Nanobiotix S.A.

day and thank you for standing by. Welcome to the Nanobiotics Full Year 2025 Financial Results Conference Core. 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 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 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 U.S. Please go ahead.

Thank you, Heidi. Good afternoon and good morning. And welcome to the Nanobiotics 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 Ryn, 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 four 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. 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 U.S. 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.

Thank you, Joanne, and thank you, everyone. Good morning, good afternoon. Really happy to be here with you today to share our 2025 here. and to give you a bit of perspective of what's going to happen in the next, well, 18 months. 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 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 nanobiotics. While doing so, we've been also pivoting the company towards 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 GMJ. So all together, we've had a rich year and we're pleased to share that with you. 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 a few things about the philosophy with which we are developing things at Nanobiotics. So as you can see here, we mentioned delivering first-in-class therapeutically, but I think Definitely, we're doing more than this. We're creating new class of drugs. That's what we have done for the radio enhancer, for the nanoprimer, and also for the last platform, OQT. And that's really our philosophy. We don't want to do what other biotechs are doing, not because it's bad, because we think there are enough people working on the same target with the same technology. 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. Our strategy is simple and stays in line with what we told you last year. First of all, it's to continue to push and help GMJ to address one of the potentially largest untapped markets in oncology. And that's through our first product, RadioAnswer, that has been licensed to Johnson & Johnson. And beyond this product, we're really pushing hard on new platforms, starting with the CuraDyn platform. which we think is going to disrupt part of how we think about drug development. And we have been starting making good progress in that regard this year. Obviously, we will come back to that in more detail. But let's focus first on NBTSR3 or J&J 1900. What do we mean by addressing one of the largest untapped markets in oncology? Well, I think for that, we still need to look at patients. 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 are diagnosed. 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. 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. And that's exactly what we are trying to achieve with NBT-XR3. And for that, we're working with radiation therapy, which is one of the largest treatments used in oncology, as more than 60% of all cancer patients are getting radiation. And we have a product. that we licensed to GMJ that fit this existing market with almost no competition. And as you can see on this slide, we have a very large pipeline linked to this product that have been developing across many tumor. 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. 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 next steps. This year, 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, 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. All this data I've been showing not only that you could use safely NBTSR3 in different indications, but also start to show some potential good of efficacy for those different indications. And altogether, some consistency in the way you administer a product, but more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefits to patients. But let's focus on the two key developments. As you know, we've been transferring to Johnson & Johnson last year the ongoing phase three in head and neck cancer. That's a very important trial as a phase three and could lead, if positive, to first approval and first market activity around NBT-XR3. This trial is progressing well. J&J now has the full operation on this and also the financial aspect of this trial AfricanCare by J&J, 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, 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 patients frontline that have a locally advanced tumor and that receive radiation and that cannot go to surgery. So technically, if you exclude the two patients that have metastasis at diagnosis, with those two trials, you could capture the vast majority of NMN cancer patients, first-line treatment with the ISM-MED medical trial. So that's a very important pathway and could, if positive, establish NB-TXR3 as a key player in all 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 Jiang Xia is running. The name of this trial is CONVERT. It's a randomized phase two trial in unresectable stage three 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. And it's also, as you know, a gigantic market, if not the biggest market with breast cancer. So here, starting with this trial, assuming that the data are positive, what we feel at Nanobiotics is that could be a trigger for Johnson & Johnson to start expanding the development. But if we just speak to lung cancer, that's already a gigantic market per se. Here we're talking about stage 3, but it could expand into some other indication in lung cancer. And maybe as we did not have the occasion to talk about the data that had been generated, the first part of this data, let's have a small focus on that. 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 to chemo, followed by consolidations with geobalance. 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 from client treatment. which could be at some point an extension of the use of this product, assuming that this trial reads positive. So what's the design of the trial? There's two parties. First, a safety leading 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 DERVA, versus the same plus the product with two different dose. And this is randomized one-to-one-to-one. Total should have 120 patients. And Johnson & Johnson established that they should expect the readout of the randomized path beginning of 2027. The data that have been presented this week are about the safety leading. So 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. So we've been first showing a good safety profile with no serious adverse events linked to the treatment or the procedure, and the feasibility of injection in every patient. Then what has been observed is a good first rate of response that we could see, as we've seen 5 out of 7 patients responding, and equally importantly, we get 100% disease control. meaning that all those patients went to durovalumab, which is not the case if you look at the details of Pacific trials. Many patients have been excluded post-radiation chemo for different reasons, including progression post-radiation chemo, which we did not observe so far in this clinical trial. But altogether, what we can say is a first readout encouraging, and we can wait to see the next steps of this or the final data that should come as we mentioned beginning of 2027. So we can say we've been progressing a lot with this collaboration. Also now that we have transferred the phase three to J&J, They're running most of the operation. We're still running and finishing the 1,100 trials that have completed in terms of recruitment. Now there is some follow-up of patients, and we will continue to deliver some data in that regard. 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 the MD Anderson Cancer Center. But maybe let's take time to talk a little about our new platform, CuraLac. Here, we're still talking about nanophysics, we're still talking about nanoparticles, but with a different perspective, with different particles, with different potential benefits to the patient. Just as a reminder, for those that are new on the call, as I see many, Curadive 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, 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 them IV, the liver will play a role of filter and will capture a big part of them, 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. So 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 lever while delivering at the right place, while delivering the payload and get the good transaction, for example. So you're building a lot of compromise in one object. With the PureLAMP technology, we decided to build what we call a nanoprimer, a second object. This nanoprimer is injected prior to the second product, and this nanoprimer has been specifically designed to transparently getting into the liver and get it occupied for a certain amount of time. So 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 from the body. So 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 a combination of all these. So there are many, many opportunities and many, many applications we could do with this technology. And now a big part of the theme is focused on the development of it. What we've been doing lately is really continuing pushing, meaning filing for four new patents 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. And more importantly, we are moving forward toward the IND and we started the CMC activity with the start of the GMP manufacturing and also the preclinical studies are going to file for an IND. And while doing that, at the internal program at Nano, we've been expanding a lot our external reach-outs. We have now more than 20 NTS 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. And we've done that with many different technologies for different therapeutic areas like oncology, rare disease, CNS disorder. So it's moving quite well. And then we expect an up-to-date future to start transforming some of those NTAs into deals. But 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 our piling up deals with different partners, pharma and biotech. 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 these products to many partners and to our internal pipeline. So things are moving well, and we expect to get a bit more data 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 SDF 120, and that's an index that covers the 120 largest French listed companies by market and cap liquidity. So it does give us a bit more institutional visibility and we've seen through that some of the new investors coming on the top of specialized biotech investors that have entered Allstock last year. And I'm going to take this to give the mic to Bart to talk about the financial part of this presentation.

