Cellectis SA (CLLS) 2023 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning, everyone, and welcome to Cellectis First quarter 2023 Earnings Call. (Operator Instructions)

    大家早上好,歡迎參加 Cellectis 2023 年第一季度財報電話會議。 (操作員說明)

  • Please be aware that today's conference call is being recorded. I'd now like to introduce the first speaker, Arthur Stril, Chief Business Officer. Please go ahead, sir.

    請注意,今天的電話會議正在錄音。現在我想介紹第一位演講者,首席商務官 Arthur Stril。請繼續,先生。

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Good morning, and welcome, everyone, to Cellectis' First Quarter 2023 Corporate Updates and Financial Results Conference Call.

    早上好,歡迎大家參加 Cellectis 2023 年第一季度公司最新動態和財務業績電話會議。

  • Joining me on the call today with prepared remarks are Dr. Andre Choulika, our Chief Executive Officer; Dr. Bing Wang, our Chief Financial Officer; and Dr. Mark Frattini, our Chief Medical Officer.

    今天與我一起參加電話會議並發表事先準備好的講話的是我們的首席執行官安德烈·喬利卡 (Andre Choulika) 博士;王兵博士,我們的首席財務官;以及我們的首席醫療官 Mark Frattini 博士。

  • Yesterday evening, Cellectis issued a press release reporting its financial results for the 3-month period ended March 31, 2023. The report and press release are available on our website at www.cellectis.com.

    昨天晚上,Cellectis 發布了一份新聞稿,報告了截至 2023 年 3 月 31 日的三個月期間的財務業績。該報告和新聞稿可在我們的網站 www.cellectis.com 上獲取。

  • As a reminder, we will make statements regarding Cellectis' financial outlook in addition to its manufacturing, regulatory and product development standards and plans and product development of its license partners. These forward statements, which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our license partners are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F filed with the Securities and Exchange Commission, SEC, and the financial report, including the management reports for the year ended on December 31, 2022, and subsequent filings Cellectis makes with the SEC from time to time.

    謹此提醒,除了其製造、監管和產品開發標準以及許可合作夥伴的計劃和產品開發之外,我們還將就 Cellectis 的財務前景發表聲明。這些前瞻性陳述基於我們管理層當前的預期和假設以及管理層當前可獲得的信息,包括我們的許可合作夥伴提供或以其他方式公開報告的信息,存在可能導致實際結果與預測不同的風險和不確定性。這些風險的描述可以在我們向美國證券交易委員會 (SEC) 提交的最新 20-F 表格和財務報告中找到,包括截至 2022 年 12 月 31 日的年度管理報告以及 Cellectis 提交的後續文件不時與 SEC 聯繫。

  • I would now like to turn the call over to Andre.

    我現在想把電話轉給安德烈。

  • Andre Choulika - Co-Founder, CEO & Director

    Andre Choulika - Co-Founder, CEO & Director

  • Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Cellectis made significant progress with it's pipeline this quarter. We took a notable step forward with the first patient being dosed in France with our in-house manufactured product candidate, UCART22 is evaluated in the BALLI-01 clinical study. This is an important advancement for the Cellectis' team who has worked tirelessly to expand the BALLI-01 clinical study to Europe.

    謝謝你,亞瑟。早上好,謝謝大家今天加入我們。 Cellectis 本季度的產品線取得了重大進展。我們向前邁出了顯著的一步,第一位患者在法國接受了我們內部生產的候選產品 UCART22 的給藥,並在 BALLI-01 臨床研究中進行了評估。對於 Cellectis 團隊來說,這是一個重要的進步,他們一直在不懈努力,將 BALLI-01 臨床研究擴展到歐洲。

  • UCART22 is currently the most advanced allogeneic CAR-T cell products and development for relapsed or refractory B-cell acute lymphoblastic leukemia. We believe that our off-the-shelf treatment approach, coupled with our ability to manufacture UCART-T product candidate, completely in-house, give us a competitive advantage on the market. It potentially maximizes the chances for eligible patients to be treated without delay. On the business development front, our partnerships proved to be an exciting highlight for Cellectis.

    UCART22是目前最先進的同種異體CAR-T細胞產品,針對複發或難治性B細胞急性淋巴細胞白血病而開發。我們相信,我們現成的治療方法,加上我們完全內部生產 UCART-T 產品候選產品的能力,使我們在市場上具有競爭優勢。它可能會最大限度地提高符合條件的患者立即接受治療的機會。在業務發展方面,我們的合作夥伴關係被證明是 Cellectis 的一個令人興奮的亮點。

  • Last month, we announced that we have implemented the use of Sanofi's alemtuzumab as only selective investigational medicine product Coded as CLLS52 as part of the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial, for UCART12 in the AMELI-01 clinical trial and for UCART20X22 in the NATHALI clinical trial.

    上個月,我們宣布,我們已將賽諾菲的阿崙單抗作為編碼為 CLLS52 的唯一選擇性研究藥物產品,作為 BALLI-01 臨床試驗中 UCART22、AMELI-01 臨床試驗中 UCART12 和 AMELI-01 臨床試驗中 UCART12 淋巴清除方案的一部分。 UCART20X22在NATHALI臨床試驗中。

  • This follows the partnership and supplies agreement that we entered with Sanofi regarding alemtuzumab. This quarter, we were proud to present encouraging preclinical data at the American Association for Cancer Research Annual Meeting on TALEN edited MUC1 CART-T cell to enhance efficacy in targeting triple-negative breast cancer. The data showed the capability of armored allogenic MUC1 CART-T cell with sophisticated gene edits to excel in the immune suppressive tumor and microenvironment, suggesting that there could be an effective option in treating patients with limited therapeutic options. We're proud of these results that reinforces the performance of our technologies and our commitment to treat cancer patients.

    這是我們與賽諾菲就阿崙單抗達成的合作夥伴關係和供應協議之後的結果。本季度,我們很自豪地在美國癌症研究協會年會上展示了關於 TALEN 編輯的 MUC1 CART-T 細胞的令人鼓舞的臨床前數據,以增強針對三陰性乳腺癌的功效。數據顯示,經過複雜基因編輯的裝甲同種異體 MUC1 CART-T 細胞能夠在免疫抑制性腫瘤和微環境中表現出色,這表明可能有一種有效的選擇來治療治療選擇有限的患者。我們對這些結果感到自豪,這些結果增強了我們技術的性能以及我們對治療癌症患者的承諾。

  • We also announced that 2 abstracts have been accepted at the upcoming American Society of Cell and Gene Therapy Annual Meeting. Cellectis will present clinical data on the AMELI-01 clinical trial in evaluating UCART123 that were already showcased in an oral presentation at the ASH Annual Meeting, as well as preclinical data on multiplex engineering for superior generation of CART-T cells. Those presentation will take place on May 17 in the Los Angeles.

