CytomX Therapeutics Inc (CTMX) 2025 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeutics third quarter 2025 financial results call. Please be advised that today's call is being recorded.

    大家下午好。感謝您的耐心等待。歡迎參加 CytomX Therapeutics 2025 年第三季財務業績電話會議。請注意,今天的通話將會被錄音。

  • I would now like to hand the call over to your host for today, Chris Ogden, CytomX's Chief Financial Officer. Please go ahead.

    現在我謹將電話交給今天的主持人,CytomX 的財務長 Chris Ogden。請繼續。

  • Chris Ogden - Chief Financial Officer

    Chris Ogden - Chief Financial Officer

  • Thank you. Good afternoon, and thank you for joining us. Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov.

    謝謝。下午好,感謝各位的參與。在開始之前,我想提醒大家,在本次電話會議中,我們將發表一些前瞻性聲明。由於前瞻性陳述涉及未來,因此存在難以預測的固有不確定性和風險,其中許多風險是我們無法控制的。重要風險和不確定性已在 sec.gov 網站上向美國證券交易委員會提交的最新公開文件中列出。

  • We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise. Earlier this afternoon, we issued a press release that includes a summary of our third quarter 2025 financial results and highlights recent progress at CytomX. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release, recording of this call and our SEC filings can be found under the Investors and News section of our website. With me on the call today is Dr.

    我們不承擔因新資訊、未來發展或其他原因而更新任何前瞻性聲明的義務。今天下午早些時候,我們發布了一份新聞稿,其中包括我們 2025 年第三季財務表現的摘要,並重點介紹了 CytomX 的最新進展。我們鼓勵大家閱讀今天的新聞稿及相關資料,這些資料已提交給美國證券交易委員會。此外,新聞稿、本次電話會議的錄音以及我們向美國證券交易委員會提交的文件都可以在我們網站的「投資者與新聞」部分找到。今天和我一起參加電話會議的還有博士。

  • Sean McCarthy, CytomX' Chief Executive Officer and Chairman. Sean will provide an update on our pipeline and company progress before I cover the financials for the quarter. We will then conclude with a Q&A session.

    Sean McCarthy,CytomX 的執行長兼董事長。在我介紹本季財務數據之前,肖恩將介紹我們的產品線和公司進度。最後我們將進行問答環節。

  • With that, I'll now turn the call over to Sean.

    接下來,我將把電話交給肖恩。

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Thanks, Chris, and good afternoon, everyone. We're very pleased to be here today to provide an update on our third quarter developments and our strong continued company momentum at CytomX. I'd like to start by welcoming Rachael Lester to the team as Chief Business Officer. Rachael's broad strategic planning and business development experience will be highly valuable as we shape our pipeline and corporate development strategy towards realizing our ambition of building CytomX to commercial stage.

    謝謝克里斯,大家下午好。我們今天非常高興能在這裡向大家介紹 CytomX 第三季度的最新進展以及公司持續強勁的發展勢頭。首先,我謹歡迎 Rachael Lester 加入團隊,擔任首席商務長。Rachael 豐富的策略規劃和業務發展經驗將對我們制定產品線和企業發展策略,以實現將 CytomX 推向商業化階段的目標大有裨益。

  • Rachael is a terrific addition to a wonderful team that I'm privileged to work with every day. Our goal at CytomX is to make innovative medicines for people with cancer that are substantially more effective than currently available treatments. Our most advanced drug candidate, CX-2051, is currently focused in colorectal cancer, one of the biggest unmet needs in oncology today with more than 1.9 million new cases annually worldwide, expected to exceed 3 million by 2040. I'll refer to colorectal cancer as CRC from here on.

    Rachael的加入為我們這個優秀的團隊增添了強大的力量,我每天都很榮幸能與這個團隊合作。CytomX 的目標是為癌症患者研發出比現有療法更有效的創新藥物。我們最先進的候選藥物 CX-2051 目前專注於大腸癌的治療,這是當今腫瘤學領域最大的未滿足需求之一,全球每年新增病例超過 190 萬例,預計到 2040 年將超過 300 萬例。從現在開始,我將把大腸直腸癌簡稱為 CRC。

  • CRC is also increasing in younger patients and is the second leading cause of cancer death. Five-year survival for metastatic CRC is only 13%. At CytomX, we have used our proprietary PROBODY therapeutic platform to attack this problem in a new and different way. The PROBODY approach is a masking technology that allows us to hit cancer cells hard and with stealth, sparing normal tissues, opening up therapeutic strategies that were previously impossible. Specifically, with CX-2051, we have deployed our platform to bring the power of an antibody drug conjugate to the treatment of CRC.

    CRC在年輕患者的發生率也在上升,是癌症死亡的第二大原因。轉移性大腸直腸癌的五年存活率僅為 13%。在 CytomX,我們利用我們專有的 PROBODY 治療平台,以一種全新的方式解決這個問題。PROBODY 方法是一種掩蔽技術,它使我們能夠以隱藏的方式猛烈攻擊癌細胞,同時保護正常組織,從而開闢了以前不可能實現的治療策略。具體來說,我們利用 CX-2051 平台,將抗體藥物偶聯物的力量應用於 CRC 的治療。

  • ADCs are transforming the treatment of many cancers. There are currently more than a dozen approved in the United States, but thus far, ADCs have not broken through in CRC, a notoriously difficult cancer to treat. There's an enormous opportunity here to meaningfully impact patient lives and access a global multibillion-dollar market, and our ambition at CytomX is to build an integrated commercial stage organization around this exciting opportunity. CX-2051 is a masked PROBODY ADC targeting EpCAM.

    抗體藥物偶聯物(ADC)正在改變許多癌症的治療方式。目前美國已批准十幾種抗體藥物偶聯物(ADC),但迄今為止,ADC 尚未在結直腸癌(CRC)治療中取得突破,CRC 是一種出了名的難治性癌症。這裡蘊藏著巨大的機遇,可以對患者的生活產生有意義的影響,並進入價值數十億美元的全球市場。 CytomX 的目標是圍繞著這令人興奮的機遇,建立一個全面的商業化組織。CX-2051 是一種針對 EpCAM 的掩蔽式 PROBODY ADC。

  • This drug candidate has been intentionally designed by selecting the optimal target, tumor type and cell killing mechanism to deliver potent anticancer activity. CX-2051 is, we believe, a truly differentiated molecule being the first and only EpCAM-directed ADC in development. EpCAM is a very highly and consistently expressed target in CRC. While certain locally administered EpCAM strategies have shown promise in cancer treatment, systemic approaches have consistently failed due to toxicities in normal tissues where EpCAM is also expressed.

