CytomX (CTMX) 2026 年第三季財報電話會議:Varseta-M 研究目標定於 2027 年上半年
截至2026年第三季末,CytomX持有3.48億美元現金與投資,現金部位預期可支撐營運至2028年下半年。第三季營收降至170萬美元,營業費用增至2,520萬美元。該公司目標於2027年上半年啟動Varseta-M針對轉移性大腸直腸癌的首個潛在註冊性臨床試驗,並計劃於2027年1月公布第一期臨床試驗的綜合最新進展及首個整體存活期數據。
重點摘要
- CytomX 截至 2026 年第三季末持有 3.48 億美元 的現金、約當現金與投資,高於 3.3 億美元(截至 2026 年 6 月 30 日)。該季末餘額包含 3,700 萬美元來自 Regeneron 在選定另外兩個合作標的後所支付的款項。
- 第三季營收下滑至 170 萬美元,相較於前一年同期為 600 萬美元,主因是與安斯泰來(Astellas)的合作於 2026 年第二季結束。
- 營業費用增加至 2,520 萬美元,高於 2,170 萬美元,反映出人事相關成本與顧問支出增加。
- 管理階層預計目前的現金部位將可支持營運至 2028 年下半年,包括推動 Varseta-M 進入其首個潛在註冊性臨床試驗的計畫。
- CytomX 預期將於 2027 年 1 月 提供 Varseta-M 第一期臨床試驗的綜合最新進展,包括首個整體存活期數據、劑量選擇資訊及其潛在的註冊策略。
- 該公司目標於 2027 年上半年 啟動 Varseta-M 針對轉移性大腸直腸癌的首個潛在註冊性臨床試驗。管理階層預期在一項隨機對照試驗中,整體存活期將作為主要試驗終點。
關鍵財務數據
| 指標 | 2026 年第三季 | 2025 年第三季 / 前期 | 變動與說明 |
|---|---|---|---|
| 營收 | 170 萬美元 | 600 萬美元 | 減少 430 萬美元,主因是與安斯泰來的合作於 2026 年第二季結束 |
| 營業費用 | 2,520 萬美元 | 2,170 萬美元 | 增加 350 萬美元 |
| 研發費用 | 1,650 萬美元 | 年增 120 萬美元 | 人事成本增加,但部分被 Varseta-M 生產支出的認列時程所抵銷 |
| 一般及行政費用 | 870 萬美元 | 640 萬美元 | 增加 230 萬美元,主因人事與顧問費用增加 |
| 現金、約當現金及投資 | 3.48 億美元 | 截至 2026 年 6 月 30 日為 3.3 億美元 | 包含自 Regeneron 收到的 3,700 萬美元 |
業務與營運表現
Varseta-M 單一療法
Varseta-M 是一款基於 CytomX 的 ProBody 平台開發、針對 EpCAM 標靶的 Topo1 抗體藥物複合體(ADC)。該公司初步針對轉移性大腸直腸癌開發該藥物,並稱其為目前唯一處於臨床開發階段的 EpCAM 標靶 ADC。
該第一期單一療法試驗已在劑量遞增、擴展及優化佇列中收錄超過 100 名患者。多數受試者先前已接受過至少三種針對轉移性疾病的治療。
劑量優化階段正在評估 每三週給予 8.6 mg/kg 及 10 mg/kg,並採用校正理想體重計算給藥劑量,配合前期預防性給藥來控制胃腸道不良事件。CytomX 計劃在 2027 年 1 月的更新報告中公布綜合療效與安全性結果、首個整體存活期分析,以及支持劑量選擇的數據。
大腸直腸癌合併療法開發
Varseta-M 併用 bevacizumab 的第一期試驗持續收錄後線大腸直腸癌患者。初步臨床數據預計於 2027 年上半年 公布,具體視試驗進度而定。
CytomX 亦維持進度,預計於 2026 年底前 啟動一項新的第一/二期試驗,以評估 Varseta-M 併用 bevacizumab、5-氟尿嘧啶(5-fluorouracil)及亞葉酸(leucovorin)。第一期預計將從晚期患者開始進行劑量探索;若劑量探索成功,第二期將接續納入二線大腸直腸癌患者。該策略係以 Varseta-M 取代 irinotecan。
拓展至其他實體腫瘤
該公司已在未經篩選的胃癌與胃食道交界處癌,以及經 EpCAM 篩選的胰腺導管腺癌與膽道癌中啟動第一期佇列。CytomX 最初計劃 每個腫瘤類型招募約 20 名患者,以評估抗腫瘤活性與安全性,隨後再決定後期開發方案。
CX-801