    我們還宣布,即將召開的美國細胞與基因治療學會年會已接受 2 份摘要。 Cellectis 將展示評估 UCART123 的 AMELI-01 臨床試驗的臨床數據(這些數據已在 ASH 年會上的口頭報告中展示),以及高級 CART-T 細胞的多重工程的臨床前數據。這些演示將於 5 月 17 日在洛杉磯舉行。

  • This quarter, Cellectis announced the closing of the global offering of $25 million of its depository shares launched in February. The net proceeds of the global offering is approximately $22.8 million.

    本季度,Cellectis 宣布完成 2 月份推出的 2500 萬美元存託股票全球發行。全球發售的淨收益約為2280萬美元。

  • Finally, in April, we announced that the drop-down of the first tranche of the EUR 20 million under the finance contract for up to EUR 40 million credit facility made with the European Investment Bank in December 2022. Cellectis plan to use the net proceeds of the funds to focus on the development of its pipeline of allogeneic CART-T cell product candidate, UCART22, UCART20x22 and UCART123 and decided to stop enrollment of treatment of patients with UCARTCS1.

    最後,我們在 4 月份宣布,將根據 2022 年 12 月與歐洲投資銀行達成的最高 4000 萬歐元信貸額度的融資合同中的第一筆 2000 萬歐元進行撥款。Cellectis 計劃使用淨收益這筆資金將重點用於開發其同種異體 CART-T 細胞候選產品 UCART22、UCART20x22 和 UCART123 的管道,並決定停止 UCARTCS1 患者的治療入組。

  • To accelerate the speed of enrollment of patients in the MELANI-01 study evaluating UCARTCS1, the company would have had to invest meaningful amount of resources. Therefore, to optimize its resources, Cellectis decided to focus its development efforts under BALLI-01, AMELI-01 and NAtHaLI-01 studying and stop MELANI-01.

    為了加快評估 UCARTCS1 的 MELANI-01 研究的患者入組速度,該公司必須投入大量資源。因此,為了優化其資源,Cellectis決定將其開發重點放在BALLI-01、AMELI-01和NAtHaLI-01研究上,並停止MELANI-01。

  • Lastly, based on our current plan, we anticipate our cash runway to take us into the third quarter of 2024. We're excited about the drive in our clinical trials, building on the momentum of our lead print product candidate in our pipeline, and the upcoming milestones for 2023.

    最後,根據我們目前的計劃,我們預計我們的現金跑道將帶我們進入 2024 年第三季度。我們對臨床試驗的推動感到興奮,建立在我們管道中領先印刷產品候選者的勢頭之上,並且2023 年即將到來的里程碑。

  • With that, I would like to turn the call over to Dr. Mark Frattini, our Chief Medical Officer, who will give us an overview of the clinical trials. Mark, please go ahead.

    接下來,我想將電話轉給我們的首席醫療官 Mark Frattini 博士,他將為我們概述臨床試驗的情況。馬克,請繼續。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Thank you, Andre. As Andre mentioned, we have made progress in our BALLI-01 clinical trial with the dosing of our first patient in Europe with our in-house manufactured product candidate, UCART22. UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is evaluated in the BALLI-01 clinical study, a Phase I/IIa open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

    謝謝你,安德烈。正如 Andre 提到的,我們的 BALLI-01 臨床試驗取得了進展,我們的內部生產的候選產品 UCART22 已在歐洲對第一位患者進行了給藥。 UCART22 是一種針對 CD22 的同種異體 CAR T 細胞候選產品,並在 BALLI-01 臨床研究中進行了評估,該研究是一項 I/IIa 期開放標籤研究,旨在評估該候選產品在復發 / 癌症患者中的安全性和臨床活性。難治性 B 細胞急性淋巴細胞白血病。

  • The last preliminary data presented in the live webcast last December support the continued administration of UCART22 after FCA lymphodepletion,in patients with relapsed/refractory B-cell ALL and are very encouraging for patients who have limited, if any, treatment options, especially for those who have failed prior CD19 directed CART-T cell therapy and allogeneic stem cell transplant.

    去年12月網絡直播中提供的最後初步數據支持在復發/難治性B細胞ALL患者中FCA淋巴細胞清除後繼續給予UCART22,並且對於治療選擇有限(如果有的話)的患者來說非常令人鼓舞,特別是對於那些之前 CD19 定向 CART-T 細胞療法和同種異體幹細胞移植失敗的人。

  • The BALLI-01 study is actively enrolling patients after FCA lymphodepletion.

    BALLI-01 研究正在積極招募 FCA 淋巴清除後的患者。

  • Our AMELI-01 study evaluating UCART123 in patients with relapsed/refractory AML continues to progress and enroll patients in the FCA 2-dose regimen arm. We look forward to sharing clinical data from this program when it becomes available.

    我們的 AMELI-01 研究評估了 UCART123 對複發/難治性 AML 患者的治療效果,該研究繼續取得進展,並將患者納入 FCA 2 劑量方案組。我們期待在該計劃可用時分享該計劃的臨床數據。

  • Next, I'll move on to our MELANI-01 clinical trial, our CS1-directed TALEN gene-edited allogeneic CAR T-cell product candidate being evaluated in patients with relapsed or refractory multiple myeloma. As Andre previously mentioned, in order to focus on the development of our pipeline of allogeneic CAR T-cell product candidates, UCART22, UCAR20x22 and UCART123, we decided to stop enrollment and treatment of patients in the MELANI-01 study evaluating UCARTCS1.

    接下來,我將繼續進行 MELANI-01 臨床試驗,這是我們的 CS1 導向的 TALEN 基因編輯同種異體 CAR T 細胞候選產品,正在復發或難治性多發性骨髓瘤患者中進行評估。正如 Andre 之前提到的,為了專注於同種異體 CAR T 細胞候選產品 UCART22、UCAR20x22 和 UCART123 管道的開發,我們決定停止評估 UCARTCS1 的 MELANI-01 研究中的患者入組和治療。

  • Lastly, I will speak about our NAtHaLI-01 study evaluating UCART20x22. UCART20x22 is Cellectis' first allogeneic duo CART-T cell product candidate being developed for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. UCART20x22 is also the first product candidate Cellectis has designed, developed and manufactured completely in-house.

    最後,我將談談我們評估 UCART20x22 的 NAtHaLI-01 研究。 UCART20x22 是 Cellectis 的第一個同種異體雙 CART-T 細胞候選產品,正在為複發或難治性 B 細胞非霍奇金淋巴瘤患者開發。 UCART20x22 也是 Cellectis 完全內部設計、開發和製造的第一個候選產品。

  • In addition, the advantage of UCART20x22 is that it goes beyond the highly competitive CD19 antigen directed therapy space by providing a dual antigen CD20 and CD22 targeted allogeneic alternative. Cellectis is now enrolling patients in the NATHALI-01 trial.

