Immunocore Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 28, 2024

There are 18 speakers on the call.

Operator

Greetings. Welcome to the Immunacor 4th Quarter Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded.

Operator

I will now turn the conference over to Clayton Robertson, Head of Investor Relations. Thank you. You may begin.

Speaker 1

Thank you, Daryl. Welcome everyone to our Q4 and full year 2023 financial results call.

Speaker 2

Before we begin, I would

Speaker 1

like to remind you that this call will contain forward looking statements within the meaning of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. These include expectations and plans concerning future events, prospects and performance, including with respect to commercialization, clinical development and trials, regulatory approvals and financial results. Actual events may differ materially from those indicated by these forward looking statements as a result of various important factors, including those disclosed in our filings with the SEC. And such statements represent our views only as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

Speaker 1

With that, I'm now pleased to introduce ImmunoCare's CEO, Doctor. Puneja Jalal.

Speaker 3

Thank you, Clay. Hello, everyone. With me today are Ralph Torbay, our Head of Commercial David Berman, our Head of R and D and Brian DiDonato, our Chief Financial Officer. We will be happy to take your questions at the end. At ImmunoCore, we are driven by a clear mission to bring transformative immunomodulating medicines to patients.

Speaker 3

In 2023, we continue to advance our 3 strategic pillars of maximizing the potential of KimTrak, advancing our clinical portfolio and continuing to innovate for sustainable growth. Let's look at the first one. On KimTrak, last year, we achieved $239,000,000 in net KimTrak sales. Going into 2024, we see 3 growth opportunities. 1st, continuous commercial growth driven by the U.

Speaker 3

S. 2nd, mid term growth driven by Q4 data from Tebbi AM trial and third, long term growth with the ATOM trial expected to start recruiting this year. The second pillar on the portfolio. We continue to advance our clinical portfolio with the announcement of our first PRAME Phase III trial in first line advanced cutaneous melanoma. We intend to randomize the first patient in Q1.

Speaker 3

PRAME clinical data updates in melanoma, ovarian and lungs will come throughout 2024. Reflecting our enthusiasm for the PRAME targets, we are advancing 2 new candidates into the clinic this year. In December, we submitted the CTA for our 1st in class candidate targeting PWEL in colorectal and GI cancers. And we continue to pursue a potential functional cure in HIV with Phase 1 data for the first half or second half of twenty twenty four. The 3rd pillar is in innovation.

Speaker 3

And last month, we announced that we had added 2 novel tissue targeted autoimmune programs, 1 for type 1 diabetes and the second for dermatology indications. You will hear more about each of these exciting programs from David. These additions expand the therapeutic areas we aim to treat to 3. And now I'm happy to hand over to Ralf to share more information about FINTRAC. Ralf?

Speaker 2

Thank you, Dheja. Hello, everyone. 2023 was a catalyst year for KimTrak. In less than 2 years from our first approval, we have transformed medical practice in metastatic uveal myeloma and established this pioneering PCR medicine as the first line standard of care across all launch markets. We have treated over 2,000 patients globally since the start of our first clinical trial and I'm very proud of this team's achievements and commitment to patients.

Speaker 2

Kymtruck is currently approved in 38 countries and launched and reimbursed in 12. With the publication of KymTract's long term 3 year overall survival in the New England Journal of Medicine, we continue to raise the bar of survival and I look forward to the impact the team will have in 2024 leveraging this data. I will now take you through the figures and financial performance in more detail. For the full year 2023, Himtra generated $238,700,000 in net revenues, which represents a 70% year on year growth. In the 4th quarter, we reported $67,600,000 in net revenues, which represents an 8% increase from the prior quarter.

Speaker 2

This growth was primarily driven by continued commercial progress in the United States. In Europe, we launched in 6 new countries and reached pricing agreements with Italy and Germany. In France, we have been recognizing revenue since day 1 and have been accruing for an expected negotiated price. In the international region, we signed pricing agreements with Canada and Australia, which we are launching through the first half of the year. Our goal in 2024 is to continue our growth momentum in the United States and reach more patients globally, including our next country, Spain.

