Atara Biotherapeutics Inc (ATRA) 2023 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning, and thank you for standing by. Welcome to Atara Biotherapeutics' third-quarter 2023 financial results conference call. (Operator Instructions) Please be advised that today's call is being recorded. I would now like to hand the call over to Alex Chapman, Vice President of Corporate Communications and Investor Relations at Atara Biotherapeutics. Please go ahead, sir.

    早安,感謝您的支持。歡迎參加 Atara Biotherapeutics 2023 年第三季財務業績電話會議。 (操作員指示)請注意,今天的通話正在錄音。現在,我想將電話交給 Atara Biotherapeutics 公司企業傳播和投資者關係副總裁 Alex Chapman。先生,請繼續。

  • Alex Chapman - VP, Corporate Communications & IR

    Alex Chapman - VP, Corporate Communications & IR

  • Thank you, Cheri. Good morning, everyone, and welcome to Atara's conference call to discuss our expanded tab-cel global partnership with Pierre Fabre Laboratories and our third-quarter 2023 update. Earlier today, we issued a press release announcing this partnership and our third-quarter financial results. This press release and an updated slide deck are available in the investors and media section at atarabio.com.

    謝謝你,Cheri。大家早安,歡迎參加 Atara 的電話會議,討論我們與 Pierre Fabre Laboratories 擴大的 tab-cel 全球合作夥伴關係以及我們 2023 年第三季度的最新情況。今天早些時候,我們發布了一份新聞稿,宣布了這項合作關係以及我們的第三季財務表現。本新聞稿和更新的幻燈片可在 atarabio.com 的投資者和媒體部分找到。

  • Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer, and Eric Hyllengren, Chief Financial Officer. (Event Instructions)

    參加今天電話會議的還有總裁兼執行長 Pascal Touchon 博士和財務長 Eric Hyllengren。 (活動須知)

  • We would like to remind listeners that during the call, the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings.

    我們想提醒聽眾,在電話會議期間,公司管理層將發表前瞻性陳述。由於與公司業務相關的風險和不確定性,實際結果可能與我們的前瞻性陳述所明示或暗示的結果有重大差異。這些前瞻性陳述完全受到今天的新聞稿和公司向美國證券交易委員會提交的文件中所含警示性聲明的限制。

  • These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now, I'd like to turn the call over to Pascal. Pascal?

    這些聲明均截至今日為止,本公司不承擔更新這些聲明的義務。現在,我想把電話轉給帕斯卡。帕斯卡?

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you, Alex, and thank you all for joining us this morning. Today, we announced the global expansion of our tab-cel partnership with Pierre Fabre Laboratories, whoare already successfully launching this product across Europe.

    謝謝你,亞歷克斯,也謝謝大家今天早上加入我們。今天,我們宣布與 Pierre Fabre Laboratories 擴大 tab-cel 的全球合作,他們已經在歐洲成功推出了該產品。

  • In parallel, we announced a strategic restructuring that together with the expanded tab-cel partnership, will expand Atara planned cash runway into Q3 2025. This positions us well to continue building the value of our pipeline, including through anticipated clinical milestones for ATA188 with the EMBOLD readout in early November, as well as initial data for the ATA3219 program in lymphoma.

    同時,我們宣布了一項策略重組,加上擴大的 tab-cel 合作夥伴關係,將使 Atara 的計劃現金流量延長至 2025 年第三季。這使我們能夠繼續建立我們產品線的價值,包括透過 11 月初 EMBOLD 讀數的 ATA188 預期臨床里程碑,以及淋巴瘤 ATA3219 項目的初步數據。

  • Now I'll start by covering the details of the partnership and strategic restructuring, followed by upcoming clinical milestones. After a competitive process with significant interest from across the spectrum of large pharma, midsized pharma, and biotech companies, we are excited to announce an expanded partnership with Pierre Fabre to commercialize tab-cel in the U.S. and all remaining global markets.

    現在我將首先介紹合作夥伴關係和策略重組的細節,然後介紹即將到來的臨床里程碑。經過一系列競爭,並得到了來自大型製藥公司、中型製藥公司和生物技術公司的濃厚興趣,我們很高興地宣布擴大與皮爾法伯的合作夥伴關係,在美國和所有其他全球市場實現 tab-cel 的商業化。

  • This moment signifies a pivotal transition in Atara's evolution. We are now optimally positioned as a nimble, allogeneic T-cell immunotherapy company with near-term catalysts and the opportunity to advance a pipeline of differentiated therapies across a range of oncology and autoimmune indications from our proven EBV T-cell platform.

    這一刻標誌著 Atara 進化的關鍵轉折。現在,我們已處於最佳定位,成為一家靈活的同種異體 T 細胞免疫療法公司,擁有近期催化劑和機會,可以透過我們成熟的 EBV T 細胞平台,推進一系列針對一系列腫瘤學和自體免疫適應症的差異化療法。

  • We sought a partner that is committed to deliver tab-cel, a product with life-saving potential, tothe U.S. and global patients. In parallel, we pursued a deal structure that meaningfully reduces our cash burn over the next two years and provides Atara and shareholders with significant value, both through short-term cash and potential milestone payments and long-term significant double-digit royalties.

    我們尋求一個致力於向美國和全球患者提供具有救命潛力的產品 tab-cel 的合作夥伴。同時,我們尋求一種交易結構,可以顯著減少未來兩年的現金消耗,並透過短期現金和潛在的里程碑付款以及長期兩位數的特許權使用費為 Atara 和股東提供重大價值。

  • Pierre Fabre brings substantial and demonstrated capabilities evidenced by the successful launch of tab-cel, branded as Ebvallo in European markets. We have found them to be committed collaborators, providingcompelling justification to expand our partnership for tab-cel to reach as many patients as possible worldwide. Specific to the U.S., which is the largest commercial opportunity, Pierre Fabre is in a strong position to succeed, strengthening their U.S. presence with tab-cel as their flagship product and building onto their marketing experience in Europe.

    皮爾法伯擁有雄厚且經過驗證的能力,其在歐洲市場成功推出以 Ebvallo 為品牌的 tab-cel 就是明證。我們發現他們是忠誠的合作者,這為擴大我們的合作夥伴關係提供了令人信服的理由,使 tab-cel 能夠惠及全球盡可能多的患者。具體到擁有最大商業機會的美國,皮爾法伯佔據有利地位,能夠以 tab-cel 作為旗艦產品加強其在美國的影響力,並鞏固其在歐洲的營銷經驗。

  • Now for the specifics. Atara will receive up to $640 million in additional consideration, plus significant double-digit tiered royalties on net sales. As part of the deal, we will receive approximately $30 million at deal closing in upfront and inventory purchases, and $100 million more in potential regulatory milestone payments through potential BLA approval.

