Genmab A/S (GNMSF) Q1 2026 Earnings Call Transcript

Hello and welcome to the GenMAP's first quarter 2026 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GenMAP is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that GenMap may hold your personal data as indicated by you as a part of our investor relations outreach activities, in order to update you on GenMap going forward. Please refer to our website for more information on GenMap and our privacy policy. I would like to hand the conference over to our first speaker today, Jan van de Winkle. Please go ahead.

Hello, and welcome to our Financial Results Call for the first quarter of 2026. With me today is our Chief Financial Officer, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tai Yamadi, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. Let's move to the first quarter highlights. In Q1 2026, we continue to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. And importantly, we continue to invest with discipline in our medicines, in our pipeline, and in our future growth, fully in line with our capital allocation priorities. Even with these strategic investments, we grew operating profits. The quarter was also marked by progress in our mission to bring innovative medicines to patients. There are a few highlights I would like to mention. Abkinli continued to build positive momentum. We were very pleased to see the hospitalization recommendation removed from the Turtline Plus relapsed or refractory diffuse large B-cell lymphoma label. and we are on track with the integration of MIRIS. And we are approaching this with the same focus and discipline that we brought to Profound Bio. Finally, the breadth, depth, and potential of RINA-S continues to increase. The data we presented at STO in April further support the promise of RINA-S, including in combination with the standard of care therapies such as Bevacizumab. We are also making significant progress with our development plan, as you can see on the next slide. We anticipate starting two new Phase III trials for RINA-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers. These include a Phase III chemoreplacement trial in platinum-sensitive ovarian cancer and the first frontline trial for RINA-S in endometrial cancer. As we continue to explore new opportunities for RINA-S outside gynecological oncology with a phase 2 signal-seeking basket trial in advanced gastrointestinal cancers. Finally, I'm pleased to share an update on the ongoing phase 3 trial in second-line-plus platinum-resistant ovarian cancer on the next slide. Because recruitment has been much faster than expected, the Phase III Rainfall O2 trial has now completed enrollment. This important milestone brings forward the pivotal Phase III data for RNA-S in platinum-resistant cancer into 2026. This reflects strong investigator engagement, the significant unmet medical needs in this indication and the strength of our execution on one of our highest priority late-stage programs. So we can now look forward to two data sets in the second half of this year for RINA-S in platinum-resistant ovarian cancer and the opportunity for broader global regulatory filings earlier than anticipated. For both P2 Centromop and Epkinly, we are maintaining our guidance on the timing of data, as you see here. So the key takeaway is that 2026 continues to be a very catalyst-rich year for Genmop, with readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients. With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for AppKinley and DivDAC. Brad.

