Genmab A/S (GMAB) September 2026 Conference Transcript

This session at the Morgan Stanley Global Healthcare Conference. We're very excited to have the team from GenMab, Jan, and Tayy with us. Let me just get through a quick disclosure. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morgansanly.com forward slash research disclosures. I'm Judah Fromer, one of the SMID biotech analysts here at Morgan Stanley. Like I said, very excited to have GenMab here for this session. So I thought we could start out with key updates since we saw you here last year. Maris is, of course, the biggest, but how have the other aspects of your business evolved over the past year from a high level?

Thank you, Judah. I'll be delighted to be here, and I'm delighted to update you all on the progress of the company because we have made a lot of progress. We have now nine medicines where we generate revenue from. We have three late-stage assets, which are all expanding their reach for the coming time. So we have actually now six new Phase III trials this year and more to come. and also we will have a lot of data in Q4. Essentially all of the three lead programs will generate phase three data in Q4, so we're very excited. And then, of course, the financials look very solid. We increased the revenue by 25% in the first half and operating profit by 18%, so very solid financials, which will allow us to invest actually in further expanding the late-stage programs and also preparing for commercial launches, multiple launches next year, assuming the data will be very good and follow the phase two data. So it made a lot of progress and delighted to be back in New York here.

So maybe starting with Maris and pitocentumab, what drew you to the asset? How is it differentiated from other EGFR by specifics in recurrent metastatic head and neck cancer and CRC? Maybe just initially, kind of what drew you to that acquisition?

Yeah, I can start off on that and I'll let you fill in a bit more of the differentiation part. But pitocentumab is a truly differentiated next generation EGFR targeting antibody with great pre-clinical data, very, very good early clinical data and had a neck cancer, two breakthrough therapy designations, two phase threes. One of them will read out in Q4 and then the other one, the second, third line, had a neck cancer, will read out in Q1 immediately thereafter, so very well progressing. Data are really, really good on a numerical basis, really outperform potential competitors there and also colorectal cancer. We have now announced on August 6 two new Phase III trials, one in front-line and second-line colorectal cancer. You will hear the reasons why at ASMO, end of the October time frame, where we will actually describe the Phase II data, which was originally from Meris, where we more than doubled the number of patients and then also followed them up for a much longer period of time. But I will let Ty speak a bit more on differentiation versus other HFR-targeting antibodies.

I think this goes back to the thesis that we were formulating when we actually announced that we were going after males. As Jan was saying, it's a second-generation EGFR, it's quite specific. Second arm is against third GR5. And what we saw, and I think what continuously to play out, was very early on, which is what triggered our interest, that it appeared to have a differentiation on the efficacy. It's like in cross-study comparisons are always hyper-problematic, but in every data set that is in the public domain, in monotherapy in combination with PEMBO in the head and neck space, in combination with a few or four fox in the front line or second line, there's always like a numerically higher response rate vis-à-vis, for example, Amivantamot. And on the other end, and that's probably equally important, it also seems to be differentiated on the safety side. um so it doesn't it doesn't have the degree of of of skin problems it doesn't have the scalp skin uh issues that that amybantamap is dealing with which then is managed with the whole kung kung regimen doesn't seem to have the degree of somatitis and all of these things and they in totality then and this is kind of like a theme in general they help patients stay on drug and duration of treatment eventually then also becomes duration of response. And these things together higher efficacy, longer duration treatment they tend to drive then this package that we're looking for that really is differentiated for the patients. That's what we saw and this is what's playing out right now in the long term follow up data sets, some of which are going to be presented at Esmo and so we're really excited about it. We're really excited about the readout that we announced is going to happen in this quarter and so we all look forward to having a conversation about that.

Great and maybe just we got the question from time to time Was LGR5 on your radar as a target, or was it really the clinical data that stood out and kind of introduced you to the target?