    現在來談談具體細節。 Atara 將獲得高達 6.4 億美元的額外對價,外加淨銷售額的兩位數分級特許權使用費。作為交易的一部分,我們將在交易完成時獲得約 3000 萬美元的預付款和庫存採購款,並透過潛在的 BLA 批准獲得 1 億美元的潛在監管里程碑付款。

  • In addition, Pierre Fabre will reimburse Atara for expected tab-cel global development costs through BLA approval and will purchase existing and future tab-cel inventory through the BLA transfer date. Substantially all tab-cel manufacturing, regulatory and development activities are targeted to transition from Atara to Pierre Fabre at the time of the BLA transfer.

    此外,皮爾法伯將透過 BLA 批准向 Atara 償還預期的 tab-cel 全球開發成本,並將在 BLA 轉讓日期之前購買現有和未來的 tab-cel 庫存。在 BLA 轉讓時,幾乎所有 tab-cel 製造、監管和開發活動都將從 Atara 轉移到 Pierre Fabre。

  • We remain confident that tab-cel represents a significant business opportunity with several hundred EBV-positive PTLD addressable patients in the U.S. alone, who could benefit from this potentially life-saving therapy with a favorable safety profile. With significant pricing potential based on its value for patients and health care system in such an ultra-rare disease, we believe that tab-cel has the potential to deliver U.S. peak sales of over $500 million per year, following potential label expansion from the multi-cohort study.

    我們仍然相信,tab-cel 代表著一個巨大的商機,僅在美國就有數百名 EBV 陽性 PTLD 患者可以從這種具有良好安全性且可能挽救生命的療法中受益。由於 tab-cel 對於這種極其罕見的疾病患者和醫療保健系統的價值,它具有巨大的定價潛力,我們相信,在多隊列研究的潛在標籤擴展之後,tab-cel 有可能在美國實現每年超過 5 億美元的峰值銷售額。

  • With future sales milestones and significant double-digit royalties through our agreement with Pierre Fabre, we believe U.S. tab-cel commercialization will progressively grow future revenues for Atara over the term of the agreement. As we continue to evolve as an organization focused on developing innovative allogeneic cell therapies for cancer and autoimmune diseases, we are undertaking a strategic restructuring to reduce our current workforce by approximately 30%. The benefits of the expanded tab-cel partnership, coupled with the restructuring, are anticipated to reduce our planned cash expenditures from 2023 levels, by approximately 40%, or $100 million, by the end of 2025.

    透過與 Pierre Fabre 達成的協議,我們相信,憑藉未來的銷售里程碑和高達兩位數的特許權使用費,美國 Tab-Cel 商業化將在協議期限內逐步增加 Atara 的未來收入。隨著我們作為一個專注於開發癌症和自體免疫疾病的創新同種異體細胞療法的組織不斷發展,我們正在進行策略重組,以將現有員工人數減少約 30%。擴大 tab-cel 合作夥伴關係的好處加上重組預計將使我們的計劃現金支出在 2025 年底前從 2023 年的水平減少約 40%,即 1 億美元。

  • I would like to extend my sincere gratitude to all Atara staff, both those continuing to the next phase for Atara and those departing, for their unwavering commitment to the patients' lives we seek to transform and their significant contributions in advancing truly innovative medicines for patients in need. Thank you for what you have done to get us where we are today.

    我要向所有 Atara 員工表示誠摯的謝意,無論是繼續為 Atara 效力的員工還是即將離職的員工,感謝他們對我們努力改變的患者生活的堅定承諾以及為向有需要的患者提供真正創新藥物所做的重大貢獻。感謝您為我們取得今天的成就所做的一切。

  • We believe these actions, when combined with cash of approximately $102 million on September 30, 2023, and certain anticipated payments from the expanded tab-cel commercial partnership, will be sufficient to fund Atara's planned operations into Q3 2025. This will position Atara well to deliver on multiple anticipated clinical milestones, including the early November EMBOLD data readout, as well as key data readouts for the ATA3219 program in lymphoma and potentially in autoimmune diseases.

    我們相信,這些行動加上 2023 年 9 月 30 日約 1.02 億美元的現金以及擴大的 tab-cel 商業合作夥伴關係中的某些預期付款,將足以資助 Atara 到 2025 年第三季度的計劃運營。這將使 Atara 能夠很好地實現多個預期的臨床里程碑,包括 11 月初的 EMBOLD 數據讀數,以及淋巴瘤和潛在自體免疫疾病的 ATA3219 項目的關鍵數據讀數。

  • On the regulatory front, we are encouraged from the recent positive FDA assessment of comparability that supports pooling the pivotal clinical data from different process versions of tab-cel in the BLA submission, expected in Q2 2024.

    在監管方面,FDA 最近對可比性做出了積極的評估,這讓我們感到鼓舞,該評估支持在 BLA 提交中匯總來自不同工藝版本的 tab-cel 的關鍵臨床數據,預計將於 2024 年第二季度提交。

  • We now have a clear plan for the clinical data package, and the expected BLA submission timing aligns with our filing strategy to include the latest pivotal ALLELE study data for inclusion in, and to robustly support, both the pre-BLA meeting and anticipated BLA filing package. We are also excited to disclose initial data from our Phase 2 multi-cohort study in various EBV-positive cancer in December at ESMO-IO.

    我們現在對臨床數據包有一個明確的計劃,預計的 BLA 提交時間與我們的備案策略一致,以包括最新的關鍵 ALLELE 研究數據,以納入並大力支持 BLA 前會議和預期的 BLA 備案包。我們也很高興在 12 月的 ESMO-IO 上披露針對各種 EBV 陽性癌症的 2 期多隊列研究的初步數據。

  • Now onto ATA188, our potentially transformative therapy for people living with progressive multiple sclerosis. The primary analysis readout for the Phase 2, double-blind placebo-controlled EMBOLD study is on track for early November, which will include the primary outcome measure of confirmed disability improvement by EDSS and the relevant imaging and fluid biomarkers for more than 90 patients.

    現在介紹 ATA188,這是我們針對進行性多發性硬化症患者的潛在變革性療法。第二階段雙盲安慰劑對照 EMBOLD 研究的主要分析讀數將於 11 月初發布,其中將包括透過 EDSS 確認的殘疾改善的主要結果測量以及 90 多名患者的相關影像和液體生物標記。

  • This includes a number of patients that enrolled earlier in the study and have been evaluated beyond the primary endpoint of 12 months, at 15, 18, 21, and 24 months. The EDSS data from these later timepoints will be analyzed as part of the primary analysis and may give a sense of ATA188 impact on EDSS stability and progression, which usually requires longer follow-up time to assess that disability improvement.

