Good day, and welcome to the Nanobiotix Corporate Strategy Update and Q1 2024 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. At this point, I will turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotix. Thank you. Good afternoon, and good morning, and welcome to the Nanobiotix conference call to discuss updates to our NBTXR3 development plan and our first quarter. Joining me on the call today are Laurent Lévy, Co-founder and Chief Executive Officer, and Bart van Rhijn, Chief Financial Officer, who will be available during the Q&A section. As a reminder, today's call is being webcast and will be available on our website for replay. I would like to remind you that this call will include forward-looking statements, which may include statements regarding the progress, success, and timing of our ongoing and planned clinical trials, collaborations, regulatory filings, dates of presentation, and future research and development efforts, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. They are subject to significant risks and uncertainties that could cause the company's actual results to differ materially from our current expectations. Accordingly, you are cautioned not to place undue reliance on forward-looking statements. Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and SEC in the United States, which are available in the investor relations section of our website, along with the press releases issued yesterday and today. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, Nanobiotix undertakes no obligation to update them to reflect subsequent events or future circumstances. Before turning the call over to Laurent, allow me to highlight that we announced in a separate press release this morning our first quarter 2024 unaudited cash balance of EUR 58.9 million, and reaffirmed our cash runway into Q3 2025, which is inclusive of the $20 million milestone we meanwhile received. With that said, I'd like to turn the call over to Laurent. Please go ahead. Thank you, Craig, and thank you everyone for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company progress in the global development of NBTXR3 and an overview of our robust pipeline and expansion strategy. For today's call, I would like to begin with updates to our NBTXR3 collaboration and discuss our pathway to long-term growth. Then, I will provide closing remarks before opening up the call for question. Nanobiotix has been long known for the disruptive potential of NBTXR3, a nanoparticle treatment we've been developing for patients with cancer around the world. The accomplishments we have achieved through our 20-year history stand as a testament to the hard work of our team, the potential value the industry at large sees in our technology, as well as the tremendous faith and confidence of our investors and other stakeholders holding our vision and our plans to get there. Last summer, we entered into a collaboration with Janssen, worth potentially more than $2.5 billion+ royalties, ranging from low teens-low twenties, to expand the worldwide potential of our lead therapeutic candidate, NBTXR3, a potential first-in-class radiotheranostic with universal application across solid tumor. As part of the agreement, NBTXR3 is being developed and potentially commercialized globally by Janssen Pharmaceutica, a Johnson & Johnson company. Our global license agreement with Janssen has brought us the possibility to deliver outcome-changing innovation for millions of patients. Today's focus with our partner is to secure the path to market for NBTXR3, and our commitment to realize our radiotheranostic medical and economic value remains our most important goal. We believe this agreement underscores the therapeutic and market opportunity of NBTXR3, and importantly, further validates our platform and scientific approach. We believe that this collaboration with our partner has the potential to impact the lives of many patients. We believe this because NBTXR3 can treat patients at stage where the disease is local, with radiation therapy, which is a treatment utilized by millions of patients. Better local control of disease at this stage, we believe, could have a fundamental impact on the overall outcome for patients. The alliance with Janssen for the co-development and global commercialization of NBTXR3 has achieved significant progress, which we will overview today. We remain focused on the execution to secure our partnership outcomes and drive as much value in the alliance as possible for patients and Nanobiotix's many stakeholders. Alongside this, Nanobiotix is working to explore and push forward the next generation of nanoparticle-based therapy in healthcare. I'm excited to discuss with you today our corporate strategy, which is designed to enable long-term growth for Nanobiotix. Our company is developing three nanoparticle-based therapy platform. We plan to leverage the sustainable revenue expected to come from the development and commercialization of NBTXR3 to further advance development of our second platform, Curadigm, and the third platform... Building on the success of NBTXR3, we