    該候選藥物經過精心設計,選擇了最佳標靶、腫瘤類型和細胞殺傷機制,以發揮強大的抗癌活性。我們相信,CX-2051 是一種真正與眾不同的分子,它是目前唯一正在開發的 EpCAM 標靶 ADC。EpCAM是CRC中表現非常高且穩定的標靶。雖然某些局部應用的 EpCAM 策略在癌症治療中顯示出前景,但全身性方法卻屢屢失敗,因為 EpCAM 在正常組織中也有表達,而全身性方法會產生毒性。

  • To solve this problem and realize the potential of EpCAM, CX-2051 leverages our masking strategy to reduce normal tissue binding and maximize activity within tumor tissue. The CX-2051 payload is a topoisomerase-1 inhibitor known as CAMP59, selected because of the well-established responsiveness of CRC to this mechanism of cell killing, underscored by the widespread use of irinotecan in CRC therapy. Our CX-2051 product design strategy was quickly validated with our positive interim Phase I data reported in May this year from a highly focused dose escalation study in late-stage unselected metastatic CRC.

    為了解決這個問題並實現 EpCAM 的潛力,CX-2051 利用我們的掩蔽策略來減少正常組織的結合,並最大限度地提高腫瘤組織內的活性。CX-2051 的有效載荷是一種拓樸異構酶-1 抑制劑,稱為 CAMP59,之所以選擇它,是因為 CRC 對這種細胞殺傷機制的反應已得到充分證實,伊立替康在 CRC 治療中的廣泛應用也印證了這一點。今年 5 月,我們公佈了針對晚期未選擇轉移性 CRC 患者的一項高度聚焦的劑量遞增研究的積極的 I 期中期數據,迅速驗證了我們的 CX-2051 產品設計策略。

  • This first look at data from our Phase I study demonstrated robust clinical activity and the potential, we believe, for CX-2051 to become a new standard of care in this setting. To briefly recap the data, CX-2051 demonstrated meaningful tumor reductions, including confirmed objective responses or disease control in nearly every patient as well as preliminary median progression-free survival of 5.8 months, a potentially substantial improvement over currently available treatments for late-stage CRC that provide only two to three months of benefit.

    我們從 I 期研究數據中初步觀察到了強大的臨床活性,我們相信 CX-2051 有潛力成為該領域新的治療標準。簡而言之,CX-2051 顯示出顯著的腫瘤縮小效果,幾乎每位患者均得到確認的客觀緩解或疾病控制,初步的中位無進展生存期為 5.8 個月,與目前晚期 CRC 的治療方法相比,這是一個潛在的重大改進,因為這些治療方法只能提供兩到三個月的療效。

  • Patients included in this initial data set had a median of four prior lines of therapy with all patients previously having been treated with irinotecan. Encouragingly, anticancer activity was observed across a wide range of clinical characteristics, including in patients with liver metastases and KRAS mutations. The activity we've seen across this broad late-stage patient population, together with the fact that we don't need to select the EpCAM expression in CRC suggests that CX-2051 could become a pan-CRC drug.

    此初始資料集包含的患者平均接受過四線治療,所有患者之前都接受過伊立替康治療。令人鼓舞的是,在各種臨床特徵中都觀察到了抗癌活性,包括肝轉移和 KRAS 突變患者。我們看到,CX-2051 在廣泛的晚期患者群體中表現出活性,而且我們不需要選擇 CRC 中的 EpCAM 表達,這表明 CX-2051 可能成為一種泛 CRC 藥物。

  • CX-2051 was generally well tolerated, including a notable absence of safety events such as pancreatitis and liver toxicity that have limited prior EpCAM therapies, strongly suggesting that our masking technology is working as designed. We were encouraged with the hematologic safety profile of CX-2051, which could be favorable for future chemotherapy combinations.

    CX-2051 整體耐受性良好,尤其值得注意的是,沒有胰臟炎和肝毒性等安全事件,而這些安全事件曾限制了先前的 EpCAM 療法,這強烈表明我們的掩蔽技術正在按設計發揮作用。CX-2051 的血液學安全性表現令人鼓舞,這可能有利於未來的化療合併治療。

  • The most common adverse event in early Phase I was diarrhea, a known side effect of TOPO I-based therapies such as irinotecan. We're currently focused on better characterizing and managing gastrointestinal adverse events as part of our ongoing development program. Based on these very promising initial results, we're now well into the expansion phase of the Phase I study with our next data update planned for Q1 2026.

    早期 I 期試驗中最常見的不良事件是腹瀉,這是伊立替康等 TOPO I 類藥物的已知副作用。作為我們正在進行的研發項目的一部分,我們目前正致力於更好地描述和管理胃腸道不良事件。基於這些非常有希望的初步結果,我們現在已經進入 I 期研究的擴展階段,我們計劃在 2026 年第一季發布下一次數據更新。

  • With that, let's review our progress with CX-2051 this quarter as well as next steps. In August, we announced that the CX-2051 dose expansion cohorts at the 7.2, 8.6 and 10 mg/kg doses had reached our enrollment goal of approximately 20 patients each. Since August, we've continued enrollment in the dose expansion cohorts, and we now expect total enrollment in the CX-2051 Phase I study to be about 100 patients by our planned data update in the first quarter next year. As we work towards our goal of initiating a potential registrational study for CX-2051 monotherapy in late-line CRC, we expect this expanded Phase I patient enrollment will further inform dose selection, including FDA dialogue regarding Project Optimus.

    接下來,讓我們回顧一下本季 CX-2051 的進展以及下一步計畫。8 月,我們宣布 CX-2051 劑量擴展隊列在 7.2、8.6 和 10 mg/kg 劑量下已達到我們每個隊列約 20 名患者的入組目標。自 8 月以來,我們一直在劑量擴展隊列中繼續招募患者,我們現在預計,到明年第一季計畫的數據更新時,CX-2051 I 期研究的總入組人數將達到約 100 名患者。在我們努力實現啟動 CX-2051 單藥治療晚期 CRC 的潛在註冊研究的目標之際,我們期望此次擴大的 I 期患者招募將進一步為劑量選擇提供信息,包括與 FDA 就 Optimus 項目進行的對話。

  • Additionally, given the momentum within the program, we expect to initiate a Phase Ib study with the anti-VEGF antibody, bevacizumab in the first quarter of 2026. Bevacizumab is a core component of CRC therapy across multiple lines of treatment, and we anticipate this combination data will unlock broad additional potential.

