Adaptimmune Therapeutics PLC (ADAP) 2024 Q4 法說會逐字稿

Hello and welcome to the Adaptimmune Q4 and full year 2024 business update conference call. (Operator Instructions)

您好，歡迎參加 Adaptimmune 第四季和 2024 年全年業務更新電話會議。（操作員指示）

I wound now like to turn the floor over to Juli Miller. Investor Relations for Adaptimmune. Juli, please go ahead.

現在我想把發言權交給朱莉·米勒。Adaptimmune 的投資人關係。朱莉，請繼續。

Good morning and welcome to Adaptimmune's conference call to discuss our full year in fourth quarter 2024 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 leadership team will be available for Q&A.

早安，歡迎參加 Adaptimmune 電話會議，討論我們 2024 年第四季全年業務更新。我希望您能閱讀今天早上新聞稿中的前瞻性聲明全文。我們預計將在本次電話會議中做出預測，但實際結果可能會因多種因素而存在重大差異，包括我們向美國證券交易委員會提交的最新文件中概述的因素。我們的執行長 Adrian Rawcliffe；在我參加電話會議的準備部分時，我們領導團隊的其他成員也將參加問答環節。

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

說完這些，我會把電話轉給 Adrian Rawcliffe。阿德里安？

Thanks, Juli, and thank you everybody for joining us on today's call. I'd like to begin by discussing the [Tecelra] launch and the fantastic momentum that we've seen building since our approval late last year. This launch, as has been our top priority, and we have provided some updated performance metrics in this morning's press release.

謝謝，朱莉，也謝謝大家參加今天的電話會議。首先，我想討論一下 [Tecelra] 的推出以及自去年年底獲得批准以來我們所看到的強勁發展勢頭。此次發布一直是我們的首要任務，我們在今天早上的新聞稿中提供了一些更新的效能指標。

But I'm going to go into more details on this call so that you can see why we're so excited that our long-range forecast of at least $400 million in combined Synovial sarcoma sales seems very achievable given these early success indicators. Currently, we have 20 authorized treatment centers or ATCs available through our network, which you can find on [tcellular.com] and that's pretty much updated in real time for the most part.

但我將在這次電話會議上進行更詳細的介紹，以便您了解我們為何如此興奮，鑑於這些早期的成功指標，我們對滑膜肉瘤總銷售額至少 4 億美元的長期預測似乎非常可行。目前，我們的網路內有 20 個授權治療中心或 ATC，您可以在 [tcellular.com] 上找到這些中心，這些資訊大部分都是即時更新的。

These 20 ATCs represent a full 2/3 of our planned treatment network of approximately 30 sites. So we are very much ahead of schedule in setting up these ATCs. When we launched last year, we intended to have the full network established by late 2026, and our Q3 earnings in November, and based on enthusiasm from sites and the progress that we're seeing up to that point, we accelerated that timeline to the end of this year.

這 20 個 ATC 占我們計劃的約 30 個站點的治療網絡的 2/3。因此，我們在設立這些 ATC 方面已經遠遠提前了計劃。去年我們推出時，計劃在 2026 年底之前建立完整的網絡，並在 11 月實現第三季度盈利，並且基於網站的熱情以及我們迄今為止看到的進展，我們將該時間表加速到今年年底。

Now, having 2/3 of these sites up and running already, we are very much on track to have the full network by the end of the year. Now [once] patients being treated with [T sarcoma]. In Q4 last year, we Apheresed three patients and two of those were invoiced, resulting in Q4 recorded product revenue of $1.2 million. In Q1 2025, as of today, we have apheresed 10 more patients, and we have three additional apheresed scheduled by the end of March for an anticipated total of 13 patients Apheresed in Q1 2025.

現在，這些站點中的 2/3 已經啟動並運行，我們預計在今年年底前建造完整的網路。現在[曾經]接受治療的患者[T肉瘤]。去年第四季度，我們為三名患者進行了血液透析，其中兩名患者開出了發票，導致第四季度的產品收入達到 120 萬美元。在 2025 年第一季度，截至今天，我們已為另外 10 名患者進行了血液檢查，並且我們計劃在 3 月底之前再為另外 3 名患者進行血液檢查，預計 2025 年第一季度將為 13 名患者進行血液檢查。

This means we're likely to a apheresed more than four times as many patients in Q1 as we did in the prior quarter. Furthermore, we anticipate that the majority of the 10 patients apheresed in Q1 to date will be invoiced in Q1, with the remainder in Q2. As such, we anticipate invoicing three to four times as many patients in Q1, i.e., approximately six to eight patients as we did in the prior quarter. And we can see this launch is accelerating rapidly and our KPIs are in line with or indeed exceeding our projections, which is a testament to the team's hard work and to the unmet need of sarcoma patients and the recognition from their treating physicians that T-cell offers a real solution.

這意味著我們第一季的患者數量可能比上一季多四倍。此外，我們預計，迄今為止在第一季接受血液檢查的 10 名患者中的大多數將在第一季開立發票，其餘患者將在第二季度開立發票。因此，我們預計第一季的患者數量將是上一季的三到四倍，大約六到八名患者。我們可以看到，此次發布正在迅速加速，我們的 KPI 符合甚至超過了我們的預期，這證明了團隊的辛勤工作和肉瘤患者未滿足的需求以及他們的主治醫生對 T 細胞提供真正解決方案的認可。

And we anticipate the acceleration of these numbers will continue. We have an additional pool of around 20 patients who are biomarker positive. And we expect the majority of these patients to be treated in Q2 and Q3 this year. And behind that, we estimate that approximately 30 patients are in various stages of testing. Now, we don't have full visibility into all of the MAGE-A4 testing that occurs, but more than 80 patients have completed testing for MAGE-A4 using our sponsored testing program since launch, with a positivity rate, which is as expected, around 65%.

我們預計這些數字的成長速度還將持續。我們還有另外約 20 名生物標記呈陽性的患者。我們預計這些患者中的大多數將在今年第二季和第三季接受治療。除此之外，我們估計大約有 30 名患者正處於不同階段的檢測中。現在，我們還沒有完全了解所有發生的 MAGE-A4 測試，但自推出以來，已有超過 80 名患者使用我們贊助的測試計劃完成了 MAGE-A4 測試，陽性率如預期的那樣，約為 65%。

On the payer front, we've had tremendous success with reimbursement. Over 70% of commercial and Medicare lives are in plans that already have established policies in place to cover Tecelra. To date, we haven't experienced a single denial, which is a great accomplishment for the team and even greater outcome for patients, obviously. Before we move off launch performance, I'd be remiss not to discuss manufacturing, since this is so important for cell therapies.

在付款人方面，我們在報銷方面取得了巨大的成功。超過 70% 的商業和醫療保險計劃都已製定了涵蓋 Tecelra 的保單。到目前為止，我們還沒有遇到過一次拒絕的情況，這對團隊來說是一個巨大的成就，對患者來說顯然是一個更大的結果。在我們開始討論發表會表現之前，如果不討論一下製造過程，那我就太失職了，因為這對細胞療法來說非常重要。

As an effective, efficient delivery of autologous cell therapies is, in our view, a critical, indeed a defining characteristic for successful commercialization campaigns. The manufacturing has exceeded all of our goals and expectations. Although the numbers so far are small, 100% of the released products were manufactured to specification, with no manufacturing failures. Our average turnaround time from apheresis to product release has been less than our target of 30 days.

