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spk01: Good day and welcome to the Nanobiotics 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 Nanobiotics. Please go ahead.
spk09: Thank you. Good afternoon, good morning, and welcome to the Nanobiotics 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 Ryn, 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, InnoBiotics 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.
spk07: Thank you, Craig. And thank you, everyone, for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company's four years of working activity and financial results for 2023. For today's call, I would like to begin with an overview of our accomplishments and upcoming milestones 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 nanodiatics and our program on MBTXR3. Last summer, we entered into a $2.5 billion license agreement with Johnson Pharmaceuticals, a Johnson & Johnson company, to expand the worldwide potential of MBTXR3, a potential first-in-class regulatory answer with universal application across political norms. led in 2023, our partner, LiangBio, assigned its right to NVTXR3 in China and other Asian markets to Jensen, thus consolidating global development and commercialization rights with Jensen, which is now responsible for the $205 million in milestones 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 I trial in head and neck cancer, as well as initial data from our Phase I-B study supporting expansion potential in pancreatic cancer as part of an ongoing collaboration with MD Anderson. We will discuss these encouraging findings more in depth shortly. First, let's start with our Global Licensing for Development and Commercialization Agreement with Janssen for MDT-XR3. This partnership is designed to leverage the complementary strength of both companies, accelerating and broadening the treatment potential of MDT-XR3. 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 MDT-XR3, and importantly, further validate our platform and scientific approach. We believe that this collaboration with our partner at the International Oncology Group at J&J has the potential to impact the lives of many patients. We believe this because MBTXR3 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, For those new to the story, MBTXR3 is a biologically inert electron-dense nanoparticle. It is a one-time treatment that is designed to be injected directly into a solid tumor prior to a course of radiation to amplify the anti-tumor activity of radiotherapy. MBTXR3 is made up of asinine 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 NBT-XR3 as a radioenhancer offers broad application potential across 60% of patients with solid tumor that receive radiation during the course of their treatment. This potential of NVT-XR3 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 antitumor activity with radiotherapy-activated NVT-XR3 treatment. Our prioritized focus has been the late-stage development of NVT-XR3 in head and neck cancer which include an ongoing global registrational trial, the NAMORED 312 study, in elderly patients with locally advanced head and neck cancer, as well as treatment approach using radiative therapy-acidated MBTI-PAR3 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 of phase one trials 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 MDT-XR3 across different solid tumor indications as part of our collaboration with MD Anderson. This effort includes five ongoing clinical trials in advent solitumol with lung or liver metastasis, 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 $205 million related to the right in Asia, assigned by Liam Dyer to J&J. The deal values include advance and in-time 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 Janssen may develop over time of up to 650 million in aggregate. For any new indication that nanobiotics will develop and bring to market, there will be an additional $220 million per new indication. Of course, this deal also includes tiered royalties that go from low-yields to low-20s. In June, we have secured $114 million growth in funding, which includes several deals related to payment and equity rates. This equity deal was supported by a major shareholder and also provided GMJ the opportunity to become a nanobiotic shareholder. ADVANCE will review in more depth shortly we are pleased to have significantly strengthened our balance sheet, removed the PIB cash government, and expanded our cash flow rate into the third quarter of 2025. Looking ahead, we are strongly positioned to further advance and maximize the therapeutic potential of M-GTXR3 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 one or two. Our phase one dose escalation and expansion study in head and neck cancer at the annual AFCROM 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 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 inform on next steps and support the hypothesis underlining design of our registrational nanowire 312 phase 3 study. Additional signs of efficacy in exploratory analyzes presented at the 23th ESMO Congress provided further confidence in our ongoing SENS-3 study, including a 42.8-month median overall survival observed in the 82% evaluable population who had a response in the NB-TXR3 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 MBTXR3-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 MBTXR3 to change treatment paradigms in this patient population. Importantly, there are several key aspects of this Phase I data that give us confidence in the design and potential outcome of our registrational nanowire 312 study. The first is the extended survival observed in this elderly and highly comorbid population. We have also applied learning from our phase one study, which has the potential to optimize treatment outcome in the phase three trial. This includes injection both of the primary lesion and the possibility to inject lymph nodes in the phase three trial instead of just the primary lesion as was done in phase one study. Additionally, TREAT-well will enroll a broader population and will be stratified on comorbidities. Collectively, we believe this modification has potential for enhanced outcome over our phase one findings. But let's be clear, if we reach similar outcome as our phase one trial, then the TREAT-well should be able to be successful. We expect to report initial test-free interim efficacy and safety data after 67% of planned PFS add-ons in mid-25, which, if positive, could enable eligibility for accelerated approval had been discussed with the US 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 in DTXR3 after cytotoxic chemotherapy in patients with locally advanced pancreatic cancer at the ASCR 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 supports the feasibility and promising durable antitumor efficacy of radiotherapy-activated MBTX artery in temporary cancer. The ASMO data potentially helped 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 achieving patients who previously received a chemotherapy induction followed by radiation, plus a second course of chemotherapy. In other words, the same center-controlled patients received one additional course of chemotherapy versus the MDT-XR-treated patients. To put this into perspective, When we look at the comparative data that have been previously obtained by MD-Endoscan, we are seeing promising therapeutic potential versus this historical control. We plan to discuss this data with our partner MD-Endoscan and Johnson & Johnson to assess potential next steps for patients with pancreatic cancer. In our effort to further advance clinical development and commercialization of the MDT-XR3, we were pleased to welcome industry veteran, Dr. Rikai Tahir, to our executive leadership team as chief medical officer. Dr. Tahir brings an exceptional biopharmaceutical industry track record with proven success in development, registration, and commercialization of oncology therapeutics. Each season, innovative leadership has and will continue to be invaluable as we focus on maximizing the disruptive potential of our radionensers 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 P1 treatment naive and refractory patients. We also expect initial chemotherapy combination data in esophageal cancer from an Andy 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?
