Summit Therapeutics Inc (SMMT) 2023 Q1 法說會逐字稿

Good morning, and welcome to the Summit Therapeutics First Quarter 2023 Earnings and Update Call. (Operator Instructions) Please note that today's call is being recorded. (Operator Instructions)

早上好，歡迎來到 Summit Therapeutics 2023 年第一季度收益和更新電話會議。 （操作員說明）請注意，今天的通話正在錄音中。 （操作員說明）

At this time, I would like to introduce the call to Dave Gancarz, Senior Vice President of Stakeholder Relations, Business Development and Corporate Strategy. You may proceed.

此時，我想向利益相關者關係、業務發展和企業戰略高級副總裁 Dave Gancarz 介紹電話。你可以繼續。

Good morning, and thank you for joining us. Our press release was issued earlier this morning and is available on the home page of 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.

早上好，感謝您加入我們。我們的新聞稿於今天上午早些時候發布，可在我們網站的主頁上獲取。今天的電話會議正在同時進行網絡直播，今天晚些時候還將在我們的網站 www.smmttx.com 上提供存檔重播。

On the call with me today is Bob Duggan, our Chairman of the Board and Co-Chief Executive Officer; Dr. Maky Zanganeh, our Co-Chief Executive Officer and President; Ankur Dhingra, our Chief Financial Officer as well as Dr. Urte Gayko, our Head of Regulatory, Safety and Quality at Summit.

今天與我通電話的是我們的董事會主席兼聯席首席執行官 Bob Duggan；我們的聯席首席執行官兼總裁 Maky Zanganeh 博士；我們的首席財務官 Ankur Dhingra 以及 Summit 的監管、安全和質量主管 Urte Gayko 博士。

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

在我們開始之前，我想指出，我們的管理團隊所做的一些陳述以及我們今天對問題的一些回答可能被視為基於我們當前預期的前瞻性陳述。 Summit 警告說，這些前瞻性陳述受風險和不確定因素的影響，這些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存在重大差異。有關這些風險和不確定性的信息，請參閱我們向美國證券交易委員會提交的文件。除法律要求外，Summit 不承擔更新這些前瞻性陳述的義務。

Following comments from Bob, Maky and Ankur, we will take questions.

根據 Bob、Maky 和 Ankur 的意見，我們將接受提問。

With that, I will turn the call over to Bob.

有了這個，我會把電話轉給鮑勃。

Thank you, Dave. It's a pleasure to be on the call with each of you this morning. I'm incredibly proud of the accomplishments of Team Summit over the past few months since we closed our transaction with the world-class partners at Akeso. Our relationship discussions with Akeso began in July of 2022 through our business development channels. By October, we had achieved a vision and a concept of what a partnership with Akeso, including their bispecific drug, ivonescimab, could potentially generate under Team Summit's stewardship. Throughout November, we gained additional data and evaluated it properly on not only the company, but the product itself.

謝謝你，戴夫。很高興今天早上能和你們每個人通電話。自從我們與 Akeso 的世界級合作夥伴完成交易以來，過去幾個月 Team Summit 取得的成就讓我感到無比自豪。我們與康方生物的關係討論始於 2022 年 7 月，通過我們的業務發展渠道。到 10 月，我們已經實現了與 Akeso 合作的願景和概念，包括他們的雙特異性藥物 ivonescimab，在 Team Summit 的管理下可能產生什麼。整個 11 月，我們獲得了額外的數據，並不僅對公司而且對產品本身進行了適當的評估。

As we gained additional direct experience with Akeso's team leadership and specifically with Dr. Michelle Xia, Akeso's CEO, founder and Chairwoman, we were able to then lead on to a December 5 truly historic day and transaction for all of us. We signed a $5 billion and $500 million upfront transaction with Akeso. By entering into this transaction, we committed to our stakeholders consistent with our mission statement to take full responsibility for the development of ivonescimab along with that we intend -- stated that we intended to make a significant positive difference for human health care by improving the quality of patient lives and potentially the duration of patient lives for most patients who may benefit from this medicine. I'm proud to say that we are making significant strides towards fulfilling that commitment. And Maky will provide us with additional details shortly regarding our progress on that.

