Allogene Therapeutics, Inc. (ALLO) 2026 Q2 法說會逐字稿

Hello. Thank you for standing by and welcome to Allogene Therapeutics second-quarter 2026 conference call. (Operator Instructions) Please be aware that today's conference call is being recorded.

您好。感謝您稍候並歡迎參加 Allogene Therapeutics 2026 年第二季財報電話會議。（接線員指示）請注意，今天的電話會議將被錄音。

I would now like to turn the call over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. Ms. Cassiano, please go ahead.c

現在我想把電話交給企業事務與品牌策略長 Christine Cassiano。Cassiano 女士，請開始。c

Thank you, Operator, and welcome everyone to Allogene's conference call. After the market closed, Allogene issued a press release that provided a business update and financial results for the second quarter of 2026. This press release and today's webcast are available on our website. Following brief prepared remarks from Dr. Zachary Roberts, President and Chief Executive Officer, we will open the call for questions. Geoff Parker, Chief Financial Officer, will also join the Q&A. To help us conclude within 45 minutes, we ask that each analyst limit themselves to one question.

謝謝接線員，也歡迎各位參加 Allogene 的電話會議。於美股收盤後，Allogene 發布新聞稿，提供 2026 年第二季的業務更新與財務結果。該新聞稿與今天的網路直播可在我們的網站上取得。在 Zachary Roberts 醫師（總裁兼執行長）簡短的事先準備發言後，我們將開放提問。財務長 Geoff Parker 也將加入問答環節。為協助我們在 45 分鐘內結束，我們請每位分析師將問題限制為一題。

During today's call, we will be making certain forward-looking statements These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, commercial market forecasts, the potential treatment setting, and financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements.

在今天的電話會議中，我們將作出若干前瞻性陳述。這些陳述可能包括：我們正在進行及計畫中的臨床試驗之成功與時程、數據發表、法規申報、未來研發工作、製造能力、候選產品的安全性與有效性、商業市場預測、潛在治療場景以及財務指引等。這些前瞻性陳述係基於目前資訊、假設與預期，且可能發生變動。潛在風險之說明可見於我們的新聞稿及最新的 SEC 揭露文件。敬請勿過度依賴這些前瞻性陳述，Allogene 亦不承擔更新此等陳述之任何義務。

I'm going to turn the call over to Zach.

我現在把電話交給 Zach。

Thanks, Christine, and good afternoon, everyone. This is my first quarterly call as CEO, and it marks the beginning of a new chapter for Allogene, one made possible by the foundation David Chang helped build. David has been my mentor and one of the people who has most shaped how I think about cell therapy and drug development. More than that, he co-founded and built this company, led the field in the generation of clinical data in patients with relapsed cancer, and created the framework we needed to take Allogene into its next chapter.

謝謝你，Christine，各位下午好。這是我擔任執行長後的第一場季度電話會議，也標誌著 Allogene 新篇章的開始；這一切得以實現，源於 David Chang 協助奠定的基礎。David 一直是我的導師，也是最深刻影響我如何思考細胞治療與藥物開發的人之一。不僅如此，他共同創辦並打造了這家公司，在復發癌症患者的臨床數據產出方面引領了領域發展，並建立了我們帶領 Allogene 進入下一篇章所需的框架。

When I joined Allogene, my mandate was clear. Challenge the conventional thinking about how allogeneic CAR-T should be developed. That meant starting with the patient and working backward. Understand what patients and their care teams need, then design products and clinical programs that meet those needs. That work led to a deliberate strategic shift announced in 2024, designing programs and products that leverages features of the allogeneic cell therapy into a clinical advantage.

當我加入 Allogene 時，我的任務很明確：挑戰對同種異體 CAR-T 應如何開發的傳統思維。這意味著從病人出發並反向推導：理解病人及其照護團隊的需求，然後設計能滿足這些需求的產品與臨床計畫。這項工作促成了我們在 2024 年宣布的一項審慎策略轉向——設計能運用同種異體細胞治療特性、轉化為臨床優勢的計畫與產品。

We focused on settings that demand the unique attributes of off-the-shelf CAR T, ready availability, consistent product quality that is independent of the patient's immune status, and crucially, the ability to treat patients locally. Allogeneic CAR T is not a stepping stone between autologous therapy and whatever may come next. It is a distinct platform capable of filling gaps existing modalities cannot and progress across ALPHA3, ALLO-316 and ALLO-329 is beginning to demonstrate those advantages in practice.

我們聚焦於需要「現成型」CAR T 獨特屬性的治療情境：可即時取得、與病人免疫狀態無關的一致產品品質，以及關鍵的——能在本地為病人治療。同種異體 CAR T 並非自體療法與未來可能出現之下一代療法之間的過渡踏板；它是一個獨立的平台，能填補現有治療方式無法覆蓋的缺口。而 ALPHA3、ALLO-316 與 ALLO-329 的進展，正開始在實務上展現這些優勢。

I will start with ALPHA3 because it is the clearest expression of this strategy. ALPHA3 arose from a simple premise. Can we identify patients at high risk of relapse after first-line treatment and intervene with CAR-T before the disease returns clinically? By treating earlier, the study aims to prevent relapse while avoiding much of the toxicity associated with standard second-line therapies, including autologous CAR-T. The trial is also designed to prove that we can overcome longstanding access barriers by enabling patients to receive CAR-T where they already received their first-line care in the community with the same doctors who gave them their first-line treatment.

