Immunocore Holdings PLC

NASDAQ:IMCR

Earnings Call Transcript 2022-Q2

[Operator]

Greetings. Welcome to the Immunocore Second Quarter 2022 Earnings Call. [Operator Instructions]. Please note, this conference is being recorded. I will now turn the conference over to your host, Clay Robertson, Head of Investor Relations. Thank you. You may begin.

[Clayton Robertson, Head, IR]

Thank you, Alex. Welcome to our Q2 earnings call. My name is Clayton Robertson, Head of Investor Relations at Immunocore. During today's call, we will be making forward-looking statements, including about financial projections, development activities, business strategy and the timing and impact of future events. Actual results could differ materially from those projected by these statements, which are based on management's views as of today, and subject to risks and uncertainties, including those noted in our most recent Form 20-F and in 6-K we filed with the SEC and in the earnings press release we issued this morning. You are cautioned not to place any undue reliance on these statements, and Immunocore disclaims any obligation to update them. We will also discuss certain non-IFRS measures on today's call, which are reconciled to the comparable IFRS measures in today's slides.

I'm now pleased to introduce Immunocore's Chief Executive Officer, Dr. Bahija Jallal.

[Bahija Jallal, CEO & Director]

Thank you, Clay. Good morning and good afternoon, everyone. We are very happy to be here and to share our strong Q2 results with you. With me today are Brian Di Donato, our Chief Financial Officer and Head of Strategy; Ralph Torbay, our Head of Commercial; and Dr. David Berman, our Head of R&D.

Our platform is an off-the-shelf soluble bispecific T cell receptor that was validated in a positive Phase III trial. This was the first ever T cell engager to show overall survival in solid tumors. In January, we received the approval of our first product, KIMMTRAK. With that, we have pioneered the new therapeutic modality, but most importantly, we have opened a new chapter in the treatment of cancer. Having launched the world's first TCR therapeutic and with an industry-leading pipeline and platform, the potential for what we can deliver for patients and investors is tremendous. Thanks to the dedication of our team, we have had exceptional first half of 2022, and we are delivering, and I could not be more proud of all of them.

So now let's focus on the second quarter of 2022. We have had an outstanding performance as we continue to execute across each of our objectives. Let's look at executing on commercial launch. I am so proud of the commercial team and the medical teams. They took the baton from R&D. And thanks to their efforts, we are off to a strong start.

Following the solid U.S. launch, we received a positive CHMP opinion in February with an EU approval that followed in April. The team was prepared and ready to go, and we immediately launched in Germany and in France. Actually, within the first 2 weeks post EU approval, we had transitioned all EAP patients in Germany to commercial supply. In June, KIMMTRAK was approved in the U.K., Australia and Canada, with commercial launches expected in 2023. I'm happy to report that we have generated over 45 million year-to-date in revenue from KIMMTRAK. But most importantly, we are reaching new patients who are facing this devastating disease. Ralph will give you more details in a few moments.

This would be an impressive list of achievements for any pharma company, but I think you'll agree with me that it is even more so for a biotech launching its first product. So moving now to the pipeline. We are executing against our plan to expand beyond uveal melanoma. At ASCO this year, we presented data in both cutaneous and uveal melanoma, and we are making progress in the plans for KIMMTRAK in cutaneous melanoma, and David will give you more details on the innovative trial design that he get the agreement with the FDA on.

We are on track, and we will be sharing PRAME Phase I data as an oral presentation at ESMO in September in Paris. And then in the fourth quarter, we are on track to presenting an update on MAGE-A4 data. Outside of oncology, we are advancing our infectious disease program in HIV and HBV. We recently dosed the first patient in Phase I HIV trial and presented early HBV data at EASL. David again will share more details on these exciting, but preliminary data.

And finally, last month, we solidified our financial runway through 2025 with $140 million PIPE transaction, which gives us an adjusted cash position of $393 million.

So now I'll ask Brian to share more details on these exciting financial results.

[Brian Di Donato, CFO & Head, Strategy]

Thank you, Bahija. Today, we'll focus on the highlights for the second quarter that you see on Slide 8. Please refer to the press release we issued this morning for our full financial results. Please note that as a foreign private issuer, we are currently reporting financial results under IFRS. For convenience, we converted the summary financials to U.S. dollars.

