Syros Pharmaceuticals Inc (SYRS) 2024 Q3 法說會逐字稿

Good morning, and welcome to the Syros Pharmaceuticals third quarter 2024 financial results conference call. (Operator Instructions) Note that this call is being webcast live on the Investors and Media section of Syros' website at www.syros.com. Please be advised that today's call is being recorded.

早安，歡迎參加 Syros Pharmaceuticals 2024 年第三季財務業績電話會議。（操作員說明）請注意，本次電話會議正在 Syros 網站 www.syros.com 的投資者和媒體部分進行網路直播。請注意，今天的通話正在錄音。

At this time, I would like to turn the call over to Karen Hunady, Director of Investor Relations and Corporate Communications at Syros. Please go ahead.

現在，我想將電話轉給 Syros 投資者關係和企業傳播總監 Karen Hunady。請繼續。

Thank you. This morning, we issued a press release announcing our third quarter 2024 financial results. The full release is available on the Investors & Media section of Syros' website at www.syros.com. We will begin the call with prepared remarks by Conley Chee, our Chief Executive Officer; Dr. David Roth, our Chief Medical Officer; and Jason Haas, our Chief Financial Officer.

謝謝。今天上午，我們發布新聞稿，宣布 2024 年第三季財務業績。完整版本可在 Syros 網站 www.syros.com 的投資者與媒體部分取得。我們將以我們的執行長 Conley Chee 準備好的演講開始電話會議； David Roth 博士，我們的首席醫療官；以及我們的財務長 Jason Haas。

We will then open the call for questions. Kristin Stephens, our Chief Development Officer, is also here on the call with us today and will be available for Q&A.

然後我們將開始提問。我們的首席開發官 Kristin Stephens 今天也參加了我們的電話會議，並將接受問答。

Before we begin, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors including those set forth in the Risk Factors section of our quarterly report on Form 10-Q that we filed this morning, our annual report on Form 10-K that we filed earlier in the year and any other filings that we may make with the SEC in the future.

在開始之前，我想提醒大家，我們在本次電話會議上發表的聲明將包括前瞻性聲明。由於各種風險、不確定性和其他因素（包括我們提交的表格10-Q 季度報告的風險因素部分中列出的因素），實際事件或結果可能與任何前瞻性陳述中明示或暗示的事件或結果存在重大差異今天早上，我們發布了今年早些時候提交的 10-K 表格年度報告以及我們將來可能向 SEC 提交的任何其他文件。

Any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements.

任何前瞻性陳述僅代表我們截至今天的觀點，不應被視為代表我們在任何後續日期的觀點。我們特別聲明不承擔更新或修改任何前瞻性陳述的義務。

With that, I'd now like to turn the call over to Conley Chee. Conley?

現在，我想將電話轉給 Conley Chee。康利？

Thank you, Karen. Good morning, everyone, and thank you for joining us. Throughout the third quarter and in recent weeks, we continue to advance our mission to develop and deliver tamibarotene as a new standard of care for the frontline treatment of newly diagnosed higher-risk MDS patients with RARA gene overexpression, which we believe represents approximately 50% of the higher-risk population.

謝謝你，凱倫。大家早安，感謝您加入我們。在整個第三季度和最近幾週，我們繼續推進我們的使命，開發和提供他米巴羅汀，作為新診斷的RARA 基因過度表達的高危險MDS 患者一線治療的新標準治療，我們認為此類患者約佔50%屬於高危險群。

These are exciting times at Syros as we are nearing the pivotal data readout from our ongoing SELECT-MDS-1 Phase III trial in mid-November. This is a significant milestone in our work and one we expect will be transformative for our company.

這是 Syros 激動人心的時刻，因為我們即將在 11 月中旬正在進行的 SELECT-MDS-1 III 期試驗中讀出關鍵數據。這是我們工作中的一個重要里程碑，我們預計這將為我們公司帶來改變。

As you know, there remains a tremendous unmet need for higher-risk MDS patients, whose disease is often progressive and associated with a poor prognosis. There are very few frontline therapies in late-stage development and no new treatments beyond hypomethylating agents have been approved in over a decade. The current standard of care, azacitidine is an HMA that has only demonstrated a 17% complete response rate, leaving significant unmet need.

