莫德納 (MRNA) 2026 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to Moderna's third quarter 2026 conference call. (Operator Instructions) Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.

大家好，感謝各位稍候。歡迎參加莫德納（Moderna）2026 年第三季電話法說會。(接線員指示) 請注意，今天的會議將被錄音。現在我想把會議交給今天的發言人 Lavina Talukdar。請開始。

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's third quarter 2026 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investors section of our website.

謝謝你，Kevin。各位早安，感謝各位參加今天的電話會議，一同討論莫德納 2026 年第三季財務結果與業務更新。您可前往我們網站的投資人專區，取得今天早上發布的新聞稿以及我們將要檢視的簡報投影片。

On today's call are Stephane Bancel, our Chief Executive Officer; Stephen Hoge, our President; Jamey Mock, our Chief Financial Officer; and David Berman, our Chief Development Officer.

今天與會者包括：我們的執行長 Stephane Bancel；總裁 Stephen Hoge；財務長 Jamey Mock；以及研發長 David Berman。

Before we begin, please note that this call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

在開始之前，請注意本次電話會議將包含依據 1995 年《私人證券訴訟改革法》（Private Securities Litigation Reform Act of 1995）安全港條款所作的前瞻性陳述。

Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

請參閱隨附簡報的第 2 頁以及我們向美國證券交易委員會（SEC）提交的文件，其中載有重要風險因素，可能導致我們的實際表現與結果與這些前瞻性陳述所明示或暗示者出現重大差異。

With that, I will turn the call over to Stephane.

接下來，我把電話交給 Stephane。

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start today with a review of our third quarter. Jamey will then cover our financial results and outlook, followed by Stephen with our current business updates in infectious disease.

謝謝你，Lavina。各位早安或午安。感謝各位加入我們。我今天將先回顧我們的第三季表現。接著 Jamey 將說明我們的財務結果與展望，之後 Stephen 將就傳染病領域的最新業務進展進行更新。

David will then review our clinical progress in oncology and rare diseases. And I will come back quickly for close on our key value drivers before Q&A. The Moderna team delivered a great third quarter, generating $1.3 billion in revenues, representing 29% growth year-over-year.

接著 David 將回顧我們在腫瘤與罕見疾病方面的臨床進展。然後在問答之前，我會簡短回來總結我們的關鍵價值驅動因素。莫德納團隊在第三季交出亮眼成績，營收達 13 億美元，年增 29%。

Importantly, this strong commercial performance translated into $200 million in net income for the quarter. We also ended the quarter with a strong balance sheet with $8 billion in cash and investments, reflecting a combination of solid operational and commercial execution, along with a highly successful convertible debt financing.

更重要的是，這項強勁的商業表現轉化為本季 2 億美元的淨利。我們也在季末維持強健的資產負債表，現金與投資合計 80 億美元，反映出穩健的營運與商業執行，以及一筆非常成功的可轉換公司債融資。

And we continue to demonstrate financial discipline across the company, reducing cash cost by 10% compared to the third quarter of last year. Together, these strong results underscore our ability to deliver strong commercial performance while maintaining financial discipline and strengthening our financial position.

我們也持續在全公司展現財務紀律，現金成本較去年第三季降低 10%。綜合而言，這些強勁結果凸顯我們在維持財務紀律並強化財務體質的同時，仍能交出優異的商業表現。

During the quarter, we achieved several important milestones across our pipeline and our business. US FDA approval of mFLUSIVA, making Moderna's fifth approved product and the first mRNA-based influenza vaccine to reach the market. In Canada, we secured approvals of both mFLUSIVA and mCOFLU yesterday, the local brand name for mCOMBRIAX, further expanding our respiratory portfolio internationally.

本季我們在產品線與業務方面達成多項重要里程碑。美國 FDA 核准 mFLUSIVA，使其成為莫德納第 5 項獲核准產品，也是首款上市的 mRNA 流感疫苗。在加拿大，我們於昨日取得 mFLUSIVA 與 mCOFLU 的核准；mCOFLU 為 mCOMBRIAX 的當地品牌名稱，進一步在國際市場擴展我們的呼吸道產品組合。

In oncology, we are very proud to present positive Phase III data for intismeran autogene, our individualized cancer therapy being developed in partnership with Merck.

在腫瘤領域，我們非常自豪地公布 intismeran autogene 的第三期（Phase III）正向數據；這是我們與默克（Merck）合作開發的個人化癌症治療。

The results demonstrated a significant clinical benefit with a 42% reduction in the risk of recurrence or death in patients with resected melanoma, and additional analysis suggesting an even greater benefit of 49% reduction in the risk of recurrence or death in patients who received at least one dose of intismeran as planned.

結果顯示具顯著臨床效益：在已切除黑色素瘤患者中，復發或死亡風險降低 42%；另有進一步分析顯示，對於依計畫至少接受一劑 intismeran 的患者，復發或死亡風險降低幅度更高，達 49%。

Importantly, this marks the first combination immunotherapy regimen to demonstrate additional benefits of a KEYTRUDA alone in the adjuvant melanoma setting, representing a significant milestone for melanoma patients and their families around the world. David will discuss these results in greater details.

重要的是，這標誌著首個在輔助治療（adjuvant）黑色素瘤情境中，證實相較單用 KEYTRUDA 仍可帶來額外效益的免疫治療合併療法，對全球黑色素瘤患者及其家屬而言是一項重大里程碑。David 將更詳細說明這些結果。

We also took an important step to further strengthen our financial position. During the quarter, we raised $3 billion for a 0% convertible note debt, securing long-term capital on highly attractive terms.

我們也採取重要一步以進一步強化財務狀況。本季我們以 0% 利率可轉換公司債籌資 30 億美元，以極具吸引力的條件取得長期資金。

After accounting for the purchase of capped call, designed to mitigate potential future dilution and fees, we raised approximately $2.6 billion in net proceeds. This financing strengthens our ability to invest in the growth of our oncology business, a key strategic priority for Moderna as we approach candidate important clinical milestones.

在扣除用於降低未來潛在稀釋影響的 capped call（上限買權）購買成本及相關費用後，我們取得約 26 億美元的淨募資款。此項融資強化我們投資腫瘤業務成長的能力；隨著多項候選產品接近重要臨床里程碑，腫瘤業務是莫德納的關鍵策略優先事項。

In Global Health, our Ebola vaccine candidate, mRNA-1469, developed in collaboration with CEPI, was selected to advance into a [Phase II/III] following a recommendation from the WHO Technical Advisory Group.

在全球健康方面，我們與 CEPI 合作開發的伊波拉疫苗候選產品 mRNA-1469，依據 WHO 技術諮詢小組的建議，獲選推進至 [第二/三期]（Phase II/III）試驗。

I am extremely proud of our performance delivered by the team in Q3. Strong sales growth, profitability, approval and quick launch of flu in the US, intismeran positive Phase III and the convertible debt financing. I'm also very pleased and happy to welcome back Juan Andres to Moderna Executive Committee.

我對團隊在第三季交出的表現感到無比自豪：強勁的銷售成長、獲利表現、流感疫苗在美國獲核准並迅速上市、intismeran 第三期正向結果，以及可轉債融資。我也非常高興並歡迎 Juan Andres 回歸莫德納執行委員會。

Many of you will remember Juan for his previous time at Moderna, where he played a critical role in building and scaling our global manufacturing network during the pandemic. He also led the scale-out of individualized manufacturing for intismeran autogene. He knows our company, our technology and our culture extremely well.

許多人都記得 Juan 先前在莫德納任職期間，在疫情期間他在建立並擴大全球製造網絡方面扮演關鍵角色。他也領導了 intismeran autogene 的個人化製造擴產。他對我們公司、技術與文化都非常熟悉。

As we enter this next phase of Moderna's growth with an expanded commercial portfolio and important opportunities ahead in oncology, having Juan back on the team will be invaluable. I am personally very excited to be working with him again. And I know the entire Moderna team is delighted to welcome him back.

隨著我們以更完整的商業化產品組合進入莫德納成長的下一階段，且腫瘤領域仍有重要機會在前，Juan 回到團隊將極具價值。我個人非常期待再次與他共事。我也知道整個莫德納團隊都很高興歡迎他回歸。

With that, I'll turn to Jamey.

接下來，我把時間交給 Jamey。

Thanks, Stephane, and hello, everyone. Today I'll begin with a review of our third quarter financial performance, followed by an update on our 2026 financial framework. Let me start with our commercial performance on slide 8.

謝謝你，Stephane，各位好。今天我將先回顧第三季財務表現，接著更新我們 2026 年的財務框架。我先從第 8 頁的商業表現開始。

We delivered a strong third quarter with revenue of $1.3 billion, bringing our year-to-date revenue to $1.8 billion. Our geographic mix for the quarter was approximately 60% US and 40% international. Both the US and international markets delivered stronger-than-expected revenue in 3Q, driven by a mix of increased demand, operational execution and timing of shipments between the third and fourth quarters.

我們第三季表現強勁，營收 13 億美元，使年初至今營收達 18 億美元。本季地區組合約為美國 60%、國際市場 40%。美國與國際市場在第三季的營收均優於預期，主要受需求增加、營運執行，以及第三季與第四季之間出貨時點安排的綜合影響所帶動。

As mentioned in prior calls, we forecasted two primary growth drivers in 2026: increased mNEXSPIKE adoption and growth in our strategic partnerships in the UK, Canada and Australia. In the US, while the vaccination season is still ongoing, we have seen increased uptake of mNEXSPIKE, and vaccination rates have been relatively stable versus the prior year.

如同先前電話會議所提及，我們預期 2026 年有兩項主要成長動能：mNEXSPIKE 採用率提升，以及我們在英國、加拿大與澳洲的策略合作夥伴關係成長。在美國，雖然接種季仍在進行中，我們已看到 mNEXSPIKE 的接種量提升，而整體接種率相較前一年大致維持穩定。

Internationally, our teams have executed well, particularly in the UK and Canada. Year-to-date, international revenue of $900 million is already $200 million ahead of the full year we delivered in 2025.

