Shattuck Labs Inc (STTK) 2023 Q3 法說會逐字稿

Good morning and welcome to the Shattuck Labs third-quarter 2023 earnings conference call. (Operator Instructions)

早安，歡迎參加沙特克實驗室 2023 年第三季財報電話會議。 （操作員說明）

As a reminder, this conference call is being recorded. I will now turn the call over to your host, Conor Richardson, Vice President of Investor Relations at Shattuck Labs. Conor, please go ahead.

謹此提醒，本次電話會議正在錄音中。現在我將把電話轉給主持人、嘉德實驗室投資者關係副總裁康納理查森 (Conor Richardson)。康納，請繼續。

Thank you, operator. Good morning, everyone, and welcome to the Shattuck Labs conference call regarding our third-quarter 2023 financial results and recent business updates. The press release reporting our financial results was issued pre-market this morning and can be found on the Investor Relations section of our website, shattucklabs.com.

謝謝你，接線生。大家早安，歡迎參加沙特克實驗室關於我們 2023 年第三季財務業績和近期業務更新的電話會議。報告我們財務業績的新聞稿於今天上午盤前發布，可在我們網站 shattucklabs.com 的投資者關係部分找到。

During this morning's call, the Shattuck leadership team will provide a business overview of the third-quarter 2023, including clinical development updates. Speaking on today's call will be our Chief Executive Officer and Scientific Co-Founder, Dr. Taylor Schreiber; our Chief Medical Officer, Dr. Lini Pandite; and our Chief Financial Officer, Mr. Andrew Neill. We will then open the call for questions following our prepared remarks.

在今天早上的電話會議中，嘉德領導團隊將提供 2023 年第三季的業務概覽，包括臨床開發更新。我們的執行長兼科學聯合創始人 Taylor Schreiber 博士將在今天的電話會議上發言。我們的首席醫療官 Lini Pandite 博士；以及我們的財務長安德魯·尼爾先生。然後，我們將在準備好的發言後開始提問。

Before we begin, I would like to remind you that today's webcast contains forward looking statements within the meaning of Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve certain risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.

在我們開始之前，我想提醒您，今天的網路廣播包含1995 年《私人證券訴訟改革法案》安全港條款含義內的前瞻性陳述。此類陳述代表管理層截至今天的判斷，可能涉及某些風險和不確定性，可能導致實際結果與這些陳述中明示或暗示的結果有重大差異。

rFor more information on these risks and uncertainties, please refer to our most recent quarterly report on Form 10-Q for the quarter ended September 30, 2023, and our other filings with the SEC, which are available from the SEC's website or on our corporate website, shattucklabs.com. Any forward-looking statements represent our views as of today, November 9, 2023.

有關這些風險和不確定性的更多信息，請參閱我們截至2023 年9 月30 日的季度的最新10-Q 表格季度報告以及我們向SEC 提交的其他文件，這些文件可從SEC 網站或我們公司的網站上取得。網站，shattucklabs.com。任何前瞻性陳述均代表我們截至今天（2023 年 11 月 9 日）的觀點。

With that, I will now turn the call over to Dr. Schreiber, our Chief Executive Officer. Taylor?

現在，我將把電話轉給我們的執行長施賴伯博士。泰勒？

Thank you, Conor. Good morning, everyone, and thank you for joining us today. We are very pleased that our lead clinical stage product candidate, SL-172154, has advanced to a stage where we are able to begin sharing clinical data from both our hematologic and solid tumor programs.

謝謝你，康納。大家早安，感謝您今天加入我們。我們非常高興我們的主要臨床階段候選產品 SL-172154 已進入能夠開始共享血液學和實體腫瘤計畫臨床數據的階段。

Importantly, we are also pleased to have observed our first responses and efficacy data across our clinical trials, including our Phase 1B clinical trial in platinum-resistant ovarian cancer and our Phase 1A/B clinical trial in acute myeloid leukemia or high-risk myelodysplastic syndromes. We look forward to providing more details throughout the call.

重要的是，我們也很高興在我們的臨床試驗中觀察到我們的首批反應和療效數據，包括我們針對鉑類抗藥性卵巢癌的1B 期臨床試驗以及針對急性髓性白血病或高危險群骨髓增生異常綜合徵的1A/B 期臨床試驗。我們期待在整個通話過程中提供更多詳細資訊。

For the rest of the call, we will refer to SL-172154 as 154. This morning. We will discuss interim data from our Phase 1b clinical trial of 154 in combination with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer.

在剩下的通話中，我們將在今天早上將 SL-172154 稱為 154。我們將討論 154 例聚乙二醇化脂質體阿黴素治療鉑抗藥性卵巢癌患者的 1b 期臨床試驗的中期數據。

In addition, we will discuss the encouraging data from our ongoing Phase 1A/B clinical trial in acute myeloid leukemia or high-risk myelodysplastic syndromes that was described in an abstract released last week and will be presented at the American Society of Hematology annual meeting in early December.

此外，我們還將討論正在進行的急性髓性白血病或高風險骨髓增生異常綜合徵1A/B 期臨床試驗的令人鼓舞的數據，這些數據在上週發布的摘要中進行了描述，並將在2017年舉行的美國血液學會年會上公佈。十二月初。

These data include dose escalation data for 154 as monotherapy and in combination with azacitidine in primarily relapsed refractory AML and higher-risk MDS patients. As a reminder, 154 is a dual-sided fusion protein. It inhibits the CD47 checkpoint receptor and also directly activates immune cells by CD40 engagement. The CD47 landscape has evolved significantly over the past 18 months. Several advanced programs have encountered significant challenges with toxicity, including destructive anemia.

這些數據包括 154 種單藥治療以及與阿扎胞苷聯合治療原發性復發難治性 AML 和高風險 MDS 患者的劑量遞增數據。提醒一下，154 是一種雙面融合蛋白。它抑制 CD47 檢查點受體，也透過 CD40 結合直接活化免疫細胞。 CD47 格局在過去 18 個月中發生了顯著變化。一些先進的計畫遇到了毒性方面的重大挑戰，包括破壞性貧血。

These safety issues and the related clinical challenges have led to significant skepticism regarding the potential clinical utility of the CD47 pathway. We believe, however, that these safety issues are the result of the design of some CD47 targeted agents and are not inherent to the CD47 target itself. We believe that conclusions currently being drawn regarding CD47 as a pathway should be confined only to specific individual agents.

