Good day, and thank you for standing by. Welcome to the Nanobiotix business update and full-year 2022 financial results conference call. A slide presentation accompanying this call can be found at the Investors section of the company's website at www.nanobiotix.com. [Operator Instructions] 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, operator. Good afternoon, and good morning. And welcome to the Nanobiotix conference call to discuss our full-year 2022 financial and operating results. Joining me on the call today are Laurent Levy, Co-Founder and Chief Executive Officer; and Bart Van Rhijn, Chief Financial Officer. 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 the SEC in the United States, including the URD and 20-F filed yesterday, both of which are available in the Investor Relations section of our website, along with the press release issued yesterday, highlighting our corporate and financial results for the period. 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. With that said, I'd like to turn the call over to Laurent. Please go ahead.

Thank you, Craig. I would like to welcome everyone participating via conference call and webcast today. I would also like to welcome Craig to his first Nanobiotix conference call as he recently joined us as our new Head of IR. If you haven't already met him, I'm sure there will be opportunity to do so soon. As Craig mentioned, we issued a press release yesterday highlighting the company's full year's operating activity and financial results for 2022. For today's call, I would like to begin by providing an overview of our accomplishments and review upcoming milestones for each of our program before turning the call over to Bart to address financials results, after, we will open the call for your questions. Each year, since initiating development of our lead candidate NBTXR3, we have seen evidence continue to mount suggesting NBTXR3 has the potential to change the way solid tumors are treated and improve outcomes for patients. This past year, not only we saw this trend continue but also provided an opportunity to showcase the strength and agility of Nanobiotix's team and its partner, along with the commitment and support of our investigator, researcher, and most importantly, patient, who have continued to support our efforts. Against the backdrop of geopolitical unrest, the ongoing pandemic, and continued volatility in the capital market, the team remained focused on our mission and adapted to circumstances to successfully first initiate NANORAY-312, our global Phase 3 trial in head and neck cancer in the US, Asia, and Europe, complete enrollment in Study 102, also in head and neck, generate new compelling data from our IO combination program, and early, but very encouraging data on pancreatic cancer, and significantly reduce our operating expenses, secure future access to capital through an equity line, and restructure of debt obligations.…

Thank you, Laurent. As Laurent mentioned, the enrollment of our first patient in in NANORAY-312 provides an exciting start to 2022, and our commitment to advancing this study remains our priority, defining how we navigated the remainder of the year. As the broader economic pressure and market volatility persisted, we took quick action early in the second quarter to significantly expand our cost control efforts initiated in 2021 by prioritizing investments in NANORAY-312 and Study 1100, scaling back preclinical programs and optimizing manufacturing and infrastructure expense to ensure we are well positioned to execute our core programs. The results of these efforts to enhance operational efficiencies and improve our cost bases across all our programs are evident in the financial results we reported yesterday, where we see only the most increase in R&D expense of approximately EUR2 million compared to 2021, despite the initiation of our pivotal Phase 3 registration study, the continuation of Study 102, and our ongoing immunotherapy in combination Study 1100. Likewise, you will note SG&A expenses decreased by EUR1.6 million, or 8.1%, from EUR19.4 million for the year ended December 31, 2021 to EUR17.9 million for the year ended December 31, 2022, reflecting our efforts to rationalize SG&A expenses and internalize key functions. While the company did not generate revenue in 2022, we successfully expanded eligible expenses and increased our overall research tax credits, as a result, by more than 60% year over year, and a portion of this gain represents a recurring increase to this credit. As a result, our total income increased significantly to EUR4.8 million for the year ended December 31, 2022, compared to EUR2.6 million for the year ended December 31, 2021. To further improve our financial flexibility and extend our operating runway, we've successfully restructured EUR30.7 million in outstanding debt with…

Thank you, Bart. In 2022, we continued our prioritized focus on further advancing NBTXR3 treatment of head and neck cancer. To date, the totality of clinical data continues to support the potential of our product to offer a meaningful therapeutic benefit to a large number of patients in oncology. Our initial focus in head and neck cancer is establishing a framework that can be expanded and replicated across other solid tumors and, as a reminder, we know that around 60% of all cancer patients who receive radiation therapy. With the recent strengthening of operation and executive leadership, we believe we are well positioned to execute across our near-term catalysts through the year. Looking ahead, '23 will be a foundational year for several reasons, and including different milestones and clinical data that we should expect. On our primary focus, head and neck cancer, we will have the final data coming from the Phase 1/2 Study 102, also an update on the 1100, and we continue and we will continue to progress in the pivotal trial NANORAY-312 to prepare, as planned, the interim readout for H2 '24. In addition to our priority focus, head and neck, we will get the first data coming from our last collaboration with MD Anderson, including pancreatic cancer and lung cancer trial results. With that, I will now have the operator to begin our Q&A session. Operator?

