Fate Therapeutics Inc (FATE) 2023 Q3 法說會逐字稿

Welcome to the Fate Therapeutics Third Quarter 2023 Financial Results Conference Call. (Operator Instructions) The call is being webcast live on the Investors section of Fate's website at fatetherapeutics.com. As a reminder, today's call is being recorded. I would now like to introduce Scott Wolchko, President and CEO of Fate Therapeutics.

歡迎參加 Fate Therapeutics 2023 年第三季財務業績電話會議。 （操作員說明）此次電話會議正在 Fate 網站 fattherapeutics.com 的投資者部分進行網路直播。提醒一下，今天的通話正在錄音。現在我想介紹一下 Fate Therapeutics 總裁兼執行長 Scott Wolchko。

Thank you. Good afternoon, and thanks, everyone, for joining us for the Fate Therapeutics Third Quarter 2023 Financial Results Call. Shortly after 4:00 p.m. 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.

謝謝。下午好，感謝大家參加我們的 Fate Therapeutics 2023 年第三季財務業績電話會議。下午 4:00 過後不久今天東部時間，我們發布了包含這些結果的新聞稿，您可以在我們網站的投資者部分的新聞稿下找到該新聞稿。

In addition, our Form 10-Q for the quarter ended September 30, 2023, was filed shortly thereafter and can be found on the Investors section of our website under Financial Information. Before we begin, I would like to remind everyone that except for statements of historical facts, 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 Form Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

此外，我們隨後不久提交了截至 2023 年 9 月 30 日的季度的 10-Q 表格，可以在我們網站的「投資者」部分的「財務資訊」下找到。在開始之前，我想提醒大家，除了歷史事實的陳述外，管理層在本次電話會議上所做的陳述和對問題的回答均屬於1995年《私人證券訴訟表格法》安全港條款下的前瞻性陳述這些陳述涉及風險和不確定性，可能導致實際結果與此類前瞻性陳述中的結果有重大差異。

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 September 30, 2023, that was filed with the SEC today. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made as the 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.

請參閱今天收盤後發布的公司收益新聞稿的前瞻性聲明免責聲明，以及我們向 SEC 提交的截至 2023 年 9 月 30 日的季度 10-Q 表格中包含的風險因素今天。不應過度依賴前瞻性聲明，這些聲明僅代表發布之日的情況，因為這些前瞻性聲明所依據的事實和情況可能會發生變化。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. During today's discussion, we will cover several key milestones that we recently achieved for our iPSC product platform, including expanding the clinical reach of our iPSC-derived CAR T-cell platform to solid tumors as well as beyond oncology and into autoimmunity.

參加今天電話會議的有我們的財務長 Ed Dulac；以及我們的首席研發長 Bob Valamehr 博士。在今天的討論中，我們將介紹我們最近在iPSC 產品平台上實現的幾個關鍵里程碑，包括將iPSC 衍生的CAR T 細胞平台的臨床範圍擴大到實體瘤以及腫瘤學以外的領域，進入自身免疫領域。

In reaching these milestones, we are now well positioned to achieve important clinical readouts in oncology, and autoimmunity across multiple programs in 2024. We will also discuss our continued focus on controlling costs that has resulted in a significant decrease in cash utilization, which we believe enables us to extend our operating runway into the second half of 2025. Beginning with FT522, our off-the-shelf CD19-targeted CAR NK cell program, I am pleased to announce that our Phase I study is open for enrollment in patients with relapsed/refractory B-cell Lymphoma, where we intend to assess FT522 with and without conditioning chemotherapy. FT522 is the company's first product candidate to incorporate our proprietary alloimmune defense receptor or ADR technology, which is comprised of a synthetic engineered receptor designed to target 4-1BB expressed on alloreactive immune cells and induce NK cell proliferation.

在實現這些里程碑的過程中，我們現在處於有利位置，可以在2024 年在多個項目中實現腫瘤學和自體免疫的重要臨床讀數。我們還將討論我們繼續關注控製成本，這導致現金利用率大幅下降，我們相信這一點使我們能夠將運營跑道延長至2025 年下半年。從我們現成的CD19 靶向CAR NK 細胞項目FT522 開始，我很高興地宣布，我們的I 期研究已開放招募復發性癌症患者/難治性 B 細胞淋巴瘤，我們打算在有或沒有預處理化療的情況下評估 FT522。 FT522 是該公司首款採用我們專有的同種免疫防禦受體或ADR 技術的候選產品，該技術由合成工程受體組成，旨在靶向同種異體免疫細胞上表達的4-1BB 並誘導NK 細胞增殖。

In preclinical studies, we have shown that the engagement of ADR-armed CAR NK cells with alloreactive immune cells, mitigated rejection, promoted NK cell proliferation and increased antitumor activity. These preclinical data suggests that 522 has the potential to drive clinical responses without administration of intense conditioning chemotherapy to patients. The Phase I study includes two regimens: Regimen A or the conditioning arm which consists of 3 days of standard conditioning chemotherapy, 1 dose of rituximab and 3 doses of FT522. And regimen B or the node conditioning arm, which consists of 1 dose of rituximab and 3 doses of FT522 without Conditioning Chemotherapy.

在臨床前研究中，我們表明，攜帶 ADR 的 CAR NK 細胞與同種異體反應性免疫細胞結合，可減輕排斥反應，促進 NK 細胞增殖並增加抗腫瘤活性。這些臨床前數據表明，522 有潛力在無需對患者進行強烈調理化療的情況下推動臨床反應。 I 期研究包括兩種方案：方案 A 或預處理組，由 3 天的標準預處理化療、1 劑利妥昔單抗和 3 劑 FT522 組成。方案 B 或淋巴結調理組，由 1 劑利妥昔單抗和 3 劑 FT522 組成，無調理化療。

Enrollment into regimen A or the conditioning arm has now been opened at the first dose level of 300 million cells per dose and upon clearance of dose (inaudible) and toxicities at this first dose level, enrolling into regimen B, where the No Conditioning Arm will commence at its first dose level of 300 million cells per dose. Each, Regimen may proceed with dose escalation independently. Today, conditioning patients with intense chemotherapy is a necessary component of the treatment course for cell-based cancer immunotherapy, including for both autologous and allogeneic cell therapies. Conditioning Chemotherapy induces toxicities, limits patient access and prevents combination with standard of care immunotherapies widely used in the community-based setting.

方案 A 或調理組現已在每劑 3 億個細胞的第一劑量水平開放，在清除第一個劑量水平的劑量（聽不清）和毒性後，註冊方案 B，其中無調理組將從每劑3 億個細胞的第一劑量水平開始。每個方案都可以獨立進行劑量遞增。如今，對患者進行強化化療是基於細胞的癌症免疫療法（包括自體和同種異體細胞療法）治療過程中的必要組成部分。調理化療會引起毒性，限制患者接受治療，並妨礙與社區環境中廣泛使用的標準護理免疫療法相結合。

We believe we have the opportunity to establish clinical proof of concept for our ADR technology and for FT522 program without conditioning chemotherapy early in dose escalation. Turning now to our T-cell programs. We believe our multiplex engineered iPSC-derived CAR T-cell product platform is uniquely suited to bring a constellation of antitumor mechanisms to the fight against solid tumors. I'm pleased to announce that we have established a new landmark in the field of cell-based cancer immunotherapy. Our IND application was cleared by the FDA to initiate clinical investigation of FT825 in patients with solid tumors. The multiplexed engineered iPSC-derived CAR T-cell program, which is being codeveloped under our collaboration with Ono Pharmaceutical incorporates Seven Novel Synthetic Controls of cell function that are designed to harness the potential of both [innate] and adaptive immunity and to overcome the unique challenges in treating solid tumors.

