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Nanobiotix S.A. (NBTX)

Q1 2024 Earnings Call· Wed, May 22, 2024

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Transcript

Operator

Operator

Good day, and welcome to the Nanobiotix Corporate Strategy Update and Q1 2024 Conference Call. [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.

Craig West

Analyst

Thank you. Good afternoon and good morning, and welcome to the Nanobiotix conference call to discuss updates to our NBTXR3 development plan and our first quarter. Joining me on the call today are Laurent Levy, Co-Founder and Chief Executive Officer; and Bart Van Rhijn, Chief Financial Officer, who will be available during the Q&A section. As a reminder, today's call is being webcast and will be available on our website for replay. I would like to remind you that this call will include forward-looking statements, which may include statements regarding the progress, success and timing of our ongoing and planned clinical trials, collaborations, regulatory filings, dates of presentation and future research and development efforts, among other things. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. They are subject to significant risks and uncertainties that could cause the company's actual results to differ materially from our current expectations. Accordingly, you are cautioned not to place undue reliance on forward-looking statements. Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and SEC in the United States, which are available in the Investor Relations section of our website, along with the press releases issued yesterday and today. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, Nanobiotix undertakes no obligation to update them to reflect subsequent events or future circumstances. Before turning the call over to Laurent, allow me to highlight that we announced in a separate press release this morning, our first quarter 2024 unaudited cash balance of €58.9 million and reaffirmed our cash runway into Q3 2025, which is inclusive of the $20 million milestone we meanwhile received. With that said, I'd like to turn the call over to Laurent. Please go ahead.

Laurent Levy

Analyst

Thank you, Craig, and thank you, everyone, for joining us today. As Craig mentioned, we issued a press release yesterday, highlighting the company's progress in the robust development of NBTXR3 and overview of our robust pipeline and expansion strategy. For today's call, I would like to begin with updates to our NBTXR3 collaboration and discuss our pathway to long-term growth. Then I will provide closing remarks before opening up the call for questions. Nanobiotix has been long known for the disruptive potential of NBTXR3, a nanoparticle treatment we've been developing for patients with cancer around the world. The accomplishments we have achieved through our 20-year history stand as a testament to the hard work of our team, the potential value the industry at large sees in our technology as well as the tremendous faith and confidence of our investors and other stakeholders all in our vision and our plans to get there. Last summer, we entered into a collaboration with Janssen worth potentially more than $2.5 billion plus royalties ranging from low teens to low 20s to expand the worldwide potential of our lead therapeutic candidate, NBTXR3, a potential first-in-class radioenhancer with universal application across the lead tumor. As part of the agreement, NBTXR3 is being developed and potentially commercialized globally by Janssen Pharmaceutica, a Johnson & Johnson company. Our global license agreement with Janssen has brought us the possibility to deliver outcome changing innovation for millions of patients. Today's focus with our partner is to secure the path to market for NBTXR3 and our commitment to realize our radioenhancers medical and economic value remains our most important goal. We believe this agreement underscores the therapeutic and market opportunity of NBTXR3 and importantly, further validates our platform and scientific approach. We believe that this collaboration with our partner has the…

Operator

Operator

[Operator Instructions] We will now take the first question coming from the line of Jonathan Chang from Leerink Partners. Please go ahead.

Jonathan Chang

Analyst

Hi guys. Thanks for taking the questions. First question, can you discuss how you're thinking about strategies to extend the company's cash runway? And then second question, can you provide any color on the alignment process with J&J on a global development plan for NBTXR3? And when we might hear more on the potential medium- to long-term opportunities? Thank you.