我們認為，作為一種有效、高效的自體細胞療法，是成功商業化活動的關鍵特徵，甚至是決定性特徵。製造過程超越了我們所有的目標和期望。儘管目前數量很少，但 100% 發布的商品均符合規格製造，沒有任何製造故障。我們從血液分離到產品發布的平均週轉時間少於我們設定的 30 天的目標。

We've had no capacity bottlenecks so far, and we have a robust supply of all the key materials, including, importantly, vector already in place. We should have no trouble meeting the anticipated accelerating demand in the coming quarters that I referenced earlier. The net result of everything we're seeing across our treatment network, our commercial and manufacturing teams, is that we anticipate sales of T-cell oil will continue to accelerate in each quarter this year as the pipeline of new patients flows through, as new ATCs come online.

到目前為止，我們沒有遇到產能瓶頸，我們擁有所有關鍵材料的充足供應，其中重要的是已經到位的載體。我們應該能夠毫無困難地滿足我之前提到的未來幾季預計將加速成長的需求。從我們的治療網絡、商業和製造團隊所看到的一切來看，我們預計，隨著新患者的湧入和新 ATC 的上線，T 細胞油的銷售將在今年每個季度繼續加速成長。

And as the timelines for each patient moving through the process becomes more efficient and more streamlined. As of now, we have good visibility of the patients we expect for delivery in April. And although we're not yet in a position to provide formal revenue guidance, we feel very confident that the current consensus analyst forecast of approximately $25 million of sales in 2025 is very achievable. This is a testament to the commercial and CMC capabilities we've thoughtfully and strategically built and which are now firing on all cylinders.

隨著每位患者接受治療的時間變得更有效率和簡化。截至目前，我們對四月預計分娩的患者情況已經有了清晰的了解。儘管我們尚未能夠提供正式的收入指導，但我們非常有信心，目前分析師對 2025 年約 2500 萬美元銷售額的預測是可以實現的。這證明了我們經過深思熟慮和策略性構建的商業和 CMC 能力，目前正全力以赴。

Most importantly though, it's a testament to the strength of the clinical data, as reflected in the approved label, which has provided patients and their treating oncologists with the confidence that Tecelra is the right choice. Now we've built this commercial infrastructure, not only for Tecelra, the first product in the sarcoma franchise, but also for the next product, Lete-cel, which we expect to be on the market in 2027. The data we've generated for Lete-cel is as strong as that for Tecelra and will be the basis for the BLA filing, which is on track for submission later this year.

但最重要的是，它證明了臨床數據的強度，正如批准的標籤所反映的那樣，它為患者及其治療腫瘤學家提供了信心，並相信 Tecelra 是正確的選擇。現在，我們已經建立了這個商業基礎設施，不僅針對肉瘤系列中的第一款產品 Tecelra，也針對下一款產品 Lete-cel，我們預計該產品將於 2027 年上市。我們為 Lete-cel 產生的數據與 Tecelra 的數據一樣強大，並將成為 BLA 申請的基礎，該申請將於今年稍後提交。

Tecelra and Lete-cel form the basis of our Sarcoma franchise, and as stated previously, we expect to see US peak sales of approximately $400 million. Since Lete-cel will use the same commercial footprint as Tecelra, we will achieve significant operational channel and cost synergies. Put another way, the incremental cost to launch Lete-cel is minor, given that most of the capabilities will already be in place by the time of launch in 2027.

Tecelra 和 Lete-cel 構成了我們肉瘤特許經營的基礎，如前所述，我們預計美國的銷售額高峰將達到約 4 億美元。由於 Lete-cel 將使用與 Tecelra 相同的商業足跡，我們將實現顯著的營運管道和成本協同效應。換句話說，考慮到 2027 年發射時大部分功能已經到位，發射 Lete-cel 的增量成本很小。

Now I'm going to elaborate a little more on Lete-cel, and in particular on the IGNYTE-ESO pivotal data that met its primary endpoint and was presented at CTOS last year. Efficacy is similar to what we saw with the Fama cell, which was the basis for approval of Tecelra, and in the 64 patients treated with Lete-cel in the [IGNYTE] trials, there is a 42% overall response rate. This also included six complete responses, and that's a complete response rate of almost 10% in these advanced metastatic Synovial sarcoma and myxoid liposarcoma patients.

現在我將更詳細地介紹 Lete-cel，特別是達到其主要終點並在去年 CTOS 上展示的 IGNYTE-ESO 關鍵數據。其療效與我們在 Fama 細胞中看到的療效相似，這也是 Tecelra 核准的基礎，在 [IGNYTE] 試驗中接受 Lete-cel 治療的 64 名患者中，整體反應率為 42%。其中還包括 6 例完全緩解，對於這些晚期轉移性滑膜肉瘤和黏液樣脂肪肉瘤患者來說，完全緩解率接近 10%。

For these patients with a few other options, this is a transformational advance. As I mentioned, these data will serve as the basis for the rolling BLA filing plan to begin later this year. And I also want to point you to a [KOL] event we previously hosted, which we've linked in our PR this morning. That Dr. Sandra D'Angelo from Memorial Sloan Kettering Cancer Center led after CTOS. Dr. Sandra D'Angelo, who has been the lead investigator in our trials, framed Lete-cel from the perspective of the provider.

對於那些擁有其他選擇的患者來說，這是一個變革性的進步。正如我所提到的，這些數據將作為今年稍後開始的滾動 BLA 備案計劃的基礎。我還想向您介紹我們之前舉辦的一個 [KOL] 活動，我們今天早上在 PR 中已經連結了該活動。由紀念斯隆凱特琳癌症中心的 Sandra D'Angelo 博士領導的 CTOS 後續工作。我們試驗的首席研究員桑德拉·德安傑洛博士從提供者的角度構建了 Lete-cel。

She was enthusiastic not only about the data but also about having another future treatment option. She speaks compellingly about her patients who often in the prime of their lives receive a devastating diagnosis of synovial sarcoma or myxoid liposarcoma and have limited treatment options. Doctor D'Angelo highlighted Lete-cel's significant improvement over standard of care and described the treatment journey from screening to dosing as streamlined.

她不僅對數據充滿熱情，而且對未來的另一種治療選擇也充滿熱情。她令人信服地講述了她的病人的故事，這些病人往往在人生的黃金時期被診斷出患有滑膜肉瘤或黏液樣脂肪肉瘤，並且治療選擇有限。D'Angelo 醫生強調了 Lete-cel 在護理標準方面的顯著改善，並將從篩檢到給藥的治療過程描述為簡化的。

If you want to understand the transformative nature of these therapies in this space, I encourage you to listen to her presentation, which is on our website. Lete-cel will expand our comma franchise into NY-ESO expressing synovial sarcoma and myxoid liposarcoma, which we anticipate will more than double the number of treatable patients in the US each year. We estimate that Lete-cel will eventually make up over 60% of our combined sarcoma franchise revenue.

如果您想了解這些療法在該領域的變革性質，我鼓勵您聽聽她在我們網站上的演講。Lete-cel 將把我們的逗號特許經營權擴展到 NY-ESO 表達滑膜肉瘤和黏液樣脂肪肉瘤，我們預計這將使美國每年可治療患者的數量增加一倍以上。我們估計 Lete-cel 最終將占我們肉瘤特許經營總收入的 60% 以上。

Switching gears a little. Last quarter, we shared the key priorities for our restructuring and for the company going forward. These were one, to build a successful business with what we anticipate will be two FDA approved products in sarcoma. Two, to substantially reduce the need to bring in additional capital before becoming cash flow positive. And three, to achieve our objective to be cash flow break even in 2027.

