Nanobiotix - H2 2023

Transcript

Operator (participant)

Good day, and welcome to the Nanobiotix Business Update and Full Year 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 question and answer session. Please be advised that today's conference is being recorded. At this point, I will now turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotix. Please go ahead.

Craig West (SVP of Investor Relations)

Thank you. Good afternoon, good morning, and welcome to the Nanobiotix conference call to discuss our full year 2023 financial and operating results. Joining me on the call today are Laurent Lévy, 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, 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, I'd like to turn the call over to Laurent. Please go ahead.

Laurent Lévy (CEO)

Thank you, Craig, and thank you everyone for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company's full year of operating activity and financial results for 2023. For today's call, I would like to begin with an overview of our accomplishments and upcoming milestone before turning the call over to Bart to address the financial results. Then I will provide closing remarks before opening up the call for questions. 2023 was an incredible year of progress for Nanobiotix and our program on NBTXR3. Last summer, we entered into a $2.5 billion license agreement with Janssen Pharmaceutica, a Johnson & Johnson company, to expand the worldwide potential of NBTXR3, a potential first-in-class radioenhancer with universal application across solid tumor.

Late in 2023, our partner, LianBio, assigned its right to NBTXR3 in China and other Asian market to Janssen, thus consolidating global development and commercialization rights with Janssen, which is now responsible for the $205 million in milestone potentially available to us with this partnership. We also reported positive data from two key programs, including final and exploratory data from Study 102, our Phase 1 trial in head and neck cancer, as well as initial data from our Phase 1b study, supporting expansion potential in pancreatic cancer as part of an ongoing collaboration with MD Anderson. We will discuss this encouraging finding more in depth shortly. First, let's start with our global licensing for development and commercialization agreement with Janssen for NBTXR3. This partnership is designed to leverage the complementary strength of both companies, accelerating and broadening the treatment potential of NBTXR3.

As part of the agreement, the initial clinical development focus will be on head and neck and lung cancer, with expansion potential in additional solid tumor indications. We believe this agreement underscores the therapeutic and market opportunity of NBTXR3, and importantly, further validate our platform and scientific approach. We believe that this collaboration with our partner at the Interventional Oncology Group at J&J, has the potential to impact the lives of many patients. We believe this because NBTXR3 can treat patients at the stage of where their disease is local and do so 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 overall outcome for patients. As a reminder, or for those new to the story, NBTXR3 is a biologically inert, electron-dense nanoparticle.

It is a one-time treatment that is designed to be injected directly into solid tumor prior to a course of radiation, to amplify the antitumor activity of radiotherapy. NBTXR3 is made up of hafnium oxide, a sterile, inert material with high electron density that acts as a strong energy absorber and increases the amount of energy transferred to the tumor, which in turn leads to cell damage and death. This universal mode of action of NBTXR3 as a radioenhancer, offers broad application potential across 60% of patients with solid tumor that receive radiation during the course of their treatment.... The full potential of NBTXR3 is something that we have been actively evaluating in hundreds of patients across eight tumor types treated to date. We continue to see strong proof of concept data that supports a well-tolerated safety profile and robust anti-tumor activity with radiotherapy activated NBTXR3 treatment.

Our prioritized focus has been the late-stage development of NBTXR3 in head and neck cancer, which include an ongoing global registrational trial, the NANORAY-312 study, in elderly patients with locally advanced head and neck cancer, as well as treatment approach using radiotherapy activated NBTXR3 to help with local control of the injected tumor, as well as initially prime the immune system, followed by anti-PD-1 therapies. We believe this combination has the potential to be a game changer for cancer immunotherapy, and is supported by encouraging data from Study 1100, our Phase 1 trial in patients with advanced cancer, including those that are anti-PD-1 naive, as well as those whom anti-PD-1 therapy has failed. We also continue to generate additional early stage data to support the clinical potential of NBTXR3 across different solid tumor indications as part of our collaboration with MD Anderson.