Speaker 2

We're also excited to potentially expand the benefit of KimTrak to additional indications with our clinical program, which I will take you through in the next slide. We believe KymTruck has significant potential for additional growth in the medium and long term, driven by 2 registrational clinical trials. The TEB AAM study builds on the chemTRK Phase III cutaneous melanoma data that has shown a 76% survival rate at 1 year with an acceptable safety profile. Enrollment is going well and we expect top line results from the Phase 2 portion in the Q4 of this year. All the evidence with KimTrak points to our platform being potentially transformative in the early disease settings.

Speaker 2

We were honored to work with EORTC to launch the only ongoing registrational adjuvant study in uveal melanoma, the ATOM trial. We anticipate randomization to start in the second half of this year. Now let's bring it all together in the next slide, please. Today, we're only at the beginning of the KimTrak journey where the benefit is focused on etavulin patients with metastatic uveal myeloma. With the TEVI AM trial, we see the potential to help 2,000 to 4000 additional patients with second line plus metastatic cutaneous melanoma.

Speaker 2

With the ATOM trial, we could be unlocking the early stage uveal melanoma potential and bringing the benefit of KimTrak to up to 6,000 patients across all three indications. On a personal note, I am excited about our future because of this past year. I had the privilege to meet one of the first patients in our clinical trial, a parent of 4 that has been taking chemtrax for 7 years and is doing well. I also met our first patient in our early access program who remains well and on treatment and a physician who expanded their practice to handle the volume of patients who are now surviving. These people remind us every day of why we need to persevere in helping patients and advancing the science.

Speaker 2

I'll now hand it over to David to talk more about our pipeline.

Speaker 4

Thank you, Ralph. I'm happy to share an update on our clinical stage portfolio and let's start with PRAME. Our PRAME opportunity stands across multiple solid tumors, including melanoma, ovarian, lung and endometrial carcinoma. By the end of this year, our franchise will include 3 clinical programs targeting PRAME, including a program for HLA AO2 with a half life extension and a program for patients who are HLA A24 positive. Today, I will focus on the lead program F106C.

Speaker 4

Across the 4 major tumor types we are studying with F106C, the melanoma data matured first and provided confidence to launch the Phase 3 PRISM MEL-three zero one. We will share the melanoma monotherapy and anti PD-one combination data in Q2. After melanoma, the ovarian monotherapy and chemotherapy combinations have been maturing and we are on track to share this data by 3rd quarter. For lung, we are currently enrolling monotherapy and combinations. Unlike ovarian and melanoma where we enrolled all comers, for lung we have focused on select subsets where we would expect to see initial signals before expanding more broadly.

Speaker 4

This data will continue to mature in first half and will be shared by Q4. Additional exploration continues, including endometrial, contract combinations and dose confirmation. Several data points led to the initiation of the Phase 3 trial in first line melanoma, including F106C monotherapy activity in heavily pretreated patients, the ability to combine with anti PD-one and insights that our platform works best in early stage disease. We have opened clinical sites for the Phase 3 trial and expect to start randomizing patients in the near future. We are pleased to have a clinical trial collaboration and nivolumab supply agreement with BMS for this trial.

Speaker 4

I will now turn to highlight the power of our target discovery engine with a novel first in class target against PWEL-one. R117C is the 1st immunotherapy to target PWL-one, a protein which is expressed in colorectal carcinoma, a tumor that has historically been insensitive to checkpoints. PWOL is an attractive target since it is not expressed in normal vital tissues, is a negative prognostic marker and has broad expression in about a quarter of colorectal cancer patients. The CTA in Europe was submitted in December of last year and we are on track to start the trial by the second half of this year. Turning now from oncology to HIV.

