Genmab A/S

Hello and welcome to the GENMAP first half 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, and many more. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure. 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 Winkel. Please go ahead.

Hello, everyone, and welcome to our financial results call for the first half of 2026. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahy Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As the operator said, we will be making forward-looking statements, so please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do, accelerate our late-stage pipeline, maximize our commercialized medicines, and stay disciplined with our capital. And that is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio. even as we have made focused and strategic investments in our late-stage programs, in launch readiness, and in the integration of mirrors. And we did all this while growing operating profits. To me, that says a lot about the quality of our business. And beyond financial performance, I'm enthusiastic about our recent pipeline progress, so let me walk you through the highlights. In June, we announced positive top-line results from the Phase III APCOR DL-BCL4 trial, which shows statistically significant, clinically meaningful improvement in progression-free survival. What is important about these results is what they demonstrate about the apcaritumab more broadly. It is growing evidence of the versatility of apcaritumab-based combinations across multiple lines of therapy. This data was followed by the European approval of tepkinli plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second-line setting. This makes tepkinli the first and only bispecific-based therapy approved in Europe for this indication. Our presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. and we are looking forward to sharing with you p2-centimab data with updated results in colorectal cancer presented at ASMO in October. Based on this promising data, we are continuing to build momentum for p2-centimab. We are initiating two new phase three studies in colorectal cancer and Thij will share more detail on them in just a moment. Now let's turn to the catalysts we continue to look forward to this year on the next slides. As we move into the second half of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts. For RINA-S, we anticipate both Phase II and Phase III platinum-resistant ovarian cancer datasets will be available in the fourth quarter. For Pitocentumab, we are eagerly awaiting the readouts for both studies. and with better visibility, we can now say that the front line study is expected to read out in the fourth quarter, while the second and third line study is anticipated to read out in the first quarter of 2027. Finally, for APKinley, we anticipate that top line data from the front line APCOR DLBCL2 study, which will be based on an interim analysis, will also be available in the fourth quarter. What this means is that for each of our late stage programs, we remain on track for phase three readouts in the second half and then potential approvals and launches in 2027. This is what we have been building towards and it reflects our focused execution. So, exciting times ahead. Now I would like to hand you over to Tai to walk you through the details of the phase three colorectal studies. Tai, the floor is yours.

Thank you, Jan. We are pleased to share our plans for pitoacetamab in colorectal cancer, which build on our ongoing phase three trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. And as you know, PETO is a EGFR-LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. And LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RAS, RAF, wild-type colorectal cancer. And the early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October. Based on this promising data, we are initiating two phase three studies, one in frontline and one in second line colorectal cancer. For frontline, we have already initiated a phase three, randomized trial, open label, a global trial that is designed to assess the efficacy and safety of pitoxetamab plus investigator choice chemotherapy of either mFolfox6 or Folfuri. A first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer, that is RAS, RAF, wild-type. It will thus be versus the standard of care, namely Cytuximab plus chemotherapy. For the second-line colorectal cancer patients, the Phase III trial will be similarly a randomized open-label and global trial. This trial is designed to assess the efficacy and safety of pitocinamide plus investigator choice therapy of either modified Folfax 6 or Forfiri. The second line therapy in patients with unresectable metastatic colorectal cancer that are RAS, RAF, wild type. And here, the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy. So taken together with our two ongoing phase three trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer, and the encouraging data we continue to generate Pituzentamab is a rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients. And with that, I'm pleased to hand over to Brad for a review of the recent commercial performance for AppKinley and Tifda.

