Summit Therapeutics Inc (SMMT) 2023 Q3 法說會逐字稿

Good morning, and welcome to the Summit Therapeutics third quarter 2023 earnings and update call. (Operator Instructions) Please note that today's call is being recorded. At this time, I would like to introduce the call to Dave Gancarz, Chief Business and Strategy Officer. You may proceed.

早安，歡迎參加 Summit Therapeutics 2023 年第三季財報和更新電話會議。 （操作員說明）請注意，今天的通話正在錄音。現在，我想向首席業務和策略長 Dave Gancarz 介紹這次通話。您可以繼續。

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

感謝您加入我們。我們的新聞稿於今天早上早些時候發布，可在我們網站的主頁上找到。我們的 10-Q 表格也在今天早上提交，可在我們的網站上取得。今天的電話會議同時進行網路直播，存檔重播將於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 Chief Executive Officer; Dr. Maky Zanganeh, our Chief Executive Officer and President; Ankur Dhingra, our Chief Financial Officer; Dr. Allen Yang, our Chief Medical Officer. And in addition, we are joined by our new Chief Operating Officer, Manmeet Soni.

今天和我一起參加電話會議的是我們的董事會主席兼執行長鮑勃杜根 (Bob Duggan)； Maky Zanganeh 博士，我們的執行長兼總裁； Ankur Dhingra，我們的財務長；楊艾倫博士，我們的首席醫療官。此外，新任營運長 Manmeet Soni 也加入了我們的行列。

Manmeet joins us from Reata Pharmaceuticals where he was the President, Chief Operating Officer, and Chief Financial Officer. Reata was recently purchased by Biogen for approximately $7.5 billion. Manmeet was previously the CFO at Alnylam Pharmaceuticals and ARIAD Pharmaceuticals. Before that, he was the CFO of Pharmacyclics. Manmeet will continue to serve on our Board and he also serves on the Board of Pulse Biosciences. Manmeet will be responsible for all commercial activities, finance, clinical operations, manufacturing, legal, information technology, and human resources. In conjunction with Manmeet joining us, he invested $5 million in the company in a private placement of market rates.

Manmeet 在加入我們之前曾在 Reata Pharmaceuticals 擔任總裁、營運長兼財務長。 Reata 最近被 Biogen 以約 75 億美元的價格收購。 Manmeet 先前曾擔任 Alnylam Pharmaceuticals 和 ARIAD Pharmaceuticals 的財務長。在此之前，他曾擔任 Pharmacyclos 的財務長。 Manmeet 將繼續在我們的董事會任職，他也擔任 Pulse Biosciences 的董事會成員。 Manmeet 將負責所有商業活動、財務、臨床營運、製造、法律、資訊科技和人力資源。在 Manmeet 加入我們的同時，他以市場利率私募方式向該公司投資了 500 萬美元。

We are excited to have Manmeet join team Summit, and let's welcome Manmeet to the team.

我們很高興 Manmeet 加入 Summit 團隊，並歡迎 Manmeet 加入團隊。

Thanks, Dave. I'm very excited to be here and be part of team Summit. I worked with the team here at Summit for the last four years as a Board member, and I'm very thrilled to join as a member of the very accomplished and committed management team. I strongly believe that our pipeline candidate, ivonescimab, with the two Phase III clinical trials, currently enrolling in the United States, Canada, Europe, and China, has the potential to bring a paradigm shift in the standard of care for patients with solid tumors starting with non-small cell lung cancer. I'm fully committed to our mission of developing new, innovative, and patient-friendly medicines for unmet medical needs. And I'm excited to contribute to making this positive meaningful difference.

謝謝，戴夫。我很高興來到這裡並成為 Summit 團隊的一員。過去四年，我作為董事會成員與 Summit 團隊一起工作，我很高興能夠作為非常有成就和忠誠的管理團隊的一員加入。我堅信，我們的候選藥物 ivonescimab 擁有兩項 III 期臨床試驗，目前正在美國、加拿大、歐洲和中國進行招募，有可能為實體瘤患者的護理標準帶來範式轉變從非小細胞肺癌開始。我完全致力於我們的使命，即開發新的、創新的、對病人友善的藥物，以滿足未滿足的醫療需求。我很高興能為這種積極而有意義的改變做出貢獻。

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

謝謝，曼梅特。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提出的問題的一些答复可能被視為基於我們當前預期的前瞻性聲明。請注意，這些前瞻性陳述存在風險和不確定性，可能導致實際結果與前瞻性陳述中所示的結果有重大差異。請參閱我們向 SEC 提交的文件，以了解有關這些風險和不確定性的資訊。除法律要求外，Summit 不承擔更新這些前瞻性聲明的義務。

Following comments from Bob, Maky, and Ankur, we will take questions. With that, I will turn the call over to Bob.

