Curis Inc (CRIS) 2023 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning, and welcome to the Curis First Quarter 2023 Business Update Call. (Operator Instructions) Please note, this event is being recorded.

    早上好,歡迎參加 Curis 2023 年第一季度業務更新電話會議。 (操作員說明)請注意,正在記錄此事件。

  • I would now like to turn the conference over to Ms. Diantha Duvall, Curis Chief Financial Officer. Ms. Diantha, please go ahead.

    現在我想將會議交給 Curis 首席財務官 Diantha Duvall 女士。戴安莎女士,請繼續。

  • Diantha Duvall - CFO, Treasurer, Assistant Secretary, Principal Financial Officer & Principal Accounting Officer

    Diantha Duvall - CFO, Treasurer, Assistant Secretary, Principal Financial Officer & Principal Accounting Officer

  • Thank you, and welcome to the Curis First Quarter 2023 Business Update Call. Before we begin, I would like to encourage everyone to go to the Investors section of our website at www.curis.com to find our first quarter 2023 business update release and related financial tables.

    謝謝,歡迎參加 Curis 2023 年第一季度業務更新電話會議。在開始之前,我想鼓勵大家訪問我們網站 www.curis.com 的投資者部分,查找我們 2023 年第一季度業務更新發布和相關財務表格。

  • I would also like to remind everyone that during the call, we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. For additional details, please see our SEC filings.

    我還想提醒大家,在電話會議期間,我們將根據我們當前的期望和信念做出前瞻性聲明。這些陳述存在一定的風險和不確定性,實際結果可能存在重大差異。有關更多詳細信息,請參閱我們向 SEC 提交的文件。

  • Joining me on today's call are Jim Dentzer, President and Chief Executive Officer; Bob Martell, Chief Scientific Officer; and Jonathan Zung, our newly appointed Chief Development Officer. We will also be available for a question-and-answer period at the end of the call.

    與我一起參加今天電話會議的還有總裁兼首席執行官 Jim Dentzer;鮑勃·馬爹利,首席科學官;以及我們新任命的首席開發官 Jonathan Zung。我們還將在通話結束時提供問答時間。

  • I'd now like to turn the call over to Jim.

    我現在想把電話轉給吉姆。

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Thank you, Diantha. Good afternoon, everyone, and welcome to Curis' first quarter business update call. This past quarter, we made important progress with our lead clinical candidate, emavusertib. As we mentioned in our March update, we completed enrolling the additional patients requested by FDA ahead of schedule, which we believe is indicative of both the clear unmet need in leukemia and the excitement among the clinical community for this novel agent.

    謝謝你,黛安莎。大家下午好,歡迎參加 Curis 第一季度業務更新電話會議。上個季度,我們的主要臨床候選藥物 emavusertib 取得了重要進展。正如我們在 3 月份的更新中提到的,我們提前完成了 FDA 要求的額外患者的招募,我們認為這表明白血病方面明顯未滿足的需求以及臨床界對這種新型藥物的興奮。

  • We are collecting and analyzing data from these patients this quarter and expect to discuss these data with the FDA in the third quarter. We are optimistic that these data will be sufficient for the FDA to allow us to proceed with a recommended Phase II dose and move into the expansion phase of our TakeAim leukemia study.

    我們本季度正在收集和分析這些患者的數據,並預計在第三季度與 FDA 討論這些數據。我們樂觀地認為,這些數據將足以讓 FDA 允許我們繼續進行推薦的 II 期劑量,並進入 TakeAim 白血病研究的擴展階段。

  • We're also enrolling patients with primary central nervous system lymphoma, or PCNSL, and treating them with emavusertib in combination with the BTK inhibitor, ibrutinib, in our TakeAim lymphoma study. We believe emavusertib in combination with ibrutinib has the potential to be an important new therapy in PCNSL, which is an orphan population of patients with high unmet need.