Thanks, John. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for TIBDAC and Epkinle reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake, and ultimately reach more patients. This performance, combined with our work this year to advance our portfolio and expand our footprint to reach patients in more markets, positions us well to deliver on our growth ambitions in 2026 and beyond. In the quarter, Epkinle continued to gain notable traction as the only bispecific approved in DOBCL and FL indications. Looking globally, Epkinle grew 52% year-over-year, reaching $137 million in sales. In the U.S., Epkinle continued to expand across both academic and community settings, and this growth reinforces Epkinle's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems. The recent approval of fixed duration of McKinley plus R-square and Second Line FL has been a growth driver for the brand and contributed positively to McKinley's growth in the quarter. The recent approval of in the quarter, we're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy, and proven safety with seamless subcutaneous administration. Looking ahead, we expect adoption in the community to continue to expand across both FL and DOBCL, bringing Epkinley-based therapies closer to where patients live. And in March, the FDA revised the label for Epkinley and 3rd Line Plus DOBCL to remove the recommendation for 24-hour hospitalization following the first full dose. Now the label advises physicians to assess whether outpatient monitoring or hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting. Beyond the U.S., performance remains strong. In Japan, Epkinlee continues to stand out as the only bispecific approved in both third-line-plus LBCL and FL with continued year-over-year growth. The FL launch is building positively on the brand's success in large B-cell lymphoma, supported by strong field execution and ongoing site activation. In other markets, through our partner AbbVie, AbbKinley continues to grow with approvals in more than 65 countries, which most have dual indications. For the remainder of 2026, we're focused on maximizing our first-mover advantage in second-line FL in the U.S., while preparing for expected approvals in this setting in Europe. and Japan later this year, and in early lines of DLBCL in the future. As we look ahead, our priority is to accelerate development, including in combination and across early lines of therapy, to continue to build on the already strong clinical data demonstrating Epikinley's versatility, and ultimately establish Epikinley as the core therapy in B-cell malignancies. Turning now to TIBDAC, which is the global standard of care in recurrent or metastatic cervical cancer. TIBDAC grew 18% year-over-year, reaching $39 million in sales in the quarter. This reflects both the significant need for therapies that improve survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets. In the U.S., the brand delivered steady performance and continues to lead the market, a position that has held since launch nearly five years ago. Outside the U.S., we're seeing encouraging progress in newer launch markets. In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the U.K., TIBDAC launched in February through private prescribing and payer channels, and we're actively engaging NICE and SMC to secure broader availability. At the same time, building upon our work in the U.K. and our established presence in Germany, we're actively preparing for additional launches, with infrastructure and teams being established across key European markets, including France, Italy, and Spain. Given the significant unmet need in advanced cervical cancer, we look forward to the impact TIBDAC can make for more patients as additional markets gain approval and reimbursement. And more broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact over time, particularly with RENA-S in the future. To wrap up, our Q1 performance positions us well to sustain momentum in 2026. With continued performance and expanding portfolio, we're well-positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including three potential blockbuster assets with F. Kinley, RENA-S, and PETA-Symptomab, and our proven ability to scale commercialization and successfully launch in markets where we can drive the greatest impact for patients. Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for GEMMAP. With that, I'll turn it over to Anthony to walk through the financials.

Thanks, Brad.

Before diving into the numbers, as we highlighted last quarter, please note that these results and guidance in our remarks exclude the impact of acquisition-related expenses, including amortization. A reconciliation to our reported results is included in the appendix. In Q1-2026, we delivered growth driven by sustained revenues and the solid market performance of our portfolio. Revenue grew by 25%, driven by strong royalties from Darzelex and Kesimta. And importantly, this growth was also driven by product sales from our own medicines, especially Epkinly, continuing to diversify our revenue base. Our investments remained fully in line with our capital allocation priorities, including significant investments for Epkinly, Rhena-S, and Pitocentumab. And we made these important investments while growing operating profit by 23%. Moving to tax, as you can see in the appendix of this presentation, we have tax expense of around $21 million, which equates to an effective tax rate of 28.9%. And here, I do want to pause for a moment and note that we are currently evaluating the integration of Merit operations from a tax perspective. So our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12 to 18 months. Overall, the first quarter of 2026 demonstrates the continued strength and quality of GEMMAP's underlying financial performance. With that, let's move to our 2026 financial guidance. We remain on track to achieve our existing financial guidance with revenue growth that enables strategic investment, supporting long-term value creation. At the midpoint, we expect 14% total revenue growth, driven by continued momentum in Epkinly and our royalty portfolio, further enhancing revenue quality. For operating expenses, we expect to be in a range of around $2.7 to $2.9 billion, reflecting planned investments to advance late-stage development for Pitocentumab and RENA-S, as well as launch readiness activities to support multiple potential product launches. And even with this strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026. In summary, our performance in the first quarter of 2026 underscores our ability to deliver revenue growth, advance key pipeline assets, and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2026, we will continue to build on our momentum through disciplined prioritization of our investments, continued operating discipline, and expansion of market opportunities.

