Curis Inc (CRIS) 2023 Q3 法說會逐字稿

Good morning, and welcome to Curis' Third Quarter 2023 business update call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.

早上好，歡迎參加 Curis 2023 年第三季業務更新電話會議。 （操作員說明）請注意，該事件正在被記錄。我現在想將會議交給 Curis 財務長 Diantha Duvall。黛安莎，請繼續。

Thank you, and welcome to Curis' Third Quarter 2023 business update call. Before we begin, I'd like to encourage everyone to go to the Investors section of our website at www.Curis.com to find our third quarter 2023 business update, press release and related financial tables.

謝謝您，歡迎參加 Curis 2023 年第三季業務更新電話會議。在我們開始之前，我想鼓勵大家造訪我們網站 www.Curis.com 的投資者部分，尋找我們 2023 年第三季的業務更新、新聞稿和相關財務表格。

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，實際結果可能有重大差異。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 Jame Dentzer, President and Chief Executive Officer, and Jonathan Zung, our Chief Development Officer. We will also be available for a question and answer period at the end of our call.

與我一起參加今天電話會議的有總裁兼執行長 Jame Dentzer 和我們的首席開發長 J​​onathan 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 Jame.

我現在想把電話轉給詹姆斯。

Thank you, Diantha. Good morning, everyone, and welcome to Curis' Third Quarter Business Update Call. This quarter marked a key inflection point for the company and for patients as we were able to return our focus to clinical enrollment in our TakeAim Leukemia and TakeAim Lymphoma studies with the removal of the partial clinical hold.

謝謝你，黛安莎。大家早安，歡迎參加 Curis 第三季業務更新電話會議。本季標誌著公司和患者的關鍵轉折點，因為我們能夠將重點重新轉移到 TakeAim 白血病和 TakeAim 淋巴瘤研究的臨床入組上，並取消部分臨床擱置。

Later this morning, abstracts for the 65th ASH Annual Meeting will be unveiled and we are pleased to have several abstracts under consideration. At ASH, we expect to provide an update from our TakeAim Lymphoma study, including our first look at proof-of-concept data for patients with primary CNS Lymphoma, a rare form of extra nodal non-Hodgkin Lymphoma, for which there are limited treatment options.

今天上午晚些時候，第 65 屆 ASH 年會的摘要將公佈，我們很高興有幾份摘要正在考慮中。在ASH，我們希望提供TakeAim 淋巴瘤研究的最新信息，包括我們對原發性中樞神經系統淋巴瘤患者的首次概念驗證數據，這是一種罕見的結外非霍奇金淋巴瘤，其治療方法有限選項。

In the TakeAim Leukemia study, we have re-opened our clinical sites and are working with them to identify and enroll new patients. As a reminder, the TakeAim Leukemia study is a monotherapy study, targeting patients with relapsed or refractory AML with either a FLT3 or spliceosome mutation. Enrollment of new patients has begun, and we expect to have our first look at data from these patients in the first half of 2024.

在 TakeAim 白血病研究中，我們重新開放了臨床中心，並正在與他們合作識別和招募新患者。提醒一下，TakeAim 白血病研究是一項單一療法研究，針對患有 FLT3 或剪接體突變的複發性或難治性 AML 患者。新患者的招募工作已經開始，我們預計將在 2024 年上半年首次看到這些患者的數據。

Lastly, we are working with clinical sites and regulatory authorities on advancing a new triplet study of emavusertib in combination with azacitidine and venetoclax in AML. This study is intended to evaluate safety, as well as emavusertib's ability to enhance the effectiveness of azacitidine and venetoclax by studying AML patients who are responding to azacitidine and venetoclax treatments, but still have minimal residual disease or MRD.

最後，我們正在與臨床中心和監管機構合作，推進一項新的 emavusertib 聯合阿扎胞苷和維奈托克治療 AML 的三聯體研究。本研究旨在透過研究對阿扎胞苷和維奈托克治療有反應但仍有微小殘留疾病或MRD 的AML 患者來評估安全性以及emavusertib 增強阿扎胞苷和維奈托克有效性的能力。

Our hope is that with the addition of emavusertib to their treatment regimen, we can help these patients convert from MRD-positive status to MRD-negative. We expect to initiate this study in the fourth quarter and see initial data in the second half of next year.

我們希望，透過在治療方案中加入emavusertib，我們可以幫助這些患者從MRD陽性狀態轉變為MRD陰性狀態。我們預計在第四季度啟動這項研究，並在明年下半年看到初步數據。

In short, we're making great progress in advancing the potential of emavusertib as a monotherapy, as a doublet therapy, combining with ibrutinib and as a triplet therapy in combination with azacitidine and venetoclax. All of which should have data over the coming four quarters. We look forward to providing those updates.