    我們還在 TakeAim 淋巴瘤研究中招募原發性中樞神經系統淋巴瘤 (PCNSL) 患者,並使用 emavusertib 與 BTK 抑製劑依魯替尼 (ibrutinib) 聯合治療。我們相信emavusertib與ibrutinib聯合有潛力成為PCNSL的重要新療法,PCNSL是一個孤兒群體,其需求未得到滿足。

  • I'm also pleased to announce the expansion of the Curis executive team with the addition of Dr. Jonathan Zung as our Chief Development Officer. Dr. Zung strengthens our executive team as a well-respected industry leader with a wealth of drug development experience in both biotech and large pharma.

    我還很高興地宣布擴大 Curis 執行團隊,任命 Jonathan Zung 博士為我們的首席開發官。 Zung 博士加強了我們的管理團隊,使其成為備受尊敬的行業領導者,在生物技術和大型製藥公司擁有豐富的藥物開發經驗。

  • In short, the Curis team continues to make significant progress in establishing our lead clinical candidate, emavusertib, showing both clear single-agent activity and broad potential in combination therapy as a potential cornerstone treatment in hematological malignancies. And we look forward to sharing the results of our discussions with FDA in the quarter ahead.

    簡而言之,Curis 團隊在建立我們的主要臨床候選藥物 emavusertib 方面繼續取得重大進展,顯示出明顯的單藥活性和聯合治療的廣泛潛力,作為血液惡性腫瘤的潛在基石治療。我們期待在下一季度與 FDA 分享我們的討論結果。

  • With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?

    接下來,我會將電話轉回給 Diantha,以審查我們本季度的財務業績。黛安莎?

  • Diantha Duvall - CFO, Treasurer, Assistant Secretary, Principal Financial Officer & Principal Accounting Officer

    Diantha Duvall - CFO, Treasurer, Assistant Secretary, Principal Financial Officer & Principal Accounting Officer

  • Thank you, Jim. For the first quarter of 2023, Curis reported a net loss of $11.6 million or $0.12 per share as compared to a net loss of $16.1 million or $0.18 per share for the same period in 2022. Revenues for the first quarter of 2023 were $2.3 million as compared to $2.1 million for the same period in 2022.

    謝謝你,吉姆。 Curis 報告 2023 年第一季度淨虧損 1160 萬美元,即每股 0.12 美元,而 2022 年同期淨虧損 1610 萬美元,即每股 0.18 美元。2023 年第一季度的收入為 230 萬美元,相比之下,2022 年同期為 210 萬美元。

  • Research and development expenses were $9.1 million for the first quarter of 2023 as compared to $11.4 million for the same period in 2022. The decrease in research and development expenses for the quarter is primarily attributable to the timing of manufacturing costs and lower employee-related costs due to a reduction in headcount.

    2023 年第一季度的研發費用為 910 萬美元,而 2022 年同期為 1140 萬美元。該季度研發費用的減少主要歸因於製造成本的時機和員工相關成本的降低由於人員減少。

  • General and administrative expenses were $4.8 million for the first quarter of 2023 as compared to $5.7 million for the same period in 2022. The decrease in general and administrative expenses was driven primarily by lower employee-related costs due to a reduction in headcount.

    2023 年第一季度的一般和管理費用為 480 萬美元,而 2022 年同期為 570 萬美元。一般和管理費用的減少主要是由於員工人數減少導致與員工相關的成本降低。

  • For the first quarter of 2023, other income net was $0.1 million as compared to other expense net of $1 million for the same period in 2022. Other income expense net primarily consists of interest income, partially offset by expense related to future royalty payments.

    2023 年第一季度,其他收入淨額為 10 萬美元,而 2022 年同期其他支出淨額為 100 萬美元。其他收入支出淨額主要包括利息收入,部分被未來特許權使用費相關支出所抵消。

  • As of March 30, 2023, Curis' cash, cash equivalents and investments totaled $71.8 million and there were approximately 96.6 million shares of common stock outstanding. We continue to be in a strong cash position and expect that our existing cash, cash equivalents and investments should enable us to maintain our planned operations into '25.

    截至 2023 年 3 月 30 日,Curis 的現金、現金等價物和投資總額為 7180 萬美元,已發行普通股約為 9660 萬股。我們繼續保持強勁的現金狀況,並預計我們現有的現金、現金等價物和投資將使我們能夠將計劃的運營維持到 25 年。

  • With that, I'd like to turn the call -- open the call for questions. Operator?

