Nanobiotix has recently shared their full-year 2023 financial and operating results, emphasizing the advancement of their lead product, NBTXR3, and the strength of their partnership with Johnson & Johnson. The company reported promising Phase 1 trial results in head and neck and pancreatic cancers, and disclosed its financial standing with a cash runway extending into Q3 2025. The call also covered the company's collaboration with MD Anderson on various clinical trials and the development of additional technology platforms.
Key Takeaways
- Nanobiotix's partnership with Johnson & Johnson for NBTXR3 could potentially be worth $2.5 billion, with $140 million already secured.
- Positive Phase 1 trial results for NBTXR3 in treating head and neck and pancreatic cancers.
- Dr. Louis Kayitalire appointed as Chief Medical Officer to support NBTXR3 development.
- $59 million raised through licensing fees and equity tranches from Johnson & Johnson.
- Cash and cash equivalents of EUR 75.3 million as of December 31, 2023.
- Collaboration with MD Anderson on clinical trials in pancreatic, lung, and esophageal cancers.
- Development of two additional technology platforms for CNS disorders and drug delivery systems.
Company Outlook
- Interim analysis of NANORAY-312 expected by mid-2025.
- Cash runway projected to last until Q3 2025, with additional funding anticipated from milestone payments.
- Collaboration with MD Anderson and Johnson & Johnson to shape future development plans.
- Expectations to provide updates on progress and business model before year-end.
Bearish Highlights
- Unable to disclose specific details regarding the sequence or amount of milestone payments.
- Exact timing for upcoming clinical trial updates remains uncertain.
Bullish Highlights
- Secured substantial funding and licensing agreements with a major industry partner.
- Demonstrated positive efficacy and safety in early-stage clinical trials.
- Broad potential for NBTXR3 in treating various solid tumors.
Misses
- No specific financial performance metrics or earnings figures were discussed in the call summary.
Q&A Highlights
- The company's focus remains on advancing NBTXR3 and exploring its full potential in treating solid tumors.
- Ongoing discussions with MD Anderson and Johnson & Johnson will inform the next steps in clinical development.
- Nanobiotix is working on shaping the collaboration with Johnson & Johnson and prioritizing the development of its platforms.
Nanobiotix (ticker: NANO.PA), in their latest earnings call, has provided a comprehensive update on their operational and financial status, highlighting the progression of their innovative NBTXR3 therapy and solidifying their collaboration with industry giants like Johnson & Johnson. The company's commitment to advancing cancer treatment is underscored by the positive data from their clinical trials and the strategic appointments to their leadership team. With a clear financial runway and ongoing collaborations, Nanobiotix is poised to continue its impactful work in the oncology field.
InvestingPro Insights
Nanobiotix's recent financial and operational update has shed light on their promising trajectory, especially with the development of NBTXR3. To provide a more in-depth perspective on the company's financial health and market performance, here are some key insights based on real-time data from InvestingPro:
InvestingPro Data:
- Market Cap (Adjusted): 273.72M USD, reflecting the company's current valuation in the market.
- Revenue Growth: An impressive 658.12% over the last twelve months as of Q4 2023, indicating significant strides in the company's sales performance.
- Return on Assets: -51.67% for the same period, which suggests challenges in generating profit from the company's assets.
InvestingPro Tips:
- Nanobiotix holds more cash than debt on its balance sheet, which can be a positive indicator of financial stability and the ability to fund ongoing operations and research.
- Despite a high return over the last year of 168.22%, analysts do not anticipate the company will be profitable this year, which is an important consideration for investors looking at the company's short-term earning potential.
