Cellectis SA (CLLS) 2023 Q3 法說會逐字稿

Good morning, everyone, and welcome to the Cellectis third quarter 2023 earnings calls. (Operator Instructions) Please be aware that today's conference call is being recorded.

大家早安，歡迎參加 Cellectis 2023 年第三季財報電話會議。 （操作員說明）請注意，今天的電話會議正在錄音。

I'd now like to introduce the first speaker Arthur Stril, Chief Business Officer. You may begin.

現在我想介紹第一位發言人 Arthur Stril，他是首席商務長。你可以開始了。

Good morning, and welcome, everyone, to Cellectis third quarter 2023 corporate update and financial results conference call. 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.

早安，歡迎大家參加 Cellectis 2023 年第三季公司更新與財務業績電話會議。今天與我一起參加電話會議並發表準備好的演講的是我們的執行長安德烈·喬利卡 (Andre Choulika) 博士；王兵博士，我們的財務長；以及我們的首席醫療官 Mark Frattini 博士。

Yesterday evening, Cellectis issued a press release reporting a corporate and business update for the third quarter 2023 and its financial results for the nine- month period ended September 30, 2023.

昨天晚上，Cellectis 發布了一份新聞稿，報告了 2023 年第三季的公司和業務更新以及截至 2023 年 9 月 30 日的九個月期間的財務業績。

As a reminder, we will make statements regarding Celectis financial outlook, including the sufficiency of cash from operations in addition to its manufacturing, regulatory and product development status and plan and product development of its license partners.

謹此提醒，我們將就 Celectis 的財務前景發表聲明，包括來自營運的充足現金，以及其製造、監管和產品開發狀況以及其許可合作夥伴的計劃和產品開發。

These forward statements, which are based on management's current expectations, and assumption 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.

這些前瞻性陳述基於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。

A description of these risks can be found in our most recent Form 20F filed with the Securities and Exchange Commission SEC and the financial report including the management report for the ended on December 31, 2022, and subsequent filing Cellectis makes with the SEC from time to time.

這些風險的描述可以在我們最近向美國證券交易委員會 SEC 提交的 20F 表格以及截至 2022 年 12 月 31 日的財務報告（包括管理報告）以及 Cellectis 不時向 SEC 提交的後續文件中找到。時間。

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

我現在想把電話轉給安德烈。

Thank you, Arthur, and good morning, and thank you, everyone, for joining us today. Last week, we announced a strategic collaboration and investment agreement with AstraZeneca.

謝謝你，亞瑟，早安，謝謝大家今天加入我們。上週，我們宣布與阿斯特捷利康達成策略合作和投資協議。

We are very proud to initiate this partnership with one of the top leaders in the pharma space, pairing our strong commitment and ambition cell and gene therapy, AstraZeneca, because we have been very much impressed by the long term strategy in this space. Backed by a strong commitment and development already made paving the way powered by top leadership in this arena.

我們非常自豪能夠與製藥領域的頂級領導者之一建立這種合作夥伴關係，將我們堅定的承諾和雄心壯志與細胞和基因治療阿斯特捷利康相結合，因為我們對該領域的長期戰略印象深刻。以堅定的承諾和發展為後盾，在這一領域的高層領導的推動下已經鋪平了道路。

We strongly believe that together since AstraZeneca, that next generation of genomic medicine will be developed under our collaboration will revolutionize medicine across a number of therapeutic areas in the years to come.

我們堅信，自阿斯特捷利康以來，我們合作開發的下一代基因組醫學將在未來幾年徹底改變多個治療領域的醫學。

Part of our agreement, AstraZeneca has agreed to make an initial payment of $105 million to select composed of $80 million equity investment in exchange of $16 million ordinary shares at $5 per share. $25 million upfront payment under the research collaboration agreement. Cellectis is also eligible to receive an additional $140 million equity investment in exchange for $28 million convertible preferred shares at $5 per share, subject to Cellectis shareholders' approval and several other condition of closing.

根據我們協議的一部分，阿斯特捷利康同意向 Select 支付 1.05 億美元的首期付款，其中包括 8,000 萬美元的股權投資，以每股 5 美元的價格換取 1,600 萬美元的普通股。根據研究合作協議預付款 2500 萬美元。 Cellectis 還有資格獲得額外 1.4 億美元的股權投資，以每股 5 美元的價格換取 2,800 萬美元的可轉換優先股，但須經 Cellectis 股東批准並滿足其他幾項交割條件。

Now some words about the research collaboration. It's a very ambitious proposal to develop novel cell and gene therapies across oncology, immunology and rare diseases. We have exclusively reserved 25 genetic targets for AstraZeneca from which up to 10 novel candidate product could be explored for development.

現在談談研究合作。這是一個非常雄心勃勃的提議，旨在開發跨腫瘤學、免疫學和罕見疾病的新型細胞和基因療法。我們為阿斯特捷利康獨家保留了25個基因靶點，從中可以探索開發多達10種新的候選產品。

The beauty of this agreement is that our clinical stage assets UCART22, UCART123, and UCART20x22 remain under our own ownership and control. And you should expect regular updates in the advancement of this program for us.

該協議的優點在於，我們的臨床階段資產 UCART22、UCART123 和 UCART20x22 仍由我們自己擁有和控制。您應該期待我們定期更新該計劃的進展。

Within the collaboration, we will leverage our cutting edge innovation and best-in-class manufacturing capability. Develop new disruptive product candidate and AstraZeneca will have an option for a worldwide exclusive license on 10 of the candidate products exercise before IND filings

在合作中，我們將利用我們的尖端創新和一流的製造能力。開發新的顛覆性候選產品，阿斯特捷利康將可以選擇在 IND 申請前獲得 10 種候選產品的全球獨家許可

Our research costs under the collaboration will be funded by AstraZeneca and we're eligible to receive an IND option key and development, regulatory and sales- related milestone payments ranging from $70 million and up to $220 million, per each of the 10 candidate products, plus tiered royalties.

