Adaptimmune Therapeutics PLC (ADAP) 2024 Q1 法說會逐字稿

All participants, please stand by. Your conference is ready to begin. Good morning, ladies and gentlemen, and welcome to the Adaptimmune Q1 2024 financial and business update conference call. I would now like to turn the meeting over to Ms. Juli Miller. Please go ahead, Ms. Miller.

請所有參加者等候。您的會議已準備好開始。早安，女士們、先生們，歡迎參加 Adaptimmune 2024 年第一季財務和業務更新電話會議。我現在想把會議交給朱莉·米勒女士。請繼續，米勒女士。

Good morning, and welcome to our conference call to discuss our first quarter 2024 financial results and business updates. I would ask you to review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call and other members of our management team will be available for Q&A.

早安，歡迎參加我們的電話會議，討論我們 2024 年第一季的財務表現和業務更新。我想請您閱讀我們今天早上新聞稿中前瞻性聲明的全文。我們預計在本次電話會議中做出的預測與實際結果可能會因多種因素而產生重大差異，包括我們向 SEC 提交的最新文件中概述的因素。我們的執行長 Adrian Rawcliffe 與我一起參加電話會議的準備部分，我們管理團隊的其他成員也將參加問答。

With that, I'll turn call over to Adrian. Ad?

這樣，我會將電話轉給阿德里安。廣告？

Thanks, Juli, and thanks, everyone, for joining us for our Q1 call. I plan to provide some brief comments before we go into Q&A. The comments are going to be brief because a couple of weeks ago, we held an Investor Day, and we provided a fairly comprehensive update on the regulatory status of Afami-cel as we move towards the producer date of the August 4.

謝謝 Juli，也謝謝大家參加我們的第一季電話會議。在我們進行問答之前，我計劃提供一些簡短的評論。這些評論將很簡短，因為幾週前，我們舉行了投資者日，隨著我們接近 8 月 4 日的生產日期，我們提供了有關 Afami-cel 監管狀況的相當全面的最新信息。

And we also talked about how important this is for the field as the first approved engineered TCR T-cell therapy for solid tumor indications. We also discussed our preparations for the commercial launch of a Afami-cel in some detail, and we said that we'd be ready to do this on approval of Afami-cel. And that this would be the beginning of a commercial sarcoma franchise that we feel has significant and underappreciated value.

我們也討論了作為第一個獲準用於實體瘤適應症的工程化 TCR T 細胞療法，這對於該領域有多麼重要。我們也詳細討論了 Afami-cel 商業推出的準備工作，並表示我們將在 Afami-cel 獲得批准後做好準備。這將是商業肉瘤特許經營權的開始，我們認為該特許經營權具有重大且未被充分認識的價值。

In this morning's press release, we provided a further update on the BLA progress and our head of late-stage development. Dennis Williams is here for the Q&A portion of this call. In short our interactions with the FDA are progressing as planned, and we're looking forward to our late cycle review meeting in the second half of this month. Thus far the FDA has not requested an AdCom or REMS program.

在今天早上的新聞稿中，我們提供了有關 BLA 進展和我們後期開發負責人的進一步更新。丹尼斯威廉斯 (Dennis Williams) 出席本次電話會議的問答部分。簡而言之，我們與 FDA 的互動正在按計劃進行，我們期待本月下半月的後期週期審查會議。到目前為止，FDA 尚未要求實施 AdCom 或 REMS 計劃。

We look forward to the labeling discussions and also to commercialization in due course, and I'm happy to confirm that our customer facing commercial and medical affairs team are now fully in place. Cintia Piccina, Chief Commercial Officer is here for the Q&A as well. As I said, we are on track to be ready to launch on approval. We have a focused team starting at 6 to 10 treatment centers and ramping up to approximately 30 in due course. And if you revisit the investor day presentation by Dr. McHale [at drupa], which is available on our website, you'll see that the expectations and anticipation for Afami-cel within the sarcoma community are very high.

