Nanobiotix - ADR Aktie

Good day, and thank you for standing by. Welcome to the Nanobiotix Full Year 2025 Financial Results Conference Call. [Operator Instructions] 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 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. 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 year and to give you a bit of perspective of what's going to happen in the next 12 to 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 highlights 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 in 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.

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 is beyond the timing of some of the expected milestones that should come from the collaboration with J&J. So altogether, we've had a rich year, and we are pleased to share that with you. And now we're going to go in some more details to give you a bit of insight. Before getting there, we would just like to remind a few things about the philosophy with which we are developing things at Nanobiotix.

So as you can see here, we mentioned delivering first-in-class directly. But I think definitely, we are doing more than this. 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 OOcuity. And 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 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 stay in line 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 market in oncology. And that's through our first product, radioenhancer that has been licensed to Johnson & Johnson. And 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. 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 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.

And when patients are diagnosed with cancer, the vast majority of them have a local disease. It's more than 70% of patients having local disease at diagnosis. 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 NBTXR3. 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 J&J that fits 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 tumors. 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 point 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 recurrent metastatic patients, also pancreatic cancer, esophageal cancer, melanoma cancer and lung cancer. All those data have been showing not only that you could use safely NBTXR3 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 the product, but more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefit to patients. Let's focus on the 2 key developments. As you know, we've been transferring to Johnson & Johnson last year, the ongoing Phase III in head and neck cancer. That's a very important trial as a Phase III and could lead, if positive, to first approval and first market activity around NBTXR3.

This trial is progressing well. J&J now has the full operation on this and also the financial aspects of this trial are taken care 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 III, J&J has also started a Phase Ib in another population of head and neck, meaning patients getting radiation plus cisplatin. If you think about head and neck cancer, with those 2 trials, you're technically capturing all the patients frontline that have a locally advanced tumor and that received radiation and that cannot go to surgery. So technically, if you -- if you exclude, sorry, the few patients that have metastasis at diagnosis, with those 2 trials, you could capture the vast majority of head and neck cancer patients, first-line treatment with the highest unmet medical need.

So that's a very important pathway and could, if positive, establish NBTXR3 as a key player in 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 II trial in unresectable Stage III 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 Nanobiotix is that could be a trigger for Johnson & Johnson to start expanding the development. But if we just stick to lung cancer, that's already a gigantic market per se. Here, we're talking about Stage III, but could expand into some other indication in lung cancer. 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. As I mentioned, we are talking here about patients that have a locally advanced unresectable Stage III lung cancer and the treatment of reference is radiation to chemo followed by consolidation with durvalumab. And 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 expansion of the use of this product, assuming that this trial read positive.

So what's the design of the trial? There's 2 parts in it. First, a safety leading with very few patients and then what we call a proof of concept with the randomized part of the trial where we compare the standard of care chemo radiation with durvalumab versus the same plus the product with 2 different dose. And this is randomized 1:1:1. Total should have 120 patients. And 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 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 observe here.

So we've been first showing a good safety profile with no serious adverse events linked to the treatment of 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 will go or went to durvalumab, which is not the case if you look at the details of PACIFIC trial. Many patients have been excluded post radiation and chemo for different reasons, including progression post radiation and chemo, which we did not observe so far in this clinical trial.

But altogether, what we can say it's 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. So we can say we've been progressing a lot with this collaboration. Also now that we have transferred the Phase III to J&J, they are running most of the operation. We're still running and finishing the 1,100 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. 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.

But 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 do 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 therapy 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 liver while delivering at the right place while delivering the payload and get the good transection, for example, so you're building a lot of compromise in one object. With the Curadigm 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 transiently getting into the liver and get it occupied for a certain amount of time. So why 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 organ from the body.

So what you could do with this approach is improving pharmacokinetic of a product, allowing when it's not possible to escape the liver, reducing liver toxicity or combination of all this. 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. What we've been doing lately is really continuing pushing, meaning filing for 4 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 towards the IND, and we started the CMC activity with the start of the GMP manufacturing and also preclinical studies allowing to file for an IND.

