Gracell Biotechnologies Inc (GRCL) 2023 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to Gracell Biotechnologies Third Quarter 2023 Conference Call. (Operator Instructions) I will now turn the conference call over to Dr. Kevin Xie, Chief Financial Officer. Please go ahead.

女士們，先生們，感謝各位的支持。歡迎參加亙喜生物科技2023年第三季電話會議。 （接線生指示）現在，我將電話會議交給財務長謝志文博士。請開始。

Good morning, and welcome to Gracell Third Quarter 2023 Corporate Update Conference Call and Webcast. With me today are Gracell founder and Chief Executive Officer, Dr. Wei Cao; and our Chief Medical Officer, Dr. Wendy Li. We're excited to discuss the advancement of the trials underway with our CAR-T candidate on today's call. We're looking forward to share with you our recent business developments and upcoming objectives as we have 6 weeks remaining in 2023 and are looking forward to 2024. As a reminder, we'll conduct a question-and-answer session following our formal remarks.

早安，歡迎參加亙喜生物 2023 年第三季公司業績更新電話會議及網路直播。今天與我一同出席的有亙喜生物創辦人兼執行長曹煒博士和首席醫學官李文迪博士。我們很高興在今天的電話會議上討論我們 CAR-T 候選藥物正在進行的臨床試驗進展。 2023 年還剩 6 週，我們期待與大家分享我們近期的業務發展和未來目標，展望 2024 年。在此提醒，我們將在正式發言後進行問答環節。

This morning, Gracell issued a press release announcing unaudited financial results for the third quarter ended September 30, 2023. We encourage everyone to read this press release, and I would like to remind you that this call is being recorded for replay. Please note that for certain information discussed on the call today, including financial data, clinical data, future plans of our program, resource management will be making forward-looking statements. Actual results could differ materially from those stated or implied by those forward-looking statements as a result of various important factors, and please refer to the Risk Factors section of our latest 20-F filings with SEC for a full disclosure of these risks and factors.

今天上午，亙喜生物發布了一份新聞稿，宣布了截至2023年9月30日的第三季未經審計財務表現。我們鼓勵大家閱讀這份新聞稿，並在此提醒大家，本次電話會議將會被錄音以便重播。請注意，對於今天電話會議上討論的某些信息，包括財務數據、臨床數據、專案的未來計劃，資源管理層將做出前瞻性陳述。由於各種重要因素，實際結果可能與這些前瞻性聲明中明示或暗示的結果有重大差異，請參閱我們向美國證券交易委員會 (SEC) 提交的最新20-F文件中的「風險因素」部分，以全面了解這些風險和因素。

This conference call contains time-sensitive information that is accurate only as of the date of the live forecast, November 13, 2023. Gracell undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by (inaudible) securities laws. I will now turn the call over to Gracell CEO, Dr. Wei Cao. William?

本次電話會議包含截至即時預測日期（2023年11月13日）的時效性資訊。亙喜生物不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後的事件或情況的義務，除非（聽不清楚）證券法另有規定。現在我將電話會議交給亙喜生物執行長曹煒博士。威廉？

Thank you, Kevin. And again, welcome, everyone, to today's call. I will begin with the key pipeline and corporate updates. I will then turn the call over to our CMO, Dr. Wendy Li, to provide insights into GC012F clinical data that were recently presented at the 20th International Myeloma Society, IMS Annual Meeting. Next, our CFO, Dr. Yili Xie, will discuss our third quarter 2023 financial results. After our prepared remarks, we will open the call to questions.

謝謝凱文！再次歡迎大家參加今天的電話會議。首先，我將介紹公司的主要研發管線和最新動態。然後，我將把電話會議交給我們的行銷長李文迪博士，她將詳細介紹最近在第20屆國際骨髓瘤學會IMS年會上公佈的GC012F臨床數據。接下來，我們的財務長謝一力博士將討論我們2023年第三季的財務表現。在準備好的發言稿之後，我們將開始提問環節。

The past few months have been exciting, both for Gracell and the CAR-T field at large. At Gracell, we have achieved several important milestones, including the initiation of patient dosing in our first company-sponsored the U.S. trial, the presentation of the latest update of FasTCAR-T GC012F at the recent IMS meeting and upcoming American Society of Hematology Annual Meeting. The advancement of the investigator initiative clinical study in systemic lupus, erythematosus, SLE and also release of preclinical data from our solid tumor program at a society of immunotherapy of cancer, SITC Annual Meeting.

過去幾個月，亙喜生物和整個 CAR-T 領域都很興奮。亙喜生物取得了多個重要里程碑，包括首次由公司贊助的美國臨床試驗啟動患者給藥；在近期的 IMS 會議和即將召開的美國血液學會 (ASHE) 年會上展示了 FasTCAR-T GC012F 的最新進展；針對系統性紅斑狼瘡 (SLE) 的研究者主動提出臨床研究學會在臨床研究者身上取得了免疫治療計畫

This period marked a crucial juncture for the CAR-T field. Some of the most significant hurdles based by CAR-T in the treatment of blood cancers are being addressed by innovative next-generation CAR-T candidates. Aspirations such as rapid manufacturing, achieving a cleaner safety profile and enabling deeper, more durable responses were shared by all company researchers and were also personal motivators for myself that led to the funding of Gracell.

這段時期是CAR-T領域的關鍵時刻。 CAR-T技術在血癌治療中面臨的一些最重大障礙，正被創新的下一代CAR-T候選藥物所攻克。所有公司研究人員都懷抱著共同的願望，例如快速生產、實現更清潔的安全性以及實現更深層次、更持久的療效，而這些願望也促使我投資亙喜生物。

It was a journey with a vision to push the boundaries of what's possible in cancer treatment. The progress we have made is a testament to the entire Gracell team's relentless pursuit of innovation. We are also finding ourselves at the forefront of our pivotal era in medical science, where the application of CAR-T therapy is expanding beyond hematological cancers, (inaudible) need in other immune diseases and solid tumors are massive. At Gracell, our approach is anchored in rigorous scientific research and commitment to innovation. I am pleased to see strides we have made in these disease areas, reflecting our dedication to addressing areas of high unmet need with cutting-edge solutions.

這是一段充滿願景的旅程，旨在突破癌症治療的極限。我們所取得的進展印證了亙喜生物團隊對創新的不懈追求。我們也正處於醫學科學關鍵時代的前沿，CAR-T療法的應用範圍正在拓展，不再局限於血液系統癌症，（聽不清楚）其他免疫疾病和實體腫瘤的需求也十分巨大。在亙喜生物，我們的方法以嚴謹的科學研究和對創新的承諾為基礎。我很高興看到我們在這些疾病領域的進展，這反映了我們致力於用尖端解決方案解決尚未滿足的重大需求領域的決心。

Today, we will share some initial findings in our translational research on CC012F for the treatment of SLE. I look forward to sharing our ongoing progress and remain confident that our journey will lead to meaningful advancement in the field. Now I hope to provide a more detailed overview of what we have achieved in the third quarter. In September, we announced dosing our first patient in the U.S. Phase Ib/II investigation on new drug IND study, evaluating our lead candidate, BCMA-CD19 dual targeting FasTCAR GC012F in the treatment of relapsed refractory multiple myeloma, RRMM.