Speaker 4

In addition to redirecting T cells to kill cancer cells, we believe our technology can be used to redirect T cells to kill virally infected cells. For HIV, the current standards of care of antiretroviral therapy block replication that cannot eliminate the virus, which hides it as a reservoir in CD4 T cells. In the single ascending dose portion of the M113V trial, we demonstrated safety and biomarkers indicating target engagement. The goals of the ongoing multiple ascending dose ascending dose portion are to demonstrate antiviral activity including 1, reducing the reservoir in blood and 2, delaying the viral rebound. As we round up the clinical pipeline, I will transition to highlighting further the versatility of our platform.

Speaker 4

We validated that our Emtek technology can recruit and activate T cells against cancer. We are using the same T cell activation approach to target HIV and chronic HBV. Today, I will share the 3rd platform called Imtai, which has a different goal of turning off inflammation and is intended to treat autoimmune and inflammatory diseases. The current standards of care for ANI are systemic immune suppression, which can lead to systemic toxicity. Our vision for the future is down modulation of the immune system focused only in the organ or tissue, which is under immune attack.

Speaker 3

As part

Speaker 4

of our cancer peptide discovery work, we have been mapping the normal human peptidone. Therefore, when we want to develop a program to down modulate the immune attack in a specific organ, we have a large pre existing library of peptides that we know are tissue specific. On Slide 20, you can see our I'm Ti molecule. The blue targeting end tethers the I'm Ti to the target tissue. The purple effector end is a PD-one agonist which presses on the PD-one break to turn off the T cell.

Speaker 4

There is also an Fc fusion which prolongs the half life and enables less frequent dosing. Our first application is for patients with Type 1 diabetes, which remains a large unmet need. Type 1 diabetes results when auto reactive T cells kill pancreatic beta cells, which normally secrete insulin. To protect the pancreatic beta cells, we designed an MTI that binds to a peptide from the preproinsulin protein, which is only expressed in beta cells. The PD-one agonist effector end will turn off these auto reactive T cells.

Speaker 4

As seen in the data on the right, we see protection against autoreactive T cell killing only when using an Emtek that tethers to the beta cells. Our second candidate is for skin inflammatory diseases, including atopic dermatitis and psoriasis among others. We designed an Imtai that binds specifically to a target that is only expressed on antigen presenting cells in the skin. In a T cell stimulation assay, we observed inhibition of T cells only for an IMTI that tethers to the antigen presenting cell. This candidate has another exciting feature.

Speaker 4

It is universal and not HLA restricted. This is an example of how our technology can be broadened to all populations. This is certainly an exciting and productive period at ImmunoCor as we continue to pioneer TCR bispecifics for cancer, for infectious diseases and now for autoimmune diseases. I will hand over to Brian.

Speaker 5

Thank you, David. Good morning, everyone. Earlier today, we released our financial results for the Q4 year ended 2023. Please refer to the press release and our latest SEC filing on Form 10 ks for our full financial results. This is the first time that we report financials as U.

Speaker 5

S. Domestic filer and the comparisons I will discuss are now all in U. S. GAAP. The accounting difference between U.

Speaker 5

S. GAAP and IFRS is not significant, less than $1,000,000 net in each of the last 3 years. I will now share some of the key highlights. In our 2nd year of launch, 2023 has been an impressive year of KimTrax sales, with net revenues growing to $67,600,000 in Q4 from $62,600,000 in Q3, primarily driven by the 13% growth in the United States. Total sales for the year at 238,000,000 dollars or an increase of 70% over 2022.

Speaker 5

As Ralph mentioned, we continue to make best estimate revenue recognition assumptions and associated accruals for France until we achieve final price agreement. In line with the expansion of our portfolio, we have seen R and D and SG and A expenses increased marginally throughout 2023 with a net loss for the year of $55,000,000 or 1 point $3 per share. We expect expenses to marginally increase in 2024 as clinical development for late stage PRAME and ChemTraq programs accelerate. On Slide 25, you see our net cash position increased to $443,000,000 in 2023. Additionally, in February, we completed a 6 year $402,000,000 convertible bond offering with a 2.5% interest rate and net proceeds of $389,000,000 We intend to use $50,000,000 of these proceeds to repay our Pharmakon loan in November, which has a rate of 9.75%.