根據 Bob、Maky 和 ​​Ankur 的評論，我們將回答問題。這樣，我會將電話轉給鮑伯。

Thank you, Dave. Good morning, everyone, and thank you for joining us today. I'd like to say a few words about what team Summit has accomplished. But I will hand it over to Maky to add more color, and then Ankur will provide some updates regarding our financial position and current outlook.

謝謝你，戴夫。大家早安，感謝您今天加入我們。我想簡單談談 Summit 團隊所取得的成就。但我會將其交給 Maky 來添加更多色彩，然後 Ankur 將提供一些有關我們財務狀況和當前前景的最新資訊。

I'm very proud of the efforts and accomplishments of team Summit since we have entered into our very fruitful partnership with Akeso. As we announced this morning, we have begun enrolling in our second Phase III clinical trial, HARMONi-3, in frontline population of patients suffering from squamous cell carcinoma of the lung. This is our second Phase III non-small cell lung cancer trial that is designed with registrational intent. We have accomplished this based on and driven by conviction in our belief in ivonescimab.

自從我們與康方生物建立富有成效的合作關係以來，我對 Summit 團隊的努力和成就感到非常自豪。正如我們今天早上宣布的那樣，我們已開始在患有肺鱗狀細胞癌的一線患者中招募第二項 III 期臨床試驗 HARMONi-3。這是我們第二個以註冊為目的的 III 期非小細胞肺癌試驗。我們之所以能夠實現這一目標，是基於我們對 ivonescimab 的信念。

In just nine months since we have closed our deal to in-license ivonescimab, we have achieved these milestones with intent of helping patients who need continuous innovation to improve quality of life and potential duration of life, consistent with our mission at Summit. Dedication to our mission and collapsing time when and where possible has provided Maky and me, along with our team, with success in the past. Whether in networking technology, robotic surgery, or with ibrutinib in the case of Pharmacyclics, once again, we are committed to making a positive difference for patient betterment in the area of solid tumors.

自從我們完成 ivonescimab 許可交易以來的短短九個月內，我們就實現了這些里程碑，旨在幫助需要持續創新的患者提高生活品質和潛在壽命，這與我們在 Summit 上的使命一致。過去，對我們的使命的奉獻和在可能的情況下的崩潰時間為 Maky 和我以及我們的團隊帶來了成功。無論是在網路技術、機器人手術，還是在 Pharmacyclos 中使用依魯替尼，我們再次致力於為實體瘤領域的患者改善做出積極的改變。

I'm also very proud of the organization that we have -- that we continue to strengthen at team Summit. Highlighting this is the decision of Manmeet Soni to join as full-time as our Chief Operating Officer. Manmeet is a seasoned executive with an excellent track record of success, as Dave highlighted earlier. He has also been a Board member and trusted adviser of the company since 2019. An executive of the caliber of Manmeet joining our company and believing in our mission and pipeline, in addition to his personal investment, validates the confidence we have in our intention to make a significant, positive difference to those patients who can benefit most from the work we are doing.

我也為我們擁有的組織感到非常自豪——我們在團隊高峰會上繼續加強這個組織。 Manmeet Soni 決定加入我們並擔任全職營運官，這一點凸顯了這一點。正如戴夫之前所強調的那樣，曼米特是一位經驗豐富的高管，擁有出色的成功記錄。自2019 年以來，他一直是公司的董事會成員和值得信賴的顧問。像Manmeet 這樣的高管加入我們公司，除了他的個人投資之外，他還相信我們的使命和管道，這證實了我們對我們的意圖的信心。為那些可以從我們所做的工作中受益最多的患者帶來重大、積極的影響。

Also, in consideration of the accomplishments we have had as an organization, we've also elevated a number of specific members of our management team. Fong Clow is our new Chief Biometrics Officer. Dave Gancarz is now our Chief Business and Strategy Officer. Urte Gayko is our Chief Regulatory, Quality, and Safety Officer. And Allen Yang is now our Chief Medical Officer. This team works tirelessly to advance Summit, along with each of the leaders and team members that comprise our team.

此外，考慮到我們作為一個組織所取得的成就，我們也提升了管理團隊中的一些特定成員。 Fong Clow 是我們新任首席生物辨識官。戴夫·甘卡茲 (Dave Gancarz) 現任我們的首席業務和策略長。 Urte Gayko 是我們的首席監管、品質和安全官。楊艾倫現在是我們的首席醫療官。團隊與我們團隊的每一位領導者和團隊成員一起，孜孜不倦地努力推進高峰會。

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

至此，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資訊。麥基？

Thank you, Bob, and good morning, everyone. I'm incredibly enthusiastic about ivonescimab, its potential, and what team Summit has already accomplished. As Bob said, with true conviction and purpose, along with our belief in ivonescimab, to have accomplished our mission to benefit patients facing difficult odds with unmet medical need, comes the incredible power of execution of team Summit at speeds accomplished by fields if any, in the biotech space.

