Immunocore Q2 2026 Earnings Call Transcript

Key Takeaways

  • Positive Sentiment: KIMMTRAK first-half net revenue rose 16% year over year to $223 million, including $116 million in Q2, supported by continued U.S. community demand and penetration above 70% in major markets.
  • Positive Sentiment: Five-year data showed KIMMTRAK doubled the likelihood of survival at five years versus investigator’s choice in HLA-A2-positive metastatic uveal melanoma, with overall survival of 16% versus 8%.
  • Positive Sentiment: Enrollment in the pivotal TEBE-AM trial for previously treated advanced cutaneous melanoma is nearly complete, with headline overall-survival data potentially available by year-end 2026; ATOM and PRISM-MEL-301 also continue to advance.
  • Neutral Sentiment: Immunocore expects first-patient dosing of its type 1 diabetes candidate in the coming weeks, plans to submit a CTA for a second autoimmune candidate by year-end, and expects updated HIV data in the first half of 2027.
  • Negative Sentiment: Q2 U.S. sales benefited from approximately $6 million of distributor inventory stocking, creating a headwind for Q3, while the company expects roughly $120 million in sales-related rebate payments during the second half of 2026.
AI Generated. May Contain Errors.
Earnings Conference Call
Immunocore Q2 2026
00:00 / 00:00

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Operator

Greetings, and welcome to the Immunocore conference call and 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 the question queue at any time by pressing star one 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 zero. It is now my pleasure to turn the call over to Ryan Baker, Vice President, Investor Relations. Ryan, please go ahead.

Ryan Baker
Ryan Baker
VP of Investor Relations at Immunocore

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 KIMMTRAK results and recently published five-year overall survival data. Dr. Mohammed Dar, our Chief Medical Officer, will provide a pipeline update. Travis Coy, our CFO and Head of Corporate Development, will provide some key highlights from our financial results reported earlier this morning.

Ryan Baker
Ryan Baker
VP of Investor Relations at Immunocore

I will now turn the call over to Dr. Bahija Jallal.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

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 mission, we have continued to execute as planned across the business. We remain focused on our three strategic priorities: maximizing the value of KIMMTRAK, advancing our melanoma portfolio, and expanding into other tumor types, and realizing opportunities in infection and autoimmune diseases. Starting with KIMMTRAK, 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 ACR in April, we presented the five-year overall survival data that showed that KIMMTRAK doubles the likelihood of being alive at five years for patients with HLA-A2-positive metastatic uveal melanoma.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

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 III trials, TEBE-AM, ATOM, and PRISM-MEL-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 preproinsulin data in 2027. In autoimmune diseases, the first patient is to be dosed with our first autoimmune candidate in Type 1 diabetes in the coming weeks. We also remain on track to submit the CTA for our second autoimmune candidate by the end of 2026.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

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 I/II 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. I now ask Ralph to share details about our commercial performance. Ralph?

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

Thank you, Bahija. Today, I will cover KIMMTRAK'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 KIMMTRAK across our global markets. In the Q2, we generated $116 million in net sales, with the U.S. 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 launch countries. We continue to see over 70% penetration across our major markets and a stable duration of therapy of 14 months.

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

In our fifth year on the market, we expect moderating growth driven by continued commercial excellence, geographic expansion, and deeper penetration in the U.S. community setting. The body of evidence supporting the long-term survival benefit for patients treated with KIMMTRAK 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 eight.

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

KIMMTRAK's landmark five-year data sets the bar for overall survival in HLA-A*02:01-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 KIMMTRAK doubles the likelihood of survival at five years, with a 16% OS rate compared with 8% for investigator's choice. Importantly, the survival curve separated early and remained separated over time. In the active arm, 44% of patients alive at five years received KIMMTRAK as their only treatment. In the control arm, 87% of patients alive at five years crossed over to KIMMTRAK. Remarkably, only a single patient that did not cross over to KIMMTRAK was alive at five years.