今天，我們將分享CC012F治療SLE的轉化研究的一些初步成果。我期待分享我們正在進行的進展，並堅信我們的研究將為該領域帶來有意義的進步。現在，我希望更詳細地概述我們在第三季所取得的成果。 9月，我們宣佈在美國新藥IND Ib/II期臨床試驗中完成首例患者給藥，該試驗評估了我們的主要候選藥物BCMA-CD19雙靶向FasTCAR GC012F在治療復發難治性多發性骨髓瘤（RRMM）中的療效。

One clinical site is currently recruiting patients, and we look forward to activating a handful additional sites in the U.S. in the coming months. As a reminder, the Phase Ib portion is designed to evaluate safety and tolerability of GC012F as well as determine the recommended Phase II dose. We anticipate enrolling approximately 12 patients across 2 dose levels in the Phase Ib portion. We estimate that it will likely take approximately 9 to 10 months to complete patient enrollment. In China, we expect to commence patient enrollment this quarter in the Phase I/II IND study in (inaudible).

目前，一個臨床研究中心正在招募患者，我們期待在未來幾個月內在美國啟動更多研究中心。 Ib期臨床試驗旨在評估GC012F的安全性和耐受性，並確定II期臨床試驗的建議劑量。我們預計在Ib期臨床試驗中，將招募約12名涵蓋兩個劑量等級的患者。我們估計完成患者入組大約需要9到10個月。在中國，我們預計本季開始在中國（聽不清楚）進行的I/II期IND研究的患者入組。

The guidelines for clinical research on thematic cells trial, newly elected in August has impacted our timeline, but we are happy to report that we have now received all the required approvals and are ready to launch the study in China. In next September, at the IMS Annual Meeting, the updated clinical data was presented from the ongoing Phase I IIT evaluating GC012F as a frontline treatment for patients with transplant eligible, high-risk, newly diagnosed multiple myeloma, NDMM. In this 19 patient data set with a median of 15 months, 100% of patients achieved minimal residual disease, negative tangent complete response, MRD negative SCR. Dr. Wendy Li will elaborate on the key findings in a few minutes.

8月新出台的主題細胞臨床試驗臨床研究指南影響了我們的時間表，但我們很高興地宣布，我們現在已獲得所有必要的批准，並準備在中國啟動這項研究。明年9月，在IMS年會上，我們將公佈正在進行的I期臨床試驗的最新臨床數據，該試驗旨在評估GC012F作為適合移植的高風險新診斷多發性骨髓瘤（NDMM）患者的一線治療。在這組19位患者的數據中，中位存活期為15個月，100%的患者達到了微小殘留病灶（MRD）、負向正切完全緩解（NCR）和MRD負向SCR。 Wendy Li博士將在幾分鐘內詳細闡述關鍵發現。

Longer-term fall-off data from this study, including additional patients will be presented at the 65th ASH Annual Meeting in December. We are continuing to see compelling efficacy data and safety profile and look forward to sharing more details in San Diego next month. To this date, we have reported clinical data of GC012F on 60 oncology patients in 3 IITs, including 51 patients with multiple myeloma and 9 with diffuse large B-cell lymphoma. The consistent findings provide good evidence supporting our strong scientific rationale in leveraging the power of dual targeting and validating the superior qualities of FasTCAR-T cells.

這項研究的長期療效數據（包括更多患者）將於12月的第65屆ASH年會上公佈。我們持續關注著令人信服的療效數據和安全性，並期待下個月在聖地牙哥分享更多細節。迄今為止，我們已報告了GC012F在3個免疫治療（IIT）的60名腫瘤患者中的臨床數據，其中包括51名多發性骨髓瘤患者和9名瀰漫大B細胞淋巴瘤患者。這些一致的研究結果為我們利用雙靶向優勢並驗證FasTCAR-T細胞卓越特性的科學原理提供了有力的證據。

Also, the very favorable safety profile demonstrated in these studies, including no neurotoxicity observed in any of the 60 patients could potentially provide a critical differentiation in early line settings and additional indications. We are very encouraged by the profile of GC012F and have high confidence that this therapy could bring profound benefits to the patients worldwide. In the second quarter of this year, we were thrilled to launch a new IIT evaluating the 19 (inaudible) targeting GC012F in refractory SRE or R-SLE.

此外，這些研究展現出非常良好的安全性，包括在60例患者中均未觀察到任何神經毒性，這可能為早期治療及其他適應症的鑑別診斷提供關鍵依據。 GC012F 的優異表現令我們備受鼓舞，並堅信該療法將為全球患者帶來深遠的益處。今年第二季度，我們非常高興地推出了一項新的 IIT，該研究評估了19例（聽不清楚）針對 GC012F 治療難治性 SRE 或 R-SLE 的療效。

This new direction is inspired by the groundbreaking clinical discovery shared by Professor George Tsokos. We see immense opportunity here and believe 12F is ideally positioned as a potential treatment for many autoimmune conditions, including SRE, combining its safety track record, CD19 BCMA dual targeting capability and faster and consistent product delivery. In the field of automate disease treatment, safety stands as a critical factor for defining success. As oncologists learn ways to better manage the adverse events, the safety of CAR-T has become less of concern in cancer applications. However, we believe the focus on safety will be renewed when the industry seeks to potentially adopt CAR-T as a treatment for other autoimmune conditions.

這個新方向的靈感源自於喬治·索科斯教授分享的突破性臨床發現。我們看到了巨大的機遇，並相信12F憑藉其安全記錄、CD19 BCMA雙靶向能力以及更快、更穩定的產品遞送，將成為包括SRE在內的多種自體免疫疾病的理想治療方案。在自動化疾病治療領域，安全性是決定成功的關鍵因素。隨著腫瘤學家不斷學習更好地管理不良事件的方法，CAR-T在癌症治療中的安全性不再那麼令人擔憂。然而，我們相信，當業界尋求將CAR-T用於治療其他自體免疫疾病時，對安全性的關注將再次被重視。

Any successful therapy must demonstrate exceptional tolerability and safety profile. So far, TC012F has been used to treat 60 cancer patients, including those who are frail and fastening advanced cancer. We have observed a consistent safety profile characterized by mostly low-grade cytokine release syndrome, CRS, and notably, no incidences of neurotoxicity today. It is important to point out these encouraging results have been derived from the same compound currently being investigated in the IIT underway for SLE.

任何成功的療法都必須展現出卓越的耐受性和安全性。迄今為止，TC012F 已用於治療 60 名癌症患者，其中包括體弱且病情迅速惡化的晚期癌症患者。我們觀察到了一致的安全性，其特徵主要是低度細胞激素釋放症候群 (CRS)，值得注意的是，目前沒有神經毒性。值得一提的是，這些令人鼓舞的結果與目前正在進行的系統性紅斑狼瘡 (SLE) 免疫療法 (IIT) 中研究的同一種化合物相同。

This consistent track record of safety gives us confidence as we expand our studies to a new field where the standards for safety are exceptionally high. On the efficacy side, the promise of CAR-T (inaudible) where other auto-reactive cells are eliminated, and newly generated cells are expected to be healthy. For autoimmune diseases such as SLE, some were hoping to complete depletion of B cells could reset immune system. Based on this theory, CD19 is considered a valid target for CAR-T as it is expressed throughout the early and mature stage of B-cell.

這種持續的安全記錄讓我們充滿信心，因為我們可以將研究擴展到安全標準極高的全新領域。在療效方面，CAR-T療法（聽不清楚）的前景是，其他自身反應性細胞被清除，而新生細胞預計是健康的。對於系統性紅斑狼瘡（SLE）等自體免疫疾病，有些人希望透過徹底清除B細胞來重置免疫系統。基於這個理論，CD19被認為是CAR-T療法的有效靶點，因為它在B細胞的早期和成熟階段都有表達。

However, we think it's important to remember the SLE is a disease in which auto antibodies attack a patient's own tissues. So in addition to resetting B cells, our view is that an effective therapy should also address the disease-causing autoantibody-secreting cells or ASC. ASC populations could be CD19 plus or CD19 negative and are BCMA positive. So the use of CD19 single target in CAR-T therapy alone may not be sufficient to eliminate all auto antibody-producing cells in all patients. Therefore, we feel there is a strong scientific rationale to support targeting both BCMA and CD19, which aligns with GC012F design in order to provide a more effective and long-lasting therapeutic approach for refractory SRE.