謝謝你，鮑勃，大家早安。我對 ivonescimab、它的潛力以及 Summit 團隊已經取得的成就充滿熱情。正如鮑伯所說，帶著真正的信念和目標，以及我們對ivonescimab 的信念，完成我們的使命，造福那些面臨困難且醫療需求未得到滿足的患者，峰會團隊以領域完成的速度（如果有的話）令人難以置信的執行力，在生物技術領域。

We now have two actively enrolling Phase III clinical trials for ivonescimab. Our first trial is for those patients with non-small cell lung cancer harboring EGFR mutations who have progressed following a third generation TKI, such as Tagrisso. We began enrolling patients in the second quarter of this year, and we can now state that we intend to complete enrollment in the second half of 2024. As we have committed to along our tenure here at Summit, we worked tirelessly to collapse time in order to achieve our aggressive but realistic goals.

我們現在有兩項正在積極招募 ivonescimab 的 III 期臨床試驗。我們的第一個試驗是針對那些攜帶 EGFR 突變的非小細胞肺癌患者，這些患者在接受第三代 TKI（例如 Tagrisso）後病情進展。我們從今年第二季度開始招募患者，現在我們可以宣布，我們打算在 2024 年下半年完成招募。正如我們在 Summit 任職期間所承諾的那樣，我們不知疲倦地工作，以縮短時間，以便實現我們積極但現實的目標。

Our second Phase III clinical trial for ivonescimab is in frontline therapy. Those two have not yet received treatment for patients with squamous cell carcinoma of the lung. We will enroll patients in this trial across North America, Europe, and China. That trial is designed to compare ivonescimab and chemotherapy against Keytruda and chemotherapy in order to determine the efficacy and safety of our innovative bispecific antibody in this setting.

我們針對 ivonescimab 的第二項 III 期臨床試驗正在進行第一線治療。這兩個人尚未接受肺鱗狀細胞癌患者的治療。我們將在北美、歐洲和中國招募患者參加這項試驗。該試驗旨在將 ivonescimab 和化療與 Keytruda 和化療進行比較，以確定我們創新的雙特異性抗體在這種情況下的有效性和安全性。

Our convention to move forward with all appropriate speed has been in place since we worked through our due diligence, ivonescimab with Akeso. Obviously, our upfront payment of $500 million to Akeso spoke volumes about our conviction and belief in ivonescimab. Disclosed in part at ASCO 2023, the large data set that Akeso has generated backs up our conviction of how ivonescimab plus chemotherapy performed in Phase II clinical trials supports our decision to quickly pursue a registrational Phase III study. We believe that this study data is very promising when compared to the current standard of care, Keytruda plus chemotherapy, and supports our decision to directly move forward into first-line therapy with our second Phase III clinical trial.

自從我們與康方生物進行盡職調查以來，我們就以適當的速度向前推進的約定已經到位。顯然，我們向康方生物支付的 5 億美元預付款充分說明了我們對 ivonescimab 的信念和信念。在 ASCO 2023 上部分揭露的康方生物生成的大數據支持了我們對 ivonescimab 聯合化療在 II 期臨床試驗中的表現的信念，支持我們快速開展註冊 III 期研究的決定。我們相信，與目前的護理標準（Keytruda 加化療）相比，這項研究數據非常有希望，並支持我們透過第二個 III 期臨床試驗直接進入第一線治療的決定。

In collaboration with our partners at Akeso, we published a poster further describing the mechanism of action of ivonescimab at the 38th Annual Meeting of the Society of Immunotherapy of Cancer, SITC 2023, one of the premium conferences of the year.

我們與康方生物的合作夥伴合作，在年度頂級會議之一的癌症免疫治療學會第 38 屆年會 SITC 2023 上發布了一張海報，進一步描述了 ivonescimab 的作用機制。

Ivonescimab is not designed to be the same as the sequential administration of an anti-PD-1 and then an anti-VEGF. Ivonescimab is an innovative, potentially first-in-class bispecific antibody that builds on this to establish cancer targets. Ivonescimab tetravalent structure enables cooperative binding between PD-1 and VEGF. Our poster at Citi 2023 describes that the binding of ivonescimab to PD-1 is actually over 18 times stronger in the presence of VEGF in vitro. In addition, its binding affinity to VEGF is over fourfolds stronger in the presence of PD-1 in vitro.

Ivonescimab 的設計目的與依序施用抗 PD-1 然後抗 VEGF 不同。 Ivonescimab 是一種創新的、潛在的一流雙特異性抗體，以此為基礎建立癌症標靶。 Ivonescimab 四價結構能夠實現 PD-1 和 VEGF 之間的協同結合。我們在花旗 2023 上的海報描述，在體外 VEGF 存在的情況下，ivonescimab 與 PD-1 的結合實際上強 18 倍以上。此外，在體外有 PD-1 的情況下，與 VEGF 的結合親和力強四倍以上。

Importantly, there is potentially higher expression or presence --

重要的是，有可能有更高的表達或存在——

Thank you, ladies and gentlemen. We apologize for the technical issues. I'll hand it back over to Maky to continue with her comments. Maky?