我將先從 ALPHA3 談起，因為它最清楚地體現了這項策略。ALPHA3 源自一個簡單前提：我們能否辨識在一線治療後具有高度復發風險的病人，並在疾病尚未臨床復發前以 CAR-T 介入？透過更早治療，本研究旨在預防復發，同時避免標準二線治療（包括自體 CAR-T）所伴隨的多數毒性。該試驗亦旨在證明，我們可以克服長期存在的可近性障礙，讓病人在社區端、於其接受一線治療的同一處所、由提供一線治療的同一批醫師，接受 CAR-T 治療。

Testing this required a more precise way to identify patients at high risk of relapse. Standard methods used at diagnosis, such as disease stage and IPI, lack sufficient specificity because many patients classified as high risk by those methods are still cured with R-CHOP. That new tool emerged just weeks before I joined Allogene. When I saw the Foresight now Natera CLARITY data presented at ASH 2022, the design of ALPHA3 came into focus.

要驗證這一點，需要更精準的方法來辨識高復發風險病人。診斷時常用的標準方法（例如疾病分期與 IPI）特異性不足，因為許多依這些方法被歸類為高風險的病人，仍可透過 R-CHOP 治癒。就在我加入 Allogene 的幾週前，一項新工具浮現。當我看到在 ASH 2022 發表的 Foresight（現為 Natera）CLARITY 數據時，ALPHA3 的設計便清晰成形。

When ALPHA3 began, MRD in large B-cell lymphoma was viewed largely as an academic research tool. We believed it could become far more a standard marker patient's prognosis and, if properly validated, a new treatment decision point. That view is gaining traction not only in LBCL but across oncology. In May, the FDA approved Tecentriq as adjuvant therapy for patients with bladder cancer who are in radiographic remission but remain MRD positive by circulating tumor DNA. The approval, based on the IMvigor011 study, is the first where patient selection was based solely on a ctDNA MRD test. IMvigor011 closely parallels ALPHA3's design and this approval, as well as a new Category 1 NCCN recommendation, signals a broader shift toward using MRD as a treatment decision trigger rather than waiting for clinical relapse.

ALPHA3 啟動之初，大 B 細胞淋巴瘤的 MRD 多被視為學術研究工具。我們相信它可以更進一步成為病人預後的標準指標，並在適當驗證後成為新的治療決策節點。這個觀點不僅在 LBCL，也在整個腫瘤領域逐漸獲得認同。5 月，FDA 核准 Tecentriq 作為輔助治療，用於膀胱癌影像學緩解但以循環腫瘤 DNA 檢測仍為 MRD 陽性的病人。該核准基於 IMvigor011 研究，為首個僅以 ctDNA MRD 檢測作為病人篩選依據的核准。IMvigor011 與 ALPHA3 的設計高度相似，而此項核准以及新的 NCCN 第 1 類建議，顯示整體趨勢正轉向以 MRD 作為啟動治療的決策觸發點，而非等待臨床復發。

Fast forward to our first look at data from the ALPHA3 trial in April, the interim futility analysis, which provided an important early test of ALPHA3's hypothesis. Cema-Cel drove rapid MRD clearance in a majority of patients and did so with no treatment-related hospitalizations. Most patients were treated and followed entirely in the outpatient setting. And importantly, Cema-Cel was successfully delivered in community practices with no prior CAR-T experience. Together, those findings support ALPHA3's potential to change the lymphoma landscape by offering CAR-T earlier with less logistical burden and greater access across more treatment settings.

時間快轉到 4 月我們首次看到 ALPHA3 試驗數據——期中無效性分析（interim futility analysis），這為 ALPHA3 的假設提供了一項重要的早期檢驗。Cema-Cel 使多數病人快速達到 MRD 清除，且未出現任何與治療相關的住院。多數病人完全在門診環境接受治療與追蹤。更重要的是，即使是先前沒有 CAR-T 經驗的社區醫療機構，也成功完成了 Cema-Cel 的給藥。綜合而言，這些發現支持 ALPHA3 有潛力改變淋巴瘤治療版圖：更早提供 CAR-T、降低後勤負擔，並在更多治療場域提升可近性。

At the end of July, the FDA granted both RMAT and Fast Track designations for Cema-Cel in first-line consolidation. These designations are based on two critical points. First, FDA acknowledges that MRD positivity at the end of first-line treatment is an unmet medical need. And second, Cema-Cel has the potential to meet that need. need. We interpret this action by FDA as validation for the ALPHA3 program. Additionally, RMAT creates an important opportunity for more frequent and focused engagement as we advance the trial. That engagement will be central to how we move forward.

7 月底，FDA 授予 Cema-Cel 用於一線鞏固治療（first-line consolidation）的 RMAT 與 Fast Track 資格認定。這些認定基於兩個關鍵點。第一，FDA 認可一線治療結束時 MRD 陽性屬於未被滿足的醫療需求。第二，Cema-Cel 具有滿足該需求的潛力。need. 我們將 FDA 的此項行動解讀為對 ALPHA3 計畫的驗證。此外，RMAT 也創造了一個重要機會，使我們在推進試驗時能更頻繁且更聚焦地與 FDA 互動；這種互動將是我們後續推進方式的核心。

Our objective is clear. Execute the study well, protect its integrity, and work with the FDA toward the most efficient development and regulatory path. As enrollment continues, we expect opportunities in 2027 to update investors on the program, including enrollment progress and potential data such as the planned interim EFS analysis. The timing and scope of these updates will of course be guided by our regulatory discussions and the independent data monitoring committee. In the meantime, we will communicate meaningful operational and regulatory progress.

我們的目標很明確：把研究執行好、維護其完整性，並與 FDA 合作，朝向最有效率的開發與法規路徑前進。隨著收案持續進行，我們預期在 2027 年有機會向投資人更新該計畫進展，包括收案進度以及可能的數據（例如規劃中的期中 EFS 分析）。這些更新的時點與範圍，當然將由我們與監管機關的討論以及獨立資料監測委員會所指引。在此期間，我們將持續溝通具意義的營運與法規進展。

Today we are proud to provide one such operational update. We entered the year with a goal of activating over 80 clinical sites by year end. With strong execution by the team and increased investigator interest following the interim futility analysis, we reached that goal in July. New academic and community-based investigators have asked to join the trial, citing enthusiasm for the initial MRD clearance data and safety profile and growing momentum of MRD testing in lymphoma.