然而，我們認為重要的是要記住，SLE 是一種自體抗體攻擊患者自身組織的疾病。因此，除了重置 B 細胞之外，我們認為有效的治療方法還應針對致病的自身抗體分泌細胞或 ASC。 ASC 群體可能是 CD19 陽性或 CD19 陰性，但 BCMA 陽性。因此，僅在 CAR-T 療法中使用 CD19 單標靶可能不足以清除所有患者體內所有產生自體抗體的細胞。因此，我們認為有強有力的科學依據支持同時針對 BCMA 和 CD19，這與 GC012F 的設計一致，旨在為難治性 SRE 提供更有效、更持久的治療方法。

In recent months, we have been working on preclinical and translational studies to support this rationale. Today, we are delighted to share some preliminary findings. First, we analyzed the samples from 4 initial patients treated with GC012F at onetime 10-5th cells per kilo dose. And after the 3 months follow-up, we can see B-cells have been restored to naive phenotype in these 4 patients. This provides a very encouraging early evidence that GC012F is inducing an immune reset.

近幾個月來，我們一直在進行臨床前和轉化研究來支持​​這個理論。今天，我們很高興分享一些初步發現。首先，我們分析了4位接受GC012F治療的患者的樣本，這些患者的單次劑量為每公斤10-5個細胞。經過3個月的隨訪，我們發現這4位患者的B細胞已恢復到幼稚表型。這提供了非常令人鼓舞的早期證據，顯示GC012F正在誘導免疫重置。

Secondly, we run studies with bone marrow samples collected from our SLE IIT patients and demonstrate that the CD19 BCMA dual-targeting CAR-T showed a more efficient elimination of ASC compared to CD19 single-targeting CAR-T. Taken together, we believe that our CD19 BCMA CAR-T addresses both B-cell and ASC and is designed to achieve a deeper and a wider elimination of disease-causing B-cells as well as plasma cell. You can find the details of these findings in our latest corporate presentation deck, and we look forward to sharing more at upcoming cell therapy for autoimmune summit later this month.

其次，我們利用從SLE IIT患者採集的骨髓樣本進行研究，證明CD19 BCMA雙標靶CAR-T療法比CD19單標靶CAR-T療法更有效清除ASC。綜上所述，我們認為我們的CD19 BCMA CAR-T療法能夠同時作用於B細胞和ASC，旨在更深層、更廣泛地清除致病B細胞以及漿細胞。您可以在我們最新的公司演示文稿中找到這些研究成果的詳細信息，我們期待在本月晚些時候即將舉行的自身免疫細胞療法峰會上分享更多信息。

Lastly, on the manufacturer side, we believe that GC012F is positioned favorably with overnight manufacturing and enhanced sales fitness combined with our team's significant experience accumulated over the years. Although SLE is a chronic disease, FasTCAR-T delivery is still highly meaningful for better clinical outcomes to ensure optimal CAR-T expansion in the patient body, patients typically need to stop SLE treatment before (inaudible) and also during the weight for CAR-T production, except for the use of low-dose steroids. Fast and consistent delivery of CAR-T therapy would help to shorten this period of suboptimal disease control and greatly reduce the risk of disease flare-up and additional organ damage during the wait.

最後，在製造商方面，我們認為GC012F憑藉其快速生產和更強的銷售適應性，以及我們團隊多年累積的豐富經驗，在市場中佔據有利地位。儘管SLE是一種慢性疾病，但FasTCAR-T遞送對於獲得更好的臨床療效仍然至關重要。為了確保CAR-T在患者體內達到最佳擴增，患者通常需要在CAR-T擴增前（聽不清楚）以及擴增期間停止SLE治療，除非使用低劑量類固醇。快速且持續的CAR-T療法遞送將有助於縮短疾病控制不佳的時期，並大大降低等待期間疾病復發和其他器官損害的風險。

In short, we believe 12F is a highly differentiated candidate backed by outstanding safety record, novel and a strong scientific rationale and FastCAR-T technology as well as supported by our team's extensive experience in manufacturing and optimizing the process. We eagerly anticipate advancing the clinical development of in-autoimmune disease. Currently, the IIT evaluating GC012F in SRE continues to enroll patients. More than a handful of patients have been treated, and the goal is for patient enrollment to progress into double-digit range. We expect to release the first public readout from this ongoing IIT in the first half of 2024.

簡而言之，我們相信12F是一款高度差異化的候選藥物，其安全性記錄卓越，科學原理新穎且嚴謹，並採用FastCAR-T技術，同時我們團隊在生產和工藝優化方面擁有豐富的經驗。我們熱切期待推進自體免疫疾病的臨床開發。目前，評估GC012F治療SRE的IIT仍在持續招募患者。目前已有多名患者接受了治療，我們的目標是使患者招募人數達到兩位數。我們預計將於2024年上半年發布該IIT的首份公開數據。

We are currently on track to submit IND filings in the U.S. and China in 2023 for the planned Phase I clinical trial. The U.S. submission will be the second IND for GC012F to be reviewed by the U.S. FDA and will be an important milestone as we continue to advance our efforts to provide innovative and effective treatment options to patients with auto immune disease. Beyond FasTCAR platform, we are also continuing to advance our SMART CART technology for the treatment of solid tumors. At the 60th Annual Meeting in early November, we presented the preclinical data evaluating SMART CART T cells in solid tumor models.

我們目前正按計畫於2023年在美國和中國提交IND申請，以進行計畫中的I期臨床試驗。這次提交的美國申請將是GC012F第二次獲得美國FDA審查的IND申請，這將是我們繼續努力為自體免疫疾病患者提供創新有效的治療方案的重要里程碑。除了FasTCAR平台外，我們也持續推進SMART CART技術，用於治療實體腫瘤。在11月初舉行的第60屆年會上，我們展示了評估SMART CART T細胞在實體腫瘤模型中的臨床前數據。

SMART stands For Suppressive Molecule Activated and Rejuvenated T cells. And our novel SMART CART T technology includes a proprietary switch receptor targeting the suppressive tumor marker environment, in which the inhibitory (inaudible) beta signal is blocked and converted into a pro T-cell signal in CAR-T cells. Our studies have shown that SMART CART T cells are younger and more resistant to TGF beta-mediated apoptosis and exhaustion.

SMART 代表抑制性分子活化並再生 T 細胞。我們創新的 SMART CART T 技術包含一個專有的開關受體，該受體靶向抑制性腫瘤標記環境，在這種環境下，抑制性（聽不見的）β 信號被阻斷，並在 CAR-T 細胞中轉化為促 T 細胞信號。我們的研究表明，SMART CART T 細胞更年輕，對 TGFβ 介導的細胞凋亡和衰竭具有更強的抵抗力。

Upon repeated challenges of tumor cells, SMART CART T cells show more potent and durable tumor-specific lysis than the conventional CAR-T, both in vitro and in vivo in the presence of TGF-beta, especially in most models, SMART CART-T exhibit better killing activities in tumor re-challenge studies and high tumor burden studies compared with conventional CAR-T. Earlier in the fourth quarter, we initiated an IIT in China to evaluate our SMART CART-T candidates, GC506 in patients with Claudin 18.2 positive solid tumors. We decided to further streamline our pipeline during the fourth quarter by continuing our focus in devoting our resources on programs that have been potential to be the best in class and address large unmet needs.

