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DATE

Thursday, May 7, 2026 at 5 p.m. ET

CALL PARTICIPANTS

  • Chairman & Chief Executive Officer — Sean McCarthy
  • Chief Financial Officer — Chris Ogden

TAKEAWAYS

  • Varseta-M Phase I Data -- Confirmed overall response rate (ORR) between 20% and 32%, and approximately 7 months median progression-free survival (PFS) in late line metastatic colorectal cancer, based on March 2026 update.
  • Enrollment Milestone -- Dose optimization cohorts completed enrollment with 40 patients across 8.6 mg/kg and 10 mg/kg dose levels; total Phase I enrollment now 113 patients.
  • Safety Profile -- Early dose optimization shows high-grade (Grade 3) diarrhea incidence of 10% in the first 20 patients after management improvements, with updated strategies targeting a 10%-20% range for this adverse event as more data mature.
  • Registrational Study Timeline -- Plans to begin Varseta-M late line colorectal cancer registrational trial during the first half of 2027, pending dose selection and ongoing FDA interactions.
  • Combination Therapy Development -- Advanced planning for Varseta-M administration with bevacizumab as an early line colorectal cancer therapy, with initial clinical data expected by the first half of 2027.
  • CX-801 Progress -- Phase I dose escalation for CX-801, a masked interferon alpha-2b for PD-1 refractory melanoma, now exceeds approved unmasked interferon dose with the program described as "well tolerated to-date".
  • Financial Position -- Quarter-end cash, cash equivalents, and investments of $346.7 million as of March 31, 2026, up from $137.1 million at prior year-end, with guidance that current runway extends at least through the second half of 2028 without requiring new business development or collaboration milestones.
  • Revenue -- Total revenue of $10.3 million, down from $50.9 million in the same quarter last year, attributed to the completion of obligations under prior Bristol Myers Squibb and Amgen collaborations.
  • Operating Expenses -- $29.8 million in quarterly operating expenses versus $28.3 million in the prior year, with R&D spend at $19.2 million and G&A at $10.6 million, both influenced by one-time restructuring expenses in 2025 offsetting the year-over-year increase.
  • Upcoming Data Updates -- Company will provide comprehensive safety and efficacy update for Varseta-M dose optimization cohorts, including subgroup demographics and initial PFS, in the second half of 2026, with first look at overall survival primarily from escalation and expansion phases.

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RISKS

  • Revenue declined by $40.6 million in Q1 2026 compared to Q1 2025, attributed to the completion of collaboration obligations.
  • High-grade diarrhea remains a principal adverse event for Varseta-M. There is ongoing uncertainty until full 40-patient optimization data are available; the company targets but has not yet achieved a 10%-20% rate for this toxicity.

SUMMARY

CytomX Therapeutics (CTMX 0.50%) presented detailed clinical progress of Varseta-M in late line metastatic colorectal cancer, emphasizing its unique competitive positioning as the only EpCAM-directed ADC in clinical development. Management described a robust enrollment pace and identified dose optimization as central to FDA alignment for an upcoming registrational trial targeted for launch in the first half of 2027. The company signaled expansion initiatives for Varseta-M both as a monotherapy in new tumor types and in combination with standard combination regimens in earlier colorectal cancer therapy lines. There is disciplined capital allocation, with a strengthened balance sheet supporting clinical milestones through at least the second half of 2028 in the absence of additional external funding or partnership revenue.

  • Initial CX-801 clinical data in advanced melanoma, both as monotherapy and in combination with KEYTRUDA, are expected by the end of 2026, with observed tolerability at doses surpassing the approved unmasked interferon alpha-2b level.
  • "We can treat every patient. We're not selecting patients. We don't need to select patients," said McCarthy, positioning Varseta-M as a potential all-comer late line CRC therapy.
  • Upcoming comprehensive data releases will inform final dosing decisions and registrational study design. Subgroup and survival analyses are prioritized for transparency.
  • Management clarified that revenue expectations do not depend on unplanned milestone payments or new partnerships, underscoring forward-looking financial stewardship amid increased operating expenses for clinical program acceleration.

