Cytokinetics Inc (CYTK) 2025 Q3 法說會逐字稿

Thank you for standing by, and welcome to the Cytokinetics Q3 2025 earnings conference call. This call is being recorded and all participants will be in a listen-only mode. (Operator Instructions)

感謝您的耐心等待，歡迎參加 Cytokinetics 2025 年第三季財報電話會議。本次通話將會被錄音，所有參與者將處於唯讀模式。（操作說明）

I would now like to turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Affairs. Please go ahead.

現在我想把電話交給 Cytokinetics 公司企業事務資深副總裁 Diane Weiser。請繼續。

Good afternoon, and thanks for joining us on the call today. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will address commercial readiness activities for aficamten.

下午好，感謝各位今天參加我們的電話會議。總裁兼執行長羅伯特布魯姆將首先概述本季及近期發展情況。執行副總裁兼商務長 Andrew Callos 將介紹 aficamten 的商業準備活動。

Fady Malik, EVP of R&D, will provide updates related to the clinical development program and medical affairs activities for aficamten. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates on the clinical development program for omecamtiv mecarbil and ulacamten.

研發執行副總裁 Fady Malik 將提供有關 aficamten 臨床開發計劃和醫學事務活動的最新資訊。資深副總裁兼首席醫療官 Stuart Kupfer 將介紹 omecamtiv mecarbil 和 ulacamten 的臨床開發計劃的最新進展。

Sung Lee, EVP and Chief Financial Officer, will provide a financial overview of the past quarter. And finally, Robert will provide closing comments and review our expected key milestones for the remainder of 2025.

執行副總裁兼財務長李成將對上一季的財務狀況進行概述。最後，羅伯特將作總結發言，並回顧我們預計在 2025 年剩餘時間內實現的關鍵里程碑。

Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements.

請注意，以下討論的部分內容，包括我們對問題的回答，包含與未來事件和績效相關的陳述，而不是歷史事實，構成前瞻性陳述。我們的實際結果可能與這些前瞻性聲明中預測的結果有重大差異。

Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings, including our current report regarding our third quarter 2025 financial results filed on Form 8-K that was furnished to the SEC today. We undertake no obligation to update any forward-looking statements after this call.

有關可能導致我們的實際業績與這些前瞻性聲明中業績存在重大差異的因素的更多信息，請參閱我們向美國證券交易委員會提交的文件，包括我們今天向美國證券交易委員會提交的關於 2025 年第三季度財務業績的 8-K 表格報告。我們不承擔在本次電話會議後更新任何前瞻性聲明的義務。

Now I will turn the call over to Robert.

現在我將把電話交給羅伯特。

Thank you, Diane, and thank you all for joining us on the call today. The past quarter was highly productive and defining for Cytokinetics. We made significant progress across the company's priority objectives as we advance towards the end of the year when we hope to achieve our first potential FDA approval of aficamten for patients with oHCM. Our major accomplishments this past quarter were dedicated to preparing for that milestone, including continuing constructive engagements with FDA, completing key commercial launch readiness activities and fortifying our capital structure.

謝謝黛安，也謝謝大家今天參加我們的電話會議。過去一個季度對Cytokinetics來說是碩果累累且具有決定性意義的。隨著我們邁向年底，希望能夠獲得美國食品藥物管理局 (FDA) 對 aficamten 用於治療 oHCM 患者的第一個潛在批准，我們在公司優先目標方面取得了重大進展。我們在上個季度取得的主要成就都致力於為這一里程碑做好準備，包括繼續與FDA進行建設性溝通、完成關鍵的商業上市準備活動以及加強我們的資本結構。

During the quarter, we held our late-cycle meeting with the FDA. As we previously disclosed during the meeting, we discussed our proposed REMS program, including elements to assure safe use, or ETASU, as well as anticipated post-marketing requirements. Prior to the meeting, we had received FDA's responses to our proposed REMS and label for aficamten. And based on our exchanges and discussions with FDA to date, we continue to expect a differentiated label and risk mitigation profile for aficamten if approved by the FDA.

本季度，我們與FDA舉行了後期週期會議。正如我們在先前的會議上所披露的那樣，我們討論了我們提出的 REMS 計劃，包括確保安全使用 (ETASU) 的要素，以及預期的上市後要求。在會議召開之前，我們已經收到了 FDA 對我們提出的 aficamten 的 REMS 和標籤的回應。根據我們迄今為止與 FDA 的交流和討論，我們仍然期望如果 aficamten 獲得 FDA 批准，它將具有差異化的標籤和風險緩解方案。

We've completed all GCP inspections by the FDA with no observations noted. Moreover, to date, we have not been notified of the intention of FDA to conduct pre-approval inspections. We look forward to continuing our dialogue with FDA ahead of the PDUFA date. In recent months, we've also leaned further into commercial readiness with the onboarding of our commercial field sales colleagues and the finalization of promotional campaigns and patient support programs, with objective to further differentiate how we show up commercially.

我們已完成FDA的所有GCP檢查，未發現任何問題。此外，迄今為止，我們尚未收到FDA關於進行上市前檢查的通知。我們期待在 PDUFA 日期之前繼續與 FDA 進行對話。近幾個月來，我們也進一步加強了商業準備工作，包括招募商業現場銷售同事、最終確定促銷活動和病患支援計劃，目的是進一步凸顯我們在商業上的差異化優勢。

At the same time, in Q3, we achieved an important clinical milestone within the development program for aficamten. We presented the positive primary results from MAPLE-HCM, which demonstrated superiority of aficamten to metoprolol in patients with oHCM, challenging the long-held status quo of treatment in this disease.

同時，在第三季度，我們在 aficamten 的研發項目中取得了重要的臨床里程碑。我們展示了 MAPLE-HCM 的積極主要結果，該結果表明，在 oHCM 患者中，aficamten 優於美托洛爾，挑戰了該疾病長期以來的治療現狀。

Our intention is to file a supplemental NDA for MAPLE-HCM following its potential initial FDA approval. But in the meantime, we believe these results may help catalyze certain prescribers and help unlock more of the market upon the initial introduction of aficamten as may result in increased commercial launch velocity.

我們計劃在 MAPLE-HCM 獲得 FDA 初步批准後，提交補充新藥申請。但同時，我們相信這些結果可能會促使某些處方醫生開立處方，並在 aficamten 首次推出時幫助釋放更多市場份額，從而加快其商業上市速度。

Following closely behind the potential approval and launch of aficamten in the United States is the expected potential approval of aficamten in the EU. During the quarter, we received the Day 120 List of Questions from the EMA, and we subsequently submitted our responses. More recently, we've continued EMA interactions, and we're preparing Day 180 responses. We're encouraged by ongoing interactions, and we expect a final decision from the European Commission in the first half of next year, even possibly on the earlier side of the year, given the pace of our review to date.

在美國可能獲得批准並上市之後，預計 aficamten 也將在歐盟獲得批准。本季度，我們收到了歐洲藥品管理局 (EMA) 的第 120 天問題清單，隨後我們提交了我們的答覆。最近，我們繼續與 EMA 進行互動，並且正在準備第 180 天的回應。我們對目前的互動感到鼓舞，鑑於我們迄今為止的審查進度，我們預計歐盟委員會將在明年上半年做出最終決定，甚至有可能在明年年初就做出決定。

In parallel, our European launch readiness activities are well underway, focused on market access planning, medical education and engagement with the cardiology community and to ensure a strong foundation for a successful introduction of aficamten in Europe. We also continue to work closely with Sanofi to support the potential approval of aficamten in China to further broaden the global opportunity and reinforce our commitment to making this therapy available to patients worldwide.

同時，我們在歐洲的上市準備活動也進展順利，重點是市場准入計劃、醫學教育以及與心臟病學界的互動，以確保為在歐洲成功推出 aficamten 奠定堅實的基礎。我們也將繼續與賽諾菲密切合作，支持阿菲卡汀在中國獲得潛在批准，以進一步擴大全球機遇，並加強我們致力於讓世界各地的患者都能獲得這種療法的承諾。

To achieve all of this, we're fortunate to have a strong balance sheet, which we further bolstered during the quarter through our convertible note offering. As Sung will elaborate, this transaction helps not only to provide additional capital at this important time, but also financial flexibility. And lastly, we continue to build momentum across our broader pipeline at this important inflection point in our corporate development, reflecting our ongoing commitment to sustained innovation and longer-term growth.

為了實現這一切，我們很幸運地擁有強勁的資產負債表，並且在本季度透過可轉換債券發行進一步增強了這一狀況。正如 Sung 將要詳細闡述的那樣，這筆交易不僅有助於在這個重要時刻提供額外的資金，而且還有助於提供財務靈活性。最後，在我們公司發展的重要轉折點上，我們繼續在更廣泛的產品線中保持發展勢頭，這反映了我們對持續創新和長期成長的持續承諾。

With that, I'll turn the call over now to Andrew, please.

那麼，我現在把電話交給安德魯了。

Thanks, Robert. We continue to make strong progress with commercial readiness activities towards the potential FDA approval of aficamten next month. As Robert mentioned, our interactions with the FDA to date have reinforced our expectations for a differentiated risk mitigation profile anchored in REMS and label, and we have confirmed our go-to-market plans and promotional campaign.

謝謝你，羅伯特。我們繼續在商業準備活動方面取得強勁進展，預計在下個月獲得 FDA 對 aficamten 的批准。正如羅伯特所提到的，我們迄今為止與 FDA 的互動強化了我們對基於 REMS 和標籤的差異化風險緩解方案的期望，並且我們已經確認了我們的上市計劃和推廣活動。

Following anticipated approval in December, our launch process will begin immediately. Within days, our website, patient navigators, patient support services will go live to begin supporting physicians and patients on their treatment journey. Shortly thereafter, in early January, our fully trained cardiovascular sales and medical teams will be in the field engaging healthcare professionals with full commercial launch, inclusive of product availability and REMS operations to follow.