    此外,UCART20x22的優勢在於,它通過提供雙抗原CD20和CD22靶向同種異體替代方案,超越了競爭激烈的CD19抗原定向治療空間。 Cellectis 目前正在招募患者參加 NETHALI-01 試驗。

  • Lastly, as Andre mentioned, Cellectis announced that we have implemented the use of Sanofi's alemtuzumab as a selective investigational medicinal product,coded as CLS 52 as part of the lymphodepletion regimen in the BALLI-01, AMELI-01 and the MELANI-01 clinical trials. As previously reported, the importance of alemtuzumab in the lymphodepletion regimen was demonstrated in our BALLI-01 and AMELI-01 studies, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCART-T cell expansion, allowing for greater clinical activity. We believe these encouraging outcomes are a meaningful step forward to a safe, effective and controllable therapeutic window for our allogeneic CAR-T cell product candidates.

    最後,正如 Andre 提到的,Cellectis 宣布我們已在 BALLI-01、AMELI-01 和 MELANI-01 臨床試驗中使用賽諾菲的阿崙單抗作為選擇性研究藥物,代碼為 CLS 52,作為淋巴細胞清除方案的一部分。如之前報導的,阿崙單抗在淋巴細胞清除方案中的重要性在我們的 BALLI-01 和 AMELI-01 研究中得到了證明,其中在氟達拉濱和環磷酰胺方案中添加這種淋巴細胞清除劑與持續淋巴細胞清除和顯著升高的 UCART-T 細胞相關擴展,允許更大的臨床活動。我們相信這些令人鼓舞的結果是我們的同種異體 CAR-T 細胞候選產品向安全、有效和可控的治療窗口邁出的有意義的一步。

  • With that, I would like to hand the call over to Dr. Bing Wang, Cellectis' Chief Financial Officer, for an overview of our financials for the first quarter of 2023. Bing, please go ahead.

    接下來,我想將電話轉交給 Cellectis 首席財務官 Bing Wang 博士,以概述我們 2023 年第一季度的財務狀況。Bing,請繼續。

  • Bing C. Wang - CFO

    Bing C. Wang - CFO

  • Thank you, Mark. I will provide a brief overview of our financials for the first quarter of 2023. I would like to highlight that our financials, the cash, cash equivalent and restricted cash position of Cellectis, excluding Calyxt, as of March 31, 2023, was $88 million compared to $95 million as of December 31, 2022. This difference mainly reflects $30 million of cash out, which includes $6 million of payments for R&D expenses, $4 million for SG&A suppliers, $15 million for staff costs, $4 million for our rent and taxes, $1 million of reimbursement of the PGE loan and a $23 million net cash inflow from the capital raise closed in February. This cash position is expected to be sufficient to fund selective stand-alone operations into the third quarter of 2024.

    謝謝你,馬克。我將簡要概述我們 2023 年第一季度的財務狀況。我想強調的是,截至 2023 年 3 月 31 日,我們的財務狀況、Cellectis 的現金、現金等價物和受限現金頭寸(不包括 Calyxt)為 8800 萬美元截至 2022 年 12 月 31 日,這一數字為 9500 萬美元。這一差異主要反映了 3000 萬美元的現金支出,其中包括 600 萬美元的研發費用、400 萬美元的 SG&A 供應商費用、1500 萬美元的員工成本、400 萬美元的租金和稅費、PGE 貸款償還 100 萬美元以及資本籌集帶來的 2300 萬美元淨現金流入於 2 月份結束。預計這一現金狀況將足以為 2024 年第三季度的選擇性獨立業務提供資金。

  • On January 13, 2023, Calyxt, Cibus and certain other parties entered into a merger agreement pursuant to which Calyxt and Cibus will merge in an all-stock transaction. Following the closing of the proposed Calyxt merger, Cellectis S.A. is expected to own approximately 2.4% of the equity interest of the combined company.

    2023 年 1 月 13 日,Calyxt、Cibus 和某些其他方簽訂了合併協議,根據該協議,Calyxt 和 Cibus 將通過全股票交易進行合併。在擬議的 Calyxt 合併完成後,Cellectis S.A. 預計將擁有合併後公司約 2.4% 的股權。

  • Accordingly, if the proposed Calyxt merger is consumed, it will result in a loss of control over Calyxt and Calyxt no longer be a consolidated subsidiary.

    因此,如果擬議的 Calyxt 合併被消耗,將導致失去對 Calyxt 的控制權,並且 Calyxt 不再是合併子公司。

  • The closing of the proposed Calyxt merger is expected in the second quarter of 2023. In this context, Calyxt is presented as discontinued operations in the financial statement for the year, 3-month period ended March 31. The net loss, excluding Calyxt was $20 million in the 3 months of 2023 compared to a loss of $28 million in the 3 months of 2022. The $0.5 million decrease in net loss between 2023 and 2022 was primarily due to a decrease of $4 million in purchases and external expense as a result of quality and manufacturing internalization, a decrease of $3 million in personnel expenses due to headcount rationalization and almost fully offset by an increase of net financial loss of $5 million due to Cytovia's convertible note loss in fair value and an increase of other operating expense of $1 million.

    擬議的 Calyxt 合併預計將於 2023 年第二季度完成。在這種情況下,Calyxt 在截至 3 月 31 日的 3 個月期間的年度財務報表中列為非持續經營業務。不包括 Calyxt 的淨虧損為 20 美元2023 年 3 個月的虧損為 100 萬美元,而 2022 年 3 個月的虧損為 2,800 萬美元。2023 年至 2022 年期間淨虧損減少 50 萬美元,主要是由於採購和外部費用減少了 400 萬美元,這是由於質量和製造內部化,由於員工人數合理化,人事費用減少了 300 萬美元,幾乎完全被 Cytovia 的可轉換票據公允價值損失導致的淨財務損失增加 500 萬美元以及其他運營費用增加 100 萬美元所抵消。

  • The net loss attributable to shareholders of Cellectis, including Calyxt, was $30 million, or $0.58 per share in the 3 months of 2023 compared to a loss of $32 million or $0.70 per share in the 3 months of 2022. This $2 million decrease in net loss between 2023 and 2022 was primarily driven by a decrease of net income from discontinued operations attributable to shareholders of Cellectis of $1 million.

    包括 Calyxt 在內的 Cellectis 股東應占淨虧損為 3000 萬美元,即 2023 年 3 個月的每股虧損 0.58 美元,而 2022 年 3 個月的虧損為 3200 萬美元,即每股虧損 0.70 美元。淨虧損減少 200 萬美元。 2023 年至 2022 年期間的虧損主要是由於歸屬於 Cellectis 股東的已終止經營業務的淨利潤減少了 100 萬美元。

  • The adjusted net loss attributable to shareholders of Cellectis, including Calyxt, which excludes noncash stock-based compensation expenses, was $28 million or $0.55 per share in the 3 months of 2023 compared to a loss of $29 million or $0.64 per share in 2022.

    2023 年 3 個月,包括 Calyxt 在內的 Cellectis 股東調整後淨虧損為 2800 萬美元,即每股 0.55 美元,而 2022 年則為虧損 2900 萬美元,即每股 0.64 美元,其中不包括非現金股票補償費用。

  • The tranche A of EUR 20 million of the credit facility we got from the European Investment Bank was received in April. We are laser-focused on spending our cash on developing our clinical candidates and operating our state-of-the-art manufacturing facility in Paris and in Raleigh.