隨著我們在 Akeso 的團隊領導，特別是與 Akeso 的首席執行官、創始人兼董事長 Michelle Xia 博士的合作中獲得了額外的直接經驗，我們得以在 12 月 5 日為我們所有人帶來真正具有歷史意義的一天和交易。我們與康方生物簽署了 50 億美元和 5 億美元的預付款交易。通過進行這項交易，我們向我們的利益相關者承諾與我們的使命宣言一致，對 ivonescimab 的開發以及我們打算承擔全部責任 - 聲明我們打算通過提高質量為人類醫療保健帶來重大積極影響對於可能受益於該藥物的大多數患者，患者的生命和潛在的患者生命持續時間。我很自豪地說，我們正在朝著履行這一承諾邁出重要的一步。 Maky 將很快向我們提供有關我們在這方面取得的進展的更多詳細信息。

Finally, from a corporate governance perspective, we are proud to have added Dr. Michelle Xia to our Board of Directors this quarter in conjunction with closing Akeso transaction. As you may know, but it's worth repeating, if you do, Dr. Xia, who founded Akeso in 2012, is their Chairwoman and CEO. She has exceptional experience in leadership across scientific discovery, R&D, building and scaling manufacturing and overall leadership through her experience at companies in the U.S., including Celera Genomics, Bayer and Crown Bioscience. At Crown, she played a decisive role in constructing the company's platform as she served in a leadership role in a joint venture with Pfizer. Dr. Xia has about 20 years of experience in the pharmaceutical industry and academic research in the U.S. and U.K., in addition to her deep experience in leading the Chinese company, Akeso.

最後，從公司治理的角度來看，我們很自豪能夠在本季度完成 Akeso 交易的同時將 Michelle Xia 博士加入我們的董事會。如您所知，但值得重申的是，如果您知道，2012 年創立 Akeso 的夏博士是他們的董事長兼首席執行官。她在科學發現、研發、建造和擴大製造以及全面領導方面擁有非凡的領導經驗，她曾在美國公司工作，包括 Celera Genomics、拜耳和 Crown Bioscience。在 Crown，她在與輝瑞的合資企業中擔任領導職務，在構建公司平台方面發揮了決定性作用。夏博士在美國和英國擁有約 20 年的製藥行業和學術研究經驗，此外還擁有領導中國公司 Akeso 的豐富經驗。

And with that, I would like to hand it over to Maky to provide additional context as to our accomplishments and next steps. Maky?

因此，我想將其交給 Maky，以提供有關我們的成就和後續步驟的更多背景信息。馬基？

Thank you, Bob, and good morning, everyone. I'm incredibly enthusiastic about our collaboration with Akeso. Akeso has a rich and diversified antibody drug pipeline with over 30 internally discovered drug candidates in various stages of development, including 6 bispecific antibodies. Akeso has taken part in over 80 clinical trials for 17 drug candidates, including 14 pivotal trials. Akeso has 2 drugs approved for oncology indication in China, a PD-1 inhibitor and a novel PD-1/CTLA-4 bispecific antibody called cadonilimab. Cadonilimab is the first PD-1-based bispecific antibody approved in any major market, demonstrating Akeso expertise and innovation in this space.

謝謝鮑勃，大家早上好。我對我們與 Akeso 的合作充滿熱情。康方生物擁有豐富且多元化的抗體藥物管線，擁有超過30個處於不同開發階段的內部發現候選藥物，其中包括6個雙特異性抗體。康方生物參與了17個候選藥物的80多項臨床試驗，其中包括14項關鍵試驗。康方康方有兩種藥物在中國獲批用於腫瘤適應症，一種是 PD-1 抑製劑，一種是新型 PD-1/CTLA-4 雙特異性抗體卡多尼單抗。 Cadonilimab 是第一個在任何主要市場獲得批准的基於 PD-1 的雙特異性抗體，展示了康方生物在該領域的專業知識和創新。

Akeso has over 2,400 employees who perform end-to-end functions of a fully integrated biopharma company from drug discovery through to manufacturing and commercialization, and is publicly listed in Hong Kong with a valuation approaching USD 5 billion. Specific to our product candidate, ivonescimab is an innovative, potentially first-in-class bispecific antibody that is intended to change the standard of care across several oncological indications.