如您所知，對於高風險 MDS 患者的需求仍然存在巨大的未滿足的需求，這些患者的疾病往往呈進展性且預後不良。處於後期開發階段的一線療法非常少，十多年來除了低甲基化藥物之外還沒有新的療法獲得批准。目前的護理標準阿札胞苷是一種 HMA，僅表現出 17% 的完全緩解率，嚴重未滿足需求。

Patients and physicians are seeking new treatment options that can enhance clinical outcomes without compromising safety and tolerability. We believe tamibarotene has the potential to alter the current treatment paradigm and provide patients with a well-tolerated and convenient therapeutic option that can induce durable response and a better disease control.

患者和醫生正在尋求新的治療方案，以在不影響安全性和耐受性的情況下增強臨床結果。我們相信他米巴羅汀有潛力改變當前的治療模式，並為患者提供一種耐受性良好且方便的治療選擇，可以誘導持久的反應和更好的疾病控制。

With approximately 9,000 higher-risk MDS patients diagnosed in the US each year, we believe there is a significant commercial opportunity for tamibarotene. By 2029, the total market opportunity for higher-risk MDS therapeutics in the US will be approximately $1.6 billion. And the market opportunity for tamibarotene in the US for patients with RARA overexpression will be over $800 million.

美國每年診斷出約 9,000 名高風險 MDS 患者，我們相信他米巴羅汀存在巨大的商業機會。到 2029 年，美國高風險 MDS 治療的總市場機會將約為 16 億美元。在美國，他米巴羅汀治療 RARA 過度表現患者的市場機會將超過 8 億美元。

As we approach our pivotal data, we are working diligently to prepare for our first NDA filing and to launch tamibarotene in the US through our own commercial efforts. Once approved, our goal is to move quickly to deliver tamibarotene to the thousands of higher-risk MDS patients with RARA overexpression awaiting better treatment options. We are really looking forward to announcing our data in the coming weeks.

當我們接近關鍵數據時，我們正在努力準備我們的第一份 NDA 申請，並透過我們自己的商業努力在美國推出他米巴羅汀。一旦獲得批准，我們的目標是迅速採取行動，向數千名 RARA 過度表達的高風險 MDS 患者提供他米巴羅汀，等待更好的治療選擇。我們非常期待在未來幾週內公佈我們的數據。

With that, I'll turn it over to David to review our MDS program and upcoming milestones in greater detail. David?

接下來，我會將其交給 David，以更詳細地審查我們的 MDS 計劃和即將到來的里程碑。大衛？

Thank you, Conley. We are encouraged by the progress we've made in advancing tamibarotene, our oral selective RAR-alpha agonist as a potential new standard of care for higher-risk MDS patients with RARA overexpression, and look forward to the upcoming data from the SELECT-MDS-1 trial. As a reminder, SELECT-MDS-1 is a global, randomized, double-blind, placebo-controlled trial evaluating the combination of tamibarotene and azacitidine compared to placebo and azacitidine.

謝謝你，康利。我們對推進他米巴羅汀（我們的口服選擇性RAR-α 激動劑）作為RARA 過度表達的高風險MDS 患者的潛在新護理標準方面取得的進展感到鼓舞，並期待來自SELECT-MDS 的即將發布的數據-1 試用。提醒一下，SELECT-MDS-1 是一項全球、隨機、雙盲、安慰劑對照試驗，評估他米巴羅汀和阿扎胞苷的組合與安慰劑和阿扎胞苷的比較。

The trial's primary efficacy endpoint is complete response or CR, based on the analysis of the initial 190 enrolled patients, which, together with supporting durability data, can potentially serve as the basis for accelerated approval or full approval in the US. The trial will continue to enroll up to 550 patients for the key secondary endpoint of overall survival, and we are happy to report that global enrollment had over 130 sites continues to go very well.