Thanks, Thay. Our proprietary portfolio performed incredibly well in the first half of the year. Sales totaled $396 million, representing 37% growth compared to the same time last year. These results demonstrate the strength of antibody sciences as well as the strong execution by our teams to bring our medicines to patients around the world. The performance we delivered in the first half of 2026 reflects a growth for both Epkinley and TIBDAC globally. We're very pleased with how Epkinley is performing. In fact, Epkinley grew to $312 million in sales for the first half of the year, representing a 48% increase year over year and a 28% increase in the quarter. In the U.S., we delivered accelerated growth with increases in both new patient starts and new site activations. The launch of chemo-free, fixed-duration Epkinley plus R-squared and second-line FL has been going extremely well with rapid uptake across sites. This contributed positively to our growth in the first half of the year and suggested Epkinley is becoming a preferred regimen in this setting. We've also seen increasing growth in the community this year, with the majority of new sites activated coming from community practices, and now over 90% of our key customers are ordering for two or more sites. This is driven by Epkinley's differentiated dual indication label, without a recommendation for 24-hour hospitalization, and broad adoption of Epkinley Plus R Squared and Second Line FL, which is leading more sites to utilize Epkinley across its approved indication. This performance reflects strong execution by our field teams, physician confidence in Epkinley's differentiated clinical profile, and the value of using a single bispecific option across DLBCL and FL. The uptake we're seeing in the community with more physicians gaining experience using Epkinley at sites of care closer to where patients live is a positive indicator as we look ahead to potential launches in early lines of DLBCL. Outside the U.S., performance remains strong. In Japan, Epkinley continues to build on its compelling position in the market with approvals in both DLBCL and FL. We expect the second line FL launch, anticipated later this year, will serve as another growth driver for the brand. Through our partner, AbbVie, Epkinley's global footprint continues to expand, including recent approvals for Epkinley plus R-squared and second line FL in Europe and China. Overall, we're really pleased with Epkinley's growth globally and particularly in the U.S. and Japan where we book sales. The momentum we are seeing today reinforces our confidence in Epkinley's long-term growth opportunities, especially its potential in early lines of therapy. As we look towards the back half of 2026, we're focused on continuing to grow Epkinley and strengthening our leadership in the market by maximizing our first mover advantage in second line FL, and preparing for anticipated launches and early lines of DLBCL in the future. Turning briefly to TIBDAC, TIBDAC totaled $84 million in sales during the first half of the year, driven by continued performance in the U.S. as well as in our launch markets in Japan and Europe. In markets where TIBDAC is available, we saw expanding site activations underscoring the continued need for treatments that can improve survival for women with advanced cervical cancer. As part of our work to bring TIBDAC to more patients, we secured reimbursement for TIBDAC in the UK, and the conversations continue to progress in additional markets. Looking ahead, we remain focused on continuing to scale our commercialization capabilities to support TIBDAC launches in new markets, while building on that foundation to prepare for the anticipated launches of RHNA-S and Pitocinzumab in the future. Heading into the second half of 2026, we're extremely pleased with the performance across our portfolio. Our performance to date combined with meaningful momentum underway across the business to advance our pipeline and expand our commercialization footprint positions us well to grow adoption of our approved medicines to benefit more patients and successfully launch additional indications and new medicines as we look towards the end of 2026 and into 2027 and beyond. With that, I'll turn it over to Anthony to walk us through the financials.

Thanks, Brad. The first half of 2026 demonstrated the continued strength of our business, with revenue growing 25% year over year. Beyond the headline 25% revenue growth, I'd highlight two characteristics of our performance. First, high growth, and second, broad-based growth. Now, starting with the high growth, Darzalex increased 21% year over year. while worldwide at Kiddly net product sales increased 48%, reflecting continued commercial momentum and strong execution. Beyond these two brands, the remainder of our portfolio increased 35% year over year. Now turning to broad-based growth. Approximately half of our year over year revenue growth came from Darzalex. Impressively, the other half was generated by Ed Kinley and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base. The strength of our business also provides the financial flexibility to continue investing behind our highest value growth opportunities, including Epp Kinley, Rena S, and Pedocentimab. At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that GemMap can increase investment while continuing to expand profitability. Before moving to our updated 2026 guidance, let me briefly comment on tax. Our effective tax rate for the first half was 3.6%, primarily reflecting the ongoing integration of merits and related recognition and utilization of deferred tax assets. As shown in the appendix to the presentation, this equates to tax expense of $13 million. Now, as we discussed previously, we continue to evaluate the integration of MARIS from a tax perspective. As a result, our effective tax rate may continue to fluctuate as those integration activities progress. We expect our effective tax rate will normalize over the next 12 to 18 months. Now, with that, let me turn to our updated 2026 financial guidance. The strength of our business and the financial flexibility it continues to create are reflected in our updated 2026 financial guidance. Compared with our previous guidance, we now expect to deliver 5% higher revenue and 7% higher operating profit, while increasing investment by only 2%. This demonstrates the operating leverage inherent in our business. Starting with revenue, we now expect full-year revenue to be in the range of $4.3 to $4.5 billion, representing 19% year-over-year growth at the midpoint. And this compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both Darzelex and Epkinley. with the $195 million increase at the midpoint being approximately equally split between Darzalex and Epkinley. Now turning to operating expenses. We are continuing to invest behind our highest value growth opportunities. Our updated operating expense guidance includes additional investment to maximize the long-term value of our portfolio, including the two new phase three pitocentumab studies

we announced today.

Even with these incremental investments, we're only increasing our OpEx guidance by 2%, resulting in a new midpoint of $2.88 billion. Finally, operating profit is now expected to be in the range of 1.1 to 1.4 billion. Importantly, the majority of our revenue outperformance continues to translate into higher operating profit while preserving our ability to invest behind our highest value growth opportunities. In summary, our first half performance provides further evidence of the strength of our business. We are delivering high growth, broadening our revenue base, investing behind our highest value opportunities and continuing to expand profitability. Together, this positions us well to deliver sustained growth and long-term value creation. And on that note, I'm gonna hand you back over to Jan.