    這包括一些早期參與研究的患者,並且在 12 個月的主要終點之後,在 15、18、21 和 24 個月進行了評估。這些後期時間點的 EDSS 數據將作為主要分析的一部分進行分析,並可能提供 ATA188 對 EDSS 穩定性和進展的影響,這通常需要更長的追蹤時間來評估殘疾的改善。

  • Our goal is to disclose sufficient study data to allow investors to evaluate the potential value of ATA188 in non-active progressive MS. As a reminder, significant unmet need remains in progressive MS, especially non-active progressive MS, which represents the vast majority of the progressive MS population and is the focus of the EMBOLD study.

    我們的目標是揭露足夠的研究數據,以便投資者評估 ATA188 在非活動性進行性 MS 中的潛在價值。需要提醒的是,進行性 MS,尤其是非活動性進行性 MS,仍然存在大量未滿足的需求,非活動性進行性 MS 佔進行性 MS 人群的絕大多數,也是 EMBOLD 研究的重點。

  • There are no approved therapies right now that have demonstrated disability improvement for non-active progressive MS. The currently approved therapies only demonstrate modest slowing of disability progression with an approximately 6% difference versus placebo that is primarily driven by patients with active disease.

    目前尚無任何核准的療法能夠證明能夠改善非活動性進行性 MS 的殘疾狀況。目前核准的療法僅能適度減緩殘疾進展,與安慰劑相比差異約為 6%,這主要由患有活動性疾病的患者造成。

  • As a result, anything better than this, ranging from more slowing of progression, to stabilization of disability, to trends for disability improvement, to significant improvement, is potentially transformative and sets up diverse and robust clinical development opportunities, including potential pivotal Phase 3 trials.

    因此,任何比這更好的情況,從進一步減緩病情進展,到穩定殘疾狀況,到殘疾狀況改善趨勢,到顯著改善,都可能帶來變革,並建立多樣化和強勁的臨床發展機會,包括潛在的關鍵性 3 期試驗。

  • Finally, we are progressing our potential best-in-class allogeneic CAR-T assets, which could play a foundational role in our portfolio moving forward. We will focus resources in the near term on clinical development of ATA3219, following recent IND clearance, and on preclinical activities for ATA3431, our CD19-CD20 targeted CAR-T.

    最後,我們正在推進潛在的最佳同種異體 CAR-T 資產,這可能在我們未來的產品組合中發揮基礎性作用。我們將在短期內集中資源進行 ATA3219 的臨床開發(近期獲得 IND 批准)以及 ATA3431(我們的 CD19-CD20 靶向 CAR-T)的臨床前活動。

  • While these are the programs that have the highest potential for value creation over the next two years, we will also continue to strategically invest in other attractive targets and platform enhancements. With respect to ATA3219, our allogeneic CAR-T for B-cell malignancies expressing CD19, we are progressing to activate study centers and start enrolling patients in the coming months, in a Phase 1 study in relapsed or refractory B-cell NHL. We expect preliminary clinical data in the second half of 2024.

    雖然這些項目在未來兩年內具有最高的價值創造潛力,但我們也將繼續對其他有吸引力的目標和平台增強進行策略性投資。關於 ATA3219,我們用於表達 CD19 的 B 細胞惡性腫瘤的同種異體 CAR-T,我們正在啟動研究中心並在未來幾個月開始招募患者,進行復發或難治性 B 細胞 NHL 的 1 期研究。我們預計 2024 年下半年將獲得初步臨床數據。

  • We are particularly excited to bring this allogeneic CD19 CAR-T asset to the clinic, as its been optimized to offer a potential best-in-class product profile, featuring off-the-shelf availability and clinically validated technologies like the 1XX signaling domain associated with favorable response rate and durability, enrichment for a less differentiated T-cell memory phenotype for improved clinical responses, and retention of the endogenous T cell receptor, which may be a crucial survival signal for T cells.

    我們特別高興將這種同種異體 CD19 CAR-T 資產帶入臨床,因為它已經過優化,可提供潛在的最佳產品配置,具有現成的可用性和臨床驗證的技術,例如與良好的響應率和持久性相關的 1XX 信號域、富集分化程度較低的 T 細胞記憶表型以改善臨床反應,以及保留內源性 T 細胞受體,這可能是 T 細胞的關鍵生存率。

  • We are also pleased that ATA3431, an allogeneic bispecific CAR directed against CD19 and CD20, built on the EBV T-cell platform with the 1XX costimulatory domain, is moving into IND-enabling studies with a competitive profile. Compared to an autologous CD19/CD20 CAR-T benchmark, preclinical data demonstrate potent antitumor activity, long-term persistence, and superior tumor growth inhibition. And this has been accepted for poster presentation at the upcoming ASH meeting in December.

    我們也很高興看到,ATA3431,一種針對 CD19 和 CD20 的同種異體雙特異性 CAR,建立在具有 1XX 共刺激結構域的 EBV T 細胞平台上,正在進入具有競爭力的 IND 支持研究。與自體 CD19/CD20 CAR-T 基準相比,臨床前數據顯示其具有強大的抗腫瘤活性、長期持久性和優異的腫瘤生長抑製作用。而該作品已被接受在即將於 12 月舉行的 ASH 會議上進行海報展示。

  • Beyond oncology, there has been high interest recently in the potential of CAR-T cell therapies for autoimmune disease with remarkable results from early data in patients living with severe refractory disease such as lupus. At Atara, we have believed for a while in the important role cell therapies can play in addressing autoimmune conditions. With ATA188, Atara is pioneering the use of an allogeneic T-cell immunotherapy in a neurological autoimmune condition.

    除了腫瘤學之外,最近人們對 CAR-T 細胞療法治療自體免疫疾病的潛力產生了濃厚的興趣,早期數據顯示,該療法在患有狼瘡等嚴重難治性疾病的患者中取得了顯著成果。在 Atara,我們一直相信細胞療法在治療自體免疫疾病方面可以發揮重要作用。憑藉 ATA188,Atara 率先在神經系統自體免疫疾病中使用同種異體 T 細胞免疫療法。

  • Building on this experience, we're actively considering options best suited for Atara's allogeneic CAR-T EBV therapies in autoimmune diseases. Our EBV T cells have compelling potential benefits like persistence and favorable safety with no requirement for complex genetic editing. Specifically, they possess a memory phenotype and can expand and traffic to sites of disease, which provide a versatile platform with off-the-shelf accessibility that can address several potential shortcomings of other approaches. To that end, we're actively progressing efforts toward a potential IND to evaluate ATA3219 in autoimmune disease in parallel with NHL development. More to come on that soon.