稍微轉換一下話題。上個季度，我們分享了重組和公司未來發展的重點。我們的目標是透過預計將獲得 FDA 批准的兩種治療肉瘤的產品來打造成功的業務。二是大幅減少現金流轉為正值之前引進額外資本的需要。第三，實現我們的目標，在 2027 年達到現金流收支平衡。

The update on the launch of Tecelra and the progress with Lete-cel demonstrates we are well on track to meet the first of these objectives, building our sarcoma business. On the capital reductions and the cash flow break even in the 2027 objectives, we have two updates for you today. First, we're pausing spending on our pre-clinical programs targeting PRAME and CD70. This decision reduces our forward cash flow demands in the period through 2028 by approximately $75 million to $100 million.

Tecelra 的上市更新以及 Lete-cel 的進展表明，我們正順利實現第一個目標，即建立我們的肉瘤業務。關於2027年目標中的資本削減和現金流損益平衡，我們今天為您提供兩項更新。首先，我們暫停針對 PRAME 和 CD70 的臨床前項目的支出。這項決定將使我們在 2028 年期間的遠期現金流需求減少約 7,500 萬美元至 1 億美元。

This is in addition to the $300 million of full cash savings over this period we announced at the end of last year as a result of our restructuring. Secondly, we've engaged TD Cowan to help us explore all strategic options and evaluate every financial opportunity to ensure we achieve our goals and optimize value for our shareholders. This includes potential partnerships or collaborations, strategic combinations, various financial transactions, and multiple pipeline monetization opportunities.

這是我們在去年年底宣布的透過重組在此期間節省 3 億美元現金的額外舉措。其次，我們聘請了 TD Cowan 來幫助我們探索所有策略選擇並評估每一個財務機會，以確保我們實現目標並為股東實現價值最大化。這包括潛在的合作夥伴關係或合作、策略組合、各種金融交易以及多種管道貨幣化機會。

We won't say much more beyond this, and while we appreciate all your questions, we will only provide an update on the progress of these initiatives when we have something meaningful to discuss. We have a lot of options and financial levers we can pull while we continue to execute our commercial strategy from a position of strength with the early success of the Tecelra launch.

除此之外我們不會透露太多，雖然我們感謝你們提出的所有問題，但只有當我們有有意義的事情要討論時，我們才會提供這些舉措的進展更新。我們擁有許多選擇和財務槓桿可以利用，同時憑藉 Tecelra 早期的成功推出，我們將繼續以優勢地位執行我們的商業策略。

In summary, we have great traction and acceleration on the launch of launch, and we'll continue to provide updates on this and the progress of Lete-cel towards a rolling BLA submission later this year. We will continue to effectively manage our costs as we push towards profitability in 2027. And in the context of the current capital markets, we will leave no stone unturned to enable us to achieve our objectives.

總而言之，我們在發布會上取得了巨大的進展和加速，我們將繼續提供有關此事的最新消息以及 Lete-cel 在今年稍後提交滾動 BLA 的進展。我們將繼續有效管理成本，並努力在 2027 年實現盈利。在當前資本市場的背景下，我們將竭盡全力實現我們的目標。

And with that, I'll open the call up for questions. Operator.

現在，我將開始回答問題。操作員。

(Operator Instructions) Marc Frahm, TD Cowen.

（操作員指示）Marc Frahm，TD Cowen。

Hi, this is Alex. I'm from Mark. Thanks so much for taking my question. Just a couple on the Tecelra launch. So first, could you comment on the pace of aphesis during Q1, specifically where patient numbers higher in March versus January? And then, given the cost savings you're working on, how many patients per year do you think you'll need to treat in order to achieve profitability in 2027? Thanks.

你好，我是亞歷克斯。我來自馬克。非常感謝您回答我的問題。Tecelra 發表會上只有幾位嘉賓。那麼首先，您能否評論一下第一季的治療速度，特別是 3 月的患者人數是否高於 1 月？然後，考慮到您正在努力節省的成本，您認為每年需要治療多少名患者才能在 2027 年獲利？謝謝。

So I'm going to ask Cintia, to comment on the pace of a [ATC] as we've gone through the last part of last year and into this year. And, then I'll, take the second question on profitability for the company as a whole.

因此，我要請 Cintia 評論一下 [ATC] 的步伐，因為我們已經度過了去年最後階段並進入了今年。然後，我將回答整個公司獲利能力的第二個問題。

Thank you, Adrian. Thank you so much. So the pace of phrases has been increasing, as you would imagine, we started to open our ATC network last year. So the majority of the apheresed came. From the first ATCs that were open, we see that the a came from five different ATCs. And as we continue to onboard treatment centers, the pace has been increasing over time. So we certainly had a greater number of apheresis' in February and March than we had in the prior months. So the pace has been really very exciting.

謝謝你，艾德里安。太感謝了。因此，短語的速度一直在加快，正如您所想像的，我們去年開始開放我們的 ATC 網路。因此，大多數已採血者都來了。從第一個開放的 ATC 來看，我們看到 a 來自五個不同的 ATC。隨著我們繼續加入治療中心，步伐也隨之加快。因此，我們二月和三月的血液分離數量肯定比前幾個月要多。所以節奏確實非常令人興奮。

And on the second, question, we deliberately and specifically haven't provided for revenue guidance, through any of the mechanisms, that, your questions imply. So I'm not going to actually give you forward guidance in 2027 at that point, but other than to say that the, by that point, of course, Tecelra. It is sort of in its essentially in its second full year, after launch, its third year after approval. And, obviously Lete-cel will have launched by that point in time, and it's the combination of those two together that, get us to, operating profitability.

關於第二個問題，我們故意且明確地沒有透過任何機制提供收入指導，正如您的問題所暗示的那樣。因此，到那時我實際上不會給你 2027 年的前瞻性指引，但除此之外，當然可以這麼說，到那時，Tecelra 將會實現。從推出到現在，它基本上已經進入了第二個完整年頭，也就是獲得批准後的第三年。顯然，Lete-cel 將在那個時候推出，而這兩者相結合，將使我們實現營運盈利。

Great, thank you.

太好了，謝謝。

Yes Alex.

是的，亞歷克斯。

Paul Jeng, Guggenheim.

古根漢美術館的保羅鄭（Paul Jeng）。

Hi, this is Paul. I'm for Michael. Thanks for taking our questions. So just on the launch as well, last quarter, I believe you mentioned there had been 15 confirmed double positive patients as of November. Can you just confirm what proportion of those patients are the ones who went on to undergo apheresed this year. And for those who did not, are they still candidates for treatment down the line or if they've dropped out of the treatment journey, do you have any visibility into why?

你好，我是保羅。我支持麥可。感謝您回答我們的問題。因此，就在上個季度的發布會上，我相信您提到過，截至 11 月，已有 15 名確診的雙重陽性患者。您能否確認這些患者中有多少比例是今年接受血液透析治療的患者？對於那些沒有接受治療的患者，他們是否仍適合繼續接受治療？或者，如果他們已經退出治療，您是否知道原因？

Cintia?

辛西亞？

Yes. So we, the majority of the patients that were double positive have already been starting the journey, and the 10 patients that we apheresed so far are part of those. The majority of the others are still in the journey at different stages. We would expect some dropouts, not all of the patients are going to eventually be treated. We haven't seen a lot of them to date, but there could be different reasons why patients could potentially drop out. But what we've been seeing is that the majority of them went through an apheresis or are still waiting to be treated.

