Full Year 2025 Nanobiotix SA Earnings Call
Speaker #1: Good day and thank you for standing by Welcome to the Nanobiotix S.A. full year 2025 Financial Results conference call At this time , all participants are in a listen only mode After the speakers presentation , there will be a question and answer session To ask a question during the session , you will need to press star one one on your telephone .
Operator: Good day, and thank you for standing by. Welcome to the Nanobiotix Full Year 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joanne Choi, Head of Investor Relations, US. Please go ahead.
Operator: Good day, and thank you for standing by. Welcome to the Nanobiotix full year 2025 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joanne Choi, Head of Investor Relations, US. Please go ahead.
Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again.
Speaker #1: Please be advised that today's conference is being recorded . I would now like to hand the conference over to your speaker today , Joanne Choi , Head of Investor Relations , US .
Speaker #1: Please go ahead
Speaker #2: Thank you, Heidi. Good afternoon and good morning, and welcome to the Nanobiotix conference call to discuss our full year 2025 financial and operational results.
Joanne Choi: Thank you, Heidi. Good afternoon and good morning, and welcome to the Nanobiotix conference call to discuss our full year 2025 financial and operational results. Joining me on the call today are Laurent Levy, Co-founder and Chief Executive Officer, and Bart Van Rhijn, Chief Financial and Business Officer. Today's call is being webcast and will be available on our website for replay. Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of applicable securities laws. These statements are based on our current expectations, assumptions, and available information and are subject to significant risks and uncertainties that could cause actual results to differ materially. Such risks include, among others, those related to the timing, progress, and outcomes of our research and clinical development programs, regulatory developments, and our financial and operational performance.
Joanne Choi: Thank you, Heidi. Good afternoon and good morning, and welcome to the Nanobiotix conference call to discuss our full year 2025 financial and operational results. Joining me on the call today are Laurent Levy, Co-founder and Chief Executive Officer, and Bart Van Rhijn, Chief Financial and Business Officer. Today's call is being webcast and will be available on our website for replay. Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of applicable securities laws. These statements are based on our current expectations, assumptions, and available information and are subject to significant risks and uncertainties that could cause actual results to differ materially. Such risks include, among others, those related to the timing, progress, and outcomes of our research and clinical development programs, regulatory developments, and our financial and operational performance.
Speaker #2: Joining me on the call today are Laurent Levy, Co-Founder and Chief Executive Officer, and Bart Van Rhijn, Chief Financial and Business Officer.
Speaker #2: Today's call is being webcast and will be available on our website for replay. Before we begin, I would like to remind you that today's discussion will include forward-looking statements.
Speaker #2: Within the meaning of applicable securities laws . These statements are based on our current expectations , assumptions and available information and are subject to significant risks and uncertainties that could cause actual results to differ materially Such risks include , among others , those related to the timing , progress and outcomes of our research and clinical development programs .
Speaker #2: Regulatory developments and our financial and operational performance. We encourage you to review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the US, which are available on the Investor Relations section of our website.
Joanne Choi: We encourage you to review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the US, which are available on the Investor Relations section of our website. Any forward-looking statements made during this call reflect our views as of today and should not be relied upon as representing our views as of any subsequent date. Thank you. I will now turn the call over to Laurent. Please go ahead.
Joanne Choi: We encourage you to review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the US, which are available on the Investor Relations section of our website. Any forward-looking statements made during this call reflect our views as of today and should not be relied upon as representing our views as of any subsequent date. Thank you. I will now turn the call over to Laurent. Please go ahead.
Speaker #2: Any forward-looking statements made during this call reflect our views as of today and should not be relied upon as representing our views as of any subsequent date.
Speaker #2: Thank you. I will now turn the call over to Laurent. Please go ahead.
Speaker #3: Thank you, and thank you, everyone. Good morning, good afternoon. Really happy to be here with you today to share our 2025 year and to give you a bit of perspective of what's going to happen in the next 12 to 18 months.
Laurent Levy: Thank you, Joanne, and thank you everyone. Good morning. Good afternoon. Really happy to be here with you today to share our 2025 year and to give you a bit of perspective of what's going to happen in the next 12, 18 months. Today we're gonna go over different aspects of things, how we've been moving the company for the past year, and also give some financial highlight and then open for Q&A session. I think we've had a very rich 2025. We've been able to do many things during this year. First of all, start moving forward in a good way, the collaboration we have with Johnson & Johnson, and start showing the potential of this first product along with the potential of this deal in terms of future revenue for Nanobiotix.
Laurent Levy: Thank you, Joanne, and thank you everyone. Good morning. Good afternoon. Really happy to be here with you today to share our 2025 year and to give you a bit of perspective of what's going to happen in the next 12, 18 months. Today we're gonna go over different aspects of things, how we've been moving the company for the past year, and also give some financial highlight and then open for Q&A session. I think we've had a very rich 2025. We've been able to do many things during this year. First of all, start moving forward in a good way, the collaboration we have with Johnson & Johnson, and start showing the potential of this first product along with the potential of this deal in terms of future revenue for Nanobiotix.
Speaker #3: So today we're going to go over different aspects of things, how we've been moving the company for the past year, and also give some financial highlights.
Speaker #3: And then open for Q&A session. I think we've had a very rich 2025. We've been able to do many things during this year.
Speaker #3: First of all, start moving forward in a good way. The collaboration we have with Johnson & Johnson, and start showing the potential of this first product, along with the potential of this deal in terms of future revenue for Nanobiotix S.A.
Speaker #3: While doing so, we've also been pivoting the company toward the new platform, which has been a big effort from the team.
Laurent Levy: While doing so, we've been also pivoting the company toward the new platform, which has been a big effort from the team, and I would like to thank them all for that. While doing those operational things in parallel, we've been able to really improve our cash visibility into 2028, and this beyond the timing of some of the expected milestones that should come from the collaboration with J&J. All together, we've had a rich year, and we're pleased to share that with you. Now we're going to go in some more details to give you a bit of insight. Before getting there, we'd just like to remind a few things about the philosophy with which we are developing things at Nanobiotix. As you can see here, we mentioned delivering first in class directly. I think definitely we are doing more than this.
Laurent Levy: While doing so, we've been also pivoting the company toward the new platform, which has been a big effort from the team, and I would like to thank them all for that. While doing those operational things in parallel, we've been able to really improve our cash visibility into 2028, and this beyond the timing of some of the expected milestones that should come from the collaboration with J&J. All together, we've had a rich year, and we're pleased to share that with you. Now we're going to go in some more details to give you a bit of insight. Before getting there, we'd just like to remind a few things about the philosophy with which we are developing things at Nanobiotix. As you can see here, we mentioned delivering first in class directly. I think definitely we are doing more than this.
Speaker #3: And I would like to thank them all for that. While doing those operational things in parallel, we've been able to really improve our cash visibility into 2028.
Speaker #3: And this is beyond the timing of some of the expected milestones that should come from the collaboration with JNJ. So altogether, we've had a rich year here, and we are pleased to share that with you.
Speaker #3: And now we're going to go into some more details to give you a bit of insight before getting there. We'd just like to remind you of a few things about the philosophy with which we are developing things at Nanobiotix S.A.
Speaker #3: . So as you can see here , we mentioned delivering first in class directory , but I think . Definitely we're doing more than this .
Speaker #3: We are creating a new class of drugs. That's what we have done for the radio enhancer, for the nano primer, and also for the last platform, Acuity.
Laurent Levy: We are creating new class of drugs. That's what we have done for the radioenhancer, for the Nanoprimer, and also for the last platform, Curadigm. That's really our philosophy. We don't want to do what other biotech are doing, not because it's bad, because we think there are enough people working on the same target with the same technologies. We really want to bring something deep and different to help millions of patients. That's what we're trying to do and we continue to do. Our strategy is simple and stay aligned with what we told you last year. First of all is to continue to push and help J&J to address one of the potentially largest untapped markets in oncology. That's through our first product, radioenhancer, that has been licensed to Johnson & Johnson.
Laurent Levy: We are creating new class of drugs. That's what we have done for the radioenhancer, for the Nanoprimer, and also for the last platform, Curadigm. That's really our philosophy. We don't want to do what other biotech are doing, not because it's bad, because we think there are enough people working on the same target with the same technologies. We really want to bring something deep and different to help millions of patients. That's what we're trying to do and we continue to do. Our strategy is simple and stay aligned with what we told you last year. First of all is to continue to push and help J&J to address one of the potentially largest untapped markets in oncology. That's through our first product, radioenhancer, that has been licensed to Johnson & Johnson.
Speaker #3: And that's really our philosophy. We don't want to do what other biotech are doing—not because it's bad, but because we think there are enough people working on the same target with the same technology.
Speaker #3: So we really want to bring something deep and different to help millions of patients. And that's what we're trying to do. And we continue to do.
Speaker #3: Our strategy is simple and stays in line with what we told you last year. First of all, it is to continue to push and help JNJ to address one of the potentially largest untapped markets in oncology.
Speaker #3: And that's true . Our first product , radio announcer that has been licensed to Johnson and Johnson . And beyond this product , we're really pushing hard on new platforms , starting with the current platform , which we think is going to disrupt part of how we think about drug development .
Laurent Levy: Beyond this product, we're really pushing hard on new platforms, starting with the Curadigm platform, which we think is going to disrupt part of how we think about drug development. We have been starting making good progress in that regard this year. Obviously, we will come back to that in more details. Let's focus first on NBTXR3 or JNJ-1900. What do we mean by addressing one of the largest untapped market in oncology? Well, I think for that, we still need to look at patients. When patients are diagnosed with cancer, the vast majority of them have a local disease. It's more than 70% of patients having a local disease at diagnosis. Our industry in general is more focused on late stage treatment of patients when they get metastatic or have received several lines of treatment.
Laurent Levy: Beyond this product, we're really pushing hard on new platforms, starting with the Curadigm platform, which we think is going to disrupt part of how we think about drug development. We have been starting making good progress in that regard this year. Obviously, we will come back to that in more details. Let's focus first on NBTXR3 or JNJ-1900. What do we mean by addressing one of the largest untapped market in oncology? Well, I think for that, we still need to look at patients. When patients are diagnosed with cancer, the vast majority of them have a local disease. It's more than 70% of patients having a local disease at diagnosis. Our industry in general is more focused on late stage treatment of patients when they get metastatic or have received several lines of treatment.
Speaker #3: And we have been starting to make good progress in that regard this year. Obviously, we will come back to that in more detail, but let's focus first on NBTXR3.
Speaker #3: Or JNJ 1900 . What do we mean by addressing one of the largest untapped market in oncology ? Well , I think for that we still need to look at patients .
Speaker #3: And when patients are diagnosed with cancer, the vast majority of them have a local disease. It's more than 70% of patients having a local disease at diagnosis.
Speaker #3: And our industry, in general, is more focused on late-stage treatment of patients when they get metastatic or have received several lines of treatment.
Speaker #3: If you think about it, if you want to have a big impact for those patients, it will be much better, if possible, to treat them at the beginning of their disease and try to eradicate the tumor when it's still at the local stage.
Laurent Levy: If you think about it, if you want to have a big impact for those patients, it will be much better, if possible, to treat them at the beginning of their disease and try to eradicate the tumor when it's still at a local stage. That's exactly what we are trying to achieve with NBTXR3. For that, we're working with radiation therapy, which is one of the largest treatments used in oncology. More than 60% of all cancer patients are getting radiation. We have a product that we licensed to JNJ that fits this existing market with almost no competition. As you can see on this slide, we have a very large pipeline, linked to this product that have been developing across many tumor.
Laurent Levy: If you think about it, if you want to have a big impact for those patients, it will be much better, if possible, to treat them at the beginning of their disease and try to eradicate the tumor when it's still at a local stage. That's exactly what we are trying to achieve with NBTXR3. For that, we're working with radiation therapy, which is one of the largest treatments used in oncology. More than 60% of all cancer patients are getting radiation. We have a product that we licensed to JNJ that fits this existing market with almost no competition. As you can see on this slide, we have a very large pipeline, linked to this product that have been developing across many tumor.
Speaker #3: And that's exactly what we are trying to achieve with Nbtxr3 . And for that , we're working with radiation therapy , which is one of the largest treatments used in oncology , has more than 60% of all cancer patients are getting radiation .
Speaker #3: And we have a product that we licensed to JNJ that fits this exhausting market with almost no competition. And as you can see on this slide, we have a very large pipeline linked to this product that we have been developing across many tumors.
Speaker #3: And technically, that's just a few examples of what could be done with this product, because there are many, many other patients getting radiation in different oncology indications.
Laurent Levy: Technically, that's just a few examples of what could be done with this product because there are many, many other patients getting radiation in different oncology indications. Let's try to look at where is the value here, what are the next key points of inflection, and how are we going to bring that to next steps. This year. Last year, sorry, 2025, we've been publishing additional data in different cancer types. On top of the already established proof of concept in soft tissue sarcoma, the first data in head and neck cancer, we've been able to continue to show that this product could be widely applicable in oncology. Through 2025, we've been publishing data on head and neck cancer by talking here about the recurrent metastatic patients, also pancreatic cancer, esophageal cancer, melanoma cancer, and lung cancer.
Laurent Levy: Technically, that's just a few examples of what could be done with this product because there are many, many other patients getting radiation in different oncology indications. Let's try to look at where is the value here, what are the next key points of inflection, and how are we going to bring that to next steps. This year. Last year, sorry, 2025, we've been publishing additional data in different cancer types. On top of the already established proof of concept in soft tissue sarcoma, the first data in head and neck cancer, we've been able to continue to show that this product could be widely applicable in oncology. Through 2025, we've been publishing data on head and neck cancer by talking here about the recurrent metastatic patients, also pancreatic cancer, esophageal cancer, melanoma cancer, and lung cancer.
Speaker #3: But let's try to look at where is the value here. What are the next key points of inflection, and how are we going to bring that to the next steps this year?
Speaker #3: Last year , sorry , 2025 . We've been publishing additional data in different cancer types on the top of the already established proof of concept in soft tissue sarcoma .
Speaker #3: The first data in head and neck cancer, we've been able to continue to show that this product could be widely applicable in oncology through 2025.
Speaker #3: We've been publishing data on head and neck cancer , but talking here about recurrent metastatic patients also , pancreatic cancer as of cancer , melanoma , cancer and lung cancer .
