8/6/2026

speaker
Operator
Conference Operator

Greetings and welcome to the Immunocore Conference Calling Webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. We ask that you please limit yourselves to one question, then return to the queue. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star 0. It's now my pleasure to turn the call over to Ryan Baker, Vice President, Investor Relations. Ryan, please go ahead.

speaker
Ryan Baker
Vice President, Investor Relations

Good morning and good afternoon. Thank you for joining us on our Q2 and first half 2026 earnings call. During today's call, we will make some forward-looking statements which are qualified by our safe harbor provision under the Private Securities Litigation Reform Act of 1995. Please note that actual results can vary materially from those indicated by these forward-looking statements. including those discussed in our filings with the SEC. On today's call, I am joined by Dr. Bahija Jallal, CEO of Immunocore, who will share achievements from the first half of 2026. Ralph Torbay, Chief Commercial Officer, will review our Q2 first half chem track results and recently published five-year overall survival data. Dr. Mohammad Dar, our Chief Medical Officer, will provide a pipeline update and Travis Coy, Our CFO and head of corporate development will provide some key highlights from our financial results reported earlier this morning. I will now turn the call over to Dr. Bahija Jallal.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Good morning and good afternoon, and thank you for joining us today. Before I start, I would like to welcome Ryan Baker, who joined us last week as our new vice president of investor relations. So welcome, Ryan. Guided by our missions, We have continued to execute as planned across the business. We remain focused on our three strategic priorities, maximizing the value of chemtraq, advancing our melanoma portfolio, and expanding into other tumor types, and realizing opportunities in infection and autoimmune diseases. Starting with KimTrack, we generated $223 million in net revenue in the first half of the year, representing 16% growth compared to the first half of 2025. At ASCR in April, we presented the five-year overall survival data that showed that KimTrack doubles the likelihood of being alive at five years for patients with HLA-A2 positive metastatic uveal melanoma. For a disease once measured in months, five years is extraordinary. And some of those patients are alive today because of this medicine. This is why we come to work every day. In melanoma, we are advancing three ongoing phase three trials, TEBI-AM, ATOM, and PRISML-301. An important differentiator for a company of our size. Beyond melanoma, we expect to present updated PRAME data in additional tumor types by the end of the year and to provide initial P-WELL data in 2027. In autoimmune diseases, the first patient is to be dosed with our first autoimmune candidates in type 1 diabetes in the coming weeks. We also remain on track to submit the CTA for our second autoimmune candidates by the end of 2026. Finally, in HIV, we have completed enrollment of additional patients at higher dose cohorts up to 1.2 mgs as part of the multiple ascending dose part of the Phase 1-2 trial. We are analyzing the new data and plan to share results early next year. Overall, we are continuing to execute across our commercial portfolio and pipeline with multiple opportunities to create value for patients and shareholders. And now ask Ralph to share details about our commercial performance. Ralph?

