Earnings call transcript: NanoBiotics reports 2024 losses, looks to future

NanoBiotics (NASDAQ: NBTX) reported its financial performance for the full year 2024, revealing a significant rise in net loss and a drop in revenue due to strategic shifts in its research and development partnerships. The company’s stock, currently trading near its 52-week low with a market capitalization of $17.46 million, showed no immediate market reaction as trading was closed. According to InvestingPro analysis, NanoBiotics maintains relatively low price volatility with a beta of 0.81, suggesting more stable trading patterns than the broader market. The company is focusing on its innovative platforms and partnerships to drive future growth, with expectations of multiple clinical data readouts in 2025.

Key Takeaways

• NanoBiotics recorded a net loss of €68.1 million, a 72% increase from the previous year.
• Revenue fell to negative $7.2 million, primarily due to transferring study costs to Janssen.
• The company extended its cash runway to mid-2026, maintaining cash and cash equivalents at €49.7 million.
• Strategic focus on the CuraDigm nanotherapeutic platform and ongoing cancer trials.

Company Performance

NanoBiotics faced a challenging year in 2024, with a substantial increase in net loss and a decrease in revenue. The company’s financial performance was impacted by the transfer of the NanoRay 312 study costs to Janssen, resulting in negative revenue. Despite these setbacks, NanoBiotics remains committed to its strategic partnerships and innovative platforms, positioning itself for potential growth in the coming years. InvestingPro data reveals the company achieved impressive revenue growth of 40.16% in the last twelve months, with 8 additional key insights available to subscribers through their comprehensive Pro Research Report.

Financial Highlights

• Revenue: Negative $7.2 million (compared to $36.2 million in 2023)
• Net Loss: €68.1 million (72% increase year-over-year)
• R&D Expenses: €40.5 million (5% increase)
• Cash and Cash Equivalents: €49.7 million as of 12/31/2024

Outlook & Guidance

NanoBiotics is optimistic about its future, with plans to conclude recruitment for the NanoRay 312 study in 2025 and multiple clinical data readouts expected throughout the year. The company’s strong liquidity position is evidenced by a healthy current ratio of 2.71, as reported by InvestingPro. The company is also focusing on developing its CuraDigm platform and exploring non-dilutive financing options to support its growth strategy, while maintaining moderate debt levels.

Executive Commentary

CEO Laurent Levy emphasized the company’s progress towards financial sustainability and growth, stating, "We’re moving toward financial sustainability and growth." CFO Bart Van Rhine highlighted a disconnect between the enterprise value and market cap, suggesting potential undervaluation. Levy also expressed confidence in the company’s de-risked position, saying, "We are in a very de-risked situation right now."

Risks and Challenges

• Continued financial losses could strain resources and limit operational flexibility.
• Dependence on strategic partnerships, such as with Janssen, poses risks if collaborations face challenges.
• Regulatory hurdles and competition in the oncology space could impact market penetration.
• Cash runway extension to mid-2026 requires careful financial management to avoid liquidity issues.

NanoBiotics is navigating a complex landscape of financial challenges and strategic opportunities. The company’s focus on innovation and partnerships positions it for potential success, but it must carefully manage risks to achieve long-term growth.

Full transcript - Nanofilm Technologies Intl Ltd (NANO) Q4 2024:

Conference Operator: Good day, and welcome to the Nanobiotics Business Update and Full Year twenty twenty four Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers’ presentations, there will be a question and answer session. Please be advised that today’s conference is being recorded. At this point, I would turn the call over to Greg West, Senior Vice President of Investor Relations of Nanobiotics.

Please go ahead.

Greg West, Senior Vice President of Investor Relations, NanoBiotics: Thank you. Good afternoon and good morning and welcome to the NanoBiotics conference call to discuss our full year 2024 financial and operational results. Joining me on the call today are Laurent Levy, Co Founder and Chief Executive Officer and Bart Van Rhine, Chief Financial and Business Officer. As a reminder, today’s call is being webcast and will be available on our website for replay. On the next slide, Slide two, 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, amongst other things.