This positions us for sustained growth and long-term value creation. and on that note i'm going to hand you back over to jan thank you anthony let's move on on to our final slides in the first quarter of 2026 our financial performance reinforced the strength of our foundation and the durability of a growth trajectory that strength supports a disciplined capital allocation strategy focused on the areas with the greatest potential to create long-term value. Accelerating our late-stage pipeline, maximizing the success of our commercialized medicines, and ensuring strong launch readiness for future opportunities. And as we further move into 2026, we also remain focused on integrating mirrors so that we can capture the full value of pitocentronop. Lastly, we remain committed to deleveraging, targeting gross leverage below three times by the end of 2027 while maintaining balance sheet strength and flexibility taken together genmob is very well positioned we have a growing and increasingly diversified revenue base a powerful late stage pipeline and multiple catalysts ahead and our focus remains clear to translate our antibody science and development expertise into meaningful breakthroughs for patience and sustainable long-term value for shareholders. So that ends our formal presentation. Thank you for listening. Operator, please open the call now for questions.

Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star 1-1 on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star 1-1 again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question. Please, Timbao, we'll compare the Q&A QDs. We'll take a few moments. And now we're going to take our first question. And it comes line of Jonathan Chang from LERINC. Your line is open. Please ask your question.

Hi, guys. Thanks for taking my question. On the frontline pedosemptomab head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes? Thank you.

Thanks, Jonathan, for the question. Thay, why don't you take the first question by Jonathan?

Yeah, thank you, Jan, and thank you, Jonathan. Yes, so indeed, we increased the size of the frontline study. I think we had in the past indicated that there were thoughts that we had as it relates to the studies that we wanted to ensure that they have the highest probability of success. The details, I don't think, are the ones that we want to discuss in a public space. but these trials are being increased based on our insight that we generated during the diligence to ensure that they have the highest probability to our standards. We do not have any anticipation that these changes have any impact on the timelines and steadfast stay with our guidance that one or both of the PETO studies will read out this year and will provide data this year.

Thanks, Tai. Let's move on to the next question.

Yes, of course. Now we're going to take our next question, and it comes line of Zane Abraham from J.P. Morgan. Your line is open. Please ask a question.

Thanks a lot. We've got two questions, Zane Abraham, J.P. Morgan. First question is just a follow-up on the previous one, and it's helpful that you just said you don't expect the increased size of the first-line trial to impact the timing, but just to understand in more detail why that is, given that you're increasing the trial from 500 patients to 700. So have you already completed enrollment of the initial patient population that you're looking to enroll, and how is enrollment progressing, I suppose? And I guess tied to that, whether the increase is for HPV-negative patients, that would be helpful to understand as well. Second question is just on Epkinley first-line DLBCL. You've guided for the readout this year and haven't narrowed out further. So is that the final analysis, or are we still waiting on the interim?

Thanks, Zain, for the questions. I think, Ty, you can handle both of them. We'll start with the next question, and then the APCO first-line trial.

Yeah, Zain, I'm sorry. I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. that this was indeed to ensure that this trial has the appropriate data that we need for our probability of success, how we feel about the program and what we understand about the program, and this will not impact the timelines and what patient populations it does impact or the timing or the status of a call. I hope you will appreciate that in the context of a very competitive landscape, we are trying to be a little bit more disciplined on what we're sharing, when we're sharing it. So two things. It will not change the timelines of what we've guided before, and we continue to stay with the statement that one or both of these studies will read out this year. As it relates to the FUSA-HP cell, again, I think there we have also been very disciplined, and I will try to be continuously disciplined today. We've guided that the FUSA-HP cell will read out this year, and we have not commented on interim or final or any of these questions. But we stay with the statement that the Diffuse HB cell study will have a readout this year.

Thanks, Zarin. Thanks, Zarin. Let's move on.

Thank you. And now we're going to take our next question. And it comes to the line of James Gordon from Barclays. Your line is open. Please ask your question.

James Gordon from Barclays. Thanks for taking the question, or two quick ones. One was re-narest. So there's O1 and O2 coming in H2 this year. So just wanted to confirm, with the two trials reporting so closely together, so a Phase 2 and a Phase 3, will you definitely report them as separate results? And if the Phase 2 is positive, you'll file it and not wait for the Phase 3? Or have you discussed that plan with FDA? Or might they say, well, if they're so close together, let's see both? And the other one was just more generally, but we've seen more data from B7H4 ADCs in gynecological cancers. How do you think that stacks up versus FOLA ADCs? There seems to be a few people going for this approach. It's a different target.

