Nanobiotix SA

Nanobiotix SA

23.72
EUR
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929.05MMarket Cap
Apr 27Next Earn

Q4 FY2025 · Earnings Call TranscriptApril 1, 2026

Operator

Good day, and thank you for standing by. Welcome to the Nanobiotix full-year 2025 financial results conference call.

At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session.

To ask a question during the session, you will need to press star one, one on your telephone. You will then hear an automated message advising your hand is raised.

To withdraw your question, please press star one, one again. Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Joanne Choi, Head of Investor Relations US. Please go ahead.

Joanne Choi

Thank you, Heidi. Good afternoon and good morning, and welcome to 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 US, which are available on the investor relations section of our website.

Any forward-looking statements made during this call reflect our views as of today and should not be relied upon as representing our views as of any subsequent date. Thank you.

I will now turn the call over to Laurent. Please go ahead.

Laurent Levy

Thank you, Joanne, and thank you, everyone. Good morning.

Good afternoon. Really happy to be here with you today to share our 2025 year and to give you a bit of perspective of what's going to happen in the next 12, 18 months.

Today we're going to go over different aspect 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. 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 term of future revenue for Nanobiotix.

While doing so, we've been also pivoting the company toward the new platform, which has been a big effort from the team, and I would like to thank them all for that. While doing those operational things in parallel, we've been able to really improve our cash visibility into 2028.

This beyond the timing of some of the expected milestones that should come from the collaboration with J&J. Altogether, we've had a rich year, and we are pleased to share that with you.

Now we're going to go in some more details to give you a bit of insight. Before getting there, we'd just like to to remind a few things about the philosophy with which we are developing things at Nanobiotix.

As you can see here, we mention delivering first-in-class therapeutics. 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 nanophymer, and also for the last platform, Curadigm.

That's really our philosophy. We don't want to do what other biotech are doing, not because it's bad, because we think there are enough people working on the same targets with the same technologies, we really want to bring something deep and different to help millions of patients.

That's what we're trying to do and we continue to do. Our strategy is simple and stay aligned with what we told you last year.

Is to continue to push and help J&J to address one of the potentially largest untapped market in oncology. That's through our first product, radioenhancer, that has been licensed to Johnson & Johnson.

Beyond this product, we're really pushing hard on new platform, starting with the Curadigm platform, which we think is going to disrupt part of how we think about drug development. We have been starting making good progress in that regard this year.

Obviously, we will come back to that in more details. Let's focus first on NBTXR3 or JNJ-1900.

What do we mean by addressing one of the largest untapped market in oncology? I think for that, we still need to look at patients.

When patients are diagnosed with cancer, the vast majority of them have a local disease. It's more than 70% of patient having a local disease at diagnosis.

Our industry in general is more focused on late-stage treatment of patient 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 a local stage.

That's exactly what we are trying to achieve with NBTXR3. For that, we're working with radiation therapy, which is one of the largest treatments used in oncology as more than 60% of all cancer patient are getting radiation.

We have a product that we licensed to J&J that fit this existing market with almost no competition. As you can see on this slide, we have a very large pipeline linked to this product that have been developing across many tumors.

Technically, that's just a few example of what could be done with this product, because there are many, many other patients getting radiation in different oncology indications. Let's try to look at where is the value here, what are the next key point of inflection, and how are we going to bring that to 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 hint of efficacy for those different indications.

Altogether, some consistency in the way you administer the product, but more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefit to patients. Let's focus on the two key developments.

As we've been transferring to Johnson & Johnson last year the ongoing Phase 3 in head and neck cancer. That's a very important trial as a Phase 3 and could lead, if positive, to first approval and first market activity around NBTXR3.

This trial is progressing well. J&J now has the full operation on this, and also the financial aspect of this trial are taken care of by J&J.

We still expect to get the first readouts of this trial the first half of next year. You may have noticed that on the top of this Phase 3, J&J has also started a Phase 1b in another population of head and neck, meaning patients getting radiation plus cisplatin.

If you think about head and neck cancer, with those two trials, you're technically capturing all the patients frontline that have a locally advanced tumor and that receive radiation and that cannot go to surgery. Technically, if you accept if you exclude, sorry, the few patients that have metastasis at diagnosis, with those two trials, you could capture the vast majority of head and neck cancer patients frontline treatment with the highest unmet medical need.