今天我們很自豪提供其中一項營運更新。我們在年初設定的目標是於年底前啟動超過 80 個臨床試驗中心。憑藉團隊的強力執行，以及期中無效性分析後研究者興趣提升，我們已於 7 月達成該目標。新的學術型與社區型研究者已要求加入試驗，並表示其原因在於對初步 MRD 清除數據與安全性特徵的熱忱，以及淋巴瘤領域 MRD 檢測動能日益增強。

As a result, we now expect to have approximately 100 sites active by year end with the significant majority in the United States and additional sites in Canada, Australia, and South Korea. This expansion reflects growing investigator conviction in MRD and the ALPHA3 strategy, supports enrollment momentum, and gives more sites hands-on experience with Cema-Cel's ease of use ahead of a potential commercial launch.

因此，我們現在預期到年底將有約 100 個據點啟用，其中絕大多數位於美國，並在加拿大、澳洲與南韓新增據點。此一擴張反映研究者對 MRD 與 ALPHA3 策略日益增強的信心，支持入組動能，並讓更多據點在潛在商業化上市前，親身體驗 Cema-Cel 的易用性。

Turning to ALLO-316, the publication of the TRAVERSE results in the Journal of Clinical Oncology was an important milestone for the program and the Dagger platform. Solid tumors have been CAR T's hardest test. In patients with CD70 high renal cell carcinoma, ALLO-316 produced a 31% confirmed overall response rate the optimized regimen.

接著談 ALLO-316，《臨床腫瘤學期刊》（Journal of Clinical Oncology）發表 TRAVERSE 結果，是該計畫與 Dagger 平台的重要里程碑。實體腫瘤一直是 CAR T 最艱難的考驗。在 CD70 高表達的腎細胞癌患者中，ALLO-316 在最佳化給藥方案下達到 31% 的經確認整體反應率。

At the data cutoff, none of the five confirmed responders had experienced disease progression, with follow-up ranging from eight months to more than 18 months after a single dose of ALLO-316. The data set is small, and the program has faced real safety challenges. We've been direct about both. But consistently, confirmed responses with this degree of durability in a solid tumor are notable. Just as important, the translational work gives us a much clearer view of the underlying biology of these responses using CAR T-cell expansion, persistence, tumor infiltration, and the contribution of Dagger.

截至資料截點，五位經確認的反應者均未出現疾病進展；在單次給予 ALLO-316 後，追蹤時間介於 8 個月至超過 18 個月。資料集規模不大，且該計畫確實面臨安全性挑戰；我們對這兩點都坦率以對。然而，在實體腫瘤中能持續觀察到如此耐久度的經確認反應，仍值得關注。同樣重要的是，轉譯研究讓我們更清楚理解這些反應背後的生物學機制，包括 CAR T 細胞的擴增、持續性、腫瘤浸潤，以及 Dagger 的貢獻。

TRAVERSE also demonstrates how we operate. There were moments when the conventional decision would have been to stop development of ALLO-316. When toxicity emerged, our team brought in outside experts, engaged with the FDA, developed the management algorithm and continued learning. That work gave us a pathway to manage the most serious events while advancing understanding of an increasingly recognized immunotherapy toxicity and allowed us to generate the foundational clinical evidence for our Dagger technology pipeline.

TRAVERSE 也展現了我們的運作方式。曾有一些時刻，依照傳統決策可能會停止 ALLO-316 的開發。當毒性出現時，我們的團隊引入外部專家、與 FDA 互動、制定處置演算法並持續學習。這些工作讓我們得以在推進對一種日益被認可之免疫治療毒性的理解同時，找到管理最嚴重事件的途徑，並使我們能為 Dagger 技術管線建立基礎性的臨床證據。

We are still far from declaring victory in solid tumors, but these results provide encouragement to keep pushing. They move the field forward and reinforce the principle that is central to allergy. When the biology is sound, we stay focused, learn from the data, and continue advancing the science.

我們距離在實體腫瘤中宣告勝利仍很遙遠，但這些結果提供了持續推進的鼓舞。它們推動了領域向前，也強化了對 Allogene 的核心原則：當生物學基礎扎實時，我們就保持專注、從資料中學習，並持續推進科學。

That same focus on thoughtful program design brings me to ALLO-329 and the RESOLUTION trial in autoimmune disease, where the core message is execution. Enrollment has moved quickly across cohorts, dose levels, and lymphodepletion strategies, even in a highly competitive field. We believe that momentum reflects a program designed with patients as the focus rather than one that asks them to adapt to the technology.

同樣對周延計畫設計的專注，帶我談到 ALLO-329 與其在自體免疫疾病中的 RESOLUTION 試驗；其核心訊息是執行力。即使在競爭激烈的領域中，入組仍在不同隊列、劑量層級與淋巴清除策略間快速推進。我們相信，這股動能反映的是一個以患者為核心設計的計畫，而不是要求患者去配合技術。

ALLO-329 was designed with Dagger from the outset. Rather than designing another CAR-T product that requires chemotherapy-based lymphodepletion to work, the product is designed to function better when confronted by the biology of allo rejection by targeting the activated host T cells that contribute to it. Our objective is to both identify the optimal dose regimen for ALLO-329 and to understand how its cell dose, lymphodepletion, and Dagger work together. Strong enrollment and execution are keeping us on track to report a clinical and translational update by year end.