speaker
Ralph Torbay
Chief Commercial Officer

Thank you, Bahija. Today, I will cover Chemtrax's continued commercial momentum, our landmark five-year OS data, and our ongoing growth opportunities across melanoma. We delivered $223 million in net sales during the first half of 2026, representing a 16% year-on-year growth and reflecting the sustained strength of KimTrack across our global markets. In the second quarter, we generated $116 million in net sales, with the US contributing $75 million and serving as a primary growth driver. This strong performance was supported by continued demand growth in the community as well as $6 million in inventory stocking by a U.S. distributor. This increase in inventory will create a headwind in Q3. The fundamentals of the business remain very strong across our 30-plus launched countries. We continue to see over 70% penetration across our major markets in a stable duration of therapy of 14 months. In our fifth year on the market, we expect moderating growth driven by continued commercial excellence The body of evidence supporting the long-term survival benefit for patients treated with KimTrack continues to build. We presented French real-world evidence showing a median overall survival of 28 months and more recently presented the five-year survival data from our registrational trial, which I will discuss in slide 8. Kimtrek's landmark five-year data sets the bar for overall survival in HLA-021-positive first-line metastatic uveal melanoma. It is also the longest OS follow-up ever reported in a randomized metastatic uveal melanoma trial and for any T-cell engager in a solid tumor. This data shows that treatment with Kimtrek doubles the likelihood of survival at five years with a 16% OS rate compared with 8% for investigators' choice. Importantly, the survival curve separated early and remained separated over time. In the active arm, 44% of patients alive at five years received Chemtrak as their only treatment. In the control arm, 87% of patients alive at five years crossed over to Chemtrak. Remarkably, only a single patient that did not cross over to ChemTrack was alive at 5 years. The 5-year OS benefit of ChemTrack was observed across key subgroups including those with poor prognostic features such as high tumor burden, elevated LDH, and extrahepatic disease. These results clearly demonstrate that starting with ChemTrack in first line gives patients the best chance at extending long-term survival. I'm excited about the opportunity to potentially extend this benefit to more patients through our life cycle management program, which I will discuss on the next slide. Today, we're serving approximately 1,000 patients per year in metastatic uveal melanoma. Our focus now is on scaling this momentum with the potential to expand the number of patients six-fold through our two phase three life cycle management trials. Heavy AM could transform the lives of up to 4,000 patients with advanced cutaneous melanoma. The date is expected as early as the end of 2026. Our ATOM trial in adjuvant uveal melanoma could help up to 1,200 patients live without their disease. I am confident in our ability to execute on this growth trajectory, and I'm excited about what's ahead for ChemTrack and the patients we serve. I'll now hand over to Mohamed to discuss these trials in more detail.