我們相信，我們有機會為我們的 ADR 技術和 FT522 計畫建立臨床概念證明，而無需在劑量遞增早期進行預處理化療。現在轉向我們的 T 細胞計劃。我們相信，我們的多重工程 iPSC 衍生的 CAR T 細胞產品平台非常適合將一系列抗腫瘤機制用於對抗實體腫瘤。我很高興地宣布，我們在基於細胞的癌症免疫治療領域建立了一個新的里程碑。我們的 IND 申請已獲得 FDA 批准，啟動 FT825 在實體瘤患者中的臨床研究。我們與小野製藥 (Ono Pharmaceutical) 合作共同開發的多重工程化 iPSC 衍生 CAR T 細胞計畫包含七種新型細胞功能合成控制，旨在利用 [先天] 和適應性免疫的潛力，並克服獨特的治療實體瘤的挑戰。

These novel synthetic controls include a CXCR2 receptor to promote cell trafficking, a chimeric TGFß receptor to redirect immunosuppressive signals in the tumor microenvironment and a high affinity non-cleavable CD16 receptor to promote antibody-dependent cellular cytotoxicity. At the 2023 Society for Immunotherapy of Cancer annual meeting, we unveiled that at FT825 incorporates a novel cancer specific antigen binding domain targeting HER2. Which was contributed by Ono to our collaboration. Preclinical studies presented at the meeting demonstrated that the binding profile of the cancer-specific CAR construct is unique and differentiated from that of trastuzumab, exhibiting similar potency with greater specificity toward HER2-expressing malignant cells.

這些新穎的合成對照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訊號的嵌合 TGFα 受體以及促進抗體依賴性細胞毒性的高親和力不可裂解的 CD16 受體。在 2023 年癌症免疫治療協會年會上，我們發表了 FT825 結合了一種針對 HER2 的新型癌症特異性抗原結合結構域。這是小野為我們的合作所做的貢獻。會議上提出的臨床前研究表明，癌症特異性 CAR 構建體的結合特徵是獨特的，並且與曲妥珠單抗不同，對錶達 HER2 的惡性細胞表現出相似的效力和更高的特異性。

In subcutaneous xenograft models, FT825 demonstrated robust antitumor efficacy against HER2 high as well as HER2 low expressing tumor cells. Additionally, FT825-resistant TGFß data mediated suppression, maintaining robust cytolytic activity across multiple rounds of tumor challenge and suppressive levels of TGFß exposure and showed potent migration to CXCR2 ligands, which are often expressed in solid tumors. With the clearance of our IND by the FDA, Phase I study start-up activities are now ongoing at multiple sites.

在皮下異種移植模型中，FT825 對 HER2 高表達和 HER2 低表達的腫瘤細胞表現出強大的抗腫瘤功效。此外，FT825 抗藥性的 TGFα 數據介導抑制，在多輪腫瘤攻擊和抑制 TGFα 暴露水平中保持強大的細胞溶解活性，並顯示出向 CXCR2 配體（通常在實體瘤中表達）的有效遷移。隨著 FDA 批准我們的 IND，第一階段研究啟動活動目前正在多個地點進行。

The dose escalation schema for the Phase I study includes two treatment regimens. Regimen A or the Monotherapy Arm consists of a standard 3-day preconditioning regimen and a single dose of FT825 as monotherapy. Enrollment is the monotherapy arm will commence at the post dose level of 100 million cells. Eligibility includes patients with advanced HER2 expressing solid tumors. Regimen B or the Combination Arm consists of a standard 3-day preconditioning regimen and a single dose of FT825 in combination with cetuximab, where we seek to additionally exploit innate immunity by leveraging the product candidate's high-affinity, non-cleavable CD16 receptor to target EGFR expressed on solid tumor cells.

I 期研究的劑量遞增方案包括兩種治療方案。方案 A 或單一療法組由標準的 3 天預處理方案和單劑量 FT825 作為單一療法組成。單一療法組將從 1 億個細胞的劑量水平開始入組。資格包括患有晚期 HER2 表達實體瘤的患者。方案 B 或組合組由標準的 3 天預處理方案和單劑量 FT825 與西妥昔單抗組合組成，我們尋求透過利用候選產品的高親和力、不可裂解的 CD16 受體來額外利用先天免疫EGFR 在實體瘤細胞上表達。

Enrollment into Regimen B will commence the first dose level of 100 million cells upon clearance of dose-limiting toxicities at the first dose level of Regimen A. Eligibility includes patients with advanced EGFR-expressing solid tumors. While we have made great strides in advancing our most innovative and differentiated clinical programs in oncology, we also remain committed to pursuing new therapeutic opportunities beyond oncology where cell-based immunotherapies can have a profound clinical benefit for patients.

方案 B 的註冊將在方案 A 的第一個劑量水平的劑量限制性毒性被清除後開始 1 億個細胞的第一個劑量水平。資格包括患有晚期 EGFR 表達實體瘤的患者。雖然我們在推進腫瘤學領域最具創新性和差異化的臨床計畫方面取得了巨大進步，但我們仍致力於尋求腫瘤學以外的新治療機會，其中基於細胞的免疫療法可以為患者帶來深遠的臨床益處。

Our initial clinical data -- initial clinical data are now emerging, indicating that CD19 targeted CAR T-cell therapy has the potential to durably deplete a patient's pathogenic immune cells, drive immune reset and meaningfully improve quality of life across a wide spectrum of autoimmune diseases. We believe there is a very strong value proposition for off-the-shelf cell therapy in autoimmunity, where a relatively short-lived cell can deeply eradicate an aberrant B-cell population and enable rapid reconstitution of a healthy immune system and where patient safety, convenience, accessibility as well as cost and scale will be a differentiating factor.

我們的初步臨床數據—初步臨床數據現已出現，顯示CD19 靶向CAR T 細胞療法有潛力持久消除患者的致病性免疫細胞，推動免疫重置，並有意義地改善多種自體免疫疾病的生活品質。我們相信，現成的細胞療法在自身免疫領域具有非常強大的價值主張，其中壽命相對較短的細胞可以深度根除異常的 B 細胞群，並能夠快速重建健康的免疫系統，並且患者的安全，便利性、可近性以及成本和規模將是一個差異化因素。

To this end, I'm pleased to announce the clinical expansion of our iPSC product platform into autoimmunity. In July, the FDA cleared our IND application for clinical investigation of FT819 our off-the-shelf CD19 targeted CAR T-cell program in patients with SLE including for patients with active Lupus Nephritis or active SLE without renal cell involvement. We have now initiated Phase I study start-up activities at multiple sites. The Phase I study in SLE is designed to evaluate the safety, pharmakinetics, anti-B cell activity of a single dose of FT819 administered following a standard conditioning regimen consisting of either side flu or bendamustine. Dose escalation will commence at the first dose level of 360 million cells. Importantly, we have previously presented clinical data of a single dose of FT819 at doses up to 360 million cells in the setting of relapsed refractory B-cell lymphoma, where we reported safety and clinical activity.