    此外,鑑於該計畫目前的進展勢頭,我們預計將於 2026 年第一季啟動抗 VEGF 抗體貝伐單抗的 Ib 期研究。貝伐珠單抗是 CRC 治療中多種治療方案的核心組成部分,我們預計這種聯合療法的數據將釋放其更廣泛的潛力。

  • Beyond CRC, we continue to see potential for CX-2051 across many other cancers where EpCAM is also expressed. Given our compelling initial results in CRC, we're currently assessing additional indications for future development, and we expect to provide an update on non-CRC indications in 2026. Now turning to CX-801, our masked interferon alpha-2b program currently being developed in combination with KEYTRUDA in advanced melanoma.

    除了 CRC 之外,我們還看到 CX-2051 在 EpCAM 也表達的許多其他癌症中也具有潛力。鑑於我們在 CRC 方面取得的令人信服的初步成果,我們目前正在評估其他適應症以進行未來的開發,並預計將於 2026 年提供非 CRC 適應症的最新資訊。現在讓我們來看看 CX-801,這是我們目前正在開發的掩蔽幹擾素 α-2b 項目,它與 KEYTRUDA 聯合用於治療晚期黑色素瘤。

  • The metastatic melanoma landscape continues to evolve rapidly as checkpoint inhibition moves to earlier-stage treatment, leaving considerable unmet need in later-stage settings. Advances are being made, for example, with cell therapy and oncolytic virus strategies, but new approaches are urgently needed. We are very excited about the potential for CX-801 in melanoma as illustrated by the positive initial biomarker data we will present at SITC this weekend.

    隨著免疫檢查點抑制劑療法逐漸應用於早期治療,轉移性黑色素瘤的治療模式仍在快速變化,晚期治療領域仍有相當大的未滿足需求。例如,細胞療法和溶瘤病毒策略正在取得進展,但迫切需要新的方法。我們對 CX-801 在黑色素瘤治療中的潛力感到非常興奮,正如我們將在本週末的 SITC 會議上展示的積極的初步生物標記數據所表明的那樣。

  • In designing CX-801, we have applied a similarly focused set of design principles as we did with CX-2051 by selecting a validated pathway, a potent effector mechanism and a focused initial clinical development path centered on clear unmet medical need. Interferon alpha-2b is a well-validated powerful immune system modulator that has previously been approved for cancer therapy, but that has been limited in use due to poor tolerability. Our masking strategy for CX-801 is highly novel and includes masks on both the cytokine domain and an Fc masking domain to really minimize activity in the periphery while directing activity towards the tumor microenvironment.

    在設計 CX-801 時,我們採用了與 CX-2051 類似的專注的設計原則,即選擇一條經過驗證的通路、一種有效的效應機制以及一條以明確的未滿足的醫療需求為中心的專注的初始臨床開發路徑。幹擾素α-2b是一種經過充分驗證的強效免疫系統調節劑,先前已獲準用於癌症治療,但由於耐受性差,其使用受到限制。我們針對 CX-801 的掩蔽策略非常新穎,包括對細胞激素結構域和 Fc 掩蔽結構域的掩蔽,以真正最大限度地減少外周活性,同時將活性引導至腫瘤微環境。

  • Conceptually, what we're aiming for here is to harness the potent ability of interferon alpha to selectively activate the tumor immune microenvironment, allowing for synergistic antitumor activity in combination with checkpoint inhibition. We treated our first patient in the CX-801 Phase I study in September last year, and we've made excellent progress thus far in the clinic. Monotherapy dose escalation has reached the fourth dose level, including multiple dose levels that exceed the approved clinical dose of unmasked interferon alpha-2b.

    從概念上講,我們的目標是利用乾擾素α的強大能力選擇性地激活腫瘤免疫微環境,從而與檢查點抑制劑聯合使用,產生協同抗腫瘤活性。去年九月,我們在 CX-801 I 期研究中治療了第一位患者,到目前為止,我們在臨床上取得了非常好的進展。單藥治療劑量遞增已達到第四劑量水平,其中包括多個劑量水平超過了未掩蔽幹擾素α-2b的核准臨床劑量。

  • Now this is important since it already suggests that masking is working as designed. Our SITC presentation this weekend encompasses biomarker data from five melanoma patients treated with monotherapy. CX-801 has been generally well tolerated through the first three dose levels and is inducing robust interferon signaling within the tumor microenvironment. Specifically, our initial data includes gene expression analysis of pre- and post-treatment patient tumor biopsies, demonstrating consistently increased expression of interferon-stimulated genes, evidence of T-cell activation and upregulation of immune checkpoint inhibitors such as -- checkpoint genes, including PD-1 and PD-L1.

    這一點很重要,因為它已經表明掩蔽功能按預期工作。我們本週末在 SITC 會議上的報告包含了五名接受單藥治療的黑色素瘤患者的生物標記數據。CX-801 在前三個劑量水準中整體耐受性良好,並且在腫瘤微環境中誘導了強烈的干擾素訊號傳導。具體來說,我們的初步數據包括對治療前後患者腫瘤活檢的基因表現分析,結果表明幹擾素刺激基因的表達持續增加,T 細胞活化的證據以及免疫檢查點抑制劑(如 PD-1 和 PD-L1 等檢查點基因)的上調。

  • We also observed evidence of sustained chemokine elevation in the tumor microenvironment with stable chemokine levels in the blood, suggesting preferential 801 activation in the tumor. Furthermore, CX-801 is activating cell populations of both the innate and adaptive immune systems as anticipated and consistent with interferon alpha's broad mechanism of action. This initial progress with CX-801 is exactly what we aim for in assessing the initial monotherapy performance, and it lays a strong foundation for the potential of the combination with KEYTRUDA, which we initiated in May of this year.

    我們還觀察到腫瘤微環境中趨化因子持續升高,血液中趨化因子水平穩定,這表明腫瘤中 801 優先被活化。此外,CX-801 能夠活化先天性和適應性免疫系統的細胞群,這與幹擾素α的廣泛作用機制相符,也符合預期。CX-801 的初步進展正是我們在評估其初始單藥治療效果時所追求的目標,並為我們今年 5 月啟動的與 KEYTRUDA 聯合用藥的潛力奠定了堅實的基礎。

  • We currently expect initial data for the CX-801-KEYTRUDA combination by the end of 2026, and we look forward to sharing those results. Before handing over to Chris for financials, I'd like to also briefly highlight a second poster presentation we have at SITC this weekend, introducing a new program at CytomX, CX-908, a masked T-cell Engager targeting CDH3, also known as P-cadherin.