Thanks, James, for the questions. I will ask Judith to address both the Phase 2 and Phase 3 PROC trials, Judith, and then the B7H4 versus folate receptor alpha ADCs.

Yeah, thank you for the question. So for the first part, as we highlighted, the Phase 3 accrued ahead of projections. That means that we will have these two data sets this year. Given the change in landscape in PROC, the potential for the Phase 3 submission and approval becomes more relevant, and this is the plan. So we stay behind our guidance that RINA-S will be launched in PROC in 2027. with these two data sets at supportive, but the main data set for filing the phase three that will allow for global submissions. Part one, with regard to the competitive landscape, of course, we are very aware of the D7H4, the two in investigation, the Glaxo and Prutisam. As we said several times, we know that this is a hyper-competitive space. We stand behind the strength of the data of RINA in terms of efficacy, safety, durability of the efficacy, and a clinical development plan and speed to market. So more competitors makes it more competitive, but doesn't preclude the fact that we could be not just first in class, but best in class, given the data so far.

Thanks. Thanks, Judith.

So it comes down to effective execution, James, and we moved in basically two years from zero phase trees to now five phase trees with the news of today. thank you now we're going to take our next question and the question comes line of shan dang from ubs your line is open please ask your question uh hi uh from ubs thank you for taking my question so i got a few uh at kingley frontline dlbcr trials please um just wondering even you know the typical pss pfs curve tend to pretty much you know almost start to plateau So after, let's say, 18 months or so, in a typical, let's say, frontline DLBCL trial like Polarix, just purely hypothetically, right, doesn't have to be, you know, anything to do with that keenly, just purely from a statistical point of view, do you expect a big change in hazard ratio when, you know, during the last 25% of events, just assuming sort of a typical, let's say, frontline DLBCL trial, you know, PFS curve? that's the first question um and the second one is kind of you know also on that one is um your study is capped at 30 percent of ipi stage 2 patients um so just wondering if you could give any colors on whether you know you've reached this number or um your ipi 2 patients is actually below this and just wondering what uh impact could it have in terms of powering and timing or the primary endpoint. Thank you.

Thank you, Sian. I was always teached never to answer hypothetical questions, but we'll test out whether Tai is willing to do that. Then move into the second part as well. Tai, over to you.

Yes, Sian, thank you. So what I can say is you're absolutely right. Classical historical diffuse large piece are all, by the way, not only Polarix. Frontline studies tend to plateau around month 18 to 20. And I think that's my only comment on that question. I'm particularly speculating what I expect. I don't think it's helpful because I actually don't know how these curves are going to behave on this trial until we see the data. The cap is also correct. There's a 30% cap. Again, I don't think it's appropriate at this point to talk about what the extra demographics of the study are. The only other point that I think is important to understand, the primary endpoint is actually IPI 3 to 5. and if IPI 3 to 5 passes, you know, certain statistics, then it will read out 2 to 5. And so I think these are my comments on their questions.

Thank you. Well, I'd fight.

Thank you.

Yes, absolutely. Thank you. On to the next one, operator.

Yes, of course. And now we're going to take our next question. and the question comes down of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Hi, thanks for taking a question. So first one on Epkinly, just kind of following on the theme there, but what do you think is sort of the relevant benchmark for Epcor DLBCL4? That's a second line trial just in the context of the competitive landscape and some of the potential advantages that EPCINLY has. And then secondly, just on the new RINA-S trial that you announced, Rainfall 08, is that likely to be a K-truda combination trial?

Thanks, Rajan, for the questions. Ty, why don't you take the first one and then maybe Judith can go into the new RINA-S trial, one of the new RINA-S trials.