我們在合作下的研究費用將由阿斯特捷利康資助，我們有資格獲得IND 選項金鑰以及開發、監管和銷售相關的里程碑付款，每10 種候選產品的每一種從7000 萬美元到2.2 億美元不等，加上分級特許權使用費。

We're very excited to get to work with AstraZeneca to leverage our capabilities and build the next-generation of genomic medicines to address areas of high unmet patient need together.

我們非常高興能夠與阿斯特捷利康合作，利用我們的能力，開發下一代基因組藥物，共同解決患者需求未被滿足的領域。

During this past third quarter Cellectis innovation key excelled in releasing disruptive preclinical data on gene editing of [Hematopoietic] stem cell gene therapy for an immunological disease. Later, on our proprietary power base editing technology and multi armored allogenic CAR-T cell targeting MUC1 for triple negative breast cancer, demonstrating one more time to spend and the power of our gene-editing platform and to develop next-generation cell and gene therapies for patients with unmet medical need.

在過去的第三季度，Cellectis 的創新關鍵在於發布了針對免疫性疾病的[造血]幹細胞基因療法的基因編輯的破壞性臨床前數據。隨後，我們透過專有的Power Base 編輯技術和針對MUC1 的多裝甲同種異體CAR-T 細胞治療三陰性乳癌，展示了我們的基因編輯平台的力量以及開發下一代細胞和基因療法的更多時間對於醫療需求未被滿足的患者。

In addition, our clinical team will be presenting update of results for the Phase 1, BALLI-01 trial of UCART22 and preliminary results of the NATHALI-01 trial evaluating UCART20x22 in relapsed or refractory B-Cell Non-Hodgkin's Lymphoma at the American Association, the Hematology Annual Meeting.

此外，我們的臨床團隊將在美國協會介紹 UCART22 的 1 期 BALLI-01 試驗的最新結果以及評估 UCART20x22 治療復發或難治性 B 細胞非霍奇金淋巴瘤的 NETHALI-01 試驗的初步結果，血液學年會。

But I will let Mark in a couple of minutes talk about these abstracts. However one thing I would like to highlight in what Mark is going to present after, is the importance of the know-how in manufacturing. In cell therapeutics nothing is more important but the fitness of the cell that will be injected to patients.

但我會讓馬克在幾分鐘內談論這些摘要。然而，我想在馬克接下來的演講中強調一件事，那就是製造技術的重要性。在細胞療法中，沒有什麼比注射給患者的細胞的適應性更重要的了。

The quality, the reproducibility of manufacturing is one of the game changer in the success of these therapies, which is why we have fully internalized manufacturing. Now this work is totally completed and this is why it's going to make a difference.

製造的品質和可重複性是這些療法成功的遊戲規則改變者之一，這就是我們完全內部化製造的原因。現在這項工作已經完全完成，這就是為什麼它會有所作為。

So like this will continue to control strictly cash burn within these difficult market environment. And we will continue to focus our efforts and expenses on advancing our core clinical trial BALLI-01 evaluating UCART22. NATHALI-01 evaluating UCART20x22, and AMELI-01 evaluating UCART123

因此，在困難的市場環境下，我們將繼續嚴格控制現金消耗。我們將繼續將精力和費用集中在推進評估 UCART22 的核心臨床試驗 BALLI-01 上。 NETHALI-01 評估 UCART20x22，AMELI-01 評估 UCART123

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

因此，我想將電話轉給我們的首席醫療官 Mark Frattini 博士，他將概述這些臨床試驗。

Mark, please go ahead.

馬克，請繼續。

Thank you, Andre, we will be presenting updated results of the Phase 1, BALLI-01 trial of UCART22 in relapsed or refractory acute leukemia. And preliminary results for the NATHALI-01 trial evaluating UCART20x22 in relapsed or refractory B-Cell Non-Hodgkin's Lymphoma at the American Association of Hematology 65th annual meeting in December.

謝謝你，Andre，我們將介紹 UCART22 治療復發或難治性急性白血病 1 期 BALLI-01 試驗的最新結果。 12 月在美國血液學協會第 65 屆年會上評估 UCART20x22 治療復發或難治性 B 細胞非何杰金氏淋巴瘤的 NATHALI-01 試驗的初步結果。

As Andre just mention regarding our clinical trial, BALLI-01 evaluating UCART22 and relapsed or refractory B-cell ALL. We have a comparison between a product manufactured at a CDMO, this is process 1. And the same product manufactured in house here at Cellectis, this is process 2.

正如 Andre 剛剛提到的我們的臨床試驗，BALLI-01 評估 UCART22 和復發或難治性 B 細胞 ALL。我們對 CDMO 生產的產品（這是流程 1）和 Cellectis 內部生產的相同產品（這是流程 2）進行了比較。

In vitro comparability studies suggested that UCART22, process 2 manufactured by Cellectis biologics is is more potent than UCART22 process 1 manufactured by an outside CDMO. In June at the EHA Congress, we showed you data of patients enrolled at dose level three with 5 million cells per kilogram with UCART22 using process 1. Since then and as of July 1, 2023, three patients were enrolled into the first UCART22, P2 cohort at dose level 2 at 1 million cells per kilogram.

