Q2 2026 Immunocore Holdings PLC Earnings Call

August 6, 2026

Operator 2: Greetings, 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's now my pleasure to turn the call over to Ryan Baker, Vice President, Investor Relations. Ryan, please go ahead.

Operator: Greetings, 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's now my pleasure to turn the call over to Ryan Baker, Vice President, Investor Relations. Ryan, please go ahead.

Speaker #1: Greetings, and welcome to the Immunocore conference call and webcast. At this time, all participants are in the listen-only mode. A question-and-answer session will follow the formal presentation.

Speaker #1: 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 yourself to one question, then return to the queue.

Speaker #1: As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star zero. It's not my pleasure to turn the call over to Ryan Baker, Vice President and Investor Relations.

Speaker #1: Ryan, please go ahead.

Ryan Baker: Morning, good afternoon. Thank you for joining us on our Q2 and H1 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 H1 2026. Ralph Torbay, Chief Commercial Officer, will review our Q2 H1 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: Morning, good afternoon. Thank you for joining us on our Q2 and H1 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 H1 2026. Ralph Torbay, Chief Commercial Officer, will review our Q2 H1 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.

Speaker #2: 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.

Speaker #2: Please note that actual results can vary materially from those indicated by these forward-looking statements, including those discussed in our morning and other filings with the SEC.

Speaker #2: 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 and first-half ChemTrack results, as well as recently published five-year overall survival data.

Speaker #2: Dr. Mohamed Dar, our Chief Medical Officer, will provide a pipeline update. And Travis Coy, our some key highlights from our financial results reported earlier this morning.

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

Speaker #2: Bahija Jallal.

Speaker #3: Good morning, and good I will now turn the call over to Dr. 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.

Bahija Jallal: Good morning, good afternoon, 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. 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, expanding into other tumor types, and realizing opportunities in infection and autoimmune diseases. Starting with KIMMTRAK, we generated $223 million in net revenue in H1 of the year, representing 16% growth compared to H1 2025. At AACR 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.

Speaker #3: 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 ChemTrack, advancing our melanoma portfolio, and expanding into other tumor types, and realizing opportunities in infection and autoimmune diseases.

Speaker #3: Starting with ChemTrack, we generated 223 million in net revenue in the first half of the year, representing 16% growth compared to the first half of 2025.

Speaker #3: At ASCR in April, we presented the five-year overall survival data that showed that ChemTrack doubles the likelihood of being alive at five years for patients with HLA-A2 positive metastatic uveal melanoma.

Speaker #3: 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.

Bahija Jallal: For a disease once measured in months, 5 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 PIWIL1 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.

Speaker #3: In melanoma, we are advancing three ongoing phase three trials. To be AM, ATOM, and PrismMEL 301. An important differentiator for a company of our size.

Speaker #3: Beyond melanoma, we expect to present updated PRAME data in additional tumor types by the end of the year, and to provide initial PWIL data in 2027.

Speaker #3: 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.

Speaker #3: Finally, in HIV, we have completed enrollment of additional patients at higher dose cohorts, up to 1.2 mg, as part of the multiple ascending dose portion of the Phase 1/2 study, and plan to share results early next year.

Bahija Jallal: 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?

Speaker #3: 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.

Speaker #3: Ralph?

Speaker #2: Thank you, Bahija. Today, I will cover ChemTrack’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 16% year-on-year growth and reflecting the sustained strength of ChemTrack across our global markets.

Ralph Torbay: Thank you, Bahija. Today, I will cover KIMMTRAK's continued commercial momentum, our landmark 5-year OS data, and our ongoing growth opportunities across melanoma. We delivered $223 million in net sales during H1 2026, representing a 16% year-on-year growth, and reflecting the sustained strength of KIMMTRAK across our global markets. In Q2, 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 US 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.

Speaker #2: In the second quarter, we generated 116 million in net sales, with the US contributing 75 million and serving as the primary growth driver. The strong performance was supported by continued demand growth in the community, as well as 6 million in inventory stocking by US distributors.