These forward looking statements are based on current information, assumptions, expectations that are subject to change. They are subject to significant risks and uncertainties that could cause the company’s actual results to differ materially from our current expectations. Accordingly, you are cautioned not to place undue reliance on forward looking statements. Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and SEC in The United States, which are available in the Investor Relations section of our website along with the press 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 for future circumstances. With that said, I’d like to

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: turn the call over to Laurent. Please go ahead. Thank you, Craig, and welcome, everyone. Today, we’re going to talk about the progress we’ve been making with NBTX R3 or JNJ1900, And also, we’ll give you some financial highlights and operational highlights for 2024 and 2025. And we will hand this call with a Q and A session.

We have made very good progress toward our pathway to sustainability and growth, and starting by continuing, pushing and developing this collaboration with J and J. In 2023, we’ve been signing this $2,600,000,000 deal plus royalties with G and J and now pushing into different directions and different indications. If you think about just the two first indications in lung cancer and head and neck cancer, those two first only could represent over one hundred thousand patients addressable in The US and EU 5 alone, which could lead to a potential $10,000,000,000 market. As you will see, we have many things ongoing and this collaboration is progressing well, but it’s not the only thing that would lead us to sustainability. There is also the new platform we are developing and this year we have been launching our new platform, first in class product with CuraDigm.

We will talk about that a bit later. But first, let’s move to the next slide and see how do we tend to address one of the largest untapped markets in oncology. Slide six, you can see our pipeline and as you will remember, NBTXR3, our product, is a product that is very versatile. A product that is tumor agnostic, patient agnostic and target agnostic, which means that we could literally combine that in many indications in oncology, as you can see in our pipeline. So, we’ve been progressing a lot this pipeline this year in different indications, including two very important ones: the NanoRed three twelve, which concerns elderly patients in head and neck that are frail and ineligible to Cisplatin, but also the Lung Stage three program that J and J started this year.

Let’s move to the key developments we’ve been doing, starting with NanoRed three twelve. This is our pivotal Phase three study in locally advanced head and neck cancer. It is a global study, 500 patients randomized one to one. What we’ve been doing in 2014 is first aligning on the transfer to J and J of this program and we did that midstream of the development of the NanoH312. Why we did it?

Because we thought it was the best thing possible to do with this study, rather than waiting the final data before transferring, which would have caused some delay post result, we said that it would be much better to do it now in order for Change Edge to be ready, assuming the data are positive, to push the return and start registration of the product. We expect to complete this transfer around Q3 of this year. So, that’s for the NanoRig three twelve, which is progressing and now being transferred to J and J. On the other side, J and J has started a new trial named CONVERGE. It is a randomized phase two study in unresectable stage three lung cancer and the first patient has been dosed in January.

And this trial progressed quite well. Moving to next slide. Those are not the two only developments or clinical developments that have progressed. We also have early stage studies that are progressing across solid tumors. Let’s start with head and neck recurrent and recurrent metastatic cancer patients that are eligible to PD-one.

So, our Phase one study 1,100 have been showing last year some positive data showing safety, feasibility and also very good disease control and tumor response. And we expect to give this year an update on this trial both on patients that are first line PD-one but also refractory to PD-one on the completion of these two cohorts. We’ve been also progressing in pancreatic cancer. That’s one of the trials we are doing with MD Anderson Cancer Center. It is about patients that are locally advanced or borderline resectable.

We’ve been completing the Phase one and got some really encouraging outcome in terms of safety profile of the product, but also in terms of efficacy. And as we’ve seen such good results for the Phase one, we decided with the NDA to expand into a new cohort, which this time will be the same treatment within the standard of care, meaning radiation plus chemo plus nanoparticle for pancreatic locally advanced cancer patients. This second cohort has started and recruiting well. We should expect also this year to get results from the escalation part and the expansion part of the trial before the summer. In lung cancer, we recently published some data coming also from MD Anderson Cancer Center.

They have completed the dose escalation part of a phase one in non small cell lung cancer that already received some previous treatment and that are eligible for re irradiation. So the data were really good in terms of safety and feasibility, again very consistent versus other trials we’ve been showing and we start to see even early some very interesting sign of efficacy, meaning local control of the tumor which is essential for those patients. So as you can see, we have been progressing the pipeline and will continue as we expect many more clinical data coming this year. In parallel to NBTX R3 or JNJ1900, we’ve been launched Curadigm, our fully owned next generation nanotherapeutic platform. This is based on nanoparticle and nanophysics and again something that we expect to be useful for many, many patients, millions of patients, but not only for one indication and one therapeutic area.

