Adaptimmune Therapeutics PLC (ADAP) 2023 Q4 法說會逐字稿

Hello, and welcome to Adaptimmune fourth quarter and year end conference call and business update.

您好，歡迎參加 Adaptimmune 第四季和年終電話會議和業務更新。

I will now turn the call over to Juli Miller. Juli, please go ahead.

我現在將把電話轉給朱莉·米勒。朱莉，請繼續。

Good morning, and thank you for joining us. Welcome to our Q4 and full year 2023 update, and I refer you to our disclaimer here. As well as our forward-looking statements in this morning's press release. For the prepared portion of the call, Adrian Rawcliffe, our CEO, is with us and other members of our management team are available for Q&A.

早安，感謝您加入我們。歡迎閱讀我們的第四季和 2023 年全年更新，請參閱此處的免責聲明。以及我們在今天上午的新聞稿中的前瞻性聲明。對於電話會議的準備部分，我們的執行長 Adrian Rawcliffe 與我們在一起，我們管理團隊的其他成員也可以參加問答。

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

這樣，我會將電話轉給阿德里安。

Thanks Juli. Thanks everyone, for joining today. So, I plan today to recap the progress we made in 2023 and shared a little bit about our plans for 2024. I'll be focused primarily on afami-cel, which will be our first commercial product in our sarcoma franchise. 2023 was a year of transformation for Adaptimmune. We completed a corporate restructuring and a merger with TCR squared. And following that, we undertook a clinical pipeline review, focusing on the highest priority and value value assets.

謝謝朱莉。謝謝大家今天的加入。因此，我今天計劃回顧我們在 2023 年的進展，並分享一些關於我們 2024 年的計劃。我將主要關注 afami-cel，這將是我們肉瘤特許經營中的第一個商業產品。 2023 年是 Adaptimmune 轉型的一年。我們完成了公司重組以及與 TCR squared 的合併。隨後，我們進行了臨床管道審查，重點是最優先和最有價值的資產。

We recovered less to sell and praying from GSK. Although much of that left itself came with a fully enrolled pivotal trial has already met its primary end point for efficacy at the interim analysis, which was disclosed late last year. We also submitted the BLA for afami-cel. This is a significant milestone for Adaptimmune, obviously, but it's also a significant milestone for this sector as the first ever VLA-4 and engineered cell therapy for a solid tumor indication.

我們從葛蘭素史克那裡收回了更少的銷售和祈禱。儘管其中大部分都伴隨著一項完全入組的關鍵試驗，但在去年年底披露的中期分析中，其療效的主要終點已經達到。我們也提交了 afami-cel 的 BLA。顯然，這對 Adaptimmune 來說是一個重要的里程碑，但它也是該領域的一個重要里程碑，因為它是第一個用於實體瘤適應症的 VLA-4 和工程細胞療法。

As well as the submission we took the opportunity working with the RMAT designation to understand the FDA's requirements on a number of areas and derisk that file and also saw the FDA's agreement on the opportunity for the second cohort of that SPEARHEAD-1 trial provide the confirmatory evidence for full approval.

除了提交申請外，我們還利用與RMAT 指定合作的機會來了解FDA 在多個領域的要求並消除該申請的風險，並且還看到FDA 就SPEARHEAD-1 試驗第二組的機會達成一致，這提供了確認性的證據。完全批准的證據。

Afami-cel is the first product in our sarcoma franchise, a franchise that we estimate has peak year sales of up to $400 million. And as such, it's a beachhead for innovative cell therapy products in the solid tumor space. It's the first product of our wholly owned pipeline of cell therapy products with the most significant of those in clinical development being what a product that was previously known as ADP-A2M4CD8, but has now been granted to username of the transgene, also new cell or uza-cel.