謝謝你們，女士們、先生們。對於技術問題，我們深表歉意。我會將其交還給 Maky 繼續她的評論。麥基？

Thank you, Dave. Continue up on -- ivonescimab is not designed to be the same as the sequential administration of an anti-PD-1 and then an anti-VEGF. Ivonescimab is an innovative, potentially first-in-class bispecific antibody that builds on these to establish cancer targets. Ivonescimab tetravalent structure enables cooperative binding between PD-1 and VEGF. Our poster at Citi 2023 describe that the binding of ivonescimab to the PD-1 is actually over 18 times stronger in the presence of VEGF in vitro. In addition, its binding affinity to VEGF is over fourfolds stronger in the presence of PD-1 in vitro.

謝謝你，戴夫。繼續--ivonescimab 的設計目的與順序施用抗 PD-1 然後抗 VEGF 不同。 Ivonescimab 是一種創新的、潛在的一流雙特異性抗體，以這些抗體為基礎來建立癌症標靶。 Ivonescimab 四價結構能夠實現 PD-1 和 VEGF 之間的協同結合。我們在花旗 2023 上的海報描述，在體外 VEGF 存在的情況下，ivonescimab 與 PD-1 的結合實際上強 18 倍以上。此外，在體外有 PD-1 的情況下，與 VEGF 的結合親和力強四倍以上。

Importantly, there is potentially higher expression or presence of both PD-1 and VEGF in tumor tissue and the tumor microenvironment, the area around the tumor, as compared to normal tissue in the body. The tetravalent structure, the intentional novel design of the molecule and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue.

重要的是，與體內正常組織相比，腫瘤組織和腫瘤微環境（腫瘤周圍區域）中 PD-1 和 VEGF 的表達或存在可能更高。四價結構、分子的有意新穎設計以及將這兩個標靶引入具有協同結合質量的單一雙特異性抗體中，有可能將 ivonescimab 導向腫瘤組織而不是健康組織。

Anti-PD-1 therapy assists the immune system in killing tumor cells by attaching to the part of a T cell that actually prevent the T cell from doing its job in the first place. Some cancer tumor cells take advantage of the built-in checkpoint on the T cell that is intended to prevent the immune system from overreacting. Anti-PD-1 therapy seek to bind to PD-1 on the T cell, allowing the T cell to do its job without a checkpoint or break. Hence, it's referred to as a checkpoint inhibitor.

抗 PD-1 療法透過附著到 T 細胞的一部分來幫助免疫系統殺死腫瘤細胞，而該部分實際上從一開始就阻止了 T 細胞發揮作用。一些癌症腫瘤細胞利用 T 細胞上的內建檢查點，旨在防止免疫系統過度反應。抗 PD-1 療法尋求與 T 細胞上的 PD-1 結合，使 T 細胞能夠在沒有檢查點或中斷的情況下完成其工作。因此，它被稱為檢查點抑制劑。

Anti-VEGF therapy helps deplete the tumor of nutritions and blood by binding to VEGF. VEGF helps build new blood cells to supply blood to the tumor. Anti-VEGF therapy also allows the immune system to better fight the tumor. We believe ivonescimab goes further that the sequential administration of anti-PD-1 and anti-VEGF through this cooperative binding mechanism we just described. The intent, the stronger ability in this design is to improve upon previously established efficacy standards in addition to the side effects and safety profile associated with these two targets. Ivonescimab was designed such that the novel compound is greater than just the sum of its parts.

抗 VEGF 療法可透過與 VEGF 結合幫助消耗腫瘤的營養和血液。 VEGF 有助於產生新的血球，為腫瘤提供血液。抗 VEGF 療法還可以讓免疫系統更好地對抗腫瘤。我們相信 ivonescimab 進一步透過我們剛才描述的這種協同結合機制順序施用抗 PD-1 和抗 VEGF。設計的目的是，除了與這兩個目標相關的副作用和安全性之外，還可以改善先前製定的功效標準。 Ivonescimab 的設計使得新型化合物的效果大於其各個部分的總和。

Our plans to continue to expand our clinical development programs remain in place. Non-small cell lung cancer is only the first step. We have confidence in ivonescimab to continue to expand both in additional indications in non-small cell lung cancer and in other solid tumors during its development life cycle. Our aggregate with Akeso was drawn up with this mindset. We believe strongly in the potential of ivonescimab.

我們繼續擴大臨床開發項目的計劃仍然有效。非小細胞肺癌只是第一步。我們對 ivonescimab 在其開發生命週期中繼續擴大非小細胞肺癌和其他實體瘤的其他適應症充滿信心。我們與康方生物的合作就是基於這種心態而製定的。我們堅信 ivonescimab 的潛力。

We have begun accepting requests for investigator-sponsored trials, IST programs. As we continue to broaden our message related to ivonescimab with the key opinion leaders, as well as other physician leaders. We appreciate their high level of enthusiasm for what ivonescimab can do in and outside of lung cancer. We have received multiple inquiries related to potential IST programs that we are considering. And we expect to share additional information in 2024.