體外可比性研究表明，Cellectis biologics 生產的 UCART22 製程 2 比外部 CDMO 生產的 UCART22 製程 1 更有效。 6 月的EHA 大會上，我們向您展示了使用流程1 以每公斤500 萬細胞的UCART22 劑量等級3 入組的患者數據。從那時起，截至2023 年7 月1 日，三名患者入組了第一個UCART22，P2劑量水準 2 的隊列，每公斤 100 萬個細胞。

UCART22, P2 was administered after fludarabine, cyclophosphamide, and alemtuzumab (FCA) lymphodepletion and was well tolerated. No dose-limiting toxicities or immune effector cell associated neurotoxicity was observed. And CRS observed was Grade 1 or 2.

UCART22，P2 在氟達拉濱、環磷酰胺和阿崙單抗 (FCA) 淋巴細胞清除後給藥，且耐受性良好。沒有觀察到劑量限制性毒性或免疫效應細胞相關的神經毒性。觀察到的CRS為1級或2級。

There was a higher preliminary response rate, 67% at dose level 2 with 1 million cells per kilogram with with UCART22 P2 compared to 50% response rate with a dose 5 times higher at dose level 3 of UCART22, P1 that was manufactured by outside CDMO.

UCART22 P2 在每公斤 100 萬個細胞的劑量水準 2 下的初步反應率較高，為 67%，而由外部 CDMO 生產的 UCART22 P1 劑量水準 3 的劑量高出 5 倍的反應率為 50% 。

UCART22 expansion was observed in the responding patients and correlated with increases in serum cytokines and inflammatory markers. The study continues to enroll patients at dose level 2i 2.5 million cells per kilograms with UCART22, P2.

在有反應的患者中觀察到 UCART22 擴增，並與血清細胞因子和發炎標記物的增加有關。研究繼續以 UCART22，P2 劑量水準 2i 250 萬個細胞/公斤入組患者。

We will also be presenting preliminary results of NATHALI-01 study, evaluating UCART20x22, the first [allergen] in a dual CAR T-cell product in patients with relapse refractory B-cell non-Hodgkin lymphoma at the ASH meeting in December. In this case UCART20x22 has been fully manufactured in-house by selective, at our raleigh manufacturing plants.

我們也將在12 月的ASH 會議上介紹NATHALI-01 研究的初步結果，該研究評估UCART20x22，這是雙CAR T 細胞產品中的第一個[過敏原]，用於治療復發難治性B 細胞非霍奇金淋巴瘤患者。在這種情況下，UCART20x22 已完全由我們的羅利製造工廠選擇性地在內部製造。

As of July 1, 2023, three patients were enrolled and treated at dose level 1. Here, we are using a flat dose of 50 million cells for patients over 50 kilograms. Cytokine release syndrome,Grade 1 or 2 occurred in all patients, and all CRS resolved with treatment. No immune effector cell associated neurotoxicity or graft versus host disease was observed. There were no UCART20x22 dose limiting toxicities and there was 1 CLLS52 or alemtuzumab.

截至 2023 年 7 月 1 日，三名患者入組並接受劑量等級 1 的治療。在這裡，我們對體重超過 50 公斤的患者使用 5000 萬個細胞的固定劑量。所有患者均出現1級或2級細胞激素釋放綜合徵，所有CRS均經治療緩解。沒有觀察到免疫效應細胞相關的神經毒性或移植物抗宿主疾病。沒有 UCART20x22 劑量限制性毒性，且有 1 個 CLLS52 或阿崙單抗。

All patients responded at day 28, with 1 partial metabolic response and 2 complete metabolic responses in patients who had failed prior autologous CD19 CAR T-cell therapies. UCART20x22 expansion correlated with increases in serum cytokine and inflammatory marker levels as well as with Cytokine release syndrome.

所有患者在第 28 天出現反應，在先前自體 CD19 CAR T 細胞療法失敗的患者中，有 1 例部分代謝反應，2 例完全代謝反應。 UCART20x22 擴增與血清細胞激素和發炎標記物水平以及細胞激素釋放症候群相關。

These initial data with the 100% responses at the initial dose of 50 million cells per per patient support the continued study of UCART20x22 in relapsed refractory B-cell NHL and the study continues to enroll.

這些初步數據在每位患者 5000 萬個細胞的初始劑量下獲得 100% 反應，支持 UCART20x22 在復發難治性 B 細胞 NHL 中的持續研究，並且該研究仍在繼續招募。

Lastly, our AMELI-01 study evaluating UCART123 in patients with relapsed or refractory acute myeloid leukemia continues to progress and enroll patients in the FCA 2 dose regimen are.

最後，我們的 AMELI-01 研究評估了 UCART123 在復發性或難治性急性髓性白血病患者中的作用，該研究仍在繼續取得進展，並將患者納入 FCA 2 劑量方案。

With that, I would like to hand the call over to Dr. Bing Wang, Celectis's Chief Financial Officer for an overview of our financials for the third quarter of 2023.

在此，我想將電話轉交給 Celectis 財務長 Bing Wang 博士，以概述我們 2023 年第三季的財務狀況。

Bing, please go ahead.

賓，請繼續。

Thank you, Mark. I would like to highlight that in our financials, the cash, cash equivalents, restricted cash position of Cellectis, excluding Caelyx, as of September 30, 2023, was $72 million compared to $95 million as of December 31, 2022.

謝謝你，馬克。我想強調的是，在我們的財務數據中，截至2023 年9 月30 日，Cellectis（不包括Caelyx）的現金、現金等價物和受限現金頭寸為7,200 萬美元，而截至2022 年12 月31 日為9500 萬美元。

This $23 million difference mainly reflects from the $79 million of cash-out, which includes $23 million for R&D, $12 million for SG&A $32 million for staff cost, $8 million for rent and taxes, $4 million of reimbursement of the PGE loan, and $2 million unfavorable impact on foreign exchange partially offset by a $23 million net cash inflow from the capital raise closed in February.