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 2 trial in unresectable Stage III non-small cell lung cancer. This trial is important for many reasons.

As you may have seen, lung cancer is a very important aspect of the strategy of J&J in oncology and is also, as a gigantic market, if not the biggest market with with breast cancer. Here, starting with this trial, assuming that the data are positive, what we feel at Nanobiotix is that could be a trigger for Johnson & Johnson to start expanding the development.

If we just stick to lung cancer, that's already a gigantic market per se. Here we're talking about Stage III, but it could expand into some other indications in lung cancer.

Maybe, as we did not have the occasion to talk about the data that have been generated, the first part of this data, let's have a small focus on that. As I've mentioned, we're talking here about patients that have a locally advanced unresectable Stage III lung cancer, and their treatment of reference is radiation plus chemo, followed by consolida- consolidi- consolidations with durvalumab.

As you can see, if you look left and right of this box, many other patients in lung cancer would receive radiation therapy frontline treatment, which could be at some point an expansion of the use of this product assuming that this trial bring positives. What's the design of the trial?

There's two part in it. First, a safety lead-in with very few patients, and then what we call a proof of concept with a randomized part of the trial where we compare the standard of care, chemo radiation with durva, versus the same plus the product with two different doses.

It is randomized 1:1:1. Total should have 120 patients.

Johnson & Johnson published that they should expect the readout of the randomi- randomized part beginning of 2027. The data that have been presented this week are about the safety lead-in, there's a lot of caveats around that.

It's a small number of patients, but nevertheless, we can start looking at what we observed here. We've been first showing a good safety profile with no serious adverse events linked to the treatment or the procedure, and 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 five out of seven 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 chemo for different reasons, including progression post radiation and chemo, which we did not observe so far in in this clinical trial.

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. We can say we've been progressing a lot with this collaboration.

Also now that we have transferred the Phase 3 to J&J, they are running most of the operations. We're still running and finishing the 1100 trial that has completed in term of recruitment.

Now there is some follow-up of patients, and we will continue to deliver some data in that regard. The collaboration with MD Anderson Cancer Center is still ongoing with many trials that have been completed in term of recruitment last year, where we're going to see data this year, and we may open to new trials with MD Anderson Cancer Center.

Maybe let's take time to talk a little about our new platform, Curadigm. Here, we're still talking about nanophysics.

We're still talking about nanoparticles, but with a different perspective, with different particles, with different potential benefit to the patient. Just as a reminder for those that are new on the call, as I see many, Curadigm is about trying to help many of the innovations we see in the biotech and the pharma arena.

You can notice that most of the new innovations 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 those objects, because being complex, at some point, when you try to inject inject them IV, the liver will play a role of filter and will capture a big part of them, if not all in certain cases.

For many of those innovations, it's very hard to have access to the entire body with a normal IV route. Rather than doing what our industry is usually doing, which is, let's try to tweak this object to make it more efficient and try to escape the liver while delivering at the right place, while delivering the payload and get the good transfection, for example, 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.

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 organ from the body. 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 a combination of all this.

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 four new patents application to continue to build our supremacy with this technology.

We also have presented positive new in vivo preclinical combination with different type of combination. More importantly, we're moving forward toward the IND, and we've started the CMC activity with the start of the GMP manufacturing and all sort of preclinical studies allowing to file for an IND.

While doing that at the internal program at Nano, we've been extending a lot our external reach out. We have now more than 20 MTAs that we've been signing with pharma or biotech where they have taken our product and they are testing it with one of their product to either improving the pharmacokinetic of this product or reducing liver toxicity.

We've done that with many different technologies for different therapeutic areas, like oncology, rare disease, CNS disorder. It's moving quite well, and then we thank expect, in a not too distant future, to start transforming some of those MTAs into deals.

Globally, the way we see the value of this platform and the three pillars that we are using to push it is, first, continue to build and protect the technology while building an internal pipeline. We want to have our fully owned product to be developed up to a certain stage while we are building or piling up deals with different partner, pharma and biotech.

Of course, because of all this, we need to prioritize and build the right infrastructure to be able to build, to manufacture, and to provide this product to many partners and to our internal pipeline. Things are moving well, and we expect to get a bit more update and new data on this platform coming before the end of the summer.

Just of note, last year, we've been entering a new index on the Euronext market, which is the SBF 120, and that's an index that covers the 120 largest French listed companies by market and cap liquidity. 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.