我們期待著標籤討論以及適時的商業化，我很高興地確認我們面向客戶的商業和醫療事務團隊現已完全到位。商務長 Cintia Piccina 也出席了問答活動。正如我所說，我們正準備好在獲得批准後啟動。我們擁有一支專注的團隊，從 6 到 10 個治療中心開始，並在適當的時候增加到大約 30 個。如果您重溫 McHale 博士在德魯巴展會上的投資者日演講（可在我們的網站上取得），您會發現肉瘤界對 Afami-cel 的期望和期待非常高。

I think that sense of anticipation was reinforced by Philip Leider patient advocate and President of the Sarcoma Alliance who lost assistant to sarcoma. And he, I think, very eloquently highlighted the demand for novel therapies in this space. So we are scaling our manufacturing to be able to meet what we anticipate to be the launch volumes for Afami-cel in the second half of 2024. And in summary, all is on track for the launch of a Afami-cel on approval. And that's expected to round out the due for date in August and is highly anticipated by the sarcoma community. And obviously, we are very eager to get this product into the hands of this community that has worked so hard with us over the last decade to develop medicines for sarcoma.

我認為，因肉瘤而失去助手的病患權益倡導者兼肉瘤聯盟主席 Philip Leider 強化了這種期待感。我認為，他非常雄辯地強調了這個領域對新療法的需求。因此，我們正在擴大生產規模，以滿足我們預計 2024 年下半年 Afami-cel 的上市量。總而言之，Afami-cel 的上市已獲批准，一切都步入正軌。預計八月完成，這是肉瘤界高度期待的。顯然，我們非常渴望將這種產品交到這個社區手中，這個社區在過去十年中與我們一起努力開發肉瘤藥物。

Behind the Afami-cel, we are also progressing the development of lead to sell, and I'll point you towards a presentation of the interim data analysis from the pivotal IGNYTE-ESO trial in synovial sarcoma and MRCLS that we previewed at a high level last year. These data look very similar to afami-cel other than, of course, they are in both synovial sarcoma and myxoid round cell liposarcoma. And that will be presented at a platform presentation at ASCO by Dr. Sandra D'Angelo.

在 Afami-cel 的背後，我們也在推進銷售線索的開發，我將向您介紹滑膜肉瘤和 MRCLS 關鍵 IGNYTE-ESO 試驗的中期數據分析，我們在高水平上預覽了該試驗去年。這些數據看起來與 afami-cel 非常相似，當然，它們同時存在於滑膜肉瘤和黏液樣圓細胞脂肪肉瘤中。Sandra D'Angelo 博士將在 ASCO 的平台演講中介紹這一點。

This will be an important milestone for people's understanding and the de-risking of the cell therapy as we continue to move towards having a BLA in place in 2025 with anticipated approval, full SSL inside synovial sarcoma and MRCLS in 2026. You would have seen another press release with us this morning announcing that we've secured up to $125 million in debt financing with Hercules Capital for the first tranche of $25 million available on closing and the an additional $25 million available on afami-cel approval.

這將是人們理解細胞療法和降低細胞療法風險的一個重要里程碑，因為我們將繼續朝著 2025 年獲得預期批准的 BLA 邁進，並在 2026 年獲得滑膜肉瘤內的全面 SSL 和 MRCLS。今天早上您可能會看到我們發布的另一份新聞稿，宣布我們已經與Hercules Capital 獲得了高達1.25 億美元的債務融資，其中第一筆交易完成後可獲得2500 萬美元，另外2500 萬美元將在afami-cel 批准後獲得。

In addition, you will have seen that in Q1, we raised approximately $30 million of the ATM based on significant inbound inquiries. We've taken these steps to secure our financial position and have cash runway into late 2025. And with this runway, we have the funds necessary to execute on our priorities.

此外，您還會看到，在第一季度，我們根據大量入站查詢籌集了大約 3000 萬美元的 ATM 資金。我們已採取這些措施來確保我們的財務狀況，並在 2025 年底之前擁有現金跑道。有了這條跑道，我們就有了執行優先事項所需的資金。

The launch of afami-cel followed by lete-cel and also executing on the other pipeline projects such as the Phase 2 trial with uza-cel or platinum resistant ovarian cancer. And Gavin Wood, our Chief Financial Officer is here for the Q&A as well.

afami-cel 上市後，lete-cel 上市，同時也執行其他管道項目，例如 uza-cel 或鉑金抗藥性卵巢癌的 2 期試驗。我們的財務長 Gavin Wood 也出席了問答環節。

So with that, I'd like to turn it over to the operator for questions. Operator?