Speaker 5

Taken together, after this financing, we estimate a pro form a cash position of $782,000,000 Our KimTrak sales and current cash put us in an excellent position to transform outcomes for patients by accelerating this portfolio with multiple clinical opportunities across 3 therapeutic areas. I will now pass back to Beija.

Speaker 3

Thank you, Brian, David and Raul. As you have seen, we have multiple data readouts and study starts planned for the remainder of 2024. It will be a very busy year. Reflecting now on the pipeline, ImmunoCORE has an industry leading bispecific TCR pipeline that now spans 3 therapeutic areas and reflects the large potential of our Immtech platform. In the last 5 years, ImmunoCore has evolved from a research organization to a revenue generating sustainable company.

Speaker 3

We look forward with excitement to the next 5 years when we will maximize the value of KimTrak, expect to launch our BRAIN targeted therapy and advance our other programs in oncology, infectious disease and autoimmune disease. Now the full team will be happy to answer questions. Thank you.

Operator

Thank you. We will now be conducting a question and answer Our first question comes from the line of Michael Yee with Jefferies. Please proceed with your question.

Speaker 6

Hey guys, thanks. Good morning and great update. I had a question on the Kintrak advanced melanoma study, which has a readout at the end of the year. And I wanted to understand as part of this Phase twothree design, how you think about the primary endpoint and what you would expect the scenarios to be appreciating that I guess you could sort of go to the Phase 3 where there could be trends and you would still go to the Phase 3. Tell me about the types of different outcomes there at the end of the year given the Phase twothree design?

Speaker 6

Thank you.

Speaker 3

Thank you, Michael, for the question. David, do you want to take this one?

Speaker 4

Michael, thank you very much. The Phase 2 part of the study has dual primary endpoints of ctDNA and overall survival. At the end of the year, the ctDNA will be mature and the survival will be directional. And we believe it will be able to inform us on a couple of key questions, Michael. One is, can we drop 1 of the arms?

Speaker 4

Do we really need to include a PD-one or not? The second question we're going to ask is, can we resize the study? Is our assumptions correct? So I think at the end of the year, we'll have a top line of ctDNA overall survival trend and what the next steps are in the Phase 3.

Operator

Thank you. Our next question comes from the line of Jessica Fye with JPMorgan. Please proceed with your question.

Speaker 7

Hey, guys. Good morning. Thanks for taking our question.

Speaker 8

I was hoping you could walk through in

Speaker 7

a little more detail the various frame updates we can expect throughout the year, with details like the number of additional patients we should expect for cutaneous melanoma, how many patients we'll see for ovarian and maybe a range of patients for how many we'll see in lung? And when should we expect any update from the endometrial cohort? Thank you.

Speaker 3

Great. Thank you, Jeff. David, you want to take this one?

Speaker 4

Yes. Jeff, so we haven't commented on numbers, but I'll walk through the different readouts. For cutaneous melanoma, which matured the fastest, we'll be presenting the data that supported our decision to move to Phase 3, the data that we shared with the FDA and with KOLs and we can talk more about that if you'd like. For ovarian, we're still enrolling patients there. That was maturing at that enrollment was a little bit behind melanoma.

Speaker 4

We're still enrolling ovarian, but that data will be available in the Q2. With lung, it has been a little bit different. We're enrolling all comers with ovarian and with melanoma. With lung, we have taken a methodical approach to focus initially on subsets where we think we'll see signals before expanding more broadly. For both melanoma and ovarian and lung, in addition to monotherapy, we have combinations.

Speaker 4

For melanoma, it's PD-one combinations. For ovarian underlying, it's going to be the chemotherapy combinations.

Operator

Thank you. Our next question comes from the line of Tyler Van Buren with TD Cowen. Please proceed with your question.

Speaker 5

Hey guys, thanks for taking the question and congrats on another great chemtraq quarter. Just a follow-up on the 2nd quarter PRAME melanoma update. If I'm not mistaken, there was only one cutaneous melanoma patient ongoing as of the update during the 2nd quarter 2023 earnings. So should we expect more cutaneous monotherapy patients with the 2nd quarter update or not? And regarding the PD-one combo data, how heavily pretreated are these patients so we can understand what the bar should be that we should compare to?