And while doing that, that the internal program at Nano, we've been expanding 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 pharmacokinetic 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 in a not-too-distant future to start transforming some of those MTAs into deals. But globally, the way we see the value of this platform and the 3 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 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 this product to many partners and to our internal pipeline. So 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 120 largest French listed company 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 our stock 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, Laurent. 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 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 III NANORAY-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 nondilutive 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. 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 nondilutive capital into the company. 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 a high degree of alignment around the long-term potential of JNJ-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 the 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 JNJ-1900 and supports our continued progress towards long-term sustainability and profitability.

Moving over to our full year financial highlights. For the full year 2025, we recognized positive revenue of EUR 32.6 million compared to negative EUR 7.2 million for the year ended 2024. As a reminder, the negative revenue recorded in 2024 was primarily driven by a onetime 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 onetime accounting impact of EUR 21.8 million associated with the amendment 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 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 nonrecurring.

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 preclinical pipeline activities and totaled EUR 23.1 million for the 12-month period ended December 31, 2025, which compares to EUR 40.5 million 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 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 preclinical programs, while maintaining investment in key manufacturing and pipeline activities, supporting the long-term advancement of our all platforms that Laurent 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 EUR 20.4 million compared to EUR 20.5 million, reflecting continued expense control.

Net loss attributable to shareholders was EUR 24 million or EUR 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 noncash 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 reported for the same period last year. As we turn to cash and cash equivalents, as of December 31, 2025, that amounted to EUR 52.8 million compared to EUR 49.7 million as of December 31, 2024.

Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of EUR 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 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. And now I would like to turn the call back to Laurent.

Thank you, Bart. 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 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 results of the Phase III in first half of '27 and the results of the Phase II in lung cancer in early 2027. Besides this, this year, we're going to deliver 4 different results of clinical trials, which 3 of them have been completed, so you will 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 J&J 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 reinforces the potential value of this product. And as mentioned, we've continued the Curadigm development, a new class of drug that we intend to bring to life.

As Bart just mentioned, we're getting in a good financial position as our cash visibility is going into 2028 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 life of millions of patients. Thank you very much for your attention, and now we're going to open the call for questions.

[Operator Instructions] Your first question comes from the line of Tara Bancroft from TD Cowen.

So my question is about the lung data that you guys showed from CONVERGE yesterday that were really interesting even it's only in the first 7 patients. So 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%. 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 2?

Thank you, Tara. Well, I think there are a few paper or historical control we could look at comparator for that. As a context, we are using the PACIFIC regimen in this trial and 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 received radiation plus chemo. And out of that, only 70% will be randomized, 2 patients in the direction of durvalumab, 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 durvalumab.

So that's the response rate therefore after radio chemo. And if you look at the response rate post durvalumab, then it's going down, but it's going down slower than the placebo arm. And here, you find the 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 did not get durva, 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 durvalumab. But this will be answered a bit later and potentially definitely answered when we will see the results of the Phase II beginning of next year.

Your next question comes from the line of Clemence Thiers from Stifel.

Just to come back to the CONVERGE study. Full data will be in early 2027. Is there any chance you or J&J could file based on that study? Or do you have to run a Phase III afterwards? That's the first question.

Thank you for the question. Well, first of all, we can talk for our partner. J&J now is running the CONVERGE 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 II. But if the data are excellent, everything is open. But again, that will be a J&J's decision to move that direction or to do a proper Phase III after that. But we will hope for the best.

Yes. That was worth the shot. And the second question, in 2026, we'll have all those additional data sets from your IO study and MD Anderson studies. Are those the last ones in the sense that will you be after that at the stage where you again J&J decide whether you move forward with it or not?

Yes. I think some of those trials have been completed like the melanoma cancer trial, the lung re-radiation and the last one, esophageal cancer. Just to know that we are now looking with MD Anderson as opening some potential new trial 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 hands of the J&J, but also discussing with us about potential next step, but nothing 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 reraadiation. 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.

Your next question comes from the line of Jonathan Chang from Leerink Partners.

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

Well, I think lung stage III cancer, like locally advanced head and neck cancer and other tumor are different because they are coming and they are in different organ, 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 PFS 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 J&J is going after if we think about the 2 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 populations that are also getting radiation. But it's always pure to demonstrate that this work 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 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 really 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. Now for lung cancer, there are many patients receiving radiation beyond lung Stage III. It is 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 will be J&J's decision to spread this product across different lung subpopulation.

We will take our next question. And the question comes from the line of Swayampakula Ramakanth from H.C. Wainwright.