Yes. So this is a question about the second line, the few such pieces, right? And so I think there's a couple of things to be said about the 1-2-8 study. First, it is, again, a randomization against RGEMOX, so in the end, that's what the study is going to be compared, and everything else is going to be a cross-study comparison. They're obviously a little bit problematic, but what is the excitement on our end for this particular regimen is that this is a regimen comprised of oral medication, analidomide in a subcutaneous administration that hopefully will show positive data and meaningful positive with data for patients, and then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combinations with Jemrox, but also improved in efficacy vis-à-vis monotherapy, and is really perfectly suited for the outpatient setting or the community setting, and that's what this trial was intended to do, to generate a regimen that is patient-friendly with increased CR rate that then is appropriate and suitable for the community setting. And so we'll see what the data is, but that's the intent of the trial.

Thanks, Tai. And then maybe you let on the combination for Rina.

The question, can you repeat the question, the combination with VEV, did you ask? Oh, yeah, the data that we present. Okay, so we, in terms of combination, the combination with VEV was presented at SGO. And as you can appreciate, if you are there, you know the safety was very well tolerated. The study was meant only for safety, but in terms of efficacy, we are very pleased with the median number of cycles of 10. And even the fact that 15 of the patients were refractory, 85% of the patients got more than six cycles. So this is with Bev. In terms of PEMBRO, we have two cohorts ongoing in different settings, and we will communicate the data when the data is a little bit mature and enrolled. So it's actively enrolling.

Thanks, Judith. I think that answers your questions, Rajon. Let's move on to the next question.

Yes, of course. And now we're going to take our next question. and the question comes line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Hey, thanks for taking my questions. I had another one on EPCOR-DLBCL2. Maybe just in terms of the enrollment of the study, Tahi, could you just comment on how enrollment has been relative to your expectations when starting the trial? And secondly, I know in the Phase II study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed-duration treatment in the Phase III study. And can we speak to your confidence level that the fixed-duration paradigm can replicate the Phase II data?

Thanks, Michael.

Yeah, generally speaking, I think true for 1 to 8, which is the second-line diffuse HB-side trials, for the front-line diffuse HB-side trials, that these trials accude significantly faster than they were initially projected. And I think that's a statement that we've made multiple times. as it relates to the original Phase II data in Frontline where we continued epiomal therapy after R-CHARP for the full year and the design of the trial, the Phase III trial, where it's R-CHARP for six cycles plus Epkindi followed by two monotherapy cycles of Epkindi. When we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to, as we generated the data and had the opportunity to see this and also discuss with health authority, it became very clear partially also because of the data that was presented by Fauci on MRD negativity that you don't actually need to expose these patients to continue therapy. Keep in mind, a significant portion of these patients are cured already with our job. And so that's why we ended up with the design. Again, we feel extremely confident that the, if you will, shortened obturation of gap kidney, as you framed it, doesn't have any impact on the ability of this combination regimen to achieve CR and even MID negativity at really very high rates as they have been in the public domain and shared. And we have a reason, as I've discussed many times, to be confident, because we've seen this now in a number of trials at Epkinli, that the phase three trials tend to mimic the original first two data, just because the mechanism is very predictable for Epkinli.

Thank you.

Thanks, Ty. Thanks, Michael.

Thank you. And now we're going to take our next question. And the question comes from Benjamin Jackson from Jefferies. Your line is open. Please ask a question.

Brilliant. Thank you for the question. I guess just another one, thinking about sequencing of drugs through the lines of therapies in DLBCL. We've heard from some docs that perhaps polyby is a very strong salvage option. So when you're speaking to physicians, are you hearing that there is a preference for biospecifics up front, just naturally because of the order that those drugs can come in? So any thoughts that could be a tailwind there would be useful? Thank you.

Thanks, Ben, for the question. Ty, this one is, again, for you.

Well, I think, yeah, I'll try to answer Benjamin, and maybe Brad has to add something. He may add something to do. But from the way I think about this, at least, I think this is also how physicians that we work with and obviously engage, think about this. The sequencing of drugs, generally speaking, is a function of efficacy and safety. And in particular, in diffuse archbicel front line, where R-CHOP cures a decent amount of patients, I think the anticipation just has to be that, you know, the trial that reads out is going to generate data that is going to have a significant impact on the outcomes for patients. And if it does, then that will need a natural adoption because the obvious goal in diffuse archbicel is to avoid the relapse of factory setting where things become, generally speaking, a little bit harder to manage.