INDUSTRY GLOSSARY

  • EpCAM: Epithelial cell adhesion molecule, a cell surface protein overexpressed in many epithelial cancers and used as a target for antibody drug conjugates.
  • ADC: Antibody drug conjugate, a therapeutic modality combining an antibody specific to cancer cells with a cytotoxic drug.
  • PFS: Progression-free survival, a clinical trial endpoint measuring time from treatment start until disease progression or death.
  • ORR: Overall response rate, percentage of patients with a predefined reduction in tumor burden.
  • PROBODY: Proprietary CytomX platform enabling conditional activation of antibodies to reduce off-tumor toxicity.

Full Conference Call Transcript

Sean McCarthy: Thanks, Chris, and good afternoon, everyone. We're very pleased to be here today to provide an update on our first quarter developments and guidance for what's continuing to be a transformational year for CytomX. 2026 is off to a very exciting start, driven by our excellent clinical progress with Varseta-M in late line colorectal cancer. Varseta-M is a first-in-class EpCAM targeting antibody drug conjugate, or ADC, that was uniquely designed and enabled by our proprietary PROBODY therapeutic masking platform. Varseta-M is the only EpCAM-directed ADC in clinical development to our knowledge, affording us a strong lead and a powerful competitive advantage.

EpCAM is one of the most abundant solid tumor surface antigens and CytomX's breakthrough in unlocking EpCAM as an ADC target positions Varseta-M as a company-building asset over the near and long-term. We see multiple layers of value creation potential for CytomX through the advancement of Varseta-M. In colorectal cancer, which I'll now refer to as CRC, our goal is for Varseta to become a core component of the standard of care, including in earlier line therapy. Metastatic CRC remains one of the largest areas of unmet need in oncology today, which really underscores the urgency we feel at CytomX to progress Varseta-M towards the market as rapidly as possible.

Commercially, in the late line setting alone, this represents a multibillion-dollar market. In addition to the very substantial opportunity in CRC, we also plan to capitalize on our leadership in EpCAM targeting by developing Varseta-M in other cancers and ultimately as a pan-tumor therapy. Varseta has the long-term potential to positively impact the lives of so many people with cancer, and we are focused on executing with urgency to rapidly progress this potential therapy to regulatory approval. CytomX has made a very strong start in the clinic with Varseta-M.

In our most recent Phase I data update in March this year, we shared updated efficacy data in late line metastatic CRC, showing a confirmed overall response rate between 20% and 32% and approximately 7 months of median progression-free survival. These data position Varseta as a potentially transformative step forward in the treatment of metastatic CRC, where currently available therapies offer overall response rates only in the low single digits and just a few months of PFS. Varseta-M is working exactly as designed, and it's unlocking the true potential of EpCAM for the first time. With Varseta, CytomX is bringing the power of the ADC class to colorectal cancer.

I want to really underscore here that we've achieved something very significant with our PROBODY platform technology. In our view and based on our preclinical data and efforts of others over many years, we believe we can say with confidence that a conventional unmasked ADC targeting EpCAM would have no chance of achieving dose levels that deliver meaningful anticancer activity due to severe on-target toxicities. In contrast with Varseta-M, we have achieved remarkable anticancer activity in one of the hardest-to-treat cancer types. We firmly believe we have done the hardest experiment first by focusing initially in CRC and that the best is yet to come.

In terms of key near-term objectives for Varseta-M, we are currently in dose optimization with the goal of advancing into a registrational study in late line CRC in the first half of 2027. Today, we're very pleased to share that we have completed enrollment in the ongoing dose optimization cohorts with 40 total patients now enrolled across the 8.6 and 10 milligram per kilogram doses, taking total enrollment across the Phase I study to 113 patients. We remain well on track for an update before the end of this year as we work towards prioritizing 1 of these 2 doses of this highly active drug candidate for our first pivotal study.

