NovaBridge Biosciences (NBP) 2024 Q2 法說會逐字稿

Greetings. Welcome to the I-MAB Biopharma's first-half 2024 financial results and corporate update conference call. (Operator Instructions) Please note that this conference is being recorded.

問候。歡迎參加 I-MAB Biopharma 2024 年上半年財務表現及公司更新電話會議。（操作員指示）請注意，本次會議正在錄音。

I'll now hand the call to over to Tyler Ehler, Vice President, Investor Relations. Tyler, you may now begin your presentation.

我現在將電話交給投資者關係副總裁 Tyler Ehler。泰勒，你現在可以開始你的演講了。

Thank you, operator, and welcome everyone to I-MAB Biopharma's first-half 2024 financial results and corporate update conference call. This morning, I-MAB issued a press release reporting its first-half 2024 financial results and corporate update. To access a copy of the press release, please visit the Investor Relations page of the company's website.

謝謝接線員，歡迎大家參加 I-MAB Biopharma 2024 年上半年財務表現及公司更新電話會議。今天上午，I-MAB 發布了一份新聞稿，報告了 2024 年上半年的財務業績和公司最新情況。如需新聞稿副本，請造訪公司網站的投資者關係頁面。

Before we begin, I would like to remind everyone that statements made during this conference call will include forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, which involves risks and uncertainties that can cause actual results to differ materially

在我們開始之前，我想提醒大家，本次電話會議中所做的陳述將包括《1995 年私人證券訴訟改革法》安全港條款下的前瞻性陳述，其中涉及可能導致實際結果出現重大差異的風險和不確定性。

Forward-looking statements speak only as of the date they are made as the underlying facts and circumstances may change. Except as required by law, I-MAB undertakes no obligation to update these forward-looking statements to reflect future information, events, or circumstances.

前瞻性陳述僅代表其作出之日的觀點，因為基本事實和情況可能會改變。除法律要求外，I-MAB 不承擔更新這些前瞻性聲明以反映未來資訊、事件或情況的義務。

This presentation includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties as well as our own estimates of potential market opportunities.

本簡報包括我們從行業出版物和研究、第三方進行的調查和研究中獲得的統計數據和其他行業和市場數據，以及我們自己對潛在市場機會的估計。

All of the market data used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third party research, surveys, and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information.

本簡報中使用的所有市場數據都涉及一些假設和限制，請注意不要過度重視這些數據。行業出版物和第三方研究、調查和研究通常表明，它們的資訊是從被認為可靠的來源獲得的，儘管它們不保證此類資訊的準確性或完整性。

Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions. For more information on forward-looking statements, please review the disclaimers in today's press release and the risk factors in the company's SEC filings.

我們對候選產品的潛在市場機會的估計包括基於我們的行業知識、行業出版物、第三方研究和其他調查的幾個關鍵假設，這些估計可能基於小樣本量，可能無法準確反映市場機會。雖然我們相信我們的內部假設是合理的，但沒有獨立來源證實過這些假設。有關前瞻性陳述的更多信息，請查看今天新聞稿中的免責聲明和公司提交給美國證券交易委員會的文件中的風險因素。

With that, I'll now turn the call over to Dr. Sean Fu, I-MAB's Interim Chief Executive Officer and Board Director.

現在，我將把電話轉給 I-MAB 的臨時執行長兼董事會董事 Sean Fu 博士。

Thanks, Tyler, and thanks to everyone to join us today. So far this year, 2024 has been transformational for I-MAB, thanks to the excellent contributions by everyone in our organization. We are executing on the Board's vision and delivering on our strategic plan. I'm excited about our continued progress as demonstrated by significant corporate and pipeline developments.

謝謝，泰勒，也感謝今天與我們一起的所有人。到目前為止，2024 年對 I-MAB 來說是具有變革意義的一年，這要感謝我們組織中每個人的傑出貢獻。我們正在執行董事會的願景並實施我們的策略計劃。我對我們的持續進步感到興奮，這從公司和管道的重大發展中可以看出。

For this morning's call, I will make a few opening remarks regarding our strategic milestones, organization and pipeline. After that, Dr. Philip Dennis, our Chief Medical Officer, will provide an update on our three differentiated immuno-oncology therapeutic programs with upcoming milestones. And next, Joe Skelton, our Chief Financial Officer, will run through a few key financial items, including a review of our cash balance and runway. I'll wrap up with a few closing remarks, and we'll open the call for questions.

在今天早上的電話會議上，我將就我們的策略里程碑、組織和管道發表一些開場白。之後，我們的首席醫療官 Philip Dennis 博士將介紹我們三個差異化免疫腫瘤治療計畫的最新進展以及即將到來的里程碑。接下來，我們的財務長喬·斯凱爾頓 (Joe Skelton) 將介紹幾個關鍵的財務事項，包括審查我們的現金餘額和跑道。最後，我將做幾句結束語，然後我們將開始提問。

I joined I-MAB as a Board Director and Interim CEO about a month ago. As I become more familiar with the organization, I'm more enthusiastic about I-MAB and all the team has accomplished so far this year. Furthermore, I believe the combination of our differentiated pipeline, experienced leadership team, and strong cash position will allow us to make meaningful progress in the second half of 2024 and beyond.

大約一個月前，我加入 I-MAB 擔任董事會董事和臨時執行長。隨著我對該組織越來越熟悉，我對 I-MAB 以及團隊今年迄今為止的所有成就更加熱情。此外，我相信，我們差異化的產品線、經驗豐富的領導團隊以及強大的現金狀況將使我們在 2024 年下半年及以後取得有意義的進展。

I'd like to share some of our notable accomplishments from the first half of this year. First, with the divestiture of operations in China, announced earlier this year on April 2, we established a new operating model as a US-based global biotech company.

我想分享我們今年上半年所取得的一些顯著成就。首先，隨著今年4月2日宣布剝離中國業務，我們作為一家總部位於美國的全球生技公司建立了新的營運模式。

As part of the transaction, we also extinguished $183 million of a redemption obligations. Subsequent to the second quarter, we extinguished an additional $17 million of the redemption obligation. We have efficiently worked to streamline our organization and to build a new US-based leadership team which includes the addition of Joe as CFO and Philip as CMO.

作為交易的一部分，我們也解除了 1.83 億美元的贖回義務。第二季之後，我們又解除了另外 1700 萬美元的贖回義務。我們有效率地精簡了組織架構，並組建了一支新的美國領導團隊，其中包括喬 (Joe) 出任首席財務官，菲利普 (Philip) 出任首席行銷長。

From a corporate governance perspective, we successfully transitioned to having PwC US as our corporate auditor. As you will hear from Philip, we have significantly advanced our three oncology programs. We are squarely focused on execution and believe we are well positioned to make additional progress through the end of this year and beyond. As we look forward, we continue to think strategically and with an open mind to evaluate a new opportunities that could further enhance our pipeline.

