Q2 2024 Immunocore Holdings PLC Earnings Call

August 8, 2024

Welcome to the Immunocore conference call and webcast. At this time all participants are in a listen-only mode.

Unknown Attendee: All participants are in a listen-only mode.

Operator: Participants are in a listen-only mode. The question and answer session will follow the formal presentation.

Unknown Attendee: A question and answer session will follow the formal presentation.

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

Unknown Attendee: If anyone wants to require operator assistance during the conference, please press star zero on your telephone keypad.

A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Unknown Attendee: As a reminder, this conference is being recorded.

Clayton Robertson: I would now like to turn the call over to Clayton Robertson, head of investor relations.

Operator: are in a list only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Clayton Robertson, head of investor relations. Thank you. You may begin.

As a reminder, this conference is being recorded. I would now like to turn the call over to Clayton Robertson, Head of Investor Relations. Thank you.

Clayton Robertson: Thank you. You may begin. Good morning and good afternoon. Thank you for joining us on our Q2 and first half, 2024 earnings call today. During today's call, we'll make some forward-looking statements, which are qualified by a 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 disclosed in our filings with the SEC.

Clayton Robertson: Good morning and good afternoon. Thank you for joining us on our Q2 and first half 2024 earnings call today. 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 four forward-looking statements, including those discussed in our filings with the SEC. On today's call, I'm joined by Bahija Jallal, CEO of Immunocore, and Brian DiDonato, CFO and Head of Strategy, who will share a strategy update.

Naureen Quibria: Hi, good morning, congratulations on all the progress. I guess my first question sort of follows up on the last one. It's in terms of, you know, the premium results that you'll be presenting at ESMO. You've observed benefits with ChemTrack outside of rhesus response, right? So can you remind us how you're tracking response rates under estimates? You know, should we just focus on the disease control rates? Or, you know, you mentioned that there'll be ctDNA. Is there anything else?

Clayton Robertson: Good morning and good afternoon. 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. On today's call, I'm joined by Bahija Jallal, CEO of Immunocore, and Brian DiDonato, CFO and Head of Strategy, who will share a strategy update. David Berman, Immunocore's Head of RD, will provide some pipeline updates, including near-term readouts in oncology and infectious diseases.

Clayton Robertson: Ralph Torbay, Head of Commercial, will review our first half KimTrak sales and additional growth opportunities for KimTrak. David Berman, Immunocore's head of RD, will provide some pipeline updates, including near-term readouts in oncology and infectious diseases. Brian will also provide highlights on our financial results reported this morning.

David Berman: Yeah, it's a good question. I mean, we certainly saw this with UVL melanoma. There are even patients with quote, radiographic increase in size that benefit from that survival benefit, but long-term survival. We saw a few patients with ranetophast in the cutaneous melanoma.

Clayton Robertson: Good morning and good afternoon. Thank you for joining us on our Q2 and first half 2024 earnings call today.

David Berman: We will, I think, continue to see that in the ovarian and the lung as well. I think the way that we're looking at how do you measure benefit, of course, is cpDNA, which is a way to measure independence of radiographic, but also looking at treatment beyond progression, because this is where the investigator sees the patient having a radiographic increase in size, but they feel the patient's benefiting. So we saw this early; this treatment beyond progression was a good initial indicator.

Speaker Change: 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 Change: Please note that actual results can vary materially from those indicated by these four looking statements, including those discussed in our filings with the SEC.

Clayton Robertson: On today's call, I'm joined by the heads of the law, CEO of Immunocore, and Brian D. Donato, CFO, and Head of Strategy, full-share a strategy update. Ralph Torbe, Head of Commercial, will review our first half-contract sales and additional growth opportunities for contract. David Bourbon, Immunocore's Head of R&D, will provide some pipeline updates, including near-term readouts in oncology and infectious diseases.

Speaker Change: On today's call, I'm joined by Bahija Jallal, CEO of Immunocore, and Brian DiDonato, CFO and Head of Strategy, who will share a strategy update. Ralph Torbay, Head of Commercial, will review our first half KimTrack sales and additional growth opportunities for KimTrack.

David Berman: David Berman, Immunocore's Head of R&D, will provide some pipeline updates, including near-term readouts in oncology and infectious diseases.

Brian Donato: Brian will also provide highlights on our financial results reported this morning.

Speaker Change: Brian will also provide highlights on our financial results reported this morning. Bahija?

Unknown Attendee: Thank you, Clay.

Bahija Jallal: Thank you, Clay. As you may be able to hear, I'm losing my voice, and I have pharyngitis. So to be able to answer your questions at the end, I will ask Brian to pitch it for me. Brian, please.

Bahija Jallal: Thank you, Clay. As you may be able to hear, I'm losing my voice and I have pharyngitis, so to be able to answer your questions at the end, I will ask Brian to pinch hit for me. Brian, please.

David Berman: Now, although we do see this TD benefit, we see it very strikingly for Chimtrac, we feel that with ranetophast, disease control rate is an equally good metric to predict PFS, and in fact, my sense of the data is that although ranetophast does have benefit in the TD, it is more of a disease, it has more disease control than Chimtrac did. But I think at the end of the day, of course, survival will be the ultimate endpoint. I do feel PFS is still a good endpoint for ranetophast.

Brian Donato: As you may be able to hear, I'm losing my voice, and I have Fahrenheit too. So, to be able to answer your questions at the end, I will ask Brian to pitch-hit for me.

Speaker Change: Thank you, Clay. As you may be able to hear, I'm losing my voice, and I have pharyngitis, so to be able to answer your questions at the end, I will ask Brian to pinch hit for me. Brian , please.

Brian Donato: Brian, please.

Brian DiDonato: Thank you, Bahija. We hope you feel

Unknown Attendee: Thank you. We hope you feel better.

Brian Donato: We are pleased to share with you an update on Immunocore through the first half of 2024. We have achieved excellent commercial results, while advancing our T-cell-engager platform in three therapeutic areas. We appreciate your continued support in advancing our mission of delivering innovative and life-changing medicines to patients.

Brian: Thank you, Bahija. We hope you feel better.

Brian DiDonato: We are pleased to share with you an update on Immunocore through the first half of 2024. We've achieved excellent commercial results while advancing our T-Cell Engager platform in three therapeutic areas. We appreciate your continued support in advancing our mission of delivering innovative and life-changing medicines to patients.

Mohammed Dar: Mohammed, anything to add to that?

Brian: We are pleased to share with you an update on Immunocore through the first half of 2024.

Naureen Quibria: Okay, that's helpful. And sort of sticking to the ovarian cancer topic, you know, what's the distribution of plane compared to folate receptor? Is there like an overlap there? I guess I'm just trying to gauge, you know, if you expect to see any patients coming off of state elahair, you know, into this, would there be any of those types of patients in the combo?

Brian: We've achieved excellent commercial results while advancing our T-Cell Engager platform in three therapeutic areas.

Unknown Executive: We appreciate your continued support in advancing our mission of delivering innovative and life-changing medicines to patients.

Brian: We appreciate your continued support in advancing our mission of delivering innovative and life-changing medicines to patients.

Brian Donato: Earlier this year, we outlined our three strategic pillars and our areas of focus for the next 18 to 24 months. Today, we will provide updates on the first two of these pillars. First, we continue to maximize KimTrack performance. Complete your report, continued sequential revenue growth for the quarter, and significant year-over-year growth for the first half of 2024. This growth is driven by strong U.S. performance. We expanded our customer base and increased market penetration, and reported longer duration of therapy. We also continue to increase our global footprint, with the additional country launches, allowing us to bring KimTrack to more patients around the world.

Unknown Executive: Earlier this year, we outlined our three strategic pillars and our areas of focus for the next 18 to 24 months.

Brian DiDonato: Earlier this year, we outlined our three strategic pillars and our areas of focus for the next 18 to 24 months.

Mohammed Dar: Sure, Naureen; happy to address that. So for PRAME, per se, it's very similar to ovarian cancer. It's around 80 to 90%. With the rest of the folate receptor alpha, for aloharic, it's like between 35 and 40%. The exact overlap, I don't think we have that data, but there's probably some overlap, but you can derive sort of 30 to 40% for the folate receptor, and 80 to 90% is the prevalence for PRAME in ovary.

David Berman: I'll just add that what we've continually seen, we saw in melanoma, BRAF mutant, and wild type in the, and with the EGFR, because we've looked at that mutation with that in the lung, we see brain expression independent of whether there's a mutation or not. And so, although, as Mohammed said, we don't have the exact overlap with folate receptor alpha, I suspect 90% of folate receptor alpha positives are going to be positive for brain, and I suspect 90% of folate receptor alpha negatives are going to be. I suspect that, but we just don't have that data right now.

Brian: Earlier this year, we outlined our three strategic pillars and our areas of focus for the next 18 to 24 months.

Brian: Today we will provide updates on the first two of these pillars.

Brian DiDonato: We will provide updates on the first two of these pillars. First, we continue to maximize ChemTrack performance. Please report continued sequential revenue growth for the quarter and significant year-over-year growth for the first half of 2024. Unknown Attendee by strong U.S.

Naureen Quibria: Thanks so much. Thanks for taking my question.

Unknown Executive: I am pleased to report continued sequential revenue growth for the quarter and significant year-over-year growth for the first half of 2024.

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

Brian: First, we continue to maximize ChemTrack performance.

Brian: I'm pleased to report continued sequential revenue growth for the quarter and significant year-over-year growth for the first half of 2024.

Rajan Sharma: Hi, thanks for taking my question. So I'm just coming back to KimTrack dynamics, and I just wanted to get your thoughts on how you see pricing evolving in the long term. So I think it was slide 10 where you laid out the increased patient opportunity with the additional indications, but just given the extent of that potential volume uplift, do you expect there to be some pressure on prices both in the US and in Europe?

Unknown Executive: We expanded our customer base and increased market penetration and reported longer duration of therapy. We also continue to increase our global footprint with additional country launches, allowing us to bring ChemTrack to more patients around the world.

Brian DiDonato: We expanded our customer base and increased market penetration and reported longer duration of therapy. We will also continue to increase our global footprint with additional country launches, allowing us to bring Chemtrack to more patients around the world.

Brian: This quote is driven by strong U.S. performance.

Brian: We've expanded our customer base and increased market penetration and reported longer duration of therapy.

Brian: We also continue to increase our global footprint with additional country launches, allowing us to bring ChemTrack to more patients around the world.

Brian Donato: To achieve our longer-term growth objectives for KimTrack, we are simultaneously pursuing label expansion, and both late-lying cutaneous melanoma, with the ongoing TAB-EM trial, and also an adjuvant UVO melanoma, with the soon-to-start Atom trial. It's successful. These two expansions may allow up to 6,000 patients to benefit from the survival benefit of KimTrack.

Brian DiDonato: To achieve our longer-term growth objectives for QIBTRAC, we are simultaneously pursuing label expansion in both late-line cutaneous melanoma with the ongoing TEBI-AM trial and also in adjuvant uveal melanoma with the soon-to-start ADAM trial. These two expansions may allow up to 6,000 patients to benefit from the survival benefit of Kim

Unknown Executive: To achieve our longer-term growth objectives for QIBTRAC, we are simultaneously pursuing label expansion in both late-line cutaneous melanoma with the ongoing TEBI-AM trial and also in adjuvant uveal melanoma with the soon-to-start ADAM trial, if successful. These two expansions may allow up to 6,000 patients to benefit from the survival benefit of kidney transplantation.

Brian: To achieve our longer-term growth objectives for QIBTRAC, we are simultaneously pursuing label expansion in both late-line cutaneous melanoma with the ongoing TEBI-AM trial and also in adjuvant uveal melanoma with the soon-to-start ADAM trial.

Brian: If successful, these two expansions may allow up to 6,000 patients to benefit from the survival benefit of Chibtrek.

Brian Donato: Moving to the second strategic pillar, our aim is to progress our nine clinical programs. All first-in-class, leading by specific TCR therapies. Innovative research engine to identify additional novel targets and therapeutics. At ASCO, we presented phase one data of Preventifus, our premium targeted therapy. Impregnously treating cutaneous melanoma patients, which drove the decision to start the phase three registration trial in first line cutaneous melanoma patients. Next one that has no, we will present late line ovarian cancer data, and in Q4 we are planning to present late line data in lung cancer at a medical conference. We are also excited about the potential of our platform to treat infectious diseases.

Brian DiDonato: Moving to the second strategic pillar, our aim is to progress our nine clinical programs, all first-in-class, leading by specific TCR therapy. Innovative Research Engine to identify additional novel targets and therapeutics.

Brian: Moving to the second strategic pillar, our aim is to progress our nine clinical programs, all first-in-class, leading by specific TCR therapies.

Unknown Executive: Innovative Research Engine to Identify Additional Novel Targets in Therapeutics

Brian: Innovative Research Engine to Identify Additional Novel Targets in Therapeutics.

David Berman: At ASCO, we presented Phase 1 data of brenetaphos, or pre-targeted therapy.

David Berman: At ASCO, we presented Phase 1 data of brenetaphos, our PRAME-targeted therapy, previously treating cutaneous melanoma patients, which drove the decision to start the phase three registrational trial in first-line cutaneous melanoma patients.

Brian: At ASCO, we presented Phase 1 data of brenetaphos, or brain-targeted therapy.

David Berman: and previously treated cutaneous melanoma patients, which drove the decision to start the Phase III Registrational Trial in first-line cutaneous melanoma patients.

Brian: and previously treated cutaneous melanoma patients, which drove the decision to start the Phase III Registrational Trial in first-line cutaneous melanoma patients.

David Berman: Next month at ESMO, we will present late-line ovarian cancer data, and in Q4, we are planning to present late-line data on lung cancer at a medical conference.

Brian: Next month at ESMO we will present late line ovarian cancer data and in Q4 we're planning to present late line data in lung cancer at a medical conference.

Unknown Executive: We're also excited about the potential of our platform to treat infectious diseases. As you recall, our

David Berman: We're also excited about the potential of our platform to treat infectious diseases. As you recall, our objective is to deliver a functional cure for people living with HIV, and we expect to present the MADD data from our HIV trial early next year, and I'll ask the team to share additional details. First, Ralph will discuss ChemTrac's commercial performance.

Brian: We're also excited about the potential of our platform to treat infectious diseases.

Brian Donato: As you recall, our objective is to deliver a functional cure for people living with HIV, and we expect to present the mad data from our HIV trial early next year.

Brian: As you recall, our objective is to deliver a functional cure for people living with HIV, and we expect to present the MADD data from our HIV trial early next year.

Brian Donato: I will now ask in the shared additional details. First, Ralph will discuss Chemtrax commercial performance.

Ralph Torbay: I'll ask the team to share additional details, but first, Ralph will discuss Chemtrack's commercial performance. Ralph

Rajan Sharma: And I guess related to your comments on Europe, if there is kind of downward pressure on price for these additional indications, do you think that a European launch would be viable for those? And then just to follow up, and sorry if I missed it, but in ovarian cancer, do you expect to include folate receptor alpha positive patients in that trial as well? And then just one follow-up on HIV, if I could, where do you think the dose could go? So I think at the minute you said 300 is the upper level. Related to that, how high do you think you can dose? Thank you.

Brian: I'll now ask the team to share additional details. First, Ralph will discuss ChemTrac's commercial performance. Ralph?

Ralph Torbay: Thank you, Brian, and hello everyone. We've had a strong first half in 2024, delivering $146 million in net sales, which represents a 34% increase compared to the same period last year. I'm proud of our cross-functional teams' achievements and commitment as we expanded our reach to more patients. We've now launched Chemtrax in 19 countries, including nine new launches since the beginning of the year. In the context of a challenging reimbursement environment in Europe, we have made good progress with access, signing two additional reimbursement agreements in Poland and Sweden, which are expected to launch in the fourth quarter.

Ralph Torbay: Thank you, Brian, and hello, everyone. We've had a strong first half of 2024, delivering $146 million in net sales, which represents a 34% increase compared to the same period last year. I am proud of our cross-functional team's achievements and commitment as we expanded our reach to more patients. We've now launched ChemTrack in 19 countries, including 9 new launches since the beginning of the year.

Rajan Sharma: Great. Thank you, Rajan. I have several questions. Maybe we'll start with HIV, and then we'll go from there to common

Ralph Torbay: Thank you, Brian, and hello, everyone. I am proud of our cross-functional team's achievements and commitment as we expanded our reach to more patients. In the context of a challenging reimbursement environment in Europe, we have made good progress with access. In Q2, we also announced the acceleration of our Phase 3 trial of the TEBI-AM study in advanced cutaneous melanoma. This is an important part of our growth strategy beyond MUM, and we are very pleased with this program.

Ralph: Thank you, Brian , and hello, everyone.

Ralph: We've had a strong first half in 2024, delivering $146 million in net sales which represents a 34% increase compared to the same period last year.

Speaker Change: I'm proud of our cross-functional team's achievements and commitment as we expanded our reach to more patients.

Speaker Change: We've now launched ChemTrack in 19 countries, including 9 new launches since the beginning of the year.

Ralph Torbay: In the context of a challenging reimbursement environment in Europe, we have made good progress with access, signing two additional reimbursement agreements in Poland and Sweden, which are expected to launch in the fourth quarter. In Q2, we also announced the acceleration of our Phase 3 trial of the TEBI-AM study in advanced cutaneous melanoma. This is an important part of our growth strategy beyond MUM, and we are very pleased with this progress. I will now take you through the figures and financial performance in more detail.

Brian: In the context of a challenging reimbursement environment in Europe , we have made good progress with AXIS, signing two additional reimbursement agreements in Poland and Sweden, which are expected to launch in the fourth quarter.

Ralph Torbay: In Q2, we also announced the acceleration over our Phase 3/12, the Tabby AM study in the advanced cutaneous melanoma. This is an important part of our growth strategy beyond MUM, and we are very pleased with this progress.

Brian: In Q2, we also announced the acceleration of our Phase 3 trial of the TEBI-AM study in advanced cutaneous melanoma.

Speaker Change: This is an important part of our growth strategy beyond MUM and we are very pleased with this progress.

Ralph Torbay: I will now take you through the figures and financial performance in more detail. We delivered $75.3 million in net revenues with Chemtrax in the second quarter, which is an increase of 7% compared to the first quarter. Net revenue growth was driven primarily by the US, where we saw an 11% growth compared to the first quarter. This growth comes from our continued focus on the community and increasing duration of therapy. We estimate we now have around 65% market share in the US and believe there continues to be opportunity for further growth. In terms of penetration since launch, over 500 unique sites in the US have treated patients with Chemtrax, most in the community.

Ralph Torbay: I will now take you through the figures and financial performance in more detail. We delivered $75.3 million in net revenues with Chemtrack in the second quarter, which is an increase of 7% compared to the first quarter. Net revenue growth was driven primarily by the US, where we saw an 11% growth compared to the first quarter.

Speaker Change: I will now take you through the figures and financial performance in more detail.

Ralph Torbay: We delivered $75.3 million in net revenues with Chemtrack in the second quarter, which is an increase of 7% compared to the first quarter. Net revenue growth was driven primarily by the U.S., where we saw 11% growth compared to the first quarter.

Speaker Change: We delivered $75.3 million in net revenues with Chemtrack in the second quarter, which is an increase of 7% compared to the first quarter.

Speaker Change: Net revenue growth was driven primarily by the US, where we saw an 11% growth compared to the first quarter.

Ralph Torbay: This growth comes from our continued focus on the community and increasing duration of therapy. We estimate we now have around 65% market share in the US and believe there continues to be opportunity for further growth. In terms of penetration since launch, over 500 unique sites in the U.S. have treated patients with chemtrails, most in the community.

Brian: This growth comes from our continued focus on the community and increasing duration of therapy.

Speaker Change: We estimate we now have around 65% market share in the U.S. and believe there continues to be opportunity for further growth.

Speaker Change: In terms of penetration since launch, over 500 unique sites in the U.S. have treated patients with ChemTrac.

Ralph Torbay: To continue expanding our reach, we are constantly innovating and recently rolled out our AI-enabled patient-finding tool. This has allowed us to find more patients in lower density community centers while keeping our field-force footprint unchanged. Our goal is to continue growing the US through further market penetration and appropriately supporting duration of therapy, currently trending to 11 plus months. This is exceptional and speaks with different mechanism of action with the benefit of Chemtrax extending beyond the typical resist response. Many patients with the best response of table disease do well and remain on chemtrax years later, contributing to the growing duration of therapy we observe.

Ralph Torbay: To continue expanding our reach, we're constantly innovating and recently rolled out our AI-enabled patient-finding tool. This has allowed us to find more patients in lower-density community centers while keeping our field force footprint unchanged. Our goal is to continue growing the U.S. through further market penetration and appropriately supporting duration of therapy, currently trending to 11+. This is exceptional and speaks to a different mechanism of action, with the benefit of Chemtruck extending beyond the typical resist response.

Speaker Change: Most in the community.

Speaker Change: To continue expanding our reach, we're constantly innovating and recently rolled out our AI-enabled patient finding tool. This has allowed us to find more patients in lower density community centers while keeping our field force footprint unchanged.

Speaker Change: Our goal is to continue growing the U.S. through further market penetration and appropriately supporting duration of therapy, currently trending to 11-plus months.

Speaker Change: This is exceptional and speaks to a different mechanism of action with the benefit of chemtruck extending beyond the typical resist response.

Ralph Torbay: Many patients with the best response to stable disease do well and remain on Chemtrail years later, contributing to the growing duration of therapy we observe. Shifting gears to Europe, demand flattened in Q2, and revenues declined net of a $6.7 million increase in rebate reserves.

David Berman: Many patients with the best response to stable disease do well and remain on Chemtrail years later, contributing to the growing duration of therapy we observe. However, the access environment remains very challenging across Europe, and we expect incremental demand growth in the second half of the year to come from launches in Poland and Sweden. I'm pleased with our team's effort to reach more patients globally with MUM, driving near-term growth. This is exciting and helps us in two ways.

Speaker Change: Many patients with the best response of stable disease do well and remain on Chemtrail years later, contributing to the growing duration of therapy we observe.

Ralph Torbay: Schifting gears to Europe, demand flattened in Q2, and revenues declined net of 6.7 million increase in rebate reserves. The access environment remains very challenging across Europe, and we expect incremental demand growth in the second half of the year to come from the launches in Poland and Sweden. I'm pleased with our team's effort to reach more patients globally with MUM, driving near-term growth. KimTrack has the potential to benefit patients beyond MUM and drive mid-term growth through label expansion with the TBAM study. Following a consultation with the FDA, we converted and accelerated our TBAM study into a Phase three registrational trial in second line plus advanced cutaneous melanoma.

Speaker Change: Shifting gears to Europe , demand flattened in Q2, and revenues declined net of $6.7 million increase in rebate reserves.

Ralph Torbay: The access environment remains very challenging across Europe, and we expect incremental demand growth in the second half of the year to come from the launches in Poland and Sweden. I'm pleased with our team's effort to reach more patients globally with MUM, driving near-term growth. ChemTrac has the potential to benefit patients beyond MUM and drive midterm growth through label expansion with the TebAAM study. Following a consultation with the FDA, we converted and accelerated our Teb-EAM study into a Phase III Registrational Trial in 2nd Line Plus Advanced Cutaneous Melanoma.

Speaker Change: The access environment remains very challenging across Europe , and we expect incremental demand growth in the second half of the year to come from the launches in Poland and Sweden.

Speaker Change: I'm pleased with our team's effort to reach more patients globally with MUM, driving near-term growth.

Speaker Change: Kimtrack has the potential to benefit patients beyond MUM and drive midterm growth through label expansion with the TebAAM study.

Speaker Change: Following a consultation with the FDA, we converted and accelerated our TEB-EAM study into a Phase III Registrational Trial in Second Line Plus Advanced Cutaneous Melanoma.

