Hello, and welcome to the Genmab Q3 2021 Conference Call. Throughout the call, all participants will be in a listen-only mode, and afterwards there still be a question-and-answer session. And just to remind you, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab 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 Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. So, today, I’m pleased to present Jan van de Winkel. Please go ahead with your meeting.

So, hello and welcome to the Genmab conference call to discuss the Company’s financial results for the first nine months of 2021. With me today to present these results is our CFO, Anthony Pagano, and for the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky and our Chief Operating Officer, Anthony Mancini. Let’s move to slide 2. As already said, we will be making forward-looking statements. So, please keep that in mind as we go through this call. Let’s move to slide 3. Genmab has a science-focused and innovation-based culture, and collaborations and partnerships have always been part of our DNA. During today’s presentation, we will reference some of the products being developed under the strategic collaborations, and this slide acknowledges those relationships. Let’s move to slide 4. Genmab has never been in a better position to achieve our ambitious vision of transforming cancer treatments. The solid foundation we have built is supporting our evolution and to a fully integrated biotech innovation powerhouse. We achieved a major milestone in this evolution during the third quarter with the FDA approval of tisotumab vedotin as TIVDAK. Let’s move to slide 5. Throughout Genmab’s history, we have been focused on using our deep antibody expertise to create and develop antibody products that have the potential to improve patients’ lives. And our five products on the market that incorporate our innovation and for the first time we in collaboration with our partner TIVDAK, Seagen, are in a position to bring our own medicine to patients. In September, approximately three weeks before the PDUFA date, the FDA granted accelerated approval for TIVDAK for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. As the first and only ADC approved in this indication, TIVDAK may provide a much needed…

Great. Thanks, Jan. Let’s move to slide 7. As I’ve done in the past, I’ll start with an overview of our financial framework and the related key drivers. First off, let’s think about our revenue profile. At the beginning of 2020, we had just one product on the market, which was DARZALEX, and today, we have five. For me, that’s just remarkable, to go from one to five products in less than 24 months. Now, on the left, you can see our recurring revenue streams, as TIVDAK, DARZALEX, Kesimpta TEPEZZA and RYBREVANT. Taken together, we expect them to generate significant cash flows for us in the years to come. Moving to the right-hand side of the page, as always, we continue to be focused in our investments. In particular, we are accelerating and expanding the potential winners in our pipeline. And we’re also investing in our commercialization capabilities for TIVDAK, ensuring we are ready to launch, should epcoritamab be approved. So, with that background, let’s jump into our Q3 numbers and take a look at DARZALEX sales on slide 8. We saw continued strong performance for DARZALEX in the first nine months of the year. You can see that in the chart on the left. Overall, DARZALEX sales grew by 49%, that’s net sales of approximately $4.4 billion, which translates to DKK 4.2 billion in royalty revenue. This exceptional growth was driven by continued strong market shares, across all lines and by the strong uptake of the SubQ formulation. So, DARZALEX remains a key driver of our revenue, as you can see on slide 9. Our recurring revenues grew by 52% in the first nine months of the year, primarily due to the higher DARZALEX royalties. We’ve already spoken about DARZALEX and the very strong performance there. So, moving to…

Thanks, Anthony. Let’s move to slide 14. As you can see, due to events in the third quarter we met a number of our 2021 key priorities and we anticipate meeting more of these very soon with the presentation of first-in-class, bispecific next-generation checkpoint immunotherapy data at SITC. We’re also looking forward to ASH this year. We will hold a virtual 2021 R&D update and ASH Data Review events following ASH on December 14th. Details about this event will be available on our website in the coming days. And over the past nine months, we have made great strides in our evolution into a leading, fully integrated, biotech innovation powerhouse. And we are looking forward to the rest of what has already been an extremely strong year. Let’s move to our final slide. That ends our presentation of Genmab’s financial results for the first nine months of 2021. Operator, please open the call for questions.

[Operator Instructions] Our first question comes from the line of Wimal Kapadia from Bernstein. Please go ahead.