It is something that we expect to be used in many therapeutic areas in combination with many type of products. So as you may remember, those are nanoparticles that are designed to temporarily occupy the liver and while the liver is busy with those particles, when you inject something else in the patient, then the liver accumulation will be decreased and to a certain extent will completely change the bioavailability of the second product that you inject. So, this has a strong potential to increase efficacy or decrease toxicity of existing products. But where we think it could be really, really big is because we can create all new therapy with a unique competitive positioning, something that we work internally to start building our own pipeline. But as I mentioned, this is a technology that could be widely applicable and therefore this is an ideal candidate or candidates I should say to make potential multiple partnerships and that’s a strong activity we are leading this year talking to biotech and pharma industry.

On the top of progressing our collaboration and platform development, we also have added two new board observers to the Nanobiotics Board, Margaret and Annette, and we’d like to welcome them for the contribution also they already have brought to the company and the future contribution. We intend to confirm this observer and make them full member at the next General Assembly. That’s it for this party, and I’m now going to give the mic to Bart to give you some operational and financial highlights.

Bart Van Rhine, Chief Financial and Business Officer, NanoBiotics: Thank you, Laurent. Good morning and good afternoon, everyone. Moving to the next slide. As Laurent mentioned earlier, NanoBioxx has had an extremely productive year, and we’ve been executing our disciplined financial strategy to move the company towards long term sustainability and growth. Subsequent to our progress in 2023, in which we signed the license agreement with Johnson and Johnson and completed the follow on offering, recent activities include the receipt of the first milestone payment in May 2024 when we received the 20,000,000 payments related to NanoRay three twelve progress.

And continuing this execution, we announced last month the signing of an amendment to the global licensing agreement for MBTXR three. This amendment has several important provisions, including removing the vast majority of the nanobiotics funding obligation for NanoRay three twelve, releasing J and J from select future potential milestone payments, and safeguarding NanoBiox’s path to sustainable cash flow through hundreds of millions in potential milestone payments related to lead programs expected in the coming years. As a result of these changes to the license agreement, we have extended our cash runway to mid-twenty twenty six, and not to be missed, these changes should result in a meaningful reduction in cash burn beyond mid-twenty twenty six as the full cost of a phase three study will no longer be reflected in our financials. And we’re not done. We are continuing to actively explore further financing options, preferably non dilutive, to extend cash visibility into 2027.

This is rooted in the belief that our first platform provides a path for NanoBuildix to reach financial stability in the next few years. As we advance to the next slide, we show here the elements of the amended agreement over time. We can share with you what has transpired so far as well as our outlook, should data readouts and regulatory approvals come in positive. The left column represents elements of the agreements that occurred already or are ongoing. This includes the 80,000,000 already received made up of the upfront equity and the first milestone I mentioned previously.

There are many elements of the agreement ongoing, such as tech transfer, product supply, J and J investing in duplication of our manufacturing capabilities, and starting the randomized CONVERGE study in non small cell lung cancer. In the middle, you can see that there is 200,000,000 plus of medium term milestones that we expect in the next two to three years. This should lead to a sustainably financed company with the increased commitment from J and J. When we look at the right hand side of the slide, we can see that we maintain the royalties. We maintain the $220,000,000 per new indication developed by NanoBiolex, which would require funding by NanoBioxx, as well as more than 2,300,000,000.0 relating to long term milestones of the ongoing programs, development and regulatory milestones of potential additional indications, sales milestones that are indication agnostic, as well as the LEO Bio milestones for Greater China region.

I’ll describe these more in a moment. The settlement of these items allows Nano to focus on supporting J and J regarding the operational success of NanoA three twelve as reflected in the amendments. As we turn to the next slide, I wanted to share a recap of the overall structure post the amendment. We’ve presented this before, and these are post amendment numbers. As I already indicated, royalties have not changed, and the 105,000,000 in total has been removed from the first and third bucket from a milestone perspective.