Ralph Torbay: This is exciting and helps us in two ways. First, to robustly test the PD-1 combination and KimTrack monotherapy arms. And second, by rolling the 120 patients already enrolled into the phase two, we accelerate the time to final analysis of the phase three by up to 12 months. We now expect to complete the enrollment in the first half of 2026 and potentially see data in the second half, noting, of course, the event-driven nature of the endpoint.

Ralph Torbay: This is exciting and helps us in two ways. First, to robustly test the PD-1 combination and ChemTrac monotherapy arms. And second, by rolling the 120 patients already enrolled into the Phase II, we accelerate the time to final analysis of the Phase III by up to 12 months. We now expect to complete enrollment in the first half of 2026 and potentially see data in the second half. Noting, of course, the event-driven nature of the... Today, we're only at the beginning of the Chemtrail journey.

David Berman: First, to robustly test the PD-1 combination and ChemTrac monotherapy arms. And second, by rolling the 120 patients already enrolled into the Phase II study, we accelerate the time to final analysis of the Phase III by up to 12 months. Our two ongoing Phase III Registrational Clinical Trials position us for continued growth in the mid to long term. With the TEBI-AM trial, we see the potential to extend the benefit of Chemtruck to up to 4,000 additional patients with 2nd line plus metastatic cutaneous melanoma.

Speaker Change: This is exciting and helps us in two ways. First, to robustly test the PD-1 combination and ChemTrac monotherapy arms. And second, by rolling the 120 patients already enrolled into the Phase 2, we accelerate the time to final analysis of the Phase 3 by up to 12 months.

Speaker Change: We now expect to complete the enrollment in the first half of 2026 and potentially see data in the second half.

Speaker Change: Noting, of course, the event-driven nature of the endpoint.

Ralph Torbay: Today, we're only at the beginning of the KimTrack journey. In MUM, we're growing KimTrack double-digit year-over-year as we increase our penetration in the U.S. support duration of therapy around the world and launch new markets. Our two ongoing phase three registrational clinical trials positioned us for a continued growth in the mid-to-long term. With the TBAM trial, we see the potential to extend the benefit of KimTrack to up to four thousand additional patients with second-line plus metastatic mutinous melanoma. With the atom trial, we see this benefit expanded into the adjuvant UVO melanoma setting where all the evidence with KimTrack points to our platform being potentially transformative.

David Berman: Unknown Attendee Yeah, so with the HIV, I mean, if you remember, we showed that at 15 micrograms, we're already seeing target engagement because we saw IL-6. With our platform, you don't need to give a lot. With Chemtrail, at the 64 and 68 microgram doses, we see a survival benefit. So we don't know how high we can go; we're going to go as high as needed.

Ralph Torbay: But we certainly know that, you know, you don't need to go up to milligram doses with our platform. In terms of the folate receptor alpha, we don't exclude prior folate receptor alpha therapy. In fact, we have had a few patients who were who had prior ADC enroll in our trial. Our approach, once again, is not to replace the MRVA. It's not to go head to head, which is why it's added on to chemotherapy. And so it's independent of the MRVA data.

Ralph Torbay: In MUM, we're growing Chemtrail double-digit year over year as we increase our penetration in the U.S., support duration of therapy around the world, and launch new markets. Our two ongoing Phase III Registrational Clinical Trials position us for continued growth in the mid to long term. With the TEBI-AM trial, we see the potential to extend the benefit of ChemTrac to up to 4,000 additional patients with 2nd line plus metastatic cutaneous myeloma. With the ATOM trial, we see this benefit expanded into the adjuvant setting of uveal melanoma, where all the evidence with KimTrack points to our platform being potentially transformative. If successful, we could help up to 6,000 patients across all three indications live longer and better lives. I'm very excited about our future, and to tell you more, I'll hand over to David.

Ralph Torbay: And Ralph, can you comment on the reimbursement? Just to reiterate here, I don't think we have any issues in the U.S., but it's mostly the EU. Go ahead, Ralph, please. Sure, happy to.

Speaker Change: Today we're only at the beginning of the Chemtrail journey. In MUM, we're growing Chemtrail double digit year over year as we increase our penetration in the US, support duration of therapy around the world, and launch new markets.

Speaker Change: Our two ongoing Phase III Registrational Clinical Trials position us for continued growth in the mid-to-long term.

Speaker Change: With the TEBI-AM trial, we see the potential to extend the benefit of ChemTrac to up to 4,000 additional patients with second-line plus metastatic cutaneous melanoma.

David Berman: With the ATOM trial, we see this benefit expanded into the adjuvant juvenile melanoma setting, where all the evidence with ChemTrac points to our platform being potentially transformative. If successful, we could help up to 6,000 patients across all three indications live longer and better lives. I'm very excited about our future, and to tell you more, I'll hand over to David.

Speaker Change: With the ATOM trial, we see this benefit expanded into the adjuvant and juvenile melanoma setting where all the evidence with ChemTrac points to our platform being potentially transformative.

Ralph Torbay: If successful, we could help up to 6,000 patients across all three indications with longer and better lives.

Speaker Change: If successful, we could help up to 6,000 patients across all three indications live longer and better lives.

David Bourbon: I'm very excited about our future, and to tell you more, I'll hand over to David.

Ralph Torbay: Sure, happy to. So, first of all, our pricing strategy really depends on the benefit that we see from the data, right? So, if it brings significant benefits to patients and society, that's how we price our further indications. To your question on the U.S. and to Bahija's point, we have not seen any downward pressure on the U.S. so far. In fact, I expect that if the data is good and cutaneous, given that these are settings of high unmet need and with small patient populations, that we would not have to erode the price significantly in the U.S. On the other hand, in Europe, you have a good question in terms of price erosion, and I think it's too soon to tell.

Speaker Change: I'm very excited about our future, and to tell you more, I'll hand over to David.

David Bourbon: Thank you, Ralph. I'm really pleased to update you on the strong progress we've made on our pipeline. I'm proud of our R&D team. We have hit all our development milestones in progressing nine clinical programs, including three Phase Three trials, starting three new Phase Ones, and expanding to three therapeutic areas. Today, I'm going to focus on the two clinical stage programs with data readouts over the next 18 months: Bernadophess and HIV.

David Berman: I'm really pleased to update you on the strong progress we've made on our pipeline. I'm proud of our R&D team.

Ralph Torbay: We need data for us to decide whether we'll be launching in Europe or not, although it is a very tough market access environment, frankly, one of the toughest I've seen through all my years of working with Europe.

David Berman: I'm really pleased to update you on the strong progress we've made on our pipeline. I'm proud of our R&D team.

David Berman: Thank you, Ralph.

David Berman: I'm really pleased to update you on the strong progress we have made on our pipeline.

Ethan Markowski: Thank you. Our next questions come from the line of Ethan Markowski with Needham and Company. Please proceed with your question.

David Berman: We have hit all our development milestones in progressing nine clinical programs, including three phase three trials, starting three new phase ones, and expanding to three therapeutic areas. Today, I'm going to focus on two clinical stage programs with beta readouts over the next 18 months, BRNF and HIV. Let's recall our strategy in cutaneous melanoma and the data supporting the Phase III trial. Once patients progress on these available therapies, the only options are clinical trials and TILs for select patients. Third, we see higher activity in pre-positive versus pre-negative. This provides biological plausibility as the pre-negative subset behaves as an internal negative control.

David Berman: I'm proud of our R&D team. We have hit all our development milestones in progressing nine clinical programs, including three phase three trials, starting three new phase ones, and expanding to three therapeutic areas.

Ethan Markowski: Hi, this is Ethan on behalf of Gil. Thank you for taking our questions. I think most of them have been answered thus far, but I'm just wondering, so I know endometrial is not one of the focus indications for PREIM, but I'm wondering if you plan on going into a similar strategy there where moving maybe combinations in earlier lines, like you're planning to do non-small cell lung cancer and ovarian. And then for Kim Track, you talked about the difficult reimbursement in Europe. Will growth there really be mostly driven by just adding additional countries, or do you think that those dynamics are likely to change over time?

David Berman: Today I'm going to focus on the two clinical stage programs with data readouts over the next 18 months, brunetta, FUSP, and HIV.

David Bourbon: Let's recall our strategy in containers Malnoma and the data supporting the phase three trial. The most common therapies used globally are anti-PD1, either as monotherapy or in combination, and B-raft therapy for B-raft mutation positive patients. Once patients progress on these available therapies, the only options are clinical trials and pills for select patients. Our strategy is to demonstrate in the phase one trial in third-line patients that Bernadophess is active and well-calibrated, and that this activity would support a TFS endpoint in a phase three trial in first line. Here's a summary of the key data from the phase one trial we presented at ASCO.

Ethan Markowski: Thank you.

David Berman: Let's recall our strategy in cutaneous melanoma and the data supporting the phase 3 trial.

David Berman: The most common treatments used globally are anti-PD-1, either as monotherapy or in checkpoint combination, and BRAF therapy for BRAF mutation-positive patients. Once patients progress on these available treatments, the only options are clinical trials and TILs for select patients. Our strategy is to demonstrate in the phase one trial in third-line patients that Bonetifus is active and well-tolerated, and that this activity would support a PFS endpoint in a phase three trial in first-line. Here's a summary of the key data from the phase 1 trial we presented at ASCA. First,

Mohammed Dar: Thank you, Ethan. Mohammed, you can take the first one, and Ralph, maybe, in Europe. Thanks, Ethan for the

David Berman: The most common therapies used globally are anti-PD-1 either as monotherapy or in checkpoint combination and BRAF therapy for BRAF mutation positive patients.

Mohammed Dar: Thanks, Ethan, for the question. I think, you know, as David mentioned, the focus has been on ovarian, you know, melanoma, and lung cancer for now. So the endometrial data that we're generating is really in monotherapy with some of the chemotherapies that are used in late-line. And, you know, right now, we don't have current plans to explore endometrial and ergo lines until we actually generate data in late-lines to guide us.

Mohammed Dar: Thank you. Sure. Um, so.

David Berman: Once patients progress on these available therapies, the only options are clinical trials and pills for select patients.

Speaker Change: Our strategy is to demonstrate in the Phase I trial in third-line patients that Bonetefest is active and well-tolerated, and that this activity would support a TFS endpoint in a Phase III trial in first-line.

David Berman: so

David Bourbon: First, Brenny has monotherapy activity, something not commonly seen for other biologics in heavily pretreated melanoma. Second, the disease control rate, which is a surrogate of progression through survival, is higher for Burnettifus monotherapy than the combination of Nevolumat plus Lyratlamin in a similar setting. Third, we see higher activity in brain positive versus brain negative. This provides biological plausibility as the brain negative subset behaves as an internal negative control. And finally, the systemic T cell fitness data indicates we expect an even higher disease control rate and longer PFS in first line. These data supported our decision to move to phase three in first line.

Ralph Torbay: Sure. So there is, in fact, a very tough environment in Europe, as we've been discussing. However, we've had a lot of successes when it comes to reimbursement. So we've had nine launches in the first half of the year, and we expect some of that marginal growth will come from further additional launches because we're currently in negotiations with several companies. In addition to that, I mean, obviously, we're very well penetrated, and the team has been doing a great job in Europe, so really, it's the launch that's driving the next level of growth.

David Berman: Here's a summary of the key data from the Phase 1 trial we presented at AFSCO first.

David Berman: Brenny has monotherapy activity, something not commonly seen for other biologics in heavily pre-treated melanoma. Second, the disease control rate, which is a surrogate of progression-free survival, is higher for brenetophos monotherapy than the combination of nivolumab plus relaplamib in a similar setting. Third, we see higher activity in PRAME positive versus PRAME negative. This provides biological plausibility as the PRAME negative subset behaves as an internal negative control.

Speaker Change: Brenny has monotherapy activity, something not commonly seen for other biologics in heavily pretreated melanoma.

Speaker Change: Second, the disease control rate, which is a surrogate of progression-free survival, is higher for bronetophos monotherapy than the combination of nivolumab plus relaplamib in a similar setting.

David Berman: Third, we see higher activity in pre-positive versus pre-negative. This provides biological plausibility as the pre-negative subset behaves as an internal negative control.

David Berman: And finally, the systemic T cell fitness data indicates we expect an even higher disease control rate and longer PFS in first line. These data supported our decision to move to Phase 3 in Firstline. In our Phase III first-line trial, we will combine two biologics, renetifest and nivolumab, each with monotherapy activity and complementary mechanisms of action. Based on the phase 1 cross-trial comparison I just shared with you, we fully expect that Brinetta Plus plus Novolumab in the first line setting will be superior to both Novolumab alone and Novolumab plus relatively.

David Berman: And finally, the systemic T cell fitness data indicates we expect an even higher disease control rate and longer PFS in first line. These data supported our decision to move to Phase 3 in Firstline. In our Phase 3 first-line trial, we will combine two biologics, renetifest and nivolumab. We are pleased to announce that the Phase 3 PRISM-L301 study has started, and we are focused on activating more sites globally. With the PRISM-L301 in the first line I just shared, and with the TEBI-AM in the second line that Ralph shared, we are really proud to be one of the few companies to have multiple phase three investments in cutaneous melanoma, both backed by strong data. I will now turn to Brunetta Fuspin-O'Varian.

David Bourbon: In our phase three first line trial, we will combine two biologics, Burnettifus and the Volume App, each with monotherapy activity and with complementary mechanisms of action. Based on the phase one cross-trial comparison I just shared with you, we fully expect that Burnettifus plus the volume app in the first line setting will be superior to both the volume app alone and the volume app plus Relatlamin. We are pleased to announce that the phase three prism mel 3.01 study has started and we are focused on activating more sites globally.

David Berman: In our phase 3 first-line trial, we will combine two biologics, sprenetifesp and nivolumab, each with monotherapy activity and with complementary mechanisms of action.

Speaker Change: Based on the phase 1 cross trial comparison I just shared with you, we fully expect that Brinetta Plus plus Novolumab in the first line setting will be superior to both Novolumab alone and Novolumab plus Relatlimer.

David Berman: We are pleased to announce that the Phase 3 PRISM-L301 study has started, and we are focused on activating more sites globally. With the PRISM-L301 in the first line I just shared, and with the TEBI-AM in the second line that Ralph shared, we are really proud to be one of the few companies to have multiple phase three investments in cutaneous melanoma, both backed by strong data. I will now turn to

David Berman: We are pleased to announce that the Phase 3 PRISM-L301 study has started, and we are focused on activating more sites globally.

David Bourbon: With the prism mel 3.01 in first line, I just shared and with the tippy am in second line that RELF shared, we are really proud to be one of the few companies to have multiple phase three investments in botanias melanoma, both backed by strong data.

Speaker Change: With the PRISM-L301 in first line I just shared, and with the TEVI-AM in second line that Ralph shared,

Speaker Change: We are really proud to be one of the few companies to have multiple Phase III investments in cutaneous melanoma, both backed by strong data.

David Bourbon: I will now turn to Burnettifus in ovarian cancer. Women with ovarian carcinoma are cycled through platinum regiments shown in the blue until they become resistant or refractory, shown in the green, at which point they receive non-platinum chemotherapies or the folate alpha receptor positive tumors and a body drug conjugate. Unlike melanoma, ovarian cancer has historically not been sensitive to immunotherapy. In heavily pre-created platinum resistance, which is the population in our phase one trial, the outlook is poor, with non-platinum chemotherapies having response rates less than 10%, and disease control rates between 40 to 50%. In our phase one trial, we aim to demonstrate in the platinum resistance setting that brinettifus is clinically active and can be combined with non-platinum chemo.

Ralph: I will now turn to Brenetta Fuspin, Ovarian Cancer.

David Berman: Women with ovarian carcinoma are cycled through platinum regimens, shown in the blue, until they become resistant or refractory, shown in the green, at which point they receive non-platinum chemotherapies or, for the folate alpha, Receptor Positive Tumors Antibody Drug Conjugate. Unlike melanoma, ovarian cancer has historically not been sensitive to immunotherapy. In heavily pretreated platinum resistance, which is the population in our phase one trial, the outlook is poor, with non-platinum chemotherapies having response rates less than 10% and disease control rates between 40 to 50 percent. In our phase one trial, we aim to demonstrate in the platinum-resistant setting that brnetifusk is clinically active and can be combined with non-platinum chemotherapeutics. This will be the subject of our ESMO poster next month.

Speaker Change: Women with ovarian carcinoma are cycled through platinum regiments, shown in the blue, until they become resistant or refractory, shown in the green, at which point they receive non-platinum chemotherapies, or, for the folate alpha

Speaker Change: Receptor Positive Tumors Antibody Drug Conjugate

Speaker Change: Unlike melanoma, ovarian cancer has historically not been sensitive to immunotherapy.

Unknown Attendee: All participants are in a list and only mode.

Unknown Attendee: A question and answer session will follow the formal presentation. Then once you require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

David Berman: In heavily pretreated platinum resistance, which is the population in our phase one trial, the outlook is poor, with non-platinum chemotherapies having response rates less than 10% and disease control rates between 40 to 50 percent. This will be the subject of our Esmo poster next month. We have learned from our platform that clinical benefit manifests as disease control, that activity is even higher in earlier life, and that combinability with standards of care may enable at least additive activity.

Speaker Change: In heavily pretreated platinum resistance, which is the population in our phase 1 trial, the outlook is poor, with non-platinum chemotherapies having response rates less than 10% and disease control rates between 40 to 50%.

Clayton Robertson: I would now like to turn the call over Clayton Robertson, head of investor relations. Thank you. You may begin.

Clayton Robertson: Good morning and good afternoon. Thank you for joining us on our Q2 and first half, 2024 earnings call today. During today's call, we'll make some forward-looking statements, which are qualified by our state proper provision under the private security's 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.

Speaker Change: In our Phase 1 trial, we aim to demonstrate, in the platinum-resistant setting, that brinetifusk is clinically active and can be combined with non-platinum chemo. This will be the subject of our ESMO poster next month.

David Bourbon: This will be the subject of Ovarianoposter next month. We have learned for our platform that clinical benefit manifests as disease control; that activity is even higher in early lines, and that combined ability with standards of care may enable at least additive activity. In addition, unlike melanoma, ovarian cancer is more complex, with two distinct disease segments that are treated very differently, which requires us to study more combination.

David Berman: We have learned from our platform that clinical benefit manifests as disease control, that activity is even higher in earlier lines, and that combinability with standards of care may enable at least additive activity. In addition, unlike melanoma, ovarian cancer is more complex, with two distinct disease segments that are treated very differently, which requires us to study more combinations.

Speaker Change: We have learned from our platform that clinical benefit manifests as disease control, that activity is even higher in earlier lines, and that combinability with standards of care may enable at least additive activity.

Clayton Robertson: On today's call, I'm joined by the Heads of the Law, CEO of Immunocore, and Brian D. Donato, CFO and Head of Strategy, full-share a strategy update. Ralph Torbay, Head of Commercial, will review our first half-contract sales and additional growth opportunities for contract.

David Berman: In addition, unlike melanoma, ovarian cancer is more complex, with two distinct disease segments that are treated very differently, which requires us to study more combinations. Therefore, our next step in ovarian cancer is twofold. First, and Vernetta Fusk is a first-in-class claim impact.

Speaker Change: In addition, unlike melanoma, ovarian cancer is more complex, with two distinct disease segments that are treated very differently, which requires us to study more combinations.

David Bourbon: Therefore, our next step in ovarian is twofold. First, in the heavily pretreated platinum-resistant disease, we will expand our patient data set of combinations with non-platinum chemotherapy. And second, in the earlier line, platinum-sensitive disease setting, we will test the combinations with devisism app and with platinum chemotherapy.

David Berman: Therefore, our next step in ovarian cancer is twofold. First, in heavily pre-treated platinum-resistant disease, we will expand our patient data set of combinations with non-platinum chemotherapy, and second. In the earlier line, platinum-sensitive disease setting, we will test the combinations with bevacizumab and platinum chemotherapy. Now, let's turn to lung cancer. Late-line lung cancer is a heterogeneous disease, with patients generally having rapid progression.

Clayton Robertson: David Burman, Immunocore's Head of R.D, will provide some pipeline updates, including near-term readouts in oncology and infectious diseases. Brian will also provide highlights on our financial results report this morning. Thank you, Clay.

Speaker Change: Therefore, our next step in ovarian is two-fold. First,

Speaker Change: In the heavily pre-treated platinum-resistant disease, we will expand our patient data set of combinations with non-platinum chemotherapy. And second,

Speaker Change: In the earlier line, platinum sensitive disease setting, we will test the combinations with bevacizumab and with platinum chemotherapy.

Brian Donato: As you may be able to hear, I'm losing my voice, and I have Fahrenheit to show. To be able to answer your questions at the end, I will ask Brian to pitch-hit for me.

David Bourbon: Let's now turn to line cancer. Clayline line cancer is a heterogeneous disease with patients generally having rapid progression. With line, we're still in the signal detection phase. Later this year, we plan to share monotherapy in heavily pre-created line cancer selected for premium expression and combinations with the late line chemotherapies enrolled without regard to selection for premium expression. The next steps are additional combinations with a c-murtenant in the Egypthar mutants, patients, and with those attacks. This will then be followed by first line platinum combinations. Premium is a promising target across multiple tumors, and Bernetifus is a first-in-class premium tech.

Speaker Change: Let's now turn to Lyme cancer.

Brian Donato: Brian, please. We hope you feel better. We are pleased to share with you an update on Immunocore through the first half of 2024. We have achieved excellent commercial results while advancing our T-cell-engager platform in three therapeutic areas. We appreciate your continued support in advancing our mission of delivering innovative and life-changing medicines to patients.

Speaker Change: Lately, lung cancer is a heterogeneous disease, with patients generally having rapid progression.

David Berman: With lung, we're still in the signal detection phase. Later this year, we plan to share monotherapy in heavily pre-treated lung cancer selected for brain expression, and combinations with late-line chemotherapies enrolled without regard to selection for pre-expression. The next steps are additional combinations with Asimartinib in EGFR mutant patients and with docetaxel, followed by first-line platinum combinations.

Speaker Change: With Lung, we're still in the signal detection phase.

Speaker Change: Later this year, we plan to share monotherapy in heavily pre-treated lung cancer, selected for PREM Expression, and combinations with late-line chemotherapies enrolled without regard to selection for PREM Expression.

Brian Donato: Earlier this year, we outlined our three strategic pillars and our areas of focus for the next 18 to 24 months. Today, we will provide updates on the first two of these pillars. First, we continue to maximize KimTrack performance, continued sequential revenue growth for the quarter, and significant year-over-year growth for the first half of 2024. This growth is driven by strong U.S, performance. We expanded our customer base and increased market penetration and reported longer duration of therapy.

Speaker Change: The next steps are additional combinations with Asim Martinet and the EGFR mutant patients, and with docetaxel. This will then be followed by first-line platinum combinations.

David Berman: Scream is a promising target across multiple tumors, and Vernetta Fusk is a first-in-class claim impact. When you pioneer a novel platform, you have to be ready to look, to learn, and to adjust. And in fact, frankly, this is the exciting part of drug development. We did this for brenetifesp and melanoma, and we'll follow the same thoughtful approach for brenetifesp in ovarian and lung. I will now close by updating you on HIV. HIV is currently managed by antiretroviral therapy.

Speaker Change: FRAME is a promising target across multiple tumors and Brinetta FUSP is a first-in-class FRAME intake.

Unknown Executive: When you pioneer a novel platform, you have to be ready to look, to learn, and to adjust. And, in fact, frankly, this is the exciting part of drug development. But when ART has stopped, the virus rebounds, on average, within two weeks. By week eight, after treatment interruption, 98% of people will have a viral load of at least 200 copies per ml. The MADD portion of the STRIVE study is ongoing.

David Bourbon: When you pioneer a novel platform, you have to be ready to look, to learn, and to adjust. And, in fact, frankly, this is the exciting part of drug development. We did this for Bernetifus and melanoma, and we'll follow the same thoughtful approach for Bernetifus in ovarian and line.