因此，我想將其轉交給接線員詢問問題。操作員？

(Operator Instructions) Jonathan Chang, Leerink Partners.

（操作員說明）Jonathan Chang，Leerink Partners。

Hi, guys. Thanks for taking my questions. First question, can you talk about the impact of the debt agreement announced today on your cash runway guidance? I'm just trying to better understand what's assumed in the current cards.

嗨，大家好。感謝您回答我的問題。第一個問題，您能談談今天宣布的債務協議對您的現金跑道指引的影響嗎？我只是想更好地理解當前卡片中的假設。

So Gavin?

那麼加文?

Yeah, hi, Jonathan. So a number of things have changed since we last gave guidance at the start of the year. But clearly, we had the termination of the Genentech agreement, and we're still working through the terms of that termination agreement. We've made significant progress on Afami-cel. And the broader development of the broader sarcoma franchise. As I've just mentioned, we've raised money under the ATM and we've also executed a new debt facility with Hercules, putting all those moving pieces together we thought it prudent bringing our cash runway by about close to like 2025.

是的，嗨，喬納森。因此，自從我們上次在年初提供指導以來，許多事情都發生了變化。但顯然，我們已經終止了基因泰克協議，我們仍在研究該終止協議的條款。我們在 Afami-cel 上取得了重大進展。以及更廣泛的肉瘤專營權的更廣泛發展。正如我剛才提到的，我們已經透過ATM 籌集了資金，並且還與Hercules 執行了一項新的債務融資，將所有這些移動部件放在一起，我們認為謹慎的做法是在2025 年左右實現我們的現金跑道。

Got it. And what assumptions are there for how much of the debt is being drawn down?

知道了。對於減少多少債務有什麼假設？

As we drew down $25 million close and this $25 million available at that's due for date.

當我們結束時提取了 2500 萬美元，這 2500 萬美元到期了。

Got it. And then second question, just can you help set expectations for the upcoming ASCO IGNYTE-ESO presentation. Thank you.

知道了。第二個問題，您能否協助設定即將舉行的 ASCO IGNYTE-ESO 演示的期望。謝謝。

Dennis, do you want to take that.

丹尼斯，你想接受這個嗎？

Yeah, sure. So from for the ASCO presentation, we're going to be presenting results on the interim analysis of the pivotal IGNYTE-ESO trial. So this is a 45 patients, and that trial followed for at least six months, almost evenly comprised of patients with synovial sarcoma and myxoid round cell liposarcoma. So we'll present the efficacy data and safety data that were available at that interim analysis.

好，當然。因此，在 ASCO 演示中，我們將展示關鍵 IGNYTE-ESO 試驗的中期分析結果。這是一個 45 名患者的試驗，該試驗持續了至少六個月，幾乎均勻地由患有滑膜肉瘤和黏液樣圓細胞脂肪肉瘤的患者組成。因此，我們將提供中期分析中可用的功效數據和安全性數據。

Got it. Thanks for taking my questions.

知道了。感謝您回答我的問題。

[Thank you, Jonathan].

[謝謝你，喬納森]。

Marc Frahm, TD Cowen.

馬克·弗拉姆，TD·考恩。

Thanks for taking the questions. First, as like said, you're giving details along the way of the FDA review and late-cycle review meeting coming up. Can you review what your closure strategy is going to be around some of the information that may be conveyed or going by you guys at the meeting.

感謝您提出問題。首先，如前所述，您將提供 FDA 審查和即將召開的後期審查會議的詳細資訊。您能否回顧一下您的結束策略將圍繞您在會議上可能傳達或討論的一些訊息進行。

So why don't I take a stab at that. So we're actually running pretty hard towards the but the late-cycle review meeting and the discussions where on labeling that we anticipate and on post marketing commitments, yeah, we were going to be focused on that in the run-up to the due for date. And I think if there's anything material that comes out from that, we will be disclosing other ways. We're pushing hard for the discussions with the agency and getting to do for and then being able to launch.

那我為什麼不嘗試呢？因此，我們實際上正在努力爭取後期審查會議和討論，其中涉及我們預期的標籤和營銷後承諾，是的，我們將在到期前將重點放在這一點上。我認為，如果從中得出任何材料，我們將透過其他方式進行揭露。我們正在努力推動與該機構的討論，並做好準備，然後才能啟動。

Okay. As you get into the labeling discussions, I mean, what do you view as the major trends and questions need to be answered about new indications and things like and things to include or not include in the label?