    我們目前預計到 2026 年底將獲得 CX-801-KEYTRUDA 組合的初步數據,我們期待與大家分享這些結果。在將財務部分交給 Chris 之前,我還想簡要介紹一下我們本週末在 SITC 上的第二個海報展示,介紹 CytomX 的一個新項目 CX-908,這是一種針對 CDH3(也稱為 P-鈣粘蛋白)的掩蔽 T 細胞銜接器。

  • In addition to our work on masked ADCs and cytokines, we continue to be active in the T-cell Engager space, and this preclinical data highlights the power of masking to substantially widen therapeutic window for this modality. We also continue to be active in T-cell Engagers and bispecifics in our collaborations, including with Astellas and with Regeneron.

    除了我們對掩蔽型 ADC 和細胞因子的研究之外,我們還在 T 細胞銜接器領域保持活躍,而這些臨床前數據突顯了掩蔽技術在大幅拓寬該療法的治療窗口方面的強大作用。我們也將繼續積極參與 T 細胞銜接器和雙特異性抗體的合作,包括與安斯泰來和再生元的合作。

  • With that, let me hand over to Chris.

    接下來,我將把麥克風交給克里斯。

  • Chris Ogden - Chief Financial Officer

    Chris Ogden - Chief Financial Officer

  • Thank you, Sean. Reiterating Sean's earlier sentiment, our third quarter was characterized by continued momentum with our clinical development programs, and we continue to drive towards our key milestones in a capital-efficient manner. Having completed a $100 million financing earlier this year with a strong group of investors, we are positioned to rapidly advance 2051 towards later phase development and build value in CytomX over the near and long term.

    謝謝你,肖恩。正如肖恩之前所說,我們第三季的特點是臨床開發項目持續取得進展,我們將繼續以高效的資本利用方式朝著關鍵里程碑邁進。今年早些時候,我們與一群強大的投資者完成了 1 億美元的融資,這使我們能夠迅速推進 2051 進入後期開發階段,並在近期和長期內為 CytomX 創造價值。

  • As Sean mentioned earlier, we are on track to provide a CX-2051 data update in Q1 of next year, and investing behind a potential first approval will continue to be our top capital allocation priority. We also will begin focused investments to drive additional value in CX-2051, including initiating a combination study with bevacizumab in the first quarter of next year. And we are also in the process of evaluating additional EpCAM-expressing indications for CX-2051 development.

    正如 Sean 之前提到的,我們預計在明年第一季提供 CX-2051 數據更新,而投資於可能獲得首次批准的項目仍將是我們的首要資本配置重點。我們也將開始重點投資,以推動 CX-2051 的更多價值,包括在明年第一季啟動與貝伐單抗的聯合研究。我們目前也正在評估 CX-2051 開發的其他 EpCAM 表達適應症。

  • With that, I'll now walk through our third quarter financial results. As of September 30, 2025, we ended the quarter with $143.6 million in cash, cash equivalents and investments versus $158.1 million in cash at the end of the second quarter of 2025. We continue to project that our cash balance, will be able to fund CytomX operations to at least the second quarter of 2027. As a reminder, our cash guidance does not account for any additional milestones from existing collaborations or any new business development, and we continue to make progress with our partners and expect to remain active in business development to extend the reach of our technology.

    接下來,我將詳細介紹我們第三季的財務表現。截至 2025 年 9 月 30 日,我們本季末的現金、現金等價物和投資為 1.436 億美元,而 2025 年第二季末的現金為 1.581 億美元。我們繼續預計,我們的現金餘額將足以支持 CytomX 的營運至少到 2027 年第二季。再次提醒,我們的現金流量預期並未計入現有合作或任何新業務發展帶來的額外里程碑,我們將繼續與合作夥伴取得進展,並期待繼續積極開展業務拓展,以擴大我們技術的應用範圍。

  • Looking at revenue and operating expenses for the quarter. Total revenue was $6 million compared to $33.4 million in the third quarter of 2024. The decreased revenue was primarily attributed to the completion of our performance obligations in our Bristol Myers Squibb collaboration. Operating expenses for the third quarter were $21.7 million compared to $29.3 million in the third quarter of 2024. R&D expenses were $15.3 million during the third quarter, representing a decrease of $6.1 million versus the third quarter of 2024, primarily due to a reduction in CX-904 expenses as well as reduced research expenses.

    查看本季營收和營運支出。總收入為 600 萬美元,而 2024 年第三季為 3,340 萬美元。收入下降的主要原因是我們在與百時美施貴寶的合作中履行了履約義務。第三季的營運費用為 2,170 萬美元,而 2024 年第三季的營運費用為 2,930 萬美元。第三季研發費用為 1,530 萬美元,比 2024 年第三季減少了 610 萬美元,主要原因是 CX-904 費用減少以及研發費用減少。

  • G&A expenses decreased by $1.5 million during the 3 months ending September 30, 2025, to $6.4 million, driven by lower personnel costs as well as patent and legal expenses. As we look ahead to 2026, we will continue to employ a disciplined approach to capital allocation, focused on delivering on our key program milestones for CX-2051 and CX-801 and advancing the pipeline towards later-stage development.

    截至 2025 年 9 月 30 日的三個月內,一般及行政費用減少了 150 萬美元,至 640 萬美元,主要原因是人員成本以及專利和法律費用的降低。展望 2026 年,我們將繼續採取嚴謹的資本配置方法,專注於實現 CX-2051 和 CX-801 的關鍵專案里程碑,並推進專案進入後期開發階段。

  • With that, I'll turn the call back to Sean for closing remarks.

    接下來,我將把電話轉回給肖恩,請他作總結發言。

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Thanks, Chris, and thanks, everyone, for joining us today. 2025 certainly continues to be a highly productive year for CytomX. Our PROBODY masking platform is really coming into its own with two exciting programs in the clinic that build on everything we have learned over more than a decade about how to optimally deploy this strategy that we have pioneered. CX-2051 and CX-801 both utilize validated mechanisms. And in both cases, the clinical problems we're addressing and the potential value we can create are very clear.

    謝謝克里斯,也謝謝各位今天能來參加。 2025年對CytomX來說無疑仍將是碩果累累的一年。我們的 PROBODY 掩蔽平台正在蓬勃發展,目前已有兩個令人興奮的臨床項目,這兩個項目建立在我們十多年來在如何優化部署我們開創的這一策略方面所學到的一切之上。CX-2051 和 CX-801 都採用了經過驗證的機制。在這兩種情況下,我們正在解決的臨床問題以及我們可以創造的潛在價值都非常明確。

  • We remain focused on our objective of building CytomX around these and future innovative programs and moving them further into development and ultimately to commercialization. Regarding CX-2051, our planned Q1 2026 update will encompass broad progress with the program as we look to position the initial registrational path while initiating combination strategies to support use in earlier lines of CRC therapy. This is a major opportunity. CX-801 is also off to a promising start, and we're excited to see KEYTRUDA combination data in 2026 in melanoma.

