Immunocore - Q4 2025
February 25, 2026
Transcript
Operator (participant)
note that this conference is being recorded. I will now turn the conference over to Morgan Morse, Investor Relations. Thank you, Morgan. You may begin.
Morgan Morse (Investor Relations Manager)
Thank you, Daryl. Good morning and good afternoon. Thank you for joining us on our Q4 and Full Year 2025 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 our 2025 overview and achievements. Ralph Torbay, Head of Commercial, will review our Q4 and full year KIMMTRAK results. Mohammed Dar, our Chief Medical Officer, will provide a pipeline update, including our ongoing registrational late-line cutaneous melanoma and other highlights across our pipeline.
Finally, 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 to Dr. Bahija Jallal.
Bahija Jallal (CEO)
Thank you, Morgan. Good morning and good afternoon, thank you all for joining us. 2025 was a year of consistent execution across every part of our business. I am pleased to share our results and where we're headed as we continue to deliver on our mission. For the year 2025, we generated $400 million in net revenue from KIMMTRAK, up over 29% from the prior year. KIMMTRAK is now approved in 39 countries and launched in 30 markets. Growth continues to be driven by deeper U.S. community penetration and continued global expansion. Real-world duration of therapy is now 14 months, exceeding our clinical trials experience. Before KIMMTRAK, patients with uveal melanoma diagnosis were given 12 months or less to live. Now, with KIMMTRAK, it's not unusual to see patients living three, four, five years or more.
This is why we're here, this is why we come to work every day. We're not stopping here. To reach even more patients, we're expanding the reach of KIMMTRAK through a robust lifecycle management program with two phase III trials. TEBE-AM in second-line cutaneous melanoma, enrollment on track for the first half of 2026 completion. ATOM in adjuvant uveal melanoma, enrolling across multiple sites in Europe and planning to open sites in the U.S. in 2026. This is, to our knowledge, the only active phase III in this setting. Beyond KIMMTRAK, we have our third phase III trial, which is PRISM-MEL-301, with brenetafusp in first-line cutaneous melanoma. The IDMC has selected the 160 microgram dose, which is the highest dose, in last December.
We are also expanding our oncology platform beyond melanoma into ovarian and lung colorectal cancer and GI cancers. Mohammed will share more details later. Beyond oncology, we presented promising data for our HIV functional cure program at CROI, and our Hepatitis B candidate showed encouraging phase I results at AASLD, confirming the potential of our platform in infectious disease. In autoimmune diseases, we submitted the CTA for our Type 1 diabetes program and expect to dose the first patient in the phase I in the first half of 2026. Our balance sheet remains strong at approximately $864 million in cash, providing the flexibility to advance the pipeline. I now ask Ralph to share more about our commercial performance. Ralph?
Ralph Torbay (EVP of Commercial)
Thank you, Bahija. Today I will walk us through KIMMTRAK's full year results and growth opportunities across melanoma. 2025 has been another year of strong commercial execution, marking this our 15th quarter of growth. KIMMTRAK generated $400 million in net revenues for the year, representing 29% YoY growth. This sustained performance reflects KIMMTRAK's position as the global standard of care in first-line metastatic uveal melanoma, with over 70% penetration across all major markets. This breadth of adoption is a testament to KIMMTRAK's transformative long-term impact, with 1 in 4 patients alive at 3 years, an unprecedented milestone in this disease. Mean duration of therapy remains impressive at 14 months, as Bahija mentioned. Continuing the theme of KIMMTRAK's delivering exceptional results, we recently presented real-world data at ESMO IO from 150 patients, showing a median overall survival of 28 months.
We plan to build upon this data with U.S. real-world evidence to be published this year. We also expect to share the 5-year overall survival from our registrational clinical trial, which will further support KIMMTRAK's long-term benefit. Now, as we enter our fifth year on the market, we expect moderating growth through continued commercial execution, further global expansion, and increased penetration in the U.S. community setting. Speaking of the community, KIMMTRAK's adoption is widespread, as evidenced by 70% of all KIMMTRAK prescriptions come from the community. Half of all patient starts happen in the community, and in 2025 alone, we activated 150 new accounts, most in the community. This broad adoption is important because it speaks to KIMMTRAK's value proposition of unprecedented survival and manageable safety. It also brings KIMMTRAK closer to home for many patients who live in less dense geographic areas.
