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Operator
Operator
Good day and thank you for standing by. Welcome to the Revolution Medicine's Q2 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.
您好,感謝您的支持。歡迎參加 Revolution Medicine 2025 年第二季財報電話會議。(操作員指示)請注意,今天的會議正在錄音。
I would now like to hand the conference over to your first speaker today, Ryan Asay, SVP of Corporate Affairs. Please go ahead.
現在,我想將會議交給今天的第一位發言人,企業事務資深副總裁 Ryan Asay。請繼續。
Ryan Asay - Senior Vice President - Corporate Affairs
Ryan Asay - Senior Vice President - Corporate Affairs
Thank you, and welcome everyone to the second-quarter 2025 earnings call. Joining me on today's call are Dr. Mark Goldsmith, Revolution Medicine's Chairman and Chief Executive Officer; and Jack Anders, our Chief Financial Officer. Dr. Steve Kelsey, our President of R&D; Anthony Mancini, our Chief Global Commercialization Officer; and Peg Horn, our Chief Operating Officer, will join us for the Q&A portion of today's call.
謝謝大家,歡迎大家參加 2025 年第二季財報電話會議。參加今天電話會議的還有 Revolution Medicine 董事長兼首席執行官馬克·戈德史密斯博士和首席財務官傑克·安德斯。我們的研發總裁 Steve Kelsey 博士、我們的全球首席商業化長 Anthony Mancini 和我們的營運長 Peg Horn 將參加今天電話會議的問答環節。
I'd like to inform you that certain statements we make during this call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the US Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended June 30, 2025 and recent corporate updates. The press release is available on the Investor section of our website at revmed.com.
我想告訴大家,我們在這次電話會議中所做的某些聲明將具有前瞻性。由於此類陳述涉及未來事件,並受許多風險和不確定性的影響,實際結果可能與前瞻性陳述中的結果有重大差異。有關這些風險和不確定性的全面討論,請查看我們向美國證券交易委員會提交的 10-K 表年度報告和 10-Q 表季度報告。今天下午,我們發布了截至 2025 年 6 月 30 日的季度財務表現和最新的公司更新。新聞稿可在我們網站 revmed.com 的投資者部分查閱。
With that, I'll turn the call over to Dr. Mark Goldsmith, our Chairman and Chief Executive Officer. Mark?
說完這些,我將把電話轉給我們的董事長兼執行長馬克‧戈德史密斯博士。標記?
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thanks, Ryan. It's good to be with you this afternoon. Today, I'll highlight the progress we've made this quarter with a look ahead to the strategic priorities and milestones on the horizon for RevMed. I'll then pass the call over to Jack, who will provide a financial summary before I share closing remarks and open the call for questions and answers.
謝謝,瑞安。很高興今天下午能和你在一起。今天,我將重點介紹我們本季的進展,並展望 RevMed 未來的策略重點和里程碑。然後,我會將電話轉給傑克,他將提供一份財務摘要,然後我會發表結束語並開始問答環節。
At RevMed, we remain steadfast in our commitment to revolutionizing treatment for patients with RAS-addicted cancers through the discovery, development, and global delivery of innovative targeted medicines. We have a compelling pipeline of three distinguished clinical-stage RAS(ON) inhibitors. Daraxonrasib, a groundbreaking RAS(ON) multi-selective inhibitor; elironrasib, a differentiated G12C selective covalent inhibitor; and zoldonrasib, a groundbreaking G12D selective covalent inhibitor for which a full report was published recently in Science. describing the innovative chemistry, mechanism of action, and biological impact of this unique RAS(ON) inhibitor and preclinical cancer models.
在 RevMed,我們堅定不移地致力於透過發現、開發和全球提供創新的標靶藥物來徹底改變 RAS 成癮癌症患者的治療方法。我們擁有三種傑出的臨床階段 RAS(ON) 抑制劑的引人注目的產品線。Daraxonrasib,一種突破性的 RAS(ON) 多選擇性抑制劑;elironrasib,一種差異化的 G12C 選擇性共價抑制劑;zoldonrasib,一種突破性的 G12D 選擇性共價抑制劑,其完整報告最近發表在《科學》雜誌上。描述了這種獨特的 RAS(ON) 抑制劑和臨床前癌症模型的創新化學、作用機制和生物學影響。
We are executing well and making meaningful progress in advancing all of these programs, which we believe have the potential to transform treatment for patients living with RAS-driven cancers. Starting with our efforts in pancreatic cancer, daraxonrasib is our most advanced clinical program. We were pleased to announce recently that daraxonrasib received Breakthrough Therapy designation from the US Food and Drug Administration in previously treated metastatic pancreatic cancer with KRAS G12 mutations.
我們在推進所有這些項目方面執行良好並取得了有意義的進展,我們相信這些項目有可能改變 RAS 驅動癌症患者的治療方法。從我們在胰臟癌領域的努力開始,daraxonrasib 是我們最先進的臨床課程。我們最近很高興地宣布,daraxonrasib 獲得了美國食品藥物管理局頒發的突破性療法認定,用於治療先前接受過治療的 KRAS G12 突變轉移性胰腺癌。
This designation underscores the large unmet medical needs for patients living with pancreatic cancer and the urgency of advancing development of daraxonrasib on behalf of patients. Toward this objective, we continue to make progress across our active and planned daraxonrasib registrational studies in pancreatic cancer. First, RASolute 302, our ongoing global Phase 3 trial in patients with second-line metastatic pancreatic ductal adenocarcinoma, or PDAC, has been enrolling well, and we expect to complete enrollment this year to enable an expected data readout in 2026.
此項認定凸顯了胰臟癌患者龐大未滿足的醫療需求,以及代表患者推動 daraxonrasib 開發的迫切性。為了實現這一目標,我們將繼續在胰腺癌領域正在進行的和計劃中的 daraxonrasib 註冊研究中取得進展。首先,我們正在進行的針對二線轉移性胰腺導管腺癌(PDAC)患者的全球 3 期試驗 RASolute 302 的招募工作進展順利,我們預計今年將完成招募工作,以便在 2026 年獲得預期的數據讀數。
Notably, with robust contributions by US investigational sites to date, we are winding down enrollment in the US while continuing to enroll patients outside the US to ensure we have a reasonable geographic mix to support global registration. Second, we continue progressing toward initiating our first-line metastatic pancreatic cancer registrational trial, which we plan to conduct as a three-armed trial, comparing daraxonrasib or daraxonrasib plus chemotherapy to chemotherapy.
值得注意的是,由於迄今為止美國研究中心的大力貢獻,我們正在逐步減少在美國的招募,同時繼續招募美國以外的患者,以確保我們擁有合理的地理組合來支持全球註冊。其次,我們繼續推進一線轉移性胰腺癌註冊試驗的啟動,我們計劃進行一項三臂試驗,比較 daraxonrasib 或 daraxonrasib 加化療與化療。
Later this year, we expect to share the trial design and clinical combination data that informed this plan and to initiate the trial. Third, we also continue progressing toward a registrational trial with daraxonrasib as adjuvant treatment for patients with resectable PDAC. And later this year, we expect to share the trial design and initiate this trial as well.
今年晚些時候,我們預計將分享該計劃的試驗設計和臨床組合數據並啟動試驗。第三,我們也將繼續推進 daraxonrasib 作為可切除 PDAC 患者輔助治療的註冊試驗。今年晚些時候,我們預計將分享試驗設計並啟動這項試驗。
For patients with pancreatic cancer specifically bearing a RAS G12D mutation, the clinical activity and tolerability profile we've reported for zoldonrasib is quite encouraging and suggests it is a remarkable inhibitor of this common cancer driver. We continue to follow patients in the ongoing monotherapy trial and are currently studying several combination treatments, including as part of a RAS(ON) inhibitor doublet with daraxonrasib, in combination with standard-of-care regimens and with other novel targeted agents.
對於患有 RAS G12D 突變的胰腺癌患者,我們報告的 zoldonrasib 的臨床活性和耐受性概況非常令人鼓舞,並表明它是這種常見癌症驅動因素的卓越抑制劑。我們將繼續追蹤正在進行的單一療法試驗中的患者,目前正在研究幾種聯合療法,包括作為 RAS(ON) 抑製劑與 daraxonrasib 的雙聯療法的一部分,與標準治療方案聯合使用以及與其他新型標靶藥物聯合使用。
For example, for patients with pancreatic cancers carrying both a RAS mutation and deletion of MTAP, Tango Therapeutics announced that a first patient was dosed in a collaborative Phase 1 trial evaluating their PRMT5 inhibitor TNG 462 with either daraxonrasib or zoldonrasib. Such novel combinations have the potential to provide differentiated options for patients with these cancer genotypes.
例如,對於攜帶 RAS 突變和 MTAP 缺失的胰腺癌患者,Tango Therapeutics 宣佈在合作 1 期試驗中對第一位患者進行了給藥,以評估其 PRMT5 抑製劑 TNG 462 與 daraxonrasib 或 zoldonrasib 的療效。這種新穎的組合有可能為具有這些癌症基因型的患者提供差異化的選擇。
Moving to non-small cell lung cancer, RASolute 301, our Phase 3 trial of daraxonrasib in previously treated patients with RAS mutant non-small cell lung cancer, continues enrolling patients in the US, and we are now activating trial sites in Europe and Japan as planned. Evaluating daraxonrasib in earlier lines of therapy for patients with non-small cell lung cancer is also an area of strategic priority for RevMed.
轉向非小細胞肺癌,我們對接受過 RAS 突變型非小細胞肺癌治療的患者進行的 daraxonrasib 第 3 階段試驗 RASolute 301 正在美國繼續招募患者,目前我們正在按計劃啟動歐洲和日本的試驗地點。評估 Daraxonrasib 對非小細胞肺癌患者早期治療的效果也是 RevMed 的策略重點領域。
We recently showed clinical evidence that daraxonrasib can be combined productively and tolerably with pembrolizumab with or without platinum-doublet chemotherapy. With these results in hand, we're working toward initiating a registrational trial in first-line non-small cell lung cancer in 2026 and expect to share the trial design in connection with the initiation.
