4/25/2023

speaker
Operator

Good day, and thank you for standing by. Welcome to the Nanobiotics Business Update and Full Year 2022 Financial Results Conference Call. A slide presentation accompanying this call can be found at the investor section of the company's website at www.nanobiotics.com. 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 turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics.

speaker
Craig West

Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations 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 CSCC in the United States, including the URD and 20F filed yesterday, both of which are available in the investor relations section of our website, along with the press release issued yesterday highlighting our corporate and financial results for the period. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, nanobiotics undertakes no obligation to update them to reflect subsequent events or future circumstances. With that said, I'd like to turn the call over to Laurent. Please go ahead.

speaker
Craig West

Thank you, Craig. I would like to welcome everyone participating via conference call and webcast today. I would also like to welcome Greg to his first Nanobiotics conference call as he recently joined us as our new head of IR. If you haven't already met him, I'm sure there will be opportunities to do so soon. As Greg mentioned, we issued a press release yesterday highlighting the company's four years operating activity and financial results for 2022. For today's call, I would like to begin by providing an overview of our accomplishments and review upcoming milestones for each of our programs before turning the call over to Bart to address financial results after we will open the call for your question. Each year since initiating development of our lead candidate NBT-XR3, we have seen evidence continue to mount suggesting NBT-XR3 has the potential to change the way solid tumors are treated and improve outcomes for patients. This past year, not only saw this trend continue, but also provided an opportunity to showcase the strength and agility of Nanobatic's team and its partner, along with the commitment and support of our investigator, researcher, and most importantly, patient, who have continued to support our efforts. Against the backdrop of geopolitical unrest, the ongoing pandemic, and continued volatility in the capital market, the team remained focused on our mission and adapted to circumstances to successfully, first, initiate NANARATE 312, our global phase 3 trial in head and neck cancer in the U.S., Asia, and Europe, complete enrollment in Study 102, also in head and neck, generate new compelling data from our IO combination program, and early but very encouraging data on pancreatic cancer, and significantly reduce our operating expenses, secure future access to capital through an equity line, and restructure our debt obligation. As this achievement suggests, the capability and commitment of our team are as critical to our success as is the promise of NBT-XR3. It is further testament to both that during the challenges of 2022, we continue to attract new talent to join our mission to improve the lives of cancer patients through the development of NBT-XR3. This started early in the year when Strengthen, our executive leadership team, with the appointment of Dr. Leonard Farber, Chief Clinical and Medical Affairs Officer, who brings significant clinical experience and strong networks of peers committed to improve outcome for patients battling cancer. His insights and expertise are supported by a scientific advisory board comprised of leading global radiation, medical, and surgical oncologists involved in oncology treatment, decision-making, clinical trial investigation, and patient recruitment. Looking ahead, we are excited to share that we are expecting a new chief medical officer with extensive development expertise in oncology and immunotherapy to join the nano team in the third quarter of 2023. This anticipated addition is coupled with the expected arrival of a new head of regulatory scheduled to join the team later in Q2. We believe this addition will strengthen our clinical development program, better position us for registration, and help optimize our pipeline development. We look forward to working with this industry expert to help guide lead-stage development of our product, NBT-XR3. As you know, we started 2022 with the randomization of our first patient in NanoRed 312, our global phase 3 registrational study for patients with locally advanced head and neck cancer that are ineligible for platinum-based chemotherapy. This milestone set the tone for the year, and the team focused on driving the rollout of this study and initiation of sites across the globe. Their diligence and execution, supported by our partner at Leon Bio, have resulted in the activation of over 104 sites in 25 countries across core geographical sites in Europe, Asia, and United States as of year-end. I'm particularly pleased to be able to tell you that the team managed to accomplish this in just over a year in a challenging environment due to several factors such as competitive clinical trial and difficulties of a post-COVID world. Despite these achievements and continued progress, I will note that enrollment across country generally has been slower than initially anticipated, and we primarily attribute this to the complex and changing regulatory framework across EU, the continued impact of the COVID-19 pandemic, particularly in the US, which has led to longer than anticipated contract approval and site initiation due to limited site staffing. And similarly in Asia, COVID protection measure and regionally lockdown that persisted intermittently through 2022. And finally, we had to replace the Ukrainian and Russian site that were originally selected. Since the initiation, of NanoRay 312, we've been monitoring progress closely and have implemented several measures to increase the efficiency and speed of the trial rollout. The primary focus in 2022 was to increase sites and countries and to decrease the time between regional regulatory approval, contracting, and site activation. This has included increasing both virtual and in-person support for the clinical operation and medical affairs team, both before and after site initiation to improve site engagement and increase support for key members of the site study team. While the longer-than-anticipated regulatory and site activation process has resulted in a shift in the early enrollment, we are confident that with most regional regulatory approvals complete or in the final stage, we can move quickly to onboard the remaining target site plan for Nanowrite 312. and are reassured by the uptick in the enrollment we are seeing following the addition of new sites and the implementation of our high-touch clinical operation engagement strategy. We expect continued progress in adding sites and seeing the recently added site initiate enrollment. Further, through the increasingly close partnership with investigators fostered by this effort, we identified a new factor that could facilitate patient enrollment, and as a result, are close to the finalization of a