為此，我很高興地宣布我們的 iPSC 產品平台已臨床擴展到自體免疫領域。 7 月，FDA 批准了我們對 FT819 進行臨床研究的 IND 申請，我們的現成 CD19 靶向 CAR T 細胞項目用於 SLE 患者，包括活動性狼瘡腎炎或無腎細胞受累的活動性 SLE 患者。我們現已在多個地點啟動第一階段研究啟動活動。 SLE 的 I 期研究旨在評估單劑量 FT819 的安全性、藥物動力學和抗 B 細胞活性，該劑量遵循由流感或苯達莫司汀組成的標準調理方案。劑量遞增將從 3.6 億個細胞的第一個劑量水平開始。重要的是，我們之前已經提供了單劑量 FT819（劑量高達 3.6 億個細胞）治療復發難治性 B 細胞淋巴瘤的臨床數據，並報告了安全性和臨床活性。

Of the first 11 patients treated with a single dose of FT819 at up to 360 million cells, we observed a favorable safety profile with no immune effector cell associated neurotoxicity and mild cytokine release syndrome. We observed antitumor activity in heavily pretreated patients, including 3 complete responses. And we observed CAR T-cell expansion that peaked in the peripheral blood between days 8 and 11. The Phase I study of FT819-SLE allows for assessment of higher dose levels, each up to 3x the highest cleared dose level as well as for the opening of multiple dose expansion cohorts, each of which may be enrolled in parallel. We are pleased to receive a favorable review of our FT819 clinical protocol from the clinical experts of the Protocol Design Committee of Lupus Therapeutics and affiliate of the Lupus Research Alliance.

在首批 11 名接受單劑量 FT819 治療（細胞數量高達 3.6 億）的患者中，我們觀察到良好的安全性，沒有免疫效應細胞相關的神經毒性和輕度細胞激素釋放症候群。我們觀察到經過大量治療的患者的抗腫瘤活性，包括 3 例完全緩解。我們觀察到CAR T 細胞擴增在第8 天到第11 天之間在外周血中達到峰值。FT819-SLE 的I 期研究允許評估更高的劑量水平，每個劑量水平高達最高清除劑量水平的3 倍，以及開放多個劑量擴展隊列，每個隊列可以並行入組。我們很高興收到狼瘡治療方案設計委員會和狼瘡研究聯盟附屬機構的臨床專家對我們的 FT819 臨床方案的好評。

We also continue to watch with keen interest, the emergence of additional clinical data in autoimmunity, and we are currently evaluating additional clinical expansion opportunities for FT819 as well as for FT522, where we think the potential to reduce conditioning chemotherapy and the target in between B cells, plasma cells and autoreactive T-Cells with an off-the-shelf ADR arm CD19 targeted CAR NK cell offers a highly differentiated therapeutic profile. We have remained resilient during these challenging times, and focused our attention on building a fully integrated operation that leads in the research, development and manufacture of multiplexed engineered iPSC-derived cellular immunotherapies.

我們也繼續懷著濃厚的興趣繼續關注自身免疫方面更多臨床數據的出現，我們目前正在評估 FT819 和 FT522 的更多臨床擴展機會，我們認為這有可能減少預處理化療和 B 之間的目標細胞、漿細胞和自體反應性T 細胞以及現成的ADR 臂CD19 可針對CAR NK 細胞提供高度差異化的治療方案。在這些充滿挑戰的時期，我們始終保持韌性，並專注於建立一個完全整合的業務，在多重工程 iPSC 衍生的細胞免疫療法的研究、開發和製造方面處於領先地位。

As we look towards 2024, we are well positioned to achieve important clinical readouts in oncology and autoimmunity across multiple programs. Clinical activities are now ongoing for our two most innovative oncology programs, FT522 in B-cell lymphoma and FT825 in solid tumors, as well as for our first autoimmunity program, FT819 and SLE. We also continue to advance our Phase I study of FT819 in B-cell malignancies, where we are enrolling patients in single dose treatment cohorts at 540 million cells in BCL and at 360 million cells in CLL. As well as our Phase I study of FT576 in multiple myeloma, where we are enrolling patients in 3 dose treatment cohorts at 1 billion cells per dose as monotherapy and in combination with CD38 targeted monoclonal antibody therapy.

展望 2024 年，我們處於有利地位，可以在多個項目中實現腫瘤學和自體免疫的重要臨床讀數。我們兩個最具創新性的腫瘤學計畫（B 細胞淋巴瘤的 FT522 和實體腫瘤的 FT825）以及我們的第一個自體免疫計畫 FT819 和 SLE 的臨床活動正在進行中。我們也繼續推進 FT819 在 B 細胞惡性腫瘤的 I 期研究，我們正在將患者納入單劑量治療隊列，BCL 細胞數為 5.4 億，CLL 細胞數為 3.6 億。以及我們針對 FT576 治療多發性骨髓瘤的 I 期研究，我們正在將患者納入 3 劑量治療組，每劑量 10 億個細胞作為單一療法，並與 CD38 靶向單克隆抗體療法相結合。

Finally, our investment in innovation continues, including under our solid tumor collaboration with Ono, as we continue to advance new multiplexed engineered CAR T-cell programs towards clinical development. We remain confident in our belief that our proprietary iPSC product platform is uniquely suited to create highly differentiated product candidates with the potential to deliver multiple mechanisms of action and therapeutic benefit to patients with cancer and autoimmune diseases. I'd now like to turn the call over to Ed to review our financial results for the third quarter.

最後，我們對創新的投資仍在繼續，包括與 Ono 的實體瘤合作，我們將繼續推動新的多重工程 CAR T 細胞計畫的臨床開發。我們仍然堅信，我們專有的 iPSC 產品平台非常適合創造高度差異化的候選產品，有可能為癌症和自體免疫疾病患者提供多種作用機制和治療益處。我現在想將電話轉給艾德，以審查我們第三季的財務表現。

Thank you, Scott, and good afternoon. Fate Therapeutics is in a solid financial position to advance our pipeline. Our cash, cash equivalents and investments at the end of the third quarter were approximately $350 million. In the third quarter of this year, our revenue declined to $1.9 million compared to $15 million for the same period last year. As indicated last quarter, our revenue is now derived exclusively from our collaboration with Ono Pharmaceutical and specifically reflects research funding associated with the development of a second product candidate against an undisclosed target in solid tumors.