Speaker 3

Thank you, Taylor. Another one for David.

Speaker 4

Yes. So for the first question, at the update last year, we just shared the update of the original ESMO patients. So we certainly will have more cutaneous melanoma patients and it will be sufficient to inform and provide reasons to leave for the Phase 3 trial. With regard to the second question, which I missed which tumor you were focused.

Speaker 5

Yes, for melanoma, with the PD-one combination data, how heavily pretreated will they be

Speaker 4

so we can understand where the bars should be? Yes.

Speaker 2

Tyler, I can address that. So it's a mixture. So there were some patients because pembro is indicated, they could be pembro naive, but many of them were previously exposed. So it's a mixed population because the primary endpoint is just safety and feasibility.

Speaker 3

That was Mohammed, our CMO.

Operator

Thank you. Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald.

Speaker 9

Congrats on the quarter. Maybe one on chemtrak in the Phase twothree relapsed refractory melanoma study and the Phase 2 readout toward year end. I think you've commented that if the data are favorable from the Phase 2 portion, they could support a compendia listing. How should we think about a compendia listing with an endpoint that's survival driven as opposed to response rate driven? Thanks.

Speaker 3

David, do

Speaker 4

you want to speak? Eric, very good question. So this is something that we'll have to decide on a data dependent fashion. The survival data will mature in 2025 And we will typically what happens, Eric, is that you submit that you write a paper or a presentation, you submit that to NCCN. So we will try and submit it, and it's up to NCCN to decide whether or not to accept it.

Speaker 4

The benefit, of course, is we already have a therapy which has shown a survival benefit albeit in a different type of melanoma.

Operator

Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Please proceed with your question.

Speaker 10

Hi, thanks for taking my question. This is Paul on for Michael. Mine are also on Frame, so maybe for David. What is your current thinking on the PRAME registrational opportunity in late mycutaneous melanoma? Is this still a focus area given your initiation of the frontline Phase 3?

Speaker 10

And if so, how do you think about response benchmarks? Does the recent accelerated approval for MTAG B impact your view on the setting? And then just a quick follow-up on on prem in lung. Can you expand on which particular subsets are in focus and overall strategy here? Thank you.

Speaker 3

So maybe David thank you, Michael, first for the questions. Maybe David to start and then Mohammed.

Speaker 4

Michael, sorry, Paul, yes. So in terms of the frame, we as a small company have to focus. And so what we have decided is to focus where we believe is both the best opportunity from a technical point of view, but also which is the largest opportunity. And so for PRAME, we're focused on first line. In the late line setting, where the pills were recently approved, that's where we have KIMTRAC in an opportunity and that trial is improving well and that trial has a survival endpoint, which will lead to a full approval, whereas the recent TILs was an accelerated approval.

Speaker 4

With regards to the lung question Yes.

Speaker 3

So do you want to take that?

Speaker 2

Happy to do that. So with lung, we know it's a very heterogeneous disease and there's distinct molecular subset. So based on well known and well described subset, the cohorts that David alluded to that we're exploring are sort of run along those lines.

Operator

Thank you. Our next questions come from the line of Greg Savage with Mizuho. Please proceed with your question.

Speaker 11

Hi. This is Ivanka for Greg. Congrats on the quarter. I just had a question on KimTrak. It appeared that the ex U.

Speaker 11

S. Sales were a little bit flat, I would say. Is there a reason for this? And how do you intend to keep growing this? And how do you also intend or how much more growth do you see in the U.

Speaker 11

S? Thank you.

Speaker 3

Thank you, Avendika. Lal, do you want to take this one?

Speaker 2

Avendika, thank you for your question. So, look, we've had a very successful set of years, a couple of years in Europe, where we've launched in Germany, France significantly, but as well as Italy and 6 other countries. So we're really at this stage where we've established CimTrak as standard of care and we are well penetrated. So we do see a relatively flat future with some of the launches incrementally adding to the growth there. Now the primary driver of growth will be the United States and that will be driven really mainly by us continuing to penetrate into the community and identifying patients earlier.