這2,300 萬美元的差異主要來自7,900 萬美元的現金支出，其中包括2,300 萬美元用於研發、1,200 萬美元用於SG&A、3,200 萬美元用於員工成本、800 萬美元用於租金和稅收、400 萬美元用於償還PGE 貸款，以及200 萬美元用於償付 PGE 貸款。2 月完成的融資帶來的 2,300 萬美元淨現金流入部分抵銷了 100 萬美元的不利外匯影響。

And a $21 million net cash inflow from the European Investment Bank loan from a $6 million of net cash received from the research tax credit refinancing, a $1 million cash outflow related to the grant, a refundable advances from BPI, $3 millions of financial investments' capital gain and interests, a $1 million reimbursement of social charges paid on stock options, and a $2 million net cash inflow from licenses and other cash receipts.

來自歐洲投資銀行貸款的2,100 萬美元淨現金流入來自研究稅收抵免再融資收到的600 萬美元淨現金，與贈款相關的100 萬美元現金流出，BPI 的可退還預付款，300 萬美元的金融投資資本利得和利息、100萬美元償還股票選擇權支付的社會費用、以及來自許可證和其他現金收入的200萬美元淨現金流入。

With cash and cash equivalents of $67.4 million as of September 30, 2023, and a $105 million from the AstraZeneca agreement. The company believes that we have sufficient resources to continue operating for at least 12 months following the consolidated financial statements' publication.

截至 2023 年 9 月 30 日，現金和現金等價物為 6,740 萬美元，以及來自阿斯特捷利康協議的 1.05 億美元。公司相信，我們有足夠的資源在合併財務報表發布後至少繼續營運 12 個月。

Additionally, the MOU contemplates that AstraZeneca will make a potential further equity investment in Cellectis of $140 million by subscribing for two newly created classes of convertible preferred shares of Cellectis.

此外，諒解備忘錄還考慮阿斯特捷利康將透過認購 Cellectis 兩類新創建的可轉換優先股，對 Cellectis 進行 1.4 億美元的進一步股權投資。

If confirmed the closing of the additional investment will remain subject to Cellectis shareholder approval with a two-thirds majority of the votes cast by voting shareholders and a clearance of such investments from the French Ministry of Economy according to the foreign direct investment, French regulations and other customary closing conditions.

如果得到確認，追加投資的完成仍需獲得 Cellectis 股東的批准，並獲得投票股東三分之二多數票的批准，並根據外國直接投資、法國法規和法國經濟部批准此類投資。其他慣例成交條件。

So the current with these additional $140 million in our anticipated borrowing of EUR15 million under the Tranche B of the EUR40 million finance contract with a European Investment Bank, the company believes that we would extend this cash runway into 2026.

因此，目前我們在與歐洲投資銀行簽訂的 4000 萬歐元融資合約的 B 部分中預期借入 1500 萬歐元，其中新增了 1.4 億美元，公司相信我們將把這條現金跑道延長到 2026 年。

The closing of the proposed Calyxt Merger was finalized on May 31, 2023. Consequently, Calyxt was de-consolidated and presented as discontinued operation in the financial statements only until May 31, 2023.

擬議的 Calyxt 合併於 2023 年 5 月 31 日完成。因此，Calyxt 被取消合併，並僅在 2023 年 5 月 31 日之前在財務報表中列為非持續經營業務。

The net loss attributable to shareholders of Cellectis was $58 million were $1.7 per share. For the nine months of 2023, of which $53(sic - press release, page 8, $53.2 million) million was attributed to Cellectis continuing operation compared to $79 million or $1.74 per share. For the nine months ended September 30, 2022, of which $73 million was attributed to Cellectis continuing operations.

Cellectis 股東應佔淨虧損 5,800 萬美元，每股虧損 1.7 美元。 2023 年的 9 個月中，其中 5300 萬美元（原文如此 - 新聞稿，第 8 頁，5320 萬美元）歸因於 Cellectis 的持續運營，而 7900 萬美元或每股 1.74 美元。截至 2022 年 9 月 30 日的九個月，其中 7,300 萬美元歸因於 Cellectis 的持續營運。

The $21 million decrease in net loss between the first nine months of 2023 and 2022 was primarily driven by a $14 million decrease from R & D expenses and a $4 million decrease of SG&A expenses, and also increased $4 million or the financial gain due to the de-consolidation of Caelyx compensated in part, but the decrease of fair value Cytovia's note receivable and decrease of $2 million(sic- press release, page 8 "$2.2 million) loss from discontinued operations attributable to the shareholders of Cellectis.

2023 年前 9 個月至 2022 年淨虧損減少 2,100 萬美元，主要是由於研發費用減少 1,400 萬美元，SG&A 費用減少 400 萬美元，此外，由於Caelyx 的取消合併部分彌補了這一損失，但Cytovia 的應收票據公允價值下降，並且因Cellectis 股東應佔的終止經營業務損失減少了200 萬美元（原文如此，新聞稿，第8 頁「220 萬美元）」。

These downward impacts on the net loss were partially offset by a decrease of $1 million (sic - press release, page 8, "$1.2 million) of revenues and other income.

這些對淨虧損的下降影響被收入和其他收入減少 100 萬美元（原文如此 - 新聞稿，第 8 頁，「120 萬美元」）所部分抵銷。

The adjusted net loss attributable to shareholders of Cellectis, which excludes non-cash stock based compensation expenses, was $57 million, were $1.05 per share in the first nine month period of 2023 compared to a loss of $72 million or $1.58 per share in the first nine months of 2022. 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 Raleigh.