I'm going to take this to give the mic to Bart to talk about the financial part of this presentation.

Bart Van Rhijn

Thank you, Laurent. Good morning, good afternoon, everyone, and thank you for joining us today.

Over the past year, we've materially strengthened the company's financial foundation, positioning us to advance through 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 Janssen in a way that materially improves our financial profile. Under the revised terms, we have removed the vast majority of our funding obligations for the Phase 3 NANORAY-312 study while retaining significant upside through milestone payments that could total hundreds of millions 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 through the securing of a non-dilutive royalty financing with HealthCare Royalty Partners for up to $71 million.

This transaction provides incremental capital while avoiding shareholder dilution, extends our projected cash runway into early 2028, excluding potential milestone inflows. 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 of financing alternatives. 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 partnerships reflects a high degree of alignments around the long-term potential of JNJ-1900 and our broader strategic objectives. Critically, this royalty structure ensures that our partner's return is directly linked to the success of our lead program, which aligns incentives while avoiding repayment obligations beyond the nominal value of the bonds.

Moreover, this is a construct that is capped 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 toward long-term sustainability and profitability.

Moving over to our full-year financial highlights. For the full year 2025, we recognized positive revenue of €32.6 million compared to negative €7.2 million for the year ended 2024.

As a reminder, the negative revenue recorded in 2024 was primarily driven by one-time recognition of the net liability to Janssen following the transfer of the sponsorship of the NANORAY-312 study. The positive revenue recognized in 2025 reflects a one-time accounting impact of €21.8 million associated with the amendments to licensing agreements 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 non-recurring.

Said differently, as these changes in 2024 and 2025 were considered purchase price adjustments from an accounting point of view, these results flowed 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 €23.1 million for the 12-month period ended December 31, 2025, which compares to €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 developments across our clinical and preclinical programs while maintaining investment in key manufacturing and pipeline activities, supporting the long-term advancements 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 slightly down year-over-year at €20.4 million compared to €20.5 million, reflecting continued expense control. Net loss attributable to shareholders was €24 million or 50 euro cents 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 a 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, Nanobiotix anticipates that the cash and 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 balance sheet resiliency and believe the foundation we have built positions us well for the periods ahead as we work to deliver long-term value for our stakeholders.

Thank you. Now I would like to turn the call back to Laurent.

Laurent Levy

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 will 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 3 in first half of '27 and the results of the Phase 2 in lung cancer in early 2027. Beside this, this year, we're going to deliver four different results of clinical trials, which three of them have been completed, 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 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 indication, which reinforce the potential value of this product.

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 are 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.

As you've 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

Thank you. As a reminder, to ask a question, you will need to press star one, one on your telephone and wait for your name to be announced.

To withdraw your question, please press star one, one again. We will take our first question.

Your first question comes from the line of Tara Bancroft from TD Cowen. Please go ahead.

Your line is open.

Tara Bancroft

Hi, good morning, or good afternoon for you guys. My question is about the lung data that you guys showed from CONVERGE yesterday.

They were really interesting even if it's only in the first seven patients. We were hoping you could give us some context for how you benchmarked that to the 45% to 50% ORR.

We ask because PACIFIC seems to be the best comp here where ORR was actually around 30%. Just curious to hear your thoughts on that.

Then on follow-up, when were these assessments taken that were in the poster? How does that length of follow-up so far play into your level of confidence in the data that could potentially improving even further in part two?

Thanks so much.

Laurent Levy

Thank you, Tara. I think there are a few paper or historical control we could look as comparator for that.

As a context, we're 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% would be randomized, two patients in the direction of durva, one with placebo.

There is in the evaluation of the response rate in the PACIFIC paper something telling 40%, 48% patient percent of response, but that exclude the 30% patients that have been not treated after that with durvalumab. That's the response rate they found after radiochemo.

If you look at the response rate post durvalumab, then it's going down, but it is going down slower than the placebo arm. Here you find the 27% response that you probably mentioned.

Again, this 27% response is excluding the patients that have been frontline excluded from the trial before randomization. Altogether, if we take 40%, 50%, that's what we can find in some other paper as what radiation plus chemo is doing for those patients and close to what they find as an optimization in the PACIFIC regimen.