Afami-cel 是我們肉瘤特許經營權中的第一個產品，我們估計該特許經營權的峰值年銷售額高達 4 億美元。因此，它是實體瘤領域創新細胞治療產品的灘頭堡。這是我們全資擁有的細胞治療產品系列中的第一個產品，其中臨床開發中最重要的產品是以前稱為ADP-A2M4CD8 的產品，但現在已被授予轉基因的用戶名，也可以是新細胞或烏札塞爾

The uza-cel is being developed in ovarian, bladder and head and neck cancer and all of this is enabled by our long-term investment in the capabilities needed to be a cell therapy company. That means that at this point, we have the opportunity to transition into a fully integrated commercial stage company, discovering developing and now importantly, delivering cell therapy products to patients.

uza-cel 正在針對卵巢癌、膀胱癌和頭頸癌進行開發，而這一切都得益於我們對細胞治療公司所需能力的長期投資。這意味著此時我們有機會轉型為一家完全整合的商業階段公司，發現並開發細胞治療產品，現在重要的是向患者提供細胞治療產品。

What I touch a bit on our launch preparedness has the Afami-cel is currently undergoing its priority review at the FDA. We've been informed that the FDA does not currently anticipate an outcome for Afami-cel, but we are clearly on the FDA's clock now. That everything is proceeding as you would anticipate for a product with priority review and a PDUFA date in August. If Afami-cel is a highly anticipated product and we intend to be in the position to commercialize it Afami-cel on approval in August.

關於我們的上市準備工作，我想說的是 Afami-cel 目前正在 FDA 接受優先審查。我們獲悉 FDA 目前並未預期 Afami-cel 的結果，但我們現在顯然已經在 FDA 的時間上了。一切都按照您對優先審查產品的預期進行，PDUFA 日期為 8 月。如果 Afami-cel 是一款備受期待的產品，並且我們打算在 8 月獲得批准後將其商業化。

To that end, I'm delighted to welcome back since you put Cintia Piccina as our Chief Commercial Officer to lead our commercial efforts for Afami-cel in due course for letter. So and the rest of the pipeline that I talked about, we are in the final stages of recruiting the commercial team with the majority of that headcount secured and the remaining few roles will be in place by the middle of the second quarter. Same goes for the medical affairs team with the majority of that team recruited and the remaining members of that team join us over the next few weeks.

為此，我很高興地歡迎您回來，因為您任命 Cintia Piccina 為我們的首席商務官，負責領導我們在 Afami-cel 的商業工作。因此，以及我談到的其餘管道，我們正處於招募商業團隊的最後階段，其中大部分人員已確定，其餘的少數職位將在第二季中期就位。醫療事務團隊也是如此，團隊的大部分成員已被招募，團隊的其餘成員將在接下來的幾週內加入我們。

We've also bolstered the manufacturing team, and we'll be scaling that up to meet the commercial demand for Afami-cel. I want to put a remind everybody that we have manufacture of Afami-cel in house at the Navy Yard facility in Philadelphia. We believe this is a key differentiator giving us not only control and the ability to scale demand according to our needs, but also the opportunity to produce Afami-cel at a margin that will be very attractive. And we've referred previously to a 70% margin for our sarcoma franchise of peak-year sales.

我們也增強了製造團隊，並將擴大規模以滿足 Afami-cel 的商業需求。我想提醒大家，我們在費城海軍造船廠工廠內生產 Afami-cel。我們相信，這是一個關鍵的差異化因素，不僅使我們能夠控制和根據我們的需求擴展需求的能力，而且還使我們有機會以非常有吸引力的利潤生產 Afami-cel。我們之前提到過我們的肉瘤專營權的高峰年銷售利潤率為 70%。

As you see from this slide, we have a clear plan to stand up the necessary infrastructure, and we are on track to do so for that launch, including a sponsored testing plan for the MAGE-A4 diagnostic and the patient support infrastructure necessary to help patients and their and providers navigate through treating patients with Afami-cel. Subject to FDA's approval around the PDUFA date. We anticipate actually infusing up those patients with Afami-cel in Q4 2024.