    說到這裡,我想轉接電話——開始提問。操作員?

  • Operator

    Operator

  • (Operator Instructions) And our first question will come from Li Watsek with Cantor Fitzgerald.

    (操作員說明)我們的第一個問題將由 Li Watsek 和 Cantor Fitzgerald 提出。

  • Li Wang Watsek - Research Analyst

    Li Wang Watsek - Research Analyst

  • Jim, just curious, for the 9 additional patients that you enrolled in Q1, do you have a sense how the activity that you've seen so far compares to the higher dose, the 300 mg? And do you have plans to maybe share the data prior to your meeting with the FDA in Q3?

    Jim,只是好奇,對於您在第一季度招募的另外 9 名患者,您是否知道迄今為止您所看到的活動與更高劑量(300 毫克)相比如何?您是否計劃在第三季度與 FDA 會面之前共享數據?

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • So thank you very much for the question. So we're planning on having the discussion with FDA first and then we'll discuss the data more publicly later. Of course, that's the way the FDA would prefer it, and I think that's the best answer for us at this time. I think what we can tell you that we've said in the past is we answered all of the FDA's questions last year with one exception. And that was we've got 2 doses, 200 milligrams BID and 300 milligrams BID, both of which look safe, both of which have shown responses. And the open question with the FDA is, which is the better of those 2 doses?

    非常感謝你提出這個問題。因此,我們計劃首先與 FDA 進行討論,然後我們將更公開地討論這些數據。當然,這是 FDA 更喜歡的方式,我認為這對我們來說是目前最好的答案。我想我們可以告訴你的是,我們過去說過的是,我們去年回答了 FDA 的所有問題,只有一個例外。我們有 2 種劑量,200 毫克 BID 和 300 毫克 BID,這兩種劑量看起來都很安全,也都顯示出反應。 FDA 的懸而未決的問題是,這兩種劑量中哪一種更好?

  • So our view would be the data we had last year at this time seem to anticipate that both were good, both could lead to responses, both were safe. There seemed to be a slight preference for 300. We have since added more patients at 200 to have a more fulsome analysis between the 2. And my assumption is going to be that when we take these data to the FDA, they're going to look at the data set and come out where we are. And that is both doses are safe, both doses are effective. If there's a preference for 300, that means the data were completely consistent with what we've seen so far. If there's a preference for 200, that means the data at 200 look even better than they did last time. Either of those outcomes is good, and I look forward to walking you through what these data look like after we have the conversation with FDA. Pretty long answer to the question, hope that's helpful.

    因此,我們的觀點是,去年此時我們掌握的數據似乎預計兩者都很好,兩者都可能導致反應,兩者都是安全的。似乎對 300 名患者有輕微的偏好。此後我們在 200 名患者中添加了更多患者,以便在這 2 名患者之間進行更全面的分析。我的假設是,當我們將這些數據提交給 FDA 時,他們將查看數據集並得出我們的位置。也就是說,兩種劑量都是安全的,兩種劑量都是有效的。如果偏好 300,則意味著數據與我們迄今為止所看到的完全一致。如果偏好 200,則意味著 200 時的數據看起來比上次更好。這兩個結果都是好的,我期待在我們與 FDA 對話後向您介紹這些數據。問題的回答很長,希望對你有幫助。

  • Li Wang Watsek - Research Analyst

    Li Wang Watsek - Research Analyst

  • Okay. Maybe a follow-up -- yes, sure. Maybe a follow-up question. When do you think you might be able to communicate to the Street with respect to the clinical hold after the meeting in Q3? And I guess for this meeting, would you be able to discuss the registrational path with FDA as well?

    好的。也許會有後續行動——是的,當然。也許是一個後續問題。您認為您什麼時候可以就第三季度會議後的臨床擱置事宜與華爾街進行溝通?我想在這次會議上,您是否也能與 FDA 討論註冊路徑?