好的。當您進入標籤討論時，我的意思是，您認為關於新適應症以及標籤中包含或不包含的內容的主要趨勢和需要回答的問題是什麼？

Yeah. So this is Dennis Williams. I think is like I mentioned at the Investor Days. Some of this really comes down to individual wording that goes in the label, like; for example, I'll give the default and the example I gave at Investor Day. How we manage cytokine release syndrome, right? So we'll be talking about how that information should be structured in the label, how we give tislelizumab or how we would recommend that product and for what grade CRS.

是的。這是丹尼斯·威廉斯。我想就像我在投資者日提到的那樣。其中一些實際上歸結為標籤中的個別措辭，例如；例如，我將給出預設值和我在投資者日給出的範例。我們如何管理細胞激素釋放綜合徵，對嗎？因此，我們將討論如何在標籤中建立這些資訊、我們如何給予替雷利珠單抗或我們如何推薦該產品以及 CRS 的等級。

So sometimes it's really about the finer points of how in other words are in the label. We have had no discussions to date with the FDA around the indication statement. And we feel very confident that the indication statement we proposed is more or less. A few words is what we're going to end up with at the end of this review.

所以有時這實際上是關於標籤中的細節，換句話說。迄今為止，我們尚未與 FDA 就適應症聲明進行任何討論。我們對我們提出的指示說明或多或少感到非常有信心。在本次審查結束時，我們將要說幾句話。

Okay, thanks very helpful.

好的，謝謝非常有幫助。

Thanks, Marc.

謝謝，馬克。

Tony Butler, Rodman & Renshaw.

東尼巴特勒、羅德曼和倫肖。

Yes, good morning. I'm very respectful of the focus on Afami-cel and to lete-cel on Larry. But I wanted to ask about uza-cel and whether or not at least in the calendar year, there was any anticipation of a follow up on SURPASS-3, either in ovarian or in the Stage 1 with bladder, et cetera. Thanks very much.

是的，早安。我非常尊重 Afami-cel 和 Lete-cel 對 Larry 的關注。但我想詢問 uza-cel 的情況，以及是否至少在這一年中，是否有對 SURPASS-3 的後續行動的預期，無論是在卵巢中還是在膀胱的第一階段，等等。非常感謝。

So what I wanted to cover that with what we're thinking about uza-cel. But the past three in platinum resistant ovarian cancer that's designed with the potential to end up as a registrational trial. And therefore, we won't be putting out any data on that until we have at least enrolled all of the patients in that trial. There are interim reads for futility analysis, but we won't be communicating the data until we've at least in mode all of the patients in that trial, which we anticipate being a 2025 event on full enrollment of that trial.

所以我想用我們對 uza-cel 的想法來涵蓋這一點。但過去三項針對鉑類抗藥性卵巢癌的研究有可能最終成為一項註冊試驗。因此，在我們至少將所有患者納入試驗之前，我們不會發布任何相關數據。有無效性分析的臨時讀數，但在我們至少對該試驗中的所有患者進行模式之前，我們不會傳達數據，我們預計該試驗將在 2025 年全面入組。

So with respect to the other indications that we've now focused down on to ovarian cancer in the past three and the two other indications in head and neck and bladder. And the objective is to gather data in a Phase 1 setting in a range of patients and potentially in combination with checkpoint inhibitors as well. And what we've said there is we anticipate giving an update on the basis of the data that we've gathered at the tail end of this year about how we anticipate moving forward with those, which would include the data themselves.

因此，關於過去三年我們現在關注的其他適應症，以及頭頸癌和膀胱癌的其他兩個適應症，我們現在專注於卵巢癌。目標是收集一系列患者的第一階段數據，並可能與檢查點抑制劑合併使用。我們已經說過，我們預計會根據今年年底收集的數據提供更新，說明我們預計如何推進這些工作，其中包括數據本身。

Thanks very much.

非常感謝。

Thanks, Tony.

謝謝，托尼。

Graig Suvannavejh, Mizuho Securities.