正如您從這張幻燈片中看到的，我們有一個明確的計劃來建立必要的基礎設施，並且我們正在為該發布做好準備，包括MAGE-A4 診斷的讚助測試計劃以及幫助患者提供必要的支持基礎設施患者及其服務提供者透過 Afami-cel 治療患者進行導航。須在 PDUFA 日期前後獲得 FDA 的批准。我們預計在 2024 年第四季實際為這些患者註射 Afami-cel。

We will be updating as we go through this process to register and launch of Afami-cel. And I want to tell everybody that the first such update will occur on our Investor Day on Thursday, on April 18. There will discuss not only our plans and preparation for the commercial launch of the first engineered T-cells are solid tumor, but also the how we see the opportunity in advanced sarcomas the paucity of existing treatment options and the opportunity to hear from our patient advisory groups and providers about the opportunity represented by Afami-cel for these patients. With the Thomas LPLA filed and awaiting approval, we are executing on our plans for our sarcoma franchise.

我們將在完成註冊和啟動 Afami-cel 的過程中進行更新。我想告訴大家，第一次此類更新將於 4 月 18 日星期四的投資者日發生。會議不僅將討論我們對第一個實體瘤工程 T 細胞商業化推出的計劃和準備工作，還將討論我們如何看待晚期肉瘤中的機會、現有治療方案的缺乏以及聽取我們的患者建議的機會團體和提供者了解Afami-cel 為這些患者帶來的機會。隨著 Thomas LPLA 提交並等待批准，我們正在執行我們的肉瘤特許經營計劃。

As I referred to earlier, that T-cell has now been recovered from GSK the pivotal trial has finished enrollment. The primary endpoint for efficacy has been met and is now clear that net sellers of product in its own right and has the opportunity to go through exactly the same commercial channels that we'll be developing for Afami-cel. Resulting in substantial synergies for these overlapping patient populations. We have the opportunity to reach $400 million in peak sales with these cell therapies with an addressable patient population, a little north of 1,000 patients per year with synovial sarcoma and MRCLS.

正如我之前提到的，該 T 細胞現已從葛蘭素史克 (GSK) 回收，關鍵試驗已完成註冊。功效的主要終點已經達到，現在很明顯，產品本身的淨銷售商有機會透過與我們將為 Afami-cel 開發的完全相同的商業管道。為這些重疊的患者群體帶來巨大的協同效應。我們有機會透過這些細胞療法在可尋址的患者群體中達到 4 億美元的峰值銷售額，每年有 1,000 名滑膜肉瘤和 MRCLS 患者。

I just want to make the point that that is in the United States in the launch indications that we anticipate only. We're proud of the progress that we made in 2023. We view this as securing our place on the starting line to make cell therapy products available for people with solid tumors beginning with our sarcoma franchise. This gives us the immediate opportunity to create near term commercial value in 2024 and 2025 and set the company up for long-term success with a wholly owned pipeline of cell therapy products.

我只想指出一點，那就是在美國的發射跡像只是我們預期的。我們對 2023 年的進步感到自豪。我們認為這確保了我們在為實體瘤患者提供細胞治療產品的起跑線上的地位，從我們的肉瘤特許經營權開始。這使我們有機會在 2024 年和 2025 年創造近期商業價值，並讓公司透過全資擁有的細胞治療產品管道取得長期成功。

And with that, I'll turn over to the operator for Q&A. Operator?

然後，我將轉交給接線員進行問答。操作員？

Thank you. (Operator Instruction)

謝謝。（操作員說明）

Graig Suvannavejh of Mizuho Securities.

瑞穗證券 (Mizuho Securities) 的 Graig Suvannavejh。

New disclosure of risk of retinal vasculitis during very first injection of product.

新揭露了首次注射產品時發生視網膜血管炎的風險。

Maybe we'll come back to Graig on it.

也許我們會回到格雷格來討論這個問題。

Jonathan Chang of Leerink Partners.

Leerink Partners 的 Jonathan Chang。

Hi, guys. Good morning and thanks for taking my questions. First question, can you walk us through the assumptions around the $400 million US peak sales opportunity for the sarcoma franchise? And then second question, can you provide any additional color on the cash runway guidance by specifically on what's assumed on the payments front from current and past partners. Thank you.

嗨，大家好。早安，感謝您提出我的問題。第一個問題，您能否向我們介紹一下關於肉瘤特許經營權美國 4 億美元峰值銷售機會的假設？第二個問題，您能否特別針對目前和過去合作夥伴在付款方面的假設，對現金跑道指南提供任何額外的說明。謝謝。

Thanks, Jonathan. So I will take the question on the assumptions from the commercial perspective. And then I'll ask Gavin, our CFO, to talk about the cash runway and the cash receipts from our partners, et cetera.