ALLO-329 從一開始就以 Dagger 進行設計。我們不是再設計一個必須依賴化療式淋巴清除才能發揮作用的 CAR-T 產品；相反地，該產品被設計為在面對同種異體排斥的生物學時能更好運作，透過鎖定促成排斥反應的活化宿主 T 細胞。我們的目標是同時找出 ALLO-329 的最佳劑量方案，並理解其細胞劑量、淋巴清除與 Dagger 如何協同作用。強勁的入組與執行力使我們仍按計畫在年底前發布臨床與轉譯更新。

Across all three programs, the through line is clear. We embrace the features of allogeneic CAR-T as unique strengths and have designed programs to allow us to meet the demands of patients when and where they arise. Over the next 12 months, we expect the value of that work to become increasingly visible, beginning with an ALLO-329 update by year-end and opportunities to update investors on ALPHA3 throughout 2027. Those milestones will help define our progress, but the standard we are working toward is simpler. Innovation only matters if patients can actually access it.

在三個計畫中，主軸非常清楚：我們將同種異體 CAR-T 的特性視為獨特優勢，並設計計畫以便在患者需求出現的時間與地點滿足他們。未來 12 個月內，我們預期這些工作的價值將愈發清晰，首先是年底前的 ALLO-329 更新，以及在 2027 年期間多次向投資人更新 ALPHA3 的機會。這些里程碑將有助於界定我們的進展，但我們追求的標準更為簡單：創新只有在患者真正能取得時才有意義。

We'll now open the call for questions.

我們現在開放提問。

(Operator Instructions) Michael Yee, UBS.

（接線員指示）Michael Yee，瑞銀（UBS）。

Hey, good afternoon, guys. This is Matt on for Mike. Thank you so much for taking your questions. I wanted to add, I saw you guys added an observational cohort to the ALPHA3 study, and I just wanted to ask about kind of the design of this cohort, maybe what the goal of it is, and kind of the questions you're helping to answer. It looks like it's an MRD negative patient. So just to kind of expand on kind of what the goals are. I'm wondering how we could just show what that observational cohort might be.

嗨，大家午安。我是 Matt，代替 Mike 發言。非常感謝讓我提問。我想補充一下，我看到你們在 ALPHA3 研究中新增了一個觀察性隊列，我想請教這個隊列的設計大概是怎樣、目標是什麼，以及你們希望藉此回答哪些問題。看起來是 MRD 陰性的患者。所以想請你們再延伸說明一下目標。我也想了解我們可以如何呈現那個觀察性隊列可能會是什麼樣子。

Thank you so much. Matt, thanks for the question. So it's pretty straightforward. We added this cohort to help provide context for the overall results of ALPHA3 looking at the MRD-positive patients. Of course, those are the ones that we randomized now into ALPHA3, so having a paired MRD-negative cohort using essentially the same patient population as this is coming into ALPHA3 itself, will give that ability to compare outcomes in the observational cohort of the MRD positive patients as ALPHA3 with the MRD negative patients as well. So really it will give us the ability to further characterize the test itself in a prospective manner.

非常感謝。Matt，謝謝你的問題。其實相當直接。我們新增這個隊列，是為了在檢視 ALPHA3 針對 MRD 陽性患者的整體結果時提供背景脈絡。當然，這些 MRD 陽性患者現在已在 ALPHA3 中被隨機分派；因此，加入一個配對的 MRD 陰性隊列，且基本上使用與進入 ALPHA3 本身相同的患者族群，將使我們能比較：在 ALPHA3 中的 MRD 陽性患者之結果，與 MRD 陰性患者在觀察性隊列中的結果。也就是說，這將讓我們能以前瞻性的方式，進一步刻畫該檢測本身的表現。

Tyler Van Buren, TD Cowen.

Tyler Van Buren，TD Cowen。

Congratulations on your first call as CEO, Zach, and I appreciate the efficient prepared remarks. I guess given the acceleration of site activation by six months, is it possible that the interim EFS analysis could occur earlier than the guided mid-2027 timeline?

恭喜你以 CEO 身分主持第一次電話會議，Zach，也感謝你們精簡有效的事先準備發言。我想問的是，鑑於據點啟用時間加速了六個月，期中 EFS 分析是否有可能早於你們指引的 2027 年年中時程發生？

Thanks for the question, Tyler, and thanks for the congratulations. It's a thrill to be CEO and it's an honor. So getting to your question, so we are currently maintaining guidance that the EFS should occur at roughly the same time as previously guided. We are just moving to try to accelerate the enrollment of the study and of course working very hard to bring on as many sites for the reasons stated in the prepared remarks. But at this time we're not making any adjustments to the expectation of data availability.

謝謝你的問題，Tyler，也謝謝你的祝賀。能擔任 CEO 令人振奮，也是一種榮幸。回到你的問題，我們目前仍維持指引：EFS 大致會在先前所指引的時間點發生。我們正在做的是加速研究的入組，當然也非常努力地基於事先準備發言中提到的原因，盡可能啟用更多據點。但就目前而言，我們不會調整對資料可得時間的預期。

Salveen Richter, Goldman Sachs.

Salveen Richter，高盛（Goldman Sachs）。

Hey, this is Mark on for Salveen. Thanks so much for taking our question and congrats on the progress. It was good to see the enrollment for ALPHA3 post the interim data. Could you give us a breakdown of enrollment cadence across academic versus community sites? Is the expectation still that it's going to be 1/3 community and 2/3 academic and what feedback are you hearing from the community physicians?

嗨，我是 Mark，代替 Salveen。非常感謝讓我們提問，也恭喜你們的進展。很高興看到 ALPHA3 在期中資料之後的入組情況。你們能否拆解一下學術中心與社區據點的入組節奏？是否仍預期 1/3 來自社區、2/3 來自學術中心？另外，你們從社區醫師那邊聽到哪些回饋？

Without getting too specific here, I would say that the interest continues to be very high and growing in both the academic corners as well as the community corners. I would say that, that the surge of interest that we did see after the interim data really was pretty balanced between the two. We had some pretty big names centers reach out to try to join. And then we've got quite a number of community practices that also ask to join.