I'm excited to report that our teams continue to execute and to deliver KIMMTRAK to patients in the United States, Germany and France, with impressive site expansion and seamless reimbursement, all while continuing to manage our global early access programs. Highlights from the quarter include total second quarter net revenue of $33.7 million when converted to U.S. dollars. The second quarter marked our first full quarter of sales in the United States with KIMMTRAK revenue of $22.1 million.

Since May, we added $7.1 million in sales for Europe, which primarily consisted of converting 100% of our early access patients in Germany. Additionally, we continue to grow tebentafusp net revenue in France with $4.5 million of estimated reimbursement. We expect to have full marketing authorization and convert to the KIMMTRAK label in September.

For the year, we expect our product revenue to be based primarily in the United States, Germany and France. And we expect to gain final reimbursement agreement for Germany and France in the first half of 2023. In addition, we expect reimbursement agreements with additional European countries in 2023 and 2024.

On the expense side, SG&A expenses increased $5 million in the quarter due to increased commercialization costs before we credit $8 million of U.S. dollar currency gains. R&D expenses for the quarter were in line with Q1. However, as announced with the recent PIPE financing, we do expect development costs to increase into 2023, as we expand and accelerate our clinical development portfolio.

In July, we were pleased to report that we had a significant reverse inquiry for additional equity investment. We were across 4 of our largest and best long-term shareholders and executed a PIPE transaction with $140 million in equity proceeds. When combined with the $253 million of cash reported at the end of the quarter, this $393 million along with anticipated KIMMTRAK revenue in uveal melanoma will enable us to further accelerate our current clinical and research operating plan. This capital should fund the company through 2025 and into 2026.

I'm thankful for the seamless execution from our commercial and clinical teams, who have enabled us to bring KIMMTRAK to patients so quickly, both with our global early access program and now commercialization in a disease with such a significant unmet need. We also appreciate our shareholders, who continue to allow us to fund and accelerate our development pipeline, even in a challenging biotech market.

I will now turn the call over to Ralph, who will review some of our launch metrics for Q2 and objectives for the year. Ralph?

[Ralph Torbay, Head, Commercial]

Thank you, Brian. I'm delighted to be here today to provide you with an update on what has been an amazing first half of the year.

In Q1, following our successful approval and launch in the U.S., we transitioned all 69 patients from EAP to commercial supply. In Q2, we received EU approval in April, reimbursement in Germany in May and transitioned all 50 patients from EAP to commercial supply in a matter of weeks. The outstanding launches in U.S., Germany and France have delivered $46.5 million in revenue for the first half of the year.

In addition, these great achievements, we remain steadfast in our ambition of delivering KIMMTRAK to patients across the globe. We are now approved in over 30 countries, including recent approvals in the U.K., Australia and Canada. The medical team continues to build clinical confidence in KIMMTRAK, and I was delighted to see NCCN and ASCO guidelines recommending it as a standard of care for metastatic uveal melanoma.

Now let's review on Slide 11 the details of our U.S. launch performance. I am pleased to report that 124 accounts have infused patients with KIMMTRAK. We believe these accounts capture around 40% of the mUM patient opportunity in the U.S. As the team continues to focus on activating priority accounts, we are also supporting the transition and initiation of patients closer to home and into the community. So far, 1 of every 4 patients on KIMMTRAK is being treated in a community setting. Feedback from community physicians to date has been very positive and speaks to the predictable and manageable profile of KIMMTRAK.

From an access perspective, our teams have secured formal policy coverage for approximately 60% of all potential mUM patients in the U.S. In addition, I'm pleased to report that as of June 30, 99% of KIMMTRAK prescriptions were covered. We continue to work toward our goal of supporting access for every single patient that needs KIMMTRAK.

Turning to new patient starts. Today, 40% of KIMMTRAK patients are in first line. We're seeing positive momentum in our ability to displace entrenched checkpoint inhibitor competition. It is still too early for us to guide on what to expect from a duration of therapy perspective. However, discontinuation data remains in line with our expectations. I'm very grateful for the excellent launch execution that our U.S. team has delivered. Their efforts offer many patients a chance of longer survival.

Now let's transition to Europe, where the launches are going equally as well. In Germany, we've had a strong start since reimbursement of KIMMTRAK in May and the transition of all patients . In fact, our first patient was infused with commercial KIMMTRAK the same week we received price listing. Across Germany and France, 45 accounts have infused patients with KIMMTRAK.

