Q3 2021 Genmab A/S Earnings Call

Hello, and welcome to the Genmab Q3, 2021 conference call.

Unknown Executive: 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 will be a question and answer session.

Throughout the call all participants will be in a listen only mode and afterwards, there will be a question answer session and just to remind you. This conference call is being recorded joined.

Unknown Executive: 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. However, actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

During this telephone conference you may be presented with forward looking statements that include words, such as believes anticipates plans expects.

Actual results may differ materially for example, as a result of the late or unsuccessful development projects Gen.

Unknown Executive: Genmab is not under any obligation to update statements regarding the future or 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 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.

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 a website for more information on Genmab and our privacy policy.

So today I'm pleased to present, yet, but the wrinkle. Please go ahead with your meeting.

Unknown Executive: 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. Now, let's move to slide two. As I have already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. Now, let's move to slide three.

So how long will come to the Jumbo conference call to discuss the company's financial results for the first nine months of 2021.

With me today to put some of these results is our CFO Anthony Pagano afford a Q&A, we'll be joined by our Chief Development Officer, Chlebowski handle Chief operating officer, Anthony amongst many left.

Let's move to slide two.

I've 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 three.

General pace of science focused and then the patient base sculpture and collaborations and partnerships have always been part of our DNA.

Unknown Executive: 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 these strategic collaborations, and this slide acknowledges those relationships.

During today's presentation, we will reference some of the products being developed under these strategic collaborations and this slide acknowledges those relationships.

Let's move to slide four.

Unknown Executive: Genmab has never been in a better position to achieve our ambitious vision of transforming cancer. The solid foundation we have built is supporting our evolution into a fully integrated biotech innovation powerhouse. We achieved a major milestone in this evolution during the third quarter with the FDA approval of Tizotamab prodotin as TIFDAG. Now, let's move to slide five.

<unk> never been in a better position to achieve our ambitious vision of transforming cancel treatments.

The solid foundation, we have built a supporting our evolution into a fully integrated biotech innovation powerhouse.

We achieved a major milestone in this evolution during the third quarter with the FDA approval of the saltwater Dota nesters deck.

Let's move to slide five.

Two O gem ox history, we have been focused on using our deep antibody expertise to create and develop antibody products.

Unknown Executive: 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. There are now five products on the market that incorporate our innovation. And for the first time, we, in collaboration with our partner in TIFDAG, CIGEN, are in a position to bring our own medicine to patients. In September, approximately three weeks before the PDUFA dates, the FDA granted accelerated approval for TIFDAC for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. As the first and only ADC approved in this indication, TIFDAC may provide a much needed new treatment option for patients.

The potential to improve patients' lives.

There are now five products on the market that incorporate our innovation and for the first time, we collaborations with our doctors on based on <unk> CGM all in a position to bring our own medicine to patients.

In September approximately three weeks before the producer dates the FDA granted accelerated approval for <unk> for recurrent or metastatic cervical cancer the disease progression on or after chemotherapy.

That's the first and only ADC approved in this indication this deck may provide a much needed new treatment option for patients.

Unknown Executive: This incredible achievement was only possible because of the efforts of our dedicated and talented team, the excellent collaboration with CJEOM, and the patients, families, and caregivers, as well as the nurses, physicians, and study teams who participated in our clinical trials. TIFDAC was available for qualifying patients 48 hours following approval, and Genmab and Sejian are co-promoting TIFDAC in the USA. We look forward to providing you with further updates on the launch of DevDeck in due course.

This incredible achievement was only possible because of the efforts of our dedicated and talented talented team.

The excellent collaboration with teacher and the patients families and caregivers as well as the nurses physicians and study teams who participated in our clinical trials.

<unk> was available for qualifying patients 48 hours following approval and jump in season, a co promote just stuck in the USA.

We look forward to providing you with further updates of the launch of Tesla can do course, so now let's look at slide to slide six and look at some of the other recent achievements in our pipeline and beyond.

Unknown Executive: So now let's look at slide six and look at some of the other recent achievements in our pipeline and beyond. In addition to the exciting approval in collaboration with Cijan, we also have a broad clinical development program in place for Tisotoma fedotum. Notably, data from the INNOVATIVE-205 study, which combines tesotem and fedotin with other therapies and in earlier stages of cervical cancer, were presented during an oral session at ESMO in September.

In addition to the exciting approval in collaborations with CGM. We also have a broad clinical development program in place for these sorts of adulthood.

Notably data from the innovators to five study this combines desalt about for dose them with other therapies and in earlier lines of cervical cancer. What's the percentage you in an oral session at ESMO in September.

Also in September dose escalation data from the Umpqua NHL, one study of Epcot heat them up.

Got it in development at Abbvie was published in the law sets.

More recently announced abstracts accepted for presentation.

Unknown Executive: Also in September, escalation data from the EPCOR NHL-1 study of EPCOR Ritamab, a product in development with AbbVie, were published in The Lancet. More recently, ASH announced abstracts accepted for presentation. We are very pleased that there will be multiple presentations of EPCORITAMOB data, including preliminary results at CLL, as well as data for EPCORITAMOB in combination with ArtShop and in combination with Revlimid and Retuxan. Additionally, some of our other dual body programs will be featured later this week at the CETC conference.

Very pleased that there will be multiple presentations of Africa hit them up data, including preliminary results CLO I saw this data of for aggregate them up in combination with R chop and in combination with Revlimid and that took some.

Some of our other duopoly programs will be featured later this week at the Citi Conference.

Presentation is fueling this events include the first preclinical presentation of a new duopoly program dual body CD three b 784.

And for the products, we are developing with biotech there will be a rapid oral on dose escalation data for jumped 42.

And a poster presentation on the expansion cohort data for Gen 10 46.

Excitingly, they're also pipeline updates for both of these programs.

Unknown Executive: Presentations during this event include the first preclinical presentation of a new dual body program, Dual Body CD3B7H4. And for the products we are developing with BioNTech, there will be a rapid oral presentation on the escalation data for Gen1042 and a post-op presentation on the expansion cohort data for Gen1046. Excitingly, there are also pipeline updates for both of these programs. A Phase II study of Gen1046 as monotherapy and in combination with Pembrolizumab in patients with recurrent or refractory metastatic non-small cell lung cancer is anticipated to start before the end of this year.

A phase II study of Gen 10, 46, as monotherapy and in combination with Penn police them up in patients with recurrent or refractory metastatic non small cell lung cancer is anticipated to start before the end of this year.

In addition, the ongoing phase one two study of <unk> 42 was recently updated to include multiple expansion cohorts in combination and in additional indications. These.

These include a Gen 10, 42 in combination with some police them up in first line non small cell lung cancer and.

In first line head and neck squamous cell carcinoma, and <unk> melanoma.

And in combination that Tumblr lease them up.

Alicia mob and chemotherapy in first line head and neck squamous cell carcinoma and in first.

First line pancreatic ductal adenocarcinoma.

At this time, we would also like to inform you about some further changes to our pipeline.

Following the recommendation of our portfolio boards, you have decided that we will not advance the development of <unk> five.

Unknown Executive: In addition, the ongoing Phase I-II study of Gen 1042 was recently updated to include multiple expansion cohorts in combination and in an additional indication. These include Gen1042 in combination with pembrolizumab, in first-line non-small cell lung cancer, in first-line head and neck squamous cell carcinoma, and in first-line melanoma, and in combination with pembrolizumab and chemotherapy, in first-line head and neck squamous cell carcinoma and in first-line pancreatic ductal adenocarcinoma.

In agreement with our partner Abbvie dual body city 354.

As I stated previously a general would be a very high efficacy standards for for our clinical pipeline and we are rigorous in our decision taking.

Politicians are driven by data and initial resource for both programs shows daiwa insufficiently competitive compared to other product candidates in all in a robust next generation antibody product pipeline.

With our goal of transforming the lives of patients in mind, we look forward to continuing to progress our strong clinical candidates and to bringing additional candidates into our pipeline as we continue to create and develop truly differentiated antibody products.

In this context I'm pleased to inform you that we expect to dose the first patients had dual body CDP be 784 imminently.

Unknown Executive: At this time, I would also like to inform you about some further changes to our pipeline. Following the recommendation of our portfolio boards, we have decided that we will not advance the development of Hexabody DR5-DR5 as agreed with our partner, AbbVie, for DuoBody CD3-5T4. As I stated previously, at Genmab, we have very high efficacy standards for our clinical pipeline, and we are rigorous in our decision making. Policies are driven by data, and initial results for both programs showed that they were insufficiently competitive compared to other product candidates in a robust next-generation antibody product pipeline.

The power of Gem Ox innovation is also reflected in products being developed by other companies. Just last month. You also received a positive opinion from the C. H M P.