Thank you, Anthony. Let's now move to our final slides. Looking at the first half overall, we've had a strong six months, both scientifically and financially. and our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long-term value. So when I look at where we are, the revenue base we have built, our versatile and promising product pipeline, and what is still to come in the coming months, I'm super excited. That now ends our formal presentation and thank you for listening. And operator, please open the call for questions.

Thank you so much, dear participants. As a reminder, if you wish to ask a question, please press star, one, one, on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star, one and one again. Please stand by, we'll compile the Q&A roster. This will take a few moments. And now we're going to take our first question. And it comes from the line of Zain Abraham.

Hello.

Your line is open, please ask your question.

Hi everyone, thanks for taking the questions. First question is on the petrosensimab second line trial which we are now guiding for the readout in Q1 of 2027. Just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint cerebral survival or is it the upsizing of the trial and how is recruitment progressing for the second line trial relative to to your expectations. I think the slide suggests it's still recruiting, so just any updates there would be helpful. And then my second question is on Abcord ELB-CL4. It's quite a strong PFS outcome, but just any sense of what you've seen so far on overall survival, or was it just too immature to see a trend at this point? And what's the latest feedback you've had from the FDA on whether the second-line trial or the first-line trial could be used as a confirmatory trial?

Thank you, Dan, for the questions. And I think I will hand them both over to Thay. Maybe start, Thay, with the second line trial for PETO and head and neck cancer, and then move on to DLPCL4 to address some of the points raised here.

Yeah, thank you for the question. And so let's take the PETO first. As you correctly noted, the endpoint is over survival. So this is an event-driven projection from where we have the data and the trial is fully enrolled. So that was to that question. And so we're just updating based on what we see when we expect to have the top line results, which is now in the first quarter of next year. As it relates to the second line, third line, Lin-EPCO combination, you noted correctly that this is a very exciting PFS benefit for patients for what is a chemo-free regimen of a pill with a subcutaneous injection. with a really impressive CR rate for patients. That's the most meaningful kind of data point, and we are really excited about the data. The OS, of course, at that point is totally immature, which is why it's not yet been reported, and the data will be presented in upcoming conference, so we'll have a chance to look at it in a little bit more granular detail. As it relates to the part of your question for the confirmation of the indication that it's already approved, We are, of course, in very active engagement with the agency on all kinds of fronts. And so whether the frontline or the second trial is going to be the confirmatory trial, I think that's an ongoing discussion right now to the degree also depends on how the results of the frontline trial are going to be. And so this is all there is to say at this point. We have an active process, active engagement, and it'll be one of the two.

Thanks, Tai. Let's hand the question back to the operator and then see whether there's another one.

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

Hey, thanks for taking my questions. I had one on EPCOR DLBCL2. I'm just trying to wrap my head around the timing of the interim analysis in the fourth quarter this year. Based on our work, we think this should have already occurred at some point last year. How do you explain this one-year delay, essentially, of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

Thanks, Michael, for the question. Ty, can you address this one?

Well, let's start first. We're very excited about the results of this trial, as we're going to read out next quarter. This is the most important study, I think it's fair to say, within the EBCO Ritamab franchise. There's exciting Phase 2 data that is in the public domain. Last year and the year before presented the ash around the combination of EBCO with ARCHOP that showed really unpercentage CR rates. which is driving the excitement for the results of this trial. And so the only other thing to say is that we have been now confirming that this is based on the interim and that it will be top-lined next quarter. And I think we should probably leave it at this point. And once we have the data in our hands, we can have a good conversation about all of these other questions that may arise. But for now, next quarter, looking forward to it.

Thanks, Thij. Thanks, Michael, for the question.

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

Hello. James Gordon from Barclays. A question and a couple of clarifications, please. One question was on PETA. So the first line trial is now going to report before the refractory trial, presumably because the first line has an OR primary with interim OS, whereas the refractory trial is more mature OS. So for the first line trial that I think we're going to get in Q4, how mature will the interim OS be when you report it that you plan to file? And do you think the first line or refractory is a higher bar in terms of being successful? And then it was just two clarifications. One was for Epkinley and where we're going to get the interim in the first line trial in Q4. So if it doesn't work at interim, will you tell us that and say that the trial is going to continue on to the final data, or it's just we won't hear anything If we don't hear anything by the end of the year, we'll have to assume that it didn't work interim. How that works, please. And the other clarification was just for RHNA-S and PROC, so there's the O1 and O2 trials, they're both in Q4, so phase two and a phase three. Are we going to get two different readouts or will you just, it's the phase three that's material because that's what you're filing, so we'll just get all the data together?

Thanks, Jane, for the questions and the clarification requests. So the first two I'm going to hand over again to Tai, and then Judith can deal with the phase two and phase three data for PROC for RHNA. But Tai, why don't you start with PETO and the frontline trial?