Laurent Levy

Analyst

Thanks, Jonathan. So maybe let's answer the question number two before going to question number one. So -- and maybe before, let's give some context in this shift in sponsorship. I think when we -- if we put ourselves one year ago, the focus of the company was about getting the 312 to the interim readout as fast as possible and it was the context in which we've been operating. Then last July, we've been signing this deal and the whole idea of this deal being to -- with our new partner, making sure that we can reach the largest number of patients possible and to grow the pie and to grow the market, if I may say. So we've been shifting from having all focus on getting this interim readout as fast as possible to focus, which is enlarging the number of indications, like having the lung cancer which is again a bigger market than head and neck, but also to go in a more secure or derisked way. So that's why along and around all this discussion we have had on what's the best timing to transfer the sponsorship, we ended up in this decision. So there have been some internal discussion, of course, at our partner level, then there have been an agreement at the JSE and then an endorsement by our Board. So that has been the process to get to this decision. And I think there's a big question about why now versus later. So first of all, in order to -- for J&J to be able to register the product, to start premarket activity and to launch the product effectively, they need to be sponsored of this trial. So there was a choice to do it either now or after the interim readout. Given the work and the heavy lifting that represents such a transfer for global trial with 500 patients, that will take months and months to get there effectively. So we thought the best thing to do is to do it now, take the burden now and don't have this burden post interim readout. Then after the interim readout assuming the data are positive, we can be fully focused and J&J could be fully focused on registering the products and starting up all market activities. So that's the context in which we operate, and we've been, of course, doing this press release. Now as you mentioned, this is opening a question about the current cash runway and financing, but maybe I'll let Bart answer that question.

Bart Van Rhijn

Analyst

Thank you, Laurent. Thank you, Jonathan, for the question. Just to recap, we believe that it's an important step forward in derisking of the assets, positioning it for success and really optimizing its potential for the benefit of patients and HCPs. As we indicated in the press release, the cash runway is unchanged. And yes, it implies that we need to finance through the updated timeline that we communicated. That said, we have much data to deliver between now and mid of 2025 to the milestones that we shared in the PR. And based on prior study results, we look forward with conviction to share those updates. And as any other biotech, we have multiple options, and we're very confident that we will work through this. And as you may appreciate, we cannot message on either the timing or the composition of sizing of the milestones.

Jonathan Chang

Analyst

Understood. Thanks for taking my questions.

Bart Van Rhijn

Analyst

Thank you.

Operator

Operator

Thank you. We will now take the next question from the line of Lucy Codrington from Jefferies. Please go ahead.

Lucy Codrington

Analyst

Hi there. Thanks for taking my questions. So just again, sorry, the transfer of the sponsorship just in terms of what does the timing look like for that whole process? It sounds like you do expect it to be done before then now at the interim readout in -- from first half '26. But I guess once that sponsorship is transferred, does J&J then take over financing of that trial, and therefore, that alone could help extend your cash runway where it happens sooner rather than later? And secondly, just your level of confidence in completing recruitment by first half '26 and therefore, the potential timing of that interim. And is there a minimum time after the completion of recruitment at which point that interim would need to take place? And then just in terms of the funding for the new indications that you might take into Phase 2, I guess, that's on top of your commitments to running -- funding 312 or if J&J would take over 312, that might free up some funds? Thank you.

Laurent Levy

Analyst

Thank you, Lucy. So first of all, the expected timing for the transfer of the 312. So we're early in the process as the intent has just been agreed in the past few days. So it will take time, that's for sure. But the intention, of course, is to complete that way before the interim readout. That's the whole intention of making this transfer now. Now in terms of -- obviously, this will add some investment on the partner side. Now we were just establishing what's the joint plan not only to transfer the trial, but to continue to run the trial up to the end, knowing that there would be no interruption of the trial during the transfer, that's the whole game we are trying to achieve here. So for financing part and how much this will cost Nano, how much will cost to our partner, we can't talk for our partner, but on our side, we think for now it's neutral, may look at it in the future to be a bit positive, but we can't say more right now because we are, as I said, early in the process. So now to your second question about H1 '26 to get the end of recruitment, I think that's a good estimate that we could qualify as a biotech as conservative estimate. But we think given the experience of recruitment we have had so far, plus what we expect to improve the equipment with the involvement of our partner, we should be able to reach this target. That's within the realm of high possibility. So now you asked a question about how the interim will play versus the last patient in and timing for that. So we expect, of course, to get the 283 event before, of course, at…

Lucy Codrington

Analyst

Thank you.

Operator

Operator

Thank you. We will now take the next question coming from the line of Suzanne van Voorthuizen from Van Lanschot Kempen. Please go ahead.