speaker
Dr. Mohammad Dar
Chief Medical Officer

Thank you, Ralph. I'm pleased to be able to share the progress we've made across our pipeline. I will now begin with our three registrational melanoma trials, starting with TEBI-AM on slide 12. Our lead registrational opportunity is in advanced cutaneous melanoma, where there is high unmet need. No therapy has proven to extend survival in second-line plus cutaneous melanoma following checkpoint inhibitors and targeted therapy, with one-year overall survival in this setting remaining unchanged at approximately 55%. TebEM is the first Phase III trial aiming to demonstrate an overall survival benefit, the gold standard in this setting. If TebEM is positive, Kintrac would be the first new therapy with an overall survival benefit in second-line plus As a reminder, first-line patients typically receive either anti-PD-1 with or without additional checkpoints or BRAF-targeted therapy. In second-line, patients can switch between these classes where appropriate. Beyond second-line, re-treatment with prior therapy, chemotherapy, and clinical trials remain the primary options. The only recently approved therapy under accelerated approval in this setting is TIL therapy based on response rate, not overall survival. As a reminder, TEB-EM is a randomized phase three trial for melanoma patients who have progressed on checkpoint and, if applicable, targeted therapy. Patients are randomized to chemtrak monotherapy, chemtrak plus pembrolizumab, or a control arm with a primary endpoint of overall survival. Our confidence in this program is based on multiple considerations, including the promising Phase 1b data showing a 75% one-year survival rate compared to the historical benchmark of 55%. Beyond efficacy, KimTrack is an off-the-shelf therapy with a predictable and manageable safety profile that is already familiar to the melanoma community. Enrollment is nearing the target of 540 patients, with the number of patients left to enroll now in the team with top line data still expected as early as the end of this year. Now turning to our second ChemTrack LCM registrational trial. Today, ADAM is the only uveal melanoma registrational trial actively enrolling in the adjuvant setting where there is currently no approved standard of care. High risk patients are randomized to either ChemTrack or observation with relapse-free survival as the primary endpoint. The study, sponsored by URTC, has been enrolling patients across multiple European countries and is now enrolling in the U.S. Our goal is to bring the benefit of chemtrax to uveal melanoma patients earlier, potentially delaying or even eliminating the onset of metastatic disease. Our third registrational opportunity is also in melanoma, this time with brunetifus, our TCR targeting crane. The PRISM-MEL 301 trial is a randomized phase 3 trial in first-line cutaneous melanoma, comparing bernetafos plus nivolumab versus either nivolumab monotherapy or nivolumab plus roletumab with progression-free survival as the primary endpoint. We have now successfully activated over 200 sites globally and are targeting enrollment completion by late 2027. I will briefly cover the Phase 1-2 trial with brunetifus in heavily pretreated patients with advanced melanoma presented recently at ASCO. These data reinforce our belief in the potential of brunetifus plus NEVO in first-line advanced melanoma. The data demonstrated a 17% overall response rate and a 67% disease control rate with brunetifus monotherapy at the 160-microgram dose in heavily pretreated patients with advanced melanoma. Relative to the 40-microgram dose, the higher efficacy observed with the 160-microgram dose, despite this cohort having less favorable prognostic factors, supports selection of this dose for the ongoing phase 3 trial in first-line advanced melanoma. The median overall survival for Bernadifus monotherapy in this late-line melanoma population reached 14.3 months. This compares favorably to other phase 1-2 trials of combination therapies in heavily pretreated patients with advanced melanoma, including recent studies with autologous cell therapies. I will now turn to the remainder of oncology pipeline, starting on slide 18. Beyond cutaneous melanoma, we are focused on expanding the frame franchise into other tumors. Specifically, ovarian and non-small cell lung cancer. In ovarian cancer, we're building on the monotherapy activity observed in late-line settings by moving into earlier lines of treatment. This includes evaluating Bernadifus in combination with chemotherapy in platinum-resistant ovarian cancer and in combination with Bevacizumab in platinum-sensitive maintenance settings. For lung cancer, our efforts remain focused on signal detection of monotherapy across various molecular subsets, as well as evaluating combinations with multiple standards of care. We expect to present data from these ovarian and lung cohorts later this year, which will inform next steps. In parallel, we are advancing our PRAME half-life extended candidate, which is currently in a phase one dose escalation trial. Our hypothesis for this molecule is twofold. First, to provide patient convenience through less frequent dosing, and second, to potentially increase the overall response rate. As data become available, we will determine the best next steps for the franchise. The modular nature of our Intax platform allows us to expand our reach beyond oncology and potentially unlock significant growth opportunities in infectious disease and autoimmunity. Last year, we shared preliminary data from an ongoing multiple ascending dose study in people living with HIV. The data demonstrated a delay in viral rebound after treatment interruption in a small number of patients at higher doses. Since then, we have completed enrollment of additional patients at higher doses, including 1200 micrograms. We are now in the process of analyzing these data and plan to share an update in the first half of 2027. Now turning to our third therapeutic area, autoimmunity. Our phase one trial in type 1 diabetes is now open and actively screening patients, and we expect the first patient to be dosed in the coming weeks. This will be an important milestone representing our first tissue-specific autoimmune candidate to enter clinical testing. There is high unmet medical need in type 1 diabetes with 50,000 HLA-0201 positive patients newly diagnosed every year. Our candidate, S118-AI, is designed to bind to pre-pro-insulin, which is expressed exclusively on beta cells of the pancreas. In April, our preclinical data was published and made the cover of Science Advances, validating the science behind our clinical candidate. We are now turning our focus to our Phase 1 study that is designed to provide both early evidence of target engagement, as well as Immune Modulation Leveraging a Clinically Validated Endpoint of C-Peptide Levels. To recap, we continue to advance a diversified pipeline across all three therapeutic areas anchored by our three ongoing phase three trials in melanoma and a maturing early stage portfolio. We remain focused on execution as we approach several important data milestones over the coming months. I will now hand the call to Travis to discuss our financial results.