We are seeing strong momentum in Germany with 30% of patients coming from first line. This only 2 months post launch. We are providing access in 10 additional countries through the expanded access program. Our value access team is prosecuting reimbursement across these geographies with many expected to launch in 2023. We remain determined in our ambition of delivering KIMMTRAK to patients across Europe.

A little more than a year ago, the team was challenged with creating a multinational commercial infrastructure to deliver the amazing innovation that is KIMMTRAK. Today, we have successfully launched in the U.S., Germany and France. Together, these countries represent the majority of the value opportunity for KIMMTRAK and have delivered so far $46.5 million in the first half of the year.

It remains early for us to guide as to the final numbers, the impact of bolus or the expected duration of therapy. However, we will continue to deliver strong execution, engagement and growth in these markets. I'm very proud of the highly dedicated team that is laser-focused on helping patients with KIMMTRAK. To that end, we're committed to the ambition of reaching over 1,000 new patients by 2025. We look forward to delivering this life-saving medicine to more patients globally.

With that, I thank you. And now I invite David to provide a portfolio update.

[David Berman, Head, Research & Development]

Thank you very much, Ralph. Our clinical program builds on the success of KIMMTRAK. And today, I'm going to update you on 3 other pillars. First, we are expanding KIMMTRAK beyond uveal melanoma by studying other types of melanoma, including cutaneous melanoma. Second, we are expanding beyond gp100 to larger indications with our programs targeting PRAME and MAGE-A4. And finally, we are expanding beyond oncology in our clinical programs for functional cure in HBV and HIV.

I will first provide an update on advanced melanoma. At ASCO, 2 months ago, we presented a survival update on our study of KIMMTRAK plus an anti-PD(L)1 in metastatic cutaneous melanoma patients, who progress on a prior anti-PD1. As we saw in uveal melanoma, survival was the best endpoint for capturing all the benefits in cutaneous melanoma. And here, we see a very promising 1-year survival of 75% for the combination.

Now to put this in context, the historical 1-year survival for this population is approximately 55% and that's seen across several recent benchmark trials. This differential gives us confidence to design a registrational program in advanced melanoma, including cutaneous melanoma with the survival endpoints.

Following discussions with global melanoma experts and with the U.S. FDA, we are excited to announce our new registrational Phase II/III trial in patients with any histologic type of melanoma, excluding only uveal melanoma. These patients have progressed on a prior anti-PD1 and received prior ipilimumab and, if appropriate, a prior tyrosine kinase inhibitor. This population is one of high unmet need and the best option for these patients is to enroll on clinical trials.

The study will randomize these patients to 3 arms, including number one, KIMMTRAK alone; number two, KIMMTRAK with an anti-PD1; and number three, a control arm. The control arm is innovative, in that patients go straight to survival follow-up. And this enables the investigator discretion to choose any therapy, including even enrolling the patients on other clinical trials. Therefore, we are randomizing essentially to a real-world treatment option rather than offering chemotherapy, which is generally considered ineffective. The FDA has accepted this design since the primary endpoint is overall survival, which is standard data collection in follow-up from any clinical trial.

The primary endpoint of the Phase II is reduction in ctDNA and overall survival. And data from the Phase II provides us optionality to inform changes to the Phase III, including moving into earlier lines of therapy, dropping an arm or even repowering the study to make it smaller.

As the pioneer in TCR Therapeutics, I am proud that we have published extensively on the science of KIMMTRAK, from the mechanism to safety to efficacy. And with over 500 uveal melanoma patients treated in clinical trials, we now have insights that provide a blueprint for how we develop our other , including MAGE and PRAME.

And this blueprint is summarized here. First, we must demonstrate that the ImmTAC is activating T cells and redirecting them to the tumor. Second, the hallmark of KIMMTRAK was durable clinical benefit, which includes durable tumor shrinkage shown in green and durable partial responses shown in yellow, with some ongoing for over 1-year. Third, we see survival benefit regardless of whether the patients have high or low expression of the parent gp100 protein, which is reflected by the H score.

Now we do note that there was an enrichment for RECIST partial responses at the higher H score. And fourth, early ctDNA reductions was a strong and early surrogate of survival. And for uveal melanoma and KIMMTRAK indicates up to 70% of patients may be having benefit based on ctDNA decrease. Of course, the ultimate goal for all patients is overall survival, and this is where we ultimately will look.