Speaker #2: 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, and a stable duration of therapy of 14 months.

Speaker #2: In our fifth year on the market, we expect moderating growth, driven by continued commercial excellence, geographic expansion, and deeper penetration in the US community setting.

Ralph Torbay: In our fifth year on the market, we expect moderating growth driven by continued commercial excellence, geographic expansion, and deeper penetration in the US 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 5-year survival data from our registrational trial, which I will discuss in slide eight. KIMMTRAK's landmark 5-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 5 years with a 16% OS rate compared with 8% for investigators' choice.

Speaker #2: The body of evidence supporting the long-term survival benefit for patients treated with ChemTrack 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.

Speaker #2: ChemTrack's landmark five-year data sets the bar for overall survival in HLA-O21 positive first-line metastatic uveal melanoma. It is also the longest OS follow-up ever reported in a randomized metastatic uveal melanoma trial.

Speaker #2: And for any T-cell engager in a solid tumor. This data shows that treatment with ChemTrack doubles the likelihood of survival at five years, with a 16% OS rate compared with 8% for investigators' choice.

Speaker #2: Importantly, the survival curve separated early and remained separated over time. In the active arm, 44% of patients alive at five years received ChemTrack as their only treatment.

Ralph Torbay: Importantly, the survival curve separated early and remained separated over time. In the active arm, 44% of patients alive at 5 years received KIMMTRAK as their only treatment. In the control arm, 87% of patients alive at 5 years crossed over to KIMMTRAK. Remarkably, only a single patient that did not cross over to KIMMTRAK was alive at 5 years. The 5-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 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.

Speaker #2: In the control arm, 87% of patients alive at five years crossed over to ChemTrack. Remarkably, only a single patient that did not cross over to ChemTrack was alive at five years.

Speaker #2: The five-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.

Speaker #2: 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 lifecycle management program, which I will discuss on the next slide.

Speaker #2: 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 three lifecycle management trials.

Ralph Torbay: 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. 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?

Speaker #2: To be 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.

Speaker #2: 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.

Speaker #2: I'll now hand over to Mohamed, to discuss these trials in more detail. Mohamed?

Speaker #4: 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 To be AM on slide 12.

Mohammed Dar: 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 1-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.

Speaker #4: 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.

Speaker #4: With one year overall survival in this setting remaining unchanged at approximately 55%. To be AM is the first phase three trial aiming to demonstrate an overall survival benefit, the gold standard in this setting.

Speaker #4: If To be AM is positive, ChemTrack 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.

Speaker #4: In second line, patients can switch between these classes where appropriate. Beyond second line, retreatment with prior therapies chemotherapy and clinical trials remain the primary options.

Mohammed Dar: 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% 1-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.

Speaker #4: The only recently approved therapy under accelerated approval in this setting is TIL therapy based on response rate, not overall survival. As a reminder, To be AM is a randomized phase three trial for melanoma patients who have progressed on checkpoints and, if applicable, targeted therapy.

Speaker #4: Patients are randomized to ChemTrack monotherapy, ChemTrack 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 one B data showing a 75% one-year survival rate compared to the historical benchmark of 55%.

Speaker #4: Beyond efficacy, ChemTrack 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 teens.

Mohammed Dar: 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. Now turning to our second KIMMTRAK LCM registrational trial. To date, 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 US. 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.

Speaker #4: With top-line data still expected as early as the end of this year. Now turning to our second ChemTrack LCM registrational trial. To date, ATOM is the only uveal melanoma registrational trial actively enrolling in the adjuvant setting, where there is currently no approved standard of care.

Speaker #4: High-risk patients are randomized to either ChemTrack or observation, with relapse-free survival as the primary endpoint. The study, sponsored by ERTC, has been enrolling patients across multiple European countries and is now enrolling in the US.

Speaker #4: Our goal is to bring the benefit of ChemTrack to uveal melanoma patients earlier, potentially delaying or even eliminating the onset of metastatic disease. Our third registrational opportunity is also in melanoma.