Speaker #3: All those data have been showing not only that you could use safely in Dcr3 in different indications, but also start to show some potential good hint of efficacy for those different indications, and altogether, some consistency in the way you administer a product.
Laurent Levy: All those data have been showing not only that you could use safely NBTXR3 in different indications, but also start to show some potential of efficacy for those different indications. Altogether, some consistency in the way you administer the product, but more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefits to patients. Let's focus on the two key developments. As you know, we've been transferring to Johnson & Johnson last year the ongoing phase 3 in head and neck cancer. That's a very important trial as a phase 3 and could lead, if positive, to first approval and first market activity around NBTXR3. This trial is progressing well. JNJ now has the full operation on this, and also the financial aspect of this trial are taken care of by J&J.
Laurent Levy: All those data have been showing not only that you could use safely NBTXR3 in different indications, but also start to show some potential of efficacy for those different indications. Altogether, some consistency in the way you administer the product, but more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefits to patients. Let's focus on the two key developments. As you know, we've been transferring to Johnson & Johnson last year the ongoing phase 3 in head and neck cancer. That's a very important trial as a phase 3 and could lead, if positive, to first approval and first market activity around NBTXR3. This trial is progressing well. JNJ now has the full operation on this, and also the financial aspect of this trial are taken care of by J&J.
Speaker #3: But more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefit to patients. But let's focus on the two key developments.
Speaker #3: As you know, we've been transferring to Johnson & Johnson. Last year, the ongoing phase three in head and neck cancer.
Speaker #3: That's a very important trial as a Phase 3 and could lead, if positive, to first approval and first market activity around NBTXR3.
Speaker #3: This trial is progressing well. JNJ now has the full operation on this, and also the financial aspect of this trial is taken care of by Zhang J.
Speaker #3: And we still expect to get the first readout of this trial . The first half of next year . You may have noticed that on the top of this phase , three JNJ has also started a phase one B in another population of head and neck , meaning patients getting radiation plus cisplatin .
Laurent Levy: We still expect to get the first readout of this trial H1 next year. You may have noticed that on top of this phase 3, J&J has also started a phase 1b in another population of head and neck, meaning patients getting radiation plus cisplatin. If you think about head and neck cancer, with those two trials, you're technically capturing all the frontline patients that have a locally advanced tumor and that receive radiation and that cannot go to surgery. Technically, if you exclude the few patients that have metastasis at diagnosis, with those two trials, you could capture the vast majority of head and neck cancer patients first-line treatment with the highest unmet medical need.
Laurent Levy: We still expect to get the first readout of this trial H1 next year. You may have noticed that on top of this phase 3, J&J has also started a phase 1b in another population of head and neck, meaning patients getting radiation plus cisplatin. If you think about head and neck cancer, with those two trials, you're technically capturing all the frontline patients that have a locally advanced tumor and that receive radiation and that cannot go to surgery. Technically, if you exclude the few patients that have metastasis at diagnosis, with those two trials, you could capture the vast majority of head and neck cancer patients first-line treatment with the highest unmet medical need.
Speaker #3: If you think about head and neck cancer with those two trials, you’re technically capturing all the patients frontline that have a locally advanced tumor and that receive radiation and that cannot go to surgery.
Speaker #3: So technically , if you accept a , you exclude , sorry , the few patients that have metastases at diagnosis with those two trials , you could capture the vast majority of cancer patients .
Speaker #3: First line treatment with the highest unmet medical need . So that's a very important pathway . And could , if positive , establish an three as a key player in all head and neck cancer treatment .
Laurent Levy: That's a very important pathway and could, if positive, establish NBTXR3 as a key player in the whole head and neck cancer treatment. Now, there is another trial which is equally important and potentially even more important. We're talking about here the first lung cancer trial that J&J is running. The name of this trial is CONVERGE. It's a randomized phase 2 trial in unresectable stage 3 non-small cell lung cancer. This trial is important for many reasons. First of all, as you may have seen, lung cancer is a very important aspect of the strategy of J&J in oncology. It's also, as you know, a gigantic market, if not the biggest market, with breast cancer.
Laurent Levy: That's a very important pathway and could, if positive, establish NBTXR3 as a key player in the whole head and neck cancer treatment. Now, there is another trial which is equally important and potentially even more important. We're talking about here the first lung cancer trial that J&J is running. The name of this trial is CONVERGE. It's a randomized phase 2 trial in unresectable stage 3 non-small cell lung cancer. This trial is important for many reasons. First of all, as you may have seen, lung cancer is a very important aspect of the strategy of J&J in oncology. It's also, as you know, a gigantic market, if not the biggest market, with breast cancer.
Speaker #3: Now, there is another trial which is equally important and potentially even more important. We're talking about here the first lung cancer trial that JNJ is running.
Speaker #3: The name of this trial is CONVERGE. It's a randomized phase two trial in unresectable stage three non-small cell lung cancer. This trial is important for many reasons.
Speaker #3: First of all , as you may have seen , lung cancer is a very important aspect of the strategy of JNJ in oncology and is also , as you know , a gigantic market , if not the biggest market with breast cancer .
Speaker #3: So here, starting with this trial, assuming that the data are positive, what we feel at Nanobiotix is that this could be a trigger for Johnson & Johnson to start expanding the development.
Laurent Levy: Here, starting with this trial, assuming that the data are positive, what we feel at Nanobiotix is that could be a trigger for Johnson & Johnson to start expanding the development. If we just stick to lung cancer, that's already a gigantic market per se. Here we're talking about stage three, but it could expand into some other indication in lung cancer. Maybe as we did not have the occasion to talk about the data that have been generated, the first part of this data, let's have a small focus on that.
Laurent Levy: Here, starting with this trial, assuming that the data are positive, what we feel at Nanobiotix is that could be a trigger for Johnson & Johnson to start expanding the development. If we just stick to lung cancer, that's already a gigantic market per se. Here we're talking about stage three, but it could expand into some other indication in lung cancer. Maybe as we did not have the occasion to talk about the data that have been generated, the first part of this data, let's have a small focus on that.
Speaker #3: But if we just stick to lung cancer, that's already a gigantic market per se. Here we're talking about stage three, but it could expand into some other indication in lung cancer.
Speaker #3: And maybe, as we did not have the occasion to talk about the data that has been generated, the first part of this data, let's have a small focus on that.
Speaker #3: As I mentioned , we're talking here about patients that have a locally advanced unresectable stage three lung cancer , and their treatment of reference is radiation , chemo , followed by consolidation , consolidation , consolidations .
Laurent Levy: As I mentioned, we're talking here about patients that have a locally advanced unresectable stage 3 lung cancer, and their treatment of reference is radiation plus chemo, followed by consolidation with durvalumab. As you can see, if you look left and right of this box, many other patients in lung cancer would receive radiation therapy frontline treatment, which could be at some point an extension of the use of this product, assuming that this trial reads positive. What's the design of the trial? There's 2 parts in it. First, a safety lead-in with very few patients, and then, what we call a proof of concept with a randomized part of the trial where we compare the standard of care, chemoradiation with durvalumab, versus the same plus the product with two different doses. It is randomized 1-to-1-to-1. Total should have 120 patients.
Laurent Levy: As I mentioned, we're talking here about patients that have a locally advanced unresectable stage 3 lung cancer, and their treatment of reference is radiation plus chemo, followed by consolidation with durvalumab. As you can see, if you look left and right of this box, many other patients in lung cancer would receive radiation therapy frontline treatment, which could be at some point an extension of the use of this product, assuming that this trial reads positive. What's the design of the trial? There's 2 parts in it. First, a safety lead-in with very few patients, and then, what we call a proof of concept with a randomized part of the trial where we compare the standard of care, chemoradiation with durvalumab, versus the same plus the product with two different doses. It is randomized 1-to-1-to-1. Total should have 120 patients.
Speaker #3: With Mab . And as you can see , if you look left and right of this box , many of the patients in lung cancer would receive radiation therapy , frontline treatment , which could be at some point an expansion of the use of this product .
Speaker #3: Assuming that this trial reached positive . So what's the design of the trial ? There's two parts in it . First , a safety leading with very few patients and then what we would call a proof of concept with a randomized part of the trial where we compare the standard of care , chemo , radiation with Jehovah versus the same plus the product with two different doses .
Speaker #3: And this is randomized one to 1 to 1 total should have 120 patients . And Johnson and Johnson published that they should expect the readout of the randomized , randomized part beginning of 2027 .
Laurent Levy: Johnson & Johnson published that they should expect the readout of the randomized part beginning of 2027. The data that have been presented this week are about the safety lead-in. There's a lot of caveat around that. It's a small number of patients, but nevertheless, we can start looking at what we observed here. We've been first showing a good safety profile with no serious adverse events linked to the treatment or the procedure, and a feasibility of injection in every patient. What has been observed is a good first rate of response that we could see as we've seen five out of seven patients responding. Equally importantly, we get 100% disease control, meaning that all those patients will go or went to durvalumab, which is not the case if you look at the details of PACIFIC trial.
Laurent Levy: Johnson & Johnson published that they should expect the readout of the randomized part beginning of 2027. The data that have been presented this week are about the safety lead-in. There's a lot of caveat around that. It's a small number of patients, but nevertheless, we can start looking at what we observed here. We've been first showing a good safety profile with no serious adverse events linked to the treatment or the procedure, and a feasibility of injection in every patient. What has been observed is a good first rate of response that we could see as we've seen five out of seven patients responding. Equally importantly, we get 100% disease control, meaning that all those patients will go or went to durvalumab, which is not the case if you look at the details of PACIFIC trial.
Speaker #3: The data that have been presented this week are about the safety leading . So there's a lot of caveats around that . It's a small number of patients , but nevertheless , we can start looking at what we observe here .
Speaker #3: So, we will first show a good safety profile, with no serious adverse events linked to the treatment or the procedure, and a feasibility of injection every year.
Speaker #3: Patient . Then what has been observed is a good first rate of response that we could see . As we've seen , five out of seven patients responding and equally importantly , we get 100% disease control , meaning that all those patients will go went to a your Mab , which is not the case .
Speaker #3: If you look at the details of Pacific trial , many patients have been excluded . Post-radiation chemo for different reasons , including progression post radiation and chemo , which we did not observe so far in in this clinical trial .
Laurent Levy: Many patients have been excluded post radiation chemo for different reasons, including progression post radiation and chemo, which we did not observe so far in this clinical trial. Altogether, what we can say is a first readout encouraging, and we can wait to see the next steps of this safety lead-in or the final data that should come, as we mentioned, beginning of 2027. We can say we've been progressing a lot with this collaboration. Also, now that we have transferred the Phase 3 to J&J, they are running most of the operation. We're still running and finishing the Study 1100 trial that has completed in terms of recruitment. Now there is some follow-up of patients, and we will continue to deliver some data in that regard.
Laurent Levy: Many patients have been excluded post radiation chemo for different reasons, including progression post radiation and chemo, which we did not observe so far in this clinical trial. Altogether, what we can say is a first readout encouraging, and we can wait to see the next steps of this safety lead-in or the final data that should come, as we mentioned, beginning of 2027. We can say we've been progressing a lot with this collaboration. Also, now that we have transferred the Phase 3 to J&J, they are running most of the operation. We're still running and finishing the Study 1100 trial that has completed in terms of recruitment. Now there is some follow-up of patients, and we will continue to deliver some data in that regard.
Speaker #3: But altogether, what we can say is it's a first readout—encouraging. And we can wait to see the next steps of this safety leading or the final data that should come, as we mentioned, beginning of 2027.
Speaker #3: So, we can say we've been progressing a lot with this collaboration. Also, now that we have transferred the phase three to JNJ, they're running most of the operation.
Speaker #3: We are still running and finishing the 1100 trial that has completed in terms of recruitment. Now, there is some follow-up of patients, and we will continue to deliver some data in that regard.
Speaker #3: And the collaboration with MD Anderson Cancer Center is still ongoing, with many trials that have been completed in terms of recruitment. Last year, we're going to see data this year, and we may open to new trials with MD Anderson Cancer Center.
Laurent Levy: The collaboration with MD Anderson Cancer Center is still ongoing, with many trials that have been completed in terms of recruitment last year, where we're going to see data this year, and we may open to new trials with MD Anderson Cancer Center. Maybe let's take time to talk a little about our new platform, Curadigm. Here, we're still talking about nanophysics. We're still talking about nanoparticle, but with a different perspective, with different particle, with different potential benefit to the patient. Just as a reminder for those that are new on the call, as I see many, Curadigm is about trying to help many of the innovations we see in the biotech and the pharma arena. You can notice that most of the new innovation coming out is people are building more and more complex objects.
Laurent Levy: The collaboration with MD Anderson Cancer Center is still ongoing, with many trials that have been completed in terms of recruitment last year, where we're going to see data this year, and we may open to new trials with MD Anderson Cancer Center. Maybe let's take time to talk a little about our new platform, Curadigm. Here, we're still talking about nanophysics. We're still talking about nanoparticle, but with a different perspective, with different particle, with different potential benefit to the patient. Just as a reminder for those that are new on the call, as I see many, Curadigm is about trying to help many of the innovations we see in the biotech and the pharma arena. You can notice that most of the new innovation coming out is people are building more and more complex objects.
Speaker #3: But maybe let's take time to talk a little about our new platform here . We're still talking about Nanophysics . We're still talking about nanoparticle , but with a different perspective , with different particle , with different potential benefit to the patient .
Speaker #3: Just as a reminder for those that are new on the call, as I see many, Paradigm is about trying to help many of the innovations we see in the biotech and pharma arena.
Speaker #3: You can notice that most of the new innovation coming out people are building more and more complex objects . We can talk about oncolytic virus , RNA based therapy in vivo , Car-T cell therapies , and all the subjects , because being complex , at some point when you try to inject , inject them , I've the liver will play a role of filter and will capture a big part of them .
Laurent Levy: We can talk about oncolytic virus, RNA-based therapy, in vivo CAR-T, cell therapies, and all the subjects, because being complex, at some point, when you try to inject them IV, the liver will play a role of filter and will capture a big part of them, if not all in certain cases. For many of these innovations, it's very hard to have access to the entire body with a normal IV route. Rather than doing what our industry is usually doing, which is let's try to tweak this subject to make it more efficient and try to escape the liver while delivering at the right place, while delivering the payload and get the good transduction, for example. You're building a lot of compromises in one object. With the Curadigm technology, we decided to build what we call a Nanoprimer, a second object.