在不談得過於具體的前提下，我會說學術端與社區端的興趣都持續非常高，且仍在升溫。我也會說，我們在期中資料之後看到的那波興趣激增，在兩者之間其實相當均衡。有一些相當知名的中心主動聯繫希望加入；同時也有相當多的社區診所/醫療實務單位詢問加入。

So as far as how the patients break down in terms of where they come from, we actually have, I don't know if we've stated previously that it's about a third is expected. That's what we did see in the interim futility analysis. analysis, which was a very great outcome for us. I think that if we can maintain that or even bring it closer to parity in the final analysis, that would be something that we would be interested in doing. And that really does, I think, capture the last part of your question, which I believe was around what we're hearing from the various docs about the program.

至於患者來源的拆分，我們其實有——我不確定我們之前是否提過——大約預期三分之一會是如此。這也是我們在期中無效性（futility）分析中所看到的結果，對我們而言是非常好的成果。我認為如果我們能維持這個比例，甚至在最終分析中把它拉近到更接近對等，那會是我們有興趣達成的方向。而這也確實呼應你問題的最後一部分，我理解你是在問我們從不同醫師那裡對該計畫聽到的回饋。

I think everything that we heard early on when we launched the study and even before that when we were just talking about it with sites is that the community practices view this as really the best and first true opportunity to access CAR-T for their patient populations. And the academicians, on the other hand, you know, are very excited about, you know, cutting edge technologies, serving their patients in ways that improve the benefit-risk profile, ideally preventing relapse, which everybody universally agrees is a bad outcome.

我認為，我們在研究啟動初期聽到的所有回饋，甚至在那之前、當我們只是與各研究中心討論時就聽到的是：社區醫療機構（community practices）認為，這真的是他們為其病患族群取得 CAR-T 治療的最佳、也是第一個真正的機會。另一方面，學術醫療機構（academicians）則對前沿技術感到非常興奮，並希望以能改善效益—風險概況的方式來服務病患，理想情況下能預防復發，而大家普遍一致認為復發是一個不良結局。

So, across the board, we continue to hear very strong conviction that this strategy is excellent for patients, and then from the community practices specifically, enthusiasm around gaining access to CAR T, which has been out of their reach from the beginning.

因此，整體而言，我們持續聽到非常強烈的信念，認為這項策略對病患非常好；而就社區醫療機構而言，特別是對於能取得 CAR T 的機會感到振奮，因為從一開始這一直是他們難以觸及的治療。

Samantha Semenkow, Citi.

Samantha Semenkow，花旗（Citi）。

Zach, let me add my congratulations on your first call as CEO. So just another one on ALPHA3. As we look forward to the interim EFS analysis mid-next year. Just wondering how we should think about that analysis in terms of the potential for overwhelming benefit to be demonstrated. If the interim MRD assessment that we saw is repeatable for with more patients. How likely is that to translate into a stat-sig benefit on EFS at the interim analysis? Thank you.

Zach，讓我也祝賀你首次以執行長身分主持電話會議。我再問一題關於 ALPHA3。展望明年年中將進行的期中 EFS 分析，我想了解我們應如何看待該分析在顯示「壓倒性效益」（overwhelming benefit）方面的可能性。如果我們看到的期中 MRD 評估結果在更多病患中可重複出現，那有多大可能在期中分析時轉化為 EFS 的統計顯著（stat-sig）效益？謝謝。

Thanks, Samantha, and it's a great question. So, as we went into some detail when we released the data in April, the strong MRD clearance data that we observed we did think was quite positive and gave us some very positive views on the potential outcome of the study, either at the interim EFS or at the primary analysis. We also detailed that because of the way that we've allocated the alpha between those two EFS analyses, that it would require overwhelming efficacy to achieve statistical significance at the midway point there at the EFS, the interim EFS analysis.

謝謝你，Samantha，這是個很好的問題。正如我們在 4 月發布數據時已較詳細說明，我們觀察到的強勁 MRD 清除（clearance）數據確實相當正面，也讓我們對研究結果的潛在走向抱持非常正向的看法，無論是在期中 EFS 或主要分析時。我們也說明過，由於我們在兩次 EFS 分析之間分配了 alpha（顯著性水準），因此要在中途的期中 EFS 分析達到統計顯著，必須呈現壓倒性的療效（overwhelming efficacy）。

You know, we can't really go into further detail around, you know, whether about how we're thinking about the likelihood of that statistical significance, except I will reiterate that prior studies such as the, the TRANSFORM study of Breyanzi illustrated that a 24% MRD clearance differential between the CAR T and the transplant arm translated into a greater than 60% improvement in the EFS between those two arms. So a very, very positive outcome there on a comparatively lesser differential in the MRD clearance rate.

你知道，我們無法再進一步細談我們如何評估達到統計顯著的可能性；不過我會重申，先前研究例如 Breyanzi 的 TRANSFORM 研究顯示：CAR T 與移植組之間 24% 的 MRD 清除差異，轉化為兩組之間 EFS 超過 60% 的改善。也就是說，在相對較小的 MRD 清除率差異下，就能看到非常、非常正面的 EFS 結果。

So we remain very excited about the potential for a positive outcome here, but going into any further detail around how that might play out at the EFS analysis that is currently planned for middle of next year. I don't want to get too far ahead of myself on that one.

因此，我們仍對此處出現正面結果的潛力感到非常興奮；但就明年年中目前規劃的 EFS 分析可能如何發展而言，我不想在這點上說得太超前。

Matt Phipps, William Blair.