Speaker #4: This time with BRNATAFUS, our TCR targeting PRAME. The PRISM L301 trial is a randomized Phase 3 trial in first-line cutaneous melanoma, comparing BRNATAFUS plus nivolumab versus either nivolumab monotherapy or nivolumab plus relatlimab, with progression-free survival as the primary endpoint.

Mohammed Dar: 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 pretreated 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 pretreated patients with advanced melanoma.

Speaker #4: We have now successfully activated over 200 slides globally, and our targeting enrollment completion by late 2027. Next, I will briefly cover the phase one two trial with BRNATAFUS in heavily pretreated patients with advanced melanoma presented recently at ASCO.

Speaker #4: These data reinforce our belief in the potential of BRNATAFUS plus Nivo in first-line advanced melanoma. The data demonstrated a 17% overall response rate and a 67% disease control rate with BRNATAFUS monotherapy at the 160 microgram dose in heavily pretreated patients with advanced melanoma.

Speaker #4: 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 three trial in first-line advanced melanoma.

Mohammed Dar: 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 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 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.

Speaker #4: The median overall survival for BRNATAFUS monotherapy in this late-line melanoma population reached 14.3 months. This compares favorably to other phase one two trials of combination therapies in heavily pretreated patients, with advanced melanoma, including recent studies with autologous cell therapies.

Speaker #4: 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.

Speaker #4: 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 BRNATAFUS in combination with chemotherapy in platinum-resistant ovarian cancer, and in combination with bevacizumab in platinum-sensitive maintenance setting.

Mohammed Dar: 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 half-life extended 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: As data become available, we will determine the best next steps for the franchise. The modular nature of our IMTAX platform allows us to expand our reach beyond oncology and potentially unlock significant growth opportunities in infectious disease, and autoimmunity.

Mohammed Dar: The modular nature of our ImmTAX 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 H1 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: Now turning to our third therapeutic area, autoimmunity. Our phase one trial in type one diabetes is now open and actively screening patients, and we expect the first patient to be dosed in the coming weeks.

Speaker #4: 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 one diabetes with 50,000 HLA 0201 positive patients newly diagnosed every year.

Mohammed Dar: 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.

Speaker #4: Our candidate, S118AI, 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.

Speaker #4: We are now turning our focus to our phase one 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 we continue to advance a diversified pipeline across all three therapeutic areas, anchored by our three ongoing phase three trials in melanoma.

Speaker #4: 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.

Mohammed Dar: 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 #1: Thank you, Mohammed. 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.

Travis Coy: Thank you, Mohammed. Good morning, good afternoon, everyone. Earlier today, we released our financial results for Q2 and H1 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 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Travis Coy: 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. 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: This quarter, we had a net loss of just under $1 million. An improvement versus the 10 million loss in the same period of last year.

Travis Coy: 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 30 June, 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 H2 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.

Speaker #1: Our balance sheet remains exceptionally strong. As of June 30, we held $880 million in cash and marketable securities. This is an increase of $16 million since the beginning of the year.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: Our strong balance sheet provides the flexibility to support near-term commercial execution and pipeline advancement. While continuing to invest in a longer-term growth opportunities across our business.

Travis Coy: 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.

Speaker #1: I'll now turn the call back to Bahija.

Speaker #2: Thank you, Travis, and thank you, team. The five-year overall survival data with ChemTrack confirms what it can deliver for HLA-02 positive patients with MUM.

Bahija Jallal: Thank you, Travis, and thank you, team. The five-year overall survival data with Kimmtrak confirms that 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.

Speaker #2: While also confirming the potential of our intax platform. We look forward to sharing the Tabby AM data as early as the end of 2026, which could offer a much-needed treatment option for patients with advanced cutaneous melanoma.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Thank you for your support. And now we'll be very happy to take your questions.

Speaker #3: 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 one on your telephone keypad.

Operator 2: 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 *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press *2 if you'd like to remove your question from the queue. As a reminder, we ask 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.

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 *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press *2 if you'd like to remove your question from the queue. As a reminder, we ask 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.