Laurent Levy: We can talk about oncolytic virus, RNA-based therapy, in vivo CAR-T, cell therapies, and all the subjects, because being complex, at some point, when you try to inject them IV, the liver will play a role of filter and will capture a big part of them, if not all in certain cases. For many of these innovations, it's very hard to have access to the entire body with a normal IV route. Rather than doing what our industry is usually doing, which is let's try to tweak this subject to make it more efficient and try to escape the liver while delivering at the right place, while delivering the payload and get the good transduction, for example. You're building a lot of compromises in one object. With the Curadigm technology, we decided to build what we call a Nanoprimer, a second object.
Speaker #3: If not all in certain cases. So for many of those innovations, it's very hard to have access to the entire body with a normal IV route.
Speaker #3: So rather than doing what our industry is usually doing, which is, let's try to tweak this object to make it more efficient and try to escape the liver while delivering at the right place, while delivering the payload, and get the good transfection, for example.
Speaker #3: So you're building a lot of compromise in one object with the technology. We decided to build what we call a nano primer, a solid object.
Speaker #3: This nano primer is injected prior to the southern product, and this nano primer has been specifically designed to transiently get into the liver and get it occupied for a certain amount of time.
Laurent Levy: This Nanoprimer is injected prior to the second product, and this Nanoprimer has been specifically designed to temporarily get into the liver and get it occupied for a certain amount of time. While the liver is busy, when you inject the second product, then it is much less captured by the liver and can have access to many other organs in the body. What you could do with this approach is improving pharmacokinetics of a product, allowing when it's not possible to escape the liver, reducing liver toxicity, or combination of all this. There are many, many opportunities and many, many applications we could do with this technology. Now a big part of the team is focused on the development of it.
Laurent Levy: This Nanoprimer is injected prior to the second product, and this Nanoprimer has been specifically designed to temporarily get into the liver and get it occupied for a certain amount of time. While the liver is busy, when you inject the second product, then it is much less captured by the liver and can have access to many other organs in the body. What you could do with this approach is improving pharmacokinetics of a product, allowing when it's not possible to escape the liver, reducing liver toxicity, or combination of all this. There are many, many opportunities and many, many applications we could do with this technology. Now a big part of the team is focused on the development of it.
Speaker #3: So why is the liver busy? When you inject a certain product, then it's much less captured by the liver and can have access to many other organs in the body.
Speaker #3: So what you could do with this approach is improve the pharmacokinetics of a product, allowing, when it's not possible to escape the liver, reducing liver toxicity, or a combination of all these.
Speaker #3: So, there are many, many opportunities and many, many applications we could do with this technology. And now a big part of the team is focused on the development of it.
Speaker #3: What we've been doing lately is really continuing , pushing , meaning filing for , for new patents , application to continue to build our supremacy with this technology .
Laurent Levy: What we've been doing lately is really continuing pushing, meaning filing for 4 new patent applications to continue to build our supremacy with this technology. We also have presented positive new in vivo preclinical combination with different type of combination. More importantly, we are moving forward toward the IND, and we've started the CMC activity with the start of the GMP manufacturing and also the preclinical studies allowing to file for an IND. While doing that with the internal program at Nano, we've been extending a lot our external reach out. We have now more than 20 MTAs that we've been signing with pharma or biotech, where they have taken our product and they are testing it with one of their products to either improving the pharmacokinetics of this product or reducing liver toxicity.
Laurent Levy: What we've been doing lately is really continuing pushing, meaning filing for 4 new patent applications to continue to build our supremacy with this technology. We also have presented positive new in vivo preclinical combination with different type of combination. More importantly, we are moving forward toward the IND, and we've started the CMC activity with the start of the GMP manufacturing and also the preclinical studies allowing to file for an IND. While doing that with the internal program at Nano, we've been extending a lot our external reach out. We have now more than 20 MTAs that we've been signing with pharma or biotech, where they have taken our product and they are testing it with one of their products to either improving the pharmacokinetics of this product or reducing liver toxicity.
Speaker #3: We also have presented positive new in vivo pre-clinical combination with different types of combination, and more importantly, we are moving forward toward the end.
Speaker #3: And we've started the CMC activity with the start of the GMP manufacturing and also the pre-clinical studies allowing to file for an IND, and while doing that, the internal program at Nano will be extending a lot or external reach out.
Speaker #3: We have now more than 20 MTAs that we've been signing with pharma or biotech, where they have taken our product and they are testing it with one of their products to either improve the pharmacokinetics of this product or reduce liver toxicity.
Speaker #3: And we've done that with many different technologies for different therapeutic areas like oncology, rare disease, and CNS disorder. So it's moving quite well.
Laurent Levy: We've done that with many different technologies for different therapeutic areas like oncology, rare disease, CNS disorder. It's moving quite well. We expect in the not-too-distant future to start transforming some of those NTAs into deals. Globally, the way we see the value of this platform and the three pillars that we are using to push it is first, continue to build and protect the technology while building an internal pipeline. We want to have our fully owned product to be developed up to a certain stage while we are building or planning up deals with different partner, pharma, and biotech. Of course, because of all this, we need to prioritize and build the right infrastructure to be able to build, to manufacture, and to provide this product to many partner and to our internal pipeline.
Laurent Levy: We've done that with many different technologies for different therapeutic areas like oncology, rare disease, CNS disorder. It's moving quite well. We expect in the not-too-distant future to start transforming some of those NTAs into deals. Globally, the way we see the value of this platform and the three pillars that we are using to push it is first, continue to build and protect the technology while building an internal pipeline. We want to have our fully owned product to be developed up to a certain stage while we are building or planning up deals with different partner, pharma, and biotech. Of course, because of all this, we need to prioritize and build the right infrastructure to be able to build, to manufacture, and to provide this product to many partner and to our internal pipeline.
Speaker #3: And then we expect, in the not too distant future, to start transforming some of those MTAs into deals. But we do believe the way we see the value of this platform, and the three pillars that we are using to push it, is first, continue to build and protect the technology while building an internal pipeline.
Speaker #3: We want to have our fully owned product to be developed up to a certain stage . While we are building our piling up deal with different partner pharma and biotech .
Speaker #3: And of course, because of all this, we need to prioritize and build the right infrastructure to be able to build, to manufacture, and to provide this product to many partners and to our internal pipeline.
Speaker #3: So, things are moving well, and we expect to get a bit more updates and new data on this platform coming before the end of the summer.
Laurent Levy: Things are moving well, and we expect to get a bit more update and new data on this platform coming before the end of the summer. Just of note, last year, we've been entering a new index on the Euronext market, which is the SBF 120, and that's an index that covers the 120 largest French-listed company by market cap, liquidity. It does give us a bit more institutional visibility, and we've seen through that some of the new investors coming on top of specialized biotech investors that have entered our stock last year. I'm gonna take this to give the mic to Bart to talk about the financial part of this presentation.
Laurent Levy: Things are moving well, and we expect to get a bit more update and new data on this platform coming before the end of the summer. Just of note, last year, we've been entering a new index on the Euronext market, which is the SBF 120, and that's an index that covers the 120 largest French-listed company by market cap, liquidity. It does give us a bit more institutional visibility, and we've seen through that some of the new investors coming on top of specialized biotech investors that have entered our stock last year. I'm gonna take this to give the mic to Bart to talk about the financial part of this presentation.
Speaker #3: Just of note , last year , we we've been entering a new index on the Euronext market , which is the SDF . 120 and that's an index that covers the 120 largest French listed company by market and cap liquidity .
Speaker #3: So it does give us a bit more institutional visibility. And we've seen through that some of the new industrials coming on, on top of specialized biotech investors that have entered our stock last year.
Speaker #3: And I'm going to take this to give the mic to Bob to talk about the financial part of this presentation. Thank you, Laura.
Bart Van Rhijn: Thank you, Laurent. Good morning, good afternoon, everyone, and thank you for joining us today. Over the past year, we've materially strengthened the company's financial foundation, positioning us to advance to upcoming value inflection points with greater resilience and strategic flexibility. This progress was supported by 2 strategic initiatives that meaningfully reshaped our capital requirements and hence our long-term operating flexibility. First, we amended our global licensing agreement with Janssen in a way that materially improves our financial profile. Under the revised terms, we have removed the vast majority of our funding obligations for the Phase 3 NANORAY-312 study, while retaining significant upside through milestone payments that could total hundreds of millions EUR over the next 24 to 36 months. This amendment materially enhances capital efficiency, improves cash flow visibility, and better aligns the partnership structure with our long-term strategic priorities.
Bart Van Rhijn: Thank you, Laurent. Good morning, good afternoon, everyone, and thank you for joining us today. Over the past year, we've materially strengthened the company's financial foundation, positioning us to advance to upcoming value inflection points with greater resilience and strategic flexibility. This progress was supported by 2 strategic initiatives that meaningfully reshaped our capital requirements and hence our long-term operating flexibility. First, we amended our global licensing agreement with Janssen in a way that materially improves our financial profile. Under the revised terms, we have removed the vast majority of our funding obligations for the Phase 3 NANORAY-312 study, while retaining significant upside through milestone payments that could total hundreds of millions EUR over the next 24 to 36 months. This amendment materially enhances capital efficiency, improves cash flow visibility, and better aligns the partnership structure with our long-term strategic priorities.
Speaker #4: Good morning and good afternoon , everyone , and thank you for joining us today Over the past year , we've materially strengthened the company's financial foundation , positioning us to advance to upcoming value inflection points with greater resilience and strategic flexibility .
Speaker #4: This progress was supported by two strategic initiatives that meaningfully reshaped our capital requirements , enhanced our long term operating flexibility . First , we amended our global licensing agreement with Jensen in a way that materially improves our financial profile under the revised terms , we have removed the vast majority of our funding obligations for the phase three nano 312 study .
Speaker #4: While retaining significant upside through milestone payments that could total hundreds of millions of euros over the next 24 to 36 months . This amendment materially enhances capital efficiency , improves cash flow visibility , and better aligns the partnership structure with our long term strategic priorities .
Speaker #4: Second, we strengthened our balance sheet through the securing of a non-dilutive royalty financing with Healthcare Royalty Partners for up to $71 million.
Bart Van Rhijn: Second, we strengthened our balance sheet to the securing of a non-dilutive royalty financing with HealthCare Royalty Partners for up to $71 million. This transaction provides incremental capital while avoiding shareholder dilution, extends our projected cash runway into early 2028, excluding potential milestone inflows. Taking together the strategic initiatives that I just outlined enhance our financial flexibility, reduce near-term funding requirements, and position the company to sustainably advance its pipeline while maintaining a disciplined approach to capital allocation and long-term value creation. Turning to the next slide. Just a brief overview of the deal we announced back in October. We're extremely pleased to have partnered with HealthCare Royalty Partners on this transaction, bringing up to $71 million of non-dilutive capital into the company.
Bart Van Rhijn: Second, we strengthened our balance sheet to the securing of a non-dilutive royalty financing with HealthCare Royalty Partners for up to $71 million. This transaction provides incremental capital while avoiding shareholder dilution, extends our projected cash runway into early 2028, excluding potential milestone inflows. Taking together the strategic initiatives that I just outlined enhance our financial flexibility, reduce near-term funding requirements, and position the company to sustainably advance its pipeline while maintaining a disciplined approach to capital allocation and long-term value creation. Turning to the next slide. Just a brief overview of the deal we announced back in October. We're extremely pleased to have partnered with HealthCare Royalty Partners on this transaction, bringing up to $71 million of non-dilutive capital into the company.
Speaker #4: This transaction provides incremental capital while avoiding shareholder dilution , extends our projected cash runway into early 2028 . Excluding potential milestone inflows Taken together , this Tajik initiatives that are just outlined enhance our financial flexibility , reduce near-term funding requirements , and position the company to sustainably advance its pipeline while maintaining a disciplined approach to capital allocation and long term value creation Turning to the next slide .
Speaker #4: Just a brief overview of the deal. We announced back in October, we're extremely pleased to have partnered with Healthcare Royalty Partners on this transaction, bringing up to $71 million of non-dilutive capital into the company.
Speaker #4: We selected Healthcare Royalty Partners following a comprehensive evaluation of financing alternatives and given their deep sector experience and expertise, long-term investment outlook, and strong record of supporting innovative biotech companies.
Bart Van Rhijn: We selected HealthCare Royalty Partners following a comprehensive evaluation of financing alternatives, and given their deep sector experience and expertise, long-term investment outlook, and strong record of supporting innovative biotech companies, we selected to partner with them. We believe that this partnership reflects the high degree of alignment around the long-term potential of JNJ-1900 and our broader strategic objectives. Critically, this royalty structure ensures that our partner's return is directly linked to the success of our lead program, which aligns incentives while avoiding repayment obligations beyond the nominal value of the bonds. Moreover, this is a construct that is kept from a time and amount perspective, and therefore a capital efficient way to finance the company beyond anticipated value inflection points to ensure we maximize the value for our shareholders.
Bart Van Rhijn: We selected HealthCare Royalty Partners following a comprehensive evaluation of financing alternatives, and given their deep sector experience and expertise, long-term investment outlook, and strong record of supporting innovative biotech companies, we selected to partner with them. We believe that this partnership reflects the high degree of alignment around the long-term potential of JNJ-1900 and our broader strategic objectives. Critically, this royalty structure ensures that our partner's return is directly linked to the success of our lead program, which aligns incentives while avoiding repayment obligations beyond the nominal value of the bonds. Moreover, this is a construct that is kept from a time and amount perspective, and therefore a capital efficient way to finance the company beyond anticipated value inflection points to ensure we maximize the value for our shareholders.
Speaker #4: We selected to partner with them . We believe that this partnership reflects a high degree of alignment around the long term potential of JNJ 1900s , and our broader , broader strategic objectives .
Speaker #4: Critically, this royalty structure ensures that our partner's return is directly linked to the success of our lead program, which aligns incentives while avoiding repayment obligations beyond the nominal value of the bonds.