簡而言之，我們在提升emavusertib作為單一療法、與依魯替尼聯合的雙重療法以及與阿扎胞苷和維奈托克聯合的三聯療法的潛力方面取得了巨大進展。所有這些都應該有未來四個季度的數據。我們期待提供這些更新。

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，以審查我們本季的財務表現。石竹。

Thank you, Jame. For the third quarter of 2023, Curis reported a net loss of $12.2 million or $2.13 per share. As compared to a net loss of $13.3 million or $2.83 per share for the same period in 2022. Curis reported a net loss of $35.7 million or $6.96 per share for the nine months ended September 30, 2023, as compared to a net loss of $45.3 million or $9.82 per share for the same period in 2022.

謝謝你，詹姆斯。 Curis 報告 2023 年第三季淨虧損 1,220 萬美元，即每股淨虧損 2.13 美元。相比之下，2022 年同期淨虧損為1330 萬美元，即每股2.83 美元。Curis 報告截至2023 年9 月30 日的九個月，淨虧損為3570 萬美元，即每股6.96 美元，而淨虧損為45.3 美元2022 年同期為 100 萬美元，即每股 9.82 美元。

Revenues for the third quarters of 2023 and 2022 were both $2.8 million. Revenues for both periods consist of royalty revenues from Genentech, Genentech and Roche's sales of Erivedge. Revenues for the nine months ended September 30, 2023 and 2022 were both $7.3 million.

2023 年及 2022 年第三季的營收均為 280 萬美元。兩個時期的收入均包括來自基因泰克、基因泰克和羅氏銷售 Erivedge 的特許權使用費收入。截至2023年9月30日及2022年9月30日的九個月收入均為730萬美元。

Research and development expenses were $10.4 million for the third quarter of 2023, as compared to $10.8 million for the same period in 2022. The decrease in research and development expenses for the quarter is primarily attributable to lower employee-related costs due to a reduction in headcount, partially offset by increased clinical costs.

2023 年第三季的研發費用為 1,040 萬美元，而 2022 年同期為 1,080 萬美元。該季度研發費用的減少主要歸因於員工相關成本的減少，這是由於人員數量，部分被臨床費用增加所抵消。

Research and development expenses were $29.5 million for the nine months ended September 30, 2023, as compared to $34.6 million for the same period in 2022.

截至2023年9月30日的九個月，研發費用為2,950萬美元，而2022年同期為3,460萬美元。

General and administrative expenses were $4.8 million for the third quarter of 2023, as compared to $4.6 million for the same period in 2022. The increase was primarily attributable to higher professional legal and consulting services costs. General and administrative expenses were $13.8 million for the nine months ended September 30, 2023, as compared to $15.3 million for the same period in 2022.

2023 年第三季的一般和管理費用為 480 萬美元，而 2022 年同期為 460 萬美元。這一增長主要歸因於專業法律和諮詢服務成本的增加。截至 2023 年 9 月 30 日的九個月，一般及行政費用為 1,380 萬美元，而 2022 年同期為 1,530 萬美元。

Other income, net was $0.2 million for the third quarter of 2023, as compared to other expense, net of $0.7 million for the same period in 2022. Other income and expense, net primarily consist of interest income, partially offset by non-cash expense related to the sale of future royalties. Other income, net was $0.4 million for the nine months ended September 30, 2023, compared to other expense, net of $2.5 million for the same period in 2022.

2023 年第三季其他淨收入為 20 萬美元，而 2022 年同期其他支出淨額為 70 萬美元。其他收入和支出淨額主要包括利息收入，部分被非現金支出抵銷與未來特許權使用費的出售有關。截至 2023 年 9 月 30 日的九個月，其他收入淨額為 40 萬美元，而 2022 年同期其他費用淨額為 250 萬美元。

As of September 30, 2023, Curis' cash, cash equivalents and investments totaled $68.5 million, and there were approximately 5.9 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 2025.

截至 2023 年 9 月 30 日，Curis 的現金、現金等價物和投資總額為 6,850 萬美元，已發行普通股約 590 萬股。我們繼續保持強勁的現金狀況，預計我們現有的現金、現金等價物和投資將使我們能夠維持計劃營運到 2025 年。

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

至此，我想開始提問。操作員？

Thank you. Ladies and gentlemen, we'll now begin the question and answer session. (Operator Instructions)

謝謝。女士們、先生們，我們現在開始問答環節。 （操作員說明）

Your first question comes from Yale Jen from Laidlaw & Company. Please go ahead.