我們已開始接受研究者資助的試驗（IST 計畫）的請求。隨著我們繼續與關鍵意見領袖以及其他醫生領袖擴大有關 ivonescimab 的資訊。我們感謝他們對 ivonescimab 在肺癌內外的作用的高度熱情。我們收到了多個與我們正在考慮的潛在 IST 專案相關的詢問。我們預計在 2024 年分享更多資訊。

Finally, I would like to say a word about our team. Based on the accomplishments of team Summit over the last couple of years, we have elevated certain members of our management team. I congratulate Dave, Urte, Fong, and Allen in their well-deserved new roles.

最後，我想談談我們的團隊。基於過去幾年高峰會團隊的成就，我們提升了管理團隊的某些成員。我祝賀 Dave、Urte、Fong 和 Allen 當之無愧的新角色。

I'm also very excited, we have been able to attract outstanding physicians to complete our clinical development leadership team, Dr. Jack West and Dr. Laura Chow, have each joined us over the past months. They have over 45 years of combined experience as practicing medical oncologist as well as substantial experience in the development of cancer treatments that now represents some of the most significant cancer therapies in present time. Dr. Jack West is a renowned lung cancer expert, and Dr. Laura Chow is a trailblazer in a novel immunotherapies and anti-angiogenic treatments, primarily focused in lung cancer, as well as head and neck cancer.

我也非常興奮，我們已經能夠吸引優秀的醫生來完善我們的臨床開發領導團隊，Jack West 博士和 Laura Chow 博士在過去幾個月中分別加入了我們。他們作為執業腫瘤科醫生擁有超過 45 年的綜合經驗，並且在癌症治療方法的開發方面擁有豐富的經驗，這些治療方法現在代表了當今一些最重要的癌症治療方法。 Jack West 博士是著名的肺癌專家，Laura Chow 博士是新型免疫療法和抗血管生成療法的開拓者，主要專注於肺癌以及頭頸癌。

Team Summit is a truly special place and I would like to thank each member of our amazing team for their dedication to our mission and goals. Now, I will ask Ankur to provide additional details on our financial position and outlook. Ankur?

團隊高峰會是一個真正特別的地方，我要感謝我們出色團隊的每位成員對我們使命和目標的奉獻。現在，我將要求 Ankur 提供有關我們財務狀況和前景的更多詳細資訊。安庫爾？

Thank you, Maky. Really pleased with the progress, both in the development of ivonescimab and continued build-out of team Summit. We believe ivonescimab has excellent potential and continue to build our development plans towards realizing that. I will give you an update on the financial developments and position, as well as financial outlook for the upcoming quarter.

謝謝你，麥基。對 ivonescimab 的開發和 Summit 團隊的持續建設所取得的進展感到非常滿意。我們相信 ivonescimab 具有巨大的潛力，並將繼續制定我們的開發計劃以實現這一目標。我將為您提供有關財務發展和狀況的最新信息，以及下一季度的財務前景。

Regarding the P&L, majority of our spending is in research and development focused on development of ivonescimab. We spent $15.2 million in R&D this quarter. As mentioned, we have engaged in two global Phase III clinical trials for ivonescimab, both of which are enrolling and treating patients. We're also investing in technology plans for manufacturing of ivonescimab in our territories.

關於損益表，我們的大部分支出用於專注於 ivonescimab 開發的研發。本季我們的研發支出為 1520 萬美元。如前所述，我們已經進行了兩項 ivonescimab 的全球 III 期臨床試驗，兩項試驗均正在招募和治療患者。我們還投資了在我們的領土上生產 ivonescimab 的技術計劃。

We spent $5.4 million in general administration expenses during the quarter, focused on providing infrastructure and leadership for our development efforts. We expect this quarterly run rate of spending to continue to increase next quarter, as well as in 2024, as we scale both pivotal studies, adding sites, and treating patients, as well as continuing to build our team. Similarly, investment in manufacturing capabilities will continue to increase the next several quarters. At the same time, we continue to ensure that we remain disciplined in our approach of investment to extend our cash run rate as long as possible.

本季我們花了 540 萬美元的一般管理費用，重點是為我們的開發工作提供基礎設施和領導力。我們預計，隨著我們擴大關鍵研究、增加研究地點、治療患者以及繼續建立我們的團隊，下季度以及 2024 年這一季度的支出將繼續增加。同樣，對製造能力的投資將在未來幾季繼續增加。同時，我們繼續確保我們的投資方法保持紀律，以盡可能延長我們的現金運行率。

With respect to our cash position, we exited the quarter with $200.5 million in cash, investments, and receivables. We have a loan of $100 million that matures in September 2024. This loan has provided us significant non-dilutive capital, enabling a strong foundation for development of ivonescimab, while initiation of two pivotal clinical trials. Our cash position is sufficient to continue to make significant progress in the development of ivonescimab by funding the operating costs and working capital needs for HARMONi and HARMONi preclinical trials going into September 2024.