Commending conditional approval conditional marketing authorization in the EU, So I'm in front them up for the treatment of adult patients with advanced non small cell lung cancer with activated Egfr exon 20 insertion mutations.

After failure of platinum based therapy.

If approved by the European community It would be the first approval of <unk> in the European Union.

Therapy created using our proprietary dual body technology.

Sort of validation for the dual body technology is reflected in two other areas first multiple duopoly products in development with our collaboration partners are anticipated to enter phase III development piece.

Unknown Executive: With our goal of transforming the lives of patients in mind, we look forward to continuing to progress our strong clinical candidates and to bringing additional candidates into our pipeline as we continue to create and develop truly differentiated antibody products. In this context, I'm pleased to inform you that we expect to dose the first patient with dual-body CD3B7H4 imminently. The power of Genmab's innovation is also reflected in products being developed by other companies.

These include youngsters to lift them up and Novo Nordisk MIM eighths.

Both published clinical trials start golf.

Second as you may have recently seen there will be data from youngsters to lift them up and go create them up at Ash <unk>.

Including in combination with Dara took them up.

We are very encouraged to see focus in theory is dual body programs and look forward to seeing data from products leveraging our world class duopoly technology at Ash in December.

Dr selects continues to evolve.

And for subcutaneous Dara to Mop is now the only approved therapy for al Amyloidosis in China in Gabon.

Sales in the first nine months of the year were also strong and J&J reported.

<unk> 4370 $8 million.

Unknown Executive: Just last month, Janssen received a positive opinion from the CHMP recommending conditional marketing authorization in the EU for amifantamab for the treatment of adult patients with advanced non-small cell lung cancer with an activating EGFR exon 20 insertion mutation after failure of platinum-based therapy. If approved by the European Community, it would be the first approval in the European Union for a therapy created using our proprietary Duobody technology. Further validation for the dual-body technology is reflected in two other areas.

And the net sales an increase of 49% over the first nine months of 2020.

Resulting in 4000 to 167 million Danish krone and royalties to churn model.

I will now turn the call over to Anthony who will discuss our revenue in more detail and then Anthony the floor is yours.

Great. Thanks, John.

Let's move to slide seven.

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, yeah, just one product in the market, which was <unk> and today, we have five.

Unknown Executive: First, multiple dual-body products in development with our collaboration partners are anticipated to enter phase three development. These include Janssen's The Clister Mob and Novo Nordisk's MIM-8, both published on clinicaltrials.gov.

For me extra remarkable to go from one to five products and less than 24 months.

Now on the left you can see our recurring revenue streams.

Tim Dec, Darkle X to simply to Pizza and Robert Van.

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're accelerating and expanding the potential winners in our pipeline.

Unknown Executive: Second, as you may have recently seen, there will be data from Janssen's Keklistermap and Talquetermap at ASH, including in combination with Dara Tugumalp. We are very encouraged to see progress in various dual-body programs and look forward to seeing data from products leveraging our world-class dual-body technology at ASH in December. Darcelax continues to evolve, and subcutaneous daratumumab is now the only approved therapy for AL amyloidosis in China and Japan.

And we're also investing in our commercialization capabilities for Tim Dec and ensuring we are ready to launch should <unk> be approved.

So with that background, let's jump into our Q3 numbers and take a look at <unk> sales on slide eight.

We saw continued strong performance for <unk> in the first nine months of the year.

You can see that in the chart on the left.

Overall <unk> sales grew by 49% that's net sales of approximately $4 $4 billion, which translates to $4 2 billion kroner and royalty revenue.

This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the sub Q formulation.

So <unk> remains a key driver of our revenue as you can see on slide nine.

Anthony Pagano: Sales in the first nine months of the year were also strong, and J&J reported $4,378 million in net sales, an increase of 49% over the first nine months of 2020, resulting in 4,167 million Danish kroner in royalties to Genmab. I will now turn the call over to Anthony, who will discuss our revenue in more detail. Anthony, the floor is yours.

Our recurring revenues grew by 52% in the first nine months of the year, primarily due to higher <unk> royalties.

We've already spoken about <unk> and the very strong performance there.

So moving to Cassandra.

We're encouraged by the nice quarter over quarter growth seen in the first nine months of the year here sales grew by 64% in Q3 versus Q2.

As you know we didn't report any royalties for deposits in the first quarter due to the supply chain disruption.

But horizon recommit supply in April and reported strong sales in the second and third quarters.

Anthony Pagano: Great. Thanks, Jan. Let's move to slide seven. As I have 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.

<unk> sales grew by 36% in Q3 versus Q2.

Taken together.

<unk> generated 524 million kroner of royalties for the nine months ended 2021.

<unk> to $179 million for the same period last year.

That's growth of $345 million in it.

It's really illustrates the power of our recurring revenues.

We're also enthusiastic about the approvals of ride prevent and Tibet and look forward to seeing how sales progressed for both of these.

So our revenue profile continues to get stronger with increases both in recurring and nonrecurring revenue. After excluding of course, the one time upfront payment from Abbvie in 2020.

Anthony Pagano: Now, on the left, you can see our recurring revenue stream. That's Tivdak, Darzalex, Kesimpta, Tepeza, and Rybervan. 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 on our investment.

And we're taking our strong recurring revenues and investing in a highly focused way as you can see on the next slide.

Total operating expenses grew 38% in the first nine months of the year and here you can see where we invested.

We continue to accelerate our investment in our product portfolio, especially the expansion of both echo and dual body PDL 141 DB.

We've also continued to invest strategically on expanding our team hiring key team members to support our growing product pipeline.

Anthony Pagano: In particular, we're accelerating and expanding the potential winners in our pipeline, and we're also investing in our commercialization capabilities for TIVDAC and ensuring we are ready to launch should EPCR to MAB be approved. So with that background, let's jump into our Q3 numbers and take a look at Darzalech 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.

And we've continued to build our commercialization and broader organizational capabilities to support our expanding pipeline and increasing capabilities for our own commercial products.

And finally, we're leveraging the abbvie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs.

Now, let's take a look at our financials as a whole on slide 11.

Here, you can see our summary P&L.

For the first nine months of the year revenue came in at approximately $5 9 billion kroner.

60% on last year, if we exclude the one off payment from Abbvie in 2020.

Anthony Pagano: Overall, Darzilek's sales grew by 49%. That's net sales of approximately $4.4 billion, which translates to 4.2 billion kroner in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the sub-Q formulation. As a result, 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 higher Darzalex royalties. We've already spoken about Darzalex and its very strong performance there. So, moving the cassette up.

Total expenses were about $3 7 billion with 79% being R&D and 21% and G&A.

And our operating income came in at a very strong $2 2 billion.

Our net financial items amounts to income of $808 million, which was primarily driven by the strengthening of the U S dollar against the Danish kroner on our U S dollar denominated cash and investments.

Then we have our tax expense of $725 million, which equates to an effective tax rate of 24%.

And that brings us to a net income of around $2 3 billion.

So as you can see extremely strong financial performance for the first nine months of the year.

Now, let's take a look at our guidance on slide 12.

Given the continued strong numbers in the last quarter once again improved our 2021 guidance.

We now expect our revenue to be in the range of seven nine to $8 5 billion kroner, driven primarily by the continued strong growth of <unk>.

Anthony Pagano: We're encouraged by the nice quarter-over-quarter growth seen in the first nine months of the year. Here, sales grew by 64% in Q3 versus Q2. As you know, we didn't record any royalties for Tepeza in the first quarter due to the supply chain disruption.

Our Opex guidance is now in a range of $5 three to $5 6 billion, a decrease compared to the previous guidance driven primarily by the timing of some of our investments in R&D activities and organizational capability build.

We anticipate that will continue to step up our investments in Q4 and the following quarters in line with our overall strategy and key priorities.

Putting this altogether, we're planning for substantial operating income in 2021, and a range of two three to $3 2 billion.

Anthony Pagano: But Horizon recommenced supply in April and reported strong sales in the second and third quarters. Here, sales grew by 36% in Q3 versus Q2. Taken together, Kissinta Intipeza generated 524 million kroner of royalties for the nine months ended 2021, compared to 179 million for the same period last year.

And now for my final Slide let me provide a few closing remarks.

In summary, we've had a very strong first nine months.

Create a growing recurring revenue streams based on products with exceptional growth profiles and that gives us a backbone of significant underlying profitability.

And we're investing those revenues and a highly focused way to realize our vision and capitalize on the significant growth opportunities in front of us.