Akeso 擁有超過 2,400 名員工，他們在一家完全整合的生物製藥公司執行從藥物發現到製造和商業化的端到端職能，並在香港公開上市，估值接近 50 億美元。具體到我們的候選產品，ivonescimab 是一種創新的、潛在一流的雙特異性抗體，旨在改變多種腫瘤適應症的護理標準。

Ivonescimab combines the effect of immunotherapy via a blockade of PD-1 with anti-angiogenesis effects associated with VEGF into a single molecule. Anti-PD-1 therapy assists the immune system in killing tumor cells. Anti-VEGF therapy helps deplete the tumor of new blood vessels and allows the immune system to fight the tumor.

Ivonescimab 將通過阻斷 PD-1 的免疫治療效果與與 VEGF 相關的抗血管生成效果結合到一個分子中。抗 PD-1 療法有助於免疫系統殺死腫瘤細胞。抗 VEGF 療法有助於耗盡腫瘤的新生血管，並讓免疫系統對抗腫瘤。

Ivonescimab's tetravalent structures enables higher avidity, which is the accumulated strength of multiple binding interactions with over 10x the binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells. This tetravalent structure, the design of the molecule and bringing these 2 targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which could lead to reduced adverse events associated with this target when administered individually. It also has the potential to focus the antitumor activity of both targets as compared to separate anti-PD-1 and anti-VEGF compounds dosed together.

Ivonescimab 的四價結構可實現更高的親合力，這是在體外腫瘤細胞中存在 VEGF 的情況下，多重結合相互作用的累積強度，與 PD-1 的結合親和力超過 10 倍。這種四價結構、分子設計以及將這 2 個靶標帶入單一雙特異性抗體中，有可能將 ivonescimab 引導至腫瘤組織而不是健康組織，這可能導致單獨給藥時與該靶標相關的不良事件減少。與一起給藥的單獨抗 PD-1 和抗 VEGF 化合物相比，它還有可能集中兩個靶標的抗腫瘤活性。

As Bob said, I'm extremely proud of the work and accomplishment of Team Summit over the past several months since we have reached an agreement with Akeso. We began our work formulating our ideas on the development of ivonescimab during our due diligence process in the second half of last year. Once we signed the deal in December and the agreement went effective in January, we have pushed very hard on bringing to life the vision that we set out at the start of this collaboration. We immediately engaged with health authorities in our licensed territories, including the U.S. FDA. We held multiple meetings with the FDA to discuss multiple Phase III clinical trials as part of our late-stage development plan in a non-small cell lung cancer for ivonescimab.

正如 Bob 所說，自從我們與 Akeso 達成協議以來，我對 Team Summit 在過去幾個月的工作和成就感到非常自豪。我們在去年下半年的盡職調查過程中開始製定我們關於 ivonescimab 開發的想法。在我們於 12 月簽署協議並於 1 月生效後，我們一直在努力實現我們在合作開始時設定的願景。我們立即與我們許可地區的衛生當局接洽，包括美國 FDA。我們與 FDA 舉行了多次會議，討論多項 III 期臨床試驗，作為我們針對 ivonescimab 的非小細胞肺癌後期開發計劃的一部分。

We appreciated and incorporated feedback from the FDA when finalizing the design of our 2 clinical studies, which we announced last week. They are ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic nonsquamous non-small cell lung cancer who have progressed after treatment with a third-generation EGFR TKI, such as osimertinib, which we refer to as the HARMONi trial.