Beyond KIMMTRAK, we have 2 clinical ImmTACs targeting larger cancer indications. F106C targets PRAME, which has the potential for 150,000 patients. The Phase I data was accepted for oral presentation at ESMO next month. And there will be more than 20 patients, who are PRAME-positive, treated at active doses and to our efficacy evaluable. C103C targets MAGE-A4, which has the potential for 60,000 patients. The Phase I dose escalation continues as is the expansion in ovarian carcinoma, and we will update the progress later this year.

This platform can be applied beyond oncology to infectious disease, and I am pleased to update you on our progress here. Chronic viral infections, such as HIV and HBV, may result in a reservoir that is not eradicated by currently available direct-acting antivirals. Our platform should be applicable to eliminating this reservoir to achieve functional cure. We initiated all of our Phase I studies, including our HBV functional cure program and what are called MABEL doses, which are intended to be subtherapeutic. However, we find that our molecules are so potent that even at the MABEL dose for the HBV program, we see the exact on-target biomarkers that we expect to see, including a transient decrease in HBV surface antigen, which is a marker of disease, with a concomitant increase in ALT.

Now the changes we see are small. But one must remember that this initial dose was below 1 microgram, and it's remarkably seen after only a single dose, and we certainly look forward to seeing what happens at higher doses. And finally, I am pleased to announce that we have achieved first patient dosing in our HIV functional cure program.

And now I'm going to hand it back to Bahija.

[Bahija Jallal, CEO & Director]

Thank you, David, Ralph, and thank you, Brian. As you have heard, it has been a very successful quarter, and I could not be more proud and also thankful to this team's leadership. So looking into the rest of the year, we still have more work to do, and we're very happy about that. We will be from the milestones we are on track. So we'll continue the commercial launch and continue to get approval in other countries.

Looking into Q4, we expect to have the first patients enrolled in the advanced melanoma trial that David just shared with you. We are on track of presenting the data in Q3 for PRAME in Paris in ESMO. And then we're on track to presenting data for MAGE-A4 -- updates on MAGE-A4 in Q4, and then continuing the enrollment of HIV and HBV programs.

Just want to reflect before we take your questions. At the beginning of 2022, I said this would be a year of execution and the team did just that. They were laser-focused. And so far, we have achieved everything we said we would. I feel and we all feel really privileged to be in the business of bringing medicines with meaningful benefits to patients, a benefit that will truly impact their lives. I'm humbled by the efforts of my team and our employees. Our patients are counting on us, and we take this responsibility very seriously.

So we have a few minutes left, and we'll be happy to answer your questions. Thank you.

[Operator]

[Operator Instructions]. Our first question comes from the line of Michael Yee with Jefferies.

[Michael Yee, Jefferies]

Bahija, congrats on the progress and a great quarter. We had a commercial question and a pipeline question. On the commercial front, although it's early in the launch in U.S. and Europe, do you expect a steady continuous growth in the following quarters beyond just EAP people that have come on, both from new patients coming on, but also -- do you get the sense early on that people are staying on duration of therapy beyond just 5 months based on your experience and what you're seeing in the commercial setting?

And then from a pipeline question, maybe for David. I know that people are focused on ESMO and I know we'll get the data soon. On one hand, gp100 has shown lower response rates, but much longer OS. And I think there's a question whether it's a mechanism or just a target thing. How do you think about framing expectations for PRAME, given what we know with a PRAME's pretty active target?

[Bahija Jallal, CEO & Director]

Thank you, Michael. The great questions. We'll start with Ralph, maybe, to take the question on commercial?

[Ralph Torbay, Head, Commercial]

Sure. Thank you, Bahija, and thank you, Michael, for the question. So Look, I mean, you spoke of the EAP and the patients coming from the EAP. So there's that piece of bolus that were trials and the team has executed so well that all patients transitioned into commercial supply weeks within approval. However, we're still the first medicine to launch in this space in over 4 decades. So really, we don't have a good analog to base this on. I just -- I expect the team will continue to do great work. And it's still too early, however, for us to really comment given that we have 5 months of launch in the U.S., 2 months in Germany. And duration of therapy really has not materialized. But as I mentioned, discontinuation rates are in line with what we expect.