Thank you, Roland. 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. This progress was supported by two strategic initiatives that meaningfully reshaped our capital requirements and hence 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 3 Nano-Ray 312 study. 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. 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 run way into early 2028, excluding potential milestone inflows. Taken 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. We selected Healthcare Royalty Partners following a comprehensive evaluation or 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 J&J 1900 and our broader strategic objectives. Critically, this royalty structure ensures that our partners' 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 a company beyond anticipated value 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 J&J 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 euro compared to negative €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 Jensen following the transfer of the sponsorship of the NNOA 312 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. This amendment, as Laurent alluded to earlier, eliminated the vast majority of the company's development cost obligations related to the NRA 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 manufacturing expenses related to the development of J&J 1900 and preclinical pipeline activities, a total 23.1 million euro for a 12-month period ended December 31, 2025, which compares to 14.5 million euro for the 12 months ended December 31, 2024. As previously discussed, The significant year-over-year decrease of approximately 43% was primarily driven by the removal of development costs associated with the NR-8312 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 preclinical programs, while maintaining investment in key manufacturing and pipeline activities, supporting the long-term advancement of our old platforms that Romain just spoke to. Selling general and administrative expense for the 12-month period ended December 31, 2025, were flat to significantly, sorry, to slightly down year over year at 20.4 million euro, compared to 20.5 million euro. reflecting continued expense control. Net loss attributable to shareholders was €25 million, or €0.50 per share, for the 12-month period ended December 31, 2025, reflecting a year-over-year decrease of 65%. 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 the net loss of €68.1 million, or €1.44 per share recorded for the same period last year. As we turn to cash and cash equivalents, as of December 31, 2025, that amounted to €52.8 million, compared to €49.7 million as of December 31, 2024. Based on the current operating plan and financial projections, Nanobiotics anticipates that the cash-in-cash equivalents of €52.8 million as of December 31, 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 value 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. And now I would like to turn the call back to Laurent.

