Good day, and thank you for standing by. Welcome to the Nanobiotix Business Update and Third Quarter 2023 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. 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 third quarter 2023 financial and operating results and the clinical data presented at this year's ESMO conference. 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. Moving on to Slide number 2, 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, 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'll propose to start with Slide number 3. As you may have seen in our press release, you could see that we have had a very productive and busy quarter that we think is going to drive Nanobiotix into a great future. We've started this quarter by signing this $2.5 billion collaboration with Johnson & Johnson and gave a number of updates, including final data of our Head and Neck Phase 1 trial plus some exploratory data through ESMO and ASTRO that gave us some strength and some confidence about the potential outcome on the ongoing global Phase 3. On top of that, our partner, MD Anderson has been publishing data on pancreatic cancer showing a good feasibility and safety of this treatment for those specific patients, but also starting to see some strong signal of efficacy. As you will see, our recently completed financing round, we really strengthened our financial position, and Bart will give you an update on that. And we will finish this call by a Q&A session. Let's go now to Slide 4. Just to remind, for the new shareholder and the new people in this call, what is our first-in-class radioenhancer. Our product, NBTXR3, is here to combine with radiation therapy. And as a reminder, 60% of all cancer patients will get radiation therapy during the course of their treatment. How this product works? It has been designed to be a one-time injection directly into the tumor in order to maximize the concentration and the efficacy in the tumor and minimize systemic exposure for the patient. And this product is made of crystalline inorganic particle of a very particular material, hafnium dioxide. HfO2 is, first of all, a very stable inert material, which is good in terms of safety, but also provide…

Thank you, Laurent. Good morning and good afternoon, everyone. Nanobiotix has had an extremely productive quarter, and we believe that the company's position has been completely transformed into one where we have set the stage to allow us to deliver on the potential of NBTXR3, a pipeline-in-a-product. There's a lot of work left to do, but the company is on a substantially firmer ground than when we began this quarter. More specifically, we started the quarter with the bang as we began our collaboration with Johnson & Johnson through which we are working to bring NBTXR3 to the millions of patients that suffer from solid tumor malignancies that are amenable to treatment with radiotherapy. The first two indications targeted for development are planned to be head and neck cancers and lung cancers. But it is far from the full potential we see possible with the solid tumor and combination agnostic product like NBTXR3. And as you've just heard Laurent discuss, additional indications such as pancreatic cancer can, we believe, benefit from adding our potentially first-in-class radioenhancer to the treatment armamentarium. We believe the quarter has also seen the company address in a significant manner the financial overhang that has been an understandable concern of capital market participants. As of September 30, 2023, Nanobiotix had €37.8 million in cash and cash equivalents compared to €41.4 million as of December 31, 2022. For clarity, this cash balance does not take into account the €50.9 million financing the company just completed. We are grateful for the continued support we are receiving from existing shareholders and are pleased to welcome new shareholders to the journey. As previously disclosed, the European Investment Bank, or EIB, has agreed to the removal of the minimum cash and cash equivalent covenants from the company's EIB loan, effective October 13, 2023. As a result of the terms of this new agreement, the company will pay EIB approximately €0.5 million, which is 1% of the €50.9 million gross proceeds. Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of €37.8 million as of September 30, 2023 in conjunction with the €50.9 million on the recently completed financing, combined with the derisked milestone related to our NBTXR3 collaboration with Johnson & Johnson, results in a cash runway that extends into the second quarter of 2025. I would note that due to regulatory requirements, Johnson & Johnson's initial subscription to the second equity tranche was approximately €19.1 million. This amount is expected to be increased to the full €23.7 million or $25 million, following approval from the French Ministry of Economy to do so. If we include this last amount in our cash and cash equivalents projections, we expect that the cash runway extends to the end of Q2 2025. This run rate gets us into the timeframe in which we expect to potentially report the NANORAY-312 study interim efficacy results. And now, I will turn the call back to Laurent. Laurent?

Thank you, Bart. As you can see, we have had a very busy quarter that we think is going to help us to pivot Nanobiotix into a great future. With that, I will now ask the operator to begin our Q&A session. Operator?

Thank you. [Operator Instructions] Our first question comes from the line of Swayampakula Ramakanth of H.C. Wainwright. Please go ahead. Your line is open.

Thank you. This is RK from H.C. Wainwright. Good morning, Laurent and Bart. How are you do -- guys doing?

Hi, RK.