Lastly, it creates a wide foundation for a potential next indication, where half of all patients with cutaneous melanoma are treated by physicians experienced with KIMMTRAK. I'm very excited by KIMMTRAK's midterm growth potential. Today, we're serving approximately 1,000 patients per year in metastatic uveal melanoma, which delivered $400 million in net sales in 2025. When you look across the horizon, the opportunity is up to 6x larger with our two phase III lifecycle management trials. The first one, TEBE-AM, the only randomized phase III study in advanced melanoma, with an overall survival endpoint that could transform the lives of up to 4,000 patients. Second, ATOM, in adjuvant uveal melanoma that could help up to 1,000 additional patients. I'm confident in our ability to execute on this growth trajectory, I'm excited about what's ahead for KIMMTRAK and patients we serve.
I'll now hand over to Mohamed to discuss these trials in more detail, as well as our expanding pipeline.
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Thank you, Ralph. I'm delighted to join this executive team and look forward to sharing the developments across our clinical programs. At Immunocore, we have built a truly unique and diversified TCR pipeline that now spans three therapeutic areas, and I'm pleased to walk you through our progress today. Our R&D engine has delivered a robust portfolio anchored by three ongoing phase III trials in oncology, with data readouts beginning as early as the second half of 2026, with TEBE-AM. Beyond our late-stage efforts, we look forward to new insights maturing this year across our early-stage oncology and infectious disease programs. In autoimmune, 2026 marks a pivotal milestone for our platform as we initiate our first clinical experience. I'll now begin by highlighting our three registrational melanoma trials, starting with TEBE-AM. Our first opportunity is in advanced cutaneous melanoma, where there is a high unmet need.
No therapy has been proven to extend survival in the second-line plus cutaneous melanoma setting, following checkpoint inhibitors and targeted therapy. 1-year overall survival in this setting is approximately 55%. In first-line, patients 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, there remains a large unmet need. Chemotherapy, retreatment with prior therapies, and clinical trials remain the primary options. The only new therapy approved in this setting is TIL therapy, which was based on response rate under accelerated approval, not overall survival. TEBE-AM is the first phase III trial aiming to demonstrate an overall survival benefit, the gold standard in this population. If TEBE-AM is positive, KIMMTRAK would be the first new therapy with overall survival benefit in the second-line plus cutaneous melanoma setting.
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 supported by promising phase I-B data, showing a 75% 1-year survival rate compared to the 55% benchmark. Beyond efficacy, KIMMTRAK is an off-the-shelf therapy with a predictable and manageable safety profile that is already familiar to the melanoma community. We remain on track and project to complete enrollment in the first half of 2026, with top-line data expected as early as the second half of this year. Turning to our second registrational trial. ATOM is the only active registrational phase III trial in the adjuvant uveal melanoma setting, where there is currently no approved standard of care.
High-risk patients are randomized to either KIMMTRAK or observation, with recurrence-free survival as the primary endpoint. The study, sponsored by the EORTC, is currently activated across multiple European countries and is expected to begin site activations in the US during the first half of 2026. Our goal is to bring the benefit of KIMMTRAK to patients earlier, potentially delaying or even eliminating the onset of metastatic disease. As evidence of our robust R&D engine, we now turn to our third registrational opportunity with melanoma, this time leveraging our TCR targeting PRAME, known as brenetafusp. PRISM-MEL is a randomized phase III trial in first-line cutaneous melanoma, comparing brenetafusp plus nivolumab versus either nivolumab monotherapy or Opdualag, with progression-free survival as the primary endpoint.... In November 2025, in line with the FDA's Project Optimus, the IDMC completed the dose selection process, choosing the highest dose to move forward.