Speaker Change: When you pioneer a novel platform, you have to be ready to look, to learn, and to adjust. And in fact, frankly, this is the exciting part of drug development.

Speaker Change: We did this for bronetifesp and melanoma, and we'll follow the same thoughtful approach for bronetifesp in ovarian and lung.

David Bourbon: I will now close by updating on HIV. HIV is currently managed by anti-retroviral therapy, but when artists stop, the virus rebounds on average within two weeks. By week eight, after treatment interruption, 98% of people will have a viral load of at least 200 copies per ml. This is the threshold commonly used to denote risk for viral transmission. The next frontier in HIV treatment is functional care, where the goal is to reduce or eliminate the viral reservoir, which would then delay or prevent viral rebound. To date, no therapy has convincingly demonstrated either of these endpoints. This is the goal of our 1-1-3-V program called Strive.

David Berman: But when ART has stopped, the virus rebounds, on average, within two weeks. By week eight, after treatment interruption, 98% of people will have a viral load of at least 200 copies per ml. This is the threshold commonly used to denote the risk of viral transmission. The next frontier in HIV treatment is functional care, where the goal is to reduce or eliminate the viral reservoir, which would then delay or prevent viral rebound. To date, no therapy has convincingly demonstrated either of these endpoints. This is the goal of our 1-1-3-D program called STRIVE.

Brian Donato: We also continue to increase our global footprint with additional country launches, allowing us to bring KimTrack to more patients around the world. To achieve our longer-term growth objectives for KimTrack, we are simultaneously pursuing label expansion in both late-lying cutaneous melanoma with the ongoing TAB-EM trial, and also an adjuvant UVO melanoma with the soon-to-start atom trial. It's successful. These two expansions may allow up to 6,000 patients to benefit from the survival benefit of KimTrack.

Speaker Change: i will now close by updating on hiv

Speaker Change: HIV is currently managed by antiretroviral therapy, but when artists stop, the virus rebounds on average within two weeks.

Speaker Change: by week eeightgh after treatment interruption ninety- eight percent of people will have a viral load of at least two hundred copies per ml

Speaker Change: This is the threshold commonly used to denote risk for viral transmission.

Brian Donato: Moving to the second strategic pillar, our aim is to progress our nine clinical programs. All first in class, leading by specific TCR therapies. Innovative research engine to identify additional novel targets and therapeutics. At ASCO, we presented phase one data of preventifus, our premium targeted therapy, and previously treating cutaneous melanoma patients, which drove the decision to start the phase three registration trial in first line cutaneous melanoma patients. Next one that has no, we will present late line ovarian cancer data, and in Q4, we are planning to present late line data in lung cancer at a medical conference.

Speaker Change: The next frontier in HIV treatment is functional care, where the goal is to reduce or eliminate the viral reservoir, which would then delay or prevent viral rebound.

Speaker Change: To date, no therapy has convincingly demonstrated either of these endpoints.

Speaker Change: this is the goal of our one one threev program sal strive

David Bourbon: The mad portion of the Strive study is ongoing. We are treating with 1-1-3-V plus ART for 12 weeks, and then stopping both therapies. The objectives of the study are twofold. First, determine whether we can reduce the viral RNA reservoir during the treatment phase. And second, whether we can delay viral rebound or alter the kinetics of viral rebound after treatment interruption. As of June, we are enrolled 15 people living with HIV across three cohorts, the highest at 300 microbeads. The 300 microbeam dose is biologically active. The next step is to enroll more people living with HIV to better characterize the activity and to explore higher doses.

David Berman: The MADD portion of the STRIVE study is ongoing. We are treating patients with 113V plus ART for 12 weeks and then stopping both treatments. The objectives of this study are two-fold.

Unknown Executive: We are treating with 113V plus ART for 12 weeks and then stopping both therapies to determine whether we can reduce the viral RNA reservoir during the treatment phase. And second, whether we can delay viral rebound or alter the kinetics of viral rebound after treatment interruption. The 300-microgram dose is biologically active, and we should explore higher doses.

Speaker Change: the mad portion of the stcribe study is ongoing

Speaker Change: We are treating with 113V plus ART for 12 weeks and then stopping both therapies.

David Berman: First, determine whether we can reduce the viral RNA reservoir during the treatment phase, and second, whether we can delay viral rebound or alter the kinetics of viral rebound after treatment interruption. As of June, we have enrolled 15 people living with HIV across three cohorts, the highest at 300 micrograms. The 300-microgram dose is biologically active. The next step is to enroll more people living with HIV, to better characterize the activity, and to explore higher doses. This will move the data release into the first quarter of 2025.

Speaker Change: The objectives of this study are twofold. First, determine whether we can reduce the viral RNA reservoir during the treatment phase.

Brian Donato: We are also excited about the potential of our platform to treat infectious diseases. As you recall, our objective is to deliver a functional cure for people living with HIV, and we expect to present the mad data from our HIV trial early next year.

Speaker Change: And second, whether we can delay viral rebound or alter the kinetics of viral rebound after treatment interruption.

Unknown Attendee: I'll now ask in to share additional details.

Speaker Change: As of June , we have enrolled 15 people living with HIV across three cohorts, the highest at 300 micrograms.

Ralph Torbay: First, Ralph will discuss Kentrax commercial performance. Ralph? Thank you, Brian, and hello everyone.

Speaker Change: The 300-microgram dose is biologically active.

Speaker Change: The next step is to enroll more people living with HIV, to better characterize the activity, and to explore higher doses.

David Bourbon: This will move the data at least into the first quarter of 25.

Ralph Torbay: We've had a strong first half in 2024, delivering $146 million in net sales, which represents a 34% increase compared to the same period last year. I'm proud of our cross-functional team's achievements and commitment as we expanded our reach to more patients. We've now launched Kentrax in 19 countries, including nine new launches since the beginning of the year. In the context of a challenging reimbursement environment in Europe, we have made good progress with access, finding two additional reimbursement agreements in Poland and Sweden, which are expected to launch in the fourth quarter.

Speaker Change: this will move the data at lease into the first quarter of twenty-five

David Bourbon: I am very proud of our R&D team. We pioneered the world's first TCR therapeutic. We saw the value of Kim Tract early in phase one, and we followed that version to bring a fantastic new medicine to metastatic uveal melanoma patients. We saw that value for Kim Tract and detainious melanoma and the potential in adjuvant uviel and these programs are underway. We see that value in Bernadifress, and we are excited to follow through on that vision as well.

Brian DiDonato: I'm very proud of our R&D team. We pioneered the world's first TCR therapeutic. We saw the value of ChemTrac early in Phase I, and we followed that vision to bring a fantastic new medicine to metastatic uveal melanoma patients. We saw the value of Kimtrac in cutaneous melanoma and the potential for adjuvant UVL, and these programs are underway. We see that value in Brunetta CRESP, and we are excited to follow through on that vision as well. Brian, I'm going to hand it back to you now.

Speaker Change: I am very proud of our R&D team. We pioneered the world's first TCR therapeutic.

Speaker Change: we saw the value of kimtract early in phase one and we followed that vision to bring a fantastic new medicine to metapatic ubv meanoma patients

Brian: We saw that value for Kimtrak in cutaneous melanoma and the potential in adjuvant UVL and these programs are underway. We see that value in brunetticresp and we are excited to follow through on that vision as well. Brian , I'm going to hand back to you now.

Ralph Torbay: In Q2, we also announced the acceleration over our Phase 312, the Tabby AM Study, in the advancedcutaneous Malanoma. This is an important part of our growth strategy beyond MUM, and we are very pleased with this progress.

Brian Donato: Brian, I'm going to hand back to you now.

Brian Donato: Thank you, David.

Brian Donato: Earlier today, we released our financial results for the second quarter and adjuvant 30 of 2024. Please refer to the press release and our latest SEC filing on Form 10-Q for our full financial results. I'll now share some of the key highlights. In Q2, global Kim Tract unit sales and net sales have both continued to grow sequentially, even with the challenging reimbursement environment in Europe. Net revenue grew to 75.3 million in Q2 from 70.3 million in Q1. The 7% increase driven primarily by the 11% growth in the United States. The U.S. has consistently contributed over 70% of global net sales.

Brian DiDonato: Earlier today, we released our financial results for the second quarter ended June 30, 2024. Please refer to the press release and our latest SEC filing on Form 10-Q for our full financial results. I'll now share some of the key highlights. In Q2, global Chemtrack unit sales and net sales both continued to grow sequentially, even with the challenging reimbursement environment in Europe. Net revenue grew to $75.3 million in Q2 from $70.3 million in Q1. The 7% increase was driven primarily by the 11% growth in the United States. The U.S. has consistently contributed over 70% of global net sales.

Bahija Jallal: Thank you. There are no further questions at this time. I'd like to hand the call back over to Bahija Jallal for closing comments.

Operator: Thank you, operators. So once again, I just want to thank you for your patience, first of all, and continued trust and commitment. And we now close the call. Thank you.

Brian: Thank you, David.

Brian: Earlier today, we released our financial results for the second quarter ended June 30th, 2024.

Brian DiDonato: Please refer to the press release and our latest SEC filing on Form 10-Q for our full financial results. Net revenue grew to $75.3 million in Q2 from $70.3 million in Q1. The 7% increase is driven primarily by the 11% growth in the United States. For the remainder of 2024, we anticipate global unit sales will continue to grow on a sequential basis. As we continue to expect solid demand in the U.S. market and new country contributions from non-U.S. markets, in aggregate, our net loss for the first half of $36.1 million, or $0.72 a share, was roughly unchanged from 2023, given our increase in sales revenue.

Operator: Thank you. This does conclude today's teleconference. We appreciate your participation.

Ralph Torbay: I will now take you through the figures and financial performance in more detail. We delivered $75.3 million in net revenues with Kentrax in the second quarter, which is an increase of 7% compared to the first quarter. Net revenue growth was driven primarily by the US, where we saw an 11% growth compared to the first quarter. This growth comes from our continued focus on the community and increasing duration of therapy. We estimate we now have around 65% market share in the US, and believe there continues to be opportunity for further growth.

Brian: Please refer to the press release and our latest SEC filing on Form 10-Q for our full financial results.

Brian DiDonato: In Q2, we increased rebate reserves by $6.7 million in Europe as we continue to make best estimates revenue recognition assumptions and associated accruals. For the remainder of 2024, we anticipate global unit sales will continue to grow on a sequential basis. As we continue to expect solid demand in the U.S. market and new country contributions from non-U.S. markets, while both SG&A and R&D expenses declined sequentially this quarter, they increased 31% in the first half over the same period in 2023.

Brian: I'll now share some of the key highlights.

Brian: In Q2, global Chemtrail unit sales and net sales have both continued to grow sequentially, even with the challenging reimbursement environment in Europe .

Brian: Net revenue grew to $75.3 million in Q2 from $70.3 million in Q1, a 7% increase driven primarily by the 11% growth in the United States.

Brian: u s has consistently contributed over seventy percent of global net sales

Brian Donato: In Q2, we increased rebate reserves by 6.7 million in Europe as we continue to make best estimate revenue recognition assumptions and associated rules. But the remainder of 2024, we anticipate global unit sales will continue to grow on a sequential basis as we continue to expect solid demand in the U.S. market and new country contributions from non-US markets. While both S-GNA and R&D expenses decline sequentially this quarter, they have increased 31% in the first half over the same period in 2023. We expect R&D expenses to marginally increase in the second half compared to the first half as clinical development for late-stage-prame Kim Tract Phase 3 programs continue to accelerate.

Ralph Torbay: In terms of penetration since launch, over 500 unique sites in the US have treated patients with Kentrax, most in the community. To continue expanding our reach, we are constantly innovating, and recently rolled out our AI-enabled patient-finding tool. This has allowed us to find more patients in lower density community centers, while keeping our field-force footprint unchanged. Our goal is to continue growing the US through further market penetration and appropriately supporting duration of therapy, currently trending to 11 plus months.

Brian: In Q2, we increased rebate reserves by $6.7 million in Europe as we continue to make best estimate revenue recognition assumptions and associated accruals.

Brian: For the remainder of 2024, we anticipate global unit sales will continue to grow on a sequential basis.

Brian: As we continue to expect solid demand in the U.S. market and new country contributions from non-U.S. markets.

Brian: While both SG&A and R&D expenses declined sequentially this quarter, they have increased 31% in the first half over the same period in 2023.

Brian DiDonato: We expect R&D expenses to marginally increase in the second half compared to the first half as clinical development for late-stage PRAME and ChemTrac Phase III programs continue to accelerate. In aggregate, our net loss for the first half of $36.1 million, or $0.72 a share, was roughly unchanged from 2023, given our increase in sales revenue.

Ralph Torbay: This is exceptional, and speaks with different mechanism of action with the benefit of Kentrax extending beyond the typical resist response. Many patients with the best response of stable disease do well and remain on Kentrax years later, contributing to the growing duration of therapy we observe.

Brian: We expect R&D expenses to marginally increase in the second half compared to the first half as clinical development for late-stage PRAME and ChemTrac Phase III programs continue to accelerate.

Brian Donato: In aggregate, our net loss for the first half of 36.1 million, or 72 cents a share, was roughly unchanged from 2023, given our increase in sales revenue. As you can see on this slide, our net cash and marketable securities position increased 860 million as of June 30th. For 770 million, net of the plan 50 million loan repayment and an expected 40 million in European sales rebate payments, both expected in the second half of 24. I'd like to congratulate the teams on continued Kim Tract sales growth as we reach progressively more patients globally. This cash flow enables us to accelerate the broader portfolio while delivering transformative outcomes to patients.

Brian: In aggregate, our net loss for the first half of $36.1 million, or $0.72 a share, was roughly unchanged from 2023, given our increase in sales revenue.

Ralph Torbay: Shifting gears to Europe, demand flattened in Q2, and revenues declined net of 6.7 million increase in rebate reserves. The access environment remains very challenging across Europe, and we expect incremental demand growth in the second half of the year to come from the launches in Poland and Sweden. I'm pleased with our team's effort to reach more patients globally with MUM, driving near-term growth. KimTrack has the potential to benefit patients beyond MUM and drive mid-term growth through label expansion with the TBAAM study.

Brian DiDonato: As you can see on this slide, our net cash and marketable securities position increased to $860 million as of June 30th, or $770 million, net of the plan $50 million loan repayment and an expected $40 million in European sales rebate payments, both expected in the second half of 2024. I'd like to congratulate the teams on continued ChemTrack sales growth as we reach progressively more patients globally. This cash flow enables us to accelerate the broader portfolio while delivering transformative outcomes to patients.

Unknown Executive: As you can see on this slide, our net cash and marketable securities position increased to $860 million as of June 30th, or $770 million, net of the plan's $50 million loan repayment and an expected $40 million in European sales rebate payments, both expected in the second half of 2024. This cash flow enables us to accelerate the broader portfolio while delivering transformative outcomes to patients. For the remainder of 2024, we will be presenting the Brenentafost Phase I Late Line Ovarian data at ESMO and then, in Q4, the initial Phase I Lung data at a medical conference.

Brian: As you can see on this slide, our net cash and marketable securities position increased to $860 million as of June 30th.

Brian: Or $770 million, net of the plan $50 million loan repayment, and an expected $40 million in European sales rebate payments, both expected in the second half of 2024.

Speaker Change: i'd like to congratulate the teams that continued kimtrack sales growth as we reach progressively more patients globally

Brian: This cash flow enables us to accelerate the broader portfolio while delivering transformative outcomes to patients.

Brian Donato: For the remainder of 2024, we will be presenting the Brinentifus Phase 1 late-line ovarian data at SMO and then in Q4, the initial Phase 1 lung data at a medical conference. Looking over the next four years, we expect numerous data readouts, including additional data from Brinentifus, our HIV phase 1 study, and data from our three phase 3 trials with Kim Tract and Brinentifus. and data from several new trial starts across our three therapeutic areas.

Brian DiDonato: For the remainder of 2024, we will be presenting the Brenentafost phase 1 late-line ovarian data at ESMO and then, in Q4, the initial phase 1 lung data at a medical conference. Looking over the next four years, we expect numerous data readouts, including additional data from Bernante Voss. Our HIV phase one study, data from our three phase three trials with ChemTrac and BrnEnterprise, and data from several new trial starts across our three therapeutic areas.

Ralph Torbay: Following a consultation with the FDA, we converted and accelerated our TBAAM study into a phase three registrational trial in second-line plus advanced-cutaneous malnoma. This is exciting and helps us in ways. First, to robustly test the PD1 combination and KimTrack monetary arms. And second, by rolling the 120 patients already enrolled into the phase two, we accelerate the time to final analysis of the phase three by up to 12 months. We now expect to complete the enrollment in the first half of 2026 and potentially see data in the second half, noting of course the event driven nature of the endpoint.

Speaker Change: For the remainder of 2024, we will be presenting the BRNF phase I late-line ovarian data at ESMO, and then in Q4, the initial phase I lung data at a medical conference.

Unknown Executive: Looking over the next four years, we expect numerous data readouts, including additional data from Burnett to Fuss and from our HIV phase one study. Data from our three phase three trials with Chemtrack and Brenentaphas and data from several new trial starts across our three therapeutic areas. With a strong balance sheet, a robust and diversified portfolio, our talented and dedicated teams, and a clear and compelling vision for the future, we are confident we can continue to deliver significantly for patients and shareholders.

Brian: Looking over the next four years, we expect numerous data readouts, including additional data from BRNF, our HIV Phase 1 study,

Brian: Data from our three phase three trials with ChemTrac and BrnEnterprise.

Brian: and data from several new trial starts across our three therapeutic areas.

Brian Donato: With a strong balance sheet, a robust and diversified portfolio, our talented and dedicated teams, and a clear and compelling vision for the future, we are confident we can continue to deliver significantly for patients and shareholders.

Brian DiDonato: With a strong balance sheet, a robust and diversified portfolio, our talented and dedicated teams, and a clear and compelling vision for the future, we are confident we can continue to deliver significantly for patients and shareholders. Thank you.

Brian: With a strong balance sheet, a robust and diversified portfolio, our talented and dedicated teams, and a clear and compelling vision for the future, we are confident we can continue to deliver significantly for patients and shareholders.

Ralph Torbay: Today, we're only at the beginning of the KimTrack journey. In MUM, we're growing KimTrack double-digit year-over-year as we increase our penetration in the U.S, support duration of therapy around the world and launch new markets. Our two ongoing phase three registrational clinical trial positioned us for a continuous growth in the mid to long-term. With the TBAAM trial, we see the potential to extend the benefit of KimTrack to up to 4,000 additional patients with second-line plus metastatic-cutaneous malnoma.

Unknown Attendee: Thank you.

Unknown Attendee: We will now take questions. Thank you. We will now be conducting a question-on-answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your hands that before pressing the star keys. One moment please, while we pull for your question.

Speaker Change: Thank you. We will now take questions.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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 keys.

Speaker Change: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove your question from the queue.

Brian: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions.

Operator: One moment, please, while we poll for your question. Our first question comes from the line of Michael Yee with Jeffries. Please proceed with your question.

Ralph Torbay: With the atom trial, we see this benefit expanded into the adjuvant UVO malnoma setting where all the evidence with KimTrack points to our platform being potentially transformative. If successful, we could help up to 6,000 patients across all three indications, live longer and better lives.

Michael Yee: Our first question comes from the line of Michael Yee with Jeffries. Please proceed with your questions. Hey guys, thanks. Good morning. Congrats on great progress. We have two questions on KimTrack. I know you made a few comments about the challenges, about reimbursement in Europe. Can you just help us understand in the second quarter there what the reserve was for? Was that a specific country? And what does that mean for the go forward, third and fourth quarters? Did we go back to adjusting for that, and was that a one-time reserve? So help us understand the second quarter and then third and fourth quarter adjustments.

Operator: Our first question comes from the line of Michael Yee with Jeffries. Please proceed with your question.

Michael Yee: Hey guys, thanks. Good morning. Congratulations on your great progress.

Speaker Change: Our first question comes from the line of Michael Yee with Jefferies. Please proceed with your questions.

Michael Yee: We have two questions. On Kim Track, I know you made a few comments about the challenges of reimbursement in Europe. Can you just help us understand in the second quarter there what the reserve was for? Was that a specific country?

Michael Yee: Hey guys, thanks. Good morning. Congratulations on your great progress.

Michael Yee: Hey guys, thanks, good morning. Congrats on great progress. We have two questions.

David Berman: I'm very excited about our future and to tell you more, I'll hand over to David. Thank you, Ralph. I'm really pleased to update you on the strong progress we've made on our pipeline. I'm proud of our R&D team. We have hit all our development milestones in progressing nine clinical programs, including three phase three trials, starting three new phase ones, and expanding to three therapeutic areas. Today, I'm going to focus on the two clinical stage programs with data readouts over the next 18 months, Bernadifest and HIV.

Michael Yee: On Chemtrack, I know you made a few comments about the challenges about reimbursement in Europe . Can you just help us understand, in the second quarter there, what the reserve was for? Was that a specific country?

Michael Yee: And what does that mean for the go-forward third and fourth quarters? Do we go back to adjusting for that? And was that a one-time reserve?

Speaker Change: And what does that mean for the go-forward third and fourth quarters? Do we go back to adjusting for that and was that a one-time reserve? So help us understand the second quarter and then third and fourth quarter adjustments.

Michael Yee: To help us understand the second quarter and then third and fourth quarter adjustments. And then on the pipeline, I thought you made a very, very interesting comment about HIV. Can you just expand on that a little bit? You're saying you're enrolling more patients at a higher dose, and it's biologically active. Have you been looking at the prior doses? Is the study all blinded? What are you seeing there? And what gives you that confidence to enroll more patients? Thank you.

Ralph Torbay: And then on the pipeline, I thought you made a very, very interesting comment about HIV. Can you just expand on that a little bit? You're saying you're enrolling more patients out of higher dose, and it's biologically active. Have you been looking at the prior doses? Is the study all blinded? What are you seeing there? And what gives you that confidence to the real patients? Thank you. Thank you, Michael.

Speaker Change: And then on the pipeline, I thought you made a very, very interesting comment about HIV. Can you just expand on that a little bit? You're saying you're enrolling more patients at a higher dose and it's biologically active. Have you been looking at the prior doses?

David Berman: Let's recall our strategy in containers melanoma and the data supporting the phase three trial. The most common therapies used globally are anti-PD1, either as monotherapy, or insect-ling combination, and B-raft therapy for B-raft mutation-positive patients. Once patients progress on these available therapies, the only options are clinical trials and pills for select patients. Our strategy is to demonstrate in the phase one trial in third-line patients that Bernadifest is active and well-calerated, and that this activity would support a TFS endpoint in a phase three trial in first-line.

Speaker Change: Is the study all blinded? What are you seeing there? And what gives you that confidence to enroll more patients? Thank you.

Unknown Executive: Thank you, Michael. Brian or Ralph for the first question and David for the HIV, please.

Michael Yee: We have two questions. On KimTrack, I know you made a few comments about the challenges of reimbursement in Europe. Can you just help us understand in the second quarter there what the reserve was for? Was that a specific country?

David Bourbon: Ryan or Roth for the first question, and David for the HIV, please. Great. Ralph wanted to take your question. Sounds good. Thank you. Thank you, Michael, for the question. So look, we've had successes with reimbursement, as proven by the nine launches that we've had so far in this first half of the year. We increased the estimated reserve by 6.7 million. Sorry. This should be a one-time thing based on the latest assumptions that we have on the negotiations. Now, in terms of looking forward, I would caution you against just adding the 6.7 because the erosion is both backward-looking and forward-looking, and it's mainly on our negotiations with Trans and Germany.

Speaker Change: Thank you, Michael. Brian or Ralph for the first question, and David for the HIV, please.

Unknown Executive: Great. Ralph, why don't you take the European?

Speaker Change: Great. Ralph, why don't you take the European question?