我們最近展示了臨床證據,表明達拉松拉西布可以與派姆單抗有效且耐受地聯合使用,無論是否聯合鉑雙藥化療。有了這些結果,我們正致力於在 2026 年啟動一線非小細胞肺癌的註冊試驗,並希望在啟動時分享試驗設計。
Clinical development efforts also continue across our RAS(ON) mutant selective inhibitors, elironrasib and zoldonrasib in patients with RAS G12C or G12D non-small cell lung cancer, respectively. First, we recently reported an updated clinical data set from patients with previously treated KRAS G12C non-small cell lung cancer treated with elironrasib as monotherapy that showed a highly competitive profile, including differentiated safety and tolerability, along with a compelling objective response rate and progression-free survival.
我們也將繼續針對 RAS(ON) 突變選擇性抑制劑 elironrasib 和 zoldonrasib 進行臨床開發工作,分別針對 RAS G12C 或 G12D 非小細胞肺癌患者。首先,我們最近報告了先前接受過治療的 KRAS G12C 非小細胞肺癌患者的最新臨床數據集,這些患者使用 elironrasib 作為單一療法進行治療,顯示出高度競爭力,包括差異化的安全性和耐受性,以及令人信服的客觀反應率和無進展生存期。
We recently announced that elironrasib was granted Breakthrough Therapy designation by the FDA for locally advanced or metastatic KRAS, G12C, non-small cell lung cancer following prior systemic therapy, including anti-PD-1 and chemotherapy. This designation is a recognition of the significant unmet medical need and elironrasib's potential to serve these patients. Currently, there are no RAS-targeted inhibitors with full FDA approval for treating patients with KRAS G12C non-small cell lung cancer.
我們最近宣布,elironrasib 被 FDA 授予突破性療法認定,用於治療局部晚期或轉移性 KRAS、G12C、非小細胞肺癌,先前已接受過全身性治療,包括抗 PD-1 和化療。這個頭銜是對重大未滿足的醫療需求以及 elironrasib 為這些患者服務的潛力的認可。目前,尚無針對 RAS 的抑制劑獲得 FDA 的全面批准,用於治療 KRAS G12C 非小細胞肺癌患者。
Second, we also recently expanded the clinical evidence supporting the potential benefit of combining elironrasib with other inhibitors. In particular, the RAS(ON) inhibitor doublet of elironrasib and daraxonrasib were shown to exhibit significant anti-tumor activity in advanced non-small cell lung cancer patients who had progressed on treatment with a KRAS G12C OFF inhibitor. This observation mirrored similar findings that we had previously reported in patients with KRAS G12C colorectal cancer.
其次,我們最近也擴大了支持將 elironrasib 與其他抑制劑結合使用的潛在益處的臨床證據。尤其是 RAS(ON) 抑制劑雙聯體 elironrasib 和 daraxonrasib,在接受 KRAS G12C OFF 抑制劑治療後病情出現進展的晚期非小細胞肺癌患者中表現出顯著的抗腫瘤活性。這項觀察結果與我們先前在 KRAS G12C 結直腸癌患者中報告的類似發現相似。
Third, we showed clinical evidence that elironrasib can be combined productively with pembrolizumab in first-line non-small cell lung cancer patients with an acceptable safety and tolerability profile. These findings suggest that elironrasib in various treatment configurations warrants evaluation in patients with RAS G12C non-small cell lung cancer, and we continue work to prioritize among the multiple options for advancing development of this differentiated RAS(ON) G12C inhibitor.
第三,我們展示了臨床證據,證明 elironrasib 可與 pembrolizumab 有效聯合用於一線非小細胞肺癌患者,且具有可接受的安全性和耐受性。這些發現表明,各種治療方案中的 elironrasib 值得在 RAS G12C 非小細胞肺癌患者中進行評估,我們將繼續努力在多種選擇中確定優先順序,以推進這種差異化 RAS(ON) G12C 抑制劑的開發。
Fourth, we continue to advance zoldonrasib for patients with RAS G12D non-small cell lung cancer. We recently shared promising data for patients with previously treated RAS G12D non-small cell lung cancer. We are following these patients and enrolling an expansion cohort to generate a robust data set. We are also evaluating its potential in combination settings to inform potential registration opportunities.
第四,我們繼續推進 zoldonrasib 用於治療 RAS G12D 非小細胞肺癌患者。我們最近分享了針對先前接受過治療的 RAS G12D 非小細胞肺癌患者的有希望的數據。我們正在追蹤這些患者並招募擴展隊列以產生可靠的數據集。我們也正在評估其在組合設定中的潛力,以提供潛在的註冊機會。
We were pleased to announce recently a new clinical collaboration with Summit Therapeutics to evaluate combinations of Summit's ivonescimab, an advanced PD-1 VEGF bispecific antibody with each of daraxonrasib, elironrasib, and zoldonrasib. This collaboration builds on promising initial clinical evidence we have reported, indicating that daraxonrasib and elironrasib can deliver additive antitumor activity with an acceptable safety and tolerability profile when combined with a PD-1 antibody.
我們很高興最近宣布與 Summit Therapeutics 建立新的臨床合作,以評估 Summit 的 ivonescimab(一種先進的 PD-1 VEGF 雙特異性抗體)與 daraxonrasib、elironrasib 和 zoldonrasib 的組合。此次合作建立在我們已報告的有希望的初步臨床證據之上,表明 daraxonrasib 和 elironrasib 與 PD-1 抗體結合使用時可以提供附加的抗腫瘤活性,並具有可接受的安全性和耐受性。
The new cohorts will assess whether combinations with a next-generation PD-1 VEGF bispecific inhibitor can unlock further therapeutic impact. Beyond our first three clinical stage RAS(ON) inhibitors that are progressing nicely, the next asset we are preparing to enter clinical development is RMC-5127, a RAS(ON) G12V selective inhibitor. We expect this program to be clinic ready later this year to support the planned initiation of a Phase 1 trial in 2026.
新的隊列將評估與下一代 PD-1 VEGF 雙特異性抑制劑的組合是否能夠釋放進一步的治療效果。除了我們前三個臨床階段進展順利的 RAS(ON) 抑制劑之外,我們準備進入臨床開發的下一個資產是 RMC-5127,一種 RAS(ON) G12V 選擇性抑制劑。我們預計該計畫將於今年稍後投入臨床,以支持計劃於 2026 年啟動的第一階段試驗。
And we continue investing to produce next-generation assets to build on our momentum and support our commitment to creating the leading global RAS-targeted franchise. Among these investments are collaborations that will enhance our discovery efforts. This includes our work with Athon announced last year to discover novel bispecific antibodies that can complement RAS(ON) inhibitors.
我們將繼續投資生產下一代資產,以增強我們的發展勢頭並支持我們致力於創建全球領先的 RAS 目標特許經營權的承諾。這些投資包括將增強我們的發現力度的合作。這包括我們去年與 Athon 合作宣布的發現補充 RAS(ON) 抑制劑的新型雙特異性抗體。
We also recently announced a significant drug discovery collaboration with Iambic to use their cutting-edge AI capabilities and generate customized models through training with our proprietary data. This work may be particularly impactful by enhancing our lead discovery and optimization processes directed against both current and new drug targets. This exciting collaboration brings together AI, and our well-validated drug discovery capability to help ensure that we continue building a highly impactful and sustainable pipeline.
我們最近也宣布與 Iambic 進行一項重要的藥物研發合作,利用他們先進的人工智慧能力,並透過利用我們的專有資料進行訓練來產生客製化模型。這項工作可能透過增強我們針對目前和新藥物目標的先導藥物發現和優化過程產生特別大的影響。此次令人興奮的合作將人工智慧和我們經過充分驗證的藥物發現能力結合在一起,以幫助確保我們繼續建立具有高度影響力和可持續性的管道。
The progress I've outlined today is enabled by a strong operational foundation and the capabilities, talent, and financial wherewithal needed to scale the efforts to meet the ever-growing opportunities afforded by our pipeline. Our position of financial strength has been meaningfully bolstered by our recently announced partnership with Royalty Pharma.
我今天概述的進展得益於強大的營運基礎以及擴大努力以滿足我們管道所提供的不斷增長的機會所需的能力、人才和財力。我們最近宣布與 Royalty Pharma 建立合作夥伴關係,這大大增強了我們的財務實力。
This partnership supplements our strong balance sheet by providing us with an additional $2 billion in committed capital through a highly flexible mix of synthetic royalty and debt instruments, which are available to us upon achievement of agreed-upon milestones. This capital access gives us the firepower, autonomy, and strategic agility we need to advance our ambitious clinical development and commercialization plans.
此次合作透過高度靈活的合成特許權使用費和債務工具組合為我們提供額外的 20 億美元承諾資本,補充了我們強勁的資產負債表,這些資本可在我們實現商定的里程碑後使用。這種資本管道為我們提供了推動雄心勃勃的臨床開發和商業化計劃所需的火力、自主權和戰略敏捷性。
Importantly, it also provides the financial muscle behind the commitment we announced for RevMed to direct and execute independently on a global development and commercialization strategy for our promising RAS-targeted portfolio. This financial strength, combined with our maturing pipeline and organizational capabilities, empower our intention to become a fully integrated global oncology company that discovers, develops, and delivers innovative, targeted therapies on behalf of patients worldwide living with RAS-addicted cancers.
重要的是,它還為我們宣布的承諾提供了財務支持,即 RevMed 將獨立指導和執行我們有前景的 RAS 目標產品組合的全球開發和商業化策略。這種財務實力,加上我們日趨成熟的產品線和組織能力,使我們有志於成為一家完全整合的全球腫瘤學公司,為全球患有 RAS 成癮性癌症的患者發現、開發和提供創新的標靶療法。
I'd now like to turn the call over to Jack to provide more specifics on our Royalty Pharma partnership and summarize our second=quarter results. Jack?