從公司治理角度來看，我們成功轉型為聘請普華永道美國公司擔任我們的公司審計師。正如菲利普所說，我們的三個腫瘤學課程已經取得了顯著進展。我們全心全意地專注於執行，並相信我們有能力在今年年底及以後取得進一步的進展。展望未來，我們將繼續以策略性和開放的心態來評估可以進一步增強我們管道的新機會。

Moving to slide 5. Establishing an experienced US based management team is critical to I-MAB's long-term success. Our diverse leadership team has experiences in many areas, including: conceiving and implementing strategic plans for asset development; deep scientific know-how in developing early stage targeted therapies for cancer with a focus on immuno-oncology; identifying and completing strategic transactions, raising capitals and building successful organizations.

移至投影片 5。建立一支經驗豐富的美國管理團隊對於 I-MAB 的長期成功至關重要。我們多元化的領導團隊在許多領域擁有豐富的經驗，包括：構思和實施資產開發策略計劃；在開發以免疫腫瘤學為重點的早期癌症標靶療法方面擁有深厚的科學知識；識別和完成策略交易、籌集資金和建立成功的組織。

In my experience, these are some of the core competencies for successful biopharma companies today. Our leadership team exemplifies these core competencies.

根據我的經驗，這些是當今成功的生物製藥公司的一些核心競爭力。我們的領導團隊體現了這些核心競爭力。

Our collective professional experiences and stellar track records as one of I-MAB's most important strategic competitive advantage. I'm pleased to introduce you to the I-MAB leadership team, including our new CMO, Philip Dennis. Philip is a renowned lung cancer expert with broad clinical development expertise across a range of therapeutic modalities, with over 10 years of a big pharma focus on immuno-oncology, antibody conjugates, and targeted therapies.

我們的集體專業經驗和出色的業績記錄是 I-MAB 最重要的策略競爭優勢之一。我很高興向您介紹 I-MAB 領導團隊，包括我們的新任行銷長 Philip Dennis。Philip 是一位著名的肺癌專家，在一系列治療方式上擁有廣泛的臨床開發專業知識，並在一家大型製藥公司專注於免疫腫瘤學、抗體偶聯物和標靶治療方面擁有超過 10 年的經驗。

Our CFO, Joe Skelton, is an experienced investment banker with a track record of successfully executing numerous transactions for biotech and biopharma companies throughout his career. Our Vice President of Clinical Development, Claire Xu, brings significant clinical execution experience running oncology clinical trials and has been a core part of I-MAB's historical US operations, having been at I-MAB for almost seven years.

我們的財務長喬·斯凱爾頓 (Joe Skelton) 是一位經驗豐富的投資銀行家，在其職業生涯中曾為生物技術和生物製藥公司成功執行過無數交易。我們的臨床開發副總裁 Claire Xu 擁有豐富的腫瘤臨床試驗臨床執行經驗，並且是 I-MAB 歷史美國業務的核心部分，已在 I-MAB 工作近七年。

I'm impressed by the team's deep understanding of our clinical programs and their sincere dedication to strategically advancing our pipeline in the best way possible.

團隊對我們的臨床專案的深刻理解以及他們真誠地致力於以最佳方式策略性地推進我們的產品線，這給我留下了深刻的印象。

Moving to slide 6, our pipeline includes three oncology programs focused on providing meaningful therapeutic options to cancer patients with significant unmet medical needs. All of these assets are commercially attractive, supported by co-development and a clinical supply agreement with Bristol Myers Squibb, TJ Bio, and ABL Bio.

轉到投影片 6，我們的產品線包括三個腫瘤學項目，專注於為具有嚴重未滿足醫療需求的癌症患者提供有意義的治療選擇。所有這些資產都具有商業吸引力，並得到與百時美施貴寶、TJ Bio 和 ABL Bio 共同開發和臨床供應協議的支持。

Our lead program, uliledlimab, is an antibody that targets CD73. We are developing it for the treatment of metastatic non-small cell lung cancer and expect to initiate a frontline combination study in the first half of 2025. Meanwhile, TJ Bio, our collaborator expects to read out randomized Phase 2 PFS data combining uli and toripalimab in the second half of 2025.

我們的主導計畫 uliledlimab 是一種針對 CD73 的抗體。我們正在開發該藥物用於治療轉移性非小細胞肺癌，預計 2025 年上半年啟動第一線聯合研究。同時，我們的合作夥伴TJ Bio預計在2025年下半年讀出uli與toripalimab合併治療的隨機2期PFS數據。

Our second program, givastomig, is a bispecific antibody that targets Claudin 18.2-positive tumor cells, which conditionally activates T-cells via 4-1BB where Claudin 18.2 is expressed. We are developing givastomig for the treatment of first line gastric cancers as an add-on to the current standard of care. We expect to present updated data from our Phase 1 monotherapy dose expansion study at the European Society for Medical Oncology, or ESMO 2024 meeting in September.

我們的第二個項目 givastomig 是一種針對 Claudin 18.2 陽性腫瘤細胞的雙特異性抗體，它透過 4-1BB 有條件地活化 Claudin 18.2 表達的 T 細胞。我們正在開發 givastomig 用於治療一線胃癌，作為目前標準治療的補充。我們預計將於 9 月在歐洲腫瘤內科學會 (ESMO 2024) 會議上展示我們第 1 階段單藥治療劑量擴展研究的最新數據。

Our third program, ragistomig, is a bispecific antibody designed to provide anti-PDL1 and a 4-1BB driven T-cell activation. It has been developed for cancers that are relapsed or refractory to checkpoint inhibitors and recently presented compelling early data at ASCO 2024. I'm optimistic about our portfolio with our early clinical data, and our innovative clinical trial strategies and the strong team driving these programs forward offers us the potential to achieve important clinical milestones over the next year and beyond.

我們的第三個項目 ragistomig 是一種雙特異性抗體，旨在提供抗 PDL1 和 4-1BB 驅動的 T 細胞活化。它是為治療復發或對檢查點抑制劑有抵抗力的癌症而開發的，最近在 ASCO 2024 上展示了令人信服的早期數據。我對我們的早期臨床數據組合持樂觀態度，我們創新的臨床試驗策略和推動這些項目向前發展的強大團隊為我們提供了在未來一年及以後實現重要臨床里程碑的潛力。

With that, I would like to turn the call over to Dr. Phillip Dennis, I-MAB's, Chief Medical Officer. Philip?

接下來，我想將電話轉給 I-MAB 首席醫療官 Phillip Dennis 博士。菲利普？

Thank you Sean, and good morning everyone. Over the next few minutes, I will review the recent progress and upcoming milestones of our clinical pipeline, starting with uliledlimab, or uli for short.

謝謝肖恩，大家早安。在接下來的幾分鐘裡，我將回顧我們臨床流程的最新進展和即將到來的里程碑，從 uliledlimab（簡稱 uli）開始。

Slide 7 begins the section on uli. Uli targets CD73, which is the rate-limiting enzyme critical for converting AMP, or adenosine monophosphate into the immunosuppressive metabolite, adenosine. Blocking CD73 allows anti-tumor immunity to proceed in the tumor microenvironment without the presence of an adenosine-induced immunological fog.