Anthony Pagano: That's growth of $345 million, and this really illustrates the power of our recurring revenue. We're also enthusiastic about the approvals of Rybervent and TivDeck and look forward to seeing how sales progress for both of these. So our revenue profile continues to get stronger with increases both in recurring and non-recurring revenue after excluding, of course, the one-time upfront payment from AbbVie in 2020. And we're taking our strong recurring revenues and investing in a highly focused way, as you can see on the next slide. Total operating expenses grew 38% in the first nine months of the year.

On that note I'll hand, you back to Jan to discuss our key priorities.

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 as we anticipate meeting more piece very soon that the presentation of first in class by specific next generation checkpoint immunotherapy data at 50.

We are also looking forward to ash this year.

We will hold a virtual 2021, R&D updates updates and data in a few events are following us 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 Genworth financial results for the first nine months of 2021, operator, Please open the call for questions.

Anthony Pagano: And here you can see where we have invested. We continue to accelerate our investment in our product portfolio, especially the expansion of both EPCO and dual body PD-L1-4-1DB. We've also continued to invest strategically in expanding our team, hiring key team members to support our growing product pipeline. And we've continued to build our commercialization and broader organizational capabilities to support our expanding pipeline and increasing capabilities for our own commercial products. And finally, we're leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership program. Now, let's take a look at our financials as they fall on slide 11. Here you can see our summary P&L. For the first nine months of the year, revenue came in at approximately 5.9 billion kroner.

Thank you and if you do wish to ask a question. Please press <unk> one on your telephone keypad now.

Our first question comes from the line of women <unk> from Bernstein. Please go ahead.

Oh, great. Thank you very much for taking my questions.

So could I just ask.

I know, there's a lot of attention.

City on 102, but I'm actually just curious more on the B seven H for target.

First of all I was unaware of it. So just first of all we're seeing some preclinical data.

I'm just curious to hear more given that the expression of <unk> seven page four is believed to be inversely correlated to PDL one.

And given that combined with the interesting preclinical data how should we think about this target and how do you think it stacks up.

With the rest of your your pipeline.

And my second question.

Is just on.

Telco, Tim at the GPC up five.

Cdti by specific the Ash abstracts look quite compelling, particularly in combination with Dara. So I'm just thinking about how you know how should.

Should we think about the profile of this molecule and how it stacks up versus some of the other DCM APAC specifics and development. Thank you.

Anthony Pagano: That's up 60% on last year if we exclude the one-off payment from AbbVie in 2020. Total expenses were about $3.7 billion, with 79% being R&D and 21% in G&A. And our operating income came in at a very strong $2.2 billion. Our next financial item amounts to income of $808 million, which was primarily driven by the strengthening of the U.S. dollar against the Danish kroner on our U.S. dollar denominated cash and investments. Then we have our tax expense of $725 million, which equates to an effective tax rate of 24%.

Thanks to the mall for the for the questions I'll Park. The first one because of I'll hand that over to Utica Mosqui.

And then let me address briefly talk create them up I mean calculate them up is it's an antibody from Johnson.

And they are just using our dual body technology platform to actually.

Talk to the <unk>.

Molecule it seems to be very very efficacious and I think it's up to Johnson to actually provide further perspective.

On how this one stacks up against the <unk> and against auto targets, it's probably not.

Good for me to do that but so I will refer to Johnson 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 already flagged up to get all the data look really encouraging the first data. So so I think we have to position dish.

Anthony Pagano: And that brings us to our net income of around $2.3 billion. As you can see, an extremely strong financial performance for the first nine months of the year. Now, let's take a look at our guidance on slide 12. Given the continued strong numbers in the last quarter, we have once again improved our 2021 guidance. We now expect our revenue to be in the range of 7.9 to 8.5 billion kroner, driven primarily by the continued strong growth of Darzaleh. Our OPEX guidance is now in a range of 5.3 to 5.6 billion, a decrease compared to the previous guidance, driven primarily by the timing of some of our investments in R&D activities and organizational capability building.

<unk> sources to cliffs from up it's just got into phase III I think last week.

In the first patients. So that one is moving ahead very rapidly as well so let me pause there the mall and hence the first question overdue unit, maybe you that you can give a bit more perspective on the PD <unk> four programs and we will have preclinical data we model all sweat.

<unk>, which is upcoming units.

Here to tell you there.

Maybe there's a connection problem BMO, let me address that one.

Them ourselves.

Okay.

Yes, yes, Okay go ahead.

I think we cannot hear you now.

I think there was a connection issue units so.

Should I answer this question then.

So be stephanie's for B malls as expressed actually very very nicely on a number of solid cancers and also at.

That's a expression levels, let's make it a very very good targets for <unk> bi specific.

Anthony Pagano: We anticipate that we'll continue to step up our investments in Q4 and the following quarters in line with our overall strategy and key priorities. Putting this all together, we're planning for substantial operating income in 2021 in a range of $2.3 to $3.2 billion. And now for my final slide, let me provide a few closing remarks. In summary, we've had a very strong first nine months. We've created growing recurring revenue streams based on products with exceptional growth profiles, and that gives us a backbone of significant underlying profitability.

Re targeting approach we have some very exciting preclinical data some of the data will be shared with all of you at <unk> and we believe it sets up very nicely versus some other pockets. We are working on the <unk> III re targeting approaches.

In our preclinical in our preclinical pipeline. So we are very excited to actually start dosing. The first patient almost eminently in the coming days or weeks for sure.

And then we will do a dose escalation and see how where the safety profile looks like.

Our hands, but I think there will be a lot more detail at <unk> in the coming in the coming days, maybe maybe handing it back to where due to the operator. Thank.

Anthony Pagano: And we're investing those revenues in a highly focused way to realize our vision and capitalize on the significant growth opportunities in front of us. And on that note, I'll hand you over to Jan to discuss our key priorities. 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 bi-specific next-generation checkpoint immunotherapy data at CIDC. We're also looking forward to ASH this year.

Thanks Raj.

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

Hello change going to take a moment and thanks for taking the questions.

One was also about <unk> C in the abstracts and output Jane wanted to call to enjoy one of the four six.

Is it starting to take my call too.

And have been quite a big excitement about this product if I went to abstract right.

49 patients had a response it didn't look very high Oh, I'll say, Paul but.

Is it then that's driven the excitement.

In dose to achieve a type or some other way if let's say during the day to them, it's a lot more exciting.

And Tim on April six the lung data looks good.

These are the main cohorts have you seen data.

Due to the promising preliminary forsakes or should we really think about this is a drug that is behind PD, one, especially in lung cancer.

Unknown Executive: We will hold a virtual 2021 R&D update and ASH data review event following ASH on December 14. 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.

Not further areas because based on that we haven't seen anything else in the 12 months since the last etsy.

Then.

Yeah.

Two other quick questions really just timing and Cody I stated it very good and any update on what youre thinking and planning for potentially LDC could pilot cadets coast to be potentially a 2022 filing.

And J&J arbitration could that still be maybe age for next year. We want he wouldn't thing what's the latest thinking on timing for that and why that's taking longer.

Thanks, James for Sneakers are sneaking in four questions actually and you allowed only one that we will answer them all.

<unk>. The first two are probably hand over to you that colonoscopy, if again going back to an automated voice messaging system.

Unknown Executive: Let's move to our final slide. That concludes our presentation of Genmab's financial results for the first nine months of 2021. Operator, please open the call for questions. Thank you. And if you do wish to ask a question, please press 01 on your telephone keypad now. The first question comes from the line of Wilma Kapadia from Bernstein.

Online too.

Q1 zero.

Oh, I think we actually have a real connection problem there.

The Agco, let me start with the <unk> question, James we definitely are on schedule and.

We will aim for potential filing in 'twenty two.

This one indication.

We are very much I think aligns fit to the taxi and the teams to allow us to do that so that next year will be very exciting for accurate them up and I think the.

Unknown Executive: Please go ahead. Well, great. Thank you very much for taking my question. So, could I just first ask... I know there's a lot of attention on SIDS-C on 1042, but I'm actually just curious about the B7H4 target. For the first time, I was unaware of it, so this is the first time we're seeing some preclinical data. I'm just curious to hear more given that, you know, the expression of B7H4 is believed to be inversely correlated with PD-L1.

The abstract data looks good and I think the actual data at ash, which will be a percentage will be an update to the data and the FX. James So we very much look forward to the <unk> 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 processes in full swing I think is going well from a technical side that is very much hope that we will soon here from the arbitrators on a on a potential binding verdicts day or to remove this potential overhang on the comp.

Unknown Executive: And given that, combined with the interesting preclinical data, how should we really think about this target and how do you think it stacks up with the rest of your pipeline? And then my second question is just about Telquentamab, the GPCR5 CD3 bispecific. The abstracts for the ash abstracts look quite compelling, particularly in combination with DARA. So I'm just thinking about how, you know, 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.