現在我想將電話轉給傑克,讓他提供更多關於我們與 Royalty Pharma 合作的細節,並總結我們第二季的表現。傑克?
Jack Anders - Chief Financial Officer
Jack Anders - Chief Financial Officer
Thanks, Mark. Before I turn into the second-quarter financial results, I would like to review a few key highlights from our Royalty Pharma transaction. This funding arrangement provides for $2 billion in committed funding comprised of up to $1.25 billion in synthetic royalty on future sales of daraxonrasib and up to $750 million in corporate debt. We have structured the funding arrangement to be flexible, with $1.25 billion or almost two-thirds reserved as optional for RevMed and to be drawn at our election, subject to the achievement of specific milestones.
謝謝,馬克。在介紹第二季財務表現之前,我想回顧一下 Royalty Pharma 交易中的幾個關鍵亮點。這項融資安排提供了 20 億美元的承諾資金,其中包括高達 12.5 億美元的 daraxonrasib 未來銷售合成特許權使用費以及高達 7.5 億美元的公司債務。我們已將資金安排設計得十分靈活,其中 12.5 億美元(即近三分之二)作為可選資金保留給 RevMed,並由我們根據具體里程碑的實現情況進行選擇。
This innovative funding provides us with flexible access to $2 billion in committed capital at a competitive cost and without equity dilution to our shareholders or compromising control of our clinical assets. We expect to use this financial flexibility as we progress our programs, as our cash flow and capital needs evolve, and as we continue optimizing our capital formation strategy as the company and portfolio mature. Additional details on our Royalty Pharma partnership can be found in our filings with the SEC.
這項創新融資使我們能夠以具有競爭力的成本靈活地獲得 20 億美元的承諾資本,並且不會稀釋股東的股權或損害我們對臨床資產的控制權。我們希望在專案推進、現金流量和資本需求變化以及公司和投資組合成熟時繼續優化資本形成策略的過程中利用這種財務靈活性。有關我們與 Royalty Pharma 合作的更多詳細信息,請參閱我們向美國證券交易委員會 (SEC) 提交的文件。
Moving to our financials, we ended the second quarter of 2025 with $2.1 billion in cash and investments. This balance includes the receipt of the first royalty monetization tranche of $250 million from our partnership with Royalty Pharma. Turned into expenses, R&D expenses for the second quarter of 2025 were $224.1 million compared to $134.9 million for the second quarter of 2024.
談到我們的財務狀況,截至 2025 年第二季度,我們擁有 21 億美元的現金和投資。餘額包括我們與 Royalty Pharma 合作收到的第一筆 2.5 億美元特許權使用費貨幣化款項。轉化為費用,2025 年第二季的研發費用為 2.241 億美元,而 2024 年第二季的研發費用為 1.349 億美元。
The increase in R&D expenses was primarily due to increases in our clinical trial-related expenses and manufacturing expenses for our three clinical stage programs, with daraxonrasib being the largest driver of the increase given the program is in two Phase 3 trials. Personnel-related expenses and stock-based compensation expense also increased in 2025 due to additional headcount.
研發費用的增加主要是由於我們的三個臨床階段項目的臨床試驗相關費用和製造費用的增加,其中daraxonrasib是成長的最大驅動力,因為該項目目前處於兩個 3 期試驗階段。由於員工人數增加,2025 年人事相關費用和股票薪酬費用也將增加。
G&A expenses for the second quarter of 2025 were $40.6 million compared to $21.7 million for the second quarter of 2024. The increase in G&A expenses was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount and commercial preparation activities. Net loss for the second quarter of 2025 was $247.8 million compared to $133.2 million for the first quarter of 2024. The increase in net loss was primarily driven by higher operating expenses.
2025 年第二季的 G&A 費用為 4,060 萬美元,而 2024 年第二季為 2,170 萬美元。一般及行政費用的增加主要是由於與增加員工人數和商業準備活動相關的人事相關費用和股票薪酬費用的增加。2025 年第二季淨虧損為 2.478 億美元,而 2024 年第一季淨虧損為 1.332 億美元。淨虧損的增加主要是因為營業費用增加所致。
With regard to the accounting for the Royalty Pharma transaction, the first $250 million royalty monetization tranche we received in June was accounted for as a liability on our second-quarter balance sheet. This liability will accrete or increase through interest expense on our income statement, and future royalty payments we pay on net sales of daraxonrasib will be applied against and reduce the liability balance on our balance sheet. In the second quarter of 2025, we recognized approximately $900,000 in non-cash interest expense related to the transaction and expect this to grow for the remainder of the year.
關於 Royalty Pharma 交易的會計處理,我們在 6 月收到的第一筆 2.5 億美元特許權使用費貨幣化款項在我們第二季的資產負債表中被記為負債。此負債將透過我們損益表中的利息費用累積或增加,並且我們根據 daraxonrasib 淨銷售額支付的未來特許權使用費將用於抵銷並減少我們資產負債表上的負債餘額。2025 年第二季度,我們確認了與該交易相關的約 90 萬美元的非現金利息支出,預計今年剩餘時間內這一數字還會增長。
We are updating our 2025 financial guidance and expect projected full-year 2025 GAAP net loss to be between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million. The increase in expected GAAP net loss is primarily the result of our decision to pursue global development and commercialization independently, and increased expenses that result from our growing confidence related to our robust research, development, and commercialization plans.
我們正在更新 2025 年財務指引,預計 2025 年全年 GAAP 淨虧損將在 10.3 億美元至 10.9 億美元之間,其中包括估計 1.15 億美元至 1.3 億美元的非現金股票薪酬費用。預期 GAAP 淨虧損的增加主要是因為我們決定獨立進行全球開發和商業化,以及由於我們對強大的研發和商業化計劃的信心不斷增強而導致的費用增加。
That concludes the financial update. I'll now turn the call back over to Mark.
財務更新到此結束。我現在將電話轉回給馬克。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thank you, Jack. The Revolution Medicines organization is determined to build the leading global targeted medicines franchise for patients living with RAS-addicted cancers. We believe our strong financial condition and access to a large quantum of additional capital to fuel our expansive development and commercialization plans for our compelling portfolio of investigational drugs will empower us to establish new global standards of care for patients living with RAS-addicted pancreatic, lung, and colorectal cancers.
謝謝你,傑克。Revolution Medicines 組織致力於為患有 RAS 成癮性癌症的患者打造全球領先的標靶藥物特許經營權。我們相信,我們強大的財務狀況和獲得大量額外資本的機會將推動我們針對引人注目的試驗藥物組合的廣泛開發和商業化計劃,這將使我們能夠為患有 RAS 成癮性胰腺癌、肺癌和結直腸癌的患者建立新的全球護理標準。
Our momentum is made possible by the support of our patients and caregivers, clinical investigators, scientific and business collaborators, advisors, and shareholders. I'd also like to recognize the continuing extraordinary efforts of RevMed employees, whose tireless commitment to patients drives this progress.
我們的動力得益於病人和照護者、臨床研究人員、科學和商業合作者、顧問和股東的支持。我還要感謝 RevMed 員工的持續非凡努力,他們對病人的不懈奉獻推動了這項進步。
This concludes our prepared remarks, and I'll now turn the call over to the operator for the Q&A session.
我們的準備好的演講到此結束,現在我將把電話交給接線員進行問答環節。
Operator
Operator
(Operator Instructions) Michael Schmidt, Guggenheim Securities.
(操作員指示)古根漢證券的邁克爾施密特。
Michael Schmidt - Analyst
Michael Schmidt - Analyst
Hey, good afternoon. Thanks for taking my questions. And yes, nice to hear that the RASolute 302 study is winding down US sites. Mark, could you comment on how you're tracking towards completing enrollment at ex-US, and perhaps any comments on the rough geographic distribution of patients would be interesting, I think.
嘿,下午好。感謝您回答我的問題。是的,很高興聽到 RASolute 302 研究正在逐步結束美國的研究。馬克,您能否評論一下您在美國以外地區完成註冊的進展情況,並且我認為,關於患者大致地理分佈的任何評論都會很有趣。
And then a question on the planned first-line PDAC study where you sort of reaffirmed plans to run a three-arm study here. And obviously, a lot of interest in the chemotherapy combination where you're doing work still, obviously with the goal to optimize durability and I believe maintaining dose intensity here. How important is potentially clinical efficacy assessment for these chemotherapy combinations to support advancing one or perhaps more of these plant combinations into first line? Thanks so much.
然後是關於計劃中的一線 PDAC 研究的一個問題,您重申了在此進行三組研究的計劃。顯然,人們對您正在進行的化療組合非常感興趣,顯然是為了優化耐久性,我相信可以保持劑量強度。這些化療組合的潛在臨床療效評估對於支持將一種或多種植物組合推進到第一線治療有多重要?非常感謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thank you, Michael. Those were meaty, meaty questions. So the first question is about 302. It is making very good progress. I don't think we can share with you a breakdown of actual distribution. That, of course, continues to evolve. As indicated, we're winding down the US enrollment. There continues to be enrollment outside the United States, and so the final numbers will ultimately be determined by that.
謝謝你,麥可。這些都是非常有意義的問題。所以第一個問題是關於 302 的。目前進展非常好。我認為我們無法與您分享實際分佈的細目。當然,這種情況還在持續發展中。正如所指出的,我們正在逐步減少美國的招生。美國境外的招生仍在繼續,因此最終的數字將由境外的招生情況決定。
But it's hard to give you much more information than that. We're sort of like landing a Navy jet on a moving aircraft carrier. There's a lot of parts that all have to synchronize to get to the finish line. It's looking very solid. We're in very good shape, and I think we'll be in a good position to share data in 2026.