The question whether we went after an EGFR by specific... LGR5. Oh, LGR5. No, I think, like, you know, the story of LGR5 is obviously an interesting scientific story. It came out of the Hupac Institute. It was an observation that this is a stem cell target. If you really dig into the history of PETO, So it was screened in an organelle model. Scientifically, it was super intriguing. And in the end, both Jan and me came out of the lab. We are scientists. But ultimately, it is actual clinical data. And so it becomes very difficult to do attributes, whatever profile you see. But in totality, as it is, as a biospecific with these two targets, it has a certain clinical behavior. And that's what we were attracted for. but that's what we were doing the diligence on, and that's what drove the enthusiasm to do really a major transformational step for JemUp, and this is why we're so excitedly waiting about the first readout, the confirmation of our excitement.

Okay, great. And like you said, Jan, we'll get the front-line data in the fourth quarter this year, that's the LIGR HM1 trial. So that'll be a top line. I guess, what can you tell us in terms of data communication? What should we expect to be in that press release? You tend to focus, and correct me if I'm wrong, on primary endpoint and safety, but how are you thinking about the communication around those data?

Yeah, definitely, as we do with other phase 3s, and there will be multiple phase 3s, hopefully reading out in the coming time, top-line results, and also a statement on safety, because that is, of course, the second parameter which is really important for new candidate medicines, is that they are not only efficacious, but also have a good safety profile, because that, in combination, will actually predict how successful they can be as a new treatment option. So that is what you can expect for the frontline head and neck cancer data for pitocentamol. And then further details will then be presented at a medical conference, hopefully sooner after Judah, with more color, of course, on subsets of patients and other parameters, secondary readouts, et cetera.

Okay, great. And maybe just remind us of the timing of the decision to increase enrollment in those LIGR trials. Any detail you can share around drivers of that decision, I think, you know, like we've talked before, the timing of when you made that decision is important for investors around that.

I can defer to Ty, for sure, because we already made that decision in the summer last year before we actually approached Ameris, but Ty, you can give it a bit more color.

Yeah, I think that decision, and that has gotten a lot of, like, press over this week, was one of the first things that we talked about when we were looking in the diligence, that we wanted to increase the sample size for both lines just to basically capture sufficient number of patients in this, what is, in the end, a heterogeneous disease. And it's, by the way, not only heterogeneous by HPV positivity, but it's also locality. And so we did that. And I think there was a debate whether this would have a timing impact on enrollment. And so they both, in what we said from the beginning, It won't have an impact on the enrollment. It didn't. And so, yeah, I don't think getting into the details of why we make these decisions is a little bit too much.

Maybe just on that point, maybe help us with unmet need in head and neck, kind of what response rates in OS look like, if PREMBO is the right benchmark currently, and maybe how that helped.

Well, so if you look at the current standard, right, essentially you are faced with two choices. You have PEMBOR monotherapy or PEMBOR chemotherapy. Made of which is really attractive. PEMBOR has like a 19, depending on what study, somewhere between high teens to low 20% response rate. The PFS then is automatically driven by the non-responders, and the OS is driven by the responders, and it's roughly about a year. chemotherapy doesn't really actually change much on these dynamics it is just an option that then gets taken if a patient has a tumor that is in a certain locality that requires a more immediate intervention broadly speaking that is the response rates are slightly higher the overall survival is exactly the same so they are both to be honest some of the most dismal outcomes in any front-end indication in cancer if you really think about this and put this into context how much progress we have made in other disease areas. So the promise of the pito-pimbo combination is, if you take the phase two data sets, that you roughly would triple the response rate. You roughly triple the PFS rate, and then that has a significant impact on the overall survival. And you essentially now have a regimen that would not have the toxicities of chemotherapy, and these patients are really frail. they're beaten up, their locality is problematic, they are more often also in a bad stage because of the risk factors that lead to the disease. Having essentially a non-toxic or outside of the IRR, relatively well-telebrated regimen that has such a magnitude of improvement in efficacy, disease control, and then durability, I think one could argue if that would actually play out in the phase three, that that would be transformational. And so that's what we're looking for.

Okay.