For those interested in a deeper dive into Nanobiotix's financial and market performance, InvestingPro offers additional insights. There are currently five more InvestingPro Tips available, which can provide a more nuanced understanding of the company's outlook. To access these tips and more detailed analytics, visit https://www.investing.com/pro/NBTX and use the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Full transcript - Nanobiotix N (NBTX) Q4 2023:
Operator: 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: 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 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're 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 Levy: 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 operating activity and financial results for 2023. For today's call, I would like to begin with another view of our accomplishments and upcoming milestones before handing the call over to Bart to address the financial results. Then I will provide closing remarks before opening of the call for questions. 2023 was an incredible year of progress for Nanobiotix and our program on MBTXR3. Last summer we entered into a $2.5 billion license agreement with Johnson Pharmaceutical, a Johnson & Johnson company to expand the worldwide potential of MBTXR3, a potential first-in-class radioenhancer with universal application across solid tumors. Late in 2023, our partner LianBio, assigned its right to MBTXR3 in China and other Asian markets 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 anti-tumor 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 turns lead to cell damage and death. This universal model fraction of NBTXR3 as a radio enhancer offers broad application potential across 60% of patients with solid tumor that receive radiation during the course of their treatment. This broad potential of NBTXR3 is something that we have been actively evaluating in 100s of patients across age tumor type treated today. We continue to see strong proof-of-concept data that support a well-tolerated safety profile and robust anti-tumor activity with radiotherapy-activated NBTXR3 treatments. 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 and NBTXR3 to help with local control of the injected tumor, as well as initially prime the immune system, followed by anti-PD-1therapies. We believe this combination has the potential to be a game changer for cancer immunotherapy, and it's supported by encouraging data from study 1100. Our Phase 1 trials in patients with advanced cancer, including those that are anti-PD-1 naïve, as well as those whom anti-PD-1therapy has failed. We also continue to generate additional early-stage data to support the clinical potential of NBTXR3 across different solid tumor indication as part of our collaboration with MD Anderson. This effort includes 500 clinical trials in advanced solid tumor with lung or liver metastasis, recurrent or metastasis 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 $205 million related to the rights in Asia, that’s found by LianBio to J&J. The deal values include upfront and intangible and a number of developments and regulatory milestones for the certain indication in head and neck cancer and lung cancer, along with [third] (ph) milestone that together potentially total up to $1.8 billion. There are additional regulatory and development milestone for new indications that Janssen made as well over time of up to $650 million in aggregate. For any new indications that Nanobiotix will develop and bring to market, there will be an additional $220 million per annual indication. Of course, this deal also includes the royalties that go from that go from low-10s to low-20s. In June, we have secured $140 million gross in funding, which includes several deal-related payments and equity rate. This equity deal was supported by a major shareholder and also providing J&J the opportunity to become Nanobiotix shareholder. As part of the review in more depth shortly, we are pleased to have significantly strengthened our balance shift remove the [CID] (ph) cash movement and expanded our cash runway into the third quarter of ‘25. Looking ahead, we're strongly positioned to further advance and maximize the rapid 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 ASTRO meeting. The robust antitumor efficacy and well tolerated profile being a vulnerable elderly population with high comorbidity burden was encouraging and in today, the 64 complete response rate and 82 overall response rate. We also saw a median progression for survival of 16.9 months and a median overall survival of 23.1 months, which is nearly the double survival reported in historical data. This data informed on next step and support the positive underlying design of our registration NANORAY-312 Phase 3 study. Additional signs of efficacy in exploratory analysis presented at the 23 ESMO Congress provide further confidence in our ongoing Phase 3 study, including 42.8 months median overall survival observed in the 82% evaluable population would 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 like observed in the regulatory activated NBTXR3 injected lesion. This highlight of response in over 80% of treated patient linked to the extended survival beyond 40 months is encouraging and support the potential of NBTXR3 to change treatment having 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 expanded survival observed in this elderly and highly comorbid population. We have also applied learnings 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 was done in Phase 1 study. Additionally, 312 will enroll a broader population and will be stratified on comorbidities. Collectively, we believe this modification and potential for immense outcome over our Phase 1 finding. But let's be clear, if we reach similar outcome at 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 agents in mid-‘25, which is positive could enable eligibility for accelerated approval has been discussed with the PFS EFDA. 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 [Indiscernible] 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 antitumor efficacy of radiotherapy-activated and NBTXR3 in pancreatic cancer. The ESMO data potentially help in form clinical trial development by publishing 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 achieving patients will previously received a chemotherapy induction followed by radiation plus the second course of our chemotherapy. In other words, the same center controlled patients received one additional course of chemotherapy versus NBTXR3 treated patients. To put this into perspective, when we look at the comparative data that have been previously opened 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 will make step for patients with pancreatic cancer. In our efforts 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. Kayitalire brings an exceptional biopharmaceutical industry track recall with proven success in development, registration and commercialization of oncology therapy. He is seasoned innovative leadership have and will continue to be invaluable as we focus on maximizing the disruptive potential of our adherence for millions of patients with cancer around the world. In the year ahead, we expect immunotherapy combination data from our Study 1100 trials in head and neck cancer, where we have seen encouraging activity in both PD1 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 the financial results for the period. Bart?