在反覆刺激腫瘤細胞後，SMART CART T 細胞表現出比傳統 CAR-T 更有效、更持久的腫瘤特異性裂解作用，無論是在體外還是在 TGF-β 存在的情況下，尤其是在大多數模型中，SMART CART-T 在腫瘤再刺激研究和高腫瘤負荷研究中均表現出比傳統 CAR-T 更好的殺傷活性。第四季初，我們在中國啟動了 IIT，以評估我們的 SMART CART-T 候選藥物 GC506 對 Claudin 18.2 陽性實體瘤患者的療效。我們決定在第四季進一步精簡我們的產品線，繼續將資源投入那些有望成為同類最佳並能滿足大量未滿足需求的項目上。

We suspended China Phase II trial evaluating GC007G for the treatment of B-cell acute lymphoblastic leukemia or BALL, considering the limited commercial opportunity for this niche candidate. As a reminder, we have seen compelling data in the Phase I study with GC007G, including 100% MRD-negative CR/CRI among 9BLL patients.

鑑於GC007G治療B細胞急性淋巴性白血病（BALL）的商業機會有限，我們暫停了在中國進行的II期臨床試驗。需要提醒的是，我們在GC007G的I期研究中獲得了令人信服的數據，其中包括9例BLL患者中100%獲得MRD陰性的完全緩解/緩解抑制（CR/CRI）。

GC007G is HLA-matched donor-derived allogeneic CAR-T and does not leverage our FasTCAR and TruUCAR-T technology platform or SMART CAR-T module. The updated pipeline chart will be found in the corporate presentation posted to Gracell's IR website. We significantly strengthened our financial position in August 2023 as we completed a private placement transaction, raising $100 million upfront and up to $50 million in additional funds if the warrants are fully exercised within 24 months.

GC007G 是 HLA 匹配供體來源的同種異體 CAR-T 療法，並未利用我們的 FasTCAR 和 TruUCAR-T 技術平台或 SMART CAR-T 模組。更新後的研發線圖表可在亙喜生物投資者關係 (IR) 網站上發布的公司介紹中找到。我們於 2023 年 8 月完成了一項私募交易，籌集了 1 億美元的預付款，如果認股權證在 24 個月內全部行使，還將獲得高達 5000 萬美元的額外資金，從而顯著增強了我們的財務狀況。

With the support from the top-tier roster in institutional investors, this capital raise extends our cash runway into the second half of 2026, assuming the full exercise of warrants and is intended to support us through critical upcoming milestones planned for the clinical development of GC012F in multiple myeloma and SLE. Now I will hand the call over to our CMO, Dr. Wendy Li, to highlight updated data from the ongoing IIT in MDMM. Wendy, please go ahead.

在頂級機構投資者的支持下，此次融資將使我們的現金流延長至2026年下半年（假設認股權證全部行使），並旨在支持我們完成GC012F在多發性骨髓瘤和系統性紅斑狼瘡（SLE）治療中的臨床開發中即將實現的關鍵里程碑。現在，我將把電話交給我們的行銷長李文迪博士，她將重點介紹正在進行的MDMM IIT的最新數據。李文迪，請開始吧。

Thank you, William. As highlighted, we are continuing to amass clinical evidence supporting the tremendous potential of our lead candidate, BCMA-CD19 dual-targeting FasTCAR-T GC012F. In late September at the IMS Annual Meeting, we presented long-term follow-up data from an ongoing Phase I IIT evaluating GC012F in newly diagnosed multiple myeloma. These patients have not received any anti-myeloma therapy before they are enrolled to our study. And all patients in this study had one or more high-risk features of which 89% were class 5 as Stage 2 or 3 based on the reverse international staging system and 63% extramedullary plasmacytoma.

謝謝，William。如同所強調的，我們正在持續累積臨床證據，以支持我們的主要候選藥物BCMA-CD19雙標靶FasTCAR-T GC012F的巨大潛力。 9月下旬，在IMS年會上，我們展示了正在進行的I期臨床試驗（IIT）的長期追蹤數據，該試驗旨在評估GC012F在新診斷多發性骨髓瘤中的療效。這些患者在納入我們的研究之前未接受過任何抗骨髓瘤治療。本研究中的所有患者均具有一項或多項高風險特徵，其中89%的患者根據逆向國際分期系統（IRS）被歸類為5級（即2期或3期），63%的患者為髓外漿細胞瘤。

GC012F demonstrated a 100% ORR and a 100% MRV-negative strengthened CR rate (inaudible) the 19 transplant-eligible, high-risk NDMM patients as of the data cutoff date of August 1, 2023. GC012F also continued to show a favorable safety profile with around 78% patients not having CRS of any grade and no patients reporting neurotoxicity or (inaudible). We think these data are highly competing suggesting a potentially ideal profile for the frontline application of CAR-T therapy, combining both steep response and high tolerability. In December, updated results from this ongoing study will be presented at the 65th ASH Annual Meeting.

截至2023年8月1日資料截止日期，GC012F在19例符合移植條件的高風險NDMM患者中顯示出100%的客觀緩解率（ORR）和100%的MRV陰性增強CR率（聽不清楚）。 GC012F也持續顯示出良好的安全性，約78%的患者未出現任何程度的CRS，且無患者報告神經毒性或（聽不清楚）。我們認為這些數據極具競爭力，顯示其可能是CAR-T療法第一線應用的理想方案，兼具快速緩解和高耐受性。這項正在進行的研究的最新結果將於12月在第65屆ASH年會上公佈。

As highlighted in the abstract available on the ASH website, we plan to share updated data, including 22 patients with the favorable efficacy and safety profile, consistent with fire data sets. The ASH data set includes 3 additional patients that were not in the IMS data set because those patients were not dosed or assessed when we first submitted the abstract to IMS. I will now hand the call over to our CFO, Dr. Yili Xie, Kevin?

正如ASH網站上的摘要所強調的，我們計劃分享更新的數據，其中包括22例療效和安全性良好的患者，與Fire數據集一致。 ASH資料集也包含3例IMS資料集中未收錄的患者，因為這些患者在我們首次向IMS提交摘要時尚未接受給藥或評估。現在，我將把電話交給我們的財務長謝一力博士，Kevin？

Thank you, Wendy. Turning to our financial results for the third quarter ended September 30, 2023, I'd like to touch on a few financial trends. As of September 30, 2023, the company had RMB 1,707.9 million or USD 234.1 million in cash and cash equivalents and short-term investments. We expect the cash use this year to be approximately USD 100 million, primarily to fund our R&D and clinical program in the U.S. and China.

謝謝，Wendy。談到我們截至2023年9月30日的第三季財務業績，我想談談一些財務趨勢。截至2023年9月30日，本公司持有17.079億元（約2.341億美元）現金及現金等價物及短期投資。我們預計今年的現金使用量約為1億美元，主要用於資助我們在美國和中國的研發和臨床計畫。

As announced in early August, we completed a private placement financing with $100 million risk upfront and up to an additional $50 million in the event that the warrants are fully exercised within 24 months after closing of the upfront purchase. With this, we have extended our cash run rate significantly and now expect our cash position to be sufficient to cover our operational plan and R&D activities into the second half of 2026 if the warrants are fully exercised. For the 3 months ended September 30, 2023, net loss attributable to ordinary shareholders were RMB 67.6 million or USD 9.3 million compared to RMB 171.9 million for the corresponding prior year period.