Graig Suvannavejh，瑞穗證券。

Good morning, thanks for taking my question and congrats on all the progress. And I'm just wanted to go back to the FDA review process and in particular, also in light of the great analyst or an investor that you had done in Chile. Just curious if there have been any other perhaps progress are -- maybe any additional inspections by FDA on the manufacturing facilities. Do you expect any and other visits prior to approval, just wanted to get a better handle on how things were shaping up there as it relates to in our CMC manufacturing and your facilities?

早安，感謝您提出我的問題並祝賀所有的進展。我只是想回顧一下 FDA 的審查流程，特別是考慮到您在智利做過的偉大分析師或投資者。只是好奇是否還有其他可能的進展——也許 FDA 對生產設施進行了任何額外的檢查。您是否期望在批准之前進行任何其他訪問，只是想更好地了解與我們的 CMC 製造和您的設施相關的情況？

Hi, this is Dennis Williams again. So yes, I think at this point, all the inspections are expected to be completed, right? So we both manufacturing facilities that we utilize our own manufacturing for Afami-cel drug product, the lentiviral manufacturing facility that we have for the vector that supplies for drug product has been inspected. That's had a good outcome. And all the clinical trial sites that were inspected also are completed. They all had a very good outcome. And as I mentioned during Investor Day, that than maybe our facility here from a GCP standpoint was also inspected. So at this point, we think all the inspections are complete. I guess there's always a scenario where another clinical site but could be inspected. But at this point, I think at this stage in the review, inspections are completed.

大家好，我又是丹尼斯威廉斯。所以是的，我認為此時所有檢查都應該完成，對嗎？因此，我們都利用自己的 Afami-cel 藥品生產設施，我們為藥品供應的載體所擁有的慢病毒生產設施已經過檢查。這樣就有了一個好的結果。目前已檢查的臨床試驗場地也已全部完成。他們都取得了非常好的結果。正如我在投資者日期間提到的，從 GCP 的角度來看，我們這裡的設施可能也受到了檢查。至此，我們認為所有檢查都已完成。我想總有一種情況可以檢查另一個臨床站點。但目前來看，我認為現階段的審查、檢查已經完成。

Okay. Thanks for that clarity. And just with regards to earlier comments made about not anticipating we're not expecting perhaps an AdCom or our REMS program. Maybe just on the latter with regards to revenues from a calendar perspective, is it something that discussion would naturally have happened by now? Or is it still part of a potential discussion between now and the PDUFA? Thank you.

好的。感謝您的清晰說明。關於之前關於不期待的評論，我們可能不會期待 AdCom 或我們的 REMS 計劃。也許只是從日曆角度來看後者的收入，現在自然會發生討論嗎？或者它仍然是現在與 PDUFA 之間潛在討論的一部分嗎？謝謝。

Yes, sure. So we did not submit a REMS in this BLA application. And we've had discussions with the FDA during the review. And I think at the time I had this discussion at Investor Day, the FDA review was ongoing and there was no decision about a REMS at that time and they certainly had not asked for one at that time. You're correct. That had a REMS been requested that time would have elapsed already that would have occurred within the few weeks of that mid-cycle meeting. I can just say in general, the conversations we've had with the FDA, we don't anticipate a REMS for this product.

是的，當然。因此，我們在此 BLA 申請中沒有提交 REMS。我們在審查期間與 FDA 進行了討論。我認為，當我在投資者日進行討論時，FDA 審查正在進行中，當時還沒有關於 REMS 的決定，他們當時當然也沒有要求這樣做。你是對的。如果要求 REMS，那麼時間就已經過去了，而這將在中期會議的幾週內發生。我只能說，總的來說，根據我們與 FDA 的對話，我們預計該產品不會有 REMS。

Okay, thank you. And maybe just the last question, if I could. Just if you could remind us all assuming an on-time approval, how we should be thinking about the shape of the uptake curve, particularly from a revenue perspective.

好的謝謝。如果可以的話，也許只是最後一個問題。如果您能提醒我們所有人假設按時批准，我們應該如何考慮採用曲線的形狀，特別是從收入的角度來看。

So why don't I touch on that, which is the -- what we basically guided to is that we've not given guidance on the on the specific numbers of patients that we anticipate coming through in the early part of the launch at what we have said is that it was important to understand that because this is an autologous product that's manufactured need to be screened for target to then manufacture them return to patients, whatever you think that uptake curve looks like it's essentially frame shifted by and we're guiding to about a quarter from -- so the first revenues from afami-cel would the first patients would not be dosed treated and the first revenues recognized until Q4 this year, even though we anticipate approval and we anticipate starting to enroll patients from the PDUFA date in August.

