Q4 2023 Immunocore Holdings PLC Earnings Call

Operator: That's my name, worse than that. Greetings. Welcome to the Immunocore fourth quarter financial results conference call. At this time, all participants are in a listen-only mode.

Worse than that.

Greetings and welcome to the mean of course fourth quarter financial results Conference call. At this time all participants are in a listen only mode. 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. Please note. This conference is being recorded I will now turn the call.

Operator: 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. Please note this conference is being broadcast. I will now turn the conference over to Clayton Robertson, Head of Investor Relations. Thank you. Thank you, Dale.

Over to Clayton Robertson head of Investor Relations. Thank you you may begin.

Thank you Daryl welcome everyone to our Q4 and full year 2023 financial results call.

Clayton Robertson: Welcome everyone to our Q4 and full year 2023 financial results call. Before we begin, I would like to remind you that this call will contain forward-looking statements within the meaning of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995. These include expectation plans concerning future events, prospects, and performance, including with respect to commercialization, clinical development, and trials, regulatory approvals, and financial results. However, actual events may differ significantly from those indicated by these four different statements as a result of various important factors, including those disclosed in our filings with the SEC. And such statements represent our views only as of the date of this webcast and should not be replied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.

Before we begin I would like to remind you that this call will contain forward looking statements within the meaning of the safe Harbor provision under the private Securities Litigation Reform Act of 1995.

These include expectations.

Concerning future events prospects and performance, including with respect to commercialization clinical development trials regulatory approvals and financial results.

Actual events may differ materially from those indicated by these forward looking statements as a result of various important factors.

Oh, it was disclosed in our filings at the FCC.

And such statements represent our views only as of the date of this webcast and should not be replied upon as you.

Resenting our views as of any subsequent date.

We specifically disclaim any obligations to update such statements with that I'm now pleased to introduce Jim University, Dr. Zetsche law.

Dr. Paneja Jalal: With that, I'm now pleased to introduce Immunocore's CEO, Dr. Paneja Jalal. Thank you, Clay. Hello, everyone. With me today is Rob Torbay, our head of commercial. David Berman, our Head of R&D, and Brian DiDonato, our Chief Financial Officer. We will be happy to take your questions at the end. At Immunocore, we are driven by a clear mission to bring transformative immunomodulating medicines to patients. In 2023, we will continue to advance our three strategic pillars of maximizing the potential of chemtrails, advancing our clinical portfolio, and continuing to innovate for sustainable growth. Let's look at the first one.

Thank you play Hello, everyone.

With me today are Rob Stewart, our head of commercial.

So.

David Berman, our head of R&D, and Brian did Donato, our Chief Financial Officer.

We would be happy to take your questions at the end.

I mean of course, we are driven by a clear mission to bring transformative immuno modulating medicines to patients.

In 2023, we continue to advance our three strategic pillars of maximizing the potential of keep track.

I think our clinical portfolio.

And continuing to innovate for sustainable growth.

If you look at the first one.

Dr. Paneja Jalal: On KimTrack last year, we achieved $239 million in net KimTrack sales. Going into 2024, we see three growth opportunities. First, continuous commercial growth driven by the U.S. Second, midterm growth driven by Q4 data from the CEBI-AM trial. And third.

You can track last year, we achieved 239 million in net contract sales.

Going into 'twenty 'twenty, four we see three opportunities.

Continuous commercial growth driven by the U S.

Second mid term growth driven by Q4 data from J P. A M trial.

And third.

Dr. Paneja Jalal: Long-term growth with the ATOM trial expected to start recruiting this year. The second pillar of the portfolio. We continue to advance our clinical portfolio. With the announcement of our first CRAME Phase III trial in first-line advanced cutaneous melanoma, we intend to randomize the first patient in Q1. Crane clinical data updates in melanoma, ovarian, and lung will come to us in 2024. In reflecting our enthusiasm for the PRAME targets, we are advancing two new candidates into the clinic this year. In December, we submitted the CTA for a first-class candidate targeting P-Well in colorectal and GI cancers, and we continue to pursue a potential functional cure for HIV with phase one data for the first half or second half of 2024. The third pillar is innovation.

Long term growth with the atom trial expected to start to recruiting this year.

The second pillar on the portfolio.

We continue to advance our clinical portfolio with.

The announcement of our first frame phase III trial in first line advanced cutaneous melanoma, we intend to randomized the first patient in Q1.

Preclinical data updates in melanoma, ovarian and lung when it come to 'twenty 'twenty four.

Yeah, reflecting our enthusiasm for the prime targets, we are advancing two new candidates into the clinic this year.

In December we submitted the Cta for our first in class candidates targeting if you will in colorectal and Gi cancers.

And we continue to pursue a potential functional cure in HIV with phase one data.

For the first half or second half of 'twenty 'twenty four.

The first pillar is innovation.

Ralf: And last month, we announced that we had added two novel tissue-targeted autoimmune programs, one for type 1 diabetes, and the second for dermatology indications. You will hear more about each of these exciting programs from David. These additions expand the therapeutic areas we aim to treat to three. And now I'm happy to hand over to Ralf to share more information about the contract. Thank you very much. Hello, everyone.

Last month, we added.

We had added two novel tissue targeting autoimmune programs one for type one diabetes and the second for dermatology indications.

More about each of these exciting programs from David.

These additions expand the therapeutic areas, we aim to treat two or three.

And now I'm happy to hand over to <unk> to share more information about keep track.

Thank you for Asia.

Hello, everyone.

Ralf: 2023 was a catalyst year for Chemtrails. In less than two years from our first approval, we have transformed medical practice in aesthetic uveal melanoma and established pioneering TCR medicine as the first-line standard of care across all launch markets. We have treated over 2,000 patients globally since the start of our first clinical trial, and I'm very proud of this team's achievements and commitment to patients. Chemtruck is currently approved in 38 countries and launched and reimbursed in 12, with the publication of Kim Trach's long-term three-year overall survival in the New England Journal of Medicine. We continue to raise the bar of survival, and I look forward to the impact the team will have in 2024 leveraging the state. I will now take you through the figures and financial performance in more detail. For the full year 2023, KimTrack generated $238.7 million in net revenues, which represents a 70% year-on-year growth. In the fourth quarter, we reported $67.6 million in net revenues, which represents an 8% increase from the prior quarter. This growth was primarily driven by continued commercial progress in the United States.

One P 23 was a catalyst you forget truck.

In less than two years from our first approval, we have transformed medical practice in metastatic uveal melanoma and established is pioneering D C. Our medicine.

First line standard of care across all launch markets.

We have treated over 2000 patients globally since the start of our first clinical trial and I'm very proud of this team's achievements and commitment to patients.

Kim truck is currently approved in 38 countries and launched reimbursed and 12.

With the publication of Kim trucks long term three year overall survival in the New England Journal Medicine.

We continue to raise the bar of survival and I look forward to the impact of the team will have the 'twenty 'twenty four leveraging this data.

I will now take you through the figures in financial performance in more detail.

Yeah.

For the full year of 2023, Chimera generated $238 7 million in net revenues, which represents a 70% year on year growth.

In the fourth quarter, we reported $67 6 million in net revenues, which represents an 8% increase from the prior quarter.

This growth was primarily driven by continued commercial progress in the United States.