該試驗的主要療效終點是完全緩解或 CR，基於對最初 190 名入組患者的分析，再加上支持的耐久性數據，有可能成為在美國加速批准或完全批准的基礎。該試驗將繼續招募多達 550 名患者，以實現整體生存的關鍵次要終點，我們很高興地報告，全球 130 多個地點的招募工作繼續進展順利。

The primary endpoint of CR is an important and clinically meaningful efficacy endpoint due to its correlation with overall survival as well as improvements in peripheral blood counts. Taken together, the clinical benefits associated with achieving a CR are compelling, and reinforce our confidence in the potential of our SELECT-MDS-1 trial, if successful, to address significant unmet need.

CR 的主要終點是一個重要且具有臨床意義的療效終點，因為它與總生存期以及週邊血液計數的改善有關。總而言之，與實現 CR 相關的臨床益處是引人注目的，並且增強了我們對 SELECT-MDS-1 試驗如果成功的話，解決重大未滿足需求的潛力的信心。

The SELECT-MDS-1 trial passed a prespecified futility analysis in the first quarter of 2024 based on the primary endpoint. These data along with a favorable tolerability profile observed in previous trials support our conviction in using the doublet strategy of tamibarotene plus azacitidine in higher-risk MDS. We're excited for these patients who have waited years for new therapeutic advancements for their condition.

SELECT-MDS-1 試驗於 2024 年第一季通過了基於主要終點的預設無效分析。這些數據以及先前試驗中觀察到的良好耐受性支持了我們在高風險 MDS 中使用他米巴羅汀加阿扎胞苷雙重策略的信念。我們為這些多年來等待新的治療進展的患者感到興奮。

We are often asked by investors how should we interpret the results that you're planning to share with us in mid-November? Or what kind of outcome are you hoping for? We believe that a successful pivotal trial result is not only one that hits its primary endpoint, but one that offers a generally well-tolerated safety profile. A positive trial would excite the medical community and will be met with enthusiasm by prescribers.

投資人經常問我們應該如何解讀您計劃在 11 月中旬與我們分享的結果？或者說你希望得到什麼樣的結果？我們相信，成功的關鍵試驗結果不僅是達到其主要終點，而且還提供了普遍耐受性良好的安全性。積極的試驗將令醫學界興奮，並受到處方醫生的熱情歡迎。

In particular, no new treatments in frontline higher-risk MDS beyond HMAs have been approved in over a decade. In our recent medical expert event held in June and in additional conversations we've had with physicians, it was emphasized that a successful trial result that achieves our primary endpoint would be clinically meaningful and likely drive strong usage.

特別是，十多年來，除了 HMA 之外，還沒有任何新的一線高風險 MDS 治療方法獲得批准。在我們最近於 6 月舉行的醫學專家活動以及我們與醫生進行的其他對話中，我們強調，達到我們主要終點的成功試驗結果將具有臨床意義，並可能推動廣泛使用。

They highlighted the challenges with existing therapies due to limited efficacy, the need for well-tolerated therapies that can be given over long periods of time and the exciting prospect for a first ever targeted agent for use in this population. Based on these considerations, we believe tamibarotene could rapidly become a standard of care. As you can imagine, we are very excited to report these pivotal data in November as they are expected to move us one step closer to bringing this potentially transformative drug to patients.

他們強調了現有療法由於療效有限而面臨的挑戰，需要可以長期給予耐受性良好的療法，以及第一個用於該人群的標靶藥物的令人興奮的前景。基於這些考慮，我們相信他米巴羅汀可能會迅速成為一種標準治療方法。正如您可以想像的那樣，我們非常高興能夠在 11 月報告這些關鍵數據，因為它們有望讓我們更進一步地將這種潛在的變革性藥物帶給患者。

I would now like to turn the call over to Jason, our Chief Financial Officer, to review our third quarter financial results. Jason?

我現在想將電話轉給我們的財務長傑森，以審查我們第三季的財務業績。傑森？

Thank you, David. Now turning to our third quarter financial results. We didn't recognize any revenue in the third quarter of 2024, as compared to recognizing revenue of $3.8 million in the third quarter of 2023. The decrease reflects last year's termination of Syros' collaboration agreement with Pfizer. R&D expenses were $20.5 million in the third quarter of 2024, as compared to $28.3 million in the third quarter of 2023.