So, my first question is on the pancreatic cancer indication. So, certainly, it's interesting data that MD Anderson put out at ESMO. So, what do you think is the appetite for J&J to take this and go forward? And if they decide to do this, how soon do you think that those studies will get started?

Thanks, RK, for the question. So, we concur, I think what MD Anderson has provided as the first data in pancreatic cancer are very encouraging and interesting. As you know, that's an indication where it's very hard to provide something suitable for the patient. So, first of all, we think we should complete this trial, and the expansion phase is recruiting really well, and we should be able to finish that soon and to be able to report the final data on that. Now as far as the next step concern, I think there's a need for discussion, not only with J&J but also MD Anderson and LianBio to see, not only our pancreatic cancer should continue, but more broadly, how shall we expand the development of NBTXR3. Now -- for now, sorry, our focus is really on moving forward the head and neck program, but also starting the lung program that J&J wants to begin with. And as a follow-up and subsequent step, we will notify the market about the more global development plan about NBTXR3. For now, let's continue to push while it's on the table and promise in due time, we'll tell you about pancreatic cancer.

Thanks for that, Laurent. And then, MD Anderson is also conducting a few additional -- I mean, evaluating a few additional indications. Do you have an idea of the cadence of data that's expected from them?

Sure. So, you're right. MD Anderson is running different clinical trial, and we can name on the top of pancreatic cancer trial, the esophageal cancer trial or lung cancer. And as we also informed in one of the previous PR, they are preparing another big trial that hopefully will start soon, and we will tell you about it much more in the near future. As far as the new data are concerned, we expect to reach the RP2D in lung cancer soon and also all next year to start providing additional data on panc, on esophageal and on lung cancer too. So, we will -- we think across '24 and '25, keep informing you about how the progress are made with MD Anderson and give more data on all this. And as I mentioned in the previous question also, what are the potential subsequent step for a successful trial like pancreatic cancer.

Thank you. Our next question comes from the line of Colin Bristow at UBS. Please go ahead. Your line is open.

Hi. This is Yihan on for Colin. Congrats on the quarter, and thanks for taking our questions. So, I guess, I have two questions. So, the first one is just about NANORAY-312 statistical assumption. So, you expected the median PFS in the control arm will be around six months and the median OS will be around 12 months. Also, we think it is definitely like reasonable assumptions, but also note, the patients enrolled in this NANORAY-312 have a lower comorbidity burden versus the Study 102. So, just wondering if the control arm may perform relatively better versus the historical data. And what is your view on this? And the second question is about your runway -- cash runway. So, currently, you're assuming to second quarter 2025, assuming a development milestone. And you mentioned in your prepared remarks that it is derisked. So, I'm just like assuming there's no risk for this milestone. And just wondering if you think it is -- this will be sufficient to support the NANORAY-312 interim in mid-2025? Thank you so much.

Thanks for the question. So, in terms of hypothesis for the 312, I think the hypothesis that we have been taking are based on literature and what we've been observing in the recent trial treating elderly patients with radiation alone. And the hypothesis, as you mentioned, will be nine months for the PFS and the control arm in 12 months. And so, how do we read that versus the 102? First of all, the 312 will be positive if we get the tested arm with our product plus radiation to 13 months as the PFS instead of nine and 16 months for the OS, which is a lower burden than what we've been observing in the available population in the 102. So I think where we get some confidence is when you look at the real population, we've been treating in the 102. As we mentioned in the past, you have two-thirds of the patient in this population that have had high comorbidity. Whereas in general, you get more 20% to 30% max of the patient having this high comorbidity. So, being able to see such an improvement of such a PFS and OS in a population with such a high comorbidity, for us, is a very good sign of the efficacy of our product. Our hypothesis is if you get less patient with high comorbidity, meaning more patients that will have time to get the benefit of the treatment, we should be able to see even bigger or better results in the Phase 3. So, those are part of the hypothesis. And if we think that in overall, a larger population will perform better than the nine and 12 months, then our product should also perform better in a better population. So, that's why we think we have a good room to play in that regard for success of the 312 trial. Now, just to answer the other question you have, maybe about this, what we call the secured milestone or the de-risk milestone, that's a very short-term milestone we expect from this collaboration, which is due to the progress in recruitment in all Phase 3 head and neck cancer. And I will let Bart to comment on the cash runway versus the readout of the interim readout in the 312.