The first bucket now reaches up to 1,770,000,000.00, and the third bucket, which was the LEO Bio bucket, now Jensen bucket, which is up to a hundred and 60 5 million versus 205,000,000 prior related to the Greater China region. In total, the agreement and rights assignment represent a potential of 2,600,000,000.0 in milestones with potential for additional milestones from indications we may develop and fund and will receive tiered royalties from the low teens to low twenties as percent of sales. Now let’s turn our attention to the full year 2024 financial highlights on the next slide. Negative revenue of $7,200,000 was recognized in 2024 compared to $36,200,000 for the year ended 12/31/2023. Significant revenue was recorded in 2023 in connection with the execution of the license agreement with Janssen, as well as the recognition of the NanoA three twelve development milestone.

The negative revenue impact recognized in 2024 results from the transfer of NanoA three twelve study sponsorship to Janssen signed at the end of twenty twenty four, which amounts to negative €19,300,000 revenue impact, which is driven by a one time recognition of a net liability towards Janssen to affect this new situation. This net liability is made up of the refund obligation the company has towards Janssen regarding the NanoA three twelve total remaining costs that will remain with the company, which is offset by residual contract liability and R and D services recognized in 2024. This net liability was recognized at the time of the execution of the amendment and is a result of the application of IFRS 15 revenue recognition accounting treatment, which generates a cumulative negative catch up. To be clear, this negative revenue amount is a noncash item and therefore does not impact Nano’s cash position. This one off negative impact is partially offset by other revenues recognized in 2024 that conversely do positively impact our cash position, including sales of clinical products, and supplies for €5,900,000, technology transfer services built to Janssen for 1,800,000.0, and research tax credits for 3,300,000.0.

R and D expenses consist primarily of preclinical, clinical, and manufacturing expenses related to development of MBTXR three and totaled €40,500,000 for the twelve month period ended 12/31/2024 as compared to 38,400,000.0 for the twelve months ended 12/31/2023. The 5% increase in net R and D expenses was primarily due to an increase of clinical development activities driven by the costs related to NanoA312 and the phase one multi cohort trial of RT activated MBTXR3 followed by anti PD-one checkpoint inhibitors, also known as Study 1,100, as well as the full year impact of R and D positions that were recruited in 2023. When we turn our attention to selling, general, and administrative expenses, these were €20,500,000 for the year ended 12/31/2024, compared to 22,000,000 for the year ended 12/31/2023. The 7% year over year decrease is mainly due to one off fees incurred in 2023 consisting of license agreement execution and equity issuance related legal expenses, next to one off fees paid to a financial advisor for €1,900,000 in total. Net loss attributable to shareholders was €68,100,000 a year over year increase of 72% or 1.44 per share for a twelve month period ended 12/31/2024, which is primarily attributable to the one off negative revenue recognition accounting impact, which again was a noncash item.

This compares to a net loss of 39,700,000.0 Euro or €1.00 8 per share for the year ended 12/31/2023. As we look at cash and cash equivalents, as of 12/31/2024, NanoBiotics had 49,700,000.0 in cash and cash equivalents compared to 75,300,000.0 Euro as of 12/31/2023. Based on the current operating plan and financial projections, NanoBiotics anticipates that the cash and cash equivalents of €49,700,000 as of 12/31/2024 will fund its operations into mid twenty twenty six. To conclude, we have a disciplined capital allocation approach, and our recently amended licensing deal arrived at a structure that puts the company on a path towards a sustainably financed company subject to milestones or regulatory approvals coming in positive. We are very excited regarding the potential of MBTXR3 or J and J 1,900 and are focused on bringing this first in class radio enhancer to the market together with our partner.

And now I will turn the call back to Laurent. Laurent?

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you Bart. Let’s see what’s coming in the next, eighteen months for nanobiotics. As you can see on slide 16, we expect to get a very important milestone next year and namely the end of recruitment of the ongoing phase three in head and neck. That should lead, assuming the data are positive, to potential registration. There’s also the stage three, randomized Phase two, in non small cell lung cancer that J and J has started that should start reading in a not too distant future.