不包括非現金股票補償費用的調整後歸屬於Cellectis 股東的淨虧損為5,700 萬美元，2023 年前9 個月為每股1.05 美元，而2023 年前9 個月的虧損為7,200 萬美元，即每股1.58 美元2022 年的九個月裡。我們將集中精力將現金用於開發我們的臨床候選藥物以及運營我們在巴黎和羅利的最先進的製造工廠。

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

此外，我們對維持高效率的企業基礎設施的關注也應該使一般管理費用的成長更加有限。

At this point, I'd like to hand it back to Andre for closing remarks.

現在，我想把它交還給安德烈做總結發言。

Thank you, Bing. Post out this call, I would like to reiterate how excited we are about a strategic collaboration with AstraZeneca and how much confident we are about the continued progress of our three ongoing clinical trials in[ hematological malignancies ] as well as our continued development of our pre-clinical program.

謝謝你，賓。在發出這次電話會議後，我想重申我們對與阿斯特捷利康的策略合作感到多麼興奮，以及我們對我們正在進行的三項[血液惡性腫瘤]臨床試驗的持續進展以及我們對預治療藥物的持續開發充滿信心。- 臨床計劃。

At Cellectis, we strongly believe that our product candidates, our technologies and our in-house manufacturing capabilities will lead us and our partners to a paradigm shift for patient with hard to treat cancer, positioning us at the forefront of this promising medical and scientific field. With that I would like to open the call for question and answers.

在Cellectis，我們堅信我們的候選產品、我們的技術和我們的內部製造能力將引領我們和我們的合作夥伴為難以治療的癌症患者進行範式轉變，使我們處於這個充滿希望的醫療和科學領域的最前沿。在此我想開始問答徵集活動。

Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. (Operator Instructions)

謝謝。女士們、先生們，我們現在將進行問答環節。 （操作員說明）

Kelly Shi with Jefferies.

施凱莉與傑弗里斯。

Hi, this is Dev prasad on for Kelly Shi. Thank you for taking our question and congratulations on the updates.

大家好，我是 Dev prasad，為 Kelly Shi 做主播。感謝您提出我們的問題並祝賀我們的更新。

I have one question on UCART20x22 you showed a great result, DL 1. So my question is, do you plan to increase the enrollment sites and and how many dose level do you anticipate to study before finalizing the RP2D?

我有一個關於 UCART20x22 的問題，您顯示了很好的結果，DL 1。所以我的問題是，您是否計劃增加註冊地點以及在最終確定 RP2D 之前您預計要研究多少劑量水平？

Dev thank you so much for this first question which will go to Mark

開發人員非常感謝您提出第一個問題，該問題將由馬克提出

Hi thanks for the question. And yes, we will -- we anticipate doing an escalation obviously, and the data from the subsequent escalation will obviously determine, where we stop and calling RP2D. So right now, it's right now it's to be determined with the clinical data.

您好，謝謝您的提問。是的，我們會——我們顯然預計會進行升級，而後續升級的數據顯然將決定我們在哪裡停止並調用 RP2D。所以現在需要根據臨床數據來確定。

Thank you.

謝謝。

Gena Wang, Barclays.

王吉娜，巴克萊銀行。

This is [Jan Keno]. So we have two questions on your clinical programs, one is that you previously guided UCART123 I believe it by end of 2023, May I ask like the timeline for now would it be a late breaker for ASH?

這是[揚·基諾]。因此，我們對您的臨床計劃有兩個問題，一是您之前指導了 UCART123，我相信會在 2023 年底之前完成，我可以問一下現在的時間表嗎？

And another question is the next step for UCART22 you mentioned about potential to advance to pivotal study without further dose escalation is that still the plan? Thank you.

另一個問題是 UCART22 的下一步，您提到有可能在不進一步增加劑量的情況下進入關鍵研究，這仍然是計劃嗎？謝謝。

Great. Thank you very much for both questions. That will be for Mark.

偉大的。非常感謝您提出的兩個問題。那是給馬克的。

So for UCART123, we began at ASH last year, we announced how we were or remodeling the treatment program to include the two dose regimen. And we are continuing on in that two dose regimen in dose escalation. So we anticipate that we will really be clinical data at some point next year.

因此，對於 UCART123，我們從去年的 ASH 開始，宣布了我們如何改變治療方案以包括兩種劑量方案。我們正在繼續劑量遞增的兩種劑量方案。因此，我們預計明年某個時候我們將真正獲得臨床數據。

And in terms of UCART22 study, I guess we in fact, we've pointed out in the abstract for ASH that we have dose escalated to 2.5 million cells per kilo with the [22P2] products. So we will see where that data bears this out and as we move ahead.

就 UCART22 研究而言，我想事實上我們已經在 ASH 的摘要中指出，我們使用 [22P2] 產品將劑量升級至每公斤 250 萬個細胞。因此，當我們繼續前進時，我們將看看這些數據在哪裡證實了這一點。

Gena, do you have any questions?

吉娜，你還有什麼問題嗎？

Thank you so much for taking our questions. Maybe one last follow up question on the AstraZeneca deal. Is there a time line that they have to select certain lead targets? And would you only give it as hold like early hold if they turn it down?

非常感謝您接受我們的提問。也許是關於阿斯特捷利康交易的最後一個後續問題。他們必須選擇某些領先目標是否有時間限制？如果他們拒絕的話，你只會像早期保留一樣保留它嗎？

Sorry, I'm not sure I understood the --. This is Edison Arthur. I'm not sure I understood the end of the question. But definitely so as part of the agreement Astrazeneca will have to choose up to 10 candidate products from a pool of 25. And then once the 10 products are selected, the remaining non-selective targets will come back to us.

抱歉，我不確定我是否理解了——。這是愛迪生·阿瑟。我不確定我是否理解了問題的結尾。但毫無疑問，作為協議的一部分，阿斯特捷利康必須從 25 種候選產品中選擇最多 10 種候選產品。一旦選擇了 10 種產品，剩下的非選擇性目標將返回給我們。

Okay, got it. Thank you.