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

The five-year OS benefit of KIMMTRAK 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 KIMMTRAK 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 lifecycle 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 sixfold through our two phase III lifecycle management trials. TEBE-AM could transform the lives of up to 4,000 patients with advanced cutaneous melanoma. The data is expected as early as the end of 2026.

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

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 KIMMTRAK and the patients we serve. I'll now hand over to Mohammed to discuss these trials in more detail. Mohammed?

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

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 TEBE-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%. TEBE-AM is the first phase III trial aiming to demonstrate an overall survival benefit, the gold standard in this setting. If TEBE-AM is positive, KIMMTRAK would be the first new therapy with an overall survival benefit in second-line plus CM. 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.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Beyond second-line, retreatment 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, TEBE-AM is a randomized phase III trial for melanoma patients who have progressed on checkpoints and, if applicable, targeted therapy. Patients are randomized to KIMMTRAK monotherapy, KIMMTRAK 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 I-B data showing a 75% one-year survival rate compared to the historical benchmark of 55%. Beyond efficacy, KIMMTRAK is an off-the-shelf therapy with a predictable and manageable safety profile that is already familiar to the melanoma community.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Enrollment is nearing the target of 540 patients, with the number of patients left to enroll now in the teens, with top-line data still expected as early as the end of this year. Turning to our second KIMMTRAK LCM registrational trial. Today, ATOM 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 KIMMTRAK or observation, with relapse-free survival as the primary endpoint. The study, sponsored by EORTC, has been enrolling patients across multiple European countries and is now enrolling in the U.S. Our goal is to bring the benefit of KIMMTRAK 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 brenetafusp, our TCR-targeting PRAME.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

The PRISM-MEL-301 trial is a randomized phase III trial in first-line cutaneous melanoma comparing brenetafusp plus nivolumab versus either nivolumab monotherapy or nivolumab plus relatlimab 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. Next, I will briefly cover the phase I/II trial with brenetafusp in heavily pre-treated patients with advanced melanoma presented recently at ASCO. These data reinforce our belief in the potential of brenetafusp plus nivo in first-line advanced melanoma. The data demonstrated a 17% overall response rate and a 67% disease control rate with brenetafusp monotherapy at the 160 microgram dose in heavily pre-treated patients with advanced melanoma.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

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 III trial in first-line advanced melanoma. The median overall survival for brenetafusp monotherapy in this late line melanoma population reached 14.3 months. This compares favorably to other phase I/II trials of combination therapies in heavily pre-treated 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 PRAME 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.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

This includes evaluating brenetafusp 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-HLE candidate, which is currently in a phase I 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.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

The modular nature of our ImmTACs 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 1,200 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 I 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.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

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-A*02:01 positive patients newly diagnosed every year. Our candidate, IMC-S118AI, is designed to bind to preproinsulin, 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 I 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 III trials in melanoma and a maturing early-stage portfolio.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

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.

Travis Coy
Travis Coy
EVP, CFO, and Head of Corporate Development at Immunocore

Thank you, Mohammed. Good morning. Good afternoon, everyone. Earlier today, we released our financial results for the Q2 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 KIMMTRAK, with Q2 net sales reaching $116 million. This represents an 18% increase over Q2 of 2025. Looking at the geographic breakdown for the quarter, the U.S. contributed $75 million, up 17% year-over-year, while Europe reached $34 million and our international regions grew to $7 million.

Travis Coy
Travis Coy
EVP, CFO, and Head of Corporate Development at Immunocore

As Ralph mentioned, it is important to note that Q2 sales in the U.S. 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 III 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.

Travis Coy
Travis Coy
EVP, CFO, and Head of Corporate Development at Immunocore

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 KIMMTRAK 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.

Travis Coy
Travis Coy
EVP, CFO, and Head of Corporate Development at Immunocore

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. I'll now turn the call back to Bahija.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Thank you, Travis, and thank you, team. The five-year overall survival data with KIMMTRAK confirms what it can deliver for HLA-A2 positive patients with MUM, while also confirming the potential of our ImmTAC platform. We look forward to sharing the TEBE-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 KIMMTRAK and the many more we intend to reach. Thank you to all our patients, their families, and our employees. Thank you for your support. Now we'll be very happy to take your questions.