謝謝，喬納森。所以我將從商業角度來回答這個假設的問題。然後我會請我們的財務長加文談談現金跑道和我們合作夥伴的現金收入等等。

So with respect to the $400 million of peak-year sales. I want to reiterate that's a US only number, and it also only speaks to the anticipated launch indications in second line advanced sarcomas, but myxoid round cell and synovial sarcoma for EBITDA. I found myself, Sunovion sarcoma for that T cell myxoid round cell and Sunovion sarcoma. Both of those indications, both of those products are characterized by HLA restriction that will HLA A2 spot, 45% of the patients.

高峰年銷售額為 4 億美元。我想重申，這只是美國的數字，它也只涉及二線晚期肉瘤的預期上市適應症，但 EBITDA 的黏液樣圓形細胞和滑膜肉瘤。我發現自己，Sunovion肉瘤為T細胞黏液樣圓形細胞和Sunovion肉瘤。這兩種適應症，這兩種產品的特徵都是 HLA 限制，會發現 45% 的患者的 HLA A2 斑點。

And they are also targeted therapies in that they have their own. Each has their own target of Afami-cel is for MAGE-A4. [Net DSL] is for NY-ESO. So the starting point is an incidence of soft tissue sarcomas of about 13,500 patients per year in the United States, you can cut that for the incidence of synovial sarcoma and myxoid round cell. Each of those represent 5% to 10% of that total. And then you cut each of those for the app HLA of 45% and the target.

它們也是標靶療法，因為它們有自己的治療方法。每個人都有自己的目標，Afami-cel是針對MAGE-A4的。 [Net DSL] 適用於 NY-ESO。因此，起點是美國每年約 13,500 名患者的軟組織肉瘤發生率，您可以將其削減為滑膜肉瘤和黏液樣圓形細胞的發生率。其中每一項都佔總數的 5% 到 10%。然後你將應用程式 HLA 和目標的每一個都削減了 45%。

And what you end up with is shown on this slide, which is about 1,000 patients a year coming through that funnel, some of which about 400 are for Afami-cel and Sunovion sarcoma. And the remainder is a little over 600 are the incremental patients for [lete-cell] in synovial sarcoma and less cell and myxoid round cell liposarcoma. So that that opportunity with both of these products adds up to a little over four, a little over 1,000 patients and $400 million of peak-year sales. Gavin, do you want to talk about the assumptions on the cash flow going forward?

這張投影片顯示了您最終得到的結果，每年約有 1,000 名患者通過該漏斗，其中約 400 名患者患有 Afami-cel 和 Sunovion 肉瘤。剩下的略多於600名是滑膜肉瘤和少細胞和黏液樣圓細胞脂肪肉瘤的[lete-cell]增量患者。因此，這兩種產品的機會總計略多於 4 個、略多於 1,000 名患者以及 4 億美元的高峰年銷售額。Gavin，您想談談對未來現金流的假設嗎？

Yes, of course at high Jonathan. So if we step through this if we take our closing liquidity of about $147 million and then over the course of our cash runway period into early January 26, we've got three sources of income that we that we have a high degree of certainty around the first of those is the smallest, which is the balance on the payment of GBP30 million from GSK. We expect to get that in Q2.

是的，當然是在高喬納森。因此，如果我們以約 1.47 億美元的期末流動性為基礎，然後在 1 月 26 日上旬的現金跑道期間，我們將獲得三個收入來源，我們對這三個收入來源具有高度的確定性第一個是最小的，是葛蘭素史克支付的3000萬英鎊的餘額。我們預計會在第二季度實現這一點。

The second component are the tax credits from the UK government, and we received in January [GBP30 million] pertaining to the claim for 2022. And we can anticipate smaller amounts as the regime changes, but we've got good line of sight to those over the next couple of years. And the third and the largest component of the payments from Genentech in association with our collaboration with them on our alginate platform are two components to that. And these are laid out in the 10-K.