minor protocol amendment to clarify and ease the inclusion criteria and simplify patient identification, screening, and enrollment without changing the overall target patient population. As we are ramping up our global registration study in 2022, we are also nearing completion of the study 102. As a reminder, study 102 is a dose escalation and expansion study in a similar head and neck cancer population that continues to demonstrate promising activity and was a driver in our decision to pursue registration in head and neck cancer as the first global registration pathway for NBT-XR3. Early in the year 23, we completed enrollment in study 102, expansion phase. And you will recall in February 2022, we reported an interim update with an ongoing median overall survival of 17.9 months in all treated population and 23 months in the available patient population. We are planning to present top-line safety and efficacy data from the full study population in the second half of 2023, and plan to submit this data for presentation at a medical meeting. We are also planning additional post-doc analysis in 2023 that we believe will add to our understanding of the activity of NBTX artery in head and neck cancer and further inform our assumption in the Nanorad 312. We believe the continued improvement in survival benefit already demonstrated in study 102 reinforces the probability of success for study 312 and suggests the anticipated delta between treatment and control arm may be larger than initially anticipated. If the final analysis remain in line with previously reported outcome, we believe this could potentially shorten the predicted overall time to expect data in the non-array 312. With this potential robustness in data, coupled with operational efficiency, we expect, as planned, the interim efficacy and safety analysis for pivotal Nanowire 312 trial after 67% of planned event in the second half of 2024. The fertility analysis, more heavily impacted by the first few months in study launch, will be conducted following 25% of planned event, which is anticipated now to be in the first half of 2024. Another treatment approach. we are actively pursuing is using radiotherapy-activated NBT-XR3 to initially prime the immune system, followed by anti-PD-1 therapies. This combination has potential to be a game changer for cancer immunotherapy and is supported by encouraging data from study 1100 of phase one dose escalation and expansion trial in patients with advanced cancer. In 2022, we completed a dose escalation phase of this study, establishing a recommended phase two dose and open enrollment in the expansion phase. As a result of progress in this program, we had the opportunity to present an update at the CITC conference in 2022, demonstrating durable response, including eight patients with over six months of disease control and five patients receiving disease control over than 12 months. This results continued to demonstrate not only improved therapeutic response among PD-1 treatment-naive patients, but showed meaningful response among patients who had previously seen their cancer progress despite PD-1 therapy. We look forward to providing future updates from Study 1100 as we continue the expansion phase of the study in the coming year. The positive activity seen in study 11 and greater has supported our plan for phase 3 registrational program for patients with locally recurrent or recurrent or metastatic head and neck cancer that are resistant to PD-1 therapy. In the first half of 2022, we received preliminary feedback from the FDA suggesting a single randomized controlled trial that include a pre-specified comparative analysis of the overall response rate may support accelerated approval. pending confirmation of clinical benefit based on overall survival results of the same trial. Initially, we plan to submit a protocol to the FDA on a potential registration or pathway for a BTXR3 immunotherapy approach in the first quarter of 2023. However, given we'll have a new CMO joining in the third quarter, we plan to consult with the incoming CMO prior to continue discussion with FDA. This individual has extensive experience in immunotherapy drug development, and given the significance of the program, interest in optimizing enrollment efficiency and ensuring we are building a fundamental protocol supportive of regulatory requirements and commercialization in a competitive landscape, we have decided for first review the current data and future program with our new CMO. Based on this, we expect to provide an update for our NBT-XR3 immunotherapy approach in the third quarter of 2023. Further expansion, opportunities for NBT-XR3 are actively being explored as part of the ongoing collaboration with the University of Texas MD Anderson Cancer Center. Of note, we have determined the recommended phase 2 dose for NBT-XR3 in pancreatic ductal adenocarcinoma and the principal investigator shared positive preliminary qualitative efficacy data in the fourth quarter of 2022. MD Anderson expects to present preliminary phase 1b dose escalation safety in pancreatic cancer in the second half of 2023. We look forward to the continued progress in this study, and as the dose expansion phase gets underway, a borderline respectable patients become eligible for an enrollment alongside locally advanced patients evaluated in the dose escalation phase. In addition to the upcoming data expected from pancreatic trial, MD Anderson has made significant progress in its phase one trial of NBT-XR3 in non-small cell lung cancer and expect to determine a recommended phase two dose in this study in the second half of this year. As you recall, They are also leading a phase 1 trial of NBT-XR3 in combination with chemotherapy for patients with esophageal cancer and are progressing toward an anticipated recommended phase 2 dose in 2024. Given their shift toward proton therapy in treating this patient, the study presents an interesting opportunity to validate prior preclinical data suggesting the safety and potential benefit of combining NBT-XR3 with proton therapy, which theoretically offer a reduction in the radiation exposure to healthy neighboring tissue wise improvement of the therapeutic ratio. MD Anderson is in the process to modify the existing protocol to allow for introduction of proton therapy for a cohort of patients in this study. At this juncture, we anticipate the study team reaching a recommended phase two dose under the existing intensity modulated radiation therapy protocol before introducing a second radiation therapy treatment modality sometime in 2024. And finally, I would like to note that MDA is working on additional clinical study in different patient population that we have not disclosed before. And we'll have more to say about this development in the future. Finally, I would like to highlight that we have many value inflection point, see here in the coming 12, 24 months across all of our program. We believe that NBT-XR3 has the potential to enhance the utility of radiation therapy in many tumors, and we are moving on many fronts to make this vision a reality. I would like now to turn the call to Bart to briefly discuss our financial results for the period. Bart?

