CytomX Therapeutics, Inc. (CTMX) Earnings Call Transcript & Summary

Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeutics Second Quarter 2026 Financial Results Call. Please be advised that today's call is being recorded. I would now like to hand the call over to your host for today, Chris Ogden, CytomX Chief Financial Officer. Please go ahead.

Thank you. Good afternoon, and thank you for joining us. Before we begin, I would 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. 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 second quarter 2026 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. 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 will then conclude with a Q&A session. With that, I'll turn the call over to Sean.

Thanks, Chris, and good afternoon, everyone. We're pleased to be here today to provide an update on our second quarter developments and what continues to be a highly productive year for CytomX. Our major focus continues to be Varseta-M, our first-in-class EpCAM-targeting antibody drug conjugate, which, to our knowledge, is the only EpCAM-directed ADC in clinical development. We are aggressively developing Varseta-M in metastatic colorectal cancer, which I will refer to as CRC. The unmet need in CRC is very high and in fact, projected to grow due to increased incidence in younger patients on a global basis. We view Varseta-M as a highly innovative drug candidate for the treatment of CRC and potentially the best-in-class ADC based on our clinical data reported to date. The Varseta-M development program is broadening rapidly, and we see significant value creation potential across our key priorities, which include: first, advancing Varseta-M toward a registrational study and potential approval as a monotherapy in late-line CRC. Second, developing Varseta-M in combinations to expand into earlier line CRC with a vision to ultimately replace chemotherapy; and third, exploring Varseta-M as a pan-tumor therapy across multiple EpCAM-expressing cancers. In terms of our operational progress this quarter, I'll start with Varseta-M monotherapy development in late-line CRC. We have enrolled 113 patients into the overall Varseta-M Phase I monotherapy study across dose escalation, expansion and optimization. Enrollment in dose optimization was completed in April with a total of 40 patients enrolled across the 8.6 and 10 milligram per kilogram doses, utilizing adjusted ideal body weight dosing. We remain on track to report by the end of 2026, a Phase I data update for Varseta-M across the entire ongoing Phase I trial with a key focus on the data that underpins monotherapy dose selection and the go-forward development strategy for our first registrational study that we aim to initiate in the first half of 2027. We continue to see monotherapy registrational strategies in either the third or fourth line, depending upon emerging data, as compelling opportunities, and we look forward to communicating our strategy later this year. In addition to monotherapy development, we are aggressively advancing Varseta-M in combinations to enable earlier line CRC therapy, and we have made significant progress this quarter. The first combination we're exploring in an ongoing Phase I cohort is with bevacizumab, a foundational component of current standard of care in CRC across early and late lines of treatment. We are exploring Q2-week and Q4-week schedules to align with the clinical schedule of bevacizumab. We continue to enroll late-line patients, and we expect to focus on earlier line patients once we have selected a go-forward dose and schedule. We anticipate reporting initial clinical data in the first half of 2027. Our second combination study that we plan to initiate in Q4 will be a new Phase I/II trial initially evaluating escalating doses of Varseta-M in combination with bevacizumab, 5-fluorouracil and leucovorin in second-line CRC patients. This study is central to our goal of replacing irinotecan with Varseta-M in earlier line CRC. I'd like to emphasize here that our work to date with Varseta-M has been conducted entirely in late-line unselected CRC patients. We've made terrific progress, and we view Varseta-M as a treatment for all patients with late-line CRC, including patients with liver mets, KRAS mutations and other clinically meaningful characteristics that in other settings are used to differentiate patients and their treatment options. We think this pan-CRC potential makes Varseta-M stand out from other treatment options. We look forward to building on our promising start by bringing Varseta-M forward as a potential frontline treatment option, ultimately replacing chemotherapy. Now moving to the development of Varseta-M outside of CRC. We're very excited today to announce that we are initiating Phase I expansion cohorts in additional gastrointestinal cancers. Initially, we are expanding into gastric and gastroesophageal junction cancer, pancreatic ductal adenocarcinoma and biliary tract cancer. These are all EpCAM-positive tumor types. And in each case, we see significant unmet need that Varseta-M could potentially address. We prioritize these tumor types based on a number of criteria, including their known responsiveness to topoisomerase-1 inhibition and our own Varseta-M preclinical data, and we believe these indications could offer compelling regulatory opportunities. Our initial plan is to enroll approximately 20 patients per tumor type to assess Varseta-M's antitumor activity and safety before assessing next steps and potential later phase development options. As a reminder, in colorectal cancer, we are enrolling an unselected patient population due to the uniformly high expression of EpCAM in this cancer type. For our newly selected GI expansion indications, we think patient selection is advisable in certain cases in order to enrich the patient population while we continue to learn about the relationship between target level and antitumor activity. For pancreatic and biliary tract cancer, we expect to screen patients for EpCAM expression. For gastric and gastroesophageal junction cancer, like CRC, we expect to enroll an unselected patient population given the high percentage of patients expected to have EpCAM-expressing tumors. Overall, we believe the successful execution of these expansion cohorts could further position Varseta-M as a pan-GI ADC, providing additional development opportunities across multiple lines of therapy. To summarize, we are very pleased with the continued progress with Varseta-M as this really exciting program deepens and broadens toward our first registrational study to earlier lines of therapy and into other GI cancers. We look forward to providing a further update by the end of the year. Now turning to CX-801, our masked interferon alpha-2b program being evaluated in checkpoint refractory melanoma. We see CX-801 as a new and exciting opportunity to reprogram the immune responsiveness of solid tumors, and we continue to be pleased with the progress of the ongoing Phase I study, both as monotherapy and in combination with KEYTRUDA. Starting with monotherapy, we've reached the fourth dose in dose escalation, and to date, CX-801 monotherapy has been generally well tolerated, including at dose levels exceeding those achieved with commercially available 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 make solid progress in the Phase I combination study and have now successfully cleared the third dose level, and enrollment is ongoing. We look forward to sharing initial clinical data from the Phase I study in melanoma in the first half of 2027. Before I turn the call to Chris to walk through financials, I'd like to highlight our continued additional progress across the organization. During Q2, we announced a major expansion of our collaboration with Regeneron, focused on next-generation masked bispecific immunotherapies. This is the result of our continued strong scientific momentum and represents validation of CytomX expertise in conditional activation, masking technologies and protease biology. We've also been very pleased recently to have strengthened the organization through key additions to the Board and executive team as we prepare CytomX for the coming phase of growth and development. In May, we were delighted to welcome Mamata Gokhale as our Senior Vice President of Regulatory Affairs. Earlier this week, we announced the appointment of Alejandra Carvajal as our new Chief Legal Officer. Additionally, as we approach late-phase development for Varseta-M in CRC, we are thrilled to have welcomed Dr. Charles Fuchs to our Board of Directors. Charles is a highly accomplished oncology leader, most recently serving as Chief Medical Officer of Tubulis. Prior to that, he held global oncology development -- he led global oncology development at Roche/Genentech after transitioning to industry from a long and distinguished career in academia as a global leader in gastrointestinal cancer. Welcome, everyone, to the CytomX team. With that, I'll now transition the call over to Chris.