但很難向您提供更多資訊。我們就像讓一架海軍噴射機降落在一艘行駛中的航空母艦上。有很多部分必須同步才能到達終點。它看起來非常堅固。我們的狀況非常好,我認為到 2026 年我們將能夠很好地共享數據。
With regard to the three-arm study and the chemo combination component, I think you asked sort of two subparts. One is, are we still studying it? And then the second was, what role does efficacy play as a parameter in that? Steve, do you want to comment on each of those questions? Are we still studying chemo combinations, and what role does efficacy play?
關於三組研究和化療組合部分,我認為您問的是兩個子部分。一是我們還在研究它嗎?第二點是,功效作為參數在其中扮演什麼角色?史蒂夫,你想對每個問題發表評論嗎?我們還在研究化療組合嗎?療效起什麼作用?
Steve Kelsey - President - Research and Development
Steve Kelsey - President - Research and Development
We are still studying the chemo combinations, but we did promise that we would share the study design and the rationale behind that study design in 2025. We're getting closer to the end of 2025, so you can infer that we're pretty close to the end of the assessments that we need in order to inform the study design specifically.
我們仍在研究化療組合,但我們承諾將在 2025 年分享研究設計及其背後的原則。我們越來越接近 2025 年底,因此你可以推斷,我們已經非常接近完成需要的評估,以便具體指導研究設計。
With regards to the efficacy assessments explicitly, of course, they will be important in informing the study design up to a point. The primary basis for the ongoing assessments that we have is obviously safety and tolerability. We are relying very heavily on the second-line data that we have for daraxonrasib, which as we have previously reported, seems to exceed the outcomes for chemotherapy in first-line pancreatic cancer.
當然,就功效評估而言,它們在某種程度上對於研究設計具有重要意義。我們正在進行的評估的主要依據顯然是安全性和耐受性。我們非常依賴 daraxonrasib 的二線數據,正如我們之前報告的那樣,該藥物的療效似乎超過了胰腺癌一線化療的結果。
So that's already a fairly strong driver of our decision to move forwards with that study. But there will be some supplementary efficacy information for the analyses that we've done, specifically in first-line patients. And we will share that information when we share the study design as part of the rationale. I hope that we'll have a pretty comprehensive package and a persuasive one for you at that time.
所以這已經成為我們決定繼續進行這項研究的相當強大的驅動力。但對於我們所做的分析,特別是針對第一線患者,將會有一些補充療效資訊。當我們分享研究設計作為基本原理的一部分時,我們也會分享這些資訊。我希望到時候我們能為您提供一個相當全面且具說服力的方案。
Michael Schmidt - Analyst
Michael Schmidt - Analyst
Very helpful. Thank you so much.
非常有幫助。太感謝了。
Operator
Operator
Marc Frahm, TD Cowen.
馬克·弗拉姆(Marc Frahm),TD Cowen。
Marc Frahm - Analyst
Marc Frahm - Analyst
Thanks for taking my questions. And mostly following on Michael's questions, hopefully as meaty. Could you maybe characterize the chemotherapies you're zeroing in on and how closely you'd expect that to the chemo in the combination to resemble kind of a standard-of-care first-line regimen versus maybe how much you've had to dose adjust to make things tolerable? And then on the guidance for data potentially being in 2026 for a second-line trial, is that referring to the final analysis, or is that inclusive of where you're projecting all of the interims to occur as well?
感謝您回答我的問題。並且主要回答麥可的問題,希望內容豐富。您能否描述一下您所關注的化療,以及您認為聯合化療與標準一線治療方案的相似程度以及您可能需要調整多少劑量才能使病情可以忍受?然後,關於 2026 年可能進行的二線試驗的數據指導,這是指最終分析,還是包括您預測的所有中期分析?
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Okay, thanks, Mark. I appreciate the questions. The first question, remind me again, had to do with chemotherapy -- the regimens, yes. As we've indicated, I know we've talked about this with you before, that all of the dosing that we're looking at is well within standard practice. We're not pushing outside of that at all, nor do we think we're going to need to do that. So I think we're using very active doses.
好的,謝謝,馬克。我很感謝你們提出這些問題。再次提醒我一下,第一個問題與化療有關——是的,治療方案。正如我們所指出的,我知道我們之前已經與您討論過這個問題,我們正在研究的所有劑量都符合標準做法。我們根本沒有推動這一點,我們也不認為我們需要這樣做。所以我認為我們使用的是非常有效的劑量。
And within chemo, as we've discussed before, doses that are higher at the beginning of a treatment regimen often become lower. In fact, they very typically become lower throughout the course of multiple cycles simply because they started at MTD. So by definition, they're barely tolerable, and they get less and less tolerable over time. So I think we're well within that range, and that's by intention.
正如我們之前討論過的,在化療中,治療方案開始時較高的劑量通常會變得較低。事實上,它們通常在多個週期的過程中變得更低,只是因為它們從 MTD 開始。所以根據定義,它們幾乎無法忍受,而且隨著時間的推移,它們會變得越來越無法忍受。所以我認為我們完全處於這個範圍內,而且這是我們有意為之。
The second question had to do with when we say a readout of data in 2026, what do we mean? Well, I mean, all we can really reference right now is the first analysis. We can't really predict what would happen at that time. It all depends. That first analysis might be the final analysis. It might be an interim analysis. And there are potential additional analyses after that. But they're all event driven. And so we don't really control the timing. So it would be very hard to tell you all possible scenarios here.
第二個問題是,當我們說 2026 年的數據讀數時,我們的意思是什麼?嗯,我的意思是,我們現在真正可以參考的只是第一個分析。我們真的無法預測到那時會發生什麼。一切都取決於情況。第一次分析可能是最終分析。這可能是一個中期分析。此後還可能進行額外的分析。但它們都是事件驅動的。所以我們其實無法控制時間。因此,在這裡很難告訴您所有可能的情況。
Marc Frahm - Analyst
Marc Frahm - Analyst
Okay, but it is the first interim that's likely in 2026, given kind of current event rates and enrollment rates?
好的,但考慮到目前的事件發生率和入學率,這可能是 2026 年的第一次中期選舉?
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Well, we can't skip the first interim. The first analysis is always going to be the first out analysis, and we do think there will be a report in 2026. And we're optimistic that we'll be able to deliver on that. The enrollment has been very robust, as we're indicating here, and we're having to sort of slow some things down to allow other things to fill those slots. I don't think that enrollment is going to be an issue at all.
好吧,我們不能跳過第一個中期。第一次分析總是最早得出的分析,我們確實認為 2026 年會有一份報告。我們樂觀地認為我們能夠實現這一目標。正如我們在此指出的,報名人數非常多,我們不得不放慢一些事情的進度,以便讓其他事情來填補這些空缺。我認為入學根本不是一個問題。
We just then have to let the events -- and a reminder that this is an OS event-driven readout. Even though it will read all the endpoints, it's OS driven. And we can't really predict that, even though we have models that attempt to predict it, but we don't know for sure. I think we're comfortable with 2026.
我們只需要讓事件發生——並提醒這是一個作業系統事件驅動的讀數。儘管它將讀取所有端點,但它是由作業系統驅動的。我們無法真正預測這一點,儘管我們有模型試圖預測這一點,但我們並不確定。我認為我們對 2026 年感到滿意。
Marc Frahm - Analyst
Marc Frahm - Analyst
Okay. Thank you.
好的。謝謝。
Operator
Operator
Jonathan Chang, Leerink Partners.
Jonathan Chang,Leerink Partners。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
Hi, guys. Thanks for taking my question. On the daraxonrasib combination data informing the frontline PDAC registrational study design, can you provide any additional color on what kind of data and how much data we can expect later this year? Thank you.
嗨,大家好。感謝您回答我的問題。關於為一線 PDAC 註冊研究設計提供資訊的 daraxonrasib 組合數據,您能否提供更多關於我們今年稍後可以期待什麼類型的數據和多少數據的資訊?謝謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thanks, Jonathan. I think the best way to answer that, and Steve, you may want to add to this, is we are building a data set that allows us to make these decisions. And that's usually our standard. If it's sufficient information to guide our decision making, to give us confidence in moving forward, to spend significant capital, and to commit patients to experimental arms at a trial, then we feel that that's sufficient to share with you. And that's all we can do to quantitate it at this point.
謝謝,喬納森。我認為回答這個問題的最好方法是,史蒂夫,你可能想補充一點,我們正在建立一個資料集,以便我們做出這些決定。這通常是我們的標準。如果這些資訊足以引導我們的決策,讓我們有信心繼續前進,投入大量資金,並讓患者接受試驗的實驗組,那麼我們認為這些資訊足以與您分享。這就是我們目前所能做的全部量化工作。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
Got it. Maybe just one follow up on that then. Can you provide your latest thoughts on what you think the key considerations are as we think about which chemo regimen or regimens could be part of that front-line daraxonrasib registrational study? Thank you.
知道了。那麼也許只需跟進一次即可。當我們考慮哪種化療方案或哪些化療方案可以成為第一線 Daraxonrasib 註冊研究的一部分時,您能否提供您最新的想法,您認為關鍵的考慮因素是什麼?謝謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Well, I think Steve may want to comment on it and reiterate, but it's primarily a safety and dose intensity question. We can give you a little bit more color to that, but that's always been the question that we needed to resolve as we discussed starting back at the first conference of the year. Chemotherapy, I'll just say one more thing, and then Steve can clarify it here.