This effort includes five ongoing clinical trials in advanced solid tumor with lung or liver metastases, recurrent or metastatic head and neck cancer, inoperable non-small cell lung cancer, esophageal cancer, and pancreatic cancer. As I mentioned earlier, the license agreement with Johnson & Johnson has a total potential value of $2.5 billion, and to this we can now add the $205 million related to the right in Asia, assigned by LianBio to J&J. The deal value include upfront and in-kind support, and a number of development and regulatory milestones for the first indication in head and neck cancer and lung cancer, along with sales milestones that together potentially total up to $1.8 billion. There are additional regulatory and development milestones for new indications that J&J may develop over time of up to $650 million in aggregate.

For any new indication that Nanobiotix will develop and bring to market, there will be an additional $220 million per new indication. Of course, the deal also includes tiered royalties that go from low teens to low twenties. In June, we have secured $114 million gross in funding, which includes several deal related payments and equity raise. This equity deal was supported by our major shareholder and also provided J&J the opportunity to become a Nanobiotix shareholder. As Bart will review in more depth shortly, we are pleased to have significantly strengthened our balance sheet, removed the EIB cash covenant, and extended our cash runway into the third quarter of 2025. Looking ahead, we're strongly positioned to further advance and maximize the therapeutic potential of NBTXR3 within the solid tumor treatment landscape.

Turning to our clinical progress, earlier this year, we reported positive final safety and efficacy data and the successful completion of Study 102, our phase 1 dose escalation and expansion study in head and neck cancer at the annual ASCO meeting. The robust anti-tumor efficacy and well-tolerated profile in a vulnerable elderly population with high comorbidity burden was encouraging, and included a 64 complete response rate and 82 overall response rate. We also saw a median progression-free survival of 16.9 months and a median overall survival of 23.1 months, which is nearly the double survival reported in historical data. These data inform on next steps and support the hypothesis underlying design of our registrational NANORAY-312 Phase 3 study.

Additional signs of efficacy in exploratory analysis presented at the 2023 ESMO Congress provided further confidence in our ongoing Phase 3 study, including a 42.8 months median overall survival observed in the 82% evaluable population, who had a response in the NBTXR3 injected lesion, compared to 18.1 months in the all treated population. Importantly, a positive correlation associated with objective response, PFS, and OS extension was observed in the radiotherapy activated NBTXR3 injected lesion. This high rate of response in over 80% of treated patients linked to the extended survival beyond 40 months, is encouraging and supports the potential of NBTXR3 to change treatment paradigm in this patient population. Importantly, there are several key aspects of this Phase 1 data that give us confidence in the design and potential outcome of our registrational NANORAY-312 study.

The first is the extended survival observed in this elderly and highly comorbid population. We have also applied learning from our Phase 1 study, which has the potential to optimize treatment outcome in the Phase 3 trial. This includes injection both of the primary lesion and the possibility to inject lymph nodes in the Phase 3 trial, instead of just the primary lesion, as was done in Phase 1 study. Additionally, 312 will enroll a broader population and will be stratified on comorbidities. Collectively, we believe this modification has potential for enhanced outcome over our Phase 1 findings. But let's be clear, if we reach similar outcome as our Phase 1 trial... then the 312 should be able to be successful.

We expect to report initial Phase 3 interim efficacy and safety data after 67% of planned PFS events in mid-2025, which, if positive, could enable eligibility for accelerated approval, as has been discussed with the U.S. FDA. In pancreatic cancer, we were pleased to report initial data from our Phase 1b study, led by our collaborator, partner, MD Anderson, supporting the potential of radiotherapy-activated NBTXR3 after cytostatic chemotherapy in patients with locally advanced pancreatic cancer at the AACR Special Conference on Pancreatic Cancer and ESMO. This trial focuses on patients with large tumors that are unable to undergo surgery and rely on radiation combined with chemotherapy as a key treatment option to help control the tumor. This initial Phase 1b dose escalation data support the feasibility and promising durable anti-tumor efficacy of radiotherapy-activated NBTXR3 in pancreatic cancer.