Thank you, Bob. 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 going to transform that into business. On the top of that, the NBGXR3 or GMJ1900 development is still key in our development, as should be the critical next step for value creation, as we expect to get the results of the Phase 3 in first half of 2017 and the results of the Phase 2 in Lancaster in early 2027. Besides this, this year we're going to deliver four different results of clinical trials, which three of them have been completed, so you'll be able to see the final data for this. The key takeaway for today, if we think about 2025 and what's coming, is the changes partnership and the development of NBT-XR3 is moving in the right direction with amplification of the development through multiple trials. We've continued to show that potential use of NBTSR3 across different indications, which reinforces the potential value of this product. And as mentioned, we've continued the paradigm development, a new class of products that we intend to bring to life. As Bob just mentioned, we're getting in a good financial position as our cash feasibility is going into 2028, beyond key milestones in heaven, lake, and land, and potential user milestones. And as you have just seen, we have multiple near-term data readouts that could continue to show, assuming it's positive, that NBGXR3 could really improve the lives of millions of patients. Thank you very much for your attention, and now we're going to open the call for questions.

Thank you. As a reminder, to ask a question, you will need to press star 1, 1 on your telephone, and make your name to be announced. To withdraw your question, please press star 1, 1 again. We will take our first question. Your first question comes from the line of Tara Bancroft from TD Cohen. Please go ahead. Your line is open.

Hi. Good morning or good afternoon for you guys. So my question is about, you know, the long 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 asked because Pacific seems to be the best comp here, where ORR was actually around 30%, so just curious to hear your thoughts on that. And 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 – potentially improving even further in part two. Thanks so much.

Thank you, Sarah. Well, I think there are a few paper or historical control because Luke has comparator for that. As a context, we're using the Pacific regimen in this trial in patients getting radiation plus chemo, and if they do not progress, then they go to Jovalimab. If you look at the Pacific paper, they start with 983 patients that receive radiation plus chemo, and out of that, only 70% will be randomized, two patients in the direction of DERVA, one with placebo. So there is, in the evaluation of the response rate in the Pacific paper, something telling 40, 48% of response, but that excludes the 30% patients that have been not treated after that with duvalumab. So that's the response rate different after radiochemo. And if you look at the response rate post-duvalumab, then it's going down, but it's going down slower than the placebo arm. And here you find a 27% response that you probably mentioned. But again, this 27% response is excluding the patients that have been frontline excluded from the trial before randomization. So 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. But 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 Jehovah, 30%. and then the rate is going down over time. So I think if R3 can provide a real local control, then we should see something different happening versus what you can observe with your value map. But 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.

Great. Thanks.

Thank you, Terence.

Thank you. We will take our next question. Your next question comes from the line of Clemence Teers from . Please go ahead. Your line is open.

Thank you, and thank you for the presentation. Just to come back to the study, full data will be in early 2027. Is there any chance you or could file based on the study, or do you have to run a phase three afterwards? That's the first question.

Hi Clemence, thank you for the question. Well, first of all, we can talk for our partner. J&J now is running the convert trial and has the license on the product, 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. But if the data are excellent, everything is open. But again, that will be a GMJ's decision to move that direction or to do a proper phase three after that. Okay, thank you. But for the best.

Yeah, that was worth a shot. And the second question, saying 2026, we'll have all those additional data sets from your IELTS study and GMJ studies. other the last ones in the sense that will you be after that at the stage where you again gently decide whether you move forward with it or not?

I think some of those trials have been completed like the melanoma cancer trial, the lung reradiation and the last one esophageal cancer. to know that we are now looking with MD Anderson at opening some potential new trials to explore new avenues. But 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. And now it's within the end of the engine, but also discussing with us about potential next steps. But nothing new. that we can say at this stage. I have one mention to do is to maybe take a particular look at the MD Anderson cancer trial about lung re-radiation. 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. So we will pay particular attention to this trial, but also we'll bring that to your attention.

Okay. Thank you very much.

Thank you, Clemence.

Thank you. We will take our next question. Your next question comes from the line of Jonathan Chang from Lear Inc. Partners. Please go ahead. Your line is open.

Good morning. Good afternoon. This is Albert Agostinos on for Jonathan Chang. Congrats on all the progress, and thanks for taking my question. So my question also reflects on the Converse data. how do we extrapolate these results to your other ongoing trials and potential indications? And secondly, if I may, how do you foresee J&J 1900 will be positioned within the landscape of non-small cell lung cancer treatment paradigm? Thank you. Thank you.