speaker
Craig

Thank you, Laurent. As Laurent mentioned, the enrollment of our first patient in NOA312 provided an exciting start to 2022, and our commitment to advancing this study remained our priority. defining how we navigated the remainder of the year. As the broader economic pressure and market volatility persisted, we took quick action early in the second quarter to significantly expand our cost control efforts initiated in 2021 by prioritizing investment in NRA 312 and Study 1100, scaling back preclinical programs and optimizing manufacturing and infrastructure expense to ensure we were well positioned to execute our core programs. The results of these efforts to enhance operational efficiencies and improve our cost basis across all our programs are evident in the financial results we report yesterday, where we see only a modest increase in R&D expense of approximately 2 million euros compared to 2021, despite the initiation of our pivotal phase three registration study, the continuation of study 102, and our ongoing immunotherapy combination study 1100. Likewise, you will note SG&A expenses decreased by 1.6 million euro, or 8.1%, from 19.4 million euro for the year ended December 31st, 2021, to 17.9 million for the year ended December 31st, 2022, reflecting our efforts to rationalize SG&A expenses and internalize key functions. While the company did not generate revenue in 2022, We successfully expanded eligible expenses and increased our overall research tax credit as a result by more than 60% year-over-year, and a portion of this gain represents a recurring increase to this credit. As a result, our total income increased significantly to €4.8 million for the year ended December 31, 2022, compared to €2.6 million for the year ended December 31, 2021. To further improve our financial flexibility and extend our operating runway, we've successfully restructured €30.7 million in outstanding debt with the European Investment Bank to significantly reduce near-term expense and better align our debt obligations with our anticipated development timelines. While the impact on our cash runway is clearly favorable, the restructuring resulted in a negative one-off valuation impact of €6.9 million. Combined with higher interest costs on the loan and lower foreign exchange gains, our net loss for 2022 was €57 million or €1.64 per share for the 12-month period ended December 31st, 2022. This compares to the net loss of €47 million for €1.35 per share for the year ended December 31st, 2021. You will also recall that we took steps to ensure future access to capital by securing an equity financing line through CAFRA February in the second quarter of 2022. While we have not yet tapped this equity line, we have the full authority to activate or suspend access to capital through this facility at any time at our sole discretion. As of December 31st, 2022, Nanobiotics had €41.4 million in cash-in-cash equivalents, compared to 83.9 million euro as of December 31st, 2021. Our press release that we released last night notes that our cash combined with our equity-like financing will fund operations into the third quarter of this year, which is a shorter runway than our previous guidance into the first quarter of 2024. Our loan with the EAB carries a covenant requiring the cash balance of at 25.3 million, which is equivalent to the outstanding principle we are now getting closer to. The EIB has granted the temporary waiver of this requirement of 50 million euros until December 31st. The temporary waiver will be automatically extended until January 31st, 2024, with the signing of a business development partnership, collaborative or strategic alliance. Because the company is not reporting such an event at this time, The waiver is assumed by us and our auditors to be expiring on July 31st. And because our projected cash and cash equivalence balance is expected to decline below the 25.3 million level in Q3, we are reporting a cash runway that extends only to that time based on the conservative series of assumptions that include no business development deals, no new financing, and the assumption the EFU will exercise the government's and seek repayment of the loan in full. And now I will turn the call back to Laurent. Laurent?

