Autolus Therapeutics PLC (AUTL) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Autolus first quarter, 2025 financial results conference call.

您好，感謝您的支持。歡迎參加 Autolus 2025 年第一季財務業績電話會議。

(Conference Instructions)

（會議指示）

I would not like to hand the conference over to your speaker today, Amanda Cray, executive director of investor relations. Please go ahead.

我不想把今天的會議交給你們的發言人、投資者關係執行董事阿曼達·克雷 (Amanda Cray)。請繼續。

Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me our Chief Executive Officer, Doctor Christian Itin, and Chief Financial Officer, Rob Dolski.

大家早安或下午好，感謝您參加今天的電話會議。與我一起的是我們的執行長 Christian Itin 博士和財務長 Rob Dolski。

I'd like to remind you that during today's call we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

我想提醒大家，在今天的電話會議上，我們將根據聯邦證券法和 1995 年《私人證券訴訟改革法案》的安全港條款做出與我們業務相關的前瞻性聲明。

These may include but are not limited to statements regarding status of the ongoing commercial launch of AUCATZYL in the US. Autolus manufacturing, sales and marketing plans for AUCATZYL, the market potential for AUCATZYL, and the status of clinical trials, development, and or regulatory timelines and market opportunities for obe-cel and our other product candidates.

這些可能包括但不限於有關 AUCATZYL 在美國正在進行的商業發布的狀況的聲明。Autolus 對 AUCATZYL 的製造、銷售和行銷計劃、AUCATZYL 的市場潛力以及 obe-cel 和我們其他候選產品的臨床試驗、開發和/或監管時間表和市場機會的狀態。

These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the investor section of our website.

這些聲明受各種風險和不確定性的影響，可能導致實際結果與預期有重大差異，並且僅反映我們截至今天的觀點。我們不承擔更新任何此類前瞻性陳述的義務。有關可能影響我們實際結果的重大風險和不確定性的討論，請參閱今天的新聞稿和我們的美國證券交易委員會文件中確定的風險，這兩份文件都可以在我們網站的投資者部分找到。

Turning to slide three, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll then take questions. With that, I'll turn it over to Christian.

翻到第三張投影片，你會看到今天電話會議的議程。與往常一樣，克里斯蒂安將概述我們的營運亮點。隨後，羅布將討論財務結果，克里斯蒂安將總結即將到來的里程碑並發表結束語。然後我們將回答問題。說完這些，我就把話題交給克里斯蒂安。

Thank you very much, Amanda, and welcome everybody to our first quarter 2025 results.

非常感謝，阿曼達，歡迎大家關注我們 2025 年第一季的業績。

First off, we had a great first quarter. The launch has been off to a really good start. We have seen a substantial level of interest by the physicians in the product profile. Clearly there is a significant unmet need for the patients with lapsed refractory acute lymphoblastic leukemia. And we're very pleased to report $9 million in recognized revenue in the first quarter.

首先，我們第一季表現非常出色。此次發布會開局十分順利。我們發現醫生對該產品表現出了相當大的興趣。顯然，對於復發性急性淋巴性白血病患者來說，存在著巨大的未滿足需求。我們非常高興地報告第一季確認的收入為 900 萬美元。

Obviously foundational to the ability to really reach the patients is that we have to be present in the respective clinical centers. And as of yesterday we have 39 centers that are authorized to deliver or AUCATZYL. This is a great accomplishment from our onboarding and market access team, and we're currently at a level of about 90% of total US medical lives covered, which is a great position this early in a product launch.

顯然，真正接觸到患者的基礎是我們必須出現在相應的臨床中心。截至昨天，我們已有 39 個中心被授權提供 AUCATZYL。這是我們的入職和市場准入團隊取得的一項偉大成就，目前我們的覆蓋範圍已達到美國醫療總人口的 90% 左右，這在產品發布的初期是一個很好的成績。

As of April 1, CMS also published the codes for in and outpatient use for government patients on government programs, and with that we have now an ability to get AUCATZYL also be eligible for reimbursement for patients on government programs, in addition, obviously to the patients who have been covered and are covered through the commercial programs. So, this sets us up in a really good way leading into the second quarter, and we're excited about the initial momentum that we've seen in Q1 and see that very nicely carried over into the second quarter.

截至 4 月 1 日，CMS 還公佈了政府項目中政府患者的住院和門診使用代碼，有了這些代碼，我們現在就可以讓 AUCATZYL 有資格獲得政府項目中患者的報銷，此外，顯然那些已經獲得覆蓋並通過商業項目獲得覆蓋的患者也可以獲得報銷。因此，這為我們進入第二季度做好了非常好的準備，我們對第一季度看到的初步勢頭感到興奮，並看到這種勢頭很好地延續到了第二季度。

With that, I'd like to move to slide number five. When we look at the opportunities for growth, obviously the first opportunity is in the US, and one of the key things that we're planning to do from here on to the year end is really increase the number of centers that are activated and in a position to the liver AUCATZYL therapy. We're going to go from what's now 39 centers to approximately 60 centers, which will give us approximately 90% access to patients across the US. So that's also critical, and one of the key things that we're going to see as we go through the course of this year is also that we're looking to build additional momentum and drive and support the launch going forward also with additional data updates.

接下來我想轉到第五張投影片。當我們尋找成長機會時，顯然第一個機會是在美國，從現在到年底我們計劃要做的關鍵事情之一就是真正增加已啟動並能夠進行肝臟 AUCATZYL 治療的中心數量。我們的中心數量將從現在的 39 個增加到大約 60 個，這將使我們能夠覆蓋全美約 90% 的患者。所以這也很關鍵，我們在今年看到的關鍵事情之一就是我們希望建立額外的動力，並透過額外的數據更新來推動和支持未來的發布。

A key update is planned for this quarter. Based on long term follow up from the FELIX study, which I believe will be very encouraging and very helpful to understand the impact that can have as a single agent in this relaxed and refractory patient population. So, first push I would say in the US also actually driving certainly as we go into next year to start expanding the market share for CAR T products and then gradually build from there. Now the second layer of expansion that we're looking at is a geographic expansion.

本季計劃進行一次重要更新。根據 FELIX 研究的長期跟踪，我相信這將非常令人鼓舞，並且非常有助於了解其作為單一藥物對這種緩解和難治性患者群體的影響。因此，我想說，首先在美國，我們也會大力推動，因為明年我們將開始擴大 CAR T 產品的市場份額，然後從那裡逐步發展。現在，我們正在考慮的第二層擴張是地理擴張。

We reported about a good week ago that we have received conditional marketing authorization from the MHRA in the UK and are now in the process of engaging with NICE and the other relevant bodies in the UK to get the product actually through the reimbursement and access process and then into the launch in the UK. In Europe we're progressing well, and we expect to receive a decision by the European Agency in the second half of this year.

大約一周前，我們報告稱，我們已獲得英國 MHRA 的有條件上市許可，目前正在與 NICE 和英國其他相關機構合作，以使產品真正通過報銷和獲取流程，然後在英國上市。在歐洲，我們的進展順利，預計將在今年下半年收到歐洲機構的決定。

From a European perspective, then we will initially are planning to launch in Germany and then actually move gradually from there obviously with various different processes that we have in Europe related to pricing and reimbursement, which has a big impact on the sequence and how to actually progress in Europe. Now looking beyond, the immediate launch and the geographic expansion, we also believe that the product has additional opportunities in acute lymphoblastic leukemia. Right now we have the data set in the relapsed refractory population.

從歐洲的角度來看，我們最初計劃在德國推出，然後從那裡逐步推進，顯然我們在歐洲採用與定價和報銷相關的各種不同流程，這對順序以及如何在歐洲實際進展有很大影響。現在，除了立即推出和地理擴張之外，我們還相信該產品在急性淋巴細胞白血病方面還有其他機會。目前，我們擁有復發難治性族群的資料集。

This is obviously these are patients that are already. Gone through a very significant amount of exposure. They've been typically up to three years of frontline therapy, have gone through high dose chemotherapy. Many of them have received other agents, targeted agents, as well as might have received stem cell transplants. So, this is a very advanced population. What we do know from obe-cel and AUCATZYL is that the product.

顯然，這些都是已經生病的病人。經歷了大量的曝光。他們通常接受長達三年的第一線治療，並接受過高劑量的化療。他們中的許多人已經接受過其他藥物、標靶藥物治療，甚至可能接受過幹細胞移植。所以，這是一個非常先進的群體。我們確實從 obe-cel 和 AUCATZYL 了解到該產品。

When used in patients that are in the earlier stages of relapse and also patients that have lower tumor burden at the time of therapy, the patients do better with those profiles, and we believe one of the key areas that I think is important to explore. Is the utility of the product ultimately in a frontline consolidation setting we will start to explore the exploration of frontline settings through investigator sponsored trials and we'll certainly consider our steps in addition to those.

當用於復發早期階段的患者以及治療時腫瘤負擔較低的患者時，患者的療效會更好，我們認為這是值得探索的關鍵領域之一。該產品的實用性最終是否在前線鞏固環境中，我們將開始透過研究者贊助的試驗來探索前線環境，我們肯定會考慮除此之外的步驟。

In addition, when we look at the pediatric population, we're currently treating pediatric patients, and we're planning an update and results to be presented by the end of the year, and we also will review whether there's an opportunity for us to move obe-cel also forward in the pediatric setting and hopefully find a way to make the product accessible to patients in this setting as well. Now, moving to slide number six, Obviously, what we do have with obe-cel is an ability to target the entire B cell compartment, and there's quite a significant additional set of opportunities that we do have with the product that we can see beyond acute lymphoblastic leukemia.

此外，當我們關注兒科族群時，我們目前正在治療兒科患者，我們計劃在年底前發布更新和結果，我們還將審查是否有機會在兒科環境中推動 obe-cel 的發展，並希望找到一種方法讓這種環境下的患者也能使用該產品。現在，轉到第六張幻燈片，顯然，obe-cel 具有針對整個 B 細胞區室的能力，而且除了急性淋巴細胞白血病之外，我們還看到了該產品的許多額外機會。

So moving to slide seven, briefly summarizing our current experience with obe-cel across a range of indications. Obviously, you're all aware and you're very well familiar with the products profile in the relapsed or refractory adult population, obviously as presented as well and published in the New England Journal for the FELIX study. But we also obviously have earlier data on pediatric patients as well. What we do see across all of these trials that we've conducted both with our academic partners at UCL as well as the subsequent trials. We do see consistently that the product actually achieves very deep MRD-negative responses, or to put it differently, the product has an ability to reset the compartment in a very profound way.