    基於此經驗,我們正在積極考慮最適合 Atara 同種異體 CAR-T EBV 療法治療自體免疫疾病的方案。我們的 EBV T 細胞具有引人注目的潛在優勢,例如持久性和良好的安全性,且無需進行複雜的基因編輯。具體來說,它們具有記憶表型,可以擴展和運輸到疾病部位,這提供了一個具有現成可訪問性的多功能平台,可以解決其他方法的幾個潛在缺點。為此,我們正在積極推動潛在的 IND 努力,以評估 ATA3219 在治療自體免疫疾病和 NHL 方面的作用。很快我們會發布更多相關資訊。

  • To close, we are excited about the near-term opportunities for Atara to demonstrate the potential of our pipeline. We are coming up to one of the most exciting milestones in Atara's history with the primary analysis readout of the EMBOLD study very soon, and we are now well capitalized with planned cash runway into Q3 2025 to pursue our potential best-in-class portfolio of CAR T assets in areas of great unmet need where we believe we can make the biggest difference.

    最後,我們對 Atara 近期展示其產品線潛力的機會感到非常興奮。隨著 EMBOLD 研究的主要分析結果即將公佈,我們即將迎來 Atara 歷史上最激動人心的里程碑之一,現在我們已擁有充足的資金,計劃在 2025 年第三季度擁有充足的現金流,以便在我們認為能夠發揮最大作用的、存在巨大未滿足需求的領域追求我們潛在的最佳 CAR T 資產組合。

  • I will now turn the call over to the operator for the Q&A part of the call. Operator?

    現在我將把電話轉給接線員,進行問答部分。操作員?

  • Operator

    Operator

  • (Operator Instructions) Salim Syed, Mizuho.

    (操作員指示)Salim Syed,瑞穗。

  • Salim Syed - Analyst

    Salim Syed - Analyst

  • Great. Good morning, guys. Congrats on the deal. Just a couple of from me, if I can. One on the process. Pascal, you mentioned that there were large pharma players involved here. Just curious, the rationale to go with Pierre Fabre, was it just more operational that you wanted just one partner globally? Was that just really important to you? Or was that also financially driven? Did Pierre Fabre actually offer greater economics?

    偉大的。大家早安。恭喜交易成功。如果可以的話,我只想說幾句。一個是關於過程。帕斯卡,您提到這裡有大型製藥公司參與。只是好奇,選擇 Pierre Fabre 的理由是,是否因為你們希望在全球範圍內只與一個合作夥伴,這樣更具可操作性?這對你來說真的很重要嗎?還是這也是出於經濟原因?皮爾法伯是否真的提供了更好的經濟效益?

  • And then second, just on the $500 million number that you put up for US peak sales, just curious if you could break that down for us, even ballpark wise? How much of that is for the first indication EBV for PTLD? And just what portion of the $640 million in milestones could you get just on the first indication alone, potentially? Ballpark would be helpful. Thank you.

    其次,就您提出的美國最高銷售金額 5 億美元這一數字而言,您能否為我們詳細解釋一下,哪怕是大概的數字?其中有多少是用於 PTLD 的第一個適應症 EBV?那麼,僅憑第一個跡象,您就有可能獲得 6.4 億美元里程碑中的多少份額?球場會很有幫助。謝謝。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you, Salim, for your questions. So the first one, competitive process, a big pharma, mid pharma and biotech. Decision was based on three key aspects. One, of course, is financial. And financial not only about an upfront level, but very importantly, the way for us to be able to add the partner progressively taking over activities, but immediately taking over the cost of the activities for tab-cel. That was very important for us, because that was the way for us to really move into focusing our cash into the development in MS and in allogeneic CAR-Ts. So that was one aspect on financial.

    謝謝薩利姆的提問。第一個是競爭過程,大型製藥公司、中型製藥公司和生技公司。該決定基於三個關鍵方面。其中一個當然是財務方面。財務不僅涉及前期水平,而且非常重要的是,我們能夠逐步增加合作夥伴接管活動,但立即接管 tab-cel 活動的成本。這對我們來說非常重要,因為這是我們真正將資金集中到 MS 和同種異體 CAR-T 開發的方式。這是財務的一個面向。

  • The other one was the level of commitment that this particular partner is demonstrating through the process of diligence, and with Pierre Fabre, we have experience. We know how committed they are to the success of Ebvallo in Europe.

    另一個是該特定合作夥伴透過盡職調查過程所展現的承諾水平,並且我們與皮爾法伯有經驗。我們知道他們對 Ebvallo 在歐洲的成功有多麼的投入。

  • And then thirdly, it's true that I think only one partner is much easier to manage for us as a biotech company. It was not the most important decision point. But it was really an important aspect to say if the financials are exciting because they cover exactly what we need, in terms of taking over the cost and adding cash to the balance sheet. On top of that, I think someone who is truly committed to succeed in having tab-cel as their flagship product in the U.S., they're going to put 100% and even more effort behind it. Then, of course, the fact that I think only one partner makes it easier to manage, in general.

    第三,我確實認為,作為一家生技公司,只有一個合作夥伴對我們來說更容易管理。這不是最重要的決策點。但這確實是一個重要的方面,因為財務狀況是否令人興奮,因為它們完全滿足了我們的需求,即承擔成本和增加資產負債表上的現金。最重要的是,我認為真正致力於將 tab-cel 打造成美國旗艦產品的人會為此付出 100% 甚至更多的努力。當然,我認為整體來說只有一個合作夥伴更容易管理。

  • Now onto your second question, the $500 million peak sales, as we said, is linked with different type of indications. So first indication in second-line PTLD -- EBV-positive PTLD and additional indications coming from the multi-cohort study that is coming. By the way, we've announced that there will be some [preliminary] data presented at ESMO-IO in December. So that's the way the $500 million peak sales is progressively build up there in the US, in the way we see the potential of that product commercially.