正如8月初宣布的那樣，我們完成了一筆私募融資，其中預付風險金額為1億美元，如果認股權證在預付購買完成後24個月內全部行使，則最高可獲得5000萬美元的額外風險金額。透過此次融資，我們大幅提高了現金運行率，如果認股權證全部行使，我們預計現金狀況將足以支持我們到2026年下半年的營運計畫和研發活動。截至2023年9月30日的三個月，歸屬於普通股股東的淨虧損為人民幣6,760萬元（約930萬美元），而去年同期為人民幣1.719億元。

The decline in net loss is primarily a result of a decrease in the fair value of warrant liabilities. The warrants issued in August private placement are measured and recorded at share value at the time of issuance. The fair value of the word decreased by RMB 39.9 million or USD 5.5 million as of September 30, 2023, and was recorded as a gain in the income statement. Research and development expenses for the 3 months ended September 30, 2023, were RMB 90.1 million or USD 12.3 million compared to RMB 133.4 million in the corresponding prior year period.

淨虧損的減少主要由於認股權證負債公允價值的下降。 8月私募發行的認股權證以發行時的股票價值計量併入帳。截至2023年9月30日，該認股權證的公允價值減少了人民幣3,990萬元（約550萬美元），併計入損益表的收益。截至2023年9月30日的三個月，研發費用為人民幣9,010萬元（約1,230萬美元），而去年同期為人民幣1.334億元。

The decrease was primarily due to the decrease spending on research, development and the clinical trial as a result of timing of project spending and our strategic pipeline alignment. With that, I'd like to turn it back to the operator to open the session for your questions. operator?

下降的主要原因是專案支出的時機和我們策略管線的調整導致研發和臨床試驗支出減少。好了，現在請接線生開始提問。接線生？

(Operator Instructions) Your first question comes from the line of Yigal Nochomovitz from Citi.

（操作員指示）您的第一個問題來自花旗銀行的 Yigal Nochomovitz。

You mentioned the antibody secreting cells in a certain population, maybe CD19 negative, which would be helpful with your dual construct. Could you provide a little more color on the percent of antibody secreting cells that may be CD19 negative.

您提到了特定群體中可能存在CD19陰性的抗體分泌細胞，這對您的雙重建構很有幫助。您能否更詳細地說明可能為CD19陰性的抗體分泌細胞的百分比？

Yes. It's a widely reported, but the percentage of CD19 negative ASC in humans we haven't found a very rounded reports, but it is a fact that there are antibodies secreting cells are CD19 negative for sure and BCMA positive. If you need I can send your reference for that?

是的。這方面的報導很廣泛，但我們還沒有發現關於人類CD19陰性ASC比例的全面報道，但確實存在一些抗體分泌細胞，它們肯定是CD19陰性，而BCMA陽性。如果您需要的話，我可以發給您的參考資料嗎？

Okay. That would be great. And then with the translational research you mentioned with the 4 patients, could you provide a little more quantification as to how much more B cell antibody suppression you saw with the dual construct versus the CD19 CAR-T alone?

好的。那太好了。然後，根據您提到的針對4名患者的轉化研究，您能否提供更量化的數據，說明雙構建體與單獨使用CD19 CAR-T相比，B細胞抗體抑製程度提高了多少？

The assay is at a spot. So basically, what it does is we take the BMC bone marrow cells from the patient prior to the treatment, after treatment. And we put these cells in the (inaudible) spot device with our CAR-T. RT is a treatment with the CAR-T ex vivo and see how many antibodies secreting spots that are formed. Based on that, the difference is CD19 single CAR and BCMC19 dual CAR GC012F is more than 10-fold.

這項檢測是在點位進行的。基本上，我們在治療前和治療後從患者體內提取骨髓細胞（BMC）。然後，我們將這些細胞和我們的CAR-T細胞一起放入（聽不清楚）點位裝置中。 RT是在體外進行CAR-T治療，觀察形成了多少個分泌抗體的點位。基於此，CD19單CAR和BCMC19雙CAR GC012F的差異超過10倍。

Okay. Got it. And then final question is, I was just curious. You mentioned William, you've treated, I think, 60 myeloma patients so far with 012. Were there any (inaudible)?

好的，明白了。最後一個問題，我只是好奇。你提到威廉，我記得你用012治療了60名骨髓瘤患者。有沒有（聽不清楚）？

No, 51 plus 9. 51 myeloma patients and 9 DLBCL patients.

不，是 51 加 9。51 名骨髓瘤患者和 9 名 DLBCL 患者。

Okay. So amongst those 60 in total, did any of those patients have an underlying autoimmune condition that may have improved with the treatment?

好的。那麼在這60名患者中，是否有任何患者患有潛在的自體免疫疾病，可以透過治療得到改善？

We have not paid attention that we discovered. Yes, we don't notice that there are a certain percentage of autoimmune patients but sometimes, it could happen for liquid tumor.

我們沒有註意到我們發現的現象。是的，我們沒有註意到有一定比例的自體免疫患者，但有時，液體腫瘤也會出現這種情況。

Your next question comes from the line of Benjamin Burnett from Stifel.

您的下一個問題來自 Stifel 的 Benjamin Burnett。

I also wanted to ask about the SLE study, some of the early signals you're seeing from the IIT cohorts. Encouraging to hear that B cells are recovering by 3 months. But I guess, can you talk about the degree of B-cell aplasia that you're seeing? Is this comparable to what you've seen in the ecology studies?

我還想問SLE研究，您從IIT隊列中觀察到的一些早期訊號。聽到B細胞在3個月內恢復，令人鼓舞。不過，可以談談您觀察到的B細胞發育不全的程度嗎？這與您在生態學研究中觀察到的情況類似嗎？

Compared with George (inaudible) study?

與喬治（聽不清楚）的研究相比？

Comparable to what you've seen with 12F in your myeloma studies just in terms of the amount of B cell aplasia?

僅從 B 細胞發育不全的數量來看，與您在骨髓瘤研究中看到的 12F 的情況類似嗎？

Yes. B cell depletion is similar, although the SLE study still needs to be further followed and evaluated. But what we're seeing is the declining mining curve is similar. And the recovery time or persistent of B cell depletion, we need to have more time to make a conclusion. B cell recovery so far from these 4 patients looks very similar to other SLE studies. Does that answer your question?

是的。 B 細胞耗竭的情況類似，儘管 SLE 研究仍需進一步追蹤和評估。但我們觀察到的下降曲線與此類似。至於 B 細胞耗竭的恢復時間或持續時間，我們需要更多時間才能得出結論。到目前為止，這 4 名患者的 B 細胞恢復情況與其他 SLE 研究非常相似。這回答了你的問題嗎？

Yes, that's great. I just wanted to just ask about the newly diagnosed multiple myeloma study. I think (inaudible) you've had is interesting. We're looking forward to the ASH update. But I guess could you maybe frame for us what the regulatory path is or could be in the U.S. for this asset in a newly diagnosed multiple myeloma (inaudible) what would constitute a pivotal study in this setting?

是的，太好了。我只是想問關於新診斷多發性骨髓瘤的研究。我覺得（聽不清楚）您做的研究很有趣。我們期待ASH的最新消息。不過，您能否為我們介紹一下，在美國，針對新診斷多發性骨髓瘤的這項藥物的監管途徑是什麼，或者說可能是什麼？ （聽不清楚）在這種情況下，什麼才算是一項關鍵性研究？

It's too early to give you that perspective, how do we decide design study for newly diagnosed and also pivotal studies. But based on our understanding of what the regulatory agencies view towards kind of a progressive development of CAR-T therapy to early lines it's all about safety and, of course, efficacy. And this product so far were convinced it's very robustly safe across different indications of late and early line of multiple myeloma and DLBCL, now SLE.