The ESMO data potentially help inform clinical trial development by establishing a recommended Phase 2 dose and demonstrating a favorable safety profile and a preliminary median overall survival of 23 months, which is longer than the 19.2 months median survival achieved in patients who previously received a chemotherapy induction followed by radiation, plus a second course of chemotherapy. In other words, the same center control patients receive one additional course of chemotherapy versus the NBTXR3 treated patients. To put this into perspective, when we look at the comparative data that have been previously obtained by MD Anderson, we are seeing promising therapeutic potential versus this historical control. We plan to discuss this data with our partner, MD Anderson, and Johnson & Johnson, to assess potential next steps for patients with pancreatic cancer.

In our effort to further advance clinical development and commercialization of NBTXR3, we were pleased to welcome industry veteran, Dr. Louis Kayitalire, to our executive leadership team as Chief Medical Officer. Dr. Louis Kayitalire brings an exceptional biopharmaceutical industry track record with proven success in development, registration, and commercialization of oncology therapeutics. His seasoned, innovative leadership has and will continue to be invaluable as we focus on maximizing the disruptive potential of our radioenhancer for millions of patients with cancer around the world. In the near ahead, we expect immunotherapy combination data from our Study 1100 trial in head and neck cancer, where we have seen encouraging activity in both PD-1 treatment-naive and refractory patients. We also expect initial chemotherapy combination data in esophageal cancer from an MD Anderson collaboration.

With that, I would like now to turn the call over to Bart to briefly discuss our financial results for the period. Bart?

Bart van Rhijn (CFO)

Thank you, Laurent. Good morning and good afternoon, everyone. As Laurent mentioned earlier, Nanobiotix has had an extremely productive year, 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, the pipeline and the product. More specifically, 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 that is far from the full potential we see possible with a therapy like NBTXR3.

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. To date, the company has received EUR 30 million as part of an upfront cash licensing fee, EUR 5 million for the first equity tranche, which was received post-signing, EUR 25 million as part of the second equity tranche, and we are due to receive EUR 20 million NANORAY-312 operational milestone. With these events, we have also addressed in a significant manner the financial overhang that was an understandable concern of market participants.

As of December 31st, 2023, Nanobiotix had EUR 75.3 million in cash and cash equivalents, compared to EUR 41.4 million as of December 31st, 2022. We are grateful for the continued support we received from existing shareholders and are pleased to welcome new shareholders in our midst. As previously disclosed, the European Investment Bank has agreed to the removal of the minimum cash and cash equivalent covenant from the company's EIB loan, effective October 13, 2023. As a result of the terms of this new agreement, namely the repayment of the PIK prepayment and the recent financing, the company has paid the EIB approximately EUR 500,000, which is 1% of the net equity proceeds, further to the equity milestone acceleration mechanism the company agreed upon.

To turn to the specifics of our revenues and expenses, our top line of EUR 36.2 million reflects an increase of EUR 31.4 million versus the EUR 4.8 million we recorded in 2022. This was primarily driven by the revenue recognized following the signing of the Janssen agreement. Our investment in NBTXR3 increased our R&D expenses approximately EUR 5.8 million to a total of EUR 38.4 million, due to primarily the investments related to the pivotal Phase 3 registrational study, the NANORAY-312, and our immunotherapy combination study 1100. Our SG&A expenses increased by EUR 4.2 million to EUR 22 million for the year ended December 31, 2023. This year-over-year increase reflects growth in employee costs and one-time business activities, including equity issuance costs, license agreement execution, and the termination of a services agreement.

Based on the current operating plan and financial projections, we anticipated the cash and cash equivalents of EUR 75.3 million as of December 31st, 2023, in combination with the $20 million milestone we are due to receive, results in a cash runway that extends into the third quarter of 2025. And now I will turn the call back to Laurent. Laurent?

Laurent Lévy (CEO)

Thank you, Bart. As you have heard today, we made incredible progress this year, advancing clinical development of NBTXR3, fostering strong strategic partnership to further maximize the potential of NBTXR3 and extending our runway through key milestones. The totality of clinical data continue to support the potential of NBTXR3 to offer a meaningful therapeutic benefit to potentially millions of patients in oncology. We are pleased with the progress we have made in our initial focus in head and neck cancer, as well as the expansion potential across other indications like pancreatic cancer. Looking ahead, we expect multiple clinical readouts in 2024, including immunotherapy combination data from Study 1100, and new data from the collaboration with MD Anderson.