Ralf: In Europe, we launched in six new countries and reached pricing agreements with Italy and Germany. In France, we have been recognizing revenue since day one and have been accruing for an expected negotiated price. In the international region, we signed pricing agreements with Canada and Australia, which we are launching through the first half of the year. Our goal in 2024 is to continue our growth momentum in the United States and reach more patients globally, including our next country, Spain. We're also excited to potentially expand the benefit of ChemTrack to additional indications with our clinical program, which I will take you through in the next slide. We believe ChIMP-TRAC has significant potential for additional growth in the medium and long term, driven by two registrational clinical trials.

In Europe, we launched in six new countries and reached pricing agreements with Italy and Germany.

In France, we had been recognizing revenue since day, one and have been accruing for unexpected negotiated price.

In the International region, we signed pricing agreements with Canada, and Australia, which we are launching through the first half of the year.

Our goal in 2024 is to continue our growth momentum in the United States and reach more patients globally, including our next country, Spain.

We're also excited at the potential to potentially extend the benefit of Kim track two additional indications with our clinical program, which I will take you through in the next slide.

Okay.

We believe chimera has significant potential for additional growth in the medium and long term driven by two registrational clinical trials.

Ralf: The TEBI-AM study builds on the chemtruck phase 1-2 cutaneous melanoma data that has shown a 76% survival rate at one year with an acceptable safety profile. Enrollment is going well, and we expect top-line results from the Phase 2 portion in the fourth quarter of this year. All the evidence with ChemTrack points to our platform being potentially transformative in the early disease setting. We were honored to work with ERTC to launch the only ongoing registrational adjuvant study in uveal melanoma, the ATOM trial. We anticipate randomization to start in the second half of this year. Now, let's bring it all together on the next slide.

The <unk> study builds on the Kim truck phase one two continuous melanoma data.

Shown are 76% survival rate at one year with an acceptable safety profile.

Enrollment is going well and we expect topline results from the phase two portion in the fourth quarter of this year.

I'll be evidenced with Kim track points to our platform being potentially transformative in the early disease settings.

We were honored to work with E. R. A T C to launch the only ongoing Registrational adjuvant study in Uveal melanoma, the atom trial.

We anticipate randomization to start in the second half of this year.

Bringing it altogether in the next slide please.

Ralf: Today, we're only at the beginning of the Kintrack journey, where the benefit is focused on 1,000 patients with metastatic uveal malnourishment. With the KEVI-AM trial, we see the potential to help 2,000 to 4,000 additional patients with second line plus metastatic cutaneous malignancy. With the ATOM trial, we could be unlocking early-stage uvulonomer potential and bringing the benefit of KimTrack to up to 6,000 patients across all three indications. On a personal note, I am excited about our future because of this past year.

Today, we're only at the beginning of the contract journey or the benefit is focused on 1000 patients with metastatic uveal melanoma.

With the <unk> trial, we see the potential to have two to 4000 additional patients with second line plus metastatic cutaneous melanoma.

With the anthem trial, we could be on looking at the early stage, you've your mom them up with potential and.

And bringing the benefit of scheme trial to up to 6000 patients across all three indications.

On a personal note.

I am excited about our future because of this past year.

Ralf: I had the privilege of meeting one of the first patients in our clinical trial, a parent of four, who has been taking ChemTrac for seven years and is doing well. I also met our first patient in our early access program who remains well and on treatment, and a physician who expanded their practice to handle the volume of patients who are now surviving. These people remind us every day of why we need to persevere in helping patients and advancing science. I'll now hand it over to David to talk more about our project. Thank you, Ralph.

Had the privilege to meet one of the first patients in our clinical trial parents are for that has been taken Kim checked for seven years and is doing well.

I also met our first patient in our early access program remains well and on treatment.

And a physician who expanded their practice to handle the volume of patients who are now surviving.

These people remind us everyday of why we need to persevere and helping patients and advancing the science.

I'll now hand, it over to David to talk more about our pipeline.

Thank you Ralph I'm happy to share an update on our clinical stage portfolio and lets start with prime.

David: I'm happy to share an update on our clinical stage portfolio, and let's start with PREM. Our prime opportunity lies across multiple solid tumors, including melanoma, ovarian, lung, and endometrial carcinoma. By the end of this year, our franchise will include three clinical programs targeting the brain, including a program for HLA-A02 with the Half-Life extension and a program for patients who are HLA-A24 positive. Today, I will focus on the LEAP program, F106.

Our prime opportunity spans across multiple solid tumors, including melanoma ovarian and.

And endometrial carcinoma.

By the end of this year. Our franchise will include three clinical programs targeting trade, including a program for HLA E O too with the half life extension and a program for patients who are HLA <unk> 24 positive.

Today, I will focus on the leap program F 160.

David: Across the four major chemotypes we are studying with F106C, the melanoma data matured first and provided confidence to launch the Phase III PRISM-MEL301. We will share the melanoma monotherapy and N-type PD-1 combination data in the second quarter. After melanoma, the ovarian monotherapy and chemotherapy combinations have also been maturing.

Across the four major tumor types, we are studying with F 160, the melanoma data matured first and provided confidence to launch the phase III Prism Mel 301.

We will share the melanoma monotherapy and anti PD, one combination data in second quarter.

After melanoma.

Varian mono therapy, and chemotherapy combinations have been maturing and we are on track to share this data by third quarter.

David: And we are on track to share this data by third quarter for Lung. We are currently enrolling monotherapy and combination. Unlike ovarian and melanoma, where we enrolled all comers, for lung, we have focused on select subsets where we would expect to see initial signals before expanding more broadly. This data will continue to mature in the first half and will be shared by fourth quarter.

For lung, we are currently enrolling monotherapy and combinations, unlike ovarian and melanoma, where we enrolled all comers.

We are focused on select subsets, where we would expect to see initial signals before expanding more broadly. This data will continue to mature in first half and will be shared by fourth quarter.

David: Additional exploration continues, including endometrial, contract combinations, and dose confirmation. Several data points led to the initiation of the Phase 3 trial in first-line melanoma, including F106C monotherapy activity in heavily pre-treated patients, the ability to combine with N-type PD-1, and insights that our platform works best in early stage disease. We have open clinical sites for the Phase III trial and expect to start randomizing patients in the near future. We are pleased to have a clinical trial collaboration and the Volumad supply agreement with BMS for this trial. I will now turn to highlight the power of our target discovery engine with a novel first-in-class target against pwil-1. R117C is the first immunotherapy to target PWO1, a protein that is expressed in colorectal carcinoma, a tumor that has historically been insensitive to check. PEEWL is an attractive target since it is not expressed in normal vital tissues, is a negative prognostic marker, and is expressed in about a quarter of colorectal cancer patients.

Additional exploration continuous including endometrial contract combinations and dose confirmation.

Several data points led to the initiation of the phase III trial in first line melanoma, including F. One and six see monotherapy activity in heavily pretreated patients.

The ability to combine with anti PD, one and insights that our platform works best in early stage disease.

We have opened clinical sites for the phase III trial, and expect to start randomized patients in the near future.

We are pleased to have a clinical trial collaboration and the volume at supply agreement with BMS for this trial.

I will now turn to highlights the power of our target discovery engine with a novel first in class target against P well one.

Yeah.

Our 170 <unk> is the first immunotherapy to target people want a protein which is expressed in colorectal carcinoma, a tumor that has historically been insensitive to checkpoint.

He will is an attractive target since it is not expressed in normal vital tissues is a negative prognostic marker and has broad expression and about a quarter of colorectal cancer patients.