好，知道了。謝謝。

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

I think this is Carly on for you guys. Thanks for taking our questions. I had two from us. First on your UCART22 and UCART20x22. Just wanted to clarify if we should expect data on additional patients at ASH to relative to the abstract? Or will the ASH data before focused on longer-term follow-up from the patients or just the patient included in the abstract?

我想這是卡莉為你們準備的。感謝您回答我們的問題。我們有兩個。首先在您的 UCART22 和 UCART20x22 上。只是想澄清一下，我們是否應該預期 ASH 的其他患者的數據與摘要相關？或者先前的 ASH 數據會關注患者的長期追蹤還是僅關注摘要中包含的患者？

And then the second question is on that potential additional $140 million equity investment from AstraZeneca. Just wondering if you can clarify if there is a specific trigger for that from AstraZeneca side and what's the potential timing might be? Thank you.

第二個問題是關於阿斯特捷利康可能追加的 1.4 億美元股權投資。只是想知道您是否可以澄清阿斯特捷利康方面是否有特定的觸發因素以及潛在的時機是什麼？謝謝。

Great. So I'll hand it over to Mark for the first business question, and I'll take the question on the AstraZeneca deal.

偉大的。因此，我將把第一個商業問題交給馬克，我將回答有關阿斯特捷利康交易的問題。

Thank you. Yes, for in terms of the two abstracts that we will be presenting, we will be presenting some follow up on the patient's described in the abstract.

謝謝。是的，因為就我們將要呈現的兩篇摘要而言，我們將呈現摘要中描述的患者的一些後續情況。

Yes, on the $40 million. So this is subject to a few closing conditions, including approval of our shareholder that are to certain majority of the votes cast and clearance for according to a foreign direct investment french regulation, and a couple of unless other customary closing conditions. We're working expeditiously to finalize these.

是的，4000萬美元。因此，這需要滿足一些成交條件，包括根據法國外國直接投資法規獲得我們股東的多數票批准和批准，以及一些除非其他慣常成交條件的條件。我們正在迅速完成這些工作。

Okay, got it. Thank you.

好，知道了。謝謝。

Hartaj Singh, Oppenheimer.

哈塔吉·辛格，奧本海默。

Great. Thank you, and thanks for the update. And I got two questions. One is you're starting to show some complete responses in BALLI-01 and NATHALI-01. I was wondering what would you view as sort of like a durability from a durability perspective? How many months of follow-up would you like to see? When you do when you could classify these as being very durable responses, especially on the CR side? And my second question is yes, specific to UCART123.

偉大的。謝謝你，也謝謝你的更新。我有兩個問題。一是你開始在 BALLI-01 和 NATHALI-01 中顯示一些完整的回應。我想知道從耐用性的角度來看，您認為什麼是耐用性？您希望看到多少個月的追蹤？當你這樣做時，你可以將這些歸類為非常持久的反應，尤其是在 CR 方面？我的第二個問題是肯定的，具體針對 UCART123。

Have you switched over to the commercial product there also? And if not, what's the timing on that? Thank you.+

您也轉向那裡的商業產品了嗎？如果沒有，具體時間是什麼時候？謝謝。+

Thanks for those questions. And Mark, over to you.

謝謝你提出這些問題。馬克，交給你了。

Thanks, Hartaj, for the questions. So I'll start with the UCART123 first and further UCART123 . We are still currently using the CDMO made product for UCART123 and that's where we are with that right now. In terms of your first question, yes, we are definitely seeing CRs, as you pointed out in the two studies.

謝謝哈塔吉提出的問題。因此，我將首先從 UCART123 開始，然後再從 UCART123 開始。我們目前仍在使用 CDMO 為 UCART123 製造的產品，這就是我們現在的情況。關於你的第一個問題，是的，正如你在兩項研究中指出的那樣，我們確實看到了 CR。

I think importantly, the stress for the UCART20x22 studies at the initial dose level, we did see two metabolic CRs is were in patients that failed prior CD19 CAR -T in addition to several other therapies. So I think in the setting of 19 failures on having two CRs, is great is great news at this dose level.

我認為重要的是，UCART20x22 研究在初始劑量水平的壓力，我們確實看到兩個代謝 CR 是在先前 CD19 CAR -T 以及其他幾種療法失敗的患者中。所以我認為，在 19 次失敗的情況下，兩次 CR 失敗，在這個劑量水平上是個好消息。

I think in terms of your question for durability, I think that remains to be seen given the the line of therapy that we're in and giving the extensive therapies that these patients have been relapse and refractory from I think at some point looking into three to six month range is not unreasonable. It's interesting to look for good duration of response in these patients.

我認為就你關於耐久性的問題而言，我認為考慮到我們正在接受的治療方案以及給予這些患者的廣泛治療，這些患者已經復發和難治，我認為這還有待觀察，我認為在某些時候研究了三個至六個月的範圍並非不合理。尋找這些患者的良好反應持續時間是很有趣的。

Great. Thank you, Mark. Thanks for all the questions.

偉大的。謝謝你，馬克。感謝您提出所有問題。

Jack Allen, Baird

傑克艾倫、貝爾德

Thanks for taking the questions and congratulations on the team on the progress. My question is also as it relates to the ASH abstracts really impressive results UCART20x22 program. As a first dose level here, as I was wondering, and I see if the team had any comments about the need to escalate dose are you satisfied with the but the early results you are seeing here? Love to hear about that.