Matt Phipps，William Blair。

Hey team, this is Josh on for Matt. Thanks for taking my question and congrats on such a good quarter. So I had a question on the RESOLUTION readout as it approaches. We were wondering what kind of data and the level of granularity that we should expect from the readout later this year.

各位好，我是代替 Matt 的 Josh。謝謝讓我提問，也恭喜本季表現非常好。我想問的是，隨著 RESOLUTION 的讀出（readout）臨近，我們想了解今年稍晚的讀出中，預期會看到什麼樣的數據，以及數據細緻程度（granularity）會到什麼程度。

Thanks, Josh. So for the RESOLUTION trial, the data that is -- the data readout that we're currently planning for quarter 4 of this year, we expect to share clinical and translational data. I'll reiterate what was contained in the prepared remarks that we continue to be very pleased with the way enrollment is going. At the last call last quarter, we announced that we had treated nine patients in both the LD and non-LD containing arms. We have continued to see very robust demands to put patients into the study, so we should have a nice number of patients by the time we share that data in quarter 4, and then that will feature, of course, safety and efficacy outcomes as well as the translational findings.

謝謝你，Josh。關於 RESOLUTION 試驗，我們目前規劃在今年第 4 季進行的數據讀出，預期會分享臨床與轉譯（translational）數據。我再重申一下事先準備講稿中的內容：我們對入組（enrollment）的進展仍然非常滿意。上一季的電話會議上，我們宣布在含 LD 與不含 LD 的兩個組別中各治療了 9 位病患。我們持續看到將病患納入研究的需求非常強勁，因此到第 4 季分享數據時，應該會有相當不錯的病患數量；屆時當然會包含安全性與有效性結果，以及轉譯研究發現。

Cha Cha Yang, Jefferies.

Cha Cha Yang，Jefferies。

This is Cha Cha on for Roger. Congrats on the quarter as well. Just a question on the 329 trial with the data coming in fourth quarter. Just wondering if your guidance has changed in terms of the dose groups that you're going to announce. Are we still expecting the 20 million, 40 million and 80 million doses or is there any change?

我是代替 Roger 的 Cha Cha。本季也恭喜你們。想問一題關於 329 試驗，數據將在第 4 季出來。我想了解你們在將要公布的劑量組別方面，指引是否有改變？我們仍預期是 2,000 萬、4,000 萬與 8,000 萬的劑量，還是有任何變動？

Thank you, Cha Cha. So those are indeed the first three dose levels or the first two dose levels. We also will be dosing patients with 80 million. And this, there are additional doses above that are contemplated within the protocol. So as far as we get in that dose escalation, that will be the day. data that we share, but at least those three dose cohorts, 20 million, 40 million and 80 million, will be included.

謝謝你，Cha Cha。是的，那些確實是前幾個劑量水準（前兩個劑量水準），我們也會對病患給予 8,000 萬劑量。此外，方案（protocol）中也規劃了高於此的其他劑量。至於我們在劑量遞增（dose escalation）能推進到哪一步，將取決於我們屆時分享的數據；但至少這三個劑量隊列（cohorts）——2,000 萬、4,000 萬與 8,000 萬——都會納入。

Jack Allen, Baird.

Jack Allen，Baird。

Congrats on the progress over the quarter. I want to extend my congratulations to Zach on the new role. Really great to see you on the quarterly call here. My question is around the RMAT and Fast Track designations that you were able to secure over the course of the quarter. My understanding is that for RMAT specifically, there's a need to share clinical data when available with the FDA, and I'm just curious if you could provide any more context around what data was shared with the FDA. Was it really the April MRD data?

恭喜你們本季的進展。我也想恭喜 Zach 擔任新職務，很高興在季度電話會議上看到你。我的問題是關於你們在本季取得的 RMAT 與快速通道（Fast Track）資格認定。據我了解，特別是 RMAT 需要在可取得時與 FDA 分享臨床數據；我想請你提供更多背景：你們與 FDA 分享了哪些數據？主要就是 4 月的 MRD 數據嗎？

Or were there additional clinical data that were shared with the FDA? And then also kind of in the same vein, what aspects of the data set were most intriguing from the FDA's perspective? Was it the efficacy? Was it the safety? Or was it a combination of the two? Any context you can provide would be very helpful.

還是有另外分享其他臨床數據？另外同樣延伸來問，從 FDA 的角度來看，這份數據集中哪些面向最吸引他們？是有效性？是安全性？還是兩者的組合？你能提供的任何背景都會很有幫助。

Thanks, Jack. Yes, we were thrilled to receive those designations. RMAT, as you point out, is it does in fact require clinical data. It's very similar to breakthrough therapy designation. And so the clinical data that we provided was derived from that interim analysis that we shared back in April. And of course, what we share with regulators, generally speaking, is quite a bit more extensive than what is shared publicly outside of the company. And so this was a complete briefing package that went into all the information. available detail that we had. Again, EFS at the time, the actual events were blinded and they remained blinded to us. So this was really focused on the MRD results, but additional detail around the MRD was provided to the FDA and of course, an exhausted safety package also.

謝謝你，Jack。是的，我們很高興獲得這些認定。正如你指出的，RMAT 的確需要臨床數據，且與突破性療法認定（breakthrough therapy designation）非常相似。因此，我們提供的臨床數據源自我們在 4 月分享的那次期中分析。當然，一般而言，我們與監管機構分享的內容會比對外公開的資訊更為完整與深入。因此，這是一份完整的簡報資料（briefing package），涵蓋我們所掌握的所有可用資訊與細節。再次說明，當時的 EFS 事件（events）是盲態（blinded）的，且至今我們仍無法得知；因此這份資料主要聚焦於 MRD 結果，但也向 FDA 提供了更多關於 MRD 的額外細節，當然也包含一份詳盡的安全性資料包（safety package）。

In the FDA's decision, to award RMAT or not, they generally don't go into details about which aspect of the package was most enticing to them or most influential in their decision, but just generally that number one, that the disease under study, in our case MRD-positive large B-cell lymphoma represents an unmet medical need, which I really want to highlight as a pretty important thing for them to have pointed out, that this trial and this data set was even eligible for RMAT designation was predicated on that very fact, that MRD positivity is an unmet need. And then critically, of course, that MRD... Based on the data that they reviewed, Cema-Cel has the potential to meet that unmet medical need. So for those reasons, they decided to give us RMAT, but any further granularity, they did not provide.

