Fate Therapeutics Inc (FATE) 2024 Q1 法說會逐字稿

Welcome to the Fate Therapeutics first quarter 2024 financial results conference call. (Operator Instructions) As a reminder, today's call is also being recorded.

歡迎參加 Fate Therapeutics 2024 年第一季財務業績電話會議。（操作員指示）提醒一下，今天的通話也將被錄音。

I would now like to turn -- I would now like to introduce Scott Wolchko, President and CEO of Fate Therapeutics. Please go ahead.

現在我想介紹一下 Fate Therapeutics 總裁兼執行長 Scott Wolchko。請繼續。

Thank you. Good afternoon, and thanks, everyone, for joining us for the Fate Therapeutics first quarter 2024 financial results call. Shortly after 4:00 PM, Eastern Time today, we issued a press release with these results, which can be found on the investors section of our website under press releases. In addition, our Form 10-Q for the quarter ended March 31, 2024 was filed shortly thereafter and can be found on the Investors section of our website under financial information.

謝謝。下午好，感謝大家參加 Fate Therapeutics 2024 年第一季財務業績電話會議。今天美國東部時間下午 4:00 後不久，我們發布了一份新聞稿，其中包含這些結果，您可以在我們網站的投資者部分的新聞稿中找到。此外，我們截至 2024 年 3 月 31 日的季度 10-Q 表已於此後不久提交，可在我們網站的「投資者」部分的財務資訊下找到。

Before we begin, I would like to remind everyone that except for statements of historical fact, THE statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

在我們開始之前，我想提醒大家，除了歷史事實陳述外，管理層在電話會議上所作的陳述和對問題的回答都是根據 1995 年《私人證券訴訟改革法》安全港條款做出的前瞻性陳述。這些聲明涉及風險和不確定性，可能導致實際結果與此類前瞻性聲明的結果有重大差異。

Please see the forward-looking statement disclaimer on the company's earnings press release issued after the close of market today, as well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2024, that was filed with the SEC today.

請參閱本公司今天收盤後發布的收益新聞稿中的前瞻性聲明免責聲明，以及我們今天向美國證券交易委員會提交的截至 2024 年 3 月 31 日的季度 10-Q 表中包含的風險因素。

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made as facts and circumstances underlying these forward-looking statements may change. Except as required by law, Fate Therapeutics disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

不應過度依賴前瞻性陳述，這些陳述僅代表其作出之日的觀點，因為這些前瞻性陳述所依據的事實和情況可能會改變。除法律要求外，Fate Therapeutics 不承擔更新這些前瞻性陳述以反映未來資訊、事件或情況的義務。

Joining me on today's call are Ed Dulac, our Chief Financial Officer; and Dr. Bob Valamehr, our Chief Research and Development Officer. We will focus today's remarks on the data presented today at the American Society of Gene and Cell Therapy Annual Meeting for our off-the-shelf FT819 CAR T cell and FT522 CAR NK cell programs. And discuss key program initiatives that we are pursuing to achieve therapeutic differentiation and improved patient outcomes.

參加今天電話會議的還有我們的財務長 Ed Dulac；以及我們的首席研發長 Bob Valamehr 博士。我們今天的演講將重點放在今天在美國基因和細胞治療學會年會上展示的我們現成的 FT819 CAR T 細胞和 FT522 CAR NK 細胞計畫的數據。並討論我們為實現治療差異化和改善患者預後而正在推行的關鍵計劃舉措。

In addition, we will highlight clinical readouts that we are projecting to achieve in 2024 across our IPSC product pipeline for the treatment of cancer and autoimmune diseases.

此外，我們將重點介紹我們預計在 2024 年透過 IPSC 產品線實現的用於治療癌症和自體免疫疾病的臨床讀數。

Finally, we will review our financial position for our first quarter capital raise and strong cash balance have created operating runway into the second half of 2026. Beginning with FT819, our off-the-shelf CD19 targeted CAR T cell program. Today at the ASGCT Annual Meeting, we presented translational data from our FT819 Phase 1 study in relapse refractory B-cell malignancies, which show that a single dose of FTA19 exhibited multiple mechanisms of action implicated in generating an immune reset in patients with B-cell mediated autoimmune diseases.

最後，我們將審查第一季的財務狀況，強勁的現金餘額為 2026 年下半年的營運奠定了基礎。從 FT819 開始，我們的現成 CD19 靶向 CAR T 細胞程序。今天在 ASGCT 年會上，我們展示了復發難治性 B 細胞惡性腫瘤中 FT819 第 1 階段研究的轉化數據，這些數據表明單劑量 FTA19 表現出多種作用機制，與在患有 B 細胞介導的自身免疫性疾病的患者中產生免疫重置有關。

The translational data supporting these mechanisms included rapid, deep, and sustained CD19 positive B-cell depletion in the peripheral blood, patient case studies of primary, secondary, and tertiary tissue trafficking, infiltration and activity with CD19 positive B-cell elimination in tissue and patient case studies of plasma cell depletion and B-cell reconstitution with recovery of naive B cells and little to no recovery of activated memory B cells or plasma blasts.

支持這些機制的轉化數據包括週邊血液中快速、深度和持續的 CD19 陽性 B 細胞耗竭，患者病例研究的原發性、繼發性和三級組織運輸、浸潤和活動以及組織中 CD19 陽性 B 細胞的消除，以及患者病例研究的漿細胞耗竭和 B 細胞重建，其中幼稚 B 細胞恢復，而活化 B 細胞或漿母細胞幾乎沒有記憶恢復。

Notably we also presented patient case studies demonstrating rapid deep and sustained B cell depletion accompanied by clinical responses without the use of fludarabine as a conditioning agent. Collectively, we believe these data support the disease-modifying potential of FT819 for patients with B-cell mediated autoimmune diseases.

值得注意的是，我們也提供了患者案例研究，證明在不使用氟達拉濱作為調理劑的情況下，B 細胞迅速深度和持續耗竭，並伴隨臨床反應。總的來說，我們相信這些數據支持 FT819 對 B 細胞介導的自體免疫疾病患者的疾病改良潛力。

To that end, I am pleased to announce that the first lupus patient has been treated in our Phase 1 autoimmunity study of FT819. This first patient, a 27 year old woman with refractory disease, despite having previously been treated with multiple standard of care therapies received conditioning chemotherapy, followed by a single dose of FT819 at 360 million cells. The patient was discharged after a three day hospitalization stay without any notable adverse events.

為此，我很高興地宣布，我們在 FT819 的第一階段自體免疫研究中已經治療了第一位狼瘡患者。第一位患者是一位患有難治性疾病的 27 歲女性，儘管之前已接受過多種標準治療，但仍接受了預處理化療，隨後接受了單劑量 3.6 億個細胞的 FT819 治療。患者住院三天後出院，沒有任何明顯的不良事件。

At ASGCT today, we also presented promising data from a first-of-a-kind translational assay using a sample of the patient's blood obtained prior to administration of conditioning chemotherapy, where we observed rapid and potent depletion of the patient's CD19 positive B-cells in an ex vivo cytotoxicity assay with FT819.

今天在 ASGCT 上，我們還展示了一項首創的轉化分析的有希望的數據，該分析使用了在進行預處理化療之前獲得的患者血液樣本，我們在使用 FT819 進行的體外細胞毒性分析中觀察到患者 CD19 陽性 B 細胞的快速而強烈的消耗。

It is worthwhile to note that treatment of this first patient occurred within weeks of site activation. We believe this patient experience exemplifies the potential of an off-the-shelf cell therapy to overcome challenges that may hinder autologous cell therapies in reaching patients with autoimmune diseases, including the need for apheresis, complex manufacturing and treatment logistics, and extended patient hospitalization.

值得注意的是，第一位患者的治療是在站點啟動後的幾週內進行的。我們相信，這種患者的經驗體現了現成的細胞療法的潛力，可以克服可能阻礙自體細胞療法惠及自體免疫疾病患者的挑戰，包括需要進行血液分離、複雜的製造和治療物流以及延長患者住院時間。

Furthermore, since we have observed deep B-cell depletion and clinical responses without the use of fludarabine as a conditioning agent in our Phase 1 study of FT819 for B-cell malignancies, we believe FT819 may have disease-modifying potential in autoimmunity using alternative conditioning regimens.

此外，由於我們在 FT819 治療 B 細胞惡性腫瘤的第 1 階段研究中觀察到了深度 B 細胞耗竭和臨床反應，而無需使用氟達拉濱作為調理劑，因此我們相信 FT819 可能具有使用替代調理方案在自身免疫方面改變疾病的潛力。

We plan to amend the current clinical protocol for our Phase 1 autoimmunity study in the second quarter of 2024 to enable FT819 administration with single agent Cytoxan at the same dose used by rheumatologists for treatment of patients with autoimmune disease. We believe that an off-the-shelf add-on of FT819 to commonly used treatment regimens may contribute to a highly differentiating patient experience.

我們計劃在 2024 年第二季度修改我們第 1 階段自體免疫研究的當前臨床方案，以便 FT819 與單一藥物 Cytoxan 一起給藥，劑量與風濕病學家用於治療自體免疫疾病患者的劑量相同。我們相信，將現成的 FT819 添加到常用的治療方案中可能會為患者帶來高度差異化的體驗。

Dose escalation in our FT819 Phase 1 study in relapsed refractory B-cell malignancies has now completed, where 43 patients were treated with a single dose of FT819 at up to 1 billion cells, without HLA matching. We observed clinical responses, including complete responses in heavily pretreated patients with aggressive disease, including in relapse refractory large B-cell lymphoma patients that were previously treated with autologous CD19 targeted CAR-T cell therapy.