We have successfully activated over 200 sites globally and are targeting enrollment completion in 2027. I will now outline how we are strategically applying our platform to address a broader range of high unmet need tumor types. Beyond cutaneous melanoma, we are focused on expanding the PRAME franchise into other tumors, specifically ovarian and non-small cell lung cancer. In ovarian, we are building on the monotherapy activity observed in late line settings by moving into earlier lines of treatment. This includes evaluating brenetafusp in combination with chemotherapy in platinum-resistant ovarian cancer and in combination with bevacizumab in the platinum-sensitive maintenance setting. For lung cancer, our efforts are focused on signal detection across various combinations, including chemotherapy and osimertinib. We expect to present the data from these ovarian and lung cohorts in the second half of 2026, which will inform next steps.
In parallel, we are advancing our PRAME half-life extended candidate, which is currently in dose escalation. 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. We expect to have a comprehensive data package by the second half of 2026 to determine the optimal path forward for the franchise. The modular nature of our platform allows us to expand our reach beyond oncology and unlocks significant growth opportunities in infectious disease and autoimmune. At CROI early last year, we presented initial data from 16 patients enrolled into the multiple ascending dose portion of our HIV study. Two important findings emerged. First, the treatment was well tolerated, and second, we observed a dose-dependent antiviral effect.
At the 60 microgram target dose, you can see that when we stop both our compound and the antiretroviral regimen, viral rebound occurs rapidly. However, at the 120 and 300 microgram target doses, we observe a delay in viral rebound, note the orange lines, providing preliminary clinical evidence that we are impacting the viral reservoir, which is the critical first step toward achieving a functional cure. The clinical data gathered so far confirms the potential of our platform in infectious disease. We are continuing to evaluate higher doses in this study, and we expect to have data from the ongoing dose escalation in the second half of 2026. Now, turning to our third and newest therapeutic area. Our vision for treating autoimmunity is unique.
We aim to achieve tissue-specific down modulation of the immune system, thereby avoiding the risks associated with systemic immune suppression, which is the current approach taken in the field. We are currently advancing two autoimmune candidates. The first is IMC-S118AI, which targets the beta cells in the pancreas in patients diagnosed with type one diabetes. The second is IMC-U120AI, which targets CD1A on Langerhans cells, specialized antigen presenting cells in the skin for the treatment of atopic dermatitis. Today, I'm going to focus on our type one diabetes program, which represents the first clinical test of our tissue-tethered PD-1 agonist approach. We chose type one diabetes because of the profound unmet medical need, with 50,000 patients newly diagnosed every year and data supporting the role of T cells as one of the key mediators of the disease.
Our candidate, IMC-S118AI, binds to preproinsulin, which is expressed exclusively on the beta cells of the pancreas. We have already generated compelling ex vivo proof of concept data using pancreatic slices from human donors. We demonstrated that IMC-S118AI binds specifically to beta cells, as shown in the middle panels, and successfully rescues them from T cell-mediated killing, as seen in the graph on the far right. Importantly, these rescued beta cells remain functional and continue to secrete insulin. Following our CTA filing in December 2025, we are now poised to move into the clinic this year. Our phase I study is designed to provide early evidence of target engagement and immune modulation. To recap, we have a robust, diversified pipeline with important readouts later this year, and our R&D teams remain focused as we continue to advance our platform across all three therapeutic areas.
I will now hand the call to Travis to discuss our financial results.
Travis Coy (CFO and Head of Corporate Development)
Thank you, Mohammed. Good morning. Good afternoon, everyone. Earlier today, we released our financial results for the fourth quarter and year ended 2025. Please refer to the press release and our latest SEC filing on Form 10-K for our full financial results. Let me share some of our key financial highlights for 2025 and then touch upon our expectations for 2026. We are pleased to report strong performance for KIMMTRAK, with full-year net sales reaching $400 million. This represents a 29% increase over 2024, with volume-driven growth across the U.S., Europe, and international regions. Looking ahead to 2026, as we enter KIMMTRAK's fifth year on the market with significant penetration across all major markets, we naturally expect growth to moderate. Our underlying sequential quarterly revenue growth has been in the range of 4%-7% the last few quarters.