在完成我們上周宣布的 2 項臨床研究的設計時，我們感謝並採納了 FDA 的反饋。它們是 ivonescimab 聯合化療用於 EGFR 突變、局部晚期或轉移性非鱗狀非小細胞肺癌患者，這些患者在使用第三代 EGFR TKI（例如奧希替尼）治療後出現進展，我們稱之為 HARMONi 試驗。

The second trial, ivonescimab, combined with chemotherapy in first-line metastatic squamous non-small cell lung cancer patients, which we call the HARMONi-3 trial. This study will combine patients enrolled in China, along with patients enrolled in the United States, Canada and Europe as a multiregional randomized, double-blind study enrolling over 400 patients across these regions.

第二項試驗是 ivonescimab 聯合化療治療一線轉移性鱗狀非小細胞肺癌患者，我們稱之為 HARMONi-3 試驗。這項研究將把在中國登記的患者與在美國、加拿大和歐洲登記的患者結合起來，作為一項多區域隨機雙盲研究，在這些地區招募 400 多名患者。

In supporting these clinical trials, we are executing up in a number of different areas including the work to begin clinical trials with different trial sites and vendors such as preparing clinical study sites to enroll patients and all of the foundational work needed to launch a clinical study including contracts, institutional review board approvals and quality reviews.

為了支持這些臨床試驗，我們正在許多不同的領域開展工作，包括與不同的試驗地點和供應商開始臨床試驗的工作，例如準備臨床研究地點以招募患者以及開展臨床研究所需的所有基礎工作包括合同、機構審查委員會的批准和質量審查。

Critical to all of this is the engagement with key opinion leaders and aligning feedback from this highly engaged physicians with the data generated from Akeso, having treated over 750 patients with ivonescimab to date in China and Australia in order to successfully generate the momentum needed to enroll each study as effectively and efficiently as possible.

所有這一切的關鍵是與主要意見領袖的接觸，並將這些高度參與的醫生的反饋與 Akeso 產生的數據保持一致，迄今為止，Akeso 已在中國和澳大利亞治療了 750 多名 ivonescimab 患者，以成功產生註冊所需的勢頭盡可能有效和高效地進行每項研究。

In addition to preparing clinical drug supply for trials in our territory, we have been actively preparing to expand our supply chain channel long term with respect to having the opportunity to obtain clinical and commercial supply for multiple sources. Because of the hard work and effort across our entire team and the support from our partner at Akeso, we have initiated our first clinical study in our territory HARMONi. We were thrilled to announce earlier this week that we have enrolled our first patient in the HARMONi study, a feat accomplished in about 3.5 months after our deal closed with Akeso. We are following up for the achievement with our intent to initiate HARMONi-3 and enroll patients in this study in the second half of this year.

除了準備在境內進行試驗的臨床藥物供應外，我們一直在積極準備長期擴展我們的供應鏈渠道，以期有機會獲得多來源的臨床和商業供應。由於我們整個團隊的辛勤工作和努力以及我們在 Akeso 的合作夥伴的支持，我們已經在我們的領土 HARMONi 啟動了我們的第一個臨床研究。本週早些時候，我們很高興地宣布，我們已經在 HARMONi 研究中招募了第一位患者，這是在我們與 Akeso 的交易結束後約 3.5 個月內完成的一項壯舉。我們正在跟進這一成就，我們打算在今年下半年啟動 HARMONi-3 並在這項研究中招募患者。

As we have stated since the announcement of the deal in conjunction with our actions and following through of our commitments to start in a non-small cell lung cancer. These 2 clinical trials are only the first step with respect to our plans for ivonescimab. We have confidence in ivonescimab to continue to expand both with an additional indication in non-small cell lung cancer and in other solid tumors during its development life cycle. Our deal was constructed with this mindset as is evident from the number of indications for which regulatory milestones are scheduled to be paid as well as the size of the potential milestone. We believe strongly in the potential of ivonescimab.