With the recent strengthening of our balance sheet, we believe we are strongly poised to execute across our near-term milestone and work toward our mission of bringing nanotechnology-derived products like NBTXR3 to more patients worldwide. With that, I now ask the operator to begin our Q&A session. Operator?

Operator (participant)

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the number 1 on your cell phone keypad. You will hear a 3-tone prompt acknowledging your request, and your questions will be pulled in the order they are received. Should you wish to decline from the polling process, please press the star followed by the number 2. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Jonathan Chang from Leerink Partners. Your line is open.

Dylan Drakes (Senior Research Analyst)

This is Dylan Jason for Jonathan. Thanks for taking our question. First of all, could you provide any context for what we should be expecting to see regarding patient numbers, duration of follow-up, and potential readout in the upcoming ASCO update for Study 1100?

Craig West (SVP of Investor Relations)

Hi, this is Craig, the head of IR here at Nanobiotix. It's our understanding that some of our attendees have had trouble connecting to the webcast. I just wanna make sure that people know that we are aware of the problem. We will post the slides and the replay as soon as possible. We're very sorry for the inconvenience. And I'm sorry, could you repeat your question?

Dylan Drakes (Senior Research Analyst)

Yeah, no problem. This is Dylan Jason for Jonathan. Just wanted to ask if you could provide any context for what we should be expecting to see regarding patient numbers, duration of follow-up, or potential readouts in the upcoming ASCO update from Study 1100?

Laurent Lévy (CEO)

Hi, Jonathan. Thanks for the question. So, maybe for the audience, let's maybe recap what is this study and what is the intention here. So that's our Study 1100, which is a study that is made to define and observe safety and efficacy in different population, where treated with radiation therapy, NBTXR3, and checkpoint inhibitor in head and neck cancer. So maybe before to go into some of the detail on what we should expect to see at ASCO, as the title abstract have been released lately. Here, we're talking about patients that have received a certain number of line of treatment, pre-medicated, which have had radio, chemo, or surgery, followed by radiotherapy, and then after this first line of treatment, experience a relapse.

And when experiencing this relapse, have been eligible to go for PD-1 treatment. So if you want a comparator of such a baseline in population, you should look at trial like CheckMate 141 or Keynote-440. So in our trial, we have in the current expansion phase that is ongoing, split the teams in two different cohorts for head and neck patients. The first cohort being patients that are naive to PD-1, and the second cohort being patients that are refractory to PD-1. So the recruitments have been going very well. We expect to have a good number of patients to show both for refractory and naive to PD-1 patients for ASCO. And what we should expect in terms of data is, of course, safety, and importantly, the efficacy.

And in terms of efficacy, we should look at response rates as per RECIST, also the overall target lesion response and overall survival and TSS. So we think that achieving a good number of patient recruitment in this trial will start to really allow us to quantify the potential effect of NBTXR3, and it's both to amplify the response for naive patients and potentially to reverse the resistance in refractoriness to PD-1.

Dylan Drakes (Senior Research Analyst)

Great. Thank you so much.

Laurent Lévy (CEO)

I hope answer your question.

Dylan Drakes (Senior Research Analyst)

Yeah, I appreciate that. Thank you.

Laurent Lévy (CEO)

You're welcome.

Operator (participant)

Your next question comes from the line of Lucy Codrington from Jefferies. Your line is open.

Lucy Codrington (Analyst)

Hi there. Thank you for taking my questions. So, just a couple of one from me. So in terms of the lung cancer trial start that Janssen is planning, and then just, I guess, more generally about your relationship with Janssen, how regularly are you meeting to make these decisions, both about the lung cancer start, but also you mentioned about pancreatic cancer with the way, you know, a registrational strategy for IO combination. You know, when will we get more detail on these next indications beyond head and neck? Then secondly, still related to the Janssen relationship, what's the visibility on the in-kind funding for NANORAY-312 and kind of the cadence of that, and why... Is that included in your cash runway?