我們針對復發性難治性 B 細胞惡性腫瘤的 FT819 第 1 期研究的劑量遞增現已完成，其中 43 名患者接受了單劑量 FT819 治療，劑量高達 10 億個細胞，無需 HLA 匹配。我們觀察到了臨床反應，包括接受過大量治療的侵襲性疾病患者的完全反應，包括先前接受過自體 CD19 標靶 CAR-T 細胞療法治療的複發性難治性大 B 細胞淋巴瘤患者。

The safety and tolerability profile of FT819 was favorable with no dose-limiting toxicities, no events of any grade of ICANs or graft versus host disease and low incidence of only low grade CRS. We believe the established clinical safety and tolerability profile of FT819 is differentiated and may also be of significant import for treatment of patients with autoimmune diseases. At this time, we intend to focus all further clinical development of FT819 exclusively in autoimmunity.

FT819 的安全性和耐受性良好，沒有劑量限制性毒性，沒有任何等級的 ICAN 或移植物抗宿主疾病事件，且僅發生低度 CRS 的發生率較低。我們相信，FT819 已建立的臨床安全性和耐受性概況具有差異性，對於治療自體免疫疾病患者也可能具有重要意義。目前，我們打算將 FT819 的所有進一步臨床開發重點集中在自體免疫方面。

Today at the ASGCT Annual Meeting, we also presented data from our FT522 off-the-shelf CD19 targeted CAR NK cell program, which is the first product candidate emerging from our IPSC product platform that incorporates our alloimmune defense receptor technology.

今天在 ASGCT 年會上，我們也展示了 FT522 現成的 CD19 靶向 CAR NK 細胞計劃的數據，這是我們 IPSC 產品平台中第一個採用同種免疫防禦受體技術的候選產品。

Today, the treatment course for administration of cell-based immunotherapies, including both autologous and allogeneic cell therapies, requires conditioning patients with chemotherapy. Conditioning chemotherapy can induce toxicities prevent combination with standard of care treatments widely used in the community-based settings and limit patient access and reach.

如今，包括自體細胞療法和同種異體細胞療法在內的細胞免疫療法的治療過程都需要對患者進行化療。預處理化療可能會引起毒性，因此無法與社區環境中廣泛使用的標準治療相結合，並限制患者的治療機會和覆蓋範圍。

ADR technology incorporated into 522 is designed to enable effective treatment without administration of conditioning chemotherapy to patients, which we believe has the potential to redefine the cell therapy treatment paradigm.

522 中融入的 ADR 技術旨在實現無需對患者進行化療即可進行有效治療，我們相信這有可能重新定義細胞療法治療模式。

We have previously presented preclinical data using cancer cell lines, demonstrating that the coal culture of ADR on CAR NK cells with alloreactive T cells promotes NK cell proliferation, enhances NK cell persistence, and increases anti-tumor activity indicating that arming with ADR technology has the potential to enable effector cell function in the presence of an alloreactive system.

我們先前曾使用癌細胞系展示了臨床前數據，證明在具有同種反應性 T 細胞的 CAR NK 細胞上進行 ADR 共培養可促進 NK 細胞增殖、增強 NK 細胞持久性並提高抗腫瘤活性，這表明採用 ADR 技術有可能在同種反應系統存在的情況下實現效應細胞功能。

Today at the ASGCT Annual Meeting, we reported preclinical data using SLE diseased cells. In a novel rechallenge assay using peripheral blood mononuclear cells from an unmatched SLE donor FT522 uniquely drove a rapid and deep depletion of CD19 positive donor B-cells, eliminated alloreactive donor T cells and maintained functional persistence with the ability to sell additional CD19 positive donor B cells upon rechallenge.

今天在 ASGCT 年會上，我們報告了使用 SLE 病變細胞的臨床前數據。在使用來自不匹配的 SLE 供體的外周血單核細胞進行的新型再攻擊試驗中，FT522 以獨特的方式快速深度消耗 CD19 陽性供體 B 細胞，消除同種反應性供體 T 細胞，並保持功能持久性，並能夠在再攻擊時出售額外的 CD19 陽性供體 B 細胞。

In addition, we also presented initial translational data from the first two patients treated in our ongoing Phase 1 study of FT522 in relapse refractory B cell lymphoma. These data show enhanced persistence of 522 in the periphery compared to clinical data observed with FT596, our prior generation CD19 targeted CAR NK cell without ADR technology.

此外，我們也展示了我們正在進行的 FT522 治療復發難治性 B 細胞淋巴瘤的 1 期研究中前兩名患者的初步轉化數據。這些數據顯示，與我們上一代 CD19 靶向 CAR NK 細胞（無 ADR 技術）FT596 的臨床數據相比，522 在周邊的持久性增強。

Importantly, these data also show rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle. We intend to submit an IND application to the FDA in the middle of 2024 to expand our clinical investigation of FT522 for treatment of various B cell mediated autoimmune diseases, including without administration of conditioning chemotherapy to patients.

重要的是，這些數據也顯示在整個一個月的治療週期內，週邊 B 細胞的消耗迅速、深度且持續。我們打算在 2024 年中期向 FDA 提交 IND 申請，以擴大我們對 FT522 的臨床研究，用於治療各種 B 細胞介導的自身免疫性疾病，包括不對患者進行預處理化療。

I'm also pleased to report that the first three patients in the conditioning arm of our Phase 1 study of FT522 for relapsed refractory B-cell lymphoma have now completed safety assessment without any dose-limiting toxicities. And there were no events of any grade of CRS, ICANS or GvHD. Dose escalation is now ongoing at 900 million cells per dose.

我還很高興地報告，我們針對復發難治性 B 細胞淋巴瘤的 FT522 第一階段研究預處理組中的前三名患者現已完成安全性評估，並且沒有任何劑量限制性毒性。並且沒有發生任何層級的 CRS、ICANS 或 GvHD 事件。目前劑量正在逐步增加，每劑9億個細胞。

In addition, patient enrolment has now been initiated in the no conditioning arm at 300 million cells per dose. And we are poised to clinically assess the safety and activity of our ADR armed FT522 CAR NK cell program without administration of conditioning chemotherapy to patients.

此外，目前已開始在無預處理組中招募患者，每劑含 3 億個細胞。我們準備在無需對患者進行預處理化療的情況下，對裝有 ADR 的 FT522 CAR NK 細胞計劃的安全性和活性進行臨床評估。

Turning to our solid tumor initiatives, I'm also pleased to announce that under our collaboration with Ono Pharmaceutical, we have recently treated the first patient in our Phase 1 study of FT825 designed using the company's IPSC product platform, we believe the FT825 represents an exciting new frontier in the field of cell-based cancer immunotherapy.

談到我們的實體瘤計劃，我也很高興地宣布，在我們與小野製藥的合作下，我們最近在使用該公司的 IPSC 產品平台設計的 FT825 第一階段研究中治療了第一位患者，我們相信 FT825 代表了基於細胞的癌症免疫治療領域一個令人興奮的新前沿。

For multiplexed engineered IPS derived CAR T cell program incorporates a constellation of synthetic anti-tumor mechanisms that are designed to harness the potential of both innate and adaptive immunity and to overcome the unique challenges in treating solid tumors.

對於多重工程 IPS 衍生的 CAR T 細胞程序，它結合了一系列合成抗腫瘤機制，旨在利用先天性和適應性免疫的潛力，並克服治療實體腫瘤的獨特挑戰。

These mechanisms include a CXCR2 receptor to promote cell trafficking, a Chimerix TGF-beta receptor to redirect immunosuppressive signals in the tumor microenvironment, a high-affinity non-cleavable CD16, a receptor to promote antibody-dependent cellular cytotoxicity, and a novel cancer specific HER2 targeted antigen binding domain, which has shown differentiated activity from that of trastuzumab in preclinical studies, including against HER2 low expressing tumor cells.

這些機制包括促進細胞運輸的 CXCR2 受體、重定向腫瘤微環境中免疫抑制信號的 Chimerix TGF-beta 受體、高親和力不可裂解的 CD16、促進抗體依賴性細胞毒性的受體，以及新型癌症特異性 HER2 靶向抗原結合域，該域在臨床前研究中表現出與曲妥珠單抗不同的活性，包括針對 HER2 低腫瘤細胞的活性。

The first patient in the Phase 1 study was diagnosed with HER2-positive, gastroesophageal junction adenocarcinoma had progressed after receiving multiple lines of treatment, including HER2 targeted therapies and was administered standard conditioning chemotherapy, followed by a single dose of FT825 as monotherapy at 100 million cells.

1 期研究中的第一位患者被診斷為 HER2 陽性，胃食道連接部腺癌，在接受包括 HER2 標靶治療在內的多線治療後病情出現進展，並接受了標準預處理化療，隨後以 1 億個細胞的單劑量 FT825 作為單一療法。

As we consider our strategic direction. We believe there is a strong value proposition for our iPSC product platform and off-the-shelf cell therapies in autoimmunity for patient safety, convenience and accessibility as well as cost and scale may be key differentiating factors.

當我們考慮我們的策略方向時。我們相信，我們的 iPSC 產品平台和現成的自身免疫細胞療法對於患者安全、便利性和可及性以及成本和規模具有強大的價值主張，可能是關鍵的差異化因素。

We believe our ADR technology can enable effective treatment with cell therapy without requiring administration of conditioning chemotherapy to patients, which has the potential to redefine the cell therapy treatment paradigm and patient experience for cancer and autoimmunity.