speaker
Craig West

Thank you, Bart. In 2022, we continued our prioritized focus on further advancing MBTI-exhaustive treatment of head and neck cancer. To date, the totality of clinical data continue to support the potential of our product to offer a meaningful therapeutic benefit to a large number of patients in oncology. Our initial focus in head and neck cancer is establishing a framework that can be expanded and replicated across other solitumole. And as a reminder, we know that around 60% of all cancer patients will receive radiation therapy. With the recent strengthening of our operation and executive leadership, we believe we are well positioned to execute across our new-term catalyst through the year. Looking ahead, 2023 will be a foundational year for several reasons, including different milestones and clinical data that we should expect. On our primary focus, head and neck cancer, We will have the final data coming from the Phase 1-2, Study 102, also an update on the 1100, and we continue and we will continue to progress in the Pivotal Trial Nano X-Ray 312 to prepare as planned the interim readout for H224. In addition to our priority focus head and neck, we will get the first data coming from our large collaboration with MD Anderson including pancreatic cancer and lung cancer trial results. With that, I will now have the operator to begin our Q&A session. Operator?

speaker
Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions. With Evercore ISI, please proceed with your questions.

speaker
Jennifer

Hey, guys. Thanks for taking my question. Let's start with the head and neck studies. I'd love, Lauren, if you could give us some more color on the protocol amendment you're talking about for 312 that might increase enrollment rate. And sort of relatedly, I noticed you're sticking to guidance data in the second half of 24. You also alluded to the possibility that there's some acceleration possible there based on Study 102 readout. Can you talk about the pushes and pulls there and how much this could impact a timeline to the 312 readout?