Great. Thank you very much for taking my questions. So, could I just ask, there is a lot of attention on SITC on 1042, but I’m actually just curious more on the B7H4 target. First, I was unaware of it. So, just we’re seeing some preclinical data. I’m just curious to hear more, given that the expression of B7H4 is believed to be inversely correlated to PDL1. And given that combined with interesting preclinical data, how should we really think about this target and how you think it stacks up with the rest of your pipeline? And then, my second question is just on talquetamab, the GPRC5/CD3 bispecific, the ASH abstracts look quite compelling, particularly in combination with dara. So, I’m just thinking about how should we think about the profile of this molecule and how it stacks up versus some of the other BCMA bispecifics in development? Thank you.

Thanks, Wimal, for the questions. I will part the first one, because I will hand that over to Judith Klimovsky, and then let me address briefly talquetamab. I mean, talquetamab is an antibody from Janssen, and they are just using our DuoBody technology platform to actually target to the GPRC5D molecule that seems to be very, very efficacious. And I think, it’s up to Janssen to actually provide further perspective, Wimal, on how this one stacks up against the BCMA and against other targets. It’s probably not good for me to do that. But so, I will refer to Janssen to give more perspective, and they will certainly do that I think at ASH, because they are very, very excited about that program, I know. And the data is already flagged up together with dara look really encouraging, the first data. So, I think they have to position this one versus the teclistamab, it’s just got into Phase 3 I think last week, recording the first patient. So, that one is moving ahead very rapidly as well. So, let me pause there, Wimal, and hand the first question over to Judith Maybe Judith, you can give a bit more perspective on the CD3xB7H4 program. And we will have preclinical data, Wimal, also at SITC, which is upcoming. Judith? Judith, are you there? Maybe there is connection problem, Wimal. Let me address that one then…

Can you hear me now?

Yes, yes. Please go ahead, Judith. I think, we cannot hear you now. I think there’s a connection issue, Judith. So, should I answer this question then? So, B7H4, Wimal, is expressed actually very, very nicely on a number of solid cancers, and also at expression level, so it makes it a very, very good target for a CD3 bispecific retargeting approach. We have some very exciting preclinical data. Some of that data will be shared with all of you at SITC. And we believe, it fits up very nicely versus some other targets we are working on with CD3 retargeting approaches in our preclinical pipeline. So, we are very excited to actually start dosing the first patient almost imminently in the coming days or weeks, for sure. And then, we will do dose escalation and see how the safety profile looks like in our hands. But I think, there will be a lot more detail at SITC in the coming days. Maybe handing it back to the operator.

And the next question comes from the line of James Gordon from JP Morgan. Please go ahead.

Hello. James Gordon from JP Morgan. Thanks for taking the questions. One was also about SITC and the abstracts and for GEN1042 and GEN1046. Starting with GEN1042, I know there has been quite a bit of excitement about this product. But, if I read the abstract right, it looked like that 2 out of 49 patients had a response. So, it didn’t look like a very high ORR so far. But, what is it then that’s driven the excitement? Is it that there is a certain dose or tumor type or some other way in the data that looks a lot more exciting? And for GEN1046, the lung data looks good. I know there were these other nine cohorts. Have you seen data for other cohorts that do look promising for GEN1046, or should we really think about this as a drug that is for high PD-L1 expression lung cancer but probably not for other areas? But just based on this, we haven’t seen anything else in the 12 months, since the last SITC. And then, sort of a question is really just timing, and for EPCOR, the abstract looks very good. But in any update on what you’re thinking on timing for potentially earliest you could file it? Could that still be potentially a 2022 filing? And J&J arbitration, could that still be maybe H1 next year we might hear anything? What’s the latest thinking on timing for that and why that’s taking longer?

Thanks, James. Sneaking in four questions, actually, and you are allowed only one. But we will answer them, all four, I can assure you. The first two, I’ll probably hand over to Judith Klimovsky, if we can. Oh, I think we have a real connection problem there. But, let me start with the EPCOR question, James. We definitely are on schedule and we’ll aim for potential filing in ‘22 for -- in at least one indication. And we are very much I think aligned with AbbVie and the teams to allow us to do that. So that next year will be very exciting for epcoritamab. And I think the abstract data looks good. And I think the actual data at ASH which will be presented will be an update to the data and the abstract, James. So, we very much look forward to the ASH conference this year. Then, the final question, the J&J arbitration, I cannot really provide any further comments on timing because this is up to the arbitrators. What I can tell you is that the process is in the full swing. I think it’s going well from a technical side, and we very much hope that we will soon here from the arbitrators on the potential binding verdicts there to remove this potential overhang on the company, as soon as possible, and we definitely look forward to that. So, let’s see if I can bring Judith online here for 1042 and 1042. Judith?