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Yes. I think our plan right now is that we hope to have this discussion with the FDA at the end of Q3. So of course, we would come out with the answer with that as soon as we have it, that we're moving forward. In terms of the next steps, I think we've been pretty clear. In AML, the design -- the precedent for the design is fairly straightforward. We look at IDH1, IDH2, FLT3, all of these studies, pivotal studies were done with a single-arm design with CR/CRh as a primary endpoint, duration of response and survival as secondary endpoints. And we would assume that going forward, the FDA is going to be consistent with their past practice and have a similar design.

    是的。我認為我們現在的計劃是希望在第三季度末與 FDA 進行討論。當然,一旦我們得到答案,我們就會立即給出答案,我們正在繼續前進。就下一步而言,我認為我們已經非常明確了。在 AML 中,設計——設計的先例相當簡單。我們關注 IDH1、IDH2、FLT3,所有這些研究,關鍵研究都是採用單臂設計完成的,以 CR/CRh 作為主要終點,反應持續時間和生存作為次要終點。我們假設,未來 FDA 將與他們過去的做法保持一致,並有類似的設計。

  • In MDS, it's a longer discussion. It's both a good and bad thing. The reason why it's a longer discussion is because there is no precedent for relapsed/refractory treatment of MDS, and that's precisely because there are no drugs approved. So the good news in that, of course, is that it's a wide open space. The more uncertain news is, of course, because it's a wide open space and because nothing is approved, it's going to take some dialogue with FDA. As with getting off clinical hold, I look forward to having those discussions with FDA. And of course, the minute we can, we will be very eager to discuss with you.

    在 MDS 中,這是一個更長的討論。這既是好事也是壞事。之所以討論時間較長,是因為治療復發/難治性MDS尚無先例,而這正是因為尚無藥物獲批。當然,好消息是這是一個廣闊的開放空間。當然,更不確定的消息是,因為這是一個廣闊的開放空間,而且由於沒有任何內容獲得批准,因此將與 FDA 進行一些對話。與結束臨床擱置一樣,我期待與 FDA 進行這些討論。當然,只要有可能,我們將非常渴望與您討論。

  • Operator

    Operator

  • (Operator Instructions) Our next question will come from Yale Jen with Laidlaw & Company.

    (操作員說明)我們的下一個問題將來自 Laidlaw & Company 的 Yale Jen。

  • I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

    I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

  • My first question is with the 9 patients you already enrolled, is there anything you can talk about the general characteristics of these patients?

    我的第一個問題是,對於您已經入組的9名患者,您能談談這些患者的一般特徵嗎?

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • So yes, we're going to withhold talking about baseline characteristics and anything else that we're seeing until after we've had the discussion with FDA. We're not going to try and front run the FDA discussions. But what we can say is that what you already know in this population, whether you're looking at relapsed/refractory AML or relapsed/refractory MDS, these patients all have a very poor prognosis. Median survival in the literature is anywhere from 2.3 to 6 months. It's just a very bleak prognosis. So it's fair to say that any patients that have come into the study so far and any patients we're likely to see between now and NDA submission, those are going to be patients that are unfortunately in pretty tough shape.

    所以,是的,在我們與 FDA 進行討論之前,我們不會談論基線特徵和我們看到的任何其他內容。我們不會嘗試搶先進行 FDA 的討論。但我們可以說的是,您已經知道,在這個人群中,無論是複發/難治性 AML 還是複發/難治性 MDS,這些患者的預後都很差。文獻中的中位生存期為 2.3 至 6 個月。這只是一個非常悲觀的預測。因此,可以公平地說,迄今為止參與研究的任何患者以及從現在到提交新藥申請期間我們可能會看到的任何患者,不幸的是,這些患者的狀況都非常糟糕。

  • I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

    I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

  • Understood. I appreciate that, and I respect that as well. You -- also, my follow-up question here is that you mentioned about PCNSL. And could you give us a little bit background how would you start this? And what was the rationale behind it and where things are at this moment and what to anticipate in 6 or 9 months?

    明白了。我很欣賞這一點,也尊重這一點。您——還有,我的後續問題是您提到了 PCNSL。您能給我們介紹一下您將如何開始這個項目的背景嗎?其背後的理由是什麼?目前的情況以及 6 或 9 個月後的預期是什麼?