Speaker #4: Moreover, this is a construct that is kept from a time and amount perspective, and therefore a capital-efficient way to finance the company beyond anticipated value.
Speaker #4: Inflection points to ensure we maximize the value for our shareholders . This financing not only ensures we are funded through those critical inflection points , but validates the commercial potential of JNJ 1900 and supports our continued progress toward long term sustainability and profitability Moving over to our full year financial highlights for the full year 2025 , we recognized positive revenue of €32.6 million compared to -€7.2 million .
Bart Van Rhijn: This financing not only ensures we are funded through those critical inflection points, but validates the commercial potential of JNJ-1900 and supports our continued progress toward long-term sustainability and profitability. Moving over to our full-year financial highlights. For the full year 2025, we recognized revenue of EUR +32.6 million compared to EUR -7.2 million for the year ended 2024. As a reminder, the negative revenue recorded in 2024 was primarily driven by a one-time recognition of the net liability to Janssen following the transfer of the sponsorship of the NANORAY-312 study. The positive revenue recognized in 2025 reflects a one-time accounting impact of EUR 21.8 million, associated with the amendments to a licensing agreement that we executed in March 2025.
Bart Van Rhijn: This financing not only ensures we are funded through those critical inflection points, but validates the commercial potential of JNJ-1900 and supports our continued progress toward long-term sustainability and profitability. Moving over to our full-year financial highlights. For the full year 2025, we recognized revenue of EUR +32.6 million compared to EUR -7.2 million for the year ended 2024. As a reminder, the negative revenue recorded in 2024 was primarily driven by a one-time recognition of the net liability to Janssen following the transfer of the sponsorship of the NANORAY-312 study. The positive revenue recognized in 2025 reflects a one-time accounting impact of EUR 21.8 million, associated with the amendments to a licensing agreement that we executed in March 2025.
Speaker #4: For the year ended 2020 . For . As a reminder , the negative revenue recorded in 2024 was primarily driven by a one time recognition of the net liability to Janssen following the transfer of the sponsorship of the nano three trial study The positive revenue recognized in 2025 reflects a one time accounting impact of €21.8 million associated with the amendments to a licensing agreement that we executed in March 2025 .
Speaker #4: This amendment , as alluded to earlier , eliminated the vast majority of the company's development cost obligations related to the nano ray . 312 study .
Bart Van Rhijn: This amendment, as Laurent alluded to earlier, eliminated the vast majority of the company's development cost obligations related to the NANORAY-312 study. This technical accounting effect, related to the transfer of sponsorship and the cancellation of current and future study-related costs, resulted in a corresponding impact on our reported top line, which is non-recurring. Said differently, as these changes in 2024 and 2025 are considered purchase price adjustments from an accounting point of view, these results flow through the revenue line in our profit and loss account. Let us turn to R&D expenses. These include clinical and manufacturing expenses related to the development of JNJ-1900 and pre-clinical pipeline activities, and totaled EUR 23.1 million for the twelve-month period ended 31 December 2025. Which compares to EUR 14.5 million for the twelve months ended 31 December 2024.
Bart Van Rhijn: This amendment, as Laurent alluded to earlier, eliminated the vast majority of the company's development cost obligations related to the NANORAY-312 study. This technical accounting effect, related to the transfer of sponsorship and the cancellation of current and future study-related costs, resulted in a corresponding impact on our reported top line, which is non-recurring. Said differently, as these changes in 2024 and 2025 are considered purchase price adjustments from an accounting point of view, these results flow through the revenue line in our profit and loss account. Let us turn to R&D expenses. These include clinical and manufacturing expenses related to the development of JNJ-1900 and pre-clinical pipeline activities, and totaled EUR 23.1 million for the twelve-month period ended 31 December 2025. Which compares to EUR 14.5 million for the twelve months ended 31 December 2024.
Speaker #4: This technical accounting effect related to the transfer of sponsorship and the cancellation of current and future study-related costs resulted in a corresponding impact on our reported top line, which is non-recurring.
Speaker #4: Said differently, as these changes in 2024 and 2025 are considered purchase price adjustments from an accounting point of view, these results flow through the revenue line in our profit and loss account. Let us turn to R&D expenses.
Speaker #4: These include clinical and manufacturing expenses related to the development of JNJ 1900 and preclinical pipeline activities , and totaled €23.1 million for the 12 month period ended December 31st , 2025 , which compares to €40.5 million for the 12 months ended December 31st , 2024 .
Speaker #4: As previously discussed, the significant year-over-year decrease of approximately 43% was primarily driven by the removal of development costs associated with the NANO 312 study following the transfer of sponsorship to Janssen.
Bart Van Rhijn: As previously discussed, the significant year-over-year decrease of approximately 43% was primarily driven by the removal of development costs associated with the NANORAY-312 study following the transfer of sponsorship to Janssen. This transition resulted in the elimination of related clinical and operational expenditures previously borne by the company. More broadly, R&D spending during the period reflects continued prioritization of capital efficient development across our clinical and pre-clinical programs, while maintaining investment in key manufacturing and pipeline activities, supporting the long term advancement of our auto platforms that Laurent just spoke to. Selling general and administrative expense for the twelve-month period ended 31 December 2025 were flat to slightly down year-over-year at EUR 20.4 million compared to EUR 20.5 million, reflecting continued expense control.
Bart Van Rhijn: As previously discussed, the significant year-over-year decrease of approximately 43% was primarily driven by the removal of development costs associated with the NANORAY-312 study following the transfer of sponsorship to Janssen. This transition resulted in the elimination of related clinical and operational expenditures previously borne by the company. More broadly, R&D spending during the period reflects continued prioritization of capital efficient development across our clinical and pre-clinical programs, while maintaining investment in key manufacturing and pipeline activities, supporting the long term advancement of our auto platforms that Laurent just spoke to. Selling general and administrative expense for the twelve-month period ended 31 December 2025 were flat to slightly down year-over-year at EUR 20.4 million compared to EUR 20.5 million, reflecting continued expense control.
Speaker #4: This transition resulted in the elimination of related clinical and operational expenditures previously borne by the company. More broadly, R&D spending during the period reflects continued prioritization of capital-efficient development across our clinical and pre-clinical programs.
Speaker #4: While maintaining investment in key manufacturing and pipeline activities supporting the long term advancement of our auto platforms . That Vermont just spoke to selling , general and administrative expense for the 12 month period ended December 31st , 2025 were flat to significantly .
Speaker #4: Sorry to slightly down year over year at €20.4 million , compared to €20.5 million , reflecting continued expense control , net loss attributable to was €24 million , or €50 cents per share , for the 12 month period ended December 31st , 2025 , reflecting a year over year decrease of 65% .
Bart Van Rhijn: Net loss attributable to shareholders was EUR 24 million or EUR 0.50 per share for the twelve-month period ended 31 December 2025, reflecting a year-over-year decrease of 65%. The decrease was primarily attributable to one-off non-cash positive revenue recognition accounting impact, together with a meaningful decrease in R&D expense resulting from the removal of the funding obligation for the 312 study. This compares to a net loss of EUR 68.1 million or EUR 1.44 per share recorded for the same period last year. As we turn to cash and cash equivalents, as of 31 December 2025, that amounted to EUR 52.8 million compared to EUR 49.7 million as of 31 December 2024.
Bart Van Rhijn: Net loss attributable to shareholders was EUR 24 million or EUR 0.50 per share for the twelve-month period ended 31 December 2025, reflecting a year-over-year decrease of 65%. The decrease was primarily attributable to one-off non-cash positive revenue recognition accounting impact, together with a meaningful decrease in R&D expense resulting from the removal of the funding obligation for the 312 study. This compares to a net loss of EUR 68.1 million or EUR 1.44 per share recorded for the same period last year. As we turn to cash and cash equivalents, as of 31 December 2025, that amounted to EUR 52.8 million compared to EUR 49.7 million as of 31 December 2024.
Speaker #4: The decrease was primarily attributable to the one off non-cash positive revenue recognition accounting impact . Together with the meaningful decrease in R&D expense resulting from the removal of the funding obligation for the 312 study , this compares to a net loss of €68.1 million , or €1.44 per share , recorded for the same period last year .
Speaker #4: As we turn to cash and cash equivalents as of December 31st , 2025 , that amounted to €52.8 million , compared to €49.7 million as of December 31st , 2024 .
Speaker #4: Based on the current operating plan and financial projections, Nanobiotix S.A. anticipates that the cash and cash equivalents of €52.8 million as of December 31, 2025, will fund its operations into early 2028.
Bart Van Rhijn: Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of EUR 52.8 million as of 31 December 2025 will fund its operations into early 2028, assuming the receipt of the remaining $21 million from HealthCare Royalty Partners expected in Q4 of 2026. To conclude, we remain focused on disciplined execution as we advance through key clinical and strategic milestones. We will continue to prioritize prudent capital allocation, operational efficiency, and balance sheet resiliency, and believe the foundation we have built positions us well for the periods ahead as we work to deliver long-term value for our stakeholders. Thank you. Now I would like to turn the call back to Laurent.
Bart Van Rhijn: Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of EUR 52.8 million as of 31 December 2025 will fund its operations into early 2028, assuming the receipt of the remaining $21 million from HealthCare Royalty Partners expected in Q4 of 2026. To conclude, we remain focused on disciplined execution as we advance through key clinical and strategic milestones. We will continue to prioritize prudent capital allocation, operational efficiency, and balance sheet resiliency, and believe the foundation we have built positions us well for the periods ahead as we work to deliver long-term value for our stakeholders. Thank you. Now I would like to turn the call back to Laurent.
Speaker #4: Assuming the receipt of the remaining $21 million from healthcare royalty partners expected in Q4 of 2026. To conclude, we remain focused on disciplined execution as we advance to key clinical and strategic milestones.
Speaker #4: We will continue to prioritize prudent capital allocation, operational efficiency, and balance sheet resiliency, and believe the foundation we have built positions us well for the periods ahead.
Speaker #4: As we work to deliver long-term value for our stakeholders. Thank you. And now I'd like to turn the call back to Laurent.
Speaker #3: Thank you, Bob. Just in a nutshell, what's coming for the next 12 to 18 months in front of us: we will continue to push with our new platform and will continue to deliver new data, and also our visibility on how we're going to transform that into business.
Laurent Levy: Thank you, Babs. Just in a nutshell, what's coming for the 12, 18 months in front of us. We will continue to push with our new platform, Curadigm, and we'll continue to deliver new data and also visibility on how we're gonna transform that into business. On top of that, the NBTXR3 or JNJ-1900 development is still key in our development, as should be the critical next step for value creation, as we expect to get the result of the Phase 3 in H1 2027 and the result of the Phase 2 in lung cancer in early 2027. Besides this year we're gonna deliver 4 different results of clinical trial, which 3 of them have been completed, so you'll be able to see the final data for this.
Laurent Levy: Thank you, Babs. Just in a nutshell, what's coming for the 12, 18 months in front of us. We will continue to push with our new platform, Curadigm, and we'll continue to deliver new data and also visibility on how we're gonna transform that into business. On top of that, the NBTXR3 or JNJ-1900 development is still key in our development, as should be the critical next step for value creation, as we expect to get the result of the Phase 3 in H1 2027 and the result of the Phase 2 in lung cancer in early 2027. Besides this year we're gonna deliver 4 different results of clinical trial, which 3 of them have been completed, so you'll be able to see the final data for this.
Speaker #3: On top of that, the NBTXR3 or 1900 development is still key in our development, as should be the critical next step for value creation.
Speaker #3: As we expect to get the results of the Phase 3 in the first half of ’27, and the results of the Phase 2 in lung cancer in early 2027.
Speaker #3: Beside this , this year we're going to deliver for different results of clinical trial , which three of them have been completed . So you'll be able to see the final data for for this , the key takeaway for today , if we think about 2025 and what's coming is the Genghis partnership and the development of Nbtxr3 is moving in the right direction with amplification of the development through multiple trials , we've continued to show that potential use of Nbtxr3 across different indications , which reinforcing the potential value of this product .
Laurent Levy: The key takeaway for today, if we think about 2025 and what's coming, is Janssen's partnership and the development of NBTXR3 is moving in the right direction with amplification of the development through multiple trials. We've continued to show that potential use of NBTXR3 across different indications, which is reinforcing the potential value of this product. As mentioned, we've continued the Curadigm development, a new class of drugs that we intend to bring to life. As Babs just mentioned, we're getting in a good financial position as our cash visibility is going into 2028 beyond key milestone in head and neck and lung and potentially other milestones. As you have just seen, we have multiple near-term data readouts that could continue to show, assuming it's positive, that NBTXR3 could really improve life of millions of patients. Thank you very much for your attention.
Laurent Levy: The key takeaway for today, if we think about 2025 and what's coming, is Janssen's partnership and the development of NBTXR3 is moving in the right direction with amplification of the development through multiple trials. We've continued to show that potential use of NBTXR3 across different indications, which is reinforcing the potential value of this product. As mentioned, we've continued the Curadigm development, a new class of drugs that we intend to bring to life. As Babs just mentioned, we're getting in a good financial position as our cash visibility is going into 2028 beyond key milestone in head and neck and lung and potentially other milestones. As you have just seen, we have multiple near-term data readouts that could continue to show, assuming it's positive, that NBTXR3 could really improve life of millions of patients. Thank you very much for your attention.
Speaker #3: And as mentioned, we've continued the paradigm development. A new class of drug that we intend to bring to life, as Bob just mentioned. We are getting in a good financial position, as our cash visibility is going into 2028.
Speaker #3: Beyond key milestones in head and neck and lung and potentially other milestones . And as you have just seen , we have multiple near-term data readouts that could continue to show , assuming it's positive , that Nbtxr3 could really improve lives of millions of patients .
Speaker #3: Thank you very much for your attention. And now we're going to open the call for questions.
Laurent Levy: Now we're going to open the call for questions.
Laurent Levy: Now we're going to open the call for questions.
Speaker #1: Thank you . As a reminder to ask a question , you will need to press star one one on your telephone and wait for your name to be announced to withdraw your question , please press star one one again We will take our first question .
Operator: Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We will take our first question. Your first question comes from the line of Tara Bancroft from TD Cowen. Please go ahead. Your line is open.
Operator: Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We will take our first question. Your first question comes from the line of Tara Bancroft from TD Cowen. Please go ahead. Your line is open.