Thank you, Sean. As Sean highlighted, we are making important progress across the increasingly broad Varseta-M development plan with capital allocated to unlocking multiple layers of value creation over the near and long term. With our current balance sheet, we project cash runway to at least the second half of 2028, which positions us to advance Varseta into its first potential registrational study, pursue combination development to bring Varseta-M into earlier line CRC and invest in the broader potential of Varseta in multiple EpCAM-expressing indications. With that, I'm going to walk through our second quarter financial results. As of June 30, 2026, we ended the quarter with $330.3 million in cash, cash equivalents and investments versus $346.7 million in cash as of March 31, 2026. The cash balance as of June 30, 2026, does not include the additional $37 million payment received from Regeneron in July following the selection of 2 additional targets under the expanded collaboration. Now looking at revenue and operating expenses for the quarter. Total revenue was $1.4 million compared to $18.7 million in the second quarter of 2025. The decrease in revenue was primarily attributed to the conclusion of the BMS collaboration in 2025 and for the Astellas collaboration in the first half of 2026. Operating expenses for the second quarter were $25.2 million compared to $19.9 million in the second quarter of 2025. R&D expenses were $17.6 million during the second quarter, representing an increase of $4.3 million versus the second quarter of 2025, primarily due to manufacturing activities for Varseta-M as well as increased personnel-related costs and general research and development expenses. General and administrative expenses increased by $1 million during the 3 months ending June 30, 2026, to $7.6 million compared to $6.6 million for the corresponding period in 2025. Increased G&A expenses were primarily driven by higher consulting spend. As we move through the second half of 2026, we will continue to be disciplined in capital allocation with a focus on progressing Varseta-M towards its first registrational study and accelerated investments to unlock the broader potential in the program. With that, I'll turn the call back to Sean for closing remarks.

Thanks, Chris, and thanks, everyone, for joining us today. We continue to be highly encouraged by the progress we're making with Varseta-M and the breadth of opportunities in front of us. CytomX is working diligently to execute toward multiple layers of value creation for Varseta-M, simultaneously advancing toward a potential registrational program in CRC, expanding into earlier line settings and further evaluating additional EpCAM-expressing gastrointestinal cancers. We also remain focused on advancing CX-801 and generating clinical data in patients with advanced melanoma to inform the next phase of development for this program. We look forward to providing additional updates by the end of this year as these programs continue to advance. Before I conclude today's call, I want to sincerely thank and recognize the patients who participate in our studies, their families and caregivers, our clinical investigators and our highly dedicated team at CytomX. With that, operator, let's go ahead and open up the call for Q&A.

[Operator Instructions] Our first question comes from the line of Michael Schmidt with Guggenheim.

Congrats on the progress. I had a question on these new studies. So in these GI cancer expansion cohorts, could you just comment a bit about how you're approaching dose selection here and to what degree you can implement learnings from that colorectal cancer experience? And then similarly, in the bevacizumab combination study in colorectal, are you -- maybe talk about how you're approaching dose selection for this combination? And are you implementing the same GI prophylaxis into these cohorts that you're doing in the monotherapy dose optimization cohorts?