就我們的現金狀況而言，本季結束時我們擁有 2.005 億美元的現金、投資和應收帳款。我們有一筆 1 億美元的貸款，將於 2024 年 9 月到期。這筆貸款為我們提供了大量的非稀釋資本，為 ivonescimab 的開發奠定了堅實的基礎，同時啟動了兩項關鍵臨床試驗。我們的現金狀況足以透過為 2024 年 9 月開始的 HARMONi 和 HARMONi 臨床前試驗的營運成本和營運資金需求提供資金，繼續在 ivonescimab 的開發方面取得重大進展。

As mentioned before, we continue to hold our cash equivalents and these investments in highly liquid and highly rated money market funds for the US treasuries. And all the money has been reputable with US and European banks.

如前所述，我們繼續持有現金等價物以及對美國國債的高流動性和高評級貨幣市場基金的投資。所有的資金在美國和歐洲的銀行中都享有盛譽。

And with that, I'll 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 to see if there are any questions from anyone on the line that we can answer. If you can please open the line for questions.

謝謝鮑伯、麥基和安庫爾。現在，我們可以進行切換，看看是否有任何在線人員提出的問題我們可以回答。如果可以的話，請打開提問熱線。

(Operator Instructions) Brad Canino, Stifel.

（操作員說明）Brad Canino，Stifel。

Hi. Good morning, team. And thank you for hosting the call and taking the question. This has been a really busy quarter of external Phase III data disclosures and the tumor types for which you're developing ivonescimab. I'm thinking specifically of the data in EGFR-mutant lung from amivantamab, and then some of the TROP-2 ADCs broadly, in the later line setting, it's been known that those will be investigated early on frontline soon. It would be great to hear your view of this evolving competitive landscape and the opportunities that remain for ivonescimab. Thank you.

你好。早上好，團隊。感謝您主持電話會議並回答問題。這是一個非常繁忙的季度，外部 III 期數據披露以及你們正在開發的 ivonescimab 的腫瘤類型。我特別想到的是阿米萬他單抗的 EGFR 突變肺中的數據，然後是一些廣泛的 TROP-2 ADC，在後期的生產線設置中，眾所周知，這些數據很快就會在前線進行早期研究。很高興聽到您對不斷變化的競爭格局以及 ivonescimab 仍然存在的機會的看法。謝謝。

Yeah. I don't think it really changes too much our landscape. We're well underway in our Phase III program for these EGFR refractory patients. If you look at the FLAURA2 data, it was really looking at the frontline setting, and I don't think that really changes our landscape per se. And then I think you're talking about the MARIPOSA-2 data as well. What we think about osimertinib is that it is the standard of care for frontline EGFR-mutant lung cancer. But for those patients who relapse, we think that this is a great opportunity. And we know that there's good data for ivonescimab in this space. If you look back, there is a failure of PD-1 in this space, if you look at pembro and nivo. However, there was the ORIENT-31 study that looked at PD-1 and bevacizumab biosimilar and that study was positive.

是的。我認為這並沒有真正改變我們的景觀太多。我們針對這些 EGFR 難治性患者的 III 期計畫正在順利進行中。如果你看一下 FLAURA2 的數據，它實際上是在關注前線環境，我認為這並沒有真正改變我們的景觀本身。我認為您也在談論 MARIPOSA-2 數據。我們對奧希替尼的看法是，它是一線 EGFR 突變肺癌的治療標準。但對於那些復發的患者來說，我們認為這是一個很好的機會。我們知道該領域有關於 ivonescimab 的良好數據。如果你回顧過去，如果你看看 pembro 和 nivo，你會發現 PD-1 在這個領域失敗了。然而，ORIENT-31 研究著眼於 PD-1 和貝伐珠單抗生物相似藥，該研究是積極的。

Getting to Rybrevant, what we've heard from our engagement with experts is that it is somewhat difficult to give. And so, we don't believe that will be significant competition. In addition, the EGFR refractory spaces are fast-to-market strategy and then we're also simultaneously conducting a large front-line study in squamous non-small cell lung cancer.

說到 Rybrevant，我們從與專家的接觸中了解到，提供起來有些困難。因此，我們認為這不會是一場重大競爭。此外，EGFR難治性空間是快速上市策略，然後我們也同時進行鱗狀非小細胞肺癌的大型第一線研究。

Brad, do you have any follow-up to that?

布拉德，你有什麼後續行動嗎？

That's it for me. Thank you so much.

對我來說就是這樣。太感謝了。

Thank you, Brad. Appreciate your questions.

謝謝你，布拉德。感謝您的提問。

There are no further questions at this time. I will now turn the call over to Dave Gancarz for closing remarks.