In evaluating the potential registrational study dose, we're focused on optimizing the risk benefit of Varseta-M, building on the significant learnings in the dose escalation, expansion and optimization phases. Regarding Varseta-M safety, we have been highly encouraged by the preliminary results we shared in March from dose optimization that show that updated patient management strategies have the potential to substantially reduce the rate of high-grade diarrhea we saw earlier in Phase I development. This is the principal adverse event of interest with Varseta, and it's something we feel confident we can get an increasingly well-developed understanding of as we move forward through the optimization cohorts and beyond.

Typically, patients respond very well to management and our overall discontinuation rates are low, accounting for the impressive progression-free survival data we have shared to-date. In terms of our next clinical communication, we expect to provide an overall Phase I data update, including safety and efficacy from the monotherapy dose optimization in the second half of this year. We expect these data, along with FDA interactions in 2026 to inform Varseta-M monotherapy dose selection and the first registrational study design. Our primary goal with Varseta-M is initially to develop in the late line where we see this drug candidate as highly differentiated and frankly, as offering a highly impactful new option for CRC patients.

Over time, our vision for Varseta in CRC is to replace systemic irinotecan in the treatment paradigm and potentially to displace chemotherapy entirely. Accordingly, and in parallel to its development as a monotherapy in CRC, we are aggressively advancing Varseta-M into combination studies to enable earlier line utilization. Strategically, we see an enormous opportunity for Varseta in early line CRC. To access this opportunity, we have initiated a combination with bevacizumab as a first step to moving Varseta into earlier line therapy. Anti-VEGF antibodies, including bevacizumab are extensively utilized in early and late line CRC treatment. So this will be a foundational combination.

Varseta-M doses assessed in combination with bevacizumab will include both every 2 weeks and every 4 weeks schedules to align dosing with the approved 5 mg per kg every 2-week schedule standardly used in the clinic today. We expect initial clinical data for this combination by the first half of 2027. We're also accelerating plans to study Varseta in combination with chemotherapy, and we plan to begin a Phase I/II chemotherapy combination study in the second half of 2026, evaluating Varseta in combination with bevacizumab by fluorouracil and leucovorin with the potential to advance into the first and second lines.

In addition to our work in colorectal cancer, we are on track to begin Phase I expansion cohorts in additional EpCAM-expressing indications in the second half of 2026. We look forward to providing an update on the initial non-CRC indications later this year with the goal of generating clinical data supporting Varseta's ultimate pan-tumor potential. Turning now to CX-801, our masked interferon alpha-2b program, which is currently in Phase I development for advanced checkpoint refractory melanoma. Our vision here is for CX-801 to become a new centerpiece for combination cancer immunotherapy as we harness and redirect the power of this cytokine to reprogram and activate antitumor immunity.

We initially see CX-801 as well positioned to address the high unmet need in PD-1 refractory melanoma where response rates to approved standard of care remain in the single-digit percentages with limited treatment options available or in clinical development. Interferon alpha-2b is a potent cytokine that has validated clinical activity in melanoma and other cancers and our initial translational data from Phase I suggests that CX-801's mechanism of action is working as designed in the tumor microenvironment. Importantly, our data shared at SITC in 2025 are highly supportive of our strategy for combining with the checkpoint inhibitor, KEYTRUDA.

Our ongoing CX-801 Phase I monotherapy dose escalation study has advanced to the fourth dose level, which exceeds the approved clinical dose of unmasked interferon alpha-2b. CX-801 has been well tolerated to-date, suggesting that our masking strategy is broadening the therapeutic window as designed. Combination dose escalation with KEYTRUDA is also progressing very well and is now actively enrolling in the third dose level. Overall, we view CX-801 as very well positioned to address a significant unmet need in advanced melanoma, and we look forward to sharing initial clinical data by the end of this year. With that, I'll now transition back to Chris.