[Bahija Jallal, CEO & Director]

Great. David, do you want to comment on the?

[David Berman, Head, Research & Development]

Yes. So Michael, we know that PRAME is a good target. We've seen that before. It tends to be homogenous and the peptide density is high. And we've seen from others that it is an active target. So we're -- we know it's a good target. From our platform, what we've seen is, we've seen durable benefit, we've seen , we've seen tumor shrinkage, and we've seen ctDNA reduction. Those are the hallmarks of what we've seen with our platform. So we're 1 month away from the data, and I think we'd be happy to discuss more of it after we share the data.

[Operator]

Our next question comes from the line of Jessica Fye with JPMorgan.

[Jessica Fye, JPMorgan Chase & Co.]

Nice quarter. A couple on KIMMTRAK and a couple on PRAME. First, in the U.S., how many legacy EAP patients were still on KIMMTRAK the end of 2Q? And appreciating that it's a bit early to talk definitively about duration of treatment, can you talk directionally about what you see emerging with KIMMTRAK? For example, with 5 months within the U.S., can you say whether it might be tracking better than or at least no worse than the 5.3 months median treatment duration observed in the Phase III trial?

And then moving on to PRAME, what tumor types should we expect to see represented in the ESMO update? And how should we think about the length of follow-up for those PRAME-positive patients, who are treated at relevant doses?

[Bahija Jallal, CEO & Director]

Thank you, Jess. Several questions in here. So we'll start with the first one. Maybe you can take it, Ralph, and then we'll go to David.

[Ralph Torbay, Head, Commercial]

Thank you, Bahija. And thank you, Jeff, for the question. So starting with the U.S., you spoke of the legacy EAP patients. So really a lot of these patients were in second line. Today, what we see is that 40% of our patients are coming from first line. The team continues to activate accounts with KIMMTRAK, so far, we have 124 accounts. So really what you can expect is more of this good execution, and I can't really comment currently on DOT because we're too early in the launch. However, discontinuations are in line with what we expect, as I said. Thank you.

[Bahija Jallal, CEO & Director]

David, do you want to talk about the tumor types in ESMO?

[David Berman, Head, Research & Development]

Yes. So this is a basket trial, Jess. And so we don't control the types of tumor, that's up to the investigators to enroll. So there is a variety of different tumor types. In terms of length of follow-up, there -- we do have a follow-up on patients over a month. So I think we'll have a sense of sufficient durability.

[Jessica Fye, JPMorgan Chase & Co.]

Great. Can I just clarify the KIMMTRAK comment, is that 40% of the new patients that you're picking up are first line, or 40% of the overall U.S. patients now on KIMMTRAK are first line?

[David Berman, Head, Research & Development]

Jess, it's 40% of the now patients on KIMMTRAK are in first line.

[Operator]

Our next question comes from the line of Tyler Van Buren with Cowen and Company.

[Tyler Van Buren, Cowen and Company]

Congratulations on the stellar KIMMTRAK results. I guess I'll ask about cutaneous melanoma given the newly announced trial design requiring patients to be previously treated. Since it requires patients to be both previously treated with both a checkpoint inhibitor and . Does the 1-year survival benefit analysis that you presented at ASCO separate more? If you just look at the patient population with checkpoint and epi experience as they might be more severe? And just a follow-up to that is the control arm, I believe you said patients could be switched to KIMMTRAK, so how do you expect that to impact the survival analysis?

[David Berman, Head, Research & Development]

So for the first question, the historical 1-year survival is mostly in patients who progressed on prior PD1 and (technical difficulty) also even seen for in patients who progressed on prior PD1. Patients who we're enrolling here, who have progressed on PD1 and IPI, might even have a lower 1-year survival. And in fact, that's part of the reason to do the Phase II part to see the actual treatment effect, which might be the same or larger.

In terms of the control arm, it is straight to survival follow-up and investigators can choose whatever they want to enroll the patients on. We believe most of the patients will be enrolled on other investigational agent clinical trials. So I don't think that, that will really impact the powering of the study.

[Operator]

Our next question comes from the line of Patrick Trucchio with H.C. Wainwright.

[Patrick Trucchio, H.C. Wainwright & Co.]