Speaker #3: 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.

Speaker #3: 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 Calvin.

Speaker #3: Your line is now live.

Speaker #4: Hi there. Good morning. Congratulations on the progress. Thanks for the question. For the TABBY-AM trial, can you please review the study plan for us with respect to the potential interim or interims and a final analysis?

Tyler Van Buren: 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.

Speaker #4: 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.

Speaker #4: Or am I wrong there? And can you help us understand how that is powered? And if there is an interim and a final, how that's powered relative to the final?

Speaker #2: Thank you. Mohammed, you want to take that?

Bahija Jallal: Thank you. Mohammed, do you want to take that?

Speaker #5: Yeah. Good morning, Tyler. Thanks. Thanks for the question. So 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.

Mohammed Dar: Yeah. Good morning, Tyler. Thanks for the question. 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. 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.

Speaker #5: 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.

Speaker #5: 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.

Speaker #5: So, we remain on track for that.

Speaker #3: Thank you. Our next question is coming from Michael Yee from UBS. Your line is now live.

Operator 2: Thank you. Our next question is coming from Michael Yee from UBS. Your line is now live.

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

Speaker #6: Hi. Thanks so much for the question. This is Dina Ahn from 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.

[Analyst] (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, and I think guidance is H1, so 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 percent of the patients do you think would be on a clinical trial versus chemo or IO retreatment? Thanks so much.

Speaker #6: 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 ChemTrack arms are potentially doing better versus the control arm?

Speaker #6: 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?

Speaker #6: Thanks so much.

Speaker #2: Okay. Did you have two parts? I think you can take it.

Bahija Jallal: Okay. You have two parts, I think you can take it, Mohammed.

Speaker #5: Sure. Happy to take those two questions. So 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.

Mohammed Dar: 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 and its overall survival. 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 clinical trials is very low, typically in the single-digit percentage.

Speaker #5: So that's the reason while 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 #3: Thank you. Our next question today is coming from Eric Schmidt from Cancer Pathology. Your line is now live.

Operator 2: Thank you. Our next question today is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.

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

Speaker #6: Hi. This is Imogen on for Eric. Good morning. For the shape of the enrollment curve for Tabby AM, could you just provide a little bit more color on that and how that could lead to the event rates being hit?

[Analyst] (Leerink Partners): 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 PRAME would be reasonable to compare that to?

Speaker #6: Maybe for an interim, or a final analysis later this year, and then as we think about the half-life extended PRAME data coming, could you help us think about expectations there, and which data sets from BRENI would be reasonable to compare that to?

Speaker #5: Happy to take that. So with regards to the Tabby AM enrollment curve, once we reach this is I'm just giving you sort of a general experience, right?

Mohammed Dar: Happy to take that. With regards to the TEBE-AM enrollment curve, 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 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 are 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, so escalation continues.

Speaker #5: 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 Tabby AM trial.

Speaker #5: 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.

Speaker #5: The impact usually comes from patients that are 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.

Speaker #5: With regards to the PRAME 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.

Mohammed Dar: 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 PRAME, so many of the sites that are on the half-life extended were on the PRAME trial, and many of the patient types that were enrolled in PRAME 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.

Speaker #5: So 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 PRAME HLE, mainly melanoma and ovarian.

Speaker #5: So that's the so those are the probably the tumor types that you'd look for to trying to compare across the two trials.

Speaker #2: Yeah. And 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 and so that's why.

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

Speaker #3: Thank you. Our next question today is coming from Jessica Fire from JP Morgan. Your line is now live.

Operator 2: Thank you. Our next question today is coming from Jessica Fye from J.P. Morgan. Your line is now live.

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

Speaker #7: Hi. This is Daniel Ahn for Jess. I had a couple of questions on ChemTrack. We in Tokyo we saw ChemTrack US revenues grew 17% year on year to 75 million.

[Analyst] (J.P. Morgan): Hi. This is Tanay on for Jess. I had a couple of questions on KIMMTRAK. In Q2, we saw KIMMTRAK US 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 US and Europe penetration stand today for KIMMTRAK? If you could provide additional color on split between the academic centers and community penetration in the US, that would be great.