謝謝你，斯科特，下午好。 Fate Therapeutics 擁有穩健的財務狀況來推進我們的產品線。截至第三季末，我們的現金、現金等價物和投資約為 3.5 億美元。今年第三季度，我們的營收下降至 190 萬美元，去年同期為 1,500 萬美元。如上季所示，我們的收入現在完全來自我們與小野製藥的合作，特別反映了與開發針對實體瘤未公開標靶的第二種候選產品相關的研究資金。

As a reminder, after opting into a U.S. and European co-development and co-commercialization arrangement with Ono for FT825 in the fourth quarter of last year, we now account for that program's reimbursable expenses have been offset within our research and development costs. We recognized $2.1 million of contra R&D expense in the quarter. Research and development expenses for the quarter decreased by 57% to $34.3 million. The decrease in our R&D expenses was attributable primarily to a decrease in salaries and benefits, including share-based compensation expense following the company's restructuring in the first quarter, and from lower clinical trial costs and lower demand for R&D materials and equipment.

提醒一下，去年第四季選擇與小野公司就 FT825 進行美國和歐洲共同開發和共同商業化安排後，我們現在將該計劃的可報銷費用已在我們的研發成本中抵銷。我們在本季確認了 210 萬美元的研發費用。該季度的研發費用下降 57% 至 3,430 萬美元。研發費用減少的主要原因是公司第一季重組後薪資和福利（包括股權激勵費用）的減少，以及臨床試驗成本的下降和研發材料和設備需求的減少。

General and Administrative expenses for the third quarter decreased by 12% to $18.9 million. The decline in our G&A expenses was attributable primarily to a decrease in salaries and benefits including share-based compensation expense. Total operating expenses for the third quarter declined 47% to $53.2 million, which includes $10.1 million of noncash 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 milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which triggered a first milestone payment to MSK in 2021.

第三季一般及行政費用下降 12%，至 1,890 萬美元。我們的一般管理費用下降主要是由於薪資和福利（包括股權激勵費用）的減少。第三季總營運費用下降 47% 至 5,320 萬美元，其中包括 1,010 萬美元的非現金股票補償費用。請注意，在開發現成的 iPSC 衍生 CAR T 細胞候選產品 FT819 方面，我們之前實現了與紀念斯隆凱特琳癌症中心修訂後的許可協議中規定的臨床里程碑，這觸發了第一個里程碑2021 年向MSK 斯隆付款。

Up to 2 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 $700,000 on a quarterly basis. In the third quarter, we recorded a noncash $1 million nonoperating benefit associated with the change in fair value. Our net loss for the quarter was $45.2 million or $0.46 per share. Finally, we reiterate guidance for full year GAAP operating expenses to be in the range of $265 million to $285 million. And that our year-end cash and investments will exceed $300 million.

根據 MSK 普通股隨後的交易價值（每股 100 至 150 美元），最多可向 MSK 支付 2 筆額外里程碑付款。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 70 萬美元。第三季度，我們記錄了與公允價值變動相關的 100 萬美元非現金非經營性收益。我們本季的淨虧損為 4,520 萬美元，即每股虧損 0.46 美元。最後，我們重申全年 GAAP 營運費用指引為 2.65 億至 2.85 億美元。我們的年終現金和投資將超過 3 億美元。

I would now like to open the call for questions.

我現在想開始提問。

(Operator Instructions) Our first question comes from Yigal Nochomovitz with Citi.

（操作員說明）我們的第一個問題來自花旗銀行的 Yigal Nochomovitz。

This is Ashiq Mubarack on for Yigal. I just have a couple. For FT522 in the Phase I, I'm just curious if you think if there's a certain threshold in drop-off and engraftment or maybe activity that you believe would be acceptable between patients who received preconditioning versus those that don't? Or does there really need to be no drop off for you to utilize that preconditioning free regimen in future studies?

我是阿希克·穆巴拉克 (Ashiq Mubarack)，替補伊加爾 (Yigal)。我只有一對。對於第一階段的 FT522，我只是好奇您是否認為在接受預處理的患者與未接受預處理的患者之間是否存在一定的脫落和植入閾值，或者您認為可以接受的活動？或者你真的不需要在未來的研究中使用這種免預處理方案嗎？

Yes. I don't, I think when we look at the data, I think the data is really going to be driven by, at the end of the day. Patient outcomes and responses, we're definitely interested in understanding the TK profile of FT522 with and without conditioning. And I think that will be help guide dose escalation. But ultimately, I think it's about patient benefit and driving patient benefit potentially with no conditioning, as that being the important element of 522 with respect to its unique profile.

是的。我不認為，我認為當我們查看數據時，我認為最終數據確實會受到驅動。患者的結果和反應，我們絕對有興趣了解 FT522 在有或沒有條件調節的情況下的 TK 概況。我認為這將有助於指導劑量遞增。但歸根結底，我認為這關乎患者利益，並在沒有條件限制的情況下潛在地推動患者利益，因為這是 522 因其獨特的形象而具有的重要元素。

Okay. I understood. We'll just have to see. I guess for FT825, I know you have this rituximab combo, but are you also planning to combine with trastuzumab or maybe trastuzumab deruxtecan given the differences in binding dynamics you showed at (inaudible). I'm just curious if you think an ADC combo might be something that's actually viable from a safety standpoint? Given your comments around the HER2 low opportunity.

好的。我明白了。我們只需要看看。我想對於FT825，我知道您有這種利妥昔單抗組合，但考慮到您在（聽不清楚）中顯示的結合動力學差異，您是否也計劃與曲妥珠單抗或曲妥珠單抗deruxtecan 組合。我只是好奇你是否認為 ADC 組合從安全角度來看實際上是可行的？鑑於您對 HER2 低機會的評論。

Yes, absolutely. We've started the study with combination with cetuximab, but we certainly think there's opportunity to broaden the clinical profile to include other monoclonal antibodies. There are several that we're looking at. One of those possibly is actually trastuzumab since there does not appear, at least preclinically, given competition between the binding domains. And in fact, we've actually seen, and I believe we've presented this publicly, we've seen quite nice synergy, in fact, with FT825 and trastuzumab.

是的，一點沒錯。我們已經開始與西妥昔單抗聯合進行研究，但我們當然認為有機會擴大臨床概況以包括其他單株抗體。我們正在研究幾個。其中之一可能實際上是曲妥珠單抗，因為至少在臨床前，結合域之間沒有出現競爭。事實上，我們已經看到，而且我相信我們已經公開展示了這一點，我們已經看到了 FT825 和曲妥珠單抗之間非常好的協同作用。

Our next question comes from Michael Yee with Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

This is Jenna on for Mike. We wanted to get your latest take on the landscape. The CD19 CAR-T is moving into earlier lines, and there are new players coming into the market, CAR-T and going after post CD19. So, in the context of all of that, where do you see the next-gen CAR NK program, CD19 ultimately fit into that landscape? And secondly, are you able to comment on how you're doing on enrollment? Have you enrolled any patients? And how soon do you think you may be able to start the no chemo arm?