謝謝你，大衛。現在轉向我們第三季的財務業績。與 2023 年第三季確認的收入 380 萬美元相比，我們在 2024 年第三季沒有確認任何收入。這一下降反映了去年 Syros 與輝瑞合作協議的終止。2024 年第三季的研發費用為 2,050 萬美元，而 2023 年第三季的研發費用為 2,830 萬美元。

The decrease was primarily due to the reduction in external R&D consulting, contract manufacturing and a reduction in head count and related expenses. Our R&D expenditures are now principally focused on the advancement of tamibarotene.

減少的主要原因是外部研發諮詢、合約製造的減少以及員工人數和相關費用的減少。我們的研發支出現在主要集中在他米巴羅汀的進展。

G&A expenses were $5.7 million in the third quarter of 2024, as compared to $7.8 million in the third quarter of 2023. The decrease was principally due to a reduction in head count and related expenses, consulting and facilities expenses. We reported a net loss for the third quarter of 2024 of $6.4 million or $0.16 per share compared to a net loss of $40.1 million or $1.43 per share for the same period in 2023.

2024 年第三季的一般管理費用為 570 萬美元，而 2023 年第三季為 780 萬美元。減少的主要原因是人員數量和相關費用、諮詢和設施費用的減少。我們報告 2024 年第三季的淨虧損為 640 萬美元，即每股 0.16 美元，而 2023 年同期的淨虧損為 4,010 萬美元，即每股 1.43 美元。

Cash and cash equivalents as of September 30, 2024, were $58.3 million, as compared with $79 million as of June 30, 2024. We believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into the third quarter of 2025.

截至2024年9月30日，現金及現金等價物為5,830萬美元，而截至2024年6月30日為7,900萬美元。我們相信，我們目前的現金狀況將足以滿足 2025 年第三季的預期營運費用和資本支出需求。

With that, I will turn the call over to the operator for questions.

這樣，我會將電話轉給接線生詢問問題。

(Operator Instructions) Ted Tenthoff, Piper Sandler.

（操作員說明）Ted Tenthoff、Piper Sandler。

I appreciate you taking the question, excited for data coming up right around the corner here. I just want to kind of reemphasize this. And maybe you can walk us back through what the historical aza controls in both on the label and then also most recent clinical experience? And how should we interpret the AML results in terms of how they could give us a sense for what you could show in higher-risk MDS?

感謝您提出這個問題，對即將出現的數據感到興奮。我只是想再次強調這一點。也許您可以帶我們回顧一下歷史上阿扎在標籤上以及最近的臨床經驗中所控制的內容？我們應該如何解釋 AML 結果，因為它們如何讓我們了解在高風險 MDS 中可能表現出的情況？

Ted. This is David. I'm happy to answer your question. So with respect to the aza control data, the aza-label has a complete remission rate of 17%. And that has been an accepted regulatory standard to use as a benchmark for the control in a randomized trial.

特德.這是大衛。我很高興回答你的問題。因此，就 aza 對照數據而言，aza 標籤的完全緩解率為 17%。這已成為一項公認的監管標準，可用作隨機試驗中的對照基準。

There have been meta-analyses with hundreds of trials looked at and the CR rate is the same. Obviously, there's variation from trial to trial. And in more recent trials, we've seen some have reported up in the low 20% range. More recently, I believe one of the trials had a CR rate in the control arm of 14%. So we're very comfortable that something in the mid- to high teens is likely going to be the type of CR rate one could anticipate.

對數百項試驗進行了薈萃分析，CR 率是相同的。顯然，每次試驗都存在差異。在最近的試驗中，我們看到一些報告的漲幅在 20% 的低範圍內。最近，我相信其中一項試驗的對照組 CR 率為 14%。因此，我們非常確信，CR 率可能會達到中高青少年的水平。

Also, if you look at some of the publications, the literature, for instance, the seminal paper, the Lancet Oncology paper that reported on the pivotal outcomes of the higher-risk MDS population that is included as part of the package of data in the aza label, the duration of response is rather short. I believe the aza arm had about a 3.2 months' time for response duration compared to the control arm of three months, but that was also for a CR plus PR, not just CR.