Chris Ogden: Thank you, Sean. Reinforcing Sean's earlier sentiment, we kicked off 2026 from a position of strength, not only with Varseta-M's encouraging data, but with the financing completed in March, a strong balance sheet that enables us to continue to execute against the significant value creation potential of Varseta and the PROBODY platform. CytomX is in a strong financial position with projected cash runway to at least the second half of 2028 and the potential to achieve multiple milestones. Of note, our runway guidance does not include any supplemental milestones from existing collaborations or any new business development.

Importantly, we expect our current cash position will enable us to advance Varseta-M into a registrational study in late line CRC, also deliver safety and efficacy data for Varseta-M in combination with bevacizumab as well as Varseta-M data in combination with chemotherapy and deliver initial clinical data for Varseta-M in indications beyond CRC. Based on these opportunities, which have the potential to yield significant long-term commercial potential, we expect our capital allocation to be highly focused on Varseta-M over the near to medium term. With that, I'll now walk through our first quarter financial results.

As of March 31, 2026, we ended the quarter with $346.7 million in cash, cash equivalents and investments versus $137.1 million in cash as of December 31, 2025. Looking at revenue and operating expenses for the quarter, total revenue was $10.3 million compared to $50.9 million in the first quarter of 2025. The decrease in revenue was primarily attributed to the completion of obligations in 2025 under collaborations with Bristol Myers Squibb and Amgen. Operating expenses for the first quarter were $29.8 million compared to $28.3 million in the first quarter of 2025.

R&D expenses were $19.2 million during the first quarter, representing an increase of $0.4 million versus the first quarter of 2025, primarily due to increased manufacturing activities for Varseta-M, partially offset by $1.8 million in restructuring expense incurred in the first quarter of 2025. G&A expenses increased by $1.1 million during the 3 months ended March 31, 2026, to $10.6 million compared to $9.4 million for the corresponding period in 2025, which included $1.1 million of one-time restructuring expenses. As we move throughout the remainder of 2026, we will continue to be disciplined in our capital allocation and advancing the highest Varseta-M priorities for patients and CytomX stakeholders. With that, I'll turn the call back to Sean for closing remarks.

Sean McCarthy: Thanks, Chris, and thanks, everyone, for joining us today. We're very proud of the remarkable progress we've made with Varseta-M, and we're now in the privileged position of bringing the transformative potential of an EpCAM directed antibody drug conjugate to colorectal cancer patients. We look forward to providing additional updates as the year progresses and as the development program for Varseta-M broadens substantially. We also remain focused on the advancement of the clinical program for CX-801 with the initial goal of delivering a more effective treatment option for patients with advanced melanoma. Before I conclude today's call, I want to sincerely thank and recognize the patients who join our studies, their families, our clinical investigators and our dedicated CytomX team.

With that, operator, let's go ahead and open up the call for Q&A.

Operator: [Operator Instructions] And our first question will come from Paul Jeng of Guggenheim.

Paul Jeng: So for Varseta-M, can you just talk a little bit about the scope of the clinical update you'll have in the second half? Will some or most of the dose optimization cohort patients have sufficient follow-up for PFS? Do you plan to break down responses by subgroup such as third line versus fourth line plus of therapy? And then how are you thinking about initial disclosures of overall survival from the study?

Sean McCarthy: Yes. Thanks, Paul, for the questions. So we are expecting that the update in the second half will be fairly substantial. As we've mentioned today, we've now enrolled 113 patients across the dose escalation expansion and now optimization phases of the study. So this is a very rich data set that is emerging for our first evaluation of Varseta in CRC patients. So in terms of the update, it will be across the entire study. It will include data from the full 40 patients optimization phase. And yes, we expect to have a reasonable follow-up in terms of safety and efficacy for the optimization patients, including, I would think an initial estimate of PFS.