第二部分是英國政府提供的稅收抵免，我們在 1 月收到了與 2022 年索賠相關的 [3000 萬英鎊]。隨著政權的變化，我們可以預期金額會減少，但我們對未來幾年的情況有很好的了解。基因泰克支付的第三筆也是最大的一筆款項與我們在海藻酸鹽平台上的合作有關，是其中的兩個組成部分。這些都在 10-K 中列出。

First, our anniversary payments totaling $150 million over the period of five years. The exact shape of that isn't public and is confidential, but we have to have those payments. And this was a key milestone R&D milestone payments of $25 million. We anticipate one of those in 2024 and one of those in 2025, it gives us line of sight to capital north of $300 million. Of course, we continue to look to the markets and continue to have easy conversations to bolster that financing.

首先，我們在五年內總共支付了 1.5 億美元的周年紀念付款。其具體形式不公開且保密，但我們必須收到這些付款。這是一個關鍵的里程碑，研發里程碑付款為 2500 萬美元。我們預計其中一項將在 2024 年實現，另一項將在 2025 年實現，這將使我們的資本規模超過 3 億美元。當然，我們將繼續關注市場並繼續進行輕鬆的對話以支持融資。

Got it. Thanks for taking my questions.

知道了。感謝您回答我的問題。

Yanan Zhu of Wells Fargo Securities.

富國銀行證券的朱亞楠。

Great. Thanks for taking our questions on the patient number. The 400 a patient for the pharmaceutical launch was wondering how many of those patients can be expected to be reached in the initial six to 10 ATCs that might be online? And also regarding the manufacturing capacity, what is the capacity that you expect to be online at the time of launch? And also a question on y ADP-A2M4CD8. Any guidance in terms of updates on data from SURPASS trials? Thank you.

偉大的。感謝您提出有關患者編號的問題。藥品上市的 400 名患者想知道，在最初的 6 到 10 個可能在線的 ATC 中，預計可以接觸到多少患者？還有關於製造能力，您預計在發佈時上線的產能是多少？還有一個關於 y ADP-A2M4CD8 的問題。有關 SURPASS 試驗資料更新的任何指導嗎？謝謝。

So I think the the exact split of those patients in those centers. Well, we're correct. The centers that we stand up first, which ones those actually are the plan is to start with six to 10, but grow fairly rapidly over the first two years of the launch to up to 30 centers. We've estimated that something a little, maybe a little north of 40% of the total patients are currently in those centers. However, we also anticipate, as with other therapies of this nature, that there will be increasing concentration of patients eligible for the therapy in the centers where we have established treatment CapEx capacity in our treatment centers over that, that we plan on that plan, we anticipate increasing over time substantially.

所以我認為這些中心的患者的確切分佈。嗯，我們是對的。我們首先建立的中心，實際上計劃一開始是 6 到 10 個，但在啟動後的頭兩年內會迅速增長到 30 個中心。我們估計，目前在這些中心的患者人數佔總患者人數的 40% 左右。然而，我們也預計，與這種性質的其他療法一樣，有資格接受該治療的患者將會越來越集中在我們已經在我們的治療中心建立了治療資本支出能力的中心，我們計劃在該計劃中，我們預計隨著時間的推移會大幅增加。

And then obviously, we'll be leveraging the existing and well established referral networks within the sarcoma community ends common centers of excellence to ensure that we make Afami-cel available to as many patients as possible. The 30 centers that that app maximum will be geographically quite well distributed across the United States, reducing the need for travel, but we fully anticipate that these patients will travel for this therapy.

顯然，我們將利用肉瘤社區內現有且完善的轉診網絡和卓越中心來確保我們為盡可能多的患者提供 Afami-cel。該應用程式最大的 30 個中心在地理上分佈在美國各地，減少了旅行的需要，但我們完全預計這些患者將前往接受這種治療。

And I want to point out in that regard as a one-off therapy, this has the opportunity of being easier for that travel to occur than if it was a constantly repeating therapy where pain proximity to home would obviously be preferable. With respect to and uza-cel as we are now calling the product previously known as ADP-A2M4 CD8 and that product will that data that we've set for that is it falls into two categories. The first is the Phase 2 trial, SURPASS 3 in platinum resistant ovarian cancer that being a registrational trial, that trial is recruiting potentially registrational trial.