我們相信，我們的 ADR 技術可以實現細胞療法的有效治療，而無需對患者進行預處理化療，這有可能重新定義細胞療法治療癌症和自體免疫的治療模式和患者體驗。

And we believe our multiplexed engineered iPSC-derived CAR T-cell platform can deliver multiple synthetic mechanisms of anti-tumor activity with the potential to overcome unique challenges in treating solid tumors.

我們相信，我們的多重工程 iPSC 衍生 CAR T 細胞平台可以提供多種抗腫瘤活性合成機制，並有可能克服治療實體腫瘤的獨特挑戰。

As we look ahead into the second half of 2024, we are well positioned to reach and report on five key clinical milestones across our IPSC product pipeline for cancer and autoimmune diseases. Number one, we seek to demonstrate the disease transforming potential of FT819 in B-cell mediated autoimmune diseases. Specifically, we expect to read out initial Phase 1 clinical data for the first three to five patients treated with FT819 for moderate to severe SLE.

展望 2024 年下半年，我們已做好準備，在針對癌症和自體免疫疾病的 IPSC 產品線中實現並報告五個關鍵臨床里程碑。首先，我們力求證明 FT819 在 B 細胞介導的自體免疫疾病中的疾病轉化潛力。具體來說，我們期望讀出前三至五名接受 FT819 治療中度至重度 SLE 的患者的初步 1 期臨床數據。

Number two, we seek to administer FT819 without fludarabine, and instead with commonly used treatment regimens for autoimmune diseases. Specifically, we intend to amend the current IND for FT819 Phase 1 autoimmunity study to include administration with single agent Cytoxan and expect to read out initial patient clinical data.

第二，我們尋求在不使用氟達拉濱的情況下使用 FT819，而是使用常用的自體免疫疾病治療方案。具體來說，我們打算修改 FT819 第 1 階段自體免疫研究的當前 IND，以包括使用單一藥物 Cytoxan 進行給藥，並期望讀出初始患者臨床數據。

Number three, we seek to demonstrate the potential of our proprietary ADR technology to enable effective treatment of patients without administration of conditioning chemotherapy. Specifically, we expect to read out the first five no conditioning patients treated with 522 in our Phase 1 study for B-cell lymphoma.

第三，我們力求證明我們專有的 ADR 技術的潛力，即無需進行化療即可對患者進行有效治療。具體來說，我們預計將讀出我們針對 B 細胞淋巴瘤的第 1 階段研究中前五名未接受 522 治療的患者的情況。

Number four, we seek to broadly investigate 522 without conditioning chemotherapy for treatment of various B cell-mediated autoimmune diseases. Specifically, we expect to submit an IND application and subject to IND allowance by the FDA for initiate patient enrolment in a Phase 1 multi indication study of 522 for autoimmunity.

第四，我們尋求廣泛研究 522 無需預處理化療即可治療各種 B 細胞介導的自體免疫疾病。具體來說，我們預計將提交一份 IND 申請，並根據 FDA 的 IND 批准，啟動針對 522 名自體免疫疾病的第 1 階段多適應症研究的患者招募。

And finally, we seek to establish a new to show clinical proof of concept for our multiplexed engineered iPSC derived CAR T-cell platform in treating solid tumors. Specifically, we expect to read out the first three to five patients treated with FT825 in our Phase 1 study for advanced solid tumors.

最後，我們尋求建立一個新的臨床概念驗證，以證明我們的多重工程 iPSC 衍生的 CAR T 細胞平台在治療實體腫瘤方面的作用。具體來說，我們預計將在針對晚期實體瘤的第 1 期研究中讀出前三到五名接受 FT825 治療的患者。

I would now like to turn the call over to Ed to review our financial results for the first quarter.

現在我想將電話轉給 Ed，讓他回顧我們第一季的財務表現。

Thank you, Scott, and good afternoon. Fate Therapeutics is in a strong financial position to advance our pipeline of iPSC derived CAR T and CAR NK cell programs for autoimmune diseases and cancer. With the addition of net proceeds from the company's $80 million underwritten offering of common stock and $20 million concurrent private placement of pre-funded warrants in March.

謝謝你，斯科特，下午好。Fate Therapeutics 擁有雄厚的財務實力，可以推進我們用於治療自體免疫疾病和癌症的 iPSC 衍生的 CAR T 和 CAR NK 細胞計畫。加上該公司 3 月 8,000 萬美元承銷普通股和 2,000 萬美元同時私募預先出資認股權證的淨收益。

Our cash, cash equivalents and investments at the end of the first quarter were approximately $391 million. In the first quarter our reported revenue of $1.9 million was consistent with the prior two quarters and reflects the research funding associated with the development have a second product candidate against an undisclosed target in solid tumors under our collaboration with Ono Pharmaceuticals.

我們第一季末的現金、現金等價物和投資約為 3.91 億美元。我們第一季報告的收入為 190 萬美元，與前兩個季度持平，反映了與開發相關的研究資金，我們與小野製藥合作，針對實體腫瘤中未公開的目標開發了第二種候選產品。

As a reminder, after opting into a US and European co-development and co-commercialization arrangement with Ono for FT825 in the fourth quarter of 2022, we account for that program's reimbursable expenses as an offset within our research and development costs.

提醒一下，在 2022 年第四季選擇與小野公司就 FT825 達成美國和歐洲共同開發和共同商業化協議後，我們將該計劃的可報銷費用計入我們的研發成本中以抵銷。

We recognized $800,000 of contra R&D expense in the quarter. Research and development expenses for the first quarter were $32.1 million, essentially flat versus the fourth quarter of last year. Our expenditures in R&D were driven primarily by salaries and benefits, including share-based compensation and from clinical trial costs and demand for R&D materials.

我們在本季確認了 80 萬美元的研發費用抵銷。第一季研發費用為 3,210 萬美元，與去年第四季基本持平。我們的研發支出主要來自薪資和福利，包括股權激勵、臨床試驗成本和研發材料需求。

General and administrative expenses for the first quarter increased sequentially by 16% to $20.9 million. The increase in our G&A expenses was attributable primarily to increases in legal related fees.

第一季的一般及行政開支季增 16% 至 2,090 萬美元。我們的一般及行政費用增加主要歸因於法律相關費用的增加。

Total operating expenses for the first quarter increased by 7% relative to the fourth quarter of 2023 to $53 million which included $11 million in non-cash share-based compensation expense. Note that in connection with the development of our off-the-shelf IPSC derived CAR T cell product candidate, FT819 we previously achieved the clinical milestones set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which triggered a first milestone payment to MSK in 2021.

第一季總營運費用較 2023 年第四季成長 7%，達到 5,300 萬美元，其中包括 1,100 萬美元的非現金股權激勵費用。請注意，在開發我們的現成 IPSC 衍生的 CAR T 細胞候選產品 FT819 的過程中，我們之前已經實現了與紀念斯隆凱特琳癌症中心修訂的許可協議中規定的臨床里程碑，這引發了 2021 年向 MSK 支付的第一筆里程碑付款。

Up to two additional milestone payments may be owed to MSK based on subsequent trading values of the company's common stock ranging from $100 to $150 per share. We assess the fair value of these contingent milestone payments currently valued at $2.7 million on a quarterly basis.

根據公司普通股的後續交易價值，可能需要向 MSK 支付最多兩筆額外的里程碑付款，金額從每股 100 美元到 150 美元不等。我們按季度評估這些或有里程碑付款的公允價值，目前價值為 270 萬美元。

In the first quarter, we recorded a noncash $1.4 million non-operating loss associated with the change in fair value. Our net loss for the quarter was $48 million, or $0.47 per share. Finally, as we consider the investments we plan to make this year, we expect our GAAP operating expenses, which includes noncash items such as stock compensation expense and depreciation for the full year to be between $215 million and $230 million, and that we will end the year with more than $270 million in cash and cash equivalents and investments.

第一季度，我們記錄了與公允價值變動相關的 140 萬美元非現金非營業損失。本季我們的淨虧損為 4,800 萬美元，即每股 0.47 美元。最後，當我們考慮今年計劃進行的投資時，我們預計全年的 GAAP 營運費用（包括股票薪酬費用和折舊等非現金項目）將在 2.15 億美元至 2.3 億美元之間，並且我們將在年底擁有超過 2.7 億美元的現金和現金等價物和投資。

I would now like to open the call for questions.

現在我想開始提問。

(Operator Instructions)

（操作員指示）

Michael Yee, Jefferies.

麥可‧餘 (Michael Yee)，傑富瑞集團 (Jefferies)。

Thank you. We had a two-part question. Congrats on all the progress, Scott. on the autoimmune study that is enrolling, I know that was a bit slow to get off, but it sounds like you're going to have some good momentum and report patients.

謝謝。我們的問題分為兩部分。恭喜你所取得的所有進步，斯科特。關於正在招募的自身免疫研究，我知道進展有點慢，但聽起來你會有一些良好的動力並報告患者。

Can you just talk a little bit about how the plan to also allow single-agent Cytoxan would impact things and how you think about what that would show and how that would impact the design of the study.

您能否簡單談談允許單一藥物 Cytoxan 的計劃將如何影響事情，以及您認為這將顯示出什麼以及這將如何影響研究設計。

And then the second question is related to 522. I think it's exciting you're now in the second cohort without lymphodepletion. Can you just talk about the results that you might see there and how you would read through into what you see there into the idea for autoimmune as well? Thank you.

