Nanobiotix S.A.

day and thank you for standing by. Welcome to the Nanobiotics Full Year 2025 Financial Results Conference Core. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joanne Choi, Head of Investor Relations U.S. Please go ahead.

Thank you, Heidi. Good afternoon and good morning. And welcome to the Nanobiotics Conference Call to discuss our full year 2025 financial and operational results. Joining me on the call today are Laurent Levy, co-founder and chief executive officer, and Bart Van Ryn, chief financial and business officer. Today's call is being webcast and will be available on our website for replay. Before we begin, I would like to remind you that today's discussion will include four looking statements within the meaning of applicable securities laws. These statements are based on our current expectations, assumptions, and available information and are subject to significant risks and uncertainties that could cause actual results to differ materially. Such risks include, among others, those related to the timing, progress, and outcomes of our research and clinical development programs, regulatory developments, and our financial and operational performance. We encourage you to review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the U.S. which are available on the investor relations section of our website. Any forward-looking statements made during this call reflect our views as of today and should not be relied upon as representing our views as of any subsequent date. Thank you. I will now turn the call over to Laurent. Please go ahead.

Thank you, Joanne, and thank you, everyone. Good morning, good afternoon. Really happy to be here with you today to share our 2025 here. and to give you a bit of perspective of what's going to happen in the next, well, 18 months. So today we're going to go over different aspects of things, how we've been moving the company for the past year and also give some financial highlight and then open for Q&A session. I think we've had a very rich 2025. We've been able to do many things during this year. First of all, start moving forward in a good way the collaboration we have with Johnson & Johnson. and start showing the potential of this first product along with the potential of this deal in terms of future revenue for nanobiotics. While doing so, we've been also pivoting the company towards the new platform, which has been a big effort from the team, and I would like to thank them all for that. While doing those operational things in parallel, we've been able to really improve our cash visibility into 2028. and this beyond the timing of some of the expected milestones that should come from the collaboration with GMJ. So all together, we've had a rich year and we're pleased to share that with you. And now we're going to go into some more details to give you a bit of insight. Before getting there, we'd just like to remind a few things about the philosophy with which we are developing things at Nanobiotics. So as you can see here, we mentioned delivering first-in-class therapeutically, but I think Definitely, we're doing more than this. We're creating new class of drugs. That's what we have done for the radio enhancer, for the nanoprimer, and also for the last platform, OQT. And that's really our philosophy. We don't want to do what other biotechs are doing, not because it's bad, because we think there are enough people working on the same target with the same technology. So we really want to bring something deep and different to help millions of patients. And that's what we're trying to do, and we continue to do. Our strategy is simple and stays in line with what we told you last year. First of all, it's to continue to push and help GMJ to address one of the potentially largest untapped markets in oncology. And that's through our first product, RadioAnswer, that has been licensed to Johnson & Johnson. And beyond this product, we're really pushing hard on new platforms, starting with the CuraDyn platform. which we think is going to disrupt part of how we think about drug development. And we have been starting making good progress in that regard this year. Obviously, we will come back to that in more detail. But let's focus first on NBTSR3 or J&J 1900. What do we mean by addressing one of the largest untapped markets in oncology? Well, I think for that, we still need to look at patients. And when patients are diagnosed with cancer, the vast majority of them have a local disease. It's more than 70% of patients having a local disease are diagnosed. And our industry, in general, is more focused on late-stage treatment of patients when they get metastatic or have received several lines of treatment. If you think about it, if you want to have a big impact for those patients, It will be much better, if possible, to treat them at the beginning of their disease and try to eradicate the tumor when it's still at the local stage. And that's exactly what we are trying to achieve with NBT-XR3. And for that, we're working with radiation therapy, which is one of the largest treatments used in oncology, as more than 60% of all cancer patients are getting radiation. And we have a product. that we licensed to GMJ that fit this existing market with almost no competition. And as you can see on