As soon as possible.

We look forward to that so that I can think of.

Units online here for 10 42.

Six units.

Okay. Thank you can you hear me.

Now yes.

Yes perfect.

Okay, I'm, sorry, pardon me I'm proud of them and they go next sensor.

Steve Please CEB seven eight or so as we know by having sex.

Successful in heme malignancies.

So that in solid tumors.

That our technologies and.

Now each of the targets put us in a better position to try to cap the Holy Grail.

<unk>. So in advance of the 784 is a great target because it's expressed in tumor cells, but it's not expressed in normal tissue and his expertise as we can.

Unknown Executive: Thanks, Vimal, for the questions. I will put aside the first one because I will hand that over to Judith Klimovsky, and then let me address briefly talcuitamab. I mean, talcuitamab is an antibody from Janssen, and they are just using our dual-body technology platform to actually target the GPRC5D molecule. It seems to be very, very efficacious, and I think it's up to Janssen to actually provide further perspective, Vimal, on how this one stacks up against the BCMA and against other targets.

That's correct that we've seen more data in a very common to amortize that unfortunately, it's not well served today.

And particularly with breast cancer ovarian cancer lung cancer and is even verticals.

David.

The expression of PDL one per community. So we are ready to move this to the clinic in the near future and then we test the test because as we know I mean, it could be that piece or bi specifics, having being able to.

To modify that treatment paradigm ups, how do you feel like this is Doug.

Initially.

We ask that you dose escalation.

Right.

This is with regard to <unk>.

Each board with regard to the second question was on <unk> correct.

The other question was basically why are we so excited but only two out of 49 responder status for James.

Unknown Executive: It's probably not good for me to do that, but 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, as you already flagged up, together with Dara, look really encouraging, the first data. So I think they have to position this one versus piclizumab.

So what drives the enthusiasm maybe a bit more color on 10 42.

Yes. Thank you. Thank you.

We have two confirmed Prs one in melanoma, one in Latin net but we are all of it all.

Yes, Dave about 51% disease control rate.

Not to be the lead, particularly taking into account the patient population, which exhausted every prior line of data.

Unknown Executive: It's just gotten to phase three, I think, last week, recruiting the first patient, so that one is moving ahead very rapidly as well. So let me pause there, Vimal, and hand the first question over to Judith. Maybe, Judith, you can give a bit more perspective on the CD3B7H4 program, and we will have preclinical data, Vimal, also at CIDC, which is coming soon. Judith, are you there? Maybe there's a connection problem, Vimal.

And as you know with immune of data or arity is only one part of the story, but the way that even when I say that the way it is usually.

Modifying the time to advance Paris, not so much on on <unk>. So we had anxiety because given the patient population and you then and the CD four T M.

Platform <unk>, we really expected need may be the activity in terms of tumor shrinkage, but.

Unknown Executive: Let me address that one by myself. Can you hear me now? Yes, yes, please go ahead, Judith. I think we cannot hear you now.

DCF VCR disease control rate.

It's available in these tumor population.

Yes.

There were more sales when I was disconnected I'm sorry, the other one.

Unknown Executive: I think there was a connection issue, Judith, so... Should I answer this question now? So B7H4, Vimal, is expressed actually very, very nicely in a number of solid cancers and also at expression level. So it's making 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 CIDC, and we believe it stacks up very nicely versus some other targets we are working on with CD3 retargeting approaches in our preclinical pipeline.

One more question on 10 46, we basically have good data.

And then one.

<unk> data, which will be described of course at 50 and the question as well that we also see data in other cancers to drive on two shifts.

Lung cancer only type program.

Yes, so we will see more.

In the past we tease.

TS on November 12.

What we did state that of the phase one with expired.

Was to learn on the biology of this asset which is an all in particularly for one BV to guide next steps and the totality of debate that including in other tumor types.

Unknown Executive: 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 in our hands. But I think there will be a lot more detail at CIDC in the coming days. Maybe handing it back to the operator.

Speak to the fact that we have seen in non small cell lung cancer. So the totality of delay days without lost enough to guide us on next steps Lang Lang.

Thank you our units are James hopefully that places you in there and then more to come at <unk> in a few days.

Back to the operator, thanks for that.

And the next question comes from the line of Kennan Mackay from RBC. Please go ahead.

Unknown Executive: And the next question comes from the line of James Gordon from J.P. Morgan. Please go ahead. Hello, James Gordon from JPMorgan. Thanks for taking the questions. One was also about SITC and the abstracts that are now out for GEN1042 and GEN1046. Starting with GEN1042, I know that there has been quite a lot of excitement about this product, but if

Alright, Thanks for taking my question and congrats on the commercial progress here.

Maybe two questions if I may as well for Judith relating to 10 46, I Wonder if you can talk a little bit more about.

The rationale behind the dose.

Vision that you'd mentioned.

Little bit of sort of a goldilocks.

Drug, we're just treating too the absolute Max tolerable dose.

Unknown Executive: [inaudible]

Potentially the right way to go here. So just again wanted to want to.

Unknown Executive: For Gen 1046, the lung data looks good, but I know there were these other nine cohorts. Have you now seen data for other cohorts that do look promising for Gen 1046, or should we really think about this as a drug that is promising?

To understand the rationale behind the decision there and then maybe maybe for Don is you're narrowing the gap.

Pipeline I'm always curious what.

In the early stage pipeline Youre most excited about.

Thanks, so much.

Thanks, Ken and I would ask you to think about the 10 46 questions. So I can tell you that we are rigorous in our decision taking kind of as it relates to the pipeline and so we stopped two programs as I said in my introductory remarks, the <unk> program.

Unknown Executive: This is a drug that is for high PD-L1 expression lung cancer, but probably not for other areas, but just based on them, I haven't seen anything else in the 12 months since the last HC.

Unknown Executive: I've got two other quick questions, really just timing, and for EPCO, the asteroids look very good, but any update on what you're thinking on timing for potentially the earliest you could file it? Could EPCO still be potentially a 2022 filing? And J&J arbitration, could that still be maybe H1 next year? We might hear something.

And the 54 program and I can tell you that.

The early stage pipeline is very very exciting we are very excited about that.

<unk> exceeded 37 program I will probably come at a short update this year on a more data kind of next the next year. When we can show the whole of dose escalation data and also the <unk> 38 program is a very very high interest and it's moving ahead nicely also data you will get this year the short status.

Updates from from US and then more on the dose escalation data next year in the new year. When we have all that data presence and that we will also plan to move in at least two perhaps even more of products new products into the clinical pipeline in the new year in 2022 to 22 will be a very exciting year for the company.

Unknown Executive: What's the latest thinking on timing for that, and why is it taking longer?

Unknown Executive: Thanks, James, for sneaking in four questions, actually, and you allowed only one, but we will answer them all, all four, I can assure you. The first two I will probably hand over to Judith Klimovsky, if we can get her back. Forwarded to an automated voice messaging system. 8 6 2 2 1 0, Oh, I think we have a real connection problem there.

Not only with the potential filing for <unk> initial filing for <unk>, but also with hopefully moving one or two programs to the late stage clinical development that that can also includes fulghum slide 10 $42 46.

Unknown Executive: But the APCO, let me start with the APCO question, James. We definitely are on schedule and will aim for potential filing in 2022 in at least one indication. And we are very much, I think, aligned with APFI and the teams to allow us to do that. So next year will be very exciting for APCO Ritemap.

No.

Although the.

On the radar screen basically of everybody. So we are very excited about the pipeline kind of and I think it has never been a stronger pipeline than it is right now, but <unk> continuously have to weed through and identify the.

The real then a potential vendors and then stop the other programs because I think focus is very important that has brought them up to where we are right now focusing on the right molecules on the right technology.

Unknown Executive: 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 in the abstracts, James. So we very much look forward to the ASH conference this year. Then, on 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 full swing.

<unk> technologies to create <unk>.

Differentiated antibody medicines, and I think we're getting better and better than that so I think the quality of the pipeline is increasing and not everything will work.

But not necessarily because molecules on effective but they are simply not competitive enough.

Our internal high standards.

As it relates to novel products, and we believe that we need to focus all of our attention and efforts.

Unknown Executive: I think it's going well from the technical side, and we very much hope that we will soon hear from the arbitrators on a potential binding verdict. They are to remove this potential overhang on the company as soon as possible, and we definitely look forward to that.

And molecules that can be transformational we produce at <unk> will be transformational for b cell cancers, and I think the data will show that.

As you will see hopefully also again reconfirm that at Ash and we are not putting a very large military machine that etsy behind that program. So so I think that pipeline is in very good shape.