As you'll recall, last year, our guidance as we came through the second half of 2025 was that we wanted to communicate data this year when it was mature and meaningful, and that continues to be the case and continues to be our philosophy. In terms of subgroups, yes, we'll certainly communicate the demographics of the patient population that we're enrolling. We do expect it to look quite similar to the patient population that we enrolled in the escalation and expansion phases. And I want to emphasize that one of the really differentiating and distinguishing features of Varseta-M as a drug for colorectal cancer is that we can treat every patient. We're not selecting patients.

We don't need to select patients. This really is a drug for all-comer late line CRC. And we see this as potentially a huge competitive advantage as we move the drug toward the market. In terms of the third component of your question and overall survival, yes, we absolutely anticipate having or providing, if you like, a first look at OS in this update in the second half of the year.

Operator: And our next question will be coming from the line of Edward Tenthoff of Piper Sandler.

Edward Tenthoff: Really excited for more data looking in the back half. I just had one quick clarification question on 1-2 chemo combo. Will that be triplet? So will you have -- or I guess, quadruple with the 2 chemos? And will that include Avastin? And do you need any of the Avastin combo data to start that chemo combo trial? I just want to make sure I understand that correctly.

Sean McCarthy: Ted, thanks for the question. Taking the first question first in terms of the nature of the combination, yes, we absolutely will want to evaluate the Varseta-M plus chemo plus bev combination. We will want to look at that. Right now, we don't see the data from the ongoing -- sorry, Varseta-M plus bev as gating necessarily to starting that work in the second half. We do, of course, see that bev combination work -- the Varseta-M/bev combination is going to be really important to further down the road, considering from a registrational study perspective, the design of that study, if indeed we do, at some future point, decide to compare Varseta-M plus bev against other comparator arms.

But we do plan to look at that triplet in the chemo combination later this year.

Edward Tenthoff: Yes. And then that's really helpful. And then when it comes to the new EpCAM positive tumors, I'm really excited to hear what you're thinking is. Maybe you can share with us now kind of what goes into some of that prioritization because there's a lot of different places you could go?

Sean McCarthy: Yes, there are so many places we could go because EpCAM is such a broadly expressed cancer target on so many solid tumors. So we do have a lot of opportunities to work through and prioritize. It's not lost on us, of course, or really anybody else that there are some -- there's quite a number of, if you like, adjacent GI tumors that can make a lot of sense to evaluate with Varseta-M. There are also many others. So something that we continue to work through and prioritize, and we will communicate more specificity on exactly what we're planning to do in the second half.

Operator: [Audio Gap] line of Anupam Rama of JPMorgan.

Unknown Analyst: This is [ Joyce ] on for Anupam. I think previously, you had said you were targeting midyear FDA interactions to start discussing the pivotal trial design. To what extent is reaching alignment on the trial design ultimately gated on seeing your dose optimization update later this year? I think you can start having those conversations with FDA now with your initial data in hand. So just how should we think about the update later this year in terms of solidifying your registrational strategy?

Sean McCarthy: Yes. Thanks. Great question. Really important question. And I'll start by saying that we're just really excited to have this dialogue with FDA as we progress through the year. We anticipate multiple interactions. And we do expect that the data from the optimization cohorts will be central to those conversations in relation to dose selection for the first pivotal study. That's, of course, a large part of the reason we're doing these additional 2n equals 20 cohorts at the 8.6 and 10 mg per kg doses is to generate data to satisfy Project Optimus and have a highly productive a conversation with FDA as we can.

So yes, that data will be important, and that's why we're guiding that really towards the end of the year or by the end of the year, the next comprehensive update that we plan to provide will not only include, of course, data across the 113-patient Phase I study, but will also include guidance as to where we're going next in terms of design of the first pivotal study, what the patient population is, what the comparator arm is and of course, what the dose is.

Operator: And our next question will be coming from the line of Roger Song of Jefferies.