第二個問題與 522 有關。我覺得令人興奮的是，您現在已成為第二批沒有淋巴球減少的患者。您能否談談您可能會看到的結果以及您如何將所看到的內容融入自身免疫的想法中？謝謝。

Sure. So with autoimmunity -- in the autoimmunity study with FD819, the current study as designed has two different alternatives for conditioning. There is a standard three-day conditioning cycle of site flu, which is commonly used in the oncology setting. So I believe it's 500 milligrams per meter squared times three days for cyclophosphamide and 30 milligrams per meter squared at times three days fludarabine.

當然。因此，對於自體免疫——在 FD819 的自身免疫研究中，目前設計的研究有兩種不同的調理替代方案。現場流感有一個標準的三天調理週期，通常用於腫瘤學領域。所以我認為環磷醯胺的劑量是每平方公尺 500 毫克，持續三天；氟達拉濱的劑量是每平方公尺 30 毫克，持續三天。

We also have a second -- in the current study we also have a second conditioning regimen that is permitted. The second conditioning regimen is bendamustine based conditioning regimen, and that is that two day treatment regimen with bendamustine. While we're contemplating doing on and this is based on data we presented today, we believe we have good proof of concept in our FT819 oncology study.

我們還有第二種──在目前的研究中，我們還有第二種允許的調理方案。第二種調理方案是以苯達莫司汀為基礎的調理方案，即兩天的苯達莫司汀治療方案。雖然我們正在考慮繼續做下去，並且這是基於我們今天提供的數據，但我們相信我們在 FT819 腫瘤學研究中有很好的概念證明。

So this is the study in B-cell malignancies, where several of our patients in that study received bendamustine as a conditioning agent. So they did not receive cy/flu. They received a benda beased conditioning regimen in the oncology study. We presented the data on those patients specifically today, we saw very deep B-cell depletion in the periphery, which was maintained through the 30 day treatment cycle. And importantly, we saw clinical responses with the bendamustine treatment conditioning cycle or conditioning regimen.

這是一項針對 B 細胞惡性腫瘤的研究，其中我們的幾位患者接受了苯達莫司汀作為調理劑。所以他們沒有打流感疫苗。他們在腫瘤學研究中接受了 Benda 治療調理方案。我們今天特別展示了這些患者的數據，我們發現外周 B 細胞耗竭非常嚴重，而且這種狀況在 30 天的治療週期內一直持續。重要的是，我們看到了苯達莫司汀治療調理週期或調理方案的臨床反應。

So we did not use fludarabine, so in that regimen, we're not using fludarabine. So we saw activity with FT819 without fludarabine and so that gives us confidence that we can amend the IND to add on to a Cytoxan only regimen. We believe we can accomplish that efficiently through a amendment to the IND essentially adding a third quote unquote conditioning regimen for patients.

因此我們沒有使用氟達拉濱，所以在該方案中，我們不使用氟達拉濱。因此，我們看到了不使用氟達拉濱的 FT819 的活性，這讓我們有信心可以修改 IND 以添加到僅使用 Cytoxan 的方案中。我們相信，我們可以透過對 IND 進行修訂來有效地實現這一目標，本質上為患者增加了第三個所謂的調理方案。

And so the study would provide physician's choice of, cy/flu conditioning, bendamustine conditioning, or single agent cytoxan conditioning. And again, since cytoxan and bendamustine are in the same class of molecule. And given the activity we've seen in the oncology study, we feel confident in FT819 ability to perform in a cytoxan only regimen without fludarabine. Long answer, but I hope that was clear.

因此，該研究將為醫生提供環磷酰胺/流感調節、苯達莫司汀調節或單一藥物環磷酰胺調節的選擇。再一次，由於環磷醯胺和苯達莫司汀屬於同一類分子。鑑於我們在腫瘤學研究中看到的活性，我們對 FT819 在不含氟達拉濱的環磷酰胺單獨方案中發揮作用的能力充滿信心。答案很長，但我希望說得清楚。

Yeah, very, very nice. And then the read through from oncology because you're in the cohort B without conditioning?

是的，非常非常好。然後從腫瘤學角度解讀，因為你屬於沒有條件的 B 組？

Yeah. So with respect to 522, so with 522 obviously we have a long history with NK cells. We have started the study with cy/flu conditioning. It provides us the opportunity to do some direct comparison with 522 based on historical data sets that we have generated with FT596, our prior generation product.

是的。因此就 522 而言，顯然我們在 NK 細胞方面有著悠久的歷史。我們已經開始對 cy/flu 進行調節的研究。它為我們提供了機會，根據我們使用上一代產品 FT596 產生的歷史資料集，與 522 進行一些直接比較。

We presented data today where we believe in this early small numbers of patients obviously, we think we're seeing some differentiated activity with respect to persistence, which we're excited about. And so we are very excited now to essentially begin our clinical experiment with 522 or clinical experience with 522 with no conditioning.

我們今天展示的數據表明，我們相信，在早期少數患者中，我們看到了與持久性相關的一些差異化活動，我們對此感到興奮。因此，我們現在非常高興能夠開始使用 522 進行臨床實驗，或在沒有任​​何條件的情況下使用 522 進行臨床體驗。

Preclinically, and I'll let Bob talk about it, we've done a tremendous amount of work with 522 preclinically in our genetic systems, both using cancer cell lines as well as now using donor SLE cells and we presented the donor SLE, our preclinical data today.

在臨床前階段，我讓鮑伯來談談，我們在遺傳系統中對 522 進行了大量的臨床前工作，既使用了癌細胞系，也使用了供體 SLE 細胞，我們今天展示了供體 SLE，即我們的臨床前數據。

I'll let Bob talk about that because I think it does demonstrate the potential of 522 to essentially arise in an allogenic disease system.

我讓鮑伯來談論這個，因為我認為它確實證明了 522 在同種異體疾病系統中出現的潛力。

Thanks, Scott. So just to talk about preclinical and also answer some of your questions about how the clinical data will play out for autoimmune. So in the preclinically is, as Scott mentioned, having to ADR technology in 522 allows us to actually show activity in persistence, even when there is an intact PBMC compartment.

謝謝，斯科特。因此，我們只討論臨床前，並回答您關於臨床數據如何發揮作用的一些問題。因此，正如 Scott 所提到的，在臨床前階段，522 中的 ADR 技術使我們能夠真正顯示持久活性，即使存在完整的 PBMC 隔間。

So in a petri dish, we try to mimic what's happening in the patient setting by having the PBMCs and they're all different types of cells from PBMC. And we showed that with 522 we can actually show functional persistence. And this is very unique to the ADR technology because if you have NK cells without ADR or autologous CAR T, you won't get this observation.

因此，在培養皿中，我們嘗試透過使用 PBMC 來模擬患者環境中發生的情況，並且它們都是來自 PBMC 的不同類型的細胞。我們證明了，透過 522 我們實際上可以展示功能持久性。這對於 ADR 技術來說非常獨特，因為如果您擁有沒有 ADR 或自體 CAR T 的 NK 細胞，您將不會得到這種觀察。

And this observation very specific because we can coculture 522 with PBMCs and show that we can target because there's a CAR 19 and 522 B-cells in PBMC. However, we don't see an allo reaction that's induced by the T cell compartment. Even though these cells have an intact HLA expression on the surface, our product, we are able to hold off to allo reaction because we target from the positive population, which is the final stage of an activated cell.

這個觀察結果非常具體，因為我們可以將 522 與 PBMC 共培養，並表明我們可以進行標靶治療，因為 PBMC 中存在 CAR 19 和 522 B 細胞。然而，我們並沒有看到由 T 細胞區室誘發的同種異體反應。儘管這些細胞表面有完整的 HLA 表達，但我們的產品能夠抑制同種反應，因為我們的目標是陽性細胞群，這是活化細胞的最後階段。

So we are able to hold off on that and, we can maintain activity to functional persistence because when we rechallenge the 522 co culture with additional PBMCs, we can continue targeting the B-cell compartment and maintain functional persistence. This is not seen with auto CAR T this is not seen with NK cells.

因此，我們能夠推遲這種情況，並且可以保持活性以保持功能持久性，因為當我們用額外的 PBMCs 重新挑戰 522 共培養物時，我們可以繼續針對 B 細胞區室並保持功能持久性。這在自體 CAR T 和 NK 細胞中均未見過。

Moving to the clinical experience, I think one of the things that we're very excited about with our ability in translational under 522 without cy/flu on, we're going to be able to look at ctDNA and see how the disease is modulated with each dose of 522 in an intact and patient immune compartment and also look at the entire disease decrease over the treatment cycle. That's going to give us a hint of 522 activity without cy/flu conditioning.

談到臨床經驗，我認為，我們對在不聯合使用 cy/flu 的情況下使用 522 進行轉化的能力感到非常興奮，我們將能夠觀察 ctDNA 並了解在完整和患者的免疫區中，每次使用 522 治療時疾病是如何調節的，同時還可以觀察治療週期內整個疾病的減少情況。這將為我們提供無需 cy/flu 調節的 522 活動的提示。

We'll also look at the endogenous immune compartment and see how that's modulated and also look at the PK in an intact immune compartment with very sensitive assay. So we'll hopefully see a lot of activity there and be able to parlay that into autoimmune disease.

我們還將研究內源性免疫區室並了解其如何調節，同時也將透過非常敏感的分析研究完整免疫區室中的 PK。因此，我們希望看到那裡有很多活動，並能夠將其轉化為自體免疫疾病。

Yeah, perfect. Thank you, guys.

是的，完美。謝謝你們。

Thanks.

謝謝。

Yigal Nochomovitz, Citi.