David: The CTA in Europe was submitted in December of last year, and we are on track to start the trial by the second half of this year. Moving now from oncology to HIV. In addition to redirecting T-cells to kill cancer cells, we believe that technology can be used to redirect T-cells to kill virally infected cells. For HIV, the current standards of care for antiretroviral therapy block replication that cannot eliminate the virus, which hides it as a reservoir in CD4 T-cells.

The Cta in Europe was submitted in December of last year.

And we are on track to start the trial by the second half of this year.

Turning now from oncology to HIV.

In addition to redirecting T cells to kill cancer cells. We believe our technology can be used to redirect T cells to kill virally infected cells.

For HIV the current standards of care of anti retroviral therapy, black replication, but cannot eliminate the virus, which high as it is a reservoir in CD four T cells and.

David: In the single ascending dose portion of the M113v trial, we demonstrated safety and biomarkers indicating target engagement. The goals of the ongoing multiple A-thinning dose portion are to demonstrate antiviral activity, including one, reducing the reservoir in blood, and two, delaying the viral rebound. As we round up the clinical pipeline, I will transition to highlighting further the versatility of our platform. We validated that our impact technology can recruit and activate T cells against cancer.

And the single sending dose portion of the M. 113 V trial, we demonstrated safety and biomarkers, indicating target engagement.

The goals of the ongoing multiple ascending dose portion are to demonstrate anti viral activity, including one reducing the reservoir in blood and to delaying the viral rebound.

As we round out the clinical pipeline I will transition to highlighting further diversity to any of our platform.

We validated that are impacted analogy can recruit and activate T cells against cancer.

David: We are using the same T cell activation approach to target HIV and chronic HPV. Today, I will share the third platform, called Intide, which has a different goal of turning off inflammation and is intended to treat autoimmune and inflammatory diseases. The current standards of care for ANI are systemic immune suppression, which can lead to systemic toxicity. Our vision for the future is down modulation of the immune system focused only on the organ or tissue which is under immune attack. As part of our cancer peptide discovery work, we have been mapping the normal human peptidase.

We are using the same T cell activation approach to target HIV and chronic HBV.

Today, I will share the third platform called <unk>, which has a different goal of turning off inflammation.

And is intended to treat autoimmune and inflammatory diseases.

The current standards of care for Eni or systemic immune suppression, which can lead to systemic toxicity.

Our vision for the future is down modulation of the immune system focus only in the Oregon or tissue, which is under in your an attack.

As part of our cancer peptide discovery work, we have been mapping the normal human peptide them.

David: Therefore, when we want to develop a program to down-modulate the immune attack in a specific organ, we have a large pre-existing library of peptides that we know are tissue-specific. On slide 20, you can see our mTi molecule. The blue targeting end tethers the MTI to the target tissue. The purple effector end is a PD-1 agonist that presses on the PD-1 break to turn off the T-scan.

Therefore, when we want to develop a program to down modulate the immune attack in a specific organ, we have a large pre existing library of peptides that we know our tissue specific.

On slide 20, you can see our anti molecule.

The blue targeting and tethers the M tie to the target tissue.

The triple a sector and is a PD, one agonist, which pressures on the PD one break to turn off the T cell.

David: There is also an FC fusion, which prolongs the half-life and enables less frequent dosing. Our first application is for patients with type 1 diabetes, which remains a large unmet need. Type 1 diabetes results when autoreactive P cells kill pancreatic beta cells, which normally secrete insulin, to protect the pancreatic beta cells. We designed an MCI that binds to a peptide from the pre-proinsulin protein, which is only expressed in beta cells.

There was also an FC fusion, which prolongs the half life and enables less frequent dosing.

Our first application is for patients with type one diabetes, which remains a large unmet need.

Type one diabetes results when auto reactive T cells kill pancreatic beta cells, which normally secrete insulin.

To protect the pancreatic beta cells, we designed in and tie that binds to a peptide from the pre pro insulin protein, which is only expressed in beta cells.

David: The PD-1 agonist effector end will turn off these autoreactive T cells. As seen in the data on the right, we see protection against autoreactive T cell killing only when using an EMPI that tethers to the beta. Our second candidate is for skin inflammatory diseases, including atopic dermatitis and psoriasis, among others. We designed an EMPI that binds specifically to a target that is only expressed on antigen-presenting cells in the skin. In a T-cell stimulation assay, we observed inhibition of T-cells only for an MTI that tethers to the antigen-presenting cell.

PD, one agonist effector and will turn off these auto reactive T cells.

As seen in the data on the right, we see protection against auto reactive T cell killing.

Only when using an MRI that tethers to the beta cells.

Our second candidate is the skin inflammatory diseases, including atopic dermatitis and psoriasis among others.

We designed in and tie that binds specifically to a target that is only expressed on antigen presenting cells in the skin.

And a T cell stimulation assay, we observed inhibition of T cells only for an M tie that tethers to the antigen presenting cell.

David: This candidate has another exciting feature; it is universal and not HLA-restricted. This is an example of how our technology can be broadened to all populations. This is certainly an exciting and productive period at Immunocore as we continue to pioneer TCR bispecifics for cancer, for infectious diseases, and now for autoimmune diseases. I will hand over to Brian. Thank you, David. Good morning, everyone.

This candidate has another exciting feature it is universal and not HLA restricted.

This is an example of how our technology can be broadened to all populations.

This is certainly an exciting and productive period I Didnt unit car as we continue to pioneer TCR bi specifics for cancer for infectious diseases and now for autoimmune diseases.

I'll hand over to Brian.

Thank you David.

Good morning, everyone.

Brian: Earlier today, we released our financial results for the fourth quarter and year ended 2023. Please refer to the press release and our latest SEC filing on Form 10-K for our full financial results. This is the first time that we have reported financials as a U.S. domestic filer, and the comparisons I will discuss are now all in U.S. GAAP. The accounting difference between U.S. GAAP and IFRS is not significant—less than $1 million net in each of the last three years.

Earlier today, we released our financial results for the fourth quarter and year ended 2023.

Refer to the press release, and our latest SEC filing on Form 10-K for our full financial results.

This is the first time that we report financials as U S domestic filer and the comparisons I will discuss are now all in U S. GAAP.

The accounting difference between U S GAAP and I FRS is not significant less than $1 million net at each of the last three years.

Brian: I will now share some of the key highlights. In our second year of launch, 2023 has been an impressive year of KimTrack sales, with net revenues growing to $67.6 million in Q4 from $62.6 million in Q3, primarily driven by 13% growth in the United States. Total sales for the year, at $238 million, were an increase of 70% over 2022.

I will now share some of the key highlights.

In our second year of launch 2023 has been an impressive year of contract sales.

With net revenues growing to $67 6 million in Q4 from $62 6 million in Q3, primarily driven by the 13% growth in the United States.

Total sales for the year of 238 million or an increase of 70% over 2022.

Brian: As Ralph mentioned, we continue to make best estimate revenue recognition assumptions and associated accruals for France until we achieve a final price agreement. In line with the expansion of our portfolio, we have seen R&D and SG&A expenses increase marginally throughout 2023, with a net loss for the year of $55 million, or $1.13 per share. We expect expenses to marginally increase in 2024 as clinical development for late-stage PRAME and ChemTrac programs accelerate. On slide 25, you see our net cash position increased to $443 million in 2023. Additionally, in February, we completed a 6-year, $402 million convertible bond offering with a 2.5% interest rate and net proceeds of $389 million. We intend to use $50 million of these proceeds to repay our Pharmacon loan in November, which has a rate of 9.75%. Taken together, after this financing, we estimate a pro forma cash position of $782 million. Our ChemTrack sales and current cash put us in an excellent position to transform outcomes for patients by accelerating this portfolio with multiple clinical opportunities across three therapeutic areas. I will now pass back to Beazer.