Bart Van Rhijn: 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 NBTXR3 the pipeline in 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 minimal to treatment with radiotherapy. The first two indications targeted for development are planned to be head and neck cancers and lung cancers. But as far from the full potential, we see possible with a therapy like NBTXR3. And as you've just heard Laurent discussed additional indications such as pancreatic cancer, can, we believe, benefit from adding our potentially first-in-class radio enhancer to the treatment armamentarium. To-date, the company has received $30 million as part of an upfront cash licensing fee, $5 million for the first equity tranche, which was received post signing. $25 million as part of the second equity tranche and we are due to receive $20 million NANORAY-312 operational milestone. And as Laurent mentioned, the company completed an equity offering in which a total of $59 million was raised, which is inclusive of the aforementioned second equity fund of $25 million. And with these events, we have also addressed a significant manner the financial overhang that wasn't understandable concern of market participants. As of December 31, 2023 Nanobiotix had $75.3 million in cash and cash equivalents, compared to EUR 41.4 million as of December 31, 2022. We are grateful for the continued support we receive from existing shareholders, and are pleased to welcome new shareholders in our list. As previously disclosed, the European Investment Bank has agreed to the removal of the minimum cash and cash equivalent covenants from the company's CIB loan effective October 13, 2023. As a result of the terms of this new agreements, maybe the repayment of the prepayments and the recent financing the company has paid the EIB approximately EUR0.5 million, 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 EUR36.2 million reflects an increase of EUR31.4 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 EUR5.8 million to a total of EUR 38.4 million, due to primarily the investments related to the pivotal Phase 3 registration study, the NANORAY-312 and our immunotherapy combination Study 1100. Our SG&A expenses increased by EUR4.2 million to EUR22 million for the year ended December 31, 2023. This year-over-year increase reflects growth in [Indiscernible] costs and one-time business activities, including equity issuance costs, license agreement execution and the termination of the services agreement. Based on the current operating plan and financial projections, we anticipated the cash equivalents of EUR75.3 million as on December 31, 2023, in combination with the $20 million milestone we are due to receive results in a cash runway that stands into the third quarter of 2025. And now I will turn the call back to Laurent. Laurent?
Laurent Levy: 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 renewal through key milestones. The society 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 ‘24, 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 [Indiscernible] to execute across our near-term milestone and [Indiscernible] 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: Thank you. And ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from the line of Jonathan Chang from Leerink Partners. Your line is open.
Dylan Drakes: This is Dylan Drakes on for Jonathan. Thanks for taking our question. First of all, could you provide any context for what we should be expecting to see regarding vision numbers, duration of follow-up and potential readouts in the upcoming ASCO update for Study 1100?