    我們從歐洲投資銀行獲得的2000萬歐元信貸額度A部分已於4月份收到。我們專注於將現金用於開發我們的臨床候選藥物以及在巴黎和羅利運營我們最先進的製造工廠。

  • In addition, our focus on maintaining an efficient corporate infrastructure should also enable a more limited growth in G&A spend.

    此外,我們對維持高效的企業基礎設施的關注也應該使一般管理支出的增長更加有限。

  • Back to you, Andre.

    回到你身上,安德烈。

  • Andre Choulika - Co-Founder, CEO & Director

    Andre Choulika - Co-Founder, CEO & Director

  • Thank you, Bing. To close out this call, I would like to reiterate how excited we are about the continued progress of our clinical trials and the upcoming milestones for 2023. Pioneering this field, Cellectis is continuously leverages gene editing and a series of breakthrough innovation into clinical development in order to transform the lives of patients with cancer and rare genetic diseases, and we look forward to continuing this effort in the second quarter of 2023 and beyond.

    謝謝你,賓。在結束本次電話會議時,我想重申我們對臨床試驗的持續進展和 2023 年即將到來的里程碑感到非常興奮。作為這一領域的先驅,Cellectis 不斷利用基因編輯和一系列突破性創新進行臨床開發為了改變癌症和罕見遺傳病患者的生活,我們期待在 2023 年第二季度及以後繼續這一努力。

  • With that, I would like to open the call for Q&A.

    至此,我想開始問答環節。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Our first question comes from Gena Wang with Barclays.

    我們的第一個問題來自巴克萊銀行的 Gena Wang。

  • Huidong Wang - Research Analyst

    Huidong Wang - Research Analyst

  • I have 3 very quick ones. First one is UCART123. You will present data at the ASGCT. The abstract looks similar versus last ASH. So wondering what kind of new data we will see at the ASGCT.

    我有3個非常快的。第一個是UCART123。您將在 ASGCT 上展示數據。摘要看起來與上一個 ASH 相似。所以想知道我們會在 ASGCT 上看到什麼樣的新數據。

  • The second question is the UCART22 since you completed the first patient, complete 28-day dose-limiting tox period. Any additional waiting period for you in order to dose next patient? And what will be the plan for next steps?

    第二個問題是UCART22自您完成第一個患者以來,完成了28天的劑量限制毒性期。為了給下一位患者用藥,您需要額外等待一段時間嗎?下一步的計劃是什麼?

  • And lastly, very quickly for Bing. According to the cash guidance, should we expect largely flat quarter-over-quarter burn?

    最後,Bing 的速度非常快。根據現金指導,我們是否應該預期季度環比燒錢基本持平?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Gena, thank you so much for these great questions. So we'll start with Mark for the first 2 on 123 and 22 and then Bing for the financial question.

    Gena,非常感謝你提出這些好問題。因此,我們將從 Mark 開始解決 123 和 22 的前 2 個問題,然後由 Bing 解決財務問題。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Thanks, Gena, for the questions. So in regards to your first question about 123, yes, there is an oral presentation at ASGCT coming up in a couple of weeks, and it is an encore presentation of the ASH presentation in that forum. As you know, we are -- as we discussed in December, we are proceeding with enrollment in the 2-dose regimen arm and that data will be presented later when available.

    謝謝吉娜提出的問題。關於你關於 123 的第一個問題,是的,幾週後 ASGCT 上將有一個口頭演講,這是該論壇上 ASH 演講的再次演講。如您所知,正如我們在 12 月討論的那樣,我們正在繼續進行 2 劑方案組的招募,數據將在稍後提供。

  • In terms of your second question about 22, yes, there is a full DLT waiting period of 28 days between the first and second patient, but subsequent patients can be enrolled simultaneously, and we will be updating the 22 data later this year as well.

    關於你關於22的第二個問題,是的,第一個和第二個患者之間有28天的完整DLT等待期,但後續患者可以同時入組,我們也將在今年晚些時候更新22的數據。

  • Bing C. Wang - CFO

    Bing C. Wang - CFO

  • Gena, regarding the cash burn question, yes, quarter-over quarter burn should be flat for the rest of this year.

    Gena,關於現金消耗問題,是的,今年剩餘時間季度環比燒錢應該持平。

  • Operator

    Operator

  • Our next question comes from Yanan Zhu with Wells Fargo.

    我們的下一個問題來自富國銀行的朱亞楠。

  • Unidentified Analyst

    Unidentified Analyst

  • This Juan for Yanan. So back to UCART22, can you comment on how your in-house product performed compared to the previous product so far?

    此娟為延安。那麼回到 UCART22,您能否評論一下您的內部產品與之前的產品相比迄今為止的表現如何?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Great question. That would be for Mark as well.

    很好的問題。對於馬克來說也是如此。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • For the question. So yes, as you know, we are currently enrolling both in the EU and the U.S. with our completely in-house manufactured UCART22 product. And as I said from the previous question, we will be updating that data later this year.

    對於這個問題。所以,是的,如您所知,我們目前正在歐盟和美國註冊我們完全內部製造的 UCART22 產品。正如我在上一個問題中所說,我們將在今年晚些時候更新該數據。

  • Unidentified Analyst

    Unidentified Analyst

  • Got it. And another question on alemtuzumab, I wonder if you can comment on how adding alemtuzumab may affect the overall safety.

    知道了。關於阿崙單抗的另一個問題,我想知道您是否可以評論添加阿崙單抗可能如何影響整體安全性。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Sure. So as we've already presented at ASH prior 2x with the 22 product and last December with the 123 product, the alemtuzumab component of lymphodepletion is very important for allowing for sustained lymphodepletion and optimal UCART expansion and, therefore, clinical activity. And what we did show looking at the AEs that were presented for both products was that there was no significant difference in terms of safety with the use of --either with or without the use of alemtuzumab. Those are very equivalent.

    當然。因此,正如我們之前在 ASH 上展示的 22 產品和去年 12 月的 123 產品一樣,淋巴清除的阿崙單抗成分對於實現持續的淋巴清除和最佳 UCART 擴增以及臨床活性非常重要。我們通過查看這兩種產品的 AE 確實發現,無論使用或不使用阿崙單抗,在安全性方面都沒有顯著差異。這些是非常等效的。

  • Unidentified Analyst

    Unidentified Analyst

  • Got it. And last question, very quick, For the 2-dose regimen, given that some literature suggests patients, disease burden may affect the grade of CRS.

    知道了。最後一個問題,非常快,對於 2 劑量方案,鑑於一些文獻表明患者的疾病負擔可能會影響 CRS 的分級。

  • Is it the company's plan that you would adjust the dose level based on patients disease burden?

    公司計劃根據患者疾病負擔來調整劑量水平嗎?