Thank you, Laurent, and thank you for the question. We're pleased to share with you that we removed the finance overhang that we did away with the EIB cash covenants and extended our runway into mid-'25. That includes that de-risk milestone, as Laurent indicated, that will be announced in the not-too-distant future. It's primarily a function of the timing at this stage. And as we shared in the press release, the execution of the last part of the second equity tranche that is subject to the French Ministry of Economic Affairs. So, we're excited about being able to focus on sharing updates with you and the markets with regards to what is coming over the next 12 months, and we're very pleased to be in this position.

Thank you so much. That's very helpful. Thank you.

Thank you. [Operator Instructions] And we've had one further question come through, that's from the line of Clemence Thiers at Stifel. Please go ahead. Your line is open.

Hi. Thank you for taking my question. I had one for the pancreatic cancer study. How comparable are the baseline characteristics of the patients into previous MD studies? And the patients in the ongoing Phase 1, for instance, in terms of level of CA19-9 at diagnosis? And could you give us the amplitude of reduction of that biomarker levels observed in your study? And my second question was on the EIB. If you could just give an update? Because you reimbursed the payment in time, you paid €0.5 million. In the old terms, it was either before June 2029 or two equal installments after commercialization. Now you have this new mechanism of royalties per amount of financing going on. Is it the only way you're going to reimburse the amount? Thank you.

Thank you for the question. So, about the MD Anderson trial in pancreatic cancer, so obviously, the baseline of the patients are both in all trial and the previously treated patients at MD Anderson, all locally advanced pancreatic cancer, so non-operable patient. So, it's not a real comparator, right? It's not a randomized trial. So that's why we've been taking every patient that have been locally advanced pancreatic cancer as a historical control versus the patient we've been treating. What is clear and interesting is what you mentioned about the CA19 comparison. So, in general, in this patient population, when you got high CA19 at baseline, it's a very bad prognosis. And there is a small amount of this patient at MD Anderson, for example, it was 17% of those patients that would have a normalization. And when you go for a patient getting normalization of CA19, usually have better outcome than the one that don't have this normalization. And in our case, with the 17 patients we've been treating so far, we got 42%. So, I think this is a very good first step to see that we have more patients getting to normalized CA19 with a good amplitude plus the OS that we start to see in this ongoing trial of 23 months. So, those two together are very good surrogate for us of efficacy of our product. Plus, the fact that in the comparator or the historical comparator data, most of the patients, they got radiation plus chemo versus what we got in our patient was radiation plus all products. So, there was less chemo or replaced by our product. So, we think altogether, that's a very good baseline to define what would be the next step in pancreatic cancer. And we're working on it right now, but we will inform you in a short -- in the near future about what we intend and plan to do in that regard. And maybe I'm going to give the mic to Bart about the EIB.

Thank you, Laurent. Thank you for your question, Clemence. So, with the EIB, you may remember that in 2022, we restructured the loan that introduced the milestone concept of €20 million. That would be repayable at the start of commercialization, but has a long stop date in mid of 2029. And what we shared with you today is that as part of the removal of the cash covenants, we included an ability for the EIB to get access to that €20 million milestone a little sooner. So, if there is a qualified fundraising, there is a tiered structure that allows them to get access to that. And based on the amounts we raised, that is 1% that resulted in that payable. But the overall loan restructuring that we did in 2022 really allowed us to essentially renew the loan at that stage to give the company a much more flexibility from a funding perspective, given the capital market dynamics we have been facing for the past three years in biotech. So hopefully, that addresses your question.

Yeah, very clear. If I just may a quick detail. I see that the RP2D in lung cancer of the MD study, it was initially supposed to be in H2 2023, has been moved to 2024. Why is the site delayed? Is there some enrollment decrease rate?

No, just to be on the safe side, in this trial, as you know, when we recruit patient, there is a three- to four-month delta between the injection of the patient and the potential readout of the end of safety study period to declare the RP2D. So, the enrollment continues to be good in this trial. It's just slightly delayed versus what was initially planned. But all the trial, I mean, you understand, globally are accelerating. The pancreatic is running well, esophageal, too, and they are preparing full speed this new trial that we will discuss soon with you.

All right. Thank you very much for answering.

Thank you.

Thank you. And as there are currently no further questions in the queue at this time, I'll hand the floor back to our speakers for the closing comments.

So, thank you very much, and thank you again to be so numerous in this quarterly call. We'll be happy to continue to report progresses of the company and a different program we have and hope to see you soon in-person. On that note, I wish you a great day and great rest of the week. Thank you very much.

Thank you. This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.