speaker
Travis Coy
Chief Financial Officer and Head of Corporate Development

Thank you, Muhammad. Good morning. Good afternoon, everyone. Earlier today, we released our financial results for the second quarter and first half of 2026. Please refer to the press release and our latest SEC filing for our full financial results. Let me share some of our key financial highlights from the quarter and provide some commentary on expectations for the remainder of the year. We are pleased to report continued strong performance for ChemTrack. with second quarter net sales reaching $116 million. This represents an 18% increase over Q2 of 2025. Looking at the geographic breakdown for the quarter, the US contributed $75 million, up 17% year over year, while Europe reached $34 million and our international regions grew to $7 million. As Ralph mentioned, it is important to note that Q2 sales in the US were partially influenced by wholesaler stocking of approximately $6 million. If you normalize for the stocking, our underlying quarterly sequential growth was 3%. This is in line with our expectations for moderating sales growth moving forward given our high market penetration. Moving to expenses, our R&D spend for the quarter was $74 million compared to $69 million in the prior year. This increase was primarily due to advancement of our clinical programs, including our three phase three trials. As we look ahead, we continue to expect R&D expenses to modestly increase year over year, although at a slower rate than in 2025. Turning to SG&A, this quarter's expenses were $44 million, up marginally from $43 million in Q2 of last year. We will continue to be disciplined with our SG&A spend and may incur incremental increases in these investments as we prepare for the potential expansion of ChemTrack into cutaneous melanoma. This quarter, we had a net loss of just under $1 million, an improvement versus a $10 million loss in the same period of last year. Our balance sheet remains exceptionally strong. As of June 30th, we held $880 million in cash and marketable securities. This is an increase of $16 million since the beginning of the year. One last item to note is we expect to pay approximately $120 million in sales-related rebates during the second half of this year. This amount is higher than in prior years due to our revenue growth in Europe and the completion of the pricing agreement with France in early 2025, which resulted in rebates from revenue generated the prior five years being payable this year. As a reminder, these rebates impact cash only. Moving forward in 2027, we expect these rebate payments to return to similar amounts as paid in 2025. Our strong balance sheet provides the flexibility to support near-term commercial execution and pipeline advancement, while continuing to invest in longer-term growth opportunities across our business.

speaker
Ryan Baker
Vice President, Investor Relations

I'll now turn the call back to Bahija.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Thank you, Travis, and thank you, team. The five-year overall survival data with ChemTrack confirms what it can deliver for HLA-A2 positive patients with MUM, while also confirming the potential of our MTAX platform. We look forward to sharing the TEBI-AM data as early as the end of 2026, which could offer a much-needed treatment option for patients with advanced cutaneous melanoma. Our teams are working to enroll our multiple ongoing clinical trials to deliver data for our other candidates through 2026 and beyond. Behind all of this work are patients, the one alive today because of ChemTrack and the many more we intend to reach. Thank you to all our patients, their families, and our employees. Thank you for your support. And now we'll be very happy to take your questions.

speaker
Operator
Conference Operator

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to move your question from the queue. As a reminder, we ask that you please ask one question, then return to the queue. Our first question today is coming from Tyler Van Buren from TD Cal, and your line is now live.

speaker
Tyler Van Buren
Equity Research Analyst at TD Cowen

Hi there. Good morning. Congratulations on the progress. Thanks for the question. For the TEPI-AM trial, can you please review the study plan for us with respect to the potential interim or interims and a final analysis, specifically the potential top line readout that is possible by year end? I assume that must be the first interim OS analysis, considering that enrollment is not completed. Or am I wrong there? And can you help us understand how that is powered? And if there is an interim and final, how that's powered relative to the final?

speaker
Dr. Bahija Jallal
Chief Executive Officer

Thank you. Mohammed, you want to take that?

speaker
Dr. Mohammad Dar
Chief Medical Officer

Yeah. Good morning, Tyler. Thanks. Thanks for the question. So, you know, just as a reminder, we don't usually get into the specifics of the stats plan, but it's not unusual in a trial like this to have interim analysis designed into it but just because there is an interim analysis written into the protocol doesn't mean that you have to actually execute on it and you're correct the way the trial was designed we don't do any data analysis until enrollment is complete and we are still on track as we've said before that the earliest possible readout of the headline data can be as early as the end of this year so we remain on track for that

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question is coming from Michael Yee from UBS.

speaker
Operator
Conference Operator

Your line is now live.

speaker
Dina Ahn
Analyst at UBS (on behalf of Mike Yee)

Hi, thanks so much for the question. This is Dina Ahn for Mike. I know that you guys are not done yet enrolling the second line melanoma trial, and I think guidance is first half, so maybe just getting maybe a month or so behind. But just thinking about the timing is still reiterated for year end. I mean, is there any risk that this can fall into 2027? And if it does, can we presume that the chem track arms are potentially doing better versus the control arm? I guess on the control arm also, what percent of the patients do you think would be on a clinical trial versus chemo or IL retreatment? Thanks so much.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Okay, since you have two parts, I think you can take it.