現在轉到第七張投影片，簡要總結我們目前在一系列適應症中使用 obe-cel 的經驗。顯然，大家都知道並且非常熟悉該產品在復發或難治性成年人群中的表現，這顯然也是在《新英格蘭醫學雜誌》上介紹和發表的 FELIX 研究成果。但我們顯然也擁有關於兒科患者的早期數據。我們與倫敦大學學院的學術合作夥伴進行的所有這些試驗以及後續試驗都表明了這一點。我們確實始終看到該產品確實實現了非常深的 MRD 陰性反應，或者換句話說，該產品能夠以非常深刻的方式重置隔間。

The profound way is also shown with the experience we had in the old CAR T 19 study initially where we have more than five years of follow up as well as the FELIX study where we're going to, as mentioned, give an update on long term outcome later this quarter. We're also seeing the ability. The product to get a proportion of the patients into long term remission, clearly indicating that we had an ability to make an extremely deep cut into the compartment and completely remove the acute leukemia cells.

這種深刻的方式也體現在我們最初在舊 CAR T 19 研究中獲得的經驗中，在該研究中我們進行了五年多的跟踪，以及 FELIX 研究，正如所提到的，我們將在本季度晚些時候更新長期結果。我們也看到了這種能力。該產品使一部分患者獲得長期緩解，這清楚地表明我們有能力在隔間中形成極深的切口並徹底清除急性白血病細胞。

Now this is the experience in leukemia. We have very similar outcomes that we have observed in patients with non-Hodgkin lymphoma, which is part of the CAR T 19 extension study. And what we've seen in that setting is very high levels of metabolic complete remissions. And when we look at the large B cell lymphoma patients in those cohorts, those patients do actually have also the majority of the of those patients have long term outcomes as well. So quite clearly a very deep activity. What we also see is that the safety profile that we have in acute leukemia is very favorable.

這就是白血病的經驗。我們在非何杰金氏淋巴瘤患者中觀察到的結果非常相似，這是 CAR T 19 擴展研究的一部分。在那種情況下，我們看到代謝完全緩解的水平非常高。當我們觀察這些群體中的大型 B 細胞淋巴瘤患者時，我們發現這些患者中的大多數也確實具有長期療效。顯然這是一項非常深奧的活動。我們也發現，我們在治療急性白血病的安全性非常好。

Remember, we did not actually have, we do not have an obligation for a [renal] for AUCATZYL in the lapse refractory at all. But when we then look into the lymphoma patients, the profile actually improves further. We have no high-grade cytokine release syndrome in those patients, and we have not actually observed neurological toxicities or ICANS in that population as well. So, when we think about this profile and where we can actually where a deep cut in the compartment can make a big impact on outcomes, there's sort of two key areas to focus on:

請記住，我們實際上沒有，我們根本沒有義務對 AUCATZYL 的失效抗藥性進行 [腎臟] 治療。但當我們研究淋巴瘤患者時，情況實際上進一步改善。在這些患者中我們沒有發現高級別細胞因子釋放綜合徵，我們實際上也沒有在該族群中觀察到神經毒性或 ICANS。因此，當我們思考這個概況以及我們實際上可以在何處對隔間進行深度削減會對結果產生重大影響時，有兩個關鍵領域需要關注：

One, I already mentioned is the frontline consolidation in aggressive B cell malignancies, where we aim for long-term outcomes while avoiding overtreatment of these patients. What we've seen so far is just add-on strategies and we keep adding more and more toxicity in these patients. However, we start to see sort of diminishing returns and in fact at times negative outcomes from adding additional toxicity. So getting to much more compact treatment, shortening treatment, and get to long-term outcomes has to be an objective going forward.

我已經提到過，其中之一就是侵襲性 B 細胞惡性腫瘤的第一線鞏固治療，我們的目標是獲得長期療效，同時避免對這些患者進行過度治療。到目前為止，我們所看到的只是附加策略，我們不斷在這些患者身上添加越來越多的毒性。然而，我們開始看到收益遞減，事實上，有時增加額外的毒性還會產生負面結果。因此，實現更緊湊的治療、縮短治療時間並獲得長期效果必須成為未來的目標。

The second area is obviously the wide range of B cell mediated autoimmunity where we've seen some quite remarkable data from Georg Schett's team in Erlangen indicating that indeed if you do have a deep cut in the compartment, you can actually transform the outcomes for these patients and those outcomes appear to be sustainable. So the goal in those indications is to really get sustained effects with a one-time intervention. And that obviously is a very attractive proposition in those disease settings.

第二個領域顯然是廣泛的 B 細胞介導的自身免疫，我們從埃爾蘭根的 Georg Schett 團隊那裡看到了一些非常了不起的數據，這表明如果你確實在這個隔間中進行了深入的切割，你實際上可以改變這些患者的治療結果，而且這些結果似乎是可持續的。因此，這些指示的目標是透過一次性幹預真正獲得持續的效果。顯然，在這些疾病環境中，這是一個非常有吸引力的主張。

So with that, I'd like to just on slide eight briefly just talk about autoimmune disease and the fact that we're looking at when we look at particularly advanced patients, we have on the one hand, An inflammatory process where you have antigen and B cell engagement as well as T cell engagement that sort of form a loop of activity that actually is a very visual forms a very visual cycle and continuously actually drives an inflammatory process in these patients.

因此，我想在第八張幻燈片上簡要地談談自體免疫疾病，事實上，當我們觀察特別晚期的患者時，一方面，我們看到一種發炎過程，其中有抗原和 B 細胞參與以及 T 細胞參與，形成一種活動循環，這實際上是一個非常直觀的循環，並持續驅動這些患者的發炎過程。

The auto reactive antibodies obviously have then an ability to recruit immune cells and complement onto tissue and on into organs and actually start to create damage on that tissue. If that prolongs, you start to actually get scarring in the tissue. You get scarring and loss of function in those organs, and you can have very dramatic effects and issues that these patients do build up over time.

自體反應抗體顯然具有募集免疫細胞和補充組織及器官的能力，並且實際上開始對組織造成損害。如果這種情況持續下去，組織上就會開始出現疤痕。這些器官會留下疤痕並喪失功能，隨著時間的推移，這些患者可能會出現非常嚴重的影響和問題。

The treatment is basically various forms of immune suppression that you run in these patients and that also in their own right actually have significant drive significant adverse events and unfortunately for most, for many of these patients do not actually address the underlying disease in a way that allows these patients to live normal lives.

治療基本上是對這些患者進行各種形式的免疫抑制，而這些免疫抑製本身實際上也會導致嚴重的不良事件，不幸的是，對於大多數患者來說，許多患者實際上並沒有以允許他們過上正常生活的方式解決潛在疾病。

So when we look at the ability for B cells to really target this type of therapeutic intervention, it gives you an ability to really block that cycle, crack it open, remove the B cell component that carry memory, remove the plasma blasts which express the other antibodies, and with that actually stop this vicious cycle of continuous activation and continuous damage in these patients.

因此，當我們研究 B 細胞真正針對此類治療幹預的能力時，它使您能夠真正阻止該循環，打破它，去除攜帶記憶的 B 細胞成分，去除表達其他抗體的漿母細胞，從而真正阻止這些患者體內持續激活和持續損害的惡性循環。

Now, the patients that we're looking for, particularly from a CAT perspective, are patients that do actually have disease that is advanced, disease that already actually shows impact on, organs, particularly organs like the kidney, and so these are patients that do have an element of structural damage. Now, there is, when we think about the impact of the therapy. Clearly, we expect the therapy to have an immediate impact on the inflammatory process and the inflammatory parameters, as well as a lot of the manifestations that we see in these in these diseases, and I'll talk in the next slide about the various types of forms of disease that these patients.

現在，我們正在尋找的患者，特別是從 CAT 的角度來看，是確實患有晚期疾病的患者，這種疾病已經對器官（特別是腎臟等器官）產生影響，因此這些患者確實存在結構性損傷。現在，當我們考慮治療的影響時，確實存在這種情況。顯然，我們希望這種療法能夠對發炎過程和發炎參數以及我們在這些疾病中看到的許多表現產生直接影響，我將在下一張幻燈片中討論這些患者所患的各種類型的疾病。

And you also would expect that gradually either have a stabilization of the underlying organ that's impacted and if it is early enough in the progression of the disease, an ability to actually reverse the negative outcome on that on that organ. So at least stabilize and the oxide, improve the organ function. So, with that as sort of a sort of a backdrop, what I'd like to do is really talk now briefly about the outcome that we have presented at the R&D event from our phase one CARSLYLE study in patients with systemic lupus [erythematosus].

而且你還會期望受影響的潛在器官逐漸穩定下來，如果疾病進展得夠早，則能夠真正扭轉該器官的負面結果。因此至少可以穩定氧化物，改善器官功能。因此，基於這樣的背景，我想簡單談談我們在研發活動上展示的針對系統性紅斑狼瘡患者進行的第一階段 CARSLYLE 研究的結果[紅斑狼瘡]。

So, when we look at our patient groups that we have, and this is now on slide number nine, when we look at our patients, we do see that these patients actually are quite more advanced compared to the patients that were treated at the University of Erlangen by Georg Schett's team. These patients are older, they're-- 19 years to 50 years of age, and they also had quite long disease histories. So, the disease history of these patients was at least 3 years up to 23 years.

因此，當我們查看我們的患者群體時，這是第九張幻燈片，當我們查看我們的患者時，我們確實發現這些患者的病情實際上比埃爾蘭根大學 Georg Schett 團隊治療的患者病情要嚴重得多。這些患者年齡較大，年齡在 19 歲至 50 歲之間，且患病史也相當長。因此，這些患者的病史至少為3年，最長為23年。

So these are patients that have been battling with that with the disease for a long period of time. And when you look at the SEI scores, which are disease scores in these patients, you see them range from 16 to 28. So this is a very severe population and in fact all of those all of those patients had kidney involvement. So, all of them actually had already signs of kidney damage when we looked at these patients closely. So, when we look at the patients, we do see that 5 or 6 of these, 5 or 6 patients had class 4 disease, and 4 of the 6 also had class 5 components.