As Ralph mentioned, we continue to make best estimate revenue recognition recognition assumptions and associated accruals for France until we achieve final price agreement.

In line with the expansion of our portfolio, we have seen R&D and SG&A expenses increased marginally throughout 2023.

With a net loss for the year of $55 million or $1 13 per share.

We expect expenses to marginally increase in 2024.

Clinical development for late stage frame and Kim track programs accelerated.

On Slide 25, you see our net cash position increased to $443 million in 2023.

Additionally in February we completed a six year 402 million convertible bond offering with a two 5% interest rate and net proceeds of $389 million.

We intend to use $50 million of these proceeds to repay our pharma come on in November which has a rate of 975%.

Taken together after this financing we estimate our pro forma cash position of $782 million.

Our contract sales and current cash put us in an excellent position to transform outcomes for patients by accelerating this portfolio with multiple clinical opportunities across three therapeutic areas.

I will now pass back to be easier.

Yeah.

Dr. Paneja Jalal: Thank you, Brian, David, and Narell. As you have seen, we have multiple data readouts and study starts planned for the remainder of 2024. It will be a very busy year.

Thank you, Brian David and no.

At all.

As you have seen we have multiple data readouts and study starts planned for the remainder of 'twenty 'twenty four.

It will be a very busy year.

Operator: Reflecting now on the pipeline, Immunocore has an industry-leading bi-specific TCR pipeline that now spans three therapeutic areas and reflects the large potential of our IMTAX platform. In the last five years, Immunocore has evolved from a research organization to a revenue-generating, sustainable company. We look forward with excitement to the next five years, when we will maximize the value of the contract, expect to launch our frame targeted therapy, and advance our other programs in oncology, infectious disease, and autoimmune disease. Now the full team will be happy to answer questions. Thank you. 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. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key.

Reflecting now on the pipeline I mean of course has an industry leading by specific TCR pipeline.

Now spans three therapeutic areas and it reflects the large potential of our impacts platform.

In the last five years I mean of course has evolved from a research organization to a revenue generating sustainable company.

We look forward with excitement to the next five years, when we will maximize the value of contract.

Expect to launch our crane targeted therapy and advance our other programs in oncology infectious disease and autoimmune disease now the full team will be happy to answer questions. Thank you.

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

A confirmation tone will indicate your line is in the question queue you.

You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, we ask that you. Please let me yourself to one question.

Michael Yee: We ask that you please limit yourself to one question. Our first question comes from the line of Michael Yee with Jefferies. Please proceed with your question. Hey guys, thanks. Good morning.

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

Hey, guys. Thanks, good morning.

David: Great update. I had a question about the contract. The Advanced Melanoma Study, which has a readout at the end of the year. And I wanted to understand, as part of this Phase 2, 3, design, how you think about the primary endpoint and what you would expect the scenarios to be appreciating that. I guess you could sort of go to the Phase 3, where there could be trends, and you'd still go to the Phase 3. Tell me about the types of different outcomes there at the end of the year, given the Phase 2, 3 design. Thank you. Thank you, Michael, for the question. David, do you want to take this one?

Update I had a question on the kin track.

Advanced melanoma study, which has a readout at the end of the year and I wanted to understand as part of this phase two three design.

How do you think about the primary endpoint.

And what you would expect the scenarios to be appreciating that you I guess you could sort of go to the phase three are there could be trends and you would still go to the phase III tell me about the types of different outcomes. There at the end of the year given the phase II three design. Thank you.

Thank you Michael a question David do you want to take this one.

Michael Thank you very much the phase two part of the study has dual primary end points of C. T D N a N over it so overall survival at the end of the year. The E. T DNA will be mature and be survival will be directional and we believe it will it be able to inform us on a couple of key questions. Michael one is can we drop one.

David: Michael, thank you very much. The phase two part of the study has dual primary endpoints of ctDNA and overall survival. At the end of the year, ctDNA will be mature, and survival will be directional. And we believe it will be able to inform us on a couple key questions. One is, can we drop one of the arms?

David: Do we really need to include PD-1 or not? The second question we're going to ask is, can we resize the study? Are our assumptions correct?

The arms do we really need to include a PD one.

The second question, we're going to ask is can we resize the study.

As our R&R assumption or our assumption is correct. So I think at the end of the year, we will have a topline of C. T. DNA overall survival trend and what the next steps are in the phase III.

David: So I think at the end of the year, we'll have a top line for ctDNA, an overall survival trend, and what the next steps are in phase three. Thank you. Our next question comes from the line of Jessica Fye with JP Morgan. Please proceed with your question. I was hoping you could walk through in a little more detail the various frame updates we can expect throughout the year, with details like the number of additional patients we should expect for cutaneous melanoma, patient, for ovarian cancer, your range of patients for how many, and when should we expect any update from the end of? Great, thank you, Jeff. David, do you want to take this one?

Yeah.

Thank you. Our next question comes from the line of Jessica Fye with J P. Morgan. Please proceed with your question.

Hey, guys. Good morning. Thanks for taking my question I was hoping you could walk through in a little more detail there.

Claim updates we can expect throughout the year with details like the number of additional patients we should expect for cutaneous melanoma, how many patients will see for ovarian and maybe a range of patients for how many well see in lung and when should we expect any update from the endometrial cohort. Thank you.

Thank you Jess David you want to take this one.

David: Yes, Jeff. We haven't commented on the numbers, but I'll walk you through the different readouts. For cutaneous melanoma, which matured the fastest, we'll be presenting the data that supported our decision to move to phase three, the data that we shared with the FDA and with KOLs, and we can talk more about that if you'd like. For ovarian, we're still enrolling patients there. That was when I was maturing.

Yes, Jeff So we haven't commented on numbers, but I'll walk through the different readouts for cutaneous melanoma, which matured the fastest will be presenting that data that supported our decision to move to phase III data that we shared with the F. D. A.

With Kols and we can talk more about that if you if you'd like for ovarian we're still enrolling patients. There that was maturing I thought that enrollment was a little bit behind melanoma were still enrolling ovarian but that data will be available in the second quarter with light. It has been a little bit different we're enrolling all comers with ovarian and with nowhere.

David: That enrollment was a little bit behind melanoma. We're still enrolling ovarian cancer, but that data will be available in the second quarter. With lung cancer, it has been a little bit different.

David: We're enrolling all comers with ovarian and with melanoma with lung. We have taken a methodical approach to focus initially on subsets where we think we'll see signals before expanding more broadly. For both melanoma and ovarian and lung cancer, in addition to monotherapy, we have combinations.

With lung we have taken a methodical approach to focus initially on subsets, where we think we'll see signals before it before expanding more broadly.

For both melanoma and ovarian and lung in addition to monotherapy, we have combinations for melanoma PD one combinations.

David: For melanoma, it's PD-1 combinations. For ovarian and lung cancer, it's going to be a chemotherapy combination. Thank you. Our next question comes from the line of Tyler Van Buren with TD Cowen.

Our ovarian and lung, it's going to be the chemotherapy combinations.

Okay.