此外，如果您查看一些出版物、文獻，例如開創性論文、《柳葉刀腫瘤學》論文，該論文報告了高風險 MDS 人群的關鍵結果，該人群作為數據包的一部分包含在aza標籤，反應持續時間相當短。我相信 aza 組的反應持續時間約為 3.2 個月，而對照組為 3 個月，但這也是 CR 加 PR 的結果，而不僅僅是 CR。

Now keep in mind the time to onset of response for aza is typically relatively long. It could be anywhere in the four to five or four to six-month range. So duration of therapy can be somewhat longer because it will take the better part of the half year to achieve your response, and it will last for several months and may continue thereafter because the patients may still have some benefit.

現在請記住，aza 起效的時間通常相對較長。它可能是四到五個月或四到六個月範圍內的任何時間。所以治療的持續時間可以稍微長一​​些，因為需要半年的大部分時間才能達到你的反應，並且會持續幾個月，並且此後可能會繼續，因為患者可能仍然有一些好處。

So those are the types of expectations for the aza performance in the control. Now if you could just please -- I'm sorry, I didn't note down what your second part of your question was, and I'm happy to answer that one as well.

這些是對對照中 aza 性能的期望類型。現在，如果您可以的話——抱歉，我沒有記下您問題的第二部分是什麼，我也很高興回答這個問題。

No, that's really helpful. And then second part was just in terms of looking at the AML data -- how can we sort of infer from that to MDS, if we even can?

不，這真的很有幫助。第二部分只是查看 AML 數據——如果我們可以的話，我們如何從這些數據推斷 MDS？

Yes. So look, the AML experiment was really an experiment to see if we can leverage the apoptotic mechanism that we've seen when we've combined tamibarotene and aza with that of venetoclax. The idea was that we have very high CR/CRi rates and CR rates with tami and aza, and venetoclax itself has a similarly high rate in the mid-60% range in newly diagnosed unfit AML. So by combining all three, could we do even better? And we set up a randomized Phase II to seeing whether we can push the envelope on that.

是的。所以看，AML 實驗實際上是一個實驗，目的是看看我們是否可以利用我們在將他米巴羅汀和阿扎與維奈托克結合時看到的細胞凋亡機制。我們的想法是，我們有非常高的 CR/CRi 率以及 tami 和 aza 的 CR 率，而 Venetoclax 本身在新診斷的不適合 AML 中也有類似的高比率，在 60% 左右。那麼，透過將這三者結合起來，我們能做得更好嗎？我們設立了一個隨機的第二階段，看看我們是否可以挑戰極限。

The outcome of that study demonstrated that we are essentially maxed out on what one could achieve. So we don't view that as having any predictive value towards the outcome of the MDS trial. The MDS trial is a totally different experiment. It's testing the doublet of tami and aza. Venetoclax is not a part of that experiment. And so we really don't see a relationship between the AML outcome, and the venetoclax outcome.

這項研究的結果表明，我們基本上已經達到了極限。因此，我們認為這對 MDS 試驗的結果沒有任何預測價值。MDS 試驗是一個完全不同的實驗。它正在測試 tami 和 aza 的雙人組合。Venetoclax 並非本實驗的一部分。因此，我們確實沒有看到 AML 結果與 Venetoclax 結果之間的關係。

That said, we still continue to see high responses in tami-based regimen that occurred quickly. And we did have some encouraging activity even in the context of that AML data set, which included nice durations of response relative to the control arm, things of that nature. And we also saw rescue responses for patients who had been on the control arm who initially had responses to ven and aza, who then lost their response, just adding tami into the regimen while continuing ven/aza enabled them to restore their complete remission. And at the time of our report, I believe one patient had been back out about a year at that point, another about six months having regained responses. So we really feel that those are very important data.