候選遮蔽型干擾素 alpha-2b 藥物 CX-801 作為單一療法及併用 Keytruda 治療檢查點抑制劑抗藥性黑色素瘤的第一期試驗持續收案中。CytomX 預期將於 2027 年上半年 公布黑色素瘤的初步臨床數據。
管理階層營運指引
管理階層預計現金儲備可支撐營運至 2028 年下半年。該公司表示,這段資金跑道能支持其主要研發重點:推進 Varseta-M 邁向潛在註冊性試驗、評估用於更前線大腸直腸癌的合併療法,以及拓展至其他表現 EpCAM 的胃腸道腫瘤。
CytomX 目標於 2027 年上半年 展開 Varseta-M 的首個潛在註冊性臨床試驗。最終的病患族群、對照藥物與劑量仍在評估中,主管機關的反饋意見亦將納入開發計畫。
風險與觀察重點
- 胃腸道毒性:第 3 級腹瀉仍是目前積極管控的主要不良事件。CytomX 先前在首批 20 名劑量優化患者中,經過兩個月匹配追蹤後觀察到發生率為 10%,而同期匹配的劑量遞增與擴展患者發生率則超過 30%。
- 劑量優化:管理階層的目標是將第 3 級腹瀉發生率控制在 20% 或以下。該公司表示,報告的中位發病時間約為五週,且毒性尚未呈現累積性。
- 合併療法耐受性:當 Varseta-M 與 5-氟尿嘧啶(5-fluorouracil)合併使用時,CytomX 將密切監控胃腸道毒性。管理階層指出,維持劑量強度對無惡化存活期與整體存活期可能相當關鍵。
- 註冊試驗設計:該公司仍在評估三線及後線患者族群、合適的對照藥物以及最終劑量。管理階層提到,在曾接受 bevacizumab 治療的患者中,Lonsurf 併用 bevacizumab 報告約九個月的整體存活期,是目前納入考量的重要參考指標。
- 競品研發競爭:管理階層指出 Trop-2、M7088 與 CDH17 等 ADC 計畫是大腸直腸癌領域的競爭療法,這促使該公司更加專注於加速 Varseta-M 的開發。
分析師問答重點
- 1 月更新報告的時程:管理階層表示,從 2026 年底延後,是為了爭取更多追蹤安全性與療效的時間、獲得更成熟的無惡化存活期與整體存活期數據,並與監管主管機關進行溝通。
- 潛在關鍵試驗:CytomX 預期最初的註冊性試驗將是一項隨機對照試驗,並以整體存活期作為主要終點。有關治療線別、對照組與選定劑量的詳細資訊,預計將於 1 月的更新報告中公布。
- 更前線治療策略:bevacizumab 與化療合併研究的第一期部分可能會先納入晚期患者。在劑量探索成功後,第二期部分則擬鎖定二線大腸直腸癌患者。
- 安全性差異化優勢:管理階層強調,相較於其他 Topo1 ADC,Varseta-M 所觀察到的血液學毒性發生率較低,但同時也承認胃腸道毒性仍是需要監測與緩解的主要面向。
- 校正理想體重給藥:劑量優化佇列中的每位患者均使用校正理想體重演算法來計算劑量。該公司計劃在確定註冊試驗給藥方案前,先分析隨時間推移的絕對劑量與劑量強度。
完整法說會逐字稿
完整財報電話會議逐字稿
管理層陳述
Operator
CytomX's Chief Financial Officer. Please go ahead.
Chris Ogden
Thank you. Good afternoon and thank you for joining us. Before we begin, I would like to remind everyone that during this call, we'll be making forward-looking statements. Because forward-looking statements relate to the future, they're 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. Except as required by law, 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 filed our quarterly report on Form 10-Q for 3Q '26 and issued a press release with a summary of our third quarter 2026 financial results and business highlights.