花旗銀行的 Yigal Nochomovitz。

Hi, team this is Ashiq, on for Yigal. Thank you for taking our questions. We had a couple. First on FT819, you mentioned patient case studies have shown secondary and tertiary tissue trafficking and infiltration. Are you doing tissue biopsies here?

大家好，我是 Ashiq，代表 Yigal 參賽。感謝您回答我們的問題。我們有一對夫婦。首先在 FT819 上，您提到患者案例研究顯示了二級和三級組織運輸和浸潤。您在這裡做組織切片嗎？

No, Ashiq, so we do show a primary, secondary and tertiary activity. For the primary, we show that we have a persistence in the bone marrow and that correlates with reduction and elimination of CLL positive cells and this is based on flow cytometry. So we show on the persistence and infiltration of the bone marrow and clearance of disease.

不，Ashiq，所以我們確實展示了主要、次要和第三級活動。對於原發性腫瘤，我們表明它在骨髓中具有持久性，並且與 CLL 陽性細胞的減少和消除有關，這是基於流式細胞儀的。因此我們展示了骨髓的持續性和浸潤以及疾病的清除。

In our secondary for the lymphoid, we have biopsy lymphoid tissues. We have biopsies there and we can show that the population is reduced. And for tertiary, the example we used in our presentation is liver and PEDS Score which correlates to PK.

在我們的二級淋巴系統中，我們有活檢淋巴組織。我們在那裡進行了活檢，可以證明人口減少了。對於第三級，我們在演示中使用的例子是肝臟和 PEDS 評分與 PK 相關。

So we're able to -- through different methods where there is direct detection of cells or proxy detection of cells, be able to show that we are able to have activity in was primary secondary and tertiary tissues.

因此，我們能夠——透過直接檢測細胞或代理人檢測細胞的不同方法，能夠證明我們能夠在原發性、次級和三級組織中進行活動。

Okay, great. That makes sense. And then a second question is more of a general question. Given you're planning to file an IND for FT522 for autoimmune. How should we think about expectations on the efficacy here. Are you hoping to see efficacy on par with CAR-Ts or is that the main focus is more like removing or lowering the preconditioning burden maybe little bit of a cost on efficacy.

好的，太好了。這很有道理。第二個問題比較像是一般性問題。假設您計劃為 FT522 提交用於治療自體免疫的 IND。我們應該如何看待這裡的功效預期。您是否希望看到與 CAR-T 相當的療效，或者主要重點是消除或降低預處理負擔，可能會對療效產生一點影響。

Yeah, I think as we're going into this study, we acknowledge efficacy is really important. I think at the end of the day, what's been really exciting about cell therapy here in autoimmunity is the fact that, again, this is coming out of the German study, a single dose of CAR T-cell therapy has been able to generate an immune reset in patients that have had disease and refractory disease for a significant period of time, and that's been quite remarkable.

是的，我認為當我們進行這項研究時，我們承認功效非常重要。我認為，歸根結底，細胞療法在自身免疫領域真正令人興奮的是，同樣，這是來自德國的研究成果，單劑量 CAR T 細胞療法已經能夠在患病和患有相當長一段時間的難治性疾病的患者中產生免疫重置，這是非常了不起的。

And I think folks are very excited about that. I think with respect to autoimmunity efficacy is certainly going to be important and we need to acknowledge that at some basic level, we need to be able to compete on efficacy.

我認為大家對此感到非常興奮。我認為就自體免疫而言，功效肯定非常重要，我們需要承認，在某些基本層面上，我們需要能夠在功效上競爭。

That said autoimmunity is a very different setting than oncology, and I think safety is certainly going to be at a premium with respect to autoimmunity. I think one of the challenges that has already confronted the field is that cy/flu conditioning may not be well accepted by patients in the field of autoimmunity. And so I think safety is going to be critical, I think alternative regimens where you can add on to standard of care treatments is going to be critical.

也就是說，自體免疫與腫瘤學是非常不同的，我認為對於自體免疫而言，安全性肯定是最重要的。我認為該領域已經面臨的挑戰之一是，cy/flu 調節可能不會被自體免疫領域的患者很好地接受。因此我認為安全至關重要，我認為可以添加到標準護理治療中的替代療法至關重要。

I think reaching patients where they live and breathe, which is not at the academic CAR T-cell centers is going to be critical. And so I think there are a multitude of elements here that are going to be important in autoimmunity that are different than oncology. And I do think an off-the-shelf cell therapy has significant sort of a attribute that can be very appealing for these patients.

我認為，讓患者能夠接觸到他們生活和呼吸的地方（而不是學術性的 CAR T 細胞中心）至關重要。因此，我認為這裡有許多元素對於自體免疫學來說都很重要，與腫瘤學不同。我確實認為現成的細胞療法具有顯著的特性，對這些患者來說非常有吸引力。

Okay. Got it, great. Thank you very much for taking our questions.

好的。明白了，太好了。非常感謝您回答我們的問題。

Daina Graybosch, Leerink Partners.

Daina Graybosch，Leerink Partners。

So this is Jeff on for Daina. So we have a few questions, and the first was around competitive landscape. There are some recently published encouraging data with the first-gen CD19 by blinatumomab. What was your view that data and how you're thinking about T-cell engager competition overall for autoimmune disease, given that the modality addresses many of the same challenges of auto CAR T that your off-the-shelf program do.

這是傑夫 (Jeff) 代替戴娜 (Daina)。所以我們有幾個問題，第一個是關於競爭格局。最近發布了有關第一代 CD19 blinatumomab 的一些令人鼓舞的數據。鑑於該療法解決了與您們的現成方案相同的許多自體 CAR-T 挑戰，您對這些數據有何看法？您如何看待 T 細胞接合劑在自體免疫疾病中的整體競爭？

And then looking at kind of BCMA and your plans for a next-gen program there, do you expect to use the ADR modality there. And is that sufficient or are you looking at other edits. And what do you think BCMA as that you wouldn't already achieved with your CD19 program? Thank you.

然後看看 BCMA 的類型以及您在那裡的下一代計劃，您是否希望在那裡使用 ADR 模式。這是否足夠了，或者您正在查看其他編輯。您認為 BCMA 透過 CD19 計畫還無法實現什麼目標？謝謝。

Yeah, so on your sort of general question around CD19 engagers, I think we're approaching the autoimmunity space eyes wide open with respect to the -- disruptive potential of CD19 engagers. And ultimately, as we're thinking about further development of the autoimmunity space, we recognize the benefits that can be brought to patients potentially in differentiating potential of the CD19 engager.

是的，關於您關於 CD19 接合器的一般性問題，我認為我們正在睜大眼睛看待自體免疫領域，考慮到 CD19 接合器的破壞潛力。最終，當我們考慮進一步發展自體免疫領域時，我們認識到 CD19 接合器的區分潛力可能為患者帶來的好處。

We've obviously seen that play out in oncology. And as we think about it, we are thinking about essentially our target product profile. I'm going directly up against what the value proposition of the T-cell engager. And hence, that's how you will hear us obviously talk about and we've talked about are on the call today how important we think it is too move away from cy/flu to add on to standard of care treatments to reach patients in the community setting to minimize hospitalization and to prioritize safety and efficacy.

我們顯然已經看到這種情況在腫瘤學中發生。當我們思考這個問題時，我們基本上是在思考我們的目標產品概況。我將直接反對 T 細胞接合器的價值主張。因此，這就是您顯然會聽到我們談論的內容，而且我們在今天的電話會議上也談論過，我們認為擺脫 cy/flu 以增加標準護理治療以覆蓋社區環境中的患者以盡量減少住院治療並優先考慮安全性和有效性的重要性。

So I think we're going into this recognizing that T-cell engagers will play an important role in treating patients with autoimmunity and developing target product profiles directly head to head against those. As it relates to BCMA, I think just generally and this is not a comment specifically to BCMA, but I think we're very excited about the ADR technology, both with respect to its first assessment with five to two clinically.

因此，我認為我們要認識到，T 細胞接合劑將在治療自體免疫患者和開發針對這些患者的目標產品方面發揮重要作用。就 BCMA 而言，我認為這只是一般性問題，這並不是專門針對 BCMA 的評論，但我認為我們對 ADR 技術感到非常興奮，無論是就其首次臨床評估而言，還是就其 5 比 2 而言。

But I think, I'll let Bob talk to it, and correct me if I'm wrong, but I think any product candidate you're going to see emerge from Fate Therapeutics from this point forward will incorporate on ADR technology. We absolutely believe that conditioning chemotherapy, intense chemotherapy -- conditioning chemotherapy is a headwind for the field of cell therapy, and we need to move beyond that.

但我想，我會讓鮑伯談論它，如果我錯了，他會糾正我，但我認為從現在開始你將看到的任何來自 Fate Therapeutics 的產品候選都會融入 ADR 技術。我們堅信，預處理化療、強化化療──預處理化療是細胞治療領域的阻力，我們需要超越它。

And we're excited to do that we're excited to pioneer that and we think we've put a tremendous amount of work, both respect to research and innovation on how to achieve a new cell therapy treatment paradigm with off-the-shelf therapy.

我們很高興能夠做到這一點，我們很高興能夠開創這一領域，我們認為我們已經投入了大量的工作，包括研究和創新，以利用現成的療法實現新的細胞療法治療模式。

Great. Thank you. Actually, just a quick follow-up in the mitigating lymphodepletion. How does bendamustine only compare to cyclophosphamide only in terms of relative potency. And would you expect the same degree of in our CAR T FT819 expansion in vivo and the same level of potency as you kind of saw with bendamustine examples? Thank you.