Speaker 3

And as you know, in Europe, it's about the country by country for pricing. And so that's we're continuing that.

Operator

Thank you. Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question.

Speaker 12

Great. Thank you. Thanks for taking my questions and congratulations on the quarter. Just as we think about revenues this quarter, kind of what drove the growth in the U. S.

Speaker 12

Business? Any one timers we should think about? And any guidance around how we should be thinking about 1Q numbers?

Speaker 3

Great, Peter. Great question. Ross?

Speaker 2

So Peter, we had a great 13% quarter over quarter growth in the U. S. The main driver for that, if you recall at the beginning of the year, we said we're going to be focusing on the community and that community penetration. And that's what we did. Now the majority of our scripts are coming from the community, and that's what's driving really the main part of our growth.

Speaker 2

We're also seeing duration of therapy being sustained with physicians really beyond progression. So what we expect in 2024 is the growth to incrementally continue into the U. S. And beyond 2024 in the midterm, we're expecting the as David has mentioned, a 10 AM study data as well as in the long term, the ATOM trial, which we're very excited about.

Operator

Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question.

Speaker 5

Hi, this is Charlie on for Jack. I was just wondering if for the ovarian in the PRAME franchise, would you

Speaker 2

be able to give us

Speaker 5

a little more color in terms of the size of the data set you're expecting as well as duration of follow-up and what you would consider the bar for success there?

Speaker 3

Great. Jack, thank you. Dave, if you want to take this question?

Speaker 4

Yes, Charlie. The with regard to size, we haven't been commenting on number of patients, but what we have said is that we will show data that is sufficient in order to inform the level of activity and the duration of follow-up, we believe will also be sufficient. In terms of, the bar for success, we're looking at answering 2 questions, which is that traditionally what we do in drug development, is the drug active and does that clinical activity support registrational trial. So we know the trial. So we know the drug is active.

Speaker 4

And then here in terms of clinical activity, we'll be looking at partial responses, durable tumor reduction, PFS, disease control and of course, CTD and A reduction, which is emerging as a consistent theme for our platform.

Operator

Thank you. Our next question comes from the line of Jeet Mukherjee with BTIG. Please proceed with your question.

Speaker 13

Hey, thanks for taking our question. This is Jeet on for Justin. I was hoping you could just help us think about the efficacy bar for relapse free survival for the adjuvant setting and just any thoughts around the neoadjuvant setting as well for uveal melanoma? Thanks.

Speaker 3

Great, Jeff, David, you want to take this one and maybe you could comment as well, Ross?

Speaker 4

Yes. I'll focus on the neoadjuvant first. Interestingly, in the original trial, when we looked back, we did have a couple of patients with residual melanoma in the eye. And interestingly, when we looked at those lesions, there was actually reduction in those tumor lesions. So I think neoadjuvant is an exploratory program and we have a couple of ESRs with regard to that.

Speaker 4

In terms of your first question, which was the, what is the bar for success in terms of relapse free survival? What would the control arm be? This is a high risk population.

Speaker 3

Yes. And I think Mohamad can comment on that. Yes. Sure.

Speaker 2

I'm happy to comment. So really, the way to think about this is that there is no standard, in the adjuvant setting. And so the bar there's no established bar. What we know is that the meeting time to relapse in this high risk population, which is the target population is about 3 years. And so the bar is that we have to improve above that.

Speaker 2

So this is the way to conduct a trial in the adjuvant setting, which is a randomized trial that's global that focuses on the high risk population.

Speaker 3

Great.

Operator

Thank you. Our next question comes from the line of Patrick Trucchio with H. C. Wainwright. Please proceed with your question.

Speaker 14

Thanks. Good morning and congrats on all the progress. I have a follow-up on the PRAME Phase 3 program. I'm wondering if you can discuss in more detail the strategy around pursuing first line treatment as well as the design that includes that combination with nivo. How should we think about contribution of PRAME's this regimen and understanding the study is expected to randomize the 1st patient this quarter?