We are seeing that growth slow down and expect that trend to continue in 2026. Moving from revenue to expenses, as we continue to maximize global access to KIMMTRAK and advance our pipeline, our operating expenses increased. The increase in our R&D spend versus last year was primarily driven by ongoing investments in our three phase III trials and by advancing our earlier stage programs, including preparations to initiate clinical studies with our autoimmune candidates. In 2026, as we continue to invest in our pipeline, we expect R&D expenses to increase modestly year-over-year, although at a slower rate than they did in 2025. Turning to SG&A, 2025 expenses were marginally higher versus 2024, as we remained disciplined with the spending. In 2026, we expect only incremental increases to these investments, driven by commercial preparations for the potential expansion of KIMMTRAK into cutaneous melanoma.
Overall, we are pleased to have reduced our operating loss in 2025, as revenue grew more than our operating expenses. Our balance sheet remains exceptionally strong. As of year-end, we had $864 million in cash and marketable securities, an increase of more than $40 million versus last year. Our robust financial position, combined with data-driven investments and expense discipline, provides us with the flexibility and resources to continue advancing our mission of delivering transformative medicines to patients. I'll now turn the call back to Bahija Jallal.
Bahija Jallal (CEO)
Thank you, Travis. Thank you, team. Four years ago, we launched the first-ever approved therapy for metastatic uveal melanoma. Today, we're a commercial-stage biotech with a validated platform, three phase III trials, and we are expanding into infectious disease and autoimmunity. We're not just treating cancer, we're also redefining what's possible with T-cell receptor biology. 2025 was a year of execution, and 2026 will be a year of data and continued progress. We thank you all for your support, and now we'll be happy to take your questions. Thank you.
Operator (participant)
Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, 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 would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. We ask that you please limit yourself to one question. One moment, please, while we poll for your questions. Our first question comes from the line of Michael Yee with UBS. Please proceed with your question.
Michael Yee (Senior Pharma and Biotech Analyst)
Hey, guys. Good morning. Congrats on all the progress. I have a quick question on TEBE-AM. I think that's a really exciting opportunity. The data's coming soon. Can you remind me the general geographic breakdown of your enrollment? Is it half US or Europe, et cetera, et cetera? I think there's much more limited agents outside the US, and that could impact the control arm. Secondly, you are designed it such KIMMTRAK and also KIMMTRAK plus PD-1. Did you go through a DSMB analysis or a look to test that KIMMTRAK alone is probably doing at least as good as the combo? What insight did you have on that? Thank you.
Bahija Jallal (CEO)
Great. Mohammed, you want to take that?
Travis Coy (CFO and Head of Corporate Development)
Sure. Thanks, Michael, for the questions. With regards to enrollment on TEBE-AM, the majority of our enrollment is coming from Europe. You know, in line with other recently completed pivotal trials, we expect between 10% and 15% from U.S. and then the rest from the remaining countries. With regards to your question around DSMB and whether we had them look at activity within mono versus combo, as you recall, the original Tevi design was a phase II, III design. Based on enrollment metrics, we converted it all into a phase III seamless, a single consolidated trial design. We'd never looked at the data, neither did the IDMC, this is based purely on enrollment metrics, and as a result, we saved 1 year in terms of the conduct of the phase III trial.
Michael Yee (Senior Pharma and Biotech Analyst)
Got it. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of Tyler Van Buren with TD Cowen. Please proceed with your question.
Tyler Van Buren (Managing Director and Senior Equity Research Analyst)
Hey, guys. good morning. Thanks for taking the question. Just another on TEBE-AM, given how important the readout is in the second half. Can you just remind us what both treatment arms are powered for on overall survival and what you believe the likelihood is that the monotherapy arm, in addition to TEBE plus pembro combination, could succeed?
Bahija Jallal (CEO)
Yes, Mohamed.
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Thank you for the question, Tyler. With regards to the, you know, the statistical assumptions, we usually don't get into the details, but it's fair to say that we've designed the study to basically meet both the statistically significant and clinically meaningful threshold difference from the control. That, you know, in my experience, on average, that's at least a 30% difference from the control.
... With regards to, you know, assumptions between mono and combo, again, we typically don't get into, like, you know, our details of the statistical plan, but needless to say, our data from 201 was based on combo. Certainly logic would support, like, the combo may outperform the mono, but, you know, that's what I can say.