至於 FDA 是否授予 RMAT 的決定，他們通常不會詳細說明是資料包中的哪個面向最吸引他們或對決策影響最大；但一般而言，第一是研究中的疾病領域——以我們為例，MRD 陽性的大 B 細胞淋巴瘤——代表一項未被滿足的醫療需求（unmet medical need）。我想特別強調，FDA 指出這點相當重要；本試驗與這份數據集之所以有資格獲得 RMAT 認定，正是基於這個事實：MRD 陽性是一項未被滿足的需求。其次也是關鍵的是，MRD……根據他們審閱的數據，Cema-Cel 具有滿足該未被滿足醫療需求的潛力。因此基於這些原因，他們決定授予我們 RMAT；但更進一步的細節，他們並未提供。

John Newman, Canaccord.

John Newman，Canaccord。

Congrats on the excellent progress. The question is, given the very impressive pace of enrollment for ALPHA3 and the increased target of enrollment sites to 100 by the end of the year. Are you open to the possibility of enrolling additional patients beyond the current target?

恭喜你們取得非常出色的進展。我的問題是，鑑於 ALPHA3 的入組速度非常令人印象深刻，且你們將今年年底前的入組中心目標提高到 100 家。你們是否願意考慮在目前目標之外再入組更多患者？

Thanks, John. The short answer is we are going to try to find as many ways that we can in the context of an ongoing study to offer enrollment to patients who meet the eligibility criteria for ALPHA3. Within the confines of ALPHA3 as written, the target is the target, 220 patients randomized into the two arms and generally speaking you don't want to go much above that until data is available to suggest a benefit-risk ratio that is permissive of over-enrollment. However, if additional opportunities along the way present themselves to add cohorts or explore other nuances within this broader field. those things will be considered in due time. But as the time sits right now, our target is 220.

謝謝你，John。簡短的回答是：在正在進行的研究框架下，我們會盡可能尋找各種方式，讓符合 ALPHA3 入組資格標準的患者都有機會入組。在 ALPHA3 方案既定的限制內，目標就是目標——220 名患者隨機分配至兩個組別；一般而言，在尚未有數據顯示其獲益—風險比允許超額入組之前，你不會希望超出太多。不過，如果在過程中出現額外機會，讓我們能新增隊列或探索這個更廣泛領域中的其他細微面向，這些都會在適當時機納入考量。但就目前而言，我們的目標是 220 人。

Luca Issi, RBC CM.

Luca Issi，RBC CM。

Adding our congrats to Zach and team on successful transition This is Cassie for Luca. Quick question on the 329. As Zach, you mentioned that dosing started for the lymphodepletion arm. Are you hearing any early anecdotes for CAR T expansion or persistence in patients treated with cyclophosphamide? And what positive signs are you looking for here at the 4Q update for this specific arm? Should we be thinking non-inferior or any specific benchmark. Any color, they're much appreciated.

我們也要向 Zach 和團隊成功完成交接致上恭喜。我是代替 Luca 的 Cassie。關於 329 有個簡短問題。Zach，你提到淋巴清除（lymphodepletion）組別已開始給藥。你們是否聽到任何早期的個案回饋，顯示在使用環磷醯胺（cyclophosphamide）治療的患者中，CAR T 的擴增或持續性（persistence）如何？另外，在第四季更新時，你們針對這個特定組別在尋找哪些正向訊號？我們應該以「不劣性」來思考，或有任何特定基準嗎？若能提供一些補充說明，將非常感謝。

Thanks, Cassie. So, you know, we were, as all Phase 1, first in human studies are, they are primarily a safety trial. So this is why we started a low dose and go up, and really we're monitoring most closely the safety outcomes and then making decisions about whether the dose escalate, dose expand. at additional cohorts, what have you.

謝謝你，Cassie。你知道，正如所有第一期、首次人體（first-in-human）研究一樣，它們主要是安全性試驗。因此我們從低劑量開始再往上調，並且我們最密切監測的是安全性結果，然後再據此決定是否進行劑量遞增、劑量擴展、增加其他隊列等等。

So we are collecting all of the safety information and we meet as a team with outside advisors prior to dose escalation. So that is the most important and comprehensive data package that we review in real time. We obviously are in close contact with the investigators around the efficacy and so, you know, as in previous statements, we've talked about encouraging signs of activity in that program and so, you know, I'll reiterate that now here is that we continue to have very robust interest and demand from investigators and patients to come in. on what we're seeing so far.

因此我們正在收集所有安全性資訊，並且在每次劑量遞增之前，我們都會與外部顧問一起以團隊形式開會。所以這是我們即時審閱的最重要、也最完整的一套資料包。我們當然也與研究者就療效保持密切聯繫；如同先前的說法，我們談到過該項目出現令人鼓舞的活性訊號，所以我在此再次重申：基於目前所見，我們持續看到研究者與患者對於參與試驗有非常強勁的興趣與需求。

As far as the translational data goes, those data are developed sort of in parallel and typically in batches. But so we do not, you know, we're not in a position to comment on the translational findings here today, just that we will be including those findings in the upcoming fourth quarter data release.

至於轉譯（translational）數據，這些數據通常是並行產出，且多半以批次方式整理。因此，我們今天不便就轉譯研究的發現做出評論；只能說，我們會在即將發布的第四季數據中納入這些發現。

Reni Benjamin, Citizens.