I think that's just the first part. The most important part is how this evolve over time, because what we see in PACIFIC, some patients did not get durva, 30%, and then the rate is going down over time.

I think if R3 can provide a real local control, then we should see something different happening versus what you can observe with durvalumab. This will be answered a bit later and potentially definitely answered when we'll see the results of the Phase 2 beginning of next year.

Tara Bancroft

Great. Thanks.

Laurent Levy

Thank you, Tara.

Operator

Thank you. We will take our next question.

Your next question comes from the line of Clémence Thiers from Stifel. Please go ahead.

Your line is open.

Clémence Thiers

Thank you, and thank you for the presentation. Just to come back to the CONVERGE study.

Full data will be in early 2027. Is there any chance you or J&J could file based on that study, or do you have to run a Phase 3 afterwards?

That's the first question.

Laurent Levy

Hi, Clemens. Thank you for the question.

We can't 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.

I think it's a bit early to talk about that. That may be a question we could ask when we see the data coming from the Phase 2.

If the data are excellent, everything is open. Again, that would be a J&J's decision to move that direction or to do a proper Phase 3 after that.

Clémence Thiers

Let's hope for

Laurent Levy

the best.

Clémence Thiers

Okay. That was what I thought.

The second question, in 2026, we'll have all those additional datasets from your IST study and the Anderson studies. Are those the last ones in the sense that will you be after that at a stage where you or again J&J decide whether you move forward with it or not?

Laurent Levy

I think some of those trials have been completed, like the melanoma cancer trial, the lung re-irradiation, and the last one esophageal cancer. Just to know that we are now looking with MD Anderson at opening some potential new trials to explore new avenues.

That's something that will come a bit later. Obviously, out of all those trials, we got a lot of signs of safety, feasibility, potential good efficacy for the product.

Now it's within the hand of J&J, but also discussing with us about potential next steps, but nothing that we can say at this stage. If I have one mention to do is to maybe take a particular look at the MD Anderson cancer trial about lung re-irradiation.

This trial, the recruitment has been completed last year, and we'll see the final data this year on more patients with more follow-up. I think this trial is very important because it's not like the same population that is treated in CONVERGE, but to a certain extent could be seen as a surrogate of what we could observe in CONVERGE.

We will pay particular attention to this trial, but also will bring that to your attention.

Clémence Thiers

Okay. Thank you very much.

Laurent Levy

Thank you, Clemens.

Operator

Thank you. We will take our next question.

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

Your line is open.

Albert Agustinus

Good morning, good afternoon. This is Albert Agustinus on for Jonathan Chang.

Congrats on all the progress and thanks for taking my question. My question also reflects on the CONVERGE data.

How do we extrapolate these results to your other ongoing trials and potential indications? Secondly, if I may, how do you foresee JNJ-1900 will be positioned within the landscape of non-small cell lung cancer treatment paradigm?

Thank you.

Laurent Levy

Thank you. I think lung Stage III cancer, like locally advanced head and neck cancer and other tumors, are different because they're 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.

What our product does is improving the absorption of energy, killing more cells. We know when you have a local disease, killing more cells may lead to more control.

That's the basic thesis that led us to start developing NBTXR3 and going into frontline treatment when patient has a local disease. That's also what J&J is going after if we think about the two trials in head and neck and this trial in lung cancer.

For us, it does establish the strong power of having local control transforming into benefit for patients. Starting from this point, then we could anticipate or imagine a diffusion of this product across different population that are also getting radiation.

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. 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.

That's a good start to any tumor type. If we think about how extrapolate to other indications, that could be a path.

Now for lung cancer, there are many patients receiving radiation beyond lung Stage III. It's around 77% of lung cancer patients getting radiation.

Not to mention that small cell lung cancer is also another indication where radiation is key. We could imagine, but again, that would be a J&J's decision to spread this product across different lung subpopulation.

Albert Agustinus

Thank you.

Laurent Levy

Thank you.

Operator

Thank you. We will take our next question, and the question comes from the line of Swayampakula Ramakanth from H.C.

Wainwright. Please go ahead.

Your line is open.

Swayampakula Ramakanth

Thank you. This is RK from H.C.

Wainwright. Good afternoon, Laurent, Bart, and Joanne.

I also have a couple of quick questions on CONVERGE. 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?

Additionally, do you have any data from your partner regarding abscopal effect in the lung? Because injecting into lung lesions are potentially technically challenging, how do you and your partner see this being a successful therapeutic modality in the lung?