預計在12月獲得批准後，我們的產品發布流程將立即啟動。幾天之內，我們的網站、病患導航員和病患支援服務將上線，開始為醫生和病患的治療過程提供支援。此後不久，在 1 月初，我們訓練有素的心血管銷售和醫療團隊將進入一線，與醫療保健專業人員接觸，全面開展商業推廣，包括產品供應和後續的 REMS 運營。

To ensure a seamless and impactful launch, we've invested deeply in assembling the right team and creating the right infrastructure. Over the last several months, we've built a strong and highly experienced cardiovascular sales team with our field sales representatives averaging over 20 years of industry experience and 14 years of cardiovascular experience. These are seasoned sales professionals who understand the nuances of launching a new medicine in a specialized market.

為了確保順利且有影響力的發布，我們投入大量資金組建了合適的團隊並創建了合適的基礎設施。在過去的幾個月裡，我們組建了一支實力雄厚、經驗豐富的心血管銷售團隊，我們的現場銷售代表平均擁有超過 20 年的行業經驗和 14 年的心血管經驗。這些都是經驗豐富的銷售專業人士，他們了解在專業市場推出新藥的各種細微差別。

Our sales team is on board and completing training to ensure that our full team will be prepared to begin HCP engagement within days of FDA approval. A subset of our sales team has already been in the field since early September, introducing Cytokinetics to key oHCM HCPs and providing disease education. Core to our launch strategy and consistent with the value and our vision of a differentiated patient-centric treatment experience, one that has been built from the ground up specifically for aficamten.

我們的銷售團隊已經到位，正在完成培訓，以確保我們的整個團隊能夠在獲得 FDA 批准後的幾天內開始與 HCP 接洽。自 9 月初以來，我們銷售團隊的一部分成員已經深入一線，向關鍵的 oHCM 醫療保健專業人員介紹 Cytokinetics，並提供疾病教育。這是我們上市策略的核心，也與我們以患者為中心的差異化治療體驗的價值和願景一致，這種體驗是從零開始專門為 aficamten 構建的。

Our approach is designed to be simple and integrated across all touch points for both HCPs and patients. At the heart of this model is a highly qualified team of patient navigators who will serve as a central point of contact throughout the patient journey. These navigators are also on board and have completed their training or are completing their training and preparations ahead of their anticipated approval to ensure readiness.

我們的方法旨在簡單易行，並貫穿醫護人員和患者的所有接觸點。此模式的核心是一支高素質的病患導航員團隊，他們將在病患的整個就醫過程中作為中心聯絡點。這些導航員也已登船，他們已經完成了培訓，或者正在完成培訓和準備工作，以便在獲得批准之前做好準備。

We've developed a distinct and compelling promotional HCP campaign that highlights the differentiated characters of aficamten and key attributes of our REMS program. We believe this campaign will clearly communicate the clinical value of aficamten and support broad awareness among cardiologists. Ahead of launch, we continue to engage with payers to educate them on the evidence from our clinical trial as well as the clinical and economic burden of HCM.

我們制定了一項獨特且引人注目的 HCP 推廣活動，重點是 aficamten 的差異化特性和我們 REMS 專案的關鍵屬性。我們相信，這項活動將清晰地傳達 aficamten 的臨床價值，並提高心臟科醫生的廣泛認知。在產品上市之前，我們將繼續與支付方溝通，向他們介紹我們臨床試驗的證據以及 HCM 的臨床和經濟負擔。

We remain confident in our ability to see parity access by the second half of 2026. Importantly, our strategy is comparable access with focus to differentiate based on the clinical profile of aficamten, our REMS program and our comprehensive bespoke patient support services. As we stand several weeks out from our potential approval, I'm pleased with our commercial preparation and launch readiness, and I'm confident in our ability to execute quickly and effectively if aficamten is approved.

我們仍有信心在 2026 年下半年實現平價醫療。重要的是，我們的策略是提供可比較的獲取途徑，重點是根據 aficamten 的臨床特性、我們的 REMS 計劃和我們全面的客製化患者支援服務來區分。距離我們可能獲得批准還有幾週時間，我對我們的商業準備和上市準備感到滿意，並且我有信心，如果 aficamten 獲得批准，我們將能夠迅速有效地執行。

As we look ahead to measuring the pace and velocity of our launch after approval, we will focus on a few key metrics. First, HCP prescribing breadth as measured by the number of HCPs who are actively writing prescriptions.

展望未來，在獲得批准後，我們將衡量產品上市的速度和節奏，並專注於幾個關鍵指標。首先，以積極開立處方的醫護人員數量來衡量醫護人員的處方廣度。

Second, prescribing depth as measured by the volume of prescriptions and HCP writes for aficamten. To achieve rapid uptake, we will quickly engage existing CMI prescribers with an eye to expanding the prescribing universe to those who treat HCM, but have yet to prescribe a CMI. More specifically, our goal for our field-based cardiology account specialists was to reach nearly all of the estimated 650 HCPs or approximately 80% of the HCM prescribing to date within the first few weeks of January.

其次，處方深度以處方量和 HCP 為 aficamten 開立的處方數量來衡量。為了實現快速推廣，我們將迅速與現有的 CMI 處方醫生接洽，著眼於擴大處方範圍，將 CMI 處方醫生納入治療 HCM 但尚未開立 CMI 處方的醫生群體。更具體地說，我們為現場心臟病客戶專員設定的目標是在 1 月的前幾週內聯繫到估計的 650 名 HCP（或約佔迄今為止 HCM 處方量的 80%）。

And third metric is the volume of patients on aficamten. We will be closely monitoring and supporting patient uptake, including time of conversion to commercial drug, adherence, compliance and persistency. These measures will provide us early insights into the speed and trajectory of our launch rate of change and overall strength of our commercial execution focused on category growth and overall preferential share in an expanding market.

第三個指標是使用 aficamten 的患者數。我們將密切監測和支持患者的用藥情況，包括轉換為商業藥物的時間、依從性、遵醫囑性和持續用藥情況。這些措施將使我們儘早了解我們在不斷擴大的市場中，以品類成長和整體優先份額為重點的商業執行的速度和軌跡，以及變革的推出速度和軌跡。

Finally, our attention is not only on the US, but also in the EU, where we've made meaningful progress in preparing for potential commercial launch of aficamten in that geography. We recently hired a General Manager for Italy alongside colleagues that are already on board in the UK, France and Germany and also began recruiting and hiring our full German commercial team inclusive of our field sales reps.

最後，我們的注意力不僅集中在美國，也集中在歐盟，我們在為aficamten在該地區的潛在商業化推出做準備方面取得了實質進展。我們最近聘請了一位義大利總經理，與英國、法國和德國的同事一起，開始招募和聘用我們完整的德國商業團隊，包括我們的現場銷售代表。

In addition, we are preparing dossiers for upcoming discussions with HA bodies across key EU countries, with potential EMA approval expected in the first half of 2026, we remain on track for a launch in Germany in the first half of 2026 with other geographies to follow in '26 and '27.

此外，我們正在準備文件，以便與歐盟主要國家的衛生署進行討論。預計 EMA 將於 2026 年上半年批准該產品，我們仍按計劃於 2026 年上半年在德國推出，其他地區將於 2026 年和 2027 年陸續推出。

With that, I'll turn the call over to Fady.

接下來，我將把電話交給法迪。

Thanks, Andrew. During the quarter, we are pleased to have presented new data that further reinforces the differentiation of aficamten and its potential for patients with HCM. Most notably, at the ESC Congress, we presented positive primary results from MAPLE-HCM, which were simultaneously published in the New England Journal of Medicine. The results which show superiority of aficamten to metoprolol represent a watershed moment in treatment of oHCM.

謝謝你，安德魯。本季度，我們很高興地展示了新的數據，進一步強化了 aficamten 的差異化優勢及其對 HCM 患者的潛力。最值得一提的是，在 ESC 大會上，我們展示了 MAPLE-HCM 的正面初步結果，這些結果同時發表在《新英格蘭醫學雜誌》上。研究結果表明，阿菲卡坦優於美托洛爾，這代表了肥厚型心肌病變治療的一個分水嶺時刻。

While patients treated with aficamten experienced a significant improvement in exercise capacity, those on metoprolol showed a decline, challenging the long-standing rationale for beta blocker used as the standard-of-care therapy in this disease. This finding has resonated strongly across the cardiology community as we heard firsthand from many healthcare professionals and key opinion leaders on site at ESC.

雖然接受 aficamten 治療的患者運動能力顯著提高，但接受美托洛爾治療的患者運動能力卻有所下降，這挑戰了長期以來將 β 受體阻斷劑作為該疾病標準治療藥物的理論依據。這項發現引起了心臟病學界的強烈共鳴，我們在 ESC 現場直接聽取了許多醫療保健專業人員和關鍵意見領袖的意見。

In addition to improving exercise capacity, aficamten also produced larger improvements in symptoms, gradients and cardiac biomarkers as compared to metoprolol. Improvements were consistent across all prespecified subgroups and confidence of the robustness of the findings. Importantly, adverse events were similar in the two groups and the safety of aficamten observed in MAPLE-HCM was consistent with previous studies.

除了提高運動能力外，與美托洛爾相比，阿菲卡坦在症狀、梯度和心臟生物標記方面也產生了更大的改善。所有預先設定的亞組均取得了一致的改善，並且對研究結果的穩健性充滿信心。重要的是，兩組的不良事件相似，MAPLE-HCM 中觀察到的 aficamten 的安全性與先前的研究一致。

To that end, as the evidence of aficamten expands, so too does our confidence in its consistent safety profile. An updated integrated safety analysis representing nearly 700 patient years of exposure from REDWOOD-HCM, SEQUOIA-HCM, FOREST-HCM, and now MAPLE-HCM as well, aficamten was shown to be well tolerated with a low incidence of LVEF less than 50% over extended periods of exposure, with no occurrences associated with a serious event of heart failure.