spk10: Thank you, Laurent. Good morning and good afternoon, everyone. As Laurent mentioned earlier, Nanobiotics 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 NPT-XR3. a pipeline in the process. More specifically, we began our collaboration with Johnson & Johnson through which we are working to bring MBTXR3 to the millions of patients that suffer from solid tumor malignancies that are amenable to treatment with radiotherapy. The first two indications targeted for development are planned to be head and neck cancers and lung cancers. But it is far from the full potential we see possible with a therapy like MBTXR3 And as you've just heard Laurent discuss, additional indications such as pancreatic cancer can, we believe, benefit from adding our potentially first-in-class 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 is part of the second equity tranche, and we are due to receive $20 million in the January 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 tranche of $25 million. And 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, nanobiotics at 75.3 million in cash and cash equivalents compared to 41.4 million euro 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 PIC prepayment and the recent financing, the company has paid the EIB approximately half a million euros, 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 €36.2 million reflects an increase of €31.4 million versus the €4.8 million we recorded in 2022. This was primarily driven by the revenue recognized following the signing of the Jensen Agreement. Our investment in MBTX R3 increased our R&D expenses approximately 5.8 million euros to a total of 38.4 million due to primarily the investments related to the pivotal phase three registration study, the NanoA312, and our immunotherapy combination study, 1100. Our SG&A expenses increased by 4.2 million euros to 22 million euros for the year ended December 31st, 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 equivalents of €75.3 million as of December 31, 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.
spk07: Laurent? Thank you, Bas. As you have heard today, we made incredible progress this year, advancing clinical development of NBTSR3. fostering strong strategic partnership to further maximize the potential of NVT expatriate and extending our runaway through chemisomes. The totality of clinical data continue to support the potential of NVT expatriate 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 poised to execute across our near-term milestone and work toward our mission of bringing nanotechnology-derived products like NBT-XR3 to more patients worldwide. With that, And I have the operator to begin our Q&A session. Operator?
spk01: Thank you. And 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 one on your cell phone keypad. You will hear a three-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 two. 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 Learing Partners. Your line is open.
spk05: This is Dylan J. It's not 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?
spk09: Hi, this is Craig, the head of IR here at Antibiotics. 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?
spk05: Yeah, no problem. This is Dylan Jakes 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.
spk07: 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 populations were treated with radiation therapy and DTXR3 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 abstract have been released lately. Here, we're talking about patients that have received a certain number of line of treatment premedicated. which have had radio chemo or chemo or surgery followed by radiotherapy. And then after this first line of treatment, experience a relapse. And when experiencing this relapse, I've 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 040. So in our trial, we have in the current expansion phase that is ongoing, split into two different cohorts for the next patient. 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 recruitment has been going really 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 rate, as per RASIST, also the all-target lesion response, and overall survival and PSS. 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 MBT-XR3. And it's both to amplify the response for naive patients and potentially to reverse the resistance in refractory patients to PD-1.
spk02: I hope that answers your question. Yeah, I appreciate that. Thank you.
spk08: You're welcome.
spk01: Your next question comes from the line of Lucy Codrington from Jefferies. Your line is open.
spk00: Hi there. Thank you for taking my questions. So just a couple of ones 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 a registrational strategy for IO combination. 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 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 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.
spk07: Thank you, Lucie. That's a bunch of questions. Maybe let's start with the relationship with GMJ and within the priority and how we've been shaping this collaboration since we signed last summer. So altogether, before going into 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 meet almost on daily basis to work. We also have a concern of priorities that we are moving forward in the treat well and the lung cancer program done by J&J. So those are the really two priority for us. 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 G&J team. So that's a lot of underground work in order to share this collaboration. And there's a lot of discussion ongoing to refine the best way to go to market with R3. And I can assure you that in due time, we'll give you 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 be sure that we're working with the J&J team on a 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 talk for our partners, but we ensure 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 contributions. That's in. 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 GMJ on how to help, where to help, and how can we shed that. Maybe I will let Barton to comment a little on that.
spk10: Yeah, happy to. Thank you for the question, Lucie. 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 free trial study.
spk07: 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 mid-25 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. Yeah, happy to, Laurent.
spk10: Yes, the Catherine Roy 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 infection points. And without being able to share anything more, but 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.