Yes. Thank you. Can you hear me now?

Yes. Perfect. Okay.

Okay. I’m sorry for the problem in the connection. So, I will start by CD3xB7H4. So, as we know, bispecific, having successful in hem malignancies and also that in solid tumors. We think that our technologies and knowledge of the target put us in a better position to try to tap this holy grail of oncology. So, in essence, B7H4 is a great target, because it’s expressed in tumor cells, but it’s not expressed in normal tissue. And it’s expressed as we alluded in the abstract, and we see more data in a very common tumor type, but unfortunately are not well served today, particularly breast cancer, ovarian cancer, lung cancer and is inversely related, as you said, with the expression of PDL-1 pre-clinically. So, we are ready to move this to the clinic in the near future. And we -- just to test, because, as we know, I mean, it could -- cell therapies or bispecifics, having been able to modify that treatment paradigm of solid tumors. So, this is the tumors that we will study initially, if we -- after the dose escalation and we see a signal. This is with regard to CD3xB7H4. With regard to the second question was on GEN1042, correct?

Yes. The question was basically why are we so excited, but only 2 out of 49 respond or that is what James asked. What drives the enthusiasm, maybe a bit more color on 1042, Judith?

Yes. Thank you. So, as you say, we have two confirmed PRs, one in melanoma, one in lung [ph], but we are all overall enthusiastic about the 51% disease control rate, which is not to be disregarded, particularly taking into account the patient population which exhausted every prior line of therapy. And as you know, with immunotherapy, ORR is only one part of the story. But the way that immunotherapy works is usually modifying the time to event curve, not so much on ORR. So, we are excited, because given the patient population and given the CD40 target plus 4-1BB, we really expected limited activity in terms of tumor shrinkage. But the DCR, disease control rate is relevant in these tumor populations. Yes. And I don’t know if there were more questions when I was disconnected. I’m sorry again.

Just one more question on 1046. We basically have good data, and lung data which will be described of course at SITC. And the question is, well, did we also see data in other cancers to drive our enthusiasm or is a lung cancer only type program?

Yes. So, you will see more data in the poster soon, which is on November 12. But just, what we decided of the Phase 1 with expansion was to learn on the biology of this asset, which is so novel, particularly 4-1BB to guide us next step, and the totality of the data including in other tumor types speak to the same facts that we have seen in non-small cell lung cancer. So, the totality of the data is helping us to guide us on next step, lung and not lung.

Thank you, Judith, hopefully that pleases you, and then more to come at SITC in a few days. Back to the operator. Thanks, Judith.

And the next question comes from the line of Kennen MacKay from RBC. Please go ahead.

Hi. Thanks for taking the question and congrats on the commercial progress here. Maybe two questions, if I may. So, for Judith, relating to GEN1042, I wonder if you can talk a little bit more about the rationale behind the dose decision there. You mentioned, this is a little bit of sort of the goldilocks drug, right, just treating to the absolute max tolerable dose, potentially isn’t the right way to go here. So just again, wanting to understand the rationale behind the dose decision there? And then, maybe for Jan is, you’re narrowing the pipeline here. I’m always curious what in early stage pipeline you’re most excited about next. Thanks so much.