也就是說，我們仍然繼續看到以塔米為基礎的治療方案迅速出現高反應。即使在 AML 資料集的背景下，我們也確實進行了一些令人鼓舞的活動，其中包括相對於控制臂的良好響應持續時間，這種性質的事情。我們也看到了對照組患者的救援反應，這些患者最初對 ven 和 aza 有反應，然後失去反應，只需在治療方案中添加 tami，同時繼續 ven/aza 即可使他們恢復完全緩解。在我們撰寫報告時，我相信一名患者已經康復了大約一年，另一名患者大約六個月後才恢復了反應。所以我們確實覺得這些都是非常重要的數據。

And the last comment I'll say about that trial result, which is important, has to do with safety. So as you know, we don't believe that tami and aza are challenging. The regimen is generally well tolerated, easily administered, it's convenient. And we saw no evidence of added myelosuppression even in the backdrop of a regimen containing venetoclax.

我要說的關於試驗結果的最後一個評論很重要，與安全有關。如您所知，我們不認為 tami 和 aza 具有挑戰性。此方案通常耐受性良好，易於管理且方便。即使在含有維奈托克的治療方案的背景下，我們也沒有看到任何增加骨髓抑制的證據。

And from our perspective, that's a very important outcome because it really just points to the tolerability of a tami-based regimen and the appropriateness for its use should our data support it, in a population like high-risk MDS, where patients are generally elderly, often have other medical conditions and comorbidities that make it complicated to give them challenging regimens, and the absence of additive myelosuppression is really important in these patients because that's often the main problem they have at the beginning of their illness, suffering from cytopenias and their complications.

從我們的角度來看，這是一個非常重要的結果，因為它實際上只是表明基於tami 的治療方案的耐受性以及在我們的數據支持的情況下，在像高危險MDS 這樣的人群（患者通常是老年人）中使用該方案的適當性，通常患有其他醫療狀況和合併症，這使得給他們提供具有挑戰性的治療方案變得複雜，並且不進行附加骨髓抑制對於這些患者來說非常重要，因為這通常是他們在患病初期面臨的主要問題，患有血球減少症和他們的病情。

So all told, we're very excited about our MDS experiment coming to fruition in just a few weeks, and we're really looking forward to sharing those outcomes with you.

總而言之，我們對 MDS 實驗在短短幾週內取得成果感到非常興奮，我們非常期待與您分享這些成果。

Phil Nadeau, TD Cowen.

菲爾·納多，TD·考恩。

Let us reiterate what Ted said, really exciting times, looking forward to the data. So I guess first question is on that data release, can you give us some sense of what you'll be able to disclose, presumably CR rate and safety, but also how much durability data will you have and anything else that you might be able to put in that press release?

讓我們重申一下Ted所說的，真的很激動人心，期待數據。所以我想第一個問題是關於該數據發布的，您能否讓我們了解您將能夠披露的內容，大概是CR 率和安全性，以及您將擁有多少耐久性數據以及您可能能夠披露的任何其他資訊放入該新聞稿？

So thanks again for that question. So again, just for anyone who's listening that doesn't have as much background and context, I just want to repeat, just to remind everybody. So this trial is -- it's a global, randomized, placebo-controlled trial of tami plus aza versus placebo plus aza. Our primary endpoint is the complete remission rate, the CR rate. So in mid-November, we're planning to report the pivotal primary endpoint outcome of the CR rate across those two arms.

再次感謝您提出這個問題。再說一次，對於那些沒有太多背景和背景的聽眾，我只想重複一遍，只是為了提醒大家。所以這項試驗是——這是一項關於 tami 加 aza 與安慰劑加 aza 對比的全球性、隨機、安慰劑對照試驗。我們的主要終點是完全緩解率，即 CR 率。因此，我們計劃在 11 月中旬報告這兩個治療組 CR 率的關鍵主要終點結果。

And this is going to be evaluated in the first 190 enrolled patients. But our study continues to enroll. We're targeting a total of 550 to support a future evaluation of the key secondary endpoint of survival -- overall survival.

這將在前 190 名入組患者中進行評估。但我們的研究仍在繼續招募。我們的目標是總共 550 個，以支持未來對關鍵的次要存活終點——整體存活率的評估。

So one thing I will say is we will not have overall survival at the time of our top line in mid-November. So you should not anticipate hearing about that because that's still an experiment in progress. But we do expect to have other secondary endpoints that are important for you to understand our CR results. So just like you're suggesting, we will obviously have data around the duration of complete response, how quickly it occurs, the time to complete response, we may have information as well about the overall response rate, which may include other responses in addition to the CR like PR and heme improvement.