this slide, we have a very large pipeline linked to this product that have been developing across many tumor. And technically, that's just a few examples of what could be done with this product because there are many, many other patients getting radiation in different oncology indications. But let's try to look at where is the value here, what are the next key points of inflection, and how are we going to bring that to next steps. This year, last year, sorry, 2025, we've been publishing additional data in different cancer types. On the top of the already established proof of concept in soft tissue sarcoma, the first data in head and neck cancer, we've been able to continue to show that this product could be widely applicable in oncology. Through 2025, we've been publishing data on head and neck cancer by talking here about the recurrent metastatic patients, also pancreatic cancer, esophageal cancer, melanoma cancer, and lung cancer. All this data I've been showing not only that you could use safely NBTSR3 in different indications, but also start to show some potential good of efficacy for those different indications. And altogether, some consistency in the way you administer a product, but more importantly, in the way this product could amplify the radiation therapy and potentially bring new benefits and additional benefits to patients. But let's focus on the two key developments. As you know, we've been transferring to Johnson & Johnson last year the ongoing phase three in head and neck cancer. That's a very important trial as a phase three and could lead, if positive, to first approval and first market activity around NBT-XR3. This trial is progressing well. J&J now has the full operation on this and also the financial aspect of this trial AfricanCare by J&J, and we still expect to get the first readout of this trial the first half of next year. You may have noticed that on the top of this phase three, J&J has also started a phase 1b in another population of head and neck, meaning patients getting radiation plus cisplatin. If you think about head and neck cancer, with those two trials, you're technically capturing all the patients frontline that have a locally advanced tumor and that receive radiation and that cannot go to surgery. So technically, if you exclude the two patients that have metastasis at diagnosis, with those two trials, you could capture the vast majority of NMN cancer patients, first-line treatment with the ISM-MED medical trial. So that's a very important pathway and could, if positive, establish NB-TXR3 as a key player in all head and neck cancer treatment. Now, there is another trial which is equally important and potentially even more important. We're talking about here the first lung cancer trial that Jiang Xia is running. The name of this trial is CONVERT. It's a randomized phase two trial in unresectable stage three non-small cell lung cancer. This trial is important for many reasons. First of all, as you may have seen, lung cancer is a very important aspect of the strategy of J&J in oncology. And it's also, as you know, a gigantic market, if not the biggest market with breast cancer. So here, starting with this trial, assuming that the data are positive, what we feel at Nanobiotics is that could be a trigger for Johnson & Johnson to start expanding the development. But if we just speak to lung cancer, that's already a gigantic market per se. Here we're talking about stage 3, but it could expand into some other indication in lung cancer. And maybe as we did not have the occasion to talk about the data that had been generated, the first part of this data, let's have a small focus on that. As I mentioned, we're talking here about patients that have a locally advanced unresectable stage 3 lung cancer, and their treatment of reference is radiation to chemo, followed by consolidations with geobalance. And as you can see, if you look left and right of this box, many of the patients in lung cancer would receive radiation therapy from client treatment. which could be at some point an extension of the use of this product, assuming that this trial reads positive. So what's the design of the trial? There's two parties. First, a safety leading with very few patients, and then what we call a proof of concept with a randomized part of the trial where we compare the standard of care, chemoradiation with DERVA, versus the same plus the product with two different dose. And this is randomized one-to-one-to-one. Total should have 120 patients. And Johnson & Johnson established that they should expect the readout of the randomized path beginning of 2027. The data that have been presented this week are about the safety leading. So there's a lot of caveat around that. It's a small number of patients, but nevertheless, we can start looking at what we observed here. So we've been first showing a good safety profile with no serious adverse events linked to the treatment or the procedure, and the feasibility of injection in every patient. Then what has been observed is a good first rate of response that we could see, as we've seen 5 out of 7 patients responding, and equally importantly, we get 100% disease control. meaning that all those patients went to durovalumab, which is not the case if you look at the details of Pacific