This is RK from H.C. Wainwright. I also have a couple of quick questions on CONVERGE. So 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, does -- 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 we -- how do you and your partners see this being a successful therapeutic modality in the lung?

Well, first of all, about the bandwidth or the investment in lung versus head and neck. I think a Phase III is always bigger than the Phase II. And in that case, that's a very big Phase III versus the CONVERGE 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 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 JNJ-1900 or NBTXR3. But let's say that what we observe is they're pushing all front to make sure that all this could happen. Now on 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 met. 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 it through 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 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.

But RK, 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 JNJ-1900 is where we should play and where we should try to win.

One quick question on Curadigm. You did present some preclinical data previously. Now thinking -- going forward, since you also have collab 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 are pushing both because we think building our internal pipeline will go through 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.

We will take our next question. Your question comes from the line of Kiara Montoni from Van Lanschot Kempen.

This is [indiscernible] on for Kiara. So for the J&J driven Phase II trial in lung, do you expect that J&J will report an interim before the readout in early 2027? And if they do, what do you think they will most likely disclose the ORR or the post durvalumab from Part 1?

Thank you for the question. So yes, that's true. There are multiple readouts in this trial, different rate of response depending on timing, PD-L1 and also potential measurement as exploratory for other more systemic endpoints like PFS and OS. Now we can't talk for J&J. What we can say is what has been said publicly, which is the readout of the Phase II beginning of '27. But in between, who knows.

Okay. And 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?

We filed for different abstracts. If first one accepted, that should be around the summer.

We will take our next question, and the question comes from the line of David Dai from UBS.

Congrats on the progress. So a couple of questions from me as well. So just on the CONVERGE trial, so just thinking about the JNJ-1900, how do you think this early post-CCRT response we saw from the Part 1 could translate into durable load control and PFS benefit in Part 2? And I have a follow-up after that.

Well, I mean, that's depending 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 durvalumab. The good point is that, first of all, all of them went to durvalumab, which is not the case when you look at the overall population. And now we need to wait 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.

Got it. Okay. And then just on -- for next follow up, just on the Part 1 study here, will we expect another follow-up of this data from the Part 1? And also for the Part 2, which we're expecting to have some data in early 2027. Could you just help us understand a little bit more around what's the sort of expected data readout? Would it be OR? Or should we look at PFS as well?

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.

Your next question comes from the line of Michael Schmidt from Guggenheim.

I had a couple more on the CONVERGE data from yesterday. Obviously, very interesting. Could you confirm whether Part 2 of that study is enrolling? Or are still patients being added to Part 1, sort of the safety lead-in component of the trial?

Yes. Part 1 has been completed and the Phase II part, randomized part is enrolling since last year.

Okay. That makes sense. And then, yes, 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 III go decision? 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 III trial?

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 PACIFIC did show very little rate of CR, less than 1.7% in the post [indiscernible] treatment. But globally, patients, if you look at the dynamic of the curve, they're relapsing quite fast in [indiscernible] arm 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 III 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 [indiscernible] 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's J&J's 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, 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 in 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 J&J's team about optionality, there's nothing we can say at this moment.

So we'll keep our eyes out for any other updates.

[Operator Instructions] We will take our next question, and the question comes from the line of Shan Hama from Jefferies.

Just 2 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 a follow-up after.

I'm sorry, I'm not sure I got. 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 trial we've been running serve really as a base for discussion with them, and they can.

Okay. That's clear. And then just actually on cash burn. 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 runway 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, Janssen, we should expect to see development cost on the new platforms that Laurent talked to.

Your next question comes from the line of Clement Bassat from Portzamparc BNP Paribas.

I have 2. 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? 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 dose. So could you please provide some insight into the relationship between these 2 dose, if the relationship is linear or not? And if this could lead to narrowing the trend between these 2 dose due to the suspension of the liver clearance?

Let me try to address the question on the R&D spend and how that is proportion between our 3 new platforms. What I can share is that at this time, and this is relating to full year 2025, the spend on Curadigm 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.

So 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. So what the Nanoprimer does is by occupying transiently 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 targets that will not be able to reach normally. But if this product has a high liver toxicity, would prevent 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.

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 hope to see you all in a short for more news about Nanobiotix. 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.