So it was actually, I think, like, I don't know. I stopped counting at three, but OK, I'll try to address all of the points that were made and ask. So the first thing is on the PETO trial, we've In the beginning, stuck to the guidance that had come from me, I was one or both going to read out this year. Now we are being more precise that we actually will have the top-line results on the front-line indication, which is very exciting because this is obviously the one indication that has a significantly larger impact on patients, larger population, and we believe this is going to be very exciting data when we have it to present and discuss as it relates to what We'll be meeting statistical significance. We don't have any visibility to this, so this would be all speculation. So I don't think this makes any sense. So we'll have that discussion when we have the interim results in our hands. But what we are saying is we will have an interim data that we expect to be the basis for filing in the next quarter on this front line PITOTRA. Then I think you asked about whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this to be honest. I think having an OS benefit is always a high bar and then we have a very high confidence in PETO being able to provide an over survival benefit for patients in frontline and in second line This is underwritten to a degree by these two BTD indications in the data sets in the public domain and then it's of course also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients in head and neck in these two studies that are already operationalized in colorectal where we are today announcing that we're going to start two phase threes and then running future trials. It's a very exciting drug. We're really looking forward to the data in frontline and then we can have a more detailed discussion on what actually the data will be.

And then there was a question, Tai, on abcaritamab in the frontline study when we wouldn't hit the interim, what would happen then with the trial?

I think we should stick with what we just said, what we expect to present the interim data next quarter.

All right, very good. Let's stay with that. And then, Judith, maybe the phase two and phase three data sets for Rina and Prok, a bit more color there. Judith, are you there?

If she's unmuted, I can take that too.

OK, why don't you take a tie?

So there will be indeed, as you said, there's a phase two in Prok, and then We already talked about that there's also a phase three. Both of these data sets, of course, will be made available at the time that we get them and then have the top line results.

I think that should do it for now. Thanks. Thank you. Thanks, James.

Thank you.

Now we're going to take our next question.

and the question comes from the line of Gregory Renza from Truist. Your line is open, please ask.

Hi, thanks so much for taking our question. This is for Greg.

I have one for Peter in head and neck. With competitors advancing quickly in the second line, third line setting ahead of your action to read out in the first quarter of next year, what efficacy and durability profile would Peter need to show to remain competitive? Thanks so much.

Thanks, Craig, for the question. Thij, can you take this one?

Sure. I think you're alluding to the J&J filing. I think like, you know, one thing to say is that we just had a conversation about this and that the second line data set will be a phase three with an over survival benefit. And that is a, of course, completely significantly different data set or duration of response data set that may form the basis of accelerated approval. as it is for Amirantamab. So we remain very steadfast in our statement that we believe PETO is the best in class second generation EGFR by specific based on all the data that we have seen in head and neck, but also outside of head and neck. And the totality of our data, the fact that we will have a frontline indication with PEMBO that we are seeking with the phase three readout next quarter, and then a over survival Phase 3 readout in the first quarter of next year. I think this is a very compelling and comprehensive data set across these two studies, monotherapy second and third line, combination with PEMRO frontline that is going to really underwrite our ambition and head and neck. And so we're very comfortable with our position and where we are. and the expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Thank you, Tai. Thanks, Greg. Let's move on to the next one.

Thank you. And to the next question comes the line of Xian Deng from UBS. Your line is open. Please ask your question.

Hi. Thank you for taking my question. I guess I'll just try my luck a little bit on the Eppingley frontline trial. So given the interim still has not passed, this really suggests the events are happening, you know, really, really a lot slower than expected. So just wondering, is there any reason that you could think of that, you know, you can suspect that they are top arms? would perform, your R-TOP arm would perform differently from, you know, the one from Montjuïc phase III trial or the Polyvac phase III trial, at least in the IPI 3-5 group. That's the first question. And the second one, just wondering for PETL in frontline. So your trial design is, you know, chemo-free, so it's with PEMBRO combo only, whereas Revivan is plus PEMBRO plus chemo. So just wondering, and if you could elaborate a bit of rationale in that trial design to go without chemo, please. Thank you.

Thanks, Sion. I think I'm going to pass them over again to you, Tai.