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

Tyler Van Buren: Please proceed with your question. Hey guys, thanks for taking the question and congrats on another great ChemTrac quarter. Just to follow up on the second quarter PRAME melanoma update, if I'm not mistaken, there was only one cutaneous melanoma patient ongoing as of the update during the second quarter, 23 earnings. So should we expect more cutaneous monotherapy patients with the second quarter update or not? And regarding the PD-1 combo data, how heavily pretreated are these patients so we can understand what the bar should be that we should compare it to? Thank you, Taylor. Another one for David.

Hey, guys. Thanks for taking the question and congrats on another great quarter just.

Just a follow up on the second quarter praying melanoma update if I'm not mistaken there was only one cutaneous melanoma patient ongoing as of the update during the second quarter 23 earnings. So should we expect more cutaneous monotherapy patients with the second quarter update or not.

And regarding the PD, one combo data how heavily pretreated or are these patients. So we can understand what the bar should be that we should compare to.

Thank you Taylor and another one for David Yeah. So the first question.

David: Yes. So for the first question at the update last year, we just shared the update with the original asthma patient. So we certainly will have more cutaneous melanoma patients, and it will be sufficient to inform and provide reasons to leave for the phase three trial. With regard to the second question, which I missed, which tumor type you have. Yeah, for melanoma with the PD-1 combination data, how heavily pretreated will they be so we can understand what the bars should be? Yes, Tyler, I can. I can address that. So it's a mixture.

At the update last year, we just shared the update of the original asthma patient. So we certainly will have more cutaneous melanoma patients and it will be sufficient to inform it.

And provide reasons believe for the phase III trial with regard to the second question, which I missed which tumor you were a potent.

Yeah for melanoma PD, one combination data how heavily pretreated will they be used by week or something with a bar should be yes.

Yeah.

Tyler I can I can address that so it's a mixture so they're worse than patients because the Pembroke is indicated they could be pimco naive, but many of them were previously exposed to is the mixed population because the primary endpoint is safety and feasibility.

David: So there were some patients because the Pembroke trial indicated they could be Pembroke naive, but many of them were previously exposed. So it's a mixed population because the primary endpoint is just safety and feasibility. And that was Mohammed Al-Syamal.

And that was not met our CMO.

Eric Schmidt: Thank you. Our next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please proceed with your, Now, thanks for taking my question and congrats on the quarter. Maybe one on the chem track in the phase two slash three relapse refractory melanoma study and the phase to read out toward year end. I think you've commented that if the data are favorable from the Phase 2 portion, it could support a compendia listing. How should we think about a compendia listing with an endpoint?

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

Thanks for taking my question and congrats on the quarter, maybe one on Kim track in the phase two slash three relapsed refractory melanoma study and the phase two readout toward year end I think you've commented that you.

If the data are favorable from the phase II portion they could support a compendium listing how should we think about a compendium listing with an endpoint.

David: Survival Driven as opposed to Responsive. David, do you want to take it? Eric, very good question. So this is something that we'll have to decide on in a data-dependent fashion. The survival data will mature in 2025, and we will typically, what happens, Eric, is that you submit that, you write a paper or a presentation, you submit that to NCCN. So we will try and submit it, and it's up to NCCN to decide whether or not to accept it. The benefit, of course, is that we already have a therapy which has shown a survival benefit, albeit in a different type of melanoma.

Survival, driven as opposed to response rate right.

David you want to do.

Eric very good question.

So this is something that will have to decide.

Decided on a data dependent fashion.

Survival data will mature in 2025, and we will typically what happens Eric that you submit that you write a paper presentation, you submit that to M. D C and so we will try and submit it and it's up to N C. T N to decide whether or not to accept that the benefit of course since we already have a therapy, which is true.

On a survival benefit, albeit in a different type of melanoma.

David: Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Please proceed with your question. Thanks for taking our question. This is Paul. I'm for Michael.

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

Hi, Thanks for taking my question. This is Paul on for Michael a minor also on frame. So maybe for David you know what is your current thinking on the frame registrational opportunity in late like cutaneous melanoma is it still a focus area given your initiation of the frontline phase III and if so how do you think about response benchmarks does there'll be since accelerated approval.

Paul: My interests are also in PRAME, so maybe for David. What is your current thinking on the PRAME registrational opportunity in late-line cutaneous melanoma? Is this still a focus area given your initiation of the front line phase three? And if so, what do you think about response benchmarks?

David: Does the recent accelerated approval for MTAG-B impact your view on the setting? And then just a quick follow-up on PRAME in lung cancer. Can you expand on which particular subsets are in focus and overall strategy here? So maybe, David, thank you, Michael, first for the question. Maybe David would start and then Mohamed, go ahead.

Or and tabby impact your view on the setting and then just a quick follow up on on Prem and long can you expand on which particular subsets arent focus and overall strategy here. Thank you.

So maybe David Thank you Michael first of all the question, maybe David to start and then the Mohammed right Mike.

David: Michael, sorry, Paul, yes. So in terms of PRAME, we as a small company have to focus. And so what we have decided is to focus on where we believe is both the best opportunity from a technical point of view, but also which is the biggest opportunity. And so for PRAME, we're focused on the first line.

Michael Thanks, sorry, Paul Yes, so in terms of the frame we as a small company has to focus and so what we have decided to focus where we believe is both the our best opportunity from a technical point of view, but also which is the largest opportunity and so if we're playing we're focused on first line in the late line setting where the.

David: In the late line setting where the PILS was recently approved, that's where we have ChemTrac as an opportunity. And that trial is going well. And that trial has a survival endpoint, which will lead to full approval, whereas the recent PILS was an accelerated approval. With regard to the lung question, I'm happy to do that. So with lung cancer, we know it's a very heterogeneous disease, and there are distinct molecular subsets based on well-known and well-described subsets.

Telcel recently, that's where we have Kim track and an opportunity and that trial is it pulling well in that trial has a survival endpoint, which will lead to a full approval, whereas the recent calls was an accelerated approval.

With regards to the lung question, but do you want anything what it takes to do that so with with lung. We know, it's a very heterogeneous disease and there's distinct molecular subsets based on well known and well described subset are the cohorts that David alluded to that we're exploring our sort of run along those run along those line.

Mohamed: The the cohorts that David alluded to that we're exploring are sort of run along those lines. Thank you. Our next questions come from the line of Greg Savanovich with Mizuho.

Yeah.

Thank you our next questions come from the line of Greg savanna matched with Mizuho. Please proceed with your question.

Avantika: Please proceed with your question. Hi, this is Avantika speaking for Gregg. Congratulations on the quarter. I just had a question on KimTrack. It appeared that the ex-US sales were a little bit flat, I would say. Is there a reason for this?

Hi, This is for Greg Congrats on the quarter I just had a question on contract. It appeared that the ex U S sales were a little bit flat I would say is there a reason for that is and how do you intend to keep growing.

Ralf: And how do you intend to keep growing this? And how do you also intend, or how much more growth do you see in the US? Thank you. Thank you, Avantika. Lausi, do you want to take this one?

How do you also intend or how much more growth do you see in the U S. Thank you.

Thank you Evan.

Ralf: Avantika, thank you for your question. So, look, we've had a very successful set of years, a couple of years in Europe where we launched in Germany, France, notably, but as well as Italy and six other countries. So, we're really at this phase where we've established chemtrails as standard of care, and we are well penetrated, so we do see a relatively flat future with some of the launches incrementally adding to the growth there. Now, the primary driver of growth will be the United States, and that will be driven really mainly by us continuing to penetrate into the community and identifying patients earlier. And as you know, in Europe, it's about the, you know, country by country for pricing.