    現在回到您的第二個問題,正如我們所說,5 億美元的峰值銷售額與不同類型的跡像有關。因此,二線 PTLD 的首要適應症是 EBV 陽性 PTLD,而其他適應症則來自即將進行的多隊列研究。順便說一句,我們已經宣布將在 12 月的 ESMO-IO 上展示一些[初步]數據。這就是我們在美國逐步實現 5 億美元高峰銷售額的方式,我們看到了該產品的商業潛力。

  • Now on the milestone that the sales milestones are not related to a specific indication, just sales milestones. And we're not going to disclose exactly what the detail of the sales milestone, but we think that they are reasonable in the approach that we're taking in terms of what is the potential of the product and how that potential is leveraged. Does it answer your question?

    現在,關於里程碑,銷售里程碑與特定指標無關,僅與銷售里程碑有關。我們不會透露銷售里程碑的具體細節,但我們認為,就產品的潛力以及如何利用這種潛力而言,我們採取的方法是合理的。它回答了你的問題嗎?

  • Salim Syed - Analyst

    Salim Syed - Analyst

  • Got it. Sort of. I'm happy to rephrase it, if that's okay. But if you can't answer, I understand that as well.

    知道了。有點。如果可以的話,我很樂意重新表達它。但如果你無法回答,我也能理解。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • (multiple speakers) we cannot disclose more on the milestones. That's my point.

    (多位發言者)我們無法透露更多有關里程碑的資訊。這就是我的觀點。

  • Salim Syed - Analyst

    Salim Syed - Analyst

  • Okay. I guess just for the $500 million though, how much of that is weighted on the first indication alone, I guess, was the question. And (multiple speakers) PTLD (multiple speakers)

    好的。我想,就這 5 億美元而言,問題在於其中有多少是基於第一個跡象的。以及(多位發言者)PTLD(多位發言者)

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • I think it's a significant part because we always say it's several hundred patients in the first indication. And we also say that we have, we believe, a significant pricing potential based not only on the expense in Europe, where the pricing you have in Europe today, the listed part is about $640,000 or the equivalent of $640,000 dollars.

    我認為這是一個重要的部分,因為我們總是說第一個適應症就是幾百名患者。我們還說,我們相信,我們擁有巨大的定價潛力,這不僅基於歐洲的費用,目前歐洲的定價,列出的部分約為 64 萬美元或相當於 64 萬美元。

  • And usually, the difference between the U.S. and Europe is up 30% to 40% for this type of product. That gives you an idea. We don't know what Pierre Fabre will say for the price, but we've been discussing that with them and we think they will try [elected] they are doing in Europe to optimize the pricing potential in line with the value that the product is giving to patients in the health care system. But also, we've had a lot of discussion as Atara with payers in the US, and we know exactly what's a price sensitivity and what the price that will be considered as acceptable to offer significant coverage of the patients.

    通常,美國和歐洲之間的此類產品價格差額高達30%至40%。這給了你一個想法。我們不知道皮爾法伯對價格會作何評價,但我們一直在與他們討論這個問題,我們認為他們會嘗試(選舉)他們在歐洲的做法,以根據該產品給醫療保健系統中的患者帶來的價值來優化定價潛力。但是,作為 Atara,我們也與美國的付款人進行了大量討論,我們確切地知道什麼是價格敏感度,以及什麼樣的價格才被認為是可以接受的,以便為患者提供大量的保險。

  • We talked about the number of patients. We're confident about the price. And we're seeing by itself, this is going to create -- to reach a significant part of that $500 million.

    我們討論了病人的數量。我們對價格很有信心。我們看到,這將會創造——達到那 5 億美元中的很大一部分。

  • Salim Syed - Analyst

    Salim Syed - Analyst

  • Got it. Thank you so much, Pascal. Congrats again.

    知道了。非常感謝,帕斯卡。再次恭喜。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • John Newman, Canaccord Genuity.

    約翰紐曼,Canaccord Genuity。

  • John Newman - Analyst

    John Newman - Analyst

  • Hi, there. Thanks for taking my question, and congrats on a nice deal here. So my question is regarding the tab-cel regulatory process. Just curious, Pascal, if you could just give us an update on the new clinical data or the additional clinical data that will be included when you file the application in 2024?

    你好呀。感謝您回答我的問題,並祝賀您在這裡達成了一筆不錯的交易。我的問題是關於 tab-cel 監管流程的。只是好奇,帕斯卡,您是否可以向我們提供有關新臨床數據或在 2024 年提交申請時將包含的附加臨床數據的最新資訊?

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Yeah, certainly. So when we reached the alignment and agreement on comparability, that was when we could then organize a new data cut for the ALLELE study, the pivotal study. So that has been on -- in October. And now we're going to have all the typical time needed to get the data clean, to get the IORA assessment we do have the scans and so on. And that will give us a new set of data compared with the one we presented in December '22 at ASH on 43 patients.

    是的,當然。因此,當我們在可比性方面達成一致和一致時,我們就可以組織新的資料剪切,用於 ALLELE 研究,即關鍵研究。事情已經發生了——在十月。現在我們將有足夠的時間來清理資料、取得 IORA 評估、進行掃描等等。這將為我們提供一組新的數據,與我們在 2022 年 12 月在 ASH 上針對 43 名患者展示的數據相比。

  • So that new set of data will then be in the typical way put together, presented to the agency at the pre-BLA meeting and then move on to the BLA submission. So the time needed is really the time to clean up the data. We're very confident in these data, and we've many reasons to be very confident in this data. But one that you all know is about the fact that whatever the type of study, whatever the process versions we've used in the past, and we've treated more than 400 patients with tab-cel across different diseases and more than 260 patients in PTLD -- in EBV-positive PTLD, so we have a very significant data package and experience.

    因此,新的資料集將以典型的方式匯總在一起,在 BLA 前會議上提交給該機構,然後繼續進行 BLA 提交。所以所需的時間其實就是清理資料的時間。我們對這些數據非常有信心,而且我們有很多理由對這些數據非常有信心。但大家都知道,無論研究類型如何,無論我們過去使用過什麼流程版本,我們都已經用 tab-cel 治療了 400 多名不同疾病的患者和 260 多名 PTLD 患者——EBV 陽性 PTLD,因此我們擁有非常重要的資料包和經驗。

  • But whatever that study, whatever the process versions, we always have found similar results from an efficacy and safety point of view. So very similarefficacy with that and in terms of overall response rate, long-term efficacy with good persistence of the response, and then, of course, favorable safety. So that's why we feel extremely confident about this new data that will be put together and discussed with the agency.

    但無論研究內容是什麼,無論過程版本如何,從功效和安全性的角度來看,我們總是會發現類似的結果。因此,其療效非常相似,並且就整體反應率、長期療效和良好的反應持久性而言,當然,安全性也很好。因此,我們對將與該機構匯總和討論的這些新數據非常有信心。

  • Does it answer your question?