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • So the rationale for going into primary CNS lymphoma, so I can start and then I'll ask Bob to join in. So in general, in lymphoma, you remember we're treating lymphoma in combination with ibrutinib. The logic there is B-cell lymphoma today is treated really to downregulate NF-kappaB activity. And NF-kappaB, in turn, is driven by 2 biologic pathways: the BCR pathway where BTK lives; and the toll-like receptor pathway where IRAK4 lives.

    這是進入原發性中樞神經系統淋巴瘤的基本原理,所以我可以開始,然後我會請鮑勃加入。所以總的來說,在淋巴瘤中,您記得我們正在與依魯替尼聯合治療淋巴瘤。今天 B 細胞淋巴瘤的邏輯實際上是通過下調 NF-κB 活性來治療的。 NF-kappaB 又由 2 條生物途徑驅動:BTK 存在的 BCR 途徑;以及 IRAK4 所在的 Toll 樣受體通路。

  • What we discovered in our early scientific work that was then corroborated in the lab and then of course later in the clinic, is that if you want to downregulate NF-kappaB activity in these patients, the best thing to do isn't to shut down one pathway or the other, it's to shut down both.

    我們在早期的科學研究中發現,如果你想下調這些患者的 NF-kappaB 活性,最好的辦法就是不要關閉,然後在實驗室中得到證實,當然後來在臨床中也得到了證實。一條路徑或另一條路徑,就是關閉兩條路徑。

  • So that's the logic behind going down lymphoma in general. And in primary CNS lymphoma in particular, this is a type of cancer where it's particularly sensitive to the toll-like receptor side as opposed to the BCR side. And it's an orphan drug indication so it should mean that we can get to an answer fairly quickly that hopefully works in our favor. And Bob, I don't know if you want to add any more color to that?

    這就是總體上降低淋巴瘤背後的邏輯。特別是在原發性中樞神經系統淋巴瘤中,這種癌症對 Toll 樣受體側(而不是 BCR 側)特別敏感。這是一種孤兒藥適應症,因此這應該意味著我們可以很快找到對我們有利的答案。鮑勃,我不知道你是否想為此添加更多色彩?

  • Robert E. Martell - Head of Research & Development

    Robert E. Martell - Head of Research & Development

  • Yes. No, I think that was a good explanation. The majority of patients who have primary CNS lymphoma have MYD88 mutations. And sort of just to expand on what Jim said, this is a key driver of IRAK4 and ultimately NF-kappaB activity. And so the disease, the PCNSL disease seems to be weighted more towards the TLR pathway in terms of what's driving the actual disease. Now we have some really interesting data, and there's some nice data published in the literature in particular with CNS lymphoma.

    是的。不,我認為這是一個很好的解釋。大多數原發性中樞神經系統淋巴瘤患者都有 MYD88 突變。稍微擴展一下 Jim 所說的,這是 IRAK4 以及最終 NF-kappaB 活動的關鍵驅動因素。因此,就實際疾病的驅動因素而言,PCNSL 疾病似乎更傾向於 TLR 通路。現在我們有一些非常有趣的數據,並且文獻中發表了一些很好的數據,特別是有關中樞神經系統淋巴瘤的數據。

  • For example, we know that in preclinical models, we get excellent exposure of emavusertib in these tumors and crossing the blood-brain barrier as well. So this is a nice feature of emavusertib, in fact, getting levels in these preclinical models that are at therapeutic ranges. That's been demonstrated not only for CNS lymphoma but actually just as an aside for melanoma as well. So we think that this is a great area where there's not a lot of other drugs approved or used. And we think it's a great opportunity for us to capture as a potential early indication.

    例如,我們知道,在臨床前模型中,我們在這些腫瘤中獲得了 emavusertib 的良好暴露,並且還可以穿過血腦屏障。因此,這是 emavusertib 的一個很好的功能,事實上,在這些臨床前模型中獲得治療範圍內的水平。這不僅適用於中樞神經系統淋巴瘤,實際上也適用於黑色素瘤。所以我們認為這是一個很好的領域,沒有很多其他藥物被批准或使用。我們認為這是一個很好的機會,可以將其作為潛在的早期跡象。

  • I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

    I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

  • And what type of expectation could be in terms of next 6 to 9 months, should that be something that occur after the FDA meetings and with a sort of happy ending?