偉大的。謝謝。實際上，這只是緩解淋巴球減少症的快速後續措施。苯達莫司汀在相對效力方面與環磷酰胺相比如何？您是否期望我們的 CAR T FT819 體內擴增達到與您在苯達莫司汀示例中看到的相同程度，並且具有相同的效力水平？謝謝。

Yes, I think it's first, there's some data on this, right. There's some data out there that certainly combines in the field of oncology and CAR T-cell therapy that has done work comparing cy/flu conditioning to bendamustine. And I think on generally speaking, it's been demonstrated that bendamustine can be an effective alternative treatment conditioning regimen for CAR T-cell therapy.

是的，我認為這是首先，有一些關於這方面的數據，對。有一些數據肯定結合了腫瘤學和 CAR T 細胞療法領域，對 cy/flu 調節和苯達莫司汀進行了比較。我認為，總體而言，已經證明苯達莫司汀可以作為 CAR T 細胞療法的有效替代治療調理方案。

Bendamustine is in the same chemical class as cyclophosphamide. We do have experience, as I mentioned, with bendamustine as a standalone conditioning agent without fludarabine. And so we're fairly confident that our programs can achieve FT819 perform with cyclophosphamide.

苯達莫司汀與環磷醯胺屬於同一化學類。正如我所提到的，我們確實有使用苯達莫司汀作為不與氟達拉濱一起使用的獨立調理劑的經驗。因此，我們非常有信心，我們的程序可以透過環磷酰胺實現 FT819 的性能。

Great. Thanks for taking my questions.

偉大的。感謝您回答我的問題。

Mike Ulz, Morgan Stanley.

摩根士丹利的麥克烏爾茲。

Hi, this is Robert on for Mike. Thanks for taking our questions. Can you just talk about what you've seen with the first lupus patient treated with FT819. And how safety compares to what's been seen in the autologous CD19 therapies. And then can you also talk about what other autoimmune diseases you would consider expanding to? Thank you.

大家好，我是羅伯特，代表麥克。感謝您回答我們的問題。您能否談談您對第一位接受 FT819 治療的狼瘡患者所觀察到的情況？與自體 CD19 療法相比，其安全性如何。然後您還能談談您考慮擴展到哪些其他自體免疫疾病嗎？謝謝。

Yeah, I think I'll limit my comments to what we disclosed to date. The patient is still in the first of these patients still is in the 30 day DLT assessment window. I can absolutely say that patients was discharged after three days of hospitalization. So it was a three-day hospitalization stay it was on eventful and there were no notable adverse events.

是的，我想我會將我的評論限制在我們迄今為止所披露的內容範圍內。該患者仍處於這些患者中的第一位，仍處於 30 天 DLT 評估窗口內。我可以肯定的說，病人住院三天後就出院了。因此，這是為期三天的住院治療，期間發生了很多事，沒有發生明顯的不良事件。

Patient does still remain though in the 30 day DLT assessment window. With respect to expansion into other indications in autoimmunity, we are doing a fair bit of work assessing that opportunity. Obviously, one of the elements of assessment is looking where others have established.

但患者仍處於 30 天的 DLT 評估窗口內。關於擴展到自體免疫的其他適應症，我們正在做大量工作來評估這個機會。顯然，評估的要素之一是考察其他人已經建立的地方。

And this is primarily coming out of the German study, but also in the field of allogeneic stem cell transplant. looking at where other B-cell there's been success with other B-cell mediated diseases with either transplant or out of the German group in the early seminal data sets. I'll leave it at that.

這主要源自德國的研究，也涉及異體幹細胞移植領域。查看早期精液資料集中其他 B 細胞透過移植或德國組以外的方法成功治療其他 B 細胞介導的疾病的情況。我就不多說了。

Thank you.

謝謝。

Li Watsek, Cantor Fitzgerald.

李沃特塞克，康托費茲傑拉。

Hey, good afternoon. Thanks for taking the questions. Maybe just follow up on what other indications that you might go into this is for 522. And as far you mentioned that you're looking at multiple autoimmune diseases.

嘿，下午好。感謝您回答這些問題。也許只是跟進一下還有哪些其他跡象表明您可能會進入 522 階段。正如您所提到的，您正在研究多種自體免疫疾病。

So just wondering since it's quite crowded in the multi space. So just wondering what are other indications that you might be considering such as RA and how do you think about 522 sitting with 819 in terms of which patient -- which types of patients do go after.

所以只是好奇，因為多空間裡相當擁擠。所以我只是想知道您可能正在考慮的其他跡像是什麼，例如 RA，以及您如何看待 522 與 819 放在一起，對於哪類患者——哪些類型的患者需要治療。

So at this point, we are doing a lot of work not going to disclose our strategy at this point in time, we are obviously doing a lot of work in thinking about our expansion strategy in autoimmunity. We are looking at areas where there has been clinical precedent with cell therapies, whether that be in transplant or out of the first data sets that are being generated both out of Germany as well as the initial sort of company initiatives or company program. So not prepared to disclose today how we think about expanding our FT819 IND into additional indications or the initial multi-indication study that we plan to submit for 522.

因此，目前我們正在做大量工作，但目前不會透露我們的策略，我們顯然正在做大量工作來思考我們在自身免疫方面的擴張策略。我們正在研究細胞療法已有臨床先例的領域，無論是移植還是德國產生的首批數據集以及最初的公司舉措或公司計劃。因此，今天我們還沒有準備好披露我們如何考慮將 FT819 IND 擴展到其他適應症，或者我們計劃為 522 提交的初始多適應症研究。

Okay. And then maybe just wondering if you can just comment on your expectation for the patient enrolment in 819 study it seems like, you can dose the patients fairly quickly. And then it seems like you're going to amend the protocol to allow some alternative condition regimen. So do you think that might drive sort of the traction with the site investigators?

好的。然後也許只是想知道您是否可以評論一下您對 819 項研究中患者入組的期望，看起來您可以相當快地給患者服藥。然後看起來你要修改協議以允許一些替代條件方案。那麼，您認為這可能會對現場調查人員產生一定的影響嗎？

Yeah, we -- so specifically, we have guided to three to five patients -- an update on three to five patients in 819 study by the end of this year. We've also guided to and we've discussed on the call that we are looking to utilize Cytoxan only as a third potential regimen for treating patients. So cy/flu or benda or Cytoxan only.

是的，我們 — — 具體來說，我們已經指導了三到五名患者 — — 在今年年底前對 819 項研究中的三到五名患者進行了更新。我們也在電話會議上進行了指導和討論，我們希望僅將 Cytoxan 用作治療患者的第三種潛在方案。因此僅限 cy/flu 或 benda 或 Cytoxan。

We do think that and I think there's been discussion about this, that cy/flu potentially is a barrier to treating patients with autoimmunity. These patients aren't oncology patients they don't deserve to be treated like oncology patients. And so I do think moving away from cy/flu as a conditioning regimen is going to be critical to really capturing the potential of cell therapy and autoimmunity and look to pioneer that.

我們確實認為，而且我認為已經有人討論過這個問題，即環丙沙星/流感可能是治療自體免疫患者的障礙。這些病人不是腫瘤病人，不應該被當成腫瘤病人。因此，我確實認為，擺脫 cy/flu 作為調理方案對於真正發揮細胞療法和自體免疫的潛力至關重要，並期待開創這一先河。

Thank you.

謝謝。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（Tara Bancroft），TD Cowen。

Hi there. This is Greg speaking on behalf of Tara, I'm wondering if you can give us any timeline for when we can expect clinical data in lupus for 819.

你好呀。我是 Greg，代表 Tara 發言，我想知道您是否可以告訴我們何時可以獲得 819 狼瘡臨床數據的時間表。

So in the prepared remarks, we've guided to an update on the first three to five patients with FT819 in SLE by the end of this year.

因此，在準備好的評論中，我們指導了今年年底前對前三到五名患有 SLE 的 FT819 患者進行更新。

Okay, great. Thank you.

好的，太好了。謝謝。

Ben Burnett, Stifel.

本·伯內特（Ben Burnett），Stifel。

Hi, this is Carolina Ventoso on for Ben Burnett. Thank you for taking our question and congratulations on all your progress. On the ex vivo data for FT819 on the pretreatment sample from the SLE patients. What do the ET ratios shown imply about the necessary dose and cell expansion that we would need to achieve to get that deep B-cell depletion at the end of the CAR in vivo in SLE patients?

大家好，我是 Carolina Ventoso，為 Ben Burnett 播報。感謝您回答我們的問題，並祝賀您所取得的所有進步。關於 SLE 患者治療前樣本中 FT819 的體外數據。所示的 ET 比率暗示了我們需要達到什麼樣的劑量和細胞擴增才能在 SLE 患者體內 CAR 結束時實現深度 B 細胞耗竭？

I'm happy to answer that question and I'll use some math here so please forgive me if I start getting a little hypothetical. But so what we show in the data is that at 2:1 ET ratio, we effectively eliminated all B-cells that were in the PBMC compartment from the patient.

我很樂意回答這個問題，我會在這裡使用一些數學知識，所以如果我開始有點假設，請原諒我。但我們在數據中顯示的是，在 2:1 的 ET 比例下，我們有效地消除了患者 PBMC 區室中的所有 B 細胞。

If you were to think about the disease burden in R&D units, specifically SLE, we anticipate somewhere around 100 million to 300 million disease B-cells residing within a patient. So if we're effectively clearing around almost all cells at 2:1, but pretty much over 95% at 1:1.