這些患者已經與疾病鬥爭了很長一段時間。當您查看 SEI 評分（這些患者的疾病評分）時，您會發現它們的範圍從 16 到 28。所以這是一個非常嚴重的人群，事實上所有這些患者的腎臟都受到了影響。因此，當我們仔細觀察這些患者時，他們實際上都已經出現了腎臟受損的跡象。因此，當我們觀察這些患者時，我們確實發現其中有 5 或 6 名患者患有 4 類疾病，而這 6 名患者中有 4 名還患有 5 類疾病。

And these are patients that have gone through the standard of care have also already gone through the Challenges with regards to B cell depleting agents as well as calcium EUR inhibitors and what we're seeing is that in many of these patients, 4 out of 6, we already had significantly impaired kidney function. Now when we look at the overall adverse event profile in these patients, we do see that the patients obviously had quite a lot of impact related to kidney damage, leading to hypertension, etc.

這些患者在接受標準治療的同時，也經歷了 B 細胞耗竭劑以及鈣 EUR 抑制劑的挑戰，我們發現，在這些患者中，每 6 名患者中就有 4 名患者的腎功能已經嚴重受損。現在，當我們查看這些患者的整體不良事件概況時，我們確實發現患者明顯受到了與腎臟損害相關的相當大的影響，從而導致高血壓等。

But when we look at the immunological toxicity, we do see that the CRS that we're observing in these patients is that 3 patients out of the 6 patients have observed Grade one cytokine release syndrome, but none of the patients has experienced neurological toxicity or eyes. This is relevant because every approach that was tested, CAR T approach that was tested outside of the experience at the University of Erlangen in patients with lupus nephritis have reported ICANS in their small data sets.

但是，當我們觀察免疫毒性時，我們確實發現我們在這些患者中觀察到的 CRS 是，6 名患者中有 3 名患者觀察到一級細胞因子釋放綜合徵，但沒有一名患者出現神經毒性或眼睛毒性。這很有意義，因為在埃爾朗根大學對狼瘡性腎炎患者的經驗之外測試的每種方法、CAR T 方法都在他們的小數據集中報告了 ICANS。

So, with that, moving to the next slide, this is slide number 10, and we're now talking looking at the individual profile that we're seeing in the patients based on the SLEDAI-2K scores. So, the SLEDAI scores are scores that actually look at a composite of parameters related to the function of organs, antibodies, autoantibodies in these patients, complement, but also looking at the experience related to other forms of the inflammatory diseases that these patients may see.

那麼，請繼續看下一張投影片，這是第 10 張投影片，我們現在討論的是根據 SLEDAI-2K 評分來查看患者的個人資料。因此，SLEDAI 評分實際上是檢視與這些患者的器官功能、抗體、自體抗體、補體相關的參數的綜合，同時也檢視這些患者可能遇到的其他形式的發炎疾病的相關經歷。

Now, I'll focus first on patient number one. Now what you can see is this patient had a SLEDAI score of 28 at the start, and in addition to obviously having very significantly impaired kidney function and obviously double strand DNA antibodies and low levels of complement, the patient actually had other manifestations of disease including rash, arthritis, and alopecia. Now, when you think about what are those, which ones of those types of parameters the patient actually can experience, those are in fact rash, arthritis, and alopecia. The lab parameters you can't sense and the kidney function you can't really sense either. So, the primary experience of the disease is around those inflammatory processes.

現在，我先專注在第一位病人。現在您可以看到，該患者開始時的 SLEDAI 評分為 28，除了明顯腎功能受損、明顯的雙股 DNA 抗體和低水平補體外，患者實際上還有其他疾病表現，包括皮疹、關節炎和脫髮。現在，當您思考這些是什麼時，患者實際上會經歷哪些類型的參數，這些參數實際上是皮疹、關節炎和脫髮。您無法感知實驗室參數，也無法真正感知腎臟功能。因此，該疾病的主要表現是圍繞著發炎過程。

What you can see is that very quickly, within a short period of time, all of these symptoms in these with these additional inflammatory processes actually have been removed, and there you see then a gradual improvement also on the kidney side. When you then look at the other patients, you see combinations of those various forms of manifestations of inflammation. But you also see that all of these patients improve on the top line. We have three months of follow up at least, and on the bottom line, we have only one-month of follow up. So, with that, What I think it is important to realize is that although this is a limited amount of time in terms of the follow up, we had very quick improvements on those inflammatory processes, and we also started to already see that 3 patients of the 6 patients did actually achieve renal complete remission.

您可以看到，在很短的時間內，所有這些症狀以及這些額外的發炎過程實際上都已消除，腎臟方面也逐漸得到改善。當你觀察其他患者時，你會看到各種形式的發炎表現的組合。但你也會發現所有這些患者的治療效果都有改善。我們至少有三個月的跟進，但最終我們只有一個月的跟進。因此，我認為重要的是要認識到，儘管就後續治療而言這是一段有限的時間，但我們對這些發炎過程的改善非常快，並且我們也已經開始看到 6 名患者中有 3 名確實實現了腎臟完全緩解。

And that is obviously very meaningful in this population, and we expect those patients to sort of continue to improve over time. So very strong start gives us a very strong set of indication in terms of the ability of the therapy of the therapy to actually improve the outcomes for these patients, obviously combined with a very good safety profile. When we look at the properties of the product, the properties actually are very consistent with what we have observed in the oncology setting. We see comparable level of peak expansion.

這對這個群體來說顯然非常有意義，我們預計這些患者的病情會隨著時間的推移而不斷好轉。因此，非常強勁的開端為我們提供了非常強有力的跡象，表明該療法確實能夠改善這些患者的治療結果，而且顯然還具有非常好的安全性。當我們觀察該產品的屬性時，我們發現其屬性實際上與我們在腫瘤學環境中觀察到的非常一致。我們看到了相當的峰值擴張。

What we do see is shorter persistence, so the persistency here is about 3 months, maybe for a few patients a little bit longer. And when you see loss of persistence, you also do see B cells coming back, and the B cells that are coming back are predominantly naive B cells as you would expect. But then over time for those patients where we have that data at this point start to differentiate into more differentiated forms of B cells as we would have postulated.

我們確實看到的是較短的持久性，所以這裡的持久性大約是 3 個月，對於少數患者來說可能更長一些。當你看到持久性喪失時，你也會看到 B 細胞回來了，而且回來的 B 細胞主要是幼稚 B 細胞，正如你所預料的那樣。但隨著時間的推移，對於那些我們目前擁有該數據的患者，細胞開始分化為更具分化形式的 B 細胞，正如我們所假設的那樣。

So, with that we're going to move to slide number 11. Slide number 11 actually looks at the opportunity that we have in lupus in general with a particular focus on lupus nephritis. What we're looking to do here is really focus on the patient population with the highest medical need, which are the patients that are refractory to standard of care in the lupus nephritis group of patients. And that's around 25,000 patients to 35,000 patients or about give or take 10% of the overall SLE population in the US. The reason why we're focusing on lupus nephritis is on the one hand the medical need, but on the other hand, it is the importance of having an objective end point that you can follow.

因此，我們將轉到第 11 張投影片。第 11 張投影片實際上展示了我們在治療狼瘡方面所面臨的整體機遇，特別是狼瘡性腎炎。我們在這裡要做的實際上是關注醫療需求最高的患者群體，即對狼瘡性腎炎患者組中的標準治療有抵抗力的患者。這意味著大約有 25,000 到 35,000 名患者，或占美國 SLE 總人口的 10% 左右。我們關注狼瘡性腎炎的原因一方面是醫療需求，另一方面是擁有一個可以遵循的客觀終點的重要性。

We just looked on the slide before on SLEDAI scores, and you could see the complexity of the scores. What you haven't seen is that some of those scores are actually based on either physician assessment or patient assessment. So, in other words, there is an element that actually is a much softer type of data that goes into these scores relevant to describe the disease, but much harder to actually think about statistical outcomes and be able to actually get to relevant data in a smaller data set. Going after lupus nephritis allows you to look at renal complete remissions and with that have a very clear endpoint that it can actually follow.

我們剛剛看了有關 SLEDAI 評分的幻燈片，您可以看到評分的複雜性。您還沒有看到的是，其中一些分數實際上是基於醫生評估或患者評估。換句話說，這些與描述疾病相關的分數中實際上包含一種更為軟性的數據類型，但實際上很難思考統計結果，也很難在較小的數據集中真正獲得相關數據。透過對狼瘡性腎炎的追踪，您可以觀察腎臟的完全緩解情況，從而獲得可以實際追蹤的非常明確的終點。

Now moving to slide number 12. What we see in flight number 12 is basically the trajectory that we're planning for our development in lupus nephritis. What we're doing with our current study with the CARSLYLE study, is actually establish a fixed dose for adult and adolescent patients. With that fixed dose, remember these were SLE patients with kidney manifestation. In fact, they're all categorized as lupus nephritis patients.

現在轉到第 12 張投影片。我們在第 12 次航班上看到的基本上是我們為狼瘡性腎炎發展規劃的軌跡。我們目前正在進行的 CARSLYLE 研究實際上是為成人和青少年患者制定固定劑量。透過固定劑量，請記住這些是患有腎臟表現的 SLE 患者。事實上，他們都屬於狼瘡性腎炎患者。

Those patients actually when we look at them, are the right kind of backdrop that we would also expect to include into the single arm phase two study that it's as a pivotal character. This particular, population is our patients that also have been already exposed to B cell depleting agents. So, these are typically antibody-based therapies. As well as a calcium neuron inhibitor and are past those two therapies, so it's a proper refractory lupus nephritis population.

實際上，當我們觀察這些患者時，他們就是正確的背景，我們也希望將他們納入單臂第二階段研究中，作為關鍵人物。這個特殊的族群是我們的患者，他們也已經接觸過 B 細胞耗竭劑。所以，這些通常是基於抗體的療法。以及鈣神經元抑制劑，並且已經超越了這兩種療法，因此它是一種適當的難治性狼瘡性腎炎族群。

So, the approach here is to have a compact opportunity for a compact study with an objective endpoint and with that have an ability to be forced to market in this indication with a CD19 CAR T product. We're then actually envisaging that from there on forward there is an opportunity to consider moving into a somewhat earlier stage of disease where we're going to look at a comparative or randomized trial against standard of care, but clearly the core of the approach is a fast to market strategy based on the refractory population with an objective input.