這些安全性問題和相關的臨床挑戰導致人們對 CD47 途徑的潛在臨床效用產生重大懷疑。然而，我們認為這些安全問題是一些 CD47 標靶藥物設計的結果，而不是 CD47 標靶本身所固有的。我們認為，目前得出的有關 CD47 作為途徑的結論應僅限於特定的個別藥物。

We designed 154 to not engage Fc gamma receptors in order to avoid the anemias and other cytopenias that have plagued other agents in the class. Earlier this year at ASCO, we shared clinical data from our Phase 1A dose escalation clinical trial in platinum-resistant ovarian cancer or PROC patients. That data demonstrated that 154 does not cause destructive anemia, and this observation remains true today.

我們設計的 154 不與 Fc γ 受體結合，以避免困擾該類其他藥物的貧血和其他血球減少症。今年早些時候，我們在 ASCO 上分享了針對鉑類抗藥性卵巢癌或 PROC 患者進行的 1A 期劑量遞增臨床試驗的臨床數據。這些數據顯示 154 不會引起破壞性貧血，這項觀察結果至今仍然正確。

We remain encouraged by the safety and tolerability profile of 154 to date. 154 also differentiates from all other CD47 inhibitors through its CD40 agonist domain. This attribute of 154 has already led to a differentiated pharmacodynamic profile and dose escalation studies and may contribute to improved response rates, accelerated kinetics of response and durability of responses in our (technical difficulty)

到目前為止，我們仍然對 154 的安全性和耐受性狀況感到鼓舞。 154 也透過其 CD40 激動劑結構域區別於所有其他 CD47 抑制劑。 154的這一屬性已經導致了差異化的藥效學特徵和劑量遞增研究，並可能有助於提高我們的（技術難度）反應率、加速反應動力學和反應持久性。

Dr. Lini Pandite, our Chief Medical Officer, will expand (technical difficulty) At a high level, our confidence is bolstered by the interim results of 154 in combination with pegylated liposomal doxorubicin, which we will call PLD in patients with PROC. As of October 31, 2023, we have observed an overall response rate of 27%, which if it holds, would exceed the PLD monotherapy benchmark response rate of 4% in the Pfizer sponsored JAVELIN Ovarian 200 trial.

我們的首席醫療官Lini Pandite 博士將在高水平上擴展（技術難度），154 與聚乙二醇化脂質體阿黴素聯合使用的中期結果增強了我們的信心，我們將其稱為PROC 患者的PLD。截至 2023 年 10 月 31 日，我們觀察到整體緩解率為 27%，如果這一數字保持不變，將超過輝瑞贊助的 JAVELIN Ovarian 200 試驗中 PLD 單藥治療基準緩解率 4%。

We will also highlight recent data from our Phase 1A/B clinical trial evaluating 154 both as monotherapy and in combination with azacitidine in patients with relapsed refractory higher-risk MDS and AML. We completed the dose escalation portion of this study in the second quarter of 2023. And these data will be presented at the upcoming ASH annual meeting in December.

我們還將重點介紹 1A/B 期臨床試驗的最新數據，該試驗評估了 154 項單藥療法以及與阿扎胞苷聯合治療復發難治性高風險 MDS 和 AML 患者的情況。我們於 2023 年第二季完成了這項研究的劑量遞增部分。這些數據將在即將於 12 月舉行的 ASH 年會上公佈。

We have initiated two different frontline dose expansion cohorts, where 154 is being combined with azacitidine in patients with previously untreated higher-risk MDS or TP53 mutant AML. We are very pleased with the momentum in this trial.

我們已經啟動了兩個不同的一線劑量擴展隊列，其中 154 種藥物與阿扎胞苷聯合用於治療先前未經治療的高風險 MDS 或 TP53 突變 AML 患者。我們對這次試驗的動能感到非常滿意。

And enrollment has proceeded very quickly, which we attribute to the high unmet need for these patients and our investigators' enthusiasm regarding the differentiated profile of 154. We look forward to sharing an interim update from the frontline dose expansion cohorts in conjunction with ASH next month.

入組進展非常快，我們將其歸因於這些患者的高度未滿足需求以及我們的研究人員對 154 的差異化特徵的熱情。我們期待下個月與 ASH 一起分享一線劑量擴展隊列的臨時更新。

With that, I will now turn the call over to Lini, who will dive into our clinical programs and provide an update on recent clinical data and activities.

現在，我將把電話轉給 Lini，她將深入研究我們的臨床項目，並提供最新臨床數據和活動的最新資訊。

Thanks, Taylor, and good morning, everyone. 2023 continues to be a year of focused operational execution. I'm grateful for the relentless efforts of our team, our participating investigators and most importantly, the patients themselves that have enabled this progress.

謝謝泰勒，大家早安。 2023 年仍然是集中營運執行的一年。我感謝我們的團隊、參與的研究人員以及最重要的是患者本身的不懈努力，使這項進展得以實現。

As Taylor outlined, I will first provide an update from our Phase 1B trial investigating 154 in combination with PLD in patients with platinum-resistant ovarian cancer and then provide some color on the data in last week's ASH abstract from our Phase 1A/B trial investigating 154 in combination with azacitidine in patients with AML and higher-risk MDS.

正如Taylor 所概述的，我將首先提供我們154 期1B 期試驗的最新情況，該試驗調查了154 例聯合PLD 治療鉑類抗藥性卵巢癌患者的情況，然後提供了上週ASH 摘要中來自我們1A/B 期試驗調查的數據的一些資訊。154 與阿扎胞苷聯合治療 AML 和高危險 MDS 患者。

Let's start with our ongoing Phase 1B combination clinical trial of 154 in patients with platinum-resistant ovarian cancer. As of the data cutoff date of October 31, 2023, 16 patients with platinum-resistant ovarian cancer have been enrolled into this study. These patients have a median of 1.5 prior lines of systemic therapy. 154 plus PLD had an acceptable safety profile, which was consistent with the safety profile of the individual agents.

讓我們從正在進行的 1B 期聯合臨床試驗開始，該試驗涉及 154 名鉑類抗藥性卵巢癌患者。截至2023年10月31日資料截止日，已有16名鉑類抗藥性卵巢癌患者納入本研究。這些患者之前接受過全身性治療的中位數為 1.5 次。 154 plus PLD 具有可接受的安全性，這與單一藥物的安全性一致。

So 154, the most common drug-related adverse event was infusion-related reaction, mostly Grade 1 or 2. As of the data cutoff date of October 31, 2023, 11 patients were evaluable for efficacy. We offset three partial responses. One confirmed partial response and two, unconfirmed partial responses. As of November 9, 2023, both patients with unconfirmed partial responses are still on study and have not reached the date of confirmatory response assessment.