Speaker #1: Your first question comes from the line of Tara Bancroft from TD Cohen. Please go ahead, your line is open.
Speaker #5: Hi. Good morning or good afternoon to you guys. So, my question is about the long data that you guys showed from Converge yesterday.
Tara Bancroft: Hi. Good morning or good afternoon for you guys. My question is about, you know, the lung data that you guys showed from CONVERGE yesterday. They were really interesting, even if only in the first seven patients. We were hoping you could give us some context for how you benchmarked that to the 45% to 50% ORR. We ask because PACIFIC seems to be the best comp here, where ORR was actually around 30%. Just curious to hear your thoughts on that. Then on follow-up, when were these assessments taken that were in the poster? And how does that length of follow-up so far play into your level of confidence in the data that could potentially improving even further in part two? Thanks so much.
Tara Bancroft: Hi. Good morning or good afternoon for you guys. My question is about, you know, the lung data that you guys showed from CONVERGE yesterday. They were really interesting, even if only in the first seven patients. We were hoping you could give us some context for how you benchmarked that to the 45% to 50% ORR. We ask because PACIFIC seems to be the best comp here, where ORR was actually around 30%. Just curious to hear your thoughts on that. Then on follow-up, when were these assessments taken that were in the poster? And how does that length of follow-up so far play into your level of confidence in the data that could potentially improving even further in part two? Thanks so much.
Speaker #5: They were really interesting, even if only in the first seven patients. So, we were hoping you could give us some context for how you benchmarked that to the 45% to 50% IRR.
Speaker #5: We asked because specific seems to be the best comp here . We're or was actually around 30% . So just curious to hear your thoughts on that .
Speaker #5: And then on follow up , when were these assessments taken that were in the poster ? And , and how does that length of follow up so far ?
Speaker #5: Play into your level of confidence in the data that potentially improving even further in part two? Thanks so much.
Speaker #3: Thank you, Sara. Well, I think there are a few papers or historical controls we could look at as comparators for that, as a context.
Laurent Levy: Thank you, Tara. Well, I think there are a few papers or historical controls we could look at as comparators for that. As a context, we're using the PACIFIC regimen in this trial. Patients getting radiation plus chemo, and if they do not progress, then they go to durvalumab. If you look at the PACIFIC paper, they start with 983 patients that receive radiation plus chemo. Out of that, only 70% will be randomized, two to durvalumab, one with placebo. So there is in the evaluation of the response rate in the PACIFIC paper, something telling 48% response. But that excludes the 30% patients that have been not treated after that with durvalumab. So that's the response rate they found after radiochemo.
Laurent Levy: Thank you, Tara. Well, I think there are a few papers or historical controls we could look at as comparators for that. As a context, we're using the PACIFIC regimen in this trial. Patients getting radiation plus chemo, and if they do not progress, then they go to durvalumab. If you look at the PACIFIC paper, they start with 983 patients that receive radiation plus chemo. Out of that, only 70% will be randomized, two to durvalumab, one with placebo. So there is in the evaluation of the response rate in the PACIFIC paper, something telling 48% response. But that excludes the 30% patients that have been not treated after that with durvalumab. So that's the response rate they found after radiochemo.
Speaker #3: We are using the PACIFIC regimen in this trial, and patients are getting radiation plus chemo. And if they do not progress, then they go to durvalumab.
Speaker #3: If you look at the Pacific paper , they start with 983 patients that received radiation plus chemo . And out of that , only 70% will be randomized Two patients in the direction of Jehovah , one with placebo .
Speaker #3: So there is, in the evaluation of the response rate in the PACIFIC paper, something telling 4.048% of response. But that excludes the 30% of patients that have not been treated after that with a GEO.
Speaker #3: So that's the response rate . Therefore , on after radio chemo . And if you look at the response rate , post Mab , then it's going down .
Laurent Levy: If you look at the response rate post durvalumab, then it's going down, but it's going down slower than the placebo arm. Here you'll find the 27% response that you probably mentioned. Again, this 27% response is excluding the patient that had been frontline excluded from the trial before randomization. Altogether, if we take 40-50%, that's what we can find in some other paper as what radiation plus chemo is doing for those patients and close to what they find as an optimization in the PACIFIC regimen. I think that's just the first part. The most important part is how this evolves over time. Because what we see in PACIFIC, some patients do not get durva, 30%, and then the rate is going down over time.
Laurent Levy: If you look at the response rate post durvalumab, then it's going down, but it's going down slower than the placebo arm. Here you'll find the 27% response that you probably mentioned. Again, this 27% response is excluding the patient that had been frontline excluded from the trial before randomization. Altogether, if we take 40-50%, that's what we can find in some other paper as what radiation plus chemo is doing for those patients and close to what they find as an optimization in the PACIFIC regimen. I think that's just the first part. The most important part is how this evolves over time. Because what we see in PACIFIC, some patients do not get durva, 30%, and then the rate is going down over time.
Speaker #3: But it is going down slower, slower than the placebo arm. And here you find the 27% response that you probably mentioned.
Speaker #3: But again , this 27% response is excluding the patient that have been frontline excluded from the trial before randomization . So altogether , if we take 4,050% , that's what we can find in some other papers as well .
Speaker #3: Radiation plus chemo is being done for those patients, and close to what they find as an optimization in the Pacific regimen. But I think that's just the first part.
Speaker #3: The most important part is how this evolves over time, because what we're seeing in Pacific, some patients do not get Jehovah, 30%.
Speaker #3: And then the rate is going down over time. So I think if our tree can provide a real local control, then we should see something different happening versus what you can observe with Durvalumab.
Laurent Levy: I think if R3 can provide a real local control, then we should see something different happening versus what you can observe with durvalumab. This will be answered a bit later and potentially definitely answered when we will see the results of the phase 2, beginning of next year.
Laurent Levy: I think if R3 can provide a real local control, then we should see something different happening versus what you can observe with durvalumab. This will be answered a bit later and potentially definitely answered when we will see the results of the phase 2, beginning of next year.
Speaker #3: But this will be answered a bit later, and potentially definitely answered when we see the results of the Phase Two, beginning of next year.
Tara Bancroft: Great. Thanks.
Tara Bancroft: Great. Thanks.
Speaker #5: Great . Thanks .
Laurent Levy: Thank you, Tara.
Laurent Levy: Thank you, Tara.
Speaker #3: Thank you . Tara .
Operator: Thank you. We will take our next question. Your next question comes from the line of Clémence Thiers from Stifel. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. Your next question comes from the line of Clémence Thiers from Stifel. Please go ahead. Your line is open.
Speaker #1: Thank you. We will take our next question. Your next question comes from the line of Clémence Tears from Stifel. Please go ahead.
Speaker #1: Your line is open .
Clémence Thiers: Thank you. Thank you for the presentation. Just to come back to the CONVERGE Study, full data will be in early 2027. Is there any chance you or JNJ could file based on the study, or do you have to run a Phase 3 afterwards? That's the first question.
Clémence Thiers: Thank you. Thank you for the presentation. Just to come back to the CONVERGE Study, full data will be in early 2027. Is there any chance you or JNJ could file based on the study, or do you have to run a Phase 3 afterwards? That's the first question.
Speaker #6: Thank you . And thank you for the presentation . Just to come back to the conversation , converge , study full data will be in early 2027 .
Speaker #6: Is there any chance you or Change could file based on the study, or do you have to run a Phase Three afterwards?
Speaker #6: That's the first question .
Laurent Levy: Hi, Clémence. Thank you for the question. Well, first of all, we can talk for our partner. Now JNJ is running the CONVERGE trial and has the license on the product. So that will be their decision. I think it's a bit early to talk about that. That may be a question we could ask when we see the data coming from the Phase 2. If the data are excellent, everything is open. Again, that would be a JNJ's decision to move that direction or to do a proper Phase 3 after that.
Laurent Levy: Hi, Clémence. Thank you for the question. Well, first of all, we can talk for our partner. Now JNJ is running the CONVERGE trial and has the license on the product. So that will be their decision. I think it's a bit early to talk about that. That may be a question we could ask when we see the data coming from the Phase 2. If the data are excellent, everything is open. Again, that would be a JNJ's decision to move that direction or to do a proper Phase 3 after that.
Speaker #3: Hi , Clemens , thank you for the question . Well , first of all , we can talk for partner JNJ . Now it's running the converge trial and has the license on the product .
Speaker #3: So, that will be their decision. And I think it's a bit early to talk about that. That may be a question we could ask when we see the data coming from the Phase Two.
Speaker #3: But if the data are excellent , everything is open . But again , that that would be a decision to to move that direction or to do a proper phase three .
Speaker #3: After that. Okay. Thank you for the best.
Clémence Thiers: Okay. Thank you.
Clémence Thiers: Okay. Thank you.
Laurent Levy: Just think of all the best.
Laurent Levy: Just think of all the best.
Clémence Thiers: Yeah, that was worth a shot. The second question, so in 2026, we'll have all those additional data sets from your Study 1100 and the MD Anderson studies. Are those the last ones in the sense that, will you be after that at a stage where you or JNJ decide whether you move forward with it or not?
Clémence Thiers: Yeah, that was worth a shot. The second question, so in 2026, we'll have all those additional data sets from your Study 1100 and the MD Anderson studies. Are those the last ones in the sense that, will you be after that at a stage where you or JNJ decide whether you move forward with it or not?
Speaker #6: Yeah, that was worth a shot. And the second question: 2026 will have all those additional data sets from your study and understand studies.
Speaker #6: Although the last ones in the sense that will you be after that at the stage where you again , JNJ decide whether you move forward with it or not ?
Laurent Levy: Yeah. I think some of those trials have been completed, like, the melanoma cancer trial, the lung re-irradiation, and the last one, esophageal cancer. Just to know that we are now looking with MD Anderson at opening some potential new trial to explore new avenues. That's something that will come a bit later. Obviously, out of all those trials, we got a lot of signs of safety, feasibility, potential good efficacy for the product. Now it's within the end of the year with J&J, but also discussing with us about potential next step, but nothing that we can say at this stage. If I have one mention to do is to maybe take a particular look at the MD Anderson Cancer trial about lung re-irradiation.
Laurent Levy: Yeah. I think some of those trials have been completed, like, the melanoma cancer trial, the lung re-irradiation, and the last one, esophageal cancer. Just to know that we are now looking with MD Anderson at opening some potential new trial to explore new avenues. That's something that will come a bit later. Obviously, out of all those trials, we got a lot of signs of safety, feasibility, potential good efficacy for the product. Now it's within the end of the year with J&J, but also discussing with us about potential next step, but nothing that we can say at this stage. If I have one mention to do is to maybe take a particular look at the MD Anderson Cancer trial about lung re-irradiation.
Speaker #3: Yeah, I think some of those trials have been completed, like the melanoma cancer trial, the lung re-irradiation, and the last one, Xofigo cancer. Just to note that we are now looking with MD Anderson at opening some potential new trials to explore new avenues.
Speaker #3: But it's something that that will come a bit later . Obviously , out of all those trials , we got a lot of signs of safety , feasibility , potential , good efficacy for the product , and now it's within the end of January , but also discussing with us about potential next steps , but nothing that we can say at this stage .
Speaker #3: If I have one mention to do, it's to maybe take a particular look at the NDA Anderson cancer trial about lung re-radiation. This trial, the recruitment has been completed.
Laurent Levy: This trial, the recruitment has been completed last year, and we'll see the final data this year on more patients with more follow-up. I think this trial is very important because it's not like the same population that is treated in CONVERGE, but to a certain extent could be seen as a surrogate of what we could observe in CONVERGE. We will pay particular attention to this trial, but also, we'll bring that to your attention.
Laurent Levy: This trial, the recruitment has been completed last year, and we'll see the final data this year on more patients with more follow-up. I think this trial is very important because it's not like the same population that is treated in CONVERGE, but to a certain extent could be seen as a surrogate of what we could observe in CONVERGE. We will pay particular attention to this trial, but also, we'll bring that to your attention.
Speaker #3: Last year, and we will see the final data this year on more patients with more follow-up. I think this trial is very important because it's not like the same population that is treated in Converge, but to a certain extent could be seen as a surrogate of what we could observe in Converge.
Speaker #3: So, we will pay particular attention to this trial, but also we'll bring that to you, to your attention.
Clémence Thiers: Okay. Thank you very much.
Clémence Thiers: Okay. Thank you very much.
Speaker #6: Okay. Thank you very much.
Laurent Levy: Thank you, Clémence Thiers.
Laurent Levy: Thank you, Clémence Thiers.
Speaker #3: Thank you
Clémence Thiers: Thank you.
Clémence Thiers: Thank you.
Operator: Thank you. We will take our next question. Your next question comes from the line of Jonathan Chang from Leerink Partners. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. Your next question comes from the line of Jonathan Chang from Leerink Partners. Please go ahead. Your line is open.
Speaker #1: Thank you. We will take our next question. Your next question comes from the line of Jonathan Chang from Leerink Partners. Please go ahead.
Speaker #1: Your line is open
Albert Agustin: Good morning, good afternoon. This is Albert Agustin on for Jonathan Chang. Congrats on all the progress, and thanks for taking my question. My question also reflects on the CONVERGE data. How do we extrapolate these results to your other ongoing trials and potential indications? Secondly, if I may, how do you foresee JNJ-1900 will be positioned within the landscape of non-small cell lung cancer treatment paradigm? Thank you.
Albert Agustin: Good morning, good afternoon. This is Albert Agustin on for Jonathan Chang. Congrats on all the progress, and thanks for taking my question. My question also reflects on the CONVERGE data. How do we extrapolate these results to your other ongoing trials and potential indications? Secondly, if I may, how do you foresee JNJ-1900 will be positioned within the landscape of non-small cell lung cancer treatment paradigm? Thank you.
Speaker #7: Good morning. Good afternoon. This is Albert Agostinho on for Dalton Chang. Congrats on all the progress, and thanks for taking my question.
Speaker #7: So my question also reflects on the conference-converged data: how do we extrapolate these results to your other ongoing trials and potential indications?
Speaker #7: And and secondly , if I may , how do you foresee J&J 1900 will be positioned within the landscape of of non-small cell lung , lung cancer treatment paradigm ?