That's all. So like you said, the phase two sort of set a high bar for PETO, right? Objective response rate, 63%. I think it was a nine-month medium PFS and 79% 12-month OS, right? But I guess, like you said, given the background you mentioned on standard of care, where do ORR and OS need to be to be kind of commercially meaningful as the potential first mover of the next gen by specifics? You know, I guess, what has physician reaction been in terms of, you know, could we see, you know, data maybe come down a little bit from the phase two?

So, look, I mean, if it is going to be in the ballpark of what the phase two is, it is going to be careful with the words one used prior to, like, having the data, but it's going to have a transformation impact on the care of patients with metastatic recurrent neck. That's without a doubt. If you look at the speed by which these trials are involved, that gives you a hint. If you see the sense that it's building in the community around waiting for this data, that gives you a hint. I think there's a significant amount of anticipation for this data, including in general. And if it is going to be somewhere in the ballpark, which we are very confident it will be, then I think...

Yeah, I guess in our KOL conversations, in the ballpark is great, but that ballpark is so far away from what standard of care is getting these days that, you know, it's one of these instances where, you know, like investors and doctors maybe have different views on what's good data, but, you know, that's good to know. Yeah, we have to believe it, right?

So we have to see it. But we are pretty excited about getting the data in our hands.

Okay, great. And then you mentioned just, you know, kind of, you know, HPV being a driver of some subset of head and neck. Is the goal to be an HPV agnostic asset, could we potentially see messaging around efficacy in HPV negative disease in particular at some point? I guess kind of what's the approach here in terms of HPV status?

Yeah, so I think two things can be true at the same time. When we say agnostic, we're not meaning that it behaves exactly the same way. What we're saying is the combination of pettopembro in our minds, based on what we know so far, will have a meaningful differentiated impact on the standard of care, regardless of which of these two buckets you fall in, because these two buckets behave also differently to the embryo. And so that's what we're saying. And so the idea is to provide this medicine, this new innovation, if you will, with that hopefully repeated magnitude of efficacy. All patients. Now, there is a difference between HPV positive and HPV negativity in terms of how they respond to AGFR. That's not only true for PETA. It's true for every AGFR antibody. And there is a biological reason for all of that. It's actually more like the oropharyngeal subtype that seems to then coexist. But particularly in the front line, I think we're very comfortable with the idea that the data that we're going to generate, the data that we've so far generated or that mail was generated and that we inherited points very clearly to the fact that regardless of HPV positivity and negativity, there is a differentiation.

And like you said, we're going to get LIGR HN2 data first quarter of next year. How should we think about level of OS benefit and kind of meaningfulness there? And will having OS data on hand support positioning versus maybe in AmiVentimab or other competition?

Well, so the sequence of events is going to be first things first, right? So we're going to have, hopefully, a positive readout on the front-line study, which I think will settle a lot of questions in the investor community, but also in the Gemma minds around the place and the role that Peter will play in head and neck, because that's just the dramatically larger space in terms of patients. And the second line, monotherapy OS study, well, first of all, it is an OS study, right? What Janssen has is an accelerator pool. It's a little bit trickier here to benchmark OS, to be honest, because there's a lot of different data sets that are sometimes conflicting, which is why it's good to have this in a randomized trial to actually control for that. We're very positive that this trial will also be positive on OS, And then you would have, you know, in the totality of benefits, a very enormous and comprehensive picture about the role of PETO in head and neck that is, you know, frankly not comparable to, like, a face that it looked like. And then Janssen's strategy is actually going in combination with chemotherapy, which is also completely different. So we feel very good about the program that we inherited on these two studies. We feel very good about the data that we have so far seen, and we are very excited about these two readouts, which are going to underwrite what we said from the beginning, a position for PITO to be the best in class or in front line, EGFR, second generation EGFR by specificity. Okay, great.

And maybe just before we wrap up the head and neck conversation, you know, competition in this space and additional assets kind of, you know, coming down development pipelines is great for patients, but maybe just remind folks how many centers PITO has been investigated in, kind of level of familiarity for head and neck specialists with PITO at this point in time.