Congrats on all the progress in the quarter. Just a clarification question just in terms of the KIMMTRAK launch in European markets. Just in which European markets would you expect to be launching in 2023 and 2024? And how many patients would be expected to be transitioned to commercial supply at the times of those launches? And then -- just in terms of the HBV program, can you discuss the said trial results a bit more in terms of reduction in surface antigen. Was this in line with your expectations? How would you characterize the ALT elevations that we're seeing? What could we expect as this dose level increases? And finally, do you envision moving the HBV program eventually forward in combination with other antiviral or immune stimulatory mechanisms or would you be moving it forward on its own?

[Bahija Jallal, CEO & Director]

Yes. Thank you, Patrick. I think you have several questions here. Maybe we can start with the KIMMTRAK launches in the EU, Ralph?

[Ralph Torbay, Head, Commercial]

Thank you, Patrick, for the question. So Look, in the EU, as you know, the launches will depend on reimbursement. And we're actively engaged and have submitted those to a lot of these countries. At the moment, I can't really comment on when the launches will happen because, as you know, these are negotiations. What I can tell you, though, is that you can expect the same level of execution from the team in all of the geographies where we have an EAP ongoing.

[David Berman, Head, Research & Development]

In terms of the HBV questions, Patrick, so there were 3 markers we were really looking for when we started the program, but frankly, we didn't expect to see them until we got the higher doses. We were expecting to eventually to see ALT increases because we would potentially be killing hepatocytes than releasing ALT. We expected to see IL-6 increase, and we expected to see lymphocyte trafficking. Those -- that is really all we expected to see in the . And that is why it was remarkable in the first initial dose at such a low dose, as I mentioned, that we saw an increase in ALT, an increase in IL-6 and even a few patients having lymphocyte trafficking.

What was totally unexpected for me is to see even at this initial dose any surface antigen change, I really didn't expect to see that until the MAD. And I think that's why we were so excited. In terms of your second question, the current study is in the background of . And this is a platform that can be combined with anything. So we do see it as combinable with any other therapy.

[Bahija Jallal, CEO & Director]

Great. Thanks, David.

[Operator]

Our next question comes from the line of Justin Kim with Oppenheimer & Company.

[Justin Kim, Oppenheimer]

Congrats on the progress. Maybe just on KIMMTRAK. Has the team observed any patterns between first-line or second-line treated patients? Just wondering if physician experience is the driver here and whether we might expect this to change over time?

[Bahija Jallal, CEO & Director]

Thank you, Justin. Do you want to take that, Ralph?

[Ralph Torbay, Head, Commercial]

Sure. So Justin, I mean, you'd expect second-line patients. And really, when we're talking about second-line patients, we're talking about second line plus. So you have patients who have seen 3 line therapies and so on. So second-line patients tend to be sicker overall. So we do see a better experience in first line. And obviously, this is where we've seen the OS benefit. So our focus and commitment is to really establish KIMMTRAK as a standard of care in first line, and that's what the team is focusing on.

[Justin Kim, Oppenheimer]

Okay. Got it. And in terms of sort of that 60% of remaining patients in the U.S. that the team is hoping to get on treatment, do you see these as more accessible through the community setting? Just kind of trying to understand what sort of steps from an execution standpoint will enable reaching these patients more or easily?

[David Berman, Head, Research & Development]

So as you said in your question, a lot of these patients are in the community. So we're accessing the community patients in several ways. One is through obviously what you usually do with the omnichannel approach, digital approaches as on because the community space is so large. But really, we have our field force going after the community. We see 1 in 4 patients now transitioned into the community. Feedback from physicians in the community has been very positive to date. They do talk about the predictable, manageable profile of KIMMTRAK. So we do expect to have good penetration in the community as the launch goes on.

[Operator]

Our next question comes from the line of Justin Zelin with BTIG.

[Justin Zelin, BTIG]

Congrats on the strong quarter here. I wanted to ask about any expectations for the upcoming PRAME data at ESMO next month. Or if you're not able to give any color here, it would be great to have David talk about how your modality is differentiated from other approaches in the field.

[Bahija Jallal, CEO & Director]

Yes. Thank you, Justin. I think it is only 1 month, but we can -- David can comment on what are the data that we'll be bringing, David?