我想指出的是，在這方面，作為一種一次性療法，與不斷重複的治療相比，這種治療有可能更容易發生旅行，在這種治療中，靠近家的疼痛顯然更可取。就 uza-cel 而言，我們現在將以前稱為 ADP-A2M4 CD8 的產品稱為 ADP-A2M4 CD8，該產品將根據我們設定的資料分為兩類。第一個是鉑金抗藥性卵巢癌的 2 期試驗 SURPASS 3，這是一項註冊試驗，該試驗正在招募潛在的註冊試驗。

That trial is recruiting as we speak on. And we anticipate that recruitment going through 2024 and into 2025. And we will we will be are you able to give our understanding of what happened at the interim analysis, the futility analysis as we go through those trial that trial, but we won't be putting out any efficacy data until at least at a minimum. We have enrolled and treated the last patient. With respect to the earlier studies on used to sell in head and neck cancer and in bladder cancer.

正如我們所說，該試驗正在招募。我們預計招聘工作將持續到 2024 年至 2025 年。當我們進行這些試驗時，我們將讓您能夠理解中期分析和無效性分析中發生的情況，但至少在至少之前我們不會發布任何療效數據。我們已經登記並治療了最後一位患者。關於用於治療頭頸癌和膀胱癌的早期研究。

We anticipate recruiting sufficient patients during that trial to make a decision during this year to make a decision around about the end of the year, and we will communicate the basis of that decision being data in a increased number of Phase 1 patients potentially with some of those in earlier lines and in combination with standard of care therapy. And Joanna, do you want to talk to the capacity at the Navia?

我們預計在該試驗期間招募足夠的患者，以便在今年做出決定，並在年底左右做出決定，我們將傳達該決定的基礎，即更多數量的 1 期患者的數據可能與一些那些早期的療法並與標準護理療法結合。喬安娜，你想談談 Navia 的容量嗎？

Yes. Yes. Happy to add. So So we've said that our maximum capacity for internal manufacturing in Philadelphia is around 600 to 700 patients per year. And while it will be necessary to get to that range for the launch, we will have enough capacity to meet both our anticipated clinical and commercial needs for the launch. Enabling this capacity is done through onboarding of staff, manufacturing and quality staff, and we're executing against that to make sure we we have what we need come August.

是的。是的。很高興添加。所以我們說過，我們在費城的內部生產最大能力是每年約 600 至 700 名患者。雖然發射時需要達到這個範圍，但我們將有足夠的能力來滿足我們預期的發射臨床和商業需求。這種能力的實現是透過員工、製造和品質人員的入職來實現的，我們正在為此執行，以確保我們在八月擁有所需的東西。

Great. Thanks for the color.

偉大的。謝謝你的顏色。

Graig Suvannavejh of Mizuho Securities.

瑞穗證券 (Mizuho Securities) 的 Graig Suvannavejh。

Please go ahead and good morning. So sorry about that this morning. I do have a couple of questions and congrats on the progress in the quarter. I'm curious, following the approval of [Iovance TIL basal cell therapy]. I'm wondering what you think the potential implications may be and for you guys, whether it makes things easier or any learnings out of that process that could give some incremental insight into how you think the review for your profit will be? And then also on Iovance, they were able to get an IC the 10 code as well as the GRG., I think it's 018 inclusion prior to their approval. Are you expecting [something like that for Ascensia] Thanks.

請繼續，早安。今天早上對此感到非常抱歉。我確實有幾個問題，祝賀本季的進展。我很好奇，在獲得批准後[Iovance TIL 基礎細胞療法]。我想知道您認為潛在的影響可能是什麼，對您來說，它是否會讓事情變得更容易，或者從這個過程中學到什麼可以讓您對您認為利潤審查的方式有一些漸進的了解？然後還在 Iovance 上，他們能夠獲得 IC 10 代碼以及 GRG。，我認為這是在他們批准之前包含的 018。您是否期待 [Ascensia 的類似情況] 謝謝。

Thanks for that. And so with respect to the long anticipated approval of a lot of new cell [by Iovance], where we're quite delighted about that. And we think that that that heralds the and the fact that 2024 I think really will be the year was that that cell therapy becomes a commercial reality for solid tumors as well. What will be the first to cell therapy launches with the farmers are coming in August.