We encourage everyone to read today's filing and press release. 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. Sean McCarthy, CytomX's 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'll then conclude with a Q&A session. With that, I'll turn the call over to Sean.
Sean McCarthy
Thanks, Chris, and good afternoon, everyone. We're very pleased to be here today to provide an update on our third quarter developments and what continues to be a highly productive year for CytomX as we advance our lead program, Varseta-M, towards its first potential registrational study in the first half of 2027. Varseta-M is an EpCAM-targeting Topo1 antibody-drug conjugate with strong potential in colorectal cancer and potentially other solid tumors. Importantly, to our knowledge, Varseta-M is first-in-class as the only EpCAM-directed ADC in clinical development. Varseta-M has been intentionally designed and uniquely enabled by our ProBody platform, creating a significant opportunity for differentiation and long-term value creation. Strategically, we are initially developing Varseta-M in metastatic colorectal cancer as the lead indication. Our sense of urgency for Varseta-M is driven by the significant unmet need in colorectal cancer, which is the second leading cause of cancer death in the United States and worldwide.
Varseta-M is on the leading edge of ADC innovation in CRC and has the potential to be 1 of the first monotherapy ADCs to market for the treatment of this very challenging cancer type. In terms of commercial potential, there are an estimated 35,000 addressable patients in the United States with third-line or later CRC. Given the anti-cancer activity we have reported previously across an unselected late-stage patient population and the limited clinical benefit of existing therapies for these patients, we see considerable opportunity for Varseta-M.
Based on Varseta-M's unique profile, we are actively advancing our development program across 3 strategic areas of priority. First, we aim to move our Varseta-M monotherapy into a registrational study in the first half of next year, enabling a potential first approval and meaningful market opportunity in metastatic CRC. Second, we continue our development of Varseta-M in combinations, including with Bevacizumab and with earlier line chemotherapy regimens with the goal of replacing current standard of care. And third, we have started to evaluate Varseta-M's pan-tumor potential across multiple EpCAM-expressing cancers, initially in additional gastrointestinal indications.
The monotherapy Varseta-M Phase 1 study has enrolled more than 100 patients across dose escalation, expansion, and optimization cohorts. As previously reported, patients enrolled in the Phase 1 study have been heavily pretreated, with most patients having received 3 or more prior treatments in the metastatic setting. In March, we reported encouraging progression-free survival at doses of 8.6 and 10 mg/kg that exceeded current standard of care. We also shared our increasing understanding of the safety profile of Varseta-M, particularly how to lower and manage rates of high-grade diarrhea. This initial experience with Varseta-M in very late-line patients will provide us with a highly relevant dataset to enable monotherapy dose selection and inform the potential first registrational study design.
Most recently, we have been highly focused on dose optimization, evaluating 2 doses, 8.6 and 10 mg/kg given every 3 weeks with adjusted ideal body weight dosing and upfront prophylaxis to manage gastrointestinal adverse events. We anticipate providing an integrated update in January across the Phase 1 study, including our potential registrational strategy and the data that underpin our plans. It's important to note here that we expect this next update to provide the first look at overall survival for Varseta-M, which we anticipate will be the primary endpoint in our initial registrational study. We look forward to providing this next update in the near term.
Now moving on to the Varseta-M combination development program. Our ongoing Phase 1 study evaluating Varseta-M in combination with Bevacizumab continues to enroll late-line CRC patients to assess dose and safety. We view this combination as a foundational first step in evaluating Varseta-M's potential in earlier line CRC. Subject to data from the ongoing Phase 1 study, we anticipate moving to earlier line CRC patients in the future evaluation of this combination, and we anticipate reporting initial clinical data from the Bevacizumab combination in the first half of 2027.
To also enable the use of Varseta-M in earlier lines of CRC therapy, we remain on track to initiate a study evaluating Varseta-M in combination with Bevacizumab, 5-fluorouracil, and Leucovorin by the end of the year. This study will be a new Phase 1/2 trial that would enroll second-line CRC patients once Phase 1 dose finding is successfully completed. We believe these Varseta-M combination studies have the potential to inform future development options and look forward to providing initial updates starting next year.