幻燈片 7 開始有關 uli 的部分。Uli 的目標是 CD73，它是將 AMP 或腺苷單磷酸轉化為免疫抑制代謝物腺苷的關鍵限速酶。阻斷 CD73 可使抗腫瘤免疫在腫瘤微環境中進行，而不會出現腺苷誘導的免疫霧。

We believe uli is differentiated given its superior pharmacokinetic properties versus other competitors, as demonstrated by its ability to completely inhibit CD73 activity without the hook effect that has been described for other drugs that target CD73 and may prevent them from achieving maximal inhibition of CD73.

我們認為，uli 與其他競爭對手相比具有差異化優勢，因為它具有優異的藥物動力學特性，能夠完全抑制 CD73 活性，且不會產生其他針對 CD73 的藥物所具有的鉤狀效應，而這種效應可能會阻止其他針對 CD73 的藥物實現對 CD73 的最大抑制。

The illustrations on slide 8 were created to show uli's mechanism of action and how uli is differentiated from other CD73 antibodies. CD73 is activated when it is in a closed confirmation. We believe that uli's differentiation comes from its ability to bind to the C-terminus of the enzyme to prevent the formation of the closed dimer.

第 8 張投影片上的插圖旨在展示 uli 的作用機制以及 uli 與其他 CD73 抗體的差異。當處於關閉確認狀態時，CD73 被啟動。我們認為，uli 的分化來自於它能夠與酵素的 C 端結合，從而阻止封閉二聚體的形成。

CD73 is a butterfly structure. It has two end termini and two C termini. Because one molecule of uli binds to two adjacent CD73 dimers on the C-terminus, it doesn't exhibit the hook effect. In fact, our preclinical studies show that this approach completely inhibits CD73 in a dose dependent manner.

CD73是蝶形結構。它有兩個末端和兩個C末端。由於一個uli分子與C端的兩個相鄰的CD73二聚體結合，因此它不會表現出鉤狀效應。事實上，我們的臨床前研究表明，這種方法以劑量依賴性方式完全抑制 CD73。

In contrast when looking at other compounds such as oleclumab, which binds to the end terminus of CD73, what can happen is that as concentrations of drug increase, the intermolecular bonds needed to inhibit 73 activity are harder to form because the antibodies bind to the end terminal binding sites with single valency. Therefore intermolecular bonds are not formed as readily at high concentrations as at lower concentrations and inhibition of CD73 is paradoxically less at higher concentrations than at lower concentrations. This is not observed with uli in preclinical model systems.

相較之下，當觀察與 CD73 末端結合的其他化合物（如 oleclumab）時，可能會發生的情況是，隨著藥物濃度的增加，抑制 73 活性所需的分子間鍵更難形成，因為抗體以單價與末端結合位點結合。因此，在高濃度下分子間鍵的形成不如在低濃度下那麼容易，而且在高濃度下對 CD73 的抑制反而比在低濃度下少。在臨床前模型系統中，uli 並未觀察到這種情況。

During this call, I will walk you through the three studies from the uli program. The first study is outlined on slide 9. Data from this study presented at ASCO 2023 show that patients who had high CD73 expression and a PD-L1 TPS score of greater than or equal to 1% experienced an objective response rate, or ORR of 63%.

在這通電話中，我將向您介紹三項 uli 計畫的研究。第一項研究概述在第 9 張投影片。在 ASCO 2023 上發表的這項研究的數據顯示，CD73 表達高且 PD-L1 TPS 評分大於或等於 1% 的患者的客觀緩解率或 ORR 為 63%。

Patients with lower levels of CD73 expression had a lower ORR. The ORR in the CD73 high group is higher than that observed in keynote 42, which tested pembrolizumab monotherapy in the same disease setting and with the same distribution of PD-L1 expression. These data suggest that tumors with high levels of CD73 expression will respond best to uli. In addition to providing important proof of concept data, the study also shows that the combination was well tolerated.

CD73 表達量較低的患者的 ORR 較低。CD73 高組的 ORR 高於主題演講 42 中觀察到的 ORR，該演講在相同疾病環境和相同 PD-L1 表達分佈下測試了 pembrolizumab 單藥療法。這些數據顯示 CD73 表現量高的腫瘤對 uli 的反應最佳。除了提供重要的概念驗證數據外，該研究還表明該組合具有良好的耐受性。

Two-thirds of metastatic non-small cell lung cancer patients have tumors that express PD-L1 in less than 50% of cells. For them, the standard of care is a checkpoint inhibitor, or IO combined with chemotherapy. On Slide 10, we outline the clinical rationale for a combination study that will include uli plus IO plus chemotherapy.

三分之二的轉移性非小細胞肺癌患者的腫瘤中 PD-L1 表達細胞不到 50%。對他們來說，標準治療方法是檢查點抑制劑，或IO合併化療。在第 10 張幻燈片上，我們概述了包括 uli 加 IO 加化療的聯合研究的臨床原理。

First, the addition of chemotherapy to IO monotherapy has extended the benefit of IO to patients whose tumors express low levels of PD-L1. Second, uli has a favorable toxicity profile that suggests that the four-drug combination could be tolerated.

首先，在IO單一療法中添加化療，將IO的益處擴展到腫瘤表達量低的PD-L1患者。其次，uli 具有良好的毒性特徵，這表明四種藥物的組合是可以耐受的。

Third, published data show that chemotherapy can induce CD73 expression which could increase the likelihood of response to uli. Ultimately, non-small cell lung cancer is one of the most common and deadly cancer diagnoses globally and we believe that uli has the potential to improve upon currently available standard of care, whether that standard of care is IO monotherapy or IO plus chemotherapy.

第三，已發表的數據表明，化療可以誘導 CD73 表達，從而增加對 uli 的反應可能性。最終，非小細胞肺癌是全球最常見且最致命的癌症診斷之一，我們相信 uli 有潛力改善目前的護理標準，無論該護理標準是 IO 單一療法還是 IO 加化療。

I-MAB has received FDA clearance to proceed with the study of uli plus pembro plus chemotherapy, and we expect to dose the first patient in the first half of 2025. In the previous slide, we laid out the rationale for the four-drug combination study. This is an important study because we believe it could help define the regulatory path for uli in the future.

I-MAB 已獲得 FDA 批准，可以繼續進行 uli 加 pembro 加化療的研究，我們預計將在 2025 年上半年對第一位患者進行給藥。在上一張投影片中，我們闡述了四種藥物組合研究的理由。這是一項重要的研究，因為我們相信它有助於確定未來 uli 的監管路徑。

We intend to enroll patients who are eligible for first-line treatment of locally advanced or metastatic non-small cell lung cancer. The study is randomized against IO plus chemo standard of care and is designed to evaluate two different uli dose levels. Importantly, CD73 expression will be assessed retrospectively.

我們打算招募符合局部晚期或轉移性非小細胞肺癌第一線治療條件的患者。研究針對IO加化療標準治療進行隨機分組，旨在評估兩種不同的uli劑量水平。重要的是，CD73 表達將被回顧性評估。

The primary endpoint is objective response rate with standard secondary endpoints of progression-free survival, duration of response, and overall survival all stratified by PD-L1 expression. This study includes a small dose escalation lead-in with an n equals to six. Dosing is expected to begin in the first half of 2025. Once safety is assessed in the lead-in, patients will be randomized in a two-to-one ratio against standard of care, assessing uli with two different dose levels.