在國際市場方面，我們的團隊執行表現良好，尤其是在英國與加拿大。年初至今，國際營收 9 億美元，已較我們 2025 年全年達成的水準高出 2 億美元。

Based on the strong start to the season combined with the visibility we have into the fourth quarter, we are increasing our full year revenue framework to a range of 15% to 25% growth, which exceeds our prior framework of up to 10% growth. We continue to expect an approximately even split between US and international revenue for the full year.

基於本季強勁的開局，加上我們對第四季的可見度，我們將全年營收框架上調至成長15%至25%的區間，超過先前最高成長10%的框架。我們仍預期全年美國與國際營收大致各占一半。

Now let me turn to our third quarter financial performance on slide 9. As I just mentioned, total revenue was $1.3 billion for the quarter, up 29% from last year, primarily driven by higher COVID sales.

現在讓我在第9頁投影片說明我們第三季的財務表現。如我剛才提到，本季總營收為13億美元，較去年成長29%，主要由較高的COVID銷售所帶動。

Cost of sales for the quarter was $318 million, representing 24% of total revenue for the quarter. This was a 54% increase in our cost of sales from Q3 last year, primarily driven by higher product sales volume and other manufacturing-related costs. We remain on track to drive significant gross margin improvements in 2026, excluding the $900 million litigation charge.

本季銷貨成本為3.18億美元，占本季總營收的24%。相較去年第三季，我們的銷貨成本增加54%，主要由較高的產品銷售量及其他製造相關成本所驅動。在排除9億美元訴訟費用後，我們仍按計畫在2026年推動顯著的毛利率改善。

R&D expenses for the quarter were $583 million, down 27% from last year, driven by completion and wind-down of studies in our infectious disease portfolio as well as efficiency gains across the organization. SG&A expenses for the quarter were $282 million, a 5% increase year-over-year. We continue to maintain cost discipline across the organization while investing for growth.

本季研發費用為5.83億美元，較去年下降27%，主要因我們傳染病產品組合的研究完成與逐步收尾，以及全組織效率提升所致。本季銷售、一般及行政（SG&A）費用為2.82億美元，年增5%。我們在投資成長的同時，持續在全組織維持成本紀律。

Our income tax provision was immaterial in both periods. Net income for the quarter was $160 million, an improvement of $362 million compared to last year. Diluted earnings per share was $0.38, compared to a loss per share of $0.51 last year.

兩個期間的所得稅費用皆不具重大性。本季淨利為1.60億美元，較去年改善3.62億美元。稀釋後每股盈餘為0.38美元，相較去年每股虧損0.51美元。

We ended the quarter with cash and investments of $8 billion, up from $6.9 billion at the end of the second quarter. The increase was primarily driven by $2.6 billion of net proceeds from our convertible note issuance and capped call transaction, partially offset by a $950 million litigation settlement payment as well as the seasonal impact to working capital.

本季末現金與投資為80億美元，高於第二季末的69億美元。增加主要來自我們發行可轉換公司債及上限買權（capped call）交易取得的26億美元淨收益，部分被9.50億美元的訴訟和解付款以及營運資金的季節性影響所抵銷。

Now let's turn to our financial framework for 2026. For total revenue, as I mentioned in my earlier remarks, we are improving our revenue outlook to a range of 15% to 25% growth, which exceeds our prior framework of up to 10% growth. Cost of sales is unchanged at $1.7 billion, which includes $0.9 billion of expense related to the previously announced litigation settlement charge.

現在讓我們談談2026年的財務框架。就總營收而言，如我先前所述，我們將營收展望上調至成長15%至25%的區間，超過先前最高成長10%的框架。銷貨成本維持不變為17億美元，其中包含先前已宣布之訴訟和解費用相關的9億美元支出。

We are lowering our R&D expense by $200 million to $2.7 billion due to further wind-down of studies and continued operational efficiencies. SG&A expenses are still expected to be approximately $1 billion, flat versus the prior year. Similar to last year, we expect higher SG&A expenses in the fourth quarter primarily due to commercial related activity.

由於研究進一步收尾以及持續的營運效率提升，我們將研發費用下調2億美元至27億美元。SG&A費用仍預期約為10億美元，與前一年持平。與去年類似，我們預期第四季SG&A費用較高，主要因商業相關活動所致。

In aggregate, excluding the $0.9 billion litigation charge, we are expecting total GAAP operating expenses of $4.5 billion and $3.8 billion of cash costs, which excludes stock-based compensation, depreciation and amortization.

合計而言，在排除9億美元訴訟費用後，我們預期GAAP營業費用總額為45億美元，現金成本為38億美元；現金成本不包含以股份為基礎的薪酬、折舊與攤銷。

Each reflects a $200 million improvement compared to our previous framework. We expect taxes to be negligible in 2026. And we are lowering our capital expenditure estimate to $200 million from our previous range of $200 million to $300 million.

兩者相較我們先前的框架皆改善2億美元。我們預期2026年的稅負可忽略不計。我們也將資本支出（CapEx）估計自先前2億至3億美元的區間下調至2億美元。

Cash and investments are now projected to be between $8.1 billion and $8.3 billion at the end of 2026. Excluding the $2.6 billion net proceeds from the convertible note and capped call transaction, our cash projection would be $5.5 billion to $5.7 billion, which is an improvement from our previous framework of $4.7 billion to $5.2 billion.

目前預估2026年末的現金與投資將介於81億至83億美元之間。若排除可轉換公司債與上限買權交易的26億美元淨收益，我們的現金預估將為55億至57億美元，較先前框架的47億至52億美元有所改善。

The increase in our cash projection is due to our improved revenue outlook and reductions in both our cash cost and CapEx projections. Our cash cost framework does not assume any additional drawdown from our remaining $0.9 million undrawn credit facility.

現金預估上調係因營收展望改善，以及我們對現金成本與資本支出預估的下調。我們的現金成本框架未假設會從剩餘的90萬美元未動用信用額度中再額外提用。

With that, I will now turn the call over to Stephen.

接下來，我將把電話會議交給Stephen。

Thank you, Jamey, and good morning or good afternoon, everyone. I'll now take you through our recent business updates. As a reminder, slide 12 outlines our multiyear revenue growth strategy, which continues to be anchored in two key drivers: geographic expansion and portfolio expansion through continued pipeline advancement.

謝謝你，Jamey，各位早安或午安。接下來我將帶各位回顧我們近期的業務更新。提醒一下，第12頁投影片概述我們的多年期營收成長策略，其核心仍聚焦於兩大關鍵驅動因素：地理擴張，以及透過持續推進研發管線來擴張產品組合。

We are building a more diversified portfolio with new opportunities across respiratory vaccines, oncology and rare diseases, while expanding our commercial footprint in markets around the world.

我們正打造更為多元化的產品組合，在呼吸道疫苗、腫瘤學與罕見疾病等領域開拓新機會，同時擴大全球各市場的商業版圖。

We're making tangible progress against this strategy with several important milestones achieved during the quarter. Starting with mFLUSIVA, we recently received FDA approval for adult age 50 to 64 and accelerated approval for adults age 65 and older in the US.

本季我們在此策略上取得具體進展，達成數項重要里程碑。以mFLUSIVA為例，我們近期在美國取得FDA核准，適用於50至64歲成人，並取得65歲以上成人的加速核准。

In Canada, we secured approvals for both mFLUSIVA and mCOFLU, the local brand name for mCOMBRIAX, for adults aged 60 and older. For our mNEXSIPKE, we saw approvals for the annual strain updates in the United States, Canada, Japan and Taiwan for the 2026, 2027 vaccination season.

在加拿大，我們取得mFLUSIVA與mCOFLU（mCOMBRIAX的當地品牌名稱）兩者的核准，適用於60歲以上成人。就mNEXSIPKE而言，我們在美國、加拿大、日本與台灣取得2026、2027接種季的年度株更新核准。

And for mRESVIA, we continue to make progress in the US and international markets. We expanded our international presence with a five year agreement signed with a local manufacturer in Mexico to support COVID-19 vaccine supply.

至於mRESVIA，我們在美國與國際市場持續取得進展。我們與墨西哥當地製造商簽署為期五年的協議，以支援COVID-19疫苗供應，進一步擴大我們的國際布局。

And finally, in oncology, we presented positive Phase III data for intismeran in adjuvant melanoma at the ESMO Presidential Symposium, as highlighted earlier. These milestones demonstrate continued execution against our strategy to drive revenue growth.

最後，在腫瘤學方面，我們在ESMO主席論壇（Presidential Symposium）上發表intismeran用於輔助治療黑色素瘤的正向第三期數據，如先前所強調。這些里程碑顯示我們持續落實策略以推動營收成長。

Turning to our approved infectious disease portfolio. We continue to make progress across our five commercial products, starting with our COVID vaccine.

接著談我們已核准的傳染病產品組合。我們在五項商業化產品上持續推進，先從COVID疫苗開始。

As I mentioned earlier, mNEXSPIKE received approval for the updated XFG strain for this coming vaccination season in the United States, Canada, Japan and Taiwan, with additional regulatory reviews and filings underway.

如我先前提到，mNEXSPIKE已在美國、加拿大、日本與台灣取得即將到來接種季之更新XFG株的核准，並且仍有其他法規審查與送件正在進行中。

Spikevax has also received approval for the updated strain in these markets and also in the European Union. Deliveries of our updated COVID-19 vaccines are now underway globally.

Spikevax也已在這些市場以及歐盟取得更新株的核准。我們更新版COVID-19疫苗的交付目前已在全球展開。

Turning to RSV, mRESVIA is approved in 44 countries. We also received published results from a Phase III study evaluating revaccination with mRESVIA in adults aged 60 and older who had previously received a protein-based RSV vaccine.

接著談RSV，mRESVIA已在44個國家獲准。我們也取得並發表一項第三期研究結果，該研究評估在60歲以上、先前已接種蛋白質型RSV疫苗的成人中，以mRESVIA進行再次接種（revaccination）。

This study demonstrated robust immune responses comparable to those seen following the initial vaccination with mRESVIA, with no new safety concerns identified, highlighting the potential for mRESVIA in revaccination. A link to the study can be found on this slide.