由此可見，隨著 aficamten 的證據不斷增加，我們對它持續安全性能的信心也越來越強。一項更新的綜合安全性分析代表了 REDWOOD-HCM、SEQUOIA-HCM、FOREST-HCM 以及現在的 MAPLE-HCM 近 700 患者年的暴露情況，結果表明 aficamten 耐受性良好，在長期暴露期間 LVEF 低於 50% 的發生率較低，且未發生與嚴重衰竭的情況。

Long-term treatment with aficamten has also been shown to not be associated with an increased risk for atrial fibrillation. Looking ahead and coming up this month at the AHA scientific session, pleased to have three late-breaker presentations with additional data from MAPLE-HCM providing new insights into these results.

長期使用阿菲卡汀治療也已被證明與心房顫動風險增加無關。展望未來，在本月即將舉行的 AHA 科學會議上，很高興有三場最新研究成果報告，其中包含來自 MAPLE-HCM 的額外數據，為這些結果提供了新的見解。

With respect to the ongoing clinical trial program for aficamten, the next major data milestone for us will be the readout of ACACIA-HCM, the pivotal Phase 3 trial in nHCM. We completed enrollment of the primary cohort, excluding Japan, in the first quarter of 2025, and we now expect to report the top line results from this cohort of ACACIA-HCM in the second quarter of 2026.

關於 aficamten 的正在進行的臨床試驗項目，我們下一個重要的數據里程碑將是 ACACIA-HCM 的讀出結果，這是 nHCM 的關鍵性 3 期試驗。2025 年第一季度，我們完成了除日本以外的主要隊列的招募工作，現在預計將於 2026 年第二季度公佈 ACACIA-HCM 該隊列的主要結果。

During the third quarter, we completed enrollment of patients in the Japan cohort, closing enrollment of ACACIA-HCM worldwide. If the results of ACACIA-HCM are positive, it represents an opportunity to address the needs of a highly underserved patient population and an important opportunity to expand the therapeutic impact of aficamten. Our belief in the therapeutic potential of aficamten in nHCM is founded in the existing body of evidence from the nHCM cohort of REDWOOD-HCM and strengthened by their longer term follow-up in the FOREST-HCM trial as recently reported.

第三季度，我們完成了日本隊列的病患招募，ACACIA-HCM 全球招募工作也隨之結束。如果 ACACIA-HCM 的結果為陽性，則代表著滿足嚴重缺乏服務的患者群體的需求的機會，以及擴大 aficamten 治療影響的重要機會。我們相信 aficamten 在 nHCM 治療中的治療潛力，這基於 REDWOOD-HCM 研究的 nHCM 患者隊列的現有證據，並且最近報道的 FOREST-HCM 試驗的長期隨訪結果也加強了這一信念。

At the Heart Failure Society of America meeting in late September, we presented new data covering at least 96 weeks of treatment in these nHCM patients. What you saw, albeit in an open-label setting was that 79% of the patients treated with aficamten improved by at least one NYHA functional class. Patients also had a mean increase in their KCCQ Clinical Summary Score of 11.2 points as well as improvements in cardiac biomarkers.

在 9 月下旬舉行的美國心臟衰竭協會會議上，我們展示了涵蓋這些 nHCM 患者至少 96 週治療的新數據。儘管是在開放標籤環境下進行的，但結果顯示，接受 aficamten 治療的患者中有 79% 的 NYHA 功能等級至少提高了一個等級。患者的 KCCQ 臨床總結評分平均提高了 11.2 分，心臟生物標記也有所改善。

Few patients experienced LVEF less than 50 and all instances were reversible after down titration or short treatment interruption. We are hopeful that these data may be replicated in the results of ACACIA-HCM given the similarity in patient populations and dosing scheme involved.

少數患者的左心室射血分數低於 50，所有病例在降低劑量或短暫中斷治療後均可逆轉。鑑於患者群體和給藥方案的相似性，我們希望這些數據能在 ACACIA-HCM 的結果中得到重複驗證。

Alongside our clinical research, our Medical Affairs organization has been very active, engaging the HCM community broadly as we prepare for launches in both the US and Europe. They conducted recent advisory board meetings in the US and Europe and met with the HCM community of physicians at ESC and HFSA alongside institutional visits in their territories. Our team of therapeutic medical scientists in Germany is in place, and we now have medical directors located in Germany, the UK and France, supported by our regional group located in Switzerland.

除了臨床研究之外，我們的醫療事務部門也非常活躍，廣泛參與 HCM 社群的活動，為在美國和歐洲的上市做準備。他們最近在美國和歐洲舉行了諮詢委員會會議，並在其轄區內與 ESC 和 HFSA 的 HCM 醫生群體進行了會面，同時也進行了機構訪問。我們在德國的治療醫學科學家團隊已經到位，目前我們在德國、英國和法國都設有醫療總監，並由位於瑞士的區域團隊提供支援。

Our field team in the US have now also partnered with their newly hired sales colleagues to compliantly conduct introductory meetings with key opinion leaders and healthcare professionals.

我們在美國的業務團隊現在也與新聘的銷售同事合作，以合規的方式與關鍵意見領袖和醫療保健專業人員進行介紹性會議。

Now I'll turn it over to Stuart to provide updates on our ongoing clinical trials in heart failure.

現在我將把發言權交給斯圖爾特，讓他介紹我們正在進行的心臟衰竭臨床試驗的最新進展。

Thanks, Fady. During the quarter, we continued conduct of COMET-HF, the confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction less than 30%. These are patients who remain at high risk for frequent hospitalization and mortality despite receiving maximally tolerated guideline-directed therapies. COMET-HF is designed to confirm the findings of the positive Phase 3 clinical trial of GALACTIC-HF in a more severe HFrEF population in whom we believe this mechanism may be able to deliver greater cardiovascular risk reduction.

謝謝你，法迪。本季度，我們繼續進行 COMET-HF，這是一項針對射血分數嚴重降低（小於 30%）的有症狀心臟衰竭患者的 omecamtiv mecarbil 的 3 期確證性臨床試驗。即使接受了最大耐受劑量的指南指導治療，這些患者仍然面臨頻繁住院和死亡的高風險。COMET-HF 旨在驗證 GALACTIC-HF 的 3 期臨床試驗的正面結果，研究對象為更嚴重的 HFrEF 患者，我們認為這種機制可能能夠為這類患者帶來更大的心血管風險降低。

In October, we conducted an investigator meeting in Europe, which revealed tremendous enthusiasm for COMET-HF. Many of the investigators had participated in GALACTIC-HF, and it was really wonderful to see their continued enthusiasm for the potential benefits of omecamtiv mecarbil. We now have over 75% of sites in North America and Europe activated and are continuing to activate sites around the world. We expect to continue patient enrollment in COMET-HF into 2026.

10 月份，我們在歐洲舉行了一次研究人員會議，會議顯示人們對 COMET-HF 表現出極大的熱情。許多研究人員都參與了 GALACTIC-HF 研究，看到他們對 omecamtiv mecarbil 的潛在益處仍然保持著熱情，真是太好了。目前，我們在北美和歐洲已啟動超過 75% 的站點，並且正在繼續啟動世界各地的站點。我們預計將繼續在 COMET-HF 計畫中招募患者至 2026 年。

We also continue to conduct AMBER-HFpEF, the Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction of at least 60%. By inhibiting cardiac myosin to attenuate hypercontractility, ulacamten is uniquely positioned to address the underlying diastolic dysfunction in this subgroup of HFpEF patients. HFpEF represents approximately half of all heart failure cases and remains an area of high unmet need with limited treatment options.

我們也繼續進行 AMBER-HFpEF，這是 ulacamten 在射血分數至少為 60% 的有症狀心臟衰竭患者中的​​ 2 期臨床試驗。ulacamten 透過抑制心肌肌球蛋白來減弱心肌過度收縮，因此在解決 HFpEF 患者這一亞組的潛在舒張功能障礙方面具有獨特的優勢。HFpEF 約佔所有心臟衰竭病例的一半，由於治療選擇有限，仍然是亟需治療的領域。

Enrollment in AMBER-HFpEF is progressing, and we expect to complete cohorts 1 and 2 in 2026 to inform FDA interactions and the decisions to proceed towards potential registrational studies. We're pleased with the continued execution of these ongoing clinical trials, each in a different form of heart failure, which reflects our continuing commitment to further advance innovative medicines within our specialty cardiology franchise.

AMBER-HFpEF 的招募工作正在順利進行，我們預計將於 2026 年完成第 1 組和第 2 組，以便為與 FDA 的互動以及推進潛在的註冊研究的決策提供資訊。我們對正在進行的臨床試驗的持續進行感到滿意，每項試驗都針對不同類型的心臟衰竭，這反映了我們不斷致力於在心臟病專科領域進一步推進創新藥物研發的承諾。

And with that, I'll pass it to Sung.

那麼，我就把麥克風交給宋了。

Thanks, Stuart. We're pleased to report our third quarter of 2025 financial results.

謝謝你，斯圖爾特。我們很高興向大家公佈2025年第三季的財務表現。

Starting with the balance sheet. We finished the third quarter with approximately $1.25 billion in cash and investments compared to $1 billion at the end of the second quarter of 2025. Our cash and investments increased quarter-over-quarter due to the net proceeds of $327 million received from the issuance of $750 million aggregate principal amount of the convertible senior notes due 2031 and concurrent exchange of $399.5 million aggregate principal amount of our 2027 notes.