所以我要說的一件事是，在 11 月中旬達到頂線時，我們不會實現整體生存。所以你不應該期望聽到這個，因為這仍然是一個正在進行的實驗。但我們確實希望有其他次要終點，這對您了解我們的 CR 結果很重要。因此，就像您所建議的那樣，我們顯然會擁有有關完整響應的持續時間、發生的速度、完成響應的時間的數據，我們可能還會有有關總體響應率的信息，其中可能還包括其他響應CR 等PR 和血紅素改善。

And importantly, and as I mentioned in my prior response, we're going to have safety data to share. And we think this is going to be critically important for you to appreciate. I know everyone is very focused on efficacy. But in this population, safety is equally important. And I think that it's critical to look forward to hearing about that as well.

重要的是，正如我在先前的回覆中提到的，我們將分享安全資料。我們認為，理解這一點對您來說至關重要。我知道大家都很注重功效。但對於這個人群來說，安全同樣重要。我認為期待聽到這一點也很重要。

These, again, are elderly patients often with other comorbidities. And taken together, I think you're going to have a very solid understanding of how tamibarotene is working in these patients with RARA gene overexpression and higher risk MDS. So looking -- again, looking forward to sharing it all with you.

這些患者都是老年患者，通常有其他合併症。總而言之，我認為您將對他米巴羅汀如何在這些 RARA 基因過度表達和高風險 MDS 患者中發揮作用有一個非常深入的了解。所以再次尋找，期待與您分享這一切。

That's very helpful. And then second question, in terms of the FDA filing, what do you need to do post the release of this primary endpoint data in order to file? Are there other things that also have to be completed that are getting to the filing? And secondarily, would you need to have a new pre-NDA meeting with the FDA prior to filing?

這非常有幫助。第二個問題，就 FDA 備案而言，在發布主要終點數據後您需要做什麼才能備案？是否還有其他需要完成的事情需要提交？其次，在提交申請之前，您是否需要與 FDA 舉行新的新藥申請前會議？

Yes. So obviously, we will have completed pulling in all of the data that has been thoroughly corroborated and validated. So when you hear about the information, you can assume it's perfect. I know that we're all working hard toward that end. And then there are other routine regulatory interactions.

是的。顯然，我們將完成所有經過徹底證實和驗證的數據的提取。因此，當您聽到這些訊息時，您可以認為它是完美的。我知道我們都在為此而努力。還有其他常規的監管互動。

There's nothing unusual that we need to do, just to go through and make sure everything is buttoned down. We've made great progress towards that objective. And -- what I can say is we'll be working as hard as possible and as quickly as possible to get that submission in and in good order, so the review is efficient and straightforward as possible.

我們不需要做任何不尋常的事情，只是檢查並確保一切都按部就班。我們已經在實現這一目標方面取得了巨大進展。而且 - 我可以說的是，我們將盡可能努力、盡快地使提交的內容井井有條，以便審核盡可能高效和直接。

We look forward to the day.

我們期待著這一天的到來。

Jason Butler, JMP Citizens.

Jason Butler，JMP 公民。

Let me add my comments about -- excited to see the data very soon. Can you maybe just talk about the commercial work that you're doing, and we'll do over the months following the release of results, if they're positive, but getting ready for commercial launch of tamibarotene in MDS?

讓我添加我的評論——很高興很快就能看到數據。您能否談談您正在做的商業工作，如果結果是積極的，我們將在結果發布後的幾個月內進行，但為 MDS 中他米巴羅汀的商業推出做好準備？

Yes. Thanks, Jason, for the question. It's Conley here. Yes. Our team has been working (inaudible) for the last year or so preparing for the launch, and we have a very detailed plan going forward to ensure that we have broad access to our drug, and we can get it to patients.

是的。謝謝傑森的提問。這裡是康利。是的。我們的團隊在過去一年左右的時間裡一直在努力（聽不清楚）為上市做準備，我們有一個非常詳細的計劃，以確保我們能夠廣泛獲得我們的藥物，並將其提供給患者。

We've already been conducting a lot of activity, I would say, prior to data. Post data, we will be accelerating a lot of that work as well. And I would say it comes in several buckets. First, sort of market awareness and ensuring that there's education around RARA biology and the effect of overexpression. We are continuing to size up the field force and looking at our infrastructure and how we'll build that to support our commercial opportunity.