主要終點是客觀緩解率，標準次要終點是無惡化存活期、緩解持續時間和整體存活期，均以 PD-L1 表達分層。本研究包括一個小劑量遞增導入，n 等於六。預計將於 2025 年上半年開始給藥。一旦在導入過程中對安全性進行了評估，患者將按二比一的比例隨機分配接受標準治療，並使用兩種不同的劑量水平對 uli 進行評估。

In this slide, we believe it's important to share not only uli's upcoming milestones but the adenosine pathway as a whole, given its promise in the immuno-oncology space. We have prepared this chart to put the upcoming clinical milestones for uli into context with other CD73 programs.

在這張投影片中，我們認為不僅要分享 uli 即將取得的里程碑，還要分享整個腺苷通路，因為它在免疫腫瘤學領域具有廣闊的前景。我們準備了這張圖表，將 uli 即將到來的臨床里程碑與其他 CD73 計劃聯繫起來。

On the top of the chart, we have summarized three milestones for the ongoing and planned studies in our program, including the first patient dosed in the randomized Phase 2 study of uli plus pembro plus chemo I just described. We expect to be able to provide a readout from this study in the second half of 2026.

在圖表頂部，我們總結了我們計畫中正在進行和計劃進行的研究的三個里程碑，包括我剛才描述的 uli 加 pembro 加化療的隨機 2 期研究中第一位接受給藥的患者。我們預計能夠在 2026 年下半年提供這項研究的成果。

Additionally, we highlight upcoming progression-free survival, or PFS data from the uli plus toripalimab randomized Phase 2 study ongoing in China only in the second half of 2025. This study is being conducted by our collaborator in China, TJ Bio, who holds the right to uli in China.

此外，我們也重點介紹了 2025 年下半年在中國進行的 uli 加 toripalimab 隨機 2 期研究的無惡化存活期或 PFS 資料。這項研究由我們在中國的合作夥伴 TJ Bio 進行，該公司擁有在中國的使用權。

On the bottom of the chart, we summarize expected Phase 1/2 milestones for four other CD73 programs. We believe the positive results from other programs will help further validate the adenosine pathway, specifically CD73 as a target, and that our approach for patient selection using CD73 expression as well as uli's ability to completely inhibit CD73 could represent a differentiated advantage.

在圖表底部，我們總結了其他四個 CD73 項目的預期第 1/2 階段里程碑。我們相信其他項目的積極成果將有助於進一步驗證腺苷通路，特別是 CD73 作為靶點，並且我們使用 CD73 表達進行患者選擇的方法以及 uli 完全抑制 CD73 的能力可能代表差異化優勢。

Next I'd like to turn to givastomig on slide 13. Givastomig or giva is a bispecific antibody that is designed to target Claudin 18.2, a tumor-associated antigen found on solid tumors, especially gastric cancers.

接下來我想轉到第 13 張投影片上的 givastomig。Givastomig 或 giva 是一種雙特異性抗體，旨在針對 Claudin 18.2，Claudin 18.2 是一種在實體腫瘤（尤其是胃癌）中發現的腫瘤相關抗原。

The bispecific antibody combines with Claudin 18.2 binding domain, where Claudin 18.2 is expressed, and 4-1BB which conditionally activates T-cells in the tumor microenvironment. Moreover, we believe giva is differentiated by its ability to bind to Claudin 18.2 even in tumors with very low levels of 18.2 expression.

此雙特異性抗體與 Claudin 18.2 結合域（Claudin 18.2 表達處）和 4-1BB 結合，後者有條件地活化腫瘤微環境中的 T 細胞。此外，我們認為 giva 的獨特之處在於它具有與 Claudin 18.2 結合的能力，即使在 18.2 表達水平非常低的腫瘤中也是如此。

Slide 14 provides an opportunity to highlight giva's bispecific design properties and the monotherapy data that may position it as a best-in-class Claudin 18.2 4-1BB bio specific antibody. Initial Phase 1 monotherapy data reported at the ESMO 2023 meeting showed encouraging monotherapy results in patients with gastric cancers whose tumors had progressed or were refractory, including those with low levels of Claudin 18.2 expression.

幻燈片 14 提供了一個機會來強調 giva 的雙特異性設計特性和單一療法數據，這可能使其成為一流的 Claudin 18.2 4-1BB 生物特異性抗體。ESMO 2023 會議上報告的初步 I 期單藥治療數據顯示，對於腫瘤進展或難治的胃癌患者（包括 Claudin 18.2 表達水平較低的患者），單藥治療取得了令人鼓舞的結果。

Based on the data from the Phase 1 monotherapy results, we initiated a combination study of giva plus nivolumab plus chemotherapy in the first half of 2024. Bristol Myers Squibb is supplying nivolumab under a clinical collaboration and supply agreement.

根據 I 期單一治療結果的數據，我們在 2024 年上半年啟動了 giva 加 nivolumab 加化療的聯合研究。百時美施貴寶公司根據臨床合作和供應協議供應 nivolumab。

Top line data from the study are expected to read out in the second half of 2025. In the meantime, I-MAB plans to present new top line data from the Phase 1 monotherapy dose expansion study in patients with gastric cancers whose disease has progressed after previous treatment at ESMO 2024.

該研究的主要數據預計將於 2025 年下半年公佈。同時，I-MAB 計劃在 2024 年 ESMO 上展示針對既往治療後病情進展的胃癌患者的 1 期單藥治療劑量擴展研究的最新頂線數據。

Moving to slide 15, investors often ask about other Claudin 18.2 programs in development and how giva compares to zolbetuximab, or zolbe. In response, we have prepared this comparative slide. On the left side of the chart, we have summarized several parameters from the giva Phase 1 monotherapy data presented at ESMO 2023 related to Claudin 18.2 expression and clinical outcomes.

翻到第 15 張投影片，投資人經常詢問正在開發的其他 Claudin 18.2 項目以及 giva 與 zolbetuximab 或 zolbe 的比較情況。作為回應，我們準備了這張比較幻燈片。在圖表的左側，我們總結了 ESMO 2023 上展示的 giva 第 1 階段單藥治療數據中與 Claudin 18.2 表達和臨床結果相關的幾個參數。

On the right-handed columns, we summarize published Phase 1 data and Phase 2 data from zolbe. While the table does not represent data from a head-to-head study, I believe it highlights the strength of potential differentiation of giva. This data highlights giva's ability to treat patients even with low levels of Claudin 18.2 expression.

在右側欄位中，我們總結了 zolbe 已發布的第一階段資料和第二階段資料。雖然表格並不代表頭對頭研究的數據，但我相信它凸顯了 giva 潛在區分的強度。這些數據凸顯了 giva 即使在 Claudin 18.2 表達水平較低的情況下也能治療患者的能力。

For example, zolbe did not show a response in its Phase 1 study when Claudin 18.2 was expressed at 1-plus or greater in at least 1% of cells. When Claudin 18.2 parameters were tightened to 2-plus greater staining in 50% of cells, zolbe monotherapy results appeared inferior to giva monotherapy results. These data support our view that giva has best-in-class potential and could be combined with frontline standard of care nivo plus chemo in gastric cancer.