Reni Benjamin，Citizens。

Zach, congratulations on the new role. I guess I jumped in late. I hope this hasn't already been asked, but I'm interested in the competitive landscape as it continues to evolve and how you guys are kind of thinking about things and managing it, in particular, you know, not just the frontline study for autology CAR-T's that are being evaluated but also the recent Legend in vivo CAR-T data. I would love to kind of get your thoughts as to how you manage these things.

Zach，恭喜你擔任新職務。我想我加入得有點晚，希望這題之前還沒被問過。我想了解競爭格局持續演變之下，你們如何思考並加以管理；特別是，不僅是正在評估的自體（autologous）CAR-T 一線研究，還包括近期 Legend 的體內（in vivo）CAR-T 數據。我很想聽聽你對於你們如何應對這些情況的看法。

Thanks, Reni, for the question and for the congrats. So, great question. Thanks for asking it. It had not been asked prior to you joining, so good opportunity for me to dive in a little bit on that. So, obviously, we monitor the competitive landscape across our portfolio very, very carefully. And one of the things that we've enjoyed and continue to enjoy, I believe, is a pretty well protected place within this first line consolidation for ALPHA3. Nobody else has entered this space explicitly in that way yet. And the upfront, the first line studies that are ongoing, you mentioned CAR-T, but of course there's other specific pivotal studies as well.

謝謝你，Reni 的提問，也謝謝你的祝賀。這確實是個好問題，謝謝你提出來。在你加入之前還沒有人問到，所以也讓我有機會稍微深入談一下。很明顯地，我們在整個產品組合範圍內都非常、非常仔細地監測競爭格局。我認為我們一直以來、也仍然享有的一點是：在 ALPHA3 的一線鞏固（first line consolidation）這個定位上，我們有相當良好的保護性；目前還沒有其他人以同樣方式明確進入這個領域。至於你提到的前線、一線研究，除了 CAR-T 之外，當然也還有其他特定的關鍵性（pivotal）研究正在進行。

You know, we've looked at this very carefully both through conversations with PIs and investigators that are involved in the studies and those that are not. And then we've also performed some fairly extensive blinded market research. And our conclusion from that, those ongoing frontline studies is that they'll actually have a fairly minimal impact on the overall rate of MRD positivity in the immediate post-frontline setting. And that's primarily because both the CAR T cells and the bispecifics tend to carry a fairly significant toxicity profile. They're a bit cumbersome. some for patients and with some of them needing step-up dosing and even prospective hospitalization just to administer the therapy.

你知道，我們透過與參與這些研究的主要研究者（PI）與研究人員，以及未參與者的對話，對此做了非常審慎的評估；同時我們也進行了相當廣泛的盲測市場研究（blinded market research）。我們從這些前線研究得到的結論是：它們對於前線治療後、緊接著的整體 MRD 陽性率影響其實相當有限。主要原因在於，無論是 CAR T 細胞或雙特異性抗體（bispecifics），往往都伴隨相當顯著的毒性特徵；使用上也較為繁瑣。對部分患者而言，其中一些療法需要階梯式加量（step-up dosing），甚至需要預先住院才能施打治療。

So this is largely, in my view and in the view of the respondents to our study, will probably be reserved for select patients and select centers. So by and large, being that most patients, 80% or more, are treated in the community practices, the MRD rate is likely to stay pretty much where it is, primarily driven by outcomes following R-CHOP and R-Pola-CHP.

因此在我看來、也在我們研究受訪者的看法中，這些療法很可能只會保留給特定患者與特定中心。整體而言，鑑於大多數患者（80% 或以上）是在社區診所接受治療，MRD 比例很可能大致維持在目前水準，主要仍由 R-CHOP 與 R-Pola-CHP 治療後的結果所驅動。

With respect to the question around in vivo, And my view on this, and I think this has been validated through several conversations I've had, is that obviously an extremely exciting platform for the field and for patients, but likely I believe it will primarily suffice to replace autologous CAR T in the relapsed refractory setting, again pointing primarily to the toxicity profile, at least in the early days here, unless that gets markedly better, most community oncologists are not going to be enthusiastic about administering a large dose of active viral particles into patients during a busy clinic afternoon.

至於你問到的體內（in vivo）部分，我的看法是——而且我認為這也已透過我進行的多次對話得到驗證——這顯然是一個對整個領域與患者都極其令人振奮的平台；但我相信它主要會用來取代復發／難治（relapsed refractory）情境下的自體 CAR T，原因同樣主要指向其毒性特徵。至少在早期階段，除非毒性顯著改善，否則多數社區腫瘤科醫師不會熱衷於在忙碌的門診下午，向患者體內注入大量具有活性的病毒顆粒。

So, it feels like this is an opportunity for really, an off the shelf CAR T being available to community oncologists. They can give it in their infusion clinics over five minutes and the patients can be reasonably assured to go home without having much toxicity. At least that's the intention of ALPHA3. So clearly a lot of activity both upstream from us as well as downstream from us with the in vivo, but we think we're pretty well protected here right in the middle.

因此，這看起來是一個機會：讓社區腫瘤科醫師也能取得真正的現成（off-the-shelf）CAR T。他們可以在輸注門診用五分鐘完成給藥，而患者也能相對有把握地回家、且不會出現太多毒性——至少這就是 ALPHA3 的初衷。所以很明顯地，無論是在我們上游，或是在我們下游的體內（in vivo）方向，都有大量活動；但我們認為在中間這一段，我們的防護仍相當完善。

Thank you. That concludes our question-and-answer session. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may now log off and disconnect.

謝謝。問答環節到此結束。各位女士、先生，感謝您參與今天的電話會議。本次會議至此結束，您現在可以登出並斷線。