are energized to expand our leadership in nanoparticle-based therapy, and we'll discuss more on this shortly. First, let's start with our effort to deliver a potentially curative outcome for patients with locally advanced and metastatic cancer with NBTXR3, as it remains our primary focus. As a reminder, or for those new to the story, NBTXR3 is a biologically inert, electron-dense nanoparticle designed to be a strong X-ray absorber and radiation amplifier. It is a one-time treatment designed to minimize impact on the patient journey, as it is injected directly into the tumor before the first course of radiation treatment, where it has been shown to amplify the antitumor activity of the radiation without increasing exposure to healthy tissue. We call this mode of action universal. We do so because it's based on physics, and all radiation interacts with the nanoparticle and not on the specificity of the tumor type or the biology of the patient. This mode of action also lends itself to NBTXR3's ability to combine with many other modes of therapy, including chemotherapy regimen, targeted therapy, and importantly, immuno-oncology therapy. NBTXR3 is being evaluated as a therapeutic candidate with potential to easily integrate into the cancer treatment paradigm for 60% of solid tumor patients who receive radiation as part of their therapeutic regimen each year. To date, NBTXR3 has been injected in hundreds of patients by leading physicians at several pre-eminent clinical research institutions in the United States, Europe, and Asia. To help enable the practice-changing potential of NBTXR-3, in collaboration with the Interventional Oncology Group at Johnson & Johnson, the current NBTXR-3 development program is initially focused on the completion of NANORAY-312, an ongoing pivotal phase III, evaluating the radioenhancer for elderly patients with locally advanced head and neck cancer, as well as the launch of a randomized phase II study evaluating NBTXR-3 for patients with Stage III non-small cell lung cancer, for which Janssen is fully responsible. In preparation for potential regulatory submission in the event of a positive head and neck trial result, Nanobiotix and Janssen align at the collaboration's Joint Strategy Committee, or JSC, to transfer the global sponsorship of the phase III pivotal head and neck cancer trial. Nanobiotix will continue to support Janssen in the execution of the NANORAY-312, during and after the sponsorship transfer is complete. This was a deliberate decision to pursue the transfer sooner rather than later, because we believe it's the best decision for the product value and its efficient path to market. In conjunction with the sponsorship transfer, following discussions that began in late 2023, the Joint Strategy Committee aligned to modification to NANORAY-312 that include a protocol amendment, removing the planned futility analysis in light of the robust positive top-line data from the expansion part of the Study 102, a phase I study evaluating NBTXR3 in similar population, which provided satisfactory support for the NANORAY-312 trial design, which deemed the futility analysis not useful. This amendment is subject to review and approval by health authorities in all countries where NANORAY-312 is operational, as well as by the site participating in the study. To date, the amendment has been accepted by health authority in several regions, including United States, countries in Europe, and Japan. Additionally, Nanobiotix and Janssen agreed to a change in the approach to the planned interim efficacy analysis, such that Janssen will realize and report on the interim data after both the requisite number of events are observed and at the end of the recruitment has occurred, which is expected in the first half of 2026, rather than immediately after the requisite number of events as originally planned. This revised approach helps to ensure that potentially positive interim analysis results do not introduce a potential bias in the remaining recruitment prior to completion of the study. As such, Nanobiotix now expect the interim analysis to be reported after the last patient is recruited in H1 2026. Now, let's review other significant progress on our NBTXR3 collaboration with Janssen in establishing development operation since executing the global licensing agreement this July. We started with the formation of the Joint Strategy Committee, comprised equally of executives from both companies, to drive strategic decision-making for the global development program. We also activated joint working teams that are staffed by both companies, with an initial focus on manufacturing and preparing NANORAY-312 for global regulatory submission in the event of positive trial results. In addition to establishing governance methods, key operational progress have been achieved. Highlights include, first, Janssen has begun replicating the Nanobiotix manufacturing process to allow Johnson & Johnson to produce NBTXR3 in parallel with our own facility in order to increase product availability. Second, we have started to leverage increased discretionary in-kind