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Yes, great question. So with the 2-dose regimen, as we discussed in December, we're started -- we began enrollment with dose level 2, which was a dose that was cleared for safety as a single-dose regimen by the Data Safety Monitoring Board for the study. And so the regimen is 2 doses of dose level 2 that are given during the study. And the hypothesis going in, obviously, is that with the second dose that will be given in a state where there is a much lower disease burden and therefore, has been shown before a much lower level of potential CRS in that situation.

    是的,很好的問題。因此,正如我們在 12 月討論的那樣,對於 2 劑量方案,我們已經開始 - 我們開始以 2 劑量級別入組,該劑量已被數據安全監測委員會清除為單劑量方案的安全性。研究。因此,方案是在研究期間給予 2 劑劑量水平 2。顯然,我們的假設是,第二劑疫苗將在疾病負擔低得多的州注射,因此,在這種情況下,潛在的 CRS 水平要低得多。

  • Operator

    Operator

  • Our next question comes from Yigal Nochomovitz from Citigroup.

    我們的下一個問題來自花旗集團的 Yigal Nochomovitz。

  • Yigal Dov Nochomovitz - Director

    Yigal Dov Nochomovitz - Director

  • Just a few questions. Could you just comment on the level of enthusiasm for enrolling the UCART20x22 program, please?

    只是幾個問題。您能否簡單評價一下報名 UCART20x22 項目的熱情程度?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Mark?

    標記?

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Sure. Thanks Yigal, for the question. So there is an extreme enthusiasm for this study from all the investigators that have the study opened so far. They're very excited to proceed with this dual allogeneic CART-T cell and in particular, because it does not involve CD19, so it's out of the 19 space.

    當然。謝謝伊格爾的提問。因此,迄今為止所有開展這項研究的研究人員都對這項研究抱有極大的熱情。他們非常興奮能夠繼續研究這種雙同種異體 CART-T 細胞,特別是因為它不涉及 CD19,所以它不在 19 空間之內。

  • Yigal Dov Nochomovitz - Director

    Yigal Dov Nochomovitz - Director

  • Okay. And then you mentioned for UCART22, you completed the 28-day TLC period. Can you comment any further on the safety that was observed in that initial period?

    好的。然後您提到對於 UCART22,您完成了 28 天的 TLC 期。您能否對最初階段觀察到的安全性做進一步評論?

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Yes. So for -- as we said, for the 22, there will be a data update later this year about the patients enrolled with the P2 that we will disclose at that time.

    是的。因此,正如我們所說,對於 22 人,今年晚些時候將有關於參加 P2 的患者的數據更新,我們將在那時披露。

  • Yigal Dov Nochomovitz - Director

    Yigal Dov Nochomovitz - Director

  • Okay. And then with regard to MELANI-01, is the reason for that because you just had difficulty competing with the BCMA bispecifics Is that right? Or is there a different...

    好的。那麼關於 MELANI-01,原因是因為你很難與 BCMA 雙特異性抗體競爭,對嗎?或者有什麼不一樣的...

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Yes. Thanks, Yigal. Andre, do you want to take this one first?

    是的。謝謝,伊格爾。安德烈,你想先拿這個嗎?

  • Andre Choulika - Co-Founder, CEO & Director

    Andre Choulika - Co-Founder, CEO & Director

  • Yigel, yes, It's a definitely the competition between all the called out that are currently in either approved or in clinical development makes our enrollment very difficult. And what we're getting currently in the trial are patients, as we've shown in the past with multiple lines of treatment. And also we need to remanufacture the product that addition to the current product that we were using was essentially manufactured at (inaudible), and we think that it's essential to manufacture ourselves pro logs. We see it with 22 and 20x22, it makes a huge difference. And so the arbitration has -- like either you open more sites and probably outside the United States or -- and you can get the thing going or you try to focus and focus has been choice in the current conditions, given the drive we have for 22 and 20x22 and ofcourse 123.

    Yigel,是的,這絕對是目前正在批准或處於臨床開發階段的所有被召集者之間的競爭,這使得我們的註冊非常困難。正如我們過去通過多種治療方法所展示的那樣,我們目前在試驗中得到的是患者。此外,我們還需要重新製造除我們正在使用的當前產品之外基本上是在(聽不清)製造的產品,我們認為有必要製造我們自己的原木。我們在 22 和 20x22 中看到它,它產生了巨大的差異。因此,仲裁已經——就像你打開更多站點,可能在美國境外,或者——你可以讓事情繼續下去,或者你嘗試集中精力,考慮到我們的動力,集中精力是當前條件下的選擇22 和 20x22,當然還有 123。

  • Operator

    Operator

  • Our next question comes from Salveen Richter with Goldman Sachs.

    我們的下一個問題來自高盛的 Salveen Richter。

  • Anoumid Vaziri - Research Analyst

    Anoumid Vaziri - Research Analyst

  • This is Anoumid on for Salveen. Just another question on the CS1 program. do you anticipate bringing it back at some point given the opportunity for a non BCMA-targeted CAR-T in the multiple myeloma space. And then of the -- are there any patients that have been dosed already from this program? And would we see data from those patients? And then just a quick follow-up on CD20x22. I guess are you targeting mostly the CD19 naive or CD19 relapse patients? And then in that context, what clinical profile are you looking to achieve relative to the approved CD19 therapies or ALLO CD19 program?

    這是薩爾文的阿努米德。關於 CS1 計劃的另一個問題。鑑於多發性骨髓瘤領域有非 BCMA 靶向 CAR-T 的機會,您是否預計在某個時候將其重新推出?然後,是否有任何患者已經從該計劃中接受了給藥?我們會看到這些患者的數據嗎?然後是 CD20x22 的快速跟進。我猜你們主要針對的是 CD19 初治患者或 CD19 復發患者嗎?那麼在這種情況下,相對於已批准的 CD19 療法或 ALLO CD19 計劃,您希望實現什麼臨床特徵?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Anoumid. Thank you very much for the question. I'll leave the first question on CS1 to Andre and then Mark for 2022.

    阿努米德。非常感謝你的提問。我會將有關 CS1 的第一個問題留給 Andre,然後將 2022 年的問題留給 Mark。

  • Andre Choulika - Co-Founder, CEO & Director

    Andre Choulika - Co-Founder, CEO & Director

  • Yes, thank you very much for the question. Well, we really like the target CS1, and we believe it's a very interesting alternative to BCMA. We've already presented data in the past, and we showed that UCARTCS1 can provide like meaningful tumor reduction and like had some patient that went into -- it's not a CR because like the M-protein is still quite high, but than VGPR, so Mark will correct me concerning this, but we definitely think that it's a great target. And for us it's something that has been an arbitration that we really needed to do. And I think that it's healthy for the company. But of course, if we have the potential to change the course of this, especially if we have like the means to do it, we would definitely restart it as we believe that CS1 is a huge alternative to BCMA and all multiple myeloma current product that are developed. It's a validated target with alemtuzumab, and it's Self-lymphodepleting. So it's great in its own space.