是的。因此，我們大多數雙重陽性患者都已經開始了治療，到目前為止，我們接受血液檢查的 10 名患者就是其中的一部分。其餘大多數人仍處於不同階段的旅程中。我們預期會有一些人退出治療，並不是所有患者最終都會得到治療。到目前為止，我們還沒有看到很多這樣的情況，但患者退出治療可能有不同的原因。但我們看到的情況是，他們中的大多數人已經接受了血液分離術或仍在等待治療。

Okay. And then perhaps just to follow up, do you have any visibility into what line of therapy that the patients typically are on who are going into testing? In other words, what proportion of patients who are getting tested could immediately move into treatment if qualified as double positive versus those that are prepped earlier and being tested in frontline and still being treated with other therapies? Thank you.

好的。然後也許只是為了跟進，您是否了解接受檢測的患者通常接受哪種療法？換句話說，如果被判定為雙重陽性，接受檢測的患者中有多少比例可以立即接受治療，而那些之前已經做好準備並在一線接受檢測並仍在接受其他療法治療的患者中有多少比例可以立即接受治療？謝謝。

The majority of the patients, the large majority of the patients are patients that are being tested with the intent to be treated with Tecelra. So they have already been exposed to chemotherapies, they could be at different stages of their journey over time we do expect to see testing happening earlier in the treatment journey. And it's something that we'll hopefully be able to support as we grow into the awareness of biomarkers, but today, the majority of the patients tested are patients that are eligible to start being treated with the right way.

大多數患者，絕大多數患者都是接受 Tecelra 治療測試的患者。因此，他們已經接受過化療，隨著時間的推移，他們可能處於治療過程的不同階段，我們確實希望在治療過程的早期進行測試。隨著我們對生物標記的認識不斷提高，我們希望能夠支持這一點，但今天，接受檢測的大多數患者都是有資格開始接受正確治療的患者。

Okay, thank you.

好的，謝謝。

Jonathan Chang, Leerink Partners.

Jonathan Chang，Leerink Partners。

Hi guys, good morning. Thanks for taking my questions. First, on the path to profitability in 2027, can you remind us what the assumptions are and other considerations that feed into that goal?

大家好，早安。感謝您回答我的問題。首先，在 2027 年實現盈利的道路上，您能否提醒我們實現這一目標的假設是什麼以及其他考慮因素？

Certainly. So when we were previously, -- when we previously announced the restructuring, we talked about the pattern of our spending in 2025, 2026, and 2027. You might recall that we said that we would reduce our spending by about $50 million anticipated in 2025 from the levels in 2024. And then by $70 million to $80 million each of 2026 and 2027. And that implies a cost base coming down from a little north of $200 million to sort of $130 million $140 million.

當然。因此，當我們之前宣布重組時，我們談到了 2025 年、2026 年和 2027 年的支出模式。您可能還記得，我們​​曾說過，預計 2025 年的支出將在 2024 年的基礎上減少約 5,000 萬美元。然後在 2026 年和 2027 年分別增加 7,000 萬至 8,000 萬美元。這意味著成本基礎將從略高於 2 億美元降至 1.3 億美元至 1.4 億美元左右。

We've now subsequently announced that we are pausing the investment in [premium] and 520. And whilst we haven't calendarized that has a significant incremental impact in the future years on that, reducing that still further. Against that backdrop, we have the approval and launch of, the approval and launch of, two products at Tecelra, obviously last year and the sales of that, which we're now really starting to see, ramp up and offset that.

我們隨後宣布暫停對 [premium] 和 520 的投資。雖然我們還沒有將其日曆化，但在未來幾年中，這會產生顯著的增量影響，並進一步減少這種影響。在此背景下，我們在去年批准並推出了 Tecelra 的兩款產品，現在我們真正開始看到這兩款產品的銷量上升並抵消了這一影響。

And then, in, we anticipate the, approval of Lete-cel, on the basis of the BLA which we'll complete in the second quarter of next year, and which we anticipate the first sales in 2027 on approval in late 2026. So first recognized sales in 2027, and it's the combination of those two ramping up, and we've not provided specific annual sales guidance for either product or in total, but we have said that we anticipate US sales of $400 million in total at peak for our sarcoma franchise. Hopefully, that's helpful.

然後，我們預計 Lete-cel 將獲得批准，基於我們將在明年第二季完成的 BLA，我們預計在 2026 年底獲得批准後，將於 2027 年實現首次銷售。因此，首先確認的銷售額是在 2027 年，這是兩者結合的成長，我們還沒有為任何一款產品或總銷售額提供具體的年度銷售指導，但我們說過，我們預計我們的肉瘤特許經營權在美國的銷售額高峰期將達到 4 億美元。希望這會有所幫助。

Understood. So I guess just synthesizing all of that together, did do you believe you have sufficient cash, today, to get to your goal of being profitable in in 2027? Or does it assume?

明白了。所以我想，綜合所有這些因素，您是否認為您今天擁有足夠的現金來實現 2027 年盈利的目標？或者它假設？

No, let's we said that last year, that remains the case now, and the opportunities that we are exploring with the help of TD Cowan, to enable us to bridge to that profitability, to ensure that we are able to appropriately finance the company, over this time period to get to that goal of profitability in 2027.

不，我們去年就說過了，現在情況仍然如此，我們正在 TD Cowan 的幫助下探索各種機會，使我們能夠實現盈利，確保我們能夠在這段時間內為公司提供適當的融資，以實現 2027 年盈利的目標。

Understood maybe just one last question for me then how are you guys thinking about potential business development opportunities for the company, for your programs, platform, et cetera.

我明白，也許這只是我的最後一個問題，那麼你們如何看待公司、專案、平台等潛在的業務發展機會。

So we have, -- as we have a pipeline of opportunities praying, the CD 70 program. We have an ongoing collaboration and partnership with our partner Galapagos, on user cell, and then we have the non-US territories for our sarcoma franchise, all of those are available for partnering. And we said last year that we were actively exploring, and we continue to actively explore partnerships for all of those.

因此，我們有—因為我們有一系列的祈禱機會，即 CD 70 計劃。我們與合作夥伴加拉巴哥在用戶單元方面保持著持續的合作與夥伴關係，並且我們的肉瘤特許經營業務已擴展到美國以外的地區，所有這些地區均可供合作。我們去年就說過，我們正在積極探索，我們將繼續積極探索與所有這些國家的合作關係。

Moving more broadly, we anticipate that, we will explore all options to be able to, secure the future of the sarcoma franchise and of the company, and just, we anticipate that, the. Properly financed company is our number one priority, as you've seen, the equity capital markets are challenging. Now, the good news is that Tecelra is going as well, if not better than we had envisioned, but that just makes it even more important for to have a properly financed company, and we are exploring all options.

更廣泛地說，我們預計，我們將探索所有選擇，以確保肉瘤特許經營權和公司的未來，而且，我們預計。為公司提供適當的融資是我們的首要任務，如您所見，股權資本市場充滿挑戰。現在，好消息是 Tecelra 的進展不錯，甚至比我們預想的還要好，但這使得擁有一家資金充足的公司變得更加重要，我們正在探索所有的選擇。

This includes the partnerships that you've mentioned and collaborations, it includes strategic combinations, it include the financial transactions and the opportunity to monetize parts of our pipeline as well. So there's a lot of different levers that we are going to explore and that we are exploring in order to ensure that we can bridge through to that successful sarcoma franchise.

這包括您提到的合作夥伴關係和合作，包括策略組合，包括金融交易以及將我們的部分管道貨幣化的機會。因此，我們將探索許多不同的槓桿，以確保我們能夠成功獲得肉瘤特許經營權。

Got it, thanks for taking my questions.