目前沒有其他問題。現在我將把電話轉給戴夫甘卡茲 (Dave Gancarz) 致閉幕詞。

Thank you, Cheryl. And we have received a couple of questions from our current shareholders that I'd like to address as well. And so, one of the questions relates to how clinical trials have progressed with respect to Akeso in China and Australia. And so, at this point in time, I'd like to address that piece, and I'll hand it over to Allen for any additional points, but Akeso has 23 clinical trials at this point, did it either been started or have completed at this point from Phase I through Phase III. We've treated over 950 patients with ivonescimab in their clinical trials, including the placebo arm having or the active control arm have included well over 1,000 patients.

謝謝你，謝麗爾。我們收到了當前股東提出的幾個問題，我也想回答一下。因此，問題之一是康方生物在中國和澳洲的臨床試驗進展如何。所以，在這個時候，我想解決這個問題，我會把它交給 Allen 來補充任何問題，但是康方生物目前有 23 項臨床試驗，它是否已經開始或已經完成至此，從第一階段到第三階段。我們在臨床試驗中使用 ivonescimab 治療了超過 950 名患者，其中安慰劑組或活性對照組已包括超過 1,000 名患者。

This significant experience building up with respect to ivonescimab, in particular in one of the settings they will -- Akeso will be looking to achieve approval in China in 2024 in the EGFR-mutant setting, in addition to continuing in multiple Phase III settings in China and Australia. So that data is continuing to grow and that growing dataset continues to give us confidence in our progression with our clinical development plan as well.

在ivonescimab 方面累積的這一重要經驗，特別是在他們將要進行的一項試驗中——除了繼續在中國進行多個III 期試驗之外，康方生物還將尋求2024 年在中國的EGFR 突變試驗中獲得批准和澳大利亞。因此，數據正在持續成長，不斷增長的數據集也繼續讓我們對臨床開發計劃的進展充滿信心。

Yeah. The only thing that I would say is that this is a very unique molecule. Maybe I can spend some time, this past weekend at SITC, there was a press releases that Maky related earlier around the mechanism of action. So, we do target PD-1. PD-1, PD-L1 are well-validated targets. PD-1, of course, seems to be more popular. Ivonescimab is a bispecific in the sense that targets both PD-1 and VEGF. Now there are other strategies targeting PD-L1 and VEGF, but I believe there is a difference. And there was data released this past ASCO for both either ivonescimab and a series of PD-L1 VEGFs.

是的。我唯一要說的是，這是一個非常獨特的分子。也許我可以花一些時間，上週末在 SITC，Maky 早些時候發布了一份關於作用機制的新聞稿。所以，我們的目標是 PD-1。 PD-1、PD-L1 是經過充分驗證的標靶。當然，PD-1似乎更受歡迎。 Ivonescimab 是一種雙特異性藥物，同時針對 PD-1 和 VEGF。現在還有其他針對 PD-L1 和 VEGF 的策略，但我相信是有區別的。去年 ASCO 發布了 ivonescimab 和一系列 PD-L1 VEGF 的數據。

Now ivonescimab is also unique. Besides targeting two validated targets, PD-1 and VEGF, as Maky alluded to earlier, there's cooperative binding. The binding of PD-1 increases VEGF by fourfold, and the binding of VEGF increases PD-1 binding by 18-fold. And so theoretically, what you're going to have is the tightest binding in a location where both antigens exists, which is the tumor microenvironment.

現在 ivonescimab 也是獨一無二的。正如 Maky 之前提到的，除了針對兩個經過驗證的標靶 PD-1 和 VEGF 之外，還有協同結合。 PD-1 的結合使 VEGF 增加四倍，而 VEGF 的結合使 PD-1 結合增加 18 倍。因此從理論上講，在兩種抗原都存在的位置（即腫瘤微環境）中，您將獲得最緊密的結合。

Now the other thing to think about is that ivonescimab is a tetravalent molecule. So that's two binding sites for PD-1 and two binding sites VEGF. VEGF is a secreted dimer by the tumors. And because of that, it can lead to potential cross-linking of two ivonescimab molecules, and actually multiply ivonescimab molecules. This is well described in the literature for bevacizumab. And we believe the same thing is happening for ivonescimab. And that actually leads to a possibility of an increased avidity.

現在要考慮的另一件事是 ivonescimab 是一種四價分子。這是 PD-1 的兩個結合位點和 VEGF 的兩個結合位點。 VEGF 是腫瘤分泌的二聚體。正因為如此，它可以導致兩個 ivonescimab 分子潛在的交聯，並實際上使 ivonescimab 分子倍增。關於貝伐珠單抗的文獻對此進行了詳細描述。我們相信同樣的事情也發生在 ivonescimab 身上。這實際上可能會增加熱情。

So there's affinity, the tighter binding between the cooperative binding, but then there's a possibility for avidity as well. So the easiest way to think about this is if you think about one hand holding a handlebar with a tight grip, using two hands to hold that bar with both hands, that's the affinity phenomenon. So there's a tighter binding for affinity and a tighter binding for avidity as well. And so, we believe that this will have important differences in giving -- as opposed to giving both of these agents separately. And the clinical data seems to support that and we're moving very aggressively forward.