這是麥克的珍娜。我們想了解您對景觀的最新看法。 CD19 CAR-T 正在進入早期產品線，並且有新的參與者進入市場，CAR-T 並追趕 CD19 之後的產品。那麼，在所有這些背景下，您認為下一代 CAR NK 專案 CD19 最終適合這種情況嗎？其次，您能否評論一下您在招生方面的表現？您入組患者了嗎？您認為多久可以開始非化療？

Sure. No, I'm going to comment on enrollment other than to reiterate the comments we made on the call where the study is open for enrollment. We have not announced the first patient. The first no conditioning patient, if you will, that patient has could be enrolled as early as patient 4. We are required to clear the first dose level in the conditioning arm before opening the no conditioning arm. So first, assuming they're DLT, the first 3 patients would receive conditioning and then 2 events can occur simultaneously. Number one, you can dose escalate the conditioning arm as well as open the no conditioning arm. And so the fourth patient could be a no conditioning patient.

當然。不，除了重申我們在研究開放註冊電話會議上發表的評論之外，我將對註冊發表評論。我們還沒有宣布第一個病人。第一個無調節臂（如果您願意）可以早於患者 4 進行登記。我們需要在打開無調節臂之前清除調節臂中的第一個劑量水平。因此，首先，假設他們是 DLT，前 3 名患者將接受調節，然後 2 個事件可以同時發生。第一，您可以增加調節臂的劑量並打開無調節臂。所以第四個病人可能是一個沒有調理的病人。

In terms of the landscape completely agree. It's a super competitive landscape. And I think there, I think at the same time, there are multiple opportunities that can exist from off-the-shelf cell therapy. I've talked extensively in the past that I absolutely believe there will be a line of therapy that is of allogeneic or off-the-shelf that can exist and will exist post auto CAR T-cell therapy, think there's significant view that exists, whether it be lymphoma or myeloma in post auto CAR-T cell patients. In addition, I think one of the exciting elements of cell therapy, again, to be explored determined is the potential, especially with NK cell is to plug in to standard immunotherapy regimens for instance, like an R-CHOP or an earlier line regimen in myeloma.

就風景而言完全同意。這是一個超級競爭的格局。我認為，我同時認為，現成的細胞療法可以有許多機會。我過去曾廣泛談論過，我絕對相信將會有一系列同種異體或現成的療法可以存在，並將在自動 CAR T 細胞療法後存在，我認為存在重要的觀點，無論是自體CAR-T細胞治療後患者的淋巴瘤還是骨髓瘤。此外，我認為細胞療法的一個令人興奮的元素，有待探索確定的是潛力，特別是對於 NK 細胞來說，是插入標準免疫治療方案，例如 R-CHOP 或早期的一線方案骨髓瘤。

I think those opportunities exist. I think one of the challenges that exists with, whether it be autologous or allogeneic cell therapy is today, those regimens bring side flu along for the ride. So if you want to combine with an existing regimen and reach patients early, including in a community setting, one of the hurdles to overcome potentially is side flu. And that's one of the reasons we're very excited about 522 and ADR and a potential to reduce, significantly reduce the dependency on conditioning and enable a more seamless combination with standard regimens that are used earlier in care in the community.

我認為這些機會是存在的。我認為，無論是自體細胞療法還是同種異體細胞療法，目前的挑戰之一是，這些療法都會帶來副作用。因此，如果您想結合現有的治療方案並儘早接觸患者（包括在社區環境中），則可能需要克服的障礙之一是副流感。這就是我們對 522 和 ADR 感到非常興奮的原因之一，以及它有可能減少、顯著減少對調節的依賴，並能夠與社區早期護理中使用的標準治療方案更加無縫地結合。

Our next question comes from Tyler Van Buren with TD Cowen.

我們的下一個問題來自泰勒·範布倫 (Tyler Van Buren) 和 TD Cowen。

As we think about the next 6 to 12 months, what will the one or two major value-creating events be in your view? And what should investors expect from them?

當我們思考未來 6 到 12 個月時，您認為一兩個主要的價值創造事件是什麼？投資者應該對他們有何期望？

Yes. I think the 3 that I think are worth just noting we're on, I highlighted in my comments. I think, we have an opportunity to develop, to demonstrate proof of concept with FT522, including in a no-cycle Regimen. I think that's -- it can be a pretty can be game changing to that potential if you can deliver cell therapies without Conditioning Chemotherapy. And essentially, for all intents and purposes, make a cell therapy looks like a monoclonal antibody therapy. In terms of how it can be delivered and reach patients. I think that's pretty game changing if we can demonstrate that with 522, it's ADR built in and no side flow.

是的。我認為值得一提的是，我在評論中強調了這三點。我認為，我們有機會開發、展示 FT522 的概念驗證，包括在無循環方案中。我認為，如果你能夠在不進行條件化療的情況下提供細胞療法，那麼它可能會改變這種潛力。從本質上講，無論出於何種意圖和目的，細胞療法看起來都像是單株抗體療法。就如何交付和到達患者而言。我認為，如果我們能夠證明 522 具有內建 ADR 並且沒有旁路流量，那麼這將徹底改變遊戲規則。

Also very excited about FT825, as you are probably well aware, there's been a lot of challenges in the solid tumor setting with CAR-T cells historically. I think there certainly have been toxicities of note, and I think the activity has been modest, at least compared to hematologic malignancies. 825 being an 8-point edited cell therapy and what I'll just sort of consider to be a fine-tuned binding domain against HER2. I think early on in that study given that we're starting at 100 million cells, we do have the opportunity potentially to show responses. And I think and safely show responses. And I think that would be a significant breakthrough with respect to the use of off-the-shelf cell therapies in solid tumors.

我們對 FT825 也非常興奮，您可能很清楚，歷史上 CAR-T 細胞在實體瘤治療中遇到了許多挑戰。我認為肯定存在值得注意的毒性，而且我認為這種活性是適度的，至少與血液惡性腫瘤相比是如此。 825 是一種 8 點編輯的細胞療法，我認為它是針對 HER2 的微調結合域。我認為，在該研究的早期階段，鑑於我們從 1 億個細胞開始，我們確實有機會表現出反應。我思考並安全地表現出回應。我認為這對於在實體瘤中使用現成的細胞療法將是一個重大突破。

And then finally, I'll note, and as noted in our call, moving into autoimmunity, I think we are one of the first companies to pioneer an off-the-shelf strategy in autoimmunity. I realize we're all sort of beginning this journey at the same time, both autologous and allogeneic. And I think the potential to show, for instance, what's been shown with the autologous programs in a small number of patients that you can durably deplete an aberrant T cell population and enable reconstitution of a healthy immune system and do that in a durable way, I think, could be really powerful.

最後，我要指出的是，正如我們在電話會議中指出的那樣，進入自體免疫領域，我認為我們是第一批在自體免疫領域率先採用現成策略的公司之一。我意識到我們都在同時開始這段旅程，無論是自體的還是同種異體的。我認為有潛力展示，例如，在少數患者中進行的自體程序表明，你可以持久地消除異常的 T 細胞群，並能夠重建健康的免疫系統，並以持久的方式做到這一點，我想，可能真的很強。

Thank you. Our next question comes from Daina Graybosch with Leerink Partners.