Thank you. So on the front line, I think first things first, I think it's best if we just stick to a few things. First, we are very excited and really much looking forward to this trial based on everything we know about how Epclinic has behaved in the past and how And so there's a lot of anticipation that we have, and I assure you too, for that trial, and there's a lot of excitement about the results that are going to be then reported next quarter. As it relates to the performance of RCHOP, I mean, we have no visibility to how RCHOP has behaved on that trial. We will find out when we get the data. I think it's probably fair to say that RCHOP in the past, as you pointed out yourself, has had a very robust performance, kind of behaves the way RCHOP behaves across multiple trials. But generally speaking, cross-trial comparisons on the control arm are always a little bit flawed because they are informed by regions and patients and all of these things. So we don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP. On the front line, the question was what the reason was for the combination of PEMBO and a lot of these discussions happened a long time ago when this was still in the hands of males. But I think generally speaking, head and neck patients are known to be a fragile population The locality of the disease, the status of the patient play a significant role in the tolerability of the treatment. And even today, if you look at the paradigm, there are patients who get treated with PEMBO chemo and there are patients who get treated only with PEMBO. That is not only a decision made by the CPS score, but it's probably even larger informed by the patient that sits in front of the physician and their status. The data that is out there in the phase two for the combination of pembopetadol is like dramatically different. It's like twice a high response rate and durability than has been described even for chemotherapy pembo. So in that regard, our anticipation is that petopembo is going to provide a truly very significant and important data set for patients with head and neck because it will have, hopefully, if it replicates the data in phase two, a very significant ORR and the duration of response improvement even over chemotherapy combinations with roughly range in the 30% range of response. And then, you know, we'll have a conversation about the comparison to what the J&J strategy may or may not be when we have the data in our hands.

Thanks, Tai. I think very clear. Thank you. Thanks, Sian, for the questions. Let's move on to the next one.

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

Hi. Thanks for taking my questions. Firstly, just on Kinley and just on that first-line trial again. So maybe could you just help us understand, was the data that you saw in the second-line trial better than you were actually expecting internally? And I'm just wondering if, maybe I'm stretching here, but is that giving you increased confidence that the front-line trial could read out at the interim? And then could you maybe just discuss your latest perspectives on the endometrial cancer treatment landscape? Merck have said that they've hit PFS and OS from the interim of their TROP2 ADC trial. Does that, in your mind, when the data come, will that set a bar for renaress? And could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and photoreceptor alpha in endometrial? Thank you.

Thanks Rajan for the questions. So before Tai starts, I think for the frontline study, I can tell you we are super excited based on the phase two studies and the data released last year at ASH, the year before at ASH, Rajan. So we believe that this data will be very, very good in the frontline setting. And of course, the second line data was also fantastic data, but it's unrelated. I feel to the frontline data, because it's in a different setting with different patients with different levels of illness. But I think we are excited about both settings, but the frontline setting, I think the enthusiasm comes from rapid recruitment, and also running against the gold standard. I mean, our job has been for over 20 years, the gold standard in diffused lymphoma. The phase two data actually show if that would translate to phase three, this will be sensational data. And let's hope for good data in the fourth quarter. Thijs, do you want to add anything to that? And then maybe Judith can go into the landscape for endometrial cancer.

Yeah, sure. The only thing I would add is like, you know, I tried to make that point earlier. I think Jan touched on that. The LEN-EPCO phase three actually reported out the way we were anticipating and hoping. And this is kind of like a pattern that we've seen. The efficacy and safety of Eptinly is very predictable. And so we have seen multiple times that phase two combination data approximate very closely to what then the phase three describes in the larger data set. And this is also just to underscore the point that Jan was making. One of the reasons why we are continuously excited, looking forward to that data next quarter in the front line, and then Judith can talk about the emerging, never changing, never stopping landscape in the midfield anywhere else.

Thanks, Tai. Judith, are you back online? Apparently not, so maybe you can dive a bit into the animation landscape.

Then I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a topo ADC with a top two target. And that has really very little bearing on our strategy because I think from the very beginning we were aware that this was going to read out before the data sets for ARENA are going to be available. We continue to be very excited about RINA, not only in PROC, where we already got it, we're going to have some data this year, but also in endometrial folate receptor alpha is expressed maybe on a lower level than in PROC, but it is expressed. And one of the things that we have routinely and repeatedly described with RINA is this phenomenon of efficacy across the spectrum of folate receptor alpha expression. So endometria is an exciting second indication. We initiated two phase threes in that indication. And so we will look very much forward to have that discussion when we have the data. And I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Absolutely. And we have a breakthrough therapy designation, of course, in one of the settings in endometrial cancer. It's super important. 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 from the land of Eva Forte. Your line is open. Please ask your question. Eva Forte Hi, team.

Thanks for taking our question. On CRC, as the landscape becomes increasingly crowded with EGFR by specific, how is your newly disclosed strategy differentiated? and if I might just sneak in a follow-up. Given the growing focus on RAS-directed therapies in CRC, would a combination strategy with pitocinthamab be a viable approach? And what's your current thinking on a potential development path for such a combination? Thanks so much.

Thanks, Eva, for the questions. And we like those questions because we are super excited about the potential differentiation of pitocinthamab. But I will ask Tai to give you a bit more color on why we are so excited. We will present more data from the Phase II setting and Colorectal Gansel. And then also the combinations is also an area we are pursuing. Thij, why don't you give a bit more color to Eva?