例如，當 Claudin 18.2 在至少 1% 的細胞中表達為 1+ 或更高時，zolbe 在其 I 期研究中並未顯示出反應。當 Claudin 18.2 參數收緊至 2 以上，且 50% 的細胞染色較深時，zolbe 單一療法的結果似乎不如 giva 單一療法的結果。這些數據支持我們的觀點，即 giva 具有一流的潛力，並且可以與胃癌一線標準治療 nivo 加化療相結合。

Lastly, I'd like to turn to ragistomig on slide 16. Ragistomig or ragi is a bispecific antibody in development to treat advanced solid tumors that are refractory to checkpoint inhibitors. The bispecific antibody was designed to provide anti PD-L1 activity and 4-1BB driven T-cell activation in a single molecule using the same 4-1BB technology design as giva.

最後，我想轉到第 16 張投影片上的 ragistomig。Ragistomig 或 ragi 是一種正在開發中的雙特異性抗體，用於治療對檢查點抑制劑有抵抗力的晚期實體瘤。此雙特異性抗體採用與 giva 相同的 4-1BB 技術設計，旨在單一分子中提供抗 PD-L1 活性和 4-1BB 驅動的 T 細胞活化。

The combination of an FC-silent antibody with condition 4-1BB engagement is intended to optimize the compound for safety, including the potential for lower hepatotoxicity compared to traditional 4-1BB agonists. Localized activation of 4-1BB in the tumor microenvironment is intended to enhance anti-tumor immunity and reinvigorate exhausted T-cells while mitigating liver toxicity and systemic immune responses.

FC 沉默抗體與 4-1BB 條件結合旨在優化化合物的安全性，包括與傳統 4-1BB 激動劑相比降低肝毒性的潛力。腫瘤微環境中 4-1BB 的局部活化旨在增強抗腫瘤免疫力並重新激活衰竭的 T 細胞，同時減輕肝毒性和全身免疫反應。

Slide 17 provides a snapshot of early Phase 1 dose escalation and dose expansion data presented at ASCO 2024 by our collaborator, ABL Bio. The study enrolled 53 patients with advanced or relapsed solid tumors, 44 of whom were evaluable at the time of the presentation. The majority of patients had at least three prior lines of treatment.

幻燈片 17 提供了我們的合作夥伴 ABL Bio 在 ASCO 2024 上展示的早期 1 期劑量遞增和劑量擴展數據的快照。該研究招募了 53 名晚期或復發性實體瘤患者，其中 44 名在報告時可評估。大多數患者之前至少接受過三種治療。

Top line Phase 1 results demonstrated an ORR of 27%, including six partial responses, one complete response, and a clinical benefit ratio of 69%. 71% of patients who responded had received prior checkpoint inhibitors. The complete response was observed in a heavily pre-treated ovarian cancer patient who had received seven prior lines of therapy.

第一階段的頂線結果顯示，ORR 為 27%，包括六例部分緩解、一例完全緩解，臨床獲益率為 69%。 71% 的回應患者曾接受過檢查點抑制劑治療。在一位接受過七種療法且接受過大量治療的卵巢癌患者身上觀察到了完全緩解。

We are encouraged by the results from the study because of the early clinical signs of efficacy. Enrolment in selected indications and different dose schedules is ongoing.

由於早期臨床療效的跡象，我們對研究結果感到鼓舞。針對特定適應症和不同劑量方案的招募正在進行中。

Slide 18 provides a snapshot of the safety profile. While increased liver enzymes where the most common treatment-emergent adverse event, none of the transanimated salivations were accompanied by increases in bilirubin, the so-called Hy's Law. Patients with Grade 3 increases in liver enzymes improved with corticosteroid treatment and no cytokine release syndrome was reported. The combination of ragi's early efficacy and manageable safety profile is encouraging, and enrollment in the Phase 1 study continues.

投影片 18 提供了安全概況的快照。雖然肝臟酵素升高是治療中最常見的不良事件，但轉化唾液中均未出現膽紅素升高，即所謂的海氏定律。肝酵素升高 3 級的患者經由皮質類固醇治療後病情得到改善，且沒有出現細胞激素釋放症候群。ragi 的早期療效和可控的安全性相結合令人鼓舞，第一階段研究的招募仍在繼續。

Slide 19 provides a recap of the pipeline. In summary, we are encouraged by the early clinical data for uli, giva, and ragi. We believe that each agent has a unique and differentiated mechanism of action and a manageable safety profile. We are excited to be on the cusp of clinical milestones for each program, including an upcoming data release at ESMO 2024 where we will share Phase 1 dose expansion monotherapy data.

幻燈片 19 回顧了管道。總之，uli、giva 和 ragi 的早期臨床數據令我們感到鼓舞。我們相信每種藥物都有其獨特且差異化的作用機制和可控制的安全性。我們很高興能夠達到每個項目的臨床里程碑，包括即將在 ESMO 2024 上發布的數據，屆時我們將分享第 1 階段劑量擴展單藥治療數據。

Now I will hand the call over to Joe for the financial overview.

現在我將把電話交給喬來報告財務概況。

Thank you, Phillip. As we turn to slide 20, we are shifting the discussion to corporate development and finance. As we begin, I want to make a note that we are reporting all of our financial results in US dollars.

謝謝你，菲利普。當我們翻到第 20 張投影片時，我們將討論轉向企業發展和財務。首先，我想指出的是，我們所有的財務結果都是以美元報告的。

As we begin to talk about the financials, I want to echo Sean's opening comments that I-MAB has executed on the Board's vision and made significant strategic and corporate development progress in 2024. I'll touch briefly on five key corporate parameters that we believe are strategically important for I-MAB.

當我們開始談論財務狀況時，我想重複肖恩的開場白，即 I-MAB 已經實現了董事會的願景，並在 2024 年取得了重大的策略和企業發展進展。我將簡要地談談我們認為對 I-MAB 具有戰略意義的五個關鍵公司參數。

First, we extinguished $200 million of a $215 million redemption obligation. $183 million was extinguished at the time of the divestiture with another $17 million extinguished subsequent to the end of the second quarter. We expect to extinguish the remaining obligations of approximately $15 million in September of this year.

首先，我們解除了 2.15 億美元贖回義務的 2 億美元。其中 1.83 億美元在資產剝離時被解除，另外 1,700 萬美元在第二季結束後解除。我們預計今年 9 月將償還剩餘約 1500 萬美元的債務。

Second, we streamlined the pipeline. We are advancing uli into Phase 2 in the US and are continuing to advance giva through the ongoing Phase 1b. With the divestiture of the China operations, two Phase 3 trials shifted to TJ Bio, felzartamab, and eftansomatropin alfa.

第二，我們簡化了流程。我們正在推動 uli 在美國進入第 2 階段，並繼續推進 giva 進入正在進行的 1b 階段。隨著中國業務的剝離，兩項 3 期試驗轉移到 TJ Bio、felzartamab 和 eftansomatropin alfa。

Third, we strengthened the giva clinical program through a clinical trial collaboration and supply agreement with Bristol Myers Squibb. BMS is supplying nivolumab for the triple combination study evaluating givastomig in combination with chemotherapy and nivolumab, the standard of care in frontline gastric cancer.