contributions that were allocated from Janssen to Nanobiotix. That includes staff support for NANORAY-312, along with payment for manufacturing, technical assistance, and other product development support services. Third, we achieved the first operational milestone in NANORAY-312, triggering a $20 million payment in May from Janssen to Nanobiotix. Then the U.S. FDA has issued a study may proceed letter regarding the protocol for the Janssen-led phase II study for patients with Stage III non-small cell lung cancer. Fifth, we begin elaboration of the overall clinical development plan for NBTXR3, including new indication beyond head and neck cancer and non-small cell lung cancer. And lastly, Janssen consolidated global development and commercialization rights via the assignment to Janssen of the licensing agreement relating to China and other Asian markets and territories from our former Nanobiotix partner, LianBio. As you have heard, we've made significant progress with Janssen advancing NBTXR3. It is key to understand that bringing a therapeutic candidate from concept to global registration is an exciting, yet daunting proposition for any development stage biotechnology company, even those working within well-known asset classes with well-established development and regulatory pathways. That is why we believe that our global licensing agreement with Janssen was, and continues to be, the right move for the patient, for healthcare professional, and for all the supporters of NBTXR3's potential. We are confident that the leadership of the Joint Strategy Committee will optimize the probability of success for NANORAY-312. Importantly, our global licensing agreement with Janssen also includes plans to further evolve the NBTXR3 development pipeline. These plans include an established framework for potential complementary co-development of relevant indication in the near, medium, and long term. The Joint Strategy Committee will recommend the next indication beyond the immediate operation priorities in head and neck and non-small cell lung cancer. Our current pipeline, beyond Stage III lung and locally advanced head and neck cancer, has already shown the expansive potential of NBTXR3 and continues to progress. In our IO combination program, NBTXR3, in combination with anti-PD-1 therapies for patients with recurrent or metastatic head and neck cancer that is naive or resistant to anti-PD-1 treatment, with and without metastasis, is being explored in two cohorts in Study 1100. An ongoing Nanobiotix-led phase I clinical trial that has completed dose escalation and is in ongoing dose expansion. We expect to present initial data from the head and neck cancer trial expansion cohort at ASCO this June. The third cohort of this study, including patients with metastasis for multiple primary cancer, will be presented later in 2025. Expansion opportunity in additional cancer setting in the medium to long term are being investigated in several trials that are part of our ongoing collaboration with MD Anderson Cancer Center in Texas. This includes phase I studies that have completed dose escalation and are in ongoing dose expansion in locally advanced pancreatic cancer and inoperable recurrent lung cancer, and in an ongoing phase I study in dose escalation, evaluating NBTXR3 in combination with chemotherapy in patients with locally advanced esophageal cancer. We expect multiple readouts from this study in the next 12 months. Additionally, several Nanobiotix-led phase I study have been completed, with primary endpoints met in patients with hepatocellular carcinoma, with and without liver metastasis and in rectal cancer. Our main focus and priority for NBTXR3 program is validating the safety and efficacy of radiotherapy, activated NBTXR3, and moving to global registration in locally advanced head and neck cancer. This effort accounts for the majority of operational and financial resource allocation. Nanobiotix expect to lead a new phase I randomized study in a new indication in due time, once NANORAY-312 sponsorship transfer has been completed, additional funding has been secured, and approval has been confirmed by the Joint Strategy Committee. Now, let's turn to the promising future of Nanobiotix beyond NBTXR3. As the NBTXR3 program moves toward the ultimate goal of reaching millions of patients with cancer around the world through the execution of our study, both ongoing and planned, we are working to expand the impact of nanoparticle-based therapy in healthcare through continued early stage development of our nanoparticle expertise, which include two additional platforms, Curadigm and OOcuity. Like NBTXR3, this platform has been years in the making, and we are excited to share some of our progress with you today. Curadigm has produced a Nanoprimer, has its first product candidate, which is designed with specific physical chemical properties to allow its nanoparticle to transiently occupy liver cell responsible for therapeutic clearance. This allows a subsequently delivered therapeutic to bypass the liver's clearance mechanism. This is intended to increase bioavailability