現在就給出這樣的觀點還為時過早，我們如何決定針對新診斷患者和關鍵性研究的設計研究？但根據我們對監管機構對CAR-T療法在早期治療領域逐步發展的看法的理解，安全性和療效是關鍵。到目前為止，我們確信該產品在多發性骨髓瘤、瀰漫性大B細胞淋巴瘤（DLBCL）和系統性紅斑狼瘡（SLE）等不同適應症的治療中都非常安全。

I think given the data we collected and when we have Ib MM study data, I think that will be the time we'll communicate with U.S. FDA. By the time we shall have a detailed design how we approach the early line or the first line, but we are not excluding anything. We definitely will move forward in the early lines for sure.

我認為，鑑於我們收集的數據，以及我們獲得Ib期MM研究數據後，我們就會與美國FDA溝通。屆時，我們將制定詳細的設計方案，並討論如何處理早期線或第一線治療，但我們不會排除任何可能性。我們肯定會在早期線方面取得進展。

Your next question comes from the line of Dingding Shi from Jefferies.

您的下一個問題來自 Jefferies 的施鼎鼎。

This is Dev on for Dingding Shi. So my question is on SLE. So maybe if you can set up an expectation what type of data company is planning to release in first half of '24. And related to that, what cell-dose level you are studying. And can it shorten the dose level that you will be studying in U.S. trials similar to RRMM or it will be those escalations starting from the smaller stores?

我是Dev，為Dingding Shi提問。我的問題是關於SLE的。您能否設定一個預期，公司計劃在2024年上半年發布哪些類型的數據？與此相關的是，您正在研究的細胞劑量水平是多少？它能否縮短您在美國類似RRMM試驗中研究的劑量水平，還是會從較小的樣本開始逐步增加劑量？

Yes. We are dosing SMO, SLE patient. So we expect it's going to be double digits when we presented data first half of 2024. We expect majority of patients will have at least 3 months and some of the patients will have 6 months evaluation. Now the dose, we started with the dose very similar that we have treated on MM patients or newly diagnosed patients, too. So I can't predict what's going to happen with those Level 3. But now we are dosing up to see what happened.

是的。我們正在給SMO和SLE患者用藥。我們預計2024年上半年公佈的數據會是兩位數。我們預期大多數患者至少需要3個月的觀察期，部分患者需要6個月的評估期。至於劑量，我們一開始的劑量和我們治療多發性骨髓瘤（MM）患者或新診斷患者的劑量非常相似。所以我無法預測3級患者的狀況。但現在我們正在增加劑量，看看會發生什麼。

And based on what we see today, it's very consistent. The PK and the CIS and (inaudible) just preliminary, it seems very similar. So we will move up to 3x10 to 5th, which is still very low compared to the others in the industry. And I don't expect to dose higher than 3x10 to 5th. But we'll see.

從我們今天看到的情況來看，結果非常一致。藥物動力學 (PK) 和 CIS 以及（聽不清楚）初步數據看起來非常相似。因此，我們將提升到 3x10 至 5 的劑量比例，但與業內其他公司相比，這個比例仍然很低。我預期劑量比例不會超過 3x10 至 5 的劑量比例。我們拭目以待。

Your next question comes from the line of Eric Schmidt from Cantor.

您的下一個問題來自 Cantor 的 Eric Sc​​hmidt。

A question around the SLE translational data. William, did all 4 patients achieve deep B-cell aplasia or deep B cell lymph cell depletion with no detectable B cells?

關於 SLE 轉換資料的一個問題。 William，這 4 名患者是否都出現了深部 B 細胞發育不全或深部 B 細胞淋巴細胞耗竭，且檢測不到 B 細胞？

B-cell aplasia after CAR-T therapy. That's what we can say. Your second half question is (inaudible) B cell aplasia after lymph cell depletion, no (inaudible) most of it not.

CAR-T療法後B細胞發育不全。我們可以這麼說。你的後半部問題是（聽不清楚）淋巴球耗竭後B細胞發育不全，不（聽不清楚）大部分情況下不會。

Okay. What flu side dose are you using?

好的。你服用的流感副作用劑量是多少？

It's very similar to Dr. Shez Group.

它與 Dr. Shez Group 非常相似。

Okay. And what was the duration?

好的。持續時間多長？

It's similar to multiple myeloma regime.

這與多發性骨髓瘤的治療方案類似。

The duration of the B-cell depletion was similar to what you've seen in myeloma?

B 細胞耗竭的持續時間與您在骨髓瘤中看到的相似嗎？

Lymph cell depletion is very similar. B cell aplasia, at this moment, I mean, the longest we have seen so far a couple of months of full after-CART infusion. So to make a claim that how long the B-cell aplasia, I think it's still too early. I mean complete recovery. I think it needs more time. Right now, the declining of B cells is very similar compared with multiple myeloma. But when are these patients comes back with a meaningful readouts, I think we need a couple of months to see. And then I have to remind that these first 4 patients are low doses. It's a onetime 10-5th per kilo. And now we're moving up to 2x to 10 to 5th and 3x 10 to 5th, so we need to give them an (inaudible).

淋巴球衰竭的情況非常相似。 B細胞發育不全，目前為止，我的意思是，我們見過的最長的CART後完全輸注時間是幾個月。所以，要斷言B細胞發育不全需要多長時間才能完全康復，我認為現在還為時過早。我的意思是完全康復。我認為需要更多時間。目前，B細胞的下降與多發性骨髓瘤非常相似。但這些患者何時能得到有意義的結果，我認為我們還需要幾個月的時間才能看到結果。然後我必須提醒一下，前4名患者接受的是低劑量治療。一次性劑量是每公斤10-5。現在我們正在提高到2倍10-5和3倍10-5，所以我們需要給他們（聽不清楚）。

I think you mentioned that you saw elimination of antibody secreting cells. Did you also measure autoantibodies themselves and see elimination of auto antibodies?

我記得您曾提到觀察到抗體分泌細胞的消除。您是否也測量了自身抗體本身，並觀察到自身抗體的消除？

Yes. I mean in vivo, I mean in human, we certainly measure as many types of auto antibody we can if those auto-antibodies are high over (inaudible) to therapy. Now what I mentioned is (inaudible) is ex vivo study. So we measure typical, for example, double stranded DNA antibody (inaudible) 20 auto antibodies to measure. For clinical, it's doable. For preclinical, we want to have a consistent system to compare. Sorry, I missed your second point.

是的。我的意思是在體內，也就是在人體中，如果自身抗體在治療過程中水平較高（聽不清楚），我們當然會盡可能地檢測各種類型的自身抗體。我提到的（聽不清楚）是體外研究。所以我們會檢測一些典型的自體抗體，例如雙股DNA抗體（聽不清楚），需要檢測20種自體抗體。對於臨床研究來說，這是可行的。對於臨床前研究，我們希望有一個一致的系統來進行對比。抱歉，我漏掉了你的第二點。

So in the SLE patients with double-stranded DNA antibodies, you did see those decline?

那麼在具有雙股 DNA 抗體的 SLE 患者中，您確實看到了這些下降嗎？

Yes. Although I do not want to give out any data related to efficacy. Yes.

是的。雖然我不想透露任何與療效相關的數據。是的。

Your next question comes from the line of Emily Bodnar from H.C. Wainwright.

您的下一個問題來自 H.C. Wainwright 的 Emily Bodnar。

There was an ASH abstract also on a dual CD19 BCMA CAR-T for SLE. I'm just curious if you've seen that and maybe if you can comment on some initial thoughts from there on the efficacy and safety side. And then if you could provide any guidance for timing on initial data for the Claudin 18.2 positive solid tumor study in China? And maybe if you could also talk about the design there?