首先來看資產負債表。第三季末，我們的現金和投資約為 12.5 億美元，而 2025 年第二季末為 10 億美元。由於發行總額為 7.5 億美元的 2031 年到期可轉換優先票據，以及同時交換總額為 3.995 億美元的 2027 年到期票據，我們的現金和投資環比增加 3.27 億美元。

These transactions together accomplish our goal of providing the company with financial flexibility ahead of the potential launch of aficamten for oHCM. Excluding the net proceeds received from this transaction, our cash would have declined by approximately $112 million quarter-over-quarter.

這些交易共同實現了我們的目標，在 aficamten 可能用於治療 oHCM 之前，為公司提供財務靈活性。如果排除本次交易所獲得的淨收益，我們的現金將比上一季減少約 1.12 億美元。

In October, we received proceeds of $100 million from the Tranche 5 loan provided by Royalty Pharma, which will enable us to finish 2025 with approximately $1.2 billion in cash and investments. R&D expenses for the second quarter were $99.2 million compared to $84.6 million for the same period in 2024. The increase was primarily due to advancing our clinical trials and higher personnel-related costs, including stock-based compensation.

10 月份，我們收到了 Royalty Pharma 提供的第五期貸款的 1 億美元收益，這將使我們能夠在 2025 年底擁有約 12 億美元的現金和投資。第二季的研發費用為 9,920 萬美元，而 2024 年同期為 8,460 萬美元。此次成長主要是由於臨床試驗的推進和人員相關成本的增加，包括股票選擇權補償。

G&A expenses for the third quarter of 2025 were $69.5 million compared to $56.7 million for the same period in 2024. The increase was primarily due to investments towards commercial readiness and higher personnel-related costs, including stock-based compensation. Net loss for the third quarter of 2025 was $306.2 million or $2.55 per share compared to a net loss of $160.5 million or $1.36 per share for the same period in 2024.

2025 年第三季的一般及行政費用為 6,950 萬美元，而 2024 年同期為 5,670 萬美元。成長的主要原因是為實現商業化準備而進行的投資以及更高的人員相關成本，包括股票選擇權激勵。2025 年第三季淨虧損為 3.062 億美元，即每股虧損 2.55 美元，而 2024 年同期淨虧損為 1.605 億美元，即每股虧損 1.36 美元。

The net loss for the third quarter of 2025 includes the debt conversion expense of $121.2 million due to the induced exchange of $399.5 million of aggregate principal amount of the 2027 notes. Turning to our financial guidance.

2025 年第三季的淨虧損包括因 2027 年到期票據本金總額 3.995 億美元的強制交換而產生的 1.212 億美元的債務轉換費用。接下來，我們來看看財務上的建議。

We are narrowing our full year 2025 GAAP operating expense range to $680 million to $700 million from the previous range of $670 million to $710 million. Stock-based compensation that is included in GAAP operating expense is expected to be between $110 million and $120 million. Excluding stock-based compensation from GAAP operating expense results in a range of $560 million to $590 million.

我們將 2025 年全年 GAAP 營運費用範圍從先前的 6.7 億美元至 7.1 億美元縮小至 6.8 億美元至 7 億美元。計入 GAAP 營運費用的股票選擇權補償預計在 1.1 億美元至 1.2 億美元之間。如果從 GAAP 營運費用中剔除股票選擇權費用，結果為 5.6 億美元至 5.9 億美元。

As we near the close of 2025, we have taken important steps to add flexibility and strength to our balance sheet. This positions us well ahead of the PDUFA date for aficamten in the US, potential approval in the EU in the first half of 2026 and the readout of results from ACACIA-HCM expected in the second quarter of 2026.

隨著 2025 年即將結束，我們已採取重要措施，增強資產負債表的彈性和實力。這使我們遠遠領先 aficamten 在美國的 PDUFA 日期、2026 年上半年在歐盟的潛在批准以及預計在 2026 年第二季度公佈的 ACACIA-HCM 結果。

With that, I'll hand it back to Robert.

就這樣，我把它還給羅伯特。

Thank you, Sung. This quarter, we made substantial progress across the company. We reported additional data that continues to validate our pioneering and leading science, and reinforce the differentiated profile of aficamten, while also finalizing our commercial launch readiness and maintaining momentum across our pipeline. These accomplishments underscore the focus, rigor and dedication of our teams as we move closer to the most important milestone in our company's history.

謝謝你，宋。本季度，公司各方面都取得了實質進展。我們公佈了更多數據，這些數據繼續驗證了我們開創性和領先的科學成果，並強化了 aficamten 的差異化特性，同時完成了我們的商業發布準備工作，並保持了我們整個產品線的良好勢頭。這些成就凸顯了我們團隊的專注、嚴謹和奉獻精神，我們正朝著公司歷史上最重要的里程碑邁進。

To help us prepare for this pivotal phase in the company's evolution, we were pleased to welcome James Daly to our Board of Directors during the quarter. Jim brings more than 30 years of global biopharma commercial leadership experience including long-standing senior commercialization expertise from his time as Chief Commercial Officer at Incyte and in senior commercial roles at Amgen, alongside now Board roles at leading commercial biopharma companies.

為了幫助我們為公司發展中的這一關鍵階段做好準備，我們很高興在本季度迎來 James Daly 加入我們的董事會。Jim 擁有超過 30 年的全球生物製藥商業領導經驗，包括擔任 Incyte 首席商務官和 Amgen 高級商業職位期間積累的長期高級商業化專業知識，以及目前在領先的商業生物製藥公司擔任董事會成員。

We look forward to his guidance and oversight now as a Board member at Cytokinetics.

我們期待他作為 Cytokinetics 董事會成員，給予我們指導和監督。

As we approach our first potential FDA approval at Cytokinetics, I want to thank our employees, our partners and our shareholders for their continued trust and support. We're approaching a pivotal moment in our company's history, standing at an important threshold after many years of disciplined investment in our science, pipeline and infrastructure as well as capital structure, and that will enable our planned transition to a fully integrated commercial company.

隨著 Cytokinetics 即將獲得 FDA 的首個潛在批准，我要感謝我們的員工、合作夥伴和股東們一直以來的信任和支持。我們正接近公司歷史上的一個關鍵時刻，經過多年對科學、研發管線、基礎設施以及資本結構的嚴格投資，我們正站在一個重要的門檻上，這將使我們能夠按計劃轉型為一家完全一體化的商業公司。

At this juncture, we are not spectators, but instead, we are active participants in shaping the next chapter for our company. Our near-term focus remains on potential regulatory approvals and commercial launch and velocity. I'm confident in the strength of our teams and the clarity of our shared vision now translating to execution.

此時此刻，我們不再是旁觀者，而是積極參與者，共同塑造公司的未來篇章。我們近期的重點仍然是潛在的監管批准、商業發布和速度。我對我們團隊的實力以及我們共同願景的清晰度充滿信心，現在這些都將轉化為實際行動。

With that, I'll recap our upcoming milestones. For aficamten, we expect to advance NDA review activities with FDA to support the potential US approval of aficamten by the end of the year. We expect to advance go-to-market strategies and continue launch preparations for aficamten in the United States. We expect to continue go-to-market planning in Germany and expand commercial readiness activities in Europe in 2025 and in preparation for potential approval of aficamten by the EMA in the first half of 2026.

接下來，我將概述我們即將迎來的重要里程碑。對於 aficamten，我們預計將推動與 FDA 的 NDA 審查活動，以支持 aficamten 在今年年底前獲得美國批准。我們期望推動市場推廣策略，並繼續為 aficamten 在美國的上市做準備。我們預計將在 2025 年繼續在德國進行市場推廣計劃，並在歐洲擴大商業準備活動，為 aficamten 在 2026 年上半年獲得 EMA 的潛在批准做好準備。

We expect to continue to coordinate with Sanofi to support the potential approval of aficamten in China, pending approval by the NMPA. And we expect to report top line results from the primary cohort of ACACIA-HCM in the second quarter of 2026 and continue patient enrollment and conduct of the adolescent cohort in CEDAR-HCM into 2026.

我們期待繼續與賽諾菲協調，以支持 aficamten 在中國獲得批准，但需等待國家藥品監督管理局的批准。我們預計將於 2026 年第二季公佈 ACACIA-HCM 主要隊列的初步結果，並繼續在 2026 年進行 CEDAR-HCM 青少年隊列的患者招募和研究。

For omecamtiv mecarbil, we expect to continue patient enrollment and conduct of COMET-HF through 2026. For ulacamten, we expect to continue patient enrollment and conduct of AMBER-HFpEF through 2026. And finally, for preclinical development and ongoing research, we expect to continue ongoing preclinical development and research activities directed to additional muscle biology-focused programs.

對於 omecamtiv mecarbil，我們預計將繼續招募患者並進行 COMET-HF 研究至 2026 年。對於 ulacamten，我們預計將繼續招募患者並進行 AMBER-HFpEF 研究至 2026 年。最後，在臨床前開發和持續研究方面，我們預計將繼續進行以肌肉生物學為重點的其他項目的臨床前開發和研究活動。

And operator, with that, we can now open up the call to questions, please.

接線員，現在可以開始接受提問了。

(Operator Instructions) Gena Wang, Barclays.

（操作說明）Gena Wang，巴克萊銀行。

I have tons of questions on approval, but I will save that for my peers. So I will ask one question regarding ACACIA data. I think you did mention that the data will be coming out in 2Q '26. So as we remember that you added pVO2 as a dual primary endpoint for regulatory feedback from Europe and Japan. So technically, the drug should receive approval as long as you hit one of the two primary endpoints.