因此154中，最常見的藥物相關不良事件是輸液相關反應，多為1級或2級。截至資料截止日期2023年10月31日，有11位患者可進行療效評估。我們抵消了三個部分響應。一項已確認的部分回應和兩項未經確認的部分回應。截至2023年11月9日，兩名未確認部分緩解的患者仍在研究中，尚未達到確認緩解評估日期。

Four patients had a best response of stable disease, and four patients had progressive disease. As of the data cutoff date of October 31, 2023, the disease characteristics of the patients enrolled in this trial are similar to the characteristics of the patients enrolled in the Pfizer sponsored JAVELIN Ovarian 200 trial, which is a recently published randomized trial that included a PLD controlled arm. In the JAVELIN trial, the overall response rate for patients treated with PLD monotherapy was 4%.

4 名患者的最佳反應是疾病穩定，4 名患者的疾病惡化。截至資料截止日期2023年10月31日，參與該試驗的患者的疾病特徵與參加輝瑞贊助的JAVELIN Ovarian 200試驗的患者的特徵相似，該試驗是最近發表的一項隨機試驗，其中包括PLD 控制臂。在 JAVELIN 試驗中，PLD 單藥治療患者的整體緩解率為 4%。

Additionally, to date, a higher proportion of patients enrolled in our trial have bulky disease measuring over 5 cm in diameter and pre-treatment with bevacizumab, both of which are poor prognostic factors. We expect to complete enrollment of the expansion cohorts this quarter and to provide additional response and response durability data from the full cohort by mid-year 2024.

此外，迄今為止，參加我們試驗的患者中有較高比例的患者患有直徑超過 5 公分的大塊疾病，並且接受過貝伐單抗治療，這兩者都是不良預後因素。我們預計將在本季度完成擴展隊列的註冊，並在 2024 年年中之前提供整個隊列的額外回應和回應持久性數據。

Overall, we are encouraged by the emerging data from this combination cohort and look forward to update with more patients and longer follow-up. We are also continuing enrollment in our Phase 1B trial of 154 in combination with mirvetuximab soravtansine in platinum-resistant ovarian cancer. Enrollment and dosing are progressing quickly. We expect to report initial combination data from this trial mid-year 2024.

總體而言，我們對這個組合隊列中的新數據感到鼓舞，並期待更多患者和更長的追蹤進行更新。我們也持續招募 154 名患者合併 mirvetuximab soravtansine 治療鉑類抗藥性卵巢癌的 1B 期試驗。入組和給藥工作進展迅速。我們預計將在 2024 年年中報告該試驗的初始組合數據。

Let us now turn to the progress we have made in our Phase 1A/B clinical trial in AML and higher-risk MDS. In this trial, we are evaluating the safety, tolerability pharmacokinetics, anti-tumor activity and pharmacodynamic effects of 154 as both monotherapy and in combination with azacitidine, the current standard of care.

現在讓我們來看看我們在 AML 和高風險 MDS 的 1A/B 期臨床試驗中取得的進展。在這項試驗中，我們正在評估 154 作為單一療法以及與目前標準治療阿扎胞苷聯合使用的安全性、耐受性藥物動力學、抗腫瘤活性和藥效學作用。

As described in our ASH abstract, 37 adult patients with primarily relapsed refractory AML or higher-risk MDS, have received 154 as monotherapy or in combination with azacitidine. These patients had a median of two prior lines of therapy. There are 19 patients in the monotherapy cohort and 18 patients in the combination cohort as of the data cutoff date of May 25, 2023.

如我們的 ASH 摘要中所述，37 名患有原發性復發難治性 AML 或高風險 MDS 的成年患者已接受 154 名單藥治療或與阿扎胞苷聯合治療。這些患者之前接受過兩次治療的中位數。截至資料截止日期2023年5月25日，單藥治療組有19名患者，聯合治療組有18名患者。

In this trial, 154 had an acceptable safety profile as a monotherapy and in combination. For 154, the most common drug-related adverse events was infusion-related reactions, mostly Grade 1 or 2. Monotherapy responses have not been reported with CD47 targeted agents in heavily pre-treated relapsed refractory AML patients.

在這項試驗中，154 名患者作為單一療法和聯合療法具有可接受的安全性。對於154 例患者，最常見的藥物相關不良事件是輸注相關反應，大多為1 級或2 級。在經過大量治療的複發性難治性AML 患者中，尚未報告CD47 標靶藥物的單藥治療反應。

Consequently, we were particularly encouraged by a monotherapy response in a heavily pre-treated relapsed refractory TP53 mutant AML patient. This patient had a rapid response to 154 monotherapy, achieved a morphologic leukemia-free state and was subsequently taken to allogeneic transplant and remains leukemia free.

因此，我們對經過大量預先治療的複發難治性 TP53 突變 AML 患者的單一療法反應感到特別鼓舞。該患者對 154 單藥治療有快速反應，達到形態學上無白血病狀態，隨後接受同種異體移植並維持無白血病狀態。

Additionally, in other patients, we also observed anti-leukemic activity in the form of blast count reductions. We also enrolled several previously untreated TP53 mutant higher-risk MDS patients in the dose escalation portion of our trial. These data included in the ASH abstract. As of the data cutoff date of July 10, 2023, anti-tumor activity was observed in combination with azacitidine in two of four response-evaluable patients with previously untreated TP53 mutant higher-risk MDS.

此外，在其他患者中，我們也觀察到原始細胞計數減少形式的抗白血病活性。我們也在試驗的劑量遞增部分招募了幾名先前未經治療的 TP53 突變高風險 MDS 患者。這些數據包含在 ASH 摘要中。截至 2023 年 7 月 10 日的數據截止日期，在 4 名既往未接受治療的 TP53 突變高風險 MDS 的可評估療效患者中，有 2 名患者觀察到聯合阿扎胞苷的抗腫瘤活性。

We observed one complete response in a treatment-related TP53 mutant higher-risk MDS patient who remains on study and one marrow complete response in a patient who has taken to bone marrow transplant. Two patients had best response of stable disease. One of whom was taken to transplant.

我們在一名仍在接受研究的治療相關 TP53 突變高風險 MDS 患者中觀察到一種完全緩解，在一名接受骨髓移植的患者中觀察到一種骨髓完全緩解。兩名患者的疾病穩定反應最好。其中一名被送往移植手術。

Overall, we are encouraged by the growing body of data that validates the unique mechanism of action of 154 and its therapeutic potential to address the unmet needs of patients with AML and higher-risk MDS. Our data continue to show evidence of CD40-driven pharmacodynamic activity, both in peripheral blood and bone marrow.

整體而言，越來越多的數據驗證了 154 的獨特作用機制及其解決 AML 和高風險 MDS 患者未滿足需求的治療潛力，令我們感到鼓舞。我們的數據繼續顯示週邊血液和骨髓中 CD40 驅動的藥效活性的證據。

We believe that CD40 activation and the resulting involvement of the adaptive immune system is important in the heme. indications and may provide significant improvement to CD47 blockade in terms of both improved response rates and durability of response.