那麼，我為什麼不談一下這一點，我們基本上引導的是，我們沒有就我們預計在啟動初期會遇到的具體患者數量提供指導。一種自體產品，製造時需要篩選目標，然後將其製造回患者體內，無論您認為吸收曲線看起來如何，它本質上是框架移動的，我們是指導大約四分之一- 因此，afami-cel的第一筆收入將是第一批患者不會接受劑量治療，並且第一筆收入要到今年第四季度才能確認，儘管我們預計會獲得批准，並且我們預計會開始從PDUFA 招募患者日期在八月。

Great, Thank you.

太好了謝謝。

Thank you.

謝謝。

Michael Schmidt, Guggenheim.

邁克爾·施密特，古根漢。

Hi, this is Paul on for Michael. Thanks for taking our question. So on the Afami-cel launch, you talked about targeting about 6 to 10 sites for that early launch. But looking beyond this year, what's your current thinking on strategy for scaling up to all 30 ATC across the country and how many of those centers have had experience with afami-cel in the clinical trial setting?

大家好，我是麥可的保羅。感謝您提出我們的問題。因此，在 Afami-cel 發佈時，您談到了早期發布的目標是 6 到 10 個網站。但展望今年，您目前對擴大到全國所有 30 個 ATC 的策略有何想法？

So I'll ask Cintia to talk to that. Cintia?

所以我會請 Cintia 談談這個問題。辛蒂亞？

Thank you. Yes. So we are, as Adrian said, we are targeting about 6 to 10 sites during the launch period, meaning the first quarter after launch. And we are already starting to engage beyond those with the expectation to have up to the 30 sites available about 18 months after launch. Out of these 30 sites in total, 16 of them, which would be the priority sites have clinical experience with the afami-cel and some additional sites that are part of that they also have experience with lete-cel. So all of our 30, but 82 in the future of all of our clinical sites from lete-cel and afami-cel will be part of those 30. And again, we know noted those sites still the majority of the synovial sarcoma patients in the country.

謝謝。是的。因此，正如 Adrian 所說，我們的目標是在發布期間（即發布後的第一季）大約 6 到 10 個網站。我們已經開始參與超出預期的活動，預計在發布後 18 個月左右將有多達 30 個可用站點。在這總共 30 個站點中，其中 16 個站點（優先站點）擁有 afami-cel 的臨床經驗，另外一些站點也擁有 Lete-cel 的臨床經驗。因此，我們所有的 30 個臨床中心，但未來來自 lete-cel 和 afami-cel 的所有臨床中心的 82 個都將成為這 30 個中心的一部分。再次，我們知道這些部位仍然是該國滑膜肉瘤患者的大多數。

Great. Thanks for that. And maybe just a follow-up. As you look ahead to the launch. Can you give a sense of what metrics you're finding to disclose in the early months? You give a sense of how that launch is progressing there has been an area of focus for the entire launch for our advanced. Just curious if we can expect updates on number of patients identified versus use or if you're likely to provide more qualitative updates in the early months. Thank you.

偉大的。感謝那。也許只是後續行動。當你展望發射時。您能否介紹一下您發現在最初幾個月需要揭露哪些指標？您可以了解該發布的進展情況，我們高級版的整個發布都有一個重點領域。只是好奇我們是否可以期待有關已識別患者數量與使用患者數量的更新，或者您是否可能在前幾個月提供更多定性更新。謝謝。

That we plan on updating that at our next Q call.

我們計劃在下一次 Q 電話會議上更新這一點。

That's it. Thank you so much.

就是這樣。太感謝了。

Paul, thank you.

保羅，謝謝你。

Arthur He, H.C. Wainwright.

何亞瑟，H.C.溫賴特。

Hey, Ad and Team, this is Arthur from H.C. Wainwright. Thanks for taking my question. I guess I just had a broad picture question. So as we see the delta of industry moving to the autoimmune disease area, could you help educate us the potential from your platform aiming for the autoimmune disease? I know you guys are to focus on the launch, but just curious on the potential there. Thanks.