    是的,非常感謝你的提問。嗯,我們真的很喜歡目標 CS1,並且我們相信它是 BCMA 的一個非常有趣的替代品。我們過去已經提供過數據,我們表明 UCARTCS1 可以提供有意義的腫瘤減少,就像一些患者進入的那樣——這不是 CR,因為 M 蛋白仍然相當高,但比 VGPR,所以馬克會糾正我的這一點,但我們絕對認為這是一個很好的目標。對我們來說,這是我們真正需要做的仲裁。我認為這對公司來說是健康的。但當然,如果我們有潛力改變這一進程,特別是如果我們有辦法做到這一點,我們肯定會重新啟動它,因為我們相信 CS1 是 BCMA 和所有多發性骨髓瘤當前產品的巨大替代品。已開發。它是經過阿崙單抗驗證的靶標,並且具有自我淋巴細胞清除功能。所以它在自己的空間裡很棒。

  • So there's a lot of features that are extremely interesting, but you have to remain factor the product internally given the performance of our group currently, and this is something we would like to focus on the current driver in the company, which are 22, 20x 22 and 123. Mark?

    因此,有很多非常有趣的功能,但考慮到我們團隊目前的表現,您必須在內部保留產品的因素,這是我們希望關注公司當前驅動程序的內容,即 22、20 倍22和123。馬克?

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Okay. Thanks, Andre. So -- and I'll go to the 20x22 question. So yes, so patients that have had prior CD19-directed therapy of any variety are eligible for this study. And in addition, patients that obviously could not receive CD19-directed therapy for 1 reason or another are also eligible for this study.

    好的。謝謝,安德烈。那麼——我將討論 20x22 問題。所以是的,之前接受過任何類型的 CD19 定向治療的患者都有資格參加這項研究。此外,由於某種原因明顯無法接受 CD19 定向治療的患者也有資格參加這項研究。

  • Anoumid Vaziri - Research Analyst

    Anoumid Vaziri - Research Analyst

  • And just a follow-up, what target profile are you hoping to achieve with this program?

    接下來,您希望通過該計劃實現什麼目標?

  • Bing C. Wang - CFO

    Bing C. Wang - CFO

  • Right now, it would be considered as an additional line past CD19-directed therapy.

    目前,它被認為是 CD19 定向療法之後的一條附加線。

  • Operator

    Operator

  • Our next question comes from Kelly Shi with Jefferies.

    我們的下一個問題來自 Jefferies 的 Kelly Shi。

  • Dev Prasad - Equity Associate

    Dev Prasad - Equity Associate

  • This is Dev on for Kelly Shi. I have a couple of questions. One is, you mentioned runway into third quarter of '24. I just wanted to make sure, does it include any milestone payments. Also, any thoughts on doing 2- dose regimen for UCART22?

    這是凱莉·施 (Kelly Shi) 的開發人員。我有一些問題。一是,你提到了 24 年第三季度的進展。我只是想確定一下,它是否包括任何里程碑付款。另外,對於 UCART22 進行 2 劑量方案有什麼想法嗎?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Thank you for the question. So Bing for the runway and then Mark, for the 2-dose regimen on 22.

    感謝你的提問。因此,Bing 參加了跑道,然後 Mark 參加了 22 日的 2 劑治療方案。

  • Bing C. Wang - CFO

    Bing C. Wang - CFO

  • Yes, we've included some probability adjusted I would say, pretty conservative on our part on the milestone to provide that runway guidance to third quarter of 2024.

    是的,我想說,我們已經對概率進行了一些調整,對於提供到 2024 年第三季度的跑道指南的里程碑來說,我們相當保守。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • And then for the second question about 22. So right now, the trial is structured obviously as a single-dose regimen, which we will continue to evaluate as we move forward.

    然後是關於 22 的第二個問題。所以現在,試驗的結構顯然是單劑量方案,我們將在前進過程中繼續評估。

  • Operator

    Operator

  • Our next question comes from Hartaj Singh with Oppenheimer.

    我們的下一個問題來自哈塔吉·辛格和奧本海默。

  • Hartaj Singh - Research Analyst

    Hartaj Singh - Research Analyst

  • Good to hear everybody's voice. I just want to ask a more holistic question, maybe just stepping back. You had mentioned previously that I believe it's for BALLI-01, the patients would be post autologous CAR-T and stem cell therapy. And correct me if I'm wrong. Can you give us an idea for BALLI, and I think you mentioned this for AMELI and then for NAtHaLI. What line of patients generally are you recruiting for these studies right now? And then secondly, I assume you have ongoing discussions with regulators. If you get to a recommended Phase II dose. Can you just kind of walk us through quickly what sort of dose expansion trials could we look forward to in these? I know that could be -- there might be some hypotheticals there, but it would be nice to get an idea.

    很高興聽到大家的聲音。我只是想問一個更全面的問題,也許只是退一步。您之前提到過,我相信這是針對 BALLI-01 的,患者將接受自體 CAR-T 和乾細胞治療。如果我錯了,請糾正我。您能給我們介紹一下 BALLI 的想法嗎?我想您在 AMELI 和 NAtHaLI 中都提到過這一點。您現在一般正在招募哪類患者進行這些研究?其次,我認為您正在與監管機構進行討論。如果您達到推薦的 II 期劑量。您能否快速向我們介紹一下我們可以期待哪些類型的劑量擴展試驗?我知道這可能是——可能有一些假設,但如果能得到一個想法那就太好了。

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Thank you, Hartaj, for the questions, and I'll give them to Mark.

    謝謝哈塔吉提出的問題,我會將這些問題轉交給馬克。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Thanks, Hartaj. Good to hear you. In terms of the first question in terms of the studies. What we did -- these patients are all heavily, heavily pretreated. And so what we've disclosed for '22 from the obvious prior to ASH, where we presented a lot of these patients fail 19-directed therapy at least some blinatumomab, some blinatumomab CD19 autologous CART-T cells as well as inotuzumab as well as allogeneic stem cell transplant.

    謝謝,哈塔傑。很高興聽到你的聲音。關於第一個問題,就研究而言。我們所做的——這些患者都接受了大量的預處理。因此,我們在 ASH 之前就已經公開了 22 年的情況,其中我們介紹了許多患者在 19 定向治療中失敗,至少有一些 blinatumomab、一些 blinatumomab CD19 自體 CART-T 細胞以及 inotuzumab 以及同種異體幹細胞移植。

  • So they really truly really have no other treatment options for a lot of these patients due to all the lines of therapy that they failed.

    因此,由於所有治療方案都失敗了,對於許多患者來說,他們真的沒有其他治療選擇。

  • For 123, it's very similar because AML, as you know, very aggressive, very refractory in these patients once they relapse and they fail multiple different chemotherapeutic regimens, some small molecule targeted regimens and almost greater than almost 3 quarters, 2/3 to 3/4 have failed an allogeneic stem cell transplant and those that haven't failed to transplant have been such that they've been refractory and haven't had a significant response to even go on to transplant.