Speaker #7: So does that 17% growth rate fall under your definition of moderate growth that you have repeatedly referred to? And where does the US and Europe penetration stand today for ChemTrack?

Speaker #7: And if you could provide additional color on split between the academic centers and community-driven penetration in the US, that would be great.

Speaker #2: Great. So you were cutting off. So I hope we understood the question. I think there are several parts of the question. So one is on the 17% in the US, is this the moderation?

[Analyst] (Mizuho): 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 US, is this the moderation? Then you can take the next one.

Bahija Jallal: 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 US, is this the moderation? Then you can take the next one.

Speaker #2: And then you can take the next one.

Travis Coy: 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 we're seeing moderating growth.

Speaker #8: Yeah. And I've just started. 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.

Speaker #8: I think you asked about the 17% growth being considered moderate. One of the things to note is 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.

Speaker #8: And that's what we mainly refer to when we say we're seeing moderating growth.

Speaker #2: The penetration in the US versus Europe.

[Analyst] (Mizuho): The penetration in the US versus Europe.

Bahija Jallal: The penetration in the US versus Europe.

Speaker #3: Just to comment on that 17%,

Ralph Torbay: Just to comment on that 17%, Travis. Part of that, what contributed to that 17%, is unusual stocking event that we had in the US 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 US. That includes 70% of our prescriptions coming from the community. In countries in Europe, we're about 75% and 80%. It's very well penetrated across all major markets.

Speaker #7: Travis. The part of that what contributed to that 17% is a stocking unusual stocking event that we had in the US of about 6 million.

Speaker #7: 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 US.

Speaker #7: That includes 70% of our prescriptions coming from the community. And in countries in Europe, we're about 75, 80 percent. So very well penetrated across all major markets.

Speaker #3: Thank you. Our next question is coming from Jack Allen from Baird. Your line is now live.

Operator 2: Thank you. Our next question is coming from Jack Allen from Baird. Your line is now live.

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

Speaker #1: Awesome. Thanks for taking the questions and congrats on the progress over the course of the quarter. I wanted to ask on Tabby 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.

Jack Allen: Awesome. Thanks for taking the questions, 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.

Speaker #1: 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?

Speaker #1: And how are those trending? Any qualitative comments would be helpful.

Speaker #2: Well, how many do you want to take?

[Analyst] (Mizuho): Mohammed, you want to take it?

Bahija Jallal: Mohammed, you want to take it?

Mohammed Dar: 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.

Speaker #5: Yeah, happy to take that question. So, you're correct. I mean, that's very standard as you get close to enrollment completion and are looking forward to potential analysis.

Speaker #5: 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 being able to have headline data as early as the end of 2026.

Speaker #5: As we get closer to that, we can certainly provide an update. Because the zone of uncertainty becomes more narrow.

Speaker #3: Thank you. Our next question is coming from Sean Lomond from Morgan Stanley Investment Management. Your line is now live.

Operator 2: Thank you. Our next question is coming from Sean Laaman from Morgan Stanley Investment Management. Your line is now live.

Operator: Thank you. Our next question is coming from Sean Laaman from Morgan Stanley Investment Management. Your line is now live.

Speaker #8: Good morning, everyone. Hope everyone's well. Just skipping ahead on Tabby AM in 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?

Sean Laaman: 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 3 years of launch?

Ralph Torbay: Sean, thank you for the question. The opportunity here is up to 4,000 patients across US and EU, and this is HLA-0201-positive patients. 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. 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.

Speaker #1: Sean, thank you for the question. The opportunity here is up to 4,000 patients across the US and EU, and this is HLA-020 positive patients.

Speaker #1: 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.

Speaker #1: approved in this setting. And we would be the first off-the-shelf OS-driven therapy. So I expect a good uptake. Especially since we're building from our base where currently 50% of patients with cutaneous melanoma are being treated are being treated by physicians experienced with ChemTrack.