正如我們在宣布該交易以及我們的行動和履行我們從非小細胞肺癌開始的承諾以來所說的那樣。這兩項臨床試驗只是我們 ivonescimab 計劃的第一步。我們對 ivonescimab 有信心在其開發生命週期中繼續擴展非小細胞肺癌和其他實體瘤的額外適應症。我們的交易是以這種心態構建的，從計劃支付監管里程碑的跡像數量以及潛在里程碑的規模可以明顯看出。我們堅信 ivonescimab 的潛力。

As a reminder, our collaboration and license agreement provide us with the rights to ivonescimab in the United States, Canada, Europe and Japan. In exchange for these rights, we paid $500 million upfront to Akeso. And Akeso is eligible to receive regulatory milestone of to $1.05 billion and commercialization milestone of up to $3.45 billion. Akeso will receive low double-digit royalty on all net sales of SMT112. We continue to build up and establish actions and data created by Akeso and the deal we have consummated.

提醒一下，我們的合作和許可協議為我們提供了在美國、加拿大、歐洲和日本使用 ivonescimab 的權利。為了換取這些權利，我們向康方生物預付了 5 億美元。 Akeso 有資格獲得高達 10.5 億美元的監管里程碑和高達 34.5 億美元的商業化里程碑。 Akeso 將從 SMT112 的所有淨銷售額中獲得低兩位數的特許權使用費。我們繼續建立和建立 Akeso 創建的行動和數據以及我們已經完成的交易。

Our team has made multiple visits to Akeso in the past few months and spent meaningful time in person with Akeso leadership over the past 8 months in order to continue to build the success of Akeso earlier-stage clinical trials and propel our collaboration to the next level as we continue to work together to achieve the best results and realize the potential of ivonescimab. Our aligned missions each of which focus on patients' needs and improve patient lives allow for allowing intention within our partnership and the future of ivonescimab.

我們的團隊在過去幾個月裡多次訪問康方生物，並在過去 8 個月裡與康方生物的領導層一起度過了有意義的時光，以繼續推動康方生物早期臨床試驗的成功，並推動我們的合作更上一層樓隨著我們繼續共同努力以取得最佳結果並實現 ivonescimab 的潛力。我們一致的使命中的每一個都側重於患者的需求和改善患者的生活，這使得我們的合作夥伴關係和 ivonescimab 的未來成為可能。

My confidence cannot be higher in Team Summit's ability to make a meaningful impact on the lives of patients who can benefit from this innovative therapy, both in non-small cell lung cancer and other solid tumors. This is just the beginning.

我對 Team Summit 能夠對受益於這種創新療法的非小細胞肺癌和其他實體瘤患者的生活產生有意義的影響充滿信心。這僅僅是個開始。

Now I will let Ankur give some more details on our financial position and outlook.

現在我將讓 Ankur 詳細介紹我們的財務狀況和前景。

Thank you, Maky. These are very exciting times at Summit. With ivonescimab, we have a great opportunity in front of us to improve patients' lives, and I'm very pleased with the progress that team has made in this short duration of time.

謝謝你，馬基。在峰會上，這是非常激動人心的時刻。有了 ivonescimab，我們就有了一個改善患者生活的好機會，我對團隊在這麼短的時間內取得的進展感到非常高興。

I will now give you an update on the financial developments during the quarter and our financial position as of the end of the quarter. During the quarter, we completed significant purchasing and financing transactions. First, we completed the in-licensing deal with Akeso and paid them $500 million as upfront consideration. This was paid via approximately $475 million in cash and 10 million shares of Summit's common stock. Second, we successfully completed our rights offering of $500 million. This offering was oversubscribed with broad-based participation.

我現在將向您介紹本季度的財務發展情況以及我們截至本季度末的財務狀況。本季度，我們完成了重大採購和融資交易。首先，我們完成了與 Akeso 的許可協議，並向他們支付了 5 億美元作為前期對價。這是通過大約 4.75 億美元現金和 1000 萬股 Summit 普通股支付的。其次，我們成功完成了 5 億美元的配股。此次發行獲得了廣泛參與的超額認購。

Third, we repaid $420 million of the loans this quarter, and are left with $100 million of loan on our balance sheet, which becomes due in September 2024. Fourth, we announced that we are ceasing investment in our anti-infectives business, focusing our resources on development of ivonescimab. And most importantly, we did all the foundational work that Maky described towards initiation of 2 Phase III clinical trials. It's been a busy quarter.