嗯,我想史蒂夫可能想對此發表評論並重申,但這主要是安全性和劑量強度問題。我們可以為您提供更多細節,但這始終是我們需要解決的問題,正如我們在今年第一次會議開始討論的那樣。化療,我只想再說一件事,然後史蒂夫可以在這裡澄清一下。
Chemotherapy is dosed at an actual tolerated dose, so anything you add to that may end up compromising not only the dosing of the chemotherapy, but also the dosing of the active target agent as well. And since we believe generally continuous dosing is a very good idea for suppressing RAS pathway signaling and thereby suppressing inhibiting tumor growth, we need to optimize that. So that really is the main consideration, but maybe Steve can give you --
化療的劑量是按照實際耐受劑量計算的,因此添加的任何藥物最終不僅會影響化療的劑量,還會影響活性標靶藥物的劑量。由於我們認為持續給藥對於抑制 RAS 路徑訊號傳導並從而抑制腫瘤生長是一個非常好的想法,因此我們需要對其進行最佳化。所以這確實是主要考慮因素,但也許史蒂夫可以給你--
Steve Kelsey - President - Research and Development
Steve Kelsey - President - Research and Development
That was the primary -- the primary consideration was the minimizing dose interruptions and maximizing the dose intensity of the RAS inhibitor. We fundamentally believe that pancreatic cancer is a RAS-driven disease and that the best treatment you can deploy would be a RAS inhibitor. And so it's really important for us that the patients that are randomized to get the RAS inhibitor get the best chance on that RAS inhibitor, which means that the dose intensity has to be as high as possible, and the interruptions need to be as infrequent and as short as possible.
這是主要的——主要的考慮是盡量減少劑量中斷並儘量提高 RAS 抑制劑的劑量強度。我們從根本上相信胰臟癌是一種由 RAS 驅動的疾病,而您可以採用的最佳治療方法是使用 RAS 抑制劑。因此,對我們來說,讓隨機接受 RAS 抑制劑治療的患者獲得最佳治療機會非常重要,這意味著劑量強度必須盡可能高,且中斷次數必須盡可能少且盡可能短。
And chemotherapy, unfortunately, does a very good job of disrupting both of those things. So chemotherapy will cause toxicities that require dose interruptions of the RAS inhibitor, and chemotherapy may result in other things happen that may ultimately reduce the dose intensity of the RAS inhibitor. Having said that, there are some critical constraints. We're not testing regimens that are unusual. We're not testing cytotoxic drugs that are not used in standard practice on a global basis, and we're not testing the schedules or doses of those drugs that are not used in standard practice on a global basis.
不幸的是,化療會嚴重破壞這兩種功能。因此,化療會引起毒性,需要中斷 RAS 抑制劑的劑量,且化療可能會導致其他情況發生,最終降低 RAS 抑制劑的劑量強度。話雖如此,但仍存在一些關鍵的限制。我們不會測試不尋常的療法。我們不會測試全球範圍內未在標準實踐中使用的細胞毒性藥物,我們也不會測試全球範圍內未在標準實踐中使用的藥物的時間表或劑量。
So I think that, ultimately, we have a few constraints. This is going to be a global trial. We have consulted very widely across the major geographic areas that will be participating in this study, and I think that we will come up with a solution that is acceptable for everyone involved. As I say, once we've dotted the Is and crossed the Ts, we would be very happy to share that information with you. We're just not quite ready right now to do that.
所以我認為,最終我們面臨一些限制。這將是一次全球試驗。我們已經對參與這項研究的主要地理區域進行了廣泛的諮詢,我相信我們將找到一個所有相關人員都能接受的解決方案。正如我所說,一旦我們把一切都做好,我們將非常樂意與您分享這些資訊。我們現在還沒有做好準備。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
For disclosure, but we are very optimistic about this and we've repeated this plan multiple times now, and it will be the plan.
為了披露,但我們對此非常樂觀,我們已經多次重複了這個計劃,這將是計劃。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
Understood. Thank you.
明白了。謝謝。
Operator
Operator
Ellie Merle, UBS.
瑞銀的艾莉·梅爾(Ellie Merle)。
Ellie Merle - Analyst
Ellie Merle - Analyst
Hey, guys, thanks so much for taking the question and congrats on all the progress. I'm curious your perspective on RAS upregulation as a resistance mechanism and thoughts on RAS degradation versus inhibition, particularly in the G12D space. Thanks.
嘿,夥計們,非常感謝你們提出這個問題,並祝賀你們取得的所有進展。我很好奇您對 RAS 上調作為抵抗機制的看法,以及對 RAS 降解與抑制的看法,特別是在 G12D 領域。謝謝。
Steve Kelsey - President - Research and Development
Steve Kelsey - President - Research and Development
Yes, RAS amplification is a real issue. So firstly, let's start with -- I don't think it matters whether it's all about G12D or not, frankly, because I think what I'm going to say is going to likely to be true for all of the major RAS mutations and probably all of the major tumors in which RAS is a cancer driver. But RAS amplification, that is amplification of the mutant allele, the actual KRAS G12D, if you like, for G12D driven tumors, is a major force of escape from RAS inhibitors. Because the tumors really, really love RAS and they try everything they possibly can to continue to signal through RAS.
是的,RAS 擴增是一個真正的問題。首先,讓我們從——坦率地說,我認為這是否與 G12D 有關並不重要,因為我認為我要說的很可能適用於所有主要的 RAS 突變,甚至可能適用於 RAS 作為癌症驅動因素的所有主要腫瘤。但 RAS 擴增,即突變等位基因的擴增,對於 G12D 驅動的腫瘤來說,實際的 KRAS G12D 是逃避 RAS 抑制劑的主要力量。因為腫瘤真的非常喜歡 RAS,它們會盡一切可能繼續透過 RAS 發出訊號。
If you give a mutant-selected inhibitor, there are multiple other ways the tumor can escape by reactivating RAS. But if you give a RAS multi-inhibitor, a lot of those additional pathways are shut down, and the tumor ultimately has to default to RAS amplification. The problem for the tumor is that mutant RAS amplification is unfavorable for the tumor. It takes a lot of energy for the tumor to do it. It takes quite a long time for the upregulation to become apparent and for the translation of the protein to actually overcome the RAS inhibitor. And there are also therapeutic ways where you can get on top of RAS amplification.
如果給予突變選擇抑制劑,腫瘤可以透過多種其他方式透過重新激活 RAS 逃脫。但如果你使用 RAS 多重抑制劑,許多額外的途徑就會關閉,腫瘤最終必須預設進行 RAS 擴增。腫瘤的問題在於突變的RAS擴增對腫瘤不利。腫瘤要做到這一點需要耗費大量的能量。上調需要相當長的時間才能顯現,並且蛋白質的翻譯才能真正克服 RAS 抑制劑。而且還有一些治療方法可以讓你控制 RAS 擴增。
If you double down on inhibition of the mutant RAS allele with, for instance, a RAS(ON) doublet, which we're clinically testing right now, you can actually get over the mutant RAS allele amplification. So yes, we acknowledge that it's a problem. It seems to be more of a problem for RAS multi-inhibition than it is for mutant-selected inhibitors. And there are therapeutic ways of getting on top of it. And some of them we have in our discovery toolbox, and we just haven't shared them publicly yet.
如果您加倍抑制突變 RAS 等位基因,例如使用我們目前正在進行臨床測試的 RAS(ON) 雙聯體,您實際上可以克服突變 RAS 等位基因的擴增。是的,我們承認這是一個問題。對於 RAS 多重抑制來說,這似乎比對於突變選擇抑制劑更成問題。並且有治療方法可以解決它。其中一些我們已經保存在我們的發現工具箱中,只是還沒有公開分享。
With regards to degraders versus inhibitors, I don't think there's any evidence anywhere in the global literature for any oncology target that a degrader is better than an inhibitor. And I think that the jury will remain out until the degrader companies generate clinical data that exceeds the efficacy and safety of the inhibitors that we have currently in clinical development. I can't comment more than that. I just don't see any precedent right now for the degrade of technology being superior to inhibitors.
關於降解劑與抑制劑,我認為全球文獻中沒有任何證據表明任何腫瘤學標靶的降解劑優於抑制劑。我認為,直到降解劑公司提供的臨床數據超過我們目前在臨床開發中的抑制劑的功效和安全性之前,陪審團都不會做出裁決。我無法發表更多評論。我只是現在沒有看到任何先例表明技術的退化優於抑制劑。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Ellie, thanks for that question. And just to highlight a point that Steve made, the tumor is a microcosm of natural selection. And so it's actually gratifying to see that these RAS-addicted tumors go to such great lengths to overcome deraxonerasib. It's because it's such an effective inhibitor of RAS and they're so dependent upon RAS. So I think it makes complete sense biologically. We believe it makes complete sense biologically and is a marker of how effective daraxon really is on suppressing broadly the RAS pathway.
艾莉,謝謝你的提問。為了強調史蒂夫提出的觀點,腫瘤是自然選擇的縮影。因此,看到這些 RAS 成癮腫瘤竭盡全力克服 deraxonerasib,我們確實感到欣慰。這是因為它是一種非常有效的 RAS 抑制劑,而且它們非常依賴 RAS。所以我認為這從生物學上來說是完全合理的。我們相信這在生物學上是完全合理的,並且是 Daraxon 在廣泛抑制 RAS 路徑方面的有效性的標誌。
Ellie Merle - Analyst
Ellie Merle - Analyst
Thank you.
謝謝。
Operator
Operator
Kelly Shi, Jefferies.
傑富瑞 (Jefferies) 的凱莉施 (Kelly Shi)。
Kelly Shi - Analyst
Kelly Shi - Analyst
Congrats on the progress and thank you for taking my questions. For the front-line pancreatic cancer trial, as you guided, you shared a pivotal trial design later this year. Curious, at this moment, if the trial design has been signed off by the regulatory agencies. Could we assume no interim data from second-line pivotal trials needed in the data package will sign off based on the comments made from the opening remarks? Thank you.