Speaker #1: So, we expect a good uptake based on our incremental impact. There are little to no therapies today.

Speaker #3: Thank you. Our next question today is coming from Ivo Fortea from Wells Fargo. Your line is now live.

Operator 2: Thank you. Our next question today is coming from Eva Fortea from Wells Fargo. Your line is now live.

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

Speaker #9: Hi team. Thanks for taking our question. And congrats on the progress. A quick one from us on ChemTrack. Are you seeing patients getting diagnosed a little bit earlier in disease prevent by the availability of ChemTrack now for five years in the market?

Eva Fortea: 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 5 years in the market? Are the numbers still what you were expecting 5 years ago? Thanks.

Speaker #9: Or are the numbers still what you were expecting five years ago? Thanks.

Ralph Torbay: 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 would see before, and this is across most countries.

Speaker #7: 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.

Speaker #7: 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.

Speaker #7: The hazard ratio for these patients was 0.36. So we do see a little bit of a more systemic monitoring of these patients, more so than we could see before.

Speaker #7: And this is across most countries.

Speaker #3: Thank you. Our next question is coming from Greg Zavanovic from Mizuho. Your line is now live.

Operator 2: Thank you. Our next question is coming from Graig Suvannavejh from Mizuho. Your line is now live.

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

Speaker #10: Hi there. This is John for Greg. Thanks for taking my question. Quick one on the brunetifus phase one, two studies in ovarian cancer and non-small cell lung cancer.

[Analyst] (Mizuho): Hi there. This is Doug on for Greg. Thanks for taking my question. Quick one on the brenetafusp phase I/II studies in ovarian cancer and non-small cell lung cancer. What we should be expecting to come from that data, how robust the data sets. Are these 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? Would they go after different populations? Is it just way too early to tell?

Speaker #10: Just sort of like what we should be expecting to come from that data, how robust the data sets are these ORR numbers that are really going to help you sort of choose what indications to pursue in advance?

Speaker #10: And then first part of the question, then as a follow-up on brunetifus 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 with a compete with each other with half-life extended if all goes according to plan sort of replace brunetifus?

Speaker #10: Or would they go after different populations? Or is it just way too early to tell?

Speaker #5: Happy to take on the two questions. With regards to the expected ovarian and lung data from the phase one, two trial, with ovarian, we already saw an initial signal in late-line platinum resistant ovarian cancer about two years ago.

Mohammed Dar: 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 2 years ago. We're building on that. There should be two parts to that. One is longer follow-up of that original monotherapy cohort. We can look at survival, which was not mature 2 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. This will be a safety size cohort where we're looking at initial safety and feasibility, also we'll have the ability to look at initial clinical activity.

Speaker #5: 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.

Speaker #5: And since then, we've pivoted to earlier lines and are looking at combinations with standard cure, especially bevacizumab in the platinum-sensitive maintenance setting. But this will be a safety-sized cohort where we're looking at initial safety and feasibility, but also we'll have the ability to look at initial clinical activity.

Speaker #5: 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 substances.

Mohammed Dar: 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.

Speaker #5: As you know, lung is quite heterogeneous. And then we have safety-sized 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, brunetifus is already in the frontline PRISM-MEL study, and we have full confidence in that trial.

Speaker #5: HLE, because it at minimum offers patient convenience, could certainly be positioned for early lines of therapy where that becomes important, such as adjuvant setting.

Speaker #5: And then, of course, there are other diseases like ovarian and lung that we haven't—we're going to compare the data to help guide next steps.

Speaker #2: So you want to comment on what we built in in the trial in the prison male trial for the convenience basically? As frequent dosing?

Bahija Jallal: Do you want to comment on what we built in in the PRISM-mel trial for the convenience, basically?

Bahija Jallal: Do you want to comment on what we built in in the PRISM-mel trial for the convenience, basically? This frequent dosing?

Mohammed Dar: Yeah

Bahija Jallal: This frequent dosing?

Speaker #5: Right. So in the prison male trial, even though the phase one, two development with Brenny 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.