感謝那。因此，對於[Iovance]期待已久的許多新細胞的批准，我們對此感到非常高興。我們認為這預示著，我認為 2024 年細胞療法也將成為實體瘤的商業現實。首次向農民推出的細胞療法將於八月推出。

Now, that having said that, I think they're very, very different commercial propositions, melanoma versus synovial sarcoma. But we look forward to Iovance doing a great job because we looked at that as indicative of how cell therapies might be adopted in the larger indications. And when you look back in our pipeline, you'll see many such larger indications where we anticipate cell therapy has the opportunity to it changed the standard of care and be transformative for patients.

話雖如此，我認為黑色素瘤與滑膜肉瘤是非常非常不同的商業主張。但我們期待 Iovance 做得很好，因為我們認為這表明了細胞療法如何在更大的適應症中採用。當您回顧我們的管道時，您會看到許多此類更大的適應症，我們預計細胞療法有機會改變護理標準並為患者帶來改變。

And so high advances experience in this large melanoma indication. I think will be really instructive. And we are we are we believe that rising tide lifts all boats in this regard for firms where we're very excited to see what their they're able to do with respect to the DRG code, I confirm you're right. We anticipate we anticipate the same code for Afami-cel.

在這種大型黑色素瘤適應症方面取得瞭如此高的進展經驗。我認為這確實很有啟發性。我們相信，水漲船高，對於公司來說，這方面的一切都將水漲船高，我們很高興看到他們能夠在 DRG 代碼方面做些什麼，我確認你是對的。我們預期 Afami-cel 的程式碼相同。

Great. And if I could ask a follow-up, just on the prime opportunity. Obviously, a lot of interest in that target and how are you guys assessing the competitive landscape and freight rates?

偉大的。如果我可以詢問後續情況，就在這個絕佳的機會上。顯然，人們對這個目標很感興趣，你們如何評估競爭格局和運費？

So I'm going to ask Joe, our Chief Scientific Officer to take stab at that and talk about that and the our differentiation of our Prime program. Joe?

因此，我將請我們的首席科學官 Joe 對此進行探討，並討論這一點以及我們 Prime 計劃的差異化。喬？

Thanks, Adrian. Yes, we're very excited about prime as a target as the field in general is I think there's obviously we're well aware that there's lots of competition in this area from bispecifics as well as cell therapies. But we're still quite bullish about our own internal program because we have a strong TCR that was previously partnered with GSK, and we're looking at ways of taking that forward. So in our own internal analysis, where we've and looked at other competitor products, we think our TCR does have a different safety profile, which we are very happy with.

謝謝，阿德里安。是的，我們對 Prime 作為目標感到非常興奮，因為我認為整個領域顯然我們很清楚，該領域存在著來自雙特異性藥物和細胞療法的大量競爭。但我們仍然非常看好我們自己的內部計劃，因為我們擁有強大的 TCR，之前曾與 GSK 合作，我們正在尋找推進這項計劃的方法。因此，在我們自己的內部分析中，我們研究了其他競爭對手的產品，我們認為我們的 TCR 確實具有不同的安全性，對此我們感到非常滿意。

And we're also looking at ways of bringing next generation additions to prime to actually make it competitive that we want to look at our TCR for frame in multiple different constructs, say that we can choose the best one in the clinic and take that forward. So we will be we start with the TCR, which we believe has a good safety profile, and we're looking at ways of improving the efficiency for next gen up to a next-gen opportunities and premise, a really complementary target to our other programs base in ovarian with Intercell and other indications. So we're hoping to leverage our clinical experience in those indications to really push them forward.

我們也正在尋找將下一代附加功能引入 Prime 的方法，以真正使其具有競爭力，我們希望在多種不同結構中查看我們的 TCR 框架，說我們可以選擇臨床中最好的一個並繼續前進。因此，我們將從 TCR 開始，我們相信它具有良好的安全性，我們正在尋找提高下一代效率的方法，以達到下一代機會和前提，這是我們其他目標的真正補充目標計劃以卵巢為基礎，具有Intercell 和其他適應症。因此，我們希望利用我們在這些適應症方面的臨床經驗來真正推動它們向前發展。

Thank you for taking my questions.