Speaker 14

When do you anticipate initial data like ctDNA data to emerge? And what read through should we anticipate from that data to potential for the program success on the primary endpoint of PFS?

Speaker 3

Patrick, thank you for the question. I think David and Mohammed can take it.

Speaker 4

Yes. So Patrick, I'll try to answer of your questions. I hope I get them all. But in terms of the Phase 3 claim first line trial, I think that's what your question was. Regarding.

Speaker 4

There were, of course, multiple data points that led to that. The monotherapy activity of F106C, which we'll share, the ability to combine with anti PD-1s and then knowledge for our platform and it's true with immunotherapies in general that you always see higher activity as you move from late to the first line effect with ctDNA clearance and contract we see a tripling of clearance as we go from second line to first line. In terms of the design and the contribution of components, the design is PRAME plus nivolumab versus nivolumab. So that already has built in the contribution of components because we have frame on top of nivolumab. Now there will be a minority of patients in the control arm who do get Opdualag.

Speaker 4

But and so we'll be able to draw a point estimate, but most of the patients in comparison to Opdulag, but most of the patients will have received nivo monotherapy. So we'll have contribution of components there. And the primary endpoint is progression free survival, which is globally accepted for approval, for regulatory approval. The secondary endpoint is overall survival. We do have an exploratory endpoint of cpdna, but that won't be available until the trial is over.

Operator

Thank you. Our next question comes from the line of Bill Blum with Needham. Please proceed with your question. Good morning and thanks for squeezing me in. Maybe a quick one on your new PWEL asset and CRCC.

Operator

So generally CRCC is an immune desert. Could that be a potential issue for agents of this type? I mean, we've seen a lot of activity for Teben and the PRAME asset and more T cell infiltrated tumors. Thank you.

Speaker 3

Yes. Thank you, Gaye, for this question. I'll pass it on to Mohamad. But I just want to remind you that the Yuveen melanoma is a complete cold tumor as cold as it gets. So that's I think where our platform.

Speaker 3

You want to talk a little bit, Mohamad, about that? Yes.

Speaker 2

This is part of the reason why we're so excited about the pivotal program and our mechanism, which is very distinct from checkpoints where we don't need pre existing immunity or infiltration by the immune system into the tumor. We what we've shown with Tebby, as Bijja was alluding to, is that we just need functional T cells in the periphery and our mechanism drives T cells into a non inflamed or immune desert. So this is one of the reasons why we're excited about this program and its potential application in CRC.

Speaker 3

And then we'll let the data tell us.

Operator

Thank you. Our next question comes from the line of Naureen Quibrio with Capital One Securities. Please proceed with your question.

Speaker 15

Hi, good morning. Congrats on the quarter and thanks for taking my question. So, I guess just to follow-up on the chem track Phase twothree TED AM study. Obviously, you're going to be looking at the ctDNA and the trends with the OS. I'm just curious what kind of reduction in ctDNA do you expect in this setting sort of to help you inform the decision to drop one arm?

Speaker 15

How big of a delta are you looking at? And again, we're comparing between the two arms? Or is it just baseline from the specific arm?

Speaker 3

Great. Maureen, thank you very much. David, you want to take some?

Speaker 4

Yes. So we'll be looking so we have 3 arms, just as a reminder. We have the bendafus monotherapy, the bendafus plus cambrolizumab and then of course the control arm. And the primary the dual endpoints are ctDNA and survival. In terms of ctDNA, we believe it directionally gives us information, but since it's still exploratory in cutaneous melanoma, we will rely on survival as well.

Speaker 4

And although the survival will not be fully mature, we have done some simulations showing that we will have sufficient power to see trends in order to drop one of the arms. The size is about 40 patients per arm. And so we think we have enough power in order to make the decision, taking integrating ctDNA and survival.

Operator

Thank you. Our next question comes from the line of Jeffrey Hung with Morgan Stanley. Please proceed with your question.