第三，我們透過與百時美施貴寶公司的臨床試驗合作和供應協議加強了 giva 臨床計劃。BMS 正在為三重聯合研究提供 nivolumab，該研究評估了 givastomig 與化療和 nivolumab 聯合治療胃癌一線的標準療法。

Fourth, we optimized the workforce by streamlining from 220 FTEs at year end to 34 at June 30. We've also shifted the organization so that the full senior leadership team is based on the US and the workforce is primarily based in the US. And lastly we engaged US auditors. Earlier this month, we announced that we had appointed PwC US as our financial auditors.

第四，我們優化了員工隊伍，將全職員工人數從年底的 220 人精簡到 6 月 30 日的 34 人。我們也對組織進行了調整，使整個高階領導團隊駐紮在美國，員工隊伍也主要駐紮在美國。最後我們聘請了美國審計師。本月初，我們宣布已任命普華永道美國公司為我們的財務審計師。

As we move to slide 21, I would like to take you through a pro forma cash walk using our last reported cash balance and review our cash runway expectations. Starting with our cash walk on slide 21 and moving from left to right, you can see our last reported cash balance as of December 31, 2023, was $321.8 million. And as of June 30, I-MAB's reported cash balance was $207.5 million.

當我們翻到第 21 張投影片時，我想利用我們上次報告的現金餘額，帶您進行一次形式上的現金巡查，並回顧一下我們的現金流預期。從第 21 張投影片上的現金狀況開始，從左到右，您可以看到截至 2023 年 12 月 31 日我們報告的最新現金餘額為 3.218 億美元。截至 6 月 30 日，I-MAB 報告的現金餘額為 2.075 億美元。

The delta of $114.3 million is comprised of cash outflows across five major buckets, partially offset by inflows in the second quarter. Item A, $10.8 million of the cash reported at 12/31/2023 remained with the divested I-MAB Shanghai entity to settle working capital obligations and consistent with ASC 205-20 accounting treatment, was recast to discontinued operations, bringing the comparative year-end cash balance to $311 million.

1.143 億美元的差額由五大類現金流出組成，部分被第二季的現金流入所抵銷。項目 A，即截至 2023 年 12 月 31 日報告的現金中的 1080 萬美元，仍留在剝離的 I-MAB 上海實體，以解決營運資金義務，並根據 ASC 205-20 會計處理，重鑄為已停止經營業務，使年末現金餘額為 3.11 億美元。

Item B, in the first quarter of 2024, $47.8 million in outflows were incurred related to the divestiture of China operations, including $19 million for our Series C investment in TJ Biopharma. $17.5 million placed into escrow related to arbitration with a dissenting shareholder which has been subsequently settled, foreign exchange losses incurred on the transfer of renminbi to US dollars, and other non-recurring expenditures associated with the divestiture.

B項，2024年第一季度，與剝離中國業務相關的資金流出為4780萬美元，其中包括對TJ Biopharma的C輪投資的1900萬美元；與異議股東仲裁相關的託管資金為1750萬美元（該仲裁現已解決）；人民幣兌換美元產生的外匯損失；以及與剝離支出相關的其他非經常性支出。

Item C, during the first quarter, there were $47.1 million in consolidated operating expenses to the I-MAB group pre-closing of the divestiture. Item D, in the second quarter there were $1.6 million in additional non-recurring expenses incurred associated with the divestiture.

C 項，第一季度，在資產剝離結束前，I-MAB 集團的合併營運費用為 4,710 萬美元。D項，第二季與資產剝離相關的額外非經常性支出為160萬美元。

Item E, in the second quarter there were $12.1 million in operating expenses of I-MAB as a standalone entity. Of note, there were also cash inflows of $5.1 million attributable to the return of a deposit to support the share buyback program, which the company no longer anticipates renewing, and interest income earned during the second quarter of 2024. Looking ahead, we believe that based on our current operating plans, our cash runway will take us into 2027, including several important clinical milestones.

E 項，第二季度，I-MAB 作為獨立實體的營運費用為 1,210 萬美元。值得注意的是，還有 510 萬美元的現金流入，歸因於退還了支持股票回購計劃的押金（該公司不再預期續簽該計劃），以及 2024 年第二季度獲得的利息收入。展望未來，我們相信，根據我們目前的營運計劃，我們的現金流將帶我們進入 2027 年，包括幾個重要的臨床里程碑。

Moving to slide 22, we have provided a summary of selected financial information and upcoming milestones. To recap on the financials, our cash and cash equivalents and short term investments were $207.5 million as of June 30, 2024. We believe based on our current operating plans that our cash runway will take us into 2027, including several clinical milestones. Our issued and outstanding ordinary shares represent an equivalent of 81.4 million ADS.

轉到第 22 張投影片，我們提供了精選財務資訊和即將到來的里程碑的摘要。回顧財務狀況，截至 2024 年 6 月 30 日，我們的現金、現金等價物和短期投資為 2.075 億美元。我們相信，根據我們目前的營運計劃，我們的現金流將帶我們進入 2027 年，包括幾個臨床里程碑。我們已發行且流通在外的普通股相當於 8,140 萬股 ADS。

Now I'd like to turn the call back to Sean to wrap up.

現在我想把電話轉回給肖恩來結束演講。

Thank you, Joe. As we get ready to take your questions, I'd like to summarize the company's upcoming milestones and make a few closing comments.

謝謝喬。在我們準備回答大家的問題之前，我想先總結公司即將實現的里程碑，並做幾點總結。

First, we've mapped out four upcoming milestones, two each for giva and uli. For giva, we expect to present updated Phase 1 dose expansion data at the ESMO 2024 meeting, and we expect to provide top line data from the giva combo study in gastric cancers in the second half of 2025.

首先，我們規劃了四個即將到來的里程碑，giva 和 uli 各兩個。對於 giva，我們預計將在 ESMO 2024 會議上展示更新的 1 期劑量擴展數據，並且我們預計將在 2025 年下半年提供 giva 胃癌組合研究的頂線數據。

For uli, we expected to initiate the first patient dose in the combination study in patients with advanced non-small cell lung cancer in the first half of 2025. And we expect to provide top line progression-free survival data from the randomized Phase 2 study conducted by our collaborator, TJ Bio in the second half of 2025.

對於 uli，我們預計將於 2025 年上半年在晚期非小細胞肺癌患者中啟動聯合研究中的首例患者劑量。我們預計將在 2025 年下半年提供我們的合作夥伴 TJ Bio 進行的隨機 2 期研究的頂級無惡化存活期數據。

As we conclude today's prepared remarks, I'd like to leave you with these key messages. I-MAB is exclusively focused on the development of differentiated immunotherapies for cancer. 2024 has been transformational for I-MAB. With the divestiture of operations in China announced on April 2, we established a new operating model as a US based global biotech company.