Operator

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed into the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove 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 Cowen. Your line is now live.

Tyler Van Buren
Tyler Van Buren
Analyst at TD Cowen

Hi there. Good morning. Congratulations on the progress. Thanks for the question. For the TEBE-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? Can you help us understand how that is powered? If there is an interim and a final, how that's powered relative to the final.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Thank you. Mohammed, do you want to take that?

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Good morning, Tyler Van Buren. Thanks for the question. Just as a reminder, we don't usually get into the specifics of the stats plan, it's not unusual in a trial like this to have interim analysis designed into it. Just because there is an interim analysis written into the protocol doesn't mean that you have to actually execute on it. You're correct, the way the trial was designed, we don't do any data analysis until enrollment is complete. 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. We remain on track for that.

Operator

Thank you. Our next question is coming from Michael Yee from UBS. Your line is now live.

Analyst at UBS

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

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Since you have two parts, I think you can take it, Mohammed.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Sure. Happy to take those two questions. With regards to 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. That's the reason why we're still reiterating that

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

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 the experience so far in the composite trial, not by any specific arm, the use of clinical trials is very low, typically in the single-digit percentage.

Operator

Thank you. Our next question today is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.

Analyst at Cantor Fitzgerald

Hi, this is Imogen on for Eric. Good morning. For the shape of the enrollment curve for TEBE-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? As we think about the half-life extended PRAME data coming, could you help us think about expectations there and which data sets from brenetafusp would be reasonable to compare that to?

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Happy to take that. With regards to the TEBE-AM enrollment curve, I'm just giving you sort of a general experience. Once you reach all the sites are activated, you basically have steady state enrollment, and that's been our experience with the ongoing TEBE-AM trial. As I mentioned a little bit earlier, these last patients, 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. That's why we're reiterating that the headline data could be as early as the end of this year. With regards to the PRAME-HLE study, as a reminder, this is a phase I trial that's been ongoing, escalation continues. Depending on where we get to, we always have said that we share data once we have a complete story.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Depending on how that data evolves, we look forward to sharing that. With regards to comparisons with brenetafusp, many of the sites that are on the half-life extended were on the brenetafusp trial, and many of the patient types that were enrolled in brenetafusp are being enrolled in the PRAME-HLE, mainly melanoma and ovarian. Those are probably the tumor types that you'd look for to trying to compare across the two trials.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Yeah, I will just add that the molecule is almost exactly the same except for the Fc portion, basically for extended half-life, and it's the same peptide. That's why.

Operator

Thank you. Our next question today is coming from Jessica Fye from J.P. Morgan. Your line is now live.

Analyst at J.P. Morgan

Hi, this is Tanay on for Jess. I had a couple of questions on KIMMTRAK. In Q2, we saw KIMMTRAK U.S. revenues grew 17% year-on-year to $75 million. Does that 17% growth rate fall under your definition of moderate growth that you have repeatedly referred to? Where does the U.S. and Europe penetration stand today for KIMMTRAK? If you could provide additional color on split between the academic centers and community-driven penetration in the U.S., that'd be great.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Great. You were cutting off, so I hope we understood the question. I think there are several parts of the question. One is on the 17% in the U.S., is this the moderation? Then you can take the next one.

Travis Coy
Travis Coy
EVP, CFO, and Head of Corporate Development at Immunocore

Yeah. 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. 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 saying moderating growth.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

The penetration in the U.S. versus Europe.

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

Just to comment on that 17%, Travis. Part of what contributed to that 17% is unusual stocking event that we had in the U.S. of about $6 million. 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. In countries in Europe, we're about 75%-80%. It's very well penetrated across all major markets.

Operator

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

Jack Allen
Jack Allen
Analyst at Baird

Awesome. Thanks for taking the questions and congrats on the progress over the course of the quarter. I wanted to ask on TEBE-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 2026. I did want to ask, how you're coming up with the late 2026 kind of comment here. Are you looking at any blinded event rates in the study? How are those trending? Any qualitative comments would be helpful.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Mohammed, you want to take it?