Michael Yee: And what does that mean for the go-forward third and fourth quarters? Do we go back to adjusting for that? And was that a one-time reserve?

Ralph: Sounds good. Thank you. Thank you, Michael, for the question. So look, we've had success with reimbursement as proven by the nine launches that we've had so far in this first half of the year.

David Berman: Here's a summary of the key data from the Phase I trial we presented at ASCO. First, Brenny has monotherapy activity, something not commonly seen for other biologics in heavily pretreated melanoma. Second, the disease control rate, which is a surrogate of progression through survival, is higher for brinetifus monotherapy than the combination of nevolumat plus lyratlamin in a similar setting. Third, we see higher activity in brain positive versus brain negative. This provides biological plausibility as the brain negative subset behaves as an internal negative control.

Speaker Change: We increased the estimated reserves by $6.7 million. This should be a one-time thing based on the latest assumptions that we have on the negotiations.

Speaker Change: Now, in terms of looking forward, I would caution you against just adding the 6.7 because the erosion is both backward-looking and forward-looking, and it's mainly on our negotiations with France and Germany.

David Bourbon: David? Michael, so with the HIV program, we're in the dose escalation phase of the multiple ascending dose, and as mentioned, we've gotten up to 300 micrograms and will continue to dose higher. There's a couple of important firsts that we're looking at. This is the first time we've taken our platform into a setting with such a low peptide target density and where we have such a low, in fact, our cell target density. So it was an important question for us to ask: can we actually see anything? And then, of course, there's never been a functional care.

Michael Yee: So help us understand the second quarter and then third and fourth quarter adjustments. And then on the pipeline, I thought you made a very, very interesting comment about HIV. Can you just expand on that a little bit? You're saying you're enrolling more patients at a higher dose, and it's biologically active. Have you been looking at the prior doses? Is the study all blinded? What are you seeing there? And what gives you that confidence to enroll more patients? Thank you.

Speaker Change: Thank you.

Speaker Change: Michael, so with the HIV program, we're in the dose escalation phase of the multiple ascending dose, and as mentioned, we've gotten up to 300 micrograms and we'll continue to dose higher.

Speaker Change: There's a couple of important firsts here that we're looking at. This is the first time we've taken our platform into a setting with such a low peptide target density and where we have such a low, in fact, you know, cell target density. And so it was an important question for us to ask, can we actually see anything?

David Berman: And finally, the systemic T cell fitness data indicates we expect an even higher disease control rate and longer PFS in first line. These data supported our decision to move to Phase III in first line. In our Phase III first line trial, we will combine two biologics, brinetifus and nevolumat, each with monotherapy activity and with complementary mechanisms of action. Based on the Phase I cross trawl comparison, I just shared with you, we fully expect that brinetifus plus nevolumat in the first line setting will be superior to both nevolumat alone and nevolumat plus relatlamin.

David Bourbon: There's never been a therapy that can reduce the reservoir or delay the rebound. So these are all really important firsts. and we do see evidence of biological activity during the MAD portion, but it's still early, and there are only a few patients per court, and so we think it's prudent to get some more patients in that court and also to continue to go higher.

Speaker Change: And then of course, there's never been a functional care, there's never been a therapy that can reduce the reservoir or delay the rebound. So these are all really important first.

David Berman: And we do see evidence of biological activity during the MAD portion, but it's still early, and there are only a few patients per cohort. And so we think it's prudent to get some more patients in that cohort and also to continue to go higher. We will discuss more of what biological activity means as we approach the full data release, which will be in the first quarter of next year.

Speaker Change: And we do see evidence of biological activity during the MAD portion, but it's still early, and there are only a few patients per cohort, and so we think it's prudent.

David Bourbon: We will discuss more of what biological activity means as we approach the full data release, which will be in the first quarter of next year. Thank you.

Speaker Change: We will discuss more of what biological activity means as we approach the full data release, which will be in the first quarter of next year.

David Berman: We are pleased to announce that the Phase III Prism Mel 3.01 study has started, and we are focused on activating more sites globally. With the Prism Mel 3.01 in first line, I just shared, and with the TV AM in second line that Ralph shared, we are really proud to be one of the few companies to have multiple Phase III investments incutaneous melanoma, both backed by strong data.

Bahija Jallal: Thank you, Michael. Brian or Ralph for the first question and David for the HIV, please.

Brian DiDonato: Great. Ralph, why don't you take the European? Sounds good. Thank you.

Ralph Torbay: Sounds good. Thank you. Thank you, Michael, for the question. So, look, we've had successes with reimbursement, as proven by the nine launches that we've had so far in this first half of the year. We increased the estimated reserves by 6.6, 6.7 million. Sorry. This should be a one-time thing based on the latest assumptions that we have in the negotiations. Now, in terms of looking forward, I would caution you against just adding the 6.7, because the erosion is both backward looking and forward looking, and it's mainly in our negotiations with France and Germany.

David Berman: Michael, so with the HIV program, we're in the dose escalation phase of the multiple ascending dose. And as mentioned, we've gotten up to 300 micrograms and will continue to dose higher. There are a couple of important firsts here that we're looking at.

David Berman: This is the first time we've taken our platform into a setting with such a low peptide target density and where we have such a low, in fact, you know, cell target density. And so it was an important question for us to ask, can we actually see any There's never been a therapy that can reduce the reservoir or delay the rebound.

Jessica Fye: Our next questions come from the line of Jessica Fye with JP Morgan. Please proceed with your questions. This is Nick on for Jess. Thanks for taking your questions. First, on the Breni Sovereign Update, we should expect a nice amount.

Speaker Change: anandalyzing thank you

Speaker Change: Thank you. Our next question is coming from the line of Jessica Fye with J.P. Morgan. Please proceed with your questions.

Operator: Hey, this is Nick on behalf of Jeff. Thanks for taking our questions. First, on the brain ovarian update, we should expect it as well. Can you just help set the stage for how many patients with the data we should expect a kind of split between mono and combo that I believe you stated should be more combo. And maybe add some more detail around what we see is promising data that supports continued evaluation here in the setting based on some of those benchmarks you provided.

David Berman: So these are all really important first steps, and we do see evidence of biological activity during the MAD portion, but it's still early, and there are only a few patients per cohort. And so we think it's prudent to get some more patients in that cohort and also to continue to go higher. We will discuss more about what biological activity means as we approach the full data release, which will be in the first quarter of next year.

Nick: Hey, this is Nick on for Jess. Thanks for taking our questions. First, on the brain ovarian update, we should expect the desmo. Can you just help set the stage for how many patients worth of data we should expect, kind of the split between mono and combo, though I believe you stated should be more combo. And maybe add some more detail around what we see is promising data that supports continued evaluation here in the setting based on some of those benchmarks you provided?

David Berman: Thank you.

David Bourbon: Can you just help set the stage for how many patients work a day and we should expect kind of split between mono and combo, though I believe you stated, should be more combo. And maybe add some more detail around what you see as promising data that supports continued evaluation here in the setting based on some of those benchmarks you provided. Yeah, happy to say in terms of size, it's going to be roughly the same number as the continuous melanoma data set at ASCO. It will be mostly monotherapy, but in contrast to the ASCO melanoma, we will have more combinations because there's more chemotherapy options to test here, so we'll be mostly mono with combination as well in terms of the questions that we're going to be asking.

David Berman: I will now turn to brinetifus and ovarian cancer. Women with ovarian carcinoma are cycled through platinum regiments, shown in the blue, until they become resistant or refractory, shown in the green, at which point they receive non-platinum chemotherapies or for the folate alpha receptor positive tumors and a body drug conjugate. Unlike melanoma, ovarian cancer has historically not been sensitive to immunotherapy. In heavily pre-treated platinum resistance, which is the population in our Phase I trial, the outlook is poor, with non-platinum therapies having response rates less than 10% and disease control rates between 40 to 50%.

Speaker Change: Yeah, happy to. So in terms of size, it's going to be roughly the same number as the cutaneous melanoma dataset at ASCO.

Speaker Change: It will be mostly monotherapy, but in contrast to the ASCO melanoma, we will have more combinations because there's more chemotherapy options to test here. So we'll be mostly mono with

Speaker Change: Combination as well. In terms of the questions that we're going to be asking,

David Bourbon: So, number one is on these are the standard questions, you know, I've been asking throughout my drug development career in the stage. Is there monitor activity? Can you combine with the intended registration partner if you plan to do a combination, and can you have confidence that the drug activity can meet whatever. So, those are the types of questions we're asking in order to progress in terms of the metrics or the benchmarks. I think you were asking. Yes, so there aren't a lot of good benchmarks in this heavily retreated platinum resistance setting or a few published chemotherapy trials.

Speaker Change: so

Speaker Change: Number one is, and these are the standard questions, you know, I've been asking throughout my drug development career in the States. Is there monotherapy activity?

Speaker Change: Can you combine with the intended registrational partner if you plan to do a combination?

Speaker Change: Can you have confidence that the drug activity can meet whatever registrational end point? So those are the types of questions we're asking.

David Berman: In our Phase I trial, we aim to demonstrate in the platinum resistance setting that brinetifus is clinically active and can be combined with non-platinum chemo. This will be the subject of our Esmo poster next month. We have learned for our platform that clinical benefit manifests as disease control that activity is even higher in early aligns and that combined ability with standards of care may enable at least additive activity. In addition, unlike melanoma, ovarian cancer is more complex, with two distinct disease segments that are treated very differently, which requires us to study more combination.

Speaker Change: In order to progress.

Speaker Change: In terms of the metrics or the benchmarks, I think you were asking, yes, so there aren't a lot of good benchmarks in this heavily pre-treated platinum resistance setting. There are a few published chemotherapy trials.

David Bourbon: And so the chemotherapy benchmarks there, the response rates are in the single digits and the disease control rates are about 40 to 50%.

Speaker Change: And so the chemotherapy benchmarks there, the response rates are in the single digits and the disease control rate is about 40 to 50 percent.

David Bourbon: Great. And then, in addition to evaluating, bringing the platinum resistance in varying cancer patients, you noted some evaluation, the platinum sensitive setting as well. So, you can try a little more detail, the progress there and when we kind of expect an update from that they've said. So, how many do you want to take that? Sure, kind of happy to do that. So, as David mentioned, obviously, you know, varying is more heterogeneous and complex than melanoma. So, we've been exploring mostly in the platinum resistance setting, but now the study does allow us to move to earlier lines and combine with therapies that are used in sensitive, and those include that and also will include platinum double.

Operator: And then, in addition to evaluating platinum-resistant ovarian cancer patients, you noted some evaluation in the platinum-sensitive setting as well. So, you know, can you provide a little more detail on the progress there and when we kind of expect an update from that data set?

Speaker Change: Great. And then in addition to evaluating the platinum-resistant ovarian cancer patients, you noted some evaluation in the platinum-sensitive setting as well. So can you provide a little more detail on the progress there and when we kind of expect an update from that data set?

David Berman: Therfore, our next step in Ovarian is twofold. First, in the heavily pre-treated platinum-resistant disease, we will expand our patient data set of combinations with non-platinum chemotherapy. And second, in the earlier line platinum-sensitive disease setting, we will test the combinations with devisism app and with platinum chemotherapy.

Mohammed: Mohammed, do you want to take that? Sure, happy to do that. So, as David mentioned, obviously, you know, ovarian is more heterogeneous and complex than melanoma, so we've been exploring mostly in the platinum-resistant setting, but now the study does allow us to move to earlier lines and combine with therapies that are used in the toxin-sensitive, and those include Bev, and also will include platinum doublet.

David Bourbon: Great, thank you. Thank you.

David Berman: Let's now turn to line cancer. Clayline line cancer is a heterogeneous disease, with patients generally having rapid progression. With line, we're still in the signal detection phase. Later this year, we plan to share monotherapy in heavily pre-treated line cancer, selected for premium expression, and combinations with the late line chemotherapies enrolled without regard to selection for premium expression. The next steps are additional combinations with Aussie-Martinith in the Egypthar mutants, patients, and with those attacks.

Jessica Fye: Thank you. Our next question is coming from the line of Jessica Fye with J.P. Morgan. Please proceed with your questions.

Tyler Van Buren: Our next question comes from the line of Tyler Van Buren with TD Cowan. Please proceed with your question. Hey guys, good morning. Thanks very much for the presentation. I have a couple follow-ups on the ovarian updated ESMO. So, I understand that the bar for beating non-platinum, chemo, and platinum-resistant patients is low. But for the Brenny combo, a chemo combo specifically isn't Ella here or Mervatux mab data of the bar. And then the second question is if you can combine with non-platinum chemo with good safety, do you believe that the likelihood of combining with platinum chemo in the front line with platinum-sensitive patients is high?

Speaker Change: Great, thank you.

Nick: Hey, this is Nick on behalf of Jess. Thanks for taking our questions. First, on the brain ovarian update, we should expect it as well. Can you just help set the stage for how many patients' worth of data we should expect a kind of split between mono and combo, though I believe you stated it should be more combo. And maybe add some more detail around what we see as promising data that supports continued evaluation here in the setting based on some of those benchmarks you provided.

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

Operator: Hey guys, good morning.

Operator: Thanks very much for the presentation. I have a couple follow-ups on the ovarian updated ESMO. So I understand that the bar for beating non-platinum chemo and platinum-resistant patients is low. But for the BRENNY chemo combo specifically, isn't the Elahir or Mervitoximab data the bar? And then the second question is, if you can combine it with non-platinum chemo with good safety, do you believe that the likelihood of combining it with platinum chemo in the front line with platinum-sensitive patients is high?

Speaker Change: Hey guys, good morning. Thanks very much for the presentation. I have a couple follow-ups on the ovarian update at ESMO. So I understand that the bar for beating non-platinum chemo and platinum resistant patients is low.

Speaker Change: But for the brony combo, chemo combo specifically,

Speaker Change: Isn't Ella here or Mervitux mad?

Speaker Change: Data, The Bar. And then the second question is, if you can combine with non-platinum chemo with good safety, do you believe that the likelihood of combining with platinum chemo in the frontline with platinum sensitive patients is high?

David Berman: This will then be followed by first line platinum combinations. Premium is a promising target across multiple tumors, and Bernetifus is a first-ing-class premium tech. When you pioneer a novel platform, you have to be ready to look, to learn, and to adjust, and in fact, frankly, this is the exciting part of drug development. We did this for Bernetifus and melanoma, and we'll follow the same thoughtful approach for Bernetifus in Ovarian and Lyme.

David Berman: So in terms of size, it's going to be roughly the same number as the cutaneous melanoma data set at ASCO. It will be mostly monotherapies, but in contrast to the ASCO melanoma data set, we will have more combinations because there are more chemotherapy options to test here. So we'll be mostly monotherapies with combinations as well. In terms of the questions that we're going to be asking, number one is, and these are the standard questions that I've been asking throughout my drug development career in the States: is there monotherapy activity?

David Berman: David and Mohammed. Yeah, so I'll address the first one, and then Mohammed, you can talk about the plot.

David Bourbon: Yeah, so I'll address the first one, and then, Mohammed, you can talk about that. So, Tyler, the Merva, it's good to see that there's a new medicine for these patients, and it's, you know, not, you know, this Merva is a targeted chemotherapy. We know that chemotherapy is the work there, so the key differences, I would say, Tyler, for us, is that the Merva strategy is in the p-rock. Our setting is for place chemotherapy; our strategy is to add on chemotherapy, not to replace chemotherapy. And so, our approach is going to be an add-on to chemotherapy, and of course, eventually, they also could be an add-on to Merva texture map as well.

Speaker Change: David and Mohammed. Yeah, so I'll address the first one and then Mohammed you can talk about the plot. So Tyler,

David Berman: Can you combine with the intended registrational partner if you plan to do a combination? And can you have confidence that the drug activity can meet whatever registrational endpoint? So those are the types of questions we're asking in order to progress.

David Berman: So Tyler, MIRVA, it's good to see that there's a new medicine for these patients, and it's not, you know, this MIRVA is targeted chemotherapy. We know chemotherapies do work there. So, the key differences, I would say, Tyler, for us are that the MIRVA strategy in the P-ROC setting is to replace chemotherapy. Our strategy is to add on chemotherapy, not replace chemotherapy. And so, our approach is going to be an add-on to chemotherapy, and, of course, eventually, there could also be an add-on to MIRVA, Texanrap, as well.

David Berman: In terms of the metrics or the benchmarks, I think you were asking, yes, so there aren't a lot of good benchmarks in this heavily pretreated platinum-resistant setting. There are a few published chemotherapy trials. And so for the chemotherapy benchmarks there, the response rates are in the single digits, and the disease control rate is about 40 to 50 percent.

Speaker Change: The MRVA, it's good to see that there's a new medicine for these patients, and it's, you know, not, you know, this MRVA is a targeted chemotherapy. We know chemotherapies do work there, so the key differences, I would say, Tyler, for us is that the MRVA

David Berman: I will now close by updating on HIV. HIV is currently managed by anti-retroviral therapy, but when artists stop, the virus rebounds on average within two weeks. By week eight, after treatment interruption, 98% of people will have a viral load of at least 200 copies per ml. This is the threshold commonly used to denote risk for viral transmission. The next frontier in HIV treatment is functional care, where the goal is to reduce or eliminate the viral reservoir, which would then delay or prevent viral rebounds.

Mohammed: The basic strategy in the PROC setting is to replace chemotherapy. Our strategy is to add on to chemotherapy, not to replace chemotherapy. And so our approach is going to be an add-on to chemotherapy and of course, eventually it also can be an add-on to myrtidexamab as well.

David Berman: And then, in addition to evaluating brain and platinum-resistant ovarian cancer patients, you noted some evaluation in the platinum-sensitive setting as well. So, you know, can you provide a little more detail about the progress there and when we kind of expect an update from that data set?

David Bourbon: I'm joining comments on the sensitive. Sure, happy to do that. So, I would say, Tyler, you know, this is early days. This is the first time we're actually combining our platform with chemotherapy, and we're learning, but so far, you know, the expectations that we should be able to combine, and the plan is to then move from the non-platinum-based chemotherapies to the platinum-based chemotherapies over the coming months into next year. Thank you.

Mohammed Dar: Sure, happy to do that. So, I would say, Tyler, this is the early days. This is the first time we're actually combining our platform with chemotherapy, and we're learning, but so far, the expectations that we should be able to combine, and the plan is to then move from non-platinum based chemotherapies to platinum-based chemotherapies over the coming months and into next year.

Mohammed Dar: Sure, happy to do that. As David mentioned, obviously, ovarian cancer is more, you know, more heterogeneous and complex than melanoma. So we've been exploring mostly in the platinum-resistant setting. But now, the study does allow us to move to earlier lines and combine with therapies that are used in the platinum sensitive setting, and those include BEV, and also will include platinum double.

Mohammed Dar: Mohammed, do you want to take that? Sure. I'm happy to do that.

Speaker Change: Do you want to comment on the fat number sensitivity?

Speaker Change: Sure. Happy to do that. So, I would say, Tyler, you know, this is early days. This is the first time we're actually combining our platform with chemotherapy and we're learning. But so far, you know, the expectations that we should be able to combine and the plan is to then move from the non-platinum-based chemotherapies to the platinum-based chemotherapies over the coming months and into next year.

David Berman: To date, no therapy has convincingly demonstrated either of these endpoints. This is the goal of our 1-1-3-V program called strive. The mad portion of the strive study is ongoing. We are treating with 1-1-3-V plus art for 12 weeks, and then stopping both therapies. The objectives of the study are two-fold. First, determine whether we can reduce the viral RNA reservoir during the treatment phase. Second, whether we can delay viral rebound or alter the kinetics of viral rebound after treatment interruption.

Operator: Thank you. Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please proceed with your question.

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

Eric Schmidt: Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please proceed with your question. Well, thanks for taking my question. Maybe back to KimTrack for a moment. It sounds like you've crossed the $300 million annualized run rate for the first time. You've grown now for several quarters at 30% or more year on year. You've spoken of more patients out there than you thought previously, and longer duration, of course, than you would assume. So, I guess the question is, what's the ceiling for this drug in the car? You feel no more indication? Do you think it's a 500, 600, 700?

Tyler: Thank you.

Speaker Change: Thank you. Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please proceed with your question.

Eric Schmidt: Well, thanks for taking my question. Maybe we'll go back to Tim Track for a moment.

Eric Schmidt: Well, thanks for taking my question. Maybe back to Kim track for a moment. It sounds like you've crossed the $300 million annualized run rate for the first time. You've grown now for several quarters at 30% or more year on year.

Unknown Executive: It sounds like you've crossed the $300 million annualized run rate for the first time. You've grown now for several quarters at 30% or more year on year. You've spoken to more patients out there than you thought previously, and for a longer duration, of course, than you would assume. So I guess the question is, what's the ceiling for this drug in the current uveal melanoma indication? Do you think it's a $500, $600, $700 million drug? Where is this going to end?

Speaker Change: You've spoken to more patients out there than you thought previously, and longer duration, of course, than you would assume. So, I guess the question is, what's the ceiling for this drug in the current uveal melanoma indication? Do you think it's a 500, 600, 700 million dollar drug? Where's this going to end?

Ralph Torbay: I don't know how drug worse is going to end. Thank you, Eric.

David Berman: As of June, we are enrolled 15 people living with HIV across three cohorts, the highest at 300 microbeads. The 300 microbeam dose is biologically active. The next step is to enroll more people living with HIV to better characterize the activity and to explore higher doses. This will move the data at least into the first quarter of 25.

Ralph Torbay: Well, if you want to take that and maybe blind, you can comment also at the end. Happy to. Thank you, Eric, for the question. So, look, we're very proud of the growth that we've had. A lot of it has been driven, as we've stated, by the U.S. growth where we're 65% penetrated. It's important to keep in mind to ask it.

Speaker Change: Thank you, Eric. Ralph, do you want to take that? And maybe, Brian, you can comment also at the end.

Ralph: Happy to.

Ralph: Thank you, Eric, for the question. So, look, we're very proud of the growth that we've had. A lot of it has been driven, as we stated, by the U.S.

Ralph: Growth, where we're 65% penetrated. It's important to keep in mind two aspects. One is...

Ralph Torbay: One is the reimbursement landscape in Europe is such and the challenges are such that we expect really minor to very incremental growth coming from Europe moving forward. So, a lot of the growth will be driven by the U.S. A lot of the incremental growth will be driven by the U.S. That's for MUM. But really, I think where we get very much excited is when we think about the label expansions that are possible with a tab A and study, which is expect, which expects data in 2026, as I mentioned. And from the atom study a little bit further down the line, and that also bring would bring us into the adjuvant setting, bring the platform to the adjuvant setting.

David Berman: I am very proud of our R&D team. We pioneered the world's first TCR therapeutic. We saw the value of Kim Tract early in phase 1, and we followed that version to bring a fantastic new medicine to metastatic uviel melanoma patients. We saw that value for Kim Tract and detainious melanoma and the potential in adjuvant uviel and these programs are underway. We see that value in Bernadifress and we are excited to follow through on that version as well.

Brian: The reimbursement landscape in Europe is such and the challenges are such that we expect really minor to very incremental growth coming from Europe moving forward. So a lot of the growth will be driven by the US, a lot of the incremental growth will be driven by the US.

Unknown Executive: That's for MUM. But really, I think where we get very excited is when we think about the label expansions that are possible with the TEB-EAM study, which expects data in 2026, as I mentioned.

Ralph: That's for MUM. But really, I think where we get very much excited is when we think about the label expansions that are possible with the TEBI-AM study, which expects data in 2026, as I mentioned.

Brian Donato: Brian, I'm going to hand back to you now. Thank you, David.

Ralph: From the ATOM study, a little bit further down the line, that also would bring us into the adjuvant setting, bring the platform to the adjuvant setting.