    對於 123 來說,情況非常相似,因為如您所知,AML 非常具有侵襲性,一旦復發,這些患者就非常難治,並且多種不同的化療方案、一些小分子靶向方案均失敗,幾乎超過四分之三,2/3 至 3 /4 的同種異體幹細胞移植失敗了,而那些沒有移植失敗的人則表現出難治性,甚至沒有明顯的反應來繼續移植。

  • So again, this is the kind of heavily pretreated patients we're seeing for 123, as we presented before. And with 22 -- 20x22, as we just discussed, again, these are going to be patients that are going to be heavily pretreated, and they will be an additional line at least and if 1 additional line beyond their first CD19-directed therapy.

    再說一次,正如我們之前介紹的那樣,這就是我們在 123 中看到的那種經過大量預處理的患者。對於 22 - 20x22,正如我們剛剛討論的那樣,這些患者將接受大量預處理,他們將至少是一個額外的線,如果在他們的第一個 CD19 定向治療之外還有一個額外的線。

  • In terms of your second question, again, this is stuff that's currently being discussed with the regulators. What we have what we have disclosed, obviously, the ALL study will be open to young adults and older adults and down to the age of 12 once we get into expansion from the pediatric perspective. For 123, it's obviously right now, it's adults 18 to 65. And for 20x22, it's also in the adult space, but we are with 18 to 80. And currently, as we've discussed, the logical first expansion cohort is in the large B-cell lymphoma space due to the -- just due to the incidents, the high incidents.

    關於你的第二個問題,這也是目前監管機構正在討論的問題。根據我們所披露的情況,顯然,一旦我們從兒科角度進行擴展,ALL 研究將向年輕人和老年人開放,直至 12 歲。對於 123,顯然現在是 18 至 65 歲的成年人。對於 20x22,它也在成人空間,但我們是在 18 至 80 歲。目前,正如我們所討論的,邏輯上的第一個擴展隊列是在大 B 細胞淋巴瘤空間由於——只是由於事件,高事件。

  • Operator

    Operator

  • Our next question comes from Jack Allen with Baird.

    我們的下一個問題來自傑克·艾倫和貝爾德。

  • Jack Kilgannon Allen - Senior Research Analyst

    Jack Kilgannon Allen - Senior Research Analyst

  • Congratulations on the whole progress in the quarter. I guess the first question, I just wanted to confirm, you mentioned the ASGCT presentation of the AML data will be an encore presentation. Will there be any additional follow-up of patients in that presentation? Or will it just be more of an encore as it relates to ASH.

    祝賀本季度的整體進展。我想第一個問題,我只是想確認一下,您提到 AML 數據的 ASGCT 演示將是一次再演演示。該演示中是否會對患者進行任何額外的隨訪?或者它只是更多與 ASH 相關的加演。

  • And then as it relates to 20x22, you've made a few comments that you're enrolling patients in the study, but I was wondering if you could provide some additional thoughts around the dose levels that you've reached and what we should think about as it relates to data readouts as we move through the year from the 2022 program.

    然後,由於它與 20x22 相關,您發表了一些評論,表示您正在招募患者參加研究,但我想知道您是否可以就您已達到的劑量水平以及我們應該考慮的問題提供一些額外的想法大約因為它與我們從 2022 年計劃開始的一年中的數據讀出有關。

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Jack, thank you so much, and these are great questions for Mark.

    傑克,非常感謝你,這些對馬克來說都是很好的問題。

  • Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

    Mark Frattini - Senior VP of Clinical Sciences & Chief Medical Officer

  • Thanks for your question. So yes, in terms of the ASGCT, oral for 123, it will be an encore of the ASH presentation with the data cutoff used for ASH.

    謝謝你的提問。所以,是的,就 ASGCT 而言,口頭 123,這將是 ASH 演示的重演,並使用 ASH 的數據截止。

  • For 20x22, as we've discussed before, we expect to disclose first in -- first-in-human data for this study later this year. So we'll go through the first patients that have been treated.

    對於 20x22,正如我們之前討論過的,我們預計將在今年晚些時候首次披露這項研究的首次人體數據。因此,我們將檢查第一批接受治療的患者。

  • Operator

    Operator

  • Our next question comes from Silvan Tuerkcan with JMP Securities.

    我們的下一個問題來自 JMP 證券的 Silvan Tuerkcan。

  • Silvan Can Tuerkcan - Director and Equity Research Analyst

    Silvan Can Tuerkcan - Director and Equity Research Analyst

  • I have a question about your manufacturing capabilities. So clearly, you can manufacture fully in-house in the U.S. and in Europe at this point. Are there any access capacities that you could potentially monetize in the short term? Or will you -- do you just plan to fully use that for yourself?

    我有一個關於你們製造能力的問題。顯然,此時您可以在美國和歐洲完全內部製造。是否存在可以在短期內獲利的訪問能力?或者你會——你只是打算完全為自己使用它嗎?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Sean, great question. And I think the one would be for Andre.

    肖恩,好問題。我認為這個人應該是給安德烈的。

  • Andre Choulika - Co-Founder, CEO & Director

    Andre Choulika - Co-Founder, CEO & Director

  • Well, first of all, we're extremely proud of our manufacturing capacities. And I think that it was blessing that the strategy that we did took initially, it was like before COVID to integrate all the chain of manufacturing means like from Buffers to DNA to RLDs to the final product even for commercial that has been internalized and the (inaudible) To more to more internalizing things. And I don't know in which position we would be if we wouldn't have taken this decision previously. The second thing that we're excited about is this year, as Mark is saying, since the beginning of the call, is present you the data with the total that has been manufactured internally in the performance of our manufacturing.

    首先,我們對我們的製造能力感到非常自豪。我認為我們最初採取的策略是值得慶幸的,就像在新冠疫情之前一樣,整合了所有製造手段鏈,例如從緩衝區到 DNA、RLD 到最終產品,甚至對於已經內部化的商業產品也是如此(聽不清)更多更多的內化事物。我不知道如果我們之前沒有做出這個決定,我們會處於什麼境地。我們感到興奮的第二件事是今年,正如馬克所說,自電話會議開始以來,我們向您提供了我們製造績效中內部製造的總量數據。

  • Now if this manufacturing is essentially for internal use, we're always open to manufacture for our partners. But Cellectis is not positioned itself as a potential CMO, and this is not our business, and there is like an offer that is driven by a series of CMOs outside.

    現在,如果這種製造基本上供內部使用,我們始終願意為我們的合作夥伴製造。但Cellectis並沒有將自己定位為潛在的CMO,這也不是我們的業務,而有一個報價是由外部一系列CMO推動的。

  • Now if there's a potential to monetize this, there's always -- this option is always open, but we don't think that it's something that must be discussed today because the opportunity of this, but it's definitely an asset that Cellectis has and it's a very strong asset that we would like to keep internal so far. I think that makes a big difference and there's 2 categories of cellular and gene therapy companies, the one that know how to manufacture the (inaudible) and the others and Cellectis this is among the first capability that I think would distinguish themselves.