Well, I think long-stage pre-cancer, like locally advanced head and neck cancer and other tumor are different because they are coming and they are in different organs, but 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 PSS and overall survival. 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. So that's the basic thesis that led us to start developing NBTXR3 and going into frontline treatment when patients have a local disease. And that's also what Change Day is going after if we think about the two trials in head and neck and this trial in lung cancer. For us, it does establish the strong power of having local control transforming into benefit for patients. And starting from this point, then we could anticipate or imagine the diffusion of this product across different population that are also getting radiation. But it's always pure to demonstrate that this works when local control plays the key role in the survival and quality of life of patients. So that's how we will extrapolate the results of CONVIRT, 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 really different. And that's a good start to any tumor type. And if we think about how extrapolate to other indications, that could be a pass. Now, for lung cancer, there are many patients receiving radiation beyond lung stage 3. It's around 77% of lung cancer patients getting radiation. 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 change in decision, to spread this product across different land subpopulation.

Thank you. Thank you.

Thank you. We will take our next question, and the question comes from the line of Swayam Pakula Ramakant from HC Wainwright. Please go ahead. Your line is open.

Thank you. This is RK from . Good afternoon. 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 abdiscopal effect in the lung? Because injecting into lung lesions are potentially technically challenging. So how do you and your partner see this being a successful therapeutic modality in the lung.

Okay. Thanks, Arthur. Well, first of all, about the bandwidth or the investment in lung versus head and neck, I think the phase three is always bigger than the phase two. 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, but the attention, is equally important from our perspective and what we can observe. And obviously, as I mentioned previously, the loan 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 NBG XR3. But let's say that what we observe is they're pushing all front to make sure that all this could happen. Now, the abscopal effect, I think 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 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. So 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. But for the vast majority of patients getting radiation, they have no net. They have a local or local regional disease. And here, local control is much more important than any potential immune response. And if we can provide a true local injection of the particle plus the radiation, that could be a win. And in the case of local regional, when some of the lymph nodes could be involved, then we've seen in different trials now that we are able to inject lymph nodes on the top of the primary tumor, which could add also an additional immune response. But Arki, 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. But 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. So here the local control brought by physical treatment like radiation with the addition of GEN-GEN1900 is where we should play and where we should try to win.

Thank you for that. One quick question on curidine. 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?

We're pushing both because we think Building our internal pipeline will go to 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. 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. So that will not only push forward our pipeline, but also will open many other opportunities for collaboration and licensing out.

Thank you. Thanks for taking all my questions. Thanks, Arte.

Thank you. We will take our next question. Your question comes from the line of Chiara Monteroni from Van Lanshot, Kempen. Please go ahead. Your line is open.

Hi, this is Sandrine, also Chiara. Thank you for taking our question. So for the J&J driven phase 2 trial and launch, do you expect that J&J will report an infant before the readout in early 2027? And if they do, what do you think they will most likely disclose, the ORR or to close your volume up from part one.

Thank you for the question. So, yes, that's true. There are multiple readouts in this trial, different rank of response, depending on timing, and also potential measurement as exploratory for other more systemic endpoints like PFS and OS. Now we can talk for 4GMJ, and what we can say is which is the readout of the phase two beginning of 27. But in between, who knows?

Okay, thank you. And on the MD Anderson lung re-irridation trial, you said you expected to read out in 2027. Is there any possibility you can narrow down on the timing?

We filed for different abstract. If first one accepted, that should be around December.

Okay. Thank you so much for taking the question.

You're welcome. Thank you for the question.

Thank you. We will take our next question, and the question comes from the line of David Day from UBS. Please go ahead. Your line is open.

Great. Yeah, thanks for taking my questions, and congrats on the progress. So, a couple of questions for me as well. So, just on the CONVERGE trial, you know, so just thinking about the Johnson 1900, how do you think this, you know, early post-CCRT response seen or saw from the PAR 1 could translate into durable load control and PFS benefit in PAR 2? And I have a follow-up after that.

Well, I mean, that depends on how durable will be the response. But generally, what we have observed in other clinical trials with different disease, when you start getting radiation, you usually get the optimal efficacy of radiation a few months after the end of the last session. Here, patients are going directly, I mean, rapidly into durovalumab. The good point is that, first of all, all of them went to the Ovarimab, which is not the case when you look at the overall population. And now we need to wait for the next set of data to conclude on that. But if we believe of what we have seen previously in other trials, we should expect a much greater local control. And now we'll see how this potentially impacts a more systemic aspect of things for the patient.

Thanks, Laurent. And then just on the next one, just on the PAR1 study here, were we expecting another follow-up of this data from the PAR1 and also for the PAR2, which we're expecting to have some data in early 2007, could you just help us understand a little more around what's the expected data readout? Would it be OR or should we look at them PFS as well?