Thanks, Ty. Brad, do you want to add anything to this, to sequencing of the medicines?

I think maybe the only thing to add, Ty said it well, is we do hear from physicians that, and we've said quite a while all along, that the value of high specifics are certainly in the earlier lines of therapy where patients are actually treated closer to their home. And we're starting to see this really come to fruition with the advent of the SecondLineFL launch just late last year. And that's been a key growth driver. The feedback from physicians, hospitals, and hospitals, and health systems has been extremely positive with not only the unprecedented data, as I tell you, reference, but also the convenience and being able to realize the value closer to the patient's home.

Thanks. Thanks, Brad. And Ben, we are super excited about the potential to see both the front line and the second line, the fuselage pre-cell lymphoma data, pretty soon for Apkinly or Apkaritomop. So exciting times.

Thank you. Now we're going to take our next question.

And the question comes down from Charlie Haywood from Bank of America. Your line is open. Please ask your question.

Hi, Charlie Haywood, Bank of America. Thanks for taking the question. I have two, please. First is on your PITO Phase 2 OS rates. I just wondered if you've taken a two-year OS cut and any directional comment on how that OS curve has trended relative to the first 12-month data that we've seen. Would it be fair to think a similar trajectory to what you've seen at year one, or could you actually see similar to what your competitor saw with faster first 12-month curve decline and then stabilize more thereafter? And then will that data be presented any time? And then second one is just on RINA-S in second line endometrial. Could you just remind us on timelines of that data and then frame your excitement in that op relative to the more imminent second-line proc setting? I think potential smaller patient number there, but possibly higher unmet need given lack of limited ADC presence to date. Thank you.

Thanks, Charlie, for the questions. Ty, why don't you take the first one on PETO, and then Judith can handle the question on Rina. And then I'm going to cancel second line.

So if I understood your question correctly, you were asking if we are intending to update the phase two data set for PITO in second line or in front line? In front line, yes. In front line. Well, I mean, we'll probably at some point go into an update that curve presented in the data, but I think the more meaning we draw, there's going to be the actual study. So, you know, we said one or two of them will be out this year. And so that is probably the more meaningful data set and relevant to the brand and to the company.

Thanks. Thanks, Tai. And then Judith, maybe there's something more on the timeline for SecondLine plus Endometeo and Rina.

Yeah, no, thank you for the question. And as you know, the phase three is actively enrolling. We haven't guided the investors community about readouts, but what I can say is the activation and enrollment is going very well.

Thanks, Yuda.

Just something to add to Ty's first question on the first line, a PITO-Pembro combination. I think that it's very apparent what we already presented with 17-month follow-up, which is not negligible. And at this time point, around 30% were censored and alive. And this gives you a kind of magnitude of duration. And as Tai alluded, now we are fixated on the phase 3s, which are much more relevant. but i think that the data presented at asco is a very good representation of the durability of the effect thanks thanks thanks charlie for the questions let's move on to the next question yes of course and now we're going to take our next question and it comes to land of ever for tear from wells fargo your line is open please ask your question Hi, team.

Thanks for taking our question. A quick one from us on PITO as it relates to CRC development. How should we be thinking about timing for any announcements for this tumor type, and are you exploring other mechanisms that would make sense to combine with beyond chemo? Thanks.

Thanks, Eva, for the question. I think probably Tai can handle this one, CRC updates for PITO in the second half?

Yeah, so look, we've answered this question a couple of times. We obviously have looked at the CRC data. We have generated more CRC data. We liked what we saw early on in the diligence. We continue to like what we see. And we will update you a little bit closer to, similar to what we did with Rina, to when these studies then go into the public domain on our next steps. So there will be more to come at some point. So as it relates to combination with other mechanisms, there's a number of interesting things that are happening in this space in the subset of patients, and obviously we are aware of that, and there's a good rationale to combine with PETO, and so more to come on that end as well.