明白了，感謝您回答我的問題。

Thanks, Joan.

謝謝，瓊。

Tony Butler, Rodman & Renshaw.

東尼巴特勒、羅德曼和倫肖。

Good morning, Adrian. Alnd this is probably a question for Cintia. If you actually look at the Tecelra map and realizing that the goal of 30 ATC sites. Obviously, all of them today are in the east, in the south, and out west. So the question is, would the remainder, of course, I assume, be in the Midwest, [Missouri] through I guess [Utah], if you think about it. But also importantly, given the cost comments that you've made, cost reduction comments that you made, is there a notion or a thought that you in fact may need more salespeople? Certainly in that Midwest region. Thanks very much.

早上好，阿德里安。這可能是 Cintia 的一個問題。如果你實際看一下 Tecelra 地圖並意識到 30 個 ATC 站點的目標。顯然，今天它們都在東部、南部和西部。所以問題是，如果你仔細想想，剩下的部分當然會不會在中西部，從[密蘇裡州]到[猶他州]。但同樣重要的是，考慮到您提出的成本評論和成本削減評論，您是否認為您實際上可能需要更多的銷售人員？當然是在中西部地區。非常感謝。

I can adjust the question directly. So, take it, Tony. Yes. So the distribution of the sites was designed based on the concentration of patients that we see in these cancer centers already. So we do expect to see more in the middle of the country, but also the largest concentration. And that's why a lot of the sites are where they are today, that there's a higher concentration of patients there too.

我可以直接調整問題。那麼，接受吧，東尼。是的。因此，站點的​​分佈是根據我們在這些癌症中心已經看到的患者集中度來設計的。因此，我們確實預期在中部地區會看到更多，也是最大的集中地。這就是為什麼許多治療點現在處於這個位置，因為那裡的患者也比較集中。

Our goal with the 30 treatment centers is to be able to provide access in a smoother way to the majority of the patients today. We currently have a footprint that we announced before of five regions with five key commercial leads and five medical leads in the fields, and we are open to exploring opportunities to continue to increase. But at this point we feel that this is the right number of people that we need to provide the right focus on the treatment centers.

我們設立 30 個治療中心的目的是能夠為現今大多數患者提供更順暢的治療服務。目前，我們已經在五個地區建立了業務足跡，並在這些領域擁有五個關鍵的商業領先地位和五個醫療領先地位，我們願意探索繼續擴大業務的機會。但目前，我們認為這是我們需要的正確人數，以便為治療中心提供正確的關注。

Thanks, Cintia.

謝謝，辛西亞。

Graig Suvannavejh, Mizuho Securities USA.

Graig Suvannavejh，美國瑞穗證券。

Thanks. Good morning and thank you for the updates on the launch. And congrats there. I had two questions, relatively brief. Could you just remind us about the commercial strategy? Is it currently right now where your energies are primarily or singularly focused on the US or in other words, can you just remind us what the ex-US, strategy is, that you would think that you would undertake on your own or is it with a partner? And then any timelines on filing in Europe.

謝謝。早安，感謝您提供有關發表會的最新消息。恭喜你。我有兩個問題，比較簡短。您能否提醒我們一下商業策略？目前，您的精力主要或唯一地集中在美國嗎？換句話說，您能否提醒我們，您認為您會獨自實施美國以外的策略，還是與合作夥伴一起實施？然後是有關在歐洲提交申請的任何時間表。

And then secondly, I was just struck just in the press release just on, -- I guess the lack of the financials for the quarter. I realized that the K might come out next week. But that being said, any comments on OpEx in particular. And kind of thoughts around OpEx trends for 2025 given the restructuring, given the goal of achieving profitability in 2027 relative to the uptake for Tecelra. Thanks.

其次，我對新聞稿感到震驚——我想是缺少本季的財務數據。我意識到 K 可能會在下週發布。但話雖如此，特別是對 OpEx 有什麼評論嗎？考慮到重組，考慮到 Tecelra 的吸收量在 2027 年實現盈利的目標，我們對 2025 年的營運支出趨勢有了一些思考。謝謝。

Thanks, Greg. So I'll take the first question on, broader strategies, commercialization strategies on our sarcoma franchise, and then I'll ask Gavin to comment on the costs and the financials. So with respect to the ex-US, our view is that -- it is the absolutely critical thing for us to do is establish a commercially viable, business around our sarcoma franchise in the United States.

謝謝，格雷格。因此，我將回答第一個問題，即我們的肉瘤特許經營的更廣泛的策略、商業化策略，然後我將請加文對成本和財務狀況發表評論。因此，對於美國以外的地區，我們的觀點是——對我們來說絕對關鍵的事情是圍繞我們在美國肉瘤特許經營權建立一個商業上可行的業務。

And that's the number one priority for us from a product commercialization perspective. It is obvious to us that there is demand, outside of the United States. And many people with synovial sarcoma and myxoid liposarcoma who would benefit from Tecelra and from. Lete-cell. And we've been clear for a while that we will explore both opportunities to do that ourselves in territories where that is rational, and also opportunities to part where that is rational, where that makes sense too.

從產品商業化的角度來看，這是我們的首要任務。我們顯然知道，美國以外也有需求。許多患有滑膜肉瘤和黏液樣脂肪肉瘤的人都可以從 Tecelra 中受益。Lete-cell。我們已經明確表示，我們將在合理的領域探索自己做這件事的機會，同時也將在合理的、有意義的領域探索分工的機會。

We can take advantage of other people's infrastructure, et cetera. Nonetheless, the most important thing is that we get the US right, and that's really where all of our focus is internally at the moment. And so whilst we are having discussions with the parties about ex-US strategies, our focus is very clearly on the United States. Gavin, do you want to talk on the financials?

我們可以利用其他人的基礎設施等等。儘管如此，最重要的是我們要正確對待美國，這也是我們目前所有國內關注的重點。因此，雖然我們正在與各方討論非美國戰略，但我們的重點顯然是美國。加文，你想談談財務問題嗎？

Thanks, Graig. With regards to no financials in the earnings released today, given the impact of the restructuring on internal teams and the fact that we've got some new areas for the auditors to consider, including revenue and inventory. We just need a little more time to finish the 10-K off, so we'll be publishing that on Monday. With regards to your forward-looking questions around OpEx in 2025. I'll reiterate what we said at the [Q Corp]. We think the restructuring, will reduce our run rate costs in in 2025 by around about $50 million.

謝謝，格雷格。關於今天發布的收益中沒有財務數據，考慮到重組對內部團隊的影響以及我們有一些新的領域需要審計師考慮，包括收入和庫存。我們只是需要一點時間來完成 10-K，所以我們將在周一發布。關於您對 2025 年營運支出的前瞻性問題。我將重申我們在[Q 公司]。我們認為，重組將使我們 2025 年的營運成本降低約 5,000 萬美元。

Today we've announced that we'll be putting our pre-clinical programs on hold in PRAME and ADP 520. That will drive incremental savings of roughly $75 million to $100 million over the next four years. An element of that is, will be in 2025 and we'll be able to update you in more detail on that at the Q1 earnings call.

今天我們宣布，我們將暫停 PRAME 和 ADP 520 的臨床前計畫。這將在未來四年內帶來約 7,500 萬至 1 億美元的增量節省。其中一個要素是，將在 2025 年實現，我們將能夠在第一季財報電話會議上向您更詳細地介紹這一情況。

Kuan Hung, Wells Fargo Securities.