I don't know. What we know is that all these that you mentioned are endpoints of the trials, but we don't know what change is going to communicate yet.

Thank you so much for taking my questions.

Thank you, David.

Thank you.

Your next question comes from the line of Michael Schmidt from Guggenheim. Please go ahead. Your line is open.

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 of the safety lead-in component of the trial?

Yeah, part one has been completed. And the phase two part, randomized part, is enrolling since last year.

Okay, that makes sense. And then, 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 three 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 III trial?

That's a very good question, Michael. I think overall, first of all, response in those patient population, if you find a high rate of response, then you should get an impact and a correlation with DFS and WES. I think the number of CR globally also could be a surrogate of that, as Pacific dictates a very little rate of CR, less than 1.7% in the post-Jova treatment. But globally, patients, if you look at the dynamics of the curve, they're relapsing quite fast in Jova arms. And versus radio plus chemo. So I think comparing all those data, we can say if you beat that bar, then you move to phase three directly. You don't need PFS. You don't need OS. I think that should be a mix of results linked to number of patients getting to do over 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. But a combination of all these or just a few of them, depending on the magnitude, could be enough. But at the end, that changes decision to look at this and to take the path moving forward.

Okay. Makes sense. And then another one, I know this may be, again, difficult to answer. What if you 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. And to what degree do you think they're incorporating data that's sort of coming out of the ISTs that have been ongoing?

Well, that's a tricky question we can't answer. What we can say is You can see the priorities of J&J in terms of indications like lung, bladder, head and neck, and so on. So, 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. But even though we have a lot of discussion with GMJ's team about optionality, there's nothing we can say at this moment.

Okay, so we'll keep our eyes out for any other updates. Thank you for the update. Really appreciate it. Thank you, Michael.

Thank you. Once again, if you wish to ask a question, please press star 1-1 on your telephone. We will take our next question, and the question comes from the line of Shanhammer from Jefferies. Please go ahead. Your line is open. Hi there.

Thanks for taking my question. Just two from me, please. Actually, just on potential indication expansion on J&J's part, I know there's obviously not much you can comment on their behalf. But the indications that NDA is working on, is there scope for J&J to actually expand the R3 program into those indications, so pancreatic, esophageal, et cetera? That's my first question, and then I can ask the follow-up after.

I'm sorry, I'm not sure I got you. The question was, can they or will they?

As in can they? Are they able to?

Yes, of course, they are able to. And obviously, all the clinical trials we've been running, surgery as a base for discussion with them. And they can.

Okay, that's clear. And then just actually on cash burns. So obviously, R&D has come down pretty sharply post the transfer to J&J. So, what's the sort of steady state annual cash burn we should assume through to 2027?

Thank you for the question. We don't provide specific forward-looking guidance to the individual years, and we refer to the cash runaway that is in early 2028, 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 comment is that as the 312 costs have been transferred to our partner Jensen, we should expect to see development costs on the new platforms that we'll want to talk to.

Got it. That's really clear. Thank you so much.

Thank you.

Thank you. Your next question comes from the line of Clement Bassa from Port Zon Park BMP Paribas. Please go ahead. Your line is open.

Good morning, Laurent, Bart. 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 Curadigm just in order to assess the shift. And 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. So, could you please provide some insight into the relationship between these two doses, if their relationship is linear or not, and if this could lead to narrowing the span between these two doses due to the suspension of the liver clearance? Thank you.

Let me try to address the question on the R&D spent and how that is proportioned R3 and new platforms. What I can share is that at this time, and this is relating to full year 2025, the spend on the QR9 has been ramping and should be in the 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.

All right. So to your second question about curadine, 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. So what the nanoprimer does is by occupying transantly the liver, it will allow a second product to circulate more freely. So 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 target that will not be able to reach normally. But if this product has a high liver toxicity which prevents him 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. But 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. And there is a link to that. But different products, will request different outcome, and that's where we're going to play A or B, meaning more efficacy or less safety issue. In some cases, we can play on both. All right.

Thank you.

Thank you very much.

Thank you. This concludes today's question and answer session. I'll now hand back for closing remarks.

Everyone, thank you very much. It was a pleasure, as usual, to talk to all of you. And I think that you are numerous today, assisting to the call. It's a very good thing. And I hope to see you all in a short for more news about nanobiotics. Thank you very much. I wish you a great day. Thank you.

Thank you all. This concludes today's conference call. Thank you for participating. You may now disconnect.