Craig West: Hi, this is Craig. I'm 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 want to 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: And [Indiscernible] this is Dylan Drakes on 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 Levy: Hi, [Dylan] thanks for the question. So maybe for the audience, let's maybe recap what is the study and what is the intention here. So that's a Study 1100, which is a study that is made to define and absorb safety and efficacy in different population were treated with radiation therapy NBTXR3 and checkpoint inhibitor in head and neck cancer. So maybe before to go into some of the details on what we should expect to see at ASCO. As the title abstracts have been released lately. Here, we're talking about patients that had received a certain number of line of treatment premedicated, which have had radio, chemo or chemo of surgery followed by radiotherapy. And then after this first line of treatment, experienced a relapse. And when experiencing this relapse have been eligible to go for PD-1 treatment. So if you want to -- comparator of such a baseline in population, you should look at trials like CheckMate 141 or KEYNOTE 040. So in all trial, we have in the current extension phase that is ongoing split in two different calls for head and neck patients. The first call being patients that are naive to PD-1 and the second call being patients that are refractory to PD-1. So the equipment have been going very well. We expect to have a good number of patients to show both for refractory and naive to PD-1 patient for ASCO. And what we would expect in terms of data is, of course, the safety. And importantly, the efficacy. And in terms of efficacy, we should look at response rate after received also the all target lesion response and overall survival and PFS. 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 evolves to amplify the response for naive patients and potentially to reverse the resistance in refactorization to PD-1.
Dylan Drakes: Great. Thank you so much.
Laurent Levy: I hope [Multiple Speakers] your question.
Dylan Drakes: Yes. Appreciate that. Thank you.
Laurent Levy: You’re welcome.
Operator: Your next question comes from the line of Lucy Codrington from Jefferies. Your line is open.
Lucy Codrington: Hi, there. Thanks for taking my questions. So just a couple of one for 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 the Anderson, how regularly are you meeting to make these decisions, both about the lung cancer start, but also you mentioned about pancreatic cancer with the -- a registrational strategy for IO combination. When will we get more detail on these next indications beyond head and neck? Then secondly, still relates to the Janssen relationship. What's the visibility on the in-kind funding for NANORAY-312 and the kind of the cadence of that? And why is that included in your cash runway? And 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 time line? 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 Levy: 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 to 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 good earnings, then establishing joint team and working team, that I can tell you with almost on a daily basis to work. We also have a [Indiscernible] of priorities that we are moving forward in the 312 and the lung cancer program owned 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 indications with the medical team internal at Nano and the J&J team. So there's a lot of underground work in order to share this collaboration. And there's a lot of discussion ongoing to refine the pathway to go to market with R3. And I can ensure you that in due time, we'll give you a more information when things are being finalized and agreed with our partner. But at the time, we can't say much more on this. But being sure 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 that there was a question about when the lung cancer program or trial should start. Where we can talk for our partners that being sure that they have been working a lot on that and will all 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] (ph) contribution that's been. That's something that was in the contract, as you may notice. It's not in the current runaway definition but that's something that is also ongoing discussion with J&J on how to have, where to have and how can we share that. Maybe I would like Bart to comment a little on that.
Bart Van Rhijn: Yes, 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 P&L. So it will not flow through our P&L therefore, it doesn't influence our cash runway. However, it helps to accelerate the ongoing 312 study.
Laurent Levy: So now for the interim analysis of the 312. So as the previous guidance we've given, we continue to expect to have the right number of events by ‘25 to be able to do this readout. And as you may have noticed in our financial statements 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: Yes, happy to, Laurent. Yes, the cash flow into Q3 of ‘25 further to the guidance that has been provided previously with regards to the interim, that's 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 milestones. So milestones are typically payable at key inflection points. And without being able to share anything more, the one could expect that at significant moments in time that would trigger payments in order to sustain and refinance the company going forward. That's all that I can share at this point in time, but I hope that, that provides clarity.
Laurent Levy: So Lucy, I hope this answer your questions. Would love to more [Technical Difficulty].
Lucy Codrington: That was very helpful.
Laurent Levy: Yes, please go ahead.
Lucy Codrington: Sorry, very helpful. Just to clarify on that last milestone thing. So the -- other than the $20 million you've already included those potential significant number of milestones. Some of those could come before the mid-‘25 readout to extend that beyond -- comfortably beyond the data.
Laurent Levy: As you know, we're not at the liberty to disclose the sequence of the milestones either the events or the quantum that are into it. But I think from a logical perspective, what we should assume is that some of those milestones may come when some of the derisking events or validating event will occur. And as we did mention in the past, there is a good proportion of this milestone at least for the initial program following to head and neck and lung program. So not being to tell you more, I think we would anticipate a number of milestone over time linked to this program.