Thanks, Kennen. And I would like you to think about the 1046 question. So I can say that we are rigorous in our decision taking, Kennen as it relates to the pipeline. And we stopped two programs, as I said in my introductory remarks, the 5 program, and the 5T4 program. And I can tell you that the early stage pipeline is very, very exciting. We are very excited about the Duo HexaBody-CD37 program. And we will probably come with a short update this year and a more data kind of next year, and we can show the whole dose escalation data. And also the HexaBody-CD38 program is a very, very high interest and it’s moving ahead nicely. Also there, you will get this year the short status update from us, and then more on the dose escalation data next year in the New Year when we have all that data present. And then, we will also plan to move in at least two, but even more products, the new products into the clinical pipeline in the New Year in 2022. So ‘22 will be a very exciting year for the Company, I think, not only with the potential filing for EPCOR, initial funding for EPCOR but also, with hopefully moving one or two programs to the late-stage clinical development and that can also include programs like 1042, 1046, which are now on the radar screen basically of everybody. So, we are very excited about the pipeline, Kennen. I think, this has never been a stronger pipeline than it is right now. But, you will continuously have to read through and identify the real winner, potential winners and then stop the other programs because I think focus is very important. That has brought Genmab to where we are right now, focusing on the right molecules, on the right technologies to create differentiated antibody medicines. And I think we’re getting better and better in that. So, I think the quality of the pipeline is increasing. And not everything will work, but not necessarily because molecules are not active, but they are simply not competitive enough for our internal high standards as it relates to novel products. And we believe that we need to focus all of our attention and efforts, Kennen, and molecules that can be transformational. We believe that epcoritamab will be transformational for B-cell cancers. I think the data will show that which you will see hopefully also, again, we concern that at ASH. And we are now putting a very large military machine at AbbVie behind that program. So, I think the pipeline is in very good shape and we are very pleased with that. Let me hand over to Judith to speak a bit more about the dose -- the exact choosing of the doses for 1046. Judith?

Yes. Thank you, Jan. And we are presenting a poster at SITC semi-mechanistic PK/PD model where we put a lot of preclinical and clinical data to -- because as you alluded, there is this goldilocks effect or bell-shaped curve, and allow that to choose the dose of 100 milligrams as it’s the perfect dose for trimer formation. That means the trimer time between PD-L1, the bispecific and 4-1BB. And this is why it was chosen. And interestingly enough, when we filed the model, even with translational data, everything was very, very strong that at 100 milligrams is the dose where we optimize the trimer formation and the agonistic effect for 4-1BB. So, we are very confident with the dose that was selected, based on multiple data points that we put in the model.

Thanks, Judith. Hopefully, Kennen, that’s okay for you. Otherwise, you’ll get back to us separately in a call. Operator, maybe we can move to the next question?

Sure, yes. The next question comes from the line of Jonathan Chang from SVB Leerink. Please go ahead.

Hi, guys. Thanks for taking the questions, and congrats on all the progress. First question on the epco ASH abstract and relapsed/refractory CLL. I’m curious to get your thoughts on what the appropriate benchmarks are in this late line CLL setting. What kind of data would you need in this later line study to support development in earlier line CLL setting?

Thanks Jonathan for the question. I will hand it over to Judith. Maybe Judith, you can give some perspective on benchmarks for the very heavily pre-treated CLL for patients as we included in the first epco study.

Yes. Thank you for the question. So, it depends not only on the prior lines of therapy, but the categories of agents that patients got, and particularly whether they exhaust the BTK inhibitors and Venclexta or not. So, the population that we enroll was heavily pretreated, and most of them got BTK inhibitors and furthermore. Most of them had a very bad biological prognostic characteristics at 17P deletions. So there, the bar is low, unfortunately for those patients. So, it’s getting some level of remission, and durability is important. So, it’s not a single factor. As you know, [Technical Difficulty] because they are down the road. So, it’s response, it’s durability of response and tolerability.

Thank you, Judith. Thanks, Jonathan.

The next question comes from the line of Michael Schmidt from Guggenheim Securities. Please go ahead.

Hey, guys. Thanks for taking my questions. I had two questions. Another one on 1046, I think I heard you say that you’re planning a Phase 2 study in combination with pembro in relapsed-refractory non-small cell lung cancer patients. I’m trying to understand the rationale given that the bispecific antibody probably already blocks the PD-1 interaction. I’m just curious how much added or synergistic efficacy one would expect there and why. And then, the second question was on epcoritamab. I know you have the R-CHOP combo Phase 1 data at ASH. I was just curious how you think the Roche’s POLARIX result may potentially affect your plan to move epco into first-line DLBCL down the road. Thanks so much.

Thanks, Michael for the questions. I think, I will hand them over to Judith and then see whether I can add further perspective there. Maybe Judith, you can address both, the 1046 question and the epco R-CHOP question.