Unknown Executive: So let's see if I can make a unit online here for 10.42.6. Judith. Thank you. Can you hear me now?

And we are very pleased with that let me hand over to two years.

Unknown Executive: Yes, perfect. Okay, I'm sorry for the problem. So I will start with C33B7H4. So as we know, bi-specific having been successful in heme malignancies, no SUDAD in solid two. 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, C7H4 is a great target because it's expressed in tumor cells, but it's not expressed in normal tissue.

A bit more about the dose.

The exact choosing of the doses 410 46 units.

Yes. Thank you, yes, and we are presenting a poster at Cts.

Let me make that mistake PK PD model, where we put a lot of preclinical and clinical data.

Two because <unk>, Steve Goldy lock effect or bell shaped curve.

And allowed us to choose the dose of 100 milligram.

Unknown Executive: And it's expressed, as we alluded in the abstract, and we'll see more data in a very common tumor type that, unfortunately, is not well served today, particularly breast cancer, ovarian cancer, lung cancer, and is inversely related, as you said, to the expression of PD-L1 preclinically.

Perfect those four Mega formation that means the time between PDL, one the bispecific and four one DB.

And this is why it was chosen and.

Interestingly enough when we the more they'll even with translational data everything was very base at all that at 100 milligrams is the dose where we optimize the primary coordination and they add when he speak FX for.

Unknown Executive: So we are ready to move this to the clinic in the near future, and we just need to test it because, as we know, I mean, it could sell therapies or, by specifics, having been able to modify the treatment paradigm of solid tumors. So these are the tumors that we will target initially if, you know, we have started off escalation and we see a signal. This is with regard to C7H4.

So we are very.

Im confident we build those Bachelor Lake, Steve based on multiple data points that we put them all of them.

Thanks, Thanks for that hopefully calendar.

It's okay for you otherwise you will get back to that got back to us separately and Nicole.

Operator, maybe we can move to the next question sure.

Unknown Executive: With regard to the second question, which was on 1042, correct? Yeah, the question was basically, why are we so excited with only 2 out of 49 respondents? That is what James asked. What drives the enthusiasm?

Next question comes from the line of Jonathan Chang from SVP Leerink. Please go ahead.

Hi, guys. Thanks for taking me gents and congrats on all the progress.

First question on the Echo ash abstract in relapse refractory CLO I'm curious to get your thoughts and what the appropriate benchmarks are in this late line CLO setting out what kind of data, which you need in.

Unknown Executive: Maybe a bit more color on 1042 units. Yeah, thank you. Thank you. So, as you said, we have two confirmed PRs, one in melanoma and one in lung cancer, 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 has 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-events curve, not so much on ORR.

In this later line study to support development in earlier lines CLO setting.

Thanks, Jonathan for the question I will hand, it over to you that maybe you are as you can get some perspective on benchmarks for the very heavily pre treated CLO operation of its fee included in the first.

The <unk> study.

Yes. Thank you for the question so it depends not only on the prior length of stay that be bad day categories of Asia that <unk>.

God and.

Whether they exhaustive PTK inhibitors.

And then click on.

So the population that we enrolled was heavily predictive data and.

Unknown Executive: So we are excited because, you know, given the patient population and given the CD40 target plus for 1 dB, we really expected limited activity in terms of tumor shrinkage. But, you know, the DCR, disease control rate, is relevant in this tumor population. Yeah, and I don't know if there were more questions when I was disconnected. I'm sorry again.

Most of them got be Teekay, maybe doors and part of them or most of them have a very bad biological prognostic characteristics.

<unk> 17 dilution.

The bar is.

No.

Unfortunately for those Olson.

Get some level of Donaldson and do that.

So it's not a single factor.

All right.

Very good then app, because they're down that road.

It is.

Unknown Executive: There's one more question on 1046. We basically have good data and LungData, which will be described, of course, at FITC. And the question is, well, did we also see data in other cancers to drive our enthusiasm, or is this a lung cancer-only type of program? Yeah, so we, you will see more data in the poster soon, which is on November 12th, but just what we did in phase one with expulsion was to learn about the biology of this asset, which is so novel, particularly for 1BB, to guide us to the next step. And the totality of the data, including in other tumor types, speak to the same fact that we have seen in non-small cell lung cancer.

And lets call on US is durability of response and pointed out of anything.

Thank you.

Thanks, Thanks, Jonathan.

Got it to the next year the next question.

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

Hey, guys. Thanks for taking my questions I have two questions. Another one on 10 46, I think I heard you say that you're planning a phase two study in combination with <unk>.

Relapsed refractory non small cell lung cancer patients I'm trying to understand the rationale given that 5%.

<unk> antibody.

Probably already blocks the PD one interaction I'm just curious how much added our synergistic efficacy one would expect there and why.

And then the second question was on <unk> I know you have the R. Chop combo phase one data at Ash.

Unknown Executive: So, the totality of the data is robust enough to guide us on next steps, lung and not lung. Thank you Judith and James. 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 Keenan McKay from RBC. Please go ahead. Hi, thanks for taking the question and congrats on the commercial progress here. Maybe two questions, if I may as well.

Curious, how you think the Roche collaboration.

Thought may potentially affect your plans to move ampco into first line <unk> down the road. Thanks, so much.

Thanks, Michael for the questions I think I'll hand them over to unit and then see what I call that I can add further perspective, there may be units you can address both the 10 46 question in the Opco R. Chop question.

Unknown Executive: For Judith, relating to Gen 1046, 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 a Goldilocks drug where just

Yes. Thank you so let's start with Sam for D. C. As you have seen in the abstract are very important biological observations. So in 2006 basin that had tumor samples to Fas PDL one presents.

Unknown Executive: is treating to the absolute maximum tolerable dose.

Does that word PDL one policy team.

Unknown Executive: [inaudible] Thanks, Canon. And I will let Judith think about the 1046 question.

We're only pan tumor samples from 10 patients.

And then have it tumor shrinkage.

Unknown Executive: So I can tell you that we are rigorous in our decision-making, Canon, as it relates to the pipeline. And we stopped two programs, as I said in my introductory remarks, the DR5 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 new Hexabody CD37 program. And we will probably come with a short update this year and then more data, Canon, next year when we can show the whole dose escalation data.

On the converts.

16 patients electro more samples belonging to patients that were PD lone negative.

Most of them like 12 out of 16 had any no tumor shrinkage. So the ies clear association between PDL, one brands vans and the activity of this compound. We also show in the PK PD model that the receptor occupancy.

For PDL, one is not optimal we achieved 100% so with PDL 141, BB because I've said before that dose was selected to optimize their linguistic effect, we need PDL one.

Unknown Executive: And also, the Hexabody CD38 program is of very, very high interest and is moving ahead nicely. Also, this year, you will get a 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 at least two, perhaps even more products, new products into the clinical pipeline in the new year, in 2022.

70% without inhibition and we know from other PD, one PDL one inhibitors in the market that for them to be fully actively you need like 100% receptor occupancy DS plus the fact that as we show in the abstract.

Activity.

What we sell in the expansion is much more high yet so dose patients that were treated with a PD one PDL one maybe in the last eight months and the receptor occupancy is still there than the patients that didn't.

Unknown Executive: So 2022 will be a very exciting year for the company. I think not only with the potential filing for EPCO, the initial filing for EPCO, but also with hopefully moving one or two programs to late stage clinical development. And that can also include programs like 1042, 1046, which are now on the radar screen, basically, of everybody.

It makes it gives us day in a classroom that combining with a PD. One inhibitor is that right next step to optimize the potential benefit of 10 46.

That may be the <unk> question.

<unk>.

The impact of the <unk> T cell lymphoma hotline to Solomon studies units.

Yes. Thank you. So we will hear more details on the pillar data at ash.

Unknown Executive: So we are very excited about the pipeline, Canon. I think it has never been a stronger pipeline than it is right now. But we will continuously have to weed through and identify the real winners, potential winners, and then stop the other programs because I think focus is very important. That has brought GenMob to where we are right now, focusing on the right molecules, on the right technology, and the right technologies to create differentiated antibody medicines. And I think we're getting better and better at that.

We only hear what everybody knows like the high level results and based on the actual data and we will assess where they're expanding more our clinical development plan or amending is necessary and we will act accordingly, but we are waiting for four more.

For more resolve it to understand how this could impact our clinical development plan.

Thanks, Thanks, David Thanks, Michael.

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

Hi, Matt Thanks for taking my questions I've got a couple of long term 42, and <unk> 46, if I may ask 1042, yes, I think the introduction, Michigan, a bunch of combination studies with Keytruda.

Street, a chemo combination.

If I heard you correctly it along its a bit tough so I just wondered what combination data you have.