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Yeah. Happy to take that question. You're correct. That's very standard as you get close to enrollment completion and looking forward to potential analysis, that there is a separate independent stats group that's looking at the combined event rate. Based on that information, that's how we're guiding to that we could have headline data as early as the end of 2026. As we get closer to that, we can certainly provide an update because the zone of uncertainty becomes more narrow.

Operator

Thank you. Our next question is coming from Shawn Rubin from Morgan Stanley Investment Management. Your line is now live.

Shawn Rubin
Analyst at Morgan Stanley Investment Management

Good morning, everyone. Hope everyone's well. Just skipping ahead on TEBE-AM in advanced cutaneous melanoma to the commercial opportunity. What proportion of the estimated HLA-positive patient base do you think you could realistically access, say, within the first three years of launch?

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

Shawn, thank you for the question. The opportunity here is up to 4,000 patients across U.S. and E.U., and this is HLA-A*02:01-positive patients. I think from a modeling perspective, 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. We would be the first off-the-shelf OS-driven therapy. I expect 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 KIMMTRAK. We expect a good uptake based on our incremental impact to date.

Operator

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

Eva Fortea
Eva Fortea
Analyst at Wells Fargo

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

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

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 KIMMTRAK, there was nothing available for these patients. Oftentimes physicians saw no benefit of having very continuous intense monitoring. Nowadays, what we've shown with KIMMTRAK, 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. We do see a little bit of a more systemic monitoring of these patients, more so than we could see before, and this is across most countries.

Operator

Thank you. Our next question is coming from Graig Suvannavejh from Mizuho. Your line is now live.

Analyst at Mizuho

Hi there. This is Doug on for Graig. Thanks for taking my question. Quick one on the brenetafusp phase I/II 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? First part of the question, then as a follow-up on brenetafusp, specifically in melanoma, since the half-life extended version is so comparable, let's say they're both successful in melanoma, how do you expect to manage that? Would they compete with each other? Would half-life extended, if all goes according to plan, sort of replace brenetafusp? Or would they go after different populations? Or is it just way too early to tell?

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Happy to take on the two questions. With regards to the expected ovarian and lung data from the phase I/II 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. 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.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

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. 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 brenetafusp is already in the frontline PRISM-MEL 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. Of course, there are other diseases like ovarian and lung that we're going to compare the data to help guide next steps.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Do you want to comment on what we built in in the trial, in the PRISM-MEL trial for the convenience, basically?

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Yes.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

This frequent dosing.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Right. In the PRISM-mel trial, even though the phase I/II development with Brenni 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 biweekly dosing, and then after a year, it switches to monthly dosing. That's built into the pivotal trial from a patient convenience perspective.

Operator

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

Romy O'Connor
Analyst at Kempen

Hi. Thank you for taking my question and the presentation today. I have a question on the sales-related rebate accruals. Of the $120 million, I just wanted to ask if you could clarify what drives the size of payment.

Romy O'Connor
Analyst at Kempen

Going forward, how should we think about the normalization here in terms of cadence, maybe? Thank you.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Great.

Travis Coy
Travis Coy
EVP, CFO, and Head of Corporate Development at Immunocore

Yes. Thanks. I'm happy to take that question. 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. That's why we're seeing a higher number in the second half of this year. Moving forward, we'd expect that those rebate payments in 2027 to return back to more similar levels to what we paid in 2025, which was in the $65 million-$70 million range.

Romy O'Connor
Analyst at Kempen

Thank you.

Operator

Thank you. Our next question is coming from Jeff Jones from Oppenheimer. Your line is now live.

Jeff Jones
Jeff Jones
Analyst at Oppenheimer

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

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

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. Clearly, KIMMTRAK is transformational 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. For instance, 44% of patients alive at five years only saw KIMMTRAK as their treatment. 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 KIMMTRAK. This is something that the team is leveraging, especially when it comes to conversations, including sometimes the conversations on treatment beyond progression.