So, let’s start with 1046. As you have seen in the abstract, there are very important biological observations. So, in 26 patients that had tumor more samples to assess PDL-1 presence, those that were PDL-1 positive that were only 10 tumor samples from 10 patients, 7 had a tumor shrinkage. On the converge, 16 patients or tumor samples belonging patients that were PDL-1 negative, most of them, like 12 out of 16 had any -- no tumor shrinkage. So, there is a clear association between PDL-1 presence and the activity of this compound. We also show in the PK/PD model that the receptor occupancy for PDL-1 is not optimal, which is 100%. So, with PDL-1 4-1BB, because I said before that dose was selected to optimize the agonistic effect. We leave PDL-1 30% without inhibition. And we know from other PD-1, PDL-1 inhibitors in the market that for them to be fully active, we need like 100% of receptor occupancy. These plus the fact that as we show in the abstract, the activity that what we saw in the expansion is much more higher for those patients that were treated with the PD-1, PDL-1 inhibitor in the last eight months, and the receptor occupancy is still there than the patients that didn’t makes -- gives us the rationale that combining with a PD-1 inhibitor is the right next step to optimize the potential benefit of 1046.

Then, maybe the epco question, well, how the POLARIX may impact or diffuse large B-cell lymphoma front-line development strategy, Judith?

Yes. Thank you. So, we will hear more details on the POLARIX data at ASH. We only hear what everybody knows, like the high-level results. And based on the actual data, we will assess whether expanding more our clinical development plan or amending if necessary, and we will react accordingly. So, we are waiting for more results to understand how this could impact our clinical development plan.

And the next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

I’ve got a couple on 1042 and 1046, if I may. So, on 1042, Jan, I think the introduction listed a bunch of combination studies with KEYTRUDA or KEYTRUDA chemo combination. If I heard you correctly, the lung is a bit tough. And so, I just wondered what combination data you have that are supporting those combinations studies versus the mono data we’ve seen in the abstracts. The second question is, you very clearly commented on ORR and why we should focus on the disease control rate? I wanted you to comment on the second aspect that has been investor focus, which is the one grade 4 liver event? And how you think about that? And any further data you got on liver-tox there? The second question was on 1046. You referenced further development. I think your partner BioNTech said that the Phase 2 study was going to start in 4Q ‘22, next year. So, just wondering what’s taking so long for that study start? And then, I had a clarification question on what’s coming at SITC. It seems from Judith’s answer that we will be getting updated lung data and updated data on other cohorts, rather than just markers of response in lung, as we saw in the aspects. So, I just wanted to clarify that.

Thanks, Sachin. So, 1042 and 1046 are very popular, for sure. That keeps I think Judith quite busy. So, I will hand over both questions to you, Judith, and then I see that I can add. Maybe start with 1042 and the combi data, what events we have preclinically I think is probably the right angle here.

Yes. So, thank you, Jan. As Jan said, I mean, we have very compelling preclinical data of the synergy activity of 1042 plus pembrolizumab. And we -- the cohorts of combinations of 1042 plus pembro are in clinicaltrials.gov. And I am pleased to tell you that we are actively enrolling. So, we expect to have actual clinical data of the combination in coming months. So, it’s moving nicely. So, this is for 1042. The other question on 1042 was the live tox or the tox in general. In general, 1042 is very well tolerated with most of the safety events, grade 1 or grade 2. We have seen 10% increase -- in 10% of the patients increase AST, ALT [ph] elevation; grade 3 or above, only a 6%. That means two patients. So, we are following. But so far, it seems manageable. And percentages are what we consider a very well tolerated and very well tolerated range. So, this is for 1042. Any other question on 1042, if I am missing?

No. I think you can move to 1046. And the timing of the Phase 2, I think that caused some confusion, I think caused by our friends at BioNTech.

So, we are expecting to finalize a randomized Phase 2 to assess more data. So, we have some expansions ongoing in different combinations or in different settings that will guide us of the next steps on the randomized Phase 2. So, everything is moving. So, we are waiting to data sets coming from the current expansions to guide us of the activation on the randomized Phase 2, which will occur next year.

Thanks, Judith. And then, maybe some comments on the data from other cancers within 1046 at SITC, maybe a bit on what type of data basically?