您的第一個問題來自 Laidlaw & Company 的 Yale Jen。請繼續。

Good morning and thanks for taking the questions and congrats on the progress. Two questions here. The first question is that in terms of the ASH abstract, you intend to rucaparib and that the present to present, could you give a little bit color you mentioned there's more than one. So what's the general context of that? Then I have a follow-up.

早安，感謝您提出問題並祝賀取得的進展。這裡有兩個問題。第一個問題是，就 ASH 摘要而言，您打算介紹 rucaparib 和目前要展示的產品，您能否提供一點您提到的顏色，有不止一個。那麼這件事的一般背景是什麼呢？然後我有一個後續行動。

Yeah. So I thank you Yale, I appreciate that. So we're going to defer most of the comments about the ASH abstract until the abstracts go live. However, what I would say is that we've got Leukemia and Lymphoma ongoing, The Leukemia study really got started or restarted in July with the enrollment of new patients. So those data are really a 2024 story, not an ASH story. The Lymphoma is really going to be the new data that are coming at ASH.

是的。所以我感謝耶魯大學，我很感激。因此，我們將推遲對 ASH 摘要的大部分評論，直到摘要上線。然而，我想說的是，我們的白血病和淋巴瘤研究正在進行中，隨著新患者的入組，白血病研究在 7 月真正開始或重新啟動。所以這些數據其實是 2024 年的故事，而不是 ASH 的故事。淋巴瘤確實將成為 ASH 上的新數據。

And as we've talked about before, we have in the past, looked at monotherapy and combination therapy, we've established our dose and we've targeted the indication of primary CNS Lymphoma as the ideal place for us to go. The reason we selected primary CNS, was as you recall, first, it's an orphan indication within Lymphoma. So that means a relatively small number of patients would be needed on the regulatory path.

正如我們之前談到的，我們過去研究過單一療法和聯合療法，我們已經確定了我們的劑量，並且我們將原發性中樞神經系統淋巴瘤的適應症作為我們的理想選擇。我們選擇原發性中樞神經系統的原因是，首先，它是淋巴瘤中的孤兒適應症。因此，這意味著監管路徑上所需的患者數量相對較少。

Second, there's a very clear unmet need. There is an established benchmark for what ibrutinib looks like in monotherapy. In primary CNS Lymphoma, ibrutinib attained a 19% CR rate. And then third, it really is going to establish what I hope to be a nice opportunity for us to demonstrate, first, whether we can be an additive benefit, can we increase the CR rate by adding our drug to ibrutinib. But also can we get CRs in patients who have progressed on a BTK treatment, can they be resensitize, that has always been the hypothesis.

其次，有一個非常明顯的未被滿足的需求。依魯替尼在單一療法中的表現有一個既定的基準。在原發性中樞神經系統淋巴瘤中，依魯替尼達到了 19% 的 CR 率。第三，我希望這確實是一個很好的機會，讓我們證明，首先，我們是否可以透過將我們的藥物添加到依魯替尼來提高 CR 率。但我們是否可以在接受 BTK 治療後取得進展的患者中獲得 CR，他們是否可以重新敏感，這一直是一個假設。

For emavusertib and IRAK4 inhibition, this will be the first time we can see data to see whether or not that's possible. So that would be my expectation for reviewing the data at ASH. Leukemia's, the 2024 story, the ASH story is going to be Lymphoma.

對於 emavusertib 和 IRAK4 抑制，這將是我們第一次看到數據來看看這是否可能。這就是我對 ASH 數據審查的期望。白血病，2024 年的故事，ASH 的故事將是淋巴瘤。

Okay, great. That's helpful, and the second question here is that you have mentioned earlier that before that high risk and the development work depends on what you see, what's the sort of standard of care potentially could be established. So you were set up there for doing that. And then what's your current thoughts in terms of that aspect?

好的，太好了。這很有幫助，這裡的第二個問題是，您之前提到過，在高風險和開發工作取決於您所看到的情況之前，可能會建立什麼樣的護理標準。所以你被安排在那裡做這件事。那麼您目前在這方面有什麼想法呢？

Now, that's exactly right. So in by standard of care, as you know, the standard of care in AML is the azacitidine, venetoclax doublet. Today as we stand, the standard of care in MDS is azacitidine monotherapy, the azacitidine, venetoclax study is still pending, that's the Verona study, and those results presumably are imminent.