If it isn't, why isn't it? I was under the impression it would be near-term funding. And then finally, in terms of the mid-2025 readout for NANORAY-312, what's your confidence in that timeline? I do appreciate it is event-driven, but I guess, what's your comfort with your current cash runway, and will it get you to that data? And I guess related to that, an update, please, on the recruitment of NANORAY-312. Thank you.

Laurent Lévy (CEO)

Thank you, Lucy. That's a bunch of questions. Maybe let's start with the relationship with J&J and within the priority and how we've been shaping this collaboration since we signed last summer. So altogether, before going in some details about the question you've been asking, we've been working a lot with J&J in order to shape this collaboration. First of all, establishing the governance, then establishing joint team and working team. That I can tell you, we meet almost on daily basis to work. We also have a confirmation of priorities that we're moving forward in the three trial and the lung cancer program done by J&J. So those are the really two priority for the initial development in this program.

Something that you don't see, but we've been working a lot also in manufacturing, and also exploring potential other indication with the medical team internal at Nano and the J&J team. So that's a lot of underground work in order to shape this collaboration, and there's a lot of discussion ongoing to refine the best way to go to market with NBTXR3. And I can assure you that in due time we'll give you more information when things have been finalized and agreed with our partner. But at the time, we can't say much more on this. But be ensured that we're working with the J&J team on daily basis to shape this development and to try to bring NBTXR3 as fast as we can to the market.

Now, there was a question about when the lung cancer program or trial should start. Well, we can't talk for our partner, but be ensured that they have been working a lot on that and with our help from time to time. And as soon as we can tell you, we will inform you about this very specific and important program. Now, about the in-kind contribution that that's something that was in the contract, as you may notice. It's not in the current runway definition, but that's something that is also ongoing discussion with J&J on how to help, where to help, and how can we shape that. Maybe I will let Bart comment a little on that.

Bart van Rhijn (CFO)

Yeah, happy to. Thank you for the question, Lucy. So, for the audience, this is the in-kind contribution that was agreed upon in the license agreement, and that is in-kind support that will directly be funded by J&J from their own PNL. So it will not flow through our PNL, therefore, it doesn't influence our cash runway. However, it helps to accelerate the ongoing three trial study.

Laurent Lévy (CEO)

So now for the interim analysis of the three trial, as the previous guidance we've given, we continue to expect to have the right number of agents by mid-2025 to be able to do this readout. And as you may have noticed in our financial statement, that we have money up to or into Q3 2025. So maybe I will leave Bart to refine or give some context about the financing moving forward.

Bart van Rhijn (CFO)

Yeah, happy to, Laurent. Yes, the cash runway into Q3 of 2025,

... Further to the guidance that has been provided previously with regards to the interim, that continues to be our expectation. And as you may expect, in the license agreement that we've concluded with J&J, there is a significant number of milestones. Milestones are typically payable at key inflection points. And without being able to share anything more, that one could expect that at significant moments in time, that would trigger payments in order to sustainably finance the company going forward. That's all that I can share at this point in time, but I hope that that provides clarity.

Laurent Lévy (CEO)

So Lucy, I hope this answer your question. Would love to

Lucy Codrington (Analyst)

Sorry.

Laurent Lévy (CEO)

-um.

Lucy Codrington (Analyst)

No, it was very help-

Laurent Lévy (CEO)

Yes, please go ahead.

Lucy Codrington (Analyst)

Sorry, very helpful. Just to clarify on that last milestone thing, so other than the $20 million you've already included, those potential significant number of milestones, some of those could come before the mid-2025 readout to extend that beyond, comfortably beyond the data?

Laurent Lévy (CEO)

As you know, we're not at the liberty to disclose the sequence of the milestone, neither the events or the quantum that are into it. But I think from a logical perspective, we should assume that some of those milestones may come when some of the risking events or validating events will occur. And as we did mention in the past, there is a good proportion of this milestone, at least for the initial program, that are linked to head and neck and lung program. So not being able to tell you more, I think we could anticipate a number of milestone over time linked to this program.