Yes. So, thank you. And I alluded to that before, what we -- the data that you will find in the poster is aligned -- in the other solid tumors aligned with the biological signals that we found for non-small cell lung cancer. In terms of the PD-L1 expression and in terms of finding their biological rational to guide us on next steps. So, these include a non-small cell lung cancer and other tumor types.

Very clear. Can I take one follow-on on 1042 pembro combo data you referenced is coming in the next months? Could you be more specific on that?

Yes. Thank you. Yes. Can you hear me?

Yes.

Okay. So, we amend the protocol and it’s updated in clinicaltrials.gov that we added cohorts of combinations with pembrolizumab in head and neck, in non-small cell lung cancer and in melanoma. So, those data sets will guide us on next decisions. And we expect to have these data in next months.

Thanks Judith. So, these cohorts are recruiting very quickly, yes, Sachin. So, I think that is a reflection of our enthusiastic data about 1042 as well. But, I think more to come at SITC and then certainly more to come next year.

It comes from the line of Matt Weston from Credit Suisse. Please go ahead.

Thank you. Can I ask a cost question, please? So, obviously a key element of the guidance raised for this year was a change in the cadence of spending. I’m very interested in how the change in cadence of spending is then going to run into 2022. Jan, you’ve outlined a raft of new trials, which are starting. Clearly, you have a lot of commercial opportunity in terms of setting the scene for your early portfolio and the launch. So, any comment on how we should anticipate the cadence of costs going into ‘22 would be very helpful. Thank you.

Thanks, Matt, for the question. I will hand it over to Anthony Pagano. As you know, he will give guidance in February next year. But, maybe let’s see whether Anthony can provide a bit more color for you, Matt. So, Anthony, please go ahead.

First of all, you’re right. With the expense run rate for the first nine months, costs were a bit on the low side relative to our previous full year guidance, so. And our revised guidance and range of DKK 5.3 billion to DKK 5.6 billion in OpEx, as you’re kind of pointing out, is due really to timing of our investments for certain R&D activities and overall organizational capability we have built. The R&D expenses were impacted really around phasing of costs related to various pipeline programs. So, here for me, it’s really a matter of timing, and we expect costs related to our R&D activities to ramp up in the coming quarters. Again, but it’s important to understand, this is really aligned with our overall strategy and our key priorities, and we’ll continue to be focused and disciplined as we move forward. As a reminder, Jan alluded to this, for epco together with AbbVie, we are planning to start a number of late-stage trials in the coming quarters. On SG&A, our focus in the short-term is really on the launch of TIVDAK and also preparing for potential epco launch. And it’s important here to highlight that this will also entail as we’re heading to potential epco launch but this will also entail additional investments in building the commercialization infrastructure and pre-launch activities. So overall, the revised ‘21 guidance on OpEx primarily reflects shift or phasing. So, I think Matt, the key takeaways is that, look, we have a wonderful business, solid set of technologies, exciting pipeline, and we’re evolving to become this fully integrated biotech. We’re starting off with TIVDAK. We’re super excited about the opportunity there. But moving forward, we are all eyes and we’ll be super focused on epco as we move forward, both from a development as well as a commercialization readiness perspective. More to come in terms of our exact business plan activities and our guidance, ultimately here for 2022 as we move forward, particularly around our ‘21 -- our earnings release in February.

Next question comes from the line of Peter Welford from Jefferies. Please go ahead.

I’ve got just two left. Firstly just on 1042, wonder if you just talk a little bit about the selection of the dose for that molecule? You talked a bit about 1046. 1042, are you also looking to optimize the transformation and also the agonistic effect for 4-1BB? Or are there other factors to bear in mind for this? Can you just talk a little bit about how you got to the recommended beta test for the expansion cohorts? And then, secondly, just with regards to the J&J DuoBodies. It might just be an emission and for simplicity’s sake. But it looks as though, according to your pipeline chart that other than teclista and talquetamab, I said this right, so, the other programs like the CD3 [indiscernible] CD33, PSMA, are now admitted, they are in the clinic. Is that just the simplicity, or has J&J decided to focus its DuoBody collaboration now on teclistamab and talquetamab in the remaining programs? Thank you.