如果您考慮研發部門的疾病負擔，特別是 SLE，我們預期患者體內約有 1 億到 3 億個疾病 B 細胞。因此，如果我們以 2:1 的比例有效清除幾乎所有細胞，但以 1:1 的比例清除超過 95% 的細胞。

Our current dose at [360 million falls right smack in the middle of an effective dose that we see in vitro. So to answer your question specifically, we are eliminating all T-cells at 2:1 and over 90% at 1:1. And that should give us confidence that the current dose is basically on par to match that. And the patient sitting at 360 million]

我們目前的劑量[3.6 億正好處於我們在體外觀察到的有效劑量的中間。因此，具體回答您的問題，我們以 2:1 的比例消除所有 T 細胞，以 1:1 的比例消除 90% 以上的 T 細胞。這應該讓我們有信心，目前的劑量基本上與此相當。而病人則坐在3.6億]

Okay. Pretty helpful. Thank you.

好的。非常有幫助。謝謝。

Peter Lawson, Barclays.

巴克萊銀行的彼得·勞森。

Hi, this is Alex on for Peter. Thank you for taking the question. Just wondering if you maybe just recap the data a little bit, the ASGCT data, when you look at the preclinical and translational data for 819 versus 522, so the CAR program versus the NK cell program. Any notable differences you see in terms tissue distribution, B-cell depletion are B-cell reconstitution?

大家好，我是 Alex，代表 Peter。感謝您回答這個問題。我只是想知道，當您查看 819 與 522 的臨床前和轉化數據時，您是否可以稍微回顧一下數據，ASGCT 數據，因此 CAR 計劃與 NK 細胞計劃。您在組織分佈、B 細胞耗竭和 B 細胞重建方面看到任何顯著差異嗎？

Sure, I can answer that question. So FT819 and FT522, obviously are very different FT522 not only has the ADR technology, but also the IL-15 receptor fusion. So preclinically, we see a very good biodistribution with FT522 because it's very much doesn't need antigen for expansion, doesn't need cytokine for expansion. So we see very good biodistribution, obviously, it has the ability to be combined with a monoclonal antibody.

當然，我可以回答這個問題。所以FT819和FT522顯然有很大的不同FT522不僅具有ADR技術，而且具有IL-15受體融合。因此，在臨床前階段，我們看到 FT522 具有非常好的生物分佈，因為它不需要抗原來擴增，也不需要細胞激素來擴增。因此我們看到了非常好的生物分佈，顯然它具有與單株抗體結合的能力。

So we see that as well either we enhanced activity against a specific cell, like, for example, targeting CD19 and CD20 at the same time or going after other cell types that have eliminated the CD19 expression and only expressing, for example, CD38. So that multi-antigen perspective, also content through with FT522 but FT819 having the 1XX CAR and the track locus is a very potent CAR product.

因此，我們也看到，我們要麼增強針對特定細胞的活性，例如同時針對 CD19 和 CD20，要麼追蹤消除了 CD19 表達並僅表達 CD38 等的其他細胞類型。因此，從多抗原角度來看，FT522 也滿足，但具有 1XX CAR 和軌道基因座的 FT819 是一種非常有效的 CAR 產物。

And so we see that when we go head to head against auto CAR T in on preclinical studies. So we see very potent activity with FT819, as I mentioned earlier as well. So those are the main differences in terms of behavior of the cells. We have a product that's ADR that designee conditioning and can go multi-antigen targeting and another product is very potent against CD19.

因此，當我們在臨床前研究中與自體 CAR-T 展開正面交鋒時，我們看到了這一點。因此，我們看到 FT819 具有非常強大的活性，正如我之前提到的。這些就是細胞行為的主要差異。我們有一種 ADR 產品，可以進行指定調理並進行多抗原標靶治療，另一種產品對 CD19 非常有效。

And I think one of the comments I would just add onto that is FT819 with respect to its manufactured phenotype has high expression of CXCR4. And so we've seen very good sort of homing and trafficking and infiltration of secondary and tertiary tissue in preclinical studies.

我想補充的一點是，就其製造的表型而言，FT819 具有較高的 CXCR4 表達。因此，我們在臨床前研究中看到了非常好的歸巢、運輸和二級和三級組織的滲透。

That's a good point.

這是一個很好的觀點。

Okay, thank you. And I guess does that have any applications for which type of indications you could target in the autoimmune setting? Thank you.

好的，謝謝。我想這是否對於在自體免疫環境中可以針對哪種類型的適應症有任何應用？謝謝。

Yeah, I mean it's something we're looking at. I mean, we are still doing work on thinking about exactly how to expand and what indications are going to be prioritized with 819 and 522. We are prepared and now we are preparing to expand the 819 IND to consider additional indications. And obviously, we've discussed filing a multi-indication for IND for 522. So a lot of work going on to stay tuned there on that front.

是的，我的意思是這是我們正在研究的事情。我的意思是，我們仍在思考如何擴展以及 819 和 522 將優先考慮哪些適應症。我們已經做好準備，現在正準備擴大819 IND以考慮其他適應症。顯然，我們已經討論過為 522 提交多適應症 IND。因此，我們在這方面還有很多工作要做。

Yanan Zhu, Wells Fargo Securities.

朱亞南，富國證券。

Great. Thanks for taking our questions. To follow up on a prior question about the bispecific literature, recent literature. Just wondering, do you have a view on the depth of B-cell depletion, a bispecific antibody can achieve competitive with cellular therapy. And do you foresee for the bispecs if it becomes a modality, would it be repeat administration at certain time interval, could that be viable competitive with cellular therapy?

偉大的。感謝您回答我們的問題。為了跟進有關雙特異性文獻、最新文獻的先前問題。只是想知道，您對 B 細胞耗竭的深度有何看法，雙特異性抗體能否與細胞療法競爭。您是否預見到，如果 Bispec 成為一種治療方式，它是否會在一定的時間間隔內重複給藥，這是否能夠與細胞療法競爭？

And lastly for 819, do you foresee the potential possibility of additional doses at a certain time interval and whether that could be part of the product profile and what you might even be considering looking at in a current study? Thanks.

最後，對於 819，您是否預見到在一定時間間隔內增加劑量的潛在可能性，以及這是否可以成為產品概況的一部分，以及您是否可能考慮在當前研究中研究這一點？謝謝。

So forgive me, I am not an expert on the bispecific engagers, and so I can't talk in an informative way about the depth of B-cell depletion that's been at on scene or achieved with the B-cell engagers. Obviously, in the setting of oncology, the T-cell engagers have generated complete responses.

所以請原諒我，我不是雙特異性接合器的專家，因此我無法以資訊豐富的方式談論現場出現的或使用 B 細胞接合器實現的 B 細胞耗竭的深度。顯然，在腫瘤學領域，T 細胞接合器已經產生了完全的反應。

So again, we are going into the field of autoimmunity, recognizing that T-cell engagers can be a attractive modality and have the potential to drive an immune reset. Whether that's achievable, what the duration of that looks like with the side-effect of profile that looks like how many doses all that's TBD we're very early, I think just generally in the field of autoimmunity.

因此，我們再次進入自體免疫領域，認識到 T 細胞接合劑可能是一種有吸引力的治療方式，並有可能推動免疫重置。這是否可以實現，其持續時間如何，副作用如何，例如需要多少劑量，這些都還有待確定，我們還處於早期階段，我認為一般來說只是在自身免疫領域。

That said I think one of the potential strengths of an engager is that it can be multi-dose. And I do think from our standpoint, we as a company, we've always discussed the fact that an off-the-shelf cell therapy we do think has multi dosing potential.

話雖如此，我認為參與器的潛在優勢之一是它可以是多劑量的。我確實認為，從我們的角度來看，作為一家公司，我們一直在討論這樣一個事實：現成的細胞療法確實具有多劑量潛力。

I think multi-dosing potential can be hindered by cy/flu conditioning. Hence, as we've discussed, we think it's important to think about of 819 and 522 being developed as add on strategies. Two standard regimens that are used today to treat patients in the community setting with autoimmune disease. And I think you will see us continue to move in that direction where we are thinking about delivering and dosing cell therapies as if they were a monoclonal antibody.

我認為 cy/flu 調節可能會阻礙多次給藥的潛力。因此，正如我們所討論的，我們認為將 819 和 522 作為附加策略進行開發非常重要。目前用於治療社區中自體免疫疾病患者的兩種標準方案。我想你會看到我們繼續朝著這個方向前進，我們正在考慮將細胞療法像單株抗體一樣進行遞送和給藥。

Got it. Very helpful. Thank you.

知道了。非常有幫助。謝謝。

Bill Maughan, Canaccord Genuity.

Canaccord Genuity 的 Bill Maughan。

Hi, thanks for taking the question. So follow-up on this morning's 819 data. All the PK, obviously was positive. But thinking about translating that from an oncology patient to an autoimmune patient when antigen dependent expansion is a key part of the PK of a CAR T-cell therapy. I'm just wondering how you think about being able to translate from one population to the next.

你好，謝謝你回答這個問題。因此請關註今天上午的 819 數據。一切PK，顯然都是正面的。但是，當抗原依賴性擴增是 CAR T 細胞療法 PK 的關鍵部分時，請考慮將其從腫瘤患者轉化為自體免疫患者。我只是想知道您如何看待從一個群體轉化到另一個群體的能力。

I think there's a lot we don't know with respect to how the two diseases are going to translate. I think on what we have certainly seen with the PK is that we have seen CD19 mediated expansion that is dose dependent. Certainly, the mechanism of action or one of the key mechanisms of action in autoimmunity is being able to recognize and target and eliminate CD19 positive B-cells.