Brian Donato: Earlier today, we released our financial results for the second quarter and adjuvant 30 of 2024. Please refer to the press release and our latest SEC filing on form 10Q for our full financial results. I'll now share some of the key highlights. In Q2, global Kim Tract unit sales and net sales have both continued to grow sequentially, even with the challenging reimbursement environment in Europe. Net revenue grew to 75.3 million in Q2 from 70.3 million in Q1.

Ralph Torbay: So, I think there is still significant growth for Kim truck up to 6000 patients, but then should benefit from it. Well, the only thing I'd add, Eric, is that we're really pleased that, given the survival benefit of Kim track, the duration of therapy continues to extend. The mean duration of therapy is now. Over 11 months approaching 12 months, maybe plus, and as patients stay on longer and the tail is pronounced, as we see in the three or survival follow-up, it's still unclear how long the duration of therapy can extend. So, that's one of the upside potentials in Kim track.

Ralph: So, I think there is still significant growth for ChemTrac, up to 6,000 patients potentially benefiting from it.

Unknown Executive: Ralph and Brian, do you want to add anything?

Speaker Change: grow gi going to add

Ralph: Yeah, the only thing I'd add, Eric, is that we're really pleased that given the survival benefit of ChemTrac, that the duration of therapy continues to extend, the mean duration of therapy is now.

Speaker Change: Know over 11 months, approaching 12 months maybe plus, and as patients stay on longer and the tail is pronounced as we see in the three year survival follow up, it's still unclear how long the duration of therapy can extend. So that's one of the upside potentials in in chemistry.

Brian Donato: The 7% increase driven primarily by the 11% growth in the United States. The US has consistently contributed over 70% of global net sales. In Q2, we increased rebate reserves by 6.7 million in Europe as we continue to make best estimate revenue recognition assumptions and associated rules. But the remainder of 2024, we anticipate global unit sales will continue to grow on a sequential basis as we continue to expect solid demand in the US market and new country contributions from non-US markets.

Ralph Torbay: And as Ralph said, 73% of net sales are coming from the United States. We'd expect that to continue going forward. Thank you.

Speaker Change: And as Ralph said, you know, 73% of net sales are coming from the United States. We'd expect that to continue going forward.

Michael Schmidt: Our next question comes from the line of Michael Schmidt with Duggenheim. Please proceed with your question. Hey guys, thanks for taking my question.

Ralph: Thank you.

Speaker Change: thank you our next question comes from the line of michael chmt with bugenham please perceive your question

Tyler Van Buren: Hey guys, good morning. Thanks very much for the presentation. I have a couple of follow-ups on the ovarian updated ESMO. So I understand that the bar for beating non-platinum chemo and platinum-resistant patients is low, but for the BRENNY chemo combo specifically, isn't Elahir or Mervitoximab data the bar? And then the second question is, if you can combine it with non-platinum chemo with good safety, do you believe that the likelihood of combining it with platinum chemo in the frontline with platinum-sensitive patients is high?

Operator: Hey guys, thanks for taking my questions. I have another one for David just on the PREIM program again.

David Bourbon: I have another one for David just on the praying program again. Could you just provide us video updates on the opportunity in the lung cancer indication. Other, any particular patient substance and focus for the device.

michael chmt: Hey guys, thanks for taking my questions. I have another one for David just on the PRAME program again.

Operator: Could you just provide us with your updated views on the opportunity in the lung cancer indication? Are there any particular patient groups and focus for the development strategy? Are you enriching certain patients into this cohort? Any particular genotypes perhaps that might benefit most from PREIM in lung cancer? And what should expectations be for the scope of that data readout later this year?

Brian Donato: While both S-GNA and R&D expenses decline sequentially this quarter, they have increased 31% in the first half over the same period in 2023. We expect R&D expenses to marginally increase in the second half compared to the first half as clinical development for late stage frame and Kim Tract phase 3 programs continue to accelerate. In aggregate, our net loss for the first half of 36.1 million or 72 cents a share was roughly unchanged from 2023 given our increase in sales revenue.

David Berman: Thanks so much.

michael chmt: Could you just provide us with your updated views on the opportunity in the lung cancer indication? Are there...

David Bourbon: The government strategy, are you enriching certain patients into this cohort, any particular genotypes perhaps that might benefit most from praying in lung cancer and what should expectations be for the scope of that data read out later this year. Thanks so much. Yeah, thanks, Michael.

Speaker Change: Any particular patient subsets and focus for the development strategy, are you enriching certain patients into this cohort? Any particular genotypes perhaps that might

michael chmt: benefit most from PREM and lung cancer and what should expectations be for the scope of that data readout later this year. Thanks so much.

David Berman: David and Mohammed. Yeah, so I'll address the first one, and then Mohammed, you can talk about the plot.

David Berman: Yeah, yeah, thanks, Michael. So lung cancer, of course, you know, it's a lot more heterogeneous disease on multiple levels than ovarian and melanoma. And so we have been very interested in looking at those key subsets in order to first see the initial signal before we expand. So, you know, one example of a key subset, of course, are our actionable gene mutation positive patients because those are insensitive to checkpoints. And so that would make an interesting place for us to look, but there are other potential subsets as well.

David Berman: So, Tyler, MIRVA, it's good to see that there's a new medicine for these patients, and it's not, you know, this MIRVA is targeted chemotherapy. We know chemotherapies do work there. So, the key differences, I would say, Tyler, for us, is that the MIRVA strategy in the P-ROC setting is to replace chemotherapy. Our strategy is to add on chemotherapy, not replace chemotherapy. And so, our approach is going to be an add-on to chemotherapy, and, of course, eventually, it also could be an add-on to MIRVA-Texas as well. Do you want to comment on platinum sensitivity? Sure, I'd be happy to do that, I would say.

David Bourbon: So with lying, of course, you know, it's a lot more heterogeneous disease on multiple levels than are very in and melanoma. And so we have been very interested in looking at those key substances in order to first see the initial signal before we stand. So, you know, one example of the key substance, of course, our. Our actionable gene mutation positive patients because those are in sense that to check for instance, so that would make an interesting place for us to look that there are other potential self sets as well. We have initially for the monotherapy, as I talked about in the presentation, we focused on enrolling praying positive because about half of the ad note.

Brian Donato: As you can see on this slide, our net cash and marketable securities position increased 860 million as of June 30th. For 770 million, net of the plan 50 million loan repayment and an expected 40 million in European sales rebate payments, both expected in the second half of 24. I'd like to congratulate the teams on continued Kim Tract sales growth as we reach progressively more patients globally. This cash flow enables us to accelerate the broader portfolio while delivering transformative outcomes to patients.

Speaker Change: yes thanks michael so with lying of course it's a lot more heitterogeneous disease on multiple levels than ovveryian and

Speaker Change: melanona and so we have been very interested in looking at those key subsets in der to first to the initial signal before we stand so one example of the key subset of course are

michael chmt: our actionable gene mutation positive patients because those are in sense that the to check fks and so that would make an interesting place for us to look but there are other potential subsets as well we have initially for the monotherapy as i talked about in the presentation we focused

David Berman: We initially for monotherapy, as I talked about in the presentation, we focused on enrolling pre- and positive patients because about half of the adenocarcinoma patients are pre- and negative; half are positive. And for the initial signal, of course, we want to make sure that the patients are pre- and positive. And so we have been doing this double screening, looking for the right patients. And so the monotherapy data later this year will be smaller, probably than what we're seeing for ovarian and for melanoma, but it's a little too soon to guide to the numbers for that.

Brian Donato: For the remainder of 2024, we will be presenting the Brinentifus phase 1 late line Ovarian data at SMO and then in Q4, the initial phase 1 lung data at a medical conference. Looking over the next four years, we expect numerous data readouts, including additional data from Brinentifus, our HIV phase 1 study, data from our 3 phase 3 trials with Kim Tract and Brinentifus, and Data from several new trial starts across our three therapeutic areas.

David Bourbon: I don't know, I don't know; of course, no patients are praying negative, half a positive, and fully initial signal. Of course, you want to make sure that the patients are praying positive, and so we've been doing this double screening, looking for the right patients and so.

michael chmt: on enrolling PREEM positive because about half of the adenocarcinoma patients are PREEM negative half are positive and for the initial signal of course we want to make sure that the patients are PREEM positive and so we have been doing this double screening looking for the right patients and so

David Bourbon: The monotherapy data later this year will be a smaller, probably than what we're seeing for a variant and from melanoma, but it's a little too soon to guide to the numbers of that. The combinations, of course, is where we're all so interested because that's where we believe our platform is going to work best in terms of combination. So it will be a monotherapy, and it will be a mostly chemotherapy combination initially, as I talked about Michael going to the next year. We expect to move into earlier lines with the dosy taxable combination and with the RC merchant combination.

Speaker Change: Monotherapy data later this year will be smaller probably than what we're seeing for ovarian and for melanoma, but it's a little too soon to guide to the numbers of that. The combinations, of course, is where we're also interested because that's where we believe our platform is going to work best in terms of

David Berman: The combinations, of course, are where we're also interested because that's where we believe our platform is going to work best in terms of combination. So it will be a monotherapy, and it will be mostly a chemotherapy combination. Initially, as I talked about, Michael, going into next year, we expect to move into earlier lines with the DOSI-Taxel combination and with the RC-MRTNF combination. Mohamed, anything you want to

Mohammed Dar: Sure. Happy to do that. So, I would say, Tyler, this is early days. This is the first time we're actually combining our platform with chemotherapy, and we're learning. But so far, the expectations that we should be able to combine, and the plan is to then move from non-platinum-based chemotherapies to platinum-based chemotherapies over the coming months and into next year.

Tyler Van Buren: Thank you. Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please proceed with your question.

Mohammed: combination. So it will be a monotherapy and it will be a mostly chemotherapy combination initially. As I talked about, Michael, going into next year, we expect to move into earlier lines with the Dosey-Taxwell combination and with the Oxymertinib combination. Mohammed, anything you want to add?

Unknown Attendee: We will now take questions. Thank you. We will now be conducting a question-on-answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment and maybe necessary to pick up your hands that before pressing the star keys, one moment please while we pull for your question.

David Bourbon: Mohammed, anything you want to add? No, I guess we also have chemo platinum-based chemotherapy options that will come a little bit later after OC and dosy. Thank you.

Mohammed Dar: No, I guess we will also have chemo, platinum-based chemotherapy options. That will come a little bit later after OC and DOS. Great, thank you.

Mohammed: Now, I guess we also will have chemo, platinum-based chemotherapy options. That will come a little bit later after OCM does.

Eric Schmidt: Well, thanks for taking my question. Maybe we'll go back to Tim Track for a moment.

Eric Schmidt: Thank you, Eric. Ralph, do you want to take that? And maybe Brian, you can also comment at the end.

Jack Allen: Our next question comes from the line of Jack Allen with Baird. Please proceed with your question. Thanks a lot for hearing the question, and congratulations on the progress. I wanted to ask a little bit about the earlier stage pipeline. I know the pill will program recently cleared CTA and is expected to enter the clinic in the second half of this year. And you also submitted the CTA for the half-life extended frame and have plans to submit the CTA for the frame a two four program. I guess my question here is when can we start to see the pipeline kind of build out and see critical data from some of these earlier assets.

Mohammed: great thank you

Speaker Change: thank you our next question comes from the linewn and jack allen with b please proceive your question

Eric Schmidt: It sounds like you've crossed the $300 million annualized run rate for the first time. You've grown now for several quarters at 30% or more year on year. You've spoken to more patients out there than you thought previously, and for a longer duration, of course, than you would assume. So I guess the question is, what's the ceiling for this drug in the current indication for uterine melanoma? Do you think it's a $500, $600, $700 million drug? Where is this going to end?

Michael Yee: Our first question comes from the line of Michael Yee with Jeffries. Please proceed with your questions. Hey guys, thanks. Good morning. Congrats on great progress. We have two questions. On Kim Track, I know you made a few comments about the challenges, about reimbursement in Europe. Can you just help us understand in the second quarter there what the reserve was for? Was that a specific country? And what does that mean for the go-forward, third and fourth quarters?

Speaker Change: Thanks so much for taking the question and congratulations on the progress.

Speaker Change: i wanted to ask a bitabout the earlier stage pipeline and know the pilwill program recently cleared c is expect to dent to the clinic in the second half year and you also submitted the cta for the half-life extended prame and have planned to

Speaker Change: Submit the CTA for the PRAME 824 program. I guess my question here is when can we start to see the the pipeline kind of build out and see clinical data from some of these earlier assets?

Michael Yee: Do we go back to adjusting for that and was that a one-time reserve? So help us understand the second quarter and then third and fourth quarter adjustments. And then on the pipeline, I thought you made a very, very interesting comment about HIV. Can you just expand on that a little bit? You're saying you're enrolling more patients out of higher dose and it's biologically active. Have you been looking at the prior doses?

Mohammed Dar: Great. Thank you, Jack.

Unknown Executive: Great. Thank you, Jack and Mohammed.

Ralph Torbay: Thank you, Eric, for the question. So, look, we're very proud of the growth that we've had. A lot of it has been driven, as we've stated, by U.S. growth, where we're 65% penetrated. But it's important to keep in mind two aspects. One is The reimbursement landscape in Europe is such, and the challenges are such, that we expect really minor to very incremental growth coming from Europe moving forward. So a lot of the growth will be driven by the U.S., and a lot of the incremental growth will be driven by the U.S. That's for MUM.

Mohammed Dar: Mohammed. Thanks for the question, Jack. So you're absolutely right. We're quite excited about the progress we're making with the early early stage pipeline. So for P will following submission, we're now in the stage of activating sites. And then hopefully we'll be able to meet our target of enrolling the first station before the end of the year with HLE. We've made the submission. So it's, you know, we're waiting for health authority feedback. And with a 24, we remain on track for making the health 30 submissions by the end of the year in terms of data. I mean, this is these are first human trials, right?

Ralph Torbay: But really, I think where we get very excited is when we think about the label expansions that are possible with the TEB-AEM study, which expects data in 2026, as I mentioned, from the Atom Study, a little bit further down the line, and that also would bring us into the adjuvant setting, bring the platform to the adjuvant setting. So I think there is still significant growth for ChemTrac, up to 6,000 patients potentially

Operator: Yeah, thanks for the question, Jack. You're absolutely right.

Brian DiDonato: Ralph, Brian, do you want to add anything? Yeah, the only thing I'd add, Eric, is that we're really pleased that, given the survival benefit of ChemTrac, the duration of therapy continues to be extended. The mean duration of therapy is now, you know, over 11 months, approaching 12 months, maybe more, and as patients stay on longer, and the tail is pronounced, as we see in the three-year survival follow-up, it's still unclear how long the duration of therapy can extend. So that's one of the upside potentials of ChemTrac. And as Ralph said, you know, 73% of net sales are coming from the United States. We'd expect that to continue going forward.

Speaker Change: Thank you, Jack and Mohammed. Thanks for the question, Jack. So, you're absolutely right, we're quite excited about the progress we're making with the early stage pipeline. So, for PWill following submission, we're now in the stage of activating sites.

Speaker Change: and then hopefully we'll be able to meet our target of enrolling the first station before the end of the year with h we've made the submission so it's we're waiting for health authority feedback and with a twenty-four we remain on track

Unknown Executive: We're quite excited about the progress we're making with the early stage pipeline. So for PWill, following submission, we're now in the stage of activating sites, and then hopefully, we'll be able to meet our target of enrolling the first station before the end of the year. With HLE, we've made the submission, so we're waiting for health authority feedback. And with A24, we remain on track to make the health authority submissions by the end of the year.

Unknown Executive: In terms of data, I mean, these are the first human trials, right? So we need to get the trials open and start accruing data. I'm sorry, it's too early to guide when we would expect data from these trials.

Michael Yee: Is the study all blinded? What are you seeing there? And what gives you that confidence to the real more patients? Thank you. Thank you, Michael. Ryan or Ralph, for the first question, David, for the HIV, please. Great. Ralph, wanted to take a key European question. Sounds good. Thank you. Thank you, Michael, for the question. So look, we've had successes with great investment as proven by the nine launches that we've had so far in this first half of the year.

Speaker Change: for making the health thirty submissions by the end of the year in terms of data i mean this is these are first humanment trials right so we need to get the trials open start aaccuruing 'm it's too early to guide to when we would expect data from these trumps

Mohammed Dar: So we need to get the trials open and start accruing. I'm sorry, it's too early to guide to when we would expect data from these trials. Okay.

Brian Donato: If I could just add one other point from Jack, it is that Mohammed's team has really baked in important learnings that we've made from our entire platform, from Kim track and from Fernetta. So the P will study is now designed in colorful cancer with all the best knowledge we have about where the platforms are going to work. Likewise, with the frame half light extension, which is essentially the same molecule as Fernetta, but within FC half light extended. All of the wall of data we're building in terms of combinations and translational insights are directly applicable to the frame half light extension.

Speaker Change: If I could just add one other point, Jack, is...

Mohammed: Mohammed's team has

Speaker Change: Really, fake pen.

Speaker Change: Important learnings that we've made from our entire platform, from ChemTrack and from Vernetafest. So the P-WOL study is now designed in coloreplicancer with all the best knowledge we have about where this platform is going to work.

Michael Yee: We increased the estimated reserve by 6.7 million, sorry. This should be a one-time thing based on the latest assumptions that we have on the negotiations. Now, in terms of looking forward, I would caution you against just adding the 6.7 because the erosion is both backward looking and forward looking and it's mainly on our negotiations with trans and Germany. Thank you, Michael. So with the HIV program, we're in the dose escalation phase of the multiple ascending dose.

Unknown Executive: Likewise, with the PREIM half-life extension, which is essentially the same molecule as brinidopus but with an FC half-life extended, all of the wall of data we're building in terms of combinations and translational insights are directly applicable to the PREIM half-life extension. So we see acceleration in our phase one trials based on these learnings.

Speaker Change: Likewise, with the PREM half-life extension, which is essentially the same molecule as brennetaphos, but with an FC half-life extended, all of the wall of data we're building in terms of combinations and translational insights are directly applicable to the PREM half-life extension. So we see acceleration in our phase one trials based on these learnings.

Brian Donato: So we see acceleration in our phase one trials based on these learnings. Thanks.

Operator: Got it. Thank you. Thank you. Our next question comes from the line of Justin Zelin with BTIG.

Justin Zelin: Thank you. Our next question comes from the line of Justin Zelin with BTIG. Please proceed with your question. Thanks for taking the question, and congrats on the progress. I think I'll ask a question about the autoimmune disease programs that looks like you're kicking off CMC manufacturing care for candidates. Any thoughts on a timeline for entering the clinic? These programs? Yeah, I think you're just in, you know, we're hoping by next year. So the CMC is going well, and you know, we take it from there. But yeah, we're excited about that program as well. Great. Thanks for taking my question.

Michael Schmidt: Hey guys, thanks for taking my questions. I have another one for David just on the PRAME program again.

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

Speaker Change: Thank you.

Michael Yee: And you know, as mentioned, we've gotten up to 300 micrograms and we'll continue to dose higher. There's a couple of important firsts that we're looking at. This is the first time we've taken our platform into a setting with such a low peptide target density and where we have such a low, in fact, you know, cell target density. And so it was an important question for us to ask, can we actually see anything?

Speaker Change: Thank you. Our next question comes from the line of Justin Zelen with BTIG. Please proceed with your question.

David Berman: Could you just provide us with your updated views on the opportunity in the lung cancer indication? Are there any particular patient groups and focus for the development strategy? Are you enriching certain patients into this cohort? Any particular genotypes perhaps that might benefit most from PRAME in lung cancer? And what should expectations be for the scope of that data readout later this year?

Justin Zelin: Thanks for taking the question.

Justin Zelen: Thanks for taking the question and congrats on the progress. I think I'll ask a question about the autoimmune disease programs. It looks like you're kicking off CMC manufacturing here for candidates. Any thoughts on a timeline for entering the clinic on these programs?

Unknown Executive: Thank you, Justin. You know, we're hoping by next year. So the CMC is going well. And, you know, we take it from there. But yeah, we're excited about that program as well.

Speaker Change: Thank you, Justin. You know, we're hoping by next year. So the CMC is going well and, you know, we take it from there. But yeah, we're excited about that program as well.

Michael Yee: And then, of course, there's never been a functional care, there's never been a therapy that can reduce the reservoir or delay the rebound. So these are all really important firsts, and we do see evidence of biological activity during the MAD portion, but it's still early, and there are only a few patients per court, and so we think it's prudent to get some more patients in that court and also to continue to go higher.

Justin Zelin: Thank you.

David Berman: Thanks so much.

Operator: Thank you. Our next question comes from the line of Jonathan Chang with Lyrinc Securities. Please proceed with your question.

Speaker Change: Great, thanks for taking my question.

Avantika Joshi: Our next question comes from the line of Jonathan Chang with Leering Securities. Please proceed with your question. Hi, guys. Thanks for taking my questions. First question.

Speaker Change: thank you our next question com from the line of jonathan chan with learerring securities please receive with your question

Brian Donato: We will discuss more of what biological activity means as we approach the full data release, which will be in the first quarter of next year. Thank you.

Avantika Joshi: How do you see the UVO melanoma competitive landscape potentially evolving in the future? What gives you confidence and the ability to continue and potentially expand the successful commercial story in the event of potential new entrants? And second question.

Jonathan Chan: Hi guys, thanks for taking my questions.

Speaker Change: First question, how do you see the uveal melanoma competitive landscape potentially evolving in the future? What gives you confidence in the ability to continue and potentially expand the successful commercial story in the event of potential new entrants?

Jessica Fye: Our next question is coming along with Jessica Fye with JP Morgan. Please proceed with your questions. This is Nick on for Jess. Thanks for taking your questions. First, on the Brenney Overeign Update, we should expect a nice moment. Can you just help set the stage for how many patients work a day and we should expect kind of split between mono and combo, though I believe you stated should be more combo. And maybe add to our detail around what you see is promising data that supports continued evaluation here in the setting based on some of those benchmark you provided.

David Bourbon: I guess just out of curiosity for the lower tech people like myself to provide more color on the AI enabled patient finder. And then how is this facilitating commercial story? Thank you. Great. Thank you so much for the great question. So start with David and maybe then evolve so you can comment more. Yeah, Jonathan, in terms of the landscape, I think there are two ways to look at efforts in the metastatic settings. We are in the HLA A2 positive. Of course, we now have the three-year survival benefit. It's a global standard of care. And so we're continuing to build on that.

Speaker Change: And second question.

Speaker Change: i guess just had a curiosity for the lower tech people like myself can provide more color on the ai enabled patient finder and how is es facilitating commercial story thank you

David Berman: Yeah, yeah, thanks, Michael. So with lung cancer, of course, you know, it's a lot more heterogeneous disease on multiple levels than ovarian and melanoma. And so we have been very interested in looking at those key subsets in order to first see the initial signal before we expand. So, you know, one example of the key subset, of course, are our actionable gene mutation positive patients because those are insensitive to checkpoints. And so that would make an interesting place for us to look. But there are other potential subsets as well.

Speaker Change: Great. Thank you so much for the great questions. So I'll start with David and maybe then Naval so you can comment more.

David Berman: We initially for monotherapy, as I talked about in the presentation, we focused on enrolling pre- and positive patients because about half of the adenocarcinoma patients are pre- and negative; half are positive. And for the initial signal, of course, we want to make sure that the patients are pre- and positive. And so we have been doing this double screening, looking for the right patients. And so the monotherapy data later this year will probably be smaller than what we're seeing for ovarian and for melanoma, but it's a little too soon to guide to the numbers for that.

David Berman: Yeah, Jonathan, in terms of the landscape, I think there are two ways to look at it. First, in the metastatic setting, we, in the HLA-A2 positive, of course, we now have the three-year survival benefit, it's a global standard of care.