    我們將繼續專注於圍繞這些以及未來的創新項目打造 CytomX,並推動這些項目進一步發展,最終實現商業化。關於 CX-2051,我們計劃在 2026 年第一季發布更新,屆時將涵蓋該計畫的廣泛進展,我們將著手製定初步註冊方案,同時啟動聯合治療策略,以支持其在 CRC 早期治療中的應用。這是一個絕佳的機會。CX-801 也取得了令人鼓舞的開端,我們期待在 2026 年看到 KEYTRUDA 合併用藥治療黑色素瘤的數據。

  • Before I wrap up today's call, I wanted to sincerely thank all CytomX stakeholders for your support. We are here to make the biggest difference we possibly can. With that, operator, let's go ahead and open up the call for Q&A.

    在結束今天的電話會議之前,我想衷心感謝所有 CytomX 的利害關係人的支持。我們來到這裡,是為了盡我們所能做出最大的貢獻。那麼,操作員,我們現在開始問答環節。

  • Operator

    Operator

  • (Operator Instructions) Edward Tenthoff, Piper Sandler.

    (操作說明)愛德華·滕索夫,派珀·桑德勒。

  • Edward Tenthoff - Analyst

    Edward Tenthoff - Analyst

  • And really great update. I'm excited to hear all the progress with 2051 and looking forward to the 801 and the new program at SITC this weekend. My question really has to do with respect to expectations for the 2051 readout, and I appreciate that you're up to around 100 patients. What should we be expecting from an ORR? Is there a chance for that to deepen?

    非常棒的更新。我很興奮地聽到 2051 的所有進展,並期待本週末在 SITC 舉行的 801 和新項目。我的問題其實與 2051 年的預期結果有關,我知道你們現在已經有大約 100 名患者了。我們應該對 ORR 抱持什麼樣的期望?這種情況有可能會加深嗎?

  • And I know that the PFS was immature at 5.8 months, what do you guys sort of see as a win here for PFS in the late-line pieces?

    我知道 PFS 在 5.8 個月時還不成熟,你們認為 PFS 在後期產品線的優勢是什麼?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Thanks for the questions. So just to recap our data in May, which we were super excited about. As you know, across the three relevant dose levels that we're currently expanding, the 7.2, 8.6 and 10 mg/kg doses, we saw an integrated confirmed response rate of 28%, which very substantially beats the current standard of care in the late-line setting, where, as you know, response rates are in the single digits.

    是的。謝謝大家的提問。所以,讓我們回顧一下我們五月的數據,我們對此感到非常興奮。如您所知,在我們目前正在擴大的三個相關劑量等級(7.2、8.6 和 10 mg/kg 劑量)中,我們看到綜合確認反應率為 28%,這大大超過了目前後期治療的標準治療,如您所知,目前的回應率只有個位數。

  • So that gives us a lot of room to maneuver. Similarly with progression-free survival, the 5.8-month preliminary estimate based on that early data set compares to two to three months in the late-line setting for current standard of care. So our feeling is a lot of room to maneuver on the data set as it continues to mature from this larger expansion phase, and we're excited to have the update in Q1.

    這給了我們很大的迴旋餘地。同樣,在無惡化存活期方面,根據早期數據集得出的 5.8 個月的初步估計值,與目前標準治療的後期治療中的兩到三個月相比,也相當可觀。因此,我們認為隨著資料集從這個更大的擴展階段中不斷成熟,我們還有很多操作空間,我們很高興能在第一季進行更新。

  • Edward Tenthoff - Analyst

    Edward Tenthoff - Analyst

  • Yes. And I totally agree with all that. And a quick follow-up question. Will you break out dose -- or will you break out efficacy by dose? And do you think you'll have enough data at that point to really select the dose or doses in Phase 2 and Phase 3?

    是的。我完全同意以上所有觀點。還有一個後續問題。你會依劑量細分,還是會依劑量細分療效?你認為到那時你是否有足夠的數據來真正選擇第二期和第三期臨床試驗的劑量?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. We absolutely would expect to be breaking the data out by dose in this next update. I think that's going to be very important from an efficacy and safety standpoint as we continue to work towards dose selection for the next studies. Absolutely.

    是的。我們絕對會在下次更新中按劑量細分數據。我認為從療效和安全性角度來看,這一點非常重要,因為我們將繼續努力為下一階段的研究選擇合適的劑量。絕對地。

  • Operator

    Operator

  • Roger Song, Jefferies.

    Roger Song,傑富瑞集團。

  • Nabeel Nissar - Analyst

    Nabeel Nissar - Analyst

  • This is Nabeel on for Roger. Maybe two from us. Excited to hear about the enrollment picking up. What do you attribute that to? And is there any more feedback you have maybe from your trial partners in terms of what you're hearing from them and anything regarding the prophylaxis and how that's going?

    這裡是納比爾替羅傑報道。也許我們能拿出兩個。很高興聽到招生人數正在增加。你認為這是什麼原因造成的?您是否還有其他來自試驗夥伴的回饋,例如您從他們那裡聽到的關於預防措施及其進展的任何資訊?

  • And then another follow-up would be just regarding the ESMO data that we saw from some other competitors that did not differentiate from standard of care, if you had any thoughts on that as well?

    然後,還有一個後續問題,就是關於我們從其他一些競爭對手那裡看到的ESMO數據,這些數據並沒有與標準治療方案區分開來,您對此有什麼看法嗎?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Great. Thanks for the questions. In terms of enrollment, I'd take you back to the comments we made during our August updates where we were able to rapidly increase enrollment during Q2 and Q3 after the initial May disclosure to 73 patients. And that really was a reflection of the high interest from our investigators and patients to come on to the study.

    是的。偉大的。謝謝大家的提問。就招募情況而言,我想回顧一下我們在 8 月的更新報告中提到的情況,當時我們在 5 月首次向 73 名患者披露資訊後,在第二季和第三季迅速增加了招募人數。這確實反映了我們的研究人員和患者對參與這項研究的濃厚興趣。

  • And that's been continued in Q4. We continue to see a lot of demand for 2051, and we felt as we moved through this quarter that it will be helpful to continue to enroll patients and continue to gain additional experience with this drug as we work towards dose selection for our next stages of development in 2026.