感謝您回答我的問題。

Thanks Greg.

謝謝格雷格。

Peter Lawson of Barclays.

巴克萊銀行的彼得·勞森。

Commodities are shaping on for Peter Lawson. Thank you for taking our question. But just to touch a little bit more on the Omnicell launch in 3Q, and I believe you've highlighted that you'll be focusing on six to 10 treatment centers and indicating. Could you maybe add a little color for how you're expecting to scale up to the 30 additional treatment centers and how long that might take and if you're expecting any kind of bolus of onboarding of patients in 3Q? Thank you so much.

彼得勞森 (Peter Lawson) 的大宗商品狀況正在好轉。感謝您提出我們的問題。但我想稍微多談談第三季推出的 Omnicell，我相信您已經強調了您將專注於 6 到 10 個治療中心並表示。您能否補充一下您預計如何擴大到另外 30 個治療中心，可能需要多長時間，以及您是否預計在第三季度增加患者入職？太感謝了。

Thanks. And so yes, we anticipate that the first wave of treatment centers will be up and running within that launch windows six to 10 within that launch window and then expanding quite rapidly. We anticipate that we will be at up to 30 centers within the first two years of following launch, on those treatment centers. The initial ones are almost exclusively on major sarcoma that what they are all major sarcoma centers.

謝謝。所以，是的，我們預計第一波治療中心將在啟動視窗內的 6 到 10 個啟動視窗內啟動並運行，然後迅速擴張。我們預計在推出後的頭兩年內，我們將在多達 30 個治療中心開展業務。最初的幾乎完全是在主要肉瘤上，它們都是主要肉瘤中心。

They are obviously, therefore a major treatment centers and they have deep experience of cell therapy. They almost also have a lot of experience of working with afami-cel. And as we roll out to the top30 centers since we have been conducting our clinical trials and GSK was conducting the clinical trial for let us sell in major sarcoma centers.

因此，他們顯然是主要的治療中心，並且在細胞治療方面擁有豐富的經驗。他們幾乎也有很多與 afami-cel 合作的經驗。當我們向前 30 家中心推出時，我們一直在進行臨床試驗，葛蘭素史克正在進行臨床試驗，讓我們在主要肉瘤中心進行銷售。

There's obviously going to be a large overlap between the clinical trial footprint for those two products. And these are the centers that has the advantage that the physicians know and understand afami-cel well, having used utilized it in clinical trials that they're well used to cell therapy and they are in the major treatment centers, the top tier of the sarcoma centers of excellence. But I'll answer the questions, I think any further questions.

顯然，這兩種產品的臨床試驗足跡之間會有很大的重疊。這些中心的優勢在於，醫生非常了解和了解 afami-cel，並在臨床試驗中使用過它，他們非常習慣於細胞治療，而且他們位於主要的治療中心，是頂級的治療中心。肉瘤卓越中心。但我會回答這些問題，我想還有其他問題。

This concludes the question and answer session. I would like to turn the conference back over to Adrian cliff for any closing remarks.

問答環節到此結束。我想將會議轉回阿德里安·克利夫進行閉幕致詞。

Thank you, and thanks, everybody, for being on the call and thanks for your questions. Are we're excited to have come this far in 2023. We look forward in 2024 to our first commercial approval and launch, and we'll be updating you as we go through the year starting, I think with our Investor Day on April 18, at our Navy Yard facility in Philadelphia, and we look forward to seeing as many of you there as possible. Take-care.

謝謝大家，謝謝大家的來電，也謝謝你們提出的問題。我們很高興能在 2023 年走到這一步嗎？我們期待在 2024 年獲得首次商業批准和啟動，並且我們將從 4 月 18 日在費城海軍造船廠舉行的投資者日開始向您通報最新情況，我們期待盡可能多地見到你們。小心。

This concludes today's conference call. You may disconnect your lines. Thank you for participating and pleasant day.

今天的電話會議到此結束。您可以斷開線路。感謝您的參與和愉快的一天。