Now moving to the development of Varseta-M outside of CRC, our strategy is to develop and ultimately commercialize Varseta-M across multiple EpCAM-expressing solid tumors. And we have recently initiated Phase 1 cohorts in gastrointestinal indications with substantial unmet need and that we view as highly complementary to CRC from a commercial perspective. We have initiated cohorts in unselected gastric and gastroesophageal junction cancer as well as EpCAM-selected pancreatic ductal adenocarcinoma and EpCAM-selected biliary tract cancer. Each of these EpCAM-expressing tumor types currently have limited treatment options in later-line settings and may present expedited development pathways for Varseta-M upon clinical proof of concept. Our initial plan is to enroll approximately 20 patients per tumor type to evaluate Varseta-M's anti-tumor activity and safety before assessing later phase development options. Having focused Varseta-M exclusively in CRC for the first 2 years of development, we're very excited to now be evaluating Varseta-M's broader clinical potential.
Now turning to CX-801, our masked interferon alpha-2b program being evaluated in checkpoint refractory melanoma. We see CX-801 as an exciting and broad opportunity to reprogram the immune responsiveness of solid tumors. And we continue to enroll the ongoing Phase 1 study evaluating CX-801 as a monotherapy and in combination with Keytruda. Enrollment in the monotherapy cohort of our Phase 1 study continues, having exceeded dose levels of the approved dose of unmasked interferon alpha-2b. Initial biomarker data for CX-801 monotherapy presented previously have reinforced our mechanism of action hypothesis for CX-801 in combination with Keytruda. We continue to enroll in the combination cohort, and we look forward to sharing initial clinical data from the Phase 1 study in melanoma in the first half of 2027.
With those updates, let me now transition the call back to Chris.
Chris Ogden
Thank you, Sean. As Sean highlighted, we are making important progress across the Varseta-M program, including potentially moving towards later-stage development. As we progress the broadening Varseta-M development program, we have continued to maintain an efficient and flexible cost structure, enabling us to pursue the opportunities Sean described earlier. To that end, with our current balance sheet, we project cash runway into the second half of 2028. Importantly, our runway funds our key value creation priorities that Sean outlined, including advancing Varseta-M into its first potential registrational study, pursuing combination development to move Varseta-M into earlier lines of CRC, and then expanding into multiple other EpCAM-expressing gastrointestinal tumors.
With that, I'll now walk through our third quarter financial results. As of September 30, 2026, we ended the quarter with $348 million in cash, cash equivalents, and investments versus $330 million in cash as of June 30, 2026. The cash balance as of September 30, 2026 includes $37 million received from Regeneron following its selection of 2 additional targets under the recently expanded collaboration.
Looking at revenue and operating expenses for the quarter, total revenue was $1.7 million, compared to $6 million in the third quarter of 2025. The decrease in revenue was primarily attributed to the conclusion of the Astellas collaboration in the second quarter of 2026. Operating expenses for the third quarter were $25.2 million compared to $21.7 million in the third quarter of 2025. Research and development expenses were $16.5 million during the third quarter, representing an increase of $1.2 million versus the third quarter of 2025, primarily due to increased personnel-related costs and partially offset by lower Varseta-M spending due to the timing of manufacturing activities. General and administrative expenses increased by $2.3 million during the 3-month period ending September 30, 2026 to $8.7 million compared to $6.4 million for the corresponding period in 2025. Increased G&A expenses were primarily driven by personnel-related expenses and higher consulting spend.
As we move towards 2027, we will continue to be disciplined in capital allocation in order to progress the most compelling Varseta-M development priorities, and realize the broader value creation potential for CytomX stakeholders. With that, operator, let's go ahead and open up the call for Q&A.
Operator
[Operator Instructions]
Our first question comes from the line of Paul Jeng with Guggenheim.
分析師問答
Paul Jeng
So I guess my first question is, can you expand a little bit about the Bev chemo combo study that's getting underway this quarter? Anything about the target enrollment number, and will this exclusively enroll second-line patients from the outset? And then, on the patients themselves, are you focusing more on patients coming off a FOLFOX-based frontline regimen, or do you otherwise plan to stratify by any key baseline characteristics? And then I have a follow-up.