Well I also want to take this one I don't think I. Thank you for your question. So.

Look we've had a very successful set of years, a couple of years and in Europe, where we've launched in Germany, France significantly, but as well as Italy and six other countries. So we're really in this phase where we've established can try get standard of care and we are well penetrated so we do see a relatively flat fuel.

Whereas some of the launches incrementally adding to the growth there now.

Mary driver of growth will be the United States and that will be driven really mainly by us continuing to penetrate into the community and identifying patients earlier.

And as you know you know in Europe, it's about that you know.

Country by country for pricing and so that's.

Ralf: And so that's what we're continuing that. Thank you. Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question. Thank you. Thanks for taking the time. Just as we think about revenues this quarter, what drove the growth in..., www.

Sure.

Continuing that.

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

Great. Thank you thanks for taking my questions and congratulations on the quarter I'm, just just as we think about.

Revenues this quarter kind of what drove the growth in.

Peter Lawson: ImmunocoreHldg.com any guidance. Great, Peter. Great question, Rolf.

The U S business any one time as we should think about it.

Any guidance around how we should be thinking about.

Yeah.

Great Peter Great question Ross.

Ralf: So, Peter, we had a great 13% quarter-over-quarter growth in the U.S. The main driver for that, if you recall, at the beginning of the year, we said we were going to be focusing on the community and community penetration, and that's what we did. Now, the majority of our scripts are coming from the community, and that's what's driving, really, the main part of our growth.

So Peter we.

We had a great 13% quarter over quarter growth in the U S.

Main drivers to that if you recall at the beginning of the year, we said, we're going to be focusing on a community by community penetration.

And that's what we did now the majority of our scripts are coming from the community.

That's what's driving really the main part of our growth. We're also seeing duration of therapy be sustained with what physicians are going to be a progression. So what we expect in 'twenty 'twenty four is the growth to incrementally continuing to the U S.

Ralf: We're also seeing duration of therapy being sustained, with physician treatment being on progression. So, what we expect in 2024 is the growth to incrementally continue into the U.S. And, you know, beyond 2024, in the midterm, we're expecting, as David has mentioned, time-medium study data, as well as, in the long term, the ATOM trial, which we're very excited about. Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question. Hi, this is Charlie on behalf of Jack.

You know beyond 'twenty 'twenty four and in the midterm, we're expecting the as David has mentioned.

Study data as well as in the long term the anthem trial, which we're very excited about.

Okay.

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

Hi, This is Charlie on for Jack I was just wondering if you know for the ovarian.

Charlie: I was just wondering if, you know, for the ovarian cancer in the PRAME franchise, would you be able to give us a little more color in terms of the size of the data set you're expecting as well as the duration of follow-up and what you would consider the bar for success there? All right, Jack, thank you. David, you want to take this question? Yeah, Charlie, with regard to size, we haven't been commenting on the number of patients. But what we have said is that we will show data that it's efficient in order to inform the level of activity and the duration of follow-up, which we believe will also be sufficient in terms of the bar for success. We're looking at answering two questions, which is that traditionally, what we do in drug development is the drug active, and does that clinical activity support?

The frame franchise would you be able to give us a little more color in terms of the size of the dataset, you're expecting as well as a duration of follow up and what you would consider the bar for success there.

Right.

Thank you David do you want to take this action.

Yeah, Charlie the with regard to size as we haven't been commenting on number of patients, but what we have said is that we will show data that is sufficient in order to inform the level of activity and the duration of follow up we believe will also be.

Sufficient in terms of the bar for success and we're looking at so I'm answering two questions, which is traditionally what we doing drug development is the drug active and does that clinical activities support Registrational trials. So we know the drug is active and then here in terms of clinical activity will be looking at partial responses durable tumor.

Charlie: Registration or trial so we know the drug is active, and then here in terms of clinical activity, we'll be looking at partial responses durable tumor reduction PFS Disease control, and, of course, CTD and a reduction which is emerging as a consistent theme for our platform Thank you. Our next question comes from the line of Mukherjee with BTIG. Please proceed with your, Hey, thanks for taking our question. This is Jidon for Justin.

Reduction PFS.

These control and of course C. P D G&A reduction, which is emerging as a consistent theme for our platform.

Thank you. Our next question comes from the line of Jeet Mukherjee with BTG. Please proceed with your question.

Hey, Thanks for taking our question. This is jeet on for Justin.

David: I was hoping you could just help us think about the efficacy bar for relapse-free survival in the adjuvant setting and just any thoughts around the neoadjuvant setting as well for uveal melanoma. Thanks. Right, Jeff, David, do you want to take this one?

Hoping you could just help us think about the efficacy bar for relapse free survival for the adjuvant setting and just any thoughts around the neo adjuvant setting as well for Uveal melanoma. Thanks.

Right, Geoff and David do you want to take this one and maybe you can comment as well.

David: And maybe you could comment as well? Yeah, I'll focus on the neoadjuvant first. You know, interestingly, in the original trial, when we looked back, we did have a couple of patients with residual melanoma in the eye. And interestingly, when we looked at those lesions, there was actually a reduction in those tumor lesions. So I think neoadjuvant therapy is an exploratory program, and we have a couple ESRs with regard to that. In terms of your first question, which was, what is the bar for success in terms of relapse-free survival, what would the control arm be? This is a high-risk population. Yeah, and I think Mohamed can comment on that.

Yeah, I'll focus on the Neo adjuvant first stab.

Interestingly in the original trial when we look back we did have a couple of patients with residual melanoma.

In the eye and interestingly when we looked at those lesions there was actually a reduction in those tumor lesions. So I think neo adjuvant is an exploratory <unk>.

Program and we have a couple of E. S ours with regard to that in terms of your first question, which was the what is the bar for success in terms of relapse free survival.

What the control arm B. This is a high risk population.

And I think Mike can comment on that yes, sure I'm happy to comment so it really does.

David: Yeah, sure. I'm happy to comment. So, really, you know, the way to think about this is that there is no standard in the adjuvant setting, and so the bar, you know, there's no established bar.

Way to think about this is that there is no standard in the adjuvant setting and so the bar you know Theres no Theres no established firewall. He knows that the median time to relapse in this high risk population, which is the target population is about three years and so the bar is that we have to improve above that above that so this is the way to conduct a trial in the adjuvant setting which is a randomized trial.

Mohamed: What we know is that the median time to relapse in this high-risk population, which is the target population, is about three years, and so the bar is that we have to improve on that. So, this is the way to conduct a trial in the adjuvant setting, which is a randomized trial that's global that focuses on the high-risk population. OK. Thank you. Our next question comes from the line of Patrick Truccio with HC Wainwright.

Global that focuses on the high risk population.

Okay.

Thank you. Our next question comes from the line of Patrick Trujillo with H C. Wainwright. Please proceed with your question.

Patrick Truccio: Please proceed with your question. Thanks. Good morning, and congratulations on all the progress. I have a follow-up on the PRAME Phase III program. I'm wondering if you can discuss in more detail the strategy around pursuing first-line treatment, as well as the design that includes that combination with NEVO. How should we think about the contribution of PRAME to this regimen and understand the studies expected to randomize the first patient this quarter? When do you anticipate initial data, like ctDNA data, to emerge?