But what’s coming for this year is more data and starting with the head and neck refractory patients that are eligible to PD-one, either as a first line or second line or third line treatment and we expect to get data on those two cohorts by the end of twenty twenty five. The non small cell lung cancer trial coming from the have been published just a few days ago, but there will be more coming from the MD Anderson Cancer Center, where we’ll have the full data of the pancreatic cancer phase one trial that should be published before mid year this year. And for the second part of the year, we’re waiting also the first data coming from the last cohort, coming from the 1,100 trial, which are patients that received multiple IO treatment and some others that got refractory and then we have injected our product plus radiation continuation of PD-one to see if we can rescue those patients and most of the patients here have been melanoma patients and we’re really eager to present this data. And finally, coming from the again, esophageal Phase I first data, we will start updating this program by the end of this year.

So, as you can see, there will be a lot to say from now to the end of the year, while awaiting some of the key important milestones in locally advanced head and neck cancer Phase III or Lung Stage III randomized Phase II run by J and J. In a nutshell, for today, what we would like to take away is, first of all, we’re moving forward with the partnership with J and J. It does evolve and progressing really well. We have continued also to show the potential and opening the potential of NBTX artery in multiple indications. This year, or last year, has been a good time to introduce our new platform, CuraDyme.

And equally importantly, not only we are growing our different options to develop products to help patients, but we’re really moving toward financial sustainability and growth for the company. And last year, we’ve been clearly strengthening our financial position. And finally, we’re coming with end of the year where we expect many more clinical readouts and more to come. So with that, I’ll conclude the first part and we’ll open the session for Q and A.

Conference Operator: Thank We are now going to proceed with our first question. The questions come from the line of Jonathan Chang from Leerink Partners. Please ask your question.

Yeander Li, Analyst, Leerink Partners: Hi, good morning. This is Yeander Li on for Jonathan Chang. Thanks for taking my questions. So I have two questions. So the first one, could you provide more details on the recently initiated Phase II COMPUTERGE study by J and J?

Specifically, when can we expect to see the initial data? And what factor gives you confidence in the study’s potential for success? Thank you.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you. Unfortunately, for now, we can’t tell anything more that the trial has started and progressing well, and we’ll come to our partner to define when will be the first readout of this trial. Now concerning the other part of the question about why this population and what should we expect and what do we think in BTX R3 could make a difference here, I think it’s in going to the continuation of having consistently showing very good local control induced by our product when combined with radiation. And in this specific population of locally advanced non small cell lung cancer, so stage three patient unresectable, that usually get the PACIFIC regimen, which is radiation, chemo, and followed by PD L1, assuming they did not progress in between, there’s still a low bar in terms of local response. And more generally in oncology, when you have good local response for locally advanced cancer patients with OpMed, then this translates into PFS and OS, what we have seen in head and neck, what we see in other indications.

So, clearly, the point here is to bring much better local control to those patients. So that’s the context of this randomized trial. Now what we start seeing across different indications, as I mentioned, show already a good local control brought by NBTX R3 and we think the recent data generated by MDA is also a good sign of what could happen in the CONVERGE study.

Yeander Li, Analyst, Leerink Partners: Understood. Thank you. Very helpful. And my second question is the upcoming pancreatic cancer data presentation. We’re curious how will the information presented there be different from the press release last year?

And if the results are promising, what would the next step be for MBTXR3 in this indication? Thank you.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you. So, end of last year, we announced the completion of the phase one that was including an escalation part and an expansion part and just gave the top line overall survival for the patient. So, what we should expect as a readout for this is the full data including efficacy, safety, some of the potential biomarker that have been used, so that the FDA is working on that aspect right now. There’s already a next step that has started when we announced that FDA approved an amendment to the protocol that is adding a new court. And this new court is about giving the full standard of care to patients.

Just as a reminder, the first part of the trial was patient that get chemo induction, then followed by radiation plus NBTX artery. Now, that’s not the full standard of care that those patients usually receive as they usually do chemo induction, radiation plus chemo. So in this expansion part, we have added the chemo on the top of radiation plus NBTXR3 and therefore should expect, according to the existing normal of action, a better synergy and even more efficacy than what we’ve been seeing in the first part of the trial. So, part of the trial is routine, and we will tell soon when we should expect data on that.

Yeander Li, Analyst, Leerink Partners: Thank you. Very helpful.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you.