Jessica Fye: Yeah, happy to say in terms of size, it's going to be roughly the same number as the continuous melanoma data set at ASCO. It will be mostly monotherapy, but in contrast to the ASCO melanoma, we will have more combinations because there's more chemotherapy options to catch here. So we'll be mostly mono with combination as well. In terms of the questions that we're going to be asking. So number one is I'm using the standard questions.

David Bourbon: We know that in the HLA two negative, there are studies going on. By the way, it's great to see options that those with that registration study is in the HLA A2 negative setting in terms of the adjuvant. We have the Atom trial, which is a well-designed standard. Relapse-free survival end point is the standard endpoint used globally for full approval. So this is a trial that we believe will give us a full approval label with high confidence in the adjuvant setting.

Speaker Change: and so we're continuing to build on that we know that in the ha two negative there are there areright

Speaker Change: Studies going on, and by the way, it's great to see options, but that registrational study is in the HLA-A2 negative setting. In terms of the adjuvant, we have the ADaM trial, which is a well-designed, standard

David Berman: Relapse-Free Survival Endpoint. It's the standard endpoint used globally for full approval, so this is a trial that we believe will give us a full approval label with high confidence in the adjuvant setting. We are aware that there is competition in the neoadjuvant setting, and I think it's too early for us to comment in terms of that. Ralph, do you want to talk about the AI? Thank you, David.

Jessica Fye: You know, I've been asking throughout my drug development career in the stage. Is there monetary activity? Can you combine with the intended registration of partner if you plan to do a combination and can you have confidence that the drug activity can meet whatever. So those are the types of questions we're asking in order to progress in terms of the metrics or the benchmarks, I think you were asking. Yes, so there aren't a lot of good benchmarks in this heavily retreated platinum resistance setting or a few published chemotherapy trials. And so the chemotherapy benchmarks there, the response rates are in the single digits and the disease control rates about 40 to 50%.

David Berman: well

Speaker Change: VLAPS Free Survival Endpoint. It's the standard endpoint used globally for full approval.

Speaker Change: So, this is a trial that we believe will give us a full approval label with high confidence in the adjuvant setting. We are aware that there's competition in the neoadjuvant setting, and I think it's too early for us to comment in terms of that. Ralph, do you want to talk about the AI?

Ralph Torbay: We are aware that there's competition in the neo adjuvant setting, and I think it's too early for us to comment in terms of that. Well, if you want to talk about the AI. Thank you, David. So we're very excited about this tool, actually, because when you recall, we're discussing initially how our approach to addressing the market, particularly in the US. We talked about the fact that there's a higher density at academic accounts, and then after that it tells off with very low density in the community. And one of the challenges is how do you address that low density, those patients that pop off once a year or once every other year.

Operator: Thank you, David. So we're very excited about this tool, actually, because when you recall, we were initially discussing our approach. Thank you. Our next question comes from the line of Peter Lawson with Spark Place. Please proceed with your question.

Ralph: Thank you, David. So we're very excited about this tool, actually, because when you recall, we were discussing initially how our approach

Ralph: to addressing the market, particularly in the US.

Speaker Change: we talked about the fact that there's a higher density at acadeemic accounts and then after that it tails off with very low density in the community

David Berman: Great. And then in addition to evaluating, bringing the platinum resistance in varying cancer patients, you noted some evaluation, the platinum sensitive setting as well. So you can try a little more detail, the progress there and when we kind of expect an update from that they've said. So how do you want to take that? Sure. Kind of happy to do that. So as David mentioned, obviously, you know, varying is more, you know, more heterogeneous and complex than melanoma.

Ralph: And one of the challenges is, how do you address that low density, those patients that pop up, you know, once a year or once every other year?

Ralph Torbay: And really now that AI has gotten to the place where some of the predictive models have become very good. We're leveraging that ability to predict based on historical data where the patients and when the patients might pop in, in some of the different practices. And that's enabled us to find patients and 10 reps on a just-in-time basis, which allowed us to basically keep our rep footprint. The same. Understood. Thank you.

Speaker Change: and really now that ai has gotten to the place where some of the predictive models have become very good

Speaker Change: we're leveraging that ability to predict based on on historical data where the patients and when the patients might pop in in some of the different practices and that's enable us to find patients and ten beps on justin time basis which allowed it to basically keep our footprint the same

David Berman: So we've been exploring mostly in the platinum resistance setting, but now the study does allow us to move to earlier lines and combine with the therapies that are used in sensitive and those include that. And then also will include platinum, double it. Great. Thank you.

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

Peter Lawson: Our next question comes from the line of Peter Lawson with Spark Place. Please proceed with your question. Hey, good morning.

Speaker Change: understood

Peter Lawson: thank you our next question comes from the line of peter lawson with spark place please proceed with your question

Peter Lawson: This is Alex on repeat. Thank you for taking our questions. Just had two on the ovarian update. So assuming data is supportive.

Peter Lawson: hey good morning this is alex on repeter thank you for taking our questions just had two on on the oarian update

David Bourbon: Would you pursue a monotherapy or chemo combination approval in the platinum resistance setting, or would the goal be to maybe try to go sort of directly into earlier lines of therapy and in combination with chemo? Thank you, Alex. David. Yeah, so Alex, I guess it's important to understand, you know, to remind about our what insights we've made. First of all, our platform works really well with disease control. It works. Very well, you know, it increased activity in earlier lines. And we think it works best in combinations in a varying cancer. Which is different from titanium.

Alex: so assuming data supportive would you pursue a am monnootherapy or chemo combination approval and in the platinum resistance setting or would the goal be to maybe try to go sort of directly into earlier lines of therapy and and combination with chemo

David Berman: The combinations, of course, are where we're also interested because that's where we believe our platform is going to work best in terms of combinations. So it will be a monotherapy, and it will be mostly a chemotherapy combination initially. As I talked about, Michael, going into next year, we expect to move into earlier lines with the DOSI-Taxel combination and with the RC-Martinet combination. Mohamed, anything you want to add? No, I guess we all...

Tyler Van Buren: And then the second question is if you can combine with non platinum chemo with good safety, do you believe that the likelihood of combining with platinum chemo in the front line with platinum sensitive patients is high?

David Berman: Thank you, Alex, David.

Speaker Change: Yeah, so, um, Alex, I guess it's important to understand, you know, to remind about our, what insights we've made. First of all, our platform works really well with disease control. It works very well, you know, it increases activity in earlier lines.

Mohammed Dar: No, I guess we will also have chemo, platinum-based chemotherapy options. That will come a little bit later after OC and dosing.

Speaker Change: and we think it works best in combinations

David Berman: Yeah, so I'll address the first one and then, Mohammed, you can talk about that. So Tyler, the Merva, it's good to see that there's a new medicine for these patients and it's, you know, not you know, this Merva is a targeted chemotherapy, we know that chemotherapy is the work there. So the key differences, I would say Tyler for us is that the Merva strategy is in the p-rock setting, it's for place chemotherapy.

David Bourbon: There's these two major disease segments, and of course multiple different combinations. So we have to generate the data before we decide on what the next step is. So the immediate next steps are more chemotherapy combinations in the platinum resistance setting. And then, as we talked about more platinum combinations and the system at combination in the platinum sensitive. This is the data set that we think will enable us to make the best decision on what the next study is.

Alex: in a very cancer which is different from continainuous there's these two major disease segments and of course multiple different combinations

Unknown Executive: So we have to generate data before we decide on what the next step is. So the immediate next steps are more chemotherapy combinations in the platinum-resistant setting. And then, as we talked about, more platinum combinations and a systematic combination in the platinum sensitive. This is the data set that we think will enable us to make the best decision on what the next study is, P-ROC or P-SUT. Okay, great. And do we actually see any BEV combination patients in the 3Q update?

Operator: You have cut off. If you could repeat your first question, please?

Operator: so we have to generate the data before we decide on what the next step is so the immediate next steps are

Operator: More.

Alex: chemotherapy combinations in the platinumnumber resisting setting and then as we talked about a more com at platinum combinations and ever so the that combination in the plas ten that it this is the data set that we think will enable us to make the best decision on what the next study is pe rock or pizza

David Berman: Our strategy is to add on chemotherapy, not to replace chemotherapy. And so our approach is going to be an add-on to chemotherapy. And of course, eventually, it also could be an add-on to Merva Tech's Merva as well.

David Bourbon: P rock or pizza. Okay, great.

David Bourbon: And do we actually see any best combination patients in the three key updates? No, there won't be any balances in our combinations in this update. Okay, thank you. Thank you.

Speaker Change: Okay, great. And do we actually see any BEV combination patients in the 3Q update?

Mohammed Dar: And do you want to comment on the sensitivity? Sure, happy to do that. So I would say, Tyler, you know, this is early days, this is the first time we're actually combining our platform with chemotherapy and we're learning, but so far, you know, the expectations that we should be able to combine and the plan is to then move from the non-platinum-based chemotherapies to the platinum-based chemotherapies over the coming months and into next year. Thank you.

Speaker Change: No, there won't be any Babicism abominations in this update.

Jack Allen: Great, thank you. Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question. Alright, thanks so much for taking the question and congratulations on the progress.

Speaker Change: Okay, thank you.

Ahu Demir: Our next question comes from the line of Who Demir with Latinburg thumb in. Please proceed with your questions. Good morning. Thank you for taking my questions. Two questions from us. First one is on the lung cancer program. Then you present data. Disclose data format. You cut off. If you could repeat your first question, please.

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

Speaker Change: thank you our next question comes from the line of a whode deimmior with lanamburg thomman please ceed with your questions

Jack Allen: Thanks for the question, Jack. You're absolutely right.

Jack Allen: Great. Thank you, Jack and Mohammed.

Mohammed Dar: We're quite excited about the progress we're making with the early stage pipeline. So for PWill, following submission, we're now in the stage of activating sites, and then hopefully, we'll be able to meet our target of enrolling the first patient before the end of the year. With HLE, we've made the submission, so we're waiting for health authority feedback. And with A24, we remain on track to make the health authority submissions by the end of the year.

whode deimmior: Good morning, thank you for taking my questions. Two questions from us, first one is on the lung cancer program. When you present data

Speaker Change: disclose data format

Eric Schmidt: Our next question comes from the line of Eric Schmidt with Cantor Fitzgeralds, please proceed with your question. Well, thanks for taking my question. Maybe back to KimTrack for a moment. It sounds like you've crossed the $300 million annualized run rate for the first time you've grown now for several quarters of 30% or more year on year. You've spoken of more patients out there than you thought previously and longer duration, of course, than you would assume.

Mohammed Dar: In terms of data, I mean, these are the first human trials, right? So we need to get the trials open and start accruing data. I'm sorry, it's too early to guide when we would expect data from these trials. If I could just add one other point.

Speaker Change: and i actually knew if

Mohammed Dar: I was asking how many patients' disclosure that you would have from the lung cancer and what percentage would have monetary versus combination? And I have another question. Thank you.

Operator: And I have another one. OK, thank you.

Eric Schmidt: So I guess the question is, what's the ceiling for this drug in the car? You feel no longer in vacation? Do you think it's a 500, 600, 700 million drug? Where's this going to end? Thank you, Eric. Well, if you want to take that and maybe blind, you can comment also at the end. Happy to. Thank you, Eric, for the question. So look, we're very proud of the growth that we've had. A lot of it has been driven as we've stated by the U.S, growth where we're 65% penetrated.

Mohammed Dar: If I could just add one other point, Jack, Mohammed's team has really baked in important learnings that we've made from our entire platform, from ChemTrack and from Vernetafest. So the P-Wall study is now designed in coloreplicance with all the best knowledge we have about where this platform is going to work. Likewise, with the PREIM half-life extension, which is essentially the same molecule as bronotophos but with an FC half-life extended, all of the wall of data we're building in terms of combinations and translational insights are directly applicable to the PREIM half-life extension. So we see acceleration in our phase one trials based on these learnings. Got it, thank you. Thank you. Our next question comes from the line of Justin Zelin with BTIG.

Mohammed Dar: I would say it's too early to say, but I'll give it to Mohammed to tell you. Sure, thanks. Thanks for the. Thanks for the question. In terms of lung cancer, as you know, David mentioned, it is obviously a more. It's a more heterogeneous setting compared to melanoma, and we are still in the initial signal detection mode. But in terms of patients, it will be likely a smaller data set than melanoma and ovarian. And we will likely have more combo patients than mono patients for the reason David mentioned that, for monetarily, we have to select for premium with combo.

Speaker Change: In terms of patients it will be likely a smaller dataset than melanoma and ovarian and we will likely have more combo patients than mono patients, but the reason David mentioned that for monotherapy, we have to select for frame and with combo, we are aligning regardless Supreme status.

Eric Schmidt: It's important to keep in mind to aspect one is the reimbursement landscape in Europe is such and the challenges are such that we expect really minor to very incremental growth coming from Europe moving forward. So a lot of the growth will be driven by the U.S., a lot of the incremental growth will be driven by the U.S. That's for MUM. But really, I think where we get very much excited is when we think about the label expansions that are possible with the TABIAM study, which is expect, which expects data in 2026, as I mentioned.

Mohammed Dar: We are lying regardless of print steps. Mohammed, that's helpful.

Operator: Okay.

Speaker Change: Okay. That's helpful. My second question is on the HIV program.

David Bourbon: My second question is on the HIV program. You touched on the viral load and also the rebounds, right? Would give you confidence to move forward from the meds, would you be looking for, what data would you be looking and train to combinations for that program? Yeah, David. Yeah, it's a really good question, Ahu, because of course we're pioneering this area here. No one's generated the data thresholds for what, you know, what's the price move forward. I would say at this stage, any evidence of activity that is definitely related to, you know, antiviral would be really intriguing to us because no one's been able to show that.

Speaker Change: You touched on the viral load and also the re bonds right.

Unknown Executive: Transcripts provided by Transcription Outsourcing, LLC, and many more combinations like that.

Speaker Change: I would give you confidence to move forward from the mats.

Speaker Change: Would you be looking for what that how would you be looking.

Eric Schmidt: And from the atom study a little bit further down the line, that also would bring us into the adjuvant setting, bring the platform to the adjuvant setting. So I think there is still significant growth for Kim Tribe, up to 6,000 patients, potentially benefiting from it. Well, the only thing I'd add to Eric is that we're really pleased that given the survival benefit of Kim Track, that the duration of therapy continues to extend.

Speaker Change: I mean, it's.

Speaker Change: So combinations for that program.

Unknown Executive: Yeah, it's a really good question because, you know, we're pioneering this area here. No one has generated the data thresholds for what, you know, what's required to move forward.

Unknown Executive: Yeah, David Yes, it's a really good question I hope because of course, you know we're pioneering the site.

Speaker Change: Her no one's generated the data thresholds for what.

Eric Schmidt: The mean duration of therapy is now, you know, over 11 months, approaching 12 months, maybe plus, and as patients stay on longer and the tail is pronounced as we see in the three-year survival follow-up, it's still unclear how long the duration of therapy can extend. So that's one of the upside potentials in Kim Track. And as Ralph said, 73% of net sales are coming from the United States. We'd expect that to continue going forward. Thank you.

Unknown Executive: You know what sort of price move forward I would say at this stage any evidence of activity that is definitely related to anti viral would.

Speaker Change: It would be really intriguing to us because no one's been able to show that so we're looking at can you reduce the viral reservoir and can you delay or also the rebound kinetics anything I think here would be interesting for us to continue of course at the end of the day, it's going to have to be an anti viral.

David Bourbon: So we're looking at, can you reduce the viral reservoir and can you delay or alter the rebound kinetics? Anything I think here would be interesting for us to continue. Of course, at the end of the day, it's going to have to be an antiviral delay and rebound that is going to be the end point. But I think any insights we make here are going to be important for us. So immediate next steps are for us to generate more data and to get to higher doses because we only have a few patients per cohort. Yeah, and I would just, one thing, I think you talked about the combination just reminds you that to do it, the first part is on top of the antiviral survival.

Unknown Executive: I would say at this stage, any evidence of activity that is definitely related to, you know, antiviral activity would be really intriguing to us, because no one's been able to show that. So we're looking at, can you reduce the viral reservoir? And can you delay or alter the rebound kinetics?

Unknown Executive: Delay in rebound that it's going to be the endpoint, but I think any insights. We make here are going to be important for us. So immediate next steps are for us to generate more data and to get to higher doses, because we only have a few patients per cohort.

Michael Schmidt: Our next question comes from the line of Michael Schmidt with Duganheim. Please proceed with your question. Hey guys, thanks for taking my question.

Unknown Executive: Anything I think here would be interesting for us to continue. Of course, at the end of the day, it's going to have to be antiviral delay and rebound that is going to be the endpoint. But I think any insights we make here are going to be important for us. So the immediate next steps are for us to generate more data and to get to higher doses, because we only have a few patients per cohort. Yeah, and I would just add one thing.

Unknown Executive: And I would just add.

Unknown Executive: One thing I think you talked about the combination just to remind you that we do it. The first part is on top of the anti retroviral.

Michael Schmidt: I have another one for David, just on the praying program again. Could you just provide us with the updated views on the opportunity in the lung cancer indication? Are there any particular patient substance and focus for the device? The government strategy? Are you enriching certain patients into this cohort? Any particular genotypes perhaps that might benefit most from praying in lung cancer? And what should expectations be for the scope of that data read out later this year?

Unknown Executive: Yeah.

Unknown Executive: Thank you so much. Thank you.

Mitch: Thanks Mitch.

Avantika Joshi: Thank you.

Justin Zelin: Thank you. Our next question comes from the line of Justin Zelin with BTIG. Please proceed with your question. Thanks for taking the question.

<unk> Joshi: Thank you. Our next question comes from the line of <unk> Joshi with Mizuho. Please proceed with your question.

Avantika Joshi: Our next question comes from the line of Haventika, Joshi, with Mizzouha. Please proceed with your question.

Justin Zelin: Thank you, Justin. You know, we're hoping by next year. So the CMC is going well. And, you know, we take it from there. But yeah, we're excited about that program as well.

Justin Zelin: Thank you. Our next question comes from the line of Jonathan Chang with Lyrinc Securities. Please proceed with your question.

Avantika Joshi: Hi, this is Avantika on for Greg. I just had a question: are you still looking up for none of us in tumors beyond melanoma, ovarian, and non-small cell? Yeah, you know, we certainly are in this strong scientific rationale, but as at the team, I've asked them to focus, right?

Jonathan Chang: Hi guys, thanks for taking my questions. First question, how do you see the uveal melanoma competitive landscape potentially evolving in the future? What gives you confidence in the ability to continue and potentially expand the successful commercial story in the event of potential new entrants? And second question, I guess just out of curiosity for the lower tech people like myself, can you provide more color on the AI-enabled patient finder and how is this facilitating the commercial story? Thank you.

Unknown Executive: Hi, This is of Armstrong for Greg.

Speaker Change: I just had a question are you still looking up for manifest in tumors beyond melanoma ovarian and non small cell.

Jonathan Chang: Great, thank you so much for the great questions. So I'll start with David and maybe then Naval, so you can comment more.

Unknown Executive: Yeah.

Speaker Change: We certainly are and there's a strong scientific rationale but as at.

David Berman: Yeah, Jonathan, in terms of the landscape, I think there are two ways to look at it. First, in the metastatic settings, we, in the HLA-A2 positive, of course, we now have the three-year survival benefit. It's a global standard of care. And so we're continuing to build on that.

Unknown Executive: On the team, I've asked them to focus, right? We're launching a global phase three cutaneous melanoma. We are committed to following up on the signals in ovarian cancer and looking for signals in lung cancer, and we've certainly had the sites focus on those as well. We do have ongoing phase one exploration in other tumors, but we've had to focus. And so we are certainly interested in and will continue to be interested in other tumors like endometrial.

Speaker Change: But the team I've asked them to focus strike, we're launching a global phase III cutaneous melanoma, we are committed to following up on the signals in ovarian and to look for signals in line and we certainly have the sites focused on those as well we do have ongoing phase one exploration in other tumors, but we've had some focus.

David Berman: We know that in the HLA-A2 negative setting, there are studies going on. And by the way, it's great to see options, but that registrational study is in the HLA-A2 positive setting. In terms of the adjuvant, we have the ADAM trial, which is a well-designed standard Relapse Free Survival Endpoint. It's the standard endpoint used globally for full approval. So this is a trial that we believe will give us a full approval label with high confidence in the adjuvant setting. We are aware that there is competition in the neoadjuvant setting, and I think it's too early for us to comment in terms of that. Ralph, do you want to talk about the AI? Thank you, David.

David Bourbon: We're launching a global Phase 3, ketine is melanoma. We are committed to following up on the signals in ovarian and to look for signals in line, and we've certainly had the sites focus on those as well. We do have ongoing phase 1 exploration in other tumors, but we've had to focus, and so we are certainly interested and continue to be interested in other tumors like endometrial.

Michael Schmidt: Thanks so much. Yeah, thanks Michael. So with lying, of course, you know, it's a lot more heterogeneous disease on multiple levels and are very in and melanoma. And so we have been very interested in looking at those key subsets in order to first see the initial signal before we expand. So, you know, one example of the key subset, of course, are our actionable gene mutation positive patients because those are in sense that the checkpoints.

Ralph Torbay: Thank you, David. So we're very excited about this tool, actually, because when you recall, we were initially discussing how our approach to addressing the market, particularly in the U.S. We talked about the fact that there's a higher density at academic accounts, and then after that, it tails off with very low density in the community. And one of the challenges is, how do you address that low density, those patients that pop up once a year or once every other year?

Ralph Torbay: And really, now that AI has gotten to the place where some of the predictive models have become very good, we're leveraging that ability to predict based on historical data and when patients might pop in at some of the different practices. And that's enabled us to find patients and send reps on a just-in-time basis, which allows us to basically keep our rep footprint.

Unknown Executive: And so we are certainly interested in continued to be interested in other tumors like endometrial.

Mohammed Dar: And one more question was for the earlier stage assets for P115C and P119C: are you initially running basket studies, or are you focusing on specific tumors? Thank you.

Speaker Change: And one more question was for the earlier stage assets for a key one month I see in Q1 were 90 are you initially running basket studies are you focusing on specific tumor.

Michael Schmidt: So that would make an interesting place for us to look, but there are other potential subsets as well. We have initially for the monotherapy as I talked about in the presentation, we focused on enrolling praying positive because about half of the ad note. I don't know, I don't know. Of course, no patients are praying negative, half are positive and fully initial signals. Of course, we want to make sure that the patients are praying positive.

Unknown Executive: Yeah.

Speaker Change: Hey go ahead, what kind of day.

Mohammed Dar: I have to admit that I'm not; I don't want to retain the members, but are those numbers referring to the half-life extended in the 824? Yeah, the half-life extended in the 824. We would have to simplify them. Yeah, I'm sorry about that. As David mentioned earlier, we are certainly applying all the learnings from our F1F6E training program to those two programs. We know where a training is expressed, so yeah, those trials are diversibly, so we have multiple options in terms of the types of patients that can enroll. Okay, thank you.

Speaker Change: I have to admit that I'm not.

Unknown Executive: I want to retain the members but go ahead.

Speaker Change: Are those numbers, referring to the half life extended into a 20 year half life extended and the the.

Michael Schmidt: And so we've had been doing this double screening looking for the right patient. And so the monotherapy data later this year will be a smaller, probably than what we're seeing for a variant and for melanoma, but it's a little too soon to guide to the numbers of that. The combinations, of course, is where we're all so interested because that's where we believe our platform is going to work best in terms of combination.

Unknown Executive: The 824.

Unknown Executive: We would have to simplify them,

Speaker Change: It would have to simplify it.

Unknown Executive: As David mentioned earlier, we are certainly applying all of the learnings from our F-106-C PRANE program to those two programs. We know where PRANE is expressed.

Unknown Executive: Yeah I'm sorry.

Unknown Executive: Got it.

Unknown Executive: As David mentioned earlier, we are certainly applying all the learnings from our F. One and succeed.