speaker
Craig West

Sure. Thank you, Jennifer, for the question. So head and neck study pivotal trial, as you know, is a randomized test-treat study that is run globally, U.S., Asia, and Europe. And here, that's a 500-patient trial, randomized one-to-one, where the embryo or partner will treat 100% out of the 100 patients, so it's out of the 500 total. So to date, what we've been seeing is After a slow start of this trial, as expected in such a complex time with the war in Ukraine and the end of the COVID period, we're seeing a good ramping up of the patient work treatment right now. And I've been able across the year to get much more sites activated and also open new countries that were not initially planned. in order to compensate the loss of Ukraine and Russia and also the slow start of the trial. In addition to that, we looked at real world and discussed with our investigator in this trial to look at how can we ease the patient recruitment in this trial. So we've been doing some minor amendments in order to facilitate the number of patients that could have access to this trial and that includes but not limited to some better or easier definition of what would be the eligibility to cisplatin in order to include more patients. We also have included a bit more patients in terms of TNN definition and have the previous background and recall data from the patient entering the trial. So all this, we think, will help to accelerate the recruitment rate. And just of note, To date, we have only a subpart of the final number of sites that we expect that are currently recruiting. There are still sites happening. So we expect two things that make us think that we'll have another inflection point in the recruitment rate is the increasing number of sites recruiting and disarmament of the protocol that will start being active in sites within the next two months. So that's for the 312 itself. I think looking now at the 102 trial, which was the first part of the development in head and neck cancer, so that's a phase 1-2 that includes an escalation part and an expansion part where we've been treating a total of 72 patients in a similar population. We've seen already in the past that the overall survival of the evaluated population in this trial was around 23 months. and we expect to be able to report final data later this year that includes all the patients with at least 12 months follow-up, but we expect to be quite similar to what we have seen so far. Now, what is interesting is that we continue to dig in the data we have generated in this trial, and we expect to report on the top of what was planned after protocol some additional data that could help us to understand how this should play out in the 312 trial. In all regards, we think we are confident given what we have seen so far and increase our internal probability of success of the 312 based on what we have seen so far.

speaker
Jennifer

Okay, it makes sense. One more from me. I would love to hear more about your runway assumptions. I understand the updated runway doesn't include the equity line or other systems of capital and is making conservative assumptions about this debt covenant. What would the runway be if you did include all of your anticipated, not additional BD, but already negotiated equity lines full access to the debt and no covenants, what would the less conservative runway look like?

speaker
Craig

Thank you, John, for the question. This is Barton and Ryan. Debt would not have changed in what we've guided to previously, which would be Q1 of 24.

speaker
John

Okay. Thank you very much. Thank you. Our next questions will come from the line of Elliot Bosco with UBS.

speaker
Operator

Please proceed with your questions.

speaker
spk05

Hi, everyone. Elliot Bosco on for Colin Bristow from UBS. Another one on NanoRay 312 recruitment. Could you elaborate a little bit more on some of the regulatory challenges you're facing? And additionally, could you speak to the amount of sites that needed to be replaced? or incrementally added through some of the challenges. And then last question, could you provide additional commentary on your strategy for potential collaborations or partnerships? Thank you.

speaker
Craig West

Thank you. So in terms of the regulatory challenge, I think in Europe, as we know, our product has a medical device status. and for most of the rest of the world is a drug. And as there is a fundamental reshaping in the medical device status in Europe and regulation around that, we went through some hurdles in order to connect our old regulatory system versus new regulatory system in Europe. So we went through a number of interactions with agencies in order to connect the dots and to be able to start the trial. So this has been causing some delays, which did not happen in other countries. In Asia, we've seen some lockdown due to the COVID. No later than end of last year and beginning of this year was still the case, but now it's reopened. And for the U.S., the main hurdle was about the COVID tail, where it has slowed down most of the activities in hospitals. We think now everything is back to normal, and we're progressing well on every front. Now, in terms of replacing the sites that have been closed in Ukraine and Russia beginning of last year, we've been opening more sites in other countries that were already open, like France and Spain and others, but also have added two or three other countries in order to compensate that. So the idea here was to make sure that by adding those sites in existing or new countries will really compensate the exclusion of Russia and Ukraine at the beginning. And the little start, the start that had been a little slow versus what expected. But the good thing is now we see a very good ramp up in terms of recruitment and our biostatistician with the real world life recruitment rate that we see today and the ramp up we see in site activation, we maintain our guidance to get the interim readout second half of 24. And sorry, what was the last part of the question? Yes, partnership, right?

speaker
spk05

Yep, your strategy to partnerships, collaborations. Thank you.

speaker
Craig West

Okay. So just maybe a a piece of context, I think we all see how the market is for the past 18 months, two years, and even a bit more. So in an efficient market, it will make sense and would that make sense to raise more money in order to pass the interim in order to create more value. And after that step, maybe establishing some partnership and collaboration with industry. Now, as we all see, the market is not what we would hold high as expected to be, so we changed our strategy in the recent past, and we see collaboration or industrial partnership as a key option for Nano in order to move forward and guarantee that we can reach a lot of patients and also guaranteeing the value for our shareholders.