and subsequent accumulation of therapeutic in targeted tissue, thus allowing the medicine to do its work. This has the potential to see increases in the efficacy or decreases in the toxicity, or reduction in the needed dose of subsequently administered medicine. The OOcuity platform is based on the principle that nanoparticle materials can interact with and influence neuronal networks via their electrical properties. The goal is to potentially enable modulation of malfunctioning neuronal network toward a normal state. In particular, the reduction of neuronal hyperexcitability associated with neuropathic pain has been observed in both in vitro and mouse model with several nanoparticle candidates. We expect to provide an expert base on plan and operation progress for our Curadigm platform in the second half of 2024. As you heard today, we've made significant strategic and operational progress in our NBTXR3 global alliance with Janssen. This include the intended sponsorship transfer of the pivotal NANORAY-312 trial, modification of the NANORAY-312 to optimize the regulatory pathway, and continued ongoing exploration of expansion opportunities for NBTXR3 in other indications. These achievements validate the potential of our nanoparticle platform and strongly position us to expand our Nanobiotix corporate strategy. We plan to allocate some of the expected profits from NBTXR3 to further develop our Curadigm Nanoprimer nanoparticle platform to foster and enhance long-term growth, potential, and value of Nanobiotix. We look forward to providing you updates along the way. With that, I will now ask the operator to begin the Q&A session. Operator? Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A roster. We will now take the first question. Coming from the line of Jonathan Chang from Leerink Partners, please go ahead. Hi, guys. Thanks for taking the questions. First question, can you discuss how you're thinking about strategies to extend the company's cash runway? And then second question, can you provide any color on the alignment process with J&J, on a global development plan for NBTXR3, and when we might hear more on the potential medium to long-term opportunities? Thank you. Thanks, Jonathan. So maybe let's answer the question number 2 before going to question number 1. So and, and maybe before, let's give some context in this shift in sponsorship. I think when we, if we put ourself 1 year ago, the focus of the company was about getting the 31 2 to the interim readout as fast as possible, and that was the context in which we've been operating. Then last July, we've been signing this deal, and the whole idea of this deal being to, with our new partner, making sure that we can reach the largest number of patients possible, and to grow the pie and to grow the market, if I may say. So we've been shifting from having all focus on getting this interim readout as fast as possible, to a focus which is enlarging the number of indication, like adding the lung cancer, which is, again, a bigger market than head and neck, but also to go in a more secure or de-risk way. So that's why, along and around all this, discussion we have had on what's the best timing to transfer the sponsorship, we ended up in this decision. So there have been some internal, discussion, of course, at our partner level. Then there have been an agreement at the GSC, and then an endorsement by our board. So that have been the process to get, to this decision. And, and I think that there's a, there's a big, question about why now versus later. First of all, in order to for J&J, to be able to register the product, to start pre-market activity, and to launch the product effectively, they need to be sponsor of this trial. There was a choice to do it either now or after the interim readout. Given the work and the heavy lifting that represents such a transfer for a global trial with 500 patients, that will take months and months to get there effectively. We thought the best thing to do is to do it now, take the burden now, and don't have this burden post-interim readout. After the interim readout, assuming the data are positive, we can be fully focused on, and J&J, could be fully focused on registering the product and starting all market activities. So that's the context in which we, we operate, and we've been, of course, doing this press release. Now, as you mentioned, this is opening a question about the current cash runway and financing, but maybe I'll let Bart answer that question. Thank you, Laurent. Thank you, Jonathan, for the question. Yeah, just to recap, you know, we believe that it's an important step forward in de-risking of the asset, positioning it for success, and really optimizing its potential for the benefit of patients and HCPs. As we indicated in the press release, the cash runway is unchanged, and yes, it implies that we need to finance through the updated timeline that we communicated. That said, we have, you know, much data to deliver between now and mid of 2025 for the milestones that we shared in the PR. And based on prior study results, you know, we look forward with