So how many sites have been tried out of these two trials? I think there's some overlaps, but it's a number that's north of 300 sites. I think essentially every major network in head and neck, and being a major investigator on Head and Neck across the mostly Western world in one way or the other is part of the PITO program. Those kudos to those collaborations to actually draft this program.

Okay, great. And then maybe we spend a few minutes on CRC, right? I think when you bought Maris, you indicated Head and Neck was really the focus for the return on that investment, but you're clearly making progress in colorectal as well. So maybe just briefly describe the planned front-line and second line plus studies, trial design, you know, arms of those trials? And is there inherent differentiation in design versus competitor CRC trials? I'm going to take that question again.

I think so. I will take over pretty soon. Okay, good.

Well, first things first, right? So we started two phase threes in front line and second line, correct, as you were pointing out. In front line, I cited last while type roughly 900 patient study against Fofox or Fofuri in combination with. In second line, and that's already where there's a little bit of differentiation, same population, slightly smaller study, Fofox, Fofuri combined with Cytuximab or Bevacizumab. So that's one part, slightly broader in the intended population label. And while we at the time said that the idea was underwritten, I think that's what the wording was. So the deal was underwritten by the head and neck data. We had looked at every single colorectal patient, and it had, of course, been part of our fantasy and our imagination. And then the only way you actually get an active study enrolling patients in September when you close the deal in January is that you actually started to work on this already value and diligence. So we were from the beginning, but we're having our eyes very closely on this data. There's going to be more data coming up, sometime soon to also drive this this uh enthusiasm for for everybody to see as i said many times these are small phase two data sets one has to be careful americally they look incredibly uh very promising and also in comparison cost comparison to army and again i it's it's not about only efficacy it's also what um so we're really excited about this core vector of space now that's opening up we're gonna run these studies as fast as we have found other studies and hopefully we'll then be able to catch up on some creative regulatory pathways that exist but let's get the data first

and conceptually of course it is very logical to go for colorectal cancer because algebra 5 was originally described as part of part of the wind signaling pathway and the the bispecific primeras were screened on organoids from colorectal cancer and that is what this one really differentiated versus hundreds of other bispecifics so so i think conceptually it really makes a lot of sense to go for colorectal cancer and yes We were a lot more enthusiastic than we actually displayed publicly because I was worried actually that our deal would be threatened between September last year and December with the party being too enthusiastic about colorectal because when you think it through, potential market size of colorectal is like three times bigger than had a neck cancer. So this could make this a very sweet deal for Genmop. So I'm happy that we have now executed the deal on December the 12th and we're now progressing with two phase three trials with colorectal cancer. And that's not all. I can tell you that we will further expand the PETA program and we will further expand the RENA program pretty quickly. That is what we're focusing on right now. So super enthusiastic.

And what should we think about in terms of efficacy benchmarks in frontline and second-line plus CRC for clinical?

Well, again, this is a little bit of a tricky population now because a lot of the older trials, they have some of the patients in there that are now taking out a market-driven approach. So it's a bit tricky to estimate this. But if you just think about it, I think, like, the overall response rate right now for PETO in combination with chemotherapy is in the high 80s. There is a lot of space in there between what is currently standard of care with cetuximum and what would be the combination data. So we feel very comfortable about that. In second line, it's even wider. Yeah, and that also then tells you a story to a degree. I mean, what's doing second dinosaur? And so now we're running like a high six version of like 30, 40, more 50%. Right. So, again, we feel very excited about this trance. You know, I forgot to mention this, but it was good that you reminded us. It was actually a drug that was selected to be a codorectal NSAID drug because of the biology of the wind pathway. and so the data will be presented as you get to see it a little bit more a little bit more follow up has at every step kind of like reconfirmed this initial enthusiasm maybe another anecdote on all of this the first document that left the house after the deal was signed 24 hours after the deal was signed was the request for an IND maybe we'll move over to Epkinlee maybe just talk about the current growth that's coming from second-line follicular lymphoma versus third-line plus DLBCL.