因此，這裡的方法是有一個緊湊的機會進行具有客觀終點的緊湊研究，並有能力使用 CD19 CAR T 產品強制推向市場。然後，我們實際上設想，從那時起，就有機會考慮進入疾病的早期階段，我們將研究針對治療標準的比較或隨機試驗，但顯然該方法的核心是基於難治性人群的快速上市策略，並提供客觀的輸入。

So, this study obviously is already getting started. We have gone through the regulatory process in the in the US and interacted with the FDA on the design of the product and also have an open ID for lupus nephritis. And we're in the process of going through the regulatory steps in other jurisdictions that we're planning to include in this clinical trial.

因此，這項研究顯然已經開始了。我們已經完成了美國的監管流程，並就產品設計與 FDA 進行了互動，並且還擁有針對狼瘡性腎炎的開放 ID。我們正在審查其他司法管轄區的監管步驟，並計劃將其納入此次臨床試驗。

With that, we're moving to slide number 13 and going to look at one of the opportunities we're very excited about, which is the opportunity in progressive multiple sclerosis. Now this is the part of the disease that really has the highest medical need. It's about 30% of the relapse remitting of the total population. You have relapse remitting about 700,000 patients, and you have progressive MS in about 300,000 patients. That is where we're planning to go. These are patients that have gone through standard of care and progressed despite exposure to standard of care for at least 6 months.

接下來，我們轉到第 13 張投影片，討論讓我們非常興奮的一個機會，即治療進行性多發性硬化症的機會。現在，這是該疾病中真正最需要醫療的部分。約佔總人口復發率的30%。約有 70 萬名患者為復發緩解型 MS，約有 30 萬名患者為進行性 MS。那就是我們計劃去的地方。這些患者已經接受了標準治療，儘管接受了至少 6 個月的標準治療，但病情仍然有所改善。

Now when we think about MS, it's a disease that we know has a significant B cell component. They're obviously a disease where CD20 targeting monoclonal antibodies are effective. However, the disease itself obviously is driven not just by T cells that are in the periphery and are reachable with a soluble agent that you infuse into the blood. But there are also B cells that sit on the other side of the blocked brain barrier in the brain itself, and obviously those cells are not reachable for conventional therapeutic approaches that are based on either on proteins, T cell engagers, etc.

現在，當我們想到 MS 時，我們知道它是一種具有重要 B 細胞成分的疾病。顯然，這是一種針對 CD20 的單株抗體有效的疾病。然而，這種疾病本身顯然不僅僅是由位於周圍的 T 細胞引起的，而且可以透過注入血液的可溶解劑到達。但是，在大腦本身中，還有位於阻塞腦屏障另一側的 B 細胞，顯然，這些細胞無法透過基於蛋白質、T 細胞接合劑等的傳統治療方法到達。

Now what we do know about obe-cel is that obe-cel actually works very well across the blocked brain barrier, and we have explored that in primary CNS lymphoma and in collaboration with our colleagues at UCL and could show that indeed the product had an ability when given. Systemically, so infused into the bloodstream, had an ability to cross the blood brain barrier and actually lead to tumor reductions in the brain, and that obviously is what exactly the type of activity you would need in these patients.

現在我們對 obe-cel 的了解是，obe-cel 實際上可以在阻塞的腦屏障上發揮很好的作用，我們已經在原發性中樞神經系統淋巴瘤中探索了這一點，並與倫敦大學學院的同事合作，證明了該產品在給藥時確實具有功效。系統性地註入血液後，能夠穿過血腦屏障，實際上導致腦內腫瘤減少，這顯然正是這些患者所需的活動類型。

So, getting at those B cells, malignant B cells or B cells that are sitting behind the blood brain barrier is at the core of what we're looking to do. We believe obe-cel is exceptionally well positioned to actually have that type of an activity. So, when we look at the approach that we're taking here is we're starting off a study in progressive MS, and in fact those are patients where we're going to run through a dose escalation. We know in the CNS lymphoma that 200 million cell dose was the cell dose that was active. And gave us a proper activity in the brain, but we're going to run through a dose escalation here, obviously higher levels of doses than the 50 million cell dose that we have used so far in the SLE patients.

因此，找到那些 B 細胞、惡性 B 細胞或位於血腦障壁後面的 B 細胞是我們要做的核心工作。我們相信 obe-cel 擁有極佳的條件來進行此類活動。因此，當我們考慮我們在此採取的方法時，我們正在開始一項針對進行性 MS 的研究，事實上，對於這些患者，我們將進行劑量遞增。我們知道，在中樞神經系統淋巴瘤中，2 億個細胞劑量是活躍的細胞劑量。並讓我們的大腦產生適當的活動，但在這裡我們將進行劑量遞增，顯然劑量要高於我們迄今為止在 SLE 患者中使用的 5000 萬個細胞劑量。

We're going to look at a range of biomarkers as well as imaging, and we're going to follow these patients to understand the clinical impact that we and outcomes that we can see in these patients and to see whether we can see an impact on the clinical disability progression of these patients. With positive data, we obviously would then move in the randomized phase 23 study to drive towards a registration for this type of an indication. Very exciting program, and we're looking forward to updating you, as we're making progress in this.

我們將研究一系列生物標記和影像技術，並追蹤這些患者，以了解我們在這些患者身上看到的臨床影響和結果，看看我們是否可以看到對這些患者臨床殘疾進展的影響。有了積極的數據，我們顯然會進入隨機第 23 期研究，以推動此類適應症的註冊。非常令人興奮的計劃，我們期待向您更新進展，因為我們在這方面取得了進展。

So with that, I would like to hand over to Rob who will walk us through the financial results.

因此，我想將時間交給 Rob，他將向我們介紹財務結果。

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the first quarter of 2025, and I'll be referring to slide 16 in the presentation.

謝謝，克里斯蒂安，大家早安或下午好。我很高興回顧我們 2025 年第一季的財務業績，我將參考簡報中的第 16 張投影片。

For our first quarter of product sales, net product revenue for the three months ended March 31, 2025. Was $9 million. We're off to a strong start with the US launch of AUCATZYL. As Christian noted, as well as, included in the press release, earlier today, on April 1, CMS included AUCATZYL in their published coding determinations and outpatient payment rates, formalizing reimbursement for patients on government programs.

我們第一季的產品銷售額，即截至 2025 年 3 月 31 日的三個月的淨產品收入。為900萬美元。隨著 AUCATZYL 在美國的推出，我們取得了良好的開端。正如克里斯蒂安在今天早些時候的新聞稿中指出的那樣，4 月 1 日，CMS 將 AUCATZYL 納入了其已發布的編碼確定和門診支付率中，正式確定了政府項目患者的報銷。

The CMS Hospital Outpatient prospective Payment System or OPTS splits the therapeutic dose of AUCATZYL into two administrations for coding and billing purposes. As a result, we are working with our treatment centers on implementing the coding and payment policy from CMS. As well, we are internally assessing any potential impact on the timing of our revenue recognition moving forward.

CMS 醫院門診預付費系統 (OPTS) 將 AUCATZYL 的治療劑量分為兩次給藥，以便進行編碼和計費。因此，我們正在與我們的治療中心合作實施 CMS 的編碼和付款政策。此外，我們正在內部評估對我們未來收入確認時間的任何潛在影響。

Moving on to cost of sales in the first quarter of 2025, cost of sales totaled $18 million. This amount includes the cost of all commercial product delivered to the authorized treatment centers, including product delivered but yet not yet administered to patients. So, it's worth noting here that the sales value of these products is not yet recorded as product revenue in the P&L but is reflected as deferred revenue on the balance sheet.

2025 年第一季的銷售成本總計 1,800 萬美元。該金額包括運送至授權治療中心的所有商業產品的成本，包括已運送但尚未給患者使用的產品。因此，值得注意的是，這些產品的銷售價值尚未在損益表中記錄為產品收入，而是在資產負債表上反映為遞延收入。

Additionally, cost of sales includes any canceled orders in the period, patient access program, product, and third-party royalties for certain technology license. Our research and development expenses decreased to $26.7 million for the three months ending March 31, 2025 compared to $30.7 million during the same period in 2024. This change was primarily driven by commercial manufacturing related employee and infrastructure cost shifting from R&D to cost of sales and inventory following the approval of a capsule and the associated accounting change that occurs at that time.

此外，銷售成本包括期間內取消的任何訂單、患者存取計劃、產品以及某些技術許可的第三方特許權使用費。截至 2025 年 3 月 31 日的三個月，我們的研發費用下降至 2,670 萬美元，而 2024 年同期為 3,070 萬美元。這項變更主要是由於商業製造相關的員工和基礎設施成本在膠囊獲得批准以及當時發生的相關會計變更後從研發轉移到銷售和庫存成本。

This was partially offset by an increase in obe-cel clinical trial activity and supply costs. Our selling general and administrative expenses increased to $29.5 million for the three months ended March 31st, 2025, compared to $18.2 million in the same period in 2024. This increase was primarily due to salaries and other employee related costs driven by increased headcount supporting US commercialization activities associated with the launch of a capsule.

這部分被 obe-cel 臨床試驗活動和供應成本的增加所抵消。截至 2025 年 3 月 31 日的三個月，我們的銷售一般及行政費用增加至 2,950 萬美元，而 2024 年同期為 1,820 萬美元。這一增長主要是由於支持與太空艙發射相關的美國商業化活動的員工人數增加而導致的工資和其他員工相關成本。

Our loss from operations for the three months ended March 30, 2025, with $65.2 million as compared to $38.8 million for the same period in 2024. And finally, net loss was $70.2 million for the three months ending March 31, 2025, compared to $52.7 million for the same period in '24. Our cash equivalents and marketable securities at the end of Q1 2025 totaled $516.6 million as compared to $588 million at the end of December 2024. The decrease was primarily driven by net cash used in operating and investing activities, but also impacted by a delayed cash receipt of approximately $20 million in R&D tax credit that we expect from the UK HMRC.

截至 2025 年 3 月 30 日的三個月，我們的營業虧損為 6,520 萬美元，而 2024 年同期為 3,880 萬美元。最後，截至 2025 年 3 月 31 日的三個月的淨虧損為 7,020 萬美元，而 24 年同期的淨虧損為 5,270 萬美元。截至 2025 年第一季末，我們的現金等價物及有價證券總額為 5.166 億美元，而 2024 年 12 月底為 5.88 億美元。下降的主要原因是經營和投資活動中使用的淨現金，但也受到我們預計將從英國稅務海關總署獲得的約 2000 萬美元研發稅收抵免的延遲現金收到的影響。

We continue to believe that with our current cash equivalents and marketable securities, we are well capitalized to drive the launch and commercialization of obe-cel in relapsed refractory B-ALL and to obtain data in the loop lupus nephritis pivotal trial and MS phase 1 trials that Christian just talked about.