    它回答了你的問題嗎?

  • John Newman - Analyst

    John Newman - Analyst

  • It does. I just had one additional question on ATA188. Just curious, obviously, the data will be coming here shortly, but I'm wondering if you could discuss your thoughts on the commercial plans for that product, if you're considering a partnership, if you're planning on marketing the product on your own, if perhaps partnership is being considered for only Europe? Just curious there. Thanks.

    確實如此。我還有一個關於 ATA188 的問題。只是好奇,顯然,數據很快就會出來,但我想知道您是否可以討論一下您對該產品商業計劃的想法,您是否正在考慮合作,是否計劃自己營銷該產品,是否只考慮在歐洲建立合作夥伴關係?只是好奇。謝謝。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you for your question. So it depends on the next step. But if indeed, we are to the point where the next step is to move to Phase 3. As we disclosed in the past, we have already discussed with the FDA about the type of Phase 3 that they would like to see when we obtained two fast-track designations, and that's where the agency mentioned two Phase 3. One in non-active PPMS. One in non-active SPMS.

    感謝您的提問。所以這取決於下一步。但如果確實如此,我們下一步就是進入第 3 階段。正如我們過去所揭露的那樣,當我們獲得兩個快速通道資格時,我們已經與 FDA 討論過他們希望看到的第 3 階段類型,而該機構提到了兩個第 3 階段。一個是非活性 PPMS。一個在非活動 SPMS 中。

  • And the reason they asked for two instead of just one is mainly because the medical need is slightly different in the U.S. in these two potential indications because in non-active SPMS, which is, by the way, the vast majority of the patients with SPMS, with secondary progressive MS, in that particular population, there is no approved therapy in the US. Whereas, the non-active PPMS, there is officially one approved therapy -- recently approved therapy, which is Ocrevus there. So that's why there is unmet medical need from a fast-track and potential BTD type of status later on. So we'll discuss with the agency.

    他們之所以要求兩種而不是一種,主要是因為美國對這兩種潛在適應症的醫療需求略有不同,因為對於非活動性 SPMS,順便說一下,絕大多數 SPMS 患者患有繼發性進行性 MS,而在美國,還沒有批准的治療方法。然而,對於非活性 PPMS,有一種官方批准的療法——最近批准的療法,即 Ocrevus。這就是為什麼快速通道和以後潛在的 BTD 類型的狀態存在未滿足的醫療需求。因此我們將與該機構進行討論。

  • These two Phase 3 studies will be also put together with a Phase 2 program to go in earlier stage of MS and maybe some other autoimmune indications. All that will be a very significant clinical development program that we believe will benefit from having a strategic partner that could bring financial and operational capabilities to be able to run all of the studies in parallel.

    這兩項 3 期研究也將與 2 期計劃結合起來,用於治療 MS 的早期階段以及其他一些自體免疫症狀。我們相信,這一切都將是一個非常重要的臨床開發項目,如果擁有一個能夠帶來財務和營運能力的策略合作夥伴,能夠同時進行所有研究,該項目將受益匪淺。

  • So I'd say the idea will be to consider partnership, but not a pure licensing out, more of a strategic co-development. Maybe we have some options for other activities, especially in the US, and that's really the aim being to activate rapidly this next stage of the development at the same time to retain significant value within Atara.

    所以我認為我們的想法是考慮合作,但不是純粹的許可,更多的是策略性的共同開發。也許我們還有其他活動的選擇,特別是在美國,而這實際上是為了迅速啟動下一階段的發展,同時保留 Atara 內部的重大價值。

  • And we've discussed in the past that the type of partnership we've profit split, particularly in the US, which is about 75% to 80% of the world market for MS, could make sense for the company and our shareholders. So too early to say what type of partnership and how we will implement that. But certainly something that we have been actively considering and discussing with a large number of big pharma companies over the last couple of years.

    我們過去曾討論過,我們利潤分割的合作類型,特別是在美國,佔多發性硬化症全球市場的 75% 至 80%,對公司和我們的股東來說都是有意義的。因此,現在談論我們將建立何種類型的夥伴關係以及如何實施這種夥伴關係還為時過早。但毫無疑問,過去幾年我們一直在積極考慮並與許多大型製藥公司討論此事。

  • John Newman - Analyst

    John Newman - Analyst

  • Great. Thank you for taking my questions.

    偉大的。感謝您回答我的問題。

  • Operator

    Operator

  • Phil Nadeau, Cowen and Company.

    菲爾‧納多 (Phil Nadeau),考恩公司 (Cowen and Company)。

  • Phil Nadeau - Analyst

    Phil Nadeau - Analyst

  • Good morning. Congratulations on the expanded partnership. A couple of questions from us. First, in terms of the royalty that you're going to get from Pierre Fabre, any -- can you give us any more information on magnitude of that royalty? Is it a graded royalty in any sense of the royalty range?

    早安.祝賀合作夥伴關係的擴大。我們有幾個問題。首先,關於您將從皮爾法伯獲得的版稅,您能否向我們提供更多有關版稅數額的信息?從版稅範圍來看,它是一種分級版稅嗎?

  • And then second, follow-up on the EMBOLD trial. Could you talk us through your current thought process as you -- as how you'd frame the go, no-go decision post the EMBOLD data? What do you need to see in EMBOLD to advance 188 into those two Phase 3 trials? Thanks.

    其次,跟進 EMBOLD 試驗。您能否向我們講講您目前的想法過程—在 EMBOLD 資料發布後,您將如何制定繼續或不繼續的決定?您需要在 EMBOLD 中看到什麼才能將 188 推進到這兩個 3 期試驗?謝謝。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you for your questions. So the first one, unfortunately, we cannot say more than significant double-digit tiered royalties, and it's an agreement with our partner Pierre Fabre that is not willing for us to disclose the royalty level. So we cannot say more than significant double-digit tiered royalties. And let's say that we are very pleased with that deal.

    感謝您的提問。因此,不幸的是,第一個問題我們不能透露超過兩位數分級版稅的具體數額,而且我們與合作夥伴 Pierre Fabre 達成了一項協議,他們不願意讓我們透露版稅水平。因此,我們無法說出超過兩位數分級版稅的數字。我們可以這麼說,我們對這筆交易非常滿意。

  • Now on your second question, the way we see the different scenarios, as we explained in the past, is as follows. We believe that if we have a significant statistical result on top of an impactful clinical result in terms of showing a percentage of CDI or confirmed disability improvers in active versus placebo, in that case, we will be a -- with a significant p, we will be considering moving into Phase 3. But it could be also the case, if it is not significant p, but very strong trend supported by a number of additional data from other clinical measures from imaging biomarkers such as MTR, magnetization transfer ratio, or some additional biomarkers.