謝謝。我們的下一個問題來自 Leerink Partners 的 Daina Graybosch。

Yes, I wonder if you can talk about for autoimmunity, why start with FT819 rather than going to FT522? And how you think about both of those products and their potential ultimately in autoimmunity?

是的，我想知道您能否談談自身免疫，為什麼從 FT819 開始而不是從 FT522 開始？您如何看待這兩種產品及其最終在自體免疫方面的潛力？

Yes. I think FT819, obviously, and we've sort of alluded to this, has human clinical experience. To date has a highly differentiated what we consider to be safety profile. It's readily available off the shelf. And there's certainly a strong proof of concept for autologous CAR T-cell therapy. And as you know, we have shown antitumor activity, including complete responses with 819.

是的。我認為 FT819 顯然（我們已經提到過）具有人類臨床經驗。迄今為止，我們認為安全狀況具有高度差異性。它很容易買到。自體 CAR T 細胞療法的概念確實得到了強有力的證明。如您所知，我們已經顯示出抗腫瘤活性，包括 819 的完整反應。

So I think there is a very strong rationale for off-the-shelf cell therapy in autoimmunity. And at least in the cancer setting, we've seen all the sort of safety and activity hallmarks that we believe can have a differentiated profile in autoimmunity. We've talked about 522, potentially the benefits of an NK cell, which again has an exclusive safety profile in oncology.

所以我認為現成的細胞療法在自體免疫方面有非常充分的理由。至少在癌症環境中，我們已經看到了所有類型的安全性和活性標誌，我們相信這些標誌在自身免疫方面可以具有差異化特徵。我們已經討論過 522，NK 細胞的潛在好處，它在腫瘤學方面再次具有獨特的安全性。

I think with FT522, there is potentially a broader therapeutic appeal, including and especially if the ADR technology allows for a reduction or elimination of conditioning chemotherapy, which I think is somewhat of a barrier, obviously, in autoimmunity certainly more so than in oncology. And with FT522, as you know, we have the potential to combine with monoclonal antibody therapy. And I think with FT522, we're looking at, let's call it, sort of a broader array of potential autoimmune diseases that we could target given the multiple mechanisms of action that are built into 522 beyond CD19 targeting.

我認為FT522 可能具有更廣泛的治療吸引力，包括特別是如果ADR 技術允許減少或消除預處理化療，我認為這在某種程度上是一個障礙，顯然，在自身免疫領域肯定比在腫瘤學領域更是如此。如您所知，透過 FT522，我們有潛力與單株抗體療法結合。我認為透過 FT522，我們正在研究，我們可以稱之為更廣泛的潛在自體免疫疾病，鑑於 522 內建的多種作用機制超出了 CD19 的靶向範圍，我們可以將其作為目標。

So whether that be, for instance, targeting CD20 with a monoclonal antibody CD38 with a monoclonal antibody or potentially even targeting auto reactive 4-1BB expressing T- cells. So I think the FT522 profile has, the FT522 product candidate has potentially much broader reach than a CD19 targeted cell therapy.

例如，無論是用單株抗體靶向 CD20，還是用單株抗體靶向 CD38，甚至可能靶向表達自身反應性 4-1BB 的 T 細胞。因此，我認為 FT522 的概況表明，FT522 候選產品的潛在影響範圍比 CD19 標靶細胞療法要廣泛得多。

Our next question comes from Michael Schmidt with Guggenheim.

我們的下一個問題來自古根漢的邁克爾·施密特。

This is Kelsey on for Michael. I guess specifically for 825 in HER2 solid tumors, I guess what types of tumors should we expect in the Phase I? And I guess what kind of efficacy benchmark are you thinking about as we kind of get those patients in?

這是邁克爾的凱爾西。我想特別是對於 HER2 實體瘤中的 825，我想我們應該在 I 期中期待什麼類型的腫瘤？我猜當我們讓這些患者加入時，您正在考慮什麼樣的療效基準？

Yes. I think the efficacy is going to be judged by the particular patients that, that we will ultimately enroll. There is a fairly broad enrollment or inclusion criteria in the study. It's not limited to, for instance, HER2 IHC-3. So we can certainly enroll patients that are both high and low expressers of HER2 into that study.

是的。我認為療效將由我們最終招募的特定患者來判斷。該研究有相當廣泛的招募或納入標準。例如，它不限於 HER2 IHC-3。因此，我們當然可以將 HER2 高表達和低表達的患者納入研究。

Our next question comes from Peter Lawson with Barclays.

我們的下一個問題來自巴克萊銀行的彼得勞森。

Just on the solid tumor programs and circling back on that, the learnings from your prior NK cells and solid tumor that kind of rolled over to the current program. So what were the learnings there? And then your HER2 directed T-cell, where do you think that would fit in the treatment paradigm?

就實體瘤計畫而言，我們從先前的 NK 細胞和實體瘤中學到的知識會轉移到目前的計畫中。那麼那裡學到了什麼？然後你的 HER2 定向 T 細胞，你認為它適合治療範例嗎？

Yes. And so I think while we've shared some of the data that we've seen in NK cells with solid tumors. In the setting of solid tumors, including CAR NK cells, where with our most recent version of in solid tumors with the FT536, which was the (inaudible) the product candidate, we certainly saw activity at 100 million cells per dose. So I do think there is interesting activity that we've demonstrated in the past with off-the-shelf cell therapies. I think it would be premature for me to say, comment on, gosh, what do we know with respect to an NK cell versus a T-cell. I think they're just very different sort of cellular vehicles, if you will.

是的。所以我認為，雖然我們分享了一些我們在實體瘤 NK 細胞中看到的數據。在實體瘤（包括 CAR NK 細胞）的環境中，我們最新的實體瘤版本 FT536（這是（聽不清楚）候選產品）我們確實看到了每劑量 1 億個細胞的活性。所以我確實認為我們過去透過現成的細胞療法展示了有趣的活動。我認為現在評論“天啊，我們對 NK 細胞與 T 細胞了解多少”還為時過早。如果你願意的話，我認為它們只是非常不同類型的蜂窩車輛。

So I don't necessarily think you can extrapolate what we've seen in a small number of patients with NK cells to the sort of the T-cell vehicle, if you will. So we don't really do that sort of cross comparison between NK cells versus T-cells, especially in the solid tumor setting and knowing quite honestly, all the incremental innovation that's built in to 825.

因此，如果您願意的話，我認為您不一定可以將我們在少數具有 NK 細胞的患者中看到的情況推斷為 T 細胞載體的類型。因此，我們並沒有真正在 NK 細胞與 T 細胞之間進行這種交叉比較，特別是在實體瘤環境中，而且老實說，825 內建了所有漸進式創新。

Got you. And then I guess the follow-up question was just on where you think this HER2-directed T-cell would be positionedin a (inaudible)?

明白你了。然後我想後續問題只是關於您認為 HER2 定向 T 細胞將位於（聽不清楚）的什麼位置？

Yes. I think it's too early to comment on that. I think as we look at the HER2 landscape, obviously, what's being demonstrated with the ADCs are pretty remarkable. But I think what we're excited about at the same time is that, again, solid tumor settings patients are relapsing or significant unmet need. And I think what we're excited about as well is, there seems to the activity in HER2-expressing tumors that cover a breadth of different types of solid tumors.