我們仍然相信，憑藉我們目前的現金等價物和有價證券，我們有足夠的資金來推動 obe-cel 在復發難治性 B-ALL 中的推出和商業化，並獲取 Christian 剛才談到的狼瘡性腎炎關鍵試驗和 MS 1 期試驗的數據。

I'll now hand back to Christian to wrap up with a brief outlook on expected milestones, Christian.

現在我將把發言權交還給克里斯蒂安，讓他對預期的里程碑做一個簡短的展望。

Thanks, Rob. Moving to slide 18, first off, in terms of the activities that we're expecting on the EU side, first off, we're excited, obviously to update you on the longer term follow up from the FELIX study, which we expect to be able to do towards the end of the second quarter. We also expect that for the second half of the year, the notification from the EU regarding the market authorization application decision for the patients with relapsed refractory adult B-ALL, and we are planning towards the end of the year to present initial data from our pediatric study PY01.

謝謝，羅布。轉到投影片 18，首先，就我們預期歐盟方面開展的活動而言，首先，我們很高興向您通報 FELIX 研究的長期後續情況，我們預計能夠在第二季末完成這項工作。我們也預計，今年下半年將收到歐盟關於復發難治性成人 B-ALL 患者的市場授權申請決定的通知，並且我們計劃在今年年底前展示我們兒科研究 PY01 的初步數據。

When we look at the autoimmune side, we're planning for an update and data presentation for the CARSLYLE study in the fourth quarter. We also expect to be reporting first patient dose for the phase 2 lupus nephritis study, as well as having the first patient dosed for the progressive MS phase 1 study in towards the second half and actually towards the end of 2025. And then finally we're also are moving forward with our program Auto Aid, the dual targeting CD19 BCMA approach where we're evaluating that product in light chain amyloidosis in a phase one trial together with our collaborators at University College in London.

當我們研究自體免疫方面時，我們計劃在第四季度對 CARSLYLE 研究進行更新和數據展示。我們也預計在 2025 年下半年，也就是 2025 年底，報告狼瘡性腎炎 2 期研究的首位病患劑量，以及進行性 MS 1 期研究的首位病患劑量。最後，我們還將推進我們的 Auto Aid 項目，即雙重靶向 CD19 BCMA 方法，我們正在與倫敦大學學院的合作夥伴一起在第一階段試驗中評估該產品在輕鏈澱粉樣變性中的作用。

With that, I get to slide number 19, which is a summary from what we covered today. First of all, we believe that all is well positioned for value creation, and we're building on a very strong foundation with obe-cel. Obviously, we talked about the capsule launch in the US. We had a strong first quarter. We're building towards 60 centers which give us the vast majority of patients access in the US.

這樣，我就看到了第 19 張投影片，這是我們今天所講內容的摘要。首先，我們相信一切都已為價值創造做好了準備，並且我們正在透過 obe-cel 奠定非常堅實的基礎。顯然，我們討論了在美國推出膠囊的問題。我們第一季表現強勁。我們正在建造 60 個中心，以便為美國絕大多數患者提供治療服務。

We obviously are established infrastructure for manufacturing. You remember the nucleus that's, shown in the picture on the right-hand side, as well as obviously our commercial infrastructure, which is executing very well. And we're starting to move into other jurisdictions with the MHR authorization that we have received and we're preparing for launch in the UK and we're also gearing up for our for the activities in Europe with an expected decision from the EU in the second half of the year.

我們顯然已經建立了製造業基礎設施。您還記得右側圖片中顯示的核心，以及顯然運作良好的商業基礎設施。我們已獲得 MHR 授權，並開始進軍其他司法管轄區，準備在英國推出該業務，同時我們也在為歐洲的活動做準備，預計歐盟將在下半年做出決定。

When we look at obe-cel in terms of the opportunity beyond the initial opportunity in adult B-ALL, we obviously are building on the unique mode of action with a fast off rate CD19 T, which gives us a very high level of activity as well as a very well manageable tolerable profile for the product.

當我們從成人 B 細胞急性淋巴細胞白血病 (B-ALL) 的初始機會之外的角度來看待 obe-cel 時，我們顯然正在利用快速解離速率 CD19 T 的獨特作用模式進行構建，這為我們提供了非常高的活性水平以及非常易於管理的產品耐受性。

Remember, the product was the first one, the CD19 CAR T product that was approved without a REMS obligation, and as indicated, we're having long term follow up data coming relatively shortly and then data sets from the PY01 study and the CARSLYLE study towards the end of the year. All of this is built on a strong cash position of $516 million at the end of Q1, and I think sets us up very well from an execution perspective.

請記住，該產品是第一個獲得批准且無需 REMS 義務的產品，並且如圖所示，我們將很快獲得長期追蹤數據，然後在年底獲得 PY01 研究和 CARSLYLE 研究的數據集。所有這些都建立在第一季末 5.16 億美元的強勁現金狀況之上，我認為從執行的角度來看，這為我們做好了充分的準備。

So, with that, I think we've reached the end of the presentation and we'd like to open up for questions.

因此，我想我們的演示已經結束了，我們想開始回答問題。

Thank you. (Conference Instructions)

謝謝。（會議指示）

Your first question comes from the line of James Shin from Deutsche Bank.

您的第一個問題來自德意志銀行的 James Shin。

Hey, good morning, guys.

嘿，大家早安。

Thank you for taking my question. I have a couple.

感謝您回答我的問題。我有一對。

Firstly, I guess for the April 1st coding update for capsule and the $18 million of COGS and those associated deferred revenues, can you say whether the $9 million of revenue recognition for Q125 was triggered upon initial dosing, or is revenue recognized only upon patients receiving their full split dose? And then going forward it sounds like there may be some impact from the April 1st coding update.

首先，我猜對於 4 月 1 日膠囊的編碼更新和 1800 萬美元的 COGS 以及相關的遞延收入，您能否說一下 Q125 的 900 萬美元收入確認是在首次給藥時觸發的，還是僅在患者接受全劑量分劑量時才確認收入？然後展望未來，聽起來 4 月 1 日的編碼更新可能會產生一些影響。

And I have follow-ups.

我還有後續行動。

All right, James, first of all, thanks for joining. Before we actually, Rob will walk you through the rev re answer in detail. I think just to get started, all patients that we had in Q1 received both doses, so it didn't matter from a practical perspective, but I'll have Rob talk you through the rev re approach that we're taking, Rob.

好的，詹姆斯，首先感謝您的加入。在我們真正開始之前，Rob 將向您詳細介紹 rev re 答案。我認為首先，我們在第一季度的所有患者都接受了兩劑治療，所以從實際角度來看這並不重要，但我會讓 Rob 向您介紹我們正在採取的 rev re 方法，Rob。

Yeah, hi James, thanks for the question. So, let's start maybe with the current guidance and approach that we had discussed previously was in fact kind of that full recognition with confirmation on the first administration and that is what's reflected in Q1. As Christian said, we've confirmed that all those patients in fact have received both the first and second dose as well, but we were really following the policy that we've kind of discussed before.

是的，嗨，詹姆斯，謝謝你的提問。因此，讓我們從之前討論過的當前指導和方法開始，這實際上是對第一屆政府的充分認可和確認，而這正是 Q1 所反映的。正如克里斯蒂安所說，我們已經確認所有這些患者實際上都接種了第一劑和第二劑，但我們確實遵循了之前討論過的政策。

As noted, CMS published and this is effective April 1, on the OPPS side, so this is for outpatients, a split coding and billing into two administrations. So as I noted, we're working with the centers to adjust things on their end. We are evaluating the implications on our own revenue recognition policy as well. So unfortunately we don't have a final answer here, but I think it might be important maybe to put a few data points here and put it into some perspective.

如上所述，CMS 已發布該規定，該規定於 4 月 1 日在 OPPS 方面生效，因此這是針對門診病人的，將編碼和計費分為兩個管理部門。正如我所說，我們正在與各中心合作，調整他們的工作。我們也在評估這對我們自己的收入確認政策的影響。所以不幸的是我們還沒有最終答案，但我認為在這裡放一些數據點並將其放在某個角度來看可能是很重要的。

When we look at the experience that we have in particular in the Felix study with respect to patients that completed or didn't complete both administrations, 5.5% of the patients did not receive the second dose. Right, and that's before considering any inpatient, outpatient setting in the commercial space, but so from a total number perspective, it's a smaller portion of the overall patient population. These also tended to be much more severe patients with median tumor burden at 80% or more.

當我們回顧 Felix 研究中針對完成或未完成兩次給藥的患者的經驗時，我們發現 5.5％ 的患者沒有接受第二劑。是的，這還沒有考慮商業空間中的任何住院、門診情況，但從總數的角度來看，它只佔整體患者群體的一小部分。這些患者的病情往往更為嚴重，平均腫瘤負荷為 80% 或更高。

The next piece is to think about the timing corridor that we have here. And so, if you look at the timing corridor between first and second administration currently in the USPI it's 10 days plus or minus 2 days. And from a commercial experience year-to-date it's early but that average has been about 9 days and so given the number of patients that we're talking about here and certainly the timing between the first and second administration while we're still evaluating the overall implications for kind of technical revenue recognition, we don't expect it to have a material impact on the full year sales.

下一步是考慮我們這裡的時間走廊。因此，如果您查看 USPI 中目前第一次和第二次管理之間的時間間隔，則為 10 天加減 2 天。從今年迄今為止的商業經驗來看，現在還為時過早，但平均時間約為 9 天，因此考慮到我們在此討論的患者數量，當然還有第一次和第二次給藥之間的時間，而我們仍在評估對技術收入確認的總體影響，我們預計它不會對全年銷售產生重大影響。

So hopefully that helps on that question.

希望這對這個問題有所幫助。

Thank you, Rob.

謝謝你，羅布。

Secondly, I guess, Christian, I have one on tariffs. I totally understand CAR T products were spared from the initial retaliatory tariffs via Annex two, and I guess coincidentally, I believe 10 o'clock today, President Trump is expected to announce a tariff agreement with the UK. We're also expecting pharmas specific tariffs maybe over the next week or so. I guess long-winded way of asking any early color on O CAT's potential exposure to UK or pharma-specific tariffs.