Operator (participant)
Thank you. Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please proceed with your question.
Eric Schmidt (Senior Biotech Analyst)
Thanks for taking my question. Maybe to switch gears a little bit, to, toward Ralph and Travis. It feels like we've been talking about or guiding to deceleration in contract sales for years now. Yet growth has been pretty robust, as you guys called out, 25 ish%+ YoY. I hear you, Travis, that you're thinking that quarterly growth rate is gonna come down from 4%-7%. Do you have a value in mind that you think is realistic, that is substantially less than 25%?
Travis Coy (CFO and Head of Corporate Development)
Yeah, Eric, thanks for the question. Obviously, we're pleased that we continue to overperform commercially, so we're excited about that. You know, we're now entering the 5th year on the market, so we do naturally expect that growth to begin to moderate with significant penetration across all major markets, both U.S. and in Europe. You know, one thing to keep in mind, that year-on-year growth of 29%, we did have some rebate reserves in 2024 and in 2025. If you normalize for those rebate reserves, our underlying growth was around 20%. I just offer that up as a reminder to folks, so you have a little bit better understanding of where we expect growth to moderate from.
Eric Schmidt (Senior Biotech Analyst)
Thank you. I see you have operated around cash flow break even in 2025. Is that a reasonable estimate for 2026?
Travis Coy (CFO and Head of Corporate Development)
You know, we continue to focus on investment in our three phase IIIs. We do expect R&D expenses to modestly increase into 2026 from 2025. You know, and from an SG&A perspective, we've been really pleased with how well we've managed those expenses and continue to be disciplined on that front. We've been very consistent, really, over 2024 and 2025, around that $40 million mark per quarter, and only expect, you know, incremental increases into 2026 as we prepare for cutaneous melanoma.
Eric Schmidt (Senior Biotech Analyst)
Thank you very much.
Operator (participant)
Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question.
Jack Allen (Senior Research Analyst)
Great. Thanks for taking the questions. Congrats to the team on the updates. I wanted to ask a little bit on the commercial outlook. You know, pending positive results in the TEBE-AM study, I wanted to ask the team how they thought about pricing in that indication. I know you have a very meaningful price in metastatic uveal melanoma, which is a rarer space. How do you think about the larger second-line cutaneous melanoma market and any impact on price moving forward there, pending a launch into that indication?
Bahija Jallal (CEO)
Thank you.
Ralph Torbay (EVP of Commercial)
Thanks, Jack, for the good question. When you consider the unmet need that exists today in advanced melanoma, and the fact that we have a phase III with an overall survival endpoint, and the fact that we're, you know, we have an established safety and this is an off-the-shelf treatment. Really, if the data is positive, and this is all data dependent, we believe that, you know, we can potentially defend that price appropriately, given the OS endpoint. Of course, data dependent.
Jack Allen (Senior Research Analyst)
Great. Thanks for the call.
Operator (participant)
Thank you. Our next question comes from the line of Sean Laaman with Morgan Stanley. Please proceed with your question.
Sean Laaman (Executive Director)
Good morning, everyone. Hope everyone's well, and thank you for taking my question. I have a question on your autoimmune entry. First candidate entering phase I in 2026. How do you evaluate success in the early autoimmune studies relative to oncology benchmarks? How capital-intensive could the platform become? Thank you.
Bahija Jallal (CEO)
Thank you for this question. I'll take that. You know, we chose Type 1 diabetes exactly for that reasons that we can determine very early on. Two questions that we'll answer right away, you know, does the drug bind the target? That we will look at that with the soluble PD-1, for instance, and other things. The second is, you know, we do have the surrogate C-peptide that we can measure. Once we have the dose, we can measure that, and that's a surrogate for efficacy. Exactly that we can find out basically early on if this has the potential to be active or not. That's really the reasoning before we engage into big phase II-Bs or something like that.
Sean Laaman (Executive Director)
Wonderful. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of Jonathan Chang with Leerink Partners. Please proceed with your question.