該研究顯示強勁的免疫反應，與初次接種mRESVIA後所見反應相當，且未發現新的安全性疑慮，凸顯mRESVIA用於再次接種的潛力。本投影片提供研究連結。

For mFLUSIVA, our seasonal influenza vaccine, we have approvals in the United States and now Canada with reviews ongoing in the European Union, Australia and Taiwan. In the US the American Academy of Family Physicians has recommended mFLUSIVA for adults aged 65 and older as an enhanced influenza vaccine.

針對 mFLUSIVA（我們的季節性流感疫苗），我們已在美國取得核准，並已在加拿大取得核准；目前歐盟、澳洲與台灣仍在審查中。在美國，美國家庭醫師學會已建議 65 歲及以上成人接種 mFLUSIVA，作為加強型流感疫苗。

And finally, for mCOMBRIAX, our combination influenza and COVID-19 vaccine, we now have approvals in Europe and Canada. The product remains under review in Japan, the United Kingdom, Australia and Switzerland, with a decision on filing in the United States subject to further discussion with the FDA.

最後，針對 mCOMBRIAX（我們的流感與 COVID-19 聯合疫苗），我們目前已在歐洲與加拿大取得核准。該產品仍在日本、英國、澳洲與瑞士審查中；至於是否在美國提出申請，仍需與 FDA 進一步討論後再決定。

Turning to US respiratory vaccination trends. Overall demand remains strong, as I said before. Through late October, approximately 44.1 million flu, COVID-19 and RSV vaccinations have been administered in the retail and long-term care channels, a 3% increase over the comparable period last year.

接著談美國呼吸道疫苗接種趨勢。整體需求依然強勁，如我先前所說。截至 10 月下旬，零售與長期照護通路已施打約 4,410 萬劑流感、COVID-19 與 RSV 疫苗，較去年同期增加 3%。

Flu vaccinations are trending slightly ahead of last year, and COVID-19 vaccinations are trending slightly behind, but momentum in October suggests vaccinations may end up flat year-over-year in the channel. These trends demonstrate the healthy demand for seasonal respiratory vaccines in the United States.

流感疫苗接種略高於去年，而 COVID-19 疫苗接種略低於去年，但 10 月的動能顯示，該通路的接種量可能最終與去年同期持平。這些趨勢顯示美國對季節性呼吸道疫苗的需求健康。

Turning to our late-stage infectious disease pipeline and our norovirus vaccine program, mRNA-1403. As a reminder, as previously disclosed, the Phase III study did not meet the statistical criteria for early success at its interim analysis.

接著談我們後期感染性疾病研發管線，以及我們的諾羅病毒疫苗計畫 mRNA-1403。提醒一下，如先前揭露，第三期研究在期中分析時未達到提前成功的統計標準。

Following a review of the program, we have decided not to enroll an additional cohort this coming winter season. Instead we are engaging with health authorities to determine the next steps for the program. And we'll provide further updates following those discussions.

在審視該計畫後，我們決定在即將到來的冬季不再納入額外的受試者隊列。相反地，我們正與衛生主管機關溝通，以確定該計畫的下一步。在完成這些討論後，我們將提供進一步更新。

With that, I'll now turn the call over to David to review our oncology and rare disease pipeline.

接下來，我將把電話會議交給 David，由他回顧我們的腫瘤與罕見疾病研發管線。

Thank you, Stephen. Hello, everyone. I will review the progress across our oncology and rare disease pipeline, starting with intismeran autogene, our individualized cancer therapy, which is being developed in partnership with Merck.

謝謝你，Stephen。各位好。我將回顧我們在腫瘤與罕見疾病研發管線的進展，先從 intismeran autogene（我們的個人化癌症療法）開始；該療法正與默克（Merck）合作開發。

Last month, we presented the positive Phase III INTerpath-001 melanoma results at the Presidential Symposium at ESMO, and I'll discuss these in greater detail shortly. A link to the ESMO presentation can be found at the bottom of the slide.

上個月，我們在 ESMO 的總統研討會（Presidential Symposium）上發表了第三期 INTerpath-001 黑色素瘤的正面結果，我稍後會更詳細說明。ESMO 簡報的連結可在投影片底部找到。

Beyond melanoma, our intismeran development program continues to advance across multiple tumor types and stages of disease. In non-small cell lung cancer, the adjuvant Phase III study is fully enrolled. Two additional Phase III studies in non-small cell lung cancer continue to enroll patients.

除黑色素瘤之外，我們的 intismeran 開發計畫也持續在多種腫瘤類型與不同疾病期別中推進。在非小細胞肺癌方面，輔助治療第三期研究已完成收案。另有兩項非小細胞肺癌第三期研究仍在持續收案。

One, Phase III, is in patients who did not have a pathologic complete response following neoadjuvant therapy. And the other Phase III is in Stage 1 disease evaluating intismeran both as a monotherapy and in combination with KEYTRUDA [QLEX].

其中一項第三期研究針對在新輔助治療後未達病理完全反應的患者。另一項第三期研究則在第一期疾病患者中，評估 intismeran 作為單藥治療以及與 KEYTRUDA [QLEX] 聯合治療。

Phase II studies in adjuvant renal cell carcinoma and muscle invasive bladder cancer are fully enrolled. Both of these studies are randomized against KEYTRUDA and are event-driven studies.

在輔助治療腎細胞癌與肌層浸潤性膀胱癌的第二期研究均已完成收案。這兩項研究皆以 KEYTRUDA 作為隨機對照，並且為事件驅動型研究。

We continue to enroll Phase II clinical studies in non-muscle invasive bladder cancer, metastatic melanoma and metastatic squamous non-small cell lung cancer. Phase I studies in pancreatic and gastric cancer are fully enrolled.

我們持續收案的第二期臨床研究包括：非肌層浸潤性膀胱癌、轉移性黑色素瘤，以及轉移性鱗狀非小細胞肺癌。胰臟癌與胃癌的第一期研究已完成收案。

At ESMO, we presented a poster highlighting encouraging translational data from the Phase I pancreatic cancer study. Despite the low tumor mutational burden typically seen in pancreatic cancer, we were able to generate neoantigen-specific T cell responses in all 19 evaluable patients. A link to the poster is at the bottom of the slide.

在 ESMO 上，我們發表了一張海報，重點呈現第一期胰臟癌研究中令人鼓舞的轉譯數據。儘管胰臟癌通常腫瘤突變負荷偏低，我們仍能在 19 位可評估患者全數誘發新抗原特異性 T 細胞反應。海報連結位於投影片底部。

Now let's review the Phase III melanoma results. In the INTerpath-001 trial, the primary endpoint was relapse-free survival. Intismeran plus pembrolizumab demonstrated a significant 42% reduction in the risk of recurrence or death, compared with pembrolizumab alone.

現在我們來回顧第三期黑色素瘤結果。在 INTerpath-001 試驗中，主要終點為無復發存活期（RFS）。與單用 pembrolizumab 相比，intismeran 加上 pembrolizumab 顯示復發或死亡風險顯著降低 42%。

The hazard ratio was 0.58 and P value below 0.001. These remarkable results were observed at the first interim analysis of this large randomized Phase III trial enrolling more than 1,100 patients with resected Stage IIb through IV melanoma.

風險比（hazard ratio）為 0.58，P 值低於 0.001。這些卓越結果出現在這項大型隨機第三期試驗的首次期中分析；該試驗納入超過 1,100 名已切除之 IIb 期至 IV 期黑色素瘤患者。

At two years, recurrence-free survival was 82.2% in the combination arm, compared with 70% for pembrolizumab alone, representing a 12 percentage point absolute improvement.

在兩年時，聯合治療組的無復發存活率為 82.2%，相較之下單用 pembrolizumab 為 70%，絕對提升 12 個百分點。

These results represent two important firsts. The first positive Phase III trial for an individualized cancer vaccine and the first positive Phase III trial demonstrating benefit over anti-PD-1 therapy in adjuvant melanoma.

這些結果代表兩項重要的「首次」。第一個個人化癌症疫苗的第三期陽性試驗，以及第一個在輔助治療黑色素瘤中證實優於抗 PD-1 治療的第三期陽性試驗。

This is a summary of the Phase II results at three different follow-ups. That study also tested intismeran plus pembrolizumab versus pembrolizumab monotherapy and also had an RFS primary endpoint.

這是第二期結果在三個不同追蹤時間點的摘要。該研究同樣比較 intismeran 加上 pembrolizumab 與 pembrolizumab 單藥治療，且主要終點亦為 RFS。

What's particularly remarkable is the consistency between the Phase II hazard ratio of 0.56 and the Phase III hazard ratio of 0.58 at the primary analysis where both had similar follow-up. In our Phase II study, the RFS hazard ratio improved, from 0.56% to 0.51% at three years.

特別值得注意的是，在兩項研究追蹤期相近的主要分析時點，第二期的風險比 0.56 與第三期的風險比 0.58 具有高度一致性。在我們的第二期研究中，RFS 的風險比在三年時由 0.56 進一步改善至 0.51。

And that benefit was maintained through five years of follow-up. We are optimistic about the potential to see similar strengthening of the treatment benefit in Phase III as the data matures.

而且這項效益在五年的追蹤中仍得以維持。隨著數據逐漸成熟，我們對於在第三期看到治療效益同樣增強的可能性抱持樂觀。

This optimism is further supported by sensitivity analyses from the Phase III trial. In the Phase III trial, we conducted prespecified sensitivity analyses that provide additional insights into the treatment to benefit.

第三期試驗的敏感度分析也進一步支持這份樂觀。在第三期試驗中，我們進行了預先指定的敏感度分析，提供更多關於治療效益的洞見。

One of these analyses evaluated the modified intent to treat or MITT population, which evaluates only patients who received the intended intismeran or placebo injection. Patients were randomized and received pembrolizumab but either relapsed or withdrew prior to the first dose of intismeran or placebo as planned were excluded.