Okay.

Laurent Levy

Thanks, RK. About the bandwidth or the investment in lung versus head and neck, I think a Phase 3 is always bigger than a Phase 2, and in that case, that's a very big Phase 3 versus the CONVERGE trial, there's much more people working on one than the other, which is normal given the size of things.

The attention is equally important from our perspective and what we can observe. 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.

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 lesions. That's something we start observing in many different clinical situations that would be very useful to understand and to investigate when we think about metastatic patients.

For the vast majority of patients getting radiation, they have no met. They have a local or locoregional disease, and here local control is much more important than any potential immune response.

If we can provide it through local injection of the particle plus the radiation, that could be a win. In the case of locoregional, when some of the lymph nodes 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.

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 locoregional disease where radiation plays a role, usually the locoregional 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. 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.

Swayampakula Ramakanth

Thank you for that. One quick question on Curadigm.

You did present some preclinical data previously. Now thinking going forward, since you also have 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?

Laurent Levy

We're 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.

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 product that are already into clinical development. That will not only push forward our pipeline, but also will open many more opportunity for collaboration and licensing out.

Swayampakula Ramakanth

Thank you. Thanks for taking all my questions.

Laurent Levy

Thanks, RK.

Operator

Thank you. We will take our next question.

Your question comes from the line of Chiara Montarone from Van Lanschot Kempen. Please go ahead.

Your line is open.

Hi, this is Sandrine on for Chiara. Thank you for taking our question.

For the J&J driven Phase 2 trial on lung, do you expect that J&J will report an interim before the readout in early 2027? If they do, what do you think they will most likely disclose, the ORR or the post durvalumab from part one?

Laurent Levy

Thank you for the question. Yes, that's true.

There's multiple readouts in this trial, different rate of response depending on timing, pre or post durva, and also potential measurement as exploratory for other more systemic endpoint 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 2 beginning of '27. In between, who knows?

Thank you. On the MD Anderson lung re-irradiation trial, you said you expect it to read out in 2027.

Is there any possibility you can narrow down on the timing?

Laurent Levy

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

Okay. Thank you so much for taking the question.

Laurent Levy

You're welcome. Thank you for the question.

Operator

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

Please go ahead. Your line is open.

Oh

David Dai

great, yeah. Thanks for taking my questions and congrats on the progress.

A couple of questions from me as well. Just on the CONVERGE trial, thinking about the JNJ-1900, how do you think this early post-CCRT response saw from the part one could translate into durable local control and PFS benefit in part two?

Then I have a follow-up after that.

Laurent Levy

That's depend on how durable will be the response. As 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 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.

Now we need to wait the next set of data to conclude on that. If we believe of what we have seen previously in other trials, we should expect a much greater local control.

Now we'll see how this potentially impact a more systemic aspect of things for the patients.

David Dai

Got it. Thanks Laurent.

Then just on the part one study here, will we expect another follow-up of this data from the part one, and also for the part two, which we're expecting to try to have some data in early 2027, could you just help us understand a bit more around what's the sort of expected data readout? Would it be ORR, or should we look at them PFS as well?

Laurent Levy

I don't know. What we know is that all this that you mention are endpoint of the trials, but we don't know what J&J is going to communicate yet.

All right.

David Dai

Thank you so much for taking my questions.

Laurent Levy

Thank you, David.

Operator

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

Please go ahead. Your line is open.

Michael Schmidt

All right, 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, sort of the safety lead-in component of the trial?

Laurent Levy

Part one has been completed, and the Phase 2 part, randomized part, is enrolling since last year.

Michael Schmidt

That makes sense. Then, yeah, assuming that the sort of next update in early 2027, is your impression that this is sufficient for your partner to potentially make a Phase 3 go decision, or do you think more follow-up maybe needed to look at things like DFS or maybe even OS to make that move into a large Phase 3 trial?

I think that

Laurent Levy

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 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-durva treatment. Globally, patient, if you look at the dynamic of the curve, they're relapsing quite fast in durva arm and versus radio plus chemo.

I think comparing all those data, we can't say if you beat that bar then you move to Phase 3 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 durva, because usually 30% are not; number of patients getting response; number of patients getting complete response; and then you can start following PFS and OS to see.