Michael, thanks for the great questions. So first of all, we're obviously very excited to be moving into these additional GI indications with Varseta-M. As you know, the target is expressed not only in these other indications, but also in many other solid tumors. And so this is really just the beginning of the expansion of the program across multiple cancers over time beyond CRC. In terms of dose selection, obviously, these will be initially monotherapy cohorts and the dose selection, we're not commenting on just yet, but is informed absolutely by the escalation expansion and optimization work that we've done in colorectal cancer over the last year or two. In terms of the bev combination in CRC, as we've reported previously, we are exploring Q2 week and Q4 week doses to the schedules to align with the Q2-week bevacizumab schedule. That is -- the doses that we've started at there, it's obviously a dose-finding study to evaluate multiple doses of Varseta-M with bev over time. And -- but we didn't need to go all the way back to the beginning in dose escalation. So we actually -- we believe we started at meaningful doses of Varseta-M, and we're excited to see the data as it emerges, and we're on track, as we just commented, to present initial data in the first half of next year. And then to your last question on prophylaxis, yes, we are indeed utilizing the same loperamide, budesonide prophylaxis strategy in the bev combo study.

Our next question comes from the line of Edward Tenthoff with Piper Sandler.

I really just want to say congratulations on the success across the board from team to clinical to really everything you guys are just really growing this company nicely. I wanted to pick up on these combo CRC studies, appreciating that the first regulatory push is going to be monotherapy later lines. What do you see as sort of the path forward here with combo in earlier line CRC? Maybe you can just sort of lay out kind of when we could expect data and kind of what you see as the potential requirements for future studies there. I appreciate it.

Thanks, Ted. I appreciate the comments. So well, maybe beginning with the bev combination. There's a lot of different reasons that we're doing this work, of course, given how foundational bev is in the treatment of colorectal cancer across multiple lines, early and late. And so the study will open up multiple opportunities, potentially a third-line study and obviously enable work in the first and second line over time in combination with Varseta-M, potentially in combination with chemotherapy. So we do see this bev work that we're doing, as I know others do, as really foundational to broadening the program across multiple lines over time. We're also super excited to be getting the chemo combination going with 5-FU later this year, which is, of course, designed to bring Varseta-M into the -- initially into the second line to replace irinotecan where irinotecan FOLFIRI is most commonly used. It's not infrequently used in the front line, as you know, but most commonly used in the second line. So this irinotecan replacement strategy is really going to be enabled by this first step of the Phase I/II study that we'll launch in Q4. Obviously, a little too early to be able to comment on potential registrational paths in those earlier lines, but we do see that these combination studies unlock enormous potential in the coming years.

Yes, totally get that. And if I may, just one quick one for Chris. With the milestone or the payment from Regeneron in the third quarter, would that be recognized -- did you -- you didn't recognize that in the second quarter. Would it be recognized fully in revenues in the third quarter?

Yes. Great question, Ted. I mean, first, just to emphasize, we're obviously thrilled to be expanding the collaboration with Regeneron. It's based on a few hard years of work from the research team, and I think just a reflection of the foundational science. The payment, just as a reminder, was $37 million for 2 additional programs. So that takes our pro forma cash to about $367 million. That $37 million will be recognized as we do the work and make progress with Regeneron. And those obviously are preclinical projects, so do take a number of years. So I should expect that to play out over a few years at least.

Our next question comes from the line of Anupam Rama with JPMorgan.

This is Joyce on for Anupam. I know you've previously said that a 10% to 20% Grade 3 diarrhea rate would be acceptable for the late-line CRC population. I think there is a fear that if the rate is on the higher end of this range in your next update by year-end 2026, there could be a risk to moving the product upstream. Just how would you respond to this pushback?

So an area of the program that we're obviously highly focused on at the moment as we move through our monotherapy dose optimization cohorts where the -- as we reported in our data update in March, our early experience with the prophylaxis strategy of loperamide and budesonide was very encouraging with the rate of Grade 3 diarrhea after the first couple of months of experience having been brought down to 10%. So a really strong start. And yes, the work that we've done and I think that many others have done in looking at when we think about risk benefit of Varseta-M in the concept of Grade 3 diarrhea, that 10% to 20% number is what we've been discussing and others have been discussing with us. At the end of the day, I mean, this drug, when you think about the unmet need in not just the late line, but actually even in the earlier lines of CRC treatment where, for example, even in the second line, I don't think we can say that outcomes in the second line are terrific for patients today. It's all going to be about risk benefit. And we know we've got a very active drug here in Varseta-M that targets EpCAM with a topoisomerase 1 inhibitor and has shown just really impressive activity in a patient population so far, which has been, as we mentioned in our comments, really quite late line, more than half of our patients fourth line or later. So it's all going to be risk benefit. I think -- and this is going to evolve over time. I would also say that we will continue to learn more and more over time about the etiology of this adverse event, the etiology of diarrhea in these patients, time to onset, time to impact of prophylaxis, time to resolution. And this will be an ongoing element of the program that we'll continue, I think, to increasingly understand and manage. So we'll just keep doing that work.