其中一項分析評估修正意向治療（modified intent to treat，MITT）族群，也就是僅評估實際接受預定 intismeran 或安慰劑注射的患者。已隨機分派並接受 pembrolizumab，但在按計畫接受第一劑 intismeran 或安慰劑之前即復發或退出的患者，將被排除。

In other words, while the ITT analysis shows the results of a Phase III clinical trial, the MITT analysis, by limiting to patients actually treated with the blinded vaccine, shows the true treatment effect of intismeran.

換言之，ITT 分析呈現第三期臨床試驗的結果；而 MITT 分析透過限制於實際接受盲態疫苗治療的患者，呈現 intismeran 的真實治療效果。

In this MITT analysis, we observed an even greater treatment benefit with a 49% reduction in the risk of recurrence or death, compared with a 42% reduction observed in the primary ITT. Notably, the hazard ratio of 0.51 is consistent with what we observed in Phase II at the three and five year follow-ups.

在此 MITT 分析中，我們觀察到更大的治療效益：相較於主要 ITT 分析觀察到的 42% 降幅，復發或死亡風險降低 49%。值得注意的是，風險比 0.51 與我們在第二期研究三年與五年追蹤時所觀察到的結果一致。

At two years, the recurrence-free survival was 84.2% with the combination, compared with 70.4% for pembrolizumab alone, representing nearly a 14-percentage-point absolute improvement. Together, the ITT and MITT analyses reinforce the strength and consistency of the efficacy between Phase III and Phase II.

在兩年時，聯合治療的無復發存活率為 84.2%，相較之下單用 pembrolizumab 為 70.4%，絕對提升接近 14 個百分點。綜合而言，ITT 與 MITT 分析強化了第三期與第二期之間療效的強度與一致性。

The degree of benefit for the combination over pembrolizumab monotherapy, which itself is a great drug, is one reason that I am optimistic intismeran will work in other tumor types.

相較於單用 pembrolizumab（其本身就是一款非常優秀的藥物），該聯合療法所帶來的額外獲益幅度，是我對 intismeran 有望在其他腫瘤類型中發揮作用感到樂觀的原因之一。

The combination of intismeran plus pembrolizumab was generally well tolerated with findings consistent with the known safety profiles of the individual therapies. Adding intismeran did not meaningfully increase pembrolizumab associated adverse events of interest, which occurred in 36% of patients receiving the combination, compared to 35% of patients receiving pembrolizumab alone.

intismeran 加上 pembrolizumab 的聯合療法整體耐受性良好，觀察結果與各單一療法已知的安全性特徵一致。加入 intismeran 並未實質增加與 pembrolizumab 相關、值得關注的不良事件；接受聯合療法的患者中此類事件發生率為 36%，而單用 pembrolizumab 的患者為 35%。

And adverse events associated with intismeran were also consistent with its expected safety profile. The most common adverse events in the combination arm were pyrexia, injection site pain and fatigue. These events were generally low-grade, transient and were managed with standard supportive care.

而與 intismeran 相關的不良事件也與其預期的安全性特徵一致。聯合治療組最常見的不良事件為發熱、注射部位疼痛與疲勞。這些事件通常為低等級、短暫，並可透過標準支持性治療加以處理。

These findings are encouraging, particularly in the context of the significant improvement in relapse-free survival demonstrated in the study.

這些發現令人鼓舞，特別是在本研究顯示無復發存活期顯著改善的背景下。

I'll now turn to our broader oncology portfolio. Outside of intismeran we continue to advance a diversified portfolio of oncology programs across cancer antigen therapies, T-cell engagers and cell therapy enhancement.

接下來我將談談我們更廣泛的腫瘤產品組合。除 intismeran 之外，我們持續推進多元化的腫瘤研發組合，涵蓋癌症抗原療法、T 細胞接合器以及細胞治療增強。

Starting with mRNA-4359, our cancer antigen therapy. We have an ongoing Phase II study in first-line metastatic melanoma, second-line or later metastatic melanoma and first-line metastatic non-small cell lung cancer.

先從我們的癌症抗原療法 mRNA-4359 談起。我們正在進行一項第二期研究，涵蓋一線轉移性黑色素瘤、二線或後線轉移性黑色素瘤，以及一線轉移性非小細胞肺癌。

Our mRNA-4194 program is progressing in a Phase I/II study in Lynch syndrome with Phase I dose escalation ongoing. We all continue to advance mRNA-4106 and mRNA-4200 with Phase I studies dosing patients currently.

我們的 mRNA-4194 計畫正在林奇症候群的第一/二期研究中推進，目前第一期劑量遞增仍在進行中。我們也持續推進 mRNA-4106 與 mRNA-4200，第一期研究目前正在對患者給藥。

Turning to our T-cell engager program, mRNA-2808, is in a Phase I study in multiple myeloma. The initial clinical results have been selected for an oral presentation at the upcoming ASH Annual Meeting in December, and we look forward to presenting the data and advancing this program.

再來談我們的 T 細胞接合器計畫 mRNA-2808，目前正於多發性骨髓瘤進行第一期研究。初步臨床結果已獲選於 12 月即將舉行的 ASH 年會進行口頭報告，我們期待分享數據並推進此計畫。

Finally, in collaboration with Immatics, we continue dosing in the Phase I study of our cell therapy enhancer, mRNA-4203 in combination with anzu-cel. Across these programs, we're evaluating several distinct therapeutic approaches and continue to generate clinical evidence to guide further development.

最後，與 Immatics 合作方面，我們持續在第一期研究中給藥，評估我們的細胞治療增強劑 mRNA-4203 與 anzu-cel 的聯合使用。在這些計畫中，我們正在評估數種不同的治療策略，並持續產生臨床證據以指引後續開發。

Turning briefly to our rare disease pipeline, our registrational trial in propionic acidemia, or PA, is on track. And we look forward to the results later this year. For methylmalonic acidemia, or MMA, we've deferred the decision to initiate a pivotal trial until after the PA readout.

簡要談談我們的罕見疾病研發管線：我們在丙酸血症（propionic acidemia，PA）的註冊性試驗進展如期。我們期待在今年稍晚取得結果。至於甲基丙二酸血症（methylmalonic acidemia，MMA），我們已將是否啟動關鍵性試驗的決策延後至 PA 讀出之後。

With that, I'll hand the call back to Stephane.

接下來我把電話交回給 Stephane。

Thank you, David, Stephen and Jamey. Looking ahead, we continue to see important value drivers across our commercial business, financial performance and pipeline. We have raised our full year 2026 revenue growth expectations to between 15% and 20% growth, exceeding our previous revenue growth expectation of up to 10%.

謝謝你，David、Stephen 和 Jamey。展望未來，我們持續在商業業務、財務表現與研發管線上看到重要的價值驅動因素。我們已將 2026 全年營收成長預期上調至 15% 至 20% 的成長，超過先前最高 10% 的營收成長預期。

We also continue to execute with financial discipline, lowering our adjusted cash cost target by another $200 million to approximately $3.8 billion for fiscal year '26. And we have raised our year-end cash and investment outlook to between $8.1 billion and $8.3 billion.

我們也持續以財務紀律執行，將 2026 會計年度調整後現金成本目標再下調 2 億美元至約 38 億美元。同時，我們也將年末現金與投資展望上調至 81 億至 83 億美元。

On the commercial side, we continue to pursue additional regulatory approvals to expand the global reach of our respiratory vaccine portfolio.

在商業面，我們持續爭取更多監管核准，以擴大我們呼吸道疫苗產品組合的全球覆蓋。

Turning to our pipeline. 2026 has been a landmark year for oncology, highlighted by our positive Phase III melanoma result for intismeran and the presentation of encouraging early pancreatic cancer data at ESMO.

再來談研發管線。2026 年是腫瘤領域的里程碑之年，亮點包括 intismeran 在黑色素瘤的第三期試驗取得正面結果，以及在 ESMO 發表令人鼓舞的胰臟癌早期數據。

Looking ahead, key milestone includes our events-driven Phase II renal cancer readout, the intismeran BLA submission, the presentation of mRNA-2808 at ASH and our registrational readout in propionic acidemia, or PA, our most advanced regenerative disease program.

展望未來，關鍵里程碑包括：以事件驅動的第二期腎癌讀出、intismeran 的 BLA 申請遞交、mRNA-2808 在 ASH 的發表，以及我們在丙酸血症（PA）的註冊性讀出——這是我們最先進的再生疾病計畫。

Our priorities remain clear: grow our commercial business, maintain financial discipline and advance our pipeline towards important clinical and regulatory milestones. I'm very proud of what our team has accomplished this year and excited about the opportunities ahead for Moderna.

我們的優先事項依然明確：擴大商業業務、維持財務紀律，並推進研發管線以達成重要的臨床與監管里程碑。我為團隊今年的成果感到非常自豪，也對 Moderna 未來的機會感到振奮。

We look forward to hosting the investment community next week at our upcoming Analyst Day on November 12. The event will be held in person at our intismeran manufacturing site in Marlborough, Massachusetts, where attendees will have also the opportunity to tour the site. A webcast of our presentation will be available for those joining remotely.

我們期待於下週 11 月 12 日的分析師日接待投資社群。活動將在麻薩諸塞州馬爾伯勒（Marlborough）的 intismeran 製造基地以實體方式舉行，與會者也將有機會參觀該基地。對於遠端參與者，我們將提供簡報的網路直播。

I want to close thanking our teams around the world for their dedication and execution. This has been an important year for Moderna and our progress reinforce what we can accomplish when we combine both science with disciplined execution.

最後，我要感謝全球各地團隊的投入與執行力。這是 Moderna 非常重要的一年，而我們的進展再次證明，當我們把科學與有紀律的執行結合起來時，就能達成的成果。

Our platform is delivering. Five approved infectious disease vaccines around the world, positive Phase III for intismeran and the new modality with mRNA-2808 proof of concept in multiple myeloma T-cell engagers. Our mission remains at the heart of everything we do: to deliver the greatest possible impact to people for mRNA medicine.