關鴻，富國證券。

Hi, thanks for taking our questions. This is Kuan Hung for Yanan. So our question is also around Tecelra launch and ATC. So you mentioned that the majority of patients of [apheresed] so far came from majority of them came from the first five ATC. Can you remind us of when those five ATCs became active, and do you expect the additional ATCs to onboard patients as efficiently as those five ATCs? Thank you.

您好，感謝您回答我們的問題。我是關雄，代表延安。所以我們的問題也跟 Tecelra 的發布和 ATC 有關。所以您提到，到目前為止，大多數 [apheresed] 患者來自前五個 ATC。您能否提醒我們這五個 ATC 是何時開始運作的？您是否預期新增的 ATC 能夠像這五個 ATC 一樣有效率地接收病患？謝謝。

Thank you. I can address that question. So those five ATCs were active last year throughout the launch. And we do expect now the ATCs that have been activated this year to bring additional patients. In fact, 85% of the ATCs of the 20 that are already in our website have identified at least one patient The majority of them, multiple patients. And so that's going to continue to grow as we on board and activate more ATCs.

謝謝。我可以回答這個問題。因此，這五個 ATC 在去年的整個發射過程中一直處於活躍狀態。我們確實希望今年啟動的 ATC 能夠接收更多患者。事實上，我們網站上已有的 20 個 ATC 中有 85% 已經識別出至少一名患者，其中大多數識別出多名患者。隨著我們加入並啟用更多 ATC，這一數字將繼續增長。

Got it. Thank you for that. And can you remind us, what percentage of the patient that the first 20 ATCs cover and how about the next 10. Thank you.

知道了。謝謝你。您能否提醒我們，前 20 位 ATC 涵蓋了多少比例的患者，接下來的 10 位又涵蓋了多少比例的患者。謝謝。

So what's happening today is that the patients are, and it's going to continue to happen to a certain extent, the patients can be tested anywhere. So they are being tested locally and then when that patient is a biomarker positive patients for both biomarkers, then they end up getting referred to the treatment centers that are active already.

所以今天發生的情況是，患者可以在任何地方接受檢測，而且這種情況在某種程度上還會繼續發生。因此，他們會在當地接受檢測，然後當該患者的兩種生物標記檢測結果均為陽性時，他們最終會被轉診到已經活躍的治療中心。

So it's hard to calculate a number of patients per ATC because that referral pattern is being established as we activate the ATCs, but certainly the proximity to the patients and the proximity to where the referral sites are, is going to make it easier for patients to get to the treatment centers, -- the more treatment centers we have. Does that answer your question?

因此很難計算每個 ATC 的患者數量，因為轉診模式是在我們啟動 ATC 時建立的，但可以肯定的是，距離患者較近以及距離轉診點較近，將使患者更容易到達治療中心——我們擁有的治療中心越多。這回答了你的問題嗎？

Yes, that's helpful. Thank you so much.

是的，這很有幫助。太感謝了。

No, thank you.

不，謝謝。

George Farmer, Scotia Bank.

加拿大豐業銀行的喬治法默。

Hi, good morning. Thanks for taking my questions. First one is on your ex-US efforts, this was touched on earlier, but are you actively engaging in the process of trying to filing in the EU? Or is that on hold and realistically, when do you think this drug could be available [Lete-cel] therapy could be available in Europe. And my second question relates to, PRAME and CD70, can you talk about any level of outside interest in these programs? And do you think that those programs could be monetized in any way in the near future? Thanks.

嗨，早安。感謝您回答我的問題。第一個是關於您在美國以外的努力，我們之前已經提到過，但是您是否積極參與嘗試在歐盟提交申請的過程？或者是暫時擱置，從現實角度來說，您認為這種藥物 [Lete-cel] 療法什麼時候可以在歐洲上市。我的第二個問題與 PRAME 和 CD70 有關，您能談談外在對這些項目的興趣程度嗎？您認為這些項目在不久的將來能以某種方式貨幣化嗎？謝謝。

I was going to say we haven't provided timelines for the ex-US, filing, et cetera. But I would like to ask Dennis, to comment on, the regulatory position and development position there, particularly for the EU.

我想說的是，我們還沒有提供美國以外的備案時間表等等。但我想請丹尼斯評論那裡的監管立場和發展立場，特別是歐盟的監管立場和發展立場。

Thanks, Ad. So we have for Tecelra, we are part of the prime scheme in Europe for this program. We have all the things that you would typically do pre-approval in advance of marking applications. So we have an agreed pediatric investigational plan. We have [from]drug designation. For a variety of strategic reasons to make a stronger application, we're more likely to go in with the full trial results, meaning cohorts one, two, and three of the spearhead one trial.

謝謝，Ad。因此，對於 Tecelra 來說，我們是該專案在歐洲的主要計劃的一部分。我們已做好您在標記申請之前通常需要預先批准的所有事情。因此我們有一個商定的兒科研究計劃。我們有[來自]藥物名稱。基於各種策略性原因，為了讓申請更有力，我們更有可能採用完整的試驗結果，即先頭試驗的第一、二和三組。

So as right, we're looking to conclude our confirmatory evidence later this year. So we're going to report out the results of cohorts two and three in the third quarter, and we have the totality of data that's independent of the launch activities in Europe. That's really the strategy we would go in with a marketing application in Europe if the decision was to pursue that.

因此，我們希望在今年稍後得出確認證據。因此，我們將在第三季報告第二批和第三批的結果，並且我們擁有獨立於歐洲發布活動的全部數據。如果決定實施的話，這確實是我們在歐洲實施行銷應用程式時要採取的策略。

Thanks, Dennis. And with respect to, your other question, I mean, the PRAME and CD70, I mean, both of those program’s target, what I generally regarded in the industry as a very high value, large opportunity targets. And they are already of interest to a range of farmer companies, and other large and small biotech's who have programs in this space.

謝謝，丹尼斯。關於您的另一個問題，我的意思是，PRAME 和 CD70，這兩個項目的目標，我通常認為在業內具有非常高的價值，具有巨大的機會目標。它們已經引起了一系列農業公司以及在該領域開展專案的其他大型和小型生物技術公司的興趣。

And so we continue to believe that -- and we have ongoing discussions, that, those are likely to be valuable programs for us. However, I will refer to my comments in the scripted portion of this call that we are exploring all opportunities for, in order to be able to enable us to be successful with our sarcoma franchise that includes those partnerships.

因此，我們繼續相信——並且我們正在進行討論，這些對我們來說可能是有價值的項目。不過，我將在本次電話會議的腳本部分中引用我的評論，即我們正在探索所有機會，以便能夠讓我們在包括這些合作夥伴關係在內的肉瘤特許經營方面取得成功。

It includes, other collaborations, strategic combinations, other financial transactions, and monetization opportunities as well. And we have a lot of those levers that we can pull and we will give updates when we have, something tangible to talk about.

它還包括其他合作、策略組合、其他金融交易和貨幣化機會。我們有許多可以利用的手段，當我們有實際可行的事情可以談時，我們會提供最新消息。

Okay, thanks, Adrian.

好的，謝謝，阿德里安。

Yes.

是的。

Arthur He, HC Wainwright.

亞瑟·何，HC·溫賴特。

Hey, good morning, and the team. Thanks for taking my question. So I apologize if this question has been addressed before. So could you give us more color on the patient number has been identified by market eligible so far during this year.

嘿，早上好，團隊。感謝您回答我的問題。如果這個問題之前已經得到解答，我深感抱歉。那麼，您能否向我們詳細介紹今年迄今符合市場條件的患者人數？

So, maybe I'll ask Cintia to comment on that.