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

We will reinforce that message, but obviously we don't expect necessarily to drive the 14 months beyond what we've seen because it's been stable for the past few quarters.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

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

Operator

Thank you. Our next question is coming from Faisal Khurshid from Jefferies. Your line is now live.

Analyst at Jefferies

Hi. Thanks so much for your question. This is Gabrielle dialing in for Faisal Khurshid. Can you speak about the extent to which you see Ideaya's oral regimen as a competitive risk to KIMMTRAK in 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 KIMMTRAK business?

Ralph Torbay
Ralph Torbay
EVP, Commercial at Immunocore

Thank you, Gabrielle, for the question. Look, I think this is good news for HLA-A*02:01 negative patients, which currently still have a very significant unmet need because they're not eligible for KIMMTRAK. On the other side, for HLA-A*02:01 positive patients, KIMMTRAK 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. Again, we discussed patients being on treatment for a long time. From a value proposition perspective, with KIMMTRAK, you're getting OS, you're getting safety that's tolerable for years. I see KIMMTRAK being very much anchored in first line.

Operator

Thank you. Our next question is coming from Rajan Sharma from Goldman Sachs. Your line is now live.

Rajan Sharma
Rajan Sharma
Analyst at Goldman Sachs

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

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Thanks for the question. I would say that the growth of ADCs in ovarian cancer highlights the unmet need in this disease. With regards to ADCs, our view is that ADCs are essentially targeted chemotherapy. Our platform has a unique mechanism, there's no reason to expect that why you couldn't combine the two. We've certainly shown in the clinic we can combine with chemotherapy. With the Garcera internal bar, I think the general approach is that you want to generate data in the intended target population, which we're doing in the brenetafusp-101 study, i.e., the maintenance trial. Then you want to look for an effect size on a relevant clinical endpoint that would justify the next stage of investment. We are looking forward to sharing that data later this year, and that will help guide the next steps.

Operator

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

Analyst at H.C. Wainwright

Hi, good morning. This is Luis in for Patrick. Thanks for taking our questions. I was wondering for your ImmTAV platform and the HIV data, you say you have it at hand and you're analyzing it. 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? What data should we expect there? Are you in any potential partnership discussions regarding that platform in general? Thank you so much.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

It's a good assumption. I think we try always to share data in a conference, that's our goal. We always talk inside and outside on data. There was another one, I think, in the question.

Analyst at H.C. Wainwright

What to expect for the data?

Bahija Jallal
Bahija Jallal
CEO at Immunocore

Yeah. That's basically, as we presented the multiple ascending dose last time, we definitely have not reached. We saw a start of a dose response, and we didn't reach a DLT, if you will. We were going up with the dose, and now, as we said, we will have data for 601.2 milligrams of data. That's what we will be sharing in the same fashion that we did for the first MAD data.

Operator

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

Jack Allen
Jack Allen
Analyst at Baird

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 KIMMTRAK 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, 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.

Mohammed Dar
Mohammed Dar
EVP, Clinical Development and CMO at Immunocore

Yeah, happy to take that. I think, if I step back, the utilization of ctDNA was data that Immunocore pioneered with our translational medicine work, and we published that for our pivotal phase III trial, showing that it looked as a better surrogate than even resist response for predicting long-term outcome. In our conversations with physicians, I think it varies. The institutions that are more academic and have access to either an in-house one or they can utilize a commercially available ctDNA, 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 ctDNA clears, they're using that as a guide to how to manage the patient. We see it based on the expertise of individual investigators and institutions and access to ctDNA.

Bahija Jallal
Bahija Jallal
CEO at Immunocore

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

Operator

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

Bahija Jallal
Bahija Jallal
CEO at Immunocore

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

Operator

Thank you. That 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.

Executives
    • Ryan Baker
      Ryan Baker
      VP of Investor Relations
    • Ralph Torbay
      Ralph Torbay
      EVP, Commercial
    • Mohammed Dar
      Mohammed Dar
      EVP, Clinical Development and CMO
    • Travis Coy
      Travis Coy
      EVP, CFO, and Head of Corporate Development
Analysts