嘿，Ad 和團隊，我是來自 H.C. 的 Arthur。溫賴特。感謝您提出我的問題。我想我只是有一個廣泛的問題。因此，當我們看到產業三角洲正在轉移到自體免疫疾病領域時，您能否幫助我們了解您的平台針對自體免疫疾病的潛力？我知道你們會關注這次發布，但只是對那裡的潛力感到好奇。謝謝。

Sure. So as you've said, we are laser-focused on the launch. We have if you dig into the history of the company long enough, we have explored the opportunity to develop TCR targeted therapies for autoimmune disease, mostly focused on Tregs programs. But I think in the short, in the short-term, our focus is on obviously the launch of a afami-cel and the sarcoma franchise. But also in between that and the very long-term future in autoimmune and maybe other indications, just the massive unmet need that can be addressed with TCR T-cell therapies in the oncology space.

當然。正如您所說，我們全神貫注於此次發布。如果你深入研究公司的歷史足夠長的時間，我們會發現，我們已經探索了開發針對自體免疫疾病的 TCR 標靶療法的機會，主要集中在 Tregs 項目上。但我認為，短期內，我們的重點顯然是推出 afami-cel 和肉瘤系列。但在此與自體免疫以及其他適應症的長期未來之間，腫瘤學領域的 TCR T 細胞療法可以解決大量未滿足的需求。

And if you look at the rest of our pipeline. You'll see that as we over the coming years, we will very quickly move from a sarcoma only franchise with two products and [$400 million] of sales into much larger patient populations and that there's an opportunity with the uza-cel and obviously, ovarian bladder and head and neck getting beyond that with Prime, given the recent interesting data with that target. And with CD70, both of which are in the late preclinical pipeline and the opportunity there to address.

如果你看看我們其餘的管道。你會看到，在接下來的幾年裡，我們很快就會從僅擁有兩種產品和[4億美元]銷售額的肉瘤特許經營權轉向更大的患者群體，並且uza-cel 有機會，顯然，考慮到最近有關該目標的有趣數據，卵巢膀胱和頭頸部已經超出了 Prime 的範圍。至於 CD70，兩者都處於臨床前後期管道中，並且有機會解決。

100 over 100,000 patients that are currently dying from their indications with the right target and the right HLA type. And so when we see we see this in terms of Horizon's short-term sarcoma, longer-term, broaden that out making cell therapies potentially curative and mainstream across a broad range of tumors. And then taking cell therapies into other are the spaces of where patients could benefit in other non-oncology indications in the long-term.

超過 100,000 名目前因適應症而死亡的患者擁有正確的標靶和正確的 HLA 類型。因此，當我們看到 Horizo​​n 的短期肉瘤時，我們會看到這一點，從長期來看，擴大這一點，使細胞療法有可能治癒並成為廣泛腫瘤的主流。然後將細胞療法引入其他領域，從長遠來看，患者可以從其他非腫瘤適應症中受益。

Thanks for the color.

謝謝你的顏色。

Peter Lawson, Barclays.

彼得·勞森，巴克萊銀行。

Mr. Lawson, your line is open. You may proceed with your question.

勞森先生，您的電話接通了。你可以繼續你的問題。

Great, thanks for taking my question and thanks for the update. I wonder if you could talk around the turnaround time, time would take between approval book and the initial revenues as we can just think about the turnaround time, your end does that turnaround time within the hospitals and the patients in this. Any variables there we should be thinking about?

太好了，感謝您提出我的問題並感謝您的更新。我想知道您是否可以談談週轉時間，批准書和初始收入之間需要的時間，因為我們可以只考慮週轉時間，您的最終結果是醫院和患者的周轉時間。我們應該考慮哪些變數？

Cintia, do you want to talk to that?

Cintia，你想談談嗎？

Yes, absolutely. Yeah. So when we think about the turnaround time from the patient journey perspective, we need to consider that the patients when they identified the first step that they need, it should be tested for Italy and Meiji for which is a process that can take a few days. Then we go through the a freezes process, scheduling it freezes. And then when we receive the freeze material from manufacturing turnaround time, then that will be of about 30 days and then shipping it back to the to the sites.

