用材料方面這將是相當無縫的，或者是否需要進行橋接研究？我們對此有何看法？

No, it's like any, because every, I would say manufacturer or any pharma company will have multiple sources of production and we are also planning to add, right? Okay, so is one source we'll have another source from our contract manufacturers.

不，就像任何一家一樣，因為我想說每個製造商或任何製藥公司都會有多個生產來源，我們也計劃增加，對嗎？好的，這是一個來源，我們將從合約製造商那裡獲得另一個來源。

And you will have to do certain regulatory filings in order to not bridging studies but filings to compare the production batches and all those things and how they are comparing the batches with the specifications, and that would be required to do, done, and you know they obviously first would be to use them in clinical supplies, but those happen on a very regular basis for all the pharma companies.

您必須進行某些監管備案，以便不進行橋接研究，而是備案以比較生產批次和所有這些內容，以及如何將批次與規格進行比較，這是必須做的，而且您知道他們顯然首先會將它們用於臨床供應，但對於所有製藥公司來說，這些都會定期發生。

Great, thanks for taking the questions. Sure, thanks friend.

太好了，感謝您回答這些問題。當然，謝謝朋友。

Thank you. If there are no further questions, I return the call back over to Dave Genkars for final remarks.

謝謝。如果沒有其他問題，我會將電話轉回給 Dave Genkars 進行最後的評論。

Thank you, Justin and and thank you everyone for the amount of interesting questions. I think the last thing I'd like to do just you know to make sure we fully address is I'll hand it over to Jack West for, just given his extensive experience obviously in in thoracic oncology and whatnot any final comments, Jack that you have with respect to. The announcement with respect to the hazard ratio and the overall survival of the early look, for harmony two.

謝謝賈斯汀，也謝謝大家提出這麼多有趣的問題。我認為我最後要做的就是確保我們能完全解決這個問題，我將把這個時間交給傑克·韋斯特，鑑於他在胸部腫瘤學方面擁有豐富的經驗，傑克，請問您對此有什麼最後的評論。關於風險比和整體存活率的早期預測，結果為和諧二。

Yeah, I have had the opportunity over the last three to six months to have dozens and dozens of conversations with various thought leaders in thoracic oncology.

是的，在過去的三到六個月裡，我有機會與胸部腫瘤學領域的各種思想領袖進行了數十次對話。

Obviously, the, some of the biggest questions for Ivonescimab after, a great year last year was How does this look outside of China? We will see information about that, in the next several months, as well as, does the benefit hold up when added to chemo or how much does the addition of chemo to both arms kind of aggregate the difference? Harmony six is going to address that, and we already know that's in a favorable way, that that's not mitigated clearly, just it's not a phenomenon of monotherapy.

顯然，在經歷了去年的輝煌之後，Ivonescimab 面臨的最大疑問是，中國以外的市場前景如何？我們將在接下來的幾個月中看到有關這方面的信息，以及，當添加到化療中時，其益處是否仍然存在，或者在兩個治療組中添加化療會產生多大程度的差異？Harmony six 將解決這個問題，我們已經知道這是一種有利的方式，雖然這個問題並沒有得到明顯的緩解，但這並不是單一療法的現象。

And then the bigger question and we'll be able to speak to this somewhat with harmony and harmony too, now we have some insights about PFS to OS. That's always a question in lung cancer and other tumor types. It's always a question. With various, treatment approaches, but that's been a particular thorn in the side of VF inhibition, bevacizumab, and my colleagues and I have really thought about it, that regardless of that specific Pvalue associated, especially early and especially in a trial like Harmony two, that was not powered for overall survival.

然後是更大的問題，我們將能夠以和諧的方式談論這個問題，現在我們對 PFS 到 OS 有了一些見解。對於肺癌和其他類型的腫瘤來說，這始終是一個問題。這始終是一個問題。治療方法多種多樣，但 VF 抑制、貝伐單抗一直是個棘手問題，我和我的同事認真考慮過這個問題，無論相關的特定 P 值如何，尤其是在早期，尤其是在 Harmony two 這樣的試驗中，這都無法為總體生存率提供依據。

The key thing is that hazard ratio for OS after that PFS that we saw, is that going to be 0.7 something or 0.9 something? That's really exactly what I've been saying with them, and nobody knew until we saw that press release where that was, but it is in The 0.7 something range, and that is what people have been looking for, just to get a sense of, is this, does this track or does it not? And the answer is it absolutely does track.

關鍵在於我們看到 PFS 之後 OS 的風險比是 0.7 還是 0.9 左右？這正是我一直對他們說的，直到我們看到新聞稿才知道它在哪裡，但它在 0.7 左右的範圍內，這就是人們一直在尋找的，只是想了解一下，這是不是在跟踪它？答案是它確實可以追蹤。

So to me that That addresses that question and allays, some of those, many of those concerns, just so we'll get more details, but this in broad strokes was what we were hoping to clarify. If it gives it back or if it doesn't, of course, it's likely to erode somewhat with subsequent treatments, but I and my colleagues prospectively had been looking for 0.7 something is exactly what we've been hoping to see.

所以對我來說，這解決了這個問題，並緩解了其中的一些擔憂，這樣我們就能獲得更多細節，但總的來說，這正是我們希望澄清的。當然，如果它恢復原狀或沒有恢復，那麼在後續治療中它可能會減弱，但我和我的同事一直在尋找的 0.7 正是我們希望看到的。

Really appreciate it, Jack and I want to take the time to thank everybody for attending today's earnings call. We are unfortunately out of time now at this point, but, I want to say thank you and an archive version of the of this webcast will be available on our website www.smmttx.com. Thank you very much and enjoy your evening.

非常感謝，傑克和我想花點時間感謝大家參加今天的財報電話會議。不幸的是，我們現在已經沒有時間了，但是，我想說謝謝，這個網路廣播的存檔版本將在我們的網站 www.smmttx.com 上提供。非常感謝您，祝您晚上愉快。

The meeting has now concluded. Thank you all for joining. Have a pleasant day and you may now disconnect.

會議現已結束。感謝大家的加入。祝您有個愉快的一天，現在您可以斷開連線了。