Thanks, Tai. So we keep the cards closed to our chest, Eva, because it's a very exciting area and also a very competitive area, so we want to be first and hopefully best here.

Got it. Thank you. Now we're going to take our next question. And the question comes line of Matthew Sipps from William Blair. Your line is open. Please ask your question.

Hello. Thanks for taking my question. I'm going to harp on the fetal symptomat of enrollment as well. You know, there are some rumors on whether or not to increase the 200 patients would focus exclusively on HB negative patients. So, can you just remind us on your thought on the breakdown of patients by that based on characteristic?

And then, has the number of patients needed to conduct the or our analysis changed or is this really just patience for the os analysis thank you thanks matt for the questions ty can you address both of these questions and give some perspective that's all i'm going to ask you to answer answer your questions um a good question um i will not go into the specifics i will stick with the line that i used before um that um you you know, the increase in the end of the study was intended to increase the overall probability of success of the study as we see it based on what we understood in the diligence these were decisions made already back then and that we continue to understand about PITO and that none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

Thanks, Dai. Thanks, Nat, for the questions.

Thank you. And now we're going to take our next question. The next question comes from Yaron Weber from TD Securities. Your line is open. Please ask a question.

Thank you so much. Tai, I'm just going to maybe ask another question, and I'll like your program maybe a little bit broader. Do you plan on filing with both studies, or would you file presumably on second line, potentially first, and then front line? And when you do release the data by year-end, do you think it's going to be – let's assume it's going to be in second line first because you're not continuing to – you're not over-enrolling that study. Would you have kind of, you know, at least the interim OS and would it even be mature OS at that time?

Thanks, Yaron. Zai, that's another sharp one.

Very good question. Unfortunately, my answer will be the same that I did before. So right now, all we guide and have been consistently guiding that we indeed expect one or more of these studies to read out this year. And I will not comment on which one first or second, and together all these permutations that may exist.

Thanks, Zai. Some more to come later, Jarom.

Thank you.

Now we're going to take our next question.

Just give us a moment. And the question comes to the line of Suzanne Van Wurhuizen from Van Lanschot Kampen. Your line is open. Please ask your question.

Hi, team. This is Romy on for Susanna. One on Upkinli, so looking ahead to the phase three readouts in first line. We recently did a survey which found that doctors are projecting Upkinli even before seeing this data to be the most dominant first line option. I just want to know your thoughts on what you see as the most important features of Epkinly specifically that drives this enthusiasm. Thank you.

Thanks very much for referring to that very nice survey. We like the data, of course. And then we'll ask Ty to sum up basically what the key parameters are here for why Epkinly is so advantageous in the first-line setting according to the survey.

Yes, I mean, this is like, you know, if you step back, this is also something that we talked about from the very beginning when we engaged on the development program with Mkindi, that the CD3C20 mechanism of action of Mkindi is a unique and very powerful senior agent mechanism that comes with a safety profile that predominantly is infusion-related reactions and then otherwise is extremely well-tolerated. And because of subcutaneous administration, also a convenience administration that makes it easy for the patient and also for the providers. And so if you start combining Epikinle and CD3, CD20 with chemotherapy, we've already seen this in all kinds of phase two studies or phase three studies. That tends to be a mechanism that is very well combinable with chemotherapy and at least additive. And so that's, I think, what's driving the enthusiasm about frontline in terms of what the expectation is around data. And then what drives kidney specifically, of course, is then the observation that A, in very high likelihood, will be the first study to read out in frontline diffuse archipelial with a significant time advantage. And B, it is the one that comes with a subcutaneous administration. And as Brad was saying earlier, in frontline diffuse archipelial, the vast majority of these patients are actually treated in the community setting. And so the fact that there is now a potential readout on a drug that is available for these physicians and these patients in this particular setting, particularly in the U.S. healthcare system, that is labeled, it's the only one that is labeled, without restrictions on where it can be provided to the patients. I think that is what's driving the entire enthusiasm on that particular study and I think why we had, I don't know, six or seven questions from you guys on this study.