Lucy Codrington: Okay, thank you.
Operator: And your next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Your line is open.
Swayampakula Ramakanth: Thank you. This is RK from H.C. Wainwright. Good afternoon, Laurent and Bart, and for a couple of questions, but they are 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 on the pre plan, 67% of PFS. Would they -- 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 offer in terms of statistical calculation when you're doing multiple looks before you this -- before you see the interim data, especially for significant to file for an accelerated approval?
Laurent Levy: Thanks, RK. Yes, if we look at the design of this trial, there is a multiple number of events for the facility than the interim readout and the final of the readout of the data. There's the primary endpoint being PFS and the secondary OS. And as mentioned, there is a certain number of events that will trigger those readouts. And line of the product, 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, has been over for the PFS. But all in all, this obviously have been taken into account in the number of patients we need to work with in order to get to the positive statistical benefits that we intend in this trial. RK, if you want to add a bit more detailed discussion, I think we can hand over the clinical trial data protocol and have a more precise discussion on this, we'll be happy to -- we can have a call with our CMO for that regard.
Swayampakula Ramakanth: Certainly, certainly. We can take that offline. I just wanted to -- 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 [Indiscernible] the other solid tumors like pancreatic, what do you think is their appetite going beyond what they're doing now?
Bart Van Rhijn: Okay. So first, maybe let's remind the context of NDA collaboration and how it does between the J&J licensing out. So in the Janssen licensing out, that's a full licensing out worldwide now that they have taken back the rights from the Nanobio 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 collaborations, one with MD Anderson and one with J&J. Nevertheless, we all developing the same product with the same intention to try to maximize the impact for the patients. Let's say that if I look at how this pleated in terms of periods 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 in preparing commercialization and so on within standard-of-care or outside. For MD Anderson, the spirit of the collaboration is more about how can we prove bundle of medicine using NBTXR3, not only in the existing standard-of-care was radiation as a whole, but potentially beyond that. So ICD, MDA collaboration more as a pushing the boundaries collaboration and also trying to find some signal in term of efficacy that could help us to define future development. So there's no third-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. It is about, okay, how and what could happen, where we could go after learned in head and neck for the little 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 if there is a lot of discussion around all those matters.
Swayampakula Ramakanth: Thank you. Thank you, Laurent for taking my question and talk to you soon.
Laurent Levy: Thank you, RK.
Operator: Your next question comes from the line of Clemence Thiers from Stifel. Your line is open.
Clemence Thiers: Hi, thanks for taking my question. I'm stepping a bit away from the presentation, but I had a couple of questions regarding your [Indiscernible] and equity platform, which you kind of unveiled this year. Can you give us more color on your activities there, maybe at what stage of development you are? Is there any chance to see a candidate in clinic this year? And regarding [Indiscernible] in particular, you had a collaboration with Sanofi (NASDAQ:SNY) 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 Levy: Thank you, Clemence. So as you mentioned, the two other technology platform we have at Nanobiotix. Maybe first to dig in and to just briefly explain what it is. I just want to remind the philosophy in which we've been developing those three platforms. So for Nanobiotix the motor, since we've created this company have been to try to find product or platform products that could help millions of patients. And also on the top of that, to have a product or a platform that will be new, meaning we want to be the first one to develop what we are looking at Nanobiotix and the latest ones 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 product widely protected with IV. We've been using this and I've 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 viability 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 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 that was mentioned at [Indiscernible]. And this platform is about looking at the brand more as an electric circuit rather than looking at the brand as a biological organ. And when you start to looking at the generative disease in the brain or in peripheral system you can look and see that most of the deficiencies become or expressed through a misconnection between your own or that conviction that is too fast or too slow or [Indiscernible]. 