感謝您提出問題並祝賀團隊的進展。我的問題也是因為它涉及 ASH 摘要真正令人印象深刻的結果 UCART20x22 程序。正如我想知道的那樣，作為這裡的第一個劑量水平，我會看看團隊是否對增加劑量的必要性有任何評論，您對您在這裡看到的早期結果感到滿意嗎？很高興聽到這個。

Yeah Jack, thanks for the question. And yes, I'm as you point out, three out of three responders at the initial dose level. And as also you can see the safety quite good at this dose level as well. And I think given given both of those facts, we will be we will in fact, be escalating those study just, you know, to see where we can get at it, the next higher dose level. So stay tuned for that.

是的，傑克，謝謝你的提問。是的，正如您所指出的，三分之三的人在初始劑量水平下有反應。您也可以看到，在這個劑量水平下，安全性也相當好。我認為考慮到這兩個事實，我們實際上會升級這些研究，看看我們能在哪裡達到下一個更高的劑量水平。所以請繼續關注。

And then just one brief follow-up on as it relates to longer follow-up on these patients on, can you provide some context around when the data was taken for ASH and what you expect to present at the conference? And then just to clarify on, we should be primarily focused on additional data from the first three patients rather than a second dose cohort as well.

然後只是一個簡短的隨訪，因為它涉及對這些患者的長期隨訪，您能否提供一些有關 ASH 數據採集時間的背景資訊以及您希望在會議上展示的內容？然後澄清一下，我們應該主要關注前三名患者的額外數據，而不是第二個劑量組的數據。

Yes. So we'll we'll be focusing on the first three patients for the poster presentation.

是的。因此，我們將重點放在海報展示的前三名患者。

Any thoughts on additional kind of follow up there or what kind of thought we could expect from those three patients at the conference?

對於額外的追蹤有什麼想法，或者我們可以期望會議上的這三名患者有什麼樣的想法？

So well, we'll give some further follow up that we have on them. So please come by and visit us at the poster.

那麼，我們將對它們進行進一步的跟進。所以請您來參觀我們的海報。

Great. Thanks so much.

偉大的。非常感謝。

Salveen Richter, Goldman Sachs

薩爾文·里克特，高盛

Hi, this is Whitney on for Salveen. Thanks, much for taking your question. Could you just remind us of the strategy for UCART20x22 in terms of the targeted patient population given positive data at ASH?

大家好，我是薩爾文的惠特尼。非常感謝您提出問題。您能否提醒我們 UCART20x22 在 ASH 上獲得積極數據的目標患者群體方面的策略？

Thank you very much for the question that would be for Mark.

非常感謝您向馬克提出的問題。

Hi. Yes, thank you for the question. So you know, we are -- is in third-line or greater that we're using this, and this is prior CD19 failures are also included in this study. So that's where we're continuing.

你好。是的，謝謝你的提問。所以你知道，我們正在使用該藥物，處於第三線或更高級別，之前的 CD19 失敗也包含在本研究中。這就是我們要繼續的地方。

Silvan Tuerkcan, JMP Securities

Silvan Tuerkcan，JMP 證券

Good morning and congrats and thanks for taking my question. My first question is now that you have human data with UCART22 with product 1 and product 2. Do we do we know what why products to so much more potent? You have any metrics reflects a two times or more (technical difficulty)

早安，恭喜並感謝您提出我的問題。我的第一個問題是，現在您擁有 UCART22 的人類資料以及產品 1 和產品 2。我們是否知道為什麼產品如此有效？你有任何指標反映了兩倍或更多（技術難度）

And then a second question is, are there any more near term milestones associated with our schemes, anti CD-70, the or [anti cloudin 18] programmes? You could be getting. Thank you so much.

第二個問題是，是否還有與我們的計畫、抗 CD-70 或 [抗雲 18] 計畫相關的近期里程碑？你可能會得到。太感謝了。

Great. Thank you very much for both questions. I'll hand it over to Andre for the first one.

偉大的。非常感謝您提出的兩個問題。我會把第一個任務交給安德烈。

Yes, hi, nice events that and thank you very much for the nice question because I think that the manufacturing that tottaly makes a huge difference.

是的，嗨，很好的活動，非常感謝你提出這個好問題，因為我認為製造業完全產生了巨大的影響。

And as Mark described this presentation, there is process one the process that was used at the CMO initially, and the one we've implemented after internally this process two. So there's few that have changed. We know exactly why. One day someone asked me a question in about how we do it, how we can do cells that have so much potency.

正如 Mark 在本次演示中所描述的，流程一是 CMO 最初使用的流程，也是我們在流程二之後在內部實施的流程。所以幾乎沒有什麼改變。我們確切地知道原因。有一天，有人問我一個問題，關於我們如何做到這一點，我們如何製造出具有如此強大效力的細胞。

And let me tell I'm going to share this quick review here online.

讓我告訴你，我將在網上分享這篇快速評論。

So I see all the faces around me. Andre don't do this I'm going to do it. Well, we've done close to 10,000 batches internally in the process development. We've done and crushed and crushed and crushed cells and tweaked every parameter and there are hundreds of parameter. This is called experience.

所以我看到了周圍所有的臉。安德烈不這樣做，我要這樣做。嗯，我們在流程開發中已經內部完成了近 10,000 個批次。我們已經完成了粉碎細胞並調整了每個參數，有數百個參數。這就是所謂的經驗。

We are the ones that have invented the concept of allogenic CAR-T. I can tell you that like the post that didn't came out like this slide from from the ground, it took a long time before we go to the point where we are. And today, I think that will probably, the best on the planet to do allogenic CAR-T, as Mark said, come at our poster session at at ASH, watch the expansion of the cells, even a super low doses.