Unknown Executive: 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, Canon, on molecules that can be transformational. We believe that EpcoRitmop will be transformational for B-cell cancers.

14 of these combination studies versus the mono data we've seen in the abstract the.

The second question is you very clearly commented on that.

And why we should focus on the disease control rate I Wonder if you could comment on the second aspect of it that's been investor folks, which is the one great for live events.

And how you think about that.

Any further data you've got on liver tox.

The second question was on 10 46, you referenced further development partner bond to accept that the phase II study was going to start in four key 22 next year. So I'm just wondering what's taking so long for that study start.

Unknown Executive: I think the data will show that, which you will hopefully also see, again, reconfirmed at ASH. And we are now putting a very large military machine, the Epfi, 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 choice of the doses for 1046 units. Yes, thank you, Jan. And we are presenting a poster at CITSI as well on a semi-mechanistic PK-PD model where we put a lot of preclinical and clinical data into it because, as you alluded to, there is this Goldilocks effect or bell-shaped curve that allowed us to choose the dose of 100 milligrams as it's the perfect dose for trimer formation.

And then a clarification question on what's coming in.

<unk> continue to sanction that we will be getting updated long data and updated data on other cohorts rather than just market response in lung as we've shown in the abstract so I just wanted to clarify that thank you.

Thanks session. So 10 42, <unk> six a very popular for sure that keeps I think units quite busy so ill handle both questions to you then and feedback on at.

After 10 42 in the Combi data what evidence we have pre clinically I think is probably the right angle here.

Yes. So thank you again Etienne said I mean, we have a very compelling preclinical data of <unk>.

Synergy at TVT of them 42 glass.

Unknown Executive: That means the trimer between PD-L1, device-specific, and for 1 dB. And this is why it was chosen. And interestingly enough, when we fed the model, even with translational data, everything was very, very strong that 100 milligrams is the dose where we optimized the primer formation and the agonistic effect for 1 BB. So we are very confident with the dose that was selected based on multiple data points that we put in

I'm going to use a map.

And we.

The cohort of a combination of 10 42, plus and Murdo are in <unk>.

Clinical trial 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 the coming months moving nicely.

So this is for 10 40 to the other question on <unk>, then you guys talked or the stocks in general in General has been 42 is very well tolerated with.

Most of them.

Safety events grade one grade two we have seen a 10% increase in 10% of the patients in traditional ASD elevation.

Unknown Executive: Thanks, Judith. Hopefully, Canon, that is okay for you. Otherwise, you will get back to us separately on a call. Operator, maybe we can move to the next question. The next question comes from the line of Jonathan Chang from SVB Liring. Please go ahead.

<unk> city or above only a 6% then means to patients. So we are following but so far it seems manageable and.

<unk>.

Yeah.

Unknown Executive: Hi guys, thanks for taking my questions and congrats on all the progress. First question, on the EPCO-ASH abstract and relapse 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 settings?

What we can see there.

Well tolerated even at a very.

Well tolerated range. So this is for 10 42.

Any other question anytime 40 sort of family.

No I think you can move to 10 46, and the timing of the phase III I think that caused some confusion I think.

I think caused bye bye.

<unk> set to biotech.

So we are expecting to finalize them at randomized phase two to SaaS.

Sure.

Data so we have some expansions ongoing.

Unknown Executive: Thanks, Jonathan, for the question. I will hand it over to Judith.

In different combinations or in different settings that will guide as of the next steps on that randomized phase two so everything you suddenly inc. So we are waiting for data sets coming from the cat plant expansions to guide us on the activation on the vancomycin.

Unknown Executive: Maybe, Judith, you can give some perspective on benchmarks for the very heavily pre-treated CLL population, which we included in the first EPCO study. Yes, 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 exhausted BTK inhibitors and Benclexta or not. So the population that we enrolled was heavily pre-treated, and most of them got BTK inhibitors, and furthermore, most of them had very bad biological prognostic characteristics at 17p dilution. So there, the bar is low, unfortunately, for those patients. So it's getting some level of remission, and the durability is important as well. So it's not just a single factor.

This tool, which will occur next year.

Thanks, Thanks, our units and then maybe some comments on this on the data from other cancel spit in 10 46 at <unk>.

Maybe a bit on what type of data basically yeah. So thank you and I alluded to that before.

We did.

The data that you will find in the post there is.

Lined in Dallas plenty to more align with their biological signals that we found for non small cell lung cancer in terms of the PDL one expression.

And in terms of finding their biological rationale to value that on next steps. So these include non small cell lung cancer and other tumor types.

Unknown Executive: As you know, these patients are very beaten up because they are down the road, so it's a response, it's durability of response and tolerance. Thank you, Yaron. Thank you.

Very good well I'll, just say what can I say.

One follow on the 10 42, Pembroke combo dates you referenced is coming in the next months.

Could you be more specific on that just chance myeloma. Thank you.

Oh, yes.

Unknown Executive: Got it. Thank you. Next question. 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.

Yes can you hear me.

Yes, yes, yes, okay. So.

We amended the protocol and as they did in clinical trial Gov that we add the cohort of combinations with <unk>.

In the head and neck in non small cell lung cancer and in melanoma. So those data will guide us on the next season.

Unknown Executive: Another one on 1046. I think I heard you say that you're planning a phase two study in combination with PEMBRO in relapsed refractory non-small cell lung cancer patients. I'm trying to understand the rationale given that the bi-specific 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.

We expect to have these data in the next months.

Thanks for that.

These cohorts are recruiting very quickly session. So so the.

I think that is a reflection of our enthusiastic doctors are about 10, 42, as well, but I think more to come at <unk> and certainly more to come next year.

Thank you.

Unknown Executive: And then the second question was on EPCO-RITMAP. I know you have the RCHOP combo phase one data at ASH. I'm just curious how the Roche-Polaris result may potentially affect your plans to move EPCO into a first-line DLBCR down the road. Thanks so much.

Thanks session.

The next question yes.

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

Thank you can I ask a question. Please so obviously a key element of the guidance raise for this year was the change in the cadence of spending I am very interested in how the change in cadence of spending is then going to run into 2022.

Unknown Executive: Thanks Michael for the questions. I think I will hand them over to Judith and then see what I can do to add further perspective there. Maybe Judith can address both the 1046 question and the APCO art shop question. Yes, thank you. So let's start with 1046.

Outlined a raft of new trials, which are starting to do that.

You have a lot of commercial opportunity in terms of setting the scene for your royalty portfolio and the launch so any comment on how we should anticipate the cadence of cost going into 'twenty two would be very helpful. Thank you. Okay. Thanks, Matt for the question I will hand, it over to Anthony Bonanno is you know you will we will give guidance in February next year that Nathan.

Unknown Executive: As you have seen in the abstract, there are very important biological observations. So, in 26 patients that had tumor samples to assess PD-L1 presence, those that were PD-L1 positive, which were only 10 tumor samples from 10 patients, 7 had a tumor shrinkage. On the converse, you know, 16 patients or tumor samples belonging to patients that were PD-L1 negative, most of them, like 12 out of 16, had no tumor shrinkage So there is a clear association between PD-L1 presence and the activity of this compound.

Anthony can provide a bit more color for you Matt.

So Anthony please go ahead.

Yeah. Thanks, Thanks, Scott Thanks.

First of all Youre 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 and our revised guidance in the range of five three years to $5 6 million in Opex.

As you're kind of pointing out is really the timing of our investments for certain R&D activities and overall organizational capability expect capability build 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 in line with our overall strategy and our key priorities and we will continue to be focused and disciplined as we move forward and as a reminder, in Jan alluded to this on for Echo together with Abbvie. We are planning to start a number of late stage trials in the coming in the coming quarters.

Unknown Executive: We also showed in the PK-PD model that the receptor occupancy for PD-L1 is not optimal, which is 100%. So with PD-L1 for 1BD, because, as I said before, the dose was selected to optimize the agonistic effect, we leave PD-L1 30% without inhibition. And we know from other PD-L1 inhibitors in the market that for them to be fully active, you need about 100% receptor occupancy. This plus the fact that, as we show in the abstract, the activity we saw in the expansion is much higher for those patients that were treated with a PD-L1 inhibitor in the last eight months, and the receptor occupancy is still there, than those that didn't.

On SG&A our focus in the short term is really on the launch of <unk> and also preparing for potential <unk> launch and it is important to highlight that this will also entail it's ready to potentially up to launch that this will also entail additional investments in building the commercialization.

Restructure and prelaunch activities. So overall the revised 2001.

The guidance on FX Opex, primarily reflects shift or phasing. So I think Matt. The key takeaways is that look we are a wonderful business solid set of technologies exciting pipeline and we're evolving to become this fully integrated biotech we're starting off with Tim that we're super excited about the opportunity there, but more moving forward we are all.