Mohammed Dar: Right. In the PRISM-mel trial, even though the phase I/II development with brenetafusp was weekly, given it's now combined with nivolumab, the way the trial is designed is after the first 3 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.

Speaker #5: So that's built into the pivotal trial from a patient convenience perspective.

Speaker #3: Thank you. Our next question today is coming from Romeo Connor from Kempen. Your line is now live.

Operator 2: Thank you. Our next question today is coming from Romy O'Connor from Kempen. Your line is now live.

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

Speaker #11: Hi. Thank you for taking my question and the presentation today. I have a question on the sales-related Rebeta cruels. So of the 120 million, I just wanted to ask if you could clarify what drives this size of payments.

Romy O'Connor: 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 payments. Going forward, how should we think about the normalization here in terms of cadence, maybe? Thank you.

Speaker #11: And going forward, how should we think about the normalization here in terms of cadence maybe? Thank you.

Speaker #2: Great.

Bahija Jallal: Great.

Speaker #1: Yeah. Thanks. I'm happy to take that question. So is two things have contributed to the rebate payments that we expect to make in the second half of this year.

Travis Coy: Yeah. Thanks. I'm happy to take that question. Two things have contributed to the rebate payments that we expect to make in the H2 of this year. One is our sales in Europe have been growing, 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 5 years in the H2 of this year. That's why we're seeing a higher number in the H2 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 to $70 million range.

Speaker #1: 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.

Speaker #1: 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 that 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 dollar range.

Speaker #3: Thank you. Our next question is coming from Jeff Jones from Oppenheimer. Your line is now live.

Operator 2: Thank you. Our next question is coming from Jeff Jones from Oppenheimer. Your line is now live.

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

Speaker #10: 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?

Jeff Jones: Thanks for taking the question, guys. Quick one regarding the AACR results and the 5-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?

Speaker #7: 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.

Ralph Torbay: Jeff, thank you for the question. I'm very excited about these 5-year results. Obviously, this is the first time that we talk about 5-year survival in this disease. Clearly, Kimmtrak is transformational for a lot of these patients. The 5-year results themselves will probably not have an impact, but it allowed us to see certain aspects of why we have a 14 months duration of therapy. For instance, 44% of patients alive at 5 years only saw Kimmtrak as their treatment. That speaks to 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.

Speaker #7: So clearly, Kimtrak is 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.

Speaker #7: So for instance, 44% of patients alive at five years only saw Kimtrak 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 Kimtrak.

Speaker #7: And this is something that we're 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 necessarily to drive the 14 months beyond what we've seen because it's been stable for the past three quarters.

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

Speaker #2: The 14 months are already much higher than what we've seen in clinical trials. Which tells you again how Kimtrak is really being successful in the market.

Bahija Jallal: 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.

Speaker #3: Thank you. Our next question is coming from Faisal Kersik from Jeffrey. Your line is now live.

Operator 2: Thank you. Our next question is coming from Faisal Khurshid from Jefferies. Your line is now live.

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

Speaker #12: Okay. Thanks so much for your question. This is Gabrielle dialing in for Faisal Kersheed. Can you speak about the extent to which you see Idea's oral regimen as a competitive risk to Kimtrak in uveal melanoma?

[Analyst] (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?

Speaker #12: 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?

Speaker #7: So thank you, Gabrielle, for the question. Look, I think this is good news for HLA-021-negative patients, who currently still have a very significant unmet need because they're not eligible for Kimtrak.

Ralph Torbay: 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.

Speaker #7: On the other side, for HLA021-positive patients, Kimtrak is the standard of care across all major markets. This is underpinned by five-year overall survival data that we just discussed.

Speaker #7: 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 Kimtrak, you're getting OS, you're getting safety that's tolerable for years.

Speaker #7: So I see Kimtrak being very much anchored in first line.

Speaker #3: Thank you. Our next question is coming from Roger Sharma from Goldman Sachs. Your line is now live.

Operator 2: Thank you. Our next question is coming from Rajan Sharma from Goldman Sachs. Your line is now live.