trials. Many patients have been excluded post-radiation chemo for different reasons, including progression post-radiation chemo, which we did not observe so far in this clinical trial. But altogether, what we can say is a first readout encouraging, and we can wait to see the next steps of this or the final data that should come as we mentioned beginning of 2027. So we can say we've been progressing a lot with this collaboration. Also now that we have transferred the phase three to J&J, They're running most of the operation. We're still running and finishing the 1,100 trials that have completed in terms of recruitment. Now there is some follow-up of patients, and we will continue to deliver some data in that regard. And the collaboration with MD Anderson Cancer Center is still ongoing with many trials that have been completed in terms of recruitment last year. We're going to see data this year. and we may open to new trials with the MD Anderson Cancer Center. But maybe let's take time to talk a little about our new platform, CuraLac. Here, we're still talking about nanophysics, we're still talking about nanoparticles, but with a different perspective, with different particles, with different potential benefits to the patient. Just as a reminder, for those that are new on the call, as I see many, Curadive is about trying to help many of the innovations we see in the biotech and the pharma arena. You can notice that most of the new innovation coming out, people are building more and more complex objects. We can talk about oncolytic virus, RNA-based therapy, in vivo CAR T, cell therapies, and all the subjects, because being complex, At some point, when you try to inject them IV, the liver will play a role of filter and will capture a big part of them, if not all, in certain cases. So for many of those innovations, it's very hard to have access to the entire body with a normal IV route. So rather than doing what our industry is usually doing, which is let's try to tweak this subject, to make it more efficient and try to escape the lever while delivering at the right place, while delivering the payload and get the good transaction, for example. So you're building a lot of compromise in one object. With the PureLAMP technology, we decided to build what we call a nanoprimer, a second object. This nanoprimer is injected prior to the second product, and this nanoprimer has been specifically designed to transparently getting into the liver and get it occupied for a certain amount of time. So while the liver is busy, when you inject the second product, then it is much less captured by the liver and can have access to many other organs from the body. So what you could do with this approach is improving pharmacokinetics of a product, allowing, when it's not possible, to escape the liver, reducing liver toxicity, or a combination of all these. So there are many, many opportunities and many, many applications we could do with this technology. And now a big part of the theme is focused on the development of it. What we've been doing lately is really continuing pushing, meaning filing for four new patents applications to continue to build our supremacy with this technology. We also have presented positive new in vivo preclinical combination with different type of combination. And more importantly, we are moving forward toward the IND and we started the CMC activity with the start of the GMP manufacturing and also the preclinical studies are going to file for an IND. And while doing that, at the internal program at Nano, we've been expanding a lot our external reach-outs. We have now more than 20 NTS that we've been signing with pharma or biotech where they have taken our product and they are testing it with one of their products to either improving the pharmacokinetics of this product or reducing liver toxicity. And we've done that with many different technologies for different therapeutic areas like oncology, rare disease, CNS disorder. So it's moving quite well. And then we expect an up-to-date future to start transforming some of those NTAs into deals. But globally, the way we see the value of this platform and the three pillars that we are using to push it is first, continue to build and protect the technology while building an internal pipeline. We want to have our fully-owned product to be developed up to a certain stage. while we are building our piling up deals with different partners, pharma and biotech. And of course, because of all this, we need to prioritize and build the right infrastructure to be able to build, to manufacture, and to provide these products to many partners and to our internal pipeline. So things are moving well, and we expect to get a bit more data and new data on this platform coming before the end of the summer. Just of note, last year we've been entering a new index on the Euronext market, which is the SDF 120, and that's an index that covers the 120 largest French listed companies by market and cap liquidity. So it does give us a bit more institutional visibility and we've seen through that some of the new investors coming on the top of specialized biotech investors that have entered Allstock last year. And I'm going to take this to give the mic to Bart to talk about the financial part of this presentation.