Lucy Codrington (Analyst)

Okay, thank you.

Operator (participant)

Your next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Your line is open.

Swayampakula Ramakanth (Analyst)

Thank you. This is RK from H.C. Wainwright. Good afternoon, Laurent and Bart. A couple of questions, but they're related within the NANORAY-312 program. So the first question is, since you will be taking a couple of looks into the data, one for futility analysis and another for the interim safety and efficacy look around the pre-planned 67% of PFS events. Would there... And because you also stated that depending on how strong the data is, you could file for an accelerated approval. My question basically is: Would this impact the alpha in terms of statistical calculation when you're doing multiple looks before you decide before you see the interim data, especially for significance to file for an accelerated approval?

Laurent Lévy (CEO)

Thanks, RK. Yes, if we look at the design of this trial, there's a multiple number of events. First, the futility, then the interim readout, and the final readout of the data. There's a primary endpoint being PFS and two secondary OS, and as mentioned, there is a certain number of events that will trigger those roll out. And as per design of the protocol, those multiple loop will have an influence on the alpha. And also, when we have been designing this trial, we have been powering this trial to be good for OS, and therefore have been overpowered for the PFS. But all this obviously have been taken into account in the number of patients we need to recruit in order to get to the positive statistical benefit that we intend in this trial.

RK, if you want a bit more detail discussion, I think we can obviously go over the ClinicalTrials.gov protocol, and have a more precise discussion on this. We'll be happy to, or we can have a call with our CMO for that result.

Swayampakula Ramakanth (Analyst)

Certainly, certainly, we can take that offline. I just wanted to, you know, at a high level, I just wanted to check on that. And then the second question is on obviously beyond what we are talking today, you have multiple studies ongoing with MD Anderson, and I think I've asked this question multiple times, but so what is the appetite for Janssen in terms of picking up these other indications, whether it's esophagus, you know, the other solid tumors, like pancreatic, what do you think is their appetite, you know, going beyond what they're doing now?

Laurent Lévy (CEO)

Okay. So first, maybe let's remind the context of our collaboration and how it fits with the J&J licensing out. So in the J&J licensing out, that's a full licensing out worldwide now that they have taken back the rights from LianBio for development and commercialization of NBTXR3. So we have a relationship between Nanobiotix and J&J on that matter. We still have a collaboration with MD Anderson, which is compatible with this alliance with J&J. And so it's two different collaboration, one-one with MD Anderson and one-one with J&J. Nevertheless, we're all developing the same product with the same intention to try to maximize the impact for the patient.

Let's say that if I look at how this is split in terms of period of activity, for sure, when you think about a big company like J&J, their intention is to run some pivotal and randomized trial in order to get to market and start and preparing commercialization and so on, within standard of care or outside. So MD Anderson the spirit of the collaboration is more about how can we push the boundaries of medicine using NBTXR3, not only in the existing standard of care with radiation as a whole, but potentially beyond that. So I see the MDA collaboration more as a pushing the boundaries collaboration and also trying to find some signal in terms of efficacy that could help us to design future development.

So there's no three-party relationship in these two collaborations, but there is medical and scientific exchanges in order to make sure that what we do one way or the other is compatible. Now, as I mentioned, just previously in the call, part of the discussion with the interventional oncology group is about how and what could happen, where we could go after learning and having next. So there's a lot of discussion around that, and definitely what we do at MD Anderson is part of the information we use to inform that discussion. Unfortunately, I can't tell you more right now, even if there is a lot of discussion around all those matters.

Swayampakula Ramakanth (Analyst)

Thank you. Thank you, Laurent, for taking my question, and talk to you soon.

Laurent Lévy (CEO)

Thank you, RK.

Operator (participant)

Your next question comes from the line of Clemence Thiers from Stifel. Your line is open.