Conference Operator: We are now going to proceed with our next question. And the questions come from the line of Sharon Hama from Jefferies. Please ask your question.

Sharon Hama, Analyst, Jefferies: Hi there. Thank you for taking my questions. Just on, I guess, what portion of costs are you still liable for for the NanoRay study? And what are they related to? And how much of it, if you can disclose?

Secondly oh, I appreciate this might be more J and J’s responsibility. But what’s the most recent communication you’ve had with FDA on the NanoRay program? I I think the recent shakeup in in the administration and and the FDA has caused concerns that some programs might be deprioritized or there may be sort of delays in meetings. So, what have you been hearing? Thank you.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you. So, maybe let me take the second question, then I’ll pass the mic to Bart to answer the first one. I mean, we interacted with FDA or other agencies on different matters and J and J is doing the same. As our program already well engaged, we don’t have experience, to the best of my knowledge today, any delayed in meetings or interaction. So things looks normal to date.

Bart Van Rhine, Chief Financial and Business Officer, NanoBiotics: Thank you, Laurent. Happy to follow on. Thank you, Sean, for the question. With regards to the remaining costs with NanoBioDX, that is relatively immaterial as we’ve guided the public. The vast majority of the costs are now with J and J that has taken over the obligation to fund, further to the exchange of milestones that we announced two weeks ago.

That may lead to, some payments in 2025, ’20 ’20 ’6, and 2027 that remain on our end, but they’re in the single digit millions in those respective years and are not impacting the cash runway in a meaningful way. We’ve guided the cash runway to mid-twenty twenty six, but the removal of the vast majority of this phase three trial cost will benefit us beyond mid-twenty twenty six, and that burn rate will come down if one takes a look at our annual R and D expense, of which the majority relates to the NanoRay three twelve directly or indirectly, one should expect that we will have a very attractive cost run rate post mid twenty twenty six. Thank you.

Conference Operator: We are now going to proceed with our next question. And the questions come from the line of Michael Schmidt from Guggenheim Securities. Please ask your question.

Michael Schmidt, Analyst, Guggenheim Securities: Hey, guys. Good morning. I just had a bigger picture question. So now that the NBTRx three program has essentially transitioned fully to J and J operationally and financially, I guess, as you think about the company longer term, what are some of the R and D initiatives internally at Nantibiotics that you think could create additional value longer term beyond NBTXR3?

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thanks, Michael, for the question. So, maybe first of all, let’s say that we’re not yet done with NBTXR3. We still have a lot to do. You’re fully right when you say that J and J now is is taking a good part, a majority of what is happening with NBTX artery, with the CONVERGE trial, with the transfer of the three twelve and so on. But this transfer is not yet done.

As we mentioned, should be in Q3 this year and there’s still a lot to do around the manufacturing, preclinical, around preparing everything that should go and will go in the dossier for registration. So outside the three twelve, which is today a big part of the investment in resources of nanobiotics that Node J and J is taking, there’s still a lot in parallel, and this, we think, will continue for the coming few years. Now, it is true that this shift of the three twelve is also opening some doors for us, not only because we are going to spend less money, but also we can free some resources to continue to work on our other platform and mainly the Curadyne platform, which is the platform we want to push after NBT XR3, which is a very broad applicable platform not only to potential early deal and partnership, but also to develop our new internal pipeline. But we expect to give more detail on that before the end of this year.

Michael Schmidt, Analyst, Guggenheim Securities: And so I think you mentioned earlier, but how much additional r and d spend in 2025 and 2026 will be on NBTXR three versus other programs?

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Bart, do you want to take that one?

Bart Van Rhine, Chief Financial and Business Officer, NanoBiotics: Yep, I was unmuting. So what will remain essentially is the 1,100 study, MD Anderson preclinical and discovery work, as well as Curadyne. Each of those are single digit millions, so the burn will come down quite significantly on the R and D side with three twelve study making up the majority of the R and D spend. So that is millions per quarter less. The beauty of the CuraDigm program is that, as explained to the market, it’s a platform that can be partnered, whether it’s with existing new drugs, or drugs that have failed.

So we expect that the burn will be very efficient in that regard. It will go up versus what it is now, but it will, on a net basis, with the removal of the phase three liability, you know, be significantly less on a net basis going forward.