恭喜您的進展,感謝您回答我的問題。對於一線胰臟癌試驗,正如您所指導的,您在今年稍後分享了一項關鍵的試驗設計。目前令人好奇的是,試驗設計是否已經獲得監管機構的批准。根據開場白中的評論,我們是否可以假設資料包中所需的二線關鍵試驗的中期數據都不會被簽署?謝謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thank you, Kelly. We don't typically give sort of blow-by-blow updates on our interactions with the regulatory agencies. It ends up being much less helpful than one might hope for. So I can't really answer that specific question. But I think what's lost here a little bit is, although it's not yet transparent to our investors, to our analysts, we're actually making very good progress. The fact that we keep reiterating that we're going to be on timeline for initiating is an indicator of where we stand. But beyond that, we just can't give you any higher-resolution insight into it. It's coming soon enough. Days go by quickly.
謝謝你,凱利。我們通常不會詳細地介紹我們與監管機構的互動。最終它的作用遠沒有人們所希望的那麼大。所以我實際上無法回答這個具體問題。但我認為,這裡稍微失去的是,儘管對我們的投資者和分析師來說還不透明,但我們實際上正在取得非常好的進展。事實上,我們不斷重申我們將按時啟動,這表明了我們的立場。但除此之外,我們無法為您提供任何更高解析度的見解。它很快就來了。日子過得很快。
Kelly Shi - Analyst
Kelly Shi - Analyst
Okay, thanks.
好的,謝謝。
Operator
Operator
Andrea Newkirk, Goldman Sachs.
高盛的安德里亞紐柯克 (Andrea Newkirk)。
Andrea Newkirk - Analyst
Andrea Newkirk - Analyst
Good afternoon. Thanks for taking the question. Maybe just given the reiterated timelines here for expected enrollment completion for RASolute, the top-line data next year launched to follow in '27, just curious if you'd be willing to speak more on the extent to which you're already engaging in pre-commercial activities and what learnings you're taking from LUMAKRAS or KRAZATI launches that you see to be applicable to the upcoming daraxonrasib launch in PDAC. Thanks so much.
午安.感謝您回答這個問題。也許只是考慮到這裡重申的 RASolute 預計完成註冊的時間表,明年推出的頂線數據將在 27 年跟進,只是好奇您是否願意更多地談談您已經參與商業化前活動的程度,以及您從 LUMAKRAS 或 KRAZATI 的發布中獲得了哪些經驗,您認為這些經驗適用於即將在 PDACDAC 推出的 daraxonrasib。非常感謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thanks, Andrea. Just to clarify, I don't think we've guided to commercial dates. We have guided to data in 2026. I'm not agreeing or disagreeing with that particular date but just clarifying that we've not guided to anything about the commercial timeline. With that said, Anthony Mancini can give us his view of our commercialization program status.
謝謝,安德里亞。需要澄清的是,我認為我們還沒有指導商業日期。我們已經指導了2026年的數據。我既不同意也不反對那個特定的日期,只是想澄清一下,我們還沒有對商業時間表做出任何指導。話雖如此,安東尼·曼奇尼可以向我們介紹我們商業化計畫的現狀。
Anthony Mancini - Chief Global Commercialization Officer
Anthony Mancini - Chief Global Commercialization Officer
Thanks for the question, Andrea. And thanks, Mark. I think what I'll say is that launch readiness plans are progressing very well. We've got a team of experienced and talented executives leading our commercialization team across medi fairs, market access, marketing, and sales, and they're deeply engaged in market-shaping activities and planning and in KOL and advocacy organization engagement, and in really building our operational capabilities and launch readiness activities.
謝謝你的提問,安德里亞。謝謝你,馬克。我想說的是,發射準備計畫進展非常順利。我們擁有一支經驗豐富、才華橫溢的高階主管團隊,領導我們的商業化團隊,負責醫療展會、市場准入、行銷和銷售,他們深入參與市場塑造活動和規劃、KOL 和倡導組織的參與,並真正致力於建立我們的營運能力和發布準備活動。
And an example of some of the market shaping work that's going on is our Expect RAS campaign that's focused on educating the community oncologists primarily that RAS is a driver mutation in PDAC and that over 90% of pancreatic cancers have RAS mutations. We're continuing to add to that experienced and talented team and starting to build our US field teams more broadly now.
我們正在進行的一些市場塑造工作的一個例子是我們的「預期 RAS」活動,該活動的重點是教育社區腫瘤學家,主要了解 RAS 是 PDAC 中的驅動突變,並且超過 90% 的胰腺癌都有 RAS 突變。我們正在繼續擴充這支經驗豐富、才華橫溢的團隊,並開始更廣泛地建立我們的美國實地團隊。
We're learning from some of the other launches, not just the G12 OFF inhibitors, and putting the right resources in the right place, building the best strategies and tactics and operational capabilities so that we bring daraxonrasib with urgency to patients when we when we get that opportunity. And we're confident in our ability to continue to hire the right talent with the right commercialization experience, both in the US and internationally.
我們正在從其他一些新產品中學習,而不僅僅是 G12 OFF 抑制劑,並將正確的資源放在正確的地方,制定最佳的策略、戰術和營運能力,以便當我們有機會時,能夠緊急地將 Daraxonrasib 帶給患者。我們有信心,我們有能力繼續在美國和國際上聘用具有適當商業化經驗的合適人才。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thanks, Anthony. And maybe I could just add a comment. Sort of observing it, as Anthony builds that organization, I think we're going to give this a really strong effort. And hopefully, we'll have a terrific approval that will go with it and great label when the time comes.
謝謝,安東尼。也許我可以添加一條評論。從某種程度上觀察,隨著安東尼建立該組織,我認為我們將為此付出真正的巨大努力。希望到時候我們能獲得極好的批准和極好的標籤。
Operator
Operator
Jay Olson, Oppenheimer.
傑伊·奧爾森,奧本海默。
Jay Olson - Analyst
Jay Olson - Analyst
Hey, congrats on all the progress and thanks for providing this update. We have a question about your Summit partnership. And since you're planning to combine ivonescimab with all three of your RAS(ON) inhibitors, can you just talk about how you're going to prioritize those three combinations, and especially with regards to which tumor types you would prioritize. And then I have a follow up. Thank you.
嘿,祝賀您取得的所有進展,並感謝您提供此更新。我們對您的 Summit 合作關係有一個疑問。既然您計劃將 ivonescimab 與所有三種 RAS(ON) 抑制劑結合使用,您能否談談如何優先考慮這三種組合,特別是關於您優先考慮哪些腫瘤類型。然後我有一個後續行動。謝謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thanks, Jay. I can't really give you much information about that. That's sort of an operational question more than anything. We continue with our commitment to pembrolizumab. As you know, we've talked about things that we'll continue to do with pembrolizumab, which is the really singular standard in first-line lung cancer, in particular, and also in many other indications. But in parallel, we'll begin exploring how the bispecific antibody will behave jointly with these different agents. And I'm sure they'll be studied across a variety of solid tumors.
謝謝,傑伊。我實在無法提供你太多有關此方面的資訊。這首先是一個操作問題。我們將繼續致力於 pembrolizumab 的研究。如您所知,我們已經討論了我們將繼續對派姆單抗進行的研究,派姆單抗是治療一線肺癌的真正獨特標準,並且在許多其他適應症中也是如此。但同時,我們將開始探索雙特異性抗體如何與這些不同的藥物共同發揮作用。我確信它們將在多種實體腫瘤中進行研究。
Initially with dose escalations, we typically start with a wide net because we're trying to establish safety initially. And then over time, once we get past any safety questions, then we start focusing on very specific indications. Too hard today in this context and at this stage to outline any of those more specific paths beyond the dose escalation. But we're excited to be in the collaboration. We think it takes essentially the most advanced VEGF PD-1 bispecific antibody in the field with the richest pipeline of RAS(ON) inhibitors. But put them together, and we think that's a very, very promising opportunity.
最初增加劑量時,我們通常從大範圍開始,因為我們試圖先建立安全性。隨著時間的推移,一旦我們解決了所有安全問題,我們就會開始關注非常具體的跡象。在這種背景下,目前階段很難概述除劑量增加之外的任何更具體的途徑。但我們很高興能夠參與此次合作。我們認為它本質上是該領域最先進的 VEGF PD-1 雙特異性抗體,具有最豐富的 RAS(ON) 抑制劑產品線。但把它們結合起來,我們認為這是一個非常非常有希望的機會。
Jay Olson - Analyst
Jay Olson - Analyst
Okay. Thank you for that. And then, I guess, as you look into the future, do you think the combination of ivonescimab plus the daraxonrasib has the potential to be an ideal combination in first-line non-small cell lung cancer?
好的。謝謝你。然後,我想,展望未來,您是否認為 ivonescimab 加 daraxonrasib 的組合有可能成為一線非小細胞肺癌的理想組合?
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Ideal? Ideal is a fairly big word. I don't know. There will always be things that we'll continue to try to improve upon whatever is the then-standard. But it stands a chance of becoming a new standard, of having differentiated impact. In the meantime, while we're doing that work, ivonescimab, in other contexts, will see more mature data as Summit and their partner elaborate that information. And so we'll get a better sense of how it performs relative to PD-1. The initial information is encouraging, but it's hard for us to see in the future. This work for us is being done on the presumption that it will play out, and we're excited to see more options, more opportunities, more potential benefit for patients.
理想的?理想是一個相當大的字。我不知道。無論當時的標準是什麼,我們總是會不斷嘗試改進一些事情。但它有可能成為一種新標準,並產生差異化的影響。同時,在我們進行這項工作的同時,隨著 Summit 及其合作夥伴詳細闡述這些信息,ivonescimab 在其他情況下將獲得更成熟的數據。因此我們將更了解它相對於 PD-1 的表現。初步的資訊令人鼓舞,但我們很難預見未來。我們是在假設它會成功的基礎上進行這項工作的,我們很高興看到為患者提供更多的選擇、更多的機會和更多的潛在利益。
Jay Olson - Analyst
Jay Olson - Analyst
Excellent. We'll look forward to that. Thanks for taking the questions.