speaker
Dr. Mohammad Dar
Chief Medical Officer

Sure, happy to take those two questions. So with the rest of your first question, It's important to remember that regardless, especially for the patients that are being enrolled now, they typically have very minimal impact on the primary endpoint, which is event-driven in its overall survival. So that's the reason why we're still reiterating that the earliest possible readout can be as early as the end of this year. With regards to the control arm and the possibility of clinical trials, both based on our real-world evidence and sort of the experience so far, In the composite trial, not by any specific arm, the use of real of clinical trials is very low, typically in the single digit percentage.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question today is coming from Eric Schmidt from Cancer Pitch Audioline is now live.

speaker
Imogen
Analyst at Cancer Pitch (on behalf of Eric Schmidt)

Hi, this is Imogen on for Eric. Good morning. For the shape of the enrollment curve for TEBI-AM, could you just provide a little bit more color on that and how that could lead to the event rates being hit maybe for an interim or a final analysis later this year? And then as we think about the half-life extended PREEM data coming, could you help us think about expectations there and which data sets from Brenny would be reasonable to compare that to?

speaker
Dr. Mohammad Dar
Chief Medical Officer

Happy to take that. So with regards to the TEB-EAM enrollment curve, you know, once we reach, this is, I'm just giving you sort of a general experience, right? Once you reach sort of all the sites are activated, then you basically have steady state enrollment. And that's been our experience with the ongoing TEB-EAM trial. And as I mentioned a little bit earlier, these last patients that even though There's a few weeks delay. These last patients typically don't have any impact. The impact usually comes from patients that have enrolled much earlier on the primary endpoint. So that's why we're reiterating that the headline data could be as early as the end of this year. With regards to the PREEM HLE study, this is, as a reminder, this is a phase one trial that's been ongoing. So escalation continues. And so depending on where we get to, we always have said that we share data once we have a complete story. Depending on how that data evolves, we look forward to sharing that. With regards to comparisons with BRENI, so many of the sites that are on the Half-Life Extended were on the BRENI trial and many of the patient types that were enrolled in BRENI are being enrolled in the Prane HLE, mainly melanoma and ovarian. So that's the so those are the probably the tumor types that you'd look forward to trying to compare across the two trials.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Yeah and I will just add that you know the molecule is almost exactly the same except for the FCE portion basically for extended half-life and it's the same peptide and so that's why.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question today is coming from Jessica Five from JP Morgan. Your line is now live.

speaker
Tanmay
Analyst at JPMorgan (on behalf of Jessica)

Hi, this is Tanmay on Purchase. I had a couple of questions on ChemTrack. In Tokyo we saw ChemTrack U.S. revenues grew 17% year-on-year to $75 million. So does that 17% growth rate fall under your definition of moderate growth that you have repeatedly referred to? and where does the U.S. and Europe penetration stand today for GIMCRAC and if you could provide additional color on split between the academic centers and community-driven penetration in the U.S. that would be great.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Great so you you were cutting off so I hope we understood the the question I think there are several parts of the question so one is on The 17% in the U.S. is just the moderation, and then you can take the next one.

speaker
Travis Coy
Chief Financial Officer and Head of Corporate Development

I'm happy to start, and apologies if I don't answer your question directly. You were breaking up, and I'm going to do my best to interpret what you asked. I think you asked about the 17% growth being considered moderate. I think one of the things that – look, that's year-on-year growth. So one of the things to consider is given we're on the fifth year on the market and have very high penetration across all major markets, we've seen our quarterly sequential growth moderate, and that's what we mainly refer to when we're seeing moderating growth.

speaker
Dr. Bahija Jallal
Chief Executive Officer

The penetration in the U.S. versus Europe.

speaker
Ralph Torbay
Chief Commercial Officer

Just to comment on that 17%, Travis. Part of what contributed to that 17% is an unusual stocking event that we had in the U.S. of about 6 million. So this is why you're seeing also this higher number than what we expect to be moderating. With regard to penetration, the reason why we believe this is moderating is because we're above 70% penetrated in the U.S., That includes 70% of our prescriptions coming from the community. And in countries in Europe, we're about 75, 80%. So very well penetrated across all major markets.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question is coming from Jack Allen from Bayer. Your line is now live.

speaker
Jack Allen
Analyst at Bayer

Awesome. Thanks for taking the questions, and congrats on the progress over the course of the quarter. I wanted to ask on Tevye AM. I appreciate that you're still enrolling the final patients in the study and that they might not have an impact on the analysis that could occur as early as late 26. I did want to ask how you're coming up with the late 26 kind of comment here. Are you looking at any blinded event rates in the study and how are those trending? Any qualitative comments would be helpful.