關於審核流程我有很多問題，但我會把這些問題留給我的同事們。所以我想問一個關於ACACIA數據的問題。我想你確實提到過，數據將在 2026 年第二季公佈。所以我們記得，您加入了 pVO2 作為來自歐洲和日本監管回饋的雙重主要終點。因此，從技術上講，只要達到兩個主要終點之一，該藥物就應該獲得批准。

But in the case of missing pVO2, do you anticipate any issue of approval in Europe and Japan? I assume US will be totally okay as long as you're hitting one endpoint.

但是，如果缺少 pVO2，您是否預計在歐洲和日本會遇到任何審批問題？我估計只要你只造訪一個終點站，美國那邊就完全沒問題。

I'll ask Fady to respond to that.

我會請法迪對此作出回應。

Gena, I think it's really difficult to know what will guarantee approval or not. Obviously, it depends on the magnitude of the other results. It depends on safety profile, depends on lots of things. But I think the trial will be considered positive based on our statistical analysis plan of either endpoint is positive, but you'd like to see them at least minimally moving in the same direction.

吉娜，我覺得很難知道什麼能保證獲得批准，什麼不能。顯然，這取決於其他結果的大小。這取決於安全狀況，取決於許多因素。但我認為，根據我們的統計分析計劃，只要任一終點結果為陽性，試驗結果就會被認為是陽性的，但我們希望看到它們至少朝著同一個方向發展。

You'd like to see magnitudes that we think are clinically meaningful. You like to see consistency across the other endpoints. So I think all of those things go into regulators' evaluation of whether a trial not only was statistically significant, but represents a clinically meaningful therapeutic in the field.

您希望看到的是我們認為具有臨床意義的數值。您希望看到與其他端點的一致性。所以我認為所有這些因素都會影響監管機構對一項試驗的評估，以確定該試驗不僅具有統計意義，而且代表了該領域具有臨床意義的治療方法。

Salim Syed, Mizuho.

Salim Syed，瑞穗銀行。

I'll also ask one on ACACIA, just given the amount of attention this trial is receiving. And sorry for the granularity around the p-value here. But Fady, so the ACACIA trial p-value is split, as I understand it, between KCCQ and peak VO2, both at 0.025, so equal. And if one wanted to play devil's advocate for a second here, just curious why is that the better strategy at this point versus what ODYSSEY had, which was weighted to KCCQ at 0.04 and came in with a p-value of 0.06, which was close to hitting and also a better p-value than what we saw with ODYSSEY with the peak VO2 measure.

鑑於此次審判受到的關注度，我也會就 ACACIA 提出一個問題。很抱歉這裡對 p 值的細節描述不夠細緻。但 Fady，據我了解，ACACIA 試驗的 p 值在 KCCQ 和峰值 VO2 之間分配，均為 0.025，相等。如果有人想在這裡扮演反方角色，只是好奇為什麼在這一點上，這種策略比 ODYSSEY 的策略更好？ ODYSSEY 將 KCCQ 的權重設為 0.04，得到的 p 值為 0.06，接近成功，而且 p 值也比我們在 ODYSSEY 的峰值 VO2 測量中看到的要好。

And the trial only needing, again, statically one measure to hit to be successful. And to that point, while the study is still blinded, if you wanted to, could you change the weighting between the 2 endpoints in ACACIA before unblinding the results?

而且，從統計學角度來看，該試驗只需要達到一項指標即可成功。由此可見，雖然該研究仍處於盲法階段，但如果您願意，能否在揭盲結果之前，更改 ACACIA 中兩個終點之間的權重？

Again, I kind of go through the -- what I said earlier is that any positive result is not necessarily a meaningful result. You could -- I think the ODYSSEY trial missed and the KCCQ delta was 2 or 3, I can't remember the exact number, but pretty modest, and I doubt would -- if you consider the magnitude of effect would be that compelling to regulators. So we powered this trial of 0.025 for each based on what we think is a solid clinical effect at KCCQ that's 5 points and with peak VO2's improved by 1.0.

我再說一遍，我之前說過，任何正面的結果都不一定是一個有意義的結果。你可以——我認為 ODYSSEY 試驗失敗了，KCCQ delta 為 2 或 3，我不記得確切的數字了，但相當有限，而且我懷疑——如果你考慮到影響的程度對監管機構來說是否具有那麼大的說服力。因此，我們根據 KCCQ 中 5 分的臨床效果以及峰值 VO2 提高 1.0 的合理性，對每個 0.025 進行了這項試驗。

Now that powering -- the trial is powered at 90% power for each of those magnitudes doesn't mean that the trial is positive only if we reach those magnitudes. The minimum, I guess, positive difference for those endpoints is substantially smaller and gets into the range of where it's probably debatable whether the size of the effect is meaningful or not. So we think we have adequately powered each endpoint.

現在，功率——試驗在每個量級上都以 90% 的功率進行，並不意味著只有當我們達到這些量級時，試驗結果才是積極的。我認為，這些終點的最小正差異要小得多，而且已經進入了一個範圍，在這個範圍內，這種效應的大小是否有意義可能值得商榷。所以我們認為每個終端的供電都足夠了。

We think allocating alpha equally provides us an opportunity to win the best on each endpoint. And at this point, I don't anticipate us making any changes to that.

我們認為平均分配 alpha 值可以讓我們有機會在每個終點都取得最佳成績。目前來看，我預計我們不會對此做出任何改變。

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

This is actually Zaki on for Akash. So just again on Nonobstructive. You've talked about how Bristol's ODYSSEY study had an outlier placebo. And to us, it almost seems like their standard deviation on KCCQ in particular, came in higher than they expected in their protocol. So for ACACIA, you've chosen to keep the trial actually at a similar size of ODYSSEY with an even more aggressive alpha split.

這其實是紮基代替阿卡什上場。所以，再說一遍，不要阻礙。你曾提到布里斯託的 ODYSSEY 研究中存在一個異常的安慰劑組。在我們看來，他們的 KCCQ 標準差似乎比他們預期的要高。所以對於 ACACIA，你們選擇保持試驗規模與 ODYSSEY 相似，但 alpha 分組更加激進。

So I just want to know in terms of what you're seeing on blinded variability, what gives you confidence that, one, you're not underpowered versus ODYSSEY and two, that placebo is actually tracking in line with your expectations around that 5-point placebo-adjusted delta on KCCQ?

所以我想知道，就您在盲法變異性方面所觀察到的情況而言，是什麼讓您確信，第一，您的研究效力不低於 ODYSSEY 研究；第二，安慰劑組的實際表現符合您對 KCCQ 上 5 分安慰劑調整差值的預期？

Well, I think your last point is impossible to answer because we're blinded, so we don't know what the placebo effect is in ACACIA. We do monitor the variability of the combined data set and for now, the variability appears to be within our assumptions. So I think we're adequately powered based on the global variability.

嗯，我認為你最後一個問題無法回答，因為我們被蒙蔽了雙眼，所以我們不知道相思樹中的安慰劑效應是什麼。我們會監測合併資料集的變化情況，目前來看，這種變化似乎在我們的預期範圍內。所以我認為，根據全球變異率，我們的能源供應是充足的。

And again, I'll just say that the variability that we've observed in the KCCQ and several trials that we run using that metric is generally about 15-point range, which tracked with SEQUOIA, it's tracked with other trials we've done in that area. And I think the indication, it's not really any different at this point. So I think we're tracking along our assumptions and for now, we'll just let things play out and see how they read out next year.

我再次強調，我們在 KCCQ 和我們使用該指標進行​​的幾項試驗中觀察到的變異性通常在 15 分左右，這與 SEQUOIA 的結果一致，也與我們在該領域進行的其他試驗的結果一致。我認為，從目前的情況來看，情況並沒有什麼不同。所以我覺得我們目前的發展方向與我們的假設相符，現在，我們就靜觀其變，看看明年結果如何。

I might also underscore that variability is a function of a number of factors, including experience in the course of conduct of studies such as this. And please understand that we believe that one way to manage variability as we have done, is to go to centers with ample experience conducting clinical research using aficamten and as has already been historically validated in our prior studies. So we do believe that's something that serves to our favor.

我還要強調，變異性是多種因素共同作用的結果，包括進行此類研究的經驗。請理解，我們認為管理變異性的一種方法，就像我們一直以來所做的那樣，是前往在aficamten方面擁有豐富臨床研究經驗的中心，這在我們之前的研究中已經得到了歷史驗證。所以我們相信這對我們有利。

Carter Gould, Cantor Fitzgerald.

卡特·古爾德，坎托·菲茨杰拉德。

Maybe I'll give ACACIA a break for a minute. Andrew detailed a lot of metrics that you'll be watching. Which of those metrics are you likely to share with the investment community? And any of those I can get you to commit to today? And do you anticipate blocking third-party prescription data during the launch?

或許我應該暫時放下ACACIA這個計畫。安德魯詳細介紹了許多你需要關注的指標。您最有可能與投資界分享哪些指標？今天我能讓你答應其中任何一項嗎？你們預計在上線期間會封鎖第三方處方資料嗎？

Andrew?

安德魯？

So those three metrics I talked about in terms of prescribing breadth and depth as well as volume of patients is what we plan on sharing. No, we're not going to give targets and share what those would be. Relative to data, this is a very limited distribution the REMS drives that as well. The specialty pharmacies or two of them will not report data. We will report that on a quarterly basis.

因此，我剛才提到的關於處方廣度、深度以及患者數量的這三個指標，正是我們計劃分享的內容。不，我們不會設定目標，也不會透露具體目標是什麼。相對於數據而言，這是一個非常有限的分佈，REMS 也對此有所影響。其中一兩家專科藥局不會上報數據。我們將按季度匯報。

There are also pharmacies that will be qualified IDN pharmacies through large healthcare systems. Many of those will be reported through syndicated data, but that will be a very small portion of our overall volume, maybe around 20% to 30% or so. So if you look at syndicated data from IQVIA or Symphony or one of those sources, you're not going to see anywhere near the complete picture, but we certainly will give that picture on a quarterly basis.