我們相信 CD40 的活化以及由此產生的適應性免疫系統的參與對於血紅素非常重要。適應症，並可能在改善反應率和反應持久性方面顯著改善 CD47 阻斷。

We look forward to presenting the complete data of the dose escalation portion of the trial in relapse refractory patients at the ASH meeting. And sharing initial data from the frontline expansion cohorts during a company-sponsored event around the time of ASH next month.

我們期待在 ASH 會議上展示復發難治性患者試驗劑量遞增部分的完整數據。並在下個月 ASH 期間公司贊助的活動中分享來自第一線擴張群體的初步數據。

With that, I will now turn the call over to Mr. Neill to discuss our financial update. Andrew?

現在，我將把電話轉給尼爾先生，討論我們的財務最新情況。安德魯？

Thank you, Lini, and good morning, everyone. As Conor mentioned at the onset of the call, the full financial results for the third-quarter 2023 are available in our 10-Q and earnings press release filed premarket this morning. I would like to focus on a few key points from our disclosures.

謝謝你，莉妮，大家早安。正如康納在電話會議開始時所提到的，2023 年第三季的完整財務業績可在我們今天上午盤前提交的 10 季和收益新聞稿中找到。我想重點談談我們披露的幾個要點。

We continue to be well positioned financially. As of September 30, 2023, our cash and cash equivalents and investments were $101.1 million. In the third quarter of 2023, our research and development expenses were $24.2 million as compared to $18.9 million for the third quarter of 2022.

我們的財務狀況持續良好。截至 2023 年 9 月 30 日，我們的現金及現金等價物及投資為 1.011 億美元。 2023 年第三季度，我們的研發費用為 2,420 萬美元，而 2022 年第三季為 1,890 萬美元。

In the third quarter of 2023, our general and administrative expenses were $5.1 million as compared to $6.6 million for the third quarter of 2022. Our net loss for the third quarter of 2023 was $27.5 million or $0.65 per basic and diluted share, as compared to a net loss of $24.6 million or $0.58 per basic and diluted share for the third quarter of 2022.

2023 年第三季度，我們的一般和管理費用為510 萬美元，而2022 年第三季度為660 萬美元。2023 年第三季度的淨虧損為2750 萬美元，即每股基本和稀釋每股0.65美元，而2022 年第三季的淨虧損為2022 年第三季淨虧損 2,460 萬美元，即每股基本虧損和稀釋每股虧損 0.58 美元。

Based on our current operating and development plans, we reiterate our financial guidance. Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations through year-end 2024, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on our company's current operational plans and excludes any capital that may be received, proceeds from any business development transactions and/or additional costs associated with clinical development activities that may be undertaken.

根據我們目前的營運和發展計劃，我們重申我們的財務指導。 Shattuck 相信，除了 SL-172154 一期臨床試驗的結果外，其現金和現金等價物以及投資將足以為其營運提供資金到 2024 年底。本現金跑道指南是基於我們公司目前的營運計劃，不包括可能收到的任何資本、任何業務開發交易的收益和/或與可能進行的臨床開發活動相關的額外成本。

With that, I'll hand the call back to Dr. Schreiber for final comments. Taylor?

這樣，我會將電話轉回施賴伯博士以徵求最終意見。泰勒？

Thank you, Andrew. In the third quarter of 2023, we made excellent progress across the four different ongoing expansion cohorts in our PROC, AML and higher-risk MDS trials. We expect several additional milestones and clinical updates through the end of this year. For data updates, we expect to first present complete data from the dose escalation portion of our Phase 1A/B clinical trial of 154 in relapsed refractory AML and higher-risk MDS patients at the 65th ASH annual meeting.

謝謝你，安德魯。 2023 年第三季度，我們在 PROC、AML 和高風險 MDS 試驗中的四個不同的持續擴展隊列中取得了出色進展。我們預計到今年年底將出現幾個額外的里程碑和臨床更新。對於數據更新，我們預計將在第 65 屆 ASH 年會上首先展示 154 名復發難治性 AML 和高風險 MDS 患者的 1A/B 期臨床試驗的劑量遞增部分的完整數據。

We also plan to present initial data from the frontline TP53 mutant AML dose expansion cohort and the frontline higher-risk MDS dose expansion cohort combining 154 with azacitidine in the fourth quarter of this year during a company-sponsored event following ASH.

我們還計劃在今年第四季度 ASH 後公司贊助的活動中展示來自一線 TP53 突變 AML 劑量擴展隊列和結合 154 與阿扎胞苷的一線高風險 MDS 劑量擴展隊列的初步數據。

For clinical program milestones, we expect to complete enrollment in the frontline higher-risk MDS cohort in the fourth quarter of 2023. We also plan to complete enrollment of our Phase 1B dose expansion cohort of 154 in combination with PLD and PROC in the fourth quarter of this year.

對於臨床專案的里程碑，我們預計在 2023 年第四季度完成一線高風險 MDS 隊列的入組。我們還計劃在第四季度完成 154 例聯合 PLD 和 PROC 的 1B 期劑量擴展隊列的入組今年的。

Should the initial results gathered in our heme and solid tumor studies hold as the size and maturity of these cohorts increase, 154 would have first-to-market potential among CD47 agents and PROC, as well as both AML and higher-risk MDS.

如果我們的血紅素和實體瘤研究中收集的初步結果隨著這些隊列的規模和成熟度的增加而成立，那麼 154 將在 CD47 藥物和 PROC 以及 AML 和高風險 MDS 中具有首先上市的潛力。

These are all areas of significant unmet medical need with multiple opportunities for accelerated development and subsequent registration directed studies. Taken together, I believe the combination of our experienced team, transformational science and protein engineering, as well as financial resources, puts us in a strong position to move beyond our next set of milestones and into 2024.

這些都是重大未滿足醫療需求的領域，有許多加速開發和後續註冊導向研究的機會。總而言之，我相信我們經驗豐富的團隊、轉型科學和蛋白質工程以及財務資源的結合，使我們處於有利地位，能夠超越下一組里程碑並進入 2024 年。

Before we conclude today's call, I would once again like to thank our patients and their families, the entire Shattuck team, our investors and the many people who have been supportive along the way.

在結束今天的電話會議之前，我要再次感謝我們的患者及其家人、整個嘉德團隊、我們的投資者以及一路以來給予支持的許多人。

With that, we are happy to take questions. Operator?

因此，我們很樂意回答問題。操作員？

(Operator Instructions)

（操作員說明）

Jonathan Miller, Evercore ISI.