Michael Schmidt, Analyst, Guggenheim Securities: Thank you.

Bart Van Rhine, Chief Financial and Business Officer, NanoBiotics: Thank you, Michael.

Conference Operator: We are now going to proceed with our next question. The questions come from the line of Saiyampakula Ramakanth from HCW. Question.

RK Ramakanth, Analyst, HCW Wainwright: Thank you. This is RK from HC Wainwright. Good afternoon, Ryan and and Bart. So a couple of quick questions here. So this is for Bart.

You know, you were talking about the the runway, which currently stands till mid mid twenty twenty six, and and you were also saying, you know, there are potential ways for you to extend it into ’27. So what what could be the the, you know, the potential non dilutive ways? And also, how much of a gap is there for you to fill so that you can take it up to 2027 or into 2027 from where it stands currently?

Bart Van Rhine, Chief Financial and Business Officer, NanoBiotics: Thank you, RK. So we feel that the enterprise value significantly disconnected with the market cap, therefore, dilutive options are not our preference. We have EIB debt in our cap structure, and adding more debt, we believe, is not the ideal way to go about things. But other non dilutive financing options such as royalty financing, we believe, hold good promise for the company given the type of asset this is. Just to remind, it’s a very versatile asset.

Laurent mentioned it in the call. It’s tumor agnostic, combination agnostic, target agnostic. We see significant engagement and investment by our partner J and J. We expect that to continue, so it is a very interesting asset for many of providers in that space. As our burn will come down quite significantly, we don’t need a lot of money, it would be low teens, to get into 2027.

It just behooves us at this point in time to remove the finance overhang and get into a safe harbor, because there’s tremendous value in this asset that needs to result in value creation for our shareholders. And we wanna make sure that we do that so that there’s no finance overhang and people can just appreciate the technology, the versatility of it, that is partnered with a partner that we believe is an ideal partner for this asset, and bring it hopefully in many indications, should data readouts be positive.

RK Ramakanth, Analyst, HCW Wainwright: Thank you for that, Bart. And then, Loraine, just thinking about our three for a second. Having seen the data that we have seen so far, both on the safety side and on the efficacy side, To me, that doesn’t seem a real reason why this should not get into the market. Granted, it may take a little bit of time, but there’s no reason to think that it should not get to the market. However, what could be the potentially the reasons why it cannot get to the market?

I was just thinking about it because based on what we know about the molecule, I feel quite confident, but other than the timing part of it. Are there any other things that, you know, I’m being blindsided?

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you, RK, for the question, the $10,000,000,000 question. Well, I think we could have had a different answer to this question depending on timing you would ask for it. In the past, we would have indicated manufacturing is always a risk. Getting some first randomized data is always a risk until you have them. Not having a partner to market the product or to make sure we can develop broadly would have been a risk, and many other things.

But I think where we stand now, I think all those usual big impacting impactful risk that the biotech is facing is behind us. So, I will say that we are in a very de risked situation right now. Now, there’s never a % guarantee in any of the things. So, I think what we should just do is wait. There’s not too much time to wait now to get to next big inflection point and to, on our side, help change it to move as fast as they can and to bring this product to market.

RK Ramakanth, Analyst, HCW Wainwright: Thank you for that. And then the last question from me is also on the CuraDigm asset. Probably I’ve asked this question in the past. What’s what’s the gating event that needs to get done so that, you know, you can initiate, you know, a clinical program? Is it is it resources or is it time time in the sense getting all the material together, you know, to start a program?

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Well, I think it’s essentially timing. We have enough resources to push this program. As Bart mentioned, at this stage of development it is, it does not cost a lot of money, but also, as we want to re emphasize the partnership activity on that, then there probably will be a big part of it that will be done on other times. So, we’re working on our internal pipeline and also have been starting interacting with many biotech and pharma. We have a good number of MTAs already signed on their way.

So, things are moving, and we hope that I will give much more info by the end of this year.

RK Ramakanth, Analyst, HCW Wainwright: Thank you. Thanks for taking all my questions.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thanks, RK.

Conference Operator: Thank you. We are now going to proceed with our next question. The questions come from the line of Eric Musunza from UBS. Please ask your question. Hello, Eric.