Great, thank you. Thanks, Tai, for the answer. Let's move on to the next question.

Yes, of course. And now we're going to take our next question, and it comes to the line of Victor Flock from BNP Paribas. Your line is open. Please ask your question.

Thanks so much for taking my question. Just one on Epkinli. So, I mean, Epkinli has reported a decent Q1 performance. I was just wondering whether this is driven by the recent label change in the U.S. So, I mean, I was just wondering if you see a material uplift in the academic setting and whether you can comment on the key errors that you need to clear to further drive penetration in this setting. Thank you very much.

Absolutely, Victor. So, good question. So, Brad, you can handle both of these, huh?

Yeah, no, I think, first of all, thanks for the question. and the strong start to the year is certainly evident by the profile being appreciated by physicians as well as health systems, primarily being, you know, looked at as the only bispecific of the dual indication. And the proven efficacy piece is certainly extremely important, as well as the subcutaneous administrations, which is what Talia mentioned well. Now, as it relates to So the moving forward into earlier areas, the ability to, again, have all of these ingredients in place, moving quickly into earlier lines, featuring accommodations as well as fixed dose options is extremely important. But then also, as you mentioned, as it relates to the performance, second-line FL, we're seeing as a key part of this driver performance. And then the hospital removal, the potential hospitalization update has been very well received. And again, looking to remove just additional barriers to be able to treat patients closer to where they live in the ways that you're seeing with this extremely important profile from an efficacy, safety, and deep, durable responses along with subcutaneous administration.

Thank you, Brad. Thanks, Victor, for the question.

Thank you. Now, we're going to take our next question, and the question comes from Kalpit Patel from Wolf Research. Your line is open. Please ask a question.

Yeah, hey, thanks for taking the question. For EPCOR-DLVCL2 trial in frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind Polaric study? And then do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in the first line?

Thanks for the questions. Ty, you can address both of these, huh?

Yes, so this question on what hazard ratio we are expecting has come up a lot. Essentially, it doesn't make sense to speculate. What we've said is that based on the public data that is available in Phase 2 is, of course, and you heard this in the other question earlier, expectation and enthusiasm of what the possible readout of that study. So phase 3s have, in the past, on a kidney, tended to mimic close phase 2 data, as I said, because it's a mechanism of action that's very predictable. And so we're excitedly awaiting the readout and, of course, are very enthusiastic of how positive this trial could be, but we will see what it is when we have it. As it really relates to OS now, we all know from the ODAC that the FDA will approve frontline diffuse arsonistia regimens even without the OS benefit set in the path. The ability of showing an OS benefit, of course, is becoming a little bit more challenging in diffuse arsonistia in general because of the increasing availability of very effective salvage therapies for particularly the worst patients. But in a primary factory, they have access to cards. And the biospecifics that are also now penetrating second line and are already very much available in third line. Having said all of that, it's also a function of the effect size that you have from PFS, meaning the larger the PFS has a ratio benefit becomes, the larger the opportunity to show an OS benefit. That's kind of like broadly speaking how we think about it.

Thanks, Dai. Let's move on to the next question.

Yes, of course. And now we're going to take our last question for today. and it comes line of Judah Fromer from Morgan Stanley. Your line is open. Please ask a question.

Thanks for squeezing us in here. Just a follow-up on the PETO trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial? Will you be adding any investigation sites? I'm just curious if you are, if any other EGFR bispecifics might be being studied at those sites and what reception might be.

Thanks, Judah, for the question. Tai, can you address the recruitment and the setting for the PITO trial?

Yes. What I will answer, Judah, is that this amendment that increases the ADN had no impact on additional sites or a need for any additional sites. The study is enrolling extremely well, so that's why it won't have an impact on anything.

Thanks, Tai. And that, I think, addresses the last question of today. So thank you all for calling in today. And if you have any additional questions, please reach out to the investor relations team of Genmob. We very much look forward to speaking with all of you soon in this super exciting year for the company.