是的。我認為現在對此發表評論還為時過早。我認為，當我們審視 HER2 領域時，顯然，ADC 所展現的效果非常出色。但我認為我們同時感到興奮的是，實體瘤患者正在復發或顯著未被滿足的需求。我認為我們也感到興奮的是，表達 HER2 的腫瘤似乎涵蓋了多種不同類型的實體腫瘤。

So I think that we're now seeing HER2 starting to become validated, as actually, if you're able to target HER2 well, not in what you would think of just the traditional setting, for instance, of breast cancer. So I think the opportunity for safely targeting HER2 in the solid tumor space is significantly expanding.

因此，我認為我們現在看到 HER2 開始得到驗證，實際上，如果您能夠很好地靶向 HER2，而不是像您想像的那樣僅在傳統環境中（例如乳腺癌）。因此，我認為在實體瘤領域安全靶向 HER2 的機會正在顯著擴大。

Our next question comes from Andrea Tan with Goldman Sachs.

我們的下一個問題來自高盛的 Andrea Tan。

This is [Hawaney] on for Andrea. Firstly, for FT819, would you mind you sharing a bit more about the rationale for choosing Lupus as the initial autoimmune indication. And then secondly, if you could provide a bit more details around the clinical trial design for the Phase I study?

這是安德里亞的[哈瓦尼]。首先，對於 FT819，您介意您分享更多關於選擇狼瘡作為初始自體免疫適應症的理由嗎？其次，您能否提供更多 I 期研究臨床試驗設計的細節？

Yes. I think the rationale for starting in Lupus is there's strong clinical precedent for CD19 targeted therapy, and there is significant enthusiasm from the Lupus Community in treating patients with cell therapy. So I think it's a terrific place to start. The trial design, I alluded to on the call, it's a pretty standard design with respect to a cell therapy that we're seeing that others are exploring. It's a dose escalation study.

是的。我認為開始治療狼瘡的理由是 CD19 標靶治療有很強的臨床先例，並且狼瘡社群對細胞療法治療患者表現出極大的熱情。所以我認為這是一個很好的起點。我在電話中提到的試驗設計，對於我們看到其他人正在探索的細胞療法來說，這是一個非常標準的設計。這是一項劑量遞增研究。

We can treat it multiple escalating doses, stepping up at 3x the previously cleared dose level, each dose level each and every dose level that clears DLT is able to expand and enroll 10 patients in expansion. So you can explore multiple different dose levels and multiple different expansions. Assuming that dose level has cleared DLT. We are able to enroll patients with Lupus Nephritis as well as patients with other organ involvement.

我們可以多次遞增劑量來治療它，以先前清除的劑量水平的 3 倍遞增，每個劑量水平清除 DLT 的每個劑量水平都能夠擴展並在擴展中招募 10 名患者。因此您可以探索多種不同的劑量水平和多種不同的擴展。假設劑量水平已清除 DLT。我們能夠招募狼瘡性腎炎患者以及其他器官受影響的患者。

Thank you. Our next question comes from Yanan Zhu with Wells Fargo.

謝謝。我們的下一個問題來自富國銀行的朱亞楠。

First on the Lupus study for FT819. I was wondering I think you mentioned the lympho depletion regimen is standard. I'm wondering how does it compare with German Group's lympho depletion regimen? And also if you...

首先是關於 FT819 的狼瘡研究。我想知道你提到淋巴清除方案是標準的。我想知道它與德國集團的淋巴清除方案相比如何？而且如果你...

It's exactly the same regimen.

這是完全相同的治療方案。

Great. That's very helpful. And another question on FT522 for the no lympho depletion regimen, I was wondering the 300 million times 3, that dose regimen as the starting dose, what's your expectation in terms of how much T-cells can that dose remove? Do you think it's -- it could be possible that that's enough to remove all the T-cell or you might need to dose escalate simply on the basis of clearing more T-cells as opposed to optimizing for antitumor activity?

偉大的。這非常有幫助。關於 FT522 的另一個問題，關於無淋巴細胞清除方案，我想知道 3 億次 3，該劑量方案作為起始劑量，您對該劑量可以去除多少 T 細胞的期望是什麼？您是否認為這可能足以清除所有 T 細胞，或者您可能需要僅在清除更多 T 細胞的基礎上增加劑量，而不是優化抗腫瘤活性？

Difficult for me to answer that question today. We're certainly going to prioritize translational data in understanding differences between the doses. Keep in mind that this is not all about at the end of the day, it's not really about lympho conditioning through ADR. It's about the ADR technology potentiating the NK cell. And so the mechanism of action is not necessarily through conditioning removal of T-cells. Not all T-cells express 4-1BB, in fact, only, for instance, the alloreactive T-cell compartment is the primary expresser of 4-1BB. So this is not really a lympho conditioning approach. It's meant to defend the cell from potential forces of rejection.

今天我很難回答這個問題。在理解劑量之間的差異時，我們當然會優先考慮轉化數據。請記住，這並不是最終的全部，也不是真正透過 ADR 進行淋巴調節。這是關於增強 NK 細胞的 ADR 技術。因此，作用機制不一定是透過條件清除 T 細胞。並非所有 T 細胞都表達 4-1BB，事實上，僅同種異體反應性 T 細胞區室是 4-1BB 的主要表達者。所以這並不是真正的淋巴調理方法。它的目的是保護細胞免受潛在排斥力的影響。

It's also a receptor. It is a CAR against 4-1BB. So it potentiates the NK cell and provides additional activating signal. And at least in preclinical models, we've seen synergistic activity between NK cells and T-cells and increased antitumor activity.

它也是一種受體。這是對抗 4-1BB 的 CAR。因此它可以增強 NK 細胞並提供額外的活化訊號。至少在臨床前模型中，我們已經看到 NK 細胞和 T 細胞之間的協同活性以及抗腫瘤活性的增強。

Got it. That's very helpful. And then lastly, in terms of your consideration for FT522 for autoimmune disorders, I was wondering what might be the catalyst that prompt that decision? Would it be the observation in this cancer study and see how the non lympho depletion regimen is doing? Or is it something else?

知道了。這非常有幫助。最後，就您對 FT522 治療自體免疫疾病的考慮而言，我想知道促使您做出這項決定的催化劑是什麼？這是否是這項癌症研究的觀察結果，看看非淋巴球清除方案的效果如何？還是別的什麼？

Yes. I think the 522 study in oncology certainly can inform how we design the study in autoimmune or study in autoimmunity with 522. I think, quite honestly, at least as I sit here today, I could imagine a study with 522 in autoimmunity that actually would test something very similar to what we're doing in oncology, plus or minus (inaudible).

是的。第522章 522測試一些與我們在腫瘤學中所做的非常相似的東西，加或減（聽不清楚）。

Our next question comes from Etzer Darout with BMO Capital Markets.