Jonathan Chang (Senior Research Analyst)
Hi, guys. Thanks for taking my question. How are you thinking about the learnings from the success of KIMMTRAK in uveal melanoma, and how could those apply to a potential commercial launch in cutaneous melanoma? What similarities and differences are you considering? Thank you.
Bahija Jallal (CEO)
Yeah, great question. Ralph, you want to take that?
Ralph Torbay (EVP of Commercial)
Sure, Jonathan, thank you for the question. We in cutaneous melanoma, you have half of these physicians treating patients who, half of the patients with cutaneous melanoma are being treated by physicians who are experienced with KIMMTRAK today. This is a great foundation upon which we will build. In addition to that, the team, you know, is very well trained, has executed recently on the launch. You know, has a track record of successful launches. All of this together will lead into, I think, a good data dependent, of course, potential launch.
Bahija Jallal (CEO)
A strong medical team. I think that's, you know, following with the science.
Jonathan Chang (Senior Research Analyst)
Got it. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of Graig Suvannavejh with Mizuho Securities. Please proceed with your question.
Graig Suvannavejh (Managing Director)
Thanks for taking my question, congrats on the progress. I was curious about your PRAME portfolio. You've got several different programs going on there, I'm wondering, you've got a lot of combinations for lung cancer and also ovarian cancer. I'm wondering what are the different scenarios that we could see coming out of the company when we get that data update in the second half? Would you be willing to share if you would be advancing potentially two assets if you had good data? Is the view that there's going to be one asset coming out of that pipeline review? Any color there on how you're thinking about what the outcome could be of that update in the second half?
Bahija Jallal (CEO)
Yeah, before I leave it to Mohammed, I'll just say this is a typical, you know, a phase I exploration, phase I-B that we are doing, especially when you know that the target is validated, and I think to just address a lot of questions in the early phase before engaging in a late phase, at least when it comes outside of melanoma. Mohammed, do you want to comment?
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Sure. Thanks. Thanks, Graig, for the question. Look, I think, you know, we're in a unique position where we've been in the clinic with Brenni for several years, and we've now enrolled several hundred patients. We're certainly mining that data, which will help guide next steps for the Brenni program. In addition, as Bahija mentioned, we have the PRAME HLE trial that's ongoing, and so we're gonna be in a good position by the end of the year to look at the totality of the data to guide us with regards to the next steps. It just provides us optionality, basically.
Operator (participant)
Thank you. Our next question comes from the line of Rajan Sharma with Goldman Sachs. Please proceed with your question.
Rajan Sharma (Pharma and Biotech Equity Research)
Hi, thanks for taking my question. Just one on the HIV program that we're expecting an update for later this year. Could you just maybe frame expectations there in terms of number of patients that we should expect that data set to be in? Maybe if you could just talk to how high you think you can push the dose there. Thank you.
Bahija Jallal (CEO)
Yeah. Mohammed, do you want to take that?
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Sure. Thanks, Rajan, for the question. Just as a reminder, obviously, the HIV trial is in, you know, multiple ascending dose portion. We shared data last year that showed early dose-dependent effects, so we're continuing to escalate. It's still a phase I dose escalation, so cohorts are, you know, small sizes, but we anticipate by the end of this year to be able to identify the right dose and look at the impact on the viral reservoir as well as the viral rebound. The other part of the study is that we can trigger expansion based on the data that we see, and so that can allow us to build on any signals we see during dose escalation.
Operator (participant)
Thank you. Our next question comes from the line of Faisal Khurshid with Jefferies. Please proceed with your question.
Faisal Khurshid (Analyst)
Hi, guys. Thank you for taking the question. Just wanted to ask, how are you thinking about the upcoming competitor readout in frontline uveal from IDEAYA? I understand it's HLA negative, but, you know, do you think there could be any read-through or any impact to your stronghold, in frontline HLA positive uveal? Thank you.
Bahija Jallal (CEO)
Ralph, do you want to take it?
Ralph Torbay (EVP of Commercial)
Sure. Faisal, thank you for the question. Look, we need to see some randomized phase III data from the competitor. Currently, we've seen only 42 patients, with 11 of those patients being HLA-A*02:01 positive. What I'll be personally looking for, in addition to response rate, of course, is the hazard ratio, because standard of care has evolved since the beginning of that trial. The safety, because small molecules can have tolerability challenges. We've seen in other indications. Those are the two points that I'll be looking for in the data readout.