現在，這是完全正確的。因此，按照護理標準，如您所知，AML 的護理標準是阿扎胞苷和維奈托克雙藥。目前，MDS 的治療標準是阿札胞苷單一療法，阿札胞苷、維奈托克研究仍在進行中，即維羅納研究，這些結果可能即將到來。

So we are waiting to see of course, is if that study is positive or negative, if that study is positive and the doublet is also the standard of care in MDS will want to proceed with a triplet. If on the other hand, it's negative and azacitidine remains as monotherapy, the standard of care, then we would look to proceed with a doublet.

當然，我們正在等待，看看這項研究是積極的還是消極的，如果這項研究是積極的，並且雙聯體也是 MDS 的護理標準，我們將希望繼續進行三聯體。另一方面，如果結果為陰性，且阿札胞苷仍然作為單一療法（護理標準），那麼我們將考慮繼續進行雙重療法。

Is that helpful?

有幫助嗎？

(technical difficulty) Absolutely, that's -- they're very helpful. And maybe what any timeline, you can sort of a speculate at this point?

（技術難度）當然，他們非常有幫助。也許您現在可以推測什麼時間線？

We don't run that study, so unfortunately, no, I mean, I think what the broader world is expecting is that it's sometime over the next few months, whether that's ASH or sometime in early 2024. Of course, we don't know any more than you do, but we're eagerly awaiting the outcome of those data.

我們沒有進行這項研究，所以不幸的是，不，我的意思是，我認為更廣泛的世界所期待的是未來幾個月的某個時間，無論是ASH 還是2024 年初的某個時間。當然，我們不知道我們比你們知道的更多，但我們熱切地等待這些數據的結果。

Okay, great. That's very helpful. And again, congrats on the progress and look forward to speaking to that.

好的，太好了。這非常有幫助。再次恭喜所取得的進展，並期待對此進行討論。

Thank you very much, Yale.

非常感謝你，耶魯。

Your next question comes from Li Watsek from Cantor Fitzgerald. Lee, please go ahead.

您的下一個問題來自 Cantor Fitzgerald 的 Li Watsek。李，請繼續。

Hey, good morning. Thanks for taking our questions. Jame, maybe can you just frame expectations for us a little bit for the data update in the first half of next year, particular in AML and MDS, what the bar will be?

嗨，早安。感謝您回答我們的問題。 Jame，也許您能為我們設定一些對明年上半年資料更新的期望，特別是在 AML 和 MDS 方面，標準是什麼？

Yeah. So in AML and MDS it's going to be separate, right? So we are proceeding with monotherapy in patients in the relapse refractory setting for FLT3 and spliceosome patients and MDS as you've asked about, we're really awaiting news of the Verona study to make sure we understand the path forward.

是的。那麼在 AML 和 MDS 中，它將是分開的，對嗎？因此，正如您所詢問的，我們正在對復發難治性患者進行 FLT3 和剪接體患者以及 MDS 的單一療法，我們真的在等待維羅納研究的消息，以確保我們了解前進的道路。

In FLT3 and spliceosome, the benchmarks are pretty clear FLT3 CR rate with gilteritinib and gilteritinib, as you know, is the market leader for FLT3 inhibitors is 12%. So of course, we would look to improve on that. Their CR-CRH rate was 22.6%. And of course, we would want to improve on that. In spliceosome patients, it's not clear that there are any treatments capable of getting a CR rate. As far as I know, there's never been anything published. The only data in the literature addressing spliceosome patients is that they have the worst of the worst prognosis.

在 FLT3 和剪接體方面，基準非常明確，FLT3 CR 率與 gilteritinib 和 gilteritinib（如您所知，FLT3 抑制劑的市場領導者）的 CR 率為 12%。當然，我們會尋求改進。他們的 CR-CRH 率為 22.6%。當然，我們希望對此進行改進。對於剪接體患者，尚不清楚是否有任何治療方法可以獲得 CR 率。據我所知，還沒有發表過任何東西。文獻中關於剪接體患者的唯一數據是他們的預後最差。

So as you know, in relapsed refractory AML, the survival is unfortunately quite poor. Median survival in studies ranges from two to four months. And what we understand from the literature is that the lower end of that range is for the spliceosome patients. But as far as we know, nobody has ever demonstrated you can get a response.

如您所知，不幸的是，在復發難治性 AML 中，存活率非常低。研究中的中位存活期為兩到四個月。我們從文獻中了解到，此範圍的下限適用於剪接體患者。但據我們所知，沒有人證明你可以獲得回應。

So in FLT3, what we're looking to do is can we improve upon FLT3 inhibitors as a class, with our FLT3 IRAK4 targeting molecule [asserted]. And that would be beating a 12% CR rate or a 22.6% CR-CRH rate. And in spliceosome patients, that would be anything that would be greater than zero, that presumably something worth of 10 would be very exciting in that setting.