Your line is open. You may ask your question.

David, Analyst, UBS: Actually, this is David from UBS. Can you

Conference Operator: hear me?

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Yes, David.

David, Analyst, UBS: Yes. Great. Yeah, just actually two questions from me as well. So regarding the NANORADE three twelve trial, you know, so you’re planning to enroll patients with and without cetuximab. These patients who receive cetuximab will likely have a longer survival.

Could you help us understand what percentage of patients are going be enrolled with cetuximab and what percentage will not have cetuximab? And just curious if there’s going to be a cap in terms of patients who have the cetuximab background.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thanks, David. So, cetuximab is not the biggest used drug in head and neck when it comes to frail and elderly patients. Nevertheless, that’s something that is in the standard of care guideline, but when you look at it, not many people are using cetuximab. The reason why this drug has been added is because they are in the guidelines, so we need to leave the choice open for physicians to use it or not. So that’s one.

And in order to make sure that the trial is balanced and there is no bias, we’ve made cetuximab used as a stratification factor. So we should assume a balanced number of patients getting it in both arms. Now, why cetuximab is not used that much in those patients is because when you look at the detail of the Bonner paper, what you see is that for elderly people, cetuximab use is detrimental versus radiation alone. So, of course, looking at the overall data, you see a benefit for cetuximab, but this benefit is exclusively driven by younger patients. At the end of the day, we think that cetuximab in this trial will have either a neutral effect, we should not expect more efficacy coming from it, or a plus, a little plus.

But if there is some small benefit, we should assume that this benefit will be at the minimum equal in the arm with NBTX artery or better if we anticipate synergies. So, that’s why we don’t think cetuximab in this trial will play a key role.

David, Analyst, UBS: That’s really helpful. And then just another question on the upcoming data readout. There are many updates in 2025, including the Phase one data from the relapse metastatic and neck cancer in combination with PD-one. We just shared with us mechanistically, how do you think R3 will be additive to PD-one to exert better systemic benefit for those metastatic patients?

RK Ramakanth, Analyst, HCW Wainwright: Sure.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: First of all, before getting to the benefit of systemic activity of NBTX artery, just want to remind that for all patients getting PD-one, the first time they will get PD-one, they’re usually one third of those patients that are only locally relapsed, one third that would have local relapse plus MET, and a third only will have MET only. And most of the patients sixty percent I mentioned previously and beyond, they’re coming from the failure of previous lines of treatment. So, before getting into any systemic activity of NBTXR3, we should just remind that those patients getting PD-one, they also need and primarily need a local control. That’s what our PIs are mentioning quite repeatedly when we talk to them, that systemic control in head and neck metastatic patients or locally relapsed plus MET is good, but usually does not translate into direct link to PFS and overall survival. There’s always this need, an important need to control the local tumor and that’s where we know NBTX artery could play a key role first.

So even if we don’t look at the systemic effect, we have a strong potential to improve outcome for patients just based on local control. Now, when it comes to systemic, we’ve been proven in multiple studies with MD Anderson that when we combine artery to radiation versus radiation alone, we can trigger a much deeper systemic immune response with different mechanism and this has been fully extended, studied in preclinical model by James Welch. So, what we start seeing, and that’s part of what we would like to show in the next set of data we will explore for the 1,100, is really those two things: local control and systemic control. And we clearly see that it’s the magnitude of effect we see cannot just be linked to local control, not to what extent we have the systemic control, that’s something we are exploring.

David, Analyst, UBS: That’s really helpful. Thank you so much and congrats on the progress.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thanks David.

Conference Operator: There are no further questions at this time. I would like to turn the call over to Doctor. Levy for his closing remarks.

Laurent Levy, Co-Founder and Chief Executive Officer, NanoBiotics: Thank you. Listen. Thank you, everyone. It was another fruitful conversation. We’ll have plenty of news to deliver this year, so we’re gonna go back to work and prepare that for you.

Thank you for your attention, and I will wish you a a very good day. And let’s talk soon.

Conference Operator: Ladies and gentlemen, this concludes today’s conference today’s presentation. Thank you once again for your participation. You may now disconnect your lines. Thank you, and have a great day.

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