其次，克里斯蒂安，我想問關於關稅的問題。我完全理解 CAR-T 產品透過附件二免受最初的報復性關稅，而且我猜巧的是，我相信今天 10 點，川普總統預計將宣布與英國達成關稅協議。我們也預計未來一周左右可能會推出針對製藥業的具體關稅。我想，這是在冗長地詢問有關 O CAT 可能受到英國或製藥特定關稅影響的任何早期細節。

First of all, I understand the question. I think we're operating on about as much information as you do.

首先，我理解這個問題。我認為我們所掌握的資訊和你們一樣多。

I think the bottom line is that maybe a few points here. First of all, there's a good reason why blood products tend to be exempt from tariffs because literally it's a single individual patient cells that you're actually going to tarry, so you're going to tariff the US and Americans patients' cells before that patient can receive the therapy. So that thing of itself is an interesting thing to think about.

我認為底線可能是這裡有幾個要點。首先，血液製品往往免關稅是有原因的，因為實際上你要保留的是一個病人的細胞，所以在病人接受治療之前，你要對美國和美國病人的細胞徵收關稅。所以這件事本身就是一件值得思考的有趣的事。

So, there's a good reason why typically those were excluded. We don't know where the administration comes out on this. We also don't know yet, obviously what the deal is between the UK and the US at this point in time. What is worthwhile to remember though is that when you think about tariffs, what is relevant in terms of the value that's sort of used to actually calculate the tariffs from.

因此，通常將這些排除在外是有充分理由的。我們不知道政府對此有何看法。顯然，我們還不知道目前英國和美國之間的協議是什麼。然而值得記住的是，當你考慮關稅時，與實際用於計算關稅的價值相關的是什麼。

It is not the price of a product as the product is sold, but it is the customs value which is typically linked to the manufacturing of the product itself and the manufacturing related costs of the product, and then it has, a few additional finer points to it, but basically that's kind of at the core of it. So it is a limited amount. It's not the full amount that then actually would be the basis for the calculation of the tariff. We need to see where we end up there was initially talk of a 10% tariff corridor for the UK, we'll all know more in probably about 45 minutes from now.

它不是產品銷售時的價格，而是海關價值，通常與產品本身的製造以及產品製造相關成本有關，然後它還有一些額外的細節，但基本上這就是它的核心。所以數量是有限的。實際上，計算關稅的依據並不是全部金額。我們需要看看最終結果如何，最初談論的是英國的 10% 關稅走廊，大約 45 分鐘後我們就會知道更多。

Great. And then finally, and this is quite fresh, any chance Doctor Venna Prasad taking the reins of Siber may result in the FDA revisiting any already agreed upon pivotal trial designs such as the phase two you have for lupus?

偉大的。最後，這是個新鮮事，如果 Venna Prasad 醫師接手 Siber，FDA 是否可能會重新審視任何已經達成一致的關鍵試驗設計，例如針對狼瘡的第二階段試驗？

I mean, we don't know at this point in time kind of how the, what's the impact on the FDA going forward of any off front to denominations and the changes that are in the works. Obviously, we had a full conversation with the FDA on the trial design, the patient population, the description of the patients, etc. So, there was this is not a sort of a loose sort of conversation. It's a very detailed conversation on the approach.

我的意思是，我們目前還不知道正在進行的任何教派變革對 FDA 未來有何影響。顯然，我們就試驗設計、患者群體、患者描述等問題與 FDA 進行了充分的對話。所以，這不是一種鬆散的對話。這是關於該方法的非常詳細的對話。

So that said, we don't know whether it's going to be what changes might look like. I think in general there's been sort of, two kind of areas that I think we've seen. One is I think a clear statement from the administration to look to accelerate access and also to accelerate the approval processes. So that's one dimension that we're hearing. And then there's obviously various degrees and views on the individual measures and approaches that could be considered here.

話雖如此，我們不知道它到底會是什麼樣的改變。我認為總體而言，我們已經看到了兩個領域。一是我認為政府明確表示要加快准入速度並加快審批流程。這是我們聽到的一個面向。顯然，對於這裡可以考慮的個別措施和方法，存在著不同程度和觀點。

I think we'll need to wait and see. I don't think there's a good answer for this at this point in time. Obviously from where we are at this point with regards to the product, I think the trial will give us a very clear answer on the on the utility of the product in this setting. These are very severe patients. These are not patients that are. Where you have actually other options that give them a good outlook. And I think medical need will matter and will continue to matter going forward in those assessments.

我認為我們需要拭目以待。我認為目前對此還沒有好的答案。顯然，從我們目前對產品的了解來看，我認為這次試驗將給我們一個非常明確的答案，關於該產品在這種環境下的實用性。這些都是病情非常嚴重的患者。這些並不是病人。實際上，您還有其他選擇可以為他們帶來良好的前景。我認為醫療需求很重要，並且在這些評估中仍將很重要。

Thank you so much, Christian. I'll yield to the floor.

非常感謝，克里斯蒂安。我將屈服於發言權。

Thank you.

謝謝。

Thank you.

謝謝。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Matthew Phipps from William Blair.

我們的下一個問題來自威廉布萊爾的馬修菲普斯。

Thanks for taking my questions. Congrats on nice start out of the gate. Rob, could you give us any more breakdown of the COGS in the quarter as far as just maybe how much came from canceled orders or patient access programs? And then, going back to some of the data from the R&D day, I know, not a ton of patients.

感謝您回答我的問題。恭喜您有一個好的開始。羅布，您能否向我們提供本季度銷貨成本的更多明細，其中可能有多少來自取消的訂單或患者訪問計劃？然後，回顧研發日的一些數據，我知道，病人數量不多。

But it does look like you're seeing greater persistence of obe-cel. Than what others have seen in the autoimmune disease settings. I know that it's kind of consistent with maybe what you guys have obviously shown in in adult B-ALL and other hematology indications. But do you think that's a differentiator in autoimmune disease or, doesn't matter in terms of driving that kind of reset?

但看起來你確實看到了 obe-cel 更強的持久性。比其他人所見的自體免疫疾病更甚。我知道這可能與你們在成人 B-ALL 和其他血液學指徵中所明確展示的情況一致。但是，您是否認為這是自體免疫疾病的區別因素，或者，對於推動這種重置並不重要？

Okay.

好的。

Rob, do you want to go first? Yeah.

羅布，你想先走嗎？是的。

I'll start on the cost of goods. Thanks for your question, Matt. Maybe stepping back a little bit just to clarify in terms of, overall high level, what's going through cost of sales obviously contains the cost of the product manufactured also includes things like third party royalty license and some other period expenses, distribution fees, for example, it kind of flow through there.

我先從商品成本開始說起。謝謝你的提問，馬特。也許我們稍微退一步來澄清一下，從總體高層次來看，銷售成本顯然包括製造產品的成本，還包括第三方特許權使用費和其他一些期間費用、分銷費用等，這些都流經那裡。

As well as period costs associated with idle capacity and we talked a little bit about that at the end of last year, even when we dig into the product cost itself in kind of the components there, the two majority and most significant drivers here is really the cost of the product that was sold and recorded as sales in the period. As well as what I referred to those orders that were delivered to the treatment center but not yet booked as product sales, they're showing up in deferred revenue on the balance sheet.

除了與閒置產能相關的期間成本（我們在去年年底對此進行了一些討論），即使我們深入研究產品成本本身的組成部分，這裡最重要的兩個驅動因素實際上是銷售並記錄為期間銷售額的產品成本。以及我提到的那些已交付至治療中心但尚未記入產品銷售的訂單，它們在資產負債表上顯示為遞延收入。

That's going to make up the majority of the product costs related to patients. There are typical, smaller pieces that are going to be associated with patient assistance programs or canceled or kind of scrap batches, for lack of a better word, but we expect those to be, they're consistent with kind of practice and what you would kind of put through cost of sales but certainly not driving the vast majority of those costs.

這將佔與患者相關的產品成本的大部分。有一些典型的、較小的部件將與患者援助計劃或取消或報廢批次相關，因為沒有更好的詞來形容，但我們預計這些是，它們與實踐和你將投入的銷售成本一致，但肯定不會導致絕大多數成本。

I don't think we'll get into specifics, kind of patient by patient, on that front. I think the other piece here too is just again to know the cost associated with all that is in particular for the first quarter here, at a relatively inefficient level of utilization on the plant, so there are idle charges as we even saw come through in the fourth quarter of last year when we kind of had to make that change on the accounting front following the approval of basically idle capacity charges that are coming through on a period expense basis and cost of sales.

我認為我們不會針對每位患者俱體討論這一方面的問題。我認為這裡的另一點也是再次了解與所有這些相關的成本，特別是在第一季度，工廠的利用率相對較低，因此存在閒置費用，就像我們在去年第四季度看到的那樣，在批准了基本上按期間費用和銷售成本產生的閒置產能費用後，我們不得不在會計方面做出這種改變。

So, I'll leave it.

所以，我就不說了。

There to disclose the deferred revenues because it's not broken out in the consolidated balance sheet on the income statement. I assume it'll come in the 10 queue?

需要揭露遞延收入，因為它沒有在損益表的合併資產負債表中列出。我猜它會出現在 10 隊列中？

Yes, that will be broken out.

是的，那將會被打破。

It's the amount was about $4.7 million. Matt. It'll be broken out on that.

其金額約為470萬美元。馬特。這件事將會被揭露。

Thanks.

謝謝。

Yes. All right. And then the second question was related to the profile that we've seen for obe-cel in the CARSLYLE study. One of the key things that we're really pleased with from the from the study is the consistency on how the product is performed, and one of the two key parameters to sort of understand performance. One is the expansion that you do get with the product. Which gives you a lot of information about the quality of the product and the consistency of the product and what we're seeing is a very consistent expansion and then also very consistent persistence as Matt was pointing out somewhat longer than I think what we have seen with some of the other khaki products.