Nabeel Nissar: Congrats on the progress. This is Nabeel on for Roger. Maybe one for me first. So just on the 8.6 versus 10 mg per kg, just a little bit curious if you could maybe give some color on the dose decision logic because we saw the headline ORR of 32% versus 20%. But what is the framework that you guys would apply to finally lock in on a dose? Or is it related to tolerability at this point? Because we noticed in the exposure response model, it looks like there's pretty similar efficacy. So are you weighing depth and durability? Are you weighing safety more?

Sean McCarthy: Yes. Thanks, Nabeel. That's obviously -- there's a lot in that question in terms of the work that we are doing in real time, and we'll be continuing to do as we move through the year to lock in on the go-forward dose. And first thing I'll say is we think we've got 2 great choices here in terms of the 8.6 and 10 mg per kg doses, both of which, as you'll recall, we're currently evaluating on an adjusted ideal body weight basis in the context of the dose optimization cohort.

So we're going to learn a lot as the year goes by as to the performance of these 2 doses, of course, in terms of efficacy, also in terms of safety. And on efficacy specifically, as we've been discussing for quite some time now, we do anticipate that at least our base case for our first registrational study, we do anticipate that overall survival will be our primary endpoint. And that, of course, means that ORR is really an important metric here for how the drug is performing, and this drug is performing extraordinarily well, as you said, 20% ORR at 8.6%, 32% at 10 MPK, that is remarkable activity.

But we also have remarkable progression-free survival of 7 months as reported on March 16, and we are very keen to see how that translates into OS as the data matures with OS, of course, as I just mentioned, being our primary and most likely primary in the go-forward pivotal study. So we'll see. We'll see how these 2 doses deliver in terms of all of these different metrics, and we'll choose accordingly.

Operator: And our next question will come from the line of Olivia Brayer of Cantor Fitzgerald.

Olivia Brayer: For that second half data disclosure, can I just clarify that you guys plan to break out tolerability and efficacy for those 40 patients specifically in the optimization cohort? And if so, will we still get PFS and potentially even an early look at some OS data from those patients specifically? And then from a timing perspective, top line second half of this year, does that mean you'll likely follow it up with a presentation at a medical conference sometime in early 2027? And then I've got one quick follow-up on the new formulation with bev.

Sean McCarthy: Yes. Thanks, Olivia. So yes, obviously, the 40 patients optimization cohorts is of high interest to us and others. And so we absolutely plan to report the full safety picture, which we gave an early look at in the March 16 disclosure. We gave an early look at the first 2 months of experience, which is very encouraging. So we plan to give a similar look for the full 40 patients by the end of the year, together with efficacy. And as I've already mentioned, PFS would certainly be a goal there to have PFS for those 40 patients. I think OS is going to be too early.

We're just -- as we've reported today, we've completed enrollment, but that's been relatively recent. So I think OS is going to be immature. But we do anticipate having OS from the escalation and expansion phases, which I think will be particularly telling because remember that in those patients, those first escalation and expansion patients, we have not optimized our adverse event management plan, but we were still able to deliver 7 months of PFS, and we're optimistic that we'll have an encouraging OS number as we get to report that later in the year. In terms of venue for data updates, we do think a medical meeting this year is on the cards.

Certainly, as we move into 2027, additional medical meetings, we're, of course, keeping our options open.

Olivia Brayer: Okay. Very helpful. And then for the combination with bev, is there anything you guys can tell us at this point about the formulation work that you've done to get Varseta-M administered as an every 2 and 4-week dosing schedule instead of every 3 weeks? Or is there any data that you'll be sharing there at some point?

Sean McCarthy: Well, there's no real formulation work that needs to be done. It's simply an adjustment of the schedule from Q3 to Q2 and then accordingly to Q4. And that's to match the -- as I just mentioned on the call, that's to match the established clinical use of bev in the FOLFOX/FOLFIRI setting on a 2-week schedule. So there's no additional formulation. It's simply a question of adjusting the frequency of dosing to match the use of bevacizumab in the marketplace today.

Operator: And our next question will come from the line of Matt Biegler of OpCo.