    現在,如果有潛力將其貨幣化,那麼這個選項總是開放的,但我們認為今天不必討論這個問題,因為這是一個機會,但這絕對是 Cellectis 擁有的一項資產,它是一個迄今為止我們希望將其保留在內部的非常強大的資產。我認為這有很大的不同,有兩類細胞和基因治療公司,一類知道如何製造(聽不清),另一類是 Cellectis,這是我認為能夠脫穎而出的第一個能力。

  • Operator

    Operator

  • Our next question comes from Ingrid Gafanhão with Kempen.

    我們的下一個問題來自 Ingrid Gafanhão 和 Kempen。

  • Ingrid Gafanhão - Former Research Analyst

    Ingrid Gafanhão - Former Research Analyst

  • I have 2 questions, if I may. So the first one, you mentioned that you have changed the trade name of alemtuzumab with no context of your trials. Can you just remind us how the regulatory landscape might look like? Do you have to -- alemtuzumab is a approved product? Is that enough for the agencies? Or do you have to do something in parallel to get this approved as lymphodepletion regimen together with yourselves.

    如果可以的話,我有兩個問題。第一個,您提到您已經更改了阿崙單抗的商品名,但沒有提及您的試驗背景。您能否提醒我們監管環境會是什麼樣子?您是否必須——阿崙單抗是已批准的產品?對於機構來說這足夠了嗎?或者您是否必須同時做一些事情才能與您自己一起獲得批准作為淋巴清除方案。

  • And my second question is regarding the next EIB, the tranche from the EIB loan. When do you roughly expect time-wise to have access to that one?

    我的第二個問題是關於下一個歐洲投資銀行的貸款,即歐洲投資銀行貸款的一部分。您大致預計什麼時候可以訪問該內容?

  • Arthur Stril - Chief Business Officer

    Arthur Stril - Chief Business Officer

  • Okay. Thank you, Ingrid. And maybe I can speak a little bit about the alemtuzumab given the partnership that we have with Sanofi and then hand it over to Bing for the EIB.

    好的。謝謝你,英格麗德。鑑於我們與賽諾菲的合作關係,也許我可以談談阿崙單抗,然後將其交給 EIB 的 Bing。

  • So you're absolutely right. And in 2021, we signed a strong partnership with Sanofi on the supply of alemtuzumab. And as you know, alemtuzumab is already an approved product in other indications. So we definitely expect to leverage that and the agency's familiarity with that product. Of course, we'll have to demonstrate that the importance of alemtuzumab in our CAR-T trials which, as Mark has highlighted, we have already done and disclosed data for UCART123 and UCART22. But we definitely expect that through our partnership with Sanofi and the agency's prior familiarity with alemtuzumab, the approach will be streamlined as opposed to a completely novel agent.

    所以你是完全正確的。 2021年,我們與賽諾菲就阿崙單抗的供應簽署了強有力的合作夥伴關係。如您所知,阿崙單抗已經是其他適應症的批准產品。因此,我們肯定希望利用這一點以及該機構對該產品的熟悉程度。當然,我們必須證明阿崙單抗在我們的 CAR-T 試驗中的重要性,正如 Mark 強調的那樣,我們已經完成並披露了 UCART123 和 UCART22 的數據。但我們肯定希望通過與賽諾菲的合作以及該機構之前對阿崙單抗的熟悉,該方法將得到簡化,而不是完全新穎的藥物。

  • And Bing for the EIB.

    以及 EIB 的 Bing。

  • Bing C. Wang - CFO

    Bing C. Wang - CFO

  • Great. Thank you, Ingrid, for the question. So first of all, I also want to highlight, and there was a question earlier on the cash runway, is the cash balance that we reported for Q1 does not include the EUR 20 million tranche A of the EIB cash that came in because that came in April. So that EUR 20 million is not reflected in Q1 cash balance, and that's in tranche A.

    偉大的。謝謝英格麗德的提問。首先,我還想強調,早些時候關於現金跑道的問題是,我們報告的第一季度現金餘額不包括歐洲投資銀行現金的 2000 萬歐元 A 部分,因為那是在四月份。因此,2000 萬歐元沒有反映在第一季度現金餘額中,而是在 A 部分中。

  • And your question regarding tranche B, we have already satisfied the financial precedent conditions for Tranche B, which is as a result of our equity raise in February and also as a result of the EUR 50 million milestone payment that came in December of 2022.

    至於你關於 B 部分的問題,我們已經滿足了 B 部分的財務先決條件,這是我們 2 月份股權融資的結果,也是 2022 年 12 月支付 5000 萬歐元里程碑付款的結果。

  • Now when do we plan to draw on, depends on when we plan to issue the warrants for the necessary drawdown of the tranche B, which is EUR 15 million. And that, we have not made a decision at this point, but I just want to highlight that we have satisfied the present condition to draw on this EUR 15 million.

    現在,我們計劃何時動用,取決於我們計劃何時發行 B 部分必要提取的認股權證,即 1500 萬歐元。而且,我們目前尚未做出決定,但我只想強調,我們已經滿足了動用這 1500 萬歐元的現有條件。

  • Ingrid Gafanhão - Former Research Analyst

    Ingrid Gafanhão - Former Research Analyst

  • Great. And if I may ask a follow-up. So your current cash guidance somewhat risk-adjusted you're taking into account what you have acquisitions in exchange or is that not in your current plan?

    偉大的。我可以詢問後續情況嗎?因此,您當前的現金指導在一定程度上進行了風險調整,您正在考慮您所交換的收購內容,或者這不在您當前的計劃中?

  • Bing C. Wang - CFO

    Bing C. Wang - CFO

  • So our cash guidance for the third quarter of 2024 assumes that we will draw down on Tranche B of the European Investment Bank loan.

    因此,我們對 2024 年第三季度的現金指導假設我們將提取歐洲投資銀行貸款的 B 部分。

  • Operator

    Operator

  • We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Mr. Choulika for closing comments.

    我們的問答環節已經結束。我現在想請 Choulika 先生髮表總結意見。

  • Andre Choulika - Co-Founder, CEO & Director

    Andre Choulika - Co-Founder, CEO & Director

  • Well, thank you, everyone, for attending this earnings call. We're extremely proud of what has been achieved so far we think that 2023 and the next 12 to 18 months are going to be extremely rich, as been described in this presentation, like event range for the company, and we're very excited by the product we're developing. We think that the company is focused more than ever on its resources and great product that we're developing, and we'll look forward for the next update.

    好的,謝謝大家參加這次財報電話會議。我們對迄今為止所取得的成就感到非常自豪,我們認為 2023 年和未來 12 到 18 個月將非常豐富,如本演示文稿中所述,例如公司的活動範圍,我們非常興奮通過我們正在開發的產品。我們認為該公司比以往任何時候都更加關注其資源和我們正在開發的出色產品,我們將期待下一次更新。

  • Thank you very much, and wish you a great day.

    非常感謝您,祝您有美好的一天。

  • Operator

    Operator

  • This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

    今天的會議到此結束。此時您可以斷開線路。感謝您的參與。