是的，一點沒錯。是的。因此，當我們從患者旅程的角度考慮週轉時間時，我們需要考慮患者在確定所需的第一步時，應該在義大利和明治進行測試，這個過程可能需要幾天的時間。然後我們經歷凍結過程，調度它凍結。然後，當我們收到製造週轉時間的冷凍材料時，大約需要 30 天，然後將其運回現場。

So that's why launch the companion diagnostic tests to be approved, at the same time that's our expectation -- at the same time that afami-cel approved. So we would expect to see, as Adrian mentioned before, first patients dosed during the fourth quarter of the year.

這就是為什麼要啟動配套診斷測試並獲得批准，同時這是我們的期望 - 同時 afami-cel 也獲得了批准。因此，正如阿德里安之前提到的，我們預計將在今年第四季看到第一批患者接受給藥。

[Perfect]. Okay. Thank you. And then Part of the patients identified, and the increases were, what's the general timeline you expect around that? I imagine is fair amount of variability.

[完美的]。好的。謝謝。然後確定的部分患者以及增加的患者數量是，您預計的整體時間表是什麼？我認為存在相當大的可變性。

Yeah, hi, this is John. I am leading manufacturing. So the turnaround time from typical time from the collection of the [A freeze's] material until the release of their product to send it back to the site tends to range between four and six weeks.

是的，嗨，這是約翰。我領導製造業。因此，從收集 [A freeze 的] 材料到發布產品並將其發送回現場的典型週轉時間往往在四到六週之間。

Okay. Any other things we should be thinking about the front end and the back end there outside your control and in a sense, you get how long it takes patients to get through the funnel from being identified by diagnostic test, right? And then the other end of it gets the hospital willing actually to get (inaudible)

好的。我們應該考慮前端和後端的任何其他事情，這些事情超出了您的控制範圍，從某種意義上說，您知道患者需要多長時間才能通過診斷測試來識別，對嗎？然後它的另一端讓醫院願意真正得到（聽不清楚）

So couple of things to consider before will be patient identification the testing. Then depending on where these patients are, they have to be referred to a treatment center that can take a few days. Reimbursement is also something that will be checked at the very early part of the journey then from a freeze is all the way back to infusion. It's mostly straightforward. We could have potentially the patient condition getting or certain other things that are out of control. But then it's mostly a little bit more straightforward.

因此，之前需要考慮的幾件事是患者識別測試。然後，根據這些患者所在的位置，他們必須被轉診到治療中心，這可能需要幾天的時間。報銷也會在旅程的早期階段進行檢查，然後從冷凍一直回到輸液。這大部分都很簡單。我們可能會出現患者病情惡化或某些其他事情失控的情況。但接下來的事情就更加簡單了。

Got you. okay. On just final question, just around the SURPASS data later this year, we'll get head & neck and bladder just expectations around the number of patients we should see if what you regard as that positive comment on that status?

明白你了。好的。關於最後一個問題，圍繞今年稍後的 SURPASS 數據，我們將得到頭頸和膀胱的預期，大約是我們應該看到的患者數量，如果您認為對該狀態的積極評論是什麼？

Dannis?

丹尼斯？

Yeah, thanks. Yeah, we haven't guided to specific numbers that we would anticipate as it relates to patient dosing. And we have said that we -- that we anticipate having sufficient data to make directional decisions regarding both of those indications by the end of the year.

是的，謝謝。是的，我們還沒有指導我們預期的具體數字，因為它與患者劑量有關。我們已經說過，我們預計到今年年底將有足夠的數據來就這兩個跡像做出方向性決策。

Great. Thanks so much.

偉大的。非常感謝。

Thanks, Peter.

謝謝，彼得。

Thank you. We have no further questions registered at this time. I would now like to turn the meeting over to Mr. Rawcliffe.

謝謝。目前我們沒有進一步的問題。我現在想把會議交給羅克利夫先生。

So I thank you, everybody, for your time today. Thank you for your questions and look forward to seeing those of you ASCO who are attending. And look forward to updating you as we move towards approval and launch of afami-cel later on this year. Thanks a lot. Take care.

所以我感謝大家今天抽出時間。感謝您提出問題，並期待與參加 ASCO 的各位見面。我們將在今年稍後批准並推出 afami-cel，期待向您通報最新情況。多謝。小心。

Thank you. The conference has now ended. Please disconnect your lines at this time, and we thank you for your participation.

謝謝。會議現已結束。此時請斷開您的線路，我們感謝您的參與。