spk07: So, Lucie, I hope this answers your question. I would love to hear more. Yes, please go ahead.
spk00: 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-25 readout to extend that beyond, comfortably beyond the data.
spk07: As you know, we're not at the liberty to disclose the sequence of the milestone, 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 derisking events or validating events will occur. And as we did mention in the past, there is a good proportion of those milestones, 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 milestones over time linked to this program.
spk00: Okay, thank you.
spk01: And your next question comes from the line of Swayampakula Ramakant from HC Wainwright. Your line is open.
spk06: Thank you. This is RK from HC Wainwright. Good afternoon, Lauren and Bart. A couple of questions, but they're related. within the NanoRaid 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-planned 67% of PFS units, 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?
spk08: Thanks, Aki.
spk07: Yes, if we look at the design of this trial, there's a multiple number of events, first the facility, then the interim readout, and the final readout of the data. The primary endpoint being TFS and T-secondary OS. And as mentioned, there is a certain number of events that will trigger this readout. And after the design of the protocol, this 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 overpowered for the PSS. 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 benefits that we intend in this trial. Okay, if you want a bit more detailed discussion, I think we can over the clinicaltrials.gov 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.
spk06: 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. 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?
spk07: Okay, so first maybe let's remind the context of NDA collaboration and how it does fit with the GenJ licensing out. So in the GenJ licensing out, that's a full licensing out worldwide now that they have taken back the rights from ENBIO for development and commercialization of NBTXR3. So we have a relationship between nanobiotics 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-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 patients. Let's say that if I look at how this is splitted in terms of spirit 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. For MD Understand, the spirit of the collaboration is more about how can we push the boundaries of medicine using NVT-XR3, not only in the existing standard of care with radiation as a role, but potentially beyond that. So I see the NDA 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-parted 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. As I mentioned just previously in the call, part of the discussion with the interventional oncology group is about, okay, how and what could happen, where we could go after learning and head and neck. 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.
spk06: Thank you. Thank you, Laurent, for taking the question. And talk to you soon. Thank you, Akhil.
spk01: Your next question comes from the line of Clemence Sears from Stifel. Your line is open.
spk04: Hi. Thanks for taking the question. I'm stepping a bit away from the presentation, but I had a couple of questions regarding your QADIC and OQT platform, which you kind of unveiled this year. Can you give us more colors 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 QADIC 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 GNG about this platform? Thanks.
spk08: Thank you, Kynos.
spk07: So, as you mentioned, the two other ethnology platforms we have at Nanobiotics. Maybe before we dig in and to just briefly explain what it is, I just want to remind the philosophy in which we've been developing these three platforms. So for NanoBioTik, 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 would be new, meaning we want to be the first one to develop what we are developing at nanobiotics. 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 platforms that potentially will generate multiple first-in-class products widely protected with IP. So 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 of biology or chemistry so far. So now within this context, we've been developing the first platform, which is a radio and answer platform that you know, and two other platforms, one which is linked to CNS Disorder, And that's the name you've mentioned as Acuity. And this platform is about looking at the brain more as an electric circuit rather than looking at the brain as a biological organ. And 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 express through a misconnection between neurons 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 neurons. 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 nanobiotics. So you did mention curadime, which is here again a different approach where we've been looking at Why so many products cannot be delivered the right way? Or 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, and 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, it's very hard when you inject IV to go and target RNA. Other like brain or lung or other type of organ and we've done a primer 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 area. But a big part of the ongoing programming 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 concept on different types of products. Now it's all about how we're 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 types 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 types of therapies they have internally. So the collaboration went out well. We've been establishing some good data. Now the next step 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.
spk04: Okay. Thank you very much. So did you discuss it with J&J or are they only focused on J&J?
spk07: No, for now, we haven't been discussing with J&J about other technology platforms. We're really focusing on the development of NBGXR3, as is the vast majority of our team.
spk04: Okay, makes sense. Thank you very much.
spk01: Your next question comes from the line of Colin Birstow from UBS. Your line is open.
spk03: Hi, this is Elliot Bosco on for Colin Bristow. A few questions for me. You recently shared the recommended phase two 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 1B2 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? Thank you.
spk07: Thank you. Thank you for the question. So, as you know, we have a number of clinical trials 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 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 trials at MDA, just to re-precise the context of this lung cancer trial. As you know, radiation therapy is widely used in the lung cancer for different stages of the disease. Here at MDA, it was a very particular trial where we wanted to help patients that already received radiation and relapse 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 reapply in a pre-radiated tissue a full dose of therapeutic 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 benefits if we put R3 on the top of radiation with a lower dose of radiation than the total dose it would give for a therapeutic effect? So we have established the RP2D, have expanded it into the expansion phase, and the recruitment is moving well. And again, 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 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 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 trial is recruiting, 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 oesophageal pancreatic lung cancer, this moving, and we should expect some update coming in the coming quarters.
spk02: Thank you.
spk01: And there are no further questions at this time. I would like to turn it back to Laurent Lévy for closing remarks.
spk07: Thank you. So I would like to thank everyone for participating to this call and be sure that we'll 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 support 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. I wish you a great day.
spk01: 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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