我們的平台正在交付成果。全球已有五款獲核准的傳染病疫苗、intismeran 的第三期正面結果，以及 mRNA-2808 這一新型態在多發性骨髓瘤 T 細胞接合器上的概念驗證。我們的使命始終是我們一切工作的核心：為 mRNA 藥物為人們帶來盡可能最大的影響。

With that, we'll be happy to take your questions.

接下來，我們很樂意回答各位的問題。

(Operator Instructions) Salveen Richter with Goldman Sachs.

（接線員指示）高盛的 Salveen Richter。

Two questions for me. One is, could you frame your confidence into the interim data in renal cell carcinoma, particularly as we think about the statistical plan with regard to a number of events that needs to be hit around that interim?

我有兩個問題。第一個是，能否請你說明一下你對腎細胞癌期中數據的信心程度，特別是當我們考量統計計畫中，該期中分析需要達到的事件數量時？

And then if you could also touch on the fact that there've been some questions in the contribution of the LNP to immunogenicity with regard to the melanoma trial, and maybe just help frame that for us as well?

另外，也請你談談：針對黑色素瘤試驗，有一些問題在於 LNP 對免疫原性的貢獻；能否也幫我們釐清一下？

In terms of the timing, it's event driven for the RCC trial, so it could be end of this year or early next year. In terms of the confidence of that, why I'm confident, I would say probably a couple of reasons.

就時程而言，RCC 試驗是事件驅動，因此可能在今年年底或明年年初。至於我為何有信心，我想大概有幾個原因。

First is that we know that RCC is an anti-PD-1 sensitive tumor, anti-PD-1s work by T cells, by reactivating T cells. We work by generating novel T cells. And so it's a T cell sensitive disease, and so that's confidence number one.

第一，我們知道 RCC 是對抗 PD-1 治療敏感的腫瘤；抗 PD-1 的作用機制是透過 T 細胞、也就是重新活化 T 細胞。而我們的作用是產生新的 T 細胞。因此這是一種對 T 細胞敏感的疾病，這是信心來源之一。

Confidence number two derives from the fact that in our Phase II trial, we saw efficacy in the melanoma population at both that was equivalent for high-TMB and for low-TMB patients. And if you overlap the low-TMB spectrum in the melanoma, it actually does overlap with RCC.

第二個信心來源是：在我們的第二期試驗中，我們在黑色素瘤族群中看到的療效，對高 TMB 與低 TMB 患者而言是相當的。而如果你把黑色素瘤中的低 TMB 範圍拿來對照，實際上與 RCC 是有重疊的。

And then finally, the treatment benefits that we saw in the primary analysis has a ratio of 0.58 versus pembrolizumab alone, that was the same treatment effect that pembrolizumab alone saw versus placebo in their KEYNOTE 54, and then we know KEYTRUDA went on to be positive in RCC as well.

最後，我們在主要分析中看到的治療獲益，相較於單用 pembrolizumab 的比值為 0.58；這與 pembrolizumab 單用在 KEYNOTE 54 中相較於安慰劑所看到的治療效果相同，而我們也知道 KEYTRUDA 後續在 RCC 中同樣取得了正面結果。

So those are the reasons why I have confidence or believe that we are likely potentially to have a positive result. I don't say anything more about the statistical analysis plan.

所以，這些就是我有信心、或相信我們很可能有機會得到正面結果的原因。我就不再多談統計分析計畫了。

In terms of the LNP immunogenicity question, this is a question that's been going on for a while just (inaudible) that came up a few years ago when MD Anderson published a retrospective analysis. And it wasn't a randomized trial. It was just observation.

就 LNP 免疫原性這個問題而言，這個問題已經討論了一段時間，只是（聽不清）幾年前 MD Anderson 發表一項回溯性分析時又被提出來。而那不是一項隨機試驗。只是觀察性研究。

And they suggested that patients who got the mRNA LNP vaccine had better outcomes to immunotherapy. That has, that data from MD Anderson has subsequently been repeated and not been repeated by different groups.

他們提出，接受 mRNA LNP 疫苗的病人，在免疫治療上的結局更好。此後，MD Anderson 的那份資料被不同團隊重複驗證，也有團隊未能重複出相同結果。

And in fact, most recently, Memorial Sloan Kettering, which is the other large cancer center in the US, came out with their own analysis showing that actually there was no treatment effect by the addition of mRNA LNP.

事實上，最近 Memorial Sloan Kettering（美國另一家大型癌症中心）也發表了他們自己的分析，顯示其實加入 mRNA LNP 並沒有帶來治療效果。

So I don't think that that answer is clear. I don't think the evidence is strong enough to claim it. And I don't think LNP T can generate such an incredibly strong hazard ratio in the adjuvant setting.

所以我不認為這個答案是明確的。我不認為證據強到足以主張這一點。而且我不認為 LNP T 能在輔助治療情境下產生如此驚人的風險比（hazard ratio）。

Terence Flynn with Morgan Stanley.

Morgan Stanley 的 Terence Flynn。

Great. I was just wondering, I know you're not going to guide on price at this point for INT, but I was just wondering if you could talk through some of the inputs that you and Merck are considering as you think about pricing that therapy?

很好。我只是想問，我知道你們目前不會就 INT 的價格提供指引，但想請你們談談，在思考該療法定價時，你們和默克正在考量哪些輸入因素？

And then the second question I had is just on the Phase II RCC study, if those data are positive, do you think that can support a registration in that setting?

第二個問題是關於第二期 RCC 研究：如果那些數據是正面的，你認為能否支持在該適應症情境下的註冊申請？

Look, this is Stephen, I'll take the first part of it on price and then I think hand it over to David. On price, look, it's premature at this point. We're working on getting a submission done this year and obviously working towards approval.

你看，我是 Stephen，我先回答價格的第一部分，然後我想交給 David。關於價格，現在談還太早。我們正努力在今年完成申報，並且顯然朝核准邁進。

We will always look to price our products to represent the value they create in health care systems. And obviously, we're thrilled by the data, but it is premature at this point to say anything more. And we'll work closely with Merck on that process.

我們一向會以產品在醫療體系中所創造的價值來定價。當然，我們對這些數據感到非常振奮，但現在要再多說仍為時過早。我們也會在這個流程上與默克密切合作。

Terence, in regard to your second question, look, it's a pretty large randomized, well-controlled Phase II with 282 patients. But it is a Phase II.

Terence，關於你的第二個問題，這是一項相當大型、隨機分派、控制良好的第二期試驗，共 282 位病人。但它畢竟是第二期。

So at a base case, I would say it can be practice-informing, especially with compendium listing, if it's positive. In an upside, if the results are very strong, I think we can consider taking it to FDA. But it will be data dependent.

所以在基本情境下，我會說如果結果為正，它可以提供臨床實務參考，尤其是在彙編（compendium）收錄的情況下。在較樂觀的情境下，如果結果非常強勁，我認為我們可以考慮提交 FDA，但將取決於數據表現。

Ellie Merle with Barclays.

Barclays 的 Ellie Merle。

On the back of the pancreatic data at ESMO, can you elaborate on how you're thinking about potential next development steps here? Would you study in combo with PD-1, with chemo or both? And then just a quick one on RCC. If the study is not successful in the first interim, is that something you'd disclose if it moves on to additional analyses?

承接 ESMO 上的胰臟數據，你能否更詳細說明你們對於接下來可能的開發步驟是怎麼想的？你們會研究與 PD-1 聯合、與化療聯合，或兩者都做嗎？另外一個關於 RCC 的快問：如果研究在第一次期中分析不成功，但仍繼續進行後續分析，你們會揭露這件事嗎？

Ellie, so with regard to the PDAC, look, the good news is that in this low-TMB tumor, we were able to generate cassettes from the patients. And in all of the evaluable patients, we were able to see T cell reacting to those neoantigens.

Ellie，關於 PDAC，你看，好消息是，在這種低 TMB 腫瘤中，我們能夠從病人身上產生（疫苗）卡匣（cassettes）。而且在所有可評估的病人中，我們都能看到 T 細胞對那些新抗原產生反應。

So I think that's a really good sign. And we did it in combination with the standard of care, which is FOLFIRINOX. So it informed us that it can safely be given with chemotherapy, which I think we probably assumed it could, and that we can still generate T cell reactivity in the face of the addition of chemotherapy.

所以我認為這是非常好的訊號。而且我們是與標準治療 FOLFIRINOX 聯合使用來做的。因此這也讓我們了解它可以安全地與化療併用——我想我們原本大概也這麼假設——並且即使加入化療，我們仍能誘發 T 細胞反應性。

I think for next steps, we're actively discussing that with Merck right now. I think it could be in the same regimen that we studied, it could be in combination with the RAS inhibitor.

至於下一步，我們目前正與默克積極討論。我認為可能會沿用我們研究過的相同療程，也可能會與 RAS 抑制劑聯合。

I think we need to do a little more thinking about that because the standard of care is changing. And in terms of the disclosure, I don't think we've decided yet how we're going to handle that.

我想我們需要再多思考一下，因為標準治療正在改變。至於是否揭露，我不認為我們已經決定要如何處理。

Edward Tenthoff with Piper Sandler.

Piper Sandler 的 Edward Tenthoff。

Great. And congrats on all the progress. My questions are just on the BLA for intismeran. What still has to happen? And are you working collaboratively with Merck on that?

很好。也恭喜你們取得所有進展。我的問題是關於 intismeran 的 BLA。接下來還需要發生什麼？你們是否正與默克協作進行？

Are they driving the bus? And then just trying to get a sense for when we might get data from the lung cancer studies. And maybe you can kind of break out sort of how those different studies might read out.

是他們在主導嗎？另外想了解一下，我們大概何時能看到肺癌研究的數據。也許你可以大致拆解一下不同研究可能的讀出時間點。

Ted, it's Stephen. I'll take the first part of that and then hand it over to David to speak through the lung cancer work. So we're working intensely with our partner, Merck.