Yes, please. Thank you. So first things first, I think Colorectal as this new indication that we are embarking on with PETO, if you recall, even when we start to talk about publicly the There was already a lot of questions about colorectals. There was a relatively small dataset that had been shared, but that numerically showed very impressive ORR data. And of course, this dataset has grown with numbers of patients and durability, and Jan already pointed out that we will share that. And so our enthusiasm has continuously remained very high. for what we see in this dataset and underscores our conviction that PETO is not only the, really in every dataset, colorectal, head and neck monotherapy combination, continuously to show that on point estimates and cross-study comparisons are difficult, it appears to have higher response rate and a better safety profile than, for example, amibantamab. And so this is what underscores the conviction that we really, with PETO, have the best-in-class are all second-generation EGFRY-specific, and that will also translate into meaningful datasets in the Phase III settings for both frontline and second-line colorectal, which is why we started these two trials now, even though, as you kind of alluded to, J&J already has started these trials. So that's the colorectal part. And the Ras field, of course, is super exciting. I worked on Ras inhibitor 12 years ago when it didn't work. And so it's a super fascinating field to watch, and so we are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal. And we are actively engaging in discussions to really embark on these novel combinations. And there will be more to come in the near future.

Thanks, Tai. So thank you, Eva, again, for pointing out this super exciting area. And more to come this year, in the coming months. Let's move to the next question.

Yes, of course. Now we're going to take our next question. and the question comes from Suzanne van Huizen from One Last Shot Campaign. Your line is open. Please ask your question.

Hi, this is Suzanne. Thanks for taking my questions. Also on PITO, which are competitor or partner J&J going for accelerated approval at Amphan's Mab and Heddenhek. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with PITO at this point in time. Could you comment on that? And secondly, You mentioned a couple of times the high confidence in the best in class profile for PETO compared to AMI. Could you elaborate on what is underpinning that confidence, the high response, better safety in the data sets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action? Thank you.

Susan, thank you very much for these questions. I'm going to hand them over in a sec to Tai, but I can tell you that you will definitely have to wait for the ESMO dataset for the phase two data, which will give you a bit of further color, why we are so enthusiastic. And as it relates to the strategy, We think that we will have a differentiated look, actually, based on everything we know. But I'll pause here and let Thijs give you a bit more color, Suzanne, on the head and neck setting and front line, second line, accelerated approval versus potentially approval based on phase three.

Yeah, thank you. And I'm going to reiterate what I tried to point out earlier. I think if we step back on head and neck, where we are is we're going to have a top line result in front line in next quarter this year, and then AOS readout for the monotherapy in the first quarter of next year. I think this is a completely different, in terms of comprehensiveness, but also we're capturing patient population profile than the accelerated profile now that J&J is pursuing with army runtime overhead neck. So we feel very comfortable, particularly because the larger population is in front line about our position where we are, and of course doing everything to accelerate these findings and these launches to the degree that is possible. So nothing changed on our end. We always knew. We have obviously there's some partnership and we want to have some visibility to their plans. And so this is exciting for patients, more opportunities. but we are very confident in our head and neck strategy and there will also be additional studies that we already announced are going to be initiated in the very near future and may just not be public to discuss because I think we changed a little bit our strategy some time ago, similar to the colorectal trials to publicly announce these trials more closer to when the first patient is dosed. And then your second question was around what again sorry,

Best-in-class criteria, why do we say that?

Why do we say this? Yeah, why do we say this? So cross-study comparisons are difficult. But if you just cross-compare monotherapy and second-line head and neck, the small data set that were presented in combination with PEMBO and Frontline for both drugs, the colorectal combination with chemotherapy data sets that exist for both drugs, in all four of these data sets actually beta outperforms Amirantamab on the efficacy. And then in totality, it does have a differentiated safety profile. It doesn't have the same challenges to the degree at least with skin-related toxicities. I think it's a little bit speculative to figure out why that is, but they're clearly different antibodies with different secondary arms. and it's not unreasonable to speculate that the difference in the second arm may have a biological mechanistic role that differentiates both on efficacy and safety. But as is, and I think there's now a larger data set, I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety. This is where we come with this conviction that we have a best-in-class asset in our hand.

Thank you, Tai. Thanks, Susanne, for the questions. Let's move on.

Thank you. Now we're going to take our next question. And now we're taking the question from Charlie Heywood from Bank of America. Your line is open. Please ask your question.

Hey, Charlie Heywood, Bank of America. Thanks for taking the questions. I have two, please. So this one is just, or both actually, I'm really rare. The second line PROC data we've got coming in fourth quarter. So both phase two, phase three is in fourth quarter. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts, anything to consider as we sort of read across between the two? And secondly, we've seen limited phase two PFS data for the phallic receptor class in general. So could you frame any target PFS profile or PFS delta versus control alarm you'd expect to see to be clinically meaningful for that phase three readout? Thank you.

Thanks, Charlie, for the questions. Ty, can you address both of them? Differences between the phase two and phase three, and then the profile as it relates to expression levels.