[Operator Instructions] Jonathan Miller, Evercore ISI.

Hey, guys. Thanks for taking my question. Let's start with the head and neck studies. I'd love if you could give us some more color on the protocol amendment you're talking about for 312 that might increase enrollment rates. And relatedly, I noticed you're sticking to guidance for data in the second half of '24. You also alluded to the possibility that there's an acceleration possible there based on Study 102 readout. Can you talk about the pushes and pulls there, and how much this could impact timeline to the 312 readout?

Thank you, Jonathan, for the question. So head and neck study pivotal trial, as you know, is a randomized Phase 3 study that is run globally, US, Asia, and Europe. And here, that's a 500-patient trial, randomized one to one, where early on, via our partner, will treat 100 patients out of the 500 total. So to date, what we've been seeing is after a slow start of this trial, as expected in such a complex time with the war in Ukraine and the end of the COVID period, we're seeing a good ramping up of the patient recruitment right now and have been able, across the year, to get much more sites activated and also open new countries that were not initially planned in order to compensate the loss of Ukraine and Russia and also the slow start of the trial. In addition to that, we looked at real world and discuss with our investigator in this trial to look at how can we ease the patient recruitment in this trial. So we've been doing some minor amendments in order to facilitate the number of patients that could have access to this trial. And that includes, but not limited to, some better or easier definition of what will be the eligibility to cisplatin in order to include more patients. We also have included a bit more patients in term of T&M definition and had been the previous background and record data from the patient entering the trial. So all this, we think, will help to accelerate the recruitment rate. And just of note, to date, we have only a part of the final number of sites that we expect that are currently recruiting. There's two sites happening. So we expect two things that make us think that we'll have…

Okay. Makes sense. One more for me. I would love to hear more about your runway assumptions. I understand the updated runway doesn't include the equity line or other sources of capital and is making conservative assumptions about these debt covenants. What would the runway be if you did include all of your anticipated, not additional BD, but already negotiated equity lines, full access to the debt, and no covenants? What would the less conservative runway look like?

Thank you, Jon, for the question. This is Bart on the line. That would not have changed in what we have guided to previously, which would be Q1 of '24.

Okay. Thank you very much.

Elliott Bosco, UBS.

Hi, everyone. Elliott Bosco on for Colin Bristow from UBS. Another one on NANORAY-312 recruitment, could you elaborate a little bit more on some of the regulatory challenges you're facing? And additionally, could you speak to the amount of sites that needed to be replaced or incrementally added through some of the challenges. And then last question, could you provide additional commentary on your strategy for potential collaborations or partnerships? Thank you.

Thank you. So in terms of the regulatory challenge, I think, in Europe, as we know, our product has a medical device status. And for most of the rest of the world, it is a drug. And as there is a fundamental reshaping in the medical device status in Europe and regulation around that, we went through some hurdle in order to connect our old regulatory system versus new regulatory system in Europe. So we went through a number of interaction with agencies in order to connect the dots and to be able to start the trial. So this has been causing some delays, which did not happen in other countries. In Asia, we've seen some lockdowns due to the COVID no later than end of last year, and beginning of this year was still the case that now it's real. And for US, that meant other was about the COVID tail, where it has slowed down most of the activities in hospitals. We think, now, everything is back to normal, and we're progressing well on every front. Now, in terms of replacing the sites that have been closed in Ukraine and Russia beginning of last year, we've been opening more sites in other countries that were already opened, like France and Spain and others, but also have added two or three other countries in order to compensate that. So the idea here was to make sure that by adding those sites in existing or new countries will recompensate the exclusion of Russia and Ukraine at the beginning and the little start that's a little slow versus what's expected. But the good thing is now, we see a very good ramp up in terms of recruitment and all base statistician. With the real-word life recruitment rate that we see today and the ramp up we see inside exploration, we maintain our guidance to get the interim readout second half of '24. And sorry, what was the last part of the question? Yes, partnership, right?