    關於您的第二個問題,正如我們過去所解釋的那樣,我們對不同情境的看法如下。我們相信,如果我們在有影響力的臨床結果的基礎上,又獲得了顯著的統計結果,即顯示活性藥物與安慰劑相比,CDI 的百分比或確認的殘疾改善,在這種情況下,我們將——具有顯著的 p,我們將考慮進入第 3 階段。但也可能出現這種情況,如果它不是顯著的 p,但卻是非常強勁的趨勢,並得到來自成像生物標誌物(如 MTR、磁化轉移率或一些額外的生物標誌物)的其他臨床測量的大量額外數據的支持。

  • So I think a strong trend supported by these type of biomarkers and additional clinical data could also make the case for moving into Phase 3. So that's the type of scenario where we'll move to Phase 3.

    因此,我認為這些類型的生物標記和額外的臨床數據支持的強勁趨勢也可能為進入第 3 階段提供基礎。這就是我們將進入第 3 階段的情境類型。

  • The scenario where we would not move to Phase 3 in this specific indication of non-active progressive MS would be a scenario where we have evidence of effect, but that there is a need either to continue the study to the end as it is a two-year study or to be able to have data for example on stability on a larger number of patients. We'll have already data on stability and the ability to limit the progression of disability, but we might want to have more patients and to have all the patients reaching a two-year timepoint. We might also have some particular signal -- strong signal in subgroups of patients based on the data.

    對於這種非活動性進展型 MS 的特定適應症,我們不會進入第 3 階段,這種情況是,我們有效果的證據,但需要繼續進行研究,因為這是一項為期兩年的研究,或者需要能夠獲得數據,例如關於大量患者的穩定性的數據。我們已經擁有關於穩定性和限制殘疾進展的能力的數據,但我們可能希望有更多的患者,並讓所有患者達到兩年的時間點。根據數據,我們可能還會在患者亞群中發現一些特定的訊號—強烈的訊號。

  • So all that could lead to the need to continue some additional work for EMBOLD, expansion of EMBOLD, or just a continuation of EMBOLD, or some other studies that we could do to be able then to be in a stage where we could move to Phase 3.

    因此,所有這些都可能導致需要繼續為 EMBOLD 進行一些額外的工作、擴展 EMBOLD,或者只是繼續 EMBOLD,或者我們可以進行一些其他研究,以便能夠進入第 3 階段。

  • So that's the best way probably to answer your question right now is if it is statistical significance of very strong trend backed by biomarkers and other data, there is a clear path to move into Phase 3 following end of Phase 2 meeting with the agency and scientific advice in Europe. If it is something that shows evidence of effect, which, by the way, will be a big first and truly transformational already, because nobody has ever shown in such a large study that there is evidence of effect versus placebo that could be a significant signal to be able to explore further or continue the study till it ends. So that particular scenario will require some additional work, but we are well positioned to do that work.

    因此,現在回答你的問題最好的方式可能是,如果它具有統計意義,並且趨勢非常強勁,並且有生物標誌物和其他數據支持,那麼在第 2 階段與該機構的會議結束並獲得歐洲的科學建議後,就有一條明確的途徑進入第 3 階段。如果它顯示出有效的證據,順便說一句,這將是一個重大的首次,並且已經是真正的變革,因為從來沒有人在如此大規模的研究中證明有證據表明與安慰劑相比有效,這可能是一個重要的信號,可以進一步探索或繼續研究直到結束。因此,這種特殊情況將需要一些額外的工作,但我們已做好準備來完成這項工作。

  • Phil Nadeau - Analyst

    Phil Nadeau - Analyst

  • That's very helpful. Congratulations again and thanks for taking our questions.

    這非常有幫助。再次恭喜您並感謝您回答我們的問題。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Jonathan Miller, Evercore ISI.

    喬納森·米勒(Jonathan Miller),Evercore ISI。

  • Jonathan Miller - Analyst

    Jonathan Miller - Analyst

  • Hey, guys. Congrats so much on the tab-cel deal. We're really looking forward to MS data coming out, obviously. I would love to get a little bit deeper into the, I guess, the pipeline and the runway from here. So you mentioned there, certain anticipated payments included in the cash runway to '25 there. Is BLA approval included in that runway? For instance, what are the certain anticipated payments that you're counting explicitly and what are you not counting?

    嘿,大家好。非常恭喜您與 Tab-cel 達成交易。顯然,我們非常期待 MS 數據的發布。我想,我很想更深入地了解這裡的管道和跑道。所以您提到,某些預期付款包含在 25 年的現金流量中。該跑道是否包含 BLA 批准?例如,您明確計算的預期付款有哪些,又沒有計算哪些?

  • And secondly, how much of the CAR-T programs, the oncology program trial initiations are counted in the runway and how much of those trials are covered versus not covered with your current expectation?

    其次,CAR-T 計畫、腫瘤學計畫試驗啟動中有多少被計入,以及這些試驗中有多少被覆蓋,有多少沒有被覆蓋,這符合您目前的預期?

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you for your questions, Jon. So in terms of the expected payment from the deal, this is really around the regulatory milestone. It's not on the milestone at approval, it's through approval. We have a number of steps, that if successfully achieved, will be linked with payments. So that's why we say $100 million, regulatory milestones, through regulatory approval.

    謝謝你的提問,喬恩。因此,就交易預期支付而言,這確實與監管里程碑有關。這不是在批准時的里程碑,而是透過批准。我們採取了一系列措施,如果成功實現,將與付款掛鉤。這就是為什麼我們說 1 億美元是監管里程碑,是透過監管部門的批准。

  • That includes the BLA approval, by the way. But it's not the only milestone. There are a number of milestones before the BLA approval that could lead to payment from Pierre Fabre based on the progress we're making on the regulatory front. So that's to answer your first question.

    順便說一下,這包括 BLA 批准。但這並不是唯一的里程碑。在 BLA 批准之前,還有許多里程碑事件,根據我們在監管方面的進展,這些里程碑事件可能會導致 Pierre Fabre 付款。這就是回答你的第一個問題。

  • On your second question, what we are putting together in this cash runway expectation is the start, as we are doing right now, of our study in lymphoma with ATA3219, is also starting the study in autoimmune disease as we believe that there is a great potential for that product in autoimmune diseases like lupus, and we're working on that right now, and is also the IND-enabling studies for 3431, which is a very exciting, very competitive CD19/CD20 allogeneic CAR-T.

