Good day, and thank you for standing by. Welcome to the Nanobiotix Business Update and First Half 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a Q&A session. Please be advised that today's conference is being recorded. At this point, I’d like to 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 first half 2023 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 SEC in the United States, including the RFS and 6-K 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. As Greg mentioned, we issued a press release yesterday highlighting the company's first half 2023 operating activities and financial results. For today's call, I will begin with an overview of our accomplishments and review upcoming milestones for each of our program. Bart, our Chief Financial Officer will follow up with financial updates. I will then give closing remarks before opening the call for questions. The first half of this year has been truly transformative for Nanobiotix, following the successful completion of a global license agreement with Janssen, the appointment of Dr. Kayitalire, an industry-veteran in oncology as Chief Medical Officer, and the ongoing advancement of trial designed to establish the clinical foundation of NBTXR3 in multiple solid tumor indication. I'm very proud of what the company has accomplished in the past months. Collectively, this achievement continues to propel late-stage development of NBTXR3 forward, expand our patient reach, and ultimately position us to realize the paradigm changing potential of NBTXR3 worldwide. We're very excited about the recent global licensing co-development and commercialization agreement with Janssen Pharmaceutica. One of the Janssen Pharmaceutical Company of Johnson & Johnson for NBTXR3 or potential first-in-class radioenhancer. This partnership is designed to leverage the strength of both companies and accelerate and broaden the treatment potential of NBTXR3. As part of the agreement, the initial focus of clinical development will be on the head and neck and lung cancers, with expansion potential in additional solid tumor indication. We believe this partnership underscores the therapeutic and market opportunities of NBTXR3 and importantly, further validate our platform and our scientific approach. What we find particularly attractive about this deal is that it offers both near-term and long-term value for shareholder, including access to…

Thank you Laurent. Good morning and good afternoon, everyone. As Laurent mentioned, we are pleased at our agreement with Janssen provides Nanobiotix with substantial near and long-term value. I will start with a brief overview of the key elements of the deal. The company already received the $30 million upfront cash licensing fee and is eligible to receive $30 million in-kind regulatory and development support for study NANORAY-312 provided at Janssen's sole discretion, and $30 million in equity in two tranches of $5 million and $25 million that are subject to certain conditions, and in the case of the $25 million, a future qualified financing of at least $50 million in the aggregate. We are pleased to have already received the first equity charge of $5 million following shareholder approval and issuance of approximately 960,000 shares for a subscription by Johnson & Johnson Innovation, representing a stake of 2.65% in the company. As part of the long-term value, the company is eligible for success-based payments of up to $1.8 billion and tiered double-digit royalties on net sales of NBTXR3. Additional success-based potential development and regulatory milestone payments of up to $650 million are also available in the aggregate for five new indications that may be developed by Janssen at its sole discretion. For indications developed by Nanobiotix in alignment with Janssen, the company has potential to receive up to $220 million in aggregate for indication. Now we transition to the financials. Revenue and other income increased for the six months ended June 30, 2023 at EUR3.3 million compared to EUR1.3 million for the six months ended June 30, 2022. The company has mainly benefited from the research tax credit granted by the French Government to encourage companies to conduct technical and scientific research, and from the supply and collaboration agreement…

Thank you, Bart. As you can see, we have an exciting 12-24 months ahead of us with multiple value creating catalysts across indication. A new Chief Medical Officer to help execute across our clinical program and a new partnership with Janssen that provide both near-term and long-term value and robust developmental and commercial capabilities. Collectively, these achievements are all designed to help support successfully execution of our mission to bring NBTXR3 to as many patients as we can worldwide. In the coming weeks, we look forward to reporting final Phase 1 data in head and neck cancer and initial Phase 1 dose escalation data in pancreatic cancer for NBTXR3. During 2024, we also expect to report data from NDA (ph) sponsor trial in esophageal cancer. And finally, in the second half of next year, we look forward to the interim results for our NANORAY-312 Phase 3 trial in head and neck cancer. With that, I will now have the operator to begin our Q&A session. Operator?

Thank you. We'll now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from Lucy Codrington with Jefferies. Please proceed with your questions.

Hi, there. Thank you for taking my questions. Just ahead of the pancreatic cancer data in the coming weeks, just wondering, if you could kind of outline what we should be expecting from that? Is it just a safety update or will it also include initial efficacy measures? Then secondly, in terms of the payment in kind support for 312, when can we expect that to begin from J&J? I appreciate it. It is at their discretion, but any potential guidance on that? And then finally, in terms of the IO combination, Phase 3 and beyond, just whether you can give us any insights into J&J's commitment to that. I noticed that they have authority over all regulatory matters. Does that include the interactions regarding the Phase 3 and is this still something we can expect as a near-term catalyst? Thank you.

Thank you, Lucy. So let's tackle maybe the first question about pancreatic cancer. So as you may remember, this is within the large alliance we have with MD Anderson that will encompass a number of clinical trials and where the moment size are ongoing. One of these trials is Phase 1 that includes escalation and expansion part on pancreatic cancer patients. So what we should expect in the next few weeks is about the data coming from the escalation and the first patients coming from the expansion. And this will be about safety and feasibility, of course, as you mentioned, but we will also start looking at the first sign of efficacy. Just as a reminder, in this first part of the clinical trial, we have been treating locally admins, pancreatic cancer patients. So the one that have a tumor that is not operable, and usually what you try to do with this patient is to give them some induction chemo followed sometime by radiation plus chemo, and unfortunately because of the type of disease then those patients they have a very short life expectancy and not many of them will respond to the treatment. So I think what will be very important to look at here outside safety and feasibility is also what is the first thing, we can see in term of disease control rate, in term of survival, what's part emerging from this trial. And of course, as I mentioned, the expansion part is ongoing, so we'll be happy to continue to communicate on this trial. So I think that's for the question one. The second question, if I remember, well, Lucy was about the contribution in kind from J&J in the 312 trial, which is our ongoing global Phase 3 on locally advanced head and neck…

Thank you.