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 change the way electric conduction is done within neuron or between neuron. So this is just the fundamental of this technology platform that potentially will lead to multiple products and then the less advanced platform. And also not the current focus for Nanobiotix. So you did mention [Indiscernible], which is here again, a different approach, where we've been looking at while 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 systems that have been used to deliver [Indiscernible] we've seen here in the PKN or some others. There will also be RNX-based LNP that faced a number of problems when we deliver IV or oncolytic virus on some other technology or approaches. What makes a link between all the technology have been mentioning is when you inject that IV, the liver will act as a strength feature, and we'll capture the vast majority of this product and will not allow those products to go outside in the body. Therefore, limited by the way you can deliver. And that's why people are delivering on oncolytic virus most of the time directly where they want 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 certain amount of time and while deliver is dealing, digesting this particle, when you inject all the type of products, they will go more freely through the leader. And therefore, you change completely the biodistribution of this product. And more than changing things you can allow to do things in this Nanoprimer, but you will not be allowed to do readout. If I take RNA delivery particle as an example, very hard when you inject IV to go and target or other like brain or lungs or other type of organs. And with Nanoprimer and we've been looking at different animal model 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 different approaches we could use, both in terms of product impact, but also in terms of therapeutic areas that a big part of the ongoing program internally is about defining the business model, defining how we're going to 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 clinical stage development, but we already have established a good number of proof-of-concepts on different type of products. Now it's all about how we are going to bring that to people to patients and how we're going to bring that to market. And even the potential of this platform on so many fronts, I think this will allow us for different type of business model ranging from licensing out to – in-house development for different products. But as I said, we will 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 assess this platform with different types of therapies they have internally. So the collaboration went out well, we've been establishing some good data. Now the next steps on the potential side 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: Okay. Thank you very much. And did you discuss it with J&J or are they only focused on R3?
Laurent Levy: No for now we don’t -- yes, 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: Okay, makes sense. Thank you very much.
Operator: Your next question comes from the line of Colin Bristow from UBS. Your line is open.
Elliott Bosco: Hi, this is Elliott Bosco on for Colin Bristow. A few questions for me. You recently shared the recommended Phase 2 dose in operable lung cancer. I know that study was led by MD Anderson, but is there anything you can say on our next steps? And then on the initial Phase 1b/2 esophageal cancer readout that you're expecting, are you able to share what might be expected in the readout and what you see as the threshold for success?
Laurent Levy: Thank you for the question. So as you know, we have a number of clinical trials ongoing, done by and act by MD Anderson. We've been in the recent past, delivering to 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 close to completion, and we may expect to get additional data this pancreatic cancer trial. Rightly, you've mentioned that we reached the RP2D in lung cancer trial in one of the lung cancer trial of MDA. Just to precise 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 NDA, it was a very particular trial, where we wanted to help patients that already received radiation and relapsed did not respond well enough to radiation and have 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 the radiated radiation without risking damaging too much the tissue of the patients. So the idea of this trial was first, is it feasible to re-radiate in the lung area safely and two, does it provide benefits if we put R3 on the top of radiation, with the lower dose of radiation than the total dose will be for a [diuretic] (ph) effect. So we have studied the RP2D have expanded into the expansion phase, and the recruitment is moving well. And again, we like in here, lacking pancreatic, we should be able hopefully soon to give an update on this trial, including more patients than what would be presented both on pancreatic and on 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 to communicate the data even though there is a joint steering committee and this collaboration works really 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 were put in, and we're discussing about potential reshaping of that with MD Anderson. And we don't have the exact timing for now on when this should happen and when it should be able to give the data. But as I said when I look at esophageal, pancreatic lung cancer [Indiscernible] moving and we should expect some update coming in the coming quarters.
Operator: Thank you. And there are no further questions at this time. I would like to turn it back to Laurent Levy for closing remarks.
Laurent Levy: Thank you. So I would like to thank everyone for participating to this call and being sure that we will keep you updated as soon as we are moving forward in some of the developments we've been explaining today. And I would like to personally thank you for all the supports you've been addressing during the past year and decade in helping us to have millions of patients with our different technology platform. And I hope to talk to you soon, and I wish you a great day.
Operator: Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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