speaker
Dr. Mohammad Dar
Chief Medical Officer

Yeah, happy to take that question. So you're correct. I mean, that's very standard as you get close to enrollment completion and looking forward to potential analysis. But there is a separate independent stats group that's looking at the combined event rate. And so based on that information, that's how we're guiding to that we could have headline data as early as the end of twenty six. As we get closer to that, we can certainly provide an update because the zone of uncertainty becomes more narrow.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you.

speaker
Operator
Conference Operator

Our next question is coming from Sean Lawman from Morgan Stanley Investment Management. Your line is now live.

speaker
Sean Lawman
Portfolio Manager at Morgan Stanley Investment Management

Good morning, everyone. I hope everyone's well. Just skipping ahead on TBAM and advanced cutaneous melanoma to the commercial opportunity. So what proportion of the estimated HLA-positive patient base do you think you could realistically access, say, within the first three years of launch?

speaker
Ralph Torbay
Chief Commercial Officer

Sean, thank you for the question. The opportunity here is up to 4,000 patients across U.S. and EU, and this is HLA-O2-1-positive patients. you know I think from a modeling perspective and this is obviously very much dependent on the data itself because this is an area of high unmet need there's little to no therapies approved in this setting and we would be the first off-the-shelf OS driven therapy so I expect a good a good uptake especially since we're building from our base where currently 50% of patients with cutaneous melanoma are being treated by physicians experienced with chemtraq. So we expect a good update based on our incremental impact today.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question today is coming from Eva Fortea from Wells Fargo. Your line is now live.

speaker
Eva Fortea
Equity Research Analyst at Wells Fargo

Hi team, thanks for taking our question and congrats on the progress. A quick one from us on Kintrac. Are you seeing patients getting diagnosed a little bit earlier in disease driven by the availability of Kintrac now for five years in the market? Or are the numbers still what you were expecting five years ago? Thanks.

speaker
Ralph Torbay
Chief Commercial Officer

So, thanks for the question. The numbers that we're seeing today actually we have seen some improvement when it comes to monitoring. Keep in mind that before ChemTrack there was nothing available for these patients. So oftentimes physicians saw no benefit of having very continuous intense monitoring. Nowadays we've shown with ChemTrack and in fact you see in our data that patients with lower tumor burden as you'd expect with many therapies and especially immunotherapies do extremely well. The hazard ratio for these patients was 0.36. So we do see a little bit of a more systemic Thank you.

speaker
Ryan Baker
Vice President, Investor Relations

Our next question is coming from Greg Zivanovic from Mizuho.

speaker
Operator
Conference Operator

Your line is now live.

speaker
Doug
Analyst at Mizuho (on behalf of Greg Zivanovic)

Hi there. This is Doug on for Greg. Thanks for taking my question. A quick one on the BRINETEFUS phase 1-2 studies in ovarian cancer and non-small cell lung cancer. just sort of like what we should be expecting to come from that data how robust the data sets are these like ORR numbers that are really going to help you sort of choose what indications to pursue in advance and then first part of the question then as a follow-up on Bernadifus specifically in melanoma since the half-life extended version is so comparable like let's say they're both successful in melanoma How do you expect to manage that? Would they compete with each other? Would have like extended, if all goes according to plan, sort of replace Bernadifus? Or would they like go after different populations? Or is it just way too early to tell?