還有一些藥房將透過大型醫療保健系統獲得 IDN 藥房資格。其中許多數據將透過聯合數據進行報道，但這僅占我們總數據量的一小部分，可能在 20% 到 30% 左右。因此，如果您查看 IQVIA 或 Symphony 或類似來源的聯合數據，您將無法看到全貌，但我們肯定會按季度提供全貌。

James Condulis, Stifel.

James Condulis，Stifel。

I'd like to ask one on back to ACACIA and again, on blinded data. I was curious how much of a line of sight do you have on kind of like blinded safety data and maybe what the LVF less than 50% rate looks like? Obviously, not anything specific, but like how it compares to, say, what you saw in SEQUOIA and Obstructive. Just curious if there's any color there.

我想就 ACACIA 以及盲法數據再問一個問題。我很好奇，對於類似盲人安全資料的情況，你的視線範圍有多大？以及LVF低於50%的比例是什麼樣的？顯然，不是指任何特定的東西，而是像它與你在 SEQUOIA 和 Obstructive 中看到的東西相比如何。只是好奇那裡有沒有顏色。

Yes, I'm going to try carefully here. I'll just say that there's nothing out of the blinded data that are unexpected based on what we've seen so far.

是的，我會謹慎行事。我只能說，根據我們目前所看到的，盲測數據中沒有任何出乎意料的結果。

Cory Kasimov, Evercore.

Cory Kasimov，Evercore。

So I want to go back to the pending launch. And I'm curious, do you anticipate the implementation of another REMS program at these HCM clinics where they're already prescribing mavacamten is going to be a barrier that we should expect to kind of slow down the cadence of launch in the early days? Or is the process of registering centers relatively straightforward at this point?

所以我想回到待發布的話題。我很好奇，您是否預計在這些已經開始使用馬伐卡坦的 HCM 診所實施另一個 REMS 計劃，會成為一個障礙，從而在早期階段減緩產品的上市速度？或者說，目前註冊中心的流程是否相對簡單？

So I'll ask Andrew to comment. I might just start by saying we're respectful of the fact that there are existing workflows that have already been adapted. And as Andrew has already highlighted, it's our goal to be enabling a REMS program and implementation that should create for a more flexible and easy experience for physicians, patients and pharmacists within established workflows. Maybe Andrew can elaborate.

所以我請安德魯發表一下意見。首先我想說的是，我們尊重已經存在並加以調整的現有工作流程。正如 Andrew 已經強調的那樣，我們的目標是推動 REMS 計劃的實施，從而在既定的工作流程中為醫生、患者和藥劑師創造更靈活便捷的體驗。或許安德魯可以詳細說明一下。

Yes, it's a good question. There's a lot of centers that physicians who are writing today. So part of the goal would be for a differentiated REMS program alongside MAPLE, alongside SEQUOIA to these get more over the line, so to speak, to prescribing. So that would be new workflow for them. Those who have existing workflow.

是的，這是個好問題。現在有很多醫師在撰寫文章。因此，部分目標是製定一個與 MAPLE 和 SEQUOIA 不同的 REMS 計劃，以便這些計劃能夠更有效地進行處方。那對他們來說將是一種新的工作流程。那些已經擁有現有工作流程的人。

The workflow in the office really is around echo for titration and monitoring. That is similar. So you're going to have echo monitoring potentially with, say, a different frequency or the ability to titrate up at each point of monitoring. So it's the same kind of workflow, if you will. So we're not anticipating that the workflow around monitoring or the window for monitoring will cause must act, especially among high users and high centers.

辦公室的工作流程其實是圍繞著滴定和監測的迴聲進行。那是類似的。所以，你可以進行迴聲監測，例如，採用不同的頻率，或是能夠在每次監測時進行頻率遞增。所以，從某種意義上來說，工作流程是一樣的。因此，我們預期監控工作流程或監控視窗不會導致必須採取行動，尤其是在高用戶和高中心。

So we are expecting that a differentiated REMS, the differentiated label and an overall profile will drive differentiated use when physicians certainly understand that. So that's the way we've been thinking about it.

因此，我們預計，當醫生們真正理解差異化的風險評估和緩解策略 (REMS)、差異化的標籤和整體概況時，將會推動差異化的使用。這就是我們一直以來的想法。

Tess Romero, JPMorgan.

Tess Romero，摩根大通。

This is Caroline Pocher on for Tess Romero with JPMorgan. Just one from us on aficamten and oHCM. So acknowledging that the late cycle meeting took place on September 15, can you just comment on if the REMS has been finalized yet at this point in the review process? And if not, what are the remaining items of the REMS that need to be finalized? And when would you expect this to be completed?

這裡是摩根大通的卡洛琳·波切爾，為您代班特絲·羅梅羅。我們只對 aficamten 和 oHCM 發表了一篇文章。鑑於後期週期會議已於 9 月 15 日舉行，您能否就審查過程的這個階段，REMS 是否已經最終確定發表評論？如果以上條件都已滿足，那麼 REMS 中還有哪些項目需要最終確定？您預計何時能夠完成？

So we're continuing with interactions with FDA, and we have not finalized those matters. We do anticipate that we're making progress towards enablement of finalization of those in order to meet the PDUFA date. With that said, we've had exchanges and interactions -- and as I've indicated previously, we don't believe that we're engaging around framework, but rather some operational details, things that speak more to things like web pages and that which is administrative.

因此，我們仍在與FDA進行溝通，但尚未最終確定這些事項。我們預計，在完成這些工作方面，我們將取得進展，以滿足 PDUFA 的截止日期。話雖如此，我們之間還是進行了一些交流和互動——正如我之前所指出的，我們認為我們之間的互動不是圍繞框架展開，而是圍繞一些操作細節展開，這些細節更多地與網頁和管理方面有關。

Those are things that we think should come together to be enabling of FDA to review this and hopefully approve it in time for the PDUFA date.

我們認為這些因素應該能夠共同促成 FDA 對該藥物進行審查，並預計在 PDUFA 日期前及時批准該藥物。

Maxwell Skor, Morgan Stanley.

麥克斯韋‧斯科爾，摩根士丹利。

One more on ACACIA. Could you just confirm whether there are any shared trial sites between ODYSSEY and ACACIA, approximately how many -- the percentage overlap? And if so, what potential impact that might have on, let's say, a placebo response or other factors relevant to interpreting ACACIA results?

再來一篇關於相思樹的文章。能否確認一下 ODYSSEY 和 ACACIA 之間是否有任何共享的試驗地點，大約有多少個——重疊百分比是多少？如果真是如此，那麼這可能會對安慰劑效應或其他與解釋 ACACIA 結果相關的因素產生什麼潛在影響呢？

Max, I can't give you the exact overlap, but the overlap is not very large. Obviously, sites were conducting two trials that were simultaneously in the same patients, it would be a bit problematic. Some trials have finished their commitment and obviously and then became a case of sites later and things. But the overlap, I don't think is very large.

Max，我無法給出確切的重疊部分，但重疊部分並不大。顯然，如果兩個試驗點同時對同一批患者進行兩項試驗，那就會有點問題。有些試驗已經完成了他們的承諾，顯然，然後就變成了後來的網站等等問題。但我認為重疊部分並不大。

We ended up generally going to sites that we already had experience with or have visited ourselves, either our HCM team or clinical operations group. And so we ended up choosing a cadre of sites in South America, Europe, North America, Australia, China, Israel that represented either our own prior experience or had -- clearly had experience in other HCM trials.

最後我們通常會去我們已經有過經驗或親自去過的地方，要嘛是我們的 HCM 團隊，要嘛是臨床營運團隊。因此，我們最終選擇了南美洲、歐洲、北美洲、澳大利亞、中國、以色列的一系列試驗點，這些試驗點要么代表了我們自己之前的經驗，要么顯然在其他 HCM 試驗中擁有經驗。

Yasmeen Rahimi, Piper Sandler.

亞斯敏·拉希米，派珀·桑德勒。

Maybe a question for Andrew. You did such a nice job outlining your commercial strategy. How are you thinking about pricing? It sounded like you're thinking about pricing and parity to mavacamten. Obviously, given the product profile, you may have flexibility to go higher. So I appreciate any color around that.

或許可以問問安德魯。你對商業策略的闡述非常出色。你們是如何考慮定價的？聽起來你好像在考慮定價以及與 mavacamten 的對等性。顯然，考慮到產品特性，價格可能會更高。所以我很欣賞圍繞這個主題的任何色彩。

Sure. So we'll communicate our price what it's set. But I think you can think about when a second product comes out or a category that's already been priced is typically priced in proximity to the initial product. So I would think we're going to be in that same kind of ballpark, plus or minus maybe a small percentage, but we're certainly going to be in that range.

當然。所以我們會把價格定好後再通知大家。但我認為你可以想想，當第二個產品推出時，或者當一個類別的產品已經定價時，其定價通常會與第一個產品的價格相近。所以我認為我們的結果應該會在這個範圍內，上下浮動可能很小，但肯定會在這個範圍內。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

So a quick follow-up of the aficamten potential US launch. Could you share more details about what you expect in terms of time to conversion to commercial drug, patient compliance over time? And anything you're hearing or learning about the possible rate in which early adopters could prescribe aficamten?

因此，我們快速跟進一下 aficamten 在美國的潛在上市。您能否詳細說明一下，您預計從研發到商業化藥物上市需要多長時間，以及病患的長期依從性如何？您是否聽過或了解到早期使用者可能開立阿菲卡坦處方的頻率？

Sure. So thanks for the question. So in terms of conversion, in the beginning, we'll have blocks as payers go through reviews, medical exception is certainly the path that, that will go through. Medical exception can be as fast as, say, two to three weeks or it could take 90 days. So it depends on the plan, depends on the doctor's office, the documentation and if it's in compliance with what the plan wants.