Bahija Jallal (CEO)
We are very much confident that, KIMMTRAK is standards of care with very robust data from... not only from the clinical trials, but also from the real-world evidence, and will bring a five-year evidence basically that's extending life of patients.
Faisal Khurshid (Analyst)
Great. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of James Shin with Deutsche Bank. Please proceed with your question.
James Shin (Equity Research Analyst)
Hey, good morning, guys. Thank you for the question. One for Mohammed. I'm gonna follow up on the TEBE-AM question on geographic breakdown. Can you lay out the percentage mix in the control arm, as in what % may be on TILs versus recycled PD-1s, and whether that mix may impact, like, historic OS levels? Thank you.
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Yeah, thanks.
Thanks, James, for the question. No, it's a really important question. It's one that we've obviously been thinking about throughout the conduct of the study. What I can tell you is that we've looked at recent real-world data, and that confirms our original assumptions, that about a third of the patients likely in the control arm will get retreated with checkpoint. Those that are BRAF mutant typically get retreated with a BRAF-based regimen, the remaining are treated with chemotherapy or clinical trial, reflecting the high unmet need and the lack of an accepted standard. In terms of TIL, your question, as I mentioned in my original response to Michael, a majority of the patients are being enrolled in Europe, where TILS are not approved.
you know, I think we remain confident in the original assumptions of our trial regards to control.
Operator (participant)
Thank you. Our next question comes from the line of Paul Jeng with Guggenheim Securities. Please proceed with your question.
Paul Jeng (VP of Biotechnology Equity Research)
Great. Thanks for taking the question. I wanted to ask about the second-line cutaneous melanoma opportunity for KIMMTRAK and how you view the evolving landscape, maybe 2-3 years down the road, where there could be some other therapies on the market, including for the HLA-positive segment. Where do you sort of see KIMMTRAK fitting into that paradigm in the future? Are there any factors like patient baseline characteristics or sites of care that could drive more utilization for KIMMTRAK versus some of those competing therapies? Thank you.
Ralph Torbay (EVP of Commercial)
Paul, I can start, of course, Mohammed, you can add to this. Currently, the only approved therapy in that line of therapy is of treatment is TILS. Of course, that is highly selective of patients because of, you know, the entire process that patients have to undergo through. Similarly, you mentioned the HLA-II positive TCRT. That is also a highly selective patient population. Of course, you know, KIMMTRAK will have an OS endpoint, right? Keep in mind, TILS and the TCRT will have response rate, potentially PFS endpoints. We'll have an overall survival endpoint, which is the golden standard at that indication. Importantly, we're off the shelf. We'll have also long-term safety already in melanoma patients, obviously, uveal melanoma.
Importantly, we have a great base of experience. We have half of the cutaneous melanoma patients are being treated in centers that are experienced with KIMMTRAK. All of this together, I think, gives us a significant leg up in this setting. You can go on.
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Yeah, the only other thing I would add is that ultimately it's good for patients, you know, in a setting where there's no high unmet need and no options, it's good for patients to have options. Ultimately, I think what drives physician choices is based on the data. As Ralph mentioned, our trial is a randomized phase III trial looking at OS, which is the gold standard. I think, you know, the data will drive ultimate practice.
Operator (participant)
Thank you. Our next question comes from the line of Eva Fortea with Wells Fargo. Please proceed with your question.
Eva Fortea (Biotech Equity Research Analyst)
Good morning. Thanks for taking our question, and congrats on the progress. A quick one from us, just on brenetafusp. I guess, what do you need to see in the upcoming ovarian and lung results to move forward in development? Are you looking for anything specific in terms of efficacy? Thanks.
Bahija Jallal (CEO)
Mohamed, you want to say?