ASH期刊上也有一篇關於雙CD19 BCMA CAR-T療法用於治療SLE的摘要。我很好奇您是否看過這篇摘要，能否就其療效和安全性方面發表一些初步看法？然後，您能否就中國Claudin 18.2陽性實體瘤研究的初始資料發佈時間提供一些指引？能否談談該研究的設計？

Thanks for the question. I mean, it's still early for us to release or to share the data especially efficacy, safety as you know, you're going to see safety in the first 28 days, it's unlikely the typical CIS and neurotox will happen after 15 days. So within 28 days, we are comfortable to share, even though it's, again, (inaudible), this is early data. It's the first low-dose onetime 10 to 5th per kilo. It's about $6 million total CAR-T cell, $6 million. But it's very, very encouraging. We see all the signs of safety and efficacy.

謝謝你的提問。我的意思是，現在發布或分享數據還為時過早，尤其是療效和安全性數據。如你所知，安全性會在最初的28天內顯現，典型的原發性骨髓瘤（CIS）和神經毒性不太可能在15天後出現。所以，在28天內，我們很樂意分享數據，儘管這（聽不清楚）只是早期數據。這是首次低劑量一次性注射，劑量為每公斤10到5毫克。 CAR-T細胞總成本約600萬美元。但這非常非常令人鼓舞。我們看到了所有安全性和療效的跡象。

Now a reasonable set of data readout will be the first half year 2024. By the time, we'll have double-digit patients with at least 3 months and hopefully half of the 6 months follow up. So that's what we should expect.

現在，一組合理的數據將在2024年上半年公佈。到那時，我們將擁有兩位數的患者，至少有3個月的追蹤記錄，並且希望有一半的患者能夠進行6個月的追蹤。所以，這就是我們應該期待的。

Sorry, I think maybe you misunderstood my question. I know there was an abstract that was released to be presented at ASH from another CD19 BCMA CAR-T therapy for SLE. I was just curious if you see that and what your thoughts were on what they present or what they showed in the abstract?

抱歉，我想你可能誤解了我的問題。我知道有一篇關於另一種針對系統性紅斑狼瘡 (SLE) 的 CD19 BCMA CAR-T 療法的摘要即將在 ASH 上發表。我只是好奇你是否看到了這份摘要，以及你對他們在摘要中展示的內容有何看法？

Yes. I saw that abstract that has been presented somewhere before. It is good to see another dual targeting CAR-T that is being applied to autoimmune disease. But every construct is different. We don't know the details of their construct, and we don't know much about background, particularly the safety of the same compound, the same CAR-T or other indications, for example, oncology. But based on what we saw from the abstract, the data looks reasonable.

是的。我看到過之前在某個地方發表過的摘要。很高興看到另一個雙標靶CAR-T療法被應用於自體免疫疾病。但每種療法的建構方式都不同。我們不清楚它們的建構方式細節，也不太了解背景訊息，尤其是相同化合物、相同CAR-T療法的安全性，或其他適應症，例如腫瘤學。但根據摘要的內容，數據看起來合理。

I think when we compare with Dr. (inaudible) group, the patient background is different. I think everybody would agree that the patients that this group tend to be younger and the time from the diagnosis is short. And this abstract seems the patients are more diversified. The Slenda index seems, I would say, similar because more than, I think, 10 patients. So the mean is similar, medium and similar. The age seems is more diversified. And then some patients with active lupus nephritis may not be fully recovered, which is not the price, in our opinion, because when in the real world, when the patients are older and the first time from the first diagnosis is much longer, and they have been treated more standard of care.

我認為，與醫生（聽不清楚）組相比，患者的背景有所不同。我想大家都會同意，這個組的患者往往更年輕，確診時間也更短。而這份摘要似乎顯示患者組成更加多樣化。 Slenda指數似乎相似，因為我認為超過10名患者。因此，平均值相似，中等和相似。年齡似乎更加多樣化。一些活動性狼瘡性腎炎患者可能無法完全康復，我們認為這並非代價，因為在現實世界中，當患者年齡較大時，首次確診的時間更長，他們接受的治療也更加標準化。

And if it depends on percentage of patients have active lupus nephritis, and that will give you a different flavor of readouts. And the last thing I want to remind everyone who is interested, you got to look into the product, the format of final product, whether it's a fresh CAR-T cells or it's frozen. As we all appreciate if it's frozen, CAR-T-cells is more, it is more robust in the real world for delivery for shipping and if anything happened to the patient right before the dosing that can be stored in the appropriate conditions. If it's a fresh store, it's going to be changed.

如果這取決於患有活動性狼瘡性腎炎的患者百分比，那麼結果就會有所不同。最後，我想提醒所有有興趣的人，務必仔細研究產品，最終產品的形式，無論是新鮮的CAR-T細胞還是冷凍的。眾所周知，冷凍的CAR-T細胞在現實世界中運輸時更穩定，即使患者在給藥前發生意外，也能在適當的條件下儲存。如果是新鮮儲存，情況就會改變。

Okay. That's helpful. And if you could just comment on the Claudin 18.2 positive study and when we might see initial data there?

好的。這很有幫助。您能否評論 Claudin 18.2 的積極研究，以及我們什麼時候可以看到初步數據？

Yes, we just launched. So there is really not much to share. Yes, I mean, any specific questions, would be happy to share with you.

是的，我們剛剛上線。所以真的沒什麼好分享的。是的，我的意思是，如果有任何具體問題，我很樂意和大家分享。

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

您的下一個問題來自富國證券的朱亞南。

I also have a question on the translational study for the SLE patient bone marrow ELISPOT assay. I was wondering whether the inhibition that you saw in assay was due to CD19 negative BCMA positive bone marrow cells? Or could it be due to greater inhibition of the CD19 positive cells. And also, I was wondering, is it possible to quantify the percentage of CD19 negative BCMA-positive cells ASCs in these bone marrow samples?

我還想問一個關於SLE患者骨髓ELISPOT檢測轉化研究的問題。我想知道您在檢測中觀察到的抑制是否是由於CD19陰性、BCMA陽性的骨髓細胞造成的？還是由於CD19陽性細胞的抑製程度更嚴重？另外，我想知道，能否量化這些骨髓樣本中CD19陰性、BCMA陽性細胞（ASC）的百分比？

Let me answer the first question. We do have a CD19 with the same sequence same binder from the GC012F. So the single CAR C19 CAR in comparison with the dual CAR. So the comparison is very clear. If the inhibition of CD19 positive cells by the dual CAR, yes, we can always suspect when a single CAR become a dual CAR, it might change certain characteristics by at least from the single binding perspective, the dual targeting, in theory should hit CD19 and BCMA.

我來回答第一個問題。我們確實有來自GC012F的CD19，其序列和結合物都相同。所以單CAR-C19 CAR與雙CAR-C19 CAR的比較結果非常清晰。如果雙CAR-C19 CAR抑制CD19陽性細胞，是的，我們總是可以猜測，當單CAR-C19 CAR變成雙CAR-C19 CAR時，它可能會改變某些特性，至少從單CAR-C19 CAR結合的角度來看是如此。理論上，雙CAR-C19 CAR應該同時作用於CD19和BCMA。

So the effect of what we see is more than additive. It's about 10x. So either it's additive or synergistic because dual targeting, we need to do more studies to illustrate that. But the observation is very clear. The dual targeting does inhibit autoantibody secreting spots significantly. What was your second question?

所以我們看到的效果不只是疊加，而是大約10倍。所以它要么是疊加的，要么是協同的，因為雙重靶向，我們需要做更多的研究來證明這一點。但觀察結果非常明確。雙重靶向確實顯著抑制了自身抗體分泌點。你的第二個問題是什麼？

Is it possible to quantify the percentage of CD19 additive BCMA-positive ASCs in these standpoints?