Chiara Montironi

Analyst

This is Chiara Montironi. I'm on behalf of Suzanne. Thanks a lot for taking my question. I have two questions, if possible. The first one will be, can you provide some color on how imminent will be the Phase 2 in lung cancer? And if it's not imminent, which are the gatekeeping items here? And the second question is more about the new programs, the new platform, Curadigm and Oocuity, which kind of updates should we expect in H2 '24? How concrete is that? Are you already working on some product candidates? Thank you.

Laurent Levy

Analyst

Thank you. So about lung cancer, which is the randomized Phase 2 trial that J&J is going to run, we've been publishing recently a good update explaining that FDA got the green line or get the green light about the protocol design. And obviously, that's going to trigger a number of activities and work around that by our partner. So we can't say more at that stage, but time always comes in what we do, then you can imagine that is the one is working heavily to get that done and started as soon as possible. I think we'll be able to give some update over time in agreement with our partner about the development of this clinical trial. Now for the question on Curadigm, the expected update we want to give in H2 is about how we're going to build the strategy and the business model around this new platform which could give not only one product but multiple products and in any case, multiple applications in different therapeutic areas. So as I think I have mentioned in the past few calls, that's a technology that offers many, many opportunities. And some of the key things and key questions we would like to answer and discuss with you in H2 is how we're going to build a sustainable business model with all different possibility we have with this type of technology, both on internal development and of course, external collaboration and business development activities. Now to your question, do we have already lead in this technology? Yes. We have multiple products that could be used to continue to develop this platform. But obviously, we will give you much more on this in H2.

Chiara Montironi

Analyst

Okay, thank you very much.

Laurent Levy

Analyst

Thank you.

Operator

Operator

Thank you. We will now take the next question from the line of Swayampakula Ramakanth from HCW. Please go ahead.

Swayampakula Ramakanth

Analyst

Thank you. This is RK from H.C. Wainwright. Good afternoon, Laurent. Just on the long term, thinking about Curadigm and Oocuity. So you have certainly generated a lot of validation on your NBTXR3 program. And how much of that validation can get transferred into these two new nanoparticle platforms? The reason for that question is, can you point to NBTXR3 if a partner comes and wants to talk about either Curadigm or Oocuity and is that enough? Or you need to generate data and only with that sort of data, would a partner actually sit at the table?

Laurent Levy

Analyst

Thank you, RK. That's a good question. Maybe just before I answer this question, I just want to reiterate that on NBTXR3, we still have a lot of work to do. And there is a lot of untapped value for this first product within the collaboration we have and the primary focus of this collaboration being -- and the company being to make that work and also to get the value of this product and collaboration recognized in the value of the company. Now we're starting to build the future as we've been discussing that. And in terms of Curadigm or Oocuity, there is a broader validation that our product is bringing in the introduction of nano physics-based mode of action into the healthcare. Now all products are different and have different therapeutic applications. Of course, we need to generate a number of data to get to a potential partnership and so on. The main difference being that for both platforms, Oocuity and Curadigm, we are talking here about a wide technology platform where we can not only work with product and codevelop our licensed product, but we could also start licensing part of the technology to partners for them to develop their own product. So again, there's multiple opportunities here from very short term to medium and long term, and that's what we intend to be able to explain to you in the second part of this year.

Swayampakula Ramakanth

Analyst

So should we expect some sort of preclinical data from both Curadigm and Oocuity if not in the second half, but over the next, say, 12 months? I'm you trying to do this parallel track. I'm just trying to understand how you would be developing all three programs, albeit at different levels of development, of course.

Laurent Levy

Analyst

Yes, without giving you any precise date for second half, yes, we'll be able to show to shareholders.

Swayampakula Ramakanth

Analyst

Perfect. Thank you. Thank you very much.

Laurent Levy

Analyst

Thank you.

Operator

Operator

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

Laurent Levy

Analyst

Thank you. And maybe before I make some closing remarks, I just want to remind the audience that we have been publishing that we will present at ASCO our data on the immuno-oncology program with our lead product, NBTXR3. And we think this data and this specific application of NBTXR3 is very important in regards to opening new doors and also potential new indication for Nanobiotix. So I hope to see you at that call when we will disclose and explain and discuss the data. And on that note, I'm going to thank you and wish you a very good day and rest of the week and let's stay tuned for the next piece of news that will come in the coming few days. Thank you very much. Have a great day.

Operator

Operator

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