所以，也許我會請 Cintia 對此發表評論。

Yes, I can address that. We, in addition to the 10 patients that have been A3, we do have line of sight for about 20 other patients that are double positive and are going to be getting into the journey moving forward. We see a lot of excitement from the sites with the launch and now the availability of this new option for patients in an area that has not had any innovation. So we see excitement in sites becoming treatment centers but also with the other sarcoma centers of excellence in identifying and testing patients.

是的，我可以解決這個問題。除了 10 名 A3 患者外，我們還關注到另外約 20 名雙重陽性患者，他們即將踏上治療之旅。我們看到，隨著這項服務的推出，各站點都感到非常興奮，現在，這項新選擇可以為那些還沒有任何創新的地區的患者提供。因此，我們看到這些站點不僅成為治療中心，而且也成為其他肉瘤中心在識別和檢測患者方面的卓越中心，這令人興奮。

Thank you. And just a quick follow up. So to date, what's the roughly conversion rate from the double positive patient to get the [apheresed]?

謝謝。並進行快速跟進。那麼到目前為止，雙重陽性患者到獲得[已分析]？

So it's more a matter of time than percentage. And so each patient has a very different journey, so it can take different timings for them to be able to get through insurance approval, schedule it freezes, and go through the process. It's just two very, low numbers at this time for us to be able to calculate any very specific statistics, but the majority of them are going through the journey in a overtime.

所以這更多的是時間問題而不是百分比問題。因此，每個病人的治療過程都非常不同，因此他們可能需要不同的時間才能獲得保險審批、安排凍結並完成整個過程。目前，這兩個數字非常低，我們無法計算出任何非常具體的統計數據，但其中大多數都是在加時賽中完成的。

Than you. Very helpful. Thanks for taking my question.

比你還好。非常有幫助。感謝您回答我的問題。

Michael Kim, Zacks Small-Cap Research

Michael Kim，Zacks 小型股研究公司

Hey everyone, good morning. Thanks for taking my questions. First, just curious to get your perspective on, the incremental $75 million to $100 million of savings related to pausing on PRAME and CD70 just in terms of. You know how these incremental savings impact the anticipated timeline for reaching an inflection in operating profitability.

大家好，早安。感謝您回答我的問題。首先，我只是好奇地想聽聽您對暫停 PRAME 和 CD70 所帶來的 7500 萬至 1 億美元增量節省的看法。您知道這些增量節省如何影響實現營運獲利拐點的預期時間表。

So thanks, Michael. So clearly those incremental savings will help accelerate that time to profitability, but there are a number of other variables involved in that, including successful launch of Tecelra and the acceleration and ramping that we're already seeing, though of course we're four or five months into this, the launch of Lete-cel be important part of that as well. So a number of variables but continue to focus on our cost base and being judgmental about where we put our assets to work will clearly help in expediting that voyage to profitability.

所以謝謝你，麥可。因此，顯然這些增量節省將有助於加快盈利時間，但這其中還涉及許多其他變量，包括成功推出 Tecelra 以及我們已經看到的加速和提升，當然我們已經進行了四五個月，Lete-cel 的推出也是其中的重要組成部分。因此，儘管存在許多變量，但繼續關注我們的成本基礎並判斷我們的資產用途顯然有助於加快盈利進程。

Got it. Okay. And then, appreciate the commentary on let us sell in terms of initiating the BLA later this year with an anticipated approval in '26 which I think would represent a meaningfully shorter timeline with respect to the process for Tecelra.

知道了。好的。然後，感謝您對讓我們出售的評論，即在今年稍後啟動 BLA，預計在 26 年獲得批准，我認為這對於 Tecelra 的流程來說將代表一個更短的時間表。

So just curious to get your thoughts on where you might be able to leverage your experience with Tecelra to drive synergies or efficiencies. And then what's, what sort of timeline are you building in for FDA approval once you complete the BLA? Thanks.

所以我很好奇地想知道您認為如何利用您在 Tecelra 方面的經驗來推動協同效應或提高效率。那麼，一旦完成 BLA，您會為獲得 FDA 批准制定什麼樣的時間表？謝謝。

Thanks, Michael. I'm going to ask Dennis to talk about the how the learnings from Tecelra have built into our plans for Lete-cel and the path to approval. And then maybe I'll ask Cintia to talk about how we anticipate the launch of Lete-cel in the context of a fully established commercial organization and treatment network, that we've established with Tecelra .

謝謝，麥可。我將請丹尼斯談談 Tecelra 的經驗如何融入我們對 Lete-cel 的計劃以及獲得批准的途徑。然後，我可能會請 Cintia 談談我們如何在與 Tecelra 建立的完善的商業組織和治療網絡的背景下預期推出 Lete-cel。

Dennis do you want to go first?

丹尼斯，你想先走嗎？

Yes, sure. Thanks, Ad. There are a lot of learnings that that we have from the Tecelra BLA review and approval that, we've already incorporated into the planning of the Lete-cel BLA as we prepare it so they could be on the clinical side just or the CMC side things that the FDA going through that process. But essentially the same patient population that they would expect to see as far as planning around the companion diagnostics and having contemporaneous approvals. So all those learnings will be applied.

是的，當然。謝謝，Ad。我們從 Tecelra BLA 審查和批准中獲得了很多經驗，在準備 Lete-cel BLA 時，我們已經將這些經驗融入到計劃中，以便它們可以只在臨床方面，或者在 FDA 經歷的 CMC 方面。但就伴隨診斷的規劃和同時批准而言，他們期望看到的患者群體基本上是相同的。因此，所有這些學習成果都將被應用。

Now, to your question about the FDA review period. We have a breakthrough therapy designation for both indications for Lete-cel, both for synovial sarcoma and more recently that we received for myxoid/round cell liposarcoma. That application, that breakthrough therapy designation was based on the results of the IGNYTE [ESO]-cell, right? So the FDA has already seen some of the data from the pivotal trial.

現在，回答您關於 FDA 審查期的問題。我們對 Lete-cel 的兩種適應症都獲得了突破性治療稱號，一種是滑膜肉瘤，另一種是最近獲得的黏液樣/圓細胞脂肪肉瘤。該應用、此突破性療法的稱號是基於 IGNYTE [ESO] 細胞的結果，對嗎？因此，FDA 已經看到了一些關鍵試驗的數據。

But as these designations grant a lot of avenues to expedite development. Among them is the rolling review, which we intend to pursue that, and we'll start that process at the end of the year. We would also be eligible for a priority review and a priority review for this application would essentially be eight months. So this is some of the timings that go into the plan where we would expect approval at the end of next year.

但這些指定為加快發展提供了許多途徑。其中包括滾動審查，我們打算推行這項措施，並將於今年底啟動此流程。我們還有資格獲得優先審查，而該申請的優先審查時間基本上為八個月。這是計劃中的一些時間安排，我們預計該計劃將於明年年底獲得批准。

And then Cintia, I think you're going to have some additional comments about the launch activities.

然後，辛西婭，我想你會對發布活動有一些補充評論。

Yes, thank you, Dennis. So from a commercial perspective, as you would imagine, there's a lot of synergies. So initially targeted therapy in sarcoma is something new. So testing patients is something that is being established right now for Tecelra. And that's going to be established when we bring Lete-cel on board. It's going to be a different target. But the paradigm of testing patients for sarcoma is going to be established.