What's the biggest barrier to broader community adoption currently, even though you're making progress there?

You're making significant progress there with a lot of adoption in the community setting, and that is driven by the second-line follicular lymphoma. It's also driven by the fact that this is one T-cell engager targeting both diffuse-rass B-cell lymphoma and follicular lymphoma, which is much more straightforward for community health care centers. A very good safety profile. It's easy to give. It's like a two-second injection under the skin. Remember that in front-line and second-line B-cell cancers, these patients want to be treated close to their homes and not in a cancer hospital four hours flying from their home or a university hospital. So we see a lot of traction right now. In fact, most of the adoption is now coming from the community centers. So very encouraged by that. looking forward to the front-line readouts in Q4, because that is basically the largest part of the market. It's essentially half of the potential target market for AppKinley. So super enthusiastic, but we also see traction now in other territories. The second-line was approved last year in November in the U.S., and this year in China and Europe. Japan is around the corner, literally, so we are going to expand also in other settings there. and also we have of course now also the positive data on the second line, the diffuse B cellopharma, combination with linalidomite where we're also speaking with multiple regulators at different parts of the world right now so I think there's a good momentum now and you've seen it, I mean 48% growth year over year I already said it in my introductory remarks 28% quarter over quarter going from first quarter to second quarter beating competitors quarter after quarter after quarter with T-cell engagers targeting CD20, I think we're in good shape and actually the best shape possible because we are going to have the frontline data probably a year to one and a half years sooner than some of the main competitors. And I want to remind everybody that in the original third-line plus label and the fuselage piece in the form of Judah, we had like a 29-day difference between us and the competitor. We have beaten them quarter by quarter, every quarter since. So I think time really helps. and that is what you should all be aware of for GenMob. GenMob is a new company now, but we're focusing on the really truly differentiated molecules and very good execution because execution is what matters, what we see not only for Hapkinli, where we knew that we already had a number of competitors. We see it with Peter, where we just spoke about that. These two key competitors now moving in. Rina, where we hopefully will also spend some time on today because it's such an exciting molecule. We see the big ones, the Ostrus, the Lilies and other companies coming in, also with next generation, folate receptor alpha ADC. So what it comes down to is very good execution. And we have now set up the organization that we can do this in a very effective way. And I think the acceleration of the ARENA-S phase three shows that for this year, the very rapid coming to the frontline data and had a neck cancer with the P2-Centamab acid. And then we're also super excited about having the frontline diffusel of B-cell lymphoma combination trial with our CHOP, which is the gold standard already for 24 years, and we can beat that. I think we have a good presence also in visa cancer. So I think that all in all brings a very, very exciting picture for the company. Definitely.

So maybe just on that front line of the LBCL trial, we'll also get a data card flip in Q4. In terms of a PFS hazard ratio, we're not looking to pin you down on a number, but I guess also a ballpark that, you know, experts are thinking about, that could really transition EPCNLE to standard of care on Frontline.

Yeah, so the ice is cracking under my feet, so I'm going to walk very slow. First off, first, let's stay with what we communicate. So we're going to have a readout this year, and that is very exciting, and I'm very confident about that to be able to present that. There's a lot of mathematical models out there. a lot of the questions that I have in the past have received as well as ARCHOP does ARCHOP behave the way that ARCHOP behaves you know, all things are being true and equal you know, polarics, front mind even other studies it tends to, in a certain way in a very narrow band we are looking with excitement at this data and then once we have the data I think we can have a conversation about what it means for the community one other point maybe to go back a little bit to the first question. The reason that we were really intensely focused on working with the agencies, particularly the FDA, on getting the hospitalization requirement out of the label, and there was a significant effort. There was a separate study that was done in the community to show that it can actually be done, at least within the U.S. healthcare system, where the community often is also a term that describes distance. And then with with the regimens, the steroids regimens that control the CRS, all of this was done in preview and in anticipation and pre-planned to be in place by the time we would get the frontline data because there, as Jan was saying, these patients are actually in the community and that's where they are going to get treated. And so you're going to not have an impact on the disease unless you have a regimen that is, you know, can be administered by labor restriction or regardless of labor restriction, but just the practicality of how it's been administered in the community. And so the whole story about Epkini was always about that. So the sub-Q administration, the ease of route, the control of the CRS. And so in totality, you see this now playing out. The current indications also with signiforinical forma have allowed us to penetrate the community in the U.S. significantly, and this is creating now confidence and experience in preview of hopefully what will be exciting data on the few such. I think it doesn't really make sense to speculate where the PFS. I mean, the only thing I will say is this. It's a disease where a segment of patients get cured, right? And so one has to take that into mind when one starts to think about PFS. The most positive, if you look at the rituximum study, I think that's maybe like the ceiling, if you think about it. The rituximab study had a hazard ratio 0.4.