So, I hand over the both questions actually to Judith, and then see where I can add on the J&J question. Judith, maybe on 1042, a bit more color on the dose selection and the dose finding?

So, in case of CD40, 4-1BB, both are agonistic targets and both have what we call the goldilocks effect. So, we did a [Technical Difficulty] based on PK/PD. And the dose of 100 milligrams is the dose that optimizes the trimer formations for both targets, CD40 and 4-1BB. So, we are very confident that this is the dose. This is why we didn’t even escalate till MTD, because we have the optimal biological dose at 100 milligrams. So, we feel very confident with the dose. The second question was regard to the J&J DuoBody platform. This was a question on other assets?

Exactly. They have seven basically in the clinic. And Peter asked, why are we focusing on amivantamab, teclistamab and talquetamab, what about the others basically?

Yes. I mean, what we know is what is in the public domain and the assets that have data on the public domain, who makes us excited about, for sure. Amivantamab, teclistamab and talquetamab. So, they are early on and there is no too much in the public domain for us to be excited about.

Exactly, Peter. So, they’re still in the clinical development, some of them are post recruiting, other are basically recruiting as we know standard that we actually decided to focus on the more interesting, exciting ones that either moving into Phase 3, like teclistamab or are already on the market, like amivantamab and also in Phase 3 and talquetamab is triggering a lot of enthusiasm right now, it’s in Phase 2 and probably also will move to further lines of clinical developments soon. And then, there is still I think potential for one or two of the others, Peter, to also move forward, but we decided to put less emphasis on that.

Our last question comes from the line of Asthika Goonewardene from Truist Securities. Please go ahead.

I’d like to start off, maybe one to Judith. On GEN1042, two-part question here. Is there any rationale for this drug in the monotherapy setting, or is this largely going to be a combination? And then, also on GEN1042, will you be look at serial biopsies? And what do you expect to see in terms of T-cell infiltration into the tumor microenvironment? And I’ve got a couple of follow-ups.

Thanks, Asthika, for the questions. And Judith, I think I will keep you busy today. So, these will both be for you.

So, thank you for the question. We think that GEN1042 should be developed in combination because of the biology of CD4 and 4-1BB. So, this is why we targeted the combinations early on. And as I said, we are already enrolling 1042 plus pembro and there are two other cohorts in clinicaltrials.gov in combination with chemo plus/minus pembro. So, it’s clearly the biology of these compounds needs something else and this is we’re adding to, this is the combination. Then, your second question is a great question. And one of the cohorts in 1042 is a melanoma cohort with a very heavy translational research component. Part of it is pair biopsies that will allow us to understand in depth the integration of the tumor with lymphocytes and other pharmacodynamic markers of activity, which are really relevant because of the novelty of the target. And as we put in the poster and put in the abstract, and you will see more data in the Phase 1, we’re able to modulate a TARC, which is very important because that means that this compound is really targeting CD40 and activated dendritic cells, which is what we want from 1042. So, more to come as we gather more data that the biological rationale and premise behind the compound is being shown in the Phase 1 and with the pharmacodynamic markers, and we are including these in the abstract and you will see more in the poster.

Thanks, Judith. Asthika, any follow-up?

Yes. Jan, I think we understand last year, you -- when asked the question, what are your top priorities for -- your top three priorities for 2021? I think you’ve kind of articulated 1046, 1042 and epco. If we asked that same question for 2022, what would you say?

Yes. These are still the top three priorities but you’ll add actually a number of other to that. So, the company gets, I think broader and I think also, I think, increasingly professionally organized. So, I think we will actually broaden our pipeline, Asthika. And as already alluded to in an earlier question, we’re very excited about some of the early stage clinical programs. We believe that some of them have the potential to move to late stage. So, we will still keep these three as top priorities, Asthika, but probably CD37 and CD38 to those priorities for ‘22.

Great. Thanks for taking my question, guys.

Thank you. Thanks, Judith. Operator, are there any further questions?

There are no further audio questions. I’m handing back to you.

All right. So, thank you for calling in today to discuss Genmab’s financial results for the first nine months of 2021. If you have any additional questions which later come up, please reach out to our Investor Relations team. We hope that you all stay safe and remain healthy and optimistic. And very much look forward to speaking with you again soon.

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