    未來 6 到 9 個月的預期是什麼?這應該是 FDA 會議之後發生的事情並有一個圓滿的結局嗎?

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Yes. I think it's a little too premature to talk about the timing of when we're going to have those data just yet. I'd say at this point, we are in the phase of working with our sites to identify the patients, get them on drug and then we'll follow them. Just broadly, one of the reasons why most investors have been following leukemia more than they've been following lymphoma is the bad news for the patients is that the leukemia disease sets tend to be a much worse prognosis, the patients frankly don't survive very long; versus in lymphoma, their outcomes are a little bit better. So our view would be that, all things being equal, we're likely to have data sets in the leukemia side sooner than we'll have data sets in the lymphoma side. But we are moving fast and furious on both fronts simultaneously.

    是的。我認為現在談論我們何時獲得這些數據還為時過早。我想說,目前我們正處於與我們的網站合作的階段,以確定患者的身份,讓他們接受藥物治療,然後我們將跟踪他們。概括地說,大多數投資者關注白血病多於關注淋巴瘤的原因之一對患者來說是壞消息,因為白血病疾病的預後往往要差得多,坦率地說,患者無法生存很長;與淋巴瘤相比,它們的結果要好一些。因此,我們的觀點是,在所有條件相同的情況下,我們可能會比淋巴瘤方面的數據集更早獲得白血病方面的數據集。但我們同時在兩條戰線上快速而激烈地前進。

  • Robert E. Martell - Head of Research & Development

    Robert E. Martell - Head of Research & Development

  • I'll quickly add to -- I don't know if you remember our data that we presented. Last year, we had 1 patient who was resistant to ibrutinib who continued ibrutinib. This is a patient with primary CNS lymphoma. They continued ibrutinib and added emavusertib and quickly went into a complete response. So we're really excited about that. I think that's a nice proof of concept in patients.

    我將快速補充一下——我不知道您是否還記得我們提供的數據。去年,我們有 1 名對依魯替尼耐藥的患者繼續服用依魯替尼。這是一名原發性中樞神經系統淋巴瘤患者。他們繼續使用依魯替尼並添加 emavusertib,並很快進入完全緩解狀態。所以我們對此感到非常興奮。我認為這對患者來說是一個很好的概念證明。

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Yes, underscores the idea, as we said, that NF-kappaB is really driving the disease. And in turn, what's driving NF-kappaB in these patients appears to be MYD88 going through the toll-like receptor side, which means they should be more amenable to our drug being added in combination. And to Bob's point, that 1 patient was only 1 patient. But it's obviously very exciting that it's consistent with what you might expect.

    是的,正如我們所說,這強調了 NF-kappaB 確實是疾病的驅動因素。反過來,在這些患者中驅動 NF-kappaB 的似乎是 MYD88 通過 toll 樣受體一側,這意味著他們應該更容易接受我們聯合添加的藥物。對於鮑勃來說,1 名患者只是 1 名患者。但它與您的預期一致,這顯然非常令人興奮。

  • Robert E. Martell - Head of Research & Development

    Robert E. Martell - Head of Research & Development

  • And a nice proof of concept that we can overcome ibrutinib resistance.

    這是我們可以克服依魯替尼耐藥性的一個很好的概念證明。

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Exactly.

    確切地。

  • I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

    I-Eh Jen - MD of Healthcare Research & Senior Biotechnology Analyst

  • Okay. Great. That's very encouraging. And again, best luck for the meetings with the agency.

    好的。偉大的。這非常令人鼓舞。再次祝愿與該機構的會議順利。

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Thank you, Yale.

    謝謝你,耶魯。

  • Operator

    Operator

  • The next question will come from Dane Leone with Raymond James.