Speaker 16

Hi, this is Michael Reade on for Jeff Hung. Thank you for taking our question. Could you talk a little bit more about ctDNA's predictive power on OS and advanced cutaneous versus uveal melanoma? How far in the treatment course do you need to go to have confidence in its predictive power? And does that power get stronger as you move into earlier lines?

Speaker 16

Thank you.

Speaker 4

Thank you, Michael. David, you want to take it? Yes. Michael, so the Carl, the association with survival we have validated in uveal melanoma in 2 independent trials. So when it comes to uveal melanoma ctDNA, we have really strong confidence.

Speaker 4

With cutaneous melanoma, it's we have emerging confidence, but we of course don't have randomized trials and we don't have long term survival. So we will be looking both at ctDNA directionally as an early potential surrogate and we'll be looking at survival in parallel. We hope that this trial will begin to set up the associations that we have seen in uveal, in cutaneous melanoma, but we acknowledge that we'll need to see both ctDNA and survivolin integrate both of those at this early time.

Operator

Thank you. Our next question comes from the line of Ahu Demir with Ladenburg. Please proceed with your question.

Speaker 8

Good morning. Thank you so much for taking my questions and congrats on the quarter. Two questions from us. First one is on the pre melanoma readout in the Q2. In terms of the patient follow-up, could you give us a tenth of the majority of patients, how long they were followed up for?

Speaker 8

And the second question I have is, expectation for the HIV MAT study, what does factors look like?

Speaker 3

Thank you, Ahu. David and maybe Mohammad as well.

Speaker 4

Yes. In terms of the PRAME melanoma, I do think we have sufficient follow-up in order to show durability. I don't have the exact follow-up with me right now, but I would say, Avi, that it's going to be sufficient in order to interpret the data. And that's because and the reason I say is because we enrolled a lot of those patients throughout 2023. In terms of HIV, it's a good question because no one has ever been able to show a reduction in the reservoir or a functional tear.

Speaker 4

So for the reduction of the reservoir, we'll be looking in the blood to see whether we can reduce CD4 T cells with HIV. And in terms of what success looks like that, I think we're going to have to generate the data, share it with the KOLs and then we'll share that data and we'll be able to interpret what success looks like. In terms of the delay of the viral rebound, that also is a very novel, no one has been able to show that. So I think, we're going to have to look at the data, discuss with KOLs and then we'll share the data. I think any sign of the delay in rebound that we can attribute biologically to the drug would be a success as an initial step in HIV treatment.

Operator

Thank you. Our next question comes from the line of Rajan Sharma with Goldman Sachs. Please proceed with your question.

Speaker 17

Hi. Just a quick one on KimTrak and just kind of thinking about how confident you are in maintaining pricing in a scenario where you do get these additional settings that you've talked to, which obviously potentially significantly increased the number of patients on therapy. I think it's kind you flagged 6,000 potential patients versus 1,000 currently. So I'd be keen to understand how you see that playing out.

Speaker 3

Yes, Rishan, thank you. No, I think it will be a good problem to have, but go ahead, Gerald.

Speaker 5

I agree. Thank you for

Speaker 2

the question. So look, the way we look at pricing is really the framework that we use is the value that it brings to patients, value that it brings to society. So as Bahija said, it's a little bit early for us to comment on that. So once we see the data, we hope that this is bringing significant value. Therefore, the price erosion would be minimal.

Operator

Thank you. There are no further questions at this time. I would now like to hand the call back over to Bahija Jala for any closing remarks.

Speaker 3

Thank you very much. So in closing, I would like to express really my gratitude to our patients, to our shareholders and to the team. This past year has been a testament to our drive to bring contract to patients, our innovation into bringing more novel targets and entering a new therapeutic area and as always our commitment to patients by working with a sense of urgency. And as we move forward into the next fiscal year, we remain steadfast in our mission to drive growth, create value and deliver results. I would like to end this call by thanking all of you for your support.

Speaker 3

Thank you.

Operator

Thank you. That does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

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Earnings Conference Call
Immunocore Q4 2023
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