Sean McCarthy
Great, thanks for the questions there, and we're really excited about the progress overall with the program and particularly moving further into the second line downstream with Varseta-M into the combination setting. And as we pointed out, the gaining of experience with Varseta-M in combination initially with Bev, which is ongoing, and soon to start with Bev plus chemotherapy, is a really important component of the program.
We do anticipate initially in the first part, the Phase 1 part of the study, that we'll enroll most likely late-stage patients as we dose range and gain initial experience of the combination strategy. And then as we open up further down the road, the Phase 2 part of the study, that would enroll second-line patients. And that's really all the detail that we're ready to give at this moment in time.
Paul Jeng
So then my second question is just would be great to get your current perspective on the broader landscape of ADCs in colorectal. Now there's a few competitors in Phase 3 as well as some recent data from emerging targets at ESMO. So how are you currently thinking about the positioning of Varseta-M given many of these are all using Topo1 payloads? Thank you.
Sean McCarthy
Yes, it's actually really exciting to see the field evolving in the way it is. I think we can say now quite clearly that antibody-drug conjugates are coming to colorectal cancer patients. It's been a long time coming, and this is just a really exciting development for the field overall, and of course, for the patients who are waiting and in desperate need for these innovative therapies. I want to really emphasize, in addition, of course, that our drug, Varseta-M, is the only EpCAM-targeting ADC. We are first-in-class on this target. We think that's a direct reflection of our proprietary masking technology. We've really been able to do something that no one else has been able to do.
We think that puts us in a strong position from a differentiation standpoint over time. And with regard to the other programs, yes, there are several to watch, and we're keeping a very close eye on them: the Trop-2 ADC, the Merck Serono program, M7088, and then more recently, I think as you're alluding to, including at ESMO, a number of CDH17 ADCs that have shown some encouraging, we think preliminary, data. We believe we've got to keep up a very competitive asset here, and it really underscores and fuels our urgency to move Varseta-M forward as rapidly as we can.
Operator
Our next question comes from the line of Etzer Darout with Barclays.
Etzer Darout
Just curious about the OS update in January for the first 73 or so patients. If you could maybe comment on when you think about third-line versus line setting versus pursuing a faster fourth-line setting. Is there a threshold relative to the roughly 9-month OS benchmark in Bev-experienced patients receiving Lonsurf plus Bev that you're looking at to decide whether you're going to go after maybe a third-line versus a fourth-line indication, knowing that the fourth line would probably get through the market faster? How are you thinking about that, and then I have a follow-up?
Sean McCarthy
Thanks, that's a great question, and you quite rightly point out the 9-month there or thereabouts OS that has been reported for Bev-Lonsurf in the post-Bev setting per the SUNLIGHT trial. That is an important number we are looking at relative to other components of standard of care in the third line, third line plus. And we continue to evaluate these options as we look towards potentially initiating this first registrational study in the first half of next year. We're continuing to look at these 2 options in terms of how we increasingly think about third line plus as the place to go.
And really the key questions for us are, what will be in this first pivotal study, what will the patient population be, what's the appropriate comparator in that patient population? Because I want to remind you that in the third line plus setting, although Bev-Lonsurf is, of course, thought of as the dominant therapy in the third line, treatment of third line patients and later is actually quite fragmented. And we see, as we really lock in on this study design, we think there's a number of ways to go to capture a significant portion of the third line plus market with a number of different designs. So more to come on that, and your question also does allow me to restate what I said in my prepared remarks, which is that we do anticipate that in this first registrational study, the OS will be our primary endpoint in a randomized study.
Etzer Darout
Great, thank you for that. And then for the January update now, is that primarily a planned conference timing and data maturation? Just wondered if you could comment on that in terms of now the data being in January of next year.
Sean McCarthy
We haven't specified the forum at this time. That will come in due course.
Operator
Our next question comes from the line of Edward Tenthoff with Piper Sandler.
Edward Tenthoff
I wanted to ask, with respect to the Avastin chemo arm study that you're going to start, in which it looks like you're replacing oxaliplatin, what safety endpoints are you going to be evaluating there to see whether or not the combination with Varseta-M is better tolerated? And maybe you can remind me how large that study would be. Thank you very much.