Clemence Thiers (Analyst)

Hi, thanks for taking my question. I'm stepping a bit away from the presentation, but I had a couple of questions regarding your Curadigm and Ocuity platform, which you kind of unveiled this year. Can you give us more color on your activity there, maybe at what stage of development you are? Is there any chance to see a candidate in clinic this year? And regarding Curadigm in particular, you had a collaboration with Sanofi back in 2021 for gene therapy. Could you maybe tell us if it's still ongoing, where you are now? And finally, still on this, are there any discussions ongoing with J&J about this platform? Thanks.

Laurent Lévy (CEO)

Thank you, Clemence. So as you mentioned, the two other technology platform we have at Nanobiotix. Maybe before to dig in and to just briefly explain what it is, just want to remind the philosophy in which we've been developing these three, three platform. So for Nanobiotix, the motto, since we've created this company, has been to try to find products or platform products that could help millions of patients. And also on the top of that, to have products or platforms that will be new, meaning we want to be the first one to develop what we are developing at Nanobiotix. And the latest point is that we want that to be broadly protected by intellectual property.

So far, we've been able to do that, and for the three different platform that potentially will generate multiple first-in-class products widely protected with IP. So we've been using this and have been able to develop that because we use nanophysics as a fundamental prerequisite to our different products. Why? Because we think when you use physics, then you have much less variability induced by biology, and therefore, you can start imagining products that could help a lot of patients. So that's why we've been using nanophysics instead of biology or chemistry so far. So now within this context, we've been developing the first platform, which is a radioenhancer platform that you know, and two other platforms, one which is linked to CNS disorder, and that's the name was mentioned as Ocuity.

This platform is about looking at the brain more as an electric circuit, rather than looking at the brain as a biological organ. When you start looking at degenerative disease in the brain or in the peripheral system, you can look and see that most of the deficiencies, they come or expressed through a misconnection between neuron or that conduction that is too fast or too slow or asynchronous. So we've been developing a number of nanoparticles that have the ability to change the way electricity is conducted, and this at the neuron level. So you can imagine that if we can have this particle in contact, like on the surface, inside or outside the neuron, we will really change the way electric conduction is done within a neuron or between neuron.

So this is just the fundamental of this technology platform that potentially will lead to multiple products and that's the less advanced platform, and also not the current focus for Nanobiotix. So you did mention Curadigm, which is, here again, a different approach, where we've been looking at why so many products cannot be delivered the right way, or how, why are we limited in terms of efficacy or safety? And I can take, for example, like the drug delivery system that have been used to deliver doxorubicin, irinotecan, or some others, but also the RNA-based LNP that face a number of problems when delivered IV or oncolytic virus on some other technology or approaches.

What makes a link between all the technology I've been mentioning is when you inject that IV, the liver will act as a strength filter and will capture the vast majority of this product and will not allow those products to go outside in the body. Therefore, you're limited by the way you can deliver, and that's why people are delivering oncolytic virus most of the time, directly where they want it to be, just like the LNP with RNA product. So looking at this, we thought that can we rethink the way products are delivered and can we change this? Can we do it differently? That's what led us to develop what we call the nanoprimer, which is a nanoparticle that you inject IV, and this particle will go in the liver as many other particles.

But it has been designed in a very specific way, so this particle will be sort of digested by the liver for a certain amount of time. And while the liver is busy digesting this particle, when you inject other type of products, they will go more freely through the liver, and therefore you change completely the biodistribution of this product. And more than changing things, you can allow to do things with this nanoprimer that you will not be allowed to do without. If I take RNA delivery particle as an example, very hard when you inject IV to go and target other, like, brain or lung or other type of organ. And with the nanoprimer, and we've been looking at different animal models, we are able to do that.

So there's a lot to do with this platform, as you can imagine, given the potential and the, the different approaches we could use, both in terms of product impact, but also in terms of therapeutic area. But a big part of the ongoing program internally is about defining the business model, defining how we're gonna move forward in different aspects of this product. And we expect to give an update on that before the end of this year. So we are talking about the stage of development. So it's a preclinical stage development, but we already have established a good number of proof of concept on different type of products. Now it's all about how we're gonna bring that to people, to patients, and how we're gonna bring that to market.