我想說，在數據出現之前，我們已經開展了許多活動。發布數據後，我們也將加速許多相關工作。我想說它有幾個面向。首先，市場意識並確保圍繞 RARA 生物學和過度表達的影響進行教育。我們正在繼續擴大現場人員規模，並研究我們的基礎設施以及我們將如何建造它來支持我們的商業機會。

And then lastly, the brand plan and obviously, ensuring that there is manufacturing, milestones are being hit so that we have drugs at launch and also our diagnostic to ensure that, that's readily available for patients as well and physicians.

最後，品牌計劃，顯然，確保生產、達到里程碑，以便我們在推出時擁有藥物，並確保我們的診斷可以隨時供患者和醫生使用。

Leah Cann, Brookline Capital Markets.

Leah Cann，布魯克林資本市場。

So two questions. The first on tamibarotene, is there any plan to -- at a medical meeting on some sort of presentation to show more of the detail of the data from the recent AML results? And my second question is something from the past, 5609. I know it's been on the back burner, but if there's any thoughts or plans for how that could become relevant in the future?

那麼兩個問題。第一個是關於他米巴羅汀，是否有計劃在醫學會議上進行某種演示，以顯示近期 AML 結果數據的更多細節？我的第二個問題是過去的事情，5609。我知道它已被擱置，但是否有任何想法或計劃在未來如何變得相關？

Thanks, Leah. I'll take the first one. And -- maybe I'm not aware of the -- we did present the complete data outcome from the AML at the SOHO meeting, which happened shortly after our data disclosure. So I think that should be available, and we're happy to address any questions you may have about that if you haven't had a chance to look at that yet.

謝謝，莉亞。我就拿第一個。而且——也許我不知道——我們確實在 SOHO 會議上展示了 AML 的完整數據結果，這是在我們的數據披露後不久發生的。所以我認為這應該是可用的，如果您還沒有機會查看它，我們很樂意解決您可能對此有的任何問題。

I do have those data, apologies.

我確實有這些數據，抱歉。

Okay. Yes, no problem. And then for the second one about 5609, I'll turn that one over to Conley.

好的。是的，沒問題。然後對於第二個關於 5609 的問題，我會將其交給 Conley。

Yes, I can jump in on that one. Yes, 5609 is a tremendous asset with high potential, and we believe could be the best-in-class CDK7. I think with this asset, there's this tremendous potential across multiple tumors and to fully prosecute all of this potential, it's better suited in the hands of a larger pharma company that has the resources to do that. And so we continue to look for business development opportunities for that asset.

是的，我可以加入其中。是的，5609 是一項具有巨大潛力的巨大資產，我們相信它可能是同類中最好的 CDK7。我認為，有了這項資產，在多種腫瘤中具有巨大的潛力，為了充分發揮所有這些潛力，它更適合擁有資源的大型製藥公司手中。因此，我們繼續尋找該資產的業務發展機會。

Thank you. At this time, we have no other questions registered. I will turn the call back over to Mr. Conley Chee.

謝謝。目前，我們沒有登記任何其他問題。我會將電話轉回給 Conley Chee 先生。

Okay. Thank you, operator, and thank you, everyone, for joining, and for continuing support of Syros. It's a very exciting time here for us and potentially for the thousands of higher-risk MDS patients waiting for a better treatment option.

好的。謝謝運營商，也謝謝大家的加入以及對 Syros 的持續支持。對於我們以及成千上萬等待更好治療選擇的高風險 MDS 患者來說，這是一個非常令人興奮的時刻。

As always, please reach out to the team if you have any further questions and have a great Halloween. Thank you.

像往常一樣，如果您有任何其他問題，請聯繫我們的團隊，祝您萬聖節愉快。謝謝。

Thank you. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. And at this time, we do ask that you please disconnect your lines.

謝謝。女士們、先生們，今天的電話會議到此結束。再次感謝您的出席。此時，我們確實要求您斷開線路。