Laurent Levy: Thank you. Well, I think lung stage three cancer, like locally advanced head and neck cancer and other tumor are different because they are coming and they are in different organ. They all share something, is that if you can improve the local control and have a strong rate of response and CR, then you can deeply change the PFS and overall survival. What our product does is improving the absorption of energy, killing more cells. We know when you have local disease, killing more cells may lead to more control. That's the basic thesis that led us to start developing NBTXR3 and going into frontline treatment when patients have a local disease. That's also what J&J is going after. If we think about the two trials in head and neck and this trial in lung cancer.
Laurent Levy: Thank you. Well, I think lung stage three cancer, like locally advanced head and neck cancer and other tumor are different because they are coming and they are in different organ. They all share something, is that if you can improve the local control and have a strong rate of response and CR, then you can deeply change the PFS and overall survival. What our product does is improving the absorption of energy, killing more cells. We know when you have local disease, killing more cells may lead to more control. That's the basic thesis that led us to start developing NBTXR3 and going into frontline treatment when patients have a local disease. That's also what J&J is going after. If we think about the two trials in head and neck and this trial in lung cancer.
Speaker #7: Thank you .
Speaker #3: Thank you. Well, I think lung stage three cancer, like locally advanced head and neck cancer and other tumors, are different because they are coming, and they are in different organs.
Speaker #3: But they all share something. It's that if you can improve the local control and have a strong rate of response and CR, then you can deeply change the PFS and overall survival.
Speaker #3: And what our product does is improving the absorption of energy, killing more cells. And we know when you have a local disease, killing more cells may lead to more control.
Speaker #3: So that's the basic thesis that led us to start developing and going into frontline treatment, when patients have a local disease.
Speaker #3: And that's also what change is going after. If we think about the two trials in head and neck, and this trial in lung cancer for.
Laurent Levy: For us, it does establish the strong power of having local control transforming into benefit for patients. Starting from this point, then we could anticipate or imagine the diffusion of this product across different population that are also getting radiation. It's always crucial to demonstrate that this works when local control plays the key role in the survival and quality of life of patients. That's how we will extrapolate the results of CONVERGE, but also that's what we started to do with the randomized data coming from soft tissue sarcoma, which was a similar situation even though this is maybe way different. That's a good start to any tumor type. If we think about how to extrapolate to other indications, that could be a path.
Laurent Levy: For us, it does establish the strong power of having local control transforming into benefit for patients. Starting from this point, then we could anticipate or imagine the diffusion of this product across different population that are also getting radiation. It's always crucial to demonstrate that this works when local control plays the key role in the survival and quality of life of patients. That's how we will extrapolate the results of CONVERGE, but also that's what we started to do with the randomized data coming from soft tissue sarcoma, which was a similar situation even though this is maybe way different. That's a good start to any tumor type. If we think about how to extrapolate to other indications, that could be a path.
Speaker #3: For us, it does establish the strong power of having local control transforming into benefits for patients, and starting from this point, then we could anticipate our imaging diffusion of this product across different populations that are also getting radiation.
Speaker #3: But it always points to demonstrate that this works when local control plays the key role in the survival and quality of life of patients.
Speaker #3: So that's how we will extrapolate the results of CONVERGE. But also, that's what we started to do with the randomized data coming from soft tissue sarcoma, which was a similar situation.
Speaker #3: Even though this is very, very different. And that's a good start to any tumor type. And if we think about how to extrapolate to other indications, that could be a path.
Laurent Levy: Now for lung cancer, there are many patients receiving radiation. Beyond lung stage three is around 77% of lung cancer patients getting radiation. Not to mention that small cell lung cancer is also another indication where radiation is key. We could imagine, but again, that would be J&J's decision, to spread this product across different lung subpopulation.
Laurent Levy: Now for lung cancer, there are many patients receiving radiation. Beyond lung stage three is around 77% of lung cancer patients getting radiation. Not to mention that small cell lung cancer is also another indication where radiation is key. We could imagine, but again, that would be J&J's decision, to spread this product across different lung subpopulation.
Speaker #3: Now for lung cancer, there are many patients receiving radiation. Beyond lung stage three, around 77% of lung cancer patients are getting radiation.
Speaker #3: And not to mention that small cell lung cancer is also another indication where radiation is key . So we could imagine , but again , that would be a judges decision to spread this product across different lung subpopulations
Albert Agustin: Thank you.
Albert Agustin: Thank you.
Laurent Levy: Thank you.
Laurent Levy: Thank you.
Speaker #7: Thank you .
Operator: Thank you. We will take our next question, and the question comes from the line of Ramakanth Swayampakula from H.C. Wainwright. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question, and the question comes from the line of Ramakanth Swayampakula from H.C. Wainwright. Please go ahead. Your line is open.
Speaker #3: Thank you .
Speaker #1: Thank you. We will take our next question. And the question comes from the line of Swayam Pakula Ramakanth from H.C. Wainwright.
Speaker #1: Please go ahead. Your line is open.
Ramakanth Swayampakula: Thank you. This is RK from H.C. Wainwright. Good afternoon, Laurent, Bart, and Johan. I also have a couple of quick questions on CONVERGE. So, you know, in your mind, do you see J&J, when they're spending time on both NANORAY-312 and CONVERGE, do you see them sourcing equal time for both of these projects? And additionally, do you have any data from your partner regarding abscopal effect in the lung? Because injecting into lung lesions are potentially technically challenging. So how do you and your partners see this being a successful therapeutic modality in the lung?
Ramakanth Swayampakula: Thank you. This is RK from H.C. Wainwright. Good afternoon, Laurent, Bart, and Johan. I also have a couple of quick questions on CONVERGE. So, you know, in your mind, do you see J&J, when they're spending time on both NANORAY-312 and CONVERGE, do you see them sourcing equal time for both of these projects? And additionally, do you have any data from your partner regarding abscopal effect in the lung? Because injecting into lung lesions are potentially technically challenging. So how do you and your partners see this being a successful therapeutic modality in the lung?
Speaker #8: Thank you . This is from . Good afternoon , Lauren , Bart and Johan I also have a couple of quick questions on converge .
Speaker #8: So You know , in in your mind , do you see J . R when they're spending time on both nanoarray 3123 12 and converge .
Speaker #8: Do you see them sourcing equal time for both of these projects? And additionally, do you have any data from your partner regarding abscopal effect in the lung?
Speaker #8: Because injecting into lung lesions or potentially technically challenging . So how how do we how do you how do you and your partner see this being a successful therapeutic modality in the lung ?
Laurent Levy: Okay. Thanks, RK. Well, first of all, about the bandwidth, or the investment in lung versus head and neck. I think a phase 3 is always bigger than the phase 2, and in that case, that's a very big phase 3 versus the CONVERGE trial. So there's much more people working on one than the other, which is normal given the size of things. The attention is equally important from our perspective and what we can observe. And obviously, as I mentioned previously, the lung is a very important trial for J&J and also for us, because if it does work, that's really opening a big market for J&J 1900 or NBTXR3. Let's say that what we observe is they're pushing all fronts to make sure that all this could happen. Now on the Abscopal effect, I think that's a big question.
Laurent Levy: Okay. Thanks, RK. Well, first of all, about the bandwidth, or the investment in lung versus head and neck. I think a phase 3 is always bigger than the phase 2, and in that case, that's a very big phase 3 versus the CONVERGE trial. So there's much more people working on one than the other, which is normal given the size of things. The attention is equally important from our perspective and what we can observe. And obviously, as I mentioned previously, the lung is a very important trial for J&J and also for us, because if it does work, that's really opening a big market for J&J 1900 or NBTXR3. Let's say that what we observe is they're pushing all fronts to make sure that all this could happen. Now on the Abscopal effect, I think that's a big question.
Speaker #3: Okay . Thank thank . Arthur . Well , first of all , about the bandwidth or the investment in lung versus head and neck , I think a phase three is always bigger than the phase two .
Speaker #3: And in that case, that's a very big Phase Three versus the CONVERT trial. So there's much more people working on one than the other, which is normal given the size of things.
Speaker #3: But the attention is equally important from our perspective and what we can observe . And obviously , as I mentioned previously , the lung is a very important trial for JNJ and also for us , because if it does work , that's really opening a big market for Jiang89 and Reds or Nbtxr3 , but let's say that what we observe is they're pushing all fronts to make sure that all this could happen .
Speaker #3: Now in the Abscopal effect , I think that's that's a big question . That's an effect we already observed that in melanoma patients , head and neck patients , some of the lung patients , when they have met up with or without primary tumor , when we do inject one lesion and irradiate that lesion , we see a distinct effect in the non-irradiated non-injected lesion .
Laurent Levy: That's an effect we already observed that in melanoma patients, head and neck patients, some of the lung patients, when they have mets, with or without primary tumor, when we do inject one lesion and irradiate that lesion, we see a distant effect in the non-irradiated, non-injected lesion. That's something we start observing in many different clinical situations that will be very useful to understand and to investigate when we think about metastatic patients. For the vast majority of patients getting radiation, they have no mets. They have a local or locoregional disease. Here, local control is much more important than any potential immune response. If we can provide it through local injection of the particle plus the radiation, that could be a win.
Laurent Levy: That's an effect we already observed that in melanoma patients, head and neck patients, some of the lung patients, when they have mets, with or without primary tumor, when we do inject one lesion and irradiate that lesion, we see a distant effect in the non-irradiated, non-injected lesion. That's something we start observing in many different clinical situations that will be very useful to understand and to investigate when we think about metastatic patients. For the vast majority of patients getting radiation, they have no mets. They have a local or locoregional disease. Here, local control is much more important than any potential immune response. If we can provide it through local injection of the particle plus the radiation, that could be a win.
Speaker #3: So that's something we start observing in many different clinical situations. That would be very useful to understand and to investigate. When we think about metastatic patient.
Speaker #3: But for the vast majority of patients getting radiation, they have no meds. They have a local or locoregional disease. And here, local control is much more important than any potential immune response.
Speaker #3: And if we can provide it through local injection of the particle plus the radiation , that could be a win . And in the case of Locoregional , when some of the lymph nodes could be involved , then we've seen in in different trials now that we are able to inject lymph node on the top of the primary tumor , which could add also an additional immune response .
Laurent Levy: In the case of local regional, when some of the lymph node could be involved, then we've seen in different trials now that we are able to inject lymph node on the top of the primary tumor, which could add also an additional immune response. Aake, if we just step back a minute, I think this Abscopal effect or the possibility to trigger an immune response is really critical for MET, as I mentioned. Also if you think about local regional disease where radiation plays a role, usually the local regional area is irradiated, which is not in favor of having an immune response because the X-ray, as we know and have seen, could kill some of the activity of the immune system.
Laurent Levy: In the case of local regional, when some of the lymph node could be involved, then we've seen in different trials now that we are able to inject lymph node on the top of the primary tumor, which could add also an additional immune response. Aake, if we just step back a minute, I think this Abscopal effect or the possibility to trigger an immune response is really critical for MET, as I mentioned. Also if you think about local regional disease where radiation plays a role, usually the local regional area is irradiated, which is not in favor of having an immune response because the X-ray, as we know and have seen, could kill some of the activity of the immune system.
Speaker #3: But in our case, let's just step back a minute. I think this abscopal effect, or the possibility to trigger an immune response, is really critical for Matt.
Speaker #3: As I mentioned . But also if you think about locoregional disease , where radiation plays a role , usually the Locoregional area is irradiated , which is not in favour of having an immune response because the X-ray , as we know and are seen , could kill some of the activity of the immune system .
Laurent Levy: Here, the local control brought by physical treatment like radiation with the addition of JNJ-1900 is where we should play and where we should try to win.
Laurent Levy: Here, the local control brought by physical treatment like radiation with the addition of JNJ-1900 is where we should play and where we should try to win.
Speaker #3: So here, the local control brought by physical treatment like radiation with the addition of NBTXR3 is where we should play and where we should try to win.
Ramakanth Swayampakula: Thank you for that. One quick question on Curadigm. You did present some preclinical data previously. Now, thinking going forward, you know, since you also have you know, MTAs with multiple parties, are you planning to initiate an IND from the internal pipeline, or do you expect some of these external collaboration partners to file first? How should we think about that program going forward?
Ramakanth Swayampakula: Thank you for that. One quick question on Curadigm. You did present some preclinical data previously. Now, thinking going forward, you know, since you also have you know, MTAs with multiple parties, are you planning to initiate an IND from the internal pipeline, or do you expect some of these external collaboration partners to file first? How should we think about that program going forward?
Speaker #8: Thank you for that . One quick question on Kirodesign you did present some pre-clinical data previously . Now thinking going forward , you know , since you also have Colab , you know , mtas with multiple parties , are you planning to initiate an IND from the internal pipeline or do you expect some of these external collaboration partners to file first ?
Speaker #8: How should we think about that program going forward?
Laurent Levy: We are pushing both because we think building our internal pipeline will have a first proof of concept of this product into human, and that's what the team is working on. Not only by manufacturing the product and starting pre-IND studies, but also designing the first proof of concept we want to bring to life. If we think about it, as soon as we have established the safety and feasibility of this product into human, that's also opening many more combination possibilities with other products that are already into clinical development. That will not only push forward our pipeline, but also will open many other opportunity for collaboration and licensing out.
Laurent Levy: We are pushing both because we think building our internal pipeline will have a first proof of concept of this product into human, and that's what the team is working on. Not only by manufacturing the product and starting pre-IND studies, but also designing the first proof of concept we want to bring to life. If we think about it, as soon as we have established the safety and feasibility of this product into human, that's also opening many more combination possibilities with other products that are already into clinical development. That will not only push forward our pipeline, but also will open many other opportunity for collaboration and licensing out.
Speaker #3: We are pushing both because we think building our internal pipeline will go through, and we will have a first proof of concept of this product in humans.
Speaker #3: And that's what the team is working on, not only by manufacturing the product and starting pre-IND studies, but also designing the first proof of concept.
Speaker #3: We want to bring to life. And if we think about it, as soon as we have established the safety and feasibility of this product into human, that's also opening many more combination possibilities with other products that are already into clinical development.
Speaker #3: So that will not only push forward our pipeline, but also will open many other opportunities for collaboration and licensing out.
Ramakanth Swayampakula: Thank you. Thanks for taking all my questions.