speaker
Dr. Mohammad Dar
Chief Medical Officer

Happy to take on the two questions. With regards to the expected ovarian and lung data from the Phase 1-2 trial, with ovarian, we already saw an initial signal in late-line platinum-resistant ovarian cancer about two years ago. So we're building on that. So there should be two parts to that. One is longer follow up of that original monotherapy cohort so we can look at survival, which was not mature two years ago. And since then, we've pivoted to earlier lines and are looking at combinations with standard of care, especially Bevacizumab in the platinum sensitive maintenance setting. But this will be a safety size cohort where we're looking at initial safety and feasibility, but also we'll have the ability to look at initial clinical activity. With regards to lung, we're still signal seeking. but the monotherapy cohort in terms of size would be similar to what we've shared with ovarian and melanoma but across multiple molecular subsets as you know lung is quite heterogeneous and then we have safety size cohorts with standards of care within lung. With regards to the HLE question I think it's still too early to tell but the way we're thinking about this is that obviously Brinetophis is already in the frontline Prisomel study and we have full confidence in that trial. HLE, because it at minimum offers patient convenience, could certainly be positioned for earlier lines of therapy where that becomes important, such as adjuvant setting. And then, of course, there are other diseases like ovarian and lung that we're going to compare the data to help guide next steps.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Do you want to comment on what we built in in the trial, in the Prisomel trial for the convenience? Basically, it's frequent dosing.

speaker
Dr. Mohammad Dar
Chief Medical Officer

Right. So in the PRISM-L trial, even though the phase 1-2 development with BRANI was weekly, given it's now combined with nivolumab, the way the trial is designed is after the first three months of weekly dosing, it switches to bi-weekly dosing. And then after a year, it switches to monthly dosing. So that's built into the pivotal trial from a patient convenience perspective.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question today is coming from Romeo O'Connor from Kempin. Your line is now live.

speaker
Kempin

Hi, thank you for taking my question in the presentation today. I have a question on the sales-related rebate accruals. So of the $120 million, I just wanted to ask if you could clarify what drives this size of payment. And going forward, how should we think about the normalization here in terms of Thanks.

speaker
Travis Coy
Chief Financial Officer and Head of Corporate Development

I'm happy to take that question. So two things have contributed to the rebate payments that we expect to make in the second half of this year. One is our sales in Europe have been growing. And two is the pricing agreement with France that we struck in early 2025, which allotted for cash rebate payments to be made over rebates that have been accrued the prior five years in the second half of this year. So that's where we're seeing a higher number in the second half of this year. Moving forward, we'd expect those rebate payments in 2027 to return back to more similar levels to what we paid in 2025, which was in the $65 to $70 million range.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question is coming from Jeff Jones from Oppenheimer.

speaker
Operator
Conference Operator

Your line is now live.

speaker
spk13

Thanks for taking the question guys. Quick one regarding the ACR results and the five year over survival. Do you expect that to have any impact on duration of therapy, which I believe sits around 14 months for contract right now?

speaker
Ralph Torbay
Chief Commercial Officer

Jeff, thank you for the question. I'm very excited about these five-year results. Obviously, this is the first time that we talk about five-year survival in this disease. So, clearly, ChemTrack is a transformation for a lot of these patients. The five-year results themselves will probably not have an impact, but it allowed us to see certain aspects of why we have a 14-month duration of therapy. So, for instance, 44% of patients alive at five years only saw ChemTrack as their treatment. So that speaks to the safety, the long-term safety, and the fact that a lot of the efficacy that we're seeing in these curves is driven by chemtrails. And this is something that the team is leveraging, especially when it comes to conversations, including sometimes in conversations on treatment beyond progression. So we will reinforce that message, but obviously we don't expect the cell to drive the 14 months beyond what we've seen because it's been stable for the past few quarters.

speaker
Dr. Bahija Jallal
Chief Executive Officer

The 14 months are already much higher than what we've seen in clinical trials, which tells you again how ChemTrack is really being successful in the market.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question is coming from Faisal Khurshid from Jefferies.

speaker
Operator
Conference Operator

Your line is now live.

speaker
Gabrielle
Analyst at Jefferies (on behalf of Faisal Khurshid)

Thanks so much for your question. This is Gabrielle dialing in for Faisal Khurshid. Can you speak about the extent to which you see Edea's oral regimen as a competitive risk to chemtraq and uveal melanoma? They've spoken about potentially getting HLA positive patients into their initial label, and if they do, how do you think about the impact to the chemtraq business?

speaker
Ralph Torbay
Chief Commercial Officer

Thank you, Gabriela, for the question. Look, I think this is good news for HLA-021 negative patients, which currently still have a very significant unmet need because they're not eligible for KimTrack. On the other side, for HLA-021 positive patients, KimTrack is the standard of care across all major markets. This is underpinned by five-year overall survival data that we just discussed and really a safety that's quite exceptional. And again, we discussed patients being on treatment for a long time. So from a value proposition perspective, with Chemtraq you're getting OS, you're getting safety that's tolerable for years. So I see Chemtraq being very much anchored in first line.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you. Our next question is coming from Roger Sharma from Goldman Sachs, your line is now live.