Sean McCarthy
Hi, Ted. Thanks for the questions. So the strategy in the Bev chemo combo will be to replace irinotecan with the ADC, so of course the Topo1 ADC really having been designed with that as 1 of the goals in mind. That's a very important part of the strategy. In terms of the safety profile, of course, this work is all about initially evaluating the combinability of Varseta-M with these other agents. And 1 of the things that we think could be very attractive about the Varseta-M safety profile that we've learned a lot about so far is the quite remarkably low rate of hematologic toxicity we see with Varseta-M relative to other Topo1 ADCs in development in CRC and elsewhere. So we think that certainly is an advantage.
I'd say the area that we'll be paying closest attention to would be the GI toxicity. We know that we have a certain rate of Grade 3 diarrhea with Varseta-M, something that we're continuing to learn a lot about and getting an increasing handle on, but that is something that we'll be watching very carefully in combination, particularly with 5-FU. But I would also say that, of course, irinotecan, since we're switching out irinotecan for Varseta-M, irinotecan itself has been known since the early days of its development to have its own rate of Grade 3 diarrhea. So we're switching Varseta-M for irinotecan, which I think could work in our favor. But we really need to do the work to evaluate the combinability.
Edward Tenthoff
Yes, makes sense. And would you be implementing the ideal body weight dosing and diarrhea mitigation in those studies, just as you have with monotherapy of Varseta-M?
Sean McCarthy
I think that's most likely, yes. Since we're still in the late stages, but we are coming to the later stages and I think soon a conclusion from our dose optimization work that we've been doing across the 8.6 and 10 mg/kg AIBW schedules, Q3 week schedules. So until we really pin that down, hard to say for sure, but I think it's not unlikely that we would be using AIBW moving forward in those additional combination studies.
Edward Tenthoff
Yes, makes sense. Thanks. Keep up the important work.
Sean McCarthy
Thanks, I appreciate the support.
Operator
Our next question comes from the line of Anupam Rama with J.P. Morgan.
Anupam Rama
This is Brooke on for Anupam. What drove the shift of the monotherapy update from year-end '26 to January? Is it more patient follow-up or waiting on FDA feedback? Thank you.
Sean McCarthy
Yes, as dose optimization has continued, we've really wanted to allow time for sufficient follow-up to assess safety and efficacy and also allow for the full engagement and feedback from regulatory authorities. We are looking forward to the update in January.
Operator
Our next question comes from the line of Roger Song with Jefferies.
Nabeel Nissar
This is Nabeel on for Roger. A couple from us. I guess regarding GI durability, it's encouraging to see the 10% Grade 3 in the 2 months as we get longer follow-up. I was just curious how you're thinking on time of onset, duration, and recurrence. And then as we go into second line, you mentioned earlier with 5-fluorouracil, we know that that may add some toxicity. We know that, as you mentioned, irinotecan is already used in second line. But what's the target for the GI toxicity that we're looking for?
Sean McCarthy
Yes, thanks, Nabeel. Great questions. And as I mentioned earlier, we're continuing to learn a lot about the safety profile of Varseta-M. And we did, as you also rightly point out, in March this year, report our initial experience in dose optimization, showing that after 2 months of matched follow-up with the patients in dose optimization cohorts, the first 20 patients in dose optimization cohorts across the 2 doses of 8.6 and 10 mg/kg, a rate of Grade 3 diarrhea of 10% relative to more than 30% in the time-matched patients from escalation and expansion. So an encouraging start.
I think we've been pretty consistent in talking about our goal for Grade 3 diarrhea based on work that we've done talking to oncologists and other market research that we've done, that we would like to manage the rate of Grade 3 diarrhea to 20% or below. We think that that is a more than acceptable rate in this disease. Obviously, we want to do the best we can in terms of leveraging the prophylaxis strategy, which in the March update was certainly showing a very good start.
Just a little bit more detail. Let me go into a bit more detail, since you mentioned time to onset, we've reported previously that time to onset for Grade 3 diarrhea with Varseta-M at these doses is about 5 weeks. And we've reported that it does not appear to be cumulative. We've also spent a lot of time over the last few months looking not just at the grade, but also digging deeper into the patient experience in terms of what is the amount of time that a patient spends in Grade 3 and what is the burden overall. And that's something that we'll have more to say about over time.