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Sure. Thanks, thanks, Eva, for the question. You know, as I mentioned earlier, we've been in the clinic for now a number of years and treated several hundred patients. We already have seen a clear signal of activity in ovarian. We shared that data in 2024 at ESMO. There obviously wasn't a clear line of sight for monotherapy accelerator approval, so we pivoted to earlier lines, the maintenance setting, which we believe plays to the strength of the platform, which is disease control and a very favorable safety profile. The data that we're planning to share will be predominantly safety cohorts, so smaller than the monotherapy data we shared earlier, but focused on safety and potentially early signals in this maintenance setting. Lung, we're still signal-searching.
This is a heterogeneous population. The data that we're planning to share will include a data set that's similar to what we've shared with ovarian and melanoma, but it's across multiple heterogeneous subsets. Of course, we have safety cohorts looking at chemo combo and osimertinib. Ultimately, Eva, what I would say is that it's going to be the totality of the data. In addition, we have the PRAME-HLA. We'll look at the total data to help guide our next steps.
Operator (participant)
Thank you. Our next question comes from the line of Romy O'Connor with Van Lanschot Kempen. Please proceed with your question.
Romy O'Connor (Analyst)
Hi, team. Thank you for taking my question. Maybe just backing on to Eva's here, focusing on the PRAME half-life extended. I just want to ask, if you can point us to what we need to see here to inform any major changes to the PRAME program in totality. You mentioned, convenience and improved response. Should we be benchmarking this against, what brenetafusp has already shown? Thank you.
Bahija Jallal (CEO)
Great question. Mohammed?
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Sure. Thanks, Roni, for that question. Yeah, no, exactly. I mean, you know, as we said, we're in a very good position where we have our brenetafusp data. Essentially, PRAME-HLA is Brenni with FC added on. You know, we're doing the right experiment in the clinic, asking those two basic questions. Based on the data, it will provide us optionality in terms of which molecule to carry forward in which setting.
Bahija Jallal (CEO)
Yeah, I think when we started is really look at convenience, because, you know, we see with KIMMTRAK, with short half-life, and amazing has a ratio of 0.551. I think, you know, with other data out there, if we see also an increase in ORR or something like that, then I think that's what Mohammed was talking about, is looking at the totality of the data, and then we'll determine, you know, the next steps. We'll do the experiments, and we'll get the data.
Romy O'Connor (Analyst)
Great. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of Patrick Trucchio with H.C. Wainwright. Please proceed with your question.
Patrick Trucchio (Managing Director and Senior Research Analyst)
Thanks. Good morning. Just a couple of follow-ups on TEBE-AM. I'm just wondering, you know, given the OS primary endpoint, what was the assumed median OS in the control arm, and has anything in the real-world evolution of the treatment landscape changed that assumption since trial initiation? Just separately, just regarding the timing of the data as early as second half 2026, maybe you can give us an idea of what the, you know, events assumptions are driving that and the probability that the data perhaps slips into 2027.
Bahija Jallal (CEO)
Okay, I'll take the second part. Mohammed will take the first part. Because it is an OS endpoint, it is event driven. We'll have a little bit better idea maybe when the trial is done, but it's gonna depend on the event. That's why, you know, just doing the calculations that we did and the assumptions, that will basically, we see it today as early as the second half of 2026. We'll get a little bit better once we finish the trial and depending on the events. Mohammed, you want to take the first part?
Mohammed Dar (EVP of Clinical Development and Chief Medical Officer)
Sure. Thanks for the question, Patrick. With regards to OS assumptions for the control arm in TEBE-AM, the assumptions we made at the start of the trial really haven't changed because ultimately there has been no randomized trial that's actually established an improvement in survival in this setting. Those assumptions essentially were a median overall survival between 12 and 13 months and a 1-year survival rate of around 55%. Things haven't really moved in from that regards.
Patrick Trucchio (Managing Director and Senior Research Analyst)
Great. Thanks so much.
Operator (participant)
Thank you. We have reached the end of our question and answer session. With that, I would like to turn the floor back over to Morgan Morse for any closing comments.
Morgan Morse (Investor Relations Manager)
Thank you for joining us today. We appreciate all of your support.
Bahija Jallal (CEO)
Thank you.
Operator (participant)
Thank you, ladies and gentlemen. This does now conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.