Thanks, Good morning, and congrats on all the progress I have a follow up on the cream phase III program I'm wondering if you can discuss in more detail the strategy around pursuing first line treatment as long as the design that includes the combination with me, though how should we think about contribution of cranes. This regimen in understanding. This study is expected to randomize the first.

Patient this quarter when do you anticipate initial data like C. T DNA data to emerge and what read through should we anticipate from that data to a potential for the program success on the primary endpoint of PFS.

David: And what read-through should we anticipate from that data regarding the potential for the program's success on the primary endpoint of PFS? Patrick, thank you for the question. I think David and Mohammed can answer that.

Patrick you Patrick and thank you for the question I think David and Mohammed.

David: Yeah, so Patrick, I'll try to answer a couple of your questions. I hope I can answer them all. But in terms of the phase three frame first-line trial, I think that's what your question was. There were, of course, multiple data points that led to that. The monotherapy activity of F106C, which we'll share, the ability to combine with anti-TD1s, and then knowledge for our platform, and it's true with immunotherapies in general, you always see higher activity as you move from late to first-line. In fact, with ctDNA clearance and ChemTrac, we see a tripling of clearance as we go from second-line to first-line. In terms of the design and the contribution of components, the design is PRAME plus Novolumab versus Novolumab.

Patrick I'll try to answer a couple of your questions I hope I get them, all but in terms of the phase three.

I'm flying trial I think that's what your question was of course multiple data points that led to that.

The monotherapy activity of F. When it's like C, which we'll share it.

<unk> to combine with anti PD ones, and then knowledge for our platform and it's true with Immunotherapies in general that you always see higher activity as you move from late into the first line in fact with C. T DNA clearance and contract we'd see a tripling of clear. It says we'd go from second line to first line in terms of the design and the contribution of components to that.

And is praying plus the volume add versus Napoleon app. So that already has built in the contribution of components because we have the frame on top up in the volume at now there will be a minority of patients in the control arm, who do get up to a lag.

David: So that already has built in the contribution of components because we have PRAME on top of Novolumab. Now, there will be a minority of patients in the control arm who do get Opduralag, and so we'll be able to draw a point estimate that most of the patients, in comparison to Opduralag, will have received NEBO monotherapy. So we'll have the contribution of components there, and the primary endpoint is progression-free survival, which is globally accepted for approval for regulatory approval. The secondary endpoint is overall survival. We do have an exploratory endpoint of ctDNA, but that won't be available until the trial is over. Thank you. Our next question comes from the line of Gil Bloom with Needham. Please proceed with your question. Good morning, and thanks for, Um, maybe a quick one, your new PWill Asset and MCR-CC. So, generally, CRCC is in the mutant desert. Could that be a potential issue for agents of this type? I mean, we've seen a lot of activity on TABN.

But and so we'll be able to draw a point that some of it but most of the patients in comparisons I feel like that most of the patients will have received <unk> monotherapy. So won't have contribution of components there and the primary endpoint is progression free survival, which is globally accepted for approval for regulatory approval the secondary.

This overall survival, we do have an exploratory endpoint of C. P DNA, but that won't be available until the trial is over.

Thank you. Our next question comes from the line of Gil Blum with Needham. Please proceed with your question.

Good morning, and thanks for squeezing me in.

Maybe a quick one on your new P will asset in CRC. So you know generally scarcity then immune desert good that'd be a potential issue for agents of this type I mean, we've seen a lot of activity for tap and then.

Gail: Premacid, and more T-cell infiltrated tumors. Thank you. Yeah, thank you, Gail, for this question. I'll pass it on to Mohamed, but I just want to remind you that uvein melanoma is a completely cold tumor, as cold as it gets. So that's, I think, where our platform... Would you like to talk a little bit, Mohamed, about that? Yes, This is part of the reason why we're so excited about the PEEWP program and our mechanism, which is very distinct from checkpoints, where we don't need pre-existing immunity or infiltration by the immune system into the tumor. We, you know, what we've shown with Tebby, as Behija was alluding to, is that we just need functional T-cells in the periphery, and our mechanism drives T-cells into a non-inflamed or immune desert.

Frame asset in <unk> T cell infiltrated tumors.

Yeah.

Yeah, I think your answer for this question I'll pass it onto to Mohammed that I, just want to remind you that today.

Uveal melanoma is a complete called tumor as cold as it gets so that that's I think where our platform you want to talk little bit about that yeah.

That's this is part of the reason why we're so excited about the pivotal program and our mechanism, which is very distinct from checkpoints, where we don't need preexisting immunity or infiltration by by the immune system into the tumor. We you know what we've shown with <unk>. He said was alluding to is that we just need functional T cells in the periphery and our mechanism drives T cells into.

Non inflamed or immune desert. So this is one of the reasons why we're excited about this program and its potential application in CRC.

Mohamed: So this is one of the reasons why we're excited about this program and its potential application in CRC. And then we'll let the data tell us. Thank you. Our next question comes from the line of Noreen Quibria with Capital One Securities. Please proceed with your question. Hi, good morning, congratulations on the quarter, and thanks for taking my question.

And we'll let the data tell us.

Thank you. Our next question comes from the line of Noreen quicker with capital One Securities. Please proceed with your question.

Hi, good morning, Congrats on a quarter and thanks for taking my question. So am I I guess, just a follow up on they can track them basically.

Maureen: So, I guess just to follow up on the ChemTrac Phase 2, 3 TebAM study, you know, obviously you're going to be looking at the ctDNA and the trends with the OS. I'm just curious, what kind of reduction in ctDNA do you expect in this setting, you know, sort of to help you inform the decision to drop one arm? You know, what kind of delta are you looking at?

In study.

You know.

You are going to be looking at the C. P. D N a N and M. The trends with the O S.

I'm, just curious what kind of reduction in P. T D. N. A do you expect them in this setting.

Setting you know sort of to help you informed the decision to drop one arm you know how big of a delta are you looking at them and I was going to be comparing you know between the two arms.

David: And are you going to be comparing, you know, between the two arms, or is it just a baseline from the specific arm? Great. Maureen, thank you very much. David, do you want to take this one? Yeah, so we'll be looking... So we have three arms, just as a reminder.

Flying from the specific on.

Great. Thank.

Thank you very much David do you want to take yeah, well. So we'll be looking at so we have three arms just as a reminder, we have the bandwidth as monotherapy dependents, plus campbellism mapping and of course the control arm.

David: We have the ventibus monotherapy, the ventibus plus cumberlizumab, and then, of course, the control arm. And the dual endpoints are ctDNA and survival. In terms of ctDNA, we believe it gives us information, but since it's still exploratory in cutaneous melanoma, we will rely on survival as well. And although survival will not be fully mature, we have done some simulations showing that we will have sufficient power to see trends in order to drop one of the arms.

And the primary the dual endpoints are seeking in and survival in terms of C. T DNA.

We believe it's Directionally gives us information, but since it's still exploratory in cutaneous melanoma, we will rely on survival as well and although the survival will not be fully mature we have done some simulations showing that we will have sufficient power to see trends in order to draw them to drop.

David: The size is about 40 patients per arm, and so we think we have enough power in order to make the decision integrating ctDNA and survival. Thank you. Our next question comes from the line of Jeffrey Hung with Morgan Stanley.

One of the arms the size is about 40 patients per arm.

So you know.

We think we have enough power in order to make that decision, taking integrating C T DNA and survival.