當然。謝謝你的提問。所以就轉換率而言，一開始，由於付款方需要審核，我們會遇到一些障礙，醫療例外肯定是其中一條途徑。醫療豁免可能只需兩到三週，也可能需要 90 天。所以這取決於醫保計劃、醫生辦公室、相關文件以及是否符合醫療保險計劃的要求。

But I think you can think in that time frame, we're going to have the patient support programs where we can have them for commercial patients to bridge them through that process. Medicare patients, of course, we can't do that. We'll provide free drug for those that are appropriate for patient assistance. And so that's how I would think about time to conversion until we have more broader access.

但我認為，在這個時間範圍內，我們將推出患者支援計劃，為商業患者提供幫助，以幫助他們度過這個過程。當然，對於聯邦醫療保險患者，我們不能這麼做。我們將為符合患者援助資格的人提供免費藥物。所以，這就是我對轉換所需時間的理解，直到我們擁有更廣泛的存取權限。

In terms of compliance, we are seeing that at least in this category, compliance and persistency is higher than you see for other cardiovascular drug. I'm guessing likely because of the time frame it takes to get our drug, the commitment of going through echos and the like that you're going to see compliance after two years probably still be above 50% or so.

就依從性而言，我們看到至少在這個類別中，依從性和持續性高於其他心血管藥物。我猜想，可能是因為獲得我們的藥物需要時間，以及需要進行心臟超音波檢查等一系列檢查，所以兩年後的依從性可能仍然會高於 50% 左右。

And then your third question was -- can you remind me?

然後你的第三個問題是──你能提醒我嗎？

Yes. The last part was about early adopter physicians prescribing aficamten out of the gate.

是的。最後一部分是關於早期採用者醫生一開始就開立阿菲卡坦處方的。

Yes. So this is a very, very focused market, 650 prescribers or so, about 80% of the market. Those prescribers, we know well. We've actually been interacting with many of them already. We will call on the vast majority, if not all of them in the first few weeks of launch. When you think about those high users, if you will, when we've done even most -- market research even in the last month or so, MAPLE with SEQUOIA increases their urgency to treat.

是的。所以這是一個非常非常集中的市場，大約有 650 位處方醫生，約佔市場份額的 80%。我們對那些開處方的人都很熟悉。我們其實已經和他們中的許多人有過交流了。在產品發布後的最初幾週內，我們將聯繫絕大多數人，甚至可能全部。當你想到那些高頻用戶時，即使我們在過去一個月左右的時間裡進行了大量的市場調查，MAPLE 與 SEQUOIA 的結合也增加了他們治療的緊迫性。

So we're expecting to get high use, if you will, relative to other physicians in those physicians that were early adopters for CMIs, we should see the same for aficamten if it gets approved. So that's our expectation.

因此，我們預計，與其他醫生相比，Aficamten 的使用率將會很高。對於那些早期採用 CMI 的醫生來說，如果 Aficamten 獲得批准，我們應該會看到相同的情況。這就是我們的預期。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

Productive third quarter. Would love to hear your thoughts maybe for Andrew on what your latest thinking is on peak CMI drug penetration. Maybe if you can also comment on where it stands now and your expectation of scenarios where it could land in the kind of near-term, one to two years. And like you said about your impact of the MAPLE-HCM data, but also a lot of real-world data coming from your peers, including at AHA. I

第三季成果豐碩。很想聽聽你對CMI藥物滲透峰值的看法，也許可以轉達給Andrew。如果您還能就它目前的狀況以及您對它在近期（一到兩年）可能的發展前景的預期發表一些評論，那就更好了。正如你所說，MAPLE-HCM 數據的影響，以及來自同行（包括 AHA）的大量真實世界數據的影響。我

f you could maybe comment on that, that would be helpful. And a subpart question was around some of the patient navigator training that you're doing that happens around when you have a label in hand. I was just curious if any key FAQs or pushbacks you're preparing for would also be helpful to get color on.

如果您能就此發表一些意見，那就太好了。其中一個子問題是關於你正在進行的一些患者導航員培訓，這些培訓通常是在你手裡拿著標籤的時候進行的。我只是好奇，如果您準備了一些關鍵的常見問題或反對意見，能否也提供一些細節資訊？

So a lot of questions there, so I'll try to address those. CMI penetration, I think, was your first question. Right now, the penetration is probably in the 15% to 20% range of oHCM, and I'm defining that as the number of eligible patients, those that are Class II, Class III, those that are treated with the CMI. So we are expecting, as we said all along, around 80% or so of the market to be available, meaning patients who are eligible, but not currently on a CMI.

所以有很多問題，我會盡量一一解答。我認為，CMI滲透率是你的第一個問題。目前，oHCM 的滲透率可能在 15% 到 20% 之間，我將其定義為符合條件的患者人數，即 II 類、III 類患者，即接受 CMI 治療的患者人數。因此，正如我們一直以來所說，我們預計大約 80% 的市場份額將會開放，這意味著符合條件但目前尚未接受 CMI 治療的患者。

The expectation is that, that probably penetration probably increases in the -- around 5 percentage points each year. So when you look at real-world evidence when you look at additional trials, that certainly will increase penetration. If guidelines are impacted, if MAPLE helps influence guidelines in '26 or '27, that certainly will accelerate penetration.

預計滲透率可能會以每年約 5 個百分點的速度成長。所以，當你查看現實世界的證據，當你查看更多的試驗時，這肯定會提高滲透率。如果指南受到影響，如果 MAPLE 有助於影響 2026 年或 2027 年的指南，那肯定會加速滲透。

So I think there's things that can change the trajectory of penetration, but that's where it is now. In terms of training, we did provide the label to the FDA. We've had a few rounds of feedback. I think that we've alluded to. I think we can certainly train on a draft label and then we'll train again on the final. That's pretty typical around how you would train relative to a label and relative to a REMS.

所以我認為有些因素可以改變滲透率的軌跡，但目前情況就是如此。在培訓方面，我們確實向F​​DA提供了標籤。我們已經收到幾輪回饋意見了。我想我們已經暗示過了。我認為我們當然可以先用草稿標籤進行訓練，然後再用最終標籤來訓練。這和你如何根據標籤和 REMS 進行訓練是很典型的。

Joe Pantginis, H.C. Wainwright.

喬·潘特吉尼斯，H.C. 溫賴特。

So curious, just totally switching gears here to omecamtiv mecarbil. Right now, the guidance is moving enrollment continuing into 2026. When do you anticipate providing more visibility as to sites, enrollment numbers? And what levels of clarity can we get, do you think, starting in '26?

真好奇，我突然完全轉而討論 omecamtiv mecarbil 了。目前，指導方針將招生工作推遲到 2026 年。您預計何時能更清楚地展示網站位置和招生人數？那麼，你認為從 2026 年開始，我們能獲得怎樣的清晰度呢？

We'll ask Stuart maybe to take that, please.

我們或許可以請史都華幫忙拿一下。

As I mentioned, we are making good progress in terms of site activation. We have 75% of sites activated in North America and Europe. And we're seeing screening picking up, randomization picking up. And I mean we're sort of not at a point where we can sort of start providing those numbers because I think we're going to hold off on that until we have all the sites activated and we have a good trajectory.

正如我之前提到的，我們在網站激活方面取得了良好進展。我們在北美和歐洲已啟動 75% 的網站。我們看到篩檢工作正在增加，隨機分組也在增加。我的意思是，我們目前還無法提供這些數字，因為我認為我們會等到所有站點都已啟用且發展勢頭良好後再公佈這些數據。

But so far, so good. Study conduct is going well and so with site interaction and screening.

但目前為止，一切順利。研究進行進展順利，現場互動篩選工作也進展順利。

So Joe, I think as we roll into the new year and have a better sense of how these new sites that have been activated are enrolling, we should be able to tighten some of that guidance to the expectation of when we might complete enrollment. And then from there, as you know, this is a study that's accruing events. It's event-driven, and we can maybe point more generally to when we might expect data.

所以喬，我認為隨著我們進入新的一年，並且對這些已啟動的新網站的註冊情況有更清晰的了解，我們應該能夠收緊一些指導方針，以更好地預測我們何時能夠完成註冊。然後，正如你所知，這是一項不斷累積事件的研究。它是事件驅動的，我們或許可以更籠統地指出我們何時可能會收到資料。

Paul Choi, Goldman Sachs.

Paul Choi，高盛。

I want to ask on your partnered CAMELLIA trial and just if you can provide any updates on timing on that and just sort of maybe help us think about when your partner might be able to launch in Japan and just sort of what would be a reasonable assumption there? And then on the AMBER trial study for HFpEF, would you be in a position to potentially present some initial data on that in 2026?

我想問一下您與合作夥伴進行的 CAMELLIA 試驗，您能否提供一些關於時間安排的最新信息，並幫助我們思考您的合作夥伴何時可能在日本推出該產品，以及合理的預期是什麼？那麼關於針對 HFpEF 的 AMBER 試驗研究，您能否在 2026 年公佈一些初步數據？

I'll ask Fady to tackle those, please.

我會請法迪處理這些問題。

Yes. I mean with regards to the progress of the oHCM trial in Japan, I mean, the strategy in Japan will be a little bit tied more to completion both of ACACIA and CAMELLIA. We expect them really to kind of complete in a similar time frame and both leading to regulatory interactions and ultimately approval there.