因此，在 FLT3 中，我們希望做的是，我們能否利用我們的 FLT3 IRAK4 標靶分子來改進 FLT3 抑制劑這一類藥物[斷言]。這將超過 12% 的 CR 率或 22.6% CR-CRH 率。在剪接體患者中，這將是任何大於零的值，在這種情況下，大概值 10 的值會非常令人興奮。

Is that's helpful.

這樣有幫助嗎？

Okay. Yes, and I have another question for the triplet. Do you think you need to do more dose work for the combination? And also do you anticipate any drug-drug interaction or a triplet regimen?

好的。是的，我還有一個問題想問三胞胎。您認為您需要為該組合做更多的劑量工作嗎？您是否預期會出現任何藥物間交互作用或三重療法？

Excellent question. So the answer to the second one is, do we expect any DDI drug-drug interaction?

很好的問題。因此，第二個問題的答案是，我們是否預期會出現 DDI 藥物間交互作用？

I'd say we don't expect it, based on the work we've done in the lab and the clinical work we've done to date, we don't see that there's an overlapping safety profile. That said, of course, that's why you run the studies to see whether or not that stays consistent. In terms of our expectation, could you remind me where you were headed with that first part of the question in the triplet?

我想說的是，我們並不期望如此，根據我們在實驗室所做的工作和迄今為止所做的臨床工作，我們沒有發現存在重疊的安全狀況。當然，這就是為什麼你要進行研究來看看這種情況是否保持一致。就我們的期望而言，您能否提醒我三聯體問題的第一部分的走向？

Do you need to do more dose work?

您需要做更多的劑量工作嗎？

Oh, that's right. So the answer to that is yes. I mean, our first foray into the triplet study, we're going to be evaluating both safety and efficacy. So we think we know the right dose. We certainly know the right dose for monotherapy. We think we have the right dose in combination with ibrutinib and venetoclax, but this will be the first time we've studied the triplet in the clinic of aza and ven and ema. So I think based on the results of those, one of the things we're going to want to see is can we determine the appropriate dosing regimen for assertive in that setting.

哦，是這樣。所以答案是肯定的。我的意思是，我們第一次涉足三聯體研究，我們將評估安全性和有效性。所以我們認為我們知道正確的劑量。我們當然知道單一療法的正確劑量。我們認為我們有正確的劑量與 ibrutinib 和 Venetoclax 聯合使用，但這將是我們第一次在臨床中研究 aza 和 ven 和 ema 的三聯體。因此，我認為根據這些結果，我們想要看到的一件事是我們能否確定在這種情況下自信的適當劑量方案。

Any other questions, Li?

李老師還有什麼問題嗎？

No, that's great. Thank you.

不，那太好了。謝謝。

Excellent, thank you.

非常好，謝謝。

Your next question comes from Dane Leone from Raymond James. Dane, please go ahead.

您的下一個問題來自 Raymond James 的 Dane Leone。丹恩，請繼續。

(technical difficulty)

（技術難度）

He disconnected from the line. Your next question comes from AJ Rashid from Columbia Eagle. A.J please go ahead.

他斷開了線路。您的下一個問題來自 Columbia Eagle 的 AJ Rashid。 A.J請繼續。

On the overland dispute --

關於陸上爭端—

That last one broke up. I'm sorry about that. Are there any other questions in the queue?

最後那個分手了對此我很抱歉。隊列中還有其他問題嗎？

Okay. It appears there are no further questions. So this concludes our question and answer session. I'd like to turn the conference back over to the Company's President and Chief Executive Officer, James Dentzer, for any closing remarks.

好的。看來沒有其他問題了。我們的問答環節到此結束。我想將會議轉回公司總裁兼執行長 James Dentzer 致閉幕詞。

Thank you, Colin, and thank you, everyone, for joining today's call. As always, thank you to the patients and families participating in our clinical trials to our team at Curis for their tireless commitment and to our partners at Origin and the NCI for their ongoing help and support. We look forward to updating you again soon. Colin?

謝謝科林，也謝謝大家參加今天的電話會議。一如既往，感謝參與我們臨床試驗的患者和家屬，感謝 Curis 團隊的不懈努力，感謝 Origin 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。科林？

Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your line.

謝謝。女士們、先生們，今天的電話會議到此結束。我們感謝您的參與，並請您斷開線路。