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

Speaker #13: 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 a varying cancer in the context of all the ADCs that we're seeing in development now, as well as the hematic data that we saw at ASCO.

Rajan Sharma: 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 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.

Speaker #13: What would you need to see to progress development in the setting? Thank you.

Mohammed Dar: 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, and our platform has a unique mechanism and there's no reason to expect why you couldn't combine the two. We've certainly shown in the clinic we can combine with chemotherapy. With regards to our 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 IMC-F106C-101 study, i.e., the maintenance trial. 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.

Speaker #5: 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 the ADCs are essentially targeted chemotherapy.

Speaker #5: And our platform has a unique mechanism, and 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.

Speaker #5: With regards to our 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 Brenny 101 study, i.e., the maintenance trial.

Speaker #5: 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 #3: Thank you. Our next question today is coming from Patrick Trujillo from HC Wainwright. Your line is now live.

Operator 2: Thank you. Our next question today is coming from Patrick Trucchio from HC Wainwright. Your line is now live.

Operator: Thank you. Our next question today is coming from Patrick Trucchio from HC Wainwright. Your line is now live.

Speaker #10: Hi. Good morning. This is Luis in for Patrick. Thanks for taking our questions. I was wondering for your NTAV platform and the HIV data.

[Analyst] (HC Wainwright): Hi, good morning. This is Luis in for Patrick. Thanks for taking our questions. Was wondering for your ImmTAV 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? What data should we expect there? Are you in any potential partnership discussions regarding that platform in general? Thank you so much.

Speaker #10: 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?

Speaker #10: 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 #2: It's a good assumption. I thank you so we try always to share data in a conference. So that's our goal. We always talk. Inside and outside.

Bahija Jallal: It's a good assumption. I think so. 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.

Speaker #2: On data, but there was another one, I think, in the question.

Mohammed Dar: What to expect for the data?

Speaker #5: What to expect for the data?

Speaker #2: Yeah. So 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.

Bahija Jallal: That's basically as we presented the multiple ascending dose last time, we definitely have not reached. We saw a start of 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 600 and 1.2 mg of data. That's what we will be sharing in the same fashion that we did for the first MAD data.

Speaker #2: And we didn't reach a DLT, if you will. So we were going up with the dose and now as we said, we will have data for 600 and 1.2 milligrams of data.

Speaker #2: So that's what we will be sharing, in the same fashion that we did for the first MAD data.

Speaker #3: Thank you. Our next question is from Jack Allen from Baird. Your line is now live.

Operator 2: Thank you. Our next question is from Jack Allen from Baird. Your line is now live.

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

Speaker #7: 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 Kimtrak in the first-line uveal melanoma setting.

Jack Allen: 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? Progression can occur on the drug, but ctDNA really seems to be the indicator of response and benefit.

Speaker #7: 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.

Speaker #7: 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.

Speaker #5: 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.

Mohammed Dar: 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 RECIST 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.

Speaker #5: And we published that for both for our pivotal phase three trial showing that it looked as a better circuit than even resist response for predicting long-term outcome.

Speaker #5: In our conversations with physicians, I think it varies. Institutions that are more academic and have access to either an in-house one, or they can utilize commercially available ctDNA, we definitely see that they will leverage this to help guide treatment decisions.

Speaker #5: 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 even using that as a guide to how to manage the patient.

Speaker #5: So we see it based on the expertise of individual investigators and institutions and access to ctDNA.

Speaker #2: Which I think we have to say, we have patients five years, six years, seven years, which was completely unheard of. So really happy with that.

Bahija Jallal: Which I think we have to say, we have patients five years, six years, seven years, which was completely unheard of, so really happy with that.

Speaker #3: 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.

Operator 2: 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 or closing comments.

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 or closing comments.

Speaker #2: All 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.

Bahija Jallal: 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.

Speaker #2: So thank you very much.

Speaker #3: Thank you. It does conclude today's teleconference and webcast. Let me disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Operator 2: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

Operator: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

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