在我們結束今天的準備好的演講時，我想向大家傳達以下這些關鍵訊息。I-MAB 專注於開發差異化的癌症免疫療法。 2024 年對 I-MAB 來說是轉型的一年。隨著4月2日宣布剝離中國業務，我們作為一家總部位於美國的全球生技公司建立了新的營運模式。

Thanks to the excellent contributions by everyone in our organization, we are executing on the Board's strategic vision. We have significantly advanced our three oncology programs and worked efficiently to streamline our organization, build a new US based leadership team, and complete key governance and corporate development milestones.

感謝我們組織中每個人的傑出貢獻，我們正在執行董事會的策略願景。我們顯著推進了我們的三個腫瘤學項目，並有效地精簡了我們的組織，建立了一個新的美國領導團隊，並完成了關鍵的治理和企業發展里程碑。

As we look forward, we'll continue to think strategically to evaluate the new opportunities to further enhance our pipeline. We are squarely focused on execution, and we believe the combination of our differentiated pipeline, experienced leadership team, and strong cash balance position will let us to make meaningful progress in the second half of 2024 and beyond.

展望未來，我們將繼續進行策略思考，評估新機遇，進一步增強我們的產品線。我們非常注重執行，我們相信，我們差異化的產品線、經驗豐富的領導團隊以及強大的現金餘額狀況將使我們在 2024 年下半年及以後取得有意義的進展。

Now I would like to thank everyone for listening to our call and ask the operator to please open the call for questions.

現在，我要感謝大家收聽我們的電話會議，並請接線生打開電話會議來回答問題。

(Operator Instructions) Joe Catanzaro, Piper Sandler.

（操作員指示）Joe Catanzaro、Piper Sandler。

Hey everybody, thanks for taking my questions. I maybe had a couple on givastomig, first one on the upcoming ESMO update. Wondering if you could just help sort of set expectations in terms of the data set we'll see, patient numbers and any new learnings around the monotherapy profile there.

大家好，感謝你們回答我的問題。我可能對 givastomig 有過一些了解，第一個是關於即將到來的 ESMO 更新的。想知道您是否可以幫助我們根據我們將看到的數據集、患者人數以及有關單一療法概況的任何新了解來設定預期。

Then second question, appreciate the comparison to zolbetuximab, but wondering if you had any thoughts on how giva maybe compares to the growing Claudin 18.2 ADC landscape and where it could differentiate versus those programs. Thanks.

然後是第二個問題，感謝您與 zolbetuximab 的比較，但想知道您是否對 giva 與不斷發展的 Claudin 18.2 ADC 領域相比有何看法，以及它與這些程式的區別在哪裡。謝謝。

Thank you for your question, Joe. We'll turn that question over to our Chief Medical -- go ahead, Tyler?

謝謝你的提問，喬。我們會把這個問題交給我們的首席醫療官——泰勒，可以問一下嗎？

I was just going to say, we'll turn that question over to our Chief Medical Officer, Dr. Phillip Dennis.

我只是想說，我們將把這個問題轉交給我們的首席醫療官菲利普·丹尼斯博士。

Thanks, Tyler, and thanks for the question. The data presented at ESMO again will be data from the dose expansion cohorts with gastric cancer. This will be with approximately 30 patients, and the profile is again one of exquisite safety and again a notable ORR.

謝謝，泰勒，謝謝你的提問。ESMO 上再次展示的數據將是來自胃癌劑量擴展隊列的數據。這將涉及約 30 名患者，其結果再次顯示出極其安全的療效和顯著的 ORR。

But importantly, I think you raise an important question. The way we envision giva's development, given its tolerability, is to combine it with frontline therapy with nivolumab and regimens such as FOLFOX. And I think that is the basis for the differentiation with other 18.2 targeted assets.

但重要的是，我認為你提出了一個重要的問題。考慮到 giva 的耐受性，我們設想將其發展方式與 nivolumab 的一線療法和 FOLFOX 等方案相結合。我認為這是與其他 18.2 目標資產差異的基礎。

So while we know that ADCs, given their toxic payload, can have a notable objective response rate, which again if we compared giva against the ADC that is being developed by AstraZeneca, our ORR is inferior; but arguably, our tox profile is much better suited for combination in frontline studies, and I think that's the differentiating feature.

因此，雖然我們知道 ADC 考慮到其毒性載荷，可以具有顯著的客觀反應率，但如果我們將 giva 與阿斯特捷利康正在開發的 ADC 進行比較，我們的 ORR 較低；但可以說，我們的毒性特徵更適合在前線研究中進行組合，我認為這就是差異化特徵。

I think for an ADC targeting 18.2, for movement to frontline therapy, one would have to make accommodations in the standard of care chemotherapy because it simply would be very difficult to tolerate an ADC plus every drug that's in FOLFOX, for example. So I think that's a differentiating feature where we can be more readily combined with frontline therapy.

我認為，對於靶向 18.2 的 ADC，為了轉向一線治療，人們必須在標準治療化療中做出調整，因為要耐受 ADC 加上 FOLFOX 中的每種藥物是非常困難的。所以我認為這是一個差異化特徵，我們可以更容易地將其與第一線療法結合。

Okay, great. That's all helpful. Thanks for taking my questions.

好的，太好了。這些都很有幫助。感謝您回答我的問題。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

Hi this [Zach Ho Shu] for Kelly Shi. Congrats on the progress in the first half of '24. I just have two quick questions. First, what is your targeted finish date for the transitioning to the US based auditors? What should we think about expenses going forward split between the US and China?

大家好，我是石凱莉的[Zach Ho Shu]。恭喜 24 年上半年的進展。我只有兩個簡短的問題。首先，您向美國審計師過渡的目標完成日期是什麼時候？我們該如何看待美國和中國未來的費用分攤？

My second question is for the pipeline strategy, as you're thinking about expansion to your -- adding more assets to your pipeline, are you still focusing on the oncology space or looking to expand to other therapeutic areas? Thank you.

我的第二個問題是關於管道策略，當您考慮擴展您的管道時—為您的管道增加更多資產，您仍然專注於腫瘤學領域還是尋求擴展到其他治療領域？謝謝。

Thank you for your question, Kelly. Was it possible to repeat the first question, and then we'll turn the question over to Sean, our interim CEO to answer?

謝謝你的提問，凱利。是否可以重複第一個問題，然後我們將問題交給我們的臨時執行長肖恩來回答？

Sure. The first question is what's your target finish date regarding fully transitioning to a US based auditor?

當然。第一個問題是，全面過渡到美國審計師的目標完成日期是什麼時候？

Yeah, thanks for that question. We have completed the transition, and PwC US is now our corporate auditor and we've been working closely with them since the completion of the transition. So this is an important accomplishments. And together with other corporate developments after the divestiture, they started to see the change in, as a company, how I-MAB is allocating resources.

是的，謝謝你的提問。我們已經完成了過渡，普華永道美國現在是我們的企業審計師，自過渡完成以來我們一直與他們密切合作。所以這是一個重要的成就。並且，隨著資產剝離後公司的其他發展，他們開始看到 I-MAB 作為一家公司在資源分配方式上的變化。

The going burn rate, I think that's part of the question you asked earlier. The going burn rate will be considerably lower compared to what you saw in the first and second quarters of this year, because we have streamlined our organization to focus on clinical development programs going forward.