是的。好的。第二個問題與我們在 CARSLYLE 研究中看到的 obe-cel 概況有關。我們從研究中真正感到滿意的關鍵因素之一是產品效能的一致性，也是了解效能的兩個關鍵參數之一。一是產品確實能帶來擴充。這為您提供了大量有關產品品質和產品一致性的信息，我們看到的是一種非常一致的擴展，然後也是非常一致的持久性，正如馬特指出的那樣，我認為比我們在其他一些卡其色產品上看到的要長一些。

I think what is obviously very encouraging is that what we're seeing is very consistent with what our experience is for obe-cel across all indications that we actually evaluated to date. And it is that consistency in the quality, higher levels of expansion than what others have been reporting, obviously in acute leukemia, exceptional persistence. But also here somewhat longer persistence that was observed with other programs. We think that is very important because obviously you need it's a cell-based therapy in order to get a deep cut into the compartment.

我認為顯然非常令人鼓舞的是，我們所看到的情況與我們迄今為止實際評估的所有跡象表明的 obe-cel 的經驗非常一致。而且它的品質一致性、擴張水平高於其他人所報告的水平，顯然在急性白血病中具有出色的持久性。但在這裡也觀察到了比在其他程序中觀察到的時間稍長的持久性。我們認為這非常重要，因為顯然你需要一種基於細胞的療法才能深入到隔間。

The cells actually have to stick around. They have to move around. They have to make compact, and they have to eliminate physically each one of the B cells that are in that body and so that is a job that takes a certain amount of time and so you do need to have a certain amount of minimum persistence to actually complete the job and we'll leave the fact that we have a somewhat higher or longer persistence than what others have observed I think is a good thing and I think should give us a very deep, very consistent depletion of the B cell compartment in these patients.

細胞實際上必須停留在原處。他們必須四處走動。它們必須緊密結合，並且必須從物理上消除體內的每一個 B 細胞，所以這項工作需要一定的時間，所以你確實需要有一定的最低持久性才能真正完成這項工作，事實上，我們的持久性比其他人觀察到的要高一些或更長一些，我認為這是一件好事，我認為應該能讓我們在這些患者體內非常深入、非常持續地消耗 B 細胞室。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Asthika Goonewardene from Truist.

我們的下一個問題來自 Truist 的 Asthika Goonewardene。

Hi guys, it's Karina for Asthika. Congrats on the great quarter. I have a question on the 20% of whatever quarter drop for CAR T-cell, which was reported by Gilliard in 1. Can you quantify how many patients treated would have been eligible for CAR T-cell?

大家好，我是 Asthika 的 Karina。恭喜本季取得如此出色的成績。我對 Gilliard 在 1 中報告的 CAR-T 細胞季度下降 20% 有一個疑問。您能否量化有多少接受治療的患者有資格接受 CAR T 細胞治療？

Yeah.

是的。

Hi, Karina, thanks for joining. Interesting question, obviously one that we cannot really get, have a good resolution for because when you think about the labels that go into the CAR T-cell sales, they include both. The mantle cell lymphoma label as well as the ALL label, we do know that Brianzi obviously has started to expand its use in mantle cell lymphoma, which is sort of actually quite a bit ahead of our own launch.

你好，Karina，感謝你的加入。這是一個有趣的問題，顯然我們無法真正找到一個很好的解決方案，因為當你考慮 CAR-T 細胞銷售的標籤時，它們包括兩者。套細胞淋巴瘤標籤以及 ALL 標籤，我們確實知道 Brianzi 顯然已經開始擴大其在套細胞淋巴瘤中的用途，這實際上比我們自己的推出要領先很多。

So, it's very difficult to actually try to triangulate, I think what might be a contribution on the ALL side versus the mental cell side. I think it's reasonable to assume that the majority is probably coming from the mental side. That sort of contributed to the somewhat reduced level of sales that were reported.

因此，實際上嘗試三角測量是非常困難的，我認為所有方面與精神細胞方面的貢獻可能是什麼。我認為可以合理地假設，大多數可能來自精神方面。這在一定程度上導致了報告的銷售水準下降。

Okay, and can you also comment on the median turnaround time so far in the manufacturing success rate?

好的，您能否評論一下迄今為止製造成功率的平均週轉時間？

Yeah, so the turnaround time is very much in line of what we were targeting. So, our target is to get to 16 days. Remember our experience in the FELIX trial was around 21 days, and so we're tracking very nicely towards the 16. So that's, I think, kind of what we were hoping for, kind of where we are.

是的，所以周轉時間與我們的目標非常一致。因此，我們的目標是達到 16 天。請記住，我們在 FELIX 試驗中的經驗是大約 21 天，因此我們正順利地追蹤 16 天。所以，我想，這就是我們所希望的，也是我們現在的狀況。

And in terms of the success rate, that's something that I think is premature to talk about. Overall, I would say the fact that we have are out of the gate, the way that we actually got out of the gate indicates that we've been firing on all cylinders with good quality products.

至於成功率，我認為現在談論還為時過早。總的來說，我想說我們已經走出了大門，我們走出大門的方式實際上表明我們已經全力以赴生產高品質的產品。

Okay, thank you.

好的，謝謝。

Thank you.

謝謝。

Thank you. Our next question one moment for our next question.

謝謝。我們的下一個問題是，稍後再問下一個問題。

Our next question comes from the line of Gil Blum from Needham and Company.

我們的下一個問題來自 Needham and Company 的 Gil Blum。

Good morning everyone, and allow me to add my congratulations for a strong first quarter. So maybe addressing the same topic in a slightly different manner. Is it fair to assume that every single patient that was treated in the first quarter would have otherwise received a competing CAR T, or do you think you're starting to see some levels of expanding on the potential patient pool?

大家早安，請容許我對第一季的強勁表現表示祝賀。因此，也許可以用稍微不同的方式來討論同一主題。是否可以公平地假設第一季接受治療的每位患者都會接受競爭性 CAR T 治療，或者您認為開始看到潛在患者群體在某種程度上有所擴大？

It is a really good question, Gil and thanks for joining. It feels like particularly as you, quite often when you launch a product, and depending on the experience of a center, if there's a center that doesn't have the experience with your product, you typically get patients that are in pretty poor condition.

這是一個非常好的問題，吉爾，感謝您的參與。感覺就像您經常在推出產品時，根據中心的經驗，如果某個中心沒有使用過您的產品，那麼您通常會遇到病情相當糟糕的患者。

And so there is a sense that there are probably patients in there that might not have been considered for a CAR T therapy before. So, I think sort of on the worst end of the spectrum, I think we have certainly patients in there that were certainly part of that really difficult to treat category.

因此，有一種感覺是，其中可能有些患者以前可能沒有考慮過接受 CAR T 療法。所以，我認為在最糟糕的情況下，我們肯定有一些患者屬於真正難以治療的類別。

Whether we had, we're starting to see sort of, patients on the upside, so with low tumor burden or early relapse, I think that's too early to call. But I think we're clearly having patients that are probably would have not been considered for CAR T therapy before, in some of the centers that we had seen in Cuba.

無論我們是否有，我們都開始看到患者病情好轉，即腫瘤負擔較低或復發較早，我認為現在下結論還為時過早。但我認為，我們在古巴的一些醫療中心顯然有一些患者以前可能不會被考慮接受 CAR T 療法。

Okay. And as it relates to your update that's upcoming for autoimmune disease. Just remind us of at the data is going to probably include here, a number of patients follow up and the increased dose as well.

好的。這與您即將發布的有關自體免疫疾病的更新有關。只是提醒我們，數據可能包括一些患者的追蹤以及增加的劑量。

Right, so I would say at this point we have six patients that are somewhere between 1 month and 8 months of follow up. So, all of these patients, these six will all be, I think, well beyond, sort of the 5 months to 6 months range, all of those. So, I think that gives us sort of a good understanding of the behavior of the product in from a longer term and the recovery for the B cell compartment in those patients.

好的，我想說的是，目前我們有六名患者的追蹤時間在 1 個月到 8 個月之間。所以，我認為，所有這些患者，這六名患者的存活時間都將遠遠超出 5 個月到 6 個月的範圍。因此，我認為這讓我們能夠很好地了解該產品的長期行為以及這些患者 B 細胞區的恢復情況。

In addition, what we, what we're currently doing is we're dosing three patients at 100 million cell doses twice of what we have used in the first six, and we're planning to also treat three adolescent patients at the 50 million dose level and hopefully we have those patients included in the update by the end of the year.

此外，我們目前正在對三名患者進行 1 億個細胞劑量的治療，該劑量是前六名患者的兩倍，我們還計劃對三名青少年患者進行 5000 萬個劑量的治療，希望我們能在今年年底前將這些患者納入更新範圍。

Great, thanks for taking our questions.

太好了，感謝您回答我們的問題。

Thanks a lot.

多謝。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Yanan Zhu from Wells Fargo.

我們的下一個問題來自富國銀行的朱亞南。

Great, thanks for taking our questions and congrats on the very strong launch of AUCATZYL, was wondering, can you remind us of the, of the Takata's current revenue, what percentage by your estimate could be coming from B-ALL? It feels as though that, just in the first quarter of launch, you have achieved very significant market share in B-ALL, given that, BF current sales is only 80 roughly $80 million and at peak it was only $100 million and yeah, give us a sense of the proportion of B-ALL in there in the proportion of that's B-ALL. Thanks.

太好了，感謝您回答我們的問題，並祝賀 AUCATZYL 的強勢推出，我想知道，您能否提醒我們，在高田目前的收入中，您估計有多少百分比可能來自 B-ALL？感覺好像在推出的第一季度，你們就在 B-ALL 中取得了非常可觀的市場份額，考慮到 BF 目前的銷售額只有 8000 萬美元，高峰期也只有 1 億美元，是的，讓我們了解一下 B-ALL 在 B-ALL 中所佔的比例。謝謝。

Thanks Yanan. Very difficult question to answer actually because it's never been properly broken out and with the dynamic we're seeing with Brianzi moving in, it's kind of hard to tell where that split is between the indications. When we look back, probably 12 years ago, it might have been. Somewhere between, 20% and 40% being ALL patients, but it's actually it's a hard thing to actually estimate.

謝謝亞南。實際上，這是一個很難回答的問題，因為它從未被正確地分解過，而且隨著我們看到 Brianzi 的加入，我們很難說出這些跡象之間的分歧在哪裡。當我們回顧時，大概 12 年前，情況可能就是這樣。大約 20% 到 40% 是所有患者，但實際上很難估計。

Because there's not a real clear data set that he could actually delineate it from, so it's the majority of what would have expected to be mental cell patients, a minority to be ALL, but how that has moved now with the change of Brianzi moving into the MCL side, very difficult to estimate. I don't think we can give you a good answer there.