And the reason I point that out is that, of course, the goal of managing really this 1 significant AE that we have to think about with Varseta-M. The safety profile of Varseta-M overall we think is highly attractive, but our goal in managing the high-grade diarrhea is, of course, to maximize dose intensity. And we do anticipate that dose intensity will be an important determinant of efficacy, particularly in regards to PFS and OS over time. So ongoing work, and we continue to learn more all the time, and we'll look forward to providing the update in January. Thanks for the questions.
Nabeel Nissar
Yes, thank you, Sean. If I could ask a follow-up.
Sean McCarthy
Yes, go ahead, Nabeel, please.
Nabeel Nissar
So kind of taking a step back, we see the ESMO updates, encouraging to see more progress being done here. Curious if we take a step back and look at just the target itself, EpCAM, compared to targeting CEACAM5, both are glycoproteins. Can you comment on the rate of shedding compared to CEACAM5 for EpCAM? We know that CEACAM5 is more readily shed into the bloodstream. And do you think that in that regard, EpCAM has a more favorable target profile?
Sean McCarthy
Well, we do see EpCAM, I would say, compared to CEACAM5 being somewhat more highly and broadly expressed, although CEACAM5 is an abundant and broadly expressed target, which the data that I've seen is not so far from patients that have been selected for target expression, but we do continue to like EpCAM quite a bit as a target. In terms of shedding, I don't really have anything to say there in terms of comparison across the targets. And it's not, to be honest, something that we've spent a lot of time thinking about, but maybe we'll come back to you on that.
Operator
Our next question comes from the line of Olivia Brayer with Cantor Fitzgerald.
Olivia Brayer
I wanted to follow up on the January timeline or timing. Can you disclose what follow-up threshold you guys are looking to achieve, especially as you think about safety follow-up, but also thinking through survival and is this more about accruing events over time? I guess I'm trying to understand whether it's more about the dose expansion population or the 40-patient dose optimization cohort.
Sean McCarthy
Yes, hi, Olivia. So we've, I think, again, been pretty consistent here for a while now in terms of our goals and strategy for data disclosures. If we go back, I guess, a year or a year and a half, when we were approaching the data coming out from escalation and expansion, we communicated that we would share those updates, which we did in March this year, when we had an initial sense of progression-free survival on a dose-by-dose basis. With regard to the optimization data, similar guidance that we want to be able to share PFS from the optimization cohorts in the context of the first look at OS from escalation and expansion. So the January update, as I mentioned earlier on, is simply to allow sufficient time to give as robust an update as we think is appropriate.
Olivia Brayer
Helpful. And then, Sean, on the optimization cohort, how are you guys thinking about breaking out efficacy between patients who received an AIBW-adjusted dose and those who didn't? And I'm not sure if you can share this number, but any sense of what proportion of those 40 patients actually required a meaningful dose adjustment?
Sean McCarthy
Well, every patient's dose would have been calculated using the AIBW algorithm. I think it's a good question, but I would reframe it a little bit in terms of ultimately what's the dose, well, of course, what's the absolute dose that a patient receives and what's the dose intensity achieved over time? And that's the type of data that we're going to be analyzing and that we will be sharing in due course.
Olivia Brayer
Okay, understood. Looking forward to it. Thank you very much.
Sean McCarthy
You're welcome.
Operator
Our next question comes from the line of Kalpit Patel with Wolfe Research.
Unknown Speaker
This is Nikki on for Kalpit. I wanted to ask if, as you gain additional experience with the optimized dosing regimen, would you be able to give us any granularity on what that selected dose might be for the Phase 3 or what you're leaning towards? Thank you so much.
Sean McCarthy
Yes, thanks for the question. Can't provide any additional color at this moment in time, but that will be an important component of the update in January.
Operator
Thank you. 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.
Sean McCarthy
Thank you, and thanks, everyone, for listening in today. We continue to be highly encouraged by the progress we're making here at CytomX with Varseta-M, with CX-801, and more broadly with our ProBody therapeutic platform. We're excited about the breadth of opportunities in front of us as we drive toward the end of the year and rapidly, as it seems, into 2027. So thank you all for your time today.
Operator
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
This live transcript is auto-generated without human intervention or review.
本文部分內容由 AI 生成和翻譯,並經人工審核,僅供參考且做為一般資訊用途,不構成投資建議。