從這些角度來看，是否有可能量化 CD19 添加 BCMA 陽性 ASC 的百分比？

Good question. We are doing it. It's a variable a lot among patient to patient, as you would so far, we collected for patients, which is not easy to collect the bone marrow cells from those treated patients, but we need more data.

問得好。我們正在做這件事。不同患者之間存在很大差異，就像你到目前為止所做的那樣，我們為患者採集骨髓細胞，從接受治療的患者身上採集骨髓細胞並不容易，但我們需要更多數據。

Got it. And then I was wondering if you could provide any update on the partnership front, both regarding the myeloma perhaps as well as the new SLE initiative?

明白了。然後，我想知道您能否提供一些關於合作方面的最新消息，包括骨髓瘤以及新的系統性紅斑狼瘡（SLE）計劃？

Yes. We continue to engage the conversation with potential partners. They are promised interest in both oncology and immunology and our particular partners only interested in immunology. That's all as much as I can share. But yes, we are very engaging conversations.

是的。我們持續與潛在合作夥伴進行交流。我們承諾他們不僅對腫瘤學感興趣，還會對免疫學感興趣，而我們的伴侶只對免疫學感興趣。我能分享的就這麼多了。不過，我們的交流確實非常正面。

Your next question comes from the line of Joseph Catanzaro from Piper Sandler.

您的下一個問題來自 Piper Sandler 的 Joseph Catanzaro。

Maybe 2 for me. First one, William, I think I heard you say that you're going to have a presentation at the cell therapy for autoimmune disease summit later this month. Just wondering maybe if you could elaborate a little bit on what you expect to present there? Will there be any more additional translational work from these first 4 patients that we might see there? And then my second question, I know it sounds like you continue to expect the U.S. myeloma study to complete enrollment in about 9 to 10 months. Just wanted to know if you have any updated thoughts around when you may have an initial data disclosure from that study?

對我來說可能是兩個。第一個問題，威廉，我記得你說過你將在本月稍後的自身免疫性疾病細胞療法高峰會上做一個報告。能否詳細說說你​​預計在高峰會上會展示哪些內容？我們可能會在高峰會上看到這4名患者的更多轉化研究嗎？第二個問題，我知道你預計美國骨髓瘤研究將在9到10個月內完成患者入組。我想知道，你對何時可能披露該研究的初始數據有什麼最新想法嗎？

Yes. Regarding the translational studies, I think the data to be presented at the summit is going to be similar what I said. I think it's another 10 days from now or less than 10 days. So I don't think you should expect a significantly more information from our presentation. We're in Ib for our MM trial in the U.S. We have to wait the EOP1 and Phase I report submit to FDA and consensus discussion with them for next phase. So I don't believe that we can release data prior to that, but that's my understanding. But as far as for the study, it's ongoing, so far so good.

是的。關於轉化研究，我認為高峰會上展示的數據應該和我之前說的差不多。我想大概還要10天，或不到10天。所以我認為你不應該期待我們的演示會提供太多資訊。我們在美國進行的MM試驗目前處於Ib階段。我們必須等待EOP1和I期報告提交給FDA，並與他們進行共識討論，才能進入下一階段。所以我認為我們無法在此之前發布數據，但這是我的理解。至於研究本身，它仍在進行中，目前一切順利。

Your next question comes from the line of Justin Zelin from BTIG.

您的下一個問題來自 BTIG 的 Justin Zelin。

So on the SLE data for the update, can you remind us what we should expect, obviously, safety and what we should expect from a clinical efficacy standpoint?

那麼，關於更新的 SLE 數據，您能否提醒我們應該期待什麼，顯然是安全性，以及從臨床療效的角度來看我們應該期待什麼？

Expect, meaning predict, so far, all I can say so far so good and took time to have a meaningful efficacy data for safety because it comes in short, coming within 15 days, you could much see them all. Neurotox takes a couple of more weeks, but so far, again, it's our impression or I can say, it's not really data. I mean impression is very consistent what we've seen before. Yes. I mean, as I answered the question of the other caller, next year, you should expect double digits of patients.

預期，也就是預測，到目前為止，我只能說一切都很好，而且花了時間才獲得有意義的安全性有效性數據，因為它來得很快，15天內就能見效，你很可能就能看到所有結果。 Neurotox 還需要幾週時間，但到目前為止，這只是我們的印象，或者說，它並非真正的數據。我的意思是，我們的印象與我們之前看到的非常一致。是的。我的意思是，正如我回答另一位來電者的問題時所說，明年，預計患者數量將達到兩位數。

The readout on double-digit patients will be mostly at least 3 months and some of them will be 6 months, which is more meaningful. And our patients are very diversified. I think it's actually it's a real world. The SLEDAI index is based on SLEDAI is for patients having more severe SLE and that age order, and that's all I can say at this moment.

兩位數患者的讀數大多至少為3個月，有些為6個月，更有意義。我們的患者非常多樣化。我認為這實際上是一個現實問題。 SLEDAI指數是基於SLEDAI針對更嚴重的SLE患者和年齡順序的，目前我只能說這麼多。

Great. And maybe, William, if you could just give us an idea of what you would think an impactful durability would be for a CAR-T for SLA. I think that would be helpful?

太好了。威廉，您能否跟我們講一下，您認為CAR-T療法治療SLA的耐久性應該達到什麼樣的水平？我想這會很有幫助。

Yes. I mean, that's an interesting question Justin. I mean this is a very difficult to answer. It's a balance between the length or the persistence of B-cell depletion. But in the meantime, you don't want to be disappear for too long, but you wanted the B cell coming back with new phenotype, young phenotype and (inaudible) B-cell reset and how long is good enough. I think our theory is we always see in oncology side, we always see very deep B-cell depletion.

是的。賈斯汀，這個問題很有趣。這個問題很難回答。關鍵在於B細胞耗竭的持續時間和持續時間之間的平衡。但同時，你不希望B細胞消失太久，但你希望B細胞能夠以新的表型、年輕的表型和（聽不清楚）B細胞重置的方式回歸，以及多長時間才算足夠好。我認為我們的理論是，在腫瘤學領域，我們總是看到非常嚴重的B細胞耗竭。

And what's translating to readout is the MRD negativity. It's always just (inaudible) so we expect B cell aplasia in immunology will be very deep as well. But how long particularly, what is the persistence we want. We'll see. I mean we are doing dose escalation, and we'll evaluate in of course, the efficacy.

轉化為讀數的是MRD陰性。它總是（聽不清楚），所以我們預期免疫學中的B細胞發育不全也會非常嚴重。但具體來說，我們希望持續多久？我們拭目以待。我的意思是，我們正在進行劑量遞增，當然，我們會評估療效。

We have no further questions in our queue at this time. I will now turn the call back over to Dr. William Cao's closing remarks.

目前我們沒有其他問題。現在我將把節目轉回給威廉·曹博士，請他做最後發言。

Thank you again to everyone for joining us on the call. We are focused on advancing our highly differentiated and most competitive candidates, including the FasTCAR GC012F. The U.S. IND trial in RRMM is now underway, and we look forward to submitting the IND filings in the U.S. and China for the planned Phase I clinical trial in R-SLE this year. We remain committed to pushing the boundaries of medical innovation and improving patient outcomes through our transformative therapies.

再次感謝各位參加此次電話會議。我們專注於推進我們高度差異化且最具競爭力的候選藥物，包括FasTCAR GC012F。目前，針對復發/復發多發性骨髓瘤（RRMM）的美國IND試驗正在進行中，我們期待今年在美國和中國提交針對R-SLE的I期臨床試驗的IND申請。我們將繼續致力於突破醫療創新的界限，並透過我們的變革性療法改善患者的治療效果。

This concludes today's conference call. Thank you for your participation, and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，現在可以掛斷電話了。