conviction to sharing those updates. And you know, as any other biotech, we have multiple options, and we're very confident that we will work through this. As you may appreciate, we cannot comment on either the timing or the composition or sizing of the milestones. Understood. Thanks for taking my questions. Thank you. Thank you. We will now take the next question from the line of Lucy Codrington from Jefferies. Please go ahead. Hi there. Thanks for taking my questions. So just again, sorry, the transfer of the sponsorship, just in terms of what does the timing look like for that whole process? It sounds like you do expect it to be done before the interim readout in the first half of 2026. But I guess once that sponsorship is transferred, does J&J then take over financing of that trial, and therefore that alone could help extend your cash runway, where it happens sooner rather than later? Secondly, just your level of confidence in completing recruitment by first half 2026, and therefore the potential timing of that interim. And is there a minimum time after the completion of recruitment, at which point that interim would need to take place? And then just in terms of the funding for the new indications that you might take into phase II, I guess that's on top of your commitment to running, funding 312, or if J&J, were to take over 312, that, that might free up some funds. Thank you. Thank you, Lucy. So first of all, the expected timing for the transfer of the three twelve. So we're early in the process, the intent has just been agreed in the past few days. So it will take time, that's for sure, but the intention of course is to complete that way before the interim readout. That's the whole intention of making this transfer now. Now, in terms of obviously, this will add some investment on the partner side. Now we are just establishing what's the joint plan, not only to transfer the trial, but to continue to run the trial up to the end. Knowing that there will be no interruption of the trial during the transfer, that's the whole game we're trying to achieve here. So for the financing part, and how much this will cost to Nano, how much will cost to our partner, we can't talk for our partner. But on our side, we think for now it's neutral, may look at it in the future to be a bit positive, but we can't say more right now because we're, as I said, early in the process. So now to your second question about H1 2026 to get the end of recruitment, I think that's a good estimate. That we could qualify as a biotech, as a conservative estimate, but we think given the experience of recruitment we have had so far, plus what we expect to improve the recruitment with the involvement of a partner, we should be able to reach this target. That's within the realm of high possibility. So now, you asked a question about how the interim will play versus the last patient in and timing for that. So we expect, of course, to get the 283 events before, of course, the end of recruitment. And there's plenty of work that could be done prior to trigger the interim per se. So talking theoretically, here, because we, again, can't talk for our partner, the idea is will be to be ready, to just push the button and to have almost concomitant, last patient in and, the interim, readout for, for the trial. So, your third question, if I recall correctly, was about new indication and how, we select and, move forward in that direction, and what about the, the finance? First of all, I think that overall in our plan, including the transfer of the 312, there's still a lot of work to be done here. So we don't expect to have opening bandwidth, from the team, within the period of the transfer, because we'll be heavily working on that, versus what we're doing, today already. But the new indication, I think we have a large pipeline today, showing all the possibility or at least a big part of the possibilities of NBTXR3. And based on that and some other consideration, we will define what could be a new indication for Nanobiotix. And the goal here being, when we start freeing up some bandwidth of the team, when the transfer is complete, then we could start thinking about adding a new trial. And this will, of course, depend on potential additional funding and, and at a later stage, when the milestone payment coming from also the, the contract we have with, with J&J. So, we'll keep you updated on that, obviously, and over time, we can start building all the next opportunity we have for NBTXR3, but also, as we mentioned in the PR, beyond NBTXR3. Thank you. Thank you. We will now take the next question, coming from the line of Suzanne van Voorthuizen from Van Lanschot Kempen. Please go ahead. Hello, this is Chiara Montironi. I'm on behalf of Suzanne. Thanks a lot for taking my question. I have two questions, if possible. The first one will be, can you provide some color on, how imminent will be the phase II in lung cancer? And if it's not imminent, which are the gatekeeping items here? The second question is more about the new programs, the new platform, Curadigm and OOcuity. Which kind of updates should