我認為，對於這兩種疾病將如何相互轉化，我們還有很多不了解的地方。我認為我們在 PK 中確實看到的是，我們看到了劑量依賴性的 CD19 介導的擴增。當然，自體免疫的作用機製或關鍵作用機制之一是能夠識別、瞄準和消除 CD19 陽性 B 細胞。

So I don't necessarily presume that actually the PK profiles are necessarily going to be the same in oncology versus autoimmunity. I think at the end of the day, what's obviously critical is on the kinetics and depth of B-cell depletion.

因此，我並不一定認為腫瘤學和自體免疫學中的 PK 特徵實際上必然相同。我認為，歸根結底，至關重要的顯然是 B 細胞耗竭的動力學和深度。

Thank you.

謝謝。

Ethan Markowski, Needham & Company.

伊森‧馬科夫斯基，李約瑟公司。

Yeah, hi. This is Ethan on for Gil Blum. Thank you for taking our question. So I'm just looking at the chart from ASGCT data, and I think you guys clearly show that at FT522 demonstrate deeper B-cell depletion than FT596.

是的，你好。這是 Ethan 代替 Gil Blum 上場。感謝您回答我們的問題。所以我只是看了 ASGCT 數據的圖表，我認為你們清楚地表明了 FT522 比 FT596 表現出更深的 B 細胞耗竭。

But it looks like FT819 graph at least the bar graph and depletion is very similar to FT596 with themselves kind of coming back up in the mid-teens end of the cycle. I was wondering, first, how important this complete responses and if some cells coming back at the end is clinically relevant.

但看起來 FT819 圖表至少長條圖和消耗與 FT596 非常相似，它們在週期的十幾歲末期都會重新上升。首先，我想知道這種完整的反應有多重要，以及最後一些細胞的恢復是否具有臨床意義。

And then also just from a cost savings perspective, I know you're no longer planning to move forward in multiple myeloma and B-cell lymphoma. So wondering if that has any impact in a positive way on near term R&D spend. Thank you for taking the question.

而且僅從節省成本的角度來看，我知道您不再計劃繼續治療多發性骨髓瘤和 B 細胞淋巴瘤。所以想知道這是否會對近期的研發支出產生正面影響。感謝您回答這個問題。

Yeah, so on a last question with respect to clinical development in multiple myeloma, obviously there are patient costs associated with clinical development. We are -- while we are not advancing 576 into dose expansion, we are seeing multiple myeloma.

是的，關於多發性骨髓瘤臨床開發的最後一個問題，顯然臨床開發涉及患者費用。雖然我們沒有推進 576 的劑量擴展，但我們正在觀察多發性骨髓瘤。

We are certainly expanding development in autoimmunity. And so in terms of changing cash burn, I don't think we're thinking about that as enhancing our savings or reducing on, we're certainly investing in a lot. And as it relates to B-cell depletion, I think keep in mind with those 819 as well as 522, we are seeing very, very low levels of cells in any instances, and I'll let Bob talk about it, but lower limit of sort of detection.

我們確實正在擴大自體免疫方面的發展。因此，就改變現金消耗而言，我認為我們並沒有考慮增加儲蓄或減少儲蓄，我們肯定會投入大量資金。至於它與 B 細胞耗竭有關，我認為請記住 819 和 522，在任何情況下我們都會看到非常非常低的細胞水平，我會讓鮑勃談論它，但這是檢測的下限。

And so when we start getting into very, very low levels, you start to get into sort of can you have a discussion about whether it is or significant or not. And I don't believe that at least we think that we're seeing different levels of depletion with a 819 versus 522. I'll let Bob comment on that.

因此，當我們開始進入非常非常低的水平時，您就會開始討論它是否重要。我不相信至少我們認為我們看到了 819 和 522 的不同程度的消耗。我會讓鮑伯對此發表評論。

I will say, just to be really clear, 522 -- FT819 data set is over a much larger data set of patients. I think we used 23 patients with B-cell lymphoma for that data set. Some of those patients had relatively high B-cell counts going into the study.

我要說的是，為了真正清楚起見，522 - FT819 資料集是一個更大的患者資料集。我認為我們使用了 23 名 B 細胞淋巴瘤患者作為該資料集。其中一些患者在研究開始時 B 細胞計數相對較高。

In fact, we noted that there were certain patients that had super physiological levels of B-cell counts that we were able to deplete with FT819. The 522 data set is, I think, only on two patients and their B-cell counts generally were lower on at baseline compared to the totality of the 819 patients?

事實上，我們注意到某些患者的 B 細胞數超出生理水平，我們可以透過 FT819 將其清除。我認為，522 個數據集僅涉及兩名患者，與 819 名患者的總體相比，他們的 B 細胞計數在基線時通常較低？

I'll let Bob talk to you on that. But I think generally speaking what we're seeing with respect to B-cell reconstitution from the shed data as B-cell reconstitution actually can happen as for instance, early as the third or fourth week and can happen as late as four months. But I'll let Bob sort of finish up on that if I missed anything.

我會讓鮑伯和你談談這件事。但我認為一般來說，從脫落數據中我們看到的 B 細胞重建情況是，B 細胞重建實際上可以在例如第三或第四週發生，最晚可以在四個月發生。但如果我遺漏了什麼，我會讓鮑伯來完成。

No, I think you've covered it. When discussing 819 as Scott mentioned, there was a large number of patients, but it felt pretty much in line with showing very good B-cell depletion over the treatment cycle. And B-cell recovery was seen and some of the patients. Now keep in mind, this is oncology so what's coming back up could be a lymphoma cell or something so.

不，我想你已經講完了。正如斯科特所提到的，在討論 819 時，患者數量眾多，但感覺與治療週期內表現出非常好的 B 細胞耗竭非常一致。部分患者的 B 細胞已恢復。現在請記住，這是腫瘤學，所以再次出現的可能是淋巴瘤細胞或類似的東西。

We're in a much more aggressive stage than what shed showed, but as Scott mentioned shed showed, is that B-cells do come back from 30 days to 180 days. So every patient treated all 15 sheds data had, I believe, day 180 full recovery of B-cells. So 819 is very much in line with shed show now with 522, we're bring up a very good point.

我們正處於比她所展示的更具侵略性的階段，但正如斯科特所提到的，她所展示的是，B 細胞確實會在 30 天到 180 天內恢復。因此，我相信，接受全部 15 次治療的患者在第 180 天 B 細胞均已完全恢復。因此，819 與她現在展示的 522 非常一致，我們提出了一個非常好的觀點。

And I think part of that has to do with the fact that it's being combined with cytoxan. So this is a kind of a one, two punch that we're seeing. Again two patients, I'm not going to sit here and speculate too much on it, but you are seeing the power of CAR plus hnCD16 in these settings. And I think both programs our data has been so far very encouraging.

我認為部分原因是它與環磷酰胺結合使用。所以我們看到了一種雙重打擊。再次，對於這兩名患者，我不會坐在這裡對此進行過多的猜測，但您在這些設置中看到了 CAR 加 hnCD16 的威力。我認為，到目前為止，這兩個項目的數據都非常令人鼓舞。

And Ethan, I'll just pick up on Scott's comments, qualitatively, I agree the mix of the business will change through the course of the year. But if you look at the first quarter, we had roughly $52 million, $53 million in GAAP operating expenses and about $37 million in cash burn. That's been pretty consistent for last couple of quarters.

伊桑，我只是想接斯科特的評論，從品質上講，我同意業務組合將在一年內發生變化。但如果你看一下第一季度，我們的 GAAP 營運費用約為 5,200 萬美元，5,300 萬美元，現金消耗約 3,700 萬美元。過去幾季的情況一直相當穩定。

So even though we have one or two programs winding down, the hope is that now that we have first patient dosed and we're beginning to clear dose levels in certain programs that's going to tick up throughout the year. So I expect that those numbers I just quoted was $53 million on the GAAP operating expense in the $37 million, $38 million on the cash burn effective cash burn for the quarter to remain fairly consistent.

因此，儘管我們有 1 或 2 個項目即將結束，但我們希望，既然我們已經為第一位患者進行了劑量測定，並且我們開始清除某些項目中的劑量水平，那麼這些劑量水平將在全年內逐漸上升。因此，我預計我剛才引用的數字是，本季 GAAP 營運費用為 5,300 萬美元，現金消耗為 3,700 萬美元，有效現金消耗為 3,800 萬美元，將保持相當穩定。

I'm more than happy to invest find these clinical programs. So that ticks up to call it circa $40 million on a cash burn basis. But we feel pretty good about where we are just the mix of business will evolve. That's a pretty good number to work with for the rest of the year.

我非常樂意投資尋找這些臨床項目。因此，以現金消耗計算，約為 4,000 萬美元。但我們對自己目前的狀況感到十分滿意，業務組合將會不斷發展。對於今年剩餘時間的工作來說，這是一個相當不錯的數字。

Thank you. Very helpful.

謝謝。非常有幫助。

This concludes our question and answer session. I would like to turn the conference back over to Scott Wolchko, for any closing remarks.

我們的問答環節到此結束。我想將會議交還給 Scott Wolchko，請他做最後發言。

Thank you. Thank you for everyone today for all your good questions on the ASGCT data. Appreciate all the input and thought and speak to you soon. Thank you.

謝謝。感謝大家今天就 ASGCT 數據提出的所有好問題。感謝您的所有意見和想法，我們將盡快與您聯繫。謝謝。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。