是的。我的意思是，就日本的 oHCM 試驗進展而言，日本的策略將更多地與 ACACIA 和 CAMELLIA 兩項試驗的完成情況相關。我們預計它們將在相近的時間範圍內完成，並最終都會與監管機構進行溝通，並獲得批准。

So I can't really give you specifics yet in terms of where it is, but CAMELLIA is moving along within line of that expectation. And then AMBER, I think we're still a little too early for us to commit to data in 2026. We should be able to say more about that probably at our next earnings call.

所以，就目前的情況而言，我還不能給出具體的消息，但 CAMELLIA 的進展符合預期。至於 AMBER，我認為我們現在就承諾在 2026 年獲得數據還為時過早。我們或許能在下次財報電話會議上詳細說明這一點。

Serge Belanger, Needham.

Serge Belanger，尼德姆。

This is John Gionco on for Serge today. So with the results of MAPLE now in the public domain, curious what your time lines look like in terms of how quickly you'd like to file the sNDA to incorporate that data into API label and whether you think having it in the label will alter in any way prescribing habits for treating physicians?

今天就由約翰·吉翁科代替塞爾吉為您報道。既然 MAPLE 研究結果已經公開，我很好奇你們的計畫時間表是怎樣的，你們打算多快提交補充新藥申請 (sNDA) 將這些數據納入原料藥標籤？你們認為將這些數據納入標籤是否會以任何方式改變醫生的處方習慣？

So I'll take the first part and ask Andrew to address the second part. But our goal is if we see aficamten approved based on the SEQUOIA results by the end of this year that we're moving very swiftly to submitting a supplemental NDA based on MAPLE data promptly in early 2026 to be enabling of a potential expanded label even possibly by the end of 2026. Andrew can comment on how that may factor into expanded use.

所以我先回答第一部分，第二部分請安德魯來解答。但我們的目標是，如果今年年底前根據 SEQUOIA 的結果，aficamten 獲得批准，我們將迅速根據 MALE 數據在 2026 年初提交補充 NDA，以便有可能在 2026 年底前獲得擴大適應症的批准。Andrew可以就這可能如何影響其更廣泛的應用發表一些看法。

We've tested this several times, including most recently this quarter. Each time we get a top line increased use of CMI, so CMI penetration goes up and increased brand share for aficamten or preferential share, if you will. So a larger market, larger share of that market. When you segment it, those that are kind of the core users, they're basically saying it's confirmatory of safety and efficacy, and that gives them even more reason in belief.

我們已經多次測試過，包括本季最近一次。每次我們獲得更高的 CMI 使用率，CMI 滲透率就會上升，aficamten 的品牌份額或優先份額也會增加。因此，更大的市場，更大的市場份額。當你進行細分時，那些核心使用者基本上都表示，這證實了產品的安全性和有效性，這讓他們更相信產品。

When you look at those that are heavy beta blocker, it really challenges their belief in the efficacy of beta blockers. It increases their urgency to treat or urgency to refer I think that second group is going to take a little longer, some of them and guidelines as well as continued education and promotion will certainly continue to move those.

當你觀察那些大量服用β受體阻斷劑的人時，你會發現他們對β受體阻斷劑療效的信念受到了真正的挑戰。這會提高他們治療或轉診的緊迫性。我認為第二組患者需要更長的時間才能得到治療，而指導方針以及持續的教育和推廣肯定會繼續推動這些患者的康復。

So at a high level, we're expecting a larger market, a larger share, and we're certainly seeing this as one of the expansion strategies we've talked about in terms of a bigger market.

因此，從宏觀層面來看，我們預期市場規模會更大，市場佔有率會更大，而且我們當然也把這視為我們討論過的擴大市場規模的擴張策略之一。

Kripa Devarakonda, Truist Securities.

Kripa Devarakonda，Truist 證券公司。

[Alex] on for Kripa. Based on your updated late cycle meeting with the FDA and the nature of the day 120 List of Questions for the CHMP, is there anything we should be aware of to indicate that the REMS requirement could possibly be meaningfully different from the US and EU?

[亞歷克斯] 接替 Kripa。根據您與 FDA 的最新後期週期會議以及 CHMP 第 120 天問題清單的性質，我們是否應該注意任何表明 REMS 要求可能與美國和歐盟有實質差異的情況？

Well, there is no REMS requirement in the EU. That's all handled through labeling, as you know. But I do think that to your question, we're expecting that aficamten, if approved in the US and in the EU will be addressed similarly in terms of risk mitigation.

歐盟沒有風險評估和緩解策略（REMS）的要求。如你所知，這一切都是透過標籤來實現的。但我認為，就你的問題而言，我們預計如果 aficamten 在美國和歐盟獲得批准，那麼在風險緩解方面將會採取類似的措施。

Jason Zemansky, Bank of America.

傑森‧澤曼斯基，美國銀行。

Congrats on the progress. Maybe just to switch gears, but in light of your recent balance sheet updates, where do you stand in terms of your ability to support both the US and EU launches? I mean, do you foresee any need for additional capital, especially given your expectations for the launch?

恭喜你取得進展。或許可以換個話題，但鑑於您最近的資產負債表更新，您在支持美國和歐盟市場發布方面的能力如何？我的意思是，考慮到您對產品上市的預期，您是否預見到需要額外的資金？

Jason, this is Sung. Thanks for the question. We can't rule out future financing. But with that said, we expect to finish the year with $2.2 billion in cash and investments I'm sorry. $1.2 billion Thank you. I got a little excited there. So that puts us in a very strong position, not only to launch aficamten in the US, but also to continue to build out in the EU and importantly, to continue to advance our pipeline.

傑森，我是宋。謝謝你的提問。我們不能排除未來融資的可能性。但即便如此，我們預計年底現金及投資總額將達22億美元。抱歉，是12億美元。謝謝。我當時有點激動了。因此，這使我們處於非常有利的地位，不僅可以在美國推出 aficamten，還可以繼續在歐盟發展，更重要的是，可以繼續推動我們的產品線。

Keep in mind that we do have access to further capital potentially up to $175 million. This is from the Tranche 7 loan from Royalty Pharma. So we'll continuously weigh our options in terms of capital requirements and capital structure.

請記住，我們還有可能獲得更多資金，最高可達 1.75 億美元。這是來自 Royalty Pharma 的第七期貸款。因此，我們將持續權衡各種方案，包括資金需求和資本結構。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

This is [Natalie] on for Ash. This is Natalie on for Ash Verma at UBS. So we just had a quick question on nHCM. Now I know there's a lot of discussion about the heterogeneity of this patient population. Have you guys been able to identify if there is a specific set of patients that see the most benefit from CMI?

這是娜塔莉替補阿什上場。這裡是娜塔莉，替阿什·維爾瑪在瑞銀為您報道。我們剛才有個關於nHCM的簡短問題。我知道現在有很多關於該患者群體異質性的討論。你們是否已經確定是否存在特定類型的患者群體能從 CMI 中獲益最多？

Well, I would say that, that question remains unanswered, maybe perhaps we will require both analyses of the ODYSSEY data, the ACACIA data when they come out. We think enrolling patients that are symptomatic, that have classic HCM -- classic HCM phenotype as evident on echocardiography that have certain biomarker increases.

嗯，我認為這個問題仍然沒有答案，或許我們需要對 ODYSSEY 數據和 ACACIA 數據進行分析，等它們公佈後再做解答。我們認為應該招募有症狀、具有典型 HCM 表型（如超音波心動圖所示）且某些生物標記升高的患者。

I think all of those things talk about a symptomatic, highly symptomatic and functionally limited patient population. And based on our prior experience in REDWOOD, we think that population should be responsive to aficamten. So I think we'll have more to say when we see the ACACIA data in next year.

我認為所有這些都表明患者群體存在症狀、症狀嚴重和功能受限的情況。根據我們在 REDWOOD 的先前經驗，我們認為人口應該會對 aficamten 做出反應。所以我覺得等到明年看到 ACACIA 數據的時候，我們會有更多話要說。

I think I would add that we've been following a cohort of Nonobstructive patients for over two years now. And the large majority of them are responding well symptomatically and based on cardiac biomarker improvement. So I think what we're observing so far, at least in this cohort in FOREST is a pretty general improvement in response to treatment.

我想補充一點，我們已經對一組非阻塞性患者進行了兩年多的追蹤。絕大多數患者的症狀都有改善，心臟生物標記也有所改善。所以我認為，至少在 FOREST 研究的這一組患者中，我們目前觀察到的現像是治療反應普遍有所改善。

And thank you, ladies and gentlemen. That was our final question from our audience today. Mr. Blum, I'm happy to turn it back to you for any additional or closing remarks you have.

謝謝各位女士、先生。這是今天觀眾提出的最後一個問題。布魯姆先生，我很樂意把發言權交還給您，請您再補充或作總結發言。

Thank you. I want to thank all of our participants on the call today. I want to thank you for your continued support as well as your interest in Cytokinetics. This will conclude our Q3 earnings call. And my hope is that next time we convene in one of these earnings calls, we'll talk about what could be the first potential approval for aficamten and a product arising out of our long-standing research and development, a very important milestone for our company and all of our stakeholders, including our shareholders.

謝謝。我要感謝今天所有參加電話會議的人員。感謝您一直以來的支持以及對細胞動力學的關注。我們的第三季財報電話會議到此結束。我希望下次我們召開財報電話會議時，能夠討論 aficamten 的首次潛在批准，這是我們長期研發的成果，對我們公司和所有利益相關者（包括我們的股東）來說，都是一個非常重要的里程碑。

With that, operator, we can now conclude the call.

接線員，通話到此結束。

Thank you. And ladies and gentlemen, thank you for joining today's Cytokinetics Q3 2025 Earnings Call. You may now disconnect your lines.

謝謝。女士們、先生們，感謝各位參加今天Cytokinetics 2025年第三季財報電話會議。現在您可以斷開線路了。