I hope it has been a helpful answer to your question.

Our next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please proceed with your questions.

Thank you. Good morning, Laurent. On the data, we are expecting some final data from Study 102 in the coming weeks, you said. Just trying to see what sort of a read through can we get from that to the NANORAY-312.

Thanks, Ramakanth (ph). So as you mentioned and we did mention in the PR again in coming few weeks, where we're going to have an update on the 102 data, which will be about the final readout of this trial. I think this readout is very important, because that's the last one we have on the primary end point of this trial that should, include inform us on the potential success of the 312 or ongoing Phase 3 trial. I think what we should look at carefully here, of course, safety is always a must have in such a population which is frail elderly and that can't receive many treatment. But on the top of that is the final readout of the efficacy, that will include the rate of response, the complete response, the duration of response, which is critical and also the PFS and the OS when the data have matured. You may remember that we have been given to the market some information on going basis with this trial, but the data were not that mature and now we have the full set of data with long-term follow-up for patients, so we'll get that there very soon. So just to put that into perspective versus the ongoing Phase 3 trial, you may remember that in the Phase 1, we have a very frail population with very high comorbidities and in this population, we have injected the primary tumor and irradiated the primary tumor and have been looking at the impact of this for the patient. When I talk about the primary tumor is that a good number of those patients also have lymph invasion and for this lymph nodes we just have given a radiation to rapid dose, no NBTXR3. So that's a difference, which is fundamental or could be very important with the ongoing Phase 3, where we inject not only the primary but also potentially some of the lymph node that are surrounding. So what it does tell us is, when we look at the data from the 102, we may expect additional efficacy in the 312 also. But let's see and let's wait when the data are coming and have a full review on what it means for patients and what is the impact we could expect for the 312.

Thank you for that. One more question. On the non-small cell lung cancer data that MD Anderson is going to release, is your partner, Janssen going to wait for that data before they decide on their study in terms of design and whatnot or are these two independent events?

Thanks for the question. And I think that's an important precision, so thanks for asking. These are two independent pathways, right? At MD Anderson, we are treating here a very specific population in non-small lung cancer. We're talking about patients that already receive radiation for the local treatment of the disease and have a local relapse. So here, we tried to inject the product post-relapse and tried to make a re-radiation with a smaller dose of radiation in a pre-radiated area. So the good thing is that we did not hear about this trial in that term, so it means that so far the safety is good, and that's a very good surrogate to see that we can inject in lung even in very specific and hard condition of the pre-irradiated tissue. So that's the MD Anderson pathway, and we expect to conclude the RP2D very soon, and to be able to communicate the first data after that. As far as the J&J cancer program is concerned, here we will talk more about naive patients, pre-treated, not pre-treatment, sorry. And as we mentioned in our PR, we're looking at Stage 3 lung cancer patients. So the scheme of treatment and the patients are different. So at maximum, we could get inspired by the safety of what we see at MD Anderson, but the program itself will be started and will be launched separately.

Thank you. Thank you, Laurent, for taking all the questions.

You're welcome.

Thank you. [Operator Instructions] Our next question is from the line of [indiscernible]. Please proceed with your question.

Yes. Hi. I had a question with -- Can you hear me?

Yes, we can.

Yeah. Sorry. I had a question regarding Hensify in soft tissue sarcoma. Was it discussed with J&J? Do they plan to launch it after the launch of the first product in head and neck? And the second question was regarding LianBio and their commitment to five registrational trials. Have they mentioned any interest beyond the LA (ph) head and neck program? Thank you.

Thanks, [indiscernible]. So let's start maybe with soft tissue sarcoma. As you may know, around the table, we already have had a positive Phase 3 randomized trial in soft tissue sarcoma patients that led us to get an approval on the European market. So obviously there has been part of the extensive due diligence that J&J have been doing on the product and part of the discussion we have and as soon as we're going to start like operations and discussion around the commercial aspect of the product and how we're going to do it in which order starting with which country and then this will come back obviously on the table. But for now, we have no specific story to give on this aspect. But the promise will keep you posted on what's going to happen for this product in this underserved population. For the second question about LianBio, you're right to mention that in the contract we've been signing with them, there is a commitment from them to be at least participating to five registrational trials in the context. And they do participate to the ongoing Phase 3 in head and neck cancer where they have the commitment to recruit 20% of the patient out of the 500 we have and the recruitment there is progressing well. Now for other indication, especially because the arrival of J&J in the game and now we have two other partners with Nanobiotix developing this product. So we are currently discussing beyond what is on the table and see what could be the next steps, but we have ongoing discussions specifically with the LianBio also to think about different options and different therapeutic activities we could benefit from in specific populations that exist in Asia. I would not mention which cancer, but there are many that will be a specific problem of this -- part of the globe that we're trying to tackle.

All right, thank you very much.

You're welcome.

Thank you. There are no further questions. I'll now turn the call over to Dr. Levy for his closing remarks.

So Ron, thank you very much for participating to this call. I see there are more people than usual. We are happy about that. We'll be very happy to communicate very soon with you about the next set of data that are coming, so pancreatic cancer and head and neck Phase 1 final data. And I think we'll take this occasion to look about how the future is coming and also what will be the potential outcome of the Phase 3 based on all this. So again, happy to have you all on board. Thank you for your help and let's talk soon.

Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.