我們的下一個問題來自 BMO 資本市場的 Etzer Darout。

Just a question here on the Systemic Lupus Program. Are you, the preclinical data that, I'm assuming you've generated when could we see the data there? If you are indeed generating that type of data? And then ultimately, just getting us, trying to get a sense of how you think that the platform here with 819 compared to sort of some of the emerging data around other assets that are exploring sort of Systemic Lupus?

這裡只是關於系統性狼瘡計畫的問題。我假設您已經產生了臨床前數據，我們什麼時候可以看到那裡的數據？如果您確實正在產生該類型的資料？最後，讓我們試著了解您如何看待 819 的平台與正在探索系統性紅斑狼瘡的其他資產的一些新興數據相比？

Sure. I mean there is a, there's a slide in our presentation -- investor deck in vitro. But it does look at, and I'll let Bob talk to it a little bit. It does certainly look at, for instance, the B-cell depletion with both 522 and 819 compares them head-to-head against, for instance, the primary T-cells if I'm not mistaken.

當然。我的意思是，我們的簡報中有一張幻燈片——體外投資者平台。但它確實會看，我會讓鮑伯和它談談。例如，如果我沒記錯的話，它確實會觀察 522 和 819 的 B 細胞耗竭情況，並將它們與初級 T 細胞等進行正面比較。

Yes. So our initial study does, in fact, do that. We've taken samples from healthy patients or healthy donors, SLE patients and arthritis patients. And we can clearly see very distinct and specific elimination of the B-cell component within those 3 populations. But I would also reference you back to Michelle (inaudible) , the collaboration publication that we've had about a year ago now. In nature biomedical engineering, where there's a whole stool of in vitro and in vivo studies showing the durability of the activity of FT819 in targeting B-cell.

是的。事實上，我們最初的研究確實做到了這一點。我們從健康患者或健康捐贈者、系統性紅斑狼瘡患者和關節炎患者身上收集了樣本。我們可以清楚地看到這 3 個群體中 B 細胞成分的消除非常明顯且特異。但我還要向您提及《米歇爾》（聽不清楚），這是我們大約一年前出版的合作出版品。在自然生物醫學工程領域，大量的體外和體內研究表明 FT819 靶向 B 細胞的活性具有持久性。

And then the other thing that we talked to in the past, which we've not presented yet publicly, we are looking for opportunity to do that. In terms of clinical proof of concept, we have looked at cohorts of patients in both the 819 oncology study as well as the prior 596 study in oncology, where in some of those patients, we were able to detect B-cells in those patients at baseline.

然後，我們過去討論過的另一件事，我們尚未公開展示，我們正在尋找機會做到這一點。在臨床概念驗證方面，我們研究了 819 腫瘤學研究以及先前的 596 腫瘤學研究中的患者隊列，在其中一些患者中，我們能夠在基線。

And we were able to go back and look at, for instance, the kinetics and depth of B-cell depletion. In patients -- in oncology receiving 819 and or receiving FT596.

例如，我們能夠回過頭來觀察 B 細胞耗竭的動力學和深度。在腫瘤科接受 819 和/或接受 FT596 的患者中。

And our last question comes from Mara Goldstein with Mizuho.

我們的最後一個問題來自瑞穗的瑪拉‧戈爾茨坦。

So I just wanted to go back to the autoimmune question. Really maybe to understand not so much FT819 versus 522, but 819 versus the rest of the field of CARs. And, but, and then the other question is, do you think of 819 as a bridge into looking at other constructs in autoimmune in the same way you went through that process with NKs.

所以我想回到自體免疫問題。也許真正理解的不是 FT819 與 522 的對比，而是 819 與 CAR 領域其他產品的對比。但是，另一個問題是，您是否認為 819 是研究自體免疫中其他結構的橋樑，就像您對 NK 進行該過程一樣。

Yes. I think it's a little too early to know. I mean the field is very enthused by the potential of taking cell therapies into autoimmunity. And in a small number of patients, and I would potentially say in a carefully selected number of patients in some academic studies, we've seen some pretty remarkable results. I think it's really early for the field. And ultimately, what are the therapeutic requirements that best serve patients and induce long-term drug-free remission, which I think is the excitement in particular about cell therapies. I think we're all going to learn a lot about that, quite honestly, in the next 3, 6, 12, 18 months. As we explore at least the first versions of autologous and allogeneic CD19 targeted CAR T-cell therapies.

是的。我認為現在知道還為時過早。我的意思是，該領域對將細胞療法應用於自身免疫的潛力非常感興趣。在少數患者中，我可能會說，在一些學術研究中精心挑選的患者中，我們已經看到了一些非常顯著的結果。我認為這個領域現在還為時過早。最終，最適合患者並誘導長期無藥物緩解的治療要求是什麼，我認為這是細胞療法特別令人興奮的地方。老實說，我認為在接下來的 3、6、12、18 個月內，我們都會學到很多。當我們探索至少第一個版本的自體和同種異體 CD19 標靶 CAR T 細胞療法時。

And just on the autoimmune study, how many sets are you going to start in the U.S.?

就自體免疫研究而言，您將在美國開始多少組？

Yes. We're working through that. I can think one of the strategies, quite honestly, with respect that we have heard in speaking with folks in the field is that they in these early days. They really do like to partner as much as they can with an oncologist that has significant experience in CAR T-cell therapy. And so for us, as you know, we are running the 819 study in oncology in, I think, somewhere between 12 to 15 sites are open.

是的。我們正在解決這個問題。老實說，我認為我們在與該領域的人們交談時聽到的策略之一就是早期的策略。他們確實希望盡可能多地與在 CAR T 細胞治療方面擁有豐富經驗的腫瘤學家合作。因此，對於我們來說，如您所知，我們正在進行 819 腫瘤學研究，我認為，大約有 12 到 15 個站點是開放的。

And so as we think about how to most effectively get 819 off the ground in autoimmunity, we're excited to partner with some of those sites as an example. So we're very familiar with 819, are currently enrolling patients and provide that sort of partnering opportunity with the oncologist and hematologists to treat patients.

因此，當我們思考如何最有效地讓 819 在自體免疫方面取得進展時，我們很高興能與其中一些網站合作作為例子。所以我們對 819 非常熟悉，目前正在招募患者，並提供與腫瘤學家和血液學家合作的機會來治療患者。

That concludes the question-and-answer session. I'd like to turn the call back over to Scott Wolchko for closing remarks.

問答環節到此結束。我想將電話轉回給斯科特·沃爾奇科 (Scott Wolchko)，讓其結束語。

Thank you, and thank you all for participation in today's call. Hope all of you make it out here for ASH in San Diego, and happy to sit down and spend some time with you. Thank you very much.

謝謝大家，也謝謝大家參加今天的電話會議。希望你們所有人都能夠參加聖地亞哥的 ASH，並很高興坐下來與你們共度時光。非常感謝。

Thank you. This concludes the program. Thank you for your participation. You may now disconnect. Everyone, have a great day.

謝謝。程式到此結束。感謝您的參與。您現在可以斷開連線。大家，祝你有美好的一天。