[David Berman, Head, Research & Development]

Yes. I mean, I'll comment on the -- on what differentiates our platform. I mean first, we have validated, shown a survival benefit with KIMMTRAK. We've shown the durability of that benefit, if you see the Kaplan-Meier curves remain separated. The patients who have tumor shrinkage or PRs have very durable tumor shrinkage of PRs. We've shown very rapid onset of effect if you see the Kaplan-Meier curve separate very early. And we've shown a good safety profile both for MAGE-A4 and for gp100. So we feel this is the first mechanism that's shown for bispecifics that's shown such promising data in solid tumors. And we believe it can be applicable broadly.

[Operator]

Our next question comes from the line of Matt Phipps with William Blair.

[Matthew Phipps, William Blair & Company]

Congrats on the quarter. Two quick ones for Ralph, I assume. Ralph, you specifically said that discontinuation data is kind of in line with expectations. Do you have any sense of treatment beyond progression in the kind of real-world setting at this point? And then secondly, you now have 10 countries where EAP is open. I wonder if you can -- maybe give us a sense of how many patients are on EAP in those countries beyond Germany and France.

[Bahija Jallal, CEO & Director]

Okay. Ralph, do you want to take the first one? And maybe, Brian, you can comment on the second. Go ahead.

[Ralph Torbay, Head, Commercial]

Sounds good. Thank you, Matt, for the question. So when you think about treatment beyond progression, the practice was already established with checkpoint inhibitors, but it's not at the level where we need it with KIMMTRAK to maximize patient outcomes as we've seen them in the trial. This is why we made sure that this made it into our label, and we continue to educate on it. So it's still a little bit early to comment on where that would land. The team is actively working at building the education here. But as I said, it's...

[Bahija Jallal, CEO & Director]

Yes, I think I would add like in academic centers is not going to be of an issue. They're used to seeing that. I think on the community setting, we have to do more of education, and that's exactly what the are doing.

Do you want to comment on the EAP, Brian?

[Brian Di Donato, CFO & Head, Strategy]

Yes. You don't include France and Germany, Matt. We still have 10 countries that are still enrolling on EAP. So we now have over 100 patients still on the EAP. And as Ralph mentioned, as we move into 2023 and 2024 and seek reimbursement in those countries, we expect to transition those patients.

[Operator]

Our next question comes from the line of Gil Blum with Needham & Company.

[Gil Blum, Needham & Company]

Also, I'd like to add my congratulations on your quarter. So you mentioned about 124 accounts of capturing about 40% . Do you think you have the potential for higher penetrations in the accounts you already have relationships with? Then I have a follow-up on [indiscernible].

[Bahija Jallal, CEO & Director]

Ralph?

[Ralph Torbay, Head, Commercial]

So Gil, we're currently working on those accounts to get them trained to get all their staff trained. I mean when you think of an account, you think about several physicians being in that account. So we do have great penetration or market share with the physicians that are familiar with tebe and KIMMTRAK. However, of course, we're still working through making sure that everyone in those accounts is prescribed KIMMTRAK as first-line treatment.

[Gil Blum, Needham & Company]

That's very helpful. And as for -- maybe a bit of a follow-on on Michael's question from before. How relevant is ORR for a study like this given that the real benefit only shows up a lot later, I mean, with patients that have responses that can last a long time. But maybe you don't get a big ORR upfront.

[Bahija Jallal, CEO & Director]

Are you -- just a clarification. Are you talking about the KIMMTRAK in cutaneous, or are you talking about PRAME?

[Gil Blum, Needham & Company]

PRAME.

[Bahija Jallal, CEO & Director]

Okay. Thank you.

[David Berman, Head, Research & Development]

Yes. So first, I would just say that our largest data set is with KIMMTRAK, that's point number one. And there, we see the survival benefit at both high and low H score, but we do see RECIST PRs at the higher H score. And it's really an open question that we've been trying to ask as we go to other targets is whether this is going to be the same pattern we see or not. And so I think between MAGE and PRAME, which tends to have a higher H score and more homogenous staining, I think we'll begin to answer the question.

[Bahija Jallal, CEO & Director]

Correct. Just basically, is it a platform effect or if it's dependent on the targets, and I think hopefully would have an answer.

[Operator]

Thank you. Ladies and gentlemen, we have reached the end of the question-and-answer session. I will now turn the call back over to management for closing remarks.

[Bahija Jallal, CEO & Director]

Well, great, operator. Thank you so much for everyone, and we look forward to seeing you maybe at the ESMO. Thank you. Bye.

[Operator]

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.