    第四季也延續了這一趨勢。我們持續看到市場對 2051 的需求很大,並且我們在本季度中認為,繼續招募患者並繼續積累該藥物的更多經驗,將有助於我們在 2026 年下一階段的開發過程中選擇合適的劑量。

  • Regarding prophylaxis, that continues to be an important area of investigation. We are highly focused on really the one adverse event that we need to actively manage with the drug, which, as you know, is the diarrhea. We have implemented prophylactic measures at the early stages of the expansion phase, and we would anticipate that we will continue to learn about the AE management protocols over time. And we feel that we'll have a much better understanding of many aspects of this adverse event as we move into 2026. And I can assure you that we're very much on it.

    關於預防方面,這仍然是一個重要的研究領域。我們高度關注的是需要用這種藥物積極控制的唯一不良反應,正如您所知,那就是腹瀉。我們在擴張階段的早期就實施了預防措施,我們預計隨著時間的推移,我們將繼續了解不良事件管理方案。我們相信,隨著我們邁入 2026 年,我們將對這一不利事件的許多方面有更深入的了解。我可以向你保證,我們正在全力以赴。

  • In terms of ESMO, it was a busy conference, wasn't it? And there was quite a lot of news in CRC after such a long time of very little innovation in this space. It's really exciting to see multiple mechanisms, pathways, targets strategies being used to try to make inroads into this very difficult-to-treat cancer. We didn't really see anything that gave us any concern. We continue to believe strongly that 2051 is a highly differentiated molecule and approach.

    就ESMO而言,那真是一場繁忙的會議,不是嗎?在CRC領域經歷瞭如此長時間的創新乏力之後,該領域出現了不少新消息。看到多種機制、途徑、標靶策略被用來嘗試攻克這種極難治療的癌症,真是令人興奮。我們並沒有發現任何令人擔憂的事情。我們仍然堅信 2051 是一種高度差異化的分子和方法。

  • Of course, as an antibody drug conjugate is bringing the concept of the ADC into CRC, which we think is going to be really, really important. So we are as excited about 2051 as we have ever been.

    當然,抗體藥物偶聯物將 ADC 的概念引入了結直腸癌領域,我們認為這將非常非常重要。所以我們對2051年的期待一如既往。

  • Operator

    Operator

  • Olivia Brayar, Cantor Fitzgerald.

    奧利維亞·布雷亞爾,坎托·菲茨杰拉德。

  • Olivia Brayer - Research Analyst

    Olivia Brayer - Research Analyst

  • Congrats on all the great progress here. What is the strategy for the combination approach with bev? Are you looking at enrolling third-line patients? Or is it really more about exploring second line? And would you wait until the next CX-2051 monotherapy update to actually inform a dose escalation strategy for the combo? And then I've got one follow-up.

    祝賀你們取得的巨大進展。與飲料結合的策略是什麼?你們是否考慮招募三線治療患者?或者,它實際上更多的是在探索第二條線路?您是否會等到下一次 CX-2051 單藥治療更新後再製定合併用藥的劑量遞增策略?然後我還有一個後續問題。

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Thanks, Olivia. Thanks for the question. So the strategy initially, of course, we will be beginning by looking at a few doses of 2051 to explore the combination with bev as we -- because we're beginning this study in Q1. We think it's important to get this study going.

    是的。謝謝你,奧莉維亞。謝謝你的提問。所以最初的策略當然是,我們將首先研究幾劑 2051,以探索其與貝伐珠單抗的組合,因為我們將在第一季開始這項研究。我們認為啟動這項研究非常重要。

  • It's a crucial part of the development plan as we broaden out the 2051 strategy to bring the drug into earlier lines of therapy.

    這是發展計畫的關鍵部分,因為我們要擴大 2051 年策略,將藥物納入更早的治療方案中。

  • So -- but starting in Q1, it will be concurrent with continued evaluation of dose selection for monotherapy. So I anticipate that we'll be looking at more than one dose of 2051 with bev. Obviously, the goal ultimately is to get into the second-line setting. Specifically, which patients we enroll into the very earliest phases of the combination, that remains to be determined. In terms of the data update on the combo, too early to tell.

    所以——但從第一季開始,它將與單藥治療劑量選擇的持續評估同時進行。所以我預計我們將看到不只一劑 2051 與 bev 一起服用。顯然,最終目標是進入二線陣容。具體來說,我們將哪些患者納入聯合治療的早期階段,這仍有待確定。至於該組合的數據更新情況,現在下結論還為時過早。

  • We want to get the study going, and we'll see how it's -- timing-wise, we'll see how it aligns with future updates on the monotherapy.

    我們希望啟動這項研究,至於時間安排,我們會看看它與單藥療法的未來進展是否吻合。

  • Olivia Brayer - Research Analyst

    Olivia Brayer - Research Analyst

  • Okay. That's helpful. And then what can you tell us at this point just around the percentage of patients who you actually expect to receive loperamide in the dose expansion phase for the monotherapy? Are there any parameters that you guys have put in place in terms of which patients can or can't receive it? Or is it really truly at the investigator's discretion?

    好的。那很有幫助。那麼,在單藥治療的劑量擴展階段,您預期實際接受洛哌丁胺治療的患者比例是多少?你們有沒有訂定一些標準來規定哪些病人可以接受這種治療,哪些病人不能接受?或者,這真的完全由調查人員自行決定嗎?

  • And then just to kind of sneak in a point of clarification on that. Can that loperamide regimen, can it actually be used both proactively for prevention, but also reactively at first onset of diarrhea?

    然後,我想順便澄清一點。洛哌丁胺治療方案是否可既用於主動預防,又可用於腹瀉初發時的被動治療?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • I'll take the second question first. And the answer there is yes. I mean loperamide is used -- it's a common drug to be used to manage diarrhea for any medicine that has that adverse event. So that's a very normal thing to do. But it's also been shown to be effective, as you know, for example, in the PRIME study with TRODELVY, where upfront treatment of patients with loperamide was effective in reducing the rates of Grade 3 diarrhea in patients treated with that particular TOPO I ADC.