Ted，我是 Stephen。我先回答第一部分，然後交給 David 來說明肺癌方面的工作。我們正與合作夥伴默克密切且高強度地合作。

As we said earlier, as Stephane mentioned a moment ago, we are working to make sure that submission with the BLA happens this year. And if everything goes well, as has been said before, we would hope to see approval next year.

如同我們先前所說、以及 Stephane 剛才提到的，我們正努力確保今年完成 BLA 的申報。如果一切順利，如同之前所說，我們希望明年能看到核准。

There are lots of steps, as you know, pulling those things together, including getting ready for pre-approval inspections and everything.

如你所知，這當中有很多步驟需要整合，包括為核准前查核（pre-approval inspections）等各項工作做好準備。

And I can assure you, working around the clock to make sure that not only the submission happens on time, but the review is facilitated with the FDA. Because our goal here ultimately is approval. But working very closely with Merck together on that as we speak. David?

我可以向你保證，我們日以繼夜地工作，確保不僅申報能準時完成，也能促進 FDA 的審查流程，因為我們最終的目標就是核准。而且此刻我們正與默克非常緊密地合作。David？

Thanks, Stephen. The lung cancer adjuvant program is actually really comprehensive. We announced that we have just about completed. We have completed enrollment in the intismeran, in the INTerpath-002, which is adjuvant after chemotherapy, with no neoadjuvant therapy. In fact, this was the fastest enrolling, one of Merck's fastest enrolling trials, just to give you a sense of the excitement.

謝謝，Stephen。肺癌輔助治療計畫其實非常全面。我們宣布我們幾乎已經完成。我們已完成 intismeran 的 INTerpath-002 收案，這是化療後的輔助治療，且沒有新輔助治療。事實上，這是默克收案速度最快的試驗之一，讓你感受一下大家的興奮程度。

We are still ongoing in enrollment in patients who had neoadjuvant pembro chemo and did not have pathologic complete response. That's still enrolling.

我們仍在持續收納曾接受新輔助 pembro 化療、但未達病理完全反應的病人。那項研究仍在收案中。

So it's too soon to know what's going to happen in terms of timing there. And then we have the really exciting high-risk Stage I lung cancer Phase III, where the first time we're testing intismeran monotherapy in one of the arms, also still enrolling there.

因此現在還太早，無法判斷那邊在時間點上會如何發展。另外還有一項非常令人振奮的高風險第一期肺癌第三期試驗，我們首次在其中一個組別測試 intismeran 單藥治療，那邊也仍在收案中。

In terms of readouts and timings, I think it's a little too soon. We just finished PREDICT. We just finished enrolling. And so now we need to start monitoring events and then we'll have a better idea about timing.

就讀出結果與時程而言，我認為現在談還稍微太早。我們剛完成 PREDICT，也剛完成收案。因此現在需要開始監測事件，之後我們才會對時程有更清楚的概念。

Alec Stranahan with Bank of America.

美國銀行（Bank of America）的 Alec Stranahan。

Two from us, one on 2808 and one financial question. Looking forward to the data at ASH, I guess, what will the update add beyond the first 11 response available patients in terms of more patients, higher dose, durability?

我們有兩個問題，一個關於 2808，另一個是財務問題。展望 ASH 的數據，我想問這次更新相較於目前可用的前 11 位有反應患者資料，會增加哪些內容？例如更多患者、更高劑量、反應持久性？

And I guess, how does this program maybe reflect the broader oncology opportunity you see for the platform? And quickly on your 2026 growth guidance increase, how much of this came from timing, meaning deliveries moved into 2026? And does any of it, I guess, pull revenue forward from 2027?

另外，我想請教這個計畫如何反映你們對平台在腫瘤領域更廣泛機會的看法？再快速問一下你們上調 2026 年成長指引：其中有多少是來自時點因素，也就是交付延後到 2026 年？以及其中是否有任何部分等於把原本 2027 年的營收提前到 2026 年？

Alec, with regard to program, thanks for highlighting 2808, it is actually one of the exciting early-stage programs we have. There have been, obviously, lots of T-cell engagers in myeloma. There have been some that are targeting two antigens. This, of course, is the first time ever that three antigens have been targeted, and that's why we're excited this is going to be an oral presentation.

Alec，關於這個計畫，謝謝你特別提到 2808；它其實是我們令人振奮的早期計畫之一。在骨髓瘤領域，顯然已經有很多 T 細胞接合器（T-cell engagers）。也有一些是同時鎖定兩個抗原。而這當然是史上第一次鎖定三個抗原，這也是我們很興奮、並且會以口頭報告形式發表的原因。

The data cut is later for the oral than it was the abstract, so you can expect more patients, longer follow-up and evaluation of what, whether we can get a deeper response and activity in patients who had prior BCMA and GPCR 5D.

口頭報告的資料截點（data cut）比摘要時更晚，因此你可以預期會有更多患者、更長的追蹤期，並評估我們是否能在曾接受過 BCMA 與 GPCR 5D 治療的患者中，取得更深的反應與活性。

In terms of the broader implications, this is testing a hypothesis we have that one of the benefits of our platform is that we can multiplex. And so we're multiplexing care against different tumor antigens in the form of 3 T-cell engagers.

就更廣泛的意涵而言，這是在驗證我們的一個假設：我們平台的優勢之一是可以進行多重化（multiplex）。因此我們以 3 個 T 細胞接合器的形式，針對不同腫瘤抗原進行多重化攻擊。

But it can also show that we can multiplex on the other side, going after different T cell stimulation approaches as well. So the fact that this works shows that we can multiplex, we can generate systemic proteins to treat cancer. And I think that's been a very important proof of principle.

但它也能顯示我們可以在另一端進行多重化，也就是採用不同的 T 細胞刺激方式。因此，這個結果可行，顯示我們能夠多重化、能產生全身性蛋白質來治療癌症。我認為這是一個非常重要的概念驗證（proof of principle）。

Thanks, David. Yes. And Alec, thanks for the question. So we're encouraged that this is really broad-based growth this year. It is both US and international. And I'll just go back to some of my prepared remarks, which was we came into the year with two key growth drivers, mNEXSPIKE is performing extremely well in the US.

謝謝你，David。是的。Alec，也謝謝你的問題。所以我們很受鼓舞，因為今年的成長確實是廣泛性的。涵蓋美國與國際市場。我回到我先前準備的發言：我們在年初就有兩個關鍵成長動能，mNEXSPIKE 在美國的表現非常好。

But in addition to that, in the US, vaccination rates are stable, which Stephen walked through on his chart. Internationally, we came in thinking about the strategic partnerships, and those have all performed extremely well also.

此外，在美國，疫苗接種率維持穩定，Stephen 在圖表中也有說明。在國際市場方面，我們原先著眼於策略合作夥伴關係，而這些合作也都表現得非常好。

So when we look to 2027, I go back to what Stephen presented in terms of there are still four growth drivers out there. Flu is relatively immaterial right now for us in 2026, and we expect to grow next year. Europe opens up for us, Latin America partnerships, hopefully, we will have INT approved.

因此當我們看向 2027 年，我會回到 Stephen 所呈現的內容：外部仍然有四個成長動能。流感在 2026 年對我們目前而言相對不具重大性，但我們預期明年會成長。歐洲市場將對我們開放、拉丁美洲的合作夥伴關係，以及希望我們能取得 INT 的核准。

So we're quite encouraged. So again, it was a broad-based growth in 2026, and the two primary growth drivers are going well for us.

所以我們相當受到鼓舞。再次強調，2026 年是廣泛性的成長，而兩個主要成長動能對我們而言進展良好。

Myles Minter with William Blair.

William Blair 的 Myles Minter。

Congrats on the quarter and all of the updates for the INTerpath-001. I actually had just a question on norovirus. I think at your last quarterly update, you indicated you were going to enroll another cohort. Now you're not and you're going to the regulators. Just wondering what changed there and what you're hoping to get out of those regulatory discussions.

恭喜本季表現，以及 INTerpath-001 的所有更新。我其實有一個關於諾羅病毒（norovirus）的问题。我記得在上次季報更新時，你們表示會再收一個 cohort。但現在你們不這麼做，而是要去和監管機關溝通。想請教是什麼改變了？以及你們希望從這些監管討論中得到什麼？

Yes, Myles. At this point, I don't have much more to say than we already did. You're correct, we did not meet the criteria for early success, and we were going forward with a cohort initially. But as we reviewed the program, we think the most appropriate next step is not to go forward with that cohort, but instead consult with regulators.

是的，Myles。目前我能補充的不多，基本上就是我們先前所說的內容。你說得沒錯，我們沒有達到早期成功（early success）的標準，因此一開始是打算推進下一個 cohort。但在我們重新檢視該計畫後，我們認為最合適的下一步不是推進那個 cohort，而是改為諮詢監管機關。

And at this point, it's premature for me to guide any further on that. But once we've had those discussions with them about the potential next steps of the program, we'll be able to provide an update more broadly. So for now, we'll have to have those conversations before I can offer anything more.

而在此時此刻，我再進一步提供指引還言之過早。但一旦我們與他們就該計畫可能的下一步完成討論，我們就能提供更全面的更新。所以目前在我能再多說之前，我們必須先完成那些對話。

Tyler Van Buren TD Cowen.

TD Cowen 的 Tyler Van Buren。

Congrats on the quarterly results. So the melanoma INT results are clearly stellar. But regarding the next readout in RCC, some KOLs have brought up research suggesting that RCC immunogens may be driven in part by HIF-regulated endogenous retroviral elements. So can the current INT antigen selection process, identify and incorporate those types of noncanonical antigens? And how might that impact the probability of success?