出色的。我們對此充滿期待。感謝您回答這些問題。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thank you.
謝謝。
Operator
Operator
Ami Thadia, Needham and Company.
阿米·薩迪亞,李約瑟公司。
Poorna Kannan - Analyst
Poorna Kannan - Analyst
Hi, this is Poorna on for Ami. Thank you for taking our question. I'm just wondering, for the data update that's expected in 2026 for RASolute 302, is there any scenario where, with the data update, you could seek some sort of accelerated approval, and what would that look like? And the second question is a follow up on the Tango Therapeutics one. Could you elaborate on how the combination of RAS(ON) inhibitor with PD-1 and VEGF innovator can improve response and efficacy in RAS tumors? Thank you.
大家好,我是 Poorna,為 Ami 服務。感謝您回答我們的問題。我只是想知道,對於預計在 2026 年進行的 RASolute 302 數據更新,是否存在可以透過數據更新尋求某種加速批准的場景,以及具體是什麼樣的?第二個問題是 Tango Therapeutics 問題的後續。您能詳細說明 RAS(ON) 抑制劑與 PD-1 和 VEGF 創新劑的結合如何改善 RAS 腫瘤的反應和療效嗎?謝謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Sure. Yes, so the first, thanks for your question. The first question is, do we envision the possibility of an accelerated approval? I think we're kind of -- that might mix up a couple of different things. I mean, there's an accelerated approval pathway, which has -- my friend Steve Kelsey often points out it's not often the most accelerated approval pathway. It's just called accelerated approval because you can submit a different data set.
當然。是的,首先感謝您的提問。第一個問題是,我們是否預見到加速核准的可能性?我認為我們有點——這可能會混淆一些不同的東西。我的意思是,有一個加速批准途徑,我的朋友史蒂夫凱爾西經常指出,這通常不是最快的批准途徑。這被稱為加速批准,因為您可以提交不同的資料集。
We're going to have a complete data set. That's the whole point of the randomized control trial and the progress that's being made now. And we expect to have a package of data in 2026. So then the question is, how fast can they move on it as opposed to will they -- will we pursue an accelerated approval path, I think just to differentiate those, and we'll move as fast on it as we can. And we hope they'll move as fast on it as they can.
我們將擁有一套完整的資料集。這就是隨機對照試驗的全部意義以及目前正在取得的進展。我們預計在 2026 年會獲得一包資料。那麼問題是,他們能以多快的速度採取行動,而不是——我們是否會採取加速審批的途徑,我認為只是為了區分它們,我們會盡快採取行動。我們希望他們能盡快採取行動。
But beyond that, I don't think we can speculate today about timing. We, of course, are preparing ourselves to move as absolutely as sufficiently as possible. When we do open the envelope and see what the data show us, there won't be any hesitation on our part to move those data forward. We'll be well prepared for it. It will be a well-oiled machine. And hopefully, by then, we will also set things up with the FDA to maximize their ability to move as well.
但除此之外,我認為我們今天無法推測時間。當然,我們正在做好準備,盡可能充分地採取行動。當我們打開信封並看到資料顯示的內容時,我們會毫不猶豫地將這些資料轉發出去。我們將做好充分準備。這將是一台運作良好的機器。希望到那時,我們也能與 FDA 達成一致,最大限度地提高他們的行動能力。
And I guess the other comment would be that the BTD does create some efficiencies or some speed in the review process that we'll take advantage of. And so that's a benefit of having BTD in our hands. I think that's about all I can probably say on that. Yes, okay, and then the bispecific, what was the question on it? It was -- yes. Dr. Wei Lin is with us, our Chief Medical Officer. And maybe he wants to comment on PD-1, with and without VEGF, and why there's the possibility that it adds incremental value.
我想另一條評論是,BTD 確實在審核過程中提高了一些效率或速度,我們可以利用這一點。這就是我們擁有 BTD 的好處。我想這就是我能說的全部了。是的,好的,那麼雙特異性的問題是什麼?是的——是的。我們的首席醫療官魏林博士也和我們在一起。也許他想評論 PD-1(無論是否有 VEGF),以及為什麼它有可能增加增量價值。
Wei Lin - Chief Medical Officer
Wei Lin - Chief Medical Officer
Yes, sure. Thanks for the question. Thanks, Mark. Historically, if you reference back to, say, EGFR, which RAS is a downstream node from EGFR, the combination of target therapy using EGFR protocols plus VEGF, there's actually crosstalk between these pathways that there's actually an improvement in both response rates as well as progression-free survival. There's been a number of trials actually demonstrated that. Now that has to improve itself in RAS, but at least, in theory, there could be interaction between those two pathways that can enhance anti-tumor activity and potentially even translate to improved progression-free survival.
是的,當然。謝謝你的提問。謝謝,馬克。從歷史上看,如果你回顧一下,比如說 EGFR,其中 RAS 是 EGFR 的下游節點,使用 EGFR 方案加 VEGF 的靶向治療相結合,這些途徑之間實際上存在串擾,從而實際上提高了反應率和無進展生存期。事實上已經有大量試驗證明了這一點。現在,RAS 必須改善,但至少在理論上,這兩種途徑之間可能存在相互作用,從而增強抗腫瘤活性,甚至可能轉化為改善無惡化存活期。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Yes, and to add to that, I mean, we've already demonstrated, albeit with a relatively early data set, but we've already demonstrated that the RAS inhibitors, both daraxonrasib and elironrasib, in combination with an anti-PD-1, do deliver a greater punch, at least as determined by response rates. We didn't present any durability data. And we've seen that many times in preclinical models.
是的,此外,我的意思是,儘管數據集相對較早,但我們已經證明,RAS 抑製劑 daraxonrasib 和 elironrasib 與抗 PD-1 相結合確實能產生更大的效果,至少從反應率來看是這樣。我們沒有提供任何耐用性數據。我們在臨床前模型中已經多次看到這種情況。
Particularly, the RAS(ON) inhibitors are so effective at suppressing the RAS pathway that they reverse some of the local immunosuppressive effects that occur inside a RAS-driven tumor, and that makes them more sensitive to the impact of an anti-PD-1 antibody when it unleashes the immune response.
特別是,RAS(ON) 抑制劑在抑制 RAS 路徑方面非常有效,它們可以逆轉 RAS 驅動腫瘤內部發生的一些局部免疫抑製作用,這使得它們對抗 PD-1 抗體引發免疫反應時的影響更加敏感。
So that additivity, we think, is already there. Whether the VEGF itself contributes -- the VEGF antagonist contributes to RAS-driven signaling versus just tumor growth, I don't think we can dissect that out. But it's a reasonable bet that if the bispecific antibody is superior to the monospecific PD-1 antibody, then when you combine it with RAS, it'll be superior to the monospecific PD-1 antibody combined with the RAS inhibitor. That just makes sense. But it will have to be experimentally shown.
因此我們認為,這種可加性已經存在。VEGF 本身是否有貢獻 - VEGF 拮抗劑是否有助於 RAS 驅動的信號傳導而不是僅僅有助於腫瘤生長,我認為我們無法剖析這一點。但如果雙特異性抗體優於單特異性 PD-1 抗體,那麼當將其與 RAS 結合時,它將優於與 RAS 抑制劑結合的單特異性 PD-1 抗體。這很有道理。但這必須用實驗來證明。
Poorna Kannan - Analyst
Poorna Kannan - Analyst
Great. Thank you so much.
偉大的。太感謝了。
Operator
Operator
Alec Stranaha, Bank of America.
亞歷克·斯特拉納哈,美國銀行。
Alec Stranahan - Analyst
Alec Stranahan - Analyst
Hey, guys. Thanks for taking our questions and congrats from me on the updates as well. First on zoldonrasib and elironrasib, are there any particular data points you're waiting on before pushing these into additional studies? When do you expect to have the information in hand to make that decision?
嘿,大家好。感謝您回答我們的問題,我也對這些更新表示祝賀。首先關於 zoldonrasib 和 elironrasib,在將它們推向進一步研究之前,您是否正在等待任何特定的數據點?您預計何時能夠獲得做出該決定所需的資訊?
And second, on the Iambic collaboration, how do you see your in-house data as maybe synergizing with their platform? And what kind of conclusions do you think you'll be able to draw leveraging their AI technology that I guess you wouldn't have been able to make on your own? Thank you.
其次,關於與 Iambic 的合作,您認為您的內部數據如何與他們的平台產生協同作用?您認為利用他們的人工智慧技術您能夠得出什麼樣的結論?我猜您自己是無法得出這些結論的?謝謝。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thanks a lot, Alec. Zoldon and eliron, you're looking for sort of what data packet will impact our decision-making? Well, we have those studies really already underway, and they've been well-described. And we've, in some cases, shown relatively small early datasets that are quite encouraging. And we believe those datasets, but of course, we continue to follow patients to make sure that there aren't latent tolerability or safety signals. So that's one of the things we do. We often expand then to make sure we have enough data to convince the FDA or regulatory bodies and so on.
非常感謝,亞歷克。Zoldon 和 eliron,你們正在尋找什麼樣的資料包會影響我們的決策?嗯,這些研究我們已經在進行了,並且已經進行了詳細的描述。在某些情況下,我們展示了相對較小的早期數據集,這非常令人鼓舞。我們相信這些數據集,但當然,我們會繼續追蹤患者,以確保沒有潛在的耐受性或安全性訊號。這就是我們所做的事情之一。我們經常會進行擴展以確保我們有足夠的數據來說服 FDA 或監管機構等。
So there are quite a number of things, and there are so many different options there that it would be very difficult for us to sort of lay out a complete delineation of every study and exactly which data will be coming when and would make the difference. So therefore, we've simply not described it except when we think we're close to something where we can have a meaningful guidance about when something's going to happen. I think both zoldon and eliron are doing very well, and they do create some fantastic opportunities for us, and you can bet we're working on those. We'll just ask for patience until we're ready to give more complete stories about them.