因為沒有真正清晰的數據集可以讓他真正地描述出來，所以大多數預計是精神細胞患者，少數是 ALL，但隨著 Brianzi 轉到 MCL 方面，現在情況如何變化，很難估計。我認為我們無法給你一個好的答案。

Got it. And then secondarily, given the information that $4.7 million is in a deferred revenue line would be products that's delivered but not yet infused. So, two clarifying questions. One, so this $4.7 million will represent the cost and not the actual price that you will receive from the product if that whether that's the correct impression and?

知道了。其次，根據資訊顯示，遞延收入中有 470 萬美元是已交付但尚未註入的產品。因此，有兩個需要澄清的問題。第一，這 470 萬美元代表的是成本，而不是您從產品中獲得的實際價格，這是否是正確的印象？

Two, typically, what is the time between receipt reception of the product and then infusion. I'd imagine it's a pretty short turnaround and if that's the case then this $4.7 million would already be translating to like a $9 million. We're only, early in the quarter? so just want to get a sense of those two questions.

二、通常，從收到產品到輸液需要多長時間。我想這是一個相當短的周轉時間，如果是這樣的話，那麼這 470 萬美元就已經轉化為 900 萬美元了。我們才剛進入本季初？我只是想了解這兩個問題。

Thanks. So, I'll answer the second question and then hand over to Rome for the first question. The time of dosing is quite variable in the commercial setting for these patients. So, there is a the with a lot of these patients, you have quite a lot of variability in terms of the state, the condition that they're in. So, some of these patients may have picked up an infection and that was actually something you have to kind of go through. You have to treat. You have to get them back to a reasonable state before you dose.

謝謝。那麼，我先回答第二個問題，然後把第一個問題交給羅馬。在商業環境中，這些患者的給藥時間差異很大。因此，對於許多這樣的患者來說，他們的狀態和病情有很大的差異。因此，其中一些患者可能已經感染，這實際上是必須經歷的事情。你必須治療。你必須讓它們恢復到合理狀態後再服藥。

Other patients are in good shape, can be brought in, and can be dosed quickly. So, it is actually quite a wide range, that we're seeing, and I don't think we have yet a good feel of where kind of the sort of the bulk of the patients will be landing on. But it is variable based on sort of the underlying comorbidities of the patients and frankly the issues that they're encountering as a consequence of the advanced stage of their disease.

其他病人狀況良好，可以送入，並能快速服藥。所以，我們看到的範圍實際上相當廣泛，我認為我們還不能很好地了解大部分患者會落在哪裡。但它會根據患者的潛在合併症以及坦率地說他們因疾病晚期而遇到的問題而有所不同。

So, it is variable and it's more variable than what we have seen during the clinical trial. There's more variability there. So, I think as we sort of get more experience and probably have a few, more quarters in, I think we start to probably have a better sense of kind of what the actual. Numerical ranges will be, but at this point clearly, it's somewhat larger than what we have observed, in the FELIX study. With that handing over to Rob for the first part of the question.

所以，它是可變的，並且比我們在臨床試驗中看到的更具可變性。那裡有更多的變化。所以，我認為隨著我們獲得更多經驗，並且可能經歷更多季度，我們可能會開始更好地了解實際情況。數值範圍會是，但目前顯然比我們在 FELIX 研究中觀察到的要大一些。接下來，問題的第一部分就交給 Rob 回答。

Hi Ian, so yeah, let me clarify on the deferred revenue piece. So, the deferred revenue represents the sales value. It's not the cost of the product. So, the way to think about product that was delivered to the treatment centers that got administered, reflected in the P&L on the $9 million, the value of that product or the revenue value of that product. Not yet recognized in the P&L sits as deferred revenue. So that's kind of the total piece to think about that.

嗨，伊恩，是的，讓我澄清一下遞延收入部分。因此，遞延收入代表銷售價值。這不是產品的成本。因此，請思考一下運送到治療中心並進行管理的產品，這反映在 900 萬美元的損益表中，即該產品的價值或該產品的收入價值。尚未在損益表中確認為遞延收入。這就是要思考的整個問題。

Now, the piece is a little bit, maybe counter intuitive is when you do start to think about the cost for that. All of the cost for both the deferred revenue amount and patience as well as the P&L recognized amount, do sit in our Q1 cost the sales line and the reason for that largely is once we deliver product to the center, we no longer really can hold that as inventory and becomes kind of an immediate expense item.

現在，當你開始考慮這件事的成本時，也許會覺得有點違反直覺。遞延收入金額和耐心以及損益確認金額的所有成本都包含在我們第一季的銷售成本中，其主要原因是，一旦我們將產品交付到中心，我們就不再能夠將其作為庫存持有，而成為一種即時費用項目。

Once it's delivered and so Christian, alluded to there is some time and some variability around that. You also, for example, could have patients where we've delivered the product reflected in deferred revenue and unfortunately a patient passes away and so that would actually still wind up have been accounted for in your cost of sales but would be deferred revenue that you may not realize.

一旦它被傳遞，那麼基督教就暗示著這需要一些時間和一些變化。例如，您可能有患者，我們已向其交付了產品，這反映在遞延收入中，但不幸的是，患者去世了，因此這筆收入實際上仍計入您的銷售成本，但這可能是您沒有意識到的遞延收入。

Got it. This is all super helpful.

知道了。這一切都非常有幫助。

Thank you for the explanation. Yeah, if I may one last question perhaps for Christian, can you give us a sense in terms of your positioning in the competitive landscape for lupus nephritis with your planned dosing of first patient by year '25, where are you vis a vis other companies who also is interested or are already taking on lupus nephritis for erythematosus.

謝謝你的解釋。是的，如果我可以問克里斯蒂安最後一個問題，您能否給我們介紹一下您在狼瘡性腎炎競爭格局中的定位，您計劃在 25 年之前為第一位患者進行給藥，與其他對紅斑狼瘡性腎炎感興趣或已經在進行治療的公司相比，您處於什麼位置。

Thank you.

謝謝。

Thanks Yanan. I think we're very well positioned, and the combination obviously is of having a very compact study design, as well as also being, well set up in many of the clinical centers, in the US and we're obviously. Are gearing up in the UK as well from a commercial perspective, I think we should set us up well in our ability to deliver the trial. So, we believe we're very well positioned with that.

謝謝亞南。我認為我們處於非常有利的位置，顯然，我們的結合點在於擁有非常緊湊的研究設計，並且在美國的許多臨床中心都有良好的設置，我們顯然如此。從商業角度來看，我們也在英國做好了準備，我認為我們應該做好進行試驗的準備。因此，我們相信我們在這方面處於非常有利的地位。

Many of the trials that have been in the lupus space more generally that have been sort of considered or are underway are randomized controlled studies with substantially larger patient numbers, and those types of studies have been notoriously challenging to recruit. If you look at the [Bennelo] etc. Experience in the space, the patient numbers are 1 patients to 2 patients percent per year, that we see and so conducting these larger studies will take, or can take, a good amount of time.

許多在狼瘡領域中已經考慮或正在進行的試驗都是隨機對照研究，涉及的患者數量要大得多，而這些類型的研究的招募工作一直非常具有挑戰性。如果你看一下 [Bennelo] 等人在該領域的經驗，你會發現患者數量每年佔 1% 到 2%，因此進行這些更大規模的研究將需要，或者說可能需要相當長的時間。

Very helpful. Thanks and congrats on the on.

非常有幫助。謝謝並祝賀你。

Thanks a lot. I appreciate It.

多謝。我很感激。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Kelly Shi from Jeffrey's.

我們的下一個問題來自 Jeffrey's 的 Kelly Shi。

Hi, this is Ian from Jeffries on behalf of Kelly. Thank you for taking my question and congratulations on a very strong Q1. I have a question on the lupus phase 2 trial. I'm wondering like how many patients you expected to enroll in the phase 2 and More importantly, probably like what's your expected patient follow up to balance your strategy to like faster market and in the meantime it can show the cell therapist's potential in induced like durable drug free remission.

大家好，我是 Jeffries 的 Ian，代表 Kelly。感謝您回答我的問題，並祝賀您在第一季取得了非常強勁的成績。我對狼瘡 II 期試驗有一個疑問。我想知道您預計在第 2 階段招募多少名患者，更重要的是，您可能希望對患者進行哪些跟進，以平衡您的策略以加快市場速度，同時展示細胞治療師在誘導持久無藥物緩解方面的潛力。

Thank you.

謝謝。

Well, thanks for joining. We had indicated that the, at the R&D day that we're expecting the study to be at around 30 patients. It's relatively compact study, as indicated. And in terms of follow up, when you look at other studies in the space, you do see that, you have meaningful follow up in these patients with a year follow up.

好的，感謝您的加入。我們在研發日時曾表示，預計這項研究將涉及約 30 名患者。如上所述，這是一項相對緊湊的研究。就隨訪而言，當您查看該領域的其他研究時，您確實會看到，對這些患者進行了為期一年的有意義的隨訪。

Also, you can also follow these patients further, but you get a pretty good sense within a year from a value perspective. The actual readout that we expect to be able to go for could be shorter than that, given the time and dynamic that we've seen in terms of the response. Development in these patients, but I think one year is a reasonable period of time to consider.

此外，您還可以進一步追蹤這些患者，但從價值角度來看，您將在一年內得到相當好的感覺。考慮到我們所看到的反應時間和動態，我們預計能夠得到的實際讀數可能會比這更短。這些患者的發展，但我認為一年是一個合理的考慮時間。

Thank you.

謝謝。

Thank you. This concludes today's Q&A session. I would now like to turn the conference back over to Christian Ian, CEO for closing remarks.

謝謝。今天的問答環節到此結束。現在，我想將會議交還給執行長 Christian Ian 來致閉幕詞。

Thanks a lot. Well, thanks everybody for joining. Fantastic to sort of give you the update. I know you're very keen to hear how we're doing for the first quarter. It was a great quarter. We're looking forward to keeping you updated as we go through the rest of the year, but we're very excited about where we are and we're going to push hard.

多謝。好吧，感謝大家的加入。很高興向您提供最新進展。我知道您非常想知道我們第一季的業績表現。這是一個偉大的季度。我們期待在今年剩餘的時間向您通報最新情況，但我們對目前的狀況感到非常興奮，並且會努力奮鬥。

Thank you very much.

非常感謝。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating. You may now disconnect.

感謝您的參與。您現在可以斷開連線。