我們是同種異體 CAR-T 概念的發明者。我可以告訴你，就像沒有像這張幻燈片那樣從地面上出來的帖子一樣，我們花了很長時間才達到現在的水平。今天，我認為，正如 Mark 所說，地球上最好的同種異體 CAR-T 技術可能會出現在 ASH 的海報會議上，觀察細胞的擴增，即使是超低劑量。

You will see what it means that such type of experience and experience cannot be invented in a day. It can be transmitted, but we don't know transmit the 10 years of crushing batch after batch of small, midsize to large size, batch in GMP conditions, et cetera. Up to the time we have tweaked all parameter to perfection.

你會明白這意味著什麼，這種體驗和經驗不可能一天發明。它可以傳播，但我們不知道傳播10年一批又一批的小型、中型到大型、GMP條件下的批次破碎等等。到目前為止，我們已經將所有參數調整到完美。

That's the answer. And for the Allogene?

這就是答案。對於同種異體呢？

Thanks, André. And on the Allogene questions. So we definitely have a significant vested interest Allogene success, just remembering upto to $410 million in development and sales milestones for CD- 19 through our agreement with the survey and up to $2.8 billion in development and sales milestones.

謝謝，安德烈。還有關於同種異體的問題。因此，我們肯定對 Allogene 的成功有著重大的既得利益，只要記住透過我們與調查達成的協議，CD-19 的開發和銷售里程碑高達 4.1 億美元，開發和銷售里程碑高達 28 億美元。

We haven't disclosed the granularity of the milestones, but we'll invest in if you communicate that in when Allogene hit those milestones and we get at the amounts in our back.

我們尚未透露里程碑的具體細節，但如果您在 Allogene 達到這些里程碑時傳達這一訊息，我們將進行投資，並且我們將獲得後面的金額。

Great.Thanks for revealing the secret sauce.

太棒了。感謝您透露秘密。

Yanan Zhu , Wells Fargo

朱亞男，富國銀行

This is Kwan Kim for Yunnan. So my question is on the new CAR-T 22. So can you give us more detail about the grade by AE now was revealed in the abstract and how that may affect the further study contact? Thank you.

這是雲南的 Kwan Kim。所以我的問題是關於新的 CAR-T 22。那麼您能否給我們更多有關摘要中顯示的 AE 等級的詳細信息，以及這可能如何影響進一步的研究聯繫？謝謝。

Thank you for the question, and this will be for Mark.+

謝謝你的提問，這是給馬克的。+

So as you know, as we rebuild in the abstract, this grade five events happened after long after several couple of weeks after the day 28 assessment in this patient who had a morphologic leukemia-free state. So as bacterial infection that the investigator related, related to everything, which is why it's there. So it's really not affecting anything as we move move ahead.

如您所知，正如我們在摘要中重建的那樣，這個 5 級事件是在這位形態學上無白血病狀態的患者在第 28 天評估後幾週後發生的。因此，作為調查員所涉及的細菌感染，與一切都相關，這就是它存在的原因。因此，當我們繼續前進時，它實際上不會影響任何事情。

Got it. Is there a way to quantify how much of that was contributed by the UCART22 itself or the [ MUC1] Thank you.

知道了。有沒有辦法量化 UCART22 本身或 [MUC1] 貢獻了多少，謝謝。

Yes. So there's some, , has will show on the poster. There's a level of expansion that was seen with the cells by flow [cytometry]. At the time point of this event happen, we don't believe there were any UCART22 cells record remaining. So we think that the likelihood it was less related to UCART22.

是的。所以有一些， ， 將會出現在海報上。透過流式[細胞儀]觀察到細胞有一定程度的擴增。在這次事件發生時，我們認為沒有任何 UCART22 細胞記錄剩餘。所以我們認為它與 UCART22 的相關性較小。

This was a patient who was again, as outlined in the abstract, was super heavily pretreated, they failed alo transplant, they failed prior octalagus CAR-T. They failed multi-agent chemo in and they also failed blinatumomab or inotuzumab and venetoclax.

正如摘要中所概述的，這位患者再次接受了超嚴格的預處理，他們失敗了 alo 移植，他們之前的八面體 CAR-T 失敗了。他們的多藥化療失敗了，blinatumomab 或inotuzumab 和venetoclax 也失敗了。

So the cumulative dose in the prior chemo that they made and going into this study very high both cellular explained some of the issues that are developed.

因此，他們先前進行的化療和進入本研究的累積劑量非常高，這兩種細胞解釋了所出現的一些問題。

That's super helpful. Thank you so much.

這非常有幫助。太感謝了。

Thank you. As there are no further questions, I would now hand the conference over to Andre Choulika, CEO for closing comments.

謝謝。由於沒有其他問題，我現在將會議交給執行長安德烈·喬利卡 (Andre Choulika) 進行總結評論。

Well, first of all, I would like to thank the team for helping in doing the call here. It's been a pleasure to prepare this together, and I would like very warmly thank all the analysts that have been following the covenants supporting in watching what we're doing is very valuable.

嗯，首先，我要感謝團隊幫忙進行這通電話。很高興一起準備這個，我要非常熱烈地感謝所有一直遵循這些契約並支持我們所做的事情的分析師，這些都是非常有價值的。

And I would like to make a special word of so to our long-term shareholders that has been continuously supporting the company over the past years. And I hope that to the company is going to have like a very strong end of '23 and '24 and '25 and '26.

我想特別向我們的長期股東表示感謝，他們在過去幾年中一直持續支持公司。我希望公司能夠在 23 年、24 年、25 年和 26 年有一個非常強勁的結局。

So we'll come up very soon for an update on the progress. Thank you very much.

因此，我們將很快發布最新進展。非常感謝。

Thank you.+ The conference of Cellectis has now concluded. Thank you for your participation. You may now disconnect your lines.

謝謝。+ Cellectis 會議現已結束。感謝您的參與。現在您可以斷開線路。