因此,涉及的事情相當多,而且有如此多的不同選擇,因此我們很難對每項研究進行完整的描述,也很難確切地知道哪些數據將在何時出現以及會產生什麼影響。因此,我們只是沒有描述它,除非我們認為我們已經接近某件事,並且我們可以對某件事何時會發生提供有意義的指導。我認為 zoldon 和 eliron 都表現得非常好,它們確實為我們創造了一些絕佳的機會,你可以打賭我們正在努力實現這些目標。我們只希望大家耐心等待,直到我們準備好提供關於他們的更完整的故事。
With regard to Iambic, yes, I think, basically, it comes down to this for us. We have tens of thousands of tri-complex inhibitors that have been carefully crafted by our amazing chemistry group with feedback and input from our cancer biology organization. That creates a massive data set around, you could call it simply SAR, but it's a massive data set.
關於抑揚格,是的,我認為,基本上,對我們來說,就是這樣。我們擁有數以萬計的三重複合物抑制劑,這些抑制劑是由我們出色的化學團隊根據癌症生物學組織的回饋和意見精心開發的。這會建立一個龐大的資料集,您可以簡單地將其稱為 SAR,但它是一個龐大的資料集。
Now our chemists are very familiar with it because they made all of those compounds, but it's a lot of information to keep in your head and to be able to access sort of on a moment's notice. AI has no problem with that. It accesses all of that information iteratively very, very quickly. And so the notion here is that we ought to just get more firepower out of processing that information, that multidimensional information, which accounts to, undoubtedly, many millions of data points, if not even a larger scale than that.
現在我們的化學家對此非常熟悉,因為他們製造了所有這些化合物,但需要記住的資訊很多,並且需要能夠隨時獲取。AI 對此沒有問題。它可以非常非常快速地迭代訪問所有這些資訊。所以這裡的想法是,我們應該從處理這些資訊、多維資訊中獲得更強大的火力,這些資訊無疑可以解釋數百萬個數據點,甚至比這更大的規模。
It's very large data sets across many different parameters, and it can process those and give the chemists a hand in helping to prioritize which things that are worth synthesizing and which things aren't. And Iambic in particular has used -- has built their NeuralPLexer technology to facilitate this, and they've done it on a particular scale for a particular set of goals and actually created very quickly their own lead molecule and then development candidates to take into the clinic. That's not related to RAS per se, but it sort of validated the effectiveness of their technology.
它是涵蓋許多不同參數的非常大的數據集,它可以處理這些數據集並幫助化學家確定哪些東西值得合成,哪些東西不值得合成。尤其是 Iambic 公司已經使用——已經構建了他們的 NeuralPLexer 技術來促進這一點,並且他們在特定的規模上針對特定的目標集完成了這項工作,並且實際上非常快速地創建了自己的先導分子,然後開發候選分子以進入臨床。這與 RAS 本身無關,但它在某種程度上驗證了其技術的有效性。
So they have their own uses for it, but they and we agreed that feeding that AI model or updating the AI model by incorporating our proprietary data may deliver insights that the model can predict for us or produce for us that can make it more efficient. That could be applied to RAS targets. That could be applied to non-RAS targets. We have everything from modest ambition goals to very high ambition goals. And we'll see as we prosecute this to what degree it delivers.
因此,他們有自己的用途,但他們和我們都同意,透過整合我們的專有數據來提供該人工智慧模型或更新人工智慧模型,可能會提供該模型可以為我們預測或為我們產生的見解,從而使其更有效率。這可以應用於 RAS 目標。這可以應用於非 RAS 目標。我們的目標從適度的目標到非常高的目標都有。我們將在起訴過程中看到其效果如何。
And in the meantime, we are for sure investing in our own internal AI capabilities. This is a very nice component of an overall strategy that's growing here with regard to the use of machine learning essentially, largely, but also more broadly AI to make us even better at something that our organization's already pretty good at.
同時,我們肯定會投資於我們自己的內部人工智慧能力。這是整體策略的一個非常好的組成部分,該策略主要涉及使用機器學習,但更廣泛地說,人工智慧可以使我們在組織已經非常擅長的事情上做得更好。
Alec Stranahan - Analyst
Alec Stranahan - Analyst
Thank you.
謝謝。
Operator
Operator
Peter Lawson, Barclays.
巴克萊銀行的彼得·勞森。
Peter Lawson - Analyst
Peter Lawson - Analyst
Great. Thank you. Thanks for the updates. Just a follow up on the commercial buildout, kind of how large will the US field team be, and kind of what milestones do you want to hit over the next 12 months as regards to the buildout?
偉大的。謝謝。感謝您的更新。關於商業建設的後續問題,美國現場團隊的規模有多大,以及您希望在未來 12 個月內實現哪些建設里程碑?
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Yes. Hi, Peter. Thanks for the question. I'm going to hand you over to Anthony, who may be somewhat disappointing for you on this particular point. That's sort of somewhat strategic and competitive information, but -- maybe give it a try.
是的。你好,彼得。謝謝你的提問。我要把你交給安東尼,在這一點上他可能會讓你有點失望。這有點策略性和競爭性的信息,但是——也許可以嘗試一下。
Anthony Mancini - Chief Global Commercialization Officer
Anthony Mancini - Chief Global Commercialization Officer
Thanks, Mark. And thanks, Peter, for the question. We have initiated the build out of our US field team. In fact, we already have parts of the field team in place. We have an MSL team and we have a thought leader liaison team already in place, and we've started to build the rest of our team, including our access and sales leadership. And it's really been impressive to see the caliber of talent that continues to be really interested in making our mission come true, and that's the goal. So all I'll say to fulfill Mark's point earlier is that we're really pleased with the field build and we're really pleased with our progress on launch readiness so far.
謝謝,馬克。謝謝彼得提出這個問題。我們已經開始組建美國實地團隊。事實上,我們的部分實地團隊已經到位。我們有一個 MSL 團隊和一個思想領袖聯絡團隊,我們已經開始組建團隊的其他成員,包括我們的訪問和銷售領導團隊。看到如此多的人才持續熱衷於實現我們的使命,這確實令人印象深刻,這就是我們的目標。因此,為了滿足馬克先前的觀點,我要說的是,我們對現場建設感到非常滿意,我們對迄今為止在發射準備方面取得的進展感到非常滿意。
Peter Lawson - Analyst
Peter Lawson - Analyst
Thank you so much. I realize it's difficult to talk through those. And then on the PRMT-5 combo, kind of what tumor types are you prioritizing? Is this lung versus pancreatic or broader kind of MTAP deletion?
太感謝了。我意識到談論這些事情很困難。那麼對於 PRMT-5 組合,您優先考慮哪些類型的腫瘤?這是肺與胰臟還是更廣泛的類型的 MTAP 缺失?
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Steve, do you want to comment on that?
史蒂夫,你想對此發表評論嗎?
Steve Kelsey - President - Research and Development
Steve Kelsey - President - Research and Development
Well, firstly, the current study that's ongoing is being sponsored by Tango, not by Revolution Medicines. But the overlap between MTAP deletion, which creates the susceptibility to PRMT5 inhibition and RAS mutation is largely pancreatic cancer. So the focus there is mainly on pancreatic cancer. There's about, as you know, I mean, almost pretty much all pancreatic cancer is RAS-driven. About 92% of it is, frankly, RAS-mutated.
首先,目前正在進行的研究是由 Tango 贊助的,而不是由 Revolution Medicines 贊助的。但是,MTAP 缺失(導致對 PRMT5 抑制的敏感性)和 RAS 突變之間的重疊主要是胰臟癌。因此,重點主要放在胰臟癌。如您所知,幾乎所有胰臟癌都是由 RAS 引起的。坦白說,其中約 92% 是 RAS 突變的。
And somewhere between -- depending on geography, somewhere around 20% to 25% I would say would have some form of MTAP deletion or loss of function. So it turns out that around between 20% and 25% of pancreatic cancer have both, and that would be the target population for the combination largely. The overlap, there are some RAS mutant lung cancers that also have MTAP deletion, but the numbers are a little bit smaller.
根據地理位置的不同,我認為大約有 20% 到 25% 的人會出現某種形式的 MTAP 缺失或功能喪失。因此,結果顯示大約有 20% 到 25% 的胰臟癌患者同時患有這兩種疾病,而這基本上是該組合療法的目標族群。重疊的是,有些 RAS 突變肺癌也有 MTAP 缺失,但數量稍微少一些。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Yes, if I could add, I think that Tango, I think they might use the number of 30%, something like that, and we're not disagreeing with that. It's hard to nail that down. They probably have the most information since they study that. And there are -- I'm sure they would also be quick to point out, there are other tumor types in which MTAP deletion occurs, but they're less commonly sites for which RAS mutations occur. So we don't capture them in our thinking so much, so I agree with these points
是的,如果我可以補充的話,我認為 Tango 可能會使用 30% 這樣的數字,我們並不反對這一點。很難確定這一點。自從他們研究這個以來,他們可能已經掌握了最多的資訊。而且—我相信他們也會很快指出,其他類型的腫瘤也會出現 MTAP 缺失,但它們不太容易發生 RAS 突變。所以我們並沒有在思考中捕捉它們,所以我同意這些觀點
Peter Lawson - Analyst
Peter Lawson - Analyst
Great. Thank you so much.
偉大的。太感謝了。
Operator
Operator
Thank you. I'm showing no further questions at this time. I would now like to turn it back to Mark Goldsmith for closing remarks.
謝謝。我目前沒有其他問題。現在我想請馬克‧戈德史密斯作最後發言。
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Mark Goldsmith - Chairman of the Board, President, Chief Executive Officer
Thank you, operator, and thank you to everyone for participating today and for your continued support of Revolution Medicines.
謝謝接線員,也謝謝大家今天的參與以及對 Revolution Medicines 的持續支持。
Operator
Operator
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。