    下一個問題將由戴恩·萊昂內和雷蒙德·詹姆斯提出。

  • Unidentified Analyst

    Unidentified Analyst

  • This is [Laura] on for Dane. I have 2 questions. First, how long is the follow-up duration for the 200-milligram expansion cohort package we've taken to the FDA? And then also, looking back at the venetoclax combination that you guys disclosed at ASH last year, are we going to be seeing any follow-up data or more robust patient characteristics at any point this year?

    這是戴恩的[勞拉]。我有 2 個問題。首先,我們向 FDA 提交的 200 毫克擴展隊列方案的隨訪時間是多長?然後,回顧一下你們去年在 ASH 上披露的維奈托克組合,今年我們是否會在任何時候看到任何後續數據或更穩健的患者特徵?

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Sure. So let me address the first question first. So in terms of the follow-up time, I think you can glean that from the guidance that we gave on timing. So we opened the sites up in Q4. We recruited the patients in Q1. We're following them and getting the data back in Q2, and then we're filing and discussing data with FDA in Q3. So that's sort of the time line really in a nutshell.

    當然。那麼讓我先解決第一個問題。因此,就後續時間而言,我認為您可以從我們給出的時間指導中了解到這一點。所以我們在第四季度開放了這些網站。我們在第一季度招募了患者。我們正在跟踪他們並在第二季度獲取數據,然後我們在第三季度向 FDA 提交數據並討論數據。簡而言之,這就是時間線。

  • On venetoclax, you may remember that when we were put on partial hold, the FDA asked us to enroll only the monotherapy at 200 milligrams. So we don't really have further information to talk about in those combination patients. Although, of course, as you can imagine, as we look forward to lifting of the partial hold, we look forward to moving forward not just with monotherapy but with the combination therapy path and look forward to having those discussions with you as soon as we can.

    關於 Venetoclax,您可能還記得,當我們被部分擱置時,FDA 要求我們只接受 200 毫克的單一療法。因此,對於這些合併患者,我們確實沒有更多信息可討論。當然,正如您可以想像的那樣,當我們期待解除部分保留時,我們不僅期待著單一療法,而且也期待著聯合治療路徑的發展,並期待一旦我們能夠與您進行這些討論能。

  • Robert E. Martell - Head of Research & Development

    Robert E. Martell - Head of Research & Development

  • Yes, and maybe I can add to that, one of the exciting things about venetoclax, it's -- as you recall the data, it looked like there was some really nice anticancer activity there. One of the key ways that leukemia has developed resistance to venetoclax is actually upregulation of other anti-apoptotic factors such as MCL-1, Bcl-xL. And these have been shown to be regulated through this exact pathway. And that's why we think this drug, emavusertib, may be able to overcome resistance of venetoclax as well.

    是的,也許我可以補充一點,關於維奈托克的令人興奮的事情之一是——正如你回想的數據,它看起來有一些非常好的抗癌活性。白血病對 Venetoclax 產生耐藥性的關鍵途徑之一實際上是其他抗凋亡因子(例如 MCL-1、Bcl-xL)的上調。這些已被證明是通過這條確切的途徑進行調節的。這就是為什麼我們認為這種藥物 emavusertib 也可能能夠克服 Venetoclax 的耐藥性。

  • Operator

    Operator

  • This concludes our question-and-answer session. I would like to turn the conference back over to the company's President and Chief Executive Officer, Mr. James Dentzer, for closing remarks. Please go ahead.

    我們的問答環節到此結束。我想將會議轉回公司總裁兼首席執行官 James Dentzer 先生致閉幕詞。請繼續。

  • James E. Dentzer - President, CEO & Director

    James E. Dentzer - President, CEO & Director

  • Thank you. And as always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment and to our partners at Aurigene, ImmuNext and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator?

    謝謝。一如既往,感謝參與我們臨床試驗的患者和家屬,感謝 Curis 團隊的辛勤工作和承諾,感謝 Aurigene、ImmuNext 和 NCI 的合作夥伴持續提供的幫助和支持。我們期待盡快再次為您提供最新消息。操作員?

  • Operator

    Operator

  • The conference has now concluded. Thank you again for your participation. You may now disconnect.

    會議現已結束。再次感謝您的參與。您現在可以斷開連接。