speaker
John

Thank you. That's all from me. Thank you.

speaker
Operator

Our next question has come from the line of RK with HC Wainwright. Please proceed with your questions.

speaker
MD Anderson

Thank you. Good morning, Ron and Bert. Just a couple of quick questions. I'm just trying to find out if there's going to be any clinical data presentations at ASCO coming up. And also, when MD Anderson releases data on pancreatic cancer later this year, And how would you, how are you thinking about taking this indication forward, you know, expecting this data to be positive from here?

speaker
Craig West

Thank you for the question. So, yes, we expect at ASCO and other conference for the second part of the year to present new data with our program. We will disclose in due time at which conference, obviously, we will present different data we have, but as I did mention briefly, we expect to present the final data of the 102 study and also some other data coming from this study, an update on the 1100, and the trial coming from MD Anderson. As far as MD Anderson is concerned, we wait to get the lung cancer trial first results but also the pancreatic cancer trials data. I think that's, as you mentioned, a very interesting trial because we think here we could have a big impact for the patient. And what we should look at when the data are coming out is the population we are treating here. We are talking about locally advanced pancreatic cancer patients that are fully inoperable. And for those patients, usually there is not much of a therapeutic option. What we've been doing after this patient getting a round of chemo, as the standard of care is proposed, we have been injecting nano X-ray and then activated by radiation and looked at the outcome for the patient. So what will be important here is to see how much of this patient we can stabilize, how much potentially we could have a response, which is rare in this population. Even more rare is how many of these patients could get surgery coming from inoperable to operable. And so all this data will be presented and for you to know we also have started the expansion part of this trial that we expect to conclude before the end of the year. And based on all this data, we think we should be able to propose a next step for pancreatic cancer patients. Now what's not yet decided is the format of this next step Would it be a few-year-old trial? Would it be something else? So that will be discussed a bit further, and I think we'll give an update on that when we present the data of this trial.

speaker
MD Anderson

Thank you, Laurent. Thanks for taking the question.

speaker
John

Thank you, Aki. Thank you. Our next questions come from the line of Clemente Passat with BNP Paribas.

speaker
Operator

Please proceed with your questions.

speaker
spk00

Hello. Thank you for taking my question. Just one about your relationship with the EIB. You advised that the EIB is willing to extend for six months the requirement of 15 million in account instead of 25. But the condition is to find a partner. And have in mind your CE mark in the STS program. And did they request or strongly suggest you to start the commercial phase on this program in Europe? And finally, are you in touch with potential partners to do that? Thank you.

speaker
Craig West

Thanks for the question. I think the STS is an interesting and important question. As you know, we've been successful in running a pre-randomized trial proving the superiority of MBT-XR3 over the standard of care in a very hard-to-treat patient population, which is locally advanced sub-tissue sarcoma patients. Now we also obtained the C-mark for that a few years ago. And the idea here is to capitalize on the existing C-mark. So when we get the head and neck data and hopefully a positive interim readout, that we could submit an extension use of the NBT-XR3 to go from STS to head and neck cancer patients. We will not start commercializing with soft tissue sarcoma because that will be globally detrimental to the whole franchise of MBTX artery. So the effort we have to deploy to make this product commercially available across Europe will not be interesting versus starting first with head and neck and obtaining a potential good price, a fair price for the product, and then extend it to the soft tissue sarcoma, and then start selling both in head and neck and STS. Now, as far as EIB is concerned on this topic, they're fully back on strategy on this, have Potential ongoing discussion we have talking about STS and the strategy to start with head and neck is seen by all our potential and existing collaborators as the right one to move forward.

speaker
John

All right, thank you. Thank you.

speaker
Operator

Thank you. There are no further questions at this time. I would now like to hand the call back over to management for any closing comments.

speaker
Craig West

Thank you. So I just would like to thank you all for participating to this call, and we look forward to further executing across the upcoming milestone, and we'll continue, of course, to keep you updated on our progress and hopefully and obviously much more clinical data that will come this year. Thank you very much. I wish you all a very good day.

speaker
Operator

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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