第三，我們本季度償還了 4.2 億美元的貸款，資產負債表上還有 1 億美元的貸款，將於 2024 年 9 月到期。第四，我們宣布停止對我們的抗感染業務的投資，將重點放在我們的ivonescimab 開發資源。最重要的是，我們完成了 Maky 描述的所有基礎工作，以啟動 2 項 III 期臨床試驗。這是一個繁忙的季度。

Now about the P&L. Net loss for the quarter was $542.4 million, included therein is $520.9 million of IP R&D expenses, which reflects the upfront payment made to Akeso for in-licensing of ivonescimab, comprising of $474.9 million in cash payment and 10 million shares issued to Akeso with accounting valuation of $45 million reflecting market price on the date the shares were issued. Excluding this onetime payment, pro forma net loss was about $22 million, of which our operating expenses were $16.8 million.

現在關於損益表。本季度淨虧損為 5.424 億美元，其中包括 5.209 億美元的 IP 研發費用，反映了向 Akeso 支付的 ivonescimab 引進許可預付款，包括 4.749 億美元的現金付款和向 Akeso 發行的 1000 萬股會計核算4500 萬美元的估值反映了股票發行之日的市場價格。除去這筆一次性付款，預計淨虧損約為 2200 萬美元，其中我們的運營費用為 1680 萬美元。

Talking about our cash position. We exited the quarter with $242 million in cash and investments. We believe this is sufficient to fund our operating cost and working capital needs for currently planned clinical trials for SMT112 going into the second half of 2024. This includes appropriately building an experienced oncology team capable of executing multiple large clinical trials and the related development work. We have a loan of $100 million on our balance sheet that becomes due on September 2024 and have ability to prepay in certain scenarios if we complete a capital raise transaction prior to September 2024.

談論我們的現金狀況。我們以 2.42 億美元的現金和投資退出了本季度。我們相信這足以滿足我們目前計劃的 SMT112臨床試驗的運營成本和營運資金需求，這些試驗將在 2024 年下半年進行。這包括適當建立一支經驗豐富的腫瘤學團隊，能夠執行多項大型臨床試驗和相關開發工作。我們的資產負債表上有一筆 1 億美元的貸款，將於 2024 年 9 月到期，如果我們在 2024 年 9 月之前完成融資交易，我們有能力在某些情況下提前還款。

Also to note, all our cash equivalents and investments are held in highly liquid and highly rated money market funds or U.S. treasuries and the cash is held in large U.S. and European banks. To sum up, in last few months, we've taken significant actions since closing the deal for the in-licensing of ivonescimab, a significant amount of groundwork leading to announcement of 2 late-stage multi-region trials and treatment of first patient in our first trial. We also laid a solid financial foundation for investment in our planned clinical studies and the development of ivonescimab.

另請注意，我們所有的現金等價物和投資都持有高流動性和高評級的貨幣市場基金或美國國債，並且現金持有美國和歐洲的大型銀行。總而言之，在過去幾個月裡，自完成 ivonescimab 的許可交易以來，我們採取了重大行動，大量的基礎工作導致宣布了 2 項後期多區域試驗和第一名患者的治療我們的第一次審判。我們還為投資我們計劃中的臨床研究和開發 ivonescimab 奠定了堅實的財務基礎。

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 Ankur. We can now transition if there are any questions that we could answer. If we could please open the line for questions.

謝謝 Bob、Maky 和 Ankur。如果有任何我們可以回答的問題，我們現在可以過渡。如果可以，請打開問題熱線。

(Operator Instructions)

（操作員說明）

Thank you, Kayla. And we have received a couple of questions first. So I'll start with those questions, and then we can transition to those on the phone.