That will be Super focused on <unk> as we move forward both from a development as well as a.

Commercial commercialization readiness perspective.

Tom in terms of our exact.

<unk> planned activities in our guidance ultimately here for 2022, as we move forward, particularly around our 'twenty one our earnings release in February.

Unknown Executive: It gives us the rationale that combining with a PD-L1 inhibitor is the right next step to optimize the potential benefit of TEMP46. That may be the APCO question. Well, how will the polarity impact or the few stars sell from a frontline development strategy unit? Yes, thank you. So we will hear more details on the Polarix data at ASH. But we only hear what everybody knows, like the high-level results

Thanks, Anthony Thanks, Matt for the question.

Thank you.

Let's move to the next one operator.

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

Hi, Thanks, Yeah, I've got just two left firstly just on 10 42, what if you could just talk a little bit about the selection of the dose for that molecule you talked a bit about 10, 46% 42, but you're also looking to optimize trying inflammation and also the agonistic sites before BP or are there other factors to bear in mind for this year.

Unknown Executive: And based on the actual data, we will assess whether expanding or amending our clinical development plan is necessary, and we will react accordingly. So we are waiting for more results to understand how this could impact our clinical development plan. Thank you. Thanks, Michael. And the next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

Talk a little bit about how you got to be the recommended phase two dose expansion cohorts.

And then secondly, just because of the J&J deal bodies.

Might just be an admission and for simplicity sake, but if it looks is that according to your pipeline chart.

Although that particularly.

Two questions.

So with the other programs like BCD three one.

Unknown Executive: Hi there, thanks for taking my questions; I've got a couple on 10.42 and 10.46, if I may.

<unk> 333 P SMA.

Now it makes it but already the clinic is that just for simplicity or has J&J decided to focus as Stuart body collaboration now on to <unk> question.

Unknown Executive: I think you get the introduction list of a bunch of combination studies with kids.

Thank you.

Unknown Executive: Petruda or Petruda chemo combination. If I heard you correctly, the line was a bit tough.

Thanks, Thanks, Peter So so I'll handle both questions actually two units to units and then see where I can add on the on the J&J question. You did maybe on 10 42, a bit more color on the dose selection in the dose finding.

Unknown Executive: So I just wondered what combination data you have that is supporting those combination studies versus the mono data we've seen in the abstract. The second question is: you very clearly commented on the ORR and, you know, why we should focus on the disease control rate. I wonder if you'd comment on the second aspect that has been investor-focused, which is the Grade 1 liver event, and how you think about that, and any further data you've got on liver tox there. The second question was on 1046.

Yes. Thank you so in case of <unk> 44, when DB, both agonistic targets and both have what we call. The goldilocks effect. So we do have a very short OSA.

Based on peak <unk> and the buildup of one eight milligrams is the dose that and.

Optimize the three mile formations for both asset for both targets for the on photo MBV. So we are very confident that this is the dose. This is why we didn't even escalate at MTV and because we had that the optimal biological dose at 190.

Unknown Executive: You referenced further development. I think your partner, Biontech, said that the phase 2 study was going to start in 4Q2.

So we feel very confident with the dose.

The second question was to get to.

Unknown Executive: So I'm just wondering what's taking so long for that study to start. And then I had a clarification question on what's coming at SITC. It seemed 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 the lung, as we saw in the abstract. So I just wanted to clarify that. Thank you.

J&J duopoly platform.

Just a question on other assets.

Secondly, they are Stefan Stefan basically in the clinic and Peter asked well why are we focusing on these long term optically spinoff consolidator model of other multi autos basically.

Yeah, I mean, what we know is what is in the public domain and the asset that have a date that on the public domain, who makes us excited about.

For sure.

Particularly some of them can't get them up so the others at.

Leon and days now too much.

Unknown Executive: 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 see where I can add. Maybe start with 1042 and the COMBI data; what evidence we have preclinically, I think, is probably the right angle here. Yeah, so thank you, Jan. As Jan said, I mean, we have very compelling preclinical data of the synergy additivity of 1042 plus pembrolizumab.

In the public domain for us to be excited about.

Exactly pizza so they are still in the clinical development some of them.

Post recruiting auto Saar basically recruiting as we understand it that we actually decided to focus on the more interesting exciting ones.

Moving in to Phase III.

Christa.

We're already on the market like bumped them up and also in phase III and to create them up is taking a lot of enthusiasm right now it's in phase two and probably also move to further.

The lines of clinical development soon and then there is still I think potential for one or two of the autos Peter to also move forward, but we decided to put less emphasis on that.

That's great. Thank you.

Unknown Executive: And we, the cohorts of a combination of 1042 plus Temuro, are in clinicaltrial.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 the coming months. So it's moving nicely.

Thank you.

Operator, maybe we can move to the next question yes.

Yes. Our last question comes from the line of <unk> <unk> from <unk> Securities. Please go ahead.

Hey, guys. Thanks for taking my question.

I'd like to start off we went to Munich and Gen $10 40 to 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 Gen <unk>.

Unknown Executive: So this is for 1042. The other question on 1042 was delivered talks or the talks in general. In general, 1042 is very well tolerated with most of the safety events, grade one or grade two. We have seen 10% increase in 10% of the patient's increase of ASTLT elevation, a grade three or above only 6%.

Will you be looking 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, Oscar for the question unit I think I will keep you busy today. So this will vote for you.

So thank you for the question.

<unk> that Jim then 42, it should be developed in combination.

Because if the biology of city for the Alpha one DB and DC why we started with a combination of neon and as I said, we had already.

Unknown Executive: That means two patients. So we are following, but so far, it seems manageable, and the percentages are what we consider very well-tolerated, in a very well-tolerated range. So this is for 1042. Any other questions on 42 family things? No, I think you can move to 1046.

Link down 42, plus <unk> and there are two other cohorts in Clinicaltrials Gov in combination with chemo plus minus turmoil. So it's clearly.

The biology of this compound needs something else and this is we are adding to.

Unknown Executive: And the timing of phase two, I think that caused some confusion, I think, I think caused by our friends at BioNTech. So, we are expecting to finalize the randomized phase 2 to assess more data. So, we have some expansions ongoing in different combinations or in different settings that will guide us on the next steps in randomized phase 2. So, everything is linked. So, we are waiting for data sets coming from the current expansion to guide us on the activation of randomized phase two, which will occur next.

The combination then.

Your second question is he is a great question and one of the cohorts in time for Q2.

<unk> in melanoma cohort with a very heavy translational research component part of it is paired biopsies that will allow us to understand in depth.

Hey, Dan.

Infiltration of the tumor with lymphocytes and other pharmacodynamic markers of activity, which had really relevant because of the novelty of the target and actually putting the posted on zinc.

The abstract and then you wouldn't see motivate them.

In the phase one we were able to modulate <unk> toric, which is very important because that means that we are this compound is really targeting CD 40 on activated dendritic cells, which is what we want from them 42, so more to come as we gather more data, but they buy your lunch.

Unknown Executive: Thanks. Thanks, Judith. And then maybe some comments on data from other cancers in 1046 at SID-C, maybe a bit on what type of data, basically. So, thank you. And I alluded to that before. The data that you will find in the poster is aligned with the biological signals that we found for non-small cell lung cancer in terms of PD-L1 expression and in terms of finding the biological rationale to guide us on next steps. So this includes non-small cell lung cancer and other small tumors. Very clear. Can I just take one follow on the 1042 Pembroke combo data you referenced is coming out the next month?

Rationale I'm framing is behind the compound is being.

As shown in the phase one.

With the Pharmacodynamic markers and we are including these in depth and Youll see more in the poster.

Thanks, Jessica any follow on.

Yes, Ron.

I think Randy.

Around this time last year.

When asked the question what are your top priorities for <unk>.

The top three priorities for 2021, I think in particular at 10, 610, <unk> and <unk>. We asked that same question between between thing to what we can say.

Unknown Executive: Could you be more specific on that? Just chance my arm there. Thank you.

Unknown Executive: Oh, yeah. Judith? Yeah, thank you. So, yes, can you hear me?

Yes. This is still the top III priority Statoil as actually a number of <unk> to that so the company I think.

Unknown Executive: Yes, yes. Okay, so we amended the protocol, and it's updated in clinicaltrial.gov, adding cohorts of combinations with pembrolizumab in head and neck, non-small cell lung cancer, and melanoma. So those data sets will guide us on next decisions, and we expect to have this data next month. Thanks, Judith. So these schools are recruiting very quickly here, Sachin, so I think that is a reflection of how enthusiastic doctors are about 1042 as well. But I think there will be more to come at SIDS-V and then certainly more to come next year. Thank you. Thanks Sachin. Maybe the next question?