    我先回答第二個問題。答案是肯定的。我的意思是,洛哌丁胺是一種常用的藥物,用於治療任何會引起腹瀉的藥物的副作用。所以這是件很正常的事。但如您所知,它也已被證明是有效的,例如在 TRODELVY 的 PRIME 研究中,對患者進行洛哌丁胺的初始治療可有效降低接受該特定 TOPO I ADC 治療的患者中 3 級腹瀉的發生率。

  • In terms of our study, as we've said previously multiple times, we instituted loperamide prophylaxis in the protocol concurrent with initiating the expansions in April. We did leave the investigators some level of discretion there. Loperamide, as we've commented before, does not come without its own side effects. And so that has to be used thoughtfully and deployed thoughtfully. And so we felt it was important to give investigators the flexibility because, of course, they're managing their patients on the ground as it were.

    就我們的研究而言,正如我們之前多次提到的,我們在 4 月啟動擴展的同時,也在方案中引入了洛哌丁胺預防。我們確實給調查人員留有一定的自由裁量權。正如我們之前提到的,洛哌丁胺並非沒有副作用。因此,必須謹慎使用和部署。因此,我們認為給予調查人員一定的彈性非常重要,因為他們當然是在現場管理他們的病人。

  • Over time, and again, just to really emphasize, we are laser-focused on this question of learning more about the onset, the timing, the overall etiology of diarrhea in these patients and learning how to get ahead of it with loperamide. And over time, as we learn more, I would anticipate that our AE management plan will continue to evolve and continue to be refined as we move into 2026 and towards discussions with FDA relating to dose selection and, of course, navigating Project Optimus.

    隨著時間的推移,我們再次強調,我們正專注於研究這些患者腹瀉的發病、時間、整體病因,並學習如何使用洛哌丁胺來預防腹瀉。隨著時間推移,我們了解得越多,我預計我們的不良事件管理計劃將不斷發展和完善,直至 2026 年,並與 FDA 就劑量選擇進行討論,當然還有推進 Optimus 項目。

  • Operator

    Operator

  • Matthew Biegler, Oppenheimer.

    馬修·比格勒,奧本海默。

  • Matthew Biegler - Analyst

    Matthew Biegler - Analyst

  • Thank you so much for the update here. I just wanted to ask a follow-up one on your current thinking of the regulatory strategy, particularly as a monotherapy. Do you think you can go head-to-head against bev-Lonsurf in the third line? Or are you thinking monotherapy would more likely be a fourth-line trial against, I guess, physicians' choice?

    非常感謝您提供的最新消息。我只是想就您目前對監管策略的看法,特別是作為單一療法的看法,再問一個後續問題。你認為你能在第三組與 bev-Lonsurf 正面競爭嗎?或者您認為單藥療法更有可能是作為第四線試驗來對抗,我猜是作為醫生的選擇?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Thanks, Matt. Look, I think everything is still on the table. So we're generating now an even more substantial data set with the continued enrollment into the Phase I. And I think we feel, as we commented previously, pretty confident that the very first look at the profile of 2051 showed us that this drug has the potential to comprehensively beat standard of care in the fourth line. So that seems clear from the very early data set.

    是的。謝謝你,馬特。你看,我覺得一切都有可能。因此,隨著 I 期臨床試驗的持續招募,我們正在產生更龐大的數據集。而且我認為,正如我們之前評論的那樣,我們相當有信心,對 2051 的初步分析表明,這種藥物有潛力在四線治療中全面超越標準療法。從最早的數據集來看,這一點似乎很明顯。

  • In the third line, of course, we know that bev-Lonsurf has a PFS of 5.5-ish months. And we need to see our data mature to have a better handle and understanding of how competitive monotherapy 2051 can be in the third-line setting. So that remains to be determined, but it's very much still on the table as we collect more data, we follow our patients for longer. And by the time we get to Q1 of 2026, just to further build on one of the earlier questions asked, we do anticipate that we'll have estimates of PFS at all 3 of the expansion doses. So that will be, I think, very helpful and informative in helping us lay out what our thinking is at that time about the go-forward potential registrational path.

    當然,在第三行中,我們知道 bev-Lonsurf 的 PFS 約為 5.5 個月。我們需要觀察數據是否成熟,才能更好地掌握並了解 2051 單藥療法在三線治療中的競爭力。所以這還有待確定,但隨著我們收集更多數據,對患者進行更長的隨訪,這仍然是一個值得考慮的方案。到 2026 年第一季度,為了進一步解答先前提出的一個問題,我們預計我們將獲得所有 3 個擴展劑量的 PFS 估計值。所以,我認為這將非常有幫助,也很有啟發性,可以幫助我們闡明當時我們對未來潛在註冊途徑的想法。

  • Operator

    Operator

  • Anupam Rama, JPMorgan.

    Anupam Rama,摩根大通。

  • Unidentified Participant

    Unidentified Participant

  • This is Joyce on for Anupam. I understand there's a host of other tumor types outside of colorectal where 2051 could have potentially meaningful benefit. What are your thoughts on which tumor types you're most excited for? And then what should we expect in terms of timing or cadence next year of new proof-of-concept studies in these other tumors? And just how are you balancing that with your development plans in CRC?

    這裡是喬伊斯,替阿努帕姆報道。我知道除了大腸癌之外,2051 還可能對許多其他類型的腫瘤產生潛在的顯著益處。你最期待看到哪些類型的腫瘤?那麼,明年針對其他腫瘤進行的新概念驗證研究,在時間安排或節奏方面,我們應該抱持怎樣的預期呢?那麼,您是如何平衡這一點與您在CRC的發展計畫之間的呢?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Thanks. Great question. And in a similar way to how we like to refer to 2051 as potentially being a pan-CRC drug. It really has pan-tumor potential given the widespread expression of EpCAM on so many solid tumor types.

    是的。謝謝。問得好。就像我們喜歡把 2051 稱為一種可能治療泛結直腸癌的藥物一樣。鑑於 EpCAM 在多種實體瘤類型中廣泛表達,它確實具有泛腫瘤治療潛力。

  • We're eager to get going in additional cancers, and there are many of them, gastric, endometrial, uterine, pancreatic, lung, it's a long list. And so we're enthusiastic to get going. At the same time, we've got so much work to do in colorectal that we need to be thoughtful of timing. But I do anticipate that we'll have updates on the initiation of additional cohorts and additional tumor types in 2026. We are working towards that.

    我們渴望著手研究其他癌症,而癌症種類繁多,例如胃癌、子宮內膜癌、子宮癌、胰臟癌、肺癌等等,不勝枚舉。因此,我們迫不及待地想要開始。同時,我們在結直腸領域還有很多工作要做,所以我們需要認真考慮時機。但我預計,我們將在 2026 年獲得有關啟動更多隊列和更多腫瘤類型的最新消息。我們正在朝著這個方向努力。

  • Operator

    Operator

  • Etzer Darout, Barclays.