Ramakanth Swayampakula: Thank you. Thanks for taking all my questions.
Laurent Levy: Thanks, Ramakanth Swayampakula.
Laurent Levy: Thanks, Ramakanth Swayampakula.
Speaker #8: Thank you. Thanks for taking all my questions.
Operator: Thank you. We will take our next question. Your question comes from the line of Chiara Montironi from Van Lanschot Kempen. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. Your question comes from the line of Chiara Montironi from Van Lanschot Kempen. Please go ahead. Your line is open.
Speaker #3: Thanks . Okay .
Speaker #1: Thank you. We will take our next question. Your question comes from the line of Kiara Montironi from Van Lanschot Kempen. Please go ahead.
[Analyst] (Van Lanschot Kempen): Hi, this is Sandrine on for Chiara. Thank you for taking our question. So for the JNJ-driven phase 2 trial on lung, do you expect that JNJ will report an interim before the readout in early 2027? If they do, what do you think they will most likely disclose, the ORR or the PFS, tumor volume up from part one?
[Analyst] (Van Lanschot Kempen): Hi, this is Sandrine on for Chiara. Thank you for taking our question. So for the JNJ-driven phase 2 trial on lung, do you expect that JNJ will report an interim before the readout in early 2027? If they do, what do you think they will most likely disclose, the ORR or the PFS, tumor volume up from part one?
Speaker #1: Your line is open .
Speaker #9: Hi , this is Sandrine on for Chiara . Thank you for taking our questions . So for the J&J driven phase two trial on lung , do you expect that J&J will report an interim before the readout in early 2027 ?
Speaker #9: And if they do , what do you think they will most likely disclose the RR or the post ? Your follow up from part one .
Laurent Levy: Thank you for the question. Yes, that's true. There's multiple readout in this trial. Different rank of response depending on timing inside PD-L1, and also potential measurement as exploratory for other more systemic endpoints like PFS and OS. Now we can talk for J&J. What we can say is what have been said previously, which is the readout of the phase 2 beginning of 2027, but in between, who knows.
Laurent Levy: Thank you for the question. Yes, that's true. There's multiple readout in this trial. Different rank of response depending on timing inside PD-L1, and also potential measurement as exploratory for other more systemic endpoints like PFS and OS. Now we can talk for J&J. What we can say is what have been said previously, which is the readout of the phase 2 beginning of 2027, but in between, who knows.
Speaker #3: Thank you for for the question . So yes , that's true . There are multiple readouts in this trial . Different rate of response depending on timing .
Speaker #3: Throughput for the L1, and also potential measurement as exploratory for other, more systemic endpoints like PFS and OS. Now we can talk for JNJ.
Speaker #3: What we can say is what I've been said for weekly , which is the readout of the phase two beginning of 27 . But in between , who knows ?
[Analyst] (Van Lanschot Kempen): Okay. Thank you. On the MD Anderson lung reirradiation trial, you said you expected to read out in 2027. Is there any possibility you can narrow down on the timing?
[Analyst] (Van Lanschot Kempen): Okay. Thank you. On the MD Anderson lung reirradiation trial, you said you expected to read out in 2027. Is there any possibility you can narrow down on the timing?
Speaker #9: Okay, thank you. And on the MD Anderson reirradiation trial, you said you expected to read out in 2027. Is there any possibility you can narrow down the timing?
Laurent Levy: We filed for different abstract. If first one accepted, that should be around December.
Laurent Levy: We filed for different abstract. If first one accepted, that should be around December.
Speaker #3: We filed for different abstracts. If the first one is accepted, that should be around the summer.
[Analyst] (Van Lanschot Kempen): Okay. Thank you so much for taking the question.
[Analyst] (Van Lanschot Kempen): Okay. Thank you so much for taking the question.
Speaker #10: Okay
Laurent Levy: You're welcome. Thank you for the question.
Laurent Levy: You're welcome. Thank you for the question.
Speaker #9: Thank you so much for taking the question .
Speaker #3: You're welcome. Thank you for the question.
Operator: Thank you. We will take our next question, and the question comes from the line of David Dai from UBS. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question, and the question comes from the line of David Dai from UBS. Please go ahead. Your line is open.
Speaker #1: Thank you . We will take our next question . And the question comes from the line of David De from UBS . Please go ahead .
David Dai: Great. Yeah, thanks for taking my questions and, congrats on the progress. A couple of questions from me as well. Just on CONVERGE trial, you know. Just thinking about the JNJ-1900, how do you think this, you know, early post CRT response seen in sarcomas from the part one could translate into durable local control and PFS benefit in part two? And I have a follow-up after that.
David Dai: Great. Yeah, thanks for taking my questions and, congrats on the progress. A couple of questions from me as well. Just on CONVERGE trial, you know. Just thinking about the JNJ-1900, how do you think this, you know, early post CRT response seen in sarcomas from the part one could translate into durable local control and PFS benefit in part two? And I have a follow-up after that.
Speaker #1: Your line is open .
Speaker #11: Oh , great . Yeah . Thanks for taking my questions . And congrats on the progress . So a couple of questions from me as well .
Speaker #11: So, just on Coverage trial, you know, so just thinking about the 1900, how do you think this early post-PCR response we saw from the PA one could translate into durable local control and PFS benefit in Part Two?
Speaker #11: And I have a follow-up after that.
Laurent Levy: Well, I mean, that depends on how durable will be the response. But that's generally what we have observed in other clinical trial with different disease. When you start getting radiation, you usually get the optimal efficacy of radiation few months after the end of the last session. Here, patients are going directly, I mean, rapidly into durvalumab. The good point is that, first of all of them went to durvalumab, which is not the case when you look at the overall population. Now we need to wait the next set of data to conclude on that. If we believe in what we have seen previously in other trial, we should expect a much greater local control. Now we'll see how this potentially impacts the more systemic aspect of things for the patient.
Laurent Levy: Well, I mean, that depends on how durable will be the response. But that's generally what we have observed in other clinical trial with different disease. When you start getting radiation, you usually get the optimal efficacy of radiation few months after the end of the last session. Here, patients are going directly, I mean, rapidly into durvalumab. The good point is that, first of all of them went to durvalumab, which is not the case when you look at the overall population. Now we need to wait the next set of data to conclude on that. If we believe in what we have seen previously in other trial, we should expect a much greater local control. Now we'll see how this potentially impacts the more systemic aspect of things for the patient.
Speaker #3: Well , I mean , that depends on how durable will be the the response . But that's generally what we have observed in other clinical trials with different disease .
Speaker #3: When you start getting radiation, you usually get the optimal efficacy of radiation a few months after the end of the last session.
Speaker #3: Here , patients are going directly . I mean , rapidly into a durvalumab . The good point is that , first of all , all of them went to the Mab , which is not the case when you look at the overall population .
Speaker #3: And now we need to wait for the next set of data to conclude on that. But if we believe what we have seen previously in other trials, we should expect a much greater local control.
Speaker #3: And now we'll see how this could potentially impact the more systemic aspect of things for the patient.
David Dai: Got it. Okay. Thanks, Laurent. Just on the next slide, just on the part one study here, will we expect another follow-up of this data from the part one and also for the part two, which we're expecting to have some data in early 2027. Could you just help us understand a little more around what's the sort of expected data readout? Would it be ORR or should we look at PFS as well?
David Dai: Got it. Okay. Thanks, Laurent. Just on the next slide, just on the part one study here, will we expect another follow-up of this data from the part one and also for the part two, which we're expecting to have some data in early 2027. Could you just help us understand a little more around what's the sort of expected data readout? Would it be ORR or should we look at PFS as well?
Speaker #11: Got it . Okay . Thanks , Lauren . And then just on next , just on the PA one study here . What were you expecting another follow up of this data from the PA one .
Speaker #11: And also for the part two , which we're expecting , you know , to have some data in early 2027 , just help us understand more around what's the expected data readout .
Speaker #11: Would it be, or should we look at PFS as well?
Laurent Levy: I don't know. What we know is that all this that you mentioned are endpoint of the trials, but we don't know what J&J is going to communicate yet.
Laurent Levy: I don't know. What we know is that all this that you mentioned are endpoint of the trials, but we don't know what J&J is going to communicate yet.
Speaker #3: I don't know. What we know is that all this that you mentioned are endpoints of the trials, but we don't know what JNJ is going to do to communicate yet.
David Dai: Thank you so much for taking my questions.
David Dai: Thank you so much for taking my questions.
Laurent Levy: Thank you, David.
Laurent Levy: Thank you, David.
Speaker #11: Thank you so much for taking my questions .
Speaker #3: Thank you David
Operator: Thank you. Your next question comes from the line of Michael Schmidt from Guggenheim. Please go ahead. Your line is open.
Operator: Thank you. Your next question comes from the line of Michael Schmidt from Guggenheim. Please go ahead. Your line is open.
Speaker #1: Thank you. Your next question comes from the line of Michael Schmidt from Guggenheim. Please go ahead, your line is open.
Michael Schmidt: Hi, guys. Thanks for taking my questions. I had a couple more on the CONVERGE data from yesterday. Obviously very interesting. Could you confirm whether part two of that study is enrolling or are still patients being added to part one, so the safety lead-in component of the trial?
Michael Schmidt: Hi, guys. Thanks for taking my questions. I had a couple more on the CONVERGE data from yesterday. Obviously very interesting. Could you confirm whether part two of that study is enrolling or are still patients being added to part one, so the safety lead-in component of the trial?
Speaker #12: Hi , guys . Thanks for taking my questions . I had a couple more on the convert data from yesterday . Obviously . Very interesting .
Speaker #12: Could you confirm whether part two of that study is enrolling, or are there still patients being added to part one of the safety lead-in component of the trial?
Laurent Levy: Yeah. Part 1 has been completed, and the Phase 2 part, randomized part, is enrolling since last year.
Laurent Levy: Yeah. Part 1 has been completed, and the Phase 2 part, randomized part, is enrolling since last year.
Speaker #3: Yeah . One has been completed and the phase two part randomized , part is enrolling since last year .
Michael Schmidt: Okay, that makes sense. Yeah, so just so you did note the sort of next update in early 2027. Is your impression that this is sufficient for your partner to potentially make a phase 3 go decision? Or do you think more follow-up may be needed to look at things like, you know, DFS or maybe even OS to make that move into a large phase 3 trial?
Michael Schmidt: Okay, that makes sense. Yeah, so just so you did note the sort of next update in early 2027. Is your impression that this is sufficient for your partner to potentially make a phase 3 go decision? Or do you think more follow-up may be needed to look at things like, you know, DFS or maybe even OS to make that move into a large phase 3 trial?
Speaker #12: Okay , that makes sense . And then yeah , so just so you did know , the sort of next update in early 2027 is your impression that this is sufficient for your partner to potentially make a phase three decision ?
Speaker #12: Or do you think more follow-up may be needed to look at things like DFS, or maybe even OS, to make that move into a large Phase 3 trial?
Laurent Levy: That's a very good question, Michael. I think overall, first of all, a response in those patient population, if you find a high rate of response, then you should get an impact and a correlation with PFS and OS. I think the number of CR globally also could be a surrogate of that, as specific did show very little rate of CR, less than 1.7% in the post Jova treatment. Globally, patient, if you look at the dynamic of the curve, they're relapsing quite fast in Jova arm and versus radioplus chemo. I think comparing all those data, we can say if you beat that bar, then you move to Phase 3 directly. You don't need PFS. You don't need OS.
Laurent Levy: That's a very good question, Michael. I think overall, first of all, a response in those patient population, if you find a high rate of response, then you should get an impact and a correlation with PFS and OS. I think the number of CR globally also could be a surrogate of that, as specific did show very little rate of CR, less than 1.7% in the post Jova treatment. Globally, patient, if you look at the dynamic of the curve, they're relapsing quite fast in Jova arm and versus radioplus chemo. I think comparing all those data, we can say if you beat that bar, then you move to Phase 3 directly. You don't need PFS. You don't need OS.
Speaker #3: That's a very good , very good question . Michael . I think overall , first of all , I response in those patient population .
Speaker #3: If you find a higher rate of response , then you should get an impact and a correlation with PFS and OS . I think the number of CR globally also could could be a surrogate of that as Pacific Digital very little rate of CR less than 1.7% in the post Jehovah treatment .
Speaker #3: But globally patient . If you look at the dynamic of the curve , there relapsing quite fast in in Jehovah , in Jehovah , ahm and versus radio plus chemo .
Speaker #3: So, I think, comparing all those data, we can say if you beat that bar, then you move to phase three directly.
Laurent Levy: I think that should be a mix of results linked to number of patients getting to J&J, because usually 30% are not. Number of patients getting response, number of patients getting complete response, and then you can start following PFS and OS to see. A combination of all these or just few of them, depending on the magnitude, could be enough. At the end, that's JNJ's decision to look at this and to take the path moving forward.
Laurent Levy: I think that should be a mix of results linked to number of patients getting to J&J, because usually 30% are not. Number of patients getting response, number of patients getting complete response, and then you can start following PFS and OS to see. A combination of all these or just few of them, depending on the magnitude, could be enough. At the end, that's JNJ's decision to look at this and to take the path moving forward.
Speaker #3: You don't need PFS, you don't need OS. I think that should be a mix of results linked to the number of patients getting to the other, because usually 30% are not the number of patients getting response.
Speaker #3: Number of patients getting complete response, and then you can start following PFS and OS to see. But a combination of all these are just a few of them—depending on the magnitude, could be enough.
Speaker #3: But at the end that's that's Zhang's decision to , to look at this and to take the path moving forward .
Michael Schmidt: Okay. Makes sense. Then another one. I know this may be again, difficult to answer, but what is your sense how J&J may prioritize other indications beyond, head and neck and lung? For example, breast cancer is obviously a very big opportunity and prostate as well. To what degree do you think they're incorporating data that's sort of coming out of the IST that have been ongoing?
Michael Schmidt: Okay. Makes sense. Then another one. I know this may be again, difficult to answer, but what is your sense how J&J may prioritize other indications beyond, head and neck and lung? For example, breast cancer is obviously a very big opportunity and prostate as well. To what degree do you think they're incorporating data that's sort of coming out of the IST that have been ongoing?