Yeah. By inclusion-exclusion criteria, they're really much more or less the same patient population. So there is a readout for sure based on the Phase II data to the Phase III data. And then the only difference is, of course, a Phase II data set has always its own dynamics vis-à-vis a Phase III trial. And then there's always a larger footprint for a Phase III trial as it relates to a Phase II trial. where the patients come on and the difference between having a choice or being forced to have a choice versus not having a choice. And so that's kind of the difference between these two data sets, probably all to say to that. As it relates to speculating on the RENA, I don't think I want to do that. All I can say is that we are super excited about this data that if you look at what is already in the public domain for RENA-S, It shows a very high response rate, 50% plus 50, which is probably even more important, a very long durability of response. And this duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AE, so it then allows a long continuation of treatment, which then drives the duration of response. And if you put these things together, you can already get a sense of the direction of the PFS, which I think will be, without a doubt, not only significant, but also meaningful for patients. I think that's where we should leave it, that we can have this conversation when the data is in the public domain.

Thanks, Thijs. And on top of that, Charlie, you will get that we are like a year, one and a half years ahead of some of the potential competitors. So I think we're in good shape here.

Thank you.

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

Yes, of course. Now we're going to take our next question. And the question comes from Yaron Weber from TD Securities. Your line is open. Please ask your question.

Great. Thank you so much. Quick question on PDO. For the first line study, can you just give us a sense when you upsize the study, can you confirm that you didn't change the powering assumption? and that you're enrolling the random distribution of HPV negatives and positives that are in the market. You're not enriching specifically for only one subtype. And then secondly, you're going to show us the second line recurrent head and neck data at ESMO with or without PEMBRO. Is there a chance that you might want to move to phase three in that study with PEMBRO to complement your monotherapy second line data which is coming Q1 next year? Thank you.

Thanks, Jaron. Ty, can you address both of the questions?

So let's take the first one first. I think we said multiple times we changed this trial to increase the probability of success. And this was not in any particular shape or form driven by anything that really emerged after the acquisition. This was actually a decision that we at Gemmab had made. during the diligence process and that got executed immediately. It was one of the first things that we actually executed. This was purely driven to ensure that we have the proper power for all kinds of subgroup analyses that are going to be important for global findings. So I think that's all there is to say about this. The rest is not necessarily part of our thought process or anything that we have spoken about. And then the second question that you had was around other strategies for PETO. And I would say this. We've been very clear. There's going to be more to come on PETO in head and neck. And we will present these trials in the granularity and at a time similar to what we just did with colorectal when they are literally dosing patients. and that is so in some near future we will have more conversation with more activities about trials in head and neck if that's fair.

Thanks Tai. I think that's clear. Thanks Jeroen for the questions. Let's see whether there are further questions.

Yes of course. Now we're going to take our next question. And the question comes from Benjamin Jackson. Your line is open. Please ask the question.

Brilliant. Thank you for the question. I've got two, please. The first one on renaress. Look, we've seen a couple of other companies make moves into drugs that look to overcome top-01 resistance. So, look, the aim for renaress is to come first to the market, but are there any implications to this and thinking, you know, positively or negatively, how this resistance could emerge for when thinking about the renaress commercial opportunity once the competition comes to market? and then secondly look not a focus topic today lots of other stuff going on but obviously any updated thoughts on the epkinley potential in INI diseases where B-cell pathology is key there's obviously a few competitors making noises in this area with similar drugs so be interesting to hear your thoughts there thank you

Thanks, Ben, for the question. So with RHNA, we of course hope to be first to the market, and we are going to read out already a phase three in Q4. But Thij, do you want to comment on top of one resistance and strategy for RHNA?

Well, I mean, you said the first one. The most important part is there are already three phase threes actively involving patients in ovarian cancer, one in Park and two in Pisac. on maintenance, one on the platinum replacement strategy. And so we are constantly and actively working on moving essentially the entry point for Wiener into earlier lines. And we have already talked about that there's more to come also in the ovarian cancer space with Wiener. And that's basically the reality. You have to like develop these drugs and then just try to move into earlier lines as efficiently and as effectively as data allows and operation allows. That's the first, partly also the only thing to say about this emerging idea of topo resistance, because if vena, which we have very confidence will be the first topo payload ADC in Prague, then this is more a post-vena problem, to be honest.

Exactly, and then INI and abcaritum, right now the focus plan is on cancer, multiple cancers, and we will have Exciting data read out in Q4. And then let's discuss INI in more detail in the future. But cancer is clearly the priority for us right now. Operator, can we move to the next question?

Yes, of course. And now we're going to take our next question. And the question comes from Judith from Morgan Stanley. Your line is open. Please ask a question.