謝謝你，凱拉。我們首先收到了幾個問題。所以我將從這些問題開始，然後我們可以過渡到電話上的問題。

The first question comes in relates to the Phase III clinical trials that we plan to conduct, and whether or not we will be able to submit any data that has been compiled and generated by Akeso as opposed to just that data that has been generated by Summit.

第一個問題涉及我們計劃進行的 III 期臨床試驗，以及我們是否能夠提交任何由康方生物編譯和生成的數據，而不僅僅是 Summit 生成的數據.

So I'll take the first part of that question, then I'll hand it over to Urte, who's our Head of Regulatory, Safety and Quality. So our HARMONi trial will enroll patients in the United States, Canada, Europe and China. Those patients coming from China will be enrolled by our partners at Akeso. So our intent is to include data that is generated by our partners at Akeso specifically for this trial.

所以我會回答這個問題的第一部分，然後我會把它交給我們的監管、安全和質量主管 Urte。因此，我們的 HARMONi 試驗將在美國、加拿大、歐洲和中國招募患者。這些來自中國的患者將由我們在 Akeso 的合作夥伴招募。因此，我們的目的是包括我們在 Akeso 的合作夥伴專門為該試驗生成的數據。

Yes. This is Urte Gayko. Yes, we will definitely be able to utilize information coming from both Akeso side as well as the data that we are generating. The most important part for the [registration] is that we have appropriately designed -- [aligned] trials with the important health authority for the U.S., obviously, the FDA in the context of multiregional studies. We have actually discussed exactly how to do this appropriately for our Phase III studies and have given an agreement on that, specifically with FDA and are executing in this context.

是的。這是烏爾特·蓋科。是的，我們肯定能夠利用來自康方方面的信息以及我們正在生成的數據。 [註冊] 最重要的部分是我們已經適當地設計 - [對齊] 與美國重要衛生當局的試驗，顯然是 FDA 在多區域研究的背景下。我們實際上已經討論瞭如何為我們的 III 期研究適當地做到這一點，並就此達成協議，特別是與 FDA 達成協議，並在這種情況下執行。

Thank you, Urte. And one additional question that we've received. With respect to certain designations from the FDA, such as breakthrough therapy designation, Fast Track designation what can the company do in order to seek to achieve those designations if they're appropriate?

謝謝你，烏爾特。我們還收到了另一個問題。關於 FDA 的某些指定，例如突破性療法指定、快速通道指定，公司可以做些什麼來尋求獲得這些指定（如果合適）？

So I think both of these designations are of interest and likely relevant for ivonescimab. So Fast Track first. So I think we are a strong candidate for Fast Track, and are likely to pursue this designation. We have also started as it relates to breakthrough designation consultation with FDA specifically what kind of data set would be most appropriate to pursue that designation. And we will continue this consultation with FDA. So both of them are very relevant for us, and we are likely candidates.

所以我認為這兩個名稱都很有趣，並且可能與 ivonescimab 相關。首先是快速通道。所以我認為我們是 Fast Track 的有力候選者，並且很可能追求這一稱號。我們也已經開始，因為它涉及與 FDA 的突破性指定諮詢，特別是哪種數據集最適合追求該指定。我們將繼續與 FDA 進行磋商。所以他們兩個都對我們很重要，我們很可能是候選人。

Kayla, any additional questions?

凱拉，還有其他問題嗎？

(Operator Instructions)

（操作員說明）

And there are no audio questions at this time. Dave, I'll turn the call back to you.

目前沒有音頻問題。戴夫，我會把電話轉給你。

Perfect. Thank you very much. I would like to thank you for your participation in this. And with that, they will be an archived version of this webcast that will be available on our website, www.smmttx.com. Thank you, and we wish you a great day.

完美的。非常感謝。感謝您的參與。因此，它們將成為該網絡廣播的存檔版本，可在我們的網站 www.smmttx.com 上獲取。謝謝你，我們祝你有美好的一天。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。