Okay.

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

Michael Riad: Please proceed with your question. Could you talk a little bit more about CT DNA's predictive power on LS and advanced cutaneous versus uveal melanoma? How far in the treatment course do you need to go to have confidence in its predictive power? And does that power get stronger as you move into earlier lines?

Hi, This is Michael Rehaut on for Jeff hung. Thank you for taking my question could you talk a little bit more about C. T D nice predictive power and.

In advanced cutaneous versus Uveal melanoma, how far in the treatment of course do you need to go to have confidence in its predictive power and does that power gets stronger as you move earlier and Terry your lines. Thank you.

David: Thank you. Thank you, Michael. David, do you want to take it? Yeah, Michael.

Thank you Michael maybe you want to take it yeah I'm, Michael So B currently association with survival, we have validated in Uveal melanoma in two independent trials. So when it comes to Uveal melanoma teaching in a we have really strong confidence with cutaneous melanoma.

David: So the association with survival, we have validated in uveal melanoma in two independent trials. So when it comes to uveal melanoma ctDNA, we have really strong confidence. With cutaneous melanoma, we have emerging confidence, but we, of course, don't have randomized trials and we don't have long-term survival.

It's we have emerging confidence, but we of course don't have randomized trials and we don't have long term survival. So we will be looking both at C. T. DNA directionally as an early potential surrogate and we'll be looking at survival in parallel we hope that this trial will begin to set up the associations that we have seen it.

David: So we will be looking both at ctDNA directionally as an early potential surrogate, and we'll be looking at survival in parallel. We hope that this trial will begin to set up the associations that we have seen in uveal and cutaneous melanoma, but we acknowledge that we'll need to see both ctDNA and survival and integrate both of those at this early time. Thank you. Our next question comes from the line of Ahu Demir with Lattenberg. Please proceed with your question. Good morning.

<unk> in cutaneous melanoma, but we acknowledge that we'll need to see both C. P DNA and survival and integrate both of those at this early time.

Thank you. Our next question comes from the line of AHU Demir with Ladenburg. Please proceed with your question.

Ahu Demir: Thank you so much for taking my questions and congrats on the quarter. Two questions from us. The first one is on the pre-melanoma VDAT in the second quarter. In terms of patient follow-up, could you give us a sense of the majority of patients and how long they were followed up for? And the second question I have is about expectations for the HIV math study; what does success look like? Thank you, Ahu, David, and maybe Mohamed as well. Yeah, in terms of the PRAME melanoma, I do think we have sufficient follow-up in order to show durability. I don't have the exact follow-up with me right now, but I would say, Ahu, that it's going to be sufficient in order to interpret the data. And that's because, and the reason I say that is because we enrolled a lot of those patients throughout 2023. In terms of HIV, it's a good question because no one has ever been able to show a reduction in the reservoir or a functional cure.

Good morning. Thank you so much for taking my questions and congrats on the quiet.

So from a first one is on the plane melanoma readouts in the second quarter.

In terms of the patient follow up could you give us a 10th of the majority of patients and how long they were part of that for.

And the second question I have is our expectation for the HIV Mad study, but the tech debt look like.

Thank you.

David and maybe Mohammed as well.

Yeah.

In terms of the frame melanoma I do think we have sufficient follow up in order to show durability I don't have the exact follow up with me right now, but I would say that it's it's gonna be sufficient in order to interpret the data.

And that's because and the reason I say, it's because we enrolled a lot of those patients throughout 2023 in terms of HIV. It's a good it's a good question because.

No one has ever been able to show a reduction in the reservoir or a function of alterra.

David: So for the reduction of the reservoir, we'll be looking in the blood to see whether we can reduce CD4 T-cells with HIV. And in terms of what success looks like in terms of that, I think we're going to have to generate the data, share it with the KOLs, and then we'll share that data, and we'll be able to interpret what success looks like. In terms of the delay of the viral rebound, that also is, you know, a very novel idea. No one has been able to show that, so I think we're going to have to look at the data, discuss with KOLs, and then we'll share the data. I think any sign of the delay in rebound that we can attribute biologically to the drug would be a success as an initial step in HIV treatment.

<unk> for the reduction of the reservoir will be looking in the blood to see whether we can reduce field.

CD four T cells with HIV and in terms of what success looks like that I think we're gonna have to generate the data sharing with the Kols and then we'll share that data and we'll be able to appropriate what success looks like in terms of a delay of the <unk>.

Viral rebound that also means it's you know a very novel.

No one has been able to show that so I think we're going to have to look at the data discussed with Kols and then we'll share that data I think any sign of delay and rebound that we can attribute biologically to the drug would be access as an initial step in HIV treatment.

David: Thank you. Our next question comes from the line of Rajan Sharma with Goldman Sachs. Please proceed with your question. Hi, just a quick one on KimTrack and just kind of thinking about how confident you are in maintaining pricing in a scenario where you do get these additional settings that you've talked about, significantly increase the number of patients on therapy, flagged 6,000 potential patients versus 1,000 currently, so be keen to understand how you see that playing out. Harrison, thank you. No, I think it would be a good problem to have, but go ahead, Gerald.

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

Hi, just a quick one on came track and just kind of thinking about how confident you are in maintaining pricing in a scenario where you do get these additional.

Things that you've talked to with Josie potentially significantly increase the number of patients on therapy. I think it's kind of you flagged 6000 potential patients. So that's the size and currently so it became to understand how you see that playing out.

Yeah.

Yeah all of a sudden thank you no I think it will be a good problem to have that product at all.

Rajan Sharma: I agree. Thank you for the question. So, the way we look at pricing is really the framework that we use is the value that it brings to patients and the value that it brings to society.

Thank you for the question so look the way we look at pricing.

Really the framework that we use is the value that it brings to patients value it brings to society.

Gerald: So, as Baheja said, it's a little bit early for us to comment on that. Once we see the data, we hope that this is bringing significant value, and therefore, price erosion would be minimal.

But he just said, it's a little bit early for us to comment on that so once we see the data we hope that this is bringing significant value.

The price erosion would be minimal.

Gerald: Thank you. There are no further questions at this time. I would now like to hand the call back over to Bahija Jallal for any closing remarks. Thank you very much. In closing, I would really like to express my really great gratitude to our patients, to our shareholders, and to the team. This past year has been a testament to our drive to bring Kintrac to patients, our innovation in bringing more novel targets and entering a new therapeutic area, and, as always, our commitment to patients by working with a sense of urgency. As we move forward into the next fiscal year, we remain steadfast in our mission to drive growth, create value, and deliver results.

Thank you there are no further questions at this time I would now like to hand, the call back over to but he said July for any closing remarks.

Thank you very much so in closing I would like to express my gratitude to our patients our shareholders and to the team.

Last year and has been a testament to our drive to bring contracts to patients our innovation into bringing more novel targets and entering a new therapeutic area and as always our commitment to patients by working with the sense of urgency.

And as we move forward into the next fiscal year, we remain steadfast in our mission to drive growth creates value and delivered results I would like to end this call by thanking all of you for your support thank you.

Bahija Jallal: I would like to end this call by thanking all of you for your support. Thank you. Thank you, that does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day, www.immunocorehldg.com www.immunocorehldg.com www.immunocorehldg.com www.immunocore

Thank you that does conclude today's teleconference. We appreciate your participation you may disconnect. Your lines at this time enjoy the rest of your day.

Yeah.

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