Speaker #12: Okay . Makes sense . Then another one . I know this may be again , difficult to answer , but what is your sense ?
Speaker #12: How might JJ prioritize other indications beyond head and neck and lung? For example, breast cancer is obviously a very big opportunity, and prostate as well.
Speaker #12: And to what degree do you think they're incorporating data that's sort of coming out of the ISTs that have been ongoing?
Laurent Levy: Well, that's a tricky question we can't answer. What we can say is, you can see the priorities of JNJ in terms of indications like lung, bladder, head and neck, and so on. As you mentioned, breast cancer is not part of those priorities. Also we have all the trials we've been running or are still running with MD Anderson that could serve as a base for expansion. Even though we have a lot of discussion with JNJ's team about optionalities, there's nothing we can say at this moment.
Laurent Levy: Well, that's a tricky question we can't answer. What we can say is, you can see the priorities of JNJ in terms of indications like lung, bladder, head and neck, and so on. As you mentioned, breast cancer is not part of those priorities. Also we have all the trials we've been running or are still running with MD Anderson that could serve as a base for expansion. Even though we have a lot of discussion with JNJ's team about optionalities, there's nothing we can say at this moment.
Speaker #3: Well, that's a tricky question. We can't answer, but what we can say is that you can see the priorities of JNJ in terms of indications like lung, bladder, head and neck, and so on.
Speaker #3: So as you mentioned , breast cancers , not part of those priorities . Also , we have all the trials we've been running are still running with MD Anderson that could serve as a base for expansion .
Speaker #3: But even though we have a lot of discussion with JJ's team about optionality, there's nothing we can say at this moment.
Michael Schmidt: Okay. We'll keep our eyes out for any other updates there. Thank you for the update. Really appreciate it.
Michael Schmidt: Okay. We'll keep our eyes out for any other updates there. Thank you for the update. Really appreciate it.
Speaker #12: So we'll keep our eyes out for any other updates there . Thank you for for the update . Really appreciate it .
Laurent Levy: Thank you, Michael.
Laurent Levy: Thank you, Michael.
Operator: Thank you. Once again, if you wish to ask a question, please press star one one on your telephone. We will take our next question, and the question comes from the line of Shan Hama from Jefferies. Please go ahead. Your line is open.
Operator: Thank you. Once again, if you wish to ask a question, please press star one one on your telephone. We will take our next question, and the question comes from the line of Shan Hama from Jefferies. Please go ahead. Your line is open.
Speaker #3: Thank you . Michael .
Speaker #1: Thank you once again. If you wish to ask a question, please press star one one on your telephone. We will take our next question, and the question comes from the line of Shabnam from Jefferies.
Speaker #1: Please go ahead. Your line is open.
Shan Hama: Hi there. Thank you for taking my question. Just two from me, please. Actually, just on potential indication expansion on JNJ's part. I know there's obviously not much you can comment on their behalf, but the indications that MDA is working on, is there scope for JNJ to actually expand the RP program into those indications, so pancreatic, esophageal, et cetera? That's my first question. Then I can also follow up after.
Shan Hama: Hi there. Thank you for taking my question. Just two from me, please. Actually, just on potential indication expansion on JNJ's part. I know there's obviously not much you can comment on their behalf, but the indications that MDA is working on, is there scope for JNJ to actually expand the RP program into those indications, so pancreatic, esophageal, et cetera? That's my first question. Then I can also follow up after.
Speaker #10: Hi there . Thank you for taking my questions . Just two from me , please Actually , just just on potential indication expansion on JJ's part .
Speaker #10: I know there's obviously not not much you can comment on their behalf , but the indications that MDA is working on , is there scope for J and J to actually expand the RC R3 program into those indications ?
Speaker #10: So a pancreatic , esophageal , etc. ? That's my first question . And then I can also follow up after .
Laurent Levy: I'm sorry. I'm not sure I got. The question was, can they or will they?
Laurent Levy: I'm sorry. I'm not sure I got. The question was, can they or will they?
Speaker #3: I'm sorry, I'm not sure I got the question—was it 'can they' or 'will they?'
Shan Hama: As in can they? Are they able to?
Shan Hama: As in can they? Are they able to?
Laurent Levy: Okay. Yes, of course, they are able to, and obviously all the clinical trial we've been running serve really as a base for discussion with them. They can.
Laurent Levy: Okay. Yes, of course, they are able to, and obviously all the clinical trial we've been running serve really as a base for discussion with them. They can.
Speaker #10: As in, can they, are they able to.
Speaker #3: Okay . Yes , of course they are able to . And obviously all the clinical trials we've been running serve as a base for for discussion with them .
Shan Hama: Okay. That's clear. Just actually on cash burn. Obviously R&D's come down pretty sharply post the transfer to J&J. What's the sort of steady state annual cash burn we should assume through to 2027?
Shan Hama: Okay. That's clear. Just actually on cash burn. Obviously R&D's come down pretty sharply post the transfer to J&J. What's the sort of steady state annual cash burn we should assume through to 2027?
Speaker #3: And they can .
Speaker #10: Okay . That's clear . And then just actually on , on cash burn . So obviously R&D has come down pretty sharply post the transfer to J and J .
Speaker #10: So, what's the sort of steady-state annual cash burn we should assume through to 2027?
Bart Van Rhijn: Thank you for the question. We don't provide specific forward-looking guidance to the individual years, and we refer to the cash runway that is in early 2028. We have a very disciplined approach to how we allocate capital. What you've been used to in the past few years, you should expect to continue to see from us. Maybe one high level comment is that as the three-twelve costs have been transferred to our partner Janssen, we should expect to see development costs on the new platforms that Laurent talked to.
Bart Van Rhijn: Thank you for the question. We don't provide specific forward-looking guidance to the individual years, and we refer to the cash runway that is in early 2028. We have a very disciplined approach to how we allocate capital. What you've been used to in the past few years, you should expect to continue to see from us. Maybe one high level comment is that as the three-twelve costs have been transferred to our partner Janssen, we should expect to see development costs on the new platforms that Laurent talked to.
Speaker #4: Thank you for the question. We don't provide specific forward-looking guidance for the individual years, and we refer to the cash runway that is in early 2028.
Speaker #4: But we have a very disciplined approach to how we allocate capital . So what you've been used to in the past few years , you should expect to continue to see from us maybe one high level command is that as the 312 costs have been transferred to our partner , Jensen , we should expect to see development cost on the new platforms that Laura talked to
Shan Hama: Got it. That's really clear. Thank you so much.
Shan Hama: Got it. That's really clear. Thank you so much.
Laurent Levy: Thank you.
Laurent Levy: Thank you.
Speaker #10: That's really clear. Thank you very much.
Operator: Thank you. Your next question comes from the line of Clément Bassat from Portzamparc, BNP Paribas. Please go ahead. Your line is open.
Operator: Thank you. Your next question comes from the line of Clément Bassat from Portzamparc, BNP Paribas. Please go ahead. Your line is open.
Speaker #3: Thank you .
Speaker #1: Thank you. Your next question comes from the line of Clément Busser from Portzamparc BNP Paribas. Please go ahead, your line is open.
Clément Bassat: Hi, good morning, Laurent, Bart. Thank you for the presentation and for taking my questions. I have two. First, I was wondering how much R&D you spent in oncology in H2, and how much was allocated to Curadigm, just in order to assess the shift. Secondly, regarding the mechanism of Curadigm, my understanding is that with the Nanoprimer, we will reduce the effective dose level, but at the same time, we may also reduce the lethal dose. Could you please provide some insight into the relationship between these two dose if the relationship is linear or not? If this could lead to narrowing the span between these two dose due to the suspension of the liver clearance. Thank you.
Clément Bassat (Portzamparc: Hi, good morning, Laurent, Bart. Thank you for the presentation and for taking my questions. I have two. First, I was wondering how much R&D you spent in oncology in H2, and how much was allocated to Curadigm, just in order to assess the shift. Secondly, regarding the mechanism of Curadigm, my understanding is that with the Nanoprimer, we will reduce the effective dose level, but at the same time, we may also reduce the lethal dose. Could you please provide some insight into the relationship between these two dose if the relationship is linear or not? If this could lead to narrowing the span between these two dose due to the suspension of the liver clearance. Thank you.
Speaker #8: Hi .
Speaker #3: Good morning . Laura . So thank you for the presentation and for taking my questions . I have two first , I was wondering how much already you spent in oncology in H2 and how much was allocated to just in order to , to assess the shift .
Speaker #3: And secondly, regarding the mechanism of Paradeigma, my understanding is that with the primer, we will reduce the effective dose level, but at the same time, we may also reduce the dose.
Speaker #3: So could you please provide some insight into the relationship between these two doses ? If there relationship is linear or not , and if this could lead to narrowing the spread between these two doses due to the suspension of the liver clearance .
Speaker #3: Thank you .
Bart Van Rhijn: Let me try to address the question on the R&D spend and how that is proportioned between our three new platforms. What I can share is that at this time, and this is relating to full year 2025, the spend on the Curadigm has been ramping and should be in the EUR low single-digit millions. Again, as we start to pivot and have pivoted meanwhile to these new platforms, that spend will obviously increase. But for the past year, it was a smaller amount compared to the total R&D spend.
Bart Van Rhijn: Let me try to address the question on the R&D spend and how that is proportioned between our three new platforms. What I can share is that at this time, and this is relating to full year 2025, the spend on the Curadigm has been ramping and should be in the EUR low single-digit millions. Again, as we start to pivot and have pivoted meanwhile to these new platforms, that spend will obviously increase. But for the past year, it was a smaller amount compared to the total R&D spend.
Speaker #4: Let me let me try to address the question on the the R&D spend and how that is . Apportioned between R3 and New platforms .
Speaker #4: What I can share is that at this time , and this is relating to full year 2025 , the spend on QR nine has been ramping and should be in the low single digit millions again , as we start to pivot and have pivoted .
Speaker #4: Meanwhile, with these new platforms, that spend will obviously increase. But for the past year, it was a smaller amount compared to the total R&D spend.
Clément Bassat: All right. Okay.
Clément Bassat (Portzamparc: All right. Okay.
Laurent Levy: Hi, Clément. To your second question about Curadigm, I think the answer is yes, there is a correlation, but will depend also on the need of the product. Let me try to get to that. What the Nanoprimer does is by occupying transampline in the liver, it will allow a second product to circulate more freely. If this product had a strong accumulation in liver, but not much toxicity, what you're going to play on is the ability for the second product to circulate more freely and to reach other targets that it would not be able to reach normally. But if this product had a high liver toxicity, it would prevent it to be used at the right dose, then you will play more on the liver toxicity by preventing the accumulation while allowing some circulation of a therapeutic dose.
Laurent Levy: Hi, Clément. To your second question about Curadigm, I think the answer is yes, there is a correlation, but will depend also on the need of the product. Let me try to get to that. What the Nanoprimer does is by occupying transampline in the liver, it will allow a second product to circulate more freely. If this product had a strong accumulation in liver, but not much toxicity, what you're going to play on is the ability for the second product to circulate more freely and to reach other targets that it would not be able to reach normally. But if this product had a high liver toxicity, it would prevent it to be used at the right dose, then you will play more on the liver toxicity by preventing the accumulation while allowing some circulation of a therapeutic dose.
Speaker #3: All right .
Speaker #13: Hi, Tim. So, to your second question about Shadi M., I think the answer is yes. There is a correlation, but it will also depend on the need for the product.
Speaker #13: Let me try to get to that . So what the nano primer does is by occupying Transcendently the liver , it will allow a second product to circulate more freely .
Speaker #13: So if this product had a strong accumulation in the liver, but not much toxicity, what you're going to play on is the ability for the second product to circulate more freely and to reach other targets that it would not be able to reach normally.
Speaker #13: But if this product has a high liver toxicity, which prevents him from being used at the right dose, then you will play more on the liver toxicity by preventing the accumulation.
Speaker #13: While allowing some circulation of the therapeutic dose. But there is always a correlation between the dose of the nano primer and the quantity that you will avoid being captured in the liver, and the quantity that will be allowed to circulate.
Laurent Levy: There's always a correlation between the dose of the Nanoprimer and the quantity that you will avoid to be captured in the liver and the quantity that will be allowed to circulate. There is a link to that. Different products will request different outcome, and that's where we're gonna play A or B, meaning more efficacy or less safety issue. In some cases, we can play on both.
Laurent Levy: There's always a correlation between the dose of the Nanoprimer and the quantity that you will avoid to be captured in the liver and the quantity that will be allowed to circulate. There is a link to that. Different products will request different outcome, and that's where we're gonna play A or B, meaning more efficacy or less safety issue. In some cases, we can play on both.
Speaker #13: And there is a link to that. But different products will request different outcomes. And that's where we're going to play A or B, meaning more efficacy or less safety issue.
Speaker #13: And in some cases, we can play on both.
Clément Bassat: All right. Thank you.
Clément Bassat (Portzamparc: All right. Thank you.
Speaker #3: All right. Thank you.
Laurent Levy: Thank you, Clément.
Laurent Levy: Thank you, Clément.
Operator: Thank you. This concludes today's question and answer session. I'll now hand back for closing remarks.
Operator: Thank you. This concludes today's question and answer session. I'll now hand back for closing remarks.
Speaker #13: Thank you
Speaker #1: Thank you. This concludes today's question-and-answer session. I'll now hand back for closing remarks.
Laurent Levy: Everyone, thank you very much. It was a pleasure, as usual, to talk to all of you. I think that you are numerous today, attending the call. It's a very good thing, and I hope to see you all shortly for more news about Nanobiotix. Thank you very much. I wish you a great day. Thank you.
Laurent Levy: Everyone, thank you very much. It was a pleasure, as usual, to talk to all of you. I think that you are numerous today, attending the call. It's a very good thing, and I hope to see you all shortly for more news about Nanobiotix. Thank you very much. I wish you a great day. Thank you.
Speaker #13: Everyone thank you very much . It was a pleasure , as usual , to talk to all of you . And I've seen that you are numerous today assisting to the call .
Speaker #13: It's a very good thing, and I hope to see you all in a short while. For more news about Nanobiotix, thank you very much.
Bart Van Rhijn: Thank you all.
Bart Van Rhijn: Thank you all.
Speaker #13: I wish you a great day. Thank you.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker #4: Thank you all .