Matthew Biegler: Just kind of curious how you're seeing the emerging competitive profile here of Varseta-M versus the other ADCs that are also in development, Precem-TcT being one of them. And then I guess more importantly, do you think this is like a winner takes all, zero-sum game here with the Topo-1-based ADCs? Or do you think different patients might get different ADCs depending on certain health status, et cetera?

Sean McCarthy: Thanks, Matt. Well, we certainly don't see this as winner takes all by any means. And I think that would be a very unusual scenario for an oncology drug in this class in an area of unmet need like this. I mean, our thinking is very different on that question. So first of all, with regard to Varseta-M, we have a first-in-class anti-EpCAM antibody drug conjugate. And again, I really can't emphasize how important it is to realize that we've done something really, really -- I'll use the word special with our technology to unlock the potential of EpCAM for the first time with our PROBODY therapeutic platform.

Secondly, we really do believe that Varseta-M has the potential to be the best-in-class ADC for colorectal cancer. This drug is highly active. It's highly active in terms of its response rate. It's highly active in terms of its progression-free survival, and we'll see what it can deliver in terms of overall survival as we move forward. This is a very active drug, and we believe does have the potential to be best-in-class. So we're going all out with this drug to get it to the market as quickly as we can. We think it's highly competitive.

And we think there's a ton of value to build in our company with this drug, most importantly, an enormous amount of benefit to bring to these patients.

Operator: [Operator Instructions] Our next question will be coming from the line of Mitchell Kapoor of H.C. Wainwright.

Unknown Analyst: This is [ Yan Zi ] sitting in for Mitchell. I was wondering, could you break -- so actually, with the enrollment now complete in the 40 patients dose optimization cohort, can you give any update on whether Grade 3 or higher diarrhea in the optimized adjusted ideal body weight plus prophylaxis population is still tracking closer to that initial 10% rate that was seen in the first 20 patients or whether it moves closer to something like the historical 25% to 30% range at the 8.6 and 10 mg per kg as follow-up has occurred?

Sean McCarthy: Well, no new data today. That data will be coming. We're obviously -- we're highly encouraged by the initial data we presented on March 16 from the first couple of months of follow-up of the first 20 patients enrolled into the optimization cohorts with a rate of Grade 3 diarrhea of 10%. I think we commented at the time, and we've been very consistent about this over the last few months that our objective is, of course, to manage the rate of Grade 3 to the best of our ability with this updated AE management strategy that includes upfront use of loperamide and budesonide.

It appears to be performing very well as of that first data update, and we're encouraged to see additional data now from the full 40 patients. That data will be shared later in the year. Our goal overall is to manage the Grade 3s into the 10% to 20% range. That we think is really the target. And that's based on our own research. It's based on a lot of conversations we've had. And quite honestly, a lot of work that's been published and presented by others over the last 6 or so months.

So we're -- we feel we're very much on track, as I said in my prepared remarks, to get a strong handle on that particular aspect of the Varseta-M program.

Unknown Analyst: I see. Curious also, so for an optimized regimen, how standardized is prophylaxis practice? Do you see any implementation friction that could matter in a community oncology setting if, for example, Varseta-M moves earlier in late line CRC?

Sean McCarthy: We really don't. The upfront work that we're doing right now with these optimization cohorts is absolutely intended to pin down a prophylaxis strategy that will be readily translated into the community setting as we move into our first pivotal study and of course, as we bring the drug to the market. So it's a good question. It's an important question, and it's one that we've asked ourselves, and that is, again, just to restate a big part of why we're doing this upfront optimization work right now.

But we -- right now, we don't see any challenges with the translation, if you like, of this updated AE management plan into a larger number of sites and ultimately into the commercial marketplace.

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

Sean McCarthy: Thank you. And again, I'd just like to thank everyone for joining us today. We're very excited about our progress here. I hope that comes across. And we really look forward to providing additional updates as the year progresses.

Operator: And this concludes today's program. Thank you for participating. You may now disconnect.