Yeah, hi, thanks for taking the question. Maybe just a follow-up on PDO and Frontline. Can you help us with thoughts on the nature of the update in Q4? So it'll be a top line, but can you give us any direction on whether you'll kind of press release in line with some of the top lines we've seen for EPP Kinley, or could we potentially see subgroup data perhaps by HPV status? And if not, do you have a sense for when we would see responses by HPV negative versus positive patients. Thanks.

Thanks, Judah. Thij, can you give a bit of color on the top line results that we intend to present in the Q4 timeframe?

Well, so I think the accurate response to that question is top line results in general have historically focused on the primary endpoint. and I think that's what's going to be happening for PETRO as well. And then obviously once we have the top line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data in a public presentation at a conference.

Thanks. Thanks, Tai. I think we keep it to that, Judith, at this time.

Thank you. Now we're going to take another question. And now we're going to, the question comes from Victor Floch from BNP Paribas. Your line is open, please ask your question.

Hi, thanks so much for taking my questions. Actually, two questions on Ed Kingley. First one, very impressive momentum lately. And I mean, obviously, you've mentioned the accelerated uptake in the community setting. So just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling Remaining of the Year for Ed Kinley. And my second question, still on Ed Kinley but on IP. There is a report from Bloomberg arguing that Ed Kinley's formulation, Patent 70, could extend beyond the composition of matter patents and could potentially add like five years' protection in the US, six years in Europe. So just wondering whether you can discuss your IP strategy and your current assumption for Ed Kinley in terms of IP. Thanks so much.

Thanks, Victor, for the questions. The first one can be handled by Brad. And the second one, I think I will ask Ty to give some color on the length of time for the patents. Brad, why don't you start on the stocking question?

Yeah, no, thank you for the question. And just briefly on the community, we are encouraged, as you mentioned, with the momentum there. And it's due to the dual indications, the only bispecific with the dual indications. And it's really been perceived extremely well physicians as well as health systems, but there's a link specifically to stocking, no stocking issue or no stocking at this point in time to be discussed.

Thanks, Brad. And Ty, do you want to add to address the IP and the length of time we have patent protection or don't you want to do that right now?

Yeah, I would say this, like, you know, like discussing our patent and IP strategy on calls like this in the nuance details is probably not appropriate right now. I would stick to like mid thirties is where we are. And then, of course, there's always an IP strategy to try to generate additional intellectual protection property protection that that hopefully extends some of that protection.

Thanks. I think big figure we keep it to that for now. Thank you very much. Thanks. Any further questions?

We have. Would you like to take?

Yes, why don't we take one or two more and then we probably have to end the call and follow it up one on one. Yes, of course.

Of course, not a problem. And now we're going to take our next question then. And the question comes from the line of Kalpit Patel. Your line is open. Please ask your question.

Yeah, hey, thanks for taking the question. One more on the first line DLBCL study. I guess originally when you guys designed that protocol and had assumptions for that frontline study, is the timing of the readout, you know, fourth quarter more so in line with what you guys originally modeled when you first started the study? And then when you completed the enrollment, I believe in 2024, did that estimate, the timing estimate of the readout materially shift? And the reason I ask is because the start to finish still looks roughly in line between when Frontline and the Polarix study started and they finished. So any color on your model assumptions would be useful. Thank you.

We are super excited about the frontline setting. The readout will be in Q4. We believe that the data will be excellent based on the Phase 2 data. We're not going to address any further timing and timeline issues here, but look forward to the data.

Thank you. And now we're going to take our final question for today.

Just give us a moment. And the question comes line of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Thanks for squeezing me in. Comparing the frontline CRC trial with PETO to the ORAGAMI2 trial, they obviously look pretty similar in design, except for the PETO trial does include an ORR primary endpoint. Is this safe to assume you will try to explore product frontrunner in that frontline trial? And then just curious on RNA-S in non-small cell lung cancer. I've had a trial ongoing there this year. Any updated thoughts on the potential there when we might see some data from that Phase II trial? Thank you.

Thanks, Matt, for the questions. Tai, can you address both for the frontline CRC trial and also the non-small cell lung cancer trial data for RNA?

Sure. Yeah. So it's fair to assume that we will also explore, if it is opportune, project fund opportunities for colorectal for both trials. I think that is a fair assumption. And on the lung cancer RNA-S trial, once we have, I think, a data set that allows a robust discussion on what the next steps are going to be, I think it's a I think it's a proper and opportune time to present that data. I've said this many times, we're working in a super competitive environment. There's multiple fuller receptor ADCs from very large competitors that are coming left and right. And so I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. So we will present that data at a time when we also have the next steps ready.

Thanks Thij, thanks Matt. So thank you all for joining us today and thank you for that lively and invigorating Q&A with three super important phase three studies reading out in the coming months. We are well on track to deliver sustainable growth well into the next decades. We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. And as always, if you have questions for now, please reach out to our IR team.

This concludes today's conference call. Thank you for participating. Manal, all disconnect. Have a nice day.