喬納森·米勒，Evercore ISI。

Thank you for taking the question, guys, and congrats on getting to some real clinical data here. I'd love to start on the PROC study and ask a little bit more detail about the baseline characteristics of these patients. Obviously, these are platinum resistant, but can you give a little bit more granularity on what other variety of agents these patients have seen in their prior lines of therapy?

謝謝你們提出這個問題，夥計們，祝賀你們在這裡獲得了一些真實的臨床數據。我很樂意開始 PROC 研究，並詢問有關這些患者的基線特徵的更多細節。顯然，這些藥物具有鉑耐藥性，但是您能否更詳細地說明這些患者在先前的治療中還使用過哪些其他藥物？

And then maybe a little bit more open ended, as we think about comping this program to other CD47 programs, which obviously have -- well, had not been gathering the excitement that they once did, what is your expectation for being able to demonstrate in these patients that are responding the impact of CD40 ligand side of the molecule on the efficacy that you're seeing?

然後可能會更開放一點，當我們考慮將此程序與其他 CD47 程序進行比較時，這些程序顯然沒有像以前那樣令人興奮，您對能夠在這些患者是否對分子的CD40 配體側對療效的影響做出了反應？

Great. Well, good morning, John. Thank you, and thanks for the questions. Lini, why don't you go ahead and answer John's first question around the baseline characteristics of these patients and how they compare to JAVELIN and then I'll follow you with the second part.

偉大的。嗯，早上好，約翰。謝謝你，也謝謝你的提問。 Lini，您為什麼不繼續回答 John 關於這些患者的基線特徵以及它們與 JAVELIN 的比較的第一個問題，然後我將繼續您的第二部分。

Thank you, Jon, for the question. Yes, these patients compare very well to the patients who were enrolled in the JAVELIN study. The majority of these patients, and that's 88% of these patients, had failed the frontline platinum-containing regimen and were resistant to frontline platinum.

謝謝喬恩提出的問題。是的，這些患者與 JAVELIN 研究的患者相比非常好。這些患者中的大多數（即 88%）未能接受一線含鉑治療方案，並對一線鉑類藥物產生抗藥性。

So 100% of these patients had received platinum, 56% of these patients had also received bevacizumab. These patients have also received PARP inhibitors. That number isn't in the slide deck, but patients have received PARP as well.

因此，100% 的患者接受了鉑類治療，其中 56% 的患者也接受了貝伐單抗治療。這些患者也接受了 PARP 抑制劑治療。這個數字不在幻燈片中，但患者也接受了 PARP。

Great. Thanks, Lini. And, pardon me, with regard to how 154 needs to show in these patients and how that compares to what's evolved in the AML and higher-risk MDS space with other CD47 inhibitors, as most of the audience probably knows, this has been an evolving space over the last three years and certain agents might have been discontinued in the AML and higher-risk MDS space early on purely for competitive reasons under the assumption that magrolimab would be first to market and therefore, the commercial opportunity might have dwindled.

偉大的。謝謝，莉妮。而且，請原諒我，關於154 需要如何在這些患者中顯示，以及與其他CD47 抑製劑在AML 和高風險MDS 領域的進展相比如何，正如大多數觀眾可能知道的那樣，這是一個不斷發展的在過程過去三年中，某些藥物可能純粹出於競爭原因而在 AML 和高風險 MDS 領域早期停產，假設 Magrolimab 將首先進入市場，因此商業機會可能會減少。

Clearly, that's changed, and we certainly look forward to Gilead sharing more data around exactly what happened with ENHANCE and ENHANCE-2 to as part of their new commitment to increase transparency. It seems, however, as though many of these patients enrolled to the magrolimab arms, may have discontinued earlier or may have had dose interruptions in a way that could have impacted the topline readouts of that study. And hopefully, we'll learn more about that.

顯然，情況已經改變，我們當然期待吉利德分享更多有關 ENHANCE 和 ENHANCE-2 所發生的數據，作為其提高透明度的新承諾的一部分。然而，似乎許多參加 Magrolimab 治療組的患者可能已經提前停藥，或者可能已經中斷劑量，這可能會影響研究的頂線讀數。希望我們能更多地了解這一點。

Regardless, 154 has to stand on its own two feet in syndication. And clearly, we're encouraged by the differentiated safety profile, the lack of destructive anemia. and in pre-clinical models, the activity of CD40 agonism translated to both improved response rates and improved response durability.

無論如何，154 必須在聯合組織中自立。顯然，我們對差異化的安全性和缺乏破壞性貧血感到鼓舞。在臨床前模型中，CD40 激動劑的活性轉化為反應率和反應持久性的增加。

And clearly in patients like this, improved CR rates, not just over the expectations of azacitidine alone, but over prior benchmarks with AZA plus, drugs like magrolimab are important to exceed.

顯然，在這樣的患者中，CR 率得到改善，不僅超過了單獨使用阿扎胞苷的預期，而且超過了 AZA plus 等藥物之前的基準，重要的是要超過這一點。

And if and only if you exceed those CR rates, do you then have an opportunity of seeing an improved duration of response and improved overall survival. And so that's what we'll be looking to see and certainly share the first glimpse of that in proximity to ASH in December. And in the higher-risk MDS population, we're looking to exceed the azacitidine benchmark in terms of complete response, which comes from the [Apria] study of about 22% by at least double.

當且僅當您超過這些 CR 率時，您才有機會看到緩解持續時間延長和整體存活率提高。因此，這就是我們將在 12 月看到的，並且肯定會在 ASH 附近首次看到的情況。在高風險 MDS 族群中，我們希望在完全緩解方面超過阿扎胞苷基準，該基準來自 [Apria] 研究，約 22%，至少兩倍。

And in terms of the TP53 mutant AML cohort, where azacitidine alone delivers complete response rates in the low single digits. And the combination of AZA-Magro, we'll get more data I hope soon, but seems to deliver CR rates in the low 30%s.

就 TP53 突變 AML 群而言，單獨使用阿札胞苷即可達到低個位數的完全緩解率。 AZA-Magro 的組合，我希望很快就能獲得更多數據，但 CR 率似乎在 30% 以下。

And again, we'll look to exceed that by a substantial margin. So these are things that we have to show on our own as the field, hopefully learns more about the other agents that have been discontinued.

再次，我們希望大幅超越這個目標。因此，這些是我們必須在現場展示的內容，希望能了解更多有關已停產的其他代理商的資訊。

Thank you.

謝謝。

Your next question comes from the line of Joe Pantginis of H.C. Wainwright. Your line is open and everybody.

您的下一個問題來自 H.C. 的 Joe Pantginis。溫賴特。你們的線路是開放的，大家都可以。

Joe Pantginis, H.C. Wainwright.

喬潘吉尼斯，H.C.溫賴特。

Hey, everybody. Good morning. Thanks for taking the question and nice to see the early data. So congrats as well. So maybe Taylor, wanted to see if we could get or do some scenario analysis here, maybe start with the AML/MDS study.