    埃策爾·達魯特,巴克萊銀行。

  • Etzer Darout - Equity Analyst

    Etzer Darout - Equity Analyst

  • Just a couple of ones for me. On the over enrollment that you're seeing, just wondered if any of the additional enrollment is skewed to any of the three doses that you're exploring? And then of sort of this 100 patients or so, are we going to get a breakout maybe of maybe less pretreated patients versus the four median prior therapy patients we got in the initial update?

    我只有幾個。關於您觀察到的超額報名情況,我想知道新增的報名人數是否有偏向您正在研究的三種劑量中的任何一種?那麼,在這大約 100 名患者中,我們是否會發現一些接受過預治療的患者數量少於我們在最初更新中發現的 4 名接受過預治療的中位數患者?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Thanks, Etzer. So in terms of enrollment, I mean, I can say that we're enrolling patients at similar dose levels or within the same dose ranges that we've been expanding. Not quite ready to comment on specifically which doses that we're adding additional patients, but we're really thrilled that with the speed and rate of continued enrollment during Q4, it's going to give us a lot of additional information, important information as we move towards dose selection in the early part of next year.

    是的。謝謝,埃策爾。所以就招募人數而言,我的意思是,我們可以說,我們正在以相似的劑量水平或在相同的劑量範圍內招募患者,而我們一直在擴大劑量範圍。目前還不方便具體評論我們將增加哪些劑量組的患者,但我們非常高興,隨著第四季度患者招募速度的加快,這將為我們提供很多額外的信息,這些信息對於我們在明年年初進行劑量選擇至關重要。

  • In terms of breaking out less or -- it's a really interesting question, less heavily pretreated or more heavily pretreated. We may look at that, but I can say that the patient population that we're continuing to enroll is pretty consistent with what we saw in the first 20 to 25 patients that we shared in May. So still pretty late-line CRC.

    至於爆痘程度,或者──這是一個非常有趣的問題,是預處理程度較低還是較高。我們可能會考慮這一點,但我可以肯定地說,我們正在繼續招募的患者群體與我們在 5 月分享的前 20 到 25 名患者的情況非常一致。所以仍然是比較晚期的CRC。

  • So if you're wondering whether we'd have, for example, some initial suggestions of maybe some second-line patients that may have squeezed into the study or a large number of third line. I don't anticipate that to be the case. I think we're really still going to be, at least for now, in the pretty late-line setting. That said, of course, we're -- we always want to try to analyze and squeeze as much information out of every patient and data set as we can.

    所以,如果您想知道我們是否會有一些初步建議,例如,一些可能擠進研究的二線患者,或大量的三線患者。我不認為情況會如此。我認為至少目前來看,我們仍然會處於相當靠後的局面。當然,我們總是希望盡可能地分析和挖掘每個患者和資料集中盡可能多的信息。

  • Operator

    Operator

  • (Operator Instructions) Mitchell Kapoor, H.C. Wainwright.

    (操作說明)米切爾·卡普爾,H.C. 溫賴特。

  • Mitchell Kapoor - Equity Analyst

    Mitchell Kapoor - Equity Analyst

  • Congrats on the progress to date. Just wanted to ask if you could elaborate on your interactions with the FDA so far and what they have indicated their feelings are about what would be registrational or positive in the fourth-line setting. Would that -- have they said anything like 20%, 25% ORR and 6 months PFS would be impressive to them? Anything that you could say about what their alignment has been like with you all to date? And what was the last time you spoke with them about the registrational plans?

    恭喜目前的進展。我想問一下,您能否詳細說明您目前與 FDA 的互動情況,以及他們對四線治療中哪些藥物可以註冊或獲得批准持何種態度。他們是否說過,20%、25% 的 ORR 和 6 個月的 PFS 對他們來說就夠令人印象深刻了?您能否談談他們迄今為止與你們的合作情況?你上次和他們談登記計畫是什麼時候?

  • Obviously, there's been a lot of changes with the FDA, but I just want to know when the last communication was and when you plan to meet with them again?

    顯然,FDA方面發生了很多變化,但我只想知道上次溝通是什麼時候,以及你們計劃何時再次與他們會面?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. Thanks, Mitch. So obviously, regulatory strategy is something we're going to be super focused on as we move into 2026. We anticipate those discussions to happen next year.

    是的。謝謝你,米奇。顯然,在邁向 2026 年之際,監管策略將是我們重點關注的領域。我們預計這些討論將在明年進行。

  • Mitchell Kapoor - Equity Analyst

    Mitchell Kapoor - Equity Analyst

  • Okay. Great. And then just secondly, if you could talk about your updated thoughts on BioAtla's EpCAM bispecific. What are the puts and takes there in terms of read-through, but also differentiation where we should think about your strategy in a different way?

    好的。偉大的。其次,能否請您談談您對 BioAtla 的 EpCAM 雙特異性抗體的最新看法?從理解的角度來看,有哪些需要注意的地方?此外,在差異化方面,我們該如何以不同的方式思考你的策略?

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Yes. We think that it's an interesting strategy as the EpCAM CD3 conditional activation approach. We obviously know that -- all know there's a lot of EpCAM in colorectal cancer and leveraging that particular effective strategy, I think, could make some sense. We feel like -- at CytomX, we really feel like the ADC strategy is the right one.

    是的。我們認為 EpCAM CD3 條件活化方法是一種有趣的策略。我們當然都知道——大家都知道結直腸癌中有很多 EpCAM,我認為利用這種特殊的有效策略可能是有意義的。在 CytomX,我們真心認為 ADC 策略是正確的。

  • Operator

    Operator

  • I'm not showing any further questions in the queue. I would now like to turn it back over to Dr. Sean McCarthy, Chairman and CEO, for closing remarks.

    隊列中不再顯示任何其他問題。現在我謹將發言權交還給董事長兼執行長肖恩·麥卡錫博士,請他作總結發言。

  • Sean McCarthy - Chairman of the Board, Chief Executive Officer

    Sean McCarthy - Chairman of the Board, Chief Executive Officer

  • Thanks very much, and thanks, everyone, for tuning in today. It's been great to give an update. We're super excited about our progress in 2025 and the direction that CytomX is headed with our clinical programs and our platform overall and our collaboration. So thanks for your time and look forward to following up.

    非常感謝,也感謝大家今天的收看。很高興能向大家報告最新情況。我們對 2025 年的進展以及 CytomX 在臨床計畫、整體平台和合作方面的發展方向感到非常興奮。感謝您抽出時間,期待後續跟進。

  • Operator

    Operator

  • Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

    謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。