Unknown Executive: So, yes, those trials are designed flexibly, so we have multiple options in terms of the types of patients that we can enroll. Okay, thank you. Thank you. Our next question comes from the line of Jeffrey Hung with Morgan Stanley.

Speaker Change: Training program to those those two programs we know we're praying as expressed so yes. Those trials are simply said we have multiple options in terms of the types of patients have been enrolled.

Michael Schmidt: So it will be a monotherapy and it will be a mostly chemotherapy combination initially. As I talked about, Michael, going into next year or weeks, expect to move into earlier lines with the dosy taxable combination and with the ocean marks and that combination. Mohammed, anything you want to add? No, I guess we also have chemo platinum based chemotherapy options that will come a little bit later after OC and dosy. Thank you.

Speaker Change: Okay. Thank you.

Jeff Hung: Thank you.

Ralph Torbay: Thank you. Our next question comes from the line of Peter Lawson with Spark Place. Please proceed with your question.

Alex Andre: Thank you for taking our questions. We just had two on the ovarian update. So, assuming data is supportive, would you pursue a monotherapy or chemo combination approval in the platinum resistance setting? Or would the goal be to maybe try to go sort of directly into earlier lines of therapy and combinations of chemo?

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

David Bourbon: Our next question comes from the line of Jeffrey Hung, with Morgan Stanley. Please proceed with your question. Hello, this is Selena on for Jeff. There are two questions here on frame for the melanoma data. CT DNA responders were defined as 0.5 log reduction. Do you expect that threshold for meaningful correlation to longer survival to be similar across indications like an ovarian in line? And the second question from us, when might we expect an update from the endometrial cohort? Thank you.

Alex Andre: Thank you, Alex. David?

David Berman: Yeah, so, Alex, I guess it's important to remind you about our, what insights we've made. First of all, our platform works really well for disease control. It works very well, you know, it increases activity in earlier lines, and we think it works best in combinations. In ovarian cancer, which is different from cutaneous cancer, there are these two major disease segments and, of course, multiple different combinations.

Peter Lawson: Hey, good morning. This is Alex Andre Peter.

Karina: Hello, This is karina on for Jeff.

Speaker Change: Two questions here on the screen.

Speaker Change: The melanoma data P. T DNA responders were defined as quint five log reduction.

Speaker Change: The threshold for meaningful correlation to longer survival to be similar across indications.

Jack Allen: Our next question comes from the line of Jack Allen with Baird. Please proceed with your question. Thanks a lot for taking the question and congratulations on the progress. I wanted to ask a little bit about the earlier stage pipeline. I know the pill will program recently cleared CTA and is expected to enter the clinic in the second half of this year. And you also submitted the CTA for the half life extended frame and have plans to submit the CTA for the frame A24 program.

Unknown Executive: In ovarian and lung.

Speaker Change: And the second question.

Unknown Executive: We expect an update from the endometrial cohort.

Unknown Executive: Yeah, I'm happy to take both of those. But, you know, ctDNA response criteria are still in their early stages. Externally, companies have looked at lung cancer, for example, at a 0.5 log reduction. So there's precedent for that, called the molecular response. In our cutaneous melanoma data, that 0.5 log reduction did seem to, sorry, in our uveal melanoma data, that 0.5 log reduction did seem to be a good threshold cutoff for correlating with survival.

Speaker Change: Thank you, yes, I'm happy I'm happy to take both of those so you know C. T. DNA response criteria are still in their early stages externally.

David Bourbon: Yeah, I'm happy, yeah, I'm happy to take both of those. So, you know, ct DNA response criteria are still in their early stages. Externally, companies have looked in line cancer, for example, at a 0.5 log reduction. So, there's precedence of that called a molecular response. In our continuous melanoma data, that 0.5 log reduction did seem to, sorry, naïve melanoma data, that 0.5 log reduction did seem to be a good threshold cutoff for correlating with survival. We saw the same correlation in continuous melanoma, and we'll share that data on ct DNA at as well. But it does look like that 0.5 log reduction. I think is a good log reduction.

Unknown Executive: Companies have looked in lung cancer for example at a <unk> five log reduction so this precedent for that called the molecular response.

Mohammed Dar: I guess my question here is, when can we start to see the pipeline kind of build out and see critical data from some of these earlier assets? Great. Thank you, Jack. Mohammed. Thanks for the question, Jack. So you're absolutely right. We're quite excited about the progress we're making with the early early stage pipeline. So for P will following submission. We're now in the stage of activating sites. And then hopefully we'll be able to meet our target of enrolling the first station before the end of the year with HLE.

Unknown Executive: In our cutaneous melanoma data at that 0.5 log reduction did seem to sorry, not uveal melanoma data at that 0.5 log reduction did seem to be a good threshold cutoff for correlating with survival. We saw the same correlation in cutaneous melanoma and we'll share that data.

Unknown Executive: We saw the same correlation in cutaneous melanoma, and we'll share that data on ctDNA and on the ovarian data at ESMO. But it does look like that 0.5 log reduction is a good log reduction, is a good threshold for us. Based on the data we have today, in terms of the endometrial timeline, I think it's a little too soon to guide because, as I mentioned, we've asked the team to focus on ovarian lying and cutaneous melanoma. We've asked the sites to focus on that as well.

Speaker Change: On C T D.

Unknown Executive: <unk>.

Unknown Executive: On the ovarian data at ESMO, but it does look like that 0.5 log reduction I think is a good log reduction is a good threshold for us personally.

David Bourbon: It is a good threshold for us based on the data we have today.

David Berman: So we have to generate the data before we decide on what the next step is. So the immediate next steps are more chemotherapy combinations in the platinum-resistant setting and, as we talked about, more platinum combinations and systematic combinations in the platinum-sensitive setting. This is the data set that we think will enable us to make the best decision on what the next study is, PROC or PSAP.

Mohammed Dar: We've made the submission. So it's, you know, we're waiting for health authority feedback. And with A24, we remain on track for making the health 30 submissions by the end of the year in terms of data. I mean, this is these are first in human trials, right? So we need to get the trials open and start accruing.

Unknown Executive: Based on the data we have today in terms of the endometrial timeline I think it's a little too soon to guide because as I mentioned, we've asked the team to focus on ovarian lung and cutaneous melanoma with asthma sites to focus on that as well.

David Bourbon: In terms of the endometrial timeline, I think it's a little too soon to guide because, as I mentioned, we've asked the team to focus on ovarian lying in ct DNA. No, no, no, we've asked the sites to focus on that as well. Thank you.

Unknown Executive: Okay.

Mohammed Dar: I'm sorry, it's too early to guide to when we would expect data from these trials.

David Berman: Okay, great. And do we actually see any BEV combination patients in the 3Q update?

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

Speaker Change: Thank you. Our next question comes from the line of Noreen kept Ria with capital One Securities. Please proceed with your question.

Noreen Kipria: Our next question comes from the line of Noreen Kipria with Capital One Securities. Please proceed with your question. Hi, good morning. I can rest on all the progress. I guess my first question sort of follows up on the last one. In terms of, you know, the premium results that you'll be presenting at ESMO, you know, you've observed benefit with KimTrack outside of recess response. Right. So can you remind us how you're tracking response rates under estimates? You know, should we just focus on the disease control rates or, you know, you mentioned that they'll be ct dna.

David Berman: If I could just add one other point from Jack is, Mohammed's team has really baked in important learnings that we've made from our entire platform from Kim track and from Burnettapest. So the P will study is now designed in colorful cancer with all the best knowledge we have about where the platforms are going to work. Likewise with the praying half light extension, which is essentially the same molecule as Burnettapest, but within Fc half light extended.

David Berman: No, there won't be any Babicism abominations in this update.

David Berman: Okay, thank you.

Naureen Quibria: Hi, good morning. Congratulations on all the progress. I guess my first question sort of follows up on the last one. It's in terms of, you know, the premium results that you'll be presenting at ESMO. You've observed benefits with ChemTrack outside of rhesus response, right? So can you remind us how you're tracking response rates under estimates? You know, should we just focus on the disease control rates, or, you know, you mentioned that there'll be ctDNA. Is there anything else?

Speaker Change: Hi, Good morning, Congrats on all the Congress and I guess my first question sort of follows up on that last one in terms of.

Speaker Change: The claim reserves that you're you'll be.

Speaker Change: Presenting it as no.

Speaker Change: Their benefit with contract outside of recessed response, right. So can you remind us how you're tracking them responsibly underestimates you know should we just focus on the disease control rate or <unk>.

David Berman: All of the wall of data we're building in terms of combinations and translational insights are directly applicable to the train path by extension. So we see acceleration in our phase one trials based on these learnings. Thank you.

Speaker Change: Mentioned that there'll be C T DNA damage.

David Bourbon: Is there anything else? Yeah, it's a good question. I mean, we certainly saw this with UVL melanoma. This eventations would take both radiographic increase in size that benefit the survival benefit but long-term survival. We saw a few patients of those with frenetifus in the cutaneous melanoma. We will, I think, continue to see that in Noreen and the line as well. I think the way that we're looking at how do you measure benefit, of course, is ct DNA, which is a way to measure independent of radiographic, but also looking at treatment beyond progression, because this is where the investigator sees the patient having a radiographic increase in size.

Speaker Change: Moving out.

Speaker Change: Yes, it's a good question I mean, we certainly saw this with Uveal melanoma.

Speaker Change: Even patients with.

Speaker Change: Radiographic increased in size that benefit that survival benefit line.

Justin Zelin: Our next question comes from the line of Justin Zelin with BTIG. Please proceed with your question. Thanks for taking the question and congrats on the progress.

Speaker Change: Term survival, we saw a few patients of those with Barnett a fast in the cutaneous melanoma, we will I think continue to see that in the ovarian and lung as well I think the way that we're looking at how do you measure benefit of course as C. P. DNA.

Unknown Attendee: I think I'll ask a question about the autoimmune disease programs that looks like you're kicking off CMC manufacturing care for candidates. Any thoughts on a timeline for entering the clinic these programs? I think you're just in you know we're hoping by next year so the CMC is going well and you know we take it from there but yeah we're excited about that program as well. Great thanks for taking my question. Thank you.

Speaker Change: Which is a way to measure independent of radiographic, but also looking at treatment beyond progression. Because this is where the investigator sees the patient payment, having a radiographic ink based on size, but they feel the patient is benefiting so if we saw this early this treatment beyond progression was and a good initial.

David Bourbon: But they feel the patient's benefiting. So if we saw this early, the treatment beyond progression was and a good initial indicator. Now, although we do see this TD benefits, we see very strikingly for KimTrack, we feel that with frenetifus disease control rates is an equally, is a very good metric to predict PFF. And in fact, my sense of the data is that although frenetifus does have benefit in the TD, it is more of a disease; it has more disease control than KimTrack did. But I think at the end of the day, of course, survival will be the ultimate endpoint.

Naureen Quibria: Uh huh.

Speaker Change: Now, although we do see this.

Speaker Change: T D benefit we see very striking lipa contract, we feel that with <unk> disease control rate is an equally it's a very good metric to predict PFS and in fact my sense of the data is that although <unk> does have benefit in the T. D. It is more of a disease that has more disease control.

Jonathan Chang: Our next question comes from the line of Jonathan Chang with Learing Securities. Please proceed with your question. Hi guys thanks for taking my questions.

David Berman: First question, how do you see the UVO melanoma competitive landscape potentially evolving in the future? What gives you confidence and the ability to continue and potentially expand the successful commercial story in the event of potential new entrants? And second question, I guess just out of curiosity for the lower tech people like myself to provide more color on the AI-enabled patient finder and then how is this facilitating commercial story? Thank you. Great thank you so much for the great question.

Speaker Change: Then contract it.

Speaker Change: But I think at the end of the day of course survival will be the ultimate endpoint I do feel PFS instill a good endpoint appropriate out of us having anything to add on that okay.

David Bourbon: I do feel PFF is still a good endpoint for Frenetifus.

David Bourbon: Muhammad, anything to add on that? Okay, that's helpful.

Naureen Quibria: Okay. That's helpful and I guess sort of sticking can be ovarian cancer.

Mohammed Dar: And I can sort of stick into the Avarian Cancer topic. You know, what's a distribution of praying compared to folate receptor? Is there like an overlapped there? I guess I'm just trying to gauge, you know, if you expect to see any patients coming off of state Eula hair, you know, into this. Would there be any of those types of patients in the combo? Sure, sure, Naureen, happy to address that. So for praying per se, it's very similar to, you know, very similar to melanoma; it's around, you know, 80 to 90 percent with the versus the folate receptor alpha for allahari, it's like, you know, between 35 and 40 percent.

Naureen Quibria: Topic.

Speaker Change: What's the distribution of clean comparator folate receptor is there like an overlap there I guess I'm just trying to gauge you know if you.

David Berman: So start with David and maybe then evolve so you can comment more. Yeah Jonathan in terms of the landscape I think there are two ways to look at it. First in the metastatic setting we in the HLA A2 positive of course we now have the three-year survival benefit. It's a global standard of care and so we're continuing to build on that. We know that in the HLA two-negative there are studies going on by the way it's great to see options that those that registration study is in the HLA A2 negative setting.

Speaker Change: Like to see any patients coming off of state. Your hair, you know into basketball would there be any of those types of patients in that comment.

Unknown Executive: Sure, sure, Naureen, happy to, happy to address that. So for PRAME per se, it's very similar to, in ovarian cancer, it's very similar to melanoma. It's around, you know, 80 to 90 percent. And with the rest of the folate receptor alpha, for LHR, it's like, you know, between 35 and 40 percent. The exact overlap, you know, I don't, I don't think we have that data, but, you know, there's probably some overlap, but you can derive sort of 30 to 40 percent for the folate receptor, and 80 to 90 percent is the prevalence for PRAME in ovary.

Speaker Change: Sure sure Nobody is happy to happy to address that so for frame per se, it's very similar to <unk>.

Speaker Change: It's very similar to melanoma, it's around 80% to 90% with the rest of the folate receptor alpha.

Unknown Executive: <unk> like between 35 and 40% the exact overlap.

Mohammed Dar: The exact overlap, I, you know, I don't, I don't think we have that data, but, you know, there's probably some overlap, but you can derive sort of 30 to 40 percent for folate receptor and 80 to 90 percent is the prevalence for praying in a variant. I'll just add that what we've seen, continually, we saw in melanoma, B-raft mutant, wild type in the, and with the EGFR, because we've looked at that mutation that it's in line, that we see praying expression independent of whether there's mutation or not. And so, although, as Muhammad said, we don't have the exact overlap with folate receptor alpha, I suspect 90 percent of folate receptor alpha positive are going to be positive for praying, and I suspect 90 percent of folate receptor alpha negative are going to be.

Unknown Executive: I don't think we've had that data, but you know theres, probably some overlap, but you can derive sort of 30% to 40% for folate receptor in the 80% to 90% is the prevalence of a frame in ovarian.

David Berman: In terms of the adjuvant we have the atom trial which is a well-designed standard B-lapse-free survival endpoint it's the standard endpoint use globally for full approval. So this is a trial that we believe will give us a full approval label with high confidence in the adjuvant setting. We are aware that there's competition in the neo-adjuvant setting and I think it's too early for us to comment in terms of that.

Unknown Executive: I'll just add that what we've continually seen, we saw in melanoma, BRAF mutant, and wild-type, and with the EGFR, because we've looked at that, the mutational effects in the lung, that we see brain expression independent of whether there's a mutation or not. And so, although, as Mohammed said, we don't have the exact overlap with folate receptor alpha, I suspect 90% of folate receptor alpha positives are going to be positive for brain, and I suspect 90% of folate receptor alpha negatives are going to be. I suspect that, but we just don't have that data right now.

Unknown Executive: I'll just add that what we've seen.

Unknown Executive: We saw in melanoma BRAF mutant wild type.

Speaker Change: And the and.

Unknown Executive: And with the Egfr because we've looked at that.

Speaker Change: Mutational status in line that we see playing expression independent of whether there's a mutation or not and so although as I said, we don't have the exact overlap with folate receptor Alpha I suspect, 90% of folate receptor Alpha positive we're gonna be.

Ralph Torbay: Well if you want to talk about the AI Thank you David. So we're very excited about this tool actually because when you recall we're discussing initially how our approach to addressing the market particularly in the US. We talked about the fact that there's a higher density at academic accounts and then after that it tells off with very low density in the community and one of the challenges is how do you address that low density those patients that pop off you know once a year or once every other year and really now that AI has gotten to the place where some of the predictive models have become very good we're leveraging that ability to predict based on on historical data where the patients and when the patients might pop in in some of the different practices and that's enabled us to find patients and 10 reps on a just in time basis which allowed us to basically keep our rep footprint. The same. Understood. Thank you.

Unknown Executive: Positive for brain and I suspect, 90% are folate receptor alpha negative are going today I suspect that that we just don't have that data right now.

Mohammed Dar: I suspect that we just don't have that data right now. Okay. Thanks so much. Thanks for taking my question. Thank you.

Unknown Executive: Okay.

Speaker Change: So Mike Thanks for taking my question.

Ahu Demir: Thank you. Our next question comes from the line of Ahu Demir with Lattenberg Thalmann.

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

Speaker Change: Thank you. Our next question comes from the line of right John Sharma with Goldman Sachs. Please proceed with your questions.

Rajan Sharma: Our next question comes from the line of Rajan Sharma with Goldman Sachs. Please proceed with your question. Hi. Thanks for taking my question. So, I'm just coming back to Kim Track Dynamics. And I just wanted to get your thoughts on how you see pricing evolving in the long term. So, I think there's slide 10 where you laid out the increased patient opportunity with the additional indications, but just given the extent of that potential volume uplift, you expect there to be some pressure on price both in the US and in Europe. And I guess, related to your comments on Europe, if there is kind of downward pressure on price with these additional indications, do you think that the European launch would be viable for those?

Ahu Demir: Please proceed with your question. Good morning. Thank you for taking my question.

Rajan Sharma: Hi, thanks for taking my question. So I'm just coming back to Kim track dynamics.

Ahu Demir: Good morning, thank you for taking my questions. We have two questions from us. The first one is on the lung cancer program. When you present data, use the Disclosed Data Format.

Speaker Change: Hi, Thanks for taking my question, so I'm, just coming back to <unk> dynamics and I just wanted to get your thoughts on how you see pricing evolving in a long time. So I think it was slide 10, where you laid out being the patient opportunity with the additional indications, but just given the extent of that potential volume uplift do you expect that should be some press.

Rajan Sharma: And I just wanted to get your thoughts on how you see pricing evolving in the long term. So I think it was slide 10, where you laid out the increased patient opportunity with the additional indications. But just given the extent of that potential volume uplift, you expect there to be some pressure on price both in the US and in Europe. And I guess, related to your comments on Europe, if there is any kind of downward pressure on price with these additional indications, do you think that a European launch would be viable for them?

Ahu Demir: Unknown Attendee You're cut off. If you could repeat your first question, please.

Speaker Change: Sure on price both in the U S and in Europe, and I guess related to your comments on Europe. If there is kind of diamond pressure on price with these additional indications do you think the European launch would be viable for those and then just to follow up and sorry, if I missed it but in ovarian cancer do you expect to include.

Alex: Our next question comes from the line of Peter Lawson with Spark Place. Please proceed with your question. Hey, good morning. This is Alex on repeat. Thank you for taking our questions. Just had two on the ovarian update. So assuming data is supportive. Would you pursue a monotherapy or chemo combination approval in the in the platinum resistance setting? Or would the goal be to maybe try to go sort of directly into earlier lines of therapy and combination with chemo? Thank you, Alex, David.

Rajan Sharma: And then just to follow up and sorry if I am missed it, but in a varying cancer, do you expect to include folate receptor alpha positive patients in that trial as well?

Speaker Change: Alright receptor alpha positive patients and not trying to as well.

Rajan Sharma: And then just to follow up, and sorry if I missed it, but in ovarian cancer, do you expect to include folate receptor alpha positive patients in that trial as well? And then just one follow-up question on HIV: could you tell me where you think those could go? So I think at the minute you said 300 was the upper level related to that; how high do you think you can dose? Thank you.

Rajan Sharma: And then just one follow-up on HIV, if I could, where do you think dose could go? So, I think at the minute you said 300 is the upper level related to that. How high do you think you can dose? Thank you. Great. Thank you, Rajan. I think there are several questions.

Speaker Change: And then just one follow up on H I V. If I could why do you think that could go. So I think the minute you said 300 is the upper level.

Rajan Sharma: Related to that how how high do you think you can dose. Thank you.

Unknown Executive: Great. Thank you, Rajan. I have several questions. Maybe we'll start with HIV, and then we'll go from there to commercial, correct? Yeah.

Ahu Demir: I was asking how many patients' disclosures that you would have from lung cancer and what percentage would have monotherapy versus combination therapy. And I have another one.

Speaker Change: Great. Thanks, Krish and I think several questions, maybe we'll start with the HIV.

Ahu Demir: Thank you. Thank you, Ahu. I would say it's too early to say, but I'll give it to Mohammed to tell you.

David Berman: Yeah, so Alex, I guess it's important to understand, you know, to remind about our what insights we've made. First of all, our platform works really well with disease control. It works very well, you know, it increased activity in earlier lines. And we think it works best in combinations in a very intense or different, which is different from containers. There's these two major disease segments and of course multiple different combinations. So we have to generate the data before we decide on what the next step is.

Mohammed Dar: Thanks for the question. In terms of lung cancer, as David mentioned, it is obviously a more heterogeneous setting compared to melanoma, and we are still in the initial signal detection mode, but in terms of patients, it will be likely a smaller data set than melanoma and ovarian, and we will likely have more combo patients than monopatients for the reason David mentioned, that for monotherapy, we have to select for preying, and with combo, we are aligned regardless of preying steps.

David Bourbon: Maybe we'll start with the HIV, and then we go there to commercial question. Yeah. So, with the HIV, I mean, if you remember, we showed at 15 micrograms, we're already seeing target engagement because we saw IELT sets. Without platform, you don't need to give a lot. With Kim Track, it was in the 64-68 microgram dose. We see a survival benefit. So, we don't know how high we can go. We're going to go as high as needed, but we certainly know that, you know, you don't need to go up to milligram doses with our platform. In terms of the folate receptor alpha, we don't exclude prior folate receptor alpha.

Speaker Change: And then we'll go from there to two commercial yeah. So with the HIV I mean, if you remember we showed at 15 micrograms were already seeing target engagement, because we saw I offsets.

Ahu Demir: My second question is on the HIV program. You touched on the viral load and also the rebound rate. What would give you confidence to move forward from the MAPS results? Would you be looking for... What data would you be looking for? and many more combinations like that.

Unknown Executive: So with HIV, I mean, if you remember, we showed at 15 micrograms, we're already seeing target engagement because we saw IL-6. With our platform, you don't need to give a lot. With ChemTrack, it was at the 64 and 68-microgram dose that we saw a survival benefit, so we don't know how high we can go. We're going to go as high as needed, but we certainly know that you don't need to go up to milligram doses with our platform.

David Berman: Yeah, it's a really good question, Ahu, because, of course, you know, we're pioneering this area here. No one has generated the data thresholds for what, you know, what's required to move forward.

David Berman: I would say at this stage, any evidence of activity that is definitely related to, you know, antiviral activity would be really intriguing to us because no one's been able to show that. So we're looking at whether you can reduce the viral reservoir and whether you can delay or alter the rebound kinetics. Anything, I think, here would be interesting for us to continue. Of course, at the end of the day, it's going to have to be an antiviral delay and rebound that is going to be the end point.

David Berman: But I think any insights we make here are going to be important for us. So the immediate next steps are for us to generate more data and to get to higher doses because we only have a few patients per cohort. Yeah, and I would just add one thing.

David Berman: Yeah, and I would just add one thing, I think you talked about combination therapy, just to remind you that we do it, the first part is on top of the antiretroviral. Thank you so much.

Unknown Executive: With our platform you don't need to give a lot.