And maybe just the last one here, just the need or the potential to show benefit in both GCB and...

Oh, with the cell of origin? I don't think there's really a reason to believe, and we've never seen anything, that the cell of origin matters for T-cell redirection. This comes a little bit, I think, partially driven by the Polarix data set. Without getting too scientific, right? the essay that you use is probably equally important to the determination of a self-origin in the actual data. It's a very subjective, at the fringes it is not, but at the overlap. So it was never pre-specified, so I don't really know why. We don't have a reason to believe that it behaves differently in any of these data that I've seen, neither from what Russia has ever put out in the public domain from their trials, nor what we've seen with the kidney with, I don't know, thousands and thousands of years doesn't seem neither do actually other historical prognostic factors to a degree when you have a new mechanism sometimes what happens is like you reset the whole discussion about which factors and quite certainly will in the end hopefully when this trial is positive have a discussion about completely different physical or clinical attributes that describe a subset of patients that may not necessarily benefit as much from T-cell inhalation than others. But that's a discussion for you.

And I want to make sure we touch on RENAS, like you said. So, we'll get a face-to-face out there in P-ROC Q4 as well. I guess, how are you thinking about differentiation versus mervituximab specifically? And then, you know, given activity across folate receptor alpha expression levels, could you avoid a companion diagnostic with RENAS?

Yeah, so I want to be polite to my friends at Abbey, but I don't think my vitroxomil is part of this conversation. I think when the data will come out, we'll have to phase two data, and then we'll have to phase three data. We'll end up having a conversation about a completely different treatment paradigm and plug. What we've seen so far, of course, like the initial strategy is 35 and above, and that's a regulatory strategy because it's the easier part. What we've seen so far is that RINA-S has a 50% in totality, not always the same by these subgroups, and again, the same story that I've repeated this many times. When we say it has a meaningful impact across the spectrum for the receptor alpha expression, we're not saying that it's equal in each one of them. it's not um but it has a meaningful and by the way the dd the dd inequality comes the response but more to the duration that's by the way true for merv too if you look at the old merv files the response rate was not necessarily much lower um you know after the 30 response rate and 75 and above um and then they had like a high 20 response rate and below it was the duration of response which basically made it impossible because they actually had a failed phase three and then they went back here go back in history alone so for me now what we've seen what we we continuously communicate because this is what we believe this is what we have in our hands is that full receptor alpha expression the way it is determined again what happens is actually as for polymorphisms of full receptor alpha you only measure one with the with the assay the way it is determined does not really identify a population that would not benefit so we have a benefit across the entire spectrum of folio receptor alpha expression from negative all the way to to the very high we believe the data is going to be transformational it is incredibly well tolerated it doesn't have eye toxicity it doesn't have neuro toxicity the duration of treatment is extremely long in the phase two the data set we were talking about a duration of response that in aggregate was exceeding 12 months across the entire spectrum so there's like different segments they did the discontinuation rate due to a ease was percentage single percentage it's the same story or once you get the control over the neutropenia and you little settle on your on your on your dose there's really no reason why patient discontinue and so we are very excited about the part this study will be a very important study for Gemma but

I think we could keep going, but I think we'll park it there for a time. Thank you very much for being here. We appreciate it. Thank you.