A combination of all this or just few of them, depending on the magnitude, could be enough. At the end, that's J&J's decision to look at this and to take the path moving forward.

Michael Schmidt

Makes sense. Then another one, I know this maybe 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 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?

Laurent Levy

That's a tricky question we can't answer. What we can say is you can see the priorities of J&J in term of indications, like lung, bladder, head and neck, and so on.

As you mentioned, breast cancer is not part of those priorities. Also, we have all the trials we've been running or are still running with MD Anderson that could serve as a base for expansion.

Even though we have a lot of discussion with J&J's team about optionalities, there's nothing we can say at this moment.

Michael Schmidt

We'll keep our eyes out for any other updates there. Thank you for the updates.

Really appreciate it.

Laurent Levy

Thank you, Michael.

Operator

Thank you. Once again, if you wish to ask a question, please press star one, one on your telephone.

We will take our next question, and the question comes from the line of Shan Hama from Jefferies. Please go ahead.

Your line is open.

Shan Hama

Hi guys. Thanks for taking my my questions.

Just two for me, please. Actually, just just on potential indication expansion on on J&J's part.

I know there's obviously not not much you can comment on their behalf, but the indications that MDA is working on, is there scope for J&J to actually expand the R3 R3 program into those indications, pancreatic, esophageal, etc.? That's my first question, and then I can ask the follow-up after.

Laurent Levy

I'm sorry, I'm not sure I got the question was, can they or will they?

Shan Hama

As in can they? Are they able to?

Laurent Levy

Okay. Yes, of course.

They are able to, and obviously all the clinical trials we've been running serve really as a base for discussion with them. They can.

Shan Hama

That's clear. Then just actually on cash burn.

Obviously R&D's come down pretty sharply post the transfer to J&J. What's the sort of steady state annual cash burn we should assume through to 2027?

Bart Van Rhijn

Thank you for the question. We don't provide specific forward-looking guidance to the individual years, and we refer to the cash runway that is in early 2028.

We have a very disciplined approach to how we allocate capital. What you've been used to in the past few years, you should expect to continue to see from us.

Maybe one high-level comment is that as the 312 costs have been transferred to our partner Janssen, we should expect to see development costs on the new platforms that Laurent talked to.

Shan Hama

Got it. That's really clear.

Thank you so much.

Laurent Levy

Thank you.

Operator

Thank you. Your next question comes from the line of Clément Bassat from Portzamparc BNP Paribas.

Please go ahead. Your line is open.

Clément Bassat

Hi, good morning, Laurent, Bart. Thank you for the presentation and for taking my questions.

I have two. First, I was wondering how much R&D you spent in oncology in H2 and how much was allocated to Curadigm just in order to assess the shift?

Secondly, regarding the mechanism of Curadigm, my understanding is that with the Nanoprimer, we reduce the effective dose level, but at the same time, we may also reduce the lethal dose. Could you please provide some insight into the relationship between these two dose, if the relationship is linear or not, and if this could lead to narrowing the spread between these two dose due to the suspension of the liver clearance?

Thank you.

Bart Van Rhijn

Let me try to address the question on the R&D spend and how that is proportioned between R3 and 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. For the past year, it was a smaller amount compared to the total R&D spend.

Clément Bassat

All right, good.

Laurent Levy

Hi, Clément. To your second question about Curadigm, I think the answer is yes, there is a correlation, but will depend also on the need of the product.

Let me try to get to that. What the Nanoprimer does is by occupying transiently the liver, it will allow a second product to circulate more freely.

If this product had a strong accumulation in liver, but not much toxicity, what you're going to play on is the ability for the second product to circulate more freely and to reach other target that would not be able to reach normally. If this product has a high liver toxicity which 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.

There's always a correlation between the dose of the Nanoprimer and the quantity that you will avoid to be captured in the liver and the quantity that will be allowed to circulate. There is a link to that.

Different product 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.

Clément Bassat

All right. Thank you.

Laurent Levy

Thank you, Clément.

Operator

Thank you. This concludes today's question-and-answer session.

I'll now hand back for closing remarks.

Laurent Levy

Everyone, thank you very much. Was a pleasure, as usual, to talk to all of you.

I've seen that you are numerous today assisting to the call. It's a very good thing.

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.

Bart Van Rhijn

Thank you all.

Operator

This concludes today's conference call. Thank you for participating.

You may now disconnect.