目前的燃燒率，我認為這是你之前提出的問題的一部分。與今年第一季和第二季相比，目前的燒錢率將大幅降低，因為我們已經精簡了組織，並將重點放在未來的臨床開發計畫上。

And the other question, you asked about the pipeline strategy, yes, we are actively looking to further enhance our pipeline through external collaboration or licensing opportunities. And obviously given that the three assets internally are all oncology focused, our team has significant oncology asset development experience that we are starting our reviews, our explorations in the oncology space, but we are not limiting ourselves just to oncology. For adjacent modalities, we are also open for discussion and collaboration, but oncology is one area we obviously see synergy.

另一個問題是有關管道策略，是的，我們正在積極尋求透過外部合作或許可機會進一步加強我們的管道。顯然，鑑於我們內部的三項資產都以腫瘤學為重點，我們的團隊擁有豐富的腫瘤學資產開發經驗，我們正在開始對腫瘤學領域的審查和探索，但我們並不局限於腫瘤學。對於鄰近的治療方式，我們也願意進行討論和合作，但腫瘤學是我們明顯看到協同作用的一個領域。

And I think the final part of the question has to do with going forward, the pipeline strategy. We are squarely focused on execution of our internal pipeline, the three that we explained in detail today by Phillip, and we are excited about this pipeline, so we're looking to license in and we're looking for collaboration opportunities from external partners.

我認為問題的最後一部分與未來的管道策略有關。我們完全專注於內部管道的執行，即菲利普今天詳細解釋的三個管道，我們對這個管道感到興奮，因此我們正在尋求許可，並正在尋找來自外部合作夥伴的合作機會。

Important to note that when we think about the BD strategy, we are looking for assets that has the potential to enter or are already in clinical stage, therefore we can expect it to bring a near term value inflection for I-MAB in the next year.

值得注意的是，當我們考慮 BD 策略時，我們正在尋找具有進入或已經處於臨床階段的潛力的資產，因此我們可以預期它將在明年為 I-MAB 帶來短期價值轉折點。

Great. Thank you.

偉大的。謝謝。

(Operator Instructions) Andres Maldonado, H.C. Wainwright.

（操作員指示）Andres Maldonado，H.C. Wainwright。

Hi, thank you. Congratulations on the progress. Thank you for taking my question. Just two quick ones from me. For the uliledlimab combination study, could you talk a little bit about what you need to see on the efficacy front for this new study, and what are some of the external signals you're using to benchmark your go/no-go decision?

你好，謝謝。恭喜你取得進展。感謝您回答我的問題。我只想簡單說兩句話。對於 uliledlimab 組合研究，您能否談談您需要在這項新研究的療效方面看到什麼，以及您使用哪些外部訊號來衡量您是否可以進行該研究？

And then as an additive question, in the second half the Phase 2 PFS data from the TJ Bio study, just curious on how you're going to leverage that data moving forward and what you need to see there. Thank you very much for taking my questions.

然後作為一個附加問題，在 TJ Bio 研究的後半部分第 2 階段 PFS 數據中，我只是好奇您將如何利用這些數據向前發展以及您需要在那裡看到什麼。非常感謝您回答我的問題。

Thank you for your question, Andres. I will direct your question to our Chief Medical Officer, Dr. Phillip Dennis. Phillip?

謝謝你的提問，安德烈斯。我會將您的問題轉交給我們的首席醫療官菲利普·丹尼斯博士。菲利普？

Thanks. And I will address the questions in order, and if I don't do so completely, please let's make sure I address all of them. In terms of benchmarks for efficacy in our Phase 2, the sense is the comparison is keynote 189, where we know the median PFS is about nine months, and we know the ORR can vary depending on the PD-L1 expression.

謝謝。我將按順序回答這些問題，如果我沒有完全回答，請確保我回答所有問題。就我們第 2 階段的療效基準而言，意義在於比較主題演講 189，其中我們知道中位 PFS 約為 9 個月，我們知道 ORR 可能因 PD-L1 表達而異。

So basically what we're looking for is clinically meaningful improvements, incremental improvements that are clinically meaningful over the standard of care, Keynote 189. Moreover, in our proposed Phase 2, we'll be assessing CD73 retrospectively and we will be focused heavily on whether or not the signals that we are seeing are predominantly in that CD73 positive group.

因此，基本上，我們所尋求的是具有臨床意義的改進，即在臨床上比護理標準更有意義的漸進式改進，Keynote 189。此外，在我們提議的第 2 階段中，我們將回顧性地評估 CD73，並將重點放在我們看到的訊號是否主要存在於 CD73 陽性組中。

Now in terms of external benchmarks, as the slide showed, we're very interested in outcomes from competitor studies because positive outcomes from these competitor studies will really validate the adenosine pathway, and these studies include studies with oleclumab that is being developed by AstraZeneca in earlier stages of disease, resectable disease, stage three unresectable disease, as well as antibodies, again CD39 in small molecules.

現在就外部基準而言，正如幻燈片所示，我們對競爭對手研究的結果非常感興趣，因為這些競爭對手研究的積極結果將真正驗證腺苷途徑，這些研究包括阿斯特捷利康正在開發的針對疾病早期階段、可切除疾病、第三期不可切除疾病的 oleclumab 研究，以及抗體，再次是小分子中的 CD39。

So we think that this will help again propel the field forward, give us confidence in uli, in the pathway, and I think with the signal that we hope to see from our study, from our proposed study with pembro chemo and with the TJ Bio doublet study, that is in the CD73 selected population, we will get support for our hypothesis that it's the patients that have high CD73 expression that benefit most from uli.

因此，我們認為這將有助於再次推動該領域的發展，讓我們對 uli 和該途徑充滿信心，我認為我們希望從我們的研究中看到的信號，從我們提出的 pembro 化療研究和 TJ Bio 雙聯研究中看到的信號，即在 CD73 選定的人群中，我們將得到對我們假設的支持，即具有高 CD73 表達的患者從中受益最多。

Great. Thank you very much.

偉大的。非常感謝。

Thank you. At this time, we have no additional questions, and I'll hand the call back to Dr. Sean Fu for closing remarks.

謝謝。目前，我們沒有其他問題，我將把電話交還給 Sean Fu 博士進行結束語。

Great. Thank you very much again for taking the time to join our call today. As you can gather from the discussions and the presentations, we're very excited about the pipeline, and the team is dedicated to continue to push the pipeline forward in the most efficient and scientific way.

偉大的。再次非常感謝您抽出時間參加我們今天的電話會議。從討論和演示中您可以了解到，我們對該管道感到非常興奮，並且團隊致力於繼續以最有效和科學的方式推動該管道向前發展。

We look forward to updating you on our future progress, and if you have any follow-up questions, please reach out to Tyler Ehler, our Head of Investor Relationships. Have a great day. You may now disconnect the call.

我們期待向您通報我們未來的進展，如果您有任何後續問題，請聯絡我們的投資人關係主管 Tyler Ehler。祝你有美好的一天。您現在可以掛斷電話了。

This will conclude today's conference. Thank you for your participation.

今天的會議到此結束。感謝您的參與。