因此，存在親和力，合作結合之間的結合更緊密，但也有可能產生親和力。因此，最簡單的思考方法是，如果你想像一隻手緊緊握住車把，用兩隻手握住車把，這就是親和力現象。因此，親和力有更緊密的結合，親和力也有更緊密的結合。因此，我們相信這在給予方面將有重要的區別——與分別給予這兩種藥物不同。臨床數據似乎支持這一點，我們正在非常積極地向前邁進。

Thank you, Allen. And I think you've mainly address this. And then another question with respect to how does this differentiate from just a PD-1 agent on its own. So a lot of approved PD-1 agents exist, pembrolizumab, durvalumab, but if you can just kind of speak to a little bit the difference there in terms of how it works.

謝謝你，艾倫。我認為你主要解決了這個問題。另一個問題是它與單獨的 PD-1 藥物有何區別。因此，有許多已批准的 PD-1 藥物，例如 pembrolizumab、durvalumab，但如果您能稍微談談它們在工作原理方面的差異。

Yeah. I thought I described that pretty well. But if you want more detail, we could talk about the three-hour answers but I'll try to give a 30-second answer here. Maybe focusing on the MOA, where we have both an affinity and avidity sort of phenomenon playing off with ivonescimab, we've been moving very aggressively based on the clinical trial data. If you look at all the PD-1s, and less so the PD-L1s out there, they've pretty much done the same thing. They've gone into non-small cell lung cancer. They compare themselves to chemotherapy. We believe that ivonescimab is superior to PD-1 and PD-L1 therapy. Okay?

是的。我認為我描述得很好。但如果你想了解更多細節，我們可以討論三個小時的答案，但我會嘗試在這裡給出一個 30 秒的答案。也許專注於 MOA，我們在 MOA 上與 ivonescimab 產生了一種親和力和親和力的現象，我們一直在根據臨床試驗數據非常積極地採取行動。如果您查看所有 PD-1，尤其是 PD-L1，您會發現它們幾乎做了相同的事情。他們已經患上了非小細胞肺癌。他們將自己與化療進行比較。我們相信 ivonescimab 優於 PD-1 和 PD-L1 治療。好的？

To prove that, there are four Phase IIIs running. Two global ones that are being conducted by Summit and then two Chinese specific studies that are being run by Akeso. The partnerships, you've heard about the HARMONi and HARMONi-3 in EGFR progressors and frontline squamous non-small cell lung cancer, these are ones we're conducting globally with our partners, Akeso, in China. But Akeso actually has, as Dave alluded to, a treasure trove of data across multiple different tumor types, and they've advanced into two additional Phase IIIs that are China-specific. One is called the 306 study, which is a front-line squamous cell non-small cell lung cancer against tislelizumab the BeiGene PD-1 for their market. So it's a Chinese specific squamous cell front-line study. But they're also running a frontline study of monotherapy ivonescimab against pembrolizumab in front-line non-small cell lung cancer.

為了證明這一點，有四個三期專案正在運行。峰會正在進行兩項全球研究，康方生物正在進行兩項針對中國的研究。您已經聽說過 HARMONi 和 HARMONi-3 治療 EGFR 進展細胞和一線鱗狀非小細胞肺癌的合作夥伴關係，這些是我們與中國合作夥伴康方生物在全球範圍內開展的合作夥伴關係。但正如戴夫所提到的，康方生物實際上擁有跨越多種不同腫瘤類型的數據寶庫，並且他們已經進入了另外兩個針對中國的 III 期臨床試驗。其中一項稱為 306 研究，這是針對其市場的百濟神州 PD-1 替雷利珠單抗的一線鱗狀細胞非小細胞肺癌研究。所以這是一項針對中國人的鱗狀細胞一線研究。但他們也正在進行一項針對第一線非小細胞肺癌單一療法 ivonescimab 與 pembrolizumab 的第一線研究。

So if you look at the four studies we're conducting, three of them are against PD-1 and two of them are specifically against pembrolizumab or Keytruda. So we are going to differentiate this molecule from PD-1s dramatically by clinical data.

因此，如果你看看我們正在進行的四項研究，其中三項是針對 PD-1 的，其中兩項是專門針對 pembrolizumab 或 Keytruda 的。因此，我們將透過臨床數據將該分數與 PD-1 顯著區分。

Thank you, Allen. Really appreciate that. And so that concludes the list of questions that we have received today. So I do want to thank everyone very much for attending this morning's earnings call. As I mentioned earlier, an archived version of the webcast will be available on our website, www.smmttx.com.

謝謝你，艾倫。真的很感激。我們今天收到的問題清單到此結束。因此，我非常感謝大家參加今天早上的財報電話會議。正如我之前提到的，網路廣播的存檔版本將在我們的網站 www.smmttx.com 上提供。

And I'd like to thank you and wish you all a great day.

我要感謝你們並祝大家有個愉快的一天。

And this concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。