    關於您的第二個問題,我們在這個現金流預期中所做的就是開始 ATA3219 在淋巴瘤方面的研究,同時也開始了在自身免疫性疾病方面的研究,因為我們相信該產品在治療狼瘡等自身免疫性疾病方面具有巨大的潛力,我們現在正在研究這個問題,同時也在進行 3431 的 IND 支持研究,這是一種非常令人興奮、非常有競爭力的 CD19/CD20 同種異體 CAR-T。

  • But then, of course, we have EMBOLD that is continuing. Because even though we're going to present very soon the 12 months readout, the study, as you know, is continuing up to two years. So we have a number of patients that have reached over the two years, but many that have not yet reached two years. So we'll be able to continue that till next year, of course.

    當然,我們的 EMBOLD 計劃仍在繼續。因為儘管我們很快就會公佈 12 個月的讀數,但正如你所知,這項研究將持續長達兩年。因此,我們有許多患者已經達到兩年以上的年齡,但也有許多患者尚未達到兩年。因此,我們當然可以繼續這樣做到明年。

  • So all that is part of the expenses. Knowing that on the tab-cel front, the expenses are mostly covered by Pierre Fabre. Does it answer your question?

    所以這些都是費用的一部分。據了解,在 Tab-cel 方面,費用主要由 Pierre Fabre 承擔。它回答了你的問題嗎?

  • Jonathan Miller - Analyst

    Jonathan Miller - Analyst

  • Yeah, that's very helpful. Thank you.

    是的,這非常有幫助。謝謝。

  • Operator

    Operator

  • Salveen Richter, Goldman Sachs.

    薩爾文·里克特,高盛。

  • Unidentified Participant

    Unidentified Participant

  • Thanks so much for taking our questions. This is Tommy on for Salveen, and congrats on the deal. So with the closing in December and the workforce reduction, can you kind of walk us through what the financial impact will be until year end, if any? And on the MS release, how much detail do you expect to provide here, will be more so just p-values or could we actually see the trends and more quantitative measures too? Thank you so much.

    非常感謝您回答我們的問題。我是 Salveen 的 Tommy,祝賀交易成功。那麼,隨著 12 月的關閉和裁員,您能否向我們介紹到年底為止的財務影響(如果有的話)?關於 MS 發布,您希望提供多少細節,僅僅是 p 值還是我們實際上也能看到趨勢和更多定量指標?太感謝了。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Eric, do want to take the first question? I'll take the second one.

    艾瑞克,你想回答第一個問題嗎?我要第二個。

  • Eric Hyllengren - SVP, CFO

    Eric Hyllengren - SVP, CFO

  • Yeah, absolutely. So Tommy, the way we're looking at it, obviously, there's going to be -- I mean, we signed the deal, but then there's going to be the customary HSR review, which we don't expect to be a problem, so figure kind of a December effective date there. So benefits of the upfront payment inventory purchases, it's going to be right around end of December, early January, depending on that in the payment terms.

    是的,絕對是如此。所以湯米,從我們的角度來看,顯然,將會有——我的意思是,我們簽署了協議,但隨後將進行慣常的 HSR 審查,我們預計這不會是個問題,因此可以確定 12 月的生效日期。因此,預付款庫存採購的好處是,付款時間將在 12 月底或 1 月初左右,具體取決於付款條款。

  • And then yes, the 30% reduction in force, obviously there's the lower head count benefit, but then that's offset by some severance, of course, for those folks. So I would expect, you know, the main -- you'd look at the main benefits to begin in 2024 as a step down and then another step down in 2025 as we fully transition regulatory development and manufacturing activities over to Pierre Fabre.

    是的,裁員 30% 顯然會帶來員工人數減少的好處,但對這些員工來說,這當然會被一些遣散費所抵消。因此,我預計,您會看到,主要的好處是從 2024 年開始逐步減少,然後在 2025 年再次逐步減少,因為我們將監管開發和製造活動完全轉移到 Pierre Fabre。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • And on to your second question, so what we say so far that we plan to disclose sufficient data for investors to be able to have a better understanding of the value created by that study and for that particular asset. So it's difficult to say exactly what we'll disclose but depends on the data. But you can expect more than just the primary analysis of the 12 months' confirmed disability improvement active versus placebo. And as you know, there will be data on beyond 12 months because we have a number of patients that will have been evaluated at 15, 18, 21, 24 months, not only confirmed disability improvement, but also CDP, confirmed disability progression, to see what's happening on the stability front.

    關於您的第二個問題,到目前為止,我們所說的是我們計劃披露足夠的數據,以便投資者能夠更好地了解該研究和特定資產所創造的價值。因此很難說我們到底會揭露什麼,但取決於數據。但您可以期待的不僅僅是對 12 個月內證實的殘疾改善情況的活性藥物與安慰劑的初步分析。如您所知,我們將有 12 個月以後的數據,因為我們有許多患者將在 15、18、21、24 個月時接受評估,不僅確認殘疾改善,而且還確認 CDP,即殘疾進展,以了解穩定性方面的情況。

  • And then there will be imaging biomarkers, MRI, . And MTR, in particular, the biomarker we presented from our Phase 1 a couple of years ago that show that sign of remyelination within the chronic lesions in the brain of the patients that were improving on the treatment, we can expect that type of data as well. And then, of course, a number of other types of clinical and potential biomarkers.

    然後將會出現成像生物標記、MRI。尤其是 MTR,這是我們幾年前在第一階段研究中提出的生物標誌物,它顯示了在治療過程中病情有所好轉的患者大腦慢性病變中存在髓鞘再生的跡象,我們也可以期待獲得這類數據。當然,還有許多其他類型的臨床和潛在生物標記。

  • So ideally, we'd like to give enough information for investors to be able to have an understanding of what's the value created by the study so far and for this particular product, and of course, to try to also disclose what we see as the next step for the program. Does it answer your question?

    因此,理想情況下,我們希望向投資者提供足夠的信息,使他們能夠了解迄今為止這項研究為該特定產品創造的價值,當然,我們也試圖披露我們認為該計劃的下一步是什麼。它回答了你的問題嗎?

  • Unidentified Participant

    Unidentified Participant

  • Thanks so much.

    非常感謝。

  • Pascal Touchon - President and CEO

    Pascal Touchon - President and CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • That concludes our question-and-answer session for today. Thank you for joining Atara Biotherapeutics' third-quarter 2023 financial results conference call. You may now disconnect.

    今天的問答環節到此結束。感謝您參加 Atara Biotherapeutics 2023 年第三季財務業績電話會議。您現在可以斷開連線。