是的，謝謝你，丹尼斯。因此，從商業角度來看，正如您所想像的，存在著許多協同效應。因此，最初針對肉瘤的標靶治療是一種新事物。因此，對患者進行測試是 Tecelra 目前正在進行的工作。當我們引入 Lete-cel 時，這一點就會實現。這將是一個不同的目標。但對患者進行肉瘤檢測的範例即將建立。

The ATC network is going to be available and a lot easier to just pick up on Lete-cel. So commercial platform is in place in terms of ordering and all of the chain of custody and identity process is all established already. And we do have a small commercial team, but really, we're very proud of the team that is in the fields across both medical and commercial.

ATC 網路即將投入使用，透過 Lete-cel 接收將變得更加容易。因此，商業平台在訂購方面已經到位，並且所有的監管鍊和身分流程都已經建立。我們確實有一個小型商業團隊，但實際上，我們對這個橫跨醫療和商業領域的團隊感到非常自豪。

They're very experienced in working with the sites, and the customer overlap with lace, it's 100%. So we're going to leverage exactly the same network and commercial footprint, medical footprints that we have in place at this time. So a lot of synergies with Lete-cel .

他們在網站建立方面經驗非常豐富，客戶與蕾絲的重疊率高達 100%。因此，我們將利用目前已建立的完全相同的網路和商業足跡以及醫療足跡。因此與 Lete-cel 有很多協同作用。

Great, very helpful. Thanks for taking my questions.

非常好，很有幫助。感謝您回答我的問題。

Thank you.

謝謝。

(Operator Instructions) Peter Lawson, Barclays.

（操作員指示）巴克萊銀行的彼得·勞森。

Great, thanks for the update. Thanks for taking the questions. Just on the ATCs that are actively infusing patients. How many have infused more than one patient? And what percentage of those ATCs are actively infusing and then just your confidence level around kind of whether it's meeting or exceeding that target of 30 centers by year end.

太好了，謝謝更新。感謝您回答這些問題。僅在積極為病人輸液的 ATC 上。有多少人給多個病人輸血？這些 ATC 中有多少比例正在積極注入，然後您對它是否達到或超過年底前 30 個中心的目標的信心水平如何。

Cintia?

辛西亞？

I can address that. So the as I mentioned before, like about five ATCs have been the ones responsible for the patients that have been freezing so far. We do have ATCs that infused more than one patient. And the pace in which the ATCs are enrolling patients and Having patients be free is exactly as what we would expect.

我可以解決這個問題。正如我之前提到的，到目前為止，大約有五名 ATC 對患者凍傷負有責任。我們確實有為多位病患輸液的 ATC。ATC 接收病患和病患免費的速度正是我們所期望的。

The pace of onboarding ATCs has actually been a little faster than what we expected based on prior experiences. And I attribute that really to the excitement of the sarcoma specialists to be able to offer this new treatment option for their patients. So and also the fact we learned a lot from The prior cell therapy programs, we had a lot of conversations with our treatment centers to make sure that we implemented an onboarding process that was as simple as it could possibly be.

根據以往的經驗，空中交通管制員的入職速度實際上比我們預期的要快一些。我認為這真的要歸功於肉瘤專家們為能夠為患者提供這種新的治療選擇而感到的興奮。因此，事實上我們從先前的細胞治療計劃中學到了很多東西，我們與治療中心進行了許多對話，以確保我們實施的入職流程盡可能簡單。

And having a team that is very focused and customized to meet the needs of these customers in a way that the process is as simple as it can be expedited and we can troubleshoot very specifically as needed.

我們擁有一支非常專注且客製化的團隊來滿足這些客戶的需求，讓流程盡可能簡單、加快，並且我們可以根據需要非常具體地排除故障。

Great, thank you. And then are there any capacity constraints or manufacturing bottlenecks that could potentially limit the patient infusions you need to kind of hit the 2025, and also that 2027 profitability number.

太好了，謝謝。那麼是否存在產能限製或製造瓶頸，可能會限制實現 2025 年和 2027 年獲利數字所需的患者輸液量。

We have not seen any capacity limitations so far, not on our manufacturing side, not on the site side as well in terms of a beds and maybe John, can comment on this as well. But we, our capacity is enough to reach all of our goals. But John, want to comment on it.

到目前為止，我們還沒有看到任何產能限制，無論是在製造方面，還是在場地方面，就床位而言，也許約翰也可以對此發表評論。但我們的能力足以實現我們所有的目標。但是約翰，我想對此發表評論。

Sure, thanks Cintia. Absolutely, I think some of the challenges that we've perhaps seen in other CAT launches that we've learned from have put us in a position where we don't have capacity constraints. Adrian mentioned that we've and exceeding our targets of the 30-day time from the freezer collection to release.

當然，謝謝 Cintia。當然，我認為我們在其他 CAT 發布中可能遇到一些挑戰，我們從中吸取了教訓，使我們處於沒有容量限制的境地。阿德里安提到，我們已經超額完成了從冷凍收集到發布的 30 天目標。

And he also mentioned that while it's a small number, we've had a 100% success rate thus far with our commercial, which is of course both of those are different than what you've seen in other cars. So it just gives us continued confidence that we've set this up right for a successful launch and ultimately on the way to sell as well.

他還提到，雖然數字很小，但到目前為止，我們的商業廣告成功率已達到 100%，這當然與您在其他汽車上看到的不同。因此，這讓我們繼續充滿信心，我們已經為成功推出和最終銷售做好了正確的準備。

Gotcha. Thank you. I know it's hard to, kind of break out individual components, but for that cost savings from PRAME and CD70 and headcount reduction. What proportion of that is kind of folded into the commercial roll out versus extending the cash runway?

明白了。謝謝。我知道很難將各個組件分開，但 PRAME 和 CD70 可以節省成本並減少員工人數。其中有多少比例納入商業推廣，有多少比例被延長現金跑道？

Gavin?

加文？

I think you're right when you say it's difficult to break those components at the moment, we'll certainly give a further update to the one earnings update. But we are absolutely focused on successful commercial launch and applying resources appropriately to support what's been so far a very successful launch of Tecelra.

我認為你說得對，目前很難打破這些組成部分，我們肯定會對一份收益更新進行進一步的更新。但我們絕對專注於成功的商業發布，並適當運用資源來支持迄今為止非常成功的 Tecelra 的發布。

Right. Thank you so much. Good luck going forward.

正確的。太感謝了。祝你未來好運。

Thanks Peter.

謝謝彼得。

And ladies and gentlemen, with that, we'll be concluding today's question-and-answer session. I'd like to turn the floor back over to Adrian Rawcliffe for closing remarks.

女士們、先生們，今天的問答環節就到此結束。我想把發言權交還給 Adrian Rawcliffe，請他做最後發言。

Thanks and thank you everybody for your questions. As I think we've demonstrated, we have great traction and acceleration on the launch of Tecelra. And I'm really looking forward to being able to update you on that as we move through the year and also on the progress towards the BLA for Lete-cel.

謝謝，也謝謝大家的提問。我認為我們已經證明，我們在 Tecelra 的推出上具有巨大的牽引力和加速度。我非常期待能夠在新的一年向您通報這一情況以及 Lete-cel 的 BLA 的進展。

We will continue to manage the cost base, we will continue to push forward through to profitability in 2027. And we will leave no stone unturned to enable us to achieve that, from a financing perspective. And, with that, I'll close the call. Thank you all for your questions and your interest.

我們將繼續管理成本基礎，並將繼續努力，到 2027 年實現盈利。從融資角度來看，我們將竭盡全力實現這一目標。好了，我這就結束通話。感謝大家的提問與關注。

This brings to a close today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.

今天的電話會議到此結束。您可以斷開線路。感謝您的參與並祝您有個愉快的一天。