Speaker Change: With Kim track it wasn't 64, 68 microgram dose, we see a survival benefit so.

Unknown Executive: We don't know how high we can go we're gonna go as high as needed, but we certainly know that you don't need to go up the milligram doses with our platform.

David Berman: So the immediate next steps are more chemotherapy combinations in the platinum resistance setting. And then as we talked about more platinum combinations and and the system at combination in the platinum sensitive. This is the data set that we think will enable us to make the best decision on what the next study is. P rock or pizza? Okay, great. And do we actually see any best combination patients in the three key updates? No, there won't be any emphasis on combinations in this update. Okay, thank you. Thank you.

Unknown Executive: In terms of folate receptor alpha, we don't exclude prior folate receptor alpha therapy. In fact, we have had a few patients who had prior ADC enroll in our trial. Our approach, once again, is not to replace the MRVA, it's not to go head to head, which is why it's added on to chemotherapy. And so it's independent of the MRVA data. And Ralph, can you comment on reimbursement? Just to reiterate here, I don't think we have any issues in the U.S., but it's mostly the EU. Go ahead, Ralph, please.

Unknown Executive: In terms of the folate receptor alpha.

Unknown Executive: We don't exclude prior folate receptor Alpha in fact, we have had a few patients who were who had prior ADC and rollout for our trial.

Ralph Torbay: In fact, we have had a few patients who had prior ADC and roll on to our trial. Our approach, once again, is not to replace the murder effect. It's not to go ahead, ahead, which is why it's to add on to chemotherapy. And so it's independent of the murder data.

Unknown Executive: Our approach once again is not to replace.

Ralph Torbay: The marathon, it's not to go head to head, which is why it's the add on to chemotherapy and so.

Ralph Torbay: It's independent of the market data.

Ralph Torbay: And Ralph, can you comment on the reimbursement just to reiterate here about things we have any issues in the US, but it's mostly the EU. Go ahead, Ralph, please. Sure, happy to. So first of all, our pricing strategy really depends on the benefit that we see from the data, right? So if it brings benefit, significant benefits patients and society, that's how we prices are further indication. To your question on the US and to be just point, we have not seen any downward pressure in the US so far. In fact, I expect that if the data is good and cutaneous, given that these are setting the pie on that need.

Ralph Torbay: And then also can you comment on the reimbursement just to reiterate here I don't think we have any issues in the U S. But it's mostly the yeah go ahead. Please.

Ahu Demir: Our next question comes from the line of a who demir with Latinburg salmon. Please proceed with your questions. Good morning. Thank you for taking my questions. Two questions from us. First one is on the lung cancer program. When you present data. Disclose data format. You cut off if you could repeat your first question. Please.

Ralph Torbay: Sure, happy to. So, first of all, our pricing strategy really depends on the benefit that we see from the data, right? So, if it brings significant benefits to patients and society, that's how we price our further indications. To your question on the U.S. and to Bahija's point, we have not seen any downward pressure on the U.S. so far. In fact, I expect that if the data is good and cutaneous, given that these are settings of high unmet need and with small patient populations, we would not have to erode the price significantly in the U.S.

Ralph Torbay: Sure happy to so first of all our pricing strategy really depends on the benefit that we.

Ralph Torbay: We see from the data right. So if it brings a benefit significant benefit to patients and society.

Speaker Change: Our wheat prices.

Bahija Jallal: A further indication to a question on the U S and it's a basis point, we have not seen any downward pressure in the U S. So far.

Ralph Torbay: In fact, I expect that if the data is good and.

Ralph Torbay: Continuous given that these are settings of high unmet need.

Mohammed Dar: I was asking how many patients disclosure that you would have from the lung cancer and what percentage would have monetary versus combination. And I have another question. Thank you. I would say it's too early to say, but I'll give it to Mohammed to tell you. Sure. Thanks. Thanks for the. Thanks for the question. In terms of lung cancer, as you know, David mentioned, it is obviously a more. It's a more heterogeneous setting compared to compared to melanoma.

Ralph Torbay: And with small patient populations that we would not have to enroll, the price significantly in the US; the other hand, in Europe, you have a good question in terms of price erosion. And I think it's too soon to tell; we need data for us to decide whether we'll be launching in Europe or not, although it is a very tough market access environment. One of the tough things I've seen through all my years of working with Europe. Thank you.

Ralph Torbay: And with small patient populations that we would not have to erode the price significantly in the U S. The other hand in Europe.

Ralph Torbay: On the other hand, in Europe, you have a good question in terms of price erosion, and I think it's too soon to tell. We need data for us to decide whether we'll be launching in Europe or not, although it is a very tough market access environment. Frankly, one of the toughest I've seen through all my years of working with Europe.

Speaker Change: You have a good question in terms of price erosion and I think it's too soon to tell we need data for us to decide whether it will be launching in Europe or not.

Ralph Torbay: Although it is a very tough market access environment frankly, one of the toughest I've seen so all my years working with Europe.

Avantika Joshi: Thank you. Our next question comes from the line of Avantika Joshi with Mizuho. Please proceed with your question. Hi, this is Avantika on behalf of Greg. I just had a question. Are you still looking for manifest in?

Operator: Thank you. Our next questions come from the line of Ethan Markowski with Needham and Company. Please proceed with your question.

Speaker Change: Thank you. Our next question is coming from the line of Ethan Mark Koski with Needham <unk> Company. Please proceed with your questions.

Mohammed Dar: But in terms of, in terms of patients, it will be likely a smaller data set than melanoma and ovarian. And we will likely have more combo patients than mono patients for the reason David mentioned that for monetarily, we have to select for premium with combo. We are lying regardless of print steps. Mohammed, that's helpful.

Ethan Markowski: Our next questions come from the line of Ethan Markowski with Needham and Company. Please proceed with your questions. Hi, this is Ethan on for Gil. Thank you for taking our questions. I think most of them have been answered thus far, but just wondering.

Avantika Joshi: Yeah, you know, we certainly are in this strong scientific rationale. But as for the team, I've asked them to focus, right?

David Berman: We're launching a global phase three cutaneous melanoma. We are committed to following up on the signals in ovarian cancer and looking for signals in lung. And we've certainly had the sites focus on those as well. We do have ongoing phase one exploration in other tumors, but we've had to focus on these. And so we are certainly interested and continue to be interested in other tumors like endometrial.

Ethan Markowski: Hi, this is Ethan on behalf of Gil. Thank you for taking our questions. I think most of them have been answered thus far, but I'm just wondering, so I know endometrial is not one of the focus indications for PREIM, but wondering if you plan on going into a similar strategy there where moving maybe combination and earlier lines like you're planning to do for non-small cell lung cancer and ovarian. And then for ChemTrac, you talked about the difficult reimbursement in Europe. Will growth there really be mostly driven by just adding additional countries, or do you think that those dynamics are likely to change over time?

Ralph Torbay: Yeah, Hi, this is Ethan on for Gil. Thank you for taking our questions I think most of them been answered thus far but.

Ethan Markowski: Im just wondering so I know endometrial its not one of the focus indications for frame, but wondering if you plan on going into a similar strategy. There were moving maybe combination in earlier lines like Youre planning to do in non small cell lung cancer and ovarian and then for contract you've talked about the <unk>.

Mohammed Dar: So I know Endometriol is not one of the focus indications for praying, but wondering if you plan on going into a similar strategy there where moving maybe combination in earlier lines, like you're planning to do a non-small cell on cancer and ovarian. And then for contract, you talked about the difficult reimbursement in Europe. Will growth there really be mostly driven by just adding additional countries? Or do you think that those dynamics are likely to change over time? Thank you. Thank you, Ethan.

Speaker Change: <unk> reimbursement in Europe.

David Berman: My second question is on the HIV program. You touched on the viral load and also the rebounds, right? Would give you confidence to move forward from the meds would you be looking for, what data would you be looking and train to combinations for that program? Yeah, David. Yeah, it's a really good question, Ahu, because of course, you know, we're pioneering this area here. No one's generated the data thresholds for what, you know, what's required to move forward.

Speaker Change: <unk> growth there really be mostly driven by just adding additional countries or do you think that those dynamics are likely to change over time. Thank you.

Mohammed Dar: Go ahead, Mohammed. I have to admit that I'm not...

Speaker Change: Thank you Ethan and Mohammed you could take the first one and developed T V.

Ralph Torbay: Mohammed, you could take the first one and the last, maybe on Europe. Thanks, Ethan, for the question. I think, you know, David mentioned the focus has been on ovarian melanoma and lung for now. So the Endometriol data that we're generating is really in monotherapy with some of the chemotherapy that are used in the late line. And, you know, right now, we don't have current plans to explore endometriol in order until we actually generate data in the late lines to guide. Rob. Sure. So the there is in fact a very tough environment in Europe as we've been discussing.

Speaker Change: On Europe.

Unknown Executive: Thank you.

Mohammed Dar: We would have to simplify them a bit. Sorry about that.

Mohammed Dar: I don't want to retain the members, but go ahead. Thank you very much. Bye.

Unknown Executive: Thanks, Ethan, for the question. I think, you know, as David mentioned, the focus has been on ovarian, you know, melanoma, and lung cancer for now. So the endometrial data that we're generating is really in monotherapy with some of the chemotherapies that are used in late-line. And, you know, right now, we don't have current plans to explore endometrial and ergo lines until we actually generate data in late-lines to guide us. Thank you.

Speaker Change: Thanks, Ethan for the question.

Mohammed Dar: Are those numbers referring to the Half-Life Extended and the A24s? Yeah, the Half-Life Extended.

Ethan Markowski: As David mentioned, the focus has been on ovarian and melanoma and lung for now so the endometrial data that we're generating it's really.

Unknown Executive: In monotherapy with some of the Chemotherapies that are used in in late line in <unk>.

David Berman: I would say at this stage, any evidence of activity that is definitely related to, you know, antiviral would be really intriguing to us, because no one's been able to show that. So we're looking at, can you reduce the viral reservoir and can you delay or alter the rebound kinetics? Anything I think here would be interesting for us to continue. Of course, at the end of the day, it's going to have to be an antiviral delay and rebound that is going to be the end point, but I think any insights we make here are going to be important for us.

Unknown Executive: Right now we don't have current plans to explore endometrial and auto lines until we actually generate data and in the late lines. The guide.

Unknown Executive: Rob.

Unknown Executive: Sure. So, there is, in fact, a very tough environment in Europe, as we've been discussing. However, we've had a lot of successes when it comes to reimbursement. So we had nine launches in the first half of the year. And we expect some of that marginal growth will come from further additional launches because we're currently in negotiations with several companies.

Mohammed Dar: As David mentioned earlier, we are certainly applying all of the learnings from our F1-Succeed PREIM program to those two programs. We know where PREIM is expressed.

Unknown Executive: Sure.

Unknown Executive: So.

Speaker Change: The there is in fact, a very tough environment in Europe is as we've been discussing however.

Ralph Torbay: However, we've had a lot of successes when it comes to reimbursement. So we've had nine launches in the first half of the year. And we expect some of that marginal growth will come from further additional launches because we're currently negotiating with several. In addition to that, obviously, we're very well penetrated. The team has been doing a great job in Europe, so really, it's the launch that is driving the next level of growth.

Speaker Change: However, we've had a lot of successes, but when it comes to reimbursement. So we've had nine launches in the first half of the year.

Unknown Executive: We expect some of the marginal growth will come from further additional launches are because.

David Berman: So immediate next steps are for us to generate more data and to get to higher doses because we only have a few patients per cohort. Yeah, and I would just, I think you talked about the combination just to remind you that to do it, the first part is on top of the antiviral survival. Thank you.

Unknown Executive: Because we are currently in negotiations with several countries.

Unknown Executive: In addition to that I mean, obviously, we're very well penetrated the team has been doing a great job in Europe.

Unknown Executive: So really it's the launch is driving the next level of growth.

Avantika Joshi: Our next question comes from the line of Haventika, Joshi with Mizzouho. Please proceed with your question. Hi, this is Avantika on for Greg. I just had a question. Are you still looking up for none of us in tumors beyond melanoma, ovarian, and non-small cell? Yeah, you know, we certainly are in this strong scientific rationale, but as at the team, I've asked them to focus, right? We're launching a global phase 3, 15 is melanoma.

Unknown Attendee: Thank you. There are no further questions at this time.

Bahija Jallal: Thank you. There are no further questions at this time. I'd like to hand the call back to Bahija Jallal for closing comments.

Mohammed Dar: So, yes, those trials are designed flexibly, so we have multiple options in terms of the types of patients that we can enroll. Okay, thank you. Thank you. Our next question comes from the line of Jeffrey Hung with Morgan Stanley. Please proceed with your, Hello, this is Selena on.

Speaker Change: Thank you there are no further questions at this time I'd like to hand, the call back into it but he said on July <unk> for closing comments.

I'd like to hand the call back at the Bahija Jallal for closing comments. Thank you, operator. So once again, I just want to thank you for your patience, first of all, and continued trust and commitment, and we're now close to call. Thank you. Thank you; this does include today's teleconference. We appreciate your participation. May disconnect your lines at this time and enjoy the rest of your day. Thank you.

Operator: Thank you, operators. So once again, I just want to thank you for your patience, first of all, and continued trust and commitment. And we now close the call. Thank you.

Speaker Change: Thank you operator, so once again I just want to thank you for your patience first of all and continued trust and commitment and we'll now close the call. Thank you.

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

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

Speaker Change: Thank you. This does conclude today's teleconference. We appreciate your participation you may disconnect. Your lines at this time enjoy the rest of your day.

Jeffrey Hung: Yeah, I'm happy to take both of those. So, you know, ctDNA response criteria are still in their early stages. Externally, companies have looked at lung cancer, for example, at a 0.5 log reduction. So there's precedent for that, called the molecular response.

David Berman: In our cutaneous melanoma data, that 0.5 log reduction did seem to, sorry, in iubial melanoma data, that 0.5 log reduction did seem to be a good threshold cutoff for correlating with survival. We saw the same correlation in cutaneous melanoma, and we'll share that data on ctDNA, and on the ovarian data at ESMO. But it does look like that 0.5 log reduction, I think, is a good log reduction, is a good threshold for us, based on the data we have today.

David Berman: In terms of the endometrial timeline, I think it's a little too soon to guide because, as I mentioned, we've asked the team to focus on ovarian lying and cutaneous melanoma. We've asked the sites to focus on that as well.

Avantika Joshi: We are committed to following up on the signals in ovarian and to look for signals in line, and we've certainly had the sites focus on those as well. We do have ongoing phase 1 exploration in other tumors, but we've had to focus. And so we are certainly interested and continue to be interested in other tumors like endometrial.

Operator: [music].

Mohammed Dar: And one more question was, for the earlier stage assets for P115C and P119C, are you initially running basket studies? Are you focusing on specific tumors? Thank you. I have to admit that I'm not, I don't want to retain the members, but go ahead. Are those numbers referring to the half-life extended in the A-24? Yeah, the half-life extended in the A-24. We would have to simplify them. Yeah. Sorry. That's not an issue.

Operator: Mhm.

Operator: Hum.

Operator: Yeah.

Operator: [music].

Operator: Uh-huh.

Operator: Yeah.

Mohammed Dar: As David mentioned earlier, we are certainly applying all the learnings from our F-1 of 6-E, a brain program to those two programs we know where a brain is expressed. So, yeah, those trials are discussed responsibly, so we have multiple options in terms of the types of patients that can enroll. Okay, thank you. Thank you.

Jeff Riad: Our next question comes from the line of Jeff Riad, with Morgan Stanley, please proceed with your question. Hello, this is Selena on for Jeff. There are two questions here on frame for the melanoma data CT DNA responders were defined as 0.5 log reduction. Do you expect that threshold for meaningful correlation to longer survival to be similar across indications like an ovarian in line? And the second question from us, when might we expect an update from the endometrial cohort?

Jeff Riad: Thank you. Yeah, I'm happy, yeah, I'm happy to take both of those. So, you know, CT DNA response criteria are still in their early stages. Externally, companies have looked in line cancer, for example, at a 0.5 log reduction. So, there's precedence of that called a molecular response. In our continuous melanoma data, that 0.5 log reduction did seem to, sorry, an iuvial melanoma data, that 0.5 log reduction did seem to be a good threshold cutoff for correlating with survival.

Jeff Riad: We saw the same correlation in continuous melanoma, and we'll share that data on CT DNA at, on the ovarian data at as well. But it does look like that 0.5 log reduction, I think, is a good log reduction. It is a good threshold for us based on the data we have today. In terms of the endometrial timeline, I think it's a little too soon to guide, because as I mentioned, we've asked the team to focus on ovarian lying in CT DNA.

Jeff Riad: No, no, no, we've asked the sites to focus on that as well, too. Thank you. Our next question comes from the line of Noreen Kipria with Capital One Securities. Please proceed with your question. Hi, good morning. I can rest on all the progress. I guess my first question sort of follows up on the last one. In terms of, you know, the premium results that you'll be presenting at asmo, you know, you've observed benefit with kin-track outside of recess response, right?

Jeff Riad: So can you remind us how you're tracking response rates underestimate? You know, should we just focus on the disease control rates or, you know, you mentioned that they'll be CT DNA. Is there anything else? Yeah, it's a good question. I mean, we certainly saw this with UVL melanoma. This eventations would take both radiographic increase in size, that benefit, that survival benefit, that line from survival. We saw a few patients of those with brineticus in the cutaneous melanoma.

Jeff Riad: We will, I think, continue to see that in the ovarian and the line as well. I think the way that we're looking at how do you measure benefit, of course, is CT DNA, which is the way to measure independent of radiographic, but also looking at treatment beyond progression. Because this is where the investigator sees the patient having a radiographic increase in size, but they feel the patient's benefiting. So if we saw this early, the treatment beyond progression was and a good initial indicator.

Jeff Riad: Now, although we do see this, TD benefits, we see very strikingly for Kintrak, we feel that with brineticus disease control rate is an equally, is a very good metric to predict PFF. And in fact, my sense of the data is that although brineticus does have benefit in the TD, it is more of a disease, it has more disease control than Kintrak did. But I think at the end of the day, of course, survival will be the ultimate endpoint.

Jeff Riad: I do feel PFF is still a good endpoint for brineticus. Mohammed, anything to add on that? No. Okay, that's helpful. And I just sort of stick into the Avarian Cancer topic. You know, what's a distribution of praying compared to folate receptor? Is there like an overlapped there? I guess I'm just trying to gauge, you know, if you expect to see any patients coming off of state eula hair, you know, into this, would there be any of those types of patients in the combo?

Jeff Riad: Sure, I'm very happy to address that. So for praying per se, it's very similar to, you know, very similar to melanoma, it's around, you know, 80 to 90 percent. With the versus the folate receptor alpha, um, for alahari, it's like, you know, between 35 and 40 percent. The exact overlap, I, you know, I don't, um, I don't think we have that data, but you know, there's probably some overlap, but you can derive sort of 30 to 40 percent for folate receptor and 80 to 90 percent is the prevalence for praying in a variant.

Jeff Riad: I just said that what we've seen, um, continually we saw in melanoma B-raft mutant wild type, um, in the, um, and, and with the EGFR, because we've looked at that, uh, mutations as in lying, that we see praying expression independent of whether there's a mutation or not. And so although, as I said, we don't have the exact overlap with folate receptor alpha, I suspect 90 percent of folate receptor alpha positive are going to be, uh, positive for praying and I suspect 90 percent of folate receptor alpha negatives are going to be, um, I suspect that we just don't have that data right now. Okay. Um, thanks so much. Thanks for taking my question. Thank you.

Rajan Sharma: Our next question comes from the line of Rajan Sharma with Goldman Sachs. Please proceed with your question. Hi. Thanks for taking my question. So I'm just coming back to Kim Track Dynamics and, um, I just wanted to get your thoughts on how you see pricing evolving in the long term. So then give us slide 10 where you laid out the increased patient opportunity with the additional indications, but just given the extent of that potential volume uplift, you expect there to be some pressure on price both in the US and in Europe.

Rajan Sharma: And I guess related to your comments on Europe, if there is kind of downward pressure on price with these additional indications, do you think that the European launch would be viable, um, for those? And then just to follow up and sorry if I missed it, but in varying cancer, do you expect to include folate receptor alpha positive patients in that trial as well? Um, and then just one follow up on HIV if I could, um, where do you think dose could go? So I think at the minute you said 300 is, um, the upper level related to that, how, how high do you think you can dose?

Rajan Sharma: Thank you.

Unknown Attendee: Great. Thank you, Roseanne. I think there are several questions.

David Berman: Maybe we'll start with the HIV. And then we go from there to commercial. Yeah. So with the HIV, I mean, if you remember, we showed at 15 micrograms, we're already seeing target engagement because we saw IELTSETS. With our platform, you don't need to give a lot. With Kintrak, it was in the 64, 68 microgram dose, we see a survival benefit. So we don't know how high we can go. We're going to go as high as needed, but we certainly know that, you know, you don't need to go up to microgram doses with our platform.

David Berman: In terms of the folate receptor alpha, we don't exclude prior folate receptor alpha. In fact, we have had a few patients who had prior ADC and roll on to our trial. Our approach, once again, is not to replace the murror effect. It's not to go ahead the head, which is why it's to add on to chemotherapy. And so it's independent of the murder data. And we're off.

Ralph Torbay: You can you comment on the reimbursement just to reiterate here. I don't think we have any issues in the US, but it's mostly the day you go ahead the rough. Sure, happy to. So first of all, our pricing strategy really depends on the benefit that we see from the data, right? So if it brings benefit significant benefits patients and society that's how we prices are further indication. To your question on the US, and to be just point, we have not seen any downward pressure in the US so far.

Ralph Torbay: In fact, I expect that if the data is good and cutaneous, given that these are setting the pie on that need. And with small patient populations that we would not have to enroll the price significantly in the US, the other hand in Europe, you have a good question in terms of price erosion.

Ralph Torbay: And I think it's too soon to tell we need data for us to decide whether we'll be launching in Europe or not, although it is a very tough market access environment. I think one of the tough things I've seen through all my years working with Europe. Thank you.

Mohammed Dar: Our next question is come from the line of Ethan Markowski with the need him and company. Please proceed with your questions. Yeah, hi, this is Ethan on for Gil. Thank you for taking our questions. I think most of them have been answered thus far, but just wondering. So I know I know me too. It's not one of the focus indications for praying, but wondering if you plan on going into a similar strategy there where moving maybe combination in earlier lines, like you're planning to do a non small cell on cancer and ovarian.

Mohammed Dar: And then for contract, you talked about the difficult reimbursement in Europe will growth there really be mostly driven by just adding additional countries, or do you think that those dynamics are likely to change over time. Thank you. Thank you, Ethan. Mohammed, you could take the first one and the last maybe on Europe. Thanks Ethan for the question. I think, you know, David mentioned the focus has been on ovarian melanoma and lung for now.

Mohammed Dar: So the endometrial data that we're generating is really in monotherapy with some of the chemotherapy that are used in the late line. And, you know, right now, we don't have current plans to explore endometrial in order until we actually generate data in the late lines to guide. Rob. Sure. So the there is in fact a very tough environment in Europe as we've been discussing. However, we've had a lot of successes when it comes to reimbursement.

Mohammed Dar: So we've had nine launches in the first half of the year. And we expect some of that marginal growth will come from further additional launches because we're currently negotiations with several, in addition to that, obviously, we're very well penetrated, the team has been doing a great job in Europe, so really it's the launch is driving the next level of growth.

Unknown Attendee: Thank you, there are no further questions at this time.

Bahija Jallal: I'd like to hand the call back at the Bahija Jallal for closing comments. Thank you, operator. So once again, I just want to thank you for your patience, first of all, and continue trust and commitment and we're now close to call. Thank you.

Unknown Attendee: Thank you, this does include today's teleconference. We appreciate your participation. May disconnect your lines at this time and enjoy the rest of your day. Thank you.

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