Bravo and I think also.

I think increasingly professionally organized so I think we will actually broaden our pipeline ustica.

As already alluded to in an earlier question is we are 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 top priorities ustica, probably at CD 3700, 38 to those priorities for 'twenty two.

Great. Thanks for taking my questions guys.

Thank you. Thank you that's all.

Operator are there any further questions.

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

Alright, so thank you for calling in today to discuss general financial results for the first nine months of 2021, if you have any additional questions. So it's 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.

Unknown Executive: 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...

Unknown Executive: In The Cadence of Spending, I'm very interested in how...

Unknown Executive: [inaudible]

Unknown Executive: Yifeng Liu, Yifeng Liu, Yifeng Liu

This.

The conference call. Thank you all for attending you may now disconnect your lines.

Unknown Executive: you should anticipate the cadence.

Thank you.

Okay.

[music].

Unknown Executive: [inaudible]

Unknown Executive: Thanks, Matt, for the question. I will hand it over to Anthony Pagano.

Okay.

[music].

Okay.

Okay.

[music].

Unknown Executive: As you know, we will give guidance in February next year, but maybe we can see whether Anthony can provide a bit more color for you, Matt. So Anthony, please go ahead. Yeah, thanks. Thanks, John. Thanks, Matt. First of all, you're right.

Okay.

[music].

Unknown Executive: With the expense run rate for the first nine months, costs were a bit on the low side relative to our previous four-year guidance. So our revised guidance in the range of 5.3 to 5.6 million in OPEX, you know, as you're kind of pointing out, is due really to the timing of our investments in certain R&D activities and our overall organizational capability build. The R&D expenses were really impacted around the phasing of costs related to various pipeline programs.

Yes.

Yeah.

[music].

Okay.

Okay.

[music].

Yes.

Okay.

Okay.

Okay.

[music].

Yes.

Unknown Executive: 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 in line with our overall strategy and our key priorities and will continue to be focused on disciplines as we move forward. As a reminder, and Jan alluded to this, for EPCO, together with ADVI, we are planning to start a number of late-stage trials in the coming quarters.

[music].

[music].

Okay.

Yes.

Okay.

[music].

Yes.

Okay.

Unknown Executive: On SG&A, our focus in the short term is really on the launch of TIVDAC and also preparing for potential EPTO launch. And it's important here to highlight that this will also entail, as related to potential EPTO launch, that 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, you know, shift or phasing. So I think, Matt, the key takeaways is that look, we have a wonderful business, a solid set of technologies, an exciting pipeline, and we're evolving to become this fully integrated biotech.

[music].

Okay.

Okay.

[music].

Unknown Executive: We're starting off with TIVDAC. We're super excited about the opportunity there. But, you know, moving forward, we have all eyes on EPTO as we move forward, both from a development perspective as well as a commercialization readiness perspective.

Yeah.

[music].

Yes.

Yes.

[music].

Unknown Executive: 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 earnings released in February. Thanks, Anthony. Thanks, Matt, for the question. Thank you. Let's move to the next one, operator. The next question comes from the line of Peter Welford from Jefferies; please go ahead. Hi, thanks. Yeah, I've got just two left. Firstly, just on 1042, just talk a little bit about the selection of the dose for that molecule. You talked a bit about 742, are you also thinking of the other factors to bear in mind for this you took a little bit, And then secondly, just in regards to the J&J duo. It might just be an omission, in fact. It looks as though, according to your pipeline chart, it as though

Okay.

[music].

Yes.

Okay.

Yes.

Yes.

Yes.

[music].

Unknown Executive: Other than Teclista and Tecuetamine,

Unknown Executive: Some of the other programs, like CD3, 123, CD33, PSMA, are now omitted but are in the clinic. Is that just simplicity, or has J&J decided to focus on its dual body collaboration?

Unknown Executive: Collaboration now on the CliftonMap and CliftonQuestionMap in the remaining days. Thanks. Thanks, Peter. So.

Unknown Executive: Thanks, Peter. So I hand over 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. Yes, thank you.

Okay.

Unknown Executive: So in the case of CD40 and 4.1BB, both are agonistic targets, and both have what we call the Goldilocks effect. So we did a very thorough assessment based on PKTD, and the dose of 100 milligrams is the dose that optimizes the tremor formation for both targets. So we are very confident that this is the dose. This is why we didn't even escalate to MTD because we had the optimal biological dose at 100 milligrams.

Sure.

[music].

Yeah.

[music].

Unknown Executive: So we feel very confident with the dose. The second question was with regard to the J&J dual body platform. This was a question about other assets.

Okay.

[music].

Unknown Executive: They have seven, basically in the clinic. And Peter asked, well, why are we focusing on Army Phantom Op, the Callisto Op, and Talqueta Op? What about the others, basically? Yeah, I mean, what we know is what is in the public domain, and the assets that have data in the public domain, which makes us excited about for sure. So the others are early on, and there is not too much in the public domain for us to be excited about.

Okay.

Yes.

Yes.

Sure.

Okay.

[music].

Yes.

Okay.

Yes.

Yeah.

[music].

Unknown Executive: So they are still in clinical development. Some of them are post-recruiting, others are basically recruiting, as we understand it, but we actually decided to focus on the more interesting, exciting ones. They are either moving into Phase 3, like the Callisto map, or already on the market, like Amoebanta map, and also in Phase 3. And Tolkieta map is triggering a lot of enthusiasm right now.

Okay.

[music].

Okay.

Okay.

[music].

Okay.

Hum.

Okay.

[music].

Unknown Executive: It's in Phase 2, and probably will move to further lines of clinical development soon. And then there's 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. Thank you. Operator, maybe we can move to the next question. Yes, our last question comes from the line of Asthika Goonewardene from Troy Securities. Please go ahead. Hey guys, thanks for taking my questions. I'd like to start off, we want to do this on Gen 1042. There is a two part question here. Is there any rationale for this drug in the monotherapy setting?

Okay.

[music].

Thank you.

Okay.

Yes.

Yes.

[music].

Yes.

Yes.

Okay.

Yes.

Okay.

Okay.

Yes.

[music].

Yes.

Okay.

Okay.

Yes.

Yes.

[music].

Okay.

[music].

Okay.

Okay.

Unknown Executive: Or is this largely going to be a combination? And then also Gen 1042, will you be looking at serial biopsies? And what do you expect to see in terms of T cell infiltration into the tumor microenvironment? And I have got a couple of follow-up questions. Thanks, Asthika, for the questions. And Judith, I think I will keep you busy today.

Unknown Executive: So this will be both for you. Thank you for the question. We think that Gen 1042 should be developed in combination because of the biology of CD40 and 41BB. So this is why, you know, we started the combinations early on.

Okay.

Yeah.

[music].

Okay.

Unknown Executive: And as I said, you know, we are already enrolling 1042 plus PEMBRO, and there are two other cohorts in clinicaltrials.gov in combination with chemo plus minus PEMBRO. So clearly, the biology of these compounds needs something else, and this is what we are adding to. This is the combination.

[music].

Sure.

Yes.

Okay.

Okay.

Okay.

Unknown Executive: 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 infiltration 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 on the poster and put in the abstract, and you will see more data, in phase one, we were able to modulate a TARC, which is very important because that means that we are...

[music].

Okay.

Okay.

[music].

Unknown Executive: 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, but the biological rationale and premise behind the compound are being shown in phase one, and with the pharmacodynamic markers, and we are including these in the abstract, and you will see more in the poster.

Okay.

Okay.

[music].

Okay.

Yeah.

Okay.

[music].

Unknown Executive: Thanks. Thanks, Judith. Asthika, any follow-up? Yes, Jan, I think around this time last year, you were 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 you the same question for 2022, what would you say? Yeah, these are still the top three priorities, but we'll add actually a number of others to that. So the company gets, I think, broader and, I think also, increasingly professionally organized.

Okay.

Okay.

[music].

Okay.

[music].

Sure.

[music].

Unknown Executive: I think we will actually broaden our pipeline, Asthika, and as I already alluded to in an earlier question, we are very excited about some of the early stage clinical programs. We believe that some of them have the potential to move to the late stage.

Yes.

[music].

Unknown Executive: So we will still keep these three as our top priorities, Asthika, but we'll probably add CD37 and CD38 to those priorities for 2022. Great, thanks for taking my question, guys. Thank you. Thank you to that operator. Are there any further questions? 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 that 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. Thank you all for attending; you may now disconnect. Thank you.

Okay.

[music].

Yes.

Hum.

Yeah.

[music].

Okay.

[music].

Hum.

Tom.

[music].

Unknown Executive: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??

Yeah.