we expect in H2 2024? How concrete is that? Are you already working on some product candidates? Thank you. Thank you. So about lung cancer, which is the randomized phase II trial that J&J, is going to run. We've been publishing recently a good update explaining that FDA got the green line or get the green light about the protocol design, and obviously that's going to trigger a number of activities and work around that by our partner. So we can't say more at that stage, but as time always counts in what we do, then you can imagine that everyone is working heavily to get that done and started as soon as possible. I think we'll be able to give some update over time in agreement with our partner about the development of this clinical trial. Now, for the question on Curadigm, the expected update we want to give in H2 is about how we're gonna build the strategy and the business model around this new platform, which could give not only one product, but multiple product, and in any case, multiple applications in different therapeutic area. So as I think I have mentioned in the past few calls, that's a technology that offers many, many opportunities. And some of the key thing and key question we would like to answer and discuss with you in H2, is how we're going to build a sustainable business model with the whole different possibility we have with this type of technology, both on internal development and of course, external collaboration and business development activities. Now, to your question, do we have already a lead in this technology? Yes, we have multiple products that could be used to continue to develop this platform. But obviously, we will give you much more on this in H2. Okay. Thank you very much. Thank you. Thank you. We will now take the next question from the line of Swayampakula Ramakanth from H.C. Wainwright. Please go ahead. Thank you. This is RK from HCW, right? Good afternoon, Laurent. Just on the long term, thinking about Curadigm and OOcuity, so you have certainly generated a lot of validation on your NBTXR3 program, and, you know, how much of that validation can be transferred into these two new nanoparticle platforms? The reason for that question is, can you point to NBTXR3 if a partner comes in and wants to talk about either Curadigm or OOcuity, is that enough or you need to generate data only with that, with that sort of data, would the partner actually sit at the table? Thank you, RK. That's a good question. Maybe just before I answer this question, just want to reiterate that on NBTXR3, we still have a lot of work to do, and there is a lot of untapped value for this first product within the collaboration we have, and the primary focus of this collaboration being and the company, being to make that work. And also to get the value of this product and collaboration recognized in the value of the company. Now, we're starting building the future, as we've been discussing that. And in terms of Curadigm, of OOcuity, there is a broader validation that our product is bringing, is the introduction of nanophysics-based manufacturing into the healthcare. Now, as all products are different and have different, therapeutic applications, of course, we need to generate a number of data, to, to get to a potential partnership and so on. The main difference being that for both platform, OOcuity and Curadigm, we are talking here about a wide technology platform, where we can not only work with products and co-develop or license product, but we could also start licensing part of the technology to partners for them to develop their own product. So again, there's multiple, opportunities here, from very short term to medium and long term, and that's what we intend to, to be able to explain to you, in the second part of this year. So, should we expect some sort of a preclinical data from both Curadigm and OOcuity, if not in the second half, but over the next, say, 12 months? You know, trying to do this parallel track or I'm just trying to understand how you would be developing all three programs, albeit at, you know, at different levels of development, of course. Yes. Without giving you any precise date for second half, yes, we'll be able to show all this. Perfect. Thank you. Thank you very much. Thank you, RK. Thank you. There are no further questions. I will now turn the call over to Dr. Lévy for his closing remarks. Thank you. And maybe before I make some closing remarks, just want to remind the audience that we have been publishing that we will present at ASCO our data on the immuno-oncology program with our lead product, NBTXR3. And we think this data and this specific application of NBTXR3 is very important in regards to opening new doors and also potential new indication for Nanobiotix. So, I hope to see you at that call when we will disclose and explain and discuss the data. And on that note, I'm going to thank you and wish you a very good day and rest of the week, and let's stay tuned for the next piece of news that will come in the coming few days. Thank you very much. Have a great day. Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.