嘿，大家。早安.感謝您提出問題，很高興看到早期數據。所以也恭喜你。所以也許泰勒想看看我們是否可以在這裡進行一些場景分析，也許可以從 AML/MDS 研究開始。

What do you -- obviously the expansion cohorts need to read out, but could you envision a, say more targeted path for initial approval, say targeting TP53 or other focused mutation? And then also, can you provide any color with regard to the kinetics of the responses that you're starting to see in the AML/MDS study?

顯然，擴展隊列需要讀出什麼，但是您能否設想一條更有針對性的初步批准路徑，例如針對 TP53 或其他重點突變？另外，您能否提供有關您在 AML/MDS 研究中開始看到的反應動力學的任何顏色？

Sure, thanks for the question, Joe, and good morning. So as you know, one of the expansion cohorts is already specific to TP53 mutant AML patients where even in the frontline setting, there is a very high unmet medical need.

當然，謝謝你的提問，喬，早安。如您所知，其中一個擴充隊列已經專門針對 TP53 突變 AML 患者，即使在前線環境中，也存在非常高的未滿足醫療需求。

And there certainly would be an opportunity for an accelerated path there if we were to first hit the CR rate in excess of 40% or so. I think that would be interesting and be a good indicator of what that could translate into in terms of duration of response, where we'll be looking to exceed something in the six-, seven-month range as a benchmark.

如果我們先將 CR 率達到 40% 以上，那麼肯定有機會加速這一進程。我認為這會很有趣，並且可以很好地表明這可以轉化為回應持續時間，我們將尋求超過六到七個月範圍內的某個值作為基準。

And those are readouts that we expect to come in the first half of next year, having fully enrolled that TP53 mutant AML cohort during the third quarter and would be the basis for discussion with regulators about first, an incremental expansion of that study to confirm that data and subsequently, what the registration directed path could be there. But I do agree that there is a potential accelerated opportunity.

這些是我們預計在明年上半年發布的結果，我們已經在第三季度完全招募了 TP53 突變 AML 隊列，並將成為與監管機構討論的基礎，首先是逐步擴展該研究，以確認數據以及隨後的註冊定向路徑可能在那裡。但我確實同意存在潛在的加速機會。

In terms of the kinetics of response, I can comment on a couple of data points that we have and will certainly add to this soon. The -- first of all, the relapsed refractory AML patient that is disclosed in the ASH abstract as a monotherapy responder, as Lini outlined, this was a tough patient. They've failed 7+3, they've failed FLAG, they've failed VEN-AZA.

就反應動力學而言，我可以對我們擁有的幾個數據點進行評論，並且肯定會很快添加到這一點。首先，正如 Lini 所概述的那樣，ASH 摘要中披露的復發難治性 AML 患者是一位對單一療法有反應的患者，這是一位很難相處的患者。他們失敗了7+3，他們失敗了FLAG，他們失敗了VEN-AZA。

And then they came on to study and had a response within the first cycle of 154 monotherapy. That's unusual for a patient like this, but it's consistent with the kinetics of response that we had observed with the pre-clinical equivalent of 154 in various models.

然後他們開始研究，並在 154 單一療法的第一個週期內取得了反應。這對於這樣的患者來說是不尋常的，但它與我們在各種模型中觀察到的 154 臨床前等效物的反應動力學一致。

I can also say that the confirmed responder in PROC, that response started at the very first eight-week scan. And that's also the case with the two unconfirmed responders in PROC where that first eight-week scan, they met that PR criteria. So it appears that the kinetics of response to 154 are rapid. And that's helpful, especially when looking at initial data sets and trying to forecast how that might translate.

我還可以說，PROC 中確認的響應者，該響應是在第一次八週掃描時開始的。 PROC 中兩名未經確認的響應者的情況也是如此，他們在第一次八週掃描中符合 PR 標準。因此看來對 154 的反應動力學是很快的。這很有幫助，尤其是在查看初始資料集並嘗試預測其可能如何轉換時。

Great. Thanks, Taylor.

偉大的。謝謝，泰勒。

Thanks, Joe.

謝謝，喬。

Marc Frahm, TD Cowen.

馬克·弗拉姆，TD·考恩。

Hey, thanks for taking my questions. And congrats on the early response data today. Maybe you start it off with when -- can you just explain the gap from the 16 who have seen drug and the 11, how many of those five are still on trial awaiting the first scan versus you having maybe discontinued for other reasons?

嘿，謝謝你回答我的問題。祝賀今天的早期響應數據。也許你可以從什麼時候開始——你能解釋一下16 名吸毒者和11 名吸毒者之間的差距嗎？這5 名中有多少人仍在等待第一次掃描，而你可能因為其他原因已經停止了？

And then are you seeing any -- to the point of about half the patients who have had [PROC expansion] and half have not, I know it's small numbers, but any sense that maybe efficacy is in one of those populations more than the other?

然後你是否看到任何情況——大約一半的患者進行了[PROC擴展]，一半的患者沒有，我知道這個數字很小，但從任何意義上說，其中一個人群的療效可能比另一個人群更高？

Great. Morning, Marc. Thanks for the question. Lini, why don't you go ahead and take those. Lini, you might be on mute.

偉大的。早上好，馬克。謝謝你的提問。莉妮，你為什麼不去拿走那些？莉妮，你可能處於靜音狀態。

Sorry, Mark, can you repeat the first question? I lost the connection.

抱歉，馬克，你能重複第一個問題嗎？我失去了聯繫。

Oh sorry. Yes, the safety database has 16 patients in it today and 11 are efficacy evaluable. Can you just explain the kind of five patient cap there? How many of them are waiting for their first scan versus maybe discontinued for others?

哦對不起。是的，安全資料庫目前有 16 名患者，其中 11 名患者的療效可評估。您能解釋一下那裡的五名患者上限嗎？其中有多少人正在等待第一次掃描，而其他人可能已經停止掃描？

Yeah. All five are still on study. They have -- they are waiting for their first scan.

是的。這五人仍在學習中。他們正在等待第一次掃描。

Okay. And then of the responses you're seeing, any sense that maybe this efficacy is more or less in the PARP experienced versus non-PARP eligible type of patient?

好的。然後，從您看到的反應來看，有沒有感覺到這種功效在經歷過 PARP 的患者與不符合 PARP 資格的患者類型中或多或少有區別？

At the moment, Marc, it's too early to kind of draw those conclusions. The first patient had received PARP. The first patient with the PR had received PARP inhibitors. The second patient -- the second -- the next two patients have received Bev. So it's hard to draw any conclusions at this.