Given the potential of this platform on so many fronts, I think this will allow us for different type of business models, ranging from licensing out to in-house development for different products. But as I said, we'll tell you more before the year end on this matter. Now, you mentioned a collaboration with Sanofi that we've been establishing to try to test this platform with different type of therapies they have internally. So the collaboration went out well. We've been establishing some good data. Now, next steps or next potential step will be to explore further, but this obviously within the bigger context of establishing the right business model for the company with this platform.

Clemence Thiers (Analyst)

Okay. Thank you very much. And just, so did you discuss it with J&J, or are they only focused on?

Laurent Lévy (CEO)

No, for now, we don't-

Clemence Thiers (Analyst)

Right.

Laurent Lévy (CEO)

We haven't, we haven't been discussing with J&J about other technology platform. We're really focusing on the development of NBTXR3, as is the vast majority of our team.

Clemence Thiers (Analyst)

Okay. Make sense. Thank you very much.

Operator (participant)

Your next question comes from the line of Colin Bristow from UBS. Your line is open.

Elliott Bosco (Analyst)

Hi, this is Elliott Bosco on for, Colin Bristow. A few questions from me. You recently shared the recommended Phase 2 dose in inoperable lung cancer. I know that study was led by MD Anderson, but is there anything you can say on, next steps? And then, on the initial, Phase 1b to esophageal cancer, readout that you're expecting, are you able to share what might be, expected in the readout and, and what you see as the threshold for success? Thank you.

Laurent Lévy (CEO)

Thank you. Thank you for the question. So as you know, we have a number of clinical trial ongoing, done by and at MD Anderson. We've been, in the recent past, delivering two good news coming from this trial. The one on pancreatic cancer that we've been summarizing during the first part of the call, with potential good data coming in, and this trial now is getting clear close to completion, and we may expect to get additional data on this pancreatic cancer trial. Rightly, you've mentioned that we reached the RP2D in lung cancer trial, in one of the lung cancer trial at MDA. Just to reprise the context of this lung cancer trial.

As you know, radiation therapy is widely used in the lung cancer for different stage of the disease. Here at MDA, it was a very particular trial, where we wanted to help patients that already received radiation and relapsed, or did not respond well enough to radiation and had a local relapse within the field of previously radiated tissue. The goal here being the following: You can't reapply in a pre-radiated tissue, a full dose of directly radiation without risking damaging too much the tissue of the patient. So the idea of this trial was, first, is it feasible to re-radiate in the lung area safely? And two, does it provide benefit if we put R3 on the top of radiation, with a lower dose of radiation than the total dose it will give for a directly effect.

So we have established the RP2D, have expanded into the expansion phase, and the recruitment is moving well. And again, here, like in pancreatic, we should be able, hopefully, soon to give an update on this trial, including more patients than what we've been presenting, both on pancreatic and lung. But as you know, MDA is the sponsor of the trial. So at the end of the day, we're still depending on when and how they want to communicate the data, even though there is a joint steering committee and this collaboration works pretty well. So now for the esophageal cancer, that's a different type of approach.

We're talking about patients having esophageal cancer that cannot be removed surgically, and here, having a good local control is also very important for the potential improvement of survival of the patient, quality of life, and in some case, if we can get to a surgery that could remove the primary tumor. So the trials was recruiting, and we're discussing about potential reshaping of that within the understanding. And we don't have the exact timing for now on when this should happen and when we should be able to give the data. But as I said, when I look at esophageal, pancreatic, lung cancer, it's moving, and we should expect some update coming in the coming quarters.

Operator (participant)

Thank you. There are no further questions at this time. I would like to turn it back to Laurent Lévy for closing remarks.

Laurent Lévy (CEO)

Thank you. I would like to thank everyone for participating to this call, and be ensured that we will keep you updated as soon as we are moving forward in some of the developments we've been explaining today. I would like to personally thank you for all the support you've been expressing during the past year and decade in helping us to help millions of patients with our different technology platform. I hope to talk to you soon, and I wish you a great day.

Operator (participant)

Thank you, presenters, and ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.