Yes. Your strategy to partnerships, collaborations. Thank you.

Okay. So just maybe a piece of context. I think we all see how the market is for the past 18 months, two years, and even a bit more. So in an efficient market, it will make sense and would that make sense to raise more money in order to pass the interim readout in order to create more value. And after that step, maybe establishing some partnership and collaboration with industry. Now, as we all see the market is not what we would hold high as expected to be, so we changed our strategy in the recent past. And we see like collaboration or industrial partnership as a key option for Nano in order to move forward and guarantee that we can reach a lot of patients and also guaranteeing the value for shareholders.

Thank you. That's all for me.

RK, H.C. Wainwright.

Thank you. Good morning, Laurent and Bart. Just a couple of quick questions. Just trying to find out if there's going to be any clinical data presentations at ASCO coming up. And also, when MD Anderson releases data on pancreatic cancer later this year, how are you thinking about taking this indication forward, expecting this data to be positive from here?

Thank you for the question. So yes, we expect at ASCO and other conferences for the second part of the year to present new data with our program. We will disclose in due time at which conference obviously we will present different data we have. But as you mentioned briefly, we expect to present the final data of the 102 study and also some other data coming from this study and update on the 1100 and the trial coming from MD Anderson. And as far as MD Anderson is concerned, we wait to get the lung cancer trial first results, but also pancreatic cancer trial data. I think that, as we mentioned, a very interesting trial because we think here, we could have a big impact for the patient. And what we should look at when the data coming out is the population we are treating here. We're talking about locally advanced pancreatic cancer patients that are fully [inoperable]. And for those patients, usually there is not much of a therapeutic option. What we have been doing after this patient getting a round of chemo as the standard of care is what is proposed. We have been injecting NANORAY and then activate it by radiation and look at the outcome for the patient. So what will be important here is to see how much of this patient we can stabilize, how much potentially we could have response, which is rare in this population, even more rare is how many of these patients could get surgery coming from inoperable to operable. And so all those data will be presented. And then, for you to know, we also have started the expansion part of this trial that we expect to conclude before the end of the year. And based on all these data, we think we should be able to propose a next step for pancreatic cancer patients. Now, what's not yet decided is the format of this next step for the pivotal trial. Will it be something else? So that will be discussed a bit further, and I think we'll give an update on that when we present the data of this trial.

Thank you, Laurent. Thanks for taking my question.

Thank you, RK.

Clément Bassat, BNP Paribas. Clément Bassat: Hello. Thank you for taking my question. Just one about your relationship with the EIB. You advised that the EIB is willing to extend for six months their requirement of EUR15 million in a grant instead of EUR25 million, but the condition is to find a partner. And I have in mind your CE mark in the STS program, and did they request or strongly suggest you to start the commercial phase on this program in Europe? And finally, are you in touch with the potential partners to do that? Thank you.

Thanks for the question. I think the STS is an interesting and important question. As you know, we've been successful in running a Phase 3 randomized trial, proving the superiority of NBTXR3 over the standard of care in a very hard to treat patient population, which is locally advanced soft-tissue sarcoma patients. Now, we also obtained the CE mark for that a few or two years ago. And the idea here is to capitalize on the existing CE mark, so when we get the head and neck data and hopefully positive interim readout that we could submit an extension use of the NBTXR3 to go from STS to head and neck cancer patients. We will not start commercializing with soft-tissue sarcoma because that will be globally detrimental to the whole franchise of NBTXR3. And also, the effort we have to deploy to make this product commercially available across Europe will not be interesting versus starting first with head and neck and obtaining a potential good price, a fair price, for the product and then extend it to the soft-tissue sarcoma and then start selling both in head and neck and STS. Now, as far as EIB's concerned on this topic, their fully backed strategy on this has potential ongoing discussion we have, talking about STS and the strategy to start with head and neck. It's seen by all our potential and existing collaborators as the right time to move forward. Clément Bassat: All right. Thank you.

Thank you.

Thank you. There are no further questions at this time. I would now like to hand the call back over to management for any closing comments.

Thank you. So I will just would like to thank you all for participating to this call, and we look forward to further executing across our upcoming milestones. And we'll continue, of course, to keep you updated on our progress and our fully and obviously much more clinical data that will come this year. Thank you very much, and I wish you all a very good day.

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.