恭喜季度業績。黑色素瘤的 INT 結果顯然非常亮眼。但關於腎細胞癌（RCC）的下一次讀出結果，有些關鍵意見領袖（KOL）提到研究顯示，RCC 的免疫原性可能部分由 HIF 調控的內源性逆轉錄病毒元件所驅動。那麼目前的 INT 抗原選擇流程，能否辨識並納入這類非典型（noncanonical）抗原？以及這可能如何影響成功機率？

Yes, it's an interesting hypothesis that has been put out there. I think it's a hypothesis and it's a question whether endogenous retrovirals play a role or not. What I do know is that our algorithm does include insertion deletions, indels, which are actually strongly demonstrated to be important in RCC, as well as neoantigens, and single-point neoantigens that is.

是的，這是一個被提出的有趣假說。我認為這仍是個假說，也就是內源性逆轉錄病毒是否扮演角色仍有待確認。我所知道的是，我們的演算法確實包含插入缺失（insertion deletions，indels），而這已被強力證實在 RCC 中很重要；同時也包含新抗原（neoantigens），也就是單點新抗原。

And then I'll also point you out to a publication recently from Dana-Farber, where they did their own personalized cancer vaccine, and were able to identify sufficient neoantigens without the addition of endogenous retroviral. So the ERVs are interesting, they're speculative, and I think more research needs to be made before we include them.

另外我也想提醒你注意 Dana-Farber 最近的一篇論文，他們做了自己的個人化癌症疫苗，且在不加入內源性逆轉錄病毒的情況下，也能辨識出足夠的新抗原。因此 ERV 的確有趣，但仍屬推測；我認為在把它們納入之前，還需要更多研究。

Andrew Tsai with Jefferies.

Jefferies 的 Andrew Tsai。

As we think about the BLA submission for melanoma with INT, can you talk about whether you would need some kind of special FDA approval on the algorithm side on top of the drug side? And secondly, if the power of AI continues to improve rapidly, can you just maybe talk about why competitors, hypothetically speaking, can't catch up to you on the algorithm side? Why do you think you have a protective moat?

在我們思考以 INT 用於黑色素瘤的 BLA 申請時，你能否談談除了藥物本身之外，演算法端是否也需要某種特殊的 FDA 核准？第二，如果 AI 的能力持續快速提升，你能否談談為什麼競爭對手（假設而言）無法在演算法端追上你們？你們認為自己的護城河在哪裡？

So first of all, yes, obviously, the algorithm for selection and, in fact, the entire front-end process for designing an INT for an individual patient, is a part of the drug. Effectively, there is software in it. And that is a proprietary feature of our platform, our technology. It's not something that will be readily available. The important question maybe is the one, the second part of yours, which is then, how does that play forward?

首先，是的，顯然用於選擇的演算法，以及事實上為個別患者設計 INT 的整個前端流程，都是藥物的一部分。實際上，其中包含軟體。而這是我們平台與技術的專有特徵。這不是能輕易取得的東西。也許更重要的問題是你第二部分的提問，也就是接下來這會如何延伸發展？

And we're incredibly excited by what we've learned in our clinical trials. And bear in mind, the randomized data we have on immunogenicity from Phase II was in about 150 people, about 100 people who received INT. They've now been followed through five years.

我們對於在臨床試驗中所學到的內容感到無比振奮。另外請記住，我們在第二期試驗中取得的免疫原性隨機數據約來自150人，其中約100人接受了INT。他們目前已追蹤至五年。

And at ASCO this year, we presented some of the update data, recent ESMO event, we presented some of that. We learned a tremendous amount the 34 neoantigens that we put into those people in that study.

而在今年的ASCO，我們發表了一些更新數據；在近期的ESMO會議上，我們也呈現了其中一部分。我們從該研究中放入受試者體內的34個新抗原學到了非常多。

What is remarkable is with the melanoma study that just read out, we've taken the number of patients up that we have that experience with by almost a factor of 10. And if you look across the other nine studies that are up and running, we'll go another factor of five again.

值得注意的是，隨著剛剛公布結果的黑色素瘤研究，我們擁有相關經驗的患者數量幾乎增加了近10倍。如果再看其他九項正在進行的研究，我們還會再增加約5倍。

So we're starting to develop a tremendous amount of real experience with what sorts of neoantigens are generating T cell clones, what are the features of that T cell clonality that we think is really valuable for a neoantigen vaccine and individualized neoantigen vaccine. And we are constantly looking to bring that back into how we predict and design INTs for individuals going forward.

因此，我們開始累積大量的真實經驗，了解哪些類型的新抗原會產生T細胞克隆，以及我們認為對新抗原疫苗與個人化新抗原疫苗真正有價值的T細胞克隆性特徵是什麼。我們也持續把這些學習回饋到未來如何為個體預測並設計INT。

That data is a gold mine. I think we presented this, 5,000 neoantigens across the 100-plus participants in that first study, in the Phase II, it's gone up by a factor of 10.

那些數據是一座金礦。我想我們曾展示過：在第一項研究（第二期）中，100多位受試者合計約5,000個新抗原；而現在這個數量已增加了10倍。

And we will be, with our partner, Merck, we're deeply going through that data and continuing to treat that proprietary information as one of the really special sauces, as we continue to try and make INTs more and more effective going forward in the, really in the decades ahead. So we think we're at the very beginning of scientific revolution, and we're excited to be in the lead and to have that proprietary information.

我們將與合作夥伴默克（Merck）一起深入分析這些數據，並持續把這些專有資訊視為真正的「獨門秘方」之一，因為我們會在未來、甚至是接下來幾十年裡，持續努力讓INT變得越來越有效。因此我們認為自己正處於科學革命的最初階段，我們很興奮能走在前端並擁有這些專有資訊。

Michael Yee with UBS.

UBS的Michael Yee。

Two questions. On INT, the clinical trial protocols are available for renal cell and bladder cancer, and we understand that they are an alpha spend, one-sided alpha of 0.10, very much like you nicely designed your Phase II melanoma study and very much the same assumptions. Do you stand by that protocol and can confirm that those assumptions are correct?

兩個問題。關於INT，腎細胞癌與膀胱癌的臨床試驗方案已可取得；我們理解其採用alpha支出（alpha spend）、單側alpha為0.10，與你們精心設計的第二期黑色素瘤研究非常相似，且假設條件也幾乎相同。你們是否仍支持該方案，並能確認這些假設是正確的？

And the second question is as it relates to filing in melanoma, is there a general timing guidance for that just so we can think about the gating steps and all the things that need to be done there in terms of the filing?

第二個問題與黑色素瘤的申報相關：是否有一個大致的時間指引，讓我們能思考申報過程中的關鍵步驟，以及在申報方面需要完成的所有事項？

Michael, we're not aware of the protocols that you cite, and I obviously can't comment on it, so I'm going to have to pass on that. In terms of the BLA, we're obviously working closely with Merck on that, and stay tuned for our next message on that.

Michael，我們並不清楚你所引用的那些方案，我也顯然無法對此評論，所以我只能先略過這題。至於BLA，我們當然正與默克密切合作處理；請持續關注我們下一次對此的訊息更新。

Courtney Breen with Bernstein.

Bernstein的Courtney Breen。

A couple for me. I did want to zoom back to the pancreatic cancer study, the Phase I data that you presented at ESMO this year. Obviously, we saw the neoantigen generation, the T cell expansion, et cetera, that you've spoken to.

我有幾個問題。我想回到你們今年在ESMO發表的胰臟癌研究第一期數據。顯然，我們看到了你們提到的新抗原生成、T細胞擴增等等。

There was also a small swimmer plot of kind of performance for these patients and recurrent details for these patients. Can you just help us understand what you're taking from that efficacy data so far?

另外也有一個小型的swimmer plot，呈現這些患者的表現以及復發相關細節。你們能否協助我們理解，到目前為止你們從那些療效數據中得到什麼結論？

We see it as relatively early compared to kind of what performance can be generated with FOLFIRINOX on its own. But just want to understand kind of what you're already able to take from those insights and the potential to move forward. Or do you need more time to assess that data before you would move forward?

我們認為相較於單用FOLFIRINOX可能達到的表現，這些結果看起來仍相對偏早期。但想了解你們目前已能從這些洞見中得到什麼、以及推進後續的可能性。或者你們是否需要更多時間評估這些數據，才會往前推進？

And then just the second question, just a really practical one on the revenue generation. Can you just talk a little bit about the ex US components here and how much of that is coming from kind of commitments, how much of that is coming from pure demand? And we're just trying to figure out how we kind of appropriately carry some of this forward.

第二個問題是比較實務面的，關於營收來源。能否談談美國以外（ex US）的組成，以及其中有多少來自承諾性（commitments），有多少來自純粹需求（pure demand）？我們想釐清應如何把其中一些因素合理地延伸到未來。

Courtney, this is David. Thank you for the pancreatic question. It was very exciting data because we can generate T cells reactive to neoantigens that are present in the PDAC patients, which is something that actually was not really necessarily given.

Courtney，我是David。謝謝你關於胰臟癌的問題。那是一組非常令人振奮的數據，因為我們能夠產生對PDAC患者體內存在的新抗原具有反應性的T細胞，而這件事其實並非理所當然。

In terms of the swimmer plot that you noticed, yes, I think I agree that it's probably too early, point number one. And point number two, this was a mix of patients. Some of them had neoadjuvant treatments, some of them didn't.

至於你注意到的swimmer plot，是的，我想我同意第一點：可能還太早。第二點：這是一組混合的患者。其中一些接受了新輔助治療（neoadjuvant treatments），一些則沒有。

And so it's really hard for us to discern an efficacy signal. I'm always careful about discerning efficacy signals in single-arm trial time-to-event analyses. I think the immunogenicity is data great, the safety is great, and we'll have to figure out the next step.

因此我們很難辨識出療效訊號。我一向對於在單臂試驗的事件時間（time-to-event）分析中辨識療效訊號保持謹慎。我認為免疫原性數據很棒，安全性也很棒，而下一步我們還需要再研議。

Question on international. So I would say a significant portion is very durable. We've talked about the strategic partnerships, and it comprises over 50% of our revenue for sure. But I think what's also great about our international growth is, one, we're playing in a lot of other markets outside of these strategic partnerships, that we have been for some time.