馬克，目前得出這些結論還為時過早。第一位患者接受了 PARP。第一個 PR 患者接受了 PARP 抑制劑治療。第二名患者——第二名——接下來的兩名患者接受了 Bev 治療。所以對此很難下任何結論。

Okay, makes sense. And then thinking forward to next year, when we'll see the initial MIRV combo data, there's a couple of different populations based on MIRV expression level -- sorry, fully expression levels. Can you frame how big of a data set you're expecting to be able to provide and the robustness you'll be able to look across those different expression levels?

好吧，有道理。然後展望明年，當我們看到最初的 MIRV 組合數據時，會發現有幾個基於 MIRV 表達水平的不同群體——抱歉，是完全表達水平。您能否確定您期望能夠提供多大的資料集以及您能夠在不同表達水平上查看的穩健性？

Yeah, we are expecting it to enroll up to 70 patients. That 70 patients will include high, medium and low. And we are working with ImmunoGen to benchmark what would be an interesting response rate and durability of response in each of those subgroups.

是的，我們預計將招募多達 70 名患者。這70名患者將包括高、中、低。我們正在與ImmunoGen 合作，對每個亞組中有趣的反應率和反應持久性進行基準測試。

Kaveri Pohlman, BTIG.

卡維裡·波爾曼，BTIG。

Hi. Thank you for taking my question. I'm Christian. I'm on for Kaveri. So you actually answered part of my question and it was just about (inaudible) combo trial. Wanted to know what would you guys consider a meaningful [LAR arm]? Are you guys has being close to determining that, considering that this is enrolling fully receptor alpha, medium and low expressers.

你好。感謝您回答我的問題。我是基督徒。我代表卡維裡。所以你實際上回答了我的部分問題，這只是關於（聽不清楚）組合試驗。想知道你們認為什麼是有意義的 [LAR 手臂]？考慮到這是完全招募受體α、中度和低度表達者，你們是否已接近確定這一點。

But beyond that, I notice that [like your] registrational trial required 100% of the patients who received prior bevacizumab. So going forward are there plans to also make this a requirement in that trial?

但除此之外，我注意到[像你們的]註冊試驗要求 100% 的患者接受過貝伐珠單抗治療。那麼今後是否有計劃在該試驗中將此作為一項要求？

Great. Morning, Christian. Thanks for the question. Lini, why don't you go ahead and take that question as well.

偉大的。早安，克里斯蒂安。謝謝你的提問。 Lini，為什麼不直接回答這個問題呢？

Thank you for the question. So the trial was designed with the exact eligibility criteria, SORAYA. So all patients were required to have received bevacizumab. And that's how the trial was written.

感謝你的提問。因此，該試驗的設計符合確切的資格標準，SORAYA。因此，所有患者都必須接受貝伐單抗治療。審判就是這樣寫的。

Got it. Thank you. And my next question, just on about PLD combo trial. Are you guys planning to use biomarker analysis to determine differences in responders and non-responders? And if so, are you planning to use this all these patients in the future?

知道了。謝謝。我的下一個問題是關於 PLD 組合試驗。你們是否計劃使用生物標記分析來確定響應者和非響應者的差異？如果是這樣，您打算將來使用所有這些患者嗎？

Yeah, thanks Christian. We are continuing to collect a variety of different biomarker data from these patients, some of which is similar to the data that was shared in our ASCO abstract earlier this year with regard to peripheral cytokine responses, margination of CD40 expressing cells, changes in the immuno phenotype of both peripheral cells as well as through evaluation of pre- and on-treatment biopsies from these patients.

是的，謝謝克里斯蒂安。我們正在繼續從這些患者那裡收集各種不同的生物標記數據，其中一些數據與我們今年早些時候在ASCO 摘要中分享的數據相似，涉及外周細胞因子反應、CD40 表達細胞的邊緣化、免疫細胞的變化。週邊細胞的表型以及透過評估這些患者治療前和治療中的活組織檢查。

And we hope certainly that that data may inform a patient selection strategy or responder, non-responder analysis at a subsequent date, but we'll report on that as the size of the data set increases toward the end of the study.

我們當然希望這些數據可以為患者選擇策略或隨後的有反應者、無反應者分析提供信息，但隨著研究結束時數據集規模的增加，我們將對此進行報告。

Got it. Thank you. That's helpful. Thanks for taking my question.

知道了。謝謝。這很有幫助。感謝您提出我的問題。

No problem.

沒問題。

(Operator Instructions)

（操作員說明）

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

Yeah, hi. Thanks for taking the question. On PROC, I was just wondering if you plan to look at or if you already have looked at any correlation between the platinum-free interval for these patients and the degree of response?

是的，嗨。感謝您提出問題。關於 PROC，我只是想知道您是否計劃研究或是否已經研究過這些患者的無鉑間隔與反應程度之間的相關性？

And then, on heme, with respect to the frontline studies in CP53 and higher-risk MDS, you have any reason to believe or biologic hypothesis that the 154 as a combo would be potentially more effective in one of these cohorts versus the other? Thank you.

然後，關於血紅素，關於 CP53 和高風險 MDS 的一線研究，您有任何理由相信或生物學假設，即 154 作為組合在其中一個隊列中可能比另一個隊列更有效？謝謝。

Sure. Yeah, good morning, Yigal. Thanks for the questions. As Lini mentioned, 88% of the patients enrolled to date in the PROC study progressed within the first six months of platinum. And so this is a fairly homogeneous poor prognosis group with rapid kinetics of disease.

當然。是的，早上好，伊格爾。感謝您的提問。正如 Lini 所提到的，迄今為止，參與 PROC 研究的患者中有 88% 在鉑類藥物治療的前六個月內出現了進展。因此，這是一個相當同質的不良預後組，具有快速的疾病動力學。

And we really -- we alluded to before, the size of the data set is not large enough where we can tried to distinguish between, that it would make a difference if the patient progressed on platinum within one to three versus three to six months, although we can say is that all of these patients were rapidly resistant to primary platinum.

我們確實 - 我們之前提到過，數據集的大小不夠大，我們無法區分，如果患者在鉑類藥物治療後一到三個月內與三到六個月內取得進展，將會產生影響，儘管我們可以說的是，所有這些患者都對主要鉑類藥物迅速產生抗藥性。

And then with regard to whether there's a difference in the subpopulations or TP53 mutant AML versus higher-risk MDS in conjunction with azacitidine, we're looking forward to sharing more data there soon with the frontline cohorts. And what I can say is that it's always been a little bit of a mystery why the TP53 mutant AML patients with some prior studies seem to do a bit better than the TP53 wild type patients because otherwise, those are quite similar diseases.