speaker
Roger Sharma
Equity Research Analyst at Goldman Sachs

Hi, thanks for taking the question. I just wanted to follow up on some of the comments on Brenny. So I was just wondering if you could discuss your internal bar in ovarian cancer in the context of all the ADCs that we're seeing in development there, as well as the ematics data that we saw at ASCO. What would you need to see to progress development in the setting? Thank you.

speaker
Dr. Mohammad Dar
Chief Medical Officer

Thanks for the question. I would say that the growth of ADCs in ovarian cancer We've certainly shown in the clinic we can combine with chemotherapy. With the Garsura internal bar, I think, you know, the general approach is that you want to generate data in the intended target population, which we're doing in the BRNI 101 study, i.e. the maintenance trial. And then you want to look for an effect size on a relevant clinical endpoint that would justify the next stage of investment. So we are looking forward to sharing that data later this year, and that will help guide the next steps.

speaker
Operator
Conference Operator

Thank you. Our next question today is coming from Patrick Trujillo from HCWainwright. Your line is now live.

speaker
Luis
Analyst at H.C. Wainwright (on behalf of Patrick Trujillo)

Hi, good morning. This is Luis in for Patrick. Thanks for taking our questions. I was wondering for your Intav platform and the HIV data, you say you have it at hand and you're analyzing it and you're planning to present the results from that analysis early in 2027. Should we assume that's going to be at the CROI conference like last year? and what data should we expect there? And are you in any potential partnership discussions regarding that platform in general? Thank you so much.

speaker
Dr. Bahija Jallal
Chief Executive Officer

It's a good assumption. I think so we try always to share data in a conference. So that's our goal. We always talk inside and outside on data. but there was another one I think in the question what to expect for the data yeah so that's basically as we presented the multiple ascending dose last time we definitely have not reached we saw a start of those those response and we didn't reach a DLT if you will so we were going up with the with the dose and now as we said we will have data for 601.2 milligrams of data. So that's what we will be sharing in the same fashion that we did for the first MAD data.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you.

speaker
Operator
Conference Operator

Our next question is from Jack Allen from Baird. Your line is now live.

speaker
Jack Allen
Analyst at Bayer

Hey, thanks for taking the follow-up. I wanted to ask about something that I heard from a KOL recently that we were discussing. The utilization of KimTrack in the first line uveal melanoma setting. They alluded to a lot of their patients receiving ctDNA monitoring for response and obviously you've seen a pretty durable duration of treatment of 14 months in the commercial setting. I'm just curious you know to what extent in your conversations with physicians are they monitoring ctDNA because I know progression can occur on the drug but ctDNA really seems to be the indicator of response and benefit.

speaker
Dr. Mohammad Dar
Chief Medical Officer

Yeah, happy to take that. I think, you know, if I step back, the utilization of CTNA was data that Immunocore pioneered with our translational medicine work, and we published that for both, for our pivotal phase three trial, showing that it looked as a better surrogate than even resist response for predicting long-term outcomes. In our conversations with physicians, I think it varies, so institutions that are More academic and have access to either an in-house one or they can utilize commercially available CT DNA. We definitely see that they will leverage this to help guide treatment decisions. Others are using it in a setting where a patient has been on therapy for a long time, multiple years, and if the CT DNA clears, they're using that as a guide to how to manage the patient. So we see it based on The expertise of individual investigators and institutions and access to ctDNA.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Which I think we have to say, you know, we have patients five years, six years, seven years, which was completely unheard of. So really happy with that.

speaker
Ryan Baker
Vice President, Investor Relations

Thank you.

speaker
Operator
Conference Operator

We reached out of our question and answer session. I'd like to turn the floor back over for any further closing comments.

speaker
Dr. Bahija Jallal
Chief Executive Officer

Right. Thank you very much. I really would like to be on behalf of the team to Thank you for your questions and thank our shareholders for their support. So thank you very much.

speaker
Operator
Conference Operator

Thank you. It does conclude today's teleconference and webcast and we disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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