關於國際市場。我會說其中相當大的一部分非常具持續性。我們談過策略性合作夥伴關係，這部分確實占我們營收的50%以上。但我認為我們國際成長的另一個亮點是：第一，我們也在許多不屬於這些策略合作夥伴的其他市場中布局，而且已經有一段時間了。

And we are increasing share, to some degree, as well as, I think as I mentioned earlier, the vaccination rates are improving in a lot of these markets as well.

此外，我們在某種程度上也正在提升市占；同時如我先前提到的，許多市場的疫苗接種率也在改善。

So I think we are seeing a shift year-over-year globally that vaccination rates have become more stable. So we hope that that is pretty durable moving forward.

因此我認為我們看到全球的疫苗接種率在逐年（year-over-year）轉變，並變得更穩定。所以我們希望這種趨勢在未來能相當具有持續性。

Alexandria Hammond, Wolfe Research.

Wolfe Research的Alexandria Hammond。

So on INT, what learnings have you guys been able to take in regard to the optimal number of neoantigens coated? Do you think 34 is a sweet spot? Or do you think essentially next-generation assets or of your internal kind of platform could encompass more?

關於INT，你們在「最佳包覆（coated）的新抗原數量」方面有哪些學習？你們認為34是一個最佳甜蜜點（sweet spot）嗎？或者你們認為下一代資產或你們內部的平台基本上可以涵蓋更多？

I guess what kind of has the data demonstrated about how much of the breadth of these neoantigen payload matters. Is more always better or could a smaller number of newly highly immunogenic (inaudible) be more favorable?

我想問的是，數據顯示這些新抗原載荷（payload）的廣度有多重要？更多是否永遠更好，或者較少數量、但新且高度具免疫原性的（聽不清）可能更有利？

I love the science question, and I'm happy to take it and expand on it. You're asking the exact question, right, which is what makes an optimal neoantigen, how many you need. These are things that we are now looking into because we have a randomized Phase III trial.

我很喜歡這個科學問題，也很樂意回答並進一步延伸。你問的正是關鍵問題：什麼構成最佳的新抗原、以及需要多少個。這些正是我們現在正在研究的事情，因為我們已有一項隨機分派的第三期試驗。

And you need the efficacy in order to decode, go back to how many neoantigens you actually need. So in melanoma, which has several hundred neoantigen (inaudible) we know that 34 selected is enough.

你需要療效結果，才能解碼並回頭推導你實際需要多少個新抗原。因此在黑色素瘤中，因其有數百個新抗原（聽不清），我們知道挑選34個就已足夠。

We can see that roughly one out of three of them generate a T cell response, although that may be higher. Actually, we're learning that we may actually have more immunogenicity than we actually thought we did.

我們可以看到，大約每三個人中就有一個會產生 T 細胞反應，儘管這個比例可能更高。事實上，我們正在了解到，我們的免疫原性可能比原先認為的還要高。

So I'm not sure more is better because I'm not sure a hazard ratio of 0.58 or 0.51 in MITT is pretty good, against KEYTRUDA is really, really good. So would more have been better? It's hard to imagine more would have been better, but I don't know. These are things we now need to decode with our Phase III data.

所以我不確定更多是否就更好，因為我不確定在 MITT 中 0.58 或 0.51 的風險比已經相當不錯了，而相較於 KEYTRUDA 這真的、真的很好。所以更多會更好嗎？很難想像更多會更好，但我也不確定。這些都是我們現在需要用第三期數據來解碼的事情。

Jess Fye with JPMorgan.

摩根大通的 Jess Fye。

Just following up on Alex's question there, you mentioned now you have this sort treasure trove of Phase III data. If I recall from the Phase II of the translational work we saw at ASCO, there were like seven patients to work with, and it was like maybe a little hard to draw conclusions based on the small sample size.

延續剛才 Alex 的問題，你提到你們現在擁有某種第三期數據的寶庫。如果我沒記錯，在我們於 ASCO 看到的第二期轉譯研究中，可用的病人好像只有七位，因此基於這麼小的樣本量可能有點難下結論。

Do you have the actual like samples and data that you need to run that analysis to figure out those answers about sort of optimal number of neoantigens?

你們是否已經有實際的樣本和所需數據來進行分析，以找出關於最佳新抗原數量之類問題的答案？

Jess, so the seven patients that you talk about is correct, the n=7. Because in order to do very deep immunological monitoring, you have to withdraw a decent amount of blood, and not all patients are willing to do that. And in this case, there were seven patients willing to do that.

Jess，你提到的七位病人是正確的，也就是 n=7。因為要做非常深入的免疫學監測，你必須抽取相當多的血液，而不是所有病人都願意這麼做。在這個案例中，有七位病人願意這麼做。

We do have more patients available from across the trials. So that's point number one. And secondly, we have developed really exciting novel ways to decode T cell reactivity from gene, from just looking at the expression data from the cold blood gene analysis TCR beta. We have a way that we're beginning to learn to try to decode back neoantigen specificity. I mean that's part of the Holy Grail.

我們確實在各項試驗中有更多病人可用。這是第一點。第二，我們已經開發出非常令人振奮的新方法，可以從基因層面、僅透過觀察冷凍血液基因分析的表達數據（TCR beta）來解讀 T 細胞反應性。我們正在學習如何回推解碼新抗原特異性。我的意思是，這是聖杯的一部分。

So I am hopeful that we will be able to get insights from the Phase III that we didn't have in the Phase II. I think that it remains to be seen how far we can go, but that is certainly the goal.

所以我抱持希望，我們能從第三期獲得在第二期所沒有的洞見。我認為我們能走多遠仍有待觀察，但這確實是目標。

Luca Issi with RBC.

RBC 的 Luca Issi。

Congrats on all the progress. Maybe, David, one more on RCC and the upcoming Phase II. Can you just maybe talk about the stratification strategy there? It looks like you're stratifying patients by either clear cell versus populari histology as well as by high versus low-disease risk.

恭喜你們取得所有進展。David，或許再問一個關於 RCC 與即將到來的第二期試驗。你能否談談那裡的分層策略？看起來你們是依透明細胞與乳頭狀組織學分型，以及高風險與低風險疾病風險來對病人分層。

I guess what I'm trying to ask is, are there any specific subpopulations within RCC that are maybe more immunologically active that you're more optimistic that this approach can work?

我想問的是，在 RCC 裡是否有任何特定亞族群可能在免疫學上更活躍，讓你們更樂觀認為這種方法可行？

Or do you think this can work kind of across the board? And then maybe related to it, are you tracking the blinded event (inaudible) and death? And are they on track with internal expectations or not?

或者你認為這可能在各個族群都能奏效？另外可能相關的是，你們是否在追蹤盲態事件（聽不清）以及死亡？它們是否符合內部預期進度？

And then maybe separately, Steve, any update on the ongoing conversations with the FDA and the time line for COVID plus flu in the US?

另外，Steve，能否更新一下與 FDA 的持續溝通情況，以及在美國 COVID 加流感的時間表？

Yes. In terms of the tracking of the events, we don't comment on that. In terms of the what subpopulations, I think we believe this can work in multiple subpopulations.

是的。就事件追蹤而言，我們不予評論。至於哪些亞族群，我想我們相信這可以在多個亞族群中奏效。

I think that was one of the insights we made from the Phase II and the Phase III studies, that pretty much all of the subsets we looked at have had a trend or a point estimate in favor of intismeran, including high-stage versus low-stage, high-TMB versus low-TMB. Some subtypes, papillary renal cell, obviously, is different than clear-cell RCC, but that's why we're stratifying against that.

我認為這是我們從第二期與第三期研究得到的洞見之一：基本上我們所看的所有子集，都呈現出有利於 intismeran 的趨勢或點估計，包括高分期對低分期、高 TMB 對低 TMB。某些亞型，例如乳頭狀腎細胞癌，顯然與透明細胞 RCC 不同，但這也是我們為何要針對這點進行分層。

But as long as they have neoantigens we think that can generate novel T cell clones, and that can potentially have a benefit. So I don't think I would narrow down to a population right now.

但只要它們具有我們認為能產生新型 T 細胞克隆的新抗原，就可能帶來效益。所以我認為我目前不會把範圍縮小到某一特定族群。

Just on the question on the flu/COVID combo vaccine for the US. We, as we said before, we are waiting for the approval in August. That was just two months ago, and then the launch of the flu and COVID vaccines in the US.

關於美國的流感/COVID 聯合疫苗問題。正如我們之前所說，我們正在等待 8 月的核准。那只是兩個月前，接著是在美國推出流感與 COVID 疫苗。

And that was our key to then start the process of engaging with the FDA, that will take some time, there's a lot going on right now across our whole portfolio. And so we will, in the next number of months, be able to sit down and understand better what the US FDA expects in terms of submission of the 1083 program. And once we have that information, we'll obviously provide an update.

而那是我們啟動與 FDA 接洽流程的關鍵，這會需要一些時間，因為我們整個產品組合目前有很多事情在進行。因此，在接下來幾個月內，我們將能坐下來更清楚了解美國 FDA 對於 1083 計畫提交所期待的內容。一旦我們掌握該資訊，我們當然會提供更新。

Ladies and gentlemen, this does conclude the Q&A portion of today's program. I'd like to turn the call back over to Stephane for any further remarks.

各位女士先生，今天節目的問答部分到此結束。我想把電話交回給 Stephane，請他做進一步的結語。

Well, thank you, everybody, for joining us today. We really appreciate it. We're looking forward to seeing many of you in person next week for our Annual Analyst Day, November 12. And we are very excited for you to tour and to discover the intismeran manufacturing site. Have a nice weekend.

好的，謝謝各位今天加入我們。我們非常感謝。我們期待下週在 11 月 12 日的年度分析師日與許多各位面對面見面。我們也非常期待各位參觀並探索 intismeran 的製造基地。祝各位週末愉快。

Thank you. Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.

謝謝。各位女士先生，今天的簡報到此結束。感謝各位的參與。您現在可以斷線，祝您有美好的一天。