然後，關於亞群或 TP53 突變 AML 與高風險 MDS 聯合阿扎胞苷是否存在差異，我們期待盡快與第一線隊列分享更多數據。我能說的是，為什麼 TP53 突變型 AML 患者在之前的一些研究中似乎比 TP53 野生型患者表現得更好，這一直是一個謎，因為除此之外，這些都是非常相似的疾病。

And one of the hypotheses that's been out there in the literature is that the TP53 mutant patients seem to have a higher mutational burden. Perhaps there were more tumor infiltrating CD8 positive T cells, i.e., perhaps it was a more immunogenic tumor to start than on the TP53 wild type patients.

文獻中的假設之一是 TP53 突變患者似乎具有更高的突變負擔。也許有更多的腫瘤浸潤性 CD8 陽性 T 細胞，即，與 TP53 野生型患者相比，它可能是更具免疫原性的腫瘤。

And part of the value proposition of adding a CD40 agonist to a CD47 inhibitor was framed around the expectation that some of those characteristics might be normalized because of the immune activating potential of CD40. And so it's certainly something that we're looking at. And a priori, we can't necessarily say that that would indeed be the case. But we'll be sharing data soon and following that over the next six to nine months.

在 CD47 抑制劑中添加 CD40 激動劑的部分價值主張是圍繞著這樣的預期構建的：由於 CD40 的免疫活化潛力，其中一些特性可能會正常化。所以這肯定是我們正在關注的事情。從先驗來看，我們不一定能說情況確實如此。但我們將很快共享數據，並在接下來的六到九個月內進行共享。

Okay. Thank you.

好的。謝謝。

You're welcome.

不客氣。

Gil Blum, Needham & Company.

吉爾布魯姆，李約瑟公司。

Hey, good morning and thanks for taking our question. So maybe just to focus here on the ovarian cancer, what would you gauge as a go, no-go decision on PLD plus 154. And how relevant is PLD's base and PROC? I mean, you faced some enrollment challenges here, so I'd love your two cents here and have a follow up.

嘿，早上好，感謝您提出我們的問題。因此，也許只是為了在這裡關注卵巢癌，您會評估 PLD 加 154 的可行或不可行決策。PLD 的基礎和 PROC 的相關性如何？我的意思是，您在這裡遇到了一些註冊挑戰，所以我希望您能在這裡貢獻兩分錢並進行跟進。

Yes, good morning, Gil, and thanks for the question. I mean, I can tell you that when we first started this study, there were many investigators who only joined the study because of the LAR arm because, as is highlighted by the JAVELIN study, PLD doesn't help very much in these patients. And it's now -- it took us about as long to enroll the first five patients in the study as it has to now complete enrollment in the study.

是的，早上好，吉爾，謝謝你的提問。我的意思是，我可以告訴你，當我們第一次開始這項研究時，有許多研究人員只是因為LAR 組才加入這項研究，因為正如JAVELIN 研究所強調的那樣，PLD 對這些患者沒有多大幫助。現在，我們將前五名患者納入研究所需的時間與現在完成研究所需的時間一樣長。

And perceptions can be changed by data, right? And I think we're starting to see that 154 is adding something in both heme and solids and certainly -- and people always seem to shy away from the word, synergy, and we can't say that quite yet. But if these data hold, then that's what this will mean in the PLD. setting.

數據可以改變看法，對吧？我認為我們開始看到 154 在血紅素和固體中添加了一些東西，當然，人們似乎總是迴避協同作用這個詞，我們還不能這麼說。但如果這些數據成立，那麼這就是 PLD 中的意義。環境。

This is an all-comer population and a response rate in excess of 25% in an all-comer PROC setting, non-biomarker selected in and of itself could be meaningful and could be very meaningful if it is accompanied by a duration of response that exceeds five months. And so those are benchmarks that we will be looking toward as the data mature over the first half of next year.

這是一個所有人群體，並且在所有人 PROC 設置中響應率超過 25%，選擇的非生物標記本身可能是有意義的，並且如果伴隨著響應持續時間，則可能非常有意義超過五個月。因此，隨著明年上半年數據的成熟，我們將關注這些基準。

And similar to my comments on the TP53 mutant AML cohort, in terms of what the next step would be, we'd be looking at an incremental expansion of the current study, somewhere between adding 20 and 40 patients or so to confirm the results and to enroll those patients with our current momentum. And that would be the basis then of a regulatory decision discussion for the first registration direct study.

與我對 TP53 突變 AML 隊列的評論類似，就下一步而言，我們將考慮逐步擴大當前研究，增加 20 到 40 名左右的患者來確認結果並以我們目前的勢頭招募這些患者。這將成為首次註冊直接研究的監管決策討論的基礎。

Excellent. Very helpful. And my follow-on is can we get a sense of the behavior of the non-responding patients' stable disease is kind of a immuno-oncology a lot of times, you see there is prolonged stable diseases? Thank you.

出色的。很有幫助。我的後續問題是，我們能否了解無反應患者的穩定疾病的行為很多時候是一種免疫腫瘤學，你看到有長期穩定的疾病嗎？謝謝。

Sure. It's too early to say too much. As Lini alluded to, there were, out of the balance of eight patients, four had a best response of progressive disease and four a best response of stable disease of varying lengths of time.

當然。現在說太多還為時過早。正如 Lini 所提到的，在 8 名患者中，有 4 名對疾病進展有最佳反應，4 名對不同時間長度的穩定疾病有最佳反應。

And I think we need to wait and see the full dataset from the initial 20-patient cohort before we can make any assertions about whether those patients with stable disease had stable disease for longer than you would expect in a patient population like this.

我認為我們需要等待並查看最初 20 名患者隊列的完整數據集，然後才能對這些疾病穩定的患者疾病穩定的時間是否比您在這樣的患者群體中預期的時間要長做出任何斷言。

All right, excellent. Thanks for taking our questions.

好吧，太棒了。感謝您回答我們的問題。

Thanks, Gil.

謝謝，吉爾。

Thank you. This concludes the Q&A session of the call. At this time, I would like to turn the call back over to Taylor Schreiber, Chief Executive Officer of Shattuck Labs for closing remarks.

謝謝。電話問答環節到此結束。此時，我想將電話轉回給沙特克實驗室執行長泰勒‧施賴伯 (Taylor Schreiber) 致閉幕詞。

Thank you, operator, and thank you all for joining the Shattuck Labs third-quarter 2023 financial results and business update conference call. We appreciate your continued interest in Shattuck, and we look forward to updating you on our milestones later this year. Thank you.

謝謝運營商，也感謝大家參加沙特克實驗室 2023 年第三季財務業績和業務更新電話會議。我們感謝您對嘉德的持續關注，我們期待在今年稍後向您通報我們的里程碑的最新情況。謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect. Have a wonderful day.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。祝你有美好的一天。